Published in 2016

BACKGROUND: Subgroups of women with fibromyalgia likely show different activity of daily living (ADL) skill deficits. Identifying ineffective ADL skills of significance in the 'typical' woman with fibromyalgia will promote the planning of targeted occupational therapy interventions aiming at improving ADL ability.

OBJECTIVE: To identify frequently reported ADL skill deficits of significance in subgroups of women with fibromyalgia who have decreased ADL motor ability in combination with decreased or competent ADL process ability.

METHOD: Women with fibromyalgia were evaluated with the Assessment of Motor and Process Skills (AMPS). If they demonstrated decreased ADL motor ability, the calibrated AMPS raters identified and reported ineffective ADL skills of significance. Descriptive comparisons were made between subgroups displaying either decreased or competent ADL process ability.

RESULTS: Moves, calibrates, bends, reaches, and paces were identified as the most frequently reported ineffective ADL skills of significance within the total sample (n = 188). The ADL process skills items organise and accommodate were identified as ineffective only in the subgroup with decreased ADL process ability (n = 105).

CONCLUSION: It is suggested that clinicians modify the individual's tasks and environments to compensate for identified ineffective ADL skills and to use the AMPS to differentiate interventions in women with fibromyalgia.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
Vol/bind 23
Tidsskriftsnummer 5
Sider (fra-til) 391-7
Antal sider 7
ISSN 1103-8128
DOI
Status Udgivet - sep. 2016

OBJECTIVE: Studies have suggested that total intake of trans-fatty acids (TFA) is positively associated with changes in body weight and waist circumference, whereas intake of TFA from ruminant dairy and meat products (R-TFA) has not been associated with weight gain. However, these previous studies are limited by self-reported measures of body weight and waist circumference or by a cross-sectional design. The objective of the present study was to investigate if R-TFA intake was associated with subsequent changes in anthropometry (body weight, waist and hip circumference) measured by technicians and body composition (body fat percentage).

DESIGN: A 6-year follow-up study. Information on dietary intake was collected through diet history interviews, and anthropometric and bioelectrical impedance measurements were obtained by trained technicians at baseline (1987-1988) and at follow-up (1993-1994). Multiple regression with cubic spline modelling was used to analyse the data.

SETTING: Copenhagen County, Denmark.

SUBJECTS: Two hundred and sixty-seven men and women aged 35-65 years from the Danish MONICA (MONItoring of trends and determinants in CArdiovascular diseases) cohort.

RESULTS: The median R-TFA intake was 1·3 g/d (5th, 95th percentile: 0·4, 2·7 g/d) or 0·6 % of the total energy intake (5th, 95th percentile: 0·2, 1·1 %). No significant associations were observed between R-TFA intake and changes in body weight, waist and hip circumference or body fat percentage.

CONCLUSIONS: R-TFA intake within the range present in the Danish population was not significantly associated with subsequent changes in body size, shape or composition and the 95 % confidence intervals indicate that any relevant associations are unlikely to have produced these observations.

Originalsprog Engelsk
Tidsskrift Public Health Nutrition
Vol/bind 19
Tidsskriftsnummer 3
Sider (fra-til) 494-502
Antal sider 9
ISSN 1368-9800
DOI
Status Udgivet - 2016

Intake of Total and Subgroups of Fat Minimally Affect the Associations between Selected Single Nucleotide Polymorphisms in the PPARγ Pathway and Changes in Anthropometry among European Adults from Cohorts of the DiOGenes Study

Larsen, S. C., Ängquist, L., Østergaard, J. N., Ahluwalia, T. S., Vimaleswaran, K. S., Roswall, N., Mortensen, L. M., Nielsen, B. M., Tjønneland, A., Wareham, N. J., Palli, D., Masala, G., Saris, W. H., van der A, D. L., Boer, J. M., Feskens, E. J., Boeing, H., Jakobsen, M. U., Loos, R. J., Sørensen, T. I. & Overvad, K. mar. 2016 I : The Journal of Nutrition. 146, 3, s. 603-11 9 s.

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Although the peroxisome proliferator-activated receptor γ (PPARγ) pathway is central in adipogenesis, it remains unknown whether it influences change in body weight (BW) and whether dietary fat has a modifying effect on the association.

OBJECTIVES: We examined whether 27 single nucleotide polymorphisms (SNPs) within 4 genes in the PPARγ pathway are associated with the OR of being a BW gainer or with annual changes in anthropometry and whether intake of total fat, monounsaturated fat, polyunsaturated fat, or saturated fat has a modifying effect on these associations.

