Breaking through the glass ceiling effect of high-grade clinical evidence creation in orthopaedics & trauma
DOI:
https://doi.org/10.1016/j.rccot.2022.10.003Keywords:
Randomized Controlled Trial, Clinical Trial Protocol, Epidemiologic Research Design, Cohort Studies, StatisticsAbstract
Introduction: Randomization protocols in clinical studies of common orthopedic problems and traumatic injuries are challenging to orchestrate. The lack of high-grade clinical evidence from prospective randomized, double-blinded study design is often cited as a primary reason for rejecting proposed therapy advances in orthopedic surgery.
Materials and Methods: This position paper summarizes the clinical trial limitations in surgical subspecialties. We present a consensus statement on how practicing orthopedic surgeon can produce high-quality clinical evidence to affect changes in practice protocols.
Results: Our literature review revealed that classifications of level of evidence reporting varies between surgical subspecialties. Research in orthopedic- and musculoskeletal trauma care is primarily directed at the diagnosis, preferred treatment, and economic decision analysis, whereas other prognosis-based classifications are preferred in other areas such as plastic surgery. In orthopedics, controlled double-blinded randomization is rare and often unpractical or unethical for a placebo control purpose where patients may be harmed. Crossing over between study groups randomized surgical trials is common. Other obstacles in surgical trials range from lack of organizational and financial support, institutional review or ethics board approval, and registration
requirements for clinical trials to insufficient time left outside an already busy clinical schedule to dedicate to this laborious uncompensated task.
Conclusion: Orthopedic surgery is as an experience- and skill-based subspecialty. Many innovations start with entrepreneur surgeons as reporting of opinions or retrospective cohort studies many of which suffer from bias. Prospective observational cohort studies with consistent results may offer higher-grade clinical evidence than poorly executed randomized trials.
Downloads
References
Safiri S, Kolahi AA, Smith E, et al. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020;79:819-28. https://doi.org/10.1136/annrheumdis-2019-216515
Coury HJ. Time trends in ergonomic intervention research for improved musculoskeletal health and comfort in Latin America. Appl Ergon. 2005;36:249-52. https://doi.org/10.1016/j.apergo.2004.10.010
Rockhold FW. Industry perspectives on ICH guidelines. Stat Med. 2002;21:2949-57. https://doi.org/10.1002/sim.1299
Malik AY, Foster C. The revised Declaration of Helsinki: cosmetic or real change? J R Soc Med. 2016;109:184-9. https://doi.org/10.1177/0141076816643332
Shrestha BM. The Declaration of Helsinki in relation to medical research: historical and current perspectives. J Nepal Health Res Counc. 2012;10:254-7.
Riis P. Thirty years of bioethics: the Helsinki Declaration 1964-2003. New Rev Bioeth. 2003;1:15-25. https://doi.org/10.1080/1740028032000131396
Declaration of Helsinki. Recommendations guiding doctors in clinical research. Adopted by the World Medical Association in 1964. Wis Med J 1967;66:25-6.
Murano G. International Conference on Harmonization-critical discussion of the biotech'Specifications' document. Curr Opin Biotechnol. 2000;11:303-8. https://doi.org/10.1016/S0958-1669(00)00100-2
The periodic health examination. Canadian Task Force on the Periodic Health Examination. Can Med Assoc J 1979;121:1193-254.
Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest. 1989;95:2s-4s. https://doi.org/10.1378/chest.95.2_Supplement.2S
Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011;128:305-10. https://doi.org/10.1097/PRS.0b013e318219c171
Ariyan S, Martin J, Lal A, et al. Antibiotic prophylaxis for preventing surgical-site infection in plastic surgery: an evidence-based consensus conference statement from the American Association of Plastic Surgeons. Plast Reconstr Surg. 2015;135:1723-39. https://doi.org/10.1097/PRS.0000000000001265
Sullivan D, Chung KC, Eaves FF3rd, et al. The Level of Evidence Pyramid: Indicating Levels of Evidence in Plastic and Reconstructive Surgery Articles. Plast Reconstr Surg. 2021;148:68s-71s. https://doi.org/10.1097/01.prs.0000794868.07051.b4
Perdikis G, Dillingham C, Boukovalas S, et al. American Society of Plastic Surgeons Evidence-Based Clinical Practice Guideline Revision: Reduction Mammaplasty. Plast Reconstr Surg. 2022;149:392e-409e. https://doi.org/10.1097/PRS.0000000000008860
Centre for Evidence Based Medicine (CEBM). 2013.
