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Biomedical subjects

C Hervé

Publications and source records attributed to C Hervé.

At least 37 records · Page 2Linked to original sources
PubMed2003

[The protection of persons and biomedical research in France. A multicentre study of 10 committees].

OBJECTIVE: Since 1988, any human biomedical research protocol in France must be submitted to a committee for the protection of persons participating in biomedical research programs (Comité consultatif de protection des personnes dans la recherche biomédicale (CCPPRB). This study is one of the first to analyse the functioning of the French CCPPRB at the onset of the application in 2004 of a European ruling on drug research, so as to study the pertinence of the opinions and the necessity or not of homogenising committee habits. METHOD: Ten CCPPRB participated in the study. An external observer visited all the centres. Three methodological instruments were used: semi-directive interviews with categories representative of the committee, analysis of the observer's documents and analysis of the discussions during dossier sessions. RESULTS: The habits are heterogenic regarding the crucial definitions represented by biomedical research and the limits of the latter. In half of the committees, the decision to investigate a protocol is taken by the president alone. All the dossiers are studied by one or several reporters, but not always within discussion sessions, hence underlining the need to respect the multidisciplinarity within a CCPPRB. CONCLUSION: These results show the importance of developing training courses for the members of a CCPPRB and the need to consecrate means for these CCPPRB, representing the democratic authority for the analysis of the protocols.

Bioethics↗
PubMed2003

[Collections of human biological resources for research purposes: from regulations to the need of a guide of good collection practices].

PURPOSE: In France, collections of human biological resources are regulated by the "Bioethics Law", currently in revision. Hence, we analyse the regulatory and ethical issues of these practices in the context of scientific research. The ultimate aim of such collections is to improve biological and medical knowledge. CURRENT KNOWLEDGE AND KEY POINTS: We think that the French regulatory system is quite complicated and non-explicit for "collection holders". The multiplicity of legal texts concerning this activity has made their application difficult, especially in the absence of application decrees. The project amending the actual law has clarified the legal status of collections but it did not shed light on the status of human body detached parts. Furthermore, the text is still very far from the international bioethical recommendations, and does not reflect the actual collection's implementation. FUTURE PROSPECTS AND PROJECTS: The establishment of a guideline of Good Collection Practices, based on clear principles, should help to simplify the situation, especially when it is imbedded in the regulation and linked to control procedures. It would allow a balance between collective interests and the protection of individuals, taking into account of the international highly competitive scientific and economical constraints. The major issue is to preserve and to perpetuate the existing and future collections because of their precious value as an important tool for biomedical knowledge. The efficiency of a regulation depends on its legibility and accessibility, two requirements that seem to determine the acceptance of the regulatory tool and its application allowing subsequently to reach fairness in proceedings.

Ethics, Medical↗
PubMed2003

[Committee on cancer of the upper aerodigestive tract and survey on buccodental aspects. Report of 164 teams].

BACKGROUND: Head and neck cancer occupies an important place in the field of oncology in France (8%). Patient management requires a wide diversity of treatment modalities and must be based on a multidisciplinary approach. MATERIALS AND METHODS: This clinical ethics study was based on analysis of a national survey of current practise in public and private hospital structure. A 28-questions anonymous questionnaire was send to 164 practitioners caring for these patients from the stage of diagnosis and evaluated the modalities of dental treatments and the related ethical aspects. RESULTS: The competence of the various practitioners in their respective fields is undeniable, but there is a lack of multidisciplinary collaboration. The absence of an oral practitioner is a serious problem and can reduce the patient's chances of cure. DISCUSSION: The oral practitioner must participate in head and neck cancer committees at all steps of treatment in order to provide curative, preventive care and prosthetic rehabilitation, thereby contributing to improvement of the quality of life of these patients.

Clinical Competence↗
PubMed2002

Knowledge about contraception in women undergoing repeat voluntary abortions, and means of prevention.

AIMS: Despite reliable and effective means of contraception, cases of repeat abortion are on the increase in all developed countries. The aim of this work was to determine whether women undergoing repeat abortions are exposed to risk factors which might be amenable to preventative measures, and the methods employed by carers in these cases. METHODS: We set out to evaluate practices in the Family Planning Centre of l'Hôpital Jean Verdier (Bondy, France) by sending a questionnaire to 147 women who had undergone two abortions up to 1997, and by conducting interviews with the care team. Thirty patients responded to the questionnaire. RESULTS: Twenty-two women (73%) underwent one or more further abortions between 1999 and 2000. Twenty-seven out of 30 women were unaware of the existence of emergency contraception. The 'morning after' pill, indicated for cases of unprotected sex, was unknown to one woman in two (15), nine out of 30 did not know what 'back-up' measures they should take after missing a dose of the contraceptive pill. Psychological problems were found in nine cases. These were followed up with a psychological consultation in three cases. The information given to the patients by the carers was the same irrespective of the number of abortions. Poverty and psychological problems were noted by the carers. CONCLUSION: Patients who have undergone two abortions might benefit, in addition to their routine visits, from a consultation with a psychologist and a consultation providing information about contraception. Providing the contraceptive pill free of charge to low-income patients is essential.

