Published in 2021

'Standing together - at a distance': Documenting changes in mental-health indicators in Denmark during the COVID-19 pandemic

Clotworthy, A., Dissing, A. S., Nguyen, T-L., Jensen, A. K., Andersen, T. O., Bilsteen, J. F., Elsenburg, L. K., Keller, A., Kusumastuti, S., Mathisen, J., Mehta, A., Pinot de Moira, A., Rod, M. H., Skovdal, M., Strandberg-Larsen, K., Tapager, I. W., Varga, T. V., Vinther, J. L., Xu, T., Hoeyer, K. & Hulvej Rod, N., feb. 2021, I: Scandinavian Journal of Public Health. Supplement. 49, 1, s. 79-87 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Aims: There is a need to document the mental-health effects of the COVID-19 pandemic and its associated societal lockdowns. We initiated a large mixed-methods data collection, focusing on crisis-specific worries and mental-health indicators during the lockdown in Denmark. Methods: The study incorporated five data sources, including quantitative surveys and qualitative interviews. The surveys included a time series of cross-sectional online questionnaires starting on 20 March 2020, in which 300 (3×100) Danish residents were drawn every three days from three population groups: the general population (N=1046), families with children (N=1032) and older people (N=1059). These data were analysed by trend analysis. Semi-structured interviews were conducted with 32 people aged 24-83 throughout Denmark to provide context to the survey results and to gain insight into people's experiences of the lockdown. Results: Absolute level of worries, quality of life and social isolation were relatively stable across all population groups during the lockdown, although there was a slight deterioration in older people's overall mental health. Many respondents were worried about their loved ones' health (74-76%) and the potential long-term economic consequences of the pandemic (61-66%). The qualitative interviews documented significant variation in people's experiences, suggesting that the lockdown's effect on everyday life had not been altogether negative. Conclusions: People in Denmark seem to have managed the lockdown without alarming changes in their mental health. However, it is important to continue investigating the effects of the pandemic and various public-health measures on mental health over time and across national contexts.

Originalsprog Engelsk
Bogserie Scandinavian Journal of Public Health. Supplement
Vol/bind 49
Udgave nummer 1
Sider (fra-til) 79-87
Antal sider 9
ISSN 1403-4956
DOI
Status Udgivet - feb. 2021

A new tool to assess Clinical Diversity In Meta-analyses (CDIM) of interventions

Barbateskovic, M., Koster, T. M., Eck, R. J., Maagaard, M., Afshari, A., Blokzijl, F., Cronhjort, M., Dieperink, W., Fabritius, M. L., Feinberg, J., French, C., Gareb, B., Geisler, A., Granholm, A., Hiemstra, B., Hu, R., Imberger, G., Jensen, B. T., Jonsson, A. B., Karam, O., Kong, D. Z., Korang, S. K., Koster, G., Lai, B., Liang, N., Lundstrøm, L. H., Marker, S., Meyhoff, T., Nielsen, E. E., Nørskov, A. K., Munch, M. W., Risom, E. C., Rygård, S. L., Safi, S., Sethi, N., Sjövall, F., Lauridsen, S. V., van Bakelen, N., Volbeda, M., van der Horst, I., Gluud, C., Perner, A., Møller, M. H., Keus, F. & Wetterslev, J., 6 feb. 2021, (E-pub ahead of print) I: Journal of Clinical Epidemiology. 135, s. 29-41 13 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions.

STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups.

RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age; sex; patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention; timing; control intervention; cointerventions);and outcome (definition of outcome; timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters.

CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 135
Sider (fra-til) 29-41
Antal sider 13
ISSN 0895-4356
DOI
Status E-pub ahead of print - 6 feb. 2021

OBJECTIVE: We assessed the association of suPAR (soluble urokinase plasminogen activator receptor) plasma levels with fibrotic and vascular manifestations in patients with systemic sclerosis (SSc).

METHODS: suPAR plasma levels were measured in 121 consecutive patients with SSc and correlated to pulmonary and vascular features of SSc, including interstitial lung disease as characterized by percentage of predicted CO diffusing capacity (DLco) and forced vital capacity (FVC), pulmonary fibrosis by computed tomography, and pulmonary arterial hypertension, telangiectasias, and digital ulcers.

