Publications by authors named "Sarah E Lamb"

228 Publications

A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: The AGReMA Statement.

JAMA 2021 Sep;326(11):1045-1056

School of Public Health, University of Sydney, Sydney, Australia.

Importance: Mediation analyses of randomized trials and observational studies can generate evidence about the mechanisms by which interventions and exposures may influence health outcomes. Publications of mediation analyses are increasing, but the quality of their reporting is suboptimal.

Objective: To develop international, consensus-based guidance for the reporting of mediation analyses of randomized trials and observational studies (A Guideline for Reporting Mediation Analyses; AGReMA).

Design, Setting, And Participants: The AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodological framework for developing reporting guidelines. The guideline development process included (1) an overview of systematic reviews to assess the need for a reporting guideline; (2) review of systematic reviews of relevant evidence on reporting mediation analyses; (3) conducting a Delphi survey with panel members that included methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors (n = 19; June-November 2019); (4) having a consensus meeting (n = 15; April 28-29, 2020); and (5) conducting a 4-week external review and pilot test that included methodologists and potential users of AGReMA (n = 21; November 2020).

Results: A previously reported overview of 54 systematic reviews of mediation studies demonstrated the need for a reporting guideline. Thirty-three potential reporting items were identified from 3 systematic reviews of mediation studies. Over 3 rounds, the Delphi panelists ranked the importance of these items, provided 60 qualitative comments for item refinement and prioritization, and suggested new items for consideration. All items were reviewed during a 2-day consensus meeting and participants agreed on a 25-item AGReMA statement for studies in which mediation analyses are the primary focus and a 9-item short-form AGReMA statement for studies in which mediation analyses are a secondary focus. These checklists were externally reviewed and pilot tested by 21 expert methodologists and potential users, which led to minor adjustments and consolidation of the checklists.

Conclusions And Relevance: The AGReMA statement provides recommendations for reporting primary and secondary mediation analyses of randomized trials and observational studies. Improved reporting of studies that use mediation analyses could facilitate peer review and help produce publications that are complete, accurate, transparent, and reproducible.
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http://dx.doi.org/10.1001/jama.2021.14075DOI Listing
September 2021

Research Note: Transporting causal effects from randomised trials to target populations to improve external validity.

J Physiother 2021 Sep 15. Epub 2021 Sep 15.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK; College of Medicine and Health, University of Exeter Medical School, Exeter, UK.

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http://dx.doi.org/10.1016/j.jphys.2021.08.007DOI Listing
September 2021

The Effect of Therapeutic Exercise Interventions on Physical and Psychosocial Outcomes in Adults Aged 80 Years and Older: A Systematic Review and Meta-Analysis.

J Aging Phys Act 2021 Sep 6:1-18. Epub 2021 Sep 6.

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]; I2: 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]; I2: 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]; I2: 0.0%; six RCTs; 1,222 participants; low-quality evidence).
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http://dx.doi.org/10.1123/japa.2021-0149DOI Listing
September 2021

Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.

Health Technol Assess 2021 Aug;25(48):1-158

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: Rotator cuff-related shoulder pain is very common, but there is uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits of corticosteroid injections.

Objectives: To assess the clinical effectiveness and cost-effectiveness of progressive exercise compared with best-practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Design: This was a pragmatic multicentre superiority randomised controlled trial (with a 2 × 2 factorial design).

Setting: Twenty NHS primary care-based musculoskeletal and related physiotherapy services.

Participants: Adults aged ≥ 18 years with a new episode of rotator cuff-related shoulder pain in the previous 6 months.

Interventions: A total of 708 participants were randomised (March 2017-May 2019) by a centralised computer-generated 1 : 1 : 1 : 1 allocation ratio to one of four interventions: (1) progressive exercise ( = 174) (six or fewer physiotherapy sessions), (2) best-practice advice ( = 174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise ( = 182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice ( = 178) (one physiotherapy session).

Main Outcome Measures: The primary outcome was Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes included SPADI subdomains, the EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, pain self-efficacy, return to activity, Global Impression of Treatment and health resource use. Outcomes were collected by postal questionnaires at 8 weeks and at 6 and 12 months. A within-trial economic evaluation was also conducted. The primary analysis was intention to treat.

