SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Research output: Contribution to journalArticlepeer-review


  • Madeleine King
  • Rebecca Mercieca-bebber
  • A. W. Chan
  • Ethan Basch
  • JA Bell
  • AV Bennett
  • V Bhatnagar
  • J Blazeby
  • A Bottomley
  • J. Brown
  • L Campbell
  • JC Cappelleri
  • H Draper
  • A Dueck
  • C Ells
  • L Frank
  • Robert M. Golub
  • I Griebsch
  • Kirstie Haywood
  • A Hunn
  • BL King-Kallimanis
  • L Martin
  • S Mitchell
  • T Morel
  • L Nelsen
  • Josephine M. Norquist
  • D O'Connor
  • Michael J Palmer
  • D Patrick
  • Gary Price
  • A Regnault
  • D Revicki
  • J. Scott
  • R Stephens
  • Grace Turner
  • A Valakas
  • Galina Velikova
  • Maria Von Hildebrand
  • Anita Walker
  • Linda Wenzel

Colleges, School and Institutes


Patient reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses, and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the SPIRIT-PRO Extension. The SPIRIT-PRO Extension is a sixteen-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO Explanation and Elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item’s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs. Article Summary Strengths and limitations of this study • The SPIRIT-PRO Extension aims to improve the completeness and transparency of trial protocols where patient-reported outcomes (PROs) are a primary or key secondary outcomes and was developed following EQUATOR Network Guidance. • This Explanation and Elaboration paper provides information to promote understanding and facilitate uptake of the recommended PRO protocol SPIRIT-PRO checklist items for clinical trials. • A comprehensive protocol template and selected examples from existing trial protocols are provided to facilitate implementation. • The protocol template and explanation and elaboration paper were developed with multi-stakeholder international input including: trialists, PRO methodologists, psychometricians, patient partners, industry representatives, journal editors, regulators and ethicists. • Although the guidance is limited in focus to clinical trials, many of the SPIRIT-PRO items may also provide useful prompts about PRO content for cohort studies and other non-randomised designs.


Original languageEnglish
Article numbere045105
Number of pages35
Issue number6
Publication statusPublished - 30 Jun 2021

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