Reporting clinical trials from the viewpoint of a patient's choice of treatment.
Those who report a clinical trial should acknowledge the right of the 'consumer' to make decisions based on his own valuation of the beneficial and adverse effects which rival treatments may have. Suppose a new patient is inclined to trade one unit of benefit for c units of complication. Then he should (should not) be given the treatment if his estimated utility gain, x1-cx2, is positive (negative) and statistically significant according to the data of the trial; here x1 (x2) denotes the observed average benefit (complication level). If the estimated gain is not statistically significant, the data do not allow any firm recommendation. This c-dependent recommendation in general cannot be determined from inspection of a joint confidence region for the two means concerned. Therefore investigators should present the outcome of the significance test as a function of c (inverted inference). Typically there are several types of adverse effect or benefit, in which case the quantity c must be generalized into a vector of personal relative utility weights.
Institute of Medical Genetics (Biostatistics), University of Copenhagen, Denmark.
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D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D003662:Decision Theory; D006801:Humans; D010358:Patient Participation