A recent observational study compared the safety of estradiol and conjugated equine estrogen. Of the two, estradiol was associated with a lower risk of leg vein and lung clots.

Researchers found that women patients at Group Health Cooperative who were prescribed estradiol had fewer of these blood vessel clots than did those prescribed Premarin. Estradiol is a generic, bio-equivalent estrogen. Premarin, a patented drug, is a conjugated equine estrogen.

91探花 and Group Health Research Institute conducted the study. The results will be published this week in JAMA Internal Medicine.

“Although oral estrogens are effective for managing menopause symptoms, not enough is known about the cardiovascular safety of different oral hormone therapy products relative to each other,” said first author Nicholas L. Smith, professor of epidemiology at the 91探花School of Public Health. Smith directs the Veterans Affairs Seattle Epidemiologic Research and Information Center at the VA Puget Sound Health Care System. He is also an affiliate investigator at Group Health Research Institute.

To further understand the differences in risk, researchers measured clotting factors in the blood of women who did not develop a clot. Compared with estradiol users, conjugated equine estrogen users had levels that made them more prone to form blood clots, the researchers found.

The researchers also investigated the risk of heart attack and stroke, and found:

• The risk of heart attack was somewhat, but not significantly, higher in women using oral conjugated equine estrogens than in those using oral estradiol.
• No difference in the risk of stroke.

鈥淚f our results are confirmed,鈥� Smith added, 鈥渨omen seeking menopausal treatment and their providers would find this information helpful when selecting a drug.鈥�

This project, part of the Heart and Vascular Health study, included 384 Group Health members, aged 30 to 79, who were taking oral estrogen for menopause symptoms from 2003 through 2009. Menopausal symptoms can 聽include hot flashes, night sweats and vaginal dryness, burning, and irritation.

On Feb. 1, 2005, Group Health鈥檚 pharmacy formulary (list of medicines) switched its preferred oral estrogen from conjugated equine estrogens to estradiol. The Heart and Vascular Health study is a case-control study in which Group Health members who have experienced cardiovascular events, such as heart attack or stroke, are matched with members who have not.

Smith鈥檚 co-authors were Marc Blondona, visiting scholar from the University Hospitals of Geneva, Switzerland; Leiden University Medical Center investigators Astrid van Hylckama Vlieg聽 and Frits R. Rosendaal,; and 91探花investigators Kerri L. Wiggins, Laura B. Harrington, James S. Floyd, Melody Hwang, Joshua C. Bis, Barbara McKnight, Kenneth M. Rice, Thomas Lumley, 聽Susan R. Heckbert and Bruce M. Psaty. At Group Health Research Institute,,Psaty is a senior investigator and Heckbert is an affiliate investigator.

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The Heart and Vascular Health study is supported by grants HL43201, HL60739, HL68986, HL734105, HL7474, HL85251, and HL95080 from the National Heart, Lung, and Blood Institute of the National Institutes of Health.

Primary-care clinicians know teen depression is common, but they’ve lacked a reliable screening test for it. Based on the results of a recent study, researchers can now report that a brief, nine-item patient health questionnaire, called the , is a good screening test for major depression in teenagers.

Led by adolescent medicine specialist the research team tested the PHQ-9 as a screening tool for depression in 442 teenagers, age 13-17, who were patients at Group Health. The test is brief, available free of charge, easy to score and understand, and proven in adults to find major depression that fits standard, diagnostic criteria. This study, the first to assess the screening tool in teens, is in the November 2010 Pediatrics.

“This is important not only because depression is relatively common among adolescents, but also because we have effective treatment for them,” said Richardson. She is an associate professor of pediatrics at the UW, an adolescent medicine specialist at Seattle Children’s, and an affiliate investigator at Group Health Research Institute. “Primary care clinicians are advised to screen teens for depression,” she said, “and they need a convenient tool like this.” The team of researchers were from the Group Health, Children’s and the UW

The team compared the PHQ-9 to the more labor-intensive gold standard, an independent structured mental health interview called the Child Diagnostic Interview Schedule 4 (DISC-IV), and to published data on use of the screening test in adults.

