Published in 2021

Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial

Bruun, K. D., Amris, K., Vaegter, H. B., Blichfeldt-Eckhardt, M. R., Holsgaard-Larsen, A., Christensen, R. & Toft, P., 15 nov. 2021, I: Trials. 22, 1, s. 804 804.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia.

METHODS: A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18-64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers.

DISCUSSION: This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia.

TRIAL REGISTRATION: EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020.

Originalsprog Engelsk
Artikelnummer 804
Tidsskrift Trials
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 804
ISSN 1745-6215
DOI
Status Udgivet - 15 nov. 2021

Bibliografisk note

© 2021. The Author(s).

Lung ultrasound as a prognostic tool in emergency patients clinically suspected of COVID-19

Bock, A., Lassen, A. T., Laursen, C. B. & Posth, S., 7 jan. 2021, I: Danish Medical Journal. 68, 2

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Lyme arthritis is rare in Eastern Denmark

Müller, T., Locht, H., Panum, I., Nielsen, L. & Jensen, B., 1 nov. 2021, I: Danish Medical Journal. 68, 11, s. 1-7 7 s., A05210423.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION The multi-organ disease Lyme borreliosis can cause mainly large joint arthritis. No guideline exists describing how to diagnose Lyme arthritis (LA). The incidence of LA in Denmark remains unknown, but it is considered to be low. The primary aim of this study was to quantify the number of Borrelia burgdorferi serological tests requested from primary and secondary care; secondly, to examine how often LA is diagnosed. METHODS this was a register-based study including B. burgdorferi serological tests analysed at the department of clinical microbiology at Hvidovre and Herlev Hospitals during a two-year period. The results of the tests were categorised into primary and secondary care. A medical record review was made covering all newly referred rheumatological patients with B. burgdorferi serological tests analysed the Department of Clinical Microbiology, Hvidovre Hospital. A model was set up to diagnose LA. RESULTS Most tests were requested by primary care. A total of 146 rheumatology patients were tested for B. burgdorferi of whom 118 were newly referred. Using our model to diagnose LA, we found that three patients had possible LA, whereas one had likely LA, but none were given a final LA diagnosis. Overdiagnosis was not common among rheumatologists. CONCLUSION. The number of requested B. burgdorferi serological tests was highest in primary care. A clear guideline describing how to diagnose LA is needed in primary and secondary care alike.

Originalsprog Engelsk
Artikelnummer A05210423
Tidsskrift Danish Medical Journal
Vol/bind 68
Udgave nummer 11
Sider (fra-til) 1-7
Antal sider 7
ISSN 1603-9629
Status Udgivet - 1 nov. 2021

Bibliografisk note

Publisher Copyright:
© 2021, Almindelige Danske Laegeforening. All rights reserved.

Human health effects of airborne lower-chlorinated polychlorinated biphenyls (LC-PCBs) are largely unexplored. Since PCBs may cross the placenta, maternal exposure could potentially have negative consequences for fetal development. We aimed to determine if exposure to airborne PCB during pregnancy was associated with adverse birth outcomes. In this cohort study, exposed women had lived in PCB contaminated apartments at least one year during the 3.6 years before conception or the entire first trimester of pregnancy. The women and their children were followed for birth outcomes in Danish health registers. Logistic regression was performed to estimate odds ratios (OR) for changes in secondary sex ratio, preterm birth, major congenital malformations, cryptorchidism, and being born small for gestational age. We performed linear regression to estimate difference in birth weight among children of exposed and unexposed mothers. All models were adjusted for maternal age, educational level, ethnicity, and calendar time. We identified 885 exposed pregnancies and 3327 unexposed pregnancies. Relative to unexposed women, exposed women had OR 0.97 (95% CI 0.82, 1.15) for secondary sex ratio, OR 1.13 (95% CI 0.76, 1.67) for preterm birth, OR 1.28 (95% CI 0.81, 2.01) for having a child with major malformations, OR 1.73 (95% CI 1.01, 2.95) for cryptorchidism and OR 1.23 (95% CI 0.88, 1.72) for giving birth to a child born small for gestational age. The difference in birth weight for children of exposed compared to unexposed women was - 32 g (95% CI-79, 14). We observed an increased risk of cryptorchidism among boys after maternal airborne LC-PCB exposure, but due to the proxy measure of exposure, inability to perform dose-response analyses, and the lack of comparable literature, larger cohort studies with direct measures of exposure are needed to investigate the safety of airborne LC-PCB exposure during pregnancy.

