Policies and practices of data-intensive primary care in the precision-medicine era

The standard approach to protecting privacy in healthcare aims to control access to personal information. We cannot regain control of information after it has been shared, so we must restrict access from the start. This ‘control’ conception of privacy conflicts with data-intensive initiatives like precision medicine and learning health systems, as they require patients to give up significant control of their information. Without adequate alternatives to the control-based approach, such data-intensive programmes appear to require a loss of privacy. This paper argues that the control view of privacy is shortsighted and overlooks important ways to protect health information even when widely shared. To prepare for a world where we no longer control our data, we must pursue three alternative strategies: obfuscate health data, penalise the misuse of health data and improve transparency around who shares our data and for what purposes. Prioritising these strategies is necessary when health data are widely shared both within and outside of the health system.

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Economic burden of not testing for FLT3 to treat acute myeloid leukemia.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e13652 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e13652-e13652

Author(s):

Raymond Henderson ◽

Dave Smart ◽

Declan French ◽

Jordan Clark ◽

Kenneth Joel Bloom ◽

...

Keyword(s):

Primary Care ◽

Acute Myeloid Leukemia ◽

Precision Medicine ◽

Economic Burden ◽

Myeloid Leukemia ◽

Life Years ◽

Illness Study ◽

Survival After Relapse ◽

Medicare Patients ◽

Acute Myeloid

e13652 Background: Acute myeloid leukemia (AML) is a hematologic neoplasm with poor 5-year survival (33%; US 2016), a median survival of only 4 months for relapsed/refractory cases, and in 2016, a US incidence of 19,950 cases and 10,340 deaths. With the largest patient cohort over 65, AML treatment costs in the first year are > $25,000 per patient per month (PPPM); the initial month’s cost is $82,328. Mutations in the FMS-like tyrosine kinase 3 ( FLT3+) pathway confer resistance to standard chemotherapy and reduce the likelihood of survival after relapse. In 2017 and 2018, the FDA approved midostaurin and gilteritinib, two current FLT3+ precision medicines for AML. Here, we determine the economic burden of not testing for FLT3+. Methods: AML healthcare costs were assessed and modelled for the following settings: hospital, outpatient, emergency, and primary care. Pharmaceutical activity and cost data were extracted from the Centers for Medicare and Medicaid Services (CMS) database, employing Diaceutics’ proprietary Global Diagnostic Index. Our model forecasts the economic impact of precision testing to guide FLT3+ precision medicines in 2017 through 2019. Our algorithm calculates the number of AML patients with FLT3+ based on AML Medicare patients in the Healthcare Cost and Utilization Project database and FLT3+ prevalence and switching data. Results: Total US 2016 AML costs were $1.574 billion (bn), consisting of (i) hospital care $1 bn (including $229 million (mn) for bone marrow transplantation and $20.5 mn for pharmaceuticals); (ii) outpatient care $9.8 mn; (iii) emergency care $553.9 mn; (iv) primary care $6.6 mn. Analysis of CMS data revealed a paucity of FLT3+ testing to guide therapy. We estimate that after testing, 2,164 FLT3+ Medicare patients could benefit from precision medicine interventions, generating 2,965 quality-adjusted life years (QALYs) or 2,783 QALYs when administering midostaurin or gilteritinib respectively. Conclusions: This study is the most detailed analysis of the economic burden of AML among US Medicare patients to date and is the only AML cost-of-illness study to incorporate data concerning patients’ QALYs lost by failure to employ precision medicine. This study not only illustrates the minimal FLT3 testing conducted, but also the lack of precision medicines administered.

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When information is the treatment? Precision medicine in healthcare

Healthcare Management Forum ◽

10.1177/0840470419859017 ◽

2019 ◽

Vol 33 (3) ◽

pp. 120-125

Author(s):

Michael Beauvais ◽

Bartha Maria Knoppers

Keyword(s):

Precision Medicine ◽

Conventional Medicine ◽

Healthcare Management ◽

Court Cases ◽

Informational Needs ◽

Data Intensive ◽

Privacy Law ◽

Privacy Laws ◽

New Challenges ◽

Regulatory Barriers

Profoundly more data-intensive than conventional medicine, precision medicine’s distinctive informational needs present new challenges for healthcare management. Data protection and privacy law are key determinants in precision medicine’s future. This article examines legal and regulatory barriers to the incorporation of precision medicine into healthcare. Specific attention is paid to analyzing recent health privacy laws, court cases, and medical device regulations. Considering the challenges identified, recommendations and guidance are crafted for health leaders with reference to domestic and international initiatives.

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Record linkage under suboptimal conditions for data-intensive evaluation of primary care in Rio de Janeiro, Brazil

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-021-01550-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Claudia Medina Coeli ◽

Valeria Saraceni ◽

Paulo Mota Medeiros ◽

Helena Pereira da Silva Santos ◽

Luis Carlos Torres Guillen ◽

...

