Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial.

OBJECTIVE: To assess the cost-effectiveness of an internet-based, nurse-led vascular risk factor management programme in addition to usual care compared with usual care alone in patients with a clinical manifestation of a vascular disease. DESIGN: Cost-effectiveness analysis alongside a randomised controlled trial (the Internet-based vascular Risk factor Intervention and Self-management (IRIS) study). SETTING: Multicentre trial in a secondary and tertiary healthcare setting. PARTICIPANTS: 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with ≥2 treatable vascular risk factors not at goal. INTERVENTION: The intervention consisted of a personalised website with an overview and actual status of patients' vascular risk factors, and mail communication with a nurse practitioner via the website for 12 months. The intervention combined self-management support, monitoring of disease control and pharmacotherapy. MAIN OUTCOME MEASURES: Societal costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. RESULTS: Patients experienced equal health benefits, that is, 0.86 vs 0.85 QALY (intervention vs usual care) at 1 year. Adjusting for baseline differences, the incremental QALY difference was -0.014 (95% CI -0.034 to 0.007). The intervention was associated with lower total costs (€4859 vs €5078, difference €219, 95% CI -€2301 to €1825). The probability that the intervention is cost-effective at a threshold value of €20,000/QALY, is 65%. At mean annual cost of €220 per patient, the intervention is relatively cheap. CONCLUSIONS: An internet-based, nurse-led intervention in addition to usual care to improve vascular risk factors in patients with a clinical manifestation of a vascular disease does not result in a QALY gain at 1 year, but has a small effect on vascular risk factors and is associated with lower costs. TRIAL REGISTRATION NUMBER: NCT00785031.

Internet based vascular risk factor management for patients with clinically manifest vascular disease: randomised controlled trial.

OBJECTIVE: To investigate whether an internet based, nurse led vascular risk factor management programme promoting self management on top of usual care is more effective than usual care alone in reducing vascular risk factors in patients with clinically manifest vascular disease. DESIGN: Prospective randomised controlled trial. SETTING: Multicentre trial in secondary and tertiary healthcare setting. PARTICIPANTS: 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with at least two treatable risk factors not at goal. INTERVENTION: Personalised website with an overview and actual status of patients' risk factors and mail communication via the website with a nurse practitioner for 12 months; the intervention combined self management support, monitoring of disease control, and drug treatment. MAIN OUTCOME MEASURES: The primary endpoint was the relative change in Framingham heart risk score after 1 year. Secondary endpoints were absolute changes in the levels of risk factors and the differences between groups in the change in proportion of patients reaching treatment goals for each risk factor. RESULTS: Participants' mean age was 59.9 (SD 8.4) years, and most patients (n=246; 75%) were male. After 1 year, the relative change in Framingham heart risk score of the intervention group compared with the usual care group was -14% (95% confidence interval -25% to -2%). At baseline, the Framingham heart risk score was higher in the intervention group than in the usual care group (16.1 (SD 10.6) v 14.0 (10.5)), so the outcome was adjusted for the separate variables of the Framingham heart risk score and for the baseline Framingham heart risk score. This produced a relative change of -12% (-22% to -3%) in Framingham heart risk score for the intervention group compared with the usual care group adjusted for the separate variables of the score and -8% (-18% to 2%) adjusted for the baseline score. Of the individual risk factors, a difference between groups was observed in low density lipoprotein cholesterol (-0.3, -0.5 to -0.1, mmol/L) and smoking (-7.7%, -14.9% to -0.4%). Some other risk factors tended to improve (body mass index, triglycerides, systolic blood pressure, renal function) or tended to worsen (glucose concentration, albuminuria). CONCLUSION: An internet based, nurse led treatment programme on top of usual care for vascular risk factors had a small effect on lowering vascular risk and on lowering of some vascular risk factors in patients with vascular disease. TRIAL REGISTRATION: Clinical trials NCT00785031.

Validation of the Peritraumatic Dissociative Experiences Questionnaire and Peritraumatic Distress Inventory in school-aged victims of road traffic accidents.

