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3. Longitudinal adherence to breast cancer surveillance following cancer genetic testing in an integrated health care system

Author

Knerr, Sarah, Guo, Boya, Wernli, Karen J., Mittendorf, Kathleen F., Feigelson, Heather Spencer, Gilmore, Marian J., Jarvik, Gail P., Kauffman, Tia L., Keast, Erin, Liles, Elizabeth G., Lynch, Frances L., Muessig, Kristin R., Okuyama, Sonia, Veenstra, David L., Zepp, Jamilyn M., Wilfond, Benjamin S., Devine, Beth, and Goddard, Katrina A. B.

Published
2023
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4. Conceptualization of utility in translational clinical genomics research

Author

Smith, Hadley Stevens, Brothers, Kyle B, Knight, Sara J, Ackerman, Sara L, Rini, Christine, Veenstra, David L, McGuire, Amy L, Wilfond, Benjamin S, and Malek, Janet

Subjects
Health Services and Systems, Health Sciences, Genetics, Human Genome, Generic health relevance, Good Health and Well Being, Concept Formation, Genomics, Humans, Translational Research, Biomedical, Biological Sciences, Medical and Health Sciences, Genetics & Heredity, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Prior to integration into clinical care, a novel medical innovation is typically assessed in terms of its balance of benefits and risks, often referred to as utility. Members of multidisciplinary research teams may conceptualize and assess utility in different ways, which has implications within the translational genomics community and for the evidence base upon which clinical guidelines groups and healthcare payers make decisions. Ambiguity in the conceptualization of utility in translational genomics research can lead to communication challenges within research teams and to study designs that do not meet stakeholder needs. We seek to address the ambiguity challenge by describing the conceptual understanding of utility and use of the term by scholars in the fields of philosophy, medicine, and the social sciences of decision psychology and health economics. We illustrate applications of each field's orientation to translational genomics research by using examples from the Clinical Sequencing Evidence-Generating Research (CSER) consortium, and we provide recommendations for increasing clarity and cohesion in future research. Given that different understandings of utility will align to a greater or lesser degree with important stakeholders' views, more precise use of the term can help researchers to better integrate multidisciplinary investigations and communicate with stakeholders.

Published
2021

5. Prospective, multi-site study of healthcare utilization after actionable monogenic findings from clinical sequencing

Author

Linder, Jodell E., Tao, Ran, Chung, Wendy K., Kiryluk, Krzysztof, Liu, Cong, Weng, Chunhua, Connolly, John J., Hakonarson, Hakon, Harr, Margaret, Leppig, Kathleen A., Jarvik, Gail P., Veenstra, David L., Aufox, Sharon, Chisholm, Rex L., Gordon, Adam S., Hoell, Christin, Rasmussen-Torvik, Laura J., Smith, Maureen E., Holm, Ingrid A., Miller, Erin M., Prows, Cynthia A., Elskeally, Omar, Kullo, Iftikhar J., Lee, Christopher, Jose, Sheethal, Manolio, Teri A., Rowley, Robb, Padi-Adjirackor, Nana Addo, Wilmayani, Ni Ketut, City, Brittany, Wei, Wei-Qi, Wiesner, Georgia L., Rahm, Alanna Kulchak, Williams, Janet L., Williams, Marc S., and Peterson, Josh F.

Published
2023
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6. Most people share genetic test results with relatives even if the findings are normal: Family communication in a diverse population

