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A systematic review of methods to measure menstrual blood loss.

ABSTRACT: BACKGROUND:Since the publication over 50 years ago of the alkaline hematin method for quantifying menstrual blood loss (MBL) many new approaches have been developed to assess MBL. The aim of this systematic review is to determine for methods of measuring MBL: ability to distinguish between normal and heavy menstrual bleeding (HMB); practicalities and limitations in the research setting; and suitability for diagnosing HMB in routine clinical practice. METHODS:Embase®™, MEDLINE®, and ClinicalTrials.gov were screened for studies on the development/validation of MBL assessment methods in women with self-perceived HMB, actual HMB or uterine fibroids, or patients undergoing treatment for HMB. Studies using simulated menstrual fluid and those that included women with normal MBL as controls were also eligible for inclusion. Extracted data included study population, results of validation, and advantages/disadvantages of the technique. RESULTS:Seventy-one studies fulfilled the inclusion criteria. The sensitivity and/or specificity of diagnosing HMB were calculated in 16 studies of methods involving self-perception of MBL (11 pictorial), and in one analysis of the menstrual-fluid-loss (MFL) method; in 13 of these studies the comparator was the gold standard alkaline hematin technique. Sensitivity and specificity values by method were, respectively: MFL model, 89, 98%; pictorial blood loss assessment chart (PBAC), 58-99%, 7.5-89%; menstrual pictogram, 82-96%, 88-94%; models/questionnaires, 59-87%, 62-86%, and complaint of HMB, 74, 74%. The power of methods to identify HMB was also assessed using other analyses such as comparison of average measurements: statistical significance was reported for the PBAC, MFL, subjective complaint, and six questionnaires. In addition, PBAC scores, menstrual pictogram volumes, MFL, pad/tampon count, iron loss, and output from three questionnaires correlated significantly with values from a reference method in at least one study. In general, pictorial methods have been more comprehensively validated than questionnaires and models. CONCLUSIONS:Every method to assess MBL has limitations. Pictorial methods strike a good balance between ease of use and validated accuracy of MBL determination, and could complement assessment of HMB using quality of life (QoL) in the clinical and research setting. TRIAL REGISTRATION:PRISMA registration number: CRD42016032956 .

SUBMITTER: Magnay JL

PROVIDER: S-EPMC6106944 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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A systematic review of methods to measure menstrual blood loss.

Magnay Julia L JL O'Brien Shaughn S Gerlinger Christoph C Seitz Christian C

BMC women's health 20180822 1

<h4>Background</h4>Since the publication over 50 years ago of the alkaline hematin method for quantifying menstrual blood loss (MBL) many new approaches have been developed to assess MBL. The aim of this systematic review is to determine for methods of measuring MBL: ability to distinguish between normal and heavy menstrual bleeding (HMB); practicalities and limitations in the research setting; and suitability for diagnosing HMB in routine clinical practice.<h4>Methods</h4>Embase®™, MEDLINE®, an ...[more]

PMID: 30134884

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Project description:BACKGROUND: Abnormal uterine bleeding is often investigated in clinical studies and critical to identify during gynecological consultation. The current standard for quantification of menstrual blood loss is the alkaline-hematin-method. However, this method is expensive and inconvenient for patients. Bleeding diaries, although widely used, provide only qualitative information on menstrual blood loss. Other methods have been developed, but still do not provide reliable quantitative data. METHODS: We estimated blood loss volume using data from two clinical studies in women suffering abnormal menstrual bleeding. These estimations were derived from mixed linear models based on diary data, hematological parameters and age. To validate the models, we applied our results to data from a third study with a similar patient population. RESULTS: The resulting best fitting model uses diary entries on bleeding intensity at a particular day, information on occurrence and frequency of single bleeding intensities in defined time windows, hemoglobin and ferritin values and age of the patient all as predictors of menstrual blood loss volume. Sensitivity and specificity for the diagnosis of excessive bleeding were 87% and 70%, respectively. Our model-based estimates reflect the subjective assessment by physicians and patients in the same way as the measured values do.When applying the model to an independent study, we found a correlation of 0.73 between estimated and measured values for the blood loss in a single day. Further models with reduced number of parameters (simplified for easier practical use) still showed correlation values between 0.69 and 0.73. CONCLUSIONS: We present a method for estimating menstrual blood loss volume in women suffering from prolonged or excessive menstrual bleeding. Our statistical model includes entries from bleeding diaries, laboratory parameters and age and produces results which correlate well with data derived by the alkaline-hematin-method. Therefore, this model may be used to estimate menstrual blood loss volume in both routine gynecological counseling and clinical studies.

