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November 21, 2009
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James Trussell's Research Health and WellbeingJames Trussell and Kelly Cleland continue their collaborative work with the Association of Reproductive Health Professionals (ARHP) on increasing public awareness of and access to emergency contraception. ARHP and the Office of Population Research sponsor the Emergency Contraception Hotline (1-888-NOT-2-LATE) and the Emergency Contraception Website (not-2-late.com). The Hotline provides detailed information about emergency contraception, as well as the phone numbers of five nearby clinicians who will provide emergency contraceptives in the United States. The Website contains more detailed information and the complete listing of providers. The Hotline is available in English and in Spanish. The website is available in English, Spanish, French, and Arabic. Since it was launched on February 14, 1996, the Hotline has received more than 700,000 calls. The Website has received more than five million visitors since it was launched in October 1994; there are currently about 125,000 visitors per month. The Website was completely redesigned and re-launched in September 2006.
With colleagues from the University of Rochester, Lisa Wynn (Macquarie University), Kelly Cleland, and James Trussell conducted a study of 200 women in New York State seeking ECP prescriptions through the internet. Eight in ten Internet users have sought health information online, and web-based medical resources are growing in number. Yet little is known about women who seek ECPs from the Internet. Using a mixed methods approach, with surveys and qualitative interviews conducted by telephone, this study collected descriptive data on women seeking ECPs via the Internet, identified barriers to ECP access, and assessed attitudes towards advance provision and nonprescription ECPs. Participants were predominately white, college-educated, and urban residents. Most women sought ECPs through the Internet without first seeking prescriptions from local providers, anticipating structural and attitudinal barriers to obtaining ECPs from local providers. While women supported advance prescription of ECPs, there was less enthusiasm for nonprescription ECPs due to concerns that others (but not themselves) would engage in risky sexual behavior. Yet even in this group of women seeking drug prescriptions through unconventional means, many women still stated that they valued the consultation with a health professional and would still prefer to speak with a clinician even if nonprescription ECPs were available. This study showed that there is a need to address beliefs that increased ECP availability promotes risky sexual behavior, as current evidence refutes this concern.
In a paper prepared for an IUSSP workshop on ethics and reproductive health and later published in Studies in Family Planning, Lisa Wynn, James Trussell, Angel Foster (Ibis Reproductive Health), and Joanna Erdman (University of Toronto Law School) comparatively examine the debates over non-prescription access to emergency contraceptive pills in the United States and Canada. In April 2005, Health Canada reclassified the emergency contraceptive pill (ECP) Plan B as a non-prescription drug. Upon reclassification, provincial pharmacy regulators restricted the sale of Plan B to behind-the-counter status, thereby requiring pharmacist assessment and counseling at the point of sale. A coalition of national organizations in Canada is petitioning to have the status of ECPs moved off-schedule, i.e. sold without pharmacist intervention. These groups object to the way that some pharmacists require women seeking ECPs to provide information about their sexual history in order to receive the product. This research project compares arguments employed by proponents of expanded ECP access in Canada and the United States to challenge the prescription status of the medication. In Canada, the dominant argument asserted women's rights to equitable and effective access to health care services. In the United States, proponents of expanded ECP access asserted the drug's safety and ability to reduce public health problems. This research project uses critical discourse analysis to deconstruct the key texts and position statements in favor of expanded ECP access in both countries and reveal the implicit underlying assumptions about sexuality, the role of the state and medical authorities in the sexual lives of men and women, and the rights and abilities of individual women to make informed decisions regarding their sexuality and reproductive health. A harm reduction model predominated in the health arguments marshaled in support of expanding ECP access. In this view, sex leads to various problems, from the transmission of sexually transmitted infections to unintended pregnancy, pregnancy-related morbidity, and abortion. Expanding access to ECPs reactively contains some of these public health problems. A competing framework arguing in favor of expanded EC access was also evident, particularly in the Canadian context; this model asserted women's right to healthy, satisfying, non-procreative sex and the right to make informed choices about their contraceptive needs from among all safe and effective options and free from the intervention of the state and medical authorities. This research project reflects on the success of these two lines of argumentation in both influencing and challenging regulatory policy as well as in shaping societal discourse on reproductive health and sexuality.
