Comparison between continued inpatient treatment versus day patient treatment after short inpatient care in early onset anorexia nervosa (COTIDEA trial): a study protocol for a non-inferiority randomised controlled trial.

BACKGROUND: In children with early-onset anorexia nervosa (first symptoms before 13 years old, EO-AN), experts recommend initial outpatient treatment but in-patient treatment (IP) is frequently indicated due to acute medical instability or for those who have not improved with outpatient treatment. This IP can target either a partial weight restauration or a total weight normalization (return to the previous BMI growth trajectory). There are no evidence in the literature on which is the better therapeutic option in EOAN. But as long length of stay induce social isolation, with elevated costs, we wonder if a stepped-care model of daypatient treatment (DP) after short IP stabilisation may be a treatment option as effective as full-time IP to target weight normalization. We designed a two-arm randomised controlled trial testing the non-inferiority of a stepped-care model of DP after short IP stabilisation versus full-time IP. METHODS: Eighty-eight children aged 8 to 13 years suffering from EOAN with initial severe undernutrition will be randomly allocated to either IP treatment as usual or a stepped care DP model both targeting weight normalization. Assessments will be conducted at inclusion, somatic stabilization, weight normalization, 6 months and 12 months post randomisation. The primary outcome will be BMI at 12 months post-randomisation. Secondaries outcomes will included clinical (tanner stage), biological (prealbumin, leptin, total ghrelin and IGF1) and radiological (bone mineralization and maturation) outcomes, eating symptomatology and psychiatric assessments, motivation to change, treatment acceptability and quality of life assessments, cost-utility and cost-effectiveness analyses. DISCUSSION: COTIDEA will provide rigorous evaluation of treatment alternative to full-time inpatient treatment to allow a reduction of social iatrogenic link to hospital length of stay and associated costs. TRIAL REGISTRATION: Trial is registered on ClinicalTrials.gov (NCT04479683).

[Well-being in adulthood of patients with chronic conditions in childhood: The GEDEPAC-2 questionnaire]. / Bien-être à l'âge adulte des enfants atteints de maladies chroniques : le questionnaire GEDEPAC-2.

BACKGROUND: In France, chronic diseases affect 3 million children. In children with chronic conditions, long-term somatic outcome has been well described, but little is known about the psychosocial aspects of well-being. METHODS: Our aim was to build a self-administered questionnaire of global well-being in adults who had a chronic disease since or during childhood using a multidimensional and nonspecific approach. The questionnaire was constructed by a multidisciplinary group (epidemiologists, clinicians, sociologist, statistician). Items were built in compliance with reference data from the French general population (national surveys, free access) to allow comparative analysis adjusted for age and sex (and eventually other confounding factors) by indirect standardization (qualitative variables) or Z-scores (quantitative variables). RESULTS: The GEDEPAC-2 includes 108 items exploring 11 domains: education, employment, housing, material security, social links, civic engagement, leisure, environment, physical health/risky behavior, health-related quality of life and sex life. Factual questions and satisfaction scales jointly explore social well-being. Quality of life is analyzed in terms of physical quality of life, mental quality of life, fatigue and burden of treatment by 3 questionnaires validated in French (SF-12; MFI-20; Burden of Treatment Questionnaire). Experience of transition from pediatric to adult healthcare is described in 21 items. Paper and electronic versions were developed. CONCLUSION: Built in a multidimensional approach to well-being and in line with the available reference data, GEDEPAC-2 will facilitate the implementation of future studies on impact in adulthood of chronic disease in childhood.

[Comparison of refraction with or without cycloplegia using Retinomax® or Plusoptix® devices]. / Comparaison de la réfraction avec ou sans cycloplégie au Retinomax® vs Plusoptix®.

PURPOSE: To evaluate the refraction in children measured with Plusoptix® without cycloplegia vs. Retinomax® apparatus with cycloplegia. PATIENTS AND METHODS: Measure of refraction with Plusoptix® in children>1year old referred for systematic vision screening, then measurement after cycloplegia with cyclopentolate by the Retinomax® device. RESULTS: Thirty-three children were included, i.e. 66eyes. Mean age was 40.7months (minimum 12; maximum 114). The Spearman correlation coefficient for the spherical equivalent was 0.52 (Plusoptix® vs. Retinomax® comparison; P<0.0001=moderate correlation). The Spearman correlation coefficient was 0.73 for astigmatism (Plusoptix® vs. Retinomax® comparison; P<0.0001=strong correlation). The Plusoptix® sensitivity for measurement of refraction was 57%, 43% and 43% respectively for spherical equivalent, sphere and astigmatism. DISCUSSION AND CONCLUSION: The correlation of astigmatism values is strong, whereas the correlation of sphere values is moderate. Plusoptix® seems to be unable to measure the exact refraction, because there is too large a dispersion of refraction measurements with Plusoptix®, compared to the exact refraction measured with the Retinomax®. Moreover, the sensitivity of Plusoptix® is low. Cycloplegic refraction remains indispensable in children.

Methodology used in comparative studies assessing programmes of transition from paediatrics to adult care programmes: a systematic review.

