Published in 2020

BACKGROUND: We aimed to synthesise qualitative studies exploring medication-related experiences of polypharmacy among patients with multimorbidity.

METHODS: We systematically searched PubMed, Embase and Cumulative Index to Nursing and Allied Health Literature in February 2020 for primary, peer-reviewed qualitative studies about multimorbid patients' medication-related experiences with polypharmacy, defined as the use of four or more medications. Identified studies were appraised for methodological quality by applying the Critical Appraisal Skills Programme checklist for qualitative research, and data were extracted and synthesised by the meta-aggregation approach.

RESULTS: We included 13 qualitative studies, representing 499 patients with polypharmacy and a wide range of chronic conditions. Overall, most Critical Appraisal Skills Programme items were reported in the studies. We extracted 140 findings, synthesised these into 17 categories, and developed five interrelated syntheses: (1) patients with polypharmacy are a heterogeneous group in terms of needing and appraising medication information; (2) patients are aware of the importance of medication adherence, but it is difficult to achieve; (3) decision-making about medications is complex; (4) multiple relational factors affect communication between patients and physicians, and these factors can prevent patients from disclosing important information; and (5) polypharmacy affects patients' lives and self-perception, and challenges with polypharmacy are not limited to practical issues of medication-taking.

DISCUSSION: Polypharmacy poses many challenges to patients, which have a negative impact on quality of life and adherence. Thus, when dealing with polypharmacy patients, it is crucial that healthcare professionals actively solicit individual patients' perspectives on challenges related to polypharmacy. Based on the reported experiences, we recommend that healthcare professionals upscale communicative efforts and involve patients' social network on an individualised basis to facilitate shared decision-making and treatment adherence in multimorbidpatients with polypharmacy.

Originalsprog Engelsk
Tidsskrift BMJ Open
Vol/bind 10
Udgave nummer 9
Sider (fra-til) e036158
ISSN 2044-6055
DOI
Status Udgivet - 6 sep. 2020

Bibliografisk note

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Multi-frequency bioimpedance: a non-invasive tool for muscle-health assessment of adults with cerebral palsy

Pingel, J., Harrison, A., Von Walden, F., Hjalmarsson, E. & Bartels, E. M., sep. 2020, I: Journal of muscle research and cell motility. 41, 2-3, s. 211-219 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Muscle contracture development is a major complication for individuals with cerebral palsy (CP) and has lifelong implications. In order to recognize contracture development early and to follow up on preventive interventions aimed at muscle health development, non-invasive, and easy to use methods are needed. The aim of the present study was to assess whether multi-frequency Bioimpedance (mfBIA) can be used to detect differences between skeletal muscle of individuals with CP and healthy controls. The mfBIA technique was applied to the medial gastrocnemius muscle of n = 24 adults with CP and n = 20 healthy controls of both genders. The phase angle (PA) and the centre frequency (fc) were significantly lower in individuals with CP when compared to controls; PA: - 25% for women and - 31.8% for men (P < 0.0001); fc: - 5.6% for women and - 5.2% for men (P < 0.009). The reactance (Xc) and the extracellular resistance (Re) of skeletal muscle from individuals with CP were significantly higher when compared to controls; Xc: + 9.9% for women and + 28.9% for men (P < 0.0001); Re: + 39.7% for women and + 91.2% for men (P < 0.0001). The present study shows that several mfBIA parameters differ significantly between individuals with CP and healthy controls. Furthermore, these changes correlated significantly with the severity of CP, as assessed using the GMFCS scale. The present data indicate that mfBIA shows promise in terms of being a useful diagnostic tool, capable of characterizing muscle health and its development in individuals with cerebral palsy.

Originalsprog Engelsk
Tidsskrift Journal of muscle research and cell motility
Vol/bind 41
Udgave nummer 2-3
Sider (fra-til) 211-219
Antal sider 9
ISSN 0142-4319
DOI
Status Udgivet - sep. 2020

Muscle function assessed by the non-invasive method acoustic myography (AMG) in a Danish group of healthy adults

Bartels, E. M., Olsen, J. K., Littrup Andersen, E., Danneskiold-Samsøe, B., Bliddal, H., Kristensen, L. E. & Harrison, A. P., 2020, ScienceDirect.

