BACKGROUND:Robotic systems are being increasingly used to assist with total knee replacement (TKR). Whether robotic systems improve outcomes after TKR is uncertain. We aimed to ascertain the clinical efficacy and cost-effectiveness of the Mako robotic-arm system compared with conventional instruments for TKR. METHODS:We conducted a participant-masked and assessor-masked pragmatic, superiority, randomised controlled trial at ten hospitals in Great Britain involving 33 surgeons. Patients with advanced knee osteoarthritis underwent TKR with conventional instruments (cTKR) or with the Mako robotic-arm-assisted system (rTKR). Key exclusion criteria were inflammatory arthropathy, previous fracture, or the need for complex implants. Participants were randomly assigned (1:1) through a remote computer system using minimisation by age, BMI, centre, surgeon, and primary knee compartment involved. Participants and assessors were masked through methods including using sham incisions, additional draping, and masked operation notes. The primary outcome was the Forgotten Joint Score (FJS) at 12 months after randomisation according to the intention-to-treat principle using a linear mixed-effects model. The prespecified target difference was 12 points. The trial is registered with ISRCTN (ISRCTN27624068), and long-term follow-up is ongoing. FINDINGS:Between Dec 21, 2021, and Dec 13, 2023, 807 patients were screened and 339 were randomly assigned: 168 to rTKR and 171 to cTKR. The median age was 68·8 years (IQR 61·3-75·2), 167 (49%) were female, and 172 (51%) were male. At 12 months, the mean FJS was 49·2 (SD 28·4; n=154) in the rTKR group and 50·2 (29·9; n=158) in the cTKR group. The adjusted mean difference was -1·5 (95% CI -7·5 to 4·5; p=0·62,) favouring cTKR. 16 participants in each group had one serious adverse event. INTERPRETATION:In this pragmatic trial, rTKR as delivered in routine practice was more costly than cTKR and did not provide a clinically meaningful patient benefit at 12 months after randomisation. The two groups had similar safety (ie, harms) profiles. FUNDING:UK National Institute for Health and Care Research Health Technology Assessment Programme.

Research question:Is surgery for early hip or knee osteoarthritis clinically effective and cost-effective? Background:Osteoarthritis is the most common joint disease worldwide costing between 1% and 2.5% of gross domestic product in developed countries. Once a hip or knee develops end-stage disease, arthroplasty surgery is highly successful in most patients. Treatment options are limited for early disease, and patients may fall into a 'treatment gap', despite having severe symptoms. Many surgical procedures are used to treat early osteoarthritis of the hip and knee, but the clinical and cost-effectiveness of these techniques remains unclear. Overall aim:To investigate the role of surgery in the management of early hip or knee osteoarthritis? Objectives:Use systematic review and evidence synthesis to determine the clinical effectiveness of current surgical interventions for early hip and knee osteoarthritis. Estimate the cost-effectiveness of these procedures using decision model analytic modelling. Create clinical treatment guidance and identify areas where new clinical research is required. Methods:The programme of work consisted of systematic review, evidence synthesis and health economic modelling for surgical treatments used for early hip and knee osteoarthritis. We divided treatments into four groups: (1) non-regenerative procedures, (2) regenerative procedures, (3) load-modifying procedures and (4) arthroplasty procedures. They were compared with non-surgical treatment following National Institute for Health and Care Excellence guidance. We used outcome measures that satisfied the Outcome Measures in Rheumatoid Arthritis Clinical Trials and Osteoarthritis Research Society International core outcome set for hip and knee osteoarthritis. Decision-analytic models were developed to assess the cost-effectiveness of treatment alternatives expressed as cost per quality-adjusted life-year gained. Results:The systematic review identified 61,098 studies, and our evidence synthesis identified a number of surgical techniques that have been used to treat early hip and knee osteoarthritis. However, we found very little meaningful evidence of the clinical efficacy for the majority of the surgical procedures. We only found seven randomised controlled trials and three non-randomised studies that compared a surgical technique to non-operative treatment. There were two surgical treatments that had limited but supportive evidence. Femoro-acetabular impingement is an early stage of hip osteoarthritis, and there is some evidence that arthroscopic chondroplasty provides patients with clinical relief of symptoms, above that seen with non-operative measures. In the knee, weaker evidence suggests arthroscopic debridement of osteoarthritic articular cartilage fragments may be of benefit, above non-operative measures. Health economic analysis suggests that both procedures may be cost-effective, but the evidence is again of low quality. Limitations:The original updated searches completed in January 2021, with a further search for randomised controlled studies completed in January 2025. Conclusions:There is a significant gap in the evidence base supporting surgical interventions in early hip and knee osteoarthritis. Limited evidence suggests that arthroscopic chondroplasty procedures may be effective in treating hip femoro-acetabular impingement and early knee osteoarthritis. A small number of randomised studies are in progress, but these studies do not encompass all procedures that are in use. Future work:The key recommendation for future work is that more high-quality comparative studies are required to establish if the surgical interventions that are currently used are effective. Study registration:This study is registered as PROSPERO CRD42019156444. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127398) and is published in full in Health Technology Assessment; Vol. 30, No. 56. See the NIHR Funding and Awards website for further award information.

