Toward improvement of knowledge of financial conflicts of interest in a large medical school in France.

INTRODUCTION: Conflict of interests (COIs) adversely affect the integrity of science and public health. The role of medical schools in the teaching and management of COIs has been highlighted by the publication of an annual evaluation of American medical schools based on their COIs policies by the American Medical Student Association (AMSA). A deontological charter was adopted by French medical schools in 2018 but its impact on COI comprehension by students and its effects on COI prevention were not evaluated. METHODS: A 10-item direct survey was conducted among about 1000 students in Paris-Cité University in order to investigate the respect of the charter regarding COIs both in the medical school and in affiliated teaching hospitals. RESULTS: Cumulative results show a satisfying respect of prevention policies regarding COIs in the medical school and hospitals despite the fact that the existence of the charter and its major aspects were insufficiently known. Disclosure of COIs by teachers was insufficient. CONCLUSION: This first direct study among students shows better results than expected according to current non-academic surveys. Moreover, this study demonstrates the feasibility of this kind of survey whose repetition should be an appropriate tool to improve the implementation of the charter within medical schools and teaching hospitals, in particular mandatory disclosure of COIs by teachers.

[Cholangiocarcinoma: epidemiology and global management]. / Cholangiocarcinomes: épidémiologie et prise en charge globale.

SCOPE: Cholangiocarcinoma, or biliary tract tumors, are rare tumors for which survival is short, as diagnosis is often made at an advanced stage. Indeed, diagnosis remains difficult, since symptoms are often unspecific and appear at latest stages. This article presents an update of recent data and therapeutic options. CURRENT SITUATION AND SALIENT POINTS: Several etiologic factors have been identified, but for most patients, none of these factors can be found. Prognosis is often poor, and remains difficult to establish because of the lack of sufficient large-scale studies looking at the impact on preexisting tumor characteristics on overall survival. Surgery remains when possible the gold standard. When tumor removal is impossible, due to a local extension, the appropriate care of patients remains to be defined. Chemotherapy has been proposed with evidence of objective response but limited data on its ability to prolong overall survival and to enhance quality of life. Active chemotherapies appear to be made from combination of an antimetabolite, such as 5-fluorouracile or gemcitabine, and a platinum drug. PERSPECTIVES: In the near future, indications of chemotherapy could be enlarged and targeted therapy might also be used, since several molecules have been tested in preclinical studies, and be offered to patients in clinical trials.

The burden cost of French patients suffering from irritable bowel syndrome.

BACKGROUND: The impact of irritable bowel syndrome (IBS) on health-care resource use in France is evaluated, and explanatory variables determined. METHODS: A questionnaire comprising socio-demographic characteristics, symptoms, consumption of resources, quality of life and impact of IBS on productivity was administered by telephone to a sample of 253 French adults with IBS recruited from the general population, and diagnosed with IBS using several well-known diagnostic criteria. The medical costs were estimated on a monthly basis and included medication(s), physicians' consultations, investigations and hospitalizations. RESULTS: Mean age was 48.3 years and 75% of subjects were women (192). Thirty-six percent of subjects had suffered from IBS for more than 10 years; 77% had consulted a general practitioner and 43% a gastroenterologist. Twenty-nine percent of subjects had undergone an investigation and 25% reported hospitalization; 61% of patients reported that they were taking medication. The average monthly medical costs was 71.8 euros (95% CI = [57.6-86.0]) with an asymmetric distribution (median = 28.1 euros) because of a high proportion of subjects (27%) who reported receiving no care at all. The two principal cost components were investigations (39%), and hospitalizations (22%). The highest medical costs were associated with subjects who were very elderly or suffered from severe symptoms (very severe pain), and were correlated with the lowest quality of life scores. CONCLUSION: IBS has a major impact on resource consumption and the productivity of patients. Determination of the variables to explain medical costs showed that advanced age, severe pain and deterioration in quality of life could be predictive of high medical costs.

Assessment of complications of EUS-guided fine-needle aspiration.