Using data from a prospective population-based cohort in France (the Cocon survey, 2001-2004), Caroline Moreau, James Trussell, and Nathalie Bajos (National Institute of Health and Medical Research, France) examined the impact of ECP use on women's regular contraceptive use patterns in the French context of direct pharmacy access to ECPs. Their results show that easy availability of ECPs does not result in the abandonment of regular contraceptive use. However, they also found that use of ECPs does not necessarily result as a bridge to use more effective contraception; while 30 percent of those using a non-highly effective contraceptive or no method at the time of ECP use did switch to a highly effective method, 22 percent of those using a highly effective method at the time of ECP use switched to a less effective or no method.
In a paper published in Obstetrics & Gynecology, James Trussell, Elizabeth Raymond (Family Health International), and Chelsea Polis (Harvard School of Public Health) systematically reviewed data on effects of increased access to emergency contraceptive pills (ECPs) on unintended pregnancy rates and use of the pills. They included studies that compared the effect of different levels of access to emergency contraceptive pills on pregnancy rates, use of the pills, and other outcomes. Of the 717 articles identified, they selected 23 for review. The studies included randomized trials, cohort studies, and evaluations of community interventions. The quality of these studies varied. In all but one study, increased access to emergency contraceptive pills was associated with greater use. However, no study found an impact on pregnancy or abortion rates. They concluded that increased access to emergency contraceptive pills enhances use but has not been shown to reduce unintended pregnancy rates, primarily because ECPs are not used often enough. Specifically, even when women received ECPs at no cost in advance for later use should the need arise, they did not use ECPs in the vast majority of cycles in which pregnancy occurred, primarily because they did not think they were at risk.
James Trussell participated in a hormonal contraceptives trial methodology consensus conference held in September 2005 in Philadelphia. The result was a pair of papers published in Contraception. The first paper provided a description of methodologies applied in the U.S. Food and Drug Administration (FDA) medical officer's review of clinical trial data as contained in the Summary Basis of Approvals of New Drug Applications, results of the review and general conclusions. The authors concluded that data collection methods and analysis of self-reported episodes of bleeding and spotting in combined hormonal contraceptive trials have been highly variable with respect both to definitions and to analytical methods. No standards exist to regulate data collection techniques, methods of reporting, or analysis of bleeding and spotting events during clinical trials of combined hormonal contraceptives. For the purposes of regulatory review of hormonal contraceptives, data regarding the incidence of bleeding and spotting events are not included in either of the traditional categories of efficacy and safety. This lack of standardization has led to publication of confusing and sometimes misleading information about cycle control profiles among combined hormonal contraceptives. The second paper provided recommendations regarding best practices in trial design, data collection, and analysis regarding bleeding data in combined hormone contraception trials. The FDA convened its advisory committee of Reproductive Health Drugs in January 2007 to consider issues involved in clinical trials of combined hormonal contraceptives; Trussell was a member of that committee, which unanimously recommended that the FDA adopt these recommendations.
In a paper published in Contraception, James Trussell estimated the cost of unintended pregnancy in the United States. Despite the many contraceptive options available in the United States, nearly half (49 percent) of the 6.4 million pregnancies each year are unintended; these represent a significant cost to the health care system. The total number of unintended pregnancies and their outcomes were obtained from the literature. Direct medical costs were estimated for each unintended pregnancy outcome. The direct medical costs of unintended pregnancies were $5 billion in 2002. Direct medical cost savings due to contraceptive use were $19 billion. Unintended pregnancies are a costly problem in the United States. Contraceptive use can reduce direct and indirect costs, so payers may realize cost savings by providing coverage of contraceptive products.
