Abstract
BackgroundThe systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. One such review was carried out for the question of why post-trial access to trial drugs should or need not be provided. The objective of this study was to empirically validate this review using an author check method. The article also reports on methodological challenges faced by our study.MethodsWe emailed a questionnaire to the 64 corresponding authors of those papers that were assessed in the review of reasons on post-trial access. The questionnaire consisted of all quotations (“reason mentions”) that were identified by the review to represent a reason in a given author’s publication, together with a set of codings for the quotations. The authors were asked to rate the correctness of the codings.ResultsWe received 19 responses, from which only 13 were completed questionnaires. In total, 98 quotations and their related codes in the 13 questionnaires were checked by the addressees. For 77 quotations (79%), all codings were deemed correct, for 21 quotations (21%), some codings were deemed to need correction. Most corrections were minor and did not imply a complete misunderstanding of the citation.ConclusionsThis first attempt to validate a review of reasons leads to four crucial methodological questions relevant to the future conduct of such validation studies: 1) How can a description of a reason be deemed incorrect? 2) Do the limited findings of this author check study enable us to determine whether the core results of the analysed SRR are valid? 3) Why did the majority of surveyed authors refrain from commenting on our understanding of their reasoning? 4) How can the method for validating reviews of reasons be improved?
Highlights
The systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics
Rationale and an example of a systematic review of reasons A systematic review of reasons in philosophical bioethics [1,2,3,4,5,6] is a new way for decision-makers to obtain comprehensive information about specific ethical topics [7]
The survey tried to test this hypothesis as well as to explore the general possibility of validation of an Systematic review of reason (SRR). The method for this survey and its results are presented.b Owing to the low response rate and the inherent methodological challenges we found in the course of this first validation study of reason-codings, our discussion focuses on these issues – in regard to our study, and with a view to future validation studies of SRRs
Summary
The systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. This method is purely descriptive; nor does it review and synthesize quantitative data as reviews of clinical trials or survey research do [9,10].a The rationale for using this method is to avoid bias when summarizing reasons that are published in scientific literature, and to provide a comprehensive set of reasons for or against a course of action, especially when developing policy or guidelines, as a biased or incomplete sample of reasons may lead to ethically problematic recommendations (see [7,9]) One such SRR was performed for the question of why post-trial access (PTA) to trial-drugs should or need not be provided [4]. The results of the review, as well as the actual method used, are of no concern here (for those, see [4,11]); rather, we shall ask whether this review – and, by implication, any other SRR – can be empirically validated, i.e., whether it is possible to verify the coding done by the reviewers in order to classify different kinds of reasons given in the references
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