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.

How common is comorbidity and why does it occur?

Comorbidity is most generally defined as the co-occurrence of two or more mental health problems. Comorbidity between drug and other psychological disorders has emerged as a major clinical, public health and research issue over the past few decades. The reasons for comorbidity are complex. Furthermore, comorbidity is often associated with poor treatment outcome, severe illness course, and high service utilisation. This presents a significant challenge with respect to the identification, prevention and management of people with comorbid disorders. The unmet need for treatment within this group is considerable and the lack of research is unacceptable. This paper will give a brief overview of epidemiological research into comorbidity; and examine the reasons why comorbidity might occur.

Regression to the mean: what it is and how to deal with it

Background Regression to the mean (RTM) is a statistical phenomenon that can make natural variation in repeated data look like real change. It happens when unusually large or small measurements tend to be followed by measurements that are closer to the mean. Methods We give some examples of the phenomenon, and discuss methods to overcome it at the design and analysis stages of a study. Results The effect of RTM in a sample becomes more noticeable with increasing measurement error and when follow-up measurements are only examined on a sub-sample selected using a baseline value. Conclusions RTM is a ubiquitous phenomenon in repeated data and should always be considered as a possible cause of an observed change. Its effect can be alleviated through better study design and use of suitable statistical methods.

Epidemiological analysis of electroconvulsive therapy in Victoria, Australia

Objective: To determine the population-based utilization rate of electroconvulsive therapy (ECT) in Victoria between 1998-1999, to examine the characteristics of the ECT treated group, and to identify patient factors independently associated with differential rates of ECT treatment. Method: Electroconvulsive therapy is reported under statute in Victoria, Australia. Crude, age-adjusted and age-sex specific utilization rates were calculated using this statutory data for the 1998-1999 financial year and estimated mid-year populations from the Australian Bureau of Statistics. Descriptive characteristics of those treated with ECT were derived from the statutory data. Patient factors associated with an increased likelihood of ECT in the public sector were explored with logistic regression analysis, using non-ECT treated mental health patients from the Victorian Psychiatric Case Register as the reference population. Results: The crude treated-person and age-adjusted rates for the State (both public and private sectors) were 39.9 and 44.0 persons per 100 000 resident population per annum, respectively. The crude and age-adjusted administration rates were 330.3 and 362.6 ECT administrations per 100 000 resident population per annum, respectively. Age-sex specific rates varied by age and sex, with rates generally increasing with age and female sex. Overall, 62.8% of the treated group were women, 32.9% aged over 64, and 75.2% had depression. Diagnosis, age and sex each independently predicted ECT in the public sector, with diagnosis the most important factor, followed by age then sex. Conclusions: Despite decades of use, the appropriate rate of ECT utilization is still unclear. Further research should be directed at exploring the factors, including provider variables, determining ECT treatment.

The rising tide of ocean diseases: Unsolved problems and research priorities

New studies have detected a rising number of reports of diseases in marine organisms such as corals, molluscs, turtles, mammals, and echinoderms over the past three decades. Despite the increasing disease load, microbiological, molecular, and theoretical tools for managing disease in the world's oceans are underdeveloped. Review of the new developments in the study of these diseases identifies five major unsolved problems and priorities for future research: (1) detecting origins and reservoirs for marine diseases and tracing the flow of some new pathogens from land to sea; (2) documenting the longevity and host range of infectious stages; (3) evaluating the effect of greater taxonomic diversity of marine relative to terrestrial hosts and pathogens; (4) pinpointing the facilitating role of anthropogenic agents as incubators and conveyors of marine pathogens; (5) adapting epidemiological models to analysis of marine disease.

The properties of the International Classification of the External Cause of Injury when used as an instrument for injury prevention research

Objective: To demonstrate properties of the International Classification of the External Cause of Injury (ICECI) as a tool for use in injury prevention research. Methods: The Childhood Injury Prevention Study (CHIPS) is a prospective longitudinal follow up study of a cohort of 871 children 5 - 12 years of age, with a nested case crossover component. The ICECI is the latest tool in the International Classification of Diseases (ICD) family and has been designed to improve the precision of coding injury events. The details of all injury events recorded in the study, as well as all measured injury related exposures, were coded using the ICECI. This paper reports a substudy on the utility and practicability of using the ICECI in the CHIPS to record exposures. Interrater reliability was quantified for a sample of injured participants using the Kappa statistic to measure concordance between codes independently coded by two research staff. Results: There were 767 diaries collected at baseline and event details from 563 injuries and exposure details from injury crossover periods. There were no event, location, or activity details which could not be coded using the ICECI. Kappa statistics for concordance between raters within each of the dimensions ranged from 0.31 to 0.93 for the injury events and 0.94 and 0.97 for activity and location in the control periods. Discussion: This study represents the first detailed account of the properties of the ICECI revealed by its use in a primary analytic epidemiological study of injury prevention. The results of this study provide considerable support for the ICECI and its further use.