Publications by authors named "Sabrina M Nielsen"

17 Publications

  • Page 1 of 1

One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial.

BMJ Open Diabetes Res Care 2021 Jan;9(1)

Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Introduction: The effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.

Research Design And Methods: We performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, 'U-TURN'), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).

Results: We included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI -0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI -4.6 to -0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).

Conclusion: In persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.

Trial Registration Number: NCT02417012.
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http://dx.doi.org/10.1136/bmjdrc-2020-001840DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812095PMC
January 2021

Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial.

JAMA Psychiatry 2021 Mar;78(3):250-260

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department of Psychiatry and Molecular Medicine, Hempstead, New York.

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.
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http://dx.doi.org/10.1001/jamapsychiatry.2020.4045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7758821PMC
March 2021

Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients: A systematic review and meta-analysis.

Semin Arthritis Rheum 2020 12 2;50(6):1400-1405. Epub 2020 Mar 2.

Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany.

Objective: Randomized controlled trials (RCTs) are considered the gold standard in clinical research due to credible causality. Their results, however, may not be generalizable to real-world populations. While glucocorticoids (GCs) remain a mainstay of rheumatoid arthritis (RA) treatment, it is unclear whether the results of GC-RCTs are generalizable to current real-world RA patients.

Methods: MEDLINE was searched for RCTs and, as comparators, cohort studies (CSs) in RA evaluating systemic GCs. Random-effects meta-analyses were performed for descriptive baseline characteristics (including general demographics, comorbidities, and disease activity) that have been shown to be able to modify the benefit-risk-ratio of various RA therapeutics. These meta-analyses were stratified by study type (RCT and CS). Stratified estimates were subsequently compared. Further sensitivity analyses were performed stratifying by disease duration.

Results: 56 RCTs (7053 participants) and 10 CSs (14,688 participants) were included. 12 characteristics were reported frequently enough to allow for comparative analysis. In 10/12 characteristics (83%), RCT estimates did not appear to differ from CS estimates. However, RCT participants were younger (-4.7 years [95% CI -7.2 to -2.1]; p < 0.001) and had higher erythrocyte sedimentation rates (11.8 mm/h [5.7 to 17.8]; p < 0.001) than CS participants. Comorbidities could not be assessed due to insufficient reporting.

Conclusion: Our findings suggest that evidence from GC trials in RA is of acceptable generalizability to current real-world patients - especially compared to findings from biologic agents in RA. However, RCT participants were younger than real-world patients, potentially limiting the generalizability of trial results to elderly patients.

Systematic Review Registration: PROSPERO (CRD42019134675).
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http://dx.doi.org/10.1016/j.semarthrit.2020.02.016DOI Listing
December 2020

Controversy and Debate on Meta-epidemiology. Paper 1: Treatment effect sizes vary in randomized trials depending on the type of outcome measure.

J Clin Epidemiol 2020 07 23;123:27-38. Epub 2020 Mar 23.

The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark. Electronic address:

Objective: To compare estimated treatment effects of physical therapy (PT) between patient-reported outcome measures (PROMs) and outcomes measured in other ways.

Study Design And Setting: We selected randomized trials of PT with both a PROM and a non-PROM included in Cochrane systematic reviews (CSRs). Two reviewers independently extracted data and risk-of-bias assessments. Our primary outcome was the ratio of odds ratios (RORs), used to quantify how effect varies between PROMs and non-PROMs; an ROR > 1 indicates larger effect when assessed by using PROMs. We used REML-methods to estimate associations of trial characteristics with effects and between-trial heterogeneity.

Results: From 90 relevant CSRs, 205 PT trials were included. The summary ROR across all the comparisons was not statistically significant (ROR, 0.88 [95% CI: 0.70-1.12]; P = 0.30); however, the heterogeneity was substantial (I = 88.1%). When stratifying non-PROMs further into clearly objective non-PROMs (e.g., biomarkers) and other non-PROMs (e.g., aerobic capacity), the PROMs appeared more favorable than did clearly objective non-PROMs (ROR, 1.92 [95% CI: 0.99-3.72]; P = 0.05).

