Chronic Headache Education and Self-Management Study (CHESS): a process evaluation.

BACKGROUND: The Chronic Headache Education and Self-Management Study (CHESS) multicentre randomised trial evaluated the impact a group education and self-management support intervention with a best usual care plus relaxation control for people living with chronic headache disorders (tension type headaches or chronic migraine, with or without medication overuse headache). Here we report the process evaluation exploring potential explanations for the lack of positive effects from the CHESS intervention. METHODS: The CHESS trial included 736 (380 intervention: 356 control) people across the Midlands and London UK. We used a mixed methods approach. Our extensive process evaluation looked at context, reach, recruitment, dose delivered, dose received, fidelity and experiences of participating in the trial, and included participants and trial staff. We also looked for evidence in our qualitative data to investigate whether the original causal assumptions underpinning the intervention were realised. RESULTS: The CHESS trial reached out to a large diverse population and recruited a representative sample. Few people with chronic tension type headaches without migraine were identified and recruited. The expected 'dose'of the intervention was delivered to participants and intervention fidelity was high. Attendance ("dose received") fell below expectation, although 261/380 (69%) received at least at least the pre-identified minimum dose. Intervention participants generally enjoyed being in the groups but there was little evidence to support the causal assumptions underpinning the intervention were realised. CONCLUSIONS: From a process evaluation perspective despite our extensive data collection and analysis, we do not have a clear understanding of why the trial outcome was negative as the intervention was delivered as planned. However, the lack of evidence that the intervention causal assumptions brought about the planned behaviour change may provide some insight. Our data suggests only modest changes in managing headache behaviours and some disparity in how participants engaged with components of the intervention within the timeframe of the study. Moving forwards, we need a better understanding of how those who live with chronic headache can be helped to manage this disabling condition more effectively over time. TRIAL REGISTRATION: ISRCTN79708100 .

What influences graduate medical students' beliefs of lower back pain? A mixed methods cross sectional study.

BACKGROUND: Low back pain (LBP) is a common condition with substantial associated disability and costs, best understood using a biopsychosocial approach. Research demonstrates that beliefs about LBP are important, with biomedical beliefs influencing practitioner's management and patient recovery. Beliefs about LBP can be inconsistent amongst healthcare and medical students. The aim of this study was to investigate graduate medical student's beliefs of LBP and what influences them. METHOD: A cross sectional mixed methods study of Phase 1 (first year) and Phase 3 (third and fourth year) current graduate medical students at the University of Warwick (MBChB) was conducted. Participants were recruited via voluntary response sampling. A survey investigated LBP beliefs, utilising the Back Beliefs Questionnaire (BBQ) and Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS). Qualitative data was collected on what influences beliefs about the causes and management of LBP, which was analysed descriptively using thematic analysis. RESULTS: Fifty-seven students completed the questionnaire (61% female), with a mean age of 27.2 years. Eighty two percent of participants reported a history of LBP. Median BBQ scores were 31.5 for phase 1 and 31 for phase 3, with median HC-PAIRS scores of 57 and 60 for phase 1 and phase 3 students respectively. Three main themes emerged from the qualitative data: Sources of influence, influence of personal experience and influence of medical education. Participants discussed single or multiple sources influencing their beliefs about the causes and management of LBP. Another main theme was the influence of experiencing LBP personally or through discussions with family, friends and patients. The final main theme described the influence of medical education, including lectures, seminars and clinical placements. CONCLUSIONS: The HC-PAIRS and BBQ scores suggest graduate medical students in this sample tended to have positive beliefs about the outcome of LBP and functional expectations of chronic LBP patients, consistent with other healthcare students. The findings from qualitative data suggest how medical students form beliefs about the causes and management of LBP is complex.

An intervention to increase physical activity in care home residents: results of a cluster-randomised, controlled feasibility trial (the REACH trial).

