FACTORS ASSOCIATED WITH DISCONTINUATION OF HORMONAL CONTRACEPTIVES by Kathleen J. Ly B.A., University of Pittsburgh, 2012 Submitted to the Graduate Faculty of Graduate School of Public Health in partial fulfillment of the requirements for the degree of Master of Public Health University of Pittsburgh 2014 UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH This essay is submitted by Kathleen J. Ly on August 8, 2014 and approved by Essay Advisor: Martha Ann Terry, PhD ___________________________________ Assistant Professor Department of Behavioral and Community Health Sciences Graduate School of Public Health University of Pittsburgh Essay Reader: Elizabeth M. Felter, DrPH ___________________________________ Visiting Assistant Professor Department of Behavioral and Community Health Sciences Graduate School of Public Health University of Pittsburgh Essay Reader: Tammy M. Haley, PhD Associate Professor Department of Nursing University of Pittsburgh, Bradford ___________________________________ ii Copyright © by Kathleen J. Ly 2014 iii Martha Ann Terry, PhD FACTORS ASSOCIATED WITH DISCONTINUATION OF HORMONAL CONTRACEPTIVES Kathleen Ly, MPH University of Pittsburgh, 2014 ABSTRACT Family planning is considered one of the top 10 public health achievements of the 20th century by the Centers for Disease Control and Prevention (CDC), and use of hormonal contraceptives has only increased since its invention in the 1960s. Yet there is a noticeable lack of research and discussion on how to encourage patients to continue their use of contraception. Discontinuation of contraception is an issue of public health significance, since it often leads to unintended pregnancies that are costly to the individual and public as a whole. This literature review examines the extant literature on rates of discontinuation of the following hormonal methods of contraception: oral contraceptives, intrauterine devices, injectable contraceptives, vaginal rings, patches, and implant contraceptives. In addition, the review also examines demographic factors that have been associated with discontinuation, such as age, intimate partner violence, reproductive coercion, ethnicity, and socioeconomic status. Based on the literature reviewed, it appears that the most common reason for discontinuation is side effects. While providers usually cannot mitigate side effects of hormonal contraceptives, as they are often unpredictable, other studies have shown that discussing these side effects and other concerns that patients may have about the contraceptive that they are beginning or are currently taking can increase continuation as well as compliance with their regimen. iv TABLE OF CONTENTS 1.0 INTRODUCTION .............................................................................................. 1 2.0 BACKGROUND ............................................................................................... 4 2.1 3.0 UNINTENDED PREGNANCY – TRENDS, COSTS, AND OUTCOMES .. 8 METHODS ..................................................................................................... 12 3.1 4.0 DESCRIPTION OF STUDIES ................................................................. 12 RESULTS ...................................................................................................... 16 4.1 REASONS GIVEN FOR DISCONTINUATION OF HORMONAL CONTRACEPTIVES .............................................................................................. 16 4.2 DISCONTINUATION OF HORMONAL METHODS ............................... 18 4.2.1 ORAL CONTRACEPTION (COMBINED AND PROGESTIN-ONLY) . 19 4.2.2 INTRAUTERINE DEVICES (HORMONAL AND COPPER) ............... 24 4.2.3 INJECTABLE CONTRACEPTION (DEPOT MEDROXYPROGESTERONE [DMPA] AND COMBINED) ........................... 28 4.2.4 VAGINAL RING .................................................................................. 32 4.2.5 PATCH ................................................................................................ 35 4.2.6 IMPLANT ............................................................................................ 37 4.3 OTHER FACTORS ASSOCIATED WITH CONTRACEPTIVE DISCONTINUATION ............................................................................................. 40 v 4.3.1 AGE .................................................................................................... 40 4.3.2 INTIMATE PARTNER VIOLENCE AND REPRODUCTIVE COERCION ............................................................................................................ 41 4.3.3 SOCIOECONOMIC STATUS AND ETHNICITY ................................. 41 5.0 DISCUSSION ................................................................................................. 43 5.1 DISCONTINUATION OF CONTRACEPTION ........................................ 43 5.2 IMPLICATIONS FOR PRACTICE: CLIENT-PROVIDER INTERACTIONS AND COUNSELING .............................................................................................. 45 6.0 CONCLUSION ............................................................................................... 51 6.1 LIMITATIONS AND DIRECTIONS FOR FUTURE RESEARCH ............ 53 6.2 PUBLIC HEALTH SIGNIFICANCE ........................................................ 54 BIBLIOGRAPHY ........................................................................................................... 55 vi LIST OF TABLES Table 1. Choice of contraceptive methods among US women in 2010, listed by popularity......................................................................................................................... 6 Table 2. Failure rates of various types of contraception over one year, by method, listed by effectiveness of perfect use ........................................................................................ 7 Table 3. Summary of oral contraceptive studies reviewed, with most common reason given for discontinuation................................................................................................ 19 Table 4. Other reasons for discontinuation of oral contraceptive .................................. 21 Table 5. Summary of oral contraception articles reviewed, with no reason for discontinuation given in study ....................................................................................... 22 Table 6. Summary of copper intrauterine device articles reviewed ............................... 24 Table 7. Summary of hormonal intrauterine device articles reviewed ........................... 26 Table 8. Summary of articles reviewed, intrauterine device (type not stated) ............... 27 Table 9. Summary of injectable contraceptive (DMPA) articles reviewed, with most common reason for discontinuation............................................................................... 29 Table 10. Summary of injectable contraceptive (DMPA) articles reviewed, with no reason for discontinuation given in study ...................................................................... 30 Table 11. Summary of injectable contraceptive (combined or type not stated) articles reviewed ........................................................................................................................ 32 vii Table 12. Summary of vaginal ring articles reviewed, with most common reason reason for discontinuation ......................................................................................................... 33 Table 13. Summary of vaginal ring articles reviewed, with no reason for discontinuation given in study ................................................................................................................ 34 Table 14. Summary of patch contraceptive articles reviewed ....................................... 36 Table 15. Summary of implant contraceptive articles reviewed, with most common reason for discontinuation ............................................................................................. 37 viii LIST OF FIGURES Figure 1. Results of literature search............................................................................. 13 Figure 2. Reasons given for discontinuation of contraceptives given in studies reviewed ...................................................................................................................................... 18 Figure 3. Discontinuation rates of oral contraception, by time (months) and percentage ...................................................................................................................................... 23 Figure 4. Discontinuation rates of copper intrauterine device, by time (months) and percentage .................................................................................................................... 25 Figure 5. Discontinuation rates of hormonal intrauterine device, by time (months) and percentage .................................................................................................................... 26 Figure 6. Discontinuation rates of intrauterine device, type not stated, by time (months) and percentage ............................................................................................................. 28 Figure 7. Discontinuation rates of injectable DMPA, by time (months) and percentage 31 Figure 8. Discontinuation rates of vaginal ring contraceptive, by time (months) and percentage .................................................................................................................... 35 Figure 9. Discontinuation rates of implant contraceptives, by time (months) and percentage .................................................................................................................... 39 Figure 10. 24 Indicators of Care Assessed by RamaRao et al., 2003 ........................... 