Published in 2021

Concurrent Validity Between Electronically Administered Physical Activity Questionnaires and Objectively Measured Physical Activity in Danish Community-Dwelling Older Adults

Larsen, R. T., Korfitsen, C. B., Juhl, C. B., Boje Andersen, H., Langberg, H. & Christensen, J., aug. 2021, I: Journal of Aging and Physical Activity. 29, 4, s. 595-603 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

AIM: To investigate the concurrent validity of the International Physical Activity Questionnaire-short form (IPAQ-SF) and the Nordic Physical Activity Questionnaire-short (NPAQ-short) when compared with objectively measured daily steps among older adults.

METHODS: Spearman's ρ between IPAQ-SF and NPAQ-short and objectively measured steps using Garmin Vivofit 3 physical activity monitors.

RESULTS: A total of 54 participants were included. The IPAQ-SF subscales' moderate physical activity (PA), moderate to vigorous PA (MVPA), and sedentary time showed little or no correlation with daily steps. The NPAQ-short subscales' vigorous PA, moderate PA, and MVPA showed little or no correlation. The IPAQ-SF subscales' vigorous PA and walking showed fair correlation. Only the IPAQ-SF metabolic equivalent of task minutes showed moderate to good correlation with daily steps. The IPAQ-SF categories and NPAQ-short categorization of World Health Organization compliance were significantly different, but the magnitudes were small and distributions indicated problems with the categorization.

CONCLUSION: The concurrent validity is low, as the scores did not reflect objectively measured daily steps.

Originalsprog Engelsk
Tidsskrift Journal of Aging and Physical Activity
Vol/bind 29
Udgave nummer 4
Sider (fra-til) 595-603
Antal sider 9
ISSN 1063-8652
DOI
Status Udgivet - aug. 2021

Consumption of sugar-sweetened beverages and metabolic markers in children – a narrative review of the evidence

Olsen, N. J. & Lilienthal Heitmann, B., sep. 2021, I: Nutrition Bulletin. 46, 3, s. 264-278 15 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

A healthy hydration habit is an important aspect of a healthy diet, but recommendations on beverage choices are still less detailed than food-based recommendations. It is our working hypothesis that frequent consumption of sugar-sweetened beverages (SSBs) may cause insulin resistance by inducing rapid increases in insulin concentration. Insulin resistance is central to the risk of developing type 2 diabetes and may also be linked to development of obesity. This narrative review aims to review the literature on SSB consumption in relation to adverse markers of glucose metabolism in children. Literature searches were conducted in Medline and Embase via Ovid® on June 21st and June 22nd, 2020. From 8892 titles, abstracts were screened from 76 publications. This screening resulted in the inclusion of 13 publications, while reference screening of the 13 publications resulted in inclusion of an additional six publications. A total of 11 cross-sectional studies, two prospective studies, five experimental studies and one randomised controlled trial were reviewed. The majority of the reviewed studies reported significant, positive associations between SSB consumption and a broad range of adverse markers of glucose metabolism. Results suggested that the adverse effects of SSB consumption on metabolic health may not be limited to individuals with overweight. The results suggest that more frequent consumption of SSBs may be associated with adverse markers of glucose metabolic health among children. However, the evidence is limited by a paucity of prospective studies and randomised controlled trials, as well as by profound heterogeneity in definitions of exposures and outcomes.

Originalsprog Engelsk
Tidsskrift Nutrition Bulletin
Vol/bind 46
Udgave nummer 3
Sider (fra-til) 264-278
Antal sider 15
ISSN 1471-9827
DOI
Status Udgivet - sep. 2021

Bibliografisk note

Funding Information:
NJO and BLH conceptualised the study. NJO conducted the literature search and reviewed the literature. NJO wrote the manuscript, with contributions from BLH. The Parker Institute, Bispebjerg and Frederiksberg Hospital, is supported by a core grant from the Oak Foundation (OCAY‐13‐309).

Publisher Copyright:
© 2021 British Nutrition Foundation

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial

Karlsen, R. V., Bidstrup, P. E., Giraldi, A., Hvarness, H., Bagi, P., Lauridsen, S. V., Albieri, V., Frederiksen, M., Krause, E., Due, U. & Johansen, C., 3 jun. 2021, I: Sexual Medicine. 9, 3, s. 100350

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function.

AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP.

METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention.

MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners.

RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months.

CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

Originalsprog Engelsk
Tidsskrift Sexual Medicine
Vol/bind 9
Udgave nummer 3
Sider (fra-til) 100350
ISSN 2050-1161
DOI
Status Udgivet - 3 jun. 2021

OBJECTIVE: To summarize the literature on trans-arterial embolization in inflammatory musculoskeletal conditions, focusing on efficacy and safety.

MATERIALS AND METHODS: PRISMA guidelines were followed. A systematic literature search revealed 19 studies, with a total of 394 participants, eligible for inclusion.