BACKGROUND: Care home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required. DESIGN AND SETTING: Cluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n = 5) or UC only (n = 7). PARTICIPANTS: Permanent residents aged ≥65 years. INTERVENTION: MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents. OBJECTIVES AND MEASUREMENTS: Feasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants' physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation. RESULTS: 300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was <75%; at 9 months, 65.6% of residents provided valid accelerometer data; two CHs fully, two partially and one failed to implement the intervention. There were no safety concerns. CONCLUSIONS: Recruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.

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.

Primary outcome measures used in interventional trials for ankle fractures: a systematic review.

BACKGROUND: Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture. METHODS: We performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type. RESULTS: The searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980's. CONCLUSION: This review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results.

Intra-articular facet joint injections for low back pain: a systematic review.

PURPOSE: Evidence supporting the use of therapeutic intra-articular facet joint injections for patients with suspected facet joint pain is sparse. A systematic review including a narrative synthesis was carried out to determine if intra-articular facet joint injections with active drug are more effective in reducing back pain and back pain-related disability than a sham procedure or a placebo/inactive injection. Secondly, to determine if intra-articular facet joint injections with active drug or placebo/inactive injection are more effective in reducing back pain and back pain-related disability than conservative treatment. METHODS: Medline, EMBASE, CINAHL, CENTRAL, Index to Chiropractic Literature and the Cochrane Central Register of Controlled Trials were searched from inception through April 2015. Data were screened and single extraction with independent verification and risk of bias assessment was performed. RESULTS: A total of 391 records were screened, and six trials were included. The trials included were small (range 18-109 participants) and overall in terms of pain and disability outcomes most were inconclusive. Only two of the trials report any significant between-group differences in pain (mean difference -1.0, 95% CI -2.0 to -0.1) and (p = 0.032) or disability (mean difference -3.0, 95% CI -6.2 to 0.2) and (p = 0.013) outcomes. CONCLUSIONS: The studies found here were clinically diverse and precluded any meta-analysis. A number of methodological issues were identified. The positive results, whilst interpreted with caution, do suggest that there is a need for further high-quality work in this area.

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.

Whole home exercise intervention for depression in older care home residents (the OPERA study): a process evaluation.

BACKGROUND: The 'Older People's Exercise intervention in Residential and nursing Accommodation' (OPERA) cluster randomised trial evaluated the impact of training for care home staff together with twice-weekly, physiotherapist-led exercise classes on depressive symptoms in care home residents, but found no effect. We report a process evaluation exploring potential explanations for the lack of effect. METHODS: The OPERA trial included over 1,000 residents in 78 care homes in the UK. We used a mixed methods approach including quantitative data collected from all homes. In eight case study homes, we carried out repeated periods of observation and interviews with residents, care staff and managers. At the end of the intervention, we held focus groups with OPERA research staff. We reported our first findings before the trial outcome was known. RESULTS: Homes showed large variations in activity at baseline and throughout the trial. Overall attendance rate at the group exercise sessions was low (50%). We considered two issues that might explain the negative outcome: whether the intervention changed the culture of the homes, and whether the residents engaged with the intervention. We found low levels of staff training, few home champions for the intervention and a culture that prioritised protecting residents from harm over encouraging activity. The trial team delivered 3,191 exercise groups but only 36% of participants attended at least 1 group per week and depressed residents attended significantly fewer groups than those who were not depressed. Residents were very frail and therefore most groups only included seated exercises. CONCLUSIONS: The intervention did not change the culture of the homes and, in the case study homes, activity levels did not change outside the exercise groups. Residents did not engage in the exercise groups at a sufficient level, and this was particularly true for those with depressive symptoms at baseline. The physical and mental frailty of care home residents may make it impossible to deliver a sufficiently intense exercise intervention to impact on depressive symptoms.

Surgeon views regarding the adoption of a novel surgical innovation into clinical practice: systematic review.

