The impact of reduced routine community mental healthcare on people from minority ethnic groups during the COVID-19 pandemic: qualitative study of stakeholder perspectives.

BACKGROUND: Enduring ethnic inequalities exist in mental healthcare. The COVID-19 pandemic has widened these. AIMS: To explore stakeholder perspectives on how the COVID-19 pandemic has increased ethnic inequalities in mental healthcare. METHOD: A qualitative interview study of four areas in England with 34 patients, 15 carers and 39 mental health professionals from National Health Service (NHS) and community organisations (July 2021 to July 2022). Framework analysis was used to develop a logic model of inter-relationships between pre-pandemic barriers and COVID-19 impacts. RESULTS: Impacts were largely similar across sites, with some small variations (e.g. positive service impacts of higher ethnic diversity in area 2). Pre-pandemic barriers at individual level included mistrust and thus avoidance of services and at a service level included the dominance of a monocultural model, leading to poor communication, disengagement and alienation. During the pandemic remote service delivery, closure of community organisations and media scapegoating exacerbated existing barriers by worsening alienation and communication barriers, fuelling prejudice and division, and increasing mistrust in services. Some minority ethnic patients reported positive developments, experiencing empowerment through self-determination and creative activities. CONCLUSIONS: During the COVID-19 pandemic some patients showed resilience and developed adaptations that could be nurtured by services. However, there has been a reduction in the availability of group-specific NHS and third-sector services in the community, exacerbating pre-existing barriers. As these developments are likely to have long-term consequences for minority ethnic groups' engagement with mental healthcare, they need to be addressed as a priority by the NHS and its partners.

Does pain self-efficacy predict, moderate or mediate outcomes in people with chronic headache; an exploratory analysis of the CHESS trial.

BACKGROUND: Chronic headache disorders are disabling. The CHESS trial studied the effects of a short non-pharmacological intervention of education with self-management support for people affected by migraine and/or tension type headache for at least 15 days per month for at least three months. There were no statistically significant effects on the Headache Impact Test-6 (HIT-6) at 12-months. However, we observed improvement in pain self-efficacy questionnaire (PSEQ) and short-term HIT-6. We explored the impact of the CHESS intervention on PSEQ, and subsequently, on the HIT-6 and chronic headache quality of life questionnaire (CH-QLQ) at four, eighth and 12 months. METHODS: We included all 736 participants from the CHESS trial. We used simple linear regression models to explore the change of HIT-6 and CH-QLQ with treatment and PSEQ at baseline (predictor analysis), and the interaction between treatment and baseline PSEQ (moderator analysis). We considered the change of PSEQ from baseline to four months as a mediator in the mediation analysis. RESULTS: Baseline PSEQ neither predicted nor moderated outcomes. The prediction effect on change of HIT-6 from baseline to 12 months was 0.01 (95% CI, -0.03 to 0.04) and the interaction (moderation) effect was -0.07 (95% CI, -0.15 to 0.002). However, the change of PSEQ from baseline to 4-month mediated the HIT-6 (baseline to 8-, and 12-month) and all components of CH-QLQ (baseline to 8-, and 12-month). The CHESS intervention improved the mediated variable, PSEQ, by 2.34 (95% CI, 0.484 to 4.187) units and this corresponds to an increase of 0.21 (95% CI, 0.03 to 0.45) units in HIT-6 at 12-months. The largest mediated effect was observed on the CH-QLQ Emotional Function, an increase of 1.12 (95% CI, 0.22 to 2.20). CONCLUSIONS: PSEQ was not an effective predictor of outcome. However, change of short-term PSEQ mediated all outcomes, albeit minimally. Future behavioural therapy for chronic headache may need to consider how to achieve larger, and more sustained increases level of self-efficacy than that achieved within the CHESS trial. TRIAL REGISTRATION: ISRCTN79708100.

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial.

Importance: Opioid use for chronic nonmalignant pain can be harmful. Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration: isrctn.org Identifier: ISRCTN49470934.

To Trial or Not to Trial Before Spinal Cord Stimulation for Chronic Neuropathic Pain: The Patients' View From the TRIAL-STIM Randomized Controlled Trial.

Objectives Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL-STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL-STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not. Materials and Methods We interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow-up). Interviews were undertaken by telephone and audio-recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one-stage (no screening trial) versus two-stage (screening trial) implant procedure on a five-point Likert scale, before and after implantation. Results Emergent themes favoured the option for a one-stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having "loose wires" in the two-stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one-stage procedure without a screening trial. Conclusions Our findings indicate an overwhelming preference among participants for a one-stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL-STIM RCT results.

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting. METHODS: This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions. DISCUSSION: The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH. TRIAL REGISTRATION: ISRCTN no. 10608766, prospectively registered on 18th March 2019.

Development of an education and self-management intervention for chronic headache - CHESS trial (Chronic Headache Education and Self-management Study).

