Decision making among Veterans with incidental pulmonary nodules: a qualitative analysis.

PURPOSE: Among patients undergoing lung cancer evaluation for newly diagnosed, incidental pulmonary nodules, it is important to evaluate the shared power and responsibility domain of patient-centered communication. We explored Veterans' perceptions of decision making with regards to an incidentally-detected pulmonary nodule. METHODS: We conducted semi-structured, qualitative interviews of 19 Veterans from one medical center with incidentally-detected pulmonary nodules that were judged as having a low risk for malignancy. We used qualitative description for the analysis, focusing on patients' perceptions of shared decision making with their primary care provider (PCP). Interviews were conducted in 2011 and 2012. RESULTS: Patients almost always played a passive role in deciding how and when to evaluate their pulmonary nodule for the possibility of malignancy. Some patients felt comfortable with this role, expressing trust that their clinician would provide the appropriate care. Other patients were not satisfied with how these decisions were made with some expressing concern that no decisions had actually occurred. Regardless of how satisfied they were with the decision, patients did not report discussing how they liked to make decisions with their PCP. CONCLUSIONS: Veterans in our study did not engage in shared decision making with their clinician. Some were satisfied with this approach although many would have preferred a shared approach. In order to reduce patient distress and improve satisfaction, clinicians may want to consider adopting a shared approach when making decisions about pulmonary nodule evaluation.

The translational potential of research on the ethical, legal, and social implications of genomics.

Federally funded research on the ethical, legal, and social implications (ELSI) of genomics includes a programmatic charge to consider policy-relevant questions and to communicate findings in venues that help inform the policy-making process. In addressing this goal, investigators must consider the range of policies that are relevant to human genetics; how foundational research in bioethics, law, and the social sciences might inform those policies; and the potential professional issues that this translational imperative raises for ELSI investigators. We review these questions in light of experiences from a consortium of federally funded Centers of Excellence in ELSI Research, and offer a set of policy recommendations for program design and evaluation of ELSI research. We conclude that it would be a mistake to require that ELSI research programs demonstrate a direct impact on science or health policy; however, ELSI researchers can take steps to increase the relevance of their work to policy makers. Similarly, funders of ELSI research who are concerned with facilitating policy development can help by building cross-disciplinary translational research capacities, and universities can take steps to make policy-relevant research more rewarding for scholars in the humanities, social sciences, and law.

Essential elements of personalized medicine.

OBJECTIVES: Genomic information has been promoted as the basis for "personalized" health care. We considered the benefits provided by genomic testing in context of the concept of personalized medicine. MATERIALS AND METHODS: We evaluated current and potential uses of genomic testing in health care, using prostate cancer as an example, and considered their implications for individualizing or otherwise improving health care. RESULTS AND CONCLUSIONS: Personalized medicine is most accurately seen as a comprehensive effort to tailor health care to the individual, spanning multiple dimensions. While genomic tests will offer many potential opportunities to improve the delivery of care, including the potential for genomic research to offer opportunities to improve prostate cancer screening and treatment, such advances do not in themselves constitute a paradigm shift in the delivery of health care. Rather, personalized medicine is based on a partnership between clinician and patient that utilizes shared decision making to determine the best health care options among the available choices, weighing the patient's personal values and preferences together with clinical findings. This approach is particularly important for difficult clinical decisions involving uncertainty and trade-offs, such as those involved in prostate cancer screening and management. The delivery of personalized medicine also requires adequate health care access and assurance that basic health needs have been met. Substantial research investment will be needed to identify how genomic tests can contribute to this effort.

Breastfeeding infants with phenylketonuria in the United States and Canada.

