Published in 2022

OBJECTIVES: In a 2-year follow-up study of patients with axial spondyloarthritis (axSpA) in clinical remission who tapered tumor necrosis factor inhibitor (TNFi) treatment according to a clinical guideline, we aimed to investigate the proportion who successfully tapered/discontinued therapy and baseline predictors thereof. The proportion regaining clinical remission after flare and the progression on MRI/radiography were also assessed.

METHODS: One-hundred-and-nine patients (78(72%)/31(28%) receiving standard respectively reduced dose) in clinical remission (BASDAI < 40, physician global score < 40) and no signs of disease activity the previous year tapered TNFi as follows: to two-thirds of standard dose at baseline, half at week 16, one-third at week 32 and discontinuation at week 48. Patients experiencing clinical, BASDAI or MRI flare (predefined criteria) stopped tapering and escalated to previous dose. Prediction analyses were performed by multivariable regression.

RESULTS: One-hundred-and-six patients(97%) completed 2-years follow-up; 55 patients(52%) had successfully tapered: 23(22%) receiving two-thirds, 15(14%) half, 16(15%) one-third dose and 1(1%) discontinued. In patients at standard dose at baseline(n = 78), lower physician global score was the only independent predictor of successful tapering (Odds ratio(OR)=0.79(95% Confidence Interval = 0.64-0.93); p= 0.003). In the entire patient group lower physician global score(OR = 0.86(0.75-0.98); p= 0.017), lower Spondyloarthritis Research Consortium of Canada(SPARCC) Sacroiliac Joint Erosion score(OR = 0.78(0.57-0.98); p= 0.029) and current smoking(OR = 3.28(1.15-10.57); p= 0.026) were independent predictors of successful tapering. At 2-years, 97% of patients were in clinical remission. Minimal changes in imaging findings were observed.

CONCLUSION: After two years following a clinical guideline, 52% of patients with axSpA in clinical remission had successfully tapered TNFi, only 1% discontinued. Baseline physician global score was an independent predictor of successful tapering.

Originalsprog Engelsk
Artikelnummer keab755
Tidsskrift Rheumatology (Oxford, England)
ISSN 1462-0324
DOI
Status E-pub ahead of print - 2022

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.

Several studies show an increased risk of coronary heart disease (CHD) among people with obesity, but it is largely unknown whether this association also depends on a familial predisposition to obesity. This study examined if associations between Body Mass Index (BMI) or waist circumference (WC) and incident CHD differed among Danish female nurses with and without familial overweight and obesity. Analyses were based on data from the Danish Nurse Cohort (n = 20,701). Self-reported height, weight and self-measured WC were assessed in 1999, as was information on familial overweight/obesity, defined as having one or both parents with overweight/obesity. Information on the development of or death from CHD was collected from nationwide Danish registries in 2015. Analyses were based on Cox proportional hazard regression models adjusted for potential confounding factors. Both BMI and WC were directly associated with CHD risk, but we found no evidence of effect modification from familial predisposition to obesity. Hence a familial predisposition to obesity does not seem to influence the risk of CHD associated with general or central obesity.

Originalsprog Engelsk
Tidsskrift International journal of obesity (2005)
Vol/bind 46
Udgave nummer 2
Sider (fra-til) 433-436
Antal sider 4
ISSN 0307-0565
DOI
Status Udgivet - feb. 2022

Bibliografisk note

© 2021. The Author(s), under exclusive licence to Springer Nature Limited.

The long-term association between bilateral oophorectomy and depression: a prospective cohort study

Bräuner, E. V., Wilson, L. F., Koch, T., Christensen, J., Dehlendorff, C., Duun-Henriksen, A. K., Priskorn, L., Abildgaard, J., Simonsen, M. K., Jørgensen, J. T., Lim, Y-H., Andersen, Z. J., Juul, A. & Hickey, M., mar. 2022, I: Menopause (New York, N.Y.). 29, 3, s. 276-283 8 s., 0000000000001913.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Depression is a leading cause of disability globally and affects more women than men. Ovarian sex steroids are thought to modify depression risk in women and interventions such as bilateral oophorectomy that permanently change the sex steroid milieu may increase the risk of depression. This study aimed to investigate the associations between unilateral and bilateral oophorectomy and depression over a 25-year period (1993-2018) and whether this varied by age at oophorectomy or use of menopausal hormone therapy. METHODS: Twenty-five thousand one hundred eighty-eight nurses aged ≥45 years from the Danish Nurse Cohort were included. Nurses with depression prior to baseline were excluded. Poisson regression models, with log-transformed person-years as offset, were used to assess the associations between oophorectomy and incident depression. Nurses who retained their ovaries were the reference group. RESULTS: Compared with nurses with retained ovaries, bilateral oophorectomy was associated with a slightly higher rate of depression (rate ratio [RR], 1.08; 95% confidence interval [CI], 0.95-1.23), but without statistical significance. However, when stratified by age at oophorectomy, compared with nurses with retained ovaries, bilateral oophorectomy at age ≥51 years was associated with higher rates of depression (RR 1.16; 95% CI, 1.00-1.34), but not bilateral oophorectomy at age <51 years (RR 0.86; 95% CI, 0.69-1.07); P value for difference in estimates = 0.02. No association between unilateral oophorectomy and depression was observed. CONCLUSIONS: In this cohort of Danish female nurses, bilateral oophorectomy at age ≥51 years, but not at younger ages, was associated with a slightly higher rate of depression compared with those who retained their ovaries.

