Women's recollections regarding the initiation of oral contraceptives and their perceived importance upon compliance a descriptive study

Oral contraceptives (OCs) represent one of the most popular and efficacious reversible forms of birth control available to women in the United States. However, there continues to be a high rate of discontinuation due to experiences of side effects. Most women (80%) should be able to tolerate at least one of the available OC preparations without side effects of any type. Previous studies conducted on OC discontinuation have suggested that an increase in patient education regarding side effects improves compliance. The purpose of this study was to describe women's recollections of their experience with OCs and their perceptions of the significance of education provided to them as it related to side effect severity perception and compliance. A sample of 30 women who had initiated OCs within the past 2 years at Planned Parenthood Association of Utah, located in Salt Lake City, was obtained by convenience sampling. Quantitative data were gathered using a questionnaire developed for this study. Data were analyzed using frequency distributions, t tests, and Pearson's r. Results included that side effect severity was perceived as higher if the side effect was unexpected. In addition, the unexpected side effects led to the most OC discontinuations in the sample. There was an overall low frequency of side effects discussed with the provider. Neither discussion of the side effect with the provider nor presence of a 3-month follow-up were significantly related to side effect severity perception. The educational points listed on the protocol had an extremely high recall rate and were ranked by the subjects to be mostly important to them. Implications from the data suggest that expanding the side effect patient education at initiation and follow-up to include specific side effect anticipatory guidance may reduce the unexpectedness of the side effect and thereby limit the number of discontinuations. Information gained from this study can be used to plan future research surrounding OC management.

WOMEN'S RECOLLECTIONS REGARDING THE INITIATION OF ORAL CONTRACEPTIVES AND THEIR PERCEIVED IMPORTANCE UPON COMPLIANCE: A DESCRIPTIVE STUDY by Cind y Butters A thesis submitted to the faculty of The University of Utah in partial fulfillment of the requirements for the degree of Master of Science College of Nursing The University of Utah June 1997 Copyright ~ Cindy Butters 1997 All Rights Reserved THE UNIVERSITY OF UTAH GRADUATE SCHOOL SUPERVISORY COMMITTEE APPROVAL of a thesis submitted by Cindy Butters This thesis has been read by each member of the following supervisory committee and by mc:\l0rity vote has been found to be satisfactory. Chair: Lillian M. Nail Lorrie D. Larsen Lisa Nichols THE UNIVERSITY OF UTAH GRADUATE SCHOOL FINAL READING APPROVAL To the Graduate Council of the University of Utah: I have read the thesis of Cindy Butters in its final form and have found that (1) its format, citations, and bibliographic style are consistent and acceptable; (2) its illustrative materials including figures, tables, and charts are in place; and (3) the final manuscript is satisfactory to the supervisory committee and is ready for submission to The Graduate School. Date <f Lillian M. Nail Chair, Supervisory Committee Approved for the Major Department ~i~ Linda K. Amos Chair/Dean Approved for the Graduate Council /') , . (',,)., X/\' Lu, A1~; J­Ann W. Hart Dean of The Graduate School ABSTRACT Oral contraceptives (OCs) represent one of the most popular and efficacious reversible forms of birth control available to women in the United States. However, there continues to be a high rate of discontinuation due to experiences of side effects. Most women (80 %) should be able to tolerate at least one of the available OC preparations without side effects of any type. Previous studies conducted on OC discontinuation have suggested that an increase in patient education regarding side effects improves compliance. The purpose of this study was to describe women's recollections of their experience with OCs and their perceptions of the significance of education provided to them as it related to side effect severity perception and compliance. A sample of 30 women who had initiated OCs within the past 2 years at Planned Parenthood Association of Utah, located in Salt Lake City, was obtained by convenience sampling. Quantitative data were gathered using a questionnaire developed for this study. Data were analyzed using frequency distributions, 1 tests, and Pearson's r. Results included that side effect severity was perceived as higher if the side effect was unexpected. In addition, the unexpected side effects led to the most OC discontinuations in the sample. There was an overall low frequency of side effects discussed with the provider. Neither discussion of the side effect with the provider nor presence of a 3-month follow-up were significantly related to side effect severity perception. The educational points listed on the protocol had an extremely high recall rate and were ranked by the subjects to be mostly important to them. Implications from the data suggest that expanding the side effect patient education at initiation and follow-up to include specific side effect anticipatory guidance may reduce the unexpectedness of the side effect and thereby limit the number of discontinuations. Information gained from this study can be used to plan future research surrounding OC management. v TABLE OF CONTENTS Page ABSTRACT ......................................... IV LIST OF TABLES ..................................... ix LIST OF FIGURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x ACKNOWLEDGMENTS ................................. Xl Chapter 1. INTRODUCTION................................. 1 Statement of the Problem ............................. 2 Economic Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Purpose of the Thesis ............................... 6 Research Questions of the Thesis. . . . . . . . . . . . . . . . . . . . . . . . . 7 II. REVIEW OF THE LITERATURE ....................... 8 History of Oral Contraceptives . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Composition of Today's Oral Contraceptives ............. 9 Biological Activity of Oral Contraceptives. . . . . . . . . . . . .. 10 Adverse Effects of Oral Contraceptives ............... 11 Research Studies ................................. 12 Theoretical Framework ............................. 14 III. METHODOLOGy................................ 17 Research Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 1 7 Setting and Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 17 Instruments and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . .. 18 Data Analysis ................................... 20 Chapter Page IV. RESULTS ..................................... 21 Sample ....................................... 21 Characteristics of the Sample ..................... 22 Research Question One ............................. 22 Research Question Two ............................. 29 Research Question Three ............................ 32 Research Question Four . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 35 Research Question Five ............................. 38 Research Question Six . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 41 V. DISCUSSION................................... 45 Design ....................................... 46 Usual Care Pattern ................................ 47 Side Effects .................................... 49 Education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 50 Possible Explanations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 52 Implications for Nursing . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 57 Clinical Practice ............................. 57 Education ................................. 58 Future Research ............................. 59 Summary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 60 Appendices A. RELATION OF COMMON SIDE EFFECTS TO HORMONE CONTENT ..................................... 62 B. PLANNED PARENTHOOD ORAL CONTRACEPTIVE INITIATION EDUCATION PROTOCOL ........................... 65 C. CRITERIA OUTLINE .............................. 69 D. COVER LETTER FOR PARTICIPATION IN AN INVESTIGATIONAL STUDY. . . . . . . . . . . . . . . . . . . . . . . .. 71 E. QUESTIONNAIRE................................ 73 Vll Appendix Page F. PLANNED PARENTHOOD FEDERATION ASSOCIATION BROCHURE ON ORAL CONTRACEPTIVES . . . . . . . . . . . . . .. 77 REFERENCES ....................................... 80 viii LIST OF TABLES Table Page 1. Demographic Data (N = 30) . . . . . . . . . . . . . . . . . . . . . . . . .. 23 2. Side Effect Incidence and Mean Severity Scores .............. 28 3. Frequencies of Side Effects Expected or Unexpected. . . . . . . . . . .. 30 4. 5. I-Test Results for Relationship Between Total Side Effect Severity Score and Expectedness Versus Unexpectedness of That Side Effect Frequencies of Educational Points Remembered and Not Remenlbered 6. I-Test Results Comparing Educational Points Remembered and Not 31 33 Remembered To Length of Time Took Oral Contraceptives ....... 34 7. Frequencies of Side Effects Women Remember Discussing With Their Provider and Not Discussing .......................... 36 8. I-Test Results of Discussing Side Effect With Provider or Not and Length of Time on Oral Contraceptives. . . . . . . . . . . . . . . . . . .. 37 9 . I-Test Results of Discussion of Side Effect With Side Effect Severity Score . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 40 10. Frequency of Side Effects That Caused Discontinuation . . . . . . . . .. 42 11. Difference Between Oral Contraceptive Continuers and Discontinuers 43 12. Mean Importance Score of Educational Points. . . . . . . . . . . . . . .. 44 LIST OF FIGURES Figure Page 1. Time since subjects began taking oral contraceptives (N = 30) ..... 24 2. Time subjects had taken oral contraceptives continuously (N = 30) 25 3. Time subjects had stopped taking oral contraceptives prior to completing questionnaire (n = 10) . . . . . . . . . . . . . . . . . . . . . .. 26 4. Pearson's r scatterplot graph: Relationship of total educational importance score and total side effect severity score . . . . . . . . . . .. 39 ACKNOWLEDGMENTS Thank you to all the committee members who gave such incredible insight and support, including Lorrie D. Larsen, Lisa Nichols, and an extraordinary chair, Lillian M. Nail. You have all been wonderful mentors in my learning process. Thank you also to my family, especially Rob, C.J., and Ben, for giving me the confidence I needed to get through this project and for helping me to remember what is truly important. CHAPTER I INTRODUCTION Management of oral contraceptives (DCs) among women represents a large part of primary care. Currently, there are approximately 18 million users of DCs in the United States, making DCs the most popular reversible method of birth control (Rosenberg, Bumhill, Waugh, Grimes, & Hillard, 1995). Df these 18 million users, 3.7 million have gone to their provider during the last year for their first prescription (Rosenberg et al., 1995). U nfortunatel y, the discontinuation rate among new users of DCs is more than 50% within the first year, with issues relating to side effects accounting for 75 % of the reasons for discontinuation (Hillard, 1992). Pratt and Bachrach (1987) found that only one third of these women were advised to discontinue taking DCs by their provider, whereas the remaining two thirds quit on their own initiative without informing their provider. Df the former users of DCs, 27% did not adopt any method of birth control after discontinuing their use and, in fact, continued to engage in unprotected intercourse (Pratt & Bachrach, 1987). The consequences of failure to use contraception include unplanned pregnancy with the concomitant emotional, social, and financial complications, as well as the morbidity and mortality, associated with it. Rosenfeld, Zahorik, Saint, and Murphy (1993) reported that 3 million unplanned pregnancies occur each year in the United States, which creates a significant problem in the population. OCs are a highly effective form of birth control with a typical failure rate of 3 % (Hatcher et al., 1994) . With today's available preparations containing low estrogen and progestin doses, approximately 90% of all women should be able to take at least one of the OCs without experiencing symptoms of menstrual irregularity, and 80% should be able to take OCs without noticing side effects of any type after the third cycle of use (Dickey, 1995). Therefore, because of the potential adverse effects on women's health associated with the discontinuation of OCs, prevention of discontinuation is possible and obligatory for primary care providers of women. Statement of the Problem 2 Avoiding pregnancy requires beginning use of a contraceptive at the right time and then using it consistently, correctly, and until a pregnancy is desired (otherwise known as "using the contraceptive compliantly"). According to Hillard (1992), two separate meanings can be attached to the word "noncompliant" with reference to OC use. One meaning involves the patient who is adversely affected by minor or nuisance side effects, poor cycle control, and fear of serious side effects and who decides to discontinue the use of OCs. The second meaning is often used to denote the patient who does not take OCs in a correct or consistent manner. That is, the user does not adhere to the manufacturer's recommended regimen that has been determined in controlled clinical trials to yield the maximum 3 efficacy of the formulation in question. In the present study, the former definition of noncompliance was to denote the patient who decides to discontinue DCs due to perceived adverse effects. For the most part, OCs must be taken long term; therefore, compliance issues related to OC use are similar to those involving chronic disease treatments. Treatment regimens often are inconvenient, complicated, and expensive, making compliance issues inevitable (Rosenberg, Waugh, & Long, 1995). Patient education is the key in assisting patients to overcome barriers to compliance of long-term medication use. Medical providers tend to focus more on the diagnosis and treatment than to provide education and follow-up with what happens after the prescription has been written. For example, Gilbert, Evans, Haynes, and Tugwell (1980) asked physicians to estimate compliance for patients they knew well; however, they were able to identify only 10% of patients who complied poorly. In addition, unique to DC use are the psychological and complex issues involving reproduction and contraception that complicate the matter of compliance even further. These personal priorities affect behavior, which change along with the life cycle. Consequently, providers must assess patients continually about perspectives that determine compliance. In summary, because of the nature of DC treatment, primary care providers must assess the patients' perspectives when introducing DCs, as well as long-term management, and they must provide the appropriate education and anticipatory guidance needed by each patient. 