47 ix 1.0 INTRODUCTION The Centers for Disease Control and Prevention (CDC) consider family planning to be one of the greatest public health achievements of the 20 th century (CDC, 1999). The ability for families to decide when to have children and to determine family size without sexual abstinence has been key to improving the health of children and women. The birth control movement in America began in the 20 th century, and the science behind contraception has only improved since. In the 1960s, the first major hormonal contraceptive became available: the birth control pill. Since then, many other hormonal methods have been invented and used to great success. The advantage of hormonal contraception over barrier methods of birth control is that use does do not disrupt foreplay, and it is considerably more effective and reliable in preventing pregnancy when properly used. The fact that use does not necessarily coincide with sexual intercourse also makes hormonal methods useful in the case of unexpected sexual intercourse or sexual assault. The advantages of barrier methods are that they do not require a doctor’s visit and prescription, are readily available and affordable to most, and they do not produce the physiological side effects of hormonal methods, which are often off-putting to users. Additionally, besides abstinence, barrier methods are the only reliable way to prevent transmission of sexually transmitted diseases. Natural methods, such as the rhythm or withdrawal method, breastfeeding, 1 and the basal temperature method, are less reliable at preventing pregnancy and may require more user action than either barrier methods or hormonal methods. Lastly, male and female sterilization are extremely effective at preventing pregnancy, but are not considered reversible, and are not preferred by many couples for this reason. This paper explores the reasons that women discontinue use of hormonal methods. Often, healthcare practitioners and educators discuss how to encourage women to begin using contraception, to promote women’s health and socioeconomic future. However, the CDC has estimated (Daniels, Mosher, & Jones. 2013) that 30% of American women have tried five or more contraceptive methods, indicating that discontinuation is common. Public health practitioners and healthcare providers rarely, if ever, discuss how to encourage women to stay on their contraception once they begin using it; this is an equally important issue since consistency is the key to contraceptive success. Because the mechanisms, behavioral components, and costs of contraceptive methods vary so greatly, this paper examines only hormonal contraceptive use: oral contraceptives, intrauterine devices, injectable contraceptives, vaginal rings, dermal adhesive patch contraceptives, and implantable contraceptives. Though it is a form of hormonal contraception, emergency contraception such as the morning-after pill is not included in this review, since it is not a form of birth control that requires continuation. For the purposes of this paper, discontinuation is defined as stopping usage of that method of birth control, with or without a lapse in contraceptive coverage. Following this introductory section, the background section discusses the contraceptive usage and needs of American women, as well as the failure rates of the 2 contraceptive methods discussed in this paper. The background section also discusses the public impact and current trends, individual and public costs, and outcomes of unintended pregnancies in the United States. A short discussion of the Healthy People 2020 objectives related to reducing unintended pregnancy and increasing use of contraception is also included in the background section. Next, in the methods section, we describe the methods and criteria used to gather the studies reviewed in this literature synthesis, followed by a description of the studies. In the following results section, we discuss the reasons given for discontinuation of hormonal contraceptives, as well as the rates of discontinuation. In this section, we discuss each method reviewed in this synthesis, ordered by popularity of use in the United States: oral contraception (combined and progestin-only), intrauterine devices (hormonal and copper), injectable contraception (depot medroxyprogesterone [DMPA] and combined), vaginal ring, patch, and implant. This section also includes a discussion of demographic factors that are associated with contraceptive discontinuation: age, intimate partner violence and reproductive coercion, and socioeconomic status and ethnicity. The following discussion section includes a discussion of the factors that may be positively or negatively associated with discontinuation in specific methods. This is followed by a discussion of client-provider interactions and counseling, which is shown to significantly improve contraceptive continuation. Lastly, this paper concludes with a discussion of limitations and directions for future research, and the public health significance of this topic. 3 2.0 BACKGROUND The Guttmacher Institute points out that the average number of children desired by American families is two; as the average reproductive lifespan is considered to be roughly ages 15-44, women spend at least three decades of their lives trying to avoid pregnancy (Guttmacher Institute, 2000). It is likely that the length of time that women want to avoid pregnancy is growing as marriage and childbearing are becoming increasingly delayed, leading to greater use of contraceptives. The Guttmacher Institute (2013) also estimates that in 2010, there were 66 million American women of reproductive age (13-44). More than half of these women (37 million) were sexually active and fertile, but were not and did not want to become pregnant; therefore, 37 million women were in need of contraceptives. The CDC contends that the need for contraception among sexually active women may be even greater; they estimated that 43 million of these women of childbearing age (70% of the total) are sexually active and do not want to become pregnant, but could if they do not use contraception or their contraception fails (Jones, Mosher, & Daniels, 2012). Hormonal contraception may be preferred over sterilization by a majority of sexually active couples due to its reversibility, and over barrier methods due to hormonal contraceptives’ greater reliability in preventing pregnancy. Another important additional consideration that increases 4 couples’ preference for hormonal methods is that use does not interrupt sexual intercourse. Contraceptive use is generally widespread among sexually active couples in the United States. Approximately 99% of sexually active women have used at least one contraceptive method (Daniels, Mosher, & Jones, 2013), and it is estimated that 62% are using a method at any given time (Jones, Mosher, & Daniels, 2012). Of women who have used at least one method, approximately 80% have used oral contraceptives (Daniels, Mosher, & Jones, 2013), while the popularity of other hormonal methods is increasing. For instance, the rate of women who had ever used injectable contraceptives increased from 4.5% in 1995 to 23% by 2010, while the rate of women who had ever used the contraceptive patch increased from <1% in 2002 to 10% by 2010 (Jones, Mosher, & Daniels, 2012).1 Table 1 shows the prevalence of hormonal contraceptive methods used in the United States in 2010, as estimated by the Guttmacher Institute, with male and female sterilization, male condoms, and no method included for comparison’s sake. 1Depot medroxyprogesterone, an injectable contraceptive, was approved by the FDA in 1992 and the patch did not come on the market until early in the 2000s. 5 Table 1. Choice of contraceptive methods among US women in 2010, listed by popularity Method # of users, by thousands No method Oral contraceptive (combined and progestin-only) Female sterilization (tubal ligation) Male condom Male sterilization (vasectomy) Intrauterine device (copper & hormonal) Injectable (depot medroxyprogesterone & combined) Vaginal ring Contraceptive patch Implant % of all women 15-44 % of contraceptive users, overall 23,360 10,540 37.8 17.1 -27.5 10,200 6,280 3,860 2,140 16.5 10.2 6.2 3.5 26.6 16.3 10.0 5.6 1,450 2.4 3.8 830 290 180 1.3 0.5 0.3 2.2 0.7 0.5 Source: Guttmacher Institute. (2013). Contraceptive use in the United States. Retrieved from http://www.guttmacher.org/pubs/fb_contr_use.html. When used correctly and consistently, hormonal contraceptives are extremely effective in preventing pregnancy; in fact, some are more reliable than male or female sterilization. For instance, implants have a 0.05% failure rate with both perfect and typical use, meaning that 1 in 2000 users will become pregnant over one year, while male sterilization has double the implant failure rate at .10% with perfect use (1 in 1000) and triple the implant failure rate of 0.15% with typical use (1 in 666) (see Table 1 for failure rates). Compared to implantable contraceptives and male sterilization, female sterilization (tubal ligation) is much less reliable, with a perfect use failure rate of 0.5% with typical and perfect use (1 in 200); in other words, ten times the failure rate of implants, and at least three times the failure rate of male sterilization). Table 2 (below) shows the proportion of women who will become pregnant over one year, sorted by method, with male and female sterilization, male condoms, and no method included for 6 comparison’s sake. It is clear from the discrepancy between perfect use and typical use that for most hormonal methods that require a timed regimen, method failure or user failure is extremely common. Table 2. Failure rates of various types of contraception over one year, by method, listed by effectiveness of perfect use Method Perfect use % Implant 0.05 Male sterilization (vasectomy) 0.10 Intra-uterine device (hormonal) 0.20 Injectable (depot medroxyprogestrone acetate 0.20 and combined) Oral contraceptive (progestin-only, combined) 0.30 Contraceptive patch 0.30 Vaginal ring 0.30 Female sterilization (tubal ligation) 0.50 Intra-uterine device (copper) 0.60 Male condom 2.00 No method 85.0 (Types of contraception not included in this review are italicized) Typical use % 0.05 0.15 0.20 6.00 9.00 9.00 9.00 0.50 0.80 18.0 85.0 Source: Guttmacher Institute. (2013). Contraceptive use in the United States. Retrieved from http://www.guttmacher.org/pubs/fb_contr_use.html. Family planning is not only a personal issue, but also has public impact. It has been estimated that the total public expenditures for family planning services in 2010 were $2.37 billion, with Medicaid accounting for 75% of the total ($1.8 billion) (Sonfield & Gold, 2012). With the help of these publicly funded family planning services, 2.2 million unintended pregnancies were avoided, which would have resulted in 1.1 million unintended births and 760,000 abortions in 2010 (Guttmacher Institute, 2010). Avoiding unintended pregnancies saved a total of $7.6 billion in public expenditures; the Guttmacher Institute estimates that for every $1.00 invested in family planning services, 7 $5.68 was saved in Medicaid expenditures that would have been used to support these unintended pregnancies (2010). 