Published in 2020

Reduction in Upper Limb Joint Surgery Among Rheumatoid Arthritis Patients: An Interrupted Time-Series Analysis Using Danish Health Care Registers

Cordtz, R., Hawley, S., Prieto-Alhambra, D., Højgaard, P., Zobbe, K., Kristensen, L. E., Overgaard, S., Odgaard, A., Soussi, B. G. & Dreyer, L., feb. 2020, I: Arthritis Care & Research. 72, 2, s. 274-282 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Joint replacement surgery is a proxy of severe joint damage in rheumatoid arthritis (RA). The aim of this study was to assess the impact of the introduction of biologic disease-modifying antirheumatic drugs (bDMARDs) on the incidence rate (IR) of upper limb joint replacements among newly diagnosed RA patients.

METHODS: Using the Danish National Patient Register, patients with incident RA from 1996-2012 were identified. Each patient was matched on age, sex, and municipality, with up to 10 general population controls. The age- and sex-standardized 5-year IR per 1,000 person-years of a composite outcome of any first joint replacement of the finger, wrist, elbow, or shoulder was calculated, and an interrupted time-series analysis was undertaken to investigate trends and changes of the IR in the pre-bDMARD (1996-2001) and the bDMARD eras (2003-2012), with a 1-year lag period in 2002.

RESULTS: In total, 18,654 incident patients with RA were identified (mean age 57.6 years, 70.5% women). The IR of joint replacements among patients with RA was stable at 2.46 per 1,000 person-years (95% confidence interval [95% CI] 1.96, 2.96) from 1996 to 2001 but started to decrease from 2003 onwards (-0.08 per 1,000 person-years annually [95% CI -0.20, 0.02]). Compared with patients with RA, the IR among controls in 1996 was 1/17 and increased continuously throughout the study period.

CONCLUSION: The IR of upper limb joint replacements started to decrease among patients with RA from 2002 onwards, whereas it increased among controls. Our results suggest an association between the introduction of bDMARDs and a lower need of joint replacements among patients with RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 72
Udgave nummer 2
Sider (fra-til) 274-282
Antal sider 9
ISSN 2151-464X
DOI
Status Udgivet - feb. 2020

Bibliografisk note

© 2019, American College of Rheumatology.

OBJECTIVE: Fatigue is one of the most significant symptoms, and an outcome of great importance, in patients with psoriatic arthritis (PsA), but associations between underlying components of fatigue experienced by patients in relation to the disease have been sparsely investigated. The objectives were to describe the degree of fatigue in patients with PsA, and to examine important components associated with fatigue.

METHODS: We performed a cross-sectional survey including patients registered in the Danish nationwide registry DANBIO from December 2013 to June 2014. Principal component analysis (PCA) was used to identify factors associated with fatigue.

RESULTS: A total of 1062 patients with PsA were included in the study. A PCA reduced co-variables into 3 components explaining 63% of fatigue in patients. The first component, contributing to 31% of fatigue, was composed of inflammatory factors including swollen and tender joints, physician's global assessment, elevated C-reactive protein (CRP), and high Pain Detect Questionnaire (PDQ) score. The second component, contributing to 17% of fatigue, consisted of increasing age and long disease duration. The third component, contributing to 15% of fatigue, consisted of high PDQ score, tender joint count, increasing age, and concomitant low CRP, suggestive of a chronic pain component consisting of central pain sensitization or structural joint damage.

CONCLUSION: Fatigue in patients with PsA may be driven by clinical inflammatory factors, disease duration, and chronic pain in the absence of inflammation.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 47
Udgave nummer 4
Sider (fra-til) 548-552
Antal sider 5
ISSN 0315-162X
DOI
Status Udgivet - apr. 2020

PURPOSE: The primary objective was to examine the reliability of the Copenhagen Achilles length measure (CALM) in patients with an Achilles tendon rupture and secondary to examine the reliability of Achilles tendon resting angle (ATRA) and Achilles tendon length measure (ATLM).

METHOD: The study was executed as a cross-sectional study on two different groups: one focused on CALM and the other on ATRA/ATLM. CALM was performed on 56 patients at four timepoints during the first year after injury, whereas ATRA/ATLM were carried out on 28 patients. Intra- and inter-rater reliabilities were determined using the intra-class correlation coefficient (ICC), the standard error of the measurement (SEM), and the minimal detectable change (MDC).