Publikation: AndetUdgivelser på nettet - Net-publikationForskningpeer review

Originalsprog Engelsk
Publikationsdato 2020
Udgiver ScienceDirect
Status Udgivet - 2020

Neonatal vitamin D levels and cognitive ability in young adulthood

Specht, I. O., Janbek, J., Thorsteinsdottir, F., Frederiksen, P. & Heitmann, B. L., aug. 2020, I: European Journal of Nutrition. 59, 5, s. 1919-1928 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: Intelligence has a strong influence on life capability, and thus, identifying early modifiable risk factors related to cognitive ability is of major public health interest. During pregnancy, vitamin D is transported from the mother to the fetus through the placenta in the form of 25-hydroxyvitamin D (25(OH)D). Levels of 25(OH)D have in some studies been associated with childhood neurodevelopment; however, results from all studies are not in agreement. We investigated if neonatal 25(OH)D3 concentrations were associated with Børge Priens IQ test score (BPP) in young adulthood.

METHODS: In this nested cohort study, 25(OH)D3 concentrations were measured in dried blood spots from 818 newborns. We followed the children for their IQ BPP test scores in the Danish Conscription Register, which holds information on test results from the BPP test on individuals who have been recruited for Danish mandatory military draft board examination. Using general linear models, we investigated the crude and adjusted relationship between quintiles of 25(OH)D3 concentrations and BPP IQ test results.

RESULTS: The study population consisted of 95.8% men, with a mean age of 19.4 years. The median and range of the neonatal 25(OH)D3 levels were 26.2 nmol/L (0-104.7 nmol/L). The overall Wald test did not show an association between neonatal 25(OH)D3 levels and BPP IQ scores (p = 0.23); however, individuals within the 3rd (BPP IQ = 101.0, 98.0-103.9) and 4th (BPP IQ = 101.2, 99.1-104.3) quintiles had slightly higher BPP IQ scores than individuals from the first quintile (BPP IQ = 97.6, 94.6-100.6).

CONCLUSIONS: Our results support the hypothesis that individuals with the lowest levels of neonatal vitamin D might have slightly lower BPP. However, more studies are needed with larger study populations to confirm our results.

Originalsprog Engelsk
Tidsskrift European Journal of Nutrition
Vol/bind 59
Udgave nummer 5
Sider (fra-til) 1919-1928
Antal sider 10
ISSN 1436-6207
DOI
Status Udgivet - aug. 2020

Neonatal vitamin D status and myopia in young adult men

Specht, I. O., Jacobsen, N., Frederiksen, P. & Heitmann, B. L., 2020, I: Acta Ophthalmologica. 98, 5, s. 500-505 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: The prevalence of myopia is increasing worldwide, and modifiable risk factors are thus important to identify. Season of birth has been associated with later myopia risk. Neonatal vitamin D status is highly dependent on season of birth due to maternal sun exposure late in gestation. We hypothesize that prenatal exposure to low levels of vitamin D can interfere with visual development in term-born infants and that this might contribute to adult visual dysfunction. The aim of this study was thus to compare neonatal vitamin D levels from stored dried blood spots taken shortly after birth among young term-born men with myopia (cases) and random controls with emmetropia.

METHODS: In this case-control study, we analysed neonatal 25(OH)D3 levels of 457 myopic male cases and 1280 emmetropic male controls assessed for myopia at the mandatory Danish conscript examination. Data were analysed using logistic regression analysis and results presented as crude and adjusted for potential confounders namely maternal age, maternal ethnicity, maternal and paternal education and season of birth.

RESULTS: We did not observe a seasonal variation in myopia risk, neither did we observe increased odds of myopia in relation to low neonatal 25(OH)D3 levels.

CONCLUSION: The rapid increase in myopia does not seem related to neonatal vitamin D status.

Originalsprog Engelsk
Tidsskrift Acta Ophthalmologica
Vol/bind 98
Udgave nummer 5
Sider (fra-til) 500-505
Antal sider 6
ISSN 1755-375X
DOI
Status Udgivet - 2020

Bibliografisk note

© 2020 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Neonatal Vitamin D Status and Risk of Asthma in Childhood: Results from the D-Tect Study

Thorsteinsdottir, F., Cardoso, I., Keller, A., Stougaard, M., Frederiksen, P., Cohen, A. S., Maslova, E., Jacobsen, R., Backer, V. & Heitmann, B. L., 21 mar. 2020, I: Nutrients. 12, 3

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: low vitamin D status in pregnancy can influence the offspring's lung function and contribute to childhood asthma development. The objective of this study was to examine the influence of neonatal vitamin D status on the development of asthma among children age 3-9 years in a large population sample.

