Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB.
Highlights
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Impact on quality of life is an important aspect of heavy menstrual bleeding.
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Quality of life assessment is essential for women with heavy menstrual bleeding.
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Patient-reported outcome measures facilitate quality of life assessment.
Introduction
The symptom of abnormal uterine bleeding (AUB) is defined as any abnormality in the frequency, duration, regularity, or volume of menstrual bleeding and affects up to 30% of women at some point in their reproductive years . Heavy menstrual bleeding (HMB), a subset of AUB, has been defined in a variety of objective and more patient-oriented ways. Objectively, HMB has been defined as >80 ml mean menstrual blood loss in a menstrual period . However, the comprehensiveness and clinical utility of this definition have been questioned, as more than two-thirds of women seeking medical care for the problem of HMB would not meet this objective criterion. This suggests that something other than the quantity of blood lost per cycle is more important to women suffering from HMB and leading them to seek care . The National Institute for Health and Clinical Excellence (NICE) proposed a more comprehensive patient-centered definition in their 2007 Clinical Guidelines on HMB: “ heavy menstrual bleeding is excessive menstrual blood loss that interferes with a woman’s physical, social, emotional, and/or material quality of life.”
This definition reflects an evolution in the assessment and management of patients with HMB with a focus on how the symptom is experienced by the woman and how it affects her day-to-day life. Many women with HMB experience embarrassing episodes of bleeding through their clothes and passage of blood clots that cannot be contained with standard menstrual products. Several studies in the United Kingdom have shown that women report HMB on the basis of changes in their bleeding pattern, passing blood clots, frequency of changing menstrual products, and inability to contain menstrual flow . As a result, women engage in avoidance behavior, changing work schedules, changing plans with their family, and avoiding social activities . Other studies have suggested that pain, mood changes, and tiredness, symptoms separate from the “heaviness” of the bleeding were most problematic for women with HMB . Together, these constellations of symptoms directly or indirectly associated with HMB adversely affect quality of life. Compared to women without HMB, women with HMB are less likely to rate their health as excellent or good and have reported lost work wages as a result of missed time from work . In the United States, treating HMB costs over $1 billion annually, which balloons to $12–36 billion if indirect costs (such as lost work wages and productivity) are included.
HMB is not a straightforward symptom to assess and treat. First, there are multiple treatment options for HMB, and treatment options vary in appropriateness and effectiveness based on the etiology of the symptom. HMB can be caused by nine different etiologies (polyps, adenomyosis, leiomyoma, malignancy/hyperplasia, coagulopathy, ovulatory dysfunction, endometrial dysfunction, iatrogenic, not otherwise classified) . Additionally, women may have more than one etiology contributing to their symptom complex. Treatment options vary in terms of effectiveness, indications, contraindications, and side effects and are dependent on the etiology of the bleeding. The complexity of HMB, which affects different women differently and can impact multiple aspects of a woman’s life, has to be considered when evaluating women with this symptom in the clinical setting and research.
Evaluating women with HMB in clinical research
Misalignment of patient expectations and symptom assessment has been a limitation of research comparing treatments for HMB. Traditionally, research on HMB has used objectively measured mean menstrual blood loss (using the alkaline hematin method) extracted from sanitary products as an eligibility criteria (women needing at least 80 ml mean menstrual blood loss per cycle for participation) and reduction in mean menstrual blood loss as a main outcome measure . This measurement evaluates only the blood component of menstrual discharge and requires availability of specialized laboratory equipment for assessment. Although this type of menstrual blood loss quantification could be useful for some studies, relying upon cut-offs of mean menstrual blood loss for study eligibility has likely led to the inclusion of study populations that may not be reflective of the clinical population of women seeking treatment for HMB; nearly half of all women reporting HMB lose less than 40 ml of menstrual blood loss per cycle . Moreover, although reduction in bleeding is usually desirable for patients, using this objective measurement alone fails to capture the patient experience and bleeding-related quality of life.
Studies on HMB have increasingly incorporated patient-reported outcome measures (PROMS) to evaluate the impact of bleeding on quality of life. PROMs include standardized interviews, questionnaires, charts, and surveys that assess the patient’s own evaluation of her health and symptoms. PROMs can be administered one time (for diagnosis and symptom assessment) or multiple times (for following symptom and progress over time) and can be generic or disease/symptom-specific.
