Assessing the value of diagnostic tests: A framework for designing and evaluating trials

BMJ (Online)

Volumn 344, Issue 7847, 2012, Pages

  Ferrante Di Ruffano, Lavinia ^a   Hyde, Christopher J ^b   McCaffery, Kirsten J ^c   Bossuyt, Patrick M M ^d   Deeks, Jonathan J ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b UNIVERSITY OF EXETER   (United Kingdom)

^c UNIVERSITY OF SYDNEY   (Australia)

^d UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BREAST CANCER; CLINICAL TRIAL (TOPIC); DIAGNOSTIC TEST; DIAGNOSTIC VALUE; DISEASE COURSE; FEASIBILITY STUDY; HEALTH STATUS; HUMAN; MEDICAL DECISION MAKING; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT COMPLIANCE; PHYSICIAN ATTITUDE; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SENSITIVITY AND SPECIFICITY; EVALUATION; METHODOLOGY; PREDICTIVE VALUE; REVIEW; STANDARD;

CLINICAL TRIALS AS TOPIC; DIAGNOSTIC TESTS, ROUTINE; EVALUATION STUDIES AS TOPIC; HEALTH STATUS; HUMANS; PREDICTIVE VALUE OF TESTS; SENSITIVITY AND SPECIFICITY;

EID: 84858061434     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.e686     Document Type: Article

References (34)

