Causes and consequences of oral contraceptive noncompliance.

Compliance difficulties are more common among oral contraceptive users than is generally appreciated. Inconsistent use and method discontinuation are estimated to account for approximately 20% of the annual 3.5 million annual unintended pregnancies in the United States. In the past research focused on adolescents, for whom predictors of poor oral contraceptive compliance include multiple sex partners, low evaluation of personal health, low degree of concern about pregnancy, and previous abortion. More recent research confirms that compliance problems are common among all age groups, with 47% of women missing >/=1 pill per cycle and almost a quarter (22%) missing >/=2 pills per cycle. Good compliance has been linked to patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take oral contraceptives, and reading information distributed with oral contraceptive packaging. Clinicians are the focal point for improving oral contraceptive compliance. They should focus counseling on the transience of most side effects, instructions on dealing with a missed pill, provision of a backup method, and establishment of a daily pill-taking routine. Easy-to-understand literature should be given to patients to take home.

Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons.

OBJECTIVES: Our purpose was to define the frequency and reasons for oral contraceptive discontinuation and subsequent contraceptive behavior. STUDY DESIGN: A nationwide prospective study of 1657 women initiating or switching to the use of a new contraceptive from private practices, clinics, and a health maintenance organization was performed. RESULTS: Six months after a new oral contraceptive prescription, 68% of new starts and 84% of switchers still used oral contraceptives. Of women who discontinued, 46% did so because of side effects, whereas 23% had no continuing need. More than four fifths of women who discontinued oral contraceptives but remained at risk of unintended pregnancy either failed to adopt another method or adopted a less effective method. Fifteen percent of women who discontinued oral contraceptives resumed their use within the 7-month follow-up period. CONCLUSIONS: Counseling should emphasize the possibility of side effects, stressing the fact that most will be transient, and the need to identify a backup method. Follow-up visits should be scheduled for 1 to 2 months after a prescription is written.

PIP: Oral contraception is the most commonly used contraceptive method in the US (approximately 30% of women in reproductive ages). This nationwide prospective cohort study was conducted to define the frequency and reasons for oral contraceptive discontinuation and subsequent contraceptive behavior. The study enrolled 1657 women who were starting or switching to new methods of contraceptives from private practices, clinics, and health maintenance organizations between March 1995 and May 1996. These women were given new contraceptive prescription during their visit to the physician. There were 3 questionnaires completed by the patients regarding their compliance to oral contraceptives and the use of the prescribed contraceptives. Results of the study show that 6 months after prescription was received, 68% of starters and 48% switchers continue the use of oral contraceptives, while 46% discontinued the method because of side effects and 23% felt there was no more need for continuation. Majority of the women who discontinued the use of oral contraceptives and were at risk of unintended pregnancy failed to use or adopt another method. This study concludes that counseling is vital particularly in presenting the possibility of side effects, stressing of the facts, and the need to identify a backup method, with follow-up visits after 1-2 months after receiving prescription.

Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation.

CONTEXT: Oral contraceptive users' risk of accidental pregnancy may be higher than it should be, because of inconsistent pill-taking. However, few reliable data are available on pill users' everyday experiences with their method, especially characteristics that may affect consistency of use. METHODS: Two months after initiating or resuming oral contraceptive use, a nationwide sample of 943 women completed questionnaires examining their compliance with instructions for proper use, the quality of their interactions with their provider, their satisfaction with the method, and the frequency and costs of visits or calls to their providers because of pill-related side effects. Regression analyses were used to determine the factors associated with compliance difficulties and method dissatisfaction. RESULTS: In all, 47% of users missed one or more pills per cycle, and 22% missed two or more. Women who lacked an established pill-taking routine, who did not read and understand all of the informational material accompanying the pill package, or who experienced spotting or heavy bleeding had increased odds of missing two or more pills per cycle. Method satisfaction was most likely among women who were aware of the pill's noncontraceptive benefits, were satisfied with their relationship with their provider, had used the pill in the past and experienced few side effects. Some 22% of users called their provider at least once about pill-related side effects, and 9% made at least one visit for this reason; these women spent $25 and $62, respectively, to treat side effects. CONCLUSIONS: Improving pill use is a shared responsibility of the provider, the patient and, to a lesser degree, pill manufacturers. Awareness of potential difficulties such as inadequate counseling is a key step in helping women use oral contraceptives effectively.

