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A Vergnenègre

Publications and source records attributed to A Vergnenègre.

At least 19 recordsLinked to original sources

[Cost-effectiveness analysis: a reader's guide].

INTRODUCTION: This article is devoted to the critical appraisal of cost-effectiveness analysis. METHODS: The example chosen concerns the choice of first line chemotherapy for a patient with stage IV non small cell bronchial carcinoma; a common problem in thoracic oncology. It compares three chemotherapy regimes: vinorelbine alone, cisplatin-vinorelbine and cisplatin-vindesine. PERSPECTIVES: The guide used allows evaluation of the validity of the methodology and, therefore, of the results obtained. CONCLUSION: The article studies the possible application of these results to the patient whose clinical history was presented as an introduction. The limitations of cost-effectiveness analyses are also considered.

Antineoplastic Agents↗

Phase II randomized multicenter study evaluating a treatment regimen alternating docetaxel and cisplatin-vinorelbine with a cisplatin-vinorelbine control group in patients with stage IV non-small-cell lung cancer: GFPC 97.01 study.

BACKGROUND: The potential absence of cross-resistance between cisplatin and docetaxel in non-small-cell lung cancer (NSCLC) suggests that alternating regimens of cisplatin-based chemotherapy and docetaxel might increase the activity of chemotherapy in stage IV NSCLC. PATIENTS AND METHODS: Randomized, multicenter, non-comparative phase II study in patients with stage IV NSCLC (Eastern Cooperative Oncology Group performance status of 0-2). Patients randomized to alternating treatment group (A) received docetaxel 100 mg/m2 on days (D) 1 and 43 alternating with cisplatin 100 mg/m2 on D22 and vinorelbine 30 mg/m2 on D22, D29 and D36. Those randomized to the control group (B) received cisplatin 80 mg/m2 on D1, D22 and D43 and vinorelbine 30 mg/m2 once a week from D1 to D57. Treatment was continued for a further 6 weeks in the event of objective response or stabilization. RESULTS: Seventy patients were enrolled (group A: 38, group B: 32). More premature treatment discontinuations due to toxicity were observed in group A (median number of cycles: 3) than in group B (median number of cycles: 5). The intention-to-treat objective response rate was 10.8% [95% confidence interval (CI) 0.8% to 20.8%] in group A compared with 25% (95% CI 10% to 40%) in group B, the median time to treatment failure being 10.2 weeks and 17.3 weeks, respectively. The median survival and 1-year survival were 29.1 weeks and 39% in group A compared with 41.6 weeks and 42% in group B. Febrile neutropenia occurred in 5.9 and 4.9% of the cycles in group A and group B, respectively. Non-hematological toxicity was moderate in the two groups. CONCLUSIONS: The addition of docetaxel alternating with cisplatin-vinorelbine did not enhance the activity of this combination. The development of sequential regimens might be a more promising way of exploiting the absence of cross-resistance between these two drugs.

Adult↗

Chronic bronchitis among French adults: high prevalence and underdiagnosis.

The aims of this survey were to determine the prevalence of symptoms indicative of chronic bronchitis (CB) in the French adult population, to identify the role of risk factors for CB, and to assess rates of CB diagnosis and pulmonary function testing (PFT) in the presence of CB. A representative sample of 14,076 individuals aged > or = 25 yrs completed a self-administered questionnaire on symptoms, comorbidities, smoking history, sociodemographical data, and diagnosis and care by physicians. The prevalence of CB was 4.1% and the prevalence of chronic cough and/or expectoration was 11.7%. In individuals with comorbidity, these figures were 10.4% and 24.4%, respectively. Smoking was associated with an increased frequency of CB. In subjects with CB, 44.6% had PFT (spirometry or peak expiratory flow measurement), 24% were diagnosed as having CB, and 7.2% received care. Rates of diagnosis, PFT, and follow-up were lower in young individuals and in those without comorbidity. PFT and follow-up were less common in current smokers. Prevalence of chronic bronchitis in French adults is high and similar in magnitude to that of other industrialised countries. Comorbidities and tobacco smoking increase the frequency of chronic bronchitis symptoms. Chronic bronchitis is too infrequently diagnosed, investigated and cared for.

