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Objectives To compare health-related quality of life (HRQoL) before and after treatment with etanercept in patients with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and psoriasis using spydergram representations. Methods Data from randomised, controlled trials of etanercept in patients with RA, PsA and psoriasis were analysed. HRQoL was assessed by the medical outcomes survey short form 36 (SF-36) physical (PCS) and mental (MCS) component summary and domain scores. Baseline comparisons with age and gender-matched norms and treatment-associated changes in domain scores were quantified using spydergrams and the health utility SF-6D measure. Results Mean baseline PCS scores were lower than age and gender-matched norms in patients with RA and PsA, but near normative values in patients with psoriasis; MCS scores at baseline were near normal in PsA and psoriasis but low in RA. Treatment with etanercept resulted in improvements in PCS and MCS scores as well as individual SF-36 domains across all indications. Mean baseline SF-6D scores were higher in psoriasis than in RA or PsA; clinically meaningful improvements in SF-6D were observed in all three patient populations following treatment with etanercept. Conclusions Patients with RA, PsA and psoriasis demonstrated unique HRQoL profiles at baseline. Treatment with etanercept was associated with improvements in PCS and MCS scores as well as individual domain scores in patients with RA, PsA and psoriasis.

Background Patients newly diagnosed with inflammatory arthritis (IA) often face substantial physical, psychological, and social challenges despite advances in pharmacological management. Objective To investigate the efficacy of the “Newly diagnosed with Inflammatory arthritis—a Self-MAnagement intervention” (NISMA) and usual care, compared to usual care alone (control group), in adults with newly diagnosed IA. Methods This pragmatic, multicenter randomized controlled trial (RCT) will enroll 130 adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) recruited consecutively from three Danish hospitals and randomized 1:1 to NISMA plus usual care or usual care alone. The control group receives usual care, which consists of planned consultations with a rheumatologist and access to nurses. NISMA comprises three mandatory individual nurse-led sessions with two optional multidisciplinary group sessions delivered over 12 months. Assessments occur at baseline, 12 months (primary), and 24 months (extension). The primary outcome is the Health Education Impact Questionnaire (heiQ) “skill and technique acquisition” domain. Statistical analysis Analyses follow the intention-to-treat principle. For the primary analysis, analysis of covariance (ANCOVA) adjusted for baseline, center, and diagnosis will estimate between-group differences with two-sided 95% CIs. Model assumptions (normality, homoscedasticity) will be checked (Q–Q plots, residual diagnostics). If violated, pre-specified alternatives (e.g., transformation, rank-based ANCOVA, or nonparametric tests) will be used. Missing data will be addressed using multiple imputation. Key secondary endpoints will be assessed in a pre-specified hierarchical (gatekeeping) order; any post hoc analyses will be exploratory. Extension analyses at 24 months will use linear mixed-effects models. Discussion This randomized controlled trial will provide essential insights about the efficacy of a targeted self-management intervention for newly diagnosed patients with inflammatory arthritis. If successful, the NISMA intervention could significantly enhance non-pharmacological management, providing a comprehensive approach to addressing both physical and psychological needs in caring for patients newly diagnosed with IA. Trial registration {2b} ClinicalTrials.gov, nr.: NCT06533423. Registered on December 19, 2024. Protocol version {3} 22.09.2025. Version 2.

Background Osteoarthritis (OA) often leads to pain and functional limitations, impacting work and daily life. Physical activity (PA) is an important part of the treatment. Wearable activity trackers (WATs) offer a novel approach to promote PA but could also aid in finding a sustainable PA level over time. The aim of this secondary analysis was to examine the effects of self-monitoring PA with a WAT on perceived joint function and health-related quality of life in people with hip and knee OA. Method A two-armed cluster-randomized controlled trial (C-RCT) was conducted in southern Sweden including 160 individuals with hip or knee OA. The participants were cluster-randomized to a Supported Osteoarthritis Self-management Program (SOASP) with the addition of self-monitoring PA using a commercial WAT for 12 weeks (n = 86), or only the SOASP ( n  = 74). The outcomes include perceived joint function measured with HOOS/KOOS and health-related quality of Life (HRQoL) measured with EQ-5D-3L index and EQ VAS. Participants responded to the questionnaires at baseline and at follow-up after 3, 6 and 12 months. Statistical analyses involved linear mixed models, ANCOVA and paired t-test. Results Participants with data from baseline and at least one follow-up were included in the analyses ( n  = 124). The analyses showed no statistically significant differences in changes between the groups in perceived joint function or HRQoL throughout the study period. Both groups improved in pain and symptoms, but the changes were small. Conclusion The addition of WAT-use did not have any effect on perceived joint function or HRQoL. The participants’ relatively high baseline scores might have influenced the outcomes of this study. We suggest that future WAT-interventions target inactive people with OA and use devices that also captures other activities such as cycling or aquatic exercise. Trial registration ClinicalTrials.gov, NCT03354091. Registered 15/11/2017.

