Published in 2021

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).

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 tidsskriftReviewForskningpeer 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

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
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.

BACKGROUND: The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated.

METHODS: The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful).

RESULTS: Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3-100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects.

CONCLUSIONS: Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed.

TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

Originalsprog Engelsk
Artikelnummer 122
Tidsskrift Pilot and Feasibility Studies
Vol/bind 7
Udgave nummer 1
Sider (fra-til) 122
ISSN 2055-5784
DOI
Status Udgivet - 11 jun. 2021

Older age, smoking, tooth loss and denture-wearing but neither xerostomia nor salivary gland hypofunction are associated with low intakes of fruit and vegetables in older Danish adults

Pedersen, A. M. L., Dynesen, A. W. & Heitmann, B. L., 17 jul. 2021, I: Journal of Nutritional Science. 10, s. e47

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Xerostomia and salivary gland hypofunction are prevalent conditions in older people and may adversely influence the intake of certain foods, notably fruit and vegetables. Here, we aimed to investigate whether xerostomia and salivary gland hypofunction were associated with a lower intake of fruit and vegetables. The study included 621 community-dwelling adults, mean age 75⋅2 ± 6⋅4 years, 58⋅9 % female, who had participated in the Copenhagen City Heart Study follow-up, and undergone interviews regarding food intake (preceding month), oral and general health (xerostomia, taste alterations, diseases, medication, alcohol consumption and smoking), clinical oral examination and measurements of unstimulated and chewing-stimulated whole saliva flow rates. The average total energy intake (8⋅4 ± 2⋅7 MJ) and protein energy percentage (14⋅8 ± 3⋅1 %) were slightly below recommendations. The average fruit (234⋅7 ± 201⋅2 g/d) and vegetables (317⋅3 ± 157⋅4 g/d) intakes were within recommendations. Xerostomia and hyposalivation were more prevalent in women than in men (16⋅4 v. 7⋅1 %, P < 0⋅001 and 40⋅7 v. 27⋅5 %, P < 0⋅001). Multiple linear regression analyses revealed that older age (β -0⋅009, se 0⋅003, P = 0⋅005), smoking (β -0⋅212, se 0⋅060, P = 0⋅0005) and wearing complete dentures/being partially or fully edentulous (β -0⋅141, se 0⋅048, P = 0⋅003), but neither xerostomia nor salivary flow rates were associated with an inadequate fruit and vegetable intake, after adjustment for covariates. Older age, smoking, tooth loss and denture-wearing were stronger determinants of low fruit and vegetable intakes than xerostomia and salivary hypofunction supporting the importance of dietary counselling and maintenance of oral health and an adequate masticatory performance.

Originalsprog Engelsk
Tidsskrift Journal of Nutritional Science
Vol/bind 10
Sider (fra-til) e47
ISSN 0029-6651
DOI
Status Udgivet - 17 jul. 2021

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Nielsen, S. M., Boers, M., de Wit, M., Shea, B., van der Windt, D. A., Reeves, B. C., Beaton, D., Alten, R., Toupin April, K., Boonen, A., Escorpizo, R., Flurey, C., Furst, D. E., Guillemin, F., Leong, A., Pohl, C., Rasmussen, M. U., Singh, J. A., Smolen, J. S., Strand, V., Verstappen, S. M. M., Voshaar, M., Woodworth, T. G., Ellingsen, T., March, L., Wells, G. A., Tugwell, P. & Christensen, R., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 601-606 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To develop an operational definition of contextual factors (CF) [1].

METHODS: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

RESULTS: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

CONCLUSION: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 601-606
Antal sider 6
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

INTRODUCTION: The effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.

RESEARCH DESIGN AND METHODS: We performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, 'U-TURN'), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).

RESULTS: We included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI -0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI -4.6 to -0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).

CONCLUSION: In persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.

TRIAL REGISTRATION NUMBER: NCT02417012.

