Published in 2017

Neonatal Vitamin D Levels in Relation to Risk of Overweight at 7 Years in the Danish D-Tect Case-Cohort Study

Jensen, C. B., Lundqvist, M., Sørensen, T. I. A. & Heitmann, B. L. 10 jun. 2017 I : Obesity Facts. 10, 3, s. 273-283 11 s.

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Vitamin D level in pregnancy may be associated with risk of overweight in the offspring later in life.

METHODS: In a case-cohort study based on Danish biobanks and registers we examined the association between 25-hydroxy-vitamin D (25(OH)D) level at birth and overweight at 7 years. Cases of overweight (n = 871) were randomly selected among 7-year-old children from the Copenhagen School Health Records Register (CSHRR) with a BMI above the 90th percentile. The cohort (n = 1,311) was a random sample selected among all Danish children born during the same period. Neonatal 25(OH)D was measured in dried blood spots.

RESULTS: 25(OH)D3 exhibited the expected seasonal variation. Median level of 25(OH)D3 was 20.6 (11.9-33.3) nmol/l in the overweight group and 23.4 (13.5-34.3) nmol/l in the cohort. We found no association between neonatal 25(OH)D3 level and risk of overweight at age 7 years, neither in the crude model (OR (CI) 1.00 (0.99; 1.00)) nor in a model adjusted for maternal ethnicity, educational level, civil status, parity, season and year of birth, and offspring ponderal index (OR (CI) 1.00 (0.99; 1.01)).

CONCLUSION: Risk of overweight at 7 years of age was not associated with vitamin D level at birth.

Originalsprog Engelsk
Tidsskrift Obesity Facts
Vol/bind 10
Tidsskriftsnummer 3
Sider (fra-til) 273-283
Antal sider 11
ISSN 1662-4025
DOI
Status Udgivet - 10 jun. 2017

Background: Whether antenatal and neonatal vitamin D status have clinical relevance in fracture prevention has not been examined extensively, although observational studies indicate that fetal life may be a sensitive period in relation to bone growth and mineralization during childhood.Objective: We examined whether 25-hydroxyvitamin D3 [25(OH)D3] concentrations in stored neonatal dried blood spot (DBS) samples are associated with pediatric fracture risk. We hypothesized that in particular, low neonatal vitamin D status may be a risk factor for fracture incidence among children.Design: In a register-based case-cohort study design, the case group was composed of 1039 individuals who were randomly selected from a total of 82,154 individuals who were born during 1989-1999 and admitted to a Danish hospital with a fracture of the forearm, wrist, scaphoid bone, clavicle, or ankle at age 6-13 y. The subcohort was composed of 1600 individuals randomly selected from all Danish children born during 1989-1999. The neonatal 25(OH)D3 concentrations in DBS samples were assessed by using highly sensitive chromatography-tandem mass spectrometry.Results: The mean ± SD 25(OH)D3 concentration for all subjects was 27.7 ± 18.9 nmol/L [median (IQR): 23.5 nmol/L (13.3, 37.3 nmol/L)] and showed significant monthly variation (P < 0.0001) with the highest values in July and August. Individuals in the middle quintile of neonatal 25(OH)D3 had lower odds of sustaining a fracture than did those in the lowest quintile (adjusted OR: 0.75; 95% CI: 0.58, 0.96), but a global test did not show any significant overall association (adjusted P = 0.13).Conclusions: This study suggested that neonatal vitamin D status does not influence subsequent fracture risk in childhood. This is in accordance with studies that report no association between antenatal maternal vitamin D status and childhood fractures. Further studies are needed to examine fracture risk in relation to prenatal vitamin D status in a randomized controlled setting.

Originalsprog Engelsk
Tidsskrift The American journal of clinical nutrition
ISSN 0002-9165
DOI
Status Udgivet - 17 maj 2017

New perspectives on the development of muscle contractures following central motor lesions

Pingel, J., Bartels, E. M. & Nielsen, J. B. 15 feb. 2017 I : Journal of Physiology. 595, 4, s. 1027-1038 12 s.

