Healthcare Predictors of Information Dissemination About Genetic Risks.

OBJECTIVES: Despite the benefits of genetic counseling and testing (GCT), utilization is particularly low among African American (AA) women who exhibit breast cancer features that are common in BRCA-associated cancer. Underutilization is especially problematic for AA women who are more likely to die from breast cancer than women from any other race or ethnicity. Due to medical mistrust, fear, and stigma that can be associated with genetic services among racial/ethnic minorities, reliance on trusted social networks may be an impactful strategy to increase dissemination of knowledge about hereditary cancer risk. Informed by the social cognitive theory, the purpose of this study is to determine: 1) which AA patients diagnosed with breast cancer and with identified hereditary risk are sharing information about hereditary risk with their networks; 2) the nature of the information dissemination; and 3) if personal GCT experiences is associated with dissemination of information about hereditary risk. METHODS: Among consented participants (n = 100) that completed an interview administered using a 202-item questionnaire consisting of open- and closed-ended questions, 62 patients were identified to be at higher risk for breast cancer. Descriptive statistics, bivariable chi-square, Pearson's exact tests, and regression analyses were conducted to examine differences in characteristics between high-risk participants who disseminated hereditary risk information and participants who did not. RESULTS: Among high-risk participants, 25 (40%) indicated they had disseminated information about hereditary risk to at least one member in their family/friend network and 37 (60%) had not. Receipt of both provider recommendations and receipt of GCT services was associated with greater odds of disseminating information about hereditary risk with networks, OR = 4.53, 95%CI [1.33, 15.50], p = .02. CONCLUSION: Interventions that increase self-efficacy gained through additional personalized knowledge and experience gained through provider recommendations and by undergoing GCT may facilitate information dissemination among social/familial networks.

Longitudinal follow-up after telephone disclosure in the randomized COGENT study.

PURPOSE: To better understand the longitudinal risks and benefits of telephone disclosure of genetic test results in the era of multigene panel testing. METHODS: Adults who were proceeding with germline cancer genetic testing were randomized to telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD) (i.e., usual care) of test results. All participants who received TD were recommended to return to meet with a physician to discuss medical management recommendations. RESULTS: Four hundred seventy-three participants were randomized to TD and 497 to IPD. There were no differences between arms for any cognitive, affective, or behavioral outcomes at 6 and 12 months. Only 50% of participants in the TD arm returned for the medical follow-up appointment. Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002). Mammography was lower at 12 months among those who had TD and did not return for medical follow-up (70%) compared with those who had TD and returned (86%) and those who had IPD (87%, adjusted p < 0.01). CONCLUSION: Telephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.

Preferences for in-person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study.

Telephone disclosure of cancer genetic test results is noninferior to in-person disclosure. However, how patients who prefer in-person communication of results differ from those who agree to telephone disclosure is unclear but important when considering delivery models for genetic medicine. Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone to in-person disclosure of genetic test results. We evaluated preferences for in-person disclosure, factors associated with this preference and outcomes compared to those who agreed to randomization. Among 1178 enrolled patients, 208 (18%) declined randomization, largely given a preference for in-person disclosure. These patients were more likely to be older (P = 0.007) and to have had multigene panel testing (P < 0.001). General anxiety (P = 0.007), state anxiety (P = 0.008), depression (P = 0.011), cancer-specific distress (P = 0.021) and uncertainty (P = 0.03) were higher after pretest counseling. After disclosure of results, they also had higher general anxiety (P = 0.003), depression (P = 0.002) and cancer-specific distress (P = 0.043). While telephone disclosure is a reasonable alternative to in-person disclosure in most patients, some patients have a strong preference for in-person communication. Patient age, distress and complexity of testing are important factors to consider and requests for in-person disclosure should be honored when possible.

Development and Validation of the Spanish Numeracy Understanding in Medicine Instrument.

