MEASURING CONTRACEPTIVE

FAILURE
James Trussell
Office of Population Research
Princeton University

Issues

Efficacy versus effectiveness

Typical versus perfect use
Pearl index versus life table
Non-completion of trial
Common errors in literature
Results from literature
Communicating the risk of failure

Efficacy versus Effectiveness

Efficacy: how well a method works under
ideal circumstances
Effectiveness: how well a method works in
the real world
Efficacy would be measured in a clinical trial
whereas effectiveness would be measured in
a survey or a chart review

Sources of Data
Surveys: NSFG 1973, 1976, 1982, 1988, 1995, 2002
Nationally representative
Retrospective
Underreporting of abortion
Overreporting of contraceptive failure leading to birth?

Clinical trials
Hawthorne effect and inference beyond trial setting
Cycles of perfect use can be identified and pregnancy
rates during perfect use can be estimated but adherence is
self-reported

Results from the 1995 NSFG:

% becoming pregnant in the first year of
use uncorrected and corrected for
underreporting of abortion
Method

Uncorrected

Corrected

Pill

7.3

8.5

Condom

9.7

14.9

Spermicides

16.6

28.2

Fu. Fam Plan Perspect 1999;31:56-

Self-Reporting of Adherence
Self reports on missed OCs compared with
electronic recording on punched pills among
103 women for 3 cycles
Agreement on only 45% of days
Overreporting of no missed pills (53-59%
versus 19-33%)
Underreporting of missing 3+ pills (10-14%
versus 30-51%)

Potter. Fam Plan Perspect 1996;28:154

Typical Use versus Perfect Use

Contraceptive failure during typical use can
be measured in a clinical trial or in a survey
Contraceptive failure during perfect use has
been measured only in clinical trials, since
retrospective reporting of adherence in
surveys is likely to be terrible

What Is Typical Use?

By definition, a woman is a user whenever
she considers herself to be using a method
Hence, typical use of a barrier method does
not imply that it is actually used at every act
of intercourse
Typical use includes both inconsistent use
and incorrect use

What Is Perfect Use?

By definition, perfect use of a method
requires actual use according to the
directions for that method
Perfect use of a barrier method requires that
it be used correctly at every act of
intercourse
Perfect use does not imply no pregnancies

Logical Error Ingrained in Literature

Suppose in a contraceptive trial there are
100 years of exposure to risk of pregnancy
15 pregnancies occur during a cycle of
imperfect use
5 pregnancies occur during a cycle of perfect
use
What is the method-related pregnancy rate
(pregnancy rate during perfect use)?

Method-Related Pregnancy Rate

Traditional answer
5/100 = 5 per 100 woman-years of exposure

Logical error
Denominator cannot be all exposure since by
definition a method-related pregnancy can occur
only during perfect use
If there are only 50 woman-years of perfect use,
correct answer is 5/50 = 10 per 100 womanyears of exposure

Flaw in Design of Clinical Trials

Information on perfect (correct and consistent)
use is usually obtained only for cycles when
pregnancy occurred
Hence, pregnancy rates during perfect use
cannot be estimated in most trials

Correct Analysis by Cycle

P
Woman 1:
P
Woman 2:
Woman 3:
Woman 4:
P = pregnancy

Cycles: imperfect use

perfect use
Rates: 1/3
1/15 2/18

all

Pearl Index versus Life Table

Pearl index is a pregnancy rate: pregnancies
per 100 woman-years of exposure
Ranges from 0 to 1300, not 0 to 100
Rubber yardstick: women most likely to become
pregnant do so early, leaving behind a pool
increasing consisting of the more compliant and
less fecund

Life table methods produce estimates of the

percent of women becoming pregnant within
specific durations (e.g. 6 or 12 or 24 months)
since initiating use

Pearl Index Is a Rubber Yardstick

Two investigators using the same data
obtained pregnancy rates of 7.5 and 4.4
during 100 woman-years of condom use
One (who got 4.4) allowed each women to
contribute up to 5 years of exposure whereas
the other (who got 7.5) allowed each women
to contribute only up to 1 year of exposure
Which is correct?

