SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

By A. Chan, J. Tetzlaff, P. Gøtzsche, Douglas G. Altman, H. Mann, Jesse Berlin, K. Dickersin, A. Hrõbjartsson, K. F. Schulz, W. Parulekar and 3 more. British medical journal, 2013

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High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

Subfields: Economics and Econometrics, Public Health, Environmental and Occupational Health, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/06f7b30afd601a303a17726dab0a109d3dc394d4

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Citations in the corpus

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension (2018, methodology): “Survey participants were asked to rate the importance of including each of the 56 candidate items in the final SPIRIT-PRO Extension using a 9-point scale ranging from not important (1-3) to important but not critical (4-6) and critical (7-9).”
The COMET Handbook: version 1.0 (2017, methodology): “Existence of a common set of outcomes does not preclude inclusion of additional relevant outcomes for a given trial’ [176].”
Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014, neutral): “protocols, SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), provides some recommendations for describing interventions in protocols.(9) More generic and comprehensive guidance is needed along with robust ways to implement such guidance.”
CONSORT 2025 statement: updated guideline for reporting randomised trials (2025, neutral): “…and transparent reporting of trial protocols led to the development of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement, published in 2013, 11 and its accompanying explanation and elaboration document 12 explaining the principles underlying the statement.”
Effectiveness of positive psychology interventions: a systematic review and meta-analysis (2020, methodology): “The main implication of our results for research is that future PPI RCTs should be more methodologically rigorous and follow best practice guidelines in both execution and results reporting (Chan et al., 2013; Moher et al., 2010).”