Validation Study of the Heavy Menstrual Bleeding Questionnaire in Adolescents
Authors: Pike Meghan , Chopek Ashley , Young Nancy , Usuba Koyo , Belletrutti Mark J. , McLaughlin Robyn , Van Eyk Nancy , Bouchard Amanda , Matteson Kristen , Price Victoria E. 
Published: November 2020

Introduction
Heavy menstrual bleeding (HMB) is a common problem among adolescent girls that affects many aspects of their lives. Estimating the effect of HMB on health-related quality of life (HRQoL) is important but challenging, as there is no instrument that measures menstrual bleeding-specific HRQoL for girls ages &lt; 18 years.
Aim
To develop and assess the psychometric properties of a menstrual bleeding-specific HRQoL tool adapted for use by girls with HMB aged &lt; 18 years.
Methods
HMB was defined using a pictorial bleeding assessment chart (PBAC) score &gt;100 and/or hemoglobin &gt;2 SD below age appropriate means. Phase 1 utilized a focus group of girls with HMB to review items of the Menstrual Bleeding Questionnaire (MBQ), validated for use in women ages ≥ 18 years, to generate new items and develop the Adolescent MBQ (aMBQ). In phase 2, participants were divided in two groups: those with and those without HMB. Each participant completed 3 questionnaires (aMBQ, Pediatric Quality of Life core module [PedsQL] and PBAC) at 2 time points. Validity of the aMBQ was measured by Spearman's correlation with the PedsQL. Reliability was calculated using an intra-class correlation (ICC) random effect model in those without HMB who repeated the 3 questionnaires within 30-60 days from baseline. Receiver Operating Characteristic (ROC) curve analysis assessed the ability of the aMBQ to distinguish between participants with and without HMB. Ethics approval and informed consent were obtained prior to participation.
Results
Phase 1 included 5 girls with previously diagnosed HMB. The MBQ was revised to be appropriate for adolescents by substituting 4 words/phrases that altered 8 of 20 questions (Table 1). With the addition of one new question, a 21-item aMBQ was developed with a score range of 0-77, with 77 representing the worst HRQoL. Phase 2 included 73 participants: 19 with HMB and 56 without HMB. Mean age of participants was 14.7 years (range 11-17 years). The validity of the aMBQ was confirmed by a moderate correlation with PedsQL (rho=-0.61). Test-retest reliability was substantial (ICC=0.71, p=0.03). An aMBQ score of &gt;30 identified those with HMB with excellent discrimination (AUC=0.826, sensitivity 71.4%, specificity 88.0%).
Conclusion
The aMBQ is a valid and reliable measurement tool to assess HRQoL in adolescents with HMB that is easily implemented in the office setting. Furthermore, it may assist clinicians in identifying those with HMB and aid in the evaluation of treatment effectiveness both in clinical practice and research.

Disclosures
Belletrutti: Takeda Canada: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novo Nordisk Canada: Membership on an entity's Board of Directors or advisory committees; Bayer Canada: Membership on an entity's Board of Directors or advisory committees; Roche Canada: Consultancy, Membership on an entity's Board of Directors or advisory committees; CSL Behring: Membership on an entity's Board of Directors or advisory committees. Matteson:ABOG: Honoraria, Other: Received stipend for being an oral boards examiner.; Myovant: Membership on an entity's Board of Directors or advisory committees; Bayer Ensure: Other: Co-Investigator for longitudinal research study and clinical trial. All funds go to site of research, Research Funding.