| 1. |
- Nagendrababu, V, et al.
(author)
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Preferred Reporting Items for Diagnostic Accuracy Studies in Endodontics (PRIDASE) guidelines : a development protocol
- 2021
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In: International Endodontic Journal. - : John Wiley & Sons. - 0143-2885 .- 1365-2591. ; 54:7, s. 1051-1055
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Research review (peer-reviewed)abstract
- Diagnostic accuracy studies play an important role in informing clinical practice and patient management, by evaluating the ability of diagnostic testing and imaging to identify the presence or absence of a disease or condition. These studies compare the relative diagnostic strength of the test or device with a reference standard, therefore, guiding clinical decisions on the reliability of the test, the need for further tests, and whether to monitor or treat a particular condition. Inadequate and incomplete reporting of diagnostic accuracy studies can disguise methodological deficiencies and ultimately result in study bias and the inability to translate research findings into daily clinical practice. The Preferred Reporting Items for Diagnostic Accuracy Studies in Endodontics (PRIDASE) guidelines are being developed in order to improve the accuracy, transparency, completeness and reproducibility of diagnostic accuracy studies in the speciality of Endodontology. The aim of this paper is to report the process used to develop the PRIDASE guidelines based on a well-established consensus process. The project leaders (PD, VN) formed a steering committee of nine members (PD, VN, PA, AF, DR, SP, CK, MP, HD) to oversee and manage the project. The PRIDASE steering committee will develop the initial draft of the PRIDASE guidelines by adapting and modifying the Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015 guidelines, adding new items related specifically to the nature of Endodontics and incorporate the Clinical and Laboratory Images in Publication (CLIP) principles. The initial guidelines will consist of a series of domains and individual items and will be validated by the members of a PRIDASE Delphi Group (PDG) consisting of a minimum of 30 individuals who will evaluate independently the individual items based on two parameters: 'clarity' using a dichotomous scoring (yes/no) and 'suitability' for inclusion using a 9-point Likert Scale. The scores awarded by each member and any suggestions for improvement will be shared with the PDG to inform an iterative process that will result in a series of items that are clear and suitable for inclusion in the new PRIDASE guidelines. Once the PDG has completed its work, the steering committee will create a PRIDASE Meeting Group (PMG) of 20 individuals from around the world. Members of the PDG will be eligible to be the part of PMG. The draft guidelines and flowchart approved by the PDG will then be presented for further validation and agreement by the PMG. As a result of these discussions, the PRIDASE guidelines will be finalized and then disseminated to relevant stakeholders through publications and via the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website (http://pride-endodonticguidelines.org). Periodic updates to the PRIDASE guidelines will be made based on feedback from stakeholders and end-users.
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| 2. |
- Nagendrababu, V., et al.
(author)
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Preferred Reporting items for OBservational studies in Endodontics (PROBE) guidelines : a development protocol
- 2020
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In: International Endodontic Journal. - : John Wiley & Sons. - 0143-2885 .- 1365-2591. ; 53:9, s. 1199-1203
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Journal article (peer-reviewed)abstract
- Observational studies have a significant role in establishing the prevalence and incidence of diseases in populations, as well as determining the benefits and risks associated with health-related interventions. Observational studies principally encompass cohort, case-control, case series and cross-sectional designs. Inadequate reporting of observational studies is likely to have a negative impact on decision-making in day-to-day clinical practice; however, no reporting guidelines have been published for observational studies in Endodontics. The aim of this project is to develop reporting guidelines for authors when creating manuscripts describing observational studies in the field of Endodontology in an attempt to improve the quality of publications. The new guidelines for observational studies will be named: 'Preferred Reporting items for OBservational studies in Endodontics (PROBE)'. A steering committee was formed by the project leaders (PD, VN) to develop the guidelines through a five-phase consensus process. The steering committee will review and adapt items from the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement and the Clinical and Laboratory Images in Publications (CLIP) principles, as well as identify new items that add value to Endodontics. The steering committee will create a PROBE Delphi Group (PDG), consisting of 30 members across the globe to review and refine the draft checklist items and flowchart. The items will be assessed by the PDG on a nine-point Likert scale for relevance and inclusion. The agreed items will then be discussed by a PROBE Face-to-Face meeting group (PFMG) made up of 20 individuals to further refine the guidelines. After receiving feedback from the PFMG, the steering committee will pilot and finalize the guidelines. The approved PROBE guidelines will be disseminated through publication in relevant journals, and be presented at national and international conferences. The PROBE checklist and flowchart will be available and downloadable from the Preferred Reporting Items for study Designs in Endodontics (PRIDE) website: . The PROBE steering committee encourages clinicians, researchers, editors and peer reviewers to provide feedback on the PROBE guidelines to inform the steering group when the guidelines are updated.
