Published in 2022

Healthy nutrition for seafarers during and after COVID-19 pandemic

Baygi, F., Mohammadi-Nasrabadi, F., Zyriax, B-C. & Heitmann, B. L., 2022, I: International maritime health. 73, 1, s. 56-57 2 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift International maritime health
Vol/bind 73
Udgave nummer 1
Sider (fra-til) 56-57
Antal sider 2
ISSN 1641-9251
DOI
Status Udgivet - 2022
Originalsprog Engelsk
Tidsskrift The American journal of gastroenterology
Vol/bind 117
Udgave nummer 1
Sider (fra-til) 195-196
Antal sider 2
ISSN 0002-9270
DOI
Status Udgivet - 1 jan. 2022

BACKGROUND: Hyperoxia and oxidative stress may be associated with increased risk of myocardial injury. The authors hypothesized that a perioperative inspiratory oxygen fraction of 0.80 versus 0.30 would increase the degree of myocardial injury within the first 3 days of surgery, and that an antioxidant intervention would reduce degree of myocardial injury versus placebo.

METHODS: A 2 × 2 factorial, randomized, blinded, multicenter trial enrolled patients older than 45 yr who had cardiovascular risk factors undergoing major noncardiac surgery. Factorial randomization allocated patients to one of two oxygen interventions from intubation and at 2 h after surgery, as well as antioxidant intervention or matching placebo. Antioxidants were 3 g IV vitamin C and 100 mg/kg N-acetylcysteine. The primary outcome was the degree of myocardial injury assessed by the area under the curve for high-sensitive troponin within the first 3 postoperative days.

RESULTS: The authors randomized 600 participants from April 2018 to January 2020 and analyzed 576 patients for the primary outcome. Baseline and intraoperative characteristics did not differ between groups. The primary outcome was 35 ng · day/l (19 to 58) in the 80% oxygen group; 35 ng · day/l (17 to 56) in the 30% oxygen group; 35 ng · day/l (19 to 54) in the antioxidants group; and 33 ng · day/l (18 to 57) in the placebo group. The median difference between oxygen groups was 1.5 ng · day/l (95% CI, -2.5 to 5.3; P = 0.202) and -0.5 ng · day/l (95% CI, -4.5 to 3.0; P = 0.228) between antioxidant groups. Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79 [95% CI, 0.214 to 2.99]; P = 0.732 for the antioxidants vs. placebo groups).

CONCLUSIONS: Perioperative interventions with high inspiratory oxygen fraction and antioxidants did not change the degree of myocardial injury within the first 3 days of surgery. This implies safety with 80% oxygen and no cardiovascular benefits of vitamin C and N-acetylcysteine in major noncardiac surgery.

EDITOR’S PERSPECTIVE:

Originalsprog Engelsk
Tidsskrift Anesthesiology
Vol/bind 136
Udgave nummer 3
Sider (fra-til) 408-419
Antal sider 12
ISSN 0003-3022
DOI
Status Udgivet - 1 mar. 2022

Bibliografisk note

Copyright © 2022, the American Society of Anesthesiologists. All Rights Reserved.

OBJECTIVE: Physicians tend to focus on biomedical targets while little is known about issues important to patients. We aimed to identify critical concepts impacting patients with inflammatory bowel disease (IBD).

DESIGN: We performed a survey of patients with IBD in biologic therapy (n=172) and used a validated qualitative method called group concept mapping (GCM) in patient workshops. The survey included 13 questions on attitudes toward symptoms and issues related to IBD. In the eight workshops, patients (n=26) generated statements later clustered into concepts identifying issues impacting a patient's life. Patients ranked the statements.

RESULTS: In the survey, patients' mean age were 40 years (SD 13), 53% were women, and 38% had ulcerative colitis. They identified fatigue (57%) and stool frequency (46%) as the most critical symptoms impacting their daily lives regardless of disease activity. In the GCM workshops with Crohn's disease (n=13) (median age 42 years (IQR 39-51) and 62% were women), 335 statements divided among 10 concepts were generated, and the three most important concepts were 'Positive attitudes', 'Accept and recognition', and 'Sharing knowledge and experiences in life with Crohn's disease'. In the workshops with ulcerative colitis (n=13) (median age 43 years (IQR 36-49) and 69% were women), 408 statements divided into 11 concepts were generated; the most important concepts were 'Take responsibility and control over your life', 'Medication', and 'Everyday life with ulcerative colitis'.

CONCLUSION: Focusing solely on IBD symptoms, patients identified fatigue and stool frequency to impact daily life the most. However, when investigating the disease burden in a broader perspective beyond classic IBD symptoms, patients identified concepts with focus on emotional health to be most important.

TRIAL REGISTRATION: The Copenhagen University Hospital, Herlev and Gentofte approved the questionnaire and methodology (work-zone no: 18015429).