PIP: The Organon Contraceptive Use Study, a prospective cohort study (1994-96) of 943 US women (mean age, 25 years) recruited through private medical practices, Planned Parenthood clinics, and a health maintenance organization, examined oral contraceptive (OC) use patterns. 95% of study participants began or switched to a new OC brand at study enrollment. At follow up 2 months after enrollment, 47% of pill users reported missing 1 or more pill per cycle and 22% missed 2 or more pills in each cycle. Those who missed 1 or more pill were significantly more likely than those who did not to lack an established pill-taking routine, not to have read or understood the informational material accompanying the pill, and to have experienced spotting or heavy bleeding. 34% rated the OC as a very good method and another 30% considered it a good method. Method satisfaction was significantly higher among OC users who were aware of the pill's noncontraceptive health benefits, had a good relationship with their OC provider, had used the pill in the past, and experienced few side effects. 22% of OC recipients called their provider at least once about pill-related side effects and 9% visited at least once for this reason; these women spent US$25 and $62, respectively, to treat side effects. Recommended, to increase patient compliance and satisfaction with OCs, are measures such as counseling on potential side effects, evaluations of consistency of use at all follow-up contacts, and attention to the quality of the provider-client relationship.

Latex condom breakage and slippage in a controlled clinical trial.

Although millions of couples rely on male latex condoms to protect against unintended pregnancy and sexually transmitted infections, their use is limited in part by questions about their performance. Rates of condom breakage and slippage, two measures of performance, vary broadly across studies. This variation in part reflects study variability and limitations, including sample size, reliance on subjects' memory, user populations, and products evaluated. In an effort to define condom performance in a group of monogamous couples typical of those using condoms for contraception, we conducted a clinical trial of a single brand of lubricated condoms (Durex Ramses). A total of 4637 attempts to use the condom were evaluated. Six breaks occurred before intercourse (nonclinical breaks), and 10 condoms broke during intercourse or were only noted to have broken upon withdrawal (clinical breaks), resulting in a nonclinical breakage rate of 0.13% (95% confidence interval, 0.05-0.28%), clinical breakage rate of 0.28% (0.15-0.48%), and a total breakage rate of 0.41% (0.25-0.64%). The rate of complete slippage was 0.63% (0.42-0.90%), and total failure (clinical breaks plus complete slips) was 1.04% (0.76-1.37%). These rates are lower than those in other studies with the exception of one, a prospective investigation in a population of female prostitutes. Results indicate that condoms can, in experienced, motivated populations, provide excellent performance and suggest that their efficacy at preventing pregnancy may equal that of the most reliable forms of contraception. Because this study involved a single condom brand, these results may not be generalizable to other brands.

PIP: Rates of condom slippage and breakage were recorded for 4637 attempts to use the condom during sexual intercourse by 92 monogamous couples who had sex at least 8 times per month and had no history of fertility-impairing conditions, including sexually transmitted infections. The couples were comprised of men age 18-50 years and women age 18-40 years. They were at risk of pregnancy, and condoms were their sole method of birth control during the study. Lubricated Durex Ramses condoms were tested in this clinical trial. The men and women were of mean ages 28.8 and 26.8 years, respectively, 75.0% White, and either married or never married in approximately equal proportions. Nearly all participants completed high school and 75% lived with their current partner or spouse. 70-75% were experienced condom users, having used a condom more than 50 times with their current partner. 6 breaks occurred before intercourse and 10 condoms broke during intercourse or were noted to have broken upon withdrawal. These breakages amount to a nonclinical breakage rate of 0.13%, a clinical breakage rate of 0.28%, and a total breakage rate of 0.41%. No breakage or slippage occurred during the 4 reported acts of anal intercourse. The rate of complete slippage was 0.63% and total failure, clinical breaks plus complete slips, was 1.04%. These rates are lower than those in other studies except for 1 prospective study in a population of female prostitutes.

