Advancesin Contraception. 1992;8(Suppl1):47-56. ~) 1992KluwerAcademicPublishers.Printedin the Netherlands
Cultural factors in oral contraceptive compliance G. BENAGIANO, MD, and M.G. SHEDLIN, Phi:)
Professor and Director, First Institute of Obstetrics and Gynecology, University "la Sapienza, "Rome, Italy
Giuseppe Benagiano graduated cum laude in Medicine and Surgery from the University of Rome in 1961. In 1964, he was given a Ford Foundation Fellowship for the Hormone Laboratory of the department of women's disease at the Karolinska Sjukhuset in Stockholm. Dr Benagiano was also awarded the title of Libero Docente (corresponding to a PhD) in gynecology and obstetrics in 1967 and in pathophysiology of human reproduction and sterility in 1969. In 1973, the World Health Organization selected him for the position of scientist in the Human Reproduction Unit. From 1975 to 1978, he served as professore incaricato (corresponding to acting professor) at the University of Chieti in Italy. Dr Benagiano was acting professor at the University of Rome from 1978 to 1980. He is currently director of the First Institute of Obstetrics and Gynecology of the University of Rome (renamed University of Rome La Sapienza). Dr Benagiano is a past president of the Italian Society for Clinical Sexology, president elect of the Society for Advancement of Contraception, chairman of the committee for restructuring of the Italian Society for Gynecology and Obstetrics, and a member of the Italian Society for Sterility and Fertility. He is the author of more than 250 scientific publications and the editor of several books, including Endocrine Mechanisms in Fertility Regulation and Progestogens in Therapy. He is the editor of New Trends in Gynecology and Obstetrics and sits on the editorial board of Human Reproduction and Advances in Contraception. Dr Shedlin, a medical anthropologist, is the founder and president of Sociomedical Resource Associates, Westport, Connecticut. She provides technical assistance to research and service programs in the areas o f maternal/child health; reproductive decision making and health care; substance abuse; and H1V/AIDS. Dr Shedlin has many years of experience in the areas of qualitative research, program design and evaluation, research methodology, and in the development of health education materials. She has spent a significant part of her time in Latin America and with Hispanic populations in the United States. She received her PhD from Columbia University.
48
Benagiano and Shedlin
Introduction
The composition of oral contraceptives (OCs) has changed substantially over the 30 years of their clinical use worldwide, indicating that a great deal of attention has been given to their development, in terms of both basic and applied research. In contrast to this, much less attention has been paid to their use-effectiveness, with the understanding that modern OCs are highly effective. Based on pregnancy rates obtained in carefully controlled clinical trials, it has been more or less presumed that, once a woman is "convinced" to use an oral contraceptive, she is in fact fully protected against an unwanted pregnancy. As a consequence of this attitude, little research has been concerned with how to assist women in using OCs more effectively or with identifying ways to promote a better understanding of "compliance." This issue has become even more salient with today's low-dose OCs, which require even stricter compliance than did the earlier higher dose pills. Compliance in general has been defined as "the extent to which a person's behavior (in terms of taking medications, following diets, or executing lifestyle changes) coincides with medical or health advice" [1]. Compliance as it relates to the use of OCs has been equated to "the consistent and correct taking of OCs for the prevention of pregnancy" [2]. Other terms for this phenomenon are "adherence," "concordance," "cooperation" [3], and "conformity" [1]. Problems with compliance of one form or another are usually given as the reason for the difference between theoretical and observed use-effectiveness and failure rates among OC users [4]. These "problems" are said to include missed pills, lost pills, and incorrect use of pill packets. Also, discontinuation of OCs is frequently equated with noncompliance, even when discussed in the light of responses to side effects. The responsibility for noncompliance is often attributed to the pill-packet instruction sheet and/or a willful refusal or misunderstanding on the part of the client. Solutions suggested have been "anticipatory guidance" and clearer instructions regarding the two most common forms of noncompliance: missing one or more pills during a cycle and failing to start a new pill packet on the right day [4]. This approach, however, fails to address some of the major reasons for noncompliance, namely cultural and personal beliefs. Jay et al suggest that noncompliance is a diagnostic issue and state that "a physician's first and most critical task" is to differentiate among reasons for noncompliance [1]. Available evidence suggests that noncompliance is indeed a diagnostic issue. However, it seems necessary to take this concept farther and hold that compliance (and the behaviors, attitudes, knowledge, and motivation implied), rather than just noncompliance, is also a diagnostic issue. It is precisely a consideration of the sociocultural factors that we believe has been too often overlooked. For this reason, it is probable that neither a revision of the packet instructions, as has been recently undertaken by the Food and Drug Administration in the United States, nor more easily understood instructions for the patient, is a sufficient strategy alone for addressing the issue of compliance.
Cultural Factors in Oral Contraceptive Compliance
49
A patient's decision not to accept or not to follow medical advice may be quite reasonable, based on her knowledge, experiences, or beliefs. Furthermore, whether in rural areas, traditional communities of the Third World, or inner-city ghettos of the United States, continual exposure to controversies and contradictions fosters fears and a lack of confidence in both the method of oral contraception and the provider who recommends it. Because of these realities, we wish to recommend that the present concept of "compliance" be questioned. In addition, we submit that the meaning and interpretations of the term itself may indicate part of the problem in different cultural contexts. This paper will therefore attempt to evaluate the role of culture in patients" use and success in using OCs as the basis for assessing compliance.
