Longer-term quality of care, effectiveness, and cost-effectiveness of implementing a model of care for osteoarthritis: A cluster-randomized controlled trial.

OBJECTIVE: To assess the quality of care, effectiveness, and cost-effectiveness over 12 months after implementing a structured model of care for hip and knee osteoarthritis (OA) in primary healthcare as compared to usual care. DESIGN: In this pragmatic cluster-randomized, controlled trial with a stepped-wedge cohort design, we recruited 40 general practitioners (GPs), 37 physiotherapists (PTs), and 393 patients with symptomatic hip or knee OA from six municipalities (clusters) in Norway. The model included the delivery of a 3-hour patient education and 8-12 weeks individually tailored exercise programs, and interactive workshops for GPs and PTs. At 12 months, the patient-reported quality of care was assessed by the OsteoArthritis Quality Indicator questionnaire (16 items, pass rate 0-100%, 100%=best). Costs were obtained from patient-reported and national register data. Cost-effectiveness at the healthcare perspective was evaluated using incremental net monetary benefit (INMB). RESULTS: Of 393 patients, 109 were recruited during the control periods (control group) and 284 were recruited during interventions periods (intervention group). At 12 months the intervention group reported statistically significant higher quality of care compared to the control group (59% vs. 40%; mean difference: 17.6 (95% confidence interval [CI] 11.1, 24.0)). Cost-effectiveness analyses showed that the model of care resulted in quality-adjusted life-years gained and cost-savings compared to usual care with mean INMB €2020 (95% CI 611, 3492) over 12 months. CONCLUSIONS: This study showed that implementing the model of care for OA in primary healthcare, improved quality of care and showed cost-effectiveness over 12 months compared to usual care. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02333656.

Adherence to a Web-based Exercise Programme: A Feasibility Study Among Patients with Hip or Knee Osteoarthritis.

OBJECTIVES: To describe adherence to a 12-week web-based aerobic exercise programme, to compare characteristics between those who adhere or not, and to identify barriers for exercising in patients with hip or knee osteoarthritis. DESIGN: Single-arm feasibility study. SUBJECTS: Patients with hip or knee osteoarthritis in specialist healthcare, age 40-80 years, and not candidates for joint surgery. METHODS: Adherence to a 12-week exercise programme was defined as having completed ≥ 2 exercise sessions a week for at least 8 weeks. Baseline differences between adherent and non-adherent groups in demographics, symptoms, disability, physical activity and fitness were assessed using Mann-Whitney U or χ2 tests. Reasons for not completing exercise sessions were reported in weekly diaries.  Results: A total of 29 patients (median age 64 years, 72% female) were included. Median baseline pain (numerical rating scale 0-10) was 5. Fifteen patients adhered to the exercise programme, 14 did not. Non-adherent patients were less active (p = 0.032) and had lower cardiorespiratory fitness (p = 0.031). The most frequently reported barrier to exercising was sickness. Less than 10% reported pain as a barrier. CONCLUSION: Half of the patients with hip or knee osteoarthritis adhered to the digitally delivered exercise programme and the most frequently reported barrier for adherence was sickness, while less than 10% reported pain as a reason for not exercising. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04084834. The Regional Committee for Medical and Health Research Ethics South-East, 2018/2198.

The AktiWeb study: feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis.