Publikation: Forskning - peer reviewReview

Muscle contractures are common in patients with central motor lesions, but the mechanisms responsible for the development of contractures are still unclear. Increased or decreased neural activation, protracted placement of a joint with the muscle in a short position and muscle atrophy have been suggested to be involved, but none of these mechanisms are sufficient to explain the development of muscle contractures alone. Here we propose that changes in tissue homeostasis in the neuromuscular–tendon–connective tissue complex is at the heart of the development of contractures, and that an integrated physiological understanding of the interaction between neural, mechanical and metabolic factors, as well as genetic and epigenetic factors, is necessary in order to unravel the mechanisms that result in muscle contractures. We hope thereby to contribute to a reconsideration of how and why muscle contractures develop in a way which will open a window towards new insight in this area in the future. (Figure presented.).

Originalsprog Engelsk
Tidsskrift Journal of Physiology
Vol/bind 595
Tidsskriftsnummer 4
Sider (fra-til) 1027-1038
Antal sider 12
ISSN 0022-3751
DOI
Status Udgivet - 15 feb. 2017

Oral Lactobacillus Counts Predict Weight Gain Susceptibility: A 6-Year Follow-Up Study

Rosing, J. A., Walker, K. C., Jensen, B. A. H. & Heitmann, B. L. 2017 I : Obesity Facts. 10, 5, s. 473-482 10 s.

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Recent studies have shown an association between weight change and the makeup of the intestinal microbiota in humans. Specifically, Lactobacillus, a part of the entire gastrointestinal tract's microbiota, has been shown to contribute to weight regulation.

AIM: We examined the association between the level of oral Lactobacillus and the subsequent 6-year weight change in a healthy population of 322 Danish adults aged 35-65 years at baseline.

DESIGN: Prospective observational study.

RESULTS: In unadjusted analysis the level of oral Lactobacillus was inversely associated with subsequent 6-year change in BMI. A statistically significant interaction between the baseline level of oral Lactobacillus and the consumption of complex carbohydrates was found, e.g. high oral Lactobacillus count predicted weight loss for those with a low intake of complex carbohydrates, while a medium intake of complex carbohydrates predicted diminished weight gain. A closer examination of these relations showed that BMI change and Lactobacillus level was unrelated for those with high complex carbohydrate consumption.

CONCLUSION: A high level of oral Lactobacillus seems related to weight loss among those with medium and low intakes of complex carbohydrates. Absence, or a low level of oral Lactobacillus, may potentially be a novel marker to identify those at increased risk of weight gain.

Originalsprog Engelsk
Tidsskrift Obesity Facts
Vol/bind 10
Tidsskriftsnummer 5
Sider (fra-til) 473-482
Antal sider 10
ISSN 1662-4025
DOI
Status Udgivet - 2017

PURPOSE: The current narrative review covers original research related to imaging in osteoarthritis (OA) in humans published in English between April 1st 2015 and March 31st 2016, in peer reviewed journals available in Medline via PubMed (http://www.ncbi.nlm.nih.gov/pubmed/).

METHODS: Relevant studies in humans, subjectively decided by the authors, contributing significantly to the OA imaging field, were selected from an extensive Medline search using the terms "Osteoarthritis" in combination with "MRI", "Imaging", "Radiography", "X-rays", "Ultrasound", "Computed tomography", "Nuclear medicine", "PET-CT", "PET-MRI", "Scintigraphy", "SPECT". Publications were sorted according to relevance for the OA imaging research community with an emphasis on high impact special interest journals using the software for systematic reviews www.covidence.org.

RESULTS: An overview of newly published studies compared to studies reported previous years is presented, followed by a review of selected imaging studies of primarily knee, hip and hand OA focussing on (1) results for detection of OA and OA-related pathology (2) studies dealing with treatments and (3) studies focussing on prognosis of disease progression or joint replacement. A record high number of 1420 articles were published, among others, of new technologies and tools for improved morphological and pathophysiological understanding of OA-related changes in joints. Also, imaging data were presented of monitoring treatment effect and prognosis of OA progression, primarily using established radiographic, magnetic resonance imaging (MRI), and ultrasound (US) methods.

CONCLUSION: Imaging continues to play an important role in OA research, where several exciting new technologies and computer aided analysis methods are emerging to complement the conventional imaging approaches.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and Cartilage
Vol/bind 25
Tidsskriftsnummer 2
Sider (fra-til) 216-226
Antal sider 11
ISSN 1063-4584
DOI
Status Udgivet - feb. 2017

Osteoarthritis: Time to put steroid injections behind us?