Meaning of "compliance" As Fletcher points out, compliance suggests an asymmetric relationship between provider and patient [3]. The implication is that the patient will accept provider instructions and will cooperate. If these assumptions determine the provider/patient interaction in the family planning consultation, they may limit proper communication and thus impair the resolution of erroneous expectations and the consequent dilution of fears. The result will be inadequate information that, in turn, undermines the correct use of the method. This is especially true regarding oral contraception, in which self-administration and dally motivation are required. The effects of this type of patient-provider relationship persist despite the fact that in many cultures this dynamic is expected, especially between male physicians and female patients. But, culturally appropriate or not, the role/status of the physician and the expectations inherent in the term "compliance" can serve as barriers to the correct use and continuation of contraceptive methods. As Robertson counseled in his discussion of compliance, "The medical profession must drop the mantle of scientific chauvinism and communicate with every patient in human terms" [5]. What is implied here by "human terms" is an attention to the quality of the interaction, as well as the content and quality of information. Of course, rates of noncompliance are affected not only by the perceived roles and expected behaviors of provider and patient, but also by the characteristics of patients and providers, the type of method or program involved, the criteria for compliance, and many other aspects of the context and quality of the family planuing/health care encounter. One of the problems in understanding compliance is that it is largely measured by means of outcome, i.e., prevention of pregnancy and noncontraceptive health benefits. Except by the analysis of body fluids to determine the presence or absence of actual levels of the medication, providers are usually unable to identify noncompliance until a pregnancy occurs, even though breakthrough bleeding may indicate a problem. Furthermore, it is unreasonable to expect that a woman would return to her physician saying that she became pregnant although she took the pill regularly.
50
Benagiano and Shedlin
While data exist for use-effectiveness and discontinuation [4], the motivations and behaviors that constitute the actual use of contraceptives are less well researched. In some countries, "use" has been researched more fully than in others. Henshaw and Silverman, for example, found that 26% of the national sample of abortion patients they surveyed conceived while they were using oral contraception [6]. In a study by Furstenburg et al, increasingly restrictive measures of use produced a variety of distinct research indicators, and each had its own set of determinants and outcomes [7]. Miller, for example, examined the interaction between users and their method in terms of the importance of cognitive and emotional factors. He found that "their importance lies not in the decision to use or not use a method, but in the influence they exert over how the method is used" [8]. Miller's own data from a sample of 642 women with an unwanted pregnancy showed that 21% of those who had become pregnant while using OCs reported that conception occurred when they were starting to use this method for the first time [9]. Miller concludes, "This finding suggests that during the first few weeks or months of the pill, there is a risk period, during which women are learning how to integrate the oral contraceptive regimen into their particular pattern of life" [8]. Clearly, understanding women's patterns to assist this integrative period is critical. These are only a few of many examples in the literature that illustrate how more research on actual behaviors and their cultural context could contribute to the understanding of compliance and the differences between use-effectiveness and theoretical effectiveness. What exactly do we mean when we refer to cultural factors?
Culture and compliance Culture, a word used to mean many things, is - according to anthropologists "patterns of behavior, thought, and feeling.., characteristic of groups of people" [10]. The attitudes, beliefs, behavioral norms, and even ways in which people communicate and learn are culturally determined. Religion, of course, is often a part of the culture of a population or community and is well recognized as an important factor in influencing the impact of family planning programs as well as individual fertility goals and behaviors. Religion and other cultural factors, however, play a crucial role not only in fertility decision making, but also in the way in which individuals experience and perceive their bodies. These perceptions are culturally patterned since the structure and functioning of the body are a reflection of culturally determined cognitive categories [11]. Inherent in many family planning and women's health programs - especially those designed and developed by industrialized countries but meant for developing countries - is the mistaken assumption that the body, its processes, and modifications to it (such as disease and side effects of contraceptive methods) are universally experienced in the same way. These assumptions have contributed to the underutilization and lessened impact of health care programs in general, and specifically to noncompliance with medical and contraceptive regimens. Worldwide statistics on noncompliance/use-effectiveness and discontinuation of OCs increasingly
Cultural Factors in Oral Contraceptive Compliance
51
emphasize the need to understand patients' perceptions of health and contraceptive needs. While these perceptions are derived primarily from a sense of well-being, they also result from clinical information or, rather, from the information the patient receives from a variety of medical as well as nonmedical sources. Western cultures tend to view the body as a collection of parts, each separate but useful in its own way. In many countries where education and correct information have not reached large sections of the population, interpretations of the body and body processes are based on folk beliefs, These beliefs often contain distorted and fallacious ideas about anatomy and physiology that prevent individuals from developing an accurate comprehension of their bodies. Understanding these beliefs and ideas can be important for the health care giver to provide appropriate and meaningful information and education about contraceptives, their effects on the body, and their correct use. In addition to taking into account the influence of culture on body knowledge and beliefs, an examination of compliance must consider the cultural acceptability of methods. Acceptability is not acceptance, but rather the compatibility of the method with the values, norms, and beliefs of the patient. Acceptability means consonance with a sense of well-being. In 1973, the World Health Organization suggested that methods are assessed by potential adopters in terms of their qualities or attributes, which include gender of user, mechanism of action, mode of administration, route of administration, effectiveness, safety, duration of action, organs implicated, provideror self-administration, requirement of an examination, frequency of use, physical attributes, ease of use, coitus-relatedness, and side effects. The importance and meaning of each attribute varies among individuals and cultures. The ultimate acceptability of each method depends on the potential user's cost/benefit assessment of all the attributes perceived as important. In addition, health, age, parity, lifestyle, and motivation to avoid pregnancy influence how a method and its attributes are assessed [12]. If any of the important attributes of OCs are perceived negatively by the patient, this may directly affect use-effectiveness and compliance. For example, if a patient is concerned that the "medicine" contained in the pill will harm future offspring, or that a pill is not as effective as an injection, or that the effect will be permanent or cause impairment of future fertility, or that the hormones contained in the pill will cause cancer, these fears and beliefs may influence her motivation or commitment to c o r r e c t use.