A comparison of "U" and standard techniques for Norplant removal.

OBJECTIVE: To evaluate the "U" technique versus the manufacturer-recommended technique for Norplant removal. METHODS: We conducted a randomized comparison of the manufacturer-recommended method of removal and the "U" technique. The latter involves an incision between and parallel to the third and fourth implants and uses a modified vasectomy clamp to remove the implants by pulling perpendicular to the implant's axis. RESULTS: Twenty-one physicians (three experienced, 18 inexperienced) performed 200 Norplant removals. Inexperienced physicians took significantly less time for removal using the "U" technique than the standard technique (7.9 versus 10.5 minutes), even after controlling for other factors. Experienced physicians also required less time for removal using the "U" technique (3.1 versus 3.7 minutes), but the difference was not statistically significant after controlling for other factors. Both experienced and inexperienced physicians broke implants more frequently using the standard technique, although the difference was significant only for experienced physicians (relative risk 3.6, 95% confidence interval 1.2, 10.8). No differences were noted between the techniques with respect to tissue damage or patient reports of pain during or after removal. CONCLUSIONS: These results suggest that the "U" technique is an improvement over the standard technique, particularly for personnel who are not highly experienced in Norplant removal.

Performance of the TCu380A and Cu-Fix IUDs in an international randomized trail.

To compare the clinical performance of the TCu380A, the most widely used copper IUD in the world today, and a new frameless device, the Cu-Fix, we report results from a randomized international two-year clinical trial involving 874 parous women followed for an average of fourteen months. Event rates at the end of two years (per 100 women) for pregnancy were 0.0 for the TCu380A and 1.5 for the Cu-Fix. Termination due to expulsion was significantly less for TCu380A as compared with Cu-Fix users (2.0 and 11.4 per hundred women, respectively); other medical reasons for termination (bleeding/pain, pelvic inflammatory disease (PID), and other) did not differ significantly. PID incidence rates at two years were 1.0 per hundred women for the TCu380A and 1.6 for the Cu-Fix (equivalent to 6.0 and 8.3 per 1,000 woman-years, respectively). The net cumulative continuation rates at two years per hundred women were 78.8 for TCu380A, and 71.9 for the Cu-Fix. Both IUDs provide highly effective protection against pregnancy, but the TCu380A has a lower expulsion rate. The low rate of PID indicates that it is an in-frequent occurrence in appropriately selected candidates.

The male polyurethane condom: a review of current knowledge.

Condoms are one of the oldest form of contraceptive and the best recognized form of protection against sexually transmitted diseases. Their use, however, is limited by both behavioral factors and device-related factors, including complaints about decreased sensitivity and sexual enjoyment. To address these limitations, a male condom made of polyurethane was developed. Polyurethane is a strong impermeable material with good heat transfer characteristics that is less susceptible to deterioration during storage than latex. Because little information is available comparing polyurethane and latex condoms in terms of consumer preferences as well as breakage and slippage, we reviewed four pre-marketing studies of polyurethane condoms, one of which included comparison to latex. No significant differences in slippage and breakage rates between latex and polyurethane condoms were reported in the study that included a latex comparator, and other studies of polyurethane condoms alone resulted in rates in the same range as published for latex condoms. Subjectively, consumers expressed significantly greater preference for the polyurethane condom over latex in regard to appearance, lack of smell, likelihood of slippage, comfort, sensitivity, natural look, natural feel, and overall. While additional testing is needed, these preliminary results suggest that the male polyurethane condom reviewed performed at least as well as latex condoms and is preferred by consumers. If preference translates to greater use, the male polyurethane condom may address important barriers that have been linked with inadequate condom use in the past. These results, however, may not be generalizable to other brands of polyurethane condom currently under development.