METHOD: in a case-cohort study utilizing a Danish biobank and register data we examined the association between neonatal 25-hydroxyvitamin D3 (25(OH)D3) concentrations and incidence of asthma among children aged 3-9 years. Cases of asthma (n = 911) were randomly selected among all cases of asthma in the Danish National Patient Register from children born between 1992 and 2002. The sub-cohort (n = 1423) was randomly selected among all children born in the same period. We used a weighted Cox proportional hazard model assessing the hazard of first asthma diagnoses by quintiles of 25(OH)D3.

RESULTS: the median 25(OH)D3 (interquartile range) for asthma cases was 23 nmol/L (14-35) and the sub-cohort 25 nmol/L (14-40). The hazard ratio for developing asthma between ages 3 and 9 years was lower for children in the fifth quintile of neonatal 25(OH)D3 compared to children in the first quintile, both in the unadjusted (0.61 95% CI: 0.46-0.80) and adjusted (0.55 95% CI: 0.39-0.77) analyses.

CONCLUSION: the results from our study suggest that higher neonatal vitamin D concentration may reduce the risk of developing childhood asthma at ages 3-9 years, indicating that neonatal vitamin D status as a proxy of vitamin D status during the prenatal period is important for normal immune- and lung development.

Originalsprog Engelsk
Tidsskrift Nutrients
Vol/bind 12
Udgave nummer 3
ISSN 2072-6643
DOI
Status Udgivet - 21 mar. 2020

Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial

Eshoj, H. R., Rasmussen, S., Frich, L. H., Hvass, I., Christensen, R., Boyle, E., Jensen, S. L., Søndergaard, J., Søgaard, K. & Juul-Kristensen, B., jan. 2020, I: Orthopaedic Journal of Sports Medicine. 8, 1, s. 2325967119896102

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: There is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs).

Purpose/Hypothesis: The purpose of this study was to assess the efficacy and safety of physical therapist-supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX.

Study Design: Randomized controlled trial; Level of evidence, 2.

Methods: A total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events.

Results: The between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (-228.1 [95% CI, -430.5 to -25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported.

Conclusion: Neuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed.

Registration: NCT02371928 (ClinicalTrials.gov identifier).

Originalsprog Engelsk
Tidsskrift Orthopaedic Journal of Sports Medicine
Vol/bind 8
Udgave nummer 1
Sider (fra-til) 2325967119896102
ISSN 2325-9671
DOI
Status Udgivet - jan. 2020

Bibliografisk note

© The Author(s) 2020.

Novel insights into cerebral palsy

Bartels, E. M., Korbo, L. & Harrison, A. P., 17 feb. 2020, I: Journal of muscle research and cell motility.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. CP affects about 1 in 500 neonates. CP shows clinical features which evolve with age, and these may over time lead to deterioration of motor function although the lesion to the developing brain is non-progressive. The underlying causes for CP remain unclear. Based on recent research we are able to give a physiological explanation on the appearance and development of the condition. The damage to the central nervous system causes a change in collagen structure, with a higher level of deposition of collagen around the muscles, increasing throughout life. Assuming this premise is correct, the question is, will it by any treatment be possible to delay or prevent this collagen accumulation in the CP muscles, thereby giving CP patients a better prognosis in the future.

Originalsprog Engelsk
Tidsskrift Journal of muscle research and cell motility
ISSN 0142-4319
DOI
Status Udgivet - 17 feb. 2020

Nutrients, Diet, and Other Factors in Prenatal Life and Bone Health in Young Adults: A Systematic Review of Longitudinal Studies

Jensen, K. H., Riis, K. R., Abrahamsen, B. & Händel, M. N., 19 sep. 2020, I: Nutrients. 12, 9

