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How to Define Success in Prolactinoma Treatment-A Systematic Review and Theoretical Framework
Victoria R van Trigt1, Kevin A Huynh1, Leontine E H Bakker1
1Department of Medicine, Division of Endocrinology, and Center for Endocrine Tumors Leiden, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Purpose:
As consensus regarding outcome sets for prolactinoma treatment evaluation is lacking, this study evaluated outcome parameters reported in the literature, and objective, clinically relevant outcome sets were proposed.
Methods:
A systematic review of studies up to February 2, 2024. Reported biochemical and radiological parameters; clinician-reported findings; patient-reported outcomes (PROs); and definitions of disease remission, control, and recurrence were extracted and placed into a clinical context. Subsequently, objective and clinically relevant definitions of clinical outcomes were proposed based on the findings, with comprehensive outcome sets to evaluate treatment success.
Results:
One hundred thirty-seven articles were included. Albeit ill-defined or subjective, 23 unique prolactin parameters and 73 unique radiological parameters were reported. Seventy articles included clinician-reported findings, and none reported PROs. Ultimately, 27 unique definitions of remission, 3 unique definitions of disease control, and 20 unique definitions of recurrence were reported. We propose 2 separate definitions for biochemical and clinical remission/recurrence-either evaluating prolactin levels only or including symptomology, gonadal function, and radiology. Integrated outcome quadrants were illustrated to objectively categorize treatment success by combining achievement of treatment goals with the occurrence of adverse effects. A 3-tier outcome set based on the Value-Based Healthcare principles is provided.
Conclusion:
Heterogeneity in reported outcome parameters using varying definitions hampers the comparison of prolactinoma treatment outcomes. This study proposes objective, easily applicable, and clinically relevant definitions of clinical outcomes and offers a comprehensive outcome set. These parameters enable comparison of outcomes across treatment modalities and medical centers to gain insight into this rare disease and improve prolactinoma care.