A systematic review of 80 studies on HMB used PROMs, of which 70 used PROMs specifically designed to evaluate bleeding symptoms or bleeding-related quality of life . Fifty different PROMs were used across these studies: 7 quantified the amount of bleeding using charts or diaries, 23 evaluated menstrual or gynecologic symptoms, and 20 assessed both bleeding-related symptoms and quality of life. Examples of PROMs used in HMB research are summarized in Table 1 .
| Name of the Instrument | Brief Description |
|---|---|
| Instruments that quantify bleeding | |
| Pictorial Bleeding Assessment Chart (PBAC) | Pictorial bleeding assessment charts (PBAC). Women provided with standard sanitary pads and tampons use a chart to record number of pads used each day and amount of staining (represented by diagrams on the chart) of the pad and episodes of blood clots and flooding. The chart is used to generate a score that represents (but does not exactly approximate) menstrual blood loss (MBL) per cycle. |
| Menstrual pictogram | Menstrual pictogram similar to the Higham PBAC – the difference is that it provides an estimate of MBL rather than an empirical score. |
| Superabsorbent polymer-c pictogram | Menstrual pictogram (building of previous charts and pictograms described above) designed to be used for contemporary menstrual products (super-absorbency). Provides an estimate of MBL. |
| Instruments that assess bleeding symptoms | |
| The Menstrual Evaluation Questionnaire (MEQ) | Multi-item questionnaire developed as a tool for clinical assessment of symptoms associated with heavy menstrual bleeding (HMB). The MEQ includes statements about bleeding symptoms and asks women to report the presence/absence of the symptoms and rate them in terms of severity and their contribution to her healthcare seeking. |
| Multidimensional questionnaires (both menstrual symptoms and quality of life) | |
| Aberdeen Menorrhagia Severity Scale (AMSS) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with 13 items on characteristics of the symptom, pain, problems with bleeding through clothes, work life, leisure activities, and sex life. Scores to items are summed and weighted where 0 is the best possible score and 100 the worst. |
| Menorrhagia Multiattribute Scale (MMAS) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with six items on practical difficulties, social life, mental health, physical health, work life, and family life. Responses are scored and weighted. Generates a score of 0 (most severe impact) to 100 (no impact). |
| Menstrual Impact Questionnaire (MIQ) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with six items total on perceived amount of blood lost, impact on work, impact on physical activities, social activities, number of activities limited, and perceived impact of treatment on symptoms. |
| Menstrual Bleeding Questionnaire (MBQ) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with 20 items and includes perception of heaviness of bleeding, bleeding pattern, pain, and impact of symptoms including social embarrassment, fear of social embarrassment, and behavioral changes to avoid social embarrassment. Sum responses to obtain a total score and multiply score by 1.32 to scale. Zero, least impact possible; 100, worst impact possible. |
Charts and pictograms for bleeding quantification
Semiquantitative methods of assessing the amount of menstrual blood lost per cycle have been commonly used in clinical research. The most commonly used semiquantitative assessment, the Pictorial Bleeding Assessment Chart (PBAC), requires women to chart the number and amount of saturation of menstrual products (pads and tampons) and generates a summative score reflecting menstrual blood loss . Charts and pictograms have been developed since the PBAC and involved a broader range of options for product saturation and more contemporary high-absorbency menstrual products . A recent study by Magnay et al developed and validated a pictogram that generates an estimate of menstrual blood loss and can be used with modern high-absorbency sanitary products . Menstrual bleeding charts and pictograms may be good tools for practical assessment of menstrual blood loss and change over time in response to treatment.
Questionnaires to assess bleeding symptoms and related quality of life
Studies have suggested that disease/symptom-specific PROMs should be used to evaluate women with HMB . However, no single instrument has been considered “standard” for use across all studies on treatment of HMB.
There are several examples of good quality validated menstrual bleeding specific symptom and symptom impact questionnaires. The Menorrhagia Evaluation Questionnaire (MEQ) was developed as a tool for clinical assessment of symptoms associated with HMB . The MEQ includes statements about bleeding symptoms and asks women to report the presence/absence of the symptoms and rate them in terms of severity and their contribution to her healthcare seeking. The Aberdeen Menorrhagia Severity Scale (AMSS), developed in 1995 by Ruta et al, has been widely used for assessing bleeding-specific quality of life . An internally consistent and reliable health status questionnaire specific to HMB, the AMSS includes questions about the heaviness of the menstrual bleeding, the duration of menstrual bleeding, and the effect of the bleeding on day-to-day life (work, leisure activities, and sex life). The score of the AMSS is generated using a re-coded value summation and adjustment to produce a transformed score of zero (best possible score) to 100 (worst possible score). The menorrhagia multiattribute scale (MMAS), developed in 1995 by Shaw et al, was extensively assessed for validity and used as an outcome measure for the ECLIPSE trial in the United Kingdom that compared the levonorgestrel intrauterine system to usual care for women with HMB . The MMAS measures impact of HMB with six items on practical difficulties, social life, mental health, physical health, work life, and family life. Responses are scored and weighted, and the MMAS generates a score of 0 (most severe impact) to 100 (no impact).