RESULTS: The included studies consisted of case reports/series and non-randomized interventional studies, with knee osteoarthritis and adhesive capsulitis of the shoulder as the most frequent conditions. In all studies except one, pain was reduced up to four years after treatment. All adverse events were transient. Due to high heterogeneity, meta-analysis was not possible.

CONCLUSION: The included early studies showed encouraging results regarding efficacy and safety. However, randomized, placebo-controlled trials are warranted.

Originalsprog Engelsk
Tidsskrift Cardiovascular and Interventional Radiology
ISSN 0174-1551
DOI
Status E-pub ahead of print - 2 sep. 2021

Danish translation, adaptation and initial validation of the clinical assessment of modes questionnaires

Enemark Larsen, A., Nielsen, K. T., Taylor, R., Pilegaard, M. S. & Wæhrens, E. E., 23 jul. 2021, (E-pub ahead of print) I: Scandinavian Journal of Occupational Therapy.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: The Clinical Assessment of Modes questionnaires (CAMQs) determine clients' preferential modes for therapy (CAM-C1), clients’ perception of modes used by the occupational therapist (OTs) during therapy (CAM-C2), or modes the OTs believed to have used (CAM-T). Access to valid CAMQs for Danish OTs and clients required a rigorous translation and cultural adaptation process. Objectives: To translate and culturally adapt the CAMQs into Danish, examining face validity in a Danish context. Material and methods: A 10-step guideline for the process of translating and culturally adapting questionnaires was followed. Steps 1–6 included translation into Danish, steps 7–8 involved cognitive debriefing interviews and validation based on the Content Validity Index (CVI) analyzed using Kappa statistics. Steps 9–10 finalized the process. Results: CAMQs were translated into Danish. Based on cognitive debriefing interviews and CVIs involving 15 clients and 7 OTs, modifications regarding titles, layouts, instructions, wording and response categories were performed in all Danish CAMQs. The Item CVI and the modified kappa revealed that most participants had a high level of agreement on the cultural relevance. Conclusions and significance: Translated versions of the CAMQs have been culturally adapted into Danish. The current Danish versions seem culturally relevant and useable in Danish occupational therapy.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
ISSN 1103-8128
DOI
Status E-pub ahead of print - 23 jul. 2021

Bibliografisk note

Publisher Copyright:
© 2021 Scandinavian Journal of Occupational Therapy Foundation.

Danish translation, cultural adaptation and initial validation of the Self-Assessment of modes questionnaire (D-SAMQ)

Sampedro Pilegaard, M., Sithamparanathan, T., Nielsen, K. T., Taylor, R. & Waehrens, E. E., maj 2021, I: Scandinavian Journal of Occupational Therapy. 28, 4, s. 285-293 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The Self-Assessment of Modes Questionnaire (SAMQ) was developed for occupational therapists (OTs) to identify their therapeutic style when interacting with clients. To provide Danish Occupational Therapists (OTs) with access to the SAMQ, a rigorous translation, cultural adaptation and validation are required.

AIM: To describe the process of translating and culturally adapting the SAMQ into Danish (D-SAMQ) and examining initial validation of the SAMQ in terms of relevance and comprehensiveness in a Danish context.

MATERIAL AND METHODS: A 10-step process for translation and cultural adaptation was followed: (1) Preparation, (2) Forward translation, (3) Reconciliation, (4) Back translation, (5) Back-translation review, (6) Harmonization, (7) Cognitive debriefing, (8) Review of cognitive debriefing results and finalization, (9) Proofreading and (10) Final report. The cognitive debriefing also involved validation.

RESULTS: Seven OTs and one OT student were included in the cognitive debriefing. Adaptations were made in eight of twenty cases, and modifications regarding the choice of words, sentence structure, and rephrasing were performed. The participants suggested more contextual details in the case descriptions.

CONCLUSION: The SAMQ was translated into Danish (D-SAMQ) and adapted and validated by Danish OTs. The D-SAMQ may enable OTs to identify their therapeutic style, and thereby improve the client-therapist relationship.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
Vol/bind 28
Udgave nummer 4
Sider (fra-til) 285-293
Antal sider 9
ISSN 1103-8128
DOI
Status Udgivet - maj 2021

Determining a healthy reference range and factors potentially influencing PRO-C3 - A biomarker of liver fibrosis

Erhardtsen, E., Rasmussen, D. G. K., Frederiksen, P., Leeming, D. J., Shevell, D., Gluud, L. L., Karsdal, M. A., Aithal, G. P. & Schattenberg, J. M., aug. 2021, I: JHEP reports : innovation in hepatology. 3, 4, 100317.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background & Aims: Progressive fibrosis has been identified as the major predictor of mortality in patients with non-alcoholic fatty liver disease (NAFLD). Several biomarkers are currently being evaluated for their ability to substitute the liver biopsy as the reference standard. Recent clinical studies in NAFLD/NASH patients support the utility of PRO-C3, a marker of type III collagen formation, as a marker for the degree of fibrosis, disease activity, and effect of treatment. Here we establish the healthy reference range, optimal sample handling conditions for both short- and long-term serum storage, and robustness for the PRO-C3 assay.

