Patient Perspectives on Religiously Affiliated Care in Rural and Urban Colorado.

INTRODUCTION: Religiously affiliated healthcare organizations play an important role in the delivery of care in the United States. There is a gap in the literature regarding patients' attitudes toward receiving care at these institutions, especially in geographically diverse populations. METHODS: In this two-site pilot study, we conducted a written survey of 141 adult primary care patients at non-religiously affiliated clinics in rural and urban Colorado. Demographic information, measures of religiosity and spirituality, and opinions regarding religiously affiliated care were collected. RESULTS: 73.3% and 69.6% of patients in rural and urban counties, respectively, had no preference as to the religious affiliation of their care. However, patients in the urban county (24.1%) were more likely than those in the rural county (8.3%) to prefer care that was not affiliated with any religion. CONCLUSIONS: This study suggests that concerns such as proximity to care and patient/provider relationships may be more important to patients than the possible religious affiliation of a healthcare organization. This work is a first step in better understanding patients' attitudes toward religiously affiliated care in urban versus rural settings.

Patient desire for spiritual assessment is unmet in urban and rural primary care settings.

BACKGROUND: Incorporation of patient religious and spiritual beliefs in medical care has been shown to improve the efficacy of medical interventions and health outcomes. While previous study has highlighted differences in patient desire for spiritual assessment based on patient religiosity, little is known about patient desire for spiritual assessment based on community type, particularly in urban compared to rural communities. We hypothesized that, given demographic trends which show a higher degree of religiosity in rural areas, patients in rural communities will be more likely to desire spiritual assessment. METHODS: In this cross-sectional study of 141 adult primary care patients in rural and urban Colorado at non-religiously affiliated clinics, we surveyed patient demographic information, measures of religiosity, patient desire for spiritual assessment, and frequency of spiritual assessment in practice. Univariate logistic regression analyses were used to compare the two populations. RESULTS: In both Denver County (urban) and Lincoln County (rural) over 90% of patients identified as religious, spiritual, or a combination of the two. Thirty eight percent (38.3%) of patients in Denver County and 49.1% of patients in Lincoln desired spiritual assessment. Over 97% of patients in both areas reported rarely or never being asked about their R/S within the past year. For patients who have had five or more clinic visits in the past year, more than 91% in both areas stated they have never or rarely been asked about their beliefs. CONCLUSIONS: While the majority of patients in this study identify as religious or spiritual and many patients desire spiritual assessment, the majority of patients have never or rarely been asked about their spirituality within the past year. This demonstrates a significant gap between patient preference and provider practice of spiritual assessment in the primary care setting, which was similar in both rural and urban settings. This highlights the need for interdisciplinary focus on spiritual assessment and incorporation of patient R/S beliefs in medical care to provide holistic patient care and improve health outcomes.

Duties When an Anonymous Student Health Survey Finds a Hot Spot of Suicidality.

Public health agencies regularly survey randomly selected anonymous students to track drug use, sexual activities, and other risk behaviors. Students are unidentifiable, but a recent project that included school-level analysis discovered a school with alarmingly prevalent student suicidality. Given confidentiality protocols typical of surveillance, the surveyors were uncertain whether and how to intervene. We searched literature for duties to warn at-risk groups discovered during public health surveillance, but we found no directly applicable guidance or cases. Reasoning by analogy, we conclude that surveyors should contact the school's leaders to call attention to its outlier status, but public warning is unwarranted. However, such an ad hoc decision to issue a warning, even if only to school leaders, raises significant practical, legal and ethical issues. National public health and education associations should produce guidance that clarifies ethical and legal duties owed to schools and students involved in population health-risk surveillance.

Cannabis use disorder and male sex predict medical cannabis card status in a sample of high risk adolescents.