Originalsprog Engelsk
Tidsskrift European Journal of Epidemiology
Vol/bind 36
Udgave nummer 8
Sider (fra-til) 861-872
Antal sider 12
ISSN 0393-2990
DOI
Status Udgivet - aug. 2021

Bibliografisk note

© 2021. The Author(s).

Maternal use of hormonal contraception and epilepsy in offspring

Halane, H. I. M., Hargreave, M., Kjaer, S. K., Christensen, J. & Mørch, L. S., 17 maj 2021, I: Human Reproduction. 36, 6, s. 1674-1681 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

MCM3 upregulation confers endocrine resistance in breast cancer and is a predictive marker of diminished tamoxifen benefit

Løkkegaard, S., Elias, D., Alves, C. L., Bennetzen, M. V., Lænkholm, A-V., Bak, M., Gjerstorff, M. F., Johansen, L. E., Vever, H., Bjerre, C., Kirkegaard, T., Nordenskjöld, B., Fornander, T., Stål, O., Lindström, L. S., Esserman, L. J., Lykkesfeldt, A. E., Andersen, J. S., Leth-Larsen, R. & Ditzel, H. J., 4 jan. 2021, I: Current Medical Literature. Breast Cancer. 7, 1, s. 2

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Measurement properties of radiographic outcome measures in Psoriatic Arthritis: A systematic review from the GRAPPA-OMERACT initiative

Antony, A., Holland, R., D'Agostino, M-A., Maksymowych, W. P., Bertheussen, H., Schick, L., Goel, N., Ogdie, A., Orbai, A-M., Højgaard, P., Coates, L. C., Strand, V., Gladman, D. D., Christensen, R., Leung, Y. Y., Mease, P. & Tillett, W., apr. 2021, I: Seminars in Arthritis and Rheumatism. 51, 2, s. 367-386 20 s.

Publikation: Bidrag til tidsskriftReviewpeer review

BACKGROUND: Structural damage is as an important outcome in the Psoriatic Arthritis (PsA) Core Domain Set and its assessment is recommended at least once in the development of a new drug.

OBJECTIVES: To conduct a systematic review (SR) to identify studies addressing the measurement properties of radiographic outcome instruments for structural damage in PsA and appraise the evidence through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Framework Instrument Selection Algorithm (OFISA).

METHODS: A SR was conducted using search strategies in EMBASE and MEDLINE to identify full-text English studies which aimed to develop or assess the measurement properties of radiographic outcome instruments in PsA. Determination of eligibility and data extraction was performed independently by two reviewers with input from a third to achieve consensus. Two reviewers assessed the methodology and results of eligible studies and synthesized the evidence using OMERACT methodology.

RESULTS: Twelve articles evaluating radiographic instruments were included. The articles assessed nine peripheral (hands, wrists and/or feet) and six axial (spinal and/or sacroiliac joints) radiographic instruments. The peripheral radiographic instruments with some evidence for reliability, cross-sectional construct validity and longitudinal construct validity were the Ratingen and modified Sharp van der Heijde scores. No instruments had evidence for clinical trial discrimination or thresholds of meaning. There was limited evidence for the measurement properties of all identified axial instruments.

CONCLUSION: There are significant knowledge gaps in the responsiveness of peripheral radiographic instruments. Axial radiographic instruments require further validation, and the need to generate novel instruments and utilise other imaging modalities should be considered.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 2
Sider (fra-til) 367-386
Antal sider 20
ISSN 0049-0172
DOI
Status Udgivet - apr. 2021

Measuring self-reported ability to perform activities of daily living: a Rasch analysis