Non-Completion of Trial
In the ideal trial, all women would either
become pregnant or complete the trial
without becoming pregnant
But in fact a high fraction stop for other
reasons (LFU, medical reasons, personal
reasons)
What is the consequence?

Consequence of Non-Completion of Trial

In life-table analysis, those who are censored
are assumed to have the same failure rate as
those who are observed, probably resulting in
a downward bias
In a Pearl index, more complex to assess: if
those who are censored would have had a
higher risk of pregnancy, observed Pearl
index could be biased upward or downward

Example: Effect of Non-Completion

100 women start trial, 10 become pregnant at 6
months
50 women followed after 6 months, 1 of whom
becomes pregnant at 12 months
40 women LFU at 6 months, 2 of whom would have
become pregnant at 12 months
Observed Pearl index = (10+1)/(50+25)=14.7
True Pearl index = (10+1+2)/(50+25+20)=13.7
Observed life-table probability=11.8%
True life-table probability=13%

Factors That Influence Failure

Inherent efficacy of the method
Imperfect use, the extent of which will
depend on motivation to avoid pregnancy
Frequency of intercourse, which declines
with both age and marital duration
Individual level of fecundity, which also
declines with age
Competence (honesty?) of the investigator

Common Errors
Incorrect calculation of method failure
Multiplying cycles by 1200 instead of 1300 to
get pregnancies per 100 woman years of
exposure
Not including learning phase
Discontinuing non-adherent women

Common Problems
High percent not completing trial
Underreporting of abortion
Use of Pearl index when comparing risk of
failure among methods

Problems in Comparing Methods

Results come from different sources; results
where available for typical use come from the
NSFG, adjusted for underreporting of abortion
Women choose which method to use and are
not randomly assigned to methods. Women
who choose to use spermicides are very
different from those who choose to use IUDs

Results from Literature

Table 27-1 from the 2007 edition of
Contraceptive Technology
Estimates of the annual risk of contraceptive
failure during perfect and typical use of no
method, spermicides, withdrawal, fertility
awareness based methods, sponge,
diaphragm, male and female condom, pill,
patch, ring, injectable, IUD, implant, tubal
ligation, and vasectomy

What Table 27-1 Shows

Methods requiring adherence generally show
a big difference between perfect-use and
typical-use failure rates
The most effective methods during typical
use are those not requiring adherence
The most effective methods are not those
that protect against STIs

Communicating Risk of Failure

Two studies have examined
How well do women understand contraceptive failure
rates?
How to communicate contraceptive effectiveness?

Result is a chart that appears in the new

WHO Global Handbook for Family Planning
Providers and the new edition of
Contraceptive Technology
Steiner. Obstet Gynecol 1996;88:24S-30S
Steiner. Obstet Gynecol 2003;102:709-17

Comparing typical effectiveness of contraceptive methods

More effective

How to make your method

most effective

Less than 1 pregnancy per

100 women in one year

After procedure, little or nothing to

do or remember
Female
Sterilization

Vasectomy

Implant

Vasectomy: Use another method for

first 3 months

IUD

Injections: Get repeat injections on

time
LAM (for 6 months): Breastfeed often,
day and night
Injectables

Pills

LAM

Patch

Ring

Pills: Take a pill each day

Patch, ring: Keep in place, change on
time
Condoms, diaphragm, sponge: Use
correctly every time you have sex
Fertility-awareness based methods:
Abstain or use condoms on fertile days.

Male
Condoms

Female
Condoms

Diaphragm

Sponge

Fertility-Awareness
Based Methods

Newest methods (Standard Days Method and

TwoDay Method) may be the easiest to use.

Withdrawal, spermicide: Use

correctly every time you have sex
Withdrawal

Spermicides

Less effective
About 30 pregnancies per
100 women in one year

Source WHO 2006, adapted with permission