OBJECTIVE: This study described the prevalence and duration of mothers' breastfeeding infants with phenylketonuria (PKU) and explored factors related to duration of breastfeeding as a surrogate for breastfeeding success. SUBJECTS AND METHODS: Descriptive analysis as performed from an international Internet survey of mothers (n=103) who met the inclusion criteria: (1) at least 21 years of age, (2) able to read and write in English, (3) child with PKU, and (4) living in the United States or Canada. RESULTS: Of the 103 mothers, 89 (86%) initiated breastfeeding immediately following delivery, whereas 14 (14%) chose bottle feeding. In comparison to breastfeeding after delivery, significantly fewer mothers breastfed after diagnosis (McNemar's χ(2)=30.33, p<0.001; n=72 vs. n=89). Breastfeeding duration ranged from less than 1 month to 24 months with one modal duration category (n=20, 22%) at less than 1 month. The timing of the addition of commercial infant formula to supplement breastfeeding or expressed mothers' milk was associated with a shorter duration of breastfeeding among infants with PKU: χ(2) (42, n=73)=88.13, p<0.001. CONCLUSIONS: PKU is treated with phenylalanine (Phe) restriction. Breastfeeding infants with PKU is challenging in part because Phe intake is difficult to determine precisely. We studied breastfeeding duration in infants with PKU and factors associated with success. Further research should identify the unique needs of mothers' breastfeeding infants with PKU to guide the development of interventions specific to these mothers to support their efforts to continue breastfeeding after the diagnosis of PKU.

What the heck is a "nodule"? A qualitative study of veterans with pulmonary nodules.

RATIONALE: Every year, hundreds of thousands of patients are diagnosed with incidentally detected pulmonary nodules, and if lung cancer screening is widely implemented, thousands more will be identified. The psychosocial outcomes associated with incidental nodule detection in general practice settings are virtually unknown. OBJECTIVES: The purpose of this study was to explore the experiences of patients with incidentally diagnosed pulmonary nodules. METHODS: We conducted qualitative interviews of 19 veterans with incidentally detected pulmonary nodules. We used qualitative description for the analysis, focusing on patients' information exchange and other communication behaviors with their clinicians. MEASUREMENTS AND MAIN RESULTS: The patients were cared for by primary care clinicians and had small nodules that were unlikely to be malignant. Patients did not understand the term "nodule" although they knew it was related to cancer. They also did not understand the follow-up plan and most were unable to obtain better information from their clinician or other sources. Most patients experienced nodule-related distress that was usually mild, although sometimes severe. This distress was sometimes mitigated by patients' confidence in their clinician. Most patients wanted more and better information about their nodule. CONCLUSIONS: Veterans from one hospital have little understanding of what nodules are, the likelihood of malignancy, and the follow-up plan. Their reaction to this knowledge deficit is variable and is likely related to preferred communication behaviors with their clinician. Evaluating communication in other settings is important to confirm these findings and to refine mechanisms to improve patient-centered care for those with incidentally detected pulmonary nodules.

Recommendations for returning genomic incidental findings? We need to talk!

The American College of Medical Genetics and Genomics recently issued recommendations for reporting incidental findings from clinical whole-genome sequencing and whole-exome sequencing. The recommendations call for evaluating a specific set of genes as part of all whole-genome sequencing/whole-exome sequencing and reporting all pathogenic variants irrespective of patient age. The genes are associated with highly penetrant disorders for which treatment or prevention is available. The effort to generate a list of genes with actionable findings is commendable, but the recommendations raise several concerns. They constitute a call for opportunistic screening, through intentional effort to identify pathogenic variants in specified genes unrelated to the clinical concern that prompted testing. Yet for most of the genes, we lack evidence about the predictive value of testing, genotype penetrance, spectrum of phenotypes, and efficacy of interventions in unselected populations. Furthermore, the recommendations do not allow patients to decline the additional findings, a position inconsistent with established norms. Finally, the recommendation to return adult-onset disease findings when children are tested is inconsistent with current professional consensus, including other policy statements of the American College of Medical Genetics and Genomics. Instead of premature practice recommendations, we call for robust dialogue among stakeholders to define a pathway to normatively sound, evidence-based guidelines.

Trust is the basis for effective suicide risk screening and assessment in veterans.