OBJECTIVE: To explore the methodologies employed in studies assessing transition of care interventions, with the aim of defining goals for the improvement of future studies. DESIGN: Systematic review of comparative studies assessing transition to adult care interventions for young people with chronic conditions. DATA SOURCES: MEDLINE, EMBASE, ClinicalTrial.gov. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: 2 reviewers screened comparative studies with experimental and quasi-experimental designs, published or registered before July 2015. Eligible studies evaluate transition interventions at least in part after transfer to adult care of young people with chronic conditions with at least one outcome assessed quantitatively. RESULTS: 39 studies were reviewed, 26/39 (67%) published their final results and 13/39 (33%) were in progress. In 9 studies (9/39, 23%) comparisons were made between preintervention and postintervention in a single group. Randomised control groups were used in 9/39 (23%) studies. 2 (2/39, 5%) reported blinding strategies. Use of validated questionnaires was reported in 28% (11/39) of studies. In terms of reporting in published studies 15/26 (58%) did not report age at transfer, and 6/26 (23%) did not report the time of collection of each outcome. CONCLUSIONS: Few evaluative studies exist and their level of methodological quality is variable. The complexity of interventions, multiplicity of outcomes, difficulty of blinding and the small groups of patients have consequences on concluding on the effectiveness of interventions. The evaluation of the transition interventions requires an appropriate and common methodology which will provide access to a better level of evidence. We identified areas for improvement in terms of randomisation, recruitment and external validity, blinding, measurement validity, standardised assessment and reporting. Improvements will increase our capacity to determine effective interventions for transition care.

Long-term impact of childhood-onset type 1 diabetes on social life, quality of life and sexuality.

AIM: This study describes the socio-professional outcomes, health-related quality of life (HRQOL) and sexuality of adults with childhood-onset type 1 diabetes (T1D). METHODS: The study participants (n=388), recruited from a nationwide registry (age: 28.5 ± 3.1 years; T1D duration: 17.0 ± 2.7 years), completed a questionnaire (198 items); the results were compared with the French general population using standardized incidence ratios (SIRs) and Z scores matched for age, gender and period with/without education levels and patterns of family life. Linear regression models also investigated correlates of SF-36 Physical (PCS) and Mental Composite Scores (MCS). RESULTS: Compared with the French general population, education levels of people with T1D were similar, with 68.6% having at least a high-school diploma or higher (SIR: 1.06, 95% CI: 0.93; 1.20), as were also their patterns of family life. Unemployment was higher in T1D women (15.3%, SIR: 1.50, 1.00; 2.05), but not in T1D men (8.6%, SIR: 0.96, 0.51; 1.57). Social discrimination was more common (SIR: 5.64, 4.64; 6.62), and frequency of daily alcohol consumption was higher (SIR: men, 3.34, 2.38; 4.54; women, 6.53, 4.57; 12.99). PCS and MCS were decreased moderately (mean ± SD: 52.0 ± 7.5; mean Z score: -0.2, 95% CI: -0.3; -0.1) and substantially (mean ± SD: 42.1 ± 12.4; mean Z score: -0.7, -0.8; -0.6), respectively. Fatigue and abandoning sports were predictive of a lower HRQOL. Both men and women were more frequently dissatisfied with their sex life. Prevalence of sexual problems was higher in women (SIR for: dysorgasmia, 1.91, 1.21-2.88; decreased/loss of desire: 2.11, 1.35-3.08), but similar in men. Participants with T1D-related complications had preserved social outcomes, but altered HRQOL. CONCLUSION: Young adults with T1D have satisfactory social participation. However, their higher alcohol consumption, lower MCS and frequent dissatisfaction with sexuality suggest a heavy impact of the disease on morale, especially in women. Improving the everyday well-being of these young adults represents a key challenge for diabetes healthcare.

HLA-associated genetic resistance and susceptibility to type I diabetes in French North Africans and French natives.

The distribution of human leukocyte antigen (HLA)-DRB1-DQA1-DQB1 haplotypes was analyzed separately in two distinct French ethnic groups with type I diabetes (T1D), i.e. French North African migrants (n= 64, mean age at diagnosis = 8.25 years) and ancient French natives (n= 60, mean age at diagnosis = 7.42 years). HLA associations were determined by calculating odds ratios (ORs) between patients and two ethnic-matched control populations. Results show highly similar ORs for the conservative DRB1*0301-DQA1*0501-DQB1*0201 haplotype of susceptibility (OR: 3.22 and 3.93 in migrants and natives, respectively) and the DRB1*1501-DQA1*0102-DQB1*0602 haplotype of resistance (OR: 0.05 and 0.03, respectively). In contrast, among the more variable DRB1*04-DQB1*0302 haplotypes of susceptibility, the DRB1*0402 (OR: 3.10 and 32.84) and 0405 (OR: 5.90 and 16.25, respectively) were associated with T1D in migrants and natives, whereas an increase of DRB1*0401, a rare allele in migrants, was significant in natives only. Also, among the DRB1*11-DQA1*0505-DQB1*0301 haplotypes of resistance, the OR observed for DRB1*1104-DQA1*0505-DQB1*0301, common in migrants, was lower (OR: 0.08) than for DRB1*1101-DQA1*0505-DQB1*0301 (OR: 0.32), common in natives. How DRB1*11 subtypes might affect differently the risk conferred by DQA1*0505-DQB1*0301 will be discussed.