Conclusion: Estimated treatment effects based on PROMs are generally comparable with treatment effects measured in other ways. However, in our study, PROMs indicate a more favorable treatment effect compared with treatment effects based on clearly objective outcomes.
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http://dx.doi.org/10.1016/j.jclinepi.2019.10.016DOI Listing
July 2020

Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

Mayo Clin Proc 2020 03 30;95(3):488-503. Epub 2020 Jan 30.

Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Objective: To investigate whether a dose-response relationship exists between volume of exercise and discontinuation of glucose-lowering medication treatment in patients with type 2 diabetes.

Patients And Methods: Secondary analyses of a randomized controlled exercise-based lifestyle intervention trial (April 29, 2015 to August 17, 2016). Patients with non-insulin-dependent type 2 diabetes were randomly assigned to an intensive lifestyle intervention (U-TURN) or standard-care group. Both groups received lifestyle advice and objective target-driven medical regulation. Additionally, the U-TURN group received supervised exercise and individualized dietary counseling. Of the 98 randomly assigned participants, 92 were included in the analysis (U-TURN, n=61, standard care, n=31). Participants in the U-TURN group were stratified into tertiles based on accumulated volumes of exercise completed during the 1-year intervention.

Results: Median exercise levels of 178 (interquartile range [IQR], 121-213; lower tertile), 296 (IQR, 261-310; intermediate tertile), and 380 minutes per week (IQR, 355-446; upper tertile) were associated with higher odds of discontinuing treatment with glucose-lowering medication, with corresponding odds ratios of 12.1 (95% CI, 1.2-119; number needed to treat: 4), 30.2 (95% CI, 2.9-318.5; 3), and 34.4 (95% CI, 4.1-290.1; 2), respectively, when comparing with standard care. Cardiovascular risk factors such as glycated hemoglobin A levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group.

Conclusion: Exercise volume is associated with discontinuation of glucose-lowering medication treatment in a dose-dependent manner, as are important cardiovascular risk factors in well-treated participants with type 2 diabetes and disease duration less than 10 years. Further studies are needed to support these findings.

Study Registration: ClinicalTrials.gov registration (NCT02417012).
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http://dx.doi.org/10.1016/j.mayocp.2019.09.005DOI Listing
March 2020

Development of a Scoring Tool for Chronic Nonbacterial Osteomyelitis Magnetic Resonance Imaging and Evaluation of its Interrater Reliability.

J Rheumatol 2020 05 1;47(5):739-747. Epub 2019 Oct 1.

From the Seattle Children's Hospital, Department of Pediatrics, and Department of Radiology, University of Washington; Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington; Department of Radiology, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; The Rheumatology Research Unit, Department of Rheumatology, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Diagnostic and Interventional Radiology, University Hospital of Ulm, Ulm, Germany; Department of Radiology, Stony Brook University Hospital, Stony Brook, New York; Department of Radiology, Hackensack University Medical Center, Hackensack, New Jersey, USA; Department of Medical Imaging, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Department of Radiology, Christian Medical College and Hospital, Vellore, India; Department of Imaging, Bambino Gesù Children's Hospital, Institute for Research and Health Care (IRCCS), Rome, Italy; Pediatric Rheumatology, Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia; Department of Pediatrics, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.

Objective: Serial magnetic resonance imaging (MRI) examinations are often needed in chronic nonbacterial osteomyelitis (CNO) to determine the objective response to treatment. Our objectives in this study were (1) to develop a consensus-based MRI scoring tool for clinical and research use in CNO; and (2) to evaluate interrater reliability and agreement using whole-body (WB)-MRI from children with CNO.

