Feedback and lessons from the prescription of rimonabant, a drug to be used under strict guidelines, in southeastern France, March 2007 through June 2008.

BACKGROUND: To provide feedback on the initial market authorization of rimonabant, a drug to be used under strict guidelines, we conducted a study with information from the National health insurance reimbursements database for southeastern France. The aims of this study were to: (1) describe the characteristics of subjects who have had one rimonabant prescription reimbursed; (2) study the frequency of prescriptions that did not comply with reimbursement criteria; (3) study the frequency of prescriptions for patients simultaneously treated with antidepressants; and (4) analyse the factors associated with both types of prescription (patient and prescriber characteristics). METHODS: Using the database of drug reimbursements maintained by the southeastern France general health insurance fund, we studied the characteristics of outpatients with at least one reimbursement for rimonabant, compared them to the rest of the population, and analysed compliance with the indications, contraindications, and regulations for rimonabant prescription with multivariate logistic regressions. RESULTS: A total of 10,510 beneficiaries (0.28%) had at least one rimonabant reimbursement. Among them, 55.7% were treated for diabetes. For at least 62.4% of rimonabant beneficiaries, the reimbursement regulations were not respected: this was significantly more frequent among women less than 57 years old, subjects with no chronic diseases, and when the prescriber was not an endocrinologist; 11.4% of rimonabant beneficiaries also received an antidepressant treatment. CONCLUSION: Despite the specific status of rimonabant regarding its reimbursement modalities, these results suggest that some prescribers get around reimbursement instructions and that a significant percentage of prescriptions did not respect an important contraindication. Tools to follow up the prescriptions of new drugs with strict guidelines for use should be developed and physicians should be better informed and trained regarding specific prescription regulations.

[Lung signal on fetal MRI: normal values and usefulness for congenital diaphragmatic hernia]. / Signal pulmonaire foetal en IRM: valeurs normales et application à la hernie diaphragmatique congénitale.

PURPOSE: To demonstrate the feasibility of lung signal measurements on fetal MRI, present normal signal intensity curves, and assess its value to predict pulmonary hypoplasia. PATIENTS AND METHODS: Prospective multicentric study of 115 fetuses without lung disease and 33 fetuses with left diaphragmatic hernia and high risk of pulmonary hypoplasia. Signal measurements were obtained of the lungs, liver and psoas from fast heavily T2W sequences (HASTE, 2 measurements and 2 orthogonal planes for each organ, oval-shaped ROI of 1 cm2 for lungs and liver, and 0.5 cm2 for the psoas). RESULTS: No direct linear relationship existed between lung signal intensity and gestational age. A direct linear relationship existed between liver signal and gestational age, and between psoas signal and gestational age. An exponential relationship existed for the ratios left lung/liver, right lung/liver, left lung/psoas and right lung/psoas. The inter-observer agreement was excellent, ranging between 0.888 and 0.926. Significant differences were observed between normal fetuses and fetuses with diaphragmatic hernia for the right lung/liver and left lung/psoas ratios. CONCLUSION: Normal fetal lung signal intensity curves can be obtained. Lungs at risk of hypoplasia presented significant alterations of signal ratios. The prognostic value of such results requires additional postnatal clinical follow-up.

[Bone remodeling around cementless tantalum cups]. / Etude du remodelage osseux autour de cupules non cimentées en tantale.

PURPOSE OF THE STUDY: Most studies have reported a significant decrease in periacetabular bone stock one year after implantation of a cementless cup. The purpose of this work was to study the bone-implant interface of the tantalum cup using plain X-rays and dual-energy X-ray absorptiometry (DEXA). MATERIAL AND METHODS: This retrospective analysis concerned 42 patients with a tantalum cup, Trabecular Metaltrade mark (Zimmer, Warsaw, IN, USA). All hips had primary implantations, performed by one surgeon via the same approach and with the same postoperative rehabilitation protocol. Minimum follow-up was two years. The Harris clinical score, and radiographic (lucent lines and acetabular position) and densitometric (analysis of 3.3mm of periacetabular bone in the three DeLee and Charnley zones) were recorded. RESULTS: At follow-up, the mean Harris score was 81. There were no implant malpositions (horizontal, vertical, inclination). Lucent lines were noted for 14% of the cups. Bone mineral density (BMD) was higher than generally observed with cementless cups (1.290+/-0.309g/cm(2)). DISCUSSION: The clinical and radiographic results are similar to data in the literature regarding correct implant position. The higher rate of lucent lines around the tantalum cup is also reported in the literature and is the result of the pressfit, resolving at one year. The greater BMD in zone 1 might reflect better force transfer to the weight-bearing zone. CONCLUSION: As biomaterial recently introduced in orthopedic surgery, tantalum appears to provide a better force transfer to the central part of the iliac bone and thus possibly better preservation of pelvic bone stock.

