Joseph Lopez1, Erin Prifogle, Theodore T Nyame, Jacqueline Milton, James W May. 1. Boston and Waltham, Mass. From Harvard Medical School; the Division of Clinical Studies, TEI Biosciences; the Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital; and the Department of Biostatistics, Boston University School of Public Health.
Abstract
BACKGROUND: Although conflicts of interest in biomedical research have received significant attention, the impact of conflicts of interest on surgical outcomes has not been fully explored. METHODS: A systematic electronic search of the literature was performed for studies that evaluated surgical outcomes in acellular dermal matrix and non-acellular dermal matrix implant-based breast reconstruction. Surgical complications, including infection, seroma, hematoma, necrosis, and explantation, were used as outcome metrics and extracted from studies. Surgical outcomes were then pooled and compared between studies that disclosed conflicts of interest and those that did not disclose conflicts of interest. RESULTS: A total of 776 abstracts were identified, of which only 35 fulfilled the authors' inclusion criteria. Conflicts of interest were reported in 14 of these abstracts (40 percent). The pooled data from studies that reported no conflicts of interest and studies that reported conflicts of interest included a total of 8241 and 5384 breasts and 2852 and 1864 patients, respectively. Considered collectively, surgical complications were less common in studies that reported a conflict of interest than in studies that reported no conflicts of interest. When surgical outcome data were further stratified by acellular dermal matrix use, surgical complications were less common in studies with conflicts of interest when acellular dermal matrix was used. However, when acellular dermal matrix was not used, surgical complications were similar between authors that reported a conflict of interest and those that did not report a conflict of interest. CONCLUSIONS: Self-reported conflicts of interest are common in implant-based breast reconstruction research. Studies authored by groups with conflicts of interest are significantly associated with reporting lower surgical complications and therefore describing positive research findings, especially when industry-marketed products are being used in the study. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
BACKGROUND: Although conflicts of interest in biomedical research have received significant attention, the impact of conflicts of interest on surgical outcomes has not been fully explored. METHODS: A systematic electronic search of the literature was performed for studies that evaluated surgical outcomes in acellular dermal matrix and non-acellular dermal matrix implant-based breast reconstruction. Surgical complications, including infection, seroma, hematoma, necrosis, and explantation, were used as outcome metrics and extracted from studies. Surgical outcomes were then pooled and compared between studies that disclosed conflicts of interest and those that did not disclose conflicts of interest. RESULTS: A total of 776 abstracts were identified, of which only 35 fulfilled the authors' inclusion criteria. Conflicts of interest were reported in 14 of these abstracts (40 percent). The pooled data from studies that reported no conflicts of interest and studies that reported conflicts of interest included a total of 8241 and 5384 breasts and 2852 and 1864 patients, respectively. Considered collectively, surgical complications were less common in studies that reported a conflict of interest than in studies that reported no conflicts of interest. When surgical outcome data were further stratified by acellular dermal matrix use, surgical complications were less common in studies with conflicts of interest when acellular dermal matrix was used. However, when acellular dermal matrix was not used, surgical complications were similar between authors that reported a conflict of interest and those that did not report a conflict of interest. CONCLUSIONS: Self-reported conflicts of interest are common in implant-based breast reconstruction research. Studies authored by groups with conflicts of interest are significantly associated with reporting lower surgical complications and therefore describing positive research findings, especially when industry-marketed products are being used in the study. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
Authors: Paula R Gravina; Rowland W Pettit; Matthew J Davis; Sebastian J Winocour; Jesse C Selber Journal: Semin Plast Surg Date: 2019-10-17 Impact factor: 2.314
Authors: Rizwan Ahmed; Joseph Lopez; Sunjae Bae; Allan B Massie; Eric K Chow; Karan Chopra; Babak J Orandi; Bonnie E Lonze; James W May; Justin M Sacks; Dorry L Segev Journal: Ann Plast Surg Date: 2017-03 Impact factor: 1.539