Patient reported outcomes (PROs) in clinical trials : is 'in-trial' guidance lacking? a systematic review

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Colleges, School and Institutes


Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas.


Original languageEnglish
Article numbere60684
JournalPLoS ONE
Issue number4
Publication statusPublished - 1 Apr 2013