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Validation of the Menstrual Pictogram in Women With Leiomyomata Associated With Heavy Menstrual Bleeding

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Abstract

Objective

The menstrual pictogram (MP), a semiquantitative, easy-to-use tool to assess blood loss, was validated against the reference standard of alkaline hematin (AH) quantitation using data pooled from 3 clinical trials.

Methods

Premenopausal women aged ≥18 years with heavy menstrual bleeding (HMB) associated with uterine leiomyomata were randomized to asoprisnil (10 or 25 mg) or placebo. Patients completed the MP and collected feminine hygiene products for assessment of blood loss by the AH method. Agreement between the MP and the AH method was calculated.

Results

The positive predictive value of the MP total to distinguish women with HMB against the AH total was 91%. The agreement (κ-statistic) between AH and MP totals for classifying patients with ≥50% or <50% decreases in HMB was 0.88 (95% confidence interval [CI], 0.78-0.98), and the MP was 96% sensitive and 92% specific. The methods showed good association for percentage change in blood (intraclass correlation coefficient [ICC] of 0.86, 95% CI, 0.80-0.91) but not for actual blood loss per cycle (ICC of 0.64, [95% CI, 0.55-0.71]); the greatest underestimation occurred for severely stained napkins.

Conclusion

In this study, the MP distinguished women with HMB and adequately assessed improvements with therapy.

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Authors and Affiliations

  1. Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL, 60064, USA

    Lois Larsen PhD & Kristof Chwalisz MD, PhD

  2. United BioSource Corporation, Bethesda, MD, USA

    Karin Coyne MPH, PhD

Authors
  1. Lois Larsen PhD
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  2. Karin Coyne MPH, PhD
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  3. Kristof Chwalisz MD, PhD
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Correspondence to Lois Larsen PhD.

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Larsen, L., Coyne, K. & Chwalisz, K. Validation of the Menstrual Pictogram in Women With Leiomyomata Associated With Heavy Menstrual Bleeding. Reprod. Sci. 20, 680–687 (2013). https://doi.org/10.1177/1933719112463252

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