Published in 2021

Loss of height predicts total and cardiovascular mortality: a cohort study of northern European women

Klingberg, S., Mehlig, K., Dangol, R., Björkelund, C., Heitmann, B. L. & Lissner, L., 9 aug. 2021, I: BMJ Open. 11, 8, s. e049122 e049122.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To examine height changes in middle-aged northern European women in relation to overall and cardiovascular mortality.

DESIGN: Population-based cohort studies with longitudinally measured heights and register-based mortality.

SETTING: Sweden and Denmark.

PARTICIPANTS: Population-based samples of 2406 Swedish and Danish women born on selected years in 1908-1952, recruited to baseline examinations at ages 30-60, and re-examined 10-13 years later.

MAIN OUTCOME MEASURE: Total and cardiovascular disease (CVD) specific mortality during 17-19 years of follow-up after last height measure.

RESULTS: For each 1 cm height loss during 10-13 years, the HR (95% CI) for total mortality was 1.14 (1.05 to 1.23) in Swedish women and 1.21 (1.09 to 1.35) in Danish women, independent of key covariates. Low height and high leisure time physical activity at baseline were protective of height loss, independent of age. Considering total mortality, the HR for major height loss, defined as height loss greater than 2 cm, were 1.74 (1.32 to 2.29) in Swedish women and 1.80 (1.27 to 2.54) in Danish women. Pooled analyses indicated that height loss was monotonically associated with an increased mortality, confirming a significant effect above 2 cm height loss. For cause-specific mortality, major height loss was associated with a HR of 2.31 (1.09 to 4.87) for stroke mortality, 2.14 (1.47 to 3.12) for total CVD mortality and 1.71 (1.28 to 2.29) for mortality due to causes other than CVD.

CONCLUSION: Height loss is a marker for excess mortality in northern European women. Specifically the hazard of CVD mortality is increased in women with height loss during middle age, and the results suggest that the strongest cause-specific endpoint may be stroke mortality. The present findings suggest attention to height loss in early and mid-adulthood to identify women at high risk of CVD, and that regular physical activity may prevent early onset height loss.

Originalsprog Engelsk
Artikelnummer e049122
Tidsskrift BMJ Open
Vol/bind 11
Udgave nummer 8
Sider (fra-til) e049122
ISSN 2044-6055
DOI
Status Udgivet - 9 aug. 2021

Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial

Bruun, K. D., Amris, K., Vaegter, H. B., Blichfeldt-Eckhardt, M. R., Holsgaard-Larsen, A., Christensen, R. & Toft, P., 15 nov. 2021, I: Trials. 22, 1, s. 804 804.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia.

METHODS: A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18-64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers.

DISCUSSION: This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia.

TRIAL REGISTRATION: EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020.

Originalsprog Engelsk
Artikelnummer 804
Tidsskrift Trials
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 804
ISSN 1745-6215
DOI
Status Udgivet - 15 nov. 2021

Bibliografisk note

© 2021. The Author(s).

Lyme arthritis is rare in Eastern Denmark

Müller, T., Locht, H., Panum, I., Nielsen, L. & Jensen, B., 1 nov. 2021, I: Danish Medical Journal. 68, 11, s. 1-7 7 s., A05210423.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION The multi-organ disease Lyme borreliosis can cause mainly large joint arthritis. No guideline exists describing how to diagnose Lyme arthritis (LA). The incidence of LA in Denmark remains unknown, but it is considered to be low. The primary aim of this study was to quantify the number of Borrelia burgdorferi serological tests requested from primary and secondary care; secondly, to examine how often LA is diagnosed. METHODS this was a register-based study including B. burgdorferi serological tests analysed at the department of clinical microbiology at Hvidovre and Herlev Hospitals during a two-year period. The results of the tests were categorised into primary and secondary care. A medical record review was made covering all newly referred rheumatological patients with B. burgdorferi serological tests analysed the Department of Clinical Microbiology, Hvidovre Hospital. A model was set up to diagnose LA. RESULTS Most tests were requested by primary care. A total of 146 rheumatology patients were tested for B. burgdorferi of whom 118 were newly referred. Using our model to diagnose LA, we found that three patients had possible LA, whereas one had likely LA, but none were given a final LA diagnosis. Overdiagnosis was not common among rheumatologists. CONCLUSION. The number of requested B. burgdorferi serological tests was highest in primary care. A clear guideline describing how to diagnose LA is needed in primary and secondary care alike.

