Published in 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.

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 - 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., 21 feb. 2022, (E-pub ahead of print) I: Journal of Sports Medicine and Physical Fitness.

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 one-legged landing balance in the first 400 milliseconds following jump landing compared to noninjured 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
ISSN 0022-4707
DOI
Status E-pub ahead of print - 21 feb. 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 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
Artikelnummer 1
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).

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.

Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II)

Lynggaard, C. D., Grà nhà J, C., Christensen, R., Fischer-Nielsen, A., Melchiors, J., Specht, L., Andersen, E., Mortensen, J., Oturai, P., Barfod, G. H., Haastrup, E. K., Mã Ller-Hansen, M., Haack-Sã Rensen, M., Ekblond, A., Kastrup, J., Jensen, S. B. & von Buchwald, C., 18 apr. 2022, (E-pub ahead of print) I: Stem Cells Translational Medicine.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)âxerostomia. 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 â¨(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 â¨(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
ISSN 2157-6564
DOI
Status E-pub ahead of print - 18 apr. 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 cells (ASC) injections into the submandibular glands.

PATIENTS AND METHODS: A investigator-initiated, randomized, single-center, placebo-controlled trial. Previous oropharyngeal squamous cell carcinoma patients 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 minimally 2 years. The primary endpoint was number of serious adverse events (SAEs). Secondary endpoints included whole saliva flow rates and xerostomia-related symptoms. Data analysis was based on the intention-to-treat (ITT) 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, 6/15 (40%) of the ASC-treated patients versus 5/15 (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/min in the ASC and placebo group, respectively, yielding a 0.05 mL/min (95% CI: 0.00 to 0.10, P=.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=.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

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

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, 2022, (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 - 2022

Bibliografisk note

COPECARE

One-year treatment outcomes of secukinumab versus tumor necrosis factor inhibitors in Spondyloarthritis: Results From Five Nordic Biologic Registries Including More Than 10,000 Treatment Courses

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, maj 2022, I: Arthritis Care & Research. 74, 5, s. 748-758 11 s.

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: This was an observational, prospective cohort study. Patients with SpA (clinical ankylosing spondylitis, nonradiographic axial SpA, or undifferentiated SpA) starting secukinumab or a TNFi during 2015-2018 were identified from 5 Nordic clinical rheumatology registries. Data on comorbidities and extraarticular manifestations (psoriasis, uveitis, and 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
adj ] for treatment discontinuation) and 6-month response rates (Ankylosing Spondylitis Disease Activity Score [ASDAS] score <2.1, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] <40 mm, crude/LUNDEX-adjusted, adjusted logistic regression analyses with odds ratios [ORs]) stratified by line of biologic treatment (first, second, and third plus).

RESULTS: In total, 10,853 treatment courses (842 secukinumab and 10,011 TNFi, of which 1,977 were adalimumab) were included. The proportions of patients treated with secukinumab during the first, second, and third-plus lines of treatment were 1%, 6%, and 22%, respectively). Extraarticular manifestations varied across treatments, while other baseline characteristics were largely similar. Secukinumab had a 1-year retention comparable to adalimumab as a first or second line of treatment but poorer as a third-plus line of therapy (secukinumab 56% [95% confidence interval (95% CI) 51-61%] versus adalimumab 70% [95% CI 64-75%]; HR
adj 1.43 [95% CI 1.12-1.81]). Across treatment lines, secukinumab had poorer estimates for 6-month response rates than adalimumab, statistically significantly only for the third-plus line (adjusted analyses: ASDAS score <2.1 OR 0.56 [95% CI 0.35-0.90]; BASDAI <40 mm OR 0.62 [95% CI 0.41-0.95]). Treatment outcomes varied across the 5 TNFi.

CONCLUSION: Secukinumab was mainly used in biologics-experienced patients with SpA. Secukinumab and adalimumab performed similarly in patients who had failed a first biologic, although with increasing prior biologic exposure, adalimumab was superior.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 74
Udgave nummer 5
Sider (fra-til) 748-758
Antal sider 11
ISSN 2151-464X
DOI
Status Udgivet - maj 2022

Bibliografisk note

COPECARE

Oophorectomy and rate of dementia: a prospective cohort study

Uldbjerg, C. S., Wilson, L. F., Koch, T., Christensen, J., Dehlendorff, C., Priskorn, L., Abildgaard, J., Simonsen, M. K., Lim, Y-H., Jørgensen, J. T., Andersen, Z. J., Juul, A., Hickey, M. & Bräuner, E. V., 1 maj 2022, I: Menopause (New York, N.Y.). 29, 5, s. 514-522 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Globally, dementia disproportionally affects women, which is not fully explained by higher female longevity. Oophorectomy at any age leads to the permanent loss of ovarian sex steroids, potentially increasing the risk of dementia. We aimed to investigate the association between oophorectomy and dementia and whether this was conditional on age at oophorectomy, hysterectomy or use of hormone therapy (HT).