BACKGROUND: The haphazard adoption of new surgical technologies into practice has the potential to cause patient harm and there are many misconceptions in the decision-making behind the adoption of new innovations. The aim of this study was to synthesize factors affecting a surgeon's decision to adopt a novel surgical innovation into clinical practice. METHODS: A systematic literature search was performed to obtain all studies where surgeon views on the adoption of a novel surgical innovation into clinical practice have been collected. The databases screened were MEDLINE, Embase, Science Direct, Scopus, the Web of Science, and the Cochrane Library of Systematic Reviews (last accessed October 2022). Innovations covered multiple specialties, including cardiac, general, urology, and orthopaedics. The quality of the papers was assessed using a 10-question Critical Appraisal Skills Programme (CASP) tool for qualitative research. RESULTS: A total of 26 studies (including 1112 participants, of which 694 were surgeons) from nine countries satisfied the inclusion and exclusion criteria. Types of study included semi-structured interviews and focus groups, for example. Themes and sub-themes that emerged after a thematic synthesis were categorized using five causal factors (structural, organizational, patient-level, provider-level, and innovation-based). These themes were further split into facilitators and barriers. Key facilitators to adoption of an innovation include improved clinical outcomes, cost-effectiveness, and support from internal and external stakeholders. Barriers to adoption include lack of organizational support and views of senior surgeons. CONCLUSION: There are multiple complex factors that dynamically interact, affecting the adoption of a novel surgical innovation into clinical practice. There is a need to further investigate surgeon and other stakeholder views regarding the strength of clinical evidence required to support the widespread adoption of a surgical innovation into clinical practice.

The experiences of cardiac arrest survivors and their key supporters following cardiac arrest: A systematic review and meta-ethnography.

AIM: To review qualitative studies on the experience of sudden cardiac arrest survival from the perspective of both survivors and their key supporters, including family/close friends. METHODS: A seven-step meta-ethnography and synthesis of qualitative evidence was undertaken, informed by the Meta-Ethnography Reporting Guidelines (eMERGe). Four major databases were searched (Medline, EMBASE, CINAHL, PsycINFO; January 1995-January 2022, updated July 2023) for qualitative studies exploring survivors' and/or key supporters' experiences of cardiac arrest survival. The Critical Appraisal Skills Programme checklist and Grading of Recommendations Assessment, Development and Evaluation - Confidence in Evidence from Reviews of Qualitative Research (GRADE-CERQual) were applied to evaluate the overall confidence in research findings. Constructs were identified from each paper, informing theme and sub-theme development. RESULTS: From 15,917 unique titles/abstracts and 196 full-text articles, 32 met the inclusion criteria. Three themes captured the survivors' experiences: 1) Making sense of my cardiac arrest; 2) Learning to trust my body and mind; and 3) Re-evaluating my life. A further three themes reflected key supporters' experiences: 1) Emotional turmoil; 2) Becoming a carer: same person but different me; and 3) Engaging with a new and unknown world. However, limited data and some methodological weaknesses in included studies reduced confidence in several themes. The findings were conceived within the overarching concept of 'negotiating a new normal'. CONCLUSIONS: The enduring psychosocial and physical sequelae of cardiac arrest survival substantially impacts the lives of survivors and their key supporters, requiring negotiation of their 'new normality'. The need for sense-making, physical and psychological recovery, and the new roles for key supporters should be strong considerations in the development of future interventions.

A Qualitative Study of Patients' Lived Experiences of Free Tissue Transfer for Diabetic Foot Disease.

