Abstract
ObjectiveTo identify and characterize patient-centered outcomes (PCOs) relating to multiparametric MRI (mpMRI) and MRI-guided biopsy as diagnostic tests for possible prostate cancer.MethodsMedline via OVID, EMBASE, PsycInfo, and the Cochrane Central register of Controlled Trials (CENTRAL) were searched for relevant articles. Hand searching of reference lists and snowballing techniques were performed. Studies of mpMRI and MRI-guided biopsy that measured any PCO were included. There were no restrictions placed on year of publication, language, or country for study inclusion. All database search hits were screened independently by two reviewers, and data were extracted using a standardized form.ResultsOverall, 2,762 database search hits were screened based on title and abstract. Of these, 222 full-text articles were assessed, and 10 studies met the inclusion criteria. There were 2,192 participants featured in the included studies, all of which were conducted in high-income countries. Nineteen different PCOs were measured, with a median of four PCOs per study (range 1-11). Urethral bleeding, pain, and urinary tract infection were the most common outcomes measured. In the four studies that compared mpMRI or MRI-guided biopsy to transrectal ultrasound biopsy, most adverse outcomes occurred less frequently in MRI-related tests. These four studies were assessed as having a low risk of bias.DiscussionPCOs measured in studies of mpMRI or MRI-guided biopsy thus far have mostly been physical outcomes, with some evidence that MRI tests are associated with less frequent adverse outcomes compared with transrectal ultrasound biopsy. There was very little evidence for the effect of mpMRI and MRI-guided biopsy on emotional, cognitive, social, or behavioral outcomes.
Highlights
The current diagnostic tests for prostate cancer have important limitations, which can impact patients
Prostate biopsy via the transrectal (TRUS) or transperineal route under ultrasound guidance carry a risk of adverse effects [1], and both have a significant false-negative rate leading to potential underdiagnosis [2]
MRIguided biopsy has been shown to increase the diagnostic accuracy for clinically significant prostate cancer and reduce the numbers of patients diagnosed with clinically insignificant prostate cancer [4,5]
Summary
The current diagnostic tests for prostate cancer have important limitations, which can impact patients. Diagnostic accuracy, and adverse effects are all important clinical outcomes of diagnostic tests, but they are not the only elements that need to be considered. The Agency for Healthcare Research and Quality Effective Healthcare Program White Paper series on diagnostic test evaluation proposed that, in addition to the clinical outcome, a medical test can have emotional, social, cognitive, and behavioral outcomes for patients. These outcomes can be positive or negative, and they are not restricted to the medical test itself, but the entire diagnostic pathway [6]
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