Results: Participants had a mean age of 55.5 (standard deviation 13.1) years and 49.3% were female. The mean baseline SPADI score was 54.1 (standard deviation 18.5). Follow-up rates were 91% at 8 weeks and 87% at 6 and 12 months. There was an overall improvement in SPADI score from baseline in each group over time. Over 12 months, there was no evidence of a difference in the SPADI scores between the progressive exercise intervention and the best-practice advice intervention in shoulder pain and function (adjusted mean difference between groups over 12 months -0.66, 99% confidence interval -4.52 to 3.20). There was also no difference in SPADI scores between the progressive exercise intervention and best-practice advice intervention when analysed at the 8-week and 6- and 12-month time points. Injection resulted in improvement in shoulder pain and function at 8 weeks compared with no injection (adjusted mean difference -5.64, 99% confidence interval -9.93 to -1.35), but not when analysed over 12 months (adjusted mean difference -1.11, 99% confidence interval -4.47 to 2.26), or at 6 and 12 months. There were no serious adverse events. In the base-case analysis, adding injection to best-practice advice gained 0.021 quality-adjusted life-years ( = 0.184) and increased the cost by £10 per participant ( = 0.747). Progressive exercise alone was £52 ( = 0.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs ( = 0.220). At a ceiling ratio of £20,000 per quality-adjusted life-year, injection plus best-practice advice had a 54.93% probability of being the most cost-effective treatment.

Limitations: Participants and physiotherapists were not blinded to group allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns.

Conclusions: Progressive exercise was not superior to a best-practice advice session with a physiotherapist. Subacromial corticosteroid injection improved shoulder pain and function, but provided only modest short-term benefit. Best-practice advice in combination with corticosteroid injection was expected to be most cost-effective, although there was substantial uncertainty.

Future Work: Longer-term follow-up, including any serious adverse effects of corticosteroid injection.

Trial Registration: Current Controlled Trials ISRCTN16539266 and EudraCT 2016-002991-28.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25480DOI Listing
August 2021

Risk Factors for Mobility Decline in Community-Dwelling Older Adults: A Systematic Literature Review.

J Aging Phys Act 2021 Aug 4:1-14. Epub 2021 Aug 4.

Mobility is essential to maintaining independence for older adults. This systematic review aimed to summarize evidence about self-reported risk factors for self-reported mobility decline; and to provide an overview of published prognostic models for self-reported mobility decline among community-dwelling older adults. Databases were searched from inception to June 2, 2020. Studies were screened by two independent reviewers who extracted data and assessed study quality. Sixty-one studies (45,187 participants) were included, providing information on 107 risk factors. High-quality evidence and moderate/large effect sizes for the association with mobility decline were found for older age beyond 75 years, the presence of widespread pain, and mobility modifications. Moderate-high quality evidence and small effect sizes were found for a further 21 factors. Three model development studies demonstrated acceptable model performance, limited by high risk of bias. These findings should be considered in intervention development, and in developing a prediction instrument for practical application.
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http://dx.doi.org/10.1123/japa.2020-0482DOI Listing
August 2021

Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.

Lancet 2021 07 12;398(10298):416-428. Epub 2021 Jul 12.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; College of Medicine and Health, University of Exeter, Exeter, UK.

Background: Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Methods: In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28.

Findings: Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference -0·66 [99% CI -4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (-1·11 [-4·47 to 2·26]). No serious adverse events were reported.

Interpretation: Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders.

Funding: UK National Institute for Health Research Technology Assessment Programme.
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http://dx.doi.org/10.1016/S0140-6736(21)00846-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343092PMC
July 2021

Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.

Health Technol Assess 2021 Jul;25(46):1-118

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Background: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals 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.

Objective: 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.

Design: This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study.

Setting: Eight NHS trusts in primary and secondary care in England.

Participants: In total, 1331 participants were randomised (intervention group,  = 430; usual-care group,  = 901) via a secure, remote service. Blinding was not possible.

Interventions: 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.

Main Outcome Measures: 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.

Results: 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;  = 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.

Limitations: Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data.

Conclusions: 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.

Future Work: 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.

Trial Registration: Current Controlled Trials ISRCTN22202133.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 46. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287374PMC
July 2021

Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial.

Pilot Feasibility Stud 2021 Jun 24;7(1):133. Epub 2021 Jun 24.

Centre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.

Background: Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design.

Methods: This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60-90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study.

Discussion: Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference.

Trial Registration: ISRCTN12196200 registered on 15 January 2019.
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http://dx.doi.org/10.1186/s40814-021-00869-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8223359PMC
June 2021

Getting Recovery Right After Neck Dissection (GRRAND-F): mixed-methods feasibility study to design a pragmatic randomised controlled trial protocol.

BMJ Open 2021 06 21;11(6):e045741. Epub 2021 Jun 21.

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, Oxfordshire, UK

Introduction: We will evaluate the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention on pain, function and health-related quality of life following neck dissection (ND) after head and neck cancer (HNC).

Methods And Analysis: This is a pragmatic, multicentred, feasibility study. Participants are randomised to usual care (control) or usual care plus an individualised, rehabilitation programme (Getting Recovery Right After Neck Dissection, GRRAND intervention). Adults aged over 18 with HNC for whom ND is part of their care will be recruited from specialist clinics. Participants are randomised in 1:1 ratio using a web-based service. The target sample size is 60 participants. Usual care will be received by all participants during their postoperative inpatient stay consisting standard National Health Service care supplemented with a booklet advising on postoperative self-management strategies. The GRRAND intervention programme consists of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion (ROM) and progressive resistance exercises, advice and education. Between sessions participants will be advised to complete a home exercise programme. The primary outcome is to determine recruitment and retention rates from study participants across sites. Outcomes will be measured at 6 and 12 months. Participants and physiotherapists will be invited to an optional qualitative interview at the completion of their involvement in the study. The target qualitative sample size is 15 participants and 12 physiotherapists. Interviews aim to further investigate the feasibility and acceptability of the intervention and to determine wider experiences of the study design and intervention from patient and physiotherapist perspectives.

