Published in 2017

OBJECTIVES: To analyze if exercise interventions for patients with knee osteoarthritis (OA) following the American College of Sports Medicine (ACSM) definition of muscle strength training differs from other types of exercise, and to analyze associations between changes in muscle strength, pain, and disability.

METHODS: A systematic search in 5 electronic databases was performed to identify randomized controlled trials comparing exercise interventions with no intervention in knee OA, and reporting changes in muscle strength and in pain or disability assessed as standardized mean differences (SMD) with 95% confidence intervals (95% CI). Interventions were categorized as ACSM interventions or not-ACSM interventions and compared using stratified random effects meta-analysis models. Associations between knee extensor strength gain and changes in pain/disability were assessed using meta-regression analyses.

RESULTS: The 45 eligible trials with 4699 participants and 56 comparisons (22 ACSM interventions) were included in this analysis. A statistically significant difference favoring the ACSM interventions with respect to knee extensor strength was found [SMD difference: 0.448 (95% CI: 0.091-0.805)]. No differences were observed regarding effects on pain and disability. The meta-regressions indicated that increases in knee extensor strength of 30-40% would be necessary for a likely concomitant beneficial effect on pain and disability, respectively.

CONCLUSION: Exercise interventions following the ACSM criteria for strength training provide superior outcomes in knee extensor strength but not in pain or disability. An increase of less than 30% in knee extensor strength is not likely to be clinically beneficial in terms of changes in pain and disability (PROSPERO: CRD42014015344).

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 47
Tidsskriftsnummer 1
Sider (fra-til) 9-21
ISSN 0049-0172
DOI
Status Udgivet - aug. 2017

The Use of Acoustic MyoGraphy as a Measure of Training Effects in Athletes: A 10 Month Case Study of a BMX Rider

Bartels, E. M., Harder, A., Salomons Heide, K., Pingel, J., Torp Andersen, I. & Harrison, A. P. 2017 I : Annals of Sports Medicine and Research. 4, 1, 1101

Publikation: Forskning - peer reviewTidsskriftartikel

Originalsprog Engelsk
Artikelnummer 1101
Tidsskrift Annals of Sports Medicine and Research
Vol/bind 4
Tidsskriftsnummer 1
Status Udgivet - 2017

Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial

Ingwersen, K. G., Jensen, S. L., Sørensen, L., Jørgensen, H. R., Christensen, R., Søgaard, K. & Juul-Kristensen, B. aug. 2017 I : Orthopaedic Journal of Sports Medicine. 5, 8, s. 2325967117723292

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Progressive high-load exercise (PHLE) has led to positive clinical results in patients with patellar and Achilles tendinopathy. However, its effects on rotator cuff tendinopathy still need to be investigated.

PURPOSE: To assess the clinical effects of PHLE versus low-load exercise (LLE) among patients with rotator cuff tendinopathy.

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

METHODS: Patients with rotator cuff tendinopathy were recruited and randomized to 12 weeks of PHLE or LLE, stratified for concomitant administration of corticosteroid injection. The primary outcome measure was change from baseline to 12 weeks in the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, assessed in the intention-to-treat population.

RESULTS: A total of 100 patients were randomized to PHLE (n = 49) or LLE (n = 51). Mean changes in the DASH questionnaire were 7.11 points (95% CI, 3.07-11.16) and 8.39 points (95% CI, 4.35-12.44) in the PHLE and LLE groups, respectively; this corresponded to a statistically nonsignificant adjusted mean group difference of -1.37 points (95% CI, -6.72 to 3.99; P = .61). Similar nonsignificant results were seen for pain, range of motion, and strength. However, a significant interaction effect was found between the 2 groups and concomitant corticosteroid use (P = .028), with the largest positive change in DASH in favor of PHLE for the group receiving concomitant corticosteroid.

CONCLUSION: The study results showed no superior benefit from PHLE over traditional LLE among patients with rotator cuff tendinopathy. Further investigation of the possible interaction between exercise type and corticosteroid injection is needed to establish optimal and potentially synergistic combinations of these 2 factors.

REGISTRATION: NCT01984203 (ClinicalTrials.gov identifier): Rotator Cuff Tendinopathy Exercise Trial (RoCTEx).