Side effects have been shown to be the most salient attributes in OC acceptance and continuation [13]. Side effects and how they are perceived, experienced, and interpreted are also important factors in compliance. This, in turn, depends to a large extent on the previously mentioned issue of beliefs and knowledge of reproductive anatomy and physiology. Such knowledge and beliefs may combine correct and erroneous assumptions and may cause a patient to fear alterations in her body, such as changes in bleeding patterns. In other cases, these beliefs may be responsible for a misinterpretation of the mechanism of action of OCs. Both of these possibilities can negatively affect compliance because the individual's concerns and understanding of the method serve as barriers to appropriate action/correct use.
52
Benagiano and Shedlin
An interesting example of how body knowledge can influence compliance is illustrated by Shedlin and Hollerbach [14]. Research on traditional fertility regulation in Central Mexico documented the belief that conception occurs when the "blood" of the man joins with the "blood" of the woman in the "stomach" (or uterus). The pill was believed to weaken the woman's blood so that it could not join with that of the man. Pills were thus "missed" periodically to permit the woman's blood to "get stronger" because, in most traditional cultures, weak blood is believed to cause susceptibility to illness. In this case it was particularly clear that incorrect knowledge and traditional beliefs interfered with women's compliance with their OC regimens. Although instructions for use were understood, those instructions did not take into account the women's interpretation of the effects and mechanism of action of the method. The way side effects and therefore the risk/benefit ratio of OC use are perceived represents an important factor in determining compliance, even in Western countries. This is clearly shown by levels of use. Although Europe is uniting in many ways and the West in general is becoming more uniform, this is not true of oral contraception: Figure 1 shows that use of reliable contraceptive methods varies from almost 90% in Sweden and Denmark to less than 50% in Italy. The differences become even more important when considering OCs. Table 1, which refers to the situation existing in 1985, indicates that OC use by women of childbearing age to whom OCs were available ranged between more than 40% in Austria to only 6% in Italy. These differences, however, do not concern the status of women of fertile age. With the exception of Spain, the percentage of women who are not sexually active, pregnant, postponing pregnancy, and not wanting additional children is about the same in the eight countries considered. Knowledge and experience about oral contraception are lowest in countries where OC use is also lowest. However, no simple relationship can be found when trying to analyze reasons for the different behavior among European women. All methods 100 -~
~_,~
.
.
.
.
~R
80
OLO
6o ~
0
~
40
2o o
0
ItaLy
France
Great Britain
Spain
Fed. Rep. Germany
Austria
Figure I Percentage of women using reliable methods vs all contraceptive methods
Sweden
Denmark
Cultural Factors in Oral Contraceptive Compliance
Table 1 Use of contraceptive methods (%) by e ~ d
Method None Rhythm Withdrawal Barrier IUD OCs Sterilization Total
53
women aged 15-44
France
Great Britain
Ireland
30 12 14 23 15 6 0
24 6 6 9 19 31 5
10 1 3 17 8 38 23
26 7 9 23 13 19 3
19 14 10 7 10 33 7
18 7 5 16 7 42 5
5 1 5 27 19 37 6
8 0 3 25 14 36 14
100
100
100
100
100
100
100
I00
Italy
Germany (FRG) Austria
Sweden
Denmark
Contraception was legalized in Italy in 1968 and in France in 1974, although OCs have been available in France since 1967. Experience with oral contraception has, therefore, been very similar in these two countries. Yet OC use today is below 9% in Italy and above 30% in France. Both countries are of Latin origin, are Catholic, and generally share the same culture. Therefore, it is not immediately evident why their citizens behave in such different ways. The only logical way to explain differences in contraceptive use, continuation, and compliance among women of Western countries is to accept the existence of a different perception of the risk/benefits ratio of OC use and of the possibility of achieving contraception successfully with other methods. In other words, education and the attitudes of the media and of physicians will cause women to look at OCs differently. Differences in the perception of the risk/benefits ratio can be observed in several areas. For instance, the way a woman experiences her own body may influence her perception of the importance of the benefits or of the risks. A woman will use her ethnically patterned concepts of bodily functions to choose or reject OC use. Furthermore, she will use her culturally determined perception of its mode of action to judge whether oral contraception is physiologic or unnatural, that is, whether it interferes with vital bodily functions. Culturally determined perceptions of the attributes of OCs can influence compliance. For example, the likelihood of menstrual irregularities can be a major concern. Bleeding irregularities are poorly tolerated in Italy and in many other cultures; however, they do not seem to influence the continuation of OC use among Thai women. In the United Kingdom, two of five OC users will delay starting a new pill pack because of amenorrhea, with obvious consequences regarding compliance. Another area that can affect compliance is the perception of the importance of visible side effects of OC use. Some women cannot tolerate weight gain; others fear the possibility of accumulating cellulite or retaining water (bloating). A third area concerns fear of cancer. If women do not grasp the importance of the established protection from certain cancers offered by OCs versus the possible
54
Benagiano and Shedlin
increased risk of others, they may fail to comply with the regimen or discontinue OC use simply because of anxiety due to a fear of the unknown.
