 EDITORIAL

Evidence-based decision making at the core of orthopaedic practice

X. L. Griffin, F. S. Haddad From University College London Hospitals, London, United Kingdom

 X. L. Griffin, MA, PhD, FRCS, NIHR Clinical Lecturer Warwick University, Clinical Trials Unit, Gibbet Hill Road, Coventry, UK.  F. S. Haddad, BSc, MD, FRCS (Orth), Professor of Orthopaedic Surgery, University College London Hospitals, 235 Euston Road, London, NW1 2BU, UK. Correspondence should be sent to Professor F. S. Haddad; e-mail: [email protected] ©2014 The British Editorial Society of Bone & Joint Surgery doi:10.1302/0301-620X.96B8. 34614 $2.00 Bone Joint J 2014;96-B:1000–1.

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We have all been asked: “What is the evidence to support your decision?” on ward rounds, in clinic and in daily trauma meetings and have experienced exhortations from colleagues in support of evidence-based medicine (EBM) and practice. It is now almost unthinkable that such practice is anything but beneficial, and research and audit are important components of our daily working lives. If this is true then what benefit can we and our patients expect from these efforts? At BJJ, we strive to strike a balance between encouraging the highest level of rigour in research,1-6 whilst accepting that some elements of trauma and orthopaedic practice are underpinned by generations of experience and have withstood the test of time without ever formally being tested in a scientific way.7,8 Our aim is to publish the most appropriate studies in order to answer important research questions - we anticipate that this will include the full range of study designs. Orthopaedic surgeons have a long tradition of audit and research; it did not begin with the proponents of the gold-plated, double blind, placebo controlled trial. This tradition is perhaps best exemplified by Professor Sir John Charnley’s close surveillance of his hip implants9 and has current expression in the many joint registries maintained around the world. We have always been interested in exploring the effectiveness of our interventions - the new paradigm of EBM is, in that sense, not new. Where treatments have a clear benefit, that is the treatment effect is large, expensive randomised trials are not required or even desirable - no-one would seriously suggest a trial exploring the place of total hip replacement in the treatment of osteoarthrosis. ‘Traditional’ case series are much more appropriate. But we should realise that whilst valuable, the reports of an individual surgeon’s experience are not the best evidence to assess effectiveness when there is real uncertainty between the benefits of different forms of treatment. Non-randomised studies are vulnerable to bias, or systematic

error, where aspects of the study design have an important influence on the size and direction of the treatment effect, and will probably lead to a substantial overestimation of how effective a treatment may be. Traditional statistical techniques which describe the precision of treatment effect estimates are not applicable in non-randomised study designs.10 Therefore, it is difficult to determine how data from such studies can be applied to our patients. The arguments for and against EBM are lengthy and have been well rehearsed11 since the term was first used in 1991.12 Much of the criticism is historical and surrounds the proposition that EBM is a new paradigm or model on which to base surgical practice. The implication being, for example, that EBM might be able to replace an anatomical or pathophysiological understanding of orthopaedic conditions. Such a narrow definition is unhelpful and misleading. Many authors have suggested more appropriate definitions focused on the proper criticism and synthesis of evidence and its appropriate application to help guide clinical decision making.13 It is worth, however, considering some of the common criticisms which are most pertinent to surgical practice. Firstly, that evidence concerning ‘average’ effectiveness of complex surgical interventions in the ‘average’ patient does not help when confronted with a specific patient in a specific institution. Secondly, the incorporation of research findings into guidelines impinges upon the autonomy of the surgeon/ patient relationship and implies a surgeon’s personal experience is irrelevant. It is certainly true that there are many challenges associated with the interpretation and application of evidence in surgical practice. However, high quality research in populations of patients can be usefully interpreted to explore variations in effectiveness within different subgroups. Exploration of variation in the effectiveness of a treatment related to surgeon or institution-specific differences as well as important patient characteristics can and should THE BONE & JOINT JOURNAL

