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Authors = Gary Gustavsen

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11 pages, 2813 KiB  
Article
Perspectives on Reducing Barriers to the Adoption of Digital and Computational Pathology Technology by Clinical Labs
by Jeffrey L. Bessen, Melissa Alexander, Olivia Foroughi, Roderick Brathwaite, Emre Baser, Liam C. Lee, Omar Perez and Gary Gustavsen
Diagnostics 2025, 15(7), 794; https://doi.org/10.3390/diagnostics15070794 - 21 Mar 2025
Viewed by 1765
Abstract
Background/Objectives: Digital and computational pathology (DP/CP) tools have the potential to improve the efficiency and accuracy of the anatomic pathology workflow; however, current adoption among US hospital and reference labs remains low. Methods: To better understand the current utilization of DP/CP technology and [...] Read more.
Background/Objectives: Digital and computational pathology (DP/CP) tools have the potential to improve the efficiency and accuracy of the anatomic pathology workflow; however, current adoption among US hospital and reference labs remains low. Methods: To better understand the current utilization of DP/CP technology and barriers to widespread adoption, we conducted a survey among 63 anatomic pathologists and lab directors within the US health system. Results: The survey results indicated that current use cases for DP/CP involve streamlining traditional manual pathology and that labs would have substantial difficulty providing AI-guided image analysis if it were required by physicians today. Among potential catalysts for the broader adoption of DP/CP, pathologists identified clinical guidelines as a key resource for anatomic pathology, whose endorsement of DP/CP would be highly impactful for reducing current barriers. Conclusions: Expanded access to DP/CP may ultimately benefit all major stakeholders—patients, physicians, clinical laboratory professionals, care settings, and payers—and will therefore require collaboration across these groups. Full article
(This article belongs to the Special Issue Latest News in Digital Pathology)
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8 pages, 942 KiB  
Article
Improvements in Clinical Cancer Care Associated with Integration of Personalized Medicine
by Arushi Agarwal, Daryl Pritchard, Alissa Winzeler, Hina Mohammed, Thomas D. Brown and Gary G. Gustavsen
J. Pers. Med. 2024, 14(9), 997; https://doi.org/10.3390/jpm14090997 - 20 Sep 2024
Cited by 1 | Viewed by 2859
Abstract
Background: While adoption of personalized medicine (PM) continues to increase in clinical oncology, there is limited data connecting the level of PM adoption at a given institution to improved clinical outcomes for patients. The purpose of this study was to analyze the correlation [...] Read more.
Background: While adoption of personalized medicine (PM) continues to increase in clinical oncology, there is limited data connecting the level of PM adoption at a given institution to improved clinical outcomes for patients. The purpose of this study was to analyze the correlation between health care providers’ scores on a previously described PM integration framework and two outcome measures: the use of targeted therapy and clinical trial enrollment. Methods: This study was conducted using real-world data (RWD) from the Syapse® Learning Health Network (LHN). The PM integration score for six community hospital systems in the LHN was calculated and subsequently correlated with the two outcome measures. Results: Across six institutions, a strong correlation between PM integration score and targeted therapy use was observed in metastatic non-small cell lung cancer (mNSCLC) (R2 = 0.81), an indication with a significant number of approved targeted agents. Conversely, a strong correlation between PM integration score and clinical trial enrollment was observed in metastatic triple-negative breast cancer (TNBC) (R2 = 0.63), an indication with fewer marketed targeted therapies but an active targeted therapy pipeline. Conclusion: The results in these cases suggest that PM integration is a strong indicator of high-quality care practices for both utilization of targeted therapy in more mature PM indications (e.g., mNSCLC) and clinical trial enrollment in more emerging PM indications (e.g., TNBC). Full article
(This article belongs to the Section Molecular Targeted Therapy)
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14 pages, 2551 KiB  
Article
Perspectives on Clinical Adoption Barriers to Blood-Based Multi-Cancer Early Detection Tests across Stakeholders
by Monica M. Schroll, Elissa Quinn, Daryl Pritchard, Allina Chang, Kristen Garner Amanti, Omar Perez, Arushi Agarwal and Gary Gustavsen
J. Pers. Med. 2024, 14(6), 593; https://doi.org/10.3390/jpm14060593 - 1 Jun 2024
Cited by 3 | Viewed by 3450
Abstract
Current United States Preventive Services Task Force (USPSTF) recommendations include routine screening for breast, cervical, colorectal, and lung cancer; however, two out of every three cancer cases occur in other indications, leading to diagnoses in advanced stages of the disease and a higher [...] Read more.
