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Intervention development and treatment success in UK health technology assessment funded trials of physical rehabilitation: a mixed methods analysis.

ABSTRACT: OBJECTIVES:Physical rehabilitation is a complex process, and trials of rehabilitation interventions are increasing in number but often report null results. This study aimed to establish treatment success rates in physical rehabilitation trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme and examine any relationship between treatment success and the quality of intervention development work undertaken. DESIGN:This is a mixed methods study. SETTING:This study was conducted in the UK. METHODS:The NIHR HTA portfolio was searched for all completed definitive randomised controlled trials of physical rehabilitation interventions from inception to July 2016. Treatment success was categorised according to criteria developed by Djulbegovic and colleagues. Detailed textual data regarding any intervention development work were extracted from trial reports and supporting publications and informed the development of quality ratings. Mixed methods integrative analysis was undertaken to explore the relationship between quantitative and qualitative data using joint displays. RESULTS:Fifteen trials were included in the review. Five reported a definitive finding, four of which were in favour of the 'new' intervention. Eight trials reported a true negative (no difference) outcome. Integrative analysis indicated those with lower quality intervention development work were less likely to report treatment success. CONCLUSIONS:Despite much effort and funding, most physical rehabilitation trials report equivocal findings. Greater focus on high quality intervention development may reduce the likelihood of a null result in the definitive trial, alongside high quality trial methods and conduct.

SUBMITTER: Goodwin VA

PROVIDER: S-EPMC6720467 | biostudies-other | 2019 Aug

REPOSITORIES: biostudies-other

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Intervention development and treatment success in UK health technology assessment funded trials of physical rehabilitation: a mixed methods analysis.

Goodwin Victoria A VA Hill Jacqueline J JJ Fullam James A JA Finning Katie K Pentecost Claire C Richards David A DA

BMJ open 20190828 8

<h4>Objectives</h4>Physical rehabilitation is a complex process, and trials of rehabilitation interventions are increasing in number but often report null results. This study aimed to establish treatment success rates in physical rehabilitation trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme and examine any relationship between treatment success and the quality of intervention development work undertaken.<h4>Design</h4>This is a mixed ...[more]

PMID: 31467046

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Project description:BackgroundPrevious research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios.MethodsData on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1) statistically significant in favour of the new treatment, 2) statistically significant in favour of the control treatment 3) true negative, 4) truly inconclusive, 5) inconclusive in favour of new treatment or 6) inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials.ResultsData from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not) in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%). The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative). The results were classified as truly inconclusive (i.e. failed to answer the question asked) for 24% of comparisons (20/85). HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials.ConclusionsThe pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that existed were plausible given the differences in the types of trials -HTA trials are more pragmatic. The results indicate HTA trials are compatible with equipoise. This classification usefully summarises the results from clinical trials and enables comparisons of different portfolios of trials.

Project description:BACKGROUND:Wearable technology interventions combined with digital behavior change resources provide opportunities to increase physical activity in adolescents. The implementation of such interventions in real-world settings is unknown. The Raising Awareness of Physical Activity (RAW-PA) study was a 12-week cluster randomized controlled trial targeting inactive adolescents attending schools in socioeconomically disadvantaged areas of Melbourne, Australia. The aim was to increase moderate- to vigorous-intensity physical activity using (1) a wrist-worn Fitbit Flex and app, (2) weekly challenges, (3) digital behavior change resources, and (4) email or text message alerts. OBJECTIVE:This paper presents adolescents' and teachers' perceptions of RAW-PA in relation to program acceptability, feasibility and perceived impact, adolescent engagement and adherence, and the potential for future scale-up. METHODS:A mixed methods evaluation of the RAW-PA study assessed acceptability, engagement, feasibility, adherence, and perceived impact. A total of 9 intervention schools and 144 intervention adolescents were recruited. Only adolescents and teachers (n=17) in the intervention group were included in the analysis. Adolescents completed web-based surveys at baseline and surveys and focus groups postintervention. Teachers participated in interviews postintervention. Facebook data tracked engagement with web-based resources. Descriptive statistics were reported by sex. Qualitative data were analyzed thematically. RESULTS:Survey data were collected from 142 adolescents at baseline (mean age 13.7 years, SD 0.4 years; 51% males) and 132 adolescents postintervention. A total of 15 focus groups (n=124) and 9 interviews (n=17) were conducted. RAW-PA had good acceptability among adolescents and teachers. Adolescents perceived the intervention content as easy to understand (100/120, 83.3%) and the Fitbit easy to use (112/120; 93.3%). Half of the adolescents perceived the text messages to be useful (61/120; 50.8%), whereas 47.5% (57/120) liked the weekly challenges and 38.3% (46/120) liked the Facebook videos. Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention. Adolescents perceived the Fitbit Flex to increase their physical activity motivation (85/120, 70.8%) and awareness (93/119, 78.2%). The web-based delivery facilitated implementation of the intervention, although school-level policies restricting phone use were perceived as potential inhibitors to program roll-out. CONCLUSIONS:RAW-PA showed good acceptability among adolescents attending schools in socioeconomically disadvantaged areas and their teachers. Low levels of teacher burden enhanced their perceptions concerning the feasibility of intervention delivery. Although adolescents perceived that RAW-PA had short-term positive effects on their motivation to be physically active, adolescent adherence and engagement were low. Future research exploring the feasibility of different strategies to engage adolescents with wearable technology interventions and ways of maximizing system-level embeddedness of interventions in practice would greatly advance the field.

