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


METHODS
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.


CONCLUSIONS
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.
Rahn
David D
DD
University of Texas Southwestern Medical Center, Dallas, TX, USA. David.Rahn@utsouthwestern.edu
Abed
Husam
H
Sung
Vivian W
VW
Matteson
Kristen A
KA
Rogers
Rebecca G
RG
Morrill
Michelle Y
MY
Barber
Matthew D
MD
Schaffer
Joseph I
JI
Wheeler
Thomas L
TL
Balk
Ethan M
EM
Uhlig
Katrin
K
D004717:Endometrium / Q000601:surgery; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000601:surgery; D017063:Outcome Assessment, Health Care / Q000145:classification / Q000706:statistics & numerical data*; D017060:Patient Satisfaction; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D016879:Salvage Therapy; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055357:Uterine Artery Embolization; D014592:Uterine Hemorrhage / Q000453:epidemiology / Q000628:therapy*; D014594:Uterine Neoplasms / Q000601:surgery