. 2022 May 24;12(5):e053417.

doi: 10.1136/bmjopen-2021-053417.

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

Dmitry Gryaznov¹, Belinda von Niederhäusern^{2

3}, Benjamin Speich^{1

4}, Benjamin Kasenda^{1

5}, Elena Ojeda-Ruiz^{1

6}, Anette Blümle^{7

8

9}, Stefan Schandelmaier^{1

10}, Dominik Mertz^{10

11}, Ayodele Odutayo⁴, Yuki Tomonaga¹², Alain Amstutz^{1

13}, Christiane Pauli-Magnus², Viktoria Gloy¹, Szimonetta Lohner¹⁴, Karin Bischoff^{8

9}, Katharina Wollmann^{8

9}, Laura Rehner^{9

15}, Joerg J Meerpohl^{8

9}, Alain Nordmann¹, Katharina Klatte², Nilabh Ghosh¹⁶, Ala Taji Heravi¹, Jacqueline Wong¹⁰, Ngai Chow^{10

17}, Patrick Hong^{10

18}, Kimberly A McCord-De Iaco¹, Sirintip Sricharoenchai¹, Jason W Busse^{10

19}, Arnav Agarwal¹⁰, Ramon Saccilotto¹, Matthias Schwenkglenks^{12

20}, Giusi Moffa^{1

21}, Lars Hemkens^{1

22

23}, Sally Hopewell⁴, Erik Von Elm²⁴, Matthias Briel^{25

10}

Affiliations

¹ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
² Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
³ Roche Pharma AG, Grenzach-Wyhlen, Germany.
⁴ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁵ Department of Medical Oncology, University Hospital Basel and University of Basel, Basel, Switzerland.
⁶ Preventive Medicine Department, Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Alava, Spain.
⁷ Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
⁸ Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.
⁹ Institute for Evidence in Medicine, Medical Center, University of Freiburg, Freiburg, Germany.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
¹¹ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
¹² Epidemiology, Biostatistic und Prevention Institute, University of Zurich, Zurich, Switzerland.
¹³ Clinical Research Unit, Schweizerisches Tropen- und Public Health-Institut, Basel, Switzerland.
¹⁴ Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary.
¹⁵ Institute for Nursing Science and Interprofessional Learning, University Medicine Greifswald, Greifswald, Germany.
¹⁶ Department of Neurosurgery, University of Basel, Basel, Switzerland.
¹⁷ Centre for Disability Prevention and Rehabilitation, Canadian Memorial Chiropractic College, Toronto, Ontario, Canada.
¹⁸ University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada.
¹⁹ Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
²⁰ Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
²¹ Department of Mathematics and Computer Science, University of Basel, Basel, Switzerland.
²² Meta-Research Innovation Center Berlin (METRICS-B), Berlin Institute of Health, Berlin, Germany.
²³ Meta-Research Innovation Center Stanford (METRICS), Stanford University, Stanford, California, USA.
²⁴ Cochrane Switzerland, Centre for Primary Care and Public Health (unisanté), University of Lausanne, Lausanne, Switzerland.
²⁵ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland Matthias.Briel@usb.ch.

PMID: 35613804
PMCID: PMC9125701
DOI: 10.1136/bmjopen-2021-053417

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

Dmitry Gryaznov et al. BMJ Open. 2022.

. 2022 May 24;12(5):e053417.

doi: 10.1136/bmjopen-2021-053417.

Authors

Affiliations

¹ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
² Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
³ Roche Pharma AG, Grenzach-Wyhlen, Germany.
⁴ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁵ Department of Medical Oncology, University Hospital Basel and University of Basel, Basel, Switzerland.
⁶ Preventive Medicine Department, Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Alava, Spain.
⁷ Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
⁸ Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.
⁹ Institute for Evidence in Medicine, Medical Center, University of Freiburg, Freiburg, Germany.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
¹¹ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
¹² Epidemiology, Biostatistic und Prevention Institute, University of Zurich, Zurich, Switzerland.
¹³ Clinical Research Unit, Schweizerisches Tropen- und Public Health-Institut, Basel, Switzerland.
¹⁴ Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary.
¹⁵ Institute for Nursing Science and Interprofessional Learning, University Medicine Greifswald, Greifswald, Germany.
¹⁶ Department of Neurosurgery, University of Basel, Basel, Switzerland.
¹⁷ Centre for Disability Prevention and Rehabilitation, Canadian Memorial Chiropractic College, Toronto, Ontario, Canada.
¹⁸ University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada.
¹⁹ Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
²⁰ Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
²¹ Department of Mathematics and Computer Science, University of Basel, Basel, Switzerland.
²² Meta-Research Innovation Center Berlin (METRICS-B), Berlin Institute of Health, Berlin, Germany.
²³ Meta-Research Innovation Center Stanford (METRICS), Stanford University, Stanford, California, USA.
²⁴ Cochrane Switzerland, Centre for Primary Care and Public Health (unisanté), University of Lausanne, Lausanne, Switzerland.
²⁵ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland Matthias.Briel@usb.ch.

PMID: 35613804
PMCID: PMC9125701
DOI: 10.1136/bmjopen-2021-053417

Abstract

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 reported RESULTS: 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.

Keywords: Clinical trials; EPIDEMIOLOGY; Protocols & guidelines.

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Conflict of interest statement

Competing interests: BvN is currently employed by Roche Pharma AG, Grenzach-Wyhlen, Germany. BK is currently employed by iOMEDICO AG, Freiburg, Germany. All other authors declare no financial relationships with any organisation that might have an interest in the submitted work and no other relationships or activities that could appear to have influenced the submitted work.

Figures

**Figure 1**
Proportion of reported Standard Protocol Items: Recommendations for Interventional Trials items by year and trial sponsorship.

**Figure 2**
Association between comprehensiveness of trial protocols and trial characteristics, accessed by multivariable beta regression. *Interaction terms were added to the multivariable model one at a time. CRO, contract research organisation; CTU, clinical trials unit.

See this image and copyright information in PMC

References

1. World Medical Association . WMA Declaration of Helsinki - ethical principles for medical research involving human subjects, 2013. Available: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-pr... - PubMed
1. Dwan K, Altman DG, Cresswell L, et al. . Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev 2011;1:MR000031. 10.1002/14651858.MR000031.pub2 - DOI - PMC - PubMed
1. Tetzlaff JM, Chan A-W, Kitchen J, et al. . Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev 2012;1:43. 10.1186/2046-4053-1-43 - DOI - PMC - PubMed
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Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

Affiliations

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources