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Management of Adnexal Mass
Evidence Reports/Technology Assessments, No. 130
Investigators: Evan R Myers, MD, MPH, Lori A Bastian, MD, MPH, Laura J Havrilesky, MD, Shalini L Kulasingam, PhD, Mishka S Terplan, MD, Kathryn E Cline, MHS, Rebecca N Gray, DPhil, and Douglas C McCrory, MD, MHS.
Structured Abstract
Objectives:
To assess diagnostic strategies for distinguishing benign from malignant adnexal masses.
Data Sources:
MEDLINE® and reference lists of recent reviews; discharge data from the Nationwide Inpatient Sample.
Review Methods:
The major diagnostic methods evaluated were bimanual pelvic examination, ultrasound (morphology and Doppler velocimetry), MRI, CT, FDG-PET, CA-125, and scoring systems that incorporated multiple clinical, laboratory, and radiologic findings. Meta-analysis using a random-effects model was used to estimate pooled sensitivity and specificity for discriminating benign from malignant. We reviewed evidence for followup strategies for masses considered benign, and for adverse outcomes of diagnostic surgery. We also reviewed published models of the natural history of ovarian cancer and compared the impact of assumptions about natural history on outcomes.
Results:
The majority of studies did not describe whether patients presented with asymptomatic masses detected through screening or with symptoms. Prevalence of malignant masses in a U.S. postmenopausal screening population was approximately 0.1 percent, while benign masses were found in 0.8 to 1.8 percent of women. Pooled (a) sensitivity and (b) specificity were: bimanual exam (a) 0.45, (b) 0.90; ultrasound morphology scores (a) 0.86 to 0.91, (b) 0.68 to 0.83; Doppler resistive index (a) 0.72, (b) 0.90; pulsatility index (a) 0.80, (b) 0.73; maximum systolic velocity (a) 0.74, (b) 0.81; presence of vessels (a) 0.88, (b) 0.78; combined morphology and Doppler (a) 0.86, (b) 0.91; MRI (a) 0.91, (b) 0.88; CT (a) 0.90, (b) 0.75; FDG-PET (a) 0.67, (b) 0.79; and CA-125 (a) 0.78, (b) 0.78. Both sensitivity and specificity of CA-125 were better in postmenopausal than in premenopausal women. In modeled outcomes, combinations of imaging and CA-125 were both more sensitive and more specific than either alone. Performance of scoring systems in validation studies was consistently worse than in development studies; the highest demonstrated specificity observed was 0.91, with a concurrent sensitivity of 0.74. Evidence on followup strategies was sparse, although one large study provided good evidence for safely following unilocular cysts less than 10 cm in diameter. Overall complication rates in studies of surgically managed adnexal masses were low, but important clinical information was not reported.
Conclusions:
All diagnostic modalities showed trade-offs between sensitivity and specificity, but the available literature does not provide sufficient detail on relevant characteristics of study populations to allow confident estimation of the results of alternative diagnostic strategies. Although modeling studies may prove useful in evaluating diagnostic algorithms, further work is needed to explore the implications of uncertainty about the natural history of ovarian cancer.
Contents
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-02-0025. Prepared by: Duke Evidence-based Practice Center, Durham, North Carolina.
Suggested citation:
Myers ER, Bastian LA, Havrilesky LJ, Kulasingam SL, Terplan MS, Cline KE, Gray RN, McCrory DC. Management of Adnexal Mass. Evidence Report/Technology Assessment No. 130 (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-02-0025.) AHRQ Publication No. 06-E004. Rockville, MD: Agency for Healthcare Research and Quality. February 2006.
This report is based on research conducted by the Duke Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0025). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.
This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850. www
.ahrq.gov
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