BACKGROUND: The Spanish-speaking population in the U.S. is large and growing and is known to have lower health literacy than the English-speaking population. Less is known about the health numeracy of this population due to a lack of health numeracy measures in Spanish. OBJECTIVE: we aimed to develop and validate a short and easy to use measure of health numeracy for Spanish-speaking adults: the Spanish Numeracy Understanding in Medicine Instrument (Spanish-NUMi). DESIGN: Items were generated based on qualitative studies in English- and Spanish-speaking adults and translated into Spanish using a group translation and consensus process. Candidate items for the Spanish NUMi were selected from an eight-item validated English Short NUMi. Differential Item Functioning (DIF) was conducted to evaluate equivalence between English and Spanish items. Cronbach's alpha was computed as a measure of reliability and a Pearson's correlation was used to evaluate the association between test scores and the Spanish Test of Functional Health Literacy (S-TOFHLA) and education level. PARTICIPANTS: Two-hundred and thirty-two Spanish-speaking Chicago residents were included in the study. KEY RESULTS: The study population was diverse in age, gender, and level of education and 70 % reported Mexico as their country of origin. Two items of the English eight-item Short NUMi demonstrated DIF and were dropped. The resulting six-item test had a Cronbach's alpha of 0.72, a range of difficulty using classical test statistics (percent correct: 0.48 to 0.86), and adequate discrimination (item-total score correlation: 0.34-0.49). Scores were positively correlated with print literacy as measured by the S- TOFHLA (r = 0.67; p < 0.001) and varied as predicted across grade level; mean scores for up to eighth grade, ninth through twelfth grade, and some college experience or more, respectively, were 2.48 (SD ± 1.64), 4.15 (SD ± 1.45), and 4.82 (SD ± 0.37). CONCLUSIONS: The Spanish NUMi is a reliable and valid measure of important numerical concepts used in communicating health information.

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

PURPOSE: Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. METHODS: Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. RESULTS: In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. CONCLUSION: A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

Health Literacy and Patient-Reported Outcomes: A Cross-Sectional Study of Underserved English- and Spanish-Speaking Patients With Type 2 Diabetes.

This study examined associations between patient characteristics, health behaviors, and health outcomes and explored the role of health literacy as a potential mediator of outcomes. English- and Spanish-speaking adults with Type 2 diabetes used a bilingual multimedia touchscreen to complete questionnaires. The behavioral model for vulnerable populations guided multivariable regression and mediation testing. Dependent variables were diabetes self-care, health status, and satisfaction with communication. Independent variables included sociodemographic and clinical characteristics, health literacy, health beliefs, and self-efficacy. Spanish speakers had lower health literacy and poorer physical, mental, and overall health compared to English speakers. Higher health literacy was associated with less social support for diet, fewer diet and medication barriers, younger age, higher diabetes knowledge, and talking with health care professionals to get diabetes information. In contrast to expectations, health literacy was not associated with diabetes self-care, health status, or satisfaction with communication, and it did not mediate the effects of other factors on these outcomes. Diabetes self-efficacy was significantly associated with health behaviors and outcomes. The association between Spanish language preference and poorer health was not mediated by this group's lower health literacy. Increasing health-related self-efficacy might be an important clinical strategy for improving outcomes in underserved patients with Type 2 diabetes.

Idiopathic granulomatous mastitis--a prospective study of 49 women and treatment outcomes with steroid therapy.

Idiopathic granulomatous mastitis (IGM) is an infrequently reported benign breast disease of unknown etiology. Surgical treatment has been widely advocated but can be disfiguring. We describe demographic and clinico-pathologic features of women with IGM in a safety net hospital, and evaluate steroid therapy as a breast-conserving modality of treatment. We also examine a possible ethnic predominance in Hispanic women. We conducted an observational prospective cohort study of all women with biopsy-proven granulomatous mastitis in the breast clinics of an urban safety net public hospital from 2006 to 2010. Demographic, ethnic and clinical data, treatment history, and response to treatment were collected. Patients were followed up prospectively to determine the type of treatment prescribed, complete resolution of disease, and median time to resolution. A nested case-control study was conducted to examine Hispanic prevalence using chi-square statistic. The mean age was 35 years. 80% were Hispanic. 80% presented with a painful breast mass. 59% initially received antibiotics with incomplete resolution. 90% women were prescribed oral steroids, 3% underwent surgical treatment, and 6% remained under observation with spontaneous resolution. Of those who received steroid, 80% had complete resolution of disease with a median time to complete resolution of 159 days (IQR 120-241 days). Ethnicity data in a nested case-control study revealed that women in the IGM group were more likely to be Hispanic than in the control group with an odds ratio of 3 (95% CI 1.42-6.24, p-value 0.0032). IGM is a benign but locally aggressive breast disease. Treatment with steroids is an effective breast-conserving option. Predominance in Hispanic women of childbearing age suggests a common genetic, environmental, immunologic, or infectious etiology and warrants further study with a multi-disciplinary approach.