2.1 UNINTENDED PREGNANCY – TRENDS, COSTS, AND OUTCOMES Unintended pregnancy is a widespread and highly visible public health issue in the United States, despite public prevention efforts. In 2008, 3.4 million pregnancies, or roughly half of the 6.6 million total pregnancies, in the United States were unintended. and the rate of unintended pregnancies increased from 2001 to 2008 while the rate of intended pregnancies decreased from 52% to 49% in that same period (Finer & Zolna, 2014). More than half of all American women have or will become pregnant without having intended to do so by the age of 45, and more than three in 10 will have had an abortion (Jones & Kavanaugh, 2011). Another estimate found that about 37% of births in the United States were unintended at conception (Mosher, Jones, & Abma, 2012). Each year, about 5% of women of reproductive age have an unintended pregnancy; 40% of unintended pregnancies in 2008 ended in abortion (Finer & Zolna, 2014). Approximately 40% of women who experienced an unintended pregnancy between 1998 and 2002 were using contraception (Mosher, Jones, & Abma, 2012). Of the 60% who were not using contraception at the time of conception, 36% stated that they believed they could not get pregnant, 23% said that they “really didn’t mind if they got pregnant” (p11), 17% did not expect to have sex, 14% did not use contraception because they were concerned about the side effects of birth control, 8% stated that their 8 partner did not want to use birth control, and 5.3% stated that their partner did not want them to use birth control (Mosher, Jones, & Abma, 2012). Unintended pregnancy is a pressing public health issue in the United States, because it is a far too common and costly event, at an individual/personal level and at the public level. It is worth noting that the rate of unintended pregnancy in the United States is significantly higher than that of many other developed countries (Singh, Sedgh, & Hussain, 2010). The estimated public cost of unintended pregnancies in 2008 alone was approximately $12.5 billion in government expenditures (Trussell, 2007). (For comparison’s sake, the CDC’s 2008 budget was about $9.2 billion [CDC, 2008].) As stated above, 60% of the unintended pregnancies that occurred in 2008 ended in birth; of these pregnancies, 65% were paid for by public insurance programs, compared to 48% of all pregnancies and 36% of intended pregnancies (Sonfield & Kost, 2013). Sonfield and Kost (2013) also found that a publicly funded unintended pregnancy cost $12,613 for prenatal care, labor and delivery, postpartum care, and one year of care for the infant. Publicly funded family planning services are a cost-effective and efficient way to prevent these unintended pregnancies: without these programs, it has been estimated that the rate of unintended pregnancies and abortions would be nearly 2/3 higher overall (Sonfield & Kost, 2013). Sonfield and Kost (2013) estimate that public spending on these family planning programs totaled $1.9 billion in 2008, resulting in $7 billion in savings from preventing unintended pregnancies and the resulting births. Furthermore, the Guttmacher Institute (Sonfield & Kost, 2013) has estimated that without public family planning programs, the public cost of unintended pregnancies would have been $12.7 9 billion, more than that of the unintended pregnancies that did occur, and doubling the potential overall cost to more than $25 billion in 2010. On an individual level, unintended pregnancy is associated with negative social and health outcomes. Mothers whose pregnancies are unintended are more likely to delay seeking prenatal care or to receive inadequate prenatal care, which greatly increases the likelihood of negative health outcomes (Dibaba, Fantahun, & Hindin, 2013; Mayer, 2008). Prenatal care includes screening for congenital or birth conditions, maternal health screening, especially for concurrent health issues such as sexually transmitted diseases and alcohol, tobacco, and drug use, breastfeeding preparation, parenting skills preparation, birth preparation and more. The Maternal and Child Health Bureau at the Human Resources and Services Administration estimates that babies born to mothers who received no prenatal care are three times more likely to be low birthweight and five times more likely to die (Maternal and Child Health Bureau, n.d.). Low birthweight is well-known as a significant risk factor for neonatal mortality. Another study found that unintended pregnancies that were reported during the first trimester were more than twice as likely to result in neonatal mortality (Bustan & Coker, 1994). Unintended pregnancy is also linked to a higher likelihood of alcohol and tobacco use during pregnancy (DePersio, Chen, Blose, & Lorenz, 1992), as well as increased intimate partner violence towards the mother (Gazmararian et al., 1995). Delayed psychosocial development and emotional disturbances in children have also been linked to unintended pregnancies (Kubicka et al., 1995), as well as lower educational attainment by the child (Myhrman, Olsen, Rantakallio, & Laara, 1995). However, it is important to keep in mind that many of these outcomes may be confounded by poverty. 10 In 2008, the rate of unintended pregnancy among women whose incomes were at or below the federal poverty line (137/1,000) was more than five times that of women at the highest income level (26/1,000); likewise, women who did not complete high school had the highest unintended pregnancy rate across all educational levels (Finer & Zolna, 2014). Several of Healthy People 2020’s family planning objectives are related to contraceptive use and the reduction of unintended pregnancy. For this essay, the two most salient objectives are FP-1 and FP-6 (Healthy People 2020, 2014). FP-1’s objective is to increase the proportion of intended pregnancies overall from 51% (2002 statistic) to 56%. Data from 2006 on unintended pregnancy showed an increase of .3% (51.0 to 51.3) compared to the 2002 data; this is not a statistically significant increase, nor is it an improvement. FP-6’s objective is to increase contraceptive use by females at risk of unintended pregnancy or their partners, at most recent sexual intercourse. Healthy People 2020 data reported for 2006-2010 show that 83.3% of females at risk of unintended pregnancy or their partners used contraception at the most recent sexual intercourse; FP-6 aims to increase this proportion by 10% to 91.6%. 11 3.0 METHODS Although family planning and contraception are both important public health topics, there is a noticeable lack of literature that reports and analyzes patients’ selfreported reasons for discontinuation of contraception. Discontinuation of contraception puts women at risk of unintended pregnancy, especially if another reliable and effective method of contraception is not adopted immediately after discontinuation. This paper seeks to identify and describe the reasons for women’s discontinuation of their hormonal contraceptives, which can then be addressed by public health practitioners and women’s healthcare providers. 