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OBJECTIVES: We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail (arm 3). METHODS: We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire. RESULTS: Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high. CONCLUSIONS: This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions. [ABSTRACT FROM AUTHOR]

The purpose of this study was to assess whether an electronic prompt promoting BMD testing affected the proportion of patients who received BMD and/or bone health medication. Rheumatology providers of patients 40+, on prednisone, with no record of BMD testing in the past 2 years, were targeted with the message: 'This patient is at risk for osteoporosis due to prednisone use. We have no record of a recent Dexa scan.' We also surveyed providers on the prompt's value. The use of prednisone remained stable; BMD testing was quite low in all periods but increased slightly (non-statistically) over time, as did bone health medication use. Providers found the prompt not tailored enough to be clinically meaningful. Electronic prompts seem beneficial in theory; however, putting them into practice has challenges. While the EMR has great potential to improve care, more needs to be done to ensure optimal use. [ABSTRACT FROM AUTHOR]

Objective: To use focus groups to inform a web-based educational intervention for increased fruit and vegetable (FV) consumption.Methods: Twelve groups (participants=137, aged 21-65) were recruited from four geographically diverse health systems. Four groups were stratified by gender and eight by race (white and African American) and gender. Questions included perceptions of healthy eating, factors that encourage or serve as barriers to FV consumption and features preferred for a web-based educational intervention.Results: Though knowledgeable about healthy eating, participants did not know how to achieve or always care about healthy nutritional choices. Motivators for FV consumption included being role models and health concerns. Barriers included: lack of time, expense and FV availability. Website preferences included: visuals, links, tailored materials, menu suggestions, goal setting assistance, printable summaries and built in motivation. The developers incorporated nearly all suggestions.Conclusion: Focus groups provided needs-based tactical strategies for an online, education intervention targeting factors to improve FV consumption.Practice Implications: Focus groups can provide valuable input to inform interventions. Further, web-based programs' abilities to offer information without time or geographic constraints, with capacity for tailoring and tracking progress makes them a valuable addition in the arsenal of efforts to promote healthy behaviors. [ABSTRACT FROM AUTHOR]

Policy makers, researchers, clinicians, and the public are frustrated that research in the health sciences has not resulted in a greater improvement in patient outcomes. Our experience as clinicians and researchers suggests that this frustration could be reduced if health sciences research were directed by 5 broad principles: (1) the needs of patients and populations determine the research agenda; (2) the research agenda addresses contextual and implementation issues, including the development of delivery and accountability systems; (3) the research agenda determines the research methods rather than methods determines the research agenda; (4) researchers and clinicians collaborate to define the research agenda, allocate resources, and implement findings; and (5) the level of funding for implementation research is commensurate with and proportional to the magnitude of the task. To keep the research agenda focused on the task of improving health and to acknowledge that the effort must be seen as more comprehensive than translating or transferring research into practice (TRIP), we suggest that the task be reframed, using the term optimizing practice through research. [ABSTRACT FROM AUTHOR]

Because of recent studies showing strong prevention benefit and acceptable psychosocial outcomes, more women may be considering prophylactic mastectomy. A growing literature shows some positive psychosocial outcomes for women with bilateral prophylactic mastectomy, but less is known about women with contralateral prophylactic mastectomy. Several surveys have shown that a large majority of women with prophylactic mastectomy report satisfaction with their decisions to have the procedure when asked in a quantitative, closed-ended format. We sought to explore the nuances of women's satisfaction with the procedure using a qualitative, open-ended format. We included open-ended questions as part of a mailed survey on psychosocial outcomes of prophylactic mastectomy. The research team coded and analyzed these responses using qualitative methods. We used simple descriptive statistics to compare the demographics of the entire survey sample to those women who answered the open-ended questions; the responses to the open- and closed-ended satisfaction questions, and the responses of women with bilateral and contralateral prophylactic mastectomy. Seventy-one percent of women with prophylactic mastectomy responded to the survey and 48% provided open-ended responses about psychosocial outcomes. Women's open-ended responses regarding psychosocial outcomes could be coded into one of three general categories--positive, negative, and disparate. In the subgroup of women with both open- and closed-ended responses, over 70% of women providing negative and disparate comments to the open-ended question simultaneously indicated satisfaction on a closed-ended question. Negative and disparate open-ended responses were twice as common among women with bilateral prophylactic mastectomy (52%) than women with contralateral prophylactic mastectomy (26%). These findings suggest that even among women who report general satisfaction with their decision to have prophylactic mastectomy via closed-ended survey questions, lingering negative psychosocial outcomes can remain, particularly among women with bilateral prophylactic mastectomy. This dichotomy could be an important factor to discuss in counseling women considering the procedure. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and is the fourth leading cause of death in the United States. It affects dally life functioning and work productivity. Treatment is very expensive. Because COPD can have a profound, disruptive, and disabling impact on those afflicted as well as on the health system providing care, finding optimal ways to manage patients became a priority for our large mid-western collaborative of health care organizations. To this end, a guideline was developed to help clinicians identify, evaluate, and manage COPD. This article provides an overview of the guideline development process and implementation approach as well as key guideline components. Also presented is a step-bystep pharmacologic treatment strategy. This article assists P & T Committees and other committees that oversee their organization's guideline development process in gaining insights into both the guideline development process itself and key aspects for a comprehensive guideline for stable COPD management in particular. [ABSTRACT FROM AUTHOR]

