- Email: [email protected]
Preconception Primary Care: Assessing the “Contraceptive Vital Sign”
On the Edge
Preconception Primary Care Assessing the “Contraceptive Vital Sign”
r
LAURIE LaRUSSO, MS, ELS
Routine assessment of women’s pregnancy intentions and contraceptive use at primary care visits (a “contraceptive vital sign”) is intended to encourage preconception counseling and safe prescribing of teratogenic medications. Researchers from the University of Pittsburgh conducted a randomized controlled trial involving more than 2,300 women to evaluate the effect of a contraceptive vital sign on primary care documentation of contraceptive use and change in provision of family planning services. Their findings were published in the November/December 2012 issue of Annals of Family Medicine. While documentation of contraception remained at 28 percent in the control group, it increased from 23 percent to 57 percent in the intervention group. At visits involving prescription of a teratogenic agent, documentation of contraception increased from 14 percent to 48 percent in the intervention group and decreased from 29 percent to 26 percent in the control group. Despite increases in documentation, provision of new family planning services increased only minimally, including among visits with potentially teratogenic prescriptions. Only 7 percent of women for whom nonuse of contraception was documented and a potentially teratogenic drug was prescribed received family planning services. The authors conclude that, although the contraceptive vital sign is helping to improve contraceptive documentation, more work needs to be done to ensure that contraception and family planning services are offered to all women prescribed a potentially teratogenic medication.
New Drug for Rheumatoid Arthritis In September, the FDA approved tofacitinib (Xeljanz) for treatment of adults with moderately to severely active rheumatoid arthritis who have intolerance to methotrexate or for whom methotrexate has not adequately controlled their symptoms. Rheumatoid arthritis, which affects an estimated 1.5 million Americans, is an autoimmune disease. In rheumatoid arthritis, the body’s immune system attacks healthy tissue, which leads to inflammation of the joints and surrounding tissues. Tofacitinib works by blocking molecules that are important contributors to joint inflammation.
http://nwh.awhonn.org
© 2013, AWHONN
13
On the Edge
Journal of Medicine. Researchers collaborating on a National Institutes of Health study compared the effectiveness of Botox injections with oral anticholinergic medications for treating urge urinary incontinence in nearly 250 women participating in a double-blind, placebo-controlled trial. Episodes of urge urinary incontinence per day declined by 3.3 to 3.4 per day in both treatment groups over the course of the 6-month
Episodes of urge urinary incontinence per day declined by 3.3 to 3.4 per day in both treatment groups over the course of the 6-month study
Treating Urinary Incontinence Oral anticholinergic medications and Botox (onabotulinumtoxinA) injections to the bladder each provide benefit for women with urge urinary incontinence, but with significant side effects, according to a new study published in the November 8, 2012 issue of the New England
study. Significantly, more of the women who received Botox injections (27 percent) reported complete resolution of urge urinary incontinence compared with women taking anticholinergics (13 percent). Quality of life improved to a similar degree in both treatment groups. Anticholinergics were associated with a higher rate of dry mouth (46 percent vs. 31 percent) but lower rates of catheter use for transient urinary retention (0 percent vs. 5 percent) and urinary tract infections (13 percent vs. 33 percent).
New Treatment for Head Lice
Laurie LaRusso, MS, ELS, is a freelance medical writer and an adjunct instructor in the Friedman School of Nutrition Science and Policy at Tufts University in Boston, MA. The author reports no conflicts of interest or relevant financial relationships.
A single application of topical ivermectin lotion can eliminate head lice infestations according to a report of two randomized, double-blind trials published in the November 1, 2012 issue of The New England Journal of Medicine. Researchers compared a single application of 0.5 percent ivermectin lotion with single application of a control lotion (the same lotion without ivermectin) without nit combing in 765 children ages 6 months and older with head lice infestation. The lotion was applied to dry hair, left in for 10 minutes and then rinsed out with water. Significantly, more children treated with the ivermectin lotion, compared with the control lotion, were lousefree on day 2 (95 percent vs. 31 percent), day 8 (85 percent vs. 21 percent) and day 15 (74 percent vs. 18 percent). This finding of a new medication effective at eliminating head lice is important because there is now increasing resistance to the first-line head lice treatments, permethrin and pyrethrins. Moreover, concerns about safety, flammability and unpleasant odor with the secondline treatments, lindane and malathion, limit use of these agents. Two other drugs recently approved by the FDA for treatment of head lice are benzyl alcohol and spinosad.
DOI: 10.1111/1751-486X.12002
14
Nursing for Women’s Health
Volume 17
Issue 1
Cancer Screening and the Affordable Care Act According to a study published in the October 25, 2012 issue of Preventing Chronic Disease, full implementation of the Affordable Care Act could enable more than 1 million low-income women to obtain screening for breast and cervical cancer by expanding health insurance coverage. According to this study, an estimated 500,000 more women each year would be able to get mammograms and 1.3 million more women could get Pap tests.
Leisure Activity and Life Expectancy Drop in U.S. Preterm Birth Rates According to the National Center for Health Statistics, the U.S. preterm birth rate dropped to 11.7 percent in 2011, the lowest in a decade. This rate earned the United States a grade of “C” on the March of Dimes Report Card, which compares states’ preterm birth rates to the March of Dimes goal of 9.6 percent by 2020. The full Report Card is available at www.marchofdimes.com/reportcard.