PIP: A literature review of four pre-marketing studies of the Avanti male polyurethane condom was conducted to compare consumer preferences, breakage, and slippage of polyurethane and latex condoms. The condom manufacturer, London International, recruited participants for these studies throughout the UK. In the only study that had two comparison groups, the polyurethane condom had the highest overall consumer reference rating (7.4 vs. 6.8; p = 0.002) and the lower breakage and slippage rates (0.9% vs. 2.1% and 0.4% vs. 1.1%, respectively). Slippage and breakage rates in the other three studies were similar to those in the literature for latex condoms. Consumers preferred the polyurethane condom to the latex condom because they perceived it as having a natural feel and look with no smell and enhanced sensitivity and comfort. The number of patients lost to follow-up was low for all four studies (no greater than 9%). The leading reason for not using any of the different condoms provided to study participants was lack of opportunity (56%). Additional research is needed, particularly studies with a comparison latex group. Clinical trials of the male polyurethane condom examining contraceptive efficacy, breakage, and slippage data are currently being conducted among 800 couples recruited in many centers. Nevertheless, the findings of the literature review suggest that the Avanti polyurethane condom perform at least as well as the latex condom and that consumers prefer the polyurethane condom. If preference increases use, the Avanti polyurethane condom may overcome barriers that have been associated with poor condom use in the past.

Smoking and cycle control among oral contraceptive users.

OBJECTIVE: Because cigarette smoking has a variety of antiestrogenic actions, we investigated the possibility that smoking may adversely affect spotting and bleeding among women using oral contraceptives. STUDY DESIGN: Three open-label, randomized clinical trials involving 16,506 cycles among 2956 oral contraceptive users were performed. RESULTS: Smokers reported a consistently higher frequency of spotting or bleeding than did nonsmokers. After recency and consistency of oral contraceptive use and progestin component were controlled for, smokers were, on average, 47% more likely to have spotting or bleeding than nonsmokers were over six cycles of oral contraceptive use, with higher levels of smoking associated with a greater frequency of spotting or bleeding. By the sixth cycle women who smoked > or = 16 cigarettes per day were almost three times more likely to have spotting or bleeding than were nonsmokers. CONCLUSION: Cigarette smoking adversely affects cycle control among oral contraceptive users, possibly by increasing estrogen catabolism. Although these findings also raise the possibility that oral contraceptive efficacy may also be impaired in smokers, an immediate concern is that oral contraceptive users who have spotting and bleeding are more likely to discontinue their use, placing them at risk of unintended pregnancy.

PIP: Three open-label, randomized clinical trials involving 16,506 cycles among 2956 oral contraceptive (OC) users were conducted in order to investigate whether smoking may adversely affect spotting and bleeding among women using OCs. Included were 1480 women and 8292 cycles of experience with gestodene preparations, 1384 women and 7691 cycles with OCs containing desogestrel, and 92 women and 523 cycles with the norgestimate preparation. Among smokers, the proportion who reported spotting or bleeding varied from 59% in the first cycle to 14% in the sixth cycle, averaging 23%. In contrast, the proportion of nonsmokers who reported bleeding ranged from 52% in the first cycle to 9% in the sixth cycle, averaging 19% for all six cycles. Although the proportion of smokers and nonsmokers with spotting or bleeding decreased significantly with time (p = .000), nonsmokers had a slight but consistent increase in spotting or bleeding for each cycle after the first, whereas spotting or bleeding in smokers decreased during the first two cycles and remained constant thereafter. After recency and consistency of OC use and progestin components were controlled for, smokers were 47% more likely to have spotting or bleeding than nonsmokers over six cycles of OC use with higher levels of smoking associated with a greater frequency of spotting or bleeding. By the sixth cycle women who smoked or= 16 cigarettes/day were almost three times more likely to have spotting or bleeding than nonsmokers. For women with any smoking, the relative risk (RR) was elevated for every cycle, with the difference being significant in five of six cycles. The RR for any smoking varied from 1.30 in the first cycle (an increase in risk of 30% compared with nonsmokers) to 1.86 (86% increase) by cycle six. Cigarette smoking adversely affects cycle control among OC users, possibly by increasing estrogen catabolism. Women who have spotting or bleeding are more likely to discontinue OC use, which places them at increased risk of unintended pregnancy.

