Noncompliance among a group of women using a novel method of contraception.

OBJECTIVE

To compare the incidence of noncompliance measured objectively by a home use fertility monitor with the traditional self-reported incidence of compliance in a study of a new method of contraception.

DESIGN

Prospective cohort study.

SETTING

A large family planning clinic in Edinburgh.

PATIENT(S): Thirty-two healthy women who took part in a trial assessing the efficacy of a novel method of contraception involving accurately timed administration of a single dose of mifepristone.

INTERVENTION(S): Mifepristone was administered orally and a blood sample was collected on the same day.

MAIN OUTCOME MEASURE(S): Percentage of missed tests detected by the monitor against the self-reported percentage during the critical period.

RESULT(S): Women failed to perform 24.2% (95% confidence interval, 16.5-31.5) of the tests in the 162 cycles analyzed. They missed tests at an absolutely vital time for contraceptive efficacy in 42% of cycles according to the monitor while admitting to missing tests in 14.8%. Poor compliance was associated with younger women, those who discontinued the study before completion, and cycles in which women were not relying on the contraceptive method.

CONCLUSION(S): The use of microelectronic monitoring systems may improve our understanding of the extent of patient noncompliance, providing objective information that no other monitoring technique can produce. This understanding provides the opportunity to make the optimum use of potentially effective treatments while validating research evidence.