Diagnostic randomized controlled trials: the final frontier

Trials

Dean Fergusson²  Tim Ramsay¹  Marc Rodger³ 

[1] Ottawa Methods Centre, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada;The Ottawa Hospital, Clinical Epidemiology Program, 501 Smyth Road, Box 201, Ottawa, ON K1H 8L6, Canada;Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada

关键词: randomization;    diagnostic tests;    Clinical trials;   

Others  :  1095400
DOI  :  10.1186/1745-6215-13-137

 received in 2011-12-23, accepted in 2012-06-14,  发布年份 2012

【 摘 要 】

Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

【 授权许可】

   
2012 Rodger et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M: A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: d-dimer testing compared with repeated ultrasonography. Ann Intern Med 2005, 142:490-496.
• [2]Jaeschke R, Guyatt G, Sackett DL: Users’ guide to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? JAMA 1994, 271:703-707.
• [3]Jaeschke R, Guyatt G, Sackett DL: Users’ guides to the medical literature. III. How to use an article about a diagnostic test A. Are the results of the study valid? JAMA 1994, 271:389-391.
• [4]Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, Bossuyt PM: Empirical evidence of design-related bias in studies of diagnostic tests. JAMA 1999, 282:1061-1066.
• [5]Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG, Standards for Reporting of Diagnostic Accuracy: The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med 2003, 138:1W-12W.
• [6]Guyatt GH, Tugwell PX, Feeny DH, Haynes RB, Drummond M: A framework for clinical evaluation of diagnostic technologies. CMAJ 1986, 134:587-594.
• [7]Deeks JJ: Using evaluations of diagnostic tests: understanding their limitations and making the most of available evidence. Ann Oncol 1999, 10:761-768.
• [8]Lord SJ, Irwig L, Simes RJ: When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Ann Intern Med 2006, 144:850-855.
• [9]Selman TJ, Morris RK, Zamora J, Khan KS: The quality of reporting of primary test accuracy studies in obstetrics and gynaecology: application of the STARD criteria. BMC Womens Health 2011, 11:8. BioMed Central Full Text
• [10]Wilczynski NL: Quality of reporting of diagnostic accuracy studies: no change since stard statement publication - before-and-after study. Radiology 2008, 248:817-823.
• [11]Bossuyt PM, Lijmer JG, Mol BW: Randomised comparisons of medical tests: sometimes invalid, not always efficient. Lancet 2000, 356:1844-1847.