RESULTS: For CALM, all measurements, both for injured and non-injured sides as well as for elongation, indicated excellent relative reliability (ICC ≥ 0.75). During the four timepoints, the inter-rater absolute reliability had an SEM that ranged between 0.3 and 0.8 cm (1-4 SEM%) for injured and non-injured sides and 0.3-0.6 cm (18-29 SEM%) for elongation. On an individual level, the inter-rater absolute reliability had an MDC ranging between 0.8 and 2.2 cm (4-11 MDC%) for injured and non-injured sides and 0.8-1.7 cm (47-81 MDC%) for elongation. In the case of ATRA, relative reliability was excellent (ICC ≥ 0.75), and for ATLM, it was fair to excellent (ICC 0.58-0.79). ATRA presented a lower measurement error than ATLM.

CONCLUSION: Copenhagen Achilles length measure showed excellent relative reliability, but had a significant measurement error at four timepoints the first year following an Achilles tendon rupture.

LEVEL OF EVIDENCE: II.

Originalsprog Engelsk
Tidsskrift Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
Vol/bind 28
Udgave nummer 1
Sider (fra-til) 281-290
Antal sider 10
ISSN 0942-2056
DOI
Status Udgivet - jan. 2020

Objective: The aim was to explore dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) as an early marker of therapeutic response in patients with rheumatoid arthritis (RA) starting treatment with certolizumab pegol (CZP).Method: In 40 RA patients initiating CZP (27 patients) or 2 weeks of placebo (PCB) followed by CZP (13 patients), DCE-MRI of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints was performed at weeks 0, 1, 2, 4, 8, and 16. Using semi-automated software, three methods for drawing volume regions of interest (ROIs) in MCP2-5 and PIP2-5 were applied: 'Standard' (slices: all; joints: MCP2-5 together and PIP2-5 together), 'Detailed' (slices: slices with high-quality visualization; joints: as Standard), and 'Single-joint' (slices: as Detailed; joints: each joint separately). The number of enhancing voxels (Nvoxel), initial rate of enhancement (IRE), and maximum enhancement (ME) were extracted and analysed for each method.Results: Nvoxel in MCP2-5, and IRE and ME in PIP2-5 decreased statistically significantly (Wilcoxon rank-sum test, p < 0.02-0.03) after 16 weeks of treatment for the Standard method. Nvoxel and ME decreased significantly more in the CZP group than in the PCB group after 1 week of treatment, but not at later time-points. There were no significant changes for DCE-MRI parameters for the Detailed and Single-joint methods.Conclusions: Certain DCE-MRI parameters detected decreased inflammation during CZP treatment in RA patients. Using specific criteria for ROIs, as in the Detailed and Single-joint methods, decreased the statistical power and could not show any changes over time.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Rheumatology
Vol/bind 49
Udgave nummer 2
Sider (fra-til) 105-111
Antal sider 7
ISSN 0300-9742
DOI
Status Udgivet - mar. 2020

Scope of Outcomes in Trials and Observational Studies of Interventions Targeting Medication Adherence in Rheumatic Conditions: A Systematic Review

Kelly, A., Crimston-Smith, L., Tong, A., Bartlett, S. J., Bekker, C. L., Christensen, R., De Vera, M. A., de Wit, M., Evans, V., Gill, M., March, L., Manera, K., Nieuwlaat, R., Salmasi, S., Scholte-Voshaar, M., Singh, J. A., Sumpton, D., Toupin-April, K., Tugwell, P., van den Bemt, B., Verstappen, S. & Tymms, K., 1 okt. 2020, I: Journal of Rheumatology. 47, 10, s. 1565-1574 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence.

METHODS: We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols.

RESULTS: Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%).

CONCLUSION: The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 47
Udgave nummer 10
Sider (fra-til) 1565-1574
Antal sider 10
ISSN 0315-162X
DOI
Status Udgivet - 1 okt. 2020

Shift work and incidence of dementia: A Danish Nurse Cohort study

Jørgensen, J. T., Hansen, J., Westendorp, R. G. J., Nabe-Nielsen, K., Stayner, L. T., Simonsen, M. K. & Andersen, Z. J., sep. 2020, I: Alzheimer's & dementia : the journal of the Alzheimer's Association. 16, 9, s. 1268-1279 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: A few studies suggest that working night and rotating shifts increase the risk of dementia. We examined the association between shift work and the incidence of dementia in a cohort of female Danish nurses.