Publikation: Bidrag til tidsskriftReviewpeer review

Optimizing skeletal health in early life has potential effects on bone health later in childhood and in adulthood. We aimed to evaluate the existing evidence that maternal exposures during pregnancy have an impact on the subsequent bone health among offspring in young adults aged between 16 and 30 years. The protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO) (ID: CRD42019126890). The search was conducted up to 2 April 2019. We included seven observational prospective cohort studies that examined the association between maternal dietary factors, vitamin D concentration, age, preeclampsia, and smoking with any bone indices among offspring. The results indicated that high concentrations of maternal vitamin D; low fat intake; and high intakes of calcium, phosphorus, and magnesium may increase the bone mineral density in offspring at age 16. Evidence also suggests that the offspring of younger mothers may have a higher peak bone mass. It remains inconclusive whether there is an influence of preeclampsia or maternal smoking on bone health among young adults. Our assessment of internal validity warrants a cautious interpretation of these results, as all of the included studies were judged to have serious risks of bias. High-quality studies assessing whether prenatal prognostic factors are associated with bone health in young adults are needed.

Originalsprog Engelsk
Tidsskrift Nutrients
Vol/bind 12
Udgave nummer 9
ISSN 2072-6643
DOI
Status Udgivet - 19 sep. 2020

Outcome domains reported in calcium pyrophosphate deposition studies: A scoping review by the OMERACT CPPD working group

Cai, K., Fuller, A., Hensey, O., Grossberg, D., Christensen, R., Shea, B., Singh, J. A., Abhishek, A., Tedeschi, S. & Dalbeth, N., aug. 2020, I: Seminars in Arthritis and Rheumatism. 50, 4, s. 719-727 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Although calcium pyrophosphate deposition (CPPD) is common, there are no validated outcome domains and/or measurements for CPPD studies. The aim of this work was to identify domains that have been reported in prior clinical studies in CPPD, to inform the development of a core set of domains for CPPD studies.

METHODS: We performed a scoping literature review for clinical studies in CPPD, searching in Medline (via PubMed), EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases; published from January 1, 1946 to January 7, 2020. All reported outcomes and study design data were extracted and mapped to the core areas and domains as defined by the OMERACT Filter 2.1.The protocol was registered on PROSPERO (CRD: 42019137075; 09-07-2019).

FINDINGS: There were 112 papers identified, comprising of 109 observational studies and three randomized controlled trials. Most studies reported clinical presentations of OA with CPPD or acute CPP crystal arthritis. Outcomes that mapped to 22 domains were identified; the most frequently reported measures mapped to the following domains/sub-domains: imaging (joint damage on imaging tests - 59 studies; joint calcification on imaging tests - 28 studies), joint pain (26 studies), response to treatment (23 studies), side effects of treatment (15 studies), inflammation in the joint fluid or blood (ESR or C-reactive protein - 12 studies; synovial fluid markers - 4 studies; other blood markers - 2 studies), overall function (14 studies), joint swelling (12 studies) and range of joint movement (10 studies). Very few studies mapped to domains related to life impact, societal/resource use or longevity.

CONCLUSION: There is substantial variability in outcomes reported in CPPD studies. Outcomes that map to imaging manifestations, joint pain and response to treatment domains are most often reported.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 50
Udgave nummer 4
Sider (fra-til) 719-727
Antal sider 9
ISSN 0049-0172
DOI
Status Udgivet - aug. 2020

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Pain from torture: assessment and management

Amris, K., Jones, L. E. & Williams, A. C. D. C., 28 jan. 2020, I: Pain Reports . 4, 6, s. e794

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Introduction: Survivors of torture are for many reasons at particularly high risk for inadequate assessment and management of pain. Among the many health problems associated with torture, persistent pain is frequent, particularly pain in the musculoskeletal system. The pathophysiology underlying post-torture pain is largely unknown, but pain inflicted in torture may have profound effects on neurophysiology and pain processing.

Methods: A narrative review of assessment and treatment studies, informed by clinical experience, was undertaken.

Results: The clinical presentation in survivors of torture shares characteristics with other chronic primary pain syndromes, including chronic widespread pain. Unfortunately, such pain is often misunderstood and dismissed as a manifestation of psychological distress, both in specialist psychosocially oriented torture services and in mainstream health care. This means that pain is at risk of not being recognized, assessed, or managed as a problem in its own right.