Project description: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.

Project description:Menstruation is the expulsion of the endometrial lining of the uterus following a nearly month long preparation for embryo implantation and pregnancy. Increasingly, the health of the endometrium is being recognized as a critical factor in female fertility, and proteomes and transcriptomes from endometrial biopsies at different stages of the menstrual cycle have been studied for both diagnostic and therapeutic purposes (1 Kao, L. C., et al. 2003 Endocrinology 144, 2870-2881; Strowitzki, Tet al. 2006 Hum. Reprod. Update 12, 617-630; DeSouza, L., et al. 2005 Proteomics 5, 270-281). Disorders of the uterus ranging from benign to malignant tumors, as well as endometriosis, can cause abnormal menstrual bleeding and are frequently diagnosed through endometrial biopsy (Strowitzki, Tet al. 2006 Hum. Reprod. Update 12, 617-630; Ferenczy, A. 2003 Maturitas 45, 1-14). Yet the proteome of menstrual blood, an easily available noninvasive source of endometrial tissue, has yet to be examined for possible causes or diagnoses of infertility or endometrial pathology. This study employed five different methods to define the menstrual blood proteome. A total of 1061 proteins were identified, 361 were found by at least two methods and 678 were identified by at least two peptides. When the menstrual blood proteome was compared with those of circulating blood (1774 proteins) and vaginal fluid (823 proteins), 385 proteins were found unique to menstrual blood. Gene ontology analysis and evaluation of these specific menstrual blood proteins identified pathways consistent with the processes of the normal endometrial cycle. Several of the proteins unique to menstrual blood suggest that extramedullary uterine hematopoiesis or parenchymal hemoglobin synthesis may be occurring in late endometrial tissue. The establishment of a normal menstrual blood proteome is necessary for the evaluation of its usefulness as a diagnostic tool for infertility and uterine pathologies. Identification of unique menstrual blood proteins should aid the forensic community in distinguishing menstrual blood from circulating blood.

Project description:BackgroundGirls and women need effective, safe, and affordable menstrual products. Single-use menstrual pads and tampons are regularly provided by agencies among resource-poor populations. Reusable menstrual pads (RMPs: fabric layers sewn together by an enterprise for manufacture of menstrual products) may be an effective alternative.MethodsFor this review (PROSPERO CRD42020179545) we searched databases (inception to November 1, 2020) for quantitative and qualitative studies that reported on leakage, acceptability, or safety of RMPs. Findings were summarised or combined using forest plots (random-effects meta-analysis). Potential costs and environmental savings associated with RMPs were estimated.ResultsA total of 44 studies were eligible (~14,800 participants). Most were conducted in low- and middle-income countries (LMIC, 78%), and 20% in refugee settings. The overall quality of studies was low. RMP uptake in cohort studies ranged from 22-100% (12 studies). One Ugandan trial among schoolgirls found leakage with RMPs was lower (44.4%, n = 72) compared to cloths (78%, n = 111, p<0.001). Self-reported skin-irritation was 23.8% after 3 months among RMP-users in a Ugandan cohort in a refugee setting (n = 267), compared to 72.8% at baseline with disposable pad use. There were no objective reports on infection. Challenges with washing and changing RMP were reported in LMIC studies, due to lack of water, privacy, soap, buckets, and sanitation/drying facilities. Among 69 brands, the average price for an RMP was $8.95 (standard deviation [sd] $5.08; LMIC $2.06, n = 10, high-income countries [HIC] $10.11), with a mean estimated lifetime of 4.3 years (sd 2.3; LMIC 2.9, n = 11; HIC 4.9 years, n = 23). In 5-year cost-estimates, in LMICs, 4-25 RMPs per period would be cheaper (170-417 US$) than 9-25 single-use pads, with waste-savings of ~600-1600 single-use pads. In HICs, 4-25 RMPs would be cheaper (33-245 US$) compared to 20 single-use tampons per period, with waste-savings of ~1300 tampons.ConclusionRMPs are used internationally and are an effective, safe, cheaper, and environmentally friendly option for menstrual product provision by programmes. Good quality studies in this field are needed.

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A systematic review of methods to measure menstrual blood loss.

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A systematic review of methods to measure menstrual blood loss.

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