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.

Supporting the parent-to-child transfer of self-management responsibility for chronic kidney disease: A qualitative study.

INTRODUCTION: As children with long-term conditions (LTCs) mature, they are usually expected to assume responsibility from their parents for self-management of their condition. Little is known about what supports families with this handover of responsibility, including the role of healthcare professionals (HCPs). This study aimed to explore what supports young people with chronic kidney disease (CKD) to assume self-management responsibility and parents to relinquish control. METHODS: A qualitative study, using a grounded theory approach was conducted. Individual and dyadic interviews and focus groups were carried out with 16 young people aged 13-17 years old with CKD, 13 parents, and 20 HCPs. Participants were recruited from two UK children's renal units. FINDINGS: Building and maintaining trust, fostering positivity, learning from mistakes, forming partnerships and individualized support, facilitated the transfer of self-management responsibility. However, HCPs' focus on developing partnerships with young people meant some parents felt excluded, highlighting uncertainty around whether support should be child- or family-centred. Although tailored support was identified as critical, aspects of local service provision appeared to impact on HCPs' capacity to implement individualized approaches. CONCLUSION: This study has identified what supports the handover of responsibility, and, importantly, HCPs' current, and potential role in helping young people to assume responsibility for managing their LTC. Further research is needed to explore how HCPs' involvement balances child- and family-centred care, and how HCPs can adopt personalized, strengths-based approaches to help ensure the support that families receive is tailored to their individual needs. PATIENT OR PUBLIC CONTRIBUTION: Patient and public involvement was integrated throughout the study, with young adults with CKD and parents who had a child with CKD actively involved in the study's design and delivery.

Home-Based Health Care Interventions for People Aged 75 Years and Above With Chronic, Noninflammatory Musculoskeletal Pain: A Scoping Review.

BACKGROUND AND PURPOSE: Chronic, noninflammatory musculoskeletal pain is common in the aged population and management can be challenging for older people due to multimorbidity, social isolation, and physical frailty. The aim of this scoping review is to summarize and discuss the evidence related to home-based health care interventions for older adults, with chronic, musculoskeletal pain. METHODS: A review of the literature using 8 electronic databases (Embase, MEDLINE, CINAHL, PubMed, Cochrane Library, Physiotherapy Evidence Database [PEDro], Scopus, and Web of Science) was performed, following the PRISMA-ScR guidelines. English language published studies that assessed home-based health care intervention/s, in men and women 75 years and older, with chronic, noninflammatory musculoskeletal pain where included. Two authors independently reviewed the articles and extracted data into a preformulated chart. RESULTS AND DISCUSSION: The database search identified 4722 studies of which 7 studies met the inclusion criteria. Six of the 7 studies were randomized controlled trials and 5 studies focused on a single-site pain. The type of home-based interventions in the included studies was physical therapy (n = 2), psychotherapy (n = 3), and multimodal therapy (combination of multiple therapies) (n = 2). Participation completion rate was more than 74% in 6 out of 7 studies. Most studies used pain and/or physical function as their primary outcome (n = 6). Music therapy showed a statistically significant reduction in visual analog scale score for pain, and there was a trend toward improvement of pain and function in the physical therapy studies. No significant differences in outcomes between intervention and control groups were observed in the multimodal studies. CONCLUSION: This review highlights the scarcity of evidence related to home-based health interventions in older people 75 years and older, living with chronic, noninflammatory musculoskeletal pain. The findings were that physical, psychotherapeutic, and multimodal interventions are usually well tolerated and can be delivered as a safe self-management option. There remains a substantial need for more high-quality research with wider range of home-based interventions and comprehensive assessment of outcomes for this age group.

Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial.

INTRODUCTION: Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: 'My Knee UK' and 'Group E-Rehab'. METHODS AND ANALYSIS: This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The 'My Knee UK' intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the 'Group E-Rehab' intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care. ETHICS AND DISSEMINATION: The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN15564385.

Content and delivery of pre-operative interventions for patients undergoing total knee replacement: a rapid review.