3.1 DESCRIPTION OF STUDIES All searches were completed between May 1 and May 7, 2014, with the following search phrase: “contraceptive compliance OR contraceptive discontinuation OR contraceptive continuation.” Google Scholar yielded 34,200 results, Science Direct yielded 7,465 results, PubMed yielded 2,939 results, GenderWatch yielded 2,513 results, Web of Science yielded 2,162 results, Medline yielded 2,162 results, and Women’s Studies International yielded 373 results. All of the databases listed were 12 accessed through the University of Pittsburgh’s Library Services, with the exceptions of Google Scholar and Science Direct. Many of the results were excluded although they fit the search parameters due to lack of quantitative information regarding patients’ reasons for discontinuation. Figure 1 describes the search parameters, number of search results by database, reasons for exclusion of some studies from this review, and the number of studies included by contraceptive type. Some studies included several types of contraception in their analyses. Figure 1. Results of literature search 13 Many of the studies appearing in the database searches were not included because they discussed use of contraception but did not include method-specific rates of discontinuation, which was one of the criteria for inclusion in this review. They may have included qualitative data on discontinuation, but this review primarily examines quantitative data, i.e. rates of discontinuation. Other criteria for selecting these articles included: (1) a sample size of greater than 100; (2) publication date within the last 20 years (i.e. later than 1994); (3) evaluation of contraceptives to prevent pregnancy, rather than explicitly treating other gynecological disorders such as pre-menstrual dysphoric disorder or endometriosis. International studies were acceptable, while barrier methods were not evaluated in this review. Certain studies measured use in cycles rather than months; cycles were coded as months in the literature summary tables, since the typical menstrual cycle approximately corresponds with a month. For the purposes of this literature synthesis, 58 research articles published in peer-reviewed journals were reviewed. All articles included reported discontinuation rates of various hormonal contraceptives and patients’ reasons for discontinuing their hormonal contraceptive. The hormonal contraceptives included in this review are: (1) oral contraceptives, including combined pills and progestin-only pills (many brand names for both); (2) intrauterine devices (IUDs), including hormone-releasing systems (brand name Mirena) and copper systems (brand name Paragard); though copper systems are technically not hormonal contraception, they are often grouped with hormonal contraceptives because they are effective, long-lasting, and reversible; (3) injectable contraceptives, including depot medroxyprogesterone acetate (DMPA; brand name Depo-Provera) and combination injectables (brand name Lunelle); (4) vaginal ring 14 contraceptives (brand name NuvaRing); (5) contraceptive adhesive dermal patches (brand name Ortho-Evra); and (6) contraceptive upper arm implants (brand names Implanon, Nexplanon, Norplant). Some of the 58 articles reviewed more than one type of contraceptive; not all articles listed the reasons for discontinuation of drugs. 15 4.0 4.1 RESULTS REASONS GIVEN FOR DISCONTINUATION OF HORMONAL CONTRACEPTIVES There was very little consistency between studies for typifying or naming the reasons given by study subjects for discontinuation of the study medication. In some studies, no reasons were given, while in others the reason was brief and non-specific (e.g., “side effects” rather than “menorrhagia”). By far, the most common reason given for discontinuation was discomfort with the side effects associated with hormonal contraception. Other reasons for discontinuation common to all the methods were that the contraceptive was no longer needed, either due to pregnancy (which we may assume meant failure of the method or pregnancy that occurred before the contraceptive regimen), a desire for pregnancy, or a change in sexual habits (e.g. no longer having sex). These reasons for discontinuation cannot necessarily be addressed by public health or healthcare practitioners. Reasons for discontinuation given in the studies were grouped as follows by this author (Figure 2): 16 17 Figure 2. Reasons given for discontinuation of contraceptives given in studies reviewed 4.2 DISCONTINUATION OF HORMONAL METHODS Fifty-eight articles that reviewed discontinuation of hormonal contraceptives and reasons for discontinuation were identified and reviewed. The studies differed widely in the contraceptives covered, time period studied, and reasons given for discontinuation. Overall, and overwhelmingly, the most common reason for discontinuing any method was side effects. Many studies did not elucidate “side effects,” but of those that did, the side effects that were found to be most off-putting were irregular or increased bleeding and pain. 18 4.2.1 ORAL CONTRACEPTION (COMBINED AND PROGESTIN-ONLY) Twenty eight articles that reviewed discontinuation of oral contraceptives were identified and reviewed. The rates of and reasons for discontinuation given in these studies are summarized below in Tables 3, 4, and 5, and Figure 3. By far the most popular contraceptive method in the United States and world-wide, oral contraceptives overall displayed a disappointing rate of continuation, compared to other methods. Only 13 of the 28 total studies listed reasons for discontinuation; most often, the reason was side effects. Other common reasons included no further need for contraception, user dissatisfaction, access issues, and failure of the method. Other reasons for discontinuation that were given are listed in Table 4. These were widely variable, ranging from vague and non-specific (e.g., “Patient preference” or “Other”) to the very specific (e.g., “Unacceptable vaginal bleeding”). Table 3. Summary of oral contraceptive studies reviewed, with most common reason given for discontinuation Study Time (months) Discontinuation rate Most common reason for discontinuation Range: 8.0% -88.0% Rosenberg & Waugh, 1998 Khan, 2001 Ali & Cleland, 2010 6 27.7% Side effects 6 6 43.0% 48.1% Westhoff et al., 2007 Rakhshani & Mohammadi, 2004 Suhonen et al., 2004 Lete et al., 2012 Raine et al., 2011 Ahrendt et al., 2006 Oddsson et al., 2005 6 12 57.0% 8.0% Side effects Side effects and medical reasons or health concerns Access issues User dissatisfaction 12 12 12 13 13 27.0% 54.1% 66.9% 25.4% 29.8% Side effects Side effects Side effects Side effects, adverse event Side effects, adverse events 19 Table 3 continued. Colli et al., 1999 24 42.0% Contraceptive no longer needed Side effects Rosenberg, Waugh, 24 51.0% & Meehan, 1995* Rosenberg, Waugh, 24 72.0% Side effects & Meehan, 1995** Rosenberg, Waugh, 24 73.0% Side effects & Meehan, 1995*** Rosenberg, Waugh, 24 82.0% Side effects & Meehan, 1995**** Rosenberg, Waugh, 24 88.0% Side effects & Meehan, 1995***** Moreau, Cleland, & Lifetime 29.2% Side effects Trussell, 2007 *Italy; **United Kingdom; ***Denmark; ****Portugal; *****France Continuation rates were highly variable, ranging from 8.0% after 12 months (Rakhshani & Mohammadi, 2004) to 88.0% after 12 months (Zibners, Cromer, & Hayes, 1999) and 24 months (Rosenberg, Waugh, & Meehan, 1995). Rosenberg, Waugh, and Meehan (1995) also found that the occurrence of multiple side effects greatly increased the likelihood of discontinuation: one side effect increased the risk of discontinuation by 50%, two side effects by 220%, and three side effects by 320%. As noted above, only 13 of the 28 studies reviewed listed patients’ reasons for discontinuation of their oral contraceptive. The 15 studies that did not list reasons for discontinuation are summarized below in Table 5. A visual representation of the discontinuation rates given in all 28 studies is given in Figure 3, which charts discontinuation rates by time (months) and percentage. There does not seem to be any pattern in rates of discontinuation, which may be attributed to several factors such as a wide variety of oral contraceptive formulations (see Discussion). 20 Table 4. Other reasons for discontinuation of oral contraceptive Reason for discontinuation Studies in which patients reported reason for discontinuation Ahrendt et al., 2006 Colli et al., 1999 Ahrendt et al., 2006 Khan, 2001 Lete et al., 2012 Raine et al., 2011 Rosenberg & Waugh, 1998 Westhoff et al., 2007 Ali & Cleland, 2010 Khan, 2001 Lete et al., 2012 Raine et al., 2011 Rosenberg & Waugh, 1998 Ahrendt et al., 2006 Ali & Cleland, 2010 Khan, 2001 Lete et al., 2012 Moreau, Cleland, & Trussell, 2007 Lete et al., 2012 Moreau, Cleland, & Trussell, 2007 Raine et al., 2011 Rosenberg & Waugh, 1998 “Not willing to cooperate” “Patient preference” “Other” Contraceptive no longer needed: Change in sexual habits Pregnancy desired Failure of method User dissatisfaction: Did not like changes in menstrual period Lack of protection against STIs Method decreased sexual pleasure Poor cycle control Too difficult to use Too messy to use Worried about effectiveness in preventing pregnancy Partner dissatisfaction Ahrendt et al., 2006 Khan, 2001 Moreau, Cleland, & Trussell, 2007 Access issues Khan, 2001 Insufficient supply Moreau, Cleland, & Trussell, 2007 Too difficult to obtain Raine et al., 2011 Too expensive Rosenberg & Waugh, 1998 Medical reasons of health concerns Ahrendt et al., 2006 Concern about hormones Khan, 2001 Worried about side effects Moreau, Cleland, & Trussell, 2007 Raine et al., 2011 Rosenberg & Waugh, 1998 Side effects Ahrendt et al., 2006 Unacceptable vaginal bleeding Westhoff et al., 2007 21 Table 5. Summary of oral contraception articles reviewed, with no reason for discontinuation given in study Study Time (months) Discontinuation rate Range: 13.0% - 88.0% Kalagian et al., 1998 Murphy & Brixner, 2008 Moreau et al., 2009. Vaughn et al., 2008 Gilliam et al., 2010 Rosenstock et al., 2012* Rosenstock et al., 2012** Rosenstock et al., 2012*** Kalagian et al., 1998 Moreau et al., 2009. Trussell, 2011 O'Neil-Callahan et al., 2013 Melhado, 2011 Peipert et al., 2011 Stuart et al., 2013 Vaughn et al., 2008 Barden-O’Fallon et al., 2011 Zibners, Cromer, & Hayes, 1999 Ali & Cleland, 1999 Moreau et al., 2009. O'Neil-Callahan et al., 2013 Rosenberg, Waugh, & Meehan, 1995 Moreau et al., 2009. Moreau et al., 2009. *Age <26; **Age 20-25; *** Age 14-19 3 3 6 6 6 12 12 12 12 12 12 12 12 12 12 12 12 12 24 24 24 24 36 48 22 13.0% 45.0% 19.6% 31.1% 71.0% 46.1% 48.4% 53.3% 23.0% 30.7% 33.0% 41.0% 44.0% 44.9% 47.0% 47.4% 48.9% 88.0% 40.7% 49.0% 56.9% 72.0% 59.9% 68.5 Discontinuation rates of oral contraceptives, by time (months) and percentage 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 0 3 6 9 12 15 18 21 24 *Figure does not include Moreau, Cleland, & Trussell (2007), which provided a lifetime discontinuation percentage Figure 3. Discontinuation rates of oral contraception, by time (months) and percentage 23 4.2.2 INTRAUTERINE DEVICES (HORMONAL AND COPPER) Seven studies identified reasons for discontinuation of hormonal intrauterine devices, and another seven identified reasons for discontinuation of copper devices. Ten