Published in 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
Vol/bind 76
Tidsskriftsnummer 11
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: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

Assesing synovitis with conventional static and dynamic contrast-enhanced magnetic sesonance imaging in knee osteoarthritis

Riis, R. G. C. 18 aug. 2016 1 udg. København.

Publikation: Bog/antologi/afhandling/rapportPh.d.-afhandlingForskning

Originalsprog Dansk
Udgivelses sted København
Vol/bind 1
Udgave 1
Status Udgivet - 18 aug. 2016

Association between Hair Cortisol Concentration and Adiposity Measures among Children and Parents from the "Healthy Start" Study

Larsen, S. C., Fahrenkrug, J., Olsen, N. J. & Heitmann, B. L. 24 sep. 2016 I : P L o S One. 11, 9, s. e0163639

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

Association of Physical Fitness with Depression in Women with Fibromyalgia

Soriano-Maldonado, A., Estévez-López, F., Segura-Jiménez, V., Aparicio, V. A., Álvarez-Gallardo, I. C., Herrador-Colmenero, M., Ruiz, J. R., Henriksen, M., Amris, K., Delgado-Fernández, M. & al-Ándalus Project 2016 I : Pain medicine (Malden, Mass.). 17, 8, s. 1542-1552

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: . The aim of this study was to examine the association between physical fitness and depressive symptoms in women with fibromyalgia (FM). We also assessed whether different fitness components present independent relationships with depressive symptoms.

DESIGN: . Cross-sectional study.

SETTING: . University facilities and FM associations.

SUBJECTS: . Four hundred and forty-four patients with FM according to the 1990 American College of Rheumatology criteria.

METHODS: . Depressive symptoms were assessed using the Beck Depression Inventory (BDI-II). Physical fitness (aerobic fitness, muscle strength, flexibility, and motor agility) was assessed using the standardized Senior Fitness Test battery and the handgrip strength test. A standardized composite score for fitness was computed and divided into quintiles.

RESULTS: . Overall, the fitness tests presented inverse associations with the total BDI-II score (P < 0.05). The patients in the highest fitness quintile had 8.4% lower depressive symptoms than the patients in the lowest fitness quintile (P = 0.014). The odds of severe symptoms of depression were between 3.7% and 16.9% lower for each performance unit in the back-scratch, handgrip, arm-curl, and eight-feet up-and-go tests. When all the fitness tests were simultaneously considered, the back-scratch test was the only one independently associated with the total BDI-II score (P = 0.001; R(2) = 0.023).

CONCLUSIONS: . Although higher physical fitness was generally associated with lower symptoms of depression in women with FM, the observed associations were somewhat weak and inconsistent, differing from those previously observed in healthy adults. Further research to determine the clinical relevance of the association between physical fitness and depression in FM is warranted.

Originalsprog Engelsk
Tidsskrift Pain medicine (Malden, Mass.)
Vol/bind 17
Tidsskriftsnummer 8
Sider (fra-til) 1542-1552
ISSN 1526-2375
DOI
Status Udgivet - 2016

Associations Between Swedish Mothers' and 3- and 5-Year-Old Children's Food Intake

Hansson, L. M., Heitmann, B. L., Larsson, C., Tynelius, P., Willmer, M. & Rasmussen, F. sep. 2016 I : Journal of Nutrition Education and Behavior. 48, 8, s. 520-529.e1

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To investigate associations between mothers' and children's food intake.

DESIGN: Cross-sectional study. Background variables collected through self-reports and from the register of the total population. Mothers recorded their own and their children's food intake in a diary during 2 4-day periods.

SETTING: Eight counties in mid Sweden.

PARTICIPANTS: Three- and 5-year-old children and their mothers were randomly selected from the register of the total population. A total of 2,045 families were invited, 355 of whom accepted. Mothers who accepted were older and to a larger extent born in Sweden. The final sample of mother-child pairs with complete food records was 189.

MAIN OUTCOME MEASURES: Mothers' and children's food intake (16 food items).