Originalsprog Engelsk
Tidsskrift Orthopaedic Journal of Sports Medicine
Vol/bind 5
Tidsskriftsnummer 8
Sider (fra-til) 2325967117723292
ISSN 2325-9671
DOI
Status Udgivet - aug. 2017

Toward the Development of a Core Set of Outcome Domains to Assess Shared Decision-making Interventions in Rheumatology: Results from an OMERACT Delphi Survey and Consensus Meeting

Toupin-April, K., Barton, J., Fraenkel, L., Li, L. C., Brooks, P., De Wit, M., Stacey, D., Légaré, F., Meara, A., Shea, B., Lyddiatt, A., Hofstetter, C., Gossec, L., Christensen, R., Scholte-Voshaar, M., Suarez-Almazor, M. E., Boonen, A., Meade, T., March, L., Pohl, C., Jull, J. E., Sivarajah, S., Campbell, W., Alten, R., Karuranga, S., Morgan, E., Kaufman, J., Hill, S., Maxwell, L. J., Welch, V., Beaton, D., El-Miedany, Y. & Tugwell, P. S. okt. 2017 I : Journal of Rheumatology. 44, 10, s. 1544-1550 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials.

METHODS: Following the OMERACT Filter 2.0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus on the draft core set.

RESULTS: A total of 170 participants completed Round 1 of the Delphi survey, and 116 completed Round 2. Respondents came from 29 countries, with 49% being patients/caregivers. Results showed that 14 out of the 17 subdomains within the 7 domains exceeded the 70% criterion (endorsement ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016 (endorsement ranged from 17% to 68% of participants).

CONCLUSION: Differences between the Delphi survey and consensus meeting may be explained by the manner in which the outcomes were presented, variations in participant characteristics, and the context of voting. Further efforts are needed to address the limited understanding of SDM and its outcomes among OMERACT participants.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 44
Tidsskriftsnummer 10
Sider (fra-til) 1544-1550
Antal sider 7
ISSN 0315-162X
DOI
Status Udgivet - okt. 2017

Tumour necrosis factor inhibitor treatment and occurrence of anterior uveitis in ankylosing spondylitis: results from the Swedish biologics register

Lie, E., Lindström, U., Zverkova-Sandström, T., Olsen, I. C., Forsblad-d'Elia, H., Askling, J., Kapetanovic, M. C., Kristensen, L. E. & Jacobsson, L. T. H. sep. 2017 I : Annals of the Rheumatic Diseases. 76, 9, s. 1515-1521 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: Tumour necrosis factor-α inhibitor (TNFi) treatment has been shown to reduce the rates of anterior uveitis (AU) in patients with ankylosing spondylitis (AS). Our objective was to compare the effect of adalimumab (ADA), etanercept (ETN) and infliximab (IFX) on AU occurrence in AS, using real-world data.

METHODS: Patients with AS starting ADA, ETN or IFX as their first TNFi from January 2003 to December 2010 were extracted from the Swedish Rheumatology Quality Register. AU rates, based on visits to an ophthalmologist with International Classification of Diseases 10 codes for AU, were obtained by linkage to the Swedish National Patient Register. For each TNFi, AU rates 2 years before TNFi start and for the first 2 years on TNFi treatment were compared. In the subgroup of patients who were AU-free during the 2 years before TNFi start, we also compared the risk of a first AU event.

RESULTS: 1365 patients with AS were included (406 ADA, 354 ETN, 605 IFX). Compared with pretreatment rates, we noted a reduction in overall AU rates for ADA and IFX, and an increase for ETN. The adjusted HRs for AU in 1127 patients who were free of AU in the last 2 years before TNFi start were significantly higher for ETN versus ADA (HR: 3.86 95% CI 1.85 to 8.06) and ETN versus IFX (HR: 1.99, 95% CI 1.23 to 3.22), while the HR for IFX versus ADA was not statistically significant.

CONCLUSIONS: The results suggest differences in effect on AU risk between ADA, ETN and IFX, with a clear advantage for ADA/IFX over ETN.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 76
Tidsskriftsnummer 9
Sider (fra-til) 1515-1521
Antal sider 7
ISSN 0003-4967
DOI
Status Udgivet - sep. 2017
Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 76
Tidsskriftsnummer Suppl 2
Sider (fra-til) 737-738
Antal sider 2
ISSN 0003-4967
Status Udgivet - 2017

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016

Orbai, A-M., de Wit, M., Mease, P. J., Callis Duffin, K., Elmamoun, M., Tillett, W., Campbell, W., FitzGerald, O., Gladman, D. D., Goel, N., Gossec, L., Hoejgaard, P., Leung, Y. Y., Lindsay, C., Strand, V., van der Heijde, D. M., Shea, B., Christensen, R., Coates, L., Eder, L., McHugh, N., Kalyoncu, U., Steinkoenig, I. & Ogdie, A. okt. 2017 I : Journal of Rheumatology. 44, 10, s. 1522-1528 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS).

