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

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          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.

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          Most cited references99

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          Variation of a test's sensitivity and specificity with disease prevalence.

          Anecdotal evidence suggests that the sensitivity and specificity of a diagnostic test may vary with disease prevalence. Our objective was to investigate the associations between disease prevalence and test sensitivity and specificity using studies of diagnostic accuracy. We used data from 23 meta-analyses, each of which included 10-39 studies (416 total). The median prevalence per review ranged from 1% to 77%. We evaluated the effects of prevalence on sensitivity and specificity using a bivariate random-effects model for each meta-analysis, with prevalence as a covariate. We estimated the overall effect of prevalence by pooling the effects using the inverse variance method. Within a given review, a change in prevalence from the lowest to highest value resulted in a corresponding change in sensitivity or specificity from 0 to 40 percentage points. This effect was statistically significant (p < 0.05) for either sensitivity or specificity in 8 meta-analyses (35%). Overall, specificity tended to be lower with higher disease prevalence; there was no such systematic effect for sensitivity. The sensitivity and specificity of a test often vary with disease prevalence; this effect is likely to be the result of mechanisms, such as patient spectrum, that affect prevalence, sensitivity and specificity. Because it may be difficult to identify such mechanisms, clinicians should use prevalence as a guide when selecting studies that most closely match their situation.
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            Assessment of menstrual blood loss using a pictorial chart.

            Objective menstrual blood loss measurements (in ml) were compared with the score obtained from a pictorial blood loss assessment chart (PBAC) which took into account the degree to which each item of sanitary protection was soiled with blood as well as the total number of pads or tampons used. Twenty eight women used the chart during 55 menstrual cycles and a single observer assessed 122 cycle collections in a similar manner. A pictorial chart score of 100 or more, when used as a diagnostic test for menorrhagia, was found to have a specificity and sensitivity of greater than 80%. Demonstration of the relation between self assessed pictorial chart scores and the objective measurement of blood loss enables us to provide a simple, cheap and reasonably accurate method of assessing blood loss before embarking upon treatment.
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              Determination of Menstrual Blood Loss

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                Author and article information

                Contributors
                jlmagnay@aldaron.plus.com
                pmsob@me.com
                christoph.gerlinger@bayer.com
                christian.seitz@bayer.com
                Journal
                BMC Womens Health
                BMC Womens Health
                BMC Women's Health
                BioMed Central (London )
                1472-6874
                10 February 2020
                10 February 2020
                2020
                : 20
                : 24
                Affiliations
                [1 ]Institute for Science and Technology in Medicine, Guy Hilton Research Centre, Hartshill, Stoke-on-Trent, UK
                [2 ]GRID grid.9757.c, ISNI 0000 0004 0415 6205, Department of Obstetrics & Gynaecology, , Keele University School of Medicine, ; Stoke-on-Trent, UK
                [3 ]GRID grid.420044.6, ISNI 0000 0004 0374 4101, Bayer AG, ; Building P300, 13342 Berlin, Germany
                [4 ]GRID grid.11749.3a, ISNI 0000 0001 2167 7588, Gynaecology, Obstetrics and Reproductive Medicine, , University of Saarland Medical School, ; Homburg, Saar Germany
                Author information
                http://orcid.org/0000-0003-2315-9148
                Article
                887
                10.1186/s12905-020-0887-y
                7011238
                32041594
                d6ef2078-7963-4246-8667-fce14362ad76
                © The Author(s). 2020

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 8 April 2019
                : 16 January 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004326, Bayer;
                Award ID: NA
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2020

                Obstetrics & Gynecology
                menstrual blood loss,pictorial blood loss assessment chart,alkaline hematin,heavy menstrual bleeding,menstrual pictogram,abnormal uterine bleeding,bleeding disorders,uterine fibroids,endometriosis

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