Published in 2021

BACKGROUND: Knee osteoarthritis (OA) is a highly prevalent musculoskeletal condition causing pain, physical disability, and reduced quality of life. Exercise and patient education are non-pharmacological interventions for knee OA unanimously recommended as first-line treatments based on extensive research evidence. However, none of the numerous randomised controlled trials of exercise and education for knee OA has used adequate sham/placebo comparison groups because the 'active' ingredients are unknown. Designing and executing an adequate and 'blindable placebo' version of an exercise and education intervention is impossible. Therefore, using an open-label study design, this trial compares the efficacy of a widely used 'state-of-art' exercise and education intervention (Good Life with osteoarthritis in Denmark; GLAD) with presumably inert intra-articular saline injections on improvement in knee pain in patients with knee OA.

METHODS: In this open-label randomised trial, we will include 200 patients with radiographically verified OA of the knee and randomly allocate them to one of two interventions: (i) 8 weeks of exercise and education (GLAD) or (ii) Intra-articular injections of 5 ml isotonic saline every second week for a total of 4 injections. Outcomes are taken at baseline, after 8 weeks of treatment (week 9; primary endpoint) and after an additional 4 weeks of follow-up (week 12). The primary outcome is change from baseline in the Knee Injury and Osteoarthritis Outcome Score questionnaire (KOOS) pain subscale score. Secondary outcomes include the Physical function in Activities of Daily Living, Symptoms, and Knee-related Quality of Life subscales of the KOOS, the patients' global assessment of disease impact, physical performance tests, and presence of knee joint swelling.

DISCUSSION: This current trial compares a presumably active treatment (GLAD) with a presumably inert treatment (IA saline injections). Both study interventions have well-established and anticipated similar effects on knee OA symptoms, but the underlying mechanisms are unknown. The interpretation of the results of this trial will likely be difficult and controversial but will contribute to a better understanding of the bias introduced in the effect estimation of classically unblindable exercise and education interventions for knee OA.

TRIAL REGISTRATION: www.ClinicalTrials.gov NCT03843931 . Prospectively registered on 18 February 2019.

Originalsprog Engelsk
Artikelnummer 18
Tidsskrift Trials
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 18
ISSN 1745-6215
DOI
Status Udgivet - 6 jan. 2021

Experience and impact of crystal pyrophosphate deposition (CPPD) from a patient and caregiver perspective: A qualitative exploration from the OMERACT CPPD working group

Fuller, A., Cai, K., Filippou, G., Pascart, T., Diaz-Torne, C., 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. 655-660 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To explore the lived experience of people with calcium pyrophosphate deposition (CPPD) disease and the impact of this condition on their daily lives.

METHODS: Patients with CPPD and their caregivers were invited to take part in a one-to-one (patient only) or paired (patient and caregiver) semi-structured interview. Interviews covered patients' diagnosis and treatment experiences, and the impact of CPPD on their daily lives. Transcribed interviews were analysed using inductive thematic analysis.

RESULTS: 28 patient interviews, six of which included a caregiver, were conducted across five countries. Acute CPP crystal arthritis flares resulted in temporary but profound disability for most patients, disrupting their ability to go about day-to-day activities, and they sought immediate medical attention. CPPD+OA and chronic CPP crystal inflammatory arthritis presented patients with longer term limitations in daily lives. Patients and their caregivers described these disruptions and limitations, which included a reduced ability or inability to complete household and self-care tasks, exercise, socialise, work and drive. They also described how arthritis pain and resulting limitations adversely impacted upon patients' psychological wellbeing. Delays in referral to specialists and diagnostic uncertainty were described by many. Lack of appropriate treatment or access to treatments only upon worsening of symptoms impacted upon the length of time some patients spent in pain and with functional limitations.