Bliddal, H. & Henriksen, M. jul. 2017 I : Nature reviews. Rheumatology. 13, 9, s. 519-520 2 s.

Publikation: Forskning - peer reviewTidsskriftartikel

Originalsprog Engelsk
Tidsskrift Nature reviews. Rheumatology
Vol/bind 13
Tidsskriftsnummer 9
Sider (fra-til) 519-520
Antal sider 2
DOI
Status Udgivet - jul. 2017

BACKGROUND: Central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The painDETECT questionnaire (PDQ) identifies neuropathic pain features, which may act as a proxy for centrally mediated pain. The objectives were to quantify and characterize pain phenotypes (non-neuropathic vs. neuropathic features) among Danish arthritis patients using the PDQ, and to assess the association with on-going inflammation.

METHODS: The PDQ was included onto the DANBIO touch screens at 22 departments of Rheumatology in Denmark for six months. Clinical data and patient reported outcomes were obtained from DANBIO. A PDQ-score >18 indicated neuropathic pain features, 13-18 unclear pain mechanism and <13 non-neuropathic pain.

RESULTS: Pain data (visual analogue scale, VAS) was available for 15,978 patients. 7,054 patients completed the PDQ (RA: 3,826, PsA: 1,180, SpA: 1,093). 52% of all patients and 63% of PDQ-completers had VAS pain score ≥ 30 mm. The distribution of the PDQ classification-groups (<13/ 13-18/ >18) were; RA: 56%/24%/20%. PsA: 45%/ 27%/ 28%. SpA: 55% / 24%/ 21%. More patients with PsA had PDQ score >18 compared to RA and SpA (p<0.001). For PDQ > 18 significantly higher scores were found for all patient reported outcomes and disease activity scores. No clinical difference in CRP or swollen joint count was found. Logistic regression showed increased odds for having VAS pain ≥39 mm (the median) for a PDQ-score >18 compared to <13 (OR = 10.4; 95%CI 8.6-12.5).

CONCLUSIONS: More than 50% of the Danish arthritis patients reported clinically significant pain. More than 20% of the PDQ-completers had indication of neuropathic pain features, which was related to a high pain-level. PDQ-score was associated with DAS28-CRP and VAS pain but not with indicators of peripheral inflammation (CRP and SJC). Thus, pain classification by PDQ may assist in mechanism-based pain treatment.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 12
Tidsskriftsnummer 7
Sider (fra-til) e0180014
ISSN 1932-6203
DOI
Status Udgivet - 2017

Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears: comparative prospective cohort study

Thorlund, J. B., Englund, M., Christensen, R., Nissen, N., Pihl, K., Jørgensen, U., Schjerning, J. & Lohmander, L. S. 2 feb. 2017 I : B M J (Online). 356, s. j356

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: To compare patient reported outcomes from before surgery to 52 weeks after surgery between individuals undergoing arthroscopic partial meniscectomy for traumatic meniscal tears and those for degenerative meniscal tears.

DESIGN: Comparative prospective cohort study.

SETTING: Four public orthopaedic departments in the Region of Southern Denmark. Participants were recruited between 1 February 2013 and 31 January 2014, and at one of the original four hospitals from 1 February 2014 to 31 January 2015.

PARTICIPANTS: Individuals selected from Knee Arthroscopy Cohort Southern Denmark, aged 18-55, and undergoing arthroscopic partial meniscectomy for a traumatic or degenerative meniscal tear (defined by a combination of age and symptom onset).

INTERVENTIONS: Both participant groups underwent arthroscopic partial meniscectomy for a meniscal tear, with operating surgeons recording relevant information on knee pathology. Patient reported outcomes were recorded via online questionnaires.

MAIN OUTCOME MEASURES: Primary outcome was the average between-group difference in change on four of five subscales of the knee injury and osteoarthritis outcome score (KOOS). The four subscales covered pain, symptoms, sport and recreational function, and quality of life (KOOS4). A 95% confidence interval excluding differences greater than 10 KOOS points between groups was interpreted as absence of a clinically meaningful difference. Analyses adjusted for age, sex, and body mass index.