To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international recommendations. The objective of this study was to assess the effectiveness of this model in primary care. We conducted a cluster-randomised controlled trial with stepped-wedge cohort design in 6 Norwegian municipalities (clusters) between January 2015 and October 2017. The randomised order was concealed to the clusters until the time of crossover from the control to the intervention phase. The intervention was implementation of the SAMBA model, facilitated by interactive workshops for general practitioners and physiotherapists with an update on OA treatment recommendations. Patients in the intervention group attended a physiotherapist-led OA education and individually tailored exercise programme for 8-12 weeks. The primary outcome was patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire; 0-100, 100 = optimal quality) at 6 months. Secondary outcomes included patient-reported referrals to physiotherapy, magnetic resonance imaging (MRI), and orthopaedic surgeon consultation; patients' satisfaction with care; physical activity level; and proportion of patients who were overweight or obese (body mass index ≥ 25 kg/m2). In all, 40 of 80 general practitioners (mean age [SD] 50 [12] years, 42% females) and 37 of 64 physiotherapists (mean age [SD] 42 [8] years, 65% females) participated. They identified 531 patients, of which 393 patients (mean age [SD] 64 [10] years, 71% females) with symptomatic hip or knee OA were included. Among these, 109 patients were recruited during the control periods (control group), and 284 patients were recruited during interventions periods (intervention group). The patients in the intervention group reported significantly higher quality of care (score of 60 versus 41, mean difference 18.9; 95% CI 12.7, 25.1; p < 0.001) and higher satisfaction with OA care (odds ratio [OR] 12.1; 95% CI 6.44, 22.72; p < 0.001) compared to patients in the control group. The increase in quality of care was close to, but below, the pre-specified minimal important change. In the intervention group, a higher proportion was referred to physiotherapy (OR 2.5; 95% CI 1.08, 5.73; p = 0.03), a higher proportion fulfilled physical activity recommendations (OR 9.3; 95% CI 2.87, 30.37; p < 0.001), and a lower proportion was referred to an orthopaedic surgeon (OR 0.3; 95% CI 0.08, 0.80; p = 0.02), as compared to the control group. There were no significant group differences regarding referral to MRI (OR 0.6; 95% CI 0.13, 2.38; p = 0.42) and proportion of patients who were overweight or obese (OR 1.3; 95% CI 0.70, 2.51; p = 0.34). Study limitations include the imbalance in patient group size, which may have been due to an increased attention to OA patients among the health professionals during the intervention phase, and a potential recruitment bias as the patient participants were identified by their health professionals. In this study, a structured model in primary care resulted in higher quality of OA care as compared to usual care. Future studies should explore ways to implement the structured model for integrated OA care on a larger scale. ClinicalTrials.gov NCT02333656.

Background Osteoarthritis (OA) is a joint disease with a high worldwide prevalence, often leading to replacement surgery. However, despite the high success rate of replacement surgery, some patients fail to experience the intended benefits. Given the importance of patient involvement, this trial aims to assess the effect of shared decision-making (SDM) on decisional quality for patients with severe OA. Specifically, it investigates whether an in-consult patient decision aid (PtDA) enhances decisional quality, involvement, and health outcomes for patients with severe hip or knee OA. Methods This protocol outlines a pragmatic two-armed multicentre cluster-randomised controlled trial (C-RCT), chosen for its ability to assess the combined effect of shared decision-making (SDM) and a newly developed in-consult patient decision aid (PtDA) in routine clinical practice. The PtDA is a tool designed to help patients make informed decisions during the consultation by providing personalised treatment options, benefits, and risks. The C-RCT design is particularly well-suited to this context, as it effectively minimises contamination and bias across treatment groups. A total of 19 orthopaedic surgeons will be randomised 1:1, stratified by centre, to either continue standard consultations without the PtDA or implement SDM using the PtDA. The trial will recruit 615 patients with severe hip or knee OA. Outcomes will be measured at one week, three months, and 12 months post treatment start. The primary outcome, decisional quality, will be assessed using the Hip/Knee OA Decision Quality Instrument, focusing on patients being well-informed and receiving their preferred treatment. The secondary outcomes include patient involvement in the decision-making process and consultation durations. The tertiary outcomes include patients’ satisfaction, regret and health-related outcomes. The primary outcome will be analysed using a multilevel mixed-effects logistic regression with surgeons as random effects reporting odds ratios with 95% confidence intervals. Discussion This study aims to contribute insights into the use of SDM facilitated by a PtDA and its impact on improving decisional quality for future patients with hip or knee OA. Trial registration www.ClinicalTrials.gov (NCT05972525), Data of registration: 06.08.2023.

OBJECTIVE:The aim of this study was to evaluate the effectiveness of a 12-week workplace exercise program on work ability, performance, and patient-reported symptoms in older university employees with knee and/or hip osteoarthritis. METHODS:Twenty-four participants with clinical hip and/or knee osteoarthritis were randomized to exercise or no exercise. At baseline and follow-up, several work (work ability, resilience), patient-reported (pain, physical function, depressive symptoms, self-efficacy), and performance outcomes (hip and knee strength, mobility performance) were measured. RESULTS:Significant improvements in work ability (P < 0.049) and patient-reported outcomes (pain, function, depressive symptoms) existed in the exercise group. No improvements were demonstrated in the no exercise group. CONCLUSIONS:Exercise in the workplace improved work ability and patient-reported symptoms in older workers with osteoarthritis. The benefits of workplace exercise programs should be studied in a larger sample in which attention is given to improving exercise adherence.