Solheim O. Randomized controlled trials in surgery and the glass ceiling effect. Acta Neurochir (Wien). 2019;161:623-5. https://doi.org/10.1007/s00701-019-03850-3
Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. Jama. 2006;296:2441-50. https://doi.org/10.1001/jama.296.20.2441
Abdu WA, Sacks OA, Tosteson ANA, et al. Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2018;43:1619-30. https://doi.org/10.1097/BRS.0000000000002682
From the American Society of Plastic Surgeons. Evidence-based clinical practice guidelines.
Watters W, 3rd, Rethman MP, Hanson NB, et al. Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures. J Am Acad Orthop Surg. 2013;21:180-9. https://doi.org/10.5435/JAAOS-21-03-180
Meiyappan KP, Cote MP, Bozic KJ, et al. Adherence to the American Academy of Orthopaedic Surgeons Clinical Practice Guidelines for Nonoperative Management of Knee Osteoarthritis. J Arthroplasty. 2020;35:347-52. https://doi.org/10.1016/j.arth.2019.08.051
Bono CM, Watters WC3rd, Heggeness MH, et al. An evidencebased clinical guideline for the use of antithrombotic therapies in spine surgery. Spine J. 2009;9:1046-51. https://doi.org/10.1016/j.spinee.2009.09.005
Bono CM, Ghiselli G, Gilbert TJ, et al. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011;11:64-72. https://doi.org/10.1016/j.spinee.2010.10.023
Kreiner DS, Shaffer WO, Baisden JL, et al. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update). Spine J. 2013;13:734-43. https://doi.org/10.1016/j.spinee.2012.11.059
Shaffer WO, Baisden JL, Fernand R, et al. An evidence-based clinical guideline for antibiotic prophylaxis in spine surgery. Spine J. 2013;13:1387-92. https://doi.org/10.1016/j.spinee.2013.06.030
Kaiser MG, Eck JC, Groff MW, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: introduction and methodology. J Neurosurg Spine. 2014;21:2-6. https://doi.org/10.3171/2014.4.SPINE14257
Kreiner DS, Hwang SW, Easa JE, et al. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014;14:180-91. https://doi.org/10.1016/j.spinee.2013.08.003
Kreiner DS, Baisden J, Mazanec DJ, et al. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis. Spine J. 2016;16:1478-85. https://doi.org/10.1016/j.spinee.2016.08.034
Matz PG, Meagher RJ, Lamer T, et al. Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis. Spine J. 2016;16:439-48. https://doi.org/10.1016/j.spinee.2015.11.055
Tan SY, Linskey K. Christiaan Barnard (1922-2001): First heart transplant surgeon. Singapore Med J. 2019;60:495-6. https://doi.org/10.11622/smedj.2019127
Gawande A. Two Hundred Years of Surgery. New England Journal of Medicine. 2012;366:1716-23. https://doi.org/10.1056/NEJMra1202392
Moseley JB, O'Malley K, Petersen NJ, et al. A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee. New England Journal of Medicine. 2002;347:81-8. https://doi.org/10.1056/NEJMoa013259
Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic Partial Meniscectomy versus Sham Surgery for a Degenerative Meniscal Tear. New England Journal of Medicine. 2013;369:2515-24. https://doi.org/10.1056/NEJMoa1305189
Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361:557-68. https://doi.org/10.1056/NEJMoa0900429
Paavola M, Malmivaara A, Taimela S, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ. 2018;362:k2860. https://doi.org/10.1136/bmj.k2860
Probst P, Grummich K, Harnoss JC, et al. Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis. Medicine. 2016;95:e3516. https://doi.org/10.1097/MD.0000000000003516
Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358:794-810. https://doi.org/10.1056/NEJMoa0707136
Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008;33:2789-800. https://doi.org/10.1097/BRS.0b013e31818ed8f4
Pearson AM, Blood EA, Frymoyer JW, et al. SPORT lumbar intervertebral disk herniation and back pain: does treatment, location, or morphology matter? Spine (Phila Pa 1976). 2008;33:428-35. https://doi.org/10.1097/BRS.0b013e31816469de
Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007;356:2257-70. https://doi.org/10.1056/NEJMoa070302
Martin E, Muskens IS, Senders JT, et al. Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review. Acta Neurochirurgica. 2019;161:627-34. https://doi.org/10.1007/s00701-019-03849-w
Hempel S, Miles SMJNV, et al. Empirical Evidence of Associations Between Trial Quality and Effect Size [Internet]. Agency for Healthcare Research and Quality (US); 2011 Jun. [Table]. Jadad Scale.]. 2022. Available at: https://www.ncbi.nlm.nih.gov/books/NBK56923/table/appendixes.app6.t1/.