RESULTS: 397 eligible adults (42% women) with a traumatic or degenerative meniscal tear (n=141, mean age 38.7 years (standard deviation 10.9); n=256, 46.6 years (6.4); respectively) were included in the main analysis. At 52 weeks after arthroscopic partial meniscectomy, 55 (14%) patients were lost to follow-up. Statistically, participants with degenerative meniscal tears had a significantly larger improvement in KOOS4 scores than those with traumatic tears (adjusted between-group difference -5.1 (95% confidence interval -8.9 to -1.3); P=0.008). In the analysis including KOOS4 score at all time points, a significant time-by-group interaction was observed in both the unadjusted (P=0.025) and adjusted analysis (P=0.024), indicating better self-reported outcomes in participants with degenerative tears. However, the difference between groups was at no time point considered clinically meaningful.

CONCLUSIONS: These results question the current tenet that patients with traumatic meniscal tears experience greater improvements in patient reported outcomes after arthroscopic partial meniscectomy than patients with degenerative tears.Trial registration ClinicalTrials.gov identifier NCT01871272.

Originalsprog Engelsk
Tidsskrift B M J (Online)
Vol/bind 356
Sider (fra-til) j356
ISSN 1756-1833
Status Udgivet - 2 feb. 2017

Physical activity, obesity and mortality: does pattern of physical activity have stronger epidemiological associations?

Bauman, A. E., Grunseit, A. C., Rangul, V. & Heitmann, B. L. 5 okt. 2017 I : BMC Public Health. 17, 1, s. 788

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Most studies of physical activity (PA) epidemiology use behaviour measured at a single time-point. We examined whether 'PA patterns' (consistently low, consistently high or inconsistent PA levels over time) showed different epidemiological relationships for anthropometric and mortality outcomes, compared to single time-point measure of PA.

METHODS: Data were the Danish MONICA (MONItoring Trends and Determinants in CArdiovascular Disease) study over three waves 1982-3 (time 1), 1987-8 (time 2) and 1993-4 (time 3). Associations between leisure time single time-point PA levels at time 1 and time 3, and sport and active travel at times 1 and 2 with BMI, waist, hip circumference and mortality (death from coronary heart disease (CHD) and cardiovascular disease (CVD)) were compared to 'PA patterns' spanning multiple time points. PA pattern classified participants' PA as either 1) inactive or low PA at both time points; 2) moderate level PA at time 1 and high activity at time 3; or 3) a 'mixed PA pattern' indicating a varying levels of activity over time. Similarly, sport and active travel were also classified as indicating stable low, stable high and mixed patterns.

RESULTS: The moderately and highly active groups for PA at times 1 and 3 had up to 1.7 cm lower increase in waist circumference compared with the inactive/low active group. Across 'PA patterns', 'active maintainers' had a 2.0 cm lower waist circumference than 'inactive/low maintainers'. Waist circumference was inversely related to sport but not active travel. CHD risk did not vary by activity levels at time 1, but was reduced significantly by 43% for high PA at time 3 (vs 'inactive' group) and among 'active maintainers' (vs 'inactive/low maintainers') by 62%. 'Sport pattern' showed stronger reductions in mortality for cardiovascular disease and CHD deaths among sport maintainers, than the single time point measures.

CONCLUSIONS: PA patterns demonstrated a stronger association with a number of anthropometric and mortality outcomes than the single time-point measures. Operationalising PA as a sustained behavioural pattern may address some of the known under-estimation of risk for poor health in PA self-report measurements and better reflect exposure for epidemiological analysis of risk of health outcomes.

Originalsprog Engelsk
Tidsskrift BMC Public Health
Vol/bind 17
Tidsskriftsnummer 1
Sider (fra-til) 788
ISSN 1471-2458
DOI
Status Udgivet - 5 okt. 2017

Potential Impact of Diet on Treatment Effect from Anti-TNF Drugs in Inflammatory Bowel Disease

