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Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial.

ABSTRACT: OBJECTIVES:To assess the intention of using a Writing Aid software, which integrates four research reporting guidelines (Consolidated Standards of Reporting Trials, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Strengthening the Reporting of Observational Studies in Epidemiology and STrengthening the Reporting of Observational Studies in Epidemiology-nutritional epidemiology) and their Elaboration & Explanation (E&E) documents during the write-up of research in Microsoft Word compared with current practices. DESIGN:Two-arms crossover randomised controlled trial with no blinding and no washout period. SETTING:Face-to-face or online sessions. PARTICIPANTS:54 (28 in arm 1 and 26 in arm 2) doctoral and postdoctoral researchers. INTERVENTIONS:Reporting guidelines and their E&E document were randomly administered as Writing Aid or as Word documents in a single 30?min to 1?hour session, with a short break before crossing over to the other study intervention. PRIMARY AND SECONDARY OUTCOMES:Using the Technology Acceptance Model, we assessed the primary outcome: the difference in the mean of intention of use; and secondary outcomes: the difference in mean perceived ease of use and perceived usefulness. The three outcomes were measured using questions with a 7-point Likert-scale. Secondary analysis using structural equation modelling (SEM) was applied to explore the relationships between the outcomes. RESULTS:No significant difference in reported intention of use (mean difference and 95%?CI 0.25 (-0.05 to 0.55), p=0.10), and perceived usefulness (mean difference and 95%?CI 0.19 (-0.04 to 0.41), p=0.10). The Writing Aid performed significantly better than the word document on researchers' perceived ease of use (mean difference and 95%?CI 0.59 (0.29 to 0.89), p<0.001). In the SEM analysis, participants' intention of using the tools was indirectly affected by perceived ease of use (beta 0.53 p=0.002). CONCLUSIONS:Despite no significant difference in the intention of use between the tools, administering reporting guidelines as Writing Aid is perceived as easier to use, offering a possibility to further explore its applicability to enhance reporting adherence.

SUBMITTER: Hawwash D

PROVIDER: S-EPMC6858139 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial.

Hawwash Dana D Sharp Melissa K MK Argaw Alemayehu A Kolsteren Patrick P Lachat Carl C

BMJ open 20191106 11

<h4>Objectives</h4>To assess the intention of using a Writing Aid software, which integrates four research reporting guidelines (Consolidated Standards of Reporting Trials, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Strengthening the Reporting of Observational Studies in Epidemiology and STrengthening the Reporting of Observational Studies in Epidemiology-nutritional epidemiology) and their Elaboration & Explanation (E&E) documents during the write-up of research in Micr ...[more]

PMID: 31699728

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Project description:BackgroundRandomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias.MethodsNational and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias.ResultsSeventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported.ConclusionOur review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias. Current guidelines need to be updated and include the statement that all primary and secondary outcomes prespecified in the protocol should be fully reported and should not be selected for inclusion in the final report based on their results.

Dataset Information

Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial.

Publications

Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial.

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