[Should minor salivary gland biopsy still be performed?]. / Faut-il encore effectuer des biopsies des glandes salivaires accessoires?

INTRODUCTION: Labial salivary gland biopsy (LSGB) is a very useful technique that is often performed in our specialty. A lot of these LSGB yield normal results and the interest of this technique may be discussed. This study was made to answer two questions: one on the diagnostic interest of LSGB for the suspected pathology, secondly to verify if there was a correlation between the results of LSGB assessment and the patient's final diagnosis. MATERIAL AND METHODS: Ninety-six LSGB were performed in 2004 for Sjögren syndrome, sarcoidosis, amyloidosis and other auto-immune diseases. The histological study assessed the Chisholm-Mason score and screened for amyloidosis and sarcoidosic granuloma. The prescribing unit gave the final diagnosis. RESULTS: The LSGB was very specific (100% of specificity) and there were no false positive results; conversely, its sensitivity was lower, that is 75% for Sjögren syndrome, 67% for amyloidosis, 60% for sarcoidosis and 14% for other auto-immune disease (not defined). DISCUSSION: LSGB can be recommended for Sjögren syndrome; it is also useful for amyloidosis. In sarcoidosis it gives poor results and presents no interest for other auto-immune diseases. The LSGB prescribed for patients with a suspected initial single diagnosis (Sjögren syndrome only, or amyloidosis only, or sarcoidosis only, or an other auto-immune disease only) significantly increases the specificity and the sensitivity of the technique and suggests that specificity and sensitivity are linked to patient selection and not to LSGB itself.

[Value of the Norwood-Sano compared with the classical Norwood procedure in hypoplastic left heart syndrome]. / Intérêt de l'intervention de Norwood-Sano par rapport à l'intervention classique de Norwood dans l'hypoplasie du coeur gauche.

Palliative treatment of the hypoplastic left heart syndrome is rarely practiced in France because of the poor prognosis of the first surgical stage of the Norwood procedure. The recent modification proposed by Sano seems to give more promising results. The authors report their experience with the Norwood-Sano procedure compared with the classical Norwood procedure in 13 neonates with hypoplasia of the left heart. From 1999 to 2005, 8 patients underwent the classical Norwood procedure (1999-2001) and 5 had the Sano modification (2002-2005). During the preoperative period, there was 1 case of a very restrictive interatrial septum and 5 patients required mechanical ventilation. The patients were operated at an average age of 8.5 +/- 12 days. The results showed that survival after the first surgical stage was significantly better with the Sano modification (12.5% versus 80%; p= 0.03). All patients who survived the first stage went on to the second stage with a bi-directional right superior cavo-pulmonary derivation at an average of 6.1 +/- 2.4 months. Despite the infundibulotomy of the Sano modification, no arrhythmia or right ventricular dysfunction was observed after an average follow-up of 21.7 +/- 7.6 months. The authors conclude that the Sano modification improved survival of patients with hypoplasia of the left heart after the first palliative surgical procedure. The long-term follow-up of patients operated by this technique should particularly look out for arrhythmias and right ventricular dysfunction.

Outcome of acute fulminant myocarditis in children.

OBJECTIVES: To highlight clinical features and outcome of acute fulminant myocarditis (AFM) in children. METHODS: Diagnostic criteria were (1) the presence of severe and acute heart failure; (2) left ventricular dysfunction on echocardiography; (3) recent history of viral illness; and (4) no history of cardiomyopathy. RESULTS: Eleven children were included between 1998 and 2003, at a median age of 1 (0 to 9) year. Their mean left ventricular ejection fraction (LVEF) was 22 (SD 9)% at presentation. A virus was identified in five patients: human parvovirus B19 (n = 2), Epstein-Barr (n = 1), varicella zoster (n = 1), and coxsackie (n = 1). The median intensive care unit course was 13 (2-34) days. Intravenous inotropic support was required by nine patients and eight were mechanically ventilated. All patients received corticosteroid, associated with intravenous immunoglobulin in seven. Five patients experienced cardiocirculatory arrest that was successfully resuscitated in four. At a median follow up of 58.7 (33.8-83.1) months, the 10 survivors are asymptomatic with normalised LVEF. CONCLUSION: Despite a severe presentation, the outcome of AFM is favourable. Aggressive symptomatic management is warranted and heart transplantation should be considered only when maximal supportive therapy does not lead to improvement.

[Instrumental extraction with Thierry's spatula: 166 cases]. / Extraction instrumentale par spatules de Thierry: à propos de 166 cas.