Development and validation of the numeracy understanding in Medicine Instrument short form.

Health numeracy can be defined as the ability to understand and use numeric information and quantitative concepts in the context of health. The authors previously reported the development of the Numeracy Understanding in Medicine Instrument (NUMi), a 20-item test developed using item response theory. The authors now report the development and validation of a short form of the NUMi. Item statistics were used to identify a subset of 8 items representing a range of difficulty and content areas. Internal reliability was evaluated with Cronbach's alpha. Divergent and convergent validity was assessed by comparing scores of the S-NUMI with existing measures of education, print and numeric health literacy, mathematic achievement, cognitive reasoning, and the original NUMi. The 8-item scale had adequate reliability (α=.72) and was strongly correlated to the 20-item NUMi (α=.92). S-NUMi scores were strongly correlated with the Lipkus Expanded Health Numeracy Scale (α=.62), the Wide Range of Achievement Test-Mathematics (α=.72), and the Wonderlic Cognitive Ability Test (α=.76). Moderate correlation was found with education level (α=.58) and print literacy as measured by the Test of Functional Health Literacy in Adults (α=.49). Results show that the short form of the NUMi is a reliable and valid measure of health numeracy feasible for use in clinical and research settings.

English-Spanish equivalence of the Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT).

Unbiased measurement instruments are needed to reliably estimate health literacy in diverse populations. The study aimed (a) to evaluate measurement equivalence of Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) and (b) to compare Health LiTT scores between English- and Spanish-speaking individuals. Health LiTT and several patient-reported outcome instruments were completed by adult patients receiving care for type 2 diabetes at a safety net clinic. English-Spanish measurement equivalence was evaluated with an item response theory approach to differential item functioning (DIF) detection and impact. Health LiTT scores were compared by language using multivariable linear regression. Approximately equal numbers of English-speaking patients (n=146) and Spanish-speaking patients (n=149) with type 2 diabetes were enrolled. English participants were primarily non-Hispanic Black (65%); all Spanish participants were Hispanic. Six Health LiTT items were flagged for DIF. The Pearson correlation between unadjusted and DIF adjusted scores was 0.995; the mean difference of individual difference scores was 0.0005 (SD=0.0888). After adjusting for predisposing characteristics, enabling resources and need for care, Health LiTT scores were comparable for Spanish-speaking individuals versus English-speaking individuals. The effect of DIF items on Health LiTT scores appeared to be trivial. English-Spanish equivalence of Health LiTT will permit researchers to determine the independent effects of limited English proficiency and limited literacy.

The meaning of numbers in health: exploring health numeracy in a Mexican-American population.

BACKGROUND: Health numeracy can be defined as the ability to use numeric information in the context of health. The interpretation and application of numbers in health may vary across cultural groups. OBJECTIVE: To explore the construct of health numeracy among persons who identify as Mexican American. DESIGN: Qualitative focus group study. Groups were stratified by preferred language and level of education. Audio-recordings were transcribed and Spanish groups (n = 3) translated to English. An analysis was conducted using principles of grounded theory. PARTICIPANTS: A purposeful sample of participants from clinical and community sites in the Milwaukee and Chicago metropolitan areas. MAIN MEASURES: A theoretical framework of health numeracy was developed based upon categories and major themes that emerged from the analysis. KEY RESULTS: Six focus groups were conducted with 50 participants. Initial agreement in coding was 59-67% with 100% reached after reconciliation by the coding team. Three major themes emerged: 1) numeracy skills are applied to a broad range of communication and decision making tasks in health, 2) affective and cognitive responses to numeric information influence use of numbers in the health setting, and 3) there exists a strong desire to understand the meaning behind numbers used in health. The findings informed a theoretical framework of health numeracy. CONCLUSIONS: Numbers are important across a range of skills and applications in health in a sample of an urban Mexican-American population. This study expands previous work that strives to understand the application of numeric skills to medical decision making and health behaviors.