METHODS: We linked Danish Nurse Cohort participants, who reported work schedules (day, evening, night, rotating shifts) in 1993 and/or 1999 and their duration in 2009, to Danish registers to obtain information on dementia hospitalizations and prescription medication until November 2018.

RESULTS: Among 6048 nurses who reported work schedules in 1993 and 1999, nurses working night shifts ≥6 years had higher dementia incidence (hazard ratio: 2.43, 95% confidence interval: 1.39 to 4.23) than those working day shifts ≥6 years. Among 8059 nurses who reported shift work duration, nurses working night shifts ≥6 years had higher dementia incidence than those working night shifts <1 year (1.47, 1.06 to 2.06).

DISCUSSION: Persistent night shift work may increase the risk of dementia.

Originalsprog Engelsk
Tidsskrift Alzheimer's & dementia : the journal of the Alzheimer's Association
Vol/bind 16
Udgave nummer 9
Sider (fra-til) 1268-1279
Antal sider 12
ISSN 1552-5260
DOI
Status Udgivet - sep. 2020

Bibliografisk note

© 2020 the Alzheimer's Association.

PURPOSE: To explore smoking cessation between cancer survivors and cancer-free women, and the potential survival benefits from smoking cessation in cancer surviving women.

METHOD: We pooled 46,334 responses from the Danish Nurse Cohort. The cohort consists of female nurses, who were invited for surveys in 1993, 1999 and 2009. Participants were linked to nationwide registries on hospitalization, cause of death and migration through 2016. Odds for smoking cessation by cancer diagnosis were computed in propensity score matched logistic regression models, while survival by postdiagnosis smoking cessation was estimated in cox proportional hazards models.

RESULTS: Eligible for analysis were 7841 women (mean age = 56.7 years, SD ± 7.2), who were smokers at baseline and survived to the next follow-up survey. Of these, 545 women were diagnosed with cancer and matched by propensity score (1:2) with 1090 cancer-free women. Odds for smoking cessation were significantly higher in cancer-diagnosed women compared to their cancer-free peers (OR = 1.31, 95% CI: 1.06-1.61). Moreover, mortality risk was significantly lower among cancer survivors who stopped smoking (HR = 0.64, 95% CI: 0.46-0.91), compared to persistent smokers.

CONCLUSIONS: The results suggest considerable survival benefits from smoking cessation in cancer surviving female nurses, and that the time surrounding cancer diagnosis may serve as a teachable moment for smoking cessation. However, due to substantial methodological limitations embedded in the study, careful interpretation of the presented results is warranted. Future studies are needed to demonstrate the effects of diagnosis on smoking cessation as well as the effects of smoking cessation on survival in female cancer populations.

Originalsprog Engelsk
Tidsskrift European journal of oncology nursing : the official journal of European Oncology Nursing Society
Vol/bind 47
Sider (fra-til) 101796
ISSN 1462-3889
DOI
Status Udgivet - aug. 2020

Bibliografisk note

Copyright © 2020 Elsevier Ltd. All rights reserved.

Sports Imaging of Team Handball Injuries

Fritz, B., Parkar, A. P., Cerezal, L., Storgaard, M., Boesen, M., Åström, G. & Fritz, J., jun. 2020, I: Seminars in Musculoskeletal Radiology. 24, 3, s. 227-245 19 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Team handball is a fast high-scoring indoor contact sport with > 20 million registered players who are organized in > 150 federations worldwide. The combination of complex and unique biomechanics of handball throwing, permitted body tackles and blocks, and illegal fouls contribute to team handball ranging among the four athletic sports that carry the highest risks of injury. The categories include a broad range of acute and overuse injuries that most commonly occur in the shoulder, knee, and ankle. In concert with sports medicine, physicians, surgeons, physical therapists, and radiologists consult in the care of handball players through the appropriate use and expert interpretations of radiography, ultrasonography, CT, and MRI studies to facilitate diagnosis, characterization, and healing of a broad spectrum of acute, complex, concomitant, chronic, and overuse injuries. This article is based on published data and the author team's cumulative experience in playing and caring for handball players in Denmark, Sweden, Norway, Germany, Switzerland, and Spain. The article reviews and illustrates the spectrum of common handball injuries and highlights the contributions of sports imaging for diagnosis and management.

