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Abstract Background During the COVID-19 pandemic, social distancing and reduced social contact may have affected older adults’ health. Objectives To evaluate the perceived impact of social distancing on older adults’ health and explore the association between social contact and health outcomes. Design Cross-sectional and longitudinal analyses of the OPAL cohort study. Subjects Community dwelling older adults. Methods We sent questionnaires to participants of an existing cohort study (n = 4328). Questions included the amount and type of social contact, and how often they went outside. Participants rated the impact of social distancing on their health. Sociodemographic factors and quality of life were available from previous questionnaires. We examined quality of life prior to and during the pandemic and explored the cross-sectional relationship between social contact and health using logistic regression. Results There were 3856/4328 (89%) questionnaires returned. EQ-5D scores changed little compared to pre-pandemic scores but 25% of participants reported their overall health had worsened. The telephone was the most used method of contact (78%). Video calls were used least with 35% of participants not using them or having no access to them. 13% of respondents never went outside. Lower levels of contact were associated with increased risk of reporting worse health (Odds ratio (OR) 1.04 (95% CI 1.01–1.08)). Those experiencing financial strain and who spent less time outside experienced the largest increase in risk of reporting perceived worsened overall health. Those reporting a strain to get by financially were 4 times more likely to report worsened health than those who described themselves as quite comfortably off (OR 4.00 (95% CI 1.86–8.16)). Participants who reported never going outside were twice as likely to report worsened health compared to those who went outside daily (OR 2.00 (95% CI 1.57–2.54)). Conclusions Less contact with other people was associated with perceived worsening in overall health. Although many older people reported using online technology, such as video calls, a substantial proportion were not using them. Older people facing financial strain were more likely to report worsened health, highlighting the impact of social inequalities during the pandemic. Going outside less was also associated with perceived worsened health.

Background Back pain frequently affects older people. Knowledge about back pain in older people and evidence to inform clinical care was lacking, particularly for older people with neurogenic claudication due to spinal stenosis, which is a debilitating condition. Objectives To understand and reduce the burden of back pain on older people by increasing knowledge about back pain in older people and developing evidence-based treatment strategies. Design We completed six work packages. These were not undertaken chronologically as there was overlap between work packages. Work package 1: Refine a physiotherapy intervention for neurogenic claudication. Work package 2: Feasibility of the Oxford Pain Activity and Lifestyle cohort study and Better Outcomes for Older people with Spinal Trouble randomised controlled trial. Work package 3: Development of a prognostic tool to identify when older people are at risk of mobility decline using data from the Oxford Pain Activity and Lifestyle cohort study. Work package 4: A randomised controlled trial of physiotherapy for neurogenic claudication and nested longitudinal qualitative study (Better Outcomes for Older people with Spinal Trouble randomised controlled trial). Work package 5: Predictors of participants’ response to treatment – prespecified subgroup analyses. Work package 6: Implementation planning. Setting Primary care and National Health Service Community and Secondary Care Trusts. Participants Community-dwelling adults over the age of 65 years and registered with primary care practices. Better Outcomes for Older people with Spinal Trouble trial participants reported back and/or leg pain consistent with neurogenic claudication. Interventions The Better Outcomes for Older people with Spinal Trouble programme was a physiotherapy-delivered combined physical and psychological group intervention for older people with neurogenic claudication. The comparator was a physiotherapy assessment and tailored advice (best practice advice). Main outcome measures The primary outcome for the Oxford Pain Activity and Lifestyle prognostic tool was mobility decline based on the EQ-5D-5L Mobility Question. The primary outcome for the Better Outcomes for Older people with Spinal Trouble trial was the Oswestry Disability Index at 12 months. Other outcomes included the Oswestry Disability Index walking item, 6-minute walk test and falls. The economic analyses used the EuroQol EQ-5D-5L to measure quality of life. Results Among Oxford Pain Activity and Lifestyle participants, 34% (1786/5304) reported back pain. A further 19.5% (1035/5304) reported back pain and associated leg pain, with 11.2% (n = 594/5304) reporting symptoms