Country profile. France.
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Delivery of Health Care↗
Biomedical subjects
H Maisonneuve
Publications and source records attributed to H Maisonneuve.
[The absence of style is the best style in medical writing].
The author describes his conception of medical writing. Based upon a critical analysis of articles recently published in the Archives de Pédiatrie, he underlines the main principles which have to be respected for the writing of a medical article. This paper will be completed in an article entitled "The different redactional forms in medicine" to be published in the next issue (January 1988) of the journal.
Publishing↗
Misleading information on environmental tobacco smoke in the French lay press.
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Advertising↗
The French clinical guidelines and medical references programme: development of 48 guidelines for private practice over a period of 18 months.
The French medical profession and health insurance organizations have jointly committed themselves to a concept termed the 'medical regulation' of care. They decided to promote the quality of health care, judging that an approach based on quality was the best option for reducing the increase in health costs. The Clinical Guidelines and Medical References programme was entrusted to ANDEM (Agence Nationale pour le Développement de L'Evaluation Médicale). Fifty working groups (669 experts) and 50 reading groups (1643 experts) met from June 1994 to November 1995 to produce guidelines. Learned societies were involved to propose experts. Hospital practitioners, doctors who specialized in the topic in question and those who did not had equal representation in the groups. The method consisted of a review of the literature to determine the level of scientific evidence. ANDEM's Scientific Council suggested modifications to the groups and agreed to disseminate 48 of the 50 texts. Careful observation of the operation of the groups identified factors that can positively influence the nature of the discussions and help avoid conflict: an abundance of high-quality literature, an understanding of clinical research methodology, the existence of guidelines from different institutions or different countries tending towards the same conclusions, good initial work carried out by the chairperson and the project manager, a limit to the number of questions asked of the group, the chairperson having good people skills and meeting-management skills, and an absence of professional and financial consequences for the participants. Good management of working groups is an additional factor in ensuring success. The regulatory medical references programme has led to changes of behaviour within the medical profession.
Consensus Statements as Topic↗
Is the International Prognostic Index for aggressive lymphomas useful for low-grade lymphoma patients? Applicability to stage III-IV patients. The GOELAMS Group, France.
BACKGROUND: The International Prognostic Index (IPI) is widely used to predict outcome of patients with aggressive lymphomas. Our goal was to assess the prognostic value of this index for low-grade lymphoma. PATIENTS AND METHODS: One hundred eighty-two patients with disseminated (stage III or IV) low-grade lymphoma were enrolled in a prospective multicenter trial. According to the initial features, treatment either was started immediately or was deferred until indicated by disease progression. Patients received the same polychemotherapy regimen, given monthly for six cycles. They were assigned to one of four risk groups according to the number of presenting risk factors: low-risk (0 or 1), low-intermediate-risk (2), high-intermediate-risk (3), high-risk groups (4). RESULTS: Survival curves (Kaplan-Meier method) demonstrated a high significant difference for the four groups (log-rank: P < 0.0001). Median survival for the low-risk group has yet to be reached, while that for the three other groups are, respectively, 65, 34, and 12 months. CONCLUSIONS: In this study, the IPI has been found to be an important prognostic tool in low-grade lymphoma and may be used in the selection of appropriate therapeutic approaches for individual patients.
Humans↗
French regulatory medical references are criteria, not clinical guidelines.
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Drug Prescriptions↗
Misconduct in research. Misconduct is not reported in biomedical journals in France.
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Biomedical Research↗
A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome.
BACKGROUND: The median survival of patients with myeloma after conventional chemotherapy is three years or less. Promising results have been reported with high-dose therapy supported by autologous bone marrow transplantation. We conducted a randomized study comparing conventional chemotherapy and high-dose therapy. METHODS: Two hundred previously untreated patients under the age of 65 years who had myeloma were randomly assigned at the time of diagnosis to receive either conventional chemotherapy or high-dose therapy and autologous bone marrow transplantation. RESULTS: The response rate among the patients who received high-dose therapy was 81 percent (including complete responses in 22 percent and very good partial responses in 16 percent), whereas it was 57 percent (complete responses in 5 percent and very good partial responses in 9 percent) in the group treated with conventional chemotherapy (P < 0.001). The probability of event-free survival for five years was 28 percent in the high-dose group and 10 percent in the conventional-dose group (P = 0.01); the overall estimated rate of survival for five years was 52 percent in the high-dose group and 12 percent in the conventional-dose group (P = 0.03). Treatment-related mortality was similar in the two groups. CONCLUSIONS: High-dose therapy combined with transplantation improves the response rate, eventfree survival, and overall survival in patients with myeloma.