studies were also identified that did not differentiate between the two types of systems. The rates of and reasons for discontinuation given in these studies are summarized below in Tables 6 (copper), 7 (hormonal), and 8 (type not given), and Figures 4 (copper), 5 (hormonal), and 6 (type not given). Often, studies were not clear or did not differentiate between hormone-releasing systems and copper systems. The hormonal intrauterine device (also called intrauterine system or IUS) was more popular than the copper device, due to fewer and/or less severe side effects. Table 6. Summary of copper intrauterine device articles reviewed Study Time (months) Discontinuation rate Range: 6.7% - 58.3% Sivin et al., 1997 6 Garbers et al., 2013 6 Sivin et al., 1997 12 Rosenstock et al., 2012* 12 O'Neil-Callahan et al., 2013 12 Peipert et al., 2011 12 Rosenstock et al., 2012** 12 Trussell, 2011 12 Rosenstock et al., 2012*** 12 O'Neil-Callahan et al., 2013 24 Lara-Torre et al., 2011 36 *Age >26; **Age 20-25; ***Age 14-19 6.7% 11.0% 11.9% 14.1% 14.9% 16.0% 17.5% 22.0% 24.4% 26.7% 58.3% 24 Discontinuation rates of copper intrauterine device, by time (months) and percentage 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 0 6 12 18 24 30 36 Figure 4. Discontinuation rates of copper intrauterine device, by time (months) and percentage Discontinuation ranged between 6.7% at six months (Sivin et al., 1997) to 58.3% at 36 months (Lara-Torre, Spotswood, Correia, & Weiss, 2011) for copper systems, and 9.2% at 12 months (Behringer, Reeves, Rossiter, Chen, & Schwarz, 2011) to 70.2% at 36 months (Lara-Torre et al., 2011) for hormonal systems. For studies that did not differentiate between the types, the discontinuation rate ranged from 10.2% at six months (Moreau, Bouyer, Bajos, Rodriguez, & Trussell, 2009) to 70.2% of ever-users (Modey, Aryeetey, & Adanu, 2014). It is notable that only studies of two copper IUD stated reasons for discontinuation (Lara-Torre et al., 2011; Peipert et al., 2011), and only four hormonal IUD studies did so as well (Behringer et al., 2011; Lara-Torre et al., 2011; Peipert et al., 2011; Suhonen et al., 2004) with side effects being the most common reason for discontinuation in all of the above. 25 Table 7. Summary of hormonal intrauterine device articles reviewed Study Time (months) Discontinuation rate Range: 9.2% - 32.6% Behringer et al., 2011 12 O'Neil-Callahan et al., 2013 12 Rosenstock et al., 2012* 12 Rosenstock et al., 2012** 12 Rosenstock et al., 2012*** 12 Trussell, 2011 12 Suhonen et al., 2004 12 Peipert et al., 2011 12 Behringer et al., 2011 24 O'Neil-Callahan et al., 2013 24 Lara-Torre et al., 2011 36 *Age 20-25; **Age <26; ***Age 14-19 9.2% 11.9% 13.2% 13.4% 19.4% 20.0% 20.0% 22.5% 15.1% 21.1% 32.6% Discontinuation rates of hormonal intrauterine device, by time (months) and percentage 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% 0 12 24 36 Figure 5. Discontinuation rates of hormonal intrauterine device, by time (months) and percentage Three studies that did not differentiate between the types of IUDs also identified the most common reasons: contraceptive was no longer needed (Colli et al., 1999); failure of method (expulsion) (Teal & Sheeder, 2012); and side effects (Tewari & Kay, 26 2006). All studies that further elaborated on side effects identified bleeding and/or cramping/pain (Peipert et al., 2011; Suhonen et al., 2004; Tewari & Kay, 2006). Two studies identified failure of the method as a reason for discontinuation (Lara-Torre et al., 2011; Teal & Sheeder, 2012), and two identified “contraceptive no longer needed” as a reason for discontinuation (Colli et al., 1999; Lara-Torre et al., 2011). Table 8. Summary of articles reviewed, intrauterine device (type not stated) Study Time (months) Discontinuation rate Range: 10.2% - 70.2% Moreau et al., 2009. Moreau et al., 2009. Rakhshani & Mohammadi, 2004 Tewari & Kay, 2006 Melhado, 2011 Barden-O'Fallon et al., 2011 Teal & Sheeder, 2012 Moreau, et al., 2009. Ali & Cleland, 1999 Colli et al., 1999 Moreau et al., 2009. Rakhshani & Mohammadi, 2004 Moreau et al., 2009. Moreau, Cleland, & Trussell, 2007 Modey, Aryeetey, & Adanu, 2014 6 12 12 12 12 12 12 24 24 24 36 36 48 Lifetime Lifetime 27 10.2% 15.0% 18.0% 23.0% 31.0% 37.9% 45.0% 26.2% 37.3% 44.0% 36.4% 40.0% 43.4% 36.4% 70.2% Discontinuation rates of intrauterine device, type not stated, by time (months) and percentage 50.0% 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% 0 6 12 18 24 30 36 42 48 *Figure does not include the 2 studies (Moreau, Cleland, & Trussell, 2007; Modey, Aryeetey, & Adanu, 2014) which provided lifetime estimates for discontinuation Figure 6. Discontinuation rates of intrauterine device, type not stated, by time (months) and percentage Intrauterine devices were second only to the implant in terms of highest rates of continuation. Other commonly given reasons for discontinuation included failure of method (including expulsion or ectopic pregnancy) and no further need for contraception. 4.2.3 INJECTABLE CONTRACEPTION (DEPOT MEDROXYPROGESTERONE [DMPA] AND COMBINED) Fifteen studies reviewing injectable depot medroxyprogesterone (DMPA) contraceptives were identified, in addition to six that either identified a combined injectable or did not identify a type at all The rates of and reasons for discontinuation 28 given in these studies are summarized below in Tables 9, 10, and 11, and Figures 7 and 8. Side effects of menstrual irregularities or disturbances were listed as the most common reason for discontinuation, when a reason was given. Rates of discontinuation for injectables were especially high; all of the studies identified had discontinuation rates of at least 33%. The highest rate of discontinuation was 88.6% at 12 months (Raine et al., 2011). Table 9. Summary of injectable contraceptive (DMPA) articles reviewed, with most common reason for discontinuation Study Time Discontinuation (months) rate Polaneczky & Liblanc, 1998 Rakhshani & Mohammadi, 2004 Paul, Skegg, & Williams, 1997 Davidson et al., 1997 Polaneczky & Liblanc, 1998 6 12 52.0% 47.0% Most common reason for discontinuation, if given Side effects User dissatisfaction 12 12 12 53.0% 58.0% 73.0% Side effects Side effects Side effects Raine et al., 2011 Colli et al., 1999 Rakhshani & Mohammadi, 2004 Moreau, Cleland, & Trussell, 2007 12 24 36 88.6% 48.0% 56.0% Side effects "Patient preference" User dissatisfaction Lifetime 43.3% Side effects Range: 43.4% - 88.6% Five studies identified reasons for discontinuation other than side effects as the most common reason. Moreau, Cleland, and Trussell (2007) found the following reasons for discontinuation of DMPA: access issues (too expensive, too difficult to obtain), user dissatisfaction (too difficult to use, too messy to use, worried about effectiveness in preventing pregnancy, lack of protection against STIs, method decreased sexual pleasure), partner dissatisfaction, medical reasons or health concerns 29 (worried about side effects, other health problems, doctor’s advice), failure of method, and “other.” Table 10. Summary of injectable contraceptive (DMPA) articles reviewed, with no reason for discontinuation given in study Study Time (months) Discontinuation rate Range: 33.0% - 77.0% Hubacher et al., 2000 O'Neil-Callahan et al., 2013 Rosenstock et al., 2012 Peipert et al., 2011 Trussell, 2011 Rosenstock et al., 2012 Hubacher et al., 2000 Rosenstock et al., 2012 Zibners, Cromer, & Hayes, 1999 Beksinksa, Rees, & Smit, 2001 Westfall, Maine, & Barnard, 1996 O'Neil-Callahan et al., 2013 6 12 12 12 12 12 12 12 12 33.0% 42.5% 42.9% 43.5% 44.0% 46.6% 49.0% 52.7% 55.0% 12 12 58.0% 77.0% 24 62.0% 30 Discontinuation rates of injectable DMPA, by time (months) and percentage 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 0 6 12 18 24 30 36 Figure 7. Discontinuation rates of injectable DMPA, by time (months) and percentage Raine et al. (2011) found the following reasons for discontinuation of DMPA: access issues, contraceptive no longer needed (“pregnancy-related” or pregnancy desired), user dissatisfaction (too difficult to use), medical reasons or health concerns, and “other” (unknown). Colli et al. (1999) found that the contraceptive was no longer needed, while Hubacher et al. (2000) found that side effects (weight gain, other), contraceptive no longer needed (pregnancy desired), failure of method, medical reasons or health concerns, and “other” were reasons given for discontinuation by patients. Lastly, Polaneczky and Liblanc (1998) found that side effects (weight gain) and access issues (appointment noncompliance) were other reasons given for discontinuation. Only one study (Moreau, Cleland, & Trussell, 2007) reviewed a combined injectable contraceptive (Lunelle); no reason was given for discontinuation, 31 which is not surprising as the drug is no longer available in the United States due to concerns about its effectiveness in preventing pregnancy. Table 11 below lists the discontinuation rates for various studies in which the type of injectable contraceptive was not given, in addition to the one study on Lunelle. Table 11. Summary of injectable contraceptive (combined or type not stated) articles reviewed Study Vaughn et al., 2008 Barden-O’Fallon et al., 2011 Melhado, 2011 Vaughn et al., 2008 Ali & Cleland, 1999 Moreau, Cleland, & Trussell, 2007 Modey, Aryeetey, & Adanu, 2014. Time (months) Discontinuation Type Rate 6 12 12 12 24 Lifetime 34.5% 43.6% 50.0% 55.3% 40.5% 33.1% [not stated] [not stated] [not stated] [not stated] [not stated] [combined] Lifetime 50.1% [not stated] Range: 33.1%-55.3% 4.2.4 VAGINAL RING Seventeen studies reviewing vaginal ring contraceptives were identified. The rates of and reasons for discontinuation given in these studies are summarized below in Tables 12 and 13, and Figure 9. As with all the other methods reviewed, side effects were the most