consistent with neurogenic claudication. Participants with back pain had worse quality of life compared to those without back pain and reported more adverse health states such as falls, frailty, low walking confidence and mobility decline. Those with neurogenic claudication were worst affected. At 2 years’ follow-up, among those reporting back pain at baseline, only 23% (489/2100) no longer reported symptoms. Recovery was lowest among participants reporting neurogenic claudication at baseline, with 90% still reporting symptoms. At 2 years’ follow-up, 18.6% of Oxford Pain Activity and Lifestyle participants reported mobility decline. Back pain with/without leg pain was not an independent predictor of mobility decline, but lower limb pain and the report of severe pain were independent predictors. Other predictors included slow walking pace, balance difficulties, low walking confidence, walking ability worse than last year, self-reported general health and comorbidity. In the Better Outcomes for Older people with Spinal Trouble trial, there was no significant difference in Oswestry Disability Index scores between treatment groups at 12 months (adjusted mean difference −1.4, 95% confidence interval −4.03 to 1.17), but at 6 months, scores favoured the Better Outcomes for Older people with Spinal Trouble programme (adjusted mean difference −3.7, 95% confidence interval −6.27 to −1.06). The Better Outcomes for Older people with Spinal Trouble programme resulted in greater improvements in the 6-minute walk test (mean difference 21.7 m, 95% confidence interval 5.96 to 37.38 m) and walking item (mean difference −0.2, 95% confidence interval −0.45 to −0.01) and reduced falls risk (odds ratio 0.6, 95% confidence interval 0.40 to 0.98) compared to best practice advice at 12 months. The probability that the Better Outcomes for Older people with Spinal Trouble programme is cost-effective ranged between 67% and 83% (National Health Service and Personal Social Services perspective) and between 79% and 89% (societal perspective) across cost-effectiveness thresholds between £15,000 and £30,000 per quality-adjusted life-year. From the embedded qualitative study, the Better Outcomes for Older people with Spinal Trouble programme was acceptable to participants, and enjoyable. Limitations Many of the data collected were self-reported and thus may be subject to recall bias or may have resulted in misclassification of participants. Conclusions Back pain is a substantial problem for older people, with the majority reporting persistent symptoms. We have developed an effective intervention to improve mobility and reduce falls in older people with neurogenic claudication; however, more effective interventions are needed for back pain generally. We have identified a set of self-reported questions that predict mobility decline in older people, so clinicians and their patients and families know when intervention is needed. Future work Develop and evaluate treatments for older people with back pain. Optimisation of the Better Outcomes for Older people with Spinal Trouble programme to better target pain-related disability. External validation of the Oxford Pain Activity and Lifestyle prognostic tool. Study registration This trial is registered as BOOST trial ISRCTN12698674. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: PTC-RP-PG-0213-20002) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 9. See the NIHR Funding and Awards website for further award information. Plain language summary Back pain is a common problem for older people. This research aimed to increase our understanding of back pain in older people and to develop treatments to reduce the burden caused by back pain. The research was arranged in six work packages, and we completed three linked studies. Study 1: We enrolled 5409 older people in a cohort study. Participants answered questions about back pain, their health, mobility, falls and quality of life on enrolment and at 1 and 2 years’ follow-up. Back pain was reported by half of the participants, and 20% also reported leg pain. Back pain with/without leg pain is associated with reduced quality of life but also with being frail, falling and having walking problems. After 2 years, 77% of participants still reported being troubled by this pain. We developed a tool to identify when older people were at risk of reduced walking ability and to understand whether back pain was important here. Back and leg pain were not specifically linked to reduced walking, but severe pain was, suggesting that regardless of the type of pain, it needs to be treated. This tool could be used by clinicians and patients to know when they are at risk of reduced walking ability and to seek treatment. Study 2: We developed a group physiotherapy programme (the Better Outcomes for Older people with Spinal Trouble programme) for older people with a back-related condition called neurogenic claudication which results in pain spreading from the back into the legs and difficulties standing and walking. We tested the programme in a randomised controlled trial. The Better Outcomes for