Synthetic Progresterone for Short Cervix According to a study published in the November 2012 issue of The American Journal of Obstetrics and Gynecology, a synthetic progesterone that is effective for preventing preterm birth in women who delivered preterm in a previous pregnancy does not prevent preterm birth in first pregnancies of women with a short cervix. In 2011, this synthetic form of progesterone (17 alpha-hydroxyprogesterone caproate [17-OHP]) was approved by the FDA to reduce the risk of preterm birth in singleton pregnancies in women who had delivered preterm in a prior pregnancy. Both preterm delivery in a previous pregnancy and short cervix in
February | March 2013
the second trimester are risk factors for preterm delivery. A team of researchers collaborated on this National Institutes of Health network study of 600 firsttime mothers with a short cervix (less than 30 mm) in the second trimester. The women were randomly assigned to receive either a weekly injection of 17-OHP or a placebo to prevent delivery before 37 weeks of gestation. The frequency of preterm delivery was similar for women treated with 17-OHP (25 percent) and placebo (24 percent). In addition, a small difference in composite adverse neonatal outcomes was not statistically significant (17-OHP 7.0 percent vs. placebo 9.1 percent).
People who get more leisure-time physical activity, even at low levels, have a longer life expectancy than those who participate in less leisure-time physical activity, according to a study published in the November 6, 2012 issue of PLoS Medicine. A team of researchers from the United States, Sweden and Finland examined data on more than 650,000 adults, mostly ages 40 and older, who participated in one of six populationbased studies designed to evaluate aspects of cancer risk. They grouped the study participants based on whether they met, did not meet or exceeded the recommended amount physical activity set forth by the U.S. Department of Health and Human Service (DHHS). DHHS recommends that adults ages 18 to 64 engage in regular aerobic physical activity for 2.5 hours at moderate intensity or 1.25 hours at vigorous intensity each week. In this study, life expectancy was 3.4 years longer for people who reported getting the recommended amount of leisure-time physical activity compared with those who reported getting less than the recommended amount. Life expectancy was 4.2 years longer for people who reported they got twice the recommended level of leisure-time physical activity. Overall, more physical activity corresponded to longer life expectancy.
Nursing for Women’s Health
15
On the Edge
Predicting Ovarian Reserve According to a new study published online November 6, 2012 in the journal Human Reproduction, a mother’s age at menopause may predict her daughter’s fertility in terms of the numbers of eggs remaining in her ovaries. Epidemiologic studies had already established a link between mothers’ and daughters’ ages at menopause. This study provides new evidence that early menopause in a mother may be linked to a reduced number of eggs in her daughter’s ovaries during her childbearing years (her ovarian reserve). Researchers at Copenhagen University Hospital in Denmark assessed ovarian reserve in 527 women ages 20 to 44 years by measuring levels of antiMüllerian hormone (AMH) in blood samples and using transvaginal sonography to obtain antral follicle counts (AFC). They compared the ovarian reserves of these women based on their mothers’ age at menopause: early (younger than 45 years), normal (46 to 54 years) and late (older than 55 years). Average AMH
levels declined by 8.6 percent, 6.8 percent and 4.2 percent annually among women whose mothers had early, normal or late menopause, respectively. Similarly, AFC declined by 5.8 percent, 4.7 percent and 3.2 percent per year, respectively. This decline of AMH and AFC related to age at mothers’ menopause was present even after adjusting the analyses to account for various personal factors that could affect the results, such as smoking, contraceptive use, age and body mass index. Based on this study, the authors suggest that maternal age at menopause be considered in combination with AMH, AFC and chronological age when evaluating the ovarian reserve of an individual woman.
Disparities in Breast Cancer Black women are 40 percent more likely to die of breast cancer than white women, according to a Vital Signs report from the Centers for Disease Control and Prevention. Compared to white women, black women had nine more deaths per 100 breast cancers diagnosed and higher rates of advanced-stage breast cancer (45 percent compared with 35 percent). The full report is available at www.cdc.gov/vitalsigns.
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Nursing for Women’s Health
Volume 17
Issue 1
New Drug for Ulcerative Colitis In September, the FDA approved an expanded indication for adalimumab (Humira) to include treatment of moderate-to-severe ulcerative colitis in adults whose symptoms have not responded to immunosuppressant medicines (e.g., corticosteroids, azathioprine and 6-mercaptopurine). Ulcerative colitis causes inflammation and ulcers in the inner lining of the large intestine. Adalimumab is an antitumor necrosis factor that blocks proteins involved in abnormal inflammatory and immune responses. Adalimumab was already approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis and juvenile idiopathic arthritis.