BACKGROUND: Total knee replacement (TKR) is a common operation typically performed for end-stage knee osteoarthritis. Patients awaiting TKR often have poor health-related quality of life. Approximately 20% of patients experience persistent pain post-TKR. Pre-operative TKR interventions could improve pre- and post-operative outcomes, but future research is required to inform their design. This review aimed to identify and synthesize recent literature on the content and delivery of pre-operative TKR interventions to help guide future research and clinical practice. METHODS: This rapid review included randomized trials of pre-operative TKR interventions ("outcomes studies") and primary studies exploring patients' and/or health professionals' views of pre-operative TKR interventions ("views studies"). Medline, Embase, PsycINFO, CINAHL and the Cochrane Central Register of Controlled Trials were searched for English language studies published between January 2009 and December 2020. Eligible studies' reference lists were screened. Studies were appraised using the Mixed Methods Appraisal Tool. The findings were narratively synthesized using a convergent segregated approach. RESULTS: From 3263 records identified, 52 studies were included (29 outcomes studies, 21 views studies, two outcomes/views studies). The studies' methodological quality varied but was generally highest in qualitative studies. The outcomes studies investigated education (n=5), exercise (n=20), psychological (n=2), lifestyle (n=1), and/or other interventions (n=5). The views studies addressed education (n=20), exercise (n=3), psychological (n=1), lifestyle (n=4), and/or other interventions (n=1). Only three outcomes studies (two randomized controlled trials (RCTs) and a pilot study) compared the effectiveness of intervention components/delivery approaches. The two RCTs' results suggest that pre-operative TKR exercise interventions are equally effective regardless of whether they include strength or strength plus balance training and whether they are hospital- or home-based. Personal tailoring and using more than one delivery format were associated with improved outcomes and/or perceived as beneficial for multiple intervention types. CONCLUSIONS: Definitive evidence on the optimal design of pre-operative TKR interventions is lacking. Personal tailoring and employing multiple delivery formats appear to be valuable design elements. Preliminary evidence suggests that including balance training and hospital versus home delivery may not be critical design elements for pre-operative TKR exercise interventions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019143248 FUNDER: National Institute for Health and Care Research (ICA-CDRF-2018-04-ST2-006).

Shifting responsibilities: A qualitative study of how young people assume responsibility from their parents for self-management of their chronic kidney disease.

INTRODUCTION: The responsibility for managing a long-term condition (LTC) such as chronic kidney disease (CKD) typically transfers from parent to child, as children become older. However, children can find it challenging to become independent at managing their LTC, and evidence for how healthcare professionals (HCPs) support transfer of responsibility is limited. This study aimed to explore how young people with CKD assume responsibility for managing their condition and the HCP's role during this process. METHODS: Sampling, qualitative data collection and analysis were guided by a constructivist grounded theory approach. Individual and dyadic interviews, and focus groups, were conducted with 16 young people aged 13-17 years with CKD, 13 parents and 20 HCPs. FINDINGS: A grounded theory, shifting responsibilities, was developed that provides new insights into how young people's, parents' and HCPs' constructions of the transfer of responsibility differed. These diverse constructions contributed to multiple uncertainties around the role of HCPs, when the process started and was completed and whether the endpoint of the process was young people's self-management or young person-parent shared management. CONCLUSION: Families would benefit from HCP support over a longer timeframe that integrates assuming self-management responsibility with gaining independence in other areas of their lives and focuses on young people 'doing' self-management. PATIENT OR PUBLIC CONTRIBUTION: Patient and public involvement was integrated throughout the study, with young adults with CKD and parents who had a child with CKD actively involved in the study's design and delivery.

The relationship between multisite peripheral joint pain and physical activity levels in older adults: A cross-sectional survey.