Post-operative periprosthetic femoral fractures (POPFFs) following joint replacement surgery pose complex challenges, with differences in management and outcomes across healthcare facilities. However, there is limited published literature on such variability to inform improvement initiatives. This study aims to quantify the between-hospital variations in surgical management and short-term outcomes for POPFF. Administrative data from all 177 NHS hospital Trusts in England were analysed for patients aged 18 and over with a primary diagnosis of POPFF between April 2016 and December 2022. Patient demographics, comorbidities, procedures, in-hospital mortality, length of stay (LOS, dichotomised at the upper quartile, <23 days and ≥23 days), and emergency 30-day all-cause readmissions were extracted. Procedures were classified as revision with or without fixation, fixation alone, and neither procedure. Multilevel models with random intercepts for hospitals and funnel plots assessed the non-random variations between hospitals in procedures and outcomes. Variation was assessed before and after adjusting for patient age, sex and number of comorbidities. Among 39,035 hospitalised patients, 66% were female, with a median age of 82 years. Common comorbidities included hypertension (51.7%), arrhythmias (24.3%), and chronic pulmonary disease (18.2%). Hospital variation existed in treatment, with adjusted intraclass correlation coefficients for fixation without revision, revision, and no surgical procedure at 4%, 3.8%, and 2.4%, respectively. Funnel plots revealed many outliers for procedure choice and outcomes, though the numbers fell appreciably after adjustment. Among 177 hospitals after adjustment, nine (5.1%) exceeded the upper 95% control limit for fixation and 17 (9.6%) did so for revision, and LOS (n=25, 14.1%) and emergency 30-day readmission (n=7, 3.9%) but fewer for mortality (n=2, 1.1%). Between-hospital variation exists for the management of, and some short-term outcomes following, POPFFs in England. This warrants further explanation to better understand the reasons for this and how these may be overcome.

Background: Periprosthetic joint infection (PJI) is a major challenge for surgical teams and patients following an orthopedic surgical procedure. There is limited understanding on patient and health professional's perception of PJI. The aim of this study was to examine the literature to better understand the perspectives of patients, and those who manage PJI. Methods: Published and unpublished literature databases were systematically searched from inception to June 21, 2024. Qualitative studies reporting the perspectives of living with and managing PJI were included. Data were synthesized using a meta-ethnography approach and the GRADE-CERQual tool. Results: Of the 584 citations identified, 10 studies (n = 91 patients; n = 70 health professionals) met the eligibility criteria and were included. Three themes, all moderate-certainty evidence, were identified from the health professional data, including the following: (1) importance of PJI; (2) impact on health professionals; and (3) support for change. From the patient data, six themes on the basis of moderate-certainty evidence were identified: (1) psychological and social impact; (2) physical impacts; (3) relationship with health professionals; (4) relationship with others; (5) uncertainty over the future; and (6) support for change. A novel line of argument was developed offering third-order constructs, on the basis of first- and second-order themes. Conclusion: PJIs are perceived as devastating by both patients and health professionals. They impact on all aspects of a patient's physical, social and psychological health, each interacting on one another over the course of infection and management. Strategies to improve communication, multidisciplinary management, and personalization of care are advocated by both patients and health professionals to promote better outcomes.

OBJECTIVES:This systematic review aims to determine the effectiveness of ambulance transportation versus helicopter transportation on mortality for trauma patients. METHODS:A systematic review of published and unpublished databases (to August 2023) was performed. Studies, reporting mortality, for people who experienced trauma and were transported to a trauma unit by ambulance or helicopter were eligible. The Newcastle-Ottawa scale was employed to evaluate study quality. RESULTS:Of the 7,323 studies screened, 63 met the inclusion criteria. Thirty-two percent of these studies included patients with diverse injury types, while nine studies included patients across all age groups. The majority (92%) of the included data were retrospective in nature. Eighteen studies (28.57%) achieved the highest score on the Newcastle-Ottawa scale suggesting high-quality evidence. Seven studies examining 24-h mortality reported variable findings. Eighteen studies reported mortality without exact time points through adjusted analyses, 17 favored air transport. Air transport showed an advantage across all subgroups in the adjusted data, while the unadjusted data presented relatively similar outcomes between the two modes of transport. CONCLUSIONS:This systematic review found that adjusted analyses consistently favored air transport over ground transport. Unadjusted analyses showed no significant difference between the two modes of transport, except in specific subgroups. Further subgroup analyses revealed notable disparities between the two modalities, suggesting that these differences may be influenced by multiple factors. These findings highlight the need for further research to clarify the true impact of transport modality on trauma outcomes.

Objectives To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a pain management training intervention to support people with persistent musculoskeletal pain and their informal carers.Design Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.Setting National Health Service (NHS) providers in four English hospitals.Participants Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.Intervention Control: usual NHS care. Experimental: usual NHS care plus a carer-patient pain management training intervention (JOINT SUPPORT), comprising five, 1-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.Randomisation Central randomisation was computer-generated (2:1 Experimental:Control), stratified by hospital and patient-participant age (≤65 years). There was no blinding.Main outcome measures Data collected at baseline and 3 months post-randomisation included screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.Results A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.Conclusions The JOINT SUPPORT intervention was acceptable to patient-carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.Trial registration number ISRCTN78169443.Data availability statement The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.

Aims:The primary aims were to determine what outcome domains, outcome measurement instruments, and outcome measurement timepoints are reported in randomized controlled trials (RCTs) involving people with patellar dislocations. The secondary aims were to determine what primary outcomes were used and how a recurrent patellar dislocation was defined when this was used as an outcome. Methods:We searched MEDLINE, Embase, CINAHL, the Cochrane Database of Controlled Trials, and trial registries (last search: January 2024) for RCTs evaluating treatments for people with a patellar dislocation irrespective of age or sex. We identified the unique outcomes in included studies and mapped these onto the World Health Organization's International Classification of Functioning, Disability and Health (WHO ICF) framework to identify the measured domains. We synthesized results into tables, figures, and text. A critical appraisal of included studies was not required for this systematic review. Results:From the 70 included studies, we identified 141 unique outcomes. The most commonly used unique outcome was a recurrent ipsilateral patellar dislocation (used in 55 studies), but only 17/55 studies (31%) reported how this was defined (i.e. the criteria required for a recurrent ipsilateral patellar dislocation event to be recorded). Unique outcomes mapped onto 66 second-level domains of the WHO ICF framework, and 56% (593/1,052) in the 'activities and participation' domain. Included studies used 42 different patient-reported outcome measures (PROMs), most commonly the Kujala Patellofemoral Score (71%, 50/70 studies), but 28 PROMs (60%) were used only once. In all, 31 different primary outcomes were identified from 47 included studies, with 14 primary outcomes (45%) used only once among included studies. The Kujala Patellofemoral Score was also the most common primary outcome (38%, 18/47 studies). Outcome measurement timepoints varied, but the most common timeframe for primary outcome measurement was > one to three years (46%, 16/35 studies that provided data). Conclusion:The variability in the outcome domains, PROMs, and primary outcomes measured in RCTs evaluating patellar dislocation treatments highlights that a core outcome set is needed. This process is underway and is being informed by this systematic review's findings.

