Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

Abstract

Background: 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.

Methods: A 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.

Results: Nine 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.

Conclusions: PBACs 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 number: PROSPERO international prospective register of systematic reviews: CRD42016030083.

Keywords: Abnormal uterine bleeding; Alkaline hematin; Bleeding disorders; Endometriosis; Heavy menstrual bleeding; Menstrual blood loss; Menstrual pictogram; Pictorial blood loss assessment chart; Uterine fibroids.

Fig. 1

Database search and selection process. ^aAdditional references to those previously identified

Fig. 2

Examples of validated PBACs reported in the literature. PBAC pictorial blood loss assessment chart. a. The PBAC presented by Higham et al. reproduced from British Journal of Obstetrics and Gynaecology, 97, Higham JM et al. Assessment of menstrual blood loss using a pictorial chart, pp734–9, Copyright 2005, with permission from John Wiley and Sons [29]. b. The chart presented by Janssen et al. Adapted from Obstetrics & Gynecology, 85, Janssen CA et al. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss, pp977–82, Copyright 1995, with permission from Elsevier [31]. c. The pictorial chart presented by Barr et al. Reproduced from International Journal of Gynecology & Obstetrics, 66, Barr F et al. A pictorial chart for managing common menstrual disorders in Nigerian adolescents, pp51–3, Copyright 1999, with permission from John Wiley and Sons [32]. d. The menstrual pictogram presented by Wyatt et al. Reprinted from Fertility and Sterility, 76, Wyatt KM et al., Determination of total menstrual blood loss, pp125–33, Copyright 2001, with permission from Elsevier; and adapted from Obstetrician & Gynaecologist, 6, Warrilow G et al. Quantification of menstrual blood loss, pp88–92, Copyright 2004 Royal College of Obstetricians and Gynaecologists, with permission from John Wiley and Sons [34, 37]. e. The chart presented by Magnay et al. Reprinted from Fertility and Sterility, 101, Magnay JL et al. Validation of a new menstrual pictogram (superabsorbent polymer-c version) for use with ultraslim towels that contain superabsorbent polymers, pp515–22, Copyright 2014, with permission from Elsevier [5]

Fig 3.

Median percentage blood fraction of menstrual fluid versus icon category of menstrual pictogram (SAP-c version). Second-order polynomial curve fit of median percentage blood fraction of menstrual discharge, with respect to icon category of the menstrual pictogram (SAP-c version); n = 3257 Always Ultra sanitary towels. PBAC pictorial blood loss assessment chart, SAP-c superabsorbent-polymer-containing. Reprinted from Fertility and Sterility, 101, Magnay JL et al., Validation of a new menstrual pictogram (superabsorbent polymer-c version) for use with ultraslim towels that contain superabsorbent polymers pp515–22, Copyright 2014, with permission from Elsevier [5].

Fig. 4.

Measured blood volumes compared with the menstrual pictogram scores. Known volumes of blood were applied to Kotex Regular maxi towels to produce similar stain sizes to those depicted by the highlighted icon scores on the menstrual pictogram of Wyatt et al., which was validated using an older, obsolete version of the same sanitary product. The difference in volume required and the effect of towel compression on stain area are shown. MP menstrual pictogram. Reprinted from a poster with permission from the author: Burnett PE et al., Comparison of Menstrual Pictogram Scoring to the Validated Alkaline Hematin Assay as Techniques for Measuring Blood Loss on Feminine Hygiene Products [75]

Fig. 5

Examples of menstrual tampon shapes after addition of fluid. Anti-leak features of each tampon type are shown. When wet, o.b. ProComfort tampons swell radially to form a barrel shape, Tampax Cardboard tampons enlarge axially with minimal radial expansion and Tampax Pearl tampons expand to produce a winged profile. o.b. ProComfort tampons, Edgewell Personal Care, St Louis, MO, USA; Tampax tampons, Proctor & Gamble, Cincinnati, OH, USA

Fig. 6

Examples of PBAC clot scoring icons. Actual-size diameters shown (cm) [29, 37, 52, 54, 88]. PBAC pictorial blood loss assessment chart. Clot scoring adapted from Obstetrician & Gynaecologist, 6, Warrilow G et al., Quantification of menstrual blood loss, pp88–92, Copyright 2004 Royal College of Obstetricians and Gynaecologists, with permission from John Wiley and Sons