BACKGROUND: Although the reliable and valid Peritraumatic Distress Inventory (PDI-C) and Peritraumatic Dissociative Experiences Questionnaire (PDEQ) are useful for identifying adults at risk of developing acute and chronic posttraumatic stress disorder (PTSD), they have not been validated in school-aged children and their predictive values remain unknown in this population. This study aims to assess the psychometric properties of the children versions of these two measures (PDI-C and PDEQ-C) in a sample of French-speaking school-children. METHODS: One-hundred and thirty-three consecutive victims of road traffic accidents, aged 8-15 years, were recruited into this longitudinal study via the emergency room. The peritraumatic reactions were assessed at baseline and PTSD symptoms were assessed 1 month later. RESULTS: Cronbach's alpha coefficients were 0.8 and 0.77 for the PDI-C and PDEQ-C, respectively. The 1-month test-retest correlation coefficient (n=33) was 0.77 for both measures. The PDI-C demonstrated a two-factor structure while the PDEQ-C displayed a one-factor structure. As with adults, the two measures were intercorrelated (r=0.52) and correlated with subsequent PTSD symptoms and diagnosis (r=0.21-0.56; P<0.05). CONCLUSIONS: The children versions of the PDI and PDEQ are reliable and valid in children.

Expert consensus on gestational diabetes mellitus. Methods and organization.

Reminder of the aim of clinical practice recommendations (CPR). The ever more rapid development of new techniques and the diffusion of large amounts of information in the medical literature make it difficult for clinicians to assimilate and synthesize everything, giving rise to major variations in practices that are sometimes inappropriate or even unnecessary. This situation has led several countries to establish recommendations for treatment, diagnosis, prevention methods and disease care. These recommendations aim to help clinicians in decision-making by offering a synthesis with a certain level of scientific proof or professional consensus.

Endocrine disorders in children with Prader-Willi syndrome--data from 142 children of the French database.

AIM: The first results from the French National Prader-Willi pediatric database in a cohort of 142 children aged 0.2-18.8 years are reported. This database gathers information about the endocrine dysfunctions traditionally described in Prader-Willi patients. METHODS: Questionnaires were filled in by the patients' practitioners. The coordination team of the reference center performed the statistical analysis. RESULTS: Median BMI Z-score was +1.3 for a median age of 7.1 years, and 40% of the population were overweight or obese (International Obesity Task Force 2000 criteria). Growth hormone deficiency was present in 80% of patients and 86.7% were treated, with a height gain of +1 SD and a BMI reduction of -0.8 Z-score achieved in the first year of treatment. Hypogonadism was present in 49% of patients, and hypothyroidism in 24.4%. Glucose intolerance was found in 4% of patients, but no diabetes mellitus was detected in the 74 patients explored. CONCLUSION: Our report gives an overview of endocrine dysfunctions recorded in a large registry database of French children and adolescents with Prader-Willi syndrome. The database, which now encompasses six southern regions of France, will be further extended to the whole country and to adult patients.

Prevention of overweight in preschool children: results of kindergarten-based interventions.

OBJECTIVE: Given the increasing prevalence of pediatric obesity, we evaluated two kindergarten-based strategies for reducing overweight in preschool children in the Haute-Garonne Department in France. METHODS: Kindergartens (n=79) were randomly assigned to one of the two strategies and followed for 2 years. In the first group (Epidémiologie et prévention de l'obésité infantile, EPIPOI-1), parents and teachers received basic information on overweight and health, and children underwent screening to identify those with overweight (body mass index (BMI) > or = 90th percentile) or at risk for overweight (BMI between 75 and 90th percentile), who were then followed up by their physicians. EPIPOI-2 children, in addition, received kindergarten-based education to promote healthy practices related to nutrition, physical activity and sedentary behaviors. Data on control children from non-intervention kindergartens (n=40) were retrieved from medical records at the Division of School Health. RESULTS: At baseline, groups differed significantly on age and school area (underprivileged/not). Owing to a significant interaction between school area and group, analyses were stratified by school area. At baseline, groups did not differ on overweight prevalence and BMI z-scores for any school area. After intervention, prevalence of overweight, BMI z-score and change in BMI z-score were significantly lower in intervention groups compared with controls in underprivileged areas. Using multilevel analysis adjusted for potential confounders, a significant effect on overweight prevalence at the end of the study was noted for EPIPOI-1 in underprivileged areas only (odds ratio and 95% confidence interval: 0.18 (0.07-0.51). In non-underprivileged areas, the gain in BMI z-score was lower in EPIPOI-2 group compared with control and EPIPOI-1. CONCLUSION: Our results suggest that simple measures involving increasing awareness on overweight and health, and periodic monitoring of weight and height with follow-up care when indicated, could be useful to reduce overweight in young children from underprivileged areas. A reinforced strategy with an education component, in addition, may be indicated in children in non-underprivileged areas.