Originalsprog Engelsk
Artikelnummer A05210423
Tidsskrift Danish Medical Journal
Vol/bind 68
Udgave nummer 11
Sider (fra-til) 1-7
Antal sider 7
ISSN 1603-9629
Status Udgivet - 1 nov. 2021

Bibliografisk note

Publisher Copyright:
© 2021, Almindelige Danske Laegeforening. All rights reserved.

Human health effects of airborne lower-chlorinated polychlorinated biphenyls (LC-PCBs) are largely unexplored. Since PCBs may cross the placenta, maternal exposure could potentially have negative consequences for fetal development. We aimed to determine if exposure to airborne PCB during pregnancy was associated with adverse birth outcomes. In this cohort study, exposed women had lived in PCB contaminated apartments at least one year during the 3.6 years before conception or the entire first trimester of pregnancy. The women and their children were followed for birth outcomes in Danish health registers. Logistic regression was performed to estimate odds ratios (OR) for changes in secondary sex ratio, preterm birth, major congenital malformations, cryptorchidism, and being born small for gestational age. We performed linear regression to estimate difference in birth weight among children of exposed and unexposed mothers. All models were adjusted for maternal age, educational level, ethnicity, and calendar time. We identified 885 exposed pregnancies and 3327 unexposed pregnancies. Relative to unexposed women, exposed women had OR 0.97 (95% CI 0.82, 1.15) for secondary sex ratio, OR 1.13 (95% CI 0.76, 1.67) for preterm birth, OR 1.28 (95% CI 0.81, 2.01) for having a child with major malformations, OR 1.73 (95% CI 1.01, 2.95) for cryptorchidism and OR 1.23 (95% CI 0.88, 1.72) for giving birth to a child born small for gestational age. The difference in birth weight for children of exposed compared to unexposed women was - 32 g (95% CI-79, 14). We observed an increased risk of cryptorchidism among boys after maternal airborne LC-PCB exposure, but due to the proxy measure of exposure, inability to perform dose-response analyses, and the lack of comparable literature, larger cohort studies with direct measures of exposure are needed to investigate the safety of airborne LC-PCB exposure during pregnancy.

Originalsprog Engelsk
Tidsskrift European Journal of Epidemiology
Vol/bind 36
Udgave nummer 8
Sider (fra-til) 861-872
Antal sider 12
ISSN 0393-2990
DOI
Status Udgivet - aug. 2021

Bibliografisk note

© 2021. The Author(s).

Measurement properties of radiographic outcome measures in Psoriatic Arthritis: A systematic review from the GRAPPA-OMERACT initiative

Antony, A., Holland, R., D'Agostino, M-A., Maksymowych, W. P., Bertheussen, H., Schick, L., Goel, N., Ogdie, A., Orbai, A-M., Højgaard, P., Coates, L. C., Strand, V., Gladman, D. D., Christensen, R., Leung, Y. Y., Mease, P. & Tillett, W., apr. 2021, I: Seminars in Arthritis and Rheumatism. 51, 2, s. 367-386 20 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

BACKGROUND: Structural damage is as an important outcome in the Psoriatic Arthritis (PsA) Core Domain Set and its assessment is recommended at least once in the development of a new drug.

OBJECTIVES: To conduct a systematic review (SR) to identify studies addressing the measurement properties of radiographic outcome instruments for structural damage in PsA and appraise the evidence through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Framework Instrument Selection Algorithm (OFISA).

METHODS: A SR was conducted using search strategies in EMBASE and MEDLINE to identify full-text English studies which aimed to develop or assess the measurement properties of radiographic outcome instruments in PsA. Determination of eligibility and data extraction was performed independently by two reviewers with input from a third to achieve consensus. Two reviewers assessed the methodology and results of eligible studies and synthesized the evidence using OMERACT methodology.

RESULTS: Twelve articles evaluating radiographic instruments were included. The articles assessed nine peripheral (hands, wrists and/or feet) and six axial (spinal and/or sacroiliac joints) radiographic instruments. The peripheral radiographic instruments with some evidence for reliability, cross-sectional construct validity and longitudinal construct validity were the Ratingen and modified Sharp van der Heijde scores. No instruments had evidence for clinical trial discrimination or thresholds of meaning. There was limited evidence for the measurement properties of all identified axial instruments.

