Published in 2021

Shift work and incidence of psychiatric disorders: The Danish Nurse Cohort study

Jørgensen, J. T., Rozing, M. P., Westendorp, R. G. J., Hansen, J., Stayner, L. T., Simonsen, M. K. & Andersen, Z. J., jul. 2021, I: Journal of Psychiatric Research. 139, s. 132-138 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Research on health effects of shift work has especially focused on somatic diseases, such as breast cancer and cardiometabolic disease, while less attention has been given to the association between shift work and mental health.

METHODS: We used information on 19 964 female nurses (≥44 years) from the Danish Nurse Cohort, who reported current work schedule (day, evening, night, or rotating) at recruitment (1993/1999). In 5102 nurses who participated in both cohort waves, we defined persistent night shift work as working night shift in 1993 and 1999. We used Cox regression models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs), adjusting for relevant confounders. Through linkage of cohort participants to national registers, we defined incidence of mood and neurotic disorders as first hospital contact or redeemed prescription until November 2018.

RESULTS: We found association between night shift work with mood disorders (HR = 1.31; 95%CI = 1.17-1.47) and neurotic disorders (1.29; 1.17-1.42), compared to day work. Associations were enhanced in nurses with persistent night shift work (1.85; 1.43-2.39 and 1.62; 1.26-2.09 for mood and neurotic disorders, respectively) and in nurses with specialist confirmed mood (1.69; 1.24-2.29) and neurotic (1.72; 1.22-2.44) disorders. Nurses with preexisting psychiatric disorders and full-time work seemed most susceptible.

CONCLUSIONS: Night shift work is associated with increased risk of major psychiatric disorders. The novel suggestive findings of vulnerable groups, including nurses with a history of psychiatric disorders and full-time workers, are based on a limited number of cases, and further research is needed to confirm the results.

Originalsprog Engelsk
Tidsskrift Journal of Psychiatric Research
Vol/bind 139
Sider (fra-til) 132-138
Antal sider 7
ISSN 0022-3956
DOI
Status Udgivet - jul. 2021

Similar lipid level changes in early rheumatoid arthritis patients following 1-year treat-to-target strategy with adalimumab plus methotrexate versus placebo plus methotrexate: secondary analyses from the randomised controlled OPERA trial

Mašić, D., Stengaard-Pedersen, K., Løgstrup, B. B., Hørslev-Petersen, K., Hetland, M. L., Junker, P., Østergaard, M., Ammitzbøll, C., Möller, S., Christensen, R. & Ellingsen, T., mar. 2021, I: Rheumatology International. 41, 3, s. 543-549 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

To compare changes in low-density lipoprotein cholesterol and other lipids in patients with rheumatoid arthritis (RA) randomised to a 1-year treat-to-target strategy with either adalimumab plus methotrexate or placebo plus methotrexate. Prespecified secondary analyses from the OPERA trial, where 180 early and treatment-naïve RA patients received methotrexate 20 mg once weekly in combination with either placebo or subcutaneous adalimumab 40 mg every other week. Serum lipid levels were measured at baseline and after 1 year. Changes in lipid levels were analysed using mixed linear models based on the intention-to-treat (ITT) population. Overall, 174 patients were included in the ITT population (adalimumab plus methotrexate n = 86; placebo plus methotrexate n = 88). Differences between changes in lipid levels were low-density lipoprotein cholesterol 0.18 mmol/l [95% CI - 0.05 to 0.42], total cholesterol 0.27 mmol/l [- 0.002 to 0.54], high-density lipoprotein cholesterol 0.05 mmol/l [- 0.06 to 0.15], triglycerides 0.11 mmol/l [- 0.08 to 0.29], very-low-density lipoprotein cholesterol 0.03 mmol/l [- 0.05 to 0.12], and non-high-density lipoprotein cholesterol 0.22 mmol/l [- 0.02 to 0.46]. In early RA patients treated to tight control of inflammation over a period of 1 year with either adalimumab plus methotrexate or placebo plus methotrexate, changes in lipid levels were similar. Trial registration number: NCT00660647.

Originalsprog Engelsk
Tidsskrift Rheumatology International
Vol/bind 41
Udgave nummer 3
Sider (fra-til) 543-549
Antal sider 7
ISSN 0172-8172
DOI
Status Udgivet - mar. 2021

Supervised exercise therapy compared with no exercise therapy to reverse debilitating effects of androgen deprivation therapy in patients with prostate cancer: a systematic review and meta-analysis

Ussing, A., Mikkelsen, M-L. K., Villumsen, B. R., Wejlgaard, J., Bistrup, P. E., Birkefoss, K. & Bandholm, T., 6 sep. 2021, (E-pub ahead of print) I: Prostate Cancer and Prostatic Diseases. s. 1-16 16 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Androgen deprivation therapy (ADT) in patients with prostate cancer can have several debilitating side effects. Supervised exercise is recommended to ameliorate these negative effects.