Triadic nonverbal communication in mother-infant consultations: Two contrasted cases.

The aim of the present case study was to present and discuss the analysis of triadic nonverbal communication between mother, infant, and therapist in two early consultations as an indicator of the therapeutic alliance. The analysis explored nonverbal triadic interactions (body positions and facial orientations of the mother, infant, and therapist, and expressive behaviors of the infant) and triadic affective sharing (via a microanalytic interview of the therapist). The quality of the therapeutic alliance and clinical outcome for each case are described. The description of the two cases illustrates the importance of the progressive development of nonverbal "engagement" by the three people (triadic alliance) and of moments with triadic emotional sharing. The contribution of the therapist appears to be crucial, in particular via his or her body and affective engagement with the infant. The triadic alliance appears to be both an indicator of the therapeutic alliance and an element that can foster it.

[Factors associated with early sexual initiation in girls: French data from the international survey Health Behaviour in School-aged Children (HBSC)/WHO]. / Facteurs associés à une initiation sexuelle précoce chez les filles: données françaises de l'enquête internationale Health Behaviour in School-aged Children (HBSC)/OMS.

OBJECTIVE: Inspite of unquestionable progress, the protection of girls at first sexual intercourse is still not perfect. The main risks are well known (sexually transmitted infections [STIs], unwanted pregnancies, psychological consequences) and seem to be higher in the case of early sexual initiation. The aim of this epidemiological study is to analyse factors associated with early heterosexual intercourse (age 15 or before) among girls, considered as risk factors for pregnancies and STIs. POPULATION AND METHODS: Our data come from the 2002 international survey Health Behaviour in School-aged Children (HBSC)/WHO. The questionnaire is completed anonymously in class and measures health, health behaviours and their contexts among 11-, 13- and 15-year-old students. Only the 15 year-olds are asked about their sexual behaviour. In France, 1264 15-year-old (plus or minus six months) girls have answered the survey. RESULTS: Two hundred and twenty-four girls (17,7 %) state they have already had sexual intercourse. Among these, 88,4 % say that condoms and/or pills were used at last sexual intercourse. Multivariate analysis (n=1159) show that seven variables are significantly and independently linked to a higher frequency of early sexual intercourse: single-parent or reconstructed family, repeated drunkenness, daily smoking, cannabis experimentation, frequent evenings out, negative life appreciation and early menarche. DISCUSSION AND CONCLUSION: Identifying factors associated with early sexual initiation should help professionals to better take care of those high risk adolescent girls.

Caesarean section on request: a comparison of obstetricians' attitudes in eight European countries.

OBJECTIVE: To explore the attitudes of obstetricians to perform a caesarean section on maternal request in the absence of medical indication. DESIGN: Cluster sampling cross-sectional survey. SETTING: Neonatal Intensive Care Unit (NICU) associated maternity units in eight European countries. POPULATION: Obstetricians with at least 6 months clinical experience. METHODS: NICU-associated maternity units were chosen by census in Luxembourg, Netherlands and Sweden and by geographically stratified random sampling in France, Germany, Italy, Spain and UK. An anonymous, self-administered questionnaire was used for data collection. MAIN OUTCOME MEASURES: Obstetricians' willingness to perform a caesarean section on maternal request. RESULTS: One hundred and five units and 1,530 obstetricians participated in the study (response rates of 70 and 77%, respectively). Compliance with a hypothetical woman's request for elective caesarean section simply because it was 'her choice' was lowest in Spain (15%), France (19%) and Netherlands (22%); highest in Germany (75%) and UK (79%) and intermediate in the remaining countries. Using weighted multivariate logistic regression, country of practice (P<0.001), fear of litigation (P= 0.004) and working in a university-affiliated hospital (P= 0.001) were associated with physicians' likelihood to agree to patient's request. The subset of female doctors with children was less likely to agree (OR 0.29, 95% CI 0.20-0.42). CONCLUSIONS: The differences in obstetricians' attitudes are not founded on concrete medical evidence. Cultural factors, legal liability and variables linked to the specific perinatal care organisation of the various countries play a role. Greater emphasis should be placed on understanding the motivation, values and fears underlying a woman's request for elective caesarean delivery.

