Advertisement

What Is the Hierarchy of Clinical Evidence?

  • Vishal S. Desai
  • Christopher L. Camp
  • Aaron J. KrychEmail author
Chapter
First Online:

Abstract

Any clinical question can be investigated in more than one way. The method by which a hypothesis is tested not only affects the results and format of presentation, but it also serves to provide varying degrees of evidence in support of (or against) the examiner’s question. In addition, based on how they were obtained, study results may be more equipped to imply causation (over simple correlation) and be more (or less) vulnerable to error. In order to clearly stratify results based on the strength of evidence they provide, a hierarchy of clinical evidence has been developed. A robust explanation of this hierarchy is essential to any discussion of evidence-based medicine and clinical research design. Using an example-based analysis of a clinically relevant orthopedic medicine topic, this chapter will serve to elucidate how the scientific question and goals of the investigator are used to select the appropriate study design. Furthermore, it will highlight the principles, benefits, and limitations of these various study designs. And finally, this chapter will introduce how to hierarchically organize the relative strength of results to ensure that scientific evidence is presented and interpreted in a clinically relevant manner.

Keywords

Clinical evidence Research Hierarchy Orthopedic Study design Scientific evidence Evidence-based medicine 
This is a preview of subscription content, log in to check access.

References

  1. 1.
    Audige L, Ayeni OR, Bhandari M, Boyle BW, Briggs KK, Chan K, Chaney-Barclay K. A practical guide to research: design, execution, and publication. Arthroscopy. 2011;27(4 Suppl):S1–112.  https://doi.org/10.1016/j.arthro.2011.02.001.CrossRefPubMedGoogle Scholar
  2. 2.
    Audige L, Bhandari M, Griffin D, Middleton P, Reeves BC. Systematic reviews of nonrandomized clinical studies in the orthopaedic literature. Clin Orthop Relat Res. 2004;427:249–57.CrossRefGoogle Scholar
  3. 3.
    Bhandari M, Morrow F, Kulkarni AV, Tornetta P 3rd. Meta-analyses in orthopaedic surgery. A systematic review of their methodologies. J Bone Joint Surg Am. 2001;83-a(1):15–24.CrossRefGoogle Scholar
  4. 4.
    Bryant DM, Willits K, Hanson BP. Principles of designing a cohort study in orthopaedics. J Bone Joint Surg Am. 2009;91(Suppl 3):10–4.  https://doi.org/10.2106/jbjs.h.01597.CrossRefPubMedGoogle Scholar
  5. 5.
    Chaudhry H, Mundi R, Singh I, Einhorn TA, Bhandari M. How good is the orthopaedic literature? Indian J Orthop. 2008;42(2):144–9.  https://doi.org/10.4103/0019-5413.40250.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887–92.CrossRefGoogle Scholar
  7. 7.
    Cook C, Sheets C. Clinical equipoise and personal equipoise: two necessary ingredients for reducing bias in manual therapy trials. J Man Manip Ther. 2011;19(1):55–7.  https://doi.org/10.1179/106698111x12899036752014.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Court-Brown CM, McQueen MM. How useful are meta-analyses in orthopedic trauma? J Trauma. 2011;71(5):1395–9.  https://doi.org/10.1097/TA.0b013e318208f983.CrossRefPubMedGoogle Scholar
  9. 9.
    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):3679–86.  https://doi.org/10.1007/s11999-013-3159-4.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177–88.CrossRefGoogle Scholar
  11. 11.
    Desai N, Bjornsson H, Musahl V, Bhandari M, Petzold M, Fu FH, Samuelsson K. Anatomic single- versus double-bundle ACL reconstruction: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2014;22(5):1009–23.  https://doi.org/10.1007/s00167-013-2811-6.CrossRefPubMedGoogle Scholar
  12. 12.
    Dowrick AS, Bhandari M. Ethical issues in the design of randomized trials: to sham or not to sham. J Bone Joint Surg Am. 2012;94(Suppl 1):7–10.  https://doi.org/10.2106/jbjs.l.00298.CrossRefPubMedGoogle Scholar
  13. 13.