Patient ability to comply
An assessment of compliance must begin with a patient's understanding of the provider's recommendations. However, understanding and acceptability, while crucial to correct use and continuation, are not sufficient. Lifestyle issues, partner influence and behavior, cost, storage, and accessibility are all factors that may influence a woman's ability to use oral contraception correctly. Addiction - even the occasional use of illicit drugs - and abuse of alcohol are other factors that may interfere with a woman's ability to comply with an OC regimen. Of course, partial compliance may have the same results as noncompliance.
Enhancing
compliance
Various steps can be undertaken by pharmaceutical companies, health care programs, and providers to enhance correct use of OCs. The following is a llst of some steps that involve a consideration of cultural factors: Ensuring cooperation, understanding, and communication through satisfaction with the patient-provider relationship and other aspects of the medical/family planning encounter -
Determination of the patient's level of understanding of contraception and the nature of OCs
-
Assessment of those characteristics of the patient that can act as barriers to her ability and desire to use OCs correctly
-
Assessment of the situational factors that might influence desire and ability to use OCs correctly Encouragement of questions in the initial consultation and in follow-up visits when new issues and concerns may emerge. A lack of questions does not necessarily indicate satisfaction or compliance, especially in traditional cultures.
Referral to, or creation of, a culturally appropriate and accessible mechanism for patient support. This is especially important for counseling and providing information on side effects, their management, and what to do when pills are missed.
Cultural Factors in Oral Contraceptive Compliance
55
Emphasis on method effectiveness and the attributes of OCs that are culturally acceptable and an attempt to address the attributes of OCs that may have negative cultural interpretations Information about noncontraceptive health benefits and their relation to the individual patient Direction of attention to media issues or local myths that may undermine use-effectiveness i'
Selection of packaging appropriate to client needs, including clear labeling and easily understood instruction Provision of a backup method (such as condoms) along with pill packets, with instructions on how and when to use that method when pills are missed or stopped
Conclusions
Clearly, these recommendations place greater responsibilities on the provider. Especially difficult in some cases may be the responsibility for recognizing and understanding the cultural factors that may affect a patient's motivation and ability to comply. In multicultural settings, the challenge obviously includes a reliance on informed and culturally knowledgeable staff. Providers and the programs in which they collaborate need to go beyond such catchwords as "cultural awareness" and "cultural sensitivity." There is a real need across countries, cultures, and programs to consider such basic issues as how women perceive their bodies, alterations in body function, and the meanings of specific behaviors and method attributes. Only when cultural factors are considered will such improvements as pill packaging, instruction sheets, and provider counseling have their fullest impact. The consequences, as Potter and Williams-Deane, Wildermeersch and others have pointed out, would be far-reachlng, since "if we could reduce the failure rate of the pill by even 1% by improving pill taking, at least 630,000 fewer women would have accidental pregnancies each year" [2].
References 1. 2. 3. 4. 5.
Jay S, Litt I, Durant R. Compliance with therapeutic regimens. J Adolesc Health Care. 1984;5:124-136. Potter L, Williams-Deane M. The importance of oral contraceptive compliance. IPPF Med Bull. 1990;24:2-3. Fletcher RH. Patient compliance with therapeutic advice: a modern view. Mt Sinai J Med. 1989;56:453-458. The Contraception Report, OC compliance and contraceptive failure. Morris Plains, NJ: Emron; 1990:1(4):3. Robertson WH. The problem of patient compliance. Am J Obstet Gynecol. 1985;152:948-952.
56
Benagiano and Shedlin
6.
Henshaw SK, Silverman J. The characteristics and prior contraceptive use of U.S. abortion patients. Fam Plann Perspect. 1988;20:158-168. Furstenberg FF Jr, Shea J, Allison P, Herceg-Baron R, Webb D. Contraceptive continuation among adolescents attending family planning clinics. Fam Plann Perspect. 1983;15:211-217. Miller WB. Why some women fail to use their contraceptive method: a psychological investigation. Faro Plann Perspect. 1986;18:27-32. Miller WB. Psychological antecedents to conception among abortion seekers. W J Med. 1975;122: 12-19. Harris M. Culture, Man and Society. Crowell, 1971. Shedlin MG. Assessment of body concepts and beliefs regarding reproductive physiology. Stud Fam Plann. 1979;10:393-397. World Health Organization, Task Force on Acceptability of Fertility Regulating Methods, 1973: (DOC. ATF-G:5) I,3. Balassone ML, Risk of contraceptive discontinuation among adolescents. J Adolesc Health Care. 1989; 10:527-533. Shedlin MG, Hollerbach PE. Modern and traditional fertility regulation in a Mexican community:. The process of decision making. Stud Fam Plann. 1981:278-296.