Originalsprog Engelsk
Tidsskrift Seminars in Musculoskeletal Radiology
Vol/bind 24
Udgave nummer 3
Sider (fra-til) 227-245
Antal sider 19
ISSN 1089-7860
DOI
Status Udgivet - jun. 2020

Bibliografisk note

Thieme. All rights reserved.

Patients with chronic schizophrenia often display enlarged striatal volumes, and antipsychotic drugs may contribute via the dopamine D2/3 receptor (D2/3R) blockade. Separating the effects of disease from medication is challenging due to the lack of a proper placebo-group. To address this, we conducted a longitudinal study of antipsychotic-naïve, first-episode schizophrenia patients to test the hypothesis that selective blockade of D2/3R would induce a dose-dependent striatal volume increase. Twenty-one patients underwent structural magnetic resonance imaging (sMRI), single-photon emission computed tomography (SPECT), and symptom severity ratings before and after six weeks of amisulpride treatment. Twenty-three matched healthy controls underwent sMRI and baseline SPECT. Data were analyzed using repeated measures and multiple regression analyses. Correlations between symptom severity decrease, volume changes, dose and receptor occupancy were explored. Striatal volumes did not differ between patients and controls at baseline or follow-up, but a significant group-by-time interaction was found (p = 0.01). This interaction was explained by a significant striatal volume increase of 2.1% in patients (Cohens d = 0.45). Striatal increase was predicted by amisulpride dose, but not by either D2/3R occupancy or baseline symptom severity. A significant reduction in symptom severity was observed at a mean dose of 233.3 (SD = 109.9) mg, corresponding to D2/3R occupancy of 44.65%. Reduction in positive symptoms correlated significantly with striatal volume increase, driven by reductions in hallucinations. Our data demonstrate a clear link between antipsychotic treatment and striatal volume increase in antipsychotic-naïve schizophrenia patients. Moreover, the treatment-induced striatal volume increase appears clinically relevant by correlating to reductions in core symptoms of schizophrenia.

Originalsprog Engelsk
Tidsskrift Frontiers in Neuroscience
Vol/bind 14
Sider (fra-til) 484
ISSN 1662-4548
DOI
Status Udgivet - 2020

Bibliografisk note

Copyright © 2020 Andersen, Raghava, Svarer, Wulff, Johansen, Antonsen, Nielsen, Rostrup, Vernon, Jensen, Pinborg, Glenthøj and Ebdrup.

Substitution of sugar-sweetened beverages for other beverages and the risk of developing coronary heart disease: Results from the Harvard Pooling Project of Diet and Coronary Disease

Keller, A., O'Reilly, E. J., Malik, V., Buring, J. E., Andersen, I., Steffen, L., Robien, K., Männistö, S., Rimm, E. B., Willett, W. & Heitmann, B. L., feb. 2020, I: Preventive Medicine. 131, s. 105970

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Sugar-sweetened beverage (SSB) intake is associated with metabolic disorders. The reduction of SSB intake has been promoted to prevent death and disability from chronic diseases. We investigated the association between SSB intake and the risk of coronary events and death, and assessed if substitution of coffee, tea, milk, fruit juice and artificially-sweetened beverages (ASB) for SSBs was associated with a reduced risk of coronary events and death. This was a follow-up study in which data from six studies were pooled and standard observational analyses were performed. Diet intake was assessed at baseline by food-frequency questionnaires. Hazard ratios (HRs) with 95% confidence intervals for the incidence of coronary events and deaths were calculated by Cox proportional hazards regression. The effect of substituting another beverage for SSBs was calculated by taking the difference in the individual effect estimates. During the median 8.2-year follow-up, 4248 coronary events and 1630 coronary deaths were documented among 284,345 individuals. 355 ml daily increase of SSB intake was associated with an increased risk of coronary events (HR: 1.08; 95%CI: 1.02, 1.14) and possibly coronary death (HR: 1.05; 95%CI: 0.96, 1.16). Substitution analyses suggested that replacing SSBs with coffee (HR: 0.93; 95%CI: 0.87, 1.00) or ASB (HR: 0.89; 95%CI: 0.83, 0.97), might be associated with a lower risk of developing coronary events. We found that SSB intake was associated with an increased risk of coronary events and possibly coronary death. Our findings also suggest that replacing SSB's with ASBs or coffee may lower the risk of developing CHD.

Originalsprog Engelsk
Tidsskrift Preventive Medicine
Vol/bind 131
Sider (fra-til) 105970
ISSN 0091-7435
DOI
Status Udgivet - feb. 2020

Bibliografisk note

Copyright © 2019 Elsevier Inc. All rights reserved.

