Journal of Physiotherapy 63 (2017) 182 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Trial Protocol A behaviour change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease: protocol for a randomised controlled trial Sonia Wing Mei Cheng a, Jennifer Alison a, Sarah Dennis a, Emmanuel Stamatakis b, Lissa Spencer c, Renae McNamara d, Susan Sims e, Zoe McKeough a a Discipline of Physiotherapy, The University of Sydney; b Charles Perkins Centre, School of Public Health, Prevention Research Collaboration, The University of Sydney; c Department of Physiotherapy, Royal Prince Alfred Hospital, Sydney Local Health District; d Department of Physiotherapy, Prince of Wales Hospital, South Eastern Sydney Local Health District; e Grow Mind and Body Coaching, The Sydney Children's Hospital Network (Randwick and Westmead), Sydney, Australia Abstract assessed by the activPAL3 activity monitor, and (2) feasibility of the intervention assessed by uptake and retention of participants, Introduction: Replacing sedentary behaviour with light intensity participant compliance, self-reported achievement of weekly goals, physical activity (ie, activities classified as less than three metabolic and adverse events. Secondary outcome measures will include equivalents, such as slow-paced walking) may be a more realistic functional exercise capacity, health-related quality of life, domain- strategy for reducing cardiometabolic risk in people with chronic specific and behaviour-specific sedentary time, patient activation, obstructive pulmonary disease than only aiming to increase levels of and anxiety and depression. Semi-structured interviews will be moderate-vigorous intensity physical activity. Behaviour change conducted with participants who receive the behaviour change interventions to reduce sedentary behaviour in people with chronic intervention to explore acceptability and satisfaction with the obstructive pulmonary disease have not yet been developed or tested. different components of the intervention. Analysis: Analysis of Research D_$qFT[I7] uestions: Is a 6-week behaviour change intervention covariance (ANCOVA) will be used to calculate between-group effective and feasible in reducing sedentary time in people with comparisons of total sedentary time and the number of bouts of chronic obstructive pulmonary disease? Design: This study will be a sedentary time > 30 minutes after adjusting baseline values. Uncer- multi-centre, randomised, controlled trial with concealed allocation, tainty about the size of the mean between-group differences will be assessor blinding, and intention-to-treat analysis, comparing a 6- quantified with 95% CI. Within-group comparisons will be exam- week behaviour change intervention aimed at reducing sedentary ined using paired t-tests and described as mean differences with time with a sham intervention in people with chronic obstructive 95% CIs. Secondary outcome measures will be analysed similarly. pulmonary disease. Participants and $[D_8Is]FT etting: Seventy participants The feasibility measures will be analysed descriptively. Semi- will be recruited from the waiting lists for pulmonary rehabilitation structured interviews will be conducted until data saturation is programs at Royal Prince Alfred Hospital and Prince of Wales achieved and there are no new emerging themes. De-identified Hospital, Sydney, Australia. Intervention: The behaviour change interview transcripts will be coded independently by two research- intervention aims to reduce sedentary time through a process of ers and analysed alongside data collection using the COM-B model guided goal setting with participants to achieve two target as a thematic framework. Discussion/sF[10_TD$I] ignificance: If behaviour behaviours: (1) replace sitting and lying down with light-intensity change interventions are found to be an effective and feasible physical activity where possible, and (2) stand up and move for method for reducing sedentary time, such interventions may be 2 minutes after 30 minutes of continuous sedentary time. Three face- used to reduce cardiometabolic risk in people with chronic to-face sessions and three phone sessions will be held with a obstructive pulmonary disease. An approach that emphasises physiotherapist over the 6-week intervention period. The ‘capability’, participation in light-intensity physical activity may increase the ‘opportunity’, ‘motivation’ and ‘behaviour’ (COM-B) model will be confidence and willingness of people with chronic obstructive applied to each participant to determine which components of pulmonary disease to engage in more intense physical activity, and behaviour (capability, opportunity or motivation) need to change in may serve as an intermediate goal to increase uptake of pulmonary order to reduce sedentary time. Based on this ‘behavioural diagnosis’, rehabilitation. the Behaviour Change Wheel will be used to systematically select appropriate behaviour change techniques to assist participants in Trial registration: Australian New Zealand Clinical Trials Registry. achieving their weekly goals. Behaviour change techniques will Date of trial registration: 8 November 2016. Registration number: include providing information about the health consequences of ACTRN12616001534471. Was this trial prospectively registered? Yes. sedentary behaviour, self-monitoring and review of weekly goals, Funded by: This research study is supported by a Physiotherapy Research problem-solving of barriers to achieving weekly goals, and providing Foundation Seeding Grant (2016). The principal researcher Sonia Cheng is feedback on sedentary time using the Jawbone UP3 activity monitor. supported by a Better Breathing Foundation scholarship. Funder approval Control: The sham intervention will consist of weekly _9D$[IFT]phone calls for number: S16-011. Anticipated completion date: March 2019. Prove- 6 weeks, to enquire whether the participants’ health status has nance: Not invitedIFD$T_]1.[ Peer reviewed. Correspondence: Dr Zoe McKeough, changed over the intervention period (eg, hospitalised for an acute Discipline of Physiotherapy, The University of Sydney, Australia. Email: exacerbation). No instructions regarding physical activity or exercise [email protected] will be given. Measurements: Outcomes will be assessed at baseline, at the end of the 6-week intervention period, and at the 3-month _F]TFD$I[126 ull protocol: Available on the eAddenda at http://dx.doi.org/10.1016/j. follow-up. Primary outcome measures will be: (1) total sedentary jphys.2017.04.001 time, including the pattern of accumulation of sedentary time, http://dx.doi.org/10.1016/j.jphys.2017.04.001 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 161–167 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research An app with remote support achieves better adherence to home exercise programs than paper handouts in people with musculoskeletal conditions: a randomised trial ]TMIREFSAT$ND[ ara EFIMRT]$DS[.EAN [DLS$]RUTNAME ambertRUS$DT[NME.]A a, MAELNTSRIF][D$ isa AMANTS[ERIF$.D] DNRETU[]H$SMA arveyRN$U]SE[TD.MA b,c, SRIT[AEF$NDC]M hristos$TF[EIR.NDAM]S ]AEM[ATNRUS$D vdalisET$MA[URN.]SD a, S$DNIFR[TLA]EM ydia WTED.$FIRSNAM][ ]ECANDTR[$SMU henD$E[RNAMU.TS] a, TA[]MDN$FESSIR ayanthinieFIRSTNA[$DME.] MTAREU]NJSD[$ eyalingamTSDU$][NAMRE. a, [ARE]TNDS$FIM Carin ATINFSE.]M[DRA$ DTR$S[P]EMANU ratt$DAME][SNRU.T a, RSTFNHEM$A[DI] olly JMAE.SRIF[TD$]N ][TEDMA$NRUSTatum[T]E.MA$NUDRS a, M]AET[J$FIDNRS ocelyn LRSNAIF$D.EMT[] RB[MATS$D]NUE owdenAD]N$TMER.S[U b,c, R[STIFAME]BN$D arbara R.ENTIM]SFRA[D$ UN$RE]DAT[LMS ucasNEU$.]DMSRA[T a a Physiotherapy Department, Royal North Shore Hospital; b John Walsh Centre for Rehabilitation Research, Sydney School of Medicine; c Kolling Institute, Royal North Shore Hospital, Sydney, Australia KEY WORDS ABSTRACT Patient compliance Question: Do people with musculoskeletal conditions better adhere to their home exercise programs Physical therapy modalities when these are provided to them on an app with remote support compared to paper handouts? Design: Exercise therapy Randomised, parallel-group trial with intention-to-treat analysis. Participants: Eighty participants with Mobile applications upper or lower limb musculoskeletal conditions were recruited to the trial. Each participant was prescribed a 4-week home exercise program by a physiotherapist at a tertiary teaching hospital in Australia. Participants were randomly assigned via a computer-generated concealed block randomisation procedure to either intervention (n = 40) or control (n = 40) groups. Intervention: Participants in the intervention group received their home exercise programs on an app linked to the freely available website www.physiotherapyexercises.com. They also received supplementary phone calls and motivational text messages. Participants in the control group received their home exercise programs as a paper handout. Outcome measures: Blinded assessors collected outcome measures at baseline and 4 weeks. The primary outcome was self-reported exercise adherence. There were five secondary outcomes, which captured functional performance, disability, patient satisfaction, perceptions of treatment effectiveness, and different aspects of adherence. Results: Outcomes were available on 77 participants. The mean between-group difference for self-reported exercise adherence at 4 weeks was 1.3/11 points (95% CI 0.2 to 2.3), favouring the intervention group. The mean between-group difference for function was 0.9/11 points (95% CI 0.1 to 1.7) on the Patient-Specific Functional Scale, also favouring the intervention group. There were no significant between-group differences for the remaining outcomes. Conclusion: People with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; however, the clinical importance of this added adherence is unclear. Trial registration: ACTRN12616000066482. [Lambert TE, Harvey LA, Avdalis C, Chen LW, Jeyalingam S, Pratt CA, Tatum HJ, Bowden JL, Lucas BR (2017) An app with remote support achieves better adherence to home exercise programs than paper handouts in people with musculoskeletal conditions: a randomised trial. Journal of Physiotherapy 63: 161–167] © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction Non-adherence to HEPs can be due to patient-related factors including low motivation, pain, poor self-efficacy, limited past Home exercise programs (HEPs) are an integral component of experience with exercise, and reduced social support. Also, the treatment for many different types of musculoskeletal conditions, benefits of HEPs may not be immediately recognised by patients.7 and are typically designed by physiotherapists to suit the Some researchers suggest that adherence to HEPs could be individual needs of patients during face-to-face sessions.1,2 These improved if physiotherapists increased their amount of face-to- HEPs are usually provided to patients on a paper handout.3 The face time with patients,8,9 but this is costly and rarely feasible given prescription of HEPs encourages patients to take responsibility for finite resources. Therefore, other solutions to improve adherence their rehabilitation and self-manage their conditions over the long and better utilise physiotherapy resources are needed. term.4 Adherence to these programs has been directly associated with improved patient outcomes;5,6 however, reports indicate that Whilst the research to date has addressed many patient-related up to 70% of patients do not perform HEPs as prescribed and that factors, little attention has been directed at evaluating different adherence tends to decline over time.6 modes of delivering HEPs and how this affects adherence. Those who have investigated the influence of mode of delivery on adherence http://dx.doi.org/10.1016/j.jphys.2017.05.015 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
162 Lambert et al: App delivery of home exercise programs have reported mixed results. For example, studies examining the use 2. Do people with musculoskeletal conditions report better of video or audio tapes to deliver HEPs have not demonstrated any function, more improvement in their condition, less disability added benefit over paper handouts or brochures.10–12 More recently, and greater satisfaction with healthcare service delivery when a randomised, controlled trial in an outpatient stroke population their HEPs are delivered through an app with remote support compared smart device technology (video and built-in reminder compared to paper handouts? functions) to paper handouts, and also failed to demonstrate any difference in adherence.13 In contrast, a randomised, controlled trial Method recently reported greater adherence to HEPs delivered through mobile phones with an internet-based self-monitoring system in Design patients with haemophilia-related knee dysfunction.14 A randomised, parallel group trial was undertaken in 80 people Given that more than 85% of Australians are internet users, with with upper or lower limb musculoskeletal conditions (Figure 1). an estimated 32 million mobile phone subscriptions,15 apps are The study commenced on 25 February 2016 and finished on potentially highly feasible for delivering and encouraging adher- 24 February 2017. Participants were randomly assigned via a ence to HEPs. Promising results have already been reported with computer-generated, concealed, fixed block randomisation proce- the use of apps to improve adherence and outcomes in other health dure to either intervention (n = 40) or control (n = 40) groups. areas, such as weight loss16 and diabetic management.17 There Intervention group participants received their 4-week HEPs on an could be several reasons for this success, including the potential for app with remote support, and control group participants received apps to send alerts, motivating messages or reminders.18 In their HEPs on paper handouts. Data were obtained prior to addition, it may be more convenient for patients to access their randomisation by treating physiotherapists, and then 4 weeks later HEPs via a mobile phone or device rather than a paper handout. A by blinded assessors. recent systematic review suggested that the ability of apps to include self-monitoring systems, for example an electronic log of Participants, therapists and centres completed exercises, could also increase adherence in people with chronic musculoskeletal pain.19 Furthermore, patients’ adherence Participants were recruited from patients receiving physiother- could be positively influenced by their knowledge that their apy for musculoskeletal conditions at Royal North Shore Hospital, physiotherapists can remotely monitor their adherence and Sydney, Australia. Patients were initially screened by one of nine provide feedback via an app. Therefore, this study aimed to experienced physiotherapists working in either the musculoskel- investigate the potential of an app to promote adherence to HEPs in etal outpatients, plaster room or hand therapy departments. They an effort to optimise patient outcomes. were included if they had an upper or lower limb injury or condition, had been provided with 4 weeks of home exercises by a Therefore, the research questions for this randomised, parallel- physiotherapist and were expected to complete these exercises at group trial were: least three times per week. Patients were only eligible for inclusion 1. Do people with musculoskeletal conditions better adhere to their HEPs when delivered through an app with remote support 1Ier)GiF([TD$u]g_ compared to paper handouts? Patients with upper or lower limb musculoskeletal conditions screened for inclusion (n = 108) Excluded (n = 28) • declined (n = 10) • limited English (n = 7) • scheduled physiotherapy within 4 wk (n = 4) • serious medical condition (n = 3) • aged <18 yr (n = 2) • expected hospital admission within 4 wk (n = 2) Week 0 Measured PSFS, WHODAS 2.0 Randomised (n = 80) (n = 40) (n = 40) Lost to follow-up (n = 3) Experimental Group Control Group Lost to follow-up (n = 0) • unable to contact (n = 1) • HEP on app • HEP on paper • refused follow-up (n = 1) • weekly SMS • withdrew before starting • phone call at Week handouts intervention (n = 1) 2 • phone call at Week 1 and/or Week 3 as indicated Measured self-reported adherence, PSFS, WHODAS 2.0, perceived global impression of Week 4 change, satisfaction with service delivery, assessor-reported adherence (n = 37) a (n = 40) a Figure 1. Design and flow of participants through the trial. HEP = home exercise program, PSFS = Patient-Specific Functional Scale, WHODAS 2.0 = World Health Organization Disability Assessment Schedule 2.0. a Indicates number of participants analysed for the primary outcome. Some data were missing for some secondary outcomes; see Tables 2 to 4 for details.
Research 163 if they: had access to a smart phone, tablet or computer with an from a paper copy of the original exercise program. The app was active email account; were aged over 18 and able to provide sent to participants within 1 day of randomisation by a link informed consent; were willing to participate; and were not embedded within an email or text message. The link opened their expected to require re-admission to hospital or further surgery individualised, web-based app. Subsequently, participants were during the trial period. Patients were excluded from the trial if phoned, informed that they were to use the app, given telephone they: were unlikely or unwilling to participate in the trial (for support as they installed the app, and instructed in its use. reasons such as serious medical conditions, cognitive impairment, Participants were advised to complete their exercises as recom- psychiatric illness or drug dependency); were scheduled to receive mended by their treating physiotherapist and to use the app to any face-to-face physiotherapy over the course of the trial; or had record adherence, which would be monitored remotely by the trial limited English. physiotherapist. They were instructed to dispose of the original paper handout of their HEP provided to them prior to randomisa- A person not involved in participant recruitment compiled a tion. All intervention group participants were phoned again at computer-generated, random allocation schedule. Participants’ 2 weeks, regardless of their adherence, to ensure that they allocations were placed in opaque, sequentially numbered and understood how to use the app and provide them with an sealed envelopes that were held offsite by an independent person opportunity to ask any questions. In addition, those participants to ensure that allocation was concealed. Upon successful patient who had not logged any activity on their app for 7 consecutive days screening and completion of the baseline assessment, an envelope were phoned at 1 week and/or 3 weeks to ensure they were not was opened and the group allocation was revealed. At this point experiencing difficulties using the app and to encourage them to do the participant was considered to have entered the trial. their exercises. The trial physiotherapist also sent out weekly motivational text messages to all participants in the intervention Whilst it was not possible to blind participants, every effort was group stating ‘keep up the hard work’, ‘have you logged your exercises made to keep participants naïve to the details of the two groups. on yourapp today?’, or ‘well done completing 4 weeks of home exercises’. For example, at the time of recruitment, participants were only told that they might receive their HEPs in an alternative way to Control group their paper handouts. They were not given any further details as to Participants allocated to the control group continued with their how the HEPs would be delivered or if one method was deemed superior to another. prescribed HEPs using the original paper handouts provided to them by their treating physiotherapist prior to randomisation. Intervention Participants in the control group did not receive any encourage- ment or feedback about their progress, and were not contacted All participants were prescribed a 4-week HEP by their treating again until their 4-week follow-up assessment. physiotherapist prior to randomisation. Typically, three to six exercises were prescribed and participants were instructed to Outcome measures complete the exercises at least once a day, three to seven times per week. The most commonly prescribed exercises were simple range Assessments were taken at baseline (Week 0) for two outcomes of motion, strengthening and proprioception exercises. The details and 4 weeks after randomisation for all outcomes by experienced of the HEPs were not changed for participants of either group after and blinded physiotherapists. The baseline assessments were randomisation. The only differences between the two groups were conducted through a face-to-face interview and the 4-week the mode in which the exercises were provided to participants and assessments were performed through a combination of telephone the additional telephone and text support provided to participants interview and online survey. Participants were instructed not to in the intervention group. reveal their allocation group or method of HEP delivery to the assessor during their telephone interview at 4 weeks. There were Intervention group one primary and five secondary outcomes. Participants allocated to the intervention group received their Primary outcome HEPs on an app associated with www.physiotherapyexercises.com, Self-reported exercise adherence: Participants were asked at which is free web-based software used by physiotherapists worldwide for a multitude of conditions (see Figure 2). The follow-up to rate their adherence to their HEPs over the 4 weeks exercises delivered through the app were identical to the exercises since randomisation on a numerical scale ranging from 0 = ‘never prescribed by each patient’s treating physiotherapist prior to performed my exercises’ to 10 = ‘always performed my exercises’. This method of capturing adherence was selected because there are few r[(Figure_2)TD$IG] andomisation; however, the trial physiotherapist generated them alternative ways of determining adherence that does not involve full-time surveillance.1,20 A similar tool has been used in previous clinical trials examining exercise adherence in musculoskeletal populations21 but psychometric testing has not been performed. Numerical rating scales such as this have also been widely used in medication adherence trials, and have good validity and reliabili- ty.22 A between-group difference of 2/11 points was deemed to be the minimum worthwhile treatment effect prior to commence- ment of the study, based on the consensus of several expert physiotherapists after taking into account the potential benefits of increased adherence to HEPs. Figure 2. Example of home exercise program provided on the free Secondary outcomes www.physiotherapyexercises.com app. The Patient-Specific Functional Scale (PSFS): This is a valid and reliable tool that is widely used by physiotherapists. It allows participants to report on their function at baseline and follow-up.23 At baseline, participants were asked to identify up to three activities that they found difficult to perform as a result of their condition. Participants were then asked to rate each of their identified activities on a numerical scale ranging from 0 = ‘unable to perform activity’ to 10 = ‘able to perform activity at the same level
164 Lambert et al: App delivery of home exercise programs as before the injury or problem’. At 4 weeks, the participants were Data analysis asked to rate their current abilities performing the same activities they had identified at baseline. Analysis was conducted on the A sample size of 80 participants was pre-determined based on mean of scores for the nominated activities, with higher scores a minimum worthwhile treatment effect of 2/11 points and likely reflecting greater function. SD of 3 points for self-reported exercise adherence,28,29 respec- tively, an alpha of 0.05, and a worst-case scenario of loss to follow- The World Health Organization Disability Assessment Schedule up of 10%. All analyses were conducted on an intention-to-treat (WHODAS) 2.0: This was used to determine degree of disability basis. Between-group comparisons were conducted using linear based on 12 items capturing mobility, self-care and community regression. Baseline scores for the PSFS and WHODAS (Week 0) participation.24 The simple scoring method was utilised, providing were included in the model to increase statistical precision. A post- a total score out of 48 points,25 with higher scores reflecting greater hoc sensitivity analysis was performed on the primary analysis to disability. These data were collected at baseline and follow-up. ensure the findings were robust to the assumption of normality. For this purpose, the analysis on the primary outcome was Perceived global impression of change: This score was obtained at repeated using a Wilcoxon Signed Rank Test, which is a non- follow-up by asking participants to ‘Rate the change in your condition parametric test that makes no assumptions about the distribution over the past 4 weeks’. Participants were provided with a numerical of the data. Details of the statistical analysis plan are presented in scale ranging from 0 = ‘a great deal worse’ to 10 = ‘a great deal better’. the study protocol, which is available in Appendix 1 (see eAddenda Global change scales are considered relevant instruments that are for Appendix 1). The code used to conduct the analyses in the sensitive to change in both clinical and research settings.26 statistical software is presented in Appendices 2 and 3 (see eAddenda for Appendices 2 and 3). Patient satisfaction with healthcare service: This was deter- mined by asking the following two questions at follow-up: ‘How Results satisfied have you been with the delivery of your home exercise program over the past 4 weeks?’ and ‘How satisfied have you been with Flow of participants through the study the support you have received over the past 4 weeks?’ Participants were instructed to rate their satisfaction on a numerical scale A total of 108 patients were screened for inclusion over the ranging from 0 = ‘not at all satisfied’ to 10 = ‘extremely satisfied’.27 duration of the trial. Of these, 80 were eligible and willing to Responses to the two questions were analysed separately. participate and were subsequently randomised into two similar groups. The flow of participants through the trial is illustrated in Assessor-reported exercise adherence: The blinded assessor Figure 1. Table 1 outlines the participants’ baseline characteristics. scored this over the phone at follow-up after asking the Females represented 65% of those recruited to the trial. Partici- participants any questions deemed appropriate to formulate an pants were 18 to 88 years of age, with a mean age of 48 years (SD opinion regarding the adherence of participants to their HEPs. The 17). Fractures were the most commonly treated conditions (n = 37, blinded assessor then provided a score on a numerical scale in 46%) and the majority of participants experienced a median pain response to the question ‘How adherent do you think the participant intensity of 3/10 (IQR 1 to 5) whilst performing their prescribed has been with his/her home exercise program over the last 4 weeks?’ HEPs. The scale ranged from 0 = ‘never did his/her exercises’ to 10 = ‘always did his/her exercises’. Compliance with the study protocol In addition to the above outcome measures, data were collected Compliance with the study intervention was excellent, with 39/ from the intervention group for descriptive purposes. Nine 40 intervention group participants receiving and accessing their questions were asked to capture participant satisfaction with HEPs via the app. One participant from the intervention group the app and any barriers to its use, with five possible answers dropped out of the study before commencing the intervention. ranging from ‘strongly agree’ to ‘strongly disagree’. Eight intervention group participants were contacted at either 1 or 3 weeks post randomisation because they had not logged activity The success of blinding was determined after completion of on their app in the preceding 7 days. the 4-week follow-up assessments, by asking the assessors if participants had revealed their group allocation or if they had been unblinded in any other way. Additionally, the naïvety of participants to the hypothesis of the trial was also assessed at 4 weeks. Specifically, participants were asked ‘Do you think you were allocated to the better group?’ They were given three possible answers: ‘yes,’ ‘no’ or ‘unsure’. Table 1 Baseline characteristics of participants. Characteristic Exp Con (n = 40) (n = 40) Age (yr), median (IQR) Gender (M:F), n (%) 56 (34 to 59) 47 (35 to 58) Time since injury/condition onset (mth), median (IQR) 13 (33): 27 (68) 15 (38): 25 (63) Site of injury/condition, n (%) 4.5 (3.3 to 7.9) 5.3 (2.0 to 6.3) upper limb 23 (58) 17 (43) lower limb 17 (43) 23 (58) Injury/condition type, n (%) fracture 19 (48) 18 (45) elective surgery (eg, TKR, ACL reconstruction) 7 (18) 9 (23) soft tissue injury (eg, ankle sprain, rotator cuff tear) 10 (25) 10 (25) other (eg, osteoarthritis) 4 (10) 3 (8) Face-to-face physiotherapy contacts within prior 3 mth, n (%) 1 7 (18) 4 (10) 2 to 5 19 (48) 24 (60) 6 to10 14 (35) 9 (23) > 10 Regular exercise (>30 mins 3 x weekly) at baseline, n (%) 0 (0) 3 (8) Pain VAS during prescribed exercise (0 to 10), median (IQR) 32 (80) 28 (70) 3 (0.75 to 5) 2.5 (1 to 5) Some percentages do not tally to 100 due to rounding. ACL = anterior cruciate ligament, Con = control group, Exp = experimental group, F = female, M = male, TKR = total knee replacement, VAS = visual analogue scale.
Research 165 Table 2 Mean (SD) of groups and mean (95% CI) difference between groups for all outcomes measured only at Week 4. Outcome Exp Con Exp minus Con (n = 37) (n = 40) Self-reported exercise adherence (0 to 10) 1.3 7.8 6.5 (0.2 to 2.3) Perceived global impression of change (0 to 10) (2.2) (2.4) 7.9 7.4 0.5 Patient satisfaction with healthcare service (0 to 10) (1.6)a (1.9)b (–0.3 to 1.3) satisfaction with service delivery 8.8 8.5 0.3 satisfaction with support received (1.6) (1.8)b (–0.5 to 1.1) 8.5 Assessor-reported exercise adherence (0 to 10) (1.9)a 8.1 0.5 7.0 (2.4)b (–0.5 to 1.5) Con = control group, Exp = experimental group. (2.2)c a n = 35. 6.7 0.3 b n = 39. (1.9)b (–0.6 to 1.3) c n = 36. Post-intervention data were missing for three participants on the WHODAS 2.0 (95% CI –2.9 to 1.7), perceived global impression the primary outcome. This was mostly due to participants not of change (95% CI –0.3 to 1.3), patient satisfaction with healthcare being contactable at 4 weeks or declining to complete follow-up service-delivery (95% CI –0.5 to 1.1), patient satisfaction with assessments. In addition, data were missing for between five and healthcare service-support (95% CI –0.5 to 1.5) or assessor- eight participants for the secondary outcomes (see Tables 2 and 3) reported exercise adherence (95% CI –0.6 to 1.3) scores. and descriptive data (see Figure 3) due to participants declining to complete these items. Sometimes the 4-week assessment was The results of descriptive data collected from intervention conducted later than intended and consequently occurred a group participants regarding their satisfaction with the app and its median of 5 weeks (IQR 5 to 6) after randomisation. The only use are depicted in Figure 3. Most participants either strongly reported adverse events were pain during exercise (n = 26); agreed or agreed with all nine domains of the questionnaire. For however, this was reported by the same participants at baseline example, 87% of respondents found the app useful and 90% felt and occurred equally within both intervention and control groups. they would use the app to view their HEP again in the future. With regard to blinding, assessors were inadvertently unblind- Discussion ed in nine instances at follow-up. With regard to maintaining participant naïvety about which intervention was anticipated to be It is believed that this is the first randomised, controlled trial to superior, 58% of the experimental group and 18% of the control examine the effect of using an app on adherence to HEPs in patients group indicated that they believed they were in the superior group, with musculoskeletal conditions.4 In addition, there has been little with most of the remaining participants indicating that they were high-quality research to establish the effectiveness of such unsure. technology in the field of physiotherapy, despite a rapid uptake of apps within the health community.30 Our study examined the Effect of HEPs provided on an app with remote support effectiveness of delivering HEPs on an app in combination with text messaging and phone calls, with the intention of answering a The results for all outcomes, including between-group differ- pragmatic question about the effectiveness of a ‘package’ of ences, are displayed in Tables 2 and 3. Individual participant interventions compared to paper handouts. Studies have shown outcome data are presented in Table 4 (see eAddenda for Table 4). that telephone coaching and text messaging have the ability to elicit behaviour change, which may encourage adherence21 and Primary outcome improve health outcomes.31 Therefore, it is not possible to know The mean between-group difference for self-reported exercise whether the same results would have been obtained if the effectiveness of the app alone had been compared to paper adherence was 1.3/11 points (95% CI 0.2 to 2.3) in favour of the handouts. intervention group. This result was also statistically significant with the post-hoc Wilcoxon Signed Rank test (p = 0.01). The results of this study (Tables 2 and 3) indicate that participants who received their HEPs on an app with remote Secondary outcomes support reported greater adherence and greater improvements in There was a statistically significant between-group difference function compared to participants who received paper handouts. A minimum worthwhile treatment effect of two points in self- for the PSFS, with a mean between-group difference of 0.9/11 reported adherence was articulated prior to commencement of the points (95% CI 0.1 to 1.7) in favour of the intervention group. study, yet the 95% CI associated with the mean between-group However, there were no significant between-group differences for Table 3 Mean (SD) of groups, mean (SD) within-group difference and mean (95% CI) between-group difference for all outcomes measured at Week 0 and Week 4. Outcome Groups Within-group difference Between-group difference Week 0 Week 4 Week 4 minus Week 0 Week 4 minus Week 0 Exp Con Exp Con Exp Con Exp minus Con (n = 40) (n = 40) (n = 36) (n = 39) (n = 36) (n = 39) PSFS 4.4 4.6 7.2 6.4 2.7 1.8 0.9 (0 to 10) (1.9) (1.9) (2.1) (2.0) (0.1 to 1.7) WHODAS 2.0 6.9 7.9 (1.6) 6.5 (2.2) –1.5 (0 to 48) (5.4) (6.1) (6.5) (5.5) –0.6 5.1 –1.5 (–2.9 to 1.7) (5.1)a (5.0)a Con = control group, Exp = experimental group, PSFS = Patient-Specific Functional Scale, WHODAS 2.0 = World Health Organization Disability Assessment Schedule 2.0. a n = 35.