More recently, the Menorrhagia Impact Questionnaire (MIQ) and the Menstrual Bleeding Questionnaires (MBQ) have been developed and validated for use in studies for HMB . The MIQ, developed in the context of studies to evaluate effectiveness of tranexamic acid for the treatment of HMB, is a six-item questionnaire that measures limitations on activities and patient perception of changes in menstrual blood loss . The MBQ, developed independently of any treatment trials, included the concepts measured in the AMSS and MIQ but, based on in-depth input from women suffering from HMB, additionally incorporated social embarrassment, fear of social embarrassment, and behavior changes to avoid episodes of social embarrassment, which as mentioned previously in this chapter are significant drivers of reduced quality of life in this population of women . Although the advantage of using the MIQ is that it is brief, the advantage of using the MBQ is its measurement of social embarrassment and the fact that it is shown to be unaffected by recall bias (by comparing data captured retrospectively at one month to data collected daily using handheld devices), which can be a concern when collecting patient-reported outcomes for chronic and intermittent symptoms.
Health-related quality of life (HRQOL) questionnaires
General health (as opposed to symptom or disease focused) quality of life questionnaires have been used commonly across studies evaluating women with HMB. The Short Form-36 (SF-36) is a 36-item HRQOL instrument that generates an overall “score” based on scores across eight domains of health and functioning . The EQ5D and the Short-Form-12 (SF-12) have also been used in HMB research . Although HRQOL instruments such as SF-36 have been validated for use in studies on HMB, women have reported that some of the questions are difficult to answer because HMB is an intermittent symptom and it is typically not life-threatening . Studies have shown suboptimal correlation between disease-specific instruments such as the MBQ or the Uterine Fibroids Symptoms Quality of Life (UFS-QOL) questionnaire and the SF-36 . However, these generic instruments can be helpful when used in combination with condition or disease-specific questionnaires because they facilitate comparison of symptom impact/disease impact across a variety of medical problems.
Other questionnaires (anxiety, depression, sexual health)
Surveys of women with HMB have suggested that stress surrounding bleeding concealment, mood changes, and tiredness related to HMB are major drivers of the adverse impact bleeding has on the quality of life . Several questionnaires have been used in studies on HMB to evaluate these impacts including The Hospital Anxiety and Depression Scale (HADS) , State-Trait Anxiety Inventory (STAI) , Beck’s Depression Inventory , and Mental Health Index . Although some studies have shown that issues surrounding sexual function are important to women suffering from HMB, others have suggested that women with HMB think that sexual function questions are more relevant to their partners than they are for themselves . The McCoy Sex Scale is the most commonly used sexual functioning questionnaire used across studies on HMB .
Issues with clinical questionnaires in HMB research
Recent systematic reviews on HMB have highlighted the lack of consistency of outcome measurement across studies as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options . Because the method of assessing outcomes differs from study to study, data cannot be combined or summarized for these outcomes (such as quality of life and bleeding-related quality of life). Recently, national organizations and consortia of journal editors have focused on the impact of inconsistent measurement of outcomes in clinical trials and research and collaborated to develop initiatives such as the Patient Reported Outcomes Measurement Information System (PROMIS) and the Core Outcomes in Women’s Health (CROWN) to generate standardized outcome measures and advocate for their use in future studies. These initiatives are discussed in more detail later in the chapter.
Evaluating women with HMB in clinical research
Misalignment of patient expectations and symptom assessment has been a limitation of research comparing treatments for HMB. Traditionally, research on HMB has used objectively measured mean menstrual blood loss (using the alkaline hematin method) extracted from sanitary products as an eligibility criteria (women needing at least 80 ml mean menstrual blood loss per cycle for participation) and reduction in mean menstrual blood loss as a main outcome measure . This measurement evaluates only the blood component of menstrual discharge and requires availability of specialized laboratory equipment for assessment. Although this type of menstrual blood loss quantification could be useful for some studies, relying upon cut-offs of mean menstrual blood loss for study eligibility has likely led to the inclusion of study populations that may not be reflective of the clinical population of women seeking treatment for HMB; nearly half of all women reporting HMB lose less than 40 ml of menstrual blood loss per cycle . Moreover, although reduction in bleeding is usually desirable for patients, using this objective measurement alone fails to capture the patient experience and bleeding-related quality of life.
