Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2): a study protocol.

INTRODUCTION: Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective. METHODS AND ANALYSIS: The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 6, 12, 18, and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. TRIAL REGISTRATION NUMBER: ISRCTN87336549.

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

OBJECTIVE: To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. DESIGN: Pragmatic, multicentre, randomised controlled trial (ARTISAN). SETTING AND PARTICIPANTS: Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. INTERVENTIONS: One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. MAIN OUTCOME MEASURES: The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. RESULTS: 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). CONCLUSIONS: An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63184243.

UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol.

INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.

Improving mental healthcare access and experience for people from minority ethnic groups: an England-wide multisite experience-based codesign (EBCD) study.

BACKGROUND: Long-standing ethnic inequalities in access and mental healthcare were worsened by the COVID-19 pandemic. OBJECTIVES: Stakeholders coproduced local and national implementation plans to improve mental healthcare for people from minority ethnic groups. METHODS: Experience-based codesign conducted in four areas covered by National Health Service (NHS) mental health trusts: Coventry and Warwickshire, Greater Manchester, East London and Sheffield. Data were analysed using an interpretivist-constructivist approach, seeking validation from participants on their priority actions and implementation plans. Service users (n=29), carers (n=9) and health professionals (n=33) took part in interviews; focus groups (service users, n=15; carers, n=8; health professionals, n=24); and codesign workshops (service users, n=15; carers, n=5; health professionals, n=21) from July 2021 to July 2022. FINDINGS: Each study site identified 2-3 local priority actions. Three were consistent across areas: (1) reaching out to communities and collaborating with third sector organisations; (2) diversifying the mental healthcare offer to provide culturally appropriate therapeutic approaches and (3) enabling open discussions about ethnicity, culture and racism. National priority actions included: (1) co-ordination of a national hub to bring about system level change and (2) recognition of the centrality of service users and communities in the design and provision of services. CONCLUSIONS: Stakeholder-led implementation plans highlight that substantial change is needed to increase equity in mental healthcare in England. CLINICAL IMPLICATIONS: Working with people with lived experience in leadership roles, and collaborations between NHS and community organisations will be essential. Future research avenues include comparison of the benefits of culturally specific versus generic therapeutic interventions.

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.

Supportive Self-Management Program for People With Chronic Headaches and Migraine: A Randomized Controlled Trial and Economic Evaluation.

BACKGROUND AND OBJECTIVES: Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches. METHODS: This was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension-type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management program, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material. The primary outcome was headache related-quality of life using the Headache Impact Test (HIT)-6 at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data. RESULTS: Between April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyzed for primary outcome. There was no between-group difference in HIT-6 (adjusted mean difference = -0.3, 95% CI -1.23 to 0.67) or headache days (0.9, 95% CI -0.29 to 2.05) at 12 months. The Chronic Headache Education and Self-management Study intervention generated incremental adjusted costs of £268 (95% CI, £176-£377) (USD383 [95% CI USD252-USD539]) and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI -0.005 to 0.063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained. DISCUSSION: These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension-type headache with episodic migraine. TRIAL REGISTRATION INFORMATION: Registered on the International Standard Randomized Controlled Trial Number registry, ISRCTN79708100 16th December 2015 doi.org/10.1186/ISRCTN79708100. The first enrollment was April 24, 2017. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine.

Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial.

INTRODUCTION: Knee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated with higher mortality and inferior outcomes. With more young people presenting with knee OA and increasing life expectancy, there is an unmet need to postpone time to first KR. Knee joint distraction (KJD), the practice of using external fixators to open up knee joint space, is proposed as potentially effective to preserve the joint following initial studies in the Netherlands, however, has not been researched within an NHS setting. The KARDS trial will investigate whether KJD is non-inferior to KR in terms of patient-reported postoperative pain 12 months post-surgery. METHODS AND ANALYSIS: KARDS is a phase III, multicentre, pragmatic, open-label, individually randomised controlled non-inferiority trial comparing KJD with KR in patients with severe knee OA, employing a hybrid-expertise design, with internal pilot phase and process evaluation. 344 participants will be randomised (1:1) to KJD or KR. The primary outcome measure is the Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain domain score at 12 months post-operation. Secondary outcome measures include patient-reported overall KOOS, Pain Visual Analogue Scale and Oxford Knee Scores, knee function assessments, joint space width, complications and further interventions over 24 months post-operation. Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Research Ethics Committee (REC) and Health Research Authority (HRA). Trial results will be disseminated at clinical conferences, through relevant patient groups and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN14879004; recruitment opened April 2021.

Development of a single-session physiotherapy and self-management intervention for the treatment of primary traumatic anterior shoulder dislocation for the 'Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN)' multi centre RCT.