ObjectiveTo investigate the experience of people with shoulder osteoarthritis and their perception of non-surgical management in the U.K. National Health Service (NHS).DesignQualitative design, using semi-structured telephone interviews. Two authors (SL and MM) performed coding and theme development following principles of reflexive thematic analysis.SettingPhysiotherapy services within three NHS trusts in England. Individual interviews were conducted with patients with a diagnosis of shoulder osteoarthritis.ParticipantsTen participants were recruited (age range 57-86 years; six females; five with bilateral shoulder osteoarthritis).ResultsParticipants reported significant pain, functional limitations, and emotional distress. Non-surgical management experiences varied, with some finding relief from steroid injections, analgesia, and physiotherapy, while others reported limited perceived effectiveness. All participants expressed a desire for more information and support. There were divergent views on the need for surgery.ConclusionThis is the first study to explore the experiences of people with symptomatic shoulder osteoarthritis who have received care within an NHS setting. It highlights the significant impact of shoulder osteoarthritis on daily life and the challenges faced in accessing appropriate care. Findings emphasise the need for patient-centred care, including education, support, information provision and consideration of psychosocial factors. Future research is required to develop an evidence-based guideline for non-surgical management of shoulder osteoarthritis.

Systematic Literature Review & Patient-Information Scoping Review To assess the evidence on prehabilitation and post-operative rehabilitation interventions for people undergoing surgery for degenerative cervical myelopathy (DCM) and to determine what publicly accessible information is provided to patients from the NHS surrounding DCM surgery. A systematic literature review was searched from inception to 19 May 2025. Studies reporting pain, function, disability or quality of life for prehabilitation or post-operative rehabilitation interventions for people undergoing DCM surgery were eligible. Downs and Black appraisal tool was used to assess study quality. Data were analysed in a narrative analysis. Secondary, a review of UK NHS Patient Information Documents (PID) was searched using a Google platform assessment. PID reporting prehabilitation or post-operative information for people awaiting DCM surgery were included. The type of information being provided were extracted and descriptive statistics were used to report frequency of information provision. From 5218 screened studies, six studies (n = 685) met the eligibility criteria. The evidence was low to moderate in quality. Rehabilitation offered demonstrated improved clinical outcomes but there was limited evidence compared to non-rehabilitation or superiority between different rehabilitation strategies. The PID review identified 38 documents. This indicates education and guidance is commonly offered on returning to work (68%), driving (76%) and normal activities of daily living (63%). There remains uncertainty on what should be and is offered to patients with DCM in respect to prehabilitation or post-operative rehabilitation. Robust clinical trial evidence on rehabilitation approaches for this population is needed. PROSPERO (CRD42024604184).

Cervical spine radiculopathy [CSR] is a complex condition that is challenging to diagnose. The assessment methods used by United Kingdom [UK] physiotherapists to diagnose CSR remain unclear. A mixed-methods explanatory sequential design was used to investigate the assessment strategies that UK Health and Care Professions Council HCPC physiotherapists use and the reasons behind this decision-making in clinical practice. Phase 1 of the mixed methods research [MMR] study was a national online survey. The 63 respondents reported that the most common assessment strategies included muscle strength [94%], light touch sensation [78%] and reflex testing [89%]. Phase 2 of the MMR study included 11 qualitative interviews with Phase 1 [survey] participants. Four themes were established: perception of role, service constraints, minimising risk, and understanding symptoms. Physiotherapists often explained decision making in practice is based upon individual and organisational barriers. The choices available to physiotherapists may be based on cost, departmental knowledge and skill or convenience. However, the best available evidence suggests that physiotherapists should continue to use a biopsychosocial approach when establishing a CSR diagnosis. Physiotherapists should continue to embrace all assessment strategies available and strive to enhance or change practice.

Background A high proportion of patients do not regain outdoor mobility after hip fracture. Rehabilitation explicitly targeting outdoor mobility is needed to enable these older adults to recover activities which they value most. The overarching aim of this study is to determine the feasibility of a randomised controlled trial which aims to assess the clinical- and cost-effectiveness of an intervention designed to enable recovery of outdoor mobility among older adults after hip fracture (the OUTDOOR intervention). Methods This is a protocol for a multi-centre pragmatic parallel group (allocation ratio 1:1) randomised controlled assessor-blinded feasibility trial. Adults aged 60 years or more, admitted to hospital from- and planned discharge to- home, with self-reported outdoor mobility in the three-months pre-fracture, surgically treated for hip fracture, and who are able to consent and participate, are eligible. Individuals who require two or more people to support mobility on discharge will be excluded. Screening and consent (or consent to contact) will take place in hospital. Baseline assessment and randomisation will follow discharge from hospital. Participants will then receive usual care (delivered by physiotherapy, occupational therapy, or therapy assistants), or usual care plus the OUTDOOR intervention. The OUTDOOR intervention includes a goal-orientated outdoor mobility programme (supported by up to six in-person visits), therapist-led motivational dialogue (supported by up to four telephone calls), supported by a past-patient led video where recovery experiences are shared, and support to transition to independent ongoing recovery. Therapists delivering the OUTDOOR intervention (distinct from those supporting usual care) will receive training in motivational interviewing and behaviour change techniques. Baseline demographics will be collected. Patient reported outcome measures including health related quality of life, activities of daily living, pain, community mobility, falls related self-efficacy, resource use, readmissions, and mortality will be collected at baseline, 6-weeks, 12-weeks, and 6-months (for those enrolled early in the trial) post-randomisation. Exercise adherence (6- and 12- weeks) and intervention acceptability (12-weeks) will be collected. A subset of 20 participants will also support accelerometery data collection for 10 days at each time point. Dissemination The trial findings will be disseminated to patients and the public, health professionals and researchers through publications, presentations and social media channels. Trial registration The trial has been registered at ISRCTN16147125. Protocol version 3.0.