Ethics And Dissemination: Ethical approval was given on 29 October 2019 (National Research Ethics Committee Number: 19/SC/0457). Results will be reported at conferences and in peer-reviewed publications.

Trial Registration Number: ISRCTN11979997.

Status: Trial recruitment is ongoing and is expected to be completed by 30 August 2021.
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http://dx.doi.org/10.1136/bmjopen-2020-045741DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8217923PMC
June 2021

Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT.

Health Technol Assess 2021 May;25(34):1-114

Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.

Background: Falls and fractures are a major problem.

Objectives: To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions.

Design: Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice.

Setting: Primary care.

Participants: People aged ≥ 70 years.

Interventions: All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling.

Main Outcome Measures: The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit.

Results: Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported.

Limitations: The rate of fractures was lower than anticipated.

Conclusions: Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective.

Future Work: Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects.

Trial Registration: Current Controlled Trials ISRCTN71002650.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 34. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8200932PMC
May 2021

Psychometric Properties of the Proxy-Reported Life-Space Assessment in Institutionalized Settings (LSA-IS-Proxy) for Older Persons with and without Cognitive Impairment.

Int J Environ Res Public Health 2021 04 7;18(8). Epub 2021 Apr 7.

Agaplesion Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, and Center of Geriatric Medicine, Heidelberg University, 69126 Heidelberg, Germany.

(1) Background: Life-space mobility assessments for institutionalized settings are scarce and there is a lack of comprehensive validation and focus on persons with cognitive impairment (CI). This study aims to evaluate the psychometric properties of the Life-Space Assessment for Institutionalized Settings by proxy informants (LSA-IS-proxy) for institutionalized, older persons, with and without CI. (2) Methods: Concurrent validity against the self-reported version of the LSA-IS, construct validity with established construct variables, test-retest reliability, sensitivity to change during early multidisciplinary geriatric rehabilitation treatment, and feasibility (completion rate, floor/ceiling effects) of the LSA-IS-proxy, were assessed in 94 hospitalized geriatric patients (83.3 ± 6.1 years), with and without CI. (3) Results: The LSA-IS-proxy total score showed good-to-excellent agreement with the self-reported LSA-IS (Intraclass Correlations Coefficient, ICC = 0.77), predominantly expected small-to-high correlations with construct variables ( = 0.21-0.59), good test-retest reliability (ICC = 0.74), significant sensitivity to change over the treatment period (18.5 ± 7.9 days; < 0.001, standardized response mean = 0.44), and excellent completion rates (100%) with no floor/ceiling effects. These results were predominantly confirmed for the sub-scores of the LSA-IS-proxy and were comparable between the sub-groups with different cognitive status. (4) Conclusions: The LSA-IS-proxy has proven to be feasible, valid, reliable, and sensitive to change in hospitalized, geriatric patients with and without CI.
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http://dx.doi.org/10.3390/ijerph18083872DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067867PMC
April 2021

A hand exercise mobile app for people with rheumatoid arthritis in Turkey: design, development and usability study.

Rheumatol Int 2021 Jun 18;41(6):1151-1160. Epub 2021 Apr 18.

Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.

To design and develop a smartphone application for a structured hand exercise programme for patients with rheumatoid arthritis (RA) in Turkey and to test its usability. We followed a two-stage process: (1) Design and Development and (2) Usability testing. In stage 1, we used a qualitative user-centered design approach. We conducted a focus group (8 therapists and people with RA) to discuss the content, features and design to produce a prototype of the application. In a second focus group session, the participants tested the prototype, provided feedback and further revisions were made. In stage 2, 17 participants with RA used the app for 4 to 6 weeks. The System Usability Scale and the adapted Usability, Satisfaction and Ease to Use Questionnaires were used to measure usability, ease of use. Semi-structured interviews were conducted to explore user experiences with the application with 17 participants. In stage 1, the following themes were identified from the focus groups (a) login techniques (b) self-monitoring (c) exercises, (d) exercise diary, (e) information, (f) behavioral change and encouragement (g) exercise adherence. In stage 2, 3 themes were determined from interviews: (a) learning and accuracy, (b) ease of use, (c) motivation and adherence. USE and SUS scores indicated that users reported a high level of usability, satisfaction and ease of use. A mobile app for hand exercise for people with RA was developed using a mixed-method and iterative design. Participants perceived the mobile app as easy to use with high levels of satisfaction.
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http://dx.doi.org/10.1007/s00296-021-04860-0DOI Listing
June 2021

Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?

