Published in 2021

Breast cancer rate after oophorectomy: A Prospective Danish Cohort Study

Koch, T., Jørgensen, J. T., Christensen, J., Dehlendorff, C., Priskorn, L., Simonsen, M. K., Duun-Henriksen, A. K., Andersen, Z. J., Juul, A., Bräuner, E. V. & Hickey, M., 1 aug. 2021, I: International Journal of Cancer. 149, 3, s. 585-593 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The association between oophorectomy and risk of breast cancer in the general population is uncertain. The aim of our study was to determine the breast cancer rate in women from the general population after oophorectomy (performed before/after menopause), and whether this varies by use of hormone replacement therapy (HRT), hysterectomy, body mass index (BMI) and shift work. The study included 24 409 female nurses (aged ≥45 years) participating in the Danish Nurse Cohort. Nurses were followed from cohort entry until date of breast cancer, death, emigration or end of follow-up at 31 December 2018, whichever came first. Poisson regression with log-transformed person-years as the offset examined the association between oophorectomy and breast cancer (all ages and stratified by menopausal status at time of oophorectomy). The potential modifying effect of HRT use, hysterectomy, BMI and shift work on the associations was estimated. During 502 463 person-years of follow-up, 1975 (8.1%) nurses were diagnosed with breast cancer. Bilateral oophorectomy was associated with a reduced breast cancer rate compared to nurses with preserved ovaries, adjusted rate ratio (95% confidence interval): 0.79 (0.64; 0.99). Similar associations (magnitude and direction) were detected for unilateral oophorectomy and when stratifying according to menopausal status at time of oophorectomy, but without statistical significance. Unilateral and bilateral oophorectomy is associated with a reduced breast cancer rate in women from the general population. This association is not modified by use of HRT, hysterectomy, BMI or shift work.

Originalsprog Engelsk
Tidsskrift International Journal of Cancer
Vol/bind 149
Udgave nummer 3
Sider (fra-til) 585-593
Antal sider 9
ISSN 0020-7136
DOI
Status Udgivet - 1 aug. 2021

Change in psoriatic arthritis outcome measures impacts SF-36 physical and mental component scores differently: an observational cohort study

Skougaard, M., Jørgensen, T. S., Jensen, M. J., Ballegaard, C., Guldberg-Møller, J., Egeberg, A., Christensen, R., Benzin, P., Stisen, Z. R., Merola, J. F., Coates, L. C., Strand, V., Mease, P. & Kristensen, L. E., 2021, I: Rheumatology Advances in Practice. 5, 3, s. rkab076

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Objective: The objective was to investigate interplay and physical and mental component scores between change (Δ) in health-related quality of life (HRQoL) quantified by the physical component score (PCS) and mental component score (MCS) retrieved from short-form health survey (SF-36), change in disease activity (ΔDAS28CRP) and manifestations of PsA.

Methods: PsA patients initiating new medical therapy were enrolled. Independent disease measures evaluating disease activity, enthesitis, psoriasis, pain and fatigue were collected at treatment initiation and after 4 months. Interplay between independent disease measures and dependent outcome measures, ΔPCS and ΔMCS, was described with univariate regression analyses. Multivariate regression analyses were applied to assess the impact of independent variables, such as individual disease outcome measures vs ΔDAS28CRP on ΔPCS and ΔMCS.

Results: One hundred and eight PsA patients were included. In the univariate regression analyses, improvement in fatigue, pain and disability were associated with improvement in ΔPCS (β; -2.08, -0.18 and -13.00, respectively; all P < 0.001) and ΔMCS (β; -1.59, -0.12 and -6.07, respectively; P < 0.001, P < 0.001 and P = 0.003, respectively). When patient-reported outcomes were included in the final multivariate models, improvements in ΔPCS and ΔMCS were associated with improvements in pain, fatigue and disability (P < 0.001). Improvement in enthesitis impacted ΔPCS positively (β -0.31, P < 0.001). No association was found between change in skin psoriasis, ΔPCS and ΔMCS (β 0.15, P = 0.056 and β 0.05, P = 0.561, respectively).

Conclusion: In this PsA patient cohort, diminishing pain, disability and fatigue improved PCS and MCS significantly. Changes in enthesitis and psoriasis did not grossly impact HRQoL compared with DAS28CRP. Individual PsA manifestations influence HRQoL differently, which is important clinically when targeting treatment.

Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02572700.

