The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.

BACKGROUND: Patients' estimates of their chances of therapeutic benefit from participation in early phase trials greatly exceed historical data. Ethicists worry that this therapeutic misestimation undermines the validity of informed consent. METHODS: The authors interviewed 45 patients enrolled in phase 1 or 2 oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. They used a phenomenological, qualitative approach with 1 primary coder to identify emergent themes, verified by 2 independent coders. RESULTS: Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27 of 45 participants used 1 of these words. Three major themes emerged: 1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; 2) fighting cancer as a battle; and 3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P=.04). CONCLUSIONS: Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early phase clinical trials.

What keeps you up at night? Genetics professionals' distressing experiences in patient care.

PURPOSE: To explore specific patient care experiences that genetics professionals associate with distress and the emotions engendered by those experiences. METHODS: We conducted semistructured telephone interviews with clinical geneticists, genetic counselors, and genetic nurses that focused on a single distressing experience. RESULTS: Fourteen clinical geneticists, 25 genetic counselors, and 14 nurses were interviewed. We categorized the situations that interviewees associated with distressing patient care experiences into seven major types: patient/family decisions (27% of total situations), giving bad news (17%), colleague behavior (15%), end-of-life issues (12%), unintended outcomes (12%), difficult patients (8%), and injustice/inhumanity (8%). Interviewees reported experiencing a variety of negative emotions during these situations, including anger, guilt, helplessness, and inadequacy. CONCLUSIONS: The distress and resulting emotions experienced by genetic service providers must be acknowledged. Interventions are needed to assist the clinician in becoming self-aware by reflecting on experienced emotions, examining belief systems and values, and understanding the connection between their emotions and behavior. Involvement in mindfulness meditation, reflective writing, peer support groups or additional communication skill-based training could address this need. In addition, clinicians should seek ways to increase personal meaning derived from providing patient care.

The role and impact of personal faith and religion among genetic service providers.

This paper describes the impact of genetic service providers' personal faith and religious values on their experiences interacting with colleagues and patients. We surveyed 480 clinical geneticists (MDs), genetic counselors (GCs), and genetic nurses randomly selected from their professional associations, and then interviewed a sample of survey respondents. Outcomes included religiosity, coping with distress through spiritual beliefs, and personal value conflicts (PVCs). Two hundred fourteen providers completed the survey out of an estimated 348 eligible (61% response rate). Importance attributed to regular attendance at religious services ranged from 39% (not at all important) to 27% (very important). Reliance on religion and spiritual beliefs as a source of comfort ranged from 48% (never) to 33% (sometimes or often). Religiosity varied by discipline with 58% of nurses thinking regular attendance at religious services was moderately or very important as compared to 47% of GCs and 30% of MDs (P = 0.006). Ten percent of respondents had difficulty reconciling their own faith with being a genetics professional, 14% felt the need to hide their own faith from their colleagues or patients, 7% thought their professional stance was not consistent with their personal values, and 4% felt ostracized by the genetics community because of their personal beliefs. The experience of such PVCs was positively correlated with religiosity (r = 0.35; P < 0.0001). GCs were more likely to experience PVCs than MDs or nurses (P = 0.013). Data from the interviews (N = 54) support these findings. A significant minority of genetic service providers are religiously observant and rely on their religious values to cope with distress. These individuals often experience difficulty reconciling their religious beliefs with the expectations of their profession, and sharing their beliefs with their colleagues and patients. Efforts should be made to prevent or reduce the secrecy surrounding personal faith and religion among genetics professionals.

Development of a revised Health Care System Distrust scale.

CONTEXT: Growing evidence suggests that most forms of distrust are multidimensional, including domains of technical competence and value congruence. Prior measures of health care system distrust have not reflected this multidimensional structure and may be limiting research into the role of health care system distrust in health and health care in the US. OBJECTIVE: To develop a revised a scale of health care system distrust. DESIGN: Three phase study, including focus groups, pilot testing and a cross-sectional telephone survey. PARTICIPANTS: A total of 404 individuals recruited directly from the Greater Philadelphia area or through the University of Pennsylvania Health System. RESULTS: Multilevel consensus coding of focus group transcripts identified 2 primary domains of competence and values with the values domain having subthemes of honesty, motives, and equity. Iterative testing of the initial 76 items led to a final scale of 9 items with a Cronbach's alpha of 0.83. Factor analysis demonstrated a 2-factor structure, corresponding to the domains of values and competence. The values subscale (5 items) had a Cronbach's alpha of 0.73 and the competence subscale (4 items) had a Cronbach's alpha of 0.77. These psychometric properties were similar among African Americans and Whites. CONCLUSIONS: A novel 9-item scale of Health Care System Distrust with high reliability allows the assessment of the 2 primary domains of distrust (values and competence) and may facilitate research in this area.

Differences in the patterns of health care system distrust between blacks and whites.