RESULTS: Overall, 121 SSc patients (84% females; mean age, 57 ± 12 [range: 22-79] years) were enrolled; 35% had diffuse cutaneous SSc. suPAR plasma levels ranged from 1.3-10.2 [median: 2.9 (p25-p75: 2.3-3.9)] ng/mL. Log(suPAR) levels correlated with DLco (r = -0.41, p <0.0001) and FVC (r = -0.26, p = 0.004), also when adjusted for age, sex, and pulmonary hypertension. A suPAR cut-off level of >2.5 ng/mL showed a sensitivity of 91% for identifying patients with either DLco <50% or FVC < 60% of the predicted values. Similarly, 19 (90%) had a suPAR >2.5 ng/mL among those diagnosed with pulmonary fibrosis vs. 59 (60%) among those who did not (p = 0.008). suPAR values were not associated with vascular manifestations.

CONCLUSION: suPAR levels strongly correlated with pulmonary involvement in SSc. Future studies should test if suPAR estimation can be used for surveillance of severe pulmonary involvement in SSc.

Originalsprog Engelsk
Tidsskrift PLoS One
Vol/bind 16
Udgave nummer 2
Sider (fra-til) e0247256
ISSN 1932-6203
DOI
Status Udgivet - 22 feb. 2021

STUDY DESIGN: Randomized controlled trial with 1-year follow up.

OBJECTIVE: To assess whether people with low back pain (LBP) and self-reported physically demanding jobs, benefit from an occupational medicine intervention, in addition to a single hospital consultation and an MRI, at 1 year of follow-up. Secondly, to examine whether the positive health effects, found in both groups at 6 months, persist at 1-year follow-up.

SUMMARY OF BACKGROUND DATA: The prevalence of LBP is high in the working population, resulting in a substantial social and economic burden. Although there are many guidelines available on the management of LBP, including multidisciplinary biopsychosocial rehabilitation, they provide limited guidance on the occupational medicine aspects.

METHODS: As reported previously, 305 participants with LBP and self-reported physically demanding jobs were enrolled in the randomized controlled study and randomly allocated to clinical care with additional occupational medicine intervention or clinical care alone. Data was collected at baseline, 6 months and 1 year. Outcomes included in the present 1-year follow up study are changes in neuropathic pain (painDETECT questionnaire), severity of pain (0-10 numerical rating scale), disability (Roland Morris Disability Questionnaire), fear-avoidance beliefs (FABQ), physical, and mental quality of life (SF-36).

RESULTS: The study showed no effect of an occupational intervention on neuropathic pain, fear-avoidance beliefs, physical and mental quality of life nor disability measured after one year. The positive effects found at 6 months in both groups, remained at 1-year follow-up.

CONCLUSIONS: The results suggest that a thorough clinical consultation, with focus on explaining the cause of pain and instructions to stay active, can promote long-lasting physical and mental health in individuals with LBP. Therefore, additional occupational interventions could focus on altering occupational obstacles on a structural level.

LEVEL OF EVIDENCE: 2.

Originalsprog Engelsk
Tidsskrift Spine
Vol/bind 46
Udgave nummer 6
Sider (fra-til) 347-355
Antal sider 9
ISSN 0362-2436
DOI
Status Udgivet - 15 mar. 2021

Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial

Jeppesen, P., Wolf, R. T., Nielsen, S. M., Christensen, R., Plessen, K. J., Bilenberg, N., Thomsen, P. H., Thastum, M., Neumer, S-P., Puggaard, L. B., Pedersen, M. M. A., Pagsberg, A. K., Silverman, W. K. & Correll, C. U., 1 mar. 2021, I: JAMA Psychiatry.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Importance: Behavioral therapy and cognitive-behavioral therapy (CBT) programs targeting a single class of problems have not been widely implemented. The population of youths with common mental health problems is markedly undertreated. Objective: To determine the effectiveness of a new transdiagnostic CBT program (Mind My Mind [MMM]) compared with management as usual (MAU) in youths with emotional and behavioral problems below the threshold for referral to mental health care. Design, Setting, and Participants: This pragmatic, multisite, randomized clinical trial of MMM vs MAU was conducted from September 7, 2017, to August 28, 2019, including 8 weeks of postintervention follow-up, in 4 municipalities in Denmark. Consecutive help-seeking youths were randomized (1:1) to the MMM or the MAU group. Main inclusion criteria were age 6 to 16 years and anxiety, depressive symptoms, and/or behavioral disturbances as a primary problem. Data were analyzed from August 12 to October 25, 2019. Interventions: The MMM intervention consisted of 9 to 13 weekly, individually adapted sessions of manualized CBT delivered by local psychologists. The MAU group received 2 care coordination visits to enhance usual care. Main Outcomes and Measures: The primary outcome was change in mental health problems reported by parents at week 18, using the Strengths and Difficulties Questionnaire (SDQ) Impact scale (range, 0-10 points, with higher scores indicating greater severity of distress and impairment). Primary and secondary outcomes were assessed in the intention-To-Treat population at week 18. Maintenance effects were assessed at week 26. Results: A total of 396 youths (mean [SD] age, 10.3 [2.4] years; 206 [52.0%] boys) were randomized to MMM (n = 197) or MAU (n = 199), with primary outcome data available in 177 (89.8%) and 167 (83.9%), respectively, at 18 weeks. The SDQ Impact score decreased by 2.34 points with MMM and 1.23 with MAU, from initial scores of 4.12 and 4.21, respectively (between-group difference, 1.10 [95% CI, 0.75-1.45]; P <.001; Cohen d = 0.60). Number of responders (≥1-point reduction in SDQ Impact score) was greater with MMM than with MAU (144 of 197 [73.1%] vs 93 of 199 [46.7%]; number needed to treat, 4 [95% CI, 3-6]). Secondary outcomes indicated statistically significant benefits in parent-reported changes of anxiety, depressive symptoms, daily functioning, school attendance, and the principal problem. All benefits were maintained at week 26 except for school attendance. Conclusions and Relevance: In this randomized clinical trial, the scalable transdiagnostic cognitive-behavioral intervention MMM outperformed MAU in a community setting on multiple, clinically relevant domains in youth with emotional and behavioral problems. Trial Registration: ClinicalTrials.gov Identifier: NCT03535805.

Originalsprog Engelsk
Tidsskrift JAMA Psychiatry
ISSN 2168-622X
DOI
Status Udgivet - 1 mar. 2021

BACKGROUND: Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown.

PURPOSE: To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care.

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

METHODS: Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period.

RESULTS: A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms:
P = .834; sports and recreation:
P = .723; work:
P = .541; lifestyle:
P = .508; emotions:
P = .568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group.

CONCLUSION: PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year).

REGISTRATION: NCT02969135 (ClinicalTrials.gov identifier).

Originalsprog Engelsk
Tidsskrift The American journal of sports medicine
Vol/bind 49
Udgave nummer 2
Sider (fra-til) 321-331
Antal sider 11
ISSN 0363-5465
DOI
Status Udgivet - feb. 2021

Knee pain is an early sign of later incident radiographic knee osteoarthritis (OA). However, the prevalence of knee pain in the general population is unknown. Additionally, it is unknown how people with knee pain choose to self-manage the condition and if the perception of the illness affects these choices. In this study, 9086 citizens between 60-69 years old in the municipality of Frederiksberg, Copenhagen, Denmark, were surveyed, of which 4292 responded. The prevalence of knee pain was estimated, and associations between illness perceptions (brief illness perception questionnaire [B-IPQ]), self-management strategies, and knee symptoms were assessed. The prevalence of knee pain was 21.4% of which 40.5% reported to use no self-management strategies (non-users). These non-users perceived their knee pain as less threatening and reported less severe symptoms than users of self-management strategies. Further, we found that a more positive illness perception was associated with less severe knee symptoms. In conclusion, among Danes aged 60-69 years, the knee pain prevalence is 21.4%, of which 40.5% use no treatment and perceive the condition as non-threatening. These non-users with knee pain represent a subpopulation being at increased risk of developing knee OA later in life, and there is a potential preventive gain in identifying these persons.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Medicine
Vol/bind 10
Udgave nummer 4
ISSN 2077-0383
DOI
Status Udgivet - 9 feb. 2021

Evidence-Based Research Series-Paper 1: What Evidence-Based Research is and why is it important?

Robinson, K. A., Brunnhuber, K., Ciliska, D., Juhl, C. B., Christensen, R. & Lund, H., jan. 2021, I: Journal of Clinical Epidemiology. 129, s. 151-157 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: There is considerable actual and potential waste in research. Evidence-based research ensures worthwhile and valuable research. The aim of this series, which this article introduces, is to describe the evidence-based research approach.

STUDY DESIGN AND SETTING: In this first article of a three-article series, we introduce the evidence-based research approach. Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner.

RESULTS: We describe evidence-based research and provide an overview of the approach of systematically and transparently using previous research before starting a new study to justify and design the new study (article #2 in series) and-on study completion-place its results in the context with what is already known (article #3 in series).

