Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life
- 3 November 2010
- journal article
- research article
- Published by Taylor & Francis in Current Medical Research and Opinion
- Vol. 26 (12), 2745-2755
- https://doi.org/10.1185/03007995.2010.532200
Abstract
Menorrhagia, or heavy menstrual bleeding (HMB), has a negative impact on women's quality of life (QOL). The objective was to develop, validate, and assess the performance of a disease-specific patient-reported outcome (PRO) measurement instrument for HMB (the Menorrhagia Impact Questionnaire [MIQ]). The MIQ was designed to measure the effect of HMB on a woman's self-assessment of menstrual blood loss (MBL), limitations in social/leisure activities, physical activities, and ability to work. Meaningfulness of these observed MBL changes were also measured. The development and psychometric validation of the MIQ was performed utilizing data from a long-term safety study of tranexamic acid (Lysteda * *Lysteda is a registered trade name of Ferring Pharmaceuticals Inc., Parsippany, NJ, USA. ), with comparison to an age-matched normal control group recruited from the general population. Performance of the MIQ was also evaluated using data from a six-cycle, randomized, double-blind, clinical study of tranexamic acid for the treatment of HMB. Correlations and sensitivity of each pertinent MIQ item to the treatment-induced changes in MBL were assessed, and the minimally important differences (MID) for the individual MIQ items were determined. The psychometric properties of the MIQ were fully validated. Correlations between individual MIQ items and changes in MBL were statistically significant (p < 0.001). A clear differentiation between tranexamic acid and placebo groups confirmed sensitivity of the MIQ and its ability to detect treatment-induced changes in MBL. MIDs were estimated for the individual MIQ items, with sensitivities and specificities in the 64-79% and 63-82% ranges using receiver operating characteristic (ROC) curve analyses, respectively. MIDs were found to be equal to or greater than 0.5. Statistically significant treatment differences were also observed for the proportions of subjects achieving at least 1-point improvement in MIQ scores. The MIQ contains validated constructs important to women with HMB. NCT00113568 and NCT00386308 (ClinicalTrials.gov ID).Keywords
This publication has 22 references indexed in Scilit:
- Questioning Our Questions: Do Frequently Asked Questions Adequately Cover the Aspects of Women's Lives Most Affected by Abnormal Uterine Bleeding? Opinions of Women with Abnormal Uterine Bleeding Participating in Focus Group DiscussionsWomen & Health, 2010
- Limited role of multi-attribute utility scale and SF-36 in predicting management outcome of heavy menstrual bleedingEuropean Journal of Obstetrics & Gynecology and Reproductive Biology, 2010
- Menorrhagia II: is the 80-mL blood loss criterion useful in management of complaint of menorrhagia?American Journal of Obstetrics and Gynecology, 2004
- Treatments for heavy menstrual bleedingBMJ, 2003
- Perceptions of women on the impact of menorrhagia on their health using multi‐attribute utility assessmentBJOG: An International Journal of Obstetrics and Gynaecology, 1998
- Development and validation of the menorrhagia outcomes questionnaireBJOG: An International Journal of Obstetrics and Gynaecology, 1998
- Making sense of ambiguity: evaluation in internal reliability and face validity of the SF 36 questionnaire in women presenting with menorrhagia.Quality and Safety in Health Care, 1996
- Assessment of patients with menorrhagia: How valid is a structured clinical history as a measure of health status?Quality of Life Research, 1995
- MEASUREMENT OF MENSTRUAL BLOOD LOSS IN PATIENTS COMPLAINING OF MENORRHAGIABJOG: An International Journal of Obstetrics and Gynaecology, 1977
- The Development of a Menstrual Distress QuestionnairePsychosomatic Medicine, 1968