ORCID Profile
0000-0003-4349-7195
Current Organisations
University of Oxford
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University of Exeter
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Publisher: Elsevier BV
Date: 03-2009
DOI: 10.1016/J.PHYSIO.2008.11.001
Abstract: This paper describes the development and implementation of a physiotherapy intervention for a large multicentred randomised controlled trial of the early management of whiplash injuries in a National Health Service setting. Participants were eligible if they were classified as having whiplash-associated disorder grades I to III and self-referred for treatment within 6 weeks of injury. The intervention development was informed through a variety of methods including the current evidence base, published guidelines, clinician opinion, a pilot study and expert opinion. The intervention was targeted at known, potentially modifiable risk factors for poor recovery, and utilised manual therapy, exercises and psychological strategies. The treatment was in idually tailored, with a maximum of six treatments allowed within the trial protocol over an 8-week period. The intervention was delivered to 300 participants. The amount and types of treatments delivered are described.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 23-04-2018
Publisher: Springer Science and Business Media LLC
Date: 24-11-2012
Abstract: Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be in idually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an in idualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Current Controlled Trials ISRCTN89936343
Publisher: Springer Science and Business Media LLC
Date: 12-2019
DOI: 10.1186/S13063-019-3826-1
Abstract: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0–10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. The clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. ISRCTN registry, ISRCTN54191675 . Registered on 14 November 2017.
Publisher: Springer Science and Business Media LLC
Date: 04-09-2015
Publisher: Elsevier BV
Date: 02-2013
Publisher: Springer Science and Business Media LLC
Date: 13-08-2015
DOI: 10.1007/S00198-015-3261-4
Abstract: Despite the high burden of hip fracture in China, there is limited information on its management. This study investigated the management of hip fractures in a Beijing tertiary hospital and compared practice with that in 180 hospitals in the UK. The findings show a significant gap exists between the countries. The purpose of this study was to determine if the management of older people with hip fractures in a Beijing tertiary hospital is comparable with the UK best practice guidelines for hip fracture management and the UK National Hip Fracture Database 2012, obtained from 180 hospitals. A retrospective audit was undertaken in a large tertiary care hospital in Beijing. Data were compared with the National Hip Fracture Database 2012 collected in 180 hospitals in the UK on the proportion of patients managed according to the UK Blue Book standards. Sixty-six percent of patients were admitted to an orthopaedic ward within 24 h of fracture, while 100 % of patients in the UK were admitted to an orthopaedic ward within 24 h of arrival to an accident and emergency department. Only 8 % of patients received surgery within 48 h of admission compared with 83 % in the UK 10 % received no surgery compared with 2.5 % in the UK and 27 % received orthogeriatrician assessment compared with 70 % in the UK. New pressure ulcers developed in 2 % of patients compared with 3.7 % of those in the UK whereas, 0.3 % of patients were assessed for osteoporosis treatment and 3.8 % received falls assessment, and comparable figures for the UK were 94 and 92 %, respectively. Significant gaps exist in hip fracture management in the Beijing hospital compared with the best practice achieved in 180 UK hospitals, highlighting the need to implement and evaluate proactive strategies to increase the uptake of best practice hip fracture care in China.
Publisher: National Institute for Health and Care Research
Date: 11-2020
DOI: 10.3310/HTA24650
Abstract: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15–30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. An in idually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. The trial took place in 14 NHS physiotherapy departments. People identified as being at high risk of a poor outcome after knee arthroplasty. A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function) Knee injury and Osteoarthritis Outcome Score Quality of Life subscale Physical Activity Scale for the Elderly EuroQol-5 Dimensions, five-level version and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4–7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2–6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval –0.89 to 1.88 points p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. Current Controlled Trials ISRCTN13517704. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 24, No. 65. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 07-2021
DOI: 10.3310/HTA25460
Abstract: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to in iduals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken. To determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care. This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study. Eight NHS trusts in primary and secondary care in England. In total, 1331 participants were randomised (intervention group, n = 430 usual-care group, n = 901) via a secure, remote service. Blinding was not possible. All participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist. The primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness. The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38 p = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss –0.0042, 95% confidence interval –0.0041 to –0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree. Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data. We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care. An evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified. Current Controlled Trials ISRCTN22202133. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 46. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 05-2017
DOI: 10.3310/HTA21260
Abstract: There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials. To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI). We included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1 (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016 and (3) hand-searches of reference lists of relevant systematic reviews from database searches. The project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We ided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes. We included 149 papers from the 22,918 papers screened, referring to 125 in idual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally. Most of the trials included participants with Alzheimer’s disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer’s Society Research Network. Cognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants. We envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog. The project was registered with Core Outcome Measures in Effectiveness Trials [ tudies/details/819?result=true (accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346. The National Institute for Health Research Health Technology Assessment programme.
Publisher: Journal of Orthopaedic & Sports Physical Therapy (JOSPT)
Date: 09-2014
Abstract: Systematic review and meta-analysis. To compare early ankle movement versus ankle immobilization after surgery for ankle fracture on clinical and patient-reported outcomes. A significant proportion of patients undergoing surgery for ankle fracture experience postoperative complications and delayed return to function. The risks and benefits of movement of the ankle in the first 6 weeks after surgery are not known, and clinical practice varies widely. We searched bibliographic databases and reference lists to identify eligible trials. Two independent reviewers conducted data extraction and risk-of-bias assessments. Fourteen trials (705 participants) were included in the review, 11 of which were included in the meta-analysis. The quality of the trials was universally poor. The pooled effect of early ankle movement on function at 9 to 12 weeks after surgery compared to immobilization was inconclusive (standardized mean difference, 0.46 95% confidence interval: -0.02, 0.93 P = .06 I(2) = 72%), and no differences were observed between groups at 1 year. The odds of venous thromboembolism were significantly lower with early ankle movement compared to immobilization (Peto odds ratio = 0.12 95% confidence interval: 0.02, 0.71 P = .02 I(2) = 0%). Deep surgical site infection (Peto odds ratio = 7.08 95% confidence interval: 1.39, 35.99 P = .02 I(2) = 0%), superficial surgical site infection, fixation failure, and reoperation to remove metalwork were more common after early ankle movement compared to immobilization. The quality of evidence is poor. The effects of early movement after ankle surgery on short-term functional outcomes are unclear, but there is no observable difference in the longer term. There is a small reduction in risk of postoperative thromboembolism with early ankle movement. Current evidence suggests that deep and superficial surgical site infections, fixation failure, and the need to remove metalwork are more common after early ankle movement. Level of Evidence Therapy, level 1a-.
Publisher: BMJ
Date: 12-2014
Publisher: BMJ
Date: 07-03-2014
DOI: 10.1136/BMJ.G1687
Abstract: Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and ex les of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
Publisher: American Medical Association (AMA)
Date: 21-09-2021
Publisher: BMJ
Date: 10-2018
DOI: 10.1136/BMJOPEN-2018-022205
Abstract: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target s le size is a minimum of 402. The BOOST programme consists of an in idual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three in idual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study. Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. ISRCTN12698674 Pre-results.
Publisher: Elsevier BV
Date: 11-2016
Publisher: JMIR Publications Inc.
Date: 14-10-2022
Abstract: ournal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies’ risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. e aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. wo independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a s le of diet- and nutrition-related RCTs the second will include a s le of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. he literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random s les of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. ur meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field. ERR1-10.2196/43537
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2016
Publisher: Elsevier BV
Date: 07-0012
Publisher: Elsevier BV
Date: 03-2021
Publisher: Elsevier BV
Date: 03-2021
Publisher: SAGE Publications
Date: 28-07-2016
Abstract: Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. This 2-year randomized controlled trial is being conducted in 2–3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. The primary outcome is patients’ Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. The results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care.
Publisher: Massachusetts Medical Society
Date: 05-11-2020
Publisher: American College of Physicians
Date: 20-06-2017
DOI: 10.7326/M17-0046
Publisher: BMJ
Date: 02-12-2019
DOI: 10.1136/BJSPORTS-2019-101512
Abstract: To assess the effects of exercise interventions for preventing falls in older people living in the community. We included randomised controlled trials evaluating the effects of any form of exercise as a single intervention on falls in people aged 60+years living in the community. Exercise reduces the rate of falls by 23% (rate ratio (RaR) 0.77, 95% CI 0.71 to 0.83 12 981 participants, 59 studies high-certainty evidence). Subgroup analyses showed no evidence of a difference in effect on falls on the basis of risk of falling as a trial inclusion criterion, participant age 75 years+ or group versus in idual exercise but revealed a larger effect of exercise in trials where interventions were delivered by a health professional (usually a physiotherapist). Different forms of exercise had different impacts on falls. Compared with control, balance and functional exercises reduce the rate of falls by 24% (RaR 0.76, 95% CI 0.70 to 0.81 7920 participants, 39 studies high-certainty evidence). Multiple types of exercise (commonly balance and functional exercises plus resistance exercises) probably reduce the rate of falls by 34% (RaR 0.66, 95% CI 0.50 to 0.88 1374 participants, 11 studies moderate-certainty evidence). Tai Chi may reduce the rate of falls by 19% (RaR 0.81, 95% CI 0.67 to 0.99 2655 participants, 7 studies low-certainty evidence). We are uncertain of the effects of programmes that primarily involve resistance training, dance or walking. Given the certainty of evidence, effective programmes should now be implemented.
Publisher: National Institute for Health and Care Research
Date: 02-2022
DOI: 10.3310/JKNZ2003
Abstract: Upper limb problems are common after breast cancer treatment. To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis the unit of randomisation was the in idual (allocated ratio 1 : 1). Breast cancer centres, secondary care. Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants’ mean age was 58.1 years (standard deviation 12.1 years range 28–88 years). Most participants had undergone axillary node clearance surgery (327/392 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of –7.81, 95% confidence interval –12.44 to –3.17 p = 0.001) and complier-average causal effect analyses (adjusted mean difference –8.74, 95% confidence interval –13.71 to –3.77 p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04 p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (–£387, 95% CI –£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. Postal follow-up was lower than estimated however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. This trial is registered as ISRCTN35358984. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 26, No. 15. See the NIHR Journals Library website for further project information.