Rotator cuff impingement syndrome and associated rotator cuff tears are commonly encountered shoulder problems. Symptoms include pain, weakness and loss of motion. Causes of impingement include acromioclavicular joint arthritis, calcified coracoacromial ligament, structural abnormalities of the acromion and weakness of the rotator cuff muscles. Conservative treatment (rest, ice packs, nonsteroidal anti-inflammatory drugs and physical therapy) is usually sufficient. Some patients benefit from steroid injection, and a few require surgery. [ABSTRACT FROM AUTHOR]

Objectives: To describe human papillomavirus (HPV) vaccine coverage among adult privately insured women including variation in coverage by race/ethnicity., Methods: This cross-sectional, observational study included women 18-26 years of age with continuous enrollment in a U.S. Midwestern health insurance plan and at least one visit to a plan affiliated practice. Vaccination data came from insurance claims and the electronic medical record. Primary outcomes were: receipt of at least 1 HPV vaccine (HPV1) and completion of the 3-dose HPV vaccine series (HPV3). Coverage was described for the entire cohort and stratified by race/ethnicity. For a subset of women, automated data was compared to personal recall., Results: As of June 2010, among 2546 privately insured women 18-26 years, 72.7% had received their first HPV vaccine and 57.9% completed the 3-dose series. Compared to white women, African American and Asian women had significantly lower coverage for HPV1 and HPV3. There was 94.5% (95% CI: 88.5-100%) agreement between personal recall and claims/EMR for receiving HPV1., Conclusions: In this cohort of privately insured women, a majority received HPV1 and more than half completed the 3-dose vaccine series. Marked disparities in receipt of HPV vaccine by race/ethnicity were observed., (© 2013.)

An increasing number of vaccines are now designated as maternal vaccines, recommended prior to, during, or immediately following pregnancy. The influenza and pertussis (Tdap) vaccines have the potential to improve the health of women and their offspring. Among privately insured women of reproductive age, goals of this study were to describe influenza and Tdap vaccination coverage and to explore variation in coverage by age and race/ethnicity. This cross-sectional, observational study included women 18-44 years of age with continuous enrollment from 1 January 2007-31 March 2011 in a single, Midwestern health insurance plan and at least one visit to a plan affiliated practice. Data on vaccine coverage came from insurance claims, supplemented by electronic medical record data. Primary outcomes were: receipt of Tdap ever, receipt of Tdap or Tetanus vaccination (Td) in the past 10 years, and receipt of influenza vaccination during the 2010-2011 influenza season. Coverage was compared by race/ethnicity. Among 12,657 women with continuous private insurance, 45.5 % had received Tdap ever, 82.5 % had received Td or Tdap in the past 10 years, and 39.8 % received the influenza vaccine in the 2010-2011 season. Marked disparities in influenza vaccination coverage by race/ethnicity were observed, only 30.0 % of African American women received influenza vaccine compared to 40.7 % of white, non-Hispanic women (p < .0001). Among insured women of reproductive age, there is a need for interventions to increase Tdap and influenza vaccination uptake. Further research is needed to understand and address disparities in influenza vaccination coverage in this population.

Immunizations are crucial to the prevention of disease, thus, having an accurate measure of vaccination status for a population is an important guide in targeting prevention efforts. In order to comprehensively assess the validity of self-reported adult vaccination status for the eight most common adult vaccines we conducted a survey of vaccination receipt and compared it to the electronic medical record (EMR), which was used as the criterion standard, in a population of community-dwelling patients in a large healthcare system. In addition, we assessed whether validity varied by demographic factors. The vaccines included: pneumococcal (PPSV), influenza (Flu), tetanus diphtheria (Td), tetanus diphtheria pertussis (Tdap), Human Papilloma Virus (HPV), hepatitis A (HepA), hepatitis B (HepB) and herpes zoster (shingles). Telephone surveys were conducted with 11,760 individuals, ≥18, half with documented receipt of vaccination and half without. We measured sensitivity, specificity, positive and negative predictive value, net bias and over- and under-reporting of vaccination. Variation was found across vaccines, however, sensitivity and specificity did not vary substantially by either age or race/ethnicity. Sensitivity ranged between 63% for HepA to over 90% (tetanus, HPV, shingles and Flu). Hispanics were 2.7 times more likely to claim receipt of vaccination compared to whites. For PPSV and Flu those 65+ had low specificity compared to patients of younger ages while those in the youngest age group had lowest specificity for HepA and HepB. In addition to racial/ethnic differences, over-reporting was more frequent in those retired and those with household income less than $75,000. Accurate information for vaccination surveillance is important to estimate progress toward vaccination coverage goals and ensure appropriate policy decisions and allocation of resources for public health. It was clear from our findings that EMR and self-report do not always agree. Finding approaches to improve both EMR data capture and patient awareness would be beneficial., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objective: Despite evidence indicating therapeutic benefit for adhering to a prescribed regimen, many patients do not take their medications as prescribed. Non-adherence often leads to morbidity and to higher health care costs. The objective of the study was to assess patient characteristics associated with medication adherence across eight diseases., Design: Retrospective data from a repository within an integrated health system was used to identify patients ≥18 years of age with ICD-9-CM codes for primary or secondary diagnoses for any of eight conditions (depression, hypertension, hyperlipidemia, diabetes, asthma or chronic obstructive pulmonary disease, multiple sclerosis, cancer, or osteoporosis). Electronic pharmacy data was then obtained for 128 medications used for treatment., Methods: Medication possession ratios (MPR) were calculated for those with one condition and one drug (n=15,334) and then for the total population having any of the eight diseases (n=31,636). The proportion of patients adherent (MPR ≥80%) was summarized by patient and living-area (census) characteristics. Bivariate associations between drug adherence and patient characteristics (age, sex, race, education, and comorbidity) were tested using contingency tables and chi-square tests. Logistic regression analysis examined predictors of adherence from patient and living area characteristics., Results: Medication adherence for those with one condition was higher in males, Caucasians, older patients, and those living in areas with higher education rates and higher income. In the total population, adherence increased with lower comorbidity and increased number of medications. Substantial variation in adherence was found by condition with the lowest adherence for diabetes (51%) and asthma (33%)., Conclusions: The expectation of high adherence due to a covered pharmacy benefit, and to enhanced medication access did not hold. Differences in medication adherence were found across condition and by patient characteristics. Great room for improvement remains, specifically for diabetes and asthma.

