The impact of targeted training, a dedicated protocol and on‐site training material in reducing observer variability of prostate and transition zone dimensions measured by transrectal ultrasonography, in multicentre multinational clinical trials of men with symptomatic benign prostatic enlargement

Abstract

methods, which was supplemented at the outset by a compact disc-based video. RESULTSThe mean ( SD ) changes from baseline in TPV at 13 and 26 weeks were − 2.9 (8.9) and − 1.9 (8.5) mL, respectively; the respective mean changes from baseline in TZV were − 1.2 (6.4) and + 0.7 (7.8) mL. For TPV, 80% of the measurements had differences of + 5.2 to − 13.4 mL at 13 weeks, and + 8.0 to − 10.9 mL at 26 weeks. For TZV, 80% of the differences were + 5.8 to − 7.4 at 13 weeks, and + 9.3 to − 6.5 mL at 26 weeks. CONCLUSIONThe performance of TRUS compared favourably with similar published multicentre studies, which we suggest relates in part to the careful implementation of the protocol. We showed that diligent implementation of a detailed protocol, supplemented by targeted training of investigators and provision of onsite training material, promoted consistent acquisition and successful derivation of key clinical trial endpoints. Quantifying the variability of such endpoints will enable us to track deployment quality for future clinical trials, and will ensure that trials are sufficiently powered to define small changes in prostate size.