Adult↗

Variability of ankle-arm index in general population according to its mode of calculation.

BACKGROUND: Ankle-arm index (AAI) is commonly used in epidemiological studies on peripheral arterial disease but its mode of calculation varies throughout the literature. We aimed to study the variance of the different measurements required to calculate the AAI according to different formulas, in order to find out the best way of AAI calculation, based on its lesser variability. METHODS: A sample of 222 subjects from the general population was prospectively studied. Ten persons were excluded because of the presence of intermittent claudication or due to a lack of a Doppler posterior tibial artery (PT) signal. The systolic pressures of both arms, the dorsalis pedis arteries (DP) and the PT were finally measured in 212 healthy persons (mean age 49.9, range 18-101). RESULTS: Methods using the lowest ankle artery pressure were excluded, as an absent pedal pulse may not be abnormal. The mode using the lowest variance was the choice of the highest pressure between PT and DP of each leg divided by the mean of the systolic pressures of both arms. CONCLUSIONS: We recommend this mode of AAI calculation in epidemiological studies. As the variances of the measurements used are the lowest, it would be easier thereafter to determine normal ranges and cutoff points.

Adolescent↗

[Quality of medical records in the "Medical Information System Program": application of the lot quality assurance sampling method].

BACKGROUND: The aim of this study was to validate a new method of quality control of medical records of the "Medicalisation of Information System Program" (P.M.S.I.) in Limoges university hospital. METHODS: Lot quality assurance sampling (L.Q.A.S.), developed to meet industrial quality control needs, has been applied. This method allows to give an opinion on the quality of a lot from a sample randomised in this lot. Ten hospital units have been randomised. During three months, these medical units have recoded ten medical units abstracts (R.U.M.) which were randomised each month within their stays. If five or more R.U.M. had been modified on Principal Diagnosis (D.P.), Associated Significant Diagnosis (D.A.S.) or Diagnosis Related Group (D.R.G.), the lot was rejected. The hospital unit had then less 70% R.U.M. of good quality (alpha=5%). The global errors rates were compared to the results of usually performed quality control (1998). RESULTS: Nine hospital units were included. Hospital units which already had a low quality rate during the 1998 quality control had also an insufficient quality by L.Q.A.S. method. Among these, 33.7 [CI(95%): 21.6-45.8] R.U.M. have been modified. Medical units had a poorer data quality than surgical ones. No statistically significant difference was shown between 1998 errors rates and L.Q.A.S. rates, except for D.P. (p=0.002). CONCLUSION: L.Q.A.S. is easy to apply, could be repeated more frequently than usual controls, and allows to detect hospital units which require a faster action. This process could be applied to P.M.S.I., in which the search of quality is necessary because of the new cost model which includes secondary D.R.G.

Abstracting and Indexing↗

Economic analyses and lung cancer.

The economic assessment of treatments or medical strategies has been the subject of an increasing number of publications. The elevated costs and relative lack of efficacy of many treatments of chronic diseases such as lung cancer are an added impetus to such analyses. In the first part of this review, we summarise the theoretical basis of economic assessment, the tools available and the limitations of these methods. In the second part, we examine their application to the treatment of lung cancer. We discuss the evaluation of the cost of these cancers to society, economic assessment of new chemotherapeutic drugs, and the place of cost-effectiveness analysis in randomized trials. In the last part, we outline the interest and future of such considerations for clinicians. These methods, which provide complementary data for clinicians when making decisions on therapeutic options, will be adopted more widely in coming years.

Canada↗

[Evaluation of respiratory intensive care units at pneumology services].