Originalsprog Engelsk
Tidsskrift BMJ Open Gastroenterology
Vol/bind 9
Udgave nummer 1
ISSN 2054-4774
DOI
Status Udgivet - okt. 2022

Bibliografisk note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Impact of fibre and red/processed meat intake on treatment outcomes among patients with chronic inflammatory diseases initiating biological therapy: A prospective cohort study

Overgaard, S. H., Sørensen, S. B., Munk, H. L., Nexøe, A. B., Glerup, H., Henriksen, R. H., Guldmann, T., Pedersen, N., Saboori, S., Hvid, L., Dahlerup, J. F., Hvas, C. L., Jawhara, M., Andersen, K. W., Pedersen, A. K., Nielsen, O. H., Bergenheim, F., Brodersen, J. B., Heitmann, B. L., Halldorsson, T. I., & 6 flereHolmskov, U., Bygum, A., Christensen, R., Kjeldsen, J., Ellingsen, T. & Andersen, V., 2022, I: Frontiers in nutrition. 9, s. 985732

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Biologic disease-modifying drugs have revolutionised the treatment of a number of chronic inflammatory diseases (CID). However, up to 60% of the patients do not have a sufficient response to treatment and there is a need for optimization of treatment strategies.

OBJECTIVE: To investigate if the treatment outcome of biological therapy is associated with the habitual dietary intake of fibre and red/processed meat in patients with a CID.

METHODS: In this multicentre prospective cohort study, we consecutively enrolled 233 adult patients with a diagnosis of Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis (RA), Axial Spondyloarthritis, Psoriatic Arthritis and Psoriasis, for whom biologic therapy was planned, over a 3 year period. Patients with completed baseline food frequency questionnaires were stratified into a high fibre/low red and processed meat exposed group (HFLM) and an unexposed group (low fibre/high red and processed meat intake = LFHM). The primary outcome was the proportion of patients with a clinical response to biologic therapy after 14-16 weeks of treatment.

RESULTS: Of the 193 patients included in our primary analysis, 114 (59%) had a clinical response to biologic therapy. In the HFLM group (N = 64), 41 (64%) patients responded to treatment compared to 73 (56%) in the LFHM group (N = 129), but the difference was not statistically significant (OR: 1.48, 0.72-3.05). For RA patients however, HFLM diet was associated with a more likely clinical response (82% vs. 35%; OR: 9.84, 1.35-71.56).

CONCLUSION: Habitual HFLM intake did not affect the clinical response to biological treatment across CIDs. HFLM diet in RA patients might be associated with better odds for responding to biological treatment, but this would need confirmation in a randomised trial.

TRIAL REGISTRATION: (clinicaltrials.gov), identifier [NCT03173144].

Originalsprog Engelsk
Tidsskrift Frontiers in nutrition
Vol/bind 9
Sider (fra-til) 985732
ISSN 2296-861X
DOI
Status Udgivet - 2022

Bibliografisk note

Copyright © 2022 Overgaard, Sørensen, Munk, Nexøe, Glerup, Henriksen, Guldmann, Pedersen, Saboori, Hvid, Dahlerup, Hvas, Jawhara, Andersen, Pedersen, Nielsen, Bergenheim, Brodersen, Heitmann, Halldorsson, Holmskov, Bygum, Christensen, Kjeldsen, Ellingsen and Andersen.

OBJECTIVE: Patients with inflammatory arthritis have a high risk of sleep disturbances and disorders. The objective was to evaluate the evidence of nonpharmacologic interventions targeting sleep disturbances or disorders in patients with inflammatory arthritis.

METHODS: A systematic search was undertaken from inception to September 8, 2020. We included randomized trials concerning nonpharmacologic interventions applied in adults with inflammatory arthritis and concomitant sleep disturbances or disorders. The primary outcome was the sleep domain, while secondary outcomes were core outcome domains for inflammatory arthritis trials and harms. The Cochrane Risk of Bias tool was applied, and the overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. 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; 3 of these reported improvement in sleep in favor of the nonpharmacologic interventions. The meta-analysis of the sleep domains indicated a large clinical effect of -0.80 (95% confidence interval -1.33, -0.28) in favor of nonpharmacologic interventions targeting sleep disturbances or disorders. The estimate was rated down twice for risk of bias and unexplained inconsistency; this risk was assessed as corresponding to low-quality evidence. None of the secondary core outcomes used in contemporary inflammatory arthritis trials indicated a clinical benefit in favor of nonpharmacologic interventions targeting sleep.

CONCLUSION: Nonpharmacologic interventions targeting sleep disturbances/disorders in patients with inflammatory arthritis 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 - 2022

OBJECTIVE: Patients with inflammatory arthritis have a high risk of sleep disturbances and disorders. The objective was to evaluate the evidence of nonpharmacologic interventions targeting sleep disturbances or disorders in patients with inflammatory arthritis.