OBJECTIVE: To evaluate the 18-month postintervention efficacy following a 4-month individually tailored behavioral intervention on daily sitting time in patients with rheumatoid arthritis (RA).

METHODS: In an observer-blinded randomized trial, 150 RA patients were included. During 4 months, the intervention group (n = 75) received 3 motivational counseling sessions and tailored text messages aimed at increasing light-intensity physical activity through reduction of sedentary behavior. The control group (n = 75) maintained their usual lifestyle. The primary outcome was change from baseline to 18 months postintervention in objectively measured daily sitting time (using ActivPAL). Secondary outcomes included changes in clinical patient-reported outcomes and cardiometabolic biomarkers. A mixed-effect repeated measures analysis of covariance model in the intent-to-treat population was applied.

RESULTS: At 22 months follow-up from baseline, 12 participants were lost to follow-up. Compared to baseline, sitting time in the intervention group decreased 1.10 hours/day, whereas it increased by 1.32 hours/day in the control group, a between-group difference of -2.43 hours/day (95% confidence interval [95% CI] -2.99, -1.86; P < 0.0001) favoring the intervention group. For most secondary outcomes, between-group differences favored the intervention: visual analog scale (VAS) pain -15.51 mm (95% CI -23.42, -7.60), VAS fatigue -12.30 mm (95% CI -20.71, -3.88), physical function -0.39 Health Assessment Questionnaire units (95% CI -0.53, -0.26), total cholesterol -0.86 mmoles/liter (95% CI -1.03, -0.68), triglycerides -0.26 mmoles/liter (95% CI -0.43, -0.09), and average glucose -1.15 mmoles/liter (95% CI -1.39, -0.91).

CONCLUSION: The 4-month postintervention results showed that patients in the intervention reduced their daily sitting time and improved patient-reported outcomes and total cholesterol levels compared to the control group. Eighteen months after intervention, patients in the intervention group were still significantly less sedentary than controls. Findings suggest that a behavioral approach is beneficial for promoting long-term physical activity and health in patients with RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 72
Udgave nummer 11
Sider (fra-til) 1560-1570
Antal sider 11
ISSN 2151-464X
DOI
Status Udgivet - nov. 2020

OBJECTIVE: To evaluate the 18-month post-intervention efficacy following a four-month individually tailored, behavioral intervention on daily sitting time in patients with rheumatoid arthritis (RA). The four-month post-intervention results showed that patients in the intervention reduced their daily sitting time, improved patient-reported outcomes and total cholesterol levels compared to the control group.

METHODS: In an observer-blinded randomized trial, 150 RA patients were included. During four months, the intervention group (n=75) received three motivational counselling sessions and tailored text messages aimed at increasing light-intensity physical activity through reduction of sedentary behavior. The control group (n=75) maintained usual lifestyle. Primary outcome was change from baseline to 18 months post intervention in objectively measured daily sitting time (ActivPAL). Secondary outcomes included changes in clinical patient-reported outcomes and cardio-metabolic biomarkers. A mixed effect repeated measures ANCOVA model in the intention-to-treat population was applied.

RESULTS: At 22-months follow-up from baseline, 12 participants were lost to follow-up. Compared to baseline, sitting time in the intervention group decreased 1.10 h/day, whereas it increased by 1.32 h/day in the control group; between-group difference of -2.43 h/day (95%CI: -2.99;-1.86; p<0.0001) favoring the intervention group. For most secondary outcomes between-group differences favored the intervention: VAS-pain: -15.51 mm (-23.42;-7.60), VAS-fatigue: -12.30 mm (-20.71;-3.88), physical function: -0.39 HAQ-units (-0.53;-0.26), total cholesterol: -0.86 (-1.03;-0.68), triglyceride: -0.26 (-0.43;-0.09) and average glucose: -1.15 (-1.39;-0.91) mmol/l.

CONCLUSION: Eighteen months after intervention, patients in the intervention group were still significantly less sedentary than controls. Findings suggest that a behavioral approach is beneficial for promoting long-term physical activity and health in patients with RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 72
Udgave nummer 11
Sider (fra-til) 1560-1570
ISSN 2151-464X
DOI
Status Udgivet - 2020

Bibliografisk note

© 2019, American College of Rheumatology.

