Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials

Abstract

Objectives (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions. Study Design and Setting Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked “critically important,” “important,” or “not important” for informing patients’ choices. Results One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight 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. Conclusion 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 and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed.

Abnormal Uterine Bleeding, Health Status, and Usual Source of Medical Care: Analyses Using the Medical Expenditures Panel Survey

“…6,7 Quality of life is not measured in a standardized fashion across studies on AUB and little information is available on the impact of AUB on quality of life measures from a national population-level perspective. 6,7,8 The available population-level studies have shown that women with AUB have increased utilization of health resources compared to women without AUB.…”

Comparison of Therapeutic Efficacies of Norethisterone, Tranexamic Acid and Levonorgestrel-Releasing Intrauterine System for the Treatment of Heavy Menstrual Bleeding: A Randomized Controlled Study

“…The task of comparing the different types of therapies is difficult because of the subjective and variable nature of the presenting symptoms in dysfunctional uterine bleeding [33]. The importance of each outcome measure was graded on a scale designed by the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) working group [34].…”

Clinical Practice Guideline for Abnormal Uterine Bleeding: Hysterectomy versus Alternative Therapy

“…The importance of each outcome for clinical decision making was determined by consensus in the SGS-SRG [8]. The systematic review for this guideline included only outcomes of critical or high importance.…”

“…In developing this guideline, we were faced with inconsistent measurement and reporting of a great number of outcomes [8]. We addressed this by categorizing outcomes and ranking their relative importance to weigh results when determining the net balance of benefits and harms.…”