Publisher: Public Library of Science (PLoS)
Date: 05-08-2015
Publisher: Springer Science and Business Media LLC
Date: 16-02-2021
DOI: 10.1186/S12891-021-04028-8
Abstract: Proven treatments for low back pain, at best, only provide modest overall benefits. Matching people to treatments that are likely to be most effective for them may improve clinical outcomes and makes better use of health care resources. We conducted an in idual participant data meta-analysis of randomised controlled trials of three types of therapist delivered interventions for low back pain (active physical, passive physical and psychological treatments). We applied two statistical methods (recursive partitioning and adaptive risk group refinement) to identify potential subgroups who might gain greater benefits from different treatments from our in idual participant data meta-analysis. We pooled data from 19 randomised controlled trials, totalling 9328 participants. There were 5349 (57%) females with similar ratios of females in control and intervention arms. The average age was 49 years (standard deviation, SD, 14). Participants with greater psychological distress and physical disability gained most benefit in improving on the mental component scale (MCS) of SF-12/36 from passive physical treatment than non-active usual care (treatment effects, 4.3 95% confidence interval, CI, 3.39 to 5.15). Recursive partitioning method found that participants with worse disability at baseline gained most benefit in improving the disability (Roland Morris Disability Questionnaire) outcome from psychological treatment than non-active usual care (treatment effects, 1.7 95% CI, 1.1 to 2.31). Adaptive risk group refinement did not find any subgroup that would gain much treatment effect between psychological and non-active usual care. Neither statistical method identified any subgroups who would gain an additional benefit from active physical treatment compared to non-active usual care. Our methodological approaches worked well and may have applicability in other clinical areas. Passive physical treatments were most likely to help people who were younger with higher levels of disability and low levels of psychological distress. Psychological treatments were more likely to help those with severe disability. Despite this, the clinical importance of identifying these subgroups is limited. The sizes of sub-groups more likely to benefit and the additional effect sizes observed are small. Our analyses provide no evidence to support the use of sub-grouping for people with low back pain.
Publisher: Springer Science and Business Media LLC
Date: 22-06-2009
Publisher: Informa UK Limited
Date: 21-11-2016
Publisher: Springer Science and Business Media LLC
Date: 02-04-2015
Publisher: Springer Science and Business Media LLC
Date: 27-09-2020
DOI: 10.1186/S13054-020-03271-0
Abstract: The ‘Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration In Cardiac Arrest’ (PARAMEDIC2) trial showed that adrenaline improves overall survival, but not neurological outcomes. We sought to determine the within-trial and lifetime health and social care costs and benefits associated with adrenaline, including secondary benefits from organ donation. We estimated the costs, benefits (quality-adjusted life years (QALYs)) and incremental cost-effectiveness ratios (ICERs) associated with adrenaline during the 6-month trial follow-up. Model-based analyses explored how results altered when the time horizon was extended beyond 6 months and the scope extended to include recipients of donated organs. The within-trial (6 months) and lifetime horizon economic evaluations focussed on the trial population produced ICERs of £1,693,003 (€1,946,953) and £81,070 (€93,231) per QALY gained in 2017 prices, respectively, reflecting significantly higher mean costs and only marginally higher mean QALYs in the adrenaline group. The probability that adrenaline is cost-effective was less than 1% across a range of cost-effectiveness thresholds. Combined direct economic effects over the lifetimes of survivors and indirect economic effects in organ recipients produced an ICER of £16,086 (€18,499) per QALY gained for adrenaline with the probability that adrenaline is cost-effective increasing to 90% at a £30,000 (€34,500) per QALY cost-effectiveness threshold. Adrenaline was not cost-effective when only directly related costs and consequences are considered. However, incorporating the indirect economic effects associated with transplanted organs substantially alters cost-effectiveness, suggesting decision-makers should consider the complexity of direct and indirect economic impacts of adrenaline. ISRCTN73485024 . Registered on 13 March 2014.
Publisher: BMJ
Date: 02-2017
Publisher: Springer Science and Business Media LLC
Date: 2014
Publisher: Wiley
Date: 06-06-2016
Publisher: Elsevier BV
Date: 07-2013
Publisher: Springer Science and Business Media LLC
Date: 14-05-2019
Publisher: National Institute for Health and Care Research
Date: 03-2015
DOI: 10.3310/HTA19190
Abstract: The effectiveness of exercise for improving hand and wrist function in people with rheumatoid arthritis (RA) is uncertain. The study aims were (1) to estimate the clinical effectiveness and cost-effectiveness of adding an optimised exercise programme for hands and upper limbs to standard care for patients with RA and (2) to qualitatively describe the experience of participants in the trial with a particular emphasis on acceptability of the intervention, exercise behaviours and reasons for adherence/non-adherence. A pragmatic, multicentred, in idually randomised controlled trial with an embedded qualitative study. Outcome assessors were blind to group assignment and independent of treatment delivery. Seventeen NHS trusts in England comprising 21 rheumatology and therapy departments. Adults with RA who had pain and dysfunction of the hands and/or wrists and had been on stable medication for at least 3 months. Patients were excluded if they were under 18 years old, had undergone upper limb surgery/fracture in the last 6 months, were on a waiting list for upper limb surgery or were pregnant. Usual care or usual care plus an in idualised exercise programme. Usual care consisted of joint protection education, general exercise advice and functional splinting if required. The exercise programme consisted of six sessions of strengthening and stretching exercises with a hand therapist, daily home exercises and strategies to maximise adherence. The primary outcome was the Michigan Hand Outcome Questionnaire (MHQ) overall hand function subscale score at 12 months. Secondary outcome measures included the full MHQ, pain, health-related quality of life (Short Form questionnaire-12 items), impairment (grip strength, dexterity and range of motion) and self-efficacy. European Quality of Life-5 Dimensions, medication and health-care use were collected for the health economics evaluation. Follow-up was at 4 and 12 months post randomisation. Analysis was performed on an intention-to-treat basis. We randomised 490 patients (244 to usual care, 246 to exercise programme). Compliance with the treatments was very good (93% of usual care participants and 75% of exercise programme participants completed treatment). Outcomes were obtained for 89% of participants at 12 months (222 for usual care, 216 for exercise programme). There was a statistically significant difference in favour of the exercise programme for the primary outcome at 4 and 12 months [mean difference 4.6 points, 95% confidence interval (CI) 2.2 to 7.0 points and mean difference 4.4 points, 95% CI 1.6 to 7.1 points, respectively]. There were no significant differences in pain scores or adverse events. The estimated difference in mean quality-adjusted life-years (QALYs) accrued over 12 months was 0.01 greater (95% CI –0.03 to 0.05) in the exercise programme group. Imputed analysis produced incremental cost-effectiveness ratio estimates of £17,941 (0.59 probability of cost-effectiveness at willingness-to-pay threshold of £30,000 per QALY). The qualitative study found the exercise programme to be acceptable and highlighted the importance of the therapist in enabling patients to establish a routine and incorporate the exercises into their lives. The results of the Strengthening And stretching for Rheumatoid Arthritis of the Hand trial suggest that the addition of an exercise programme for RA hands/wrists to usual care is clinically effective and cost-effective when compared with usual care alone. No adverse effects were associated with the exercise programme. The economic analysis suggests that the intervention is likely to be cost-effective. Current Controlled Trials ISRCTN 89936343. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 19. See the NIHR Journals Library website for further project information. This report has been developed in association with the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford and the NIHR Biomedical Research Unit Funding Scheme. This project benefited from facilities funded through Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands.
Publisher: Springer Science and Business Media LLC
Date: 10-09-2009
Publisher: BMJ
Date: 03-2018
DOI: 10.1136/BMJOPEN-2017-019078
Abstract: Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subs le of 20 participants to explore their experiences of the trial interventions. The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. Version 2.1 dated 11 January 2017 ISRCTN35358984 Pre-results.
Publisher: Human Kinetics
Date: 06-2022
Abstract: This systematic review aimed to evaluate the effects of therapeutic exercise on physical and psychosocial outcomes in community-dwelling adults aged 80 years or older. Databases were searched from inception to July 8, 2020. Randomized controlled trials (RCTs) were screened by two reviewers who extracted data and assessed study quality. Sixteen RCTs (1,660 participants) were included. Compared to nonexercise controls there was no evidence of an effect of exercise on performance based (standardized mean differences: 0.58, 95% confidence interval: [−0.19, 1.36] I 2 : 89% six RCTs 290 participants very low-quality evidence) or self-reported physical function (standardized mean differences: 1.35, 95% confidence interval: [−0.78, 3.48] I 2 : 96% three RCTs 280 participants very low-quality evidence) at short-medium term follow-up. Four RCTs reporting psychosocial outcomes could not be combined in meta-analysis and reported varying results. Exercise appeared to reduce the risk of mortality during follow-up (risk ratio: 0.47, 95% confidence interval: [0.32, 0.70] I 2 : 0.0% six RCTs 1,222 participants low-quality evidence).
Publisher: JMIR Publications Inc.
Date: 21-03-2018
Publisher: Springer Science and Business Media LLC
Date: 12-05-2022
DOI: 10.1186/S13063-022-06309-6
Abstract: Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active in iduals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality evidence. We describe a statistical analysis plan (SAP) for the ACL SNNAP randomised controlled trial, which aims to investigate the necessity of surgical management in patients with ACL injuries. ACL SNNAP is a pragmatic, multi-centre, superiority, parallel-group randomised controlled trial in participants with a symptomatic non-acute ACL deficient knee. Participants are allocated in a 1:1 ratio to either non-surgical management (rehabilitation) or surgical management (reconstruction) with the aim of assessing the efficacy and cost-effectiveness. The primary outcome of the study is the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 18 months post-randomisation. The KOOS4 score at 18 months will be evaluated using a linear regression model adjusting for recruitment centre and baseline KOOS4 scores, allowing for intra-centre correlation. A secondary analysis of the primary outcome will be carried out using an area under the curve (AUC) approach using treatment estimates obtained from a mixed model using baseline, 6 months, 12 months, and 18 months post-randomisation outcome data. Secondary outcomes will be measured at 18 months and will include return to activity/level of sport participation, intervention-related complications, the EQ-5D-5L questionnaire, all 5 in idual subscales of the KOOS questionnaire, the ACL-QOL score, expectations of return to activity and cost-effectiveness of the interventions. Missing primary outcome data will be investigated through a sensitivity analysis. Full details of the planned methods for the statistical analysis of clinical outcomes are presented in this paper. The study protocol for the ACL SNNAP trial has been published previously. The methods of analysis for the ACL SNNAP trial have been described here to minimise the risk of data-driven results and reporting bias. Any deviations from the analysis methods described in this paper will be described in full and justified in the publications of the trial results. ISRCTN ISRCTN10110685 . Registered on 16 November 2016
Publisher: Springer Science and Business Media LLC
Date: 13-10-2016
Publisher: National Institute for Health and Care Research
Date: 12-2012
DOI: 10.3310/HTA16490
Abstract: To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were in idually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. Twelve NHS trusts in England comprising 15 EDs. People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were randomised to WBA/active management. Outcome data were obtained at 12 months for 70% and 80% of participants at Step 1 and Step 2, respectively. The majority of people recovered from the injury. Eighteen per cent of the Step 1 cohort had late whiplash syndrome. There was no statistically or clinically significant difference observed in any of the outcomes for participants attending EDs randomised to UCA or active management advice [difference in NDI 0.5, 95% confidence interval (CI) -1.8 to 2.8]. In Step 2 the physiotherapy package resulted in improvements in neck disability at 4 months compared with a single advice session, but these effects were small at the population level (difference in NDI -3.2, 95% CI -5.8 to -0.7). The physiotherapy package was accompanied by a significant reduction in the number of work days lost at 4-month follow-up (difference -40.2, 95% CI -44.3 to -35.8). MINT suggests that enhanced psycho-educational interventions in EDs are no more effective than UCA in reducing the burden of acute whiplash injuries. A physiotherapy package provided to people who have persisting symptoms within the first 6 weeks of injury produced additional short-term benefits in neck disability compared with a single physiotherapy advice session. However, from a health-care perspective, the physiotherapy package was not cost-effective at current levels of willingness to pay. Both experimental treatments were associated with increased cost with no discernible gain in health-related quality of life. However, an important benefit of the physiotherapy package was a reduction in work days lost consequently, the intervention may prove cost-effective at the societal level. Current Controlled Trials ISRCTN33302125. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 16, No. 49. See the HTA programme website for further project information.