Studies on HMB have increasingly incorporated patient-reported outcome measures (PROMS) to evaluate the impact of bleeding on quality of life. PROMs include standardized interviews, questionnaires, charts, and surveys that assess the patient’s own evaluation of her health and symptoms. PROMs can be administered one time (for diagnosis and symptom assessment) or multiple times (for following symptom and progress over time) and can be generic or disease/symptom-specific.
A systematic review of 80 studies on HMB used PROMs, of which 70 used PROMs specifically designed to evaluate bleeding symptoms or bleeding-related quality of life . Fifty different PROMs were used across these studies: 7 quantified the amount of bleeding using charts or diaries, 23 evaluated menstrual or gynecologic symptoms, and 20 assessed both bleeding-related symptoms and quality of life. Examples of PROMs used in HMB research are summarized in Table 1 .
| Name of the Instrument | Brief Description |
|---|---|
| Instruments that quantify bleeding | |
| Pictorial Bleeding Assessment Chart (PBAC) | Pictorial bleeding assessment charts (PBAC). Women provided with standard sanitary pads and tampons use a chart to record number of pads used each day and amount of staining (represented by diagrams on the chart) of the pad and episodes of blood clots and flooding. The chart is used to generate a score that represents (but does not exactly approximate) menstrual blood loss (MBL) per cycle. |
| Menstrual pictogram | Menstrual pictogram similar to the Higham PBAC – the difference is that it provides an estimate of MBL rather than an empirical score. |
| Superabsorbent polymer-c pictogram | Menstrual pictogram (building of previous charts and pictograms described above) designed to be used for contemporary menstrual products (super-absorbency). Provides an estimate of MBL. |
| Instruments that assess bleeding symptoms | |
| The Menstrual Evaluation Questionnaire (MEQ) | Multi-item questionnaire developed as a tool for clinical assessment of symptoms associated with heavy menstrual bleeding (HMB). The MEQ includes statements about bleeding symptoms and asks women to report the presence/absence of the symptoms and rate them in terms of severity and their contribution to her healthcare seeking. |
| Multidimensional questionnaires (both menstrual symptoms and quality of life) | |
| Aberdeen Menorrhagia Severity Scale (AMSS) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with 13 items on characteristics of the symptom, pain, problems with bleeding through clothes, work life, leisure activities, and sex life. Scores to items are summed and weighted where 0 is the best possible score and 100 the worst. |
| Menorrhagia Multiattribute Scale (MMAS) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with six items on practical difficulties, social life, mental health, physical health, work life, and family life. Responses are scored and weighted. Generates a score of 0 (most severe impact) to 100 (no impact). |
| Menstrual Impact Questionnaire (MIQ) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with six items total on perceived amount of blood lost, impact on work, impact on physical activities, social activities, number of activities limited, and perceived impact of treatment on symptoms. |
| Menstrual Bleeding Questionnaire (MBQ) | Bleeding-specific symptom and quality of life instrument that measures impact of HMB with 20 items and includes perception of heaviness of bleeding, bleeding pattern, pain, and impact of symptoms including social embarrassment, fear of social embarrassment, and behavioral changes to avoid social embarrassment. Sum responses to obtain a total score and multiply score by 1.32 to scale. Zero, least impact possible; 100, worst impact possible. |
Charts and pictograms for bleeding quantification
Semiquantitative methods of assessing the amount of menstrual blood lost per cycle have been commonly used in clinical research. The most commonly used semiquantitative assessment, the Pictorial Bleeding Assessment Chart (PBAC), requires women to chart the number and amount of saturation of menstrual products (pads and tampons) and generates a summative score reflecting menstrual blood loss . Charts and pictograms have been developed since the PBAC and involved a broader range of options for product saturation and more contemporary high-absorbency menstrual products . A recent study by Magnay et al developed and validated a pictogram that generates an estimate of menstrual blood loss and can be used with modern high-absorbency sanitary products . Menstrual bleeding charts and pictograms may be good tools for practical assessment of menstrual blood loss and change over time in response to treatment.
Questionnaires to assess bleeding symptoms and related quality of life
Studies have suggested that disease/symptom-specific PROMs should be used to evaluate women with HMB . However, no single instrument has been considered “standard” for use across all studies on treatment of HMB.
