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Summary

New SPIRIT-PRO Extension guidelines improve clinical trial protocols for patient-reported outcomes (PROs). These recommendations enhance data quality for patient-centered care and decision-making.

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Area of Science:

  • Clinical Trials Methodology
  • Patient-Reported Outcomes Research
  • Health Research Guidelines

Background:

  • Patient-reported outcome (PRO) data are crucial for shared decision-making, labeling, guidelines, and policy.
  • Current clinical trial protocols often have suboptimal PRO content.
  • The existing SPIRIT statement lacks PRO-specific guidance.

Purpose of the Study:

  • To develop international, consensus-based, PRO-specific protocol guidance, known as the SPIRIT-PRO Extension.
  • To enhance the completeness and quality of PRO data in clinical trial protocols.

Main Methods:

  • Development followed the EQUATOR Network's guideline framework.
  • Included a systematic review, stakeholder survey, Delphi exercise, and consensus meeting.
  • Utilized input from diverse international stakeholders including researchers, patients, and policymakers.

Main Results:

  • Identified 162 PRO-specific recommendations, refined to 56 items.
  • Developed 11 extensions and 5 elaborations to the SPIRIT 2013 checklist.
  • Recommendations cover PRO rationale, objectives, eligibility, assessment, instrument selection, data collection, translation, proxy completion, missing data, and monitoring.

Conclusions:

  • The SPIRIT-PRO guidelines offer essential recommendations for clinical trial protocols involving PROs.
  • Implementing these guidelines can improve the design of trials and ensure high-quality, patient-centered data.
  • This enhances the utility of PRO data for informing clinical care and health policy.