METHODS: At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants.

RESULTS: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda.

CONCLUSION: The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 44
Tidsskriftsnummer 10
Sider (fra-til) 1522-1528
Antal sider 7
ISSN 0315-162X
DOI
Status Udgivet - okt. 2017

Validity and completeness of rheumatoid arthritis diagnoses in the nationwide DANBIO clinical register and the Danish National Patient Registry

Ibfelt, E. H., Sørensen, J., Jensen, D. V., Dreyer, L., Schiøttz-Christensen, B., Thygesen, P. H., Colic, A., Raun, J. L., Manilo, N., Rødgaard, A., Poulsen, U. E., Rasmussen, C., Hansen, T., Unger, B., Pelck, R., Kincses, A., Nordin, H., Lorenzen, T., Theibich, A., Jensen Hansen, I. M., Espesen, J., Grydehøj, J., Holland-Fischer, M., Loft, A. G. & Hetland, M. L. 2017 I : Clinical Epidemiology. 9, s. 627-632 6 s.

Publikation: Forskning - peer reviewTidsskriftartikel

Objectives: In Denmark, patients with rheumatoid arthritis (RA) are registered in the nationwide clinical DANBIO quality register and the Danish National Patient Registry (DNPR). The aim was to study the validity of the RA diagnosis and to estimate the completeness of relevant RA cases in each registry.

Study design and setting: Patients registered for the first time in 2011 with a diagnosis of RA were identified in DANBIO and DNPR in January 2013. For DNPR, filters were applied to reduce false-positive cases. The diagnosis was verified by a review of patient records. We calculated the positive predictive values (PPVs) of the RA diagnosis registrations in DANBIO and DNPR, and estimated the registry completeness of relevant RA cases for both DANBIO and DNPR. Updated data from 2011 to 2015 from DANBIO were retrieved to identify patients with delayed registration, and the registry completeness and PPV was recalculated.

Results: We identified 1,678 unique patients in DANBIO or in DNPR. The PPV (2013 dataset) was 92% in DANBIO and 79% in DNPR. PPV for DANBIO on the 2015 update was 96%. The registry completeness of relevant RA cases was 43% in DANBIO, increasing to 91% in the 2015 update and 90% in DNPR.

Conclusion: DANBIO held a high proportion of true RA cases (96%) and was found to be superior to the DNPR (79%) with regard to the validity of the diagnosis. Both registries were estimated to have a high completeness of RA cases treated in hospital care (~90%).

Originalsprog Engelsk
Tidsskrift Clinical Epidemiology
Vol/bind 9
Sider (fra-til) 627-632
Antal sider 6
ISSN 1179-1349
DOI
Status Udgivet - 2017

OBJECTIVES: Weight loss is commonly recommended for gout, but the magnitude of the effect has not been evaluated in a systematic review. The aim of this systematic review was to determine benefits and harms associated with weight loss in overweight and obese patients with gout.

METHODS: We searched six databases for longitudinal studies, reporting the effect of weight loss in overweight/obese gout patients. Risk of bias was assessed using the tool Risk of Bias in Non-Randomised Studies of Interventions. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation.

RESULTS: From 3991 potentially eligible studies, 10 were included (including one randomised trial). Interventions included diet with/without physical activity, bariatric surgery, diuretics, metformin or no intervention. Mean weight losses ranged from 3 kg to 34 kg. Clinical heterogeneity in study characteristics precluded meta-analysis. The effect on serum uric acid (sUA) ranged from -168 to 30 μmol/L, and 0%-60% patients achieving sUA target (<360 μmol/L). Six out of eight studies (75%) showed beneficial effects on gout attacks. Two studies indicated dose-response relationship for sUA, achieving sUA target and gout attacks. At short term, temporary increased sUA and gout attacks tended to occur after bariatric surgery.

CONCLUSIONS: The available evidence is in favour of weight loss for overweight/obese gout patients, with low, moderate and low quality of evidence for effects on sUA, achieving sUA target and gout attacks, respectively. At short term, unfavourable effects may occur. Since the current evidence consists of a few studies (mostly observational) of low methodological quality, there is an urgent need to initiate rigorous prospective studies (preferably randomised controlled trials).

SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42016037937.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
ISSN 0003-4967
DOI
Status Udgivet - 2 sep. 2017

Work Disability in Newly Diagnosed Patients with Primary Sjögren Syndrome

Mandl, T., Jørgensen, T. S., Skougaard, M., Olsson, P. & Kristensen, L-E. feb. 2017 I : Journal of Rheumatology. 44, 2, s. 209-215 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To study longterm work disability and possible predictors in newly diagnosed patients with primary Sjögren syndrome (pSS).

METHODS: Because we wanted to include only patients with full work availability potential, eligible patients were aged 18-62 years. Fifty-one patients (mean age 46 yrs, range 18-61 yrs, 50 women) diagnosed with pSS between January 2001 and December 2012 were included in the study. For each patient we randomly selected 4 reference subjects from the general population and matched for age, sex, and area of residence. We linked data to the Swedish Social Insurance Agency and calculated the proportion as well as net days of work disability in 30-day intervals from 12 months before pSS diagnosis until 24 months after .

RESULTS: Work disability was increased in patients with pSS in comparison to general population comparators. At diagnosis, 26% of patients were work-disabled, while 37% and 41% were disabled at 12 and 24 months after diagnosis, respectively (p < 0.05 and p < 0.05 vs baseline). Prior work disability status at diagnosis (OR 15.4, 95% CI 2.9-81.9; p = 0.001), concomitant fibromyalgia (OR 10.5, 95% CI 2.0-56.0; p = 0.006), and each additional year of age (OR 1.1, 95% CI 1.0-1.2; p = 0.009) were found to be associated with work disability 24 months after diagnosis.

CONCLUSION: Patients with pSS showed an increased work disability, in comparison with the general population, which increased significantly during the first 2 years after diagnosis. Work disability at diagnosis, concomitant fibromyalgia, and increasing age, but not anti-SSA/anti-SSB antibodies or disease activity, were associated with longterm work disability.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 44
Tidsskriftsnummer 2
Sider (fra-til) 209-215
Antal sider 7
ISSN 0315-162X
DOI
Status Udgivet - feb. 2017

Work disability in non-radiographic axial spondyloarthritis patients before and after start of anti-TNF therapy: a population-based regional cohort study from southern Sweden

Wallman, J. K., Jöud, A., Olofsson, T., Jacobsson, L. T. H., Bliddal, H. & Kristensen, L. E. 1 maj 2017 I : Rheumatology (Oxford, England). 56, 5, s. 716-724 9 s.

Publikation: Forskning - peer reviewTidsskriftartikel

Objective.: The aim was to assess work-loss days before and after commencement of anti-TNF treatment in patients with non-radiographic axial spondylarthritis (nr-axSpA).

Methods.: Bionaïve nr-axSpA patients (n = 75), aged 17-62 years, fulfilling the Assessment of SpondyloArthritis international Society criteria for axial spondyloarthritis and starting anti-TNF treatment during 2004-11, were retrieved from the observational South Swedish Arthritis Treatment Group study. Patient information was linked to Swedish Social Insurance Agency data on sick leave and disability pension from 1 year before to 2 years after anti-TNF initiation. Matched population references were included for comparison and to adjust for secular trends.

Results.: The nr-axSpA patients had a median age of 35 years and disease duration of 6 years at the start of treatment. During the 2 years after anti-TNF initiation, mean work-loss days (including both sick leave and disability pension) in the nr-axSpA group decreased significantly from 3.4 to 1.9 times more than among the population references. The effect was seen on sick leave, whereas disability pension levels remained similar in both groups throughout.

Conclusion.: Anti-TNF therapy in nr-axSpA was associated with a significant and sustained improvement of work disability over 2 years. However, the proportion of work-loss days remained almost twice as high as in the general population at the end of follow-up.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 56
Tidsskriftsnummer 5
Sider (fra-til) 716-724
Antal sider 9
ISSN 1462-0324
DOI
Status Udgivet - 1 maj 2017

Published in 2016

A comparison of Ancient Greek and Roman Sports Diets with Modern Day Practices

Harrison, A. & Bartels, E. M. 2016 I : Sports Nutrition and Therapy. 1, 1, s. 104 1000104

