Skip to main content

Advertisement

SpringerLink
Log in

Eligibility criteria in knee osteoarthritis clinical trials: systematic review

  • Review Article
  • Published:
Clinical Rheumatology Aims and scope Submit manuscript

Abstract

There is an increasing concern over generalizability of trial results. We investigated eligibility criteria of knee osteoarthritis clinical trials. Eligible trials were randomized, placebo-controlled trials that were identified by searches in MEDLINE, SCOPUS, and the Cochrane Central Register of Controlled Trials. We then attempted to extract data on the eligibility criteria by employing predetermined criteria. From 355 randomized knee osteoarthritis trials, we reviewed data categorized by non-osteoarthritis-related and osteoarthritis-related factors. A variety of items were used in the eligibility criteria. Regarding the non-osteoarthritis-related factors, ethical considerations, such as inability to give an informed consent (79.4 %) or medical conditions potential for risks by test treatments (56.0 %) or by participation in a trial (57.2 %), were the common reasons for excluding patients from a trial. Concerning the osteoarthritis-related factors, most of the trials did not specify age and symptom severity. When trials specifying these items were investigated, patients with 40 to 80 years in age and grade 2 in the Kellgren–Lawrence scale were mostly included into a trial. For the pain intensity, patients with ≥20–40 in the 100-mm visual analog scale and ≥6–8 in the WOMAC pain subscale were commonly enrolled into a trial. These findings warrant further investigation on the generalizability of trial results.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Colditz GA, Miller JN, Mosteller F (1989) How study design affects outcomes in comparisons of therapy. I: Medical Stat Med 8(4):441–454

    Article  CAS  Google Scholar 

  2. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P (2007) OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthr Cartil 15(9):981–1000

    Article  PubMed  CAS  Google Scholar 

  3. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P (2008) OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil 16(2):137–162

    Article  PubMed  CAS  Google Scholar 

  4. Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P (2010) OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthr Cartil 18(4):476–499

    Article  PubMed  CAS  Google Scholar 

  5. Sweeney KG, Gray DP, Steele R, Evans P (1995) Use of warfarin in non-rheumatic atrial fibrillation: a commentary from general practice. Br J Gen Pract 45:153–158

    PubMed  CAS  Google Scholar 

  6. McKee M, Britton A, Black N, McPherson K, Sanderson C, Bain C (1999) Methods in health services research. Interpreting the evidence: choosing between randomised and non-randomised studies. BMJ 319(7205):312–315

    Article  PubMed  CAS  Google Scholar 

  7. Lloyd-Jones DM, O'Donnell CJ, D'Agostino RB, Massaro J, Silbershatz H, Wilson PW (2001) Applicability of cholesterol-lowering primary prevention trials to a general population: the Framingham heart study. Arch Intern Med 161:949–954

    Article  PubMed  CAS  Google Scholar 

  8. Sharpe N (2002) Clinical trials and the real world: selection bias and generalisability of trial results. Cardiovasc Drugs Ther 16:75–77

    Article  PubMed  Google Scholar 

  9. Heiat A, Gross CP, Krumholz HM (2002) Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med 162:1682–1688

    Article  PubMed  Google Scholar 

  10. Fossa SD, Skovlund E (2002) Selection of patients may limit the generalizability of results from cancer trials. Acta Oncol 41:131–137

    Article  PubMed  Google Scholar 

  11. Zimmerman M, Chelminski I, Posternak MA (2004) Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included. J Nerv Ment Dis 192:87–94

    Article  PubMed  Google Scholar 

  12. Zimmerman M, Chelminski I, Posternak MA (2005) Generalizability of antidepressant efficacy trials: differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial. Am J Psychiatry 162(7):1370–1372

    Article  PubMed  Google Scholar 

  13. Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, Gange SJ, Anastos K, Holman S, Levine A, Greenblatt RM (2005) Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS 19(16):1885–1896