Originalsprog Engelsk
Artikelnummer e001840
Tidsskrift BMJ open diabetes research & care
Vol/bind 9
Udgave nummer 1
ISSN 2052-4897
DOI
Status Udgivet - jan. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

One-year treatment outcomes of secukinumab versus tumor necrosis factor inhibitors in Spondyloarthritis

Glintborg, B., Lindstrom, U., De Giuseppe, D., Provan, S. A., Gudbjornsson, B., Hetland, M. L., Michelsen, B., Wallman, J., Aaltonen, K., Hokkanen, A-M., Nordström, D., Jørgensen, T. S., Hansen, R. L., Jon Geirsson, A., Grøn, K., Krogh, N. S., Askling, J., Kristensen, L. E., Jacobsson, L. & DANBIO (Denmark), ARTIS/SRQ (Sweden), ICEBIO (Iceland), ROB-FIN (Finland), NOR-DMARD (Norway) registries, 2021, (E-pub ahead of print) I: Arthritis Care & Research.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To describe baseline characteristics and to compare treatment effectiveness of secukinumab versus tumor necrosis factor inhibitors (TNFi), in patients with spondyloarthritis (SpA) using adalimumab as the main comparator.

METHODS: Observational, prospective cohort study. Patients with SpA (clinical ankylosing spondylitis/non-radiographic axial SpA/undifferentiated SpA) starting secukinumab or a TNFi during 2015-2018 were identified from five Nordic clinical rheumatology registries. Comorbidities and extra-articular manifestations (psoriasis/uveitis/inflammatory bowel disease) were captured from national registries (data available in 94% of patients) and included in multivariable analyses. We assessed 1-year treatment retention (crude survival curves, adjusted hazard ratios (HR) for treatment discontinuation) and 6-months' response-rates (ASDAS<2.1/BASDAI<40mm, crude/LUNDEX-adjusted, adjusted logistic-regression analyses with odds-ratio(OR)), stratified by line of biological treatment (1st /2nd /3rd +).

RESULTS: In total, 10,853 treatment courses (842 secukinumab/10,011 TNFi whereof 1,977 adalimumab) were included. The proportion treated with secukinumab during 1st /2nd /3rd + was 1%/6%/22%). Extra-articular manifestations varied across treatments, while other baseline characteristics were largely similar. Secukinumab had a one-year retention comparable to adalimumab as 1st or 2nd , but poorer as 3rd + line of therapy (secukinumab 56% (51%-61%) versus adalimumab 70% (64%-75%)), adjusted HR 1.43 (1.12-1.81). Across treatment lines, secukinumab had poorer estimates for 6-months response rates than adalimumab, statistically significantly so only for 3rd + line (adjusted analyses: ASDAS<2.1 OR=0.56 (0.35-0.90), BASDAI<40mm OR=0.62 (0.41-0.95)). Treatment outcomes varied across the five TNFi.

CONCLUSION: Secukinumab was mainly used in biologically experienced SpA patients. Secukinumab and adalimumab performed similar in patients who had failed a first biological, although with increasing prior biological exposure, adalimumab was superior.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
ISSN 2151-464X
DOI
Status E-pub ahead of print - 2021

Bibliografisk note

COPECARE

Outcome domains reported by patients, caregivers, healthcare professionals and stakeholders for calcium pyrophosphate deposition (CPPD): A content analysis based on semi-structured qualitative interviews from the OMERACT CPPD working group

Fuller, A., Cai, K., Diaz-Torne, C., Filippou, G., Pascart, T., Hensey, O., Grossberg, D., Christensen, R., Shea, B., Singh, J. A., Tedeschi, S. K., Dalbeth, N. & Abhishek, A., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 650-654 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Although calcium pyrophosphate deposition (CPPD) disease is common, there are no validated outcome measures for clinical research in this condition. The aim of this study was to generate a list of outcome domains as reported by patients, their caregivers, healthcare professionals (HCPs) and stakeholders to inform the development of an Outcome Measures in Rheumatology (OMERACT) Core Domain Set for CPPD.

METHODS: Patients with CPPD and their caregivers, HCPs and stakeholders took part in semi-structured qualitative interviews to explore potential outcome domains for CPPD clinical research relevant to their lived experience and knowledge of CPPD. Interviews were conducted in six countries across three continents. Data was analysed using manifest content analysis to identify outcome domains, which were tabulated and mapped to the core areas as defined by the OMERACT Filter 2.1.

