Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
JAMA Netw Open. 2022 Mar 1;5(3):e221766. doi: 10.1001/jamanetworkopen.2022.1766.
The association of surgeons' and hospitals' operative volumes with postoperative patient outcomes has been studied for decades and holds important policy implications; however, in many volume-outcome analyses, this association is described without the envisioning of a clear intervention, which often introduces unintentional bias. Acting on such results may lead to unintended consequences from policy interventions or patient recommendations.
To specify how (hypothetical) target trials would be designed to estimate the association between postoperative mortality of patients undergoing operations and a range of surgeon and hospital volume conditions and then to emulate these trials by using observational data.
DESIGN, SETTING, AND PARTICIPANTS: This observational data analysis emulated 4 hypothetical target trials of increasing complexity, ranging from a poorly defined trial that would randomly assign participants only to surgeon volume to one that would randomly assign participants to surgeon volume, hospital volume, and specific surgeon and hospital. This population-based cohort study included 9136 Medicare beneficiaries with a first diagnosis of pancreatic malignant neoplasm who did not require neoadjuvant therapy and underwent pancreatectomy between January 1, 2012, and September 30, 2016. Data analysis was performed between September 1, 2019, and October 8, 2021.
Number of pancreatectomies performed by surgeon and hospital during the prior year.
Ninety-day mortality.
The analyses included 9136 Medicare beneficiaries treated by 1358 surgeons at 697 hospitals; median age was 73.3 years (IQR, 69.1-78.1 years), and 4642 were men (51%). When trials with poorly defined interventions on surgeon volume were emulated, the estimated 90-day mortality was 7.9% (95% CI, 6.4%-9.4%) for lower-volume surgeons and 5.2% (95% CI, 2.7%-10.9%) for higher-volume surgeons. When trials with better-defined interventions were emulated, the difference was reduced: 7.8% (95% CI, 6.3%-9.3%) for lower-volume surgeons and 7.2% (95% CI, 6.0%-8.7%) for higher-volume surgeons.
In this cohort study that emulated 4 different target trials with data from Medicare beneficiaries undergoing pancreatectomy, mortality differences across surgical volume levels were attenuated when the interventions were well defined. The application of the hypothetical target trial framework to this specific volume-outcomes scenario revealed the complexities of this research question and the unintentional biases introduced in prior studies, which emulated poorly defined trials whose results are therefore difficult to interpret. The target trial framework may be of value to outcomes researchers asking questions that correspond to well-defined interventions for the real world.
几十年来，外科医生和医院手术量与术后患者结局的关系一直是研究的重点，这对政策具有重要意义；然而，在许多手术量-结果分析中，这种关联的描述没有考虑到明确的干预措施，这往往会引入无意识的偏见。根据这些结果采取行动可能会导致政策干预或患者推荐带来意想不到的后果。
具体说明（假设）目标试验将如何设计，以估计接受手术的患者术后死亡率与一系列外科医生和医院手术量条件之间的关联，然后使用观察数据模拟这些试验。
设计、设置和参与者：本观察性数据分析模拟了 4 个越来越复杂的假设目标试验，范围从仅随机分配参与者到外科医生手术量的定义不明确的试验到随机分配参与者到外科医生手术量、医院手术量和特定外科医生和医院的试验。这项基于人群的队列研究包括 9136 名 Medicare 受益人，他们患有胰腺恶性肿瘤的首次诊断，不需要新辅助治疗，并在 2012 年 1 月 1 日至 2016 年 9 月 30 日期间接受了胰切除术。数据分析在 2019 年 9 月 1 日至 2021 年 10 月 8 日之间进行。
外科医生和医院在前一年进行的胰切除术数量。
90 天死亡率。
分析包括 9136 名由 1358 名外科医生在 697 家医院治疗的 Medicare 受益人；中位年龄为 73.3 岁（IQR，69.1-78.1 岁），4642 人为男性（51%）。当模拟干预外科医生手术量的定义不明确的试验时，低手术量外科医生的估计 90 天死亡率为 7.9%（95%CI，6.4%-9.4%），高手术量外科医生为 5.2%（95%CI，2.7%-10.9%）。当模拟干预措施定义较好的试验时，差异有所减少：低手术量外科医生为 7.8%（95%CI，6.3%-9.3%），高手术量外科医生为 7.2%（95%CI，6.0%-8.7%）。
在这项对接受胰切除术的 Medicare 受益人的数据进行了 4 项不同目标试验模拟的队列研究中，当干预措施定义明确时，手术量水平之间的死亡率差异有所减弱。将假设的目标试验框架应用于这一特定的手术量-结果情况，揭示了该研究问题的复杂性和先前研究中引入的无意识偏见，这些研究模拟了定义不明确的试验，因此结果难以解释。目标试验框架可能对提出与现实世界中明确干预措施相对应的结果研究人员具有价值。
Zotero 插件