Abortion, Induced↗
PubMed2002

[The Perruce decree, an opportunity to question the acceptance of a handicap and the relationship between physicians, justice and society].

The 'Perruche' decree (confirmed by the Paris Court of Cassation in November 2001) recognizes the right of those born with a handicap to claim for compensation. However, there is a fear that this decree might lead to deviations in the requests submitted for systematic compensation, simply because of a handicap or prejudice, even in the absence of a medical error. The interest of the 'Perruche' decree is that it once again raises the question of the management of handicapped people in our society and the lack of sufficient help from the State. The decree also emphasizes the strong subjacent risk that a handicap could be considered as a failure or a medical error. The excessive ideology of a 'perfect' child may therefore provoke the reject of the idea that a human being may be born with a deficiency or "imperfection". It also reminds us that medical practice remains exposed to errors and incertitude and that a zero risk does not exist, contrary to certain fantastical beliefs fostered by the principle of precaution. The hazard may correspond to the notion of incertitude. But it must not be confused with an error and it implies that which is unforeseeable. It is important that physicians stall the faith in the power of ultramodern techniques. Conversely, they should not claim a right to systematic error, when errors in fact hide authentic faults. The medical discourse must therefore remain responsible.

Congenital Abnormalities↗
PubMed2002

[Evaluation of the risk of abortion abuse resulting from the two-week legal delay in France].

OBJECTIVE: The legal delay for abortion in France has recently been prolonged from 10 (12 weeks of amenorrhea) to 12 weeks (14 weeks of amenorrhea). With the progress in sonography, certain foetuses may exhibit malformations during the first trimester. Diagnosis of foetal gender at 12 weeks of amenorrhea is sometimes possible. We studied the possibility that the prolonged legal delay before abortion might incite women to abort, simply on sonographic criteria. METHODS: Our enquiry was conducted in March 2001 in the department of Obstetrics and Gynaecology of the Jean Verdier hospital in Bondy. Two questionnaires were drawn-up by the Medical Ethics Laboratory of the Necker Hospital in Paris and were distributed to 128 women and 24 nurses. RESULTS: Recourse to abortion was high if laparoschisis or the absence of a hand was revealed, low in the case of opacity of the neck, and almost inexistent in the case of unwanted gender, in a female population with less than one child. CONCLUSION: A national consensus on foetal abnormalities to be searched for, and not to be searched for (Number of fingers? Upper lip?...) and the eventual detection of the gender during sonography of the 1st trimester is urgent in view of the technological progress made. Clear and reassuring information is essential when confronted with foetal abnormalities and must lead to complete and precise antenatal diagnosis (caryotyping, sonographic control 2 or 3 weeks later).

Abortion, Legal↗
PubMed2002

[Clinical study and prevalence of fetal alcohol syndrome in medico-social institutions of the Reunion Island].

BACKGROUND: Fetal alcohol syndrome (FAS) is a major problem in the Reunion Island and the Public Health Authorities decided to determine its prevalence in their medico-social centers on 31 December 1996. MATERIAL AND METHODS: A questionnaire was established to identify affected patients in the 20 medico-social centers in charge of 1320 children. Eighty-eight children were selected and 87 could be analyzed. RESULTS: Sixty-four of 87 (76.3%) were FAS and 23 of 87 (23.7%) had closely alcohol-related diseases. The prevalence was between 7.1 and 14.1% and lower than expected from available data. CONCLUSION: The study allowed to precise the social and familial factors predisposing to alcohol addiction during pregnancy. A TV prevention message will be broadcasted after this study.

Adolescent↗
PubMed2002

[Proposing surgical management to a patient with low-grade glioma: controversies and ethical consequences].

The therapeutic controversies surrounding low-grade glioma result mainly from the lack of certainty about their histological definition, and, from our imperfect knowledge of the natural history of the disease. Heterogeneous surgical management is the consequence of this situation, which renders difficult to propose the best attitude to each individual patient, thus raising ethical questions, because the absence of a consensus. Performing prospective studies able to analyse these different modalities is mandatory whenever we want to be enable to give to our patients the best answer in their precise case, and furthermore to justify back our acts too.