Disease modifying trials in Alzheimer disease: methodological and statistical issues.

In order to establish that a drug has an impact on disease progression, a clinical trial must study both the symptomatic and the disease modifying effect of the drug. Disease modifying trials raise some methodological issues with regard to the choice of the design (parallel arm versus two- period design), of the outcome (clinical versus surrogate) and of the statistical analysis (management of missing data).

[Socioeconomical status, health behaviors and health status of French adolescents: Health Behavior in School-aged Children (HBSC) survey]. / Statut socio-économique, comportements de santé et santé des adolescents français: l'enquête Health Behaviour in School-aged Children (HBSC).

BACKGROUND: The impact of living conditions on health is not well known, but health inequalities observed in adults seem partly determined by behaviours and health status at an earlier stage, and more particularly during adolescence. So, our aim was to study adolescents' health and their health behaviours function to family socioeconomic status. METHODS: We analysed French data from the international survey "Health Behavior in School-aged Children" carried out in a representative sample of adolescents aged 13 and 15 years in 1998. A self-administered questionnaire was completed by the adolescents who answered questions concerning their health, health behaviours, and their families' socio-economic status. RESULTS: Adolescents from blue-collar families were more numerous to report to be in "fairly good health" or "not very good health" (OR = 1.40, CI 95% = 1.12-1.74) and to be overweight or obese (OR = 1.85, CI 95% = 1.25-2.24) than those from executive families. They were also more numerous to have bad health behaviours than those from executive families. CONCLUSION: This study has established that, in adolescents, differences in health, health behaviours, types of consumption and physical activities depended on the families' socio-economic status.

[Self-evaluation of the quality of life of children aged 6 to 12 years old: construction and first steps in the validation of kidlQol, a generic computer-based tool]. / Auto-evaluation de la qualité de vie d'enfants de 6 a 12 ans: construction et premières etapes de validation du KidlQol, outil générique présenté sur ordinateur.

The KidlQol is a self-evaluation computer-based instrument to assess the quality of life of children aged 6 to 12 years old. This self-evaluation comprises three areas of their subjective quality of life: physical, psychological and social. A computer-assisted tool, composed of 62 items, was developed and set up based upon the results from the evaluation of the initial prototype tool which underwent a series validation steps, tested among children with and without psychological problems. This evaluation lead to the production of a final tool called KidlQuol, which is composed of 44 items. This tool, which utilises computer images to represent real-life situations, is adapted for and accessible to children with a French cultural background aged between 6 and 12 years old. As a generic tool, it could be used among a population of children with various types of handicaps, chronic diseases or psycho-social difficulties.

[Self-evaluation of the quality of life of children aged 6 to 12 years old: analysis of the concept and development of a prototype tool]. / Auto-evaluation de la qualité de vie d'enfants de 6 à 12 ans: analyse du concept et élaboration d'un outil prototype.

The objective of this work was to assess the quality of life of children aged 6 to 12 years old. The authors present the different conceptual and operational steps which lead to the construction of a prototype tool. It was a generic tool composed of 63 items which covered the classically described areas of life. Its originality was due to the method of construction used which included children's involvement, to the pictorial representation of real-life situations for children, and to its adaptation for gender. The evaluation of this tool showed a good level of acceptability but statistical analysis revealed some metrological inadequacies leading to the reconsideration of the initial concepts and their methods of exploration. Therefore a new tool was constructed whose validation is presented in a second article in the next issue.

