Spurred on by recent health care reforms and the Triple Aim's goals of improving population healt... more Spurred on by recent health care reforms and the Triple Aim's goals of improving population health outcomes, reducing health care costs, and improving the patient experience of care, emphasis on population health is increasing throughout medicine. Population health has the potential to improve patient care and health outcomes for individual patients. However, specific population health activities may not be in every patient's best interest in every circumstance, which can create ethical tensions for individual physicians and other health care professionals. Because individual medical professionals remain committed primarily to the best interests of individual patients, physicians have a unique role to play in ensuring population health supports this ethical obligation. Using widely recognized principles of medical ethics-nonmaleficence/beneficence, respect for persons, and justice-this article describes the ethical issues that may arise in contemporary population health programs and how to manage them. Attending to these principles will improve the design and implementation of population health programs and help maintain trust in the medical profession.
; for the ACP Ethics, Professionalism and Human Rights Committee* This American College of Physic... more ; for the ACP Ethics, Professionalism and Human Rights Committee* This American College of Physicians position paper aims to inform ethical decision making surrounding participation in shortterm global health clinical care experiences. Although the positions are primarily intended for practicing physicians, they may apply to other health care professionals and should inform how institutions, organizations, and others structure short-term global health experiences. The primary goal of short-term global health clinical care experiences is to improve the health and well-being of the individuals and communities where they occur. In addition, potential benefits for participants in global health include increased awareness of global health issues, new medical knowledge, enhanced physical diagnosis skills when practicing in lowtechnology settings, improved language skills, enhanced cultural sensitivity, a greater capacity for clinical problem solving, and an improved sense of self-satisfaction or professional satisfaction. However, these activities involve several ethical challenges. Addressing these challenges is critical to protecting patient welfare in all geographic locales, promoting fair and equitable care globally, and maintaining trust in the profession. This paper describes 5 core positions that focus on ethics and the clinical care context and provides case scenarios to illustrate them.
Joint Commission journal on quality and patient safety, 2017
Conferences, processes, and/or meetings in which adverse events and near misses are reviewed with... more Conferences, processes, and/or meetings in which adverse events and near misses are reviewed within clinical programs at a single academic medical center were identified. Leaders of conferences, processes, or meetings-"process leaders"-in which adverse events and near misses were reviewed were surveyed. On the basis of responses from all 45 process leaders, processes were classified into (1) Morbidity and Mortality Conferences (MMCs), (2) Quality Assurance (QA) Meetings, and (3) Educational Conferences. Some 22% of the clinical programs used more than one of these three processes to identify and review adverse events and near misses, while 10% had no consistent participation in any of them. Explicit criteria for identifying and selecting cases to be reviewed were used by 58% of MMCs and 69% of QA Meetings. The explicit criteria used by MMCs and QA Meetings varied widely. Many MMCs (54%, 13/24), QA Meetings (54%, 7/13), and Educational Conferences (70%, 7/10) did not review...
; for a Task Force of the Association of Bioethics Program Directors* Background: The coronavirus... more ; for a Task Force of the Association of Bioethics Program Directors* Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies.
There are more than 300 known red blood cell (RBC) antigens and 33 platelet antigens that differ ... more There are more than 300 known red blood cell (RBC) antigens and 33 platelet antigens that differ between individuals. Sensitisation to antigens is a serious complication that can occur in prenatal medicine and after blood transfusion, particularly for patients who require multiple transfusions. Although pre-transfusion compatibility testing largely relies on serological methods, reagents are not available for many antigens. Methods based on single-nucleotide polymorphism (SNP) arrays have been used, but typing for ABO and Rh-the most important blood groups-cannot be done with SNP typing alone. We aimed to develop a novel method based on whole-genome sequencing to identify RBC and platelet antigens. This whole-genome sequencing study is a subanalysis of data from patients in the whole-genome sequencing arm of the MedSeq Project randomised controlled trial (NCT01736566) with no measured patient outcomes. We created a database of molecular changes in RBC and platelet antigens and devel...
Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees... more Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals, and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy. To examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization (ACO). Block randomized controlled trial for 1 year. A total of 1205 fully licensed clinicians (728 primary care, 477 specialists). Starting January 2014, clinicians in the Control arm received no price display; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record. Internal prices were the amounts paid by insurers for the ACO's services; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers. Ordering rates (orders per 100 face-to-face encount...
Ordering rates for imaging studies and procedures may change if clinicians are shown the prices o... more Ordering rates for imaging studies and procedures may change if clinicians are shown the prices of those tests while they are ordering. We studied the effect of 2 forms of paid price information, single median price and paired internal/external median prices, on how often pediatric-focused and adult-oriented clinicians (most frequently general pediatricians and adult specialists caring for pediatric-aged patients, respectively) order imaging studies and procedures for 0- to 21-year-olds. In January 2014, we randomized 227 pediatric-focused and 279 adult-oriented clinicians to 1 of 3 study arms: Control (no price display), Single Median Price, or Paired Internal/External Median Prices (both with price display in the ordering screen of electronic health record). We used 1-way analysis of variance and paired t tests to examine how frequently clinicians (1) placed orders and (2) designated tests to be completed internally within an accountable care organization. For pediatric-focused cl...
