Fear-avoidant beliefs and behaviours after upper limb fracture in older people: a systematic review and meta-ethnography.

PURPOSE: This systematic review aimed to understand older people's perspectives of associated fear-avoidant beliefs following upper limb fracture. METHODS: Published and unpublished literature databases were systematically searched from inception to 1st April 2023. Qualitative studies reporting the perspectives of fear-avoidant beliefs or behaviours in people who had sustained an upper limb fracture were eligible. Data extracted included characteristics of people interviewed, experiences and perceptions of fear, fear of falling, and fear-avoidant beliefs and behaviours. Data were synthesised using a meta-ethnography approach and the GRADE-CERQUAL tool. RESULTS: Eight studies were eligible (n = 150 participants; 109 distal radial/41 humeral fracture). Three overarching themes were identified: (1) type of fear-avoidant experiences, (2) drivers of fear-avoidant beliefs and behaviours, and (3) consequences of fear-avoidant beliefs and behaviours. The themes generated were based on moderate confidence evidence. In summary, whilst some patients initially consider upper limb fractures to be relatively minor injuries, over time, the realisation occurs that they have wide-ranging consequences with longer-term perspectives on recovery. This often occurs following an initial period of reduced fear. Providing education and support immediately post-fracture to prevent or challenge initial health beliefs around fear of falls and fear of movement is imperative to recovery. CONCLUSIONS: Fear-avoidant beliefs can impact heavily on certain older people's recovery, as well as their longer-term health and wellbeing. Consideration of fear avoidance and taking steps to mitigate against this in the acute upper limb trauma setting will better serve these patients in their ongoing recovery from injury.

Physical activity and health-related quality of life of patients with chronic knee pain after total knee replacement: Analysis of the PEP-TALK trial.

BACKGROUND: Chronic pain is a major challenge for some people after total knee replacement (TKR). The changing impact of this complication during the first post-operative year remains unclear. This analysis aimed to examine how physical activity and health-related quality of life (HRQoL) evolved over the first year after TKR for patients with and without post-operative chronic knee pain. METHODS: We conducted a secondary analysis of data from a randomised controlled trial (PEP-TALK), which tested the effectiveness of a behaviour change physiotherapy intervention compared with usual rehabilitation after TKR. Mean UCLA Activity Score and EQ-5D-5L for participants with and without chronic knee pain (14 points or lower in the Oxford Knee Score Pain Subscale (OKS-PS) at six months post-TKR) were compared at six and 12 months post-TKR. RESULTS: Data from 83 participants were analysed. For those with chronic knee pain, UCLA Activity Score remained unchanged between baseline to six months (mean: 3.8 to 3.8), decreasing at 12 months (3.0). Those without post-operative chronic knee pain reported improved physical activity from baseline to six months (4.0 vs 4.9), plateauing at 12 months (4.9). Participants with chronic knee pain reported lower baseline HRQoL (0.28 vs 0.48). Both groups improved health utility over one year. Of those without chronic pain at six months, 8.5% returned to chronic pain by 12 months. CONCLUSIONS: Monitoring clinical outcomes after six months may be indicated for those at risk of chronic pain post-TKR. Further, sufficiently powered analyses are warranted to increase the generalisability of this exploratory analyses' results.

Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England.

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.

The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review.

Chronic pain (CP) and mental illness (MI) are leading causes of years lived with disability and commonly co-occur. However, it remains unclear if available interventions are effective in improving pain outcomes in patients with co-existing CP and MI. This systematic review synthesised evidence for the effectiveness of interventions to improve pain outcomes for people with comorbid CP and clinically diagnosed MI. Ten electronic databases were searched from inception until May 2023. Randomised controlled trials (RCTs) were included if they evaluated interventions for CP-related outcomes among people with comorbid CP and clinically diagnosed MI. Pain-related and mental health outcomes were reported as primary and secondary outcomes, respectively. 26 RCTs (2,311 participants) were included. Four trials evaluated the effectiveness of cognitive-behavioural therapy, 6 mindfulness-based interventions, 1 interpersonal psychotherapy, 5 body-based interventions, 5 multi-component interventions, and 5 examined pharmacological-based interventions. Overall, there was considerable heterogeneity in sample characteristics and interventions, and included studies were generally of poor quality with insufficient trial details being reported. Despite the inconsistency in results, preliminary evidence suggests interventions demonstrating a positive effect on CP may include cognitive-behavioural therapy for patients with depression (with a small to medium effect size) and multi-component intervention for people with substance use disorders (with a small effect size). Despite the high occurrence/burden of CP and MI, there is a relative paucity of RCTs investigating interventions and none in people with severe MI. More rigorously designed RCTs are needed to further support our findings. PERSPECTIVE: This systematic review presents current evidence evaluating interventions for CP-related and MH outcomes for people with comorbid CP and clinically diagnosed MI. Our findings could potentially help clinicians identify the most effective treatments to manage these symptoms for this vulnerable patient group.