Author

Allen, Jake, Angelo, Frank, Arnold, Briana L., Bellcross, Cecelia, Bendelow, Tiffany, B, Barbara, Biesecker, Breslin, Kristin D., Booker, Kristina F., Caruncho, Mikaella, Davis, James V., Deutsch, Sonia, Devine, Beth, Dorschner, Michael O., Duenas, Devan, Eubanks, Donna J., Feigelson, Heather Spencer, Freed, Amanda S., Greaney, Clay, Gruß, Inga, Guerra, Claudia, Guo, Boya, Holup, Joan, Ingphakorn, Chalinya L., Jackson, Paige, Jarvik, Gail P., Jenkins, Charisma L., Karliner, Leah S., Kaufmann, Tia, Keast, Erin, Knerr, Sarah, Koomas, Alyssa H., Kraft, Stephanie A., Lee, Mi H., Lee, Robin, Soo-Jin Lee, Sandra, Lewis, Hannah S., Liles, Elizabeth G., Lindberg, Nangel M., Lynch, Frances, McMullen, Carmit K., Medina, Elizabeth, Mittendorf, Kathleen F., Muessig, Kristin R., Okuyama, Sonia, Peterson, C. Samuel, Paolucci, Angela R., Perez, Rosse Rodriguez, Porter, Kathryn M., Ransom, Chelese L., Reyes, Ana, Robinson, Sperry, Rolf, Bradley A., Rope, Alan F., Schield, Emily, Schneider, Jennifer L., Shipman, Kelly J., Shirts, Brian H., Shuster, Elizabeth, Syngal, Sapna, Torgrimson-Ojerio, Britta N., Ukaegbu, Chinedu, Vandermeer, Meredith L., Varga, Alexandra M., Veenstra, David L., Whitebirch, W. Chris, Lee White, Larissa, Hunter, Jessica Ezzell, Riddle, Leslie, Joseph, Galen, Amendola, Laura M., Gilmore, Marian J., Zepp, Jamilyn M., Bulkley, Joanna E., Anderson, Katherine P., Goddard, Katrina A.B., Wilfond, Benjamin S., and Leo, Michael C.

Published
2023
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11. Laboratory-related outcomes from integrating an accessible delivery model for hereditary cancer risk assessment and genetic testing in populations with barriers to access

Author

Allen, Jake, Amendola, Laura M., Anderson, Katherine P., Angelo, Frank, Arnold, Briana L., Bellcross, Cecelia, Bendelow, Tiffany, Biesecker, Barbara B., Breslin, Kristin D., Bulkley, Joanna E., Booker, Kristina F., Caruncho, Mikaella, Davis, James V., Deutsch, Sonia, Devine, Beth, Dorschner, Michael O., Duenas, Devan M., Eubanks, Donna J., Feigelson, Heather Spencer, Freed, Amanda S., Gilmore, Marian J., Goddard, Katrina A.B., Greaney, Clay, Gruß, Inga, Guerra, Claudia, Guo, Boya, Holup, Joan, Hunter, Jessica Ezzell, Ingphakorn, Chalinya L., Jackson, Paige, Jarvik, Gail P., Jenkins, Charisma L., Joseph, Galen, Karliner, Leah S., Kauffman, Tia L., Keast, Erin, Knerr, Sarah, Koomas, Alyssa H., Kraft, Stephanie A., Lee, Mi H., Lee, Robin, Soo-Jin Lee, Sandra, Leo, Michael C., Lewis, Hannah S., Liles, Elizabeth G., Lindberg, Nangel M., Lynch, Frances, McMullen, Carmit K., Medina, Elizabeth, Mittendorf, Kathleen F., Muessig, Kristin R., Okuyama, Sonia, Peterson, C. Samuel, Paolucci, Angela R., Perez, Rosse Rodriguez, Porter, Kathryn M., Ransom, Chelese L., Reyes, Ana, Riddle, Leslie S., Robinson, Sperry, Rolf, Bradley A., Rope, Alan F., Schield, Emily, Schneider, Jennifer L., Shipman, Kelly J., Shirts, Brian H., Shuster, Elizabeth, Syngal, Sapna, Torgrimson-Ojerio, Britta N., Ukaegbu, Chinedu, Vandermeer, Meredith L., Varga, Alexandra M., Veenstra, David L., Whitebirch, W. Chris, Lee White, Larissa, Wilfond, Benjamin S., Zepp, Jamilyn M., Bellcross, Cecilia, and Riddle, Leslie

Published
2022
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16. Cost-Effectiveness Analysis of Patiromer and Spironolactone Therapy in Heart Failure Patients with Hyperkalemia

Author

Bounthavong, Mark, Butler, Javed, Dolan, Chantal M, Dunn, Jeffrey D, Fisher, Kathryn A, Oestreicher, Nina, Pitt, Bertram, Hauptman, Paul J, and Veenstra, David L

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Cardiovascular, Comparative Effectiveness Research, Clinical Research, Cost Effectiveness Research, Heart Disease, Health Services, Good Health and Well Being, Aged, Cost-Benefit Analysis, Diuretics, Economics, Pharmaceutical, Heart Failure, Hospitalization, Humans, Hyperkalemia, Markov Chains, Polymers, Quality-Adjusted Life Years, Randomized Controlled Trials as Topic, Spironolactone, Treatment Outcome, Medical and Health Sciences, Economics, Health Policy & Services, Pharmacology and pharmaceutical sciences, Applied economics, Health services and systems
Abstract