Methods: PRO-C3 was measured in 269 healthy volunteers and in 222 NAFLD patients. Robustness of the PRO-C3 assay was measured according to Clinical and Laboratory Standards Institute standards and included validation of interference, precision, and reagent stability, whilst sample stability was defined for storage at different temperatures and for 3 freeze-thaw cycles. Fibrosis scoring was based on histological assessments and used as a reference for the diagnostic ability of PRO-C3 to discriminate between patients with different levels of fibrosis.

Results: Robustness of the PRO-C3 analysis validated by interference, precision, and reagent stability was found to be within the predefined acceptance criteria. The healthy reference range was determined to be 6.1-14.7 ng/ml. Levels of PRO-C3 were not affected by sex, age, BMI, or ethnicity. Levels of PRO-C3 were able to identify patients with clinically significant fibrosis and advanced fibrosis (AUC = 0.83 (95% CI [0.77-0.88], p <0.0001), and AUC = 0.79 (95% CI [0.73-0.85], p <0.0001), respectively).

Conclusions: The assay proved to be robust and sample stability was found to comply with hospital sample handling requirements. PRO-C3 measured in samples from patients with NAFLD/NASH was diagnostic for significant and advanced liver fibrosis.

Lay summary: We showed that PRO-C3 levels were stable under conditions conforming with hospital sample-handling requirements. We determined a healthy reference range and showed that PRO-C3 levels were not associated with sex, age, BMI, or ethnicity. Finally, we provide further evidence of an association of PRO-C3 with increasing liver fibrosis.

Originalsprog Engelsk
Artikelnummer 100317
Tidsskrift JHEP reports : innovation in hepatology
Vol/bind 3
Udgave nummer 4
ISSN 2589-5559
DOI
Status Udgivet - aug. 2021

Developing a composite outcome tool to measure response to treatment in ANCA-associated vasculitis: A mixed methods study from OMERACT 2020

Quinn, K. A., Monti, S., Christensen, R., Jayne, D., Langford, C. A., Lanier, G. E., Mahr, A., Pagnoux, C., Shea, B., Tugwell, P., Viðarsdóttir, M. B., Tomasson, G. & Merkel, P. A., okt. 2021, I: Seminars in Arthritis and Rheumatism. 51, 5, s. 1134-1138 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group aims to develop composite response criteria for ANCA-Associated Vasculitis (AAV).

METHODS: The project follows the OMERACT approach for composite measures: (i) choose relevant domains; (ii) define high-quality instruments; (iii) decide on a scoring system approach; (iv) put through the OMERACT Filter 2.1 for validation.

RESULTS: A systematic literature review of outcome measures used in clinical trials in AAV and an international Delphi exercise among patients with AAV and clinician-investigators with expertise in AAV have been completed to inform the candidate domains/instruments for the composite response criteria, which are the first two steps in the OMERACT approach for developing composite measures. Results of the systematic literature review and Delphi were presented at the OMERACT 2020 virtual workshop, and feedback was received on the next steps of the project, including the development of a scoring system approach.

CONCLUSION: The ultimate goal of this project is to develop validated composite response criteria for use in clinical trials of AAV.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 5
Sider (fra-til) 1134-1138
Antal sider 5
ISSN 0049-0172
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Published by Elsevier Inc.

Development and cross-cultural validation of the Goal Content for Weight Maintenance Scale (GCWMS)

Encantado, J., Marques, M. M., Palmeira, A. L., Sebire, S. J., Teixeira, P. J., Stubbs, R. J., Heitmann, B. L. & Gouveia, M. J., dec. 2021, I: Eating and Weight Disorders. 26, 8, s. 2737-2748 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: Long-term weight management requires sustained engagement with energy-balance-related behaviours. According to self-determination theory, behaviour goals can support or undermine motivation depending on the quality of their content (i.e., extrinsic and intrinsic motivation). This study aimed to develop and validate the goal content for weight loss maintenance scale (GCWMS).

METHODS: The GCWMS was administered to 1511 participants who had achieved clinically significant weight losses and were taking part in a large weight loss maintenance study: the NoHoW Trial (ISRCTN88405328). The scale derived from two well-established questionnaires regarding exercise goals. Construct validity was examined for 4 theory-driven domains: Health Management, Challenge, Image, and Social Recognition. Split-sample confirmatory factor analysis was conducted to test the factorial validity and multi-group measurement invariance (configural, metric, scalar, and residual invariance). The reliability estimates were also assessed, and discriminant validity was evaluated using 2 conceptually related questionnaires.

RESULTS: The first analysis showed a poor fit of the original factorial structure. Subsequent investigation with a new specified model indicated close fit to the data after removal of 3 items χ2(58) = 599.982; p < .001; χ2/df = 10.345; CFI = 0.940; GFI = 0.941; SRMR = 0.063; RMSEA = 0.079 (LL = 0.073; UL = .084). Good internal consistency was achieved in all subscales (α > .775), convergent and divergent validity were verified through associations with other theoretical related constructs. Findings from multi-group invariance test demonstrated that the specified model of GCWMS achieved full measurement invariance for gender but did not support residual invariance across countries.