The impacts of direct-to-consumer personal genomic testing (PGT) on health behaviors such as diet... more The impacts of direct-to-consumer personal genomic testing (PGT) on health behaviors such as diet and exercise are poorly understood. Our investigation aimed to evaluate diet and exercise changes following PGT and to determine if changes were associated with genetic test results obtained from PGT. Customers of 23andMe and Pathway Genomics completed a web-based survey prior to receiving PGT results (baseline) and 6 months post-results. Fruit and vegetable intake (servings/day), and light, vigorous and strength exercise frequency (days/week) were assessed. Changes in diet and exercise were examined using paired t-tests and linear regressions. Additional analyses examined whether outcomes differed by baseline self-reported health (SRH) or content of PGT results. Longitudinal data were available for 1,002 participants. Significant increases were observed for vegetable intake (mean Δ = 0.11 (95% CI = 0.05, 0.17), p = 0.0003) and strength exercise (Δ = 0.14 (0.03, 0.25), p = 0.0153). When...
Aim: To evaluate patients’ expectations regarding the perceived utility of whole-genome sequencin... more Aim: To evaluate patients’ expectations regarding the perceived utility of whole-genome sequencing (WGS). Materials & methods: We used latent class analysis to characterize individuals enrolled in the MedSeq Project based on their perceived utility of WGS. Multinomial logistic regression was used to evaluate associations between participant characteristics and latent classes. Results: Findings characterized participants into one of three perceived utility groups: enthusiasts, who had a high probability of agreement with all utility items (23%); health conscious, who perceived utility in medically related areas (60%) or skeptics, who had a low probability of agreement with utility items (17%). Trust significantly predicted latent class. Conclusion: Understanding differences in perceived utility of WGS may inform strategies for uptake of this technology.
Researchers' obligations to disclose genetic incidental findings (GIFs) have been widely debated,... more Researchers' obligations to disclose genetic incidental findings (GIFs) have been widely debated, but there has been little empirical study of the engagement of institutional review boards (IRBs) with this issue. Methods: This article presents data from the first extensive (n = 796) national survey of IRB professionals' understanding of, experience with, and beliefs surrounding GIFs. Results: Most respondents had dealt with questions about GIFs (74%), but only a minority (47%) felt prepared to address them. Although a majority believed that there is an obligation to disclose GIFs (78%), there is still not consensus about the supporting ethical principles. Respondents generally did not endorse the idea that researchers' additional time and effort (7%), and lack of resources (29%), were valid reasons for diminishing a putative obligation. Most (96%) supported a right not to know, but this view became less pronounced (63%) when framed in terms of specific case studies. Conclusions: IRBs are actively engaged with GIFs but have not yet reached consensus. Respondents were uncomfortable with arguments that could be used to limit an obligation to return GIFs. This could indicate that IRBs are providing some of the impetus for the trend toward returning GIFs, although questions remain about the relative contribution of other stakeholders.
Aim: To describe practicing physicians’ perceived clinical utility of genome sequencing. Material... more Aim: To describe practicing physicians’ perceived clinical utility of genome sequencing. Materials & methods: We conducted a mixed-methods analysis of data from 18 primary care physicians and cardiologists in a study of the clinical integration of whole-genome sequencing. Physicians underwent brief genomics continuing medical education before completing surveys and semi-structured interviews. Results: Physicians described sequencing as currently lacking clinical utility because of its uncertain interpretation and limited impact on clinical decision-making, but they expressed the idea that its clinical integration was inevitable. Potential clinical uses for sequencing included complementing other clinical information, risk stratification, motivating patient behavior change and pharmacogenetics. Conclusion: Physicians given genomics continuing medical education use the language of both evidence-based and personalized medicine in describing the utility of genome-wide testing in patient...
As more research studies incorporate next-generation sequencing (including whole-genome or whole-... more As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants' health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles.
