Published in 2021

Effectiveness of a Second Biologic After Failure of a Non-tumor Necrosis Factor Inhibitor As First Biologic in Rheumatoid Arthritis

Chatzidionysiou, K., Hetland, M. L., Frisell, T., Di Giuseppe, D., Hellgren, K., Glintborg, B., Nordström, D., Peltomaa, R., Aaltonen, K., Trokovic, N., Kristianslund, E. K., Kvien, T. K., Provan, S. A., Gudbjornsson, B., Grondal, G., Dreyer, L., Kristensen, L. E., Jørgensen, T. S., Jacobsson, L. T. H. & Askling, J., okt. 2021, I: Journal of Rheumatology. 48, 10, s. 1512-1518 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: In rheumatoid arthritis (RA), evidence regarding the effectiveness of a second biologic disease-modifying antirheumatic drug (bDMARD) in patients whose first-ever bDMARD was a non-tumor necrosis factor inhibitor (TNFi) bDMARD is limited. The objective of this study was therefore to assess the outcome of a second bDMARD (non-TNFi: rituximab [RTX], abatacept [ABA], or tocilizumab [TCZ], separately; and TNFi) after failure of a non-TNFi bDMARD as first bDMARD.

METHODS: We identified patients with RA from the 5 Nordic biologics registers who started treatment with a non-TNFi as first-ever bDMARD but switched to a second bDMARD. For the second bDMARD, we assessed drug survival (at 6 and 12 months) and primary response (at 6 months).

RESULTS: We included 620 patients starting a second bDMARD (ABA 86, RTX 40, TCZ 67, and TNFi 427) following failure of a first non-TNFi bDMARD. At 6 and 12 months after start of their second bDMARD, approximately 70% and 60%, respectively, remained on treatment, and at 6 months, less than one-third of patients were still on their second bDMARD and had reached low disease activity or remission according to the Disease Activity Score in 28 joints. For those patients whose second bMDARD was a TNFi, the corresponding proportion was slightly higher (40%).

CONCLUSION: The drug survival and primary response of a second bDMARD in patients with RA switching due to failure of a non-TNFi bDMARD as first bDMARD is modest. Some patients may benefit from TNFi when used after failure of a non-TNFi as first bDMARD.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 48
Udgave nummer 10
Sider (fra-til) 1512-1518
Antal sider 7
ISSN 0315-162X
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 by the Journal of Rheumatology.

Effectiveness of interdisciplinary combined dermatology-gastroenterology-rheumatology clinical care compared to usual care in patients with immune-mediated inflammatory diseases: a parallel group, non-blinded, pragmatic randomised trial

Hjuler, K. F., Dige, A., Agnholt, J., Laurberg, T. B., Loft, A. G., Møller, L. F., Christensen, R. & Iversen, L., 28 apr. 2021, I: BMJ Open. 11, 4, s. e041871 e041871.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Artikelnummer e041871
Tidsskrift BMJ Open
Vol/bind 11
Udgave nummer 4
Sider (fra-til) e041871
ISSN 2044-6055
DOI
Status Udgivet - 28 apr. 2021

Effectiveness of Mind-Body Intervention for Inflammatory Conditions: Results from a 26-Week Randomized, Non-Blinded, Parallel-Group Trial

Nguyen, T. T., Jensen, C. G., Khoury, L., Deleuran, B., Blom, E. S., Breinholt, T., Christensen, R. & Skov, L., 14 jul. 2021, I: Journal of Clinical Medicine. 10, 14, 3107.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Biopsychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions. We compared the effect of a mind-body intervention (MBI), relative to treatment-as-usual (TAU) on WHO-5 Well-being Index during an intensive period of 12 weeks and follow-up at week 26 among patients with either psoriasis (PsO) or rheumatoid arthritis (RA). The MBI was based on the 'Relaxation Response Resiliency Program' and the 'Open and Calm Program', as well as 'Mindfulness Based Stress Reduction' (MBSR). The trial was randomized, management-as-usual, and controlled. Statistical analyses were based on the intention-to-treat population using repeated measures and mixed effects models (NCT03888261). We screened 39 potential participants, 35 of which (PsO, n = 20; RA, n = 15) met the eligibility criteria and were randomized: 17 in the MBI group and 18 in the TAU group. Attrition from the intervention program was 19%, with 65% of MBI patients and 71% of TAU patients completing the outcome assessments. After 12 weeks, a statistically significant difference in WHO-5 was observed between the groups (p = 0.019). However, according to the protocol, during the entire trial period, the average (least squares mean values) WHO-5 score was higher although not statistically significant in the MBI group (65.3) compared with the TAU group (59.1), corresponding to a between-group difference over 26 weeks of 6.15 (95% CI: -0.26 to 12.56; p = 0.060). All things considered, adding biopsychosocial intervention to clinical practice to patients with conditions, such as PsO and RA, could potentially improve health-related quality of life.