BACKGROUND: EUS-guided fine-needle aspiration (EUS-FNA) permits both morphologic and cytologic analysis of lesions within or adjacent to the GI tract. Despite increasing use of this technique, the safety and overall complication rates remain poorly defined. METHODS: During a period of 20 months, 322 consecutive patients underwent EUS-FNA in 2 centers. All procedures were performed with the patients under general anesthesia. All complications (including local complications resulting from endoscopy/aspiration or clinical complications after the procedure) were evaluated. Potential risk factors for the development of complications were also analyzed including site and nature of the lesion, presence of portal hypertension, and number of needle passes. RESULTS: A total of 345 lesions were aspirated in 322 patients. EUS-FNA involved the pancreas in 248 cases. Pancreatic lesions included solid (134) and cystic (114) types, which required a mean of 2.5 and 1.4 needle passes, respectively. Complications were observed in 4 (1.2%) patients after aspiration of pancreatic cystic lesions (acute pancreatitis, n = 3; aspiration pneumonia, n = 1) and all cases of pancreatitis resulted from FNA of lesions in the head/uncinate process. No complications resulted from FNA of solid pancreatic lesions. Complications were not observed after FNA of lymph nodes (n = 62) and one case of aspiration pneumonia was observed after FNA of a stromal tumor. EUS-FNA was performed without complication in 16 patients (5%) with portal hypertension. The number of needle passes was not predictive of complications. CONCLUSIONS: Because the overall risk of complications from EUS-FNA was relatively low (1.6%) with no severe or fatal incidents and although the risk appears slightly higher than that for standard EUS alone, the safety of EUS-FNA appears acceptable based on this analysis from an experienced center.

Intraductal papillary mucinous tumors of the pancreas: pancreatic resections guided by preoperative morphological assessment and intraoperative frozen section examination.

BACKGROUND: We undertook this study to assess the results of a policy of limited pancreatic resections for intraductal papillary-mucinous tumors (IPMT), guided by a standardized preoperative morphological assessment and the frozen section histologic examination of pancreatic resection margins. METHODS: From 1991 to 1998, there were 41 patients who underwent resection of IPMT in our center after standardized morphological preoperative assessment, including abdominal computed tomography scans, endoscopic retrograde cholangiopancreatography, and endoscopic ultrasonography. All patients but one underwent a partial pancreatic resection. RESULTS: Preoperative assessment had an 89% diagnostic accuracy for IPMT. It detected malignant transformation with a 67% sensitivity and a 95% specificity, but failed to correctly assess ductal extension of the disease in 17 cases (41%). The diagnostic accuracy of frozen section histologic examination of the pancreatic resection margin was 92%. There was no recurrence in case of in situ carcinoma when epithelial lesions were completely resected (8 cases) nor in lower grades of dysplasia (23 cases). Conversely, recurrence was constant in invasive carcinoma (10 cases) regardless of the status of the pancreatic margin. CONCLUSIONS: Frozen section histologic examination of the pancreatic resection margin is useful and reliable to ensure a complete resection of IPMT by a partial resection that prevents recurrence of noninvasive lesions.

Is Helicobacter pylori eradication a cost-effective treatment of duodenal ulcer disease?

Treatment strategies aimed at eradicating Helicobacter pylori have shown positive results in the management of duodenal ulcer disease. Several cost-effectiveness studies comparing these regimens with traditional therapy have recently been conducted, and results are discussed in this review. Cost comparisons of different treatment strategies cannot be performed without first identifying whether the cost of ulcer diagnosis is included in the study. Assuming that only 20% of patients with dyspepsia actually have ulcer disease, costs may vary, depending on the study population. Importantly, treatment costs should not be compared between a patient population with confirmed ulcer disease and one without confirmed disease. In patients with confirmed ulcer disease, studies consistently show that H. pylori eradication strategies are associated with greater efficacy and lower costs than traditional treatment, and are therefore a more cost-effective alternative to standard therapy. Although all models used in the cost-effectiveness analyses assume that patients discontinue treatment following successful eradication of the microorganism, in clinical practice some patients continue antisecretory treatment beyond this period. Thus, savings as a result of H. pylori eradication may be less substantial than indicated in cost-effectiveness studies.

Pharmaco-economic considerations in the long-term management of peptic ulcer disease.