OBJECTIVE: To systematically evaluate the effect of supervised exercise therapy compared to no exercise therapy in patients with prostate cancer undergoing ADT, primarily according to the patient critical outcomes, 'disease-specific quality of life' and 'walking performance' measured at end of treatment.

METHODS: We searched PubMed/Medline, Embase, Cochrane Library, Cinahl and Pedro, to identify randomised controlled trials (RCTs), which investigated the effect of supervised exercise therapy compared to no exercise therapy in patients with prostate cancer receiving ADT, last search: June 2021. Two independent reviewers extracted data, and assessed risk of bias using Cochrane Risk of Bias Tool and evaluated the certainty of evidence using the GRADE-method.

RESULTS: Eigthteen RCTs (n = 1477) comprised patients with prostate cancer stages T1-T4 were included in the meta-analyses. Compared to no exercise therapy, supervised exercise therapy showed clinically relevant improvements in 'disease-specific quality of life' and 'walking performance'. The standardised mean differences were 0.43 (95% confidence interval (CI): 0.29, 0.58) and -0.41 (95% CI: -0.60, -0.22), respectively. The overall certainty of evidence was moderate due to serious risk of bias.

CONCLUSIONS: Evidence of moderate quality shows that supervised exercise therapy probably is superior to no exercise therapy in improving 'disease-specific quality of life' and 'walking performance' in patients with prostate cancer undergoing ADT. The results apply to all patients receiving androgen deprivation therapy regardless of cancer stage. The results support a strong recommendation for supervised exercise therapy for managing side effects in this population.

PROTOCOL REGISTRATION: NKR-38-Focused-questions-PICOs-for-updating1.ashx (sst.dk).

Originalsprog Engelsk
Tidsskrift Prostate Cancer and Prostatic Diseases
Sider (fra-til) 1-16
Antal sider 16
ISSN 1365-7852
DOI
Status E-pub ahead of print - 6 sep. 2021

Supervised training compared with no training or self-training in patients with subacromial pain syndrome: a systematic review and meta-analysis

Liaghat, B., Ussing, A., Petersen, B. H., Andersen, H. K., Barfod, K. W., Jensen, M. B., Hoegh, M., Tarp, S., Juul-Kristensen, B. & Brorson, S., 1 dec. 2021, I: Archives of Physical Medicine and Rehabilitation. 102, 12, s. 2428-2441 13 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: To study the effects of supervised training in adults with subacromial pain syndrome.

DATA SOURCES: Embase, MEDLINE, Cochrane Library, Cumulative Index to Nursing and Allied Health, and Physiotherapy Evidence Database were searched from inception to March 2020.

STUDY SELECTION: Independent reviewers selected randomized controlled trials comparing supervised training with (1) no training or (2) self-training in adults with subacromial pain syndrome lasting for at least 1 month. Critical outcomes were shoulder pain, function, and patient-perceived effect. Important outcomes included other potential benefits and adverse events at 3-month follow-up.

DATA EXTRACTION: Two independent reviewers extracted data for the meta-analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool 1, and certainty of evidence was evaluated using the Grades of Recommendation Assessment, Development, and Evaluation (GRADE).

DATA SYNTHESIS: Ten studies (n=597, 43% female) were included. Supervised training resulted in larger improvements than no training on pain (at rest: n=286; mean difference [MD], 1.68; 95% confidence interval [CI], 0.31-3.06 on 0-10 scale; during movement: n=353; MD, 1.84; 95% CI,0.91-2.76), function (n=396; standardized MD, 0.30; 95% CI, 0.07-0.52), and patient-perceived effect (n=118; risk ratio, 1.43; 95% CI, 0.87-2.34). Supervised training had potential benefits regarding quality of life, return to work, dropout, and training adherence, albeit more patients reported mild, transient pain after training. Supervised training and self-training showed equal improvements on pain (n=44) and function (n=76), with no data describing patient-perceived effect. Certainty of evidence was low for critical outcomes and low-moderate for other outcomes.

CONCLUSIONS: Supervised training might be superior to no training and equally effective as self-training on critical and important outcomes. Based on low-moderate certainty of evidence, these findings support a weak recommendation for supervised training in adults with subacromial pain syndrome.