CONCLUSION: Findings support the hypothesised four-dimension structure of the GCWMS, confirming reliability and multi-group invariance in factor structure. Analysis also supports valid group means comparisons on latent factors at gender and at cross-cultural level. Ways to improve the quality of the scale are discussed.

LEVEL OF EVIDENCE: Level V, cross-sectional descriptive.

Originalsprog Engelsk
Tidsskrift Eating and Weight Disorders
Vol/bind 26
Udgave nummer 8
Sider (fra-til) 2737-2748
Antal sider 12
ISSN 1124-4909
DOI
Status Udgivet - dec. 2021

Bibliografisk note

© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.

OBJECTIVE: In axial spondyloarthritis (axSpA), sacroiliac joint (SIJ) erosion is often followed by fat metaplasia in an erosion cavity (backfill), and subsequently ankylosis. We aimed to combine the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score for erosion, backfill, and ankylosis into 3 versions of a novel preliminary axSpA magnetic resonance imaging (MRI) SIJ Composite Structural Damage Score (CSDS) and to test these.

METHODS: Thirty-three patients with axSpA, followed for 5 years after initiation of tumor necrosis factor inhibitor, had MRIs of the SIJs at baseline, and yearly thereafter. Three versions of CSDS were calculated based on different weightings of erosion, backfill, and ankylosis: (1) equal weighting: CSDSequal = (erosion × 0.5) + backfill + ankylosis; (2) advanced stages weighting more: CSDSstepwise = (erosion × 1) + (backfill × 4) + (ankylosis × 6); and (3) advanced stages overruling earlier stages ("hierarchical") with "<" meaning "overruled by": CSDShierarchical = (erosion × 1) < (backfill × 4) < (ankylosis × 6).

RESULTS: At baseline, all CSDS correlated positively with SPARCC fat and ankylosis scores and modified New York radiography grading, and negatively with the Bath Ankylosing Spondylitis Disease Index and SPARCC SIJ inflammation scores. CSDSstepwise and CSDShierarchical (not CSDSequal) correlated positively with symptom duration and the Bath Ankylosing Spondylitis Metrology Index, and closer with SPARCC ankylosis score and modified New York radiography grading than CSDSequal. The adjusted annual progression rate for CSDSstepwise and CSDShierarchical (not CSDSequal) was higher the first year compared with fourth year (P = 0.04 and P = 0.01). Standardized response mean (baseline to Week 46) was moderate for CSDShierarchical (0.64) and CSDSstepwise (0.59) and small for CSDSequal (0.25).

CONCLUSION: Particularly CSDSstepwise and CSDShierarchical showed construct validity and responsiveness, encouraging further validation in larger clinical trials. The potential clinical implication is assessment of SIJ damage progression by 1 composite score.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 48
Udgave nummer 10
Sider (fra-til) 1537-1546
Antal sider 10
ISSN 0315-162X
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 by the Journal of Rheumatology.

Development of a patient-centered core domain set for prospective observational longitudinal outcome studies in rheumatoid arthritis: an OMERACT initiative

Bruera, S., Carmona, L., Lopez-Olivo, M. A., Westrich-Robertson, T., March, L., Negron, J. B., Christensen, R., Strand, V., Ingegnoli, F., Goel, N., Shea, B., Tugwell, P., Leong, A., Bingham, C. O., Hill, C. L. & Suarez-Almazor, M. E., okt. 2021, I: Seminars in Arthritis and Rheumatism. 51, 5, s. 1113-1116 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis.

METHODS: Our working group held a virtual meeting in November 2020 to review data from a literature review and patient qualitative interviews, and to discuss strategies to move forward on domain identification and selection using the OMERACT 2.1 domain selection process.

RESULTS: Important candidate domains and subdomains were identified including in the areas of life impact. Consensus was reached on moving forward with a Delphi process.

CONCLUSIONS: The meeting provided future directions to identify and select a core set of domains for use in LOS.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 5
Sider (fra-til) 1113-1116
Antal sider 4
ISSN 0049-0172
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

Diagnostic accuracy of vascular ultrasound in patients with suspected giant cell arteritis (EUREKA): a prospective, multicentre, non-interventional, cohort study

Chrysidis, S., Døhn, U. M., Terslev, L., Fredberg, U., Lorenzen, T., Christensen, R., Larsen, K. & Diamantopoulos, A. P., dec. 2021, I: The Lancet Rheumatology. 3, 12, s. e865-e873

