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More information is needed about the relative effectiveness of prophylactic surgery, chemoprevention, and surveillance in reducing breast and ovarian cancer risk in women with an inherited susceptibility mutation. We assessed practical and ethical barriers to conducting randomized clinical trials (RCTs) to compare preventive interventions for breast and ovarian cancer. Eighty-seven at-risk women who attended an education and counseling session about BRCA1/2 testing were asked about their willingness to participate in hypothetical research studies for breast and ovarian cancer risk reduction. In addition, 247 Maryland physicians from five specialties completed a mail survey including a question about their likelihood of recommending RCT participation to an at-risk woman. Nineteen percent of at-risk women reported willingness to participate in a hypothetical RCT for breast cancer risk reduction and 17% for ovarian cancer risk reduction. Women with children and women likely to have a prophylactic mastectomy if found to have a susceptibility mutation were significantly more willing to participate in an RCT. A majority of women would be willing to participate in nonrandomized trials or registries. Fifty-two percent of physicians responded that they would be likely to recommend RCT participation to a woman carrying a breast cancer susceptibility mutation. Oncologists were the most likely to recommend an RCT. Although the results of nonrandomized trials may be difficult to interpret because of such issues as selection bias. Greater feasibility combined with fewer ethical concerns make nonrandomized trials a more viable alternative to randomized trials for evaluation of preventive interventions for breast and ovarian cancer when prophylactic surgery is one of the treatments being evaluated. [ABSTRACT FROM AUTHOR]

PURPOSE/OBJECTIVES: To compare outcomes of pretest education about breast cancer susceptibility testing provided by nurses and genetic counselors. DESIGN: Two-group, post-test only evaluation of an educational intervention. SETTING: A tertiary care hospital. SAMPLE: 87 women who had a first-degree relative with premenopausal breast cancer; six specially-trained providers (four genetic counselors and two nurses). METHODS: Self-administered questionnaire completed immediately following education sessions. MAIN RESEARCH VARIABLES: Subjects' understanding of the limitations of testing, perceived autonomy in decision making, and satisfaction; partnership as perceived by subjects and providers. FINDINGS: After the sessions, 62% of subjects understood the limitations of testing, 98% reported a high degree of perceived autonomy in decision making, 81% were highly satisfied with the session, and 91% reported forming a partnership with their providers. Lower perceived partnership reported by genetic counselors was the only significant difference by provider type. CONCLUSIONS: With training and supervision, nurses and genetic counselors can be equally effective in providing education about genetic testing for breast cancer susceptibility in research settings. Additional research is needed to determine the outcomes of education provided in clinical settings. IMPLICATIONS FOR NURSING PRACTICE: As the demand for education about genetic testing for cancer susceptibility increases, nurses need to be educated and trained to provide this service. [ABSTRACT FROM AUTHOR]

Objective: Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study., Methods: We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients., Results: Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs. 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs. 12.2%; P = .004). The overall refusal rate across both groups was 33.3%., Conclusions: IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period., (Copyright © 2014 by the American Academy of Pediatrics.)

"The Pregnancy and Health Profile" (PHP) is a free prenatal genetic screening and clinical decision support (CDS) software tool for prenatal providers. PHP collects family health history (FHH) during intake and provides point-of-care risk assessment for providers and education for patients. This pilot study evaluated patient and provider responses to PHP and effects of using PHP in practice. PHP was implemented in four clinics. Surveys assessed provider confidence and knowledge and patient and provider satisfaction with PHP. Data on the implementation process were obtained through semi-structured interviews with administrators. Quantitative survey data were analyzed using Chi square test, Fisher's exact test, paired t tests, and multivariate logistic regression. Open-ended survey questions and interviews were analyzed using qualitative thematic analysis. Of the 83% (513/618) of patients that provided feedback, 97% felt PHP was easy to use and 98% easy to understand. Thirty percent (21/71) of participating physicians completed both pre- and post-implementation feedback surveys [13 obstetricians (OBs) and 8 family medicine physicians (FPs)]. Confidence in managing genetic risks significantly improved for OBs on 2/6 measures (p values ≤0.001) but not for FPs. Physician knowledge did not significantly change. Providers reported value in added patient engagement and reported mixed feedback about the CDS report. We identified key steps, resources, and staff support required to implement PHP in a clinical setting. To our knowledge, this study is the first to report on the integration of patient-completed, electronically captured and CDS-enabled FHH software into primary prenatal practice. PHP is acceptable to patients and providers. Key to successful implementation in the future will be customization options and interoperability with electronic health records.

