Journal of clinical epidemiology
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Multicenter Study
Members of research ethics committees accepted a modification of the randomized consent design.
The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what extent a randomized consent design and a modification of this design is accepted by research ethics committees, in terms of ethics, health law, and methodology. ⋯ the modified randomized consent design appears to be more acceptable than the randomized consent design. To increase consistency in the way research ethics committees handle study protocols, a discussion about the use of randomized consent designs appears necessary.
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Whereas pain is frequently measured using a visual analog scale (VAS) that can examine change over short time intervals in the same subject, such ratings are not useful in analyzing differences across subjects. We created a method for normalizing VAS pain reporting to control for the variation between different populations due to the differences in subjective perception or objective evaluation of pain. ⋯ It is possible to standardize VAS pain ratings to compare pain between different populations.