Andersen, V., Hansen, A. K. & Heitmann, B. L. 15 mar. 2017 I : Nutrients. 9, 3

Publikation: Forskning - peer reviewTidsskriftartikel

We wanted to investigate the current knowledge on the impact of diet on anti-TNF response in inflammatory bowel diseases (IBD), to identify dietary factors that warrant further investigations in relation to anti-TNF treatment response, and, finally, to discuss potential strategies for such investigations. PubMed was searched using specified search terms. One small prospective study on diet and anti-TNF treatment in 56 patients with CD found similar remission rates after 56 weeks among 32 patients with good compliance that received concomitant enteral nutrition and 24 with poor compliance that had no dietary restrictions (78% versus 67%, p = 0.51). A meta-analysis of 295 patients found higher odds of achieving clinical remission and remaining in clinical remission among patients on combination therapy with specialised enteral nutrition and Infliximab (IFX) compared with IFX monotherapy (OR 2.73; 95% CI: 1.73-4.31, p < 0.01, OR 2.93; 95% CI: 1.66-5.17, p < 0.01, respectively). In conclusion, evidence-based knowledge on impact of diet on anti-TNF treatment response for clinical use is scarce. Here we propose a mechanism by which Western style diet high in meat and low in fibre may promote colonic inflammation and potentially impact treatment response to anti-TNF drugs. Further studies using hypothesis-driven and data-driven strategies in prospective observational, animal and interventional studies are warranted.

Originalsprog Engelsk
Tidsskrift Nutrients
Vol/bind 9
Tidsskriftsnummer 3
ISSN 2072-6643
DOI
Status Udgivet - 15 mar. 2017

Prenatal low vitamin D may have consequences for bone health. By means of a nationwide mandatory vitamin D fortification programme, we examined the risk of fractures among 10-18-year-old children from proximate birth cohorts born around the date of the termination of the programme. For all subjects born in Denmark during 1983-1988, civil registration numbers were linked to the Danish National Patient Registry for incident and recurrent fractures occurring at ages 10-18 years. Multiplicative Poisson models were used to examine the association between birth cohort and fracture rates. The variation in fracture rates across birth cohorts was analysed by fitting an age-cohort model to the data. We addressed the potential modification of the effect of vitamin D availability by season of birth. The risk of fractures was increased among both girls and boys who were born before the vitamin D fortification terminated in 1985 (rate ratio (RR) exposed v. non-exposed girls: 1·15 (95 % CI 1·11, 1·20); RR exposed v. non-exposed boys: 1·11 (95 % CI 1·07, 1·14). However, these associations no longer persisted after including the period effects. There was no interaction between season of birth and vitamin D availability in relation to fracture risk. The study did not provide evidence that prenatal exposure to extra vitamin D from a mandatory fortification programme of 1·25 µg vitamin D/100 g margarine was sufficient to influence the risk of fractures in late childhood, regardless of season of birth. Replication studies are needed.

Originalsprog Engelsk
Tidsskrift The British journal of nutrition
Vol/bind 117
Tidsskriftsnummer 6
Sider (fra-til) 872-881
Antal sider 10
ISSN 0007-1145
DOI
Status Udgivet - mar. 2017

Prognostic factors associated with mortality in patients with septic arthritis: a descriptive cohort study

Andreasen, R. A., Andersen, N. S., Just, S. A., Christensen, R. & Hansen, I. M. J. jan. 2017 I : Scandinavian Journal of Rheumatology. 46, 1, s. 27-32 6 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: To evaluate the 30-day mortality rate of septic arthritis (SA) in adults in Funen, central Denmark, and to explore whether, at the time of SA presentation, risk factors for the 30-day mortality rate could be revealed. Our secondary objective was to describe the microbiological aetiologies, systemic signs of inflammation, and co-morbidity.

METHOD: A descriptive study identifying patients with SA from central Denmark, during the period 2006-2013, by the use of joint fluid culture data retrieved from the electronic database at the Department of Clinical Microbiology, Odense University Hospital. Patients with a positive joint fluid culture were considered eligible and their medical records were examined.

RESULTS: We identified 215 patients with SA, mean age 64.8 years. At presentation, mean C-reactive protein (CRP) was 204 mg/L, mean white blood cell count (WBC) 11.9 × 10(9)/L, and mean body temperature 37.6°C. A total of 101 patients (47%) had a prosthetic joint, 46 (21%) had an inflammatory joint disease, and 24 (11%) had diabetes mellitus (DM). Staphylococcus aureus was the most common pathogen (104 patients, 48.4%). The 30-day mortality rate was 9.3% and the significant risk factor for death was liver disease at time of presentation [odds ratio (OR) 40.40, 95% confidence interval (CI) 5.38-303]. The other factors tested such as age > 65 years, elevated temperature, rheumatoid arthritis (RA), prostheses, and diabetes mellitus (DM) did not reach statistical significance.