METHODS: A systematic search was undertaken from inception to September 8, 2020. We included randomized trials concerning nonpharmacologic interventions applied in adults with inflammatory arthritis and concomitant sleep disturbances or disorders. The primary outcome was the sleep domain, while secondary outcomes were core outcome domains for inflammatory arthritis trials and harms. The Cochrane Risk of Bias tool was applied, and the overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. 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; 3 of these reported improvement in sleep in favor of the nonpharmacologic interventions. The meta-analysis of the sleep domains indicated a large clinical effect of -0.80 (95% confidence interval -1.33, -0.28) in favor of nonpharmacologic interventions targeting sleep disturbances or disorders. The estimate was rated down twice for risk of bias and unexplained inconsistency; this risk was assessed as corresponding to low-quality evidence. None of the secondary core outcomes used in contemporary inflammatory arthritis trials indicated a clinical benefit in favor of nonpharmacologic interventions targeting sleep.

CONCLUSION: Nonpharmacologic interventions targeting sleep disturbances/disorders in patients with inflammatory arthritis 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 - 2022

Impaired one-legged landing balance in young female athletes with previous ankle sprain: a cross-sectional study

Petersen, A. K., Zebis, M. K., Lauridsen, H. B., Hölmich, P., Aagaard, P. & Bencke, J., nov. 2022, I: Journal of Sports Medicine and Physical Fitness. 62, 11, s. 1489-1495 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Ankle sprain is the most common type of sports injury, especially in team sports. Standing and dynamic landing balance, as an indicator of ankle instability, were investigated using varying experimental approaches.

METHODS: In the present cross-sectional study, 81 adolescent female elite handball and football players were divided into two groups based on previous ankle sprain injury (PI) or not (C). At time of test, all players were fully returned to elite-level sport. Subjects were tested during a one-legged landing (OLL) and in a one-legged static standing balance test (OLBT). In the OLL CoP trajectory displacement was calculated in 200 ms time epochs for evaluation of the initial stages of dynamic landing balance. OLBT was evaluated by calculating total displacement of the CoP trajectory.

RESULTS: CoP displacement was greater in PI than C during the first 200 milliseconds epoch after landing (P=0.001, 252 mm [44], vs. 223 mm [28]), respectively) and in the subsequent 200 ms epoch (P=0.021, 72 mm [20], vs. 61 mm [16], respectively). No significant differences between PI and C were observed in time epochs from 400 to 1000 milliseconds or in OLBT.

CONCLUSIONS: Adolescent elite athletes with a history of previous ankle sprain demonstrate impaired OLL balance in the first 400 milliseconds following jump landing compared to non-injured controls. Consequently, although athletes with previous ankle sprain may return to sport, dynamic postural control may not be fully restored. Future prospective studies are needed to decide, if the OLL test could be considered a relevant criterion tool for safe return-to-sport.

Originalsprog Engelsk
Tidsskrift Journal of Sports Medicine and Physical Fitness
Vol/bind 62
Udgave nummer 11
Sider (fra-til) 1489-1495
Antal sider 7
ISSN 0022-4707
DOI
Status Udgivet - nov. 2022

Intake of n-3 LCPUFA and trans-fatty acids is unrelated to development in body mass index and body fat among children

Ren, X., Larsen, S. C., Lauritzen, L., Rohde, J. F., Andersen, L. B., Bugge, A., Jensen, B. W., Specht, I. O. & Heitmann, B. L., 3 jan. 2022, I: BMC Nutrition. 8, 1, s. 1

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The number of children and adolescents with obesity has increased worldwide. Some studies have found an increase in the intake of n-3 long-chain polyunsaturated fatty acid (LCPUFA) to be beneficial for weight and obesity status. The objectives of this study were to examine if intake of trans-fatty acids (TFA) and n-3 LCPUFA at school start was associated with weight and body fat development in the following 3 and 7 years, and if substituting other fats for n-3 LCPUFA in regression models influenced weight and body fat development.

METHODS: A total of 285 children (boys:130, girls:155) were included in this study. Weight, height and skinfold thickness (SF) of children were measured at age 6, 9 and 13 years by trained research personnel. Multivariate linear regression models were used to investigate the associations between n-3 LCPUFA or TFA intake and subsequent changes in body mass index (BMI) or SF. To investigate substitution effects, we constructed regression models including information on n-3 LCPUFA and all other energy given components of the diet, except for the nutrient to be substituted (all other fats and specific subgroups; saturated fatty acids (SFAs), monounsaturated fatty acids (MUFAs) and other polyunsaturated fatty acids (PUFAs)).

RESULTS: No significant associations were observed between intake of TFA or n-3 LCPUFA and changes in BMI and SF. Also, results from regression analysis showed substituting other fats for n-3 LCPUFA did not associate with BMI or SF development.

CONCLUSION: The lack of associations between n-3 LCPUFA and TFA and adiposity suggests that fat composition in the diet does not play a major role in obesity development among school-aged children.