Originalsprog Engelsk
Tidsskrift Archives of Physical Medicine and Rehabilitation
Vol/bind 102
Udgave nummer 12
Sider (fra-til) 2428-2441
Antal sider 13
ISSN 0003-9993
DOI
Status Udgivet - 1 dec. 2021

Systematic Literature Review and Meta-Analysis of the Relationship Between Polyunsaturated and Trans Fatty Acids During Pregnancy and Offspring Weight Development

Ren, X., Vilhjálmsdóttir, B. L., Rohde, J. F., Walker, K. C., Runstedt, S. E., Lauritzen, L., Heitmann, B. L. & Specht, I. O., 25 mar. 2021, I: Frontiers in nutrition. 8, s. 625596 625596.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and trans fatty acids (TFAs) may have an impact on offspring weight development. We conducted a systematic review and meta-analysis according to PRISMA guidelines to evaluate whether levels of these fatty acids during pregnancy influenced offspring weight development. Randomized controlled trials (RCTs) with DHA and/or EPA supplementation or cohort studies, which examined levels of DHA, EPA, or TFAs in maternal or neonatal blood samples and recorded offspring weight, were included. Overall, 27 RCTs and 14 observational studies were identified. The results showed that DHA and/or EPA supplementation doses >650 mg/day resulted in slightly higher birth weight (MD 87.5 g, 95% CI 52.3-122.6, n = 3,831) and combined BMI and BMI z score at 5-10 years (SMD 0.11, 95% CI 0.04-0.18, n = 3,220). These results were rated as moderate quality. Results from the observational studies were generally inconsistent. High TFA levels during pregnancy seemed to be associated with lower birth weight. Finally, this review and meta-analysis supports a relationship between high maternal or neonatal DHA and/or EPA levels and higher offspring birth weight and weight in childhood. More high-quality long-term studies are still needed.

Originalsprog Engelsk
Artikelnummer 625596
Tidsskrift Frontiers in nutrition
Vol/bind 8
Sider (fra-til) 625596
ISSN 2296-861X
DOI
Status Udgivet - 25 mar. 2021

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

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

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

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

Originalsprog Engelsk
Artikelnummer keab755
Tidsskrift Rheumatology (Oxford, England)
ISSN 1462-0324
DOI
Status E-pub ahead of print - 12 okt. 2021

Bibliografisk note

© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Test-retest Reliability for HAQ-DI and SF-36 PF for the Measurement of Physical Function in Psoriatic Arthritis

Leung, Y. Y., Tillett, W., Hojgaard, P., Orbai, A-M., Holland, R., Mathew, A. J., Goel, N., Chau, J., Lindsay, C. A., Ogdie, A., Coates, L. C., Christensen, R., Mease, P. J., Strand, V. & Gladman, D. D., okt. 2021, I: Journal of Rheumatology. 48, 10, s. 1547-1551 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Due to no existing data, we aimed to derive evidence to support test-retest reliability for the Health Assessment Questionnaire-Disability Index (HAQ-DI) and 36-item Short Form Health Survey physical functioning domain (SF-36 PF) in psoriatic arthritis (PsA).

METHODS: We identified datasets that collected relevant data for test-retest reliability for HAQ-DI and SF-36 PF, and evaluated them using Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology. We calculated intraclass correlation coefficients (ICC) as a measure of test-retest reliability. We then conducted a quality assessment and evaluated the adequacy of test-retest reliability performance.

RESULTS: Two datasets were identified for HAQ-DI and 1 for SF-36 PF in PsA. The quality of the datasets was good. The ICCs for HAQ-DI were good and excellent in study 1 (0.90, 95% CI 0.79-0.95) and study 2 (0.94, 95% CI 0.89-0.97). The ICC for SF-36 PF was excellent (0.96, 95% CI 0.92-0.98). The performance of test-retest reliability for both instruments was judged to be adequate.

CONCLUSION: The new data derived support good and reasonable test-retest reliability for HAQ-DI and SF-36 PF in PsA.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 48
Udgave nummer 10
Sider (fra-til) 1547-1551
Antal sider 5
ISSN 0315-162X
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 by the Journal of Rheumatology.

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

Originalsprog Engelsk
Tidsskrift International journal of obesity (2005)
ISSN 0307-0565
DOI
Status Udgivet - 20 okt. 2021

Bibliografisk note

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

The Danish Myelodysplastic Syndromes Database: Patient Characteristics and Validity of Data Records

Lauritsen, T. B., Nørgaard, J. M., Grønbæk, K., Vallentin, A. P., Ahmad, S. A., Hannig, L. H., Severinsen, M. T., Adelborg, K. & Østgård, L. S. G., 2021, I: Clinical Epidemiology. 13, s. 439-451 13 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: The Danish Myelodysplastic Syndromes Database (DMDSD) comprises nearly all patients diagnosed with myelodysplastic syndromes (MDS) in Denmark since 2010. The DMDSD has not yet been used for epidemiological research and the quality of registered variables remains to be investigated.