BACKGROUND: To reduce suicides among Veterans, the Department of Veterans Affairs (VA) has designated suicide risk assessments for Veterans who screen positive for depression or post-traumatic stress disorder as a national performance goal. Many VA Medical Centers (VAMCs) are using brief suicidal ideation screens, administered in non-mental health ambulatory care settings, as the first step in the assessment process. OBJECTIVE: To explore Veterans' perceptions of the suicide screening and risk assessment process, the barriers and facilitators to disclosing suicidal thoughts, and perceptions of possible consequences of revealing suicidal thoughts. DESIGN: Investigators recorded one semi-structured interview with each Veteran. Transcripts were analyzed using a modified grounded theory approach. PARTICIPANTS: Thirty-four Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans who screened positive for suicidal ideation in non-mental health ambulatory care settings in 2009 and 2010. KEY RESULTS: Veterans accepted the need to assess suicide risk. They increasingly experienced attempts to suppress and avoid thoughts of suicide as burdensome and exhausting. Despite this, Veterans often failed to disclose severe and pervasive suicidal thoughts when screened because: (1) they considered suicidal thoughts as shameful and a sign of weakness; (2) they believed suicidal thoughts were private and not to be divulged to strangers; (3) they worried that disclosure would lead to unwanted hospitalization or medication recommendations; and (4) the templated computer reminder process was perceived as perfunctory and disrespectful. In contrast, admitting and discussing thoughts of suicide with a health provider who focused on building a relationship, demonstrated genuineness and empathy, offered information on the rationale for suicide risk assessment, and used straightforward and understandable language, all promoted trust that resulted in more honest disclosure of suicidal thoughts. CONCLUSION: In ambulatory care settings, both provider behaviors and system modifications may lead to more honest disclosure of suicidal thoughts.

Patient experiences with full electronic access to health records and clinical notes through the My HealtheVet Personal Health Record Pilot: qualitative study.

BACKGROUND: Full sharing of the electronic health record with patients has been identified as an important opportunity to engage patients in their health and health care. The My HealtheVet Pilot, the initial personal health record of the US Department of Veterans Affairs, allowed patients and their delegates to view and download content in their electronic health record, including clinical notes, laboratory tests, and imaging reports. OBJECTIVE: A qualitative study with purposeful sampling sought to examine patients' views and experiences with reading their health records, including their clinical notes, online. METHODS: Five focus group sessions were conducted with patients and family members who enrolled in the My HealtheVet Pilot at the Portland Veterans Administration Medical Center, Oregon. A total of 30 patients enrolled in the My HealtheVet Pilot, and 6 family members who had accessed and viewed their electronic health records participated in the sessions. RESULTS: Four themes characterized patient experiences with reading the full complement of their health information. Patients felt that seeing their records positively affected communication with providers and the health system, enhanced knowledge of their health and improved self-care, and allowed for greater participation in the quality of their care such as follow-up of abnormal test results or decision-making on when to seek care. While some patients felt that seeing previously undisclosed information, derogatory language, or inconsistencies in their notes caused challenges, they overwhelmingly felt that having more, rather than less, of their health record information provided benefits. CONCLUSIONS: Patients and their delegates had predominantly positive experiences with health record transparency and the open sharing of notes and test results. Viewing their records appears to empower patients and enhance their contributions to care, calling into question common provider concerns about the effect of full record access on patient well-being. While shared records may or may not impact overall clinic workload, it is likely to change providers' work, necessitating new types of skills to communicate and partner with patients.

Communication by nurses in the intensive care unit: qualitative analysis of domains of patient-centered care.

