INTRODUCTION: Lumbar spinal stenosis is a common cause of low back and leg pain in the elderly and affects both physical activity and quality of life. First-line treatments are non-surgical options but if unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery compared with non-surgical treatment, and the optimal time for surgery is not explicit. This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical management in patients with lumbar spinal stenosis and identify prognostic factors for outcome in the context of current clinical practice.

MATERIALS AND ANALYSIS: Prospectively registered data on treatment, outcome and patient characteristics are collected from nationwide registers on health and social issues, a clinical registry of people with chronic back pain and hospital medical records. Primary outcome is change in physical function measured by the Zurich Claudication Questionnaire. Secondary outcomes are changes in symptom severity, pain-related function, health-related quality of life and general self-efficacy. Outcomes are assessed at baseline and 6 and 12 months. Outcomes at 12 months will be compared for patients who undergo surgery for lumbar spinal stenosis and patients managed non-surgically, using different analytical approaches. Prespecified prognostic factors of interest at baseline include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pretreatment function, self-rated health, income, general self-efficacy and MRI-graded severity of central stenosis.

ETHICS AND DISSEMINATION: The study has been evaluated by the Regional Committees on Health Research for Southern Denmark (S-20172000-200) and notified to the Danish Data Protection Agency (18/22336). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences according to the Strengthening the Reporting of Observational Studies in Epidemiology and Prognosis Research Strategy statements. Potential sources of bias will be addressed using Risk of Bias in Non-randomised Studies of Interventions.

TRIAL REGISTRATION NUMBER: NCT03548441; Pre-results.

Studies have suggested that vitamin D status at birth may be associated with a range of neonatal outcomes. The aim of this study was to assess the association between neonatal 25-hydroxyvitamin D3 (25(OH)D3) concentration and gestational age, birth weight, Ponderal Index and size for gestational age. Neonatal capillary blood stored as dried blood spots was used to assess 25(OH)D3 concentrations among 2686 subjects selected from a random population sub-sample of individuals, born in Denmark from 1 May 1981 to 31 December 2002. There was an inverse association between 25(OH)D3 concentration and gestational age at birth of -0·006 (95 % CI -0·009, -0·003, P<0·001) weeks of gestation per 1 nmol/l increase in 25(OH)D3 concentration. An inverted U-shaped association between 25(OH)D3 and birth weight and Ponderal Index (P=0·04) was found, but no association with size for gestational age was shown. This study suggests that neonatal 25(OH)D3 concentration is associated with anthropometric measures at birth known to be correlated with many subsequent health outcomes such as obesity and type 2 diabetes.

In the original version of this article the first name of the co-author was incorrectly spelled as "Khaled A. Alnaqbi". The correct spelling should have been "Khalid A. Alnaqbi". This is now presented correctly in this article.

BACKGROUND: Healthy dietary and physical activity behaviours are established early in life where children learn by observing their parents. Therefore, parents can act as role models and influence their children toward a healthier lifestyle. Besides a strong association between parental and child health behaviours, parents also influence their children's health behaviours through socio-cognitive processes, where perceived self-efficacy is the central component. The objective was to examine if parental self-efficacy among Swedish mothers was associated with their four-year-old children's dietary and physical activity behaviours.

METHODS: This cross-sectional study was based on information from control participants that took part in the Swedish primary prevention trial of childhood obesity (PRIMROSE) (n = 420 mother-child pairs). Linear regression models were used to examine the associations between parental self-efficacy (Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviours in Children Scale) and children's dietary intake (parent reported) and levels of physical activity (accelerometer) with adjustments for potential confounders.

RESULTS: Mothers' efficacy beliefs in promoting healthy dietary or physical activity behaviours in their children were associated with a slightly higher consumption of fruit and vegetables among their children (β: 0.03 [95%CI: 0.01; 0.04] P < 0.001) and slightly higher levels of moderate-to-vigorous activity (β: 0.43 [95%CI: 0.05; 0.81] P = 0.03). Mothers' belief in their ability to limit unhealthy dietary and physical activity behaviours was inversely associated with children's intake of unhealthy snacks (β: -0.06 [95%CI: -0.10; -0.02] P < 0.01).