RESULTS: Thirty-six interviews were conducted in total. Participants comprised of 28 patients (six of which included a caregiver), seven HCPs and one stakeholder. The commonly identified (sub-) domains (d) across the 1) abnormalities/manifestations core area were joint pain (d = 35), joint swelling (d = 27), joint stiffness (d = 25), CPPD flares (d = 25); 2) life-impact core area were overall function (d=35), and specifically the ability to complete daily tasks (d = 25); and 3) societal/resource use core area were use of analgesic medicines (d = 26). Patients more commonly reported joint swelling, stiffness and range of movement, and use of analgesics while HCPs more commonly reported domains relating to presence of CPP crystals, radiologic calcification, joint damage, time to diagnosis and suitability of treatment.

CONCLUSION: Among a number of potential outcome domains identified, articular manifestations, function and analgesic use were most frequently mentioned by participants. These findings will be used to develop an OMERACT Core Domain Set for CPPD.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 650-654
Antal sider 5
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

Outcomes Reported in Prospective Long-Term Observational Studies and Registries of Patients With Rheumatoid Arthritis Worldwide: An Outcome Measures in Rheumatology Systematic Review

Lopez-Olivo, M. A., Zogala, R. J., des Bordes, J., Zamora, N. V., Christensen, R., Rai, D., Goel, N., Carmona, L., Pratt, G., Strand, V. & Suarez-Almazor, M. E., maj 2021, I: Arthritis Care & Research. 73, 5, s. 649-657 9 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: Prospective long-term observational studies (LOS) in rheumatoid arthritis (RA) lack a core set of universally collected outcome measures, particularly patient-centered outcomes, precluding accurate comparisons across studies. Our aim was to identify long-term outcome measures collected and reported in these studies.

METHODS: We conducted a systematic review of registries and LOS of patients with RA, searching in ClinicalTrials.gov, the Agency for Healthcare Research and Quality Registry of Patient Registries, and Google Scholar. The names and acronyms of registries and LOS were further searched in the Medline and Embase databases to retrieve published articles. Two independent reviewers undertook data collection, quality appraisal, and data extraction.

RESULTS: We identified 88 registries/LOS that met our eligibility criteria. These were divided into 2 groups: disease-based (52 [59%]) and therapy-based (36 [41%]). Methodologic and reporting standards varied across the eligible studies. For clinical outcomes, disease activity was recorded in 88 (100%) of all LOS/registries. The most commonly reported measure (86 [98%]) was the composite outcome Disease Activity Score using 28 joints. Of the patient-centered outcomes collected, physical functioning was most frequently reported (75 [85%]) with the Health Assessment Questionnaire (75 [85%]) as the most commonly used instrument within this domain. Other domains of patient-centered outcomes were comparatively infrequently recorded: mental (29 [33%]), social (20 [23%]), and health-related quality of life (37 [42%]).

CONCLUSION: Most registries/LOS collect measures of disease activity and physical function. However, there is substantial heterogeneity in the collection of relevant patient-centered outcomes that measure symptom burden and mental and social ramifications of RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 73
Udgave nummer 5
Sider (fra-til) 649-657
Antal sider 9
ISSN 2151-464X
DOI
Status Udgivet - maj 2021

PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

Mollerup, A., Larsen, S. C., Bennetzen, A. S., Henriksen, M., Simonsen, M. K., Weis, N., Kofod, L. M. & Heitmann, B. L., 30 jun. 2021, I: BMJ Open. 11, 6, s. 1-9 9 s., e050582.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Infection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.

METHODS AND ANALYSIS: In this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.

ETHICS AND DISSEMINATION: The study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.

TRIAL REGISTRATION NUMBER: NCT04530435; Pre-results.

