Study designs of evaluations included in the review
No inclusion criteria relating to the study design were specified.
Specific interventions included in the review
Studies of f/tPSA or cPSA as a reflex test were eligible for inclusion. All assays had to be performed using commercially available kits, and both free and total PSA had to be assayed by the same manufacturer. In addition, blood had to be sampled prior to prostate manipulation or biopsy.
Reference standard test against which the new test was compared
Studies that used histology based on a single biopsy as the reference standard were eligible for inclusion. The indication for biopsy had to be independent of the f/tPSA or cPSA test result. Biopsies were either unspecified, transrectal ultrasound (TRUS) guided sextant biopsy, more than 6 cores or repeated biopsy.
Participants included in the review
Studies of men with tPSA levels between 2 and 10 ng/mL were eligible for inclusion. The studies had to include at least 10 men with prostate cancer who were not undergoing treatment at the time of recruitment. The age of the study participants ranged from 35 to 95 years and the mean age (where reported) ranged from 59 to 73 years. Study populations were referral patients or screening patients. Indications for biopsy included elevated PSA alone, elevated PSA and/or suspicious digital rectal examination (DRE), elevated PSA and non-suspicious DRE, elevated PSA and/or suspicious DRE and/or suspicious TRUS. tPSA reflex ranges were 2 to 4 ng/mL, 2 to 10 ng/mL and 4 to 10 ng/mL.
Outcomes assessed in the review
Studies that provided data on sensitivity and specificity were eligible for inclusion.
How were decisions on the relevance of primary studies made?
The authors did not state how the papers were selected for the review, or how many reviewers performed the selection.