Sally Hopewell’s research while affiliated with University of Oxford and other places

Background People post-hip fracture have reported experiences of fragmented care and poor discharge planning, therefore improvements in patient flow are required. This study reports the challenges people face during the discharge process and offers potential solutions for improving the transition from hospital to home from the perspectives of patients, carers, and health professionals. Methods This was a qualitative study embedded within a multi-centre, feasibility randomised controlled trial (HIP HELPER). We undertook semi-structured interviews with 10 patient-carer dyads (10 people with hip fracture; 10 unpaid carers) and eight health professionals (four physiotherapists, two occupational therapists, one nurse and one physiotherapy researcher) between November 2021 and March 2022. Data were analysed using the principles of Framework Analysis. Results Participants identified challenges in the transition from hospital to home post-hip fracture surgery: ineffective communication, disjointed systems, untimely services and ‘ it’s more than just the hip ’. Possible solutions and insights to facilitate this transition included the need for reassurance, collaborative planning, and individualisation. Conclusion The transition from hospital to home following hip fracture surgery can be a challenging experience for patients, and for friends and family who support them as carers, making them feel vulnerable, frustrated and uncertain. Enabling a coordinated, collaborative approach to discharge planning and early recovery provision is considered a positive approach to improving NHS care. Trial registration ISRCTN13270387. Registered 29th October 2020.

Introduction An important mechanism of research waste is inadequate incorporation of, and references to, previous relevant research. Identifying references for a research manuscript can be challenging, in part due to the exponential rise in potentially relevant literature to consider. For large research projects, such as developing or updating reporting guidelines, it may be helpful to construct a supportive topic‐specific bibliographic database. Methods In support of updating the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the CONsolidated Standards Of Reporting Trials (CONSORT) 2010, we developed the SPIRIT‐CONSORT Evidence Bibliographic database (SCEBdb): a freely available topic‐specific bibliographic database of publications providing an evidence foundation for the updates. We searched multiple sources of potential publications and tagged included ones with database‐specific keywords. For context, we also formulated 10 core considerations for constructing topic‐specific bibliographic databases and identified and described 5 illustrative other databases. Results As of April 2024, the SCEBdb included 846 publications. The database proved useful as a supplementary information source for our scoping review of published comments on SPIRIT 2013 and CONSORT 2010, for a supplementary Delphi process, and in the writing phase of the guidance documents. We expect that the database will be useful for future projects within the fields of clinical research methodology, bias, evidence synthesis, and randomized trials. Conclusion The methods involved in constructing the SCEBdb, and our suggested core considerations for topic‐specific bibliographic databases, could be helpful for researchers reflecting on whether, and how, to develop a topic‐specific bibliographic database.

Objective The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder. Design Multicentre, randomised feasibility trial, with embedded qualitative study. Setting Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services. Participants Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder. Interventions Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later. Primary feasibility objectives (1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months. Results Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%. Conclusion This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment. Trial registration number ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

Objectives To evaluate the efficacy of pharmacological interventions for treating early-stage, pain predominant, adhesive capsulitis, also known as frozen shoulder. Methods We performed a systematic review in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Searches were conducted on MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials on 24 February 2022. Outcomes were shoulder pain, shoulder function and range of movement. Synthesis involved both qualitative analysis for all studies and pairwise meta-analyses followed by a network meta-analysis for randomized controlled trials (RCTs). Results A total of 3252 articles were found, of which 31 met inclusion criteria, and 22 of these were RCTs. IA injection of CS (8 RCTs, 340 participants) and IA injection of platelet-rich plasma (PRP) (3 RCTs, 177 participants) showed benefit at 12 weeks compared with physical therapy in terms of shoulder pain and function, while oral NSAIDs (2 RCTs, 44 participants) and IA injection of hyaluronate (2 RCTs, 42 participants) did not show a benefit. Only IA PRP showed benefit over physical therapy for shoulder range of movement. Conclusion These results shows that IA CS and IA PRP injections are beneficial for early-stage frozen shoulder. These findings should be appraised with care considering the risk of bias, heterogeneity and inconsistency of the included studies. We believe that research focused on early interventions for frozen shoulder could improve patient outcomes and lead to cost-savings derived from avoiding long-term disability. Further well-designed studies comparing with standardized physical therapy or placebo are required to improve evidence to guide management.

Objectives To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Design Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study. Setting National Health Service (NHS) providers in five English hospitals. Participants Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers. Intervention Usual care: usual NHS care. Experimental: usual NHS care plus a caregiver–patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions. Randomisation and blinding Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding. Main outcome measures Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals. Results 102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable. Conclusions The HIP HELPER programme was acceptable to patient–caregiver dyads and health professionals. The COVID-19 pandemic impacting on site’s ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT. Trial registration number ISRCTN13270387 .