Long-term information needs are increasingly important as more people are diagnosed with cancer and living well beyond initial diagnosis and treatment. Consequently, cancer is joining the ranks of chronic conditions (e.g., asthma, diabetes) for which ongoing, long-term surveillance and management should be the model of care. However, the post-treatment period is fraught with uncertainty for patients and care providers. The "who, what, and when" of follow-up care, in particular, can be complex and confusing. Therefore, survivorship care plans (SCPs) are recommended. The Minnesota Cancer Alliance, a coalition working to improve quality of life for cancer survivors, developed a patient-focused SCP. This user-friendly SCP could be considered for use in patient care--particularly by nurses, who are well suited and positioned to implement SCPs.

The purpose of this study was to obtain genetic counselors' perspectives about the identification of appropriate patients and barriers to referral of high-risk patients for cancer genetic counseling services. Genetic service providers from eight integrated health systems were surveyed. Data analysis included descriptive statistics. Twenty-eight of 40 potential participants responded (70%). Referrals for familial cancer risk assessment overwhelmingly came from providers (89%); only 10% were self-referrals. Use of guidelines to assist providers with referral was reported by 46% of the respondents. Genetic service providers perceived patient barriers to seeking genetic counseling after referral included: risk evaluation viewed as a non-priority (72%), concerns about impact on insurability (52%), distance to appointments (48%), lack of insurance (44%), lack of patient/provider knowledge about the value of genetic counseling (36%), discouragement by family members (28%), and fear (20%). The best approaches suggested by respondents to increase appropriate referrals were attending meetings and giving presentations to oncologists, surgeons, primary care and gynecologists. The genetic service providers reported several barriers to the referral and use of genetic counseling. This finding is consistent with current literature from the providers' perspective. Our survey adds the genetic service providers' perspective and identifies areas of opportunity for further research and intervention as few of the perceived barriers are being addressed through current educational efforts.

Unlabelled: Objectives  To describe the prevalence and characteristics related to indoor tanning use among adults in the United States in the past year., Design: Cross-sectional study., Setting: Health Information National Trends Study, 2005., Participants: The study included 2869 participants who were white and aged 18 to 64 years; a random subset of 821 participants were also asked questions about skin cancer prevention knowledge and attitudes., Main Outcome Measures: The study assessed the prevalence of self-reported use of indoor tanning in the past 12 months and its associations with demographic and lifestyle factors, knowledge, and attitudes., Results: Overall, 18.1% of women and 6.3% of men reported tanning indoors in the past 12 months. Women who were older, were less educated, had lower income, and used sunscreen regularly were less likely to report the behavior, while women residing in the Midwest and the South and who used spray tanning products were more likely to report the behavior. Men who were less likely to report the behavior were older and obese but more likely to report the behavior if they lived in metropolitan areas and used spray tanning products. In an open-response format, only 13.3% of women and 4.2% of men suggested that avoidance of tanning bed use could reduce their risks of skin cancer. Greater skin cancer knowledge and higher perceived risk of skin cancer were inversely associated with the behavior in women., Conclusions: Prevalence and some characteristics associated with indoor tanning use, such as sunscreen use, differed between women and men in the United States. Most adults did not volunteer avoidance of tanning bed use to prevent skin cancer. Clinician-patient communication on risks of indoor tanning may be helpful to reduce indoor tanning use.

Background: The Internet provides us with tools (user metrics or paradata) to evaluate how users interact with online interventions. Analysis of these paradata can lead to design improvements., Objective: The objective was to explore the qualities of online participant engagement in an online intervention. We analyzed the paradata in a randomized controlled trial of alternative versions of an online intervention designed to promote consumption of fruit and vegetables., Methods: Volunteers were randomized to 1 of 3 study arms involving several online sessions. We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of paradata measures of Web pages visited and time spent online with the intervention materials. Multiple regression was used to assess influence of engagement on retention and change in dietary intake., Results: Baseline surveys were completed by 2513 enrolled participants. Of these, 86.3% (n = 2168) completed the follow-up surveys at 3 months, 79.6% (n = 2027) at 6 months, and 79.4% (n = 1995) at 12 months. The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm (P < .01). Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys (odds ratios [OR] = 4.11 and 2.12, respectively, both P values < .001). The breadth measure of engagement was also significantly positively associated with a key study outcome, the mean increase in fruit and vegetable consumption (P < .001)., Conclusions: By exploring participants' exposures to online interventions, paradata are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention. Controlling for intervention arm, greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention, dietary change. This paper demonstrates the utility of paradata capture and analysis for evaluating online health interventions., Trial Registration: NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5u8sSr0Ty).