Methods: Eleven pediatric radiologists discussed definitions and grading of signal intensity, size of signal abnormality within bone marrow, and associated features on MRI through monthly conference calls and a consensus meeting, using a nominal group technique in July 2017. WB-MRI scans from children with CNO were deidentified for training reading and an interrater reliability study. The reading by each radiologist was conducted in a randomized order. Interrater reliability for abnormal signal and severity were assessed using free-marginal κ statistics.

Results: Radiologists reached a consensus on grading CNO-specific MRI findings and on describing bone units based on anatomy. A total of 45 sets of WB-MRI scans, including 4 sets of non-CNO MRI examinations, were selected for the final reading. The mean κ of each category of bones was > 0.7 with majority > 0.9 demonstrating substantial/almost perfect interrater reliability of readings among radiologists. The agreement on signal intensity and the size of signal abnormality within the most commonly affected bones (femur and tibia) were lower than those of other bones.

Conclusion: The chronic nonbacterial osteomyelitis magnetic resonance imaging scoring (CROMRIS) tool is a comprehensive standardized scoring tool for MRI in children with CNO. Our interrater study demonstrated good interrater reliability and agreement of readings.
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http://dx.doi.org/10.3899/jrheum.190186DOI Listing
May 2020

Sustained Long-Term Efficacy of Motivational Counseling and Text Message Reminders on Daily Sitting Time in Patients With Rheumatoid Arthritis: Long-Term Follow-up of a Randomized, Parallel-Group Trial.

Arthritis Care Res (Hoboken) 2020 11;72(11):1560-1570

Rigshospitalet, Glostrup, and University of Copenhagen, Copenhagen, Denmark.

Objective: To evaluate the 18-month postintervention efficacy following a 4-month individually tailored behavioral intervention on daily sitting time in patients with rheumatoid arthritis (RA).

Methods: In an observer-blinded randomized trial, 150 RA patients were included. During 4 months, the intervention group (n = 75) received 3 motivational counseling sessions and tailored text messages aimed at increasing light-intensity physical activity through reduction of sedentary behavior. The control group (n = 75) maintained their usual lifestyle. The primary outcome was change from baseline to 18 months postintervention in objectively measured daily sitting time (using ActivPAL). Secondary outcomes included changes in clinical patient-reported outcomes and cardiometabolic biomarkers. A mixed-effect repeated measures analysis of covariance model in the intent-to-treat population was applied.

Results: At 22 months follow-up from baseline, 12 participants were lost to follow-up. Compared to baseline, sitting time in the intervention group decreased 1.10 hours/day, whereas it increased by 1.32 hours/day in the control group, a between-group difference of -2.43 hours/day (95% confidence interval [95% CI] -2.99, -1.86; P < 0.0001) favoring the intervention group. For most secondary outcomes, between-group differences favored the intervention: visual analog scale (VAS) pain -15.51 mm (95% CI -23.42, -7.60), VAS fatigue -12.30 mm (95% CI -20.71, -3.88), physical function -0.39 Health Assessment Questionnaire units (95% CI -0.53, -0.26), total cholesterol -0.86 mmoles/liter (95% CI -1.03, -0.68), triglycerides -0.26 mmoles/liter (95% CI -0.43, -0.09), and average glucose -1.15 mmoles/liter (95% CI -1.39, -0.91).

Conclusion: The 4-month postintervention results showed that patients in the intervention reduced their daily sitting time and improved patient-reported outcomes and total cholesterol levels compared to the control group. Eighteen months after intervention, patients in the intervention group were still significantly less sedentary than controls. Findings suggest that a behavioral approach is beneficial for promoting long-term physical activity and health in patients with RA.
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http://dx.doi.org/10.1002/acr.24060DOI Listing
November 2020

Association Between Participant Retention and the Proportion of Included Elderly People in Rheumatology Trials: Results From a Series of Exploratory Meta-Regression Analyses.

Arthritis Care Res (Hoboken) 2020 10;72(10):1490-1496

Charité-University Medicine Berlin, Berlin, Germany.