Audits should be conducted in respiratory intensive care units (ICU) as in all other ICU using patient-specific indicators to assess medical activity and quality of care. However, other criteria, such as those developed by the SRLF ("Société de Réanimation de Langue Française"), should also be used. These criteria include the description of the patients previous health status, prognosis of underlying diseases, the SAPS I or SAPS II severity score at admission, the omega or TISS therapeutic scores, and the PRN index of health care burden. Medial and administrative audits are conducted using diagnosis-related groups (DRG) and case mix classification. The DRGs are used to establish an aggregate index of activity (ISA points) which contribute to the complex mechanism of budget allowance. Unfortunately, the French DRG case mix system does not provide an appropriate description of the costs of ICU stays. One of the special features of respiratory ICUs is related to patient flow. Patients are referred from a respiratory unit and discharged to a respiratory unit or a respiratory rehabilitation center. Readmissions are frequent. Many patients are also admitted only for diagnosis or a respiratory procedure requiring close surveillance. The SRLF criteria, which take into consideration all of these features, should always be used for the evaluation of quality of care. The French Society of Lung Disease (SPLF) has proposed specific standards of quality for respiratory ICU. We present here examples issuing for the ICU of the Hôtel-Dieu Hospital in Paris. The results show that non-specific national indicators, in combination with other indicators specific for respiratory ICU, provide appropriate audit data.

France↗

[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology].

PURPOSE: Determine the response to, and toxicity of docetaxel (Taxotere) in patients (pts) with inoperable non-small-cell lung cancer (NSCLC) previously treated with platinum-containing chemotherapy. PATIENTS AND METHODS: Twenty-seven patients with stage IIIB or IV NSCLC, having received one platinum-containing regimen were treated with 100 mg/m2/3 weeks of docetaxel until tumor progression or severe toxicity. Premedication with prednisolone and diosmin was given in all patients. Antitumoral activity was assessable in 21/27 pts. Median age: 52 years; WHO performance status 0-1: 77% pts, stage IV disease: 63% pts. RESULTS: 6/21 eligible pts (24%) achieved a partial response to treatment [C.I 95%: 5.6-42]. Median time to progression: 2.9 months, median survival: 8.5 months with a median follow-up of 23.7 months (range: 13.5-27). Hematologic toxicity: grade 3-4 neutropenia: 75% pts, febrile neutropenia: 11% cycles. Non hematologic toxicities: fluid retention, rash, alopecia, sensory neuropathy, asthenia, and nail changes. CONCLUSION: Docetaxel (Taxotere) administered at 100 mg/m2/3 weeks has relevant clinical activity against platinum treated NSCLC pts. Neutropenia is the main toxicity.

Adenocarcinoma↗

[French translation and validation of the Edinburgh Questionnaire for the diagnosis of intermittent claudication].

Obliterative arterial disease of the lower limbs is diagnosed by simple, reproducible, sensitive and non-invasive methods. One of these, a questionnaire for the diagnosis on intermittent limping, is a method of choice. Until recent years, the only validated questionnaire was the one proposed by the World Health Organisation. This was criticised a lot, especially for its lack of sensitivity. Recently, a Scottish group proposed an improvement in the diagnostic performance of this questionnaire by carrying out several changes. This new version, called the Edinburgh Questionnaire, has promising diagnostic qualities. The authors present a French version of this questionnaire. This French translation was validated in 105 patients referred for diagnosis of obliterative lower limb arterial disease. A sensitivity of 86.5%, a specificity of 95.6%, a positive predictive value of 91.4% and a negative predictive value of 92.9% of this French version are comparable to the results obtained with the English version. Therefore, the authors suggest using this questionnaire in epidemiological and public health studies in France.

Aged↗

[Radon and domestic exposure].

Radon is a noble gas derived from the decay of radium, which itself is a decay product of uranium. The decay products of radon can collect electrostatically on dust particles in the air and, if these particles are inhaled and attach to bronchial epithelium, produce a high local radiation dose. Alpha particles can induce DNA double-strand breaks and the development of cancer. A causal relation between lung cancer and radon exposure and its progeny has been demonstrated in epidemiological studies of miners. Radon exposure became a public health issue almost 15 years ago. Most radon exposure occurs indoors, predominantly in the home. There is however, a wide range of radon concentration values in different countries. The highest level occurs in areas with granite and permeable soils. The risk for smoking, the leading cause of lung cancer, is far greater than for radon, the second leading cause. The estimates obtained from case-control studies of indoor radon are very contradictory. Scientific knowledge of effects of low levels of exposure to radon and the role of cigarette smoking, as a combined factor, must be studied. Smoking and radon probably interact in a multiplicative fashion.