Originalsprog Engelsk
Tidsskrift Rheumatology Advances in Practice
Vol/bind 5
Udgave nummer 3
Sider (fra-til) rkab076
ISSN 2514-1775
DOI
Status Udgivet - 2021

Bibliografisk note

© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Unintended negative outcomes on child behavior due to lockdown and home confinement following the corona virus disease (COVID-19) pandemic needs highlighting to effectively address these issues in the current and future health crises. In this sub-study of the ODIN-study, the objectives were to determine whether the Danish lockdown and home confinement following the COVID-19 pandemic affected changes in emotional-behavioral functioning of pre-school-aged children using the validated Strength and Difficulties Questionnaire (SDQ) answered by parents shortly before lockdown and 3 weeks into lockdown, and moreover, to examine whether baseline family and social characteristics could predict change in child emotional-behavioral functioning during lockdown. Parents of 40 (82%) children with a mean(SD) age of 5.0(0.7) completed the baseline questionnaire and the lockdown follow-up questionnaire. The SDQ-Total difficulties score (SDQ-TD) and Prosocial Behavioral score (PSB) changed significantly from pre- to lockdown [SDQ-TD mean(SD): 6.0(3.8) and 7.9(5.2); P = 0.02, respectively and PSB mean(SD): 8.5(1.4) and 7.9(1.5); P = 0.03, respectively]. Attending leisure time activities before lockdown was a predicting factor of changes to the worse in the children's SDQ-TD scores, with a mean difference in SDQ-TD between those with and without activities of 3.16 (95%CI 0.27-6.12); P = 0.03. In conclusion, the study showed a modest decrease in child-emotional behavioral functioning during the COVID-19 lockdown, potentially due to parental stress. Although these results might not be generalizable due to small sample size and selected population, the results point to a need of a greater awareness of child mental wellbeing during a lockdown situation.

Originalsprog Engelsk
Artikelnummer 643057
Tidsskrift Frontiers in Psychology
Vol/bind 12
Sider (fra-til) 643057
ISSN 1664-1078
DOI
Status Udgivet - 31 maj 2021

INTRODUCTION: Patients addicted to alcohol or drug often have additional unhealthy lifestyles, adding to the high mortality and morbidity in this patient group. Therefore, it is important to consider lifestyle interventions as part of the usual addiction treatment.

OBJECTIVE: The aim was to identify predictors of successful changes in lifestyle risk factors among patients in treatment for alcohol or drug addiction.

METHODS: We conducted a secondary analysis of a trial using a 6-week intensive integrated lifestyle intervention: The very integrated program (VIP). Patients were recruited in Addiction Centres Malmö and Psychiatry Skåne, Sweden. The primary outcome was successful changes in lifestyle, measured as quitting tobacco, exercising 30 min per day, and not being over- or underweight after 6 weeks and 12 months.

RESULTS: A total of 212 patients were included in the RCT, and 128 were included in this secondary analysis: 108 at 6 weeks and 89 at 12 months of follow-up. A total of 69 patients were respondents at both follow-ups. The follow-up rates were 51 and 42%, respectively. More education, having at least 2 lifestyle risk factors and having a high quality of life were predictors of a successful change in lifestyle after 6 weeks. After 12 months, the predictors for a successful outcome were having 3 or more risk factors, while an education level up to 3 years was a negative predictor.

CONCLUSIONS: Having several unhealthy lifestyles in addition to alcohol and drug addiction was a significant predictor of successful lifestyle changes in the short- and long term after the VIP for lifestyle interventions. Likewise, education was significant. The results should be considered in future development and research among this vulnerable group of patients.

Originalsprog Engelsk
Tidsskrift European addiction research
Vol/bind 27
Udgave nummer 2
Sider (fra-til) 123-130
Antal sider 8
ISSN 1022-6877
DOI
Status Udgivet - mar. 2021

Chronic Sequelae After Muscle Strain Injuries: Influence of Heavy Resistance Training on Functional and Structural Characteristics in a Randomized Controlled Trial

Bayer, M. L., Hoegberget-Kalisz, M., Svensson, R. B., Hjortshoej, M. H., Olesen, J. L., Nybing, J. D., Boesen, M., Magnusson, S. P. & Kjaer, M., aug. 2021, I: The American journal of sports medicine. 49, 10, s. 2783-2794 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Muscle strain injury leads to a high risk of recurrent injury in sports and can cause long-term symptoms such as weakness and pain. Scar tissue formation after strain injuries has been described, yet what ultrastructural changes might occur in the chronic phase of this injury have not. It is also unknown if persistent symptoms and morphological abnormalities of the tissue can be mitigated by strength training.

PURPOSE: To investigate if heavy resistance training improves symptoms and structural abnormalities after strain injuries.

STUDY DESIGN: Randomized controlled trial; Level of evidence, 1.

METHODS: A total of 30 participants with long-term weakness and/or pain after a strain injury of the thigh or calf muscles were randomized to eccentric heavy resistance training of the injured region or control exercises of the back and abdominal muscle. Isokinetic (hamstring) or isometric (calf) muscle strength was determined, muscle cross-sectional area measured, and pain and function evaluated. Scar tissue ultrastructure was determined from biopsy specimens taken from the injured area before and after the training intervention.

