Christian Hervé

Prehospital use of APSAC: Results of a placebo-controlled study

Thrombolytic treatment efficacy is greater when the delay between onset of pain and treatment is short. To give treatment before admission to a coronary care unit, responsibility needs to be transferred from cardiologists to other physicians working in mobile care units. We conducted a 2-part feasibility study to investigate this strategy. Part 1 evaluated the diagnostic accuracy of mobile care unit physicians. Results from this study indicate that with regard to the diagnosis of acute myocardial infarction, the risk of a wrong diagnosis is low. Part 2 was a placebo-controlled trial involving 100 patients in which 57 received anisoylated plasminogen streptokinase activator complex (APSAC) (30 U) at home and 43 received placebo at home. Patients receiving placebo at home were reevaluated on arrival in a coronary care unit and received APSAC (30 U) if indicated. The main results were that (1) diagnostic accuracy was good--all patients had an acute coronary syndrome and 97 of 100 patients had myocardial infarction; (2) time gain was approximately 60 minutes; (3) coronary patency rate was 72%; (4) ejection fraction was higher in the prehospital group (56.7%) than in the control group (53.4%), but the difference was not significant; (5) there was no rhythmic or bleeding complication related to the prehospital treatment; (6) 5 patients died from cardiogenic shock--2 between home and hospital and 3 in the hospital (3 received thrombolytic treatment at home and 2 received placebo at home and APSAC in the hospital); and (7) prehospital administration of APSAC did not induce a delay in arrival to the coronary care unit.(ABSTRACT TRUNCATED AT 250 WORDS)

Depression, anxiety and quality of life: outcome 9 months after facial cosmetic surgery

OBJECTIVEnThe request for cosmetic surgery is of a psychological nature. Very few studies have quantitatively assessed whether or not this psychological need was actually satisfied, and more precisely, which psychic components were satisfied.nnnMATERIAL AND METHODSnThis is a multicentric, prospective cohort study. One hundred and three patients scheduled for facial cosmetic surgery from three different hospitals were examined before and after surgery using four assessment scales validated using European populations. The Montgomery and Asberg depression rating scale (MADRS) measured the existence and intensity of depression, the self-assessment test of thoughts in social interaction (SISST) measured the positive or inhibitory thoughts in the context of social relationships, and the European quality of life 5 dimensions (EQ-5D) (generic test) measured the quality of life. In addition, a semi-directive interview was specially created by our team. For statistical analysis, ANOVA and Students t test were applied.nnnRESULTSnTwenty-four patients were lost to follow-up. Although the initial MADRS index was high (p<0.05), it did not change after surgery (p>0.1). SISST+ (positive thoughts): the social anxiety of the individual examined was significantly greater than that of the control group (p<0.005) and improved after surgery (p<0.01). The SISST- (inhibitory thoughts) did not change (p>0.1). The EQ-5D visual analogue scale (VAS) did not reveal any difference (p>0.1) while the descriptive EQ-5D demonstrated over-representation of anxiety/depression (p<0.01), and an improvement of this (p<0.05) postoperatively. The mean subjective satisfaction index was 8.1 (scale of 1-10) without sharing any influence of the complications suffered (65% of the patients made self-assessments).nnnCONCLUSIONnThe best indications for facial cosmetic surgery seem to be a lack of self-confidence associated with a desire for social interaction, and a request focused on a specific physical feature. The results presented add documentary confirmation to the impression shared by the majority of cosmetic surgeons. However, it was also confirmed that cosmetic surgery is not limited to its technical components, but remains a medical act which must consider the overall effect on the whole patient.

What about Informed Consent in First-Trimester Ultrasound Screening for Down Syndrome?