BACKGROUND: Self-management interventions are well recognised and widely used in chronic conditions. Their application to chronic headaches has been limited and generally of low quality. We describe here our process for developing an evidence based, and theory driven, education and self-management intervention for those living with chronic headache. METHODS: Our intervention was designed using several core information sources; the results of three systematic reviews, qualitative material from those living with chronic headaches, our knowledge from existing self-management interventions; and finally collaborative input from a multidisciplinary team of clinicians, academics, patients, and charity partners. We manualised the intervention and associated training as a package for use in a feasibility study. We made adaptations for its use in a randomised controlled trial. RESULTS: We piloted the intervention in four groups with a total of 18 participants. Qualitative feedback from 12 participants and five facilitators allowed the intervention to be refined for the main randomised controlled trial. Some of the key changes included shortening of the overall intervention, changes to the originally planned facilitators and spreading the facilitator training over three days rather than two. We are now testing the final revised intervention in a randomised controlled trial of its clinical and cost effectiveness. The group component of the intervention is delivered over two days with the first day focused on living, understanding and dealing with chronic headaches and the second day exploring how to adapt and take control of one's life with chronic headaches. CONCLUSION: Our pilot work indicates that our intervention is feasible to deliver, and with the relevant changes would be acceptable for use with this population. Our randomised control trial is ongoing. We anticipate publishing final results in 2021. TRIAL REGISTRATION: ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100.

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.

Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.

BACKGROUND: Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments. METHODS: This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into "satisfaction" (very satisfied or somewhat satisfied) and "non-satisfaction" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied). RESULTS: We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%. CONCLUSION: We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46035546 registered on 11/02/10.

Patient experiences and desires for recovery after ankle fracture surgery.

OBJECTIVE: This study investigates patients' experiences of commencing weight-bearing after ankle fracture surgery and their recovery priorities to inform a new rehabilitation intervention. METHODS: Embedded within the Weight bearing in Ankle Fractures (WAX) trial, this qualitative study conducted semi-structured interviews with patients following ankle fracture surgery. The Behaviour Change Wheel (BCW) framework guided the interview questions to ensure comprehensive domain coverage. A purposive, maximum variation sampling strategy was used for participant selection. Data analysis employed a combined deductive and inductive approach. RESULTS: A total of 29 patients were interviewed, revealing five key themes: understanding the recovery journey, navigating the healthcare system, understanding personal physical capabilities, building confidence for weight-bearing, and resuming daily activities. Themes emphasised the variability in healthcare access, the impact of non-weight-bearing on independence, and the role of self-efficacy in recovery. CONCLUSIONS: The study highlighted the diversity in patient experiences and recovery challenges post-ankle fracture surgery. Patients' recovery was influenced by access to consistent healthcare advice, self-efficacy, and the physical and psychological impact of non-weight-bearing. The findings suggest a need for tailored, patient-centred rehabilitation interventions that consider individual recovery trajectories and promote self-management. These insights provide a foundational understanding for developing interventions that more effectively address patient priorities and barriers to recovery.

Effectiveness of behavior change in rehabilitation interventions to improve functional recovery after lower limb fracture: a systematic review.

Ankle fractures are common injuries that can significantly impact mobility and quality of life. Rehabilitation following ankle fracture treatment is crucial for recovery, yet adherence to regimens remains a challenge. Behaviour Change Techniques (BCTs) have been suggested to improve adherence, but their effectiveness in ankle fracture rehabilitation is not well established. This review aimed to evaluate the effectiveness of BCTs in the rehabilitation of ankle fracture patients. We conducted a comprehensive search across multiple databases, including MEDLINE and EMBASE, focusing on Randomised Controlled Trials (RCTs) that incorporated BCTs into rehabilitation interventions. The effectiveness of BCTs on patient-reported outcomes (PROMs), quality of life, and adverse events was analysed. Nine RCTs met the inclusion criteria, encompassing a range of interventions that employed BCTs, most commonly including goal setting and instruction on how to perform behaviours, specifically physiotherapy exercises. The review found limited evidence supporting their effectiveness in improving PROMs. Only one study showed a significant positive effect, but it was deemed at high risk of bias. The lack of integration of behavioural theory in the design of rehabilitation interventions and the varied nature of the BCTs employed across studies may contribute to these findings. The use of BCTs in ankle fracture rehabilitation is prevalent, but this review highlights a significant gap their role of enhancing patient outcomes. Future research should incorporate a theory-based approach to intervention design, utilising a broader range of BCTs, to fully evaluate their potential in improving rehabilitation adherence and outcomes following ankle fracture .

Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial.