Originalsprog Engelsk
Artikelnummer 0000000000001913
Tidsskrift Menopause (New York, N.Y.)
Vol/bind 29
Udgave nummer 3
Sider (fra-til) 276-283
Antal sider 8
ISSN 1072-3714
DOI
Status Udgivet - mar. 2022

Bibliografisk note

Copyright © 2022 by The North American Menopause Society.

The occurrence of multiple treatment switches in axial spondyloarthritis. Results from five Nordic rheumatology registries

Di Giuseppe, D., Lindström, U., Aaltonen, K., Relas, H., Provan, S., Gudbjornsson, B., Hetland, M. L., Askling, J., Kauppi, M., Geirsson, A. J., Chatzidionysiou, K., Jørgensen, T. S., Dreyer, L., Michelsen, B., Jacobsson, L. & Glintborg, B., 2022, (E-pub ahead of print) I: Rheumatology (Oxford, England).

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: In axial spondyloarthritis (axSpA), switching between multiple biologic or targeted synthetic (b/ts-) DMARDs might indicate difficult-to-treat disease. We aimed to explore the occurrence of multiple switching in routine care axSpA patients using various definitions, and to identify associated clinical characteristics upon start of first b/tsDMARD (baseline).

METHODS: Observational cohort study including patients with axSpA starting a first-ever b/tsDMARD 2009-2018 based on data from five biologic registries (Denmark/Sweden/Finland/Norway/Iceland). Comorbidities and extra-articular manifestations were identified through linkage to national registries. Multi-switching was defined in overlapping categories according to b/tsDMARD treatment history: treatment with ≥3 b/tsDMARDs, ≥4 or ≥ 5 b/tsDMARDs during follow-up. We explored the cumulative incidence of patients becoming multi-switchers with ≥3 b/tsDMARDs stratified by calendar-period (2009-11/2012-13/2014-15/2016-2018). In the subgroup of patients starting a first b/tsDMARD 2009-2015, baseline characteristics associated with multi-switching (within 3 years' follow-up) were explored using multiple logistic regression analyses.

RESULTS: Among 8,398 patients included, 6,056 patients (63% male, median age 42 years) started a first b/tsDMARD 2009-2015, whereof proportions treated with ≥3, ≥4 or ≥ 5 b/tsDMARDs within 3 years' follow-up were 8%, 3%, 1%, respectively.Calendar-period did not affect the cumulative incidence of multi-switching.Baseline characteristics associated with multi-switching (≥3 b/tsDMARDs) were female gender, shorter disease duration, higher patient global score, comorbidities, and having psoriasis but not uveitis.

CONCLUSION: In this large Nordic observational cohort of axSpA patients, multiple switching was frequent with no apparent time-trend. Clinical associated factors included gender, but also previous comorbidities and extraarticular manifestations illustrating the ongoing challenge of treating this patient group.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
ISSN 1462-0324
DOI
Status E-pub ahead of print - 2022

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.