In a paper published in Obstetrics & Gynecology, Caroline Moreau, James Trussell, and colleagues in France examined oral contraceptive (OC) tolerance. In recent years, healthcare providers have increasingly favored the prescription of the lowest estrogen dose formulations combined with third-generation progestins, based on theoretical improvements in safety and tolerance. However, no clear evidence supports these choices. This study examines the frequencies of reported symptoms by OC composition among French women. A population-based cohort of 2,863 women studied between 2000 and 2004 was used to compare the frequency of reported symptoms (weight gain, nausea, breast tenderness, lower frequency of menstrual periods, breakthrough bleeding, painful and heavy periods, swollen legs) by type of OCs (classified by estrogen dosage, progestin component, and sequence of administration). Results show little variation in the frequency of symptoms by type of OCs, with the exception of progestin-only pills being associated with higher frequencies of breakthrough bleeding and lower frequencies of menstrual periods. They found no decrease in the reporting of symptoms with the reduction in estrogen dosage, nor with the use of third- compared with second-generation OCs. Likewise, they found little variation by sequence of administration of OCs (monophasic versus triphasic). In the absence of sufficient evidence-based data to support the existence of differences in the tolerance profile of low dose combined OCs, future well-designed randomized trials are needed to guide providers in their choice of OCs. However, research should also assess the effectiveness of counselling on the tolerance of OCs, an intervention that may prove to be more rewarding than basing the choice of OCs on their theoretical properties.
Contraceptive discontinuation contributes significantly to the high rates of unintended pregnancies in the United States. Caroline Moreau, Kelly Cleland, and James Trussell examined contraceptive discontinuation throughout women's lives, focusing specifically on discontinuation due to dissatisfaction with the method. The study population, drawn from the 2002 National Survey of Family Growth, consisted of 6,724 women (15-44 years of age) who had ever used a reversible contraceptive method. They first estimated the proportion of women who discontinued their contraceptive due to dissatisfaction and examined the social and demographic characteristics associated with method discontinuation. They then calculated method-specific discontinuation rates due to dissatisfaction and analyzed the reasons for dissatisfaction given by women who stopped using Norplant, Depo-Provera, oral contraceptives, or condoms. Overall, 46 percent of women discontinued at least one method because they were unsatisfied with it. The likelihood of contraceptive discontinuation due to dissatisfaction depended on women's age, number of partners, parity, and whether they reported a history of unintended pregnancy. Women with the highest level of education and income were also more likely to discontinue their contraceptive due to dissatisfaction. Dissatisfaction-related discontinuation rates varied widely by method: the diaphragm and cervical cap showed the highest rates of discontinuation (52 percent), followed by long-acting hormonal methods, discontinued by 42 percent of users. Oral contraceptives were associated with a 29 percent dissatisfaction related discontinuation rate while condoms had the lowest rate of discontinuation due to dissatisfaction (12 percent). They conclude that a broader understanding of women's concerns and experiences using contraception could help healthcare providers redesign counseling strategies to improve contraceptive continuation.
Using data from a population-based cohort on contraception and abortion in France (Cocon survey), Caroline Moreau, James Trussell, Germán Rodríguez and Jean Bouyer (National Institute of Health and Medical Research, France) estimated method-specific contraceptive failure rates among women in France. They computed their estimates using shared frailty hazards models. They found an overall first year failure rate of 2.9 percent. The IUD had the lowest first year failure rate (1.1 percent), followed by the pill (2.4 percent), the male condom (3.3 percent), fertility awareness methods (7.4 percent), withdrawal (10.1 percent), and spermicides (19.8 percent). The lower contraceptive failure rates among French women compared to those reported for U.S. women suggests differences in contraceptive practices that need to be further explored.