The Copenhagen Primary Care Laboratory Pregnancy (CopPreg) database

Janbek, J., Kriegbaum, M., Grand, M. K., Specht, I. O., Lind, B. S., Andersen, C. L. & Heitmann, B. L., 24 maj 2020, I: BMJ Open. 10, 5, s. e034318 e034318.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: The Copenhagen Primary Care Laboratory Pregnancy (CopPreg) database was established based on data from The Danish Medical Birth Register and the Copenhagen Primary Care Laboratory (CopLab) database. The aim was to provide a biomedical and epidemiological data resource for research in early disease programming (eg, parental clinical biomarker levels and pregnancy/ birth outcomes or long-term health in the offspring).

PARTICIPANTS: The cohort consisted in total of 203 608 women (with 340 891 pregnancies) who gave birth to 348 248 children and with 200 590 related fathers. In this paper, we focused on women and fathers who had clinical test requisitions prior to and during pregnancy, and on all children. Thus, the cohort in focus consisted of 203 054 pregnancies with requisitions on 147 045 pregnant women, 39 815 fathers with requisitions during periconception and 65 315 children with requisitions.

FINDINGS TO DATE: In addition to information on pregnancy and birth health status and general socio-demographic data, over 2.2 million clinically relevant test results were available for pregnancies with requisitions, over 1.5 million for children and over 600 000 test results were available for the fathers with requisitions during periconception. These were ordered by general practitioners in the primary care setting only and included general blood tests, nutritional biomarkers (macronutrients and micronutrients) and hormone tests. Information on tests related to infections, allergies, heart and lung function and sperm analyses (fathers) were also available.

FUTURE PLANS: The CopPreg database provides ready to use and valid data from already collected, objectively measured and analysed clinical tests. With several research projects planned, we further invite national and international researchers to use this vast data resource. In a coming paper, we will explore and discuss the indication bias in our cohort.

Originalsprog Engelsk
Artikelnummer e034318
Tidsskrift BMJ Open
Vol/bind 10
Udgave nummer 5
Sider (fra-til) e034318
ISSN 2044-6055
DOI
Status Udgivet - 24 maj 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.

BACKGROUND: Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life.

METHODS: The study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient's self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery.

DISCUSSION: We hypothesize that, compared with the "usual care group", GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient's self-efficacy for exercise and quality of life.

TRIAL REGISTRATION: www.clinicaltrials.gov NCT04103970 , Registered on 24 September 2019.

Originalsprog Engelsk
Artikelnummer 791
Tidsskrift Trials
Vol/bind 21
Udgave nummer 1
ISSN 1745-6215
DOI
Status Udgivet - 15 sep. 2020

OBJECTIVE: To evaluate the structural effects of weight loss on hip or knee osteoarthritis (OA) and to summarize which structural joint pathologies have been examined and the evidence for the outcome measurement instruments applied.

DESIGN: Based on a pre-specified protocol (available: PROSPERO CRD42017065263), we conducted a systematic search of the bibliographic databases, Medline, Embase and Web of Science identifying longitudinal articles reporting the effects of weight loss on structural imaging outcomes in OA of the hip or knee in people who are overweight or obese.

RESULTS: From 1625 potentially eligible records, 14 articles (from 6 cohorts) were included. 2 cohorts were derived from RCTs. Evaluated pathologies were: articular cartilage (n = 7), joint space width (n = 3), bone marrow lesions (n = 5), synovitis (n = 2), effusion (n = 1), meniscus (n = 3), bone marrow density (n = 1) and infrapatellar fat pad (IPFP; n = 2). Cartilage showed conflicting results when evaluating cartilage thickness by direct thickness measurements. Compositional dGEMRIC and T2 mapping measures in early knee OA showed trends towards reduced cartilage degeneration. Joint space width on conventional radiographs showed no change. Weight loss reduced the size of the IPFP. Synovitis and effusion were not affected. Following weight loss DXA showed bone loss at the hip.

CONCLUSION: We did not find consistent evidence of the effects of weight loss on OA structural pathology in people who are overweight or obese. There is a need to achieve consensus on which structural pathologies and measurements to apply in weight loss and OA research.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and Cartilage
Vol/bind 28
Udgave nummer 1
Sider (fra-til) 10-21
Antal sider 12
ISSN 1063-4584
DOI
Status Udgivet - jan. 2020

Bibliografisk note

Copyright © 2019 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

OBJECTIVE: To study the impact of weight loss on inflammation in individuals with overweight and knee osteoarthritis (OA) using both static- and dynamic contrast-enhanced (DCE)-MRI and assess the association of these changes to pain.

