Medical and surgical research has always had a long-standing relationship with industry-based funding from sources, such as drug and device companies. Concerns exist surrounding the association between funding sources, outcome from studies and publication bias. Studies demonstrating increased odds ratios associated with positive results in industry sponsored studies across medicine have stimulated Cochrane reviews, literature reviews and other articles to examine this relationship further. In spine surgery in particular, studies with positive results have an odds ratio of 3.3 of being published. This article discusses the biases associated with industry sponsorship, possible ways to reduce such biases and ways to improve transparency in research relationships. This article explores the types of bias that can be encountered at different stages of research including previous trials in spine surgery. The means of improving transparency including the Physician Payment Sunshine Act of 2010 and International Committee of Medical Journal Editors (ICJME) accreditation are discussed. We recognize that physicians undertaking industry sponsored research should be protected and not be liable to perverse incentives. We conclude that mitigating bias in industry sponsored research is a multistep process and needs a multifaceted approach. The main beneficiary of research should be patients and as such a collective effort from medical professionals, health care institutions, journals and industry should approach research, and publications with that in mind.
References
Shah R, Albert T, Bruegel-Sanchez V, et al. Industry support and correlation to study outcome for papers published in spine. Spine. 2005;30:1099–1104.
Roach JW, Skaggs DL, Sponseller PD, et al. Is research presented at the scoliosis research society annual meeting influenced by industry funding. Spine. 2008;33:2208–2212.
Amiri AR, Kanesalingam K, Cro S, et al. Does source of funding and conflict of interest influence the outcome and quality of spinal research. Spine. 2014;14:308–314.
Lundh A, Lexchin J, Mintzes B, et al. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017;2:4–144.
Pannucci JC, Wilkins EG. Identifying and avoiding bias in research. Plast Reconstr Surg. 2010;126:619–625.
Nichol AD, Bailey M, Cooper DJ. Challenging issues in randomised controlled trials. Injury. 2010;41:2–4.
Hiratzka J, Rastegar F, Contag A, et al. Adverse event recording and reporting in clinical trials comparing lumbar disk replacement with lumbar fusion: a systematic review. Global Spine J. 2015;5:486–495.
Godwin M, Ruhland L, Casson I, et al. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Method. 2003;3:4–7.
Higgins J, Savovic J, Page MJ, et al. Revised Cochrane risk-of-bias tool for randomized trials (RoB 2). Cochrane. 2018;10:1–69.
Higgins J, Altman D, Gotzsche P, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomized trials. BMJ. 2011;343:1–9.
Sterne J, Hernan M, Reeves B, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:1–7.
Rana JS, Mannam A, Donnell-Fink L, et al. Longevity of the placebo effect in the therapeutic angiogenesis and laser revascularization trials in patients with coronary heart disease. Am J Cardiol. 2005;95:1456–1459.
McRae C, Cherin E, Yamazaki TG, et al. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004;61:412–420.
Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. New Engl J Med. 2009;361:570–579.
Moseley JB, O’Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New Engl J Med. 2002;347:82–87.
Shikora SA, Bergenstal R, Bessler M, et al. Implantable gastric stimulation for the treatment of clinically severe obesity. Surg Obes Relat Dis. 2009;5:33–37.
Rosenthal R. The Pygmalion effect and its mediating mechanisms. In Improving academic achievement. Academic Press; 2002:25–36.
Auerbach JD, McGowan KB, Halevi M. Mitigating adverse event reporting bias in spine surgery. J Bone Joint Surg. 2013;95 (A):1450–1457.
Dickersin K, Min YI. Publication bias: the problem that won’t go away. Ann N Y Acad Sci. 1993;703:135–146.
Chan AW, Pello A, Kitchen J. Association of trial registration with reporting of primary outcomes in protocols and publications. JAMA. 2017;318:1709–1711.
Leopold S, Swiontkowski M, Haddad F. Importance of prospective registration of randomised clinical trials. J Bone Joint Surg. 2016;98:1947–1948.
Clinical Trials. ICMJE recommendations defining the role of authors and contributors. 2018. Available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html . Accessed December 28, 2018.
Brand A. Beyond authorship: an introduction to the credit taxonomy. Nature. 2014;508:312–313.
Gasparyan A, Akazhanov N, Voronov A, et al. Systematic and open identification of researchers and authors: focus on open researcher and contributor ID. J Korean Med Sci. 2014;29:1453–1456.
Okike K, Kocher M, Mehlman C, et al. Publication bias in orthopaedic research: an analysis of scientific factors associated with publication in The Journal of Bone and Joint Surgery (American Volume). J Bone Joint Surg Am. 2008;90:595–600.
CMS. Open Payments Data. The facts about open payments. 2018. Available at: https://openpaymentsdata.cms.gov/summary . Accesed December 6, 2018.
Young A, Arnhart K. A census of actively licensed physicians in the United States, 2016. J Med Regul. 2017;103:7–19.
McDermott E, McDermott W. Snapshot of sunshine rules in EU countries for the pharmaceutical industry. 2014. Available at: https://www.mwe.com/insights/snapshot-of-sunshine-rules-in-eu-countries-for-the/ . Accessed December 6, 2018.
Fabbri A, Santos A, Mezinska S, et al. Sunshine policies and murky shadows in Europe: disclosure of pharmaceutical industry payments to health professionals in nine European countries. Int J Health Policy Manag. 2018;7:504–509.
Nathan DG, Weatherall DJ. Academic freedom in clinical research. N Engl J Med. 2002;347:1368–1370.
Bartels R, Delye H, Boogaarts J. Financial disclosures of authors involved in spine research: an underestimated source of bias. Eur Spine J. 2012;21:1229–1233.