    Article  PubMed  Google Scholar 

  14. George SL (1996) Reducing patient eligibility criteria in cancer clinical trials. J Clin Oncol 14(4):1364–1370

    PubMed  CAS  Google Scholar 

  15. Ware JH, Hamel MB (2011) Pragmatic trials—guides to better patient care? N Engl J Med 364(18):1685–1687

    Article  PubMed  CAS  Google Scholar 

  16. Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S (1996) Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop Osteoarthritis Cartilage 4(4):217–243

    Article  CAS  Google Scholar 

  17. Koog YH, Gil M, We SR, Wi H, Min BI (2013) Barriers to participant retention in knee osteoarthritis clinical trials: a systematic review. Semin Arthritis Rheum 42(4):346–354

    Article  PubMed  Google Scholar 

  18. Ryang We S, Koog YH, Jeong KI, Wi H (2013) Effects of pulsed electromagnetic field on knee osteoarthritis: a systematic review. Rheumatology (Oxford) 52(5):815–824

    Article  Google Scholar 

  19. We SR, Jeong EO, Koog YH, Min BI (2012) Effects of nutraceuticals on knee osteoarthritis: systematic review. Afr J Biotechnol 11(12):2814–2821

    CAS  Google Scholar 

  20. van Spall HG, Toren A, Kiss A, Fowler RA (2007) Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA 297(11):1233–1240

    Article  PubMed  Google Scholar 

  21. Spector TD, Cooper C (1993) Radiographic assessment of osteoarthritis in population studies: whither Kellgren and Lawrence? Osteoarthr Cartil 1(4):203–206

    Article  PubMed  CAS  Google Scholar 

  22. Ward HJ, Cousens SN, Smith-Bathgate B, Leitch M, Everington D, Will RG, Smith PG (2004) Obstacles to conducting epidemiological research in the UK general population. BMJ 329(7460):277–279

    Article  PubMed  Google Scholar 

  23. Hewison J, Haines A (2006) Overcoming barriers to recruitment in health research. BMJ 333(7562):300–302

    Article  PubMed  Google Scholar 

  24. Junghans C, Jones M (2007) Consent bias in research: how to avoid it. Heart 93(9):1024–1025

    Article  PubMed  Google Scholar 

  25. Buckley B, Murphy AW, Byrne M, Glynn L (2007) Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease. Heart 93(9):1116–1120

    Article  PubMed  Google Scholar 

  26. Arden N, Nevitt MC (2006) Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol 20(1):3–25

    Article  PubMed  Google Scholar 

  27. Garstang SV, Stitik TP (2006) Osteoarthritis: epidemiology, risk factors, and pathophysiology. Am J Phys Med Rehabil 85(11 Suppl):S2–S11, quiz S12-4

    Article  PubMed  Google Scholar 

  28. van Saase JL, van Romunde LK, Cats A, Vandenbroucke JP, Valkenburg HA (1989) Epidemiology of osteoarthritis: Zoetermeer survey. Comparison of radiological osteoarthritis in a Dutch population with that in 10 other populations. Ann Rheum Dis 48(4):271–280

    Article  PubMed  Google Scholar 

Download references

Disclosures

None.

Author information

Authors and Affiliations

  1. Honam Research Center, Medifarm Hospital, Suncheon, South Korea

    Yun Hyung Koog, Hyungsun Wi & Won Young Jung

  2. Department of Oriental Medicine, Medifarm Hospital, Suncheon, South Korea

    Yun Hyung Koog

  3. Department of Neurology, Medifarm Hospital, Suncheon, South Korea

    Won Young Jung

Authors
  1. Yun Hyung Koog
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hyungsun Wi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Won Young Jung
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yun Hyung Koog.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Koog, Y.H., Wi, H. & Jung, W.Y. Eligibility criteria in knee osteoarthritis clinical trials: systematic review. Clin Rheumatol 32, 1569–1574 (2013). https://doi.org/10.1007/s10067-013-2342-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10067-013-2342-z

Keywords

Search

Navigation