Publikation: Forskning - peer reviewTidsskriftartikel

With the preparations for the Olympics 2016 in Rio came a series of demands to the sports world in terms of attaining optimal physical performance for the many disciplines represented at today’s Olympics. In the light of this, we have focused on the dietary and physiological requirements of a modern Olympic athlete and contrast these with those of ancient Greek and Roman athletes. Our particular emphasis has been on the source of nutrients, historical dietary trends, and the search for the optimal sports diet, that is to say a diet that will ensure the attainment of an athlete’s full potential. In reality, nothing has changed between the ancient and modern athletes. To be optimal, a sports diet should be nutritionally balanced, whilst accommodating the genetic and environmental requirements, the gender and age needs, the demands of the sports discipline, as well as addressing any cultural dietary restrictions.
Originalsprog Engelsk
Artikelnummer 1000104
Tidsskrift Sports Nutrition and Therapy
Vol/bind 1
Tidsskriftsnummer 1
Sider (fra-til) 104
ISSN 2473-6449
Status Udgivet - 2016

Study Design Secondary analysis of clinical trial data. Background Knee osteoarthritis (OA) management has changed significantly over recent decades toward nonpharmacological treatments, particularly exercise. However, the optimal exercise program remains to be established. Objective To describe the implementation of standardized rescue exercises for patients with pain exacerbations and to assess whether performing these benefit or further worsen symptoms in patients with exacerbated symptoms of knee OA. Methods The data from 2 randomized controlled studies of exercise in patients with knee OA were used. A supervised, standard exercise program that included standardized "rescue" exercises to be performed in the event of symptomatic exacerbation, defined as knee pain of greater than 5 on a 0-to-10 numeric pain-rating scale, was conducted for 12 weeks at 3 sessions per week. Pain ratings were obtained before and after each exercise session. Results Of 131 participants included, 2 never commenced the exercise program, leaving 129 to be included in the analysis. The analysis was observational and thus had no comparison group. During the program, 36 participants (28%) were referred to the rescue exercises. In 63% of the rescue sessions, the participants experienced decreased pain intensity (average ± SD, -2.6 ± 2.3), 27% reported no change in pain, and 10% reported increased pain intensity (average ± SD, 1.3 ± 0.5). Conclusion Having a predefined and standardized rescue exercise option appears beneficial, and did not result in further worsening of exacerbated knee OA symptoms. The intervention may be particularly relevant for patients with knee OA who have more severe symptoms. Level of Evidence Therapy, level 2b. Registered at www.clinicaltrials.gov (NCT01545258 and NCT01945749). J Orthop Sports Phys Ther 2016;46(11):942-946. Epub 28 Sep 2016. doi:10.2519/jospt.2016.6908.

Originalsprog Engelsk
Tidsskrift The Journal of orthopaedic and sports physical therapy
Vol/bind 46
Tidsskriftsnummer 11
Sider (fra-til) 942-946
Antal sider 5
ISSN 0190-6011
DOI
Status Udgivet - nov. 2016

Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis: A Meta-Research Project

Amarilyo, G., Furst, D. E., Woo, J. M. P., Li, W., Bliddal, H., Christensen, R. & Tarp, S. 2016 I : P L o S One. 11, 1, s. e0147556

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website.

OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.

METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.

RESULTS: FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34) except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61) pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55) pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.

CONCLUSION: There was no empirical evidence to suggest biased estimates between the two sources. Increased and detailed transparency in publications would improve the understanding and credibility of published results. Further, the FDA report was found to be a useful source when data are missing in the published report (i.e. reporting bias).

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 11
Tidsskriftsnummer 1
Sider (fra-til) e0147556
ISSN 1932-6203
DOI
Status Udgivet - 2016

OBJECTIVES: With the present study we wanted to explore the impact of treatment with a tumor necrosis factor-α -inhibitor (TNFi) on levels of soluble biomarkers in rheumatoid arthritis (RA) patients and to identify predictors of impaired drug levels and development of anti-TNFi antibodies (anti-TNFi Abs).

METHODS: Blood samples from 26 patients with established RA were taken at baseline and following 6 months of treatment with adalimumab or infliximab. Samples were analyzed for levels of TNFi, interleukin (IL)-6, and soluble TNF-receptors 1 and -2 (sTNF-R1 and -2) and for presence of anti-TNFi Abs. Clinical and demographic data were recorded as well.

