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Pharmacogenomics in diverse practice settings: implementation beyond major metropolitan areas.

ABSTRACT: The limited formal study of the clinical feasibility of implementing pharmacogenomic tests has thus far focused on providers at large medical centers in urban areas. Our research focuses on small metropolitan, rural and tribal practice settings.We interviewed 17 healthcare providers in western Montana regarding pharmacogenomic testing.Participants were optimistic about the potential of pharmacogenomic tests, but noted unique barriers in small and rural settings including cost, adherence, patient acceptability and testing timeframe. Participants in tribal settings identified heightened sensitivity to genetics and need for community leadership approval as additional considerations.Implementation differences in small metropolitan, rural and tribal communities may affect pharmacogenomic test adoption and utilization, potentially impacting many patients. Original submitted 3 September 2014; Revision submitted 3 December 2014.

SUBMITTER: Dorfman EH

PROVIDER: S-EPMC4360986 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Pharmacogenomics in diverse practice settings: implementation beyond major metropolitan areas.

Dorfman Elizabeth H EH Brown Trinidad Susan S Morales Chelsea T CT Howlett Kevin K Burke Wylie W Woodahl Erica L EL

Pharmacogenomics 20150101 3

<h4>Aim</h4>The limited formal study of the clinical feasibility of implementing pharmacogenomic tests has thus far focused on providers at large medical centers in urban areas. Our research focuses on small metropolitan, rural and tribal practice settings.<h4>Materials & methods</h4>We interviewed 17 healthcare providers in western Montana regarding pharmacogenomic testing.<h4>Results</h4>Participants were optimistic about the potential of pharmacogenomic tests, but noted unique barriers in sma ...[more]

PMID: 25712186

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Project description:Considerable efforts have been exerted to implement Pharmacogenomics (PGx), the study of interindividual variations in DNA sequence related to drug response, into routine clinical practice. In this article, we first briefly describe PGx and its role in improving treatment outcomes. We then propose an approach to initiate clinical PGx in the hospital setting. One should first evaluate the available PGx evidence, review the most relevant drugs, and narrow down to the most actionable drug-gene pairs and related variant alleles. This is done based on data curated and evaluated by experts such as the pharmacogenomics knowledge implementation (PharmGKB) and the Clinical Pharmacogenetics Implementation Consortium (CPIC), as well as drug regulatory authorities such as the US Food and Drug Administration (FDA) and European Medicinal Agency (EMA). The next step is to differentiate reactive point of care from preemptive testing and decide on the genotyping strategy being a candidate or panel testing, each of which has its pros and cons, then work out the best way to interpret and report PGx test results with the option of integration into electronic health records and clinical decision support systems. After test authorization or testing requirements by the government or drug regulators, putting the plan into action involves several stakeholders, with the hospital leadership supporting the process and communicating with payers, the pharmacy and therapeutics committee leading the process in collaboration with the hospital laboratory and information technology department, and healthcare providers (HCPs) ordering the test, understanding the results, making the appropriate therapeutic decisions, and explaining them to the patient. We conclude by recommending some strategies to further advance the implementation of PGx in practice, such as the need to educate HCPs and patients, and to push for more tests' reimbursement. We also guide the reader to available PGx resources and examples of PGx implementation programs and initiatives.

Project description:ImportanceWhile variations in quality of care have been described between US regions, physician-level practice pattern variations within regions remain poorly understood, notably among specialists.ObjectiveTo examine within-area physician-level variations in decision-making in common clinical scenarios where guidelines specifying appropriateness or quality of care exist.Design setting and participantsThis cross-sectional study used 2016 through 2019 data from a large nationwide network of commercial insurers, provided by Health Intelligence Company, LLC, within 5 metropolitan statistical areas (MSAs). Physician-level variations in appropriateness and quality of care were measured using 14 common clinical scenarios involving 7 specialties. The measures were constructed using public quality measure definitions, clinical guidelines, and appropriateness criteria from the clinical literature. Physician performance was calculated using a multilevel model adjusted for patient age, sex, risk score, and socioeconomic status with physician random effects. Measure reliability for each physician was calculated using the signal-to-noise approach. Within-MSA variation was calculated between physician quintiles adjusted for patient attributes, with the first quintile denoting highest quality or appropriateness and the fifth quintile reflecting the opposite. Data were analyzed March through October 2021.Main outcomes and measuresFourteen measures of quality or appropriateness of care, with 2 measures each in the domains of cardiology, endocrinology, gastroenterology, pulmonology, obstetrics, orthopedics, and neurosurgery.ResultsA total of 8788 physicians were included across the 5 MSAs, and about 2.5 million unique patient-physician pairs were included in the measures. Within the 5 MSAs, on average, patients in the measures were 34.7 to 40.7 years old, 49.1% to 52.3% female, had a mean risk score of 0.8 to 1.0, and more likely to have an employer-sponsored insurance plan that was either self-insured or fully insured (59.8% to 97.6%). Within MSAs, physician-level variations were qualitatively similar across measures. For example, statin therapy in patients with coronary artery disease ranged from 54.3% to 70.9% in the first quintile of cardiologists to 30.5% to 42.6% in the fifth quintile. Upper endoscopy in patients with gastroesophageal reflux disease without alarm symptoms spanned 14.6% to 16.9% in the first quintile of gastroenterologists to 28.2% to 33.8% in the fifth quintile. Among patients with new knee or hip osteoarthritis, 2.1% to 3.4% received arthroscopy in the first quintile of orthopedic surgeons, whereas 25.5% to 30.7% did in the fifth quintile. Appropriate prenatal screening among pregnant patients ranged from 82.6% to 93.6% in the first quintile of obstetricians to 30.9% to 65.7% in the fifth quintile. Within MSAs, adjusted differences between quintiles approximated unadjusted differences. Measure reliability, which can reflect consistency and reproducibility, exceeded 70.0% across nearly all measures in all MSAs.Conclusions and relevanceIn this cross-sectional study of 5 US metropolitan areas, sizeable physician-level practice variations were found across common clinical scenarios and specialties. Understanding the sources of these variations may inform efforts to improve the value of care.

