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Objectives(1) To develop an intervention for to support patients diagnosed with an anterior cruciate ligament (ACL) rupture with decision-making regarding treatment. (2) To define evidence-based recommendations for the treatment of patients following an ACL rupture.DesignNominal group technique consensus study.SettingOnline meetings with patients and key stakeholders working and receiving treatment in the National Health Service, UK.ParticipantsConsensus meetings composed of eight voting participants and five non-voting facilitators. Voting participants included five clinicians, one outpatient therapy manager and two patients with experience in an ACL rupture and reconstructive surgery. Non-voting facilitators supported group discussions and/or observed study procedures. This included a clinical academic expert, two methodology experts and two patient representatives.MethodTwo online meetings were held. Pre-elicitation material was distributed ahead of the first meeting. Premeeting voting was conducted ahead of both meetings. A draft of the shared decision-making intervention and recommendations were shared ahead of the second meeting. Components were discussed and ranked for inclusion based on a 70% agreement threshold.ResultsThe meetings led to the development of a shared decision-making intervention to support treatment decision-making following an ACL rupture. The intervention includes two components: (1) a patient information leaflet and key questions diagram and (2) option grid. The evidence-based recommendations encompass core components of treatment reaching the 70% threshold agreed by the group. The recommendations cover: (1) advice and education, (2) exercise guidance, (3) intervention delivery, (4) outcome measure use and (5) shared decision-making.ConclusionThis study has successfully developed a shared decision-making intervention to support ACL treatment decision-making, ready for testing in a future feasibility study. Evidence-based recommendations for the treatment of patients following ACL injury, ready for testing in a National Health Service (UK) setting, are also presented.Trial registration number NCT05529511.

ObjectivesTo understand feasibility, acceptability and indicators of effectiveness of a shared decision-making (SDM) intervention with patients following an anterior cruciate ligament (ACL) rupture.DesignNon-randomised feasibility study with embedded qualitative interviews.SettingOrthopaedic and physiotherapy service at an acute National Health Service (NHS) Teaching Hospital in the Midlands, UK, between 29 January and 5 June 2024.ParticipantsPatients diagnosed with an ACL rupture following MRI.InterventionDelivery of a SDM intervention which comprised of two components: (1) patient information leaflet and (2) option grid.Outcome measuresThe primary outcome was to determine feasibility for a definitive trial using four outcomes: (1) recruitment rate, (2) fidelity of intervention delivery, (3) acceptability and (4) follow-up questionnaire completion. The secondary outcome was to explore indicators of the intervention’s effectiveness using quantitative data from patient reported outcome measures (acceptability questionnaire and satisfaction with decision scale) and qualitative data from patient and clinician interviews.Results21 patients were approached to take part in the study, 20 were recruited with a mean age of 32.2 (SD 9.7), 40% were female. The recruitment rate was 95.2%, fidelity of intervention 100%, acceptability 94% and follow-up questionnaire completion 100%. The mean overall satisfaction with decision scale score was 24.85/30 (SD 3.82). There were no adverse events. Data from qualitative interviews with patients (n=5) and physiotherapists (n=5) suggested the SDM was acceptable and appeared effective in: (1) supporting decision-making about treatment, (2) conversations between patients and clinicians, (3) improving patient knowledge, (4) providing patients with access to health language and (5) supporting patients to ask questions deemed important to them.ConclusionThe novel SDM intervention is acceptable to both patients and physiotherapists. Indicators of effectiveness explored through quantitative and qualitative data suggest the intervention to be beneficial to decision-making processes for patients and clinicians deciding on treatment following an ACL rupture. All four feasibility outcomes were achieved, indicating a full trial is feasible to run in the NHS.Trial registration numberISRCTN17801081.