In 2002, Kaiser Permanente health plan in California changed its contraceptive benefits to cover 100 percent of the costs of the most effective forms of contraception (intrauterine contraceptives, injectables, and implants) and for emergency contraceptive pills for all members. The benefit change was advocated by physician leaders across the system as an effort to promote more effective contraceptive use and thereby reduce unintended pregnancies. With colleagues from Kaiser Permanente, James Trussell conducted a retrospective observational study to describe the mix of reversible contraceptives procured before and after the benefit change. They then estimated couple-years of protection to examine whether the contraceptive mix changed to more effective reversible methods. After the benefit change, couple-years of protection increased 28 percent (from 2001-02 to 2003-04) while the caseload of females aged 15-44 fell by one percent. Couple-years of protection for intrauterine contraceptives and injectables rose 137 percent and 32 percent, respectively, while couple-years of protection for the pill, patch, and ring rose only 16 percent. The estimated average annual contraceptive failure rate among women using hormonal contraceptives and intrauterine contraceptives declined from 7.0 percent to 6.4 percent. Use of the levonorgestrel emergency contraceptive pill rose 88 percent. The investigators concluded that removal of the cost of contraception may result in increased utilization of more effective methods and emergency contraceptive pills.
James Trussell and colleagues from the Guttmacher Institute provided updated estimates of contraceptive discontinuation, contraceptive failure, and resumption of contraceptive use for the most commonly used reversible methods in the United States. Estimates were obtained using the 2002 National Survey of Family Growth and the 2001 Abortion Patient Survey to correct for underreporting of abortion in the NSFG. Altogether, 12.4 percent of all episodes of contraceptive use ended with a failure within 12 months after initiation of use. Injectable and oral contraceptives remain the most effective reversible methods used by women in the United States, with probabilities of failure during the first 12 months of use of 7 percent and 9 percent, respectively. The probabilities of failure for withdrawal (18 percent) and the condom (17 percent) are similar. Reliance on fertility-awareness-based methods results in the highest probability of failure (25 percent). There was no clear improvement in contraceptive effectiveness between 1995 and 2002. Altogether, 47 percent of all reversible methods used were discontinued for method-related reasons by the end of 12 months. However, they found that only 20.9 percent of reversible method use is discontinued in the first year if they eliminate change of method as a reason for discontinuation. The male condom was the method most likely to be discontinued (57.1 percent). By comparison, similar levels of method-related reasons for discontinuation in the first year of use were found for withdrawal (54.2 percent) and fertility-awareness-based methods (53.2 percent). Lower levels of discontinuation for method-related reasons were found for the pill (32.7 percent) and for Depo-Provera (44.0 percent). By the end of the first year, 80.3 percent of periods of non-use following discontinuation of use of a contraceptive method had ended with resumption of use of some type of contraceptive. A very high proportion of resumption occurs in the first month that a woman is exposed to risk of unintended pregnancy after discontinuation. Overall, 71.5 percent of non-use intervals had already ended in resumption of use in less than one month.
The UK Medical Eligibility Criteria (UK MEC) were adapted from the WHO Medical Eligibility Criteria to reflect evidenced-based practice in the United Kingdom. One significant change concerns combined hormonal contraceptive (CHC) use and body mass index (BMI). In the UK MEC, use of CHC by women with a BMI of 35-39 has been rated UK MEC 3, and for women with a BMI ≥40, use of CHC has been rated UK MEC 4. This change was prompted by concerns about the effect of CHC use on the risk of venous thromboembolism (VTE). James Trussell, Kate Guthrie (Sexual and Reproductive Healthcare Partnership, Hull and East Yorkshire), and Bimla Schwarz (University of Pittsburgh) reviewed the evidence for that change and examined the consistency of this recommendation with recommendations with respect to age and smoking. They examined five large recent studies of the effect of combined oral contraceptives (COCs) and BMI on VTE. They found that all evidence was expressed as relative risks. When they instead estimate absolute or attributable risks, they conclude that the UK MEC recommendations with respect to CHU use and obesity are inconsistent with those for age and smoking, that use of CHCs among women with a BMI of 35-39 is generally safe and should be changed from a UK MEC 3 to a UK MEC 2, and that there are no data on the safety of use of CHCs among women with a BMI ≥40.