Understanding triage assessment of acuity by emergency nurses at initial adult patient presentation: A qualitative systematic review.

BACKGROUND: Nurses make complex triage decisions within emergency departments, which significantly affect patient outcomes. Understanding how nurses make these decisions and why they deviate from triage algorithms facilitates interventions that work with their decision-making processes, increasing acceptability and effectiveness. AIMS: This qualitative systematic review aimed to understand decision-making processes emergency nurses use to make acuity decisions during triage assessment at initial patient presentation. METHODOLOGY: Medline, CINAHL and Academic Search Complete were systematically searched to 15th December 2022. Data were analysed using thematic synthesis. Established themes were reviewed with GRADE-CERQual to evaluate certainty of evidence. RESULTS: 28 studies were included in the review. Data analysis uncovered three superordinate themes of holistic reasoning, situational awareness, and informed decision-making. The findings show nurses value holistic assessments over algorithms and rely on knowledge and experience. They also assess the wider situation in the emergency department. CONCLUSIONS: This review presents new perspectives on nurses' decision-making processes about patient's acuity. Nurses holistically gather information about patients before translating that information into acuity scores. These actions are informed by their knowledge and experience; however, the wider situation also impacts their decisions. In turn, the nurses use interpretations of patients' acuity to control the wider situation.

Unpaid caregiving for people following hip fracture: longitudinal analysis from the English Longitudinal Study of Ageing.

PURPOSE: To determine the provision and its change over time in unpaid care for people following hip fracture. METHODS: Data were sought from the English Longitudinal Study of Ageing (ELSA) cohort. We identified participants who self-reported experiencing a hip fracture, who had clinical and caregiving data in the previous and subsequent two data collection waves. Demographic and clinical data were collected in addition to data on provision of unpaid care, who provided care and the frequency of needs being met. RESULTS: The analysed cohort consisted of 246 participants [150 females (61%), mean age 78.9 years (standard deviation: 8.6)]. There was an increase in the number of participants requiring unpaid care between the Pre-Fracture and Fracture Wave (29% vs. 59%), which plateaued in the subsequent two waves (56%; 51%). Although both spouse and daughters provided the most unpaid care to participants over this study period, there was an increase in support provided during the Fracture Wave by both sons and daughters. This increased support offered by spouses continued until Post-Fracture Wave 2 when this plateaued. Support provided by friends increased from 3 to 8% and brothers and sisters increased from 0 and 1% Pre-Fracture to 8% by Post-Fracture Wave 2. CONCLUSION: These findings provide insights into who, what and how unpaid carers support people following hip fracture over time. Given the level of support unpaid carers offer, and previously reported carer stress and burden, undertaking clinical trials to assess the effectiveness of carer-patient support interventions would be valuable.

Supporting patients to prepare for total knee replacement: Evidence-, theory- and person-based development of a 'Virtual Knee School' digital intervention.

