Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study

Abstract

ObjectivesTo determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors.DesignMethodological study.Data sourcesMEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies.Eligibility criteriaProtocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language.Main outcomePrimary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement.Results300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement.ConclusionThe overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors

“…Given the various existing documentation that has been published to improve the quality and comprehensiveness of SPIRIT reporting in trial protocols, it is surprising that compliance is not higher. Recent research on trial protocol reporting has shown a significant improvement in the overall proportion of protocol items that are addressed since the SPIRIT guidance was published; however, this increase was only by approximately 9%, and several items were found to be less commonly reported [ 10 , 11 ]. Studies that have examined interventions to improve adherence to reporting guidelines in general have found many different types of interventions for different stages of the publication process [ 22 – 24 ].…”

“…Although the checklist was published in 2013, as with many reporting checklists such as Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Consolidated Standards of Reporting Trials (CONSORT), the adherence and compliance among publications have seen only moderate improvement. A recent methodological study compared the overall proportion of checklist items adequately reported in RCT protocols published before and after the SPIRIT statement, respectively in 2012 and 2019 [ 10 ]. The investigators found an average of 57% of items were adequately reported in 2019 protocols, as compared with 48% in protocols from 2012 [ 10 ].…”

“…A recent methodological study compared the overall proportion of checklist items adequately reported in RCT protocols published before and after the SPIRIT statement, respectively in 2012 and 2019 [ 10 ]. The investigators found an average of 57% of items were adequately reported in 2019 protocols, as compared with 48% in protocols from 2012 [ 10 ]. While this is a mean improvement of 9%, for the 55 items in the SPIRIT checklist, the results suggest that after 6 years, not even two-thirds of all items are adequately reported, and the investigators found no protocols among the 150 from 2019 addressed all items [ 10 ].…”

“…The investigators found an average of 57% of items were adequately reported in 2019 protocols, as compared with 48% in protocols from 2012 [ 10 ]. While this is a mean improvement of 9%, for the 55 items in the SPIRIT checklist, the results suggest that after 6 years, not even two-thirds of all items are adequately reported, and the investigators found no protocols among the 150 from 2019 addressed all items [ 10 ]. Understanding the features of protocols associated with non-adherence and how reporting standards may be improved is still an area of active research interest [ 11 ].…”

Developing the RIGHT extension statement for practice guideline protocols: the RIGHT-P statement protocol

“…For example, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for protocols (PRISMA-P) was developed in 2015 to improve the reporting quality of systematic reviews and metaanalysis protocols. 12 One study 13 showed that the reporting quality of protocols of clinical trials has improved by 8.8% since the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. 14 To our knowledge, there are no widely agreed on guidelines or standards for how guideline protocols should be reported.…”