Individualizing Surveillance Mammography for Older Patients After Treatment for Early-Stage Breast Cancer: Multidisciplinary Expert Panel and International Society of Geriatric Oncology Consensus Statement.

IMPORTANCE: There is currently no guidance on how to approach surveillance mammography for older breast cancer survivors, particularly when life expectancy is limited. OBJECTIVE: To develop expert consensus guidelines that facilitate tailored decision-making for routine surveillance mammography for breast cancer survivors 75 years or older. EVIDENCE: After a literature review of the risk of ipsilateral and contralateral breast cancer events among breast cancer survivors and the harms and benefits associated with mammography, a multidisciplinary expert panel was convened to develop consensus guidelines on surveillance mammography for breast cancer survivors 75 years or older. Using an iterative consensus-based approach, input from clinician focus groups, and critical review by the International Society for Geriatric Oncology, the guidelines were refined and finalized. FINDINGS: The literature review established a low risk for ipsilateral and contralateral breast cancer events in most older breast cancer survivors and summarized the benefits and harms associated with mammography. Draft mammography guidelines were iteratively evaluated by the expert panel and clinician focus groups, emphasizing a patient's risk for in-breast cancer events, age, life expectancy, and personal preferences. The final consensus guidelines recommend discontinuation of routine mammography for all breast cancer survivors when life expectancy is less than 5 years, including those with a history of high-risk cancers; consideration to discontinue mammography when life expectancy is 5 to 10 years; and continuation of mammography when life expectancy is more than 10 years. Individualized, shared decision-making is encouraged to optimally tailor recommendations after weighing the benefits and harms associated with surveillance mammography and patient preferences. The panel also recommends ongoing clinical breast examinations and diagnostic mammography to evaluate clinical findings and symptoms, with reassurance for patients that these practices will continue. CONCLUSIONS AND RELEVANCE: It is anticipated that these expert guidelines will enhance clinical practice by providing a framework for individualized discussions, facilitating shared decision-making regarding surveillance mammography for breast cancer survivors 75 years or older.

The expanding use of third-generation aromatase inhibitors: what the general internist needs to know.

BACKGROUND: Breast cancer patients represent the largest group of adult cancer survivors in the US. Most breast cancers in women 50 years of age and older are hormone receptor positive. Third generation aromatase inhibitors (AIs) are the newest class of drugs used in treating hormone responsive breast cancer. It is often during start of adjuvant hormone therapy that the breast cancer patient establishes (or reestablishes) close follow-up with their general internist. OBJECTIVE: Given the large numbers of breast cancer patients in the US and the increasing use of third generation AI's, general internists will need to have a clear understanding of these drugs including their benefits and potential harms. Currently there are three third generation aromatase inhibitors FDA approved for use in the US. All have been shown to be superior to tamoxifen in disease free survival (DFS) in the treatment of both metastatic and early breast cancers. RESULTS: While the data on side effects is limited, AI (compared to tamoxifen) may result in higher rates of osteoporosis and fractures, more arthralgias, and increased vaginal dryness and dysparuenia. Limited information on their effects on the cardiovascular system and neuro-cognitive function are also available. Patient's receiving adjuvant hormone therapy are generally considered disease free or disease stable and require less intensive monitoring by their breast cancer specialist. CONCLUSIONS: In situations where patients experience significant negative side effects from AI therapy, discussions to discontinue treatment (and switch to an alternative endocrine therapy) should involve the cancer specialist and take into consideration the patient's risk for breast cancer recurrence and the impact of therapy on their quality of life. In some cases, patients may choose to never initiate AI treatment. In other cases, patients may choose to prematurely discontinue therapy even if therapy is well tolerated. In both settings increased knowledge by the general internists will likely facilitate discussions of risks versus benefits of therapy and possibly improve compliance to adjuvant hormone therapy.