Augestad KM, Berntsen G, Lassen K, et al. Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support. J Am Med Inform Assoc. 2012;19:13-21. https://doi.org/10.1136/amiajnl-2011-000411
Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Jama. 2001;285:1987-91. https://doi.org/10.1001/jama.285.15.1987
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191-4. https://doi.org/10.1016/S0140-6736(00)04337-3
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-62. https://doi.org/10.7326/0003-4819-134-8-200104170-00011
Lewandrowski KU, de Carvalho PST, Calderaro AL, et al. Outcomes with transforaminal endoscopic versus percutaneous laser decompression for contained lumbar herniated disc: a survival analysis of treatment benefit. J Spine Surg. 2020;6. S99-S84. https://doi.org/10.21037/jss.2019.09.13
Lewandrowski KU, Dowling A, de Carvalho P, et al. Indication And Contraindication Of Endoscopic Transforaminal Lumbar Decompression. World Neurosurg. 2020. https://doi.org/10.1016/j.wneu.2020.03.076
Lewandrowski KU, Yeung A. Meaningful outcome research to validate endoscopic treatment of common lumbar pain generators with durability analysis. J Spine Surg. 2020;6:S6-13. https://doi.org/10.21037/jss.2019.09.07
Lewandrowski KU, Tieber F, Hellinger S, et al. Durability of Endoscopes Used During Routine Lumbar Endoscopy: An Analysis of Use Patterns, Common Failure Modes. Impact on Patient Care, and Contingency Plans. Int J Spine Surg. 2021;15:1147-60. https://doi.org/10.14444/8146
Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Jama. 1995;273:408-12. https://doi.org/10.1001/jama.1995.03520290060030
Reed CC, Wolf WA, Cotton CC, et al. A visual analogue scale and a Likert scale are simple and responsive tools for assessing dysphagia in eosinophilic oesophagitis. Aliment Pharmacol Ther. 2017;45:1443-8. https://doi.org/10.1111/apt.14061
Fairbank J. Use of Oswestry Disability Index (ODI). Spine (Phila Pa 1976). 1995;20:1535-7. https://doi.org/10.1097/00007632-199507000-00020
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000;25:2940-52, discussion 52. https://doi.org/10.1097/00007632-200011150-00017
Macnab I. The surgery of lumbar disc degeneration. Surg Annu. 1976;8:447-80.
Lewandrowski KUPSTDECPDEC, et al. Minimal Clinically Important Difference in Patient-Reported Outcome Measures with the Transforaminal Endoscopic Decompression for Lateral Recess and Foraminal Stenosis. Int J Spine Surg. 2020;14:254-66. https://doi.org/10.14444/7034
Denis F, Basch E, Septans AL, et al. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. Jama. 2019;321:306-7. https://doi.org/10.1001/jama.2018.18085
Barcot O, Boric M, Dosenovic S, et al. Adequacy of risk of bias assessment in surgical vs non-surgical trials in Cochrane reviews: a methodological study. BMC Medical Research Methodology. 2020;20:240. https://doi.org/10.1186/s12874-020-01123-7
Gurusamy KS, Gluud C, Nikolova D, et al. Assessment of risk of bias in randomized clinical trials in surgery. British Journal of Surgery. 2009;96:342-9. https://doi.org/10.1002/bjs.6558
Nerland US, Jakola AS, Solheim O, et al. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study. Bmj. 2015;350:h1603. https://doi.org/10.1136/bmj.h1603
Jakola AS, Skjulsvik AJ, Myrmel KS, et al. Surgical resection versus watchful waiting in low-grade gliomas. Ann Oncol. 2017;28:1942-8. https://doi.org/10.1093/annonc/mdx230
von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. The Lancet. 2007;370:1453-7. https://doi.org/10.1016/S0140-6736(07)61602-X
Kaplan E, Meier P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association. 1958;53:457-81. https://doi.org/10.1080/01621459.1958.10501452
Altman D, Machin D, Bryant T, et al. Statistics with confidence: confidence intervals and statistical guidelinesed:. John Wiley & Sons; 2013.