Adult↗
[Good practice is a means for preventing fraud in clinical research].
The aim of this article is to present the findings concerning scientific fraud that have appeared in case reports. Deliberate scientific fraud does exist. The fact that most of the documented cases have occurred in Anglo-Saxon countries seems to indicate, not that Anglo-Saxons are more prone to scientific fraud, but rather that they have been more successful in bringing it to light. Since 1974, 72 cases have been reported in which there was either conclusive evidence or else a strong presumption of fraud: one case in Switzerland, one in Canada, four in Australia, 14 in Great Britain and 52 in the United States. Fraud is estimated to affect 2-5% of clinical research trials. Referees and readers do not set out to track fraud. The American Commission has proposed the terms "misappropriation, interference, misrepresentation" to define fraud. Voluntary fraud is hidden and its detection delayed. In well-known cases, more than 5 years elapsed before the information reached the scientific community. Whistle blowers must sustain a determined effort to denounce fraud over a period of 1-3 years if they are to trigger an investigation. Some whistle blowers have themselves been accused of fraud because their claims proved so embarrassing. Fraud can lead to severe accidents and generate expenditure that those responsible, or the institutions they work for, will never pay back. Frauders are usually motivated by the desire for material gain or the desire to become well-known. The motivating factor may be personal enrichment, or a need for funds for a not-for-profit association. People found guilt of fraud always have good excuses. Some simply do not realize what they have done. A knowledge of research methodology and critical appraisal methods can help to prevent fraud. Good clinical, laboratory and manufacturing practice can help to prevent misconduct and trickery. Audits and inspections are another essential means of combatting fraud.
France↗
Successful allogeneic bone marrow transplantation for early relapse after autologous bone marrow transplantation in two cases of aggressive high-grade non-Hodgkin's lymphoma.
Two patients with high-grade disseminated non-Hodgkin's lymphoma relapsed 3 and 7 months respectively after high-dose chemotherapy and autologous BMT performed in first complete remission. Both patients had an HLA-identical sibling and received an allogeneic BMT 5 and 10 months after autologous BMT, after conditioning with fractionated 12 Gy total body irradiation plus cyclophosphamide. They both are alive and well, with a Karnofsky score of 100%, 15 and 27 months after allogeneic BMT. For selected patients with HLA-identical siblings and good performance status who relapse after autologous transplantation for high-grade non-Hodgkin's lymphoma, allogeneic BMT may be an option.
Adolescent↗
[Malignant non-Hodgkin's lymphoma of the cervix. A case report].
Isolated malignant non Hodgkin lymphomas (MNHL) of uterine cervix are rare, and the therapeutic strategy is not always clearly established. The authors report a case of a 78-years-old woman presenting a MNHL FIGO stage IIB and Ann Arbor stage IE. Extention evaluation was negative. The histologic and immunohistochemical examination revealed a centroblastic lymphoma type G in the Working Formulation (WF). The patient was successfully treated by surgery followed with combination chemotherapy and external radiation therapy. Intermediate grade primary MNHL of the uterine cervix are the most frequent. The opportunity of surgery is discussed because lymphoma is a general disease with blood dissemination. We propose a therapeutic strategy according to patient age and the wishes for pregnancy. The young woman could undergo polychemotherapy, perimenopausal woman a combination of chemotherapy and radiation therapy, and post-menopausal woman surgery followed by external radiation therapy.
Aged↗
[Recommendations for clinical practice or consensus conferences?].
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Consensus Statements as Topic↗
[Paroxysmal nocturnal hemoglobinuria. Diagnosis aided by a monoclonal antibody directed against the decay accelerating factor glycoprotein].
The laboratory diagnosis of paroxysmal nocturnal haemoglobinuria (also called Marchiafava-Micheli disease) is based on the sensitivity of the patient's red cells to complement-induced lysis. In view of the clonal expression of the disease, haemolysis tests are difficult to interpret when the abnormal red cell population is small. The sensitivity of abnormal red cells to haemolysis is due to the absence of proteins attached to the cell membrane by a phosphatidyl-inositol link, which intervene in the regulation of the complement-induced lysis mechanism. Using a monoclonal antibody directed against one of these proteins, the decay accelerating factor (DAF, protein CD 55), makes it possible to diagnose paroxysmal nocturnal haemoglobinuria. DAF expression on patients' blood cells was measured by quantitative agglutination and by indirect flow cytometry. The agglutination test using polybren is a fast detection method, but it may be uninterpretable, notably in cases with positive antiglobulin (Coombs') test. In contrast, DAF expression measured by indirect flow cytometry correlates perfectly with measurement of red cell sensitivity by haemolysis tests. Using the monoclonal antibody by indirect flow cytometry is the method of choice to confirm the diagnosis of paroxysmal nocturnal haemoglobinuria and to measure the proportions of normal and abnormal red cells in case of haematological disorder.
