International guidance on the selection of patient-reported outcome measures in clinical trials: a review.

PURPOSE: Patient-reported outcomes (PROs) are increasingly used in clinical trials to provide patients' perspectives regarding symptoms, health-related quality of life, and satisfaction with treatments. A range of guidance documents exist for the selection of patient-reported outcome measures (PROMs) in clinical trials, and it is unclear to what extent these documents present consistent recommendations. METHODS: We conducted a targeted review of publications and regulatory guidance documents that advise on the selection of PROMs for use in clinical trials. A total of seven guidance documents from the US Food and Drug Administration, European Medicines Agency, and scientific consortia from professional societies were included in the final review. Guidance documents were analyzed using a content analysis approach comparing them with minimum standards recommended by the International Society for Quality of Life Research. RESULTS: Overall there was substantial agreement between guidance regarding the appropriate considerations for PROM selection within a clinical trial. Variations among the guidance primarily related to differences in their format and differences in the perspectives and mandates of their respective organizations. Whereas scientific consortia tended to produce checklist or rating-type guidance, regulatory groups tended to use more narrative-based approaches sometimes supplemented with lists of criteria. CONCLUSION: The consistency in recommendations suggests an emerging consensus in the field and supports use of any of the major guidance documents available to guide PROM selection for clinical trials without concern of conflicting recommendations. This work represents an important first step in the international PROTEUS Consortium's ongoing efforts to optimize the use of PROs in clinical trials.

AHRQ series on complex intervention systematic reviews-paper 7: PRISMA-CI elaboration and explanation.

BACKGROUND: Complex interventions are widely used in health care, public health, education, criminology, social work, business, and welfare. They have increasingly become the subject of systematic reviews and are challenging to effectively report. The Complex Interventions Methods Workgroup developed an extension to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Complex Interventions (PRISMA-CI). RATIONALE: Following the EQUATOR Network guidance for Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions, this Explanation and Elaboration (EE) document accompanies the PRISMA-CI checklist to promote consistency in reporting of systematic reviews of complex interventions. DISCUSSIONS: The EE document explains the meaning and rationale for each unique PRISMA-CI checklist item and provides examples to assist systematic review authors in operationalizing PRISMA-CI guidance. The Complex Interventions Workgroup developed PRISMA-CI as an important start toward increased consistency in reporting of systematic reviews of complex interventions. Because the field is rapidly expanding, the Complex Interventions Methods Workgroup plans to re-evaluate periodically for the need to add increasing specificity and examples as the field matures.

AHRQ series on complex intervention systematic reviews-paper 6: PRISMA-CI extension statement and checklist.

BACKGROUND: Complex interventions are widely used in health systems, public health, education, and communities and are increasingly the subject of systematic reviews. Oversimplification and inconsistencies in reporting about complex interventions can limit the usability of review findings. RATIONALE: Although guidance exists to ensure that reports of individual studies and systematic reviews adhere to accepted scientific standards, their design-specific focus leaves important reporting gaps relative to complex interventions in health care. This paper provides a stand-alone extension to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting tool for complex interventions-PRISMA-CI-to help authors, publishers, and readers understand and apply to systematic reviews of complex interventions. DISCUSSION: PRISMA-CI development followed the Enhancing the QUAlity and Transparency Of health Research Network guidance for extensions and focused on adding or modifying only essential items that are truly unique to complex interventions and are not covered by broader interpretation of current PRISMA guidance. PRISMA-CI provides an important structure and guidance for systematic reviews and meta-analyses for the highly prevalent and dynamic field of complex interventions.