INTRODUCTION: Digital delivery of pre-operative total knee replacement (TKR) education and prehabilitation could improve patient outcomes pre- and post-operatively. Rigorously developing digital interventions is vital to help ensure they achieve their intended outcomes whilst mitigating their potential drawbacks. OBJECTIVE: To develop a pre-operative TKR education and prehabilitation digital intervention, the 'Virtual Knee School' (VKS). METHODS: The VKS was developed using an evidence-, theory- and person-based approach. This involved a mixed methods design with four phases. The first three focused on planning the VKS. The final phase involved creating a VKS prototype and iteratively refining it through concurrent think-aloud interviews with nine patients who were awaiting/had undergone TKR. Meta-inferences were generated by integrating findings from all the phases. ISRCTN registration of the overall project was obtained on 24 April 2020 (ISRCTN11759773). RESULTS: Most participants found the VKS prototype acceptable overall and considered it a valuable resource. Conversely, a minority of participants felt the prototype's digital format or content did not meet their individual needs. Participants' feedback was used to refine the prototype's information architecture, design and content. Two meta-inferences were generated and recommend: 1. Comprehensive pre-operative TKR education and prehabilitation support should be rapidly accessible in digital and non-digital formats. 2. Pre-operative TKR digital interventions should employ computer- and self-tailoring to account for patients' individual needs and preferences. CONCLUSIONS: Integrating evidence, theory and stakeholders' perspectives enabled the development of a promising VKS digital intervention for patients awaiting TKR. The findings suggest future research evaluating the VKS is warranted and provide recommendations for optimising pre-operative TKR care. PATIENT OR PUBLIC CONTRIBUTION: Patient and Public Involvement (PPI) was central throughout the project. For example, PPI representatives contributed to the project planning, were valued members of the Project Advisory Group, had key roles in developing the VKS prototype and helped disseminate the project findings.

Outcomes in Ankle Replacement Study (OARS).

Aims: The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures. Methods: Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics. Results: Data from 238 patients were analyzed. There were significant improvements in MOXFQ and EQ-5D-5L among people who underwent TAA at six- and 12-month assessments compared with preoperative scores (p < 0.001). Most improvement occurred between preoperative and six months, with little further improvement at 12 months. A greater improvement in MOXFQ outcome postoperatively was associated with older age and more advanced radiological signs of ankle osteoarthritis at baseline. Conclusion: TAA significantly benefits patients with end-stage ankle disease. The lack of substantial further overall change between six and 12 months suggests that capturing PROMs at six months is sufficient to assess the success of the procedure. Older patients and those with advanced radiological disease had the greater gains. These outcome predictors can be used to counsel younger patients and those with earlier ankle disease on the expectations of TAA.

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.

Frequency, duration, and type of physiotherapy in the week after hip fracture surgery - analysis of implications for discharge home, readmission, survival, and recovery of mobility.

PURPOSE: To examine the association between physiotherapy access after hip fracture and discharge home, readmission, survival, and mobility recovery. METHODS: A 2017 Physiotherapy Hip Fracture Sprint Audit was linked to hospital records for 5383 patients. Logistic regression was used to estimate the association between physiotherapy access in the first postoperative week and discharge home, 30-day readmission post-discharge, 30-day survival and 120-days mobility recovery post-admission adjusted for age, sex, American Society of Anesthesiology grade, Hospital Frailty Risk Score and prefracture mobility/residence. RESULTS: Overall, 73% were female and 40% had high frailty risk. Patients who received ≥2 hours of physiotherapy (versus less) had 3% (95% Confidence Interval: 0-6%), 4% (2-6%), and 6% (1-11%) higher adjusted probabilities of discharge home, survival, and outdoor mobility recovery, and 3% (0-6%) lower adjusted probability of readmission. Recipients of exercise (versus mobilisation alone) had 6% (1-12%), 3% (0-7%), and 11% (3-18%) higher adjusted probabilities of discharge home, survival, and outdoor mobility recovery, and 6% (2-10%) lower adjusted probability of readmission. Recipients of 6-7 days physiotherapy (versus 0-2 days) had 8% (5-11%) higher adjusted probability of survival. For patients with dementia, improved probability of survival, discharge home, readmission and indoor mobility recovery were observed with greater physiotherapy access. CONCLUSION: Greater access to physiotherapy was associated with a higher probability of positive outcomes. For every 100 patients, greater access could equate to an additional eight patients surviving to 30-days and six avoiding 30-day readmission. The findings suggest a potential benefit in terms of home discharge and outdoor mobility recovery. CONTRIBUTION OF THE PAPER.

Bringing the Walk with Ease Programme to the UK: a mixed-methods study to assess the relevance, acceptability, and feasibility of implementation for people with arthritis and musculoskeletal conditions.