METHODS: A case-noncase study included 11,048 men and women from cohorts in the European Diet, Obesity and Genes study; 5552 were cases, defined as individuals with the greatest BW gain during follow-up, and 6548 were randomly selected, including 5496 noncases. We selected 4 genes [CCAAT/enhancer binding protein β (CEBPB), phosphoenolpyruvate carboxykinase 2, PPARγ gene (PPARG), and sterol regulatory element binding transcription factor 1] according to evidence about biologic plausibility for interactions with dietary fat in weight regulation. Diet was assessed at baseline, and anthropometry was followed for 7 y.

RESULTS: The ORs for being a BW gainer for the 27 genetic variants ranged from 0.87 (95% CI: 0.79, 1.03) to 1.12 (95% CI: 0.96, 1.22) per additional minor allele. Uncorrected, CEBPB rs4253449 had a significant interaction with the intake of total fat and subgroups of fat. The OR for being a BW gainer for each additional rs4253449 minor allele per 100 kcal higher total fat intake was 1.07 (95% CI: 1.02, 1.12; P = 0.008), and similar associations were found for subgroups of fat.

CONCLUSIONS: Among European men and women, the influence of dietary fat on associations between SNPs in the PPARγ pathway and anthropometry is likely to be absent or marginal. The observed interaction between rs4253449 and dietary fat needs confirmation.

Originalsprog Engelsk
Tidsskrift The Journal of Nutrition
Vol/bind 146
Tidsskriftsnummer 3
Sider (fra-til) 603-11
Antal sider 9
DOI
Status Udgivet - mar. 2016

OBJECTIVE: This study examined the influence of weight loss on long-term morbidity and mortality in overweight (BMI≥25kg/m2) patients with type 2 diabetes, and tested the hypothesis that therapeutic intentional weight loss supervised by a medical doctor prolongs life and reduces the risk for cardiovascular disease in these patients.

METHODS: This is a 19 year cohort study of patients in the intervention arm of the randomized clinical trial Diabetes Care in General Practice. Weight and prospective intentions for weight loss were monitored every third month for six years in 761 consecutive patients (≥40 years) newly diagnosed with diabetes in general practices throughout Denmark in 1989-92. Multivariable Cox regression was used to estimate the association between weight change during the monitoring period (year 0 to 6) and the outcomes during the succeeding 13 years (year 6 to 19) in 444 patients who were overweight at diagnosis and alive at the end of the monitoring period (year 6). The analysis was adjusted for age, sex, education, BMI at diagnosis, change in smoking, change in physical activity, change in medication, and the Charlson comorbidity 6-year score. Outcomes were from national registers.

RESULTS: Overall, weight loss regardless of intention was an independent risk factor for increased all-cause mortality (P<0.01). The adjusted hazard ratio for all-cause mortality, cardiovascular mortality, and cardiovascular morbidity attributable to an intentional weight loss of 1 kg/year was 1.20 (95%CI 0.97-1.50, P = 0.10), 1.26 (0.93-1.72, P = 0.14), and 1.06 (0.79-1.42, P = 0.71), respectively. Limiting the analysis to include only those patients who survived the first 2 years after the monitoring period did not substantially change these estimates. A non-linear spline estimate indicated a V-like association between weight change and all-cause mortality, suggesting the best prognosis for those who maintained their weight.

CONCLUSIONS: In this population-based cohort of overweight patients with type 2 diabetes, successful therapeutic intentional weight loss, supervised by a doctor over six years, was not associated with reduced all-cause mortality or cardiovascular morbidity/mortality during the succeeding 13 years.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 11
Tidsskriftsnummer 1
Sider (fra-til) e0146889
ISSN 1932-6203
DOI
Status Udgivet - 2016

BACKGROUND: Intake of sugar-sweetened beverages is associated with obesity, and this association may be modified by a genetic predisposition to obesity.

OBJECTIVE: We examined the interactions between a molecular genetic predisposition to various aspects of obesity and the consumption of soft drinks, which are a major part of sugar-sweetened beverages, in relation to changes in adiposity measures.

DESIGN: A total of 4765 individuals were included in the study. On the basis of 50 obesity-associated single nucleotide polymorphisms that are associated with body mass index (BMI), waist circumference (WC), or the waist-to-hip ratio adjusted for BMI (WHRBMI), the following 4 genetic predisposition scores (GRSs) were constructed: a complete genetic predisposition score including all 50 single nucleotide polymorphisms (GRSComplete), a genetic predisposition score including BMI-associated single nucleotide polymorphisms (GRSBMI), a genetic predisposition score including waist circumference-associated single nucleotide polymorphisms (GRSWC), and a genetic predisposition score including the waist-to-hip ratio adjusted for BMI-associated single nucleotide polymorphisms (GRSWHR). Associations between soft drink intake and the annual change (Δ) in body weight (BW), WC, or waist circumference adjusted for BMI (WCBMI) and possible interactions with the GRSs were examined with the use of linear regression analyses and meta-analyses.