    MARS Group. Effect of graft choice on the outcome of revision anterior cruciate ligament reconstruction in the Multicenter ACL Revision Study (MARS) Cohort. Am J Sports Med. 2014;42(10):2301–10.  https://doi.org/10.1177/0363546514549005.CrossRefGoogle Scholar
  14. 14.
    Elamin MB, Montori VM. The hierarchy of evidence: from unsystematic clinical observations to systematic reviews. In: Burneo JG, Demaerschalk BM, Jenkins ME, editors. Neurology: an evidence-based approach. New York, NY: Springer; 2012. p. 11–24.CrossRefGoogle Scholar
  15. 15.
    Ellenberg JH. Intent-to-treat analysis versus as-treated analysis. Drug Inf J. 1996;30(2):535–44.  https://doi.org/10.1177/009286159603000229.CrossRefGoogle Scholar
  16. 16.
    Farber J, Harris JD, Kolstad K, McCulloch PC. Treatment of anterior cruciate ligament injuries by major league soccer team physicians. Orthop J Sports Med. 2014;2(11):2325967114559892.  https://doi.org/10.1177/2325967114559892.CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Gopikrishna V. A report on case reports. J Conserv Dent. 2010;13(4):265–71.  https://doi.org/10.4103/0972-0707.73375.CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Grant HM, Tjoumakaris FP, Maltenfort MG, Freedman KB. Levels of evidence in the clinical sports medicine literature: are we getting better over time? Am J Sports Med. 2014;42(7):1738–42.  https://doi.org/10.1177/0363546514530863.CrossRefPubMedGoogle Scholar
  19. 19.
    Greenhalgh T. How to read a paper. Getting your bearings (deciding what the paper is about). BMJ. 1997;315(7102):243–6.CrossRefGoogle Scholar
  20. 20.
    Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109–12.  https://doi.org/10.4103/2229-3485.83221.CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    Guyatt G, Rennie D, Meade M, Cook D. Users’ guides to the medical literature: a manual for evidence-based clinical practice. Chicago, IL: AMA Press; 2002.Google Scholar
  22. 22.
    Guyatt GH, Haynes RB, Jaeschke RZ, Cook DJ, Green L, Naylor CD, Wilson MC. Users’ Guides to the Medical Literature: XXV. Evidence-based medicine: principles for applying the Users’ Guides to patient care. Evidence-Based Medicine Working Group. JAMA. 2000;284(10):1290–6.CrossRefGoogle Scholar
  23. 23.
    Guyatt GH, Sackett DL, Sinclair JC, Hayward R, Cook DJ, Cook RJ. Users’ guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA. 1995;274(22):1800–4.CrossRefGoogle Scholar
  24. 24.
    Heng CH, Wang Bde H, Chang PC. Distal femoral fracture after double-bundle anterior cruciate ligament reconstruction surgery. Am J Sports Med. 2015;43(4):953–6.  https://doi.org/10.1177/0363546514563908.CrossRefPubMedGoogle Scholar
  25. 25.
    Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ (Clin Res ed). 1999;319(7211):670–4.CrossRefGoogle Scholar
  26. 26.
    Huang X, Lin J, Demner-Fushman D. Evaluation of PICO as a knowledge representation for clinical questions. AMIA Ann Symp Proc. 2006;2006:359–63.Google Scholar
  27. 27.
    Huth EJ. Writing and publishing in medicine. Baltimore: Lippincott Williams and Wilkins; 1999. p. 103–10.Google Scholar
  28. 28.
    Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014;6(1):103–9.  https://doi.org/10.4055/cios.2014.6.1.103.CrossRefPubMedPubMedCentralGoogle Scholar
  29. 29.
    Kim SH, Jung YB, Song MK, Lee SH, Jung HJ, Lee HJ, Jung HS. Comparison of double-bundle anterior cruciate ligament (ACL) reconstruction and single-bundle reconstruction with remnant pull-out suture. Knee Surg Sports Traumatol Arthrosc. 2014;22(9):2085–93.  https://doi.org/10.1007/s00167-013-2619-4.CrossRefPubMedGoogle Scholar
  30. 30.
    Kopec JA, Esdaile JM. Bias in case-control studies. A review. J Epidemiol Community Health. 1990;44(3):179–86.CrossRefGoogle Scholar
  31. 31.
    Mantel N, Brown C, Byar DP. Tests for homogeneity of effect in an epidemiologic investigation. Am J Epidemiol. 1977;106(2):125–9.CrossRefGoogle Scholar
  32. 32.