Attitude of Health Personnel↗
PubMed2001

[Living donors for transplantation and bioethics laws. Survey with French transplantation professionals].

OBJECTIVES: Renewed interest in living donor transplantation in France led us to survey French transplanters to determine their opinion concerning this technique and the ethical issues involved. Their concerns and suggestions about current legislation were examined. METHODS: An anonymous questionnaire was sent to physicians working in the different kidney, liver and lung transplantation units operating in France. RESULTS: French transplanters expressed a wide range of opinions concerning living donor transplantation and possible broadening of the current regulations. Sixty-two percent of the transplanters had a positive opinion on living donor transplantation compared with 22% who expressed a negative opinion. For 23% of the transplanters, it is preferable to transplant with a living donor graft compared with 64% who preferred cadaveric grafts. A living donor transplantation program is under study in 65% of the units. There is some debate concerning the legitimate nature of the emergency donation situation for spouses. About one-half of the transplanters were in favor of controlled extension of potential donors to second degree relatives and to the recipient's spouse or living partner. CONCLUSION: There is no real consensus among French transplanters concerning living donor transplantation due to the complexity of the ethical issues involved. Their opinions reflect medical tradition with background marked by autonomy and paternalism. This leads to a wide range of opinions concerning current bioethics legislation and the usefulness of more flexible laws.

Bioethics↗
PubMed2001

[Tubal sterilization in mentally handicapped women].

ETHICAL ISSUES: When performed for contraception purposes, tubular sterilization for mentally handicapped women poses important ethical issues, including patient's rights, body integrity, and the notion of informed consent. French law guarantees the respect and safety of all patients, but in everyday practice, patient's rights must be upheld by family and healthcare workers searching for the most adapted solutions for each individual situation. PROPOSITIONS: We present here our proposals for everyday practice. Our conclusions are based on an analysis of the notion of handicap as defined by the WHO and on the observed sexual activities of this type of patient. In this context, informed consent involves a number of subjective factors pointing out the difficulty encountered in providing dear comprehensible information. Finally we discuss the ethical issue of tubular sterilization which many consider to be a masked form of eugenism.

Ethics, Medical↗
PubMed2001

[Access to care, access to rights, and health education: stakes of the global management fo patients].

Together with primary care physicians, the public health clinic of the Max Fourestier Hospital (Nanterre, France) initiated a pilot experience within the framework of its access to health care network (ADES). In addition to full access to traditional health care, patients who agree to participate in this unique network benefit from a medical and social risk screening and prevention program. This program is proposed to all patients who, by definition, have one or more medical or social risk factors. At each visit, targeted history taking and the physical exam can lead to individualized propositions for a global approach to screening and prevention, whatever the initial reason for consulting. In addition, patients who require permanent care benefit from the dose link between the medical care and social care teams. Over the last year, this experience has involved 3430 consultations in a polyvalent clinic that has provided global care including health education and screening for health risks. Our analysis of the medical and ethical issues involved points out the importance of a global approach to health care.

Ethics, Medical↗
PubMed2001

[The risks of unrestricted application of the principle of precaution in medicine. The need to keep in mind the findings of medical ethics in the development of health care rights].

The principle of precaution, a fundamental, essentially legalistic, rule underpinning health care legislation in France, basically arose from environmental protection policies. This principle became the topic of a good deal of well-publicized debate following the decree concerning HIV contamination rendered in 1993 by the Conseil d'Etat, the supreme jurisdiction on legislative matters in France. This translation of a fundamental principle from one domain to another is not devoid of significance and could have an unexpected impact on the nature and meaning of health care itself. When applied to medicine, the principle of precaution must be confronted with the notion of risk, inherent in all acts of health care. This risk certainly implies patients' rights and informed consent to medical care, but also, in a reasonable search for an acceptable balance between risk and benefit, the freedom of biomedical research from overly-restrictive regulations. Consequently, in accordance with an ethical approach to medical care, legislative and judicial bodies must take into consideration the practical reality of medicine in order to integrate the scientific, economic, social, and psychological aspects of everyday medical practice into health care laws and regulations. Once faced with the reality of health care, the principle of precaution could appear contradictory to the fundamental principles of medicine. Indeed, every physician, every health care worker, makes daily evidence-based decisions that are never devoid of risk. Unrestricted application of the principle of precaution to a growing number of public domains, including medicine, as advocated by a large number of opinion leaders, could lead to an inextricable situation, in total contradiction with the goal of health care itself. In order to develop new truly ethical and adapted health care regulations, we must break down the barriers confining judges and legal representatives to a purely legalistic vision of health care and equally confining physicians to a purely scientific vision of their mission.