Originalsprog Engelsk
Artikelnummer e050582
Tidsskrift BMJ Open
Vol/bind 11
Udgave nummer 6
Sider (fra-til) 1-9
Antal sider 9
ISSN 2044-6055
DOI
Status Udgivet - 30 jun. 2021

Perceived Benefits, Barriers, and Facilitators of a Digital Patient-Reported Outcomes Tool for Routine Diabetes Care: Protocol for a National, Multicenter, Mixed Methods Implementation Study

Skovlund, S. E., Nicolucci, A., Balk-Møller, N., Berthelsen, D. B., Glümer, C., Perrild, H., Kjær, P., Nørgaard, L. M., Troelsen, L. H., Pietraszek, A., Hessler, D., Kaplan, S. & Ejskjær, N., 3 sep. 2021, I: JMIR research protocols. 10, 9, s. e28391 e28391.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: There is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO tools in routine care. Furthermore, limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings.

OBJECTIVE: This study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different health care settings in Denmark and to determine the factors affecting its implementation. Furthermore, the study evaluates the psychometric characteristics of the Danish PRO Diabetes Questionnaire and the validity of the scoring algorithms for dialogue support. The objective of this study is to guide the ongoing optimization of the PRO diabetes tool, its implementation, and the design of future randomized controlled effectiveness studies.

METHODS: We designed a multicenter, mixed methods, single-arm acceptability-feasibility implementation study protocol to contribute to the real-world pilot test of a new digital PRO diabetes tool in routine diabetes care. The use of the tool involves two main steps. First, the people with diabetes will complete a digital PRO Diabetes Questionnaire in the days before a routine diabetes visit. Second, the health care professional (HCP) will use a digital PRO tool to review the PRO results together with the people with diabetes during the visit. The PRO diabetes tool is designed to encourage and support people to take an active role for the people with diabetes in their own care and to expedite the delivery of person-centered, collaborative, and coordinated care.

RESULTS: A multicenter pilot study protocol and psychometrically designed digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention. A total of 598 people with diabetes and 34 HCPs completed the study protocol by April 1, 2021.

CONCLUSIONS: A large-scale, mixed methods, multicenter study for evaluating the use of the nationally developed PRO Diabetes Questionnaire in routine care across all health care sectors in Denmark by using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) model as a framework has been designed and is ongoing. This study is expected to provide new important and detailed information about the real-world acceptability, perceived relevance, and benefits of the PRO diabetes tool among a large heterogeneous population of people with diabetes in Denmark and HCPs in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies, and design future controlled effectiveness studies.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28391.

Originalsprog Engelsk
Artikelnummer e28391
Tidsskrift JMIR research protocols
Vol/bind 10
Udgave nummer 9
Sider (fra-til) e28391
ISSN 1929-0748
DOI
Status Udgivet - 3 sep. 2021

Perioperative Alcohol and Smoking Cessation Intervention: Impact on Other Lifestyles

Merzaai, B., Tonnesen, H., Rasmussen, M. & Lauridsen, S. V., feb. 2021, I: Seminars in Oncology Nursing. 37, 1, s. 151116

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: Cigarette smoking and alcohol drinking are preventable risk factors in surgery. It is unknown whether intervening on these two risk factors also have an effect on other lifestyles. Therefore, the primary aim of this study was to compare the effect of an intensive alcohol and smoking cessation intervention on other lifestyles (malnutrition, obesity, and physical inactivity) with treatment as usual, among patients scheduled for radical cystectomy. The secondary aim was to evaluate associations between successful quitting and changes in other lifestyles.

DATA SOURCES: Data on 94 patients with bladder cancer undergoing radical cystectomy originated from the STOP-OP study, a randomized intervention trial that enrolled patients from four Danish hospitals. Patients were enrolled between November 2014 and July 2017.

CONCLUSION: We found no significant differences regarding the three lifestyle factors; risk of malnutrition, obesity, and physical inactivity between patients in the intervention and standard care at the end of the intervention at 6 weeks, 3 months, 6 months, and 12 months. Also, there were no significant associations between successful quitters and non-quitters for alcohol and smoking and the other three lifestyles; risk of malnutrition, obesity, and physical inactivity.

IMPLICATIONS FOR NURSING PRACTICE: Findings from this study show that cancer surgery is a good opportunity to address lifestyle changes and that more research into the effect of multimodal interventions are needed. Guidelines on how to support patients to change lifestyle in relation to surgery should be part of nursing practice.

