Publications by authors named "M Benjamin Nelson"

4,590 Publications

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The patient's medication access journey: a conceptual framework focused beyond adherence.

J Manag Care Spec Pharm 2021 Dec;27(12):1627-1635

Pharmacy Quality Alliance, Alexandria, VA.

It is well known that medication accessibility reduces morbidity and mortality and increases health-related quality of life; however, despite efforts to improve health care access, many Americans still face challenges in accessing medications. Several health care access and utilization conceptual frameworks have been created and used for decades to illustrate key relationships and interdependencies between elements of the system. However, none of these frameworks have focused exclusively on medication access and associated factors. Medication access is a complex, multidimensional issue that must consider not only patient-specific challenges, but also health system limitations, among others. A better understanding of medication access, beyond the proxy marker of adherence, is needed to identify opportunities to improve accessibility. To develop a conceptual framework that defines a patient's medication access journey and characterizes barriers frequently encountered while seeking medication access. A multistakeholder roundtable composed of 15 experts from across the health care continuum was convened in 2018 by the Pharmacy Quality Alliance to develop a conceptual framework for medication access. The roundtable participants were convened through in-person and telephonic meetings. To inform their work, 2 literature reviews and an environmental scan were conducted to identify medication access barriers, interventions affecting medication access, and medication access quality measures. The resulting framework included 7 nodes that represent the major access points encountered by patients when attempting to access medications: perceived need, help seeking, encounter, prescribing, prescription adjudication, prescription dispensing, and adherence. Also, 18 barriers were identified. Patient health literacy, cost, insurance, and organizational health literacy were predominant barriers across multiple nodes. The framework that was developed provides a patient-focused, holistic view of medication access, incorporating access nodes and corresponding barriers. It also provides a structure to consider key opportunities for interventions and measurement to address medication access challenges. This study was conducted with grant support from the National Pharmaceutical Council, which served as a collaborator in the study. Westrich is employed by the National Pharmaceutical Council. Nelson is employed by the Pharmacy Quality Alliance, which was contracted to conduct this study. Pickering, Campbell, and Holland were employed by the Pharmacy Quality Alliance at the time of this study. This research was presented as a professional poster at the American Public Health Association Annual Meeting in October 2019, Philadelphia, PA.
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http://dx.doi.org/10.18553/jmcp.2021.27.12.1627DOI Listing
December 2021

Economic Outcomes of Rehabilitation Therapy in Older Patients With Acute Heart Failure in the REHAB-HF Trial: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Cardiol 2021 Nov 24. Epub 2021 Nov 24.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Importance: In the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial, a novel 12-week rehabilitation intervention demonstrated significant improvements in validated measures of physical function, quality of life, and depression, but no significant reductions in rehospitalizations or mortality compared with a control condition during the 6-month follow up. The economic implications of these results are important given the increasing pressures for cost containment in health care.

Objective: To report the economic outcomes of the REHAB-HF trial and estimate the potential cost-effectiveness of the intervention.

Design, Setting, Participants: The multicenter REHAB-HF trial randomized 349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019. For this preplanned secondary analysis of the economic outcomes, data on medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities) were collected. Medical resource use and medication costs were estimated using 2019 US Medicare payments and the Federal Supply Schedule, respectively. Cost-effectiveness was estimated using the validated Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, which uses an individual-patient simulation model informed by the prospectively collected trial data. Data were analyzed from March 24, 2019, to December 1, 2020.

Interventions: Rehabilitation intervention or control.

Main Outcomes And Measures: Costs, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio).

Results: Among the 349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6%]), mean (SD) cumulative costs per patient were $26 421 ($38 955) in the intervention group (excluding intervention costs) and $27 650 ($30 712) in the control group (difference, -$1229; 95% CI, -$8159 to $6394; P = .80). The mean (SD) cost of the intervention was $4204 ($2059). Quality of life gains were significantly greater in the intervention vs control group during 6 months (mean utility difference, 0.074; P = .001) and sustained beyond the 12-week intervention. Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.

Conclusions And Relevance: These analyses suggest that longer-term benefits of this novel rehabilitation intervention, particularly in the subgroup of patients with preserved ejection fraction, may yield good value to the health care system. However, long-term cost-effectiveness is currently uncertain and dependent on the assumption that benefits are sustained beyond study follow-up, which needs to be corroborated in future trials in this patient population.
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http://dx.doi.org/10.1001/jamacardio.2021.4836DOI Listing
November 2021

Factors associated with relapse-free survival after neoadjuvant chemotherapy for breast cancer at a safety net medical center.