Screening Mammography and Breast Cancer Incidence The benefit of screening mammography has been called into question by a new study published in the November 22nd issue of The New England Journal of Medicine, in which researchers analyzed three decades worth of widespread screening mammography in women 40 years of age or older from the National Health Interview Survey. They examined data from the Surveillance, Epidemiology, and End Results (SEER) database (1976 to 2008) to measure the incidence of early-stage breast cancer and late-stage breast cancer among women ages 40 and older. They found that screening mammography has doubled the number of cases of early-stage breast cancer detected each year, from 112 to 234 cases per 100,000 women—an absolute increase of 122 cases per 100,000. However, the use of screening mammography has only reduced the number of late-stage cancer cases detected from 102 to 94 cases per 100,000 women—a decrease of 8 cases per 100,000 women. Based on their analysis, the researchers estimate that breast cancer has been overdiagnosed in 1.3 million women in
February | March 2013
the United States in the past 30 years, meaning tumors were detected on screening that would never have led to clinical symptoms. Their estimates for 2008 (the last year they studied) indicate that breast cancer was overdiagnosed in more than 70,000 women that year, which accounted for 31 percent of all breast cancers diagnosed. The authors point out that their investigation doesn’t involve a specific group of patients, a specific screening protocol or a single point in time, but rather evaluated national data over a period of three decades and details what has actually happened since the introduction of screening mammography.
Online Patient Access Patients with online access to medical records and clinicians use more clinical services compared with patients who do not have online access, according to a new study published in the November 21, 2012 issue of JAMA. Researchers from the Institute for Health Research, Kaiser Permanente Colorado assessed the health care utilization of more than 88,000 users and nonusers of online access to health records before and after initiation of a patient online access system. Looking at use of clinical services before and after initiation of the online patient access, users of online access increased their rates of office visits by 0.7 per member per year and telephone encounters 0.3 per member per year compared with nonusers. Compared with nonusers, the rate of after-hours clinic visits also increased significantly among users of online access (18.7 per 1,000 members per year), as did emergency department encounters (11.2 per 1,000 members per year) and hospitalizations (19.9 per 1,000 members per year). Earlier studies had suggested that patients with online access to health records and e-mail communications with their health care providers would have reduced utilization of health care services, such as annual office visits, but increased telephone contact. The findings of this study, demonstrating that patients with online access to medical records and email communication use more in-person and telephone health care services, are contrary to expectations and the original intention of providing patients online access.
Nursing for Women’s Health
17
On the Edge
Young People Unaware of HIV Status Young people between the ages of 13 and 24 represent more than a quarter of new HIV infections each year (26 percent) and most of these youth living with HIV (60 percent) are unaware they are infected, according to a Vital Signs report from the Centers for Disease Control and Prevention. The most affected are young gay and bisexual men and African Americans, according to the report. Despite recommendations from CDC and the American Academy of Pediatrics that call for routine HIV testing of youth in medical settings, the analysis
shows that 35 percent of 18- to 24-year-olds have been tested for HIV, while only 13 percent of high school students (and 22 percent of sexually experienced students) have ever been tested. Partially as a result of lower testing levels, HIV-infected people under the age of 25 are significantly less likely than those who are older to get and stay in HIV care, and to have their virus controlled at a level that helps them stay healthy and reduce their risk of transmitting HIV to partners. Access the full report at www.cdc.gov/ vitalsigns/HIVAmongYouth/index.html.
Five Strategies to Prevent Prematurity Very high resource nations, including the United States, can employ a few proven interventions to achieve the international goal of lowering preterm birth rates by 5 percent, according to a new study published online November 16, 2012 in The Lancet. The goal of 5 percent reduction in preterm birth rates by 2015 was set forth in the May 2012 publication Born Too Soon: The Global Action Report on Preterm Birth. For the Lancet paper, an international group of researchers analyzed preterm birth data from 39 countries with very high human development index (i.e., high-resource nations), including the United States, for the years 2000 to 2010. They also analyzed the factors driving the increase in preterm delivery rates in the United States between 1989 and 2004. For all 39 countries, they identified five interventions that predicted a 5 percent relative reduction of preterm birth rate from 9.6 percent to 9.1 percent of live births. The interventions were smoking cessation, decreasing multiple embryo transfers during assisted reproductive technology, cervical cerclage for incompetent cervix, progesterone supplementation and reduction of nonmedically indicated labor induction or cesarean surgical birth. According to their economic analysis, employing these five strategies in high-resource nations would avert approximately 58,000 preterm births and produce annual cost savings of about $3 billion. While about half of the rise in the preterm birth rate in the United States from 1989 to 2004 remains unexplained, two important drivers of the increase were the use of assisted reproductive technologies and nonmedically indicated labor induction and cesarean surgical birth. The authors point out that these strategies are targeted to address drivers of preterm birth in high-income nations, only some of which are at play in middle- and low-income countries. The highest preterm birth rates occur in low-income nations, where other underlying causes of prematurity require different solutions, for example, birth spacing, treatment of maternal infections in pregnancy and improved nutrition.
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Nursing for Women’s Health
Volume 17
Issue 1
Compounding Pharmacies Two articles published online November 7, 2012 in The New England Journal of Medicine provide valuable perspective on the role of compounding pharmacies in the wake of the recent outbreak of fungal meningitis linked to the injectable glucocorticoid methylprednisolone acetate compounded by the New England Compounding Center (NECC). Compounding pharmacies produce, package or repackage specific drugs for individual patients based on specific needs of those patients. Examples of the customized medications made by compounding pharmacies include individualized chemotherapeutic agents, doses or formulations (e.g., liquid rather than tablet) not available from the drug manufacturer, preservative-free and dye-free medications, flavored drugs and medications with specific allergens removed. In this way, compounding pharmacies provide essential products for patients with specific or unique medication needs. An essential aspect of safety and infection control in the practice of pharmaceutical compounding is that each individual prescription is formulated in response to a specialized prescription for a specific patient.
