Search

The objective of the 'Standards for Reporting of Diagnostic Accuracy' (STARD) initiative is to improve the reporting of studies of diagnostic accuracy, so as to allow readers to assess the potential for bias in a study and to evaluate the generalibility of its results. The group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies. This was used to draw up a list of potential items. During a consensus meeting, a group of researchers, medical journal editors, and members of professional organisations reduced this list to a usable checklist. Wherever possible, evidence from the literature was used to justify the decisions made. The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which a list of 75 potential items was extracted. At the consensus meeting, participants shortened the list to a 25-item checklist. A generic flow diagram was drawn up to provide guidance on the method for including patients, the order in which tests were to be conducted and the number of patients to undergo the test being evaluated, the reference standard, or both. A scientific publication can only be assessed when the reporting is both correct and complete. Use of the checklist and flow diagram will improve the quality of reports produced, to the advantage of clinicians, researchers, reviewers, journal editors and other interested parties.

Objective: Evaluation of the diagnostic accuracy of ultrasound in the second trimester for the detection of spina bifida., Design: Systematic review and meta-analysis., Method: Medline and Embase were searched to identify prospective studies in a general pregnant population. Also, in the Cochrane Library, references of identified reports and recent reviews were checked for relevant studies. Retrieved abstracts were selected independently by 2 authors using predefined criteria. Assessment of quality and generalizability of the included studies and data extraction were performed by 3 authors independently. The data were tested for heterogeneity and pooled estimates of sensitivity and specificity were calculated for all studies., Results: 13 studies were included. Specificity was approximately 100% in all cases. Sensitivity varied from 40% to 100%. The summary point estimate for sensitivity was 71% with a 95% confidence interval of 59%-81%., Conclusion: Ultrasound in the second trimester is a specific investigation to detect spina bifida, which may detect seven out of ten defects. Used as a screening tool, it could contribute to a significant reduction in the number of children born with spina bifida.

In this era of evidence-based medicine, diagnostic tests cannot escape close scrutiny of their effectiveness. Sensitivity and specificity have up till now played a central role in the evaluation of diagnostic tests. These terms are not without their shortcomings when it comes to the characterisation of a test's true worth for patients. Randomised clinical trials are increasingly used for evaluation of medical tests and outlining of strategy. The indirect relationship between test results and health outcome creates additional challenges for designers of such trials.