Originalsprog Engelsk
Tidsskrift BMC Nutrition
Vol/bind 8
Udgave nummer 1
Sider (fra-til) 1
DOI
Status Udgivet - 3 jan. 2022

Bibliografisk note

© 2021. The Author(s).

OBJECTIVES: To evaluate the efficacy of intensive smoking cessation interventions (ISCIs) directly compared with shorter interventions (SIs), measured as successful quitting.

METHOD: Medline, Embase, the Cochrane Library and CINAHL were searched on 15 October 2021. Peer-reviewed randomised controlled trials (RCTs) of adult, daily smokers undergoing an ISCI were included. No setting, time or language restrictions were imposed. Risk of bias and quality of evidence was assessed using the Cochrane tool and Grading of Recommendations, Assessment, Development and Evaluation, respectively. Meta-analyses were conducted using a random-effects model.

RESULTS: 17 550 unique articles were identified and 17 RCTs evaluating 9812 smokers were included. 14 studies were conducted in Europe or the USA. The quality of the evidence was assessed as low or moderate. Continuous abstinence was significantly higher in ISCIs in the long term (risk ratio 2.60, 95% CI 1.71-3.97). Direction and magnitude were similar in the short term; however, they were not statistically significant (risk ratio 2.49, 95% CI: 0.94-6.56). When measured as point prevalence, successful quitting was still statistically significant in favour of ISCIs, but lower (long term: 1.64, 1.08-2.47; short term: 1.68, 1.10-2.56). Sensitivity analysis confirmed the robustness of the results.

CONCLUSION: ISCIs are highly effective compared to SIs. This important knowledge should be used to avoid additional morbidity and mortality caused by smoking.

Originalsprog Engelsk
Artikelnummer 220063
Tidsskrift European respiratory review : an official journal of the European Respiratory Society
Vol/bind 31
Udgave nummer 165
DOI
Status Udgivet - 30 sep. 2022

Bibliografisk note

Copyright ©The authors 2022.

Intra-articular therapies: patient preferences and professional practices in European countries

de la Torre-Aboki, J., Uson, J., Pitsillidou, I., Vardanyan, V., Nikiphorou, E., Rodriguez-Garcia, S. C., Castellanos-Moreira, R., Pandit, H., O'Neill, T. W., Doherty, M., Boesen, M., Möller, I., Terslev, L., D'Agostino, M. A., Kampen, W. U., Berenbaum, F., Naredo, E. & Carmona, L., maj 2022, I: Rheumatology International. 42, 5, s. 869-878 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

To assess patient perspective and professional practice of intraarticular therapies (IATs) across Europe, an expert international multidisciplinary panel designed two open web-based surveys: one targeting people who had experienced at least two IATs (44 items); and one targeting health care providers (HCPs) (160 items). Surveys were disseminated via patient and professional associations and social media. A descriptive analysis was performed. The surveys were answered by 200 patients and 186 HCPs from 26 countries, showing that IAT is routinely performed by rheumatologists (97%) and orthopaedic surgeons (89%), with specific training being compulsory in a few countries. The most frequent indications for IAT are arthritis (76%), osteoarthritis (74%), crystal arthritis (71%) and bursitis (70%); the most frequently injected joints are knee (78%) and shoulder (70%); and the most used compounds are glucocorticoids. The majority of HCPs report informing patients about side-effects (73%), benefits (72%), and the nature of the procedure (72%), which coincides with 27% of patients reporting that they had not been informed about benefits or potential complications of IATs; 73% of patients had not been asked whether they wanted an anaesthetic. Few HCPs (10%) obtain written consent (56% get oral consent, being mandatory for 32%), a procedure deemed necessary by 41% of the patients. 50% of patients reported a clear benefit of IAT and 20% experienced complications including pain, impaired mobility, rashes, or swelling. In summary, the practice of IAT is variable across Europe, and although patients perceive it as relatively safe and usually effective procedure, some gaps were identified.

Originalsprog Engelsk
Tidsskrift Rheumatology International
Vol/bind 42
Udgave nummer 5
Sider (fra-til) 869-878
Antal sider 10
ISSN 0172-8172
DOI
Status Udgivet - maj 2022

Bibliografisk note

© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)-xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P = .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P = .017) mL/minute. XQ summary score decreased by 22.6 units (P = .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P = .0013), sticky saliva 23.3 (P = .0015), and swallowing 10.0 (P = .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.

Originalsprog Engelsk
Tidsskrift Stem Cells Translational Medicine
Vol/bind 11
Udgave nummer 5
Sider (fra-til) 478-489
Antal sider 12
ISSN 2157-6564
DOI
Status Udgivet - 27 maj 2022

Bibliografisk note

© The Author(s) 2022. Published by Oxford University Press.

Is Real-world Evidence Really Real?

