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ObjectivesTo evaluate fidelity of delivery of a nurse-led non-pharmacological complex intervention for knee pain.SettingSecondary care. Single-centre study.Study designMixed methods study.ParticipantsEighteen adults with chronic knee pain.Inclusion criteriaAge >40 years, knee pain present for longer than 3 months, knee pain for most days of the previous month, at least moderate pain in two of the five domains of Western Ontario and McMaster Universities Osteoarthritis Index pain scale.InterventionsNurse-led non-pharmacological intervention comprising assessment, education, exercise, use of hot/cold treatments, footwear modification, walking aids and weight-loss advice (if required).Outcome(s)Primary: fidelity of delivery of intervention, secondary: nurses’ experience of delivering intervention.MethodsEach intervention session with every participant was video recorded and formed part of fidelity assessment. Fidelity checklists were completed by the research nurse after each session and by an independent researcher, after viewing the video-recordings blinded to nurse ratings. Fidelity scores (%), percentage agreement and 95% Confidence Intervals (CI) were calculated. Two semi-structured interviews were conducted with the research nurse.ResultsFourteen participants completed all visits. 62 treatment sessions took place. Nurse self-report and assessor video rating scores for all 62 treatment sessions were included in fidelity assessment. Overall fidelity was higher on nurse self-report (97.7%) than on objective video-rating (84.2%). Percentage agreement between nurse self-report and video-rating was 73.3% (95% CI 71.3 to 75.3). Fidelity was lowest for advice on footwear and walking aids. The nurse reported difficulty advising on thermal treatments, footwear and walking aids, and did not feel confident negotiating achievable and realistic goals with participants.ConclusionsA trained research nurse can deliver most components of a non-pharmacological intervention for knee pain to a high degree of fidelity. Future research should assess intervention fidelity in a routine clinical setting, and examine its clinical and cost-effectiveness.Trial registration numberNCT03670706.

Introduction: Although calcium pyrophosphate deposition (CPPD) disease is common, there are no validated outcome measures for clinical research in this condition. The aim of this study was to generate a list of outcome domains as reported by patients, their caregivers, healthcare professionals (HCPs) and stakeholders to inform the development of an Outcome Measures in Rheumatology (OMERACT) Core Domain Set for CPPD. Methods: Patients with CPPD and their caregivers, HCPs and stakeholders took part in semi-structured qualitative interviews to explore potential outcome domains for CPPD clinical research relevant to their lived experience and knowledge of CPPD. Interviews were conducted in six countries across three continents. Data was analysed using manifest content analysis to identify outcome domains, which were tabulated and mapped to the core areas as defined by the OMERACT Filter 2.1. Results: Thirty-six interviews were conducted in total. Participants comprised of 28 patients (six of which included a caregiver), seven HCPs and one stakeholder. The commonly identified (sub-) domains (d) across the 1) abnormalities/manifestations core area were joint pain (d = 35), joint swelling (d = 27), joint stiffness (d = 25), CPPD flares (d = 25); 2) life-impact core area were overall function (d=35), and specifically the ability to complete daily tasks (d = 25); and 3) societal/resource use core area were use of analgesic medicines (d = 26). Patients more commonly reported joint swelling, stiffness and range of movement, and use of analgesics while HCPs more commonly reported domains relating to presence of CPP crystals, radiologic calcification, joint damage, time to diagnosis and suitability of treatment. Conclusion: Among a number of potential outcome domains identified, articular manifestations, function and analgesic use were most frequently mentioned by participants. These findings will be used to develop an OMERACT Core Domain Set for CPPD. (C) 2021 Elsevier Inc. All rights reserved.

ObjectivesThe overall purpose of this research programme is to develop and test the feasibility of a complex intervention for knee pain delivered by a nurse, and comprising both non-pharmacological and pharmacological interventions. In this first phase, we examined the acceptability of the non-pharmacological component of the intervention, issues faced in delivery, and resolve possible challenges.MethodsEighteen adults with chronic knee pain were recruited from the community. The intervention comprised holistic assessment, education, exercise, weight-loss advice (where appropriate) and advice on adjunctive treatments such as hot/cold treatments, footwear modification and walking aids. After nurse training, the intervention was delivered in four sessions spread over five weeks. Participants had one to one semi-structured interview at the end of the intervention. The nurse was interviewed after the last visit of the last participant. These were audio recorded and transcribed verbatim. Themes were identified by one author through framework analysis of the transcripts, and cross-checked by another.ResultsMost participants found the advice from the nurse easy to follow and were satisfied with the package, though some felt that too much information was provided too soon. The intervention changed their perception of managing knee pain, learning that it can be improved with self-management. However, participants thought that the most challenging part of the intervention was fitting the exercise regime into their daily routine. The nurse found discussion of goal setting to be challenging.ConclusionThe nurse-led package of care is acceptable within a research setting. The results are promising and will be applied in a feasibility randomised-controlled trial.

