• Fleischer AC, Andreotti RF, Bohm-Velez M, Horrow MM, Hricak H, Javitt MC, Thurmond A, Zelop C, Expert Panel on Women's Imaging. Abnormal vaginal bleeding. [online publication]. Reston (VA): American College of Radiology (ACR); 2006. 5 p. [23 references]

This is the current release of the guideline.

The appropriateness criteria are reviewed annually and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

Abnormal vaginal bleeding

Diagnosis

Family Practice
Internal Medicine
Obstetrics and Gynecology
Radiology

Health Plans
Hospitals
Managed Care Organizations
Physicians
Utilization Management

To evaluate the appropriateness of initial radiologic examinations for patients with abnormal vaginal bleeding

Women with abnormal vaginal bleeding

1. Ultrasound (US)
   • Uterus, transvaginal (TV)
   • Pelvis, transabdominal (TA)
   • Uterus, hysterosonogram
   • Doppler
2. Magnetic resonance imaging (MRI), pelvis
3. Computed tomography (CT), pelvis

Utility of radiologic examinations in differential diagnosis

Searches of Electronic Databases

The guideline developer performed literature searches of peer-reviewed medical journals and the major applicable articles were identified and collected.

The total number of source documents identified as the result of the literature search is not known.

Weighting According to a Rating Scheme (Scheme Not Given)

Not stated

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

One or two topic leaders within a panel assume the responsibility of developing an evidence table for each clinical condition, based on analysis of the current literature. These tables serve as a basis for developing a narrative specific to each clinical condition.

Expert Consensus (Delphi)

Since data available from existing scientific studies are usually insufficient for meta-analysis, broad-based consensus techniques are needed for reaching agreement in the formulation of the appropriateness criteria. The American College of Radiology (ACR) Appropriateness Criteria panels use a modified Delphi technique to arrive at consensus. Serial surveys are conducted by distributing questionnaires to consolidate expert opinions within each panel. These questionnaires are distributed to the participants along with the evidence table and narrative as developed by the topic leader(s). Questionnaires are completed by participants in their own professional setting without influence of the other members. Voting is conducted using a scoring system from 1-9, indicating the least to the most appropriate imaging examination or therapeutic procedure. The survey results are collected, tabulated in anonymous fashion, and redistributed after each round. A maximum of three rounds is conducted and opinions are unified to the highest degree possible. Eighty percent agreement is considered a consensus. This modified Delphi technique enables individual, unbiased expression, is economical, easy to understand, and relatively simple to conduct.

If consensus cannot be reached by the Delphi technique, the panel is convened and group consensus techniques are utilized. The strengths and weaknesses of each test or procedure are discussed and consensus reached whenever possible. If "No consensus" appears in the rating column, reasons for this decision are added to the comment sections.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

Criteria developed by the Expert Panels are reviewed by the American College of Radiology (ACR) Committee on Appropriateness Criteria.

ACR Appropriateness Criteria®

Clinical Condition: Abnormal Vaginal Bleeding

Variant 1: Postmenopausal vaginal bleeding.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 2: Postmenopausal vaginal bleeding, endometrium <5 mm by transvaginal ultrasound.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 3: Postmenopausal vaginal bleeding, endometrium > 5 mm by transvaginal ultrasound.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field

Variant 4: Premenopausal vaginal bleeding.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field

Variant 5: Premenopausal vaginal bleeding, endometrium <16 mm by transvaginal ultrasound.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 6: Premenopausal vaginal bleeding, endometrium >16 mm by transvaginal ultrasound.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Virtually every woman will at some point in her lifetime experience episodes of vaginal bleeding that will be perceived as abnormal. Menses begin at puberty and extend to menopause. The average menstrual cycle is 29 days long with a range of 23-39 days. Overall, the length of the menstrual cycle remains relatively constant throughout the reproductive years, but as a woman approaches menopause, the cycle gradually shortens. Although blood loss is difficult to quantify, most blood loss occurs in the first few days of menses, and bleeding generally lasts from 2 to 7 days. The cycle length and the volume and duration of bleeding remain fairly constant for a woman throughout her reproductive years. After menopause, bleeding ceases completely. Any variation from this pattern is potentially abnormal.

Abnormal vaginal bleeding is most often caused by hormone imbalance. Vaginal bleeding is also caused by pregnancy, polyps, myomas, endometrial hyperplasia, adenomyosis and cancers of the cervix or endometrium. In a premenopausal or perimenopausal woman, who is not pregnant, the most likely cause of abnormal bleeding is anovulatory cycles. It may also be associated with adenomyosis in parous women. In a postmenopausal woman, the most likely cause of abnormal bleeding is atrophic endometrium. In either case, a trial of medical hormonal therapy can be instituted. If bleeding persists despite medical management, imaging studies are warranted. In younger women, the goal is to diagnose polyps, myomas, or other focal structural causes for bleeding. In older women the goal is the same and includes diagnosis of endometrial cancer, which is the underlying cause in 10% of postmenopausal women with abnormal bleeding. Meta-analysis has shown that an endometria >5 mm is associated with less than 1% probability of endometrial cancer.