CONCLUSION: There are significant knowledge gaps in the responsiveness of peripheral radiographic instruments. Axial radiographic instruments require further validation, and the need to generate novel instruments and utilise other imaging modalities should be considered.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 2
Sider (fra-til) 367-386
Antal sider 20
ISSN 0049-0172
DOI
Status Udgivet - apr. 2021

Measuring self-reported ability to perform activities of daily living: a Rasch analysis

Wæhrens, E. E., Kottorp, A. & Nielsen, K. T., 18 okt. 2021, I: Health and Quality of Life Outcomes. 19, 1, s. 243 243.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Since the number of persons diagnosed with multi-morbidity is increasing, there is a need for generic instruments to be able to assess, measure and compare ADL ability across diagnoses. Accordingly, the ADL-Interview (ADL-I) was developed to be used in rehabilitation research and clinical practice. The aim of this study was to investigate if the ADL-I can be used to provide valid and reliable ADL ability measures across gender and diagnostic groups. Methods: ADL-I data were extracted from an existing research database on persons with chronic conditions including medical, rheumatological, oncological, neurological, geriatric and psychiatric diagnoses. Data were analysed based on Rasch Measurement methods to examine: the psychometric properties of the rating scale; ADL item and person fit to the Rasch model; if the difficulty of the ADL tasks differs across gender and diagnostic groups, and if the ADL-I provides precise and reliable measures of ADL ability. Results: Data on n = 2098 persons were included in the final analysis. Initial evaluation of the 0–3 rating scale revealed threshold disordering between categories 1 and 2. After removal of 16 underfitting items, the variance explained by the Rasch dimension increased from 54.3 to 58.0%, thresholds were ordered, but the proportion of persons with misfitting ADL-I measures increased slightly from 8.7 to 9.1%. The person separation index improved slightly from 2.75 to 2.99 (reliability = 0.90). Differential test function analysis, however, supported that the 16 underfitting items did not represent a threat to the measurement system. Similarly, ADL items displaying differential item functioning across gender and diagnoses did not represent a threat to the measurement system. The ADL items and participants were well distributed along the scale, with item and person measures well targeted to each other, indicating a small ceiling effect and no floor effect. Conclusions: The study results overall suggest that the ADL-I is producing valid and reliable measures across gender and diagnostic groups among persons within a broad range of ADL ability, providing evidence to support generic use of the ADL-I. Trial registration: N/A.

Originalsprog Engelsk
Artikelnummer 243
Tidsskrift Health and Quality of Life Outcomes
Vol/bind 19
Udgave nummer 1
Sider (fra-til) 243
ISSN 1477-7525
DOI
Status Udgivet - 18 okt. 2021

Bibliografisk note

Funding Information:
This work was supported by the Danish Association of Occupational Therapists [PP2 – R70- A1509] and The Oak Foundation [OCAY-18-774-OFIL].

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

Musculoskeletal function in anterior cruciate ligament reconstructed individuals with and without knee pain

Bandak, E., Stenroth, L., Henriksen, M., Bliddal, H., Krommes, K., Hölmich, P. & Alkjær, T., nov. 2021.

Publikation: KonferencebidragKonferenceabstrakt til konferenceForskning

Objective To compare the musculoskeletal function between anterior cruciate ligament (ACL) reconstructed individuals with and without knee pain to better understand the role of the musculoskeletal function in relation to the development of knee osteoarthritis. Study design and methods This is an observational cross-sectional study including individuals with ACL reconstruction in one knee with pain (Symptomatic, n= 50), and without knee pain (Asymptomatic, n= 50). Asymptomatic is defined as pain rating = 0 and Symptomatic ≥3 on a verbal rating scale (VRS; 0-10, higher is worse) in the reconstructed knee during activities of daily living within the last week. The main inclusion criteria consist of age between 18 to 40 years at the time of surgery, post-surgery time ≥3 years, and body mass index ≤30. The main exclusion criteria are major surgery to the other knee, musculoskeletal pain in the lower extremity other than in the ACL reconstructed knee. The primary outcome is maximal isometric quadriceps muscle strength. Secondary outcomes are knee joint biomechanics during walking/forward lunging, maximal isometric hamstring muscle strength, knee pain, pressure pain sensitivity, self-reported knee function, activity level, and radiographic knee osteoarthritis level. The statistical analysis will include a comparison between the two groups (ANCOVA).
Originalsprog Engelsk
Publikationsdato nov. 2021
Status Udgivet - nov. 2021
Begivenhed Annual Symposium: Basic and Clinical Research in Musculo-skeletal Sciences (MUSKOS) - Comwell Borupgaard, Snekkersten, Danmark
Varighed: 25 nov. 2021 → …

Seminar

Seminar Annual Symposium: Basic and Clinical Research in Musculo-skeletal Sciences (MUSKOS)
Lokation Comwell Borupgaard
Land Danmark
By Snekkersten
Periode 25/11/2021 → …