Originalsprog Engelsk
Artikelnummer 3107
Tidsskrift Journal of Clinical Medicine
Vol/bind 10
Udgave nummer 14
ISSN 2077-0383
DOI
Status Udgivet - 14 jul. 2021

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

Jeppesen, P., Wolf, R. T., Nielsen, S. M., Christensen, R., Plessen, K. J., Bilenberg, N., Thomsen, P. H., Thastum, M., Neumer, S-P., Puggaard, L. B., Pedersen, M. M. A., Pagsberg, A. K., Silverman, W. K. & Correll, C. U., 1 mar. 2021, I: JAMA Psychiatry. 78, 3, s. 250-260 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift JAMA Psychiatry
Vol/bind 78
Udgave nummer 3
Sider (fra-til) 250-260
Antal sider 11
ISSN 2168-622X
DOI
Status Udgivet - 1 mar. 2021

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).

REGISTRATION: NCT02969135 (ClinicalTrials.gov identifier).

Originalsprog Engelsk
Tidsskrift The American journal of sports medicine
Vol/bind 49
Udgave nummer 2
Sider (fra-til) 321-331
Antal sider 11
ISSN 0363-5465
DOI
Status Udgivet - feb. 2021
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).

Originalsprog Engelsk
Tidsskrift The American journal of sports medicine
ISSN 0363-5465
Status Udgivet - feb. 2021

Effects of a Lifestyle Intervention on Bone Turnover in Persons with Type 2 Diabetes: A post hoc Analysis of the U-TURN Trial

Abildgaard, J., Johansen, M. Y., Skov-Jeppesen, K., Andersen, L. B., Karstoft, K., Hansen, K. B., Hartmann, B., Holst, J. J., Pedersen, B. K. & Ried-Larsen, M., 24 aug. 2021, (E-pub ahead of print) I: Medicine and Science in Sports and Exercise.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION/PURPOSE: The increased risk of fractures with type 2 diabetes (T2D) is suggested to be caused by decreased bone turnover. Current international guidelines recommend lifestyle modifications, including exercise, as first-line treatment for T2D. The aim of this study was to investigate the effects of an exercise-based lifestyle intervention on bone turnover and bone mineral density (BMD) in persons with T2D.

METHODS: Persons with T2D were randomized to either a 12-month lifestyle intervention (n = 64) or standard care (n = 34). The lifestyle intervention included five to six weekly aerobic training sessions, half of them combined with resistance training. Serum markers of bone turnover (osteocalcin, N-terminal propeptide of type-I procollagen, reflecting bone formation, and carboxyterminal collagen I crosslinks, reflecting bone resorption) and BMD (by DXA) were measured before the intervention and at follow-up.

RESULTS: From baseline to follow-up, s-propeptide of type-I procollagen increased by 34% (95% confidence interval [CI], 17%-50%), serum-carboxyterminal collagen I crosslink by 36% (95% CI, 1%-71%), and s-osteocalcin by 31% (95% CI, 11-51%) more in the lifestyle intervention group compared with standard care. Loss of weight and fat mass were the strongest mediators of the increased bone turnover. Bone mineral density was unaffected by the intervention (ΔBMD, 0.1%; 95% CI, -1.1% to 1.2%).