common reason identified for discontinuation. Rates of discontinuation were high compared to other methods; the lowest rate of discontinuation was 15.7% at three months (Roumen, op ten Berg, & Hoomans, 2006), while the highest was 76.5% at 12 months (Sivin et al., 1997). Five of 15 studies reported a discontinuation rate of above 50%, and nine had above a 40% discontinuation rate. Two studies identified 32 “nonmedical” or “nondevice” reasons for discontinuation (Dieben, Roumen, & Apter, 2002; Novak et al., 2003). Table 12. Summary of vaginal ring articles reviewed, with most common reason reason for discontinuation Study Time period (months) Discontinuation rate Most common reason for discontinuation Roumen, op ten Berg, & Hoomans, 2006 Brucker, Karck, & Merkle, 2008 Oddsson et al., 2005 3 15.7% Side effects 6 22.0% Side effects 12 29.1% Roumen et al., 2001 12 29.6% Dieben, Roumen, & Apter, 2002 Lete et al,., 2012 Raine et al.,2011 Novak et al.,2003 12 35.4% Side effects, adverse events Side effects, adverse events "Nonmedical reasons" 12 12 13 57.7% 70.0% 25.4% Ahrendt et al., 2006 13 29.8% Range: 15.7%-70.0% Side effects Side effects "Nonmedical, nondevice reasons" Side effects, adverse events Several studies listed reasons for discontinuation other than side effects, that were not the most common reason. Lete et al. (2011) identified these: “other,” contraceptive no longer needed (change in sexual habits or pregnancy desired), user dissatisfaction (poor cycle control), and failure of method. Ahrendt et al. (2006) identified the following reasons: “other,” partner dissatisfaction (felt ring during intercourse), side effects (unacceptable vaginal bleeding), failure of method, contraceptive no longer needed, and “not willing to cooperate”. Raine et al. (2011) identified the following 33 reasons: user dissatisfaction (too difficult to use), access issues (too expensive, too difficult to obtain), contraceptive no longer needed (pregnancy desired or “pregnancyrelated”), medical reasons or health concerns, and “other” (unknown). Roumen, op ten Berg, and Hoomans (2006) identified partner dissatisfaction (felt ring during intercourse) and “other” as reasons. Novak et al. (2003) identified side effects (adverse events not necessarily related to study medication) as another reason for discontinuation. Table 13. Summary of vaginal ring articles reviewed, with no reason for discontinuation given in study Study Time (months) Discontinuation rate Range: 22.2%-76.5% Merki-Feld & Hund, 2010 4 Sivin et al., 1997 6 Gilliam et al., 2010 6 Trussell, 2011 12 O'Neil-Callahan et al., 2013 12 Peipert et al., 2011 12 Rosenstock et al., 2012* 12 Rosenstock et al., 2012** 12 Stuart et al., 2013 12 O'Neil-Callahan et al., 2013 12 Rosenstock et al.,2012*** 12 Sivin et al., 1997 12 O'Neil-Callahan et al., 2013 24 *Age >26; **Age 20-25; *** Age 14-19 22.2% 47.5% 74.0% 33.0% 44.0% 45.8% 46.9% 47.8% 49.0% 44.0% 69.0% 76.5% 58.9% 34 Figure 8. Discontinuation rates of vaginal ring contraceptive, by time (months) and percentage 4.2.5 PATCH Nine studies were identified that reviewed discontinuation rates of the contraceptive patch. The rates of and reasons for discontinuation given in these studies are summarized below in Table 14. The small number of studies available is not surprising due to the patch’s status as the second-least popular hormonal method of contraception in the United States. Overall, rates of continuation were highly variable, ranging from 19.8% in all women who had ever used the method (Moreau, Cleland, & Trussell, 2007) to 87.1% after 12 months (Raine et al., 2011). While side effects were 35 the most common reason for discontinuation, user dissatisfaction was also common as was no longer needing contraception. Table 14. Summary of patch contraceptive articles reviewed Study rate Time period (months) Discontinuation Range: 19.8% - 87.1% Trussell, 2011 12 Peipert et al., 2011 12 O'Neil-Callahan et al., 2013 12 Stuart et al., 2013 12 Rosenstock et al., 2012* 12 Rosenstock et al., 2012** 12 Rosenstock et al., 2012*** 12 Lete et al., 2012 12 Raine et al., 2011 12 O'Neil-Callahan et al., 2013 24 Moreau, Cleland, & Trussell, 2007 Lifetime *Age 14-19; **Age >26; ***Age 20-25 33.0% 50.1% 50.4% 58.0% 59.1% 59.3% 60.3% 74.0% 87.1% 60.1% 19.8% Only two studies (Lete et al., 2012; Raine et al., 2011) listed reasons for discontinuation; both found that the most common reason was side effects. In addition to side effects, these two studies also found other reasons for discontinuation: “other,” contraceptive no longer needed (pregnancy desired or change in sexual habits), user dissatisfaction (poor cycle control), and failure of method (Lete et al., 2012). Raine et al. (2011) found the following reasons for discontinuation: user dissatisfaction (too difficult to use), “pregnancy-related,” access issues, contraceptive no longer needed (pregnancy desired or change in sexual habits), medical reasons or health concerns, and “other” (unknown). 36 4.2.6 IMPLANT Fourteen studies were identified that reviewed the discontinuation rates of contraceptive implants. The rates of and reasons for discontinuation given in these studies are summarized below in Table 15 and Figure 10. Several types of implants were studied, including levonorgestrel rods (generic and Norplant) and etonorgestrel (Implanon). Of all the hormonal methods reviewed in this paper, implants were the most likely to be continued. Only five studies calculated discontinuation rates above 30%. Eleven of the studies showed discontinuation rates below 20%, and the lowest rate of discontinuation was 3.5% at six months (Peers, Stevens, Graham, & Davey, 1996). Table 15. Summary of implant contraceptive articles reviewed, with most common reason for discontinuation Study (and type of implant, if identified) Time (months) Peers et al., 1996 [Norplant] Kalmuss et al., 1996 Croxatto et al., 1999 Lakha & Glasier, 2006 Rakhshani & Mohammadi, 2004 [levonorgestrel rod] Peers et al., 1996 [Norplant] Rosenstock et al., 2012* Trussell, 2011 [Implanon] O'Neil-Callahan et al., 2013 Peipert et al., 2011 Sivin et al., 1998a Rosenstock et al., 2012** Zibners, Cromer, & Hayes, 1999 Rosenstock et al., 2012*** 6 6 6 6 3.5% 7.6% 10.0% 11.0% Most common reason for discontinuation, if given Side effects Side effects Side effects Side effects 12 14.0% Side effects 12 12 12 12 12 12 12 14.8% 15.6% 16.0% 16.6% 16.7% 17.3% 17.8% Side effects 12 18.0% 12 19.9% 37 Discontinuation rate Range: 3.5%-41.0% Side effects Side effects Table 15 continued. Croxatto et al., 1999 12 Lakha & Glasier, 2006 12 Sivin et al., 1998a 24 Croxatto et al., 1999 24 O'Neil-Callahan et al., 2013 24 Lakha & Glasier, 2006 24 Rakhshani & Mohammadi, 36 2004 [levonorgestrel rod] Sivin et al., 1998a 36 Sivin et al., 1998b [Norplant] 36 Sivin et al., 1998b 36 [levonorgestrel rod] Modey, Aryeetey, & Adanu, Lifetime 2014 *Age >26; **Age 14-19; ***Age 20-25 20.0% 25.0% 20.0% 31.0% 31.5% 41.0% Side effects Side effects Side effects Side effects 22.0% Side effects 25.1% 28.9% Side effects Side effects 29.4% Side effects Side effects 40.3% Most studies identified side effects as the leading cause of discontinuation; most of the side effects were either irregular, prolonged, increased, or otherwise “unacceptable” bleeding, as well as headaches and changes in menstrual periods. Other reasons for discontinuation were given in two studies. Moreau, Cleland, and Trussell (2007) listed the following reasons: side effects (changes in menstrual periods), access issues (too expensive, too difficult to obtain), user dissatisfaction (too messy to use, too difficult to use, worried about effectiveness in preventing pregnancy, lack of protection against STIs, method decreased sexual pleasure), partner dissatisfaction, medical reasons or health concerns (worried about side effects, other health problems, or doctor’s advice), and “other.” 38 Discontinuation rates of implant contraceptives, by time (months) and percentage 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% 0 6 12 18 24 30 36 Figure 9. Discontinuation rates of implant contraceptives, by time (months) and percentage Kalmuss and colleagues (1996) listed the following reasons for discontinuation: side effects (implant site discomfort, implant site infection, weight change, mood changes, hair loss, chest pain), “other/unknown,” and “negative media reports” (the only article in this review to list that as a reason for discontinuation, for any type of hormonal contraceptive). 39 4.3 OTHER FACTORS ASSOCIATED WITH CONTRACEPTIVE DISCONTINUATION 4.3.1 AGE Age is a particularly relevant factor of concern for non-compliance or discontinuation due to the increased fertility of younger women. A 2008 study by Whitaker and Giliam estimated that 82% of pregnancies in females aged 15-19 were unintended. Rosenstock and colleagues (2012) found that continuation of contraception was negatively associated with age for all contraceptives studied. This conclusion is common to other studies as well. Mahdy and el-Zeiny (1999) found that women who were older and those with several children were significantly more likely to continue and comply with their oral contraceptive regimen. Archer, Cullins, Creasy and Fisher (2004) found that perfect dosing with the Patch was about equal across all age groups but compliance with oral contraceptives was significantly better in the above-30 age group compared to those aged 18-20. Another study reviewing intrauterine device use found that women aged 13-19 were more likely to request early discontinuation (Aoun et al., 2014). In a review of data from the 1995 National Survey of Family Growth, Trussell and Vaughn (1999) found that women over the age of 30 were 28% less likely to discontinue a reversible method of contraception. 