Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)
Matthias Briel,
Sally Hopewell,
Arnav Agarwal,
Joerg J Meerpohl,
Jason W Busse,
Patrick Hong,
Matthias Schwenkglenks,
Szimonetta Lohner,
Benjamin Speich,
Viktoria Gloy,
Erik von Elm,
Sirintip Sricharoenchai,
Benjamin Kasenda,
Stefan Schandelmaier,
Dominik Mertz,
Anette Blümle,
Jacqueline Wong,
Alain Amstutz,
Belinda Von Niederhäusern,
Alain Nordmann,
Giusi Moffa,
Dmitry Gryaznov,
Elena Ojeda-Ruiz,
Ayodele Odutayo,
Yuki Tomonaga,
Christiane Pauli-Magnus,
Karin Bischoff,
Katharina Wollmann,
Laura Rehner,
Katharina Klatte,
Nilabh Ghosh,
Ala Taji Heravi,
Ngai Chow,
Kimberly A McCord - De Iaco,
Ramon Saccilotto,
Lars Hemkens
Affiliations
Matthias Briel
assistant professor
Sally Hopewell
professor of clinical trials and evidence synthesis
Arnav Agarwal
internist, methods co-chair
Joerg J Meerpohl
Institute for Evidence in Medicine, Medical Center – Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany
Jason W Busse
assistant professor
Patrick Hong
10 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
Matthias Schwenkglenks
associate professor
Szimonetta Lohner
14 Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary
Benjamin Speich
1 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
Viktoria Gloy
researcher
Erik von Elm
senior researcher
Sirintip Sricharoenchai
1 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
Benjamin Kasenda
researcher
Stefan Schandelmaier
researcher
Dominik Mertz
assistant professor
Anette Blümle
researcher
Jacqueline Wong
Division of Infectious Diseases, McMaster Children`s Hospital, Hamilton, Ontario, Canada
Alain Amstutz
postdoctoral researcher
Belinda Von Niederhäusern
2 Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland
Alain Nordmann
associate professor
Giusi Moffa
8 Department of Mathematics and Computer Science, University of Basel, Basel, Switzerland
Dmitry Gryaznov
1 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
Elena Ojeda-Ruiz
1 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
Ayodele Odutayo
DPhil student
Yuki Tomonaga
researcher
Christiane Pauli-Magnus
2 Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland
9 Institute for Evidence in Medicine, Medical Center, University of Freiburg, Freiburg, Germany
Katharina Klatte
2 Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland
Nilabh Ghosh
16 Department of Neurosurgery, University of Basel, Basel, Switzerland
Ala Taji Heravi
1 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
Ngai Chow
10 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
Kimberly A McCord - De Iaco
1 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
Ramon Saccilotto
researcher
Lars Hemkens
Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, Basel, Switzerland
Objectives Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist.Design Repeated cross sectional study.Setting Swiss, German and Canadian research ethics committees (RECs).Participants RCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292).Primary and secondary outcome measures The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reportedResults The median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%–79%) in 2012 to 77% (IQR, 68%–82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%–72%) in 2012 to 76% (IQR, 64%–83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%–80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship.Conclusions In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve.