CONCLUSIONS: A 12-month intensive exercise-based lifestyle intervention led to a substantial but balanced increase in bone turnover in persons with T2D. The increased bone turnover combined with a preserved BMD, despite a considerable weight loss, is likely to reflect improved bone health and warrants further studies addressing the impact of exercise on risk of fractures in persons with T2D.

Originalsprog Engelsk
Tidsskrift Medicine and Science in Sports and Exercise
ISSN 0195-9131
DOI
Status E-pub ahead of print - 24 aug. 2021

Effects of triclosan exposure on placental extravillous trophoblast motility, relevant IGF2/H19 signaling and DNA methylation-related enzymes of HTR-8/SVneo cell line

Ma, R., Tang, N., Feng, L., Wang, X., Zhang, J., Ren, X., Du, Y. & Ouyang, F., 25 dec. 2021, I: Ecotoxicology and Environmental Safety. 228, 113051.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Artikelnummer 113051
Tidsskrift Ecotoxicology and Environmental Safety
Vol/bind 228
ISSN 0147-6513
DOI
Status Udgivet - 25 dec. 2021

Bibliografisk note

Funding Information:
This study was supported by grants from the National Natural Science Foundation of China (NSFC, No. 81961128023 ), National Key Research and Development Program of China (No. 2017YFE0124700 ), NSFC (No. 81673178 ), Shanghai Municipal Education Commission—Gaofeng Clinical Medicine Grant ( 20152518 ) and Shanghai Municipal Health Commission ( 2020CXJQ01 , GWV-10.1-XK07 ).

Publisher Copyright:
© 2021

Effects of whey protein and dietary fiber intake on insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite in subjects with abdominal obesity

Fuglsang-Nielsen, R., Rakvaag, E., Langdahl, B., Knudsen, K. E. B., Hartmann, B., Holst, J. J., Hermansen, K. & Gregersen, S., apr. 2021, I: European Journal of Clinical Nutrition. 75, 4, s. 611-619 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Recently, we demonstrated that whey protein (WP) combined with low dietary fiber improved lipemia, a risk factor for cardiovascular disease in subjects with abdominal obesity. In the present study, we investigated the effects of intake of WP and dietary fiber from enzyme-treated wheat bran on other metabolic parameters of the metabolic syndrome.

METHODS: The study was a 12-week, double-blind, randomized, controlled, parallel intervention study. We randomized 73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions: 60 g per day of either WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30 g dietary fiber/day) or low-fiber (LoFi; 10 g dietary fiber/day) cereal products. We assessed changes in insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite.

RESULTS: Sixty-five subjects completed the trial. Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02). We found no effects on ratings of satiety, fullness or prospective food consumption for either of the interventions. Intake of WP combined with LoFi increased the postprandial peptide YY response. There were no effects of WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP.

CONCLUSIONS: WP consumption for 12 weeks reduced subjective ratings of hunger in subjects with abdominal obesity. Neither WP nor dietary fiber from wheat bran affected insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure compared with MD and low dietary fiber.

Originalsprog Engelsk
Tidsskrift European Journal of Clinical Nutrition
Vol/bind 75
Udgave nummer 4
Sider (fra-til) 611-619
Antal sider 9
ISSN 0954-3007
DOI
Status Udgivet - apr. 2021

Efficacy and safety of intra-articular therapies in rheumatic and musculoskeletal diseases: an overview of systematic reviews

Rodriguez-García, S. C., Castellanos-Moreira, R., Uson, J., Naredo, E., O'Neill, T. W., Doherty, M., Boesen, M., Pandit, H., Möller Parera, I., Vardanyan, V., Terslev, L., Kampen, W. U., D'Agostino, M. A., Berenbaum, F., Nikiphorou, E., Pitsillidou, I., de la Torre-Aboki, J. & Carmona, L., jun. 2021, I: RMD Open. 7, 2, 001658.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Artikelnummer 001658
Tidsskrift RMD Open
Vol/bind 7
Udgave nummer 2
ISSN 2056-5933
DOI
Status Udgivet - jun. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Efficacy and Safety of Polyunsaturated Fatty Acids Supplementation in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents: A Systematic Review and Meta-Analysis of Clinical Trials