BACKGROUND: The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic. METHODS: Restrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees. CONCLUSIONS: We describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care. TRIAL REGISTRATION: ISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

OBJECTIVE: To evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition (long covid). DESIGN: Pragmatic, multicentre, parallel group, superiority randomised controlled trial. SETTING: England and Wales, with home based interventions delivered remotely online from a single trial hub. PARTICIPANTS: 585 adults (26-86 years) discharged from NHS hospitals at least three months previously after covid-19 and with ongoing physical and/or mental health sequelae (post-covid-19 condition), randomised (1:1.03) to receive the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) intervention (n=298) or usual care (n=287). INTERVENTIONS: Best practice usual care was a single online session of advice and support with a trained practitioner. The REGAIN intervention was delivered online over eight weeks and consisted of weekly home based, live, supervised, group exercise and psychological support sessions. MAIN OUTCOME MEASURES: The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months. Secondary outcomes, measured at three, six, and 12 months, included PROMIS subscores (depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities, and cognitive function), severity of post-traumatic stress disorder, general health, and adverse events. RESULTS: Between January 2021 and July 2022, 39 697 people were invited to take part in the study and 725 were contacted and eligible. 585 participants were randomised. Mean age was 56 (standard deviation (SD) 12) years, 52% were female participants, mean health related quality of life PROMIS-PROPr score was 0.20 (SD 0.17), and mean time from hospital discharge was 323 (SD 144) days. Compared with usual care, the REGAIN intervention led to improvements in health related quality of life (adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02) at three months, driven predominantly by greater improvements in the PROMIS subscores for depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01). Effects were sustained at 12 months (0.03 (0.01 to 0.06), P=0.02). Of 21 serious adverse events, only one was possibly related to the REGAIN intervention. In the intervention group, 141 (47%) participants fully adhered to the programme, 117 (39%) partially adhered, and 40 (13%) did not receive the intervention. CONCLUSIONS: In adults with post-covid-19 condition, an online, home based, supervised, group physical and mental health rehabilitation programme was clinically effective at improving health related quality of life at three and 12 months compared with usual care. TRIAL REGISTRATION: ISRCTN registry ISRCTN11466448.

Development of a complex exercise rehabilitation intervention for people with pulmonary hypertension: the supervised pulmonary hypertension exercise rehabilitation (SPHERe) trial.

BACKGROUND: People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH. METHODS: Development was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic 'lockdowns'. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021. DISCUSSION: The final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support 'coaching' sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial. TRIAL REGISTRATION NUMBER: ISCRTN10608766.

'It was a joint plan we worked out together'. How the I-WOTCH programme enabled people with chronic non-malignant pain to taper their opioids: a process evaluation.

BACKGROUND: The Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial found that a group-based educational intervention to support people using strong opioids for chronic non-malignant pain helped a significant proportion of people to stop or decrease opioid use with no increase in pain-related disability. We report a linked process evaluation of the group-based intervention evaluated in comparison to a usual-care control group that received a self-help booklet and relaxation CD. METHODS: We interviewed 18 intervention facilitators, and 20 intervention and 20 control participants who had chronic non-malignant pain and were recruited from general (family) practices in the UK. Quantitative data included change mechanism questions on the trial questionnaires which explored motivation, expectations and self-efficacy. Fidelity was assessed by listening to a sample of audio-recorded group sessions and nurse consultations. Quantitative and qualitative data were integrated using 'follow a thread' and a mixed-methods matrix. FINDINGS: Four overarching themes emerged: (1) the right time to taper, (2) the backdrop of a life with chronic pain, (3) needing support and (4) the benefits of being in a group. Delivery fidelity was good, adherence (83%) and competence (79%) across a range of intervention groups. Staff delivering the intervention found three typical responses to the intervention: resistance, open to trying and feeling it was not the right time. The group experience was important to those in the intervention arm. It provided people with a forum in which to learn about the current thinking about opioid usage and its effects. It also gave them examples of how feasible or personally relevant coming off opioids might be. CONCLUSION: The process evaluation data showed that the I-WOTCH intervention was well delivered, well received and useful for most interviewees. Being 'the right time' to taper and having support throughout tapering, emerged as important factors within the context of living with chronic pain. TRIAL REGISTRATION NUMBER: ISRCTN49470934.

Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial.

Background: Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge. Methods: Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions. Results: The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos. Conclusions: The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.

Long-COVID has many debilitating symptoms, such as breathlessness, muscle weakness and fatigue, which significantly affect peoples' physical and mental health and quality of life. Rehabilitation programmes can help people improve their quality of life in other medical conditions with similar symptoms. We developed a programme of physical and mental health rehabilitation, delivered online, specifically to support people with ongoing long-COVID symptoms more than three months after hospital discharge. The programme was developed by people with long-COVID along with clinicians and researchers. The programme described in this article is now being tested in a large research trial to see if it can help people with long-COVID.

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.

Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study.

BACKGROUND: There is a dearth of research to support the treatment of people with postural tachycardia syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS. METHODS: The intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the 'three co's framework' of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the UK. Eighteen patient and public involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement. RESULTS: The final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals' perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important. CONCLUSIONS: An innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third-sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS. TRIAL REGISTRATION: ISRCTN45323485 was registered on April 7, 2020.

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.

Development and testing of an opioid tapering self-management intervention for chronic pain: I-WOTCH.

OBJECTIVES: To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial. DESIGN: The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described. SETTING: The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development-to develop an opioid tapering App. PARTICIPANTS: The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month. OUTCOMES: A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use. INTERVENTIONS AND RESULTS: Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a 'trade-off to fill the deficit of the effect of the drug'. The final I-WOTCH intervention consists of an 8-10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK. CONCLUSIONS: We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial. TRIAL REGISTRATION NUMBER: ISRCTN49470934.