The Human Genome Project continues to produce an increasing number of genetic susceptibility test... more The Human Genome Project continues to produce an increasing number of genetic susceptibility tests. Some of these genetic tests target social or ethnic groups who are at increased risk of developing a disease. The Ashkenazi Jewish community is one ethnic group that is an ongoing subject of genetic investigation. We assessed the attitudes of a population-based sample of Ashkenazi Jewish women toward breast-ovarian cancer susceptibility testing (BRCA1/2). In particular, we assessed concerns about group discrimination, perceptions of the advantages and disadvantages of BRCA1/2 testing, and the relationship between concerns about discrimination and the potential benefits of genetic testing. Methods: A telephone survey of a population-based sample of 200 Jewish women. Results: A minority of women (17%) in this study expressed concern or discomfort with Jews being offered BRCA1/2 testing. Most women believed there were scientific reasons for testing Jews (71%), and only 5% of women felt that research that focused on Jews was bad for Jews as a group. Increased concern about genetic discrimination was associated with women who were highly educated (odds ratio 2.68). Forty percent of women surveyed were interested in BRCA1/2 testing, 40% were not interested, and 20% were uncertain about whether they would obtain BRCA1/2 testing. Increased interest in genetic testing was associated with a desire to obtain information about children's risk of disease and valuing information for its own sake. Conclusions: The majority of a population-based sample of Jewish women did not express concerns about group discrimination resulting from genetic testing. Women who are highly educated are more concerned about genetic discrimination. There is significant variation among Jewish women's interest in breast cancer susceptibility testing.
As patients with genetic diseases seek to have healthy biologically connected children, they will... more As patients with genetic diseases seek to have healthy biologically connected children, they will undoubtedly turn to trusted health care professionals for guidance. "Doctor, should I enter a clinical trial to edit my embryos?" is likely to become a query posed by patients with genetic illnesses. Physicians need both empathic communication skills and a framework for responding to this question. Applying the 4-S framework to gene editing can guide clinicians' responses to patients' CRISPR queries by facilitating discussion of (1) safety, (2) significance of harm to be averted, (3) impact on succeeding generations, and (4) social consequences. Case Dr H assists reproduction for couples who desire biological children. Ms A has struggled throughout her life to cope with a rare X-linked disease, so Dr H recommended genetic counseling. Ms A and her husband learned that their offspring would inherit at least one pathogenic allele without intervention. Ms A remains adamant about not passing on a pathogenic variant to a child.
Aim: Describe the characteristics of providers ordering, patients receiving, and clinical impact ... more Aim: Describe the characteristics of providers ordering, patients receiving, and clinical impact of a psychotropic pharmacogenetic test on veteran care. Patients & methods: Observational cohort study linking veterans' laboratory results to electronic health record data. Changes in psychotropic medication prescribing were measured as a function of test results. Results: A total of 38 providers tested 181 veterans between 10/6/2014 and 2/1/2018. Prescriptions for medications with severe gene–drug interactions decreased; however, 11 such medications were used after testing. For 43 patients, documentation of the results was missing. Conclusion: Most prescribing decisions were congruent with test results, but in a nontrivial number of cases, prescribers appeared not to act on the results. Poor result documentation impeded the potential of results to inform clinical care.
IMPORTANCE Transparency of industry payments to physicians could engender greater public trust in... more IMPORTANCE Transparency of industry payments to physicians could engender greater public trust in physicians but might also lead to greater mistrust of physicians and the medical profession, adversely affecting the patient-physician relationship. OBJECTIVE To examine the association between nationwide public disclosure of industry payments and Americans' trust in their physicians and trust in the medical profession. DESIGN, SETTING, AND PARTICIPANTS Survey study using difference-indifference analyses of a national longitudinal survey comparing changes in states where industry payments were newly disclosed by Open Payments with changes in states where payments information was already available because of state sunshine laws. The US population-based surveys were conducted in September 2014-shortly before the initial public disclosure of industry payments-and again in September 2016. Final analyses were conducted September through December 2018. Participants were adults 18 years and older (n = 1388). EXPOSURES National public disclosure through Open Payments of payments made by pharmaceutical and medical device firms to physicians. MAIN OUTCOMES AND MEASURES Wake Forest measure of trust in one's own physician and Wake Forest measure of trust in the medical profession. RESULTS Of the 3542 original survey respondents, 2180 (61.5%) completed the second survey 2 years later, and 1388 named the same most frequently seen physician in both surveys. The mean age of respondents at the time of the first survey was 53 years, and 749 (54.0%) were women. Race/ ethnicity was white in 76.6% (1063 of 1388) and non-Hispanic black in 8.0% (111 of 1388). Public disclosure of payments was associated with lower trust in one's own physician regardless of whether respondents knew their physicians had received payments (decrease in Wake Forest measure of trust in one's own physician of 0.56 point; 95% CI, −0.79 to −0.32 point; P < .001). Open Payments was also associated with lower trust in the medical profession (decrease in Wake Forest measure of trust in the medical profession of 0.35 point; 95% CI, −0.58 to −0.12 point; P = .004). CONCLUSIONS AND RELEVANCE Nationwide public disclosure of industry payments may be associated with decreased trust in physicians and in the medical profession. More judicious presentation of payments information may counteract unintended negative trust and spillover consequences of public disclosure.
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Papers by Lisa Lehmann