ANALYSIS: Spearman rank-order correlation with 95% confidence intervals (2-sided). Moderation was investigated using generalized estimation equations with robust variance.

RESULTS: The strongest correlations between mothers' and children's food intake were found for pizza and oily fish (r = .70-.80). The weakest correlations were found for sugared drinks and fruit and berries (r = .24-.26). Children's age moderated the relationship between mothers' and children's intake of savoury snacks, as did place of residence for pizza intake.

CONCLUSIONS AND IMPLICATIONS: There were substantial correlations between children's and mothers' intake of various foods. Modeling of mothers' intake might be more effective in influencing young children's intake of certain foods, whereas other strategies, such as encouraging parents to influence food availability (eg, gatekeeping), might be more useful for some foods.

Originalsprog Engelsk
Tidsskrift Journal of Nutrition Education and Behavior
Vol/bind 48
Tidsskriftsnummer 8
Sider (fra-til) 520-529.e1
ISSN 1499-4046
DOI
Status Udgivet - sep. 2016

Biologic interventions for fatigue in rheumatoid arthritis

Almeida, C., Choy, E. H. S., Hewlett, S., Kirwan, J. R., Cramp, F., Chalder, T., Pollock, J. & Christensen, R. 2016 I : Cochrane Database of Systematic Reviews. 6, s. CD008334

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Fatigue is a common and potentially distressing symptom for patients with rheumatoid arthritis (RA), with no accepted evidence-based management guidelines. Evidence suggests that biologic interventions improve symptoms and signs in RA as well as reducing joint damage.

OBJECTIVES: To evaluate the effect of biologic interventions on fatigue in rheumatoid arthritis.

SEARCH METHODS: We searched the following electronic databases up to 1 April 2014: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Current Controlled Trials Register, the National Research Register Archive, The UKCRN Portfolio Database, AMED, CINAHL, PsycINFO, Social Science Citation Index, Web of Science, and Dissertation Abstracts International. In addition, we checked the reference lists of articles identified for inclusion for additional studies and contacted key authors.

SELECTION CRITERIA: We included randomised controlled trials if they evaluated a biologic intervention in people with rheumatoid arthritis and had self reported fatigue as an outcome measure.

DATA COLLECTION AND ANALYSIS: Two reviewers selected relevant trials, assessed methodological quality and extracted data. Where appropriate, we pooled data in meta-analyses using a random-effects model.

MAIN RESULTS: We identified 32 studies for inclusion in this current review. Twenty studies evaluated five anti-tumour necrosis factor (anti-TNF) biologic agents (adalimumab, certolizumab, etanercept, golimumab and infliximab), and 12 studies focused on five non-anti-TNF biologic agents (abatacept, canakinumab, rituximab, tocilizumab and an anti-interferon gamma monoclonal antibody). All but two of the studies were double-blind randomised placebo-controlled trials. In some trials, patients could receive concomitant disease-modifying anti-rheumatic drugs (DMARDs). These studies added either biologics or placebo to DMARDs. Investigators did not change the dose of the latter from baseline. In total, these studies included 9946 participants in the intervention groups and 4682 participants in the control groups. Overall, quality of randomised controlled trials was moderate with a low to unclear risk of bias in the reporting of the outcome of fatigue. We downgraded the quality of the studies from high to moderate because of potential reporting bias (studies included post hoc analyses favouring reporting of positive result and did not always include all randomised individuals). Some studies recruited only participants with early disease. The studies used five different instruments to assess fatigue in these studies: the Functional Assessment of Chronic Illness Therapy Fatigue Domain (FACIT-F), Short Form-36 Vitality Domain (SF-36 VT), Visual Analogue Scale (VAS) (0 to 100 or 0 to 10) and the Numerical Rating Scale (NRS). We calculated standard mean differences for pooled data in meta-analyses. Overall treatment by biologic agents led to statistically significant reduction in fatigue with a standardised mean difference of -0.43 (95% confidence interval (CI) -0.38 to -0.49). This equates to a difference of 6.45 units (95% CI 5.7 to 7.35) of FACIT-F score (range 0 to 52). Both types of biologic agents achieved a similar level of improvement: for anti-TNF agents, this stood at -0.42 (95% CI -0.35 to -0.49), equivalent to 6.3 units (95% CI 5.3 to 7.4) on the FACIT-F score; and for non-anti-TNF agents, it was -0.46 (95% CI -0.39 to -0.53), equivalent to 6.9 units (95% CI 5.85 to 7.95) on the FACIT-F score. In most studies, the double-blind period was 24 weeks or less. No study assessed long-term changes in fatigue.