METHODS: A prospective study of 24,851 female nurses from the Danish Nurse Cohort. Nurses were followed from age 60 years or entry into the cohort, whichever came last, until date of dementia, death, emigration or end of follow-up (December 31, 2018), whichever came first. Poisson regression models with log-transformed person-years as offset were used to estimate the associations.

RESULTS: During 334,420 person-years of follow-up, 1,238 (5.0%) nurses developed dementia and 1,969 (7.9%)/1,016 (4.1%) contributed person-time after bilateral-/unilateral oophorectomy. In adjusted analyses, an 18% higher rate of dementia was observed following bilateral oophorectomy (aRR 1.18: 95% CI, 0.89-1.56) and 13% lower rate (aRR 0.87: 95% CI, 0.59-1.23) following unilateral oophorectomy compared to nurses who retained their ovaries. Similar effects were detected after stratification according to age at oophorectomy. No statistically significant modifying effects of hysterectomy or HT were detected (Pinteraction≥0.60).

CONCLUSIONS: Bilateral, but not unilateral, oophorectomy was associated with an increased rate of incident dementia. We were unable to establish whether this association was conditional on hysterectomy or HT use. Although an increase in dementia after bilateral oophorectomy is biologically plausible, limited statistical power hampers the precision of the estimates.

Originalsprog Engelsk
Tidsskrift Menopause (New York, N.Y.)
Vol/bind 29
Udgave nummer 5
Sider (fra-til) 514-522
Antal sider 9
ISSN 1072-3714
DOI
Status Udgivet - 1 maj 2022

Bibliografisk note

Copyright © 2022 by The North American Menopause Society.

Participation and engagement in family activities among girls and young women with Rett syndrome living at home with their parents - a cross-sectional study

Kruse Gyldhof, D., Stahlhut, M. & Waehrens, E. E., 2022, (E-pub ahead of print) I: Disability and Rehabilitation. s. 1-11 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: To describe the extent of participation and engagement in family activities and explore variables potentially impacting on these factors in family activities among girls and young women with Rett syndrome (RTT) under the age of 21.

MATERIALS AND METHODS: The Child Participation in Family Activities (Child-PFA) questionnaire was sent to parents in the target group (n = 42). Additionally, age, number of siblings at home, ambulation level, clinical severity and level of hand function were recorded to explore possible impact. Data were analyzed using descriptive statistics, Fishers exact test and cross-tables.

RESULTS: 23 families participated. Highest degrees of participation and engagement were seen in social and stationary family activities. Indoor activities were frequent and showed high levels of participation and engagement, Outdoor activities were infrequent and showed low levels of participation despite a high degree of engagement. Routine activities were frequent but showed moderate to low participation and engagement. A negative association was found between participation in watching a movie and number of siblings living at home, and positive associations between engagement and age in three family activities.

CONCLUSION: Therapists working with this target group may benefit from focusing on engagement in routine activities and modification of family activities.IMPLICATIONS FOR REHABILITATIONTherapists may benefit from focusing on engagement in routine activities in the goal setting process and intervention as they occur on a daily basis, giving the opportunity for development of new skills.Therapists may benefit from focusing on assistive devices or other compensatory strategies for outdoor activities and activities that require a certain amount of hand function.Therapists may benefit from modifying the family's activities so that they require more social and mental participation and focus on experiencing different types of sensory input e.g., sound, tactile, visual or vestibular input rather than taking part in the activity by using their hands.

Originalsprog Engelsk
Tidsskrift Disability and Rehabilitation
Sider (fra-til) 1-11
Antal sider 11
ISSN 1464-5165
DOI
Status E-pub ahead of print - 2022

Performance of the 2016 diagnostic criteria for fibromyalgia in a tertiary care pain rehabilitation setting: a diagnostic accuracy study

Jensen, H. I., Blichfeldt-Eckhardt, M. R., Vaegter, H. B., Toft, P., Amris, K. & Kvorning, N., 27 jan. 2022, I: Scandinavian Journal of Pain. 22, 1, s. 67-76 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: With the International Classification of Diseases 11th revision (classifying fibromyalgia as a primary pain disorder) soon to be implemented, the importance of pain physicians being able to identify patients with fibromyalgia is emphasized. The diagnostic criteria proposed in 2016 are based on self-reported pain distribution and symptom severity. The study aimed to evaluate the diagnostic accuracy of the 2016 diagnostic criteria for fibromyalgia applied in a population of patients with high impact chronic pain referred for pain rehabilitation.

