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      Reporting of flow diagrams in randomised controlled trials published in periodontology and implantology: a survey

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          Abstract

          Background

          Item 13 of the CONSORT guidelines recommends documentation of the participant flow in randomised clinical trials (RCTs) using a diagram. In the medical literature, the reporting of the flow of participants in RCTs has been assessed to be inadequate. The quality of reporting flow diagrams in periodontology and implantology remains unknown. The aim of this study was to assess the reporting of flow diagrams in RCTs published in periodontology and implantology journals.

          Materials and Methods

          RCTs published between 15 th January 2018 and 15 th January 2022 in twelve high-ranked periodontology and implantology journals were identified. Trial characteristics at the RCT level were extracted. The flow diagram included in each RCT was assessed for completeness of reporting in relation to published criteria and the CONSORT flow diagram template.

          Results

          From the 544 eligible articles, 85% were single-centre, 82% of parallel-group design and 79% investigated surgical interventions. Three-hundred and fifteen (58%) articles were published in CONSORT endorsing journals. A flow diagram was reported in 317 (58%) trials and reporting was more common in periodontology (73.1%). Overall, 56% of publications with a flow diagram reported a complete CONSORT flow diagram, while in 44% of flow diagrams, at least one point from the CONSORT reporting template was missing. Reasons for loss to follow-up (69.7%) and exclusions from the RCT analysis (86.4%) were poorly reported.

          Conclusion

          The reporting of flow diagrams in periodontology and implantology RCTs was sub-optimal. Greater awareness of the importance of fully completing the participant CONSORT flow diagram is required.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12874-023-01923-7.

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          Most cited references27

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          CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

          Kenneth F Schulz, Douglas G. Altman, David Moher … (2010)
          The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience
          Article 0 comments Cited 1559 times – based on 0 reviews     Review now
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            Biomedical research: increasing value, reducing waste.

            Rustam Al-Shahi Salman, Paul Glasziou, An-Wen Chan … (2014)
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              Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions.

              David J. Evans (2002)
              A number of hierarchies of evidence have been developed to enable different research methods to be ranked according to the validity of their findings. However, most have focused on evaluation of the effectiveness of interventions. When the evaluation of healthcare addresses its appropriateness or feasibility, then existing hierarchies are inadequate. This paper reports the development of a hierarchy for ranking of evidence evaluating healthcare interventions. The aims of this hierarchy are twofold. Firstly, it is to provide a means by which the evidence from a range of methodologically different types of research can be graded. Secondly, it is to provide a logical framework that can be used during the development of systematic review protocols to help determine the study designs which can contribute valid evidence when the evaluation extends beyond effectiveness. The proposed hierarchy was developed based on a review of literature, investigation of existing hierarchies and examination of the strengths and limitations of different research methods. The proposed hierarchy of evidence focuses on three dimensions of the evaluation: effectiveness, appropriateness and feasibility. Research that can contribute valid evidence to each is suggested. To address the varying strengths of different research designs, four levels of evidence are proposed: excellent, good, fair and poor. The strength of the proposed hierarchy is that it acknowledges the valid contribution of evidence generated by a range of different types of research. However, hierarchies only provide a guide to the strength of the available evidence and other issues such as the quality of research also have an important influence.
              Article 0 comments Cited 124 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Clovis Mariano Faggion Jr: clovis.faggion@ukmuenster.de , clovisfaggion@yahoo.com
                Journal
                Journal ID (nlm-ta): BMC Med Res Methodol
                Journal ID (iso-abbrev): BMC Med Res Methodol
                Title: BMC Medical Research Methodology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2288
                Publication date (Electronic): 27 April 2023
                Publication date PMC-release: 27 April 2023
                Publication date Collection: 2023
                Volume: 23
                Electronic Location Identifier: 105
                Affiliations
                [1 ]GRID grid.16149.3b, ISNI 0000 0004 0551 4246, Department of Prosthodontics and Biomaterials, Faculty of Dentistry, , University Hospital Münster, ; Waldeyerstraße 30, 48149 Münster Münster, Germany
                [2 ]GRID grid.5734.5, ISNI 0000 0001 0726 5157, Department of Orthodontics and Dentofacial Orthopedics, Dental School/Medical Faculty, , University of Bern, ; Bern, Switzerland
                [3 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, Centre for Craniofacial Development & Regeneration, Faculty of Dentistry, , Oral & Craniofacial Sciences, King’s College London, ; Floor 25, Guy’s Hospital, London, SE1 9RT UK
                [4 ]GRID grid.16149.3b, ISNI 0000 0004 0551 4246, Department of Periodontology and Operative Dentistry, Faculty of Dentistry, , University Hospital Münster, ; Waldeyerstraße 30, 48149 Münster Münster, Germany
                Article
                Publisher ID: 1923
                DOI: 10.1186/s12874-023-01923-7
                PMC ID: 10134555
                SO-VID: 736d2c62-a419-495e-996f-b27db31db059
                Copyright © © The Author(s) 2023
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 19 December 2022
                Date accepted : 14 April 2023
                Funding
                Funded by: Universitätsklinikum Münster (8918)
                Open Access :

                Open Access funding enabled and organized by Projekt DEAL.

                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2023

                ScienceOpen disciplines: Medicine
                Keywords: randomised controlled trials,periodontics,dental implants,methods,methodological study,evidence-based dentistry
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: randomised controlled trials, periodontics, dental implants, methods, methodological study, evidence-based dentistry

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