Current United States Preventive Services Task Force (USPSTF) recommendations include routine screening for breast, cervical, colorectal, and lung cancer; however, two out of every three cancer cases occur in other indications, leading to diagnoses in advanced stages of the disease and a higher likelihood of mortality. Blood-based multi-cancer early detection (MCED) tests can impact cancer screening and early detection by monitoring for multiple different cancer types at once, including indications where screening is not performed routinely today. We conducted a survey amongst healthcare providers (HCPs), payers, and patients within the U.S. health system to understand the current utilization of cancer screening tests and the anticipated barriers to widespread adoption of blood-based MCED tests. The results indicated that the community favors the adoption of blood-based MCED tests and that there is broad agreement on the value proposition. Despite this recognition, the survey highlighted that there is limited use today due to the perceived lack of clinical accuracy and utility data, high out-of-pocket patient costs, and lack of payer coverage. To overcome the hurdles for future widespread adoption of blood-based MCED tests, increased investment in data generation, education, and implementation of logistical support for HCPs will be critical. Full article
(This article belongs to the Section Disease Biomarker)
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14 pages, 3637 KiB  
Article
Barriers to gBRCA Testing in High-Risk HER2-Negative Early Breast Cancer
by Olivia Foroughi, Shaheen Madraswala, Jennifer Hayes, Kara Glover, Liam Lee, Moumita Chaki, Stella Redpath, Agnes Weixuan Yu, David Chiu, Kristen Garner Amanti and Gary Gustavsen
J. Pers. Med. 2023, 13(8), 1228; https://doi.org/10.3390/jpm13081228 - 3 Aug 2023
Cited by 3 | Viewed by 4291
Abstract
Despite the OlympiA trial demonstrating that early-stage, high-risk, HER2- germline BRCA1 and BRCA2 mutation (gBRCAm) positive breast cancer patients can benefit from PARPi in the adjuvant setting, the gBRCA testing rate in early-stage HR+/HER2− patients remains suboptimal compared to that [...] Read more.
Despite the OlympiA trial demonstrating that early-stage, high-risk, HER2- germline BRCA1 and BRCA2 mutation (gBRCAm) positive breast cancer patients can benefit from PARPi in the adjuvant setting, the gBRCA testing rate in early-stage HR+/HER2− patients remains suboptimal compared to that in early-stage TNBC patients. To better understand the perceived barriers associated with gBRCA testing in HR+/HER2− disease, a quantitative survey was conducted across stakeholders (n = 430) including medical oncologists, surgeons, nurses, physician assistants, payers, and patients. This study revealed that while payers claim to cover gBRCA testing, poor clinician documentation and overutilization are key challenges. Therefore, payers place utilization management controls on gBRCA testing due to their impression that clinicians overtest. These controls have led to healthcare professionals experiencing payer pushback in the form of reimbursement limitations and denials. The perceived challenges to gBRCA testing stem from the lack of consensus dictating which patients are high risk and should be tested. While payers define high risk based on the CPS + EG score from the OlympiA trial, HCPs adopt a broader definition including genomic risk scores, lymph node involvement, and tumor grade and size. A dialogue to harmonize risk classification and testing eligibility across stakeholders is critical to address this disconnect and increase gBRCA testing in appropriate patients. Full article
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14 pages, 1061 KiB  
Article
Stakeholders Perceptions of Barriers to Precision Medicine Adoption in the United States
by Monica M. Schroll, Arushi Agarwal, Olivia Foroughi, Emily Kong, Omar Perez, Daryl Pritchard, Tom Breur, Kristen Garner Amanti and Gary Gustavsen
J. Pers. Med. 2022, 12(7), 1025; https://doi.org/10.3390/jpm12071025 - 22 Jun 2022
Cited by 8 | Viewed by 6439
Abstract
Despite evidence that precision medicine (PM) results in improved patient care, the broad adoption and implementation has been challenging across the United States (US). To better understand the perceived barriers associated with PM adoption, a quantitative survey was conducted across five stakeholders including [...] Read more.
Despite evidence that precision medicine (PM) results in improved patient care, the broad adoption and implementation has been challenging across the United States (US). To better understand the perceived barriers associated with PM adoption, a quantitative survey was conducted across five stakeholders including medical oncologists, surgeons, lab directors, payers, and patients. The results of the survey reveal that stakeholders are often not aligned on the perceived challenges with PM awareness, education and reimbursement, with there being stark contrast in viewpoints particularly between clinicians, payers, and patients. The output of this study aims to help raise the awareness that misalignment on the challenges to PM adoption is contributing to broader lack of implementation that ultimately impacts patients. With better understanding of stakeholder viewpoints, we can help alleviate the challenges by focusing on multi-disciplinary education and awareness to ultimately improve patient outcomes. Full article
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13 pages, 2548 KiB  
Article
A Quantitative Framework for Measuring Personalized Medicine Integration into US Healthcare Delivery Organizations
by Arushi Agarwal, Daryl Pritchard, Laura Gullett, Kristen Garner Amanti and Gary Gustavsen
J. Pers. Med. 2021, 11(3), 196; https://doi.org/10.3390/jpm11030196 - 12 Mar 2021
Cited by 12 | Viewed by 8144
Abstract
Personalized medicine (PM) approaches have revolutionized healthcare delivery by offering new insights that enable healthcare providers to select the optimal treatment approach for their patients. However, despite the consensus that these approaches have significant value, implementation across the US is highly variable. In [...] Read more.
Personalized medicine (PM) approaches have revolutionized healthcare delivery by offering new insights that enable healthcare providers to select the optimal treatment approach for their patients. However, despite the consensus that these approaches have significant value, implementation across the US is highly variable. In order to address barriers to widespread PM adoption, a comprehensive and methodical approach to assessing the current level of PM integration within a given organization and the broader healthcare system is needed. A quantitative framework encompassing a multifactorial approach to assessing PM adoption has been developed and used to generate a rating of PM integration in 153 organizations across the US. The results suggest significant heterogeneity in adoption levels but also some consistent themes in what defines a high-performing organization, including the sophistication of data collected, data sharing practices, and the level of internal funding committed to supporting PM initiatives. A longitudinal approach to data collection will be valuable to track continued progress and adapt to new challenges and barriers to PM adoption as they arise. Full article
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