The effect of desogestrel, gestodene, and other factors on spotting and bleeding.

Spotting and bleeding are among the most common side effects associated with oral contraceptive (OC) use and their occurrence is a prime determinant of whether a new user will continue to use OCs. Desogestrel and gestodene are two new progestins that were developed in part to minimize the occurrence of these side effects. Assessing the effect of these progestins is difficult, however, in part because their effects may be subtle, requiring a large sample size and possibly being overshadowed by other factors. To address these issues, we analyzed data from two comparative multicenter clinical trials that included 15,421 cycles among 2767 women. One study compared 75 micrograms gestodene + 30 micrograms ethinyl estradiol (EE) with 150 micrograms desogestrel + 30 micrograms EE, the other compared the same gestodene preparation with 150 micrograms desogestrel + 20 micrograms EE. Both studies found a higher risk of spotting or bleeding in all cycles among users of the desogestrel-containing preparation, with the differences ranging between 20% and 70% higher for the first study and 40% and 140% in the second. These differences were statistically significant in four of six cycles in each study and persisted after controlling for consistency and recency of OC use as well as smoking. After pooling the data and controlling for estrogen dose, the desogestrel-containing preparation was significantly associated with more frequent spotting or bleeding in five of six cycles. Smoking and consistency and recency of OC use were also independent predictors of spotting or bleeding.

Compliance and oral contraceptives: a review.

Compliance difficulties are more common among oral contraceptive (OC) users than generally appreciated by clinicians, in part because unintended pregnancy is a relatively infrequent consequence and in part because more common manifestations such as spotting and bleeding may not be recognized as resulting from poor compliance. While improving compliance is a shared responsibility of patients, clinicians, and manufacturers, the clinician is the focal point for these efforts. Counseling must be individualized, which requires knowledge of factors that predict compliance and an understanding of the patient's decision-making process as it relates to medications. Most OC compliance research has focused on adolescents, where predictors of poor compliance include multiple sex partners, low evaluation of personal health, degree of concern about pregnancy, and previous abortion. Good compliance has been linked with patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.

PIP: The findings of decades of research on user compliance of drug treatment regimens can be reduced to a simple statement that a third of users always comply, a third never complies, and a third sometimes complies. The efficacy of oral contraceptives (OC), however, relies on compliance even though poor compliance has no immediate or uniform consequences. Research on OC compliance has focused on adolescents because of their high pregnancy rates and their high reliance on OCs. Young women frequently use OCs in a sporadic fashion. While most adolescents are as compliant as older women, only 26% of those aged 14 and younger take their OC daily as compared to 40% of all other age groups. Attempts have been made to identify factors predicting noncompliance using 1) the individualistic model, which measures a number of factors using statistical techniques; 2) the health belief model which postulates that health-seeking behavior depends upon perception of health risk, and 3) the patient-provider model which highlights the importance of communication techniques. Factors which have been found to influence OC use are the occurrence of side effects, the routine followed, and failure to read and/or understand the packaging information. Little is known about the influence of patient-provider interactions, and only a few strategies to improve compliance have been studied. To improve compliance, health care providers should properly counsel women on their choice of method, side effects, OC misinformation and beneficial effects, correct use, missed pill instructions, and how to get additional information. Proper follow-up techniques should also be used. OC users can improve compliance by following a regular routine, carefully reading packaging information, knowing what to do if an OC is missed, and identifying a back-up method. Manufacturers should encourage research into compliance predictors and factors, incorporate findings into tools to help clinicians identify those at risk, use packaging that encourages compliance, and develop standardized and comprehensible written materials.