CONTEXT: Although health care-related distrust may contribute to racial disparities in health and health care in the US, current evidence about racial differences in distrust is often conflicting, largely limited to measures of physician trust, and rarely linked to multidimensional trust or distrust. OBJECTIVE: To test the hypothesis that racial differences in health care system distrust are more closely linked to values distrust than to competence distrust. DESIGN: Cross-sectional telephone survey. PARTICIPANTS: Two hundred fifty-five individuals (144 black, 92 white) who had been treated in primary care practices or the emergency department of a large, urban Mid-Atlantic health system. PRIMARY MEASURES: Race, scores on the overall health care system distrust scale and on the 2 distrust subscales, values distrust and competence distrust. RESULTS: In univariate analysis, overall health care system distrust scores were slightly higher among blacks than whites (25.8 vs 24.1, p = .05); however, this difference was driven by racial differences in values distrust scores (15.4 vs 13.8, p = .003) rather than in competence distrust scores (10.4 vs 10.3, p = .85). After adjustment for socioeconomic status, health/psychological status, and health care access, individuals in the top quartile of values distrust were significantly more likely to be black (odds ratio = 2.60, 95% confidence interval = 1.03-6.58), but there was no significant association between race and competence distrust. CONCLUSIONS: Racial differences in health care system distrust are complex with far greater differences seen in the domain of values distrust than in competence distrust. This framework may be useful for explaining the mixed results of studies of race and health care-related distrust to date, for the design of future studies exploring the causes of racial disparities in health and health care, and for the development and testing of novel strategies for reducing these disparities.

Interest in breast cancer chemoprevention among older women.

OBJECTIVES: The study aim is to describe interest in breast cancer chemoprevention among older women without a history of breast cancer and to determine whether aging-related factors such as diminished life expectancy, increasing comorbidity and medication burden attenuate chemoprevention interest. DESIGN: Cross-sectional survey. SETTING: University of Pennsylvania Health System. PARTICIPANTS: Four-hundred fifty-seven community-dwelling women aged 60-65 years old who were potentially eligible for breast cancer chemoprevention according to guidelines linking risk and eligibility to age. MEASUREMENTS: Interest in breast cancer chemoprevention, Gail model breast cancer risk, perceived breast cancer risk, breast cancer worry, self-reported health status and comorbidities, and self-reported perceived life expectancy. RESULTS: Of 457 participants, 11.2% reported being interested in taking chemoprevention, 40.9% reported no interest, and 47.9% reported being unsure about their interest in chemoprevention. Overall, interest in chemoprevention was not associated with individual Gail model breast cancer risk. In adjusted analysis, lack of interest among high-risk women was associated with low breast cancer worry and low perceived risk. Conversely, interest in chemoprevention among low risk women was associated with greater breast cancer worry. Age-related factors hypothesized to affect chemoprevention interest, including subjective life expectancy, increased comorbidity, and number of daily medications did not attenuate chemoprevention interest. CONCLUSION: Breast cancer worry and perceived breast cancer risk contribute to the lack of correlation between interest in breast cancer chemoprevention and objective breast cancer risk. Perceived life expectancy, increased comorbidity, and medication burden do not attenuate chemoprevention interest among older women.

Prescription of tamoxifen for breast cancer prevention by primary care physicians.

BACKGROUND: Although tamoxifen citrate has been approved for primary reduction of breast cancer risk since 1998, little is known about the prescription of tamoxifen by primary care physicians. METHODS: To investigate the determinants of prescription of tamoxifen for breast cancer prevention by primary care physicians, we mailed a national survey to 350 primary care physicians, including specialties of family practice, obstetrics and gynecology, and general internal medicine, regarding past prescription of tamoxifen, intention to prescribe tamoxifen in hypothetical scenarios, and potential predisposing and enabling factors. RESULTS: Ninety-six physicians (27.4%) reported having prescribed tamoxifen for breast cancer prevention at least once in the prior 12 months. After multivariate adjustment, having prescribed tamoxifen was associated with the physician having a family member with breast cancer (odds ratio [OR], 2.66; 95% confidence interval [CI], 1.21-5.85), patients who asked for information about tamoxifen (OR, 3.98; 95% CI, 1.44-11.04), and the beliefs that the benefits of tamoxifen outweighed the risks (OR, 1.86; 95% CI, 1.07-3.24) and that eligibility was easy to determine (OR, 2.67; 95% CI, 1.35-5.29). In hypothetical scenarios, the prescription of tamoxifen was affected by the patient's family history of breast cancer but not by her risk for endometrial cancer (ie, hysterectomy status). CONCLUSIONS: A minority of primary care physicians have prescribed tamoxifen for breast cancer prevention. The decision to prescribe tamoxifen is affected by the ability to determine eligibility, patient demand, and personal experience with breast cancer as much as perceptions of the risks and benefits. A woman's risk of endometrial cancer from tamoxifen seems to have less impact on prescribing decisions than the magnitude of her breast cancer risk.

Value for the future and breast cancer-preventive health behavior.