BACKGROUND: Patient organisations may be an under-utilised resource in follow-up of patients requiring long-term exercise as part of their disease management. The purpose of this study was to explore the feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis (OA). METHODS: In this pre-post feasibility study, patients aged 40-80 years with hip and/or knee OA were recruited from Diakonhjemmet Hospital. The 12-week intervention was delivered through a patient organisation's digital platform. Feasibility was evaluated by proportion of eligible patients enrolled, proportion of enrolled patients who provided valid accelerometer data at baseline, and proportion completing the cardiorespiratory exercise test according to protocol at baseline and completed follow-up assessments. Patient acceptability was evaluated for website usability, satisfaction with the initial exercise level and comprehensibility of the exercise program. Change in clinical outcomes were assessed for physical activity, cardiorespiratory fitness and patient-reported variables. RESULTS: In total, 49 eligible patients were identified and 35 were enrolled. Thirty (86%) of these attended baseline assessments and provided valid accelerometer data and 18 (51%) completed the maximal cardiorespiratory exercise test according to protocol. Twenty-two (63%) patients completed the follow-up questionnaire, and they rated the website usability as 'acceptable' [median 77.5 out of 100 (IQR 56.9, 85.6)], 19 (86%) reported that the initial exercise level was 'just right' and 18 (82%) that the exercise program was 'very easy' or 'quite easy' to comprehend. Improvement in both moderate to vigorous physical activity (mean change 16.4 min/day; 95% CI 6.9 to 25.9) and cardiorespiratory fitness, VO2peak (mean change 1.83 ml/kg/min; 95% CI 0.29 to 3.36) were found in a subgroup of 8 patients completing these tests. Across all patient-reported outcomes 24-52% of the patients had a meaningful improvement (n = 22). CONCLUSION: A web-based exercise program delivered by a patient organisation was found to be feasible and acceptable in patients with hip and/or knee OA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04084834 (registered 10 September 2019). The Regional Committee for Medical and Health Research Ethics south-east, 2018/2198. URL: Prosjekt #632074 - Aktiv med web-basert støtte. - Cristin (registered 7 June 2019).

Effects of a mindfulness-based and acceptance-based group programme followed by physical activity for patients with fibromyalgia: a randomised controlled trial.

INTRODUCTION: Non-pharmacological approaches are recommended as first-line treatment for patients with fibromyalgia. This randomised controlled trial investigated the effects of a multicomponent rehabilitation programme for patients with recently diagnosed fibromyalgia in primary and secondary healthcare. METHODS: Patients with widespread pain ≥3 months were referred to rheumatologists for diagnostic clarification and assessment of study eligibility. Inclusion criteria were age 20-50 years, engaged in work or studies at present or during the past 2 years, and fibromyalgia diagnosed according to the American College of Rheumatology 2010 criteria. All eligible patients participated in a short patient education programme before inclusion and randomisation. The multicomponent programme, a 10-session mindfulness-based and acceptance-based group programme followed by 12 weeks of physical activity counselling was evaluated in comparison with treatment as usual, that is, no treatment or any other treatment of their choice. The primary outcome was the Patient Global Impression of Change (PGIC). Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life and work ability at 12-month follow-up. RESULTS: In total, 170 patients were randomised, 1:1, intervention:control. Overall, the multicomponent rehabilitation programme was not more effective than treatment as usual; 13% in the intervention group and 8% in the control group reported clinically relevant improvement in PGIC (p=0.28). No statistically significant between-group differences were found in any disease-related secondary outcomes. There were significant between-group differences in patient's tendency to be mindful (p=0.016) and perceived benefits of exercise (p=0.033) in favour of the intervention group. CONCLUSIONS: A multicomponent rehabilitation programme combining patient education with a mindfulness-based and acceptance-based group programme followed by physical activity counselling was not more effective than patient education and treatment as usual for patients with recently diagnosed fibromyalgia at 12-month follow-up. TRIAL REGISTRATION NUMBER: BMC Registry (ISRCTN96836577).

Criterion validity of The International Physical Activity Questionnaire-Short Form (IPAQ-SF) for use in clinical practice in patients with osteoarthritis.

