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Background Over 215,000 total hip replacements (THRs) and total knee replacements (TKRs) take place annually in the UK. Joint replacement has the longest waiting times of elective surgical treatments, with some patients waiting up to two years for surgery in the NHS. Pre-operative education and support interventions could improve both pre-operative health and optimise post-operative outcomes. However, current pre-operative NHS service provision is heterogenous and poorly described. This study aimed to describe the current services and care provided to patients on NHS waiting lists for THR and TKR. Methods A link to a national online survey about pre-operative education and prehabilitation was sent to relevant healthcare professionals involved in the pre-operative care of patients waiting for THR or TKR surgery at a sample of high-, mid- and low-volume NHS hospitals in the UK. Participants were asked questions about what pre-operative education and pre-habilitation services were offered at their hospital, and any barriers or facilitators to delivering care. Frequency statistics were used to describe categorical data and free-text data were coded into categories. Results Responses were received from 29 UK hospitals across seven regions. Pre-operative education was provided to patients at 28 hospitals, primarily at single session talks supplemented with booklets. Prehabilitation was provided to patients waiting for TKR at 17 hospitals and to patients waiting for THR at 14 hospitals. It comprised strengthening exercises and advice with written information. Three hospital respondents did not know if prehabilitation was provided before TKR and four hospitals before THR. Barriers to service provision include funding, staffing, facilities, and lack of awareness/evidence on how best to deliver services. Conclusions Prehabilitation services are not provided for all patients waiting for arthroplasty. Future work is needed to design and evaluate prehabilitation resources to optimise pre-operative health and improve patient outcomes after TKR and THR.

Background Physical activity can improve pain and wellbeing for people with osteoarthritis, including those awaiting joint replacement, for whom physical activity can improve post-operative recovery. However, people with osteoarthritis report pain as a barrier to exercise. Pain Science Education (PSE) can reframe this by addressing beliefs about pain that impact exercise. This systematic review aimed to map the content of PSE interventions for people with osteoarthritis, and evaluate the effectiveness of intervention components. Methods This review synthesised evidence on PSE and exercise interventions for people with knee or hip osteoarthritis, including those awaiting joint replacement. Databases were searched for RCTs and non-randomised studies, from inception to 1 August 2024 (MEDLINE/PsycINFO/EMBASE/PEDro). Risk of bias was assessed (RoB 2/ROBINS-I). Intervention content was analysed using content analysis. Outcomes were analysed quantitatively, including a component network meta-analysis (cNMA) of RCTs, presented parallel to non-randomised study results. Treatment effects were evaluated against PSE intervention components to understand which components impacted outcomes (pain/physical functioning/catastrophizing/kinesiophobia/self-efficacy). Results Twelve reports of 10 interventions (20–103 participants per study) were included. Content analysis identified six domains: introductory topics, acute pain mechanisms, chronic pain mechanisms, factors that sustain pain, multidisciplinary education, and exercise components. cNMA: PSE had little-to-no effect on pain and physical functioning, with beneficial effects on catastrophizing, kinesiophobia and self-efficacy. Conclusions This review highlights potential effectiveness of PSE intervention components for improving psychological outcomes for people with osteoarthritis. PSE may act as a mechanism of action for exercise interventions, and is less successful delivered standalone. PSE should be delivered using relatable examples and tailored exercises to ensure accessibility. Findings should be interpreted cautiously due to the small number of heterogeneous studies. Systematic review registration PROSPERO CRD42023488027.

For many people with advanced osteoarthritis, total knee replacement is an effective treatment to relieve pain and improve function. However, 10–34% of people experience chronic postsurgical pain in the months and years after total knee replacement. The Support and Treatment After Replacement (STAR) randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. Our objective was to identify factors promoting or inhibiting its implementation, and to inform future training and wider implementation of the pathway. We conducted a prospective process evaluation using qualitative interviews with eight Extended Scope Practitioners and six Principal Investigators from seven trial sites who were involved in delivering the STAR care pathway during the trial. We used Normalization Process Theory as a theoretical framework for qualitative data collection and content analysis. We identified that factors promoting the implementation of the pathway were quick familiarisation with the pathway, valuing patient-centredness, formalising referral processes, and increasing confidence to address neuropathic pain. Challenges to implementation were availability of time and resources, sensitivity in referral process, and ensuring collective understanding of the pathway. These findings have enabled us to make recommendations about the future implementation of the STAR care pathway and will inform the development of a training package, and updated manual for successful delivery in usual care. Furthermore, this model of care has potential value in diverse elective surgeries and pain conditions.