Project description:Background:The prevalence of disability in Iran has increased due to ageing of the population and the presence of chronic diseases. However, little is known about the availability of rehabilitation services in Iran. Objective:To study the availability of physical rehabilitation services in Iran. Methods:This was a mixed method study. In the first phase, a qualitative design was conducted for designing an instrument with focus groups based on Service Availability and Readiness Assessment (SARA) instrument (developed by World Health Organization). Content analysis was used for data analysis. Then, in the second phase, a cross-sectional study was performed to collect the data with census method in Iran. This study was formed from June to October 2015, and samples consisted of all governmental, public non-governmental and private facilities established for rehabilitation centers affiliated with the Ministry of Health and Medical Education, Ministry of Labor, Cooperative and Social Welfare and the Iranian Red Crescent Society. Data analyses were performed using SPSS software (version 16). Descriptive statistical analysis (percentage and frequency) were calculated for quantitative data. Results:In the first phase, the content analysis of qualitative data identified a Master Facilities List (MFL) of rehabilitation services and service providers in Iran. Results of the second phase showed that the rate of inpatient, outpatient, community-based and long-term care centers per 1,000,000 populations in Iran were 1.68, 89.24, 66.21 and 3.6, respectively. Also, that the rate of rehabilitation professionals including physical medicine and rehabilitation specialists, physiotherapists, occupational therapists, speech therapists, and audiologists were 3.90, 64.65, 22.09, 22.83 and 24.18 per 1,000,000 populations, respectively. Conclusion:There is a need to increase the availability of rehabilitation services and to promote rehabilitation referrals by using an interdisciplinary team approach.

Project description:To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation.Mixed methods process evaluation in a randomised feasibility study.Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge.Sixty-one older adults (aged ?65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers.Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions.Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context.Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goal-setting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions.Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care.ISRCTN22464643; Post- results.

Project description:INTRODUCTION:Technology has been placed at the centre of global health policy and has been cited as having the potential to increase efficiency and remove geographical boundaries for patients to access care. Communication technology may support patients with orthopaedic problems, which is one of the leading causes of disability worldwide. There are several examples of technology being used in clinical research, although uptake in practice remains low. An understanding of patient preferences will support the design of a communication technology supported treatment pathway for patients undergoing orthopaedic rehabilitation. METHODS AND ANALYSIS:This mixed methods project will be conducted in four phases. In phase I, a systematic review of qualitative studies reporting communication technology use for orthopaedic rehabilitation will be conducted to devise a taxonomy of tasks patients' face when using these technologies to access their care. In phase II, qualitative interviews will investigate how the work of being a patient changes during face-to-face and communication technology consultations and how these changes influence preference. In phase III, a discrete choice experiment will investigate the factors that influence preferences for the use of communication technology for orthopaedic rehabilitation consultations. Phase IV will be a practical application of these results. We will design a 'minimally disruptive' communication technology supported pathway for patients undergoing orthopaedic rehabilitation. ETHICS AND DISSEMINATION:The design of a pathway and underpinning patient preference will assist in understanding factors that might influence technology implementation for clinical care. This study requires ethical approval for phases II, III and IV. Approvals have been received for phase II (approval received on 4 December 2016 from the South Central-Oxford C Research Ethics Committee (IRAS ID: 255172, REC Reference 18/SC/0663)) and phase III (approval received on 18 October 2019 from the London-Hampstead Research Ethics Committee (IRAS ID: 248064, REC Reference 19/LO/1586)) and will be sought for phase IV. All participants will provide informed written consent prior to being enrolled onto the study. PROSPERO REGISTRATION NUMBER:CRD42018100896.

Project description:BackgroundSmart technology use in rehabilitation is growing and can be used remotely to assist clients in self-monitoring their performance. With written home exercise programs being the commonly prescribed form of rehabilitation after discharge, mobile health technology coupled with task-oriented programs can enhance self-management of upper extremity training. In the current study, a rehabilitation system, namely mRehab, was designed that included a smartphone app and 3D-printed household items such as mug, bowl, key, and doorknob embedded with a smartphone. The app interface allowed the user to select rehabilitation activities and receive feedback on the number of activity repetitions completed, time to complete each activity, and quality of movement.ObjectiveThis study aimed to assess the usability, perceived usefulness, and acceptance of the mRehab system by individuals with stroke and identify the challenges experienced by them when using the system remotely in a home-based setting.MethodsA mixed-methods approach was used with 11 individuals with chronic stroke. Following training, individuals with stroke used the mRehab system for 6 weeks at home. Each participant completed surveys and engaged in a semistructured interview. Participants' qualitative reports regarding the usability of mRehab were integrated with their survey reports and quantitative performance data.ResultsOf the 11 participants, 10 rated the mRehab system between the 67.5th and 97.5th percentile on the System Usability Scale, indicating their satisfaction with the usability of the system. Participants also provided high ratings of perceived usefulness (mean 5.8, SD 0.9) and perceived ease of use (mean 5.3, SD 1.5) on a 7-point scale based on the Technology Acceptance Model. Common themes reported by participants showed a positive response to mRehab with some suggestions for improvements. Participants reported an interest in activities they perceived to be adequately challenging. Some participants indicated a need for customizing the feedback to be more interpretable. Overall, most participants indicated that they would like to continue using the mRehab system at home.ConclusionsAssessing usability in the lived environment over a prolonged duration of time is essential to identify the match between the system and users' needs and preferences. While mRehab was well accepted, further customization is desired for a better fit with the end users.Trial registrationClinicalTrials.gov NCT04363944; https://clinicaltrials.gov/ct2/show/NCT04363944.

Project description:BackgroundCommunity-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia.MethodsThis mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members.ResultsThe RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale.ConclusionIn low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness.

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Intervention development and treatment success in UK health technology assessment funded trials of physical rehabilitation: a mixed methods analysis.

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Intervention development and treatment success in UK health technology assessment funded trials of physical rehabilitation: a mixed methods analysis.

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