]GIF$DT)3erugi([_166 Lambert et al: App delivery of home exercise programs I would use the physiotherapy exercises app to record my exercise progress in the future I would use the physiotherapy exercises app to view my exercise program in the future The text accompanying the exercises Strongly described the exercises well agree Agree The diagrams illustrating the exercises were No clear and demonstrated the exercises well opinion Disagree The physiotherapy exercises app Strongly worked well on my phone disagree I would recommend the physiotherapy 100% exercises app to my friends The physiotherapy exercises app was easy to use Having my physiotherapy exercise program on my phone or tablet is a good way to keep track of my exercises I think it is useful to have my physiotherapy exercise program on my phone or tablet 0% 20% 40% 60% 80% Percentage of participants Figure 3. App satisfaction survey responses from intervention group participants (n = 32). difference spanned this value (95% CI 0.2 to 2.3). Therefore, there is the clinical importance of these increases is unclear. This uncertainty about the clinical importance of the added adherence uncertainty probably should not discourage the use of apps for with the intervention. Similarly, there is uncertainty regarding the HEPs, given that physiotherapists can use freely available online improvements in function. So together, these two sets of results do software at www.physiotherapyexercises.com to generate individ- not provide convincing evidence about the superiority of HEPs ualised apps for their patients and users report high levels of provided on apps. Whether these increases in adherence and satisfaction with it. In addition, generating individualised HEPs function are worth pursuing will ultimately depend on various with the online software is probably quicker and easier than patient, clinician and circumstantial factors, for example, patients’ reproducing the equivalent with paper handouts (once therapists and therapists’ computer literacy and access to mobile devices. have learnt how to use the software) and provides a more professional-looking HEP that patients and therapists can use to Importantly, the intervention group participants reported high record and monitor adherence, respectively. Regardless, there is levels of satisfaction with the app. Nearly 90% of participants still scope for further research about the potential benefits of apps strongly agreed or agreed with the nine statements about the app and other similar technology for encouraging adherence to HEPs posed to them (see Figure 3). Of course, these data are only and understanding the effects on patient outcomes. descriptive and may have been vulnerable to bias. Nonetheless, participants’ perceptions about the benefits of using technology What is already known on this topic: Home exercise should be considered, particularly if HEPs can be provided through programs are commonly prescribed on paper for people with apps at no direct cost. musculoskeletal conditions. Adherence to these programs is typically low. In the absence of any satisfactory alternate measure, the study What this study adds: People with musculoskeletal condi- relied on participants’ self-reports of adherence. The limitations of tions who receive their home exercise program on an app with self-report are recognised, in that individuals may overestimate (or remote support reported greater adherence and greater underestimate) their own adherence.20 This would be problematic improvements in function than when paper handouts were if one group were to systematically overestimate (or underesti- used. It remains uncertain whether this effect on adherence is mate) compared to the other. To guard against this, we attempted clinically worthwhile. This uncertainty should not discourage to keep all participants naïve to the specific purpose of the study the use of the app for home exercise programs, given that it: is and to the modes of delivery; however, participants were aware freely available, has high user satisfaction, permits adherence that we were comparing two modes of providing HEPs. The monitoring, and is quick and easy to use. effectiveness of keeping participants naïve to the details of the study was tested by asking them at follow-up whether they felt eAddenda: Table 4 and Appendices 1, 2 and 3 can be found they had been allocated to the superior group: 58% of the online at http://dx.doi.org/10.1016/j.jphys.2017.05.015. intervention participants and 18% of control participants indicated that they believed they were in the superior group, with most of Ethics approval: The Northern Sydney Local Health District the remaining participants indicating that they were unsure. These Ethics Committee approved this study. All participants gave findings suggest that we were not very successful at keeping written informed consent before data collection began. All participants naïve to what was deemed the superior intervention, applicable institutional and governmental regulations concerning and this may have introduced bias. the use of human volunteers were followed. In summary, providing HEPs on an app in combination with Competing interests: Professor Lisa Harvey is the senior project remote support increases adherence and function compared to manager of www.physiotherapyexercises.com paper handouts for people with musculoskeletal conditions, but
Research 167 Source(s) of support: The research was funded by a grant from 13. Emmerson KB, Harding KE, Taylor NF. Home exercise programmes supported by the Ramsay Research and Teaching Fund, Australia. In-kind support video and automated reminders compared with standard paper-based home was provided by the Royal North Shore Hospital Physiotherapy exercise programmes in patients with stroke: a randomized controlled trial. Clin Department. Rehabil. 2016. 0269215516680856. Acknowledgements: We would like to thank the staff of the 14. Goto M, Takedani H, Haga N, Kubota M, Ishiyama M, Ito S, et al. Self-monitoring Royal North Shore Hospital Physiotherapy Department and the has potential for home exercise programmes in patients with haemophilia. John Walsh Centre for Rehabilitation Research, in particular: Gary Haemophilia. 2014;20:e121–e127. Rolls, Deborah Taylor, Patricia Evans, Raymond Jongs, Isaac Cockroft, Susan Chance, Katrina Ferguson, Joanna Prior, Rysia 15. International Telecommunication Union. ICT Statistics. 2016. http://www.itu.int/ Pazderski, Christina Mills, Joanne Glinsky and Mohit Arora. We also en/ITU-D/Statistics/Pages/default.aspx. Accessed 06/09/2016 wish to thank Catherine Sherrington from The George Institute for Global Health and Peter Messenger for his ongoing support of 16. Cotter AP, Durant N, Agne AA, Cherrington AL. Internet interventions to support www.physiotherapyexercises.com. lifestyle modification for diabetes management: A systematic review of the evi- dence. J Diabetes Complications. 2014;28:243–251. Provenance: Not invited. Peer reviewed. Correspondence: Lisa Harvey, John Walsh Centre for Rehabili- 17. Hutchesson MJ, Rollo ME, Krukowski R, Ells L, Harvey J, Morgan PJ, et al. eHealth tation Research, Kolling Institute, Northern Sydney Local Health interventions for the prevention and treatment of overweight and obesity in adults: District, Sydney, Australia. Email: [email protected] a systematic review with meta-analysis. Obes Rev. 2015;16:376–392. References 18. Buller DB, Borland R, Bettinghaus EP, Shane JH, Zimmerman DE. Randomized trial of a smartphone mobile application compared to text messaging to support smoking 1. Spetch LA, Kolt GS. Adherence to sport injury rehabilitation: implications for sports cessation. Telemed J E Health. 2014;20:206–214. medicine providers and researchers. Phys Ther Sport. 2001;2:80–90. 19. Jordan JL, Holden MA, Mason EE, Foster NE. Interventions to improve adherence to 2. Bassett SF, Prapavessis H. A test of an adherence-enhancing adjunct to physiother- exercise for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. apy steeped in the protection motivation theory. Physiother Theory Pract. 2010;1:CD005956. 2011;27:360–372. 20. Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of 3. Schneiders AG, Zusman M, Singer KP. Exercise therapy compliance in acute low measures of self-reported adherence to unsupervised home-based rehabilitation back pain patients. Man Ther. 1998;3:147–152. exercise programmes, and their psychometric properties. BMJ Open. 2014;4: e005044. 4. Peek K, Sanson-Fisher R, Mackenzie L, Carey M. Interventions to aid patient adherence to physiotherapist prescribed self-management strategies: a systematic 21. Bennell KL, Campbell PK, Egerton T, Metcalf B, Kasza J, Forbes A, et al. Telephone review. Physiotherapy. 2015;102:127–135. coaching to enhance a home-based physical activity program for knee osteoarthri- tis: a randomized clinical trial. Arthritis Care Res. 2017;69:84–94. 5. Pisters MF, Veenhof C, de Bakker DH, Schellevis FG, Dekker J. Behavioural graded activity results in better exercise adherence and more physical activity than usual 22. Williams CM, Maher CG, Latimer J, McLachlan AJ, Hancock MJ, Day RO, et al. Efficacy care in people with osteoarthritis: a cluster-randomised trial. J Physiother. 2010; of paracetamol for acute low-back pain: a double-blind, randomised controlled 56:41–47. trial. The Lancet. 2014;384(9954):1586–1596. 6. Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and inter- 23. Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient- vention-related factors associated with adherence to home exercise in chronic low specific functional scale: psychometrics, clinimetrics, and application as a clinical back pain: a systematic review. Spine J. 2013;13:1940–1950. outcome measure. J Orthop Sports Phys Ther. 2012;42:30–42. 7. Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in 24. Andrews G, Kemp A, Sunderland M, Von Korff M, Ustun TB. Normative data for the physiotherapy outpatient clinics: a systematic review. Man Ther. 2010;15:220–228. 12 item WHO Disability Assessment Schedule 2.0. PloS one. 2009;4:e8343. 8. Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical 25. Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, et al. therapy. Phys Ther. 1993;73:771–782. Developing the World Health Organization Disability Assessment Schedule 2.0. Bulletin of the World Health Organization. 2010;88:815–823. 9. Reilly K, Lovejoy B, Williams R, Roth H. Differences between a supervised and independent strength and conditioning program with chronic low back syn- 26. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of dromes. J Occup Med. 1989;31:547–550. strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17:163–170. 10. Schoo AMM, Morris ME, Bui QM. The effects of mode of exercise instruction on compliance with a home exercise program in older adults with osteoarthritis. 27. Henschke N, Wouda L, Maher CG, Hush JM, van Tulder MW. Determinants of patient Physiotherapy. 2005;91:79–86. satisfaction 1 year after presenting to primary care with acute low back pain. Clin J Pain. 2013;29:512–517. 11. Sacomori C, Berghmans B, Mesters I, de Bie R, Cardoso FL. Strategies to enhance self- efficacy and adherence to home-based pelvic floor muscle exercises did not 28. Wahi Michener SK, Olson AL, Humphrey BA, Reed JE, Stepp DR, Sutton AM, et al. improve adherence in women with urinary incontinence: a randomised trial. J Relationship among grip strength, functional outcomes, and work performance Physiother. 2015;61:190–198. following hand trauma. Work. 2001;16:209–217. 12. Lysack C, Dama M, Neufeld S, Andreassi E. Compliance and satisfaction with home 29. Evans L, Hardy L. Injury rehabilitation: a goal-setting intervention study. Res Q exercise: a comparison of computer-assisted video instruction and routine reha- Exerc Sport. 2002;73:310–319. bilitation practice. J Allied Health. 2005;34:76–82. 30. Burke LE, Ma J, Azar KMJ, Bennett GG, Peterson ED, Zheng Y, et al. Current science on consumer use of mobile health for cardiovascular disease prevention: a scientific statement from the American Heart Association. Circulation. 2015;132: 1157–1213. 31. Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, et al. Effect of lifestyle- focused text messaging on risk factor modification in patients with coronary heart disease: a randomized clinical trial. JAMA. 2015;314:1255–1263.
Journal of Physiotherapy 63 (2017) 131 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Call for applications for membership of the Editorial Board The Editorial Board currently consists of 12 members: eight local and four international. Applications are invited to fill the following Editorial Board vacancies beginning in 2018: two local four international. All incumbents are entitled to re-apply. Editorial Board members are given portfolios with substantial responsibilities. Potential applicants who are not prepared to take on portfolio responsibilities should not apply. The initial term of office commences on 1 January 2018 and expires on 31 December 2020. Editorial Board members are entitled to renominate for a further two successive terms. Knowledge and skills required: 1. broad understanding of research methods 2. extensive experience in publication of research 3. excellent written communication skills 4. good working knowledge of the physiotherapy profession and an interest in its future. To be eligible to apply, Australian applicants must: 5. hold a PhD 6. be a physiotherapist registered in Australia 7. be a financial member of the Australian Physiotherapy Association (APA). To be eligible to apply, international applicants must: 5. hold a PhD 6. have authority to practise in their own country 7. be a financial member of a WCPT member organisation. Responsibilities: contribute to the establishment of policies that guide the publication of the journal participate in the activities of the Editorial Board as a voting member attend regular Editorial Board teleconferences and a two-day face-to-face meeting (international members participate electronically where feasible) meet and liaise with other members of the Editorial Board and the journal Editor as required undertake specific tasks from time to time to promote the standing of the journal manage one of the journal portfolios. This might involve, for example, soliciting submissions and editing contributions for one of the journal’s ‘Appraisal’ sections ensure that the journal meets the needs of the APA membership and the physiotherapy profession. To be considered, physiotherapists applying for positions must submit: 1. a cover letter addressing the numbered criteria, above 2. a brief CV, which includes a clear explanation of the impact of any career interruption(s) over the last 5 years. Applicants will be assessed against the knowledge and skills listed above and potentially against other criteria. Applications close 5.00 pm AEST, Friday 29 September 2017 and should be directed to Marko Stechiwskyj at marko.stechiwskyj@ physiotherapy.asn.au http://dx.doi.org/10.1016/j.jphys.2017.06.001 1836-9553/
Journal of Physiotherapy 63 (2017) 189–190 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Correspondence Critical appraisal leaves our upper limb therapy intervention trial misrepresented We have recently come across a critical appraisal and in addition to our open access published paper we have produced a commentary1,2 published in the Journal of Physiotherapy regarding lay summary http://www.scope.org.uk/Support/Professional/ our published trial3 comparing action observation and repeated Medical/Play, which clearly states the trial findings, and a website practice with repeated practice alone in children age 3 to 10 years https://research.ncl.ac.uk/hemiplegiaresearch- fungames/ provid- with unilateral cerebral palsy. We were disappointed to find that ing free access to materials for parents to use and therapists to our trial was misrepresented. The title of the synopsis should suggest as supplementary to formal therapy sessions. convey our message that home-based, parent-delivered therapy comprising action observation and repeated practice does not We applaud the provision of open access summaries of research improve upper limb function more than repeated practice alone. findings in the Journal of Physiotherapy. On this occasion, key Instead, the title of the synopsis implies that parent-delivered aspects of the research have been misrepresented in the critical therapy does not lead to improved upper limb function in this appraisal and we request that this is addressed. group compared with repeated practice alone. It is not possible to make conclusions from our trial about the benefits of adding Acknowledgements: Funding: Dr Basu is funded through an parent-delivered therapy to repeated practice alone, as in our trial NIHR Career Development Fellowship. The views expressed in this both groups of children were receiving parent-delivered therapy. publication are those of the authors and not necessarily those of Furthermore, the synopsis title omits the word ‘unilateral’; we the NHS, the National Institute for Health Research, or the studied a specific group of children with unilateral cerebral palsy, Department of Health. not cerebral palsy in general. The comment regarding difference in adherence between the two groups does not acknowledge the fact Anna Purna Basua,b, Emma Victoria Kirkpatrickc and that the difference observed was not statistically significant. With Janice Pearsed reference to the comment that children with more severely affected hand function might not be able to perform the prescribed aInstitute of Neuroscience, Newcastle University, Newcastle upon Tyne tasks, we tailored activities to the interests and abilities of bDepartment of Paediatric Neurology, Newcastle upon Tyne Hospitals participants. NHS Foundation Trust, Newcastle In contrast to the suggestion from the published synopsis title, we cClinical Trials Unit, Southampton University, Southampton found that both parent-delivered home-based approaches that were dTherapy Services, Newcastle upon Tyne Hospitals NHS Foundation used led to small but significant improvements in hand function in children aged 3 to 10 years with unilateral cerebral palsy. These Trust, Newcastle upon Tyne, UK improvements were seen in all of the three outcome measures that were used. The very reason for embarking on this trial was our References awareness of a need to supplement therapist input with parent- delivered home-based approaches in an attempt to increase the 1. Shields N. J Physiother. 2016;62:224. overall therapy dose. We were successful in achieving this. Therefore, 2. Johnston LM. J Physiother. 2016;62:224. 3. Kirkpatrick E, et al. Dev Med Child Neurol. 2016;58:1049–1056. http://dx.doi.org/10.1016/j.jphys.2017.05.008 Reply to Basu et al We are happy to respond to the comments made in the above approaches used led to small but significant improvements in hand letter about the Journal of Physiotherapy’s appraisal1 of the trial by function in children aged 3 to 10 years with unilateral cerebral palsy’. Kirkpatrick et al.2 A misconception that underlies the authors’ comments is that The approach taken in the Critically Appraised Papers section of the within-group improvements observed in both groups in the the Journal of Physiotherapy for reporting results of randomised, trial should be interpreted as evidence that both interventions are controlled trials is to focus on between-group differences. As effective. In point of fact, analyses of within-group data against stated by the eminent statisticians, Bland and Altman: baseline, although often used, can be highly misleading.4 Inter- preting data in this way may be invalid because any improvement The essential feature of a randomised trial is the comparison could be due to something other than the interventions, such as between groups. Within group analyses do not address a becoming more familiar with the test procedures. The only way to meaningful question: the question is not whether there is a determine whether any improvement was due to the interventions change from baseline, but whether any change is greater in one is by using a third ‘no intervention’ group for comparison, which group than the other.3 this trial did not have. We stand by this approach. This makes it impossible to agree with The letter also indicates that the title of the synopsis was the authors’ claim that both ‘parent-delivered home-based misleading and lacked important details. Because of the amount of 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 144–153 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation [TD$NAMSE]RFITeddy]AMSRIF.$DT[EN D[NATME]ORU$S osterhuis.E[TD$]SMURNA a3,T6]F_D$I[ b, NAMRTS[ERID]F$ aymond WS.NTARDMEFI$][ NUM$DT[O]ESRA steloT[$SURNAME.]D a,b,c, A[TD]FSERINJM$ ohanna MDATENS.RI$F[]M Av]N$RUM[TDES an DongenTD]ES$[RNA.MU a,b, R$TISF[NAMED]Wilco CINAFE$TD]R[.SM S$RU]NET[MDPA eul]E.NTMD$SURA[ d,e, TNS[DME]MIFA$R ichiel RTRNIM[ES.DA$]F R[NTdD]A$SEMU e BoerTMURS$E[ADN]. a,b, RSTNAMIE]JDF$[ udith EE.MAN]SRIF$D[T SU$DTRN[BA]ME osmansU[T]ED.M$ARNS a,b, F$T[C]EMANDIRS armen LIR$ST[NAME.]FD E]URM$DTVN[SA leggeert-LankampDT[.$ES]URNAM d, ]AM$NT[EMSDRIF ark PMAFDNEIT$]S.[R $SURNAET]A[MD rts$NRDEMS.UT[A] eT$F[I_4],D6 $FI[DRSTNAME]Maurits WSRIE.T$D[MAFN] vMANRE]US$[TD an TulderER]AM.NU$DT[S a,b a Department of Health Sciences, Faculty of Earth and Life Sciences, VU University Amsterdam; b the EMGO+ Institute for Health and Care Research, Amsterdam; c Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam; d Department of Neurosurgery, Leiden University Medical Center, Leiden; e Department of Neurosurgery, Medical Center Haaglanden, The Hague, the Netherlands KEY WORDS ABSTRACT Rehabilitation Question: Is referral for early rehabilitation after lumbar disc surgery effective and cost-effective Exercise therapy compared to no referral? Design: Multicentre, randomised, controlled trial, and economic evaluation Intervertebral disc degeneration with concealed allocation and intention-to-treat-analysis. Participants: Adults who underwent Discectomy discectomy for a herniated lumbar disc, confirmed by magnetic resonance imaging, and signs of nerve root compression corresponding to the herniation level. Intervention: Early rehabilitation (exercise therapy) for 6 to 8 weeks, versus no referral, immediately after discharge. Outcome measures: In line with the recommended core outcome set, the co-primary outcomes were: functional status (Oswestry Disability Index); leg and back pain (numerical rating scale 0 to 10); global perceived recovery (7-point Likert scale); and general physical and mental health (SF12), assessed 3, 6, 9, 12 and 26 weeks after surgery. The outcomes for the economic evaluation were quality of life and costs, measured at 6, 12 and 26 weeks after surgery. Results: There were no clinically relevant or statistically significant overall mean differences between rehabilitation and control for any outcome adjusted for baseline characteristics: global perceived recovery (OR 1.0, 95% CI 0.6 to 1.7), functional status (MD 1.5, 95% CI –3.6 to 6.7), leg pain (MD 0.1, 95% CI –0.7 to 0.8), back pain (MD 0.3, 95% CI –0.3 to 0.9), physical health (MD –3.5, 95% CI –11.3 to 4.3), and mental health (MD –4.1, 95% CI –9.4 to 1.3). After 26 weeks, there were no significant differences in quality-adjusted life years (MD 0.01, 95% CI –0.02 to 0.04 points) and societal costs (MD –s527, 95% CI –2846 to D16[$ITF_] 506). The maximum probability for the intervention to be cost-effective was 0.75 at a willingness-to-pay of s32 000/quality-adjusted life year. Conclusion: Early rehabilitation after lumbar disc surgery was neither more effective nor more cost-effective than no referral. Trial registration: Netherlands Trial Register NTR3156. [Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017) Early rehabilitation after lumbar disc surgery is not effective ]I_6DF$[3Tor cost-effective compared to no referral: a randomised trial and economic evaluation. Journal of Physiotherapy 63: 144–153] © 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction despite a period of conservative management.6 Rates of spinal surgery differ across and within countries:7 in the United States Lumbosacral radicular syndrome, also called sciatica, is commonly caused by a herniated lumbar disc.165[]TDI$F_ The syndrome is they are 30% higher than in the Netherlands, 50 to 60% higher than characterised by lower limb pain radiating below the knee in an in Canada, and 80% higher than in the UK.2 It is estimated that in area of the leg served by one or more lumbosacral nerve roots. Sometimes, there are other neurological findings such as sensory the Netherlands, about 12 000 operations per year are performed and motor deficits. The incidence of sciatica is estimated at 5 per for herniated lumbar discs.4 Recovery rates after conventional 1000 adults in Western countries.2 In the Netherlands, the incidence of sciatica has increased from 75 000 to 85 000 cases microdiscectomy of 66% at 4 weeks, and 75% at 8 weeks follow-up per year over the past decade.3,4 The direct and indirect costs of have been reported,8 and return to work rates of 15% at 2 months patients suffering from sciatica approximate s1.2 billion per year.3 follow-up.9 A recently published systematic review concluded that The natural course of sciatica is favourable in the majority of patients;5 therefore, international consensus is that surgical even 5 years after surgery, patients still experience mild to treatment should only be offered if the radiating leg pain persists moderate levels of pain and disability.10 Two common options exist for postoperative management.11 The first option is referral for early rehabilitation immediately after discharge. The second option comprises the advice to return to an active lifestyle, with postoperative rehabilitation only for those http://dx.doi.org/10.1016/j.jphys.2017.05.016 1836-9553/© 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Research 145 patients whose symptoms persist longer than 6 to 8 weeks. A of bias due to this lack of blinding of participants. Participants were recent systematic review investigated the effectiveness of rehabil- recruited from 10 peripheral hospitals that were located in urban itation following lumbar disc surgery.12 For exercise programs or regional areas of three regions in the Netherlands. Primary care starting 4 to 6 weeks after surgery, there is moderate evidence that physiotherapists and exercise therapists in the catchment areas of they are more effective in improving physical function, and low- these hospitals provided the early rehabilitation following lumbar quality evidence that they are more effective than no treatment in disc surgery. decreasing pain. Moreover, there is moderate evidence that high- intensity exercises starting 4 to 6 weeks after surgery are more Intervention effective in improving physical function than low-intensity exercises, and low-quality evidence that they are more effective During hospitalisation (usually 1 to 2 days) all participants, in decreasing pain than low-intensity exercises. Large, high-quality regardless of treatment allocation, received usual postoperative studies assessing the effectiveness of immediate postoperative care. More specifically, during one or two sessions, a physiothera- interventions are lacking.12 The effectiveness of early rehabilitation pist or nurse provided advice and instructions for transfers (eg, bed has been assessed in three mono-centre studies, which included a to stand, chair to stand) and performing activities of daily living, in total of 124 patients.13–15 The first outcome measurement was at preparation for discharge. At discharge, participants received a 6 weeks, showing better function in the early rehabilitation booklet providing advice (mainly regarding activities of daily group,13–15 but no difference in pain.14,15 The next follow-up was at living) and suggestions for exercises, focusing on muscle strength- 12 weeks, showing better function but inconsistent results for ening, core stability and mobilisation. pain.13–15 As referral for rehabilitation is associated with higher healthcare costs than no referral, it is important to assess its cost- Experimental group: referral for early rehabilitation effectiveness as well. However, cost-effectiveness studies on early Participants in the experimental group received a referral for rehabilitation are lacking. postoperative exercise therapy in primary care starting the first Therefore, the research question for this multicentre, random- week after discharge. Over 6 to 8 weeks, participants received one or ised, controlled trial was: two individual, face-to-face, exercise therapy sessions of 30 minutes per week, conforming to a standardised treatment protocol based on Is referral for early rehabilitation after lumbar disc surgery a national clinical guideline.17 The 6- to 8-week period reflected the effective and cost-effective compared to no referral? period before patients consulted their neurosurgeon again after surgery. The timing of this follow-up consultation and, therefore, the Method exact duration of the period until follow-up depended on the organisation in the hospital in which the participant was treated. The Design treatment protocol described the treatment in terms of treatment goals; the main goal of the exercise therapy was to gradually extend A multicentre, randomised, controlled trial was conducted with activities of daily living from personal care to housekeeping tasks in a 26-week follow-up period and repeated measurements within the short term, and return to work and prepare for sports and leisure the first 12 weeks. This schedule of measurements was chosen activities in the long term. In the first week, therapists performed because a change in outcomes was expected predominantly during physical examinations, and focused treatment on the ability and and shortly after the first 6 postoperative weeks. Details of the possibility to execute personal care activities and perform transfers design and methods of the trial have been published previously.16 in the home situation. From the second week onwards, exercises were taught with gradually increasing intensity, targeting limita- Participants, therapists and centres tions that were found in the initial postoperative assessment. The exact type of exercises was left to the therapists’ discretion, based on Eligible patients had a herniated lumbar disc confirmed by the outcomes of the physical examination and taking participants’ magnetic resonance imaging (MRI) and signs of nerve root preferences into account, which was in line with routine clinical compression corresponding to the level of disc herniation; were practice. Therapists provided tailored advice on lifestyle and the aged between 18 and 70 years; and were able to fill out execution of activities of daily living. Treatment could be terminated questionnaires in Dutch themselves. Neurosurgeons referred before the end of the 6- to 8-week period if the participant was fully potentially eligible patients to the research team. Research nurses recovered. At each treatment session, participating therapists filled checked the eligibility criteria and excluded patients if they met out a registration form, including (amongst other information): any of the following criteria: cauda equina syndrome, neurogenic treatment goals on both a global and more specific level; whether a claudication, co-morbidities of the lumbar spine (eg, fractures, home exercise regimen was prescribed or not; and, if applicable, the carcinomas, osteoporosis), spinal surgery in the prior 12 months, reason for terminating the treatment. contraindications to exercise therapy (eg, acute respiratory or cardiovascular complaints, acute systemic infections), pregnancy, Control group: no referral for early rehabilitation or previous lumbar disc surgery at the same level and on the same Participants assigned to the control group were not referred for side. To conceal treatment allocation, a computer-randomised list was generated for each hospital by an independent investigator rehabilitation after discharge from the hospital. Participants could prior to study commencement. To achieve the predetermined consult their neurosurgeon or general practitioner in case of sample size for the experimental and control groups, weighted recurring or increasing complaints, but they were requested to block randomisation (blocks of four) was used. Based on these lists refrain from referral for exercise therapy or other allied health and prior to the start of the study, the independent investigator interventions in the 6- to 8-week period before consulting the prepared a set of numbered, opaque and sealed envelopes neurosurgeon after surgery. The research nurses limited the extent containing the assigned postoperative strategy for each hospital. to which they provided advice when participants allocated to the Directly after having received the completed baseline question- control group called them. To prevent diminishing contrast naire and prior to surgery, the research nurse opened the next between groups, only advice that had been given during the consecutive envelope in order to inform the participant about the clinical phase was repeated. assigned postoperative strategy. The nature of the postoperative strategies and the use of patient-reported outcome measures Follow-up neurosurgeon consultation precluded blinding of the participants and the therapists. Six to 8 weeks after discharge, a follow-up consultation with the Participant expectations were measured to assess a possible risk neurosurgeon took place, which was in line with routine clinical practice (see above). Whether participants in the experimental group continued rehabilitation or control group participants started
146 Oosterhuis et al: Rehabilitation after lumbar disc surgery rehabilitation after this follow-up consultation was left to the from unpaid work (ie, all hours of volunteer work, and domestic neurosurgeons’ discretion. This continuation of rehabilitation as well and educational activities that participants were not able to as all other healthcare consumption (in both groups) was measured perform due to their leg and back pain) were valued using a Dutch by cost questionnaires. Compliance with the allocated treatment shadow price.32 Appendix 1 presents an overview of the cost prices and possible crossover were measured with questionnaires. used for valuing resource use (see eAddenda). All costs were converted to 2014 euros using consumer price indices.33 Because of Outcome measures the 26-week time horizon, discounting of costs was not necessary. Utilities based on the EuroQol (EQ-5D-3L) were estimated using Baseline assessments took place preoperatively, and follow-up the Dutch tariff.28 Quality-adjusted life years (QALYs) were measurements at 3 days (pain intensity only) and at 3, 6, 9, 12 and calculated using linear interpolation between measurement 26 weeks after surgery. The study used standardised instruments points. Details of the statistical analysis plan available in Appendix with demonstrated validity, reliability and responsiveness, as 2 and the code used to conduct the analyses in the statistical detailed below. Outcomes were measured centrally using online software are presented in Appendix 3 (see eAddenda). questionnaires, but postal questionnaires were available if requested. The baseline measures included demographic data Data analysis (such as age, gender and education), relevant prognostic factors and primary outcomes. Sample size calculations were based on a Cochrane review assessing the effectiveness of rehabilitation following lumbar disc Prognostic factors surgery,34 and were performed for the three main outcomes (for Prognostic factors, indicating an unfavourable outcome after all: power 0.9, alpha 0.05, two-tailed test). To detect clinically relevant mean differences in a multi-level analysis, the following lumbar disc surgery, included duration of symptoms and medica- numbers of participants were needed: 165 participants for an 8- tion use preceding surgery, and complications during surgery, point difference on the Oswestry Disability Index, 105 participants which were measured at baseline.18 Also at baseline, scores were for a 2-point difference on the NRS, 150 participants for a 20% obtained on the following instruments: credibility/expectancy difference on the dichotomised Global Perceived Effect Scale. questionnaire,19 the Örebro Musculoskeletal Pain Screening Anticipating 15% potential study withdrawal, 200 participants Questionnaire,20 the Fear-Avoidance Beliefs Questionnaire,21 and were needed, with an unequal number per group (109 experimen- the Pain Coping Inventory.22 tal versus 91 control) taking into account the multilevel structure of the data in the experimental group. Analyses of effectiveness Co-primary outcomes and cost-effectiveness were performed using STATAa. Following the recommended core set of outcomes for low back Analyses of effectiveness pain research,23 all (self-reported) outcomes were selected based Baseline characteristics in both groups were compared to check on the rationale and the main aims of the exercise therapy. Functional status was assessed by the Oswestry Disability Index prognostic comparability. The primary analysis was an intention- (version 2.1.a).24 Average pain intensity over the preceding week to-treat analysis. All continuous outcomes were analysed in a was measured for leg pain and low back pain on an 11-point linear mixed model with responses at baseline, 3, 6, 9, 12 and numerical rating scale (0 = no pain to 10 = worst imaginable 26 weeks. In these analyses, the levels of hospital, therapist, pain).25 Global perceived effect was evaluated using the seven- participant, and time of measurement were taken into account. Log point Global Perceived Effect scale, ranging from ‘completely likelihood ratios of naïve models were compared with models recovered’ to ‘worse than ever’. This was dichotomised into success including an intercept for hospital or therapist. Time-by-treatment (completely and much recovered) and non-success (slightly interactions were tested. Overall mean differences were presented recovered, no change, slightly worse, much worse and worse than or mean differences per time point in the case of significant time- ever). General physical and mental health were assessed with the by-treatment interactions. Regression coefficients with 95% CI Medical Outcome Study Short Form 12 (SF-12).26 For the cost- signifying differences between baseline and follow-up measure- effectiveness analysis, the EuroQol (EQ-5D-3L) was administered ments were estimated. Analyses were adjusted for confounders, to assess health-related quality of life.27,28 This instrument defined as variables that changed the regression coefficient by evaluates five health dimensions on a three-point scale (no 10%. For the dichotomous outcomes, a generalised mixed model problems, moderate problems, and severe problems). (logit link) with the same multilevel structure was used. Odds ratios with 95% CI were calculated. A per-protocol analysis was Cost measures and utility scores performed to estimate the extent to which protocol deviations Cost data were collected from a societal perspective at 6, 12 and influenced the results. A protocol deviation was defined as receiving one or more sessions of exercise therapy in the first 26 weeks after surgery using cost questionnaires. All costs related 6 to 8 weeks after surgery in the control group, or not receiving any to leg and back pain were considered. These included intervention, sessions of exercise therapy in the first 6 to 8 weeks after surgery healthcare, informal care, absenteeism, and unpaid productivity by participants in the experimental group. costs. Intervention costs were estimated based on the total number of physiotherapy and/or exercise therapy sessions the participant Analyses of cost-effectiveness received during the period to the first follow-up (ie, 6 weeks). A cost-utility analysis was performed according to intention-to- Healthcare costs included primary and secondary healthcare costs valued using Dutch standard costs.297$TD_F[I6] If unavailable, prices treat from a societal perspective. Using multivariate imputation by according to professional organisations were used. Both prescribed chained equations (MICE) with predictive mean matching, and over-the-counter medication use was valued using unit prices 10 complete data sets were created (loss-of-efficiency <5%).35 of the Royal Dutch Society of Pharmacy.30 Informal care was valued The imputation model consisted of variables differing between using a Dutch shadow price of s13.74/hour.29 A modified version of groups at baseline and between respondents with and without the Productivity and Disease Questionnaire was used to measure complete follow-up, and variables associated with the outcomes. absence from paid work.31 Absenteeism costs were valued Analyses were performed on all 10 separate complete datasets and according to the friction cost approach,32 using the estimated pooled estimates were estimated according to Rubin’s rules.35 price of productivity losses per sickness absence day in the Mean between-group cost differences were calculated for total and Netherlands based on 5-year age categories and gender.29 The disaggregated costs. Seemingly unrelated regression analyses were friction cost approach assumes that costs are limited to the period performed to estimate total cost and QALY differences while needed to replace a sick worker (ie, the friction period, which is adjusting for confounders and taking into account the possible estimated to be 23 weeks in the Netherlands).32 Productivity losses
Research 147 correlation between costs and effects. Incremental cost-effective- Results ness ratios were calculated by dividing the adjusted difference in total costs by the adjusted difference in QALYs. Bias-corrected and Flow of participants, therapists and centres through the study accelerated bootstrapping with 5000 replications was used to estimate the uncertainty surrounding the cost differences and From May 2012 to December 2014, 356 patients were referred incremental cost-effectiveness ratios. The latter was graphically to the research team and, of those, 172 were not included for presented in a cost-effectiveness plane.36 A cost-effectiveness various reasons (Figure 1). Of the remaining 184 participants, acceptability curve was estimated to indicate the intervention’s 10 recovered before surgery could be performed and one probability of cost-effectiveness compared with control at differ- participant did not undergo surgery because immediate angio- ent values of willingness-to-pay.37 Three sensitivity analyses were plasty was required for an acute vascular complication unrelated to performed: a complete-case analysis; estimation of QALYs using the disc herniation. Of the 173 participants who underwent the SF-12 and the tariff of Brazier et al;38 and a per-protocol surgery, four were excluded due to cauda equina syndrome (n = 2), analysis. carcinoma (n = 1), and decompression for stenosis (n = 1). [(Figure_1)TD$IG] Figure 1. Design and flow of participants through the trialDI.[F]$T_65 PT = physiotherapist. a Two participants had missing measurements at this time point but were not lost to follow-up.
148 Oosterhuis et al: Rehabilitation after lumbar disc surgery Is referral for early rehabilitation after lumbar disc surgery (72%), strength (66%), endurance (54%), and instructions regarding (experimental) effective and cost-effective compared to no lifestyle and posture (45%). Therapists prescribed home exercises referral (control)? in 91% of the sessions. For 41% of the participants, treatment was ended at 6 to 8 weeks after surgery because treatment goals were Baseline characteristics of the experimental (n = 92) and reached. At the 6-week follow-up, participants in the experimental control (n = 77) group are presented in Table 1. Baseline measures group reported having received on average 6.5 treatment sessions were taken a mean of 13 days (SD 15) before surgery. The groups (SD 3.7). were well matched with respect to demographic characteristics and baseline values of the outcome measures. Complete data were Co-interventions during the first 6 weeks were limited, did not available from 88% and 87% of the participants in rehabilitation and greatly differ between the groups and included (experimental control group on the effect measures, and from 80% and 74% on the versus control): visit to an occupational physician 35% versus 31%, cost measures, respectively. visit to a general practitioner 21% versus 17%, > 1 visit to a neurosurgeon 9% versus 4%, other allied health professional 3% For 51 participants (55%) in the rehabilitation group, registra- versus 1%, and complementary/alternative health professional 1% tion forms were obtained from the treating therapists. The versus 4%. Healthcare utilisation during the 26 weeks of follow-up reported aims of the treatment were primarily focused on included (experimental versus control): radiograph 2% versus 4%, stabilisation and coordination (73% of the sessions), mobility MRI 8% versus 7%, revision surgery 3% versus 5%, physiotherapy or exercise therapy after 6 weeks 57% versus 31%. Table 1 Baseline characteristics of the participants. In the intention-to-treat analysis, log likelihood ratios of naïve models and models including an intercept for hospital were equal. Characteristic Exp Con Furthermore, five therapists treated two participants each and all (n = 92) (n = 77) other therapists treated one participant each. Hospital and therapist were, therefore, not included as a level in the mixed Age (yr), mean (SD) 47 (12) 47 (12) model analyses. Interaction terms for time by treatment were not Female, n (%) 54 (59) 44 (57) significant, and therefore not included. Multilevel analyses showed Living alone, n (%) 16 (16) 8 (10) no clinically relevant or statistically significant overall mean Education, n (%) differences between groups on any outcome (Table 2). Individual 20 (22) 17 (22) participant data are presented in Appendix 4 (see eAddenda). low 47 (51) 35 (45) Recovery rates for the rehabilitation and control group, respec- middle 25 (27) 25 (32) tively, were 59% and 57% at 3 weeks, 70% and 69% at 6 weeks and high 74 (80) 57 (74) then plateaued, except for a temporarily increased recovery at Employed, n (%) 12 weeks in the control group. A similar pattern of early decrease in Level of herniation, n (%) 1 (1) 2 (3) pain and increase in functional status was seen in both groups. L2 to 3 10 (11) 4 (5) L3 to 4 31 (34) 42 (58) In the experimental group, six participants (7%) did not receive L4 to 5 48 (52) 29 (38) any treatment by a physiotherapist or exercise therapist. Seven L5 to S1 2 (3) participants (9%) in the control group received physiotherapy L5 to 6 1 (1) during the first 6 weeks after surgery. Therefore, the per-protocol Type of herniation, n (%) 34 (44) analysis included 156 participants. Baseline characteristics were sequestered 34 (37) 46 (60) largely similar to the intention-to-treat analysis, and multilevel bulging disc 57 (62) analyses showed no relevant or statistically significant differences extraforaminal 2 (3) between groups on any outcome (data not shown). Functional status (ODI, 0 to 100), mean (SD) 1 (1) 50.4 (15.6) Pain intensity (NRS, 0 to 10), mean (SD) 48.6 (17.3) The between-group difference in QALYs was not significant. leg 7.7 (1.8) Total societal costs in the rehabilitation group were lower than in back 7.8 (1.9) 6.1 (2.6) the control group, but this difference was not statistically General physical health (SF12, 0 to 100), mean (SD) 6.5 (2.5) 26.7 (15.4) significant (–s527, 95% CI –2846 to 1506) (Table 3). Disaggregate General mental health (SF12, 0 to 100), mean (SD) 26.2 (16.1) 50.3 (21.8) costs that were significantly higher in the rehabilitation group than Psychosocial status (ÖMPSQ, 0 to 210), mean (SD) 51.6 (21.5) 114.2 (20.5) in the control group included intervention costs (s257, 95% CI Fear avoidance beliefs (FABQ, 0 to 24), mean (SD) 109.0 (24.9) 226 to 295) and primary care costs (s364, 95% CI 71 to 630). The physical activity 15.4 (5.4) control group had higher costs for informal care (–s602, 95% CI work 16.1 (4.4) 18.5 (11.3) –1582 to –172) and unpaid productivity (–s449, 95% CI –1005 to Expectations: (CEQ, 3 to 27), mean (SD) 16.8 (11.0) –132). Absenteeism costs were the largest contributor to total expectancy surgery 22.9 (3.0) societal costs in both groups, but did not differ significantly credibility surgery 23.2 (2.8) 21.7 (3.7) between the groups. The incremental cost-effectiveness ratio was Expectations: credibility item (CEQ, 1 to 9), mean (SD) 22.0 (3.2) –85 394, indicating that the intervention saved s85 394 per QALY experimental 6.3 (1.8) gained (Table 4). The cost-effectiveness pairs were scattered control 6.5 (1.8) 6.5 (1.4) around the four quadrants of the cost-effectiveness plane, Pain coping: active (PCI) 6.4 (1.6) indicating a high level of uncertainty around the estimates active 6.5 (1.3) (Figure 2a). The cost-effectiveness acceptability curve indicated passive 6.7 (1.3) 6.5 (1.2) that if society was not willing to pay anything per QALY gained, the Duration of complaints (months), n (%) 6.5 (1.3) probability of cost-effectiveness was 0.73 (Figure 2b). This 0 to 1 0 (0) probability only marginally increased to a maximum of 0.75, at 1 to 2 2 (2) 3 (4) a willingness to pay of s32 000/QALY. The results of the three 2 to 3 6 (7) 7 (9) sensitivity analyses did not substantially differ from the main 3 to 6 1 (1) 29 (38) analysis (Table 4). 6 to 9 35 (38) 13 (17) 9 to 12 18 (20) 7 (9) Discussion >12 6 (7) 18 (23) Medication use, n (%) 24 (26) Early rehabilitation after lumbar disc surgery had no significant every day 47 (61) effect on any clinical outcome, QALYs or societal costs in not every day 56 (61) 14 (18) comparison with no referral for early rehabilitation. In both no 18 (20) 16 (21) Surgical complications, n (%) 18 (20) nerve root injury 1 (1) dural tear 1 (1) 2 (3) increase in sensimotor deficit 2 (2) 1 (1) 0 (0) Percentages may not tally to 100%, due to rounding. CEQ = credibility/expectancy questionnaire, FABQ = Fear-Avoidance Beliefs Ques- tionnaire, NRS = numerical rating scale, ODI = Oswestry Disability Index, ÖMPSQ = Örebro Musculoskeletal Pain Screening Questionnaire, PCI = Pain Coping Inventory, SF12 = Medical Outcome Study Short Form 12.
Research 149 Table 2 Clinical outcomes. Outcome Exp Con Mean difference (n = 92) (n = 77) (95% CI) Functional status (ODI, 0 to 100) 48.6 (17.3) 50.4 (15.6) crude 1.0 (–3.7 to 5.7) baseline 29.5 (18.9) 29.6 (19.0) adjusted 1.5 (–3.6 to 6.7)aTD$[_7]IF5 3 weeks 20.3 (16.2) 18.9 (16.9) 6 weeks 16.6 (16.9) 15.2 (17.1) crude –0.1 (–0.8 to 0.6) 9 weeks 15.4 (15.6) 13.5 (17.0) adjusted 0.1 (–0.7 to 0.8)b 12 weeks 14.3 (16.6) 14.3 (18.0) 26 weeks crude 6$0_DF]0IT[ .3 (–0.3 to 0.9) 7.8 (1.9) 7.7 (1.8) adjusted 0.3 (–0.3 to 0.9)c5[]FID$T_8 Pain intensity leg (NRS, 0 to 10) 2.7 (2.9) 3.1 (3.0) baseline 2.1 (2.5) 2.1 (2.5) OR 1.0 (0.6 to 1.7) 3 weeks 1.8 (2.5) 2.1 (2.7) 6 weeks 2.0 (2.7) 1.8 (2.6) crude –1.1 (–8.5 to 6.3) 9 weeks 2.0 (2.7) 2.0 (2.7) adjusted –3.5 (–11.3 to 4.3)d 12 weeks 26 weeks 6.5 (2.5) 6.1 (2.6) crude –0.9 (–6.8 to 5.0) 3.5 (2.4) 3.3 (2.4) adjusted –4.1 (–9.4 to 1.3)e Pain intensity back (NRS, 0 to 10) 2.8 (2.1) 2.8 (2.3) baseline 2.8 (2.5) 2.2 (2.4) 3 weeks 2.9 (2.5) 2.4 (2.5) 6 weeks 9_D52$[IFT] .8 (2.4) 2.5 (2.6) 9 weeks 12 weeks 54 (59) 44 (57) 26 weeks 64 (70) 53 (69) 61 (66) 53 (69) Global perceived effect, n (%) recovered 62 (67) 60 (78) 3 weeks 60 (65) 50 (65) 6 weeks 9 weeks 26.2 (16.1) 26.7 (15.4) 12 weeks 38.2 (22.3) 36.5 (23.7) 26 weeks 47.9 (26.3) 48.7 (26.2) 53.5 (29.6) 54.3 (31.0) General physical health (SF12, 0 to 100) 57.8 (30.2) 62.2 (33.4) baseline 63.0 (31.8) 63.0 (34.5) 3 weeks 6 weeks 51.6 (21.5) 50.3 (21.8) 9 weeks 58.1 (21.7) 61.2 (22.6) 12 weeks 70.0 (21.8) 71.7 (22.1) 26 weeks 73.9 (20.2) 73.1 (23.5) 77.4 (21.0) 78.5 (23.3) General mental health (SF12, 0 to 100) 77.6 (20.8) 76.1 (23.0) baseline 3 weeks 6 weeks 9 weeks 12 weeks 26 weeks Data are mean (SD) unless stated otherwise. NRS = numerical rating scale, ODI = Oswestry Disability Index, SF12 = Medical Outcome Study Short Form 12. a Adjusted for functional status at baseline, age, gender, employment, back pain, general mental health, psychosocial profile, fear avoidance, expectancy and credibility surgery, credibility rehabilitation. b Adjusted for leg pain at baseline, living status, employment, psychosocial profile, general mental health, fear avoidance, expectancy and credibility surgery. c Adjusted for back pain at baseline, psychosocial profile, fear avoidanceD$26T,IF[_] expectancy surgery. d Adjusted for general physical health at baseline, age, living status, functional status, back pain, general mental health, psychosocial profile, fear avoidance, expectancy surgery, credibility rehabilitation and watchful waiting, pain coping. e Adjusted for general mental health at baseline, age, living status, employment, functional status, back pain, general physical health, psychosocial profile, fear avoidance, credibility and expectancy surgery, credibility rehabilitation and watchful waiting, pain coping. groups, the main decrease in pain and increase in functional status world situation and prospective collection of outcome data scores were obtained in the first weeks after surgery. The highest including cost data. Ten hospitals and many therapists were probability of the intervention being cost-effective compared with involved, which enhances the generalisability of the findings. control was 0.75, at a willingness-to-pay of s 32 000/QALY. The Using randomisation, measurement instruments recommended in results of the sensitivity analyses were in line with the main the core outcome set, and the low dropout rate guaranteed the analysis, indicating that the findings were robust. Based on these internal validity. Still, this study also had a few limitations. First, findings, early rehabilitation after lumbar disc surgery cannot be due to the nature of the intervention, participants and care considered effective or cost-effective in comparison with no providers could not be blinded. However, participant expectations referral. (ie, credibility scores for both experimental and control) were similar in both groups. Therefore, a lack of blinding does not seem The pragmatic randomised, controlled trial design was an im- to have had much impact on the results. Second, baseline measures portant strength of the present study, as it allowed for evaluation of and randomisation took place before surgery for logistic reasons the intervention’s effectiveness and cost-effectiveness in a real
150 Oosterhuis et al: Rehabilitation after lumbar disc surgery Table 3 Mean cost per participant in the experimental and control group, and mean cost differences between groups during the 26 weeks of follow-up. Cost category Cost per participant, (s) Cost difference, (s) mean (SEM) mean (95% CI) Exp Con crude adjusted (n = 92) (n = 77) Intervention costs 257 (16) 0 (0) 257 (228 to 290) 257 (226 to 295) Medical costs 1240 (117) 997 (192) 243 (–217 to 639) 241 (–205 to 688) 1046 (96) 652 (131) p][F5DI0_T$ rimary care 308 (117) 394 (77 to 677) 364 (71 to 630) s_F1D5]$I[T econdary care 172 (67) –136 (–454 to 92) –108 (–402 to 143) $DT_m5][2IF edication 22 (8) 37 (13) Informal care costs 987 (334) –15 (–48 to 10) –15 (–48 to 9) Absenteeism costs 375 (74) 4113 (718) –611 (–1817 to –165) –602 (–1582 to –172) Unpaid productivity costs 4404 (559) 693 (211) 291 (–1629 to 1967) Total 6790 (957) –484 (–1108 to –157) 27 (–1707 to 1591) 209 (67) –304 (–2812 to 1765) –449 (–1005 to –132) 6486 (626) –527 (–2846 to 1506) Table 4 Differences in pooled mean costs and effects (95% CI), incremental cost-effectiveness ratios, and the distribution of incremental cost-effect pairs around the quadrants of the cost-effectiveness planes. Analysis n Difference in costs (s) Difference in QALYs ICER Distribution CE-plane (%) Exp Con (95% CI) (95% CI) (s/point) NEaDT1]_[F6I$ SEb SWc NWd Maine 92 77 –678 0.01 –85394 13.2 55.3 17.7 13.8 (–3048 to 1357) (–0.02 to 0.04) Sensitivity 74 57 1458267 9.8 23.9 39.9 26.3 1f[_3ITDF$]5 92 77 –515 –0.00 –625531 22.7 40.0 32.5 4.8 86 70 (–3396 to 1749) (–0.03 to 0.03) –34438 22.7 50.0 10.7 16.6 ]2FID$T_[45 g –637 0.001 3hF]ID$T_5[ (–3002 to 1381) (–0.006 to 0.008) –329 0.01 (–2760 to 1738) (–0.02 to 0.04) CE = cost-effectiveness, ICER = incremental cost-effectiveness ratio, QALYs = quality-adjusted life years, which are measured on a scale from 0 to 1. a Refers to the northeast quadrant of the CE-plane, indicating that early rehabilitation is more effective and more costly than no referral for early rehabilitation. b Refers to the southeast quadrant of the CE-plane, indicating that early rehabilitation is more effective and less costly than no referral for early rehabilitation. c Refers to the southwest quadrant of the CE-plane, indicating that early rehabilitation is less effective and less costly than no referral for early rehabilitation. d Refers to the northwest quadrant of the CE-plane, indicating that early rehabilitation is less effective and more costly than no referral for early rehabilitation. e Main analysis using imputed dataset. f Sensitivity analysis 1 was a complete case analysis. g Sensitivity analysis 2 involved estimation of QALYs using the SF-12 questionnaire25 and the tariff of Brazier et al.37 h Sensitivity analysis 3 was a per-protocol analysis. (ie, treatment started a few days after surgery) and to prevent consistency strengthened the conclusion that was drawn based participants’ uncertainty during and after hospitalisation about the postoperative management. Eleven participants did eventually not on the study results. receive surgery and were, therefore, withdrawn. Besides, as Fergusson et al suggested, excluding these prematurely random- The rationale for the intervention in the current study was that ised participants does not bias the analysis if treatment allocation is not associated with the likelihood of undergoing surgery.39[D]86TI_F$ early rehabilitation aimed at resumption of daily activities Participants in both arms declined surgery (control n = 3, experimental = 7) due to recovery. There is no reason to assume prescribed to all patients might accelerate recovery, including that recovery before surgery could be performed is associated with group allocation. Third, the study relied on self-reported cost data. return to work. However, this was not found in the current trial. Health insurance claim data and sickness absence data are practically inaccessible in the Netherlands, as it requires the The predominantly early decrease in pain and increase in cooperation of over 30 different insurance companies and employers of all employed participants. Moreover, data for functional status without relevant between-group differences informal and uninsured care are not registered at all by these companies. However, closed questions were used to measure costs was also reported in earlier trials that compared rehabilitation over periods of 1.5 to 3 months. As closed questions have been with no treatment starting 1 week,15]$TID_9F[6 or 6 weeks after surgery.41 The found to be reliable for recall periods up to 6 months,40 it was not present results strengthen the conclusion of the Cochrane review expected that recall bias would be an important issue. Besides, of rehabilitation after lumbar disc surgery,12 which found very any recall bias (for absenteeism or healthcare costs) was likely to have affected both groups equally. Finally, a potential limitation of limited evidence of no difference between rehabilitation programs the study was that multiple co-primary outcomes were nomi- nated, which might have inflated the risk of a Type-I error. On the starting immediately after surgery and no rehabilitation, because other hand, all these a 9p]F[6_ID$T riori selected outcome domains are included in the recommended core set for low back pain trials,23 only one low-quality, randomised, controlled trial was available as all of them are considered to be important. Moreover, it is (ie, the trial by Ju et al42). Another recently published review that believed that a trial has to be interpreted in light of all the available evidence, based on the apriori selected co-primary focused on the effectiveness of physical therapy starting within the outcomes. Furthermore, in the present study, no statistically significant effects were identified on any of these outcomes. This first 4 weeks after surgery concluded that early physiotherapy leads to a moderate, statistically significant reduction in pain compared to the control group.43 Methodological differences (eg, the Cochrane review12 only included randomised, controlled trials while Snowdon43 also included controlled clinical trials), differ- ences in interpretation regarding the starting point of treatment, and differences in the interpretation of the content of the control group may explain these differences. Snowdon et al,43 for example, argued that the randomised, controlled trial of Erdogmus et al44 could also be included (in addition to the aforementioned trial of Ju et al42) in the comparison ‘treatment starting immediately after surgery versus no treatment’ of the Cochrane review. If this was done, and the present study was also included, three randomised, controlled trials could be included in a meta-analysis for this
)]Ge_ugITF$rD2i([ Research 151 Figure 2. Cost-effectiveness planes indicating the distribution of incremental cost-effect pairs around its four quadrants (A) and cost-effectiveness acceptability curves indicating the probability of early rehabilitation being cost-effective in comparison with no referral for early rehabilitation for different values (s) of willingness-to-pay per QALY (B). comparison (ie, Ju et al,42 Erdogmus et al44 and the present study). intervention under study might have been too generic. Based on The pooled SMD (random effects model) would be –0.34 (95% CI the registration forms, the content of the treatment seemed to –1.04 to 0.36). In sum, it is believed that the evidence illustrates deviate from the protocol, with a focus on isolated exercises rather that early rehabilitation has no added value in comparison to no than the resumption of activities of daily living. As a consequence, treatment. the intervention under study might have been too generic instead of specifically focusing on the activities of daily living needs of the One potential explanation for the findings of this study is that individual participant, and this may have influenced its effective- the combination of careful selection of patients who may benefit ness. Although 50% of the registration forms were received, it is from surgery by the spinal surgeon and the predominantly thought that this description of the intervention under study is minimal invasive procedures (ie, microsurgery) led to a situation rather representative, as the main reason for not returning the in which the participants, in general, were only mildly affected in registration Tf_F[9ID4$] orms by the therapists was practical (eg, no time in the immediate postoperative period and, consequently, patients busy daily practice). On the other hand, as insight into the were able to resume their daily activities rather quickly. Another mechanisms of recovery is limited, the use of a more specific explanation may be that, although the current trial aimed to program targeting these mechanisms is hampered. It is unclear investigate an early rehabilitation program with a strong focus on which subgroups, if any, may benefit most from postoperative the activities of daily living needs of the individual participant, the
152 Oosterhuis et al: Rehabilitation after lumbar disc surgery rehabilitation. Further research may contribute to the clarification (NL35897.029.11) in September 2011. Subsequently, local review of mechanisms of recovery and identifying subgroups, and subsequently designing potentially effective interventions for boards of all participating hospitals approved the protocol. All those with residual complaints, which could then be tested in participants gave written informed consent before data collection further trials. An interesting finding in that respect is that interventions more specifically targeting mechanisms of pain began. chronification may be more effective, as persistent post-surgical Competing interests: Nil. pain may be associated with central changes in pain processing, and related to comorbid chronic pain.457[]F_$T0DI Pain education prior to Source of support: The Netherlands Organisation for Health lumbar disc surgery led to far less utilisation of healthcare.46 There Research and Development (ZonMw171102010). were no clinically relevant differences in pain and function compared to usual preoperative care. Further research could focus Acknowledgements: We thank the patients that participated in on combining preoperative pain education with postoperative this trial, the neurosurgeons involved, the other hospital staff rehabilitation for those with persisting pain at 6 to 8 weeks only. This potentially optimises outcomes after lumbar disc surgery and involved, and the primary care physiotherapists and exercise reduces healthcare utilisation. therapists. The only other cost-effectiveness study,47 alongside a trial Provenance: Not invited. Peer reviewed. comparing postoperative rehabilitation to no treatment,41 did not Correspondence: Prof Dr Raymond Ostelo, Department of find significant differences in costs and effects either. However, the intervention in that study started 8 weeks after surgery. The cost- Health Sciences, Faculty of Earth and Life Sciences, VU University effectiveness acceptability curve of that study showed that the Amsterdam, the Netherlands. Email: [email protected] probability of cost-effectiveness increased with an increasing willingness-to-pay to approximately 0.52 at a ceiling ratio of £50 References 000/QALY (approximately s60 000),47 which is lower than in the present study. The study included both patients with lumbar disc 1. Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. herniation and patients with stenosis, and reported that inpatient 2007;334(7607):1313–1317. nights were the largest contributor to total costs. Morris et al47 did not assess work absenteeism, whereas this was the main cost 2. Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of driver in the present study. The present results confirmed findings back surgery rates. Spine. 1994;19:1201–1206. of an earlier Dutch trial on rehabilitation after discectomy, which found absenteeism to be the largest contributor to total costs.48 To 3. Health Council of the Netherlands. Management of Lumbosacral Radicular Syndrome reduce these high costs, it is of utmost importance to develop (sciatica). The Hague: Health Council of the Netherlands; 1999. interventions that effectively speed up return to work after surgery. A rehabilitation-oriented approach in insurance medicine 4. van Beek E, Lemmens K, van Schooten G, Vlieger EJ. Reduceren van praktijkvariatie: effectively increased return-to-work rates compared to usual care budgettaire effecten van scherpere indicatiestelling. Breukelen: Plexus; 2010. insurance medicine in patients who underwent lumbar disc surgery.49 In this intervention, starting 6 weeks postsurgery, a 5. Vroomen PC, de Krom MC, Wilmink JT, Kester AD, Knottnerus JA. Lack of effective- medical adviser coordinated a multidisciplinary approach, includ- ness of bed rest for sciatica. N Engl J Med. 1999;340:418–423. ing all relevant healthcare providers, to achieve early return to work. Future research might, therefore, focus on investigating the 6. Andersson GB, Brown MD, Dvorak J, Herzog RJ, Kambin P, Malter A, et al. Consensus cost-effectiveness of similar multidisciplinary interventions that summary of the diagnosis and treatment of lumbar disc herniation. Spine. 1996; specifically aim at an early return to work. 21(Suppl):75S–78S. In conclusion, rehabilitation after lumbar disc surgery starting 7. Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States’ trends and immediately after hospital discharge was neither effective nor regional variations in lumbar spine surgery: 1992–2003. Spine. 2006;31:2707– cost-effective, compared to no referral for early rehabilitation. 2714. Participants in both groups improved more or less equally after surgery and early rehabilitation had no additional effect on pain, 8. Arts MP, Brand R, van den Akker ME, Koes BW, Bartels RH, Bartels RH, Leiden-The functional status, global perceived effect scale, general physical or Hague Spine Intervention Prognostic Study Group (SIPS). Tubular diskectomy vs mental health, or costs. conventional microdiskectomy for sciatica: a randomised controlled trial. JAMA. 2009;302:149–158. What is already known on this topic: The natural course of sciatica is favourable in the majority of patients, so surgery is 9. Rasmussen S, Krum-Møller DS, Lauridsen LR, Jensen SE, Mandøe H, Gerlif C, et al. only offered if the radiating leg pain persists despite a period of Epidural steroid following discectomy for herniated lumbar disc reduces neuro- conservative management. logical impairment and enhances recovery: a randomised study with two-year What this study adds: In this study, usual postoperative care follow-up. Spine. 2008;33:2028–2033. involved a physiotherapist or nurse providing instructions for transfers (eg, bed to stand), advice about performing activities 10. Machado GC, Witzleb AJ, Fritsch C, Maher CG, Ferreira PH, Ferreira ML. of daily living, and a booklet containing advice (mainly regard- Patients with sciatica still experience pain and disability 5 years after surgery: a ing activities of daily living) and suggestions for exercises, systematic review with meta-analysis of cohort studies. Eur J Pain. 2016;20: focusing on muscle strengthening, core stability and mobilisa- 1700–1709. tion. Where such usual care is provided, adding a referral for additional exercise-based rehabilitation with a physiotherapist 11. Arts MP, Peul WC, Koes BW, Thomeer RT, Leiden-The Hague Spine Intervention (one to two sessions per week for 6 to 8 weeks) is neither Prognostic Study (SIPS) Group. Management of sciatica due to lumbar disc hernia- effective nor cost-effective. tion in the Netherlands: a survey among spine surgeons. J Neurosurg Spine. 2008;9:32–39. Footnotes: aSTATA V.12, Stata Corp, College Station, USA. eAddenda: Appendices 1, 2, 3 and 4 can be found online at 12. Oosterhuis T, Costa LO, Maher CG, de Vet HC, van Tulder MW, Ostelo RW. http://dx.doi.org/10.1016/j.jphys.2017.05.016. Rehabilitation after lumbar disc surgery. Cochrane Database Syst Rev. 2014;3: Ethics approval: The Medical Ethics Review Board of the VU CD003007. University Medical Centre approved the study protocol 13. Ju S, Park G, Kim E. Effects of an exercise treatment program on lumbar extensor muscle strength and pain of rehabilitation patients recovering from lumbar disc herniation surgery. J Phys Ther Sci. 2012;24:515–518. 14. Ozkara GO, Ozgen M, Ozkara E, Armagan O, Arslantas A, Atasoy MA. Effectiveness of physical therapy and rehabilitation programs starting immediately after lumbar disc surgery. Turk Neurosurg. 2015;25:372–379. 15. Erdogmus CB, Resch KL, Sabitzer R, Müller H, Nuhr M, Schöggl A, et al. Physiother- apy-based rehabilitation following disc herniation operation: results of a random- ised clinical trial. Spine. 2007;32:2041–2049. 16. Oosterhuis T, van Tulder M, Peul W, Bosmans J, Vleggeert-Lankamp C, Smakman L, et al. Effectiveness and cost-effectiveness of rehabilitation after lumbar disc surgery (REALISE): design of a randomised controlled trial. BMC Musculoskelet Disord. 2013;14:124. 17. CBO. Richtlijn Lumbosacraal Radiculair Syndroom. Utrecht: CBO; 2008. 18. den Boer JJ, Oostendorp RA, Beems T, Munneke M, Oerlemans M, Evers AW. A systematic review of bio-psychosocial risk factors for an unfavourable outcome after lumbar disc surgery. Eur Spine J. 2006;15:527–536. 19. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31:73–86. 20. Linton SJ, Hallden K. Can we screen for problematic back pain? A screening questionnaire for predicting outcome in acute and subacute back pain. Clin J Pain. 1998;14:209–215. 21. Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–168. 22. Kraaimaat FW, Evers AW. Pain-coping strategies in chronic pain patients: psycho- metric characteristics of the pain-coping inventory (PCI). Int J Behav Med. 2003;10:343–363. 23. Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015;24:1127–1142. 24. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;25:2940–2952.
