Published in 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

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
Sider (fra-til) e024065
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

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.

Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials

Andersen, K. M., Cheah, J. T. L., March, L., Bartlett, S. J., Beaton, D., Bingham, C. O., Brooks, P. M., Christensen, R., Conaghan, P. G., D'Agostino, M-A., de Wit, M., Dueck, A. C., Goodman, S. M., Grosskleg, S., Hill, C. L., Howell, M., Mackie, S. L., Richards, B., Shea, B., Singh, J. A., Strand, V., Tugwell, P., Wells, G. A. & Simon, L. S., aug. 2019, I : Journal of Rheumatology. 46, 8, s. 1053-1058 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Outcome Measures in Rheumatology (OMERACT) convened a premeeting in 2018 to bring together patients, regulators, researchers, clinicians, and consumers to build upon previous OMERACT drug safety work, with patients fully engaged throughout all phases.

METHODS: Day 1 included a brief introduction to the history of OMERACT and methodology, and an overview of current efforts within and outside OMERACT to identify patient-reported medication safety concerns. On Day 2, two working groups presented results; after each, breakout groups were assembled to discuss findings.

RESULTS: Five themes pertaining to drug safety measurement emerged.

CONCLUSION: Current approaches have failed to include data from the patient's perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 46
Udgave nummer 8
Sider (fra-til) 1053-1058
Antal sider 6
ISSN 0315-162X
DOI
Status Udgivet - aug. 2019

Inflammation and Hypervascularization in a Large Animal Model of Knee Osteoarthritis: Imaging with Pathohistologic Correlation

Korchi, A. M., Cengarle-Samak, A., Okuno, Y., Martel-Pelletier, J., Pelletier, J. P., Boesen, M., Doyon, J., Bodson-Clermont, P., Lussier, B., Héon, H., Sapoval, M., Bureau, N. J. & Soulez, G., jul. 2019, I : Journal of vascular and interventional radiology : JVIR. 30, 7, s. 1116-1127 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: To evaluate if synovial inflammation and hypervascularization are present in a dog model of knee osteoarthritis and can be detected on conventional magnetic resonance imaging (MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), contrast-enhanced magnetic resonance imaging (CE-MRI), and quantitative digital subtraction angiography (Q-DSA) imaging.

MATERIALS AND METHODS: Six dogs underwent MRI and angiography of both knees before and 12 weeks after right knee anterior cruciate ligament injury. Synovial vascularity was evaluated on CE-MRI, DCE-MRI, and Q-DSA by 2 independent observers. Synovial inflammation and vascularity were histologically scored independently. Cartilage lesions and osteophytes were analyzed macroscopically, and cartilage volumetry was analyzed by MRI. Vascularity and osteoarthritis markers on imaging were compared before and after osteoarthritis generation, and between the osteoarthritis model and the control knee, using linear mixed models accounting for within-dog correlation.

RESULTS: In all knees, baseline imaging showed no abnormalities. Control knees did not develop significant osteoarthritis changes, synovial inflammation, or hypervascularization. In osteoarthritis knees, mean synovial enhancement score on CE-MR imaging increased by 13.1 ± 0.59 (P < .0001); mean synovial inflammation variable increased from 47.33 ± 18.61 to 407.97 ± 18.61 on DCE-MR imaging (P < .0001); and area under the curve on Q-DSA increased by 1058.58 ± 199.08 (P = .0043). Synovial inflammation, hypervascularization, and osteophyte formations were present in all osteoarthritis knees. Histology scores showed strong correlation with CE-MR imaging findings (Spearman correlation coefficient [SCC] = 0.742; P = .0002) and Q-DSA findings (SCC = 0.763; P < .0001) and weak correlation with DCE-MR imaging (SCC = -0.345; P = .329). Moderate correlation was found between CE-MR imaging and DSA findings (SCC = 0.536; P = .0004).

CONCLUSIONS: In this early-stage knee osteoarthritis dog model, synovial inflammation and hypervascularization were found on imaging and confirmed by histology.

Originalsprog Engelsk
Tidsskrift Journal of vascular and interventional radiology : JVIR
Vol/bind 30
Udgave nummer 7
Sider (fra-til) 1116-1127
Antal sider 12
ISSN 1051-0443
DOI
Status Udgivet - jul. 2019

Bibliografisk note

Copyright © 2018 SIR. Published by Elsevier Inc. All rights reserved.

Inter-rater agreement and reliability of outcome measurement instruments and staging systems used in hidradenitis suppurativa

Thorlacius, L., Garg, A., Riis, P. T., Nielsen, S. M., Bettoli, V., Ingram, J. R., Del Marmol, V., Matusiak, L., Pascual, J. C., Revuz, J., Sartorius, K., Tzellos, T., van der Zee, H. H., Zouboulis, C. C., Saunte, D. M., Gottlieb, A. B., Christensen, R. & Jemec, G. B. E., sep. 2019, I : British Journal of Dermatology. 181, 3, s. 483-491 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Monitoring disease activity over time is a prerequisite for clinical practice and research. Valid and reliable outcome measurement instruments (OMIs) and staging systems provide researchers and clinicians with benchmark tools to assess the primary and secondary outcomes of interventional trials and to guide treatment selection properly.

OBJECTIVES: To investigate inter-rater reliability and agreement in instruments currently used in hidradenitis suppurativa (HS), with dermatologists experienced in HS as the rater population of interest.

METHODS: In a prospective completely balanced design, 24 patients with HS underwent a physical examination by 12 raters (288 assessments) using nine instruments. The results were analysed using generalized linear mixed models.

RESULTS: For the staging systems, the study found good inter-rater reliability for Hurley staging in the axillae and gluteal region, moderate inter-rater reliability for Hurley staging in the groin and for Physician's Global Assessment, and fair inter-rater reliability for refined Hurley staging and the International HS Severity Scoring System. For all the tested OMIs, the observed intervals for limits of agreement were very wide relative to the ranges of the scales.

CONCLUSIONS: The very wide intervals for limits of agreement imply that substantial changes are needed in clinical research in order to rule out measurement error. The results illustrate a difficulty, even for experienced HS experts, to agree on the type and number of lesions when evaluating disease severity. The apparent caveats call for global efforts, such as the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) to reach consensus on how best to measure physical signs of HS reliably in randomized trials. What's already known about this topic? Without valid and reliable instruments to measure outcomes, researchers and clinicians lack the necessary benchmarks to assess primary and secondary end points of interventional trials properly. Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. Several outcome measure instruments exist for HS, but their validation is generally incomplete or of relatively low methodological quality. What does this study add? Using a prospective completely balanced design this study examined inter-rater reliability with HS-experienced dermatologists as the rater population of interest. The study did not find very good reliability for any included instrument or lesion counts. This study illustrates the difficulty in finding agreement on the type and number of HS lesions, even among experts. The results question whether physical signs are best measured by a traditional physician lesion count instrument. What are the clinical implications of this work? For staging, Hurley staging and physician global visual analogue scale proved to be acceptable instruments in terms of inter-rater reliability. For the instruments designed to measure changes in health status, our study illustrates how difficult it is, even for experts, to measure the physical signs of HS using a simple rater counting. Consequently, other assessment methods of physicals signs, such as ultrasound evaluation, require consideration.

Originalsprog Engelsk
Tidsskrift British Journal of Dermatology
Vol/bind 181
Udgave nummer 3
Sider (fra-til) 483-491
Antal sider 9
ISSN 0007-0963
DOI
Status Udgivet - sep. 2019

Bibliografisk note

© 2019 British Association of Dermatologists.

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