Clinical Research Papers:
A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement
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Lei Yang1,*, Shouming Chen2,*, Di Yang3, Jiajin Li4, Taixiang Wu5 and Yunxia Zuo6
1Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China
2Department of Anaesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
3Department of Anaesthesiology, Sichuan Provincial People’s Hospital, Chengdu, China
4Medical Insurance Office, West China Hospital, Sichuan University, Chengdu, China
5Chinese Clinical Trials Registry, Chengdu, China
6Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China
*These authors have contributed equally to this work
Yunxia Zuo, email: email@example.com
Keywords: clinical study; protocol; anaesthesia; SPIRIT; quality analysis
Abbreviations: SPIRIT: Standard Protocol Items: Recommendations for Intervention Trials; WHO ICTRP: World Health Organization International Clinical Trials Registry Platform; ChiCTR: Chinese Clinical Trials Registry; N/A: Not applicable
Received: January 03, 2018 Accepted: February 27, 2018 Published: May 15, 2018
Objective: To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality.
Methods: We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item).
Results: Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate.
Conclusions: The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.
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