Level of Evidence and Industry Sponsorship Associated with Favorable Outcomes in Publications on Platelet-Rich-Plasma Therapy in Musculoskeletal Disorders^[*]

Abstract

Platelet-rich plasma is derived from centrifuging whole blood. There is increasing interest in the sports medicine and athlete community about providing endogenous growth factors directly to the injury site, using autologous blood products such as platelet-rich plasma. The aim of the present study is to evaluate the association between research financing, conflict of interests, level of evidence and author affiliation with the interpretation of results in articles published on platelet-rich plasma therapy in musculoskeletal ailments. A review of the current literature was performed. The outcome was classified as favorable or unfavorable. The declaration of conflict of interests and the type of funding was extracted from each article. The financing was classified as industry-sponsored; not industry-sponsored; or unidentifiable. The level of evidence was categorized from I to IV. Higher positive outcomes were observed in 134 studies with industry sponsorship compared with not industry-sponsored studies (odds ratio [OR]: 0.26; 95% confidence interval [95%CI]: 0.08–0.85; p < 0.05). Compared with level of evidence I, levels II and IV increase the probability of positive outcomes by 12.42 times (p < 0.01) and 10.97 times (p < 0.01) respectively. Proportionally, industry-sponsored studies are more likely to present positive results, as well as articles with a lower quality of evidence.

Keywords

platelet-rich plasma - musculoskeletal diseases - industry - conflict of interest - ethics

^* Work conducted at the Institute of Sports Medicine and Sciences Applied to Human Movement, Universidade de Caxias do Sul, RS, Brazil.

• Referências

• 1 Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol 2009; 27 (03) 158-167
• 2 Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med 2009; 37 (11) 2259-2272
• 3 Ziltener JL, Didisheim C, Borloz S. Injections of Platelet-Rich Plasma (PRP) for the treatment of sports injuries: a review. Schweiz Z Med Traumatol 2012; 60 (04) 157-160
• 4 Hamilton BH, Best TM. Platelet-enriched plasma and muscle strain injuries: challenges imposed by the burden of proof. Clin J Sport Med 2011; 21 (01) 31-36
• 5 Buchkowsky SS, Jewesson PJ. Industry sponsorship and authorship of clinical trials over 20 years. Ann Pharmacother 2004; 38 (04) 579-585
• 6 Crowninshield R. The orthopaedic profession and industry: conflict or convergence of interests. Clin Orthop Relat Res 2003; (412) 8-13
• 7 Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. Cochrane Database Syst Rev 2014; (04) CD010071
• 8 Khan SN, Mermer MJ, Myers E, Sandhu HS. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature. Am J Orthop 2008; 37 (12) E205-E212 , discussion E212
• 9 Leopold SS, Warme WJ, Fritz Braunlich E, Shott S. Association between funding source and study outcome in orthopaedic research. Clin Orthop Relat Res 2003; (415) 293-301
• 10 Oxford centre for evidence-based medicine - level of evidence. 2009 . Available at: http://www.cebm.net/index.aspx?o51025
• 11 Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. 3^rd ed. Hoboken, New Jersey: John Wiley & Sons; 2003
• 12 Griffin XL, Wallace D, Parsons N, Costa ML. Platelet rich therapies for long bone healing in adults. Cochrane Database Syst Rev 2012; (07) CD009496
• 13 Pas HI, Reurink G, Tol JL, Weir A, Winters M, Moen MH. Efficacy of rehabilitation (lengthening) exercises, platelet-rich plasma injections, and other conservative interventions in acute hamstring injuries: an updated systematic review and meta-analysis. Br J Sports Med 2015; 49 (18) 1197-1205
• 14 Amiri AR, Kanesalingam K, Cro S, Casey AT. Does source of funding and conflict of interest influence the outcome and quality of spinal research?. Spine J 2014; 14 (02) 308-314
• 15 Noordin S, Wright JG, Howard A. Relationship between declared funding support and level of evidence. J Bone Joint Surg Am 2010; 92 (07) 1647-1651
• 16 Printz JO, Lee JJ, Knesek M, Urquhart AG. Conflict of interest in the assessment of hyaluronic acid injections for osteoarthritis of the knee: an updated systematic review. J Arthroplasty 2013; 28 (8, Suppl) 30-33.e1
• 17 Bartels RH, Delye H, Boogaarts J. Financial disclosures of authors involved in spine research: an underestimated source of bias. Eur Spine J 2012; 21 (07) 1229-1233
• 18 Singh N, Bush R, Dalsing M, Shortell CK. New paradigms for physician-industry relations: overview and application for SVS members. J Vasc Surg 2011; 54 (3, Suppl) 26S-30S
• 19 Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009; 361 (15) 1466-1474
• 20 Bailey CS, Fehlings MG, Rampersaud YR, Hall H, Wai EK, Fisher CG. Industry and evidence-based medicine: Believable or conflicted? A systematic review of the surgical literature. Can J Surg 2011; 54 (05) 321-326
• 21 Pinski JM, Boakye LA, Murawski CD, Hannon CP, Ross KA, Kennedy JG. Low Level of Evidence and Methodologic Quality of Clinical Outcome Studies on Cartilage Repair of the Ankle. Arthroscopy 2016; 32 (01) 214-22.e1
• 22 Cunningham BP, Harmsen S, Kweon C, Patterson J, Waldrop R, McLaren A, McLemore R. Have levels of evidence improved the quality of orthopaedic research?. Clin Orthop Relat Res 2013; 471 (11) 3679-3686
• 23 Lynch JR, Cunningham MR, Warme WJ, Schaad DC, Wolf FM, Leopold SS. Commercially funded and United States-based research is more likely to be published; good-quality studies with negative outcomes are not. J Bone Joint Surg Am 2007; 89 (05) 1010-1018