Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

BACKGROUND: Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. METHODS: In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. RESULTS: Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care. CONCLUSION: There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.

Survey on sea snakebite and related morbidity and mortality among Bangladeshi fishermen in the Bay of Bengal: A pilot study.

Around two million people are engaged in marine fishing in the Bay of Bengal. Bites by sea snakes were common hazards feared by millions fishing at sea in earlier days. Current morbidity and mortality are also not known. This study was conducted to document and describe sea snake bites among selected communities of sea-going fishermen in Bangladesh. A questionnaire-based cross-sectional survey was conducted from May to October 2019 among three communities of sea-going fishermen living along the coast of the Bay of Bengal in Cox's Bazar district. Fishermen were first asked by trained interviewers to recall any sea snakebites to themselves and among their fellows on board within the last year, then within the last 5 years and at any time before that. For any bite, related information including outcome was noted. Overall, 25.4% of respondents (62 out of 244) had been bitten by sea-snakes. Mean age was 37.6(±14) years; all males. 51.6% received some sort of treatment locally; 71% hot compress and 48% tourniquets. In 80.6% the affected limb was not immobilized. The bitten site was incised in 29%. 22.6% received treatment from traditional healers, 48.4% from local hospitals, 29% from district hospital. Six victims (9.7%) suffered from severe life-threatening consequences of the sea snakebite but none died. 32% of the fishermen had seen the offending snake. Sea snakebites are potentially dangerous; therefore, educating fishermen to avoid contact with sea snakes would dramatically reduce the incidence of sea snakebites. Most bites are treated initially by local measures which are often not scientific. Provision of proper first aid and treatment might reduce mortality and morbidity. A larger survey on sea snake bites among the fishermen in all coastal areas of Bangladesh is needed to determine the nationwide burden of morbidity and mortality related to sea snakebite.