Developed in the United States (US), Walk With Ease (WWE) is a popular evidence-based, 6-week community walking programme for adults with arthritis, delivered in either an instructor-led or self-directed format. While WWE has expanded into communities across the USA, it is relatively unknown in other countries across the globe. This study, in collaboration with community and patient partners, aimed to examine the relevance, acceptability and feasibility of introducing WWE into a UK context. After initial cultural adaptation, participants were recruited into the study. Eligible (≥18 years, doctor diagnosed arthritis (confirmed or self-report), self-reported joint symptoms in last 30 days, BMI ≥25 kg/m2, and <150 min/week of moderate/vigorous PA) and consented participants were randomized into two groups: WWE programme or usual care. A mixed-methods analysis approach integrated quantitative data (physical performance assessment; baseline and post-six week programme questionnaire) and qualitative data (narrative interviews exploring participants' pre- and post-WWE experiences and stakeholders' perceptions). Of 149 participants, the majority were women (70%) aged ≥60 years (76%). Among the 97 receiving the programme, 52 chose instructor-led; 45 chose self-directed. Participants found WWE relevant and acceptable-99% indicating they would recommend WWE to family/friends. Within both WWE formats, mixed differences representing improvement were observed at 6 weeks from baseline for physical performance and arthritis symptoms. Emergent themes included improved motivation, health, and social well-being. WWE is a relevant and acceptable walking programme with scope for wider implementation to support UK health and well-being policy strategies.

Walk With Ease (WWE) is a popular walking programme in the USA. It was specially designed for people living with arthritis and musculoskeletal conditions. Over 6-weeks, participants follow a guidebook and can choose to walk by themselves or with an instructor-led group. Research evidence has shown that WWE increases time spent being physically active and improves arthritis symptoms. We wanted to bring WWE across the pond to explore whether it would be well-received and possible to conduct in the UK. We worked with community and patient partners to make sure the WWE materials made sense for a British audience and trained walk leaders. We recruited participants and asked them to complete physical assessment tests, questionnaires, and interviews both before and after the 6-week walking programme. There were 149 participants who took part­most were older women­and 97 participants received the WWE programme. Almost all (99%) would recommend WWE to family and friends. They said, in the interviews, that the programme improved their motivation to be physically active, helped their mood, and social well-being. Their physical performance and arthritis symptoms also improved. WWE has great potential to improve health and well-being of people with arthritis in the UK.

Developing a core outcome set for foot and ankle disorders in rheumatic and musculoskeletal diseases: A scoping review and report from the OMERACT 2022 foot and ankle special interest group session.

OBJECTIVES: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases, yet high-quality evidence assessing the effectiveness of treatments for these disorders is lacking. The Outcome Measures in Rheumatology (OMERACT) Foot and Ankle Working Group is developing a core outcome set for use in clinical trials and longitudinal observational studies in this area. METHODS: A scoping review was performed to identify outcome domains in the existing literature. Clinical trials and observational studies comparing pharmacological, conservative or surgical interventions involving adult participants with any foot or ankle disorder in the following rheumatic and musculoskeletal diseases (RMDs) were eligible for inclusion: rheumatoid arthritis (RA), osteoarthritis (OA), spondyloarthropathies, crystal arthropathies and connective tissue diseases. Outcome domains were categorised according to the OMERACT Filter 2.1. RESULTS: Outcome domains were extracted from 150 eligible studies. Most studies included participants with foot/ankle OA (63% of studies) or foot/ankle involvement in RA (29% of studies). Foot/ankle pain was the outcome domain most commonly measured (78% of studies), being the most frequently specified outcome domain across all RMDs. There was considerable heterogeneity in the other outcome domains measured, across core areas of manifestations (signs, symptoms, biomarkers), life impact, and societal/resource use. The group's progress to date, including findings from the scoping review, was presented and discussed during a virtual OMERACT Special Interest Group (SIG) in October 2022. During this meeting, feedback was sought amongst delegates regarding the scope of the core outcome set, and feedback was received on the next steps of the project, including focus group and Delphi methods. CONCLUSION: Findings from the scoping review and feedback from the SIG will contribute to the development of a core outcome set for foot and ankle disorders in RMDs. The next steps are to determine which outcome domains are important to patients, followed by a Delphi exercise with key stakeholders to prioritise outcome domains.

Getting Recovery Right After Neck Dissection (GRRAND-F): Mixed-methods feasibility study to design a pragmatic randomised controlled trial.