Keyword(s):

Primary Care ◽

Record Linkage ◽

Gold Standard ◽

Rio De Janeiro ◽

Social Benefits ◽

Mortality Data ◽

Care Hospital ◽

Data Intensive ◽

False Match

Abstract Background Linking Brazilian databases demands the development of algorithms and processes to deal with various challenges including the large size of the databases, the low number and poor quality of personal identifiers available to be compared (national security number not mandatory), and some characteristics of Brazilian names that make the linkage process prone to errors. This study aims to describe and evaluate the quality of the processes used to create an individual-linked database for data-intensive research on the impacts on health indicators of the expansion of primary care in Rio de Janeiro City, Brazil. Methods We created an individual-level dataset linking social benefits recipients, primary health care, hospital admission and mortality data. The databases were pre-processed, and we adopted a multiple approach strategy combining deterministic and probabilistic record linkage techniques, and an extensive clerical review of the potential matches. Relying on manual review as the gold standard, we estimated the false match (false-positive) proportion of each approach (deterministic, probabilistic, clerical review) and the missed match proportion (false-negative) of the clerical review approach. To assess the sensitivity (recall) to identifying social benefits recipients’ deaths, we used their vital status registered on the primary care database as the gold standard. Results In all linkage processes, the deterministic approach identified most of the matches. However, the proportion of matches identified in each approach varied. The false match proportion was around 1% or less in almost all approaches. The missed match proportion in the clerical review approach of all linkage processes were under 3%. We estimated a recall of 93.6% (95% CI 92.8–94.3) for the linkage between social benefits recipients and mortality data. Conclusion The adoption of a linkage strategy combining pre-processing routines, deterministic, and probabilistic strategies, as well as an extensive clerical review approach minimized linkage errors in the context of suboptimal data quality.

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Evaluating Primary Care Providers’ Readiness for Delivering Genetic and Genomic Services to Underserved Populations

Public Health Genomics ◽

10.1159/000518415 ◽

2021 ◽

pp. 1-10

Author(s):

Yashoda Sharma ◽

Livia Cox ◽

Lucie Kruger ◽

Veena Channamsetty ◽

Susanne B. Haga

Keyword(s):

Primary Care ◽

Precision Medicine ◽

Health Center ◽

Underserved Populations ◽

Care Delivery ◽

Primary Care Providers ◽

Clinical Genetics ◽

Care Providers ◽

Genetic Tests ◽

Genetics And Genomics

Introduction: Increased genomics knowledge and access are advancing precision medicine and care delivery. With the translation of precision medicine across health care, genetics and genomics will play a greater role in primary care services. Health disparities and inadequate representation of racial and ethnically diverse groups threaten equitable access for those historically underserved. Health provider awareness, knowledge, and perceived importance are important determinants of the utilization of genomic applications. Methods: We evaluated the readiness of primary care providers at a Federally Qualified Health Center, the Community Health Center, Inc. (CHCI) for delivering genetic and genomic testing to underserved populations. Online survey questions focused on providers’ education and training in basic and clinical genetics, familiarity with current genetic tests, and needs for incorporating genetics and genomics into their current practice. Results: Fifty of 77 (65%) primary care providers responded to the survey. Less than half received any training in basic or clinical genetics (40%), were familiar with specific genetic tests (36%), or felt confident with collecting family health history (44%), and 70% believed patients would benefit from genetic testing. Conclusion: Despite knowledge gaps, respondents recognized the value and need to bring these services to their patients, though would like more education on applying genetics and genomics into their practice, and more training about discussing risk factors associated with race or ethnicity. We provide further evidence of the need for educational resources and standardized guidelines for providers caring for underserved populations to optimize appropriate use and referral of genetic and genomic services and to reduce disparities in care.

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Perspectives in Primary Care: Knowing the Patient as a Person in the Precision Medicine Era

The Annals of Family Medicine ◽

10.1370/afm.2169 ◽

2018 ◽

Vol 16 (1) ◽

pp. 4-5 ◽

Cited By ~ 3

Author(s):

Roy C. Ziegelstein

Keyword(s):

Primary Care ◽

Precision Medicine

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Perspectives on Precision Medicine in a Tribally Managed Primary Care Setting

AJOB Empirical Bioethics ◽

10.1080/23294515.2020.1817172 ◽

2020 ◽

Vol 11 (4) ◽

pp. 246-256 ◽

Cited By ~ 1

Author(s):

Julie A. Beans ◽

R. Brian Woodbury ◽

Kyle A. Wark ◽

Vanessa Y. Hiratsuka ◽

Paul Spicer

Keyword(s):

Primary Care ◽

Precision Medicine ◽

Care Setting ◽

Primary Care Setting

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At the intersection of precision medicine and population health: an implementation-effectiveness study of family health history based systematic risk assessment in primary care

BMC Health Services Research ◽

10.1186/s12913-020-05868-1 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lori A. Orlando ◽

R. Ryanne Wu ◽

Rachel A. Myers ◽

Joan Neuner ◽

Catherine McCarty ◽

...

