Introduction: For clinicians it is important to know the accuracy of diagnostic tests. Systematic reviews on the diagnostic value of specific tests are rare. We performed such a review for DRE and prostate cancer, with emphasis on the methodological characteristics of the studies.

Objective: To examine the influence of methodological characteristics on the outcome of diagnostic studies.

Methods: We collected studies on DRE and prostatic cancer, published between 1983 and 1996. We searched in MEDLINE and FAMILY using a broad set of MESH terms, and checked the references of the retrieved papers. Inclusion criteria were: study population included both cases and noncases and language was English, French, German, Dutch, Spanish or Italian. Methodological quality of the papers was assessed using the critera forwarded by the Cochrane Methods Group on Meta-analysis of diagnostic and screening tests.

Results: We found 47 eligible studies. Pooled sensitivity and specificity and positive predictive value will be presented for different settings. The influence of the following methodological characteristics will be assessed: valid reference standard, independent measurement of diagnostic test and reference standard, avoidance of verification bias, withdrawals.

Discussion: Results will be discussed against the background of improvement of methodological quality of diagnostic studies.