Julie Bruce

Background Pulmonary Hypertension (PH) is a debilitating condition which can lead to avoidance of physical activity and reduced health-related quality of life (HRQoL). The Supervised Pulmonary Hypertension Exercise rehabilitation (SPHERe) multi-centre RCT found that remotely supervised online group exercise-based rehabilitation was safe and well tolerated, but not superior to a single one-to-one advice session for improving walking distance and HRQoL over 12 months. An embedded qualitative study aimed to explore participant and practitioner experiences of the trial and interventions. Design Qualitative process evaluation utilising semi-structured interviews. The framework method was used to analyse findings. Setting England and Scotland, UK. Participants Adults with PH living in the community. Results Twenty intervention participants, 20 usual care participants, and five intervention practitioners were interviewed. Barriers to participation in the SPHERe intervention group included finding time and being ill, whilst the dynamics of being in an online group were seen both as positive and negative. Enablers for participation included the support that came from a shared experience and a sense of belonging. Conclusion Despite a lack of clinical effectiveness, the SPHERe intervention was mostly well received by participants and practitioners. The main barrier was finding time to exercise. The main enabler was being in a group and the support this provided. Online group interventions should be considered important for future research and service models, whilst also appreciating the challenges associated with this mode of delivery.

Background Ankle fracture fixation surgery may be performed with or without the use of a tourniquet. Surgeons who use a tourniquet report reduced intraoperative bleeding, which improves the visualisation of anatomical structures. This may facilitate more accurate fracture fixation and restoration of the anatomical configuration of the ankle joint, potentially leading to improved functional outcomes. An additional proposed benefit of tourniquet use is reduced operative time. In contrast, surgeons who choose not to use a tourniquet report concerns that it may exacerbate postoperative pain and increase the risk of venous thromboembolism, surgical site infection and other complications. However, existing clinical trials are limited by small sample sizes and high risk of bias, preventing the ability to draw robust conclusions. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the potential benefits and risks of tourniquet use in ankle fracture fixation surgery. Methods This study comprises a two-centre, participant-blinded and surgeon-blinded parallel-arm RCT and an integrated qualitative interview study. A computer-generated randomisation service will allocate up to 50 patients to undergo ankle fracture fixation surgery either with or without the use of a tourniquet. Participants will be followed up for 3 months postoperatively. Primary outcomes include recruitment and retention rates, data completeness, success of blinding and adherence to allocated intervention. Secondary outcomes include postoperative pain, quality of the surgical field, intraoperative blood loss, blood transfusions, procedure duration, skin assessment, awareness of tourniquet use, health-related quality of life (EuroQol-5D-5L), Olerud-Molander Ankle Score and intraoperative and postoperative complications. The integrated qualitative study will consist of semistructured interviews with up to 12 patients and 12 trauma and orthopaedic surgeons (~24 interviews). Interviews will explore perspectives on the feasibility trial, identify factors associated with unblinding and examine barriers and potential solutions to the design and delivery of a future definitive trial. Interviews will be analysed using inductive thematic analysis. Ethics and dissemination National Research Ethics Committee (East of England-Essex) approved this study on the 8 May 2025 (REC 25/EE/0051). The results will be disseminated via peer-reviewed publication. Trial registration number ISRCTN91783787.

Background/aims This paper describes the development (content, theory, and construction) of a patient-centered, structured, individually tailored, multicomponent intervention (the iRehab intervention) to promote rehabilitation and recovery after critical illness. Methods The intervention was informed by the MRC framework for complex interventions and underpinned by existing literature and psychological theories. Key stakeholders included patients who had been in intensive care and multidisciplinary staff with experience in providing healthcare and undertaking research. Results The final intervention includes four core components: 1. weekly discussion and guidance regarding symptom management; 2. targeted exercise and physical activity; 3. support for psychological well-being; 4. peer support and information provision. These are packaged as a program to support rehabilitation and recovery after ICU discharge. Programme duration: Six weeks. Format: Weekly one-to-one remote needs assessment to identify individual participant symptoms and provide management plans, exercises, and strategies to best support recovery. Participants are encouraged to attend weekly group-based remote exercise sessions and group-based remote support sessions (iRehab Café). Mode of delivery: Remote delivery facilitated by online platforms such as Microsoft Teams or Zoom supported with video platform BEAM©, and delivery can also be supported by telephone. The preferred mode of remote delivery is agreed with the participant, and potential barriers to implementation are considered. Manuals are posted to all participants to support intervention delivery. Discussion/conclusion This paper reports the content, theory and construction of the iRehab intervention. The iRehab intervention is currently being tested in a multicenter RCT (iRehab ISRCTN11266403), and the details reported in this paper will help with understanding of the intervention, interpretation of the findings, and replication of the intervention. Detailed intervention manuals will be available upon the completion of the trial.