Wæhrens, E. E., Kottorp, A. & Nielsen, K. T., 18 okt. 2021, I: Health and Quality of Life Outcomes. 19, 1, s. 243 243.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Since the number of persons diagnosed with multi-morbidity is increasing, there is a need for generic instruments to be able to assess, measure and compare ADL ability across diagnoses. Accordingly, the ADL-Interview (ADL-I) was developed to be used in rehabilitation research and clinical practice. The aim of this study was to investigate if the ADL-I can be used to provide valid and reliable ADL ability measures across gender and diagnostic groups. Methods: ADL-I data were extracted from an existing research database on persons with chronic conditions including medical, rheumatological, oncological, neurological, geriatric and psychiatric diagnoses. Data were analysed based on Rasch Measurement methods to examine: the psychometric properties of the rating scale; ADL item and person fit to the Rasch model; if the difficulty of the ADL tasks differs across gender and diagnostic groups, and if the ADL-I provides precise and reliable measures of ADL ability. Results: Data on n = 2098 persons were included in the final analysis. Initial evaluation of the 0–3 rating scale revealed threshold disordering between categories 1 and 2. After removal of 16 underfitting items, the variance explained by the Rasch dimension increased from 54.3 to 58.0%, thresholds were ordered, but the proportion of persons with misfitting ADL-I measures increased slightly from 8.7 to 9.1%. The person separation index improved slightly from 2.75 to 2.99 (reliability = 0.90). Differential test function analysis, however, supported that the 16 underfitting items did not represent a threat to the measurement system. Similarly, ADL items displaying differential item functioning across gender and diagnoses did not represent a threat to the measurement system. The ADL items and participants were well distributed along the scale, with item and person measures well targeted to each other, indicating a small ceiling effect and no floor effect. Conclusions: The study results overall suggest that the ADL-I is producing valid and reliable measures across gender and diagnostic groups among persons within a broad range of ADL ability, providing evidence to support generic use of the ADL-I. Trial registration: N/A.

Originalsprog Engelsk
Artikelnummer 243
Tidsskrift Health and Quality of Life Outcomes
Vol/bind 19
Udgave nummer 1
Sider (fra-til) 243
ISSN 1477-7525
DOI
Status Udgivet - 18 okt. 2021

Bibliografisk note

Funding Information:
This work was supported by the Danish Association of Occupational Therapists [PP2 – R70- A1509] and The Oak Foundation [OCAY-18-774-OFIL].

Publisher Copyright:
© 2021, The Author(s).

Mechanical forces and Hidradenitis Suppurativa

Boer, J. & Jemec, G. B. E., feb. 2021, I: Experimental Dermatology. 30, 2, s. 212-215 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Mental illness, ethnicity and civil status are associated with nonattendance in diabetic retinopathy screening among people with type 2 diabetes

Petersen, G. B., Byberg, S., Fangel, M. V., Vistisen, D., Joensen, L. E., Vorum, H. & Kristensen, J. K., 2021, I: Diabetologica. 64, Suppl. 1

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Metascoring Hidradenitis suppurativa

Daoud, M., Njimi, H., Benhadou, F., Suppa, M., Daxhelet, M., Karama, J., White, J., Jemec, G. B. E. & del Marmol, V., apr. 2021, I: Journal of the European Academy of Dermatology and Venereology. 35, 4, s. e272-e274

Publikation: Bidrag til tidsskriftLetterpeer review

Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review

Laigaard, J., Pedersen, C., Rønsbo, T. N., Mathiesen, O. & Karlsen, A. P. H., maj 2021, I: British Journal of Anaesthesia. 126, 5, s. 1029-1037 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Morphological Intervention for Students With Limited Vocabulary Knowledge: Short- and Long-Term Transfer Effects

Gellert, A. S., Arnbak, E., Wischmann, S. & Elbro, C., 2021, I: Reading Research Quarterly. 56, 3, s. 583-601 19 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Multi-task weak supervision enables anatomically-resolved abnormality detection in whole-body FDG-PET/CT

Eyuboglu, S., Angus, G., Patel, B. N., Pareek, A., Davidzon, G., Long, J., Dunnmon, J. & Lungren, M. P., 25 mar. 2021, I: Nature Communications. 12, 1, s. 1880

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Musculoskeletal function in anterior cruciate ligament reconstructed individuals with and without knee pain

Bandak, E., Stenroth, L., Henriksen, M., Bliddal, H., Krommes, K., Hölmich, P. & Alkjær, T., nov. 2021.