They found that the PHQ-9 had a sensitivity (89.5%) and specificity (77.5%) in teens are similar to those in adults.

Sensitivity is a measure of a test’s ability to correctly identify people who have the disease in question, or a true positive. Specificity measures how accurately a test identifies people who don’t have the condition, or a true negative.

They found, however, that the best cut point for maximizing the PHQ-9 screening test’s sensitivity without losing specificity is higher among teens than in adults. A cut point is a mark above which test results are considered to indicate disease, and below which the results are considered normal. A cut point can be adjusted for different clinical situations depending on whether the goal is to reduce false positives or false negatives.

The team interpreted that their study data showed that the PHQ-9 is a suitable choice for health-care professionals and researchers who want to screen for depression in teens in primary care.

Depression raises risks of advanced and severe complications from diabetes, according to a prospective study of Group Health primary-care patients in western Washington. These complications include kidney failure or blindness, the result of small vessel damage, as well as major vessel problems leading to heart attack or stroke.

The findings were published this week in Diabetes Care, a scientific journal of the American Diabetes Association. The study was conducted by scientists from the Group Health Research Institute, Seattle; the 91探花 School of Medicine and School of Public Health, and the Veterans Affairs Puget Sound Health Care System. The lead author is Dr. Elizabeth Lin of the Group Health Research Institute.

Among their research volunteers with type 2 diabetes followed over 5 years, major depression was associated with a 36 percent higher risk of developing advanced micro-vascular complications, such as end-stage kidney disease or blindness, and a 25 percent higher risk of developing advanced macrovascular complications, such as stroke or myocardial infarction (heart attack from a blood clot), compared with diabetes patients without depression. The clinically significant risks remained even after the researchers adjusted for diabetes severity and self-care activities.

Between 2000 and 2002, the Pathways Epidemiological Follow-up Study enrolled 4,632 primary-care Group Health Cooperative patients with diabetes. These patients were tracked through 2005-2007. The final sample size was 3,922. The researchers reviewed medical records, diagnostic and procedural codes, lists of prescribed medications, and death certificates to determine what happened to each patient over nearly five years. The researchers used proportional hazard models to calculate the association between depression and the risk of advanced complications. Even among patients with diabetes who had no prior indication of microvascular or macrovascular problems, depression increased the chances that these problems would develop.

As in earlier reports, the diabetes patients with major depression tended to be slightly younger, heavier, have more co-existing medical conditions, and were more likely to be treated with insulin than were diabetes patients without depression. They also had higher levels of a substance in the blood formed when the sugar glucose attaches to hemoglobin, an oxygen-carrying protein. The major depression group had a higher proportion of women and smokers. However, after controlling for these differences between depressed and non-depressed patients with diabetes, the increased risk of complications associated with depression remained.

Several previous studies suggest the negative relationship between depression and diabetes cuts both ways. People with depression are prone to diabetes, and vice versa. Impairment from diabetes, such as blindness or kidney failure requiring long-term dialysis, interferes with a person’s daily life and can be overwhelming. The person may become depressed or an existing depression may worsen.

As the incidence of type 2 diabetes soars, the clinical and public health significance of these findings increases, the authors noted. Further research is needed, the authors added, to clarify the underlying biological mechanism for the association between depression and complications of diabetes, and to test interventions which might be effective in lowering the risk of complications among patients who have both diabetes and depression.

In addition to Lin, the researchers on the study were Dr. Carolyn M. Rutter, Malia Oliver, Dr. Evette Ludman, Dr. David McCulloch and Dr. Michael Van Korff of the Group Health Research Institute in Seattle; Dr. Wayne Katon and Dr. Paul Ciechanowski, both of the 91探花Department of Psychiatry and Behavioral Sciences; Dr. Susan Heckbert of the Cardiovascular Research Unit, 91探花Department of Epidemiology; Dr. Bessie Young of the Epidemiologic Research Information Center at the Veterans Affairs Puget Sound Health Care System and the 91探花School of Medicine; and Dr. Lisa Williams of the Division of Dermatology, 91探花Department of Medicine.

