INTRODUCTION: Immune-mediated inflammatory diseases (IMIDs) are associated with reduced health-related quality of life (HRQol), increased risk of somatic and psychiatric comorbidities and reduced socioeconomic status. Individuals with one IMID have an increased risk for developing other IMIDs. The unmet needs in the care of patients with IMIDs may result from a lack of patient-centricity in the usual monodisciplinary siloed approach to these diseases. The advantages of novel interdisciplinary clinics towards the traditional therapeutic approach have not been investigated. The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared with usual care in a population of patients with the IMIDs: psoriasis, hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and inflammatory bowel disease. Our hypothesis is that an interdisciplinary combined clinic intervention will be more effective than usual care in improving clinical and patient-reported outcomes, and that a more effective screening and management of other IMIDs and comorbidities can be performed.

METHODS AND ANALYSIS: This is a randomised, usual care controlled, parallel-group pragmatic clinical trial. 300 consecutively enrolled participants with co-occurrence of at least two IMIDs are randomly assigned in a 2:1 ratio to either treatment in the interdisciplinary combined clinic or usual care. The study will consist of a 6-month active intervention period and a 6-month follow-up period where no intervention or incentives will be provided by the trial. The primary outcome is the change from baseline to 24 weeks on the Short-Form Health Survey (SF-36) Physical Component Summary. Additional patient-reported outcome measures and clinical measures are assessed as secondary outcomes.

ETHICS AND DISSEMINATION: Ethical approval of this study protocol was established by the institutional review board of the study site. The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with patient organisations.

TRIAL REGISTRATION NUMBER: NCT04200690.

Importance: Behavioral therapy and cognitive-behavioral therapy (CBT) programs targeting a single class of problems have not been widely implemented. The population of youths with common mental health problems is markedly undertreated. Objective: To determine the effectiveness of a new transdiagnostic CBT program (Mind My Mind [MMM]) compared with management as usual (MAU) in youths with emotional and behavioral problems below the threshold for referral to mental health care. Design, Setting, and Participants: This pragmatic, multisite, randomized clinical trial of MMM vs MAU was conducted from September 7, 2017, to August 28, 2019, including 8 weeks of postintervention follow-up, in 4 municipalities in Denmark. Consecutive help-seeking youths were randomized (1:1) to the MMM or the MAU group. Main inclusion criteria were age 6 to 16 years and anxiety, depressive symptoms, and/or behavioral disturbances as a primary problem. Data were analyzed from August 12 to October 25, 2019. Interventions: The MMM intervention consisted of 9 to 13 weekly, individually adapted sessions of manualized CBT delivered by local psychologists. The MAU group received 2 care coordination visits to enhance usual care. Main Outcomes and Measures: The primary outcome was change in mental health problems reported by parents at week 18, using the Strengths and Difficulties Questionnaire (SDQ) Impact scale (range, 0-10 points, with higher scores indicating greater severity of distress and impairment). Primary and secondary outcomes were assessed in the intention-To-Treat population at week 18. Maintenance effects were assessed at week 26. Results: A total of 396 youths (mean [SD] age, 10.3 [2.4] years; 206 [52.0%] boys) were randomized to MMM (n = 197) or MAU (n = 199), with primary outcome data available in 177 (89.8%) and 167 (83.9%), respectively, at 18 weeks. The SDQ Impact score decreased by 2.34 points with MMM and 1.23 with MAU, from initial scores of 4.12 and 4.21, respectively (between-group difference, 1.10 [95% CI, 0.75-1.45]; P <.001; Cohen d = 0.60). Number of responders (≥1-point reduction in SDQ Impact score) was greater with MMM than with MAU (144 of 197 [73.1%] vs 93 of 199 [46.7%]; number needed to treat, 4 [95% CI, 3-6]). Secondary outcomes indicated statistically significant benefits in parent-reported changes of anxiety, depressive symptoms, daily functioning, school attendance, and the principal problem. All benefits were maintained at week 26 except for school attendance. Conclusions and Relevance: In this randomized clinical trial, the scalable transdiagnostic cognitive-behavioral intervention MMM outperformed MAU in a community setting on multiple, clinically relevant domains in youth with emotional and behavioral problems. Trial Registration: ClinicalTrials.gov Identifier: NCT03535805.

