Published in 2019

Current state of evidence for endolymphatic sac surgery in Menière's disease: a systematic review

Devantier, L., Schmidt, J. H., Djurhuus, B. D., Hougaard, D. D., Händel, M. N., Liviu-Adelin Guldfred, F. & Edemann-Callesen, H., nov. 2019, I : Acta Oto-Laryngologica. 139, 11, s. 953-958 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Endolymphatic sac surgery is an invasive procedure recommended to patients with Menière's disease. Aims/Objectives: To provide an overview and quality assessment of the existing evidence and to provide an updated assessment of the utility of endolymphatic sac surgery in Menière's disease. Material and Methods: We performed a systematic literature search for systematic reviews and randomized controlled trials (RCTs). The AMSTAR tool was used to assess the quality of systematic reviews and the Cochrane risk of bias tool for RCTs. The overall certainty of effects for the individual outcomes was evaluated using the GRADE approach. Results: One systematic review of high quality matched the inclusion criteria, and included three RCTs. An updated literature search from the last search date of the included review provided no further relevant RCTs. The identified RCTs individually reported a positive effect of both the placebo and active treatment groups following surgery, strongly indicative of a placebo effect. The overall certainty of the effect was very low. Conclusions and significance: There is still a lack of high-quality research suggesting that endolymphatic sac surgery provides a significant amount of symptomatic relief for Menière's patients.

Originalsprog Engelsk
Tidsskrift Acta Oto-Laryngologica
Vol/bind 139
Udgave nummer 11
Sider (fra-til) 953-958
Antal sider 6
ISSN 0001-6489
DOI
Status Udgivet - nov. 2019

Development of HiSQOL: A Hidradenitis Suppurativa-Specific Quality of Life Instrument

Thorlacius, L., Esmann, S., Miller, I., Vinding, G. & Jemec, G. B. E., jun. 2019, I : Skin appendage disorders. 5, 4, s. 221-229 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Hidradenitis suppurativa (HS) is a chronic and painful skin disease. In addition, HS lesions may be associated with pus and odour, potentially leading to significant stigma and, consequently, greatly affected quality of life (QOL). QOL is a multidimensional construct, which can be measured in various ways. However, generic or dermatologic QOL measures may not capture changes in QOL particularly affected in HS. Accordingly, patients and experts included in the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) agreed that future clinical HS trials should measure HS-specific QOL.

Objectives: To develop an HS-specific QOL instrument (HiSQOL, Hidradenitis Suppurativa Quality of life).

Method: The initial phases of the questionnaire development, described in this study, included item generation by patient interviews, development of a pilot questionnaire, questionnaire refinement, and pilot testing.

Results: For item generation, 21 patients were interviewed individually or in focus groups. Analysis of the interviews identified 105 candidate items and, next, a pilot questionnaire was developed. Finally, item reduction and two rounds of pilot testing resulted in a 23-item questionnaire representing physical, psychological, and social QOL dimensions.

Conclusions: We have comprehensively explored on HS's possible effect on the QOL of the affected individuals and identified a 23-item HS-specific QOL questionnaire. The questionnaire proved to be feasible, acceptable, and comprehensible in the second round of pilot testing. With HiSQOL, researchers can measure HS-specific QOL in future clinical trials, potentially enabling them to discover more effective treatment options. It is envisaged, that after thorough validation in a trial setting, a streamlined version of HISQOL may also become available for clinical use in daily practice.

Originalsprog Engelsk
Tidsskrift Skin appendage disorders
Vol/bind 5
Udgave nummer 4
Sider (fra-til) 221-229
Antal sider 9
ISSN 2296-9195
DOI
Status Udgivet - jun. 2019

Objectives: A cohort of routine care RA patients in sustained remission had biological DMARD (bDMARDs) tapered according to a treatment guideline. We studied: the proportion of patients whose bDMARD could be successfully tapered or discontinued; unwanted consequences of tapering/discontinuation; and potential baseline predictors of successful tapering and discontinuation.

Methods: One-hundred-and-forty-three patients (91% receiving TNF inhibitor and 9% a non-TNF inhibitor) with sustained disease activity score (DAS28-CRP)⩽2.6 and no radiographic progression the previous year were included. bDMARD was reduced to two-thirds of standard dose at baseline, half after 16 weeks, and discontinued after 32 weeks. Patients who flared (defined as either DAS28-CRP ⩾ 2.6 and ΔDAS28-CRP ⩾ 1.2 from baseline, or erosive progression on X-ray and/or MRI) stopped tapering and were escalated to the previous dose level.