Keyword(s):

Risk Assessment ◽

Primary Care ◽

Precision Medicine ◽

Disease Risk ◽

Systematic Risk ◽

Family Health ◽

Family Health History ◽

Implementation Effectiveness ◽

Primary Care Population ◽

Health History

Abstract Background Risk assessment is a precision medicine technique that can be used to enhance population health when applied to prevention. Several barriers limit the uptake of risk assessment in health care systems; and little is known about the potential impact that adoption of systematic risk assessment for screening and prevention in the primary care population might have. Here we present results of a first of its kind multi-institutional study of a precision medicine tool for systematic risk assessment. Methods We undertook an implementation-effectiveness trial of systematic risk assessment of primary care patients in 19 primary care clinics at four geographically and culturally diverse healthcare systems. All adult English or Spanish speaking patients were invited to enter personal and family health history data into MeTree, a patient-facing family health history driven risk assessment program, for 27 medical conditions. Risk assessment recommendations followed evidence-based guidelines for identifying and managing those at increased disease risk. Results One thousand eight hundred eighty-nine participants completed MeTree, entering information on N = 25,967 individuals. Mean relatives entered = 13.7 (SD 7.9), range 7–74. N = 1443 (76.4%) participants received increased risk recommendations: 597 (31.6%) for monogenic hereditary conditions, 508 (26.9%) for familial-level risk, and 1056 (56.1%) for risk of a common chronic disease. There were 6617 recommendations given across the 1443 participants. In multivariate analysis, only the total number of relatives entered was significantly associated with receiving a recommendation. Conclusions A significant percentage of the general primary care population meet criteria for more intensive risk management. In particular 46% for monogenic hereditary and familial level disease risk. Adopting strategies to facilitate systematic risk assessment in primary care could have a significant impact on populations within the U.S. and even beyond. Trial registration Clinicaltrials.gov number NCT01956773, registered 10/8/2013.

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Abstract 070: A Precision Medicine Test Influenced Costs of Care Among Patients Presenting With Stable Symptoms Suggestive of Obstructive Coronary Artery Disease: Economic Endpoint Analysis From the PRESET Registry

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.10.suppl_3.070 ◽

2017 ◽

Vol 10 (suppl_3) ◽

Author(s):

Joseph Ladapo ◽

Matthew Budoff ◽

David Sharp ◽

Pejman Azarmina ◽

Lin Huang ◽

...

Keyword(s):

Primary Care ◽

Coronary Artery Disease ◽

Coronary Artery ◽

Precision Medicine ◽

Obstructive Coronary Artery Disease ◽

Cost Of Care ◽

Luminal Diameter ◽

Patient Demographics ◽

Artery Disease

Background: Because of diagnostic uncertainty, patients with symptoms suggestive of obstructive coronary artery disease (CAD) are referred at high rates to cardiologists and advanced cardiac testing. This evaluation process may also expose patients to appreciable costs and health risks. A previously validated, blood-based test incorporating age, sex and genomic expression into an algorithmic score (1-40) has shown clinical validity in assessing the likelihood of obstructive CAD (≥50% luminal diameter stenosis by quantitative coronary angiography) early in the cardiac workup. This test has also shown clinical utility in association with decision making around cardiac referrals and helping clinicians determine the current likelihood of obstructive CAD in symptomatic patients. Hypothesis: We hypothesized that use of the age/sex/gene expression score (ASGES) test would influence cost of care in the diagnosis and management of symptomatic patients with suspected obstructive CAD. Methods: The prospective PRESET Registry (NCT01677156) enrolled stable, non-acute adult patients presenting with symptoms suggestive of obstructive CAD to 21 US primary care practices from September 2012 to August 2014. Primary care clinicians provided pre- and post-ASGES diagnosis and evaluation plans for each patient. Demographics, clinical factors, and ASGES results (predefined as low [ASGES ≤ 15] or elevated [ASGES > 15]) were collected, as were management plans post-ASGES testing, including referrals to cardiology or further functional/anatomic testing. The economic analysis for cost of care after ASGES testing was based on the cost of cardiovascular-related tests, invasive procedures, office visits, emergency room visits, and hospital admissions during 1-year follow-up. Results: This sub-analysis cohort included 560 patients, with 50% females and median age 56 years. Patients had a median ASGES score of 18, with 246 (44%) patients with ASGES < 15. The mean cost of care for patients in the year following ASGES testing was $234 (SD ±$707) in the low ASGES versus $1,296 (SD ±$5230) in the elevated ASGES group (p=0.03 by Wilcoxon rank test). Multivariate analysis incorporating patient demographics and clinical covariates showed that low ASGES was associated with a 51% reduction in cost of follow-up care compared to elevated ASGES group (p<0.001 by log-linear regression). Conclusion: In this community-based cardiovascular registry, the ASGES influenced costs in the evaluation of patients with suspected obstructive CAD. Low score patients had approximately half the cardiovascular costs of elevated score patients in one year follow-up. Our work provides evidence supporting the economic value of using precision medicine in the delivery of cardiovascular care.

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