OBJECTIVE: To examine if a substance use disorder (SUD), especially cannabis use disorder in adolescence, predicts future medical cannabis card status among high-risk youth. METHODS: Data collection occurred in Denver and San Diego. We recruited adolescents, with or at high risk for SUD and conduct problems (hereafter probands) and their siblings (n=654). Baseline (Wave 1) assessments took place between 1999 and 2008, and follow-up (Wave 2) took place between 2010 and 2013. In initial bivariate analyses, we examined whether baseline DSM-IV cannabis abuse/dependence (along with other potential predictors) was associated with possessing a medical cannabis card in young adulthood (Wave 2). Significant predictors were then included in a multiple binomial regression. Self-reported general physical health was also evaluated at both time points. Finally, within Wave 2, we tested whether card status was associated with concurrent substance dependence. RESULTS: About 16% of the sample self-reported having a medical cannabis card at follow-up. Though bivariate analyses demonstrated that multiple predictors were significantly associated with Wave 2 card status, in our multiple binomial regression only cannabis abuse/dependence and male sex remained significant. At Wave 2, those with a medical cannabis card were significantly more likely to endorse criteria for concurrent cannabis dependence. There was no significant difference in self-reported general physical health. CONCLUSIONS: Cannabis abuse/dependence and male sex positively predicted future medical cannabis card holder status among a sample of high risk adolescents. Physicians conducting evaluations for medical cannabis cards should carefully evaluate and consider past and concurrent cannabis addiction.

Translating Biobank Science into Patient-Centered Language.

INTRODUCTION: This project used Boot Camp Translation (BCT) to translate the complex medical jargon of biobanking into locally relevant evidence-based messages and materials to support increased knowledge and understanding in the local community. METHODS: Biobank BCT was a partnership of 16 community members and 5 academic researchers. The partnership met for 8 months. RESULTS: The partnership developed five main and seven submessages to assist patients and community members in making an informed decision about enrollment in a biobank. DISCUSSION: The resulting messages balance an individual's right to privacy and choice, while encouraging participation for the greater good.

Adolescents with substance use disorder and assent/consent: Empirical data on understanding biobank risks in genomic research.

OBJECTIVE: This study assessed whether a customized disclosure form increases understanding for adolescents with substance use disorder (SUD) when compared to a standard disclosure for genomic addiction research. METHOD: We gathered empirical data from adolescents with SUD, family members, former patients followed since adolescence, and community counterparts. The study was conducted in four stages. Stage 1: national experts (n=32) identified current, future, speculative risks of broadly shared biobanks. Stage 2 assessed participants' (n=181) understanding of current risks as a prerequisite for rating saliency of risks via a Visual Analog Scale. Salient risks were incorporated into a customized disclosure form. Stage 3 compared the understanding of customized disclosure by participants (n=165) at baseline; all groups scored comparably. Stage 4 conducted a direct comparison of the standard disclosure to standard disclosure plus customized disclosure (n=195). Independent t-tests compared understanding in those receiving the standard disclosure to standard disclosure plus customized disclosure within 6 groups. RESULTS: The customized disclosure significantly improved understanding in adolescent patients (p=0.002) and parents of patients (p=0.006) to the level of their counterparts. The customized disclosure also significantly improved understanding in siblings of former patients (p=0.034). Understanding of standard disclosure in patients versus controls was significantly different (p=0.005). The groups receiving the customized disclosure scored significantly higher. Understanding of the standard disclosure plus customized disclosure in patients versus controls was not significantly different. CONCLUSION: Adolescents with addictions understand the risks of participating in genomic addiction research as well as their community counterparts when information provided is salient to them.

Ethical precepts for medical volunteerism: including local voices and values to guide RHD surgery in Rwanda.

At the invitation of the Rwandan Government, Team Heart, a team of American healthcare professionals, performs volunteer rheumatic heart disease (RHD) surgery in Rwanda every year, and confronts ethical concerns that call for cultural sensitivity. This article describes how five standard bioethical precepts are applied in practice in medical volunteerism related to RHD surgery in Rwanda. The content for the applied precepts stems from semiscripted, transcribed conversations with the authors, two Rwandan cardiologists, a Rwandan nurse and a Rwandan premedical student. The conversations revealed that the criteria for RHD surgical selection in Rwanda are analogous to the patient-selection process involving material scarcity in the USA. Rwandan notions of benefit and harm focus more attention on structural issues, such as shared benefit, national reputation and expansion of expertise, than traditional Western notions. Harm caused by inadequate patient follow-up remains a critical concern. Gender disparities regarding biological and social implications of surgical valve choices impact considerations of justice. Individual agency remains important, but not central to Rwandan concepts of justice, transparency and respect, particularly regarding women. The Rwandan understanding of standard bioethical precepts is substantively similar to the traditionally recognised interpretation with important contextual differences. The communal importance of improving the health of a small number of individuals may be underestimated in previous literature. Moreover, openness and the incorporation of Rwandan stakeholders in difficult ethical choices and long-term contributions to indigenous medical capacity appear to be valued by Rwandans. These descriptions of applied precepts are applicable to different medical missions in other emerging nations following a similar process of inclusion.