Objective: To describe characteristics of the patients registered in the DMDSD and to calculate predictive values and the proportion of missing values of registered data records.

Methods: We performed a nationwide cross-sectional validation study of recorded disease and treatment data on MDS patients during 2010-2019. Patient characteristics and the proportion of missing values were tabulated. A random sample of 12% was drawn to calculate predictive values with 95% confidence intervals (CIs) of 48 variables using information from medical records as a reference standard.

Results: Overall, 2284 patients were identified (median age: 76 years, men 62%). Of these, 10% had therapy-related MDS, and 6% had an antecedent hematological disease. Hemoglobin level was less than 6.2 mmol/L for 59% of patients. Within the first two years of treatment, 59% received transfusions, 35% received erythropoiesis-stimulating agents, and 15% were treated with a hypomethylating agent. For the majority of variables (around 80%), there were no missing data. A total of 260 medical records were available for validation. The positive predictive value of the MDS diagnosis was 92% (95% CI: 88-95). Predictive values ranged from 64% to 100% and exceeded 90% for 36 out of 48 variables. Stratification by year of diagnosis suggested that the positive predictive value of the MDS diagnosis improved from 88% before 2015 to 95% after.

Conclusion: In this study, there was a high accuracy of recorded data and a low proportion of missing data. Thus, the DMDSD serves as a valuable data source for future epidemiological studies on MDS.

Originalsprog Engelsk
Tidsskrift Clinical Epidemiology
Vol/bind 13
Sider (fra-til) 439-451
Antal sider 13
ISSN 1179-1349
DOI
Status Udgivet - 2021

Bibliografisk note

© 2021 Lauritsen et al.

The Effect of a Combined Gluten- and Casein-Free Diet on Children and Adolescents with Autism Spectrum Disorders: A Systematic Review and Meta-Analysis

Keller, A., Rimestad, M. L., Friis Rohde, J., Holm Petersen, B., Bruun Korfitsen, C., Tarp, S., Briciet Lauritsen, M. & Händel, M. N., feb. 2021, I: Nutrients. 13, 2, s. 1-18 18 s., 470.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

There has been a growing interest in the gastrointestinal system and its significance for autism spectrum disorder (ASD), including the significance of adopting a gluten-free and casein-free (GFCF) diet. The objective was to investigate beneficial and safety of a GFCF diet among children with a diagnosis of ASD. We performed a systematic literature search in Medline, Embase, Cinahl, and the Cochrane Library up to January 2020 for existing systematic reviews and individual randomized controlled trials (RCTs). Studies were included if they investigated a GFCF diet compared to a regular diet in children aged 3 to 17 years diagnosed with ASD, with or without comorbidities. The quality of the identified existing reviews was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR). The risk of bias in RCTs was assessed using the Cochrane Risk of Bias Tool, and overall quality of evidence was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE). We identified six relevant RCTs, which included 143 participants. The results from a random effect model showed no effect of a GFCF diet on clinician-reported autism core symptoms (standardized mean difference (SMD) -0.31 (95% Cl. -0.89, 0.27)), parent-reported functional level (mean difference (MD) 0.61 (95% Cl -5.92, 7.14)) or behavioral difficulties (MD 0.80 (95% Cl -6.56, 10.16)). On the contrary, a GFCF diet might trigger gastrointestinal adverse effects (relative risk (RR) 2.33 (95% Cl 0.69, 7.90)). The quality of evidence ranged from low to very low due to serious risk of bias, serious risk of inconsistency, and serious risk of imprecision. Clinical implications of the present findings may be careful consideration of introducing a GFCF diet to children with ASD. However, the limitations of the current literature hinder the possibility of drawing any solid conclusion, and more high-quality RCTs are needed. The protocol is registered at the Danish Health Authority website.

Originalsprog Engelsk
Artikelnummer 470
Tidsskrift Nutrients
Vol/bind 13
Udgave nummer 2
Sider (fra-til) 1-18
Antal sider 18
ISSN 2072-6643
DOI
Status Udgivet - feb. 2021

OBJECTIVE: This study investigated the effect of exercise therapy on inflammatory activity in synovitis and bone marrow lesions (BMLs) assessed by magnetic resonance imaging (MRI) in patients with knee OA.

METHODS: 60 patients with knee OA were randomized 1:1 to 12 weeks of supervised exercise therapy 3 times/week (ET) or a no-attention control group (CG). Synovitis and BMLs were assessed with static MRI with and without contrast and with dynamic contrast enhanced MRI (DCE-MRI). DCE-MRI data was quantified using pixel-by-pixel methodology based on analysis of signal intensity curves. Pain was assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS). Analyses of covariance were used assessing group differences in changes from baseline to week 12.

