Defining Non-inferiority Margins for Quality of Surgical Resection for Rectal Cancer: A Delphi Consensus Study
Defining Non-inferiority Margins for Quality of Surgical Resection for Rectal Cancer: A Delphi Consensus Study
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DOI：
10.1245/s10434-018-6639-7
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发表时间：
2018-10-01
影响因子：
3.7
通讯作者：
Baxter, Nancy N.
中科院分区：
文献类型：
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作者：
Acuna, Sergio A.;Chesney, Tyler R.;Baxter, Nancy N.
在比较腹腔镜手术和开腹直肠癌手术的非劣效性随机临床试验（RCT）中，手术切除质量指标（QSRM）已被用作长期肿瘤学结果的替代指标。然而，QSRM 的非劣效性边界 (Delta(NI)) 之前尚未定义。使用两轮基于网络的 Delphi 来定义四种 QSRM 的 Delta(NI)：正圆周切除边界 (CRM)、不完整的直肠系膜切除平面 (PME)、正远端切除边界 (DRM) 以及这些结果的组合。总共邀请了 130 名国际直肠癌专家（68 名外科医生、20 名肿瘤内科医生、16 名放射肿瘤科医生和 26 名病理学家）参加。专家们收到了总结 QSRM 与长期结局之间关系的证据综合，以及开放手术手术切除结局的汇总质量，并被要求提供所有结局的 Delta(NI)，以平衡微创手术的风险和收益。 72 名专家参与其中：57 名完成了初始调查问卷，58 名完成了修订后的调查问卷，其中 43 名专家参与了两轮。所有单独的 QSRM Delta(NI) 均已达成共识，但复合材料尚未达成共识。在比较治疗直肠癌的手术干预措施时，阳性 CRM 比例的平均值（标准差）Delta(NI) 绝对差异为 2.33% (1.59%)：不完全 PME 为 2.85% (1.83%)；积极 DRM 为 1.28% (1.13%)；复合材料为 2.71% (2.28%)。然而，对于综合结果的看法差异很大。基于网络的 Delphi 过程是生成 Delta(NI) 来评估新型手术干预措施的可行方法。生成的直肠癌 QSRM 的 Delta(NI) 可用于未来的随机对照试验和非劣效性荟萃分析。
Quality of surgical resection metrics (QSRMs) have been used as surrogates for long-term oncologic outcomes in non-inferiority randomized clinical trials (RCTs) comparing laparoscopic and open surgery for rectal cancer. However, non-inferiority margins (Delta(NI)) for QSRMs have not been previously defined.A two-round, web-based Delphi was used to define Delta(NI) for four QSRMs: positive circumferential resection margin (CRM), incomplete plane of mesorectal excision (PME), positive distal resection margin (DRM), and a composite of these outcomes. Overall, 130 international experts in rectal cancer (68 surgeons, 20 medical oncologists, 16 radiation oncologists, and 26 pathologists) were invited to participate. Experts were presented with evidence syntheses summarizing the association between QSRMs and long-term outcomes, and pooled quality of surgical resection outcomes for open surgery, and were asked to provide Delta(NI) for all outcomes balancing the risks and benefits of minimally invasive surgery.Seventy-two experts participated: 57 completed the initial questionnaire and 58 completed the revised questionnaire, with 43 participating in both rounds. Consensus was reached for all individual QSRM Delta(NI) but not for the composite. The mean (standard deviation) Delta(NI) was an absolute difference of 2.33% (1.59%) for the proportion of positive CRMs when comparing surgical interventions for the treatment of rectal cancer: 2.85% (1.83%) for incomplete PME; 1.28% (1.13%) for positive DRMs; and 2.71% (2.28%) for the composite. However, opinions varied widely for the composite outcome.Web-based Delphi processes are a feasible approach to generate Delta(NI) to evaluate novel surgical interventions. The generated Delta(NI) for QSRMs for rectal cancer can be used for future RCTs and non-inferiority meta-analyses.