4 The experience of side effects by women using oes results in a significant rate of discontinuation (Balassone, 1989; Hillard, 1989, 1992; Morris, Mazis, & Gordon, 1977; Oakley, Sereika, & Bogue, 1991; Pratt & Bachrach, 1987; Rosenberg & Long, 1992). Based on these results, several researchers have focused on promoting the education of initial oe users regarding the expectations of side effects within the first 3 months of use (Balassone, 1989; Hatcher et al., 1994; Herold & Goodwin, 1980; Hillard, 1989, 1992; Morris et aI., 1977; Pratt & Bachrach, 1987; Rosenberg et al., 1995; Rosenberg & Long, 1992; Rosenfeld et al., 1993; Serfaty, 1992; Weisberg, 1995; Woods, Grace, Havens, Merola, & Emans, 1992). These researchers suggested that women's reactions to side effects in terms of discontinuation are predictable, and, through improving education, the discontinuation rates could be significantly improved. This theory, however, has not been scientifically evaluated. Despite these unanimous recommendations, recent data of oe compliance continue to show high rates of discontinuation due to the unexpected experience of, or fear of, side effects (Rosenberg et al., 1995). Perhaps one explanation of continual discontinuation because of side effects could be attributed to providers not educating patients appropriately despite these suggestions. For example, Herold and Goodwin (1980) found that only 3% of women had been told about side effects by their physician, whereas 51 % had received information from the media anu 49% had obtained it from girlfriends. In addition, women desire more information from their physician regarding the side effects of oes (Morris et al., 1977). Another explanation may be that providers 5 are educating patients properly but that the education does not influence compliance. As previously mentioned, efficacy of these recommendations in terms of improving compliance has not been evaluated. More importantly, no studies have been conducted that evaluate patients' perceptions of the other aspects of OC initiation education received from their provider that may have influenced compliance. Economic Costs The issue of women's satisfaction and, hence, compliance with OCs represents not only a quality-of-care concern among primary care providers but also one of economic costs. The potential consequences of improper use range from minimal side effects such as spotting or breakthrough bleeding to unintended pregnancy (Rosenberg et aI., 1995). In the United States, approximately 687,000 unintended pregnancies per year can be attributed to the discontinuation of OCs (Rosenberg et al., 1995). The direct costs of medical services for unintended pregnancy can include abortion, prenatal care, and delivery, as well as the indirect costs from work time lost or complications of pregnancy (Rosenberg et al., 1995). According to Rosenberg et al., if the rate of discontinuation among new OC users not intending pregnancy could be reduced by 10%, the number of unintended pregnancies would be decreased by 7 %, saving a significant amount in health care costs. The experience of side effects in women who have not been appropriately educated to the point of understanding also adds increased costs in medical care to the patient in terms of more potentially avoidable office visits (Hillard, 1992). Purpose of the Thesis Currently, there has been no research conducted that specifically focuses on the effect of education towards compliant OC use, as previously discussed. Therefore, the first step in this determination involves a retrospective study. The purpose of this thesis was to determine women's retrospective perceptions of the significance of education provided to them when initiating OCs for the first time. Specifically, is the education regarding the experience of side effects from the medication important in their perception of side effect severity and/or instrumental in affecting compliance? In addition, what other elements, other than side effect information, are important to patients in terms of affecting compliance? Answers to these questions could provide primary care providers with insight into the complex process of medication compliance with OCs. Evaluation of current research recommendations that support extensive side effect anticipatory guidance as a means of improving compliance also was measured, holding important implications for providers. Crucial educational needs of women initiating OCs are highlighted, which will create a directed educational outline for providers guided by what patients see as significant in determining compliance. This information can be used as a foundation for future research to evaluate OC-compliance issues. Based on the results of this study, the next step will involve prospective studies to measure direct effects of implementation of the results. 6 Research Questions of the Thesis Several answers to questions may offer insight into educational needs that determine compliance among OC users. The female subjects of this thesis experienced a structured education and follow-up program, and they were asked to review their experiences. The questions involved what they remembered when they first initiated oes in order to determine what was helpful or important to them. These research questions are as follows: 1. What side effects of oes do women recall experiencing? 2. To what extent do women's recalled side effects of oes match what they expected oe side effects to be? 3. What do women recall about the education they received when initiating oes for the first time? 4. What is the relationship between the perceived importance of education and side effect frequency and severity perceptions? 5. What is the relationship between the discontinuation of oes and recall of side effect frequency and severity perceptions? 6. What other recalled (nonside effect) education regarding oe use do women perceive as important in affecting compliance? 7 CHAPTER II REVIEW OF THE LITERATURE History of Oral Contraceptives The formulations used in today's combined DC pill are very different from the original pill first trialed in Puerto Rico in 1956 and introduced to the United States in 1960 (Hatcher et al., 1994). The estrogen concentration of DCs in 1960 was more than three to four times the dose of the current preparations (Hatcher et al., 1994). Even though wide acceptance among women and medical practitioners came immediately with the introduction of this method of birth control, enthusiasm began to decline within 5 years due to reports of adverse side effects and intolerance by women (Hatcher et aI., 1994; Pratt & Bachrach, 1987). Higher doses of estrogen were found to have increased rates of short-term minor side effects such as nausea, vomiting, and headache and long-term serious adverse effects such as thromboembolic disease and hepatic disorders (McLaurin & Dunson, 1991). Initial efforts at improved formulations in the 1970s and 1980s focused on a gradual reduction in the estrogen concentration to as low as 20 micrograms (mcg) of ethinyl estradiol. In 1988, the U.S. Federal Drug Administration (FDA) Fertility and Maternal Health Drugs Advisory Committee advised the FDA that high-estrogen (greater than 50 mcg) pills no longer be 9 marketed in the United States because they did not have sufficient clinical advantage to warrant continued availability for contraception (Edgren, 1991). During the 1990s, the estrogen level has been reduced by 80%, resulting in improved tolerability and very few adverse effects (Weisberg, 1995), The 1990s also have imprOVed the side effect profile of DCs with the addition of new types and concentrations of progestins (Hatcher et al., 1994). The androgenic effects of the progestins are the most intolerable and also lead to the most patient discontinuation such as weight gain, acne, hirsutism, and hypertension. The newer progestins have increased selectivity that lead to fewer androgenic side effects while maintaining contraceptive efficacy (Kaunitz, 1993). Composition of Today's Oral Contraceptives Two possible components of OCs are synthetic estrogen and synthetic progestin. The two estrogen types are ethinyl estradiol and mestranol; their concentrations in DCs can range from 20 mcg to 50 mcg (Dickey, 1995; Hatcher et al., 1994). Synthetic progestin consists of 12 possibilities, although not all are available in the United States The 5 synthetic progestins available in the United States are norethisterone, levonorgestrel, etynodiol, desogestrel, and gestodene (Lemke, Pattison, Marshall, & Cowley, 1995). The progestin doses in OCs can range from 0.75 to 10.0 milligrams (mg) in cOn'lbination OCs and from 0.05 to 1 mg in multiphasic OCs (Dickey, 1995). However, various types of progestins have differing levels of progestenic effects that depend on how long they suppress ovulation; therefore, they cannot be compared to each other in terms of mg to mg 10 equivalents. Additional variations are available in regimens of OCs, including (a) monophasic (constant dose of estrogen and progestin throughout the cycle); (b) biphasic (constant dose of estrogen but increasing the dose of progestin in the second half of the cycle); and (c) triphasic (constant dose of estrogen or increasing the dose in the middle of the cycle while the progestin dose is low initially and is increased throughout the cycle) (Dickey, 1995; Weisberg, 1995). Biolo2ical Activity of Oral Contraceptives The biological activities of OCs are the result of the combined activities of the estrogen and progestin components (Dickey, 1995). The wide variability of OC formulations of the doses of estrogen and progestin, as well as regimens, provides differing patterns of biological activity. This treatn1ent modality is beneficial, considering that all medications have different effects on different people. Therefore, most women are able to find a commercially available pill formulation that suits their particular needs (Weisberg, 1995). The generalized categories of biological effects are estrogenic activity, progestational activity, androgenic activity, endometrial activity, and the effect on serum lipoproteins (Dickey, 1995), The estrogenic activity exerts a contraceptive effect at the level of the hypothalamic-pituitary axis by suppressing follicle­stimulating hormone (FSH), whereas the progestational component suppresses luteinizing hormone (LH) (Hatcher et al., 1994). Endometrial effects include changes in tubal motility and ovum transport, decreased sperm penetration secondary to cervical mucous changes, and the prevention of implantation secondary to endometrial lining changes (Hatcher et al., 1994). The previous effects contribute to the effectiveness of Des as a contraceptive. Adverse Effects of Oral Contraceptives 11 Even though undesirable adverse effects may be minimized with the lower estrogen and progestin doses currently available in Des, some common side effects continue to occur, particularly in the first 3 months of use (Dickey, 1995). Side effects occur when the hormone activity of an De is much greater or much less than the hormone effect of a woman's own ovarian steroids (Dickey, 1995). The side effects from De use are similar to the effects of naturally occurring sex steroids produced by the ovaries. However, because the body is exposed to the steroids in Des in an unnatural way, the potential for side effects is increased. According to Dickey (1995), there are several mechanisms for side effects to occur. First, the steroids in Des enter the bloodstream through the gastrointestinal (GI) tract and into the portal vein, whereas ovarian steroids enter through the ovarian veins and bypass the liver. Therefore, women taking Des have higher levels of sex steroids in the GI tract and liver regardless of the De dose. Steroids within the liver can cause changes in blood-clotting components manufactured in the liver and within the GI tract can cause nausea and vomiting. Second, steroid blood-level patterns are different among De users and nonusers because Des provide one large dose per day rather than small amounts continuously produced by the ovaries throughout the day. Third, ovarian steroids are regulated by the pituitary but De steroids are not regulated. De steroids also 12 have a longer duration of action than ovarian steroids. In addition, unlike ovarian steroids, OC steroids have androgenic and antiestrogenic effects. Last, OC steroids react differently than ovarian hormones at steroid receptors. Appendix A describes common side effects that may be found in OC users. The side effects of excess parallel the symptoms and physiological changes associated with pregnancy, whereas the side effects of deficiency parallel the symptoms and physiological changes associated with pre- and postmenopause. Therefore, the frequency of these side effects differs among various OC preparations (depending on the estrogenic, progestenic, and androgenic activity of the formulation) and the woman's receptor activity. Research Studies Many research studies have been conducted that have shown the occurrence of side effects from OC use leads to dissatisfaction and discontinuation. For example, in one prospective study of 84 new OC users, 31 % had discontinued OCs within 3 months because of a specific side effect using the pill such as nausea and headache (Balassone, 1989). In another prospective study (Rosenfeld et al., 1993), 257 women were interviewed, with 220 using OCs as their form of birth control. Of these 220, 43 % stated that they were dissatisfied with their use, and nearly all of them mentioned side effects as the cause for dissatisfaction. In an additional study (Pratt & Bachrach, 1987), 46,684 former pill users were asked their reasons for discontinuation. Of these users, 100% cited a physical problem related to the pill, and 20% said that the problem was significant enough to discontinue OCs on their own accord. In the same study, 27 % of these women adopted no form of birth control following discontinuation but continued to engage in unprotected intercourse of which 17% became pregnant unintentionally. Contradictory to these findings, Neel, Litt, and Jay (1987) conducted a study that showed no relationship between the occurrence of side effects and the rate of discontinuation among adolescents. However, the design of the study was to follow-up with new users at 2 and 4 months. This design introduced an extraneous variable (follow-up) into the relationship of side effects and rate of discontinuation. Because follow-up is not always conducted in primary care upon DC initiation, the former study's relationship cannot be considered. 