CONCLUSION: Our cross-sectional study suggests weak positive correlations between maternal self-efficacy and healthy dietary and physical activity behaviours, and weak inverse associations between maternal self-efficacy and unhealthy dietary and physical activity behaviours among their children.

BACKGROUND: Early cartilage changes in knee osteoarthritis (OA) can be assessed by both intravenous (i.v.) and intra-articular (i.a.) delayed gadolinium-enhanced MRI of cartilage (dGEMRIC).

PURPOSE: To examine the relationship between i.a. dGEMRIC and delayed gadolinium-enhanced MRI of menisci (dGEMRIM), and to investigate if the approach can be used to assess the morphological degeneration of menisci in obese patients with knee OA.

STUDY TYPE: Cross-sectional.

POPULATION: Eighty-five obese patients with knee OA.

FIELD STRENGTH/SEQUENCES: 1.5T. Inversion recovery sequence with four inversion times.

ASSESSMENT: T1 relaxation times were calculated for posterior weight-bearing femoral cartilage and the posterior horns of the menisci. Meniscus degeneration sum score (0-2) was assessed as increased signal/no signal (1/0) and tear/no tear (1/0).

STATISTICAL TESTS: T1 relaxation times were compared using Student's t-test. Comparison of cartilage and meniscus T1 relaxation times was done by regression analysis. Analysis of variance (ANOVA) was used for comparison of meniscal T1 relaxation times among the three summed morphological scores (0-2). Statistical analyses were performed with a level of significance at 0.05.

RESULTS: For lateral menisci, morphology sum scores of 0, 1, and 2 were found in 13, 58, and 14 patients and for medial menisci in 2, 30, and 30 patients, respectively. Mean T1 relaxation times were 441 msec, 480 msec, and 497 msec for cartilage, lateral menisci, and medial menisci, respectively. T1 relaxation times for the menisci were similar (P = 0.53), and a weak correlation was found between dGEMRIC and dGEMRIM in the lateral compartments (R = 0.26). Comparing dGEMRIM between different morphology sum scores showed no differences (P > 0.4).

DATA CONCLUSION: I.a. dGEMRIM showed no correlation between the degree of meniscal degeneration and meniscus T1 relaxation times. I.a. dGEMRIM do not seem to deliver useful information about meniscus degeneration to be suitable for clinical applications, but i.a. dGEMRIC may still be considered an alternative contrast-saving method for cartilage.

LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 3 J. Magn. Reson. Imaging 2018;48:1700-1706.

Objective: Adaptive designs can enable highly sophisticated and efficient early phase trials, but the clinical inference from these trials is surrounded by complexity, and currently there is a paucity but steadily increasing amount of use of these designs in all fields of medicine. We aim to review early phase trials in RA to discover those that have used adaptive designs and benchmark trial characteristics.

Methods: From an OVID search for journal articles reporting the results of early phase trials in rheumatology, 35 studies were found, with 9 subsequently excluded; 11 were added from manual searches and 19 from searching the references. Study characteristics were extracted from the 56 papers (describing 62 trials), including the number of arms, number of patients, the primary outcome and when it was measured.

Result: One early phase trial using an adaptive design was found. The benchmark early phase trial in RA is a phase II double-blinded randomized trial, with four arms (one control and three intervention), each with 34 patients, and ACR20 measured at 16 weeks as the primary outcome.

Conclusion: The one adaptive design reviewed here, and a simulation study found in the search, both indicate that adaptive designs can be applied to early phase trials in RA. We have described the benchmark, which the efficiency of early phase trials using an adaptive design needs to exceed. These efficient designs could drive down numbers required, time for data collection and thus cost. Changes have been suggested, but more needs to be done.