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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

Gryaznov, Dmitry and Odutayo, Ayodele and von Niederhäusern, Belinda and Speich, Benjamin and Kasenda, Benjamin and Ojeda-Ruiz, Elena and Blümle, Anette and Schandelmaier, Stefan and Mertz, Dominik and Tomonaga, Yuki and Amstutz, Alain and Pauli-Magnus, Christiane and Gloy, Viktoria and Bischoff, Karin and Wollmann, Katharina and Rehner, Laura and Lohner, Szimonetta and Meerpohl, Joerg J. and Nordmann, Alain and Klatte, Katharina and Ghosh, Nilabh and Heravi, Ala Taji and Wong, Jacqueline and Chow, Ngai and Hong, Patrick Jiho and Cord, Kimberly Mc and Sricharoenchai, Sirintip and Busse, Jason W. and Agarwal, Arnav and Saccilotto, Ramon and Schwenkglenks, Matthias and Moffa, Giusi and Hemkens, Lars G. and Hopewell, Sally and von Elm, Erik and Briel, Matthias. (2020) 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. Trials, 21 (1). p. 896.

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Official URL: https://edoc.unibas.ch/81048/

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Abstract

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.; 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.; 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.
Faculties and Departments:05 Faculty of Science > Departement Mathematik und Informatik > Mathematik > Statistik (Moffa)
UniBasel Contributors:Moffa, Giusi
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BioMed Central
ISSN:1468-6708
e-ISSN:1745-6215
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:08 Feb 2021 11:01
Deposited On:01 Feb 2021 12:22

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