[The radiolabeled blood cell: Finding a legal qualification]. / La cellule sanguine marquée par un radionucléide : recherche d'une qualification juridique.

Radiolabelling of blood cells is a technique commonly used as a diagnostic tool in nuclear medicine; it has never been legally defined. This lack of legal status is a factor of uncertainty for both patients and health care professionals. The aim of this work was to identify what could be the legal nature of the radiolabelled blood cells by comparing their constitutive elements to the various existing legal categories applicable, according to the law applicable to living organisms as well as the regulations for other health products. The study concludes that, as it stands, the radiolabelled blood cells undoubtedly belong to the category of a drug by function for diagnostic purpose. More precisely, it is compared to a radiopharmaceutical medicinal product resulting from a well characterised manufacturing process. In order to increase visibility and thus the actors' awareness of the constraints arising from this specific status, it is proposed to create a specific legal regime for the radiolabelled blood cells by including in Article L. 5121-1 of the French Public Health Code a new category of health product which could be called: radiopharmaceutical preparation of cellular blood component for diagnostic purposes. The consequence of this proposal will mechanically place the radiolabelled blood cell preparation under the exclusive competences of radiopharmacists practising in an hospital pharmacy. Another important consequence will be that the radiolabelling process of blood cells will have to fulfil the rules of the French good hospital pharmacy practices and good preparation practices, for the benefit of patient protection and safety.

Evaluation of the quality of life of pregnant women from 2005 to 2015.

Over the past two decades, quality of life has become an essential preoccupation in the care of patients. Many measuring instruments are available to assess physical, psychological and social quality of life. These tools allow healthcare professionals to determine the best quality of their patients. However, the quality of life for the pregnant woman seems to be little studied. This article presents the results of a bibliographic review of publications between 2005 and 2015 - referenced in PUBMED and COCHRANE - on the quality of life of pregnant women giving birth after the 22nd week of amenorrhea. The articles were selected by a reading committee. 195 publications responding to keywords were identified. 75 articles on the problem were selected. The main countries that have published on this subject are Iran (n=11) and Brazil (n=9). France ranks 17th with only one publication. 74% of articles deal with quality of life for pathological pregnancies (gestational or pre-existing pathologies). 23 pathologies were identified, mainly depression (20% of items). This review reveals a growing global interest in quality of life in pregnant women. However, few studies evaluate the impact of care in terms of quality of life in pregnant women, contrary to the recommendations of different health authorities. Finally, the analysis of the various articles shows that, in general, few measurements are made to evaluate the quality of life, not requiring a standardized curve of quality of life during pregnancy. There is thus a significant lack of data to establish a standardized curve for the quality of life of pregnant women, which allows a simple comparison of quality of life measures according to the different clinical management.

Return home at the end of life: Patients' vulnerability and risk factors.

Although most of the people in good health questioned about the subject said they would like to die at home, in the western world between 60 and 80% of deaths occur in hospital. Most authors consider that the indispensable conditions for a return home are the patient's desire and presence of the family and caregivers with the appropriate skills. The assessment of other factors predictive of a return home is inadequate. The aim of this study is to clarify how the return home is influenced by the vulnerability of the patient at the end of life, and by that of the family and caregivers. We carried out a multicentric, observational, prospective, exhaustive and longitudinal epidemiological study (three months follow-up), including 146 patients hospitalized at the end of their life and desiring to return home. For these patients the caregivers respected their freedom to choose to die at home in over half the cases (56%). Their overall vulnerability (personal, family context and caregivers) had a significant influence on the return home. This overall vulnerability was in fact identified as applying in 40% of the clinical situations, and made the possibility of a return home 50% less likely.

[Defining and assessing competence of healthcare professionals. A survey of 148 organizations]. / Définir et évaluer les compétences des professionnels de santé. Une enquête auprès de 148 organisations.

INTRODUCTION: To study how competence is described and perceived by organizations of healthcare professionals in France and propose approaches toward implementing a policy to monitor and assess competence throughout medical professionals' careers. METHODS: After a literature search, we sent 160 letters to organizations representing 16 healthcare professions (listed in the French healthcare code) describing our objectives and proposing interviews. Semi-structured interviews (45-90 minutes) were conducted. The principle questions asked were: What is your organization's definition of competence? What are the principal elements that define competence in healthcare activities? How can a system for assessing competence be implemented? Which methods for such a system are most appropriate, based on experience in other countries? Who are the players in the field of competence? How can organizations participate in monitoring competence? RESULTS: 265 people representing 148 French organizations were interviewed. Analysis of the interviews showed that the principal points mentioned included: need for recognition; lack of training on new developments; need to anticipate changes; need for better health security in the healthcare system. There was a general consensus on the basic elements of competence, the responsibility of public institutions and professional organizations, and the need to work together. DISCUSSION: We suggest that competence in health care should be defined as follows: "professional competence is based on an initial diploma, participation in effective continuing medical education, a minimum amount of professional activity, and a regular peer review process". Healthcare professionals in France would like to have a better system that allows them to exchange more information on the principal issues in health care.

