M C Herman1, N Mak1, P M Geomini1, B Winkens2, B W Mol3, M Y Bongers1,4. 1. Department of Obstetrics & Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands. 2. Department of Methodology and Statistics, School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, the Netherlands. 3. The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia. 4. Department of Obstetrics & Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Abstract
OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with 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 after endometrial ablation for HMB. DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB. SETTING: Women with HMB consulting their gynecologists. POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB. METHODS: 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 for 900 patients included in nine 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 absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score 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). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes. CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment. TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.
OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with 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 after endometrial ablation for HMB. DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB. SETTING: Women with HMB consulting their gynecologists. POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB. METHODS: 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 for 900 patients included in nine 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 absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score 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). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes. CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment. TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.
Authors: Eva N Hamulyák; Hanke M G Wiegers; Luuk J J Scheres; Barbara A Hutten; Maria E de Lange; Anne Timmermans; Peter E Westerweel; Marten R Nijziel; Marieke J H A Kruip; Marije Ten Wolde; Paula F Ypma; Frederikus A Klok; Laurens Nieuwenhuizen; Sanne van Wissen; Marcel M C Hovens; Laura M Faber; Pieter W Kamphuisen; Harry R Büller; Saskia Middeldorp Journal: Res Pract Thromb Haemost Date: 2020-12-18
Authors: T Bourne; C Kyriacou; A Coomarasamy; M Al-Memar; M Leonardi; E Kirk; C Landolfo; M Blanchette-Porter; R Small; G Condous; D Timmerman Journal: Ultrasound Obstet Gynecol Date: 2020-06 Impact factor: 8.678