Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions A statement from the ESA-ESICM joint taskforce on perioperative outcome measures
Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions A statement from the ESA-ESICM joint taskforce on perioperative outcome measures
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DOI：
10.1097/eja.0000000000000118
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发表时间：
2015-02-01
影响因子：
3.6
通讯作者：
Pearse, Rupert M.
中科院分区：
文献类型：
--
作者：
Jammer, Ib;Wickboldt, Nadine;Pearse, Rupert M.
有必要进行大型试验，以测试围手术期医学领域干预措施的临床有效性。此类试验中使用的临床结局指标必须可靠、定义明确且与患者相关。我们的目标是制定标准，使用临床结果的措施，以加强围手术期医学研究的方法质量。使用PubMed进行了文献检索，并邀请世界各地的意见领袖提名他们认为该小组应该考虑的论文。工作队成员审查了相关文章的全文，然后进行了讨论，以便就所需标准达成共识。报告随后分发给舆论领袖，供其评论和审查。本报告描述了22起个体不良事件的定义，以及每起事件的严重程度分级系统。此外，还确定了4项复合结局指标，旨在评价术后结局。该小组还就评估医疗资源使用和生活质量的四项结果指标的标准达成一致。提供了使用这些结果指标的指导，特别强调适当的随访时间。本报告为围手术期医学的大型临床试验提供了明确定义和患者相关的结局指标。这些结局指标也可用于临床稽查。本报告旨在补充而非取代其他相关工作，以改善特定外科手术后的临床结局评估。
There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.