[Systematic analysis of evaluations of Objective Structured Clinical Exam (OSCE) multiple circuits: Explanatory variables and inter-rater correlations]. / Analyse systématique des évaluations de circuits multiples d'examen clinique objectif structuré (ECOS) : variables explicatives et corrélations inter-évaluateurs.

INTRODUCTION: Objective Structured Clinical Examinations (OSCEs) assess professional performance in a simulated environment. Following their integration into the reform of the 2nd cycle of medical studies (R2C), this pedagogical modality was implemented in France. This study investigates the variability of students' OSCE scores, as well as their inter-rater reproducibility. METHODS: This single-center retrospective study covered several sessions of evaluative OSCE circuits conducted between January 2022 and June 2023. Variables collected were: baseline situation family, competency domain, presence of a standardized participant for stations; gender and professional status for evaluators; scores (global, clinical and communication skills), number of previously completed OSCE circuits and faculty scores for students. RESULTS: The variability of the overall score was explained mainly (79.7%, CI95% [77.4; 82.0]) by the station factor. The student factor and the circuit factor explained 7.5% [12.9; 20.2] and<0.01% [2.10-13; 2.10-9] respectively. The inter-rater intra-class correlation coefficient was 87.2% [86.4; 87.9] for the global score. Station characteristics (starting situation, domain) and evaluator characteristics (gender, status) were significantly associated with score variations. CONCLUSION: This first study on the variability of OSCE circuit scores in France shows good reproducibility with influence of station characteristics. In order to standardize circuits, variability linked to the domain competency should be considered as well.

Psycho-organizational and medical factors in burnout in French medical and surgery residents.

Hospital residency is stressful, with a risk of burnout. To assess the prevalence of burnout in medical and surgical residents and identify psycho-organizational and medical risk factors with a view to prevention. A transverse study was conducted in France between September 2018 and November 2018, targeting 633 hospital residents. A self-administered questionnaire was delivered by e-mail. Burnout was assessed on the Maslach Burnout Inventory, anxiety/depression on the Hospital Anxiety and Depression Scale (HAD) and stress on a visual analogue scale (VAS). Two-hundred and sixteen of the targeted residents (34%) responded. Twenty-three (12%) showed severe burnout in all three dimensions, severe loss of empathy being the most frequent. Almost one-third showed symptoms of anxiety. Residents exposed to psycho-organizational constraints (stress, time pressure, intense work rhythm) and/or with symptoms of anxiety/depression more frequently showed burnout. Prevention of burnout requires reinforced medical monitoring and reduced psycho-organizational constraints.

SARS-CoV-2 infection: advocacy for training and social distancing in healthcare settings.

This article reports the observed rate of infection with severe acute respiratory syndrome coronavirus-2 in healthcare workers (HCWs) who worked on wards dedicated to care of patients with coronavirus disease 2019 (COVID-19) compared with HCWs who worked on non-COVID-19 wards. The infection rate was significantly higher among HCWs who worked on non-COVID-19 wards (odds ratio 2.3, P=0.005), illustrating the need to strengthen social distancing measures and training.

Medical and socio-occupational predictive factors of psychological distress 5 years after a road accident: a prospective study.

PURPOSE: Psychosocial consequences of road accidents are a major clinical problem that incurs significant social, occupational, and economic costs. The purpose of our study was to assess medical and socio-occupational factors of psychological distress in the severely injured 5 years after a road accident. METHODS: A total of 691 of the 1168 subjects enrolled in a prospective cohort of road accident casualties (ESPARR cohort) responded to both standardized follow-up questionnaires at 1 and 5 years, assessing socio-occupational characteristics, physical and psychological sequelae, pain and perceived quality of life. RESULTS: One quarter of participants exhibited psychological distress 5 years after the road accident; most of whom are women, with low educational level, and suffering from spinal lesions. After adjusting for several factors, psychological distress at 5 years was predicted by female gender and low educational level, and by several other factors observed 1 year after the road accident: poor self-reported quality of life, attention deficit and symptoms of anxiety. CONCLUSIONS: Early-stage improvement in the screening and care of mental disorders in road accident casualties should help to reduce long-term psychological distress.