CONCLUSION: This series introduces evidence-based research as an approach to minimize unnecessary and irrelevant clinical health research that is unscientific, wasteful, and unethical.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 129
Sider (fra-til) 151-157
Antal sider 7
ISSN 0895-4356
DOI
Status Udgivet - jan. 2021

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

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
Tidsskrift Trials
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 18
ISSN 1745-6215
DOI
Status Udgivet - 6 jan. 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., 5 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 - 5 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.

Knee replacement outcome predicted by physiotherapists: a prospective cohort study

Henriksen, M., Mukriyani, H. & Juhl, C., 2021, I: PeerJ. 9, s. 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
Tidsskrift PeerJ
Vol/bind 9
Sider (fra-til) e10838
ISSN 2167-8359
DOI
Status Udgivet - 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
ISSN 0002-9165
DOI
Status E-pub ahead of print - 20 jan. 2021

Bibliografisk note

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

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
Tidsskrift BMJ open diabetes research & care
Vol/bind 9
Udgave nummer 1
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.

One-year treatment outcomes of secukinumab versus tumor necrosis factor inhibitors in Spondyloarthritis

Glintborg, B., Lindstrom, U., De Giuseppe, D., Provan, S. A., Gudbjornsson, B., Hetland, M. L., Michelsen, B., Wallman, J., Aaltonen, K., Hokkanen, A-M., Nordström, D., Jørgensen, T. S., Hansen, R. L., Jon Geirsson, A., Grøn, K., Krogh, N. S., Askling, J., Kristensen, L. E., Jacobsson, L. & DANBIO (Denmark), ARTIS/SRQ (Sweden), ICEBIO (Iceland), ROB-FIN (Finland), NOR-DMARD (Norway) registries, 2021, (E-pub ahead of print) I: Arthritis Care & Research.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To describe baseline characteristics and to compare treatment effectiveness of secukinumab versus tumor necrosis factor inhibitors (TNFi), in patients with spondyloarthritis (SpA) using adalimumab as the main comparator.

METHODS: Observational, prospective cohort study. Patients with SpA (clinical ankylosing spondylitis/non-radiographic axial SpA/undifferentiated SpA) starting secukinumab or a TNFi during 2015-2018 were identified from five Nordic clinical rheumatology registries. Comorbidities and extra-articular manifestations (psoriasis/uveitis/inflammatory bowel disease) were captured from national registries (data available in 94% of patients) and included in multivariable analyses. We assessed 1-year treatment retention (crude survival curves, adjusted hazard ratios (HR) for treatment discontinuation) and 6-months' response-rates (ASDAS<2.1/BASDAI<40mm, crude/LUNDEX-adjusted, adjusted logistic-regression analyses with odds-ratio(OR)), stratified by line of biological treatment (1st /2nd /3rd +).

RESULTS: In total, 10,853 treatment courses (842 secukinumab/10,011 TNFi whereof 1,977 adalimumab) were included. The proportion treated with secukinumab during 1st /2nd /3rd + was 1%/6%/22%). Extra-articular manifestations varied across treatments, while other baseline characteristics were largely similar. Secukinumab had a one-year retention comparable to adalimumab as 1st or 2nd , but poorer as 3rd + line of therapy (secukinumab 56% (51%-61%) versus adalimumab 70% (64%-75%)), adjusted HR 1.43 (1.12-1.81). Across treatment lines, secukinumab had poorer estimates for 6-months response rates than adalimumab, statistically significantly so only for 3rd + line (adjusted analyses: ASDAS<2.1 OR=0.56 (0.35-0.90), BASDAI<40mm OR=0.62 (0.41-0.95)). Treatment outcomes varied across the five TNFi.

CONCLUSION: Secukinumab was mainly used in biologically experienced SpA patients. Secukinumab and adalimumab performed similar in patients who had failed a first biological, although with increasing prior biological exposure, adalimumab was superior.

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

Bibliografisk note

COPECARE

OBJECTIVES: To investigate biomechanical changes in lumbar disc herniations.

METHODS: Patients with lumbar disc herniation verified on a 1.5-3-T magnetic resonance imaging (MRI) scanner were imaged in a weight-bearing 0.25-T MRI scanner in (1) standing position, (2) conventional supine position with relative lumbar flexion, and (3) supine position with a forced lumbar extension by adding a lumbar pillow. The L2-S1 lordosis angle, the disc cross-sectional area, the disc cross-sectional diameter, and the spinal canal cross-sectional diameter were measured for each position. Disc degeneration and nerve root compression were graded, and the pain intensity was reported during each scan position.