"The Pregnancy and Health Profile," (PHP) is a free genetic risk assessment software tool for primary prenatal providers that collects patient-entered family (FHH), personal, and obstetrical health history, performs risk assessment, and presents the provider with clinical decision support during the prenatal encounter. The tool is freely available for download at www.hughesriskapps.net. We evaluated the implementation of PHP in four geographically diverse clinical sites. Retrospective chart reviews were conducted for patients seen prior to the study period and for patients who used the PHP to collect data on documentation of FHH, discussion of cystic fibrosis (CF) and hemoglobinopathy (HB) carrier screening, and CF and HB interventions (tests, referrals). Five hundred pre-implementation phase and 618 implementation phase charts were reviewed. Documentation of a 3-generation FHH or pedigree improved at three sites; patient race/ethnicity at three sites, father of the baby (FOB) race/ethnicity at all sites, and ancestry for the patient and FOB at three sites (P < 0.001-0001). CF counseling improved for implementation phase patients at one site (8% vs. 48%, P < 0.0001) and CF screening/referrals at two (2% vs. 14%, P < 0.0001; 6% vs. 14%; P = 0.05). Counseling and intervention rates did not increase for HB. This preliminary study suggests that the PHP can improve documentation of FHH, race, and ancestry, as well as the compliance with current CF counseling and intervention guidelines in some prenatal clinics. Future evaluation of the PHP should include testing in a larger number of clinical environments, assessment of additional performance measures, and evaluation of the system's overall clinical utility., (© 2014 Wiley Periodicals, Inc.)

Racial and ethnic disparities in mental health care access in the United States are well documented. Prior studies highlight the importance of individual and community factors such as health insurance coverage, language and cultural barriers, and socioeconomic differences, though these factors fail to explain the extent of measured disparities. A critical factor in mental health care access is a local area's organization and supply of mental health care providers. However, it is unclear how geographic differences in provider organization and supply impact racial/ethnic disparities. The present study is the first analysis of a nationally representative U.S. sample to identify contextual factors (county-level provider organization and supply, as well as socioeconomic characteristics) associated with use of mental health care services and how these factors differ across racial/ethnic groups. Hierarchical logistic models were used to examine racial/ethnic differences in the association of county-level provider organization (health maintenance organization (HMO) penetration) and supply (density of specialty mental health providers and existence of a community mental health center) with any use of mental health services and specialty mental health services. Models controlled for individual- and county-level socio-demographic and mental health characteristics. Increased county-level supply of mental health care providers was significantly associated with greater use of any mental health services and any specialty care, and these positive associations were greater for Latinos and African-Americans compared to non-Latino Whites. Expanding the mental health care workforce holds promise for reducing racial/ethnic disparities in mental health care access. Policymakers should consider that increasing the management of mental health care may not only decrease expenditures, but also provide a potential lever for reducing mental health care disparities between social groups., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

This article describes Medicare beneficiaries' experience with the choice among Medicare drug discount cards and is based primarily on surveys and focus groups with beneficiaries as well as interviews with other stakeholders. Although competition and choice have the potential to reduce cost and enhance quality in the Medicare Program, our findings highlight some of the challenges involved in making choice work in practice. Despite the unique and temporary nature of the drug discount card program, these findings have considerable relevance to the Part D drug benefit and to other Medicare initiatives that rely on choice.

Objective: To identify underlying beliefs and values shaping Americans' opinions about the appropriate use of new reproductive genetic technologies (RGTs), including preimplantation genetic diagnosis, hypothetical genetic modification, and sperm sorting for sex selection., Design: Scenarios with ethical dilemmas presented to 21 focus groups organized by sex, race/ethnicity, religion, age, education, and parental status., Setting: A city in each state: California, Colorado, Massachusetts, Michigan, and Tennessee., Participant(s): One hundred and eighty-one paid volunteers, ages 18 to 68., Intervention(s): None., Main Outcome Measure(s): Beliefs and values that shape participants' opinions about the appropriate use of new RGTs., Result(s): Regardless of demographic characteristics, focus group participants considered six key factors when determining the appropriateness of using RGTs: [1] whether embryos would be destroyed; [2] the nature of the disease or trait being avoided or sought; [3] technological control over "natural" reproduction; [4] the value of suffering, disability, and difference; [5] the importance of having genetically related children; and [6] the kind of future people desire or fear., Conclusion(s): Public opinions about the appropriate use of RGTs are shaped by numerous complementary and conflicting values beyond classic abortion arguments. Clinicians and policy-makers have the opportunity to consider these opinions when creating messages and crafting policy.