When drugs are made in large batches for unidentified groups of patients, the process is no longer compounding; it’s manufacturing, a process with many controls to ensure sterility of the drugs and that is tightly regulated by the FDA to ensure the safety of the manufacturing process. Compounding, however, is overseen at the state level by agencies, such as state boards of pharmacy. With the discovery that NECC was operating outside the scope of its traditional compounding license by manufacturing methylprednisolone acetate injections in large batches and selling them
to physician offices around the country, calls for FDA oversight of compounding pharmacies have begun in earnest. The Verifying Authority and Legality in Drug (VALID) Compounding Act has been introduced in the House of Representatives. This bill would give the FDA broader powers to regulate compounding pharmacies by placing the pharmacies that operate as drug manufacturers under FDA regulation and leaving in place state regulatory authority over traditional compounding pharmacies that make customized drugs for individual patients.
Infection Control and Ultrasound Gel In the December 2012 issue of Infection Control and Hospital Epidemiology, researchers from Michigan highlight a need for standards to prevent transmission of infection through ultrasound transmission gels. Citing seven outbreaks of infection linked to ultrasound transmission gels in U.S. hospitals, including five university-affiliated hospitals, the authors call on ultrasound gel manufacturers and professional societies to develop recommendations for infection control with the use of these gels. Two of the outbreaks involved OB-GYN and/or neonatal use of ultrasound gels. The article includes an outline of initial guidelines for preventing transmission of infection through ultrasound transmission gels, including use of single-dose, sterile ultrasound gel for procedures involving mucous membranes, when scanning nonintact skin or near fresh surgical wounds, and for neonates and critically ill pediatric patients. Due to reported outbreaks related to use of water baths to warm ultrasound gel, they recommend dry heat as the preferred warming method. They also recommend that nonsterile gel (single dose or multidose) be reserved for use on intact skin and that, when multidose containers of nonsterile gel are used, the container be sealed appropriately when not in use and never be washed and refilled for reuse.
February | March 2013
Nursing for Women’s Health
19
On the Edge
Prenatal Alcohol and Brain Development Heavy drinking during pregnancy can have lasting consequences for the growth and development of a child’s brain, according to a study published in the October 31, 2012 issue of The Journal of Neuroscience. A team of researchers affiliated with the Collaborative Initiative on Fetal Alcohol Spectrum Disorders used structural magnetic resonance imaging (MRI) to measure changes in the brain’s cortical volume in 70 children and teens with heavy prenatal alcohol exposure (13 drinks per week on average) and 63 unexposed children. The children were ages 5 to 16 years, with an average age of 12. MRI images of unexposed children showed typical rapid increases in brain volume during the younger years followed by reduction in volume of the cerebral cortex during adolescence, a process that clears away underused brain connections to increase efficiency. In the children heavily exposed to alcohol in utero, MRI images typically showed only loss of cortical volume without the period of rapid growth. In addition, heavier alcohol exposure was associated with lower
intelligence, greater facial abnormalities and little change in brain volume between scans. These findings indicate that the normal processes of brain maturation are disrupted in children whose mothers drank heavily during pregnancy. Specifically, the brain’s ability to grow and remodel itself based on experiences with the outside world was decreased in children exposed to alcohol compared with unexposed children. This deficit has lifelong implications, because this adaptation of the brain is important throughout life and crucial to learning new skills and adapting to one’s environment. The researchers acknowledge that the differences in brain maturation seen in this study could also be related to dysfunctional experiences throughout childhood and adolescence, which may be more likely among children whose mothers drank heavily during pregnancy than children not exposed to alcohol in utero.
SSRI Use in Pregnancy For women with fertility problems and depressive symptoms during pregnancy, the prevailing opinion has been that the benefit of antidepressant drugs outweighs the risk of untreated depression during pregnancy. A new literature review, published online October 31, 2012 in the journal Human Reproduction, has called this approach into question. Researchers from the Harvard University and Tufts University schools of medicine reviewed the current literature on the safety and efficacy of selective serotonin reuptake inhibitor (SSRI) use in women being treated for infertility. They found no evidence of improved pregnancy outcomes with antidepressant use. However, they did find the use of SSRIs during pregnancy to be associated with increased risks of miscarriage, birth defects, preterm birth, newborn behavioral syndrome, persistent pulmonary hypertension of the
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Nursing for Women’s Health
newborn and possible longer term neurobehavioral effects. With this literature review, the authors have provided a more comprehensive picture of the risks identified in individual studies of SSRI use before and during pregnancy, including increased risk of miscarriage, birth defects, preterm birth, preeclampsia, newborn behavioral syndrome, neonatal prolonged QT syndrome, persistent pulmonary hypertension of the newborn and long-term neurobehavioral changes. Furthermore, recent research suggests that, as in the general population, some forms of counseling, including cognitive behavioral therapy, can be effective in treating depressive symptoms in infertile women. The authors advocate for health care providers to discuss with their female patients taking antidepressants the risks and benefits of continuing their medication if they’re considering becoming pregnant.