Working conditions and risk exposure of employees whose occupations require driving on public roads - Factorial analysis and classification.

INTRODUCTION: Several studies of the working conditions of drivers, and in particular on their pace of work, have enabled a better understanding of the risk factors for road accidents that occur during work. However, few studies are available on the risk exposure and working conditions of employees whose occupations involve driving. The purpose of this paper is to identify the different groups of employees occupationally exposed to road risk and to classify them according to working conditions. METHODOLOGY: A Multiple Correspondence Analysis (MCA) was implemented on the 41,727 individuals from the SUMER 2010 survey (Medical Monitoring of Occupational Risk Exposure: SUrveillance Médicale des Expositions aux Risques professionnels) and for 45 variables about working conditions. The analysis used 5 categories of weekly driving exposure as a supplementary variable (variable which is not used to perform the MCA): Non-exposure; Exposed <2 h; Exposed 2-10 hours; Exposed 10-20 hours; and Exposed >20 h. The results of the MCA were used to construct an ascending hierarchical classification. RESULTS: The first factorial axis differentiates between conventional and unconventional work schedules. Axis 2 differentiates modalities corresponding to the working hours of the most recent working week. The third axis chiefly contrasts persons who have rules to follow with those who have none. An ascending hierarchical classification distinguishes 10 clusters of individuals according to working conditions. Four clusters of employees were excessively exposed to occupational driving. Clusters also have distinct demographic, occupational and psychosocial characteristics. CONCLUSION: Analysis of data from the SUMER survey confirms that employees exposed to road risk are particularly affected by atypical work time characteristics, but can be found in all activity sectors and in all types of job.

Implementation of a self-administered questionnaire to detect lung carcinogens.

BACKGROUND: Between 10 and 20% of lung cancers are of occupational origin. Screening for occupational risk factors is part of the diagnostic workup. A self-administered questionnaire to detect lung carcinogens of occupational origin, the RECAP questionnaire, was drawn up and validated with a view to limiting under-declaration of lung cancer as an occupational disease (OD). AIMS: Optimal administration conditions were investigated, to facilitate systematic use in the management of patients admitted to hospital with lung cancer. METHODS: The various care pathways of lung cancer patients were first studied in two centres, to identify the health-care professionals involved in medical management, the various care sites and the stages of treatment. A focus group of health-care professionals was set up, and semi-directive interviews were conducted with 24 patients. RESULTS: Caregivers tended to suggest that a physician or nurse should present the RECAP questionnaire, whereas patients rather chose non-caregiver staff, seeing the undertaking as being 'administrative' in nature. Some caregivers and patients thought the questionnaire should not be administered at the outset of treatment, due to the psychological trauma entailed by diagnosis. Administration during chemotherapy was recommended by patients, as they are more freely available at that time, and by caregivers, who thought patients better able to pay attention then. CONCLUSIONS: The study highlighted patients' lack of information on how lung cancer can be recognized as an OD. Implementing the RECAP questionnaire should facilitate patients' claims for insurance cover for lung cancer as an OD.

Road casualties in work-related and private contexts: occupational medical impact. Results from the ESPARR cohort.

BACKGROUND: Road accidents may impact victims' physical and/or mental health and socio-occupational life, notably including return to work. OBJECTIVES: To assess whether the occupational medical consequences sustained by subjects injured in road accidents occurring in a work-related context differ from those associated with private accidents. METHODS: 778 adults who were in work or occupational training at the time of their accident were included. Two groups were distinguished: 354 (45.5%) injured in road accidents occurring in a work-related context (commuting or on duty) and 424 (54.5%) injured in a private accident. The groups were compared on medical and occupational factors assessed on prospective follow-up at 6 months and 1 and 3 years. Multivariate analysis explored for factors associated at 6 months and 1 year with sick leave following the accident and duration of sick leave. RESULTS: There were no significant differences between groups for demographic data apart from a slightly higher injury severity in private accidents (32.5% of private accidents with MAIS3+(Maximum Abbreviated Injury Scale greater or equal to 3) vs. 23.7% for work-related accidents, p = 0.007). Victims of work-related accidents were more often on sick leave (OR = 1.8; 95% CI, 1.1-2.9). Although the length of sick leave is higher for work-related accidents that for private accidents, multivariate analysis showed that the injury severity and the post-traumatic stress disorder (PTSD) are significant factors to explain the time to return to work. There were no significant differences according to occupational impact during follow-up, notably including sick-leave duration, number of victims returning to work within 3 years and number of victims out of work due to incapacity. CONCLUSIONS: In the ESPARR (follow-up study of a road-accident population in the Rhône administrative county: Etude de Suivi d'une Population d'Accidentés de la Route dans le Rhône) cohort, the fact that a road accident occurred in a work-related context did not affect the occupational consequences.

