各位好！今天与大家分享一篇近期发表在Annals of surg有关择期肿瘤手术不同风险人群术后积极随访与短期并发症、长期生存的研究。作为传统临床实效研究的一个范本，一起从这篇文章来看看这种干预策略对外科术后质量评价与患者预后的影响。
A Randomized, Controlled Trial Evaluating Perioperative Risk-Stratification and Risk-Based, Protocol-Driven Management After Elective Major Cancer Surgery
Esnaola, Nestor F. MD, MPH, MBA*,†; Chelluri, Raju MD, MS†; Castellanos, Jason MD, MS†; Altman, Ariella MD†; Chen, David Y.T. MD†; Chu, Christina MD†,‡; Farma, Jeffrey M. MD†; Haber, Alan MD§; Sheriff, Fathima MD∥; Huang, Christine MS¶; Kutikov, Alexander MD†; Patel, Sameer MD†; Patrick, Kenneth MD§; Reddy, Sanjay MD†; Rubin, Stephen MD†; Viterbo, Rosalia MD†; Ridge, John A MD, PhD†; Edelman, Martin MD#; Ross, Eric PhD¶; Smaldone, Marc MD†; Uzzo, Robert G. MD, MBA†
Annals of Surgery 24 July 2024
Objective: We evaluated the efficacy of risk-based, protocol-driven management versus (vs) usual management after elective major cancer surgery to reduce 30-day rates of postoperative death or serious complications (DSC) .
目的：本研究评估了择期重大癌症手术后基于风险、方案驱动的管理与常规管理相比的有效性，以降低30天术后死亡或严重并发症（DSA）的发生率。
Background Data: Major cancer surgery is associated with significant perioperative risks which result in worse long-term outcomes.
背景：癌症大手术与显着的围手术期风险相关，从而导致更差的长期结局。
Methods: Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and co-management vs usual management. The primary study outcome was 30-day rate of DSC. Additional outcomes included complications, adverse events, health care utilization, health-related quality of life (HRQOL), and disease-free and overall survival (DFS and OS).
方法：计划接受择期重大癌症手术的成年人被分层/随机分配到基于风险的不断升级的护理、监测和共同管理水平与常规管理水平。主要研究结果是30天的DSA率。其他结果包括并发症、不良事件、医疗保健利用率、健康相关生活质量（HRQOL）以及无病生存期和总体生存期（DFS和OS）。
Results: Between August 2014 and June 2020, 1529 patients were enrolled and randomly allocated to the study arms; 738 patients in the Intervention Arm and 732 patients in the Control Arm were eligible for analysis. 30-day rate of DSC with the intervention was 15.0% (95% CI, 12.5-17.6%) vs 14.1%, (95% CI, 11.6-16.6%) with usual management (P=0.65). There were no differences in 30-day rates of complications or adverse events (including return to the operating room); postoperative length of stay; rate of discharge to home; or 30, 60, or 90-day HRQOL or rates of hospital readmission or receipt of anti-neoplastic therapy between the study arms. At median follow-up of 48 months, OS (P=0.57) and DFS (P=0.91) were similar.
结果：2014年8月至2020年6月期间，入组了1529名患者并随机分配至研究组;干预组中有738名患者和对照组中有732名患者有资格参加分析。30-干预后的DSA日率为15.0%（95%CI，12.5-17.6%），而常规治疗后的DSA日率为14.1%（95%CI，11.6-16.6%）（P=0.65）。研究组之间的30天并发症或不良事件发生率（包括返回手术室）;术后住院时间;出院回家率;或30、60或90天HRQOL或再入院率或接受抗肿瘤治疗没有差异。中位随访48个月时，OS（P=0.57）和DFS（P=0.91）相似。
Conclusions: Risk-based, protocol-driven management did not reduce 30-day rate of DSC after elective major cancer surgery compared to usual management, nor improve postoperative health care utilization, HRQOL, or cancer outcomes. Trials are needed to identify cost-effective, tailored perioperative strategies to optimize outcomes after major cancer surgery.
结论：与通常管理相比，基于风险、方案驱动的管理并没有降低择期重大癌症手术后30天的DSA率，也没有改善术后医疗保健利用率、HRQOL或癌症结局。需要进行试验来确定具有成本效益、量身定制的围手术期策略，以优化重大癌症手术后的结局。
1.众所周知，纯外科临床研究在现代外科日臻完善的趋势下，逐渐式微。药物和生物学突飞猛进的当下，让我们一起再看看曾经那些旨在监测患者术后并发症和短期结局的稀奇古怪的评分。
2.上细节：
首先本文是上一个十年开展的2014-2020，旨在改善择期肿瘤手术术后手术风险评估，题目一看确实感觉比较亮眼。设计上将术前风险和术后风险综合后，对术后的随诊策略进行不同类型的干预，确有亮点。
其次，仔细看术后的干预策略其实就是更密集的打电话，当然作者写的特别到位，拔高了术后密集随访的四大理论意义。
①help with medication self-management, a self-managed, patient-centered record to facilitate information transfers; ②timely post-discharge follow-up, and ③education about relevant “red flags” indicative of worsening of their condition; ④identified problems were addressed via a series of phone calls and visits with a “transition coach”.
第三，结论上虽然是阴性结果，其实也从侧面反映出术后风险模型的临床显著性所需要的样本量是相当大。无论是现在流行的PRO还是术前Risk score的分层干预，到底什么才是最好的（经济高效）的肿瘤手术术后随访模式，值得思考。
3. 围绕Frail的泛外科已经很难满足临床需求了，肿瘤外科多病种合并症管理需要更扎实的数据基础。
目录
1. INTRODUCTION
2. Methods
2.1 Study Design (Supplemental Figure 1)
2.2 Patients, Stratification, and Randomization (Supplemental Table 1)
2.3 Treatment Groups (Table 1)
2.4 Outcomes and Data Collection
2.5 Statistical Analysis
3. Results (Figure 1)(Table 2-4)(Figure 2-3)
4. Discussion
— 图表汇总—
2.1 Study Design
Supplemental Figure 1. Trial Schema
2.2 Patients, Stratification, and Randomization
Supplemental Table 1
2.3 Treatment Groups
Table 1. Inpatient and outpatient components of risk-based, protocol-driven management in the Intervention Arm based on perioperative risk stratification groups (i.e., combined results of preoperative and postoperative risk stratifications).
3. Results
Figure 1. CONSORT diagram of patient enrollment.
Table 2. Characteristics of patients in each study arm.
Table 3. Risk stratification groups in each study arm.
Table 4. Study outcomes.
Figure 2. Change in health related quality of life subscales at 30- day follow-up in the Control versus Intervention Arms.
Figure 3. Kaplan-Meier curves for overall survival in the Control versus Intervention Arms.