13 As a result of the repeated findings regarding side effects and DC discontinuation, the research suggests that increased patient education would help to increase compliance (Balassone, 1989; Hillard, 1992; Rosenfeld et aI., 1993; Serfaty, 1992). Several educational points were recommended to increase compliance. For example, Rosenberg et ala (1995) and Serfaty (1992) emphasized the importance of dispelling DC misinformation and discussion of the noncontraceptive benefits of DCs. Rosenberg et al. added that consideration of the patient's background, as well as individual needs and concerns, are extremely important for the provider to weigh when initiating DCs. Many authors suggested follow-up contact by phone or in the office at 3 months in order to evaluate consistency of use (Hillard, 1992; Rosenberg et al., 1995; Serfaty, 1992; Weisberg, 1995). The efficacy of these recommendations has not been evaluated. 14 Theoretical Framework The theoretical framework used for the foundation and guidance of this thesis was Leventhal's Common Sense Model (Leventhal, Meyer, & Nerenz, 1980). Application of this theory to the problem of DC noncompliance assisted in the understanding of why women make their decisions regarding DC use. The theory highlighted the important considerations a provider should take when attempting to change an individual's behavior. The underlying assumption of Leventhal's model (Leventhal et al., 1980) is that individuals make conscious decisions regarding their perceived health (Baumann, Cameron, Zimmermann, & Leventhal, 1989; Cameron, Leventhal, & Leventhal, 1993; Keller, Ward, & Baumann, 1989; Ward, 1993). Individuals' health perceptions are made on the basis of meanings they have constructed for their somatic experiences. In the theory of Leventhal et al. (1980), somatic experiences are perceived by individuals as health threats. A coping strategy is created to minimize a health threat and to improve one's health status. In this theory, the process of somatic experiences leading to meaning construction and, ultimately, behavior is termed the "self-regulating process." "Representation" is known, in this theory, as the first stage of the self­regulating process. In this stage, individuals organize, analyze, and interpret information of the perceived health threat. This representation is created through consideration of (a) labeling the symptom and its attributes, (b) perceiving the duration of the label and its symptoms, (c) perceiving consequences (short and long 15 term) of the label, (d) perceiving causes of the health problem, and (e) expectations about controllability of the label and symptoms. This cognitive and emotional process is made based on an individual's bodily symptoms and sensations, previous experiences with the symptoms, and the environment (including interaction with health care providers) whether those ideas are medically sound or not. This representation is, therefore, different in each individual regardless of similarities in symptoms between individuals. For example, if two women were to begin taking OCs, they would have two different representations of the experience. That is, they have had different histories surrounding somatic experiences and different informational sources that define their individual preconception of OC use. When one woman experiences breakthrough bleeding as an OC side effect and depending on her history and preconceptions, she might represent this bodily sensation as a sign of uterine cancer. The second woman who has had a different history and preconception might represent the same breakthrough bleeding as an expected and transient side effect of OC use. In the theory of Leventhal et al. (1980), following the representation, the individual then progresses through a second stage known as "coping." Coping involves the selection and execution of a response or behavior to the representation, which is dependent upon the individual content of the representation. Using the same two women as examples, the first woman who made the representation of breakthrough bleeding to indicate uterine cancer most likely would cope with that health threat by stopping the OCs, whereas the second 16 woman who views the somatic sensation as benign would continue the use of OCs. The final stage in the theory of Leventhal et al. (1980) is known as "appraisal." This stage involves the evaluation of the effectiveness of an individual's coping responses. The effectiveness is measured in movement closer to or farther away from one's desired outcome of improved health status. This continual evaluation may alter coping responses or even the representation itself. The first woman saw that in stopping her OCs that her breakthrough bleeding also had stopped. The threat of uterine cancer was gone, and, therefore, she had made the correct decision to discontinue. The second woman, in continuing her OCs, eventually experienced cycles without breakthrough bleeding and concluded that she was correct in her decision to continue. The key to this theory that made the purpose of this thesis important is the idea that providers can influence individuals in the outcome of this self-regulating process. Providers have the potential to change an individual's representation and, hence, behavior through appropriate education and guidance. This concept and theoretical framework provided the basis for the design, methods, and results of this thesis. CHAPTER III METHODOLOGY Research Desi2n A descriptive design was used in this study that focused on women's retrospective perceptions. Data were collected using a questionnaire I developed. The independent variable measured is an established educational protocol used by Planned Parenthood (see Appendix B). Dependent variables measured included (a) demographics, (b) women's recalled side effects from OCs of the frequency and levels of severity, (c) education recall, and (d) levels of perceived importance of recalled education as they relate to influencing OC compliance. Settin& and Sample A convenience sample of healthy women who were new OC users was used. The subjects had initiated their OCs at the Planned Parenthood Association of Utah in Salt Lake City, and they had continued to seek care at this clinic at the time of data collection. They had started on OCs for the first time in less than 2 years, and they had continued or discontinued their use for reasons other than the provider recommending discontinuation. The subjects were between the ages of 18 and 45, which were established as the age parameters. The lower parameter was established because noncompliance with OCs in adolescents is often for different 18 reasons than in adults (Herold & Goodwin, 1980). The higher parameter was established because older women are at higher risk for adverse side effects from OCs and, therefore, have different reasons for discontinuation (Dickey, 1995; Hatcher et al., 1994). In the present study, the women also were not on any other long-term medications (more than 2 weeks) during their OC use because of the potential for an extraneous variable contributing to side effects. The Planned Parenthood Association of Utah (1996) is a nonprofit family planning clinic that provides many services, including OC initiation, education, and management. The clinic is managed by nurse practitioners and nurse midwives in which clients are encouraged to see the same provider each visit. A documented protocol of provider education is implemented at the Planned Parenthood Association of Utah for patients initiating OCs (see Appendix B). All points of education are documented and initialled by the patient, ensuring that consistent education is provided. This information provided variable control and an objective basis for consistency, which helps to support any relationships that may be suggested from the results of the study. Instruments and Procedures Approval from the Planned Parenthood Federation of America was sought prior to initiation of this study. Upon approval, an informational in-service was provided by the investigator to the staff of the Planned Parenthood Association of Utah to familiarize the staff with the study. 19 Following Institutional Review Board approval, data collection began. As a means of subject recruitment, a subject Criteria Outline (see Appendix C) was designed. This form was attached to the front of the patient's chart at the time of visit to the clinic. The provider seeing the patient indicated if the patient met the minimum subject criteria by checking "yes" or "no." I collected the Criteria Outlines while the patient was being seen by the provider. As the patient exited Planned Parenthood, I asked for her participation in the study. A brief explanation of the study was given at this time, along with an explanation of the anonymity and voluntary nature of participation. The potential subject was given a cover letter (see Appendix D) to read and keep that further described participation guidelines. If the subject agreed to participate, she was given a questionnaire (see Appendix E). The subject was given the option of completing the questionnaire while at the clinic, returning it to me the same day, or completing it at a later date and mailing it back to me in a provided, self­addressed, stamped envelope. A three-part questionnaire was developed (see Appendix E). The first part of the questionnaire measures demographic information and history of OC use. The second part of the questionnaire measures recalled frequency and the severity of side effects from OCs (answered on a 0- to 4-point Likert scale). In addition, three columns appear alongside each side effect, indicating if the side effect was discussed with the provider, if the side effect was unexpected, and if the side effect led the woman to stop taking OCs. The third part of the questionnaire measures frequency of recalled educational points, as well as another 5-point Likert scale, which rates the importance to compliance of the educational point remembered. Data Analysis Data from the questionnaire were quantitative. These data were analyzed using software from the Statistical Package for the Social Sciences (SPSS), including frequency distributions, two-tailed! tests, and Pearson's r correlation. The alpha was set at .05 to determine significant relationships. Frequencies including central tendencies and variability were computed for demographic data, De use among the sample, side effect experiences and severity, side effects discussed with the provider, side effects expected, side effects that caused discontinuation, educational points remembered, and educational importance 20 scores. I tests were calculated between follow-up appointment and total side effect severity score, side effect severity score and expectedness, educational points remembered and length of time on Des, discussion of side effects and length of time on Des, continuers' side effect severity score and discontinuers' side effect severity score, continuers' educational importance total score and discontinuers' educational importance score, and educational points not remembered for continuers and educational points not remembered for discontinuers. Pearson's r computation was used to determine relationships between total side effect severity score and education importance score among the sample and length of time on Des and total side effect severity score. CHAPTER IV RESULTS The characteristics of the sample and the results of the data analysis are presented in this chapter. The analyses are introduced as they relate to the research questions of the thesis. For all inferential statistics, the alpha level was set at .05. Missing values were coded as such and, therefore, were not included in the analysis of individual variables. The number of missing cases is indicated for each analysis. Sample Thirty-eight women at Planned Parenthood, who met the inclusion guidelines according to the Criteria Outline provided to the staff, completed the questionnaire. All of the questionnaires were completed at the study setting. Upon initial review of the questionnaires returned, eligibility was reassessed based upon the subjects' responses to the criteria guideline questions within the questionnaire. Eight completed questionnaires were excluded from subsequent analysis because of responses to the eligibility critelia questions; 3 were excluded because subjects reported starting on OCs more than 2 years previously; and 5 were excluded because subjects reported prescription medication use of longer than 2 weeks while on OCs. The remaining 30 questionnaires were included in the 22 final data analysis. Characteristics of the Sample The sample was mostly young, single, Anglo American, and well-educated, with a variety of religious affiliations (see Table 1). Twenty (66.6%) of the subjects were current OC users and 10 (33.3%) had used OCs within the past 2 years, but had discontinued them. The mean amount of time since the subjects began taking OCs was 13.5 months (SD = 7.977), with a range of 1 to 24 months (see Figure 1). The mean amount of time that the subjects had taken OCs continuously within the last 2 years was 10.321 months (SD = 8.692), with a range of 1 to 24 months (see Figure 2). Subjects who had discontinued OC use had a mean of 5.6 months (SD = 4.971), with a range of 0 to 12 months prior to completing the questionnaire (see Figure 3). Research Question One The first research question was to determine the side effects of OCs women recalled experiencing. Eighteen commonly experienced side effects of OCs were listed on the questionnaire. Subjects were asked whether or not they remembered if they had experienced each of the side effects. Out of 538 answers (2 missing), only 5 (.01 %) responses were "don't remember." Subjects were asked to rank each side effect on a Likert scale from 0 to 4 (0 = did not experience that side effect, 1 = remember to be slightly bothersome, 2 = remember to be moderately severe, 3 = remember to be quite severe, and 4 = remember to be extremely 23 Table 1 Demographic Data (N = 30) Frequency Percent Age 18-22 18 60.0 23-27 9 30.0 28-32 3 10.0 Marital status Married 8 26.7 Single 18 60.0 Divorced 1 3.3 Separated 0 0.0 Live with partner 3 10.0 Ethnicity Anglo American 26 86.7 Hispanic American 2 6.7 African American 0 0.0 Asian American/Pacific Islander American 0 0.0 Native American 1 3.3 (Missing) 1 3.3 Religion Catholic 6 20.0 LDS 10 33.0 Jewish 0 0.0 Protestant 1 3.3 None 10 33.0 Other 3 10.0 Educational level Less than high school 2 6.7 High school graduate 4 13.3 Some college 16 53.3 Two-year college degree 0 0.0 Bachelor's degree 6 20.0 Graduate degree or higher 2 6.7 24 n~------------------------------------------~ 8 6 4 2 c 8 0 rro1hs Fi~ure 1. Time since subjects began taking oral contraceptives (N = 30). 