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| 3. |
- Nagendrababu, V., et al.
(author)
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Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) guidelines: a development protocol
- 2019
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In: International Endodontic Journal. - : Wiley. - 0143-2885 .- 1365-2591. ; 52:7, s. 974-978
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Journal article (peer-reviewed)abstract
- Randomized clinical trials are acknowledged as the most appropriate methodology for demonstrating the efficacy or effectiveness of one intervention as opposed to another and thus play a major role in clinical decision-making. However, it is recognized that despite the existence of various guidelines, for example, the Consolidated Standards for Reporting Trials (CONSORT) statement, the quality of manuscripts describing randomized trials is often suboptimal. The current project aims to develop and disseminate new guidelines, Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE), to improve the planning and reporting quality of randomized trials in the field of Endodontics. The project leads (VN, PD) designed a robust process to develop the PRIRATE guidelines. At first, a steering committee of eight members, including the project leads, was formed. Thereafter, a five-stage consensus process will be followed: initial steps, pre-meeting activities, face-to-face consensus meeting, post-meeting activities and post-publication activities. The steering committee will develop the first draft of the PRIRATE guidelines by identifying relevant and important items from various sources including the CONSORT guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles. This will be followed by the establishment of a PRIRATE Delphi Group (PDG) consisting of 30 members. The individual items of the first draft of the PRIRATE guidelines developed by the steering committee will be evaluated and scored on a 9-point Likert scale by the PDG members. Items with a score of seven and above by more than 70% of PDG members will be included in the second draft of the guidelines, and the Delphi process will be repeated until each item fulfils the set conditions. After obtaining consensus from the PDG, the PRIRATE guidelines will be discussed by 20 selected individuals within a PRIRATE Face-to-face Consensus Meeting Group (PFCMG) to arrive at a final consensus. The final PRIRATE guidelines will be accompanied with an explanation and elaboration document developed by the steering committee and approved by six members, three from the PDG and three from the PFCMG. The PRIRATE guidelines will be published in journals and actively disseminated to educational institutions, national and international academic societies and presented at scientific meetings. The steering committee will periodically revise and update the PRIRATE guidelines based on feedback from stakeholders.
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| 4. |
- Nagendrababu, Venkateshbabu, et al.
