What question did this study set out to answer?

To develop international, consensus-based, patient-reported outcome (PRO) specific protocol guidance (the SPIRIT-PRO Extension) to improve trial protocol completeness and design.

February 6, 2018JAMAOpen Access

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

View Full Paper

Ask AI

Bookmark

Authors

MCMelanie CalvertHeart Failure & Transplant DKDerek KyteUniversity of Birmingham RMRebecca Mercieca‐BebberThe University of Sydney

Discussion

Member takes

Implication

Consensus study reports standard recommendations for patient-reported outcomes in clinical trial protocols, highlighting key items to enhance trial quality and data completeness.

Key Points

To develop international, consensus-based, patient-reported outcome (PRO) specific protocol guidance (the SPIRIT-PRO Extension) to improve trial protocol completeness and design.
Followed the EQUATOR Network framework, synthesizing 162 recommendations from 54 sources into 56 items via an expert taskforce (n=21).
Conducted an international stakeholder survey (n=138) and an international Delphi consensus exercise (n=99 panelists).
Finalized guidance through a consensus meeting (n=29 voting participants) and an external expert consultation period.
Recommended 11 extensions and 5 elaborations to the SPIRIT 2013 checklist for protocols where PROs are primary or key secondary outcomes.
Addressed key PRO components including study rationale, eligibility, assessment schedule, instrument selection, proxy completion, and strategies to minimize missing data.

Cite This Study

Calvert et al. (2018) studied this question.

synapsesocial.com/papers/6a7fa2a5bf42671aa0d76f97 https://doi.org/10.1001/jama.2017.21903

View Full Paper

Ask AI

Bookmark

Implication

Consensus study reports standard recommendations for patient-reported outcomes in clinical trial protocols, highlighting key items to enhance trial quality and data completeness.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

Discussion

Member takes

Implication

Key Points

Cite This Study

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

Discussion

Member takes

Implication

Key Points

Cite This Study

Also Consider

Also Consider