BACKGROUND: Time preference, or the extent to which people discount future benefits in favor of immediate benefits, might represent an important determinant of preventive health behavior, but the little research thus far on this association has yielded mixed results. This study examined the association between future time preference and use of genetic counseling for BRCA1/2 testing and how this association may differ from the relationship between future time preference and mammography screening and self-breast examination. EXPERIMENTAL DESIGN: A health system-based case-control study with a nested cross-sectional survey. Eight hundred women who saw a primary care physician in the University of Pennsylvania Health System in the 3 years before the study, of whom 234 had undergone BRCA1/2 counseling (cases) and of whom 566 had not (controls). RESULTS: Placing a relatively greater value on future benefits than present benefits was strongly associated with use of BRCA1/2 counseling [odds ratio (OR), 3.0 for one-point increase in future time preference; 95% confidence intervals (CI), 1.9-4.9]. Future time preference was weakly associated with adherence to annual mammography (OR, 1.3; 95% CI, 0.81-2.2), and was not associated with monthly self-breast examination (OR, 1.03; 95% CI, 0.75-1.4). A stronger future orientation was seen in women who had higher levels of education (P = 0.0021) or income (P = 0.0011). CONCLUSION: Time preference is strongly associated with use of BRCA1/2 counseling. Time preference is more weakly associated with mammography adherence and is not associated with breast self-examination. This variation may reflect the degree to which the behavior is seen as related to future risk.

Racial differences in the use of BRCA1/2 testing among women with a family history of breast or ovarian cancer.

CONTEXT: Given the current context of racial disparities in health and health care and the historical context of eugenics, racial disparities in the use of genetic susceptibility testing have been widely anticipated. However, to our knowledge there are no published studies examining the magnitude and determinants of racial differences in the use of genetic susceptibility testing. OBJECTIVES: To investigate the relationship between race and the use of BRCA1/2 counseling among women with a family history of breast or ovarian cancer and to determine the contribution of socioeconomic characteristics, cancer risk perception and worry, attitudes about genetic testing, and interactions with primary care physicians to racial differences in utilization. DESIGN, SETTING, AND PARTICIPANTS: Case-control study (December 1999-August 2003) of 408 women with a family history of breast or ovarian cancer, of whom 217 underwent genetic counseling for BRCA1/2 testing (cases) and 191 women did not (controls). Participants received primary care within a large health system in greater Philadelphia, Pa. MAIN OUTCOME MEASURES: Probability of carrying a BRCA1/2 mutation, socioeconomic characteristics, perception of breast and ovarian cancer risk, worry about breast and ovarian cancer, attitudes about BRCA1/2 testing, and primary care physician discussion of BRCA1/2 testing were measured prior to undergoing BRCA1/2 counseling for cases and at the time of enrollment for controls. RESULTS: African American women with a family history of breast or ovarian cancer were significantly less likely to undergo genetic counseling for BRCA1/2 testing than were white women with a family history of breast or ovarian cancer (odds ratio, 0.22; 95% confidence interval, 0.12-0.40). This association persisted after adjustment for probability of BRCA1/2 mutation, socioeconomic characteristics, breast and ovarian cancer risk perception and worry, attitudes about the risks and benefits of BRCA1/2 testing, and primary care physician discussion of BRCA1/2 testing (adjusted odds ratio for African American vs white, 0.28; 95% confidence interval, 0.09-0.89). CONCLUSIONS: Racial disparities in the use of BRCA1/2 counseling are large and do not appear to be explained by differences in risk factors for carrying a BRCA1/2 mutation, socioeconomic factors, risk perception, attitudes, or primary care physician recommendations. The benefit of predictive genetic testing will not be fully realized unless these disparities can be addressed.

Differential willingness to undergo smallpox vaccination among African-American and white individuals.

OBJECTIVE: To examine potential disparities in willingness to be vaccinated against smallpox among different U.S. racial/ethnic groups. DESIGN: Cross-sectional survey using an experimental design to assess willingness to be vaccinated among African Americans compared to whites according to 2 strategies: a post-exposure "ring vaccination" method and a pre-exposure national vaccination program. SETTING: Philadelphia County district courthouse. PARTICIPANTS: Individuals awaiting jury duty. MEASUREMENTS: We included 2 scenarios representing these strategies in 2 otherwise identical questionnaires and randomly assigned them to participants. We compared responses by African Americans and whites. MAIN RESULTS: In the pre-exposure scenario, 66% of 190 participants were willing to get vaccinated against smallpox. In contrast, 84% of 200 participants were willing to get vaccinated in the post-exposure scenario (P =.0001). African Americans were less willing than whites to get vaccinated in the pre-exposure scenario (54% vs 77%; P =.004), but not in the post-exposure scenario (84% vs 88%; P =.56). In multivariate analyses, overall willingness to undergo vaccination was associated with vaccination strategy (odds ratio, 3.29; 95% confidence interval, 1.8 to 6.1). CONCLUSIONS: Racial disparity in willingness to get vaccinated varies by the characteristics of the vaccination program. Overall willingness was highest in the context of a post-exposure scenario. These results highlight the importance of considering social issues when constructing bioterror attack response plans that adequately address the needs of all of society's members.