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The standards of reporting trials in pets (PetSORT): Explanation and elaboration.

ABSTRACT: Well-designed randomized controlled trials (RCTs) provide the best evidence of the primary research designs for evaluating the effectiveness of interventions. However, if RCTs are incompletely reported, the methodological rigor with which they were conducted cannot be reliably evaluated and it may not be possible to replicate the intervention. Missing information also may limit the reader's ability to evaluate the external validity of a trial. Reporting guidelines are available for clinical trials in human healthcare (CONSORT), livestock populations (REFLECT), and preclinical experimental research involving animals (ARRIVE 2.0). The PetSORT guidelines complement these existing guidelines, providing recommendations for reporting controlled trials in pet dogs and cats. The rationale and scientific background are explained for each of the 25 items in the PetSORT reporting recommendations checklist, with examples from well-reported trials.

SUBMITTER: Sargeant JM

PROVIDER: S-EPMC10103631 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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The standards of reporting trials in pets (PetSORT): Explanation and elaboration.

Sargeant Jan M JM Ruple Audrey A Selmic Laura E LE O'Connor Annette M AM

Frontiers in veterinary science 20230330

Well-designed randomized controlled trials (RCTs) provide the best evidence of the primary research designs for evaluating the effectiveness of interventions. However, if RCTs are incompletely reported, the methodological rigor with which they were conducted cannot be reliably evaluated and it may not be possible to replicate the intervention. Missing information also may limit the reader's ability to evaluate the external validity of a trial. Reporting guidelines are available for clinical tria ...[more]

PMID: 37065227

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Project description:BackgroundClear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.Methods and findingsWe generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.ConclusionsCONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.

Project description:Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete. The international consensus-based CONSORT-DEFINE (Consolidated Standards for Reporting Trials Dose-finding Extension) statement, an extension of the CONSORT statement for randomised trials, was developed to improve the reporting of EPDF trials. The CONSORT-DEFINE statement introduced 21 new items and modified 19 existing CONSORT items.This CONSORT-DEFINE Explanation and Elaboration (E&E) document provides important information to enhance understanding and facilitate the implementation of the CONSORT-DEFINE checklist. For each new or modified checklist item, we provide a detailed description and its rationale with supporting evidence, and present examples from EPDF trial reports published in peer-reviewed scientific journals. When reporting the results of EPDF trials, authors are encouraged to consult the CONSORT-DEFINE E&E document, together with the CONSORT and CONSORT-DEFINE statement papers, and adhere to their recommendations. Widespread adoption of the CONSORT-DEFINE statement is likely to enhance the reporting quality of EPDF trials, thus facilitating the peer review of such studies and their appraisal by researchers, regulators, ethics committee members, and funders.FundingThis work is a further extension of the CONSORT-DEFINE study, which was funded by the UK Medical Research Council (MRC)-National Institute for Health and Care Research (NIHR) Methodology Research Programme (MR/T044934/1). The Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU) receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351; CTUQQR-Dec 22/100 004), which has contributed to accelerating the advancement and successful completion of this work.

Dataset Information

The standards of reporting trials in pets (PetSORT): Explanation and elaboration.

Publications

The standards of reporting trials in pets (PetSORT): Explanation and elaboration.

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