Transvaginal Ultrasound

Transvaginal ultrasound (TVUS) depicts endometrial pathology. The upper limit of normal for endometrial thickness has been debated. For premenopausal women with bleeding, a thickness of >16 mm has a sensitivity of 67%, specificity of 75%, and positive predictive value of 14% for demonstrating relevant pathology. For postmenopausal women with bleeding, a thickness of >5 mm has a sensitivity of at least 82% for detecting relevant pathology, and for detecting endometrial cancer has a sensitivity of 80%-100% and a specificity of about 60%. Few clinicians advocate mandatory uterine sampling for abnormal postmenopausal bleeding regardless of the ultrasound findings. Most, however, suggest that endometrial sampling is not necessary if thickness is <5 mm. When the endometrium is thickened, the vaginal sonogram helps localize focal lesions, thereby reducing the risk of missing lesions at sampling.

Myometrial pathology causing menorrhagia can be diagnosed by both TVUS and MRI. Although both modalities can be used effectively to diagnose adenomyosis and differentiate it from leiomyomas, TVUS is usually the first imaging study obtained in patients with abnormal bleeding. Using specific criteria, sonography demonstrates a sensitivity of 80%-86% and specificity of 50%-96%.

Hysterosonography

Hysterosonography consists of introduction of saline into the uterine cavity via a small catheter using TVUS guidance. In 48 postmenopausal women with bleeding and endometrial thickness between 5-10 mm, the distension of the cavity with saline revealed focal cavitary masses in 19 (40%). Seven of the patients with endometrial masses had biopsy prior to hysterosonography, and the biopsy was false negative in four (57%). In both premenopausal and postmenopausal women with abnormal bleeding and endometrial thickening, the exclusion of a focal mass may help direct management to hormone treatment or blind biopsy, whereas the identification of a focal mass may direct management to hysteroscopically-guided biopsy.

Transabdominal Ultrasound

Although transabdominal ultrasound gives an overall view of the pelvis, the depiction of the endometrium is better with TVUS. 3D sonography, either transabdominal or transvaginal, can detect endometrial lesions better than 2D due to depiction of the endometrium in the coronal plane.

Doppler Ultrasound

In postmenopausal women with vaginal bleeding, there is evidence to suggest that the uterine artery resistive index and the pulsatility index are lower for endometrial cancer than for benign lesions. There is, however, variability from institution to institution and overlap between benign and malignant findings. In general, duplex Doppler ultrasound does not add significant additional information to gray-scale imaging of the endometrium. However, color Doppler sonography can identify the feeding vessel of a polyp, significantly aiding their detection.

Magnetic Resonance Imaging

MRI of the pelvis is not warranted unless bleeding is attributed to leiomyomas and myomectomy is contemplated, or sonography is indeterminate in differentiating adenomyosis from leiomyomas. MRI accurately depicts the size, number, and location of leiomyomas. Using specific criteria, MRI differentiates adenomyosis from leiomyomas with a high degree of accuracy.

Computed Tomography

CT scan of the pelvis is not warranted for diagnosis of abnormal vaginal bleeding.

Abbreviations

• CT, computed tomography
• MRI, magnetic resonance imaging
• US, ultrasound

Algorithms were not developed from criteria guidelines.

The recommendations are based on analysis of the current literature and expert panel consensus.

Selection of appropriate radiologic imaging procedures for patients with abnormal vaginal bleeding

Not stated

An American College of Radiology (ACR) Committee on Appropriateness Criteria and its expert panels have developed criteria for determining appropriate imaging examinations for diagnosis and treatment of specified medical condition(s). These criteria are intended to guide radiologists, radiation oncologists, and referring physicians in making decisions regarding radiologic imaging and treatment. Generally, the complexity and severity of a patient's clinical condition should dictate the selection of appropriate imaging procedures or treatments. Only those exams generally used for evaluation of the patient's condition are ranked. Other imaging studies necessary to evaluate other co-existent diseases or other medical consequences of this condition are not considered in this document. The availability of equipment or personnel may influence the selection of appropriate imaging procedures or treatments. Imaging techniques classified as investigational by the U.S. Food and Drug Administration (FDA) have not been considered in developing these criteria; however, study of new equipment and applications should be encouraged. The ultimate decision regarding the appropriateness of any specific radiologic examination or treatment must be made by the referring physician and radiologist in light of all the circumstances presented in an individual examination.

An implementation strategy was not provided.

Getting Better

Effectiveness

• Fleischer AC, Andreotti RF, Bohm-Velez M, Horrow MM, Hricak H, Javitt MC, Thurmond A, Zelop C, Expert Panel on Women's Imaging. Abnormal vaginal bleeding. [online publication]. Reston (VA): American College of Radiology (ACR); 2006. 5 p. [23 references]

Not applicable: The guideline was not adapted from another source.

2006

American College of Radiology - Medical Specialty Society

The American College of Radiology (ACR) provided the funding and the resources for these ACR Appropriateness Criteria®.

Committee on Appropriateness Criteria, Expert Panel on Women's Imaging

Panel Members: Arthur C. Fleischer, MD; Rochelle F. Andreotti, MD; Marcela Böhm-Vélez, MD; Mindy M. Horrow, MD; Hedvig Hricak, MD, PhD; Marcia C. Javitt, MD; Amy Thurmond, MD; Carolyn Zelop, MD

Not stated

This is the current release of the guideline.

The appropriateness criteria are reviewed annually and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

None available

This NGC summary was completed by ECRI on August 25, 2006.