Objective: The elderly, a population defined by an age of ≥65 years, are underrepresented in rheumatology trials, possibly due to investigators' concerns of increased premature discontinuations in higher age groups. The present study was undertaken to evaluate whether the proportion of included elderly individuals (PE) is independently associated with participant retention in rheumatology trials.

Methods: Medline was searched for randomized controlled trials (RCTs) in rheumatoid arthritis (RA) and osteoarthritis (OA) of any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. We used mixed-effects meta-regression models including several covariates to assess whether there is an independent association between PE and participant retention. Using sensitivity analyses, we evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE).

Results: In total, 243 RCTs comprising >48,000 participants were included. Pooled participant retention was 88%. PE was not associated with retention in the unadjusted (P = 0.97) or adjusted (all: P ≥ 0.14) models. Of all covariates, only study duration and type of intervention were associated with retention (both: P < 0.001). Post hoc analyses allowing for interaction revealed a small but statistically significant positive association between PE and retention in pharmacologic interventions and a negative association in physical/physiotherapeutic interventions (overall P for interaction = 0.05). No associations were found for PE and attrition due to LoE or AE.

Conclusion: Participant retention in RA and OA trials is high and not associated with PE. These findings should motivate investigators to include more elderly participants in rheumatology trials.
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http://dx.doi.org/10.1002/acr.24051DOI Listing
October 2020

Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I).

J Rheumatol 2020 05 15;47(5):658-667. Epub 2019 Aug 15.

From The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense; Zitelab ApS, Copenhagen, Denmark; Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Institute of Rheumatology, Prague; Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objective: In an eHealth setting, to investigate intra- and interrater reliability and agreement of joint assessments and Disease Activity Score using C-reactive protein (DAS28-CRP) in patients with rheumatoid arthritis (RA) and test the effect of repeated joint assessment training.

Methods: Patients with DAS28-CRP ≤ 5.1 were included in a prospective cohort study (clinicaltrials.gov: NCT02317939). Intrarater reliability and agreement of patient-performed joint counts were assessed through completion of 5 joint assessments over a 2-month period. All patients received training on joint assessment at baseline; only half of the patients received repeated training. A subset of patients was included in an appraisal of interrater reliability and agreement comparing joint assessments completed by patients, healthcare professionals (HCP), and ultrasonography. Cohen's κ coefficients and intraclass correlation coefficients (ICC) were used for quantifying of reliability of joint assessments and DAS28-CRP. Agreement was assessed using Bland-Altman plots.

Results: Intrarater reliability was excellent with ICC of 0.87 (95% CI 0.83-0.90) and minimal detectable change of 1.13. ICC for interrater reliability ranged between 0.69 and 0.90 (good to excellent). Patients tended to rate DAS28-CRP slightly higher than HCP. In patients receiving repeated training, a mean difference in DAS28-CRP of -0.08 was observed (limits of agreements of -1.06 and 0.90). After 2 months, reliability between patients and HCP was similar between groups receiving single or repeated training.

Conclusion: Patient-performed assessments of joints and DAS28-CRP in an eHealth home-monitoring solution were reliable and comparable with HCP. Patients can acquire the necessary skills to conduct a correct joint assessment after initial and thorough training. [clinicaltrials.gov (NCT02317939)].
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http://dx.doi.org/10.3899/jrheum.181362DOI Listing
May 2020

Pitfalls in meta-analysis.

Inflammopharmacology 2020 04 28;28(2):617-618. Epub 2019 May 28.

Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000, Frederiksberg, Denmark.

Systematic reviews with meta-analyses are powerful instruments to synthesize research. If done correctly, they may constitute the highest level of evidence by combining several individual studies. As high-quality evidence is scarce in the field of complementary medicine, meta-analyses of randomized trials may shed new light on both efficacy and safety, but they must be properly conducted. In this commentary to a recently published paper we elaborate on methodological pitfalls in meta-analysis that every researcher should avoid to gain true high-quality evidence.
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http://dx.doi.org/10.1007/s10787-019-00606-4DOI Listing
April 2020

Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative.