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Temporal artery biopsy is considered the diagnostic gold standard for giant cell arteritis, despite approximately 39% of patients who are negative for the condition by biopsy subsequently being given a clinical diagnosis of giant cell arteritis. We aimed to assess the diagnostic accuracy of ultrasound examination in patients with suspected giant cell arteritis. Methods: In this prospective, multicentre, non-interventional, cohort study (evaluation of ultrasound's role in patients suspected of having extracranial and cranial giant cell arteritis; EUREKA), we consecutively recruited patients aged 50 years or older, with clinically suspected giant cell arteritis from three Danish hospitals (South West Jutland Hospital in Esbjerg, Silkeborg Regional Hospital, and Rigshospitalet, Glostrup). Participants had a bilateral ultrasound of the temporal, facial, common carotid, and axillary arteries. Ultrasounds were done by ultrasonographers who were systematically trained in vascular ultrasound using appropriate equipment and settings. Participants then had a temporal artery biopsy within 7 days of initiation of corticosteroid treatment. A blinded ultrasound expert assessed all ultrasound images. Ultrasound vasculitis was defined in cranial arteries as a homogeneous, hypoechoic, intimamedia complex thickness and a positive compression sign and as a homogeneous intimamedia complex of 1 mm in thickness or wider in the axillary arteries and of 1·5 mm thickness or wider in the common carotid artery. Participants were followed up at 6 months. During this 6 month period, clinicians were able to collect data from all clinical examinations to enable a full clinical diagnosis at 6 months. Clinical diagnosis was based on the expert opinion of the treating rheumatologist. The diagnostic criterion standard was diagnosis confirmed after 6 months of follow-up. We used logistic regression analyses to calculate the odds ratio and 95% CI of ultrasound as a predictor for giant cell arteritis. Findings: Between April 1, 2014, and July 31, 2017, 118 patients were screened for inclusion, of whom 106 had both ultrasound examinations and an eligible temporal artery biopsy and were included in the intention-to-diagnose population. The mean age was 72·7 years (SD 7·9), 63 (59%) participants were women, and 43 (41%) were men. Temporal artery biopsy was positive in 46 (43%) of 106 patients, and 62 (58%) of 106 patients had a clinically confirmed diagnosis of giant cell arteritis at 6 months (temporal artery biopsy sensitivity 74% [95% CI 62–84], specificity 100% [95% CI 92–100]). Cranial artery ultrasound was positive in all patients who had a positive temporal artery biopsy, and seven (58%) of 12 patients who were positive by ultrasound and negative by temporal artery biopsy were confirmed to have large-vessel giant cell arteritis via other imaging methods. The sensitivity of ultrasound diagnosis of giant cell arteritis was 94% (84–98) and specificity was 84% (70–93). Logistic regression analysis confirmed that ultrasound was the strongest baseline predictor for a clinically confirmed diagnosis of giant cell arteritis at 6 months (crude odds ratio 76·6 [95% CI 21·0–280·0]; adjusted for sex and age 141·0 [27·0–743·0]). Interpretation: Vascular ultrasound might effectively replace temporal artery biopsy as a first-line diagnostic method in patients suspected of having giant cell arteritis when done by systematically trained ultrasonographers using appropriate equipment and settings. Funding: The Institute for Regional Research at Hospital of Southwest Jutland, Esbjerg, Denmark.

Originalsprog Engelsk
Tidsskrift The Lancet Rheumatology
Vol/bind 3
Udgave nummer 12
Sider (fra-til) e865-e873
ISSN 2665-9913
DOI
Status Udgivet - dec. 2021

Bibliografisk note

Funding Information:
We thank Jakob Ingdahl Matthisson, Per Søndergaard, and the ophthalmological department at Glostrup Hospital for their support on taking the temporal artery biopsies. Furthermore, we thank the pathological departments in Esbjerg Hospital, Glostrup Hospital, and Viborg Hospital for their contribution to biopsy specimen descriptions. The Institute for Regional Research at Hospital of Southwest Jutland, Esbjerg, Denmark, granted research grants for the study as a part of a PhD project. The Parker institute at Bispebjerg, and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

Funding Information:
We thank Jakob Ingdahl Matthisson, Per S?ndergaard, and the ophthalmological department at Glostrup Hospital for their support on taking the temporal artery biopsies. Furthermore, we thank the pathological departments in Esbjerg Hospital, Glostrup Hospital, and Viborg Hospital for their contribution to biopsy specimen descriptions. The Institute for Regional Research at Hospital of Southwest Jutland, Esbjerg, Denmark, granted research grants for the study as a part of a PhD project. The Parker institute at Bispebjerg, and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

Publisher Copyright:
© 2021 Elsevier Ltd

Dietary trans-fatty acid intake in relation to cancer risk: a systematic review and meta-analysis

Michels, N., Specht, I. O., Heitmann, B. L., Chajès, V. & Huybrechts, I., 4 jun. 2021, I: Nutrition Reviews. 79, 7, s. 758-776 19 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

CONTEXT: Apart from ruminant fat, trans-fatty acids are produced during the partial hydrogenation of vegetable oils, (eg, in the production of ultraprocessed foods). Harmful cardiovascular effects of trans-fatty acids are already proven, but the link with cancer risk has not yet been summarized.

