Published in 2022

Financial incentives offered to those who quit smoking have been found effective, also in persons with low socioeconomic status (SES), but no previous study has investigated who benefits most: smokers with low or high SES. In this community-randomized trial ("Richer without smoking"), three Danish municipalities were randomized to reward persons who were abstinent when attending the municipal smoking cessation program (FIMs) and three municipalities were randomized to spend the same amount on smoking cessation campaigns recruiting smokers to the smoking cessation program (CAMs). The municipalities each received approximately USD 16,000. An intention-to-treat approach was used in analyses. In regression analyses adjusted for individual- and municipal-level differences, we found that smokers with high SES living in FIMs had significantly higher proportion of validated long-term successful quitters (OR (95% CI): 2.59 (1.6-4.2)) than high-SES smokers living in CAM. Smokers with low SES, however, did not experience the same benefit of financial incentives as smokers with high SES. Neither the FIMs nor the CAMs succeeded in attracting more smokers with low SES during the intervention year 2018 than the year before. Our study showed that smokers with low SES did not experience the same benefit of financial incentives as smokers with high SES.

Originalsprog Engelsk
Artikelnummer 10879
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 19
Udgave nummer 17
Sider (fra-til) 10879
ISSN 1661-7827
DOI
Status Udgivet - 31 aug. 2022

Background: There is a large unused potential for risk reduction in the preoperative period via effective lifestyle intervention targeting co-existing risky lifestyles: Smoking, malNutrition, obesity, risky Alcohol intake and insufficient Physical activity (SNAP). This trial compares the efficacy of the integrated STRONG programme with standard care on preoperative risk reduction and secondly on SNAP factor improvement and frailty, postoperative complications and quality of life. A nested interview study explores the patient preferences and the multi-perspective view of patients, relatives and health professionals. Methods: In total, 42 surgical patients with ≥1 SNAP factor are allocated to individually tailored STRONG programme or usual care during adjuvant chemotherapy prior to radical bladder cancer surgery. The STRONG programme has ≥6 weekly sessions with patient education, motivational and pharmaceutical support. It is based on intensive smoking and alcohol cessation interventions reporting perioperative quit rates > 50%. Surgical risk reduction is measured as ≥1 step for 1 or more risky lifestyles on the ASA-score, secondly as having no risky SNAP factors, and as any SNAP improvement. The outcomes are validated by measurements and biomarkers. Postoperative complications are categorised according to the Clavien-Dindo classification. Health-related quality of life is measured by EQ-5D. The patients are followed up after 6 weeks at surgery and 6 weeks and 6 months postoperatively. A representative sample of the participants, their relatives and the clinical staff are interviewed until data saturation. Transcription, triangulated analyses and data management are conducted using NVivo computer software. Discussion: The surgical agenda is characterised by fixed dates for surgery focusing on clear risk reduction within a short time. This requires a clinical useful lifestyle intervention programme with a high effect and coverage as well as containing all SNAP factors and tailored to individual needs. The STRONG programme seems to meet these requirements. After development in multi-professional collaboration, STRONG is delivered by a specially trained nurse as part of the surgical patient journey. Overall, this study will bring important new knowledge about risk reduction in a frail patient group undergoing major cancer surgery. Trial registration: Registration at www.clintrials.gov (NCT04088968) The manuscript form from https://trialsjournal.biomedcentral.com/bmc/journal and the SPIRIT guidelines are followed.

Originalsprog Engelsk
Artikelnummer 333
Tidsskrift Trials
Vol/bind 23
Udgave nummer 1
Sider (fra-til) 333
ISSN 1745-6215
DOI
Status Udgivet - 21 apr. 2022

Bibliografisk note

Funding Information:
The Danish Cancer Society (R223-A13094): 2.9 mill. DKK (part of the COMPAS Project receiving 20 mill DKK); Novo Nordic Foundation (NNF19OC0058924): 0.6 mill DKK; the Parker Institute, Bispebjerg-Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

Funding Information:
HT and SVL conceived the study and drafted the manuscript. HT, LNL, UNJ, HP and SVL designed the study. LNL, UNJ, HP and SVL are local investigators at the participating centre. The study is supervised and coordinated by HT, UNJ, HP and SVL. HT and SVL are responsible for the accurate execution of the study. All authors approved the final manuscript. The funders play no role in the conceptualism, the design, collection, management, analyses and interpretation of data, writing the report for publications or have ultimate authority over any of these activities. The Danish Cancer Society (R223-A13094): 2.9 mill. DKK (part of the COMPAS Project receiving 20 mill DKK); Novo Nordic Foundation (NNF19OC0058924): 0.6 mill DKK; the Parker Institute, Bispebjerg-Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). The final trial data for this protocol can be supplied on request.

