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

• Published in: PloS one 2013-04, Vol.8 (4), p.e60684-e60684
• Main Authors: Kyte, Derek G, Draper, Heather, Ives, Jonathan, Liles, Clive, Gheorghe, Adrian, Calvert, Melanie
• Format: Article
• Language: English
• Subjects: Analysis; Bias; Clinical outcomes; Clinical trials; Clinical Trials as Topic; Content analysis; Data analysis; Data collection; Data Collection - standards; Data Collection - utilization; Data processing; Databases, Bibliographic; Diagnostic Self Evaluation; Ethics; Guidelines; Humans; Identification methods; Management; Medical research; Medicine; Outcome and process assessment (Health Care); Outcome Assessment (Health Care) - standards; Outcome Assessment (Health Care) - utilization; Practice guidelines (Medicine); Practice Guidelines as Topic; Qualitative analysis; Quality assessment; Quality control; Recruitment; Reproducibility of Results; Research Design; Studies; Well being
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0060684

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. Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97), and validity (