8 7 6 5 4 3 2 C 1 c§ 0 - Missirg 2 4 6 11 t3 1 3 5 7 12 14 rronths Fi~ure 2. Time subjects had taken oral contraceptives continuously (N = 30). 25 26 3.5~------------------------------------------~ 3.0 2.5 2.0 15 10 .5 7 rronths Figure 3. Time subjects had stopped taking oral contraceptives prior to completing questionnaire (n = 10). 27 severe). For each side effect, the incidence of experience of that side effect was computed (see Table 2). Then mean severity scores for each ranked side effect were computed; a response of 0 or did not experience was excluded in computing the mean. The side effects with the highest mean severity were (a) mood changes, (b) headache, (c) decrease in sex drive, and (d) fatigue. The side effects most often experienced were (a) weight gain, (b) mood changes, (c) headache, and (d) bloating. In order to examine the strength of the relationship between length of time on Des and severity of side effects experienced, Pearson's r was computed. For each subject, side effect severity scores were added for the total side effect severity score. The subject's total score was compared to length of time on Des, which was coded according to how long the subject said she had taken Des continuously. There were 2 missing cases for length of time of De use for this analysis (n = 28). There was a moderate negative correlation (r = -.2891, R = .121) between side effect severity and length of time on Des that was not statistically significant. In addition, the subjects were asked if they had a follow-up appointment 3 months after beginning Des for the first time (yes/no). Sixteen subjects (53.3%) indicated that they had attended a follow-up appointment, 13 (43.3%) responded that they had not attended this appointment, and 1 (3.3%) did not remember. Subjects were grouped by follow-up appointment, with the groups being compared on mean total side effect severity scores using a two-tailed 1 test. No difference 28 Table 2 Side Effect Incidence and Mean Severity Scores8 Side effects Incidence (%) M severity SD N answered Mood changes 50.0 2.73 1.10 30 Headache 50.0 2.67 1.11 30 Decrease in sex 23.0 2.57 1.27 29 drive Fatigue 37.0 2.18 1.08 30 Appetite changes 37.0 2.27 .91 28 Nausea 50.0 2.13 1.13 30 Breast changes 43.0 2.08 .86 30 Increase in sex 17.0 2.00 .71 29 drive Skin changes 10.0 2.00 0.00 30 Visual changes 10.0 2.00 0.00 28 Acne 40.0 1.92 .79 30 Weight gain 67.0 1.85 .99 30 Bloating 50.0 1.80 .76 30 Oily skin 33.0 1.70 .82 29 Menstrual 37.0 1.54 .69 30 irregularity Menstrual cramps 47.0 1.50 .76 30 Vomiting 20.0 1.33 .82 30 Hair changes 10.0 1.00 0.00 30 a Arranged in descending order by severity. was found in side effect severity by follow-up appointment status (1 = -.40, df = 25.5, 12 = .694). Research Question Two 29 The second research question addressed the relationship between recalled side effects (expected and unexpected). On the questionnaire next to each of the 18 listed side effects, women were asked to check a column if that side effect was expected or unexpected. Frequencies were computed to determine the number of side effects expected versus unexpected (see Table 3). Percentages were calculated based upon the number of subjects who answered that question; missing cases were subtracted. The results showed that the majority (more than 50 %) of the side effects was expected. The most frequently unexpected side effects were nausea, headache, weight gain, fatigue, and mood changes. In order to determine if side effect severity scores differed between unexpected side effects and expected side effects, a two-tailed 1 test was used to calculate the significance of this difference (see Table 4). For each side effect, subjects were grouped on expecting or not expecting the side effect, and the mean level of side effect severity was compared between the groups. This analysis showed that the nlajority (12 of 14, or 86%) of the side effects had a significantly higher mean severity score (12 < .05) when that side effect was unexpected. Therefore, the women who did not expect to experience a particular side effect tended to rank that side effect higher in severity than those who expected the side effect. The only two side effects that did not show a significant difference 30 Table 3 Frequencies of Side Effects Expected or U nexpected8 Side effects Expected oN (%) Unexpected N (%) oN answered (%) Headache 11 ( 55) 9 (45) 20 (67) Nausea 11 ( 55) 9 (45) 20 (67) Weight gain 14 ( 64) 8 (36) 22 (73) Fatigue 11 ( 65) 6 (35) 17 (57) Acne 12 ( 67) 6 (34) 18 (60) Mood changes 14 ( 67) 7 (33) 21 (70) Bloating 13 ( 68) 6 (32) 19 (64) Appetite changes 14 ( 70) 6 (30) 20 (66) Oily skin 13 ( 76) 4 (24) 17 (57) Vomiting 13 ( 76) 4 (24) 17 (57) Menstrual cramps 17 ( 81) 4 (19) 21 (70) Decrease in sex drive 14 ( 82) 3 (18) 17 (57) Menstrual irregularity 17 ( 85) 3 (15) 20 (66) Breast changes 19 ( 91) 2 ( 9) 21 (70) Increase in sex drive 13 ( 93) 1 ( 7) 14 (47) Skin changes 12 ( 92) 1 ( 7) 13 (43) Visual changes 12 ( 92) 1 ( 7) 13 (43) Hair changes 12 (l00) o ( 0) 12 (40) 8 Arranged in descending order for unexpectedness. 31 Table 4 T-Test R~sults for Relationshi:a B~tween Total Side Effect Severit~ Score and Exnectedness Versus Unexnectedness of That Side Effect Side effects ! value df IS. M severity for M severity for expected side unexpected effect side effect Breast changes 1.78 19 21 1.00 2.50 .092 Menstrual irregularity -.36 18 20 .88 .67 .723 Menstrual cramps .74 19 21 .65 1.00 .467 Appetite changes 2.63 18 20 .57 2.17 .009 Weight gain 4.28 20 22 .79 2.50 .000 Fatigue 5.44 15 17 .45 2.50 .000 Decrease in sex drive 5.43 14 16 .46 3.67 .000 Increase in sex drive § 13 Oily skin 4.49 14 16 .25 1.50 .001 Acne 6.80 16 18 .25 2.17 .000 Bloating 3.97 17 19 .69 2.17 .001 Nausea 3.71 18 20 .55 2.33 .002 Vomiting 2.58 15 17 .16 .75 .021 Headache 2.89 18 20 .91 2.67 .010 Mood changes 4.70 19 21 .71 3.14 .000 Hair changes § 12 Skin changes § 13 Visual changes § 12 §Value could not be computed due to insufficient responses of unexpectedness of that side effect or all severity scores were zero. (n > .05) were menstrual irregularity and menstrual cramps (n = .723 and 11 = .467, respectively). Research Question Three 32 The third research question was, "What do women recall about the education they received when initiating Des for the first time?" The educational points included in the Planned Parenthood De initiation protocol (see Appendix B) were listed in part three of the questionnaire. The subjects were asked to indicate whether or not they remembered being taught each educational point. Frequencies of educational points remembered and not remembered were computed (see Table 5). All of the educational points were remembered by a majority of the sample. The educational points remembered by more than 90% of the subjects were "instructions regarding how to take Des," "need for follow-up yearly physical exam," "the effectiveness of Des," and "use of Des does not protect you from some sexually transmitted diseases." The educational points that were not remembered by the sample were "not to stop taking Des during the first 3 months unless notify health care provider," "risks of using Des," and "do not take Des if you think you may be pregnant." In order to determine if length of time on Des differed between subjects who did and who did not remember each educational point, two-tailed 1 tests were computed (see Table 6). No statistically significant differences were found between the subjects who did and who did not remember each educational point for months on Des. Because very few subjects did not recall specific points and the 33 Table 5 Frequencies of Educational Points Remembered and Not Remembereda Educational points Remembered (%) Not remembered (%) N (%) Instructions regarding how to take 29 (97) 1 ( 3) 30 (100) BCPs Need for follow-up yearly for 28 (94) 2 ( 6) 30 (100) physical examination Effectiveness of BCPs 27 (93) 2 ( 7) 29 ( 97) Use of BCPs does not protect you 27 (93) 2 ( 7) 29 ( 97) from some sexually transmitted diseases Benefits of using BCPs 26 (90) 3 (10) 29 ( 97) Danger signs of severe side effects 27 (90) 3 (10) 30 (100) from BCPs Interaction of BCPs with other 27 (90) 3 (10) 29 ( 97) medications Interaction between smoking and 27 (90) 3 (10) 30 (100) taking BCPs Do not take BCPs if you believe you 26 (87) 4 (13) 30 (100) may be pregnant Risks of using BCPs 25 (84) 5 (17) 30 (100) Not to stop taking BCPs during the 18 (60) 12 (40) 30 (100) first 3 months unless you notify health care provider a Arranged in descending order for unexpectedness. Note. BCPs = birth control pills. 34 Table 6 T-Test Results Com12aring Educational Points Remembered and Not Remembered To Length of Time Took Oral Contrace12tives Educational points ! value df N M time if M time if not l! remembered remembered Benefits of using BCPs 1.21 25 27 10.50 4.30 .239 Risks of using BCPs 1.36 26 28 11.35 5.60 .185 Effectiveness of BCPs 1.28 25 27 11.16 3.00 .212 Use of BCPs does not 1.11 25 27 10.32 3.50 .279 protect you from some sexually transmitted diseases Instructions regarding § who to take BCPs Interaction between 1.16 26 28 10.50 4.00 .257 smoking and taking BCPs Do not take BCPs if you 1.28 26 28 10.85 3.50 .213 think you may be pregnant Not to stop taking BCPs 1.20 26 28 11.04 4.33 .241 during the first 3 months unless you notify health care provider Danger signs of severe -.07 26 28 11.78 7.70 .944 side effects from BCPs Need for follow-up .90 26 28 10.28 10.67 .379 yearly for physical examination Interaction of BCPs with 1.35 25 27 10.73 5.00 .189 other medications §Value could not be computed due to insufficient responses of unexpectedness of that side effect or all severity scores were zero. Note. BCPs = birth control pills. overall sample was small, these findings should be interpreted cautiously. Whether or not a woman remembered discussing a side effect with her provider also was considered part of the education received. In addition to rating side effect severity on part two of the questionnaire, subjects were asked to indicate whether or not they had discussed that side effect with their provider. Frequencies were conlputed for each side effect discussed with the provider and 35 not discussed with the provider (see Table 7). The percentage of women who recalled discussing each specific side effect was less than 50 % . The side effects subjects most frequently discussed with their provider were (a) headache, (b) menstrual cramps, (c) weight gain, and (d) menstrual irregularity. Side effects that most often were not discussed with their provider were (a) acne, (b) bloating, and (c) oily skin. Again, in order to determine whether months on DCs was related to whether or not side effects were discussed with the provider, a two-tailed ! test was computed (see Table 8). No statistically significant differences were found, suggesting that the amount of time the women had taken DCs continuously did not differ by recall of discussion of specific side effects. Research Question Four Correlational analysis and examination of differences between groups were used to answer the fourth research question, "What is the relationship between the perception of educational importance and side effect frequency and the severity of perceptions?" In part three of the questionnaire, women were asked to rate each 36 Table 7 Fr~uencies of Side Effects Women Remember Discussing With Their Provider and Not Discussinga Side effects Discussed with Not discussed with N = answered (%) provider (%) provider (%) Headache 11 (44) 14 (56) 25 (83) Menstrual cramps 10 (40) 15 (60) 25 (83) Weight gain 11 (39) 17 (61) 28 (93) Menstrual irregularity 9 (38) 15 (63) 24 (80) Appetite changes 9 (36) 16 (64) 25 (83) Skin changes 7 (35) 13 (65) 20 (67) Nausea 8 (31) 18 (69) 26 (87) Fatigue 7 (30) 16 (70) 23 (77) Hair changes 6 (30) 14 (70) 20 (67) Vomiting 7 (29) 17 (71) 24 (80) Increase in sex drive 6 (29) 15 (71) 21 (70) Visual changes 6 (29) 15 (71) 21 (70) Mood changes 7 (27) 19 (73) 26 (87) Breast changes 7 (26) 20 (74) 27 (90) Decrease in sex drive 6 (26) 17 (74) 23 (77) Oily skin 5 (23) 17 (77) 22 (73) Bloating 5 (21) 19 (79) 24 (80) Acne 4 (17) 19 (83) 23 (77) a Arranged in descending order for discussion with provider. 37 Table 8 T-Test Results of Discussing Side Effect With Provider or Not and Length of Time on Oral Contracentives Side effects ! value df N M time if M time if not I! discussed discussed Breast changes -2.01 24 26 4.43 11.63 .055 Menstrual irregularity -.14 21 23 8.78 9.23 .893 Menstrual cramps .33 21 23 10.60 9.31 .741 Appetite changes -.69 22 24 7.67 10.13 .496 Weight gain -.19 24 26 8.91 9.53 .850 Fatigue -.66 20 22 7.43 10.67 .519 Decrease in sex drive .11 20 22 8.67 8.25 .917 Increase in sex drive -.11 18 20 8.33 8.79 .915 Oily skin .21 19 21 9.20 8.31 .839 Acne .60 20 22 10.75 7.89 .583 Bloating .03 21 23 9.20 9.06 .974 Nausea -.65 23 25 7.88 10.17 .525 Vomiting -.54 21 22 7.29 9.25 .596 Headache .58 22 24 10.00 8.00 .570 Mood changes -.40 23 25 8.00 9.50 .690 Hair changes -.06 17 19 8.33 8.61 .949 Skin changes -.59 17 19 7.57 10.00 .562 Visual changes -.02 18 20 8.33 8.43 .982 educational point they remembered being taught about its importance in making their decision to continue taking oes. This response was measured on a Likert scale from 0 to 4 (0 = not at all important to me in my decision to take, 38 1 = slightly important to me in my decision to take, 2 = moderately important to me in my decision to take, 3 = quite important to me in my decision to take, and 4 = extremely important to me in my decision to take). A combined total for each subject was computed to create an educational importance score. The strength of the relationship between the total educational importance score and the subject's total side effect severity score was computed using Pearson's I (see Figure 4). The correlation was I = -.4815 (p = .007). Therefore, a significant inverse relationship was shown; that is, as the side effect severity total score increased, the total educational importance decreased. A two-tailed 1 test was computed to determine if recall of side effects discussion was related to level of side effect severity. Subjects were grouped by their responses to the side effect discussion status (yes/no). The dependent variable was the side effect severity score (see Table 9). Bloating was the only side effect shown that had a statistically significant (p = .027) higher side effect severity score for subjects who did not recall discussing it with the provider compared to subjects who did recall discussing it. Research Question Five "What is the relationship between the discontinuation of oes and recall of side effect frequency and severity?" was the fifth research question to be answered. •• •• • • Cl) 0 ".. ..ca..s.:. • s0.. . • cE.. •• • c0: • • • :;a:s; • 0 ~ "C • Cl) -..a..s.. ..0... . -1) -1) 0 1) 20 30 40 total side effect severity Figure 4. Pearson's r scatterplot graph: Relationship of total educational importance score and total side effect severity score. 