A randomized trial among women with heavy menstruation -- impact of a decision aid on treatment outcomes and costs.

OBJECTIVE

To evaluate the effects of a decision aid for menorrhagia on treatment outcomes and costs over a 12-month follow-up.

DESIGN

Randomized trial and pre-trial prospective cohort study.

SETTING AND PARTICIPANTS

Gynaecology outpatient clinics in 14 Finnish hospitals, 363 (randomized trial) plus 206 (cohort study) patients with menorrhagia.

INTERVENTION

A decision aid booklet explaining menorrhagia and treatment options, mailed to patients before their first clinic appointment.

MAIN OUTCOME MEASURES

Health related quality of life, psychological well-being, menstrual symptoms, satisfaction with treatment outcome, use and cost of health care services.

RESULTS

All study groups experienced overall improvement in health-related quality of life, anxiety, and psychosomatic and menstrual symptoms, but not in sexual life. Treatment in the intervention group was more active than in the control group, with more frequent course of medication and less undecided treatments. However, there were no marked disparities in health outcomes, satisfaction with treatment outcome and costs. Total costs (including productivity loss) per woman because of menorrhagia over the 12-month follow-up were 2760 and 3094 in the intervention and control group, respectively (P = 0.1). The pre-trial group also had a significantly lower rate of uterus saving surgery compared with the control group, but no difference in costs because of menorrhagia treatment.

CONCLUSION

Despite some differences in treatment courses, a decision aid for menorrhagia in booklet form did not increase the use of health services or treatment costs, nor had it impact on health outcomes or satisfaction with outcome of treatment.