[Patients' contribution to the review of research protocols]. / L'apport des patients dans la relecture des protocoles de recherche.

Involvement of patients in the ethical management of research protocols began by patients' associations involved in the fight against AIDS in France in the 1990s. It was the first step towards recognizing the major role of patients in research that concerns them. This article aims describing this emancipation and its consequences on the evolution of research by drawing on two experiences: 1) The one of the « Comité de patients pour la recherche clinique ¼ founded in 1998 by the « Ligue nationale contre le cancer ¼ and by the « Fédération nationale des centres de lutte contre le cancer ¼; 2) The one of the « Collège des relecteurs de l'Inserm ¼ set up in 2007.

Title: L'apport des patients dans la relecture des protocoles de recherche. Abstract: L'implication des patients dans la gestion éthique des protocoles de recherche, débutée en France dans les années 1990 par les associations de malades impliquées dans la lutte contre le syndrome de l'immunodéficience acquise (sida), a été le premier pas qui a permis de reconnaître le rôle essentiel des patients dans les recherches les concernant. Nous présentons dans cet article cette émancipation et ses conséquences sur l'évolution de la recherche, en s'appuyant sur une double expérience : celle du comité de patients pour la recherche clinique, créé en 1998 par la Ligue nationale contre le cancer et par la fédération nationale des centre de lutte contre le cancer, puis celle du Collège des relecteurs mis en place par l'Inserm en 2007.

Imperfect biomarkers for adjuvant chemotherapy in early stage breast cancer with good prognosis.

The proliferation of biomarkers has raised concerns regarding the possibility for clinical judgment to be improperly removed from clinician's jurisdiction and included in laboratory tests. To evaluate the ways in which the diffusion of biomarkers questions the autonomy of clinicians, we consider the case of chemotherapy prescription to women with early stage breast cancer and a good prognosis. Drawing on a qualitative study of clinicians working in a diversity of institutional contexts, we follow three biomarkers available to guide this routinely made decision. We show that, biomarkers able to reduce all the uncertainties associated with, what we analyse as an uncomfortable decision, are sought more than dreaded by clinicians. If such ideal tools are unavailable, the fact is well acknowledged by the profession. Rather than precluding their usage, the imperfection of existing biomarkers is controlled by the profession, through their integration as additional tools in the decision process. The fact that the biomarkers are recognized as imperfect biomedical entities reinforces the importance of local material, organizational and financial constraints over that of international science, technology and clinical data, in their diffusion. The regulation of the uncertainties associated with these imperfections is organized at the professional level. Through an important work, relying on guidelines and enforced in collective bodies, the series of heterogeneous bioclinical evidences available are articulated. Biomarkers tend to be subordinated to the clinic. While maintaining the professional autonomy, the process also strengthens the internal professional hierarchy. When the most expert clinicians manage to inhabit a space for clinical autonomy, the nonexpert are torn between stronger professional rules and patient preferences. In this alliance between biomarkers and experts, their clinical autonomy tends to be the price for the professional autonomy.

The family accompaniment of persons with dementia seen through the lens of the capability approach.

Using the capability approach initially developed by A Sen as a theoretical framework, this paper analyses both what people with dementia and their families do in response to difficulties in their daily life brought about by the disease, and the reasons they give for acting as they do. Individual and collective interviews and ethnographic observations with 15 persons with dementia and one or more of their family members were conducted. Follow-up interviews were possible for nine families. Results highlight a great diversity in ways of doing things and in accompaniment by family members. Daily adjustments are often hidden or minimized, at least at the onset of the dementia. Later, they become more frequent, repetitive and indispensable but remain influenced by the social and gender roles that existed prior to the illness. The inventiveness of families, in a context marked by various kinds of constraints, is primarily motivated by their desire to maintain the apparently intact abilities of the person with dementia but especially to preserve forms of liberty and what counted for the person, what that person valued before the disease. There are some ways of living with dementia, even when accompanied, which may long remain preferable to others, which better answer to the past and present aspirations of persons with dementia and the purposes of the accompanying persons. It is thus essential that health professionals, as well as society in general, recognize and address this issue.

Capability deprivation of people with Alzheimer's disease: An empirical analysis using a national survey.

How can one assess the quality of life of older people--particularly those with Alzheimer's disease--from the point of view of their opportunities to do valued things in life? This paper is an attempt to answer this question using as a theoretical framework the capability approach. We use data collected on 8841 individuals above 60 living in France (the 2008 Disability and Health Household Survey) and propose a latent variable modelling framework to analyse their capabilities in two fundamental dimensions: freedom to perform self-care activities and freedom to participate in the life of the household. Our results show that living as a couple, having children, being mobile and having access to local shops, health facilities and public services enhance both capabilities. Age, household size and male gender (for one of the two capabilities) act as impediments while the number of impairments reduces both capabilities. We find that people with Alzheimer's disease have a lower level and a smaller range of capabilities (freedom) when compared to those without, even when the latter have several impairments. Hence they need a special attention in policy-making.

[Involvement of researchers with patient associations: what is the role of their opinions, their clinical activity and their nature?]. / Engagement des chercheurs auprès des associations - Quel rôle jouent leurs opinions, leur activité clinique et leur genre ?