J Rheumatol 2019 09 15;46(9):1159-1163. Epub 2019 Jan 15.

From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; The Rheumatology Research Unit, Department of Rheumatology, Odense University Hospital; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Children's Hospital of Eastern Ontario Research Institute; Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, Ottawa; Institute for Work and Health, Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute and the Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; Department of Epidemiology and Biostatistics; Amsterdam Rheumatology and Immunology Center; Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam; Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre; Care and Public Health Research Institute, Maastricht University, Maastricht; University of Twente, Department of Psychology, Health and Technology, Enschede, the Netherlands; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles; Medicine Service, VA Medical Center, Birmingham; Department of Medicine, School of Medicine, University of Alabama, and Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama; Department of Rehabilitation and Movement Science, College of Nursing and Health Sciences, University of Vermont, Burlington, Vermont; University of Washington, Seattle, Washington, USA; Swiss Paraplegic Research, Nottwil, Switzerland; Université de Lorraine, EA 4360 Approches Épidémiologiques et Psychologiques (APEMAC), Nancy, France; University of Florence, Florence, Italy; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; European Medicines Agency, London, UK; Faculty of Medicine and Health University of Sydney and Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.

Objective: The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT.

Methods: During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors.

Results: A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important.

Conclusion: The identified important contextual factor domains may be considered a provisional list pending further research.
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http://dx.doi.org/10.3899/jrheum.181081DOI Listing
September 2019

Ultrasound pathology of the entheses in an age and gender stratified sample of healthy adult subjects: a prospective cross-sectional frequency study.

Clin Exp Rheumatol 2019 May-Jun;37(3):408-413. Epub 2018 Dec 19.

The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.

Objectives: Ultrasound (US) examination of the entheses is increasingly used. However, little is known about US findings in the entheses in asymptomatic persons. The aim of this study was to investigate the appearance of US signs in the enthuses of the lower limb in asymptomatic subjects.

Methods: We recruited 64 subjects, eight women and eight men whose ages covered four decades, from 20 to 60 years. None had tendon or joint disease in the lower limbs. Participants were examined by a rheumatologist and blood samples were collected to rule out enthesis pathology. The enthesis of the dominant leg were examined with grey-scale and Doppler US to evaluate increased thickness, changed structure, enthesophytes/calcifications, erosions, and colour Doppler signal.

Results: Ultrasound examination of 320 entheses was made. At enthesis level, elementary lesions were seen at 73 (22.8%) sites, at subject-level 47 (73.4%) persons showed elementary lesions, in 27 (57%) only one enthesis was affected. Doppler activity was seen in four sites, three at the quadriceps insertion. Most common US elementary lesion was enthesophytes at the Achilles and quadriceps tendon insertion. A tendency towards more elementary lesions was seen in men, and a slight increase was seen with increasing age, however, not statistically significance.

Conclusions: Our findings suggest that US can be used to diagnose/examine subjects in adulthood for pathological changes in the entheses; however, caution should be taken regarding enthesophytes of the quadriceps and Achilles tendon.
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May 2019

Applicability of trials in rheumatoid arthritis and osteoarthritis: A systematic review and meta-analysis of trial populations showing adequate proportion of women, but underrepresentation of elderly people.

Semin Arthritis Rheum 2019 06 2;48(6):983-989. Epub 2018 Nov 2.

Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany.

Objectives: To evaluate whether elderly people and women are adequately represented in randomized controlled trials (RCT) in rheumatoid arthritis (RA) and osteoarthritis (OA).

Methods: Four systematic searches in MEDLINE yielded RCT in RA and OA on any intervention published in 2016 and 2017 and population-based studies (PBS) in RA and OA published between 2013 and 2017. Random effects meta-analyses estimated the pooled proportion of elderly people (defined as being ≥ 65 years old), the mean age, its standard deviation (SD), and the proportion of women stratified by disease (RA and OA) and study type (RCT and PBS). Stratified estimates were subsequently compared.