Background and objectiveCertain patients with heart failure (HF) are unable to tolerate spironolactone therapy due to hyperkalemia. Patiromer is a novel agent used to treat hyperkalemia and has been shown to be efficacious, safe, and well-tolerated. The potential clinical outcomes and economic value of using patiromer and spironolactone in patients with HF unable to otherwise tolerate spironolactone due to hyperkalemia are unclear. The objective of this analysis was to model the potential pharmacoeconomic value of using patiromer and spironolactone in patients with a history of hyperkalemia that prevents them from utilizing spironolactone.MethodsWe performed a cost-effectiveness analysis of treatment with patiromer, spironolactone, and an angiotensin-converting enzyme inhibitor (ACEI) in patients with New York Heart Association (NYHA) class III-IV HF compared with ACEI alone. A Markov model was constructed to simulate a cohort of 65-year-old patients diagnosed with HF from the payer perspective across the lifetime horizon. Clinical inputs were derived from the RALES and OPAL-HK randomized trials of spironolactone and patiromer, respectively. Utility estimates and costs were derived from the literature and list prices. Outcomes assessed included hospitalization, life expectancy, and quality-adjusted life-years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER). One-way and probability sensitivity analyses were performed to test the robustness of the model findings.ResultsTreatment with patiromer-spironolactone-ACEI was projected to increase longevity compared with ACEI alone (5.29 vs. 4.62 life-years gained, respectively), greater QALYs (2.79 vs. 2.60), and costs (US$28,200 vs. US$18,200), giving an ICER of US$52,700 per QALY gained. The ICERs ranged from US$40,000 to US$85,800 per QALY gained in 1-way sensitivity analyses.ConclusionOur results suggest that the use of spironolactone-patiromer-ACEI may provide clinical benefit and good economic value in patients with NYHA class III-IV HF unable to tolerate spironolactone due to hyperkalemia.

Published
2018

17. The Clinical Sequencing Evidence-Generating Research Consortium: Integrating Genomic Sequencing in Diverse and Medically Underserved Populations

Author

Amendola, Laura M, Berg, Jonathan S, Horowitz, Carol R, Angelo, Frank, Bensen, Jeannette T, Biesecker, Barbara B, Biesecker, Leslie G, Cooper, Gregory M, East, Kelly, Filipski, Kelly, Fullerton, Stephanie M, Gelb, Bruce D, Goddard, Katrina AB, Hailu, Benyam, Hart, Ragan, Hassmiller-Lich, Kristen, Joseph, Galen, Kenny, Eimear E, Koenig, Barbara A, Knight, Sara, Kwok, Pui-Yan, Lewis, Katie L, McGuire, Amy L, Norton, Mary E, Ou, Jeffrey, Parsons, Donald W, Powell, Bradford C, Risch, Neil, Robinson, Mimsie, Rini, Christine, Scollon, Sarah, Slavotinek, Anne M, Veenstra, David L, Wasserstein, Melissa P, Wilfond, Benjamin S, Hindorff, Lucia A, consortium, CSER, Plon, Sharon E, and Jarvik, Gail P

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Genetics, Health Services and Systems, Health Sciences, Clinical Sciences, Human Genome, Precision Medicine, Health Services, Biotechnology, Clinical Trials and Supportive Activities, Clinical Research, Generic health relevance, Good Health and Well Being, Adult, Cost-Benefit Analysis, Delivery of Health Care, Europe, Exome, Genome, Human, Genomics, Humans, National Human Genome Research Institute (U.S.), Phenotype, United States, Whole Genome Sequencing, CSER consortium, Medical and Health Sciences, Genetics & Heredity, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

