Section of Pediatric Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA; Department of General Surgery, Michigan Medicine, Ann Arbor, MI, USA.
Section of Pediatric Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA; Department of General Surgery, Michigan Medicine, Ann Arbor, MI, USA.
Am J Surg. 2018 Jul;216(1):84-87. doi: 10.1016/j.amjsurg.2017.08.017. Epub 2017 Aug 26.
The integrity of the medical literature about robotic surgery remains unclear despite wide-spread adoption. We sought to determine if payment from Intuitive Surgical Incorporated (ISI) affected quality of the research produced by surgeons.
Publicly available financial data from the CMS website regarding the top-20 earners from ISI for 2015 was gathered. Studies conducted by these surgeons were identified using PubMed. Inclusion criteria consisted of publications about the da Vinci robot on patient outcomes. The primary outcome of our study was if the study conclusion was positive/equivocal/negative towards the robot. Secondary outcomes included authorship, sponsorship, study controls, and disclosure.
The top earners received $3,296,844 in 2015, with a median of $141,959. Sub-specialties included general surgery (55%), colorectal (20%), thoracic (15%), and obstetrics/gynecology (10%). Of the 37 studies, there was 1 RCT, with observational studies comprising the rest. The majority of the studies (n = 16, 43%) had no control population, with 11 (30%) comparing to same institution/surgeon, Though ISI sponsored only 6 (16%) studies, all with positive conclusions, 27 (73%) studies had positive conclusions for robot use, 9 (24%) equivocal, and only 1 (3%) negative. Overall, 13 earners had lead authorship and 11 senior.
This initial pilot study highlights a potential bias as current literature published by benefactors demonstrates low quality and highly positive conclusions towards approval of the robot. This substantiates the need for a large, systematic review of the potential influence of sponsoring surgeons on medical literature.
尽管机器人手术已广泛应用，但医学文献的完整性仍不清楚。我们旨在确定直觉外科公司（Intuitive Surgical Incorporated，简称 ISI）的付款是否会影响外科医生研究的质量。
从 CMS 网站上获取了有关 2015 年 ISI 收入最高的前 20 名外科医生的公开财务数据。使用 PubMed 确定这些外科医生进行的研究。纳入标准包括关于达芬奇机器人在患者结果方面的研究。本研究的主要结果是研究结论对机器人的积极/不确定/消极。次要结果包括作者身份、赞助、研究控制和披露。
收入最高的医生在 2015 年获得了 329.6844 美元，中位数为 141959 美元。亚专业包括普通外科（55%）、结直肠外科（20%）、胸外科（15%）和妇产科（10%）。在 37 项研究中，有 1 项 RCT，其余均为观察性研究。大多数研究（n=16，43%）没有对照人群，其中 11 项（30%）与同一机构/外科医生比较，尽管 ISI 仅赞助了 6 项（16%）研究，但所有研究的结论均为积极，27 项（73%）研究的机器人使用结论为积极，9 项（24%）为不确定，只有 1 项（3%）为消极。总的来说，有 13 名医生为主要作者，11 名为资深作者。
本初步试点研究突出了一种潜在的偏见，即当前由受惠者发表的文献质量低，对机器人的批准结论高度积极。这证实了需要对赞助外科医生对医学文献的潜在影响进行大规模、系统的审查。