RESULTS: 33 patients adhered to the protocol and had valid MRI and KOOS data (ET, n = 16, CG, n = 17). Statistically significant and clinically relevant group difference in favour of ET was seen in KOOS pain change (-11.7 points, 95%CI: -20.1 to -3.4). There were statistically significant group differences in DCE-MRI assessed synovitis in the anterior synovium with unchanged inflammatory activity in the ET group compared to the CG. There were no group differences in BMLs and static MRI.

CONCLUSION: Inflammatory activity was unchanged, and pain was reduced in patients with knee OA adhering to 12 weeks of exercise therapy compared to a no-attention control group. The reduction in pain was not explained by changes in inflammatory activity. Overall, the results suggest that exercise is not harmful in knee OA. ClinicalTrials.gov number: NCT01545258.

Originalsprog Engelsk
Tidsskrift The Knee
Vol/bind 28
Udgave nummer 1
Sider (fra-til) 256-265
Antal sider 10
ISSN 0968-0160
DOI
Status Udgivet - jan. 2021

Bibliografisk note

Copyright © 2021 Elsevier B.V. All rights reserved.

The Effect of Metformin on Self-Selected Exercise Intensity in Healthy, Lean Males: A Randomized, Crossover, Counterbalanced Trial

Pilmark, N. S., Petersen-Bønding, C., Holm, N. F. R., Johansen, M. Y., Pedersen, B. K., Hansen, K. B. & Karstoft, K., 25 feb. 2021, I: Frontiers in Endocrinology. 12, s. 599164 599164.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Introduction: In general, patients with type 2 diabetes have lower cardiorespiratory fitness levels and perform exercise at lower intensities compared to healthy controls. Since metformin (MET) has been shown to increase the rate of perceived exertion (RPE) during exercise with a fixed intensity, MET per se may reduce self-selected exercise intensity. The aim of this study was to assess the effect of MET on self-selected exercise intensity.

Methods: Healthy males were eligible for this crossover, counterbalanced study with two treatment periods: MET and placebo (PLA), each lasting 17 days. Treatment dose was gradually increased and reached 2 g/day on treatment day 9, and continued at that level for the rest of the treatment period. The two periods were performed in randomized order. Two experimental days (A+B) were conducted on Day 15 (A) and Day 17 (B) of each period, respectively. Day A consisted of an exercise bout with self-selected exercise intensity (equal to RPE = 14-15 on the Borg Scale). Day B consisted of an exercise bout with fixed intensity (70% of VO2peak). Oxygen consumption rate was assessed continuously during both exercise bouts.

Results: Fifteen males (age 23.7 ± 0.6 years, BMI 22.3 ± 2.0, VO2peak 3.5 ± 0.6 L/min) were included in the study. On Day B, RPE was higher in MET compared to PLA (14.8 ± 0.4 vs. 14.0 ± 0.3, P = 0.045). On Day A, no difference in self-selected exercise intensity measured by oxygen consumption rate (PLA 2.33 ± 0.09 L O2/min, MET 2.42 ± 0.10 L O2/min, P = 0.09) was seen between treatment periods.

Conclusions: Self-selected exercise intensity was not reduced by MET in healthy males, despite the fact that MET increased RPE during an exercise bout with fixed intensity.

Originalsprog Engelsk
Artikelnummer 599164
Tidsskrift Frontiers in Endocrinology
Vol/bind 12
Sider (fra-til) 599164
ISSN 1664-2392
DOI
Status Udgivet - 25 feb. 2021

BACKGROUND: Lifestyle intervention, i.e. diet and physical activity, forms the basis for care of type 2 diabetes (T2D). The current physical activity recommendation for T2D is aerobic training for 150 min/week of moderate to vigorous intensity, supplemented with resistance training 2-3 days/week, with no more than two consecutive days without physical activity. The rationale for the recommendations is based on studies showing a reduction in glycated haemoglobin (HbA1c). This reduction is supposed to be caused by increased insulin sensitivity in muscle and adipose tissue, whereas knowledge about effects on abnormalities in the liver and pancreas are scarce, with the majority of evidence stemming from in vitro and animal studies. The aim of this study is to investigate the role of the volume of exercise training as an adjunct to dietary therapy in order to improve the pancreatic β-cell function in T2D patients less than 7 years from diagnosis. The objective of this protocol for the DOSE-EX trial is to describe the scientific rationale in detail and to provide explicit information about study procedures and planned analyses.