CONCLUSION: This study is the first to demonstrate the wide-ranging impact of CPPD, and highlights the need for improved diagnosis, physician training, as well as greater emphasis upon finding targeted therapies to specifically treat CPPD.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 655-660
Antal sider 6
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

Facilitators and Barriers for Young Medical Doctors Writing Their First Manuscript for Publication

Raffing, R., Jensen, T. B., Larsen, S., Konge, L., Møller, C. & Tønnesen, H., 13 aug. 2021, I: International Journal of Environmental Research and Public Health. 18, 16, 8571.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Although scientific publication is often mandatory in medical professions, writing the first research article for publication is challenging, especially as medical curricula have only a minor focus on scientific writing. The aim was therefore to identify facilitators and barriers experienced by medical doctors writing their first scientific article for publication. An explorative inductive approach made use of semi-structured interviews for collecting data until saturation. Data were analyzed with systematic text condensation. Several barriers were identified: (a) writing in general; (b) writing in English; (c) dealing with content, structure, and presentation; and (d) navigating in the author group. Good supervision in the initial writing phase was a facilitating factor. Medical doctors requested a course in which they could work on their own articles and give feedback to fellow students. They valued skilled lecturers and individual supervision, and they wanted to learn about author instructions, how to present text correctly, and how to sell their core message. Their goal was to create a useful end product and to obtain European Credit Transfer System (ECTS) points. The facilitators and barriers that medical doctors experience when writing their first scientific article for publication and their course requests should be reflected in the learning objectives and content of future courses.

Originalsprog Engelsk
Artikelnummer 8571
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 18
Udgave nummer 16
ISSN 1661-7827
DOI
Status Udgivet - 13 aug. 2021

Feasibility of ABLE 1.0-a program aiming at enhancing the ability to perform activities of daily living in persons with chronic conditions

Nielsen, K. T., Guidetti, S., von Bülow, C., Klokker, L. & Wæhrens, E. E., 18 feb. 2021, I: Pilot and Feasibility Studies. 7, 1, s. 52 52.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The "A Better everyday LifE" (ABLE) intervention was developed to accommodate the need of a program addressing ability to perform activities of daily living (ADL) in persons with chronic conditions living at home. During intervention development, it is necessary to evaluate relevant aspects of the feasibility of a program. Thus, the aim was to evaluate the feasibility of content and delivery of ABLE version 1.0.

METHODS: A one group pre- and post-test design was applied. Thirty persons with chronic conditions, two occupational therapists (OTs), and five occupational therapy students (OTSs) participated. ABLE 1.0 is an 8-week program consisting of ADL evaluation (session 1); goal setting and reasons for ADL problems (session 2); intervention (sessions 3-7); and re-evaluation (final session), conducted in the clients' home-setting and local area. Sessions 1-4 and the final session was mandatory. To evaluate the feasibility of content and delivery, the OTs, after each session, reported on applied intervention component(s), time-use, needed equipment, adjustments, meaningfulness, confidence, progress toward goal attainment, and side effects using registration forms. The clients reported on progress toward goal attainment, meaningfulness, and satisfaction. Clinically relevant improvements in ADL ability were identified using the ADL-Interview (ADL-I) and the Assessment of Motor and Process Skills (AMPS). Goal attainment was evaluated using the Goal Attainment Scaling (GAS).

RESULTS: Twenty clients (67%) completed ABLE 1.0 and received four sessions (median = 4, range 4-7) each lasting between 30 and 94 min. Most frequently applied component was "Changing habits related to task performance". Generally, OTs reported having the needed equipment. Deviations from the manual were made by omission of GAS and AMPS and less than mandatory number of sessions per client. The OTs reported confidence in delivering the program and the clients perceived the program as meaningful and satisfying, and experienced progress toward goal attainment. Goal attainment was found in 52% of the goals. Sixteen (80%) clients obtained clinically relevant improvements in self-reported or observed ADL ability.

CONCLUSIONS: The content and delivery of ABLE 1.0 was feasible. However, the study revealed a need to adjust the recruitment procedure and make minor changes in the intervention manual. A pilot randomized controlled trial (RCT) study is recommended.

TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with registration no. NCT03335709 on November 8, 2017.

Originalsprog Engelsk
Artikelnummer 52
Tidsskrift Pilot and Feasibility Studies
Vol/bind 7
Udgave nummer 1
Sider (fra-til) 52
ISSN 2055-5784
DOI
Status Udgivet - 18 feb. 2021

GRADE guidelines 32: GRADE offers guidance on choosing targets of GRADE certainty of evidence ratings

Zeng, L., Brignardello-Petersen, R., Hultcrantz, M., Siemieniuk, R. A. C., Santesso, N., Traversy, G., Izcovich, A., Sadeghirad, B., Alexander, P. E., Devji, T., Rochwerg, B., Murad, M. H., Morgan, R., Christensen, R., Schünemann, H. J. & Guyatt, G. H., sep. 2021, I: Journal of Clinical Epidemiology. 137, s. 163-175 13 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To provide practical principles and examples to help GRADE users make optimal choices regarding their ratings of certainty of evidence using a minimally or partially contextualized approach.