Background: Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown.

Purpose: To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care.

Study design: Randomized controlled trial; Level of evidence, 1.

Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period.

Results: A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms: P = .834; sports and recreation: P = .723; work: P = .541; lifestyle: P = .508; emotions: P = .568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group.

Conclusion: PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year).

Triclosan (TCS) is an antimicrobial agent widely used in personal care products and a potential endocrine disruptor chemical (EDC). TCS can pass through the placental barrier. Any influence of EDCs on epigenetic changes of placenta and embryo may bring profound impact on later health. This study aimed to investigate the effects of TCS exposure on cell proliferation and migration, and the expression of imprinted genes IGF2/H19 and DNA methylation-related enzymes in human placental extravillous trophoblast cell line HTR-8/SVneo. After exposure to TCS levels of 0 (DMSO Control), 10⁻¹¹, 10⁻¹⁰, 10⁻⁹, 10⁻⁸, 10⁻⁷, 10⁻⁶, 10⁻⁵, 3 × 10⁻⁵, 6 × 10⁻⁵, 10⁻⁴ M and incubated for up to 36 h, cell proliferation and migration were examined by CCK-8, EdU incorporation assay and wound healing assay; the mRNA levels of IGF2, H19, DNA methyltransferases (Dnmt3a, Dnmt3b and Dnmt1), ten-eleven translocation enzymes (Tet1, Tet2 and Tet3) and IGF2 Receptor (IGF2R) were analyzed by qRT-PCR. The protein levels of IGF2 were measured by Western blot and ELISA. The cell viability turned to decline at TCS treatment of 3 × 10⁻⁵ M and above (all p < 0.05, compared to the DMSO Control). The cell migration decreased at TCS 10⁻⁵ and 3 × 10⁻⁵ M treatment (p < 0.05), but consistently unchanged at low dose of TCS from 10⁻⁹ to 10⁻⁷ M (p > 0.05). TCS treatments below cytotoxicity doses (< 10⁻⁵ M) did not significantly alter the mRNA levels of IGF2, Dnmt1, Dnmt3a, Dnmt3b, Tet1, Tet2 and Tet3, compared to DMSO Control treatment (all p > 0.05). The transcription level of H19 was up-regulated by TCS at 3 × 10⁻⁵ M. TCS at 10⁻⁷ and 6 × 10⁻⁵ M increased the protein level of IGF2 in cell supernatant. Our data suggest that high TCS exposure may suppress HTR-8/SVneo cells viability and migration, increase H19 gene expressions and IGF2 protein secretion. The exact mechanism of TCS action in human trophoblast needs further studies.

OBJECTIVE: To summarise the evidence on intra-articular therapies (IAT) to inform the 2020 EULAR recommendations.

METHODS: An overview of systematic reviews (SR) including randomised-controlled trials (RCTs) of IAT in adults with arthropathies was performed up to July 2020. Pain, function, and frequency of adverse events were the main efficacy and safety outcomes, respectively. Quality was assessed with the A MeaSurement Tool to Assess Systematic Reviews (AMSTAR)-2 tool.

RESULTS: Of 184 references identified, 16 met the inclusion criteria, and a search of their reference lists identified 16 additional SRs. After quality assessment, 29 were finally included. Of these, 18 focused on knee osteoarthritis (KOA), 6 on hip osteoarthritis (HOA), 3 on shoulder capsulitis (SC), and 3 on rheumatoid arthritis. Overall, hyaluronic acid showed a small effect on pain and function in KOA but not in HOA or shoulder capsulitis. Intra-articular glucocorticoids showed a small effect in pain and function in KOA and function in HOA and SC. Platelet-rich plasma showed benefit in pain and function in KOA but not in HOA. Mesenchymal stem cells behaved similarly. Most SR results were of moderate quality and RCTs included often presented a high risk of bias, mainly due to inadequate blinding and heterogeneous results. All interventions were well tolerated with no clear safety differences.

CONCLUSIONS: This overview underlines that most IAT currently used in KOA, HOA, and SC exert small effects and are well tolerated. However, no firm conclusions can be drawn for inflammatory arthritis due to the limited data found.

OBJECTIVE: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions.

METHODS: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set.

