Artikel
Longitudinal evaluation of the reporting quality of clinical trial protocols – evidence for improvement? The Adherence to SPIrit REcommendations (ASPIRE) Study
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Autoren
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Dmitry Gryaznov
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
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Benjamin Kassenda
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
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Erik von Elm
- Cochrane Switzerland, Schweiz
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Belinda von Niederhäusern
- University Hospital Basel, Clinical Trial Unit, Department of Clinical Research, Basel, Schweiz
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Benjamin Speich
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
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Lars G. Hemkens
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
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Stefan Schandelmaier
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
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Elena Ojeda Ruiz
- Cochrane Switzerland, Schweiz
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Kimberly Alba Mc Cord
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
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Ramon Saccilotto
- University Hospital Basel, Department of Clinical Research, Basel, Schweiz
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Yuki Tomonaga
- University of Zurich, Epidemiology, Biostatistics and Prevention Institute (EBPI), Zurich, Schweiz
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Alain Amstutz
- University of Basel, Basel, Schweiz
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Matthias Briel
- University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Schweiz
| Veröffentlicht: | 12. Februar 2020 |
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Gliederung
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Background/research question: We investigated the reporting quality of randomized clinical trial (RCT) protocols approved by Swiss research ethics committees (RECs), before the introduction of the Human Research Act in Switzerland in 2014 and the publication of the SPIRIT guidelines in 2013, and thereafter based on the SPIRIT checklist. We determined trial characteristics associated with non-adherence to SPIRIT items.
Methods: We included all RCT protocols approved by Swiss RECs in 2012 and 2016. For each protocol, we extracted information on general trial characteristics and evaluated for each of the SPIRIT checklist items whether the respective information was reported in the RCT protocol. We calculated the adherence to SPIRIT in terms of the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items.
Results: We included 183 RCT protocols approved in 2012 and 217 in 2016. No difference was found in the median proportion of reported SPIRIT items between protocols from 2012 (median 74%, interquartile range [IQR], 64%-80%) and 2016 (median 76%, IQR, 69%-82%). Significant improvement was found for non-industry-sponsored protocols (interaction p-value <0.01); the median proportion increased from 65% (IQR, 56%-74%) in 2012 to 76% (IQR, 66%-83%) in 2016, while for industry-sponsored protocols median adherence remained on a high level (79%, IQR 75%-82% in 2012, and 77%, IQR 72%-82% in 2016). Improvement in adherence of non-industry-sponsored protocols was due to an improvement in 23 individual SPIRIT items improving by 10% or more. The following RCT characteristics were significantly and independently associated with lower adherence to SPIRIT: single centre, no support from CTU or CRO, non-industry-sponsoring, and approval in 2012.
Conclusion: Industry-sponsored RCT protocols were more complete according to SPIRIT than non-industry-sponsored protocols approved in Switzerland in 2012, but non-industry protocols showed moderate improvement when compared to 2016, while industry protocols remained on a high level.
Competing interests: The authors declare no conflict of interest