BACKGROUND: High-quality communication is a key determinant and facilitator of patient-centered care. Nurses engage in most of the communication with patients and patients' families in the intensive care unit. OBJECTIVE: To perform a qualitative analysis of nurses' communications. METHODS: Ethnographic observations of 315 hours of interactions and 53 semistructured interviews with 33 nurses were conducted in a 26-bed cardiac-medical intensive care unit in an academic hospital and a 26-bed general intensive care unit in a Veterans Affairs hospital in Portland, Oregon. Communication interactions were categorized into 5 domains of patient-centered care. Interviews were analyzed to identify major themes in nurses' roles and preferences for communicating with patients and patients' families within the domains. RESULTS: Most communication occurred in the domains of biopsychosocial information exchange, patient as person, and clinician as person. Nurses endorsed the importance of the domains of shared power and responsibility and therapeutic alliance but had relatively few communication interactions in these areas. Communication behaviors were strongly influenced by the nurses' roles as translators of information between physicians and patients and the patients' families and what the nurses were and were not willing to communicate to patients and patients' families. CONCLUSIONS: Critical care, including communication, is a collaborative effort. Understanding how nurses engage in patient-centered communication in the intensive care unit can guide future interventions to improve patient-centered care.

Life-sustaining treatment decisions in the ICU for patients with ESLD: a prospective investigation.

We conducted a prospective study in the ICU of life-sustaining treatment and comfort care decisions over time in patients with end-stage liver disease (ESLD) from the perspectives of patients, family members, and healthcare professionals. Six patients with ESLD, 19 family members, and 122 professionals participated. The overarching theme describing the decision-making process was "on the train." Four sub-themes positioned patients and family members as passengers with limited control, unable to fully understand the decision-making process. Findings suggest that including patients and family members in non-immediate life-saving decisions and verifying early on their understanding may help to improve the decision-making process.

IRB perspectives on the return of individual results from genomic research.

PURPOSE: Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders-institutional review board (IRB) professionals-has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. METHODS: In-depth interviews with 31 IRB professionals at six sites across the United States. RESULTS: IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants want to know the results. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., Clinical Laboratory Improvement Act (CLIA) lab certification required for return), in practice, the guidance has been overruled to allow ROR (e.g., no CLIA lab performs the assay). CONCLUSION: An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.

Who is attending? End-of-life decision making in the intensive care unit.

PURPOSE: Traditional expectations of the single attending physician who manages a patient's care do not apply in today's intensive care units (ICUs). Although many physicians and other professionals have adapted to the complexity of multiple attendings, ICU patients and families often expect the traditional, single physician model, particularly at the time of end-of-life decision making (EOLDM). Our purpose was to examine the role of ICU attending physicians in different types of ICUs and the consequences of that role for clinicians, patients, and families in the context of EOLDM. METHODS: Prospective ethnographic study in a university hospital, tertiary care center. We conducted 7 months of observations including 157 interviews in each of four adult critical care units. RESULTS: The term "attending physician" was understood by most patients and families to signify an individual accountable person. In practice, "the attending physician" was an ICU role, filled by multiple physicians on a rotating basis or by multiple physicians simultaneously. Clinicians noted that management of EOLDM varied in relation to these multiple and shifting attending responsibilities. The attending physician role in this practice context and in the EOLDM process created confusion for families and for some clinicians about who was making patient care decisions and with whom they should confer. CONCLUSIONS: Any intervention to improve the process of EOLDM in ICUs needs to reflect system changes that address clinician and patient/family confusion about EOLDM roles of the various attending physicians encountered in the ICU.

Predictors of recruited melanoma families into a behavioral intervention project.