Publisher Copyright:
© 2022, The Author(s).

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., sep. 2022, I: Prostate Cancer and Prostatic Diseases. 25, 3, s. 491-506 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
Vol/bind 25
Udgave nummer 3
Sider (fra-til) 491-506
Antal sider 16
ISSN 1365-7852
DOI
Status Udgivet - sep. 2022

Sustained Resolution of Nail Psoriasis Through 5 Years with Ixekizumab: A Post-Hoc analysis from UNCOVER-3

Egeberg, A., Kristensen, L. E., Vender, R., Zaheri, S., El Baou, C., Gallo, G., Riedl, E. & Schuster, C., 10 okt. 2022, I: Acta Dermato-Venereologica. 102, s. adv00787

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Nail psoriasis is a chronic, difficult-to-treat condition affecting almost half of patients with psoriasis. It is associated with considerable social stigma and impairment of patients' quality of life. The aim of this study was to assess improvements in objective measures of nail psoriasis among patients from the long-term extension of the UNCOVER-3 study who received the interleukin-17A inhibitor ixekizumab and had either any degree of nail psoriasis (Nail Psoriasis Severity Index (NAPSI) >=1) or significant nail psoriasis (fingernail NAPSI ≥ 16 and ≥ 4 fingernails involved) at baseline. Efficacy outcomes reported through week 264 included the mean percentage improvements from baseline in NAPSI score and the proportion of patients achieving nail psoriasis resolution (NAPSI=0). In UNCOVER-3, 56.9% (219/385) of patients had nail psoriasis at baseline; of those, 61.2% (134/219) had significant nail psoriasis. At week 60, a total of 66.9% and 59.1% of patients with baseline nail psoriasis and significant baseline nail psoriasis, respectively, reported complete clearance of nail psoriasis, an effect which was sustained through week 264. This analysis demonstrates that continuous treatment with ixekizumab in adult patients with moderate-to-severe-psoriasis through 264 weeks was associated with improvements and clearance of fingernail psoriasis, irrespective of the severity of nail psoriasis at baseline.

Originalsprog Engelsk
Tidsskrift Acta Dermato-Venereologica
Vol/bind 102
Sider (fra-til) adv00787
ISSN 0001-5555
DOI
Status Udgivet - 10 okt. 2022

OBJECTIVES: In a 2-year follow-up study of patients with axial spondyloarthritis (axSpA) in clinical remission who tapered TNF 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 and reduced dose, respectively) 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% CI: 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 smoker (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 2 years following a clinical guideline, 52% of patients with axSpA in clinical remission had successfully tapered TNFi, only 1% discontinued. Baseline physician global score was an independent predictor of successful tapering.

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

Bibliografisk note

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

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

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

Bibliografisk note

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

The correlation between illness perception, pain intensity and quality of life in elderly with low back pain in Denmark: a cross-sectional study

Ginnerup-Nielsen, E., Harreby, M., Christensen, R., Bliddal, H. & Henriksen, M., 2022, I: PeerJ. 10, s. e14129 e14129.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Illness perception is related to management patterns and pain intensity, but among elderly with low back pain, this relation is unclear. The aims of this study were to analyse the associations between illness perception, pain intensity and health related quality of life in a group of elderly with low back pain and explore how different illness perception profiles would cluster and differ in terms of pain, quality of life and choice of management.

Method: This was a cross-sectional survey based on a cohort of originally 640 Danish children. Of the 311 respondents in 2019, 69% reported low back pain within last year and were included. Associations between illness perceptions (Brief illness perception questionnaire), health related quality of life (EuroQol-5 Domain-3L) and low back pain intensity were assessed, and participants were clustered based on their perceptions using hierarchical and K-means cluster analysis. Cluster differences in pain, quality of life and use of pharmacological and non-pharmacological treatments were explored.