Impact of nutritional status on the evolution of Alzheimer's disease and on response to acetylcholinesterase inhibitor treatment.

BACKGROUND: Weight loss is frequently observed in patients with Alzheimer's disease (AD), as observed in clinical practice and reported in the literature. However, information on the evolution of nutritional status and its impact on the prognosis of AD is still scarce. OBJECTIVE: Our aim was to determine the impact of nutritional status on the evolution of AD and on the response to treatment with acetylcholinesterase inhibitors (AChEI) by prospective one-year follow-up of AD patients living at home. METHODS: We studied a cohort of 523 patients with Alzheimer's disease referred from 1994 to 2002 to an Alzheimer centre. After diagnosis, they were followed for one year in a prospective observational study in clinical practice. At entry and every 6 months, patients underwent standardised neurocognitive and geriatric evaluation (MMSE, ADAS-cog, IADL, MNA, caregiver burden). These evaluations were accompanied by complete clinical examination, standard paraclinical investigations and recording of treatment received. RESULTS: Of our patients, 25.8% presented at inclusion a risk of undernutrition with an MNA score of 23.5 or less. During follow-up, the number of patients with rapid loss on the MMSE (3 points or more in one year) was higher in subjects who presented a risk of undernutrition at inclusion (53.6%) than in well-nourished subjects (43.2%) (P = 0.07). Similarly, increased dependence at one year was more frequent in subjects at risk of undernutrition at inclusion (57.7% versus 44.4%, P = 0.0219). The beneficial effect of AChEI treatment on cognitive function was not influenced by initial nutritional status; on the contrary, among the subjects at risk of undernutrition at inclusion, the risk of rapid loss on the MMSE in one year was decreased in subjects treated during follow-up compared with untreated subjects (43.9% versus 73.1% ; OR = 0.29; 95% CI = 0.10-0.83; P = 0.0219). This relationship was not found in subjects whose initial MNA score was greater than 23.5. CONCLUSION: Our work indicates that AD patients living at home with a caregiver are frequently at risk of undernutrition. Undernourished patients seem to present more rapid aggravation of the disease, but paradoxically, these patients appear to be those who best respond to AChEI treatment.

[Social and demographic characteristics and perinatal risks for highly deprived mothers]. / Caractéristiques socio-démographiques et risques périnatals des mères en situation de précarité.

OBJECTIVE: To assess the frequency of deprivation in pregnant women and estimate the associated medical risks. MATERIAL: and methods. A retrospective study of the hospital's computerised data (6149 women) and two prospective studies with health staff (n=534) and social workers (n=85) in two maternity hospitals. RESULTS: In the retrospective study, 17.5% of mothers were deprived. Deprivation was associated both with more difficulties during pregnancy and the perinatal period and with longer hospital stays. The prospective studies confirmed the prevalence of deprivation and gave a more detailed idea of the associated social and demographic characteristics. Deprivation was related with a combination of risk factors with a particularly important influence of economic risk. A quarter of deprived mothers had unwanted pregnancies and according to the social workers approximately 10% of them were not in a position to take care of their baby. CONCLUSION: This study emphasizes the importance of deprivation as a perinatal medical risk factor. Screening should take place in early pregnancy in order to find the best way to help such families.

Prevalence and main characteristics of schoolchildren diagnosed with food allergies in France.