RESULTS: Heavy resistance training over 3 months improved pain and function, normalized muscle strength deficits, and increased muscle cross-sectional area in the previously injured region. No systematic effect of training was found upon pathologic infiltration of fat and blood vessels into the previously injured area. Control exercises had no effect on strength, cross-sectional area, or scar tissue but a positive effect on patient-related outcome measures, such as pain and functional scores.

CONCLUSION: Short-term strength training can improve sequelae symptoms and optimize muscle function even many years after a strain injury, but it does not seem to influence the overall structural abnormalities of the area with scar tissue.

REGISTRATION: NCT02152098 (ClinicalTrials.gov identifier).

Originalsprog Engelsk
Tidsskrift The American journal of sports medicine
Vol/bind 49
Udgave nummer 10
Sider (fra-til) 2783-2794
Antal sider 12
ISSN 0363-5465
DOI
Status Udgivet - aug. 2021

OBJECTIVES: To explore the prognostic value of pre-specified comorbidities on treatment outcomes in PsA, and to compare baseline data with cutaneous psoriasis without arthritis and healthy controls (HC).

METHODS: Patients initiating conventional synthetic/biological disease-modifying antirheumatic drugs were enrolled in this clinical observational cohort study, and data on comorbidities, and clinical and patient-reported outcomes were retrieved at baseline and after 4 months. Pearson's chi-squared tests were performed to investigate the prognostic value of pre-specified comorbidities and achievement of ACR20, DAPSA50 and MDA. Mann-Whitney U tests were used to compare OMERACT PsA Core Outcome Set (COS) measures at baseline and follow-up for the pre-specified comorbidities.

RESULTS: A total of 100 PsA patients were included at baseline. Statistically significantly fewer patients with obesity achieved DAPSA50 compared with patients without obesity (P =0.035), and fewer patients with hypertension (P =0.034) and Charlson Comorbidity Index (CCI) ≥1 (P =0.027), respectively, achieved MDA compared with patients without these comorbidities. Patients with obesity, hypertension, widespread pain, and CCI ≥1 had significantly worse COS measures at follow-up compared with patients without these comorbidities. At baseline, patients with PsA had higher disease burden compared with patients with cutaneous psoriasis and HC, including higher pain (P <0.001) and fatigue (P <0.001) scores, and more widespread pain (P =0.002).

CONCLUSION: Obesity, hypertension and CCI ≥1 were prognostic factors for poorer treatment outcome rates in PsA. Pain and fatigue were more frequently reported among patients with PsA compared with patients with cutaneous psoriasis and HC.

TRIAL REGISTRATION: The Danish National Committee on Health Research Ethics: H-15009080; Data Protection Agency: 2012-58-0004; ClinicalTrials.gov: NCT02572700.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 7
Sider (fra-til) 3289-3300
Antal sider 12
ISSN 1462-0324
DOI
Status Udgivet - 1 jul. 2021

Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial

Nabi, H., Georgiadis, S., Loft, A. G., Hendricks, O., Jensen, D. V., Andersen, M., Chrysidis, S., Colic, A., Danebod, K., Hussein, M. R., Kalisz, M. H., Kristensen, S., Lomborg, N., Manilo, N., Munk, H. L., Pedersen, J. K., Raun, J. L., Mehnert, F., Krogh, N. S., Hetland, M. L. & Glintborg, B., nov. 2021, I: Annals of the Rheumatic Diseases. 80, 11, s. 1400-1409 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA).

METHODS: Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication).

RESULTS: Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched.

CONCLUSION: This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 80
Udgave nummer 11
Sider (fra-til) 1400-1409
Antal sider 10
ISSN 0003-4967
DOI
Status Udgivet - nov. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Comparison of treatment retention and response to secukinumab versus tumour necrosis factor inhibitors in psoriatic arthritis

Lindström, U., Glintborg, B., Di Giuseppe, D., Schjødt Jørgensen, T., Gudbjornsson, B., Lederballe Grøn, K., Aarrestad Provan, S., Michelsen, B., Lund Hetland, M., Wallman, J. K., Nordström, D., Trokovic, N., Love, T. J., Krogh, N. S., Askling, J., Jacobsson, L. T. H. & Kristensen, L. E., 2 aug. 2021, I: Rheumatology (Oxford, England). 60, 8, s. 3635-3645 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To compare treatment retention and response to secukinumab vs adalimumab, including the other four TNF inhibitors (TNFi) as comparators, in PsA.