Results: One-hundred-and-forty-one patients completed 2-year follow-up. At 2 years, 87 patients (62%) had successfully tapered bDMARDs, with 26 (18%) receiving two-thirds of standard dose, 39 (28%) half dose and 22 (16%) having discontinued; and 54 patients (38%) were receiving full dose. ΔDAS28-CRP0-2yrs was 0.1((-0.2)-0.4) (median (interquartile range)) and mean ΔTotal-Sharp-Score0-2yrs was 0.01(1.15)(mean(s.d.)). Radiographic progression was observed in nine patients (7%). Successful tapering was independently predicted by: ⩽1 previous bDMARD, male gender, low baseline MRI combined inflammation score or combined damage score. Negative IgM-RF predicted successful discontinuation.

Conclusion: By implementing a clinical guideline, 62% of RA patients in sustained remission in routine care were successfully tapered, including 16% successfully discontinued at 2 years. Radiographic progression was rare. Maximum one bDMARDs, male gender, and low baseline MRI combined inflammation and combined damage scores were independent predictors for successful tapering.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 58
Tidsskriftsnummer 1
Sider (fra-til) 110-119
ISSN 1462-0324
DOI
Status Udgivet - 2019

Bibliografisk note

COPECARE

BACKGROUND: Occupational medicine seeks to reduce sick leave; however, evidence for an add-on effect to usual care is sparse. The objective of the GOBACK trial was to test whether people with low back pain (LBP) in physically demanding jobs and at risk of sick leave gain additional benefit from a 3-month complex intervention that involves occupational medicine consultations, a work-related evaluation and workplace intervention plan, an optional workplace visit, and a physical activity program, over a single hospital consultation and an MRI.

METHODS AND FINDINGS: We enrolled people from the capital region of Denmark to an open-label, parallel-group randomized controlled trial with a superiority design from March 2014 through December 2015. In a hospital setting 305 participants (99 women) with LBP and in physically demanding jobs were randomized to occupational intervention (n = 153) or no additional intervention (control group; n = 152) added to a single hospital consultation giving a thorough explanation of the pain (i.e., clinical examination and MRI) and instructions to stay active and continue working. Primary outcome was accumulated sick leave days due to LBP during 6 months. Secondary outcomes were changes in neuropathic pain (painDETECT questionnaire [PDQ]), pain 0-10 numerical rating scale (NRS), Fear-Avoidance Beliefs Questionnaire (FABQ), Roland-Morris Disability Questionnaire (RMDQ), Short Form Health Survey (SF-36) for physical and mental health-related quality of life (HRQoL), and self-assessed ability to continue working (range 0-10). An intention-to-treat analysis of sick leave at 6 months showed no significant difference between groups (mean difference in days suggestively in favor of no additional intervention: 3.50 [95% CI -5.08 to 12.07], P = 0.42). Both groups showed significant improvements in average pain score (NRS), disability (RMDQ), fear-avoidance beliefs about physical activities and work (FABQ), and physical HRQoL (SF-36 physical component summary); there were no significant differences between the groups in any secondary outcome. There was no statistically significant improvement in neuropathic pain (PDQ score), mental HRQoL (SF-36 mental component summary), and self-assessed ability to stay in job. Four participants could not complete the MRI or the intervention due to a claustrophobic attack or accentuated back pain. Workplace visits may be an important element in the occupational intervention, although not always needed. A per-protocol analysis that included the 40 participants in the intervention arm who received a workplace visit as part of the additional occupational intervention did not show an add-on benefit in terms of sick leave (available cases after 6 months, mean difference: -0.43 days [95% CI -12.8 to 11.94], P = 0.945). The main limitations were the small number of sick leave days taken and that the comprehensive use of MRI may limit generalization of the findings to other settings, for example, general practice.

CONCLUSIONS: When given a single hospital consultation and MRI, people in physically demanding jobs at risk of sick leave due to LBP did not benefit from a complex additional occupational intervention. Occupational interventions aimed at limiting biopsychological obstacles (e.g., fear-avoidance beliefs and behaviors), barriers in the workplace, and system barriers seem essential to reduce sick leave in patients with LBP. This study indicates that these obstacles and barriers may be addressed by thorough usual care.

TRIAL REGISTRATION: Clinical Trials.gov: NCT02015572.

