The architecture of diagnostic research: From bench to bedside-research guidelines using liver stiffness as an example

Hepatology

Volumn 60, Issue 1, 2014, Pages 408-418

  Colli, Agostino ^a,b   Fraquelli, Mirella ^a   Casazza, Giovanni ^a,c   Conte, Dario ^a   Nikolova, Dimitrinka ^a   Duca, Piergiorgio ^c   Thorlund, Kristian ^a,d   Gluud, Christian ^a  

^a UNIVERSITY OF MILAN   (Italy)

^b A MANZONI HOSPITAL   (Italy)

^c UNIVERSITY OF MILAN   (Italy)

^d MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL RESEARCH; COHORT ANALYSIS; COMPARATIVE STUDY; DIAGNOSTIC ACCURACY; ELASTOGRAPHY; HUMAN; LIVER DISEASE; LIVER FIBROSIS; LIVER STIFFNESS; NORMAL VALUE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; REFERENCE VALUE; RELIABILITY; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STUDY DESIGN; SYSTEMATIC REVIEW; VALIDITY;

ANIMALS; CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; ELASTICITY IMAGING TECHNIQUES; GASTROENTEROLOGY; HUMANS; LIVER DISEASES; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84903211610     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.26948     Document Type: Article

References (26)

1. Feinstein AR. Clinical Epidemiology. The architecture of Clinical Research. Philadelphia: WB Saunders; 1985.
2. Sackett D, Haynes RB. The architecture of diagnostic research. BMJ 2002;324:539-541.
3. Gluud C, Gluud LL. Evidence based diagnostics. BMJ 2005;330:724-726.
4. Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, et al. Phase of biomarker development for early detection of cancer. J Natl Cancer Inst 2001;93:1054-1061.
5. Carmel R, Agrawal YP. Failures of cobalamin assays in pernicious anemia. N Engl J Med 2012;367:385-386.
6. Sandrin L, Tanter M, Gennisson JL, Catheline S, Fink M. Shear elasticity probe for soft tissues with 1-D transient elastography. IEEE Trans Ultrason Ferroelectr Freq Control 2002;49:436-446.
7. Sandrin L, Fourquet B, Hasquenoph JM, Yon S, Fournier C, Mal F, et al. Transient elastography: a new non-invasive method for assessment of hepatic fibrosis. Ultrasound Med Biol 2003;29:1705-1713.
8. Corpechot C, El Naggar A, Poujol-Robert A, Ziol M, Wendum D, Chazouillères O, et al. Assessment of biliary fibrosis by transient elastography in patients with PBC and PSC. Hepatology 2006;43:1118-1124.
9. Roulot D, Czernichow S, Le Clésiau H, Costes JL, Vergnaud AC, Beaugrand M. Liver stiffness values in apparently healthy subjects: influence of gender and metabolic syndrome. J Hepatol 2008;48:606-613.
10. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al.;Standards for Reporting of Diagnostic Accuracy. Toward complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Ann Intern Med 2003:138:40-44.
11. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 (updated February 2008). The Cochrane Collaboration, 2008. Available from http://www.cochrane.org/resources/handbook.
12. Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al.;QUADAS-2 Group. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med 2011;155:529-536.
13. Ganne-Carrié N, Ziol M, de Ledinghen V, Douvin C, Marcellin P, Castera L, et al. Accuracy of liver stiffness measurement for the diagnosis of cirrhosis in patients with chronic liver diseases. Hepatology 2006;44:1511-1517.
14. Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology 2008;134:960-974.
15. Marrero JA, Su GL, Wei W, Emick D, Conjeevaram HS, Fontana RJ, Lok AS. Des-gamma carboxyprothrombin can differentiate hepatocellular carcinoma from nonmalignant chronic liver disease in American patients. Hepatology 2003;37:1114-1121.
16. Colli A, Pozzoni P, Berzuini A, Gerosa A, Canovi C, Molteni EE, et al. Decompensated chronic heart failure: increased liver stiffness measured by means of transient elastography. Radiology 2010;257:872-878.
17. Sagir A, Erhardt A, Schmitt M, Häussinger D. Transient elastography is unreliable for detection of cirrhosis in patients with acute liver damage. Hepatology 2008;47:592-595.
18. Colombo M, Del Ninno E, de Franchis R, De Fazio C, Festorazzi S, Ronchi G, Tommasini MA. Ultrasound-assisted percutaneous liver biopsy: superiority of the Tru-Cut over the Menghini needle for diagnosis of cirrhosis. Gastroenterology 1988;95:487-489.
19. Ferrante di Ruffano L, Hyde CJ, McCaffery KJ, Bossuyt PM, Deeks JJ. Assessing the value of diagnostic tests: a framework for designing and evaluating trials. BMJ 2012;344:e686.
20. Bossuyt PM, Irwig L, Craig J, Glasziou P. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ 2006;332:1089-1092.
21. Croswell JM, Baker SG, Marcus PM, Clapp JD, Kramer BS. Cumulative incidence of false-positive test results in lung cancer screening: a randomized trial. Ann Intern Med 2010;152:505-512, W176-W180.
22. Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet 2004;363:600-607.
23. Briel M, Schuetz P, Mueller B, Young J, Schild U, Nusbaumer C, et al. Procalcitonin guided antibiotic use vs a standard approach for acute respiratory tract infections in primary care. Arch Intern Med 2008;168:2000-2007.
24. Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr T, Andersen MH, et al. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial. Crit Care Med 2011;39:2048-2058.
25. Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, et al. Non-invasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology 2011;140:1970-1979.
26. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008;61:64-75.