Night work and incidence of Parkinson's disease in the Danish Nurse Cohort

Jørgensen, J. T., Schernhammer, E., Papantoniou, K., Hansen, J., Westendorp, R. G. J., Stayner, L., Simonsen, M. K. & Andersen, Z. J., 1 jun. 2021, I: Occupational and Environmental Medicine. 78, 6, s. 419-425 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Objectives Evidence on the association between night work and Parkinson's disease (PD) is sparse and conflicting, calling for more definitive studies. Methods We included 20 138 female nurses from the Danish Nurse Cohort without PD who at baseline in 1993 and/or 1999 reported their most common current work schedule (day, evening, night, and rotating (a combination of at least two of these)), including information on lifetime cumulative duration (years) of each shift in a 2009 follow-up survey. We obtained information on PD hospital contacts and PD medication until November 2018 via linkage to the Danish National Patient (inpatient from 1977 and outpatient contacts from 1995 onwards) and Prescription Registers starting in 1995. We defined the incidence of PD as the first-ever hospital contact due to PD, or the first-ever redeemed levodopa prescription, whichever came first. We used Cox regression models to calculate HRs and 95% CIs, adjusting for age, smoking status, coffee consumption and use of hormone replacement therapy. Results We found no significant difference in PD risk among nurses who reported working evening (HR=0.86; 95% CI=0.55 to 1.34), night (HR=1.26; 95% CI=0.79 to 2.02) or rotating shifts (HR=0.83; 95% CI=0.56 to 1.21) at cohort baseline in 1993 or 1999, when compared with permanent day workers. Similarly, persistency of shift work (working the same work schedule for 6+ years) or duration of shift work was not associated with PD risk. Conclusions Overall, there was little evidence for an association between various shift work schedules including night work and PD in this cohort of middle-aged female nurses.

Originalsprog Engelsk
Tidsskrift Occupational and Environmental Medicine
Vol/bind 78
Udgave nummer 6
Sider (fra-til) 419-425
Antal sider 7
ISSN 1351-0711
DOI
Status Udgivet - 1 jun. 2021

Bibliografisk note

Funding Information:
Funding This study was funded by The Danish Working Environment Research Fund (Grant no: 22-2017-03).

Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.

Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood

Zheng, M., Hesketh, K. D., Wu, J. H. Y., Heitmann, B. L., Downing, K. & Campbell, K. J., jul. 2021, I: Pediatric obesity. 16, 7, s. e12766 e12766.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The respective contribution of total, daytime and nighttime sleep duration in childhood obesity remains unclear.

OBJECTIVES: To assess the longitudinal association between developmental trajectories of sleep duration and BMI z-score in early childhood.

METHODS: Data were from the Melbourne INFANT program, a prospective cohort with 4-month-old infants being followed-up until age 60 months (n = 528). Sleep duration (total, daytime, nighttime) and BMI z-score were measured using questionnaire at ages 4, 9, 18, 43 and 60 months. Group-based trajectory modelling was used to describe longitudinal trajectories from ages 4 to 60 months. Multivariable logistic regression was conducted to assess the association between sleep duration and BMI z-score trajectories.

RESULTS: Three nighttime sleep duration trajectory groups were identified: "Long stable" (10.5 to 11.0 hours, 61%), "catchup long" (8.0 to 11.5 hours, 23%) and "short stable" (8.7 to 9.8 hours, 16%) nighttime sleepers. BMI z-score trajectory groups were classified as "low-BMIz" (-1.5 to -0.5 unit, 21%), "mid-BMIz" (-0.5 to 0.5 unit, 58%) and "high-BMIz" (0.8 to 1.4 unit, 21%). With adjustment for child and maternal covariates, both "catchup long" (OR 3.69 95%CI 1.74, 7.92) and "long stable" nighttime sleepers (OR 4.27 95%CI 2.21, 8.25) revealed higher odds of being in the "mid-BMIz" than the "high-BMIz" group. By contrast, total or daytime sleep duration trajectories were not associated with BMI z-score trajectories.

CONCLUSIONS: Longer nighttime, but not total or daytime, sleep duration was associated with lower BMI z-score trajectories in early childhood. Our findings reinforce the importance of nighttime sleep for healthy body-weight development in early childhood.

Originalsprog Engelsk
Artikelnummer e12766
Tidsskrift Pediatric obesity
Vol/bind 16
Udgave nummer 7
Sider (fra-til) e12766
ISSN 1524-6817
DOI
Status Udgivet - jul. 2021

Objectives: Nailfold video capillaroscopy (NVC) and angiographic optical coherence tomography (OCTA) have potential in diagnosing PsA and differentiating it from psoriasis vulgaris (PsO) and hand OA. We aimed to assess the diagnostic properties of NVC and OCTA in patients with PsA compared with patients with PsO and hand OA based on nailfold capillary patterns.

