Table 2.

Recommended outcome categories in trials for abnormal uterine bleeding

Outcome category	Key symptoms or outcomes
Bleeding	Amount Frequency Duration Irregularity and pattern Symptom bother Primary problem and if resolved after treatment
Quality of life	Disease-specific measures preferable Generic measures can augment bleeding-specific measures to make comparison with other disease processes
Pain	Bleeding-related pain
Sexual health	Disease-specific measures preferable Generic sexual health measures can augment bleeding-specific measures to make comparisons with other disease processes
Bulk-related symptoms	For studies in women with uterine leiomyomas
Patient satisfaction	Self-explanatory
Additional treatments	Additional conservative or surgical treatments required during minimum 1-yr recommended follow-up period
Adverse events	Clearly define adverse events Seriousness and severity of event Expected or unexpected event Specify number and type of each type of adverse event in each study arm Describe the number and type of any procedures or hospitalizations related to the first intervention within 30 d of intervention or initiating therapy per arm