[The accreditation procedure: An external recognition of quality in public and private health centres in France. ]. / La rocedure d' accreditation: Une reconnaissance externe de la qualite dans les etablissements de sante publics et prives en france.

Since early 1990, the structures and financing of various health systems have been reformed. For the first time, some western Europe countries have admitted that quality insurance within the health system can become a governmental responsibility and, as in the past, simply the responsibility of the professionals and/or the health service administrators. During the last decade of the XXth century, pressure has gradually been increased for governments to become more involved in health system quality. This focus on quality was linked to human safety. In this historical perspective, the emergence of AIDS and the difficulty to control this epidemic, and the consequences of contamination by injection needles have probably played a part in this collective awareness. In this context, quality has become a major concern in Europe.

Evaluation of 60 continuous quality improvement projects in French hospitals.

OBJECTIVE: To evaluate the feasibility of implementing continuous quality improvement (CQI) projects in French health care organizations. DESIGN: The French Ministry of Health issued two calls for CQI projects (in 1995 and 1996). ANAES was commissioned to monitor and evaluate the projects, and to provide advice. SETTING: ANAES in collaboration with French public hospitals. STUDY PARTICIPANTS: A jury selected 64 projects from 483 submissions. The first series of projects related to safety issues (e.g. blood transfusions), the second related chiefly to patient management. INTERVENTIONS: ANAES instructed project leaders in process analysis (modified four-step FOCUS-PDCA model), convened regular meetings between leaders and performed on-site visits. MAIN OUTCOME MEASUREMENTS: Objective outcomes: goal achievement, extension of projects to other topics and departments, allocation of resources. Subjective outcomes: changes in attitudes. Statistics were obtained from two questionnaires completed by project leaders. RESULTS: Four projects were discontinued; 82% (49 out of 60) met more than half their objectives. The CQI method was adopted by other departments in 65% and 50% (1st and 2nd series respectively) of cases. Hospital management often chose to provide continued support (81%/88%), offer training (59%/80%), create a CQI unit (62%/73%), and allocate a budget (61%/65%). A positive impact on staff attitudes was noted in over 75% of projects. CONCLUSION: ANAES' co-ordinated initiative to acquaint a hard core of French public hospitals with CQI proved successful. Identification of the factors for success and of potential hurdles helped pave the way for the national hospital accreditation procedure currently underway.

Unjustified variations in patient management for acute myocardial infarction in the Rhône-Alpes region of France. PRIMA Group.

OBJECTIVES: To examine determinants of use of cardiac procedures after acute myocardial infarction and identify variation factors. METHODS: Observational prospective cohort study of 2,519 patients in 48 centers with a two-level logistic-regression analysis. RESULTS: Elderly patients were less likely to undergo pre- and inhospital thrombolysis (odds ratios, 0.71 and 0.64; 95% CI, 0.62-0.81 and 0.58-0.69, respectively). The elderly, females, and patients with heart failure on admission were less likely to undergo noninvasive tests (0.74, 0.62, and 0.51; 95% CI, 0.67-0.81, 0.46-0.83, and 0.38-0.68, respectively) and coronary angiography (0.38, 0.53, and 0.67; 95% CI, 0.34-0.42, 0.38-0.74, and 0.52-0.86, respectively) but not revascularization. Hospital factors were more difficult to interpret. CONCLUSIONS: Elderly, women, and heart failure patients underwent fewer cardiac procedures than lower-risk patients. Physicians should change their attitude toward these groups and use advanced procedures, bearing in mind the patients' needs rather than good procedural outcomes.

[The impact of the data collection method on the medico-economic classification of admissions for myocardial infarction at the public hospitals in Lyon]. / Impact du mode de recueil des données sur le classement médico-économique des séjours pour infarctus du myocarde aux Hospices Civils de Lyon.

The aim of the PMSI (Programme de Médicalisation du Système d'Information) is to describe the activity of hospitals for budget allocation. To control the quality of this information, the authors carried out a study comparing the classification in homogenous disease groups (HDG) obtained from the PMSI with that obtained from the epidemiological data base of the PRIMA trial for patients admitted to the Civil Hospitals of Lyon for myocardial infarction between September 1st 1993 and January 31st 1995. Six hundred and fifty standardised hospital summaries were reconstituted form PRIMA data and grouped using the GENRSA 3 software. Five hundred and forty-one of these hospital stays were found in the PMSI data base and grouped. The concordance not due to chance between the two classifications was then assessed by the global kappa coefficient. It was less than the 40% threshold under which concordance not due to chance is considered to be unlikely. The discordances were essentially due to the presence of an associated diagnosis classifying the hospital stay in the HDG corresponding to complicated myocardial infarction. The presence of a classifying associated diagnosis was observed significantly more often in the PRIMA than in the PMSI data base. This results in an underestimation of the hospital activity and could have important repercussions in terms of budget allocation.