Publikation: KonferencebidragKonferenceabstrakt til konferenceForskning

Objective To compare the musculoskeletal function between anterior cruciate ligament (ACL) reconstructed individuals with and without knee pain to better understand the role of the musculoskeletal function in relation to the development of knee osteoarthritis. Study design and methods This is an observational cross-sectional study including individuals with ACL reconstruction in one knee with pain (Symptomatic, n= 50), and without knee pain (Asymptomatic, n= 50). Asymptomatic is defined as pain rating = 0 and Symptomatic ≥3 on a verbal rating scale (VRS; 0-10, higher is worse) in the reconstructed knee during activities of daily living within the last week. The main inclusion criteria consist of age between 18 to 40 years at the time of surgery, post-surgery time ≥3 years, and body mass index ≤30. The main exclusion criteria are major surgery to the other knee, musculoskeletal pain in the lower extremity other than in the ACL reconstructed knee. The primary outcome is maximal isometric quadriceps muscle strength. Secondary outcomes are knee joint biomechanics during walking/forward lunging, maximal isometric hamstring muscle strength, knee pain, pressure pain sensitivity, self-reported knee function, activity level, and radiographic knee osteoarthritis level. The statistical analysis will include a comparison between the two groups (ANCOVA).
Originalsprog Engelsk
Publikationsdato nov. 2021
Status Udgivet - nov. 2021
Begivenhed Annual Symposium: Basic and Clinical Research in Musculo-skeletal Sciences (MUSKOS) - Comwell Borupgaard, Snekkersten, Danmark
Varighed: 25 nov. 2021 → …

Seminar

Seminar Annual Symposium: Basic and Clinical Research in Musculo-skeletal Sciences (MUSKOS)
Lokation Comwell Borupgaard
Land Danmark
By Snekkersten
Periode 25/11/2021 → …

Nefrologiske bivirkninger til behandling med immuncheckpointinhibitorer

Valentin, A., Møller, AKH., Broberg, B., Hansen, D. & Palshof, JA., mar. 2021.

Publikation: KonferencebidragPosterForskning

Nephrology in Denmark

Heaf, J., Carlson, N., Povlsen, J. V., Sørensen, S. S. & Wittenhagen, P., 18 mar. 2021, Nephrology Worldwide. Springer International Publishing, s. 511-520 10 s.

Publikation: Bidrag til bog/antologi/rapportBidrag til bog/antologiForskningpeer review

Night work and incidence of Parkinson's disease in the Danish Nurse Cohort

Jørgensen, J. T., Schernhammer, E., Papantoniou, K., Hansen, J., Westendorp, R. G. J., Stayner, L., Simonsen, M. K. & Andersen, Z. J., 1 jun. 2021, I: Occupational and Environmental Medicine. 78, 6, s. 419-425 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Objectives Evidence on the association between night work and Parkinson's disease (PD) is sparse and conflicting, calling for more definitive studies. Methods We included 20 138 female nurses from the Danish Nurse Cohort without PD who at baseline in 1993 and/or 1999 reported their most common current work schedule (day, evening, night, and rotating (a combination of at least two of these)), including information on lifetime cumulative duration (years) of each shift in a 2009 follow-up survey. We obtained information on PD hospital contacts and PD medication until November 2018 via linkage to the Danish National Patient (inpatient from 1977 and outpatient contacts from 1995 onwards) and Prescription Registers starting in 1995. We defined the incidence of PD as the first-ever hospital contact due to PD, or the first-ever redeemed levodopa prescription, whichever came first. We used Cox regression models to calculate HRs and 95% CIs, adjusting for age, smoking status, coffee consumption and use of hormone replacement therapy. Results We found no significant difference in PD risk among nurses who reported working evening (HR=0.86; 95% CI=0.55 to 1.34), night (HR=1.26; 95% CI=0.79 to 2.02) or rotating shifts (HR=0.83; 95% CI=0.56 to 1.21) at cohort baseline in 1993 or 1999, when compared with permanent day workers. Similarly, persistency of shift work (working the same work schedule for 6+ years) or duration of shift work was not associated with PD risk. Conclusions Overall, there was little evidence for an association between various shift work schedules including night work and PD in this cohort of middle-aged female nurses.

Originalsprog Engelsk
Tidsskrift Occupational and Environmental Medicine
Vol/bind 78
Udgave nummer 6
Sider (fra-til) 419-425
Antal sider 7
ISSN 1351-0711
DOI
Status Udgivet - 1 jun. 2021

Bibliografisk note

Funding Information:
Funding This study was funded by The Danish Working Environment Research Fund (Grant no: 22-2017-03).

Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.

Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood

Zheng, M., Hesketh, K. D., Wu, J. H. Y., Heitmann, B. L., Downing, K. & Campbell, K. J., jul. 2021, I: Pediatric obesity. 16, 7, s. e12766 e12766.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The respective contribution of total, daytime and nighttime sleep duration in childhood obesity remains unclear.

OBJECTIVES: To assess the longitudinal association between developmental trajectories of sleep duration and BMI z-score in early childhood.

METHODS: Data were from the Melbourne INFANT program, a prospective cohort with 4-month-old infants being followed-up until age 60 months (n = 528). Sleep duration (total, daytime, nighttime) and BMI z-score were measured using questionnaire at ages 4, 9, 18, 43 and 60 months. Group-based trajectory modelling was used to describe longitudinal trajectories from ages 4 to 60 months. Multivariable logistic regression was conducted to assess the association between sleep duration and BMI z-score trajectories.

RESULTS: Three nighttime sleep duration trajectory groups were identified: "Long stable" (10.5 to 11.0 hours, 61%), "catchup long" (8.0 to 11.5 hours, 23%) and "short stable" (8.7 to 9.8 hours, 16%) nighttime sleepers. BMI z-score trajectory groups were classified as "low-BMIz" (-1.5 to -0.5 unit, 21%), "mid-BMIz" (-0.5 to 0.5 unit, 58%) and "high-BMIz" (0.8 to 1.4 unit, 21%). With adjustment for child and maternal covariates, both "catchup long" (OR 3.69 95%CI 1.74, 7.92) and "long stable" nighttime sleepers (OR 4.27 95%CI 2.21, 8.25) revealed higher odds of being in the "mid-BMIz" than the "high-BMIz" group. By contrast, total or daytime sleep duration trajectories were not associated with BMI z-score trajectories.

CONCLUSIONS: Longer nighttime, but not total or daytime, sleep duration was associated with lower BMI z-score trajectories in early childhood. Our findings reinforce the importance of nighttime sleep for healthy body-weight development in early childhood.

Originalsprog Engelsk
Artikelnummer e12766
Tidsskrift Pediatric obesity
Vol/bind 16
Udgave nummer 7
Sider (fra-til) e12766
ISSN 1524-6817
DOI
Status Udgivet - jul. 2021

Objectives: Nailfold video capillaroscopy (NVC) and angiographic optical coherence tomography (OCTA) have potential in diagnosing PsA and differentiating it from psoriasis vulgaris (PsO) and hand OA. We aimed to assess the diagnostic properties of NVC and OCTA in patients with PsA compared with patients with PsO and hand OA based on nailfold capillary patterns.

Methods: Patients with DIP joint PsA and nail involvement (n = 50), PsO with nail involvement (n = 12) and OA (n = 13) were included in this cross-sectional study. Capillaries were evaluated semi-quantitatively and qualitatively. Differences in capillary findings between groups were assessed using mixed linear models. Binary logistic regression analyses were performed to determine the probability for PsA diagnosis based on capillaroscopy findings.

Results: Below mean capillary density and reduced nailfold blood flow in OCTA images distinguished PsA from both PsO (P = 0.004 and P = 0.052, respectively) and OA (P = 0.024 and P < 0.001, respectively). Qualitative analysis revealed that glomerular capillaries were found in only 3% of PsA patients but in 13% of PsO patients (P = 0.003). Furthermore, crossed vessels were seen in only 55% of PsA patients and 71% of PsO patients (P = 0.043). NVC microhaemorrhage was dominant in PsA patients (13%) and significantly different from OA patients (P <0.05). No capillary pattern was associated with an increased probability of the PsA diagnosis.

Conclusion: A pathognomonic pattern for PsA diagnosis was not identified; however, we demonstrated some characteristic capillaroscopy findings for PsA, such as decreased capillary density, reduced blood flow and fewer crossed vessels in OCTA and presence of NVC microhaemorrhages.

Originalsprog Engelsk
Artikelnummer rkab065
Tidsskrift Rheumatology Advances in Practice
Vol/bind 5
Udgave nummer 3
Sider (fra-til) rkab065
ISSN 2514-1775
DOI
Status Udgivet - 2021

Bibliografisk note

© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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