Update in women's health.

INTRODUCTION: The aim of this clinical update is to summarize articles and guidelines published in the last year with the potential to change current clinical practice as it relates to women's health. METHODS: We used two independent search strategies to identify articles relevant to women's health published between March 1, 2007 and February 29, 2008. First, we reviewed the Cochrane Database of Systematic Reviews and journal indices from the ACP Journal Club, Annals of Internal Medicine, Archives of Internal Medicine, British Medical Journal, Circulation, Diabetes, JAMA, JGIM, Journal of Women's Health, Lancet, NEJM, Obstetrics and Gynecology, and Women's Health Journal Watch. Second, we performed a MEDLINE search using the medical subject heading term "sex factors." The authors, who all have clinical and/or research experience in the area of women's health, reviewed all article titles, abstracts, and, when indicated, full publications. We excluded articles related to obstetrical aspects of women's health focusing on those relevant to general internists. We had two acceptance criteria, scientific rigor and potential to impact women's health. We also identified new and/or updated women's health guidelines released during the same time period. RESULTS: We identified over 250 publications with potential relevance to women's health. Forty-six articles were selected for presentation as part of the Clinical Update, and nine were selected for a more detailed discussion in this paper. Evidence-based women's health guidelines are listed in Table 1. Table 1 Important Women's Health Guidelines in 2007-2008: New or Updated Topic Issuing organization Updated recommendations and comments Mammography screening in women 40-4917 ACP Individualized risk assessment and informed decision making should be used to guide decisions about mammography screening in this age group. To aid in the risk assessment, a discussion of the risk factors, which if present in a woman in her 40s increases her risk to above that of an average 50-year-old woman, is provided in the guidelines. In addition, available risk prediction models, such as the NIH Web site calculator (http://www.cancer.gov/bcrisktool/) can also be used to estimate quantitative breast cancer risk. This model was updated in 2008 with race-specific data for calculating risk in African-American women.18 The harms and benefits of mammography should be discussed and incorporated along with a woman's preferences and breast cancer risk profile into the decision on when to begin screening. If a woman decides to forgo mammography, the decision should be readdressed every 1 to 2 years. STD screening guidelines19 USPSTF and CDC Routine screening for this infection is now recommended for ALL sexually active women age 24 and under, based on the recent high prevalence estimates for chlamydia It is not recommended for women (pregnant or nonpregnant) age 25 and older, unless they are at increased risk for infection. STD treatment guidelines20 CDC Flouroquinolones are NO longer recommended for treatment of N. gonorrhea, due to increasing resistance (as high as 15% of isolates in 2006). For uncomplicated infections, treatment of gonorrhea should be initiated with ceftriaxone 125 mg IM or cefixime 400 mg PO and co-treatment for chlamydia infection (unless ruled out with testing). Recent estimates demonstrate that almost 50% of persons with gonorrhea have concomitant chlamydia infection21. STD = sexually transmitted disease, NIH = National Institutes of Health, ACP = American College of Physicians, USPSTF = United States Prevention Services Task Force, CDC = Centers for Disease Control.

Cancer survivorship care: exploring the role of the general internist.

According to the National Cancer Institute (NCI), cancer survivorship encompasses the "physical, psychosocial, and economic issues of cancer from diagnosis until the end of life." Today, one in 30 Americans are cancer survivors. Almost two-thirds have at least one chronic health condition. As the numbers of cancer survivors increase, cancer itself can be viewed as a chronic medical condition. This paper illustrates some of the challenges faced by cancer survivors. We discuss the limitations of current models of survivorship care, including shared care. In addition, we explore how the American Board of Internal Medicine's previously proposed credential of Comprehensive Care Internist could serve to define and integrate the complex needs of adult cancer survivors with the skills and talents of general internists.

Communication and Shared Decision Making in the Breast Cancer Treatment Consultation: A Comparative Analysis of English- and Spanish-Speaking Patients.

