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Celebrating 20 years of excellence with Doug Altman and welcoming the future.
Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.
OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after total hip replacement (THR) or total knee replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial. SETTING: National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged ≥18 years, undergoing a primary THR or TKR deemed 'moderately inactive' or 'inactive'. INTERVENTION: Participants received either six, 30 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION AND BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 and 12-month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental: 85 usual care). Mean age was 68.4 years (SD: 8.7), 63% were women, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at 6 or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution. TRIAL REGISTRATION NUMBER: ISRCTN29770908.
Intra-articular corticosteroid injections for osteoarthritis: A qualitative study of patients' and clinicians' experiences.
BACKGROUND: Osteoarthritis is a leading cause of joint pain and disability. Intra-articular corticosteroid injections (IACs) are often used in primary care once other recommended treatments have failed. Evidence shows that IACs provide short-term relief of osteoarthritis symptoms, yet little is known about patients' and primary care clinicians' experiences and beliefs about their use. We explored patients' and primary care clinicians' views about IACs, including the benefits, disadvantages, perceived risks of treatment, when they are used, and factors that affect decision-making. METHODS: We conducted individual interviews with patients and primary care clinicians and used inductive thematic analysis to investigate their views and experiences of intra-articular corticosteroid injections for osteoarthritis (IACs). FINDINGS: We interviewed 38 patients and 19 primary care clinicians. We identified 6 patient themes: variation in access; awareness of IACs; views of risk and trust; effectiveness of IACs; variation in onset and effect duration; and an alternative to undesirable treatments. In the interviews with clinicians, we identified an overarching theme of caution and competence, which included eight subthemes: confidence and (dis)comfort with practical procedures; risk of adverse outcomes; training; uncertainty about evidence and guidelines; technical uncertainties; IACs use on the osteoarthritis pathway; perceived benefits and impacts of IACs; and the possibility of placebo. CONCLUSION: Patients and clinicians valued IACs' potential to relieve symptoms and improve quality of life. Variability in patients' access to treatment appears related to clinicians' confidence in delivering injections and their concerns about the evidence base. Variation in dose frequency and timing reflect clinicians' uncertainty about current guidance. Despite variation in effectiveness patients preferred IACs to other forms of pain medication and to delay or avoid surgery. IACs were mostly used as an adjunct treatment before surgery was offered. These findings can inform further research into the effectiveness of IACs and improvements in information and guidance.
Applicability of Vfrac in men: a qualitative study of an osteoporotic vertebral fracture screening tool for use in older people with back pain
Summary: The Vfrac clinical screening tool was developed to help primary care healthcare practitioners decide if an older woman with back pain is at high risk of a vertebral fragility fracture (VFF) and requires a spinal radiograph to confirm diagnosis. The Vfrac tool developmental work was carried out in women because of the higher background prevalence of VFF. We now wish to assess Vfrac in men. Purpose: To understand and characterise pain symptoms of men with VFF, and to evaluate the wording of the Vfrac tool from men’s perspective, to establish if a gender specific version of the Vfrac tool was needed. Methods: Individual interviews were conducted with 15 men using an interview topic guide based on the original Vfrac topic guide with the addition of a ‘think aloud’ section to discuss the wording of the current questions within the Vfrac tool. Thematic analysis was conducted by two researchers. Results: Seven themes highlight that that physical measurements can be potentially upsetting for those being measured(‘Weighed, measured and found wanting’); that closed questions cannot capture the complexity of experience (There isn’t room on the paper; pain is dynamic, not static; Walking can make it better or worse; well, it depends on which chair); and that gendered roles are varied and dynamic (I try to do my share of domestic work; No more Do-it-yourself). Conclusions: This research has allowed the male perspective of osteoporosis to be heard and importantly identified that the Vfrac tool had no gender specific barriers.
Understanding what it is like to experience pain as you grow up: a poetic meta-ethnography.