J Clin Epidemiol 2021 Jul 1;135:176-181. Epub 2021 Mar 1.

University of Oxford, Oxford, United Kingdom.

'Blinding' involves concealing knowledge of which trial participants received the interventions from participants themselves and other trial personnel throughout the trial. Blinding reduces bias arising from the beliefs and expectations of these groups. It is agreed that where possible, blinding should be attempted, for example by ensuring that experimental and control treatments look the same. However, there is a debate about if we should measure whether blinding has been successful, this manuscript will discuss this controversy, including the benefits and risks of measuring blinding within the randomised controlled trial.
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http://dx.doi.org/10.1016/j.jclinepi.2021.02.022DOI Listing
July 2021

Rehabilitation to enable recovery from COVID-19: a rapid systematic review.

Physiotherapy 2021 06 24;111:4-22. Epub 2021 Feb 24.

University of Exeter, UK.

Objectives: To establish the evidence for rehabilitation interventions tested in populations of patients admitted to ICU and critical care with severe respiratory illness, and consider whether the evidence is generalizable to patients with COVID-19.

Methods: The authors undertook a rapid systematic review. Medline (via OvidSP), CINAHL Complete (via EBSCOhost), Cochrane Library, Cochrane Database of Systematic Reviews and CENTRAL (via Wiley), Epistemonikos (via Epistemonikos.org), PEDro (via pedro.org.au) and OTseeker (via otseeker.com) searched to 7 May 2020. The authors included systematic reviews, RCTs and qualitative studies involving adults with respiratory illness requiring intensive care who received rehabilitation to enhance or restore resulting physical impairments or function. Data were extracted by one author and checked by a second. TIDier was used to guide intervention descriptions. Study quality was assessed using Critical Skills Appraisal Programme (CASP) tools.

Results: Six thousand nine hundred and three titles and abstracts were screened; 24 systematic reviews, 11 RCTs and eight qualitative studies were included. Progressive exercise programmes, early mobilisation and multicomponent interventions delivered in ICU can improve functional independence. Nutritional supplementation in addition to rehabilitation in post-ICU hospital settings may improve performance of activities of daily living. The evidence for rehabilitation after discharge from hospital following an ICU admission is inconclusive. Those receiving rehabilitation valued it, engendering hope and confidence.

Conclusions: Exercise, early mobilisation and multicomponent programmes may improve recovery following ICU admission for severe respiratory illness that could be generalizable to those with COVID-19. Rehabilitation interventions can bring hope and confidence to individuals but there is a need for an individualised approach and the use of behaviour change strategies. Further research is needed in post-ICU settings and with those who have COVID-19. Registration: Open Science Framework https://osf.io/prc2y.
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http://dx.doi.org/10.1016/j.physio.2021.01.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7902208PMC
June 2021

Cognitive-behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis.

Health Technol Assess 2021 Feb;25(9):1-378

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: 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.

Objectives: 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.

Data Sources: 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.

Review Methods: 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  < 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.

Results: A total of 494 reviews were mapped, representing 68% (27/40) of the categories of the 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,  = 32%), anxiety (standardised mean difference 0.30, 95% confidence interval 0.18 to 0.43, prediction interval -0.28 to 0.88,  = 62%) and pain (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval -0.28 to 0.74,  = 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.

Limitations: Data extraction and analysis were conducted at the review level, rather than returning to the individual trial data. This meant that the risk of bias of the individual trials could not be accounted for, but only the quality of the systematic reviews that synthesised them.

Conclusion: 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 Work: Future research should focus on how the modest effect sizes seen with cognitive-behavioural therapy can be increased, for example identifying alternative delivery formats to increase adherence and reduce dropout, and pursuing novel methods to assess intervention fidelity and quality.

Study Registration: This study is registered as PROSPERO CRD42017078690.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 9. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957459PMC
February 2021

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.

BMJ Open 2021 02 16;11(2):e044462. Epub 2021 Feb 16.

College of Medicine and Health, University of Exeter, Exeter, UK.

Objectives: To review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain.

Design: A review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain.

Methods: We included in our review a selection of 10 trials that were included in a Cochrane review and compared manual therapy and exercise intervention with another intervention. Trials were assessed independently by two reviewers using two checklists: the Template for Intervention Description and Replication (TIDieR) and the Health Behavior Change Consortium treatment fidelity (National Institutes of Health Behaviour Change Consortium/NIHBCC).

Results: TIDieR overall scores for individual trials ranged from 11.1% to 45% and fidelity scores ranged from 7% to 50%. On average, trials scored the following within each domain of NIHBCC: study design 51%; training of providers 8%; treatment delivery 15%; treatment receipt 14% and treatment enactment 2.5%.