ObjectivesThis study aimed to understand the lived experiences of patients on the anterior cruciate ligament reconstruction (ACLR) pathway up to 3 months before, 3 months after and 1 year after surgery. Study objectives were to explore (1) patient experiences of preoperative and postoperative treatment, (2) views of/involvement in prehabilitation and (3) sources and consistency of healthcare advice.DesignSemi-structured interviews analysed using reflexive thematic analysis.SettingMidlands, England.ParticipantsPurposive sample of 18 participants aged 18–45. Three identified as female and 15 as male. Participants’ ethnic origin was white (n=14), Indian (n=2), British Asian (n=1) and Pakistani (n=1). 10 participants were awaiting ACLR, six were 3months postsurgery and two were 1 year postsurgery.ResultsParticipants gave a rich account of ACLR pathway experiences discussing negative impacts of the injury, difficulties with navigating the pathway and making decisions about surgery. Interacting with healthcare professionals and managing the variety of resources, advice and opinions were also highlighted as challenges. Participants reflected on their preoperative journey accounting a wide spectrum of expectations and realities of returning to work and physical activity postoperatively. Prehabilitation was perceived to offer an advantage to recovery, mental well-being, injury knowledge, postoperative rehabilitation and supports a faster return to physical activity. Five themes were identified:Injury experience, impact and support.Navigating the treatment pathway.Sense making in the preoperative period.Uncertainty, expectations and reality of the postsurgical period.Balancing resources, advice and opinions.ConclusionThis study has illuminated patient experiences of the National Health Service (NHS) ACLR pathway, novel to the evidence base.The results highlight the perceived shortcomings in patient support. They also demonstrate the difficulty patients face when navigating the NHS system, communicating with clinicians, making decisions about treatment and managing conflicting sources of healthcare advice. These problems are more prominent than previously recognised in the literature.RegistrationClinicalTrials.gov Identifier: NCT05529511.

ObjectiveTo determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).DesignDefinitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.SettingParticipant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.ParticipantsPatients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.InterventionsUsual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.Primary and secondary outcome measuresPrimary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.ResultsIn total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI −1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.ConclusionsThe FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.Trial registration numberISRCTN28376407.

ObjectivesThis review aimed to identify mechanisms underlying participation in falls prevention interventions, in older adults with cognitive impairment. In particular we studied the role of motivation.DesignA realist review of the literature.Data sourcesEMBASE, MEDLINE, CINAHL, the Cochrane Library, PsycINFO and PEDRO.Eligibility criteriaPublications reporting exercise-based interventions for people with cognitive impairment, including dementia, living in the community.Data extraction and synthesisA ‘rough programme theory’ (a preliminary model of how an intervention works) was developed, tested against findings from the published literature and refined. Data were collected according to elements of the programme theory and not isolated to outcomes. Motivation emerged as a key element, and was prioritised for further study.ResultsAn individual will access mechanisms to support participation when they think that exercise will be beneficial to them. Supportive mechanisms include having a ‘gate-keeper’, such as a carer or therapist, who shares responsibility for the perception of exercise as beneficial. Lack of access to support decreases adherence and participation in exercise. Motivational mechanisms were particularly relevant for older adults with mild-to-moderate dementia, where the exercise intervention was multicomponent, in a preferred setting, at the correct intensity and level of progression, correctly supported and considered, and flexibly delivered.ConclusionMotivation is a key element enabling participation in exercise-based interventions for people with cognitive impairment. Many of the mechanisms identified in this review have parallels in motivational theory. Clinically relevant recommendations were derived and will be used to further develop and test a motivationally considered exercise-based falls intervention for people with mild dementia.PROSPERO registration numberCRD42015030169.

ObjectivesThe aim of this study was to refine a draft of the ACTiON FALLS LD programme based on the views of adults with an intellectual disability (AWID), carers and healthcare professionals (HCPs).Design, setting and participantsThe semistructured interview study included HCP as well as AWID and carers supporting AWID living in the community. Community settings included sheltered living, supported living, AWID living at home with family carers or independently. The interview study explored the first draft of the ACTiON FALLS LD programme as well as the wider falls management for AWID. Interviews with AWID were developed to include a range of approaches (eg, case studies, pictures) to support inclusive participation. Individual interviews were digitally recorded and transcribed. Researcher notes were used during interviews with AWID. All data were analysed using the principles of framework analysis.Results14 HCP, 8 carers and 13 AWID took part in the interview process. Five key themes were identified: programme components, programme design, programme approach, who would use the programme and programme delivery.ConclusionsThe views of AWID, HCP and carers showed the need to consider the impact of risk perception, anxiety and fear of falling in the adaption of the ACTiON FALLS programme. The programme needs to be accessible and support the inclusion of AWID in managing falls and ultimately fulfil the requirement for a proactive and educational tool by all.