Background. Communication in the breast cancer treatment consultation is complex. Language barriers may increase the challenge of achieving patient-centered communication and effective shared decision making. Design. We conducted a prospective cohort study among Spanish- and English-speaking women with stage 0 to 3 breast cancer in two urban medical centers in the Midwestern United States. Patient centeredness of care and decisional conflict were compared between Spanish- and English-speaking participants using the Interpersonal Processes of Care (IPC) and Decision Conflict Scale (DCS), respectively. Clinician behaviors of shared decision making were assessed from consultation audio-recordings using the 12-item Observing Patient Involvement in Decision Making (OPTION) scale. Multivariate regression analyses were conducted to control for differences in baseline characteristics and clinician specialty. Results. Fifteen Spanish-speaking and 35 English-speaking patients were enrolled in the study. IPC scores (median, interquartile range [IQR]) were higher (less patient centered) in Spanish- versus English-speaking participants in the domains of lack of clarity (2.5, 1-3 v. 1.5, 1-2), P = 0.028; perceived discrimination (1.1, 1-1 v. 1.0, 1-1), P = 0.047; and disrespectful office staff (1.25, 1-2 v. 1.0, 1-1), P < 0.0005 (Wilcoxon rank-sum test). OPTION scores (median, IQR) were lower in Spanish- versus English-speaking participants (21.9, 17.7-27.1 v. 31.3, 26.6-39.6), P = 0.001 (Wilcoxon rank-sum test). In multivariate analysis, statistically significant differences persisted in the IPC lack of clarity and disrespectful office staff between Spanish- and English-speaking groups. Conclusions. Our findings highlight challenges in cancer communication for Spanish-speaking patients, particularly with respect to perceived patient centeredness of communication. Further cross-cultural studies are needed to ensure effective communication and shared decision making in the cancer consultation.

Improving Communication in Breast Cancer Treatment Consultation: Use of a Computer Test of Health Numeracy.

Background: Communication of statistics and probability is challenging in the cancer care setting. The objectives of this study are to evaluate a novel approach to cancer communication through the use of a computer assessment of patient health numeracy. Methods: We conducted a pilot study of the Computer Adapted Test of Numeracy Understanding in Medicine Instrument (CAT-NUMi) before the cancer treatment consultation for women with stage 0-3 breast cancer. Patient outcomes included the interpersonal processes of care (IPC) and the decisional conflict scale. We evaluated clinician use of numeric information in the cancer consultation and assessed feasibility outcomes from the clinician and patient perspective. Results: Patient participants (n = 50) had a median (interquartile range) age of 51 years (46-61), 70% were English speaking, and 30% Spanish speaking. Decisional conflict was low with a mean (standard deviation [SD]) decisional conflict score of 17.4 (12.3). The lack of clarity score (range 1-5) on the IPC was low (mean, SD),1.70 (0.71), indicating clear communication. Clinicians more often used percentages in communicating prognosis among those with higher numeracy scores (median, range): high (2, 0-8), medium (1, 0-7), and low (0, 0-8); p = 0.04. The patient experience of taking the CAT-NUMi was rated as very good or excellent by 65%, fair by 33%, and poor by 2% of patients. Conclusion: Screening for health numeracy with a short computer-based test may be a feasible strategy to optimize clear communication in the cancer treatment consultation. Further studies are needed to evaluate this strategy across cancer treatment clinical settings and populations.

Use and Patient-Reported Outcomes of Clinical Multigene Panel Testing for Cancer Susceptibility in the Multicenter Communication of Genetic Test Results by Telephone Study.