Air Movements↗

The cost-effectiveness of paclitaxel (Taxol) + cisplatin is similar to that of teniposide + cisplatin in advanced non-small cell lung cancer: a multicountry analysis.

A large randomized clinical trial in advanced, previously untreated, non-small cell lung cancer (NSCLC) patients revealed better response rates and better tolerance for paclitaxel+cisplatin (TAXCIS) compared to teniposide+cisplatin (TENCIS). Since economic evidence is receiving increasing attention in health care, we conducted an economic evaluation based on the trial results in The Netherlands, Belgium, France and Spain. The evaluation was based on (i) differences in drug costs, (ii) differences in chemotherapy administration and (iii) the economic consequences of significantly different clinical outcomes in the trial: anemia, thrombocytopenia, neutropenia, neuropathy and arthralgia/myalgia. Data regarding medical resource utilization were obtained from clinician interviews using a Delphi technique and validated by patient charts analysis. Differences in medical management occurred across countries, but TAXCIS was cost-additive in all countries, i.e. the extra cost of chemotherapy was only partially compensated by savings in medical resource use, resulting in a net cost per patient of US$2311. In the trial, TAXCIS therapy produced a 37% response rate compared to 26% for TENCIS. The cost per extra responder for TAXCIS is on average US$21011, which is comparable to the cost per responder obtained with TENCIS (US$27266). Thus, the cost-effectiveness of TAXCIS, expressed in cost per responder, is similar to the cost-effectiveness obtained with TENCIS.

Antineoplastic Agents↗

[Interventional radiology and the medical applications of information systems: what consequences for the radiology department?].

The French health care system reform has introduced some changes in the distribution of hospital budgets according to the distribution of admitted patients in diagnosis related groups (DRGs). This new model of budget allocation does not take into account the more technical nature of some medical procedures and services and does not promote the implementation of new technologies. Using four simulated clinical cases, we studied the length of stay in different DRGs and the number of associated points (points d'indice synthétique d'activité, ISA). The addition of the interventional radiologic procedures did not modify the DRG (which remained unchanged from the initial DRG). In order to achieve recognition of the specific nature of interventional radiology procedures, a database should be created and an economical evaluation conducted.

Age Factors↗

[High-dose ifosfamide in patients with stage IV non-small cell lung cancer: phase II trial from the Groupe français de pneumo-cancérologie (GFPC)].

PURPOSE: To assess the toxicity and efficacy of high dose ifosfamide in stage IV NSCLC. METHODS: In a previous trial, we have determined maximum tolerated dose for 3-days ifosfamide treatment by 3-weeks schedule as 9 g/m2 according to hematologic tolerance. We therefore set up a phase II to study the toxicity and efficacy of this schedule in chemotherapy naive metastatic NSCLC. Ifosfamide (+ mesna 1 g/m2) was administered by a two hour infusion (3 g/m2) for three days every three weeks. Patients received three mesna bolus infusions (1 g/m2) at 4, 8 and 12 hours after the end of ifosfamide infusion. Antitumoral efficacy was performed after 2 cycles and treatment could be pursued for responding patients until disease progression. From september 1995 to January 1997, 31 patients have been included in this study. Median age was 60.7 years +/- 1.33 (41-70) for 27 males and 4 females. Patients (pts) presented metastases in lung for 10 pts, bone for 10 pts, liver for 6 pts, adrenal for 4 pts and multiorgan metastatic localisation for 1 patient. Seven patients were unassessable: 1 lost for follow-up, 1 sudden death, 5 treatment interruptions before evaluation time and 3 toxic deaths (9.6%). TOXICITY: neutropenia grade 4 (10 pts and 1 death), cardiotoxicity grade 4 (1 pt) and 2 deaths following neurotoxicity grade 4. We achieve 4 partial responses (13%, 95CI: 3.6-29.8), 10 progressive diseases (32.3%, 95CI: 16.7-51.4) and 10 stabilizations (32.3%, 95CI: 16.7-51.4). Median response duration was 91 days +/- 55 d. Median survival was 9.3 months, e.g. 280 days (8-863). Overall survival at one year is 48%. CONCLUSION: This modality of high dose ifosfamide is as effective as standard monotherapy schedules in stage IV NSCLC. Unexpected toxicities particularly hematological ones could be due to a short duration of fractionated treatment. Results in term of survival leads us to further evaluate ifosfamide monotherapy treatment on a 5-day schedule basis.