METHODS: The study was performed as a diagnostic accuracy study at two Danish interdisciplinary pain rehabilitation centers, including 215 participants. All participants were evaluated clinically to identify patients with fibromyalgia. The diagnosis was based on expert opinion, but the minimum requirements were: (1) pain in all four body quadrants and axially for at least three months and (2) minimum 8 of 18 positive tender points. Participants filled in the fibromyalgia survey questionnaire, the patient version of the 2016 diagnostic criteria. Sensitivity, specificity, likelihood ratios, and positive and negative post-test probabilities were calculated using a clinical diagnosis of fibromyalgia as the reference standard.

RESULTS: Based on clinical diagnosis 45% of the participants were diagnosed with fibromyalgia; of these, only 19% had been diagnosed previously. The 2016 diagnostic criteria demonstrated a sensitivity of 88.5%, a specificity of 81.5%, a positive likelihood ratio of 4.79, a negative likelihood ratio of 0.14, a positive post-test probability of 79.4%, and a negative post-test probability of 10.2%.

CONCLUSIONS: Fibromyalgia was severely under-diagnosed among patients with high impact chronic pain referred to tertiary care in two pain rehabilitation centers in Denmark. The 2016 diagnostic criteria showed sufficient discriminatory properties suggesting that the fibromyalgia survey questionnaire can be used as a screening tool assisting the identification of fibromyalgia in this patient population.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Pain
Vol/bind 22
Udgave nummer 1
Sider (fra-til) 67-76
Antal sider 10
ISSN 1877-8860
DOI
Status Udgivet - 27 jan. 2022

Bibliografisk note

© 2021 Walter de Gruyter GmbH, Berlin/Boston.

Physical Activity and Subsequent Change in Body Weight, Composition and Shape: Effect Modification by Familial Overweight

Specht, I. O., Heitmann, B. L. & Larsen, S. C., 2022, I: Frontiers in Endocrinology. 13, s. 787827 787827.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Background: Physical activity (PA) has been shown to attenuate the genetic risk of obesity as measured using polygenic risk scores. However, familial obesity history might be an easier predictor. We examined associations between PA and subsequent changes in BMI, body fat percentage (BF%) and waist circumference (WC) among participants with and without adiposity and a familial overweight.

Methods: In total, 1971 participants from the Danish MONICA cohort were included. Mean differences for 6-year changes in BMI, BF% and WC across PA levels were estimated. Association between walking and biking and subsequent change in adiposity were analysed. Effect modification by familial obesity was assessed by adding product terms to the models.

Results: We observed weak associations between leisure PA level and changes in WC [participants with low PA: 3.4 cm (95%CI: 2.8;4.0), participants with high PA: 2.4 cm (95%CI: 1.8;3.0)], with no evidence of effect modification by familial obesity. We found effect modification in analyses on walking and biking in relation to changes in BMI (P-interaction<0.01) and BF% (P-interaction=0.04), suggesting lower gain with more hours of activity among participants with adiposity and familial overweight.

Conclusions: The results were modest but suggested that PA, especially walking and biking, may prevent future adiposity.

Originalsprog Engelsk
Artikelnummer 787827
Tidsskrift Frontiers in Endocrinology
Vol/bind 13
Sider (fra-til) 787827
ISSN 1664-2392
DOI
Status Udgivet - 2022

Bibliografisk note

Copyright © 2022 Specht, Heitmann and Larsen.

Physiotherapists' prognosis of 1-year outcome after lumbar spinal fusion - A prospective cohort study

Tegner, H., Garval, M., Rolving, N., Esbensen, B. A., Bech-Azeddine, R. & Henriksen, M., 21 feb. 2022, (E-pub ahead of print) I: Physiotherapy Theory and Practice. s. 1-12 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Physiotherapists (PTs) have an essential role in the facilitation of patients' mobilization after lumbar spinal fusion (LSF). The aim of this study is to investigate whether PTs can predict one-year post-surgery outcome based on their first meeting with the patient immediately after LSF.

METHOD: A prospective cohort study with one-year follow-up was conducted. In the first days after surgery, the PTs from hospital wards were asked to predict the patients' overall LSF outcome one year after surgery. One year after surgery, the patients received a questionnaire including the Oswestry Disability Index (ODI), visual analogue scales (VAS) for leg and back pain, quality of life survey (EQ-5D-3 L), global perceived effect (GPA), and satisfaction with surgery outcome (SSO). Univariate and logistic regression were used to calculate the associations between the prognosis and predictive values.

RESULTS: The study included 170 patients. The analyses showed a significant association between the PTs' prognosis and the primary outcome ODI (p < .01), VAS leg and back, EQ-5D-3 L, and GPE one-year post-surgery (p ≤ .04). However, the predictive value of the PTs' prognosis was low (R2 ≤ 0.09). There was no significant association between the PTs' prognosis and the patients' SSO (p = .17; R2 = 0.01).