Conclusions: Little information about the monitoring, implementation and reporting of interventions was provided by trials and that is a barrier for implementing or replicating these interventions. The lack of information regarding the implementation of interventions needs to be taken into account when assessing whether effectiveness of interventions was impacted by their design or due to deviations from the protocol within trials.
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http://dx.doi.org/10.1136/bmjopen-2020-044462DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7888324PMC
February 2021

Identification of subgroup effect with an individual participant data meta-analysis of randomised controlled trials of three different types of therapist-delivered care in low back pain.

BMC Musculoskelet Disord 2021 Feb 16;22(1):191. Epub 2021 Feb 16.

Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.

Background: 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.

Methods: We conducted an individual 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 individual participant data meta-analysis.

Results: 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.

Conclusions: 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.
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http://dx.doi.org/10.1186/s12891-021-04028-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885433PMC
February 2021

The evidence for cognitive behavioural therapy in any condition, population or context: a meta-review of systematic reviews and panoramic meta-analysis.

Psychol Med 2021 01 18;51(1):21-29. Epub 2021 Jan 18.

College of Medicine and Health, University of Exeter, Exeter, UK.

The majority of psychological treatment research is dedicated to investigating the effectiveness of cognitive behavioural therapy (CBT) across different conditions, population and contexts. We aimed to summarise the current systematic review evidence and evaluate the consistency of CBT's effect across different conditions. We included reviews of CBT randomised controlled trials in any: population, condition, format, context, with any type of comparator and published in English. We searched DARE, Cochrane, MEDLINE, EMBASE, PsycINFO, CINAHL, CDAS, and OpenGrey between 1992 and January 2019. Reviews were quality assessed, their data extracted and summarised. The effects upon health-related quality of life (HRQoL) were pooled, within-condition groups. If the across-condition heterogeneity was I2 < 75%, we pooled effects using a random-effect panoramic meta-analysis. We summarised 494 reviews (221 128 participants), representing 14/20 physical and 13/20 mental conditions (World Health Organisation's International Classification of Diseases). Most reviews were lower-quality (351/494), investigated face-to-face CBT (397/494), and in adults (378/494). Few reviews included trials conducted in Asia, South America or Africa (45/494). CBT produced a modest benefit across-conditions on HRQoL (standardised mean difference 0.23; 95% confidence intervals 0.14-0.33, I2 = 32%). The effect's associated prediction interval -0.05 to 0.50 suggested CBT will remain effective in conditions for which we do not currently have available evidence. While there remain some gaps in the completeness of the evidence base, we need to recognise the consistent evidence for the general benefit which CBT offers.
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http://dx.doi.org/10.1017/S0033291720005292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856415PMC
January 2021

Synergistic effects of hip/knee osteoarthritis and comorbidities on mobility and self-care limitations among older adults: Cross-sectional analysis of the Oxford pain, Activity and Lifestyle study.

J Comorb 2020 Jan-Dec;10:2235042X20974529. Epub 2020 Dec 4.

Centre for Rehabilitation Research in Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, UK.

Objective: To estimate synergistic effects of hip/knee osteoarthritis (OA) and comorbidities on mobility or self-care limitations among older adults.

Methods: 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 individual effects, known as the synergy index.

Results: 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.

Conclusions: 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.
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http://dx.doi.org/10.1177/2235042X20974529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7720340PMC
December 2020

The Prevalence of Back and Leg Pain and the Cross-sectional Association With Adverse Health Outcomes in Community Dwelling Older Adults in England.

Spine (Phila Pa 1976) 2021 Jan;46(1):54-61

Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

Study Design: Cross-sectional analysis of the Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study.

Objective: The aim of this study was to assess the prevalence of back pain (BP) and leg pain and determine their relationship with adverse health states among older adults in England.

Summary Of Background Data: Epidemiological data describing the prevalence of BP and leg pain in older adults in England is lacking.

Methods: A total of 5304 community-dwelling adults (aged 65-100 years) enrolled in the OPAL cohort study who provided data on BP and leg pain were included. Participants were classified into four groups based on reports of back and leg pain: no BP, BP only, BP and leg pain which was likely to be neurogenic claudication (NC), and BP and leg pain which was not NC. Adverse health states were frailty, falls, mobility decline, low walking confidence, poor sleep quality, and urinary incontinence. We collected demographic and socioeconomic information, health-related quality of life, and existing health conditions, and estimated the association between BP presentations and adverse health states using regression analysis.

Results: Thirty-four percent of participants (1786/5304) reported BP only, 11.2% (n = 594/5304) reported BP and NC and 8.3% (n = 441/5304) reported BP and non-NC leg pain. Participants with BP had worse quality of life compared to those without BP. All BP presentations were significantly associated with adverse health states. Those with NC were most affected. In particular, there was greater relative risk (RR) of low walking confidence (RR 3.11, 95% confidence interval [CI] 2.56-3.78), frailty (RR 1.88, 95% CI 1.67-2.11), and mobility decline (RR 1.74, 95% CI 1.54-1.97) compared to no BP.