Methods: Patients with DIP joint PsA and nail involvement (n = 50), PsO with nail involvement (n = 12) and OA (n = 13) were included in this cross-sectional study. Capillaries were evaluated semi-quantitatively and qualitatively. Differences in capillary findings between groups were assessed using mixed linear models. Binary logistic regression analyses were performed to determine the probability for PsA diagnosis based on capillaroscopy findings.

Results: Below mean capillary density and reduced nailfold blood flow in OCTA images distinguished PsA from both PsO (P = 0.004 and P = 0.052, respectively) and OA (P = 0.024 and P < 0.001, respectively). Qualitative analysis revealed that glomerular capillaries were found in only 3% of PsA patients but in 13% of PsO patients (P = 0.003). Furthermore, crossed vessels were seen in only 55% of PsA patients and 71% of PsO patients (P = 0.043). NVC microhaemorrhage was dominant in PsA patients (13%) and significantly different from OA patients (P <0.05). No capillary pattern was associated with an increased probability of the PsA diagnosis.

Conclusion: A pathognomonic pattern for PsA diagnosis was not identified; however, we demonstrated some characteristic capillaroscopy findings for PsA, such as decreased capillary density, reduced blood flow and fewer crossed vessels in OCTA and presence of NVC microhaemorrhages.

Originalsprog Engelsk
Artikelnummer rkab065
Tidsskrift Rheumatology Advances in Practice
Vol/bind 5
Udgave nummer 3
Sider (fra-til) rkab065
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.

Novel quantitative digital image analysis methodology for assessment of inflammatory changes in MRI data in a post-hoc analysis of data acquired from a phase IIb study of baricitinib in patients with active rheumatoid arthritis

Boesen, M., Beattie, S. D., Schlichting, D. E. & Kubassova, O., okt. 2021, I: European Journal of Radiology. 143, s. 109877 109877.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Purpose: To evaluate a novel quantitative methodology to assess inflammatory changes in magnetic resonance imaging (MRI) data from patients with rheumatoid arthritis (RA) and the impact of image quality on imaging outcomes compared to the RA Magnetic Resonance Imaging Score (RAMRIS). Methods: Three-dimensional, T1-weighted, fat-suppressed MRI sequences of the hand/wrist before and after intravenous Gadolinium contrast from patients with RA in a placebo-controlled clinical trial (NCT01185353) were re-evaluated post hoc. The methodology was integrated into proprietary software (DYNAMIKA®) and assessed inflammation through pixelated measurements of the contrast-enhancing (inflammatory) volume. A semi-automatic approach outlined contrast-enhancing synovial tissue in the wrist and second to fifth metacarpophalangeal joints with a rough region of interest (ROI); quantitative imaging biomarkers were generated by means of quantitative total volume of inflammation and quantitative degree of inflammation relative to the signal in a 1 cm in diameter ROI in the center of the thenar or lumbrical muscle for internal reference. The time from Gadolinium injection to finalization of the post-contrast images was calculated from the images’ Digital Imaging and Communications in Medicine header. An experienced reader graded image quality as poor, acceptable, or good. Results: Results from this quantitative methodology, especially when excluding images with poor quality scores (14–32%), provided a more pronounced and monotonically increasing dose-response than the original RAMRIS results on synovitis and osteitis. Conclusions: This computer-aided quantitative scoring method provided continuous measures of inflammatory changes relative to muscle and may be more sensitive and interpretable concerning dose/response separation between RA treatment groups.

Originalsprog Engelsk
Artikelnummer 109877
Tidsskrift European Journal of Radiology
Vol/bind 143
Sider (fra-til) 109877
ISSN 0720-048X
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Funding Information:
Medical writing support was provided by Shannon E. Gardell of Evidera | PPD and funded by Eli Lilly and Company.

Funding Information:
Medical writing support was provided by Shannon E. Gardell of Evidera | PPD and funded by Eli Lilly and Company. Funding for this study was provided by Eli Lilly and Company, which was involved in the study design, data collection, data analysis, and preparation of the manuscript. Eli Lilly provides access to all individual participant data collected during the trial, after anonymization, except for pharmacokinetic or genetic data. Data are available upon request six months after the indication studied has been approved in the United States and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided atwww.vivli.org.

Publisher Copyright:
© 2021 Eli Lilly and Company

Nursing Implication of People Treated by Radical Cystectomy Postsurgery and Rehabilitation

Lauridsen, S. V., feb. 2021, I: Seminars in Oncology Nursing. 37, 1, 151110.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: The purpose of this paper is to summarize existing evidence about nursing interventions to selected symptoms experienced by patients undergoing radical cystectomy (RC) to maintain or return to their daily life activities.

