Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.
Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.
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DOI：
10.1371/journal.pmed.1002071
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发表时间：
2016-08
期刊：
影响因子：
15.8
通讯作者：
Blazeby JM
中科院分区：
文献类型：
--
作者：
McNair AG;Whistance RN;Forsythe RO;Macefield R;Rees J;Pullyblank AM;Avery KN;Brookes ST;Thomas MG;Sylvester PA;Russell A;Oliver A;Morton D;Kennedy R;Jayne DG;Huxtable R;Hackett R;Dutton SJ;Coleman MG;Card M;Brown J;Blazeby JM
结直肠癌(CRC)是世界范围内发病率和死亡率的主要原因。外科治疗很常见，非常需要改善这种护理的提供。评估手术的黄金标准是在设计良好的随机对照试验(RCT)内；然而，RCT的影响因缺乏协调的结果测量和报告而减弱。这些问题的一个解决方案是制定一个商定的标准“核心”结果集，在所有试验中进行测量，以促进交叉研究比较、荟萃分析，并将结果报告偏差降至最低。这项研究确定了结直肠癌手术的核心结果集。这项COS的范围包括结直肠癌手术干预的临床有效性试验。排除的是非手术肿瘤干预。通过系统的文献回顾和患者访谈确定了对患者和专业人员重要的潜在结果。所有结果都被两个独立的研究人员逐字转录并归类到不同的领域。这为问卷调查提供了依据，该调查要求来自英国CRC中心的利益相关者(患者和专业人员)对每个领域的重要性进行评级。受访者根据小组反馈(德尔菲法)重新进行调查。被评为不太重要的结果在每一轮调查后根据预先定义的标准被丢弃，其余的结果在三次协商一致的会议上被考虑；两次涉及国际专业人员，另一次涉及患者。使用改进的名义分组技术来获得最终共识。数据来源确定了1216例结直肠癌手术的结果，这些结果构成了91领域的调查问卷。第一轮问卷来自81个中心中的63个(78%)，其中包括90名专业人员，以及267名患者中的97名(35%)。所有利益相关者的第二轮回复率都很高(80%)。对答复的分析导致在第一次和第二次调查后分别保留了45个和23个结果领域。协商一致的会议产生了12个域名COS的协议。这包括五个围手术期结果域(包括吻合口漏)，四个生活质量结果域(包括粪便紧迫症和大小便失禁)，以及三个肿瘤学结果域(包括长期生存)。这项研究使用稳健的共识方法来制定用于结直肠癌外科试验的核心结果集。现在有必要在研究实践中验证这一套的使用。Angus McNair和他的同事描述了12个结果领域，这些领域构成了结直肠外科研究的核心结果集。
Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard “core” set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice. Angus McNair and colleagues describe 12 outcome domains that form a core outcome set for colorectal surgery research.