Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) guidelines: a development protocol

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.

Preferred Reporting Items for Animal Studies in Endodontology: a development protocol

“…), the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) (Nagendrababu et al . ) and the Preferred Reporting Items for Laboratory studies in Endodontology (PRILE) (Nagendrababu et al . ).…”

“…The development of the PRIASE guidelines will adhere to the recommendations from the Guidance for Developers of Health Research Reporting Guidelines and follow similar methodology to that used to develop the guidelines for Preferred Reporting Items for Case reports in Endodontics (PRICE) (Nagendrababu et al 2019a), the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) (Nagendrababu et al 2019b) and the Preferred Reporting Items for Laboratory studies in Endodontology (PRILE) (Nagendrababu et al 2019c). The process will involve five phases with a steering committee being responsible for facilitating the development of the guidelines.…”

A protocol for developing reporting guidelines for laboratory studies in Endodontology

“…) and the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) guidelines (Nagendrababu et al . ) and will comply with recommendations from the Guidance for Developers of Health Research Reporting Guidelines (Moher et al . ).…”

PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration

“…Adhering to the PRIRATE 2020 guidelines will guide researchers and authors to design, conduct and produce clear, accurate, transparent and high-quality reports of randomized clinical trials in the field of Endodontics for the benefit of clinicians, policy makers and patients. Implementation of the guidelines will also help editors and referees to critically appraise the quality of randomized clinical trials following their submission to journals (Nagendrababu et al 2019).…”