A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials.

OBJECTIVE: To pilot informed consent materials developed for Aboriginal parents in a vaccine trial, and evaluate their design and the informed consent process. METHODS: Cross sectional quantitative and qualitative survey of 20 Aboriginal and 20 non-Aboriginal women in Alice Springs. Information about the proposed research was presented to Aboriginal participants by an Aboriginal researcher, using purpose designed verbal, visual, and written materials. Non-Aboriginal participants received standard materials developed by the sponsor. Questionnaires were used to evaluate recall and understanding immediately and five days later. Qualitative analysis of Aboriginal participants' interviews was performed. RESULTS: There were no differences between the groups in understanding of diseases prevented by the vaccine, the potential risks of participating, or the voluntary nature of participation. Most Aboriginal participants had difficulty with the concept of a "licensed" versus "unlicensed" vaccine. The non-Aboriginal group had a good understanding of this. Aboriginal participants identified the use of the flipchart, along with a presentation by a doctor and Aboriginal health worker, as preferred delivery modes. Group presentations were preferred rather than one-on-one discussions. The use of the questionnaire posed considerable methodological difficulties. CONCLUSIONS: A one-off oral presentation to Aboriginal participants is unlikely to produce "informed consent". Key but unfamiliar concepts require identification and particularly considered presentation.

Haemophilus influenzae type b infection in children in Pacific countries.

The Haemophilus influenzae type b (Hib) disease burden among children under five years in four Pacific island countries (PIC was estimated. The incidence of confirmed Hib meningitis was calculated using numbers of culture confirmed isolates. In addition, the WHO Hib Rapid Assessment Tool (RAT) was used to estimate the true Hib meningitis incidence and the number of Hib meningitis and pneumonia cases and deaths. The Hib meningitis annual incidence in three PICs was 70 to 84 per 100,000 children under five years. The high Hib disease burden and the relative cost-effectiveness of Hib vaccine, make the introduction of Hib vaccine a good investment for PICs costing US$ 1,000-10,000 for each death prevented - ignoring treatment cost savings.

High incidence of Haemophilus influenzae type b infection in children in Pacific island countries.

The Haemophilus influenzae type b (Hib) disease burden among children <5 years old in 4 Pacific island countries (PICs) was estimated. The incidence of confirmed Hib meningitis was calculated using the numbers of culture-confirmed isolates. In addition, the World Health Organization (WHO) Hib Rapid Assessment Tool (RAT) was used to estimate the true Hib meningitis incidence and the number of Hib meningitis and pneumonia cases, as well as the number of deaths due to Hib meningitis and pneumonia. The Hib meningitis annual incidence in 3 PICs was 70-84 cases per 100,000 children <5 years old. For PICs, the RAT is likely to overestimate the Hib pneumonia burden, as it assumes a 5 : 1 ratio of Hib pneumonia to Hib meningitis. The true ratio is likely to be 1 : 1. The high Hib disease burden and the relative cost-effectiveness of Hib vaccine make the introduction of Hib vaccine a good investment for PICs, costing US1000 dollars-US10,000 dollars for each death prevented--a number that ignores savings from reductions in the cost of treatment.