Originalsprog Engelsk
Tidsskrift PLOS Medicine
Vol/bind 16
Udgave nummer 8
Sider (fra-til) e1002898
ISSN 1549-1277
DOI
Status Udgivet - 16 aug. 2019

Effect of Aerobic and Resistance Exercise on Cardiac Adipose Tissues: Secondary Analyses From a Randomized Clinical Trial

Christensen, R. H., Wedell-Neergaard, A-S., Lehrskov, L. L., Legaard, G. E., Dorph, E., Larsen, M. K., Launbo, N., Fagerlind, S. R., Seide, S. K., Nymand, S., Ball, M., Vinum, N. B., Dahl, C. N., Henneberg, M., Ried-Larsen, M., Boesen, M. P., Christensen, R., Karstoft, K., Krogh-Madsen, R., Rosenmeier, J. B., Pedersen, B. K. & Ellingsgaard, H., 3 jul. 2019, I : JAMA Cardiology.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Importance: Epicardial and pericardial adipose tissues are emerging as important risk factors for cardiovascular disease, and there is a growing interest in discovering strategies to reduce the accumulation of fat in these depots.

Objective: To investigate whether a 12-week endurance or resistance training intervention regulates epicardial and pericardial adipose tissue mass.

Design, Setting, and Participants: Secondary analysis of a randomized, assessor-blinded clinical trial initiated on August 2016 and completed April 2018. This single-center, community-based study included 50 physically inactive participants with abdominal obesity.

Interventions: Participants were randomized to a supervised high-intensity interval endurance training (3 times a week for 45 minutes), resistance training (3 times a week for 45 minutes), or no exercise (control group).

Main Outcomes and Measures: Change in epicardial and pericardial adipose tissue mass assessed by magnetic resonance imaging, based on a prespecified secondary analysis plan including 3 of 5 parallel groups.

Results: Of 50 participants (mean [SD] age, 41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study. Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively). While there was a nonsignificant reduction in pericardial adipose tissue mass after endurance training (11% [95% CI, -5% to 27%]; P = .17), resistance training significantly reduced pericardial adipose tissue mass by 31% (95% CI, 16%-47%; P < .001) when compared with the no exercise control group. Compared with the no exercise control group, there was an increase in left ventricular mass by endurance (20 g [95% CI, 11%-30%]; P < .001) and resistance training (18 g [95% CI, 8%-28%]; P < .001). Other cardiometabolic outcomes remained unchanged after the 12-week trial period.

Conclusions and Relevance: In individuals with abdominal obesity, both endurance and resistance training reduced epicardial adipose tissue mass, while only resistance training reduced pericardial adipose tissue mass. These data highlight the potential preventive importance of different exercise modalities as means to reduce cardiac fat in individuals with abdominal obesity.

Trial Registration: ClinicalTrials.gov identifier: NCT02901496.

Originalsprog Engelsk
Tidsskrift JAMA Cardiology
ISSN 2380-6583
DOI
Status E-pub ahead of print - 3 jul. 2019

INTRODUCTION: With an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.

METHODS AND ANALYSIS: 150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week -8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.

ETHICS AND DISSEMINATION: The trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.

TRIAL REGISTRATION NUMBERS: 2015-005163-16, NCT02905864, U1111-1171-4970 BASED ON PROTOCOL VERSION: V.6; 30 January 2017, 15:30 hours.

Originalsprog Engelsk
Artikelnummer e024065
Tidsskrift BMJ Open
Vol/bind 9
Udgave nummer 5
Antal sider 12
ISSN 2044-6055
DOI
Status Udgivet - 5 maj 2019

Bibliografisk note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Background: One of the big contributors to physical inactivity in the elderly population is osteoarthritis (OA) of the knee. Digital motivation seems to have a positive effect on individual physical inactivity level, but limited evidence exists on the effects of digital motivation on patients with knee OA.

Objective: To investigate if motivational text messages reduce time spent physically inactive in patients with knee OA.

Method: This study was designed as an unblinded pilot randomised controlled trial, randomising participants equally (1:1) to an intervention group (motivational text messages) or control group (no intervention). Participants were recruited from six physical therapy clinics in Denmark. Inclusion criteria were age ≥ 18, diagnosed with knee OA, owner of a smartphone or tablet, and participating or commencing participation in the GLA:D® program. The primary outcome was time spent physically inactive, measured with a tri-axial accelerometer mounted on the lateral side of the thigh. Data on OA symptoms were obtained using the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

Results: A total of 49 participants were screened, and 38 participants were included and randomised to either the intervention group (n = 19) or the control group (n = 19). No statistically significant difference between the two groups was found in average change of time spent physically inactive (mean difference 13.2 min/day [95% CI - 41.0 to 67.3]; P = 0.63), time spent standing (mean difference 3.0 min/day [95% CI - 22.7 to 28.7]; P = 0.81), or time spent moving (mean difference - 20.4 min/day [95% CI - 63.0 to 22.3]; P = 0.34) nor was there any difference in change between the two groups on KOOS.