PURPOSE:Synthetic augmentation (SA) in anterior cruciate ligament reconstruction (ACLR) aims to enhance graft durability, but its benefits remain unclear. To evaluate whether SA in ACLR improves return-to-sport (RTS) rates, reduces graft failure, enhances patient-reported outcomes (PROs) and varies in effectiveness across materials and techniques. METHODS:A systematic search of five databases was conducted until February 2025. Comparative studies were pooled using Hedges' random-effects meta-analysis with subgroup analysis based on materials and publication year. Non-comparative studies were analysed narratively. Risk of bias was assessed using the Risk of Bias in Non-randomised Studies of Interventions and the Cochrane risk-of-bias tools for randomised studies. Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence. RESULTS:Forty-seven studies were included (n = 4289): 7 randomised and 40 non-randomised studies (21 comparative; 19 non-comparative). SA systems included InternalBrace (FiberTape, 16 studies), Ligament Augmentation and Reconstruction System (polyester, 5), Ligament Augmentation Device (polyethylene, 18) and other materials (8). GRADE assessment showed moderate-certainty evidence for improved mid-term RTS rate from eight studies (odds ratio [OR]: 1.58; 95% confidence interval (CI): 1.12-2.22; N = 716; I2 = 0%; p = 0.01). Internal brace showed a reduction in re-rupture rates in the long-term (OR: 0.17, 95% CI: 0.04-0.64; N = 218; I2 = 0%; p = 0.01); however, pooled analysis of all techniques showed no statistically significant difference. Contemporary studies showed a better return to sport rates with SA. PROs showed no clinically meaningful differences. Non-comparative studies showed low graft failure rates (<8.7% for InternalBrace; <16.4% for other SA), high RTS rates (>90% for InternalBrace; >56.7% for other SA) and satisfactory PROs. CONCLUSIONS:SA, particularly InternalBrace, may improve RTS rates and reduce re-rupture risk, though PROs remain inconclusive. Findings are limited by a moderate-to-serious risk of bias, emphasising the need for high-quality research. LEVEL OF EVIDENCE:Level III.

Aims To understand the experiences and decision-making practices of registered nurses when assessing acuity at triage in emergency departments.Design The study utilised a qualitative exploratory-descriptive design.Methods Purposive sampling recruited 11 registered nurses with triage experience from across the United Kingdom. Semi-structured online interviews, incorporating practice-based vignettes, were conducted between April and November 2024. Thematic analysis was selected to analyse the data.Results Three themes were identified: (1) Pressurised decisions, highlighting the effects of overcrowding, staffing shortages and operational burdens; (2) Holistic assessments, revealing the shift from structured to intuitive decision-making as nurses gain experience; and (3) Confidence, competence and emotional wellbeing, illustrating the psychological impacts of triage and the importance of experience and support.Conclusions This study provides novel insight into how triage nurses navigate acuity assessment in high-pressure environments. It shows how experience, training and institutional culture influence decision-making and wellbeing. It identifies key areas for targeted intervention.Implications for the Profession and/or Patient Care Triage nurses face substantial cognitive and emotional strain, which may compromise assessment quality and safety. Findings highlight the urgent need for structured triage training, protected time for assessment and access to wellbeing and peer support systems.Impact What problem did the study address?: A need for current literature exploring the practices and experiences of triage nurses. What were the main findings?: Triage nurses experience significant environmental and emotional pressures, develop decision-making strategies through experience and require enhanced training and support to ensure safe, effective care. Where and on whom will the research have an impact?: Findings are relevant to emergency departments internationally, triage nurses, nurse educators and healthcare leaders.Reporting Method This study adheared to COREQ reporting guidelines, and a copy of the checklist is attached as Data S1.Patient or Public Contribution This study did not include patient or public involvement in its design, conduct, or reporting.

INTRODUCTION:Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work. METHODS AND ANALYSIS:Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION:The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist. TRIAL REGISTRATION NUMBER:ISRCTN13855775.

OBJECTIVE:To 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). DESIGN:Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio. SETTING:Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community. PARTICIPANTS:Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture. INTERVENTIONS:Usual 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 MEASURES:Primary 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. RESULTS:In 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. CONCLUSIONS:The 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 NUMBER:ISRCTN28376407.

Background The foot and ankle are frequently affected in rheumatic and musculoskeletal diseases (RMDs), yet there is a lack of high-quality evidence to determine the effectiveness of treatments. Outcomes in research are often inconsistently measured, impeding evidence synthesis. Additionally, clinical decisions are based on research outcomes, but these are not always regarded as important by people with RMDs. This study aimed to determine domains of importance to people with RMDs who have experienced foot and ankle disorders, and aid in developing a standardised core outcome set (COS) to address these issues. Methods Participants from four continents (Europe, Africa, Australia, North America) were recruited to semi-structured interviews through clinical departments and electronic mailing lists. Analysis was conducted using a mixed deductive/inductive approach to the framework method. Patient research partners co-produced the interview schedule and recruitment materials, and co-interpreted results. Results Fifty-six participants (age range 27 to 76 years; 66 % female), with foot and ankle disorders in a variety of RMDs (including inflammatory arthritis, osteoarthritis, crystal arthropathies, connective tissue diseases), were interviewed. Sixteen domains were described by participants: pain, physical function, fatigue, deformity, skin and nail health, swelling, temperature, numbness, poor circulation, cramping, activities/participation, footwear impact, psychological impact, sleep, healthcare utilisation and personal expenses. Most domains were considered important to participants regardless of RMD or geographic location. Conclusions Foot and ankle disorders have far-reaching consequences for people with RMDs. This large qualitative study provides a foundation for achieving international consensus on a core outcome set for foot and ankle disorders in RMDs, to improve the quality of evidence demonstrating effectiveness of treatments.