Adult↗

[Methodology for assessing continuing medical education at the first united French congress of pneumology].

The evaluation of continuing medical education (CME) courses will soon become one of the tools used to assess post-graduate training, particularly in compliance with the recent legislation. In 1997, the organization committee of the French congress of pneumology decided to analyze the different methodologies used to assess the congress CME courses. The analysis was based on a satisfaction questionnaire, a before-after assessment of 4 workshops, and a comparison between participants and non-participants in 3 plenary sessions. Mann-Whitney and Wilcoxon non-parametric tests were used for statistical analysis. Satisfaction scores were high. For the plenary sessions, test results were better for participants than for the non-participant controls and for the workshops, test results were higher after completion. This type of study can only evaluate the level of knowledge acquired and is subject to a selection bias. It cannot analyze the practical impact of the courses nor their effect on patient health. Such assessment methodologies should be used more widely in order to improve future training sessions.

Education, Medical, Continuing↗

Airway obstruction and rheumatoid arthritis.

The aim of this study was to assess the percentage of respiratory disorders and airway obstruction in patients with rheumatoid arthritis by comparing lung function test results between patients with rheumatoid arthritis and control subjects with other rheumatological conditions. A prospective case-control study of respiratory symptoms and lung function abnormalities was performed in a series of 100 patients with rheumatoid arthritis. Eighty eight patients with other rheumatological diseases served as controls. Diagnosis of respiratory disorders was based on clinical, radiological and spirometric findings. Airway obstruction was determined from predicted values. The results were compared using Student's t-test and Chi-squared tests. An explanatory analysis was carried out by linear regression. The number of symptoms, respiratory disorders (including bronchiectasis) and lung function abnormalities was higher in patients with rheumatoid arthritis than in controls. After exclusion of smokers, the proportion of airway obstruction in patients with rheumatoid arthritis was 16% (versus 0% in controls), although the patients with rheumatoid arthritis still had more symptoms and respiratory disorders. The Chi-squared test did not identify any relationship between airway obstruction, duration of rheumatoid arthritis and type of treatment and occurrence of Sjögren's syndrome. In the nonsmokers, different explanatory models for the patients with and without a history of cardiac and respiratory disease emerged from multivariate analysis of indices of obstruction. These models included variables characterizing the severity and course of the rheumatoid arthritis. Respiratory disorders (including bronchiectasis) and airway obstruction are more frequent among patients with rheumatoid arthritis than in rheumatological controls. Although the exact pathophysiology of the link between bronchial obstruction and rheumatoid arthritis is still a matter of debate, explanatory factors for obstruction included variables characterizing the rheumatoid arthritis.

Adult↗

Cost analysis of hospital treatment--two chemotherapic regimens for non-surgical non-small cell lung cancer. GFPC (Groupe Français Pneumo Cancérologie)

STUDY OBJECTIVES: compare the costs of two regimens of chemotherapy. Apply weighted costs to an economic model in a hospital perspective. DESIGN: prospective randomized study of two groups of patients receiving: branch B, mitomycin-navelbine-cisplatin (MNP); branch A, mitomycin-vindesine-cisplatin (MVP). SETTING: pneumologic units of University and non-University hospitals. METHODS: clinical evaluation during chemotherapy incorporated events enabling construction of an event tree. Direct hospital costs included those of: cytostatic agents, materials used and nursing time; costs of side-effects (medical and paramedical time, diagnostic and therapeutic examinations). Effectiveness was measured in terms of response rates. PATIENTS: 209 patients were included, 100 in arm B, 109 in arm A. RESULTS: the response rates were 25% in branch B, 17% in branch A. In the hypothesis of equivalence of the two strategies, we compared only overall mean cost per patient. Despite the fact arm B needed more hospital injections, the difference was low (+4.6%). For a difference in effectiveness, the opposite was observed for the average cost-effectiveness ratio: arm B was less costly (-12 339.40 FF for a responder). CONCLUSION: incorporation of economic parameters was found to have a bearing on the choice of chemotherapeutic regimen for the treatment of non-small cell lung cancer. Economic analyses of this kind can provide useful extra information for rational therapeutic decisions.