Conclusion: Back and leg pain is a common problem for older adults and associated with reduced quality of life and adverse health states. Findings suggest a need to develop more effective treatment for older adults with BP especially for those with neurogenic claudication.

Level Of Evidence: 2.
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http://dx.doi.org/10.1097/BRS.0000000000003719DOI Listing
January 2021

Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT.

Health Technol Assess 2020 12;24(71):1-162

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Background: Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective.

Objectives: To compare the clinical effectiveness and cost-effectiveness of three treatments in secondary care for adults with frozen shoulder; to qualitatively explore the acceptability of these treatments to patients and health-care professionals; and to update a systematic review to explore the trial findings in the context of existing evidence for the three treatments.

Design: This was a pragmatic, parallel-group, multicentre, open-label, three-arm, randomised superiority trial with unequal allocation (2 : 2 : 1). An economic evaluation and a nested qualitative study were also carried out.

Setting: The orthopaedic departments of 35 hospitals across the UK were recruited from April 2015, with final follow-up in December 2018.

Participants: Participants were adults (aged ≥ 18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation in the affected shoulder to < 50% of the opposite shoulder, and with plain radiographs excluding other pathology.

Interventions: The inventions were early structured physiotherapy with a steroid injection, manipulation under anaesthesia with a steroid injection and arthroscopic capsular release followed by manipulation. Both of the surgical interventions were followed with post-procedural physiotherapy.

Main Outcome Measures: The primary outcome and end point was the Oxford Shoulder Score at 12 months post randomisation. A difference of 5 points between early structured physiotherapy and manipulation under anaesthesia or arthroscopic capsular release or of 4 points between manipulation under anaesthesia and arthroscopic capsular release was judged clinically important.

Results: The mean age of the 503 participants was 54 years; 319 were female (63%) and 150 had diabetes (30%). The primary analyses comprised 473 participants (94%). At the primary end point of 12 months, participants randomised to arthroscopic capsular release had, on average, a statistically significantly higher (better) Oxford Shoulder Score than those randomised to manipulation under anaesthesia (2.01 points, 95% confidence interval 0.10 to 3.91 points;  = 0.04) or early structured physiotherapy (3.06 points, 95% confidence interval 0.71 to 5.41 points;  = 0.01). Manipulation under anaesthesia did not result in statistically significantly better Oxford Shoulder Score than early structured physiotherapy (1.05 points, 95% confidence interval -1.28 to 3.39 points;  = 0.38). No differences were deemed of clinical importance. Serious adverse events were rare but occurred in participants randomised to surgery (arthroscopic capsular release, = 8; manipulation under anaesthesia, = 2). There was, however, one serious adverse event in a participant who received non-trial physiotherapy. The base-case economic analysis showed that manipulation under anaesthesia was more expensive than early structured physiotherapy, with slightly better utilities. The incremental cost-effectiveness ratio for manipulation under anaesthesia was £6984 per additional quality-adjusted life-year, and this intervention was probably 86% cost-effective at the threshold of £20,000 per quality-adjusted life-year. Arthroscopic capsular release was more costly than early structured physiotherapy and manipulation under anaesthesia, with no statistically significant benefit in utilities. Participants in the qualitative study wanted early medical help and a quicker pathway to resolve their shoulder problem. Nine studies were identified from the updated systematic review, including UK FROST, of which only two could be pooled, and found that arthroscopic capsular release was more effective than physiotherapy in the long-term shoulder functioning of patients, but not to the clinically important magnitude used in UK FROST.

Limitations: Implementing physiotherapy to the trial standard in clinical practice might prove challenging but could avoid theatre use and post-procedural physiotherapy. There are potential confounding effects of waiting times in the trial.

Conclusions: None of the three interventions was clearly superior. Early structured physiotherapy with a steroid injection is an accessible and low-cost option. Manipulation under anaesthesia is the most cost-effective option. Arthroscopic capsular release carries higher risks and higher costs.

Future Work: Evaluation in a randomised controlled trial is recommended to address the increasing popularity of hydrodilatation despite the paucity of high-quality evidence.

Trial Registration: Current Controlled Trials ISRCTN48804508.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 71. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750869PMC
December 2020

Exercise Effects on Falls, Fractures, Hospitalizations, and Mortality in Older Adults With Dementia: An Individual-Level Patient Data Meta-analysis.

J Gerontol A Biol Sci Med Sci 2021 Aug;76(9):e203-e212

Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), France.

Background: To study the effects of exercise on falls, fractures, hospitalizations, and death in people with dementia.

Method: We conducted an individual-level patient data meta-analysis of 7 randomized controlled trials (RCTs). We looked for studies from the reference list of previous systematic reviews and undertook an electronic search for articles published between 2013 and 2019 in Ageline, CENTRAL, PsycINFO, PubMed, and SportsDiscus. Main (binary) outcome measures were the risk of mortality, hospitalization, faller, multiple faller, injurious faller, and fractures. Secondary (count) outcomes were the incident rates of hospitalizations, falls, and injurious falls.

