Department of Anaesthesia, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Ireland; Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.
Department of Anaesthesia, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Ireland.
Br J Anaesth. 2018 Jul;121(1):38-44. doi: 10.1016/j.bja.2018.03.020. Epub 2018 May 1.
The Standardising Endpoints for Perioperative Medicine group was established to derive an appropriate set of endpoints for use in clinical trials related to anaesthesia and perioperative medicine. Anaesthetic or analgesic technique during cancer surgery with curative intent may influence the risk of recurrence or metastasis. However, given the current equipoise in the existing literature, prospective, randomised, controlled trials are necessary to test this hypothesis. As such, a cancer subgroup was formed to derive endpoints related to research in onco-anaesthesia based on a current evidence base, international consensus and expert guidance.
We undertook a systematic review to identify measures of oncological outcome used in the oncological, surgical, and wider literature. A multiround Delphi consensus process that included up to 89 clinician-researchers was then used to refine a recommended list of endpoints.
We identified 90 studies in a literature search, which were the basis for a preliminary list of nine outcome measures and their definitions. A further two were added during the Delphi process. Response rates for Delphi rounds one, two, and three were 88% (n=9), 82% (n=73), and 100% (n=10), respectively. A final list of 10 defined endpoints was refined and developed, of which six secured approval by ≥70% of the group: cancer health related quality of life, days alive and out of hospital at 90 days, time to tumour progression, disease-free survival, cancer-specific survival, and overall survival (and 5-yr overall survival).
Standardised endpoints in clinical outcomes studies will support benchmarking and pooling (meta-analysis) of trials. It is therefore recommended that one or more of these consensus-derived endpoints should be considered for inclusion in clinical trials evaluating a causal effect of anaesthesia-analgesia technique on oncological outcomes.
标准化围手术期医学终点研究组的成立旨在为与麻醉和围手术期医学相关的临床试验确定一套适当的终点。具有治愈意图的癌症手术期间的麻醉或镇痛技术可能会影响复发或转移的风险。然而，鉴于现有文献中的当前平衡状态，需要进行前瞻性、随机、对照试验来检验这一假设。因此，成立了一个癌症亚组，根据当前的证据基础、国际共识和专家指导，制定与肿瘤麻醉研究相关的终点。
我们进行了系统评价，以确定在肿瘤学、外科和更广泛的文献中使用的肿瘤学结果测量方法。然后，使用多轮 Delphi 共识过程，最多包括 89 名临床医生-研究人员，对推荐的终点清单进行了细化。
在文献检索中，我们确定了 90 项研究，这些研究为初步的 9 项结果测量及其定义清单提供了依据。在 Delphi 过程中又增加了两项。Delphi 第一轮、第二轮和第三轮的回复率分别为 88%（n=9）、82%（n=73）和 100%（n=10）。最终确定了 10 个定义明确的终点，并对其进行了细化和开发，其中 6 个得到了≥70%的小组批准：癌症健康相关生活质量、90 天内存活和出院天数、肿瘤进展时间、无病生存率、癌症特异性生存率和总生存率（以及 5 年总生存率）。
临床结局研究中的标准化终点将支持试验的基准测试和汇总（荟萃分析）。因此，建议在评估麻醉-镇痛技术对肿瘤学结果的因果影响的临床试验中考虑使用这些共识衍生的终点之一或多个。