Conclusions: The available research literature on rehabilitation for torture survivors is predominantly targeted at mental health problems, and studies of effectiveness of pain management in torture survivors are lacking. Rehabilitation is identified as a right in the UN Convention on Torture, aiming to restore as far as possible torture survivors' health and capacity for full participation in society. It is therefore important that pain and its consequences are adequately addressed in rehabilitative efforts. This article summarizes the current status on assessment and management of pain problems in the torture survivor.

Originalsprog Engelsk
Tidsskrift Pain Reports
Vol/bind 4
Udgave nummer 6
Sider (fra-til) e794
ISSN 2471-2531
DOI
Status Udgivet - 28 jan. 2020

Bibliografisk note

Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I)

Skougaard, M., Bliddal, H., Christensen, R., Ellegaard, K., Nielsen, S. M., Zavada, J., Oreska, S., Krogh, N. S., Holm, C. C., Hetland, M. L., Vencovsky, J., Røgind, H., Taylor, P. C. & Gudbergsen, H., 1 maj 2020, I: Journal of Rheumatology. 47, 5, s. 658-667 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: In an eHealth setting, to investigate intra- and interrater reliability and agreement of joint assessments and Disease Activity Score using C-reactive protein (DAS28-CRP) in patients with rheumatoid arthritis (RA) and test the effect of repeated joint assessment training.

METHODS: Patients with DAS28-CRP ≤ 5.1 were included in a prospective cohort study (clinicaltrials.gov: NCT02317939). Intrarater reliability and agreement of patient-performed joint counts were assessed through completion of 5 joint assessments over a 2-month period. All patients received training on joint assessment at baseline; only half of the patients received repeated training. A subset of patients was included in an appraisal of interrater reliability and agreement comparing joint assessments completed by patients, healthcare professionals (HCP), and ultrasonography. Cohen's κ coefficients and intraclass correlation coefficients (ICC) were used for quantifying of reliability of joint assessments and DAS28-CRP. Agreement was assessed using Bland-Altman plots.

RESULTS: Intrarater reliability was excellent with ICC of 0.87 (95% CI 0.83-0.90) and minimal detectable change of 1.13. ICC for interrater reliability ranged between 0.69 and 0.90 (good to excellent). Patients tended to rate DAS28-CRP slightly higher than HCP. In patients receiving repeated training, a mean difference in DAS28-CRP of -0.08 was observed (limits of agreements of -1.06 and 0.90). After 2 months, reliability between patients and HCP was similar between groups receiving single or repeated training.

CONCLUSION: Patient-performed assessments of joints and DAS28-CRP in an eHealth home-monitoring solution were reliable and comparable with HCP. Patients can acquire the necessary skills to conduct a correct joint assessment after initial and thorough training. [clinicaltrials.gov (NCT02317939)].

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 47
Udgave nummer 5
Sider (fra-til) 658-667
Antal sider 10
ISSN 0315-162X
DOI
Status Udgivet - 1 maj 2020

OBJECTIVE: To investigate the association between pain and perfusion in bone marrow lesions with and without cysts assessed dynamic contrast-enhanced (DCE)-MRI in patients with knee osteoarthritis.

SUBJECTS AND METHODS: In a cross-sectional setting, perfusion in bone marrow lesions was assessed using 3 Tesla MRI and correlated (Spearman's rank correlation) to pain using the knee injury and osteoarthritis outcome score (KOOS). Bone marrow lesions were assessed across the whole knee with DCE-MRI using heuristic variable and non-contrast-enhanced-MRI using MRI osteoarthritis knee score.

RESULTS: Data were available from 107 participants. The participants had a mean age of 60.8 years, mean BMI of 34.5 kg/m2, mean KOOS-pain of 63.7 (0-100 scale), and mean bone marrow lesion sum score of 6.5 (0-45 scale). The bivariate association between KOOS-pain and the heuristic perfusion variable time to peak in bone marrow lesions containing subchondral cysts showed a statistically significant correlation (r = 0.40; p = 0.002). The perfusion variables were not correlated with KOOS-pain in bone marrow lesions without cysts.

CONCLUSION: In this cross-sectional study, the rate of perfusion (TTP) in bone marrow lesions containing subchondral cysts was associated with pain in patients with knee OA. DCE-MRI has a potential to be used for separating subtypes of OA.