RESULTS: For each soft drink serving per day, soft drink consumption was significantly associated with a higher ΔBW of 0.07 kg/y (95% CI: 0.01, 0.13 kg/y; P = 0.020) but not with the ΔWC or ΔWCBMI In analyses of the ΔBW, we showed an interaction only with the GRSWC (per risk allele for each soft drink serving per day: -0.06 kg/y; 95% CI: -0.10, -0.02 kg/y; P = 0.006). In analyses of the ΔWC, we showed interactions only with the GRSBMI and GRSComplete [per risk allele for each soft drink serving per day: 0.05 cm/y (95% CI: 0.02, 0.09 cm/y; P = 0.001) and 0.05 cm/y (95% CI: 0.02, 0.07 cm/y; P = 0.001), respectively]. Nearly identical results were observed in analyses of the ΔWCBMI CONCLUSIONS: A genetic predisposition to a high WC may attenuate the association between soft drink intake and BW gain. A genetic predisposition to high BMI as well as a genetic predisposition to high BMI, WC, and WHRBMI combined may strengthen the association between soft drink intake and WC gain. However, the public health impact may be limited.

Originalsprog Engelsk
Tidsskrift The American journal of clinical nutrition
Vol/bind 104
Tidsskriftsnummer 3
Sider (fra-til) 816-26
Antal sider 11
ISSN 0002-9165
DOI
Status Udgivet - sep. 2016

OBJECTIVE: To assess the effects of one intra-articular corticosteroid injection two weeks prior to an exercise-based intervention program for reducing pain sensitivity in patients with knee osteoarthritis (OA).

DESIGN: Randomized, masked, parallel, placebo-controlled trial involving 100 participants with clinical and radiographic knee OA that were randomized to one intra-articular injection on the knee with either 1 ml of 40 mg/ml methylprednisolone (corticosteroid) dissolved in 4 ml lidocaine (10 mg/ml) or 1 ml isotonic saline (placebo) mixed with 4 ml lidocaine (10 mg/ml). Two weeks after the injections all participants undertook a 12-week supervised exercise program. Main outcomes were changes from baseline in pressure-pain sensitivity (pressure-pain threshold [PPT] and temporal summation [TS]) assessed using cuff pressure algometry on the calf. These were exploratory outcomes from a randomized controlled trial.

RESULTS: A total of 100 patients were randomized to receive either corticosteroid (n = 50) or placebo (n = 50); 45 and 44, respectively, completed the trial. Four participants had missing values for PPT and one for TS at baseline; thus modified intention-to-treat populations were analyzed. The mean group difference in changes from baseline at week 14 was 0.6 kPa (95% CI: -1.7 to 2.8; P = 0.626) for PPT and 384 mm×sec (95% CI: -2980 to 3750; P = 0.821) for TS.

CONCLUSIONS: These results suggest that adding intra-articular corticosteroid injection 2 weeks prior to an exercise program does not provide additional benefits compared to placebo in reducing pain sensitivity in patients with knee OA.

TRIAL REGISTRATION: EU clinical trials (EudraCT): 2012-002607-18.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 11
Tidsskriftsnummer 2
Sider (fra-til) e0149168
ISSN 1932-6203
DOI
Status Udgivet - 2016

BACKGROUND: Experience and development of pain may be influenced by a number of physiological, psychological, and psychosocial factors. In a previous study we found differences in neuronal activation to noxious stimulation, and microstructural neuroanatomical differences, when comparing healthy volunteers with differences in size of the area of secondary hyperalgesia following a standardized burn injury.

OBJECTIVE: We aim to investigate the degree of association between the volume of pain-relevant structures in the brain and the size of the area of secondary hyperalgesia following brief thermal sensitization.

METHODS: The study consists of one experimental day, in which whole-brain magnetic resonance imaging (MRI) scans will be conducted including T1-weighed three-dimensional anatomy scan, diffusion tensor imaging, and resting state functional MRI. Before the experimental day, all included participants will undergo experimental pain testing in a parallel study (Clinicaltrials.gov Identifier: NCT02527395). Results from this experimental pain testing, as well as the size of the area of secondary hyperalgesia from the included participants, will be extracted from this parallel study.