Publisher: Springer Science and Business Media LLC
Date: 14-05-2020
DOI: 10.1186/S13063-020-04298-Y
Abstract: Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. The objective of the ACL SNNAP trial is to determine in patients with non-acute anterior cruciate ligament deficiency (ACLD) whether a strategy of non-surgical management (rehabilitation) (with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction) without prior rehabilitation with all patients followed up at 18 months. The study is a pragmatic, multi-centre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Patients with a symptomatic non-acute ACL deficient knee will be randomised to either non-surgical management (rehabilitation) or surgical management (reconstruction). We aim to recruit 320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom. Randomisation will occur using a web-based randomisation system. Blinding of patients and clinicians to treatment allocation will not be possible because of the nature of the interventions. Participants will be followed up via self-reported questionnaires at 6, 12 and 18 months. The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 18 months post randomisation. Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage. At present, no evidence-based treatment of non-acute ACL deficiency exists, particularly in the NHS. Moreover, little consensus exists on the management approach for these patients. The proposed trial will address this gap in knowledge regarding the clinical and cost effectiveness of ACL treatment and inform future standards of care for this condition. ISRCTN: 10110685 . Registered on 16 November 2016. ClinicalTrials.gov: NCT02980367 . Registered in December 2016.
Publisher: Springer Science and Business Media LLC
Date: 18-04-2021
Publisher: Informa UK Limited
Date: 24-08-2016
DOI: 10.1080/09638288.2016.1212111
Abstract: This study explores the experience of participants taking part in a hand exercise programme for people with rheumatoid arthritis with a focus on adherence. The exercise programme was tested in a randomised controlled trial. This parallel qualitative study will inform future implementation into clinical practice. Twenty-seven semi-structured interviews from 14 participants were undertaken at two time points (4 and 12 months after randomisation). We collected data of participants' experiences over time. This was guided by an interview schedule. Interview data were analysed using interpretative phenomenological analysis which is informed by phenomenological and hermeneutic theory. We recruited participants from National Health Service rheumatology and therapy departments. At 4 months, 11/14 participants reported continuing with the exercises. By 12 months, 7/13 participants still reported exercising. The ability to establish a routine determined whether participants adhered to the exercise programme. This was sometimes influenced by practical issues. We also identified facilitators and barriers to regular exercise in the themes of the following: the therapeutic encounter, perceived benefit of exercises, attitude of mind, confidence, and unpredictability. Establishing a routine was an important step towards participants being able to exercise independently. Therapists provided participants with skills to continue to exercise while dealing with changes in symptoms and schedules. Potential barriers to long-term exercise adherence need to be taken into account and addressed for successful implementation of this programme. Implications for Rehabilitation Behavioural change components such as the use of an exercise planner (stating intentions of where, when and how), daily diary sheets, and joint goal setting enhance adherence to a hand exercise programme for RA by helping to establish routines. Exercise routines need to be flexible enough to fit in with life and symptom changes whilst delivering a sufficient dosage. Therapists facilitate this process by using behavioural components alongside more commonly used aspects of care (assessment, education, advice, and encouragement) to enable people with RA to become independent exercisers.
Publisher: Springer Science and Business Media LLC
Date: 18-06-2016
Publisher: Springer Science and Business Media LLC
Date: 14-01-2020
DOI: 10.1186/S13063-019-4021-0
Abstract: Bayesian adaptive designs can be more efficient than traditional methods for multi-arm randomised controlled trials. The aim of this work was to demonstrate how Bayesian adaptive designs can be constructed for multi-arm phase III clinical trials and assess potential benefits that these designs offer. We constructed several alternative Bayesian adaptive designs for the Collaborative Ankle Support Trial (CAST), which was a randomised controlled trial that compared four treatments for severe ankle sprain. These designs incorporated response adaptive randomisation (RAR), arm dropping, and early stopping for efficacy or futility. We studied the operating characteristics of the Bayesian designs via simulation. We then virtually re-executed the trial by implementing the Bayesian adaptive designs using patient data s led from the CAST study to demonstrate the practical applicability of the designs. We constructed five Bayesian adaptive designs, each of which had high power and recruited fewer patients on average than the original designs target s le size. The virtual executions showed that most of the Bayesian designs would have led to trials that declared superiority of one of the interventions over the control. Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis. Similar estimates and conclusions were obtained from the Bayesian adaptive designs as from the original trial. Using CAST as an ex le, this case study shows how Bayesian adaptive designs can be constructed for phase III multi-arm trials using clinically relevant decision criteria. These designs demonstrated that they can potentially generate earlier results and allocate more patients to better performing arms. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. CAST study registration ISRCTN, ISRCTN37807450 . Retrospectively registered on 25 April 2003.
Publisher: Elsevier BV
Date: 09-2011
DOI: 10.1016/J.PHYSIO.2010.11.003
Abstract: Low back pain is a complex condition, often recurring or chronic, which has proved difficult to characterise. To explore an alternative approach to assessing low back pain, an expert panel adapted the 'Miracle Question' from Solution-Focused Brief Therapy. This asks about a forward scenario of waking without the problems that the client had presented with. The question was adapted to: What would you do if you did not have back pain? To explore the use of the Adapted Miracle Question (AMQ) within an interview study of patients with low back pain. The AMQ was used in an interview study of 34 participants recruited from the UK Back Skills Training (BeST) trial, assessing the effectiveness of a cognitive behavioural approach intervention for the management of low back pain. Responses to the AMQ were analysed thematically and then case by case. Interviewees talked about details of their activities and ability to function that would be different, and about change to their quality of life. Some talked about work. Five interviewees said that it would make no difference to them. When considered overall, the responses could be categorised as: no change some change in activity/function a return to their pre-back pain state and life would be transformed. The AMQ was straightforward to ask and prompted a breadth of responses which may be useful in tailoring treatment. This question warrants further evaluation in the clinical setting.
Publisher: Wiley
Date: 23-07-2018
Publisher: SAGE Publications
Date: 27-07-2010
Abstract: We aim to answer the question: How can we develop an evidence base that will assist tailoring health interventions to in idual patients? Using social theory and interview data from people living with chronic illness, we developed a new approach to analysis. In iduals were considered as emergent complex systems, adjusting and adapting within their environment and sometimes transforming. The notion of illness trajectory brought our attention to data in the interviews about the “emergent present,” the current period of time when all domains of life, from across time, have expression. We summarized patterns of adjustment and adaptation within the emergent present for people living with chronic back pain, depression, and diabetes. We considered the potential of this analysis approach to inform medical decision making. Our analysis approach is the first step in developing a categorization of in iduals that might be useful in tailoring health care interventions to the in idual.
Publisher: National Institute for Health and Care Research
Date: 05-2013
DOI: 10.3310/HTA17180
Publisher: Public Library of Science (PLoS)
Date: 20-01-2017
Publisher: BMJ
Date: 04-2017
Publisher: Elsevier BV
Date: 03-2018
DOI: 10.1016/J.PHYSIO.2017.03.007
Abstract: Our objectives were two-fold: (i) to describe physiotherapists' experiences of implementing a cognitive behavioural approach (CBA) for managing low back pain (LBP) after completing an extensive online training course (iBeST), and (ii) to identify how iBeST could be enhanced to support long-term implementation before scale up for widespread use. We conducted semi-structured interviews with 11 physiotherapists from six National Health Service departments in the Midlands, Oxfordshire and Derbyshire. Questions centred on (i) using iBeST to support implementation, (ii) what barriers they encountered to implementation and (iii) what of information or resources they required to support sustained implementation. Interviews were transcribed and thematically analysed using NVivo. Themes were categorised using the Theoretical Domains Framework (TDF). Evidence-based techniques were identified using the behaviour change technique taxonomy to target relevant TDF domains. Three themes emerged from interviews: anxieties about using a CBA, experiences of implementing a CBA, and sustainability for future implementation of a CBA. Themes crossed multiple TDF domains and indicated concerns with knowledge, beliefs about capabilities and consequences, social and professional roles, social influences, emotion, and environmental context and resources. We identified evidence-based strategies that may support sustainable implementation of a CBA for LBP in a physiotherapy setting. This study highlighted potential challenges for physiotherapists in the provision of evidence-based LBP care within the current UK NHS. Using the TDF provided the foundation to develop a tailored, evidence-based, implementation intervention to support long term use of a CBA by physiotherapists managing LBP within UK NHS outpatient departments.
