[From clinical observation to assessment of practices: guidelines for hypertension management]. / De l'observation clinique à l'évaluation des pratiques : les recommandations pour la prise en charge de l'hypertension artérielle.

Arterial hypertension is highly prevalent and one of the main risk factors for cardiovascular diseases. It has been demonstrated that antihypertensive treatment is effective to prevent cardiovascular events. Advances have been made in this field for 50 years and the knowledge and management of hypertension has been modified continuously with increase of related costs. Therefore hypertension is one of the favorite themes for guidelines and indeed several guidelines have been published on this theme regularly. Despite this, a high percentage of treated hypertensive patients remains uncontrolled. Several reasons have been raised for not implementing guidelines: these guidelines are often little-known because of their large number and their bad distribution. A systematic analysis of the last guidelines showed also they were structurally different with a small percentage of identical references and they provided sometimes different practical conclusions. Finally, clinical inertia is partly responsible for these insufficient results. As the current form of the guidelines has a limited impact on the medical practice, we should find other methods to improve their implementation.

Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.

BACKGROUND: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment. AIM: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies). PATIENTS AND METHODS: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire. RESULTS: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69-97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease. CONCLUSION: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.

[Prevalence and management of pain in a hospital: a cross-sectional study]. / Prévalence et prise en charge de la douleur à l'hôpital. Une étude transversale.

OBJECTIVES: Improved management of pain, particularly in inpatients, is a public health priority. We conducted this study to ascertain current practices and identify indications useful for measuring their impact. PATIENTS AND METHODS: A "given day" cross-sectional study was conducted in 18 units (11 medicine units and 7 surgery and obstetrics units) at the Cochin Hospital, Paris. All patients hospitalized over 24 hours were included in the study. A short one-page questionnaire was administered by an investigator (nurse or physician) after the patient agreed to participate in the study. All pertinent information concerning pain at admission and/or during the 24 hours of hospitalization (quantified on a simple verbal scale), percent pain relief compared with the initial level, and any circumstances leading to an increase in the pain level during hospitalization were recorded. Data were also collected on antalgesia prescription administered the day of the survey. Social and demographic data as well as discharge diagnosis(es) were also recorded. RESULTS: Nearly 60% of the patients stated they had experienced pain at the time of admission or during the 24-h preceding the survey. In medicine units, 29% of the inpatients with pain were not given any anti-pain treatment (this percentage was 12% in surgery) and 35% stated their pain had been relieved by less than 50% (13% of the patients in surgery). Hospitalization in a medicine unit was associated with fewer and less effective prescriptions in patients experiencing pain. CONCLUSION: Regular and simple indications, specifically the number of patients complaining of pain who have not been given an antalgesic, would provide the health care team with a measurement of pain management useful for assessing its impact and improving patient care.

Effects of financial incentives on medical practice: results from a systematic review of the literature and methodological issues.

OBJECTIVE: To identify all financial incentives that had been proposed, described, or used regardless of their initial objective and, when possible, to assess the results of these incentives on costs, process or outcomes of care. MATERIAL AND METHODS: Systematic review of the literature. Databases searched were: Medline, Embase, Health Planning and Administration, Pascal, International Pharmaceutical Abstracts and the Cochrane Library. Search terms were: health professionals and tape of practice, type of incentive, methodology, languages English or French, January 1993 to May 1999. RESULTS: Financial incentives concerned the modalities of physician payment and financing of the health care system. Confounding factors included: age of the doctor, training, speciality, place and type of medical practice, previous sanctions for over-prescribing, type and severity of disease, type of insurance. Risks of financial incentives were: limited access to certain types of care, lack of continuity of care, conflict of interests between the physician and the patient. Any form of fund-holding or capitation decreased the total volume of prescriptions by 0-24%, and hospital days by up to 80% compared with fee-for-service. Annual cap on doctors' incomes resulted in referrals to colleagues when target income is reached. DISCUSSION: Financial incentives can be used to reduce the use of health care resources, improve compliance with practice guidelines or achieve a general health target. It may be effective to use incentives in combination depending on the target set for a given health care programme.

Despite financial penalties, French physicians' knowledge of regulatory practice guidelines is poor.