Unintended pregnancies and use, misuse and discontinuation of oral contraceptives.

Unintended pregnancies are a recognized occurrence among women using oral contraceptives (OCs) as a consequence of both user and method failure. However, OCs also influence the occurrence of unintended pregnancies through an additional, poorly recognized, route: cessation of OC use by women who do not wish to become pregnant but stop using OCs because of side effects or other reasons. Many such women fail to immediately substitute a new contraceptive and/or adopt a less reliable contraceptive. This is a particularly important consideration for the approximately 3.7 million women who begin taking OCs in the United States each year since this group commonly experiences side effects and has a high discontinuation rate. Using a decision tree to follow a cohort of OC users over one year, we estimate that over 1 million unintended pregnancies are related to OC use, misuse or discontinuation. The greatest proportion of these, 61%, occur in women who discontinue OCs; of these, 66.6% occur in women who fail to immediately substitute other contraceptives and 33.3% because of the adoption of less reliable contraceptive methods. Of continuing OC users, the majority, exhibiting good compliance, contribute 24% of pregnancies because of their large numbers. Continuing OC users who are poor compliers, though many fewer, are responsible for 15% due to their high pregnancy rate. Unintended pregnancies in women who discontinue OCs account for approximately 20% of the 3.5 million annual unintended pregnancies in the United States, incurring costs of nearly +2.6 billion.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: Findings from clinical trials and a survey of 10,000 users of oral contraceptives (OCs) formed the basis for developing a decision tree or chart that reproductive medicine specialists used to follow a cohort of OC users annually. They used a sensitivity analysis to estimate that OC use, misuse, or discontinuation are associated with 1,045,000 unintended pregnancies in the US each year. 61% of these unintended pregnancies occur to women who discontinue OCs. About 20% of women who discontinue OCs do not immediately adopt another contraceptive method. 33.3% occur because the women substituted OCs with less reliable contraceptive methods. Continuing OC users with good compliance account for 24% of the unintended pregnancies. Continuing OC users with poor compliance make up 15% of unintended pregnancies. Their number was much lower than that of good compliers (2.05 vs. 11.6 million). If all women used OCs correctly, about 687,000 unintended pregnancies would not occur. Physicians need to stress the need for immediate adoption of another reliable contraceptive if OC use is discontinued and the patient does not wish to conceive. They should counsel new OC adopters to expect side effects (e.g., bleeding) and that these side effects are temporary. This should reduce OC discontinuation.

Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation.

