A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement

Abstract

// Lei Yang 1, * , Shouming Chen 2, * , Di Yang 3 , Jiajin Li 4 , Taixiang Wu 5 and Yunxia Zuo 6 1 Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China 2 Department of Anaesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China 3 Department of Anaesthesiology, Sichuan Provincial People’s Hospital, Chengdu, China 4 Medical Insurance Office, West China Hospital, Sichuan University, Chengdu, China 5 Chinese Clinical Trials Registry, Chengdu, China 6 Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China * These authors have contributed equally to this work Correspondence to: Yunxia Zuo, email: zuoyunxiahxa@qq.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 ABSTRACT 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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