Publisher: BMJ
Date: 09-2022
DOI: 10.1136/BMJOPEN-2021-060128
Abstract: Neurogenic claudication (NC) causes pain and reduced mobility, particularly in older people, and can negatively affect mental and social well-being, so limiting successful ageing. This qualitative study explored how people with NC changed over 12 months. A longitudinal qualitative study using semi-structured interviews. Participants were recruited from a UK clinical trial of a physiotherapy intervention for NC. Interviews were undertaken at baseline, 1 month after receiving any intervention and at 12 months. We analysed 30 sets of three interviews. Interview data were summarised for each time point into biopsychosocial domains: pain, mobility and activities of daily living, psychological impact, and social and recreational participation. Through comparative analysis we explored participant trajectories over time. Progressive improvement in at least one domain was experienced by 13 participants, but there was variability in trajectories with early improvements that remained the same, transient changes and no change also commonly observed. Eleven participants described co-present improvement trajectories in all domains. Three participants described co-present improvement in all domains except participation one had never stopped their participation and two had unattainable expectations. Five participants described co-present improvement in one domain and deterioration in another and 14 participants described co-present no change in one domain and change in another. There was evidence of interaction between domains for ex le, improved mobility led to improved participation and for some participants, specific factors influenced change. Of the 15 participants who experienced improved participation, 10 reported improvements in all other domains and five participants did not for two, pain did not prevent participation, one used a walking aid and two had a positive psychological outlook. The daily lived experiences of older adults with NC are variable and include interaction between biopsychosocial domains. Therapist understanding of these trajectories and their interactions may help to provide personalised therapy ISRCTN12698674
Publisher: JMIR Publications Inc.
Date: 13-12-2017
DOI: 10.2196/JMIR.8424
Publisher: American Medical Association (AMA)
Date: 06-2022
Publisher: National Institute for Health and Care Research
Date: 11-2021
DOI: 10.3310/HTA25660
Abstract: Although routine NHS data potentially include all patients, confounding limits their use for causal inference. Methods to minimise confounding in observational studies of implantable devices are required to enable the evaluation of patients with severe systemic morbidity who are excluded from many randomised controlled trials. Stage 1 – replicate the Total or Partial Knee Arthroplasty Trial (TOPKAT), a surgical randomised controlled trial comparing unicompartmental knee replacement with total knee replacement using propensity score and instrumental variable methods. Stage 2 – compare the risk benefits and cost-effectiveness of unicompartmental knee replacement with total knee replacement surgery in patients with severe systemic morbidity who would have been ineligible for TOPKAT using the validated methods from stage 1. This was a cohort study. Data were obtained from the National Joint Registry database and linked to hospital inpatient (Hospital Episode Statistics) and patient-reported outcome data. Stage 1 – people undergoing unicompartmental knee replacement surgery or total knee replacement surgery who met the TOPKAT eligibility criteria. Stage 2 – participants with an American Society of Anesthesiologists grade of ≥ 3. The patients were exposed to either unicompartmental knee replacement surgery or total knee replacement surgery. The primary outcome measure was the postoperative Oxford Knee Score. The secondary outcome measures were 90-day postoperative complications (venous thromboembolism, myocardial infarction and prosthetic joint infection) and 5-year revision risk and mortality. The main outcome measures for the health economic analysis were health-related quality of life (EuroQol-5 Dimensions) and NHS hospital costs. In stage 1, propensity score stratification and inverse probability weighting replicated the results of TOPKAT. Propensity score adjustment, propensity score matching and instrumental variables did not. Stage 2 included 2256 unicompartmental knee replacement patients and 57,682 total knee replacement patients who had severe comorbidities, of whom 145 and 23,344 had linked Oxford Knee Scores, respectively. A statistically significant but clinically irrelevant difference favouring unicompartmental knee replacement was observed, with a mean postoperative Oxford Knee Score difference of 2 points using propensity score stratification no significant difference was observed using inverse probability weighting. Unicompartmental knee replacement more than halved the risk of venous thromboembolism [relative risk 0.33 (95% confidence interval 0.15 to 0.74) using propensity score stratification relative risk 0.39 (95% confidence interval 0.16 to 0.96) using inverse probability weighting]. Unicompartmental knee replacement was not associated with myocardial infarction or prosthetic joint infection using either method. In the long term, unicompartmental knee replacement had double the revision risk of total knee replacement [hazard ratio 2.70 (95% confidence interval 2.15 to 3.38) using propensity score stratification hazard ratio 2.60 (95% confidence interval 1.94 to 3.47) using inverse probability weighting], but half of the mortality [hazard ratio 0.52 (95% confidence interval 0.36 to 0.74) using propensity score stratification insignificant effect using inverse probability weighting]. Unicompartmental knee replacement had lower costs and higher quality-adjusted life-year gains than total knee replacement for stage 2 participants. Although some propensity score methods successfully replicated TOPKAT, unresolved confounding may have affected stage 2. Missing Oxford Knee Scores may have led to information bias. Propensity score stratification and inverse probability weighting successfully replicated TOPKAT, implying that some (but not all) propensity score methods can be used to evaluate surgical innovations and implantable medical devices using routine NHS data. Unicompartmental knee replacement was safer and more cost-effective than total knee replacement for patients with severe comorbidity and should be considered the first option for suitable patients. Further research is required to understand the performance of propensity score methods for evaluating surgical innovations and implantable devices. This trial is registered as EUPAS17435. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 66. See the NIHR Journals Library website for further project information.
Publisher: Informa UK Limited
Date: 30-04-2014
DOI: 10.3109/09638288.2014.913705
Abstract: This interview study aimed to capture an account of change in low back pain over time and understand the interaction of known bio-psychosocial risk factors. Thirty-four participants from the Back Skills Training (BeST) U.K. trial, evaluating a cognitive behavioural approach intervention for LBP, gave 61 interviews. Semi-structured interviews taken once or twice post intervention explored participants' experiences of LBP and the intervention received. Initial thematic analysis of the data gave themes, which participants spoke about in an integrated way. Rereading of whole transcripts identified interactions between themes, which we classified as helpful or unhelpful to recovery. The team also explored whether there were correlations with Roland and Morris Disability Questionnaire (RMDQ) scores from the main trial. Web diagrams gave a graphic representation of the interactions between factors, which were highly in idual and time specific. We identified three categories of webs dense web (mostly unhelpful), open web (helpful and unhelpful) and sparse web (mostly helpful). These categories correlated with (RMDQ) scores. Facilitators as well as potential barriers to recovery give added insight when considering psychosocial risk factors. Web categories highlight patterns of interaction between psychosocial factors, which underlie levels of disability. These patterns of interaction may help to guide clinicians in their choice of treatment approaches.
Publisher: Medical Journals Sweden AB
Date: 2002
Publisher: Springer Science and Business Media LLC
Date: 22-02-2007
Publisher: Public Library of Science (PLoS)
Date: 13-03-2015
Publisher: Georg Thieme Verlag KG
Date: 29-01-2016
Abstract: Nur wenn Interventionsbeschreibungen vollständig veröffentlicht sind, können Kliniker und Patienten Interventionen, die sich als nützlich erwiesen haben, verlässlich umsetzen und andere Forscher die Studienergebnisse replizieren oder darauf aufbauen. Die Qualität von Interventionsbeschreibungen in wissenschaftlichen Publikationen ist bemerkenswert gering. Um die Vollständigkeit der Berichterstattung und damit die Replizierbarkeit von Interventionen zu verbessern, entwickelte eine internationale Gruppe von Experten und Interessensvertretern die Checkliste zur Interventionsbeschreibung und Replikation (TIDieR). Der Prozess beinhaltete eine Literaturrecherche zu relevanten Checklisten und wissenschaftlichen Untersuchungen, eine Delphi-Umfrage mit internationalen Experten zur Steuerung der Item-Auswahl und eine Expertenkonferenz. Die daraus resultierende 12-Item-TIDieR Checkliste (Bezeichnung, Warum, Was (Materialien), Was (Verfahren), Wer intervenierte, Wie, Wo, Wann und Wieviel, Anpassungen, Modifikationen, Wie gut (geplante Durchführungskontrolle), Wie gut (tatsächliche Durchführung)) ist eine Erweiterung des CONSORT 2010 Statements (Item 5) und des SPIRIT 2013 Statements (Item 11). Während der Fokus der Checkliste auf klinischen Studien liegt, kann die erweiterte Anleitung bei allen evaluativen Studiendesigns herangezogen werden. Dieser Artikel präsentiert die TIDieR Checkliste und Anleitung mit Erklärung und Erläuterung jedes einzelnen Items sowie Beispielen guter Berichterstattung. Die TIDieR Checkliste und Anleitung sollen das Berichten von Interventionen verbessern und Autoren eine Hilfe bieten, die Berichterstattung ihrer Interventionen zu strukturieren, Gutachtern und Herausgebern, die Beschreibungen zu beurteilen und Lesern, die Informationen zu nutzen.
Publisher: BMJ
Date: 09-1212
DOI: 10.1136/BMJOPEN-2020-037516
Abstract: The ‘Oxford Pain, Activity and Lifestyle’ (OPAL) Cohort is a longitudinal, prospective cohort study of adults, aged 65 years and older, living in the community which is investigating the determinants of health in later life. Our focus was on musculoskeletal pain and mobility, but the cohort is designed with flexibility to include new elements over time. This paper describes the study design, data collection and baseline characteristics of participants. We also compared the OPAL baseline characteristics with nationally representative data sources. We randomly selected eligible participants from two stratified age bands (65–74 and 75 and over years). In total, 5409 in iduals (42.1% of eligible participants) from 35 general practices in England agreed to participate between 2016 and 2018. The majority of participants (n=5367) also consented for research team to access their UK National Health Service (NHS) Digital and primary healthcare records. Mean participant age was 74.9 years (range 65–100) 51.5% (n=2784/5409) were women. 94.9% of participants were white, and 28.8% lived alone. Over 83.0% reported pain in at least one body area in the previous 6 weeks. Musculoskeletal symptoms were more prevalent in women (86.4%). One-third of participants reported having one or more falls in the last year. Most participants were confident in their ability to walk outside. The characteristics of OPAL Cohort participants were broadly similar to the general population of the same age. Postal follow-up of the cohort is being undertaken at annual intervals, with data collection ongoing. Linkage to NHS hospital admission data is planned. This English prospective cohort offers a large and rich resource for research on the longitudinal associations between demographic, clinical, and social factors and health trajectories and outcomes in community-dwelling older people.