METHODS/DESIGN: In a parallel-group, 4-arm assessor-blinded randomised clinical trial, 80 patients with T2D will be randomly allocated (1:1:1:1, stratified by sex) to 16 weeks in either of the following groups: (1) no intervention (CON), (2) dietary intervention (DCON), (3) dietary intervention and supervised moderate volume exercise (MED), or (4) dietary intervention and supervised high volume exercise (HED). Enrolment was initiated December 15th, 2018, and will continue until N = 80 or December 1st, 2021. Primary outcome is pancreatic beta-cell function assessed as change in late-phase disposition index (DI) from baseline to follow-up assessed by hyperglycaemic clamp. Secondary outcomes include measures of cardiometabolic risk factors and the effect on subsequent complications related to T2D. The study was approved by The Scientific Ethical Committee at the Capital Region of Denmark (H-18038298).

TRIAL REGISTRATION: The Effects of Different Doses of Exercise on Pancreatic β-cell Function in Patients With Newly Diagnosed Type 2 Diabetes (DOSE-EX), NCT03769883, registered 10 December 2018 https://clinicaltrials.gov/ct2/show/NCT03769883 ). Any modification to the protocol, study design, and changes in written participant information will be approved by The Scientific Ethical Committee at the Capital Region of Denmark before effectuation.

DISCUSSION: The data from this study will add knowledge to which volume of exercise training in combination with a dietary intervention is needed to improve β-cell function in T2D. Secondarily, our results will elucidate mechanisms of physical activity mitigating the development of micro- and macrovascular complications correlated with T2D.

Originalsprog Engelsk
Artikelnummer 244
Tidsskrift Trials
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 244
ISSN 1745-6215
DOI
Status Udgivet - 1 apr. 2021

The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2

Maxwell, L. J., Beaton, D. E., Boers, M., D'Agostino, M. A., Conaghan, P. G., Grosskleg, S., Shea, B. J., Bingham Iii, C. O., Boonen, A., Christensen, R., Choy, E., Doria, A. S., Hill, C. L., Hofstetter, C., Kroon, F. P., Leung, Y. Y., Mackie, S., Meara, A., Touma, Z., Tugwell, P. & Wells, G. A., dec. 2021, I: Seminars in Arthritis and Rheumatism. 51, 6, s. 1320-1330 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument Selection Algorithm' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials.

METHODS: A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes.

RESULTS: OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property.

CONCLUSIONS: OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 6
Sider (fra-til) 1320-1330
Antal sider 11
ISSN 0049-0172
DOI
Status Udgivet - dec. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

The H2020 "NoHoW Project": A Position Statement on Behavioural Approaches to Longer-Term Weight Management

The EASO Obesity Management Task Force, apr. 2021, I: Obesity Facts. 14, 2, s. 246-258 13 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

There is substantial evidence documenting the effects of behavioural interventions on weight loss (WL). However, behavioural approaches to initial WL are followed by some degree of longer-term weight regain, and large trials focusing on evidence-based approaches to weight loss maintenance (WLM) have generally only demonstrated small beneficial effects. The current state-of-the-art in behavioural interventions for WL and WLM raises questions of (i) how we define the relationship between WL and WLM, (ii) how energy balance (EB) systems respond to WL and influence behaviours that primarily drive weight regain, (iii) how intervention content, mode of delivery and intensity should be targeted to keep weight off, (iv) which mechanisms of action in complex interventions may prevent weight regain and (v) how to design studies and interventions to maximise effective longer-term weight management. In considering these issues a writing team within the NoHoW Consortium was convened to elaborate a position statement, and behaviour change and obesity experts were invited to discuss these positions and to refine them. At present the evidence suggests that developing the skills to self-manage EB behaviours leads to more effective WLM. However, the effects of behaviour change interventions for WL and WLM are still relatively modest and our understanding of the factors that disrupt and undermine self-management of eating and physical activity is limited. These factors include physiological resistance to weight loss, gradual compensatory changes in eating and physical activity and reactive processes related to stress, emotions, rewards and desires that meet psychological needs. Better matching of evidence-based intervention content to quantitatively tracked EB behaviours and the specific needs of individuals may improve outcomes. Improving objective longitudinal tracking of energy intake and energy expenditure over time would provide a quantitative framework in which to understand the dynamics of behaviour change, mechanisms of action of behaviour change interventions and user engagement with intervention components to potentially improve weight management intervention design and evaluation.

Originalsprog Engelsk
Tidsskrift Obesity Facts
Vol/bind 14
Udgave nummer 2
Sider (fra-til) 246-258
Antal sider 13
ISSN 1662-4025
DOI
Status Udgivet - apr. 2021

The impact of early body-weight variability on long-term weight maintenance: exploratory results from the NoHoW weight-loss maintenance intervention

Turicchi, J., O'Driscoll, R., Lowe, M., Finlayson, G., Palmeira, A. L., Larsen, S. C., Heitmann, B. L. & Stubbs, J., mar. 2021, I: International journal of obesity (2005). 45, 3, s. 525-534 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Weight-loss programmes often achieve short-term success though subsequent weight regain is common. The ability to identify predictive factors of regain early in the weight maintenance phase is crucial.