Conclusion: Motivational text messages have seemed to have no effect on overall time spent physically inactive.

Trial registration: clinicaltrials.gov, NCT03339011. Registered 9 November 2017.

Originalsprog Engelsk
Tidsskrift Pilot and Feasibility Studies
Vol/bind 5
Sider (fra-til) 112
ISSN 2055-5784
DOI
Status Udgivet - 2019

Elevated faecal calprotectin is linked to worse disease status in axial spondyloarthritis: results from the SPARTAKUS cohort

Olofsson, T., Lindqvist, E., Mogard, E., Andréasson, K., Marsal, J., Geijer, M., Kristensen, L. E. & Wallman, J. K., 1 jul. 2019, I : Rheumatology (Oxford, England). 58, 7, s. 1176-1187 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To examine faecal calprotectin (F-calprotectin) levels and presence of anti-Saccharomyces cerevisiae antibodies (ASCA) and their associations with disease subtype and current status in axial SpA (axSpA).

METHODS: F-calprotectin and ASCA in serum were compared between consecutive patients with a clinical axSpA diagnosis, classified as non-radiographic axSpA (nr-axSpA; n = 40) or AS (n = 90), and with healthy controls (n = 35). Furthermore, standard axSpA outcome measures were compared between axSpA patients (nr-axSpA and AS combined) with elevated vs normal F-calprotectin, ASCA IgA and IgG, respectively.

RESULTS: Elevated F-calprotectin (⩾50 mg/kg) was observed in 27% of nr-axSpA patients, 38% of AS patients and 6% of controls. F-calprotectin was significantly higher in AS vs nr-axSpA [AS: geometric mean 41 (95% CI 32, 54) mg/kg; nr-axSpA: 24 (95% CI 16, 38) mg/kg; P = 0.037], and in each axSpA subtype vs controls. Overall, worse disease activity and physical function scores were observed among axSpA patients with elevated vs normal F-calprotectin levels, with significant differences regarding patient's visual analogue scale for global health, ASDAS using CRP, and BASFI (adjusted for age, sex, NSAID use, anti-rheumatic treatments, and CRP). ASCA titres and seropositivity (⩾10 U/ml) were similar in nr-axSpA (IgA/IgG-seropositivity: 8%/26%) and AS (7%/28%), and clinical outcome measures did not differ between patients with elevated vs normal ASCA IgA or IgG, respectively. Compared with controls (IgA/IgG-seropositivity: 0%/17%), ASCA IgA was significantly higher in both axSpA subtypes, and IgG was significantly higher in the AS group.

CONCLUSION: In patients with axSpA, gut inflammation measured by elevated F-calprotectin is associated with worse disease activity and physical function, and may be a marker of more severe disease.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 58
Udgave nummer 7
Sider (fra-til) 1176-1187
Antal sider 12
ISSN 1462-0324
DOI
Status Udgivet - 1 jul. 2019

Bibliografisk note

© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report

Duarte-García, A., Leung, Y. Y., Coates, L. C., Beaton, D., Christensen, R., Craig, E. T., de Wit, M., Eder, L., Fallon, L., FitzGerald, O., Gladman, D. D., Goel, N., Holland, R., Lindsay, C., Maxwell, L., Mease, P., Orbai, A. M., Shea, B., Strand, V., Veale, D. J., Tillett, W. & Ogdie, A., aug. 2019, I : Journal of Rheumatology. 46, 8, s. 996-1005 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting's approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS).

METHODS: Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS.

RESULTS: OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a "green" endorsement, whereas among the group of other stakeholders, 88% voted for a "green" endorsement.

CONCLUSION: The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 8
Sider (fra-til) 996-1005
Antal sider 10
ISSN 0315-162X
DOI
Status Udgivet - aug. 2019

Evaluation of a technology assisted physical activity intervention among hospitalised patients: A randomised study

Dall, C. H., Andersen, H., Povlsen, T. M. & Henriksen, M., 4 sep. 2019, I : European Journal of Internal Medicine.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Physical inactivity is common during hospitalisation and poses a threat to functional capacity and independency in the elderly.