Research 153 25. Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies 39. Fergusson D, Aaron SD, Guyatt G, Hébert P. Post-randomisation exclusions: the with pain rating scales. Ann Rheum Dis. 1978;37:378–381. intention to treat principle and excluding patients from analysis. BMJ. 2002;325 (7365):652–654. 26. Ware Jr JE, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Compari- son of methods for the scoring and statistical analysis of SF-36 health profile and 40. van den Brink M, van den Hout WB, Stiggelbout AM, Putter H, van de Velde CJ, summary measures: summary of results from the Medical Outcomes Study. Med Kievit J. Self-reports of health-care utilisation: diary or questionnaire? Int J Technol Care. 1995;33(4 Suppl):AS264–AS279. Assess Health Care. 2005;21:298–304. 27. The EuroQol Group. EuroQol-a new facility for the measurement of health-related 41. McGregor AH, Doré CJ, Morris TP, Morris S, Jamrozik K. Function After Spinal quality of life. Health Policy. 1990;16:199–208. Treatment, Exercise, and Rehabilitation (FASTER): a factorial randomised trial to determine whether the functional outcome of spinal surgery can be improved. 28. Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ. Kwaliteit van Spine. 2011;36:1711–1720. leven meten in economische evaluaties: het Nederlands EQ-5D-tarief. Ned Tijdschr Geneeskd. 2005;149:1574–1578. 42. Ju S, Park G, Kim E. Effects of an exercise treatment program on lumbar extensor muscle strength and pain of rehabilitation patients recovering from lumbar disc 29. Hakkaart-van Roijen L, Tan SS, Bouwmans CAM. Handleiding voor kostenonderzoek. herniation surgery. J Phys Ther Sci. 2012;24:515–518. Methoden en standaardkostprijzen voor economische evaluaties in de gezondheids- zorg, Geactualiseerde versie 2010. College voor zorgverzekeringen; 2010. 43. Snowdon M, Peiris CL. Physiotherapy commenced within the first four weeks post- spinal surgery is safe and effective: a systematic review and meta-analysis. Arch 30. Z-Index. The Netherlands: The Hague;2009. https://www.z-index.nl/ Phys Med Rehabil. 2016;97:292–301. 31. Koopmanschap MA. PRODISQ: a modular questionnaire on productivity and dis- 44. Erdogmus CB, Resch KL, Sabitzer R, Müller H, Nuhr M, Schöggl A, et al. Physiotherapy- ease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res. based rehabilitation following disc herniation operation. Spine. 2007;32: 2041–2049. 2005;5:23–28. 32. Koopmanschap MA, Rutten FF, van Ineveld BM, van Roijen L. The friction cost 45. Johansen A, Schirmer H, Stubhaug A, Nielsen CS. Persistent post-surgical pain and method for measuring indirect costs of disease. J Health Econ. 1995;14:171–189. experimental pain sensitivity in the Tromsø study: comorbid pain matters. Pain. 33. Statistics Netherlands. Consumer price indices. statline.cbs.nl/StatWeb/publica- 2014;155:341–348. tion/?PA=71311NED&D1=0,2,4,6&D2=0-1,61,70,87,108,137,145,172,176,221-222,230, 255,l&D3=(l-34)-l&HDR=T&STB=G1,G2. Accessed 22 June 2015. 46. Louw A, Diener I, Landers MR, Puentedura EJ. Preoperative pain neuroscience 34. Ostelo RWJG, Costa LOP, Maher CG, de Vet HCW, Van Tulder MW. Rehabilitation education for lumbar radiculopathy: a multicenter randomised controlled trial after lumbar disc surgery. Cochrane Database Syst Rev. 2008;4:CD003007. with 1-year follow-up. Spine. 2014;39:1449–1457. 35. White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011;30:377–399. 47. Morris S, Morris TP, McGregor AH, Doré CJ, Jamrozik K. Function after spinal 36. Black WC. The CE Plane: A Graphic Representation of Cost-Effectiveness. Med Decis treatment, exercise, and rehabilitation: cost-effectiveness analysis based on a Making. 1990;10:212–214. randomised controlled trial. Spine. 2011;36:1807–1814. 37. Fenwick E, O’Brien BJ, Briggs A. Cost-effectiveness acceptability curves – facts, fallacies and frequently asked questions. Health Econ. 2004;13:405–415. 48. Ostelo RW, Goossens ME, de Vet HC, van den Brandt PA. Economic evaluation of a 38. Brazier JE, Roberts J. The estimation of a preference-based measure of health from behavioral-graded activity program compared to physical therapy for patients the SF-12. Med Care. 2004;42:851–859. following lumbar disc surgery. Spine. 2004;29:615–622. 49. Donceel P, Du Bois M, Lahaye D. Return to work after surgery for lumbar disc herniation. A rehabilitation-oriented approach in insurance medicine. Spine. 1999;24:872–876.
Journal of Physiotherapy 63 (2017) 154–160 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial Paul Jansons a,b, Lauren Robins a,b, Lisa O’Brien b,c, Terry Haines a,b a Physiotherapy Department, Monash University; b Allied Health Research Unit, Kingston Centre, Monash Health; c Occupational Therapy Department, Monash University, Melbourne, Australia KEY WORDS ABSTRACT Chronic disease Question: What is the effectiveness of gym-based exercise versus home-based exercise with telephone Exercise follow-up amongst adults with chronic conditions who have completed a short-term exercise program Adult supervised by a health professional? Design: A randomised, controlled trial with concealed allocation, Quality of life intention-to-treat analysis, and blinded outcome assessment at baseline and 3, 6, 9 and 12 months. Physical therapy Participants: The participants were recruited following a 6-week exercise program at a community health service. Intervention: One group of participants received a gym-based exercise program for 12 months (gym group). The other group received a home-based exercise program for 12 months with telephone follow-up for the first 10 weeks (home group). Outcome measures: Outcome measures included European Quality of Life Instrument (EQ-5D), the Friendship Scale, the Hospital and Anxiety and Depression Scale, Phone-FITT, 6-minute walk test, body mass index and 15-second sit-to-stand test. Results: There was no significant difference between study groups in the primary outcome (EQ-5D visual analogue scale, 0 to 100) across the 12-month intervention period, with an estimate (adjusted regression coefficient) of the difference in effects of 0 (95% CI À5 to 4). The gym group demonstrated slightly fewer symptoms of depression over the 12-month period compared to the home group (mean difference 0.8 points on a 21-point scale, 95% CI 0.1 to 1.6). Conclusion: Similar long-term clinical outcomes and long-term exercise adherence are achieved with the two approaches examined in this study. Participation in gym-based group exercise may improve mental health outcomes slightly more, although the mechanisms for this are unclear because there was no change in the selected measure of social isolation or other measures of health and wellbeing. This finding may also be a Type 1 error. Further research to reproduce these results and that investigates the economic efficiency of these models of care is indicated. Trial registration: ACTRN12610001035011. [Jansons P, Robins L, O’Brien L, Haines T (2017) Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial. Journal of Physiotherapy 63: 154–160] Crown Copyright © 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by- nc-nd/4.0/). Introduction diabetes. One such approach is to use short-term (4 to 6 weeks) supervised exercise programs. Supervised exercise programs in Australian Bureau of Statistics data from 2004 to 2005 demon- these populations have been shown to improve clinical health strate that approximately 70% of Australians aged > 15 years were outcomes, such as quality of life, anxiety, depression and exercise classified as sedentary or having low levels of physical activity. tolerance.3–5 However, there is evidence that exercise adherence Physical inactivity causes a significant public health burden, with declines after the programs are completed, with many people direct healthcare costs estimated at over AUD377 million per year ceasing altogether. A randomised, controlled trial with 109 parti- in Australia.1I9[_]DFT$ Chronic conditions such as coronary heart disease, cipants with chronic obstructive pulmonary disease identified that stroke, depression, and type-II diabetes contribute the greatest approximately 50% of older adults ceased exercise within 9 months burden to the Australian healthcare system.2 of completing a supervised exercise program.6 Unfortunately, the benefits of exercise are rapidly lost when exercise is ceased,7 One of the easiest and most effective ways of reducing highlighting the need to promote ongoing participation. Hence, healthcare costs in Australia might be older adults having greater there is a need to identify ways of promoting ongoing physical adherence to physical activity. There are a number of interventions activity following completion of a short-term supervised exercise to enhance physical activity in populations with chronic diseases program. such as cardiac disease, chronic obstructive pulmonary disease and http://dx.doi.org/10.1016/j.jphys.2017.05.018 1836-9553/Crown Copyright © 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Research 155 Strategies to encourage ongoing participation frequently Community Health Service, South East Melbourne, Australia. Those employ behaviour change techniques. Three main approaches referred to this service typically have: multiple co-morbidities; have been used: home-based exercise programs with no follow- poor or declining mobility; physical de-conditioning; or a up,8 gym-based exercise programs,9–14 or home-based exercise combination of these problems. Mixed population rehabilitation programs with telephone follow-up.6 Home-based prescribed groups are a potentially useful mechanism of service delivery for physical activity programs with telephone support are thought to regional areas where throughput within a specific diagnostic work by embedding exercise into daily routine, and avoiding the grouping is insufficient to justify a disease-specific rehabilitation need for travel to an exercise centre. However, they may fail by not program (eg, pulmonary rehabilitation). We excluded people with facilitating inter-personal connections between the individual and acute psychiatric impairment or cognitive impairment that made his/her peers, and by the prescriber having limited capacity to the person unsuitable for participation in a gym-based or home- monitor the person’s physical progress. Structured gym-based based exercise program, as determined by health service staff. programs may have an advantage over home-based programs, by Partners and/or couples were also excluded from participation. controlling the amount and quality of direct training and supervision, allowing personal attention and immediate verbal Intervention feedback from the exercise facilitator. Motivation for exercise may also be enhanced via social support and interaction between Gym-based exercise program exercise group members with similar health issues.15 However, Participants allocated to the gym-based intervention were there are conflicting findings across these studies as to which of these follow-up approaches is more effective, and none have yet given a 12-month, individualised, exercise program. An exercise undertaken a head-to-head comparison in a regional, suburban, physiologist from the community health service supervised this at single-site, community health centre. the gym from Monday to Friday for 2 hours per day. This meant that there was a person present at the gym with whom the The aim of this study was to compare the effectiveness of a participant already had a pre-established relationship from when home-based exercise program with telephone follow-up to a gym- they had completed the initial short-term supervised exercise based follow-up program amongst adults with a variety of chronic program. Participants were encouraged to attend during the times conditions and who had completed a short-term exercise program that the exercise physiologist attended the gym. However, supervised by a health professional. participants were able to independently attend the gym during off-peak times (Monday to Friday 08:00 to 16:00). Each participant Therefore, the research question for this randomised, controlled was encouraged to complete a 1-hour exercise session, three times trial was: per week. They were required to pay the standard casual entry fee of AUD5 per visit to the gym. The exercise prescription adhered to What is the effectiveness of gym-based exercise versus home- the American College of Sports Medicine guidelines for chronic based exercise with telephone follow-up amongst adults with health conditions.16 chronic conditions who have completed a short-term exercise program supervised by a health professional? The prescribed exercise included strengthening, aerobic and stretching exercise components. The strengthening component Method involved 40 minutes of six to eight strength training exercises for the upper and lower body (eg, leg press, calf raise, bicep curl, Design triceps push-down, lateral pull-down, chest press or scapula retraction) using pin-loaded resistance equipment, unless contra- This was a randomised, controlled trial with concealed indicated. Participants were prescribed a two-set repetition allocation, and blinded outcome assessments conducted at maximum per exercise set at a moderate intensity of approxi- baseline (ie, at the completion of the short-term supervised mately 60% of their 10-repetition maximum. The aerobic compo- exercise program), 3, 6, 9 and 12 months. Prior to enrolment, all nent of the exercise involved up to 15 minutes of stationary bike, participants received an initial health assessment (also used to treadmill or cross trainer. The rating of perceived exertion scale obtain participant baseline demographic data) from an exercise was used to monitor a safe ‘moderate’ intensity.17 The stretching physiologist and then completed a 6-week supervised exercise component involved 5 minutes of upper and lower limb stretching program at a community health service. This consisted of 1-hour (eg, pectoral, shoulder, calf, hamstring and quadriceps) with two group exercise sessions, with participants encouraged to attend repetitions of each static stretch prescribed for 30 seconds. The three sessions per week. Each participant was provided with a healthcare professionals providing the intervention were trained home-based exercise program at the conclusion of the supervised in the Health Coaching Australia model that uses motivational exercise program. Exercise physiologists collected baseline data for interviewing techniques, solution-focused coaching and cognitive this trial at the discharge assessment of the short-term supervised behavioural therapy techniques to identify techniques and address program. Patients were then randomised to one of the two 12- behavioural, emotional, situational and cognitive barriers to month intervention programs. Randomisation involved the inves- exercise adherence.18 tigator opening a sealed, opaque envelope containing the random allocation sequence, which was developed by a separate investi- Home-based program with telephone support gator with no knowledge of participants’ baseline results. This Participants allocated to the home-based intervention were sequence was set out in permuted blocks of 4, 6 and 8, and was stratified by the participant’s primary chronic disease diagnosis also given a 12-month, individualised, exercise program. Each type (pulmonary, musculoskeletal, diabetes, other). A blinded participant was encouraged to complete a 1-hour exercise session, research assistant conducted the reassessments at 3, 6, 9 and three sessions per week, at home. The home-based exercise 12 months. Participants were not blinded to group allocation; program was supervised via five telephone calls over the first therefore, their self-reported outcomes could not be considered to 10 weeks, approximately 25 to 30 minutes in duration. The total be blinded. However, the research assistants who administered the time in minutes to complete the five phone calls for each physical tests were blinded. participant was comparable to that spent supervising each participant in the gym over a 12-month intervention period. The Participants, therapists and centres exercise physiologist supervising the telephone intervention was also trained in the Health Coaching Australia Model. The same Participants were recruited from a pool of adults who had exercise physiologists who provided supervision for the gym- completed a 6-week exercise program at the Cardina Casey based program also provided the supervision for the home-based program, ensuring equivalence in the experience and educational background of the providers of each of these interventions.
156 Jansons et al: Gym versus home-based exercise for chronic disease The exercise prescription aimed to be comparable to that of the (such as lifting weights or playing sport), and total physical gym-based program. It also adhered to the American College of activity. A total physical activity (PA) summary score between Sports Medicine guidelines for chronic health conditions,16 with 0 and 209 can be derived from the frequency and duration data strength, aerobic and stretching components comparable to the by multiplying the two across all questions and adding the gym-based program. The strength-training component involved products. A higher score signifies greater participation in six to eight exercises for the upper and lower body (eg, sit to stand, physical activity. calf raise, bicep curl, triceps push-down, lateral pull-down, chest press or scapula retraction) using body weight or an elastic Attendance at the community-based fitness centre over the exercise banda to provide resistance. The aerobic component 12 months was measured via gym scanning software that included community walking or, if participants had access to their recorded client attendance. Participation in alternate forms of own exercise equipment such as a stationary bike, this was physical activity was measured at follow-up assessments at 3, 6, incorporated. 9 and 12 months, with a patient-recorded logbook. Participation in the home-based exercise program was measured using the Outcome measures patient’s logbook and collated at the 3, 6, 9 and 12-month assessments. Primary outcome Health-related quality of life was assessed using the European An adverse event was any injury or exacerbation of existing illness that required medical attention while participating in either Quality of Life Instrument (EQ-5D).19 This questionnaire contains intervention and was measured using the patient logbook at 3, 6, five multiple-choice questions and a 100-point overall health 9 and 12 months. state visual analogue scale. The five questions reflect mobility, personal care, usual activities, pain/discomfort and anxiety/ A range of other outcomes measures that were relevant to an depression. The respondent selects one of three ordinal state- economic evaluation of this trial were also collected, but will not be ments to describe their health for each. In order to obtain an reported in this clinical trial report. overall score, the Dolan utility calculator20 was applied. A utility score is determined where 0 represents death and 1 perfect Data analysis health. Test-retest reliability for community-based adults follow- ing stroke is 0.83 at 3 weeks and 0.86 at 3 months.21 A minimum Each of the outcomes was compared between groups using clinically important difference using this calculation approach for linear regression analyses. Data were clustered within individual the EQ-5D amongst mixed chronic diagnosis groups has been participants and robust (Huber-White) variance estimates were estimated to be 0.074.22 used.34T_0]$DFI1[ Each analysis compared groups across all follow-up assessments simultaneously with adjustment for baseline scores Secondary outcomes for that same outcome. A group-by-assessment time point Productivity was measured using the Health and Labour interaction effect was also examined to see if there was a difference in the rate of change in an outcome between groups. Questionnaire.23 This questionnaire contains methods for calcu- Alpha criterion level was set at p = 0.05. All analyses were lating productivity losses that are not the sole result of absentee- conducted using STATA softwareb. ism.23 A sample size of 52 participants per group was required for this Social activity was measured using the Friendship Scale, which experiment to have 90% power to detect a 7-point change in the is a short and user-friendly instrument that measures six EQ-5D visual analogue scale of global health-related quality-of-life dimensions contributing to social isolation and social connec- at the 12-month follow-up assessment. Many minimum clinically tion.24 A score between 0 and 24 is obtained; higher scores indicate important difference levels have been established for the EQ-5D less social isolation. visual analogue scale across a range of patient populations with chronic disease, although a 7-point change is a standard that is Depression and anxiety were measured using the Hospital commonly employed.35]_TI$F[1D A standard deviation of 11 points was used Anxiety and Depression Scale.25 This scale includes 14 items, seven on the basis of a pre-trial survey of 20 patients within the target of which relate to an anxiety subscale and seven to a depression group conducted by the investigators. A 10% participant attrition subscale. Each item is scored between 0 and 3, and a sub-scale rate was accommodated for; thus we aimed to recruit 57 partici- score > 8 indicates a possible case and a score > 10 a probable pants per group. case.25 Results Body mass index (BMI) was determined by body weight in kilograms divided by height in metres squared.26 Body mass index Flow of participants, therapists and centres through the study has been shown to predict cardiac mortality across a 15-year span.27 Participant movement through the study is illustrated in Figure 1. The 15-second sit-to-stand test28 was included, as it is commonly used to measure lower limb strength in older people. Characteristics of participants The test-retest reliability was established to be excellent (ICC = 0.96) in a study assessing older adults with knee or hip A summary of the demographics of the participants is osteoarthritis.29 In a study examining mobility tests for predicting presented in Table 1 and the baseline scores on the outcome multiple falls in community-dwelling older adults, good test-retest measures are presented in the first two columns of Table 2. The two reliability was reported (ICC = 0.89).30 groups were broadly similar at baseline, although some discre- pancies in characteristics were evident in terms of the proportion The 6-minute walk test,31 which measures the distance a of married participants; 42/54 (78%) in the gym group compared to participant is able to walk in 6 minutes, was performed once per 31/51 (61%) in the home group, and for the proportion who were participant at each time point, using the American Thoracic Society widowed; 12/54 (24%) in the home group compared to 2/51 (4%) in guidelines. In community-dwelling adults aged ! 65 years, the 6- the gym group. The gym group were more likely to be born in minute walk test showed correlations with the Short Physical Australia (78 versus 60%), more likely to have a primary diagnosis Performance Battery (0.61), chair stand time (–0.62), habitual gait of cancer (39 versus 23%) or diabetes (39 versus 23%) and less likely (0.80), maximal gait (0.80) and stair climb time (–0.83).32 to have lung disease (24 versus 45%). Physical activity was measured using the Phone-FITT,33 which is a self-reported questionnaire about the frequency, intensity, time and type of physical activity undertaken. The Phone-FITT allows respondents to report on household activity (such as cooking, cleaning and gardening), recreational physical activity
(Figu[e_1)TD$rIG] Research 157 People referred to the Cranbourne Community Health Exercise Program from June 2011 to June 2013 (n = 139) Ineligible (n = 8) Invited to participate in the study (n = 131) Declined to participate (n = 26) • wanted gym program (n = 22) • wanted home program with telephone support (n = 4) Measured EQ-5D, Friendship Scale, HADS, BMI, sit-to-stand, 6MWD and Phone-FITT Month 0 Randomised (n = 105) (n = 51) (n = 54) Lost to follow-up Home Group Gym Group Lost to follow-up • full-time work (n = 1) • home exercise program • gym exercise program • full-time work (n = 1) • medical issue (n = 1) strength/aerobic/stretch • medical issue (n = 2) strength/aerobic/stretch • 60-min sessions • 60-min sessions • 3 sessions per week • 3 sessions per week • telephone support Month 3 Measured EQ-5D, Friendship Scale, HADS, Phone-FITT, adherence and adverse events (n = 49) (n = 51) Lost to follow-up Home Group Gym Group Lost to follow-up • died (n = 1) • home exercise program • gym exercise program • hospitalised (n = 1) strength/aerobic/stretch • died (n = 1) strength/aerobic/stretch • 60-min sessions • 60-min sessions • 3 sessions per week • 3 sessions per week Measured EQ-5D, Friendship Scale, HADS, BMI, sit-to-stand, 6MWD, Phone-FITT, Month 6 adherence and adverse events (n = 48) (n = 49) Lost to follow-up Home Group Gym Group Lost to follow-up • medical issue (n =1) • as above • as above • unable to attend (n = • died (n = 1) • hospitalised (n = 1) 1) Month 9 Measured EQ-5D, Friendship Scale, HADS, Phone-FITT, adherence and adverse events (n = 45) (n = 48) Lost to follow-up Home Group Gym Group Lost to follow-up • hospitalised (n = 1) • home exercise program • gym exercise program • unable to attend (n = • overseas (n = 2) strength/aerobic/stretch • unable to attend (n = strength/aerobic/stretch 2) • 60-min sessions • 60-min sessions 3) • 3 sessions per week • 3 sessions per week Month 12 Measured EQ-5D, Friendship Scale, HADS, BMI, sit-to-stand, 6MWD, Phone-FITT, adherence and adverse events (n = 39) (n = 46) Figure 1. Design and flow of participants through the trial. Effects of the interventions time interaction effect to identify whether the effect of group allocation changed over follow-up time points. There was no A summary of the primary and secondary outcome measures is significant difference between study groups in the EQ-5D (primary presented in Table 2. (Individual participant data are presented in outcome) across the 12-month follow-up. The gym group Table 3. See eAddenda for Table 3). The regression coefficients that demonstrated fewer symptoms of depression (Hospital Anxiety are presented represent the between-group difference averaged and Depression Scale - depression subscale) over the 12 months of across the follow-up time points adjusted for baseline scores. A follow-up compared to the home group (p = 0.02); however, this second coefficient is also presented representing the group-by- was the only significant between-group difference observed.
158 Jansons et al: Gym versus home-based exercise for chronic disease Table 1 encountered. The Lubben Social Network Scale36 may have been Baseline demographics and outcome measure scores for both groups. preferable for this purpose, as it is a measure of social network size rather than one of loneliness and the ability to interact with others Characteristic Home Gym (as is the Friendship Scale). It is possible that a mechanism of action (n = 51) (n = 54) not mediated via social interaction may also have been responsible for this finding. For example, having to go to the gym forces people Age (yr), mean (sd) 66 (13) 68 (11) to leave their house, which has potential mental health benefits Gender, n female (%) 38 (75) 29 (54) from experiencing new environments or being exposed to sunlight Marital status, n (%) while travelling to the gym.37,38 It is also possible that this may 31 (61) 42 (78) have been a Type 1 statistical error, given the number of secondary married 12 (24) 2 (4) outcomes that were examined. Overall, the mechanism for the widowed 7 (13) between-group difference in depression symptoms was unclear divorced 4 (8) 1 (2) and warrants repeated investigation to reproduce this result and to separated 3 (6) 2 (4) more deeply examine the potential mechanism of action. It was never married 1 (2) encouraging, however, that the health states attained at the end of Country of birth, n (%) 42 (78) the initial program were largely maintained at 12 months in both Australia 31 (61) 3 (6) groups. United Kingdom 4 (8) 9 (17) other To date, this study is the first to directly assess the effectiveness Medical conditions, n (%) 16 (31) 12 (22) of gym-based follow-up compared with home-based follow-up via congestive heart failure 47 (87) telephone support amongst people with chronic diseases who other heart disease a 12 (24) 12 (22) have just completed a supervised exercise program. A recent stroke b 45 (88) 6 (11) review identified 11 studies that have previously examined one of cancer 9 (18) these interventions compared to a control. Meta-regression osteoporosis or osteopenia 11 (22) 4 (7) analyses found no differential effect of follow-up approach on depression or anxiety 23 (43) the rates of adherence to the exercise programs that had been arthritis 2 (4) 21 (39) prescribed.39 The present study concurred with this finding, in that diabetes 20 (39) 21 (39) it identified no difference in adherence rates between the two lung disease cD$5F_][TI 20 (39) 13 (24) follow-up approaches. It is still possible, however, that the Parkinson’s disease 12 (24) different approaches may have different therapeutic outcomes inner ear dysfunction d 23 (45) 0 (0) despite similar adherence rates. It could be postulated that cataracts 5 (9) exercising in a gym environment with a range of available other visual impairment 1 (2) 0 (0) equipment may enhance the ability of participants to exercise at broken bone since turning 60 2 (4) 11 (20%) a higher intensity. Further research would be required to see if this joint replacement 0 (0) 8 (15%) is the case. Health service indicator, mean (SD) 11 (22) 18 (33) hospitalised for ! 1night in past 3 mth 11 (22) A limitation of the present study was that it did not meet the Health insurance status, n (%) 15 (29) 7.3 (9.3) planned sample size of 114 participants. This study was conducted private health insurance in a somewhat regional suburban centre approximately 40 km Department of Veterans’ Affairs 0 (0) 14 (26) from a major metropolitan city (Melbourne, Australia). The study 3 (6) location served as the single, major community health centre 11 (22) location for this area, meaning that many of the current and 1 (2) potentially future participants in this study often interacted with each other at this centre. Consequently, study recruiters noted that Gym = Gym-based exercise group, Home = Home-based exercise with telephone potential participants were becoming increasingly aware of the study prior to being approached as the study progressed. These support group. ‘study aware’ individuals were forming preferences for study a Includes coronary heart disease, cardiomyopathy, ischaemic heart disease, allocation grouping (usually centre-based), which then affected recruitment, in that people who did not prefer centre-based hypertensive heart disease, inflammatory heart disease, disease affecting one or follow-up were disproportionately refusing to enter the study. A meeting of study investigators determined that it was better to more valves of the heart, and heart murmur. cease the recruitment early at 105 rather than recruit a biased b Includes stroke, mini-strokes, aneurisms, and transient-ischaemic attacksIFD$T.][7_ sample into the study. A consequence of this was that the study had c Includes asthma, emphysema, chronic obstructive pulmonary disease, and lower statistical power than anticipated and that Type II statistical errors may have been made. A review of the analyses of the primary chronic obstructive airways disease_$T8IFD.[] and secondary outcomes indicates that this may have been an issue d Affecting balance (eg, dizziness). for the Hospital Anxiety Depression Scale – Anxiety subscale. Adherence to the interventions The present study was not able to determine whether the exercise participation rates or health outcomes would have been The mean number of exercise sessions completed at the 12- any better for this patient population if a ‘no follow-up’ control month follow-up was 52 sessions (SD 43, range 0 to 156) in the condition been employed. Reis et al121[2]D_TIF$ and Berry et al10 found that home group compared to 53 sessions (SD 34, range 8 to 150) in the following the completion of a short-term, supervised, pulmonary gym group. The proportion of people fully adherent (defined as exercise program, the initial gains in 6-minute walk test distance three sessions completed per week) was 34% in the gym group and significantly declined with a ‘no follow-up’ control compared to a 33% in the home group. centre-based exercise intervention. The Short Form-36 quality of life questionnaire scores12 and the Fitness Arthritis and Seniors Adverse events Trial functional performance inventory10 also significantly de- clined with a ‘no follow-up’ control. In contrast, the present 12- No participants in either group reported any adverse events month follow-up indicated that health outcomes were largely after completing the allocated intervention. unchanged over this period for people allocated to either of the two follow-up approaches. One could also question whether the Discussion adherence rates observed in this study were sufficient to generate This study has identified that gym-based and telephone follow- up approaches produce similar longer-term outcomes in people with chronic diseases who have recently undertaken a 6-week, centre-based, supervised exercise program. The only apparent difference in outcomes was identified for the Hospital Anxiety and Depression Scale (depression subscale) outcome. It had been anticipated that a gym-based program might produce superior mental health outcomes mediated via the social interaction that participants would have participated in while at the gym. However, no change was found in the measure of social isolation, bringing this hypothesis into question. It is possible that the measure of social isolation (the Friendship Scale) was not the correct scale to measure the change in the amount of social interaction a person
Research 159 Table 2 Mean (SD) of groups, adjusted regression coefficient (95% CI), and group-by-time interaction coefficient (95% CI). Outcome Groups Adjusteda]D$FT_6[I Group-by- regression time coefficient interaction (95% CI) coefficient (95% CI) Month 0 Month 3 Month 6 Month 9 Month 12 Home Gym Home Gym Home Gym Home Gym Home Gym Home minus Home minus Gym (n = 51) (n = 54) (n = 49) (n = 51) (n = 48) (n = 49) (n = 45) (n = 48) (n = 39) (n = 46) Gym EQ-5D, mean (SD) 70 69 64 67 70 70 69 67 72 68 0 2 VAS (0 to 100) (17) (15) (17)c (18) (15)e (14)f (18)f (17)d (17) (17) (–5 to 4) (0 to 4) 0.67 0.63 0.59 0.68 0.67 –0.02 Utility (–0.594 to 1.0) (0.21) (0.26) 0.65 (0.28) 0.67 0.67 0.66 0.66 (0.22) (0.25) –0.00 (–0.05 to 0.02) 19.2 19.2 (0.22)c 19.2 (0.25)e (0.25)f (0.22)f (0.23)d 17.1 17.5 (–0.06 to 0.06) Friendship Scale (0 to 24), (3.9) (4.2) (4.5) (4.4)c (4.2) 0.0 mean (SD) 19.0 19.8 19.7 19.1 20.0 –0.1 (–0.5 to 0.4) 5.5 5.3 (4.4)d (4.1)e (3.4)f (4.5)f (3.9)f (–1.0 to 0.8) HADS (0 to 21), mean (SD) (2.9) (3.3) Depression 6.5 5.8 6.5 5.1 5.5 4.8 5.6 4.5 5.7 4.6 0.8 –0.1 (3.9) (3.9) (3.6)d (3.4) (3.3)e (3.4)f (4.2)f (2.9)f (0.1 to 1.6) (–0.5 to 0.3) Anxiety 30.7 32.7 5.5 6.6 4.6 (3.0) (3.2) (8.2) (8.6) 7.0 (4.2) 4.6 5.8 (3.9)f (3.8)f 0.8 0.1 Body mass index (kg/m2), mean (SD) 4.5 4.7 (3.9)d (3.8)g (4.0)f 7.1 5.5 (–0.1 to 1.8) (–0.3 to 0.5) (1.5) (1.3) 45 46 46 Sit-to-stand test, mean (SD) b 373 378 46 (14) 31.0 32.8 (17)e (14)d (3.9) (4.4) 0.3 –0.1 (101) (99) (15)d (8.0)h (8.9)i (–0.3 to 0.9) (–0.5 to 0.3) 6-minute walk test (m), mean (SD) 31.2 32.5 43 48 5.0 5.3 (7.8)j (8.3)f 0.0 0.2 Phone-FITT Sum Score, mean (SD) (15) (13) (2.3)h (1.9)i (–0.5 to 0.5) (–0.1 to 0.6) 5.3 5.1 384 400 (1.9)j (1.6)d –12 –5 (107)h (97)i (–35 to 12) (–18 to 8) 385 409 49 50 (127)j (84)f 2 0 (20)e (18)d (–2 to 6) (–3 to 2) 47 48 (18)c (16)c EQ-5D = European Quality of Life Instrument, Gym = Gym-based exercise group, HADS = Hospital Anxiety & Depression Scale, Home = Home-based exercise with telephone support group. Shaded row = primary outcome. a Adjusted for baseline value. b Number of sit-to-stands without hand support in 15 seconds, average of two tests. c One missing data point. d Two missing data points. e Four missing data points. f Three missing data points. g Six missing data points. h Fourteen missing data points. i Five missing data points. j Seven missing data points. a physiological benefit for participants, as both groups only telephone follow-up for people with chronic diseases who had participated on average in one session per week. Previous research recently undertaken a 6-week, centre-based, supervised, exercise has identified that one session per week after previously program. This was with the exception that gym-based follow-up completing a more intensive program is sufficient to maintain may improve mental health outcomes. However, the mechanism muscle strength, particularly when compared to completely for this was unclear, as there was no change in the selected stopping exercise participation.401F[I]3$D_T measure of social isolation or other measures of health and wellbeing. Future research that investigates the cost-effectiveness The present study had some other limitations. It was impossible of each follow-up approach should be considered. to blind participants or people delivering the intervention as to group allocation. In the home-based group with telephone What is already known on this topic: Supervised exercise support, participants’ self-reported adherence was recorded using programs in adults with a chronic disease improve clinical logbooks, whereas in the gym-based group, attendance at the gym status. Unfortunately, many adults do not persist with the was recorded through electronic scanning of a membership card. It exercise after the supervised program, thereby losing the is anticipated that the self-report approach may be more prone to benefits they have obtained. spuriously inflated scoring by study participants leading to an What this study adds: Adults with a chronic disease who overestimate of exercise adherence rates in this group. have recently completed a supervised exercise program achieve similar outcomes and maintain similar exercise ad- This research has implications both for clinical practice and herence a year later with either a gym-based maintenance future research. Clinicians could justifiably employ either of these exercise program or a home-based maintenance exercise follow-up approaches in clinical practice, although use of an program with telephone support. The gym-based program approach that minimises overall healthcare resource use and may improved mental health outcomes more, but this finding aligns with patient preferences is recommended. As such, future requires further investigation. research that investigates the cost-effectiveness of each follow-up approach should be considered. Furthermore, there is a need to Footnotes: a TherabandTM, The Hygenic Corporation, Akron, USA. compare these approaches in this patient population with a ‘no eAddenda: Table 3 can be found online at: http://dx.doi.org/10. follow-up’ control to ensure that it is worthwhile pursuing either 1016/j.jphys.2017.05.018. of these follow-up approaches. Future research could also take the Ethics approval: The Southern Health Medical Research Ethics form of a 4F_D$1Im[]T ulticentre trial varying location (regional versus Committee; Number: 10187L approved this study. All participants metropolitan) to investigate whether this factor influences the gave written informed consent before data collection began. relative effectiveness and economic efficiency of either approach. This study identified no difference in outcomes between the gym-based approach and the home-based approach with