OBJECTIVES: To describe the frequency of maternal and neonatal complications resulting from the use of Thierry's spatulas. MATERIALS AND METHODS: This retrospective study included 166 patients treated during a 17-month period. RESULTS: For 100% of the patients, the use of the spatulas allowed the extraction of the new born, in 68 cases (41%) the new born was engaged between one and two centimeters below the spines. A medio-lateral episiotomy was performed in 159 patients (96%). A serious perineal tear (Type 3) occurred for 6 of these patients (3.6%). A simple perineal tear (Type 1) or vaginal tear occurred in 24 (18%). Episiotomy was performed in 18 patients and was significantly protective. No case of serious neonatal complication were related to the use of the spatulas. CONCLUSION: We found that perineal tear rate is similar to that observed with other instruments used for fetal extraction. No case of fetal trauma could be related to the use of the spatulas; this was the goal of Thierry who creation the instrument. The use of Thierry's spatulas as a reference instrument is warranted, particularly for cases of prematurity, as these spatulas fulfil the modern obstetrics requirements of fetal protection, without maternal risk.

Prenatal prognosis of congenital diaphragmatic hernia using magnetic resonance imaging measurement of fetal lung volume.

OBJECTIVES: To investigate the correlation between fetal lung volume (FLV), measured with magnetic resonance imaging (MRI), and postnatal mortality in newborns with prenatally diagnosed isolated congenital diaphragmatic hernia (CDH). METHODS: In a 4-year prospective multicenter study, 77 fetuses with isolated CDH diagnosed between 20 and 33 weeks' gestation underwent fast spin-echo T2-weighted lung MRI. These MRI-FLV measurements were compared with a previously published normative curve obtained in 215 fetuses without thoracoabdominal malformations and with normal ultrasound biometric findings. FLV measurements were correlated with postnatal survival. The mean gestational age at MRI was 31.3 weeks. RESULTS: The measured/expected FLV ratio was significantly lower in the newborns with CDH who died compared with those who survived (23.6 +/- 12.2 vs. 36.1 +/- 13.0, P < 0.001). When the ratio was below 25%, there was a significant decrease in postnatal survival (19% vs. 40.3%, P = 0.008). Survival was significantly lower for neonates when one lung could not be seen by fetal MRI compared with those fetuses with two visible lungs on MRI (17.9% vs. 62.1%, P < 0.001). CONCLUSION: In isolated CDH, FLV measurement by MRI is a good predictor of postnatal mortality due to pulmonary hypoplasia.

[Medical emergency care units in France]. / Les maisons médicales de garde en France.

UNLABELLED: The objective of this article is to take inventory of the different medical emergency care units in France as of June 30, 2003, and to describe their main characteristics. METHODOLOGY: A telephone survey was conducted which posed questions based on a standard questionnaire to the Regional Unions of Liberal Doctors, the County Advisory Boards of the Medical Orders, and the directors and managers of the existing emergency care units. RESULTS: 97 medical safe houses were inventoried, 46 of which were operational and 51 which were in development. The Ile-de-France region is the region with the highest concentration of these units either operating or under construction. A large majority of the emergency care units were created since the year 2000, and half of them are located within health care centres and the other half into separate cells either close or distant from existing health care centres. More than half of them have no other staff aside from doctors, whilst the others comprise a spectrum of personnel including secretaries, nurses, and social assistants amongst others. More than half of the doctors are paid at the cost of each consultation and per treatment and do not have a technical platform at their disposal. Usually, these emergency care units are open all night during the week and on the weekends. One-third of them collaborate with the emergency centre and ambulance service (those who respond to calls to 15) and three-quarters of them are funded by the city's Assistance Fund for the Quality of Care. CONCLUSION: It would seem advantageous that a Charter for operation and management of these establishments be drafted and implemented in order standardise these types of structures and that their supervisors implement a national and regional follow-up mechanism for the establishments in order to better evaluate the evolution in terms of health care organisation, in particular with respect to raising the level and capacity of response.

[Results of the surgery of the truncus arteriosus: present implications]. / Résultats de la chirurgie du tronc artériel commun: implications actuelles.

We report our results of truncus arteriosus surgical reparation in a period of 10 years. From January 1993 to November 2003, 17 patients were operated with a median age and weight of 66 days and 3.5 kg respectively. According to the Van Praagh classification there were 13 cases of type A1, 2 cases of type A2 and 2 cases of A4. The connection between the right ventricle and the pulmonary artery was performed by a homograft (n = 12), a Contegra tube (n = 1) or a Barbero-Marcial intervention (n = 4). In one case, a plasty of the truncus was performed. Patients were classified in two groups: group A for those operated between 1993 and 1997 (n = 8) and group B for those operated after 1997 (n = 9). Five patients died (29%) in the post-operative period, 4 in the group A (50%) and one in group B (11%). The mean duration of intensive care stay was 12.2 (+ 7.4) days. Statistical analysis did not reveal any difference between both groups, especially concerning post-operative treatment or prognosis. In the multivariate analysis, an age below 30 days was a risk factor of post-operative death (OR = 16.5, 95% CI = 1.09 - 250; p = 0.043). After a mean follow-up of 3.9 (+ 3.5) years, 2 patients required a redo intervention for replacement of the pulmonary artery homograft. All 12 suvivors are asymptomatic without any pulmonary hypertension. In conclusion, the results of surgical reparation of the truncus arteriosus seem to improve with experience. According to recent progresses in surgery and intensive care, the intervention can be scheduled beyond the neonatal period without additive risk and with potentially less consecutive redo interventions.