CONCLUSION: There were significant associations between the PTs' prognosis and disability, pain, health-related quality of life and global perceived effect one-year post-surgery, although the associations had low predictive values. There was no significant association between the PTs' prognosis and patients' SSO after one year. The PTs' prognosis should not be used as a single component in further rehabilitation planning.

Originalsprog Engelsk
Tidsskrift Physiotherapy Theory and Practice
Sider (fra-til) 1-12
Antal sider 12
ISSN 0959-3985
DOI
Status E-pub ahead of print - 21 feb. 2022

Rebozo and External Cephalic Version in breech presentation (RECEIVE): A randomised controlled study

de Wolff, M. G., Ladekarl, M., Sparholt, L. & Lykke, J. A., 3 feb. 2022, (E-pub ahead of print) I: BJOG : an international journal of obstetrics and gynaecology. s. 1-27 27 s., 17111.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To investigate if a hospital-initiated home-based rebozo intervention performed by the pregnant woman and her partner before external cephalic version (ECV) would increase the rate of cephalic presentations at birth.

DESIGN: A multicentre randomised controlled trial.

SETTING: Three university hospitals in Copenhagen, Denmark.

POPULATION: Pregnant women with a breech or transverse presentation at 35 weeks or more of gestation eligible for ECV.

METHODS: We compared rebozo before ECV with ECV alone. The randomisation was computer-generated in blocks and stratified by parity. The woman and her partner were instructed in the technique by a project midwife and performed the technique at home three times daily for 3-5 days before the scheduled ECV. Analyses were by intention-to-treat.

MAIN OUTCOME MEASURE: The number of cephalic presentations at the time of birth. Odds ratios (OR) and 95% confidence intervals (CI) were calculated.

RESULTS: A total of 372 women were randomly assigned (1:1) to either rebozo intervention (n = 187) or control (n = 185). At birth, 95 (51%) in the intervention group versus 112 (62%) in the control group had a fetus in cephalic presentation (OR 0.61; 95% CI 0.40-0.95). No adverse events were observed in relation to the intervention.

CONCLUSIONS: In breech or transverse presentation, home-based rebozo exercise before ECV lowered the overall rate of cephalic presentation at birth.

Originalsprog Engelsk
Artikelnummer 17111
Tidsskrift BJOG : an international journal of obstetrics and gynaecology
Sider (fra-til) 1-27
Antal sider 27
ISSN 1470-0328
DOI
Status E-pub ahead of print - 3 feb. 2022

Bibliografisk note

This article is protected by copyright. All rights reserved.

Rebozo and External Cephalic Version in breech presentation (RECEIVE): a randomized controlled study

de Wolff, M. G., Ladekarl, M., Sparholt, L. & Lykke, J. A., 3 feb. 2022, (E-pub ahead of print) I: BJOG : an international journal of obstetrics and gynaecology. s. 1-27 27 s., 17111.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To investigate if a hospital-initiated home-based rebozo intervention performed by the pregnant woman and her partner before external cephalic version (ECV) would increase the rate of cephalic presentations at birth.

DESIGN: A multicentre randomised controlled trial.

SETTING: Three university hospitals in Copenhagen, Denmark.

POPULATION: Pregnant women with a breech or transverse presentation at 35 weeks or more of gestation eligible for ECV.

METHODS: We compared rebozo before ECV with ECV alone. The randomisation was computer-generated in blocks and stratified by parity. The woman and her partner were instructed in the technique by a project midwife and performed the technique at home three times daily for 3-5 days before the scheduled ECV. Analyses were by intention-to-treat.

MAIN OUTCOME MEASURE: The number of cephalic presentations at the time of birth. Odds ratios (OR) and 95% confidence intervals (CI) were calculated.

RESULTS: A total of 372 women were randomly assigned (1:1) to either rebozo intervention (n = 187) or control (n = 185). At birth, 95 (51%) in the intervention group versus 112 (62%) in the control group had a fetus in cephalic presentation (OR 0.61; 95% CI 0.40-0.95). No adverse events were observed in relation to the intervention.

CONCLUSIONS: In breech or transverse presentation, home-based rebozo exercise before ECV lowered the overall rate of cephalic presentation at birth.

Originalsprog Engelsk
Artikelnummer 17111
Tidsskrift BJOG : an international journal of obstetrics and gynaecology
Sider (fra-til) 1-27
Antal sider 27
ISSN 1470-0328
DOI
Status E-pub ahead of print - 3 feb. 2022

Bibliografisk note

This article is protected by copyright. All rights reserved.

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