Perspectives of buruli ulcer patients toward informed consent - An insight from Nigeria.

Introduction: Informed consent is a basic ethical requirement in situations involving sharing of patients' data. It supports and upholds the ethical principle of respect for persons and individual autonomy. For Buruli ulcer (BU) patients, associated stigma renders them vulnerable, hence the need for emphasis on additional protection by ensuring obtaining informed consent before third party use of their data. The authors therefore sought to determine willingness of these patients to give informed consent to the third party use of their data before and after treatment. Methodology: This cross-sectional study was carried out between February and August, 2019. The study involved BU patients from three endemic states in Nigeria. Data were collected using pretested, researcher-administered semi-structured questionnaires. Results: A total of 92 respondents participated in the study. The median age was 23.5 years (range 4-74 years) with the age group <15 years being the modal age group 36 (39.13%). About a quarter of the respondents (23.91%) had suffered some form of discrimination in the course of their disease. Majority 86 (93.48%) were favorably disposed to allowing the use of their data for donor drive, policy development, and teaching/training purposes. A significant greater proportion of respondents 90 (97.83%) were willing to give consent for the use of their oral interview as against pictures and videos both in the pre- and post-treatment periods. Conclusion: The present study provides evidence that majority of the respondents were positively inclined to give consent to use of their data by a third party. However, intrusion into privacy and anonymity were major concerns for the respondents.

RésuméIntroduction: Le consentement éclairé est une exigence éthique de base dans les situations impliquant le partage des données des patients. Il soutient et défend le principe éthique du respect des personnes et de l'autonomie individuelle. Pour les patients atteints d'ulcère de Buruli, la stigmatisation associée les rend vulnérables, d'où la nécessité de mettre l'accent sur une protection supplémentaire en garantissant l'obtention d'un consentement éclairé avant l'utilisation par des tiers de leurs données. Les auteurs ont donc cherché à déterminer la volonté de ces patients de consentir en connaissance de cause à l'utilisation de leurs données par des tiers avant et après le traitement. Les méthodes: Cette étude transversale a été réalisée entre février et août 2019. L'étude a porté sur des patients atteints d'ulcère de Buruli provenant de trois États endémiques du Nigéria. Les données ont été recueillies à l'aide de questionnaires semi-structurés prétestés et administrés par des chercheurs. Résultats: Au total, 92 répondants ont participé à l'étude. L'âge médian était de 23,5 ans (de 4 à 74 ans), le groupe d'âge <15 ans étant le groupe d'âge modal 36 (39,13%). Environ un quart des répondants (23,91%) ont subi une forme de discrimination au cours de leur maladie. La majorité 86 (93,48%) étaient favorables à autoriser l'utilisation de leurs données à des fins de mobilisation des donateurs, d'élaboration de politiques et d'enseignement / formation. Une proportion significativement plus élevée de répondants 90 (97,83%) étaient disposés à donner leur consentement pour l'utilisation de leur entretien oral par rapport aux photos et vidéos à la fois avant et après le traitement. Conclusion: La présente étude prouve que la majorité des répondants étaient positivement enclins à consentir à l'utilisation de leurs données par un tiers. Cependant, l'intrusion dans la vie privée et l'anonymat étaient des préoccupations majeures pour les répondants.

Evaluation of pulmonary tuberculosis case detection improvement with the deployment of XpertMTB/Rif in the tuberculosis control program of cross River State, Nigeria.

OBJECTIVE/BACKGROUND: Global indices show that Nigeria has the highest tuberculosis (TB)-related mortality rate. Overdependence on Ziehl-Neelsen (ZN) smear microscopy for diagnosis and human immunodeficiency virus (HIV)/AIDS has limited control efforts. The new polymerase chain reaction-based XpertMTB/Rif (Cepheid Inc., CA, USA), which detects Mycobacterium tuberculosis and rifampicin resistance, was introduced in Cross River State in 2014. We evaluated the increment in pulmonary TB case detection following introduction of XpertMTB/Rif into the Cross River State TB control program. MATERIALS AND METHODS: Data from three XpertMTB/Rif centers in Cross River were prospectively collected from June 2014 to December 2015. One spot specimen and one early morning sputum specimen were collected from each patient and tested using microscopy while one specimen was used for XpertMTB/Rif. RESULTS: A total of 2326 patients comprising 47.4.0% (1103) males and 52.6% (1223) females were evaluated. Their mean age was 38.8 years (range 4-89 years); 42.6% (991) were HIV positive and 50.9% (1183) HIV negative, and for 6.5% (158) HIV status was unknown. XpertMTB/Rif detected M. tuberculosis in 22.9% (534) of patients, while 16.8% (391) were ZN smear positive. Smear microscopy missed 24.5% (131/534) of cases (P < 0.0001). When patients where categorized according to HIV status, XpertMTB/Rif detected 23.7% (280/1183) and ZN smear microscopy detected 18.5% (219/1183) of HIV-negative patients. XpertMTB/Rif detected 21.5% (213/991) and ZN smear 14.1% (140/991) of HIV-positive patients. TB case detection was significantly higher in HIV-negative patients than in HIV-positive patients when either XpertMTB/Rif and/or ZN was used (P = 0.018 and 0.012, respectively). CONCLUSION: The use of XpertMTB/Rif has significantly increased TB case detection and data in Cross River State. Scale-up of additional strategies such as culture is still required to improve TB detection in HIV patients.