OBJECTIVE: Optimum physiotherapy management for people with a conservatively managed primary traumatic anterior shoulder dislocation is not known. The purpose of the ARTISAN trial is to compare the clinical and cost-effectiveness of a course of usual care physiotherapy with a single session of physiotherapy and self-management, the ARTISAN intervention. ARTISAN is a UK multi-centre, two-arm, parallel group, randomised controlled trial with 1:1 treatment allocation. DESIGN: The intervention was developed following the Medical Research Council framework for developing and evaluating complex interventions and will be reported in line with the template for intervention description and replication checklist (TIDieR) and the Consensus on Exercise Reporting Template (CERT). It was informed by published research, national clinical guidelines, current clinical practice and patient and public involvement. RESULTS: The ARTISAN intervention comprises education (Phase 1), progressive exercise (Phase 2 and Phase 3) and an optional return to sport component (Phase 4). Behaviour change strategies are embedded throughout intervention. The single session of physiotherapy is delivered by a chartered physiotherapist, within the first six weeks of injury, in an NHS outpatient setting. At the end of the initial session, paper-based booklets and/or a patient website with the same content are provided to participants to aid self-management and progression though the four phases of the trial intervention. CONCLUSION: The ARTISAN intervention was successfully implemented throughout the internal pilot and is suitable for testing in the subsequent definitive RCT ARTISAN trial. Trial Registration Number ISRCTN63184243.

Developing evidence-based guidance for assessment of suspected infections in care home residents.

BACKGROUND: The aim of this study was to update and refine an algorithm, originally developed in Canada, to assist care home staff to manage residents with suspected infection in the United Kingdom care home setting. The infections of interest were urinary tract infections, respiratory tract infections and skin and soft tissue infection. METHOD: We used a multi-faceted process involving a literature review, consensus meeting [nominal group technique involving general practitioners (GPs) and specialists in geriatric medicine and clinical microbiology], focus groups (care home staff and resident family members) and interviews (GPs), alongside continual iterative internal review and analysis within the research team. RESULTS: Six publications were identified in the literature which met inclusion criteria. These were used to update the algorithm which was presented to a consensus meeting (four participants all with a medical background) which discussed and agreed to inclusion of signs and symptoms, and the algorithm format. Focus groups and interview participants could see the value in the algorithm, and staff often reported that it reflected their usual practice. There were also interesting contrasts between evidence and usual practice informed by experience. Through continual iterative review and analysis, the final algorithm was finally presented in a format which described management of the three infections in terms of initial assessment of the resident, observation of the resident and action by the care home staff. CONCLUSIONS: This study has resulted in an updated algorithm targeting key infections in care home residents which should be considered for implementation into everyday practice.

Communicating biopsy results from breast screening assessment: current practice in English breast screening centres and staff perspectives of telephoning results.

OBJECTIVE: To record how breast screening centres in England deliver all biopsy results (cancer/non-cancer) from the breast assessment visit. DESIGN: Online survey of 63 of 79 breast screening centres in England from all regions (East Midlands, East of England, London, North East Yorkshire & Humber, North West, South East, South West, West Midlands). The survey contained quantitative measures of frequency for telephoning biopsy results (routinely, occasionally or never) and optional qualitative free-text responses. Surveys were completed by a staff member from each centre. RESULTS: There were no regional trends in the use of telephone results services, (X² (14, n=63)=11.55, p=0.64), Centres who telephoned results routinely did not deliver results sooner than centres who deliver results in-person (X² (16, n=63)=12.76, p=0.69).When delivering cancer results, 76.2% of centres never telephone results and 23.8% of centres occasionally telephone results. No centres reported delivering cancer results routinely by telephone. Qualitative content analysis suggests that cancer results are only telephoned at the patient request and under exceptional circumstances.When delivering non-cancer results, 12.7% of centres never telephoned results, 38.1% occasionally telephoned results and 49.2% routinely telephoned results. Qualitative content analysis revealed different processes for delivering telephone results, including patient choice and scheduling an in-person results appointment for all women attending breast assessment, then ringing non-cancer results unexpectedly ahead of this prebooked appointment. CONCLUSIONS: In the National Health Service Breast Screening Programme, breast assessment results that are cancer are routinely delivered in-person. However, non-cancer breast assessment results are often routinely delivered by telephone, despite breast screening policy recommendations. More research is needed to understand the impact of telephoning results on women attending breast assessment, particularly women who receive a non-cancer result. Future research should also consider how women themselves might prefer to receive their results.

Facet joint injections for people with persistent non-specific low back pain (Facet Injection Study): a feasibility study for a randomised controlled trial.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. OBJECTIVES: To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. DESIGN: The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. SETTING: Five NHS acute trusts in England. PARTICIPANTS: Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with 'best usual care' (BUC) or BUC alone. INTERVENTIONS: All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. MAIN OUTCOME MEASURES: Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. RESULTS: Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. LIMITATIONS: Poor recruitment was a limiting factor. CONCLUSIONS: This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain. FUTURE WORK: Further work is needed to test recruitment from alternative clinical situations. TRIAL REGISTRATION: EudraCT 2014-000682-50 and Current Controlled Trials ISRCTN93184143. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 30. See the NIHR Journals Library website for further project information.

Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial.

BACKGROUND: Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. METHODS: We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277. FINDINGS: Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI -0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI -0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group. INTERPRETATION: This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required. FUNDING: National Institute for Health Research Health Technology Assessment.