METHODS: All patients with PsA starting secukinumab or a TNFi in 2015-2018 were identified in the biologic registers of the Nordic countries. Data on comorbidities were linked from national registers. One-year treatment retention and hazard ratios (HRs) for treatment discontinuation were calculated. The proportion achieving a 6 month 28-joint Disease Activity Index for Psoriatic Arthritis (DAPSA28) remission was determined together with odds ratios (ORs) for remission (logistic regression). Both HRs and ORs were calculated with adalimumab as the reference and adjusted for baseline characteristics and concurrent comorbidities. All analyses were stratified by the line of biologic treatment (first, second, third+).

RESULTS: We identified 6143 patients contributing 8307 treatment courses (secukinumab, 1227; adalimumab, 1367). Secukinumab was rarely used as the first biologic, otherwise baseline characteristics were similar. No clinically significant differences in treatment retention or response rates were observed for secukinumab vs adalimumab. The adjusted HRs for discontinuation per the first, second and third line of treatment were 0.98 (95% CI 0.68, 1.41), 0.94 (0.70, 1.26) and 1.07 (0.84, 1.36), respectively. The ORs for DAPSA28 remission in the first, second and third line of treatment were 0.62 (95% CI 0.30, 1.28), 0.85 (0.41, 1.78) and 0.74 (0.36, 1.51), respectively. In the subset of patients previously failing a TNFi due to ineffectiveness, the results were similar.

CONCLUSION: No significant differences in treatment retention or response were observed between secukinumab and adalimumab, regardless of the line of treatment. This suggests that even in patients who have failed a TNFi, choosing either another TNFi or secukinumab may be equally effective.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 8
Sider (fra-til) 3635-3645
Antal sider 11
ISSN 1462-0324
DOI
Status Udgivet - 2 aug. 2021

Concurrent Validity Between Electronically Administered Physical Activity Questionnaires and Objectively Measured Physical Activity in Danish Community-Dwelling Older Adults

Larsen, R. T., Korfitsen, C. B., Juhl, C. B., Boje Andersen, H., Langberg, H. & Christensen, J., aug. 2021, I: Journal of Aging and Physical Activity. 29, 4, s. 595-603 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

AIM: To investigate the concurrent validity of the International Physical Activity Questionnaire-short form (IPAQ-SF) and the Nordic Physical Activity Questionnaire-short (NPAQ-short) when compared with objectively measured daily steps among older adults.

METHODS: Spearman's ρ between IPAQ-SF and NPAQ-short and objectively measured steps using Garmin Vivofit 3 physical activity monitors.

RESULTS: A total of 54 participants were included. The IPAQ-SF subscales' moderate physical activity (PA), moderate to vigorous PA (MVPA), and sedentary time showed little or no correlation with daily steps. The NPAQ-short subscales' vigorous PA, moderate PA, and MVPA showed little or no correlation. The IPAQ-SF subscales' vigorous PA and walking showed fair correlation. Only the IPAQ-SF metabolic equivalent of task minutes showed moderate to good correlation with daily steps. The IPAQ-SF categories and NPAQ-short categorization of World Health Organization compliance were significantly different, but the magnitudes were small and distributions indicated problems with the categorization.

CONCLUSION: The concurrent validity is low, as the scores did not reflect objectively measured daily steps.

Originalsprog Engelsk
Tidsskrift Journal of Aging and Physical Activity
Vol/bind 29
Udgave nummer 4
Sider (fra-til) 595-603
Antal sider 9
ISSN 1063-8652
DOI
Status Udgivet - aug. 2021

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial

Karlsen, R. V., Bidstrup, P. E., Giraldi, A., Hvarness, H., Bagi, P., Lauridsen, S. V., Albieri, V., Frederiksen, M., Krause, E., Due, U. & Johansen, C., 3 jun. 2021, I: Sexual Medicine. 9, 3, s. 100350

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function.

AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP.

METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention.

MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners.

RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months.

CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

Originalsprog Engelsk
Tidsskrift Sexual Medicine
Vol/bind 9
Udgave nummer 3
Sider (fra-til) 100350
ISSN 2050-1161
DOI
Status Udgivet - 3 jun. 2021

OBJECTIVE: To summarize the literature on trans-arterial embolization in inflammatory musculoskeletal conditions, focusing on efficacy and safety.

MATERIALS AND METHODS: PRISMA guidelines were followed. A systematic literature search revealed 19 studies, with a total of 394 participants, eligible for inclusion.

RESULTS: The included studies consisted of case reports/series and non-randomized interventional studies, with knee osteoarthritis and adhesive capsulitis of the shoulder as the most frequent conditions. In all studies except one, pain was reduced up to four years after treatment. All adverse events were transient. Due to high heterogeneity, meta-analysis was not possible.

CONCLUSION: The included early studies showed encouraging results regarding efficacy and safety. However, randomized, placebo-controlled trials are warranted.