OBJECTIVE: To evaluate the level of awareness and knowledge of regulatory practice guidelines (references medicales opposables [RMOs] or regulatory medical references) implemented to control ambulatory care costs among French family physicians. DESIGN: Observational study. Participants were asked to identify RMO topics among a list of actual and fictitious RMO topics and the RMOs themselves among a list of actual and fictitious RMOs. SETTING: General practice in France. SUBJECTS: Three hundred twenty-one family physicians. MAIN OUTCOME MEASURE: Average score of 100 (95% confidence interval [CI]) on the awareness of RMO topics and knowledge of the RMOs. RESULTS: The average overall score was 55.8 of 100 (95% CI, 53.3-58.3) for the awareness of the RMO topics and 50.5 (95% CI, 48.3-52.7) for knowledge of the RMOs themselves-53.2 (95% CI, 51.1-55.3) for diagnostic RMOs and 47.8 (95% CI, 45.6-50.0) for therapeutic RMOs. Chance would have yielded an expected mean score of 50. A statistically significant difference was noted between the average score for actual (62.2) and fictitious (43.2) RMOs, P<.001. None of the respondents correctly identified all 24 correct answers. CONCLUSION: Despite implementation of RMO policy, the awareness and knowledge of RMOs among French family physicians seem weak. The number of RMOs and the difficulties in controlling physicians probably explain these results. Thus, it is doubtful that the RMO policy will have a long-term effect on physicians' behavior.

From clinical recommendations to mandatory practice. The introduction of regulatory practice guidelines in the French healthcare system.

In an effort to control ambulatory care costs, regulatory practice guidelines (références médicales opposables or RMOs) were introduced by law in France in 1993. RMOs are short sentences, negatively formulated ("it is inappropriate to..."), covering medical and surgical topics, diagnosis, and treatment. Since their introduction, physicians who do not comply with RMOs can be fined. The fine is determined by a weighted combination of indices of harm, cost, and the number of violations. The impact of the RMO policy on physician practice has been questioned, but so far few evaluations had been performed. At the end of 1997, only 121 physicians had been fined (0.1% of French private physicians). The difficulty of controlling physicians, the large number of RMOs, and the lack of a relevant information system limit the credibility of this policy. The simultaneous development of a clinical guideline program to improve the quality of care and of a program to control medical practice can lead to a misunderstanding among clinicians and health policy makers. Financial incentives or disincentives could be used to change physician behavior, in addition to other measures such as education and organizational changes, if they are simple, well explained, and do not raise any ethical conflict. But these measures are dependent on the structure and financing of the healthcare system and on the socioeconomic and cultural context. More research is needed to assess the impact of interventions using financial incentives and disincentives on physician behavior.

From clinical guidelines to quality assurance: the experience of Assistance Publique-Hôpitaux de Paris.

OBJECTIVES: The objectives of this study are: to present the history of the development of clinical guidelines in France. to present the implementation of a program of clinical guidelines in Assistance Publique-Hôpitaux de Paris (AP-HP), the regional public hospital system of the Paris metropolitan area, and to discuss the lessons learned from this program, which provide a basis for a better policy of guidelines at a national level. CONTENT: The objective of the AP-HP program is to promote the appropriate use of clinical guidelines and to evaluate their impact on quality of care and/or costs. Experiments such as controlled trials are used to test the effectiveness of some implementation strategies, to verify that guidelines do improve the process of care and to improve physician compliance with clinical guidelines. Guidelines are developed in a context of budget constraint, and the general aim of the program is to promote the more efficient use of available health resources. RESULTS: In a context of health care inflation, the desire of public authorities is to use guidelines as a tool for cost control strategy, either for ambulatory care or for hospitals. AP-HP experience shows that it is very difficult to develop a national program of clinical guidelines and to implement it in every hospital, as was done in France (but not clearly evaluated) in ambulatory care (under the name 'references médicales'). Guidelines need to be locally adapted, and the best implementation strategies depend on local resources, for example the existence of a pertinent information system. The role of financial incentives is present in French policies, and the role of the drug industry needs to be evaluated.

Assessment of screening tests for transfusion-associated non-A non-B hepatitis.

Non-A non-B hepatitis is the most common serious sequela of blood transfusion, and its screening has become an essential goal of blood transfusion centers. Before 1989, two surrogate screening tests (for alanine aminotransferase and for antibody to hepatitis B core antigen) were used; in 1989, a direct test for the antibody to hepatitis C virus (the main agent of this hepatitis) was developed. The French National Agency for the Development of Medical Evaluation undertook an investigation to determine the optimal prevention strategy for posttransfusion non-A and non-B hepatitis (PTH). A detailed literature review was performed, complemented by expert group opinion. The performance of each test was derived indirectly by calculating the number of cases of PTH averted by each test. Hepatitis C virus testing is probably the most promising strategy, but different policies can be developed given the uncertainties of scientific data. Cost considerations should be taken into account in identifying the best screening strategy.

Examples of the influence of evaluation on health policy.

Regulation strategies for controlling hospital costs are widely discussed today and medical technology assessment is one of these strategies. A Committee for Evaluation of the Diffusion of Innovative Technologies (CEDIT) was created in 1982 at the 'Assistance Publique de Paris', the most important health care institution in France. The CEDIT makes recommendations to the Director General on the use of new technologies. Since 1982, more than 50 medical technologies have been studied by the CEDIT: procedures such as plasmapheresis, bone marrow transplantation and percutaneous transluminal angioplasty; equipment such as lasers and the lithotriptor. The CEDIT helps planners who have to make difficult choices.