Factors associated with non-return to work in the severely injured victims 3 years after a road accident: A prospective study.

Road accidents may impact victims' physical and/or mental health and socio-occupational life, particularly the capacity to return to work. The purpose of our study is to assess modifiable medical and socio-occupational factors of non-return to work in the severely injured 3 years after a road accident. Among1,168 road accidents casualties in the Rhône administrative Département of France followed for five years, 141 of the 222 severely injured (Maximal Abbreviated Injury Scale ≥ 3) aged more than 16 years who were in work at the time of the accident, reported whether they had returned to work in the 3 years following the accident. The subgroups of those who had (n=113) and had not returned to work (n=28) were compared for socio-occupational (gender, age, educational level, marital status, socio-occupational group) accident-related medical factors (type of road user, type of journey, responsibility in the accident, initial care) and post-accident medical factors (pain intensity, post-traumatic stress disorder, physical sequelae, quality of life) by using standardized tools. Severity of initial head, face and lower-limb injury, intense persistent pain, post-traumatic stress disorder, poor self-assessed quality of life and health status at 3 years were associated with non-return to work on univariate analysis. On multivariate analysis, severity of initial head and lower-limb injury, intense persistent pain at 3 years and post-traumatic stress disorder were significantly associated with non-return to work 3 years following severe road-accident injury. Post-traumatic stress disorder and chronic pain were essential modifiable medical determinants of non-return to work in the severely injured after a road accident: early adapted management could promote return to work in the severely injured. Improve early adapted treatment of pain and PTSD in the rehabilitation team should help the severely injured return to work following a road accident.

Design and validation of a self-administered questionnaire as an aid to detection of occupational exposure to lung carcinogens.

OBJECTIVE: Ten to thirty percent of lung cancer is thought to be of occupational origin. Lung cancer is under-declared as an occupational disease in Europe, and most declarations of occupational disease concern asbestos. The purpose of this study was to design and validate a short, sensitive self-administered questionnaire, as an aid for physicians in detecting occupational exposure to asbestos and other lung carcinogens in order to remedy occupational lung cancer under-declaration. STUDY DESIGN: Cross-sectional study. METHODS: A short (30-question) self-administered questionnaire was drawn up by oncologist-pneumologists and occupational physicians, covering situations of exposure to proven and probable lung carcinogens. Understanding and acceptability were assessed on 15 lung cancer patients. Validity and reliability were assessed on 70 lung cancer patients by comparison against a semi-directive questionnaire considered as gold standard. Sensitivity and specificity were assessed by comparing responses to items on the two questionnaires. Reliability was assessed by analysing the kappa concordance coefficient for items on the two questionnaires. RESULTS: Sensitivity was 0.85 and specificity 0.875. Concordance between responses on the two questionnaires was 85.7%, with a kappa coefficient of 0.695 [0.52-0.87]. Mean self-administration time was 3.1 min (versus 8.12 min to administer the gold-standard questionnaire). In 16 patients, the self-administered questionnaire detected lung carcinogen exposure meeting the criteria for occupational disease. CONCLUSION: The present short, easy-to-use self-administered questionnaire should facilitate detection of occupational exposure to lung carcinogens. It could be used in occupational lung cancer screening and increase the presently low rate of application for recognition of lung cancer as an occupational disease.

Impaired mental well-being and psychosocial risk: a cross-sectional study in female nursing home direct staff.