Purpose: To examine osteoporosis prevention and treatment among home health care (HHC) patients at risk of fragility fracture in a large, Midwestern integrated HHC system., Methods: All patients who received HHC services in 2006 were identified. International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes and pharmaceutical data were examined between January 1, 2004 and December 31, 2005 to determine risk status (high vs average) for fragility fracture. Patients with a documented diagnosis of osteoporosis, osteopenia, previous fragility fracture, stroke, or those taking a glucocorticoid were categorized as high risk. Pharmaceutical data (eg, estrogen, bisphosphonates) were obtained during the same 2-year period to determine treatment status. Descriptive statistics documented the proportion at high risk and treatment status. Inferential statistics tested differences in characteristics (age, gender, race, number of comorbidities) among high-risk patients with and without treatment., Results: 2798 patients were seen in HHC during 2006 and had utilization data available in 2004 and 2005. Of these, 754 were categorized as high risk and 2044 as average risk. Approximately one third (34%) of high-risk patients received osteoporosis medication compared to 4% of average risk (P < .0001). We found no treatment differences based on age. Those with higher comorbidity profiles were less likely to receive treatment (P < .0001)., Conclusion: Only 34% of HHC patients at high risk for fracture received adequate treatment. Patients with more comorbidities were least likely to receive treatment. Since these individuals are receiving medical and nursing care, an opportunity exists to increase treatment rates for those at greatest risk.

Background: Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll., Objective: The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ., Methods: The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment., Results: Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame., Conclusions: Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations., Trial Registration: Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU).

The authors examined the relation between smoking status and fruit and vegetable (FV) consumption among a population-based sample and examined differences in psychosocial factors that may influence diet and inform intervention efforts. The authors recruited adults (N = 2,540) from 5 US health plans to participate in a Web-based dietary intervention trial. At baseline, smokers ate fewer FV servings per day (p < .001) and were less likely to meet the 5 A Day goal (p < .001). Smokers reported lower self-efficacy, overall motivation, and intrinsic motivation for meeting daily FV recommendations. Fewer smokers expected that eating 5 FV servings a day would reduce their risk for diabetes (p = .02) or obesity (p = .008). Smokers are an important target group for dietary intervention. Intervention efforts should attempt to increase smokers' motivation and confidence in their abilities to change their eating patterns and educate them about the health benefits of eating FV.

Objectives: To examine attitudes, experiences, and preferences regarding advance directives (ADs) among adults of all ages., Study Design: Subjects were surveyed regarding end-of-life (EOL) care wishes. The survey included items measuring knowledge, experiences, and attitudes regarding ADs, as well as preferences toward initiation of discussions., Methods: Subjects included a random sample of patients (age range, 20 to >80 years) from a large midwestern managed care organization stratified by age decade. Descriptive statistics were used to summarize variables, and chi2 tests were performed to examine differences by age category., Results: One hundred eighty-seven surveys were completed. The likelihood of having completed an AD increased with age (P <.001). Of those without an AD, 44% reported having talked with someone about their wishes. Many (62%) subjects thought that it was up to them to raise the topic of EOL care. However, 70% of subjects reported that they would be comfortable if their provider initiated discussion. Participants 60 years or older were more likely to report being very comfortable with their provider bringing up the subject compared with those younger than 60 years (60% vs 39%, P = .02). Few differences were found by age., Conclusions: Room for improvement exists for increasing the number of patients who complete an AD or engage in discussion of their wishes. Ways to involve healthcare providers in the process should be explored, as it seems that patients are receptive to physician-initiated discussions of ADs.

Background: The objective of our study was to examine cardiologists' and organizational leaders' interest in clinical trial participation and perceived barriers and facilitators to participation within ten diverse non-profit healthcare delivery systems. Trials play a pivotal role in advancing knowledge about the safety and efficacy of cardiovascular interventions and tests. Although cardiovascular trials successfully enroll patients, recruitment challenges persist. Community-based health systems could be an important source of participants and investigators, but little is known about community cardiologists' experiences with trials., Methods: We interviewed 25 cardiology and administrative leaders and mailed questionnaires to all 280 cardiologists at 10 U.S. healthcare organizations., Results: The survey received a 73% response rate. While 60% of respondents had not participated in any trials in the past year, nearly 75% wanted greater participation. Cardiologists reported positive attitudes toward trial participation; more than half agreed that trials were their first choice of therapy for patients, if available. Almost all leaders described their organizations as valuing research but not necessarily trials. Major barriers to participation were lack of physician time and insufficient skilled research nurses., Conclusions: Cardiologists have considerable interest in trial participation. Major obstacles to increased participation are lack of time and effective infrastructure to support trials. These results suggest that community-based health systems are a rich source for cardiovascular research but additional funding and infrastructure are needed to leverage this resource.

Purpose: To provide information on the prevalence of use of cardiovascular drugs, some of which may have fetotoxic or teratogenic effects, in the outpatient setting among pregnant women in the United States., Methods: A retrospective study was conducted using the automated databases of seven health plans participating in the HMO Research Network Center for Education and Research on Therapeutics (CERT). Women who delivered an infant from 1 January 2001 to 31 December 2005 were identified. Cardiovascular drug use was evaluated assuming a gestational duration of 270 days., Results: During the period 2001 through 2005, 118,935 deliveries were identified that met the criteria for study; 3.1% of women (N = 3672) were dispensed an antihypertensive medication and 0.12% of women (N = 146) were dispensed an antihyperlipidemic medication at any time during pregnancy. The most common antihypertensive drugs dispensed during pregnancy were nifedipine (1219 deliveries; 1.0%), methyldopa (961 deliveries; 0.8%), atenolol (593 deliveries; 0.5%), and labetalol (576 deliveries; 0.5%). Overall, 134 women (0.11%) received an angiotensin converting enzyme (ACE) inhibitor and 7 women (0.006%) received an angiotensin II receptor blocker (ARB) during pregnancy. Statins were the most commonly dispensed antihyperlipidemic drugs (71 deliveries; 0.06%)., Conclusions: The prevalence of use of cardiovascular drugs that are suspected to be fetotoxic or teratogenic (ACE inhibitors, ARBs, and statins) was low in this cohort of pregnant women. Differing patterns of use across health plans suggests that further research is needed to evaluate the potential differential effects of cardiovascular drugs to assist prescribers and patients in making informed treatment decisions., (Copyright 2008 John Wiley & Sons, Ltd.)

