Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.
Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.
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胃癌手术试验的核心结局集（GASTROS研究）：国际患者和医疗保健专业人士共识。
DOI：
10.1093/bjs/znab192
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发表时间：
2021-06-24
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影响因子：
--
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中科院分区：
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手术是可以治愈胃癌的主要治疗方法，但也有很大的风险。确定最佳手术入路应基于比较设计良好的试验的结果。目前，试验报告了不同的结果，使得证据的合成变得困难。为了解决这个问题，本研究的目的是制定一个核心结果集（COS）——一个对主要国际利益相关者很重要的标准化结果组——应该在该领域的未来试验中报告。研究的第一阶段包括从之前的试验和一系列患者访谈中确定潜在的重要结果。第二阶段涉及患者和医疗保健专业人员使用多语言国际德尔菲调查确定结果的优先级，该调查通知了国际共识会议，在会议上最终确定了COS。从先前报道的试验和患者访谈中确定了大约498个结果，并将其合理化为德尔菲调查中的56个项目。共有952名患者、外科医生和护士参加了第一轮调查，662人（70%）完成了第二轮调查。在共识会议之后，COS纳入了8个结果：无病生存、疾病特异性生存、手术相关死亡、复发、肿瘤切除完整性、总体生活质量、营养影响和“严重”不良事件。胃癌手术试验的COS已与国际患者和医疗保健专业人员共同开发。这是建议在该领域所有未来试验中使用的最小结果集，以改进试验设计和证据合成。胃癌手术试验结果的报道参差不齐，不能充分反映包括患者在内的关键利益相关者的优先事项。这导致结果报告偏倚和研究浪费。为了应对这些挑战，通过涉及患者和卫生保健专业人员的国际共识进程，制定了一个核心结果集——在未来试验中报告的至少一组至关重要的结果。
Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)—a standardized group of outcomes important to key international stakeholders—that should be reported by future trials in this field. Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and ‘serious’ adverse events. A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence. Outcomes in surgical trials for gastric cancer are reported heterogeneously and do not sufficiently reflect the priorities of key stakeholders, including patients. This contributes to outcome reporting bias and research waste. To address these challenges, a core outcome set—a minimum group of critically important outcomes to be reported in future trials— has been developed through an international consensus process involving patients and healthcare professionals.
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影响因子：
15.8
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
通讯作者：
Blazeby JM
影响因子：
4.3
作者：
Ryu, Seung Wan;Kim, In Ho
通讯作者：
Kim, In Ho
影响因子：
3.7
作者：
Gargon E;Gurung B;Medley N;Altman DG;Blazeby JM;Clarke M;Williamson PR
通讯作者：
Williamson PR
影响因子：
7.2
作者：
Dodd S;Clarke M;Becker L;Mavergames C;Fish R;Williamson PR
通讯作者：
Williamson PR
影响因子：
9.6
作者：
Potter, S.;Holcombe, C.;Ward, J. A.;Blazeby, J. M.
通讯作者：
Blazeby, J. M.