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

Background The consequences of critical illness can be substantial and multifactorial, encompassing physical deconditioning, mental health impairments, fatigue, and declines in health-related quality of life. We hypothesise that for people discharged after intensive care unit (ICU) for a critical illness, a six-week remote multicomponent rehabilitation intervention improves health-related quality of life, physical function, fatigue, mood, and other health-related outcomes after eight weeks, compared to standard care. Methods This is a pragmatic, randomised controlled, open-label, assessor blind, multicentre, clinical and cost effectiveness trial with internal pilot and embedded process evaluation. Recruitment will take place in NHS hospitals across the UK. Adults (n=428: control n= 197; intervention: n=231) within 12 weeks of discharge from hospital following an ICU admission for critical illness, requiring mechanical ventilation ≥48hours will be recruited. The intervention is a six week multicomponent, structured, rehabilitation programme, delivered remotely by a trained intervention team. The intervention includes four components: weekly symptom management; targeted exercise; psychological support, and peer support and information. The control group will receive standard NHS care. The primary outcome is Health-related quality of life (HRQoL) at eight weeks post-randomisation measured using the EQ-5D-5L. Secondary outcomes are: HRQoL (six months), physical function, fatigue, illness perceptions anxiety and depression, healthcare resource use at eight weeks and six months and intervention acceptability. Conclusions This trial will test a centrally delivered mulitcomponent rehabilitation intervention for survivors of critical illness, irrespective of geographic location or critical illness diagnosis. Trial registration The trial is registered (04.07.2022) with the International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN11266403 https://doi.org/10.1186/ISRCTN11266403

Background/aims This paper describes the development (content, theory, and construction) of a patient-centered, structured, individually tailored, multicomponent intervention (the iRehab intervention) to promote rehabilitation and recovery after critical illness. Methods The intervention was informed by the MRC framework for complex interventions and underpinned by existing literature and psychological theories. Key stakeholders included patients who had been in intensive care and multidisciplinary staff with experience in providing healthcare and undertaking research. Results The final intervention includes four core components: 1. weekly discussion and guidance regarding symptom management; 2. targeted exercise and physical activity; 3. support for psychological well-being; 4. peer support and information provision. These are packaged as a program to support rehabilitation and recovery after ICU discharge. Programme duration: Six weeks. Format: Weekly one-to-one remote needs assessment to identify individual participant symptoms and provide management plans, exercises, and strategies to best support recovery. Participants are encouraged to attend weekly group-based remote exercise sessions and group-based remote support sessions (iRehab Café). Mode of delivery: Remote delivery facilitated by online platforms such as Microsoft Teams or Zoom supported with video platform BEAM©, and delivery can also be supported by telephone. The preferred mode of remote delivery is agreed with the participant, and potential barriers to implementation are considered. Manuals are posted to all participants to support intervention delivery. Discussion/conclusion This paper reports the content, theory and construction of the iRehab intervention. The iRehab intervention is currently being tested in a multicenter RCT (iRehab ISRCTN11266403), and the details reported in this paper will help with understanding of the intervention, interpretation of the findings, and replication of the intervention. Detailed intervention manuals will be available upon the completion of the trial.

Background The consequences of critical illness can be substantial and multifactorial, encompassing physical deconditioning, mental health impairments, fatigue, and declines in health-related quality of life. We hypothesise that for people discharged after intensive care unit (ICU) for a critical illness, a six-week remote multicomponent rehabilitation intervention improves health-related quality of life, physical function, fatigue, mood, and other health-related outcomes after eight weeks, compared to standard care. Methods This is a pragmatic, randomised controlled, open-label, assessor blind, multicentre, clinical and cost effectiveness trial with internal pilot and embedded process evaluation. Recruitment will take place in NHS hospitals across the UK. Adults (n=428: control n= 197; intervention: n=231) within 12 weeks of discharge from hospital following an ICU admission for critical illness, requiring mechanical ventilation ≥48hours will be recruited. The intervention is a six week multicomponent, structured, rehabilitation programme, delivered remotely by a trained intervention team. The intervention includes four components: weekly symptom management; targeted exercise; psychological support, and peer support and information. The control group will receive standard NHS care. The primary outcome is Health-related quality of life (HRQoL) at eight weeks post-randomisation measured using the EQ-5D-5L. Secondary outcomes are: HRQoL (six months), physical function, fatigue, anxiety and depression, healthcare resource use at eight weeks and six months and intervention acceptability. Conclusions This trial will test a centrally delivered mulitcomponent rehabilitation intervention for survivors of critical illness, irrespective of geographic location or critical illness diagnosis. Trial registration The trial is registered (04.07.2022) with the International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN11266403 https://doi.org/10.1186/ISRCTN11266403