39 40 Table 9 T -Test Results of Discussion of Side Effect With Side Effect Severity Score Side effects ! value df N M time if M time if not I! discussed discussed Breast changes -.71 25 27 .71 1.10 .495 Menstrual irregularity -1.12 22 24 .44 .87 .278 Menstrual cramps -.60 23 25 .71 .93 .556 Appetite changes -.31 22 24 .89 1.07 .757 Weight gain -.04 26 28 1.27 1.29 .965 Fatigue -.73 21 23 .71 1.19 .483 Decrease in sex drive -.89 20 22 .33 .94 .384 Increase in sex drive .32 18 20 .50 .36 .750 Oily skin -1.33 19 21 .20 .81 .198 Acne -1.89 21 23 .00 1.05 .073 Bloating -2.37 22 24 .20 1.37 .027 Nausea -.93 24 26 .75 1.28 .363 Vomiting -1.64 22 24 .00 .29 .116 Headache -.04 23 25 1.55 1.57 .969 Mood changes -1.17 24 26 .86 1.68 .252 Hair changes -.95 18 20 .00 .15 .355 Skin changes -.72 18 20 .00 .16 .478 Visual changes 1.59 18 20 .33 .00 .130 Subjects were separated into two groups: (a) those who continued to be on oes and (b) those who had previously discontinued their oe use. The discontinuers (n = 10, 33.3 %) were asked why they stopped taking oes. Responses were categorized and coded. Four (40%) of the women stated that they discontinued their oes due to side effects, 2 (20 %) stopped oes in order to change to a different contraceptive, 1 (10%) had just forgotten to take them, 1 (10%) was no longer sexually active, 1 (10%) did not like oes, and 1 (10%) did not respond. 41 Women who had discontinued taking oes also were asked to indicate which side effect caused them to discontinue the medication. Frequencies were computed for each side effect that caused discontinuation (see Table 10). The most frequently cited side effects that led to discontinuation were headache, mood changes, nausea, weight gain, and decrease in sex drive. The oe continuers were compared to oe discontinuers in terms of frequency of side effect severity scores, educational importance scores, and educational points not remembered using two-tailed! tests (see Table 11). The mean total side effect severity score was not statistically significant (n = .065) by difference between the groups. Educational importance mean scores were higher for continuers than discontinuers (n = .026), and continuers remembered more educational points than discontinuers as well (n = .027). Research Question Six The sixth and final study question was to determine what other education regarding oes women perceived as important. For this question, mean importance 42 Table 10 Frequency of Side Effects That Caused Discontinuationlt Side effects Frequency (N) Headache 5 Mood changes 4 Weight gain 3 Decrease in sex drive 3 Nausea 3 Breast changes 2 Fatigue 2 Menstrual irregularity 1 Menstrual cramps 1 Appetite changes 1 Acne 1 Bloating 1 Skin changes 1 Visual changes 1 Increase in sex drive 0 Oily skin 0 Vomiting 0 Hair changes 0 Table 11 Difference Between Oral Contraceptive Continuers and Discontinuers M 1 value I test comparing continuers to discontinuers for total side effect severity scores Continuers Discon tin uers I-test results Continuers Discon tin uers I-test results 9.05 16.25 6.97 12.43 -1.93 I test comparing continuers to discontinuers for total educational importance scores 28.05 18.75 8.62 10.95 2.37 I test comparing continuers to discontinuers for M number of educational points not remembered Continuers Discontinuers I-test results 0.6 1.9 .25 .8 2.35 .065 .026 .027 43 44 scores were calculated for each educational point taught to the subjects (see Table 12). The highest scoring educational points included effectiveness of DCs, need for follow-up yearly examination, non contraceptive benefits of using DCs, and risks of using DCs. Table 12 Mean ImQortance Score of Educational Points8 Educational points M SD N Effectiveness of BCPs 3.56 .70 29 Need for follow-up yearly for physical 3.21 1.29 30 examination Benefits of using BCPs 3.19 1.17 29 Risks of using BCPs 2.72 1.31 30 Instructions regarding how to take 2.55 1.72 30 BCPs Danger signs of severe side effects 2.33 1.57 30 from BCPs Use of BCPs does not protect you from 2.26 1.66 29 some sexually transmitted diseases Interaction of BCPs with other 2.15 1.64 29 medications Not to stop taking BCPs during the 2.06 2.01 30 first 3 months unless you notify health care provider Do not take BCPs if you think you may 1.85 1.76 30 be pregnant Interaction between smoking and taking 1.82 1.84 30 BCPs Note. BCPs = birth control pills. CHAPTER V DISCUSSION In this chapter, a discussion of the data analysis results presented in Chapter IV is provided. The research design is evaluated and discussed. Then a brief explanation of the usual care pattern of OC initiation at Planned Parenthood Association of Utah is provided. The results of the research question data analysis are examined, organized by the general subjects of side effects and education. Possible explanations for the findings are explored next. Finally, a discussion of possible nursing implications based on the study findings, as well as recommendations for future studies, are addressed. Study limitations are considered and mentioned as part of this discussion. The purpose of this study was to determine women's retrospective perceptions of the significance of education provided to them with respect to their experiences of OC use. In other words, how did the women perceive their somatic experiences of side effects from OCs (their representation), and did the interaction with the provider through education influence these perceptions (change their representation, coping, or appraisal behaviors)? 46 Desi::D This research study used a nonexperimental, descriptive design. Because of this design, without manipulation, control, or randomization, the generalizability of the results is extremely limited. However, the goal of the study was to describe these women's perceptions, not to evaluate any particular intervention. This approach is the first step in exploring the relationship between OC use, side effects, and perception of provider behavior. The retrospective descriptive design was appropriate for this purpose. This study was retrospective because women were asked to recall events that had occurred up to 2 years prior to the study. Therefore, results are vulnerable to recall bias. In order to compensate for this limitation, only women who had started on OCs within the previous 2 years were included in this study to limit the time frame for recall. In the data analysis, the length of time on OCs was not related to total side effect severity score. In addition, length of time on OCs did not nlake a difference in recall of education. These findings suggest that elapsed time did not influence recall. Another limitation to this study and the results is the instrument used for data collection. The questionnaire was developed by the investigator for the purpose of this study; therefore, reliability and validity have not been established. Likert scores were used to measure side effect severity and educational importance perceived by the subjects, which is one of the most widely used scaling techniques (Polit & Hungler, 1995). Attention was paid to the readability and level of 47 vocabulary used. The option was given to have the questionnaire read to the subject, if desired; however, none of the subjects opted for this administration procedure. There were very little missing data, which helped to strengthen the results and conclusions. The instrument achieved good subject acceptance, but the lack of reliability and validity data should be considered a limitation. The sample in this study was fairly homogeneous, which included an already narrow population and nonprobability sampling procedure. In addition, this factor limits the generalizability of the results. The setting was selected to sample from because of the extensive standard teaching protocol for all women initiating DCs and documentation of the protocol. This study also provided a form of control because it could be assured that all women in the sample had the same education. Consistency in practice was essential in order to limit variation in practice as an explanation for variance in women's recollections of education. The intent of this study was not to generalize but rather to describe the recollections and perceptions of women in a single practice setting about their experiences with DCs. This information will provide a basis for future studies of DC compliance issues and the influence of patient education. Usual Care Pattern In order to put the results and discussion of them into perspective, it is important to outline the usual care pattern that a woman experiences at Planned Parenthood Association of Utah when initiating DCs for the first time. When a woman initiates DCs at Planned Parenthood Association of Utah, she is first 48 educated regarding oes by a medical assistant using the Planned Parenthood oe Education Practice Standards and Protocols (see Appendix B). At this time, each point on the practice standards is reviewed and initialed by the patient. The education on the practice standards that addresses side effects are as follows: "I understand that some minor reactions to the pill may include nausea, vomiting, breast tenderness, weight gain or loss, and spotting between periods." Written materials are given; then the woman initials the practice standards to indicate that she received the written information. The written materials given include (a) the Planned Parenthood Federation Association brochure on oes, including the efficacy of oes, common side effects, dangerous adverse effects, and how to take Des (see Appendix F); and (b) the Food and Drug Administration pamphlet provided by the pill manufacturer. All side effects included on the questionnaire also are contained on the written brochure except for decrease in sex drive, appetite changes, increase in sex drive, visual changes, menstrual cramps, and hair changes. Following this education, the woman is seen by the provider for a physical examination. Then a prescription for the oe is given for 12 months. The woman is encouraged to return to the clinic in 3 months for a blood pressure check. This visit is not charged to the patient as long as she does not need a physical examination. At this 3-month follow-up visit, the medical assistant sees the patient, checks her blood pressure, and answers any questions she may have about oes. No current practice standard or protocol is available other than for the follow-up visit in which education is provided. If the woman does not return for a 49 follow-up visit, there is no consequence such as no refill on the De prescription. The woman is required to return to the clinic in 12 months for a complete physical examination by the provider if she desires to continue the Des; otherwise the pill prescription will not be refilled. Side Effects Research Questions 1, 2, and 3 were concerned with describing the experiences of side effects among the sample. The results indicated that the sample was able to recall nearly all of the side effects, with only .01 % of the responses as "don't remember." The incidence of side effect experienced ranged from 1 0 % to 67 % of the sample. All of the side effects had been experienced by at least 1 subject. Subjects who experienced side effects perceived them to be moderately severe, with mean severity scores between 1 and 2.73 and an overall mean of 1.96. In this sample, side effect severity perception did not differ by whether or not the subject attended a follow-up examination after initiating Des. The greatest severity of the side effects (mood changes, headache, decrease in sex drive, and fatigue) fell into the category of progestin excess (Dickey, 1995). Perhaps this result was from this particular clinic preferring to use a specific preparation of Des for first initiators, which tends to have high progestin activity. Because data for the specific De prescribed were not available, the relationship between progestin dose and specific side effects could not be examined. In future research studies, pharmacy records could be used to obtain accurate data for comparing preparations of side effects experienced. 