识别成人心脏骤停治疗随机对照试验中的重要差距：对已发表文献的系统评价
Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments: A Systematic Review of the Published Literature.
作者信息
Sinha Shashank S, Sukul Devraj, Lazarus John J, Polavarapu Vivek, Chan Paul S, Neumar Robert W, Nallamothu Brahmajee K
机构信息
From the Department of Internal Medicine, Division of Cardiovascular Medicine, Samuel and Jean Frankel Cardiovascular Center (S.S.S., D.S., J.J.L., V.P., B.K.N.) and Department of Emergency Medicine (R.W.N.), Institute for Healthcare Policy and Innovation (S.S.S., D.S., B.K.N.), Michigan Center for Health Analytics and Medical Prediction (S.S.S., D.S., B.K.N.), and Michigan Center for Integrative Research in Critical Care (S.S.S., R.W.N., B.K.N.), University of Michigan, Ann Arbor; Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City (P.S.C.); and VA Health Services Research and Development Center of Innovation, VA Ann Arbor Healthcare System, MI (B.K.N.).
出版信息
Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):749-756. doi: 10.1161/CIRCOUTCOMES.116.002916. Epub 2016 Oct 18.
BACKGROUND
Cardiac arrest is a major public health concern worldwide. The extent and types of randomized controlled trials (RCT)-our most reliable source of clinical evidence-conducted in these high-risk patients over recent years are largely unknown.
METHODS AND RESULTS
We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on the acute treatment of nontraumatic cardiac arrest in adults. We then extracted data on the setting of study populations, types and timing of interventions studied, risk of bias, outcomes reported, and how these factors have changed over time. Over this 20-year period, 92 RCTs were published containing 64 309 patients (median, 225.5 per trial). Of these, 81 RCTs (88.0%) involved out-of-hospital cardiac arrest, whereas 4 (4.3%) involved in-hospital cardiac arrest and 7 (7.6%) included both. Eighteen RCTs (19.6%) were performed in the United States, 68 (73.9%) were performed outside the United States, and 6 (6.5%) were performed in both settings. Thirty-eight RCTs (41.3%) evaluated drug therapy, 39 (42.4%) evaluated device therapy, and 15 (16.3%) evaluated protocol improvements. Seventy-four RCTs (80.4%) examined interventions during the cardiac arrest, 15 (16.3%) examined post cardiac arrest treatment, and 3 (3.3%) studied both. Overall, reporting of the risk of bias was limited. The most common outcome reported was return of spontaneous circulation: 86 (93.5%) with only 22 (23.9%) reporting survival beyond 6 months. Fifty-three RCTs (57.6%) reported global ordinal outcomes, whereas 15 (16.3%) reported quality-of-life. RCTs in the past 5 years were more likely to be focused on protocol improvements and postcardiac arrest care.
CONCLUSIONS
Important gaps in RCTs of cardiac arrest treatments exist, especially those examining in-hospital cardiac arrest, protocol improvement, postcardiac arrest care, and long-term or quality-of-life outcomes.
背景
心脏骤停是全球主要的公共卫生问题。近年来，针对这些高危患者开展的随机对照试验（RCT，我们最可靠的临床证据来源）的范围和类型很大程度上尚不明确。
方法与结果
我们进行了一项系统评价，检索了1995年至2014年发表在PubMed、EMBASE、Scopus、Web of Science和Cochrane图书馆中的所有聚焦于成人非创伤性心脏骤停急性治疗的随机对照试验。然后，我们提取了关于研究人群背景、所研究干预措施的类型和时机、偏倚风险、报告的结局以及这些因素如何随时间变化的数据。在这20年期间，共发表了92项随机对照试验，纳入64309例患者（中位数为每项试验225.5例）。其中，81项随机对照试验（88.0%）涉及院外心脏骤停，4项（4.3%）涉及院内心脏骤停，7项（7.6%）两者均有涉及。18项随机对照试验（19.6%）在美国进行，68项（73.9%）在美国以外进行，6项（6.5%）在两种环境中均进行。38项随机对照试验（41.3%）评估了药物治疗，39项（42.4%）评估了器械治疗，15项（16.3%）评估了方案改进。74项随机对照试验（80.4%）研究了心脏骤停期间的干预措施，15项（16.3%）研究了心脏骤停后治疗，3项（3.3%）两者均研究。总体而言，偏倚风险的报告有限。最常报告的结局是自主循环恢复：86项试验（93.5%），只有22项（23.9%）报告了6个月以上的生存率。53项随机对照试验（57.6%）报告了总体序贯结局，15项（16.3%）报告了生活质量。过去5年的随机对照试验更有可能聚焦于方案改进和心脏骤停后护理。
结论
心脏骤停治疗的随机对照试验存在重要差距，尤其是那些研究院内心脏骤停、方案改进、心脏骤停后护理以及长期或生活质量结局的试验。
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