Grants from the National Institutes of Health supported the research.

Search the Internet to learn about your asthma, high cholesterol or other common disorder, and odds are you’ll be directed to a pharmaceutical company-sponsored Web homepage. There you’ll often find an offer for a free sample or a one-time discount on a top-selling prescription medication.

Is it a good deal? Not according to a study of such direct-to-consumer offers on the Internet by a research team led by Dr. William G. Weppner of the 91探花 (UW) Department of Medicine and the in Boise, Idaho. The results were published in this week’s issue of .

The results showed that the value of such introductory offers is low compared with the retail cost the patient will pay to continue taking the brand-name medication, and in most cases a less-expensive generic equivalent is not available.

The researchers also found that information on efficacy, safety and side effects was de-emphasized, in contrast to the prominent positioning of the free offer. The benefits of the medication were described in a general way, and some included patient testimonials. Quantitative information on the medication’s indications for use, effectiveness and risks was rarely presented. The researchers suggested that further studies would help determine if free offers distract or divert patients from reading risk information.

The United States has permitted advertising prescription drugs directly to consumers for only the past 12 years. Except for New Zealand, no other nation allows it.

The findings on the coupon and voucher pharmaceutical marketing strategy are published in the article “Direct-to-Consumer Offers for Free and Discounted Medications on the Internet: A Content Analysis of 鈥榚-Samples.'” In addition to Weppner, other members of the study team were Dr. Matthew F. Hollon, 91探花clinical associate professor of medicine, Division of General Internal Medicine and a faculty member for the ; Dr. Lisa D. Chew, 91探花assistant professor of Medicine; and Dr. Eric B. Larson, director of in Seattle and 91探花clinical professor of medicine.

The article appears in the journal’s Health-Care Reform section.

“Many of these discounts are aimed at co-pays, which could increase costs to consumers via health insurance premiums,” Weppner said in explaining the relevance to the health-care reform debate on controlling costs.

The paper noted that among the 50 most prescribed medications of 2007 more than half have such Internet offers. The researchers pointed to a prior study of print advertisements: 13 percent of the print ads directed a discount offer to patients.

Patients typically must present the coupon or voucher to a prescribing health-care provider to obtain a prescription, and then give the coupon and prescription to a pharmacist. The researchers cited evidence that clinicians’ decisions to prescribe specific medication may be influenced by patient requests based on direct-to-consumer advertisements and by the availability of samples.

E-samples and discounts for first-time prescriptions may get around efforts by medical schools, hospitals and clinics seeking to prevent the provision of drug-company samples, the researchers suggested. These organizations are trying to curtail the influence of samples on health-care providers’ prescription-writing practices.

The study calculated that the mean yearly retail cost for the medications was $1,559, with a range of $84 to $5,668. The total yearly value of the free sample vouchers for these medications had a mean average of $86, and ranged from $5 to $176. The total yearly value of the discounts had a mean of $75, with a range of $5 to $300.

In other words, the coupon or voucher covered only about 5 percent of the yearly bill. The offers, according to the researchers, also seem to promote medications that are still under patent protection. These expensive brand-name medications have no lower-cost generic competition.

To obtain the offer, 71 percent of the Web sites required the patient to provide personal information such as e-mail or postal address, and medical information such as symptoms, diagnoses, current medical treatments and insurance status.

“Collection of such information may compromise patient privacy if made accessible to unauthorized users,” the researchers noted. “An interesting feature of this marketing strategy is its potential role as a means in which Web users are coerced to provide consumer information that unwittingly drives the content of the Web sites they view. Such a new version of targeted direct-to-consumer advertising could automatically gather information from drug-offer forms, patient searches, previously visited Web sites or even text from e-mail. The strategy would then provide advertising links to Web pages offering discounted or free coupons for drugs.”