(author)
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PRIDASE 2024 guidelines for reporting diagnostic accuracy studies in endodontics : A consensus‐based development
- 2024
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In: International Endodontic Journal. - : John Wiley & Sons. - 0143-2885 .- 1365-2591. ; 57:8, s. 996-1005
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Journal article (peer-reviewed)abstract
- Studies investigating the accuracy of diagnostic tests should provide data on how effectively they identify or exclude disease in order to inform clinicians responsible for managing patients. This consensus-based project was undertaken to develop reporting guidelines for authors submitting manuscripts, which describe studies that have evaluated the accuracy of diagnostic tests in endodontics. These guidelines are known as the Preferred Reporting Items for Diagnostic Accuracy Studies in Endodontics (PRIDASE) 2024 guidelines. A nine-member steering committee created an initial checklist by integrating and modifying items from the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 checklist and the Clinical and Laboratory Images in Publications (CLIP) principles, as well as adding a number of new items specific to the specialty of endodontics. Thereafter, the steering committee formed the PRIDASE Delphi Group (PDG) and the PRIDASE Online Meeting Group (POMG) in order to collect expert feedback on the preliminary draft checklist. Members of the Delphi group engaged in an online Delphi process to reach consensus on the clarity and suitability of the items in the checklist. The online meeting group then held an in-depth discussion on the online Delphi-generated items via the Zoom platform on 20 October 2023. According to the feedback obtained, the steering committee revised the PRIDASE checklist, which was then piloted by several authors when preparing manuscripts describing diagnostic accuracy studies in endodontics. Feedback from this process resulted in the final version of the PRIDASE 2024 checklist, which has 11 sections and 66 items. Authors are encouraged to use the PRIDASE 2024 guidelines when developing manuscripts on diagnostic accuracy in endodontics in order to improve the quality of reporting in this area. Editors of relevant journals will be invited to include these guidelines in their instructions to authors.
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| 5. |
- Nagendrababu, V., et al.
(author)
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PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: a consensus-based development
- 2020
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In: International Endodontic Journal. - : Wiley. - 0143-2885 .- 1365-2591. ; 53:6, s. 764-773
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Journal article (peer-reviewed)abstract
- In evidence-based health care, randomized clinical trials provide the most accurate and reliable information on the effectiveness of an intervention. This project aimed to develop reporting guidelines, exclusively for randomized clinical trials in the dental specialty of Endodontology, using a well-documented, validated consensus-based methodology. The guidelines have been named Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020. A total of eight individuals (PD, VN, HD, LB, TK, JJ, EP and SP), including the project leaders (PD and VN) formed a steering committee. The committee developed a checklist based on the items in the Consolidated Standards of Reporting Trials (CONSORT) guidelines and Clinical and Laboratory Images in Publications (CLIP) principles. A PRIRATE Delphi Group (PDG) and PRIRATE Face-to-Face Meeting group (PFMG) were also formed. Thirty PDG members participated in the online Delphi process and achieved consensus on the checklist items and flowchart that make up the PRIRATE guidelines. The guidelines were discussed at a meeting of the PFMG at the 19th European Society of Endodontology (ESE) Biennial congress, held on 13 September 2019 in Vienna, Austria. A total of 21 individuals from across the globe and four steering committee members (PD, VN, HD and LB) attended the meeting. As a consequence of the discussions, the guidelines were modified and then piloted by several authors whilst writing a manuscript. The PRIRATE 2020 guidelines contain a checklist consisting of 11 sections and 58 individual items as well as a flowchart, considered essential for authors to include when writing manuscripts for randomized clinical trials in Endodontics.
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| 6. |
- Nagendrababu, V., et al.
(author)
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PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration
- 2020
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In: International Endodontic Journal. - : Wiley. - 0143-2885 .- 1365-2591. ; 53:6, s. 774-803
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Journal article (peer-reviewed)abstract
- Well-designed and properly conducted randomized clinical trials provide a true estimate of the effects of interventions and are acknowledged as the gold standard in terms of clinical study design. However, the quality of randomized clinical trials published in the field of Endodontics is suboptimal. The Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for Endodontics by integrating and adapting the CONsolidated Standards of Reporting Trials (CONSORT) statement and Clinical and Laboratory Images in Publications (CLIP) principles, through an accepted and well-documented consensus process. Full implementation of the PRIRATE 2020 guidelines will minimize potential sources of bias and thus enhance the standard of manuscripts submitted for publication, which will ultimately improve the reporting of randomized clinical trials in Endodontics. The aim of this document is to provide an explanation for each item in the PRIRATE 2020 checklist and flowchart with examples from the literature in order to help authors understand their rationale and significance. A link to this PRIRATE 2020 explanation and elaboration document is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website at .
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