Adolescent↗
[Vascular manifestation of thoracic outlet syndrome. Prospective study of 104 patients].
On the basis of a prospective study of 104 patients, the authors discuss the diagnostic value of the clinical symptoms revealing the thoracic outlet syndrome (TOS), as well as the specificity of the vascular functional exploration carried out to establish the diagnosis. Non-systematized pain and dysesthesia in the upper limb, with a postural or nocturnal onset, and Raynaud's sign are the most frequently observed signs. The "candlestick" maneuver still is the most reliable clinical triggering maneuver. The clinical features and the vascular functional explorations (capillaroscopy and digital plethysmography) allow demonstrating the existence of a true Raynaud's syndrome secondary to the TOS. The results of the arterial Doppler study distinguish the symptomatic and asymptomatic sides in the same patient, though without any correlation with the symptoms observed. The Doppler examination therefore seems to be reliable to demonstrate an anatomical duct, but remains insufficient to establish a causal relationship with the signal symptoms in most cases.
Adolescent↗
[Towards the adoption of international recommendations by the French medical journals?].
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France↗
[Tiopronin in 69 cases of rheumatoid polyarthritis treated earlier with D-penicillamine].
This study concerns 69 patients with rheumatoid arthritis (RA) and having received successively D-penicillamine (DP) then, after a mean period of 2 years, tiopronin (TP) at a daily dose of 1,500 mg. TP demonstrated an as frequent, as marked, and as prolonged effectiveness as that of DP. 28 patients are still under TP treatment, with a mean length of treatment of 43.7 months. The rate of effectiveness of TP was similar, whether or not the response to DP was favorable: 64.1 and 64.3 p. cent respectively; 72.4 p. cent of the 29 cases which did not respond to DP, responded favorably to TP. The manifestations of intolerance to TP were similar in nature (including the first reported case of obstructive bronchiolitis) and frequency to those observed with DP. There were only a few manifestations of crossed intolerance: the rate of TP discontinuation because of intolerance was the same, whether the DP was well tolerated (29.6%) or discontinued because of poor tolerance (30%). The same undesirable effect was only observed in 4 cases: one case of pemphigus, another case of toxic dermatitis, 2 proteinurias. This study confirms that TP represents a new, major long-term treatment of RA and demonstrates that this very product is an excellent take over medication.
Adult↗
[Efficacy of halofantrine in Plasmodium falciparum or Plasmodium vivax malaria in a resistance area (French Guiana)].
Halofantrine (WR 171.669) is a phenanthrene methanol derivative effective against the multidrug resistant strains of Plasmodium falciparum. One hundred and one patients, 48 men and 53 women, 53 adults and 48 children (less than or equal to 12 years old) aged from 1.5 to 57 years were treated. Fifty-one patients received a single 16 mg/kg dose and 50 patients received 24 mg/kg/day in 3 doses at 6-hour intervals. Parasite counts with examination of both thin and thick smears were performed twice daily for 5 to 6 days following treatment, or until smears were negative for parasites for 24 hours, and then weekly for 4 weeks. Thirteen patients reported clinical side effects. Six treated patients had no parasites. One patient had mixed parasitemia. Eighty three patients had P. falciparum malaria, with mean parasitemias between 26,850 +/- 36,679 and 35,412 +/- 50,527 per cubic millimeter. Halofantrine was very effective in the two doses tested from 87.5 to 100 p. 100. Eleven patients had in vivo resistant strains; ten in vitro tests were successful and nine were resistant to chloroquine. Thirteen patients with P. vivax and a mean parasitemia of 13,858 +/- 10,835 per cubic millimeter were cured but 3 had a relapse 3 to 4 weeks after treatment. At the 2 dosage levels tested halofantrine proved highly effective in the treatment of malaria caused by resistant and sensitive strains to P. falciparum.
Adolescent↗