Adolescent perspectives on the return of individual results in genomic addiction research.

This study surveyed all adolescents who were enrolled in behavioral genomic research and provided DNA to a biobank, including 320 patients undergoing treatment for substance and conduct problems (SCPs) and 109 non-SCP controls. Participants selected from three options on the return of individual genomic results (RIR) and rated eight methods of re-contact. Most individuals with SCPs (77.8%) and non-SCP controls (72.5%) wanted RIR involving health or behavioral implications. The majority of individuals with SCPs (67.2%) and non-SCP controls (69.7%) indicated that phone re-contact was 'best', with e-mail (22.5% SCPs, 33.9% non-SCPs) and social networking websites (21.3% SCPs, 20.2% non-SCPs) being viable options. These results suggest a layered approach for RIR: phone calls, followed by e-mails and a secure message to a social networking account. Data from this special and vulnerable population, which includes youth involved in the criminal justice system and substantial minority participation, bring an essential and missing perspective to the discussion of RIR.

What adolescents enrolled in genomic addiction research want to know about conflicts of interest.

BACKGROUND: Perspectives of adolescent research participants regarding conflicts of interest (COIs) and their impact on trust in researchers have not been studied. This study evaluates views of adolescent patients in treatment for substance and conduct problems compared to controls enrolled in genomic addiction research. METHODS: Participants included 273 (190 patients, 83 controls) adolescents. Participants consented or assented (with parental consent) to have their genomic information deposited in a NIH biobank that shares information globally with qualified investigators. As part of that study, participants completed a COI survey. Endorsement of each COI item was analyzed with multiple logistic regressions, evaluating group, age, sex, ethnicity, and highest grade completed. RESULTS: Patients and controls differed in gender, ethnicity and highest grade completed. In response to the survey, 38.4% of patients and 25.3% of controls "want to know" and 35.3% of patients and 37.3% of controls "might want to know" about COIs. Males were less likely to want/might want disclosure about COIs. Older patients were more likely to want disclosure about financial interests; patients were more likely to want disclosure about possible treatments; males were more likely to want information about monetary gains. Both groups requested between 1 paragraph and 1 page of information. Disclosure of COIs did not impact trust for most participants. CONCLUSION: Adolescent patients and controls in this study want comparable information for disclosure of COIs including monetary gains, salary, publications, grants, and professional awards. Notably, the majority of patients and controls report that disclosure will not undermine trust in researchers.

Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.

BACKGROUND: Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study. METHODS: The CC/PD was guided by the four bioethical principles. We used a multimedia approach, including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County's population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (eg, Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT study website. RESULTS: A total of 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost more than $84,000. CONCLUSION: The CC/PD process is resource-intensive, costly, and complex. Although the multimedia CC/PD reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.

Reporting actionable research results: shared secrets can save lives.

In this Commentary, we describe a cryptographic method for returning research results to individuals who participate in clinical studies. Controlled use of this method, which relaxes the typical anonymization guarantee, can ensure that clinically actionable results reach participants while also addressing most privacy concerns.

Informed consent process in Alpha-1 testing of at-risk children: views of parents and adults tested as children.

