Access to death certificates: What should research ethics committees require for approval?

PURPOSE: To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval Of a study requiring access to death certificates to identify the physicians signing the certificates and to send them a four-page questionnaire about medical decisions made at the patient's end-of-life that could possibly have hastened death. METHODS: A simple questionnaire were sent to the responsible national investigator in an international study (Australia, Belgium, Denmark, Italy, the Netherlands, Sweden, Switzerland) asking about the interactions between the national research group and the national/regional REC(s). RESULTS: Different laws or guidelines were used by the RECs. Denmark, the Netherlands, and Switzerland did not require an application to a REC. In Australia and Sweden, the RECs wanted changes in the research protocol, and one national research group had to refrain from publishing its results because the attrition rate became too high, probably due to the required changes in the protocol. RECOMMENDATIONS: Generally, similar demands from all RECs in relation to one project are strongly desirable. In epidemiological research, in which Voluntary completion of an anonymous questionnaire demonstrates consent, additional prior informed consent about being approached should not be required.

Co-existing conditions for deaths from infectious and parasitic diseases in Australia

Objective: To examine the frequency distribution of co-existing conditions for deaths where the underlying cause was infectious and parasitic diseases. Materials and methods: Besides the underlying cause of death, the distributions of co-existing conditions for deaths from infectious and parasitic diseases were examined in total and by various age and sex groups, at individual and chapter levels, using 1998 Australian mortality data. Results: In addition to the underlying cause of death, the average number of reported co-existing conditions for a single infectious and parasitic death was 1.62. The most common co-existing conditions were respiratory failure, acute renal failure non-specific causes, ischaemic heart disease, pneumonia and diabetes. When studying the distribution of co-existing conditions at the ICD-9 chapter level, it was found that the circulatory system diseases were the most important. There was an increasing trend in the number of reported co-existing conditions from 60 years of age upwards. Gender differences existed in the frequency of some reported co-existing conditions. The most common organism types of co-existing conditions were other bacterial infection and other viruses. Conclusions: The study indicated that the quality of death certificates is less than satisfactory for the 1998 Australian mortality data. The findings may be helpful in clarifying the ICD coding rules and the development of disease prevention strategies. (C) 2003 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Correcting for numerator/denominator bias when assessing changing inequalites in occupational class mortality, Australia 1981-2002

Objective Comparisons of the changing patterns of inequalities in occupational mortality provide one way to monitor the achievement of equity goals. However, previous comparisons have not corrected for numerator/denominator bias, which is a consequence of the different ways in which occupational details are recorded on death certificates and on census forms. The objective of this study was to measure the impact of this bias on mortality rates and ratios over time. Methods Using data provided by the Australian Bureau of Statistics, we examined the evidence for bias over the period 1981-2002, and used imputation methods to adjust for this bias. We compared unadjusted with imputed rates of mortality for manual/non-manual workers. Findings Unadjusted data indicate increasing inequality in the age-adjusted rates of mortality for manual/non-manual workers during 1981-2002, Imputed data suggest that there have been modest fluctuations in the ratios of mortality for manual/non-manual workers during this time, but with evidence that inequalities have increased only in recent years and are now at historic highs. Conclusion We found that imputation for missing data leads to changes in estimates of inequalities related to social class in mortality for some years but not for others. Occupational class comparisons should be imputed or otherwise adjusted for missing data on census or death certificates.