Results: From the 1314 participants, 771 were allocated to the exercise group and 543 to the control group. The number of cases regarding the main outcome measures in exercisers and controls were, respectively: 45 (5.8%) and 31 (5.7%) deaths; 102 (14.4%) and 65 (13.4%) participants hospitalized; 221 (34.4%) and 175 (41.3%) had at least 1 fall; 128 (20.2%) and 92 (21.7%) had multiple falls; 78 (24.8%) and 92 (29.3%) had injurious falls; and 19 (2.9%) and 15 (3.5%) had suffered a fracture. Two-step meta-analysis found no effects of exercise on any outcome. One-step meta-analysis found exercise reduced the risk of falls (odds ratio 0.75; 95% CI: 0.57-0.99). Exploratory analysis showed exercise decreased the rate of incident falls in participants with the lowest functional ability (incident rate ratio 0.48; 95% CI: 0.30-0.79).

Conclusions: Although the 2-step meta-analysis suggests exercise does not have an effect on the outcomes, 1-step meta-analysis suggested that exercise may reduce fall risk. Data from further high-quality RCTs are still needed.
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http://dx.doi.org/10.1093/gerona/glaa307DOI Listing
August 2021

The online version of an evidence-based hand exercise program for people with rheumatoid arthritis: A mixed-method, proof-of-concept study.

J Hand Ther 2020 Oct 26. Epub 2020 Oct 26.

Centre for Rehabilitation Research in Oxford, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

Introduction: The Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, 12-week hand and arm exercise program recommended in the National Institute for Health and Care Excellence guidelines. It includes seven mobility exercises and four strength exercises against resistance. An online version of the SARAH program (mySARAH) has been developed to allow direct access for people with rheumatoid arthritis.

Purpose: The purpose of this study was to assess the feasibility, acceptability, and clinical impact of mySARAH in people with rheumatoid arthritis.

Study Design: This is a mixed-method, proof-of-concept study.

Methods: mySARAH is a self-guided, online version of the SARAH program with six exercise training and review sessions. Participants were observed as they worked through four of the six online sessions. They were also asked to demonstrate the SARAH exercises. Participants undertook two sessions independently at home. At the baseline and 12 weeks, hand pain, hand function, and grip strength were measured. At 12 weeks, feedback on mySARAH, and perceived recovery were also collected. Approximately one month later, a telephone follow-up was conducted to explore participants' experiences with mySARAH. Pain, hand function, and perceived recovery were also assessed.

Results: Eleven participants (males/females: 3/8) with a median (interquartile range) age of 63 (17) years took part. Six participants completed all mySARAH sessions. About 512 exercise and load-setting demonstrations were observed and 491 (96%) were performed correctly. Improvements in grip strength and hand function were observed with no increase in pain. Most of the participants reported improvement and provided positive feedback. All participants perceived mySARAH as a useful resource. Features to improve the online exercise diary such as recording and tracking exercise dose and face-to-face or remote support by phone or Skype from health professionals were suggested to optimize user engagement.

Conclusions: Initial evaluation of mySARAH indicates that mySARAH was feasible, acceptable, and beneficial to participants. Further iteration and evaluation are needed before large-scale implementation.
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http://dx.doi.org/10.1016/j.jht.2020.10.011DOI Listing
October 2020

The findings of a surgical hip fracture trial were generalizable to the UK national hip fracture database.

J Clin Epidemiol 2021 03 3;131:141-151. Epub 2020 Dec 3.

Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Newark Street, London, UK; Barts Health NHS Trust, London, UK.

Objective: To estimate the generalizability of treatment effects observed in a randomized trial of hip fracture surgery implants to a broader population of people undergoing hip surgery in the United Kingdom.

Study Design And Setting: In 2018, the WHiTE-3 trial (n = 958) demonstrated that a modular hemiarthroplasty implant conferred no additional benefit over the traditional monoblock implant for quality of life and length of hospital stay. We compared and weighted the trial sample against two target populations: WHiTE-cohort (n = 2,457) and UK-National Hip Fracture Database (NHFD, n = 190,894), and re-estimate expected treatment effects for the target populations.

Results: Despite differences in baseline characteristics of the trial sample and target populations, the re-estimated treatment effects were comparable. For quality of life, the differences between the trial estimate and WHiTE-cohort and NHFD estimates were 0.01 points on the EuroQol (EQ5D). For length of stay, the difference between the trial estimate and WHiTE-cohort was 0.50 days; and the difference between the trial estimate and NHFD estimate was -0.47 days.

Conclusion: This generalizability analysis of the WHiTE-3 trial found that the inferences from the trial can be generalized to a wider population of individuals in the UK NHFD and the WHiTE-cohort who met the inclusion criteria for WHiTE-3.
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http://dx.doi.org/10.1016/j.jclinepi.2020.11.016DOI Listing
March 2021

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.