Publisher: Elsevier BV
Date: 2015
Publisher: National Institute for Health and Care Research
Date: 08-2010
DOI: 10.3310/HTA14410
Abstract: To estimate the clinical effectiveness of active management (AM) in general practice versus AM plus a group-based, professionally led cognitive behavioural approach (CBA) for subacute and chronic low back pain (LBP) and to measure the cost of each strategy over a period of 12 months and estimate cost-effectiveness. Pragmatic multicentred randomised controlled trial with investigator-blinded assessment of outcomes. Fifty-six general practices from seven English regions. People with subacute and chronic LBP who were experiencing symptoms that were at least moderately troublesome. Participants were randomised (in a ratio of 2:1) to receive either AM+CBA or AM alone. Primary outcomes were the Roland Morris Disability Questionnaire (RMQ) and the Modified Von Korff Scale (MVK), which measure LBP and disability. Secondary outcomes included mental and physical health-related quality of life (Short Form 12-item health survey), health status, fear avoidance beliefs and pain self-efficacy. Cost-utility of CBA was considered from both the UK NHS perspective and a broader health-care perspective, including both NHS costs and costs of privately purchased goods and services related to LBP. Quality-adjusted life-years (QALYs) were calculated from the five-item EuroQoL. Between April 2005 and April 2007, 701 participants were randomised: 233 to AM and 468 to AM+CBA. Of these, 420 were female. The mean age of participants was 54 years and mean baseline RMQ was 8.7. Outcome data were obtained for 85% of participants at 12 months. Benefits were seen across a range of outcome measures in favour of CBA with no evidence of group or therapist effects. CBA resulted in at least twice as much improvement as AM. Mean additional improvement in the CBA arm was 1.1 [95% confidence interval (CI) 0.4 to 1.7], 1.4 (95% CI 0.7 to 2.1) and 1.3 (95% CI 0.6 to 2.1) change points in the RMQ at 3, 6 and 12 months respectively. Additional improvement in MVK pain was 6.8 (95% CI 3.5 to 10.2), 8.0 (95% CI 4.3 to 11.7) and 7.0 (95% CI 3.2 to 10.7) points, and in MVK disability was 4.3 (95% CI 0.4 to 8.2), 8.1 (95% CI 4.1 to 12.0) and 8.4 (95% CI 4.4 to 12.4) points at 3, 6 and 12 months respectively. At 12 months, 60% of the AM+CBA arm and 31% of the AM arm reported some or complete recovery. Mean cost of attending a CBA course was 187 pounds per participant with an additional benefit in QALYs of 0.099 and an additional cost of 178.06 pounds. Incremental cost-effectiveness ratio was 1786.00 pounds. Probability of CBA being cost-effective reached 90% at about 3000 pounds and remained at that level or above at a cost-effectiveness threshold of 20,000 pounds the CBA group had an almost 100% probability of being considered cost-effective. User perspectives on the acceptability of group treatments were sought through semi-structured interviews. Most were familiar with key messages of AM most who had attended any group sessions had retained key messages from the sessions and two-thirds talked about a reduction in fear avoidance and changes in their behaviour. Group sessions appeared to provide reassurance, lessen isolation and enable participants to learn strategies from each other. Long-term effectiveness and cost-effectiveness of CBA in treating subacute and chronic LBP was shown, making this intervention attractive to patients, clinicians and purchasers. Short-term (3-month) clinical effects were similar to those found in high-quality studies of other therapies and benefits were maintained and increased over the long term (12 months). Cost per QALY was about half that of competing interventions for LBP and because the intervention can be delivered by existing NHS staff following brief training, the back skills training programme could be implemented within the NHS with relative ease. Current Controlled Trials ISRCTN37807450. The National Institute for Health Research Health Technology Assessment programme.
Publisher: Springer Science and Business Media LLC
Date: 18-06-2018
Publisher: SAGE Publications
Date: 09-06-2020
Abstract: With the rapid advancement in digital technologies, the use of digital health applications is increasing day by day. Although a large number of digital applications have been developed for rehabilitation of older people, there has been no review of the evidence for effectiveness of these interventions. The aim of our study was to review the evidence of digital rehabilitation interventions on outcomes including pain, function and quality of life in older people. We focused on digital interventions that are designed to improve and restore physical functioning. We searched six electronic bibliographic databases and included randomised controlled trials. Cochrane risk of bias tool and Cochrane’s Grading of Recommendations, Assessment, Development and Evaluation approach was used to evaluate the risk of bias and grade the evidence. Eight trials were included. The short-term effects of digital rehabilitation interventions on physical activity, quality of life, vertigo symptoms and falls are uncertain. Quality of trials was rated as very low to moderate evidence. More research is needed to estimate effectiveness of these interventions.
Publisher: F1000 Research Ltd
Date: 25-06-2021
DOI: 10.12688/F1000RESEARCH.52313.1
Abstract: Background: Falls in older people are a major cause of morbidity and mortality. There is some evidence to suggest that home hazard assessment and environmental modification delivered by an occupational therapist may reduce falls. The objective of this study was to evaluate the effectiveness of this intervention, relative to usual care. Methods: A pragmatic, two-arm modified cohort randomised controlled trial in eight NHS trusts in primary and secondary care in England. In total, 1331 community-dwelling adults aged 65 years and over with a history of falls or fear of falling were randomised in a 2:1 allocation to either usual care plus a falls prevention leaflet (n=901) or to receive the home hazard assessment and environmental modification intervention, plus usual care and a falls prevention leaflet (n=430). The primary outcome was the number of falls per participant over the 12 months from randomisation. Secondary outcomes included: proportion of fallers and multiple fallers, time to fall, and fear of falling. Results: All 1331 randomised participants (mean age 80 years, 872 [65.5%] female) were included in the primary analysis. There was a small increase in the rate of falls in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% CI 0.99 to 1.38 p=0.07). A similar proportion of participants in the intervention (57.0%) and usual care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the other secondary outcomes and no serious, related adverse events were reported. Conclusions: Home hazard assessment and environmental modification delivered by an occupational therapist did not reduce falls in community-dwelling older people deemed at higher risk of falling recruited to this trial.
Publisher: Springer Science and Business Media LLC
Date: 04-2023
DOI: 10.1186/S40814-023-01275-5
Abstract: Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants ( n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible in iduals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO) or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence (2) s le size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme. Progression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design. ISRCTN75983430. Registered 3/12/2021. www.isrctn.com/ISRCTN75983430.
Publisher: Research Square Platform LLC
Date: 27-01-2020
Abstract: Background There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). Methods/Design AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. Discussion The development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.
Publisher: National Institute for Health and Care Research
Date: 02-2021
DOI: 10.3310/HTA25090
Abstract: Cognitive–behavioural therapy aims to increase quality of life by changing cognitive and behavioural factors that maintain problematic symptoms. A previous overview of cognitive–behavioural therapy systematic reviews suggested that cognitive–behavioural therapy was effective for many conditions. However, few of the included reviews synthesised randomised controlled trials. This project was undertaken to map the quality and gaps in the cognitive–behavioural therapy systematic review of randomised controlled trial evidence base. Panoramic meta-analyses were also conducted to identify any across-condition general effects of cognitive–behavioural therapy. The overview was designed with cognitive–behavioural therapy patients, clinicians and researchers. The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Child Development & Adolescent Studies, Database of Abstracts of Reviews of Effects and OpenGrey databases were searched from 1992 to January 2019. Study inclusion criteria were as follows: (1) fulfil the Centre for Reviews and Dissemination criteria (2) intervention reported as cognitive–behavioural therapy or including one cognitive and one behavioural element (3) include a synthesis of cognitive–behavioural therapy trials (4) include either health-related quality of life, depression, anxiety or pain outcome and (5) available in English. Review quality was assessed with A MeaSurement Tool to Assess systematic Reviews (AMSTAR)-2. Reviews were quality assessed and data were extracted in duplicate by two independent researchers, and then mapped according to condition, population, context and quality. The effects from high-quality reviews were pooled within condition groups, using a random-effect panoramic meta-analysis. If the across-condition heterogeneity was I 2 75%, we pooled across conditions. Subgroup analyses were conducted for age, delivery format, comparator type and length of follow-up, and a sensitivity analysis was performed for quality. A total of 494 reviews were mapped, representing 68% (27/40) of the categories of the International Classification of Diseases, Eleventh Revision, Mortality and Morbidity Statistics. Most reviews (71%, 351/494) were of lower quality. Research on older adults, using cognitive–behavioural therapy preventatively, ethnic minorities and people living outside Europe, North America or Australasia was limited. Out of 494 reviews, 71 were included in the primary panoramic meta-analyses. A modest effect was found in favour of cognitive–behavioural therapy for health-related quality of life (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval –0.05 to 0.50, I 2 = 32%), anxiety (standardised mean difference 0.30, 95% confidence interval 0.18 to 0.43, prediction interval –0.28 to 0.88, I 2 = 62%) and pain (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval –0.28 to 0.74, I 2 = 64%) outcomes. All condition, subgroup and sensitivity effect estimates remained consistent with the general effect. A statistically significant interaction effect was evident between the active and non-active comparator groups for the health-related quality-of-life outcome. A general effect for depression outcomes was not produced as a result of considerable heterogeneity across reviews and conditions. Data extraction and analysis were conducted at the review level, rather than returning to the in idual trial data. This meant that the risk of bias of the in idual trials could not be accounted for, but only the quality of the systematic reviews that synthesised them. Owing to the consistency and homogeneity of the highest-quality evidence, it is proposed that cognitive–behavioural therapy can produce a modest general, across-condition benefit in health-related quality-of-life, anxiety and pain outcomes. Future research should focus on how the modest effect sizes seen with cognitive–behavioural therapy can be increased, for ex le identifying alternative delivery formats to increase adherence and reduce dropout, and pursuing novel methods to assess intervention fidelity and quality. This study is registered as PROSPERO CRD42017078690. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 9. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 08-2021
DOI: 10.1136/BMJOPEN-2021-052598
Abstract: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. A prospective, single-blind, two-arm randomised controlled superiority trial. 14 National Health Service physiotherapy departments in the UK. 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4–7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2–6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points 95% CI −0.89 to 1.88 p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months. There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. ISRCTN13517704 .