James Trussell was responsible for the chapters on choosing a contraceptive (effectiveness, safety, and personal considerations), emergency contraception, postpartum contraception and lactation, and contraceptive efficacy for the nineteenth edition of Contraceptive Technology, published in late 2007. The Food and Drug Administration has mandated that his summary table of pregnancy rates during typical use and during perfect use of available contraceptive options (Table 27-1) be included in the labeling for all contraceptives marketed in the United States.
Jenny Higgins, Jennifer Hirsch (Columbia University), and James Trussell, in their work on pleasure, prophylaxis, and procreation, produced a qualitative analysis of intermittent contraceptive use and unintended pregnancy. Although pregnancy ambivalence is consistently associated with poorer contraceptive use, little is known about the sexual, social, and emotional dynamics at work in pregnancy ambivalence. The study analyzes qualitative data from in-depth sexual and reproductive history interviews with 36 women and men. Participants were asked about the relational and emotional circumstances surrounding each pregnancy, as well as their thoughts about conceiving a baby with both current and previous partners. Half of respondents had experienced at least one unintended pregnancy. Respondents described three categories of pleasure related to pregnancy ambivalence: active eroticization of risk, in which pregnancy fantasies heightened the charge of the sexual encounter; passive romanticization of pregnancy, in which people neither actively sought nor prevented conception; and an escapist pleasure in imagining that a pregnancy would sweep one away from hardship. All three categories were associated with misuse or nonuse of coitus-dependent methods. For some individuals, the perceived emotional and sexual benefits of conception may outweigh the goal of averting conception, even when a child is not wholly intended. Future behavioral studies should collect more nuanced data on pregnancy-related pleasures. We need to devise clearer clinical guidelines for assessing ambivalence and for linking ambivalent clients with longer-acting methods that are not coitus-dependent.
In a paper published in the July 9, 2009 issue of the New England Journal of Medicine, Mary Fjerstad (Planned Parenthood Federation of America [PPFA]),James Trussell, Irving Sivin (Population Council) Steve Lichtenberg (Northwestern) and Vanessa Cullins (PPFA) sought to determine the rates of serious infection following medical abortion and also to evaluate the association between different infection-reduction measures and changes in the rates of serious infection.
From 2001 to March 2006 Planned Parenthood health centers throughout the United States provided medical abortion principally by a regimen of oral mifepristone followed 24 to 48 hours later by vaginal misoprostol. In response to concerns about serious infections, in early 2006 Planned Parenthood changed the route of misoprostol administration to buccal and required either routine antibiotic coverage or universal screening and treatment for chlamydia; in July 2007, Planned Parenthood began requiring routine antibiotic coverage for all medical abortions.
Rates of serious infection dropped significantly after the joint change to 1) buccal misoprostol replacing vaginal misoprostol and 2) either sexually transmitted infection (STI) testing or routine antibiotic coverage as part of the medical abortion regimen (73% decline from 93/100,000 to 25/100,000 , absolute reduction 67/100,000 [ 95% CI 44-94], p < 0.001). The subsequent change to routine antibiotic coverage led to a further significant reduction in the rate of serious infection (76% decline from 25/100,000 to 6/100,000, absolute reduction 19/100,000 [ 95% CI 2-34], p=0.03). Together, medical abortion with buccal misoprostol combined with routine antibiotic coverage brought the serious infection rate down by 93%, from 93 to 7 per 100,000 (absolute reduction 86/100,000 (95% CI 64-112, p < 0.001). View All Research on Health and Wellbeing
Source: OPR Annual Reports.
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