BACKGROUND:Degenerative cervical myelopathy (DCM) is a condition of symptomatic cervical spinal cord dysfunction secondary to degenerative changes causing mechanical compression. Neurorehabilitation refers to an integrated, multidisciplinary care programme that aims to optimise function following a nervous system disorder. Neurorehabilitation is standard of care following many neurological conditions. However, this is not widely the case for patients with DCM. This work aimed to characterise current inpatient perioperative rehabilitation provision for patients with DCM who underwent surgical management at a single tertiary centre. METHODS:In this retrospective service evaluation, routine data were collected from electronic healthcare records for patients who had undergone surgery for DCM in a single tertiary neurosciences centre since 2014 (n = 593). Data were analysed for patient demographics, operative management, complications, and evidence of perioperative inpatient rehabilitation. Outcomes were assessed using the modified Japanese Orthopaedic Association (mJOA) score. RESULTS:Mean patient age was 62.7 years at surgery; 58.8 % (349/593) were male. The most common surgery was an anterior cervical discectomy and fusion (62 %, 349/593); overall complication rate was 6.1 % (36/593). Mean hospital stay was 5.6 ± 10.3 days; modal stay was one day. Sixty-seven percent (398/593) of patients received perioperative rehabilitation with a mean of 4.8 sessions per patient. Physiotherapy (64 %, 380/593; mean 2.4 sessions) and occupational therapy (27 %, 160/593; mean 1.2 sessions) were the most common forms of rehabilitation. The average wait for therapy to start was 1.4 days. A total of 30 % (178/593) of patients had an mJOA assessment preoperatively: 99 patients had severe DCM, 59 moderate DCM, and 20 mild DCM. Mean preoperative mJOA score was 11.20; mean post-operative mJOA score at one year was 12.95 (p < 0.01). There was no statistically significant difference in change in mJOA score for patients who received perioperative rehabilitation and those who did not (p = 0.32). A greater proportion of patients with severe DCM received physiotherapy (82 %, 81/99) compared to those with moderate (73 %, 43/59) and mild DCM (55 %, 11/20) (p = 0.03). CONCLUSION:Neurorehabilitation has been predicted to optimise functional recovery following decompressive surgery for DCM, however its exact role and what it should constitute remains undefined. This service evaluation has highlighted the need to improve understanding of the provision of perioperative rehabilitation and use scoring systems to quantitatively determine outcomes. Future studies should prospectively investigate the efficacy of DCM rehabilitation.

Aims:Postoperative periprosthetic femoral fractures (POPFFs) following hip arthroplasty pose complex challenges, with differences in management and outcomes across healthcare facilities. However, there is limited published literature on such variability to inform improvement initiatives. This study aims to quantify the between-hospital variations in surgical management and short-term outcomes. Methods:Administrative hospitalizations data from all 177 NHS hospital Trusts in England were analyzed for patients aged 18 years and above with a primary diagnosis of POPFF between April 2016 and December 2022. Patient demographic characteristics, comorbidities, procedures, length of stay, in-hospital mortality, 30-day total mortality (in or out of hospital), and emergency 30-day all-cause readmissions were extracted. Multilevel models with random intercepts for hospitals and funnel plots assessed the non-random variations between hospitals in procedures and outcomes. Results:Among 39,035 hospitalized patients, 66% were female (n = 25,720), with a median age of 82 years (IQR 73 to 88). Hospital variation existed in treatment outcomes, with adjusted intraclass correlation coefficients for fixation without revision, revision, and no surgical procedure of 4.0%, 3.8%, and 2.4%, respectively. Funnel plots revealed hospital outliers for procedure choice after adjusting for age, sex, and number of comorbidities - among 177 hospitals, nine (5.1%) exceeded the upper 95% control limit for fixation and 17 (9.6%) did so for revision; outlier proportions were 14.1% for length of stay, 3.9% for emergency 30-day readmission, and 1.1% for mortality. Conclusion:Inter-hospital variation exists for the management and short-term outcomes following POPFFs in England. This warrants further explanation to better understand the reasons for this.