C-reactive protein (CRP) has prognostic value in hospitalized patients with COVID-19; the importance of CRP in pre-hospitalized patients remains to be tested. Methods: Individuals with symptoms of COVID-19 had a SARS-CoV-2 PCR oropharyngeal swab test, and a measurement of CRP was performed at baseline, with an upper reference range of 10 mg/L. After 28 days, information about possible admissions, oxygen treatments, transfers to the ICU, or deaths was obtained from the patient files. Using logistic regression, the prognostic value of the CRP and SARS-CoV-2 test results was evaluated. Results: Among the 1006 patients included, the SARS-CoV-2 PCR test was positive in 59, and the CRP level was elevated (>10 mg/L) in 131. In total, 59 patients were hospitalized, only 3 of whom were SARS-CoV-2 positive, with elevated CRP (n = 2) and normal CRP (n = 1). The probability of being hospitalized with elevated CRP was 4.21 (95%CI 2.38-7.43, p < 0.0001), while the probability of being hospitalized with SARS-CoV-2 positivity alone was 0.85 (95%CI 0.26-2.81, p = 0.79). Conclusions: CRP is not a reliable predictor for the course of SARS-CoV-2 infection in pre-hospitalized patients. CRP, while not a SARS-CoV-2 positive test, had prognostic value in the total population of patients presenting with COVID-19-related symptoms.

Originalsprog Engelsk
Artikelnummer 201
Tidsskrift Journal of Clinical Medicine
Vol/bind 11
Udgave nummer 1
Antal sider 10
ISSN 2077-0383
DOI
Status Udgivet - 2022

Ultrasonography of Inflammatory and Structural Lesions in Hand Osteoarthritis: An OMERACT Agreement and Reliability Study

OMERACT Ultrasound Working Group, 2022, (E-pub ahead of print) I: Arthritis Care & Research.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To standardize and assess the reliability of ultrasonographic assessment of inflammatory and structural lesions in patients with hand osteoarthritis (OA).

METHODS: The Outcome Measures in Rheumatology (OMERACT) Ultrasound Working Group selected synovial hypertrophy (SH), joint effusion (JE), and power Doppler (PD) signals as the main inflammatory lesions in hand OA, and suggested osteophytes in the scapho-trapezio-trapezoid (STT) and cartilage defects in the proximal interphalangeal (PIP) joints as novel additions to previous structural scoring systems. A complementary imaging atlas provided detailed examples of the scores. A reliability exercise of static images was performed for the inflammatory features, followed by a patient-based exercise with six sonographers testing inflammatory and structural features in twelve hand OA patients. We used Cohen's kappa (κ) for intra-reader and Light's κ for inter-reader reliability for all features except PD, in which Prevalence-Adjusted Bias-Adjusted Kappa (PABAK) was applied. Percentage agreement was also assessed.

RESULTS: The web-based reliability exercise demonstrated substantial intra- and inter-reader reliability for all inflammatory features (κ>0.64). In the patient-based exercise, intra- and inter-reader reliability varied: SH κ=0.73 and 0.45; JE κ=0.70 and 0.55; PD PABAK=0.90 and 0.88; PIP cartilage κ=0.56 and 0.45; STT osteophytes κ=0.62 and 0.36. Percentage close agreement was high for all features (>85%).

CONCLUSION: With ultrasound, substantial to excellent intra-reader reliability was found for inflammatory features of hand OA. Inter-reader reliability was moderate, but overall high close agreement between readers suggest that better reliability is achievable after further training. Assessment of osteophytes in the STT joint and cartilage in the PIP joints achieved less good reliability and the latter is not endorsed.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
ISSN 2151-464X
DOI
Status E-pub ahead of print - 2022

Bibliografisk note

© 2021 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.

Users' Experiences With the NoHoW Web-Based Toolkit With Weight and Activity Tracking in Weight Loss Maintenance: Long-term Randomized Controlled Trial

Mattila, E., Bundgaard, L., Ramsey, L., Dunning, A., Silva, M. N., Harjumaa, M., Ermes, M., Marques, M. M., Matos, M., Larsen, S. C., Encantado, J., Santos, I., Horgan, G., O'Driscoll, R., Turicchi, J., Duarte, C., Palmeira, A. L., Stubbs, R. J., Heitmann, B. L. & Lähteenmäki, L., 10 jan. 2022, I: Journal of Medical Internet Research. 24, 1, s. e29302 e29302.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Digital behavior change interventions (DBCIs) offer a promising channel for providing health promotion services. However, user experience largely determines whether they are used, which is a precondition for effectiveness.

OBJECTIVE: The primary aim of this study is to evaluate user experiences with the NoHoW Toolkit (TK)-a DBCI that targets weight loss maintenance-over a 12-month period by using a mixed methods approach and to identify the main strengths and weaknesses of the TK and the external factors affecting its adoption. The secondary aim is to objectively describe the measured use of the TK and its association with user experience.

METHODS: An 18-month, 2×2 factorial randomized controlled trial was conducted. The trial included 3 intervention arms receiving an 18-week active intervention and a control arm. The user experience of the TK was assessed quantitatively through electronic questionnaires after 1, 3, 6, and 12 months of use. The questionnaires also included open-ended items that were thematically analyzed. Focus group interviews were conducted after 6 months of use and thematically analyzed to gain deeper insight into the user experience. Log files of the TK were used to evaluate the number of visits to the TK, the total duration of time spent in the TK, and information on intervention completion.