DATA SOURCES: A non-systematic narrative review was conducted. A search in PubMed and CINAHL was conducted eliciting evidence about frequent symptoms experienced after RC. The following search terms were used: radical cystectomy and/or nursing interventions, pain, distress, fatigue, urinary dysfunction, sexual dysfunction, loss of appetite, sleep disturbance, and enhanced recovery after surgery (ERAS).

CONCLUSION: Evidence in the ERAS pathway is still lacking regarding the effect of preoperative education and counseling of the patient and the most difficult part to implement is related to preoperative optimization of the patient such as lifestyle changes. Most nursing interventions to alleviate symptoms in the rehabilitation period after RC are still practice based.

IMPLICATIONS FOR NURSING PRACTICE: Priority should be given to implementation of the ERAS protocol. To improve the management of symptoms experienced by patients in the RC rehabilitation period it is essential that validated screening tools to identify the symptoms be used. Accepted and effective strategies for treating the individual symptoms should be initiated and clear treatment outcomes should be defined. Urology nurse researchers should investigate the concept of symptom clusters to clarify whether there are more efficient methods to identify symptoms or symptom clusters and if so would the use of symptom clusters knowledge improve patient care.

Originalsprog Engelsk
Artikelnummer 151110
Tidsskrift Seminars in Oncology Nursing
Vol/bind 37
Udgave nummer 1
ISSN 0749-2081
DOI
Status Udgivet - feb. 2021

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

BACKGROUND: The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated.

METHODS: The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful).

RESULTS: Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3-100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects.

CONCLUSIONS: Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed.

TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

Originalsprog Engelsk
Artikelnummer 122
Tidsskrift Pilot and Feasibility Studies
Vol/bind 7
Udgave nummer 1
Sider (fra-til) 122
ISSN 2055-5784
DOI
Status Udgivet - 11 jun. 2021

Older age, smoking, tooth loss and denture-wearing but neither xerostomia nor salivary gland hypofunction are associated with low intakes of fruit and vegetables in older Danish adults

Pedersen, A. M. L., Dynesen, A. W. & Heitmann, B. L., 17 jul. 2021, I: Journal of Nutritional Science. 10, s. e47

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Xerostomia and salivary gland hypofunction are prevalent conditions in older people and may adversely influence the intake of certain foods, notably fruit and vegetables. Here, we aimed to investigate whether xerostomia and salivary gland hypofunction were associated with a lower intake of fruit and vegetables. The study included 621 community-dwelling adults, mean age 75⋅2 ± 6⋅4 years, 58⋅9 % female, who had participated in the Copenhagen City Heart Study follow-up, and undergone interviews regarding food intake (preceding month), oral and general health (xerostomia, taste alterations, diseases, medication, alcohol consumption and smoking), clinical oral examination and measurements of unstimulated and chewing-stimulated whole saliva flow rates. The average total energy intake (8⋅4 ± 2⋅7 MJ) and protein energy percentage (14⋅8 ± 3⋅1 %) were slightly below recommendations. The average fruit (234⋅7 ± 201⋅2 g/d) and vegetables (317⋅3 ± 157⋅4 g/d) intakes were within recommendations. Xerostomia and hyposalivation were more prevalent in women than in men (16⋅4 v. 7⋅1 %, P < 0⋅001 and 40⋅7 v. 27⋅5 %, P < 0⋅001). Multiple linear regression analyses revealed that older age (β -0⋅009, se 0⋅003, P = 0⋅005), smoking (β -0⋅212, se 0⋅060, P = 0⋅0005) and wearing complete dentures/being partially or fully edentulous (β -0⋅141, se 0⋅048, P = 0⋅003), but neither xerostomia nor salivary flow rates were associated with an inadequate fruit and vegetable intake, after adjustment for covariates. Older age, smoking, tooth loss and denture-wearing were stronger determinants of low fruit and vegetable intakes than xerostomia and salivary hypofunction supporting the importance of dietary counselling and maintenance of oral health and an adequate masticatory performance.

Originalsprog Engelsk
Tidsskrift Journal of Nutritional Science
Vol/bind 10
Sider (fra-til) e47
ISSN 0029-6651
DOI
Status Udgivet - 17 jul. 2021

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Nielsen, S. M., Boers, M., de Wit, M., Shea, B., van der Windt, D. A., Reeves, B. C., Beaton, D., Alten, R., Toupin April, K., Boonen, A., Escorpizo, R., Flurey, C., Furst, D. E., Guillemin, F., Leong, A., Pohl, C., Rasmussen, M. U., Singh, J. A., Smolen, J. S., Strand, V., Verstappen, S. M. M., Voshaar, M., Woodworth, T. G., Ellingsen, T., March, L., Wells, G. A., Tugwell, P. & Christensen, R., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 601-606 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To develop an operational definition of contextual factors (CF) [1].