Project description:Background Rates of major lower extremity amputation in patients with peripheral artery disease are higher in rural communities with markers of low socioeconomic status, but most Americans live in metropolitan areas. Whether amputation rates vary within US metropolitan areas is unclear, as are characteristics of high amputation rate urban communities. Methods and Results We estimated rates of major lower extremity amputation per 100 000 Medicare beneficiaries between 2010 and 2018 at the ZIP code level among ZIP codes with ≥100 beneficiaries. We described demographic characteristics of high and low amputation ZIP codes, and the association between major amputation rate and 3 ZIP code-level markers of socioeconomic status-the proportion of patients with dual eligibility for Medicaid, median household income, and Distressed Communities Index score-for metropolitan, micropolitan, and rural ZIP code cohorts. Between 2010 and 2018, 188 995 Medicare fee-for-service patients living in 31 391 ZIP codes with ≥100 beneficiaries had a major lower extremity amputation. The median (interquartile range) ZIP code-level number of amputations per 100 000 beneficiaries was 262 (75-469). Though nonmetropolitan ZIP codes had higher rates of major amputation than metropolitan areas, 78.2% of patients undergoing major amputation lived in metropolitan areas. Compared with ZIP codes with lower amputation rates, top quartile amputation rate ZIP codes had a greater proportion of Black residents (4.4% versus 17.5%, P<0.001). In metropolitan areas, after adjusting for clinical comorbidities and demographics, every $10 000 lower median household income was associated with a 4.4% (95% CI, 3.9-4.8) higher amputation rate, and a 10-point higher Distressed Communities Index score was associated with a 3.8% (95% CI, 3.4%-4.2%) higher amputation rate; there was no association between the proportion of patients eligible for Medicaid and amputation rate. These findings were comparable to the associations identified across all ZIP codes. Conclusions In metropolitan areas, where most individuals undergoing lower extremity amputation live, markers of lower socioeconomic status and Black race were associated with higher rates of major lower extremity amputation. Development of community-based tools for peripheral artery disease diagnosis and management targeted to communities with high amputation rates in urban areas may help reduce inequities in peripheral artery disease outcomes.

Project description:BACKGROUND:The 'DREAMS Partnership' promotes a multi-sectoral approach to reduce adolescent girls and young women's (AGYW) vulnerability through a core package of interventions targeting multiple sources of HIV risk-to promote Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) lives. Implementation of such multi-sectoral programmes is complex and requires adaptation to national and local contexts. We describe the early implementation of DREAMS in diverse settings, to identify lessons for the scale-up and replication of combination programmes for young people. METHODS:As part of evaluations underway in six DREAMS sites in three countries (Kenya, South Africa and Zimbabwe), we draw on process evaluation data collected from focus group discussions, key informant interviews, and in-depth interviews with beneficiaries, parents/caregivers, programme managers and opinion leaders. Additionally, structured observations were conducted and Gantt charts completed upon consultation with implementers. We concurrently reviewed documentation available on DREAMS and held cross-site discussions to interpret findings. FINDINGS:All sites sought to implement all components of the DREAMS core package, but how and when they were implemented varied by context. Models of delivery differed, with either multiple or single partners responsible for some or all interventions. Key challenges included the urgent and ambitious expectations of DREAMS; 'layering' multiple interventions across different sectors (health, education, social welfare); supporting individuals' journeys between services to improve uptake and retention; engaging communities beyond direct beneficiaries; avoiding perceived/actual exclusivity; and ensuring continuity of commitment and funding for DREAMS. Despite significant challenges, DREAMS was well-received in the communities and perceived by both beneficiaries and implementers to empower AGYW to remain HIV negative. Structures, protocols and tools were introduced to strengthen referrals and deliver services targeted to the age and circumstances of young people. CONCLUSIONS:The benefits of combinations or integrated 'packages' of interventions are increasingly recognised. Early implementation of DREAMS provides useful lessons for improving coordination across multiple partners using a phased, systematic approach, regular adaptions to each unique context, and ensuring community ownership.

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Pharmacogenomics in diverse practice settings: implementation beyond major metropolitan areas.

Publications

Pharmacogenomics in diverse practice settings: implementation beyond major metropolitan areas.

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