STUDY DESIGN AND SETTING: Based on the GRADE clarification of certainty of evidence in 2017, a project group within the GRADE Working Group conducted iterative discussions and presentations at GRADE Working Group meetings to refine this construct and produce practical guidance.

RESULTS: Systematic review and health technology assessment authors need to clarify what it is in which they are rating their certainty of evidence (i.e., the target of their certainty rating). The decision depends on the degree of contextualization (partially or minimally contextualized), thresholds (null, small, moderate or large effect threshold), and where the point estimate lies in relation to the chosen threshold(s). When the 95% confidence interval crosses multiple possible thresholds (i.e., including both large benefit and large harm), it is not worthwhile for authors to determine the target of certainty rating.

CONCLUSION: GRADE provides practical principles to help systematic review and health technology assessment authors specify the target of their certainty of evidence rating.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 137
Sider (fra-til) 163-175
Antal sider 13
ISSN 0895-4356
DOI
Status Udgivet - sep. 2021

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group

OMERACT Safety Working Group, jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 607-617 11 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

BACKGROUND: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms.

METHODS: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting.

RESULTS: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review.

CONCLUSIONS: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives.

REGISTRATION: PROSPERO: CRD42018108393.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 607-617
Antal sider 11
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

OBJECTIVES: Patients with inflammatory arthritis (IA) have a high risk of sleep disturbances and disorders. The objective was to evaluate the evidence of non-pharmacological interventions targeting sleep disturbances or disorders in patients with IA.

METHODS: A systematic search was undertaken from inception to September 8th , 2020. We included randomized trials concerning non-pharmacological interventions applied in adults with IA and concomitant sleep disturbances or disorders. Primary outcome was the sleep domain while secondary outcomes were core outcome domains for IA trials and harms. The Cochrane Risk of Bias tool was applied, and the overall quality of the evidence was assessed using GRADE. Effect sizes for continuous outcomes were based on the standardized mean difference, combined using random-effects meta-analysis.

RESULTS: Six trials (308 patients) were included in the quantitative synthesis; three of these reported improvement in sleep in favor of the non-pharmacological intervention(s). The meta-analysis of the sleep domains indicated a large clinical effect of -0.80 (95% CI, -1.33 to -0.28) in favor of non-pharmacological interventions targeting sleep disturbances or disorders. The estimate was rated down twice for risk of bias, and unexplained inconsistency; this was assessed as corresponding to low quality evidence. None of the secondary core outcomes used in contemporary IA trials indicated clinical benefit in favor of non-pharmacological interventions targeting sleep.

CONCLUSION: Non-pharmacological interventions targeting sleep disturbances/disorders in patients with IA indicated a promising effect on sleep outcomes, but not yet with convincing evidence.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
ISSN 2151-464X
DOI
Status E-pub ahead of print - 13 jun. 2021

Increased cancer risk in patients with cutaneous lupus erythematosus and systemic lupus erythematosus compared with the general population: A Danish nationwide cohort study

Westermann, R., Zobbe, K., Cordtz, R., Haugaard, J. H. & Dreyer, L., apr. 2021, I: Lupus. 30, 5, s. 752-761 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To investigate if patients with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) have an increased risk of cancer compared with the general population, and furthermore to identify specific cancer types associated with increased risk.

METHODS: This is an observational cohort study of 5310 patients with CLE or SLE identified in the Danish National Patient Register from 1 January 1995 to 31 December 2014. The cohort was followed up for cancer by linkage to the Danish Cancer Registry. Based on the age, sex, and calendar specific cancer rates of the general population of Denmark, standardised incidence ratios (SIRs) were calculated.

RESULTS: The patients with CLE or SLE were followed for 40.724 person-years, each group's average duration of follow-up being 6.9 and 8.1 years. The SIR for overall cancer (except non-melanoma skin cancer (NMSC)) was increased in patients with CLE 1.35 (95%CI 1.15 to 1.58) and patients with SLE 1.45 (95%CI 1.30 to 1.62). Both groups had high risks of hematological - including a 3-4-fold increased risk of non-Hodgkin lymphoma -, pancreatic, and lung cancers. Several cancers associated with oncogenic viruses as liver and tongue/mouth/pharynx were increased in the SLE group, while the risk of ovarian cancer was increased 2-4-fold only in the CLE group.

