Verbal autopsy of 48 000 adult deaths attributable to medical causes in Chennai (formerly Madras), India

BACKGROUND: In the city of Chennai, India, registration of the fact of death is almost complete but the cause of death is often inadequately recorded on the death certificate. A special verbal autopsy (VA) study of 48 000 adult deaths in Chennai during 1995–97 was conducted to arrive at the probable underlying cause of death and to measure cause specific mortality rates for Chennai. METHODS: Trained non-medical graduates with at least 15 years of formal education interviewed the surviving family members or an associate of the deceased to write a report on the complaints, symptoms, signs, duration and treatment details of illness prior to death. Each report was reviewed centrally by two physicians independently. The reliability was assessed by comparing deaths attributed to cancer by VA with records in Vital Statistics Department and Chennai Cancer Registry. RESULTS: The VA reduced the proportion of deaths attributed to unspecified medical causes and unknown causes from 37% to 7% in early adult life and middle age (25–69 yrs) and has yielded fewer unspecified causes (only 10%) than the death certificate. The sensitivity of VA to identify cancer was 94% in the age group 25–69. CONCLUSION: VA is practicable for deaths in early adult life or middle age and is of more limited value in old age. A systematic program of VA of a representative sample of deaths could assign broad causes not only to deaths in childhood (as has previously been established) but also to deaths in early adult life and middle age

Understanding and retention of the informed consent process among parents in rural northern Ghana

<p>Abstract</p> <p>Background</p> <p>The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings. Parental informed consent process in a rural setting of northern Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing informed consent process.</p> <p>Methods</p> <p>The study involved 270 female parents who gave consent for their children to participate in a prospective cohort study that evaluated immune correlates of protection against childhood malaria in northern Ghana. A semi-structured interview with questions based on the informed consent themes was administered. Parents were interviewed on their comprehension and retention of the process and also on ways to improve upon the existing process.</p> <p>Results</p> <p>The average parental age was 33.3 years (range 18–62), married women constituted a majority (91.9%), Christians (71.9%), farmers (62.2%) and those with no formal education (53.7%). Only 3% had ever taken part in a research and 54% had at least one relation ever participate in a research. About 90% of parents knew their children were involved in a research study that was not related to medical care, and 66% said the study procedures were thoroughly explained to them. Approximately, 70% recalled the study involved direct benefits compared with 20% for direct risks. The majority (95%) understood study participation was completely voluntary but only 21% recalled they could withdraw from the study without giving reasons. Younger parents had more consistent comprehension than older ones. Maternal reasons for allowing their children to take part in the research were free medical care (36.5%), better medical care (18.8%), general benefits (29.4%), contribution to research in the area (8.8%) and benefit to the community (1.8%). Parental suggestions for improving the consent process included devoting more time for explanations (46.9%), use of the local languages (15.9%) and obtaining consent at home (10.3%).</p> <p>Conclusion</p> <p>Significant but varied comprehension of the informed consent process exists among parents who participate in research activities in northern Ghana and it appears the existing practices are fairly effective in informing research participants in the study area.</p

Gastric and intestinal barrier impairment in tropical enteropathy and HIV: limited impact of micronutrient supplementation during a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Although micronutrient supplementation can reduce morbidity and mortality due to diarrhoea, nutritional influences on intestinal host defence are poorly understood. We tested the hypothesis that micronutrient supplementation can enhance barrier function of the gut.</p> <p>Methods</p> <p>We carried out two sub-studies nested within a randomised, double-blind placebo-controlled trial of daily micronutrient supplementation in an urban community in Lusaka, Zambia. In the first sub-study, gastric pH was measured in 203 participants. In the second sub-study, mucosal permeability, lipopolysaccharide (LPS) and anti-LPS antibodies, and serum soluble tumour necrosis factor receptor p55 (sTNFR55) concentrations were measured in 87 participants. Up to three stool samples were also analysed microbiologically for detection of asymptomatic intestinal infection. Gastric histology was subsequently analysed in a third subset (n = 37) to assist in interpretation of the pH data. Informed consent was obtained from all participants after a three-stage information and consent process.</p> <p>Results</p> <p>Hypochlorhydria (fasting gastric pH > 4.0) was present in 75 (37%) of participants. In multivariate analysis, HIV infection (OR 4.1; 95%CI 2.2-7.8; <it>P </it>< 0.001) was associated with hypochlorhydria, but taking anti-retroviral treatment (OR 0.16; 0.04-0.67; <it>P </it>= 0.01) and allocation to micronutrient supplementation (OR 0.53; 0.28-0.99; <it>P </it>< 0.05) were protective. Hypochlorhydria was associated with increased risk of salmonellosis. Mild (grade 1) gastric atrophy was found in 5 participants, irrespective of <it>Helicobacter pylori </it>or HIV status. Intestinal permeability, LPS concentrations in serum, anti-LPS IgG, and sTNFR55 concentrations did not differ significantly between micronutrient and placebo groups. Anti-LPS IgM was reduced in the micronutrient recipients (<it>P <</it>0.05).</p> <p>Conclusions</p> <p>We found evidence of a specific effect of HIV on gastric pH which was readily reversed by anti-retroviral therapy and not mediated by gastric atrophy. Micronutrients had a modest impact on gastric pH and one marker of bacterial translocation.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN31173864</p

Potential for use of retinoic acid as an oral vaccine adjuvant

M.M.-L. is funded by the Bill & Melinda Gates Foundation

Vitamin a supplementation does not affect infants' immune responses to polio and tetanus vaccines.

It has been suggested that administering vitamin A with the measles vaccine may reduce the vaccine's immunogenicity. This trial examined the effect of supplementing vitamin A during the early months of life on infants' immune responses to tetanus and polio vaccines. Young infants (n = 1085) were enrolled and individually randomized into 1 of 4 groups in a factorial, double-blind, placebo-controlled trial. Three vitamin A supplementation strategies were investigated: 1) supplementation of breast-feeding mothers with 60 mg retinol equivalent (RE) vitamin A within 4 wk of delivery; 2) Expanded Program on Immunization (EPI)-linked supplementation of infants with 7.5 mg RE vitamin A at 6, 10, and 14 wk; and 3) combined mother and child supplementations. A 4th group in which mother and child were given placebos served as controls. Blood samples were collected from each child at 6 wk and 6 mo of age to measure antipolio antibody titer, antitetanus toxoid antibodies, and avidity of antibodies to tetanus. Of the infants randomized into the 4 arms of the study, 767 (71%) completed follow-up at 6 mo of age. Follow-up rates were similar in all 4 arms (69-72%, P = 0.8). Antibody titers were relatively high in all 4 groups at both 6 wk and 6 mo of age, with no differences among the groups. We found no evidence that vitamin A supplementation affects infants' antibody responses to tetanus toxoid or oral polio vaccine delivered at EPI contacts