OBJECTIVE: A systematic review (following PRISMA guidelines) - including observational studies on the association of trans-fatty acid intake with any cancer risk - was conducted, with no limitations on population types.

DATA SOURCES: The electronic databases PubMed and Embase were searched to identify relevant studies.

DATA EXTRACTION: This systematic review included 46 articles. Quality was assessed via the Newcastle-Ottawa scale. Meta-analyses were conducted if at least 4 articles exploring the same transfat-cancer pairings were found.

DATA ANALYSIS: Nineteen cancer types have been researched in cohort and case-control studies on trans-fatty acids, with breast cancer (n = 17), prostate cancer (n = 11), and colorectal cancer (n = 9) as the most researched. The meta-analyses on total trans-fat showed a significant positive association for prostate cancer (odds ratio [OR] 1.49; 95%CI, 1.13-1.95) and colorectal cancer (OR 1.26; 95%CI, 1.08-1.46) but not for breast cancer (OR 1.12; 95%CI, 0.99-1.26), ovarian cancer (OR 1.10; 95%CI, 0.94-1.28), or non-Hodgkin lymphoma (OR 1.32; 95%CI, 0.99-1.76). Results were dependent on the fatty acid subtype, with even cancer-protective associations for some partially hydrogenated vegetable oils. Enhancing moderators in the positive transfat-cancer relation were gender (direction was cancer-site specific), European ancestry, menopause, older age, and overweight.

CONCLUSION: Despite heterogeneity, higher risk of prostate and colorectal cancer by high consumption of trans-fatty acids was found. Future studies need methodological improvements (eg, using long-term follow-up cancer data and intake biomarkers). Owing to the lack of studies testing trans-fatty acid subtypes in standardized ways, it is not clear which subtypes (eg, ruminant sources) are more carcinogenic.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42018105899.

Originalsprog Engelsk
Tidsskrift Nutrition Reviews
Vol/bind 79
Udgave nummer 7
Sider (fra-til) 758-776
Antal sider 19
ISSN 0029-6643
DOI
Status Udgivet - 4 jun. 2021

OBJECTIVE: To assess the ability of ultrasound to predict successful tapering and successful discontinuation of biological DMARDs (bDMARDs) at the 2-year follow-up in RA patients in sustained remission.

METHODS: Patients in sustained remission (DAS28-CRP ≤ 2.6) and with no radiographic progression the previous year tapered bDMARDs according to a standardized regime. A total of 119 of these patients were included in this ultrasound substudy. At baseline, clinical assessment, MRI, X-ray and ultrasound of 24 joints were performed. Ultrasound-detected synovitis was defined and scored 0-3 using the OMERACT scoring system at the joint level for both grey-scale and Doppler activity. Sum scores for each ultrasound modality were calculated for 24 joints at the patient level. The final state of treatment was assessed after 2 years. The predictive value of ultrasound measures for successful tapering and discontinuation at the 2-year follow-up was assessed via logistic regression analyses.

RESULTS: Negative IgM-RF [odds ratio (OR) = 0.29, 95% CI: 0.10-0.85; P = 0.024] and lower Doppler sum score of 24 joints (OR = 0.44, 95% CI: 0.15, 0.87; P = 0.014) were independent predictors for successful discontinuation of bDMARDs at the 2-year follow-up. The predictive value of the Doppler sum score was independent of MRI findings. Previous numbers of bDMARDs were predictive of successful tapering (OR = 0.58, 95% CI: 0.35, 0.91; P = 0.018), whereas ultrasound was not. Clinical parameters were not predictive of successful tapering/discontinuation.

CONCLUSION: Doppler sum score was an independent predictor for successful discontinuation of bDMARDs at the 2-year follow-up-the odds for achieving successful discontinuation decreased by 56% per one-unit increase in Doppler sum score. Ultrasound could not predict successful tapering.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 12
Sider (fra-til) 5549-5559
Antal sider 11
ISSN 1462-0324
DOI
Status Udgivet - 1 dec. 2021

Bibliografisk note

© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

OBJECTIVES: The aim of this study was to determine the diagnostic performance of dual-energy computed tomography (DECT) to detect and distinguish crystal deposits in a phantom. The primary objective was to determine the cutoff DECT ratio and the cross-sectional area (CSA) of a crystal deposit necessary to differentiate monosodium urate (MSU), calcium pyrophosphate (CPP), and calcium hydroxyapatite (HA) using DECT. Our secondary objective was to determine the concentration for limit of detection for MSU, CPP, and HA crystal deposits. Exploratory objectives included the comparison between 2 generations of DECT scanners from the same manufacturer as well as different scanner settings.