50 Perhaps the most significant finding of this research study was that the subjects rated the severity of their side effects significantly higher if that side effect was unexpected. In spite of this, most of the side effects were found to be expected, with a range of 55 % to 100 % . This finding supports the fact that the subjects' side effect experiences generally tended to match what they had previously conceived their OC side effects to be. However, when a side effect was experienced that did not match what the subjects expected, they perceived that side effect to be higher in severity than those who expected and experienced the same side effect. The side effects rated as most severe by the subjects also were the most frequent causes for discontinuation based on that side effect. Discussion of the side effects with the provider was low, with a range of 17 % to 44 % of the side effects discussed with the provider. Discussion of a side effect with the provider did not change the total side effect severity score. Explanations for these results are discussed further in this chapter. Education Research Questions 3 and 6 measured the education recall and education importance of the subjects. Most of the educational points were remembered by the women of the sample regardless of how long it had been since starting OCs. Between 60% and 97% of the educational points were recalled by the sample. These data are encouraging, suggesting that most of the education was remembered for at least the first 2 years following instruction. The most frequently recalled 51 educational points were the most practical and necessary such as (a) instructions on how to take oes, (b) the need for a follow-up yearly examination in order to renew the oe prescription, (c) the concept that oes do not guarantee protection from sexually transmitted diseases (condoms should be used), and (d) the effectiveness rate of oes. Even though recall of this information does not equate to behavior, it does indicate that subjects were aware of important elements of the educational program. The educational point remembered by the fewest subjects was not to stop taking oes within the first 3 months without notifying the provider. On the written informational brochure, a statement is presented under the listing of side effects, "While these changes may be upsetting, they are not medically dangerous. Talk with your health care provider if you experience side effects for more than 3 months. You may want to change the kind of pill you are taking." This educational point was not listed on the verbal Education Practice Standards, which may have contributed to the lower frequency (60% compared to all others having 84 % to 90 % recall) of recall of this point. This point is important because common side effects often occur during the first three cycles of use and then usually disappear. If the side effects do not resolve, a change in oe preparation may be required to control specific side effects. Emphasizing the temporary nature of these side effects and the need not to discontinue the oes as a result of them without informing the provider are important. This information gives the provider the opportunity to reassess side 52 effect severity and to emphasize the transient character of the symptoms. On average, the women rated their education about issues other than side effects as being quite important (range of 1.82 to 3.56, with an overall mean of 2.56) in terms of helping them to decide to be compliant with oes. The most important educational point in this sample was the effectiveness of oes. The need for a yearly follow-up physical examination was the second most important educational point indicated by the sample, and it was also one of the most remembered educational points. The noncontraceptive benefit of oes was rated the third highest in inlportance. This point was recommended for inclusion in oe initiation education in previous research reports (Rosenberg et al., 1995; Serfaty, 1992). Possible Explanations The association of unexpected side effects with increased perceived severity names the question, "Why were some of the side effects expected whereas others were unexpected?" As stated in this thesis under "theoretical framework," it was shown that women form their initial representation of somatic symptoms based upon previous information received from their environment (Herold & Goodwin, 1980; Keller et al., 1989). The provider has an opportunity at the time of oe initiation to influence this representation based upon the education that the provider gives. Most of the side effects on the questionnaire of this study were mentioned on the written brochure given to the woman at the time of De initiation. 53 However, these side effects were still rated as unexpected by as many as 45 % of the subjects. Even though none of the research questions of this study examined the difference between written and verbal information, an additional investigation was made as an outcome of the results that suggested that this may be an important determination. In a review of the literature on the subject of written patient information, Arthur (1995) concluded that written data increased patient knowledge of medications but that the addition of verbal reinforcement produced more significant increases in patient knowledge. Arthur asserted in his review of the literature that it cannot be assumed that because written information is given that the patient will read it and be educated. Data from this study support Arthur's suggestions. For example, all of the points on the verbal Education Practice Standards had a high recall rate (84% to 97%), whereas, in comparison, the only point that was not on the verbal protocol but was in the printed brochure had a 60% recall rate only. In addition, the side effects that were not included on the verbal protocol or the printed brochure were those expected by most subjects. In fact, the side effects included in the printed brochure only were rated as unexpected by as many as 45 % of the subjects. The extent to which information from sources other than Planned Parenthood Association of Utah was used by subjects is not known. Arthur (1995) also said that written information did not improve compliance when added to verbal information only, suggesting that the verbal education is the significant part in affecting compliance behaviors. In addition, the data from this 54 study support Arthur's conclusions, showing that the most frequent DC discontinuations were due to side effects that were presented on the printed brochure only. The majority of side effects was presented on the printed brochure, whereas there were only 5 (out of 18) side effects listed on the verbal Education Practice Standards. This fact most likely contributes to the low recall rate of discussion with the provider; that is, a range of 56% to 83% of the side effects were rated as not discussed with the provider). The extent to which individual providers gave information not listed on the verbal education practice standards is not known. However, without discussion of the side effects, the provider loses the opportunity to assess the woman's representation, as well as the chance to educate her appropriately, thus influencing her representation. Therefore, the potential for unexpected side effects occurs, which has been shown to cause more frequent discontinuations. Despite this potential for unexpected side effects as a result of low discussion of them with the provider, this study showed that the majority of the side effects was found to be expected. This finding may support the argument that the women must have relied upon the printed brochure in order to create an accurate representation. However, as presented earlier in this chapter, the data support the women who did not rely on this information on the basis of the unexpected side effects fronl the printed brochure and the low recall of education not on the verbal protocol compared to the printed protocol. The possibility is that the women simply may not recall information from providers even though the information influenced their representation. An explanation that is more likely based on the results of this study is that the women relied on information from other sources outside the clinic prior to initiating OCs. 55 In summary, as Arthur (1995) found in his review, written information is more effective when reinforced with verbal education. The written information given by Planned Parenthood is extensive, and it mentions the majority of common side effects. However, the verbal education provided regarding side effects specifies only five side effects. This low number of side effects listed on the verbal education may explain the overall low rates of recall of discussion of side effects with the provider. In addition, the education provided verbally had an extremely high recall rate, suggesting the importance of this method. The printed information that was not reinforced verbally was most likely not very important in the representation formation, suggesting that the women relied upon information from other sources. Most of the time, this information created an accurate schema, contributing to the high rate of expected side effects. However, when a side effect occurred that did not match the woman's representation and that was not discussed with the provider, it was perceived as moderately severe, leading to the most discontinuation. The cause for these discontinuations is important to examine further. In previous research, it was recommended that a 3-month follow-up should be made succeeding OC initiation in order to assess the woman's compliance and experience with OCs (Hillard, 1992; Rosenberg et al., 1995; Serfaty, 1992; Weisberg, 1995). 56 At this time, the provider would have the opportunity to discuss any side effects that the woman may have experienced or continues to experience, answer any questions or misconceptions, and switch to another OC preparation if needed. This approach is suggested to increase compliance. However, no relationship was found between women who had a follow-up appointment and those who did not in terms of side effect severity scores, even though the retrospective nature of the study is a limitation in interpreting these data. Because no educational protocol exists for the follow-up visit and the woman does not necessarily see the provider, discussion of side effects cannot be assumed to occur at the time of follow-up. Without discussion of the side effect at initiation or at the follow-up, there is no opportunity to influence representation, and women experiencing unexpected side effects may discontinue OCs. This decision could be viewed as a coping response based upon the woman's initial representation of OC side effects. The interaction between the subject's side effect severity and perceived educational inlportance also was examined in Research Questions 4 and 5. A significant relationship was found between increased side effect severity and decreased perception of educational importance. This finding also can be explained by the above interpretation. When a woman experienced an unexpected side effect, she perceived it to be more severe and was more likely to discontinue her OCs because of the symptom. This finding may be the result of a lack of anticipatory guidance given verbally at the time of OC initiation by the provider. The experience of side effects not discussed by the provider may cause women to 57 lose trust in the provider and to view the education received as unimportant. This suggestion also is supported by the findings that showed women who discontinued Des viewed the education as less important than continuers and remembered less of the education program content. Implications for Nursine The explanation provided in the previous section creates important nursing implications. Clinical Practice In terms of implications for clinical practice with emphasis on the role of the family nurse practitioner, the results suggest that side effect education for De initiation needs to be extensive, specific, and given verbally. This finding needs to be given at the time of initiation of Des in order to influence the patient's representation of side effects expected to limit discontinuation of Des. In order to avoid overwhelming patients with irrelevant or vague information, side effects discussed should be those that occur most frequently, with the temporary and benign nature of the side effects emphasized. The need not to stop the Des during the first three cycles without informing the provider should be emphasized. The theory of Leventhal et al. (1980) supports this implication; that is, concrete information leads to formation of an accurate schema or representation. Thus, when somatic symptoms occur that match this schema, confidence in the provider is established, along with a solidification of the accurate representation. 58 At the follow-up visit, the provider has an opportunity to reassess the patient's representation. In the event that an unexpected side effect is experienced, it can be discussed, allowing the provider to redirect the representation in order to prevent noncompliance or change the OC preparation. With implementation of a follow-up educational practice standard that again addresses all potential side effects, an opportunity will be given to the provider to influence the original representation. Then coping and appraisal behaviors will be based upon an appropriate representation. Additional points should be included as part of OC initiation information such as emphasis on the high efficacy of OCs compared to other methods of contraception, need for yearly physical examination, and noncontraceptive benefits of OCs. These recommendations are based upon what the subjects perceived to be important in their decision to comply with OCs. Education The education of nurses and medical personnel often deals primarily with understanding the physiology behind symptoms. Results of this study indicate the need for providers to assess patients' perceptions of these symptoms in order to facilitate appropriate representation and compliance. The education that the nurses and providers receive should include tools that will assist them in their assessment and understanding of these perceptions and behavioral responses such as the theory of self-regulation (Leventhal et al., 1980). Future Research Future studies should focus on prospective tests of the effect of accurate representation and compliance, the influence on information obtained from other sources of representation, and the role of a structured 3-month follow-up in enhancing compliance. The extent to which a side effect is initially viewed as unexpected can be reappraised as expected and normal, and it also can require additional research. Examination on promoting compliance also is needed. 59 Based on the results and discussion, recommendations are made for future studies. First, OC type should be included in order to account for extraneous variables that may influence conclusions. Second, sampling should be made from different populations in order to describe various practice setting findings and to create additional generalizable results. Utilizing unlicensed assistant personnel to provide education may produce a pattern of results different from that obtained when primary care providers provide the education. Differences in content and process need to be examined; therefore, further research is needed. As stated at the beginning of this chapter, this study was not intended to generalize beyond the practice setting. The results came from a very narrow population, which is not representative of women seeking OCs. However, the study provided important suggestions for future research and specific implications for practice in the setting. 