Originalsprog Engelsk
Tidsskrift Seminars in Oncology Nursing
Vol/bind 37
Udgave nummer 1
Sider (fra-til) 151116
ISSN 0749-2081
DOI
Status Udgivet - feb. 2021

Phase angle measured by bioelectrical impedance analysis and the risk of cardiovascular disease among adult Danes

Langer, R. D., Larsen, S. C., Ward, L. C. & Heitmann, B. L., sep. 2021, I: Nutrition (Burbank, Los Angeles County, Calif.). 89, s. 111280 111280.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: This study aimed to examine associations between phase angle (PhA) and incident cardiovascular disease (CVD) morbidity and mortality in a healthy Danish subpopulation free of major chronic diseases.

METHODS: A random subset (n = 2601) of adult men and women born in 1922, 1932, 1942, and 1952 and examined in 1987 and 1988 were included, and followed over 24 y during which 643 men and 570 women developed CVD. Measures at baseline included age, weight, height, whole-body bioimpedance, from which PhA was calculated, and information on lifestyle, obtained by a self-administered questionnaire. The association between PhA and incident CVD was assessed by Cox proportional hazard model with age as the underlying time scale and with additional adjustment for covariates. To explore nonlinear associations, all results were presented using restricted cubic splines, with the median value of PhA as the reference.

RESULTS: PhA was lower among women who later developed CVD than among women who did not (6.3 vs. 6.0; P < 0.001). The highest risk of CVD was observed at the 5th percentile (hazard ratio: 1.33; 95% confidence interval, 1.11-1.60). Among men, PhA was not significantly associated with risk of CVD (7.1 vs. 7.0; P = 0.246).

CONCLUSIONS: Among apparently healthy Danish men and women, a lower PhA value was associated with a higher incidence of CVD over 24 y, also after adjusting for potential confounders, and particularly among women. These findings may encourage the future use of PhA as an additional index in predicting CVD. However, more studies are needed to confirm our results.

Originalsprog Engelsk
Artikelnummer 111280
Tidsskrift Nutrition (Burbank, Los Angeles County, Calif.)
Vol/bind 89
Sider (fra-til) 111280
ISSN 0899-9007
DOI
Status Udgivet - sep. 2021

Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects

Hafliðadóttir, S. H., Juhl, C. B., Nielsen, S. M., Henriksen, M., Harris, I. A., Bliddal, H. & Christensen, R., 26 jul. 2021, I: Trials. 22, 1, s. 493 493.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

BACKGROUND: Contextual effects (i.e., placebo response) refer to all health changes resulting from administering an apparently inactive treatment. In a randomized clinical trial (RCT), the overall treatment effect (i.e., the post-treatment effect in the intervention group) can be regarded as the true effect of the intervention plus the impact of contextual effects. This meta-research was conducted to examine the average proportion of the overall treatment effect attributable to contextual effects in RCTs across clinical conditions and treatments and explore whether it varies with trial contextual factors.

METHODS: Data was extracted from trials included in the main meta-analysis from the latest update of the Cochrane review on "Placebo interventions for all clinical conditions" (searched from 1966 to March 2008). Only RCTs reported in English having an experimental intervention group, a placebo comparator group, and a no-treatment control group were eligible.

RESULTS: In total, 186 trials (16,655 patients) were included. On average, 54% (0.54, 95%CI 0.46 to 0.64) of the overall treatment effect was attributable to contextual effects. The contextual effects were higher for trials with blinded outcome assessor and concealed allocation. The contextual effects appeared to increase proportional to the placebo effect, lower mean age, and proportion of females.

CONCLUSION: Approximately half of the overall treatment effect in RCTs seems attributable to contextual effects rather than to the specific effect of treatments. As the study did not include all important contextual factors (e.g., patient-provider interaction), the true proportion of contextual effects could differ from the study's results. However, contextual effects should be considered when assessing treatment effects in clinical practice.

TRIAL REGISTRATION: PROSPERO CRD42019130257 . Registered on April 19, 2019.