Originalsprog Engelsk
Tidsskrift Skeletal Radiology
Vol/bind 49
Udgave nummer 5
Sider (fra-til) 757-764
Antal sider 8
ISSN 0364-2348
DOI
Status Udgivet - maj 2020

Population characteristics as important contextual factors in rheumatological trials: an exploratory meta-epidemiological study from an OMERACT Working Group

Nielsen, S. M., Storgaard, H., Ellingsen, T., Shea, B. J., Wells, G. A., Welch, V. A., Furst, D. E., de Wit, M., Voshaar, M., Juhl, C. B., Boers, M., Escorpizo, R., Woodworth, T. G., Boonen, A., Bliddal, H., March, L. M., Tugwell, P. & Christensen, R., okt. 2020, I: Annals of the Rheumatic Diseases. 79, 10, s. 1269-1276 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To explore whether trial population characteristics modify treatment responses across various interventions, comparators and rheumatic conditions.

METHODS: In this meta-epidemiological study, we included trials from systematic reviews available from the Cochrane Musculoskeletal Group published up to 23 April 2019 in Cochrane Library with meta-analyses of five or more randomised controlled trials (RCTs) published from year 2000. From trial reports, we extracted data on 20 population characteristics. For characteristics with sufficient data (ie, available for ≥2/3 of the trials), we performed multilevel meta-epidemiological analyses.

RESULTS: We identified 19 eligible systematic reviews contributing 187 RCTs (212 comparisons). Only age and sex were explicitly reported in ≥2/3 of the trials. Using information about the country of the trials led to sufficient data for five further characteristics, that is, 7 out of 20 (35%) protocolised characteristics were analysed. The meta-regressions showed effect modification by economic status, place of residence, and, nearly, from healthcare system (explaining 4.8%, 0.9% and 1.5% of the between-trial variation, respectively). No effect modification was demonstrated from age, sex, patient education/health literacy or predominant religion.

CONCLUSIONS: This study demonstrates the scarce reporting of most population characteristics, hampering investigation of their impact with meta-research. Our sparse results suggest that place of residence (ie, continent of the trial), economic status (based on World Bank classifications) and healthcare system (based on WHO index for health system performance) may be important in explaining the variation in treatment response across trials. There is an urgent need for consistent reporting of important population characteristics in trials.

PROSPERO REGISTRATION NUMBER: CRD42019127642.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 79
Udgave nummer 10
Sider (fra-til) 1269-1276
Antal sider 8
ISSN 0003-4967
DOI
Status Udgivet - okt. 2020

Bibliografisk note

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Prediction of carotid intima-media thickness and its relation to cardiovascular events in persons with type 2 diabetes

CIMT Trial group, okt. 2020, I: Journal of Diabetes and its Complications. 34, 10, s. 107681 107681.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

AIMS: To investigate measures of carotid intima-media thickness (IMT) and conventional cardiovascular (CV) risk factors as predictors of future carotid IMT, and the prediction of CV events during follow-up based on measures of carotid IMT.

METHODS: Observational longitudinal study including 230 persons with type 2 diabetes (T2D).

RESULTS: Mean age at follow-up was 66.7 (SD 8.5) years, 30.5% were women and mean body mass index (BMI) was 31.8 (4.4) kg/m2. Carotid IMT was measured at baseline, after 18 months of intervention in the Copenhagen Insulin and Metformin Therapy (CIMT) trial and after a mean follow-up of 6.4 (1.0) years. Baseline carotid IMT, carotid IMT after 18 months' intervention, and CV risk factors (age, sex and baseline systolic blood pressure) gave the best prediction of carotid IMT (root mean-squared error of prediction of 0.106 and 95% prediction error probability interval of -0.160, 0.204).

CONCLUSIONS: Measures of carotid IMT combined with CV risk factors at baseline predicts attained carotid IMT better than measures of carotid IMT or CV risk factors alone. Carotid IMT did not predict CV events, and the present results do not support the use of carotid IMT as a predictor of CV events in persons with T2D.