Objectives: We evaluate the level of information and informed consent given for the screening of Down syndrome (DS) before the first-trimester ultrasound scan. We evaluate the nature of the medical information given and the patient’s understanding. This makes it possible to analyze the existence of the necessary elements (level of information and consent) for the patients to exercise their autonomy as to their decision making during the first-trimester ultrasound scan. Methods: A total of 350 patients were recruited prospectively in 2 hospitals. Patients were divided into 3 groups according to the results of maternal serum screening for DS. Group 1: Patients at high risk of having a child with DS with the second-trimester maternal serum screening (MSS) (risk >1/250). Group 2: Patients having a low risk (risk <1/250). Group 3: Patients who did not undergo maternal serum screening test. A questionnaire was completed before the medical consultation, to assess the quality of the medical consultation before the ultrasound, the level of prior knowledge and the maternal consent. Results: We excluded 45 of the 350 questionnaires from the analysis because they were incomplete (13.1%). We therefore analyzed a total of 305 questionnaires. The three groups analysed were: Group 1: 89 patients (29.2%) identified as at high risk after MSS. Group 2: 137 patients (44.9%) identified as at low risk accordingly to MSS. Group 3: 79 women (25.9%) who did not undergo maternal serum screening test for diverse reasons. The frequency of genuine informed consent was significantly (p < 0.001) higher in group 3 (56.9%) than in group 1 (52.8%) or group 2 (32.1%). Finally, the number of completely uninformed patients was significantly higher in group 2 (18%) than in the other two groups (7.8% for group 1 and 6.3% for group 3, p < 0.001). With multiple regression analysis, we found that maternal consent depended on 4 independent components: (1) Educational level (<baccalaureate, baccalaureate or at least 2 years of higher education after baccalaureate) (p < 0.03). (2) The location of consultations (hospital or private doctor’s practice) (p < 0.01). (3) History of medical termination (p < 0.001). (4) The score attributed to the doctor for information about early ultrasound scans (p < 0.001). The rate of consent increased with increasing educational level and was higher for women consulting at a hospital, for women with a history medical termination and for women whose doctors had a high score. Other criteria such as belonging to group 1, 2 or 3, age of the patient, first language, number of children, history of miscarriage, sex and age group of the professionals were not found significant. Conclusions: The response to the question ‘Is the level of medical information provided to patients concerning early screening by first-trimester ultrasound scans appropriate?’ is ‘no’. There is no difference in our result according to social-economic level. However, educational level (66% consent for patients with 2 years of higher education after the baccalaureate), a history of medical termination (85% consent), being followed at a hospital (77% consent) and the score of the doctor (71% consent) were all significantly associated with the level of consent to prenatal screening. It is difficult for patients to exercise their autonomy as concerns first-trimester ultrasound scans. Too many patients (82%) consider such scans to be compulsory. Overall, the level of knowledge of the patients was moderate, with 227 of the 305 patients (74%) having a satisfactory knowledge score (≧10). The negative responses to the various questions calls into question the legitimacy of consent for first-trimester ultrasound scans, particularly as concerns the measurement of nucal translucency.

Impact of an intensive communication strategy on end-of-life practices in the intensive care unit

PurposeSince the 2005 French law on end of life and patients’ rights, it is unclear whether practices have evolved. We investigated whether an intensive communication strategy based on this law would influence practices in terms of withholding and withdrawing treatment (WWT), and outcome of patients hospitalised in intensive care (ICU).MethodsThis was a single-centre, two-period study performed before and after the 2005 law. Between these periods, an intensive strategy for communication was developed and implemented, comprising regular meetings and modalities for WWT. We examined medical records of all patients who died in the ICU or in hospital during both periods.ResultsIn total, out of 2,478 patients admitted in period 1, 678 (27%) died in the ICU and 823/2,940 (28%) in period 2. In period 1, among patients who died in the ICU, 45% died subsequent to a decision to WWT versus 85% in period 2 (pxa0<xa00.01). Among these, median time delay between ICU admission and initiation of decision-making process was significantly different (6–7xa0days in period 1 vs. 3–5xa0days in period 2, pxa0<xa00.05). Similarly, median time from admission to actual WWT decision was significantly shorter in period 2 (11–13xa0days in period 1 vs. 4–6xa0days in period 2, pxa0<xa00.05). Finally, median time from admission to death in the ICU subsequent to a decision to WWT was 13–15xa0days in period 1 versus 7–8xa0days in period 2, pxa0<xa00.05. Reasons for WWT were not significantly different between periods.ConclusionIntensive communication brings about quicker end-of-life decision-making in the ICU. The new law has the advantage of providing a legal framework.

La personne de confiance, nouvel outil de la relation médecin patient

THE NOTION OF A PERSON OF TRUST: Introduced by the law dated March 4th 2002, the person of trust is there to accompany the patient in all his/her measures of care; this person is also conceived as an helper in medical decisions or when the patient participates in biomedical research protocols. DESIGNATION MODALITIES: Any adult, unprotected patient can designate a person of trust, whose intervention is not only limited to hospitalisation (the nursing staff are obliged to propose such a person), but can also intervene during care at home or at the doctors. The designation is made in writing and can be revoked at any time. The person of trust can be a relative, a friend or even the treating physician. A SPECIFIC ROLE: The person of trust can be of help in medical measures in routine medicine when the patients needs to be accompanied, and in the case of diagnosis or serious prognosis, and when the patient is incapable of expressing him/herself.