OBJECTIVES: The present study sought to quantify the impaired mental well-being and psychosocial stress experienced by nursing home staff and to determine the relationship between impaired mental well-being assessed on the 12-item General Health Questionnaire (GHQ-12) and exposure to psychosocial stress assessed on Siegrist's effort/reward and overcommitment model. METHODS: A transverse study was conducted in France on 2471 female employees in 105 nursing homes for the elderly. Personal and occupational data were collected by questionnaire for 668 housekeepers, 1454 nursing assistants and 349 nurses. RESULTS: 36.8% of participants (n=896) showed impaired mental well-being, 42.7% (n=1039) overcommitment and 9% (n=224) effort/reward imbalance. Overcommitment (prevalence ratio (PR)=1.27; 95% CI (1.21 to 1.34)) and effort-reward imbalance (PR=1.19; 95% CI (1.12 to 1.27)) were significantly associated with presence of impaired mental well-being after adjustment for personal factors (age and private life events). Taking effort and reward levels into account, the frequency of impaired mental well-being was highest in case of exposure to great extrinsic effort and low rewards of any type: esteem, PR=3.53, 95% CI (3.06 to 4.08); earnings, PR=3.48, 95% CI (2.99 to 4.06); or job security, PR=3.30, 95% CI (2.88 to 3.78). Participants in situations of overcommitment and of effort/reward imbalance were at the highest risk of impaired mental well-being: PR=3.86, 95% CI (3.42 to 4.35). CONCLUSIONS: Several changes in nursing home organisation can be suggested to reduce staff exposure to factors of psychosocial stress. Qualitative studies of the relation between impaired mental well-being and psychosocial stress in nursing home staff could guide prevention of impaired mental well-being at work.

Factors influencing return to work after illness in France.

BACKGROUND: Few studies have been published about the factors influencing return to work after sickness absence. AIMS: To identify medical and occupational factors influencing the type of fitness certificate given by occupational physicians before employees return to work after sickness absence. METHODS: A cross-sectional study was undertaken over 3 months in several health services in France. Workers undergoing a medical examination before returning to work after a period of sickness absence of at least 3 weeks were included. Medical and occupational factors were collected using a questionnaire. The relationship between different factors and certification of fitness was assessed by univariate and multivariate analyses. RESULTS: Among the 402 workers included, 64% were considered fit to return to work. Being older, strenuous work, prolonged sick leave and fear of returning to work appeared to be negative factors influencing the return to a previous job. In contrast, having an education level higher than secondary school, being satisfied at work, perception of very good health and benefitting from satisfactory professional relationships appeared to favour return to work. We developed a predictive score of not being fit to return to work after illness. CONCLUSIONS: Our study highlighted the relationship between medical and occupational factors with problems returning to work. The predictive score may be used by occupational physicians as a screening tool to identify those who are likely to have difficulties returning to work after illness, so that their working conditions can be modified to take this into consideration.

[Forgetting hormonal contraceptive methods: expert opinion about their daily management in clinical routine practice]. / Oublis de la contraception hormonale : réflexions sur leur prise en charge en pratique quotidienne.

Many guidelines regarding the daily management of regular oral hormonal contraceptive methods have been proposed worldwide. Some of them may even appear to be conflicting. The search for the maximal contraceptive protection leads to a low acceptance of these guidelines, probably because of their complexity and their apparent discrepancy. We are deeply convinced that simplicity and pragmatism of guidelines should pave the way to both their better acceptance and compliance and, consequently, to their improved real-life effectiveness. We have considered physiology and pharmacodynamics before proposing the following rules for an effective management of hormonal contraceptive failures. We conclude that the risk of unwanted pregnancy is higher in case of a unique contraception misuse/a delayed start during the first week of the contraceptive cycle (or in case of multiple days of contraceptive misuses during the following weeks) for a combined contraception or at every cycle day for a non anti-ovulatory progestin only contraception. In such risky situations, we firmly recommend the restart of the regular contraceptive method and the use of condoms for the following 72 hours, provided no sexual intercourse has occurred during the past 5 days before the contraceptive failure. If sexual intercourse has occurred during the past 5 days before the contraceptive failure, we firmly recommend the intake of an emergency contraception, ulipristal acetate, the restart the regular contraceptive method and in this case, the use of condoms for, at least, the following 7 days.