1. Bossuyt PM, Irwig L, Craig J, Glasziou P. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ 2006;332:1089-92. (Pubitemid 44365494)
2. Leeflang MMG, Deeks JJ, Gatsonis C, Bossuyt PMM, on behalf of the Cochrane Diagnostic Test Accuracy Working Group. Systematic reviews of diagnostic test accuracy. Ann Intern Med 2008;149:889-97.
3. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making 1991;11:88-94.
4. Lijmer JG, Bossuyt PMM. Various randomized designs can be used to evaluate medical tests. J Clin Epidemiol 2009;62:364-73.
5. Fineberg HV. Evaluation of computed tomography: achievement and challenge. Am J Roentgenol 1978;131:1-4.6
6. Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. Gradingquality of evidence and strength of recommendations for diagnostic tests and strategies.BMJ 2008;336:1106-10.
7. Canadian Critical Care Trials Group. Randomized trial of diagnostic techniques for ventilator-associated pneumonia. N Engl J Med 2006;355:2619-30.
8. Sutton AJ, Cooper NJ, Goodacre S, Stevenson M.Integration of meta-analysis and economic decision modeling for evaluating diagnostic tests. Med Decis Making 2008;28:650-67.
9. Ferrante di Ruffano L, Davenport C, Eisinga A, Hyde C, Deeks JJ. A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare. J Clin Epidemiol 2012;65:282-7.
10. Bossuyt PMM, Lijmer JG. Traditional health outcomes in the evaluation of diagnostic tests. Acad Radiol 1999;6:S77-80.
11. Purushotham AD, Upponi S, Klevesath MB, Bobrow L, Millar K, Myles J, et al. Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial. J Clin Oncol 2005;23:4312-21. (Pubitemid 46209968)
12. Jeetley P, Burden L, Senior R. Stress echocardiography is superior to exercise ECG in the risk stratification of patients presenting with acute chest pain with negative Troponin. Eur J Echocardiogr 2006;7:155-64. (Pubitemid 43257201)
13. Babjuk M, Soukup V, Petrík R, Jirsa M, Dvorácek J. 5-aminolaevulinic acid-induced fluorescence cystoscopy during transurethral resection reduces the risk of recurrence in stage Ta/T1 bladder cancer. BJU Int 2005;96:798-802. (Pubitemid 41391384)
14. Viney RC, Boyer MJ, King MT, Kenny PM, Pollicino CA, Mclean JM, et al. Randomized controlled trial of the role of positron emission tomography in the management of stage I and II non-small-cell lung cancer. J Clin Oncol 2004;22:2357-62. (Pubitemid 41115392)
15. Kock MC, Adriaensen ME, Pattynama PM, van Sambeek MR, van Urk H, Stijnen T, et al. DSA versus multi-detector row CT angiography in peripheral arterial disease: randomized controlled trial. Radiology 2005;237:727-37. (Pubitemid 41507918)
16. Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, et al. Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med 2001;344:1879-87. (Pubitemid 32564900)
17. Bouza E, Torres MV, Radice C, Cercenado E, de Diego R; Śnchez-Carrillo C, et al. Direct E-test (AB Biodisk) of respiratory samples improves antimicrobial use in ventilator-associated pneumonia. Clin Infect Dis 2007;44:382-7. (Pubitemid 46147621)
18. Oosterheert JJ, van Loon AM, Schuurman R, Hoepelman AI, Hak E, Thijsen S, et al. Impact of rapid detection of viral and atypical bacterial pathogens by real-time polymerase chain reaction for patients with lower respiratory tract infection. Clin Infect Dis 2005;41:1438-44. (Pubitemid 41579985)
19. McCaffery KJ, Irwig L, Turner R, Chan SF, Macaskill P, Lewicka M, et al. Psychosocial outcomes of three triage methods for the management of borderline abnormal cervical smears: an open randomised trial. BMJ 2010;340:b4491.
20. Barton MB, Morley DS, Moore S, Allen JD, Kleinman KP, Emmons KM et al. Decreasing women's anxieties after abnormal mammograms: a controlled trial. J Natl Cancer Inst 2004;96:529-38. (Pubitemid 38559577)
21. Bossuyt PMM, McCaffery K. Multiple pathways and additional patient outcomes in evaluations of testing. Med Decis Making 2009;29:E30-8.
22. Ogden J, Heinrich M, Potter C, Kent A, Jones S. The impact of viewing a hysteroscopy on a screen on the patient's experience: a randomised trial. BJOG 2009;116:286-93.
23. Goodacre SW, Nicholl J, Dixon S, Cross E, Angelini K, Arnold J, et al. Randomised controlled trial and economic evaluation of a chest pain observation unit compared with routine care. BMJ 2004;328:254-60.
24. Djais N, Kalim H. The role of lumbar spine radiography in the outcomes of patients with simple acute low back pain. APLAR J Rheumatol 2005;8:45-50. (Pubitemid 41657785)
25. Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2008;2:CD000011.
26. Summerton, N. Positive and negative factors in defensive medicine: a questionnaire study of general practitioners. BMJ 1995;310:27-9.
27. Hauser MJ, Commons ML, Bursztajn HJ, Gutheil TG. Fear of malpractice liability and its role in clinical decision making. In: Gutheil TG, Bursztajn HJ, Brodsky A, Alexander V, eds. Decision making in psychiatry and the law. 1st ed. Williams and Wilkins, 1991.
28. Hunink MGM, Krestin GP. Study design for concurrent development, assessment, and implementation of new diagnostic imaging technology. Radiology . 2002;222:604-14. (Pubitemid 34215202)
29. Moher D, Hopewell S, Schultz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.
30. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: new guidance. Medical Research Council, 2008.
31. Pennant M, Takwoingi Y, Pennant L, Davenport C, Fry-Smith A, Eisinga A, et al. A systematic review of positron emission tomography (PET) and positron emission tomography/computed tomography (PET/CT) for the diagnosis of breast cancer recurrence. Health Technol Assess 2010;14:1-103.
32. Pletcher MJ, Pignone M. Evaluating the clinical utility of a biomarker: a review of methods for estimating health impact. Circulation 2011;123:1116-24.
33. Rychetnik L, Frommer M, Hawe P, Shiell A. Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health 2002;56:119-27. (Pubitemid 34098464)
34. Deeks JJ. Assessing outcomes following tests. In: Price CP, Christenson EH, eds. Evidence-based laboratory medicine: principles, practice and outcomes. 2nd ed. AACC Press; 2007;95-111.