EVIDENCE-BASED DECISION MAKING AT THE CORE OF ORTHOPAEDIC PRACTICE

be performed. The risk of treatment for each individual patient is something which all surgeons assess ‘at the end of the bed’ and is a crucial component of the risk–benefit tradeoffs for our patients.14 Data from randomised trials allows us to quantify the risk of benefit and harm following an intervention and explore variations of each within subgroups. These analyses may be complex and time consuming but are helpful in tailoring interventions to individuals. Such formal analyses are often performed by established organisations, such as the Cochrane Collaboration15 or The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group.16 Since it is not possible that each of us can keep up-to-date with the pace of research across the entire discipline of orthopaedic surgery, nor be an expert epidemiologist or statistician, we must be prepared to place some trust in such institutions. Clearly, this trust should be fostered through the highest standards of academic rigour, explicit reporting, clear expression of the purpose of the work and political independence. Given these conditions, the output from these organisations can only be helpful in guiding treatment. In addition to the methodological advantages of high quality research, are the indirect benefits associated with a research-orientated institution. Many factors may be important here - infrastructure improvements funded by research income, systems for the careful follow-up of patients, and the fostering of a critical mindset amongst surgeons and allied health professionals; in summary, the kind of environment which can foster the surgeon–scientist. Whilst it is difficult to determine the relative impact of each of these components, it may be true that patients have better outcomes when treated in institutions which also undertake research.17 High-quality research can help answer the questions with which our community of surgeons is wrestling. The role of the surgeon will remain - the critical analysis, explanation and application of these data to each individual patient to inform their decision making. Surely then we must be forward-leaning; rejection of the scientific method is in no-one’s interest, and will ultimately be self-defeating.

VOL. 96-B, No. 8, AUGUST 2014

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It is our duty to be part of the proper development, conduct, review and application of high-quality research in order to lead our field.

References 1. Hamilton TW, Hutchings L, Alsousou J, et al. The treatment of stable paediatric forearm fractures using a cast that may be removed at home: comparison with traditional management in a randomised controlled trial. Bone Joint J 2013;95-B:1714– 1720. 2. D’Agostino P, Barbier O. An investigation of the effect of AlloMatrix bone graft in distal radial fracture: a prospective randomised controlled clinical trial. Bone Joint J 2013;95-B:1514–1520. 3. Kolk A, Yang KG, Tamminga R, van der Hoeven H. Radial extracorporeal shockwave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial. Bone Joint J 2013;95B:1521–1526. 4. Maripuri SN, Gallacher PD, Bridgens J, Kuiper JH, Kiely NT. Ponseti casting for club foot - above- or below-knee?: A prospective randomised clinical trial. Bone Joint J 2013;95-B:1570–1574. 5. Faber FW, van Kampen PM, Bloembergen MW. Long-term results of the Hohmann and Lapidus procedure for the correction of hallux valgus: a prospective, randomised trial with eight- to 11-year follow-up involving 101 feet. Bone Joint J 2013;95-B:1222–1226. 6. Inglis M, McClelland B, Sutherland LM, Cundy PJ. Synthetic versus plaster of Paris casts in the treatment of fractures of the forearm in children: a randomised trial of clinical outcomes and patient satisfaction. Bone Joint J 2013;95-B:1285–1289. 7. Monsell F. A prejudiced view. Bone Joint J 2014;96-B;1002–1004. 8. Stahel PF, Mauffrey C. Evidence-based medicine: a ‘hidden threat’ for patient safety and surgical innovation? Bone Joint J 2014;96-B;997–999 9. Charnley J. The long-term results of low-friction arthroplasty of the hip performed as a primary intervention. J Bone Joint Surg [Br] 1972;54-B:61–76. 10. Deeks JJ, Dinnes J, D'Amico R, et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003;7:1–173. 11. Cohen AM, Stavri PZ, Hersh WR. A categorization and analysis of the criticisms of Evidence-Based Medicine. Int J Med Inform 2004;73:35–43. 12. Guyatt GH Evidence based medicine, ACP J Club 1991;114:A16 [editorial]. 13. Haynes RB, Devereaux PJ, Guyatt GH. Physicians' and patients' choices in evidence based practice. BMJ 2002;324:1350. 14. No authors listed. National Health and Medical Research Council: A guide to the development, evaluation and implementation of clinical practice guidelines, 1999. http://www.health.qld.gov.au/cpcre/pdf/nhmrc clinprgde.pdf (date last accessed 09 June 2014). 15. No authors listed. Cochrane Collaboration. http://www.cochrane.org/ (date last accessed 12 June 2014). 16. No authors listed. The Grading of Recommendations, Assessment, Development and Evaluation working group. http://www.gradeworkinggroup.org/ (date last accessed 12 June 2014). 17. Clarke M, Loudon K. Effects on patients of their healthcare practitioner's or institution's participation in clinical trials: a systematic review. Trials 2011;12:16.

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