Ethical questions raised by the first allotransplantations of the face: A survey of French surgeons

INTRODUCTIONnMore than any other allograft, the allotransplantation of the face has a symbolic character, which raises a large number of questions. The objective of this article is to make an analysis through a survey carried out among French surgeons.nnnMETHODSnA file of 909 e-mail addresses of surgeons was created so as to send out a questionnaire regarding 10 ethical issues.nnnRESULTSnBeyond the technical prowess, the surgeons ethical reflection initially focused on the notion of consent to donation and care. They attached equal importance to all ethical questions. They spontaneously raised the issue of over-mediatization of these first transplants and the place of the transplant surgeons and their patients in the medical information.nnnCONCLUSIONnOver two thirds of the surgeons attached importance to ethical issues regarding the donor and recipient of a facial allograft. Some of the principal questions facing facial transplantation is of an ethical nature as it is an unprecedented procedure that is challenged by the axiom to first do no harm and the need of modern medicine to limit risk to as close to zero as possible. For the non-specialist, accepting psychologically the face of another individual appears to be a real issue. Contrary to that, the main demand expressed by the facial transplant recipients appears to be related to facial functions rather than appearance.

Is post-mortem ultrasonography a useful tool for forensic purposes?

Purpose To investigate the interest of post-mortem ultrasonography in the diagnosis of pathological background, and manner and cause of death. Methods Post-mortem ultrasonography exams were carried out on 38 fresh human adult cadavers referred to the Department of Forensic Medicine and Pathology (Garches, France). Data obtained from ultrasonography were independently compared with further forensic autopsy findings. Results Two important limitations relative to ultrasound utilization appeared: hyper-echoic abdominal and thoracic walls, with gas distension of the whole digestive tube and subcutaneous tissues (due to precocious putrefactive gas releasing); and difficulty in accessing lateral and posterior structures (i.e. liver, spleen, kidneys, lung bases, aorta) due to rigor mortis and evident non-compliance of the subject. Post-mortem diagnoses (moderate ascites, gallbladder stones, bladder globe, chronic kidney disease, cirrhosis, thyroid gland cysts and hypertrophy, intrauterine device), were strongly limited. False negative diagnoses comprised fatty liver, pleural effusion, thoracic aortic dissection, and focal organ and/or soft tissues lesions (for example, wounds or infarcts). Conclusion According to the results, post-mortem ultrasonography seems to have a very limited role for forensic purposes. Other post-mortem utilizations are cited, proposed, and discussed.

[How to avoid research misconduct - recommendations for surgeons]

Research misconduct is defined by the Royal College of Physicians of Edinburgh as any behaviour by a researcher, whether intentional or not, that fails to scrupulously respect high scientific and ethical standards. Various types of research misconduct include fabrication or falsification of data, plagiarism, problematic data presentation or analysis, failure to obtain ethical approval by a research ethics committee or to obtain the subjects informed consent, inappropriate claims of authorship, duplicated publication, and undisclosed conflicts of interest. These can result in patient injury, deterioration of the patient-physician relationship, loss of public trust in biomedical research, as well as pollution/degradation of the medical literature. Surgical research malfeasance has been underreported, and no practical guidelines for good research and publication have appeared to date in French surgical journals. In an attempt to uphold the scientific integrity of our profession, we discuss research misconduct and emphasise preventive measures and considerations for surgeons.

La personne de confiance : émergence, évolution et enjeux éthiques

La loi francaise du 4 mars 2002 a instaure la possibilite pour toute personne majeure de designer une personne de confiance. Celle-ci peut accompagner le patient dans ses demarches de soins et devenir en cas de besoin, un intermediaire privilegie pour representer l’avis du patient et a ce titre, elle peut etre consultee sans toutefois aller jusqu’a se substituer au consentement du patient.

Is the non-respect of ethical principles by health professionals during first-trimester sonographic Down syndrome screening damaging to patient autonomy?

To evaluate the understanding of health professionals involved in first‐trimester ultrasound screening of the ethical stakes involved by addressing three questions regarding: how much these professionals know about Down syndrome screening by nuchal translucency thickness measurement; their personal opinion with respect to this screening test; and their attitude with respect to their patients, in order to answer the question: ‘Are ethical principles respected when women are proposed ultrasound screening during the first trimester of pregnancy?’.