60 Summary Statement Despite the limitations of this retrospective study, important information was provided. The side effects recalled in the sample were moderate in severity. Side effect severity was higher if the side effect was unexpected rather than expected, even though most side effects were expected. Unexpected severe side effects led to discontinuation of oes. Recall of discussion of individual side effects with the provider was low in the sample, which is consistent with the fact that only five of the side effects are named on the verbal Planned Parenthood Federation of America education protocols. Results showed that printed information may not have influenced side effect representation. Discussion of the side effect(s) with the provider was not associated with the side effect(s) severity scores. The education documented to have been taught by the providers verbally had a high recall rate and was scored relatively high in importance by the subjects. Educational importance scores were even higher if the subject continued to take oes compared to subjects who had discontinued. Educational points important to the women's decision to continue to take OCs included OC efficacy, noncontraceptive benefits of oes, and need for yearly physical examination. Implications for nursing from this study include the suggestion that expanding the verbal side effect education to address specific OC side effects likely to occur in the first three cycles is important to subsequent compliance. The 3- month follow-up appointment should be mandated so that side effects can be appropriately managed and education regarding the nature of the side effects can be 61 explained. A structured follow-up educational program for this visit may improve patient knowledge and compliance. Education of nurses should focus on emphasizing the need to assess patients' perceptions of somatic symptoms allowing appropriate education to be given. Future prospective research studies are needed in order to evaluate the suggestions of this study. The problem of compliance issues related to oe use continues to be a large aspect of nursing and primary care. Many suggestions have been made from research that practitioners can apply to practice in order to limit noncompliance. Because of the chronic nature of oes and the complex issues of contraceptive management, providers must always consider women's perceptions of these issues. Noncompliance with oes continues to create a need for future research to determine additional solutions to this problem. oes represent a potentially well­tolerated, highly efficacious, and safe method of birth control available to women. Therefore, health care providers have the obligation to identify barriers that prevent some women from perceiving oes to be appropriate for them. Through education and support, providers have an opportunity to influence patient knowledge and compliance and should, therefore, take full advantage of this opportunity to make a difference. APPENDIX A RELATION OF COMMON SIDE EFFECTS TO HORMONE CONTENT Breast cystic changes Cervical exstrophy Dysmenorrhea H ypermenorrhea Increase in breast size Mucorrhea Uterine enlargement Chloasma Chronic nasal pharyngitis Gastric influenza and varicella Hay fever and allergic rhinitis Urinary tract infection Capillary fragility Cerebrovascular accident Deep vein thrombosis Telangiectasias Thromboembolic disease Proeestin Excess Cervicitis Flow length decrease Moniliasis Appetite increase Depression Fatigue H ypogl ycemia Libido decrease Neurodermatitis Weight gain (noncyclic) Hypertension Leg vein dilation Androeen Excess (related to proeestin) Hirsutism Libido increase Oil y skin and scalp Rash and pruritus Weight gain (noncyclic) Cholestatic jaundice Acne 63 Estroeen Deficiency Absence of withdrawal bleeding Bleeding and spotting (days 1 to 9) Continuous bleeding and spotting Hypomenorrhea Pelvic relaxation symptoms Vaginitis atrophic Nervousness Vasomotor symptoms Pro2estin Deficiency Breakthrough bleeding and spotting (days 10 to 21) Delayed withdrawal bleeding Dysmenorrhea Heavy flow and clots Estroeen Excess or Proeesterone Deficiency Bloating Nausea, vomiting Visual changes Weight gain (cyclic) Dizziness, syncope Edema Headache Irri tabil i ty Leg cramps 64 Note. From Managing Contraceptive Pill Patients (8th ed.) (pp. 148-149) by R. P. Dickey, 1995, Durant, OK: Essential Medical Information Systems, Inc. Copyright 1995 by Essential Medical Information Systems, Inc. Reprinted by permission. APPENDIX B PLANNED PARENTHOOD ORAL CONTRACEPTIVE INITIATION EDUCATION PROTOCOL Date: Patient #: Name of patient: Date of birth: Telephone #: Planned Parenthood Association of Utah Sample Method Specific Request for Examination, Treatment. and Provision of Oral Contraceptives (Birth Control Pills) 66 Before you give your consent, be sure you understand both the pros and cons of using the Pill. This form lists the possible complications that can occur with the Pill and the danger signs you should watch for. If you have any questions as you read, we will be happy to discuss them. You can change your mind at any time about using the Pill. Remember that your consent is entirely voluntary. You may ask for a copy of this form. Instructions to patient: Place your initials after each statement to indicate that you have read, understand, and agree with the statement. I have received from Planned Parenthood a brochure containing information on the use, effectiveness, and medically recognized benefits and risks of the available birth control methods and devices. I have read the brochure, understand it, and have had all my questions answered. __ I understand that I will receive the FDA-approved written information pamphlet provided by the Pill manufacturer. I know that I should read it and ask questions about anything I do not understand. __ The Pill provides highly effective pregnancy protection, especial I y if I take the Pill correctly. __ I understand that, in addition to its value as a method of birth control, most women experience the following benefits from using the Pill: decreased menstrual cramps and blood loss; predictable, regular menstrual cycles; less iron deficiency anemia; less acne; some protection from noncancerous breast tumors and ovarian cysts; some protection from ovarian and uterine lining cancer; decreased risk of infection of the pelvis (P.l.D.); and fewer ectopic pregnancies. __ 67 I understand that there may be less protection from pregnancy when the Pill is taken with certain drugs, especially those used to control seizures. I understand that I should talk to my clinician about what to do if I take any other medicine with the Pill. I understand that if I see another health care provider for any reason I should tell him/her that I am on the Pill. I understand that I should not take the Pill if I have reason to believe that I might be pregnant. __ I understand that Pill users have a slightly greater chance than nonusers of developing certain serious problems that may become fatal in rare cases, including blood clots in the legs that can travel to the lungs, stroke, heart attack, and liver tumors. I understand that the chances of developing serious health problems increase with age over 35 years old and when certain other health risk factors are present such as smoking more than 15 cigarettes a day, high blood pressure, high levels of blood cholesterol or fat, and diabetes. __ I understand that I should not use the Pill if I have had, nor have, or develop in the future blood clots in the veins or arteries; serious liver disease; a heart attack or certain types of stroke; and cancer of the breast, uterus, or liver. __ I understand that I may need special tests if I have certain medical conditions that could get worse while using the Pill. __ I understand that some minor reactions to the Pill may include nausea/vomiting, breast tenderness, weight gain or loss, and spotting between periods. __ I know to watch for the following Pill danger signals and to report any to a clinician immediately: sharp or crushing chest pain or coughing blood; shortness of breath, unusual swelling or pain in the legs or arms, sudden severe headaches; eye problems such as blurred or double vision or loss of vision; severe pain in the stomach or abdomen; yellowing of the skin or eyes; severe depression; unusually heavy bleeding from the vagina; new lump in my breast; and no period after having a period every month. __ I understand that the risk to life and health is greater from pregnancy than from Pill use, except when a woman is age 35 or older and smokes heavily or who has certain other medical conditions. I understand that using the Pill does not protect against sexually transmitted infections and that a bad infection could cause sterility. I understand that if I or my partner have other sexual partners I also should use latex condoms to prevent infections, even though I am using the Pill. __ 68 I will be given referrals for further diagnosis or treatment if necessary. I understand that if referral is needed, I will assume responsibility for obtaining and paying for this care. I have been told how to get care in case of a medical emergency. __ No guarantee has been made to me as to the results that may be obtained if I use oral contraceptives or any other method of birth control. I understand that regular checkups are necessary while taking the Pill, and I know when to return for follow-up care. __ I understand that if tests taken for sexually transmitted infections are positive, reporting of certain positive results to public health agencies is required by law. I hereby request that a person authorized by Planned Parenthood examines and treats me and that birth control pills will be provided to me. __ I hereby give my permission to the employees of Planned Parenthood of Utah and others authorized by them to use information contained in my medical record for statistical purposes with the understanding that my confidentiality will be maintained. Signature of patient: Date: I witness the fact that the patient received the above information and said she read and understood same. Signature of witness: Date: Note. From Planned Parenthood for a Responsible Choice for a Better Life by Planned Parenthood Association of Utah, 1996, Salt Lake City: Author. APPENDIX C CRITERIA OUTLINE PLEASE INDICATE BELOW "YES" IF THE PATIENT MEETS THE CRITERIA OR "NO" IF THE PATIENT DOES NOT MEET THE CRITERIA TO THE BEST OF YOUR KNOWLEDGE: • FEMALE • BETWEEN AGES 18 AND 45 70 • STARTED ON ORAL CONTRACEPTIVES FOR THE FIRST TIME AT PLANNED PARENTHOOD WITHIN THE LAST 2 YEARS BUT DOES NOT NEED TO CONTINUE TAKING ORAL CONTRACEPTIVES. • WAS NOT INSTRUCTED TO STOP TAKING ORAL CONTRACEPTIVES FOR MEDICAL REASONS. YES: NO: THANK YOU SO MUCH! APPENDIX D COVER LETTER FOR PARTICIPATION IN AN INVESTIGATIONAL STUDY 72 You are invited to participate in a research study entitled "Women's Recollections Regarding the Initiation of Oral Contraceptives, Including Side Effects, Education, and Compliance: A Descriptive Study." The purpose of this stud Y is to determine what you and other women remember about starting birth control pills, including what side effects you experienced, what education you remember receiving, and how much education and side effects influence your decision to continue taking the pills. No studies have been conducted that ask women what they believe to be important in helping to decide whether to continue taking birth control pills. If you choose to be in this study, you will be asked to fill out a three-part questionnaire while in the clinic and then return it to the investigator or mail it back in the self-addressed, stamped envelope given to you. The questions will relate only to your experiences with taking the pill and the education and follow-up you received from Planned Parenthood. There are no known risks to you in this study. There are no costs to you other than the time it takes to fill out the questionnaire. There are no direct benefits to you if you participate in this study, but you will be contributing to a better understanding of what helps women to continue taking birth control pills and how better care and support can be provided to women starting the pill. In the event you sustain physical inj ury resulting from your participation in the research project, the University of Utah can provide to you, without charge, emergency and temporary medical treatment not otherwise covered by your own insurance. If you believe that you have sustained an injury as a result of your participation in this research program, please contact the Office of the Vice President for Research at [phone]. If you choose to participate in this study, your questionnaire is completely anonymous; this means that you do not include your name. No one will know who you are, not even the researcher. All written materials will be locked in a box at the investigator's home. Your participation is voluntary, and you may choose not to participate if you wish. If you choose not to fill out the questionnaire, your decision will not influence the care you receive at Planned Parenthood. If you have any questions about this study at any time, you may contact Cindy Butters (the investigator in charge) at [phone], 24 hours a day. If you have questions regarding your rights as a research subject or if problems arise that you do not believe you can discuss with the investigator, please contact the Institutional Review Board at [phone]. By completing and returning the questionnaire, your consent for participation in the study will be implied. Please keep this copy of the cover letter for your records. APPENDIX E QUESTIONNAIRE PART ONE: Demoeraphic Information CODE Insturctions: Please circle the most appropriate category for you. Age: 18-22 23-27 28-32 33-37 38-45 None listed Marital status: Married Single Divorced Separated Live with partner Race: Anglo Hispanic African Asian! Native Other American American American Pacific Islander American American Religion: Catholic Latter Day Jewish Protestant None Other Saint Education: Less than high High school Some college Two year Bachelor's Graduate school graduate college degree degree or higher History: Please answer the following questions to the best of your knowledge. U any questions do not apply to you, answer with "N/A." Uyou don't remember, check "don't remember." I.How long ago did you start taking the pill for the first time? 2.How many months did you take the pill without stopping? 