CONCLUSION: The overall risk of cancer was significantly increased in both patients with CLE and SLE. SIRs for hematological, pancreatic and lung cancers were elevated in both groups. Extra awareness of cancer in patients with SLE and patients with CLE should be considered.

Originalsprog Engelsk
Tidsskrift Lupus
Vol/bind 30
Udgave nummer 5
Sider (fra-til) 752-761
Antal sider 10
ISSN 0961-2033
DOI
Status Udgivet - apr. 2021

BACKGROUND AND PURPOSE: Mortality following infections in dementia has not yet been comprehensively explored. The aim of this cohort study was to investigate the short- and long-term mortality following infections in dementia.

METHODS: Follow-up was from 1 January 2000 or the 65-year birthday until death, immigration, or 31 December 2015. Exposure was incident dementia and a first infection. The outcome was all-cause mortality. Mortality rate ratios (MRRs) were calculated using Poisson regression in 4 exposure groups (dementia yes/no, infection yes/no) by sex, infection site, and time since infection.

RESULTS: 1,496,436 people were followed with 12,739,135 person-years. MRR in dementia/infection was 6.52 (95% confidence interval: 6.43-6.60) and was increased for infections of all sites. Increased mortality was short term (30 days) and long term (10 years).

CONCLUSIONS: Increased mortality in people with dementia identifies them as a particularly vulnerable group that needs clinical attention.

Originalsprog Engelsk
Artikelnummer 2
Tidsskrift European Journal of Neurology
Vol/bind 28
Sider (fra-til) 411-420
ISSN 1351-5101
DOI
Status Udgivet - feb. 2021

Bibliografisk note

© 2020 European Academy of Neurology.

Inflammatory hallmarks of lesser prominence in psoriatic arthritis patients starting biologics: a Nordic population-based cohort study

Lund Hansen, R., Schoedt Jørgensen, T., Dreyer, L., Hetland, M. L., Glintborg, B., Askling, J., Di Giuseppe, D., Jacobsson, L. T. H., Wallman, J. K., Nordstrom, D., Aaltonen, K., Kristianslund, E. K., Kvien, T. K., Provan, S. A., Gudbjornsson, B., Love, T. J. & Kristensen, L. E., 1 jan. 2021, I: Rheumatology (Oxford, England). 60, 1, s. 140-146 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To assess secular trends in baseline characteristics of PsA patients initiating their first or subsequent biologic DMARD (bDMARD) therapy and to explore prescription patterns and treatment rates of bDMARDs from 2006 to 2017 in the Nordic countries.

METHODS: PsA patients registered in the Nordic rheumatology registries initiating any treatment with bDMARDs were identified. The bDMARDs were grouped as original TNF inhibitor [TNFi; adalimumab (ADA), etanercept (ETN) and infliximab (IFX)]; certolizumab pegol (CZP) and golimumab (GOL); biosimilars and ustekinumab, based on the date of release. Baseline characteristics were compared for the five countries, supplemented by secular trends with R2 calculations and point prevalence of bDMARD treatment.

RESULTS: A total of 18 089 patients were identified (Denmark, 4361; Iceland, 449; Norway, 1948; Finland, 1069; Sweden, 10 262). A total of 54% of the patients were female, 34.3% of patients initiated an original TNFi, 8% CZP and GOL, 7.5% biosimilars and 0.3% ustekinumab as a first-line bDMARD. Subsequent bDMARDs were 25.2% original TNFi, 9% CZP and GOL, 12% biosimilars and 2.1% ustekinumab. From 2015 through 2017 there was a rapid uptake of biosimilars. The total of first-line bDMARD initiators with lower disease activity increased from 2006 to 2017, where an R2 close to 1 showed a strong association.

CONCLUSION: Across the Nordic countries, the number of prescribed bDMARDs increased from 2006 to 2017, indicating a previously unmet need for bDMARDs in the PsA population. In recent years, PsA patients have initiated bDMARDs with lower disease activity compared with previous years, suggesting that bDMARDs are initiated in patients with a less active inflammatory phenotype.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 1
Sider (fra-til) 140-146
Antal sider 7
ISSN 1462-0324
DOI
Status Udgivet - 1 jan. 2021

Bibliografisk note

COPECARE

OBJECTIVE: The aim of this study is to investigate the influence of local anesthetic (LA), operator experience level and needle type on patient procedural pain in relation to diagnostic lumbar puncture (LP).