AUTHORS' CONCLUSIONS: Treatment with biologic interventions in patients with active RA can lead to a small to moderate improvement in fatigue. The magnitude of improvement is similar for anti-TNF and non-anti-TNF biologics. However, it is unclear whether the improvement results from a direct action of the biologics on fatigue or indirectly through reduction in inflammation, disease activity or some other mechanism.

Originalsprog Engelsk
Tidsskrift Cochrane Database of Systematic Reviews
Tidsskriftsnummer 6
Sider (fra-til) CD008334
ISSN 1469-493X
DOI
Status Udgivet - 2016

Biological agents in polyarticular juvenile idiopathic arthritis: A meta-analysis of randomized withdrawal trials

Amarilyo, G., Tarp, S., Foeldvari, I., Cohen, N., Pope, T. D., Woo, J. M. P., Christensen, R. & Furst, D. E. dec. 2016 I : Seminars in Arthritis and Rheumatism. 46, 3, s. 312-318 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND AND OBJECTIVE: Although various biological agents are in use for polyarticular juvenile idiopathic arthritis (pJIA), head-to-head trials comparing the efficacy and safety among them are lacking. We aimed to compare the efficacy and safety of biological agents in pJIA using all currently available randomized withdrawal trials (wRCTs).

METHODS: A systematic search of MEDLINE, EMBASE, CENTRAL, and clinicaltrials.gov was performed. Eligible wRCTs: patients with pJIA where a biological agent was compared with another biological agent or placebo. Efficacy was evaluated using disease flare as a measure. Adverse events (AEs) and serious AEs were evaluated. Network meta-analysis compared biological agents based on a (empirical Bayes) mixed-effects logistic regression model that combines statistical inference from both direct and indirect comparisons of the treatment effects between biological agents.

RESULTS: Of 496 references identified, five wRCTs were included-abatacept, adalimumab, anakinra, etanercept, and tocilizumab, one trial each, all vs. placebo. There were no differences in efficacy among biological agents and most showed statistically significant efficacy compared with placebo (nearly all exceptions were in agreement with the original study data). Serious AEs occurred very infrequently (0-8%) and an analysis was not possible. There were no differences for AEs when compared among biological agents or to placebo.

CONCLUSION: There were no statistical differences among biological agents for efficacy or safety. Overall, biological agents were effective and safe when compared to placebo. Based on these data, other considerations such as price and availability may need to be used to decide among biological agents when treating pJIA patients.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 46
Tidsskriftsnummer 3
Sider (fra-til) 312-318
Antal sider 7
ISSN 0049-0172
DOI
Status Udgivet - dec. 2016

Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease-modifying anti-rheumatic drugs: a systematic review and network meta-analysis

Singh, J. A., Hossain, A., Tanjong Ghogomu, E., Kotb, A., Christensen, R., Mudano, A. S., Maxwell, L. J., Shah, N. P., Tugwell, P. & Wells, G. A. 2016 I : Cochrane Database of Systematic Reviews. 5, s. CD012183

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: This is an update of the 2009 Cochrane overview and network meta-analysis (NMA) of biologics for rheumatoid arthritis (RA).

OBJECTIVES: To assess the benefits and harms of nine biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib, versus comparator (MTX, DMARD, placebo (PL), or a combination) in adults with rheumatoid arthritis who have failed to respond to methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs), i.e., MTX/DMARD incomplete responders (MTX/DMARD-IR).

