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Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects

Authors: Dmitry Gryaznov, Ayodele Odutayo, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Karin Bischoff, Katharina Wollmann, Laura Rehner, Szimonetta Lohner, Joerg J. Meerpohl, Alain Nordmann, Katharina Klatte, Nilabh Ghosh, Ala Taji Heravi, Jacqueline Wong, Ngai Chow, Patrick Jiho Hong, Kimberly Mc Cord, Sirintip Sricharoenchai, Jason W. Busse, Arnav Agarwal, Ramon Saccilotto, Matthias Schwenkglenks, Giusi Moffa, Lars G. Hemkens, Sally Hopewell, Erik von Elm, Matthias Briel

Published in: Trials | Issue 1/2020

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Abstract

Background

Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain.

Objectives and methods

Aims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries.
We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results.
We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup analyses; and the use of routinely collected data for RCTs.

Discussion

The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time.
Appendix
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Metadata
Title
Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects
Authors
Dmitry Gryaznov
Ayodele Odutayo
Belinda von Niederhäusern
Benjamin Speich
Benjamin Kasenda
Elena Ojeda-Ruiz
Anette Blümle
Stefan Schandelmaier
Dominik Mertz
Yuki Tomonaga
Alain Amstutz
Christiane Pauli-Magnus
Viktoria Gloy
Karin Bischoff
Katharina Wollmann
Laura Rehner
Szimonetta Lohner
Joerg J. Meerpohl
Alain Nordmann
Katharina Klatte
Nilabh Ghosh
Ala Taji Heravi
Jacqueline Wong
Ngai Chow
Patrick Jiho Hong
Kimberly Mc Cord
Sirintip Sricharoenchai
Jason W. Busse
Arnav Agarwal
Ramon Saccilotto
Matthias Schwenkglenks
Giusi Moffa
Lars G. Hemkens
Sally Hopewell
Erik von Elm
Matthias Briel
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04808-y

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