7. 8. 9. 10. 11. 12. 13. 14.
Cultural factors in oral contraceptive compliance G. BENAGIANO, MD, and M.G. SHEDLIN, Phi:)
Professor and Director, First Institute of Obstetrics and Gynecology, University "la Sapienza, "Rome, Italy
Giuseppe Benagiano graduated cum laude in Medicine and Surgery from the University of Rome in 1961. In 1964, he was given a Ford Foundation Fellowship for the Hormone Laboratory of the department of women's disease at the Karolinska Sjukhuset in Stockholm. Dr Benagiano was also awarded the title of Libero Docente (corresponding to a PhD) in gynecology and obstetrics in 1967 and in pathophysiology of human reproduction and sterility in 1969. In 1973, the World Health Organization selected him for the position of scientist in the Human Reproduction Unit. From 1975 to 1978, he served as professore incaricato (corresponding to acting professor) at the University of Chieti in Italy. Dr Benagiano was acting professor at the University of Rome from 1978 to 1980. He is currently director of the First Institute of Obstetrics and Gynecology of the University of Rome (renamed University of Rome La Sapienza). Dr Benagiano is a past president of the Italian Society for Clinical Sexology, president elect of the Society for Advancement of Contraception, chairman of the committee for restructuring of the Italian Society for Gynecology and Obstetrics, and a member of the Italian Society for Sterility and Fertility. He is the author of more than 250 scientific publications and the editor of several books, including Endocrine Mechanisms in Fertility Regulation and Progestogens in Therapy. He is the editor of New Trends in Gynecology and Obstetrics and sits on the editorial board of Human Reproduction and Advances in Contraception. Dr Shedlin, a medical anthropologist, is the founder and president of Sociomedical Resource Associates, Westport, Connecticut. She provides technical assistance to research and service programs in the areas o f maternal/child health; reproductive decision making and health care; substance abuse; and H1V/AIDS. Dr Shedlin has many years of experience in the areas of qualitative research, program design and evaluation, research methodology, and in the development of health education materials. She has spent a significant part of her time in Latin America and with Hispanic populations in the United States. She received her PhD from Columbia University.
48
Benagiano and Shedlin
Introduction
The composition of oral contraceptives (OCs) has changed substantially over the 30 years of their clinical use worldwide, indicating that a great deal of attention has been given to their development, in terms of both basic and applied research. In contrast to this, much less attention has been paid to their use-effectiveness, with the understanding that modern OCs are highly effective. Based on pregnancy rates obtained in carefully controlled clinical trials, it has been more or less presumed that, once a woman is "convinced" to use an oral contraceptive, she is in fact fully protected against an unwanted pregnancy. As a consequence of this attitude, little research has been concerned with how to assist women in using OCs more effectively or with identifying ways to promote a better understanding of "compliance." This issue has become even more salient with today's low-dose OCs, which require even stricter compliance than did the earlier higher dose pills. Compliance in general has been defined as "the extent to which a person's behavior (in terms of taking medications, following diets, or executing lifestyle changes) coincides with medical or health advice" [1]. Compliance as it relates to the use of OCs has been equated to "the consistent and correct taking of OCs for the prevention of pregnancy" [2]. Other terms for this phenomenon are "adherence," "concordance," "cooperation" [3], and "conformity" [1]. Problems with compliance of one form or another are usually given as the reason for the difference between theoretical and observed use-effectiveness and failure rates among OC users [4]. These "problems" are said to include missed pills, lost pills, and incorrect use of pill packets. Also, discontinuation of OCs is frequently equated with noncompliance, even when discussed in the light of responses to side effects. The responsibility for noncompliance is often attributed to the pill-packet instruction sheet and/or a willful refusal or misunderstanding on the part of the client. Solutions suggested have been "anticipatory guidance" and clearer instructions regarding the two most common forms of noncompliance: missing one or more pills during a cycle and failing to start a new pill packet on the right day [4]. This approach, however, fails to address some of the major reasons for noncompliance, namely cultural and personal beliefs. Jay et al suggest that noncompliance is a diagnostic issue and state that "a physician's first and most critical task" is to differentiate among reasons for noncompliance [1]. Available evidence suggests that noncompliance is indeed a diagnostic issue. However, it seems necessary to take this concept farther and hold that compliance (and the behaviors, attitudes, knowledge, and motivation implied), rather than just noncompliance, is also a diagnostic issue. It is precisely a consideration of the sociocultural factors that we believe has been too often overlooked. For this reason, it is probable that neither a revision of the packet instructions, as has been recently undertaken by the Food and Drug Administration in the United States, nor more easily understood instructions for the patient, is a sufficient strategy alone for addressing the issue of compliance.
Cultural Factors in Oral Contraceptive Compliance
49
A patient's decision not to accept or not to follow medical advice may be quite reasonable, based on her knowledge, experiences, or beliefs. Furthermore, whether in rural areas, traditional communities of the Third World, or inner-city ghettos of the United States, continual exposure to controversies and contradictions fosters fears and a lack of confidence in both the method of oral contraception and the provider who recommends it. Because of these realities, we wish to recommend that the present concept of "compliance" be questioned. In addition, we submit that the meaning and interpretations of the term itself may indicate part of the problem in different cultural contexts. This paper will therefore attempt to evaluate the role of culture in patients" use and success in using OCs as the basis for assessing compliance.