Purpose: To assess nongeneticist physicians' knowledge and experience with BRCA1/2 testing., Methods: In 1998, 2250 internists, obstetrician-gynecologists (Ob-Gyns), and oncologists practicing in Pennsylvania, Maryland, Massachusetts, New York, or New Jersey were surveyed., Results: Forty percent responded. Only 13% of internists, 21% of Ob-Gyns, and 40% of oncologists correctly answered all four knowledge questions about genetic aspects of breast cancer and testing for it. Knowledge was associated with discussing or ordering only among oncologists., Conclusion: Despite deficiencies in their knowledge about the genetic aspects of breast cancer, many nongeneticist physicians have discussed testing and some have ordered testing.

The 1997 National Institutes of Health (NIH) Consensus Conference on Cystic Fibrosis (CF) testing recommended that carrier screening be offered to all pregnant women and couples planning a pregnancy. We surveyed 492 Maryland Ob-Gyns before and after the consensus conference to: (1) assess whether obstetricians changed their practice regarding CF carrier testing, and (2) identify the factors associated with changing practice patterns, including awareness of the statement, and knowledge about CF. Fifty-six percent (275) responded to the first mail questionnaire and 107 obstetricians responded to both questionnaires. In 1998, only 18% of respondents to the second questionnaire were familiar with the NIH statement, but 43% reported discussing testing with patients with no family history, a significant increase from 1997, when only 20% reported discussing testing. Less than one-third correctly answered six multiple-choice knowledge questions about CF and carrier testing. In multivariate analysis, knowledge and familiarity with the NIH consensus statement were not associated with beginning to discuss CF carrier testing after the CF conference with their patients without a family history.

Background: A 1995 workforce study conducted by RAND estimated a large current surplus of eye care providers in the United States. Due to data limitations of the RAND study and the outdated optometric workforce information available, the American Optometric Association contracted with Abt Associates to conduct a study to project future workforce requirements for optometry., Methods: We collected extensive data on both the supply (work hours, retirement rates, new entrants) and demand (patient encounters and associated time requirements) of optometrists. These data were collected from a survey using stratified random sampling of 1,100 practicing optometrists and were used to develop workforce projections for optometry through the year 2030. Projections were calculated using a forecasting tool that can be used to derive workforce and training requirements under a range of future scenarios., Results: Workforce projections suggest an excess supply of optometrists is likely over the next 20 years. Over the next five years, approximately 550 optometrists are expected to retire each year, while more than 1,100 optometrists enter practice annually. Patient encounter volume is projected to increase steadily, but the effects of this increase are largely offset by an anticipated decrease in optometrist time requirements for routine eye examinations., Discussion: To reduce the size of the anticipated excess supply, optometry may want to focus on ways that demand can be increased. One way to increase demand is through greater convergence between the actual demand for eye care services and the underlying public health need for eye care.

More information is needed about the relative effectiveness of prophylactic surgery, chemoprevention, and surveillance in reducing breast and ovarian cancer risk in women with an inherited susceptibility mutation. We assessed practical and ethical barriers to conducting randomized clinical trials (RCTs) to compare preventive interventions for breast and ovarian cancer. Eighty-seven at-risk women who attended an education and counseling session about BRCA1/2 testing were asked about their willingness to participate in hypothetical research studies for breast and ovarian cancer risk reduction. In addition, 247 Maryland physicians from five specialties completed a mail survey including a question about their likelihood of recommending RCT participation to an at-risk woman. Nineteen percent of at-risk women reported willingness to participate in a hypothetical RCT for breast cancer risk reduction and 17% for ovarian cancer risk reduction. Women with children and women likely to have a prophylactic mastectomy if found to have a susceptibility mutation were significantly more willing to participate in an RCT. A majority of women would be willing to participate in nonrandomized trials or registries. Fifty-two percent of physicians responded that they would be likely to recommend RCT participation to a woman carrying a breast cancer susceptibility mutation. Oncologists were the most likely to recommend an RCT. Although the results of nonrandomized trials may be difficult to interpret because of such issues as selection bias. Greater feasibility combined with fewer ethical concerns make nonrandomized trials a more viable alternative to randomized trials for evaluation of preventive interventions for breast and ovarian cancer when prophylactic surgery is one of the treatments being evaluated.

