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STAMINA is a randomised controlled trial of a complex lifestyle intervention incorporating exercise prescription into a prostate cancer care pathway. The 12-month intervention aims to improve disease specific quality of life and reduce fatigue of people receiving androgen deprivation therapy for prostate cancer. Previously published work outlines the development of the trial intervention which included recruitment and training of healthcare professionals and exercise professionals to embed a lifestyle intervention and referral pathway within NHS prostate cancer care. A mixed-methods process evaluation, embedded within the STAMINA trial, will be conducted to assess quantitative process outcomes (recruitment, intervention reach, dose and fidelity), together with up to 45 qualitative interviews with patients, healthcare professionals and exercise professionals. Interviews will explore the perceptions and experiences of those involved in the STAMINA trial, and the organisational implications of embedding and sustaining the intervention. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before trial outcomes are known using an inductive and deductive approach. Findings from the different elements will be reported separately and then integrated to inform interpretation of trial outcomes. This process evaluation protocol provides a detailed description of relevant data collection methods and trial processes of the STAMINA randomised controlled trial which will allow us to determine whether the intervention can be delivered with fidelity, is acceptable to patients, healthcare professionals and exercise professionals, and understand the implications for embedding and sustaining the intervention in the routine care. ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

A key goal for working age stroke survivors is to return to work, yet only around 50% achieve this at 12 months. Currently, there is limited evidence of effectiveness of early stroke-specialist vocational rehabilitation (ESSVR) interventions from randomised controlled trials. This study examined fidelity to ESSVR and explored social and structural factors which may have influenced implementation in the RETurn to work After stroKE (RETAKE) randomised controlled trial. Mixed-methods process evaluation assessing intervention fidelity and incorporating longitudinal case-studies exploring stroke survivors' experiences of support to return to work. Normalisation Process Theory, and the Conceptual Model for Implementation Fidelity, informed data collection and analysis. Sixteen sites across England and Wales participated in RETAKE. Forty-eight occupational therapists (OTs), supported by 6 mentors experienced in vocational rehabilitation (VR), delivered the intervention (duration 12 months) between February 2018 and April 2022. Twenty-six participants (15 ESSVR, 11 usual care (UC)) were included in longitudinal case-studies. An additional 18 participants (8 ESSVR and 10 UC) were interviewed once. Nineteen OTs, 6 mentors and 19 service managers were interviewed. Fidelity was measured for 39 ESSVR participants; mean fidelity score was 78.8% (SD:19.2%, range 31-100%). Comparison of the experiences of ESSVR and UC participants indicated duration and type of support to return to work were perceived to be better for ESSVR participants. They received early, co-ordinated support including employer liaison and workplace adjustments where appropriate. In contrast, UC participants reported limited or no VR or return to work support from health professionals. Typically, UC support lasted 2-8 weeks, with poor communication and co-ordination between rehabilitation providers. Mentor support for OTs appeared to increase fidelity. Service managers indicated ESSVR would enhance post-stroke services. ESSVR was valued by participants and was delivered with fidelity; implementation appeared to be facilitated by mentor support for OTs.

Background During the COVID-19 pandemic, complex interventions being evaluated in randomised controlled trials were often rapidly adapted from in-person to remote delivery. Such adaptations to intervention delivery have the potential to cause unintended consequences and affect important aspects of trial generalisability and interpretation. This scoping review aimed to identify the ‘lessons learned’ from trialists who adapted and remotely delivered a complex intervention within a trial because of the COVID-19 pandemic. Gaining a better understanding of trialists’ experiences of adapting interventions for remote delivery will identify where more in-depth investigation and guidance is needed. Methods The Joanna Briggs Institute (JBI) scoping review guidelines were followed. The search was developed for MEDLINE and adapted for Web of Science, PsycINFO, EMBASE, and Cochrane. Data were extracted on study characteristics, methods reported to adapt interventions, and the challenges and facilitators of the process of adaptation and remote intervention delivery. Data on remote intervention delivery were organised using the upper level of the Behaviour Change Intervention Ontology. Results Fifteen articles were eligible for inclusion describing insights from 16 randomised controlled trials, across a range of populations and trial designs. Most discussion focused on challenges and facilitators of the remote delivery of the complex intervention. These included privacy and safety concerns of intervention delivery within the home setting, and technological issues of remote delivery via video call. The most frequently reported facilitator was the use of an environmental inventory before intervention delivery to check the space in which participants were located, and the materials available to them. Conclusion Suitability of an intervention for remote delivery depends not only on whether it is originally delivered via a digital technology, but also the extent to which it requires human facilitation and support. Privacy and safety concerns in the home environment could impact trial participation in a remotely delivered intervention. Further research is needed to explore how trialists can effectively prepare for and manage the challenges of remote intervention delivery. Guidance developed to support adaptation of an intervention for remote delivery within a trial should be specific to the mode of delivery used.