Background: Free tissue transfer (FTT) for reconstruction of diabetic foot disease (DFD) is an emerging field to preserve the lower limb within this patient group. The design of future quantitative research and clinical services in this area must consider the needs, expectations and concerns of patients. This qualitative study explores patient experiences of FTT for reconstruction of DFD. Methods: Semistructured interviews were conducted to explore patients' lived experiences of FTT for DFD. A purposive sampling strategy identified six patients who underwent FTT for recalcitrant DFD between September 2019 and December 2021 in a single center in the United Kingdom. Results: Three experiential themes emerged. Theme 1: "negative lived experiences of living with DFD" included frustration with the chronic management of nonhealing ulcers and fear regarding limb amputation. Theme 2: "surgery related concerns" included fears of reconstructive failure and subsequent amputation, as well as foot cosmesis and donor-site morbidity. Theme 3: "positive lived experiences following reconstruction" included the positive impact the reconstruction had on their overall life and diabetic control. All patients would repeat the process to obtain their current results. Conclusions: This qualitative study provides first-hand insight into the lived experience of FTT for DFD, exploring both the negative and positive experiences and reasons for these. We found that FTT for DFD can be positively life-changing for affected individuals.

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.

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.

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.

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.

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.

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.

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.

An evaluation of the measurement properties of the Olerud Molander Ankle Score in adults with an ankle fracture.

OBJECTIVES: The aim of this study is to evaluate the measurement properties of the Olerud Molander Ankle Score in adults with an ankle fracture. METHODS: Patients completed outcome measure questionnaires at baseline, six, 10- and 16-weeks postinjury as part of an ongoing clinical trial on ankle fracture rehabilitation. The internal consistency, convergent validity, structural validity and interpretability of the Olerud Molander Ankle Score was assessed. This was achieved through using the respective analysis methods of Cronbach's alpha, correlation coefficients, principal component analysis, evaluation of floor and ceiling scores and estimation of the minimally important change using anchor-based methods. RESULTS: The Olerud Molander Ankle Score showed adequate convergent validity against hypotheses set in relation to scores of comparator instruments. Principal component analysis demonstrated that the measure has two subscales: ankle function and ankle symptoms. The internal consistency of the measure and the ankle function subscale was sufficient, but inconclusive for the ankle symptoms subscale. There were no floor and ceiling effects present within the scores and the estimated minimally important change was 9.7 points. CONCLUSION: The Olerud Molander Ankle Score demonstrates sufficient measurement properties and is likely to be primarily measuring the construct of patient reported function following ankle fracture. Further research should evaluate the relevance of other domains to individuals recovering from and ankle fracture, such as social participation and psychological wellbeing. The development of a core outcome set would be advantageous to standardise outcome measurement collection in this area.

A systematic review of the methods and drugs used for performing suprascapular nerve block injections for the non-surgical management of chronic shoulder pain.

Suprascapular nerve block (SSNB) injections are growing in popularity as a treatment option for people with chronic shoulder pain. The optimal method of injection and aftercare is unknown. This review describes the current methods and drugs used for performing SSNB injections in the non-surgical management of adults with chronic shoulder pain in order to inform future research in this area. Systematic searches of CINAHL, MEDLINE (OVID), AMED, Embase databases and the Cochrane Library were undertaken from inception to June 2020. Data on the method and drugs used for injection and aftercare were extracted and summarised for areas of commonality and discrepancy. We included 53 studies in this review. In total, eight different injection methods were reported within the included studies. Indirect surface land-marked methods were the most common method reported in 21 studies. Direct surface land-marked methods were reported in 12 studies. Ultrasound-guided methods used alone were reported in 16 studies. Both fluoroscopy and computed tomography methods used alone were reported in one study each. Electromyography was used in combination with other injection methods in nine studies. Wide variation in the composition of the injectate was observed between studies. Local anaesthetic was used within injectate preparations in all studies. Local anaesthetic used alone was reported in 20 studies, combined with steroid in 29 studies and combined with various other components in 5 studies. Physiotherapy following injection was reported in 26 studies. Reported details of physiotherapy varied considerably. This review identified substantial variation in the methods and drugs used to perform SSNB injection in clinical trials. Current literature demonstrates a wide range of methods used for SSNB injection administration. Consensus research defining standardised practice for SSNB injection is now needed to guide future clinical practice and research.