METHODS: We searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (via The Cochrane Library Issue 6, June 2015), MEDLINE (via OVID 1946 to June 2015), and EMBASE (via OVID 1947 to June 2015). Data extraction, risk of bias and GRADE assessments were done in duplicate. We calculated both direct estimates using standard meta-analysis and used Bayesian mixed treatment comparisons approach for NMA estimates to calculate odds ratios (OR) and 95% credible intervals (CrI). We converted OR to risk ratios (RR) which are reported in the abstract for the ease of interpretation.

MAIN RESULTS: This update included 73 new RCTs for a total of 90 RCTs; 79 RCTs with 32,874 participants provided usable data. Few trials were at high risk of bias for blinding of assessors/participants (13% to 21%), selective reporting (4%) or major baseline imbalance (8%); a large number had unclear risk of bias for random sequence generation (68%) or allocation concealment (74%).Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a statistically significant and clinically meaningful improvement in ACR50 versus comparator (RR 2.71 (95% confidence interval (CI) 2.36 to 3.10); absolute benefit 24% more patients (95% CI 19% to 29%), number needed to treat for an additional beneficial outcome (NNTB) = 5 (4 to 6). NMA estimates for ACR50 in tumor necrosis factor (TNF) biologic+MTX/DMARD (RR 3.23 (95% credible interval (Crl) 2.75 to 3.79), non-TNF biologic+MTX/DMARD (RR 2.99; 95% Crl 2.36 to 3.74), and anakinra + MTX/DMARD (RR 2.37 (95% Crl 1.00 to 4.70) were similar to the direct estimates.Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a clinically and statistically important improvement in function measured by the Health Assessment Questionnaire (0 to 3 scale, higher = worse function) with a mean difference (MD) based on direct evidence of -0.25 (95% CI -0.28 to -0.22); absolute benefit of -8.3% (95% CI -9.3% to -7.3%), NNTB = 3 (95% CI 2 to 4). NMA estimates for TNF biologic+MTX/DMARD (absolute benefit, -10.3% (95% Crl -14% to -6.7%) and non-TNF biologic+MTX/DMARD (absolute benefit, -7.3% (95% Crl -13.6% to -0.67%) were similar to respective direct estimates.Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with clinically and statistically significantly greater proportion of participants achieving remission in RA (defined by disease activity score DAS < 1.6 or DAS28 < 2.6) versus comparator (RR 2.81 (95% CI, 2.23 to 3.53); absolute benefit 18% more patients (95% CI 12% to 25%), NNTB = 6 (4 to 9)). NMA estimates for TNF biologic+MTX/DMARD (absolute improvement 17% (95% Crl 11% to 23%)) and non-TNF biologic+MTX/DMARD (absolute improvement 19% (95% Crl 12% to 28%) were similar to respective direct estimates.Based on direct evidence of moderate quality (downgraded for inconsistency), radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologics + MTX/DMARDs versus comparator, MD -2.61 (95% CI -4.08 to -1.14). The absolute reduction was small, -0.58% (95% CI -0.91% to -0.25%) and we are unsure of the clinical relevance of this reduction. NMA estimates of TNF biologic+MTX/DMARD (absolute reduction -0.67% (95% Crl -1.4% to -0.12%) and non-TNF biologic+MTX/DMARD (absolute reduction, -0.68% (95% Crl -2.36% to 0.92%)) were similar to respective direct estimates.Based on direct evidence of moderate quality (downgraded for imprecision), results for withdrawals due to adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase in withdrawals, RR 1.11 (95% CI 0.96 to 1.30). The NMA estimates of TNF biologic+MTX/DMARD (RR 1.24 (95% Crl 0.99 to 1.57)) and non-TNF biologic+MTX/DMARD (RR 1.20 (95% Crl 0.87 to 1.67)) were similarly inconclusive and downgraded to low for both imprecision and indirectness.Based on direct evidence of high quality, biologic+MTX/DMARD was associated with clinically significantly increased risk (statistically borderline significant) of serious adverse events on biologic+MTX/DMARD (Peto OR [can be interpreted as RR due to low event rate] 1.12 (95% CI 0.99 to 1.27); absolute risk 1% (0% to 2%), As well, the NMA estimate for TNF biologic+MTX/DMARD (Peto OR 1.20 (95% Crl 1.01 to 1.43)) showed moderate quality evidence of an increase in the risk of serious adverse events. The other two NMA estimates were downgraded to low quality due to imprecision and indirectness and had wide confidence intervals resulting in uncertainty around the estimates: non-TNF biologics + MTX/DMARD: 1.07 (95% Crl 0.89 to 1.29) and anakinra: RR 1.06 (95% Crl 0.65 to 1.75).Based on direct evidence of low quality (downgraded for serious imprecision), results were inconclusive for cancer (Peto OR 1.07 (95% CI 0.68 to 1.68) for all biologic+MTX/DMARD combinations. The NMA estimates of TNF biologic+MTX/DMARD (Peto OR 1.21 (95% Crl 0.63 to 2.38) and non-TNF biologic+MTX/DMARD (Peto OR 0.99 (95% Crl 0.58 to 1.78)) were similarly inconclusive and downgraded to low quality for both imprecision and indirectness.Main results text shows the results for tofacitinib and differences between medications.