Background Older adults are the most sedentary and fastest-growing demographic, yet adults aged ≥ 75 years are underrepresented in sedentary behaviour research. This study qualitatively explored how this age group perceives sedentary behaviour, the activities they perform in sitting and standing, and the barriers and facilitators to reducing their sedentary behaviour. Methods Four focus groups were conducted with a consistent group of 6 community-dwelling older adults aged ≥ 75 years from West Yorkshire were held between October-December 2022. Audio recordings and focus group notes were transcribed verbatim and an inductive and deductive thematic analysis was conducted. The activities performed in sitting and standing were charted to the ecological model of sedentary behaviour, and barriers and facilitators to reducing sedentary time were charted to the Capability Opportunity Motivation-Behaviour (COM-B) framework. Results Participants were largely unaware of their sedentary behaviour or the associated health risks. Sitting activities were predominantly leisurely in nature, and occurred in older adults’ homes. Barriers and facilitators to reducing sedentary behaviour were mapped to the COM-B model. Key influences included physical and mental health, environmental constraints, social support, ingrained routines, and limited awareness of the health impacts of prolonged sitting. Analytical themes included the perceived progression of sedentary behaviour throughout older adulthood; the impact of prolonged sitting on sleep; and the role of social connectedness in reducing sedentary time. Conclusions This study provided insights into older adults’ reports of sedentary behaviour progressing throughout older adulthood. When compared to the wider literature, sedentary behaviour in adults aged ≥ 75 years present similarly to a younger subset of older adults with regards to the activities performed in sitting, and the barriers and facilitators to reducing their sedentary time. However, the activities performed in sitting may be performed for longer, and the barriers to reducing sedentary behaviour may present more frequently. Social support appears valuable when attempting to reduce sedentary time, however, further research is necessary to explore the views of older adults who are socially isolated.

Background Older adults are the fastest-growing and most sedentary group in society. As sedentary behaviour is associated with deleterious health outcomes, reducing sedentary time may improve overall well-being. This mixed-methods systematic review aimed to systematically review quantitative and qualitative studies examining interventions to reduce sedentary behaviour in community-dwelling older adults (aged ≥ 65 years). Methods Medline, Embase, Cochrane Central Register of Controlled Trials, Web of Science, Cinahl, SportDiscus, and PEDRO were searched from inception to July 2025. We included quantitative studies (randomised-controlled trials (RCTs) and cluster RCTs), qualitative studies (semi-structured interviews or focus groups), and mixed-method studies exploring interventions to reduce sedentary behaviour in community-dwelling older adults. Studies were appraised using the Mixed Method Appraisal Tool. Quantitative evidence was meta-analysed; qualitative evidence was thematically synthesised, with both combined in a mixed-method synthesis. The Behaviour Change Techniques employed were charted and analysed. Results Fifty-six studies (16 RCTs, 30 qualitative, and 10 mixed-method studies) were included. When pooled, interventions reduced sedentary behaviour by 27.53 min/day (95% CI: − 57.43 to 2.37), with greater reductions observed via self-report (–83.65 min/day) than device measures (–11.61 min/day). Using ≥ 11 BCTs (-24.01 min/day) was more effective than using 1–10 ( 9.24 min/day). Analytical themes included what sitting means to older adults, expectations of ageing, and social influence in older adults. The mixed-method synthesis identified that existing interventions are limited by recruited samples that are not representative of the wider population of older adults, and intervention design and outcome measurement selection that is not consistent with older adults’ priorities. Conclusions Interventions to reduce sedentary behaviour in community-dwelling older adults are somewhat effective at reducing sedentary time. Future research should focus on inclusive recruitment strategies to recruit underrepresented populations, incorporate outcome measures valued by older adults, and align intervention content with their preferences. PROSPERO registration number CRD42021264954.

In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. The study is registered with the ISRCTN registry (ISRCTN91989345).

A key goal for working age stroke survivors is to return to work, yet only around 50% achieve this at 12 months. Currently, there is limited evidence of effectiveness of early stroke-specialist vocational rehabilitation (ESSVR) interventions from randomised controlled trials. This study examined fidelity to ESSVR and explored social and structural factors which may have influenced implementation in the RETurn to work After stroKE (RETAKE) randomised controlled trial. Mixed-methods process evaluation assessing intervention fidelity and incorporating longitudinal case-studies exploring stroke survivors' experiences of support to return to work. Normalisation Process Theory, and the Conceptual Model for Implementation Fidelity, informed data collection and analysis. Sixteen sites across England and Wales participated in RETAKE. Forty-eight occupational therapists (OTs), supported by 6 mentors experienced in vocational rehabilitation (VR), delivered the intervention (duration 12 months) between February 2018 and April 2022. Twenty-six participants (15 ESSVR, 11 usual care (UC)) were included in longitudinal case-studies. An additional 18 participants (8 ESSVR and 10 UC) were interviewed once. Nineteen OTs, 6 mentors and 19 service managers were interviewed. Fidelity was measured for 39 ESSVR participants; mean fidelity score was 78.8% (SD:19.2%, range 31-100%). Comparison of the experiences of ESSVR and UC participants indicated duration and type of support to return to work were perceived to be better for ESSVR participants. They received early, co-ordinated support including employer liaison and workplace adjustments where appropriate. In contrast, UC participants reported limited or no VR or return to work support from health professionals. Typically, UC support lasted 2-8 weeks, with poor communication and co-ordination between rehabilitation providers. Mentor support for OTs appeared to increase fidelity. Service managers indicated ESSVR would enhance post-stroke services. ESSVR was valued by participants and was delivered with fidelity; implementation appeared to be facilitated by mentor support for OTs.