The Clinical Sequencing Evidence-Generating Research (CSER) consortium, now in its second funding cycle, is investigating the effectiveness of integrating genomic (exome or genome) sequencing into the clinical care of diverse and medically underserved individuals in a variety of healthcare settings and disease states. The consortium comprises a coordinating center, six funded extramural clinical projects, and an ongoing National Human Genome Research Institute (NHGRI) intramural project. Collectively, these projects aim to enroll and sequence over 6,100 participants in four years. At least 60% of participants will be of non-European ancestry or from underserved settings, with the goal of diversifying the populations that are providing an evidence base for genomic medicine. Five of the six clinical projects are enrolling pediatric patients with various phenotypes. One of these five projects is also enrolling couples whose fetus has a structural anomaly, and the sixth project is enrolling adults at risk for hereditary cancer. The ongoing NHGRI intramural project has enrolled primarily healthy adults. Goals of the consortium include assessing the clinical utility of genomic sequencing, exploring medical follow up and cascade testing of relatives, and evaluating patient-provider-laboratory level interactions that influence the use of this technology. The findings from the CSER consortium will offer patients, healthcare systems, and policymakers a clearer understanding of the opportunities and challenges of providing genomic medicine in diverse populations and settings, and contribute evidence toward developing best practices for the delivery of clinically useful and cost-effective genomic sequencing in diverse healthcare settings.

Published
2018

24. Clinical exome sequencing vs. usual care for hereditary colorectal cancer diagnosis: A pilot comparative effectiveness study

Author

Niu, Xin, Amendola, Laura M., Hart, Ragan, Bennette, Caroline S., Heagerty, Patrick, Horike-Pyne, Martha, Trinidad, Susan B., Rosenthal, Elisabeth A., Comstock, Bryan, Nefcy, Chris, Hisama, Fuki M., Bennett, Robin L., Grady, William M., Gallego, Carlos J., Tarczy-Hornoch, Peter, Fullerton, Stephanie M., Burke, Wylie, Regier, Dean A., Dorschner, Michael O., Shirts, Brian H., Robertson, Peggy D., Nickerson, Deborah A., Patrick, Donald L., Jarvik, Gail P., and Veenstra, David L.

Published
2019
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26. Secondary findings from clinical genomic sequencing: prevalence, patient perspectives, family history assessment, and health-care costs from a multisite study

Author

Hart, M. Ragan, Biesecker, Barbara B., Blout, Carrie L., Christensen, Kurt D., Amendola, Laura M., Bergstrom, Katie L., Biswas, Sawona, Bowling, Kevin M., Brothers, Kyle B., Conlin, Laura K., Cooper, Greg M., Dulik, Matthew C., East, Kelly M., Everett, Jessica N., Finnila, Candice R., Ghazani, Arezou A., Gilmore, Marian J., Goddard, Katrina A. B, Jarvik, Gail P., Johnston, Jennifer J., Kauffman, Tia L., Kelley, Whitley V., Krier, Joel B., Lewis, Katie L., McGuire, Amy L., McMullen, Carmit, Ou, Jeffrey, Plon, Sharon E., Rehm, Heidi L., Richards, C. Sue, Romasko, Edward J., Miren Sagardia, Ane, Spinner, Nancy B., Thompson, Michelle L., Turbitt, Erin, Vassy, Jason L., Wilfond, Benjamin S., Veenstra, David L., Berg, Jonathan S., Green, Robert C., Biesecker, Leslie G., and Hindorff, Lucia A.

Published
2019
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27. The EGAPP initiative: lessons learned

Author

Calonge, Ned, Klein, Roger D, Berg, Alfred O, Berg, Jonathan S, Armstrong, Katrina, Botkin, Jeffrey, Campos-Outcalt, Doug, Djulbegovic, Benjamin, Fisher, Nancy L, Ganiats, Theodore G, Haddow, James E, Hayes, Maxine, Janssens, A Cecile JW, Kaye, Celia, Lyman, Donald O, Offit, Kenneth, Pauker, Stephen G, Phillips, Kathryn A, Piper, Margaret, Richards, Carolyn Sue, Scott, Joan A, Strickland, Ora L, Teutsch, Steven, Tunis, Sean R, Veenstra, David L, Williams, Marc S, and Zallen, Doris T

Subjects
Human Genome, Genetics, Prevention, Good Health and Well Being, Evidence-Based Medicine, Genetic Testing, Genome-Wide Association Study, Genomics, Humans, Public Health, Translational Research, Biomedical, evidence-based medicine, genetics, guideline development, public health genomics, systematic review methods, Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group, Clinical Sciences, Genetics & Heredity
Abstract