Results: Among the 213 individuals with low back pain, 33% reported severe or fluctuating pain intensity. Higher pain intensity was associated with perceiving low back pain as a greater threat. Participants reporting fluctuating pain perceived their low back pain almost as threatening as participants reporting severe pain. Two clusters were identified. Cluster 1 reported lower quality of life (difference in medians: -0.176 (95% CI [-0.233--0.119 ])) and was more likely to report severe or fluctuating pain (37.7% vs. 4.5% [
P < 0.0001]) and to use pharmacological treatments than Cluster 2 (37.7% vs. 14.9% [
P < 0.001]). No association was found between clusters concerning use of non-pharmacological treatments (
P = 0.134).

Conclusion: Based on illness perceptions, two clusters differing in pain intensity, quality of life and use of pharmacological treatments were identified. Targeting illness perceptions may be beneficial during rehabilitation or when guiding patients with low back pain in choice of management.

Originalsprog Engelsk
Artikelnummer e14129
Tidsskrift PeerJ
Vol/bind 10
Sider (fra-til) e14129
ISSN 2167-8359
DOI
Status Udgivet - 2022

Bibliografisk note

©2022 Ginnerup-Nielsen et al.

The effect of gluten in adolescents and young adults with gastrointestinal symptoms: a blinded randomised cross-over trial

Crawley, C., Savino, N., Halby, C., Sander, S. D., Andersen, A-M. N., Arumugam, M., Murray, J., Christensen, R. & Husby, S., maj 2022, I: Alimentary Pharmacology and Therapeutics. 55, 9, s. 1116-1127 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The popularity of the gluten-free diet and sales of gluten-free products have increased immensely.

AIMS: To investigate whether gluten induces gastrointestinal symptoms, measured by self-reported questionnaires, as well as mental health symptoms in adolescents from a population-based cohort.

METHODS: The eligible participants (n = 273) were recruited from a population-based cohort of 1266 adolescents and had at least four different gastrointestinal symptoms. Phase one (n = 54) was a run-in phase where the participants lived gluten-free for 2 weeks. If they improved they continued to phase 2 (n = 33), a blinded randomised cross-over trial. Participants were blindly randomised either to start with 7 days of gluten, eating two granola bars containing 10 g of gluten or to 7 days on placebo, eating two granola bars without gluten, followed by the reverse and separated by a 7-day washout period. The effects of the intervention on gastrointestinal symptoms and mental health symptoms were assessed.

RESULTS: In total, 54/273 participants entered the run-in phase and 35 were eligible for randomization. A total of 33 were randomised and 32 completed the trial. The median age was 20.3 (IQR 19.2-20.9) and 32/33 participants were females. Compared with a placebo, gluten did not induce gastrointestinal symptoms. The difference in the average VAS was -0.01 (95% confidence interval -2.07 to 2.05). Nor did we find a difference in the outcomes measuring mental health.

CONCLUSION: Compared with placebo, adding gluten to the diet did not induce gastrointestinal symptoms or worsened mental health in adolescents recruited from a population-based cohort. The trial registration number is NCT04639921.

Originalsprog Engelsk
Tidsskrift Alimentary Pharmacology and Therapeutics
Vol/bind 55
Udgave nummer 9
Sider (fra-til) 1116-1127
Antal sider 12
ISSN 0269-2813
DOI
Status Udgivet - maj 2022

Bibliografisk note

© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

OBJECTIVES: The primary objective was to compare the effect of cognitive behavioural therapy for insomnia (CBT-I) to usual care on sleep efficiency, measured by polysomnography (PSG) immediately after the intervention at week 7. Secondary objectives included comparing the longer-term effect on sleep- and RA-related outcomes at week 26.

METHODS: In a randomised controlled trial using a parallel group design, the experimental intervention was six weeks' nurse-led group-based CBT-I; the comparator was usual care. Analyses were based on the intention-to-treat (ITT) principle; missing data were statistically modelled using repeated-measures linear mixed effects models adjusted for the level at baseline.

RESULTS: The ITT population consisted of 62 patients (89% women), with an average age of 58 years and an average sleep efficiency of 83.1%. At primary end point, sleep efficiency was 88.7% in the CBT-I group, compared with 83.7% in the control group (difference: 5.03 [95% CI -0.37-10.43]; p = 0.068) measured by PSG at week 7. Key secondary outcomes measured with PSG had not improved at week 26. However, for all the patient-reported key secondary sleep- and RA-related outcomes, there were statistically highly significant differences between CBT-I and usual care (p < 0.0001), e.g. insomnia (Insomnia Severity Index: -9.85 [95% CI -11.77 to -7.92]), and the RA impact of disease (RAID: -1.36 [95% CI-1.92 to -0.80]) at week 26.