Pharmaco-economic consequences of available therapeutic strategies in the management of duodenal ulcer disease are of increasing importance. Terminology and methodology in economic evaluation need to be clarified: direct and indirect costs of duodenal ulcer disease have to be calculated, and results expressed in terms of efficacy, utility or benefits. The economic analysis then compares costs or cost-effectiveness ratios of various strategies. Macro-economic evaluations conducted in France have shown that the overall cost of duodenal ulcer disease was FF 3.5 billion in 1987 in private practice. Several evaluations have shown that indirect costs accounted for more than 50% of the total expense. From a microeconomic point of view, several studies have been conducted with ranitidine and cimetidine. Our own study has shown that one year of treatment with ranitidine 150 mg/day resulted in a decrease in the use of medical resources (clinic visits, endoscopic investigations, duration of hospital stay) and work days lost, when compared with placebo. This resulted in a smaller cost of the ranitidine strategy (FF 2031 per patient for one year for the community, vs. FF 2823 for the placebo strategy). Similar cost-effectiveness ratios for the ranitidine strategy have been shown in the USA. Costs savings have also been demonstrated during long-term treatment with cimetidine for up to 3 years. Studies performed according to Markov's chain model have shown that the costs of continuous and intermittent treatments are identical, the expenses related to investigations and mortality being greater with the latter. More studies are warranted to evaluate the efficiency of the different strategies used in the treatment of duodenal ulcer disease.(ABSTRACT TRUNCATED AT 250 WORDS)

[Cost of fibroscopy in gastroduodenal ulcer]. / Coût de la fibroscopie dans la maladie ulcéreuse gastroduodénale.

The assessment of mean cost of upper GI endoscopy is of critical importance if one wants to perform pharmacoeconomic studies, especially in peptic ulcer disease (PUD). The aim of this work was to calculate such costs, based on an inquiry conducted in December 1991 in a representative sampling of 94 French gastroenterologists (GEs) (i.e. 4.3% of the whole population). Thirty-nine percent of GEs work in their office; 25% work in private and 26% in public hospitals. GEs performed 70 +/- 5 (mean +/- SEM) upper GI endoscopies per month. Fifty-nine % are performed to investigate epigastric pain; PUD was found in nearly one patient out of four. Fifteen % of the endoscopies were performed for follow-up of PUD. Upper GI endoscopy modalities varied greatly according to whether performed in GEs' office, private or public hospital. The proportion of investigations performed with biopsies was 66, 71 and 50%, respectively. Neuroleptanalgesia (or general anesthesia), was performed in 8, 49 and 4% of cases, respectively, and a 24-hour hospitalization was required in 0, 7 and 2% of cases, respectively. Sources of expenditure were evaluated according to the current fares of the French Health Care System (for GEs' office and private hospitals) and to real costs (for public hospitals). Taking into account the differences in place and modalities of realization, mean cost of upper GI endoscopy was evaluated at 1,084 FF. This cost could be used in future cost or cost/effectiveness studies of diagnostic or therapeutic strategies.

[Economic analysis of maintenance treatment with ranitidine 150 mg in duodenal ulcer]. / Analyse économique du traitement d'entretien de la maladie ulcéreuse duodénale par la ranitidine 150 mg. Groupe d'Etude de la Maladie Ulcéreuse Duodénale (GEMUD).

While it is well-established that ranitidine 150 mg/day is effective in preventing recurrence and complications of duodenal ulcer, the economic impact of maintenance therapy is unknown. Socio-economic data, allowing to calculate the costs and cost-effectiveness ratio of intermittent and maintenance therapy, were prospectively obtained from a therapeutic trial in 399 duodenal ulcer patients (Mignon et al, Gastroenterol Clin Biol 1990;14:732-8). Visits and endoscopy investigations, work days lost, duration of hospital stay and drug consumption were recorded in both placebo (n = 202) and ranitidine (n = 197) groups. Each source of expenditure was evaluated using current fares and sales prices, from the point of view of both the collectivity and the French Health Care System. The costs of ranitidine strategy were less than the costs of placebo strategy, for the collectivity (2,031 and 2,823 FF per patient for one year, respectively) as well as for the French Health Care System (1,541 and 2,426 FF per patient per year, respectively). In the ranitidine group, expenditures were principally due to the drug (71%) and endoscopy investigation (24%). In the placebo group, endoscopy and hospital stay accounted for 50 and 39% of the expenses, respectively. The latter were due to the occurrence of complications in the placebo group. Sensitivity analysis disclosed that the results were unsensitive to the variations in cost hypotheses of the main expenditure sources. Cost/effectiveness analysis defined as cost per patient successfully treated showed that the cost of a "ranitidine strategy" was 2-3 times less than a "placebo strategy". Maintenance therapy for duodenal ulcer with ranitidine 150 mg/day for one year is less expensive and more cost-effective than intermittent treatment.