Background Hip fracture has a substantial impact on the health, well-being and independence of patients and their families. In the 12 months after fracture, patients are at increased risk of cognitive and functional decline, admission to long-term care institutions and higher mortality. People with cognitive impairment are among the most vulnerable in acute hospital settings. They have lower short-term survival, with 24% mortality during admission. They are susceptible to suboptimal and inconsistent care standards that contribute to cognitive deterioration, increase risk of postoperative complications, prolong their length of stay and cause loss of independence. Objectives Establish best-practice from a systematic review of literature, observations of practice, perspectives of service users, carers, healthcare professionals, health service managers and experts in the field. Design the care pathway. Determine cultural/organisational changes necessary to implement and maximise adherence to the enhanced recovery pathway in hospital settings. Develop staff training and a training manual. Undertake a feasibility randomised controlled trial and collect outcomes to identify potential clinical and cost-effectiveness of the enhanced recovery pathway. Disseminate the findings and develop a definitive trial bid. Design A programme to develop an enhanced recovery pathway for people with hip fracture and cognitive impairment, tested for implementation and refined in the clinical environment. This refined enhanced recovery pathway was then tested in a feasibility study in 10 hospitals across the UK. Setting Acute care. Participants Hospital staff, people with cognitive impairment and hip fracture, carers and national and international experts in hip fracture or dementia. Interventions An enhanced recovery care pathway with checklist and an implementation process. Main outcome measures Mortality, patient and carer quality of life, cognition, activities of daily living. Data sources Clinical trial. Results A total of 284 participants were recruited, 132 to the PEFECT-ER intervention arm and 150 to the control arm, had good retention in the study and provided data for analysis. There was no evidence of any systematic between group difference at either the point of discharge from hospital or at 1-month follow-up. However, at 3 months, a relatively small effect of around one quarter of a standard deviation (0.071 units), was evidenced with respect to the health-related quality of life of the patient based on the EuroQol-5 Dimensions, five-level version by proxy in the intervention group (95% confidence interval 0.018 to 0.124; p = 0.009). A difference of 0.099 units in favour of the intervention group was also seen at the 6-month follow-up (95% confidence interval 0.001 to 0.198; p = 0.047). ‘Timed Up and Go’ and the Suitable Informant EuroQol-5 Dimensions, five-level version showed a no statistically significant difference except the model for length of stay. Those individuals in the intervention group had significantly longer lengths of stay, on average 1.22 times longer (95% confidence interval 1.02 to 1.45; p = 0.028). Mortality was similar in both groups, with a 6.1% mortality rate by 30 days post surgery. The process evaluation found that patients and carers were unable to comment on receiving the intervention. Limitations This was a feasibility study and was not designed as a definitive evaluation of the intervention. Lack of direct access to patient notes meant that researchers were unable to verify the Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery check listing results. The relationship between changes in documentation of practices and changes in care practices is also unclear. Patient and suitable informants did not assist understandings of implementation, mechanisms of action or experiences of interacting with the intervention. Client Services Receipt Inventory data collection burden was an issue. Conclusions The Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery feasibility trial demonstrated mean recruitment of 1.87 participant per centre per month. Retention at 1 month was over 80% and at 6 months approximately 50%. This information is useful for those wishing to design a definitive clinical trial. Although 30-day mortality was the same in both groups, the potential for reduction, by Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery being implemented, exists from cumulatively increased good practices across a range of care domains. To compare longer-term survival of patients who received the intervention, we would recommend measuring 3-month (110-day) mortality in addition to 30-day mortality. These data are readily available from National Hip Fracture Database and are thus ideal for efficient trial design. Client Services Receipt Inventory can be reduced for a definitive trial, removing equipment questions and some community health use questions. Qualitative interviews with Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery trial patient and carer should not take place. Future work Work to date shows that the intervention pathway for Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery required considerable input from champions for delivery. We are exploring further funding options to facilitate work to understand these mechanisms and further test, pilot and produce the Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery manual. Trial registration This trial is registered as Current Controlled Trials ISRCTN99336264. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: DTC-RP-PG-0311-12004) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 1. See the NIHR Funding and Awards website for further award information. Plain language summary What was the problem? Hip fracture and thought/memory (‘cognitive’) impairments, such as dementia and delirium, are major challenges for older patients, their families/carers and the National Health Service and social care. The outcomes of medical treatment for elderly patients with hip fracture are often poor, and worse when patients have memory and thinking problems. There is little research on how best to look after this patient group in hospital. Our previous work shows that patients, families, carers and staff repeatedly seek more sensitive ways to look after this patient group. Staff have also highlighted the need for training to help them work more appropriately to meet these patients’ needs. What did we do? We have created, adapted and piloted a set of care actions called Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery. Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery comprises a best practice checklist, a staff training manual, staff time to put the checklist into practice and to train colleagues, and a process to improve care of this patient group continuously. We tested Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery in five hospitals and asked whether staff found it acceptable. We wanted to find out if Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery could be used in a bigger trial, testing whether Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery improved outcomes for older people with hip fracture and memory problems. What did we find? We found that Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery was practical to use, both in the trial and by ward staff. Some measures we planned to use to calculate its costs were not completed by enough people to analyse in the study, suggesting that a future trial should have different measures. We found that measuring the number of people dying and people’s quality of life should be considered for the trial. What does this mean? Our evidence suggests that Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery can be used in hospitals and was acceptable to staff. There remains a need for a larger evaluation to investigate whether Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery provides benefit for this patient group. Scientific summary Text in this section reproduces material from Cross JL, Hammond SP, Shepstone L, Poland F, Henderson C, Backhouse T, et al. PERFECTED enhanced recovery pathway (PERFECT-ER) versus standard acute hospital care for people after hip fracture surgery who have cognitive impairment: a feasibility cluster randomised controlled trial. BMJ Open 2022;12:e055267. https://doi.org.uea.idm.oclc.org/10.1136/bmjopen-2021-055267. This article is distributed under the terms of the Creative Commons Attribution 4.0 International Licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution and reproduction in any medium, provided that you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence and indicate whether changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0) applies to the data made available in this article unless