RESULTS: The usability level of the TK was rated as satisfactory. User acceptance was rated as modest; this declined during the trial in all the arms, as did the objectively measured use of the TK. The most appreciated features were weekly emails, graphs, goal setting, and interactive exercises. The following 4 themes were identified in the qualitative data: engagement with features, decline in use, external factors affecting user experience, and suggestions for improvements.

CONCLUSIONS: The long-term user experience of the TK highlighted the need to optimize the technical functioning, appearance, and content of the DBCI before and during the trial, similar to how a commercial app would be optimized. In a trial setting, the users should be made aware of how to use the intervention and what its requirements are, especially when there is more intensive intervention content.

TRIAL REGISTRATION: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-029425.

Originalsprog Engelsk
Artikelnummer e29302
Tidsskrift Journal of Medical Internet Research
Vol/bind 24
Udgave nummer 1
Sider (fra-til) e29302
ISSN 1439-4456
DOI
Status Udgivet - 10 jan. 2022

Bibliografisk note

©Elina Mattila, Susanne Hansen, Lise Bundgaard, Lauren Ramsey, Alice Dunning, Marlene N Silva, Marja Harjumaa, Miikka Ermes, Marta M Marques, Marcela Matos, Sofus C Larsen, Jorge Encantado, Inês Santos, Graham Horgan, Ruairi O'Driscoll, Jake Turicchi, Cristiana Duarte, António L Palmeira, R James Stubbs, Berit Lilienthal Heitmann, Liisa Lähteenmäki. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 10.01.2022.

BACKGROUND: Low vitamin D in pregnancy may impair the development of the fetal immune system and influence the risk of later development of rheumatoid arthritis (RA) in the offspring. The aim was to examine whether lower 25-hydroxyvitamin D3 (25(OH)D) concentrations at birth were associated with the risk of developing RA in early adulthood.

METHODS: This case-cohort study obtained data from Danish registers and biobanks. Cases included all individuals born during 1981-1996 and recorded in the Danish National Patient Register with a diagnosis of RA with age &gt;18 years at first admission. The random comparison consisted of a subset of Danish children. Vitamin D concentrations were measured in newborn dried blood. In total, 805 RA cases and 2416 individuals from the subcohort were included in the final analysis. Weighted Cox regression was used to calculate hazard ratio (HR).

RESULTS: The median (interquartile rage (IQR)) 25(OH)D concentrations among cases were 24.9 nmol/L (IQR:15.4;36.9) and 23.9 nmol/L (IQR:13.6;36.4) among the subcohort. There was no indication of a lower risk of RA among individuals in the highest vitamin D quintile compared with the lowest (HRadj.:1.21 (0.90;1.63)).

CONCLUSION: The risk of RA in early adulthood was not associated with vitamin D concentrations at birth.

Originalsprog Engelsk
Artikelnummer 447
Tidsskrift Nutrients
Vol/bind 14
Udgave nummer 3
ISSN 2072-6643
DOI
Status Udgivet - 20 jan. 2022

Writing up your clinical trial report for a scientific journal: the REPORT trial guide for effective and transparent research reporting without spin

Bandholm, T., Thorborg, K., Ardern, C. L., Christensen, R. & Henriksen, M., 22 feb. 2022, (E-pub ahead of print) I: British Journal of Sports Medicine. s. 1-10 10 s., 105058.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

The REPORT guide is a 'How to' guide to help you report your clinical research in an effective and transparent way. It is intended to supplement established first choice reporting tools, such as Consolidated Standards of Reporting Trials (CONSORT), by adding tacit knowledge (ie, learnt, informal or implicit knowledge) about reporting topics that we have struggled with as authors or see others struggle with as journal reviewers or editors. We focus on the randomised controlled trial, but the guide also applies to other study designs. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing and more. Preprint (open access): https://doi.org/10.31219/osf.io/qsxdz.

