Deborah Cook , Adam Deane , Joanna C. Dionne , François Lauzier , John C. Marshall , Yaseen M. Arabi , M. Elizabeth Wilcox , Marlies Ostermann , Abdulrahman Al-Fares , Diane Heels-Ansdell , Nicole Zytaruk , Lehana Thabane , Simon Finfer , for the REVISE Investigators and the Canadian Critical Care Trials Group
{"title":"主要试验结果的裁定：一项大型国际试验的校准工作和协议的结果","authors":"Deborah Cook , Adam Deane , Joanna C. Dionne , François Lauzier , John C. Marshall , Yaseen M. Arabi , M. Elizabeth Wilcox , Marlies Ostermann , Abdulrahman Al-Fares , Diane Heels-Ansdell , Nicole Zytaruk , Lehana Thabane , Simon Finfer , for the REVISE Investigators and the Canadian Critical Care Trials Group","doi":"10.1016/j.conctc.2024.101284","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Ascertainment of the severity of the primary outcome of upper gastrointestinal (GI) bleeding is integral to stress ulcer prophylaxis trials. This protocol outlines the adjudication process for GI bleeding events in an international trial comparing pantoprazole to placebo in critically ill patients (REVISE: <u>R</u>e-<u>Ev</u>aluating the Inhibition of <u>S</u>tress <u>E</u>rosions). The primary objective of the adjudication process is to assess episodes submitted by participating sites to determine which fulfil the definition of the primary efficacy outcome of clinically important upper GI bleeding. Secondary objectives are to categorize the bleeding severity if deemed not clinically important, and adjudicate the bleeding site, timing, investigations, and treatments.</p></div><div><h3>Methods</h3><p>Research coordinators follow patients daily for any suspected clinically important upper GI bleeding, and submit case report forms, doctors' and nurses’ notes, laboratory, imaging, and procedural reports to the methods center. An international central adjudication committee reflecting diverse specialty backgrounds conducted an initial calibration exercise to delineate the scope of the adjudication process, review components of the definition, and agree on how each criterion will be considered fulfilled. Henceforth, bleeding events will be stratified by study drug, and randomly assigned to adjudicator pairs (blinded to treatment allocation, and study center).</p></div><div><h3>Results</h3><p>Crude agreement, chance-corrected agreement, or chance-independent agreement if data have a skewed distribution will be calculated.</p></div><div><h3>Conclusions</h3><p>Focusing on consistency and accuracy, central independent blinded duplicate adjudication of suspected clinically important upper GI bleeding events will determine which events fulfil the definition of the primary efficacy outcome for this stress ulcer prophylaxis trial.</p></div><div><h3>Registration</h3><p>NCT03374800 (REVISE: <u>R</u>e-<u>Ev</u>aluating the Inhibition of <u>S</u>tress <u>E</u>rosions)</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000310/pdfft?md5=723dcea2f15ec43d36fb76712afd741c&pid=1-s2.0-S2451865424000310-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Adjudication of a primary trial outcome: Results of a calibration exercise and protocol for a large international trial\",\"authors\":\"Deborah Cook , Adam Deane , Joanna C. Dionne , François Lauzier , John C. Marshall , Yaseen M. Arabi , M. Elizabeth Wilcox , Marlies Ostermann , Abdulrahman Al-Fares , Diane Heels-Ansdell , Nicole Zytaruk , Lehana Thabane , Simon Finfer , for the REVISE Investigators and the Canadian Critical Care Trials Group\",\"doi\":\"10.1016/j.conctc.2024.101284\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Ascertainment of the severity of the primary outcome of upper gastrointestinal (GI) bleeding is integral to stress ulcer prophylaxis trials. This protocol outlines the adjudication process for GI bleeding events in an international trial comparing pantoprazole to placebo in critically ill patients (REVISE: <u>R</u>e-<u>Ev</u>aluating the Inhibition of <u>S</u>tress <u>E</u>rosions). The primary objective of the adjudication process is to assess episodes submitted by participating sites to determine which fulfil the definition of the primary efficacy outcome of clinically important upper GI bleeding. 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Adjudication of a primary trial outcome: Results of a calibration exercise and protocol for a large international trial
Background
Ascertainment of the severity of the primary outcome of upper gastrointestinal (GI) bleeding is integral to stress ulcer prophylaxis trials. This protocol outlines the adjudication process for GI bleeding events in an international trial comparing pantoprazole to placebo in critically ill patients (REVISE: Re-Evaluating the Inhibition of Stress Erosions). The primary objective of the adjudication process is to assess episodes submitted by participating sites to determine which fulfil the definition of the primary efficacy outcome of clinically important upper GI bleeding. Secondary objectives are to categorize the bleeding severity if deemed not clinically important, and adjudicate the bleeding site, timing, investigations, and treatments.
Methods
Research coordinators follow patients daily for any suspected clinically important upper GI bleeding, and submit case report forms, doctors' and nurses’ notes, laboratory, imaging, and procedural reports to the methods center. An international central adjudication committee reflecting diverse specialty backgrounds conducted an initial calibration exercise to delineate the scope of the adjudication process, review components of the definition, and agree on how each criterion will be considered fulfilled. Henceforth, bleeding events will be stratified by study drug, and randomly assigned to adjudicator pairs (blinded to treatment allocation, and study center).
Results
Crude agreement, chance-corrected agreement, or chance-independent agreement if data have a skewed distribution will be calculated.
Conclusions
Focusing on consistency and accuracy, central independent blinded duplicate adjudication of suspected clinically important upper GI bleeding events will determine which events fulfil the definition of the primary efficacy outcome for this stress ulcer prophylaxis trial.
Registration
NCT03374800 (REVISE: Re-Evaluating the Inhibition of Stress Erosions)
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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