The Evaluation of Genomic Applications in Practice and Prevention Working Group was first convened in 2005 to develop and test evidence-based methods for the evaluation of genomic tests in transition from research to clinical and public health practice. Over the ensuing years, the Working Group has met 26 times, publishing eight recommendation statements, two methods papers, and one outcomes paper, as well as planning and serving as technical experts on numerous associated systematic reviews. Evaluation of Genomic Applications in Practice and Prevention methods have evolved to address implications of the proliferation of genome-wide association studies and are currently expanding to face challenges expected from clinical implementation of whole-genome sequencing tests. In this article, we review the work of the Evaluation of Genomic Applications in Practice and Prevention Working Group over the first 8 years of its existence with an emphasis on lessons learned throughout the process. It is hoped that in addition to the published methods of the Working Group, the lessons we have learned along the way will be informative to others who are producers and consumers of evidence-based guidelines in the field of genomic medicine.

Published
2014

28. Budget impact of oral nirmatrelvir/ritonavir in adults at high risk for progression to severe COVID-19 in the United States

Author

Sandin, Rickard, primary, Veenstra, David L., additional, Vankelegom, Mathilde, additional, Dzingina, Mendwas, additional, Sullivan, Sean D., additional, Campbell, David, additional, Ma, Cuiying, additional, Harrison, Cale, additional, Draica, Florin, additional, Wiemken, Timothy Lee, additional, and Mugwagwa, Tendai, additional

Published
2023
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35. Harmonizing Outcomes for Genomic Medicine: Comparison of eMERGE Outcomes to ClinGen Outcome/Intervention Pairs

Author

Williams, Janet L., primary, Chung, Wendy K., additional, Fedotov, Alex, additional, Kiryluk, Krzysztof, additional, Weng, Chunhua, additional, Connolly, John J., additional, Harr, Margaret, additional, Hakonarson, Hakon, additional, Leppig, Kathleen A., additional, Larson, Eric B., additional, Jarvik, Gail P., additional, Veenstra, David L., additional, Hoell, Christin, additional, Smith, Maureen E., additional, Holm, Ingrid A., additional, Peterson, Josh F., additional, and Williams, Marc S., additional

Published
2020
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36. Implementation evaluation of academic detailing on naloxone prescribing trends at the United States Veterans Health Administration

Author

Bounthavong, Mark, Devine, Emily Beth, Christopher, Melissa L.D., Harvey, Michael A., Veenstra, David L., and Basu, Anirban

Subjects
United States. Department of Veterans Affairs -- Analysis, Mortality -- Analysis, Opioid abuse -- Analysis, Naloxone -- Analysis, Prescription writing -- Analysis, Overdose -- Analysis, Drugstores -- Analysis, Education, Business, Health care industry
Abstract

Objective: Academic detailing in partnership with the Opioid Overdose Education and Naloxone Distribution (OEND) program was implemented to increase naloxone access for the prevention of opioid overdose mortality in veterans at the U.S. Department of Veterans Affairs (VA). However, implementation was not uniform leading to varying levels of intervention exposure potentially impacting naloxone prescribing. We examined the impact of implementation strength (proportion of providers exposed to academic detailing) at each station on naloxone prescribing from September 2014 to December 2017. Study Design and Setting: Retrospective cohort design with fixed effects models at the VA. Data Collection/Extraction Methods: We used VA Corporate Data Warehouse for data on pharmacy dispensing, station-, provider- and patient-level characteristics. OEND-specific academic detailing activities came from data recorded by academic detailers using Salesforce.com. Principal Findings: VA stations wherein 100 percent of providers exposed to an OEND-related academic detailing educational outreach visit experienced an increased incident rate of naloxone prescribing that was 5.52 times the incident rate of stations where no providers were exposed; alternatively, this is equivalent to an average monthly increase of 2.60 naloxone prescriptions per 1000 population at risk for opioid overdose. Conclusions: Our findings highlight the importance of academic detailing's implementation strength on naloxone prescribing. Decision makers must carefully consider the implementation process to achieve the greatest effectiveness from the intervention. KEYWORDS academic detailing, educational outreach, implementation, naloxone, opioid overdose, veterans, 1 | BACKGROUND Opioid overdose mortality has become a national epidemic and public health policy concern in the United States (U.S.). There were over 47 000 opioid overdose deaths in [...]