[Evaluation of information for renal insufficiency patients before dialysis]. / Evaluation de l'information aux patients insuffisants rénaux avant dialyse.

The aim of this audit was to assess the quality of information given to patients before dialysis and to improve the use of this information on the acceptability of the treatment. Methods were those used in medical audit: retrospective data collection in a sample of patients, comparison to a set of standards given by professionals and recommendations disseminated in the group of professionals. Results showed that patients received a partial information on the various techniques used in dialysis. More complete information is needed. Recommendations consisted in a specialised team giving a detailed information on the disease and the techniques used in dialysis, with a psychological assistance. After implementation of this team, re-assessment showed a consistent benefit of structured information and entailed the necessity to improve the process of information delivery by general practitioners and specialists.

Study of the variations of the cesarean sections rate in the Rhône-Alpes region (France): effect of women and maternity service characteristics.

OBJECTIVE: To analyze the variations of the rate of prophylactic cesarean sections and cesarean sections during labor according to the women's and maternity services' characteristics. STUDY DESIGN: The study population was a sample of 8470 women having delivered in one of the 86 maternity services of the Rhône-Alpes region (France) in 1990. The women's characteristics were risk factors for pregnancy or delivery. The maternity services' characteristics included those describing the service structure and the mode of recruitment. For the statistical analysis we used a two-level logistic model. RESULTS: After taking into account the women's characteristics, there remained a variation between the maternity services. This variation was in part explained by the type of recruitment of the maternity service. When the proportion of women with a previous cesarean section or a dystocia increased in the maternity service the cesarean sections rate decreased in women presenting similar characteristics. CONCLUSION: Thus, the maternity services which receive many "at risk" women tend to have higher cesarean section rates than the others. However, in comparison with women presenting similar characteristics, these same maternity services tend to perform fewer cesarean sections.

Including practice data to improve evidence-based guidelines. Example of guidelines on the management of thyroid nodules.

Although clinical guidelines are based on the best evidence available, their proliferation has often failed to change actual practice. One of the many explanations suggested is that there is a gap between the expectations of the targeted professionals and the recommendations in the guidelines. In this study, we attempted to take into account the state of current practice and the physicians' priorities. Using the example of guidelines on the management of thyroid nodules, three different surveys have been conducted: (1) an analysis of physicians' expectations and practice through a postal questionnaire to define appropriate questions; (2) a survey of the professionals' expert opinions, and (3) a prospective study of the use of these guidelines in the management of 253 patients. The results of these surveys have modified the development of the guidelines, and helped us to adapt the content of the guidelines to match physicians' practices more closely.

[Use of a logistic regression model at two levels in the analysis of medical practice variations: the prophylactic cesarean]. / Utilisation d'un modèle de régression logistique à deux niveaux dans l'analyse des variations de pratique médicale: à propos de la césarienne prophylactique.

We show the use of a hierarchical logistic model to study the variations of the prophylactic cesarean section rate between the maternity hospitals of the Rhône-Alpes region. These variations are analyzed according to the women characteristics at first level, and the maternity hospital characteristics at second level. We present the two-level hierarchical logistic model and the method of estimation of the fixed and random parameters. Then, we compare and discuss the results obtained with those of the usual logistic model. The usual logistic model underestimates the standard error of the regression parameters. In our example however, the results obtained with the hierarchical model do not modify the conclusions concerning the effect of the women characteristics. All the women characteristics increase significantly the probability for a woman to have a prophylactic cesarean section. Nevertheless, the hierarchical model reveals the effect of the maternity hospital characteristics and shows that the maternity hospitals which receive many "at risk" women tend to perform fewer prophylactic cesarean sections than the others, in women with the same characteristics. It permits to estimate the residual variance of second level linked to the unobserved characteristics of the maternity hospitals. It permits to show that the effect of the main characteristics of the women (previous cesarean section, dystocia, chronic fetal distress) vary between maternity hospitals.

[Report of the activity of ANDEM and outlook]. / Bilan de l'activité de l'ANDEM et perspectives.

ANDEM was created on February 7, 1990. A non profit organisation, the Agency has a Board of Administration and a Scientific Council. It has two principal missions: The setting up and the development of an evaluation process in the filed of medical technologies and strategies. For this purpose, the Agency develops clinical guidelines and participates in the organisation of consensus conferences, in full partnership with scientific societies and professional groups. Since 1994, the Agency has been involved in a program of medical recommendations and references. The development, both in hospitals and in ambulatory care, of programs evaluating quality of care using adapted and validated methods.