AIM: We aimed to assess the effect of physical activity measurements with visual feedback about time spent in various activities on the average daily time spent out of bed during hospitalisation.

METHODS: We recorded physical activity during hospitalisation by accelerometers and compared the effect of the visual feedback (intervention) with no feedback (control) on time spent out of bed. Patients admitted to the pulmonary ward were invited and assigned to intervention with feedback or control with no feedback in 6 alternating waves of approximately 18 patients each. The order of feedback/no feedback was randomised at the outset of the study. The visual feedback intervention group was provided with visual feedback of the daily time spent in bed, sitting, standing, and walking. The control group did not receive feedback.

RESULTS: 93 patients completed the study with a median length of stay of 5 days. Across all patients there were no statistically significant group differences in daily time out of bed; however, patients with independent mobility spent 51 minutes (95% CI 0 to 102; P = .049) more out of bed when provided with visual feedback compared to no feedback.

CONCLUSIONS: A simple technology assisted physical activity intervention with visual feedback to encourage mobility was not effective at increasing time spent out of bed among hospitalised patients. With feedback, a subgroup of patients with independent walking abilities increased time out of bed and may benefit from this type of intervention.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01945749.

Originalsprog Engelsk
Tidsskrift European Journal of Internal Medicine
ISSN 0953-6205
DOI
Status E-pub ahead of print - 4 sep. 2019

Bibliografisk note

Copyright © 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Exercise-Induced Changes in Visceral Adipose Tissue Mass Are Regulated by IL-6 Signaling: A Randomized Controlled Trial

Wedell-Neergaard, A-S., Lang Lehrskov, L., Christensen, R. H., Legaard, G. E., Dorph, E., Larsen, M. K., Launbo, N., Fagerlind, S. R., Seide, S. K., Nymand, S., Ball, M., Vinum, N., Dahl, C. N., Henneberg, M., Ried-Larsen, M., Nybing, J. D., Christensen, R., Rosenmeier, J. B., Karstoft, K., Pedersen, B. K., Ellingsgaard, H. & Krogh-Madsen, R., 2 apr. 2019, I : Cell Metabolism. 29, 4, s. 844-855.e3

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Visceral adipose tissue is harmful to metabolic health. Exercise training reduces visceral adipose tissue mass, but the underlying mechanisms are not known. Interleukin-6 (IL-6) stimulates lipolysis and is released from skeletal muscle during exercise. We hypothesized that exercise-induced reductions in visceral adipose tissue mass are mediated by IL-6. In this randomized placebo-controlled trial, we assigned abdominally obese adults to tocilizumab (IL-6 receptor antibody) or placebo during a 12-week intervention with either bicycle exercise or no exercise. While exercise reduced visceral adipose tissue mass, this effect of exercise was abolished in the presence of IL-6 blockade. Changes in body weight and total adipose tissue mass showed similar tendencies, whereas lean body mass did not differ between groups. Also, IL-6 blockade increased cholesterol levels, an effect not reversed by exercise. Thus, IL-6 is required for exercise to reduce visceral adipose tissue mass and emphasizes a potentially important metabolic consequence of IL-6 blockade.

Originalsprog Engelsk
Tidsskrift Cell Metabolism
Vol/bind 29
Udgave nummer 4
Sider (fra-til) 844-855.e3
ISSN 1550-4131
DOI
Status Udgivet - 2 apr. 2019

BACKGROUND: Exercise therapy is recommended for knee osteoarthritis (OA), but the underlying mechanisms of pain relief are not fully understood. The purpose of this study was to explore the effects of exercise on muscle perfusion assessed by dynamic contrast enhanced MRI (DCE-MRI) and its association with changes in pain in patients with knee OA.

METHODS: Exploratory outcome analyses of a randomised controlled study with per-protocol analyses ( ClinicalTrials.gov : NCT01545258) performed at an outpatient clinic at a public hospital in Denmark. We compared 12 weeks of supervised exercise therapy 3 times per week (ET) with a no attention control group (CG). Analyses of covariance (ANCOVA) were used to assess group mean differences in changes from baseline to week 12 in knee muscle perfusion quantified by DCE-MRI, patient-reported pain and function using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, knee extensor and flexor muscle strength tests, and the six-minute walking test (6MWT). Spearman's correlation coefficients were used to determine the correlation between changes in DCE-MRI variables, KOOS, muscle strength, and 6MWT. The potential effect mediation of the DCE-MRI perfusion variables was investigated in a post-hoc mediation analysis.