40 4.3.2 INTIMATE PARTNER VIOLENCE AND REPRODUCTIVE COERCION While there is a lack of statistical data lacking regarding contraceptive discontinuation or noncompliance due to intimate partner violence or reproductive coercion, the issue is so pressing that the American College of Obstetricians and Gynecologists (ACOG) released a set of recommendations, guidelines, and suggestions for screening patients for intimate partner violence and reproductive coercion that could potentially lead to unintended pregnancies (ACOG, 2013). Use and continuation of hormonal contraception are important in situations such as these, since it is controlled by the woman (rather than male-controlled methods such as condoms) and much more reliable in preventing unwanted pregnancies than other methods. Miller et al. (2010) found that birth control sabotage and reproductive coercion were associated with unintended pregnancy in a population of women aged 16-29 seeking care in a public family planning clinic. The CDC's National Intimate Partner and Sexual Violence Survey 2010 Summary Report found that approximately 8.6% of women (about 10.3 million) reported ever having an intimate partner who tried to get them pregnant when they did not want to, or refused to wear a condom. About 4.8% had an intimate partner who tried to get them pregnant against their wishes. 4.3.3 SOCIOECONOMIC STATUS AND ETHNICITY Some evidence suggests that ethnicity and socioeconomic status are linked to discontinuation of contraception, and unintended pregnancy. Trussell and Vaughn’s review of data (1999) from the 1995 National Survey of Family Growth found that 41 Hispanic and Black women had a 28% higher rate of method-related discontinuation than their White counterparts, while low-income women had a 39% higher rate of method-related discontinuation than higher-income women. (Method-related reasons include side effects and user dissatisfaction, while non-method-related reasons may include no longer needing the contraceptive due to a change in sexual habits, access issues, or desire to become pregnant.) The groups that were most likely to experience an unintended pregnancy were minority women and poor and low-income women, as well as women aged 18-24 and cohabiting women (Finer & Zolna, 2014). Daniels, Mosher, and Jones (2013) found that Hispanic and Asian women were less likely than their Black and White counterparts to have ever used a highly effective reversible method of contraception. Stuart et al. (2013) found that Black women and women who received public assistance were more likely to discontinue oral contraception, the patch, or the ring. 42 5.0 5.1 DISCUSSION DISCONTINUATION OF CONTRACEPTION While this review of literature on hormonal contraceptive discontinuation has made clear that by far, side effects are the most common reason for discontinuation of contraception, there is little that public health practitioners and healthcare providers can do to physiologically prevent, mitigate, or eliminate side effects without discontinuing the method altogether. This is especially true of hormonal contraceptives because hormones interact differently with each individual to produce unpredictable side effects. It remains incumbent on the pharmaceutical industry to develop hormonal contraceptives that provide a better user experience, which would go a very long way in promoting contraceptive continuation. In addition to side effects, several studies named access issues such as expense or difficulty obtaining as one reason for discontinuation of contraception. With the introduction of the Affordable Care Act’s family planning mandate, requiring insurance plans to cover contraceptive methods at no out-of-pocket cost to patients (including the methods covered in this essay), as well as contraceptive counseling, it is possible that many financially-related access issues will be mitigated or eliminated. However, serious challenges remain to preventing unintended pregnancy through the use of hormonal 43 contraceptives, including access issues and the need to improve support from healthcare providers for contraceptive users, especially concerning issues of side effects. One possible explanation for the highly variable rates of continuation of oral contraception that were found in this review, is the different combinations and formulations of pills available, many of which are not named in the studies reviewed. The highly variable rates of discontinuation of oral contraception are particularly troubling, since over 1 million unplanned pregnancies in the United States each year are attributed to oral contraception non-compliance (mostly missing pills) or discontinuation (Black et al., 2010). It is possible that the relatively low rates of discontinuation of IUDs and implants could be due to the extensive counseling and examinations that must take place before insertion, guaranteeing a motivated and educated patient. In addition to this, the system can be placed and removed only by a trained practitioner during an appointment, and it is a “forgettable” method (Grimes, 2009). Another possible reason for the hormonal IUDs popularity is its potential to cause fewer side effects; since the effective dose for IUDs is lower because the hormone is released directly into the uterus, there is a lessened chance of side effects (Guttmacher, 2007). Other reasons may include marketing; for instance, Mirena was marketed as a birth spacer for parous women, so it is not surprising that desire for a pregnancy was a common reason for discontinuation. It is quite interesting that while implants are the least popular method of hormonal contraception, they were also the least likely to be discontinued after placement. 44 5.2 IMPLICATIONS FOR PRACTICE: CLIENT-PROVIDER INTERACTIONS AND COUNSELING The need to improve client-patient interactions and communication was underlined in Isaacs and Creinin’s 2003 study of pregnant women seeking in-office abortions, which found that 14% of the study population was using a less effective method of contraception than previously used, or no method at all, due to a communication failure. Thirty nine percent of the study population reported that they had their contraceptive method switched by the provider and were not offered an equally or more effective method; 22% were using an oral contraceptive, provided antibiotics (which negate the effect of oral contraceptives2) and were not warned to use a back-up method; 20% had their oral contraceptive stopped for a contraindication and were switched to a less effective method; 12% experienced difficulty obtaining emergency contraception or were incorrectly instructed on the use of emergency contraception; and 6% were prescribed a method that they did not want, while not being offered any other methods by the provider. Only one of the 77 women in the study who knew about emergency contraception and could have used it actually did use emergency contraception. It is clear that unintended pregnancy and abortion could have been 2It should be noted that more recent studies have found that broad speum antibiotics do not reduce the efficacy of oral contraceptives. (Archer & Archer, 2002; Helms et al., 1997.) 45 avoided in many of these cases if client-provider interaction had been tailored to the patients’ needs (Isaacs & Creinin, 2003). Tailored contraceptive health counseling is also useful for helping women select a method that they feel suits them, which improves contraceptive compliance and continuation. In a 2012 study, Garbers, Meserve, Kottke, Hatcher, and Chiasson created a computer-based contraceptive assessment module and individually tailored health materials that assessed clients’ contraceptive needs; one group received the assessment module and tailored materials, another group received the assessment module and generic materials, and the last group did not receive the special assessment module and only generic materials (control group). There was no significant difference between the group that received the module and generic materials and the control group that received only generic materials, but there was a significant difference between the group that received the special assessment module and tailored materials and the control group. Continuation of use and adherence to the contraceptive regimen were 95% and 86%, respectively, in the experimental group that received the special assessment module and tailored materials, while the control group continued use only 77% of the time and adhered to their regimen 69% of the time. Several studies show that high-quality client-provider interactions do improve contraceptive compliance and continuation. While the following studies discussed were not conducted in the United States, it remains clear that high-quality care is key to providers’ promotion of contraceptive continuation. RamaRao and colleagues (2003) report a positive association between quality of care and contraceptive use; the study assessed 1,728 women in the Philippines who were new users of family planning care. 46 Those women who received low-quality care at the time of contraceptive adoption had a 55% probability of using contraception at follow-up, compared to 67% of those who received high-quality care. In this study, quality of care was assessed using 24 indicators (Figure 10). The respondents reported that an average of 18.5 of the 24 indicators were assessed. The medium-quality level of care was defined as falling within one-half of a standard deviation of that mean; low-quality care was below one-half of the standard deviation from the mean, while high-quality care was above one-half of the standard deviation from the mean. Figure 10. 