BACKGROUND: To tailor physical activity treatment programs for patients with osteoarthritis, clinicians need valid and feasible measurement tools to evaluate habitual physical activity. The widely used International Physical Activity Questionnaire-Short Form (IPAQ-SF) is not previously validated in patients with osteoarthritis. PURPOSE: To assess the concurrent criterion validity of the IPAQ-SF in patients with osteoarthritis, using an accelerometer as a criterion-method. METHOD: Patients with osteoarthritis (n = 115) were recruited at The Division of Rheumatology and Research at Diakonhjemmet Hospital (Oslo, Norway). Physical activity was measured by patients wearing an accelerometer (ActiGraph wGT3X-BT) for seven consecutive days, followed by reporting their physical activity for the past 7 days using the IPAQ-SF. Comparison of proportions that fulfilled physical activity recommendations as measured by the two methods were tested by Pearson Chi-Square analysis. Differences in physical activity levels between the IPAQ-SF and the accelerometer were analyzed with Wilcoxon Signed-Rank Test and Spearman rank correlation test. Bland-Altman plots were used to visualize the concurrent criterion validity for total- and intensity-specific physical activity levels. RESULTS: In total, 93 patients provided complete physical activity data, mean (SD) age was 65 (8.7) years, 87% were women. According to the IPAQ-SF, 57% of the patients fulfilled the minimum physical activity recommendations compared to 31% according to the accelerometer (p = 0.043). When comparing the IPAQ-SF to the accelerometer we found significant under-reporting of total physical activity MET-minutes (p = < 0.001), sitting (p = < 0.001) and walking (p < 0.001), and significant over-reporting of moderate-to-vigorous physical activity (p < 0.001). For the different physical activity levels, correlations between the IPAQ-SF and the accelerometer ranged from rho 0.106 to 0.462. The Bland-Altman plots indicated an increased divergence between the two methods with increasing time spent on moderate-to-vigorous intensity physical activity. CONCLUSION: Physical activity is a core treatment of osteoarthritis. Our finding that patients tend to over-report activity of higher intensity and under-report low-intensity activity and sitting-time is of clinical importance. We conclude that the concurrent criterion validity of the IPAQ-SF was weak in patients with osteoarthritis.

Trajectories of change in symptom severity in patients with fibromyalgia: exploratory analyses of a randomised controlled trial.

The clinical picture of fibromyalgia (FM) symptoms fluctuates, and the symptom severity varies within and between patients. The current study aimed to identify groups of PDS trajectories and to explore differences in baseline characteristics between the potential groups of trajectories. We included patients from a completed randomised controlled trial, in total 170 patients diagnosed with FM according to the ACR 2010 criteria. The mean age was 40 years, and 94% were women. Symptom severity was assessed by the Polysymptomatic distress scale (PDS) [range 0 (no symptoms) to 31] at four timepoints over 13-18 months. Latent class growth analysis was used to identify patient trajectories based on their response pattern on the PDS. Potential differences in baseline characteristics between the trajectories were compared using appropriate statistical tests. Two distinct PDS trajectories were identified with 110 patients (65%) classified as the "no improvement" group and 60 (35%) as the "some improvement" group. Mean PDS scores at pre-baseline were ≥ 20 in both groups. At 12 months, the groups diverged, mean (SD) PDS score was 14 (3.82) in the "some improvement" group and 21 (4.12) in the "no improvement" group. There were no significant differences in baseline characteristics between the groups of PDS trajectories. We identified one group of FM patients that improved slightly during the study period and one group that not improved. There were no differences in baseline characteristics between the two groups.

Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated osteoarthritis care model: secondary analyses from a cluster-randomised stepped-wedge trial.

BACKGROUND: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. METHODS: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. RESULTS: Two hundred eighty-four intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (ORadjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. CONCLUSIONS: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02333656. Registered 7. January 2015.

Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis.

BACKGROUND: Maintenance or improvement of physical function is an important treatment target in the management of patients with axial spondyloarthritis (axSpA); measurement tools that can detect changes in physical function are therefore important. OBJECTIVES: The objective of this study was to compare responsiveness and interpretability of the patient-reported Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Performed-Based Improvement (ASPI) in measuring change in physical function after exercise in patients with axSpA. DESIGN: This was a sub-study of 58 patients nested within a randomized controlled trial comparing the effect of 12 weeks of exercise with usual care. METHODS: Responsiveness and interpretability were assessed according to the Consensus-based Standards for the selection of health status Measurement Instrument. Responsiveness was assessed by testing 8 predefined hypotheses for ASPI and BASFI. Interpretability was assessed by: (1) using patients' reported change as an anchor ("a little better" = minimal important change) and (2) by categorizing patients with a 20% improvement as responders. RESULTS: For ASPI and BASFI, 5 of 8 (63%) versus 2 of 8 (25%) of the predefined hypotheses for responsiveness were confirmed. The minimal important change values for improvement in physical function were 3.7 seconds in ASPI and 0.8 points (on a scale from 0 to 10) for BASFI. In the intervention group, 21 of 30 (70%) and 13 of 30 (43%) of the patients were categorized as responders measured with ASPI and BASFI, respectively. There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. LIMITATIONS: This study was limited by its moderate sample size. CONCLUSIONS: Our findings suggest that ASPI is preferable over BASFI when evaluating physical function after exercise interventions in patients with axSpA.