Publisher: Elsevier BV
Date: 12-2020
Publisher: John Wiley & Sons, Ltd
Date: 23-04-2008
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2008
DOI: 10.1016/J.PAIN.2007.04.035
Abstract: This systematic literature review aims to assess the prognostic value of psychological factors in the development of late whiplash syndrome (LWS). We included prospective cohort studies that provided a baseline measure of at least one psychological variable and used outcome measures relating to LWS (i.e. pain or disability persisting 6 months post injury). A search of electronic databases (Pubmed, Medline, Cinahl, Embase and Psychinfo) up to August 2006 was done using a predetermined search strategy. Methodological quality was assessed independently by two assessors. Data extraction were carried out using a standardised data extraction form. Twenty-five articles representing data from 17 cohorts were included. Fourteen articles were rated as low quality with 11 rated as adequate quality. Meta-analysis was not undertaken due to the heterogeneity of prognostic factors, outcome measures and methods used. Results were tabulated and predefined criterion applied to rate the overall strength of evidence for associations between psychological factors and LWS. Data on 21 possible psychological risk factors were included. The majority of findings were inconclusive. Limited evidence was found to support an association between lower self-efficacy and greater post-traumatic stress with the development of LWS. No association was found between the development of LWS and personality traits, general psychological distress, wellbeing, social support, life control and psychosocial work factors. The lack of conclusive findings and poor methodological quality of the studies reviewed highlights the need for better quality research. Self-efficacy and post-traumatic distress may be associated with the development of LWS but this needs further investigation.
Publisher: National Institute for Health and Care Research
Date: 04-2021
DOI: 10.3310/HTA25250
Abstract: Adrenaline has been used as a treatment for cardiac arrest for many years, despite uncertainty about its effects on long-term outcomes and concerns that it may cause worse neurological outcomes. The objectives were to evaluate the effects of adrenaline on survival and neurological outcomes, and to assess the cost-effectiveness of adrenaline use. This was a pragmatic, randomised, allocation-concealed, placebo-controlled, parallel-group superiority trial and economic evaluation. Costs are expressed in Great British pounds and reported in 2016/17 prices. This trial was set in five NHS ambulance services in England and Wales. Adults treated for an out-of-hospital cardiac arrest were included. Patients were ineligible if they were pregnant, if they were aged 16 years, if the cardiac arrest had been caused by anaphylaxis or life-threatening asthma, or if adrenaline had already been given. Participants were randomised to either adrenaline (1 mg) or placebo in a 1 : 1 allocation ratio by the opening of allocation-concealed treatment packs. The primary outcome was survival to 30 days. The secondary outcomes were survival to hospital admission, survival to hospital discharge, survival at 3, 6 and 12 months, neurological outcomes and health-related quality of life through to 6 months. The economic evaluation assessed the incremental cost per quality-adjusted life-year gained from the perspective of the NHS and Personal Social Services. Participants, clinical teams and those assessing patient outcomes were masked to the treatment allocation. From December 2014 to October 2017, 8014 participants were assigned to the adrenaline ( n = 4015) or to the placebo ( n = 3999) arm. At 30 days, 130 out of 4012 participants (3.2%) in the adrenaline arm and 94 out of 3995 (2.4%) in the placebo arm were alive (adjusted odds ratio for survival 1.47, 95% confidence interval 1.09 to 1.97). For secondary outcomes, survival to hospital admission was higher for those receiving adrenaline than for those receiving placebo (23.6% vs. 8.0% adjusted odds ratio 3.83, 95% confidence interval 3.30 to 4.43). The rate of favourable neurological outcome at hospital discharge was not significantly different between the arms (2.2% vs. 1.9% adjusted odds ratio 1.19, 95% confidence interval 0.85 to 1.68). The pattern of improved survival but no significant improvement in neurological outcomes continued through to 6 months. By 12 months, survival in the adrenaline arm was 2.7%, compared with 2.0% in the placebo arm (adjusted odds ratio 1.38, 95% confidence interval 1.00 to 1.92). An adjusted subgroup analysis did not identify significant interactions. The incremental cost-effectiveness ratio for adrenaline was estimated at £1,693,003 per quality-adjusted life-year gained over the first 6 months after the cardiac arrest event and £81,070 per quality-adjusted life-year gained over the lifetime of survivors. Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest. The estimate for survival with a favourable neurological outcome is imprecise because of the small numbers of patients surviving with a good outcome. Adrenaline improved long-term survival, but there was no evidence that it significantly improved neurological outcomes. The incremental cost-effectiveness ratio per quality-adjusted life-year exceeds the threshold of £20,000–30,000 per quality-adjusted life-year usually supported by the NHS. Further research is required to better understand patients’ preferences in relation to survival and neurological outcomes after out-of-hospital cardiac arrest and to aid interpretation of the trial findings from a patient and public perspective. Current Controlled Trials ISRCTN73485024 and EudraCT 2014-000792-11. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 25. See the NIHR Journals Library website for further project information.
Publisher: JMIR Publications Inc.
Date: 23-03-2023
DOI: 10.2196/43537
Abstract: Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies’ risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a s le of diet- and nutrition-related RCTs the second will include a s le of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random s les of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field. DERR1-10.2196/43537
Publisher: Springer Science and Business Media LLC
Date: 26-01-2007
Publisher: Wiley
Date: 04-11-2016
Publisher: BMJ
Date: 10-11-2021
Abstract: To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. 17 UK National Health Service cancer centres. 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132) 23.7 (22.9) usual care (n=138) adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44 P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale −0.68, −1.23 to −0.12 P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) −2.02, −3.11 to −0.93 P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average −£387 (€457 $533) (95% confidence interval −£2491 to £1718 2015 pricing) and was cost effective compared with usual care. The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. ISRCTN Registry ISRCTN35358984 .
Publisher: Elsevier BV
Date: 10-2021
Publisher: SAGE Publications
Date: 2020
Abstract: To estimate synergistic effects of hip/knee osteoarthritis (OA) and comorbidities on mobility or self-care limitations among older adults. We used baseline, cross-sectional data from the Oxford Pain, Activity and Lifestyle (OPAL) study. Participants were community-dwelling adults aged 65 years or older who completed a postal questionnaire. Participants reported demographic information, hip/knee OA, comorbidities and mobility and self-care limitations. We used modified Poisson regression models to estimate the independent and combined relative risks (RR) of mobility or self-care limitations, the relative excess risk due to interaction (RERI) between hip/knee OA and comorbidities, attributable proportion of the risk due to the interaction and the ratio of the combined effect and the sum of the in idual effects, known as the synergy index. Of the 4,972 participants included, 1,532 (30.8%) had hip/knee OA, and of them 42.9% reported mobility limitations and 8.4% reported self-care limitations. Synergistic effects impacting self-care limitations were observed between hip/knee OA and anxiety (RR: 3.09, 95% Confidence Interval (CI): 2.00 to 4.78 RERI: 0.93, 95% CI: 0.01 to 1.90), and between hip/knee OA and depressive symptoms (RR: 2.71, 95% CI: 1.75 to 4.20 RERI: 0.58, 95% CI: 0.03 to 1.48). The portion of the total RR attributable to this synergism was 30% and 22% respectively. This study demonstrates that synergism between hip/knee OA and anxiety or depressive symptoms contribute to self-care limitations. These findings highlight the importance of assessing and addressing anxiety or depressive symptoms when managing older adults with hip/knee OA to minimize self-care limitations.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-2007
Publisher: Springer Science and Business Media LLC
Date: 03-02-2020
DOI: 10.1186/S12874-020-0915-5
Abstract: There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve the production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. The development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.
Publisher: Wiley
Date: 30-09-2019
DOI: 10.1111/ECI.13169
Publisher: Elsevier BV
Date: 03-2015
DOI: 10.1016/J.PHYSIO.2014.04.004
Abstract: (1) To identify risk factors for chronic disability in people with acute whiplash associated disorders (WAD). (2) To estimate the impact of the numbers of risk factors present. Prospective cohort study. Data were collected, on average, 32 days after injury (SD=10.9) and 12 months later. Baseline measures of pain, disability, neck movement, psychological and behavioural factors were independent variables and chronic disability at 12 months was the dependent variable in a multivariable logistic regression analysis. National Health Service physiotherapy departments. Participants (n=599) with symptoms 3 weeks after injury, self-referred to physiotherapy as part of a randomised controlled trial. 430 (72%) participants provided complete data for this analysis. Chronic disability based on Neck Disability Index scores. 136 (30%) participants developed chronic disability. High baseline disability (OR 3.3, 95% CI 1.97 to 5.55), longer predicted recovery time (OR 2.4, 95% CI 1.45 to 3.87), psychological distress (OR 1.9, 95%CI 1.05 to 3.51), passive coping (OR 1.8, 95% CI 1.07 to 2.97) and greater number of symptoms (OR 1.7, 95% CI 1.07 to 2.78) were associated with chronic disability. One risk factor resulted in 3.5 times the risk (95% CI 1.04 to 11.45) of chronic disability but this risk increased to 16 times (95%CI 5.36 to 49.27) in those with four or five risk factors. Baseline disability had the strongest association with chronic disability but psychological and behavioural factors were also important. Treatment strategies should reflect this which may require a change to current physiotherapy approaches for acute WAD. The number of risk factors present should be considered when evaluating potential for poor outcome.
Publisher: JMIR Publications Inc.