Although the involvement of patient associations in biomedical research is well known, conversely, researchers' views and perceptions of these associations have remained unknown. For this reason, Inserm's Patients' Association Liaison Group (GRAM) launched the CAIRNET survey in 2012, based on questionnaires and interviews conducted with researchers working at Inserm. The variety of their opinions made it possible to distinguish four profiles, the committed, the pragmatic, the reticent and the distant. Thus 41 % of respondents reported ongoing relationships with at least one association, 72 % for the committed and 16 % for the distant. Although these relationships are formed more easily among researchers involved in clinical activity, they also encourage collaborations between clinicians and basic researchers. The apparently lower degree of involvement of female researchers proved to be associated with a lower level of clinical activity, limited permanent recruitment, and a lower hierarchical status.

[Role of research institutions in management of scientific fraud: The example of Inserm Scientific Integrity delegation]. / Rôle des institutions dans la gestion de la fraude scientifique : l'exemple de la Délégation à l'intégrité scientifique de l'Inserm.

Fraud is only a part of misconduct in research. Very few French research Institutions have a scientific integrity office, and their prevention. The Institut national de la santé et de la recherche médicale (Inserm) has created a "Scientific Integrity delegation". Scientific Integrity is an international concern. Scientific Integrity is closely linked to organisation, management and evaluation of all research activities.

General practitioners' role in cancer care: a French-Norwegian study.

BACKGROUND: In cancer care, a GP's work is rarely defined clearly. Our aim was to assess GPs' work with cancer patients in France and in Norway, where the roles of the GP and the organization of the system are rather different. FINDINGS: A questionnaire with 40 closed-ended questions about GP involvement in diagnosis, treatment, follow-up and terminal care was constructed and mailed to samples of GPs. The patients had seen the doctor at least once over the past year. In France 1679 and in Norway 386 individual patient questionnaires were completed. GPs have a major role in the diagnosis of cancer, and this role varies according to cancer type. The GPs participated actively in different phases of follow-up after cancer treatment. Low response rates do not allow direct comparison between countries, but higher PSA screening rates in France seem to increase the percentage of patients diagnosed after screening rather than after a clinical suspicion. Interaction between GPs and specialists during cancer treatment and follow-up was important in both countries. CONCLUSION: Both in France and in Norway GPs participate actively in cancer care. Early clinical diagnosis is a challenge. More research is needed about how GPs can improve their early diagnostic work. Organisational issues may influence cancer responsibilities for the GP, and national health systems should be challenged to look at possible new roles for GPs in cancer care. Medical training, both pre- and post-graduate, should prepare doctors for collaboration between primary and secondary care, particularly important in cancer care.

[Perspectives of general practitioners on the role of patients' caregivers in the process of consultation and treatment]. / Représentations par les médecins généralistes du rôle de l'entourage accompagnant le patient.

The aim of this study is to describe, from the perspective of general practitioners, the role of relatives and caregivers who accompany a patient in their consultation and treatment processes. 435 general practitioners filled out two questionnaires: the first was self administered and the second described specific clinical situations and the possible role of the family caregiver in the case of a patient with Alzheimer's diseases, Parkinson's disease, depression, epilepsy, asthma, cardiovascular disease, or type II diabetes. General practitioners think that overall they offer satisfactory responses to relatives' requests and concerns regarding the disease itself and its treatment. However, they do not feel skilled or qualified enough to answer them with regard to administrative or social questions. The relative's role is for the most part, perceived as positive, and seems to contribute to the efficacy of the care provided. This description corresponds to a new trend in modern medical practice, dominated by the burden of chronic and disabling diseases which implies, and in some cases requires, the need to involve a relative's presence and on-going support.

Influenza burden of illness: estimates from a national prospective survey of household contacts in France.

BACKGROUND: The burden of influenza among ambulatory patients is still relatively unknown, although this knowledge is crucial for evaluating strategies against influenza. We estimated the impact of influenza in terms of uncomplicated morbidity and its consequences on health care utilization and lost workdays. METHODS: A national prospective household contact study between January 4, 2000, and March 15, 2000, in France recruited the households of 946 persons who visited a physician (index cases); 395 households with influenza-positive index cases completed the follow-up, which assessed the clinical impact of influenza, medical visits, treatment, and lost workdays in these index cases and their contacts. RESULTS: Of 817 assessable household contacts, 313 developed clinical influenza (secondary cases); 178 (57%) of them visited a physician at least once (consulting secondary cases). The median duration of illness was 8 days (95% confidence interval [CI], 7-8 days) in index cases, 7 days (95% CI, 7-8 days) in consulting secondary cases, and 4 days (95% CI, 3-5 days) in nonconsulting secondary cases (P<.001); the median duration of treatment in these groups was 8 days (95% CI, 8-9 days), 8 days (95% CI, 7-10 days), and 5 days (95% CI, 4-6 days), respectively (P<.001); and their mean +/- SD number of lost workdays was 4.0 +/- 2.8, 2.9 +/- 2.5, and 0.3 +/- 0.6, respectively, in working adults (P<.001). CONCLUSIONS: These results confirm the substantial burden of illness of influenza. The results should be useful for evaluating the cost-effectiveness of strategies against influenza.