High intensity exercise for 3 months reduces disease activity in axial spondyloarthritis (axSpA): a multicentre randomised trial of 100 patients.

BACKGROUND: Exercise is considered important in the management of patients with rheumatic diseases, but the effect of high intensity exercises on disease activity is unknown. OBJECTIVE: To investigate the effectiveness of high intensity exercises on disease activity in patients with axial spondyloarthritis (axSpA). METHOD: Assessor blinded multicentre randomised controlled trial. 100 patients (aged from their 20s to their 60s) with axSpA were randomly assigned to an exercise group or to a no-intervention control group. The exercise group performed cardiorespiratory and muscular strength exercises at high intensity over 3 months. The control group received standard care and was instructed to maintain their usual physical activity level. Primary outcome was disease activity measured with the Ankylosing Spondylitis (AS) Disease Activity Scale (ASDAS, higher score=worst) and the Bath AS Disease Activity Index (BASDAI, 0-10, 10=worst). Secondary outcomes were inflammatory markers, physical function and cardiovascular (CV)-health. There was patient involvement in the design and reporting of this study. RESULTS: 97 of the 100 (97%) randomised patients completed the measurements after the intervention. There was a significant treatment effect of the intervention on the primary outcome (ASDAS: -0.6 [-0.8 to -0.3], p<0.001 and BASDAI: -1.2 [-1.8 to -0.7], p<0.001). Significant treatment effects were also seen for inflammation, physical function and CV-health. CONCLUSION: High intensity exercises reduced disease symptoms (pain, fatigue, stiffness) and also inflammation in patients with axSpA. It improves patients' function and CV health. This debunks concerns that high intensity exercise might exacerbate disease activity in patients with axSpA. TRIAL REGISTRATION NUMBER: NCT02356874.

Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002949.].

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02333656.

Mindfulness- and acceptance-based interventions for patients with fibromyalgia - A systematic review and meta-analyses.

OBJECTIVES: To analyze health effects of mindfulness- and acceptance-based interventions, including mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT). Additionally, we aimed to explore content and delivery components in terms of procedure, instructors, mode, length, fidelity and adherence in the included interventions. METHODS: We performed a systematic literature search in the databases MEDLINE, PsychINFO, CINAHL, EMBASE, Cochrane Central and AMED from 1990 to January 2019. We included randomized and quasi-randomized controlled trials analyzing health effects of mindfulness- and acceptance-based interventions for patients with fibromyalgia compared to no intervention, wait-list control, treatment as usual, or active interventions. MBSR combined with other treatments were included. Predefined outcomes were pain, fatigue, sleep quality, psychological distress, depression, anxiety, mindfulness, health-related quality of life and work ability. The Template for Intervention Description and Replication (TIDieR) checklist and guide was used to explore content and delivery components in the interventions. Meta-analyses were performed, and GRADE was used to assess the certainty in the evidence. RESULTS: The search identified 4430 records, of which nine original trials were included. The vast majority of the participants were women. The analyses showed small to moderate effects in favor of mindfulness- and acceptance-based interventions compared to controls in pain (SMD -0.46 [95% CI -0.75, -0.17]), depression (SMD -0.49 [95% CI -0.85, -0.12]), anxiety (SMD -0.37 [95% CI -0.71, -0.02]), mindfulness (SMD -0.40 [-0.69, -0.11]), sleep quality (SMD -0.33 [-0.70, 0.04]) and health-related quality of life (SMD -0.74 [95% CI -2.02, 0.54]) at end of treatment. The effects are uncertain due to individual study limitations, inconsistent results and imprecision. CONCLUSION: Health effects of mindfulness- and acceptance-based interventions for patients with fibromyalgia are promising but uncertain. Future trials should consider investigating whether strategies to improve adherence and fidelity of mindfulness- and acceptance-based interventions can improve health outcomes.