Published
2019
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39. Population Genomic Screening for Three Common Hereditary Conditions

Author

Guzauskas, Gregory F., primary, Garbett, Shawn, additional, Zhou, Zilu, additional, Schildcrout, Jonathan S., additional, Graves, John A., additional, Williams, Marc S., additional, Hao, Jing, additional, Jones, Laney K., additional, Spencer, Scott J., additional, Jiang, Shangqing, additional, Veenstra, David L., additional, and Peterson, Josh F., additional

Published
2023
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40. Practical considerations for reinterpretation of individual genetic variants

Author

Appelbaum, Paul S., primary, Berger, Sara M., additional, Brokamp, Elly, additional, Brown, Henry Shelton, additional, Burke, Wylie, additional, Clayton, Ellen Wright, additional, Evans, Barbara J., additional, Hamid, Rizwan, additional, Marchant, Gary E., additional, Martin, Donna M., additional, O’Connor, Bridget C., additional, Pagán, José A., additional, Parens, Erik, additional, Roberts, Jessica L., additional, Rowe, John, additional, Schneider, John, additional, Siegel, Karolynn, additional, Veenstra, David L., additional, and Chung, Wendy K., additional

Published
2023
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41. Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine

Author

Amaral, Michelle, Amendola, Laura, Appelbaum, Paul S., Aronson, Samuel J., Arora, Shubhangi, Azzariti, Danielle R., Barsh, Greg S., Bebin, E.M., Biesecker, Barbara B., Biesecker, Leslie G., Biswas, Sawona, Blout, Carrie L., Bowling, Kevin M., Brothers, Kyle B., Brown, Brian L., Burt, Amber A., Byers, Peter H., Caga-anan, Charlisse F., Calikoglu, Muge G., Carlson, Sara J., Chahin, Nizar, Chinnaiyan, Arul M., Christensen, Kurt D., Chung, Wendy, Cirino, Allison L., Clayton, Ellen, Conlin, Laura K., Cooper, Greg M., Crosslin, David R., Davis, James V., Davis, Kelly, Deardorff, Matthew A., Devkota, Batsal, De Vries, Raymond, Diamond, Pamela, Dorschner, Michael O., Dugan, Noreen P., Dukhovny, Dmitry, Dulik, Matthew C., East, Kelly M., Rivera-Munoz, Edgar A., Evans, Barbara, Evans, James P., Everett, Jessica, Exe, Nicole, Fan, Zheng, Feuerman, Lindsay Z., Filipski, Kelly, Finnila, Candice R., Fishler, Kristen, Fullerton, Stephanie M., Ghrundmeier, Bob, Giles, Karen, Gilmore, Marian J., Girnary, Zahra S., Goddard, Katrina, Gonsalves, Steven, Gordon, Adam S., Gornick, Michele C., Grady, William M., Gray, David E., Gray, Stacy W., Green, Robert, Greenwood, Robert S., Gutierrez, Amanda M., Han, Paul, Hart, Ragan, Heagerty, Patrick, Henderson, Gail E., Hensman, Naomi, Hiatt, Susan M., Himes, Patricia, Hindorff, Lucia A., Hisama, Fuki M., Ho, Carolyn Y., Hoffman-Andrews, Lily B., Holm, Ingrid A., Hong, Celine, Horike-Pyne, Martha J., Hull, Sara, Hutter, Carolyn M., Jamal, Seema, Jarvik, Gail P., Jensen, Brian C., Joffe, Steve, Johnston, Jennifer, Karavite, Dean, Kauffman, Tia L., Kaufman, Dave, Kelley, Whitley, Kim, Jerry H., Kirby, Christine, Klein, William, Knoppers, Bartha, Koenig, Barbara A., Kong, Sek Won, Krantz, Ian, Krier, Joel B., Lamb, Neil E., Lambert, Michele P., Le, Lan Q., Lebo, Matthew S., Lee, Alexander, Lee, Kaitlyn B., Lennon, Niall, Leo, Michael C., Leppig, Kathleen A., Lewis, Katie, Lewis, Michelle, Lindeman, Neal I., Lockhart, Nicole, Lonigro, Bob, Lose, Edward J., Lupo, Philip J., Rodriguez, Laura Lyman, Lynch, Frances, Machini, Kalotina, MacRae, Calum, Manolio, Teri A., Marchuk, Daniel S., Martinez, Josue N., Masino, Aaron, McCullough, Laurence, McEwen, Jean, McGuire, Amy, McLaughlin, Heather M., McMullen, Carmit, Mieczkowski, Piotr A., Miller, Jeff, Miller, Victoria A., Mody, Rajen, Mooney, Sean D., Moore, Elizabeth G., Morris, Elissa, Murray, Michael, Muzny, Donna, Myers, Richard M., Ng, David, Nickerson, Deborah A., Oliver, Nelly M., Ou, Jeffrey, Parsons, Will, Patrick, Donald L., Pennington, Jeffrey, Perry, Denise L., Petersen, Gloria, Plon, Sharon, Porter, Katie, Powell, Bradford C., Punj, Sumit, Breitkopf, Carmen Radecki, Raesz-Martinez, Robin A., Raskind, Wendy H., Rehm, Heidi L., Reigar, Dean A., Reiss, Jacob A., Rich, Carla A., Richards, Carolyn Sue, Rini, Christine, Roberts, Scott, Robertson, Peggy D., Robinson, Dan, Robinson, Jill O., Robinson, Marguerite E., Roche, Myra I., Romasko, Edward J., Rosenthal, Elisabeth A., Salama, Joseph, Scarano, Maria I., Schneider, Jennifer, Scollon, Sarah, Seidman, Christine E., Seifert, Bryce A., Sharp, Richard R., Shirts, Brian H., Sholl, Lynette M., Siddiqui, Javed, Silverman, Elian, Simmons, Shirley, Simons, Janae V., Skinner, Debra, Spinner, Nancy B., Stoffel, Elena, Strande, Natasha T., Sunyaev, Shamil, Sybert, Virginia P., Taber, Jennifer, Tabor, Holly K., Tarczy-Hornoch, Peter, Taylor, Deanne M., Tilley, Christian R., Tomlinson, Ashley, Trinidad, Susan, Tsai, Ellen, Ubel, Peter, Van Allen, Eliezer M., Vassy, Jason L., Vats, Pankaj, Veenstra, David L., Vetter, Victoria L., Vries, Raymond D., Wagle, Nikhil, Walser, Sarah A., Walsh, Rebecca C., Weck, Karen, Werner-Lin, Allison, Whittle, Jana, Wilfond, Ben, Wilhelmsen, Kirk C., Wolf, Susan M., Wynn, Julia, Yang, Yaping, Young, Carol, Yu, Joon-Ho, Zikmund-Fisher, Brian J., Green, Robert C., Goddard, Katrina A.B., Amendola, Laura M., Berg, Jonathan S., Bernhardt, Barbara A., Burke, Wylie, Chung, Wendy K., Clayton, Ellen W., Cooper, Gregory M., East, Kelly, Garraway, Levi A., Garrett, Jeremy R., Lewis, Michelle Huckaby, Janne, Pasi A., Joffe, Steven, Kaufman, David, Knoppers, Bartha M., Krantz, Ian D., Parsons, Donald W., Petersen, Gloria M., Plon, Sharon E., Roberts, J. Scott, Salama, Joseph S., Shirts, Brian, Wilfond, Benjamin S., and Wilhelmsen, Kirk