Objective: This study was undertaken to provide information on the prevalence of use of antidepressant drugs among pregnant women in the United States., Study Design: A retrospective study was conducted using the automated databases of 7 health plans. Women who delivered an infant in a hospital were identified. Antidepressant drug use was evaluated assuming a gestational duration of 270 days., Results: Among the 118,935 deliveries occurring from 2001-2005, 6.6% of women were dispensed an antidepressant during pregnancy. Antidepressant drug use increased from 2.0% in 1996 to 7.6% of deliveries in 2004 and 2005. Selective serotonin reuptake inhibitor use increased from 1.5% in 1996 to 6.4% in 2004 and 6.2% in 2005., Conclusion: Our finding that nearly 8% of pregnant women were prescribed antidepressants drugs during the years 2004 and 2005 highlights the importance of understanding the effects of these medications on the developing fetus and on the pregnant woman.

Purpose: In order to determine whether new treatments for advanced breast cancer resulted in improved survival, we analyzed treatment and survival trends in 232 women with metastatic breast cancer treated in the Minneapolis/St. Paul metropolitan area between 1990 and 2003., Patients and Methods: Subjects were identified from area hospital tumor registries and the Minnesota Department of Health. Data on demographics, estrogen receptor status, location of metastases, and treatment were obtained from hospital tumor registries and medical records., Results: A total of 95 patients were diagnosed between 1990 and 1995, and 137 were diagnosed between 1996 and 2003. Overall, there was no difference in survival for women treated between 1990 and 1995 and those treated from 1996 to 2003 (13 months vs. 19 months; P = .38). Chemotherapy recipients in the latter cohort had significantly longer survival than chemotherapy recipients in the earlier cohort (13 months vs. 29 months; P = .03). There were no differences found in survival between cohorts for women receiving hormonal therapy only (18 months vs. 16 months; P = .81)., Conclusion: We conclude that newer chemotherapeutic agents have had an impact on survival in women with metastatic breast cancer. Newer hormonal agents did not have the same impact on survival in our study.

Women dying of ovarian cancer vary considerably in their complications and in the types of health care they receive. The objective of this study was to describe the complications of ovarian cancer, other than pain, and their treatment at the end of life. This study used a cohort of 421 enrollees in three nonprofit managed-care organizations who died with ovarian cancer during 1995-2000. Data were collected from abstraction of paper and electronic medical records. Proportions of women experiencing complications and undergoing treatments were calculated. Logistic regression was used to evaluate the association of patient characteristics with the probability of receiving an intervention for complications. The most common complications recorded in the medical record were fatigue or weakness (75%), nausea or vomiting (71%), constipation (49%), edema of the extremities (44%), and anemia (34%). The prevalence of major complications was as follows: ascites, 28%; bowel obstruction, 12%; pleural effusion, 10%; bladder obstruction, 3%; and disordered nutrition that required support with parenteral nutrition, 9%. Patients may not always have received interventions for major complications; for example, pleural effusion apparently was left untreated in almost half of the women with this problem. After adjustment, women who died at younger ages were more likely to receive an intervention, compared to older women (odds ratio for each decade of age, 0.71, 95% confidence interval=0.53, 0.94, P for trend=0.02). The study, which preceded the establishment of palliative care programs, suggests that care given to ovarian cancer patients at the end of life may be inadequate.

Although prophylactic mastectomy significantly reduces the incidence and recurrence of breast cancer, little is known about women's information needs before the procedure. We surveyed 967 women, from 6 healthcare systems, with bilateral or contralateral prophylactic mastectomy performed between 1979 and 1999. There were 2 open-ended questions: "What one thing do you wish you had known before your prophylactic mastectomy" and "Is there anything else you would like to share with us?" Three researchers categorized responses, and informational needs were ascertained. Seventy-one percent (684 women) responded, of which 81% answered one or both open-ended questions. There were 386 comments (made by 293 women) that related to information needs; 79% of women had bilateral prophylactic mastectomy and 58% had contralateral prophylactic mastectomy. Most concerns (69%) were related to reconstruction: the longevity; look and feel of implants, pain, numbness, scarring, and reconstruction options. Many women wished they had seen photographs to better prepare them for the final result. Our findings suggest that information needs of many women undergoing prophylactic mastectomy, particularly those selecting bilateral prophylactic mastectomy, have not been sufficiently addressed. Clinicians and health educators should be aware of patient needs and must counsel women accordingly.

Goals of Work: We investigated the effects of social support in the last 6 months of life for women who died of ovarian cancer., Materials and Methods: The study population included women enrolled in one of three Managed Care Organizations who died of ovarian cancer (1995-2000). Information was collected on demographics, living environment, presence of escorts to oncology encounters, comorbidities, medications, outpatient and inpatient encounters, and referrals to home health and hospice. Two characteristics of social support were examined: living with others and being escorted to one or more oncology visits., Results: Of 421 subjects, both aspects of social support were known for 345 (82%). Of these, 227 (66%) lived with others and were escorted, 33 (10%) lived with others but were never escorted, 59 (17%) lived alone but were escorted, and 26 (8%) lived alone and never were accompanied. Women living alone were less likely to be taking a psychotropic medication (57% vs 70%, p = 0.021) and were somewhat less likely to receive hospice referral (42% vs 53%, p = 0.054). Women who were never escorted had fewer outpatient encounters (12.60 vs 15.77, p = 0.033) and were less likely to be referred to home health (18% vs 30%, p = 0.046)., Conclusions: This study indicates that social support has some beneficial effects on receipt of personal health services. Friends and family may act as proponents for the patient in obtaining services. Health care professionals should be encouraged to assess the cancer patient's social situation and identify areas where help may be needed.