Adult↗

Multicenter randomized trial comparing cisplatin-mitomycin-vinorelbine versus cisplatin-mitomycin-vindesine in advanced non-small cell lung cancer. 'Groupe Français de Pneumo-Cancérologie'.

The study was designed to evaluate the value of vinorelbine in a cisplatin-mitomycin-vinca alkaloid regimen for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). A group of 227 patients with inoperable NSCLC in stage III (58%) or stage IV (42%) were included in this randomized multicenter trial comparing a reference regimen (VDS group, n = 113) cisplatin (120 mg/m2 on day 1, day 29 and day 71), mitomycin (8 mg/m2 on day 1, day 29 and day 71) and vindesine (3 mg/m2/week for 5 weeks and then every 2 weeks up to the 15th week) to a cisplatin-mitomycin-vinorelbine combination (VNB group, n = 114), with cisplatin and mitomycin at the same doses, and vinorelbine 25 mg/m2/week for 16 weeks. The objective response rate (evaluated at 17th week) was 17% in the VDS group and 25% in the VNB group (P = 0.15). Median survival was 33.4 weeks and 34.5 weeks in the VDS and VNB arms, respectively. Overall survival duration was not significantly different between the two arms (logrank test, P = 0.20) despite a trend to an increased survival in the VNB group. This essentially benefited the patients with stage III disease with a clear-cut lengthening of median (45.9 vs. 33.4 weeks) and 1 year survival (44.6% vs. 26.2%, P < 0.05) in favor of the VNB group. Nevertheless, there was no significant difference in overall survival (logrank, P = 0.13). Survival duration of the patients with stage IV disease was comparable in the two arms (logrank test, P = 0.90). Grade 3 or 4 neutropenia was found in 61% and 87% of the VDS and VNB groups, respectively (P < 0.01). Grade 2-4 peripheral neuropathy was observed in 23% of the patients in the VDS group and in 6% of the patients in the VNB group (P < 0.01). Replacement of vindesine by vinorelbine in a cisplatin-mitomycin-vinca alkaloid chemotherapeutic regimen did not lead to a significant improvement in objective response rate or in duration of survival. There was a reduction in neurotoxicity at the expense of an increased hematologic toxicity. However, for patients with stage III disease there was an increase in 1 year survival with the vinorelbine combination.

Aged↗

Antioxidant activity in bronchoalveolar lavage fluid from patients with lung cancer.

Glutathione (GSH) is one of the key components of the lung antioxidant defenses. Chronic smokers have higher GSH concentrations in their epithelial lining fluid than do nonsmokers. The aim of this study was to compare antioxidant concentrations in epithelial lining fluid (ELF) from nonsmokers, smokers with, and smokers without non-small-cell lung cancer. The study found that GSH in ELF from patients with lung cancer was significantly greater than in ELF from smokers and nonsmokers, at 1,485.5 +/- 208, 544 +/- 97.6 microM, and 339.3 +/- 112 microM, respectively (p < 0.05). In contrast, superoxide dismutase (SOD) was lower in ELF from patients with lung cancer than in that from smokers and nonsmokers, at 3.52 +/- 0.99, 30.82 +/- 8.2, and 43.91 +/- 10.1 U/ml, respectively (p < 0.05). Spontaneous superoxide anion release by adherent alveolar macrophages (AM) showed no difference between smokers with and without lung cancer. These data indicate that patients with lung cancer have marked modifications in their ELF antioxidant defenses by comparison with those of smokers. It is difficult to distinguish whether changed antioxidant status is a primary disturbance involved in the cancer process or whether it is a consequence of the neoplastic changes in malignancy.

Adult↗