Results: 265 RCT comprising 51,240 participants and 53 PBS comprising 523,630 participants were included. In both RA and OA, RCT included lower proportions of elderly people than PBS: RA -0.18 (95% confidence interval -0.22 to -0.13); OA -0.20 (-0.30 to -0.09); had lower mean ages: RA -5.2 years (-6.8 to -3.5); OA -4.7 years (-7.5 to -2.0); and smaller SD: RA -1.9 years (-2.6 to -1.3); OA -2.7 years (-4.2 to -1.2); (all comparisons: p ≤ 0.001). Proportions of women were comparable in RCT compared to PBS in both RA and OA.

Conclusions: While women are adequately represented in RA and OA trials, the elderly are underrepresented, probably limiting applicability of current evidence to this growing subgroup. It is urgent to improve the inclusion of elderly people in clinical trials and study age as a determinant for outcome.
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http://dx.doi.org/10.1016/j.semarthrit.2018.10.017DOI Listing
June 2019

In vivo differentiation of common basal cell carcinoma subtypes by microvascular and structural imaging using dynamic optical coherence tomography.

Exp Dermatol 2018 02 10;27(2):156-165. Epub 2018 Jan 10.

Department of Dermatology, Zealand University Hospital, Roskilde, Denmark.

The subtype of basal cell carcinoma (BCC) influences the choice of treatment. Optical coherence tomography (OCT) is a non-invasive imaging tool, and a recent development of an angiographic version of OCT has extended the application of OCT to image the cutaneous microvasculature (so-called dynamic OCT, D-OCT). This study explores D-OCT's ability to differentiate the common BCC subtypes by microvascular and structural imaging. Eighty-one patients with 98 BCC lesions, consisting of three subtypes: 27 superficial BCC (sBCC), 55 nodular BCC (nBCC) and 16 infiltrative BCC (iBCC) were D-OCT scanned at three European dermatology centres. Blinded evaluations of microvascular and structural features were performed, followed by extensive statistical analysis of risk ratio (RR) and multiple correspondence analysis. nBCC lesions displayed most characteristic structural and vascular features. Serpiginous vessels, branching vessels, vessels creating a circumscribed figure and sharply demarcated hyporeflective ovoid structures in the dermis were all associated with a higher risk of the subtype being nBCC. The presence of highly present lines and dark peripheral borders at the margin of ovoid structures was negatively associated with iBCC. Lastly, the finding of hyporeflective ovoid structures protruding from epidermis correlated with sBCC. We identified various microvascular and structural D-OCT features that may aid non-invasive identification of BCC subtypes. This would allow clinicians to individualize and optimize BCC treatment as well as aid follow-up of non-surgical treatment.
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http://dx.doi.org/10.1111/exd.13479DOI Listing
February 2018

Weight loss for overweight and obese individuals with gout: a systematic review of longitudinal studies.

Ann Rheum Dis 2017 Nov 2;76(11):1870-1882. Epub 2017 Sep 2.

The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Objectives: Weight loss is commonly recommended for gout, but the magnitude of the effect has not been evaluated in a systematic review. The aim of this systematic review was to determine benefits and harms associated with weight loss in overweight and obese patients with gout.

Methods: We searched six databases for longitudinal studies, reporting the effect of weight loss in overweight/obese gout patients. Risk of bias was assessed using the tool Risk of Bias in Non-Randomised Studies of Interventions. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation.

Results: From 3991 potentially eligible studies, 10 were included (including one randomised trial). Interventions included diet with/without physical activity, bariatric surgery, diuretics, metformin or no intervention. Mean weight losses ranged from 3 kg to 34 kg. Clinical heterogeneity in study characteristics precluded meta-analysis. The effect on serum uric acid (sUA) ranged from -168 to 30 μmol/L, and 0%-60% patients achieving sUA target (<360 μmol/L). Six out of eight studies (75%) showed beneficial effects on gout attacks. Two studies indicated dose-response relationship for sUA, achieving sUA target and gout attacks. At short term, temporary increased sUA and gout attacks tended to occur after bariatric surgery.