DESIGN: Individuals with overweight (BMI > 27) and knee OA were examined before and after a >5% weight loss over 8 weeks (ClinicalTrials.gov NCT02905864). Using 3-T MRI, inflammation was quantified from non-contrast enhanced static-MRI according to MOAKS and contrast enhanced static MRI according to BLOKS and 11-point whole-knee synovitis score. DCE-MRI was used to assess the inflammation in the infra patellar fat pad (IPFP). Pain was assessed using KOOS.

RESULTS: Complete data were available in 117 participants with a mean age of 60 years, BMI of 35 kg/m2 and KOOS pain score of 64. Mean weight loss was 12 kg and KOOS pain was improved by 13 points at follow-up. Change in inflammation was not associated with weight loss in static MRI. None of the MRI variables correlated with the change in KOOS pain.

CONCLUSION: Weight loss did not induce a significant change in inflammation in individuals with overweight and OA. The significant clinical beneficial effect of weight loss on knee pain in individuals with overweight and knee OA seems uncoupled to changes in imaging markers of synovitis.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and Cartilage
Vol/bind 28
Udgave nummer 6
Sider (fra-til) 766-773
Antal sider 8
ISSN 1063-4584
DOI
Status Udgivet - jun. 2020

Bibliografisk note

Copyright © 2020 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

The implications of an aging population and increased obesity for knee arthroplasty rates in Sweden: a register-based study

Overgaard, A., Frederiksen, P., Kristensen, L. E., Robertsson, O. & W-Dahl, A., dec. 2020, I: Acta Orthopaedica . 91, 6, s. 738-742 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background and purpose - Total knee arthroplasty (TKA) has increased substantially in Sweden. We quantified the relative risk for TKA in the Swedish population for different BMI categories and age groups to investigate whether the continued increase in TKA is attributable to increased prevalence of obesity and elderly people in the population, and to put forward model predictions for coming needs for TKA. Patients and methods - We used the Swedish Nationwide Health Survey (SNHS) and the Swedish Knee Arthroplasty Register (SKAR) 2009-2015 to calculate the relative risk (RR) of TKA by age (middle-aged 45-64 years and elderly 65-84 years) and BMI (BMI 18.5-24.9 normal weight; BMI 25.0-29.9 overweight; BMI > 30 obese). The RR for TKA was applied to the demographic forecasts for the Swedish population as a forecasting model. Results - Population size increased 5.2% from 2009 to 2015 to 40,000 middle-aged and 250,000 elderly, and the prevalence of obesity increased from 16% to 18% in these 2 age categories. Compared with those of normal weight, the RR for TKA was 2.7 (95% CI 2.5-3.0) higher for the overweight and 7.3 (6.7-8.0) higher for the obese, aged 45-64. The corresponding figures for individuals aged 65-84 were 2.1 (2.0-2.2) and 4.0 (3.8-4.3) higher, respectively. The changes in the prevalence of obesity and an increase in the elderly population accounted for an estimated increase of 1,700 TKAs over the 7 years. Interpretation - The increase in obesity frequency and the rise in the population of middle-aged and elderly may, to some extent, explain the rise in TKA utilization in Sweden.

Originalsprog Engelsk
Tidsskrift Acta Orthopaedica
Vol/bind 91
Udgave nummer 6
Sider (fra-til) 738-742
Antal sider 5
ISSN 1745-3674
DOI
Status Udgivet - dec. 2020

The Relation between Red Meat and Whole-Grain Intake and the Colonic Mucosal Barrier: A Cross-Sectional Study

Jawhara, M., Sørensen, S. B., Heitmann, B. L., Halldórsson, Þ. I., Pedersen, A. K. & Andersen, V., 12 jun. 2020, I: Nutrients. 12, 6

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The Colonic Mucosal Barrier (CMB) is the site of interaction between the human body and the colonic microbiota. The mucus is the outer part of the CMB and is considered as the front-line defense of the colon. It separates the host epithelial lining from the colonic content, and it has previously been linked to health and diseases. In this study, we assessed the relationship between red meat and whole-grain intake and (1) the thickness of the colonic mucus (2) the expression of the predominant mucin gene in the human colon (MUC2). Patients referred to colonoscopy at the University Hospital of Southern Denmark- Sonderjylland were enrolled between June 2017 and December 2018, and lifestyle data was collected in a cross-sectional study design. Colonic biopsies, blood, urine, and fecal samples were collected. The colonic mucus and bacteria were visualized by immunostaining and fluorescence in situ hybridization techniques. We found a thinner mucus was associated with high red meat intake. Similarly, the results suggested a thinner mucus was associated with high whole-grain intake, albeit to a lesser extent than red meat. This is the first study assessing the association between red meat and whole-grain intake and the colonic mucus in humans. This study is approved by the Danish Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). A study protocol was registered at clinical trials.gov under NCT04235348.