Originalsprog Engelsk
Artikelnummer 105058
Tidsskrift British Journal of Sports Medicine
Sider (fra-til) 1-10
Antal sider 10
ISSN 0306-3674
DOI
Status E-pub ahead of print - 22 feb. 2022

Bibliografisk note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Published in 2021

'Standing together - at a distance': Documenting changes in mental-health indicators in Denmark during the COVID-19 pandemic

Clotworthy, A., Dissing, A. S., Nguyen, T-L., Jensen, A. K., Andersen, T. O., Bilsteen, J. F., Elsenburg, L. K., Keller, A., Kusumastuti, S., Mathisen, J., Mehta, A., Pinot de Moira, A., Rod, M. H., Skovdal, M., Strandberg-Larsen, K., Tapager, I. W., Varga, T. V., Vinther, J. L., Xu, T., Hoeyer, K. & Hulvej Rod, N., feb. 2021, I: Scandinavian Journal of Public Health. Supplement. 49, 1, s. 79-87 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Aims: There is a need to document the mental-health effects of the COVID-19 pandemic and its associated societal lockdowns. We initiated a large mixed-methods data collection, focusing on crisis-specific worries and mental-health indicators during the lockdown in Denmark. Methods: The study incorporated five data sources, including quantitative surveys and qualitative interviews. The surveys included a time series of cross-sectional online questionnaires starting on 20 March 2020, in which 300 (3×100) Danish residents were drawn every three days from three population groups: the general population (N=1046), families with children (N=1032) and older people (N=1059). These data were analysed by trend analysis. Semi-structured interviews were conducted with 32 people aged 24-83 throughout Denmark to provide context to the survey results and to gain insight into people's experiences of the lockdown. Results: Absolute level of worries, quality of life and social isolation were relatively stable across all population groups during the lockdown, although there was a slight deterioration in older people's overall mental health. Many respondents were worried about their loved ones' health (74-76%) and the potential long-term economic consequences of the pandemic (61-66%). The qualitative interviews documented significant variation in people's experiences, suggesting that the lockdown's effect on everyday life had not been altogether negative. Conclusions: People in Denmark seem to have managed the lockdown without alarming changes in their mental health. However, it is important to continue investigating the effects of the pandemic and various public-health measures on mental health over time and across national contexts.

Originalsprog Engelsk
Bogserie Scandinavian Journal of Public Health. Supplement
Vol/bind 49
Udgave nummer 1
Sider (fra-til) 79-87
Antal sider 9
ISSN 1403-4956
DOI
Status Udgivet - feb. 2021

A biomarker perspective on the acute effect of exercise with and without impact on joint tissue turnover: an exploratory randomized cross-over study

Bjerre-Bastos, J. J., Nielsen, H. B., Andersen, J. R., Karsdal, M., Boesen, M., Mackey, A. L., Byrjalsen, I., Thudium, C. S. & Bihlet, A. R., okt. 2021, I: European Journal of Applied Physiology. 121, 10, s. 2799-2809 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Purpose: To investigate acute changes in biochemical markers of bone and cartilage turnover in response to moderate intensity exercise with and without joint impact in healthy human subjects.

Methods: A randomized, cross-over, exploratory, clinical study was conducted. Twenty healthy subjects with no history of joint trauma completed 30 min interventions of standardized moderate intensity cycling and running as well as a resting intervention 1 week apart. Blood samples were taken immediately before, four times after exercise and again the next day. Urine was sampled, before, after and the next day. On the day of rest, samples were taken at timepoints similar to the days of exercise. Markers of type I (CTX-I), II (C2M, CTX-II) and VI (C6M) collagen degradation, cartilage oligomeric matrix protein (COMP) and procollagen C-2 (PRO-C2) was measured.

Trial registration number: NCT04542655, 02 September 2020, retrospectively registered.

Results: CTX-I was different from cycling (4.2%, 95%CI: 0.4-8.0%, p = 0.03) and resting (6.8%, 95%CI: 2.9-10.7%, p = 0.001) after running and the mean change in COMP was different from cycling (10.3%, 95%CI: 1.1-19.5%, p = 0.03), but not from resting (8.6%, 95%CI: - 0.7-17.8%, p = 0.07) after running. Overall, changes in other biomarkers were not different between interventions.

Conclusion: In this exploratory study, running, but not cycling, at a moderate intensity and duration induced acute changes in biomarkers of bone and cartilage extra-cellular matrix turnover.

Originalsprog Engelsk
Tidsskrift European Journal of Applied Physiology
Vol/bind 121
Udgave nummer 10
Sider (fra-til) 2799-2809
Antal sider 11
ISSN 1439-6319
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Funding Information:
JJB received funding from Nordic Bioscience Clinical Development and the Danish Research Fund. IB and CT are full-time employees of Nordic Bioscience. JRA, MK and ARB are full-time employees and shareholders of Nordic Bioscience. MB and ALM have no conflict of interest.