Volume 17
Issue 1
Preconception Primary Care Assessing the “Contraceptive Vital Sign”
r
LAURIE LaRUSSO, MS, ELS
Routine assessment of women’s pregnancy intentions and contraceptive use at primary care visits (a “contraceptive vital sign”) is intended to encourage preconception counseling and safe prescribing of teratogenic medications. Researchers from the University of Pittsburgh conducted a randomized controlled trial involving more than 2,300 women to evaluate the effect of a contraceptive vital sign on primary care documentation of contraceptive use and change in provision of family planning services. Their findings were published in the November/December 2012 issue of Annals of Family Medicine. While documentation of contraception remained at 28 percent in the control group, it increased from 23 percent to 57 percent in the intervention group. At visits involving prescription of a teratogenic agent, documentation of contraception increased from 14 percent to 48 percent in the intervention group and decreased from 29 percent to 26 percent in the control group. Despite increases in documentation, provision of new family planning services increased only minimally, including among visits with potentially teratogenic prescriptions. Only 7 percent of women for whom nonuse of contraception was documented and a potentially teratogenic drug was prescribed received family planning services. The authors conclude that, although the contraceptive vital sign is helping to improve contraceptive documentation, more work needs to be done to ensure that contraception and family planning services are offered to all women prescribed a potentially teratogenic medication.
New Drug for Rheumatoid Arthritis In September, the FDA approved tofacitinib (Xeljanz) for treatment of adults with moderately to severely active rheumatoid arthritis who have intolerance to methotrexate or for whom methotrexate has not adequately controlled their symptoms. Rheumatoid arthritis, which affects an estimated 1.5 million Americans, is an autoimmune disease. In rheumatoid arthritis, the body’s immune system attacks healthy tissue, which leads to inflammation of the joints and surrounding tissues. Tofacitinib works by blocking molecules that are important contributors to joint inflammation.
http://nwh.awhonn.org
© 2013, AWHONN
13
On the Edge
Journal of Medicine. Researchers collaborating on a National Institutes of Health study compared the effectiveness of Botox injections with oral anticholinergic medications for treating urge urinary incontinence in nearly 250 women participating in a double-blind, placebo-controlled trial. Episodes of urge urinary incontinence per day declined by 3.3 to 3.4 per day in both treatment groups over the course of the 6-month
Episodes of urge urinary incontinence per day declined by 3.3 to 3.4 per day in both treatment groups over the course of the 6-month study
Treating Urinary Incontinence Oral anticholinergic medications and Botox (onabotulinumtoxinA) injections to the bladder each provide benefit for women with urge urinary incontinence, but with significant side effects, according to a new study published in the November 8, 2012 issue of the New England
study. Significantly, more of the women who received Botox injections (27 percent) reported complete resolution of urge urinary incontinence compared with women taking anticholinergics (13 percent). Quality of life improved to a similar degree in both treatment groups. Anticholinergics were associated with a higher rate of dry mouth (46 percent vs. 31 percent) but lower rates of catheter use for transient urinary retention (0 percent vs. 5 percent) and urinary tract infections (13 percent vs. 33 percent).
New Treatment for Head Lice
Laurie LaRusso, MS, ELS, is a freelance medical writer and an adjunct instructor in the Friedman School of Nutrition Science and Policy at Tufts University in Boston, MA. The author reports no conflicts of interest or relevant financial relationships.
A single application of topical ivermectin lotion can eliminate head lice infestations according to a report of two randomized, double-blind trials published in the November 1, 2012 issue of The New England Journal of Medicine. Researchers compared a single application of 0.5 percent ivermectin lotion with single application of a control lotion (the same lotion without ivermectin) without nit combing in 765 children ages 6 months and older with head lice infestation. The lotion was applied to dry hair, left in for 10 minutes and then rinsed out with water. Significantly, more children treated with the ivermectin lotion, compared with the control lotion, were lousefree on day 2 (95 percent vs. 31 percent), day 8 (85 percent vs. 21 percent) and day 15 (74 percent vs. 18 percent). This finding of a new medication effective at eliminating head lice is important because there is now increasing resistance to the first-line head lice treatments, permethrin and pyrethrins. Moreover, concerns about safety, flammability and unpleasant odor with the secondline treatments, lindane and malathion, limit use of these agents. Two other drugs recently approved by the FDA for treatment of head lice are benzyl alcohol and spinosad.
DOI: 10.1111/1751-486X.12002
14
Nursing for Women’s Health
Volume 17
Issue 1
Cancer Screening and the Affordable Care Act According to a study published in the October 25, 2012 issue of Preventing Chronic Disease, full implementation of the Affordable Care Act could enable more than 1 million low-income women to obtain screening for breast and cervical cancer by expanding health insurance coverage. According to this study, an estimated 500,000 more women each year would be able to get mammograms and 1.3 million more women could get Pap tests.
Leisure Activity and Life Expectancy Drop in U.S. Preterm Birth Rates According to the National Center for Health Statistics, the U.S. preterm birth rate dropped to 11.7 percent in 2011, the lowest in a decade. This rate earned the United States a grade of “C” on the March of Dimes Report Card, which compares states’ preterm birth rates to the March of Dimes goal of 9.6 percent by 2020. The full Report Card is available at www.marchofdimes.com/reportcard.