RESULTS: Of 60 participants randomised with knee osteoarthritis, 33 (ET, n = 16, CG, n = 17) adhered to the protocol and had complete DCE-MRI data. At follow-up, there were significant group differences in muscle perfusion changes and clinically relevant group differences in KOOS pain changes (10.7, 95% CI 3.3 to 18.1, P = 0.006) in favor of ET. There were no significant between-group differences on muscle strength and function. The changes in pain and muscle perfusion were significantly correlated (highest Spearman's rho = 0.42, P = 0.014). The mediation analyses were generally not statistically significant.

CONCLUSION: The pain-reducing effects of a 12-week exercise program are associated with changes in knee muscle perfusion quantified by DCE-MRI in individuals with knee OA, but whether the effects are mediated by muscle perfusion changes remains unclear.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT01545258 , first posted March 6, 2012.

Originalsprog Engelsk
Tidsskrift BMC Musculoskeletal Disorders
Vol/bind 20
Udgave nummer 1
Sider (fra-til) 491
ISSN 1471-2474
DOI
Status Udgivet - 27 okt. 2019

Exposure to Vitamin D Fortification Policy in Prenatal Life and the Risk of Childhood Asthma: Results From the D-Tect Study

Thorsteinsdottir, F., Maslova, E., Jacobsen, R., Frederiksen, P., Keller, A., Backer, V. & Heitmann, B. L., 24 apr. 2019, I : Nutrients. 11, 4

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Prenatal vitamin D insufficiency may be associated with an increased risk of developing childhood asthma. Results from epidemiological studies are conflicting and limited by short follow-up and small sample sizes. The objective of this study was to examine if children born to women exposed to the margarine fortification policy with a small dose of extra vitamin D during pregnancy had a reduced risk of developing asthma until age 9 years, compared to children born to unexposed women. The termination of a Danish mandatory vitamin D fortification policy constituted the basis for the study design. We compared the risk of inpatient asthma diagnoses in all Danish children born two years before (n = 106,347, exposed) and two years after (n = 115,900, unexposed) the termination of the policy. The children were followed in the register from 0-9 years of age. Data were analyzed using Cox proportional hazards regression. The Hazard Ratio for the first inpatient asthma admission among exposed versus unexposed children was 0.96 (95%CI: 0.90-1.04). When stratifying by sex and age, 0-3 years old boys exposed to vitamin D fortification showed a lower asthma risk compared to unexposed boys (HR 0.78, 95%CI: 0.67-0.92). Prenatal exposure to margarine fortification policy with extra vitamin D did not affect the overall risk of developing asthma among children aged 0-9 years but seemed to reduce the risk among 0-3 years old boys. Taking aside study design limitations, this could be explained by different sensitivity to vitamin D from different sex-related asthma phenotypes in children with early onset, and sex differences in lung development or immune responses.

Originalsprog Engelsk
Tidsskrift Nutrients
Vol/bind 11
Udgave nummer 4
ISSN 2072-6643
DOI
Status Udgivet - 24 apr. 2019

Grading lumbar disc degeneration: a comparison between low- and high-field MRI

Hansen, B. B., Ciochon, U. M., Trampedach, C. R., Christensen, A. F., Rasti, Z. & Boesen, M., 19 apr. 2019, I : Acta Radiologica. s. 284185119842472

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: More advanced disc degeneration on magnetic resonance imaging (MRI) is found in individuals with low back pain. However, it is unclear whether this grading is independent of the scanner's field strength.

PURPOSE: To compare disc degeneration on high- versus low-field MRI.

MATERIAL AND METHODS: Low back pain patients were enrolled to undergo high-field (3 T) MRI, followed by low-field (0.25 T) MRI of the lumbar spine within 3 h. Three radiologists graded the disc degeneration on Pfirrmann's grading scale with a hiatus of 3 months. A subsample was regraded 6 months later. Reproducibility was measured by weighted kappa statistics (using PROC FREQ statement with AGREE in the TABLES statement for SAS), absolute agreement (i.e. 1:1 agreement/the total number) and the difference in the prevalence (McNemar test).