otherwise stated. The text below includes minor additions and formatting changes to the original text. Background This programme of research aimed to develop a best practice care pathway for people with dementia and hip fracture in hospital using the enhanced recovery framework. As the programme progressed, the intervention was adjusted to include all people with cognitive impairment (CI) as we learnt about implementation in practice. Objectives What is the best care practice for people in hospital with dementia who fracture their hip? [work package (WP) 1 phases 1–4] Can an optimised care pathway Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery (PERFECT-ER) be developed for people in hospital with dementia who fracture their hip? (WP1 phase 5) What are the staff training and cultural/organisational changes required to implement and maximise adherence to the optimised care pathway-enhanced recovery pathway (PERFECT-ER) in hospital settings? (WP2) What are the components of a training manual for the enhanced recovery pathway (PERFECT-ER) promoting cultural and organisational changes and maximising adherence? (WP2) What is the feasibility of undertaking a randomised clinical trial (RCT) to assess the clinical and cost-effectiveness of the enhanced recovery pathway (PERFECT-ER) to inform a definitive RCT? (WP3) Methods Work package 1: evidence for best practice This WP generated evidence for best practice from peer-reviewed and grey literature including access to national and international initiatives. We undertook a Cochrane review (CRD42012002047; WP1, phase 1a and b). We collected front-line national and international healthcare professional perspectives on best practice, current practice and explanations for implementation gaps between ‘best’ and ‘current’ practice (WP1, phase 2). We undertook observations of care of delivery (WP1, phase 3) to understand ‘usual care’ and collected the views and opinions of patients, carers and healthcare professionals of regarding current care (WP1, phase 4). From WP 1 phases 1–4 we identified and synthesised components to inform consensus development events attended by a number of experts (both by profession and experience) to develop the PERFECT-ER checklist (WP1, phase 5). Work package 2: optimising care for patients with dementia and hip fracture We used an action research approach, with a mixed-methods case study design to study implementation on an orthopaedic ward in each of three hospitals, using a series of plan, do, study, act (PDSA) cycles. Work package 3: feasibility trial We undertook a feasibility, multicentre, cluster RCT with integral economic evaluation. In line with Medical Research Council guidance for complex interventions, we also conducted an integrated multimethod multiperspective (from patients, suitable informants and NHS professionals) process evaluation. The trial ran from November 2016 to August 2018 in 11 hospitals in England and Scotland. Results (research findings) Work package 1 key findings Work package 1 phase 1a Our systematic review indicated that there was insufficient quality research on the rehabilitation of people living with CI following hip fracture surgery. Of the literature reviewed, the majority focused on people with mixed CI status and/or people with CI and hip fracture as a subgroup of larger studies. Studies lacked power to detect differences between intervention groups. The review suggested that models of rehabilitation could decrease the length of hospital stay and reduce admissions to care. No cost-effectiveness studies were located. We found that people living with CI are at greater risk of postoperative complications and higher mortality 12 months postoperatively. We also found uncertainty around rehabilitation provision, with no guidelines based on UK or international policy on how to deliver care to people living with CI following hip fracture. Components of enhanced care identified included screening for delirium and assessing pain for people with CI and hip fracture. Work package 1 phase 1b Our Freedom of Information Act survey highlighted the policy priorities that NHS trusts emphasised for people with dementia and hip fracture in March 2014. Numerous hospitals disclosed global dementia strategies and geriatric acute hip fracture pathways. However, no hospital disclosed an integrated dementia and hip fracture pathway or other documentation. Major themes affecting care elements were identified: antipsychotics, behaviours that challenge, cost consequences, communication (between staff and patients, between staff and carers/family, between staff), consenting, constipation, delirium, dementia assessment, deprivation of liberties, discharge processes, end-of-life care, falls, hydration, identification of patients with dementia, incontinence, involving carers, manual handling, minimising ward changes, non-pharmacological interventions, nutrition, pain relief, pressure ulcers, safeguarding vulnerable adults, training in dementia care and ward environment. These themes were then aligned with corresponding elements described in the enhanced recovery after surgery literature (admission, preoperative, intraoperative, postoperative, rehabilitation, discharge). Work package 1 phase 2 The telephone survey investigated domestic and international healthcare professionals’ perspectives on the care pathways and costs, length of stay in hospital and discharge destinations for people with dementia and hip fracture. The participants identified diverse needs for patients with dementia in acute settings but supplied documentation that was largely dementia or hip fracture focused but not integrated. Participants described that training to provide colleagues with the skills to care for this patient group was generic and ‘tick box’. They also found that outcome metrics such as length of hospital stay did not help in recognising recovery in this patient group. The documents received through the survey were coded using a developed coding matrix to identify potential intervention components. This provided initial insights into what participants perceived as current and best practice. Implementation gaps they identified helped generate the observation topic guides used in WP1 phase 3. Work package 1 phase 3 Key themes identified specific interruptions (‘disjunctures’) in routines or planned sequences in caregiving as: Disruptions – when usual or expected practices were interrupted impacting on the ease with which staff manage care delivery. Discontinuities – when divisions in culture, spaces and timing interrupt the smooth delivery of tasks. Dispersions – occasions when environment artefacts [object(s) and/or people] are displaced from designated space. Work package 1 phase 4 The staff focus groups and interviews reported emotive experiences, fatigue and constraints that staff reported experienced on a daily basis. Many participants identified failing to deliver appropriate care to patients with dementia in several ways, including: lack of staff and/or time required combined organisational barriers care spaces not fit for these patients care needs. Carer experiences supported these staff views. Some carers felt under pressure to assist staff, whom they perceived as needing help, to relieve shortages. Carers did not view this as empowering them to produce co-delivered care. The patients were mostly full of praise for staff efforts, in improvising to meet ongoing disjunctures in workflow by re-prioritising tasks. Work package 1 phase 5 The intervention PERFECT-ER was developed through stakeholder consensus events. Work package 2 key findings In WP2 we identified common barriers, facilitators, underlying mechanisms and work of service improvement leads (SILs) and PERFECTED process leads (PPLs) entailed in embedding PERFECT-ER across distinct hospital settings. While this proved challenging, staff found different ways to implement changes within their settings. It became clear that the practices surrounding such changes could easily break down. Components of PERFECT-ER that aligned to context-specific motivations, including the National Hip Fracture Database (NHFD) best practice tariff or trust policies, were easier to implement and longer lasting. WP2 enabled us to refine the PERFECT-ER intervention and develop its training manual, understanding the requirements of the SIL, PPL roles and using the checklist as part of the PDSA cycle. This informed implementation aspects of the trial (WP3) and the process evaluation. Work package 3 feasibility key findings We recruited 282 participants, 132 from intervention sites and 150 from control sites. The average recruitment rates did not differ between intervention and control sites, ranging between 1.2 and 2.7 participants per month. Average recruitment of 1.87 per month contrasted with the expected 4 per