International Society for Quality of Life Research
International Society for Quality of Life Research

Best Practices for PROs in Randomized Clinical Trials

Building on the success of the ISOQOL Reporting Guidelines Task Force and ISOQOL’s role in the development of the CONSORT PRO Extension, the Task Force is developing best practices documentation for patient-reported outcomes (PROs) in randomized clinical trials (RCTs). 

Protocol Checklist Development Team

Team Leaders

Melanie Calvert, PhD, University of Birmingham, United Kingdom
Madeleine King, PhD, Psycho-oncology Cooperative Research Group (PoCoG), University of Sydney, Australia

Seeking additional Team Leaders and Members from ISOQOL Membership

Team Membership

This task force team is currently seeking ISOQOL members with experience relevant to design and implementation of PRO components of RCTs.

Objectives

  • Develop and evaluate a user-friendly checklist for writing PRO components of RCT protocols
  • Develop and evaluate in-field guidance for writing standard operating procedures and other manuals for collecting RCT PRO data in the field, and to provide potential solutions/models for best practice in data collection procedures, including logistical, data quality, and ethical considerations
  • Develop and evaluate teaching modules that address current knowledge and best practices for designing PRO components of clinical trials
  • Promote the use of these teaching modules in various contexts (cooperative groups, post-graduate teaching curricula, etc)
  • Acquire external funding in support of this task force work

CONSORT PRO Guidance Implementation Tools Team

Team Leaders

Michael Brundage, MD, Queens University, Canada
Melanie Calvert, PhD, University of Birmingham, United Kingdom

Team Membership

This task force team is currently seeking ISOQOL members with relevant experience, such as use of PROs in clinical trials or experience in developing education interventions, to serve on this task force. Individuals with adult education knowledge or web-based education knowledge are strongly encouraged to participate.

Objectives

  • Develop and evaluate user-centered tools for implementing CONSORT extension guidance for PROs
  • Promote use of these tools with authors (e.g., clinical trials cooperative groups) and reviewers/editors
  • Develop and evaluate teaching modules that address current knowledge and best practices for designing PRO components of clinical trials
  • Promote the use of these teaching modules in various contexts (cooperative groups, post-graduate teaching curricula, etc)
  • Acquire external funding in support of the task force work

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Phone: +1 (414) 918-9797; Fax: +1 (414) 276-3349
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