Did the introduction of maize into Europe provide enemy-free space to Ostrinia nubilalis? Parasitism differences between two sibling species of the genus Ostrinia.

We examined whether maize offers enemy-free space (EFS) to its pest Ostrinia nubilalis, and may thereby have contributed to its divergence from the sibling species, Ostrinia scapulalis, feeding mainly on mugwort, when introduced into Europe five centuries ago. We collected Ostrinia larvae on maize (70 populations, 8425 individuals) and mugwort (10 populations, 1184 individuals) and recorded parasitism using both traditional (counting emerging parasitoids) and molecular methods (detection by specific polymerase chain reaction). The main parasitoid was Macrocentrus cingulum (Braconidae). On mugwort, parasitism was twice that on maize, and parasitoid-related mortality was 8 times higher. This suggests that maize affords substantial EFS to Ostrinia feeding on it. The lower Mortality:Infestation ratio in maize suggests that O. nubilalis' immune response might be stronger than that of O. scapulalis. If so, adapting to maize and diverging from O. scapulalis would decrease the impact of parasitism on O. nubilalis at both ecological and evolutionary levels.

A lipid-parameter-based index for estimating insulin sensitivity and identifying insulin resistance in a healthy population.

AIM: Insulin resistance needs to be identified as early as possible in its development to allow targeted prevention programmes. Therefore, we compared various fasting surrogate indices for insulin sensitivity using the euglycaemic insulin clamp in an attempt to develop the most appropriate method for assessing insulin resistance in a healthy population. METHODS: Glucose, insulin, proinsulin, glucagon, glucose tolerance, fasting lipids, liver enzymes, blood pressure, anthropometric parameters and insulin sensitivity (Mffm/I) using the euglycaemic insulin clamp were obtained for 70 normoglycaemic non-obese individuals. Spearman's rank correlations were used to examine the association between Mffm/I and various fasting surrogate indices of insulin sensitivity. A regression model was used to determine the weighting for each variable and to derive a formula for estimating insulin resistance. The clinical value of the surrogate indices and the new formula for identifying insulin-resistant individuals was evaluated by the use of receiver operating characteristic (ROC) curves. RESULTS: The variables that best predicted insulin sensitivity were the HDL-to-total cholesterol ratio, the fasting NEFA and fasting insulin. The use of the lipid-parameter-based formula Mffm/I=12x[2.5x(HDL-c/total cholesterol)-NEFA] - fasting insulin appeared to have high clinical value in predicting insulin resistance. The correlation coefficient between Mffm/I and the new fasting index was higher than those with the most commonly used fasting surrogate indices for insulin sensitivity. CONCLUSION: A lipid-parameter-based index using fasting samples provides a simple means of screening for insulin resistance in the healthy population.

Differences in oviposition behaviour of two sympatric sibling species of the genus Ostrinia.

Changes in host preferences are thought to be a major source of genetic divergence between phytophagous insect taxa. In western Europe, two sympatric taxa, O. nubilalis (the European corn borer) and O. scapulalis, feed mainly on maize and hop or mugwort, respectively. These two species may have diverged without geographic isolation after a host shift of ancestral populations onto maize or another cultivated species (e.g. sorghum). A previous study using inbred laboratory strains revealed that the two species differ in their oviposition choices in maize-mugwort tests. We sampled four natural populations in France (two of each taxon) and tested their oviposition behaviour toward four of their main host plant species: maize, sorghum, mugwort and hop. O. nubilalis females showed a very high preference for laying their eggmasses on maize, whereas O. scapulalis females displayed a more balanced range of preferences. O. nubilalis females were attracted slightly to sorghum, suggesting that this plant is an accidental, rather than a regular and ancestral host plant of O. nubilalis. One important result arising from this study is the significant proportion of eggs laid by both Ostrinia species on hop. This may explain why some stands of hop are sometimes not only infested by O. scapulalis but also by O. nubilalis larvae, a situation preventing assortative mating based on microallopatry. Hence, further studies must be conducted to see whether the host preference in the genus Ostrinia might be linked to assortative mating by a mechanism that is not mediated by the host plant.