Objective: A survey was conducted to determine current provider behaviors and concerns related to menopause management., Design: All gynecology, internal medicine, and family medicine providers (both physicians and nurse practitioners) within a large Midwestern integrated health system were surveyed about current approaches to menopause management, frequency and reasons for hormone therapy (HT) use, approaches to HT discontinuation, treatments for symptom control, bone mineral density testing, and concerns related to menopause management. Descriptive statistics and chi-square tests were performed to examine frequencies and differences based on gender, specialty, and years in practice., Results: Overall the response rate was 58% with providers from owned clinics, with female providers being the most likely to respond (P < 0.001). Changes in menopause management included using lower dose hormones (74%), encouraging use for shorter time periods (73%), and using different modes of delivery (21%). Most providers (89%) initiate HT use in symptomatic patients, and only 12% initiate use to prevent symptoms. Patients were most likely to discuss HT with gynecologists (78% gynecologists vs 64% family medicine providers and 48% internal medicine providers, P = 0.015). Nearly two thirds of providers (64%) claimed to order bone mineral density testing frequently. Providers' concerns related to information on symptom management, alternative and over-the-counter medications, the risk/benefits of medications, patients' sexual concerns, and maintaining bone health., Conclusions: We found that providers were responsive to current literature, shifting the agents and dosages they prescribe. Still they are faced with women reporting symptoms that interfere with their ability to function optimally and must continue to help women maintain healthy bones.

Background: Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (approximately 94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity., Objective: To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity., Design: Retrospective cohort study., Subjects: Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484)., Measurements: Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered "average-risk" if they had neither a family history of breast cancer nor a prior breast biopsy and "increased-risk" otherwise., Results: Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8-99.7%] and 97.1% (95% CI: 95.7-98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7-76.5%) and 57.1% (95% CI: 51.1-63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10-0.46)., Conclusions: Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.

Background: Bilateral prophylactic mastectomy in women with increased breast cancer risk dramatically reduces breast cancer occurrence but little is known about psychosocial outcomes., Methods: To examine long-term quality of life after bilateral prophylactic mastectomy, we mailed surveys to 195 women who had the procedure from 1979 to 1999 and to a random sample of 117 women at increased breast cancer risk who did not have the procedure. Measures were modeled on or drawn directly from validated instruments designed to assess quality of life, body image, sexuality, breast cancer concerns, depression, health perception, and demographic characteristics. We used logistic regression to examine associations between quality of life and other domains., Results: The response rate was 58%, with 106 women with and 62 women without prophylactic mastectomy returning complete surveys. Among women who underwent bilateral prophylactic mastectomy, 84% were satisfied with their decision to have the procedure; 61% reported high contentment with quality of life compared with an identical 61% of women who did not have the procedure (P = 1.0). Among all subjects, diminished contentment with quality of life was not associated with bilateral prophylactic mastectomy but with dissatisfaction with sex life (adjusted ratio [OR] = 2.5, 95% confidence interval [CI] = 1.0-6.2), possible depression (CES-D > 16, OR = 4.9, CI = 2.0-11.8), and poor or fair general health perception (OR = 8.3, 95% CI = 2.4-29.0)., Conclusions: The majority of women reported satisfaction with bilateral prophylactic mastectomy and experienced psychosocial outcomes similar to women with similarly elevated breast cancer risk who did not undergo prophylactic mastectomy. Bilateral prophylactic mastectomy appears to neither positively nor negatively impact long-term psychosocial outcomes.

Previous studies indicate that the symptoms of many dying cancer patients are undertreated and many suffer unnecessary pain. We obtained data retrospectively from three large health maintenance organizations, and examined the analgesic drug therapies received in the last six months of life by women who died of ovarian cancer between 1995 and 2000. Subjects were identified through cancer registries and administrative data. Outpatient medications used during the final six months of life were obtained from pharmacy databases. Pain information was obtained from medical charts. We categorized each medication based on the World Health Organization classification for pain management (mild, moderate, or intense). Of the 421 women, only 64 (15%) had no mention of pain in their charts. The use of medications typically prescribed for moderate to severe pain ("high intensity" drugs) increased as women approached death. At 5-6 months before death, 55% of women were either on no pain medication or medication generally used for mild pain; only 9% were using the highest intensity regimen. The percentage on the highest intensity regimen (drugs generally used for severe pain) increased to 22% at 3-4 months before death and 54% at 1-2 months. Older women (70 or older) were less likely to be prescribed the highest intensity medication than those under age 70 (44% vs. 70%, P<0.001). No differences were found in the use of the high intensity drugs by race, marital status, year of diagnosis, stage of disease, or comorbidity. Our finding that only 54% of women with pain were given high intensity medication near death indicates room for improvement in the care of ovarian cancer patients at the end of life.