Kristensen, L. E. & Egeberg, A., feb. 2022, I: Journal of Rheumatology. 49, 2, s. 126-127 2 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 49
Udgave nummer 2
Sider (fra-til) 126-127
Antal sider 2
ISSN 0315-162X
DOI
Status Udgivet - feb. 2022

Ixekizumab Demonstrates Consistent Efficacy Versus Adalimumab in Biologic Disease-Modifying Anti-rheumatic Drug-Naïve Psoriatic Arthritis Patients Regardless of Psoriasis Severity: 52-Week Post Hoc Results from SPIRIT-H2H

Kristensen, L-E., Okada, M., Tillett, W., Leage, S. L., El Baou, C., Sapin, C., Bradley, A. J., Meszaros, G., Dutz, J. P. & de Vlam, K., feb. 2022, I: Rheumatology and Therapy. 9, 1, s. 109-125 17 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Ixekizumab, a selective interleukin-17A antagonist, was compared with adalimumab in the SPIRIT-H2H study (NCT03151551) in patients with psoriatic arthritis (PsA) and concomitant psoriasis. This post hoc analysis reports outcomes to week 52 in patients from SPIRIT-H2H, stratified by baseline psoriasis severity.

METHODS: SPIRIT-H2H was a 52-week, multicenter, randomized, open-label, rater-blinded, parallel-group study of biologic disease-modifying antirheumatic drug (DMARD)-naïve patients (N = 566) with PsA and active psoriasis (≥ 3% body surface area involvement). Patients were randomized to ixekizumab or adalimumab (1:1) with stratification by baseline concomitant use of conventional synthetic DMARDs and psoriasis severity (with/without moderate-to-severe psoriasis). Patients received on-label dosing according to psoriasis severity. The primary endpoint was the proportion of patients simultaneously achieving ≥ 50% improvement in American College of Rheumatology criteria (ACR50) and 100% improvement in Psoriasis Area Severity Index (PASI100) at week 24. Secondary endpoints included musculoskeletal, disease activity (defined by composite indices), skin and nail, quality of life and safety outcomes. In this post hoc analysis, primary and secondary endpoints of SPIRIT-H2H were analyzed by baseline psoriasis severity.

RESULTS: A greater proportion of patients achieved the combined endpoint of ACR50 + PASI100 and PASI100 with ixekizumab compared with adalimumab at weeks 24 and 52, regardless of baseline psoriasis severity. ACR response rates were similar for ixekizumab and adalimumab across both patient subgroups. For musculoskeletal outcomes, similar efficacy was seen for ixekizumab and adalimumab, but ixekizumab showed greater responses for skin outcomes regardless of psoriasis severity. The safety profiles of ixekizumab and adalimumab were consistent between subgroups.

CONCLUSIONS: Regardless of baseline psoriasis severity, ixekizumab demonstrated greater efficacy than adalimumab with respect to simultaneous achievement of ACR50 + PASI100, and showed consistent and sustained efficacy across PsA-related domains. It also demonstrated higher response rates for skin outcomes. These subgroup analyses highlight the efficacy of ixekizumab in patients with PsA irrespective of the severity of concomitant psoriasis.

Originalsprog Engelsk
Tidsskrift Rheumatology and Therapy
Vol/bind 9
Udgave nummer 1
Sider (fra-til) 109-125
Antal sider 17
ISSN 2198-6576
DOI
Status Udgivet - feb. 2022

Bibliografisk note

© 2021. The Author(s).

Long-term exposure to road traffic noise and all-cause and cause-specific mortality: a Danish Nurse Cohort study

Cole-Hunter, T., So, R., Amini, H., Backalarz, C., Brandt, J., Bräuner, E. V., Hertel, O., Jensen, S. S., Jørgensen, J. T., Ketzel, M., Laursen, J. E., Lim, Y-H., Loft, S., Mehta, A., Mortensen, L. H., Simonsen, M. K., Sisgaard, T., Westendorp, R. & Andersen, Z. J., 11 jan. 2022, I: Science of the Total Environment. 820, 10 s., 153057.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Long-term road traffic noise exposure is linked to cardio-metabolic disease morbidity, whereas evidence on mortality remains limited.

OBJECTIVES: We investigated association of long-term exposure to road traffic noise with all-cause and cause-specific mortality.

METHODS: We linked 22,858 females from the Danish Nurse Cohort (DNC), recruited into the Danish Register of Causes of Death up to 2014. Road traffic noise levels since 1970 were modelled by Nord2000 as the annual mean of a weighted 24 h average (Lden). Cox regression models examined the associations between Lden (5-year and 23-year means) and all-cause and cause-specific mortalities, adjusting for lifestyle and exposure to PM2.5 (particulate matter with diameter < 2.5 μm) and NO2 (nitrogen dioxide).