Originalsprog Engelsk
Artikelnummer 493
Tidsskrift Trials
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 493
ISSN 1745-6215
DOI
Status Udgivet - 26 jul. 2021

OBJECTIVES: To investigate biomechanical changes in lumbar disc herniations.

METHODS: Patients with lumbar disc herniation verified on a 1.5-3-T magnetic resonance imaging (MRI) scanner were imaged in a weight-bearing 0.25-T MRI scanner in (1) standing position, (2) conventional supine position with relative lumbar flexion, and (3) supine position with a forced lumbar extension by adding a lumbar pillow. The L2-S1 lordosis angle, the disc cross-sectional area, the disc cross-sectional diameter, and the spinal canal cross-sectional diameter were measured for each position. Disc degeneration and nerve root compression were graded, and the pain intensity was reported during each scan position.

RESULTS: Forty-three herniated discs in 37 patients (36.7 ± 11.9 years) were analyzed in each position. The L2-S1 lumbar angle increased in the standing position (mean difference [MD]: 5.61°, 95% confidence interval [95% CI]: 3.44 to 7.78) and with the lumbar pillow in the supine position (MD: 14.63°, 95% CI: 11.71 to 17.57), both compared with the conventional supine position. The herniated disc cross-sectional area and diameter increased during standing compared with during conventional supine position. No changes were found in the spinal canal cross-sectional diameter between positions. Higher nerve root compression grades for paracentral herniations were found during standing compared with during conventional supine position. This was neither found with a lumbar pillow nor for central herniations in any position compared with conventional supine.

CONCLUSION: Disc herniations displayed dynamic behavior with morphological changes in the standing position, leading to higher nerve root compression grades for paracentral herniated discs.

KEY POINTS: • Lumbar herniated discs increased in size in the axial plane during standing. • Increased nerve root compression grades for paracentral herniated discs were found during standing. • Weight-bearing MRI may increase the diagnostic sensitivity of nerve root compression in lumbar disc herniations.

Originalsprog Engelsk
Tidsskrift European Radiology
Vol/bind 31
Udgave nummer 2
Sider (fra-til) 804-812
Antal sider 9
ISSN 0938-7994
DOI
Status Udgivet - feb. 2021

Predictors of joint damage progression and stringent remission in patients with established rheumatoid arthritis in clinical remission

Møller-Bisgaard, S., Georgiadis, S., Hørslev-Petersen, K., Ejbjerg, B., Hetland, M. L., Ørnbjerg, L. M., Glinatsi, D., Møller, J., Boesen, M., Stengaard-Pedersen, K., Madsen, O. R., Jensen, B., Villadsen, J. A., Hauge, E-M., Bennett, P., Hendricks, O., Asmussen, K., Kowalski, M., Lindegaard, H., Bliddal, H., Krogh, N. S., Ellingsen, T., Nielsen, A. H., Balding, L., Jurik, A. G., Thomsen, H. S. & Østergaard, M., jan. 2021, I: Rheumatology (Oxford, England). 60, 1, s. 380-391 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To study if clinical, radiographic and MRI markers can predict MRI and radiographic damage progression and achievement of stringent remission in patients with established RA in clinical remission followed by a targeted treatment strategy.

METHODS: RA patients (DAS28-CRP <3.2, no swollen joints) receiving conventional synthetic DMARDs were randomized to conventional or MRI-targeted treat-to-target strategies with predefined algorithmic treatment escalations. Potentially predictive baseline variables were tested in multivariate logistic regression analyses.

RESULTS: In the 171 patients included, baseline MRI osteitis independently predicted progression in MRI erosion [odds ratio (OR) 1.13 (95% CI 1.06, 1.22)], joint space narrowing [OR 1.15 (95% CI 1.07, 1.24)] and combined damage [OR 1.23 (95% CI 1.13, 1.37)], while tenosynovitis independently predicted MRI erosion progression [OR 1.13 (95% CI 1.03, 1.25)]. A predictor of radiographic erosion progression was age, while gender predicted progression in joint space narrowing. Following an MRI treat-to-target strategy predicted stringent remission across all remission definitions: Clinical Disease Activity Index remission OR 2.94 (95% CI 1.25, 7.52), Simplified Disease Activity Index remission OR 2.50 (95% CI 1.01, 6.66), ACR/EULAR Boolean remission OR 5.47 (95% CI 2.33, 14.13). Similarly, low tender joint count and low patient visual analogue scale pain and global independently predicted achievement of more stringent remission.

