What Evidence Do We Need From Objective and Subjective Outcomes in Order to Recommend Specific Operative Procedures for Men to Relieve BPO and Women With SUI? ICI-RS 2025.

AIM: Metrics used to evaluate meaningful clinical outcomes have long been a matter of controversy, particularly where there is no defined objective cure and patient-reported metrics (PROMs) are utilised as objective measures of subjective phenomena. The ICI-RS 2025 think tank discussed the relative merits of objective and subjective outcomes in clinical trials.

METHODS

A review of medical literature in four key areas; hard metrics versus PROMs assessment of Minimally Invasive Surgical Treatments for Bladder Outflow Obstruction, for Stress Urinary Incontinence, and their use in current registries and databases were debated. Limitations of trial design were highlighted and proposals for further reporting, steering groups and guidance panels suggested.

RESULTS

It is yet to be fully understood how objective data and PROMs weigh bias and variability. Longitudinal study for objective and subjective metrics is required. Qualitative study with benchmarking may allow future studies to allow patients to set their own goals and develop more nuanced, patient-defined PROMs. Databases incorporating core metrics, specialist assessments and regression analysis may have utility to create composite algorithms into unified scoring systems. Artificial intelligence learning may be applied to large datasets.

CONCLUSIONS

Both objective and subjective assessments have their limitations. A balanced approach, combining both may provide the most complete and accurate picture.