site per month anticipated. There was no evidence of any systematic between group difference at either the point of discharge from hospital or at 1-month follow-up. At 3 months, however, a potential beneficial effect of the intervention over control was evidenced for patient health-related quality of life (HRQoL) based upon the EuroQol-5 Dimensions, five-level version (EQ-5D-5L) by proxy: those in the intervention group had a mean EQ-5D utility score 0.071 units higher than control [95% confidence interval (95% CI) 0.018 to 0.124; p = 0.009], a relatively small effect of around one quarter of a standard deviation. A difference of 0.099 units, in favour of the intervention group, was also seen at the 6-month follow-up (95% CI 0.001 to 0.198; p = 0.047). Examination of the residuals from each of the models appeared to show violation of the normal distribution assumption for the length of stay, ‘Timed Up and Go’ and the Suitable Informant EQ-5D-5L models. Logarithmic transformation was applied to these data and the models refitted. None then showed any statistically significant difference except the model for length of stay. The individuals in the intervention group had significantly longer lengths of stay, on average 1.22 times longer (95% CI 1.02 to 1.45; p = 0.028). Over the trial’s duration, 57 participants (20.2%) died. A higher rate of all deaths was observed in the intervention group than in the control group (22.7% vs. 18.0%). Death in hospital was determined from the NHFD data and only available for participants in England, thus excluding 59 Scottish participants. Eleven participants (3.9%) died in hospital, with a higher rate in the control group (4.7% vs. 3.0%). Seventeen (8 intervention, 9 control) patients were known to have died within 30 days of surgery and 52 (28 intervention and 24 control) within 6 months. Process evaluation The process evaluation demonstrated that, under particular conditions, the PERFECT-ER intervention package can be implemented in diverse NHS contexts. General barriers to implementation including: staffing issues, low staff morale, staff sickness, staff movement between wards and lack of senior staff, impacted negatively on implementation. However, the protected SIL resource, PDSA processes, networking, and using key staff members and trust processes, along with the resourcefulness, determination, commitment and ingenuity of SILs, PPLs and others with whom they worked, were facilitators. We demonstrated that implementing an intervention encouraging more standardised practice and its documentation to improve patient, carer and staff outcomes via consistently amalgamating marginal gains was welcomed, necessary and seen as valuable. Health economics Data completeness was comparable between suitable informant-reported (SIR) and hospital records but slightly higher in the SIR data. Comparing agreement in the data, we found sources agreed on ‘non-use’, but suitable informant over- and under-reporting of ‘use’ compared with hospital records did not follow a consistent pattern. Comparing SIR ‘hospital use’ over the 3-month periods pre-baseline and pre-6-month follow-up were identical at both assessments. Data suggest that sources yielded inconsistent estimates for inpatient days and for emergency department visits but more consistent estimates for outpatient attendances. Total hospital costs yielded inconsistent estimates. Individual items of resource use were relatively well completed, with missing rates below 12%. However, the cumulative impact of missing data decreased the availability of complete costs at all-time points. A combination of missing resource use and unpaid care data from participants/suitable informants completing the trial and high attrition rates led to small or very small samples available for calculating 6-month costs. Low completion of self-reported HRQoL instruments (EQ-5D-5L and DEMQOL) and attrition led to small samples available for calculating 6-month participant-reported quality-adjusted life-year (QALY). There were 64 intervention participants and 79 controls at 6 months but on combinations of societal costs and self-completed HRQoL measures, only 25 cases were available for analysis. In line with the original proposal, cost-effectiveness estimates were produced. The evidence of these analyses points to substantial uncertainty as to the size of the incremental cost-effectiveness ratios produced. No assumptions were made as to the costs and QALY of participants that had died during the trial; instead, complete cases were analysed. The mechanisms underlying incomplete data were not necessarily observed or recorded and so no imputation strategy was possible. Conclusions The PERFECT-ER feasibility trial demonstrated mean recruitment of 1.87 participant per centre per month. Retention at 1 month was over 80% and at 6 months approximately 50%. In patients with CI and hip fracture, we estimated that 10–20% died within 30 days of sustaining a hip fracture. Our data suggest that short-term mortality could be reduced with implementation of PERFECT-ER from a culmination of increased good practice across a range of care domains. Thirty-day mortality is more commonly used as an outcome measure in the evaluation of enhanced recovery pathways; discussion with the patient and public involvement group indicated that this was an appropriate primary outcome in future trials. The process evaluation found patients and carers unable to comment on receiving the intervention, so did not assist in answering questions about PERFECT-ER implementation. Equipment costs contributed little to overall costs and these questions should be removed. Hospital records-extracted data were used to estimate costs for use in the cost-effectiveness analyses presented here. These are the ‘gold-standard’ source compared with SIR data. However, records did not include information on hospital stays outside the trusts providing the records, so use of other hospitals might have been omitted. The feasibility PERFECT-ER trial provided valuable information and evidence to future work. Thirty-day post-surgery mortality is appropriate primary outcome for future trials, but to compare longer-term survival, we recommend also measuring 3-month mortality. In a definitive PERFECT-ER trial, patient and carer interviews should not be undertaken. Community health use questions should be reduced, removing health care that might be routine and little affected by the intervention, such as dentistry. We consider that hospital records extraction proformas and trial database design in a definitive trial could address potential shortcomings. We would not recommend comparing SIR and hospital records sources in a larger study. Trial registration This trial is registered as Current Controlled Trials ISRCTN 99336264. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: DTC-RP-PG-0311-12004) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 1. See the NIHR Funding and Awards website for further award information.

Background/Objectives: Friends and family members of people who are discharged from hospital after a fracture often take on caring roles, since these patients have reduced independence during recovery. Previous literature suggests that these individuals are rarely supported in their adoption of these roles. No studies have previously explored the use of carer training interventions to support friends/family members by health professionals in this setting. This survey study aimed to address this. Methods: A cross-sectional online survey was conducted among health professionals who treat people in hospital following fractures. Respondents were asked about the use of care training for friends/family members of people discharged from hospital after fracture, and whether a clinical trial would be useful to test such carer training interventions. Results: A total of 114 health professionals accessed the survey. Fifty respondents (44%) reported that carer training was not offered in their practice. When it was offered, respondents reported this was not consistently provided. Less than 12% of respondents reported offering carer training to most of their patients following a fracture. What was offered in these instances was largely based on education provision (69%), practical skills in exercise prescription (55%) and manual handling (51%). Ninety-eight percent of respondents reported that a clinical trial would be, or would potentially be, valuable to aid a change in practice to include carer training in routine clinical care. Conclusions: Carer training programmes are not routinely provided in clinical practice for people following a fracture. The results indicate that health professionals see a potential value in these programmes, but further research is recommended to provide an evidence base for these interventions.