Female Pelvic Medicine & Reconstructive Surgery:
1University of Texas Southwestern Medical Center, Dallas, TX; 2Henry Ford Health System, Detroit, MI; 3Women and Infants Hospital of Rhode Island / Brown Medical School, Providence, RI; 4Women and Infants Hospital of Rhode Island / Brown Medical School, Providence, RI; 5University of New Mexico Health Sciences Center, Albuquerque, NM; 6Kaiser Permanente, San Francisco, CA; 7Cleveland Clinic, Cleveland, OH; 8University of Texas Southwestern Medical Center, Dallas, TX; 9University of South Carolina, Greenville, SC; 10Tufts Medical Center, Boston, MA; 11Tufts Medical Center, Boston, MA
DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS: None.
Abnormal uterine bleeding (AUB) adversely affects many women's health. The large societal and personal burden of AUB lies in its major impact on quality of life, productivity, healthcare utilization, and costs. While hysterectomy cures AUB, several less invasive surgical and medical options are increasingly being used. We aimed to (1) systematically collect and organize into categories all outcomes reported in trials for AUB; (2) rank the importance of outcomes for patient decision-making; and, thus, (3) facilitate comparisons of effectiveness of treatments in trials of AUB interventions.
MATERIALS AND METHODS:
A systematic review undertaken by the Society of Gynecologic Surgeons Systematic Review Group (SRG) identified English-language randomized controlled trials (RCTs) of AUB treatments in MEDLINE from 1950 to June 2008. Trials included pre- or perimenopausal women with idiopathic AUB (dysfunctional uterine bleeding) and/or fibroids. Interventions included hysterectomy, myomectomy, endometrial ablation, uterine artery embolization, and medical therapies. All outcomes and definitions were extracted and organized into major overarching outcome categories. After conducting a narrative review of available literature on patient experience with AUB and patient-based outcomes measures for AUB, the SRG voted on each outcome and ranked them ‘critically important’, ‘important’ or ‘not important’ for informing patients' choices following Grading of Recommendations Assessment, Development and Evaluation (GRADE) terminology. This review process considered the clinical relevance of the outcome to the patient as well as the quality of the measuring instrument.
113 articles from 79 trials met inclusion criteria. 114 different outcomes were identified, 15 (13%) of which were ranked critically important and 29 (25%) important. Outcomes were grouped into 8 overarching categories: 1) bleeding; 2) quality of life; 3) pain; 4) sexual health; 5) patient satisfaction; 6) bulk-related complaints; 7) need for subsequent surgical treatment; and 8) adverse events. Just 3 trials (4%) used condition-specific quality of life tools while there were no validated instruments to assess disease-specific impact on pain, sexual health, bulk-related symptoms, or patient satisfaction.
Our review underscores a dearth of high-quality, standardized instruments for measuring patient-based outcomes in AUB or consistent use of the measures that do exist. To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health and bulk-related symptoms both before and after treatment and reporting satisfaction with treatment and adverse events. Further development of validated patient-based outcomes measures and the standardization of outcome reporting are needed.