Originalsprog Engelsk
Tidsskrift Cardiovascular and Interventional Radiology
ISSN 0174-1551
DOI
Status E-pub ahead of print - 2 sep. 2021

Danish translation, cultural adaptation and initial validation of the Self-Assessment of modes questionnaire (D-SAMQ)

Sampedro Pilegaard, M., Sithamparanathan, T., Nielsen, K. T., Taylor, R. & Waehrens, E. E., maj 2021, I: Scandinavian Journal of Occupational Therapy. 28, 4, s. 285-293 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The Self-Assessment of Modes Questionnaire (SAMQ) was developed for occupational therapists (OTs) to identify their therapeutic style when interacting with clients. To provide Danish Occupational Therapists (OTs) with access to the SAMQ, a rigorous translation, cultural adaptation and validation are required.

AIM: To describe the process of translating and culturally adapting the SAMQ into Danish (D-SAMQ) and examining initial validation of the SAMQ in terms of relevance and comprehensiveness in a Danish context.

MATERIAL AND METHODS: A 10-step process for translation and cultural adaptation was followed: (1) Preparation, (2) Forward translation, (3) Reconciliation, (4) Back translation, (5) Back-translation review, (6) Harmonization, (7) Cognitive debriefing, (8) Review of cognitive debriefing results and finalization, (9) Proofreading and (10) Final report. The cognitive debriefing also involved validation.

RESULTS: Seven OTs and one OT student were included in the cognitive debriefing. Adaptations were made in eight of twenty cases, and modifications regarding the choice of words, sentence structure, and rephrasing were performed. The participants suggested more contextual details in the case descriptions.

CONCLUSION: The SAMQ was translated into Danish (D-SAMQ) and adapted and validated by Danish OTs. The D-SAMQ may enable OTs to identify their therapeutic style, and thereby improve the client-therapist relationship.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
Vol/bind 28
Udgave nummer 4
Sider (fra-til) 285-293
Antal sider 9
ISSN 1103-8128
DOI
Status Udgivet - maj 2021

Determining a healthy reference range and factors potentially influencing PRO-C3 - A biomarker of liver fibrosis

Erhardtsen, E., Rasmussen, D. G. K., Frederiksen, P., Leeming, D. J., Shevell, D., Gluud, L. L., Karsdal, M. A., Aithal, G. P. & Schattenberg, J. M., aug. 2021, I: JHEP reports : innovation in hepatology. 3, 4, 100317.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background & Aims: Progressive fibrosis has been identified as the major predictor of mortality in patients with non-alcoholic fatty liver disease (NAFLD). Several biomarkers are currently being evaluated for their ability to substitute the liver biopsy as the reference standard. Recent clinical studies in NAFLD/NASH patients support the utility of PRO-C3, a marker of type III collagen formation, as a marker for the degree of fibrosis, disease activity, and effect of treatment. Here we establish the healthy reference range, optimal sample handling conditions for both short- and long-term serum storage, and robustness for the PRO-C3 assay.

Methods: PRO-C3 was measured in 269 healthy volunteers and in 222 NAFLD patients. Robustness of the PRO-C3 assay was measured according to Clinical and Laboratory Standards Institute standards and included validation of interference, precision, and reagent stability, whilst sample stability was defined for storage at different temperatures and for 3 freeze-thaw cycles. Fibrosis scoring was based on histological assessments and used as a reference for the diagnostic ability of PRO-C3 to discriminate between patients with different levels of fibrosis.

Results: Robustness of the PRO-C3 analysis validated by interference, precision, and reagent stability was found to be within the predefined acceptance criteria. The healthy reference range was determined to be 6.1-14.7 ng/ml. Levels of PRO-C3 were not affected by sex, age, BMI, or ethnicity. Levels of PRO-C3 were able to identify patients with clinically significant fibrosis and advanced fibrosis (AUC = 0.83 (95% CI [0.77-0.88], p <0.0001), and AUC = 0.79 (95% CI [0.73-0.85], p <0.0001), respectively).

Conclusions: The assay proved to be robust and sample stability was found to comply with hospital sample handling requirements. PRO-C3 measured in samples from patients with NAFLD/NASH was diagnostic for significant and advanced liver fibrosis.

Lay summary: We showed that PRO-C3 levels were stable under conditions conforming with hospital sample-handling requirements. We determined a healthy reference range and showed that PRO-C3 levels were not associated with sex, age, BMI, or ethnicity. Finally, we provide further evidence of an association of PRO-C3 with increasing liver fibrosis.