Meaning of "compliance" As Fletcher points out, compliance suggests an asymmetric relationship between provider and patient [3]. The implication is that the patient will accept provider instructions and will cooperate. If these assumptions determine the provider/patient interaction in the family planning consultation, they may limit proper communication and thus impair the resolution of erroneous expectations and the consequent dilution of fears. The result will be inadequate information that, in turn, undermines the correct use of the method. This is especially true regarding oral contraception, in which self-administration and dally motivation are required. The effects of this type of patient-provider relationship persist despite the fact that in many cultures this dynamic is expected, especially between male physicians and female patients. But, culturally appropriate or not, the role/status of the physician and the expectations inherent in the term "compliance" can serve as barriers to the correct use and continuation of contraceptive methods. As Robertson counseled in his discussion of compliance, "The medical profession must drop the mantle of scientific chauvinism and communicate with every patient in human terms" [5]. What is implied here by "human terms" is an attention to the quality of the interaction, as well as the content and quality of information. Of course, rates of noncompliance are affected not only by the perceived roles and expected behaviors of provider and patient, but also by the characteristics of patients and providers, the type of method or program involved, the criteria for compliance, and many other aspects of the context and quality of the family planuing/health care encounter. One of the problems in understanding compliance is that it is largely measured by means of outcome, i.e., prevention of pregnancy and noncontraceptive health benefits. Except by the analysis of body fluids to determine the presence or absence of actual levels of the medication, providers are usually unable to identify noncompliance until a pregnancy occurs, even though breakthrough bleeding may indicate a problem. Furthermore, it is unreasonable to expect that a woman would return to her physician saying that she became pregnant although she took the pill regularly.
50
Benagiano and Shedlin
While data exist for use-effectiveness and discontinuation [4], the motivations and behaviors that constitute the actual use of contraceptives are less well researched. In some countries, "use" has been researched more fully than in others. Henshaw and Silverman, for example, found that 26% of the national sample of abortion patients they surveyed conceived while they were using oral contraception [6]. In a study by Furstenburg et al, increasingly restrictive measures of use produced a variety of distinct research indicators, and each had its own set of determinants and outcomes [7]. Miller, for example, examined the interaction between users and their method in terms of the importance of cognitive and emotional factors. He found that "their importance lies not in the decision to use or not use a method, but in the influence they exert over how the method is used" [8]. Miller's own data from a sample of 642 women with an unwanted pregnancy showed that 21% of those who had become pregnant while using OCs reported that conception occurred when they were starting to use this method for the first time [9]. Miller concludes, "This finding suggests that during the first few weeks or months of the pill, there is a risk period, during which women are learning how to integrate the oral contraceptive regimen into their particular pattern of life" [8]. Clearly, understanding women's patterns to assist this integrative period is critical. These are only a few of many examples in the literature that illustrate how more research on actual behaviors and their cultural context could contribute to the understanding of compliance and the differences between use-effectiveness and theoretical effectiveness. What exactly do we mean when we refer to cultural factors?
Culture and compliance Culture, a word used to mean many things, is - according to anthropologists "patterns of behavior, thought, and feeling.., characteristic of groups of people" [10]. The attitudes, beliefs, behavioral norms, and even ways in which people communicate and learn are culturally determined. Religion, of course, is often a part of the culture of a population or community and is well recognized as an important factor in influencing the impact of family planning programs as well as individual fertility goals and behaviors. Religion and other cultural factors, however, play a crucial role not only in fertility decision making, but also in the way in which individuals experience and perceive their bodies. These perceptions are culturally patterned since the structure and functioning of the body are a reflection of culturally determined cognitive categories [11]. Inherent in many family planning and women's health programs - especially those designed and developed by industrialized countries but meant for developing countries - is the mistaken assumption that the body, its processes, and modifications to it (such as disease and side effects of contraceptive methods) are universally experienced in the same way. These assumptions have contributed to the underutilization and lessened impact of health care programs in general, and specifically to noncompliance with medical and contraceptive regimens. Worldwide statistics on noncompliance/use-effectiveness and discontinuation of OCs increasingly
Cultural Factors in Oral Contraceptive Compliance
51
emphasize the need to understand patients' perceptions of health and contraceptive needs. While these perceptions are derived primarily from a sense of well-being, they also result from clinical information or, rather, from the information the patient receives from a variety of medical as well as nonmedical sources. Western cultures tend to view the body as a collection of parts, each separate but useful in its own way. In many countries where education and correct information have not reached large sections of the population, interpretations of the body and body processes are based on folk beliefs, These beliefs often contain distorted and fallacious ideas about anatomy and physiology that prevent individuals from developing an accurate comprehension of their bodies. Understanding these beliefs and ideas can be important for the health care giver to provide appropriate and meaningful information and education about contraceptives, their effects on the body, and their correct use. In addition to taking into account the influence of culture on body knowledge and beliefs, an examination of compliance must consider the cultural acceptability of methods. Acceptability is not acceptance, but rather the compatibility of the method with the values, norms, and beliefs of the patient. Acceptability means consonance with a sense of well-being. In 1973, the World Health Organization suggested that methods are assessed by potential adopters in terms of their qualities or attributes, which include gender of user, mechanism of action, mode of administration, route of administration, effectiveness, safety, duration of action, organs implicated, provideror self-administration, requirement of an examination, frequency of use, physical attributes, ease of use, coitus-relatedness, and side effects. The importance and meaning of each attribute varies among individuals and cultures. The ultimate acceptability of each method depends on the potential user's cost/benefit assessment of all the attributes perceived as important. In addition, health, age, parity, lifestyle, and motivation to avoid pregnancy influence how a method and its attributes are assessed [12]. If any of the important attributes of OCs are perceived negatively by the patient, this may directly affect use-effectiveness and compliance. For example, if a patient is concerned that the "medicine" contained in the pill will harm future offspring, or that a pill is not as effective as an injection, or that the effect will be permanent or cause impairment of future fertility, or that the hormones contained in the pill will cause cancer, these fears and beliefs may influence her motivation or commitment to c o r r e c t use.