Health Technol Assess 2020 11;24(65):1-116

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: 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.

Objectives: 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.

Design: An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study.

Setting: The trial took place in 14 NHS physiotherapy departments.

Participants: People identified as being at high risk of a poor outcome after knee arthroplasty.

Interventions: A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy.

Main Outcome Measures: 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.

Results: 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;  = 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.

Limitations: The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded.

Conclusions: 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.

Trial Registration: Current Controlled Trials ISRCTN13517704.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750865PMC
November 2020

Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.

Platelets 2021 Feb 26;32(2):273-279. Epub 2020 Nov 26.

Kadoorie Centre for Critical Care Research, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Platelet-rich plasma (PRP) is an autologous preparation that has been claimed to improve healing and mechanobiological properties of tendons both in vitro and in vivo. In this sub-study from the PATH-2 (PRP in Achilles Tendon Healing-2) trial, we report the cellular and growth factor content and quality of the Leukocyte-rich PRP (L-PRP) (N = 103) prepared using a standardized commercial preparation method across 19 different UK centers. Baseline whole blood cell counts (red cells, leukocyte and platelets) demonstrated that the two groups were well-matched. L-PRP analysis gave a mean platelet count of 852.6 x 10/L (SD 438.96), a mean leukocyte cell count of 15.13 x 10/L (SD 10.28) and a mean red blood cell count of 0.91 x 10/L (SD 1.49). The activation status of the L-PRP gave either low or high expression levels of the degranulation marker CD62p before and after ex-vivo platelet activation respectively. TGF-β, VEGF, PDGF, IGF and FGFb mean concentrations were 131.92 ng/ml, 0.98 ng/ml, 55.34 ng/ml, 78.2 ng/ml and 111.0 pg/ml respectively with expected correlations with both platelet and leukocyte counts. While PATH-2 results demonstrated that there was no evidence L-PRP is effective for improving clinical outcomes at 24 weeks after Achilles tendon rupture, our findings support that the majority of L-PRP properties were within the method specification and performance.
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http://dx.doi.org/10.1080/09537104.2020.1849604DOI Listing
February 2021

Screening and Intervention to Prevent Falls and Fractures in Older People.

N Engl J Med 2020 11;383(19):1848-1859

From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).

Background: Community screening and therapeutic prevention strategies may reduce the incidence of falls in older people. The effects of these measures on the incidence of fractures, the use of health resources, and health-related quality of life are unknown.

Methods: In a pragmatic, three-group, cluster-randomized, controlled trial, we estimated the effect of advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise for people at increased risk for falls) as compared with advice by mail only. The primary outcome was the rate of fractures per 100 person-years over 18 months. Secondary outcomes were falls, health-related quality of life, frailty, and a parallel economic evaluation.

Results: We randomly selected 9803 persons 70 years of age or older from 63 general practices across England: 3223 were assigned to advice by mail alone, 3279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail. A falls-risk screening questionnaire was sent to persons assigned to the exercise and multifactorial fall-prevention groups. Completed screening questionnaires were returned by 2925 of the 3279 participants (89%) in the exercise group and by 2854 of the 3301 participants (87%) in the multifactorial fall-prevention group. Of the 5779 participants from both these groups who returned questionnaires, 2153 (37%) were considered to be at increased risk for falls and were invited to receive the intervention. Fracture data were available for 9802 of the 9803 participants. Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71). The exercise strategy was associated with small gains in health-related quality of life and the lowest overall costs. There were three adverse events (one episode of angina, one fall during a multifactorial fall-prevention assessment, and one hip fracture) during the trial period.

Conclusions: Advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls did not result in fewer fractures than advice by mail alone. (Funded by the National Institute of Health Research; ISRCTN number, ISRCTN71002650.).
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http://dx.doi.org/10.1056/NEJMoa2001500DOI Listing
November 2020

Musculoskeletal pain and loneliness, social support and social engagement among older adults: Analysis of the Oxford Pain, Activity and Lifestyle cohort.

Musculoskeletal Care 2021 Sep 17;19(3):269-277. Epub 2020 Nov 17.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford, UK.

Background: 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.

Methods: 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.

Results: Of the 4977 participants analysed, 4193 (84.2%) reported any MSK pain, and one-quarter (n = 1298) reported widespread pain. Individuals 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.

Conclusions: 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.
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http://dx.doi.org/10.1002/msc.1526DOI Listing
September 2021

Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.

Lancet 2020 10;396(10256):977-989

Physiotherapy Research Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

Background: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection.

Methods: In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508.

Findings: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release).

Interpretation: All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective.

Funding: The National Institute for Health Research Health Technology Assessment programme.
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http://dx.doi.org/10.1016/S0140-6736(20)31965-6DOI Listing
October 2020
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