BACKGROUND: Examination of families represents an important priority in health research. In this paper we report on individual and family-level factors associated with enrollment in a cancer prevention research project. We approached families affected by melanoma for possible participation in a randomized controlled trial of a web-based communication and support intervention. METHODS: We recruited three family members per family for assessment - the melanoma case, a first-degree relative (FDR), and a relative who is a parent of a child age 18 or younger. Recruitment involved three steps: requesting the physician's consent to approach the melanoma case, approaching the case to request their participation and family contact information, and they approaching the FDRs and parents. RESULTS: Of the 1380 families approached, 313 were enrolled, 263 were excluded because we could not find or contact a family member (FDR or parent), 331 did not have eligible family members, and 473 refused. The most frequently noted reason for refusal was being too busy or having no time. The primary predictors of participation for cases (OR=1.6; CI=1.01-2.51) and FDRs (OR=2.15; CI=1.11-4.13) included higher educational attainment. FDRs were more likely to enroll if they were female (OR=1.77; CI=1.1-.85) and parents were more likely to enroll if the case had been diagnosed more recently (OR=3.3; CI=1.9-5.93), if the parent was partnered (OR=4.37; CI=1.86-10.26), and if the parent lived in the same city as the case (OR=2.88; CI=1.08-7.68). CONCLUSIONS: The results can provide information on potential directions for future family recruitment.

Genetic screening.

Current approaches to genetic screening include newborn screening to identify infants who would benefit from early treatment, reproductive genetic screening to assist reproductive decision making, and family history assessment to identify individuals who would benefit from additional prevention measures. Although the traditional goal of screening is to identify early disease or risk in order to implement preventive therapy, genetic screening has always included an atypical element-information relevant to reproductive decisions. New technologies offer increasingly comprehensive identification of genetic conditions and susceptibilities. Tests based on these technologies are generating a different approach to screening that seeks to inform individuals about all of their genetic traits and susceptibilities for purposes that incorporate rapid diagnosis, family planning, and expediting of research, as well as the traditional screening goal of improving prevention. Use of these tests in population screening will increase the challenges already encountered in genetic screening programs, including false-positive and ambiguous test results, overdiagnosis, and incidental findings. Whether this approach is desirable requires further empiric research, but it also requires careful deliberation on the part of all concerned, including genomic researchers, clinicians, public health officials, health care payers, and especially those who will be the recipients of this novel screening approach.

Personal attributions for melanoma risk in melanoma-affected patients and family members.

Personal attributions for cancer risk involve factors that individuals believe contribute to their risk for developing cancer. Understanding personal risk attributions for melanoma may dictate gene-environment melanoma risk communication strategies. We examined attributions for melanoma risk in a population-based sample of melanoma survivors, first degree family members, and family members who are also parents (N = 939). We conducted qualitative examination of open-ended risk attributions and logistic regression examining predictors (demographics, family member type, perceived risk) of the attributions reported (ultraviolet radiation [UVR] exposure, heredity/genetics, phenotype, personal melanoma history, miscellaneous). We found a predominance of risk attributions to UVR and heredity/genetics (80 and 45% of the sample, respectively). Those reporting higher education levels were more likely to endorse attributions to heredity/genetics, as well as to phenotype, than those of lower education levels. First-degree relatives and parent family members were more likely to endorse heredity/genetic attributions than melanoma survivors; melanoma survivors were more likely to endorse personal history of melanoma attributions compared to first-degree relatives and parent family members. These findings inform the development of risk communication interventions for melanoma families.

Using a family systems approach to investigate cancer risk communication within melanoma families.

OBJECTIVE: The family provides an important communication nexus for information and support exchange about family cancer history, and adoption of family-wide cancer risk reduction strategies. The goals of this study were to (1) use the family systems theory to identify characteristics of this sample of families at increased risk of developing melanoma and (2) to relate familial characteristics to the frequency and style of familial risk communication. METHODS: Participants were first-degree relatives (n=313) of melanoma patients, recruited into a family web-based intervention study. We used multivariable logistic regression models to analyze the association between family functioning and family communication. RESULTS: Most participants were female (60%), with an average age of 51 years. Fifty percent of participants reported that they spoke to their relatives about melanoma risk and people were more likely to speak to their female family members. Familial adaptation, cohesion, coping, and health beliefs were strongly associated with an open style of risk communication within families. None were associated with a blocked style of risk communication. Only cohesion and adaptation were associated with the amount of risk communication that occurred within families. CONCLUSIONS: Overall, individuals who came from families that were more highly cohesive, adaptable, and shared strong beliefs about melanoma risk were more likely to communicate openly about melanoma. The fact that this association was not consistent across blocked communication and communication frequency highlights the multifaceted nature of this process. Future research should focus on the interplay between different facets of communication.