MATERIALS AND METHODS: We used a cylindrical soft tissue phantom with synthetic MSU, CPP, and HA crystals suspended in resin. Crystal suspension concentration increased with similar attenuation between MSU, CPP, and HA in conventional CT. The phantom was scanned on 2 dual-source DECT scanners, at 2 dose levels and all available tube voltage combinations. Both scanners had a tin (Sn) filter at the high-energy spectra. Dual-energy CT ratios were calculated for a given tube voltage combination by dividing linear regression lines of CT numbers against concentration. Dual-energy CT ratios were compared using an analysis of covariance. Receiver operating characteristic curves and corresponding areas under the curve (AUCs) were calculated for individual crystal suspension comparisons (HA vs CPP, MSU vs CPP, and MSU vs HA).

RESULTS: At standard clinical scan settings with 8 mGy and 80/Sn150 kV, the DECT ratios were as follows: CPP, 2.02 (95% confidence interval [CI], 1.98-2.07); HA, 2.00 (95% CI, 1.96-2.05); and MSU, 1.09 (95% CI, 1.06-1.11). Ratios varied numerically depending on the scanner and tube voltage combination. Monosodium urate crystal DECT ratios were significantly different from HA and CPP (P < 0.001), whereas DECT ratios for HA and CPP crystals did not differ significantly (P = 0.99). The differentiation of MSU crystals from both calcium crystals (HA and CPP) was excellent with an AUC of 1.00 (95% CI, 1.00-1.00) and an optimal cutoff DECT ratio of 1.43:1.40 depending on the scanner. In addition, differentiation of MSU and calcium-containing crystals (HA and CPP) required a CSA of minimum 4 pixels of crystal at standard clinical scan conditions. In contrast, differentiation between CPP and HA crystals was moderate with AUCs ranging from 0.66 (95% CI, 0.52-0.80) to 0.80 (95% CI, 0.69-0.91) and an optimal cutoff DECT ratio of 2.02:2.06 depending on the scanner. Furthermore, differentiation between CPP and HA crystals required a CSA of minimum 87 pixels of crystal at standard clinical scan conditions, corresponding to a region of interest of 3.7 mm diameter. When scanning at highest possible spectral separation and maximum dose of 50 mGy, the limit of detection for crystals within a region of interest of 50 pixels was 14 mg/cm3 for MSU and 2 mg/cm3 for both CPP and HA.

CONCLUSIONS: This phantom study shows that DECT can be used to detect MSU, CPP, and HA crystal deposits. Differentiation of CPP and HA was not possible in crystals deposits less than 3.7 mm in diameter, but MSU could accurately be differentiated from CPP and HA crystal deposits at standard clinical scan conditions.

Originalsprog Engelsk
Tidsskrift Investigative Radiology
Vol/bind 56
Udgave nummer 7
Sider (fra-til) 417-424
Antal sider 8
ISSN 0020-9996
DOI
Status Udgivet - 1 jul. 2021

STUDY DESIGN: Randomized controlled trial with 1-year follow up.

OBJECTIVE: The aim of this study was to assess whether people with low back pain (LBP) and self-reported physically demanding jobs, benefit from an occupational medicine intervention, in addition to a single hospital consultation and a magnetic resonance imaging, at 1 year of follow-up. Secondly, to examine whether the positive health effects, found in both groups at 6 months, persist at 1-year follow-up.

SUMMARY OF BACKGROUND DATA: The prevalence of LBP is high in the working population, resulting in a substantial social and economic burden. Although there are many guidelines available on the management of LBP, including multidisciplinary biopsychosocial rehabilitation, they provide limited guidance on the occupational medicine aspects.

METHODS: As reported previously, 305 participants with LBP and self-reported physically demanding jobs were enrolled in the randomized controlled study and randomly allocated to clinical care with additional occupational medicine intervention or clinical care alone. Data were collected at baseline, 6 months, and 1 year. Outcomes included in the present 1-year follow-up study are changes in neuropathic pain (painDETECT questionnaire), severity of pain (0-10 numerical rating scale), disability (Roland Morris Disability Questionnaire), fear-avoidance beliefs (FABQ), physical, and mental quality of life (short-form 36).

RESULTS: The study showed no effect of an occupational intervention on neuropathic pain, fear-avoidance beliefs, physical and mental quality of life nor disability measured after 1 year. The positive effects found at 6 months in both groups, remained at 1-year follow-up.

CONCLUSION: The results suggest that a thorough clinical consultation, with focus on explaining the cause of pain and instructions to stay active, can promote long-lasting physical and mental health in individuals with LBP. Therefore, additional occupational interventions could focus on altering occupational obstacles on a structural level.Level of Evidence: 2.