A recent Lancet Commission raised concerns about the management of child and adolescent pain. We aimed to undertake a comprehensive review of qualitative research to understand children and adolescent pain experiences across contexts. We used the 7 stages of meta-ethnography to synthesise findings. We combined the strengths of arts-based methods, translating themes into poems in a range of languages. We screened 7471 titles, 464 abstracts, and 302 full texts, including 189 reports (177 unique samples) incorporating 5875 young people. Age range across studies was 2 to 38 years, with 93% including those between the age of 11 and 20 years old. Studies spanned 30 years (1993-2023) with 121 (64%) published in the last 10 years. Almost all (93%) were set-in high-income countries. We report 6 themes focusing on transition to adulthood: (1) I want to stay within the safety of home; (2) don't exclude me from my own care; (3) it might hurt but it's for my own good; (4) I rely on others but I want some independence; (5) I am no longer a child but I am not an adult yet; and (6) I wasn't prepared for the transfer to adult health care. Our findings focus on the complex transition into adulthood and the importance of creating a genuine healthcare partnership with young people by acknowledging their perspectives, creating a safe and supportive environment, and preparing them for the transition to adult pain care. Arts-based methods have the potential to make findings from qualitative evidence syntheses accessible and impactful for compassionate health care.
Development and implementation of a physiotherapy exercise intervention with tailored support for exercise adherence for people with vertebral fragility fractures (OPTIN trial)
Objectives: The OsteoPorosis Tailored exercise adherence INtervention (OPTIN) trial is a two-arm, multi-centre randomised controlled trial. It compares the effectiveness of physiotherapy exercise rehabilitation with integrated support for exercise adherence, to physiotherapy exercise rehabilitation alone, for people with vertebral fragility fracture (VFF) and back pain. This paper describes the development of the physiotherapist-led adherence enhanced intervention. Methods: We used an intervention mapping approach and followed Medical Research Council guidelines for developing complex interventions. We co-created the intervention involving expert clinicians, service managers, researchers, and adults with long-term musculoskeletal conditions, including osteoporosis. We identified a theoretical framework, reviewed the evidence, used a feasibility study, and considered clinical practice and deliverability within UK National Health Service (NHS) outpatient physiotherapy secondary care. Through a collaborative workshop, we refined the intervention, involved patients again and re-tested the intervention. Finally, we manualised the intervention, produced patient and physiotherapist materials and trained physiotherapists for delivery. Results: The OPTIN intervention uses a motivational interviewing approach and captures information about patient goals, barriers, and facilitators to exercise. Physiotherapists assess exercise capability, opportunities and motivation and utilise at least three behaviour change approaches, selecting from an intervention toolkit of nine approaches to support exercise behaviour. Ninety minutes of additional physiotherapy are provided to deliver the intervention, integrated within the assessment and six follow-up visits. Conclusions: A theory-informed intervention to support exercise adherence was developed and delivered by physiotherapists trained in the intervention to older adults with VFF and back pain in the intervention arm (n=63) of the OPTIN trial. Trial Registration number: ISRCTN 14465704.
Neuropathic pain is a feature in patients with symptomatic femoral acetabular impingement.
UNLABELLED: Femoral acetabular impingement syndrome (FAIS) is a cause of hip pain thought to be nociceptive, although pain phenotypes e.g., burning, pain attacks, prickling, numbness etc., are reported, mimicking neuropathic pain. Although no lesion to the somatosensory system is identified, neuropathic pain (NeP) may explain why nociceptive-focussed treatments are not always successful. OBJECTIVE: To identify NeP in patients with FAIS and investigate if related to poorer outcomes. DESIGN: A secondary analysis of the Femoral Acetabular Impingement Trial (FAIT). Outcome of interest: PainDETECT questionnaire; secondary outcomes of interest; International Hip Outcome Tool (iHOT33), Hospital Anxiety and Depression Scale (HADS) and VAS 'average pain over a month', at baseline and 8 months follow-up. Intervention (surgery or physiotherapy) were pooled. RESULTS: 173 data sets at baseline; 123 at 8 months follow-up. Baseline painDETECT identified three groups: 69% nociceptive, 19% unclear and 12% neuropathic pain phenotypes. Baseline, median scores were higher for the neuropathic group compared to the nociceptive group demonstrating borderline anxiety (9.5(5.3 to 14.2), 5(3 to 8), higher normal values for depression (7.5(2.3 to 11.8), (4(2 to 9), higher average pain (7 (6 to 8), 5(4 to 6) and lower iHOT33 14.2(9 to 21.1), 38.4(26.2 to 55.7). Post treatment, there was a median change in the neuropathic score in both iHOT33 (40.8 (25 to 76.5) with a median difference of 24.13 (CI 95% 10.46 to 45.92) and average pain 4.5(1.5 to 7) with a median difference of 2 (CI 95% 1 to 5) but to a lesser amount than the nociceptive group, iHOT33 (64(38.2 to 86.6) with a median difference of 15.50 (CI 95% 6.41 to 21.82) and average pain 3(1 to 5.7) with a median difference of 1 (CI 95% 0.5 to 1). CONCLUSION: NeP exists in symptomatic FAIS patients and is associated with increased average pain, and functional limitations. Nociceptive-targeted treatment improves hip function and pain but with less improvement in the NeP group when compared to the nociceptive group. Pain phenotyping before intervention may improve outcomes. CONTRIBUTION OF PAPER.