RESULTS: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention.

CONCLUSION: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set.

CLINICAL SIGNIFICANCE: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.

Knee pain is an early sign of later incident radiographic knee osteoarthritis (OA). However, the prevalence of knee pain in the general population is unknown. Additionally, it is unknown how people with knee pain choose to self-manage the condition and if the perception of the illness affects these choices. In this study, 9086 citizens between 60-69 years old in the municipality of Frederiksberg, Copenhagen, Denmark, were surveyed, of which 4292 responded. The prevalence of knee pain was estimated, and associations between illness perceptions (brief illness perception questionnaire [B-IPQ]), self-management strategies, and knee symptoms were assessed. The prevalence of knee pain was 21.4% of which 40.5% reported to use no self-management strategies (non-users). These non-users perceived their knee pain as less threatening and reported less severe symptoms than users of self-management strategies. Further, we found that a more positive illness perception was associated with less severe knee symptoms. In conclusion, among Danes aged 60-69 years, the knee pain prevalence is 21.4%, of which 40.5% use no treatment and perceive the condition as non-threatening. These non-users with knee pain represent a subpopulation being at increased risk of developing knee OA later in life, and there is a potential preventive gain in identifying these persons.

OBJECTIVE: To produce European League Against Rheumatism (EULAR) recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs).

METHODS: Based on the literature reviews and expert opinion (through Delphi surveys), a taskforce of 23 members (12 experts in ultrasound in RMDs, 9 in methodology and biostatistics together with a patient research partner and a health professional in rheumatology) developed a checklist of items to be reported in every RMD study using ultrasound. This checklist was further refined by involving a panel of 79 external experts (musculoskeletal imaging experts, methodologists, journal editors), who evaluated its comprehensibility, feasibility and comprehensiveness. Agreement on each proposed item was assessed with an 11-point Likert scale, grading from 0 (total disagreement) to 10 (full agreement).

RESULTS: Two face-to-face meetings, as well as two Delphi rounds of voting, resulted in a final checklist of 23 items, including a glossary of terminology. Twenty-one of these were considered 'mandatory' items to be reported in every study (such as blinding, development of scoring systems, definition of target pathologies) and 2 'optional' to be reported only if applicable, such as possible confounding factors (ie, ambient conditions) or experience of the sonographers.

CONCLUSION: An EULAR taskforce developed a checklist to ensure transparent and comprehensive reporting of aspects concerning research and procedures that need to be presented in studies using ultrasound in RMDs. This checklist, if widely adopted by authors and editors, will greatly improve the interpretability of study development and results, including the assessment of validity, generalisability and applicability.

BACKGROUND: Effective interventions and commercial programmes for weight loss (WL) are widely available, but most people regain weight. Few effective WL maintenance (WLM) solutions exist. The most promising evidence-based behaviour change techniques for WLM are self-monitoring, goal setting, action planning and control, building self-efficacy, and techniques that promote autonomous motivation (e.g., provide choice). Stress management and emotion regulation techniques show potential for prevention of relapse and weight regain. Digital technologies (including networked-wireless tracking technologies, online tools and smartphone apps, multimedia resources, and internet-based support) offer attractive tools for teaching and supporting long-term behaviour change techniques. However, many digital offerings for weight management tend not to include evidence-based content and the evidence base is still limited. The Project: First, the project examined why, when, and how many European citizens make WL and WLM attempts and how successful they are. Second, the project employed the most up-to-date behavioural science research to develop a digital toolkit for WLM based on 2 key conditions, i.e., self-management (self-regulation and motivation) of behaviour and self-management of emotional responses for WLM. Then, the NoHoW trial tested the efficacy of this digital toolkit in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial BMI ≥25). The primary outcome was change in weight (kg) at 12 months from baseline. Secondary outcomes included biological, psychological, and behavioural moderators and mediators of long-term energy balance (EB) behaviours, and user experience, acceptability, and cost-effectiveness.

IMPACT: The project will directly feed results from studies on European consumer behaviour, design and evaluation of digital toolkits self-management of EB behaviours into development of new products and services for WLM and digital health. The project has developed a framework and digital architecture for interventions in the context of EB tracking and will generate results that will help inform the next generation of personalised interventions for effective self-management of weight and health.