[Effects of a 19-norprogesterone derivative, the fourth decade nomegestrol acetate, on lipids]. / Effets sur les lipides d'un progestatif 19-norprégnane. Le nomégestrol acétate.

Dyslipidemia is a cardiovascular risk factor which commonly develops during forty. In Europe, progestins are frequently prescribed for treatment of perimenopausal symptoms in women in this age group, as well as in combination with estrogen replacement therapy in non hysterectomised postmenopausal women. Their complete metabolic tolerance is an important, even if non exclusive, factor to take in consideration for cardiovascular protection. Our aim was to review available data on the effects of a 19-norprogesterone derivative, nomegestrol acetate, on lipid tolerability. In healthy or at risk premenopausal women, clinical studies found no significant changes in lipid parameters (total, HDL and LDL cholesterol, triglycerides, apoprotein B, Lp(a) and LpA-I) with nomegestrol acetate administered in antigonadotropic sequence, alone or combined with estrogen in inverse sequence, during 6 to 9 cycles; there was only a small statistically significant decrease in apoprotein A1, probably due to the induced hypoestrogeny. In clinical studies carried out in postmenopausal women, nomegestrol acetate combined with estrogen replacement therapy in a sequential or continuous combined regimen, did not alter the beneficial estrogen-induced lipid profile: reductions in total and LDL cholesterol, apoprotein B and Lp(a); HDL cholesterol was unchanged and an increase in triglycerides occurred only with oral estrogens. A decrease in apoprotein A1 was found after six months of a cyclic sequential hormone replacement therapy but was associated with a beneficial increase in LpA-I. Nomegestrol acetate has proven its neutral effects on lipid metabolism and does not alter the beneficial estrogen-induced lipid effects.

Changes in body composition during post-menopausal hormone therapy: a 2 year prospective study.

BACKGROUND: Post-menopausal hormone therapy (pHT) induces changes in both body composition and bone mineral density (BMD). METHODS: In 109 post-menopausal women beginning either tibolone 2.5 mg (n=29), tibolone 1.25 mg (n=42) or estradiol 2 mg plus norethisterone acetate 1 mg (E2 + NETA) (n=38), we assessed body composition, total and regional BMD by dual energy X-ray absorptiometry, and the serum bone alkaline phosphatase (BAP), osteocalcin and the urinary excretion to type I collagen C-telopeptide (CTX) at baseline and after 2 years. RESULTS: At baseline, BMD at all sites correlated negatively with age and years since menopause, and positively with lean mass and fat mass (r=0.42, P<0.001 and r=0.26, P=0.006 at the total femur). During treatment, BMD increased at all sites (P<0.001), and serum BAP, osteocalcin, and urinary CTX decreased in all groups (P<0.001). Lean mass increased whereas android fat and android obesity index decreased. The increase in BMD at all sites correlated positively with changes of lean mass at 2 years. CONCLUSIONS: Both fat mass and lean mass are related to BMD in post-menopausal women, the relationship being strongest with lean mass; an increase in lean mass and a change in distribution of body fat are observed during treatment with E2 + NETA and tibolone.

[Oral contraception in France in 2001: results of an opinion poll survey conducted on 3609 women between 15 and 45]. / La contraception orale en France en 2001: résultats d'une enquête par sondage portant sur 3609 femmes âgées de 15 à 45 ans.

OBJECTIVES: The aim of this study concerning the taking of the pill in France in 2001 was threefold, i.e. to assess its rate as well as its characteristics of use, and to appraise the most frequent side effects as reported by women. MATERIAL AND METHOD: Three thousand six hundred and nine women representative of the French female population between 15 and 45 years of age were recruited thanks to a survey, which took place in 2001. The data were collected from self-questionnaires. RESULTS: Women on the whole have quite a good opinion of oral contraception and most of them are convinced of its efficiency. As far as pill tolerance is concerned, opinions do vary, more than half of the women judging that being on the pill is not without side-effects. Though, the rate of use of oral contraceptives has increased by 12% since 1994. Most women (48%) use first and second generation pills and this in all age brackets. Thirty per cent of women aged 30 to 45 keep loyal to the same patent medicine, which they keep using for more than 10 years. Among the side-effects that can be found, two of them--putting on weight (31%) and hydrosodium retention (26%)--are the most frequently quoted, in all age brackets. This accounts for the relatively low ratio of women who find their pill quite satisfactory (58% of the cases). DISCUSSION AND CONCLUSION: Despite the diversity of all the different patented pills that are available, efforts are still to be made in order to reduce what side-effects are encountered when using them.