Targeted testing programs are identifying increasing numbers of adults affected by Alpha-1 Antitrypsin Deficiency (Alpha-1) who are making decisions about genetic testing for their at-risk children. Although there are possible benefits, there are also potential risks. The purpose of this pilot study was to explore attitudes toward testing at-risk children from the first hand perspective of those involved, identify the benefits and risks experienced therein, and compare the views of parents and adults tested as children (ATC). The results of this pilot study suggest that ATC were significantly more favorable to including children in testing decisions than parents. ATC strongly indicated that they want to be involved in the testing decision and give permission prior to testing (p = 0.007). While the majority of ATC and parents were in favor of newborn screening for Alpha-1, parents had more extreme views, both positive and negative (p = 0.04). Both ATC and parents expressed significantly higher likelihoods of possible risks and benefits following Alpha-1 testing than they actually experienced. Results do not reveal serious harms from testing at-risk children. The two groups indicated that they want information regarding access to insurance, inheritance and expression, impact on anxiety, association with smoking, and usefulness in future planning prior to a decision to test or not to test at risk children. From the resulting data and ethical analysis we recommend that parents and children have relevant information prior to testing for Alpha-1 and that at risk children are directly involved in the decision-making process prior to testing.

The ethics of using transgenic non-human primates to study what makes us human.

A flood of comparative genomic data is resulting in the identification of human lineage-specific (HLS) sequences. As apes are our closest evolutionary relatives, transgenic introduction of HLS sequences into these species has the greatest potential to produce 'humanized' phenotypes and also to illuminate the functions of these sequences. We argue that such transgenic apes would also be more likely than other species to experience harm from such research, which renders such studies ethically unacceptable in apes and justifies regulatory barriers between these species and other non-human primates for HLS transgenic research.

Substance use disorder genetic research: investigators and participants grapple with the ethical issues.

OBJECTIVE: This qualitative research examined the ethical concerns regarding the psychosocial issues, research design and implementation, and application of psychiatric genetic research on substance use disorders (SUD) from multiple perspectives. METHODS: A literature review of the bioethics literature related to psychiatric genetics and focus groups explored the ethical implications of SUD genetic research. Twenty-six National Institute on Drug Abuse funded principal investigators in the field of psychiatric genetic research, nine adolescent patients in residential SUD treatment, and 10 relatives of patients participated in focus groups (held separately). The focus groups were recorded, transcribed, and the content was analyzed. The themes that emerged from the literature and the focus group transcripts were organized by using NVIVO7, a software package designed to manage, analyze, and compare narrative data. RESULTS: Investigators and the literature expressed similar concerns regarding the ethical concerns associated with psychiatric genetic research including violation of privacy, misunderstanding about psychiatric genetics, stigmatization, commercialization, discrimination, eugenics, consequences of research on illegal behavior, unforeseen consequences, altered notion of individual responsibility, and others. Patients and their relatives showed little familiarity with the ethical issues as identified by professionals and little concern regarding most of the potential risks. The exception was apprehension associated with potential criminal justice uses of stored genetic information, in particular enforced therapy and stigmatization, which elicited some concern from all perspectives. CONCLUSION: The challenge for further research is to identify risks and benefits of SUD research that are germane in a behaviorally disinhibited population and devise effective tools to communicate information to participants through an improved informed consent process.

Anxiety related to genetic testing for alpha-1 antitrypsin deficiency and cystic fibrosis in COPD and/or bronchiectasis patients.

OBJECTIVE: To describe the psychological reaction to information about diagnostic genetic testing for alpha-1 antitrypsin deficiency (Alpha-1) and cystic fibrosis (CF) in chronic obstructive pulmonary disease and/or bronchiectasis patients who were tested but did not know the results. METHODS: One hundred and three adults took the State-Trait Anxiety Inventory before and after a standardized educational intervention and responded to a questionnaire. RESULTS: Information about the limitations, risks and benefits of Alpha-1 and CF testing did not raise mean anxiety levels. Mean anxiety was slightly lower after the educational intervention than at baseline (mean pretest score 35.0, posttest score 33.7; p < 0.05). Participants whose physician preinformed them of genetic testing had slightly higher mean anxiety than other participants, both before and after the intervention, but scores were comparable to those in a normative sample of general medical and surgical patients. CONCLUSIONS: Disclosure of information regarding Alpha-1 and CF testing appears to be potentially acceptable to patients and unlikely to prevent clinicians from conducting useful diagnostic procedures. This study is a step in alleviating concerns about raising issues related to genetic testing for Alpha-1 and CF in chronic obstructive pulmonary disease patients during the informed consent process.