Originalsprog Engelsk
Artikelnummer 107681
Tidsskrift Journal of Diabetes and its Complications
Vol/bind 34
Udgave nummer 10
Sider (fra-til) 107681
ISSN 1056-8727
DOI
Status Udgivet - okt. 2020

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Prenatal exposure to perfluorodecanoic acid is associated with lower circulating concentration of adrenal steroid metabolites during mini puberty in human female infants. The Odense Child Cohort

Jensen, R. C., Glintborg, D., Gade Timmermann, C. A., Nielsen, F., Kyhl, H. B., Frederiksen, H., Andersson, A-M., Juul, A., Sidelmann, J. J., Andersen, H. R., Grandjean, P., Andersen, M. S. & Jensen, T. K., mar. 2020, I: Environmental Research. 182, s. 109101

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Fetal programming of the endocrine system may be affected by exposure to perfluoroalkyl substances (PFAAs), as they easily cross the placental barrier. In vitro studies suggest that PFAAs may disrupt steroidogenesis. "Mini puberty" refers to a transient surge in circulating androgens, androgen precursors, and gonadotropins in infant girls and boys within the first postnatal months. We hypothesize that prenatal PFAA exposure may decrease the concentrations of androgens in mini puberty.

OBJECTIVES: To investigate associations between maternal serum PFAA concentrations in early pregnancy and serum concentrations of androgens, their precursors, and gonadotropins during mini puberty in infancy.

METHODS: In the prospective Odense Child Cohort, maternal pregnancy serum concentrations of five PFAAs: Perfluorohexane sulfonic acid (PFHxS), perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA) were measured at median gestational week 12 (IQR: 10, 15) in 1628 women. Among these, offspring serum concentrations of dehydroepiandrosterone (DHEA), dehydroepiandrosterone-sulfate (DHEAS), androstenedione, 17-hydroxyprogesterone (17-OHP), testosterone, luteinizing (LH) and follicle stimulating hormones (FSH) were measured in 373 children (44% girls; 56% boys) at a mean age of 3.9 (±0.9 SD) months. Multivariate linear regression models were performed to estimate associations.

RESULTS: A two-fold increase in maternal PFDA concentration was associated with a reduction in DHEA concentration by -19.6% (95% CI: -32.9%, -3.8%) in girls. In girls, also, the androstenedione and DHEAS concentrations were decreased, albeit non-significantly (p < 0.11), with a two-fold increase in maternal PFDA concentration. In boys, no significant association was found between PFAAs and concentrations of androgens, their precursors, and gonadotropins during mini puberty.

CONCLUSION: Prenatal PFDA exposure was associated with significantly lower serum DHEA concentrations and possibly also with lower androstenedione and DHEAS concentrations in female infants at mini puberty. The clinical significance of these findings remains to be elucidated.

Originalsprog Engelsk
Tidsskrift Environmental Research
Vol/bind 182
Sider (fra-til) 109101
ISSN 0013-9351
DOI
Status Udgivet - mar. 2020

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Prevalence and risk of occult cancer in stroke

Tybjerg, A. J., Skyhøj Olsen, T. & Andersen, K. K., 2020, I: Acta Neurologica Scandinavica. 141, 3, s. 204-211 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: Cancer is associated with higher risk of stroke. Whether this translates into higher risk of cancer in stroke of an extent calling for cancer screening in stroke is unclear. We investigated prevalence and risk of occult cancer in stroke compared to the background population without history of stroke.

MATERIALS AND METHODS: All patients >40 years of age with incident stroke in Denmark 2003-2015 were identified through the Danish Stroke Registry (n = 85 893) and matched 1:10 on age and sex to the Danish background population without history of stroke (n = 858 740). Linking data to the Danish Cancer Registry, we determined prevalence of occult cancer in stroke defined as the event of previously unknown cancer during a 1-year follow-up in the stroke and in the background population. Cox regression models were used to study risk in comparison to the background population.

RESULTS: Prevalence (per 1000) of occult cancer in the stroke/background cohorts was 25.0/15.8 in women and 29.8/20.4 in men. Prevalence was dependent on age and sex. Highest among stroke patients aged 70-80 years (35.6 in women, 42.4 in men); lowest in patients aged 40-50 years (8.3 in women, 6.8 in men). Stroke was associated with an overall 54% higher risk of occult cancer but risk increased significantly with smoking, hazard ratio (HR) 1.47, age HR 1.27 per 10 years, male sex HR 1.25, and diabetes HR 1.25.

CONCLUSIONS: Prevalence and risk of occult cancer in stroke is considerable and calls for attention when designing the stroke investigation program.