Synthetic Progresterone for Short Cervix According to a study published in the November 2012 issue of The American Journal of Obstetrics and Gynecology, a synthetic progesterone that is effective for preventing preterm birth in women who delivered preterm in a previous pregnancy does not prevent preterm birth in first pregnancies of women with a short cervix. In 2011, this synthetic form of progesterone (17 alpha-hydroxyprogesterone caproate [17-OHP]) was approved by the FDA to reduce the risk of preterm birth in singleton pregnancies in women who had delivered preterm in a prior pregnancy. Both preterm delivery in a previous pregnancy and short cervix in
February | March 2013
the second trimester are risk factors for preterm delivery. A team of researchers collaborated on this National Institutes of Health network study of 600 firsttime mothers with a short cervix (less than 30 mm) in the second trimester. The women were randomly assigned to receive either a weekly injection of 17-OHP or a placebo to prevent delivery before 37 weeks of gestation. The frequency of preterm delivery was similar for women treated with 17-OHP (25 percent) and placebo (24 percent). In addition, a small difference in composite adverse neonatal outcomes was not statistically significant (17-OHP 7.0 percent vs. placebo 9.1 percent).
People who get more leisure-time physical activity, even at low levels, have a longer life expectancy than those who participate in less leisure-time physical activity, according to a study published in the November 6, 2012 issue of PLoS Medicine. A team of researchers from the United States, Sweden and Finland examined data on more than 650,000 adults, mostly ages 40 and older, who participated in one of six populationbased studies designed to evaluate aspects of cancer risk. They grouped the study participants based on whether they met, did not meet or exceeded the recommended amount physical activity set forth by the U.S. Department of Health and Human Service (DHHS). DHHS recommends that adults ages 18 to 64 engage in regular aerobic physical activity for 2.5 hours at moderate intensity or 1.25 hours at vigorous intensity each week. In this study, life expectancy was 3.4 years longer for people who reported getting the recommended amount of leisure-time physical activity compared with those who reported getting less than the recommended amount. Life expectancy was 4.2 years longer for people who reported they got twice the recommended level of leisure-time physical activity. Overall, more physical activity corresponded to longer life expectancy.
Nursing for Women’s Health
15
On the Edge
Predicting Ovarian Reserve According to a new study published online November 6, 2012 in the journal Human Reproduction, a mother’s age at menopause may predict her daughter’s fertility in terms of the numbers of eggs remaining in her ovaries. Epidemiologic studies had already established a link between mothers’ and daughters’ ages at menopause. This study provides new evidence that early menopause in a mother may be linked to a reduced number of eggs in her daughter’s ovaries during her childbearing years (her ovarian reserve). Researchers at Copenhagen University Hospital in Denmark assessed ovarian reserve in 527 women ages 20 to 44 years by measuring levels of antiMüllerian hormone (AMH) in blood samples and using transvaginal sonography to obtain antral follicle counts (AFC). They compared the ovarian reserves of these women based on their mothers’ age at menopause: early (younger than 45 years), normal (46 to 54 years) and late (older than 55 years). Average AMH
levels declined by 8.6 percent, 6.8 percent and 4.2 percent annually among women whose mothers had early, normal or late menopause, respectively. Similarly, AFC declined by 5.8 percent, 4.7 percent and 3.2 percent per year, respectively. This decline of AMH and AFC related to age at mothers’ menopause was present even after adjusting the analyses to account for various personal factors that could affect the results, such as smoking, contraceptive use, age and body mass index. Based on this study, the authors suggest that maternal age at menopause be considered in combination with AMH, AFC and chronological age when evaluating the ovarian reserve of an individual woman.
Disparities in Breast Cancer Black women are 40 percent more likely to die of breast cancer than white women, according to a Vital Signs report from the Centers for Disease Control and Prevention. Compared to white women, black women had nine more deaths per 100 breast cancers diagnosed and higher rates of advanced-stage breast cancer (45 percent compared with 35 percent). The full report is available at www.cdc.gov/vitalsigns.
16
Nursing for Women’s Health
Volume 17
Issue 1
New Drug for Ulcerative Colitis In September, the FDA approved an expanded indication for adalimumab (Humira) to include treatment of moderate-to-severe ulcerative colitis in adults whose symptoms have not responded to immunosuppressant medicines (e.g., corticosteroids, azathioprine and 6-mercaptopurine). Ulcerative colitis causes inflammation and ulcers in the inner lining of the large intestine. Adalimumab is an antitumor necrosis factor that blocks proteins involved in abnormal inflammatory and immune responses. Adalimumab was already approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis and juvenile idiopathic arthritis.