RESULTS: The association between the volume of pain-relevant structures in the brain and the area of secondary hyperalgesia will be investigated by linear regression of the estimated best linear unbiased predictors on the individual volumes of the pain relevant brain structures.

CONCLUSIONS: We plan to investigate the association between experimental pain testing parameters and the volume, connectivity, and resting state activity of pain-relevant structures in the brain. These results may improve our knowledge of the mechanisms responsible for the development of acute and chronic pain.

CLINICALTRIAL: Danish Research Ethics Committee (identifier: H-15010473). Danish Data Protection Agency (identifier: RH-2015-149). Clinicaltrials.gov NCT02567318; http://clinicaltrials.gov/ct2/show/NCT02567318 (Archived by WebCite at http://www.webcitation.org/6i4OtP0Oi).

Originalsprog Engelsk
Tidsskrift JMIR research protocols
Udgivelsesdato 2016
Vol/bind 5
Tidsskriftsnummer 2
Sider e117
DOI
Status Udgivet

Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties

Collins, N. J., Prinsen, C. A. C., Christensen, R., Bartels, E. M., Terwee, C. B. & Roos, E. M. aug. 2016 I : Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society. 24, 8, s. 1317-29 13 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To conduct a systematic review and meta-analysis to synthesize evidence regarding measurement properties of the Knee injury and Osteoarthritis Outcome Score (KOOS).

DESIGN: A comprehensive literature search identified 37 eligible papers evaluating KOOS measurement properties in participants with knee injuries and/or osteoarthritis (OA). Methodological quality was evaluated using the COSMIN checklist. Where possible, meta-analysis of extracted data was conducted for all studies and stratified by age and knee condition; otherwise narrative synthesis was performed.

RESULTS: KOOS has adequate internal consistency, test-retest reliability and construct validity in young and old adults with knee injuries and/or OA. The ADL subscale has better content validity for older patients and Sport/Rec for younger patients with knee injuries, while the Pain subscale is more relevant for painful knee conditions. The five-factor structure of the original KOOS is unclear. There is some evidence that the KOOS subscales demonstrate sufficient unidimensionality, but this requires confirmation. Although measurement error requires further evaluation, the minimal detectable change for KOOS subscales ranges from 14.3 to 19.6 for younger individuals, and ≥20 for older individuals. Evidence of responsiveness comes from larger effect sizes following surgical (especially total knee replacement) than non-surgical interventions.

CONCLUSIONS: KOOS demonstrates adequate content validity, internal consistency, test-retest reliability, construct validity and responsiveness for age- and condition-relevant subscales. Structural validity, cross-cultural validity and measurement error require further evaluation, as well as construct validity of KOOS Physical function Short form. Suggested order of subscales for different knee conditions can be applied in hierarchical testing of endpoints in clinical trials.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42011001603).

Originalsprog Engelsk
Tidsskrift Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Vol/bind 24
Tidsskriftsnummer 8
Sider (fra-til) 1317-29
Antal sider 13
ISSN 1063-4584
DOI
Status Udgivet - aug. 2016
Originalsprog Dansk
Udgivelses sted København
Vol/bind 1
Udgave 1
Status Udgivet - 28 okt. 2016

Lean body mass change over 6 years is associated with dietary leucine intake in an older Danish population

McDonald, C. K., Ankarfeldt, M. Z., Capra, S., Bauer, J., Raymond, K. & Heitmann, B. L. maj 2016 I : The British journal of nutrition. 115, 9, s. 1556-62 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

Higher protein intake, and particularly higher leucine intake, is associated with attenuated loss of lean body mass (LBM) over time in older individuals. Dietary leucine is thought to be a key mediator of anabolism. This study aimed to assess this relationship over 6 years among younger and older adult Danes. Dietary leucine intake was assessed at baseline and after 6 years in men and women, aged 35-65 years, participating in the Danish cohort of the WHO-MONICA (Multinational MONItoring of trends and determinants in CArdiovascular disease) study (n 368). Changes in LBM over the 6 years were measured by bioelectrical impedance using equations developed for this Danish population. The association between leucine and LBM changes was examined using multivariate linear regression and ANCOVA analyses adjusted for potential confounders. After adjustment for baseline LBM, sex, age, energy intake and physical activity, leucine intake was associated with LBM change in those older than 65 years (n 79), with no effect seen in those younger than 65 years. Older participants in the highest quartile of leucine intake (7·1 g/d) experienced LBM maintenance, whereas lower intakes were associated with LBM loss over 6 years (for trend: β=0·434, P=0·03). Sensitivity analysis indicated no effect modification of sex or the presence of CVD. Greater leucine intake in conjunction with adequate total protein intake was associated with long-term LBM retention in a healthy older Danish population. This study corroborates findings from laboratory investigations in relation to protein and leucine intakes and LBM change. A more diverse and larger sample is needed for confirmation of these results.