CONCLUSIONS: In our sample of patients with SA, we found a 30-day mortality rate in almost one in 10 adults. Among possible explanations, our study indicates that liver disease is a clinically relevant risk factor.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Rheumatology
Vol/bind 46
Tidsskriftsnummer 1
Sider (fra-til) 27-32
Antal sider 6
ISSN 0300-9742
DOI
Status Udgivet - jan. 2017

Prolonged job strain and subsequent risk of cancer in women - a longitudinal study, based on the Danish Nurse Cohort

Vesterlund, G. K., Høeg, B. L., Johansen, C., Heitmann, B. L. & E Bidstrup, P. feb. 2017 I : Acta oncologica (Stockholm, Sweden). 56, 2, s. 301-306 6 s.

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: The role of psychological stress in cancer risk is continuously debated. Stress at work is the most common form of stress and previous studies have shown inconsistent results regarding cancer risk. In this longitudinal study, we examined the association between prolonged job strain across six years and subsequent cancer risk.

METHODS AND MATERIALS: We used data from 6571 cancer-free women from the Danish Nurse Cohort aged 45-70 years at inclusion, and self-reported questionnaires on job strain at baseline in 1993 and again in 1999. Prolonged job strain was defined as high job busyness and speed, and low control in both 1993 and 1999. Information on cancer diagnosis was obtained from the Danish Cancer Registry. Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals for overall cancer as well as subgroups of virus immune-related, hormone-related, digestive and lung cancers according to level of prolonged job strain. The women were followed from 1 January 2000 until cancer diagnosis, emigration, death or 31 December 2013 (mean follow-up 13 years) and models were adjusted for potential confounders. Effect modification was examined according to working nightshifts and full time.

RESULTS: No significant differences in the risk of overall cancer or any of the cancer subgroups were identified in relation to prolonged busyness, speed, influence, or overall job strain. Effect modification by working full time was observed when examining job influence in relation to overall cancer risk, and by working nightshifts when examining job influence in relation to hormone related cancer risk. However, none of the associations were significant in stratified analyses.

CONCLUSION: We found no evidence of an increased risk of any cancer among women with prolonged job strain. Since a large proportion of cancer patients perceive psychological stress as a possible cause of their cancer disease, it is of importance to communicate these findings to the public.

Originalsprog Engelsk
Tidsskrift Acta oncologica (Stockholm, Sweden)
Vol/bind 56
Tidsskriftsnummer 2
Sider (fra-til) 301-306
Antal sider 6
ISSN 0284-186X
DOI
Status Udgivet - feb. 2017

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

Thorlacius, L., Ingram, J. R., Garg, A., Villumsen, B., Esmann, S., Kirby, J. S., Gottlieb, A. B., Merola, J. F., Dellavalle, R., Christensen, R. & Jemec, G. B. E. 20 feb. 2017 I : B M J Open. 7, 2, s. e014733

Publikation: Forskning - peer reviewTidsskriftartikel

INTRODUCTION: Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS.

METHOD AND ANALYSIS: An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation.

ETHICS AND DISSEMINATION: The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well accepted.

Originalsprog Engelsk
Tidsskrift B M J Open
Vol/bind 7
Tidsskriftsnummer 2
Sider (fra-til) e014733
ISSN 2044-6055
DOI
Status Udgivet - 20 feb. 2017

BACKGROUND: Pain is inherent in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (SpA) and traditionally considered to be of nociceptive origin. Emerging data suggest a potential role of augmented central pain mechanisms in subsets of patients, thus, valid instruments that can identify underlying pain mechanisms are needed. The painDETECT questionnaire (PDQ) was originally designed to differentiate between pain phenotypes. The objectives were to evaluate the psychometric properties of the PDQ in patients with inflammatory arthritis by applying Rasch analysis and to explore the reliability of pain classification by test-retest.