Originalsprog Engelsk
Artikelnummer 100317
Tidsskrift JHEP reports : innovation in hepatology
Vol/bind 3
Udgave nummer 4
ISSN 2589-5559
DOI
Status Udgivet - aug. 2021

Developing a composite outcome tool to measure response to treatment in ANCA-associated vasculitis: A mixed methods study from OMERACT 2020

Quinn, K. A., Monti, S., Christensen, R., Jayne, D., Langford, C. A., Lanier, G. E., Mahr, A., Pagnoux, C., Shea, B., Tugwell, P., Viðarsdóttir, M. B., Tomasson, G. & Merkel, P. A., okt. 2021, I: Seminars in Arthritis and Rheumatism. 51, 5, s. 1134-1138 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group aims to develop composite response criteria for ANCA-Associated Vasculitis (AAV).

METHODS: The project follows the OMERACT approach for composite measures: (i) choose relevant domains; (ii) define high-quality instruments; (iii) decide on a scoring system approach; (iv) put through the OMERACT Filter 2.1 for validation.

RESULTS: A systematic literature review of outcome measures used in clinical trials in AAV and an international Delphi exercise among patients with AAV and clinician-investigators with expertise in AAV have been completed to inform the candidate domains/instruments for the composite response criteria, which are the first two steps in the OMERACT approach for developing composite measures. Results of the systematic literature review and Delphi were presented at the OMERACT 2020 virtual workshop, and feedback was received on the next steps of the project, including the development of a scoring system approach.

CONCLUSION: The ultimate goal of this project is to develop validated composite response criteria for use in clinical trials of AAV.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 5
Sider (fra-til) 1134-1138
Antal sider 5
ISSN 0049-0172
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Published by Elsevier Inc.

Development and cross-cultural validation of the Goal Content for Weight Maintenance Scale (GCWMS)

Encantado, J., Marques, M. M., Palmeira, A. L., Sebire, S. J., Teixeira, P. J., Stubbs, R. J., Heitmann, B. L. & Gouveia, M. J., dec. 2021, I: Eating and Weight Disorders. 26, 8, s. 2737-2748 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: Long-term weight management requires sustained engagement with energy-balance-related behaviours. According to self-determination theory, behaviour goals can support or undermine motivation depending on the quality of their content (i.e., extrinsic and intrinsic motivation). This study aimed to develop and validate the goal content for weight loss maintenance scale (GCWMS).

METHODS: The GCWMS was administered to 1511 participants who had achieved clinically significant weight losses and were taking part in a large weight loss maintenance study: the NoHoW Trial (ISRCTN88405328). The scale derived from two well-established questionnaires regarding exercise goals. Construct validity was examined for 4 theory-driven domains: Health Management, Challenge, Image, and Social Recognition. Split-sample confirmatory factor analysis was conducted to test the factorial validity and multi-group measurement invariance (configural, metric, scalar, and residual invariance). The reliability estimates were also assessed, and discriminant validity was evaluated using 2 conceptually related questionnaires.

RESULTS: The first analysis showed a poor fit of the original factorial structure. Subsequent investigation with a new specified model indicated close fit to the data after removal of 3 items χ2(58) = 599.982; p < .001; χ2/df = 10.345; CFI = 0.940; GFI = 0.941; SRMR = 0.063; RMSEA = 0.079 (LL = 0.073; UL = .084). Good internal consistency was achieved in all subscales (α > .775), convergent and divergent validity were verified through associations with other theoretical related constructs. Findings from multi-group invariance test demonstrated that the specified model of GCWMS achieved full measurement invariance for gender but did not support residual invariance across countries.

CONCLUSION: Findings support the hypothesised four-dimension structure of the GCWMS, confirming reliability and multi-group invariance in factor structure. Analysis also supports valid group means comparisons on latent factors at gender and at cross-cultural level. Ways to improve the quality of the scale are discussed.

LEVEL OF EVIDENCE: Level V, cross-sectional descriptive.

Originalsprog Engelsk
Tidsskrift Eating and Weight Disorders
Vol/bind 26
Udgave nummer 8
Sider (fra-til) 2737-2748
Antal sider 12
ISSN 1124-4909
DOI
Status Udgivet - dec. 2021

Bibliografisk note

© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.

OBJECTIVE: In axial spondyloarthritis (axSpA), sacroiliac joint (SIJ) erosion is often followed by fat metaplasia in an erosion cavity (backfill), and subsequently ankylosis. We aimed to combine the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score for erosion, backfill, and ankylosis into 3 versions of a novel preliminary axSpA magnetic resonance imaging (MRI) SIJ Composite Structural Damage Score (CSDS) and to test these.

METHODS: Thirty-three patients with axSpA, followed for 5 years after initiation of tumor necrosis factor inhibitor, had MRIs of the SIJs at baseline, and yearly thereafter. Three versions of CSDS were calculated based on different weightings of erosion, backfill, and ankylosis: (1) equal weighting: CSDSequal = (erosion × 0.5) + backfill + ankylosis; (2) advanced stages weighting more: CSDSstepwise = (erosion × 1) + (backfill × 4) + (ankylosis × 6); and (3) advanced stages overruling earlier stages ("hierarchical") with "<" meaning "overruled by": CSDShierarchical = (erosion × 1) < (backfill × 4) < (ankylosis × 6).

