Is statistical significance clinically important? - A guide to judge the clinical relevance of study findings

Journal of Long-Term Effects of Medical Implants

Volumn 17, Issue 2, 2007, Pages 173-179

  Sierevelt, Inger N ^a   Van Oldenrijk, Jakob ^a   Poolman, Rudolf W ^b  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b ONZE LIEVE VROUWE GASTHUIS   (Netherlands)

Author keywords

Clinical relevance; p value; Sample size; Statistical significance

Indexed keywords

ORTHOPEDICS; PATIENT TREATMENT; RISK ASSESSMENT; STATISTICAL METHODS;

CLINICAL RELEVANCE; MULTIPLE SECONDARY OUTCOME; P VALUE; SAMPLE SIZE; STATISTICAL SIGNIFICANCE;

IMPLANTS (SURGICAL);

ALERTNESS; ANALYTICAL ERROR; CALCULATION; CLINICAL PRACTICE; CONFIDENCE INTERVAL; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; HYPOTHESIS; METHODOLOGY; ORTHOPEDICS; OUTCOME ASSESSMENT; REVIEW; SAMPLE SIZE; STATISTICAL SIGNIFICANCE;

CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; HUMANS; ORTHOPEDICS;

EID: 41949124211     PISSN: 10506934     EISSN: None     Source Type: Journal    
DOI: 10.1615/JLongTermEffMedImplants.v17.i2.100     Document Type: Review

References (29)

1. Bhandari M, Zlowodzki M, Cole PA. From eminence-based practice to evidence-based practice: a paradigm shift. Minn Med. 2004 Apr;87:51-4.
2. Cockburn DM. How to make clinical decisions from statistics. Clin Exp Optometry. 2006;89:176-83.
3. Simon R. Confidence intervals for reporting results of clinical trials. Ann Intern Med. 1986 Sep;105:429-35.
4. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.
5. Chan KB, Man-Son-Hing M, Molnar FJ, Laupacis A. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ. 2001 Oct 30;165:1197-202.
6. Tulder M. v, Malmivaara A, Hayden J, Koes B. Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example. Spine. 2007 Jul 15;32(16):1785-90.
7. Bhandari M, Montori VM, Schemitsch EH. The undue influence of significant p-values on the perceived importance of study results. Acta Orthop. 2005 Jun;76:291-5.
8. Poolman RW, Kerkhoff s GM, Struijs PA, Bhandari M, International Evidence-Based Orthopedic Surgery Working Group. Don't be misled by the orthopedic literature: tips for critical appraisal. Acta Orthop. 2007 Apr;78(2):162-71.
9. Ranstam J. A common misconception about p-values and its consequences. Acta Orthop Scand. 1996 Oct;67(5):505-7.
10. Piantadosi S. Clinical trials. a methodologic perspective. 2nd ed. Hoboken, NJ: Wiley; 2005.
11. Amercan College of Physicians-American Society of Internal Medicine. Primer on statistical significance and p values. Eff ective Clinical Practice Primers. 2001;4:183-4. Available at www.acponline.org
12. Bhandari M, Tornetta P III. Issues in the hierarchy of study design, hypothesis testing, and presentation of results. Techniq Orthop. 2004;19:57-65.
13. Bhandari M, Whang W, Kuo JC, Devereaux PJ, Sprague S, Tornetta P, III. The risk of false-positive results in orthopaedic surgical trials. Clin Orthop Relat Res. 2003 Aug;(413):63-9.
14. Guyatt G, Jaeschke R, Heddle N, Cook D, Shannon H, Walter S. Basic statistics for clinicians: 1. hypothesis testing. CMAJ. 1995 Jan 1;152:27-32.
15. Freedman KB, Bernstein J. Sample size and statistical power in clinical orthopaedic research. J Bone Joint Surg Am. 1999 Oct;81:1454-60.
16. Ogonda L, Wilson R, Archbold P, Lawlor M, Humphreys P, O'Brien S, et al. A minimal-incision technique in total hip arthroplasty does not improve early postoperative outcomes. A prospective, randomized, controlled trial. J Bone Joint Surg Am. 2005 Apr;87:701-10.
17. Bailey CS, Fisher CG, Dvorak MF. Type II error in the spine surgical literature. Spine. 2004 May 15;29:1146-9.
18. Lochner HV, Bhandari M, Tornetta P, III. Type-II error rates (beta errors) of randomized trials in orthopaedic trauma. J Bone Joint Surg Am. 2001 Nov;83-A:1650-5.
19. van Vugt VAB, Oosterwijk WM, Goris RJA. Osteosynthesis versus endoprosthesis in the treatment of unstable intracapsular hip fractures in the elderly. a randomised clinical trial. Arch Orthop Trauma Surg. 1993;113:39-45.
20. Bhandari M, Devereaux PJ, Swiontkowski MF, Tornetta P, III, Obremskey W, Koval KJ, et al. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck: a meta-analysis. J Bone Joint Surg Am. 2003;85:1673-81.
21. Zlowodzki M, Bhandari M, Brown G, Cole PA, Swiontkowski MF. Planning a randomized trial. determining the study sample size. Techniq Orthop. 2004;19:72-6.
22. Freedman KB, Back S, Bernstein J. Sample size and statistical power of randomised, controlled trials in orthopaedics. J Bone Joint Surg Br. 2001 Apr;83:397-402.
23. Brasher PM, Brant RF. Sample size calculations in randomized trials: common pitfalls. Can J Anaesth. 2007 Feb;54:103-6.
24. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. ascertaining the minimal clinically important diff erence. Control Clin Trials. 1989 Dec;10:407-15.
25. Make B. How can we assess outcomes of clinical trials: the MCID approach. COPD. 2007 Sep;4:191-4.
26. Sloan JA. Assessing the minimally clinically significant diff erence: scientific considerations, challenges and solutions. COPD. 2005 Mar;2:57-62.
27. Willenheimer R. Statistical significance versus clinical relevance in cardiovascular medicine. Prog Cardiovasc Dis. 2001 Nov;44:155-67.
28. Bhandari M, Guyatt GH, Swiontkowski MF. User's guide to the orthopaedic literature: how to use an article about a surgical therapy. J Bone Joint Surg Am. 2001 Jun;83-A:916-26.
29. Bhandari M, Haynes RB. How to appraise the effectiveness of treatment. World J Surg. 2005 May;29:570-5.