Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study. Probst, P., Knebel, P., Grummich, K., Tenckhoff, S., Ulrich, A., Büchler, M. W., & Diener, M. K. Annals of Surgery, 264(1):87–92, 2016. doi abstract bibtex BACKGROUND: Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. METHODS: A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. RESULTS: A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P \textless 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P \textless 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P \textless 0.001). CONCLUSIONS: Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.
@article{probst_industry_2016,
title = {Industry {Bias} in {Randomized} {Controlled} {Trials} in {General} and {Abdominal} {Surgery}: {An} {Empirical} {Study}},
volume = {264},
issn = {1528-1140},
shorttitle = {Industry {Bias} in {Randomized} {Controlled} {Trials} in {General} and {Abdominal} {Surgery}},
doi = {10.1097/SLA.0000000000001372},
abstract = {BACKGROUND: Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated.
METHODS: A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95\% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed.
RESULTS: A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5\%) industry-funded trials and 19 of 50 (38.0\%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P {\textless} 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P {\textless} 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P {\textless} 0.001).
CONCLUSIONS: Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.},
language = {eng},
number = {1},
journal = {Annals of Surgery},
author = {Probst, Pascal and Knebel, Phillip and Grummich, Kathrin and Tenckhoff, Solveig and Ulrich, Alexis and Büchler, Markus W. and Diener, Markus K.},
year = {2016},
pmid = {26465782},
keywords = {8 Ignorance and funding bias, Abdomen, Biais de financement, Bias, Conflict of Interest, Digestive System Surgical Procedures, General Surgery, Humans, Industry, PRINTED (Fonds papier), Randomized Controlled Trials as Topic, United States},
pages = {87--92},
}
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{"_id":"jHtywBvhu7ADfZYZE","bibbaseid":"probst-knebel-grummich-tenckhoff-ulrich-bchler-diener-industrybiasinrandomizedcontrolledtrialsingeneralandabdominalsurgeryanempiricalstudy-2016","authorIDs":[],"author_short":["Probst, P.","Knebel, P.","Grummich, K.","Tenckhoff, S.","Ulrich, A.","Büchler, M. W.","Diener, M. K."],"bibdata":{"bibtype":"article","type":"article","title":"Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study","volume":"264","issn":"1528-1140","shorttitle":"Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery","doi":"10.1097/SLA.0000000000001372","abstract":"BACKGROUND: Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. METHODS: A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. RESULTS: A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P \\textless 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P \\textless 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P \\textless 0.001). CONCLUSIONS: Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.","language":"eng","number":"1","journal":"Annals of Surgery","author":[{"propositions":[],"lastnames":["Probst"],"firstnames":["Pascal"],"suffixes":[]},{"propositions":[],"lastnames":["Knebel"],"firstnames":["Phillip"],"suffixes":[]},{"propositions":[],"lastnames":["Grummich"],"firstnames":["Kathrin"],"suffixes":[]},{"propositions":[],"lastnames":["Tenckhoff"],"firstnames":["Solveig"],"suffixes":[]},{"propositions":[],"lastnames":["Ulrich"],"firstnames":["Alexis"],"suffixes":[]},{"propositions":[],"lastnames":["Büchler"],"firstnames":["Markus","W."],"suffixes":[]},{"propositions":[],"lastnames":["Diener"],"firstnames":["Markus","K."],"suffixes":[]}],"year":"2016","pmid":"26465782","keywords":"8 Ignorance and funding bias, Abdomen, Biais de financement, Bias, Conflict of Interest, Digestive System Surgical Procedures, General Surgery, Humans, Industry, PRINTED (Fonds papier), Randomized Controlled Trials as Topic, United States","pages":"87–92","bibtex":"@article{probst_industry_2016,\n\ttitle = {Industry {Bias} in {Randomized} {Controlled} {Trials} in {General} and {Abdominal} {Surgery}: {An} {Empirical} {Study}},\n\tvolume = {264},\n\tissn = {1528-1140},\n\tshorttitle = {Industry {Bias} in {Randomized} {Controlled} {Trials} in {General} and {Abdominal} {Surgery}},\n\tdoi = {10.1097/SLA.0000000000001372},\n\tabstract = {BACKGROUND: Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated.\nMETHODS: A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95\\% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed.\nRESULTS: A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5\\%) industry-funded trials and 19 of 50 (38.0\\%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P {\\textless} 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P {\\textless} 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P {\\textless} 0.001).\nCONCLUSIONS: Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.},\n\tlanguage = {eng},\n\tnumber = {1},\n\tjournal = {Annals of Surgery},\n\tauthor = {Probst, Pascal and Knebel, Phillip and Grummich, Kathrin and Tenckhoff, Solveig and Ulrich, Alexis and Büchler, Markus W. and Diener, Markus K.},\n\tyear = {2016},\n\tpmid = {26465782},\n\tkeywords = {8 Ignorance and funding bias, Abdomen, Biais de financement, Bias, Conflict of Interest, Digestive System Surgical Procedures, General Surgery, Humans, Industry, PRINTED (Fonds papier), Randomized Controlled Trials as Topic, United States},\n\tpages = {87--92},\n}\n\n","author_short":["Probst, P.","Knebel, P.","Grummich, K.","Tenckhoff, S.","Ulrich, A.","Büchler, M. W.","Diener, M. K."],"key":"probst_industry_2016","id":"probst_industry_2016","bibbaseid":"probst-knebel-grummich-tenckhoff-ulrich-bchler-diener-industrybiasinrandomizedcontrolledtrialsingeneralandabdominalsurgeryanempiricalstudy-2016","role":"author","urls":{},"keyword":["8 Ignorance and funding bias","Abdomen","Biais de financement","Bias","Conflict of Interest","Digestive System Surgical Procedures","General Surgery","Humans","Industry","PRINTED (Fonds papier)","Randomized Controlled Trials as Topic","United States"],"metadata":{"authorlinks":{}},"downloads":0},"bibtype":"article","biburl":"http://bibbase.org/zotero-group/science_et_ignorance/1340424","creationDate":"2019-05-09T14:50:13.396Z","downloads":0,"keywords":["8 ignorance and funding bias","abdomen","biais de financement","bias","conflict of interest","digestive system surgical procedures","general surgery","humans","industry","printed (fonds papier)","randomized controlled trials as topic","united states"],"search_terms":["industry","bias","randomized","controlled","trials","general","abdominal","surgery","empirical","study","probst","knebel","grummich","tenckhoff","ulrich","büchler","diener"],"title":"Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study","year":2016,"dataSources":["zX4acseCDM6D58AW7","NTvuMntpta5z9CAbT"]}