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Objectives Obesity and psoriatic arthritis (PsA) have a complicated relationship. While weight alone does not cause PsA, it is suspected to cause worse symptoms. Neutrophil gelatinase-associated lipocalin (NGAL) is secreted through various cell types. Our objective was to assess the changes and trajectories in serum NGAL and clinical outcomes in patients with PsA during 12 months of anti-inflammatory treatment. Method This exploratory prospective cohort study enrolled PsA patients initiating conventional synthetic or biological disease-modifying anti-rheumatic drugs (csDMARDs/bDMARDs). Clinical, biomarker, and patient-reported outcome measures were retrieved at baseline, and 4 and 12 months. Control groups at baseline were psoriasis (PsO) patients and apparently healthy controls. The serum NGAL concentration was quantified by a high-performance singleplex immunoassay. Results In total, 117 PsA patients started a csDMARD or bDMARD, and were compared indirectly at baseline with a cross-sectional sample of 20 PsO patients and 20 healthy controls. The trajectory in NGAL related to anti-inflammatory treatment for all included PsA patients showed an overall change of −11% from baseline to 12 months. Trajectories in NGAL for patients with PsA, divided into treatment groups, showed no clear trend in clinically significant decrease or increase following anti-inflammatory treatment. NGAL concentrations in the PsA group at baseline corresponded to the levels in the control groups. No correlation was found between changes in NGAL and changes in PsA outcomes. Conclusion Based on these results, serum NGAL does not add any value as a biomarker in patients with peripheral PsA, either for disease activity or for monitoring., Objectives: Obesity and psoriatic arthritis (PsA) have a complicated relationship. While weight alone does not cause PsA, it is suspected to cause worse symptoms. Neutrophil gelatinase-associated lipocalin (NGAL) is secreted through various cell types. Our objective was to assess the changes and trajectories in serum NGAL and clinical outcomes in patients with PsA during 12 months of anti-inflammatory treatment. Method: This exploratory prospective cohort study enrolled PsA patients initiating conventional synthetic or biological disease-modifying anti-rheumatic drugs (csDMARDs/bDMARDs). Clinical, biomarker, and patient-reported outcome measures were retrieved at baseline, and 4 and 12 months. Control groups at baseline were psoriasis (PsO) patients and apparently healthy controls. The serum NGAL concentration was quantified by a high-performance singleplex immunoassay. Results: In total, 117 PsA patients started a csDMARD or bDMARD, and were compared indirectly at baseline with a cross-sectional sample of 20 PsO patients and 20 healthy controls. The trajectory in NGAL related to anti-inflammatory treatment for all included PsA patients showed an overall change of −11% from baseline to 12 months. Trajectories in NGAL for patients with PsA, divided into treatment groups, showed no clear trend in clinically significant decrease or increase following anti-inflammatory treatment. NGAL concentrations in the PsA group at baseline corresponded to the levels in the control groups. No correlation was found between changes in NGAL and changes in PsA outcomes. Conclusion: Based on these results, serum NGAL does not add any value as a biomarker in patients with peripheral PsA, either for disease activity or for monitoring.

Objective: To identify contextual factors that modify the treatment effect of the ‘Good Life with osteoArthritis in Denmark’ (GLAD) exercise and education programme compared to open-label placebo (OLP) on knee pain in individuals with knee osteoarthritis (OA). Methods: Secondary effect modifier analysis of a randomised controlled trial. 206 participants with symptomatic and radiographic knee OA were randomised to either the 8-week GLAD programme (n = 102) or OLP given as 4 intra-articular saline injections over 8 weeks (n = 104). The primary outcome was change from baseline to week 9 in the Knee injury and Osteoarthritis Outcome Score questionnaire (KOOS) pain subscale (range 0 (worst) to 100 (best)). Subgroups were created based on baseline information: BMI, swollen study knee, bilateral radiographic knee OA, sports participation as a young adult, sex, median age, a priori treatment preference, regular use of analgesics (NSAIDs or paracetamol), radiographic disease severity, and presence of constant or intermittent pain. Results: Participants who reported use of analgesics at baseline seem to benefit from the GLAD programme over OLP (subgroup contrast: 10.3 KOOS pain points (95% CI 3.0 to 17.6)). Participants with constant pain at baseline also seem to benefit from GLAD over OLP (subgroup contrast: 10.0 points (95% CI 2.8 to 17.2)). Conclusions: These results imply that patients who take analgesics or report constant knee pain, GLAD seems to yield clinically relevant benefits on knee pain when compared to OLP. The results support a stratified recommendation of GLAD as management of knee OA. Trial registration: ClinicalTrials.gov Identifier: NCT03843931. EudraCT number 2019-000809-71.