160 Jansons et al: Gym versus home-based exercise for chronic disease Competing interests: The author(s) declared no potential 16. Moore G, Durstine JL, Painter P. ACSM’s Exercise Management for Persons With Chronic Diseases and Disabilities, American College of Sports Medicine. 4E. Human conflicts of interest with respect to the research, authorship, Kinetics; 2016. and/or publication of this article. 17. Scherr J, Wolfarth B, Christle JW, Pressler A, Wagenpfeil S, Halle M. Associations Source of support: Terry Haines was supported by a Career between Borg’s rating of perceived exertion and physiological measures of exercise Development Fellowship from the Australian National Health and intensity. Eur J Appl Physiol. 2013;113:147–155. Medical Research Council. 18. Gale J. The Health Coaching Australia (HCA) model: an integrated model of health Acknowledgements: Management and staff at Cardina Casey behaviour change for chronic disease prevention and chronic condition self- management. Health Coaching Guide for Health Practitioners: Using the HCA model Community Health Service, Monash Health and Genesis Fitness, of Health Coaching. 2010. Cranbourne. 19. Rabin R, de Charro F. EQ-SD: a measure of health status from the EuroQol Group. Provenance: Not invited. Peer reviewed. Ann Med. 2001;33:337–343. Correspondence: Paul Jansons, Allied Health Research Unit, 20. Dolan P, Roberts J. Modelling valuations for Eq-5d health states: an alternative Kingston Centre, Monash Health, Melbourne. Email: paul.jansons@ model using differences in valuations. Med Care. 2002;40:442–446. monashhealth.org 21. Dorman P, Slattery J, Farrell B, Dennis M, Sandercock P. Qualitative comparison of References the reliability of health status assessments with the EuroQol and SF-36 question- naires after stroke. Stroke. 1998;29:63–68. 1. Australian Bureau of Statistics. Physical activity in Australia: a snapshot, 2004-05. Australia: ABS Canberra; 2011. 22. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14: 2. Stephenson J, Bauman A, Armstrong T. The cost of illness attributable to physical 1523–1532. inactivity in Australia: a report prepared for the commonwealth department of health and aged care and the Australian sports commission. Canberra: The Commonwealth 23. Hakkaart-van Roijen L, Bouwmans C. Handleiding Short Form-Health and Labour Department of Health and Aged Care and the Australian Sports Commission, Questionnaire [Manual Short Form-Health and Labour Questionnaire]. Rotterdam: Population Health Division Publications; 2000. Institute for Medical Technology Assessment/Erasmus Universitair Medisch Cen- trum Rotterdam; 2007. 3. Cambach W, Wagenaar RC, Koelman TW, van Keimpema T, Kemper HC. The long- term effects of pulmonary rehabilitation in patients with asthma and chronic 24. Hawthorne G. Measuring social isolation in older adults: development and initial obstructive pulmonary disease: a research synthesis. Arch Phys Med Rehabil. validation of the friendship scale. Soc Indic Res. 2006;77:521–548. 1999;80:103–111. 25. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr 4. Griffiths TL, Burr ML, Campbell IA, Lewis-Jenkins V, Mullins J, Shiels K, et al. Results Scand. 1983;67:361–370. at 1 year of outpatient multidisciplinary pulmonary rehabilitation: a randomised controlled trial. Lancet. 2000;355(9201):362–368. 26. Deurenberg P, Weststrate JA, Seidell JC. Body mass index as a measure of body fatness: age-and sex-specific prediction formulas. Brit J Nutr. 1991;65:105–114. 5. Singh S, Smith D, Hyland M, Morgan M. A short outpatient pulmonary rehabilita- tion programme: immediate and longer term effects on exercise performance and 27. Oppert J-M, Charles M-A, Thibult N, Guy-Grand B, Eschwège E, Ducimetière P. quality of life. Respir Med. 1998;92:1146–1154. Anthropometric estimates of muscle and fat mass in relation to cardiac and cancer mortality in men: the Paris Prospective Study. Am J Clini Nutr. 2002;75:1107–1113. 6. Brooks D, Krip B, Mangovski-Alzamora S, Goldstein R. The effect of postrehabilita- tion programmes among individuals with chronic obstructive pulmonary disease. 28. Bohannon RW. Sit-to-stand test for measuring performance of lower extremity Eur Respir J. 2002;20:20–29. muscles. Percept Mot Skills. 1995;80:163–166. 7. Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in 29. Lin Y, Davey R, Cochrane T. Tests for physical function of the elderly with knee and older adults: an updated meta-analysis and best practice recommendations. N S W hip osteoarthritis. Scand J Med Sci Sports. 2001;11:280–286. Public Health Bull. 2011;22:78–83. 30. Tiedemann A, Shimada H, Sherrington C, Murray S, Lord S. The comparative ability 8. Roessler KK, Ibsen B. Promoting exercise on prescription: Recruitment, motivation, of eight functional mobility tests for predicting falls in community-dwelling older barriers and adherence in a Danish community intervention study to reduce type people. Age Ageing. 2008;37:430–435. 2 diabetes, dyslipidemia and hypertension. J Public Health. 2009;17:187–193. 31. American Thoracic Society. ATS statement: guidelines for the six-minute walk test. 9. Beauchamp MK, Francella S, Romano JM, Goldstein RS, Brooks D. A novel approach Am J Respir Crit Care Med. 2002;166:111–117. to long-term respiratory care: Results of a community-based post-rehabilitation maintenance program in COPD. Respir Med. 2013;107:1210–1216. 32. Mijnarends DM, Meijers JM, Halfens RJ, ter Borg S, Luiking YC, Verlaan S, et al. Validity and reliability of tools to measure muscle mass, strength, and physical 10. Berry MJ, Rejeski WJ, Miller ME, Adair NE, Lang W, Foy CG, et al. A lifestyle activity performance in community-dwelling older people: a systematic review. J Am Med intervention in patients with chronic obstructive pulmonary disease. Respir Med. Dir Assoc. 2013;14:170–178. 2010;104:829–839. 33. Gill DP, Jones GR, Zou G, Speechley M. The Phone-FITT: a brief physical activity 11. Cockram J, Cecins N, Jenkins S. Maintaining exercise capacity and quality of life interview for older adults. J Aging Phys Act. 2008;16:292–315. following pulmonary rehabilitation. Respirology. 2006;11:98–104. 34. White H. A heteroskedasticity-consistent covariance matrix estimator and a direct 12. Ries AL, Kaplan RM, Myers R, Prewitt LM. Maintenance after pulmonary rehabili- test for heteroskedasticity. Econometrica. 1980;817–838. tation in chronic lung disease: a randomized trial. Am J Respir Crit Care Med. 2003;167:880–888. 35. McPhail S, Beller E, Haines T. Two perspectives of proxy reporting of health-related quality of life using the Euroqol-5D, an investigation of agreement. Med Care. 13. Ringbaek T, Brøndum E, Martinez G, Thøgersen J, Lange P. Long-term effects of 1- 2008;46:1140–1148. year maintenance training on physical functioning and health status in patients with COPD: a randomized controlled study. J Cardiopulm Rehabil Prevent. 2010; 36. Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, et al. 30:47–52. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006; 14. Spencer L, Alison J, McKeough Z. Maintaining benefits following pulmonary 46:503–513. rehabilitation: a randomised controlled trial. Eur Respir J. 2010;35:571–577. 37. Benedetti F, Colombo C, Barbini B, Campori E, Smeraldi E. Morning sunlight reduces 15. Cox KL, Burke V, Morton AR, Gillam HF, Beilin LJ, Puddey IB. Long-term effects of length of hospitalization in bipolar depression. J Affect Disord. 2001;62:221–223. exercise on blood pressure and lipids in healthy women aged 40-65 years: The Sedentary Women Exercise Adherence Trial (SWEAT). J Hypertens. 2001;19: 38. Ng F, Dodd S, Berk M. The effects of physical activity in the acute treatment of 1733–1743. bipolar disorder: a pilot study. J Affect Disord. 2007;101:259–262. 39. Jansons P, Haines T, O'Brien L. Interventions to achieve ongoing exercise adherence for adults with chronic health conditions who have completed a supervised exercise program: Systematic review and meta-analysis. Clin Rehabil. 2017;31: 465–477. 40. Graves JE, Pollock ML, Leggett SH, Braith RW, Carpenter DM, Bishop LE. Effect of reduced training frequency on muscular strength. Int J Sports Med. 1988;9: 316–319.
Journal of Physiotherapy 63 (2017) 184 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers Intensive preoperative rehabilitation improves functional capacity and postoperative hospital length of stay in elderly patients with lung cancer Synopsis Summary of: Lai Y, Huang J, Yang M, Su J, Liu J, Che G. Seven-day function, 6-minute walk distance and quality of life (European Organiza- intensive preoperative rehabilitation for elderly patients with lung tion for Research and Treatment of Cancer QLQ-C30 and LC13_CN Version cancer: a randomized controlled trial. J Surg Res. 2017;209:30-36. 3) collected before and after the preoperative rehabilitation period. Results: The intervention group had a lower incidence of postoperative Question: In elderly patients undergoing thoracic surgery for non-small pulmonary complications (13.3% versus 36.7%, ARR = 0.23, 95% CI 0.01 to cell lung cancer, does a program of preoperative rehabilitation decrease 0.43). The intervention group had a shorter postoperative and total in- postoperative pulmonary complications? Design: Randomised, con- hospital length of stay (mean difference 3.8 days, 95% CI 1.0 to 6.6 and trolled trial with outcome assessor blinding. Setting: A single Chinese 3.7 days, 95% CI 0.8 to 6.6, respectively). The intervention group also hospital. Participants: Inclusion criteria were being aged 70 years with demonstrated a greater increase in 6-minute walk distance (mean dif- a definite diagnosis of primary non-small cell lung cancer and a willing- ference in change 19.2 m, 95% CI 2.1 to 36.3) and peak expiratory flow ness to undergo lobectomy via thoracic surgery. Exclusion criteria were: (mean difference 18.0 l/min, 95% CI 8.9 to 27.1) but no other differences in oxygen saturation < 90% during the 6-minute walk test, high risk of respiratory function tests or quality of life. Conclusion: A program of adverse events (myocardial infarction or cerebrovascular accident in past preoperative rehabilitation therapy reduced postoperative pulmonary year, unstable angina, aneurysm, haemoptysis, severe arrhythmia, mus- complications and hospital length of stay, and increased functional culoskeletal or mental disorder) or sub-resection/pneumonectomy. Ran- capacity in elderly thoracic surgery patients with non-small cell lung domisation of 60 participants allocated 30 to an intervention group and cancer. F[D_]2$1T[I 95% CIs for postoperative pulmonary complications, postopera- 30 to a control group. Interventions: Participants in the intervention tive and in-hospital length of stay calculated by the CAP EditorFD.T$01I[_]3 ] group received 7 days of rehabilitation, which comprised breathing exercises (performed on the ward three times/day) and aerobic endur- Provenance: Invited. Not peer reviewed. ance training via a recumbent cross trainer with resistance set by the patient (performed in a rehabilitation centre for 30 min/day). Partici- Elizabeth H Skinner pants in the control group received usual preoperative care. Outcome Department of Physiotherapy, Monash University, Australia measures: The primary outcome was the 30-day incidence of postopera- tive pulmonary complications. Secondary outcomes included postoper- http://dx.doi.org/10.1016/j.jphys.2017.05.004 ative and total in-hospital length of stay, D1FI$m_][T easures of resting lung © 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/). Commentary Surgical resection provides the best chance of cure for patients with absolute risk reduction in postoperative complications is wide, early stage lung cancer. Despite advances in surgical techniques, indicating that the true effect of this intervention on postoperative postoperative morbidity remains common. It is paramount to avoid complications may be substantially weaker or substantially stronger postoperative complications, as they can prolong admission times and than the absolute risk reduction estimate of 0.23. Finally, the secondary lead to poorer functional outcomes. In addition, lower preoperative outcome – mean difference in 6-minute walk distance (19 m, 95% CI exercise capacity is an established predictor of poor outcomes.1 2 to 36 m) – was not clinically significant when compared with the lung cancer minimum clinically important difference of 22 to 42 m.4 Several studies have supported rehabilitation in different surgical groups, but in lung cancer these are limited by lack of controlled Given the continued high morbidity after lung resection, the best comparisons.2 One of the important contributions of this work from type of and time for preoperative interventions must be explored Lai et al is providing support for the effectiveness of a 1-week and the patient profile that responds best to prehabilitation be inpatient program of rehabilitation on reducing the incidence of identified by using trials with greater statistical power. postoperative complications and postoperative length of hospital stay. However, there are several important points to consider when Provenance: Invited. Not peer reviewed. generalising these findings. Linda Denehy First, there was no description of interventions provided for the Melbourne School of Health Sciences, The University of Melbourne, control group nor was the rehabilitation described in a way that could be easily replicated. If the authors had followed the Template for Melbourne, Australia Intervention, Description and Replication (TIDieR) guidelines,3 this would have been improved. Second, it is important to consider that the References inpatient setting for this rehabilitation may have led to improved adherence. In many countries, patients undergoing lung resection are 1. Jones L, et al. Lancet Oncol. 2008;9:757–765. admitted on the day of surgery, with preoperative rehabilitation 2. Stefanelli F, et al. Eur J Cardiothorac Surg. 2013;44:260–265. conducted in outpatient or at-home settings. Third, the 95% CI for 3. Hoffman TC, et al. BMJ. 2014;348:g1687. 4. Granger C, et al. Chron Respir Dis. 2015;12:146. http://dx.doi.org/10.1016/j.jphys.2017.05.003 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 184 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers Intensive preoperative rehabilitation improves functional capacity and postoperative hospital length of stay in elderly patients with lung cancer Synopsis Summary of: Lai Y, Huang J, Yang M, Su J, Liu J, Che G. Seven-day function, 6-minute walk distance and quality of life (European Organiza- intensive preoperative rehabilitation for elderly patients with lung tion for Research and Treatment of Cancer QLQ-C30 and LC13_CN Version cancer: a randomized controlled trial. J Surg Res. 2017;209:30-36. 3) collected before and after the preoperative rehabilitation period. Results: The intervention group had a lower incidence of postoperative Question: In elderly patients undergoing thoracic surgery for non-small pulmonary complications (13.3% versus 36.7%, ARR = 0.23, 95% CI 0.01 to cell lung cancer, does a program of preoperative rehabilitation decrease 0.43). The intervention group had a shorter postoperative and total in- postoperative pulmonary complications? Design: Randomised, con- hospital length of stay (mean difference 3.8 days, 95% CI 1.0 to 6.6 and trolled trial with outcome assessor blinding. Setting: A single Chinese 3.7 days, 95% CI 0.8 to 6.6, respectively). The intervention group also hospital. Participants: Inclusion criteria were being aged 70 years with demonstrated a greater increase in 6-minute walk distance (mean dif- a definite diagnosis of primary non-small cell lung cancer and a willing- ference in change 19.2 m, 95% CI 2.1 to 36.3) and peak expiratory flow ness to undergo lobectomy via thoracic surgery. Exclusion criteria were: (mean difference 18.0 l/min, 95% CI 8.9 to 27.1) but no other differences in oxygen saturation < 90% during the 6-minute walk test, high risk of respiratory function tests or quality of life. Conclusion: A program of adverse events (myocardial infarction or cerebrovascular accident in past preoperative rehabilitation therapy reduced postoperative pulmonary year, unstable angina, aneurysm, haemoptysis, severe arrhythmia, mus- complications and hospital length of stay, and increased functional culoskeletal or mental disorder) or sub-resection/pneumonectomy. Ran- capacity in elderly thoracic surgery patients with non-small cell lung domisation of 60 participants allocated 30 to an intervention group and cancer. F[D_]2$1T[I 95% CIs for postoperative pulmonary complications, postopera- 30 to a control group. Interventions: Participants in the intervention tive and in-hospital length of stay calculated by the CAP EditorFD.T$01I[_]3 ] group received 7 days of rehabilitation, which comprised breathing exercises (performed on the ward three times/day) and aerobic endur- Provenance: Invited. Not peer reviewed. ance training via a recumbent cross trainer with resistance set by the patient (performed in a rehabilitation centre for 30 min/day). Partici- Elizabeth H Skinner pants in the control group received usual preoperative care. Outcome Department of Physiotherapy, Monash University, Australia measures: The primary outcome was the 30-day incidence of postopera- tive pulmonary complications. Secondary outcomes included postoper- http://dx.doi.org/10.1016/j.jphys.2017.05.004 ative and total in-hospital length of stay, D1FI$m_][T easures of resting lung © 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/). Commentary Surgical resection provides the best chance of cure for patients with absolute risk reduction in postoperative complications is wide, early stage lung cancer. Despite advances in surgical techniques, indicating that the true effect of this intervention on postoperative postoperative morbidity remains common. It is paramount to avoid complications may be substantially weaker or substantially stronger postoperative complications, as they can prolong admission times and than the absolute risk reduction estimate of 0.23. Finally, the secondary lead to poorer functional outcomes. In addition, lower preoperative outcome – mean difference in 6-minute walk distance (19 m, 95% CI exercise capacity is an established predictor of poor outcomes.1 2 to 36 m) – was not clinically significant when compared with the lung cancer minimum clinically important difference of 22 to 42 m.4 Several studies have supported rehabilitation in different surgical groups, but in lung cancer these are limited by lack of controlled Given the continued high morbidity after lung resection, the best comparisons.2 One of the important contributions of this work from type of and time for preoperative interventions must be explored Lai et al is providing support for the effectiveness of a 1-week and the patient profile that responds best to prehabilitation be inpatient program of rehabilitation on reducing the incidence of identified by using trials with greater statistical power. postoperative complications and postoperative length of hospital stay. However, there are several important points to consider when Provenance: Invited. Not peer reviewed. generalising these findings. Linda Denehy First, there was no description of interventions provided for the Melbourne School of Health Sciences, The University of Melbourne, control group nor was the rehabilitation described in a way that could be easily replicated. If the authors had followed the Template for Melbourne, Australia Intervention, Description and Replication (TIDieR) guidelines,3 this would have been improved. Second, it is important to consider that the References inpatient setting for this rehabilitation may have led to improved adherence. In many countries, patients undergoing lung resection are 1. Jones L, et al. Lancet Oncol. 2008;9:757–765. admitted on the day of surgery, with preoperative rehabilitation 2. Stefanelli F, et al. Eur J Cardiothorac Surg. 2013;44:260–265. conducted in outpatient or at-home settings. Third, the 95% CI for 3. Hoffman TC, et al. BMJ. 2014;348:g1687. 4. Granger C, et al. Chron Respir Dis. 2015;12:146. http://dx.doi.org/10.1016/j.jphys.2017.05.003 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 188 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Clinical Practice Guidelines Too Fit To Fracture Exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture Date of latest update: March 2014. Date of next update: by Osteoporosis Canada, the National Osteoporosis Foundation, and Unknown. Osteoporosis Australia’s Medical and Scientific Advisory Committee. Location: Osteoporosis International (Vol 25, No. 3, March 2014, pp. Patient group: Older adults with osteoporosis and no history 821-835); http://doi.org/10.1007/s00198-013-2523-2 of fracture; and older adults with a history of an osteoporotic vertebral fracture. Intended audience: Primary care clinicians, rheumatologists, Description: These recommendations were published as a physiotherapists, physical therapists and personal trainers. Additional 15-page journal article. They provide a consensus about exercise versions: Version one. Expert working group: An expert panel of recommendations for two target groups: older adults with osteoporosis researchers and clinicians was selected by the following criteria: and no history of fracture; and older adults with a history of an previous experience of guideline development; prior experience in osteoporotic vertebral fracture. An international expert panel used the conducting clinical trials in exercise and in people with osteoporosis or Grading of Recommendation Assessment, Development, and Evalua- vertebral fracture; or having clinical or anatomy/biomechanics tion (GRADE) approach to evaluate the quality of existing evidence and expertise related to exercise. Members of the panel were from generate recommendations. A number of reviews, meta-analyses, Australia, Canada, Finland and the United States, and included observational studies and systematic reviews from peer-reviewed stakeholders from Osteoporosis Canada. The expert panel had a wide journals were used to inform this project. A clear summary of the range of expertise, including: biomechanics, endocrinology, geriatrics, exercise recommendations is provided for the two target groups. The gerontology, internal medicine, kinesiology and physical therapy. Four recommendations are followed by a short summary of the evidence and patient advocates were chosen from the Canadian Osteoporosis Patient the rationale underlying it. The recommendations have most direct Network to inform outcomes on patient preference. Funded by: The relevance to physicians who prescribe exercise or professionals who University of Waterloo, Osteoporosis Canada, the Ontario Osteoporosis design exercise programs. Table 4 provides a comprehensive summary Strategy and Schlegel-University of Waterloo Research Institute for of the key recommendations. Tables 5 and 6 provide details of exercises Aging supported the project. Consultation with: Stakeholders from the used in clinical trials and exercise prescription details, respectively. Osteoporosis Canada Clinical Practice Guidelines committee, Canadian Osteoporosis Patient Network, National Osteoporosis Foundation Provenance: Invited. Not peer reviewed. Exercise and Rehabilitation Advisory Council, International Osteopo- rosis Foundation, Finnish Osteoporosis Association, Osteoporosis Isabel Rodrigues and Joy MacDermid Australia, and Canadian Physiotherapy Association were consulted McMaster University, Ontario, Canada for input about utility and clarity of the report. Approved by: Endorsed http://dx.doi.org/10.1016/j.jphys.2017.04.003 Knee osteoarthritis Surgical Management of Knee Osteoarthritis Evidence-Based Clinical Practice Guideline Date of latest update: December 2015. American Association of Hip and Knee Surgeons. Location: http:// www.orthoguidelines.org/topic?id=1019. Description: This guideline Patient group: Adult patients with suspected or confirmed osteoar- is intended to enhance musculoskeletal care for adult patients under- thritis of the knee. Intended audience: Primarily orthopaedic surgeons going surgical management of knee osteoarthritis. The guideline pro- and secondarily a variety of healthcare professionals, including phy- vides evidence-based recommendations that address 42 questions siotherapists. Additional versions: This is an updated version of a generated by the working group to define risk factors, types of anaes- previous guideline. The full 661-page version, including all summary thesia, surgical approaches, postoperative mobilisation/supervised tables and brief summaries of the key recommendations, is available. exercises that affect outcomes, including pain and complication rates. Expert working group: The group was chaired by an assistant clinical For physiotherapists, the most relevant points are recommendations professor of medicine and consisted of 13 members representing suggesting strong evidence for that rehabilitation initiated on the day of additional professional societies, including: four from the American arthroplasty reduces length of hospital stay, and that postoperative Academy of Orthopaedic Surgeons; three from the American Associa- continuous passive motion does not improve outcomes. This guideline tion of Hip and Knee Surgeons; and one from each of the Arthroscopy for surgical management of knee osteoarthritis is the most recent Association of North America, American Orthopaedic Society for Sports among a number of guidelines related to orthopaedic conditions that Medicine, Society of Military Orthopaedic Surgeons, American Physical have been funded by the American Academy of Orthopaedic Surgeons. Therapy Association, Society of Hospital Medicine, and American Soci- All of which are freely available at http://www.aaos.org/guidelines/? ety of Anesthesiologists. Funded by: The American Academy of Ortho- ssopc=1. paedic Surgeons. Consultation with: The professional associations represented and within the American Academy of Orthopaedic Sur- Provenance: Invited. Not peer reviewed. geons organisation. Approved by: The American Academy of Ortho- paedic Surgeons. Endorsed by: Arthroscopy Association of North Goris Nazari America, American College of Radiology, Society of Military Orthopae- Western University, Canada dic Surgeons, The Knee Society, American Geriatric Society, and http://dx.doi.org/10.1016/j.jphys.2017.04.004 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 168–174 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Limited interface between physiotherapy primary care and people with severe mental illness: a qualitative study Samantha Lee a, Flavie Waters b,c, Kathy Briffa a, Robyn E Fary a a School of Physiotherapy and Exercise Science, Curtin University; b Clinical Research Centre, Graylands Campus, North Metropolitan Health Service Mental Health; c School of Psychiatry and Clinical Neurosciences, University of Western Australia, Perth, Australia KEY WORDS ABSTRACT Physiotherapy Questions: How do mental health professionals perceive the role of physiotherapists in the care of people Physical therapy with severe and persistent mental illness, and what factors do they perceive as influencing access to Physical activity physiotherapy services? How do people with severe and persistent mental illness understand the Mental health potential role of physiotherapy in their healthcare, and what factors do they perceive as influencing Severe mental illness access to physiotherapy services? Design: Qualitative study. Participants: Twenty-four mental health professionals and 35 people with severe and persistent mental illness. Methods: Interview schedules were developed to explore participants’ understanding of physiotherapy, as well as barriers and enablers to service access. Focus groups and interviews were conducted for each group of participants. Transcripts were analysed using an inductive approach to derive key themes. Results: Both the mental health professionals and the people with severe and persistent mental illness expressed a limited understanding of the role and relevance of physiotherapy for physical health in mental healthcare. Common barriers to service access were cost, transport and lack of motivation. Likewise, enablers of reduced cost, provision of transport and education about physiotherapy to improve their understanding were identified. The health system structure and perceived lack of mental health knowledge by physiotherapists influenced referrals from mental health professionals. Consequently, education in mental health for physiotherapists and integration of the service within mental health were identified as potential enablers to physiotherapy access. Conclusion: Limited understanding about physiotherapy and its relevance to physical health in mental healthcare among mental health professionals and people with severe and persistent mental illness was found to be a key factor influencing service access. Limited physiotherapy presence and advocacy within mental health were also highlighted. There is a need for greater understanding about physiotherapy among stakeholders, and for physiotherapists to be well equipped with skills and knowledge in mental health to facilitate greater involvement. [Lee S, Waters F, Briffa K, Fary RE (2017) Limited interface between physiotherapy primary care and people with severe mental illness: a qualitative study. Journal of Physiotherapy 63: 168–174] © 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction in the World Health Organization’s 2014 slogan ‘no mental health without physical health as well’.4 Severe and persistent mental illness (SPMI) refers to mental health disorders that are associated with high levels of disability, A core principle of the World Health Organization’s initiative with profound impacts on personal, social and occupational has been promotion of a multidisciplinary approach to healthy functioning.1 These illnesses typically include disorders such as schizophrenia, schizoaffective disorders, bipolar disorder and lifestyle through increases in physical activity levels and improve- major depression.2 People with SPMI experience higher morbidity ment in diet.5,6 However, despite evidence supporting the benefits and mortality rates, with up to 20 years shorter life expectancy and use of physical activity in the treatment and management of than the general population.3 These morbidity and mortality rates are largely attributed to poor physical health, rather than a direct people with SPMI, physical activity levels in this population remain consequence of their mental illness.4 In view of this disparity in low.7 This discrepancy suggests a lack of translation of evidence physical health between the general population and those with SPMI, there has been a shift in attention towards improving into clinical practice, which has been aptly summarised by physical healthcare for people with SPMI. This shift is highlighted Bartels8(p10): ‘the greatest current barrier to increasing the life expectancy of persons with serious mental illness is no longer a knowledge gap – it is an implementation gap’. Healthcare providers play a crucial role in translating evidence into practice. However, a myriad of complex factors contribute to http://dx.doi.org/10.1016/j.jphys.2017.05.014 1836-9553/© 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Research 169 the present gap in implementation in mental healthcare. At a Box 1. Stimulus questions used with the mental health structural level, insufficient funding and lack of integration professionals. between physical and mental healthcare services4 mean inconsis- tent quality of healthcare and focus on physical Tw4$FD_[]I ellbeing. There is How are physical health issues of people with mental a lack of consensus between service providers over the role of illness addressed in your place of work? various healthcare professionals in the management of the physical health of people with SPMI, which thereby influences Do you think there is a role for physical activity and service provision.9,10]D[FT_7$I National physiotherapy bodies have provided exercise in the management of people with mental guidelines and recommendations regarding the potential for illness? physiotherapists to improve both the physical and mental health of people with mental illness.11,12 What is your understanding of the role of physiotherapists in the treatment and management of someone with Physiotherapists should be in a prime position to positively mental illness? influence the physical health of people with SPMI, through healthy lifestyle promotion and individualised physical activity pro- Have you ever referred a patient to a physiotherapist? grams,12 with support for physiotherapist-led physical activity If so, what prompted you to do this? programs among people with SPMI consistent across the What determined your choice of physiotherapist? literature.11–14 However, despite this compelling evidence sup- porting physiotherapy involvement in mental healthcare, anec- Do you think physiotherapy might benefit your clients and dotally, it appears that physiotherapists still play a minor and how so? unrecognised role as primary mental healthcare providers. This raises questions about why their involvement is limited. What would help in referring people with mental illness more frequently to community physiotherapists? The purpose of this study was to investigate factors influencing physiotherapy involvement in the treatment and management of Do you perceive any barriers in referring individuals with people with SPMI in Western Australia from the perspectives of mental illness to community physiotherapists? mental health professionals and people with SPMI. health professional. Volunteers were only included after verifica- Therefore, the research questions for this qualitative study tion of eligibility by their case manager or psychiatrist. Exclusion were: criteria were a current acute episode of psychosis or the inability to provide consent or communicate in English. 1. How do mental health professionals perceive the role of physiotherapists in the care of people with severe and persistent Data collection mental illness, and what factors do they perceive as influencing access to physiotherapy services? An interview protocol was developed for each category of participants, based on existing literature and the clinical experi- 2. How do people with severe and persistent mental illness ences of senior researchers (REF, KB and FW). Specifically, the understand the potential role of physiotherapy in their understanding of the role of physiotherapy in mental healthcare healthcare, and what factors do they perceive as influencing settings, and perceived barriers and enablers in accessing access to physiotherapy services? physiotherapy services for people with SPMI were explored. Method Prior to data collection, training was provided to the primary researcher (SL) who facilitated the focus groups. The training Study design included observations of focus groups involving people with SPMI. A sleep therapy researcher led the training, with advisory support This study used a qualitative approach employing both focus from an experienced mental health researcher and clinician (FW). group and individual interviews with mental health professionals and people with SPMI. A qualitative approach was chosen to allow Focus groups and individual interviews with mental health thorough exploration of participants’ views, concerns and beliefs on professionals were conducted at their place of work. The stimulus complex issues, which would not be attainable through quantita- questions used with the mental health professionals are presented tive means.15 Focus groups were chosen as the main method, due to in Box 1. Focus groups and individual interviews with people with added benefits of collective discussions and exchanging of views.16 SPMI were conducted at Curtin University, or their respective However, individual interviews were conducted if necessary to lodging or drop-in centre. The stimulus questions used with the accommodate participants’ schedules. This study was reported in participants with SPMI are presented in Box 2. Focus groups were accordance with the COREQ-32 criteria.17 scheduled to last for a maximum of 1 hour, whereas individual interviews were not scheduled for a maximum duration. Interviews Participants were audio-recorded and transcribed verbatim. Subsequently, each participant received a copy of the written transcript for verification. Mental health professionals were recruited from the North Appropriate amendments were made where requested. Metropolitan Health Service - Mental Health. This service provides public mental health care and treatment for approximately Participant characteristics were collected using paper ques- 1 million people in Perth, Western Australia.18 To be eligible, the tionnaires. For the mental health professionals, the recorded mental health professionals had to have an influence on referral characteristics were: gender, age, profession, area of work, processes or the authority to refer people with SPMI to experience, and prior referrals to physiotherapy. For the people physiotherapists. The mental health professionals were recruited with SPMI, the recorded characteristics were: diagnosis, duration via internal communication channels, including newsletters, of illness, previous experience with physiotherapy, and prior emails and word of mouth. referral for physiotherapy. People with SPMI were recruited from the community. Study Data collected during focus groups and individual interviews details were disseminated through community advertising and were analysed using an inductive approach to identify themes.19 flyers at drop-in centres and hostels. To be eligible, volunteers were Focus groups and data analysis continued until data saturation was required to be aged 18 to 65 years and have had a schizophrenia- achieved.19 Data saturation was defined as occurring when no new spectrum disorder or severe mood disorder diagnosed by a mental themes were identified in consecutive focus groups. Data analysis The characteristics of the participants were summarised using descriptive statistics calculated with commercial softwarea. Qualitative data were analysed by the primary researcher (SL) in