Objective: Intra-articular corticosteroid injections are commonly used in the management of foot and ankle OA. Although current clinical guidelines advocate the judicious use of corticosteroid injection as an adjunct therapy, none of these recommendations are specific to the foot and ankle. Therefore, the aim of this review is to examine the effectiveness of intra-articular corticosteroid injections in people with foot or ankle OA. Methods: Four databases (Cumulative Index to Nursing and Allied Health Literature [CINAHL], MEDLINE, EMBASE and CENTRAL) and one clinical trial register (International Clinical Trials Registry Platform [ICTRP]) were searched from inception to June 2024 for randomized control trials (RCTs) and quasi-RCTs evaluating corticosteroid injection in the treatment of foot or ankle OA on pre-specified outcomes: pain, function, quality of life, safety (adverse events) and/or cost-effectiveness. Two independent reviewers conducted record screening, data extraction (Cochrane data extraction tool) and assessment of methodological quality (Cochrane Risk of Bias tool [RoB 2.0]). Results: From 1711 citations, two RCTs (57 participants, 49% males) were identified. There were no differences in pain or function over 8 weeks after a single injection of intra-articular corticosteroid compared with prolotherapy for treatment of first metatarsal joint OA. Pain and function significantly improved in people having three corticosteroid injections combined with hyaluronic acid compared with corticosteroid injections alone for treatment of post-traumatic subtalar OA. Methodological quality was graded as some concerns in both trials. Conclusion: There is insufficient evidence to guide the use of intra-articular corticosteroid injections for OA of the foot or ankle. Future robust research is needed to provide reliable evidence for this commonly performed treatment.

Objectives The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS). Design Feasibility RCT. Setting Two secondary care centres. Participants Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy. Interventions Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the ‘postural tachycardia syndrome exercise’ (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike. Outcomes The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability. Results 209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable. Conclusions The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service. Trial registration number ISRCTN45323485.

Background: This qualitative evaluation was embedded in the Rehabilitation Exercise and psycholoGical support After COVID-19 InfectioN (REGAIN) study, a randomised controlled trial (RCT) for those with post-COVID-19 condition (‘long COVID’) after hospital admission for COVID-19, comparing weekly home-based, live online supervised group exercise and psychological support sessions with ‘best practice usual care’ (a single session of advice).Objective: To increase our understanding of how and why the REGAIN programme might have worked and what helped or hindered this intervention.Design: A qualitative evaluation which utilised interviews with participants and practitioners delivering the intervention. Framework and thematic analysis were used to analyse the findings.Setting: England and Wales, UK.Participants: Adults discharged from National Health Service (NHS) hospitals at least 3 months previously after COVID-19, with ongoing physical and/or mental health sequelae.Results: Twenty intervention participants, 20 control participants and five practitioners were interviewed.The themes from the group support sessions were: (1) you are not alone; (2) sharing experiences and addressing worries; (3) gaining new perspectives; (4) hope for progression; (5) peer support and bonding; (6) integration of facilitation skills; (7) modified activity pacing and goal setting, and (8) giving participants structure. The themes from group exercise were: (1) monitoring and modification of the online exercise; (2) catering for differing abilities; (3) feeling safe and confident to exercise; (4) progression of fitness; (5) optimal timing in the recovery trajectory; (6) group effect; (7) initial apprehension about exercise group; (8) gauging exercise capabilities; (9) translating exercises into life; and (10) on-demand supplementary videos. The 1:1 consultation sessions revealed patients needed to tell their stories.Conclusion: Being listened to and being understood by someone ‘who got it’ was very important to people with post-COVID-19 condition. The group sessions of both exercise and psychological support were valued by participants, working together, and learning from each other in the face of a new disease within a global pandemic.