title: Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding.
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.
  
  
  CONCLUSIONS
  In this study, the MP distinguished women with HMB and adequately assessed improvements with therapy.
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA. lois.larsen@abbott.com
authors.forename: Lois
authors.initials: L
authors.lastname: Larsen
authors.forename: Karin
authors.initials: K
authors.lastname: Coyne
authors.forename: Kristof
authors.initials: K
authors.lastname: Chwalisz
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D002359:Cartoons as Topic; D004311:Double-Blind Method; D004963:Estrenes / Q000627:therapeutic use; D005260:Female; D006427:Hemin / Q000378:metabolism; D006801:Humans; D007889:Leiomyoma / Q000150:complications*; D008595:Menorrhagia / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D052576:Menstrual Hygiene Products; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D009656:North America; D010091:Oximes / Q000627:therapeutic use; D011237:Predictive Value of Tests; D017697:Premenopause; D011446:Prospective Studies; D015203:Reproducibility of Results; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000150:complications*
chemical_list: D015415:Biomarkers; D004963:Estrenes; D010091:Oximes; C488516:asoprisnil; D006427:Hemin