CONCLUSION: Baseline MRI osteitis and tenosynovitis were independent predictors of 2 year MRI damage progression in RA patients in clinical remission, while independent predictors of radiographic damage progression were age and gender. Following an MRI treat-to-target strategy, low scores of patient-reported outcomes and low tender joint count predicted achievement of stringent remission.

TRIAL REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov), NCT01656278.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 1
Sider (fra-til) 380-391
Antal sider 12
ISSN 1462-0324
DOI
Status Udgivet - jan. 2021

Bibliografisk note

COPECARE

Prenatal and Early Life Exposure to the Danish Mandatory Vitamin D Fortification Policy Might Prevent Inflammatory Bowel Disease Later in Life: A Societal Experiment

Duus, K. S., Moos, C., Frederiksen, P., Andersen, V. & Heitmann, B. L., 19 apr. 2021, I: Nutrients. 13, 4, 1367.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

This register-based national cohort study of 206,900 individuals investigated whether prenatal exposure to small extra doses of vitamin D from fortified margarine prevented inflammatory bowel disease (IBD) later in life; whether the risk of IBD varied according to month or season of birth; and finally, whether there was an interaction between exposure to extra D vitamin and month or season of birth. Fortification of margarine with vitamin D was mandatory in Denmark from the mid-1930s until 1st June 1985, when it was abolished. Two entire birth cohorts, each including two years, were defined: one exposed and one unexposed to the fortification policy for the entire gestation. All individuals were followed for 30 years from the day of birth for an IBD diagnosis in Danish hospital registers. Logistic regression analyses were used to estimate odds ratios (OR) and 95% confidence intervals (CI). Odds for IBD was lower among those exposed to extra D vitamin compared to those unexposed, OR = 0.87 (95% CI: 0.79; 0.95). No association with month or season of birth was found. However, estimates suggested that particularly children born during autumn may have benefitted from the effect of small extra doses of vitamin D. This is, to our knowledge, the first study to explore if prenatal exposure to vitamin D from fortification influenced the risk of IBD. Our results suggest that prenatal exposure to small amounts of extra vitamin D from food fortification may protect against the development of IBD before 30 years of age.

Originalsprog Engelsk
Artikelnummer 1367
Tidsskrift Nutrients
Vol/bind 13
Udgave nummer 4
ISSN 2072-6643
DOI
Status Udgivet - 19 apr. 2021

BACKGROUND: A vital public health challenge lies in understanding the primary drivers behind excessive weight gain among healthy weight individuals.

OBJECTIVES: To examine if excessive weight and fat gain can be prevented among healthy weight, obesity susceptible children aged 2 to 6 years.

METHODS: Eligible children were identified based on information on either a high birth weight, maternal pre-pregnancy obesity or maternal low educational level from national registries, and randomized into an intervention group, a control group and a shadow control group. All children with overweight at baseline were excluded from subsequent analysis (n = 196), while healthy weight children were included (n = 926). The intervention was designed to deliver improvements in diet and physical activity habits, optimization of sleep quantity and quality, and reduction of family stress. The average intervention period was 1.3 years.

RESULTS: Intention-to-treat analyses indicated a lower gain in percentage fat mass and a higher gain in fat-free mass in the intervention group compared with the control group. However, the results should be interpreted with caution, as they were clinically small and borderline significant, only.

CONCLUSION: This primary prevention intervention among young healthy weight children with susceptibility to future obesity had clinically small effects on growth and body composition. More interventions, conducting primary obesity prevention, are urgently needed.

Originalsprog Engelsk
Artikelnummer e12736
Tidsskrift Pediatric obesity
Vol/bind 16
Udgave nummer 4
Sider (fra-til) e12736
ISSN 1524-6817
DOI
Status Udgivet - apr. 2021

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