[Attitude and behavior of health services users in the face of real or perceived emergencies]. / Attitudes et comportement des usagers face à une urgence réelle ou ressentie.

OBJECTIVES: To perform an opinion poll of users of normal health care, excluding emergency care, and also to identify populations which have required emergency care and to clarify the parameters which influence user decisions. METHODS: A transversal descriptive survey of users of Primary Medical Assurance Centres (Caisse Primaire d'Assurance Maladie) in the catchment area of the Hôpital Nord in Marseilles, France, on a given day (7 days in total). Data were gathered using a standardised questionnaire based on the following topics: socio-demographic profile of interviewed participants, patient attitude toward general practitioners' care, the reaction to a situation felt to be urgent and for which they resorted to emergency services. RESULTS: Interpretation of the results from 253 completed questionnaires demonstrated that users are mainly young, underprivileged, females, but who are not excluded from the health care system (good social security cover and marked presence of a family doctor). User behaviour differs according to the moment at which the problem arises (working hours, outside working hours) and depending on the degree of urgency perceived. ARISE OF DEMAND: In the most of cases, the patient consults emergency services for himself/herself. He/She takes the decision without prior consultation with a physician, within one hour of the problem arising, whether the problem is perceived as urgent or life-threatening, and arrived there under his/her own means. The main reason given is the access to emergency services without appointment and the principal medical reasons were for injuries and pain. CONCLUSION: This study demonstrates that users have a coherent approach depending on physician's consulting hours and according to user's perception of the emergency. On the other hand it is clear that users lack information concerning available after-hours care and the physicians night-duty organisation.

[The major trends of the French accreditation process. A review of the first 182 reports published]. / Les grandes tendances de l'accréditation. Bilan des 182 premiers comptes-rendus publiés.

OBJECTIVES: To reply to the following questions: what is the status of the accreditation process and what are the general trends pointed out by the experts-visitors ? METHODS: A study was conducted on the 182 accreditation reports regarding health centres, published by the Anaes from June 2000 to July 2002. A reading scale was developed and data was registered in the database. Statistical analysis first described the hospitals (legal status, location, size, number of sites, presence or lack of technical devices, emergency units, and consultations) and then matched them with the specific parameters of the accreditation process (date of involvement, date of audit, date of the accreditation deliberation, number of experts and visitors and number and type of decisions. RESULTS: The results underlined the most frequent decisions among the 10 referentials of the accreditation process. The patients' case reports and the management of quality and prevention predominated. Recent French laws and the decision of the Anaes to apply these themes in their strategic orientation can explain this. COMMENTS: The large hospital size and multi-sites organisation appeared to be negative elements and justify the apprehension felt by the 'major hospitals'.

[Factors influencing the appropriation of clinical guidelines by physicians]. / Facteurs influençant l'appropriation des recommandations médicales par les médecins.

DEFINITION: Clinical guidelines (CG) constitute a means to facilitate the decision-making process, defining what is and is not appropriate in fields concerned with public health matters or unregulated practices. METHOD: A bibliographical review has been conducted on factors likely to influence physicians' compliance to CG. These factors involve physicians, the guidelines themselves and the actions taken to encourage their implementation. FACTORS RELATED TO PHYSICIANS: In physicians' attitudes, we find not only their propensity to ask for help, to admit mistakes and weakness, but also their wish for continuing medical education. Practicing in an establishment or group consulting offices enhances their awareness of CG. The use of CG and the consequences of their implementation, as well as legal or financial concerns, increase physicians' confidence in the benefits of CG for themselves and their patients. FACTORS RELATED TO GUIDELINES: Clinical guidelines should be issued by multi-professional groups, among which there should be recognized experts and day-to-day specialists. Their access should be easy and their updating frequent. The adaptation to the individual conditions of local practices is essential. THE IMPORTANCE OF IMPLEMENTATION: Once established, an intensive dissemination and active appropriation policy should be enacted. On the other hand, it is unlikely that passively diffused and non-updated CG will be adopted by newly qualified or long-established physicians installed in routine practice. Account must also be taken of the nature of certain CG, considered restrictive or coercive, and the targeted physician's attitudes and practicing habits - which is still unusual in France.