INTRODUCTION: Research on levels of physical activity (PA) in those with peripheral joint pain have only focused on single sites, in the knee or hips. This study investigated the levels of PA in adults with single-site and multisite peripheral joint pain compared to adults with no joint pain. METHODS: Analysis of a cross-sectional population survey mailed to adults aged ≥45 years (n = 28,443) was conducted. Respondents reported any peripheral joint pain in the last 12 months in either the hands, hips, knees or feet; PA levels were self-reported using the short telephone activity rating scale. The association between PA levels, peripheral joint pain and outcomes of health status (physical and mental component scores, using SF-12) pain intensity (10-point scale) and health-related quality of life (HRQoL) (EQ-5D) were investigated using analysis of variance and ordinal regressions. RESULTS: Compared to those with no joint pain, all pain groups reported lower levels of PA: joint pain in one site (odds ratio = 0.91, 95% CI: 0.83-0.99); two sites (0.74, 0.67-0.81), three sites (0.65, 0.59-0.72) and four sites (0.47, 0.42-0.53). Across all joint pain groups, levels of PA were associated with pain intensity, physical health status, mental health status and HRQoL. DISCUSSION: Adults with more sites of peripheral joint pain were more likely to report lower levels of PA. Those with more sites of pain and lower levels of PA reported poorer outcomes. Health care providers should be aware that those with multisite joint pain are most likely to have low levels of PA.

Understanding peer mentorship in supporting self-management of hip and knee osteoarthritis: A qualitative study of mentees' perspectives.

BACKGROUND: Hip and knee osteoarthritis (OA) are common musculoskeletal conditions. Treatment is usually conservative, making self-management a priority. We developed and trialled an OA peer mentorship intervention to support self-management in older people. Our objectives were to gain understanding of the perceived challenges of living with OA and explore how a peer mentorship intervention can support tackling these challenges; and to explore mentees' experiences of receiving the intervention to understand how this affected their OA self-management. METHODS: Qualitative semi-structured interviews focussing on acceptability and feasibility of being in the study were conducted with mentees. Transcribed interviews were double coded and subject to framework analysis. To address the objectives of this paper, three main themes were subject to focused analysis: mentees' experiences of OA, experience of peer mentorship support and factors influencing self-management. RESULTS: Seventeen mentees participated in an interview following completion of the peer support intervention. Themes emerging from focused analysis were the following: tackling the challenges of living with OA pre- and post-intervention; and the interplay of the peer mentorship intervention and self-management. Key elements of the latter theme are enabling factors provided by peer mentorship, and mentees' readiness to self-manage. CONCLUSION: To effectively support OA self-management, peer mentorship interventions should include core educational components and focus on strategies that enhance key enablers of self-management. Paying attention to the mentor-mentee relationship and timing of intervention engagement can maximise opportunities for older people to adjust and transition from supported to independent self-management.

Self-care support of diet and the gut in the routine care of school-age children with long-term conditions: An integrative review.

There is policy impetus for provision of self-care support (SCS) for children with long-term conditions (LTCs). However, it is not clear what SCS should consist of and how it can be delivered in routine care. This review aimed to synthesise the literature, specifically on SCS of diet and the gut as these components are essential for optimal growth and development and enhanced quality of life. Using an integrative review methodology, studies conducted between January 1990 and July 2020 were systematically identified and methodological quality assessed using the Mixed Methods Appraisal Tool. Twenty-five studies were included. SCS of diet and the gut consisted of support in developing and applying specific knowledge and skills and practical help with incorporating the demands of self-care into everyday life. Key requisites for models of SCS in the context of delivery and uptake in routine care were starting early, keeping it going, being flexible and choosing appropriate outcomes. This review contributes new understanding on the provision of SCS of diet and the gut for school-age children with LTCs, including identification of gaps in the literature and further research needs.

Exploring the feasibility, acceptability and value of volunteer peer mentors in supporting self-management of osteoarthritis: a qualitative evaluation.