170 Lee et al: Physiotherapy for people with mental illness Box 2. Stimulus questions used with the participants with received physiotherapy referrals through a GP or mental health severe and persistent mental illness. team. In general, how would you consider your own general Focus groups health? What physical health problems do you have? A total of 10 and 13 focus group interviews were conducted with How do your physical health problems affect your day to mental health professionals and people with SPMI, respectively, day life? between February and June 2016. Of the mental health profes- sionals, 22 were interviewed in focus groups and two were Does your mental health team or case manager know that interviewed individually. Among the people with SPMI, 34 were you have physical health issues? interviewed in focus groups and one had an individual interview. The duration of focus groups and individual interviews ranged Have you tried, or do you want, to improve your physical from 20 to 60 minutes. health? What have you tried? Views of the mental health professionals Have you ever had a referral to a dietitian, physiotherapist, or occupational therapist? The themes and supporting quotes are summarised in Table 2. Thinking about physiotherapists, what do you think Theme 1: General lack of awareness and understanding regarding the physiotherapists do? role, scope of practice and relevance of physiotherapy in mental health How do you think physiotherapy can help in managing Although the benefits and importance of physical activity and your physical health? exercise for people with SPMI were recognised, few saw a role for physiotherapy in mental health. Physiotherapy was often per- Do you consider yourself to be physically active? ceived as relating only to specific injuries or musculoskeletal What sort of physical activity do you do and how much? problems. Reasons contributing to the current lack of understand- Thinking about your current lifestyle, how does physical ing were categorised into three subthemes (Table 2). activity fit in to your daily life or lifestyle? Subtheme 1.1: Lack of marketing of physiotherapy services within mental In your opinion, what might encourage you to consult or health services ask for referral to physiotherapists for your physical Mental health professionals spoke of the ‘lack of presence’ of health? physiotherapy, unlike other services such as occupational therapy In your opinion, what are some things that might prevent that actively promote and educate mental health professionals on you from seeing a physiotherapist? service options available for people with mental illness. consultation with two other researchers (REF and KB). An inductive Subtheme 1.2: Physiotherapy is a profession isolated from the mental analysis approach was used, with coding and categorising of the data health service obtained into main themes and subthemes until no new themes emerged.19 Themes were discussed amongst the research team to Physiotherapy was not perceived to be part of the treating reach consensus. multidisciplinary team. North Metropolitan Health Service – Mental Health offers physiotherapy services as part of inpatient rehabilita- Results tion, yet only five professionals were aware of this service. Participants Subtheme 1.3: Perceived lack of specialist mental health knowledge by physiotherapists A total of 24 mental health professionals and 35 people with SPMI were recruited for the study. The characteristics of each Mental health professionals also perceived that physiothera- group of participants are presented in Table 1. Among the mental pists lack the education and clinical experience that are specific to health professionals, four (17%) had referred a mental health patient to a physiotherapist. Among those with SPMI, 15 (43%) had had previous contact with a physiotherapist. One participant Table 1 Mental health People with severe and Characteristics of participants. professionals persistent mental illness Characteristic (n = 24) (n = 35) 21 (60) Gender, n male (%) 18 (75) 39 (9) Age (F]DTI$_5[yr), mean (SD) 44 (10) Primary area of professional practice, n (%) 23 (66) 11 (46) 4 (11) specialist nurse 5 (21) 4 (11) social worker 5 (21) 2 (6) occupational therapist 3 (13) 2 (6) other 17 (9) Current area of work, n (%) 22 (92) 15 (43) outpatient 1 (4) 1 (3) outpatient and inpatient 1 (4) research Clinical experience in mental health (yr), mean (SD) 19 (13) Has previously referred to physiotherapy, n (%) 4 (17) Schizophrenia spectrum disorder, n (%) schizophrenia schizoaffective disorder Severe mood disorder, n (%) bipolar disorder major depression other Duration of illness since diagnosis D[6FI]_($T yr), mean (SD) Previous experience with physiotherapy, n (%) Received referral by healthcare professional for physiotherapy, n (%)
Research 171 Table 2 Thematic responses of mental health professionals. Theme 1: Limited awareness and understanding of the role, scope of practice and relevance of physiotherapy in mental health Physiotherapy has always been one of those disciplines that I can’t . . . I can’t see, personally, that is compatible with mental health (M5) You would think about dieticians or you would think about occupational therapy . . . I would think of those professions before I would think that physiotherapy was a place to refer somebody. So I probably need educating about the role (of physiotherapy) (M9) Because if you’re thinking physical activity you’re not thinking physio, you’re thinking more groups . . . exercise (M16) Subtheme 1.1: Limited marketing of physiotherapy services within mental health services A lot of occupational therapists . . . work with GP clinics to get referrals and work with mental health clients . . . But I’ve not seen the same with physiotherapy (M21) Subtheme 1.2: Physiotherapy as a profession isolated from mental health services We’re all North Metro but no one here . . . has heard about the hospital’s physio program (M23) I think with physios in the hospital they sit in isolation so they’re not really part of the treating team per se . . . sometimes it looks from the outside it’s kind of well what can we do to keep the patients amused for an hour . . . (M24) Subtheme 1.3: Perceived lack of specialist mental health knowledge amongst physiotherapists It would have to be an education for the physiotherapists themselves because they would have to understand the medications, they’d have to understand the side-effects of the medications, they’d have to understand in depth a good history of the client, all aspects (M18) Theme 2: Structural barriers influencing referral process and uptake of services Subtheme 2.1: Limited funding capacity to address physical health problems The OTs used to run a few groups here that would address weight management and exercise programmes or that kind of thing, but now that funding’s gone it’s been . . . pushed over to the NGOs (M14) Walking groups, all those sort of things which now we’ve lost all the staff and the funding and the facilities to do (M12) Subtheme 2.2: Capacity and suitability of external services for physical health The GP remains in most instances . . . the coordinator of care for that person (M11) I suppose GPs might be out of their depths as well in terms of managing their complexities, multiple complexities (M13) In referring a person with mental issues to a GP... you’re actually asking them to do a whole lot more work which they don’t like in the mental health area because to do it properly requires a lot of input (M11) I think, they’re the hub, as they [GPs] should be, but I don’t think the communication going out from them is very good unless there’s a severe problem . . . communication flows one way a lot of the time (M20) Subtheme 2.3: Receptivity of external services But certainly, the lack of opportunities for mental health clients is phenomenal (M5) It becomes problematic in terms of the public system because there aren’t many around and the hospital itself isn’t very receptive to referrals that we might send (M4) Theme 3: Patient-specific barriers influencing referral processes Subtheme 3.1: High associated cost Money’s probably one of the largest barriers for our clients (M15) A large proportion are on disability support pensions so they’ve got quite a small income and therefore can’t afford a lot of medical services unless they are covered by Medicare or some form of funding (M6) Subtheme 3.2: Transport Physically getting there . . . we’ve got a lot of people who haven’t got transport, so that’s a problem as well (M11) Subtheme 3.3: Factors associated with the mental illness We work with quite complex people . . . it’s difficult then to make referrals on to other places until I guess things settle for them, or they never settle . . . So I could see it (physiotherapy) would be more appropriate for clients that are exiting the programme, a higher level of function, but not the clients that need that kind of service the most (M8) And even if we liaise with GPs . . . it has to be with the individual’s consent . . . A lot of our clients struggle with motivation (M9) We’ve got about a 30% DNA [did not attend] rate for appointments here . . . it’s difficult enough to get the client to come for an appointment regarding the medication never mind another appointment for something else (M16) Theme 4: Enablers to referrals to physiotherapy services Subtheme 4.1: Factors involving healthcare service providers We have very little awareness . . . that would be for the physiotherapist or physiotherapy association . . . to actually start creating an awareness campaign so that it would raise . . . our perspective of what they have to offer (M15) Very important that there is this person that understands a lot about clients that they’re working with, they don’t need to address any of that, but at least they could, you know, be comfortable with working with people . . . (M1) I’m wondering whether, from a physiotherapy perspective, if engaging the universities a bit more in coming in to do particular things, because we don’t see any physiotherapy students . . . (M19) I’d actually say we should have everything under the one roof, it’s a one stop shop (M20) Clear processes for referring people in to outpatient physiotherapy, as well, maybe having a list of who are the physiotherapists in the area, who would be interested engaging with our client group . . . (M21) Subtheme 4.2: Factors related to the individual with mental illness Money, transport, their understanding why they’ve been referred to . . . what they will benefit from it . . . (M19) mental health. They expressed the need for physiotherapists to be as non-governmental organisations, to assume responsibilities for equipped with adequate knowledge and skills about mental health physical health needs of these individuals. conditions and their treatment approaches, and identified the need for practical experience in a mental health setting as part of Some mental health professionals were unaware of inclusion of physiotherapy education. physiotherapy services in the Chronic Disease Management plan aimed at assisting people living with chronic conditions with their Theme 2: Structural barriers influencing referral process and uptake of complex health needs. This initiative allows the provision of five services allied health sessions per year as part of an individual’s general practitioner (GP) care plan. Mental health professionals who were Structural barriers were categorised into three subthemes. aware of physiotherapy’s inclusion raised questions regarding the adequacy of five sessions to manage the complex needs of these Subtheme 2.1: Limited funding influencing capacity to address physical individuals. health problems Subtheme 2.2: Capacity and suitability of external services for physical All mental health professionals were unequivocal in identifying health limited funding as a major structural barrier influencing their ability to manage the physical health of people with SPMI. This GPs were seen to be the ‘gatekeepers’ of physical healthcare for barrier has led to an increased reliance on external providers, such people with SPMI. In general, mental health professionals relied on
172 Lee et al: Physiotherapy for people with mental illness Table 3 Thematic interview responses of people with severe and persistent mental illness. Theme 1: Limited awareness and understanding of the role and scope of practice of physiotherapy They work on your joints and any particular problems that you might have with your joints and muscles (S22) They (physiotherapists) relax your muscles and make you do bendy exercises (S27) I don’t know what a physiotherapist is actually (S15) Theme 2: Barriers to accessing physiotherapy Subtheme 2.1: Transport Getting there and getting home and all that . . . Mainly transport. I don’t like catching trains and buses (S4) Subtheme 2.2: Cost of service Payment is a very, very big issue. I don’t . . . I think . . . I don’t know about anybody else, but I’m on disability support pension (S11) I can’t afford it, can’t afford physio. That’s probably one of the only reasons I don’t see one, it is the money side of things (S35) You know they give out 10 sessions throughout the year and then after that you’re expected to pay each time. And okay, there’s concession cards and things like that, but in saying that, not everybody’s got the money to go to physio (S29) Subtheme 2.3: Limited knowledge of service I actually don’t know what a physiotherapist can do for me (S3) Subtheme 2.4: Intrinsic factors Obviously the depression or whatever, you know there’s a lot of ‘I can’t be bothered’ and it just can come out of nowhere or that you just want to stay in bed and all that behaviour and stuff with the mental illnesses (S12) When I have it now they don’t do it the same anymore; it’s not as good as what it used to be . . . You’d get the physio and do exercises in the physio and then a massage after; after I got sore from exercise, and that helped a lot. And I told the woman there, I said, ‘If I do the exercise. If I don’t get a massage after I won’t do it.’ (S32) I don’t know if that’s true or not but I imagine they don’t take it holistically to find the real reason for the pain (S11) I think another thing with physio is it’s kind of like with all other problems that we’re facing it’s kind of like not the most essential thing in the world. And when it comes to having like smokes or physio, it’d be like, you know, hands-down smokes. Or you know, even getting to a physio because it’s kind of like - I don’t drive, so yeah (S12) Theme 3: Enablers to physiotherapy access Subtheme 3.1: Referrals from healthcare professional Through the staff and from the GP [would make it easier to access a physiotherapist] (S15) Subtheme 3.2: Education regarding physiotherapy It would be great if there was some information made available [about the role and benefits of physiotherapy] (S3) Subtheme 3.3: Social support They [mental health team] are very supportive . . . they give me a little bit of a push to go and look for the help that I need (S25) I find that the greatest support I had was from my family and friends (S30) Subtheme 3.4: Reduced cost of service access Maybe you can find a way where NDIS could subsidise some of the sessions. As opposed to going to your doctor maybe NDIS could give you À if it’s through mental health and getting physically better maybe they can subsidise some of the sessions for you. So instead of having five sessions you may have 15 because you only get so many a year (S30) GPs to manage the physical health of people with SPMI and Mental health professionals spoke of the lack of motivation assumed that it was the responsibility of the GPs to organise experienced by people with SPMI, which might be a symptom of services and relevant referrals pertaining to physical health. their mental illness, a medication side effect, or a consequence of However, mental health professionals also raised questions their physical co-morbidities. This issue had negative implications regarding the capacity of GPs to adequately manage both the for attendance at appointments with all healthcare services. physical and mental health of patients, given time constraints among other reasons. In addition, participants reported uncer- Theme 4: Enablers to referrals to physiotherapy services tainty regarding the outcome, due to poor communication Enablers to referrals were closely related to the barriers between services. mentioned above. Subtheme 2.3: Receptivity of external services Lastly, referral processes of mental health professionals were Subtheme 4.1: Factors involving healthcare service providers Mental health professionals expressed the need for education influenced by the willingness of external services to accept people with mental illnesses. Participants reported that uncertainty over about the role of physiotherapy in mental health. Increased the receptivity of various physiotherapy services to people with awareness and knowledge would be helpful in identifying mental illnesses limited their ability to make appropriate referrals. individuals who may be suitable for physiotherapy. Likewise, the mental health professionals identified the need for phy- Theme 3: Patient-specific barriers influencing the referral process siotherapists to be equipped with adequate skills and knowledge in In addition to structural barriers, factors specific to the mental health as another factor promoting referrals to physiother- apy. individual patient were mentioned. These barriers included cost of services, transport, severity of mental illness and motivation. Mental health professionals spoke of ways of reducing their uncertainty regarding their ability to refer patients directly to Subtheme 3.1: High associated cost physiotherapy. Clear and simple referral pathways were identified Participants noted that the most decisive factor influencing to be enablers for participants. Lastly, integration of physiotherapy into the mental health service was a proposed enabler to facilitate referral processes were the costs involved for the person with access to services by people with SPMI as part of primary mental mental illness. healthcare. Subtheme 3.2: Transport Subtheme 4.2: Factors related to the individual with mental illness Location and availability of transport to the service were also Mental health professionals cited factors specific to the identified as influential. individual patient that might facilitate referrals to physiotherapy. These included education regarding physiotherapy and informa- Subtheme 3.3: Factors associated with the mental illness tion regarding affordability of services. Education regarding the Participants also considered the individual’s mental health and benefits of physiotherapy was seen to enable the individual to make informed decisions. Heavily subsidised services and provi- suitability for a physical health program. They acknowledged that sion of transport were also identified as key enablers. despite their best intentions when organising services, choice of care and service uptake ultimately resided with the patient.
Research 173 People with SPMI There was unanimous agreement that education regarding the role of physiotherapy in benefiting physical health would Largely consistent with the findings from mental health encourage people with SPMI to access physiotherapy services. professionals, responses from participants with SPMI were classified into three main themes. Table 3 describes their themes Subtheme 3.3: Social support and provides supporting quotes. The participants with SPMI also identified encouragement from Theme 1: Limited awareness and understanding regarding the role and mental health professionals or family members as an enabler in scope of practice of physiotherapy encouraging access of physiotherapy service. The participants with SPMI expressed limited awareness about Subtheme 3.4: Reduced cost of service access the role of physiotherapy. Most were able to identify the role of The majority of participants thought that reducing the cost of physiotherapy, particularly in managing musculoskeletal pro- blems, but were limited in their understanding of physiotherapy physiotherapy would facilitate access. Provision of more sub- for their general physical or mental health. sidised physiotherapy sessions was also seen as a possible solution to the cost barrier, in addition to addressing issues regarding Theme 2: Barriers to accessing physiotherapy adequacy and effectiveness of limited subsidised sessions. In exploring barriers to physiotherapy access, the participants Discussion with SPMI identified factors similar to those highlighted by mental health professionals. It is believed that this study is the first to examine factors influencing physiotherapy involvement in mental healthcare from Subtheme 2.1: Transport the perspectives of mental health professionals and people with Location of and lack of transport to the physiotherapy service SPMI. Discussions at focus groups and interviews supported the existing impression that physiotherapists are under-utilised in were seen to be major barriers to accessing physiotherapy. The providing care for people with SPMI. A number of reasons for this issue of transport was especially salient for those people who situation emerged. preferred not to use public transport services. Both groups of participants reported a general lack of Subtheme 2.2: Cost of service understanding about physiotherapy and its relevance in mental The participants with SPMI were unanimous in identifying cost healthcare. This is consistent with recent literature in mental healthcare from other countries, which has reported a lack of as one of the greatest barriers to physiotherapy access. Despite the consideration for physiotherapy in managing physical co-morbid- provision of subsidised services, those participants with previous ities and in leading physical activity rehabilitation programs for physiotherapy experiences raised concerns regarding the effec- people with mental health conditions, despite the prominence of tiveness of the limited number of sessions covered. physiotherapists in this role in other areas of healthcare.11,14,20 The lack of understanding about physiotherapy not only serves as a Subtheme 2.3: Limited knowledge of service barrier to service access, but also highlights the potential for Limited awareness and understanding of the role of physio- greater advocacy and physiotherapy involvement in mental health. therapy further act as a barrier to physiotherapy access for people Mental health professionals identified structural barriers, such with SPMI. Participants expressed that they were less likely to as limited funding and lack of awareness of suitable services, along access physiotherapy services if they were uncertain about the role with uncertainty regarding their authority to refer to physiothera- and benefits of physiotherapy. py, as factors that limit referrals to physiotherapy. Moreover, they questioned the knowledge and skills of physiotherapists to manage Subtheme 2.4: Intrinsic factors complex presentations of people with SPMI. This is also consistent Similar to the mental health professionals, the participants with with a lack of available information and visibility of physiotherapy in mental health. SPMI expressed that healthcare access was fundamentally client driven. Limited motivation was highlighted as a key factor Limited funding in mental healthcare has led to an increased influencing access to healthcare services. This factor was often reliance on non-governmental organisations and GPs to address attributed to be a symptom of the individual’s mental illness that physical health issues of people with SPMI, and an emerging had effects on their access to healthcare services and, consequent- dichotomy between physical and mental health services.4,10 This ly, on their physical health. divide, combined with poor communication between service providers, has led to assumptions that referrals to appropriate The participants with SPMI also spoke of their perception services for physical healthcare for people with SPMI are the of the effectiveness of physiotherapy as a potential barrier to responsibilities of the treating GPs. However, it is uncertain service access. They reported being less likely to access whether GPs are aware of the role and relevance of physiotherapy physiotherapy services if previous experiences were perceived for people with SPMI. The poor understanding about the role of to be ineffective. Likewise, participants with no previous physiotherapy by people with SPMI would suggest not. This experiences with physiotherapy expressed reduced likelihood discontinuity in care and dichotomy of physical and mental health of accessing services if they envisaged physiotherapy to be needs is likely to hamper improvement in the physical health of ineffective. these individuals.21 Lastly, many of the participants with SPMI reported physical Enablers to physiotherapy access closely reflected the identified health and physiotherapy to be of a low priority compared to their barriers. Integration of services to enable access to physical health mental health and other needs. Consequently, they were less likely interventions as part of primary mental healthcare for people with to access such services because other issues such as time, being SPMI has been suggested both in Australia and internationally20,22 able to afford cigarettes and their mental health take precedence and would help to overcome the cost barrier. It would also help to over physical health. expose mental health professionals and patients alike to physio- therapy. Improved understanding about the role and benefits of Theme 3: Enablers to physiotherapy access physiotherapy has been recommended by the participants and The participants with SPMI spoke of four main enablers to previously as an essential step towards integrating physiotherapy within mental health services and, consequently, enabling greater accessing physiotherapy services. access.23 Subtheme 3.1: Referrals from healthcare professionals Participants said that they would be more likely to access physiotherapy services if they were referred by a mental health professional or their GP. Subtheme 3.2: Education regarding physiotherapy
174 Lee et al: Physiotherapy for people with mental illness Education and clinical experience in mental health has been References advocated to ensure that graduating physiotherapists are equipped with the necessary knowledge and skills to manage patients with 1. Australia Institute of Health and Welfare. Australia’s health 2014. Canberra: Australia co-morbid mental illness.11,23,24 This experience is relevant to all Institute of Health and Welfare; 2014. fields of physiotherapy, given the prevalence of mental illness.11,14,25 2. Alexandratos K, Barnett F, Thomas Y. The impact of exercise on the mental health The results of this study also emphasise the importance of and quality of life of people with severe mental illness: a critical review. Br J Occup social support in encouraging engagement with healthcare Ther. 2012;75:48–60. interventions among people with SPMI. Motivational impairments are characteristic among these individuals and negatively influ- 3. Arnoldy R, Curtis J, Samaras K. The effects of antipsychotic switching on diabetes in ence engagement with healthcare services.26 This parallels chronic schizophrenia. Diabet Med. 2013;31:16–19. findings documenting social support as a key extrinsic motivator in encouraging adherence to physical activity and smoking 4. Moore S, Shiers D, Daly B, Mitchell AJ, Gaughran F. Promoting physical health for cessation interventions.27,28 people with schizophrenia by reducing disparities in medical and dental care. Acta Psychiatr Scand. 2015;132:109–121. This study had several limitations. The generalisability of the results is limited by all participants having been recruited from 5. Bartels SJ, Pratt SI, Aschbrenner KA, Barre LK, Jue K, Wolfe RS, et al. Pragmatic the Perth metropolitan area. Second, individual interviews were replication trial of health promotion coaching for obesity in serious mental illness conducted to accommodate schedules of a few participants. Unlike and maintenance of outcomes. Am J Psychiatry. 2015;172:344–352. focus groups, exchange of ideas would not have been possible in individual interviews. However, information reported in individual 6. Green CA, Yarborough BJH, Leo MC, Yarborough MT, Stumbo SP, Janoff SL, et al. The interviews paralleled those discussed in focus groups, and data STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic saturation was achieved. Individual interviews could, however, medications: a randomised trial. Am J Psychiatry. 2015;172:71–81. also be considered as a strength of the study, as they provide participants more privacy to comment on issues they may have 7. Bredin SSD, Warburton DER, Lang DJ. The health benefits and challenges of exercise been reluctant to explore in a group setting. training in persons living with schizophrenia: a pilot study. Brain Sci. 2013;3: 821–848. There is potential for physiotherapists to be leaders in the management of physical co-morbidities and physical activity 8. Bartels SJ. Can behavioural health organisations change health behaviours? The interventions as members of a multidisciplinary mental health STRIDE study and lifestyle interventions for obesity in serious mental illness. Am J team. Of importance to physiotherapists is the limited under- Psychiatry. 2015;172:9–11. standing of the role and relevance of the profession in mental healthcare, and it being perceived as ineffective and lacking in 9. Barnes TRE, Paton C, Cavanagh MR, Hancock E, Taylor DM. A UK audit of screening mental health education by both groups of participants in this for metabolic side effects of antipsychotics in community patients. Schizophr Bull. study. Underpinning these factors is the reported absence of strong 2007;33:1397–1403. physiotherapy presence and advocacy within the mental health community. 10. Hyland B, Judd F, Davidson S, Jolley D, Hocking B. Case managers’ attitudes to the physical health of their patients. Aust N Z J Psychiatry. 2003;37:710–714. What is already known on this topic: People with severe and persistent mental illness (eg, schizophrenia, schizoaffec- 11. Pope C. Recovering mind and body: a framework for the role of physiotherapy in tive disorders, bipolar disorder and major depression) typically mental health and well-being. J Public Ment Health. 2009;8:36–39. have low physical activity levels and poor physical health. Personalised physical activity programs are beneficial in this 12. Stubbs B, Soundy A, Probst M, DeHert M, DeHerdt A, Vancampfort D. Understand- population. ing the role of physiotherapists in schizophrenia: an international perspective from What this study adds: There is a need for greater under- members of the International Organisation of Physical Therapists in Mental Health standing about how physiotherapy can contribute to physical (IOPTMH). J Ment Health. 2014;23:125–129. health in people with mental illness. Physiotherapy has limited presence and advocacy within the multidisciplinary mental 13. Stubbs B, Probst M, Soundy A, De Herdt A, De Hert M, Mitchell AJ, et al. healthcare team. Physiotherapists need to be well equipped Physiotherapists can help implement physical activity programmes in clinical with skills and knowledge in mental health to facilitate greater practice. Br J Psych. 2014;204:164. involvement. 14. Stubbs B, Soundy A, Probst M, Parker A, Skjaerven LH, Lundvik Gyllensten A, et al. Footnotes: a SPSS 23, IBM SPSS Inc, Chicago, USA. Addressing the disparity in physical health provision for people with schizophrenia: Ethics approval: Ethics approval for this study was obtained an important role for physiotherapists. Physiother. 2014;100:185–186. from North Metropolitan Health Service-Mental Health (NMHS- MH) Human Research Ethics Committee (reference number 15. Pope C, Mays N. Qualitative research: reaching the parts other methods cannot 09_2015) and the Human Research Ethics Committee at Curtin reach: an introduction to qualitative methods in health and health services University (reference number HR216/2015). All participants gave research. BMJ. 1995;311(6996):42–45. written informed consent before data collection began. Competing interests: Nil. 16. Bender DE, Ewbank D. The focus group as a tool for health research: issues in design Sources of support: This study was funded by the School of and analysis. Health Transit Rev. 1994;4:63–80. Physiotherapy and Exercise Science at Curtin University. Acknowledgements: The authors would like to acknowledge Ms 17. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research Vivian Chiu for her guidance in focus groups. (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. Provenance: Not invited. Peer reviewed. 2007;19:349–357. Correspondence: Dr Robyn Fary, School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia. Email: 18. Department of Health. North Metropolitan Health Service – Mental Health. www. [email protected] nmahsmh.health.wa.gov.au. Published 2016. Accessed August 27, 2016. 19. Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs. 2007;62: 107–115. 20. Vera-Garcia E, Mayoral-Cleries F, Vancampfort D, Stubbs B, Cuesta-Vargas AI. A systematic review of the benefits of physical therapy within a multidisciplinary care approach for people with schizophrenia: an update. Psychiatry Res. 2015; 229:823–839. 21. Baxter AJ, Harris MG, Khatib Y, Brugha TS, Bien H, Bhui K, et al. Reducing excess mortality due to chronic disease in people with severe mental illness: meta-review of health interventions. Br J Psych. 2016;208:322–329. 22. Vancampfort D, DeHert M, Skjerven LH, Gyllensten AL, Parker A, Mulders N, et al. International Organisation of Physical Therapy in Mental Health consensus on physical activity within multidisciplinary rehabilitation programmes for minimiz- ing cardio-metabolic risk in patients with schizophrenia. Disabil Rehabil. 2012;34: 1–12. 23. Vancampfort D, Rosenbaum S, Probst M, Connaughton J, du Plessis C, Yamamoto T, et al. Top 10 research questions to promote physical activity in bipolar disorders: a consensus statement from the International Organisation of Physical Therapists in Mental Health. J Affect Disord. 2016;195:82–87. 24. Connaughton J, Gibson W. Physiotherapy students’ attitudes toward psychiatry and mental health: a cross-sectional study. Physiother Can. 2016;68:172–178. 25. Probst M, Peuskens J. Attitudes of Flemish physiotherapy students towards mental health and psychiatry. Physiother. 2010;96:44–51. 26. Farholm A, Sørensen M. Motivation for physical activity and exercise in severe mental illness: a systematic review of intervention studies. Int J Ment Health Nurs. 2016;25:194–205. 27. Knowles S, Planner C, Bradshaw T, Peckham E, Man MS, Gillbody S. Making the journey with me: a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness. BMC Psychiatry. 2016;16:193–201. 28. Soundy A, Freeman P, Stubbs B, Probst M, Vancampfort D. The value of social support to encourage people with schizophrenia to engage in physical activity: an international insight from specialist mental health physiotherapists. J Ment Health. 2014;23:256–260.