Screening Mammography and Breast Cancer Incidence The benefit of screening mammography has been called into question by a new study published in the November 22nd issue of The New England Journal of Medicine, in which researchers analyzed three decades worth of widespread screening mammography in women 40 years of age or older from the National Health Interview Survey. They examined data from the Surveillance, Epidemiology, and End Results (SEER) database (1976 to 2008) to measure the incidence of early-stage breast cancer and late-stage breast cancer among women ages 40 and older. They found that screening mammography has doubled the number of cases of early-stage breast cancer detected each year, from 112 to 234 cases per 100,000 women—an absolute increase of 122 cases per 100,000. However, the use of screening mammography has only reduced the number of late-stage cancer cases detected from 102 to 94 cases per 100,000 women—a decrease of 8 cases per 100,000 women. Based on their analysis, the researchers estimate that breast cancer has been overdiagnosed in 1.3 million women in
February | March 2013
the United States in the past 30 years, meaning tumors were detected on screening that would never have led to clinical symptoms. Their estimates for 2008 (the last year they studied) indicate that breast cancer was overdiagnosed in more than 70,000 women that year, which accounted for 31 percent of all breast cancers diagnosed. The authors point out that their investigation doesn’t involve a specific group of patients, a specific screening protocol or a single point in time, but rather evaluated national data over a period of three decades and details what has actually happened since the introduction of screening mammography.
Online Patient Access Patients with online access to medical records and clinicians use more clinical services compared with patients who do not have online access, according to a new study published in the November 21, 2012 issue of JAMA. Researchers from the Institute for Health Research, Kaiser Permanente Colorado assessed the health care utilization of more than 88,000 users and nonusers of online access to health records before and after initiation of a patient online access system. Looking at use of clinical services before and after initiation of the online patient access, users of online access increased their rates of office visits by 0.7 per member per year and telephone encounters 0.3 per member per year compared with nonusers. Compared with nonusers, the rate of after-hours clinic visits also increased significantly among users of online access (18.7 per 1,000 members per year), as did emergency department encounters (11.2 per 1,000 members per year) and hospitalizations (19.9 per 1,000 members per year). Earlier studies had suggested that patients with online access to health records and e-mail communications with their health care providers would have reduced utilization of health care services, such as annual office visits, but increased telephone contact. The findings of this study, demonstrating that patients with online access to medical records and email communication use more in-person and telephone health care services, are contrary to expectations and the original intention of providing patients online access.
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Young People Unaware of HIV Status Young people between the ages of 13 and 24 represent more than a quarter of new HIV infections each year (26 percent) and most of these youth living with HIV (60 percent) are unaware they are infected, according to a Vital Signs report from the Centers for Disease Control and Prevention. The most affected are young gay and bisexual men and African Americans, according to the report. Despite recommendations from CDC and the American Academy of Pediatrics that call for routine HIV testing of youth in medical settings, the analysis
shows that 35 percent of 18- to 24-year-olds have been tested for HIV, while only 13 percent of high school students (and 22 percent of sexually experienced students) have ever been tested. Partially as a result of lower testing levels, HIV-infected people under the age of 25 are significantly less likely than those who are older to get and stay in HIV care, and to have their virus controlled at a level that helps them stay healthy and reduce their risk of transmitting HIV to partners. Access the full report at www.cdc.gov/ vitalsigns/HIVAmongYouth/index.html.
Five Strategies to Prevent Prematurity Very high resource nations, including the United States, can employ a few proven interventions to achieve the international goal of lowering preterm birth rates by 5 percent, according to a new study published online November 16, 2012 in The Lancet. The goal of 5 percent reduction in preterm birth rates by 2015 was set forth in the May 2012 publication Born Too Soon: The Global Action Report on Preterm Birth. For the Lancet paper, an international group of researchers analyzed preterm birth data from 39 countries with very high human development index (i.e., high-resource nations), including the United States, for the years 2000 to 2010. They also analyzed the factors driving the increase in preterm delivery rates in the United States between 1989 and 2004. For all 39 countries, they identified five interventions that predicted a 5 percent relative reduction of preterm birth rate from 9.6 percent to 9.1 percent of live births. The interventions were smoking cessation, decreasing multiple embryo transfers during assisted reproductive technology, cervical cerclage for incompetent cervix, progesterone supplementation and reduction of nonmedically indicated labor induction or cesarean surgical birth. According to their economic analysis, employing these five strategies in high-resource nations would avert approximately 58,000 preterm births and produce annual cost savings of about $3 billion. While about half of the rise in the preterm birth rate in the United States from 1989 to 2004 remains unexplained, two important drivers of the increase were the use of assisted reproductive technologies and nonmedically indicated labor induction and cesarean surgical birth. The authors point out that these strategies are targeted to address drivers of preterm birth in high-income nations, only some of which are at play in middle- and low-income countries. The highest preterm birth rates occur in low-income nations, where other underlying causes of prematurity require different solutions, for example, birth spacing, treatment of maternal infections in pregnancy and improved nutrition.
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Volume 17
Issue 1
Compounding Pharmacies Two articles published online November 7, 2012 in The New England Journal of Medicine provide valuable perspective on the role of compounding pharmacies in the wake of the recent outbreak of fungal meningitis linked to the injectable glucocorticoid methylprednisolone acetate compounded by the New England Compounding Center (NECC). Compounding pharmacies produce, package or repackage specific drugs for individual patients based on specific needs of those patients. Examples of the customized medications made by compounding pharmacies include individualized chemotherapeutic agents, doses or formulations (e.g., liquid rather than tablet) not available from the drug manufacturer, preservative-free and dye-free medications, flavored drugs and medications with specific allergens removed. In this way, compounding pharmacies provide essential products for patients with specific or unique medication needs. An essential aspect of safety and infection control in the practice of pharmaceutical compounding is that each individual prescription is formulated in response to a specialized prescription for a specific patient.