IntroductionKnee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.Methods and analysisIn phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.Ethics and disseminationThis protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.Trial registration numberNCT03670706

Introduction Although calcium pyrophosphate deposition (CPPD) is common, there are no validated outcome domains and/or measurements for CPPD studies. The aim of this work was to identify domains that have been reported in prior clinical studies in CPPD, to inform the development of a core set of domains for CPPD studies. Methods We performed a scoping literature review for clinical studies in CPPD, searching in Medline (via PubMed), EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases; published from January 1, 1946 to January 7, 2020. All reported outcomes and study design data were extracted and mapped to the core areas and domains as defined by the OMERACT Filter 2.1.The protocol was registered on PROSPERO (CRD: 42019137075; 09-07-2019). Findings There were 112 papers identified, comprising of 109 observational studies and three randomized controlled trials. Most studies reported clinical presentations of OA with CPPD or acute CPP crystal arthritis. Outcomes that mapped to 22 domains were identified; the most frequently reported measures mapped to the following domains/sub-domains: imaging (joint damage on imaging tests - 59 studies; joint calcification on imaging tests - 28 studies), joint pain (26 studies), response to treatment (23 studies), side effects of treatment (15 studies), inflammation in the joint fluid or blood (ESR or C-reactive protein - 12 studies; synovial fluid markers - 4 studies; other blood markers - 2 studies), overall function (14 studies), joint swelling (12 studies) and range of joint movement (10 studies). Very few studies mapped to domains related to life impact, societal/resource use or longevity. Conclusion There is substantial variability in outcomes reported in CPPD studies. Outcomes that map to imaging manifestations, joint pain and response to treatment domains are most often reported.