Journal of Physiotherapy 63 (2017) 186 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Clinimetrics Measuring two-point discrimination threshold with a caliper Summary Description: The two-point discrimination (TPD) test is a quantita- the points is then increased (ascending run) or decreased (descending tive assessment of tactile acuity. The TPD threshold was first defined by run) until the TPD threshold is reached. Catch trials are often used to Webster in 1934 as ‘the distance between compass points necessary to feel two contacts’.1 Increased TPD threshold reflects decreased tactile remove chance of the patient guessing their response. Heterogeneity acuity.2 The TPD test originated, and continues to be extensively used in procedures exists, including: the initial starting position of the two clinically, to both evaluate and monitor patient recovery following caliper points; the increments that the caliper points are changed peripheral nerve injuries and polyneuropathies.3,4 For areas of dense between trials; the number of ascending and descending trials; and sensory innervation (1 to 15 mm), handheld tools such as a discriminator5 or paperclip6 are used. Whilst TPD is dependent on the criteria for determining TPD threshold. Normative data are available for the face, neck, trunk and limbs.7,10–12 Reliability, validity peripheral innervation density and intact neural pathways, it is also and responsiveness: No systematic review on the measurement believed to be dependent on response profiles of central somatosensory function.2 Specifically, TPD is thought to represent the response profile properties of the caliper to measure TPD threshold has been published. of primary somatosensory cortex (S1) neurons, offering a clinical Data from individual studies describing the intra-rater reliability of the signature of S1 representation. The TPD test has therefore been caliper suggest that it is good for areas of the neck (ICC 0.79), hand (ICC 0.82), foot (ICC 0.86) and back (ICC 0.72 to 0.81),7,13 with excellent recommended as a simple clinical tool to measure the magnitude of 4-month test-retest reliability in the back (ICC 0.90).14 The inter-rater the S1 representations.2 The mechanical or digital sliding caliper has reliability has been shown to be good for the neck (ICC 0.81) and foot (ICC been suggested as a suitable instrument to measure TPD in 0.78), and moderate for the hand (ICC 0.62) and back (ICC 0.56 to 0.66).7,13 The validity of TPD is controversial. The traditional use of TPD as assessment of regions of lower tactile acuity such the limbs and a measure of tactile acuity alone has been questioned,15 with some trunk.7 The hardware-style caliper is calibrated to measure from 1 to authors reporting seemingly spuriously good performance at small 150 mm and can be purchased from AUD$15.7 Instructions and tip separations and unexplained variations between subjects and scoring: Although there is no standard procedure for testing TPD with studies.16,17 Currently, TPD is thought to be a measure of both tactile a caliper,3,8 typically during the test the patient is comfortably acuity and provide a clinical signature of cortical organisation.18 Although patterns of cortical reorganisation in S1 have been reported positioned so that the area of interest is supported and out of direct to be correlated with TPD tactile discrimination,19 no formal TPD view. The clinician applies the caliper perpendicular to the patient’s validation studies have been published. The responsiveness of a caliper skin with sufficient pressure to ‘blanch’ the skin.9 The patient is asked to respond whether they feel one or two points. The distance between to measure TPD has not been reported. Commentary Measuring TPD with a caliper is a simple method of evaluating test13 have also been developed and their measurement properties tactile acuity. The assessment is quick (3 minutes), reliable and requires should be further investigated. minimal training: 30 minutes of clinician training has been shown to be sufficient to produce reliable measures.7 Some caution is required Aidan G Cashina,b and James H McAuleya,b when interpreting TPD measurements performed by different clin- aNeuroscience Research Australia (NeuRA) icians/researchers due to lower inter-rater reliability, particularly for the hand or back. In light of uncertainty associated with the bPrince of Wales Clinical School, University of New South Wales, responsiveness and validity of TPD, it is likely to be best used as part Sydney, Australia of a comprehensive clinical assessment rather than as a tool to monitor patient progress. Limitations: The lack of a standard procedure for References measuring TPD with a caliper may limit the ability to compare findings between studies or clinics, and introduces difficulties comparing to 1. Weber EH, et al. Erlbaum (UK) Taylor & Francis; 1996. http://trove.nla.gov.au/ normative data. Large variability in TPD measurements has been version/26701992 reported between subjects and across multiple body sites, suggesting random error.8,14 Therefore, although TPD may be reliable within a 2. Lotze M, et al. Curr Rheumatol Reports Curr Med Gr LLC ISSN. 2007;9:488–496. person, it may lack precision.7 As such, large changes are required in 3. Lundborg G, et al. J Hand Surg Am. 2004;29:418–422. TPD measurements to be confident that any measured change is true 4. Jerosch-Herold C. J Hand Surg Am. 2005;30:252–264. and not attributed to variability in the measure (ie, chance). Random 5. Dellon AL, et al. J Hand Surg Am. 1987;12:693–696. error associated with TPD measurement has been well documented, 6. Finnell JT, et al. Acad Emerg Med. 2004;11:710–714. describing both within-patient factors (ie, age, skin-contact-related 7. Catley MJ, et al. Rheumatol (United Kingdom). 2013;52:1454–1461. factors, patient cooperation and fatigue) and clinician factors (ie, 8. Catley MJ, et al. J Pain. 2014;15:985–1000. assessment protocol and methods, instrument, skill and assessor 9. Moberg E. Scand J Rehabil Med. 1990;22:127–134. bias).7,13,17 10. Nolan MF. Phys Ther. 1985;65:181–185. 11. Wand BM, et al. Man Ther. 2014;19:504–507. A systematic review of validity and reliability of the caliper to 12. Stanton TR, et al. Rheumatology. 2013;52:1509–1519. measure TPD is needed to more comprehensively evaluate its 13. Adamczyk W, et al. Man Ther. 2016;22:220–226. measurement properties. Alternate tools such as the point-to-point 14. Marcuzzi A, et al. Pain. 2017;1. 15. Jerosch-Herold C. J Hand Surg Br Eur Vol. 2005;30:252–264. 16. Craig JC, et al. Curr Dir Psychol Sci. 2000;9:29–32. 17. Tong J, et al. Front Hum Neurosci. 2013;7:579. 18. Moseley GL, et al. Neurorehabil Neural Repair. 2012;26:646–652. 19. Pleger B, et al. Neuroimage. 2006;32:503–510. http://dx.doi.org/10.1016/j.jphys.2017.04.005 1836-9553/© 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 185 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers Patients with uncomplicated total knee arthroplasty may not benefit from referral to inpatient rehabilitation Synopsis Summary of: Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, content of the home-based program included aerobic, functional Wright R, et al. Effect of inpatient rehabilitation vs a monitored home- and knee-specific exercises. Outcome measures: The primary out- based program on mobility in patients with total knee arthroplasty: come was walking distance at 26 weeks measured using the the HIHO randomized clinical trial. JAMA. $F]DI[T_0129 017;317:1037–1046. 6-minute walk test. Secondary outcome measures included the Knee Injury and Osteoarthritis Outcome score, knee flexion range, the Question: Does inpatient rehabilitation improve mobility, function EuroQol quality of life questionnaire, the Oxford Knee Score, a 15-m and quality of life after total knee arthroplasty? Design: Random- walk test, and patient satisfaction. Results: A total of 159 participants ised, controlled trial with concealed allocation and blinded outcome completed the study. At 26 weeks, there was no between-group assessment. Setting: Two public hospitals in Sydney, Australia. difference in distance walked in the 6-minute walk test (MD –1 m, Participants: Key inclusion criteria were: undergoing a primary, 95% CI –26 to 24). At week 10, the inpatient rehabilitation group was unilateral total knee arthroplasty for osteoarthritis, being aged more satisfied with rehabilitation than the home-based group (MD > 40 years, and being ready for discharge from the acute hospital 9 units out of 100, 95% CI 3 to 15). There were no between-group at day 5 after surgery. Key exclusion criteria included: having a differences for any other secondary outcomes at 10, 26 or 52 weeks. requirement to be discharged to inpatient rehabilitation due to lack Conclusion: A period of inpatient rehabilitation after total knee of social support, having major coexisting physical impairments, arthroplasty for patients who are able to go home did not lead to and having a complication after surgery. Randomisation of 165 improved mobility, function or quality of life when compared to a participants allocated 81 to inpatient rehabilitation and 84 to the monitored home-based program. home-based group. Interventions: The inpatient rehabilitation group received twice-daily supervised sessions of physiotherapy Provenance: Invited. Not peer reviewed. and class-based exercises for 10 days followed by an 8-week home-based program. The inpatient rehabilitation sessions included Nicholas Taylor aerobic, functional, and knee-specific exercises, as well as gait Section Editor, Journal of Physiotherapy training. The home-based group attended up to three group-based sessions in outpatient physiotherapy commencing at about 2 weeks, http://dx.doi.org/10.1016/j.jphys.2017.05.006 where the home program was practised and then revised. The Commentary Although the authors planned a costT$FD_I]5[3-benefit analysis, this was predicated on demonstrating a superior outcome for participants Although total knee arthroplasty is both an effective and cost- in the intensive inpatient program. Based on the null finding with effective procedure for treating advanced knee osteoarthritis, respect to functional recovery, the authors have presumed that the projected rises in disease burden1 as well as increases in the total home program represents a cost-effective option for post total costs of surgery2 raise concerns about the sustainability of current knee arthroplasty rehabilitation; however, this remains untested. practices. This well-designed study that was conducted in a public While this would seem a logical presumption, criteria are more hospital setting is important, as it provides evidence that for stringent for discharge directly home than for rehabilitation after selected patients undergoing total knee arthroplasty, intensive total knee arthroplasty, and include the need for carer support. inpatient rehabilitation is not superior compared to a structured Discharge directly home after total knee arthroplasty may well be home-based program, with respect to longer-term functional at the expense of a longer acute length of stay than for those recovery. transferred to rehabilitation. Therefore, a robust cost-benefit analysis would make an important contribution to the evidence The challenge now is to evaluate whether such a structured base in support of the study findings. home-based program can be delivered in the private sector, given that, as the authors note, approximately 40% of private sector Michelle Dowsey patients are transferred to inpatient rehabilitation (nearly double Department of Surgery St. Vincent’s Hospital, The University of that of public sector patients) and that the decision to discharge home via inpatient rehabilitation after total knee arthroplasty is Melbourne, Australia perceived as one of patient personal preference amongst this group. Important next steps are to better understand why References participant-rated satisfaction favoured inpatient rehabilitation following total knee arthroplasty, and to evaluate the cost- 1. Vos T, et al. Lancet. 2016;380(9859):2163–2196. effectiveness of minimal intervention rehabilitation compared 2. Yelin E, Cisternas M. Bone and Joint Initiative USA; 2013. with inpatient rehabilitation. http://dx.doi.org/10.1016/j.jphys.2017.05.005 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 185 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers Patients with uncomplicated total knee arthroplasty may not benefit from referral to inpatient rehabilitation Synopsis Summary of: Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, content of the home-based program included aerobic, functional Wright R, et al. Effect of inpatient rehabilitation vs a monitored home- and knee-specific exercises. Outcome measures: The primary out- based program on mobility in patients with total knee arthroplasty: come was walking distance at 26 weeks measured using the the HIHO randomized clinical trial. JAMA. $F]DI[T_0129 017;317:1037–1046. 6-minute walk test. Secondary outcome measures included the Knee Injury and Osteoarthritis Outcome score, knee flexion range, the Question: Does inpatient rehabilitation improve mobility, function EuroQol quality of life questionnaire, the Oxford Knee Score, a 15-m and quality of life after total knee arthroplasty? Design: Random- walk test, and patient satisfaction. Results: A total of 159 participants ised, controlled trial with concealed allocation and blinded outcome completed the study. At 26 weeks, there was no between-group assessment. Setting: Two public hospitals in Sydney, Australia. difference in distance walked in the 6-minute walk test (MD –1 m, Participants: Key inclusion criteria were: undergoing a primary, 95% CI –26 to 24). At week 10, the inpatient rehabilitation group was unilateral total knee arthroplasty for osteoarthritis, being aged more satisfied with rehabilitation than the home-based group (MD > 40 years, and being ready for discharge from the acute hospital 9 units out of 100, 95% CI 3 to 15). There were no between-group at day 5 after surgery. Key exclusion criteria included: having a differences for any other secondary outcomes at 10, 26 or 52 weeks. requirement to be discharged to inpatient rehabilitation due to lack Conclusion: A period of inpatient rehabilitation after total knee of social support, having major coexisting physical impairments, arthroplasty for patients who are able to go home did not lead to and having a complication after surgery. Randomisation of 165 improved mobility, function or quality of life when compared to a participants allocated 81 to inpatient rehabilitation and 84 to the monitored home-based program. home-based group. Interventions: The inpatient rehabilitation group received twice-daily supervised sessions of physiotherapy Provenance: Invited. Not peer reviewed. and class-based exercises for 10 days followed by an 8-week home-based program. The inpatient rehabilitation sessions included Nicholas Taylor aerobic, functional, and knee-specific exercises, as well as gait Section Editor, Journal of Physiotherapy training. The home-based group attended up to three group-based sessions in outpatient physiotherapy commencing at about 2 weeks, http://dx.doi.org/10.1016/j.jphys.2017.05.006 where the home program was practised and then revised. The Commentary Although the authors planned a costT$FD_I]5[3-benefit analysis, this was predicated on demonstrating a superior outcome for participants Although total knee arthroplasty is both an effective and cost- in the intensive inpatient program. Based on the null finding with effective procedure for treating advanced knee osteoarthritis, respect to functional recovery, the authors have presumed that the projected rises in disease burden1 as well as increases in the total home program represents a cost-effective option for post total costs of surgery2 raise concerns about the sustainability of current knee arthroplasty rehabilitation; however, this remains untested. practices. This well-designed study that was conducted in a public While this would seem a logical presumption, criteria are more hospital setting is important, as it provides evidence that for stringent for discharge directly home than for rehabilitation after selected patients undergoing total knee arthroplasty, intensive total knee arthroplasty, and include the need for carer support. inpatient rehabilitation is not superior compared to a structured Discharge directly home after total knee arthroplasty may well be home-based program, with respect to longer-term functional at the expense of a longer acute length of stay than for those recovery. transferred to rehabilitation. Therefore, a robust cost-benefit analysis would make an important contribution to the evidence The challenge now is to evaluate whether such a structured base in support of the study findings. home-based program can be delivered in the private sector, given that, as the authors note, approximately 40% of private sector Michelle Dowsey patients are transferred to inpatient rehabilitation (nearly double Department of Surgery St. Vincent’s Hospital, The University of that of public sector patients) and that the decision to discharge home via inpatient rehabilitation after total knee arthroplasty is Melbourne, Australia perceived as one of patient personal preference amongst this group. Important next steps are to better understand why References participant-rated satisfaction favoured inpatient rehabilitation following total knee arthroplasty, and to evaluate the cost- 1. Vos T, et al. Lancet. 2016;380(9859):2163–2196. effectiveness of minimal intervention rehabilitation compared 2. Yelin E, Cisternas M. Bone and Joint Initiative USA; 2013. with inpatient rehabilitation. http://dx.doi.org/10.1016/j.jphys.2017.05.005 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 63 (2017) 175–181 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research People attending pulmonary rehabilitation demonstrate a substantial engagement with technology and willingness to use telerehabilitation: a survey Zachariah Seidman a,$D]FIT_7[ Renae McNamara b, Sally Wootton c, Regina Leung d, Lissa Spencer e, Marita Dale f, Sarah Dennis a, Zoe McKeough a a Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney; b Departments of Respiratory and Sleep Medicine, and Physiotherapy, Prince of Wales Hospital; c Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District; d Department of Thoracic Medicine, Concord Repatriation General Hospital; e Department of Physiotherapy, Royal Prince Alfred Hospital; f Department of Physiotherapy, St Vincent’s Hospital, Sydney, Australia KEY WORDS ABSTRACT Telerehabilitation Questions: What is the level of technology engagement by people attending pulmonary rehabilitation? Surveys and questionnaires Are participant demographics and level of technology engagement associated with willingness to use Technology telerehabilitation? Design: A cross-sectional, multicentre study involving quantitative survey analysis. Pulmonary Participants: Convenience sample of people with chronic respiratory disease attending a pulmonary Physical therapy rehabilitation program, maintenance exercise class or support group. Outcome measures: The survey assessed the participants’ level of technology engagement (access to and use of devices), self-rated skill competence, access to online health information and willingness to use telerehabilitation. Results: Among the 254 people who were invited, all agreed to complete the survey (100% response rate). Among these 254 respondents, 41% were male, the mean age was 73 years (SD 10), and the mean forced expiratory volume in 1 second (FEV1) was 59% predicted (SD 23). Ninety-two percent (n = 233) of participants accessed at least one technological device, of whom 85% (n = 198) reported regularly using mobile phones and 70% (n = 164) regularly used a computer or tablet. Fifty-seven percent (n = 144) of participants self-rated their technology skill competence as good and 60% (n = 153) of all participants were willing to use telerehabilitation. The multivariate regression model found regular computer use (OR 3.14, 95% CI 1.72 to 5.71) and regular mobile phone use (OR 2.83, 95% CI 1.32 to 6.09) were most associated with a willingness to use telerehabilitation. Conclusion: People attending metropolitan pulmonary rehabilitation, maintenance exercise classes and support groups had substantial technology engagement, with high device access and use, and good self-rated technology competence. The majority of participants were willing to use telerehabilitation, especially if they were regular users of technology devices. [Seidman Z, McNamara R, Wootton S, Leung R, Spencer L, Dale M, Dennis S, McKeough Z (2017) People attending pulmonary rehabilitation demonstrate a substantial engagement with technology and willingness to use telerehabilitation: a survey. Journal of Physiotherapy 63: 175–181] © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction access to services, whilst reducing barriers associated with For people with chronic respiratory disease, pulmonary attending centre-based programs for people with chronic respira- rehabilitation has been shown to be effective in reducing dyspnoea and improving quality of life and functional exercise capacity.12D]FT[I_$ tory disease. However, the rates of attendance in Australia are poor, with <1% of people with moderate-to-severe chronic obstructive pulmonary Telehealth is an evolving healthcare delivery system that disease (COPD) engaging in pulmonary rehabilitation.2 Further- more, 8 to 50% of people referred to pulmonary rehabilitation do employs various technology modalities to overcome the barriers not attend, and 10 to 32% of people who start do not complete the program.3 This can be attributed to the many barriers that exist, that people face in accessing services. Pulmonary telerehabilita- which reduce a person’s ability to access pulmonary rehabilitation programs. These barriers include travel time and the costs involved tion is defined as the delivery of pulmonary rehabilitation services in attending the program site, as well as fatigue, inconvenience and via telecommunication and videoconference technologies.4 There disruption caused to daily activities.3$DT_3F[2I] Novel strategies of pulmo- nary rehabilitation delivery such as telerehabilitation are of are various models of pulmonary telerehabilitation, including: interest because they may increase convenient and equitable in-home videoconferencing,5–8 videoconferencing from a central centre to a satellite centre,9 mobile phone-based exercise programs,10 a combination of videoconferencing and telephone support,11 and web-based self-monitoring.12–14 Two systematic reviews evaluating telerehabilitation programs for people with cardiopulmonary disease concluded that telerehabilitation pro- grams provide similar improvements in exercise capacity as centre- based programs15 and have higher compliance rates.16 A recent http://dx.doi.org/10.1016/j.jphys.2017.05.010 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
176 Seidman et al: Technology engagement in pulmonary rehabilitation study, not included in these systematic reviews, was the first ran- were made based on feedback to enhance understanding and domised, controlled trial of an 8-week in-home videoconferencing comprehension of the questions. The final survey had a Flesch telerehabilitation exercise program compared with usual medical reading ease score of 70 (easy to read).22TD4[]F_2I$ The survey, the results for care in people with COPD. The study found that the telerehabilita- each question, and an indication for how some variables were tion exercise group had statistically significant improvements in combined for statistical analysis are presented in Appendix 1 (See endurance exercise capacity and self-efficacy with high satisfaction eAddenda for Appendix 1). and completion rates compared to the usual care group.5,17 Sample size Engaging with pulmonary telerehabilitation using videocon- ferencing requires patients to have access to and use technological An online survey sample size calculator was used to determine devices with an internet connection. In a COPD telemedicine trial, an adequate sample size for this study. The overall COPD it was found that technical concerns (eg, not wanting a computer in population in Australia is approximately 1.5 million people.23 A the home) and personal concerns (eg, feeling too old to adopt new confidence level of 95% with a margin of error (confidence interval) technology) were barriers to people using telerehabilitation.18 of 7% was chosen, and resulted in a sample size of 196 participants. Previous research into the use of technology in other chronic Assuming a response rate of 80%, 245 people were needed for the diseases, including diabetes,19 lung cancer20 and chronic cardio- survey. pulmonary conditions,21 have reported mixed results in the access and use of technology. In a diabetic population, the ‘willingness’ to Data analysis use telehealth technology was significantly associated with the uptake of telerehabilitation.19 To date, no research has investigated ‘Technology engagers’ were defined as participants with the access and use of technology, the willingness to use technology personal access to and use of at least one technological device for disease management, and the factors relating to accessing in their home. ‘Technology non-engagers’ were defined as health information online in the pulmonary rehabilitation participants with no access to or use of any technological device. population. Differences between technology engagers and non-engagers were assessed using independent sample t-tests and cross-tabs with Therefore, the research questions for this cross-sectional, multi- Fisher’s Exact p-value significance set at 0.05. Univariate cross-tabs centre survey were: were calculated to determine the unadjusted associations between the variables of age, gender, education and number of co- 1. What is the level of technology engagement by people attending morbidities to the primary outcomes of the participants’ access pulmonary rehabilitation, including the access to, use of and and use of devices and their self-reported skill competence. The self-reported level of competence in using technology devices? univariate cross-tabs were repeated to determine the independent associations of the variables and primary outcomes to the 2. Are a participant’s demographics and factors related to secondary outcomes of the participants’ willingness to use technology engagement associated with the likelihood of telerehabilitation and research health information online. If more researching health information online and FID$5[2]_Twillingness to use than two significant univariate associations were established for a telerehabilitation? given outcome, a multivariate regression analysis assessed them together for confounding factors. The threshold for significance in Methods the multivariate analysis was p < 0.05. A regression model was then created with the remaining significant associations to Study design and participants determine which variables were most suggestive of having high device access with regular use, good self-rated computer skill A cross-sectional, TDm]F_2$[I ulticentre survey was conducted between competence, researching health information online, and being December 2015 and April 2016. A convenience sample was used willing to use telerehabilitation. The descriptive and quantitative whereby people attending one of nine Australian metropolitan analysis was performed using commercial softwarea for partici- pulmonary rehabilitation programs, maintenance exercise classes pant characteristics and outcome data. or patient support groups, and with a chronic respiratory or cardiac disease were eligible to participate in the study. People were One researcher (ZS) manually coded the responses to the excluded if they could not understand or communicate using optional open-ended question in the survey into categories of the spoken English. To avoid non-response bias, investigators were participants’ willingness or not to use telerehabilitation. The coded permitted to read the survey to anyone requiring assistance or categories were organised into themes through discussion unable to read English, but able to converse in English. Details of between two members of the research team (ZS, ZM). the participants’ medical history, lung function test results and demographic details were obtained with consent from their Results medical records. Survey Participants A purpose-designed survey was developed; it contained In total, 254 people were screened and invited to participate in 26 questions with pre-determined responses regarding the the study, all of whom completed the survey (100% response rate) participants’ demographics, engagement with technology, self- (Figure 1). The primary respiratory diagnoses of these participants rated computer and internet skill competence, and views of were: COPD (63%, n = 161), bronchiectasis (11%, n = 29), asthma technology use in healthcare. The survey questions asked about (9%, n = 23), pulmonary fibrosis (4%, n = 10), shortness of breath access to technological devices, the frequency and reasons for (3%, n = 8) and other respiratory conditions (9%, n = 23). Of the using them, and the willingness to use telerehabilitation. Tele- 254 participants, 92% (n = 233) were classified as technology rehabilitation was defined as the ability to interact (speak, listen engagers. Participant characteristics are shown in Table 1. The and see) with the physiotherapists in real time on the device’s majority of participants had moderate airflow limitation, spoke screen, using videoconferencing software whilst exercising at English as their primary language, were retired, and had a high home. One question allowed participants to express in writing proportion of comorbidities. Technology non-engagers were their motivations for, or against, the use of telerehabilitation. The significantly older (p < 0.001) than technology engagers and had survey was pilot tested on a group of ten pulmonary rehabilitation a greater proportion of people who had completed a lower level of attendants at one metropolitan hospital. Minor wording changes education (p = 0.039).
ure_1)TD$F[(i]GIg Research 177 254 participants enrolled p-value c from pulmonary < 0.001 rehabilitation sites through 0.005 a letter of invitation to 1.000 participate 0.293 0.756 St Vincent’s Manly Terry Hills Ryde Hornsby 0.039 Hospital Hospital Hospital Hospital Hospital 0.776 0.489 n = 23 n=9 n=9 n = 17 n = 20 0.960 (9%) (4%) (4%) (7%) (8%) 0.291 < 0.001 Prince of Concord Royal Prince Royal North < 0.001 Wales Repatriation Alfred Shore Hospital Hospital Hospital 0.094 General 0.485 n = 90 Hospital n = 30 n = 21 0.749 0.816 (35%) n = 35 (12%) (8%) (14%) 100% response rate 254 surveys analysed quantitatively Figure 1. Selection of pulmonary rehabilitation hospital service providers and participants for the study. Table 1 Characteristics of participants. Characteristic All Technology Technology participants engagers a non-engagers b (n = 254) (n = 233) (n = 21) Age (yr), mean (SD) 73 (10) 73 (10) 81 (6) Age 70 years, n (%) 159 (63) 140 (60) 19 (90) Gender, n male (%) 104 (41) 95 (41) 9 (43) Aboriginal or Torres Strait Islander, n (%) English as second language, n (%) 4 (2) 3 (1) 1 (5) Education beyond high school, n (%) 41 (16) 37 (16) 4 (19) Employment status, n (%) 130 (51) 124 (53) 6 (29) working (full or part time) 27 (11) 24 (10) 3 (14) not working 19 (7) 17 (7) 2 (10) retired 208 (82) 192 (82) 16 (76) Living alone, n (%) 101 (40) 90 (39) 10 (48) Comorbidities, n (%) d cancer 45 (18) 42 (18) 3 (14) cardiac 151 (59) 138 (59) 13 (62) circulatory 84 (33) 78 (34) 6 (29) mental 44 (17) 40 (17) 4 (19) metabolic 48 (19) 43 (19) 5 (24) musculoskeletal 150 (59) 134 (58) 16 (76) nervous 3 (14) respiratory 22 (9) 19 (8) 12 (57) other 100 (39) 88 (38) 7 (33) Number of comorbidities, n (%) 69 (27) 62 (27) 0 0 (0) 1 to 2 7 (3) 7 (3) 6 (29) 3 100 (39) 94 (40) 15 (71) Had an email address, n (%) 147 (58) 132 (57) 1 (5) Pulmonary function, mean (SD) 165 (65) 164 (70) (n = 20) FEV1 (l) (n = 236) (n = 216) 1.20 (0.27) FEV1 (% predicted) 1.40 (0.66) 1.50 (0.68) 59 (19) FVC (l) 59 (23) 59 (23) 2.00 (0.56) FVC (% predicted) 2.70 (4.87) 2.80 (5.08) 80 (19) FEV1/FVC (%) 79 (25) 79 (25) 60 (13) 59 (18) 59 (18) FEV1 = forced expiratory volume in 1 second, FVC = forced vital capacity. a Participant has personal access to, and uses, a minimum of one technological device in their home. b Participant has no access to, or use of, any technological device. c p < 0.05 represents significant difference between technology engagers and non-engagers. d Multiple responses possible.
]GIF$DT)2_erugi([178 Seidman et al: Technology engagement in pulmonary rehabilitation Percentage of technology 100 email services by 63% (n = 146), browsing news by 56% (n = 131), engagers accessing each device 90 conducting online banking by 37% (n = 86), using social media by 80 30% (n = 71), and online shopping by 22% (n = 52). A higher 70 Laptop computer Tablet Mobile phone education had a significant univariate association with regular 60 computer or tablet use (Table 2). 50 40 Self-rated computer and internet skill competence 30 20 More than half of all participants (57%, n = 144) self-rated their 10 computer and internet skill competence as ‘adequate’, ‘good’ or 0 ‘very good’, with significant associations with higher education Desktop computer and being aged < 70 years (Table 2). In a multivariate regression model, a higher education was the only 7D_T$IF2[]variable (OR 3.86, 95% CI Figure 2. Access to specific devices by technology engagers (n = 233). 2.29 to 6.58) significantly associated with good self-rated computer and internet skill competence. Access to technological devices Accessing health information online Of the technology engagers (n = 233), 21% (n = 48) accessed one device, 41% (n = 95) accessed two devices, 29% (n = 67) accessed Health information was accessed online by 43% (n = 110) of the three devices, and 10% (n = 23) accessed four devices. Access to participants. Being aged < 70 years, having a higher education, different technological devices by technology engagers is pre- high device access, good self-rated computer skill competence, and sented in Figure 2. Ninety-six percent (n = 223) of technology regular computer (desktop or laptop) and tablet use were engagers accessed a mobile phone, of whom 45% (n = 101) had a significantly associated with accessing health information online regular mobile phone, and 55% (n = 122) had a smartphone. (Table 3). In a multivariate regression model, the significant factors Eighteen percent (n = 41) of the technology engagers (n = 233) associated with accessing health information online were being accessed a mobile phone as their sole technology device, whilst aged < 70 years (OR 2.07, 95% CI 1.10 to 3.91), good self-rated 82% (n = 192) accessed a computer (desktop or laptop) or tablet in computer skill competence (OR 5.41, 95% CI 2.55 to 11.48) and addition to their mobile phone. Participants who accessed a regular computer or tablet use (OR 5.21, 95% CI 2.10 to 12.96). This computer or tablet (n = 192) primarily used the devices within model accounted for 39% (Nagelkerke R-square) of the variance in their home (71%, n = 137), whereas 29% (n = 55) of these determining the odds of accessing health information online. participants used them both at home and in the community. The community settings used by the 55 participants were: family Willingness to use telerehabilitation or friends home (55%, n = 30), community library (27%, n = 15), workplace or café (20%, n = 11) and community centre (5%, n = 3). Of all participants, 40% (n = 102) indicated a willingness to use telerehabilitation, while an equal proportion indicated no willing- Higher education and being aged < 70 years were significantly ness to use telerehabilitation, and 20% (n = 51) were undecided associated with high device access ( 3 devices) (Table 2). In the (Figure 3). The variables that were significantly associated with multivariate regression model, a higher education was the only being willing to use telerehabilitation were a higher education, remaining variable that was significantly associated with high high device access, good self-rated computer and internet skill device access (OR 2.32, 95% CI 1.36 to 3.94). competence, and regular computer, tablet and mobile phone use (Table 3). The multivariate regression model found regular Frequency and reasons for use of technology devices computer (desktop or laptop) tablet use (OR 3.14, 95% CI 1.72 to 5.71) and regular mobile use (OR 2.83, 95% CI 1.32 to 6.09) were Of the technology engagers (n = 233), 85% (n = 198) regularly significantly associated with willingness to use telerehabilitation. used (> once per week) mobile phones, while 70% (n = 164) This model accounted for 13% (Nagelkerke R-square) of variance in regularly used computers or tablets. Mobile phones were used for determining the odds of a participant being willing to use phone calls by 98% (n = 218) of the participants who accessed a telerehabilitation. A summary of the motivations of 29% (n = 73) mobile phone. Other reasons for mobile phone use included text of all participants who optionally responded in writing for, or messaging by 64% (n = 142) of participants, using phone features against, their willingness to use telerehabilitation can be found in such as music, photos, games, maps and calendar by 43% (n = 95), Box 1. using apps by 27% (n = 60), internet browsing by 26% (n = 58), emailing by 25% (n = 55), and social media by 17% (n = 38). Reasons for computer internet use by technology engagers included using Table 2 Unadjusted univariate associations between participant characteristics and technology device access, frequency of use and self-rated skill competence. Characteristic High access to technology Technology engagers with Technology engagers with Good self-rated computer Age (< 70 years) devicesa regular frequency of regular frequency of mobile and internet skill (n = 254) computer or tablet useb phone useb competencec (n = 233) (n = 233) (n = 254) % (n) OR (95% CI) % (n) OR (95% CI) % (n) OR (95% CI) % (n) OR (95% CI) 46 2.12 74 1.36 90 2.13 65 1.76 (44/95) (1.25 to 3.60) (69/93) (0.76 to 2.44) (84/93) (0.95 to 4.78) (62/95) (1.04 to 2.98) Gender (male) 36 0.99 67 1.28 87 0.72 59 0.87 (37/104) (0.59 to 1.67) (64/95) (0.72 to 2.25) (83/95) (0.34 to 1.54) (61/104) (0.58 to 1.45) $EDFT_02[]I ducation (higher) 45 2.32 80 2.68 86 1.25 72 3.86 (58/130) (1.36 to 3.94) (99/124) (1.50 to 4.80) (107/124) (0.61 to 2.56) (94/130) (2.29 to 6.54) TD$_IF]C12[ omorbidities ( 3) 35 0.98 72 1.09 82 0.74 52 0.76 (27/77) (0.56 to 1.71) (48/67) (0.58 to 2.04) (55/67) (0.34 to 1.58) (40/77) (0.44 to 1.30) a High access is defined as 3 devices. b Regular frequency is defined as at least once per week. c Good self-rated computer and internet skill competence is defined ‘adequate’, ‘good’ or ‘very good’.