Objective: To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC). Design: Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial. Setting: Two UK NHS hospitals. Participants: People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six months or less, pre-existing, long-term neurological disease affecting the shoulder and cognitive impairment. Intervention: Usual care (standard care supplemented with a booklet on postoperative self-management) was received by all participants. The GRRAND intervention programme consisted of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion and progressive resistance exercises, advice and education. Between sessions, participants were advised to complete a home exercise programme. Randomisation: 1:1 randomisation. Allocation was based on minimisation, stratified by hospital site and spinal accessory nerve sacrifice. It was not possible to mask treatment received. Main outcome measures: Primary: Participant recruitment, retention and fidelity to the study protocol and interventions from study participants and staff at six months post-randomisation (and 12 months for those reaching that time-point). Secondary: clinical measures of pain, function, physical performance, health-related quality of life, health utilisation and adverse events. Results: 36 participants were recruited and enrolled. The study achieved five of its six feasibility targets. These included consent - 70% of eligible participants were consented; intervention fidelity - 78% participants discharged completed the intervention sessions; contamination - none - no participants in the control arm received the GRRAND-F intervention and retention - 8% of participants were lost to follow-up. The only feasibility target that was not achieved was the recruitment target where only 36 of the planned 60 participants were recruited over 18 months. This was principally due to the COVID-19 pandemic which caused all research activity to be paused or reduced, with a subsequent reduction in. Conclusions: Based on the findings a full-trial can now be designed to better understand whether this proposed intervention is effective. Clinical Trial Registration: https://www.isrctn.com/ISRCTN1197999, identifier ISRCTN11979997.

Pain management for people with dementia: a cross-setting systematic review and meta-ethnography.

Background: Pain management for people with dementia is challenging. There is limited understanding on the experiences of pain management from people with dementia, but also from those who support them. This study synthesised the qualitative evidence to explore the perspectives of people with dementia, their family, friends, carers and healthcare professionals to pain management. Methods: A systematic literature review was undertaken of published and unpublished literature databases (to 01 November 2021). All qualitative research studies reporting the perspectives of people with dementia, their family, friends, carers and healthcare professionals to managing pain were included. Eligible studies were appraised using the Critical Appraisal Skills Programme (CASP) qualitative appraisal tool. A meta-ethnography analysis approach was adopted, with findings assessed against the GRADE-CERQual framework. Results: Of the 3994 citations screened, 33 studies were eligible. Seven themes were identified from the data. There was moderate evidence from six studies indicating inequity of pain management for people with dementia. There was moderate evidence from 22 studies regarding anxieties on cascading pain information. There was moderate evidence from nine studies that familiarisation of the person with pain, their preferences, routines and behaviours were key factors to better pain management. Consistently, carers and healthcare professionals had a low opinion of the management of pain for people with dementia, with tensions over the 'best' treatment options to offer. This was associated with poor training and understanding on how pain 'should' be managed. Conclusion: The findings highlight the challenges faced by people with dementia and pain, and those who support them. Improvements in education for people who support these individuals would be valuable across health and social care pathways. Supporting family members and relatives on pain experiences and treatment options could improve awareness to improve quality of life for people with dementia and pain and those who support them.

Developing an Outcome Measures in Rheumatology (OMERACT) Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT): core domain set study protocol.

BACKGROUND: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). METHODS: COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. CONCLUSIONS: This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. TRIAL REGISTRATION: This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081.

Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial.

OBJECTIVES: To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II). SETTING: Patients were recruited from an NHS University Hospital between July 2018 and October 2019 with surgery at two sites. Biomechanical and functional capacity measurements were at a University Movement and Exercise Laboratory. PARTICIPANTS: 80 participants undergoing single-stage TKR. INTERVENTIONS: Patients were randomised to receive either the Journey II BCS (JII-BCS) or Genesis II TKR. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was the Oxford Knee Score (OKS), at 6 months. Secondary outcomes were: OKS Activity and Participation Questionnaire, EQ-5D-5L and UCLA Activity scores, Timed Up and Go Test, 6 min walk test, lower limb kinematics and lower limb muscle activity during walking and balance. RESULTS: This study found no difference in the OKS between groups. The OKS scores for the JII-BCS and Genesis II groups were mean (SD) 42.97 (5.21) and 43.13 (5.20) respectively, adjusted effect size 0.35 (-2.01,2.71) p=0.771In secondary outcome measures, the Genesis II group demonstrated a significantly greater walking range-of-movement (50.62 (7.33) vs 46.07 (7.71) degrees, adjusted effect size, 3.14 (0.61,5.68) p=0.02) and higher peak knee flexion angular velocity during walking (mean (SD) 307.69 (38.96) vs 330.38 (41.40) degrees/second, adjusted effect size was 21.75 (4.54,38.96), p=0.01) and better postural control (smaller resultant centre of path length) during quiet standing than the JII-BCS group (mean (SD) 158.14 (65.40) vs 235.48 (176.94) mm, adjusted effect size, 59.91 (-105.98, -13.85) p=0.01.). CONCLUSIONS: In this study population, the findings do not support the hypothesis that the Journey II BCS produces a better outcome than the Genesis II for the primary outcome of the OKS at 6 months after surgery. TRIAL REGISTRATION NUMBER: ISRCTN32315753.

