With the ascendancy of """"""""evidence-based medicine,"""""""" much attention has been paid to the quality of the evidence, with randomized controlled tdals (RCTs) considered the """"""""gold standard"""""""" against which all other types of studies are compared. There are, however, numerous clinical areas where the initial evidence is provided by observational studies such as prospective cohort and case-control studies, and only later confirmed or refuted by a randomized trial. We plan to examine these topics, and look specifically at predictors of the """"""""best"""""""" answer among the observational studies. Specifically, we hypothesize that a priod identification of biases in an observational study will be related to systematic differences in its results. As a further step, we intend to establish the directionality and potential magnitude of the biases by comparing the results of observational studies to the results of """"""""gold standard"""""""" RCTs performed on the same clinical topic. We will use meta-analyses of observational studies to identify topics where a large number of observational studies exist (often with some degree of heterogeneity), and compile information on the potential types of bias present in each study. To date, over 20 such areas with numerous observational studies and a gold standard RCT on the same clinical topic have been identified. Our research could identify potential deficiencies in the available data for a given area and guide future investigators on what common pitfalls to avoid when conducting original research in that field.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Postdoctoral Individual National Research Service Award (F32)
Project #
7F32HL074478-02
Application #
6793802
Study Section
Social Sciences, Nursing, Epidemiology and Methods 4 (SNEM)
Program Officer
Bookman, Ebony B
Project Start
2003-07-01
Project End
2004-06-30
Budget Start
2003-07-01
Budget End
2004-06-30
Support Year
2
Fiscal Year
2003
Total Cost
$51,904
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
Shah, Nirav R; Jones, J B; Aperi, Jaclyn et al. (2008) Selective serotonin reuptake inhibitors for premenstrual syndrome and premenstrual dysphoric disorder: a meta-analysis. Obstet Gynecol 111:1175-82
Blecker, Saul; Shah, Nirav R (2007) Angiotensin and renal disease: the jury is still out. Am J Kidney Dis 49:497;author reply 497
Kassai, Behrouz; Sonie, Sandrine; Shah, Nirav R et al. (2006) Literature search parameters marginally improved the pooled estimate accuracy for ultrasound in detecting deep venous thrombosis. J Clin Epidemiol 59:710-4
Shah, Nirav R; Wong, Tanping (2006) Current breast cancer risks of hormone replacement therapy in postmenopausal women. Expert Opin Pharmacother 7:2455-63
Shah, Nirav R; Noble, Paul; Jackson, Robert M et al. (2005) A critical assessment of treatment options for idiopathic pulmonary fibrosis. Sarcoidosis Vasc Diffuse Lung Dis 22:167-74
Kassai, Behrouz; Shah, Nirav R; Leizorovicza, Alain et al. (2005) The true treatment benefit is unpredictable in clinical trials using surrogate outcome measured with diagnostic tests. J Clin Epidemiol 58:1042-51
Shah, Nirav R; Borenstein, Jeff; Dubois, Robert W (2005) Postmenopausal hormone therapy and breast cancer: a systematic review and meta-analysis. Menopause 12:668-78
Kassai, Behrouz; Boissel, Jean-Pierre; Cucherat, Michel et al. (2004) A systematic review of the accuracy of ultrasound in the diagnosis of deep venous thrombosis in asymptomatic patients. Thromb Haemost 91:655-66
Shah, N R; Bracken, M B (2000) A systematic review and meta-analysis of prospective studies on the association between maternal cigarette smoking and preterm delivery. Am J Obstet Gynecol 182:465-72
Concato, J; Shah, N; Horwitz, R I (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887-92