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How sound are diagnostic studies in China? Implications of diagnostic studies on dot-immunogold filtration assay to diagnose tuberculosis

Date: Poster sessions
Source: Forum 11
Authors: Li Jing, Vice-Director, Evidence-based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, People's Republic of China
with Xia Liu, Changlin Ai Changlin, Yuanxun Zhao and Youping Li


Dot-immunogold filtration assay (DIGFA) is widely used in the diagnosis of tuberculosis (TB) in China. This study aims to assess how valid and reliable the information provided by diagnostic studies is in China by assessing the quality of the tuberculosis antibody detection.

The VIP (WEB) database (2000­2006) was searched; any diagnostic studies that used DIGFA to detect the TB antibody were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS) was used to assess the quality of included diagnostic studies, using two independent researchers.

Thirty-eight papers were included and assessed. We found that most quality criteria were not met. Most papers adopted a retrospective diagnostic case-control design. Thirty one papers did not describe the selection criteria clearly, 18 did not describe whether all included patients were verified using a reference standard of diagnosis, 36 did not describe whether index test results were interpreted without knowledge of the results of the reference standard, 37 did not report uninterpretable/intermediate test results, and 34 did not report withdrawals from the study.

There are few high quality studies on the use of DIGFA in detecting tuberculosis antibodies to diagnose TB.

China is facing great challenges in its health care reform because of its large population, changes in disease spectrum and some newly emerging problems in its health service system. On the one hand, the demand for health care is rapidly increasing, and on the other limited health resources are inadequately managed; characterized by poor allocation and inefficient use. Endlessly emerging diagnostic technologies can increase health costs and may have adverse effects, despite some obvious benefits.

Understanding the value of diagnostic techniques can help physicians to make appropriate and rational selections. Therefore, the quality of diagnostic studies is very important in providing valid information. Our assessment concludes that there is a lot of room for improving the quality if diagnostic studies and strengthening research capacity.