Cory N Criss1, Samir K Gadepalli2. 1. 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. Electronic address: cocriss@med.umich.edu. 2. 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.
Abstract
INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.