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J Clin Epidemiol. 2011 Mar;64(3):293-300. doi: 10.1016/j.jclinepi.2010.03.017. Epub 2010 Aug 12.

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

Author information

  • 1University of Texas Southwestern Medical Center, Dallas, TX, USA. David.Rahn@utsouthwestern.edu

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.

Copyright © 2011 Elsevier Inc. All rights reserved.

PMID:
20705427
[PubMed - indexed for MEDLINE]
PMCID:
PMC3057176
Free PMC Article

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