Breast cancer risk communication: assessment of primary care physicians by standardized patients.

PURPOSE: To assess primary care providers' communication about breast cancer risk. METHODS: We evaluated 86 primary care providers' communication of risk using unannounced standardized (simulated) patients. Physicians were randomly assigned to receive one of three cases: (1) moderate risk case (n = 25), presenting with a breast lump and mother with postmenopausal breast cancer; (2) high-risk (maternal side) case (n = 28), presenting with concern about breast cancer risk; and (3) high-risk (paternal side) case (n = 33), presenting with an unrelated problem. After the appointment, three qualitative parameters were assessed by standardized patients on a 3-point scale (3 = highest satisfaction, 1 = lowest): whether the physician took adequate time; acknowledged her concerns; and offered reassurance. RESULTS: Mean satisfaction with physician communication was higher for the moderate risk case (2.92) than for the high-risk paternal case (2.25) or high-risk maternal case (2.42) (P < 0.0001). The score was not influenced by session length, medical specialty, or physician gender. CONCLUSION: Physicians more consistently provided a moderate risk standardized patients with reassurance and support compared with the high-risk cases. Primary care physicians may be more unprepared or uneasy addressing the issues raised by more complex scenarios and may benefit from training in the assessment and communication of breast cancer risk.

Genetic assessment of breast cancer risk in primary care practice.

Family history is increasingly important in primary care as a means to detect candidates for genetic testing or tailored prevention programs. We evaluated primary care physicians' skills in assessing family history for breast cancer risk, using unannounced standardized patient (SP) visits to 86 general internists and family medicine practitioners in King County, WA. Transcripts of clinical encounters were coded to determine ascertainment of family history, risk assessment, and clinical follow-up. Physicians in our study collected sufficient family history to assess breast cancer risk in 48% of encounters with an anxious patient at moderate risk, 100% of encounters with a patient who had a strong maternal family history of breast cancer, and 45% of encounters with a patient who had a strong paternal family history of breast and ovarian cancer. Increased risk was usually communicated in terms of recommendations for preventive action. Few physicians referred patients to genetic counseling, few associated ovarian cancer with breast cancer risk, and some incorrectly discounted paternal family history of breast cancer. We conclude that pedigree assessment of breast cancer risk is feasible in primary care, but may occur consistently only when a strong maternal family history is present. Primary care education should focus on the link between inherited breast and ovarian cancer risk and on the significance of paternal family history. Educational efforts may be most successful when they emphasize the value of genetic counseling for individuals at risk for inherited cancer and the connection between genetic risk and specific prevention measures.

Anticipating dissemination of cancer genomics in public health: a theoretical approach to psychosocial and behavioral challenges.

BACKGROUND: Given the recent sequencing of the human genome, genetic susceptibility information will probably be increasingly useful in the prevention and control of many common diseases, including cancer. PURPOSE: Although much is known about psychosocial factors related to the impact of cancer genetic testing among high-risk families in specialized clinic settings, much less is known about how genetic susceptibility information may contribute to the health and well-being of the general population. METHODS: We present a theoretical synthesis drawn from the health communication and health behavior change traditions to guide research examining psychosocial and behavioral challenges central to dissemination of cancer genomics in public health. RESULTS: These challenges include (a) anticipating individuals' reactions to receiving genetic information that is probabilistic and derived from multiple sources; (b) modeling the influence of public communication about genetics on the population; (c) confronting the need to disseminate cancer genomic information through public health channels; and (d) maximizing opportunities to achieve cancer risk reduction across individuals, families, and local environments. Throughout the article, we use melanoma genomics as an example of the issues requiring attention. CONCLUSIONS: We hope the model helps shape the psychosocial and behavioral research agenda concerning the impact of cancer genomics outside the high-risk clinic.