Objective Patient education is recommended as an integral component of the therapeutic plan for the management of chronic widespread pain (CWP) and fibromyalgia (FM). The key purpose of patient education is to increase the patient’s competence to manage his or her own health requirements, encouraging self-management and a return to desired everyday activities and lifestyle. The aim of this systematic review was to evaluate the evidence for the benefits and potential harms associated with the use of patient education as a stand-alone intervention for individuals with CWP and FM through randomized controlled trials (RCTs). Method On 24 November 2021 a systematic search of PubMed, MEDLINE, Embase, CENTRAL, PsycINFO, CINAHL, ClinicalTrials.gov, American College of Rheumatology, European League Against Rheumatism, and the World Health Organization International Clinical Trials Registry Platform identified 2069 studies. After full-text screening, five RCT studies were found to be eligible for the qualitative evidence synthesis. Results Patient education as a stand-alone intervention presented an improvement in patients’ global assessment (standardized mean difference 0.79, 95% confidence interval 0.13 to 1.46). When comparing patient education with usual care, no intervention, or waiting list, no differences were found for functioning, level of pain, emotional distress in regard to anxiety and depression, or pain cognition. Conclusion This review reveals the need for RCTs investigating patient education as a stand-alone intervention for patients with FM, measuring outcomes such as disease acceptance, health-related quality of life, enhancement of patients’ knowledge of pain, pain coping skills, and evaluation of prioritized learning outcomes., ObjectivePatient education is recommended as an integral component of the therapeutic plan for the management of chronic widespread pain (CWP) and fibromyalgia (FM). The key purpose of patient education is to increase the patient's competence to manage his or her own health requirements, encouraging self-management and a return to desired everyday activities and lifestyle. The aim of this systematic review was to evaluate the evidence for the benefits and potential harms associated with the use of patient education as a stand-alone intervention for individuals with CWP and FM through randomized controlled trials (RCTs).MethodOn 24 November 2021 a systematic search of PubMed, MEDLINE, Embase, CENTRAL, PsycINFO, CINAHL, ClinicalTrials.gov, American College of Rheumatology, European League Against Rheumatism, and the World Health Organization International Clinical Trials Registry Platform identified 2069 studies. After full-text screening, five RCT studies were found to be eligible for the qualitative evidence synthesis.ResultsPatient education as a stand-alone intervention presented an improvement in patients' global assessment (standardized mean difference 0.79, 95% confidence interval 0.13 to 1.46). When comparing patient education with usual care, no intervention, or waiting list, no differences were found for functioning, level of pain, emotional distress in regard to anxiety and depression, or pain cognition.ConclusionThis review reveals the need for RCTs investigating patient education as a stand-alone intervention for patients with FM, measuring outcomes such as disease acceptance, health-related quality of life, enhancement of patients' knowledge of pain, pain coping skills, and evaluation of prioritized learning outcomes.

BACKGROUND: Monitoring disease activity over time is a prerequisite for clinical practice and research. Valid and reliable outcome measurements instruments (OMIs) and staging systems provide researchers and clinicians with benchmark tools to assess the primary and secondary outcomes of interventional trials and to guide treatment selection properly.OBJECTIVES: To investigate interrater reliability and agreement in instruments currently used in Hidradenitis Suppurativa (HS) with HS-experienced dermatologists being the rater population of interest.METHODS: In a prospective completely balanced design, 24 HS patients underwent a physical examination by 12 raters (288 assessments) using nine instruments; analysed using generalised linear mixed models.RESULTS: For the staging systems, the study found good interrater reliability for Hurley staging in the axillae and gluteal region, moderate interrater reliability for Hurley staging in the groin and Physician's Global Assessment, and fair interrater reliability for Hurley staging refined and International HS Severity Scoring System. For all the tested OMIs, the observed intervals for limits of agreement were very wide relative to the ranges of the scales.CONCLUSION: The very wide intervals for limits of agreement imply that substantial changes are needed in clinical research in order to rule out measurement error. The results illustrate a difficulty, even for experienced HS-experts, to agree on the type and number of lesions when evaluating disease severity. The apparent caveats call for global efforts, such as the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) to reach consensus on how valid HS physical signs are best measured reliably in randomised trials. This article is protected by copyright. All rights reserved.