ObjectivesThere is an emergent body of evidence supporting exercise therapy and physical activity in the management of musculoskeletal pain. The purpose of this study was to explore potential barriers and facilitators with patients and physiotherapists with patellofemoral pain involved in a feasibility randomised controlled trial (RCT) study. The trial investigated a loaded self-managed exercise intervention, which included education and advice on physical activity versus usual physiotherapy as the control.DesignQualitative study, embedded within a mixed-methods design, using semi-structured interviews.SettingA UK National Health Service physiotherapy clinic in a large teaching hospital.ParticipantsPurposively sampled 20 participants within a feasibility RCT study; 10 patients with a diagnosis of patellofemoral pain, aged between 18 and 40 years, and 10 physiotherapists delivering the interventions.ResultsIn respect to barriers and facilitators, the five overlapping themes that emerged from the data were: (1) locus of control; (2) belief and attitude to pain; (3) treatment expectations and preference; (4) participants’ engagement with the loaded self-managed exercises and (5) physiotherapists’ clinical development. Locus of control was one overarching theme that was evident throughout. Contrary to popular concerns relating to painful exercises, all participants in the intervention group reported positive engagement. Both physiotherapists and patients, in the intervention group, viewed the single exercise approach in a positive manner. Participants within the intervention group described narratives demonstrating self-efficacy, with greater internal locus of control compared with those who received usual physiotherapy, particularly in relation to physical activity.ConclusionsImplementation, delivery and evaluation of the intervention in clinical settings may be challenging, but feasible with the appropriate training for physiotherapists. Participants’ improvements in pain and function may have been mediated, in some part, by greater self-efficacy and locus of control.Trial registration number ISRCTN35272486; Pre-results.

IntroductionProximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.Methods and analysisProtocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks’ follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.Ethics and disseminationNational Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.Trial registration numberISRCTN28376407; Pre-results registered on 23 November 2018.

Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs) conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years) and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies) rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated.

ObjectivesRehabilitation interventions for older adults are complex as they involve a number of interacting components, have multiple outcomes of interest and are influenced by a number of contextual factors. The importance of rigorous intervention development prior to formal evaluation has been acknowledged and a number of frameworks have been developed. This review explored which frameworks have been used to guide the development of rehabilitation interventions for older adults.DesignSystematic scoping review.SettingStudies were not limited for inclusion based on setting.ParticipantsStudies were included that featured older adults (>65 years of age).InterventionsStudies were included that reported the development of a rehabilitation intervention.Primary and secondary outcome measuresData were extracted on study population, setting, type of intervention developed and frameworks used. The primary outcome of interest was the type of intervention development framework.ResultsThirty-five studies were included. There was a range of underlying medical conditions including mild cognitive impairment and dementia (n=5), cardiac (n=4), stroke (n=3), falls (n=3), hip fracture (n=2), diabetes (n=2), breast cancer (n=1), Parkinson’s disease (n=1), depression (n=1), chronic health problems (n=1), osteoarthritis (n=1), leg ulcer (n=1), neck pain (n=1) and foot problems (n=1). The intervention types being developed included multicomponent, support based, cognitive, physical activities, nursing led, falls prevention and occupational therapy led. Twelve studies (34%) did not report using a framework. Five frameworks were reported with the Medical Research Council (MRC) framework for developing and evaluating complex interventions being the most frequently cited (77%, n=17).ConclusionAt present, the MRC framework is the most popular for developing rehabilitation interventions for older adults. Many studies do not report using a framework. Further, specific guidance to assist this complex field of rehabilitation research is required.