BACKGROUND: Hip and knee osteoarthritis (OA) affect a large and growing proportion of the population. Treatment options are typically conservative making self-management a priority. Using trained peers to support individuals with OA has potential to improve self-management. PURPOSE: To explore the process of engaging and training volunteers to become peer mentors; and to qualitatively evaluate the feasibility, acceptability and value of being a peer mentor to support others' self-management of OA. MATERIALS AND METHODS: A qualitative evaluation of a peer mentorship support intervention reporting the processes of recruitment and training; and semi-structured interviews conducted with nine active peer mentors. Transcribed interviews were coded and analysed using framework analysis. RESULTS: It was possible to recruit, train and retain volunteers with OA to become peer mentors. The peer mentors benefitted from their training and felt equipped to deliver the intervention. They enjoyed social elements of the mentorship intervention and gained satisfaction through delivering valued support to mentees. Peer mentors perceived the mentorship intervention to have a positive impact on self-management of OA for mentees. CONCLUSION: Training volunteers with OA to become peer mentors was feasible and acceptable. Peer mentors perceived their support benefitted others with OA. They positively rated their experience of providing mentorship support.IMPLICATIONS FOR REHABILITATIONThis study demonstrates that it is possible to recruit, train and engage older volunteers to become peer mentors for people with osteoarthritis.Training should highlight the significance of employing key self-management techniques such as goal-setting.Peer mentors acknowledged that they benefitted from training and delivering the mentorship intervention, and this impacted positively on their own osteoarthritis self-management.Careful consideration of matching mentors and mentees appears to enhance the success of mentorship support.Recognising the impact of mentorship support on mentees' self-management is central to peer mentors' sustained engagement with the intervention.

Peer mentorship to improve self-management of hip and knee osteoarthritis: a randomised feasibility trial.

OBJECTIVE: To determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA). DESIGN: Six-month parallel group non-blinded randomised feasibility trial. SETTING: One secondary care and one primary care UK National Health Service Trust. PARTICIPANTS: Fifty adults aged ≥55 years old with hip and/or knee OA. INTERVENTIONS: Participants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only. OUTCOME MEASURES: Key feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months. RESULTS: Ninety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group. CONCLUSIONS: The feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures. TRIAL REGISTRATION NUMBER: ISRCTN:50675542.

Consensus on pre-operative total knee replacement education and prehabilitation recommendations: a UK-based modified Delphi study.

BACKGROUND: Over 90,000 total knee replacement (TKR) procedures are performed annually in the United Kingdom (UK). Patients awaiting TKR face long delays whilst enduring severe pain and functional limitations. Almost 20% of patients who undergo TKR are not satisfied post-operatively. Optimising pre-operative TKR education and prehabilitation could help improve patient outcomes pre- and post-operatively; however, current pre-operative TKR care varies widely. Definitive evidence on the optimal content and delivery of pre-operative TKR care is lacking. This study aimed to develop evidence- and consensus-based recommendations on pre-operative TKR education and prehabilitation. METHODS: A UK-based, three-round, online modified Delphi study was conducted with a 60-member expert panel. All panellists had experience of TKR services as patients (n = 30) or professionals (n = 30). Round 1 included initial recommendations developed from a mixed methods rapid review. Panellists rated the importance of each item on a five-point Likert scale. Panellists could also suggest additional items in Round 1. Rounds 2 and 3 included all items from Round 1, new items suggested in Round 1 and charts summarising panellists' importance ratings from the preceding round. Free-text responses were analysed using content analysis. Quantitative data were analysed descriptively. All items rated as 'Important' or 'Very important' by at least 70% of all respondents in Round 3 were included in the final set of recommendations. RESULTS: Fifty-five panellists (92%) (patients n = 26; professionals n = 29) completed Round 3. Eighty-six recommendation items were included in Round 1. Fifteen new items were added in Round 2. Rounds 2 and 3 therefore included 101 items. Seventy-seven of these reached consensus in Round 3. Six items reached consensus amongst patient or professional panellists only in Round 3. The final set of recommendations comprises 34 education topics, 18 education delivery approaches, 10 exercise types, 13 exercise delivery approaches and two other treatments. CONCLUSIONS: This modified Delphi study developed a comprehensive set of recommendations that represent a useful resource for guiding decision-making on the content and delivery of pre-operative TKR education and prehabilitation. The recommendations will need to be interpreted and reviewed periodically in light of emerging evidence.