Research 179 Table 3 Unadjusted univariate associations between participant characteristics and accessing health information online and willingness to use telerehabilitation (n = 254). Characteristic Accessing health information online Willingness to use telerehabilitation % (n) OR (95% CI) % (n) OR (95% CI) Age (< 70 years) 56 (53/95) 2.26 (1.34 to 3.79) 66 (63/95) 1.51 (0.89 to 2.56) 39 (40/104) 1.40 (0.84 to 2.33) 64 (67/104) 0.74 (0.44 to 1.24) Gender (male) 56 (73/130) 3.01 (1.79 to 5.05) 69 (89/130) 2.04 (1.22 to 3.39) 36 (28/77) 0.66 (0.38 to 1.15) 52 (40/77) 0.61 (0.36 to 1.05) Education (higher) 62 (56/90) 3.36 (1.96 to 5.74) 72 (65/90) 2.25 (1.29 to 3.91) 66 (95/144) 12.28 (6.45 to 23.39) 73 (105/144) 3.48 (2.05 to 5.89) Comorbidities ( 3) 62 (101/164) 12.22 (5.49 to 27.24) 72 (118/164) 3.34 (1.86 to 5.99) High access to technology devices a[D19_]F$IT 50 (98/198) 2.14 (0.99 to 4.60) 68 (134/198) 3.14 (1.50 to 6.58) Good self-rated computer and internet skill competenceb Regular use of computer (desktop or laptop) or tabletc,d Regular use of mobile phonec,d a High access is defined as 3 devices. b Good self-rated computer and internet skill competence is defined ‘adequate’, ‘good’ or ‘very good’. c Regular frequency is defined as at least once per week. [(Figure_)TD$IG]3 d n = 233. Percentage of participants 100 Uptake of telerehabilitation requires the pulmonary rehabilita- 90 tion population to have access to technological devices. This study 80 Probably would Undecided if would Probably would Definitely would found that a large majority of the study sample have access to some 70 use form of technological device in their home. Mobile phones were 60 not use use or not use the most accessed device, followed closely by computers or tablets. 50 In comparison to reports from other chronic disease populations, 40 such as lung cancer,20F6[2]$DTI_ the present sample had higher proportions 30 of people who accessed technological devices despite being on 20 average 10 years older. Similar to the lung cancer population, the 10 current study found that younger people had an increased 0 likelihood of accessing technological devices. This study also Definitely would found that a higher education was associated with having higher not use access to technological devices. This association is consistent with other Australian data collected from healthy people of comparable Figure 3. Categorisation of participants by willingness to use telerehabilitation age.24 (n = 254). The high rate of regular device access in this study of pulmonary Discussion rehabilitation participants suggests that they have the capacity to engage with telerehabilitation, which favours the likelihood of This is the first study to explore technology engagement and telerehabilitation uptake. The higher rates of regular mobile phone willingness to use telerehabilitation in pulmonary rehabilitation use compared with computer use is consistent with the Australian participants in Australia. The results of the study demonstrated cardiopulmonary hospital outpatient population.21 The current that pulmonary rehabilitation participants have a substantial level study found that the only association with regular computer or of technology engagement and skill, with high access to devices, tablet use was having a higher education, and that there were no which are used regularly, especially mobile phones. Factors that demographic or clinical associations with regular mobile phone were associated with being likely to access health information use. This is likely to be explained by the fact that mobile phones are online were: good self-rated computer and internet skill compe- used regularly by a large majority of people who access the device. tence; regular computer or tablet use; and being aged < 70 years. This study found that the main use of mobile phones was for phone Regular computer, tablet and mobile phone use were factors calls and text messaging, with a quarter accessing the Internet on associated with willingness to use telerehabilitation. Such findings their device. This is in contrast with a younger aged cardiopulmo- are useful in planning future service delivery to people with nary population where 54% use their mobile phones to access the chronic respiratory disease. Box 1. Thematic analysis of willingness to use telerehabilitation. Willingness Theme Example statements Would not use Technically not possible I don’ t understand how to operate computers (Female, 85 yrs) telerehabilitation Preference for group F_[D$]T8I No internet at home (Female, 55 yrs) exercise class FI]T9[D$_ Too complicated for me (Male, 72 yrs) Would use telerehabilitation Prefer physical interaction 0_T]DF$[1I I would need the motivation to attend a class; if left to own with therapist devices I would probably procrastinate (Female, 75 yrs) Convenience Enhance therapy D$T_1[F]I I enjoy being part of the group and like to mix with people (Female, 85 yrs) Desire to use technology ID$F]T[10_ I prefer ‘ in-person’ contact with physio (Female, 77 yrs) FT]_I21[D$ Can’t replace experts (Male, 80 yrs) IF]1D$T_[3 Convenient – time, location, flexibility (Male, 64 yrs) [F]D$T_41I Avoid transport inconvenience (Male, 84 yrs) _IFT[D$]51 Seems a useful way of having regular supervised exercise (Male, 84 yrs) 1][_TD$6FI Direction/guidance for continued exercise after rehab (Female, 64 yrs) F][1DI$T_7 Good if can’t come to class (Female, 64 yrs) FDI[10_T$] I can definitely use Skype to participate (Male, 72 yr) _8]DF$I[1T I enjoy using technology (Female, 67 yrs)
180 Seidman et al: Technology engagement in pulmonary rehabilitation Internet.21 This contrast in findings is explained by Australian data contact. Participants who would use telerehabilitation viewed that found mobile phone internet access was highest amongst the system as a tool of convenience to overcome the barriers of people aged 18 to 34 years at 94% and reduced to 28% among accessing the service and as a method to facilitate long-term people aged over 65 years.25 management. Given that a mobile phone was the device most regularly Clinicians considering implementing pulmonary telerehabil- accessed and used by people attending pulmonary rehabilitation, itation can now do so knowing that it will be an acceptable option it may be beneficial to consider how to best use this technology for a substantial proportion of people with chronic lung disease in the delivery of telerehabilitation. Whilst a mobile phone who are willing to attend pulmonary rehabilitation. Clinicians who may not be appropriate for videoconferencing given the small invest in establishing the format and infrastructure for pulmonary screen size, it is feasible to be used for promoting compliance telerehabilitation can expect an ongoing and growing proportion with exercise training. Mobile phones could be used to increase of pulmonary rehabilitation candidates who will be willing (either exercise motivation through reminders, applications, and SMS immediately or after some training) to use the telerehabilitation technology. The efficacy of a mobile phone-based exercise format. program for COPD, which used a music program to set the tempo of walking speed, was assessed and found to promote A limitation of this study was that the sampled participants good compliance, to be time- and cost-effective, and to have were from a metropolitan population and, therefore, care must be positive clinical outcomes with reduced symptoms and improved taken when considering the use of technology and likelihood of exercise capacity.10T_$DIF82][ telerehabilitation uptake in other geographic settings. This study did not sample people living in rural communities who may The majority of participants self-rated their computer and benefit from telerehabilitation, as it would allow them to receive internet skill competence as adequate or higher. Interestingly, a specialty management whilst still living at home and not need to recent telerehabilitation study found that 43% of people who had travel for care. Aboriginal and Torres Strait Islander people were never used or were not currently using a computer could operate a also poorly represented in the study despite a high prevalence of telerehabilitation computer system following comprehensive chronic respiratory conditions in this population. Future research individual training and the provision of a written education should explore the level of technology engagement and willing- manual.5,17 This result is promising because it suggests that ness to use telerehabilitation for people living rurally and for the computer skill competence is not a barrier to using telerehabilita- Aboriginal and Torres Strait Islander population. All participants tion. The present study found that a higher education was most that were recruited were actively seeking health and disease associated with the participants self-rating their computer and management support and education, which created a potential internet skill competence as adequate or higher. To ensure sampling bias of motivated patients. It would be interesting for clinically acceptable telerehabilitation services, providers need future research to obtain the views of people who are not to consider tailoring the implementation of comprehensive involved in a pulmonary rehabilitation program due to service training for less-educated participants, as well as develop a and/or health barriers, and who may benefit from telerehabilita- telerehabilitation system that can accommodate people of all tion instead. levels of computer skill competence.21 In conclusion, people with chronic respiratory disease of Fewer than half of the people surveyed in the present study moderate severity attending metropolitan-based pulmonary accessed or researched health information online. Despite rehabilitation programs had substantial technology engagement information being freely available in Australia, (eg, Lung Founda- with high device access and use, and adequate or better self- tion Australia), it appears that this education material was not rated computer skill competence. A minority of people were being accessed by the majority of participants. This limited online currently using technology to access health information online. access may have been due to participants accessing face-to-face Forty percent of participants indicated a willingness to use education provided by multidisciplinary health professionals pulmonary telerehabilitation, whereas 20% were undecided, during their pulmonary rehabilitation program. However, access suggesting a positive likelihood of future uptake. The partici- to validated and credible websites may assist patients to effectively pants that were most willing to use pulmonary telerehabilitation self-manage in the community once the pulmonary rehabilitation were those who regularly used a technological device. Such program is completed. This study found that younger patients findings are useful in planning of ways to deliver pulmonary (< 70 years) who regularly used a computer or tablet, and self- rehabilitation services. rated their competence as adequate or higher, were more likely to research health information online. To increase the use of What is already known on this topic: Although people credible health information online, service providers should with chronic lung disease benefit from pulmonary rehabilita- identify older people who do not regularly use a computer and tion, it is delivered to a low proportion of that population. have low self-rated skill competence, who are likely to need Telerehabilitation programs for people with cardiopulmonary individual assistance. disease provide similar improvements in exercise capacity as centre-based programs, with greater compliance. Telerehabilitation is an evolving system of service delivery What this study adds: People attending metropolitan and this study highlighted that 40% of participants were willing pulmonary rehabilitation had substantial technology engage- to use it, whilst 20% remained undecided. This is consistent with ment, high access to devices and good self-rated [3]FDI06_$Ttechno- a study exploring the diabetic population,19 where 62% of people logy skills. Physiotherapists who invest in establishing the were willing to use teletechnology (including videoconferenc- infrastructure for pulmonary telerehabilitation can expect an ing) to manage their disease, and a higher education was the ongoing and growing proportion of candidates who will be primary significant variable associated with being willing to use willing (either immediately or after some training) to use that such technology for health management. In contrast, the format. variables most associated with being willing to use telerehabil- itation in the present study were regular use of computers, Footnotes: a9DF]_$2T[I SPSS 24.0, IBM SPSS Inc, Chicago, USA. tablets and mobile phones. These variables accounted for a small eAddenda: Appendix 1 can be found online at: http://dx.doi.org/ percentage (13%) of the model, with the majority of the 10.1016/j.jphys.2017.05.010. considerations unknown. The contrasting motivations for and Ethics approval: Ethical approval was provided by: South against the use of telerehabilitation, as revealed in the thematic Eastern Sydney Local Health District: HREC 15/273 (LNR/15POWH/ analysis, may explain these unknown considerations. Partici- 512); Northern Sydney Local Health District (LNRSSA/16/HAWKE/ pants who would not use telerehabilitation considered using 4); Concord Repatriation General Hospital (LNRSSA/15/CRGH/274); technology to be daunting and preferred the social and physical motivation from a group setting and face-to-face therapist
Research 181 Royal Prince Alfred Hospital (LNRSSA/15/RPAH/596); St Vincent’s 11. Paneroni M, Colombo F, Papalia A, Colitta A, Borghi G, Saleri M, et al. Is telereh- Hospital (LNRSSA/15/SVH/457). The participant’s completion and abilitation a safe and viable option for patients with COPD? A feasibility study. return of survey provided consent for inclusion within the study. COPD. 2015;12:217–225. Competing interests: Nil. 12. Chaplin E, Hewitt S, Apps L, Edwards K, Brough C, Glab A, et al. The evaluation of an Source(s) of support: This work was supported by the University interactive web-based pulmonary rehabilitation programme: protocol or the WEB of Sydney Honours Student Grant. SPACE for COPD feasibility study. BMJ Open. 2015;5:e008055. Acknowledgements: Thank you to Dr Jennifer Peat who provided statistical analysis advice. 13. Tabak M, Vollenbroek-Hutten MM, van der Valk PD, van der Palen J, Hermens HJ. A Provenance: Not invited. Peer reviewed. telerehabilitation intervention for patients with chronic obstructive pulmonary Correspondence: Zachariah Seidman, Discipline of Physiother- disease: a randomized controlled pilot trial. Clin Rehabil. 2014;28:582–591. apy, Faculty of Health Sciences, University of Sydney, Australia. Email: [email protected] 14. Dinesen B, Huniche L, Toft E. Attitudes of COPD patients towards tele-rehabilita- tion: a cross-sector case study. Int J Environ Res Publ Health. 2013;10:6184–6198. References 15. Chan C, Yamabayashi C, Syed N, Kirkham A, Camp PG. Exercise telemonitoring and 1. McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary telerehabilitation compared with traditional cardiac and pulmonary rehabilita- rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst tion: a systematic review and meta-analysis. Physiother Can. 2016;68:242–251. Rev. 2015;2:CD003793. 16. Hwang R, Bruning J, Morris N, Mandrusiak A, Trevor R. A systematic review of 2. Lung Foundation Australia (LFA). Case Statement: Chronic Obstructive Pulmonary the effects of telerehabilitation in patients with cardiopulmonary diseases. J Disease (COPD). 2001. Available from: http://lungfoundation.com.au/wp-content/ Cardiopulm Rehabil. 2015;35:380–389. uploads/2014/03/COPD-CaseStatement.pdf. (Accessed 4 May 2017) 17. Tsai LLY, McNamara RJ, Dennis SM, Moddel C, Alison JA, McKenzie DK, et al. 3. Keating A, Lee A, Holland AE. What prevents people with chronic obstructive Satisfaction and experience with a supervised home-based real-time videoconfer- pulmonary disease from attending pulmonary rehabilitation? A systematic review. encing telerehabilitation exercise program in people with chronic obstructive Chron Resp Dis. 2011;8:89–99. pulmonary disease (COPD). Int J Telerehab. 2016;8:27–38. 4. Russell TG. Physical rehabilitation using telemedicine. J Telemed Telecare. 2007; 18. Broendum E, Ulrik CS, Gregersen T, Hansen EF, Green A, Ringbaek T. Barriers for 13:217–220. recruitment of patients with chronic obstructive pulmonary disease to a controlled telemedicine trial. Health Inform J. 2016;1–9. 5. Tsai LLY, McNamara RJ, Moddel C, Alison JA, McKenzie DK, McKeough ZJ. Home- based telerehabilitation via real-time videoconferencing improves endurance 19. Saddik B, Al-Dulaijan N. Diabetic patients’ willingness to use tele-technology to exercise capacity in patients with COPD: the randomized controlled TeleR Study. manage their disease – a descriptive study. Online J Public Health Inform. 2015;7: Respirology. 2016;22:699–707. e214. 6. Marquis N, Larivée P, Saey D, Dubois M-F, Tousignant M. In-home pulmonary 20. Granger C, Denehy L, Edbrooke L. The future of telerehabilitation in lung cancer: an telerehabilitation for patients with chronic obstructive pulmonary disease: a pre- observational study investigating access to technology in the lung cancer popula- experimental study on effectiveness, satisfaction, and adherence. Telemed e-Health. tion. Cancer Stud Open Access. 2014;1:111. 2015;21:870–879. 21. Disler RT, Inglis SC, Newton PJ, Currow DC, Macdonald PS, Glanville AR, et al. 7. Holland AE, Hill CJ, Rochford P, Fiore J, Berlowitz DJ, McDonald CF. Telerehabilitation Patterns of technology use in patients attending a cardiopulmonary outpatient for people with chronic obstructive pulmonary disease: feasibility of a simple, real clinic: a self-report survey. Interact J Med Res. 2015;4:e5. time model of supervised exercise training. J Telemed Telecare. 2013;19:222–226. 22. Flesch R. A new readability yardstick. J Appl Psychol. 1948;32:221–233. 8. Tousignant M, Marquis N, Pagé C, Imukuze N, Métivier A, St-Onge A, et al. In-home 23. Lung Foundation Australia. COPD the statistics. 2015. http://lungfoundation. telerehabilitation for older persons with chronic obstructive pulmonary disease: a pilot study. Int J Telerehab. 2012;4:7–13. com.au/healthprofessionals/clinical-resources/copd/copd-the-statistics/. (Accessed 11 November 2015) 9. Stickland MK, Jourdain T, Wong EYL, Rodgers WM, Jendzjowsky NG, MacDonald GF. 24. Australian Communications and Media Authority. Digital lives of older Australians. Using telehealth technology to deliver pulmonary rehabilitation to patients with 2016. http://acma.gov.au/theACMA/engage-blogs/engage-blogs/Research- chronic obstructive pulmonary disease. Can Respir J. 2011;18:216–220. snapshots/Digital-lives-of-older-Australians (Accessed 5 October 2016) 25. Australian Communications and Media Authority. Tablets take off: take-up and use 10. Liu W-T, Wang C-H, Lin H-C, Lin S-M, Lee K-Y, Lo Y-L, et al. Efficacy of a cell phone- of tablet computers in Australia. 2014. http://acma.gov.au/theACMA/engage-blogs/ based exercise programme for COPD. Eur Respir J. 2008;32:651–659. engage-blogs/Research-snapshots/Tablets-take-off-take-up-and-use-of-tablet- computers-in-Australia (Accessed 5 October 2016) Websites http://www.surveysystem.com/sscalc.htm.
Journal of Physiotherapy 63 (2017) 132–143 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Physiotherapists’ beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies Tania Gardner a_2[D$I,6]FT Kathryn Refshauge b, Lorraine Smith a, James McAuley c, Markus Hübscher cDITF$][,_51 Stephen Goodall d a Faculty of Pharmacy, University of Sydney; b Faculty of Health Sciences, University of Sydney; c Neuroscience Research Australia; d Centre for Health Economics Research & Evaluation, University of Technology Sydney, Sydney, Australia KEY WORDS ABSTRACT Beliefs and attitudes Question: What influence do physiotherapists’ beliefs and attitudes about chronic low back pain have on Physical therapy their clinical management of people with chronic low back pain? Design: Systematic review with data Low back pain from quantitative and qualitative studies. Quantitative and qualitative studies were included if they Clinical practice investigated an association between physiotherapists’ attitudes and beliefs about chronic low back pain Patient-centred care and their clinical management of people with chronic low back pain. Results: Five quantitative and five qualitative studies were included. Quantitative studies used measures of treatment orientation and fear avoidance to indicate physiotherapists’ beliefs and attitudes about chronic low back pain. Quantitative studies showed that a higher biomedical orientation score (indicating a belief that pain and disability result from a specific structural impairment, and treatment is selected to address that impairment) was associated with: advice to delay return to work, advice to delay return to activity, and a belief that return to work or activity is a threat to the patient. Physiotherapists’ fear avoidance scores were positively correlated with: increased certification of sick leave, advice to avoid return to work, and advice to avoid return to normal activity. Qualitative studies revealed two main themes attributed to beliefs and attitudes of physiotherapists who have a relationship to their management of chronic low back pain: treatment orientation and patient factors. Conclusion: Both quantitative and qualitative studies showed a relationship between treatment orientation and clinical practice. The inclusion of qualitative studies captured the influence of patient factors in clinical practice in chronic low back pain. There is a need to recognise that both beliefs and attitudes regarding treatment orientation of physiotherapists, and therapist-patient factors need to be considered when introducing new clinical practice models, so that the adoption of new clinical practice is maximised. [Gardner T, Refshauge K, Smith L, McAuley J, Hübscher M, Goodall S (2017) Physiotherapists’ beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies. Journal of Physiotherapy 63: 132–143] © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction approach, where pain is attributed to a structural or biomechanical deficit and treatment aims to address these factors. However, Chronic low back pain is a complex disorder, with multiple training physiotherapists in a biopsychosocial approach to chronic physical, psychological and social factors contributing to poorer low back pain remains limited.11,12 Physiotherapists, for the most recovery and prolonged disability.1–3]$FD15_[IT Clinical practice guidelines part, tend to approach the management of chronic low back pain recommend evaluation of biopsychosocial factors when deciding on the premise of a biomedical model of disease, with treatment on a patient’s management1–3 because they are important focus on a physical pathology and on addressing the symptoms and determinants of outcome2,4,5 and because a biopsychosocial physical impairments.11,12 approach is superior to a biomedically focused approach in chronic low back pain.6 Despite this endorsement by guidelines,1–3 The attitudes and beliefs about health and illness held by physiotherapists tend to adhere poorly to this guidance.7–10 healthcare professionals are likely to play a key role in the approach they take in treating their patients. According to the Physiotherapists have traditionally been at the forefront of the theory of planned behaviour, behaviour is determined by the management of chronic low back pain. Training physiotherapists in attitudes and beliefs that a person has about the likely the management of chronic low back pain focuses on a biomedical consequences of the behaviour.13 Beliefs have been described as http://dx.doi.org/10.1016/j.jphys.2017.05.017 1836-9553/© 2017 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Research 133 ‘a cognitive process resulting in a concrete cognition of how we Box 1. Inclusion criteria. think things are’.14 Attitudes are ‘a more complex cognitive state involving beliefs and feelings as well as values and predispositions Design to act in a certain way’.14 Defining attitudes and beliefs is difficult, Cross-sectional studies due to the complexity and fluidity of the cognitive processes that Qualitative studies underpin them and the influence of environmental and social Participants interaction. This is relevant in chronic low back pain where the Physiotherapists with experience in treating people with individual presentation of a patient and clinical setting can influence the personal attitudes and beliefs of the healthcare chronic low back pain professional.15–17 The patient’s expectations, perceived passivity of Outcome measures the patient, and a desire to maintain a therapeutic relationship Attitudes and beliefs about chronic low back pain have been shown to be factors in the choice of practice.15TIFD_]61[$ Clinical Clinical management of chronic low back pain practice is also influenced by the perceived lack of time a clinician has to fully explore the complexities of chronic low back pain.15 Method Clinical practice in chronic low back pain is influenced by the patient’s pain perception, the patient’s psychosocial status, and the Identification and selection of trials degree of consistency between objective measures and behaviour of the patient.16 Data sources and search strategy This systematic review was conducted and reported in The uncertainty of a definition of attitudes and beliefs is reflected in the difficulty of their measurement. In research, accordance with the PRISMA statement.23 Electronic searches of measures of treatment orientation, fear avoidance, and intolerance Medline, EMBASE, CINAHL, PsychINFO, PubMed and Cochrane of uncertainty are utilised to indirectly imply the attitudes and Library were conducted from January 1995 to February 2016. Hand beliefs of healthcare professionals. The most commonly used searches for relevant articles were also conducted on bibliogra- measure of attitudes and beliefs in physiotherapy research is the phies of identified articles and systematic reviews. The search Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT).18 strategy was developed in consultation with a medical librarian, and The PABS-PT is a validated measure that provides a score of used a combination of keywords and MeSH terms (detailed search treatment orientation of the healthcare professional.19 Treatment strategies are presented in Appendix 1 on the eAddenda). The orientation has been shown to have high correlation with clinical search strategies had three main components: terms for attitudes practice, but it is important to ask whether it truly captures the and/or beliefs; terms for healthcare professional, physical therapist complexity of attitudes and beliefs regarding chronic low back and/or physiotherapist; and terms for chronic low back pain. pain. Study selection and eligibility criteria Healthcare professionals’ attitudes and beliefs have been Quantitative and qualitative studies were included if they shown to influence adherence to guidelines for low back pain, such that a healthcare professional with a biomedical treatment investigated an association between physiotherapists’ attitudes/ orientation and high fear avoidance beliefs is more likely to show beliefs about chronic low back pain and their clinical management poor adherence.20 Other factors associated with poor adherence of people with chronic low back pain. The inclusion criteria are to chronic low back pain guidelines include: lack of knowledge; presented in Box 1. No limit was placed on the measurements used lack of concordance between the biomedical approach and for physiotherapists’ attitudes and beliefs or clinical practice. guidelines; and a belief of the healthcare professional that they Studies were excluded if: they were published in a non-English are poorly trained and under-prepared to adopt a biopsychosocial language; they were published before January 1995, in order to approach.8,21 The attitudes and beliefs of a healthcare profes- capture the timeframe in which current clinical practice guidelines sional affect patients’ attitudes and beliefs, and health out- were developed; the study primarily focused on acute or subacute comes.20 low back pain; or they primarily investigated the association between physiotherapists’ attitudes and beliefs and patients’ Existing studies have largely focused on the attitudes and attitudes and beliefs, outcome expectations, patient satisfaction beliefs of general practitioners or a combination of healthcare and treatment outcomes. professionals.20,22 There is less clarity about the influence of physiotherapists’ attitudes and beliefs regarding chronic low back Two reviewers independently reviewed the titles and abstracts pain on their approaches to treatment of chronic low back pain. of the studies retrieved by the search against the eligibility criteria. Considering that each profession has differing training, practice Full papers were retrieved for evaluation if the paper fulfilled the and treatment goals, it is difficult to assume that general results inclusion criteria, if eligibility was unclear based on the abstract can be applied to all groups. content, or if no abstract was available. Physiotherapists remain at the forefront of chronic low back Data extraction and analysis pain treatment and so it is imperative to have a clear understand- ing of their attitudes and beliefs. An understanding of these Quality attitudes and beliefs, and possible barriers, will enable more Studies meeting the eligibility criteria were assessed for effective implementation of existing guidelines and new treatment models, as well as effective education of physiotherapists about methodological quality. The quality of the quantitative studies chronic low back pain.8 was assessed using a checklist compiled from quality scores for observational studies.24F]I$D[7_T1 The individual criteria that comprised the This systematic review aimed to synthesise the existing checklist are presented in Table 1. The quality of qualitative studies literature to determine the effect of physiotherapists’ beliefs and were assessed using the Critical Appraisal Skills Programme attitudes about chronic low back pain on clinical practice decisions checklist, as used in a systematic review by Fullen et al25 and is in the management of people with chronic low back pain. A recommended by the Cochrane Collaboration qualitative methods synthesis of both quantitative and qualitative studies was chosen group.26_T1$DI]8[F The individual criteria that comprise this checklist are to provide both a measure of association and a richer understand- presented in Table 2. No formal system for interpreting either ing of the association with the inclusion of qualitative studies. checklist was available; therefore, for the purpose of this review, a rating system was devised based on one previously used in another Therefore, the research question for this systematic review was: review.25 If > 60% of the criteria on the checklist were met, the What influence do physiotherapists’ beliefs and attitudes about chronic low back pain have on their clinical management of people with chronic low back pain?
134 Gardner et al: Physiotherapists’ attitudes in chronic low back pain Table 1 Methodological quality for quantitative studies (n = 5) using criteria developed from Sanderson et al53 and STROBE guidelines.54 Study Representative Defined Blinded assessors Follow-up Method of Outcome data Statistical Rating sample sample > 85% assessment reported adjustment Derghazarian 10 Attitudes and beliefs Clinical practice strong Houben 29 Y Y N Y Y Y strong Linton 28 Ya N Y N N/R Y Y Y moderate Pincus 30 N Y Y Y N Y Y N strong Simmonds 31 Y N Y Y N Y Y Y strong Y Y Y Y N Y Y Y Y Y N = no, N/R = not reported, Y = yes. Representative sample: participants selected as consecutive or random cases. Defined sample: description of participant source and inclusion and exclusion criteria. Blinded: unaware of prognostic factors at time of outcome assessment. Follow-up > 85%: outcome data being available for > 85% of participants at one follow-up point. Method of assessment: appropriate outcome measures were used. Outcome data reported: reporting of data at follow-up. Statistical adjustment: multivariate analysis conducted with adjustment for potentially confounding factors. a One random sample and several samples of convenience. Table 2 Methodological quality for qualitative studies (n = 5) using Criteria Appraisal Skills Programme (CASP) criteria. Study Clear Qualitative Appropriate Sampling Data Researcher Ethical Appropriate Clear Research Score statement methodology research collection reflexivity consideration data analysis statement value Daykin 11 appropriate design N of findings 7 Jeffrey 14 of aim N N Y Y Y Y 5 Josephson 32 N Y N N N Y N Y Y 6 Josephson 33 Y N Y N N Y Y N Y Y 7 Poitras 8 Y N Y N N Y Y Y Y Y 8 Y N Y N Y Y Y Y Y N = no, Y = yes. Y Y Y Y Y study was rated as ‘strong’ quality; if 40 to 60% were met, it was Results rated as ‘moderate’ quality; and if < 40% were met, it was scored as ‘poor’ quality. For each included study, two authors (TG, LS) Flow of studies through the review independently carried out assessment of methodological quality. Disagreements were resolved by discussion or resolved by a third Following the search and screening, 262 articles were retrieved author. in full text; from these, five quantitative10,28,29,30,31 and five qualitative papers8,11,14,32,33 were included for analysis. Further Study characteristics details of the search, screening and exclusions are presented in The characteristics extracted from the quantitative studies Figure 1. were: study design, study population, sample size, study aim, Characteristics of included studies whether the sample was random, survey response rate, the measures used for attitudes and beliefs (eg, PABS-PT, Attitudes to Quality Back Pain Scale for musculoskeletal practitioners (ABS-mp)), and Four out of the five quantitative studies were rated as high the measures used for clinical practice (eg, patient vignettes, questionnaire). The characteristics extracted from the qualitative quality; one28 was rated as moderate. Details of which criteria were studies were: method of data collection, method of data analysis, met by which studies are presented in Table 1. All five of the study population, sample size and study aim. qualitative studies were rated as high quality. Details of which criteria were met by which studies are presented in Table 2. Outcome data Data were extracted from the published reports. Where studies Quantitative studies reported data for a mixed group of healthcare professionals, Table 3 summarises the descriptive characteristics of the attempts were made to obtain data specific to physiotherapy included quantitative studies and the associations between participants, with requests made to the original authors. attitudes and beliefs and clinical practice. For the quantitative studies, the outcome data extracted were Measures of beliefs and attitudes correlation and/or regression coefficients for association between There was no consistent method of measuring beliefs and attitudes/beliefs of physiotherapists and clinical practice mea- sures. attitudes across the five quantitative studies; all studies used a different combination of measures. Four of the five quantitative For the qualitative studies, the first author (TG) conducted the studies10,29,30,31D$FI[20_T] used measures of treatment orientation to indicate data synthesis, as described by Sandelowski and Barroso.27TDF]_I[$91 The beliefs and attitudes of physiotherapists. To measure treatment analytic process initially consisted of extraction of findings relating orientation, three studies10,29,31 included the PABS-PT18 and to belief and attitudes of physiotherapists, and effect on clinical two10,30 included the ABS-mp.34 One study28 used a measure of practice and coding of findings for each article. The second stage fear avoidance to infer beliefs and attitudes of physiotherapists. was grouping of findings according to their topical similarity (eg, This study28 derived a fear avoidance questionnaire from several therapist factors, patient factors). The third stage was abstraction existing and validated questionnaires: the Tampa Scale for of findings – analysing the grouped findings to form a set of concise Kinesiophobia, the Fear Avoidance Behaviour Questionnaire, and themes that captured the content of all findings. Frequency of the Pain and Impairment Relationship Scale. One study31 used statements regarding identification and support of a subtheme within each article was also extracted.
Search
