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Advances in medical statistics arising from the AIDS epidemic.

Many statisticians have contributed to studies of the HIV epidemic and progression to AIDS. They have developed new statistical methodology, where needed, to address HIV-related issues. The transfer of methods from one area to another often involves a substantial delay. This paper points to methods that were developed in the HIV context and have either already found applications in other areas of medical research or have the potential for such applications, with the hope that this will promote a speedier transfer of the research methods. Among the new tools that HIV studies have placed firmly into the pool of statistical methods for medical research are the methods of back-calculation, methods for the analysis of retrospective ascertainment data and methods of analysis for the combined data from clinical trials and associated longitudinal studies. Notions that have been stimulated substantially are use of surrogate endpoints in clinical trials and screening blood products by the use of pooled serum samples. Research activity in many other areas has been boosted substantially through contributions motivated by HIV/AIDS studies. Noteworthy examples are analyses for doubly-censored lifetime data and methods for assessing vaccines for transmissible diseases.

AIDS Vaccines↗

Toward evidence-based medical statistics. 1: The P value fallacy.

An important problem exists in the interpretation of modern medical research data: Biological understanding and previous research play little formal role in the interpretation of quantitative results. This phenomenon is manifest in the discussion sections of research articles and ultimately can affect the reliability of conclusions. The standard statistical approach has created this situation by promoting the illusion that conclusions can be produced with certain "error rates," without consideration of information from outside the experiment. This statistical approach, the key components of which are P values and hypothesis tests, is widely perceived as a mathematically coherent approach to inference. There is little appreciation in the medical community that the methodology is an amalgam of incompatible elements, whose utility for scientific inference has been the subject of intense debate among statisticians for almost 70 years. This article introduces some of the key elements of that debate and traces the appeal and adverse impact of this methodology to the P value fallacy, the mistaken idea that a single number can capture both the long-run outcomes of an experiment and the evidential meaning of a single result. This argument is made as a prelude to the suggestion that another measure of evidence should be used--the Bayes factor, which properly separates issues of long-run behavior from evidential strength and allows the integration of background knowledge with statistical findings.

Bayes Theorem↗

Design of clinical database management systems and associated software to facilitate medical statistical research.

Clinical databases are growing rapidly. The clinical database is heavily used for medical research in many settings. This paper discusses design features for medical databases that facilitate their use for research. The database management system should allow complex data structures, have a syntax-facilitating collection of longitudinal data, interface with major statistical software packages, allow an extensive data dictionary, conveniently merge files, facilitate archival documentation, have an associated data entry system that allows complex logical checking, and have coordinated mainframe and microcomputer software.

Biometry↗

[Case histories and "medical statistics" 200 years ago--case notes by Jung-Stilling on his cataract operations 1773-1778].

At the time of Goethe, Jung-Stilling (1740-1817) was highly regarded for his cataract operations. He had a general practice in Elberfeld from 1772 to 1778 and began to carry out his eye operations there. Unpublished, handwritten notes on 92 cataract operations were found only a short time ago in the library of the University of Basle. These notes show us that Jung-Stilling wrote proper case histories that correspond somewhat to the style we use today. Apparently these notes, Report on my cataract cures and healing methods of other eye diseases, formed the basis for the statistical result he published in Marburg in 1791 that represent his main medical work: Methods of taking out cataracts and of healing...

Cataract Extraction↗

[Bayesian thinking on its way into medical statistics?].

BACKGROUND: Bayesian statistical analysis is a paradigm quite different from traditional statistical inference. We wanted to show the usefulness of this approach for some medical problems. MATERIALS AND METHODS: We started with Bayes equation as it is used for estimating the probability of illness based on a specific laboratory test. We also looked into a recent Cochrane report on mammography that accepted two studies as valid and five others as biased. In comparison we used examples of clinical trials from other areas that have been misinterpreted by the use of a traditional statistical approach only. RESULTS: We found that by taking into account our prior beliefs about the likely effects on breast cancer mortality of routine radiological screening programmes, the new data fit well into an estimate of a 5% mortality reduction with a 77% chance that there is a positive effect of screening. INTERPRETATION: Bayesian statistics is helpful in making decisions on the basis of experimental evidence by taking into account our prior knowledge, whereas p-values in traditional statistics only give information on how often we will end up with a false positive conclusion in the long run.

Bayes Theorem↗

The health of the American slave examined by means of Union Army medical statistics.

The health status of the American slave in the 19th century remains unclear despite extensive historical research. Better knowledge of slave health would provide a clearer picture of the life of the slave, a better understanding of the 19th-century medicine, and possibly even clues to the health problems of modern blacks. This article hopes to contribute to the literature by examining another source of data. Slaves entering the Union Army joined an organization with standardized medical care that generated extensive statistical information. Review of these statistics answers questions about the health of young male blacks at the time American slavery ended.

Black or African American↗