AUTHORS' CONCLUSIONS: Based primarily on RCTs of 6 months' to 12 months' duration, there is moderate quality evidence that the use of biologic+MTX/DMARD in people with rheumatoid arthritis who have failed to respond to MTX or other DMARDs results in clinically important improvement in function and higher ACR50 and remission rates, and increased risk of serious adverse events than the comparator (MTX/DMARD/PL; high quality evidence). Radiographic progression is slowed but its clinical relevance is uncertain. Results were inconclusive for whether biologics + MTX/DMARDs are associated with an increased risk of cancer or withdrawals due to adverse events.

Originalsprog Engelsk
Tidsskrift Cochrane Database of Systematic Reviews
Tidsskriftsnummer 5
Sider (fra-til) CD012183
ISSN 1469-493X
DOI
Status Udgivet - 2016

Calcium, vitamin D, casein and whey protein intakes and periodontitis among Danish adults

Adegboye, A. R., Boucher, B. J., Kongstad, J., Fiehn, N-E., Christensen, L. B. & Heitmann, B. L. feb. 2016 I : Public Health Nutrition. 19, 3, s. 503-10 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To investigate whether intakes of Ca, vitamin D, casein and whey are associated with periodontitis and to investigate the possibility of interactions between them.

DESIGN: Cross-sectional study. An Internet-based, 267-item FFQ was used to assess dietary intake. Intakes of casein (32·0 g/d), whey proteins (9·6 g/d) and vitamin D (5·8 μg/d) were classified as within v. above the 50th percentile. Ca intake was classified as within v. below age-specific recommendations. Severe periodontitis was defined as having ≥2 inter-proximal sites with clinical attachment loss ≥6 mm (not on the same tooth) and ≥1 inter-proximal site with pocket depth ≥5 mm. Since vitamin D influences Ca absorption, models were stratified by lower and higher (<5·8 v. ≥5·8 µg/d) vitamin D intake.

SETTING: Danish Health Examination Survey (DANHES) 2007-2008.

SUBJECTS: Adult participants (n 3287) in the oral health study of DANHES 2007-2008.

RESULTS: Intakes of Ca within recommendations (OR=0·76; 95 % CI 0·58, 0·99), whey ≥9·6 g/d (OR=0·75; 95 % CI 0·58, 0·97) and casein ≥32 g/d (OR=0·75 95 % CI 0·58, 0·97) were associated with lower likelihood of severe periodontitis after adjustment for age, gender, education, smoking, sucrose intake, alcohol consumption, number of teeth, daily brushing, regular visits to the dentist and chronic illness, irrespective of vitamin D intake levels. Intake of vitamin D alone was not associated severe with periodontitis.

CONCLUSIONS: Intakes of Ca, casein and whey protein were inversely associated with periodontitis. Consumption of foods rich in Ca, casein and whey (e.g. dairy foods) should be promoted, as they may contribute to the prevention of periodontitis. Further longitudinal studies are required to confirm these associations.