The experience of patients undergoing aseptic, elective revision knee joint replacement surgery: a qualitative study.
BACKGROUND: Around 6,000 revision knee replacement procedures are performed in the United Kingdom each year. Three-quarters of procedures are for aseptic, elective reasons, such as progressive osteoarthritis, prosthesis loosening/wear, or instability. Our understanding of how we can best support these patients undergoing revision knee replacement procedures is limited. This study aimed to explore patients' experiences of having a problematic knee replacement and the impact of undergoing knee revision surgery for aseptic, elective reasons. METHODS: Qualitative semi structured interviews with 15 patients (8 women, 7 men; mean age 70 years: range 54-81) who had undergone revision knee surgery for a range of aseptic, elective indications in the last 12 months at an NHS Major Revision Knee Centre. Interviews were audio-recorded, transcribed, de-identified and analysed using reflexive thematic analysis. RESULTS: We developed six themes: Soldiering on; The challenge of navigating the health system; I am the expert in my own knee; Shift in what I expected from surgery; I am not the person I used to be; Lingering uncertainty. CONCLUSIONS: Living with a problematic knee replacement and undergoing knee revision surgery has significant impact on all aspects of patients' lives. Our findings highlight the need for patients with problematic knee replacements to be supported to access care and assessment, and for long-term psychological and rehabilitation support before and after revision surgery.
Using evidence-based co-design to develop a hybrid delivered exercise intervention that aims to increase confidence to exercise in people with haemophilia.
INTRODUCTION: Due to advances in treatments, people with haemophilia (PWH) are living longer. They are not as active as the general population due to joint damage and lack confidence to be active due to concerns about further bleeds and pain. There is a need to facilitate healthy aging through promotion of physical activity (PA) and exercise. Changing patient beliefs and increasing physical literacy and confidence to move are thought to be key to helping PWH become more active. AIM: This paper describes the development of an exercise and behaviour change intervention to improve confidence to exercise in PWH. METHODS: The 4-stage Medical Research Council framework for complex intervention development was used. RESULTS: Stakeholders included 17 PWH and 7 physiotherapists working in haemophilia. Seven online focus group meetings were held. The final intervention is a hybrid 12-week physiotherapist led progressive exercise programme. Classes are 45 min including Pilates, High intensity interval training and balance elements, together with discussion sessions focusing on PA recommendations, the types and benefits of different exercise styles and the effects of PA, together with the effects of aging for PWH. The COM-B model of behaviour change was used to develop the intervention. CONCLUSION: Co-design helps to produce an intervention that understands the stakeholders needs. Through this process the intervention developed to incorporate not only increasing PA but also confidence to exercise. The use of behaviour change theory identified the behaviour techniques included in the intervention and aims to increase physical literacy in this population.
Effectiveness of supervised versus self-directed rehabilitation for adults aged 50 years and over with ankle fractures: protocol for the AFTER trial.
AIMS: Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. METHODS: This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation. CONCLUSION: This study will assess whether supervised rehabilitation is more effective than self-directed rehabilitation for adults aged 50 years and older after ankle fracture. The results will provide evidence to guide clinical practice. At the time of submission, the trial is currently completing recruitment, and follow-up will be completed in 2024.