The United States Food and Drug Administration (FDA) has distributed draft guidelines on direct-to-consumer prescription drug advertising, which, if adopted, would require a more balanced presentation of risks and benefits. These guidelines do not mention the offering of discounts or free samples to patients.

Ideally, guidelines and practices regarding e-samples would be based on research evaluating their effect on patients’ understanding of risk and benefit information and on treatment decisions, according to Weppner.

“Web-based incentives,” he said, “represent a new and common marketing technique that combines direct-to-consumer advertising with drug samples.”

Through such highly prevalent marketing, they added, “patients and consumers may be poorly served by risk information that is not well-presented, and misled by a discount whose true value is only a small fraction of the true cost for a prescription with no generic alternative.”

This study was supported in part by an institutional Ruth L. Kirchstein Research Service Award, sponsored by the U.S. Health Services and Resources Administration.

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Intimate partner violence (IPV), also called domestic violence, is common and damages women’s physical and mental health significantly, according to a Group Health study reported in two papers in the June issue of the American Journal of Preventive Medicine.

In a random sample of more than 3,400 women members of Group Health Cooperative, nearly half鈥�44 percent鈥攔eported having experienced IPV during their adult lifetime.

“This is an epidemic,” said Dr. Robert S. Thompson, senior investigator, Group Health Center for Health Studies, lead author of one paper. “But it flies under the radar, because of the stigma and shame associated with it 鈥� as well as the fear that many health care providers have of opening what some call a 鈥楶andora’s Box’ of difficult problems that they are unsure how to address.” Thompson is also a 91探花clinical professor of pediatrics and of health services.

This study is the first to find that the more recent a woman’s IPV, and the longer it has gone on, the worse her physical and mental health and social network are likely to be.

“IPV harms women’s physical and mental health even more than do other common conditions, such as back pain and even several forms of cancer,” said Dr. Amy E. Bonomi, research associate at Group Health Center for Health Studies and lead author of the other paper. Compared to women with no IPV, women with recent physical IPV were four times as likely to report symptoms of severe depression, nearly three times as likely to report poor or fair health and more than one additional symptom. They also reported lower social functioning by several measures.

Previous estimates ranged from a quarter to a half of women experiencing IPV during their adult lifetimes, depending on how researchers defined IPV and whom they sampled, with young, low-income women reporting more IPV. Interestingly, this study, which reports a prevalence of nearly one half, involves health-plan enrollees who tend to be older and have higher incomes and more education than average, making it clear that IPV is an equal-opportunity problem.

Bonomi and Thompson found the effects of physical abuse, such as slapping, hitting, kicking, or forced sex, to be stronger than those of nonphysical abuse, such as threats, chronic disparaging remarks, or controlling behavior, alone. But they also found that both physical and nonphysical IPV significantly damage women’s health, and that physical abuse often accompanies nonphysical abuse.

IPV persisted for more than 20 years in 5 percent to 13 percent of the women, with more than one partner perpetrating IPV on 11 percent to 21 percent of them, with these ranges depending on the type of abuse. Prevalence was 15 percent in the last five years, and 8 percent in the last year, for any IPV.

“We are at a point with IPV that seems similar to where we were with cigarette smoking and alcoholism 20 years ago,” said Bonomi. “To prevent IPV from starting and continuing, we need interventions that span individual, community and social levels.” She and Thompson suggest that these interventions should include inquiring routinely about IPV and linking people to appropriate services.

The Agency for Health Research and Quality funded the study. The other authors of the papers about the study are Group Health Center for Health Studies affiliate scientific investigator Dr. Frederick P. Rivara of Harborview Injury Prevention and Research Center and the UW; and Melissa Anderson, Dr. Robert J. Reid, Dr. Jane A. Dimer and Dr. David Carrell of Group Health.