24 Indicators of Care Assessed by RamaRao et al., 2003 One 36-month study of 3,611 women using oral contraceptives, IUDs, injectables, and other non-hormonal methods of birth control in Bangladesh used seven 47 indicators of care: (1) was the fieldworker responsive to questions? (2) did the fieldworker appreciate the privacy of their client? (3) was the fieldworker helpful with problems? (4) was the fieldworker sympathetic to his/her client's needs? (5) did the fieldworker provide enough information about contraceptives? (6) did the fieldworker spend enough time with the client? and (7) did the fieldworker discuss and offer the client a choice of contraceptives? The results were positive when client-provider interactions were high-quality: women who reported a high level of care from their fieldworker were 27% more likely to adopt a method of contraception subsequently (after controlling for client characteristics), and 72% more likely to continue their method of contraception (Koenig, Hossain, & Whittaker, 2003). Similarly, a study in Senegal assessed five indicators of care: “whether the client was provided choice, had her needs assessed, was provided information, was treated well by the provider, and whether she was linked to future services” (Sanogo et al., 2003, p. 63). Based on these indicators, women who received high-quality care were 1.3 times more likely to use contraception than those who did not. Receiving routine information at care and follow-up visits is not as effective as personalized counseling. In a study of 350 Mexican women using DMPA, 43.4% of women in the control group who received only routine information on the side effects of DMPA discontinued use (Canto de Cetina, Canto, & Ordonez Luna, 2001). In contrast, the experimental group of women received pretreatment counseling that described DMPA’s mode of action and discussed common side effects including irregular or heavy bleeding and menstrual periods, spotting, and amenorrhea. They were also told that the side effects were not detrimental to their health, and were encouraged to visit their 48 provider if they had any concerns about DMPA’s effect on their health. Only 17% of the experimental group discontinued use of DMPA; the authors concluded that explaining the contraceptive’s effectiveness and mode of action, preparing clients for the potential side effects, and assuring them that the side effects were not detrimental to their health but that they could seek care if they were concerned, were all instrumental in improving the continuation rate of DMPA. A similar study of 811 women in China using DMPA reached comparable conclusions: 11% of women who received structured counseling discontinued the contraceptive, while 42% of women who received only routine counseling discontinued use (Lei et al., 1996). Both the Mexican and Chinese studies utilized audio-visual aids in the structured counseling group; the Mexican study did not describe the audiovisual aids in detail, while the Chinese group’s aid depicted American women discussing their use of DMPA. However, an assessment of 74 articles about contraceptive counseling revealed that the extant literature on contraceptive counseling is unreliable in its determination on the effects of counseling on unintended pregnancy in the United States (Moos, Bartholomew, & Lohr, 2003). The authors of this literature review concluded that, collectively, the body of literature did not provide “definitive guidance about effective counseling strategies” (Moos, Bartholomew, & Lohr, 2003, abstract) and the studies themselves differed widely in methodology, population, and outcomes measured. This is true of the studies examined in this review as well: each study included different indicators of quality of care, and while there was much overlap, there was also a wide variety of populations and methodologies. But as Moos, Bartholomew, and Lohr (2003) 49 point out, the overlap in many of these studies indicates a future direction for research on the contribution of quality of care and counseling to contraceptive continuation and compliance. 50 6.0 CONCLUSION The Guttmacher Institute (2012) estimates that 37 million American women are sexually active and fertile but are not and do not desire pregnancy, while the CDC’s estimate is even higher, at 43 million American women (Jones, Mosher, & Daniels, 2012). While the exact number may be unclear, it is certainly clear that there are millions of American women who are in need of contraception to avoid an unintended pregnancy; it is estimated that more than half of all American women have or will become pregnant without having intended to do so by the age of 45 (Jones & Kavanaugh, 2011). Hormonal contraception is a reliable, long-term, and highly effective way to prevent unintended pregnancies, but it must be taken or used consistently to be highly effective. Contraceptive discontinuation is therefore a major risk factor that may lead to unintended pregnancy. As this paper has shown, contraceptive discontinuation is a widespread phenomenon that has not been widely addressed by researchers or practitioners. This paper’s introduction discussed the advantages of hormonal contraception over barrier methods, natural methods, and sterilization, as well as the public health importance of the topic of contraceptive discontinuation. The following background section discussed the contraceptive usage and needs of American women. The failure rates of the contraceptive methods discussed in this paper were also reviewed, as well 51 as the public impact and current trends, individual and public costs, and outcomes of unintended pregnancies in the United States. This section concluded with a short discussion of the Healthy People 2020 objectives related to reducing unintended pregnancy and increasing use of contraception. In the next section, the methods and criteria used to gather and determine the studies reviewed in this literature synthesis were described; the studies were also described. The results section, organized by method and ordered by popularity of use in the United States, discussed the rates and reasons for discontinuation given by patients in the studies. The results section concluded with a discussion of demographic factors that are also associated with contraceptive discontinuation. This was followed by the discussion section, which included a method-specific discussion of the method-related factors that may be positively or negatively associated with discontinuation. This section concluded with a discussion of client-provider interactions and contraceptive counseling, shown to significantly support and improve contraceptive continuation. Lastly, this paper concludes with this section, a discussion of this paper’s limitations, suggestions and directions for future research, and the public health significance of contraceptive discontinuation. This literature review examined the extant literature on discontinuation of the following hormonal methods of contraception: oral contraceptives, copper intrauterine devices, hormonal intrauterine devices, injectable contraceptives, including depot medroxyprogesterone and combined type, vaginal rings, patches, and implant contraceptives. In addition, the review also examined demographic factors that have been associated with discontinuation, including age, intimate partner violence, 52 reproductive coercion, ethnicity, and socioeconomic status. Based on the review of studies examining discontinuation of hormonal contraceptives, it appears that the most common reason for discontinuation is side effects. While providers usually cannot mitigate side effects of hormonal contraceptives, as they are often unpredictable, other studies have shown that discussing these side effects and other concerns that patients may have about the contraceptive that they are beginning or are currently taking can increase continuation as well as compliance with their regimen. 6.1 LIMITATIONS AND DIRECTIONS FOR FUTURE RESEARCH There are several limitations to this literature review. First, the meta-analysis included only studies that provided quantitative results for discontinuation. Adding qualitative results would improve the quality and depth of a review of reasons why women choose to discontinue their methods of contraception. Second, the populations studied varied widely demographically. Therefore, conclusions are not generalizable to any specific population. Third, many of the studies used only provided rates of discontinuation, and did not provide specific reasons for discontinuation. It would be very instructive for future studies to include reasons for discontinuation, so that these may be addressed in client interventions. Fourth, many of the studies regarding contraceptive counseling only defined counseling in terms of talking to clients around specific objectives, without any theoretical basis. Future studies examining the use of counseling to improve contraceptive compliance or continuation may wish to incorporate behavioral theories of health decision-making, which may increase contraceptive 53 adherence and decrease unwanted pregnancies. Lastly, this review only examined studies published in English. 6.2 PUBLIC HEALTH SIGNIFICANCE Given that increasing the proportion of intended pregnancies and increasing contraceptive use by females (or their partners) at risk of unintended pregnancy at most recent sexual intercourse are Healthy People 2020 objectives, improving maternal health and reducing child mortality are United Nations Millennium Development Goals, and the CDC considers family planning one of the top 10 public health achievements of the 20th century, family planning remains a very significant public health issue. By increasing continuation of contraceptive use, the proportion of unintended pregnancies can be reduced, rates of neonatal/infant/child mortality can be reduced, and women’s health as a whole can be improved. In addition, because contraceptive use puts women in control of their fertility, it also improves their social and economic opportunities. 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