PURPOSE: Multigene panels (MGPs) are increasingly being used despite questions regarding their clinical utility and no standard approach to genetic counseling. How frequently genetic providers use MGP testing and how patient-reported outcomes (PROs) differ from targeted testing (eg, BRCA1/2 only) are unknown. METHODS: We evaluated use of MGP testing and PROs in participants undergoing cancer genetic testing in the multicenter Communication of Genetic Test Results by Telephone study (ClinicalTrials.gov identifier: ), a randomized study of telephone versus in-person disclosure of genetic test results. PROs included genetic knowledge, general and state anxiety, depression, cancer-specific distress, uncertainty, and satisfaction. Genetic providers offered targeted or MGP testing based on clinical assessment. RESULTS: Since the inclusion of MGP testing in 2014, 395 patients (66%) were offered MGP testing. MGP testing increased over time from 57% in 2014 to 66% in 2015 (P = .02) and varied by site (46% to 78%; P < .01). Being offered MGP testing was significantly associated with not having Ashkenazi Jewish ancestry, having a history of cancer, not having a mutation in the family, not having made a treatment decision, and study site. After demographic adjustment, patients offered MGP testing had lower general anxiety (P = .04), state anxiety (P = .03), depression (P = .04), and uncertainty (P = .05) pre-disclosure compared with patients offered targeted testing. State anxiety (P = .05) and cancer-specific distress (P = .05) were lower at disclosure in the MGP group. There was a greater increase in change in uncertainty (P = .04) among patients who underwent MGP testing. CONCLUSION: MGP testing was more frequently offered to patients with lower anxiety, depression, and uncertainty and was associated with favorable outcomes, with the exception of a greater increase in uncertainty compared with patients who had targeted testing. Addressing uncertainty may be important as MGP testing is increasingly adopted.

Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results.

Background: Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Methods: Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided. Results: A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02). Conclusions: Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.

Tailoring Educational and Behavioral Interventions to Level of Health Literacy: A Systematic Review.

Background: The relative value of universal compared to contingent approaches to communication and behavioral interventions for persons of low health literacy remains unknown. Objective: To examine the effectiveness of interventions that are tailored to individual health literacy level compared to nontailored interventions on health-related outcomes. Design: Systematic review. Data Sources: PubMed and Embase databases. Eligibility Criteria: Studies were eligible if they were in English, used an experimental or observational design, included an intervention that was tailored based on the individual's level of education, health literacy or health numeracy, and had a comparator group in which the intervention was not tailored to individual characteristics. Review Methods: Databases were searched from inception to January 2016, and the retrieved reference lists hand searched. Abstracts that met PICOS criteria underwent dual review for data extraction to assess study details and study quality. A qualitative synthesis was conducted. Results: Of 2,323 unique citations, 458 underwent full review, and 9 met criteria for the systematic review. Five studies were positive and rated as good quality, 3 were negative with 2 of those of good quality, and 1 had mixed results (fair quality). Positive studies were conducted in the clinical domains of hypertension, diabetes, and depression with interventions including educational materials, disease management sessions, literacy training, and physician notification of limited health literacy among patients. Negative studies were conducted in the clinical domains of heart disease, glaucoma, and nutrition with interventions including medication reconciliation and educational materials. Conclusions: Tailoring communication and behavioral interventions to the individual level of health literacy may be an effective strategy to improve knowledge and indicators of disease control in selected clinical settings.

"Why take it if you don't have anything?" breast cancer risk perceptions and prevention choices at a public hospital.

BACKGROUND: Despite advances in breast cancer risk assessment and risk reduction technologies, little is still known about how high-risk women make sense of their risk and assess prevention options, particularly among minority and low-income women. Qualitative methods explore the complex meanings and logics of risk and prevention that quantitative approaches overlook. OBJECTIVE: This study examined how women attending a high risk breast cancer clinic at a public hospital conceptualize their breast cancer risk and think about the prevention options available to them. METHODS: Semi-structured interviews were used to gather data from 33 high-risk women (75% African American) between May and August 2004. Interview transcripts were analyzed for recurrent themes and patterns. RESULTS: Despite general awareness of their objective risk status, many women in this study reported they did not feel "high risk" because they lacked signs and symptoms of cancer. Risk was described as an experienced acute problem rather than a statistical possibility. Women also frequently stated that thinking about cancer might cause it to happen and so it is better not to "dwell on it." While screening was welcomed, women were generally skeptical about primary prevention. In particular, preventive therapies were perceived to cause problems and were only acceptable as treatment options for a disease. CONCLUSIONS: The body of ideas about risk and prevention expressed by this population differ from the medical model. These findings have implications for risk perception research as well as for the efficacy of risk communication and prevention counseling in clinical contexts.