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PubMed2005

Viewpoint: pancakes and medical statistics.

Everyone is willing to expend considerable effort seeking authenticity; for example, the author sometimes travels over 100 miles to eat authentic and delicious homemade pancakes in a small-town restaurant. In the same way, physicians seek authenticity of care, which is another way of saying they seek the truest knowledge available when treating their patients. Because there are so many possible causes of many patients' complaints, physicians invoke the statistical theory behind the chief complaint (e.g., Which test for the complaint has the highest value?). In a world where medicine must be practiced with attention to resources and cost and where the answer must be reached in the fewest steps, evidence-based medicine (EBM) has risen to prominence. But how do clinicians ensure that the EBM literature is giving them the truest available knowledge? The author observes that clinicians and others have trusted the peer-review system to safeguard them against errors in the clinical literature. But he contends that errors are getting through at an increasing rate, and that physicians cannot automatically trust the peer-review process. Instead, they must become judges of experimental design, statistics, and analysis and assume the responsibilities that they had hoped the peer-review system would bear for them. He speculates about the reasons that peer review is no longer sufficiently ensuring authenticity in the literature. And to alleviate this problem, he recommends that current approaches to educating physicians about experimental design and statistics be augmented by making a beginning knowledge of statistics a requirement for entry into medical school.

Evidence-Based Medicine↗
PubMed1979

[Infusions emergencies following the administration of plasma substitutes -- analysis of case reports to the committee on drugs. The problems of medical statistics, prophylaxis and immediate therapy (author's transl)].

In the period 1967 to 1976 the Adverse Drug Reaction Committee of the Medical Association of the Federal Republic of Germany (AMK) received 323 reports of transfusion emergencies following the administration of colloid plasma expanders (dextran, gelatin, starch). The reports ranged from medium to severe cases. Nine percent of the reported cases had a fatal outcome. The data contained in these case reports could only be statistically analyzed within certain limitations as the reports were incomplete and other parameters necessary for a definite statistical evaluating were missing. Furthermore the results do not cover the following points: 1. What percentage of reactions to plasma expanders in W. Germany was reported? --2. What percentage can be attributed to the individual colloids within the entirety of these undesirable side effects? --3. What percentage of the individual colloids can be allocated to the varying degrees of severity of these reactions? -- Further limitations which complicated the analysis of the case reports are discussed individually. Despite these difficulties an attempt was made to analyse the parameters necessary in the diagnosis of acute transfusion emergencies and to compile a guide for the clinical symptomatology. Grading of reactions into four degrees of severity has proved useful both in terms of diagnosis and immediate therapy. The medical statistical evaluation presented in this paper gives an indication as to the significance of the observed side-effects and confirms the statement and recommendations made elsewhere in the literature. In these emergency cases life-threatening incidents appear to be more common than is generally assumed and the user is aware of. The incidence of product-specific emergencies can only be determined to some degree of accuracy by randomized prospective studies. These would have to be conducted with numerous strict guidelines. On the basis of the results presented here, these studies should be attended to with a sense of urgency. Regardless of the difficulties encountered in the evaluation of the case reports, guidelines as to the recognition of reactions, prophylaxis and immediate remedial therapy could be established. These would appear to suffice as urgently required comprehensive information for the nursing staff as well as all doctors. Recognizing side-effects and instituting immediate remedial therapy along the principles laid down in these guidelines can in most cases of severe reactions remove the acute threat to life.

Adolescent↗
PubMed1999

Toward evidence-based medical statistics. 2: The Bayes factor.

Bayesian inference is usually presented as a method for determining how scientific belief should be modified by data. Although Bayesian methodology has been one of the most active areas of statistical development in the past 20 years, medical researchers have been reluctant to embrace what they perceive as a subjective approach to data analysis. It is little understood that Bayesian methods have a data-based core, which can be used as a calculus of evidence. This core is the Bayes factor, which in its simplest form is also called a likelihood ratio. The minimum Bayes factor is objective and can be used in lieu of the P value as a measure of the evidential strength. Unlike P values, Bayes factors have a sound theoretical foundation and an interpretation that allows their use in both inference and decision making. Bayes factors show that P values greatly overstate the evidence against the null hypothesis. Most important, Bayes factors require the addition of background knowledge to be transformed into inferences--probabilities that a given conclusion is right or wrong. They make the distinction clear between experimental evidence and inferential conclusions while providing a framework in which to combine prior with current evidence.

Bayes Theorem↗