The Maternal and Paternal Effects on Clinically and Surgically Defined Osteoarthritis.

OBJECTIVE: It is currently unknown whether osteoarthritis (OA) is inherited mainly from the mother, father, or both. This study was undertaken to explore the effect of maternal and paternal factors on hip, knee, and hand OA in offspring. METHODS: Participants from the Musculoskeletal Pain in Ullensaker Study (MUST) (69% female; mean ± SD age 64 ± 9 years) and a Norwegian OA twin study (Nor-Twin) (56% female; 49 ± 11 years) reported whether their mother and/or father had OA. Using a recurrence risk estimation approach, we calculated whether maternal and paternal OA increased the risk of 1) surgically defined hip and knee OA (i.e., total joint replacement) and 2) clinically defined hip, knee, and hand OA (i.e., the American College of Rheumatology criteria) using logistic regression. Relative risks (RRs) with 95% confidence intervals (95% CIs) were calculated. RESULTS: Maternal OA consistently increased the risk of offspring OA across different OA locations and severities. Having a mother with OA increased the risk of any OA in daughters (RR 1.13 [95% CI 1.02-1.25] in the MUST cohort; RR 1.44 [95% CI 1.05-1.97] in the Nor-Twin cohort) but not (or with less certainty) in sons (RR 1.16 [95% CI 0.95-1.43] in the MUST cohort; RR 1.31 [95% CI 0.71-2.41] in the Nor-Twin cohort). Having a father with OA was less likely to increase the risk of any OA in daughters (RR 1.00 [95% CI 0.85-1.16] in the MUST cohort; RR 1.52 [95% CI 0.94-2.46] in the Nor-Twin cohort) and sons (RR 1.08 [95% CI 0.83-1.41] in the MUST cohort; RR 0.93 [95% CI 0.35-2.48] in the Nor-Twin cohort). CONCLUSION: OA in the mother increased the risk of surgically and clinically defined hip, knee, and hand OA in offspring, particularly in daughters. Our findings imply that heredity of OA may be linked to maternal genes and/or maternal-specific factors such as the fetal environment.

Shared Decision Making in Psoriasis: A Systematic Review of Quantitative and Qualitative Studies.

BACKGROUND: Patients with psoriasis face numerous treatment and self-management decisions. Shared decision making is a novel approach where patients' preferences and values are considered in cooperation with healthcare professionals before making treatment decisions. OBJECTIVE: The objective of this systematic review was to explore what is illuminated in psoriasis research regarding shared decision making, and to estimate the effects of shared decision-making interventions in this context. METHODS: Qualitative, quantitative, and mixed-methods studies were eligible for inclusion. We searched six electronic databases up to January 2018. Two reviewers independently applied inclusion and quality criteria. The SPIDER framework was used to identify eligibility criteria for study inclusion. Narrative and thematic syntheses were utilized to identify prominent themes emerging from the data. RESULTS: A total of 23 studies were included in the review. Of these, we included 18 studies (19 papers) to describe what was illuminated with regard to shared decision making in psoriasis research. Four major themes emerged: interpersonal communication; exchange of competence and knowledge; different world view; and involvement and preference, organized under two analytical themes; "Co-creation of decisions" and "Organization of treatment and treatment needs". For shared decision-making effects, we included four controlled studies. These varied in scope and interventional length and showed limited use of shared decision making-specific outcome measures, reflecting the early stage of the literature. Because of study heterogeneity, a meta-synthesis was not justified. CONCLUSIONS: There appears to be a need to strengthen the relationship between medical doctors and patients with psoriasis. The evident lack of knowledge about each other's competence and the lack of self-efficacy for both patients and providers challenges the basic principles of shared decision making. The effects of shared decision making in psoriasis are inconclusive, and more research appears necessary to determine the possible benefits of shared decision-making interventions.