The contraceptive efficacy of oral contraceptives (OCs) depends on their proper and continued use, particularly with lower estrogen preparations. However, few studies have examined why women miss pills or discontinue OCs, and those that do tend to be small and to focus on adolescents. To address the issues of poor OC compliance and early OC discontinuation, we analyzed OC use in a convenience sample of 6,676 women between the ages of 16 and 30 from Denmark, France, Italy, Portugal, and the United Kingdom. Logistic regression was used to examine the independent effect of each factor. Poor compliance was associated with a lack of established routine for pill-taking (relative risk [RR] = 3.3), failure to read and understand written materials that came with the OC package (RR = 2.2), not receiving adequate information or help about OCs from their health care provider (RR = 1.5), and occurrence of certain side effects, including hirsutism (RR = 2.1), nausea (RR = 1.4), bleeding irregularities (RR = 1.3), and breast tenderness (RR = 1.2). Women who were inconsistent OC users, missing one or more pills per cycle, were almost three times as likely to experience an unintended pregnancy while using OCs than were women who took their OCs consistently. Factors that predicted early discontinuation (women who wished to continue contraceptive protection but discontinued OC use) were primarily side effects, including nausea (RR = 2.1), bleeding (RR = 1.9), breast tenderness (RR = 1.8), mood changes (RR = 1.8), and weight gain (RR = 1.4).(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: To address the issues of poor oral contraceptive (OC) compliance and early OC discontinuation, OC use was analyzed in a convenience sample of 6676 women between the ages of 16 and 30 from Denmark, France, Italy, Portugal, and the United Kingdom, obtained from the Wyeth-Ayerst Contraceptive survey conducted in 1993. Logistic regression was used to examine the independent effect of each factor. 81% of the women used their OCs consistently. User characteristics accounted for inconsistent use. Poor compliance was associated with a lack of established routine for pill-taking and failure to read and understand written materials that came with the OC package. Those who understood little or none of the instructions were 2.4 times more likely to be among women who missed 2 or more pills per cycle. Other factors for inconsistent use included not receiving adequate information or help about OCs from their health care provider (RR = 1.5), and occurrence of certain side effects, including hirsutism (RR = 2.1), nausea (RR = 1.4), bleeding irregularities such as breakthrough bleeding and amenorrhea (RR = 1.3), and breast tenderness (RR = 1.2). Women who were inconsistent OC users, missing 1 or more pills per cycle, were 2.6 times as likely to experience an unintended pregnancy while using OCs than were women who took their OCs consistently. Factors that predicted early discontinuation (women who wished to continue contraceptive protection but discontinued OC use) were primarily side effects, including nausea (RR = 2.1), bleeding in the first 3 months (RR = 1.9), breast tenderness (RR = 1.8), mood changes (RR = 1.8), hair growth (RR = 1.7), and weight gain (RR = 1.4). Multiple side effects substantially increased the likelihood of discontinuation, with a single side effect increasing the risk by 50%, 2 by 220%, and 3 by 320%. Improved compliance can be facilitated if providers emphasize the need to continue to take OCs reliably even if side effects do occur.

Doxycycline or ofloxacin for outpatient chlamydial pelvic inflammatory disease? A cost-benefit and cost-effectiveness analysis.

OBJECTIVE: The current Centers for Disease Control and Prevention (CDC) guidelines include 2 drugs, doxycycline and ofloxacin, for treatment of the chlamydial component of outpatient pelvic inflammatory disease (PID). Although ofloxacin costs about $90 more than doxycycline, doxycycline is frequently associated with side effects and patient compliance with this drug is probably poor. Because clinicians have little information by which to judge the tradeoffs between price and compliance for these 2 antibiotics, we examined the impact of patient compliance in the evaluation of the costs and benefits of using each drug. METHODS: The incidence and direct costs of PID sequelae (infertility, ectopic pregnancy, and chronic pelvic pain) resulting after partially treated chlamydial PID were taken from previous estimates. For differing levels of antibiotic compliance, the probability of cure, probability of the occurrence of sequelae, and the associated cost of each were calculated. Because the relationship between partial antibiotic compliance and PID cure is unknown, we included 3 plausible relationships in our analyses. The sensitivity analysis was performed by varying key assumptions and examining the effect of each on future costs. RESULTS: The average probability of future PID sequelae attributable to chlamydia is slightly less than 2%, with an associated cost of $1,272. With an average compliance for doxycycline of 50%, an improvement in compliance of as little as 1.8-3.5 percentage points (51.8-53.5%), depending on the assumption used regarding partial compliance and cure, would make the use of ofloxacin less costly than doxycycline in the long run. Even with a cost difference of $90 between the 2 drugs, a 10-percentage-point increase in compliance (to 60% compliance) with the more expensive drug would save $2.63 for each $1.00 spent. CONCLUSIONS: Since the long-term costs of PID are likely to overshadow the immediate cost of providing treatment, physicians should carefully consider the likelihood of patient compliance in selecting an antibiotic.