OBJECTIVE: To investigate the associations between short-term weight variability and long-term weight outcomes in individuals engaged in a weight-loss maintenance intervention.

METHODS: The study was a secondary analysis from The NoHoW trial, an 18-month weight maintenance intervention in individuals who recently lost ≥5% body weight. Eligible participants (n = 715, 64% women, BMI = 29.2 (SD 5.0) kg/m2, age = 45.8 (SD 11.5) years) provided body-weight data by smart scale (Fitbit Aria 2) over 18 months. Variability in body weight was calculated by linear and non-linear methods over the first 6, 9 and 12 weeks. These estimates were used to predict percentage weight change at 6, 12, and 18 months using both crude and adjusted multiple linear regression models.

RESULTS: Greater non-linear weight variability over the first 6, 9 and 12 weeks was associated with increased subsequent weight in all comparisons; as was greater linear weight variability measured over 12 weeks (up to AdjR2 = 4.7%). Following adjustment, 6-week weight variability did not predict weight change in any model, though greater 9-week weight variability by non-linear methods was associated with increased body-weight change at 12 (∆AdjR2 = 1.2%) and 18 months (∆AdjR2 = 1.3%) and by linear methods at 18 months (∆AdjR2 = 1.1%). Greater non-linear weight variability measured over 12 weeks was associated with increased weight at 12 (∆AdjR2 = 1.4%) and 18 (∆AdjR2 = 2.2%) months; and 12-week linear variability was associated with increased weight at 12 (∆AdjR2 = 2.1%) and 18 (∆AdjR2 = 3.6%) months.

CONCLUSION: Body-weight variability over the first 9 and 12 weeks of a weight-loss maintenance intervention weakly predicted increased weight at 12 and 18 months. These results suggest a potentially important role in continuously measuring body weight and estimating weight variability.

Originalsprog Engelsk
Tidsskrift International journal of obesity (2005)
Vol/bind 45
Udgave nummer 3
Sider (fra-til) 525-534
Antal sider 10
ISSN 0307-0565
DOI
Status Udgivet - mar. 2021

The MIPAM trial – motivational interviewing and physical activity monitoring to enhance the daily level of physical activity among older adults – a randomized controlled trial

Larsen, R. T., Korfitsen, C. B., Keller, C., Christensen, J., Andersen, H. B., Juhl, C. & Langberg, H., dec. 2021, I: European Review of Aging and Physical Activity. 18, 1, 12.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: One in four older adults in Denmark and almost half of the very old above 75 do not meet the World Health Organization’s recommendations for a minimum of physical activity (PA). A cost-efficient and effective way to increase focus on and motivation for daily walking might be to use Physical Activity Monitors (PAMs) in combination with behavioural change intervention. Thus, the objective of this randomized controlled study was to investigate the effect of Motivational Interviewing (MI) as an add-on intervention to a PAM-based intervention measured in community-dwelling older adults. Methods: This two-arm parallel group randomized controlled effectiveness trial compared a 12-weeks PAM-based intervention with additional MI (PAM+MI group) with a PAM-based intervention alone (PAM group). The primary outcome, average daily step count, was analysed with a linear regression model, adjusted for sex and baseline daily step count. Following the intention-to-treat principle, multiple imputation based on baseline step count, sex and age was performed. Results: In total, 38 participants were randomized to the PAM intervention and 32 to the PAM+MI intervention arm. During the intervention period, PAM+MI participants walked on average 909 more steps per day than PAM participants, however insignificant (95%CI: − 71; 1889) and reported 2.3 points less on the UCLA Loneliness Scale (95%CI: − 4.5; − 1.24). Conclusion: The use of MI, in addition to a PAM-based intervention among older adults in PA promoting interventions hold a potential clinically relevant effect on physical activity and should thus be investigated further with adequately powered RCTs. Trial registration: This study was pre-registered in the clinicaltrials.gov database with identifier: NCT03906162.

Originalsprog Engelsk
Artikelnummer 12
Tidsskrift European Review of Aging and Physical Activity
Vol/bind 18
Udgave nummer 1
ISSN 1813-7253
DOI
Status Udgivet - dec. 2021

Bibliografisk note

Funding Information:
The content presented within this paper was produced as part of the REACH-project: this project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 690425 []. The funder (Horizon 2020) have not contributed to any work regarding this study protocol, nor had they any influence on the data-analysis, interpretation or decision on publication.