BACKGROUND: A cross-sectional, descriptive, questionnaire-based survey was conducted in Toulouse schools to determine the prevalence of food allergies among schoolchildren. OBJECTIVES: The first goal of the survey was to estimate the prevalence of food allergies. The second goal was to determine the main characteristics of the allergies. METHODS: The questionnaires (3500) were distributed in 150 classes in eight schools. The return rate was 77.6% (2716). RESULTS: Of the 192 (7.0%) questionnaires with a 'Yes' response (report of a food allergy), 182 were retained as reporting true food allergies (6.7%). The cumulative and point prevalences were 6.7% [95% confidence interval (CI) 5.8-7.6] and 4.7% [95% CI 3.9-5.5], respectively. The point prevalences were 4.0% for the children aged 2-5 years, 6.8% for the children aged 6-10 years, and 3.4% for the children aged 11-14 years. The main foods reported as causing adverse reactions were cow milk (n = 29, 11.9%), eggs (n = 23, 9.4%), kiwis (n = 22, 9.0%), peanuts (n = 20, 8.2%), fish (n = 19, 7.8%), tree nuts (n = 19, 7.8%), and shrimp (n = 13, 5.3%). The average age at which the allergies were detected was 3.4+/-2.8 years (with a range of 0.1-12 years). The clinical signs of the food allergies were cutaneous (n=153, 62.7%), digestive (n = 74, 30.3%), respiratory (n = 17, 6.9%), and anaphylactic shock (n = 12, 4.9%). CONCLUSION: While well aware of the biases inherent in this type of study, we estimated the cumulative and point prevalences of food allergies in a population of school-age children in Toulouse at 6.7% and 4.7%, respectively. Cow milk, eggs, and peanuts were the main foods reported as causing allergies. Exotic fruits, shellfish, and tree nuts appeared to be relatively new allergens.

Does smoking in pregnancy modify the impact of antenatal steroids on neonatal respiratory distress syndrome? Results of the Epipage study.

OBJECTIVES: To assess the relation between cigarette smoking during pregnancy and neonatal respiratory distress syndrome (RDS) in very preterm birth, and to analyse the differential effect of antenatal steroids on RDS among smokers and non-smokers. DESIGN: A population based cohort study (the French Epipage study). SETTING: Regionally defined births in France. METHODS: A total of 858 very preterm liveborn singletons (27-32 completed weeks of gestation) of the French Epipage study were included in this analysis. The odds ratio for RDS in relation to smoking in pregnancy was estimated using a logistic regression to control for gestational age. The odds ratio for RDS in relation to antenatal steroids was estimated taking into account an interaction between antenatal steroids and cigarette smoking, using multiple logistic regression to control for gestational age, birthweight ratio, main causes of preterm birth, mode of delivery, and sex. RESULTS: The odds ratio for RDS in relation to smoking in pregnancy adjusted for gestational age (aOR) was 0.59 (95% confidence interval (CI) 0.44 to 0.79). The aOR for RDS in relation to antenatal steroids was 0.31 (95% CI 0.19 to 0.49) in babies born to non-smokers and 0.63 (95% CI 0.38 to 1.05) in those born to smokers; the difference was significant (p = 0.04). CONCLUSIONS: Cigarette smoking during pregnancy is associated with a decrease in the risk of RDS in very preterm babies. Although antenatal steroids reduce the risk of RDS in babies born to both smokers and non-smokers, the reduction is smaller in those born to smokers.

Survival of very preterm infants: Epipage, a population based cohort study.

OBJECTIVE: To evaluate the outcome for all infants born before 33 weeks gestation until discharge from hospital. DESIGN: A prospective observational population based study. SETTING: Nine regions of France in 1997. PATIENTS: All births or late terminations of pregnancy for fetal or maternal reasons between 22 and 32 weeks gestation. MAIN OUTCOME MEASURE: Life status: stillbirth, live birth, death in delivery room, death in intensive care, decision to limit intensive care, survival to discharge. RESULTS: A total of 722 late terminations, 772 stillbirths, and 2901 live births were recorded. The incidence of very preterm births was 1.3 per 100 live births and stillbirths. The survival rate for births between 22 and 32 weeks was 67% of all births (including stillbirths), 85% of live births, and 89% of infants admitted to neonatal intensive care units. Survival increased with gestational age: 31% of all infants born alive at 24 weeks survived to discharge, 78% at 28 weeks, and 97% at 32 weeks. Survival among live births was lower for small for gestational age infants, multiple births, and boys. Overall, 50% of deaths after birth followed decisions to withhold or withdraw intensive care: 66% of deaths in the delivery room, decreasing with increasing gestational age; 44% of deaths in the neonatal intensive care unit, with little variation with gestational age. CONCLUSION: Among very preterm babies, chances of survival varies greatly according to the length of gestation. At all gestational ages, a large proportion of deaths are associated with a decision to limit intensive care.