ObjectivesTo update our previous systematic review to synthesise latest data on the prevalence of long-term pain in patients who underwent total hip replacement (THR) or total knee replacement (TKR). We aim to describe the prevalence estimates and trends in this review.DesignSystematic review and meta-analysis.Data sourcesUpdate searches were conducted in MEDLINE and Embase databases from 1 January 2011 to 17 February 2024. Citation tracking was used to identify additional studies.Eligibility criteriaWe included prospective cohort studies reporting long-term pain after THR or TKR at 3, 6, 12 and 24 months postoperative.Data extraction and synthesisTwo reviewers independently identified studies as eligible. One reviewer conducted data extraction, checked by a second reviewer. The risk of bias assessment was performed using Hoy’s checklist. Bayesian, random-effects meta-analysis was used to synthesise the results.ResultsFor TKR, 68 studies with 89 time points, including 598 498 patients, were included. Multivariate meta-analysis showed a general decrease in pain proportions over time: 21.9% (95% CrI 15.6% to 29.4%) at 3 months, 14.1% (10.9% to 17.9%) at 6 months, 12.6% (9.9% to 15.9%) at 12 months and 14.6% (9.5% to 22.4%) at 24 months. Considerable heterogeneity, unrelated to examined moderators, was indicated by substantial prediction intervals in the univariate models. Substantial loss to follow-up and risk of bias led to low confidence in the results. For THR, only 11 studies were included, so it was not possible to describe the trend. Univariate meta-analysis estimated 13.8% (8.5% to 20.1%) and 13.7% (4.8% to 31.0%) of patients experiencing long-term pain 6 and 12 months after THR, respectively, though concerns in risk of bias results reduced confidence in these findings.ConclusionsOur review suggests that approximately 22% of patients report pain 3 months post-TKR, with 12%–15% experiencing long-term pain up to 2 years. At least 14% report pain 6–12 months after THR. Given the prevalence of chronic postsurgical pain, implementing existing and developing new preventive and management strategies is crucial for optimal patient outcomes.PROSPERO registration numberCRD42023475498.

Background Approximately 20% of people experience chronic postsurgical pain after total knee replacement. The STAR randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. We report trial participants’ experiences of postoperative pain and the acceptability of the STAR care pathway, which consisted of an assessment clinic at three months, and up to six follow-up telephone calls over 12 months. Methods Semi-structured interviews were conducted with 27 people (10 men, 17 women) between February 2018 and January 2020. Participants were sampled purposively from the care pathway intervention group and interviewed after completion of the final postoperative trial questionnaire at approximately 15 months after knee replacement. Interviews were audio-recorded, transcribed, anonymised and analysed using inductive thematic analysis. Findings Many participants were unprepared for the severity and impact of postoperative pain, which they described as extreme and constant and that tested their physical and mental endurance. Participants identified ‘low points’ during their recovery, triggered by stiffening, pain or swelling that caused feelings of anxiety, depression, and pain catastrophising. Participants described the STAR assessment clinic as something that seemed “perfectly normal” suggesting it was seamlessly integrated into NHS care. Even in the context of some ongoing pain, the STAR care pathway had provided a source of support and an opportunity to discuss concerns about their ongoing recovery. Conclusions People who have knee replacement may be unprepared for the severity and impact of postoperative pain, and the hard work of recovery afterwards. This highlights the challenges of preparing patients for total knee replacement and suggests that clinical attention is needed if exercise and mobilising is painful beyond the three month postoperative period. The STAR care pathway is acceptable to people with pain after total knee replacement.