METHODS: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

RESULTS: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

CONCLUSION: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 601-606
Antal sider 6
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

OMERACT Filter 2.1 instrument selection for physical function domain in psoriatic arthritis: Provisional endorsement for HAQ-DI and SF-36 PF

Leung, Y-Y., Orbai, A-M., Hojgaard, P., Holland, R., Mathew, A. J., Goel, N., Chau, J., Tillett, W., Lindsay, C., Ogdie, A., Coates, L. C., Gladman, D. D., Christensen, R., Mease, P. & Strand, V., okt. 2021, I: Seminars in Arthritis and Rheumatism. 51, 5, s. 1117-1124 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the physical functioning subscale of the Medical Outcome Survey Short-Form 36 items (SF-36 PF).

METHODS: We followed guidelines set out by the OMERACT Filter 2.1. A working group was formed to evaluate each instrument for domain match and feasibility to reach consensus. Two systematic literature reviews (SLRs) were conducted to identify the relevant articles supporting measurement properties of both instruments. Five additional measurement properties were appraised: construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, and threshold of meaning. New evidence was synthesized to fill the gap. Data were presented to the OMERACT technical advisory group (TAG) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) community for endorsement.

RESULTS: The results for seven measurement properties for HAQ-DI and SF-36 PF were presented in Summary of Measurement Property (SOMP) tables. The working group proposed "Provisional Endorsement" for both instruments. The body of evidence was approved by the OMERACT TAG. In two Delphi exercises among GRAPPA members, HAQ-DI received 93.9% and 97.5% endorsement votes, while that for SF-36 PF were 86.7% and 77.3%.

CONCLUSION: Both HAQ-DI and SF-36 PF were provisionally endorsed for the measurement of physical function in PsA trials, using the OMERACT Filter 2.1.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 5
Sider (fra-til) 1117-1124
Antal sider 8
ISSN 0049-0172
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

INTRODUCTION: The effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.

RESEARCH DESIGN AND METHODS: We performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, 'U-TURN'), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).

RESULTS: We included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI -0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI -4.6 to -0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).

CONCLUSION: In persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.

TRIAL REGISTRATION NUMBER: NCT02417012.

Originalsprog Engelsk
Artikelnummer e001840
Tidsskrift BMJ open diabetes research & care
Vol/bind 9
Udgave nummer 1
Sider (fra-til) 1-11
Antal sider 11
ISSN 2052-4897
DOI
Status Udgivet - jan. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Outcome domains reported by patients, caregivers, healthcare professionals and stakeholders for calcium pyrophosphate deposition (CPPD): A content analysis based on semi-structured qualitative interviews from the OMERACT CPPD working group

Fuller, A., Cai, K., Diaz-Torne, C., Filippou, G., Pascart, T., Hensey, O., Grossberg, D., Christensen, R., Shea, B., Singh, J. A., Tedeschi, S. K., Dalbeth, N. & Abhishek, A., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 650-654 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Although calcium pyrophosphate deposition (CPPD) disease is common, there are no validated outcome measures for clinical research in this condition. The aim of this study was to generate a list of outcome domains as reported by patients, their caregivers, healthcare professionals (HCPs) and stakeholders to inform the development of an Outcome Measures in Rheumatology (OMERACT) Core Domain Set for CPPD.

METHODS: Patients with CPPD and their caregivers, HCPs and stakeholders took part in semi-structured qualitative interviews to explore potential outcome domains for CPPD clinical research relevant to their lived experience and knowledge of CPPD. Interviews were conducted in six countries across three continents. Data was analysed using manifest content analysis to identify outcome domains, which were tabulated and mapped to the core areas as defined by the OMERACT Filter 2.1.

RESULTS: Thirty-six interviews were conducted in total. Participants comprised of 28 patients (six of which included a caregiver), seven HCPs and one stakeholder. The commonly identified (sub-) domains (d) across the 1) abnormalities/manifestations core area were joint pain (d = 35), joint swelling (d = 27), joint stiffness (d = 25), CPPD flares (d = 25); 2) life-impact core area were overall function (d=35), and specifically the ability to complete daily tasks (d = 25); and 3) societal/resource use core area were use of analgesic medicines (d = 26). Patients more commonly reported joint swelling, stiffness and range of movement, and use of analgesics while HCPs more commonly reported domains relating to presence of CPP crystals, radiologic calcification, joint damage, time to diagnosis and suitability of treatment.