Conclusions: The available evidence is in favour of weight loss for overweight/obese gout patients, with low, moderate and low quality of evidence for effects on sUA, achieving sUA target and gout attacks, respectively. At short term, unfavourable effects may occur. Since the current evidence consists of a few studies (mostly observational) of low methodological quality, there is an urgent need to initiate rigorous prospective studies (preferably randomised controlled trials).

Systematic Review Registration: PROSPERO, CRD42016037937.
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http://dx.doi.org/10.1136/annrheumdis-2017-211472DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5705854PMC
November 2017

An OMERACT Initiative Toward Consensus to Identify and Characterize Candidate Contextual Factors: Report from the Contextual Factors Working Group.

J Rheumatol 2017 Nov 1;44(11):1734-1739. Epub 2017 May 1.

From the Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre; CAPHRI Research Institute, Maastricht University, Maastricht; Department of Psychology, Health and Technology, University of Twente, Enschede; Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles; Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, and Healthy Motivation, Santa Barbara, California; Department of Rehabilitation and Movement Science, The University of Vermont, Burlington, Vermont, USA; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Faculty of Health and Applied Sciences, University of the West of England, Bristol; Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK; Division of Rheumatology, Department of Medicine, University of Ottawa and Ottawa Hospital; Centre for Global Health, Institute of Population Health, University of Ottawa and Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa; Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital; Institute for Work and Health, and Institute of Health Policy, Management and Evaluation, Rehabilitation Sciences Institute, and Departments of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada; Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany; University of Lorraine, EA 4360 APEMAC, Nancy, France; Institute of Bone and Joint Research, University of Sydney; Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Sydney; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia.

Objective: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome assessment and defined them as "potential confounders and/or effect modifiers of outcomes in randomized controlled trials." Subsequently, the CF Methods Group (CFMG) was formed to develop guidance on how to address CF in clinical trials.

Methods: First, the CFMG conducted an e-mail survey of OMERACT working groups (WG) to analyze how they had addressed CF in outcome measurement so far. The results facilitated an informed discussion at the OMERACT 2016 CFMG Special Interest Group (SIG) session, with the aim of gaining preliminary consensus regarding an operational definition of CF and to make a first selection of potentially relevant CF.

Results: The survey revealed that the WG had mostly used the OMERACT Handbook and/or the International Classification of Functioning, Disability and Health (ICF) definition. However, significant heterogeneity was found in the methods used to identify, refine, and categorize CF candidates. The SIG participants agreed on using the ICF as a framework along with the OMERACT Handbook definition. A list with 28 variables was collected including person-related factors and physical and social environments. Recommendations from the SIG guided the CFMG to formulate 3 preliminary projects on how to identify and analyze CF.

Conclusion: New methods are urgently needed to assist researchers to identify and characterize CF that significantly influence the interpretation of results in clinical trials. The CFMG defined first steps to develop further guidance.
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http://dx.doi.org/10.3899/jrheum.161200DOI Listing
November 2017

Marine Oil Supplements for Arthritis Pain: A Systematic Review and Meta-Analysis of Randomized Trials.

Nutrients 2017 Jan 6;9(1). Epub 2017 Jan 6.

Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000 Copenhagen F, Denmark.

Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched systematically (24 February 2015). We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML)-based meta-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD) suggested a favorable effect (-0.24; 95% confidence interval, CI, -0.42 to -0.07; heterogeneity, ² = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; -0.21; 95% CI, -0.42 to -0.004) and other or mixed diagnoses (3 trials; -0.63; 95% CI, -1.20 to -0.06), but not in osteoarthritis patients (5 trials; -0.17; 95% CI, -0.57-0.24). The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.
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http://dx.doi.org/10.3390/nu9010042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5295086PMC
January 2017