Funding Information:
This study was funded by Nordic Bioscience Clinical Development and the Danish Research Fund.

Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

A new tool to assess Clinical Diversity In Meta-analyses (CDIM) of interventions

Barbateskovic, M., Koster, T. M., Eck, R. J., Maagaard, M., Afshari, A., Blokzijl, F., Cronhjort, M., Dieperink, W., Fabritius, M. L., Feinberg, J., French, C., Gareb, B., Geisler, A., Granholm, A., Hiemstra, B., Hu, R., Imberger, G., Jensen, B. T., Jonsson, A. B., Karam, O., Kong, D. Z., Korang, S. K., Koster, G., Lai, B., Liang, N., Lundstrøm, L. H., Marker, S., Meyhoff, T., Nielsen, E. E., Nørskov, A. K., Munch, M. W., Risom, E. C., Rygård, S. L., Safi, S., Sethi, N., Sjövall, F., Lauridsen, S. V., van Bakelen, N., Volbeda, M., van der Horst, I., Gluud, C., Perner, A., Møller, M. H., Keus, F. & Wetterslev, J., jul. 2021, I: Journal of Clinical Epidemiology. 135, s. 29-41 13 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions.

STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups.

RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age; sex; patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention; timing; control intervention; cointerventions);and outcome (definition of outcome; timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters.

CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 135
Sider (fra-til) 29-41
Antal sider 13
ISSN 0895-4356
DOI
Status Udgivet - jul. 2021
Originalsprog Engelsk
Tidsskrift Archives of Physiotherapy
ISSN 2057-0082
Status Afsendt - jun. 2021

A systematic review and meta-analysis of observational studies on the association between animal protein sources and risk of rheumatoid arthritis

Asoudeh, F., Jayedi, A., Kavian, Z., Ebrahimi-Mousavi, S., Nielsen, S. M. & Mohammadi, H., jul. 2021, I: Clinical nutrition (Edinburgh, Scotland). 40, 7, s. 4644-4652 9 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: The aim of this study was to investigate the linear and nonlinear dose-response associations of animal-based dietary protein intake and risk of developing rheumatoid arthritis (RA).

METHODS: A systematic search of MEDLINE, Scopus and Embase was conducted up to October 2020. Observational studies that report risk estimates of RA for animal-based protein consumption were included. We calculated pooled relative risks (RRs) by using a random-effects model. Linear and non-linear dose-response analyses were performed to examine the dose-response relations between animal-based protein consumption and RA.

RESULTS: Seven cohort studies (n = 457,554) with 3545 incident cases and six case-control studies with 3994 cases and 5252 controls were identified. Highest compared with the lowest category of fish consumption was inversely associated with risk of RA (RR: 0.89; 95% CI, 0.80 to 0.99; I2 = 0%, n = 10). Also, a 100 g/day increment in fish intake was associated with a 15% decreased risk of RA. Dose-response analysis showed a modest U-shaped association between fish consumption and incidence of RA, with the lowest risk at a fish intake of 20-30 g/day (Pnon-linearity = 0.04). We found no significant association between consumption of red meat, poultry or dairy and the risk of RA.

CONCLUSION: The present study revealed a significant reverse association between fish consumption and risk of RA. While we observed no association between red meat, dairy or poultry consumption and risk of RA. Further well-designed prospective studies are needed to support our findings.

Originalsprog Engelsk
Tidsskrift Clinical nutrition (Edinburgh, Scotland)
Vol/bind 40
Udgave nummer 7
Sider (fra-til) 4644-4652
Antal sider 9
ISSN 0261-5614
DOI
Status Udgivet - jul. 2021

A Systematic Review of Job Loss Prevention Interventions for Persons with Inflammatory Arthritis

Madsen, C. M. T., Bisgaard, S. K., Primdahl, J., Christensen, J. R. & von Bülow, C., dec. 2021, I: Journal of Occupational Rehabilitation. 31, 4, s. 866-885 20 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Purpose To present an overview of the evidence of the effect of job loss prevention interventions, aiming to improve work ability and decrease absenteeism and/or job loss in persons with inflammatory arthritis (IA). Method A systematic literature search in the databases PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library was conducted. A search strategy used in a review from 2014 was copied and additional keywords were added with no time restriction. The Cochrane Risk of Bias Tool (RoB 1) was used for quality assessment and the overall quality of each study was determined using predetermined cut-off criteria, categorising studies to be of good-, acceptable- or low quality. Results were summarised narratively. Results Six randomised controlled trials (published in seven articles) were included, one of good quality and five of acceptable quality. One study identified significant improvements in work ability, while three found no significant difference between groups. One study identified significant difference in absenteeism, while two studies identified no difference between the intervention and control groups. Two studies identified significant reduction in job loss, while two studies identified no group difference. The inconsistent results may be due to heterogeneity in interventions and outcome measures used, and the results should therefore be interpreted with caution. Conclusion The results indicate that job loss prevention interventions may have an effect on work ability, absenteeism and in particular job loss among persons with IA. Further good-quality studies regarding job loss prevention interventions for people with IA are still recommended.