Date: 27-06-2018
DOI: 10.2196/10457
Publisher: Springer Science and Business Media LLC
Date: 23-08-2019
Publisher: National Institute for Health and Care Research
Date: 07-2015
DOI: 10.3310/HTA19550
Abstract: The feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain. The aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites (4) develop, document and assess acceptability and adherence of interventions (5) assess and describe training requirements of physiotherapists and (6) gain user input in all relevant stages of treatment and protocol design. Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial. The randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS. The randomised feasibility study recruited people aged 10–16 years with mild AIS (Cobb angle of 50°). The randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS. The main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities. A UK survey of orthopaedic consultants and physiotherapists indicated a wide variation in current provision of exercise therapy through physiotherapy services. It also found that clinicians from at least 15 centres would be willing to have their patients involved in a full study. A systematic review update found five new studies that were generally of low quality but showed some promise of effectiveness of SSE. The randomised study recruited 58 patients from four NHS trusts over 11 months and exceeded the pre-specified target recruitment rate of 1.4 participants per centre per month, with acceptable 6-month follow-up (currently 73%). Adherence to treatment was variable (56% of participants completed treatment offered). The qualitative study found the exercise programme to be highly acceptable. We learnt important lessons from patient and public involvement during the study in terms of study and intervention presentation, as well as practical elements such as scheduling of intervention sessions. A definitive RCT evaluating clinical effectiveness and cost-effectiveness of SSE for idiopathic scoliosis is warranted and feasible. Such a RCT is a priority for future work in the area. There is a sufficiently large patient base, combined with willingness to be randomised within specialist UK centres. Interventions developed during the feasibility study were acceptable to patients, families and physiotherapists and can be given within the affordability envelope of current levels of physiotherapy commissioning. Current Controlled Trials ISRCTN90480705. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 55. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 05-2019
DOI: 10.1136/BMJOPEN-2018-028160
Abstract: The effectiveness of complex interventions for the management of musculoskeletal disorders has been estimated in many randomised clinical trials (RCTs). These trials inform which interventions are the most effective, however they do not always inform how an intervention achieved its clinical outcomes, nor how and what elements of an intervention were delivered to patients. Such information is useful for translating findings into clinical practice. A few process evaluation studies have been conducted alongside RCTs and a variety of methods have been used. To gain a better understanding of current practices of process evaluation in RCTs in musculoskeletal disorders, this systematic review is designed to answer the following research question: How are process evaluation of complex interventions tested in RCTs in musculoskeletal disorders being conducted? We will systematically search seven electronic databases (MEDLINE, SCOPUS, CINAHL, PsycINFO, EMBASE, Web of Science and Cochrane database) from the date of inception to August 2018 for studies on process evaluation of RCTs on non-surgical and non-pharmacological management of musculoskeletal disorders. We will include qualitative and quantitative studies conducted alongside RCTs, reported with the RCTs or separate studies that assessed interventions for musculoskeletal disorders. Two reviewers will screen abstracts and apply prespecified inclusion criteria to identify relevant studies, extract the data and assess the risk of bias within included studies. We will follow recommendations from the ‘Cochrane Qualitative and Implementation Methods Group Guidance Series’ when assessing methodological strengths and limitations of included studies. We will use a narrative synthesis to describe findings. Ethical approval is not required as this review will not collect original data. Findings from this systematic review will be presented at a scientific conference and published in a peer reviewed journal. CRD42018109600
Publisher: Wiley
Date: 17-11-2020
DOI: 10.1002/MSC.1526
Abstract: Musculoskeletal (MSK) pain is common in older adults. Physical and psychological consequences of MSK pain have been established, but it is also important to consider the social impact. We aimed to estimate the association between MSK pain and loneliness, social support and social engagement. We used baseline data from the Oxford Pain, Activity and Lifestyle study. Participants were community‐dwelling adults aged 65 years or older from across England. Participants reported demographic information, MSK pain by body site, loneliness, social support and social engagement. We categorised pain by body regions affected (upper limb, lower limb and spinal). Widespread pain was defined as pain in all three regions. We used logistic regression models to estimate associations between distribution of pain and social factors, controlling for covariates. Of the 4977 participants analysed, 4193 (84.2%) reported any MSK pain, and one‐quarter ( n = 1298) reported widespread pain. In iduals reporting any pain were more likely to report loneliness (OR [odds ratio]: 1.62 95% CI [confidence interval]: 1.32–1.97) or insufficient social support (OR: 1.54 95% CI: 1.08–2.19) compared to those reporting no pain. Widespread pain had the strongest association with loneliness (OR: 1.94 95% CI: 1.53–2.46) and insufficient social support (OR: 1.71 95% CI: 1.14–2.54). Pain was not associated with social engagement. Older adults commonly report MSK pain, which is associated with loneliness and perceived insufficiency of social support. This finding highlights to clinicians and researchers the need to consider social implications of MSK pain in addition to physical and psychological consequences.
Publisher: Elsevier BV
Date: 06-2019
DOI: 10.1016/J.PHYSIO.2018.10.004
Abstract: Systematic review and meta-analysis. To assess the effectiveness of scoliosis-specific exercises (SSE) on adolescent idiopathic scoliosis (AIS) compared with other non-surgical interventions. AIS is a complex deformity of the spine that develops between the age of 10years and skeletal maturity. SSE are prescribed to patients to reduce or slow curve progression, although their effectiveness is unknown. Electronic databases were searched for relevant studies. Randomised controlled trials were eligible if they compared SSE with non-surgical interventions for in iduals with AIS. Three authors independently extracted data, evaluated methodological quality and assessed the quality of evidence. Meta-analysis was performed where possible otherwise, descriptive syntheses are reported. Nine randomised controlled trials were included. Four had a high risk of bias, three had an unclear risk and two had a low risk. Very-low-quality evidence indicated that SSE improved some measures of spinal deformity, function, pain and overall health-related quality of life (HRQoL). Very-low-quality evidence suggested that SSE had no effect on self-image and mental health. Very-low-quality evidence showed that bracing was more effective than SSE on measures of spinal deformity. However, SSE showed greater improvements in function, HRQoL, self-image, mental health and patient satisfaction with treatment. No differences were found for pain or trunk rotation. SSE may be effective for improving measures of spinal deformity for people with AIS, but the evidence is of very low quality. Future studies should evaluate relevant clinical measures and cost-effectiveness using rigorous methods and reporting standards.
Publisher: BMJ
Date: 21-08-2009
Abstract: To undertake a national survey to determine current practice for the management of whiplash injuries in UK emergency departments (ED). Postal questionnaire survey. 316 lead consultants from all UK ED with annual new attendances of over 50 000 people were asked to indicate the use of a range of treatments and the frequency with which these treatments were used. S les of written advice were requested and content analysis was conducted and compared with survey responses. The response rate was 79% (251/316). The intervention most frequently used was verbal advice to exercise, reported by 84% of respondents for most or all cases, and advice against the use of a collar (83%). Other treatments reported as being used frequently were written advice and anti-inflammatory medication. 106 consultants (42%) provided a s le of written materials. Reference to expected recovery and encouragement for early return to activities were included in less than 6%. Nearly 50% of written materials contained information on how to use a soft collar and 61% contained information on solicitors and pursuing a personal injury claim. There were important differences between reported verbal behaviours and written advice. Verbal advice is the primary method for managing whiplash injuries in ED and is usually supplemented by written advice. Within in idual hospitals there is a lack of consistency between verbal and written advice. The promotion of personal injury claims is a common feature of written advice. Research is required to develop effective and consistent models of advice.
Publisher: Springer Science and Business Media LLC
Date: 25-03-2016
Publisher: BMJ
Date: 09-2020
DOI: 10.1136/BMJOPEN-2020-037121
Abstract: Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme). We will use causal mediation analysis to estimate the mechanistic effects of the BOOST programme on the primary outcome of disability (measured by the Oswestry Disability Index). The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity. All mediators will be measured at 6 months and the outcome will be measured at 12 months from randomisation. Patient characteristics and possible confounders of the mediator-outcome effect will be measured at baseline. Sensitivity analyses will be conducted to evaluate the robustness of the estimated effects to varying levels of residual confounding. Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). The results of this analysis will be disseminated in peer-reviewed journals and at relevant scientific conferences. ISRCTN12698674 .
Publisher: Informa UK Limited
Date: 23-05-2017
DOI: 10.1080/09638288.2016.1177611
Abstract: The aim of this study was to explore older people's experiences of living with neurogenic claudication (NC), their preferences for physiotherapy treatment provision and associated outcomes in order to inform an intervention to be tested in a clinical trial. Patients with a diagnosis of NC and/or lumbar spinal stenosis were recruited through a UK NHS tertiary care center. Semi-structured interviews and self-report questionnaires were used to obtain data. A thematic analysis was conducted. 15 participants were recruited half were classed as frail older adults. Pain and the threat of pain was a prominent feature of participants' experience of NC. This led to a loss of engagement in meaningful activities and sense of self. Discourses of ageing influenced experiences as well as treatment preferences, particularly the acceptability of walking aids. A combination of one-to-one and group setting for treatment was preferred. Outcome preferences related to re-engagement in meaningful activities and pain reduction. Limitations relate to generalisability of the findings for NC patients not under physiotherapy treatment. We have obtained important findings about older people's experiences of living with NC and preferences for physiotherapy treatment and outcomes. These will be incorporated into an evidence-based intervention and evaluated in a randomized controlled trial. Implications for rehabilitation Older people living with NC want to get back to meaningful activities and learn how to live with the threat of pain. Allied health professionals (AHPs) should be sensitive to the complex and ambiguous ways in which older people live with ageing and age-related decline. AHPs are in a position to support patients' successful transition to the use of walking aids thereby reducing stigmatizing effects and increasing activity. AHPs should consider a mixture of one-to-one and group classes to enable rehabilitation for older NC patients.
Publisher: BMJ
Date: 26-08-2020
DOI: 10.1136/BMJEBM-2020-111406
Abstract: Mediation analysis is a widely used quantitative method for investigating how interventions and exposures in randomised controlled trials and observational studies have an effect on healthcare outcomes. This study aimed to assess the importance of items that should be considered in a consensus meeting aimed at developing a guideline for reporting mediation analyses. International online Delphi study. International experts in the development and application of mediation analysis. The Delphi panel were asked to rate the importance of a list of items for inclusion in a guideline for reporting mediation analyses. Thresholds for disagreement and consensus on importance for inclusion were specified a priori. We used the Research ANd Development/University of California Los Angeles appropriateness method to quantitatively assess the importance for inclusion and panel agreement. Nineteen expert panellists (10 female) from seven countries agreed to participate. All panellists contributed to all three rounds conducted between 10 June 2019 and 6 November 2019. The panel reached consensus on 34 unique reporting items for study design, analytic procedures and effect estimates, with three items rated ‘optional’. Panellists added one extra item and provided 60 qualitative comments for item refinement and prioritisation. This Delphi study used a rigorous consensus process to reach consensus on 34 reporting items for studies that use mediation analysis. These results will inform a consensus meeting that will consolidate a core set of recommended items for reporting mediation analyses.
Publisher: Elsevier BV
Date: 07-2019
DOI: 10.1016/J.JCLINEPI.2019.03.005
Abstract: The objective of this study was to investigate whether systematic reviews of mediation studies identify limitations in reporting quality and methodological conduct. We conducted an overview of systematic reviews. We searched four databases (MEDLINE, PsycINFO, Cochrane Database of Systematic Reviews, and PubMed) to identify systematic reviews of studies that used mediation analysis to investigate mechanisms of health care interventions or exposures in clinical populations between 2007 and 2017. Two reviewers independently screened titles and abstracts. Summary data on the characteristics, reporting quality, and methodological conduct of the studies included in the systematic reviews were extracted independently by two reviewers. The protocol was prospectively registered on PROSPERO (CRD42017059834). Fifty-four systematic reviews were included, representing 11 health care fields, 26 health conditions, and 2008 mediation studies. Eighteen of fifty-four systematic reviews (33%) explicitly stated that the reporting of primary studies was suboptimal. Of these, 14/18 (78%) reviews noted incomplete reporting of effect sizes and precision estimates from mediation analyses. Twenty-nine of fifty-four systematic reviews (54%) identified limitations in the methodological conduct of primary studies. The reporting and methodological conduct of studies investigating mechanisms in health care seems to be suboptimal. Guidance is needed to improve the quality, completeness, and transparency of mediation studies.