Older people with Spinal Trouble programme resulted in long-term improvements in walking, reduced falls, and short-term improvements in pain and disability. It is likely to be good value for the National Health Service. Study 3: We interviewed participants taking part in the Better Outcomes for Older people with Spinal Trouble trial to understand their experiences of the trial and whether the treatments helped. The Better Outcomes for Older people with Spinal Trouble programme was acceptable to participants, and they found it enjoyable. We are working with patient representatives and clinicians to make the Better Outcomes for Older people with Spinal Trouble programme available in routine care. Scientific summary Background Back pain (BP) is a common problem for older people but despite this, many older people either do not consult or general practitioners do not prioritise BP treatment for them due to the perception that nothing can be done. Many clinical trials exclude older people, and little attention has been paid to understanding the presentation of BP in older people and developing effective treatments. Older adults also experience leg pain referred from the lumbar spine. A common clinical presentation of spinal-related leg pain in older adults is neurogenic claudication (NC). It presents as symptoms radiating from the spine into the buttocks and legs which are provoked by walking or standing and relieved by sitting or lumbar flexion, often accompanied by BP. NC is particularly problematic for older people as it can cause severe pain and discomfort and substantially affect an individual’s confidence and ability to walk. Symptoms are thought to arise from pressure on nerves and blood vessels caused by degenerative changes narrowing the volume of the lumbar spinal canal. Narrowing may or may not be evident on imaging but when present, the condition is termed lumbar spinal stenosis. Physiotherapy is recommended prior to surgical intervention, but high-quality evidence to guide conservative care, including primary care management or physiotherapy, was lacking. Thus, we focused on NC to develop and test a physiotherapy intervention. We aimed to conduct a series of linked studies to increase knowledge and understanding about BP in older people and reduce the burden on older people by developing evidence-based treatment strategies. Objectives To describe the presentation and impact of BP in community-dwelling older adults. To refine a physiotherapy intervention for older people with NC and to evaluate the clinical and cost-effectiveness of this intervention in a randomised controlled trial (RCT). To understand the trial participants’ experiences, including acceptability and impact of the interventions. To understand the role of low BP in mobility decline through the development of a prognostic tool to predict when older people are at risk of mobility decline. To integrate findings into an implementation package. Methods We undertook three studies. A large population-based cohort study of community-dwelling older people recruited from primary care practices [the Oxford Pain Activity and Lifestyle (OPAL) cohort study]. We recruited older adults from primary care practices who were identified through electronic record searches and randomly selected eligible participants from two stratified age bands (65–74 and ≥ 75 years). In total, 5409 individuals (42.1% of eligible participants) from 35 general practices agreed to participate and followed up for 2 years by postal questionnaire. Participants provided data including demographics, socioeconomic factors, comorbidities, pain including low BP and its impact, other pain problems, physical activity, mobility, falls, frailty and quality of life. At baseline, we investigated the prevalence of BP and related leg pain within the cohort and estimated the association between different back and leg pain presentations and age-related adverse health states, including falls, frailty and mobility decline, using regression analyses. At 2 years, we estimated recovery rates. We investigated the role of back and leg pain in mobility decline by developing a prediction model for mobility decline at 2 years’ follow-up. Thirty-one candidate self-reported baseline predictors were prespecified. Missing data were imputed. Least Absolute Shrinkage and Selection Operator regression was used to select potential predictors. Model performance was assessed by calculating c-statistic, Brier score and decision-curve analysis. Models were internally validated using bootstrapping. The Better Outcomes for Older people with Spinal Trouble (BOOST) RCT of physiotherapy interventions for NC. We evaluated the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and tailored advice [best practice advice (BPA)] for older people with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records, and were randomised 2:1 to the BOOST programme or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT) and falls. The primary analysis was intention-to-treat. Prespecified subgroup analyses were also undertaken based on magnetic resonance imaging (MRI) parameters and other baseline factors including age, sex, frailty and physical capacity. The base-case economic evaluation was an intention-to-treat analysis conducted from a UK NHS and personal social services (PSS) perspective and separately from a societal perspective. Costs (2018–19 prices) were collected prospectively over 12 months. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit (INMB) of the BOOST programme in comparison to BPA. A longitudinal qualitative study embedded within the BOOST RCT. Embedded within the BOOST RCT was a longitudinal qualitative study. Semistructured interviews with participants were undertaken at baseline, 1 month after receiving their intervention and at 12 months. We analysed 30 sets of three interviews. We undertook an inductive thematic analysis and comparatively analysed data from the three time points to explore patients’ experiences with the trial interventions, including the impact on symptoms and their experiences of long-term exercise adherence. Results Oxford Pain Activity and Lifestyle cohort study Among OPAL participants, 34% (1786/5304) reported BP. A further 19.5% (1035/5304) reported BP and associated leg pain, with 11.2% (n = 594/5304) reporting symptoms consistent with NC. 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 to 3.78], frailty (RR 1.88, 95% CI 1.67 to 2.11) and mobility decline (RR 1.74, 95% CI 1.54 to 1.97) compared to no BP. Of the participants reporting BP at baseline, 2139/2859 (74.8%) returned the 2-year follow-up questionnaire, and 23% of respondents no longer reported back or leg symptoms (489/2100). Recovery was highest among those reporting only BP at baseline (27.4%) and lowest among those reporting NC at baseline (10.9%). Participants reporting NC at baseline were most affected by symptoms at follow-up, reporting BP more frequently, with the highest proportion reporting very or extremely troublesome BP. They reported the highest pain interference ratings at follow-up, with the greatest proportion reporting severe interference with activity (26%). At baseline, the majority of OPAL participants reported no mobility problems (60.7%; 3146/5184) and 5.4% (280/5184) reported severe mobility problems. Two-year follow-up data were provided by 4115/5184 (79.4%) participants, with 18.6% (n = 765/4115) reporting mobility decline. We examined the univariable relationship between the baseline variables and the 2-year outcome. Nearly all the selected baseline factors had a univariate relationship with the outcome. Among those with mobility decline at 2 years, there were more reports of back and leg pain and greater numbers reporting multisite pain and widespread pain at baseline. The biggest difference in pain presentation was lower limb pain at baseline, which was reported by 68% of participants with mobility decline at follow-up, compared to 56% without. Baseline pain severity was also associated with mobility decline at follow-up. The multivariable analyses found that in addition to mobility status (no problems or mild problems) at baseline, 13 variables were identified as predictors of mobility decline at 2 years in ≥ 80% of the multiple imputed data sets. BP with/without leg pain was not an independent predictor of mobility decline, but lower limb pain and the report of severe pain were independent predictors. Demographic and socioeconomic factors (older age and those who perceived their income as inadequate) were also identified. There were multiple factors related to mobility, including participants who reported a slow usual walking pace, had difficulty maintaining their balance, had low confidence to walk long distances, rated their walking as worse compared to last year and reported sometimes using a walking aid outside, which were associated with a decline in mobility after 2 years. General health-related factors associated with decline in mobility at 2 years were having a higher body mass index, greater number of health conditions, problems in daily life due to physical tiredness, and poor self-reported general health. The multivariable model revealed a median c-statistic of 0.740 (range 0.737–0.743), indicating moderately good discrimination. The median Brier score was 0.136 (range 0.135–0.137). We developed a point scoring system to facilitate use in clinical practice. Better Outcomes for Older people with Spinal Trouble randomised controlled trial We analysed data from 435 trial participants with an average age of 74.9 years [standard deviation (SD) 6.0 years], and 57% (246/435) were female. At baseline, participants reported moderate disability levels [mean ODI 33 (SD 13.9)]. Their walking was markedly reduced [mean 6MWT 255 m (SD 99.1 m)] compared to healthy older adults. The primary outcome was obtained for 88.0% (383/435) and 87.4% (380/435) of participants at 6 months and 12 months, respectively, with 93.0% (403/435) contributing data to the primary analysis. There was no significant difference in ODI scores between treatment groups at 12 months [adjusted mean difference (MD) −1.4, 95% CI −4.03 to 1.17)], but at 6 months, ODI scores favoured