Impact of Chronic Pain on Patients' Quality of Life: A Comparative Mixed-Methods Study.

BACKGROUND: Chronic pain has become a common problem within primary care and can negatively impact patients' lives. OBJECTIVE: To assess and explore the impact of chronic pain on patients' quality of life (QoL) using quantitative and qualitative data, respectively. METHODS: A convergent parallel mixed-methods design was used. Chronic pain patients were recruited from a community-based pain clinic located in the North of England. Quality of life was assessed using Short-Form 36 version 2. Quality of life data were also extracted from the Third Oxford and Lifestyles Survey and Welsh Health Survey to allow comparison of QoL of chronic pain patients with that of the general population and patients with long-term conditions. Qualitative interviews were conducted face-to-face using a semistructured topic guide. Quantitative data were analyzed using SPSS version 24 and qualitative data were analyzed thematically. RESULTS: Seventy-nine patients participated in the quantitative phase. The mean (standard deviation) age was 46.5 (14.5). Lower back (54; 68.3%) followed by lower limb were the most common pain sites. Compared with the general population and patients with long-term conditions, chronic pain patients had significantly lower mean QoL scores across all domains of SF-36 (All P < .05). Six themes emerged from qualitative data: interference with physical functioning, interference with professional life, interference with relationships and family life, interference with social life, interference with sleep, and interference with mood. CONCLUSION: The multidimensional negative impact of chronic pain leads to poorer QoL among patients with chronic pain compared to the general population and patients with other long-term conditions.

Identification and Evaluation of Self-Report Physical Activity Instruments in Adults With Osteoarthritis: A Systematic Review.

OBJECTIVE: To identify and evaluate the measurement properties of self-report physical activity instruments suitable for patients with osteoarthritis (OA). METHODS: We conducted a comprehensive 2-stage systematic review using multiple electronic databases, from inception until July 2018. In the stage 1 review, we sought to identify all self-report physical activity instruments used in individuals with joint pain attributable to OA in the foot, knee, hip, or hand. In the stage 2 review, we searched for and appraised studies investigating the measurement properties of the instruments identified. In both stages of the review, we screened all articles for study eligibility criteria, completed data extraction using the Qualitative Attributes and Measurement Properties of Physical Activity questionnaire checklist, and conducted methodology quality assessments using a modified COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist. Measurement properties for each physical activity instrument were evaluated and combined, using narrative synthesis. RESULTS: In the stage 1 review, we identified 23 unique self-report physical activity instruments. In the stage 2 review, we identified 54 studies that evaluated the measurement properties of 13 of the 23 instruments identified. Instrument reliability varied from inadequate to adequate (intraclass correlation coefficient ≥0.7). Instrument construct and criterion validity assessment showed small to moderate correlations with direct measures of physical activity. Instrument responsiveness was assessed in only 1 instrument and was unable to detect changes in comparison to accelerometers. CONCLUSION: Although many instruments were identified as being potentially suitable for use in patients with OA, none demonstrated adequate measurement properties across all domains of reliability, validity, and responsiveness. Further high-quality assessment of self-report physical activity instruments is required before such measures can be recommended for use in OA research.

Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review.