[Factors associated with weight gain in women using oral contraceptives: results of a French 2001 opinion poll survey conducted on 1665 women]. / Facteurs associés à la prise de poids chez les femmes utilisant des contraceptifs oraux: enquête par sondage réalisée en 2001 auprès de 1665 femmes.

OBJECTIVES: To study how often women put on weight when on the pill and to analyse the relationship between that gain in weight and the characteristics of the last 2 types of pill that had been used. PATIENTS AND METHODS: Three thousand six hundred and nine women representative of the French female population, aged 15 to 45, were recruited thanks to a survey that took place in 2001. Our study mainly concerned the 1665 women who were actually taking the pill at the time of the survey. The data were collected from self-questionnaires. RESULTS: Thirty per cent of women declared to have gained weight since using their latest pill - only one more kg for 4% of them, 2 kg for 10% but 3 kg or more for the remaining 16%. Gain in weight was more frequent with women less than 25 years of age (35%) than with older ones (29%). This gain in weight did not vary according to either the type of pill, which was then used, or the length of time spent in using it, or the age of first using. It was more frequent when found with other side effects such as breast pain, skin disorders or metrorrhaegias; it was less frequent among women who had already been on the pill in the past than among women using an oral contraceptive for the first time (28% vs 34%; P = 0.008). The shorter the taking the latest pill had been, the greater the frequency of gain in weight was (P = 0.005), women who had presented the most side-effects in the past having changed their pill more rapidly than other women. Finally, a gain in weight was found far more often in women who "did" put on weight with their latest pill than in those who "did not" (53% vs 14%; P = 0.0001). All in all, 8% of women who had been previously been taking the pill had given up this method over a weight problem. DISCUSSION AND CONCLUSION: Putting on weight when on the pill being in the long term independent of the type of patent medicine used, it would seem necessary to orientate new research centred both on a chemical and a biological as well as a nutritional approach, so as to answer one of the major preoccupations of oral contraceptive users to the fullest.

Randomized, double-masked, 2-year comparison of tibolone with 17beta-estradiol and norethindrone acetate in preventing postmenopausal bone loss.

In this 2-year, randomized study, we compared the efficacy and tolerability of tibolone 2.5 mg (n = 75), tibolone 1.25 mg (n = 76) and estradiol 2 mg plus norethindrone acetate 1 mg (E2/NETA: n = 74) for preventing bone loss in postmenopausal women. Bone mineral density (BMD), measured by dual-energy X-ray absorptiometry, and bone remodeling markers were assessed every 6 months. Side-effects were assessed quarterly. After 24 months, the mean increase (+/- SD) in lumbar spine BMD from baseline was 3.6% +/- 2.9%, 1.9% +/- 3.5% and 6.8% +/- 4.5% in the tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA groups, respectively. All pairwise differences were significant. The proportion of responders (women with a change from baseline in lumbar spine BMD of > or = -2% after 2 years) was 95.7%, 89.0% and 98.5% with tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA, respectively. Similar results were obtained for femoral BMD, although the difference between tibolone 2.5 mg and E2/NETA was not significant at 24 months. Decreases in bone remodeling markers were similar in the three groups. Vaginal bleeding was more common in the E2/ NETA group (33.8%) than with tibolone 2.5 mg (12.0%) or tibolone 1.25 mg (9.2%), as was breast pain (23.0%, 2.7% and 2.6%, respectively). Each treatment effectively prevented bone loss. Overall, tolerability of tibolone was better than with E2/NETA, because of less frequent vaginal bleeding and breast pain. This may promote long-term adherence.