METHODS: LP was performed with either a 22 gauge traumatic needle (22 TN) or a 22 gauge atraumatic needle (22 ATN). Immediately after LP patients documented a procedural pain score (PPS) on a 10-point Likert scale. Use of LA, needle type, anesthetic time interval (ATI), number of needle insertions and the LP operator experience level were registered. ATI was defined as the time from administration of LA to first needle insertion.

RESULTS: 104 patients had the LP procedure performed by 66 physicians (40 novices and 26 experienced physicians). Patients having the procedure performed by novices had a lower PPS of 2.56 if LA was administered compared to a higher PPS of 5.80 if LA was not administered (P = .046). Among experienced physicians there was no difference in PPS regardless of administration of LA. If novices administered LA, patient PPS was equal to patients having the procedure performed by an experienced operator. If novices performed the procedure with a 22 TN PPS decreased with increasing ATI (P = .01). No similar correlation was identified with the 22 ATN.

CONCLUSION: Our study suggests that LP operator experience level, the needle type used and ATI may influence patient PPS. Further studies are necessary for final conclusions. These studies must consider these factors to avoid fault conclusions.

Originalsprog Engelsk
Tidsskrift International Journal of Emergency Medicine
ISSN 0735-6757
DOI
Status E-pub ahead of print - 2021

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Instruments Measuring Physical Function for Psoriatic Arthritis Endorsed at GRAPPA 2020 Annual Meeting: Updates of the GRAPPA-OMERACT Working Group

Leung, Y. Y., Orbai, A-M., Tillett, W., Ogdie, A., Eder, L., Goel, N., Hojgaard, P., Holland, R., Mathew, A. J., Lindsay, C. A., Antony, A., Chau, J., Christensen, R., Coates, L. C., Mease, P. J., Strand, V., FitzGerald, O., de Wit, M., Duffin, K. C. & Gladman, D. D., jun. 2021, I: The Journal of rheumatology. Supplement. 97, s. 60-63 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group provided updates at the 2020 GRAPPA annual meeting on its work toward developing a core outcome set for PsA. Working groups were set up for the 4 prioritized domains: enthesitis, fatigue, structural damage, and physical function. Two instruments for measurement of physical function were provisionally endorsed: (1) the Health Assessment Questionnaire-Disability Index and (2) the physical functioning domain in the Medical Outcomes Study 36-item Short Form survey.

Originalsprog Engelsk
Tidsskrift The Journal of rheumatology. Supplement
Vol/bind 97
Sider (fra-til) 60-63
Antal sider 4
ISSN 0380-0903
DOI
Status Udgivet - jun. 2021

Knee replacement outcome predicted by physiotherapists: a prospective cohort study

Henriksen, M., Mukriyani, H. & Juhl, C., 23 feb. 2021, I: PeerJ. 9, s. e10838 e10838.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Knee arthroplasty (KA) is commonly used for osteoarthritis of the knee joint and it is a highly successful procedure. Still, KA leaves 20% of patients dissatisfied with their outcome. The purpose of this study was to determine if a prognosis made by physiotherapists at the orthopaedic wards during the first post-operative days could predict the 6- and 12-months outcome of KA.

Methods: Physiotherapists at two orthopaedic wards in Denmark were asked to predict the 6- and 12-months outcome of the KA patients they have treated post-operatively on a 0-10 scale (10 representing the best prognosis). At 6 and 12 months post-operatively the patients answered the Oxford Knee Score (OKS), EuroQol 5D-3L and Patient Acceptable Symptom State (PASS). Multivariable logistic regression analyses were performed to assess the prediction of PASS and treatment success. We assessed predictive performance by examining measures of calibration and discrimination.

Results: A total of 361 patients were included. The models for PASS and Treatment Success showed poor to acceptable discriminative values (OR between 1.47 and 1.92 and areas under the curves of 0.62-0.73), however the calibration plots indicated significant uncertainties in the prediction.

Conclusion: Physiotherapists prognoses of recovery after KA are associated with 6- and 12-months patient reported outcomes and satisfaction but have weak predictive value. This study suggests that physiotherapists' prognoses may be useful as an additional source of information when identifying patients in need of additional post-operative care.

