Study protocols on randomized clinical trials of acupuncture: An assessment of reporting quality with the SPIRIT statement

Abstract

IntroductionThe SPIRIT Statement was published to improve the completeness and transparency of clinical trial protocols. However, a number of protocols have failed to meet these significant standards. How well acupuncture trial protocols adhere to standards, and what items are usually lacking remain unanswered. This study is to assess the reporting quality of study protocols regarding randomized clinical trials of acupuncture using the SPIRIT Statement. MethodsA literature search on acupuncture trial protocols was conducted using the following databases: PubMed, EMBASE, SCI Expanded, The Cochrane library, and four Chinese Databases. We extracted data and inputted them into pre-prepared Excel forms. We assessed the reporting quality of these acupuncture trial protocols as compared against the SPIRIT checklists, and made a comparison before and after its release. ResultsWe included 142 appropriate protocols, but none reported complete information. In general, the items that were often ignored in acupuncture protocols are the following: Protocol version, Roles and responsibilities, Interventions, Blinding, Data management, Statistical analysis, Data monitoring, Auditing, Protocol amendments, Consent or assent, Confidentiality, Access to data, Ancillary and post-trial care, Dissemination policy, and Appendices. There was no statistical difference before and after the release of SPIRIT, but except for five items in the aspects of; trial registration, study setting, participant timeline, and allocation concealment. ConclusionsStudy protocols of randomized clinical trials on acupuncture have not provided information as thoroughly as recommended in the SPIRIT Statement. Our study emphasizes the importance of comprehensive standards for trial protocols in the drafting of high-quality protocols for acupuncture.