Defensive Medicine↗
PubMed2001

[Knowledge of flap complications in finger pulp surgery and patient education--ethical implications].

INTRODUCTION: The two highest French courts have recently decided that not to fully inform a patient constitutes negligence, and that doctors should be able to prove that the information has been given. The medical community is now debating as to how to protect physicians without harming the doctor-patient relationship. Following this study we put forward the hypothesis that although information might not be available to surgeons nevertheless this should not prevent them taking the ethical steps necessary to redress the situation. METHODS: We conducted a telephone interview to discover what surgeons knew about the complications of finger flaps used for the reconstruction of pulp defects. Four flaps were studied: the VY flap described by Atasoy, the island finger flap known as Ventataswami's, the reverse island flap and the thenar flap. Surgeons were asked to give the percentage of necrosis, infection, sensory disturbances, digital stiffness and exclusion, as well as the time off work, the time of healing and the sensory discrimination of the flap. The results obtained were compared to those obtained by a literature review. RESULTS: Twenty one qualified hand surgeons answered the questionnaire. Many answers were absent or only fragmentary when sought in the literature. Where complication rates were available, there was a huge variation among series. A large variety of answers was also found in our study. The direct island flap was the best known flap. Complications of the reverse island flap and the thenar flap were overestimated in the group interviewed. DISCUSSION: There is no true answer, either in the literature or from the study group. There is a gulf between the jurists' demand and the possibilities of knowledge by surgeons. We are still waiting for clinical studies that will answer the questions asked by patients regarding the complications of surgery. However, even if absolute knowledge is not available, it is the ethical duty of surgeons to give the patient information that is as close as possible as the "truth", and that will be helpful to them.

Adult↗
PubMed2001

Evaluation, selection, and follow-up of live kidney donors: a review of current practice in French renal transplant centres.

BACKGROUND: A resurgence of interest in the concept of live-donor renal transplantation has prompted a closer look at methods of live donor evaluation, selection, and follow-up. The aim of this study was to describe these methods in all 46 French renal transplant centres. METHODS: Questionnaires were sent to all chief renal physicians. RESULTS: The survey was completed by 78% of centres, which accounted for 95% of all live-donor renal transplants carried out in France in 1995 and 1996. There was a substantial variation in all three steps of live-donor management. For example, we observed variations in the screening for specific short- or long-term risk factors (especially cardiovascular or thrombotic risk factors and diabetes). In addition the exclusion criteria differed, especially the cut-off age for donation, which ranged from 45 to 75 years. The composition of teams evaluating and selecting potential donors and the role of the potential donors in the decision-making process varied greatly among centres. Finally, we observed less variation in the methods of donor follow-up. CONCLUSIONS: The current survey revealed a marked disparity in the management of live donors in France. It raises the question of whether these practices should be codified into a set of guidelines for live-donor transplantation.

Adult↗
PubMed2001

French intensivists do not apply American recommendations regarding decisions to forgo life-sustaining therapy.

OBJECTIVE: Recommendations for making and implementing decisions to forgo life-sustaining therapy in intensive care units have been developed in the United States, but the extent that they are realized in practice has yet to be measured. DESIGN: Prospective, multicenter, 4-wk study. For each patient with an implemented decision to forgo life-sustaining therapy, the deliberation and decision implementation procedures were recorded. SETTING: French intensive care units. PATIENTS: All consecutive patients admitted to 26 French intensive care units. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 1,009 patients admitted, 208 died in the intensive care unit. A decision to forgo life-sustaining therapy was implemented in 105 patients. The number of supportive treatments forgone was 2.3 +/- 1.7 per patient. Decisions to forgo sustaining therapy were preceded by 3.5 +/- 2.5 deliberation sessions. Proxies were informed of the deliberations in 62 (59.1%) cases but participated in only 18 (17.1%) decisions. The patient's perception of his or her quality of life was rarely evaluated (11.5%), and only rarely did the decision involve evaluating the patient's wishes (7.6%), the patient's religious values (7.6%), or the cost of treatment (7.6%). Factors most frequently evaluated were medical team advice (95.3%), predicted reversibility of acute disease (90.5%), underlying disease severity (83.9%), and the patient's quality of life as evaluated by caregivers (80.1%). CONCLUSIONS: A decision to withhold or withdraw life-sustaining therapy was implemented for half the patients who died in the French intensive care units studied. In many cases, the decision was taken without regard for one or more factors identified as relevant in U.S. guidelines.

Adult↗