3.How long ago did you stop taking the pill? 4.Did you return to the clinic for a 3-month follow up after starting the pill? (please circle) YES NO 5.What was the reason that you stopped taking the pill? 6.Did you take any other prescription medication for more than 2 weeks while on the pill? (please circle) YES NO if yes, what were they? ___________________ _ lliuLt Remember: o o o o o o 74 PART TWO: Side Effects A. Please check the box under "don't remember" if you do not remember whether or not you had that particular side effect, leave it unchecked if you do remember, and complete the rest of the line for tbat side effect. B. Please circle tbe number on a scale from 0 (did not have) to 4 (extremely severe) according to how severe you had that side effect. ~ o=- Did not have 1 =Remember to be slil:htly bothersome 2= Remember to be moderately severe 3= Remember to be Quite severe 4= Remember to be extremely severe C. In tbe next column, please circle "Y" for yes if you discussed tbat side effect with your provider or "N" for no if you did not. D. In the next column, please circle "Y" for yes if that side effect was unexpected or "N" for no if you did expect that side effect. E. Finally, please circle "Y" for yes if that side effect caused you to stop taking birth control pills or "N" for no if it did not lead you to stop. ~ C: Di~cg~~~d 11: l!neIR~ct~d E;: Caus~d [~memtu~r II: S~verio: witb Rr!2vider7 ~ide ~ffect? t2 ~t!2R takinafl SIDE EFFECIS Breast changes 0 0 2 3 4 Y N Y N Y N Menstrual irregularities 0 0 2 3 4 Y N Y N Y N Menstrual cramps 0 0 2 3 4 Y N Y N Y N Change in appetite 0 0 2 3 4 Y N Y N Y N Weight gain 0 0 2 3 4 Y N Y N Y N Fatigue 0 0 2 3 4 Y N Y N Y N Decrease in sex drive 0 0 2 3 4 Y N Y N Y N Increase in sex drive 0 0 2 3 4 Y N Y N Y N Oily skin and scalp 0 0 2 3 4 Y N Y N Y N Acne 0 0 2 3 4 Y N Y N Y N Bloating 0 0 2 3 4 Y N Y N Y N Nausea 0 0 2 3 4 Y N Y N Y N Vomiting 0 0 2 3 4 Y N Y N Y N Headache 0 0 2 3 4 Y N Y N Y N Mood changes 0 0 2 3 4 Y N Y N Y N F actal hair growth 0 0 2 3 4 Y N Y N Y N Facial skin darkening 0 0 2 3 4 Y N Y N Y N V isual changes 0 0 2 3 4 Y N Y N Y N Any other side effect not listed (please list) 0 2 3 4 Y N Y N Y N 75 PART THREE: Education 1. With the following educational points, try to remember when you were taught about these by your provider. If you do not remember ever being taught about that point(s), check the first box under "don't remember. n 2. If you do remember discussing that point with your provider, please complete the rest of the line by circling the number on a scale from 0 (not important) to 4 (extremely important) according to the level of importance that educational point was to you in makine your decision to continue takine birth control pills. ~ O=Not at all important to me in my decision to take 1 = Sli\ihtly important to me in my decision to take 2= Moderately imJ>ortant to me in my decision to take 3= Ouite important to me in my decision to take 4= Extremely important to me in my decision to take Don't [~memb~[: EDUCA TIONAL POINT: Benefits of using birth control pills (BCPs) 0 Risks of using BCPs 0 Effectiveness of BCPs 0 Use of BCPs does not protect you from some sexually transmined diseases 0 Instructions regarding how to talce B.Ps 0 Interaction between smoking and taking BCPs 0 Do not take BCPs if you think you may be pregnant 0 Not to stop taking BCPs during the frrst 3 months unless notify health care provider 0 Danger signs of severe side effects from BCPs 0 Need for follow-up yearly for physical exam 0 Interaction of BCPs with other medications 0 Any other points that you remember being taught by your provider: THE END. THANK YOU SO MUCH 0 0 0 0 0 0 0 0 0 0 0 o o L~vd 2( imI!2[t!lm;~ FOR 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 YOUR 4 4 4 4 4 4 4 4 4 4 4 4 4 TIME!!! 76 APPENDIX F PLANNED PARENTHOOD FEDERATION ASSOCIATION BROCHURE ON ORAL CONTRACEYfIVES All About THE BIRTH CONTROL Pill What is the birth control pill? Birth control pills contain estrogen and progestin, hormones which are similar to hormones normally produced by a woman's body. The pills prevent pregnancy by stopping the release of eggs from a woman's ovaries, and by thickening a woman's cervical mucus. How effective is the pill? Of 100 women taking the birth control pill for a year, 3 may be­come pregnant.Women who take the Pill correctly every day have less than a one percent chance of getting pregnant. The pill may be less effective when combined with certain antibiotics or antiseizure medication. What do some women like about the pill? Many women find that the pill is a safe, convenient, and effective way to prevent pregnancy. A woman's periods may also become more regular, with less cramping and blood loss, when she is using the birth control pill. The pill has some medical advan­tages for many women. These include less iron deficiency anemia, less acne, less pelvic inflammatory disease, and fewer ectopic pregnan­cies. The pill may also protect against non-cancerous breast tu­mors, ovarian cysts, and ovarian and endometrial cancer. What about side effects? It may take three month or so for a woman's body to adjust to the birth control pill. During this lime, she may experience some side effects. Minor side effects may include: Nausea and vomiting A slight change in weight Breast tenderness or enlarge­ment Some bleeding or spotting between periods Headaches that go away with aspirin or rest Fluid retention or "bloating" Skin changes including acne or spots of darker skin on the face (may be permanent) Mood changes or feeling tired While these changes may be upset­ting, they are not medically danger­ous. Talk with your health care provider if you experience side effects for more than three months. You may want to change the kind of pill you are taking. Are there any serious health problems from the pill? Most women who use the combined pill have no permanent or serious changes in their health. However, women who smoke more than 15 cigarettes a day, who are over the age of 35, or who have certain medical problems should talk with a clinincan. 78 Serious pill complications: High blood pressure (hyperten­sion) • Gall bladder disease Blood clots in the legs, lungs, eyes, brain, or elsewhere • Heart attacks and strokes liver tumors or jaundice Tell your doctor that you are taking the pill, especially if you are planning to have surgery or need to spend time in bed. You may be asked to stop taking the pill during this time to reduce the risk of blood clots. Danger signs, tell your clinician immediately if you have: Sharp or crushing chest pain or coughing blood • Shortness of breath Unusual swelling or pain in the legs or arms • Sudden severe headaches • Eye problems such as blurry or double vision or loss of vision Severe pain in abdomen or stomach • Yellowing of the skin or eyes Severe depression What about smoking? Smoking is associated with cancers of the lung, breast, mouth, throat, pancreas and bladder. Smokers also have more heart disease. Smoking combined with birth control pills work together to in­crease a woman's risk of heart attack, stroke and blood clots. The older the woman and the more she smokes, the greater the danger. What about cancer? The birth control pill protects a woman from endometrial and ovarian cancer, but we do not yet know if the pill influences breast cancer. What if I want to have a baby later? The birth control pill does not cause permanent changes in a woman's ability to get pregnant, although it may take a few months longer. The pill does not cause infertility, al­though exposure to sexually trans­mitted diseases may. Remember to use condoms to protect yourself from sexually transmitted diseases. How do I start taking the pilB Start your first packet of pills on the first Sunday after your period begins or the first day of your period. Use a back up method of birth control for the first seven days. If your pack has 28 pills, start a new package the very next day after finishing the last pill in a pack. TAKE A PILL EVERY DAY, EVEN IF YOU DO NOT HAVE BLEEDING BETWEEN PACKETS OF PILLS. Take a pill at the same time every day. If you feel nauseous, take your pill at bedtime or with a meal. What if I miss a pill? If you miss 1 pill: Take 1 now, the next at the usual time. If you miss 2 pills in a row in the first 2 weeks: Take 2 for 2 days, and also use backup birth control for the next 7 days. If you miss 2 or more pills in a row in the third week,or you miss 3 or more pills in a row anytime: If you always start on Sundays: Keep taking pills until the next Sunday. Throw out the rest of the pill pack. Start a new pack that Sunday and use backup birth control for the next 7 days. You may not have a period this month. If you do not start on Sundays (day 1 starters): Throw out the rest of the pill pack. Start the next pack that day. Also use backup birth control for the next 7 days. You may not have a period this month. 28-day pill pack: If you forget any of the 7 "reminder" pills (no hormones), throw out the pills you missed and keep taking one each day until the pack is empty. You do not need a backup method. If you have any questions, please call your clinic. What If I skip a period? Don't worry if you skip a period as long as you have not missed a pill. Some women using the birth control pill miss periods every once in a while. Although it is unlikely that you are pregnant, you can always call the clinic if you have questions. Continue taking your pills on time. If you have skipped two periods, come to the clinic for a pregnancy test. If you forgot to take a pill on time, and have missed a period, you may be pregnant. Come to the clinic for a pregnancy test as soon as you have missed a period. What if I want to stop using the pilB When you decide to stop using the pill, wait until you have finished taking a whole pack of pills. You may not have a period right away after stopping the pills. If you miss more than one period, come in for a pregnancy test. 79 If you want to get pregnant, plan on using another birth control method until you have had two or three normal menstrual periods. For more information, read the FDA approved information pamphlet provided by the manufacturer. If you have a medical emergency, contact your Planned Parenthood clinic immediately. If you can not reach your clinic, go the nearest emergency room or to your private doctor. logan Clock Tower Plaza 550 North Main #117 753-0724 Ogden 4387 Harrison Blvd. 479-7721 Park City 1670 Bonanza Drive 649-5989 Salt lake City 654 South 900 East 322-5571 Utah Valley 1840 S. Columbia Lane, Orem 226-5246 West Valley 2107 West 3500 South 973-9675 Teen Center 2109 West 3500 South 973-9675, ask for the Teen Center Outside these areas: 1-800-627-9558 State Administration & Education 654 South 900 East, Salt Lake 532-1586 http://www.xmission.com/-ppau Public Affairs Hotline: 238-AlRT or 1-800-830-AlRT CJ ~!:~I~~~ta~arenthood· A Responsible Choice for a Healthier Ufe. 11/96 ~ From Planned Parenthood for a Responsible Choice for a Better Life by Planned Parenthood Association of Utah, 1996, Salt Lake City: Author. REFERENCES 81 Arthur, V. A. (1995, June). Written patient information: A review of the literature. Journal of Advanced Nursing, pp. 130-134. Balassone, M. L. (1989). Risk of contraceptive discontinuation among adolescents. Journal of Adolescent Health Care. 10. 527-533. Baumann, L. J., Cameron, L. D., Zimmermann, R. S., & Leventhal, H. (1989). Illness representations and matching labels with symptoms. Health Psychology, 8(4), 449-469. Cameron, L., Leventhal, E. A., & Leventhal, H. (1993). Symptom representations and affect as determinants of care-seeking in a community­dwelling, adult sample population. Health Psychology, 12(3), 171-179. Dickey, R. P. (1995). Managing contraceptive pill patients (8th ed.). Durant, OK: Essential Medical Information Systems, Inc. Edgren, R. (1991). Oral contraception: A review. Internal Journal of Fertility, 36(Suppl. 3), 16-25. Gilbert, J. R., Evans, C. E., Haynes, R. B., & Tugwell, P. (1980). Predicting compliance with a regimen of digoxin therapy in family practice. Canadian Medical Association Journal, 123, 119-122. Hatcher, R., Trussell, J., Stewart, F., Stewart, G. K., Kowal, D., Guest, F., Cates, W., & Policar, M. S. (1994). Contraceptive technology (16th rev. ed.). New York: Irvington Publishers, Inc. Herold, E. S., & Goodwin, M. S. (1980). Perceived side effects of oral contraceptives among adolescent girls. Canadian Medical Association Journal, 123. 1022-1026. Hillard, P. J. A. (1989). The patient's reaction to side effects of oral contraceptives. American Journal of Obstetrics and Gynecology, 161. 1412-1415. Hillard, P. J. A. (1992). Oral contraception noncompliance: The extent of the problem. Advances in Contraception. 8CSuppl. 1), 13-20. Kaunitz, A. M. (1993). Combined oral contraception with desogestrel/ethinyl estradiol: Tolerability profile. American Journal of Obstetrics and Gynecology. 168(3,2), 1028-1033. Keller, M. L., Ward, S., & Baumann, L. J. (1989). Processes of self­care: Monitoring sensations and symptoms. Advances in Nursing Science. 12(1), 54-66. Lemke, D. P., Pattison, J., Marshall, L. A., & Cowley, D. S. (1995). Primary care of women. East Norwalk, CT: Appleton & Lange. Leventhal, H., Meyer, D., & Nerenz, D. (1980). The common sense representation of illness danger. In S. Rachman (Ed.), Medical psychology (Vol. 2, pp. 7-30). New York: Pergamon Press. 82 McLaurin, V. L., & Dunson, T. R. (1991). A comparative study of 25 mcg and 50 mcg combined oral contraceptives: Results from a multicenter clinical trial. Contraception, 44(5), 489-503. Morris, L. A., Mazis, M., & Gordon, E. (1977). A survey of the effects of oral contraceptive patient information. Journal of the American Medical Association. 238(23), 2504-2508. Neel, E. U., Litt, 1. F., & Jay, S. S. (1987). Side effects and compliance with low and conventional dose oral contraceptives among adolescents. Journal of Adolescent Health Care, 8, 327-329. Oakley, D., Sereika, S., & Bogue, E. (1991). Oral con tracepti ve pill use after an initial visit to a family planning clinic. Family Planning Perspectives, 23(4), 150-154. Planned Parenthood Association of Utah. (1996). Planned parenthood for a responsible choice for a better life. Salt Lake City: Author. Polit, D., & Hungler, B. (1995). Nursing research principles and methods (5th ed.). Philadelphia: J. P. Lippincott. Pratt, W. F., & Bachrach, C. A. (1987). What do women use when they stop using the pill? Family Planning Perspectives, 19(6), 257-266. Rosenberg, M. J., Burnhill, M. S., Waugh, M. S., Grimes, D. A., & Hillard, P. J. A. (1995). Compliance and oral contraceptives: A review. Contraception. 52, 137-141. Rosenberg, M. J., & Long, S. C. (1992). Oral contraceptives and cycle control: A critical review of the literature. Advances in Contraception, 8(Suppl. 1), 35-45. 83 Rosenberg, M. J., Waugh, M. S., & Long, S. (1995). Unintended pregnancies and use, nlisuse, and discontinuation of oral contraceptives. Journal of Reproductive Medicine. 40(5), 355-360. Rosenfeld, L. A., Zahorik, P. M., Saint, W., & Murphy, G. (1993). Women's satisfaction with birth control. The Journal of Family Practice. 36(2), 169-173. Serfaty, D. (1992). Medical aspects of oral contraceptive discontinuation. Advances in Contraception, 8(Suppl. 1), 21-33. Ward, S. E. (1993). The common sense model: An organizing framework for knowledge development in nursing. Scholarly Inquiry for Nursing Practice: An International Journal. 7(2), 79-90. Weisberg, E. (1995). Prescribing oral contraceptives. Drugs. 49(2), 224- 231. Woods, E. R., Grace, E., Havens, K. K., Merola, J. L., & Emans, S. J. (1992). Contraceptive compliance with a levonorgestrel triphasic and a norethindrone monophasic oral contraceptives in adolescent patients. American Journal of Obstetrics and Gynecology, 166(3), 901-907.