Yeung A, Lewandrowski KU. Five-year clinical outcomes with endoscopic transforaminal foraminoplasty for symptomatic degenerative conditions of the lumbar spine: a comparative study of inside-out versus outside-in techniques. J Spine Surg. 2020;6:S66-83. https://doi.org/10.21037/jss.2019.06.08
Yeung A, Lewandrowski KU. Early and staged endoscopic management of common pain generators in the spine. J Spine Surg. 2020;6:S1-5. https://doi.org/10.21037/jss.2019.09.03
Lewandrowski K-U, Abraham I, Ramírez León JF, et al. A Proposed Personalized Spine Care Protocol (SpineScreen) to Treat Visualized Pain Generators: An Illustrative Study Comparing Clinical Outcomes and Postoperative Reoperations between Targeted Endoscopic Lumbar Decompression Surgery, Minimally Invasive TLIF and Open Laminectomy. Journal of Personalized Medicine. 2022;12:1065. https://doi.org/10.3390/jpm12071065
Ramirez Leon JF, Ardila AS, Rugeles Ortiz JG, et al. Standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF) with a threaded cylindrical peek cage: report of two cases. J Spine Surg. 2020;6. S275-S84. https://doi.org/10.21037/jss.2019.06.09
Ramirez Leon JF. The motivators to endoscopic spine surgery implementation in Latin America. J Spine Surg. 2020;6:S45-8. https://doi.org/10.21037/jss.2019.09.12
Ramirez LF, Thisted R. Complications and demographic characteristics of patients undergoing lumbar discectomy in community hospitals. Neurosurgery. 1989;25, 226-230 discussion 30-1. https://doi.org/10.1097/00006123-198908000-00012
Ruetten S, Komp M, Merk H, et al. Full-endoscopic interlaminar and transforaminal lumbar discectomy versus conventional microsurgical technique: a prospective, randomized, controlled study. Spine (Phila Pa 1976). 2008;33:931-9. https://doi.org/10.1097/BRS.0b013e31816c8af7
Osterman H, Seitsalo S, Karppinen J, et al. Effectiveness of microdiscectomy for lumbar disc herniation: a randomized controlled trial with 2 years of follow-up. Spine (Phila Pa 1976). 2006;31:2409-14. https://doi.org/10.1097/01.brs.0000239178.08796.52
Knight MT, Goswami A, Patko JT, et al. Endoscopic foraminoplasty: a prospective study on 250 consecutive patients with independent evaluation. J Clin Laser Med Surg. 2001;19:73-81. https://doi.org/10.1089/104454701750285395
Sampath P, Bendebba M, Davis JD, et al. Outcome in patients with cervical radiculopathy Prospective, multicenter study with independent clinical review. Spine (Phila Pa 1976). 1999;24:591-7. https://doi.org/10.1097/00007632-199903150-00021
Hermantin FU, Peters T, Quartararo L, et al. A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy. J Bone Joint Surg Am. 1999;81:958-65. https://doi.org/10.2106/00004623-199907000-00008
Choy DS. Percutaneous laser disc decompression (PLDD): twelve years' experience with 752 procedures in 518 patients. J Clin Laser Med Surg. 1998;16:325-31. https://doi.org/10.1089/clm.1998.16.325
Birkenmaier C, Komp M, Leu HF, et al. The current state of endoscopic disc surgery: review of controlled studies comparing full-endoscopic procedures for disc herniations to standard procedures. Pain Physician. 2013;16:335-44. https://doi.org/10.36076/ppj.2013/16/335
Ruetten S, Komp M, Merk H, et al. Full-endoscopic cervical posterior foraminotomy for the operation of lateral disc herniations using 5.9-mm endoscopes: a prospective, randomized, controlled study. Spine (Phila Pa 1976). 2008;33:940-8. https://doi.org/10.1097/BRS.0b013e31816c8b67
Ruetten S, Komp M, Merk H, et al. Recurrent lumbar disc herniation after conventional discectomy: a prospective, randomized study comparing full-endoscopic interlaminar and transforaminal versus microsurgical revision. J Spinal Disord Tech. 2009;22:122-9. https://doi.org/10.1097/BSD.0b013e318175ddb4
Lee DY, Shim CS, Ahn Y, et al. Comparison of percutaneous endoscopic lumbar discectomy and open lumbar microdiscectomy for recurrent disc herniation. J Korean Neurosurg Soc. 2009;46:515-21. https://doi.org/10.3340/jkns.2009.46.6.515
Kong L, Shang XF, Zhang WZ, et al. Percutaneous endoscopic lumbar discectomy and microsurgical laminotomy: A prospective, randomized controlled trial of patients with lumbar disc herniation and lateral recess stenosis. Orthopade. 2019;48:157-64. https://doi.org/10.1007/s00132-018-3610-z
Rong L. Erratum. Percutaneous transforaminal endoscopic discectomy compared with microendoscopic discectomy for lumbar disc herniation: 1-year results of an ongoing randomized controlled trial. J Neurosurg Spine. 2019:1-3. https://doi.org/10.3171/2019.5.SPINE161434a
Chiarotto A, Maxwell LJ, Terwee CB, et al. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016;96:1620-37. https://doi.org/10.2522/ptj.20150420
Barber MD, Chen Z, Lukacz E, et al. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011;30:541-6. https://doi.org/10.1002/nau.20934
Jenkinson C, Layte R. Development and testing of the UK SF-12 (short form health survey). J Health Serv Res Policy. 1997;2:14-8. https://doi.org/10.1177/135581969700200105