This study aims to investigate the association between mental health and quality of life of osteoarthritis (OA) patients according to the site of pain. Retrospective cross-sectional study. Data of 22,948 participants of the sixth Korea National Health and Nutrition Examination Survey conducted from 2013-2015 were used. Participants were asked if they had OA pain in the hip joint, knee joint, and lower back (yes/no) and whether they experienced anxiety or depression. The EQ-5D questionnaire was used to determine the quality of life of patients with hip, knee, and lower back OA. Multiple logistic regression analysis was performed after adjusting. A total of 5,401 patients reported pain in the hip joint, knee joint, or lower back. The analysis showed significant relations between pain sites, mental health, and quality of life. First, more female patients with OA experienced stress and depression than males. Second, for males with OA, stress was reported in the order of: lower back > hip > knee, while pain and depression was reported in the order of: lower back > knee > hip (p < 0.05). For females with OA, stress was reported in the order of: knee > lower back > hip, while depression was reported in the order of: knee > lower back > hip. Third, considering quality of life, for males, hip joint pain had the greatest impact on quality of life and for females, knee joint pain had the largest impact (p < 0.001). For patients with OA, the effect on the mental health and quality of life differed according to sex and sites of pain. Therefore, this study confirms that pain sites, sex, mental health, and quality of life are independent risk factors when determining OA pain.

Background Four out of five people living with osteoarthritis (OA) also suffer with at least one other long-term health condition. The complex interaction between OA and multiple long-term conditions (MLTCs) can result in difficulties with self-care, restricted mobility, pain, anxiety, depression and reduced quality of life. The aim of the MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE) trial is to evaluate the clinical and cost-effectiveness of the Living Well self-management support intervention, co-designed with people living with OA, integrated into usual care, in comparison to usual care alone. Methods TIPTOE is a multi-centre, two-arm, individually randomised controlled trial where 824 individuals over 65 years old with knee and/or hip joint pain from their OA affected joint and at least one other long-term health condition will be randomised to receive either the Living Well Self-Management support intervention or usual care. Eligible participants can self-refer onto the trial via a website or be referred via NHS services across Wales and England. Those randomised to receive the Living Well support intervention will be offered up to six one-to-one coaching sessions with a TIPTOE-trained healthcare practitioner and a co-designed book. Participants will be encouraged to nominate a support person to assist them throughout the study. All participants will complete a series of self-reported outcome measures at baseline and 6- and 12-month follow-up. The primary outcome is symptoms and quality of life as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ). Routine data will be used to evaluate health resource use. A mixed methods process evaluation will be conducted alongside the trial to inform future implementation should the TIPTOE intervention be found both clinically and cost-effective. An embedded ‘Study Within A Project’ (SWAP) will explore and address barriers to the inclusion of under-served patient groups (e.g. oldest old, low socioeconomic groups, ethnic groups). Discussion TIPTOE will evaluate the clinical and cost-effectiveness of a co-designed, living well personalised self-management support intervention for older individuals with knee and/or hip OA and MLTCs. The trial has been designed to maximise inclusivity and access. Trial registration ISRCTN 16024745 . Registered on October 16, 2023.

Background The Pain Coping S kills T raining for A frican A mericans with Osteoa RT thritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA. Methods A literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities’ Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies. Results The mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61–86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62–66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m 2 (SD = 8.2), was higher than all other studies (30–34 kg/m 2 ). STAART participants’ mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7–17). Conclusions Compared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants’ high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach. Trial registration NCT02560922

Background To determine if the EuroQol Health Related Quality of Life survey produces equivalent results when administered by phone interview or patient-completed forms. Methods People awaiting hip or knee arthroplasty at a major metropolitan hospital participated. They were randomly assigned to receive the EuroQol Health Related Quality of Life survey via telephone, followed by a patient completed form 1 week later, or vice versa. Equivalence was determined using two one-sided tests (TOST) based on minimal clinically-important differences for the visual analogue scale (VAS) and the summary Utility Index. Cohen’s Kappa scores were computed to determine agreement for the individual EuroQoL Likert scale items. Results Seventy-six from 90 (84%) participants completed the survey twice. Based on limits set at ±7 and ±0.11 for the VAS and Utility Index, respectively, equivalence was established between the two methods of administration for both the VAS (mean difference 0.05 [90% CI −3.76–3.67]) and the Utility Index (mean difference 0.06 [90% CI 0.02–0.11]). Varying levels of agreement, ranging from slight to substantial (κ = 0.17–0.67), were demonstrated for the individual health domains. The order of telephone and patient-completed survey administration had no significant effect on results. Conclusions Equivalent results are obtained between telephone and patient-completed administration for the VAS and Utility Index of the EuroQol Survey in people with advanced hip or knee osteoarthritis. The limits of agreement for the individual health domains vary which prevents the accurate interpretation of real change in these items across modes.