Originalsprog Engelsk
Tidsskrift The British journal of nutrition
Vol/bind 115
Tidsskriftsnummer 9
Sider (fra-til) 1556-62
Antal sider 7
ISSN 0007-1145
DOI
Status Udgivet - maj 2016

BACKGROUND: Stretching is often used in clinical practice for a variety of purposes, including pain therapy. The possible mechanism behind the effect of stretching remains to be clarified.

AIM: To investigate whether 4 weeks of unilateral stretching of the calf muscles would affect local and central pain sensitivity.

METHOD: This study was a randomized assessor-blinded clinical study. Healthy participants (age 18 to 40) were included and randomized. Participants in the intervention group were instructed to perform 2 stretching exercises targeting the calf muscles; 3 times 30 seconds, 7 days a week for 4 weeks on the dominant leg. Participants in the control group were instructed not to do any stretching for 4 weeks. Pressure pain threshold (PPT) and temporal summation (TS) of pressure pain were measured on the stretched calf, the contra-lateral calf, and contra-lateral lower arm using a computerized cuff algometer. Analyses of variance on the per-protocol population (defined as participants that adhered to the protocol) were used to assess group differences in the changes from baseline.

RESULT: Forty healthy volunteers were included, of which 34 participants adhered to the protocol (15 intervention group/19 control group). No statistically significant group differences in the changes from baseline were found regarding PPT and TS measurements for the stretched calf, the contra-lateral calf, and the arm.

CONCLUSION: Four weeks of regular stretching of the calf muscles does not affect pressure pain sensitivity, suggesting that pressure pain sensitivity is unaffected by stretching in a healthy population. The mechanisms underlying any benefits of regular stretching remain to be explained.

Originalsprog Engelsk
Tidsskrift Pain practice : the official journal of World Institute of Pain
ISSN 1530-7085
DOI
Status Udgivet - 6 jul. 2016

BACKGROUND: Weight reduction may reduce the severity of psoriasis, but little is known about the long-term effects.

OBJECTIVE: We aimed to investigate long-term effects of weight reduction in psoriasis.

DESIGN: We previously conducted a randomized trial (n = 60) involving patients with psoriasis who were allocated to a control group or a low-energy diet (LED) group. Here we followed the participants for an additional 48-wk period. In total, 56 patients with psoriasis [mean ± SD body mass index (in kg/m(2)): 34.4 ± 5.3] underwent a 64-wk weight-loss program consisting of an initial 16-wk randomized phase with an LED for 8 wk and 8 wk of normal food intake combined with 2 LED products/d, followed by a 48-wk period of weight maintenance with the latter diet. After the randomization phase, the control group received the same 8 + 8-wk LED intervention, and all patients were then followed for 48 wk while on the weight-loss maintenance diet. The main outcome was the Psoriasis Area and Severity Index (PASI), and secondary outcome was the Dermatology Life Quality Index (DLQI).

RESULTS: For the present study, 56 patients were eligible, 38 agreed to participate, and 32 completed. After the 16-wk LED-only period, the mean weight loss was -15.0 kg (95% CI: -16.6, -13.4 kg), and PASI and DLQI were reduced by -2.3 (95% CI: -3.1, -1.5) and -2.3 (95% CI: -3.2, -1.4), respectively. At week 64, the mean weight loss compared with baseline was -10.1 kg (95% CI: -12.0, -8.1 kg), and PASI and DLQI were maintained at -2.9 (95% CI: -3.9, -1.9) and -1.9 (95% CI: -3.0, -0.9), respectively.

CONCLUSION: Long-term weight loss in patients with psoriasis has long-lasting positive effects on the severity of psoriasis. This trial was registered at clinicaltrials.gov as NCT01137188.

Originalsprog Engelsk
Tidsskrift The American journal of clinical nutrition
Vol/bind 104
Tidsskriftsnummer 2
Sider (fra-til) 259-65
Antal sider 7
ISSN 0002-9165
DOI
Status Udgivet - aug. 2016

Maternal serum retinol and β-carotene concentrations and neonatal bone mineralization: results from the Southampton Women's Survey cohort

Händel, M. N., Moon, R. J., Titcombe, P., Abrahamsen, B., Heitmann, B. L., Calder, P. C., Dennison, E. M., Robinson, S. M., Godfrey, K. M., Inskip, H. M., Cooper, C. & Harvey, N. C. okt. 2016 I : The American journal of clinical nutrition. 104, 4, s. 1183-1188 6 s.