Purpose: To learn the extent to which HMOs and academic genetic centers (1) are involved in predictive genetic tests for common, complex disorders and (2) interact with each other., Methods: Surveys of HMO medical directors and directors of U.S. academic genetic centers., Results: In 1996, approximately 28% of HMOs were covering predictive tests for breast and colon cancer, but 75% of all medical directors said their HMO would consider policies regarding predictive testing in the next 5 years. Approximately 80% of directors of academic genetic centers said they provided genetic counseling services for common adult-onset disorders for patients covered by managed care organizations (MCOs), but they ranked the volume of services they provide for pediatric and prenatal indications much higher. Most academic genetic centers (72%) have contracts with MCOs., Conclusion: Although genetic services are being provided by academic genetic centers to patients who are members of managed care organizations, many patients with whom genetic testing for adult onset disorders is discussed may never see a geneticist. Academic genetic centers should educate nongeneticist professionals about the use of tests for common disorders.

Objective: To describe patient-obstetrician communication during the first prenatal visit and its relationship to physician gender and patient satisfaction., Methods: The first prenatal visit of 87 women with 21 obstetricians (11 male and ten female) was audiotaped and analyzed using the Roter Interaction Analysis System. Patient satisfaction was measured by postvisit questionnaire., Results: Communication during first prenatal visits was largely biomedical, with little psychosocial or social discussion. Male physicians conducted longer visits than females (26 minutes versus 21.9 minutes, P < .05) and engaged in more facilitative communication (ie, making sure they were understood and providing direction and orientation) and explicit statements of concern and partnership (z > 1.96, P < .05). Female physicians devoted more communication to agreements, disagreements, and laughter than males (z > 1.96, P < .05). Satisfaction with physicians' emotional responsiveness and informational partnership was related to female physician gender and a variety of task-focused and affective communication variables., Conclusion: Communication and satisfaction between women and obstetricians during initial prenatal visits is related to physician gender and patient satisfaction. Male physicians conducted longer visits but women were more satisfied with female physicians.

Objectives: We offered education, counseling, and family-based BRCA1/2 testing to women at increased risk of breast cancer and assessed (a) their reasons for participating and (b) whether source of recruitment, desire to help research (altruism), and the need to communicate with their affected relative about testing distinguish those who did and those who did not complete each phase of our protocol., Materials and Methods: We sent invitations to 403 women who had completed a questionnaire on BRCA1/2 testing, 178 of whom were considered high risk because they had more than one relative on the same side of the family with early-onset breast cancer., Results: Among the 132 high-risk respondents from the mid-Atlantic states (where testing was offered), 36% (n = 47) were interested in counseling. Those who actually attended counseling were more likely to have some college education, a higher perceived risk of breast cancer, and a greater fear of stigma and were less likely to have a daughter than those who did not attend. The reasons for attending that were rated "very important" were to learn about the test (80%), to have the test (43%), and to help research (38%). High-risk women were eligible for testing only if their affected relative was willing to be tested and tested positive. After the session, 83% intended to ask their affected relative to be tested, but only half of the affected relatives actually came for pretest counseling. The proportion of participants who ultimately involved an affected relative was 2.5 times higher among women from a clinical population (25%) than among those from a registry population (10%); in this latter population, an altruistic desire to help research was a greater motivator for participation than interest in being tested., Conclusions: Source of recruitment influences both motivations to attend education and counseling and actual testing behavior. These results have implications for interpretation of findings from studies in research settings as well as for informed consent and decision-making in the context of family-based testing.

The number of influenza and influenza-related deaths is alarmingly high, yet mean vaccination adherence rates among the high-risk elderly population remain at only 20%. The present study investigates the use of an inexpensive voice-mail system, TeleMinder, as a method of increasing influenza vaccination adherence among a subpopulation of elders identified as low adherers. The first group of older people received no intervention. Group 2 received a voice-mail message informing them of the cost, time, date, and location of an influenza vaccination clinic. Group 3 was exposed to posted and verbal announcements alone. Group 4 both received voice mail and was exposed to posted and verbal announcements. Vaccination adherence levels for groups 1 through 4 were 1.5%, 11.8%, 7.4%, and 37.5%, respectively. Voice mail significantly increased vaccination adherence either alone or in combination with posted and verbal announcements. These findings suggest that voice mail provides an inexpensive means of increasing influenza vaccination rates.