Händel, M. N., Rohde, J. F., Rimestad, M. L., Bandak, E., Birkefoss, K., Tendal, B., Lemcke, S. & Callesen, H. E., 8 apr. 2021, I: Nutrients. 13, 4, 1226.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Based on epidemiological and animal studies, the rationale for using polyunsaturated fatty acids (PUFAs) as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) seems promising. Here, the objective was to systematically identify and critically assess the evidence from clinical trials. The primary outcome was ADHD core symptoms. The secondary outcomes were behavioral difficulties, quality of life, and side effects. We performed a systematic search in Medline, Embase, Cinahl, PsycInfo, and the Cochrane Library up to June 2020. The overall certainty of evidence was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE). We identified 31 relevant randomized controlled trials including 1755 patients. The results showed no effect on ADHD core symptoms rated by parents (k = 23; SMD: -0.17; 95% CI: -0.32, -0.02) or teachers (k = 10; SMD: -0.06; 95% CI: -0.31, 0.19). There was no effect on behavioral difficulties, rated by parents (k = 7; SMD: -0.02; 95% CI: -0.17, 0.14) or teachers (k = 5; SMD: -0.04; 95% CI: -0.35, 0.26). There was no effect on quality of life (SMD: 0.01; 95% CI: -0.29, 0.31). PUFA did not increase the occurrence of side effects. For now, there seems to be no benefit of PUFA in ADHD treatment; however, the certainty of evidence is questionable, and thus no conclusive guidance can be made. The protocol is registered in PROSPERO ID: CRD42020158453.

Originalsprog Engelsk
Artikelnummer 1226
Tidsskrift Nutrients
Vol/bind 13
Udgave nummer 4
ISSN 2072-6643
DOI
Status Udgivet - 8 apr. 2021

Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach

Toupin-April, K., Décary, S., de Wit, M., Meara, A., Barton, J. L., Fraenkel, L., Li, L. C., Brooks, P., Shea, B., Stacey, D., Légaré, F., Lydiatt, A., Hofstetter, C., Proulx, L., Christensen, R., Voshaar, M., Suarez-Almazor, M. E., Boonen, A., Meade, T., March, L., Jull, J. E., Campbell, W., Alten, R., Morgan, E. M., Kelly, A., Kaufman, J., Hill, S., Maxwell, L. J., Guillemin, F., Beaton, D., El-Miedany, Y., Mittoo, S., Westrich Robertson, T., Bartlett, S. J., Singh, J. A., Mannion, M., Nasef, S. I., de Souza, S., Boel, A., Adebajo, A., Arnaud, L., Gill, T. K., Moholt, E., Burt, J., Jayatilleke, A., Hmamouchi, I., Carrott, D., Blanco, F. J., Mather, K., Maharaj, A., Sharma, S., Caso, F., Fong, C., Fernandez, A. P., Mackie, S., Nikiphorou, E., Jones, A., Greer-Smith, R., Sloan, V. S., Akpabio, A., Strand, V., Umaefulam, V., Monti, S., Melburn, C., Abaza, N., Schultz, K., Stones, S., Kiwalkar, S., Srinivasalu, H., Constien, D., King, L. K. & Tugwell, P., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 593-600 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 593-600
Antal sider 8
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

Establishing research priorities related to osteoarthritis care via stakeholder input from patients

Puggaard, R. S., Ingelsrud, L. H., Jacobsen, S., Kjellberg, J., Bandholm, T., Hölmich, P., Boesen, M., Bliddal, H., Skou, S. T., Schrøder, H. M., Larsen, S. W., Møller, A., Ziegler, C. & Troelsen, A., 2021, I: Danish Medical Journal. 68, 2, s. 1-8 8 s., A09200683.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Stakeholder involvement in research is emphasised to improve relevance. We aimed to identify, define and prioritise important research topics seen from the point of view of people with osteoarthritis (OA).