RESULTS: During the initial 6 months treatment, DAS28(CRP) (Disease activity score in 28 joints using C-reactive protein) and levels of IL-6 and sTNF-R2 decreased significantly in patients without anti-TNFi Abs and in patients retaining detectable drug levels. The levels of other tested cytokines (TNF-α, TNF-β, IL-1ra, IL-1b, IL-8, IL-10, IL-12(p70), IL-13, IL-17A, IL-17F, and IL-33) were generally below detection limits. Higher baseline levels of IL-6 associated with undetectable levels of TNFi at follow-up. Anti-TNFi Abs were associated with decreased drug levels, but no predictors for anti-TNFi Ab development could be found.

CONCLUSION: The effect of treatment with TNFi on RA disease activity depends on levels of active drug, and by presence of anti-TNFi Abs. In patients who retain detectable drug levels, and in the absence of anti-TNFi Abs, clinical outcome is improved during treatment, and circulating levels of IL-6 and sTNF-R2 decrease. Baseline levels of IL-6 may predict depletion of TNFi and may identify patients at risk of treatment failure.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 11
Tidsskriftsnummer 9
Sider (fra-til) e0162316
ISSN 1932-6203
DOI
Status Udgivet - 2016

Aquatic exercise for the treatment of knee and hip osteoarthritis

Bartels, E. M., Juhl, C. B., Christensen, R., Hagen, K. B., Danneskiold-Samsøe, B., Dagfinrud, H. & Lund, H. 2016 I : Cochrane Database of Systematic Reviews. 3, s. CD005523

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Osteoarthritis is a chronic disease characterized by joint pain, tenderness, and limitation of movement. At present, no cure is available. Thus only treatment of the person's symptoms and treatment to prevent further development of the disease are possible. Clinical trials indicate that aquatic exercise may have advantages for people with osteoarthritis. This is an update of a published Cochrane review.

OBJECTIVES: To evaluate the effects of aquatic exercise for people with knee or hip osteoarthritis, or both, compared to no intervention.

SEARCH METHODS: We searched the following databases up to 28 April 2015: the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library Issue 1, 2014), MEDLINE (from 1949), EMBASE (from 1980), CINAHL (from 1982), PEDro (Physiotherapy Evidence Database), and Web of Science (from 1945). There was no language restriction.

SELECTION CRITERIA: Randomized controlled clinical trials of aquatic exercise compared to a control group (e.g. usual care, education, social attention, telephone call, waiting list for surgery) of participants with knee or hip osteoarthritis.

DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data and assessed risk of bias of the included trials. We analysed the pooled results using standardized mean difference (SMD) values.

MAIN RESULTS: Nine new trials met the inclusion criteria and we excluded two earlier included trials. Thus the number of participants increased from 800 to 1190 and the number of included trials increased from six to 13. Most participants were female (75%), with an average age of 68 years and a body mass index (BMI) of 29.4. Osteoarthritis duration was 6.7 years, with a great variation of the included participants. The mean aquatic exercise duration was 12 weeks. We found 12 trials at low to unclear risk of bias for all domains except blinding of participants and personnel. They showed that aquatic exercise caused a small short term improvement compared to control in pain (SMD -0.31, 95% CI -0.47 to -0.15; 12 trials, 1076 participants) and disability (SMD -0.32, 95% CI -0.47 to -0.17; 12 trials, 1059 participants). Ten trials showed a small effect on quality of life (QoL) (SMD -0.25, 95% CI -0.49 to -0.01; 10 trials, 971 participants). These effects on pain and disability correspond to a five point lower (95% CI three to eight points lower) score on mean pain and mean disability compared to the control group (scale 0 to 100), and a seven point higher (95% CI 0 to 13 points higher) score on mean QoL compared with control group (scale 0 to 100). No included trials performed a radiographic evaluation. No serious adverse events were reported in the included trials with relation to aquatic exercise.

AUTHORS' CONCLUSIONS: There is moderate quality evidence that aquatic exercise may have small, short-term, and clinically relevant effects on patient-reported pain, disability, and QoL in people with knee and hip OA. The conclusions of this review update does not change those of the previous published version of this Cochrane review.