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Studies in older adults and animals have suggested contrasting relations between bone health and different vitamin A compounds. To our knowledge, the associations between maternal vitamin A status and offspring bone development have not previously been elucidated.

OBJECTIVE: We examined the associations between maternal serum retinol and β-carotene concentrations during late pregnancy and offspring bone mineralization assessed at birth with the use of dual-energy X-ray absorptiometry.

DESIGN: In the Southampton Women's Survey mother-offspring birth cohort, maternal health, lifestyle, and diet were assessed prepregnancy and at 11 and 34 wk of gestation. In late pregnancy, maternal serum retinol and β-carotene concentrations were measured. Offspring total body bone mineral density (BMD), bone mineral content (BMC), and bone area (BA) were measured within 2 wk after birth.

RESULTS: In total, 520 and 446 mother-offspring pairs had measurements of maternal serum retinol and β-carotene, respectively. Higher maternal serum retinol in late pregnancy was associated with lower offspring total body BMC (β = -0.10 SD/SD; 95% CI: -0.19, -0.02; P = 0.020) and BA (β = -0.12 SD/SD; 95% CI: -0.20, -0.03; P = 0.009) but not BMD. Conversely, higher maternal serum β-carotene concentrations in late pregnancy were associated with greater total body BMC (β = 0.12 SD/SD; 95% CI: 0.02, 0.21; P = 0.016) and BA (β = 0.12 SD/SD; 95% CI: 0.03, 0.22; P = 0.010) but not BMD.

CONCLUSIONS: Maternal serum retinol and β-carotene concentrations had differing associations with offspring bone size and growth at birth: retinol was negatively associated with these measurements, whereas β-carotene was positively associated. These findings highlight the need for further investigation of the effects of maternal retinol and carotenoid status on offspring bone development.

Originalsprog Engelsk
Tidsskrift The American journal of clinical nutrition
Vol/bind 104
Tidsskriftsnummer 4
Sider (fra-til) 1183-1188
Antal sider 6
ISSN 0002-9165
DOI
Status Udgivet - okt. 2016

Modified intention-to-treat analysis did not bias trial results

Dossing, A., Tarp, S., Furst, D. E., Gluud, C., Wells, G. A., Beyene, J., Hansen, B. B., Bliddal, H. & Christensen, R. 2016 I : Journal of Clinical Epidemiology. 72, s. 66-74

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To investigate whether analysis of the modified intention-to-treat (mITT) population with post-randomisation exclusion of patients from analysis is associated with biased estimates of treatment effect compared to the conservative intention-to-treat (ITT) population.

STUDY DESIGN AND SETTING: Placebo-controlled, blinded randomised trials on biological or targeted interventions for rheumatoid arthritis were identified through a systematic search. Two authors independently extracted data. A random-effects meta-analysis was used to combine odds ratios as an expression of treatment effect and stratify according to the different analysis populations.

RESULTS: Seventy-two randomised trials were included and analysed (23,842 patients). Thirty trials analysed the ITT population, 37 analysed an mITT population, and 5 trials had an unclear analysis population. The treatment effect of active intervention compared to control, when based on mITT, was comparable to ITT (odds ratio 3.76 [95% confidence interval 3.09 to 4.57], and 3.47 [2.77 to 4.34]; comparison P=0.60).

CONCLUSION: We found no difference in the treatment effect between randomised trials using ITT and mITT analyses populations. This suggests that the mITT approach in rheumatoid arthritis trials investigating biological or targeted interventions does not introduce bias compared to ITT.

Originalsprog Engelsk
Tidsskrift Journal of Clinical Epidemiology
Vol/bind 72
Sider (fra-til) 66-74
ISSN 0895-4356
DOI
Status Udgivet - 2016

Mortality in ankylosing spondylitis: results from a nationwide population-based study

Exarchou, S., Lie, E., Lindström, U., Askling, J., Forsblad-d'Elia, H., Turesson, C., Kristensen, L. E. & Jacobsson, L. T. aug. 2016 I : Annals of the Rheumatic Diseases. 75, 8, s. 1466-72 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: Information on mortality in ankylosing spondylitis (AS) is scarce. Our study therefore aimed to assess: (1) mortality in AS versus the general population, and (2) predictors of death in the AS population.