Originalsprog Engelsk
Tidsskrift Acta Neurologica Scandinavica
Vol/bind 141
Udgave nummer 3
Sider (fra-til) 204-211
Antal sider 8
ISSN 0001-6314
DOI
Status Udgivet - 2020

Bibliografisk note

© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The objective was to use accumulated evidence to explore the association between processed meat intake and risk of colorectal cancer (CRC) and to investigate the reliability of associations by evaluating patterns of risk by study population characteristics and research quality parameters. We included 29 observational prospective cohort studies with relative risk estimates and 95% confidence intervals for CRC according to various levels of processed meat consumption. Risk of bias was assessed using Risk Of Bias In Non-randomized Studies-of Interventions (ROBINS-I) tool. Data sources were PubMed and Embase up to January 2017. The summary relative risks for high versus low processed meat consumption and risk of CRC, colon, and rectal cancer were 1.13 (95% CI: 1.01, 1.26), 1.19 (95% CI: 1.09, 1.31), and 1.21 (95% CI: 0.98, 1.49), respectively. Similar estimates were observed for the dose-response analyses. Heterogeneity across studies was detected in most analytical models. The overall judgment showed that two out of 29 studies had a moderate risk of bias, 25 had a serious risk of bias, and 2 had a critical risk of bias. The bias domains most often rated critical were bias due to risk of confounding, bias due to missing data, and selective outcome reporting bias. Although this meta-analysis indicates a modest association between processed meat intake and an increased risk of CRC, our assessment of internal validity warrants a cautious interpretation of these results, as most of the included studies were judged to have serious or critical risks of bias.

Originalsprog Engelsk
Tidsskrift European Journal of Clinical Nutrition
Vol/bind 74
Udgave nummer 8
Sider (fra-til) 1132-1148
Antal sider 17
ISSN 0954-3007
DOI
Status Udgivet - aug. 2020

Carotid intima-media thickness (IMT) can assess the cumulative effect of atherosclerotic risk factors and provides an independent predictor of future cardiovascular (CV) risk. The aim of this study was to investigate the progression of conventional risk factors in 933 long-term survivors from a Danish cohort with and without diabetes mellitus (DM) as predictors for attained carotid IMT during 35.6 (0.7) years of follow-up. Persons who participated in the first, the last and one of the intermediate rounds of the Copenhagen City Heart Study, and who had had an ultrasound-derived measure of the carotid IMT performed at the last examination were included in the analyses. The risk factors varied between persons with and without DM during the 36 years, but the difference in blood pressure disappeared in the fifth examination, where, in addition, total cholesterol was found to be lower in persons with DM. In this cohort there were no difference in attained carotid IMT between persons with and without DM at the last examination. The following risk factors were found to best predict carotid IMT: age, maximum systolic BP, average systolic BP, average BMI, minimum BMI, sex and years of smoking. The prediction of carotid IMT was clinically poor with a root mean-squared error of prediction (RMSEP) of 0.134 mm and a 95% prediction error probability interval of (-0.22; 0.30). Furthermore, the distribution of prediction errors was skewed to the right indicating that the prediction errors were larger among persons with high carotid IMT.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Clinical and Laboratory Investigation
Vol/bind 80
Udgave nummer 6
Sider (fra-til) 491-499
Antal sider 9
ISSN 0036-5513
DOI
Status Udgivet - okt. 2020

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Rodrigues Amorim Adegboye, A., Cocate, P. G., Benaim, C., da Veiga Soares Carvalho, M. C., Schlüssel, M. M., de Castro, M. B. T., Kac, G. & Heitmann, B. L., 5 mar. 2020, I: Trials. 21, 1, s. 244

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy and also to describe the patient-, study protocol- and setting-related factors related to women's ineligibility and refusal to participate in the study.

METHODS: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 × 2 factorial feasibility clinical trial were used. Eighteen women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions, and the data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies.

RESULTS: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (> 20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Non-participation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, patients being unresponsive to phone calls and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthful and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation costs) could hinder participation in the study.

CONCLUSION: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related sociodemographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03148483. Registered on 11 May 2017.

Originalsprog Engelsk
Tidsskrift Trials
Vol/bind 21
Udgave nummer 1
Sider (fra-til) 244
ISSN 1745-6215
DOI
Status Udgivet - 5 mar. 2020

Pages