Development and validation of an anaesthetic consent form

Abstract

Background: Informed consent is an integral part of daily anaesthetic practice. It is an important clinical entity as well as a medico-legal obligation to inform patients of the risks of anaesthesia. The aim of this study was to develop and validate an anaesthetic consent form for surgery at the University of Witwatersrand affiliated hospitals. Methods and results: A prospective, exploratory and instrumental design was used for the study. Purposive sampling was used in Lynn’s two-stage Model of determination and quantification of content validity. The first stage, the Development Stage, involved an extensive review of the literature, which was followed by a peer group discussion. Local experts debated each item until 100% consensus was reached. The revised anaesthetic consent form consisted of 95 items. The Judgement/Quantification Stage involved 10 national experts using a four-point Likert scale for rating and validation. Items that were rated 3 or 4 were considered content valid. This resulted in 65 of 95 items being considered content valid. The revised anaesthetic consent form received a content validity index (CVI) of 0.68. Lynn suggests that for an instrument to be considered content valid, a minimum CVI of 0.8 should be obtained. Conclusion: The CVI of the final instrument did not meet content validity requirements. However, the principle of informed consent remains important in good anaesthesia practice as it is an ethical and legal requirement to obtain before any procedure. Further research is required to develop the optimal anaesthesia consent form