Lifson Alan R, Belloso Waldo H, Davey Richard T, Duprez Daniel, Gatell Jose M, Hoy Jennifer F, Krum Eric A, Nelson Ray, Pedersen Court, Perez George, Price Richard W, Prineas Ronald J, Rhame Frank S, Sampson James H, Worley John
Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota 55454-1015, USA.
HIV Clin Trials. 2010 Jul-Aug;11(4):205-19. doi: 10.1310/hct1104-205.
Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial.
SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT).
Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached.
HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.
在高效抗逆转录病毒治疗（HAART）时代，严重非艾滋病（SNA）疾病是发病和死亡的重要原因。我们描述了用于终点审查委员会（ERC）在START（一项多中心国际HIV临床试验）中使用的12种SNA事件的标准准则的制定情况。
SNA定义基于以下内容制定：（1）先前一项试验（SMART）的标准；（2）对已发表文献的回顾；（3）与ERC及其他内容专家进行的反复咨询和审查过程；（4）使用另一项试验（ESPRIT）中回顾性收集的报告对SNA标准草案进行评估。
给出了急性心肌梗死、充血性心力衰竭、需要药物治疗的冠状动脉疾病、冠状动脉血运重建、失代偿性肝病、深静脉血栓形成、糖尿病、终末期肾病、非艾滋病相关癌症、外周动脉疾病、肺栓塞和中风的最终标准。在ESPRIT中报告并经ERC审查的563起潜在SNA事件中，72%符合“确诊”标准，13%符合“可能”标准。ERC最初审查的病例中有28%在做出最终决定前需要后续讨论（裁定）。
将SNA疾病作为临床结局的HIV临床试验应具有标准化的SNA定义，以优化事件报告和验证，并且应由经验丰富的ERC进行审查并有裁定机会。