METHODS: Nationwide cohorts of patients with AS diagnosed at rheumatology or internal medicine outpatient clinics (n=8600) and age-matched, sex-matched and county-matched general population comparators (n=40 460) were identified from the National Patient Register and the census register, respectively. The follow-up period began on 1 January 2006 or at the first date of registered diagnosis thereafter and extended until death, emigration or 31 December 2012, whichever occurred first. Socioeconomic variables, AS-related clinical manifestations, joint surgery, comorbidities and medication were identified from other national registers. Cox regression models were used to determine mortality and predictors for death in the AS cohort.

RESULTS: There were 496 deaths in the AS cohort and 1533 deaths in the control cohort resulting in an age-adjusted and sex-adjusted HR of 1.60 (95% CI 1.44 to 1.77), with increased mortality for men (age-adjusted HR=1.53, 95% CI 1.36 to 1.72) and women (age-adjusted HR=1.83, 95% CI 1.50 to 2.22). Within the AS cohort, statistically significant predictors for death were a lower level of education, general comorbidities (diabetes, infections, cardiovascular, pulmonary and malignant diseases) and previous hip replacement surgery.

CONCLUSIONS: Mortality was increased for male and female patients with AS. Predictors of death within the AS cohort included socioeconomic status, general comorbidities and hip replacement surgery.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 75
Tidsskriftsnummer 8
Sider (fra-til) 1466-72
Antal sider 7
ISSN 0003-4967
DOI
Status Udgivet - aug. 2016

Motivational Interviewing to Prevent Childhood Obesity: A Cluster RCT

Döring, N., Ghaderi, A., Bohman, B., Heitmann, B. L., Larsson, C., Berglind, D., Hansson, L., Sundblom, E., Magnusson, M., Blennow, M., Tynelius, P., Forsberg, L. & Rasmussen, F. maj 2016 I : Pediatrics. 137, 5

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: The objective was to evaluate a manualized theory-driven primary preventive intervention aimed at early childhood obesity. The intervention was embedded in Swedish child health services, starting when eligible children were 9 to 10 months of age and continuing until the children reached age 4.

METHODS: Child health care centers in 8 Swedish counties were randomized into intervention and control units and included 1355 families with 1369 infants. Over ∼39 months, families in the intervention group participated in 1 group session and 8 individual sessions with a nurse trained in motivational interviewing, focusing on healthy food habits and physical activity. Families in the control group received care as usual. Primary outcomes were children's BMI, overweight prevalence, and waist circumference at age 4. Secondary outcomes were children's and mothers' food and physical activity habits and mothers' anthropometrics. Effects were assessed in linear and log-binominal regression models using generalized estimating equations.

RESULTS: There were no statistically significant differences in children's BMI (β = -0.11, 95% confidence interval [CI]: -0.31 to 0.08), waist circumference (β = -0.48, 95% CI: -0.99 to 0.04), and prevalence of overweight (relative risk = 0.95, 95% CI: 0.69 to 1.32). No significant intervention effects were observed in mothers' anthropometric data or regarding mothers' and children's physical activity habits. There was a small intervention effect in terms of healthier food habits among children and mothers.

CONCLUSIONS: There were no significant group differences in children's and mothers' anthropometric data and physical activity habits. There was, however, some evidence suggesting healthier food habits, but this should be interpreted with caution.

Originalsprog Engelsk
Tidsskrift Pediatrics
Vol/bind 137
Tidsskriftsnummer 5
ISSN 0031-4005
DOI
Status Udgivet - maj 2016

Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

Svensson, A. L., Christensen, R., Persson, F., Løgstrup, B. B., Giraldi, A., Graugaard, C., Fredberg, U., Blegvad, J., Thygesen, T., Hansen, I. M. J., Colic, A., Bagdat, D., Ahlquist, P., Jensen, H. S., Hørslev-Petersen, K., Sheetal, E., Christensen, T. G., Svendsen, L., Emmertsen, H. & Ellingsen, T. 2016 I : B M J Open. 6, 4, s. e009134

Publikation: Forskning - peer reviewTidsskriftartikel

INTRODUCTION: Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria.

METHODS AND ANALYSIS: The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia and (4) microalbuminuria (intervention group).

ETHICS AND DISSEMINATION: This protocol is approved by the local ethics committee (DK-S-2014007) and The Danish Health and Medicines Authority. Dissemination will occur through presentations at National and International conferences and publications in international peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT02246257.

Originalsprog Engelsk
Tidsskrift B M J Open
Vol/bind 6
Tidsskriftsnummer 4
Sider (fra-til) e009134
ISSN 2044-6055
DOI
Status Udgivet - 2016

Muscle Contraction Revised: Combining Contraction Models with Present Scientific Research Evidence

Bartels, E. M. 2016 Muscle Contraction and Cell Motility: Fundamentals and Developments. Sugi, H. (red.). 1 udg. Singapore, Vol. 1, Kap. 3, s. 73-114 41 s.