Surgical versus non-surgical interventions for treating patellar dislocation.

BACKGROUND: Patellar (knee cap) dislocation occurs when the patella disengages completely from the trochlear (femoral) groove. It affects up to 42/100,000 people, and is most prevalent in those aged 20 to 30 years old. It is uncertain whether surgical or non-surgical treatment is the best approach. This is important as recurrent dislocation occurs in up to 40% of people who experience a first time (primary) dislocation. This can reduce quality of life and as a result people have to modify their lifestyle. This review is needed to determine whether surgical or non-surgical treatment should be offered to people after patellar dislocation. OBJECTIVES: To assess the effects (benefits and harms) of surgical versus non-surgical interventions for treating people with primary or recurrent patellar dislocation. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, AMED, CINAHL, Physiotherapy Evidence Database and trial registries in December 2021. We contacted corresponding authors to identify additional studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled clinical trials evaluating surgical versus non-surgical interventions for treating primary or recurrent lateral patellar dislocation in adults or children. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent patellar dislocation, and patient-rated knee and physical function scores. Our secondary outcomes were health-related quality of life, return to former activities, knee pain during activity or at rest, adverse events, patient-reported satisfaction, patient-reported knee instability symptoms and subsequent requirement for knee surgery. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included 10 studies (eight randomised controlled trials (RCTs) and two quasi-RCTs) of 519 participants with patellar dislocation. The mean ages in the individual studies ranged from 13.0 to 27.2 years. Four studies included children, mainly adolescents, as well as adults; two only recruited children. Study follow-up ranged from one to 14 years. We are unsure of the evidence for all outcomes in this review because we judged the certainty of the evidence to be very low. We downgraded each outcome by three levels. Reasons included imprecision (when fewer than 100 events were reported or the confidence interval (CI) indicated appreciable benefits as well as harms), risk of bias (when studies were at high risk of performance, detection and attrition bias), and inconsistency (in the event that pooled analysis included high levels of statistical heterogeneity). We are uncertain whether surgery lowers the risk of recurrent dislocation following primary patellar dislocation compared with non-surgical management at two to nine year follow-up. Based on an illustrative risk of recurrent dislocation in 348 people per 1000 in the non-surgical group, we found that 157 fewer people per 1000 (95% CI 209 fewer to 87 fewer) had recurrent dislocation between two and nine years after surgery (8 studies, 438 participants). We are uncertain whether surgery improves patient-rated knee and function scores. Studies measured this outcome using different scales (the Tegner activity scale, Knee Injury and Osteoarthritis Outcome Score, Lysholm, Kujala Patellofemoral Disorders score and Hughston visual analogue scale). The most frequently reported score was the Kujala Patellofemoral Disorders score. This indicated people in the surgical group had a mean score of 5.73 points higher at two to nine year follow-up (95% CI 2.91 lower to 14.37 higher; 7 studies, 401 participants). On this 100-point scale, higher scores indicate better function, and a change score of 10 points is considered to be clinically meaningful; therefore, this CI includes a possible meaningful improvement. We are uncertain whether surgery increases the risk of adverse events. Based on an assumed risk of overall incidence of complications during the first two years in 277 people out of 1000 in the non-surgical group, 335 more people per 1000 (95% CI 75 fewer to 723 more) had an adverse event in the surgery group (2 studies, 144 participants). Three studies (176 participants) assessed participant satisfaction at two to nine year follow-up, reporting little difference between groups. Based on an assumed risk of 763 per 1000 non-surgical participants reporting excellent or good outcomes, seven more participants per 1000 (95% CI 199 fewer to 237 more) reported excellent or good satisfaction. Four studies (256 participants) assessed recurrent patellar subluxation at two to nine year follow-up. Based on an assumed risk of patellar subluxation in 292 out of 1000 in the non-surgical group, 73 fewer people per 1000 (95% CI 146 fewer to 35 more) had patellar subluxation as a result of surgery. Slightly more people had subsequent surgery in the non-surgical group. Pooled two to nine year follow-up data from three trials (195 participants) indicated that, based on an assumed risk of subsequent surgery in 215 people per 1000 in the non-surgical group, 118 fewer people per 1000 (95% CI 200 fewer to 372 more) had subsequent surgery after primary surgery. AUTHORS' CONCLUSIONS: We are uncertain whether surgery improves outcome compared to non-surgical management as the certainty of the evidence was very low. No sufficiently powered trial has examined people with recurrent patellar dislocation. Adequately powered, multicentre, randomised trials are needed. To inform the design and conduct of these trials, expert consensus should be achieved on the minimal description of both surgical and non-surgical interventions, and the pathological variations that may be relevant to both choice of these interventions.