Originalsprog Engelsk
Artikelnummer e10838
Tidsskrift PeerJ
Vol/bind 9
Sider (fra-til) e10838
ISSN 2167-8359
DOI
Status Udgivet - 23 feb. 2021

Laminar airflow versus turbulent airflow in simulated total hip arthroplasty: measurements of colony-forming units, particles, and energy consumption

Marsault, L. V., Ravn, C., Overgaard, A., Frich, L. H., Olsen, M., Anstensrud, T., Nielsen, J. & Overgaard, S., sep. 2021, I: The Journal of hospital infection. 115, s. 117-123 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The optimal type of ventilation in operating theatres for joint arthroplasty has been debated for decades. Recently, the World Health Organization changed its recommendations based on articles that have since been criticized. The economic and environmental impact of ventilation is also currently an important research topic but has not been well investigated.

AIM: To compare how large, high-volume, laminar airflow (LAF) and turbulent airflow (TAF) ventilation systems perform during standardized simulated total hip arthroplasty (THA), as they pertain to colony-forming units (cfu), particle counts, and energy consumption.

METHODS: Two identical operating theatres were used to perform simulated THA. The only difference was that one was equipped with LAF and the other with TAF. Cfu and particles were collected from key points in the operating theatre, and energy was measured for each simulation. Thirty-two simulations were done in total.

FINDINGS: LAF had significantly reduced cfu and particle count when compared with TAF, at both 100% and 50% air influx. Furthermore, it was shown that lowering the air influx by 50% in LAF did not significantly affect cfu or particles, although reducing the fresh air influx from 100% to 50% significantly lowered the energy consumption. Most simulations in TAF did not meet the cleanroom requirements.

CONCLUSION: Cfu were significantly lower in LAF at both 100% and 50% air influx. It is possible to reduce fresh air influx in LAF operating theatres by 50%, significantly reducing energy consumption, while still maintaining cfu and particle counts below the ISO classification threshold required for THA surgery.

Originalsprog Engelsk
Tidsskrift The Journal of hospital infection
Vol/bind 115
Sider (fra-til) 117-123
Antal sider 7
ISSN 0195-6701
DOI
Status Udgivet - sep. 2021

BACKGROUND: Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA).

OBJECTIVE: To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA.

METHODS: The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2).Patients underwent a pre-random assignment diet intervention (week -8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52.

RESULTS: In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre-random assignment dietary intervention period (week -8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: -2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: -6.9, -1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and -0.6 points, respectively; group difference, 0.9 points; 95% CI: -3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.

CONCLUSIONS: In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre-random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.

Originalsprog Engelsk
Tidsskrift The American journal of clinical nutrition
Vol/bind 113
Udgave nummer 2
Sider (fra-til) 314-323
Antal sider 10
ISSN 0002-9165
DOI
Status Udgivet - feb. 2021

Bibliografisk note

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

Long-term exposure to ambient air pollution and road traffic noise and asthma incidence in adults: The Danish Nurse cohort

Liu, S., Lim, Y. H., Pedersen, M., Jørgensen, J. T., Amini, H., Cole-Hunter, T., Mehta, A. J., So, R., Mortensen, L. H., Westendorp, R. G. J., Loft, S., Bräuner, E. V., Ketzel, M., Hertel, O., Brandt, J., Jensen, S. S., Christensen, J. H., Sigsgaard, T., Geels, C., Frohn, L. M., Brborić, M., Radonić, J., Sekulic, M. T., Bønnelykke, K., Backalarz, C., Simonsen, M. K. & Andersen, Z. J., 1 jul. 2021, I: Environment International. 152, s. 106464 106464.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Ambient air pollution is likely a risk factor for asthma, and recent evidence suggests the possible relevance of road traffic noise.

OBJECTIVES: We examined the associations of long-term exposure to air pollution and road traffic noise with adult-asthma incidence.

METHODS: We followed 28,731 female nurses (age > 44 years) from the Danish Nurse Cohort, recruited in 1993 and 1999, for first hospital contact for asthma from 1977 until 2015. We estimated residential annual mean concentrations of particulate matter with diameter < 2.5 µm (PM
2.5) since 1990 and nitrogen dioxide (NO
2) since 1970 with the Danish DEHM/UBM/AirGIS modeling system, and road traffic noise (L
den) since 1970 with the Nord2000 model. Time-varying Cox regression models were used to associate air pollution and road traffic noise exposure with asthma incidence.