the BOOST programme (adjusted MD –3.7, 95% CI –6.27 to –1.06). At 12 months, the BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7 m, 95% CI 5.96 to 37.38 m) and ODI walking item (MD –0.2, 95% CI –0.45 to –0.01) and reduced falls risk (odds ratio 0.6, 95% CI 0.40 to 0.98) compared to BPA. No serious adverse events were related to either treatment. The economic analyses showed that the mean NHS and PSS costs over 12 months were £19,752 [standard error (SE) £118] in the BOOST arm versus £1827 (SE £169) in the BPA arm (p = 0.474). Mean (SE) QALY estimates were 0.620 (0.009) versus 0.599 (0.006), respectively (p = 0.093). The probability that the BOOST programme is cost-effective ranged between 67% and 83% (NHS and PSS perspective) and between 79% and 89% (societal perspective) across cost-effectiveness thresholds. INMBs ranged between £145 and £464 at cost-effectiveness thresholds between £15,000 and £30,000 per QALY. The Better Outcomes for Older people with Spinal Trouble qualitative study Interviews from 16 men and 14 women were included in this analysis. Fourteen participants were allocated to BPA and 16 were allocated to the BOOST programme. The symptoms of NC manifested both physically and psychologically, limiting participants’ ability to perform everyday activities as well their wider participation in social, leisure and recreational activities. Participants adopted coping strategies to minimise the impact of NC. Participants in the BOOST programme appeared more satisfied with their treatment compared to those allocated to BPA. Dissatisfaction among BPA participants seemed to arise from lack of feedback and follow-up. BOOST participants benefited from peer support and discussions. Most participants felt the exercises were appropriate and helpful, although this did not necessarily translate to improvements in pain. Dissatisfaction with the BOOST programme was mostly related to lack of pain relief. Pain remained a substantial problem for some participants. BOOST programme participants also talked about other improvements from the exercises, including improved posture, strength and confidence, highlighting the broader benefits of the BOOST programme. These types of changes were less evident in the narratives of BPA participants. BOOST participants reported benefit from the cognitive–behavioural component, including helping them to find their own solutions, manage flare-ups and understand the importance of long-term exercise. Reasons for stopping the home exercises were similar between treatment arms. These included competing priorities, lack of motivation and aggravation of pain. Adaptations allowed some BOOST participants to continue at least some of the exercises even when they were difficult. Participant narratives provided insight into ways to optimise the BOOST programme to improve long-term exercise adherence, including additional support to provide motivation for ongoing exercises (by the physiotherapist or by linking to exercise opportunities in the community), provide greater guidance on how to adapt exercises if they are painful, and to help plan integration into everyday life or transition to activities they enjoy. We have developed a package of implementation for the BOOST programme. Feedback from interview participants, patient and public involvement representatives and clinicians who delivered the BOOST programme and ongoing analyses of BOOST data will inform further refinement of the programme to better target pain-related disability. Conclusions Back pain is a substantial and persistent problem for older people, associated with reduced quality of life and age-related adverse health states. The impact is greatest on those with NC, but other presentations should not be ignored due to the high proportion of participants who reported ongoing symptoms. We developed a programme that successfully improved mobility and reduced falls among older people with NC, and future iterations of the programme will aim to reduce long-term pain-related disability. As it stands, the BOOST programme has a high probability of being cost-effective. There is a need to develop other interventions for the large number of older adults affected by BP, especially for those with more severe symptoms. Back and leg pain were not independent predictors of mobility decline, but severe pain was a predictor. This highlights a broader need to manage pain better in older people regardless of the type or presentation of pain. The developed prognostic tool has the potential to help clinicians, older people and their families to identify when an older person is at risk of declining mobility and to take preventative actions. We developed a scoring system so that it could be easily implemented in clinical practice, and future research will focus on external validation of this tool. Study registration This trial is registered as BOOST trial ISRCTN12698674. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: PTC-RP-PG-0213-20002) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 9. See the NIHR Funding and Awards website for further award information.

