Chapitre 2. L'autonomisation des comités nationaux d'éthique de la recherche en Afrique : perspective historique et enjeux actuels.

Since the 60s, and particularly after various scandals in the 90s, national research ethics committees in Africa have established themselves as key players in the field of international clinical research. Notably based on the principle of double ethical review, their existence has historically been aimed at preventing a form of ethical dumping, a temptation that still exists today on the part of some research promoters. While the international framework of “soft” law has favored their emergence and legitimacy, a legal and regulatory framework of “hard” law is also necessary at local level for each national research ethics committee, to ensure its proper functioning and the optimal fulfillment of its missions. The aim of this article is to analyze the similarities and differences between three national ethics committees in Africa, specifically the CNERS of Guinea, the CNERS of Benin and the CNESVS of Côte d’Ivoire, in terms of status, missions, legal or regulatory ground and, more generally, autonomy. This analysis will enable us, on the one hand, to take account of common logistical difficulties and, on the other, to go beyond differences in legal status and missions to define what enables this type of committee to fully exercise its role(s). Finally, this article proposes to model the various elements that contribute to the autonomy and resilience of a national research ethics committee, around a notion proposed on this occasion: the “circles of autonomy”.

Assessing allergic rhinitis in developing countries.

BACKGROUND: Allergic rhinitis (AR) affects 5% to 40% of the general population. In developing countries, AR is poorly documented and tracked due to a lack of appropriate diagnostic tools. OBJECTIVE: 1) To validate a questionnaire standardised in industrialised countries to ascertain AR, the Score For Allergic Rhinitis (SFAR), in developing countries; 2) to better understand AR prevalence previously reported from developing countries by comparing results from the SFAR and the International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires. METHODS: Six African countries were selected for their climates. In each country, 70 individuals with and 30 without nasal symptoms filled out the SFAR and the ISAAC questionnaires. Skin prick tests (SPTs) for allergens were performed by the physician if necessary. RESULTS: The SFAR presented a close match with the gold standard (the physician's diagnosis of AR backed up by SPT where necessary) in terms of various performance parameters. In particular, it showed high sensitivity (0.84) and specificity (0.81). Compared to the ISAAC questionnaire, the SFAR had greater sensitivity and equal specificity. CONCLUSIONS: In the absence of a medical visit, the SFAR is a useful standardised screening instrument for the collection of information needed for the identification of AR in developing countries.

[Impact of care pathway on the delay for initiation of antituberculosis treatment in Conakry, Guinea]. / Influence des parcours de soins sur le début du traitement antituberculeux à Conakry (Guinée).

Complex care pathways can result in detrimental treatment delay particularly in tuberculosis patients. The purpose of this retrospective study was to assess the care pathways followed by tuberculosis patients prior to diagnosis and to assess impact on the delay for initiation of treatment in Conakry, Guinea. A total of 112 patients were interviewed at the time of first admission for pulmonary tuberculosis with positive bacilloscopy. Based on interview data, pathways were classified as conventional (use of health care facilities only) and mixed (use of health care facilities, self-medication, and traditional medicine). The correlation between patient characteristics and type of pathway was assessed by univariate and multivariate analysis and the two groups, i.e., conventional vs. mixed, were compared with regard to delay for initiation of treatment. The care pathway was classified as mixed in two out of three patients. Multivariate analysis showed that this type of pathway was only correlated with schooling (p=0.02). The mean delay for treatment was similar, i.e., 13.4 and 12.8 weeks for conventional and mixed pathways respectively (p<0.68). The percentage of pathways including three consultations at health care facilities was significantly higher in the conventional than mixed group (72% vs. 30%, p<0.001). The main reasons given for delayed use of health care facilities were poor knowledge of tuberculosis symptoms (26%) and high cost of care (12%). The findings of this study indicate that tuberculosis patients follow a variety of care pathways that can lead to delayed treatment. An information campaign is needed to increase awareness among the population and care providers.

Influence des parcours de soins sur le debut du traitement antituberculeux a Conakry (Guinee)

Les parcours de soins sont souvent complexes et peuvent induire des retards de traitement; avec des effets particulierement deleteres en cas de tuberculose. Nous avons cherche a identifier de facon retrospective; les parcours de soins des patients avant le diagnostic de tuberculose et l'influence de ces parcours sur les delais de traitement a Conakry-Guinee.Nous avons interroge 112 nouveaux patients a leur enregistrement pour tuberculose pulmonaire a bacilloscopie positive. Ont ete distingues les parcours conventionnels (recours aux seules structures sanitaires) et mixtes (associant structures sanitaires; automedication et medecine traditionnelle). L'influence des caracteristiques des patients sur le type de parcours a ete testee en analyses uni et multivariees et les delais de mise sous traitement ont ete compares pour les deux types de parcours. Deux patients sur trois ont suivi un parcours mixte. Ce type de parcours n'etait lie; en analyse multivariee; qu'au niveau de scolarisation (p=0;02). Les delais moyens de traitement etaient similaires (respectivement 13;4 et 12;8 semaines pour les parcours conventionnels etmixtes; p=0;68). La proportion de parcours comportant plus de trois recours aux structures sanitaires etait significativement plus elevee pour les parcours conventionnels que pour les parcours mixtes (72vs 30; p0;001). Les principales raisons invoquees pour l'utilisation tardive des structures sanitaires etaient l'ignorance des signes de la tuberculose (26) et le cout eleve des soins (12). Les parcours des patients sont multiples et peuvent induire des retards a la mise sous traitement antituberculeux. Une sensibilisation de la population et des soignants est necessaire

Associated tuberculosis and diabetes in Conakry, Guinea: prevalence and clinical characteristics.