RESULTS: During follow-up (mean 17.4 years), 3902 nurses died: 1622 from cancer, 922 from CVDs (289 from stroke), 338 from respiratory diseases (186 from chronic obstructive pulmonary disease, 114 from lower respiratory tract infections [ALRIs]), 234 from dementia, 95 from psychiatric disorders, and 79 from diabetes. Hazard ratios (95% confidence intervals) for all-cause mortality from fully-adjusted models were 1.06 (1.01, 1.11) and 1.09 (1.03, 1.15) per 10 dB of 5-year and 23-year mean Lden, respectively, which attenuated slightly in our main model (fully-adjusted plus PM2.5: 1.04 [1.00, 1.10]; 1.08 [1.02, 1.13]). Main model estimates suggested the strongest associations between 5-year mean Lden and diabetes (1.14: 0.81, 1.61), ALRIs (1.13: 0.84, 1.54), dementia (1.12: 0.90, 1.38), and stroke (1.10: 0.91, 1.31), whereas associations with 23-year mean Lden were suggested for respiratory diseases (1.15: 0.95, 1.39), psychiatric disorders (1.11: 0.78, 1.59), and all cancers (1.08: 0.99, 1.17).

DISCUSSION: Among the female nurses from the DNC, we observed that long-term exposure to road traffic noise led to premature mortality, independently of air pollution, and its adverse effects may extend well beyond those on the cardio-metabolic system to include respiratory diseases, cancer, neurodegenerative and psychiatric disorders.

Originalsprog Engelsk
Artikelnummer 153057
Tidsskrift Science of the Total Environment
Vol/bind 820
Antal sider 10
ISSN 0048-9697
DOI
Status Udgivet - 11 jan. 2022

Bibliografisk note

Copyright © 2021. Published by Elsevier B.V.

PURPOSE: Mesenchymal stem/stromal cell therapy may reduce radiation-induced xerostomia. We investigated the long-term safety of autologous adipose tissue-derived mesenchymal stem/stromal cell (ASC) injections into the submandibular glands.

EXPERIMENTAL DESIGN: An investigator-initiated, randomized, single-center, placebo-controlled trial. Previous patients with oropharyngeal squamous cell carcinoma with radiation-induced xerostomia were randomly (1:1) allocated to receive a 2.8 million ASCs/cm3 injection or placebo in both submandibular glands and followed for a minimum of 2 years. The primary endpoint was number of serious adverse events (SAE). Secondary endpoints included whole saliva flow rates and xerostomia-related symptoms. Data analysis was based on the intention-to-treat population using repeated measures mixed-effects linear models.

RESULTS: Thirty-three patients were randomized; 30 patients were treated (ASC group, n = 15; placebo group, n = 15). Long-term safety data were collected from all 30 patients. During follow-up, 6 of 15 (40%) of the ASC-treated patients versus 5 of 15 (33%) of the placebo patients experienced an SAE; no SAEs appeared to be treatment related. Unstimulated whole saliva flow rate increased to 0.20 and 0.16 mL/minute in the ASC and placebo group, respectively, yielding a 0.05 mL/minute (95% confidence interval: 0.00-0.10; P = 0.051) difference between groups. Patient-reported xerostomia symptoms diminished according to a decreased xerostomia questionnaire summary score of 35.0 and 45.1, respectively [-10.1 (-18.1 to -2.2); P = 0.013]. Three of the visual analog scale xerostomia measures indicated clinical benefit following use of ASC.

CONCLUSIONS: Our data show that ASC therapy is safe with a clinically relevant effect on xerostomia-related symptoms. Confirmation in larger randomized controlled trials is warranted.

Originalsprog Engelsk
Tidsskrift Clinical Cancer Research
ISSN 1078-0432
DOI
Status E-pub ahead of print - 29 apr. 2022

PURPOSE: Mesenchymal stem/stromal cell therapy may reduce radiation-induced xerostomia. We investigated the long-term safety of autologous adipose tissue-derived mesenchymal stem/stromal cell (ASC) injections into the submandibular glands.

EXPERIMENTAL DESIGN: An investigator-initiated, randomized, single-center, placebo-controlled trial. Previous patients with oropharyngeal squamous cell carcinoma with radiation-induced xerostomia were randomly (1:1) allocated to receive a 2.8 million ASCs/cm3 injection or placebo in both submandibular glands and followed for a minimum of 2 years. The primary endpoint was number of serious adverse events (SAE). Secondary endpoints included whole saliva flow rates and xerostomia-related symptoms. Data analysis was based on the intention-to-treat population using repeated measures mixed-effects linear models.