Originalsprog Engelsk
Tidsskrift Journal of Occupational Rehabilitation
Vol/bind 31
Udgave nummer 4
Sider (fra-til) 866-885
Antal sider 20
ISSN 1053-0487
DOI
Status Udgivet - dec. 2021

Bibliografisk note

Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study

Marques, M. M., Matos, M., Mattila, E., Encantado, J., Duarte, C., Teixeira, P. J., Stubbs, R. J., Sniehotta, F. F., Ermes, M., Harjumaa, M., Leppänen, J., Välkkynen, P., Silva, M. N., Ferreira, C., Carvalho, S., Palmeira, L., Horgan, G., Heitmann, B. L., Evans, E. H. & Palmeira, A. L., 3 dec. 2021, I: Journal of Medical Internet Research. 23, 12, s. e25305 e25305.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union's Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention.

OBJECTIVE: This paper aims to describe the development of the NoHoW Toolkit, focusing on the logic models, content, and specifications, as well as the results from user testing.

METHODS: The toolkit was developed by using a systematic approach, which included the development of the theory-based logic models, the selection of behavior change techniques, the translation of these techniques into a web-based app (NoHoW Toolkit components), technical development, and the user evaluation and refinement of the toolkit.

RESULTS: The toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers) and modules that targeted weight, physical activity, and dietary behaviors. The final toolkit comprised 34 sessions that were distributed through 15 modules and provided active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full toolkit (15 modules; 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Furthermore, the toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood, and sleep.

CONCLUSIONS: A systematic approach to the development of digital solutions based on theory, evidence, and user testing may significantly contribute to the advancement of the science of behavior change and improve current solutions for sustained weight management. Testing the toolkit by using a 2×2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance.

Originalsprog Engelsk
Artikelnummer e25305
Tidsskrift Journal of Medical Internet Research
Vol/bind 23
Udgave nummer 12
Sider (fra-til) e25305
ISSN 1439-4456
DOI
Status Udgivet - 3 dec. 2021

Bibliografisk note

©Marta M Marques, Marcela Matos, Elina Mattila, Jorge Encantado, Cristiana Duarte, Pedro J Teixeira, R James Stubbs, Falko F Sniehotta, Miikka Ermes, Marja Harjumaa, Juha Leppänen, Pasi Välkkynen, Marlene N Silva, Cláudia Ferreira, Sérgio Carvalho, Lara Palmeira, Graham Horgan, Berit Lilienthal Heitmann, Elizabeth H Evans, António L Palmeira. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.12.2021.

This study reports age- and sex-specific incidence rates of juvenile idiopathic arthritis (JIA) in complete Danish birth cohorts from 1992 through 2002. Data were obtained from the Danish registries. All persons born in Denmark, from 1992-2002, were followed from birth and until either the date of first diagnosis recording, death, emigration, 16th birthday or administrative censoring (17 May 2017), whichever came first. The number of incident JIA cases and its incidence rate (per 100,000 person-years) were calculated within sex and age group for each of the birth cohorts. A multiplicative Poisson regression model was used to analyze the variation in the incidence rates by age and year of birth for boys and girls separately. The overall incidence of JIA was 24.1 (23.6-24.5) per 100,000 person-years. The rate per 100,000 person-years was higher among girls (29.9 (29.2-30.7)) than among boys (18.5 (18.0-19.1)). There were no evident peaks for any age group at diagnosis for boys but for girls two small peaks appeared at ages 0-5 years and 12-15 years. This study showed that the incidence rates of JIA in Denmark were higher for girls than for boys and remained stable over the observed period for both sexes.

Originalsprog Engelsk
Artikelnummer 8331
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 18
Udgave nummer 16
ISSN 1661-7827
DOI
Status Udgivet - 6 aug. 2021

Appraisal of Candidate Instruments for Assessment of the Physical Function Domain in Patients with Psoriatic Arthritis

Leung, Y. Y., Orbai, A-M., Ogdie, A., Hojgaard, P., Holland, R., Goel, N., Chau, J., Coates, L. C., Strand, V., Gladman, D. D., Mease, P. J., Christensen, R. & Tillett, W., 1 jan. 2021, I: Journal of Rheumatology. 48, 1, s. 58-66 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Numerous patient-reported outcome measures (PROM) exist for the measurement of physical function for psoriatic arthritis (PsA), but only a few are validated comprehensively. The objective of this project was to prioritize PROM for measuring physical function for potential incorporation into a standardized outcome measurement set for PsA.

