Page 20 - EVALUATION OF TREATMENT FOR HEAVY MENSTRUAL BLEEDING by Herman, Malou

Chapter 7
Abstract
Objective: The Pictorial Blood Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the impact of its score and its effect on outcome could have implications for using the PBAC as an outcome measurement in future HMB studies and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success of a treatment for heavy menstrual bleeding.
Design: Individual patient data (IPD) of randomised controlled trials studying women with heavy menstrual bleeding.
Method: We included studies if they had studied second generation endometrial ablation techniques and had collected PBAC scores for both baseline and follow- up. The effectiveness of treatment was scored as satisfaction or re-intervention (yes/no) 12 months after treatment. We related these outcomes to the PBAC score at 12 months after treatment and to PBAC decrease between baseline and 12 months of follow-up.
Results: We studied data of 900 patients included in 9 studies. The median PBAC score at 12 months was 7 (0-2500). The overall satisfaction rate was 89% and the overall re-intervention rate was 7.2%. A clear association was found between the PBAC at 12 months follow-up and satisfaction (odds ratio(OR) 0.16, 95% confidence interval (CI) [0.11-0.24]) and surgical re-intervention (OR 2.3, 95% CI [1.8-2.8]). PBAC decrease was also associated with satisfaction (OR 2.0, 95%CI [1.7- 2.3]) and surgical re-intervention (OR 0.69, 95%CI [0.63-0.75]). PBAC-scores at 12 months that corresponded best with satisfaction occurred at 59 points (sensitivity 77%, specificity 88%) or a decrease of around 90% in PBAC score. The best PBAC score for re-intervention occurred at 98 points (sensitivity 84%, specificity 84%) or a decrease of 75% in score.
Conclusion: PBAC scores 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as primary endpoint in studies on HMB and in clinical practice as a measure to assess the effectiveness of treatment.
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