Originalsprog Engelsk
Tidsskrift Spine
Vol/bind 46
Udgave nummer 6
Sider (fra-til) 347-355
Antal sider 9
ISSN 0362-2436
DOI
Status Udgivet - 15 mar. 2021

On 11 March 2020, a lockdown to limit the spread of COVID-19 was implemented in Denmark. The pandemic and the lockdown might have caused stress, depression, and anxiety in new mothers. Individuals with high resilience to stress may have been less affected. This study aimed to investigate if changes in perceived stress, anxiety, depression, and resilience from the second trimester until two months postpartum were different before and during the COVID-19 pandemic in Denmark in spring 2020. Pregnant women enrolled in an ongoing feasibility study completed an online questionnaire measuring perceived stress, depression, anxiety, and resilience in the second trimester and two months postpartum. Changes in scores between women completing the two-month postpartum questionnaire before (n = 26) or during (n = 47) the COVID-19 pandemic were calculated. No statistically significant differences in changes from baseline to follow-up between pre- and during-pandemic groups in Cohen's Perceived Stress Scale (PSS), the Depression, Anxiety, Stress Scale (DASS), or the Connor-Davidson Resilience Scale (CD-RISC) were found. Adjusted differences in group means were as follows: PSS: 0.70 (CI-2.45; 3.85); DASS Stress: 0.76 (CI-3.59; 2.08); DASS Anxiety: 0.47 (CI-0.84; 1.77); DASS Depression: 0.88 (CI-0.95; 2.71); and CD-RISC: 1.19 (CI-3.16; 5.54). In conclusion, we did not find significant differences in the development of stress, depression, anxiety, or resilience before or during the Danish COVID-19 pandemic in spring 2020.

Originalsprog Engelsk
Artikelnummer 11734
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 18
Udgave nummer 22
Sider (fra-til) 1-9
Antal sider 9
ISSN 1661-7827
DOI
Status Udgivet - 9 nov. 2021

Effect Modifiers and Statistical Tests for Interaction in Randomized Trials

Christensen, R., Bours, M. J. L. & Nielsen, S. M., jun. 2021, I: Journal of Clinical Epidemiology. 134, s. 174-177 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Statistical analyses of randomized controlled trials (RCTs) yield a causally valid estimate of the overall treatment effect, which is the contrast between the outcomes in two randomized treatment groups commonly accompanied by a confidence interval. In addition, the trial investigators may want to examine whether the observed treatment effect varies across patient subgroups (also called 'heterogeneity of treatment effects'), i.e. whether the treatment effect is modified by the value of a variable assessed at baseline. The statistical approach for this evaluation of potential effect modifiers is a test for statistical interaction to evaluate whether the treatment effect varies across levels of the effect modifier. In this article, we provide a concise and nontechnical explanation of the use of simple statistical tests for interaction to identify effect modifiers in RCTs. We explain how to calculate the test of interaction by hand, applied to a dataset with simulated data on 1,000 imaginary participants for illustration.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 134
Sider (fra-til) 174-177
Antal sider 4
ISSN 0895-4356
DOI
Status Udgivet - jun. 2021

OBJECTIVE: To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19.

DESIGN: Non-drug, open label, randomised controlled trial.

SETTING: Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021.

PARTICIPANTS: Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19.

INTERVENTION: Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention.

MAIN OUTCOME MEASURES: Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days' follow-up.

RESULTS: 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of -1.2 points (95% confidence interval -2.1 to -0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported.

CONCLUSIONS: In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04530435.

Originalsprog Engelsk
Artikelnummer e066952
Tidsskrift BMJ
Vol/bind 375
Sider (fra-til) 1-9
Antal sider 9
ISSN 1756-1833
DOI
Status Udgivet - 24 nov. 2021

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.

Effect of real-time and post-event feedback in out-of-hospital cardiac arrest attended by EMS - A systematic review and meta-analysis

Lyngby, R. M., Händel, M. N., Christensen, A. M., Nikoletou, D., Folke, F., Christensen, H. C., Barfod, C. & Quinn, T., jun. 2021, I: Resuscitation plus. 6, s. 100101

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Objectives: A systematic review to determine if cardiopulmonary resuscitation (CPR) guided by either real-time or post-event feedback could improve CPR quality or patient outcome compared to unguided CPR in out-of-hospital cardiac arrest (OHCA).

Methods: Four databases were searched; PubMed, Embase, CINAHL, and Cochrane Library in August 2020 for post 2010 literature on OHCA in adults. Critical outcomes were chest compression depth, rate and fraction. Important outcomes were any return of spontaneous circulation, survival to hospital and survival to discharge.

Results: A total of 9464 studies were identified with 61 eligibility for full text screening. A total of eight studies was included in the meta-analysis. Five studies investigated real-time feedback and three investigated post-event feedback. Meta-analysis revealed that real-time feedback statistically improves compression depth and rate while post-event feedback improved depth and fraction. Feedback did not statistically improve patient outcome but an improvement in absolute numbers revealed a clinical effect of feedback. Heterogenity varied from "might not be important" to "considerable".

Conclusion: To significantly improve CPR quality real-time and post-event feedback should be combined. Neither real-time nor post event feedback could statistically be associated with patient outcome however, a clinical effect was detected. The conclusions reached were based on few studies of low to very low quality.

PROSPERO registration: CRD42019133881.

Originalsprog Engelsk
Tidsskrift Resuscitation plus
Vol/bind 6
Sider (fra-til) 100101
ISSN 2666-5204
DOI
Status Udgivet - jun. 2021

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