RESULTS: Moderate to substantial agreement (κ = 0.52-0.62) and absolute agreement of 43.8-66.1% were found between field strengths. Low-field MRI tended to have numerically higher and lower grades than high-field MRI resulting in a significant difference in the prevalence of grades ( p < 0.001). Both field strengths resulted in a moderate to substantial inter-reader agreement (low-field: κ = 0.63, 0.63, 0.54 and high-field: κ = 0.55, 0.43, 0.53) and intra-reader agreement (high-field: κ = 0.57, 0.77, 0.67 and low-field: κ = 0.51, 0.50, 0.70). Only, the reader with the shortest experience had better agreement with high-field compared to low-field.

CONCLUSIONS: There were a significant difference in the prevalence of disc degeneration grading between 0.25 T and 3 T MRI. Therefore, field strength should be taken into consideration when comparing studies using disc degeneration grading as an outcome.

Originalsprog Engelsk
Tidsskrift Acta Radiologica
Sider (fra-til) 284185119842472
ISSN 0284-1851
DOI
Status Udgivet - 19 apr. 2019

Hand exercise for women with rheumatoid arthritis and decreased hand function: an exploratory randomized controlled trial

Ellegaard, K., von Bülow, C., Røpke, A., Bartholdy, C., Hansen, I. S., Rifbjerg-Madsen, S., Henriksen, M. & Wæhrens, E. E., 26 jun. 2019, I : Arthritis Research & Therapy. 21, 1, s. 158

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: People with hand-related rheumatoid arthritis (RA) experience problems performing activities of daily living (ADL). Compensatory strategies to improve ADL ability have shown effective. Similarly, hand exercise has shown effect on pain, grip strength, and self-reported ability. A combination has shown positive effects based on self-report, but self-report and observation provide distinct information about ADL. The purpose of this study was to examine whether hand exercise as add on to compensatory intervention (CIP) will improve observed ADL ability in RA.

METHODS: Women (n = 55) with hand-related RA were randomized to CIPEXERCISE (intervention) or CIP only (control). CIP is focused on joint protection, assistive devices, and alternative ways of performing AD. The hand-exercise program addressed range of motion and muscle strength. Primary outcome was change in observed ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS). Baseline measures were repeated after 8 weeks.

RESULTS: Improvements in ADL motor ability in CIPEXERCISE (mean change = 0.24 logits; 95% CI = 0.09 to 0.39) and CIPCONTROL (mean change =0.20 logits; 95% CI = 0.05 to 0.35) were statistically significant, with no differences between groups (mean difference = 0.04 logits; 95% CI = - 0.16 to 0.25). Thirteen (46.4%) participants in the CIPEXERCISE and 12 (44.4%) in the CIPCONTROL obtained clinically relevant improvements (≥ 0.30 logits) in ADL motor ability; this group difference was not significant (z = 0.15; p = 0.88).

CONCLUSION: Adding hand exercise to a compensatory intervention did not yield additional benefits in women with hand-related RA. The study was approved by the ethics committee 14th of April 2014 (H-3-2014-025) and registered at ClinicalTrials.gov 16th of May 2014 (NCT02140866).

Originalsprog Engelsk
Tidsskrift Arthritis Research & Therapy
Vol/bind 21
Udgave nummer 1
Sider (fra-til) 158
ISSN 1478-6354
DOI
Status Udgivet - 26 jun. 2019

Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials

Klokker, L., Berthelsen, D. B., Woodworth, T., Andersen, K. M., Furst, D. E., Devoe, D., Williamson, P. R., Suarez-Almazor, M. E., Strand, V., Leong, A. L., Goel, N., Boers, M., Brooks, P. M., March, L., Sloan, V. S., Tugwell, P., Simon, L. S. & Christensen, R., sep. 2019, I : Journal of Rheumatology. 46, 9, s. 1173-1178 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology.

METHODS: Systematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes.

RESULTS: From 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach.

CONCLUSION: The ideal way to assess harm aspects from the patients' perspective has not yet been ascertained.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 9
Sider (fra-til) 1173-1178
Antal sider 6
ISSN 0315-162X
DOI
Status Udgivet - sep. 2019

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

Contextual Factors Working Group, sep. 2019, I : Journal of Rheumatology. 46, 9, s. 1159-1163 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 9
Sider (fra-til) 1159-1163
Antal sider 5
ISSN 0315-162X
DOI
Status Udgivet - sep. 2019

Identifying, organizing and prioritizing ideas on how to enhance ADL ability

Nielsen, K. T., Klokker, L., Guidetti, S. & Wæhrens, E. E., jul. 2019, I : Scandinavian Journal of Occupational Therapy. 26, 5, s. 382-393 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: There is a need to develop evidence-based occupational therapy programs aiming at enhancing the ability to perform Activities of Daily Living (ADL) among persons living with chronic conditions. Information from different sources is to be integrated in the development process. Thus, it is necessary to engage both occupational therapists and persons living with chronic conditions in suggesting ideas on how to enhance the ADL ability.