Side effects have been shown to be the most salient attributes in OC acceptance and continuation [13]. Side effects and how they are perceived, experienced, and interpreted are also important factors in compliance. This, in turn, depends to a large extent on the previously mentioned issue of beliefs and knowledge of reproductive anatomy and physiology. Such knowledge and beliefs may combine correct and erroneous assumptions and may cause a patient to fear alterations in her body, such as changes in bleeding patterns. In other cases, these beliefs may be responsible for a misinterpretation of the mechanism of action of OCs. Both of these possibilities can negatively affect compliance because the individual's concerns and understanding of the method serve as barriers to appropriate action/correct use.
52
Benagiano and Shedlin
An interesting example of how body knowledge can influence compliance is illustrated by Shedlin and Hollerbach [14]. Research on traditional fertility regulation in Central Mexico documented the belief that conception occurs when the "blood" of the man joins with the "blood" of the woman in the "stomach" (or uterus). The pill was believed to weaken the woman's blood so that it could not join with that of the man. Pills were thus "missed" periodically to permit the woman's blood to "get stronger" because, in most traditional cultures, weak blood is believed to cause susceptibility to illness. In this case it was particularly clear that incorrect knowledge and traditional beliefs interfered with women's compliance with their OC regimens. Although instructions for use were understood, those instructions did not take into account the women's interpretation of the effects and mechanism of action of the method. The way side effects and therefore the risk/benefit ratio of OC use are perceived represents an important factor in determining compliance, even in Western countries. This is clearly shown by levels of use. Although Europe is uniting in many ways and the West in general is becoming more uniform, this is not true of oral contraception: Figure 1 shows that use of reliable contraceptive methods varies from almost 90% in Sweden and Denmark to less than 50% in Italy. The differences become even more important when considering OCs. Table 1, which refers to the situation existing in 1985, indicates that OC use by women of childbearing age to whom OCs were available ranged between more than 40% in Austria to only 6% in Italy. These differences, however, do not concern the status of women of fertile age. With the exception of Spain, the percentage of women who are not sexually active, pregnant, postponing pregnancy, and not wanting additional children is about the same in the eight countries considered. Knowledge and experience about oral contraception are lowest in countries where OC use is also lowest. However, no simple relationship can be found when trying to analyze reasons for the different behavior among European women. All methods 100 -~
~_,~
.
.
.
.
~R
80
OLO
6o ~
0
~
40
2o o
0
ItaLy
France
Great Britain
Spain
Fed. Rep. Germany
Austria
Figure I Percentage of women using reliable methods vs all contraceptive methods
Sweden
Denmark
Cultural Factors in Oral Contraceptive Compliance
Table 1 Use of contraceptive methods (%) by e ~ d
Method None Rhythm Withdrawal Barrier IUD OCs Sterilization Total
53
women aged 15-44
France
Great Britain
Ireland
30 12 14 23 15 6 0
24 6 6 9 19 31 5
10 1 3 17 8 38 23
26 7 9 23 13 19 3
19 14 10 7 10 33 7
18 7 5 16 7 42 5
5 1 5 27 19 37 6
8 0 3 25 14 36 14
100
100
100
100
100
100
100
I00
Italy
Germany (FRG) Austria
Sweden
Denmark
Contraception was legalized in Italy in 1968 and in France in 1974, although OCs have been available in France since 1967. Experience with oral contraception has, therefore, been very similar in these two countries. Yet OC use today is below 9% in Italy and above 30% in France. Both countries are of Latin origin, are Catholic, and generally share the same culture. Therefore, it is not immediately evident why their citizens behave in such different ways. The only logical way to explain differences in contraceptive use, continuation, and compliance among women of Western countries is to accept the existence of a different perception of the risk/benefits ratio of OC use and of the possibility of achieving contraception successfully with other methods. In other words, education and the attitudes of the media and of physicians will cause women to look at OCs differently. Differences in the perception of the risk/benefits ratio can be observed in several areas. For instance, the way a woman experiences her own body may influence her perception of the importance of the benefits or of the risks. A woman will use her ethnically patterned concepts of bodily functions to choose or reject OC use. Furthermore, she will use her culturally determined perception of its mode of action to judge whether oral contraception is physiologic or unnatural, that is, whether it interferes with vital bodily functions. Culturally determined perceptions of the attributes of OCs can influence compliance. For example, the likelihood of menstrual irregularities can be a major concern. Bleeding irregularities are poorly tolerated in Italy and in many other cultures; however, they do not seem to influence the continuation of OC use among Thai women. In the United Kingdom, two of five OC users will delay starting a new pill pack because of amenorrhea, with obvious consequences regarding compliance. Another area that can affect compliance is the perception of the importance of visible side effects of OC use. Some women cannot tolerate weight gain; others fear the possibility of accumulating cellulite or retaining water (bloating). A third area concerns fear of cancer. If women do not grasp the importance of the established protection from certain cancers offered by OCs versus the possible
54
Benagiano and Shedlin
increased risk of others, they may fail to comply with the regimen or discontinue OC use simply because of anxiety due to a fear of the unknown.