METHODS: For the Rasch analysis 900 questionnaires from patients with RA, PsA and SpA (300 per diagnosis) were extracted from 'the DANBIO painDETECT study'. The analysis was directed at the seven items assessing somatosensory symptoms and included: 1) the performance of the six-category Likert scale; 2) whether a unidimensional construct was defined; 3) the reliability and precision of estimates. Another group of 30 patients diagnosed with RA, PsA or SpA participated in a test-retest study. Intraclass Correlation Coefficients (ICC) and classification consistency were calculated.

RESULTS: The Rasch analysis revealed: (1) Acceptable psychometric rating scale properties; the frequency distribution peaked in category 0 except for item 5, threshold calibration >10 observations per category, no disorder in the category measures for all items, scale category outfit Mnsq <2.0, small distances (<1.4 logits) between thresholds for category 1, 2 and 3 for all items. (2) The principal component analysis supported unidimensionality; the standardized residuals showed that 53.7% of total variance was explained by the measure and the magnitude of first contrast had an eigenvalue of 1.5, no misfitting items, clinical insignificant different item hierarchies across diagnoses (DIF < 0.5 logits). (3) A targeted item-person map, person and item separation indices of 1.88(reliability = 0.78), and 13.04 (reliability = 0.99). The test-retest revealed: ICC: RA 0.86(0.56-0.96), PsA 0.96(0.74-0.99), SpA 0.93(0.76-98), overall 0.94(0.84-0.98). Classification consistency was: RA 70%, PsA 80%, SpA 90%, overall 80%.

CONCLUSION: The results support that the PDQ can be used as a classification instrument and assist identification of underlying pain-mechanisms in patients suffering from inflammatory arthritis.

Originalsprog Engelsk
Tidsskrift Health and Quality of Life Outcomes
Vol/bind 15
Tidsskriftsnummer 1
Sider (fra-til) 110
ISSN 1477-7525
DOI
Status Udgivet - 22 maj 2017

Relapse and Mortality Risk of Stage I Testicular Cancer

Florvall, C., Frederiksen, P., Lauritsen, J., Bandak, M., Kier, M. G. G., Mortensen, M. S., Kreiberg, M. & Daugaard, G. 2017 I : The Insurance Record. 47, 2, s. 114-124 11 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: - To assess the medical insurance risk for patients with stage I testicular cancer (TC), by calculating the overall mortality risk with and without relapse, and compare it to men from the Danish population.

BACKGROUND: - Testicular cancer is the most common malignancy in young males. Outcomes of a Danish cohort of 3366 patients with stage I TC (1366 non-seminomas (NSTC) and 2000 Seminomas (STC)), were analyzed.

METHOD: - The data were analyzed by the "illness-death" model. For the analysis of the transitions between diagnosis, relapse and death we adopted a parametric approach, where the relationship between the intensities and the effect of covariates were specified by Poisson regression models for NSTC and STC individually.

RESULTS: - In the NSTC group, 422 patients relapsed. Six relapses (1.4%) occurred after 5 years of follow-up. In the STC group, 389 relapsed. The relapse rate after 5 years was 4.1%. The overall mortality analyses showed that the standardized mortality ratio (SMR) for men with NSTC without relapse, was slightly lower than in the matched general population of Danish men (SMR = 0.9). In STC patients without relapse, SMR was 0.80. Relapse raised the overall mortality by a factor 2.0 for NSTC and 1.5 for STC.

CONCLUSIONS: - The fact that few relapses occur 5 years after diagnosis is an important finding for risk assessment in life insurance. It makes it possible to insure men diagnosed with stage I TC, who have not experienced relapse 5 years after diagnosis, on normal terms.

Originalsprog Engelsk
Tidsskrift The Insurance Record
Vol/bind 47
Tidsskriftsnummer 2
Sider (fra-til) 114-124
Antal sider 11
ISSN 0743-6661
DOI
Status Udgivet - 2017

Relationship between pickiness and subsequent development in body mass index and diet intake in obesity prone normal weight preschool children

Rohde, J. F., Händel, M. N., Stougaard, M., Olsen, N. J., Trærup, M., Mortensen, E. L. & Heitmann, B. L. 2017 I : P L o S One. 12, 3, s. e0172772

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Most children have periods in their life where they reject familiar as well as non-familiar food items and this is often referred to as pickiness. The consequences of pickiness may be malnutrition and, if prolonged, potentially lower body weight. However, studies investigating the consequence of pickiness on subsequent changes in diet intake and weight are limited.