METHODS: We invited 1,315 members of the user panel of the Danish Rheumatism Association to answer an electronic survey that included; 1) an open-ended question about important research topics (free-text response option), 2) 15 predefined research topics to be rated for importance and 3) predefined topics grouped into four categories in which the most important was prioritised. Free-text responses were analysed using content analysis.

RESULTS: Out of 850 (65%) respondents, 483 had OA (mean ± standard deviation age 60.3 ± 10.2 years, 91% female). From the free-text responses, we identified seven research topics; 1) diagnostics, 2) prevention, 3) side effects, 4) treatment, 5) aetiology, 6) being young with OA and 7) quality of life. For "treatment", we identified seven subtopics. Out of all topics and subtopics, "pain management" was the most frequently highlighted. All predefined topics were rated as "very important" or "somewhat important" by more than 75% of the respondents. The top prioritised topics within each category were 1) improving the diagnosis, 2) individualised treatment, 3) shared decision-making and 4) cross-sector collaboration and collaboration between professionals.

CONCLUSIONS: We identified research topics that were important in the eyes of people with OA and found that "pain management" was particularly emphasised.

FUNDING: none.

TRIAL REGISTRATION: not relevant.

Originalsprog Engelsk
Artikelnummer A09200683
Tidsskrift Danish Medical Journal
Vol/bind 68
Udgave nummer 2
Sider (fra-til) 1-8
Antal sider 8
ISSN 1603-9629
Status Udgivet - 2021

Bibliografisk note

Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

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.

Originalsprog Engelsk
Artikelnummer 668
Tidsskrift Journal of Clinical Medicine
Vol/bind 10
Udgave nummer 4
Antal sider 18
ISSN 2077-0383
DOI
Status Udgivet - 9 feb. 2021

EULAR recommendations for intra-articular therapies

Uson, J., Rodriguez-García, S. C., Castellanos-Moreira, R., O'Neill, T. W., Doherty, M., Boesen, M., Pandit, H., Möller Parera, I., Vardanyan, V., Terslev, L., Kampen, W. U., D'Agostino, M-A., Berenbaum, F., Nikiphorou, E., Pitsillidou, I. A., de la Torre-Aboki, J., Carmona, L. & Naredo, E., okt. 2021, I: Annals of the Rheumatic Diseases. 80, 10, s. 1299-1305 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To establish evidence-based recommendations to guide health professionals using intra-articular therapies (IAT) in adult patients with peripheral arthropathies.

METHODS: A multidisciplinary international task force established the objectives, users and scope and the need for background information, including systematic literature reviews) and two surveys addressed to healthcare providers and patients throughout Europe. The evidence was discussed in a face-to-face meeting, recommendations were formulated and subsequently voted for anonymously in a three-round Delphi process to obtain the final agreement. The level of evidence was assigned to each recommendation with the Oxford levels of evidence.

RESULTS: Recommendations focus on practical aspects to guide health professionals before, during and after IAT in adult patients with peripheral arthropathies. Five overarching principles and 11 recommendations were established, addressing issues related to patient information, procedure and setting, accuracy, routine and special aseptic care, safety issues and precautions to be addressed in special populations, efficacy and safety of repeated joint injections, use of local anaesthetics and aftercare.

CONCLUSION: We have developed the first evidence and expert opinion-based recommendations to guide health professionals using IAT. We hope that these recommendations will be included in different educational programmes, used by patient associations and put into practice via scientific societies to help improve uniformity and quality of care when performing IAT in peripheral adult joints.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 80
Udgave nummer 10
Sider (fra-til) 1299-1305
Antal sider 7
ISSN 0003-4967
DOI
Status Udgivet - okt. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

EULAR recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs)

Costantino, F., Carmona, L., Boers, M., Backhaus, M., Balint, P. V., Bruyn, G. A., Christensen, R., Conaghan, P. G., Ferreira, R. J. O., Garrido-Castro, J. L., Guillemin, F., Hammer, H. B., van der Heijde, D., Iagnocco, A., Kortekaas, M. C., Landewé, R. B., Mandl, P., Naredo, E., Schmidt, W. A., Terslev, L., Terwee, C. B., Thiele, R. & D'Agostino, M-A., jul. 2021, I: Annals of the Rheumatic Diseases. 80, 7, s. 840-847 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 80
Udgave nummer 7
Sider (fra-til) 840-847
Antal sider 8
ISSN 0003-4967
DOI
Status Udgivet - jul. 2021