BACKGROUND: The quality of reporting of harms data in randomised controlled trials (RCTs) has been reported to be suboptimal. Rheumatoid arthritis (RA) has seen a massive growth in novel pharmacotherapies in the last decade. OBJECTIVE: The aim of this study was to assess the quality of reporting of harms-related data in RCTs evaluating pharmacological interventions for RA according to the CONSORT (Consolidated Standards of Reporting Trials) statement on harms reporting extension. STUDY SELECTION: RCTs published between January 2011 and August 2016 in the five highest impact factor journals in general medicine and two in rheumatology subject categories as per 2015 Journal Citation Reports were included. Reports of secondary, supplementary or exploratory analyses of RCTs and non-inferiority trials were excluded. Two reviewers independently extracted data using a structured, pilot-tested, 18-item questionnaire developed based on CONSORT harms extension recommendations. FINDINGS: 68 RCTs were included in the review. Out of a maximum harms reporting score of 18, the mean (SD) score was 8.51 (3.5) (range=0-15). More than half (56.5%) of the RCTs reported ≤50% of items and only three (4.3%) RCTs reported more than 70% (score ≥14) of the items. Multilinear regression analyses found that region of trial origin (p=0.01), sample size (p=0.001) and whether the study was a long-term extension of a trial or not (p=0.04) were independent predictors associated with higher total harms reporting score. CONCLUSIONS: The adherence to CONSORT harms extension was poor in recently published RCTs of pharmacological interventions for RA. There is a need to improve quality of harms reporting in RCTs to allow transparent and balanced assessment of the benefit-risk ratio in clinical decision making.

A nurse-led clinic for patients consulting with osteoarthritis in general practice: development and impact of training in a cluster randomised controlled trial.

BACKGROUND: Despite a lack of service provision for people with osteoarthritis (OA), each year 1 in 5 of the general population consults a GP about a musculoskeletal condition such as OA. Consequently this may provide an opportunity for practice nurses to take an active role in helping patients manage their condition. A nurse led clinic for supporting patients with OA was developed for the MOSAICS study investigating how to implement the NICE 2014 OA Guideline core recommendations. This paper has two main objectives, firstly to provide an overview of the nurse-led OA clinic, and secondly to describe the development, key learning objectives, content and impact of the training to support its delivery. METHODS: A training programme was developed and delivered to provide practice nurses with the knowledge and skill set needed to run the nurse-led OA clinic. The impact of the training programme on knowledge, confidence and OA management was evaluated using case report forms and pre and post training questionnaires. RESULTS: The pre-training questionnaire identified a gap between what practice nurses feel they can do and what they should be doing in line with NICE OA guidelines. Evaluation of the training suggests that it enabled practice nurses to feel more knowledgeable and confident in supporting patients to manage their OA and this was reflected in the clinical management patients received in the nurse-led OA clinics. CONCLUSIONS: A significant gap between what is recommended and what practice nurses feel they can currently provide in terms of OA management was evident. The development of a nurse training programme goes some way to develop a system in primary care for delivering the core recommendations by NICE. TRIAL REGISTRATION: The cluster trial linked to this training was conducted from May 2012 through February 2014 by the Arthritis Research UK Primary Care Centre, Keele University, UK (Trial registration number ISRCTN06984617 ).

Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol.

BACKGROUND: There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving 'quality markers' of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain. DESIGN: A mixed methods study with a nested cluster randomised controlled trial. METHOD: This study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive 'whole-system' evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations. DISCUSSION: The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance. TRIAL REGISTRATION: ISRCTN number: ISRCTN06984617.

Individuals' expectations and challenges following total hip replacement: a qualitative study.

PURPOSE: Hip replacements are one of the most common operations for individuals with hip osteoarthritis. There have been numerous quantitative studies investigating the recovery from joint replacement surgery and these show how effective and satisfied patients are. However, little qualitative work has been conducted to explore patients' actual experiences. Therefore, this study aimed to detail the experiences of individuals undergoing a total hip replacement (THR) to determine whether their expectations were met. METHOD: The qualitative study was nested within a longitudinal study (n = 215) that was investigating biomedical and psychosocial outcomes from THR. We interviewed a purposive sample of individuals (n = 25) 6 months after THR to explore their experiences of having a THR. FINDINGS: Participants were aged 48-82 years. They felt disabled following the THR and some had unrealistic expectations of recovery. Most of them received minimal information and health professional support. Participants had to overcome a number of challenges such as diminished confidence, frustration over slow progress and reduced physical functioning. CONCLUSION: Individuals undergoing THR need to have the opportunity to discuss their expectations of THR, so there is no "false optimism". Support requirements, following THR, need to be reviewed as they were often underestimated by patients and health professionals.