Financial burden of health care for Buruli ulcer patients in Nigeria: the patients' perspective.

BACKGROUND: The economic burden of Buruli ulcer for patients has not been well-documented. This study assessed the costs of Buruli ulcer care to patients from the onset of illness to diagnosis and to the end of treatment. METHODS: This was a cross-sectional cost of illness study conducted among patients with Buruli ulcer in four States in Nigeria between July and September 2015. A structured questionnaire was used to collect data on the patients' characteristics, household income and out-of-pocket costs of care. RESULTS: Of 92 patients surveyed, 54 (59%) were older than 15years, 49 (53%) were males, and 86 (93%) resided in a rural area. The median (IQR) direct medical and non-medical cost per patient was US$124 (50-282) and US$3 (3-6); corresponding to 149% and 4% of the patients' median monthly household income, respectively. The overall direct costs per patient was US$135 (58-327), which corresponded to 162% of median monthly household income, with pre-diagnosis costs accounting for 94.8% of the total costs. The direct costs of Buruli ulcer care were catastrophic for 50% of all patients/households - the rates of catastrophic costs for Buruli ulcer care was 66% and 19% for patients belonging to the lowest and highest income quartiles, respectively. CONCLUSIONS: Direct costs of Buruli ulcer diagnosis and treatment are catastrophic to a substantial proportion of patients and their families.

Evaluation of rifampicin resistance and 81-bp rifampicin resistant determinant region of rpoB gene mutations of Mycobacterium tuberculosis detected with XpertMTB/Rif in Cross River State, Nigeria.

OBJECTIVE/BACKGROUND: World Health Organization tuberculosis (TB) indices from 2014 to 2016 showed that Nigeria had the 6th highest prevalence, 4th highest incidence, and the highest mortality rate globally. In efforts to improve TB care, the XpertMTB/Rif (GeneXpert) technology, Cepheid, Sunnyvale, California, USA, which has revolutionized TB detection with concomitant rifampicin-resistance molecular detection, was introduced in Cross River State, South-South Nigeria, in 2014. The GeneXpert uses molecular beacons to detect five overlapping 81-bp regions in the rpoB gene known as the Rifampicin Resistant Determinant Region (RRDR). These probes are represented as Probe A (507-511), Probe B (512-518), Probe C (518-523), Probe D (523-529), and Probe E (529-533). Mutations in this region have been shown to account for about 93% of resistance to rifampicin, which is the most important drug in tuberculosis treatment. The objective of this study was to determine the frequency of rifampicin resistance and the commonly associated probes for various rpoB gene mutations within the 81-bp RRDR of Mycobacterium tuberculosis in Cross River State, Nigeria. METHOD: We collated and analyzed data from the 10 Xpert MTB/Rif sites in Cross River State from June 2014 to June 2016 and determined the frequency of mutations associated with different probes designated A-E, which represent the RRDR of rpoB gene. All centers use XpertMTB/Rif version G4. RESULT: In total, 973 tuberculosis cases were detected from 4671 cases tested. Rif resistance was detected in 6.0% (58/973) of cases. Probe E mutations were the most common, seen in 60.3% (35/58); followed by Probe D, 17.2% (10/58); and Probe B, 13.8% (8/58). Probe A occurred in 3.4% (2/58). No Probe C mutation was seen. Multiple mutation combinations involving probes B and D occurred in 3.4% (2/58), while one isolate had triple site mutations involving A, D, and E. One isolate that at initial testing showed a Probe A mutation displayed a Probe D mutation when tested in another site prior to treatment enrollment. CONCLUSION: In our setting, 6.0% of tuberculosis isolates are rifampicin resistant. Mutations associated with probe E commonly due to codon 531 are the most predominant cause of rifampicin resistance. Mutations at probe C (codons 518-523) were uncommon. A change in mutation may have occurred in one of the patients.