BackgroundWe previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs.Methods and findingsWe included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations.ConclusionsWe have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.

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 (n = 174) (six or fewer physiotherapy sessions), (2) best-practice advice (n = 174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise (n = 182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice (n = 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 (p = 0.184) and increased the cost by £10 per participant (p = 0.747). Progressive exercise alone was £52 (p = 0.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs (p = 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 Health Technology Assessment; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.

Background: Achilles tendon rupture affects > 11,000 people each year in the UK, leading to prolonged periods away from work, sports and social activities. Traditionally, the ruptured tendon is held still in a plaster cast for ≥ 8 weeks. Functional bracing is an alternative treatment that allows patients to mobilise earlier, but there is little evidence about how bracing affects patients’ recovery. Objectives: To measure the Achilles Tendon Rupture Score, quality of life, complications and resource use of patients receiving non-operative treatment for an Achilles tendon rupture treated with plaster cast compared with those treated with functional bracing. Design: This was a multicentre, randomised, pragmatic, two-group superiority trial. Setting: The setting was 39 NHS hospitals. Participants: A total of 540 adult patients treated non-operatively for Achilles tendon rupture were randomised from July 2016 to May 2018. Exclusion criteria included presenting after 14 days, having had previous rupture and being unable to complete questionnaires. Interventions: A total of 266 participants had a plaster cast applied, with their toes initially pointing to the floor. The cast was changed over 8 weeks to bring the foot into a walking position. A total of 274 patients had a functional brace that facilitated immediate weight-bearing. The foot position was adjusted within the brace over the same 8-week period. Main outcome measures: Achilles Tendon Rupture Score is patient reported and assesses symptoms and physical activity related to the Achilles tendon (score 0–100, with 100 being the best possible outcome). The secondary outcomes were quality of life, complications and resource use at 8 weeks and at 3, 6 and 9 months. Results: Participants had a mean age of 48.7 years, were predominantly male (79%) and had ruptured their tendon during sports (70%). Over 93% of participants completed follow-up. There was no statistically significant difference in Achilles Tendon Rupture Score at 9 months post injury (–1.38, 95% confidence interval –4.9 to 2.1). There was a statistically significant difference in Achilles Tendon Rupture Score at 8 weeks post injury in favour of the functional brace group (5.53, 95% confidence interval 2.0 to 9.1), but not at 3 or 6 months post injury. Quality of life showed the same pattern, with a statistically significant difference at 8 weeks post injury but not at later time points. Complication profiles were similar in both groups. Re-rupture of the tendon occurred 17 times in the plaster cast group and 13 times in the functional brace group. There was no difference in resource use. Conclusions: This trial provides strong evidence that early weight-bearing in a functional brace provides similar outcomes to traditional plaster casting and is safe for patients receiving non-operative treatment of Achilles tendon rupture. The probability that functional bracing is cost-effective exceeds 95% for the base-case imputed analysis, assuming a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. On average, functional brace is associated with lower costs (–£103, 95% confidence interval –£290 to £84) and more quality-adjusted life-years (0.015, 95% confidence interval –0.0013 to 0.030) than plaster cast. Limitations: Some patients declined to participate in the trial, but only a small proportion of these declined because they had a preference for one treatment or another. Overall, 58% of eligible patients agreed to participate, so the participants are broadly representative of the population under investigation. Future work: Although the UK Study of Tendo Achilles Rehabilitation provides guidance with regard to early management, rehabilitation following Achilles tendon rupture is prolonged and further research is required to define the optimal mode of rehabilitation after the initial cast/brace has been removed. Trial registration: Current Controlled Trials ISRCTN62639639. Funding: 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. 8. See the NIHR Journals Library website for further project information.