CONCLUSION: Nurse-led group-based CBT-I did not lead to an effect on sleep efficiency objectively measured with PSG. However, CBT-I showed improvement on all patient-reported key secondary sleep- and RA-related outcomes measured at week 26.Trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT03766100.

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

Bibliografisk note

© The Author(s) 2022. 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 effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: results from KEEPsAKE 1 and 2

Kristensen, L. E., Soliman, A. M., Papp, K., Barcomb, L., Eldred, A. & Östör, A., nov. 2022, I: Journal of the European Academy of Dermatology and Venereology : JEADV. 36, 11, s. 2120-2129 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that reduces the quality of life. This study assessed the effects of risankizumab (RZB) on the achievement of minimal clinically important differences (MCID) in patient-reported outcomes (PROs).

METHODS: KEEPsAKE-1 and -2 are randomized, placebo-controlled Phase 3 clinical studies assessing RZB (150 mg) vs. placebo (PBO) in adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs and/or biologics. Patients were randomized 1:1 to receive RZB or PBO for 24 weeks; starting at Week 24, all patients received RZB 150 mg through Week 52. PROs assessed were Patient's Global Assessment of Disease Activity (PtGA), Patient's Assessment of Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Short-Form 36 Physical and Mental Component Summary scores (PCS and MCS, respectively), 5-Level EQ-5D (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and Work Productivity and Activity Impairment (WPAI). The proportion of patients achieving MCID at Weeks 24 and 52 are reported. Odds ratios of achieving MCID with RZB treatment at Week 24, relative to PBO, were estimated by logistic regression controlling for baseline and stratification factors.

RESULTS: In KEEPsAKE-1, RZB- vs. PBO-treated patients were more likely to report MCID in all PROs at Week 24; similar results were obtained in KEEPsAKE-2, except for SF-36 MCS and WPAI presenteeism domain. In KEEPsAKE-1 and KEEPsAKE-2, 65% and 62% of RZB-treated patients, respectively, reported MCID in PtGA at Week 24, which increased to 74% and 68%, respectively, at Week 52. Approximately 48% of all PBO-treated patients reported MCID in PtGA at Week 24 and, after initiating RZB, >65% reported MCID at Week 52. Results were similar in the remaining PROs.

CONCLUSIONS: These data demonstrate that patients with PsA receiving RZB treatment are more likely to report clinically important improvements in PROs compared with patients receiving PBO.

Originalsprog Engelsk
Tidsskrift Journal of the European Academy of Dermatology and Venereology : JEADV
Vol/bind 36
Udgave nummer 11
Sider (fra-til) 2120-2129
Antal sider 10
ISSN 0926-9959
DOI
Status Udgivet - nov. 2022

Bibliografisk note

© 2022 AbbVie Inc and The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial

Thorsen, I. K., Yang, Y., Valentiner, L. S., Glümer, C., Karstoft, K., Brønd, J. C., Nielsen, R. O., Brøns, C., Christensen, R., Nielsen, J. S., Vaag, A. A., Pedersen, B. K., Langberg, H. & Ried-Larsen, M., 28 sep. 2022, I: JMIR mHealth and uHealth. 10, 9, s. e30602 e30602.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required.

OBJECTIVE: The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach in municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D.

METHODS: The study was designed as a parallel-group, randomized trial with 52 weeks' intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app-based interval walking training (IWT; IWT group; n=140), or (2) standard care + the standard exercise program (StC group; n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app-based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (minutes/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health-related quality of life (HRQoL), physical fitness, weight, and waist circumference.

RESULTS: Participants had a mean age of 59.6 (SD 10.6) years and 128/214 (59.8%) were men. No changes in MVPA time were observed from baseline to 52-week follow-up in the StC and IWT groups (least squares means [95% CI] 0.6 [-4.6 to 5.8] and -0.2 [-3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI] -0.8 [-8.1 to 6.4] minutes/day; P=.82). Physical HRQoL increased by a mean of 4.3 (95% CI 1.8 to 6.9) 12-item Short-Form Health Survey (SF-12) points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased a mean of -2.3 (95% CI -4.1 to -0.4) cm more in the IWT group compared with the StC group but with a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes.

CONCLUSIONS: Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app-based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02341690; https://clinicaltrials.gov/ct2/show/NCT02341690.