Originalsprog Engelsk
Tidsskrift Public Health Nutrition
Vol/bind 19
Tidsskriftsnummer 3
Sider (fra-til) 503-10
Antal sider 8
ISSN 1368-9800
DOI
Status Udgivet - feb. 2016

Can positional MRI predict dynamic changes in the medial plantar arch? An exploratory pilot study

Johannsen, F., Hansen, P., Stallknecht, S., Rathleff, M. S., Hangaard, S., Nybing, J. D. & Boesen, M. 2016 I : Journal of Foot & Ankle Surgery. 9, s. 35

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Positional MRI (pMRI) allows for three-dimensional visual assessment of navicular position. In this exploratory pilot study pMRI was validated against a stretch sensor device, which measures movement of the medial plantar arch. We hypothesized that a combined pMRI measure incorporating both vertical and medial displacement of the navicular bone induced by loading would be correlated with corresponding stretch sensor measurements.

METHODS: 10 voluntary participants were included in the study. Both pMRI and subsequent stretch sensor measurements were performed in a) supine, b) standing and c) standing position with addition of 10 % body weight during static loading of the foot. Stretch sensor measurements were also performed during barefoot walking.

RESULTS: The total change in navicular position measured by pMRI was 10.3 mm (CI: 7.0 to 13.5 mm). No further displacement occurred when adding 10 % bodyweight (mean difference: 0.7 mm (CI: -0.7 to 2.0 mm), P = 0.29). The total navicular displacement correlated with stretch sensor measurement under static loading conditions (Spearman's rho = 0.66, P = 0.04) but not with measurements during walking (Spearman's rho = 0.58, P = 0.08).

CONCLUSIONS: Total navicular bone displacements determined by pMRI showed concurrent validity with stretch sensor measurements but only so under static loading conditions. Although assessment of total navicular displacement by combining concomitant vertical and medial navicular bone movements would appear advantageous compared to monoplanar measurement the combined measure did not seem to predict dynamic changes of the medial foot arch during walking, which are among several possible factors depending on different walking patterns.

Originalsprog Engelsk
Tidsskrift Journal of Foot & Ankle Surgery
Vol/bind 9
Sider (fra-til) 35
ISSN 1067-2516
DOI
Status Udgivet - 2016

OBJECTIVE: Knee osteoarthritis (KOA) is a multifactorial joint disease affecting many people worldwide. Recommended treatments for KOA include exercise and steroid injections, or a combination of these. The objective of this exploratory outcome analysis of a randomized trial was to assess changes in inflammation markers assessed by ultrasound imaging (US) in KOA secondary to intra-articular corticosteroid injection given prior to exercise therapy.

DESIGN: This study is a sub-study to a larger clinical trial which compared the clinical effects of steroid injection in KOA to placebo injection, both given prior to exercise therapy. The US outcomes were changes from baseline in US-assessed synovial size, Doppler activity presence in the synovial membrane, and numbers of US-detected Baker's cysts. US was performed at baseline, week 14 (exercise stop), and week 26 (follow-up).

RESULTS: Fifty participants received steroid injection, and 50 received placebo injection. All participants received 12 weeks of exercise. Forty-five and 44, respectively, completed the study. At week 14, the group difference in the change in synovium thickness was 2.2 mm (95%, confidence interval (CI) -0.5 to 4.8), P = 0.11. There were no group differences in the changes in distribution of patients with presence of synovial Doppler activity (P = 0.98) or Baker's cysts (P = 0.35). There were no statistically significant differences between groups at week 26 in any outcome.

CONCLUSION: Intra-articular steroid injection of KOA-patients prior to a 3 months exercise programme did not reduce synovial hypertrophy, synovial Doppler activity, or Baker's cyst presence more than a placebo saline injection according to US-assessments.

TRIAL REGISTRATION: EudraCT: 2012-002607-18.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Vol/bind 24
Tidsskriftsnummer 5
Sider (fra-til) 814-21
Antal sider 8
ISSN 1063-4584
DOI
Status Udgivet - maj 2016

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