OBJECTIVE: To identify, organize and prioritize ideas on how to enhance ability to perform ADL in persons with chronic conditions.

MATERIAL AND METHOD: Group Concept Mapping, involving brainstorming, sorting, labeling, rating and validation of ideas, was applied among persons with chronic conditions (n = ≤ 18) and occupational therapists (n = ≤ 23). Multidimensional scaling analysis and cluster analyzes were applied.

RESULTS: 149 ideas were identified and organized into seven clusters related to applying new adaptational strategies, personal factors, social surroundings and relevant services and opportunities. Each cluster contained ideas of high priority to persons with chronic conditions and/or occupational therapists.

CONCLUSION: A span of highly relevant themes, illustrated the complexity of enhancing ADL ability. This should be considered in the development of interventions aiming at enhancing ADL ability in persons with chronic conditions.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
Vol/bind 26
Udgave nummer 5
Sider (fra-til) 382-393
Antal sider 12
ISSN 1103-8128
DOI
Status Udgivet - jul. 2019

Imaging of Common Rheumatic Joint Diseases Affecting the Upper Limbs

Boesen, M., Roemer, F. W., Østergaard, M., Maas, M., Terslev, L. & Guermazi, A., sep. 2019, I : Radiologic Clinics of North America. 57, 5, s. 1001-1034 34 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Imaging plays an important role in diagnosis and monitoring of rheumatic diseases of the upper limb. Many rheumatic diseases present with similar clinical pictures, especially in the early stages. Imaging findings in inflammatory and degenerative joint diseases often are nonspecific, especially in the early stages. Imaging findings should be interpreted in light of the clinical context-clinical and paraclinical findings. Good referrals with short clinical history, main clinical findings, disease-involved joint(s), pain distribution, and relevant blood tests increase the likelihood of a correct diagnosis.

Originalsprog Engelsk
Tidsskrift Radiologic Clinics of North America
Vol/bind 57
Udgave nummer 5
Sider (fra-til) 1001-1034
Antal sider 34
ISSN 0033-8389
DOI
Status Udgivet - sep. 2019

Bibliografisk note

Copyright © 2019 Elsevier Inc. All rights reserved.

Impact of TNF inhibitor therapy on joint replacement rates in rheumatoid arthritis: a matched cohort analysis of BSRBR-RA UK registry data

Hawley, S., Ali, M. S., Cordtz, R., Dreyer, L., Edwards, C. J., Arden, N. K., Cooper, C., Judge, A., Hyrich, K. & Prieto-Alhambra, D., 1 jul. 2019, I : Rheumatology (Oxford, England). 58, 7, s. 1168-1175 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: Previous ecological data suggest a decline in the need for joint replacements in RA patients following the introduction of TNF inhibitor (TNFi) therapy, although patient-level data are lacking. Our primary aim was to estimate the association between TNFi use and subsequent incidence of total hip replacement (THR) and total knee replacement.

METHODS: A propensity score matched cohort was analysed using the British Society for Rheumatology Biologics Registry (2001-2016) for RA data. Propensity score estimates were used to match TNFi users to similar conventional synthetic DMARD users (with replacement) using a 1:1 ratio. Weighted multivariable Cox regression was used to estimate the impact of TNFi on study outcomes. Effect modification by baseline age and disease severity were investigated. Joint replacement at other sites was also analysed. An instrumental variable sensitivity analysis was also performed.

RESULTS: The matched analysis contained a total of 19 116 patient records. Overall, there was no significant association between TNFi use vs conventional synthetic DMARD on rates of THR (hazard ratios = 0.86 [95% CI: 0.60, 1.22]) although there was significant effect modification by age (P < 0.001). TNFi was associated with a reduction in THR among those >60 years old (hazard ratio = 0.60 [CI: 0.41, 0.87]) but not in younger patients. No significant associations were found for total knee replacement or other joint replacement.

CONCLUSION: Overall, no association was found between the use of TNFi and subsequent incidence of joint replacement. However, TNFi was associated with a 40% relative reduction in THR rates among older patients.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 58
Udgave nummer 7
Sider (fra-til) 1168-1175
Antal sider 8
ISSN 1462-0324
DOI
Status Udgivet - 1 jul. 2019

Bibliografisk note

© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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