RESULTS: During 18.6 years' mean follow-up, 528 out of 23,093 participants had hospital contact for asthma. The hazard ratios (HR) and 95% confidence intervals for asthma incidence associated with 3-year moving average exposures were 1.29 (1.03, 1.61) per 6.3 µg/m
3 for PM
2.5, 1.16 (1.07, 1.27) per 8.2 µg/m
3 for NO
2, and 1.12 (1.00, 1.25) per 10 dB for L
den. The HR for NO
2 remained unchanged after adjustment for either PM
2.5 or L
den, while the HRs for PM
2.5 and L
den attenuated to unity after adjustment for NO
2.

CONCLUSIONS: Long-term exposure to air pollution was associated with adult-asthma incidence independently of road traffic noise, with NO
2 most relevant. Road traffic noise was not independently associated with adult-asthma incidence.

Originalsprog Engelsk
Artikelnummer 106464
Tidsskrift Environment International
Vol/bind 152
Sider (fra-til) 106464
ISSN 0160-4120
DOI
Status Udgivet - 1 jul. 2021

Long-term low-level ambient air pollution exposure and risk of lung cancer - A pooled analysis of 7 European cohorts

Hvidtfeldt, U. A., Severi, G., Andersen, Z. J., Atkinson, R., Bauwelinck, M., Bellander, T., Boutron-Ruault, M-C., Brandt, J., Brunekreef, B., Cesaroni, G., Chen, J., Concin, H., Forastiere, F., van Gils, C. H., Gulliver, J., Hertel, O., Hoek, G., Hoffmann, B., de Hoogh, K., Janssen, N., Jöckel, K-H., Jørgensen, J. T., Katsouyanni, K., Ketzel, M., Klompmaker, J. O., Krog, N. H., Lang, A., Leander, K., Liu, S., Ljungman, P. L. S., Magnusson, P. K. E., Mehta, A. J., Nagel, G., Oftedal, B., Pershagen, G., Peter, R. S., Peters, A., Renzi, M., Rizzuto, D., Rodopoulou, S., Samoli, E., Schwarze, P. E., Sigsgaard, T., Simonsen, M. K., Stafoggia, M., Strak, M., Vienneau, D., Weinmayr, G., Wolf, K., Raaschou-Nielsen, O. & Fecht, D., jan. 2021, I: Environment International. 146, s. 106249 106249.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND/AIM: Ambient air pollution has been associated with lung cancer, but the shape of the exposure-response function - especially at low exposure levels - is not well described. The aim of this study was to address the relationship between long-term low-level air pollution exposure and lung cancer incidence.

METHODS: The "Effects of Low-level Air Pollution: a Study in Europe" (ELAPSE) collaboration pools seven cohorts from across Europe. We developed hybrid models combining air pollution monitoring, land use data, satellite observations, and dispersion model estimates for nitrogen dioxide (NO2), fine particulate matter (PM2.5), black carbon (BC), and ozone (O3) to assign exposure to cohort participants' residential addresses in 100 m by 100 m grids. We applied stratified Cox proportional hazards models, adjusting for potential confounders (age, sex, calendar year, marital status, smoking, body mass index, employment status, and neighborhood-level socio-economic status). We fitted linear models, linear models in subsets, Shape-Constrained Health Impact Functions (SCHIF), and natural cubic spline models to assess the shape of the association between air pollution and lung cancer at concentrations below existing standards and guidelines.

RESULTS: The analyses included 307,550 cohort participants. During a mean follow-up of 18.1 years, 3956 incident lung cancer cases occurred. Median (Q1, Q3) annual (2010) exposure levels of NO2, PM2.5, BC and O3 (warm season) were 24.2 µg/m3 (19.5, 29.7), 15.4 µg/m3 (12.8, 17.3), 1.6 10-5m-1 (1.3, 1.8), and 86.6 µg/m3 (78.5, 92.9), respectively. We observed a higher risk for lung cancer with higher exposure to PM2.5 (HR: 1.13, 95% CI: 1.05, 1.23 per 5 µg/m3). This association was robust to adjustment for other pollutants. The SCHIF, spline and subset analyses suggested a linear or supra-linear association with no evidence of a threshold. In subset analyses, risk estimates were clearly elevated for the subset of subjects with exposure below the EU limit value of 25 µg/m3. We did not observe associations between NO2, BC or O3 and lung cancer incidence.