Originalsprog Engelsk
Artikelnummer e30602
Tidsskrift JMIR mHealth and uHealth
Vol/bind 10
Udgave nummer 9
Sider (fra-til) e30602
ISSN 2291-5222
DOI
Status Udgivet - 28 sep. 2022

Bibliografisk note

©Ida Kær Thorsen, Yanxiang Yang, Laura Staun Valentiner, Charlotte Glümer, Kristian Karstoft, Jan Christian Brønd, Rasmus Oestergaard Nielsen, Charlotte Brøns, Robin Christensen, Jens Steen Nielsen, Allan Arthur Vaag, Bente Klarlund Pedersen, Henning Langberg, Mathias Ried-Larsen. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 28.09.2022.

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

Bibliografisk note

Copyright © 2022 by The North American Menopause Society.

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

Di Giuseppe, D., Lindström, U., Aaltonen, K., Relas, H., Provan, S., Gudbjornsson, B., Hetland, M. L., Askling, J., Kauppi, M., Geirsson, A. J., Chatzidionysiou, K., Jørgensen, T. S., Dreyer, L., Michelsen, B., Jacobsson, L. & Glintborg, B., 30 aug. 2022, I: Rheumatology (Oxford, England). 61, 9, s. 3647-3656 10 s.

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, ≥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 (2009-2011, 2012-2013, 2014-2015, 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 8398 patients included, 6056 patients (63% male, median age 42 years) started a first b/tsDMARD in 2009-2015, whereof proportions treated with ≥3, ≥4 or ≥5 b/tsDMARDs within 3 years' follow-up were 8%, 3% and 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 extra-articular manifestations illustrating the ongoing challenge of treating this patient group.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 61
Udgave nummer 9
Sider (fra-til) 3647-3656
Antal sider 10
ISSN 1462-0324
DOI
Status Udgivet - 30 aug. 2022

Bibliografisk note

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

BACKGROUND & OBJECTIVE: It has been suggested that prenatal vitamin D plays a role in the development of childhood asthma and wheeze. Several systematic reviews have been conducted, but the results are inconsistent, and the methodological quality has not been studied. Therefore, the objective of this umbrella review was to assess the internal validity of the evidence base and the evidence for an association between prenatal vitamin D and asthma or wheezing in the offspring.

METHODS: We searched the electronic databases Embase, PubMed, and Cochrane Library for studies on prenatal vitamin D using search words such as vitamin D, 25-hydroxyvitamin D, calcidiol, fetal, and neonatal. The search was conducted in June 2020, and the databases were searched from their date of establishment. We included systematic reviews and/or meta-analyses of experimental and observational studies assessing the association between prenatal vitamin D or asthma and wheeze. We excluded narrative reviews, commentaries, and other umbrella reviews. The methodological quality of systematic reviews was assessed using AMSTAR 2 tool. PROSPERO reg. no. CRD42020151329.

RESULTS: We identified 22 eligible systematic reviews (17 on asthma and 20 on wheeze). Using the AMSTAR 2 quality assessment tool, the methodological quality was rated as critically low in 21 out of 22 systematic reviews, suggesting that previous reviews and meta-analyses did not provide accurate and comprehensive summaries of the included studies and that conclusions reached were potentially flawed. The majority of the included reviews reported that prenatal vitamin D reduces the risk of wheeze in the offspring.

CONCLUSION: Prior to informing public guidelines, high-quality systematic reviews of the current evidence are greatly warranted.

Originalsprog Engelsk
Tidsskrift Clinical nutrition (Edinburgh, Scotland)
Vol/bind 41
Udgave nummer 8
Sider (fra-til) 1808-1817
Antal sider 10
ISSN 0261-5614
DOI
Status Udgivet - aug. 2022