SETTING: Anti-tuberculosis centres in Conakry. OBJECTIVES: To determine the prevalence of diabetes mellitus in patients with tuberculosis (TB), identify the associated risk factors and describe the clinical signs of the association of TB and diabetes. METHOD: A total of 388 patients with TB selected by simple random sampling from the register of cases diagnosed in Conakry were examined and administered a capillary blood glycaemia test to detect diabetes. RESULTS: Thirteen cases of diabetes were identified, giving a prevalence rate of 3.35% (95%CI 1.35-5.35). Four (31%) had not been diagnosed before the survey. The diagnosis of diabetes preceded that of TB by an average of 5 years (range 1-9 years). The clinical characteristics of TB (frequent exposure to infection, site and proportion of new and retreated cases) did not differ from one group to another. Increased age (P < 0.0001), obesity (P < 0.005), sedentary lifestyle (P < 0.0004), and previous family history of diabetes (P = 0.04) or obesity (P = 0.04) were significantly associated with diabetes. CONCLUSION: The prevalence of diabetes among TB patients is higher than previously estimated for Guinea. Because of frequent co-morbidity, systematic testing for diabetes among TB patients may be recommended, particularly if risk factors are present.

Investigation of the risk factors for tuberculosis: a case-control study in three countries in West Africa.

BACKGROUND: Host-related and environment-related factors have been shown to play a role in the development of tuberculosis (TB), but few studies were carried out to identify their respective roles in resource-poor countries. METHODS: A multicentre case-control study was conducted in Guinée, Guinea Bissau, and The Gambia, from January 1999 to March 2001. Cases were newly detected smear positive TB patients. Two controls were recruited for each case, one within the household of the case, and one in the community. RESULTS: Regarding host-related factors, univariate analysis by conditional logistic regression of 687 matched pairs of cases and household controls showed that TB was associated with male sex, family history of TB, absence of a BCG scar, smoking, alcohol, anaemia, HIV infection, and history and treatment of worm infection. In a multivariable model based on 601 matched pairs, male sex, family history of TB, smoking, and HIV infection were independent risk factors of TB. The investigation of environmental factors based on the comparison of 816 cases/community control pairs showed that the risk of TB was associated with single marital status, family history of TB, adult crowding, and renting the house. In a final model assessing the combined effect of host and environmental factors, TB was associated with male sex, HIV infection, smoking (with a dose-effect relationship), history of asthma, family history of TB, marital status, adult crowding, and renting the house. CONCLUSION: TB is a multifactorial disorder, in which environment interacts with host-related factors. This study provided useful information for the assessment of host and environmental factors of TB for the improvement of TB control activities in developing countries.

Investigation of environmental and host-related risk factors for tuberculosis in Africa. I. Methodological aspects of a combined design.

Host-related and environmental factors for tuberculosis have usually been investigated separately using different study designs. Joint investigation of the genetic, immunologic, and environmental factors at play in susceptibility to tuberculosis represents an innovative goal for obtaining a better understanding of the pathogenesis of the disease. In this paper, the authors describe methods being used to investigate these points in a West African study combining several designs. Patients with newly diagnosed smear-positive cases of tuberculosis are recruited. The effect of host-related factors is assessed by comparing each case with a healthy control from the case's household. The role of environmental factors is estimated by comparing cases with randomly selected community controls. The frequencies of candidate gene variants are compared between cases and community controls, and results are validated through family-based association studies. Members of the households of cases and community controls are being followed prospectively to determine the incidence of "secondary" tuberculosis and to evaluate the influence of geographic and genetic proximity to the index case. This type of design raises important methodological issues that may be useful to consider in studies investigating the natural history of infectious diseases and in attempts to disentangle the effects of environmental and genetic factors in response to infection.

Investigation of environmental and host-related risk factors for tuberculosis in Africa. II. Investigation of host genetic factors.

In an accompanying paper (Am. J. Epidemiol. 2002;155:1066-73), the authors describe the design of a large multicenter study being carried out in three West African countries for investigation of the roles of environmental and host-related factors in the development of tuberculosis. In this paper, the authors review some evidence that host genetic factors play a role in susceptibility to tuberculosis. They describe the three components of the study that are designed to investigate the effect of host genetic factors on the development of tuberculosis: case-control and family-based association studies of candidate genes and analysis of affected relative pairs to screen the human genome for areas of linkage to the disease. The authors also address a number of methodological issues that arise, such as the effects of consanguinity, half-siblings, and nonpaternity. Lastly, they review opportunities to assess gene-environment interaction in the framework of the study, in light of current methodological knowledge. Consideration of these issues may be useful in the design of other studies of genetic susceptibility to infectious diseases, particularly those to be carried out in developing countries.