Evaluation of a screening tool for bleeding disorders in a US multisite cohort of women with menorrhagia




Objective


The purpose of this study was to determine the usefulness of a simple screening tool for bleeding disorders in a multisite population of women with menorrhagia.


Study Design


Women with menorrhagia between the ages of 18 and 50 years from 6 geographically diverse US centers underwent hemostatic testing for bleeding disorders, complete blood cell count, and ferritin. A questionnaire that contained all elements of the 8-question screening tool was administered. Sensitivity of the screening tool, a screening tool with a pictorial blood assessment chart (PBAC) score of >185, and a screening tool with serum ferritin were calculated for hemostatic disorders.


Results


Two hundred and seventeen women who were identified with a PBAC score of ≥100 participated in the study. The sensitivity of the screening tool was 89% for hemostatic defects, and sensitivity increased to 93% and 95% with a serum ferritin level of ≤20 ng/mL and a PBAC score of >185, respectively.


Conclusion


This study confirms the usefulness of a short screening tool for the stratification of women with menorrhagia for hemostatic evaluation.


It is estimated annually that approximately 5% of reproductive-age women seek medical attention for menorrhagia. Underlying hemostatic abnormalities, which include decreased von Willebrand factor (VWF), platelet dysfunction, and decreased coagulation factors, are found commonly in women with menorrhagia. Yet, most women with menorrhagia seek medical attention for their symptoms from gynecologists and primary care physicians, rather than from hematologists. Furthermore, few of these women are referred for hemostatic evaluation, despite the high prevalence of hemostatic abnormalities in this population ; the average delay from onset of bleeding symptoms to diagnosis of a bleeding disorder has been reported to be 16 years. Barriers to referral for hemostatic evaluation include difficulties gynecologists and primary care physicians have in determining whom to refer, lack of recognition by gynecologists and primary care physicians of menorrhagia as a symptom of a bleeding disorder, the size of the population with complaints of menorrhagia, and the lack of simple laboratory tests to screen for hemostatic abnormalities in this population. Given the under-recognition and delay in diagnosis of bleeding disorders and the potential for bleeding complications with surgery, childbirth or invasive procedures in women with menorrhagia, and unidentified bleeding disorders, a standardized screening tool to assist in the determination of which women to refer for hemostatic evaluation would be useful for the practicing gynecologist. Using data from women with menorrhagia at a single institution, a simple easy-to-administer screening tool comprised of 8 questions in 4 categories has been developed to help gynecologists assess which women with menorrhagia to refer for a comprehensive hemostatic evaluation. The purpose of the current study was to test the screening tool in a prospectively recruited US multisite population of women with menorrhagia. Additionally, we examined potential modifications to the screening tool to increase the sensitivity of the identification of women with potential bleeding disorders.


Materials and Methods


Study population


Women between the ages of 18 and 50 years at 6 centers in the United States with a physician diagnosis of menorrhagia were approached for participation. A pictorial blood assessment chart (PBAC) score of ≥100, uterine size ≤12 weeks of gestation, and an otherwise negative pelvic examination and normal Papanicolaou smear test within 1 year of participation were required for eligibility. Nonsteroidal antiinflammatory agents, aspirin, and all antiplatelet medications and herbal agents were discontinued for a minimum of 10 days before initial laboratory testing. Women who could not discontinue antiplatelet agents were excluded from participation. Women with previously diagnosed bleeding disorders and those who were on hormonal therapy that included estrogen and/or progesterone contraceptives within the last 3 months or who were using an intrauterine device or planning pregnancy were also excluded. Women with a history of malignancy, uncontrolled hypertension, insulin-dependent diabetes mellitus, chronic liver or renal disease, a seizure disorder, venous or arterial thromboembolism, and/or anticoagulation therapy or vascular disease were excluded from participation as well. This study was performed as a substudy of a US multisite menorrhagia management study. The study was approved by the institutional review boards of the respective centers and the Centers for Disease Control and Prevention. The study was explained to eligible women, and informed consent was obtained.


Four hundred twelve women were identified as eligible to participate; of these, 343 women provided informed consent; 80 women withdrew consent. Of the remaining women, 28 did not meet PBAC score criteria for menorrhagia. Among the women who underwent hemostatic testing, 3 women had incomplete laboratory testing. Analysis was performed on 217 women with complete questionnaire and laboratory data.

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Jun 21, 2017 | Posted by in GYNECOLOGY | Comments Off on Evaluation of a screening tool for bleeding disorders in a US multisite cohort of women with menorrhagia

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