Association between Patellofemoral Anatomy and Chondral Lesions of the Knee in Patellofemoral Instability.

Chondral injury is a serious consequence of patellar dislocation and patellofemoral instability (PFI). There is limited data on the relationship between radiological features such as sulcus angle and patellar height to the presence, location, and severity of chondral lesions. The purpose of this study was to determine the association of anatomical variants in patellofemoral instability with injuries sustained due to patellar dislocation. A cohort of 101 patients who had four or more episodes of dislocation or instability undergoing isolated arthroscopy or arthroscopies at the time of corrective realignment surgery were identified. The prevalence of chondral, ligamentous, and meniscal injuries was determined and correlated to the sulcus angle, tibial tubercle trochlear groove distance, and patellar height on magnetic resonance imaging (MRI) scans. A total of 101 patients was identified. At arthroscopy, the patella demonstrated the highest incidence of chondral injury (68%) followed by the trochlear groove (40%). Lateral meniscal injuries were noted in 6% of patients, medial meniscal injuries in 2%, and anterior cruciate ligament (ACL) injury in 3%. Chondral injuries were graded using the Outerbridge criteria and there was a correlation between more severe chondral injuries and a greater tilt angle (p = 0.05). The occurrence of injury to the lateral meniscus was associated with a higher Insall-Salvati ratio (p = 0.05). More severe chondral injuries are seen in patients with a greater tilt angle.

Surgeon and physiotherapist approaches to operative or non-operative management of people with recurrent patellar dislocation: A case-based UK survey.

BACKGROUND: Physiotherapists are often key decision-makers on when to refer patients with recurrent patellar dislocation for surgical opinion. Limited guidance exists to aid this decision. Differences in orthopaedic surgeons' and physiotherapists' views on which patients and when to refer people for surgical consideration or non-operative care may affect outcome. This study aimed to explore orthopaedic surgeons and physiotherapists decision-making surrounding treatment opinions for patients with recurrent patellar dislocation. METHODS: An online survey performed. UK registered and practicing orthopaedic surgeons and physiotherapists were invited to participate. The survey utilised two vignettes and a series of related questions to ascertain respondents' views on decision-making to surgical referral for people with recurrent patellar dislocation. Data were analysed using descriptive statistics and inferential statistical tests to explore factors related to responses. RESULTS: Eighty four respondent surveys were analysed (38 surgeons, 46 physiotherapists). Overall, there was a low level of agreement amongst respondents for the management of the vignettes (k = 0.215, p = < 0.0005). Some disparity existed between the professions on the definition of recurrent patellar dislocations and the clinical features which may require an early surgical assessment. Physiotherapists were three times more likely to delay a surgical opinion for the vignettes presented in this study than the surgeons. CONCLUSION: This is the first study to investigate orthopaedic surgeons' and physiotherapists' views on decision-making around surgical or non-operative management for recurrent patellar dislocations. High-quality research is required to underpin explicit guidance on decision-making regarding management of recurrent patellar dislocation.