Evaluating a complex intervention addressing ability to perform activities of daily living among persons with chronic conditions: Study protocol for a randomised controlled trial (ABLE)

Hagelskjær, V., Nielsen, K. T., von Bulow, C., Oestergaard, L. G., Graff, M. & Wæhrens, E. E., 26 nov. 2021, I: BMJ Open. 11, 11, s. e051722 :e051722.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: The need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council's guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme.

METHODS AND ANALYSIS: The evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers.

ETHICS AND DISSEMINATION: Danish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences.

TRIAL REGISTRATION NUMBER: NCT04295837.

Originalsprog Engelsk
Artikelnummer :e051722
Tidsskrift BMJ Open
Vol/bind 11
Udgave nummer 11
Sider (fra-til) e051722
ISSN 2044-6055
DOI
Status Udgivet - 26 nov. 2021

Bibliografisk note

Funding Information:
Funding This work was supported by: The Oak Foundation (OCAY-13-309); The municipal fund for quality development (A327); VIA University College; Southern Denmark University; Bispebjerg and Frederiksberg Hospital, University of Copenhagen; Research Fund of the Danish Association of Occupational Therapy (FF1/19-R112-A2271 and FF2/19-R132-A2835); and the Lundbeck foundation (A8059).

Publisher Copyright:
© 2021 BioMed Central Ltd.. All rights reserved.

Evidence-Based Digital Tools for Weight Loss Maintenance: The NoHoW Project

Stubbs, R. J., Duarte, C., Palmeira, A. L., Sniehotta, F. F., Horgan, G., Larsen, S. C., Marques, M. M., Evans, E. H., Ermes, M., Harjumaa, M., Turicchi, J., O'Driscoll, R., Scott, S. E., Pearson, B., Ramsey, L., Mattila, E., Matos, M., Sacher, P., Woodward, E., Mikkelsen, M-L., Sainsbury, K., Santos, I., Encantado, J., Stalker, C., Teixeira, P. J. & Heitmann, B. L., 2021, I: Obesity Facts. 14, 3, s. 320-333 14 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Obesity Facts
Vol/bind 14
Udgave nummer 3
Sider (fra-til) 320-333
Antal sider 14
ISSN 1662-4025
DOI
Status Udgivet - 2021

Evidence-Based Research Series-Paper 1: What Evidence-Based Research is and why is it important?

Robinson, K. A., Brunnhuber, K., Ciliska, D., Juhl, C. B., Christensen, R. & Lund, H., jan. 2021, I: Journal of Clinical Epidemiology. 129, s. 151-157 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: There is considerable actual and potential waste in research. Evidence-based research ensures worthwhile and valuable research. The aim of this series, which this article introduces, is to describe the evidence-based research approach.

STUDY DESIGN AND SETTING: In this first article of a three-article series, we introduce the evidence-based research approach. Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner.

RESULTS: We describe evidence-based research and provide an overview of the approach of systematically and transparently using previous research before starting a new study to justify and design the new study (article #2 in series) and-on study completion-place its results in the context with what is already known (article #3 in series).

CONCLUSION: This series introduces evidence-based research as an approach to minimize unnecessary and irrelevant clinical health research that is unscientific, wasteful, and unethical.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 129
Sider (fra-til) 151-157
Antal sider 7
ISSN 0895-4356
DOI
Status Udgivet - jan. 2021

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Evidence-Based Research Series-Paper 2: Using an Evidence-Based Research approach before a new study is conducted to ensure value

Evidence-Based Research Network, jan. 2021, I: Journal of Clinical Epidemiology. 129, s. 158-166 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background and Objectives: There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value. Study Design and Setting: Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study. Results: Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies. Conclusion: Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 129
Sider (fra-til) 158-166
Antal sider 9
ISSN 0895-4356
DOI
Status Udgivet - jan. 2021

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Pages