Background: Improvements in cancer detection and treatment have resulted in increasing numbers of breast cancer survivors. Information regarding the use of mammography by breast cancer survivors is limited., Methods: The use of surveillance mammography was examined over a 5-year period in a retrospective cohort of women age>or=55 years who were diagnosed with incident primary breast cancer (1996-1997) while enrolled in 1 of 4 geographically diverse integrated health systems., Results: Of the 797 women included in the study, 80% (n=636) underwent mammograms during the first year after treatment for breast cancer. The percentage of women having mammograms during each yearly period decreased significantly over time. In multivariable analyses, older women with comorbid illnesses or those with late-stage disease were less likely to undergo mammograms, whereas those who underwent breast-conserving therapy (adjusted odds ratio [OR] of 1.38 [95% confidence interval (95% CI), 1.09-1.75]) were more likely to have mammograms. Women who had outpatient visits with a gynecologist (adjusted OR of 3.49 [95% CI, 2.55-4.79]), or a primary care physician (adjusted OR of 2.21 [95% CI, 1.73-2.82]) during the year were more likely to undergo mammograms in that year., Conclusions: The use of mammography among breast cancer survivors declines over time. Efforts are needed to increase awareness among healthcare providers and breast cancer survivors of the value of follow-up mammography. The current findings highlight the importance of maintaining ongoing contact with primary care physicians and gynecologists., (Copyright (c) 2006 American Cancer Society.)

Objective: This study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey., Study Design and Setting: We utilized a cross-sectional mailed survey to gather information on long-term psychosocial outcomes of prophylactic mastectomy among women at six health maintenance organizations, all of which are part of the Cancer Research Network. In the context of this collaborative study, we characterized the impact of the different sites' IRB review processes on the study protocol and participation., Results: IRB review resulted in site differences in physician consent prior to participant contact, invitation letter content and signatories, and incentive type. The review process required two to eight modifications beyond the initial application and resulted in unanticipated delays and costs., Conclusion: Site-to-site variability in IRB requirements may adversely impact scientific rigor and delay implementation of collaborative studies, especially when not considered in project planning. IRB review is an essential aspect of research but one that can present substantial challenges for multicenter studies.

Purpose: To understand psychosocial outcomes after prophylactic removal of the contralateral breast in women with unilateral breast cancer., Methods: We mailed surveys to women with contralateral prophylactic mastectomy after breast cancer diagnosis between 1979 and 1999 at six health care delivery systems, and to a smaller random sample of women with breast cancer without the procedure. Measures were modeled on instruments developed to assess contentment with quality of life, body image, sexual satisfaction, breast cancer concern, depression, and health perception. We examined associations between quality of life and the other domains using logistic regression., Results: The response rate was 72.6%. Among 519 women who underwent contralateral prophylactic mastectomy, 86.5% were satisfied with their decision; 76.3% reported high contentment with quality of life compared with 75.4% of 61 women who did not undergo the procedure (P = .88). Among all case subjects, less contentment with quality of life was not associated with contralateral prophylactic mastectomy or demographic characteristics, but was associated with poor or fair general health perception (odds ratio [OR], 7.0; 95% CI, 3.4 to 14.1); possible depression (OR, 5.4; 95% CI, 3.1 to 9.2); dissatisfaction with appearance when dressed (OR, 3.5; 95% CI, 2.0 to 6.0); self-consciousness about appearance (OR, 2.0; 95% CI, 1.1 to 3.7); and avoiding thoughts about breast cancer (modest: OR, 2.2; 95% CI, 1.1 to 4.5; highest: OR, 1.7; 95% CI, 0.9 to 3.2)., Conclusion: Most women undergoing contralateral prophylactic mastectomy report satisfaction with their decision and experience psychosocial outcomes similar to breast cancer survivors without the procedure.

Background: Blood pressure (BP) is controlled to recommended goal in less than one-third of people with hypertension. There has been little recent research on physician beliefs and practices with regard to the treatment of hypertension., Methods: In late 1999, we surveyed 104 primary care physicians in the 18 owned clinics of a large staff model, non-profit health maintenance organization. The survey included questions about demographics, BP treatment goals for patients with uncomplicated hypertension, and beliefs about hypertension., Results: The reported systolic BP treatment goal was < or =140 mm Hg for 97% and the diastolic BP goal was < or =90 mm Hg for 100%. The systolic BP goal for patients with isolated systolic hypertension was < or =140 mm Hg for 82%, but 34% stated that they would treat to a different goal depending on the diastolic BP. The proportions of physicians who would intensify treatment for BP of 140/90 mm Hg, 150/95 mm Hg, 165/75 mm Hg, and 165/65 mm Hg were 64%, 97%, 89% and 77%, respectively. Although 93% believed that medication was necessary to control BP in most cases, a majority (55%) agreed with the statement that BP could be controlled in most patients with only one drug. Although 42% reported that they often had to change drugs because of side effects, only 16% believed that it was time-consuming to find a well-tolerated drug regimen., Conclusions: In this setting, primary care physicians' self-reported practices were in good agreement with national guidelines put forth in the late 1990s, and their beliefs were favorable to therapy. Our data point to a need for interventions to emphasize that combination drug therapy is frequently required to achieve BP control, and that more aggressive intervention is often warranted for isolated systolic hypertension.

Objective: To determine the sensitivity and positive predictive value (PPV) of computerized diagnostic data from health maintenance organizations (HMOs) in identifying incident breast cancer cases., Study Design: An HMO without a cancer registry developed an algorithm identifying incident breast cancer cases using computerized diagnostic codes. Two other HMO sites with Surveillance, Epidemiology, and End Results (SEER) registries duplicated this case-identification approach. Using the SEER registries as the criterion standard, we determined the sensitivity and PPV of the computerized data., Methods: Data were collected from HMO computerized data-bases between January 1, 1996, and December 31, 1999. Surveillance, Epidemiology, and End Results data were also used., Results: The overall sensitivity of the HMO databases was between 0.92 (95% confidence interval [CI], 0.91-0.96) and 0.99 (95% CI, 0.98-0.99). Sensitivity was high (range, 0.94-0.98), for the first 3 (of 4) years, dropping slightly (range, 0.81-0.94) in the last year. The overall PPV ranged from 0.34 (95% CI, 0.32-0.35) to 0.44 (95% CI, 0.42-0.46). Positive predictive value rose sharply (range, 0.18-0.20) after the first year to 0.83 and 0.92 in the last year because prevalent cases were excluded. Review of a random sample of 50 cases identified in the computerized data-bases but not by SEER data indicated that, while SEER usually identified the cases, the registry did not associate every case with the health plan., Conclusions: Health maintenance organization computerized databases were highly sensitive for identifying incident breast cancer cases, but PPV was low in the initial year because the systems did not differentiate between prevalent and incident cases. Health maintenance organizations depending solely on SEER data for cancer case identification will miss a small percentage of cases.