OBJECTIVES: To examine whether pickiness influences body mass index as well as diet intake over subsequent 15 months among obesity prone normal weight children aged 2-6 years.

METHODS: Data was obtained from the "Healthy Start" intervention study which included 271 children aged 2-6 years susceptible to overweight later in life. Information on pickiness was obtained from a parental questionnaire. Dietary habits were collected by 4-day dietary records filled in by the parents and height and weight were measured by trained health professionals and both measured twice over a 15 month period. Linear regression models were performed to assess the influence of pickiness on body mass index and diet with adjustments for possible confounders.

RESULTS: No differences in mean BMI Z-score were seen between picky/non-picky (P = 0.68) and little picky/non-picky (P = 0.68) children at 15 month follow-up. Picky children had a lower intake of protein (P = 0.01) than non-picky children despite no differences in total energy intake (P = 0.74), or in the other macronutrients, or the intake of fruit and vegetables, though children being a little picky had a lower intake of starch compared to non-picky children (P = 0.05). Results were essentially similar before and after adjustment for key covariates.

CONCLUSION: Our study showed that BMI Z-score after 15 months follow-up was similar for picky and non-picky children. Picky children seemed to develop a lower protein intake despite similar total energy intake and diet composition.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 12
Tidsskriftsnummer 3
Sider (fra-til) e0172772
ISSN 1932-6203
DOI
Status Udgivet - 2017

OBJECTIVE: To explore effects of weight loss and maintenance on serum cartilage biomarkers denaturation neoepitope for Collagen2 (Coll2-1) and Fibulin3 fragment (Fib3-2), as well as correlations between Coll2-1 and Fib3-2 and symptomatic improvement, in a knee osteoarthritis (KOA) population.

DESIGN: 192 obese KOA patients followed a 16 week weight loss intervention and 52 weeks weight maintenance (ClinicalTrials.gov identifier: NCT00655941). Assessments were at 0, 8, 16 and 68 weeks. Serum Coll2-1 and Fib3-2 were determined with ELISA, and symptoms by the Knee Osteoarthritis Outcome Score (KOOS) questionnaire. Changes from week 0 and association between changes from baseline in body weight and Coll2-1, Fib3-2, and the 5 KOOS domains were assessed at all time points.

RESULTS: Coll2-1 changes from baseline showed a decrease at week 8 (P = 0.0002), no change at week 16 (P = 0.49), and an increase at week 68 (P = 0.036). Fib3-2 showed an increase from baseline at week 8 (P = 0.0015) and 16 (P < 0.0001), but none at week 68 (P = 0.23). No statistically significant correlations were found between changes in body weight and Coll2-1 and Fib3-2 at any time point (r < 0.05; P > 0.49). At all time-points there were significant positive correlations between changes from baseline in Coll2-1 and in KOOSSports/Recreation (week 8, 16, 68: r = 0.17; P = 0.03; r = 0.16; P = 0.04; and r = 0.17; P = 0.04, respectively).

CONCLUSION: The clinical improvement after a substantial weight loss and weight maintenance in KOA patients was not associated with decrease in markers of cartilage breakdown Coll2-1 or Fib3-2, even with indications of a slightly negative effect.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and Cartilage
ISSN 1063-4584
DOI
Status Udgivet - 6 jul. 2017

Reliability of an Omeract Semiquantitative Scoring System and Imaging Atlas for the Assessment of Cartilage in Hand Osteoarthritis

Mathiessen, A., Hammer, H. B., Terslev, L., Bruyn, G. A. W., D'Agostino, M. A., Filippucci, E., Haugen, I. K., Kortekaas, . M., Mandl, P., Moller, I., Naredo, E., Wittoek, . R., Iagnocco, A. & Ellegaard, K. 2017 I : Arthritis & Rheumatology. 69, S10, 265

Publikation: Forskning - peer reviewKonferenceabstrakt i tidsskrift

Originalsprog Engelsk
Artikelnummer 265
Tidsskrift Arthritis & Rheumatology
Vol/bind 69
Tidsskriftsnummer S10
ISSN 1537-2960
Status Udgivet - 2017

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