Background:The role of nurses in managing painful knee OA has been advocated but whether nurses can deliver such interventions as a package of care is unknown.The overall aim of this research is to develop and test a nurse-led complex intervention for knee pain comprising non-pharmacological and pharmacological components. In the first study phase, we report on fidelity and acceptability of a non-pharmacological intervention, to resolve possible challenges to delivery.Objectives:To evaluate fidelity of delivery and acceptability of non-pharmacological components of a complex intervention.Methods:This was a mixed-methods study. Participants with chronic knee pain were recruited from the community to receive the intervention, delivered in 4-sessions over a 5-week period by a trained research nurse. The intervention consisted of holistic assessment, patient education and advice, aerobic and strengthening exercise and weight-loss advice if required. All sessions were video-recorded. Fidelity checklists were completed by the nurse (nurse-rated) and two researchers from the video-recordings (video-rated). Median fidelity scores (%) and interquartile ranges (IQR) were calculated for each component and each session. Semi-structured interviews were conducted with participants. These were audio recorded, transcribed and analysed following the framework approach.Results:18 participants (34% women), with a mean (SD) age and BMI of 68.7 (9.0) years and 31.2 (8.4) kg/m2, took part in the study. Of these, 14 completed all visits. In total, 62 intervention sessions were assessed for fidelity. Overall fidelity was rated high by both nurse-rated scores (97.7%) and video-rated scores (84.2%). The level of agreement between nurse-rated and video-recorded methods was 73.3% (CI 71.3, 75.3) and the inter-rater agreement was 65.5% (CI 60.3, 70.5). Fidelity of delivery was lower for advice on footwear modification and walking aids in all sessions and moderate for education in session 1 and for exercise in session 4 (Table 1).Table 1.Fidelity scores of the components of the intervention for each session,Intervention componentsSession 1*Session 2*Session 3*Session 4*Education78.1 (74.1, 93.7)87.5 (50, 100)87.5 (50, 100)100 (93.7, 100)Exercise94.4 (88.9, 100)88.9 (75, 94)86.1 (72, 100)75 (67.6, 82.8)Adjunctive treatments50 (45.83, 100)0 (0, 50)50 (0, 100)-*median (IQR)17 participants were interviewed. Most found advice supplied straightforward. They were satisfied with the package, which changed their perception of managing knee pain, understanding it can be improved though self-management. However, too much information was provided in a short time-span and it was difficult to fit exercises into their daily routine.Conclusion:Delivery of a non-pharmacological intevention by a nurse is feasible within a research setting. Most components of the intervention were delivered as intended, except for advice about the use of adjunctive treatment.Acknowledgments:This research was funded by the NIHR Nottingham BRC and Pain Centre Versus ArthritisDisclosure of Interests:Polykarpos Angelos Nomikos: None declared, Amy Fuller: None declared, Michelle Hall: None declared, Bonnie Millar: None declared, Reuben Ogollah: None declared, Michael Doherty: None declared, Roshan Nair Speakers bureau: Financial support from pharmaceutical companies (Biogen and Novartis) to present lectures at events related to psychological support for people with multiple sclerosis (Speaker’s bureau)., David Walsh Grant/research support from: 2016: Investigator-led grant from Pfizer Ltd (ICRP) on Pain Phenotypes in RA; non-personal financial disclosure (payment to University)., Consultant of: DAW has undertaken paid consultancy to Pfizer Ltd, Eli Lilly and Company and GSK Consumer Healthcare., Paid instructor for: 2019: Consultancy to Love Productions; consultancy on programme design, contribution to programme content on self-management of chronic pain (payments to University)2019: Consultancy to AbbVie Ltd; 13.06.19; presentation on RA pain at EULAR, Madrid, and webinar (payments to University).2019: Consultancy to Eli Lilly and Company Ltd. 06.06.19 Centre for Collaborative Neuroscience, Windlesham, Surrey, UK (payment to University).2019: Consultancy to Pfizer (payment to University).2018: Consultancy to Pfizer. 07.12.18. USA. 1 day. Tanezumab (payment to University).2018: Consultancy to Pfizer. 23.11.18. Manchester UK. 1 day. Tanezumab (payment to University).2018: Consultancy to Pfizer. 1.11.18. Skype. 4h. Tanezumab (payment to University).2018: Consultancy to GlaxoSmithKline Plc. 1 day. Pain in RA and anti-GM-CSF (payment to University).2018: Consultancy to Pfizer Ltd; Presentation at OARSI; non-personal financial disclosure (payment to University)2018: Consultancy to Pfizer Ltd; Patient preference study; non-personal financial disclosure (payment to University)2017: Consultancy to Pfizer Ltd; personal financial disclosure2017: Consultancy to Pfizer Ltd through Nottingham University; non-personal financial disclosure (payment to University).2015: Consultancy to GSK Consumer Healthcare; personal financial disclosure., Speakers bureau: 2019: Irish Society of Rheumatology: speaker fees (personal pecuniary), Ana Valdes Grant/research support from: Awarded a grant from Pfizer, Abhishek Abhishek: None declared

Objectives: Chronic pelvic pain is the third most frequently cited indication for hysterectomy in the United States. The purpose of the present study was to investigate the relationship between prior hysterectomy and somatization in 155 consecutive referrals to a multidisciplinary chronic pelvic pain clinic at the University of Iowa. Study Design: All subjects completed a baseline evaluation assessing pain and medical history, demographic variables, abuse history, and family history of chronic pain. All subjects also completed the Beck Depression Inventory (BDI), the West Haven Yale Multi-Dimensional Pain Inventory (WHYMPI), the Locke-Wallace Marital Adjustment Scale, a previously validated somatization check-list, and an open-ended experimental item assessing attributions of pain causality. Thirty (20%) of the referrals who had previously undergone hysterectomy with or without bilateral salpingooophorectomy prior to referral to the clinic (study group) were compared with 125 subjects who had uteri and at least one adnexa in situ (controls). All dichotomous comparisons and tests for trends used a x2, 1 test, or Fisher’s exact test as appropriate. Results: Women who had undergone previous hysterectomy were found to be significantly older than women in the control group. Somatization scores were significantly higher among women in the study group as compared with controls. In addition, women who had undergone hysterectomy were significantly more likely to attribute their pain to occult somatic conditions (gynecological or other medical) than were control subjects. No differences were observed in demographic variables, spouse responses or marital adjustment, mood, severity or duration of pain, perceived control, physical or sexual abuse histories, or functional status between women in the study and control groups. Conclusions: These data suggest that hysterectomy may be regarded as a possible outcome of somatization and somatic causal pain attributions. They should serve to alert clinicians to women who may be at increased risk for atypical health care seeking behaviors, including surgery-seeking. They also emphasize the importance of comprehensive, multidisciplinary evaluation in women with chronic pelvic pain and women in whom hysterectomy is being considered in particular .