Publisher: Wiley
Date: 16-05-2022
DOI: 10.1002/MSC.1646
Abstract: 1) To identify therapist or participant characteristics associated with prescribed dose of hand strengthening exercise in adults with rheumatoid arthritis and 2) To determine the impact of dose prescribed on outcome (hand function and grip strength). Overall dose was calculated using area under the curve (AUC). Analysis 1 assessed the association between therapist professional background, therapist grade, baseline participant physical and psychological characteristics and prescribed dose. Analyses 2 and 3 estimated the relationship between prescribed dose and overall hand function and grip strength. Generalised estimating equation linear regression analysis was used. Analysis 1: Being treated by an occupational therapist ( β = −297.0, 95% CI −398.6, −195.4), metacarpophalangeal joint deformity ( β = −24.1, 95% CI −42.3, −5.9), a higher number of swollen wrist/hand joints ( β = −11.4, 95% CI −21.6, −1.2) and the participant feeling downhearted and low all of the time ( β = −293.6, 95% CI −436.1, −151.1) were associated with being prescribed a lower dose. Being treated by a grade 6 therapist ( β = 159.1, 95% CI 65.7, 252.5), higher baseline grip strength ( β = 0.15, 95% CI 0.02, 0.28) and greater participant confidence to exercise without fear of making symptoms worse ( β = 18.9, 95% CI 1.5, 36.3) were associated with being prescribed a higher dose. Analyses 2 and 3: Higher dose was associated with greater overall hand function ( β = 0.005, 95% CI 0.001, 0.010) and full‐hand grip strength ( β = 0.014, 95% CI 0.000, 0.025) at 4‐month. Higher dose was associated with better clinical outcomes. Prescription of hand strengthening exercise is associated with both therapist and participant characteristics.
Publisher: National Institute for Health and Care Research
Date: 04-2017
DOI: 10.3310/HTA21240
Abstract: Falls are a serious cause of morbidity and cost to in iduals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness. To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care. A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study. Nine NHS trusts in the UK and one site in Ireland. In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493 usual care, n = 517) via a secure, remote service. Blinding was not possible. All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises. The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness. The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05 p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00 p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants. Owing to the difficulty in calculating a s le size for a count outcome, the s le size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care. The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective. Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients. Current Controlled Trials ISRCTN68240461. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 21, No. 24. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 06-2015
DOI: 10.1016/J.PHYSIO.2014.06.001
Abstract: Beliefs held by patients have been shown to influence outcomes in acute whiplash associated disorders (WAD). The aim was to identify beliefs about pain and recovery present in the narratives of in iduals with WAD and to understand how and why in iduals' came to hold these beliefs. A qualitative study. Interpretative Phenomenological Analysis of semi-structured interviews. Participants (n=20) were enrolled in a large, pragmatic randomised controlled trial of physiotherapy for acute WAD. Participants were interviewed after they completed their treatment. A range of beliefs were evident. These included beliefs about exercise and activity, ability to self-manage symptoms, expectations of recovery and competing priorities. Some beliefs appeared to be barriers to recovery despite all participants having consulted several health professionals. Health professionals were highly influential over how in iduals' thought about and managed their injury. The pain experienced influenced how in iduals thought and behaved as did past experiences of injury and illness. Competing priorities were a potential barrier to engaging with treatment. We identified ex les of how beliefs and behaviour changed in response to information from health professionals and the pain they experienced. People with WAD hold a range of beliefs about pain and recovery and some appear unhelpful to recovery. Health professionals can influence these beliefs and encourage behaviours that aid recovery. Understanding how patients form beliefs may help health professionals to address unhelpful beliefs. It is important that advice and education provided is in line with the current evidenced based understanding of pain and recovery.
Publisher: SAGE Publications
Date: 20-08-2016
Abstract: Using an ex le of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan.
Publisher: Public Library of Science (PLoS)
Date: 21-09-2020
Publisher: S. Karger AG
Date: 2018
DOI: 10.1159/000489171
Abstract: b i Background: /i /b Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. b i Objective: /i /b To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. b i Methods: /i /b REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland 1,010 participants (& #x3e 65 years) were randomised to receive either a podiatry intervention ( i n /i = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet ( i n /i = 517). Primary outcome: incidence of falls per participant in the 12 months following randomisation. Secondary outcomes: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. b i Results: /i /b There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73–1.05, i /i = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI –0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP –69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. b i Conclusion: /i /b The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.
Publisher: BMJ
Date: 16-05-2018
DOI: 10.1136/BMJ.K1675
Abstract: To estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia. Multicentre, pragmatic, investigator masked, randomised controlled trial. National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions. 494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm. Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises. The primary outcome was score on the Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention. The average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference -1.4, 95% confidence interval -2.6 to -0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer's disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m). A moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes. Current Controlled Trials ISRCTN10416500.
Publisher: National Institute for Health and Care Research
Date: 05-2018
DOI: 10.3310/HTA22280
Abstract: Approximately 670,000 people in the UK have dementia. Previous literature suggests that physical exercise could slow dementia symptom progression. To estimate the clinical effectiveness and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD) and carer burden and HRQoL. Intervention development, systematic review, multicentred, randomised controlled trial (RCT) with a parallel economic evaluation and qualitative study. 15 English regions. People with MMD living in the community. A 4-month moderate- to high-intensity, structured exercise programme designed specifically for people with MMD, with support to continue unsupervised physical activity thereafter. Exercises were in idually prescribed and progressed, and participants were supervised in groups. The comparator was usual practice. The primary outcome was the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog). The secondary outcomes were function [as measured using the Bristol Activities of Daily Living Scale (BADLS)], generic HRQoL [as measured using the EuroQol-5 Dimensions, three-level version (EQ-5D-3L)], dementia-related QoL [as measured using the Quality of Life in Alzheimer’s Disease (QoL-AD) scale], behavioural symptoms [as measured using the Neuropsychiatric Inventory (NPI)], falls and fractures, physical fitness (as measured using the 6-minute walk test) and muscle strength. Carer outcomes were HRQoL (Quality of Life in Alzheimer’s Disease) (as measured using the EQ-5D-3L) and carer burden (as measured using the Zarit Burden Interview). The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained from a NHS and Personal Social Services perspective. We measured health and social care use with the Client Services Receipt Inventory. Participants were followed up for 12 months. Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care and 329 to the intervention. The mean age of participants was 77 years [standard deviation (SD) 7.9 years], 39% (193/494) were female and the mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates, with 65% (214/329) attending between 75% and 100% of sessions. Outcome data were obtained for 85% (418/494) of participants at 12 months, at which point a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), with a mean difference of –1.4 [95% confidence interval (CI) –2.62 to –0.17]. There were no treatment effects for any of the other secondary outcome measures for participants or carers: for the BADLS there was a mean difference of –0.6 (95% CI –2.05 to 0.78), for the EQ-5D-3L a mean difference of –0.002 (95% CI –0.04 to 0.04), for the QoL-AD scale a mean difference of 0.7 (95% CI –0.21 to 1.65) and for the NPI a mean difference of –2.1 (95% CI –4.83 to 0.65). Four serious adverse events were reported. The exercise intervention was dominated in health economic terms. In the absence of definitive guidance and rationale, we used a mixed exercise programme. Neither intervention providers nor participants could be masked to treatment allocation. This is a large well-conducted RCT, with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function or HRQoL in people with dementia or on carer burden. Future work should concentrate on approaches other than exercise to influence cognitive impairment in dementia. Current Controlled Trials ISRCTN32612072. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full programme and will be published in full in Health Technology Assessment Vol. 22, No. 28. See the NIHR Journals Library website for further project information. Additional funding was provided by the Oxford NIHR Biomedical Research Centre and the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care.
Publisher: Wiley
Date: 24-03-2014
DOI: 10.1111/JEP.12115
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2013
Publisher: Wiley
Date: 31-01-2019
Publisher: Springer Science and Business Media LLC
Date: 28-03-2017
Publisher: Elsevier BV
Date: 06-2012
DOI: 10.1016/J.PHYSIO.2011.03.001
Abstract: This paper describes the development and implementation of a hand exercise intervention for rheumatoid arthritis (RA) as part of a large multi-centred randomised controlled trial in a U.K. National Health Service (NHS) setting. Participants are eligible if diagnosed with RA according to American College of Rheumatology criteria, have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. The intervention development was informed by the current evidence base, published guidelines, clinician and expert opinion, and a pilot study. The exercise programme targets known, potentially modifiable physical impairments of the hand with 5 exercise sessions and a home exercise component over a 12 week period. The intervention will be provided to 240 participants along with usual care. A further 240 will receive usual care only as part of the control arm. Specific details of the treatments delivered are described. [ISRCTN no: 89936343].
Publisher: Elsevier BV
Date: 06-2019
DOI: 10.1016/J.PHYSIO.2019.01.019
Abstract: Neurogenic claudication due to spinal stenosis is a common cause of disability in older adults. Conservative treatments are a favourable treatment option. This paper describes the development and delivery of the BOOST (Better Outcomes for Older adults with Spinal Trouble) intervention, a physiotherapist-delivered physical and psychological intervention for the management of neurogenic claudication in older adults. The BOOST intervention is being tested in a multi-centre, randomised controlled trial in UK National Health Service Trusts delivered by physiotherapists registered with the Health and Care Professionals Council. Participants are aged 65 years or older, registered with a primary care practice, and report symptoms consistent with neurogenic claudication. Intervention content and delivery was initially informed by clinical and patient experts, research evidence, and behaviour change guidelines and refined following an intervention development day attended by researchers, health professionals, and Patient and Public Involvement representatives. The BOOST intervention comprises 12 group sessions, promoting sustained adherence with a long term home and physical activity programme. Each session includes education and group discussion, in idually tailored exercises, and walking. Initial exercise levels are set at a one-to-one assessment. Continued home exercise adherence and increased physical activity following completion of the sessions is facilitated through support telephone calls. Trial registration ISRCTN12698674.
Publisher: Public Library of Science (PLoS)
Date: 29-06-2017
Publisher: Georg Thieme Verlag KG
Date: 03-2016
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2008
End Date: 2009
Funder: Economic and Social Research Council
View Funded Activity