Originalsprog Engelsk
Tidsskrift Cochrane Database of Systematic Reviews
Vol/bind 3
Sider (fra-til) CD005523
ISSN 1469-493X
DOI
Status Udgivet - 2016
Originalsprog Engelsk
Tidsskrift Disability and Rehabilitation
ISSN 0963-8288
Status Udgivet - jun. 2016
Originalsprog Dansk
Udgivelses sted København
Vol/bind 1
Udgave 1
Status Udgivet - 18 aug. 2016

BACKGROUND: Previous studies have suggested a direct association between hair cortisol concentration (HCC) and Body Mass Index (BMI), as well as other adiposity measures. However, these studies have mostly been conducted among adult populations.

OBJECTIVE: To examine the association between HCC and different measures of adiposity among a selected group of children predisposed to obesity and their parents.

METHODS: We conducted a cross-sectional study based on 363 children and their parents (301 mothers and 231 fathers) participating in the "Healthy Start" study. Linear regression analysis was used to investigate associations between HCC and adiposity measures while taking into account possible confounding factors. Analyses were performed examining the association between HCC and BMI, fat mass and fat free mass index Z-scores, as well as waist circumference and waist-hip ratio among the children. Likewise, the association between HCC and BMI among the parents was explored. Finally, we examined the association between parental HCC and children's adiposity measures.

RESULTS: HCC was directly associated with a higher BMI among the fathers (0.49 kg/m2 [95% CI: 0.09, 0.90, P = 0.02] per 100 pg/mg) and the mothers (0.93 kg/m2 [95% CI: 0.24, 1.61, P = 0.01] per 100 pg/mg). We found no clear evidence of an association between HCC and adiposity measures among children. However, a high maternal HCC was associated with a high fat mass index and low fat free mass index z-score in the offspring (0.14 SD [95% CI: 0.02, 0.26, P = 0.02] and -0.17 SD [95% CI: -0.30, -0.05, P = 0.01] per 100 pg/mg, respectively).

CONCLUSIONS: Our study found no evidence of an association between HCC and measures of adiposity among children predisposed to obesity. However, HCC may be directly associated with BMI among men and women, and maternal HCC may be related to a higher fat mass and a lower fat free mass among their children.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 11
Tidsskriftsnummer 9
Sider (fra-til) e0163639
ISSN 1932-6203
DOI
Status Udgivet - 24 sep. 2016

Association between Maternal Fish Consumption and Gestational Weight Gain: Influence of Molecular Genetic Predisposition to Obesity

Larsen, S. C., Ängquist, L., Laurin, C., Schmidt Morgen, C., Jakobsen, M. U., Paternoster, L., Smith, G. D., Olsen, S. F., Sørensen, T. I. A. & Nohr, E. A. 2016 I : P L o S One. 11, 3, s. e0150105

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Studies suggest that fish consumption can restrict weight gain. However, little is known about how fish consumption affects gestational weight gain (GWG), and whether this relationship depends on genetic makeup.

OBJECTIVE: To examine the association between fish consumption and GWG, and whether this relationship is dependent on molecular genetic predisposition to obesity.

DESIGN: A nested case-cohort study based on the Danish National Birth Cohort (DNBC) sampling the most obese women (n = 990) and a random sample of the remaining participants (n = 1,128). Replication of statistically significant findings was attempted in the Avon Longitudinal Study of Parents and Children (ALSPAC) (n = 4,841). We included 32 body mass index (BMI) associated single nucleotide polymorphisms (SNPs) and 5 SNPs found associated with GWG. BMI associated SNPs were combined in a genetic risk score (GRS). Associations between consumption of fish, GRS or individual variants and GWG were analysed, and interactions between fish and the GRS or individual variants were examined.

RESULTS: In the DNBC, each portion/week (150 g) of fatty fish was associated with a higher GWG of 0.58 kg (95% CI: 0.16, 0.99, P<0.01). For total fish and lean fish, similar patterns were observed, but these associations were not statistically significant. We found no association between GRS and GWG, and no interactions between GRS and dietary fish on GWG. However, we found an interaction between the PPARG Pro12Ala variant and dietary fish. Each additional Pro12Ala G-allele was associated with a GWG of -0.83 kg (95% CI: -1.29, -0.37, P<0.01) per portion/week of dietary fish, with the same pattern for both lean and fatty fish. In ALSPAC, we were unable to replicate these findings.

CONCLUSION: We found no consistent evidence of association between fish consumption and GWG, and our results indicate that the association between dietary fish and GWG has little or no dependency on GRS or individual SNPs.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 11
Tidsskriftsnummer 3
Sider (fra-til) e0150105
ISSN 1932-6203
DOI
Status Udgivet - 2016

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