4European Tour Golf, Wentworth Drive, Surrey, UK. 5Steadman Philippon ... Medicine, University of California, Los Angeles, USA ... Tendons J 2013;3:116â7.
Infographics
Infographic: we need minimum reporting standards for biologics Iain Robert Murray,1,2 Andrew D Murray,3,4 Andrew G Geeslin,5 Ewan B Goudie,2 Timothy O White,2 Frank A Petrigliano,6 Robert F LaPrade5
Murray IR, et al. Br J Sports Med Month 2017 Vol 0 No 0
1
Infographics Biologic therapies, including platelet rich plasma (PRP) and mesenchymal stem cells, are now widely used to treat a spectrum of sports injuries without robust clinical evidence of efficacy.1 2 Physicians have a duty to use biologic therapies responsibly, using the best available research evidence to guide treatment decisions for patients. A large number of variables, including processing details, laboratory conditions and formulation composition, influence the effect of biologic therapies.3–5 Insufficient reporting of these critical variables is widespread, with only 11.5% of clinical studies investigating the use of PRP to manage musculoskeletal conditions, describing the methodology adequately.6 This precludes interpretation of the nature of biologic formulations delivered, prevents comparison between studies and makes replication by others impossible. The problem is further compounded by a lack of adequate classification systems to enable communication of preparations being used.7 The use of minimum reporting standards such as CONSORT (randomised controlled trials)8 and PRISMA (systematic reviews)9 have improved the quality of study design.10 While these existing checklists guide the reporting of universal study design features, they do not specify the inclusion of scientific variables that are specific to the study of biologics. To support a higher standard of research and encourage regulation, minimum standards of methodological reporting specific to biologics were required and have recently been developed.11 These
2
checklists (available for download at www.mibo-statement.org) can be used to assist authors in writing reports of clinical studies evaluating biologic therapies, editors and peer reviewers in reviewing manuscripts for publication and readers in critically appraising published articles. Such checklists may offer value to specialties, including sport and exercise medicine and orthopaedic surgery. 1
Scottish Centre for Regenerative Medicine, The University of Edinburgh, Edinburgh, UK 2 Department of Trauma and Orthopaedics, Royal Infirmary of Edinburgh, Edinburgh, UK 3 Centre for Sport and Exercise Medicine, University of Edinburgh, Edinburgh, UK 4 European Tour Golf, Wentworth Drive, Surrey, UK 5 Steadman Philippon Research Institute, Vail, Colorado, USA 6 Department of Orthopaedics, David Geffen School of Medicine, University of California, Los Angeles, USA Correspondence to Mr. Iain Robert Murray, Department of Trauma and Orthopaedics, University of Edinburgh, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh EH10 4SA, UK; Iain.Murray@ed.ac.uk Competing interests None declared. Provenance and peer review Not commissioned; externally peer reviewed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
To cite Murray IR, Murray AD, Geeslin AG, et al. Published Online First: [please include Day Month Year]. doi:10.1136/bjsports-2017-098122
Br J Sports Med 2017;0:1. doi:10.1136/bjsports-2017-098122
References
1 Pas HI, Reurink G, Tol JL, et al. 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;49:1197–205. 2 Laudy AB, Bakker EW, Rekers M, et al. Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. Br J Sports Med 2015;49:657–72. 3 Murray IR, LaPrade RF. Platelet-rich plasma: renewed scientific understanding must guide appropriate use. Bone Joint Res 2016;5:92–4. 4 Andia I, Maffulli N. Biological Therapies in Regenerative Sports Medicine. Sports Med 2017;47:807–28. 5 Wang D, Bakhai A, Del Buono A, et al. Sample size determination for clinical research. Muscles Ligaments Tendons J 2013;3:116–7. 6 Chahla J, Cinque ME, Piuzzi NS, et al. A Call for Standardization in Platelet-Rich Plasma Preparation Protocols and Composition Reporting: A Systematic Review of the Clinical Orthopaedic Literature. Journal of Bone and Joint Surgery (JBJS) America In Press. 7 Mautner K, Malanga GA, Smith J, et al. A call for a standard classification system for future biologic research: the rationale for new PRP nomenclature. Pm R 2015;7(4 Suppl):S53–9. 8 Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637–9. 9 Moher D, Jones A, Lepage L. CONSORT Group (Consolidated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001;285:1992–5. 10 Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006;185:263–7. 11 Murray IR, Geeslin AG, Goudie EB, et al. Minimum information for studies evaluating biologics in orthopaedics (MIBO): platelet-rich plasma and mesenchymal stem cells. J Bone Joint Surg Am 2017;99:809–19.
Murray IR, et al. Br J Sports Med Month 2017 Vol 0 No 0
