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• W2567826873 abstract "The Bone & Joint JournalVol. 99-B, No. 1 EditorialFree AccessA fusion of evidenceCrossMarkL. C. Roberts, J. O’ Dowd, A. HlavsovaL. C. RobertsPresident, Society for Back Pain Research, Associate Professor and Consultant PhysiotherapistCorrespondence should be sent to L. Roberts: E-mail Address: [email protected]Faculty of Health Sciences, University of Southampton, Highfield, Southampton, Hampshire, SO17 1BJ, UK.Search for more papers by this author, J. O’ DowdPast President, Society for Back Pain Research, Consultant Orthopaedic Spinal SurgeonHampshire Backs, Hampshire Hospitals NHS Foundation Trust, Aldermaston Road, Basingstoke, Hampshire RG24 9NA, UK.Search for more papers by this author, A. HlavsovaIndependent Researcher and PhysiotherapistHampshire Backs, Hampshire Hospitals NHS Foundation Trust, Aldermaston Road, Basingstoke, Hampshire RG24 9NA, UK.Search for more papers by this authorPublished Online:1 Jan 2017https://doi.org/10.1302/0301-620X.99B1.BJJ-2016-0488.R1AboutSectionsPDF/EPUB ToolsDownload CitationsTrack CitationsPermissionsAdd to Favourites ShareShare onFacebookTwitterLinked InRedditEmail The need to demonstrate clinical effectiveness and value in orthopaedic spinal practice is unprecedented. Previously in this journal, Professor Haddad has led a call to arms to enter more patients into prospective randomised studies, warning that Orthopaedic Surgery “undoubtedly lags behind other specialities in this area”.1 Not only will data from such trials allow the risk of benefit and harm following treatment to be quantified and variations of each within subgroups to be explored,2 but it will also provide much needed evidence on clinical and cost effectiveness for inclusion in national and international guidance, such as the National Institute for Health and Care Excellence (NICE),3 used to inform commissioning decisions and standardise the delivery of care. The strength of the randomised controlled trial (RCT) lies in its ability to minimise selection bias and to generate groups in which confounding factors, both known and unknown, are equally distributed.4 Of course, not every published RCT is reflective of level 1 evidence, due to errors in design and methodology, as well as in interpretations of data,5 and rarely considers the important non-specific effects of treatment which are so highly prized by patients as they rate their experiences. There are also inherent difficulties associated with developing a credible evidence base in those conditions that are rare, or have many variables or an unpredictable clinical course.6 Furthermore, some elements of trauma and orthopaedic practice, such as total hip arthroplasty and the surgical drainage of intra-articular infection,6 are underpinned by generations of experience and have withstood the test of time without ever formally having been tested scientifically.2Case series are often used in orthopaedic surgery as evidence of clinical effectiveness, reporting the outcomes from an individual surgeon or team, and may involve comparing outcomes from different procedures. These non-randomised series are, however, subject to bias, thereby negating any findings of superior efficacy. Case series are not included as evidence in guidelines because of the methodological limitations, and it is unclear why surgeons persist in undertaking small case series and claiming efficacy, with missed opportunities to produce level 1 evidence. This practice is hindering our specialty in achieving academic potential and should stop, especially when such comparisons readily lend themselves to a randomised trial, providing a higher level of evidence that will contribute directly to guidelines and meta-analyses. In order to discover evidence of this, we reviewed the abstracts from four major spinal conferences between 2015 and 2016 to identify the prevalence of case series compared with level 1 evidence including RCTs, systematic reviews and meta-analyses (Table I). From the 854 abstracts reviewed, the overall prevalence of case studies presented was 71% (n = 604), ranging from 67% to 75%. Case series were often erroneously described as prospective or retrospective cohort, case-control, or cross-sectional studies. The errors in the description of their design highlight the need to enhance evaluative and research methods in orthopaedic educational curricula.Table I Levels of evidence in abstracts from four orthopaedic spinal meetings 2015 to 2016Level of evidenceAbstracts1*23 4† (n, %)5Other‡Britspine 20161448 (4)36108 (75)3016Eurospine speciality meeting 2016242 (0)0116 (67)410Eurospine 201530824 (21)027223 (72)1033North American Spine Society 201537827 (21)122257 (68)0071Total85461 (46)456604 (71)81120 * The number in brackets denotes randomised controlled trials included in this total † The first figure in the level 4 column denotes case series, the second is case reports ‡ Includes: protocols; cadaveric, animal and basic science; biomechanical; qualitative studies; clinical tests; development of outcome measures; modelling, health economic and cost-utility analyses The problem of missed opportunities to provide level 1 evidence is further compounded by the increased use of registries. While they are to be commended on their attempts to link observational data with patient-reported outcome measures,7 it is important to remember that a registry is still a case series – and even though it can be vast, its size does not move it up the hierarchy of evidence. Registries clearly have a place in clinical practice, and may be helpful in identifying subgroups of patients who would benefit most from a particular form of treatment as a precursor to randomised trials. It is beyond question that resultant trials, if sufficiently powered for subgroup analyses, are required in the current healthcare climate. Having completed a piece of research, there is a professional and moral duty to