Effects of a community-based multicomponent rehabilitation programme for patients with fibromyalgia: protocol for a randomised controlled trial.

INTRODUCTION: People with fibromyalgia (FM) suffer from symptoms such as widespread pain, non-refreshing sleep, fatigue and reduced quality of life. Effects of pharmacological treatment are questionable and non-pharmacological treatments are recommended as first-line therapy. To date the majority of patients with FM in Norway are not offered any targeted treatment. The aim of this randomised controlled trial is to investigate the effects of a community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling. MATERIALS AND METHODS: General practitioners refer potential participants to a rheumatologist in specialist healthcare for diagnostic clarification and assessment of comorbidities. Inclusion criteria are widespread pain/FM ≥3 months, age 20-50 and work participation (minimum part-time) within the last 2 years. The intervention group attends the VTP comprising 10 weekly 4 hour group sessions plus a booster session after 6 months. Thereafter, they receive 12 weeks of individually tailored physical exercise counselled by physiotherapists at community-based Healthy Life Centers. The control group follows treatment as usual. The primary outcome is Patient Global Impression of Change. Secondary outcomes include self-reported pain, fatigue and sleep quality, psychological distress, mindfulness, health-related quality of life, physical activity, work ability and exercise beliefs and habits. To achieve a power of 80% and allow for 10% dropout, 70 participants are needed in each arm. All analyses will be conducted on intention-to-treat bases and measured as differences between groups at 12 months follow-up. ETHICS AND DISSEMINATION: The study is approved and granted by the Norwegian South-Eastern Regional Health Authority (reference 2016015). Ethics approval was obtained from Regional Committee for Medical and Health Research Ethics (reference 2015/2447/REK sør-øst A). Results will be submitted to appropriate journals and presented in relevant conferences and social media. TRIAL REGISTRATION: ISRCTN 96836577.

Is the Association Between Obesity and Hip Osteoarthritis Surgery Explained by Familial Confounding?

BACKGROUND: Familial confounding is confounding due to genetics or environmental exposures shared by family members. We aimed to study whether familial confounding explains the association between body mass index (BMI) and severe hip osteoarthritis (OA). METHODS: We linked data from the Norwegian Arthroplasty Registry with the Norwegian Twin Registry on the National ID-number in 2014, generating a population-based prospective cohort study of same-sex twins born between 1915 and 1960 (53.4% females). BMI was calculated from self-reported height/weight. The outcome was incident hip arthroplasty due to OA (follow-up time, 1987-2014; 424 914 person-years). We performed sex-specific co-twin control analyses of dizygotic (N = 5,226) and monozygotic (MZ, N = 3,803) twin pairs using Cox regression models and explored reasons for any familial confounding using bivariate twin models. RESULTS: The mean (SD) BMI was 22.6 (2.96), peak lifetime BMI 25.6 (2.61), and N = 614 had hip surgery due to OA. In cohort analyses, BMI was associated with hip OA for women and men (hazard ratio [HR] = 1.09, 95% confidence intervals [CIs] = 1.06 to 1.11 and HR = 1.08, 95% CI = 1.04 to 1.12, respectively). When adjusting for familial confounding within MZ twins, the association got stronger for women (HR = 1.19; 95% CI = 1.05 to 1.36) but weaker for men (HR = 0.93; 95% CI = 0.75 to 1.16). There was no genetic overlap between BMI and hip OA, yet the familial confounding in men provides suggestive evidence that the association could be explained by shared environmental factors. CONCLUSION: The association between BMI and hip OA may be explained by familial confounding for men. For women, there was no evidence for familial confounding, consistent with a causal association. See video abstract at, http://links.lww.com/EDE/B336.