Bibliografisk note

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

The ongoing Coronavirus Disease (COVID-19) pandemic has so far affected more than 500 million people. Lingering fatigue and cognitive difficulties are key concerns because they impede productivity and quality of life. However, the prevalence and duration of neurocognitive sequelae and association with functional outcomes after COVID-19 are unclear. This longitudinal study explored the frequency, severity and pattern of cognitive impairment and functional implications 1 year after hospitalisation with COVID-19 and its trajectory from 3 months after hospitalisation. Patients who had been hospitalised with COVID-19 from our previously published 3-months study at the Copenhagen University Hospital were re-invited for a 1-year follow-up assessment of cognitive function, functioning and depression symptoms. Twenty-five of the 29 previously assessed patients (86%) were re-assessed after 1 year (11±2 months). Clinically significant cognitive impairments were identified in 48-56 % of patients depending on the cut-off, with verbal learning and executive function being most severely affected. This was comparable to the frequency of impairments observed after 3 months. Objectively measured cognitive impairments scaled with subjective cognitive difficulties, reduced work capacity and poorer quality of life. Further, cognitive impairments after 3 months were associated with the severity of subsequent depressive symptoms after 1 year. In conclusion, the stable cognitive impairments in approximately half of patients hospitalized with COVID-19 and negative implications for work functioning, quality of life and mood symptoms underline the importance of screening for and addressing cognitive sequelae after severe COVID-19.

Originalsprog Engelsk
Tidsskrift European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology
Vol/bind 59
Sider (fra-til) 82-92
Antal sider 11
ISSN 0924-977X
DOI
Status Udgivet - jun. 2022

Bibliografisk note

Copyright © 2022. Published by Elsevier B.V.

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

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

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

Bibliografisk note

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

The Danish Health Authority develops clinical practice guidelines to support clinical decision-making based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system and prioritizes using Cochrane reviews. The objective of this study was to explore the usefulness of Cochrane reviews as a source of evidence in the development of clinical recommendations. Evidence-based recommendations in guidelines published by the Danish Health Authority between 2014 and 2021 were reviewed. For each recommendation, it was noted if and how Cochrane reviews were utilized. In total, 374 evidence-based recommendations and 211 expert consensus recommendations were published between 2014 and 2021. Of the 374 evidence-based recommendations, 106 included evidence from Cochrane reviews. In 28 recommendations, all critical and important outcomes included evidence from Cochrane reviews. In 36 recommendations, a minimum of all critical outcomes included evidence from Cochrane reviews, but not all important outcomes. In 33 recommendations, some but not all critical outcomes included evidence from Cochrane reviews. Finally, in nine recommendations, some of the important outcomes included evidence from Cochrane reviews. In almost one-third of the evidence-based recommendations, Cochrane reviews were used to inform clinical recommendations. This evaluation should inform future evaluations of Cochrane review uptake in clinical practice guidelines concerning outcomes important for clinical decision-making.

Originalsprog Engelsk
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 19
Udgave nummer 2
ISSN 1661-7827
DOI
Status Udgivet - 7 jan. 2022

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

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

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

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

Bibliografisk note

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

Users' perspective on rehabilitation interventions for young adult cancer survivors: A group concept mapping study

Aagesen, M., Pilegaard, M. S., Hauken, M. A., Waehrens, E. E. E. & la Cour, K., nov. 2022, I: European Journal of Cancer Care. 31, 6, s. e13734

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: We aim to identify and prioritise rehabilitation interventions to strengthen participation in everyday life for young adult cancer survivors (YACS) between 18 and 39 years, involving the perspectives of YACS and relevant stakeholders.

METHODS: A group concept mapping study was conducted in Denmark from 2019 to 2020. Online, participants generated and sorted ideas followed by rating their importance. Multidimensional scaling followed by hierarchical cluster analyses were applied to generate a cluster rating map of the prioritised interventions, which participants validated at a face-to-face meeting. Finally, a concluding conceptual model of prioritised rehabilitation intervention for YACS was developed.

RESULTS: The study involved 25 YACS, three family members and 31 professionals working with YACS. The conceptual model included 149 ideas classified into eight intervention components created by the participants: (1) Treatment and possibilities within the social and healthcare system, (2) Rights and Finance, (3) Education and Work, (4) Psychological problems, (5) Body and Everyday Life, (6) Peer-to-peer, (7) Sexuality and Relationships and (8) Family and Friends. All components were rated equally important, whereby 17 ideas across the eight components were rated very important.

CONCLUSION: This study indicates that rehabilitation of YACS should be composed of eight equally important intervention components requiring an interdisciplinary approach.

Originalsprog Engelsk
Tidsskrift European Journal of Cancer Care
Vol/bind 31
Udgave nummer 6
Sider (fra-til) e13734
ISSN 0961-5423
DOI
Status Udgivet - nov. 2022

Bibliografisk note

© 2022 The Authors. European Journal of Cancer Care published by John Wiley & Sons Ltd.

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