Abstract Background The TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures in terms of detection of clinically significant prostate cancer (PCa). This article describes the statistical analysis plan (SAP) for the TRANSLATE randomised controlled trial (RCT). Methods/design TRANSLATE is a parallel, superiority, multicentre RCT. Biopsy-naïve men aged ≥ 18 years requiring a prostate biopsy for suspicion of possible PCa are randomised (computer-generated 1:1 allocation ratio) to one of two biopsy procedures: transrectal (TRUS) or local anaesthetic transperineal (LATP) biopsy. The primary outcome is the difference in detection rates of clinically significant PCa (defined as Gleason Grade Group ≥ 2, i.e. any Gleason pattern ≥ 4 disease) between the two biopsy procedures. Secondary outcome measures are th eProBE questionnaire (Perception Part and General Symptoms) and International Index of Erectile Function (IIEF, Domain A) scores, International Prostate Symptom Score (IPSS) values, EQ-5D-5L scores, resource use, infection rates, complications, and serious adverse events. We describe in detail the sample size calculation, statistical models used for the analysis, handling of missing data, and planned sensitivity and subgroup analyses. This SAP was pre-specified, written and submitted without prior knowledge of the trial results. Discussion Publication of the TRANSLATE trial SAP aims to increase the transparency of the data analysis and reduce the risk of outcome reporting bias. Any deviations from the current SAP will be described and justified in the final study report and results publication. Trial registration International Standard Randomised Controlled Trial Number ISRCTN98159689, registered on 28 January 2021 and registered on the ClinicalTrials.gov (NCT05179694) trials registry.

Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).

Abstract Background Distal radius fractures represent about 1 in 5 of all fractures treated in UK hospitals. Most distal radius fractures occur in women aged 50 years or over after a fall. Distal radius fractures are managed using splints or casting, some are also treated with surgical fixation. Patients often experience long-term muscle weakness of the hand and arm that may impact their ability to do daily activities such as personal hygiene, routine household chores and food preparation. We propose a structured and tailored flexibility and resistance exercise programme for the hand and arm supplemented with behaviour change strategies to help perform daily exercise. The main aim of our study is to assess the feasibility of conducting a definitive randomised controlled trial. Methods This study is a multicentre, parallel-group individually randomised feasibility trial. We will recruit a minimum of 72 adults aged 50 years or over with distal radius fracture treated surgically or non-surgically from at least three UK National Health Service (NHS) hospitals. They will be randomised 1:1:1 to receive usual care, usual care and independent exercise with a single therapy session or usual care and supervised exercise with three therapy sessions over 12 weeks. Our primary feasibility objectives are (1) patient engagement assessed by recruitment, (2) acceptability of the interventions assessed by adherence and patient and clinician experience and (3) retention of participants in the trial. Outcome measures will be assessed at baseline, 3 months and at 6 months after randomisation. A qualitative sub-study will explore the experiences of the trial participants and therapists delivering the exercises. Discussion A definitive trial will be considered feasible without major modifications if our progression criteria are met. If successful, the findings will inform the design of a future definitive RCT to evaluate the clinical and cost-effectiveness of the WISE exercise programme. Trial registration ISRCTN12290145 .

Abstract Background Use of a person’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires. Methods Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost. Results Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message. Conclusion Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message. Trial registration GRASP Trial ISRCTN16539266 ; SWAT Repository ID 35

Abstract Background The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised trial. Methods/design UK STAR is a 1:1, multi-centre, parallel, two-arm, superiority randomised controlled trial. This study aims to evaluate the use of functional bracing compared to plaster cast for the management of acute Achilles tendon rupture in adult patients treated non-operatively. The primary outcome is the Achilles Tendon Rupture Score measured at 9 months after injury and will be estimated based on a linear mixed effects regression model adjusted for the stratification factor (centre) and other key prognostic variables. Secondary outcomes include complications, quality of life and resource use evaluated at 8 weeks and at 3, 6 and 9 months after the injury. Missing data will be summarised and reported by treatment arm. Full details of the planned analysis methods are described in this paper. Further study design details are published in the UK STAR protocol. Discussion The planned statistical analyses for UK STAR aim to reduce the risk of outcome reporting bias arising from prior data knowledge. Any changes or deviations from the current SAP will be described and justified in the final study report. Trial registration International Standard Randomised Controlled Trial Number Registry, ISRCTN62639639. Registered on 22 June 2016.