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Background: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in the study and to evaluate its generalizability.Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, methodologists and statisticians, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.Results: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both.Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public. [ABSTRACT FROM AUTHOR]

Context: Magnetic resonance angiography (MRA) is a rapidly evolving technique that has been reported to be accurate for assessment of lower extremity arterial disease.Objective: To obtain the best available estimates of the diagnostic performance of MRA in patients with lower extremity arterial disease.Data Sources: Studies published from January 1985 through May 2000 in English, German, or French, identified from the MEDLINE, EMBASE, and Current Contents databases.Study Selection: Studies were included that allowed construction of 2 x 2 contingency tables for detection of stenosis greater than 50% or occlusion with MRA or arteriography in patients with claudication or critical ischemia.Data Extraction: Two observers graded the following elements of study quality: consecutively enrolled patients, prospective study design, clear cut-off levels, blinded assessment, and clear description of MRA technique. Summary receiver operating characteristic analysis was performed to examine the influence of year of publication, all methodological criteria, arterial tract, number of subdivisions within arterial tracts, and MRA technique on diagnostic performance.Data Synthesis: Of 3583 studies initially identified, 34 were included that evaluated MRA in 1090 patients (72% men; median age, 65 years). Magnetic resonance angiography was highly accurate for assessment of all lower extremity arteries. Three-dimensional gadolinium-enhanced (3-D Gd) MRA improved diagnostic performance compared with 2-D MRA (relative diagnostic odds ratio, 2.8 [95% confidence interval, 1.2-6.4]), adjusted for number of subdivisions within arterial tracts. The estimated points of equal sensitivity and specificity were 94% and 90% for 3-D Gd MRA and 2-D MRA, respectively.Conclusions: Magnetic resonance angiography is highly accurate for assessment of the entire lower extremity for arterial disease. Three-dimensional Gd-enhanced MRA improves diagnostic performance compared with 2-D MRA. [ABSTRACT FROM AUTHOR]

Serum progesterone measurement has been advocated as a diagnostic tool in the non-invasive diagnosis of ectopic pregnancy. To assess the accuracy of a single serum progesterone measurement in the diagnosis of ectopic pregnancy, a meta-analysis was performed incorporating 26 studies evaluating the performance of single serum progesterone measurement in the diagnosis of ectopic pregnancy. A distinction was made in the diagnosis of pregnancy failure of any type versus viable intrauterine pregnancy and the diagnosis of ectopic pregnancy versus non-ectopic pregnancy. The reported sensitivity and specificity differed between the studies. Since there was a clear negative correlation between sensitivity and specificity, summary receiver-operating characteristic (ROC) curves could be estimated. The ROC curve for the diagnosis of pregnancy failure versus viable intrauterine pregnancy showed a good discriminative capacity. Single serum progesterone measurement could not discriminate between ectopic pregnancy and non-ectopic pregnancy. It is concluded that serum progesterone measurement can identify patients at risk for ectopic pregnancy, who need further evaluation, but its discriminative capacity is insufficient to diagnose ectopic pregnancy with certainty. [ABSTRACT FROM AUTHOR]