Cook Deborah, Deane Adam, Dionne Joanna C, Lauzier François, Marshall John C, Arabi Yaseen M, Wilcox M Elizabeth, Ostermann Marlies, Al-Fares Abdulrahman, Heels-Ansdell Diane, Zytaruk Nicole, Thabane Lehana, Finfer Simon
McMaster University, Hamilton, Canada.
University of Melbourne, Melbourne, Australia.
Contemp Clin Trials Commun. 2024 Mar 5;39:101284. doi: 10.1016/j.conctc.2024.101284. eCollection 2024 Jun.
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.
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).
Crude agreement, chance-corrected agreement, or chance-independent agreement if data have a skewed distribution will be calculated.
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.
NCT03374800 (REVISE: Re-Evaluating the Inhibition of Stress Erosions).
确定上消化道（GI）出血这一主要结局的严重程度是应激性溃疡预防试验不可或缺的一部分。本方案概述了一项国际试验中GI出血事件的判定过程，该试验比较了泮托拉唑与安慰剂在危重症患者中的疗效（REVISE：重新评估应激性糜烂的抑制作用）。判定过程的主要目的是评估参与研究的各中心提交的病例，以确定哪些符合具有临床意义的上消化道大出血这一主要疗效结局的定义。次要目的是在判定出血事件不具有临床意义时对出血严重程度进行分类，并判定出血部位、时间、检查及治疗情况。
研究协调员每天对患者进行随访，以发现任何疑似具有临床意义的上消化道大出血情况，并将病例报告表、医生和护士记录、实验室、影像学及诊疗报告提交至方法中心。一个由不同专业背景人员组成的国际中央判定委员会进行了初步校准工作，以界定判定过程的范围、审查定义的各个组成部分，并就如何认定各标准已得到满足达成一致意见。此后，出血事件将按研究药物进行分层，并随机分配给判定人员对（对治疗分配和研究中心不知情）。
将计算粗一致性、校正机遇一致性，或在数据分布呈偏态时计算与机遇无关的一致性。
聚焦于一致性和准确性，对疑似具有临床意义的上消化道大出血事件进行中央独立双盲判定，将确定哪些事件符合该应激性溃疡预防试验主要疗效结局的定义。
NCT03374800（REVISE：重新评估应激性糜烂的抑制作用）