When drugs are made in large batches for unidentified groups of patients, the process is no longer compounding; it’s manufacturing, a process with many controls to ensure sterility of the drugs and that is tightly regulated by the FDA to ensure the safety of the manufacturing process. Compounding, however, is overseen at the state level by agencies, such as state boards of pharmacy. With the discovery that NECC was operating outside the scope of its traditional compounding license by manufacturing methylprednisolone acetate injections in large batches and selling them
to physician offices around the country, calls for FDA oversight of compounding pharmacies have begun in earnest. The Verifying Authority and Legality in Drug (VALID) Compounding Act has been introduced in the House of Representatives. This bill would give the FDA broader powers to regulate compounding pharmacies by placing the pharmacies that operate as drug manufacturers under FDA regulation and leaving in place state regulatory authority over traditional compounding pharmacies that make customized drugs for individual patients.
Infection Control and Ultrasound Gel In the December 2012 issue of Infection Control and Hospital Epidemiology, researchers from Michigan highlight a need for standards to prevent transmission of infection through ultrasound transmission gels. Citing seven outbreaks of infection linked to ultrasound transmission gels in U.S. hospitals, including five university-affiliated hospitals, the authors call on ultrasound gel manufacturers and professional societies to develop recommendations for infection control with the use of these gels. Two of the outbreaks involved OB-GYN and/or neonatal use of ultrasound gels. The article includes an outline of initial guidelines for preventing transmission of infection through ultrasound transmission gels, including use of single-dose, sterile ultrasound gel for procedures involving mucous membranes, when scanning nonintact skin or near fresh surgical wounds, and for neonates and critically ill pediatric patients. Due to reported outbreaks related to use of water baths to warm ultrasound gel, they recommend dry heat as the preferred warming method. They also recommend that nonsterile gel (single dose or multidose) be reserved for use on intact skin and that, when multidose containers of nonsterile gel are used, the container be sealed appropriately when not in use and never be washed and refilled for reuse.
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Prenatal Alcohol and Brain Development Heavy drinking during pregnancy can have lasting consequences for the growth and development of a child’s brain, according to a study published in the October 31, 2012 issue of The Journal of Neuroscience. A team of researchers affiliated with the Collaborative Initiative on Fetal Alcohol Spectrum Disorders used structural magnetic resonance imaging (MRI) to measure changes in the brain’s cortical volume in 70 children and teens with heavy prenatal alcohol exposure (13 drinks per week on average) and 63 unexposed children. The children were ages 5 to 16 years, with an average age of 12. MRI images of unexposed children showed typical rapid increases in brain volume during the younger years followed by reduction in volume of the cerebral cortex during adolescence, a process that clears away underused brain connections to increase efficiency. In the children heavily exposed to alcohol in utero, MRI images typically showed only loss of cortical volume without the period of rapid growth. In addition, heavier alcohol exposure was associated with lower
intelligence, greater facial abnormalities and little change in brain volume between scans. These findings indicate that the normal processes of brain maturation are disrupted in children whose mothers drank heavily during pregnancy. Specifically, the brain’s ability to grow and remodel itself based on experiences with the outside world was decreased in children exposed to alcohol compared with unexposed children. This deficit has lifelong implications, because this adaptation of the brain is important throughout life and crucial to learning new skills and adapting to one’s environment. The researchers acknowledge that the differences in brain maturation seen in this study could also be related to dysfunctional experiences throughout childhood and adolescence, which may be more likely among children whose mothers drank heavily during pregnancy than children not exposed to alcohol in utero.
SSRI Use in Pregnancy For women with fertility problems and depressive symptoms during pregnancy, the prevailing opinion has been that the benefit of antidepressant drugs outweighs the risk of untreated depression during pregnancy. A new literature review, published online October 31, 2012 in the journal Human Reproduction, has called this approach into question. Researchers from the Harvard University and Tufts University schools of medicine reviewed the current literature on the safety and efficacy of selective serotonin reuptake inhibitor (SSRI) use in women being treated for infertility. They found no evidence of improved pregnancy outcomes with antidepressant use. However, they did find the use of SSRIs during pregnancy to be associated with increased risks of miscarriage, birth defects, preterm birth, newborn behavioral syndrome, persistent pulmonary hypertension of the
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newborn and possible longer term neurobehavioral effects. With this literature review, the authors have provided a more comprehensive picture of the risks identified in individual studies of SSRI use before and during pregnancy, including increased risk of miscarriage, birth defects, preterm birth, preeclampsia, newborn behavioral syndrome, neonatal prolonged QT syndrome, persistent pulmonary hypertension of the newborn and long-term neurobehavioral changes. Furthermore, recent research suggests that, as in the general population, some forms of counseling, including cognitive behavioral therapy, can be effective in treating depressive symptoms in infertile women. The authors advocate for health care providers to discuss with their female patients taking antidepressants the risks and benefits of continuing their medication if they’re considering becoming pregnant.
Volume 17
Issue 1