Developing an evidence-based reporting guideline for randomized controlled trial protocols: The SPIRIT Initiative

Abstract

Protocols of randomized controlled trials (RCT) are important for many stakeholders including trialists, consumers, ethics boards, funding agencies and journal editors. However, RCT protocols often incompletely describe important trial details or describe inadequate methods. Biased methodological changes are also prevalent. This thesis' objective was to provide the evidence-base for the SPIRIT (Standard Protocol Items for RandomIzed T rials) Initiative, which aims to increase transparency by developing a reporting guideline for RCT protocols. Guideline content was developed and refined by: 1) a Delphi survey of key stakeholders and 2) a systematic review of empirical evidence. These two components yielded divergent yet complementary perspectives for concepts that RCT protocols should address. Cumulatively, 41 concepts related to trial methodology, administration/organization, ethics and dissemination were recommended for inclusion and 24 concepts for further discussion. These findings inform the SPIRIT guideline content and may ultimately help to improve protocol transparency and the validity of healthcare literature.