Background Sleep is substantial issue for hospital inpatients and can negatively affect healing and recovery. There is a good evidence-base for interventions which can improve sleep, however currently they are not being implemented into NHS practice. To address the evidence-practice gap, we have conducted early-phase development for an inpatient sleep intervention (ASLEEP); a multi-level intervention to improve inpatient sleep in UK hospital wards. Methods We used an iterative development process incorporating Patient and Public Involvement and Engagement, ward staff surveys and stakeholder consultations (orthopaedic and acute medicine), and theoretical mapping using behaviour change theories. Development took place in four stages: identification of existing patient-level intervention components to improve sleep in hospital; identification of environmental barriers and facilitators to sleep in hospital; consultation with health professional stakeholders; and final theoretical mapping using the COM-B model and Theoretical Domains Framework, also considering who holds ‘change power’ for each change construct. Results We identified 18 variables contributing to inpatient sleep, which are malleable to change universally across hospital wards. Central domains for change were identified as the ward environment context and resources; to reduce noise from equipment (material resources), and social influence; to modulate staff and patient noise awareness and behaviours (group norms). Change power mapping identified key stakeholders as patients, ward staff, procurement/estates, and NHS management. Conclusions Improving sleep in hospital requires a whole-systems approach which targets environmental factors, staff behaviour, and patient behaviour. We have provided recommendations for a multi-level intervention, highlighting core areas for change and essential stakeholders who must be involved to progress implementation. The next stage of development will involve operationalising recommendations and piloting, including evaluating mechanisms of change. It will be important to continue working with a broad range of stakeholders to bridge the evidence-practice gap and support sustainable practice adoption.

ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) to evaluate a prehabilitation programme for frail patients undergoing total hip replacement (THR) or total knee replacement (TKR).DesignRandomised feasibility study with embedded qualitative work.SettingThree National Health Service hospitals.ParticipantsAdults aged ≥65 years, frail and scheduled for primary THR or TKR.InterventionAppointment with a physiotherapist to individualise a home-based exercise programme. Participants were encouraged to do the home exercises daily for 12 weeks pre-operative and were provided with a daily protein supplement. Participants were supported by six telephone calls over the 12-week intervention period.Outcome measuresEligibility and recruitment rates, intervention adherence, data completion rates of patient-reported outcome measures, retention rates and acceptability of the trial and intervention. Qualitative interviews were conducted with participants and non-participants and analysed using thematic analysis.ResultsBetween December 2022 and August 2023, 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants (73%) completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% (55/64 overall) at 12 weeks. The 12-week follow-up questionnaire was returned by 46 of the 55 participants (84%) who were sent a questionnaire. Interviews with 19 patients found that the trial processes and intervention were generally acceptable, but areas of potential improvements were identified.ConclusionsThis study demonstrated that a larger study is possible and has identified improvements to optimise the design of an RCT.Trial registration numberISRCTN11121506.

Background The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. Methods Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0–10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. Results Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p  = 0.20) for pain severity and − 0.64 (95% CI -1.41, 0.12); p  = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. Conclusions The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. Trial registration ISRCTN: 92,545,361.

Background Whether there is sufficient capacity and capability for the successful conduct and delivery of a clinical trial should be assessed by several stakeholders according to transparent and evidence-based criteria during trial planning. For this openly shared, user-tested, and validated tools are necessary. Therefore, we systematically examined the public availability and content of checklists which assess the study-level feasibility in the planning phase of clinical trials. Methods In our scoping review we systematically searched Medline, EMBASE, and Google (last search, June 2021). We included all publicly available checklists or tools that assessed study level feasibility of clinical trials, examined their content, and checked whether they were user-tested or validated in any form. Data was analysed and synthesised using conventional content analysis. Results A total of 10 publicly available checklists from five countries were identified. The checklists included 48 distinct items that were classified according to the following seven different domains of clinical trial feasibility: regulation, review and oversight; participant recruitment; space, material and equipment; financial resources; trial team resources; trial management; and pilot or feasibility studies. None of the available checklists appeared to be user-tested or validated. Conclusions Although a number of publicly available checklists to assess the feasibility of clinical trials exist, their reliability and usefulness remain unclear. Openly shared, user-tested, and validated feasibility assessment tools for a better planning of clinical trials are lacking.

ObjectivesTo test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.DesignFeasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.SettingTwo National Health Service (NHS) secondary care hospitals in England and Wales.ParticipantsPreoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.InterventionThe REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.Outcome measuresThe primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.ResultsScreening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.ConclusionsThis feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.Trial registration numberISRCTN14233189.