There are several examples of good quality validated menstrual bleeding specific symptom and symptom impact questionnaires. The Menorrhagia Evaluation Questionnaire (MEQ) was developed as a tool for clinical assessment of symptoms associated with HMB . The MEQ includes statements about bleeding symptoms and asks women to report the presence/absence of the symptoms and rate them in terms of severity and their contribution to her healthcare seeking. The Aberdeen Menorrhagia Severity Scale (AMSS), developed in 1995 by Ruta et al, has been widely used for assessing bleeding-specific quality of life . An internally consistent and reliable health status questionnaire specific to HMB, the AMSS includes questions about the heaviness of the menstrual bleeding, the duration of menstrual bleeding, and the effect of the bleeding on day-to-day life (work, leisure activities, and sex life). The score of the AMSS is generated using a re-coded value summation and adjustment to produce a transformed score of zero (best possible score) to 100 (worst possible score). The menorrhagia multiattribute scale (MMAS), developed in 1995 by Shaw et al, was extensively assessed for validity and used as an outcome measure for the ECLIPSE trial in the United Kingdom that compared the levonorgestrel intrauterine system to usual care for women with HMB . The MMAS measures impact of HMB with six items on practical difficulties, social life, mental health, physical health, work life, and family life. Responses are scored and weighted, and the MMAS generates a score of 0 (most severe impact) to 100 (no impact).
More recently, the Menorrhagia Impact Questionnaire (MIQ) and the Menstrual Bleeding Questionnaires (MBQ) have been developed and validated for use in studies for HMB . The MIQ, developed in the context of studies to evaluate effectiveness of tranexamic acid for the treatment of HMB, is a six-item questionnaire that measures limitations on activities and patient perception of changes in menstrual blood loss . The MBQ, developed independently of any treatment trials, included the concepts measured in the AMSS and MIQ but, based on in-depth input from women suffering from HMB, additionally incorporated social embarrassment, fear of social embarrassment, and behavior changes to avoid episodes of social embarrassment, which as mentioned previously in this chapter are significant drivers of reduced quality of life in this population of women . Although the advantage of using the MIQ is that it is brief, the advantage of using the MBQ is its measurement of social embarrassment and the fact that it is shown to be unaffected by recall bias (by comparing data captured retrospectively at one month to data collected daily using handheld devices), which can be a concern when collecting patient-reported outcomes for chronic and intermittent symptoms.
Health-related quality of life (HRQOL) questionnaires
General health (as opposed to symptom or disease focused) quality of life questionnaires have been used commonly across studies evaluating women with HMB. The Short Form-36 (SF-36) is a 36-item HRQOL instrument that generates an overall “score” based on scores across eight domains of health and functioning . The EQ5D and the Short-Form-12 (SF-12) have also been used in HMB research . Although HRQOL instruments such as SF-36 have been validated for use in studies on HMB, women have reported that some of the questions are difficult to answer because HMB is an intermittent symptom and it is typically not life-threatening . Studies have shown suboptimal correlation between disease-specific instruments such as the MBQ or the Uterine Fibroids Symptoms Quality of Life (UFS-QOL) questionnaire and the SF-36 . However, these generic instruments can be helpful when used in combination with condition or disease-specific questionnaires because they facilitate comparison of symptom impact/disease impact across a variety of medical problems.
Other questionnaires (anxiety, depression, sexual health)
Surveys of women with HMB have suggested that stress surrounding bleeding concealment, mood changes, and tiredness related to HMB are major drivers of the adverse impact bleeding has on the quality of life . Several questionnaires have been used in studies on HMB to evaluate these impacts including The Hospital Anxiety and Depression Scale (HADS) , State-Trait Anxiety Inventory (STAI) , Beck’s Depression Inventory , and Mental Health Index . Although some studies have shown that issues surrounding sexual function are important to women suffering from HMB, others have suggested that women with HMB think that sexual function questions are more relevant to their partners than they are for themselves . The McCoy Sex Scale is the most commonly used sexual functioning questionnaire used across studies on HMB .
Issues with clinical questionnaires in HMB research
Recent systematic reviews on HMB have highlighted the lack of consistency of outcome measurement across studies as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options . Because the method of assessing outcomes differs from study to study, data cannot be combined or summarized for these outcomes (such as quality of life and bleeding-related quality of life). Recently, national organizations and consortia of journal editors have focused on the impact of inconsistent measurement of outcomes in clinical trials and research and collaborated to develop initiatives such as the Patient Reported Outcomes Measurement Information System (PROMIS) and the Core Outcomes in Women’s Health (CROWN) to generate standardized outcome measures and advocate for their use in future studies. These initiatives are discussed in more detail later in the chapter.
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