RESULTS: Thirty-three patients were randomized; 30 patients were treated (ASC group, n = 15; placebo group, n = 15). Long-term safety data were collected from all 30 patients. During follow-up, 6 of 15 (40%) of the ASC-treated patients versus 5 of 15 (33%) of the placebo patients experienced an SAE; no SAEs appeared to be treatment related. Unstimulated whole saliva flow rate increased to 0.20 and 0.16 mL/minute in the ASC and placebo group, respectively, yielding a 0.05 mL/minute (95% confidence interval: 0.00-0.10; P = 0.051) difference between groups. Patient-reported xerostomia symptoms diminished according to a decreased xerostomia questionnaire summary score of 35.0 and 45.1, respectively [-10.1 (-18.1 to -2.2); P = 0.013]. Three of the visual analog scale xerostomia measures indicated clinical benefit following use of ASC.

CONCLUSIONS: Our data show that ASC therapy is safe with a clinically relevant effect on xerostomia-related symptoms. Confirmation in larger randomized controlled trials is warranted.

Originalsprog Engelsk
Tidsskrift Clinical Cancer Research
Vol/bind 28
Udgave nummer 13
Sider (fra-til) 2890-2897
Antal sider 8
ISSN 1078-0432
DOI
Status Udgivet - 1 jul. 2022

Maintenance of cardiorespiratory fitness, body composition, and a physically active lifestyle after structured exercise interventions in individuals with overweight and obesity: A mixed-method follow-up study

Quist, J. S., Winther, J., Friis, A. L., Gram, A. S., Blond, M. B., Rosenkilde, M., Jespersen, A. P. & Stallknecht, B. M., dec. 2022, I: Public Health in Practice. 4, 100293.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Objectives: The aim of this mixed-method study was to explore maintenance of physical activity and health effects one year after completion of exercise interventions in transport and leisure-time domains of everyday life. We hypothesised that routinisation of active commuting would lead to better maintenance of physical activity and health effects compared with leisure-time exercise. Study design: Mixed-methods follow-up study. Methods: Individuals with overweight/obesity, who completed a 6-month exercise intervention (active commuting by bike (BIKE), moderate (MOD) or vigorous intensity leisure-time exercise (VIG)), were after one year invited to participate in a follow-up visit which included measurements of cardiorespiratory fitness during an incremental bicycle test and body composition using dual-energy X-ray absorptiometry. Variability in maintenance practices was assessed in a sub-sample of participants who experienced the greatest improvements (‘VO2peak improvers’) and reductions (‘VO2peak reducers’), respectively, in cardiorespiratory fitness. Semi-structured interviews were conducted (15–30 min) and analysed using systematic text condensation to identify barriers and facilitators associated with maintenance of physical activity. Results: Out of the 74 participants completing an exercise intervention, 46 (62%) completed follow-up (BIKE: n = 14; MOD: n = 14; VIG: n = 18). Improvements in VO2peak and reductions in fat mass were maintained in BIKE and VIG. Body weight decreased in BIKE and fat free mass increased in VIG. Changes in VO2peak and anthropometry at follow-up did not differ between BIKE and MOD + VIG. Fat mass decreased and recreational physical activity increased in ‘VO2peak improvers’. Findings from the interviews suggested that self-monitoring, collective exercising, and new personal exercise challenges facilitate maintenance of a physically active lifestyle. Conclusion: Completion of a structured exercise intervention consisting of 6 months of active commuting or vigorous intensity leisure-time exercise was associated with long-term maintenance of improvements in VO2peak and body composition, whereas moderate intensity leisure-time exercise was not. In contrast to our hypothesis, active commuting was not associated with better maintenance of physical activity and health effects after the intervention compared with leisure-time exercise.

Originalsprog Engelsk
Artikelnummer 100293
Tidsskrift Public Health in Practice
Vol/bind 4
DOI
Status Udgivet - dec. 2022

Bibliografisk note

Funding Information:
The study was funded by the University of Copenhagen Excellence Programme for Interdisciplinary Research ( www.go.ku.dk ), TrygFonden , and Gerda and Aage Haensch's Fund . The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Jonas Salling Quist was supported by a PhD scholarship from the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark .

Publisher Copyright:
© 2022 The Authors

Meta-research evaluating redundancy and use of systematic reviews when planning new studies in health research: a scoping review

Lund, H., Robinson, K. A., Gjerland, A., Nykvist, H., Drachen, T. M., Christensen, R., Juhl, C. B., Jamtvedt, G., Nortvedt, M., Bjerrum, M., Westmore, M., Yost, J., Brunnhuber, K. & Evidence-Based Research Network, 15 nov. 2022, I: Systematic Reviews. 11, 1, s. 241

Publikation: Bidrag til tidsskriftReviewpeer review

BACKGROUND: Several studies have documented the production of wasteful research, defined as research of no scientific importance and/or not meeting societal needs. We argue that this redundancy in research may to a large degree be due to the lack of a systematic evaluation of the best available evidence and/or of studies assessing societal needs.

OBJECTIVES: The aim of this scoping review is to (A) identify meta-research studies evaluating if redundancy is present within biomedical research, and if so, assessing the prevalence of such redundancy, and (B) to identify meta-research studies evaluating if researchers had been trying to minimise or avoid redundancy.