RESULTS: At baseline, all CSDS correlated positively with SPARCC fat and ankylosis scores and modified New York radiography grading, and negatively with the Bath Ankylosing Spondylitis Disease Index and SPARCC SIJ inflammation scores. CSDSstepwise and CSDShierarchical (not CSDSequal) correlated positively with symptom duration and the Bath Ankylosing Spondylitis Metrology Index, and closer with SPARCC ankylosis score and modified New York radiography grading than CSDSequal. The adjusted annual progression rate for CSDSstepwise and CSDShierarchical (not CSDSequal) was higher the first year compared with fourth year (P = 0.04 and P = 0.01). Standardized response mean (baseline to Week 46) was moderate for CSDShierarchical (0.64) and CSDSstepwise (0.59) and small for CSDSequal (0.25).

CONCLUSION: Particularly CSDSstepwise and CSDShierarchical showed construct validity and responsiveness, encouraging further validation in larger clinical trials. The potential clinical implication is assessment of SIJ damage progression by 1 composite score.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 48
Udgave nummer 10
Sider (fra-til) 1537-1546
Antal sider 10
ISSN 0315-162X
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 by the Journal of Rheumatology.

Development of a patient-centered core domain set for prospective observational longitudinal outcome studies in rheumatoid arthritis: an OMERACT initiative

Bruera, S., Carmona, L., Lopez-Olivo, M. A., Westrich-Robertson, T., March, L., Negron, J. B., Christensen, R., Strand, V., Ingegnoli, F., Goel, N., Shea, B., Tugwell, P., Leong, A., Bingham, C. O., Hill, C. L. & Suarez-Almazor, M. E., okt. 2021, I: Seminars in Arthritis and Rheumatism. 51, 5, s. 1113-1116 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis.

METHODS: Our working group held a virtual meeting in November 2020 to review data from a literature review and patient qualitative interviews, and to discuss strategies to move forward on domain identification and selection using the OMERACT 2.1 domain selection process.

RESULTS: Important candidate domains and subdomains were identified including in the areas of life impact. Consensus was reached on moving forward with a Delphi process.

CONCLUSIONS: The meeting provided future directions to identify and select a core set of domains for use in LOS.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 5
Sider (fra-til) 1113-1116
Antal sider 4
ISSN 0049-0172
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

Dietary trans-fatty acid intake in relation to cancer risk: a systematic review and meta-analysis

Michels, N., Specht, I. O., Heitmann, B. L., Chajès, V. & Huybrechts, I., 4 jun. 2021, I: Nutrition Reviews. 79, 7, s. 758-776 19 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

CONTEXT: Apart from ruminant fat, trans-fatty acids are produced during the partial hydrogenation of vegetable oils, (eg, in the production of ultraprocessed foods). Harmful cardiovascular effects of trans-fatty acids are already proven, but the link with cancer risk has not yet been summarized.

OBJECTIVE: A systematic review (following PRISMA guidelines) - including observational studies on the association of trans-fatty acid intake with any cancer risk - was conducted, with no limitations on population types.

DATA SOURCES: The electronic databases PubMed and Embase were searched to identify relevant studies.

DATA EXTRACTION: This systematic review included 46 articles. Quality was assessed via the Newcastle-Ottawa scale. Meta-analyses were conducted if at least 4 articles exploring the same transfat-cancer pairings were found.

DATA ANALYSIS: Nineteen cancer types have been researched in cohort and case-control studies on trans-fatty acids, with breast cancer (n = 17), prostate cancer (n = 11), and colorectal cancer (n = 9) as the most researched. The meta-analyses on total trans-fat showed a significant positive association for prostate cancer (odds ratio [OR] 1.49; 95%CI, 1.13-1.95) and colorectal cancer (OR 1.26; 95%CI, 1.08-1.46) but not for breast cancer (OR 1.12; 95%CI, 0.99-1.26), ovarian cancer (OR 1.10; 95%CI, 0.94-1.28), or non-Hodgkin lymphoma (OR 1.32; 95%CI, 0.99-1.76). Results were dependent on the fatty acid subtype, with even cancer-protective associations for some partially hydrogenated vegetable oils. Enhancing moderators in the positive transfat-cancer relation were gender (direction was cancer-site specific), European ancestry, menopause, older age, and overweight.

CONCLUSION: Despite heterogeneity, higher risk of prostate and colorectal cancer by high consumption of trans-fatty acids was found. Future studies need methodological improvements (eg, using long-term follow-up cancer data and intake biomarkers). Owing to the lack of studies testing trans-fatty acid subtypes in standardized ways, it is not clear which subtypes (eg, ruminant sources) are more carcinogenic.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42018105899.

