Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions

Journal of Orthopaedic Surgery and Research

Volumn 10, Issue 1, 2015, Pages

  Katz, Nathaniel P ^a,b   Paillard, Florence C ^a   Ekman, Evan ^b,c  

^a Analgesic Solutions   (United States)

^b TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c APPALACHIAN STATE UNIVERSITY   (United States)

Author keywords

Anchor based methods; Distribution based methods; MCID; MDC; Orthopedic surgery; Pain

Indexed keywords

HUMAN; ORTHOPEDIC SURGERY; OUTCOME ASSESSMENT; PROCEDURES;

HUMANS; ORTHOPEDIC PROCEDURES; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 84924125216     PISSN: None     EISSN: 1749799X     Source Type: Journal    
DOI: 10.1186/s13018-014-0144-x     Document Type: Article

References (31)

1. Pham T, Der Heijde DV, Lassere M, Altman RD, Anderson JJ, Bellamy N, et al. Outcome variables for osteoarthritis clinical trials: the OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30:1648-1654
2. Morley S, Williams AC. Conducting and evaluating treatment outcome studies. In: Turk DC, Gatchel RJ, editors. Psychological approaches to pain management: a practitioner's handbook. 2nd ed. New York: Guilford; 2002.
3. Copay AG, Subach BR, Glassman SD, Polly Jr DW, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7:541-6.
4. Kane RC. The clinical significance of statistical significance. Oncologist. 2008;13:1129-33.
5. Man-Son-Hing M, Laupacis A, O'Rourke K, Molnar FJ, Mahon J, Chan KB, et al. Determination of the clinical importance of study results. J Gen Intern Med. 2002;17:469-76.
6. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, et al. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146:238-44.
7. Wells G, Beaton D, Shea B, Boers M, Simon L, Strand V, et al. Minimal clinically significant important differences: review of methods. J Rheumatol. 2001;28:406-12.
8. Jaeschke R, Singer JA, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407-15.
9. Beaton DE, Bombardier C, Katz JN, Wright JG, Wells G, Boers M, et al. Looking for important change/differences in studies of responsiveness. OMERACT MCID working group. Outcome measures in rheumatology. Minimal clinically important difference. J Rheumatol. 2001;28:400-5.
10. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheumat Dis. 2005;64:29-33.
11. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149-58.
12. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27:2635-41.
13. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001;45:384-91.
14. Escobar A, Quintana JM, Bilbao A, Aróstegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage. 2007;15:273-80.
15. Quintana JM, Aguirre U, Barrio I, Orive M, Garcia S, Escobar A. Outcomes after total hip replacement based on patients' baseline status: what results can be expected? Arthritis Care Res. 2012;64:563-72.
16. Escobar A, García Pérez L, Herrera-Espiñeira C, Aizpuru F, Sarasqueta C, Gonzalez Sáenz De Tejada M, et al. Total knee replacement; minimal clinically important differences and responders. Osteoarthritis Cartilage. 2013;21:2006-12.
17. Carreon LY, Bratcher KR, Canan CE, Burke LO, Djurasovic M, Glassman SD. Differentiating minimum clinically important difference for primary and revision lumbar fusion surgeries. J Neurosurg Spine. 2013;18:102-6.
18. Gum JL, Glassman SD, Carreon LY. Clinically important deterioration in patients undergoing lumbar spine surgery: a choice of evaluation methods using the Oswestry Disability Index, 36-Item Short Form Health Survey, and pain scales: clinical article. J Neurosurg Spine. 2013;19:564-8.
19. Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010;10:469-74.
20. Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008;8:968-74.
21. Solberg T, Johnsen LG, Nygaard ØP, Grotle M. Can we define success criteria for lumbar disc surgery?: estimates for a substantial amount of improvement in core outcome measures. Acta Orthop. 2013;84:196-201.
22. Parker SL, Godil SS, Shau DN, Mendenhall SK, McGirt MJ. Assessment of the minimum clinically important difference in pain, disability, and quality of life after anterior cervical discectomy and fusion: clinical article. J Neurosurg Spine. 2013;18:154-60.
23. Stauffer ME, Taylor SD, Watson DJ, Peloso PM, Morrison A. Definition of nonresponse to analgesic treatment of arthritic pain: an analytical literature review of the smallest detectable difference, the minimal detectable change, and the minimal clinically important difference on the pain visual analog scale. Int J Inflam. 2011;2011:231926.
24. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307-10.
25. Lassere M, Boers M, van der Heijde D, Edmons J, Saudan A, Verhoeven AC. Smallest detectable difference in radiological progression. J Rheumatol. 1999;26:731-9.
26. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105-21.
27. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582-92.
28. de Vet H, Ostelo R, Terwee C, van der Roer N, Knol DL, Beckerman H, et al. Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach. Qual Life Res. 2007;16:131-42.
29. Hofstetter CP, Shin B, Tsiouris AJ, Elowitz E, Härtl R. Radiographic and clinical outcome after 1- and 2-level transsacral axial interbody fusion: clinical article. J Neurosurg Spine. 2013;19:454-63.
30. American Academy of Orthopaedic Surgeons (AAOS). Treatment of osteoarthritis of the knee evidence-based guideline, 2nd edition; Adopted by the American Academy of Orthopedic Surgeons Board of Directors. May 18, 2013.
31. Bannuru RR, Vaysbrot EE, McIntyre LF. Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark? Arthroscopy. 2014;30:86-9.