Abstract
BackgroundPictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care.MethodsA literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB.ResultsNine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58–97%, the specificity was 7.5–95.5%, the positive and negative likelihood ratios were 1.1–13.8 and 0.14–0.56, respectively, and the diagnostic odds ratio was 2.6–52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures.ConclusionsPBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care.Review registration numberPROSPERO international prospective register of systematic reviews: CRD42016030083.
Highlights
Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials
With one exception (Magnay et al 2014 [5]), it was unclear whether PBAC test scores were interpreted without knowledge of alkaline hematin (AH) results, and vice versa
The pooled population from these reports comprised 1347 women with a wide spectrum of MBL levels. This corresponded to 1821 menstrual cycles for which AH data and self-assessed PBAC scores were available
Summary
Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care. HMB is defined as a measured menstrual blood loss (MBL) of > 80 mL per cycle, but studies have repeatedly shown that at least 40% of women seeking medical attention for heavy periods lose less than this volume [2–5]. Many clinical trial protocols require treatment efficacy for HMB to be determined by quantitative changes in MBL before a license can be granted for a new drug or surgical procedure. It is mainly confined to clinical trials and the research setting to confirm or refute HMB and to evaluate efficacy of medical or surgical treatments
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