Originalsprog Engelsk
Tidsskrift Nutrition Reviews
Vol/bind 79
Udgave nummer 7
Sider (fra-til) 758-776
Antal sider 19
ISSN 0029-6643
DOI
Status Udgivet - 4 jun. 2021

BACKGROUND: Patients with psoriasis have an impaired quality of life and higher use of analgesics than the general population. Whether such use is due to skin pain or a consequence of joint pain resulting from psoriatic arthritis (PsA) is not clear.

OBJECTIVES: To assess symptoms, disease burden, and use of analgesics in patients with psoriasis with and without PsA.

METHOD: Symptoms, general health (EurQol 5-dimension and 5-levels), and use of analgesics were assessed in patients with psoriasis and the general population from the Danish Skin Cohort.

RESULTS: We included 4016 patients with psoriasis (847 with concomitant PsA) and 3490 reference individuals. For patients with psoriasis having PsA, itch, skin pain, and/or joint pain was associated with worse general health. Use of opioids within 12 months was observed among 9.0% of the general population, 14.2% of patients with psoriasis without PsA, and 22.7% of patients with concomitant PsA. Of the symptoms, only joint pain was associated with use of analgesics (odds ratio, 3.72 (2.69-5.14); P < .0001).

LIMITATIONS: Cross-sectional design.

CONCLUSION: Patients with psoriasis (especially concomitant PsA) have a higher use of analgesics compared with the general population, which appears to be a result of increased joint pain.

Originalsprog Engelsk
Tidsskrift Journal of the American Academy of Dermatology
ISSN 0190-9622
DOI
Status Accepteret/In press - 2021

Bibliografisk note

Funding Information:
Dr Loft has been an honorary speaker for Eli Lilly and Janssen Cilag. Dr. Nguyen reports no potential conflicts of interest. Dr Kristensen has received fees for as a speaker and consultant for Pfizer, AbbVie, Amgen, Forward pharma, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals. Dr Thyssen reports no relevant conflicts of interest. Dr Egeberg has received research funding from Pfizer, Eli Lilly , Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation , the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation , and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Sun Pharmaceuticals, Galapagos NV, Samsung Bioepis Co, Ltd., Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb, and Janssen Pharmaceuticals.

Funding Information:
Dr Loft has been an honorary speaker for Eli Lilly and Janssen Cilag. Dr. Nguyen reports no potential conflicts of interest. Dr Kristensen has received fees for as a speaker and consultant for Pfizer, AbbVie, Amgen, Forward pharma, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals. Dr Thyssen reports no relevant conflicts of interest. Dr Egeberg has received research funding from Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Sun Pharmaceuticals, Galapagos NV, Samsung Bioepis Co, Ltd., Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb, and Janssen Pharmaceuticals. Funding sources: None.

Publisher Copyright:
© 2021 American Academy of Dermatology, Inc.

OBJECTIVE: To assess the ability of ultrasound to predict successful tapering and successful discontinuation of biological DMARDs (bDMARDs) at the 2-year follow-up in RA patients in sustained remission.

METHODS: Patients in sustained remission (DAS28-CRP ≤ 2.6) and with no radiographic progression the previous year tapered bDMARDs according to a standardized regime. A total of 119 of these patients were included in this ultrasound substudy. At baseline, clinical assessment, MRI, X-ray and ultrasound of 24 joints were performed. Ultrasound-detected synovitis was defined and scored 0-3 using the OMERACT scoring system at the joint level for both grey-scale and Doppler activity. Sum scores for each ultrasound modality were calculated for 24 joints at the patient level. The final state of treatment was assessed after 2 years. The predictive value of ultrasound measures for successful tapering and discontinuation at the 2-year follow-up was assessed via logistic regression analyses.

RESULTS: Negative IgM-RF [odds ratio (OR) = 0.29, 95% CI: 0.10-0.85; P = 0.024] and lower Doppler sum score of 24 joints (OR = 0.44, 95% CI: 0.15, 0.87; P = 0.014) were independent predictors for successful discontinuation of bDMARDs at the 2-year follow-up. The predictive value of the Doppler sum score was independent of MRI findings. Previous numbers of bDMARDs were predictive of successful tapering (OR = 0.58, 95% CI: 0.35, 0.91; P = 0.018), whereas ultrasound was not. Clinical parameters were not predictive of successful tapering/discontinuation.

CONCLUSION: Doppler sum score was an independent predictor for successful discontinuation of bDMARDs at the 2-year follow-up-the odds for achieving successful discontinuation decreased by 56% per one-unit increase in Doppler sum score. Ultrasound could not predict successful tapering.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 12
Sider (fra-til) 5549-5559
Antal sider 11
ISSN 1462-0324
DOI
Status Udgivet - 1 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.

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