Am J Surg 2021 Nov 16. Epub 2021 Nov 16.

Los Angeles County + University of Southern California (LAC+USC) Medical Center, Los Angeles, CA, USA; Department of Surgery and Norris Comprehensive Cancer Center, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, USA. Electronic address:

Background: This study was designed to assess prognostic factors associated with relapse-free survival (RFS) after neoadjuvant chemotherapy (NAC) for breast cancer.

Methods: A single-institution retrospective analysis was performed including clinical, radiographic, and pathologic parameters for all breast cancer patients treated with NAC from 2015 to 2018. All patients had pre-and post-NAC MRI.

Results: For 102 patients, median follow-up was 47.4 months, and the five-year RFS was 74%. The 41 (40%) patients who achieved pathologic complete response (pCR) after NAC had a significantly higher five-year RFS than the 61 not achieving pCR. For 31 patients with triple-negative cancers, the five-year RFS was significantly higher in those achieving pCR vs. no pCR. The 44 (43%) patients who achieved radiographic complete response (rCR) after NAC had similar five-year RFS to the 58 (57%) not achieving rCR.

Conclusion: pCR, node-negativity after NAC, and triple-negative subtype were prognostic factors associated with relapse-free survival after NAC.
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http://dx.doi.org/10.1016/j.amjsurg.2021.11.017DOI Listing
November 2021

SARS-CoV-2 infection in free-ranging white-tailed deer ( ).

bioRxiv 2021 Nov 5. Epub 2021 Nov 5.

Human-to-animal spillover of SARS-CoV-2 virus has occurred in a wide range of animals, but thus far, the establishment of a new natural animal reservoir has not been detected. Here, we detected SARS-CoV-2 virus using rRT-PCR in 129 out of 360 (35.8%) free-ranging white-tailed deer ( ) from northeast Ohio (USA) sampled between January-March 2021. Deer in 6 locations were infected with at least 3 lineages of SARS-CoV-2 (B.1.2, B.1.596, B.1.582). The B.1.2 viruses, dominant in Ohio at the time, spilled over multiple times into deer populations in different locations. Deer-to-deer transmission may have occurred in three locations. The establishment of a natural reservoir of SARS-CoV-2 in white-tailed deer could facilitate divergent evolutionary trajectories and future spillback to humans, further complicating long-term COVID-19 control strategies.

One-sentence Summary: A significant proportion of SARS-CoV-2 infection in free-ranging US white-tailed deer reveals a potential new reservoir.
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http://dx.doi.org/10.1101/2021.11.04.467308DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597885PMC
November 2021

Population genomic screening of young adults for familial hypercholesterolaemia: a cost-effectiveness analysis.

Eur Heart J 2021 Nov 11. Epub 2021 Nov 11.

School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, Melbourne, VIC 3004, Australia.

Aims: The aim of this study was to assess the impact and cost-effectiveness of offering population genomic screening to all young adults in Australia to detect heterozygous familial hypercholesterolaemia (FH).

Methods And Results: We designed a decision analytic Markov model to compare the current standard of care for heterozygous FH diagnosis in Australia (opportunistic cholesterol screening and genetic cascade testing) with the alternate strategy of population genomic screening of adults aged 18-40 years to detect pathogenic variants in the LDLR/APOB/PCSK9 genes. We used a validated cost-adaptation method to adapt findings to eight high-income countries. The model captured coronary heart disease (CHD) morbidity/mortality over a lifetime horizon, from healthcare and societal perspectives. Risk of CHD, treatment effects, prevalence, and healthcare costs were estimated from published studies. Outcomes included quality-adjusted life years (QALYs), costs and incremental cost-effectiveness ratio (ICER), discounted 5% annually. Sensitivity analyses were undertaken to explore the impact of key input parameters on the robustness of the model. Over the lifetime of the population (4 167 768 men; 4 129 961 women), the model estimated a gain of 33 488years of life lived and 51 790 QALYs due to CHD prevention. Population genomic screening for FH would be cost-effective from a healthcare perspective if the per-test cost was ≤AU$250, yielding an ICER of
Conclusion: Based on our model, offering population genomic screening to all young adults for FH could be cost-effective, at testing costs that are feasible.
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http://dx.doi.org/10.1093/eurheartj/ehab770DOI Listing
November 2021
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