Hidradenitis suppurativa (HS) is a long-lasting skin disease with flares of painful boils in areas where skin meets skin, such as the armpits and groins. It affects somewhere between 1 and 40 people out of 1000 worldwide. When trying to measure the effect of a treatment in a clinical trial, so-called 'outcome measurement instruments' are used. These are ways of estimating 'how much' disease is present. It is obviously important that outcome measurement instruments measure the right thing and do not vary at random. It has previously been shown that outcome measurement instruments used in HS trials lack proof of their reliability. This study therefore aimed to find out how consistently 12 HS-experienced dermatologists would score 24 patients with HS, using nine different instruments. The study showed that one called Hurley staging was an acceptable instrument in terms of consistency of scores. However, Hurley staging is suited only for severity staging e.g. to guide the most appropriate treatment in each stage. For instruments designed to measure changes in disease severity, low agreement between the rating dermatologists was found. Therefore, the results question whether HS physical signs are best measured by traditional instruments based on a physician counting individual HS lesions (affected patches). As a result, other assessment methods of physical signs in HS, using technology such as ultrasound, should also be considered.

OBJECTIVE: To examine the reporting completeness of exercise-based interventions for knee osteoarthritis (OA) in studies that form the basis of current clinical guidelines, and examine if the clinical benefit (pain and disability) from exercise is associated with the intervention reporting completeness.DESIGN: Review of clinical OA guidelines METHODS: We searched MEDLINE and EMBASE for guidelines published between 2006 and 2016 including recommendations about exercise for knee OA. The studies used to inform a recommendation were reviewed for exercise reporting completeness. Reporting completeness was evaluated using a 12-item checklist; a combination of the Template for Intervention Description and Replication (TIDieR) and Consensus on Exercise Reporting Template (CERT). Each item was scored 'YES' or 'NO' and summarized as a proportion of interventions with complete descriptions and each intervention's completeness was summarized as the percentage of completely described items. The association between intervention description completeness score and clinical benefits was analyzed with a multilevel meta-regression.RESULTS: From 10 clinical guidelines, we identified 103 original studies of which 100 were retrievable (including 133 interventions with 6,926 patients). No interventions were completely described on all 12 items (median 33% of items complete; range 17-75%). The meta-regression analysis indicated that poorer reporting was associated with greater effects on pain and no association with effects on disability.CONCLUSION: The inadequate description of recommended interventions for knee OA is a serious problem that precludes replication of effective interventions in clinical practice. By consequence, the relevance and usability of clinical guideline documents and original study reports are diminished.PROSPERO: CRD42016039742.

Background: There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome-reporting bias and limits the ability to synthesize evidence. Objectives: To achieve global multistakeholder consensus on a core outcome set (COS) of domains regarding what to measure in clinical trials for HS. Methods: Six stakeholder groups participated in a Delphi process that included five anonymous e-Delphi rounds and four face-to-face consensus meetings to reach consensus on the final COS. The aim was for a 1 : 1 ratio of patients to healthcare professionals (HCPs). Results: A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process, which yielded a final COS that included five domains: pain, physical signs, HS-specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by HCPs but is recommended for the core domain set. Conclusions: Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected.

BACKGROUND: Several studies have examined whether use of substances can cause schizophrenia. However, due to methodological limitations in the existing literature (e.g. selection bias and lack of adjustment of co-abuse) uncertainties still remain. We aimed to investigate whether substance abuse increases the risk of developing schizophrenia, addressing some of these limitations.METHOD: The longitudinal, nationwide Danish registers were linked to establish a cohort of 3 133 968 individuals (105 178 673 person-years at risk), identifying 204 505 individuals diagnosed with substance abuse and 21 305 diagnosed with schizophrenia. Information regarding substance abuse was extracted from several registers and did not include psychotic symptoms caused by substance abuse in the definition. This resulted in a large, generalizable sample of exposed individuals. The data was analysed using Cox regression analyses, and adjusted for calendar year, gender, urbanicity, co-abuse, other psychiatric diagnosis, parental substance abuse, psychiatric history, immigration and socioeconomic status.RESULTS: A diagnosis of substance abuse increased the overall risk of developing schizophrenia [hazard ratio (HR) 6.04, 95% confidence interval (CI) 5.84-6.26]. Cannabis (HR 5.20, 95% CI 4.86-5.57) and alcohol (HR 3.38, 95% CI 3.24-3.53) presented the strongest associations. Abuse of hallucinogens (HR 1.86, 95% CI 1.43-2.41), sedatives (HR 1.68, 95% CI 1.49-1.90), and other substances (HR 2.85, 95% CI 2.58-3.15) also increased the risk significantly. The risk was found to be significant even 10-15 years subsequent to a diagnosis of substance abuse.CONCLUSION: Our results illustrate robust associations between almost any type of substance abuse and an increased risk of developing schizophrenia later in life.

To assess disease characteristics and outcome in Danish juvenile dermatomyositis (JDM) patients (1977-2007).