disseminate findings appropriately, not only at conferences, but also in peer-reviewed publications. The quality of presentations at medical conferences is of major importance and the rates of publication following these presentations has been cited as an indicator of the extent and quality of a scientific society’s activity.8 In a review of 839 abstracts of podium and poster presentations at the Spine Society of Europe Congresses held between 2000 and 2003, only 37.8% were published in peer-reviewed journals within five years. Podium presentations had a significantly higher rate of publication than posters (OR 2.062; 95% confidence interval 1.547 to 2.749, p < 0.001).8 Furthermore, Schulte et al8 warn of the danger that the reviewing process of conferences is based on the limited abstracts which have been submitted and where data may be incomplete, and not in the full-text manuscript received for publication in a journal, thus questioning whether it is acceptable to implement these findings in practice. A key question therefore, for clinicians is: ‘should I change my practice based on what I’ve just heard/read?’As Griffin and Haddad suggest, “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.”2 This is particularly pertinent for surgeons seeking academic recognition for their clinical career, as case series are poorly viewed in the academic arena. Support is available for surgeons to engage in research to provide level 1 evidence. For example, the Research Design Services in the United Kingdom,9 funded by the National Institute for Health Research, provide free advice about the methodology and design of studies in preparation for applications for grants or fellowships. They can also assist in building a team with qualitative, methodological and health economic expertise to maximise the quality and impact of a trial. While such support may not be available in every country, it is important for clinicians to investigate what research infrastructure and support exists both locally and nationally. This may involve the use of related bodies, such as the Department of Veterans Affairs in the United States,10 which offers tool kits, training and resources that might be used to help build a strong evidence base in orthopaedic spinal practice.The public are encouraged to believe that the use of all medical and surgical interventions is supported by appropriate evidence.6 The current draft NICE guidelines for low back pain only serve to highlight how far removed this is from reality. In the 2016 draft for consultation, spinal fusion is not supported, with the statement: ‘do not offer spinal fusion for people with non-specific low back pain unless as part of a randomised controlled trial’.11 This should be a warning of the urgent need to contribute to the evidence base with level 1 evidence, and stop the practice of small-scale, comparative case series that do little to advance the field.The gauntlet has been thrown down. Can every surgeon and healthcare professional working in orthopaedic surgery rise to the challenge of contributing at least one piece of level 1 or 2 evidence and disseminate their work in a peer-reviewed academic journalduring their career, to help protect the future of spinal orthopaedic practice and ensure it gains the recognitions it deserves? References 1 Haddad FS. Fundamental questions in need of answers. Bone Joint J 2015;97-B:577. Link, ISI, Google Scholar2 Griffin XL, Haddad FS. Evidence-based decision making at the core of orthopaedic practice. Bone Joint J 2014;96-B:1000–1001. Link, ISI, Google Scholar3 No authors listed. NICE. https://www.nice.org.uk/ (date last accessed 03 November 2016). Google Scholar4 Gandhi R, Perruccio AV, Kakar S, Haddad FS. Putting the baby back in the bathwater: the interpretation of randomised trials in surgery. Bone Joint J 2015;97-B:1456–1457. Link, ISI, Google Scholar5 Stahel PF, Mauffrey C. Evidence-based medicine: a ‘hidden threat’ for patient safety and surgical innovation? Bone Joint J 2014;96-B:997–999. Link, ISI, Google Scholar6 Monsell FP. A prejudiced view. Bone Joint J 2014;96-B:1002–1004. Link, ISI, Google Scholar7 Haddad FS. What are the key drivers that change practice? Bone Joint J 2015;97-B:869–870. Link, ISI, Google Scholar8 Schulte TL, Huck K, Osada N, et al. Publication rate of abstracts presented at the Annual Congress of the Spine Society of Europe (years 2000-2003). Eur Spine J 2012;21:2105–2112. Crossref, Medline, ISI, Google Scholar9 No authors listed. National Institute for Health Research. Research Design Service. http:// http://www.rds.nihr.ac.uk/ (date last accessed 12 September 2016). Google Scholar10 No authors listed. US Department of Veterans Affairs. https://www.va.gov/opa/persona/professional_researcher.asp (date last accessed 25 November 2016). Google Scholar11 No authors listed. The National Institute for Health and Care Excellence (NICE). Guideline development & consultation for low back pain and sciatica. https://www.nice.org.uk/guidance/indevelopment/gid-cgwave0681/documents (date last accessed 12 September 2016). Google ScholarFiguresReferencesRelatedDetailsCited ByAre we the victims of our own success?F. S. Haddad30 June 2019 | The Bone & Joint Journal, Vol. 101-B, No. 7The effectiveness of anterior cervical decompression and fusion for the relief of dizziness in patients with cervical spondylosisa multicentre prospective cohort studyB. Peng, L. Yang, C. Yang, X. Pang, X. Chen, Y. Wu1 January 2018 | The Bone & Joint Journal, Vol. 100-B, No. 1In the same veinlooking forward to 2017F. S. Haddad1 January 2017 | The Bone & Joint Journal, Vol. 99-B, No. 1 Vol. 99-B, No. 1 Metrics Downloaded 74 times History Published online 1 January 2017 Published in print 1 January 2017 InformationCopyright © 2017, The British Editorial Society of Bone and Joint Surgery: All rights reservedKeywordsOrthopaedicSpinalResearchLevel of evidencePDF download" @default.
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