METHODS: A working group of 13 members including 2 patient research partners was formed. PROM measuring physical function in PsA were identified through a systematic literature review and recommendations by the working group. The rationale for inclusion and exclusion from the original list of existing PROM was thoroughly discussed and 2 rounds of Delphi exercises were conducted to achieve consensus.

RESULTS: Twelve PROM were reviewed and discussed. Six PROM were prioritized: Health Assessment Questionnaire (HAQ) and 4 modifications (HAQ-Disability Index, HAQ-Spondyloarthritis, modified HAQ, multidimensional HAQ), Medical Outcomes Study 36-item Short Form survey physical functioning domain, and the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning module.

CONCLUSION: Through discussion and Delphi exercises, we achieved consensus to prioritize 6 physical function PROM for PsA. These 6 PROM will undergo further appraisal using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 48
Udgave nummer 1
Sider (fra-til) 58-66
Antal sider 9
ISSN 0315-162X
DOI
Status Udgivet - 1 jan. 2021

By utilizing historical changes in Danish legislation related to mandatory vitamin D fortification of margarine, which was implemented in the mid 1930s and abruptly abandoned in June 1985, the studies in the D-tect project investigated the effects of vitamin D on health outcomes in individuals, who during gestation were exposed or unexposed to extra vitamin D from fortified margarine. This paper reviews and narratively summarizes the analytic approaches alongside the results of the societal fortification experiment studies from the D-tect project and addresses the challenges in designing societal experiment studies and evaluating their results. The latter are discussed as lessons learned that may be useful for designers of similar studies, expected to be extensively utilized while researching the health consequences of the COVID-19 pandemic by comparing individuals born before and after the epidemic. In the D-tect project, 16 articles based on the societal fortification experiment were published analyzing 10 different outcomes and using different statistical approaches. Lessons learned included the detail of the analysis of the historical information on the exposure, availability and validity of the outcome data, variety of analytical approaches, and specifics concerning vitamin D effect evaluation, such as consideration of the influence of sunshine or season. In conclusion, the D-tect project clearly demonstrated the cost-effectiveness and research potential of natural- or societal-experiment-based studies.

Originalsprog Engelsk
Artikelnummer 8136
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 18
Udgave nummer 15
ISSN 1661-7827
DOI
Status Udgivet - 31 jul. 2021

Assessing methods for evaluating the number of components in non-negative matrix factorization

Maisog, J. M., Demarco, A. T., Devarajan, K., Young, S., Fogel, P. & Luta, G., 1 nov. 2021, I: Mathematics. 9, 22, 2840.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Non-negative matrix factorization is a relatively new method of matrix decomposition which factors an m × n data matrix X into an m × k matrix W and a k × n matrix H, so that X ≈ W × H. Importantly, all values in X, W, and H are constrained to be non-negative. NMF can be used for dimensionality reduction, since the k columns of W can be considered components into which X has been decomposed. The question arises: how does one choose k? In this paper, we first assess methods for estimating k in the context of NMF in synthetic data. Second, we examine the effect of normalization on this estimate’s accuracy in empirical data. In synthetic data with orthogonal underlying components, methods based on PCA and Brunet’s Cophenetic Correlation Coefficient achieved the highest accuracy. When evaluated on a well-known real dataset, normalization had an unpredictable effect on the estimate. For any given normalization method, the methods for estimating k gave widely varying results. We conclude that when estimating k, it is best not to apply normalization. If the underlying components are known to be orthogonal, then Velicer’s MAP or Minka’s Laplace-PCA method might be best. However, when the orthogonality of the underlying components is unknown, none of the methods seemed preferable.

Originalsprog Engelsk
Artikelnummer 2840
Tidsskrift Mathematics
Vol/bind 9
Udgave nummer 22
DOI
Status Udgivet - 1 nov. 2021

Bibliografisk note

Funding Information:
Funding: This research was funded by several sources. The work of K.D. was supported in part by NIH Grant P30 CA06927 and an appropriation from the Commonwealth of Pennsylvania. Work of A.D. was supported in part by NIH grants U10NS086513 and K12HD093427.

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

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