BackgroundLow-dose amitriptyline, a tricyclic antidepressant (TCA), was superior to placebo for irritable bowel syndrome (IBS) in the AmitripTyline at Low-dose ANd Titrated for Irritable bowel syndrome as Second-line treatment (ATLANTIS) trial.ObjectiveTo perform post hoc analyses of ATLANTIS for predictors of response to, and tolerability of, a TCA.DesignATLANTIS randomised 463 adults with IBS to amitriptyline (232) or placebo (231). We examined the effect of baseline demographic and disease-related patient characteristics on response to amitriptyline and the effect of amitriptyline on individual symptoms and side effects by subtype.ResultsThere was a quantitative difference in amitriptyline effectiveness in those ≥50 years vs <50 on the IBS severity scoring system (IBS-SSS) (interaction p=0.048, mean difference in ≥50 years subgroup −46.5; 95% CI −74.2 to −18.8, p=0.0010), and subjective global assessment of relief (interaction p=0.068, OR in ≥50 years subgroup 2.59; 95% CI 1.47 to 4.55, p=0.0010), and those in the 70% most deprived areas of England compared with the 30% least deprived for a ≥30% improvement in abdominal pain (interaction p=0.021, OR in 70% most deprived subgroup 2.70; 95% CI 1.52 to 4.77, p=0.0007). Stronger treatment effects were seen in men, with higher Patient Health Questionnaire-12 scores, and with IBS with diarrhoea. Mean differences in individual IBS-SSS components favoured amitriptyline, and side effects were similar, across almost all IBS subtypes.ConclusionThese exploratory analyses demonstrate there are unlikely to be deleterious effects of amitriptyline in any particular IBS subtype and could help identify patients in whom amitriptyline may be more effective.Trial registration number ISRCTN48075063.

Background Older adults are the fastest-growing and most sedentary group in society. With sedentary behaviour associated with negative health outcomes, reducing sedentary time may improve overall well-being. Adults aged ≥ 75 years are underrepresented in sedentary behaviour research, and tailored strategies to reduce sedentary time may be warranted. The development of an intervention to reduce sedentary behaviour in adults aged ≥ 75 years using co-production and behaviour change theory is reported. Methods Four co-production workshops with community-dwelling older adults aged ≥ 75 years were held between October-December 2022. The intervention development process was informed by the Behaviour Change Wheel (BCW) and Theoretical Domains Framework (TDF). Audio recordings and workshop notes were iteratively analysed, with findings used to inform subsequent workshops. Results The co-production group consisted of six community-dwelling older adults aged ≥ 75 years and two researchers. The developed intervention consists of four components (activity monitoring, educational material, group sessions and researcher follow-up), maps to 24 behaviour change techniques and targets barriers to reducing sedentary time. Participants were receptive of the co-production process. Conclusions Integrating co-production with the BCW can provide several benefits, with the BCW providing structure to the intervention development process, and co-production increasing the likelihood of the developed intervention being viewed as feasible by older adults. Furthermore, coding intervention components to the BCW may further our understanding of what approaches are successful at influencing behavioural change. Transparent reporting of the intervention development process may benefit researchers developing interventions with older adults. Future research will pilot the co-produced intervention.

Background Researchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availability of routinely collected data for research, whether healthcare or administrative, has increased, and infrastructure funding has enabled much of this. However, challenges remain at all stages of a trial life cycle. This study, COMORANT-UK, aimed to systematically identify, with key stakeholders across the UK, the ongoing challenges related to trials that seek to use routinely collected data. Methods This three-step Delphi method consisted of two rounds of anonymous web-based surveys and a virtual consensus meeting. Stakeholders included trialists, data infrastructures, funders of trials, regulators, data providers and the public. Stakeholders identified research questions or challenges that they considered were of particular importance and then selected their top 10 in the second survey. The ranked questions were taken forward to the consensus meeting for discussion with representatives invited from the stakeholder groups. Results In the first survey, 66 respondents yielded over 260 questions or challenges. These were thematically grouped and merged into a list of 40 unique questions. Eighty-eight stakeholders then ranked their top ten from the 40 questions in the second survey. The most common 14 questions were brought to the virtual consensus meeting in which stakeholders agreed a top list of seven questions. We report these seven questions which are within the following domains: trial design, Patient and Public Involvement, trial set-up, trial open and trial data. These questions address both evidence gaps (requiring further methodological research) and implementation gaps (requiring training and/or service re-organisation). Conclusion This prioritised list of seven questions should inform the direction of future research in this area and should direct efforts to ensure that the benefits in major infrastructure for routinely collected data are achieved and translated. Without this and future work to address these questions, the potential societal benefits of using routinely collected data to help answer important clinical questions will not be realised.