ELIGIBILITY CRITERIA: Meta-research studies (empirical studies) were eligible if they evaluated whether redundancy was present and to what degree; whether health researchers referred to all earlier similar studies when justifying and designing a new study and/or when placing new results in the context of earlier similar trials; and whether health researchers systematically and transparently considered end users' perspectives when justifying and designing a new study.

SOURCES OF EVIDENCE: The initial overall search was conducted in MEDLINE, Embase via Ovid, CINAHL, Web of Science, Social Sciences Citation Index, Arts & Humanities Citation Index, and the Cochrane Methodology Register from inception to June 2015. A 2nd search included MEDLINE and Embase via Ovid and covered January 2015 to 26 May 2021. No publication date or language restrictions were applied.

CHARTING METHODS: Charting methods included description of the included studies, bibliometric mapping, and presentation of possible research gaps in the identified meta-research.

RESULTS: We identified 69 meta-research studies. Thirty-four (49%) of these evaluated the prevalence of redundancy and 42 (61%) studies evaluated the prevalence of a systematic and transparent use of earlier similar studies when justifying and designing new studies, and/or when placing new results in context, with seven (10%) studies addressing both aspects. Only one (1%) study assessed if the perspectives of end users had been used to inform the justification and design of a new study. Among the included meta-research studies evaluating whether redundancy was present, only two of nine health domains (medical areas) and only two of 10 research topics (different methodological types) were represented. Similarly, among the included meta-research studies evaluating whether researchers had been trying to minimise or avoid redundancy, only one of nine health domains and only one of 10 research topics were represented.

CONCLUSIONS THAT RELATE TO THE REVIEW QUESTIONS AND OBJECTIVES: Even with 69 included meta-research studies, there was a lack of information for most health domains and research topics. However, as most included studies were evaluating across different domains, there is a clear indication of a high prevalence of redundancy and a low prevalence of trying to minimise or avoid redundancy. In addition, only one meta-research study evaluated whether the perspectives of end users were used to inform the justification and design of a new study.

SYSTEMATIC REVIEW REGISTRATION: Protocol registered at Open Science Framework: https://osf.io/3rdua/ (15 June 2021).

Originalsprog Engelsk
Tidsskrift Systematic Reviews
Vol/bind 11
Udgave nummer 1
Sider (fra-til) 241
ISSN 2046-4053
DOI
Status Udgivet - 15 nov. 2022

Bibliografisk note

© 2022. The Author(s).

Minor effect of patient education for alcohol cessation intervention on outcomes after acute fracture surgery: a randomized trial of 70 patients

Egholm, J. W. M., Pedersen, B., Oppedal, K., Madsen, B. L., Lauritzen, J. B., Rasmussen, M., Helander, A., Adami, J. & Tønnesen, H., 12 apr. 2022, I: Acta Orthopaedica . 93, s. 424-431 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND AND PURPOSE: High alcohol intake is associated with increased risk of postoperative complications. Alcohol cessation intervention is recommended prior to elective surgery. We investigated short- and long-term effects of perioperative intensive alcohol intervention in relation to acute ankle fracture surgery.

PATIENTS AND METHODS: 70 patients requiring ankle fracture surgery and consuming ≥ 21 drinks weekly (1 drink = 12 g ethanol) were randomized to a manual-based 6-week intensive standardized alcohol cessation program, the Gold Standard Program (GSP-A), or treatment as usual (TAU), on the day of operation. GSP-A included 5 personal meetings, patient education, and motivational and pharmacological support (alcohol withdrawal prophylaxis, B vitamins, and low-dose disulfiram). Complications requiring treatment were measured after 6 weeks and 1 year. Alcohol intake was validated by biomarkers. Quality of life (QoL) was measured by the SF-36. Hospital costs were obtained from the National Hospital Costs Register.

RESULTS: Postoperatively, complete alcohol cessation was higher in the GSP-A than in the TAU group (18/35 vs. 5/35, number needed to treat = 3, p ≤ 0.001), but not lowrisk consumption in the long term (10/35 vs. 7/33, p = 0.5). Number of complications in the short and long term (12/35 vs. 14/33, 16/35 vs. 18/33), the SF-36 score, or hospital costs in the short and long term (€6,294 vs. €8,024, €10,662 vs. €12,198), were similar between the groups.

INTERPRETATION: Despite an effect on alcohol cessation and a positive tendency as regards the other outcomes, the postoperative complications, QoL, and costs were similar. Better perioperative strategies for acute surgical patients with high alcohol intake therefore need to be developed.

Originalsprog Engelsk
Tidsskrift Acta Orthopaedica
Vol/bind 93
Sider (fra-til) 424-431
Antal sider 8
ISSN 1745-3674
DOI
Status Udgivet - 12 apr. 2022

Pages