RESULTS: Forty-three herniated discs in 37 patients (36.7 ± 11.9 years) were analyzed in each position. The L2-S1 lumbar angle increased in the standing position (mean difference [MD]: 5.61°, 95% confidence interval [95% CI]: 3.44 to 7.78) and with the lumbar pillow in the supine position (MD: 14.63°, 95% CI: 11.71 to 17.57), both compared with the conventional supine position. The herniated disc cross-sectional area and diameter increased during standing compared with during conventional supine position. No changes were found in the spinal canal cross-sectional diameter between positions. Higher nerve root compression grades for paracentral herniations were found during standing compared with during conventional supine position. This was neither found with a lumbar pillow nor for central herniations in any position compared with conventional supine.

CONCLUSION: Disc herniations displayed dynamic behavior with morphological changes in the standing position, leading to higher nerve root compression grades for paracentral herniated discs.

KEY POINTS: • Lumbar herniated discs increased in size in the axial plane during standing. • Increased nerve root compression grades for paracentral herniated discs were found during standing. • Weight-bearing MRI may increase the diagnostic sensitivity of nerve root compression in lumbar disc herniations.

Originalsprog Engelsk
Tidsskrift European Radiology
Vol/bind 31
Udgave nummer 2
Sider (fra-til) 804-812
Antal sider 9
ISSN 0938-7994
DOI
Status Udgivet - feb. 2021

Predictors of joint damage progression and stringent remission in patients with established rheumatoid arthritis in clinical remission

Møller-Bisgaard, S., Georgiadis, S., Hørslev-Petersen, K., Ejbjerg, B., Hetland, M. L., Ørnbjerg, L. M., Glinatsi, D., Møller, J., Boesen, M., Stengaard-Pedersen, K., Madsen, O. R., Jensen, B., Villadsen, J. A., Hauge, E-M., Bennett, P., Hendricks, O., Asmussen, K., Kowalski, M., Lindegaard, H., Bliddal, H., Krogh, N. S., Ellingsen, T., Nielsen, A. H., Balding, L., Jurik, A. G., Thomsen, H. S. & Østergaard, M., 2021, I: Rheumatology (Oxford, England). 60, 1, s. 380-391

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To study if clinical, radiographic and MRI markers can predict MRI and radiographic damage progression and achievement of stringent remission in patients with established RA in clinical remission followed by a targeted treatment strategy.

METHODS: RA patients (DAS28-CRP <3.2, no swollen joints) receiving conventional synthetic DMARDs were randomized to conventional or MRI-targeted treat-to-target strategies with predefined algorithmic treatment escalations. Potentially predictive baseline variables were tested in multivariate logistic regression analyses.

RESULTS: In the 171 patients included, baseline MRI osteitis independently predicted progression in MRI erosion [odds ratio (OR) 1.13 (95% CI 1.06, 1.22)], joint space narrowing [OR 1.15 (95% CI 1.07, 1.24)] and combined damage [OR 1.23 (95% CI 1.13, 1.37)], while tenosynovitis independently predicted MRI erosion progression [OR 1.13 (95% CI 1.03, 1.25)]. A predictor of radiographic erosion progression was age, while gender predicted progression in joint space narrowing. Following an MRI treat-to-target strategy predicted stringent remission across all remission definitions: Clinical Disease Activity Index remission OR 2.94 (95% CI 1.25, 7.52), Simplified Disease Activity Index remission OR 2.50 (95% CI 1.01, 6.66), ACR/EULAR Boolean remission OR 5.47 (95% CI 2.33, 14.13). Similarly, low tender joint count and low patient visual analogue scale pain and global independently predicted achievement of more stringent remission.

CONCLUSION: Baseline MRI osteitis and tenosynovitis were independent predictors of 2 year MRI damage progression in RA patients in clinical remission, while independent predictors of radiographic damage progression were age and gender. Following an MRI treat-to-target strategy, low scores of patient-reported outcomes and low tender joint count predicted achievement of stringent remission.

TRIAL REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov), NCT01656278.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 60
Udgave nummer 1
Sider (fra-til) 380-391
ISSN 1462-0324
DOI
Status Udgivet - 2021

Bibliografisk note

COPECARE

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

DATA SOURCES: EMBASE, MEDLINE, Cochrane Library, Cinahl, and Pedro were searched from inception to March 2020.

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

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

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

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

Originalsprog Engelsk
Tidsskrift Archives of Physical Medicine and Rehabilitation
ISSN 0003-9993
DOI
Status E-pub ahead of print - 27 apr. 2021

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

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

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

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

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

Bibliografisk note

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