CONCLUSION: Among a number of potential outcome domains identified, articular manifestations, function and analgesic use were most frequently mentioned by participants. These findings will be used to develop an OMERACT Core Domain Set for CPPD.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 650-654
Antal sider 5
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

Outcome measurement instrument selection for lung physiology in systemic sclerosis associated interstitial lung disease: A systematic review using the OMERACT filter 2.1 process

Roofeh, D., Barratt, S. L., Wells, A. U., Kawano-Dourado, L., Tashkin, D., Strand, V., Seibold, J., Proudman, S., Brown, K. K., Dellaripa, P. F., Doyle, T., Leonard, T., Matteson, E. L., Oddis, C. V., Solomon, J. J., Sparks, J. A., Vassallo, R., Maxwell, L., Beaton, D., Christensen, R., Townsend, W. & Khanna, D., dec. 2021, I: Seminars in Arthritis and Rheumatism. 51, 6, s. 1331-1341 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) is a research organization focused on improving health care outcomes for patients with autoimmune and musculoskeletal diseases. The Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD) Working Group on Lung Physiology is a group within OMERACT charged with identifying outcome measures that should be implemented in studies of patients with CTD-ILD. The OMERACT Filter 2.1 is an evidence-based algorithm used to identify outcome measures that are truthful, feasible, and able to discriminate between groups of interest. Our objective was to summate evidence (published literature, key opinion leader input, patient perspectives) that would influence the CTD-ILD Working Group's vote to accept or reject the use of two measures of lung physiology, the forced vital capacity (FVC) and the diffusion capacity of carbon monoxide (DLco) for use in randomized controlled trials (RTCs) and longitudinal observational studies (LOSs) involving patients with systemic sclerosis associated ILD (SSc-ILD).

METHODS: Patient Research Partners (those afflicted with SSc-ILD) and the CTD-ILD Working Group on Lung Physiology were polled to assess their opinion on the FVC and DLco in terms of feasibility; the CTD-ILD Working Group was also queried on these instruments' face and content validity. We then conducted a systematic literature review to identify articles in the SSc-ILD population that assessed the following measurement properties of FVC and DLco: (1) construct validity, (2) test-retest reliability, (3) longitudinal construct validity, (4) clinical trial discrimination/sensitivity to detect change in clinical trials, and (5) thresholds of meaning. Results were summarized in a Summary of Measurement Properties (SOMP) table for each instrument. OMERACT CTD-ILD Working Group members discussed and voted on the strength of evidence supporting these two instruments and voted to endorse, provisionally endorse, or not endorse either instrument.

RESULTS: Forty Patient Research Partners reported these two measures are feasible (are not an unnecessary burden or represent an infeasible longitudinal assessment of their disease). A majority of the 18 CTD-ILD Working Group members voted that both the FVC and DLco are feasible and have face and content validity. The systematic literature review returned 1,447 non-duplicated articles, of which 177 met eligibility for full text review. Forty-eight studies (13 RCTs, 35 LOSs) were included in the qualitative analysis. The FVC SOMP table revealed high quality, consistent data with evidence of good performance for all five measurement properties, suggesting requisite published evidence to proceed with endorsement. The DLco SOMP table showed a lack of data to support test-retest reliability and inadequate evidence to support clinical trial discrimination. There was unanimous agreement (15 [100%]) among voting CTD-ILD Working Group members to endorse the FVC as an instrument for lung physiology in RCTs and LOSs in SSc-ILD. Based on currently available evidence, DLco did not meet the OMERACT criteria and is not recommended for use in RCTs to represent lung physiology of SSc-ILD. The OMERACT Technical Advisory Group agreed with these decisions.

CONCLUSION: The OMERACT Filter 2.1 was successfully applied to the domain of lung physiology in patients with SSc-ILD. The FVC was endorsed for use in RCTs and LOSs based on the Working Group's vote; DLco was not endorsed.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 6
Sider (fra-til) 1331-1341
Antal sider 11
ISSN 0049-0172
DOI
Status Udgivet - dec. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

Outcome reporting in self-management interventions for inflammatory arthritis trials: A systematic review of outcome measures covering self-management domains

Hansen, C., Esbensen, B. A., Christensen, R. D. K., Thurah, AD. & Cromhout, P., 2021, I: Arthritis and Rheumatology. 73, No. S9, s. 1542-5 4 s., 0758.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer 0758
Tidsskrift Arthritis and Rheumatology
Vol/bind 73
Udgave nummer No. S9
Sider (fra-til) 1542-5
Antal sider 4
ISSN 2326-5191
Status Udgivet - 2021

Pages