Unpublished studies
Appraisal of: “Korevaar DA, Hooft L, Askie LM, Barbour V, Faure H, Gatsonis CA, et al. Facilitating Prospective Registration of Diagnostic Accuracy Studies: A STARD Initiative. Clin Chem. 2017;63: 1331–1341.”
This paper provides the arguments for prospective registration of diagnostic test accuracy (DTA) studies in public databases. The authors do not advocate the creation of a specific registry for DTA studies, but registration is recommended in any available known public registry. A list of possible registries is provided in Table 1 of the paper.
The authors propose a modified version of the WHO trial registration data set (Table 2 in the paper) which specifies the fields that would be needed for registry records to capture the key elements of a DTA study.
Using their modified version of the WHO trial registration data set, the authors evaluated the reported information for the 30 most recently registered DTA studies in the WHO ICTRP in November 2016. This small analysis provides some information for searchers who are searching for DTA studies in ICTRP. In the sample of thirty studies, 90% reported that the study was a DTA study in the title of the record, 97% reported the target condition and 100% reported the index test.
The authors call on trial registries to ensure informative data are included in registry records to enhance identification. They also call on journal editors to encourage DTA study registration prior to publication.
Appraisal of: Wieseler B, Wolfram N, McGauran N et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 2013;10(10):e1001526.
Appraisal of: Golder S, Loke YK. Sources of information on adverse effects. Health Info Libr J 2010;27:176-190.
Appraisal of: Golder S, Loke YK, Bland M. Unpublished data can be of value in systematic reviews of adverse effects: methodological overview. J Clin Epidemiol 2010;63(10):1071-1081.
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