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

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

Di Giuseppe, D., Lindström, U., Aaltonen, K., Relas, H., Provan, S., Gudbjornsson, B., Hetland, M. L., Askling, J., Kauppi, M., Geirsson, A. J., Chatzidionysiou, K., Jørgensen, T. S., Dreyer, L., Michelsen, B., Jacobsson, L. & Glintborg, B., 23 dec. 2021, (E-pub ahead of print) I: Rheumatology (Oxford, England).

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
ISSN 1462-0324
DOI
Status E-pub ahead of print - 23 dec. 2021

Bibliografisk note

© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

The Prognostic Value of Pain Phenotyping in Relation to Treatment Outcomes in Patients with Axial Spondyloarthritis Treated in Clinical Practice: A Prospective Cohort Study

Andreasen, R. A., Kristensen, L. E., Egstrup, K., Baraliakos, X., Strand, V., Horn, H. C., Wied, J., Schiøttz-Christensen, B., Aalykke, C., Jensen Hansen, I. M., Ellingsen, T. & Christensen, R., 1 apr. 2021, I: Journal of Clinical Medicine. 10, 7, 1469.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Despite the control of inflammation, many patients with axial spondyloarthritis (axSpA) still report pain as a significant concern. Our objective was to explore the prognostic value of the painDETECT questionnaire (PDQ) in relation to treatment outcomes in axSpA patients treated in clinical practice. AxSpA patients with high disease activity initiating or switching a biological Disease-Modifying Antirheumatic Drug (bDMARD) were eligible. The PDQ score (range: -1 to 38) was used to distinguish participants with nociceptive pain (NcP) mechanisms from participants with a mixed pain mechanism (MP). The primary outcome was the proportion of individuals achieving a 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) at 12 weeks; logistic regression analysis models were used to determine the prognostic value of the nociceptive pain phenotype. Changes in continuous outcomes such as the Assessment of SpondyloArthritis International Society (ASAS) core outcome domains were analyzed using analysis of covariance (ANCOVA). Health-related quality of life (HR-QoL) was addressed using the Medical Outcomes Study SF-36. During a period of 22 months, 49 axSpA patients were included. Twenty (41%) had an NcP phenotype according to the PDQ score. BASDAI50 responses were reported by 40% (8/20) and 28% (8/29) NcP and MP groups, respectively. However, a prognostic value was not found in relation to the primary outcome (crude odds ratio [95% confidence interval]: 1.75 [0.52 to 5.87]). Across most of the secondary outcomes, axSpA NcP phenotype patients were reported having the most improvements in the HR-QoL measures. These data indicate the influence of personalized management strategies according to patients' pain phenotypes for stratification of axSpA patients in randomized controlled trials.

Originalsprog Engelsk
Artikelnummer 1469
Tidsskrift Journal of Clinical Medicine
Vol/bind 10
Udgave nummer 7
ISSN 2077-0383
DOI
Status Udgivet - 1 apr. 2021

The right to smoke and the right to smoke-free surroundings: international comparison of smoke-free psychiatric clinic implementation experiences

Freiburghaus, T., Raffing, R., Ballbè, M., Gual, A. & Tönnesen, H., 16 apr. 2021, I: BJPsych Open. 7, 3, s. e81 e81.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: In Scandinavia, people with a severe mental disorder have a reduced life expectancy of 15-20 years compared with the general public. Smoking is a major contributor, and smoke-free policies are increasingly adopted in psychiatric clinics around the world. We compared potential facilitators and barriers among staff and management, for the implementation of smoke-free psychiatric clinics.

AIMS: To investigate the attitudes and experiences regarding smoke-free policies among managers and staff involved in the implementation processes of smoke-free psychiatric clinics at hospitals in Malmö (Sweden) and Barcelona (Spain).

METHOD: We used a qualitative methodology, with 15 semi-structured interviews. The interviews were conducted with each participant individually, and were subsequently transcribed. The data were analysed with systematic text condensation.

RESULTS: There were notable differences in how the smoke-free policies were carried out and experienced, and attitudes regarding the policy changes differed in the two settings. Key differences were the views on the right to smoke in compulsory care and to stay in smoke-free surroundings supported by smoking cessation intervention; the prioritisation of staff facilitation of smoking breaks; and views on smoking and smoke-free psychiatry. In contrast, participants agreed on the importance of staff education and management support. A smoking ban by law and belonging to a network of smoke-free hospitals were also relevant.

CONCLUSIONS: Staff education, and support from staff and management for the patients' right to stay in smoke-free surroundings, facilitated successful implementation of smoke-free policies in the psychiatric clinics, whereas supporting the right to smoke was a barrier.

Originalsprog Engelsk
Artikelnummer e81
Tidsskrift BJPsych Open
Vol/bind 7
Udgave nummer 3
Sider (fra-til) e81
ISSN 2056-4724
DOI
Status Udgivet - 16 apr. 2021

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