Patient ability to comply
An assessment of compliance must begin with a patient's understanding of the provider's recommendations. However, understanding and acceptability, while crucial to correct use and continuation, are not sufficient. Lifestyle issues, partner influence and behavior, cost, storage, and accessibility are all factors that may influence a woman's ability to use oral contraception correctly. Addiction - even the occasional use of illicit drugs - and abuse of alcohol are other factors that may interfere with a woman's ability to comply with an OC regimen. Of course, partial compliance may have the same results as noncompliance.
Enhancing
compliance
Various steps can be undertaken by pharmaceutical companies, health care programs, and providers to enhance correct use of OCs. The following is a llst of some steps that involve a consideration of cultural factors: Ensuring cooperation, understanding, and communication through satisfaction with the patient-provider relationship and other aspects of the medical/family planning encounter -
Determination of the patient's level of understanding of contraception and the nature of OCs
-
Assessment of those characteristics of the patient that can act as barriers to her ability and desire to use OCs correctly
-
Assessment of the situational factors that might influence desire and ability to use OCs correctly Encouragement of questions in the initial consultation and in follow-up visits when new issues and concerns may emerge. A lack of questions does not necessarily indicate satisfaction or compliance, especially in traditional cultures.
Referral to, or creation of, a culturally appropriate and accessible mechanism for patient support. This is especially important for counseling and providing information on side effects, their management, and what to do when pills are missed.
Cultural Factors in Oral Contraceptive Compliance
55
Emphasis on method effectiveness and the attributes of OCs that are culturally acceptable and an attempt to address the attributes of OCs that may have negative cultural interpretations Information about noncontraceptive health benefits and their relation to the individual patient Direction of attention to media issues or local myths that may undermine use-effectiveness i'
Selection of packaging appropriate to client needs, including clear labeling and easily understood instruction Provision of a backup method (such as condoms) along with pill packets, with instructions on how and when to use that method when pills are missed or stopped
Conclusions
Clearly, these recommendations place greater responsibilities on the provider. Especially difficult in some cases may be the responsibility for recognizing and understanding the cultural factors that may affect a patient's motivation and ability to comply. In multicultural settings, the challenge obviously includes a reliance on informed and culturally knowledgeable staff. Providers and the programs in which they collaborate need to go beyond such catchwords as "cultural awareness" and "cultural sensitivity." There is a real need across countries, cultures, and programs to consider such basic issues as how women perceive their bodies, alterations in body function, and the meanings of specific behaviors and method attributes. Only when cultural factors are considered will such improvements as pill packaging, instruction sheets, and provider counseling have their fullest impact. The consequences, as Potter and Williams-Deane, Wildermeersch and others have pointed out, would be far-reachlng, since "if we could reduce the failure rate of the pill by even 1% by improving pill taking, at least 630,000 fewer women would have accidental pregnancies each year" [2].
References 1. 2. 3. 4. 5.
Jay S, Litt I, Durant R. Compliance with therapeutic regimens. J Adolesc Health Care. 1984;5:124-136. Potter L, Williams-Deane M. The importance of oral contraceptive compliance. IPPF Med Bull. 1990;24:2-3. Fletcher RH. Patient compliance with therapeutic advice: a modern view. Mt Sinai J Med. 1989;56:453-458. The Contraception Report, OC compliance and contraceptive failure. Morris Plains, NJ: Emron; 1990:1(4):3. Robertson WH. The problem of patient compliance. Am J Obstet Gynecol. 1985;152:948-952.
56
Benagiano and Shedlin
6.
Henshaw SK, Silverman J. The characteristics and prior contraceptive use of U.S. abortion patients. Fam Plann Perspect. 1988;20:158-168. Furstenberg FF Jr, Shea J, Allison P, Herceg-Baron R, Webb D. Contraceptive continuation among adolescents attending family planning clinics. Fam Plann Perspect. 1983;15:211-217. Miller WB. Why some women fail to use their contraceptive method: a psychological investigation. Faro Plann Perspect. 1986;18:27-32. Miller WB. Psychological antecedents to conception among abortion seekers. W J Med. 1975;122: 12-19. Harris M. Culture, Man and Society. Crowell, 1971. Shedlin MG. Assessment of body concepts and beliefs regarding reproductive physiology. Stud Fam Plann. 1979;10:393-397. World Health Organization, Task Force on Acceptability of Fertility Regulating Methods, 1973: (DOC. ATF-G:5) I,3. Balassone ML, Risk of contraceptive discontinuation among adolescents. J Adolesc Health Care. 1989; 10:527-533. Shedlin MG, Hollerbach PE. Modern and traditional fertility regulation in a Mexican community:. The process of decision making. Stud Fam Plann. 1981:278-296.
7. 8. 9. 10. 11. 12. 13. 14.