Publikation: Forskning - peer reviewBidrag til bog/antologi

Originalsprog Engelsk
Titel Muscle Contraction and Cell Motility : Fundamentals and Developments
Redaktører Haruo Sugi
Antal sider 41
Vol/bind 1
Udgivelses sted Singapore
Publikationsdato 2016
Udgave 1
Sider 73-114
Kapitel 3
ISBN (trykt) 978-981-4745-16-1
ISBN (elektronisk) 978-981-4745-17-8
Status Udgivet - 2016

OBJECTIVE: To examine intraobserver, interobserver and between-day reproducibility of positional MRI for evaluation of navicular bone height (NVH) and medial navicular position (MNP).

MATERIALS AND METHODS: Positional MRI (pMRI) of the foot was performed on ten healthy participants (0.25 T G-scanner). Scanning was performed in supine and standing position, respectively. Two radiologists evaluated the images in a blinded manner. Reliability and agreement were assessed by calculation of intraclass correlation coefficient (ICC) and 95 % limits of agreement as a percentage of the mean (LOA%).

RESULTS: Intraobserver and interobserver reliability was "substantial" in both supine and standing position (ICC 0.86-0.98) and showed good agreement (LOA% 4.9-14.7 %). Between-day reliability of navicular height and medial navicular position in standing position remained substantial (ICC 0.85-0.92) with adequate agreement (LOA% 8.3-19.8 %). In supine position between-day reliability was "moderate" for NVH (ICC 0.72) and "slight" for MNP (ICC 0.39). Agreement remained adequate between-days for MNP in supine position (LOA% 17.7 %), but it was less than adequate for NVH in supine position (LOA% 24.2 %).

CONCLUSION: Navicular height and medial navicular position can be measured by pMRI in a very reproducible manner within and between observers. Increased measurement variation is observed between-days in supine position, which may be due to small positional differences or other unknown biomechanical factors.

Originalsprog Engelsk
Tidsskrift Skeletal radiology
Vol/bind 45
Tidsskriftsnummer 2
Sider (fra-til) 205-11
Antal sider 7
ISSN 0364-2348
DOI
Status Udgivet - feb. 2016

Neonatal vitamin D status is not associated with later risk of type 1 diabetes: results from two large Danish population-based studies

Jacobsen, R., Thorsen, S. U., Cohen, A. S., Lundqvist, M., Frederiksen, P., Pipper, C. B., Pociot, F., Thygesen, L. C., Ascherio, A., Svensson, J. & Heitmann, B. L. sep. 2016 I : Diabetologia. 59, 9, s. 1871-81 11 s.

Publikation: Forskning - peer reviewTidsskriftartikel

AIMS/HYPOTHESIS: The aim of this work was to assess whether neonatal levels of 25-hydroxyvitamin D (25(OH)D) are associated with risk of developing type 1 diabetes before the age of 18 years.

METHODS: Two large-scale studies with different designs-a case-cohort and a case-control-were conducted using Danish national register data and biobank material. Weighted Cox regression and conditional logistic regression were used to calculate HRs and ORs, respectively. The concentration of 25(OH)D was assessed from neonatal dried blood spots using highly sensitive liquid chromatography-tandem mass spectrometry. Quintiles of 25(OH)D3 were used in the main analyses.

RESULTS: The case-cohort study included 912 type 1 diabetes cases and 2866 individuals without type 1 diabetes born in Denmark between 1981 and 2002 and followed up until the end of 2012. The case-control study included 527 matched case-control pairs born between 1981 and 1999 and followed up until May 2004. Both studies found no association between 25(OH)D3 levels and later risk of developing type 1 diabetes. The neonatal total 25(OH)D levels in the studies were low: 46% (case-cohort study) and 51% (case-control study) of individuals had 25(OH)D levels <25 nmol/l.

CONCLUSIONS/INTERPRETATION: Our two large-scale national studies showed that 25(OH)D3 levels around the time of birth were not associated with later type 1 diabetes risk. Whether higher levels of 25(OH)D3 during pregnancy, acquired by higher doses of supplementation than are recommended today in most countries, could protect the offspring against type 1 diabetes cannot be ruled out by the present studies.

Originalsprog Engelsk
Tidsskrift Diabetologia
Vol/bind 59
Tidsskriftsnummer 9
Sider (fra-til) 1871-81
Antal sider 11
ISSN 0012-186X
DOI
Status Udgivet - sep. 2016

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