Originalsprog Engelsk
Tidsskrift Nutrients
Vol/bind 12
Udgave nummer 6
ISSN 2072-6643
DOI
Status Udgivet - 12 jun. 2020

The Role of Vitamin D in the Development of Diabetes Post Gestational Diabetes Mellitus: A Systematic Literature Review

Keller, A., Varela Vazquez, C., Dangol, R., Damm, P., Heitmann, B. L. & Händel, M. N., 1 jun. 2020, I: Nutrients. 12, 6, s. 1-17 17 s., 1733.

Publikation: Bidrag til tidsskriftReviewpeer review

Women diagnosed with gestational diabetes mellitus (GDM) are more likely to later develop diabetes. Evidence from some previous reviews suggests that low vitamin D status during pregnancy increases the risk of developing GDM, but whether vitamin D during pregnancy also influences the risk of diabetes post GDM is less well studied. Thus, the aim of this systematic literature review was to summarize the current available literature on that topic. This review considered observational studies and randomized controlled trials (RCTs). Five databases were searched. The risk of bias of the included studies was assessed. A total of six studies were included: three observational studies and three RCTs. Findings were inconsistent across the six included studies. However, when considering RCTs only, the findings more strongly suggested that vitamin D supplementation during and after pregnancy did not have an influence on markers of diabetes development or diabetes development post GDM. This systematic review highlights inconsistent findings on the associations between vitamin D supplementation or concentration during and after pregnancy and markers of diabetes development or diabetes development post GDM; and although results from randomized interventional studies more strongly suggested no associations, the conclusion holds a high degree of uncertainty.

Originalsprog Engelsk
Artikelnummer 1733
Tidsskrift Nutrients
Vol/bind 12
Udgave nummer 6
Sider (fra-til) 1-17
Antal sider 17
ISSN 2072-6643
DOI
Status Udgivet - 1 jun. 2020

Treatment effect sizes vary in randomized trials depending on the type of outcome measure

Berthelsen, D. B., Ginnerup-Nielsen, E., Juhl, C., Lund, H., Henriksen, M., Hróbjartsson, A., Nielsen, S. M., Voshaar, M. & Christensen, R., 23 mar. 2020, I : Journal of Clinical Epidemiology. 123, s. 27-38 12 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: To compare estimated treatment effects of physical therapy (PT) between patient-reported outcome measures (PROMs) and outcomes measured in other ways.

STUDY DESIGN AND SETTING: We selected randomized trials of PT with both a PROM and a non-PROM included in Cochrane systematic reviews (CSRs). Two reviewers independently extracted data and risk-of-bias assessments. Our primary outcome was the ratio of odds ratios (RORs), used to quantify how effect varies between PROMs and non-PROMs; an ROR > 1 indicates larger effect when assessed by using PROMs. We used REML-methods to estimate associations of trial characteristics with effects and between-trial heterogeneity.

RESULTS: From 90 relevant CSRs, 205 PT trials were included. The summary ROR across all the comparisons was not statistically significant (ROR, 0.88 [95% CI: 0.70-1.12]; P = 0.30); however, the heterogeneity was substantial (I2 = 88.1%). When stratifying non-PROMs further into clearly objective non-PROMs (e.g., biomarkers) and other non-PROMs (e.g., aerobic capacity), the PROMs appeared more favorable than did clearly objective non-PROMs (ROR, 1.92 [95% CI: 0.99-3.72]; P = 0.05).

CONCLUSION: Estimated treatment effects based on PROMs are generally comparable with treatment effects measured in other ways. However, in our study, PROMs indicate a more favorable treatment effect compared with treatment effects based on clearly objective outcomes.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 123
Sider (fra-til) 27-38
Antal sider 12
ISSN 0895-4356
DOI
Status E-pub ahead of print - 23 mar. 2020

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

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