    Mayr HO, Benecke P, Hoell A, Schmitt-Sody M, Bernstein A, Suedkamp NP, Stoehr A. Single-bundle versus double-bundle anterior cruciate ligament reconstruction: a comparative 2-year follow-up. Arthroscopy. 2016;32(1):34–42.  https://doi.org/10.1016/j.arthro.2015.06.029.CrossRefPubMedGoogle Scholar
  33. 33.
    McCarthy CM. Randomized controlled trials. Plast Reconstr Surg. 2011;127(4):1707–12.  https://doi.org/10.1097/PRS.0b013e31820da3eb.CrossRefPubMedGoogle Scholar
  34. 34.
    Mehta S, Myers TG, Lonner JH, Huffman GR, Sennett BJ. The ethics of sham surgery in clinical orthopaedic research. J Bone Joint Surg Am. 2007;89(7):1650–3.  https://doi.org/10.2106/jbjs.f.00563.CrossRefPubMedGoogle Scholar
  35. 35.
    Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.  https://doi.org/10.1371/journal.pmed.1000097.CrossRefPubMedPubMedCentralGoogle Scholar
  36. 36.
    Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ. 2001;165(10):1339–41.PubMedPubMedCentralGoogle Scholar
  37. 37.
    Mundi R. Design and execution of clinical trials in orthopaedic surgery. Bone Joint Res. 2014;3(5):161–8.  https://doi.org/10.1302/2046-3758.35.2000280.CrossRefPubMedPubMedCentralGoogle Scholar
  38. 38.
    Nissen T, Wynn R. The clinical case report: a review of its merits and limitations. BMC Res Notes. 2014;7:264.  https://doi.org/10.1186/1756-0500-7-264.CrossRefPubMedPubMedCentralGoogle Scholar
  39. 39.
    Parkinson B, Robb C, Thomas M, Thompson P, Spalding T. Factors that predict failure in anatomic single-bundle anterior cruciate ligament reconstruction. Am J Sports Med. 2017;45(7):1529–36.  https://doi.org/10.1177/0363546517691961.CrossRefPubMedGoogle Scholar
  40. 40.
    The periodic health examination. Canadian Task Force on the Periodic Health Examination. Can Med Assoc J. 1979;121(9):1193–254.Google Scholar
  41. 41.
    Röhrig B, du Prel JB, Blettner M. Study design in medical research: part 2 of a series on the evaluation of scientific publications. Dtsch Arztebl Int. 2009;106(11):184–9.  https://doi.org/10.3238/arztebl.2009.0184.CrossRefPubMedPubMedCentralGoogle Scholar
  42. 42.
    Ryan J, Magnussen RA, Cox CL, Hurbanek JG, Flanigan DC, Kaeding CC. ACL reconstruction: do outcomes differ by sex? A systematic review. J Bone Joint Surg Am. 2014;96(6):507–12.  https://doi.org/10.2106/jbjs.m.00299.CrossRefPubMedGoogle Scholar
  43. 43.
    Schardt C, Adams MB, Owens T, Keitz S, Fontelo P. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Mak. 2007;7:16.  https://doi.org/10.1186/1472-6947-7-16.CrossRefPubMedPubMedCentralGoogle Scholar
  44. 44.
    Sheiner LB. Is intent-to-treat analysis always (ever) enough? Br J Clin Pharmacol. 2002;54(2):203–11.CrossRefGoogle Scholar
  45. 45.
    Shore BJ, Nasreddine AY, Kocher MS. Overcoming the funding challenge: the cost of randomized controlled trials in the next decade. J Bone Joint Surg Am. 2012;94(Suppl 1):101–6.  https://doi.org/10.2106/jbjs.l.00193.CrossRefPubMedGoogle Scholar
  46. 46.
    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(20):2441–50.  https://doi.org/10.1001/jama.296.20.2441.CrossRefPubMedPubMedCentralGoogle Scholar
  47. 47.
    Wenger DR. Limitations of evidence-based medicine: the role of experience and expert opinion. J Pediatr Orthop. 2012;32(Suppl 2):S187–92.  https://doi.org/10.1097/BPO.0b013e318259f2ed.CrossRefPubMedGoogle Scholar
  48. 48.
    Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am. 2003;85-a(1):1–3.CrossRefGoogle Scholar
  49. 49.
    Zantop T, Kubo S, Petersen W, Musahl V, Fu FH. Current techniques in anatomic anterior cruciate ligament reconstruction. Arthroscopy. 2007;23(9):938–47.  https://doi.org/10.1016/j.arthro.2007.04.009.CrossRefPubMedGoogle Scholar

Copyright information

© ISAKOS 2019

Authors and Affiliations

  • Vishal S. Desai
    • 1
  • Christopher L. Camp
    • 1
  • Aaron J. Krych
    • 1
    Email author
  1. 1.Department of Orthopedic Surgery and Sports MedicineMayo ClinicRochesterUSA

Personalised recommendations

Cite chapter

Buy options