Purpose: We hypothesize that elevated charges among former smokers reflect differential cessation of sicker individuals. We ascertained the relationship between prior health care charges and time to smoking cessation., Design: Prospective, observational study using panel survey data and administrative health plan records., Setting: A large managed care organization in Minnesota., Subjects: A stratified random sample of 8000 health plan members 40 years and older, yielding 611 current smokers at baseline., Measures: Smoking cessation measured via self-report survey. Health care charges, mortality, and disenrollment data derived from automated health plan databases., Results: Among smoking adults without chronic disease diagnoses at baseline, a first attempt at quitting smoking was positively associated with the presence of any inpatient charges (relative risk [RR], 1.9; p < .05) or any emergency department or urgent care charges (RR, 1.4; p < .10). We also observed positive associations between total charges and ambulatory charges in the top textile (RR, 1.5 and 1.6, respectively; p < .05) with a first attempt at quitting smoking, further suggesting graded relationships. Among smoking adults with one or more of four chronic disease diagnoses at baseline, being in the top two tertiles of total charges or ambulatory care charges was predictive of a subsequent attempt at quitting smoking., Conclusions: Higher health care charges, particularly from ambulatory (primary care clinic) settings, predicted smoking cessation among both individuals with and without chronic diseases. These charges may be proxies for other factors, such as smoking-related symptoms or physician advice or messaging regarding smoking cessation.

Objective: To assess 2 established methods of identifying children with special health care needs (CSHCN) within a health plan population for intensified service coordination., Methods: The tools tested were the Questionnaire for Identifying Children With Chronic Conditions (QuICCC) and the Clinical Risk Grouper (CRG) software. The QuICCC was administered by telephone to the parents of 517 children. The CRG software tool was then applied to the health plan database. The accuracy of identifying the target population was assessed by a single trained reviewer by comparison with the comprehensive medical record., Results: According to the QuICCC, 37.1% of the parents surveyed had CSHCN. According to the CRG, 11% of the health plan's pediatric population was categorized as CSHCN. The medical record review agreed with overall QuICCC findings in 53% to 61% of cases and overall CRG findings in 66% to 73% of cases., Conclusions: Administering the QuICCC was a time- and labor-intensive endeavor with a relatively low overall level of sensitivity. The CRG was less labor intensive with slightly higher sensitivity. Identifying the target population in an effective and efficient manner remains a challenge for health plans.

Objectives: To assess attitudes of physicians, clinic administrators, and patients within a health maintenance organization (HMO) toward using financial incentives to improve the control of hypertension., Study Design: Descriptive study of attitudes toward use of financial incentives paid to physicians or to clinic systems., Methods: Data were collected through physician survey (n = 104), interviews with clinic administrators (n = 24), and patient focus groups (n = 3) during the winter of 1999 and the spring of 2000. Analyses included both qualitative and quantitative approaches., Results: Most physicians (80%) supported additional funding to clinics to create systems to improve hypertension care. However, less than half supported direct payment to either groups of physicians (38%) or individual physicians (24%). Sixty-four percent of clinic administrators supported incentive payments to clinics to improve quality of care, whereas only 42% favored incentives to physicians. Patients had a uniformly favorable view of incentives paid to clinics, but were strongly opposed to direct physician incentives. Written feedback was supported by both clinic administrators (54%) and physicians (74%)., Conclusions: In this nonprofit HMO, none of the stakeholder groups supported direct incentive payments to physicians to improve hypertension control. Trials of financial incentives within managed care organizations should include study arms with clinic-based incentives. Further study is needed to determine if incentives to clinics, which appear to be acceptable, can actually improve blood pressure control.

Objectives: To assess the separate effects of depressive symptoms and antidepressant treatment on healthcare utilization and cost., Setting: Social Health Maintenance Organization (HMO) at HealthPartners in Minnesota., Participants: Geriatric Social HMO enrollees were screened for depressive symptoms using the 30-item Geriatric Depression Scale. A stratified sample was created, composed of geriatric enrollees with depressive symptoms, with antidepressant prescriptions, or with neither (n = 516)., Design: Regression analyses were conducted with separate equations for utilization and charge outcome variables, both outpatient and inpatient (log-transformed). The Charlson Comorbidity Index, age, and gender served as covariates., Measurement: Depressive symptoms were identified through the Diagnostic Interview Schedule. Antidepressant treatment was determined from the HMO pharmacy database., Results: Having depressive symptoms was associated with a 19 increase in the number of outpatient encounters and a 30 increase in total outpatient charges. Antidepressant treatment was associated with a 32 increase in total outpatient charges but was not significantly associated with number of outpatient encounters. Depressive symptoms and antidepressant therapy were not significantly associated with inpatient utilization or charges., Conclusion: This study found that patients with depressive symptoms generated more outpatient health care and higher charges but not necessarily more inpatient care. Our findings suggest that programs targeted to geriatric patients whose depression is comorbid with other chronic medical conditions might be cost-effective and particularly appropriate for geriatric care.