CONCLUSIONS: Long-term ambient PM2.5 exposure is associated with lung cancer incidence even at concentrations below current EU limit values and possibly WHO Air Quality Guidelines.

Originalsprog Engelsk
Artikelnummer 106249
Tidsskrift Environment International
Vol/bind 146
Sider (fra-til) 106249
ISSN 0160-4120
DOI
Status Udgivet - jan. 2021

Longitudinal association of nighttime sleep duration with emotional and behavioral problems in early childhood: results from the Danish Healthy Start Study

Zheng, M., Rangan, A., Olsen, N. J. & Heitmann, B. L., 1 jan. 2021, I: Sleep. 44, 1, zsaa138.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

STUDY OBJECTIVES: To examine the longitudinal and bidirectional association between nighttime sleep duration and emotional and behavioral problems (EBPs) over 15 months among preschool children.

METHODS: Data of children aged 2 to 6 years from the control group of the Danish Healthy Start Study, a 15-month obesity prevention intervention, were used. Nighttime sleep duration was measured using a 7-day sleep record. EBPs were assessed by the Strengths and Difficulties Questionnaire Total Difficulties (SDQ-TD) score and Prosocial Behavior (SDQ-PSB) score. Multivariable regression models were conducted to examine the bidirectional associations between changes in nighttime sleep duration and SDQ scores.

RESULTS: With adjustment for child, family factors, and parental stress level, every hour extra nighttime sleep at baseline was associated with a 1.02 decrease in SDQ-TD score and 77% lower odds of having an abnormal SDQ-TD score (≥90th percentile) at the follow-up (p = 0.01). Children who increased their nighttime sleep duration over the 15-month demonstrated a similar concurrent reduction in SDQ-TD score (β = -1.28, p = 0.02) compared with those who decreased or had no change in nighttime sleep duration. After additional adjustment for sleep problem and habit variables, the significant associations remained. No associations were found between nighttime sleep duration and SDQ-PSB scores. Examination of SDQ scores as predictors of subsequent changes in nighttime sleep duration showed no significant associations.

CONCLUSIONS: Among preschool children, longer nighttime sleep duration was associated with a decline in EBPs, but not vice versa. Our study provides new longitudinal evidence to support sleep interventions to improve EBPs in early childhood.Clinical trials: The Healthy Start Study: https://clinicaltrials.gov/ct2/show/NCT01583335Trial registration: ID NCT01583335.

Originalsprog Engelsk
Artikelnummer zsaa138
Tidsskrift Sleep
Vol/bind 44
Udgave nummer 1
ISSN 1550-9109
DOI
Status Udgivet - 1 jan. 2021

To examine associations between fruit and vegetable intake in young childhood and height attainment during preschool and at school entry. Data for this study was based on "The Healthy Start" primary intervention study, which included 635 obesity-prone children, (58% boys), from the greater Copenhagen area, with a mean (SD) age of 4.0 (1.1) years (age range 2-6 years) at baseline. In the current study, 553 children (57% boys) were included with information on dietary intake at baseline and height measured at baseline (preschool age), and 511 children (56.8% boys) with the height measured at school entry (~6 years old). Height was measured by trained health professionals during the intervention and by school nurses at school entry. Information on intakes of fruit and vegetables, separately and combined, was gathered with four-day dietary records reported by parents. Participants were grouped into tertiles for their intakes at baseline. Compared to boys with low consumption, those with a moderate and high intakes of fruit and vegetables (F&V) had a greater attained height at preschool of 1.3 cm (95% confidence interval (CI): 0.3; 2.3) and at school entry of 2.4 cm (95% CI: 0.8; 3.9) and 1.8 cm (95% CI: 0.2; 3.4), respectively, also after adjustment for differences in age, body mass index (BMI), and total energy intake. Additional adjustment for mid-parental height and parents' education did not alter the significant associations between moderate consumption of F&V and attained height at preschool and school entry. There was no association among girls. Our results showed that a moderate consumption of F&V was directly associated with higher attainment in height at preschool and school entry in boys. From a public health perspective, it should be prioritized to continue developing intervention programs to improve fruit and vegetable intake.

Originalsprog Engelsk
Artikelnummer 6106
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 18
Udgave nummer 11
ISSN 1661-7827
DOI
Status Udgivet - 5 jun. 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

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