Published
2016
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45. Comparative effectiveness of next generation genomic sequencing for disease diagnosis: Design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes

Author

Gallego, Carlos J., Bennette, Caroline S., Heagerty, Patrick, Comstock, Bryan, Horike-Pyne, Martha, Hisama, Fuki, Amendola, Laura M., Bennett, Robin L., Dorschner, Michael O., Tarczy-Hornoch, Peter, Grady, William M., Fullerton, S. Malia, Trinidad, Susan B., Regier, Dean A., Nickerson, Deborah A., Burke, Wylie, Patrick, Donald L., Jarvik, Gail P., and Veenstra, David L.

Published
2014
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47. Correction: Secondary findings from clinical genomic sequencing: prevalence, patient perspectives, family history assessment, and health-care costs from a multisite study

Author

Hart, M. Ragan, Biesecker, Barbara B., Blout, Carrie L., Christensen, Kurt D., Amendola, Laura M., Bergstrom, Katie L., Biswas, Sawona, Bowling, Kevin M., Brothers, Kyle B., Conlin, Laura K., Cooper, Greg M., Dulik, Matthew C., East, Kelly M., Everett, Jessica N., Finnila, Candice R., Ghazani, Arezou A., Gilmore, Marian J., Goddard, Katrina A. B., Jarvik, Gail P., Johnston, Jennifer J., Kauffman, Tia L., Kelley, Whitley V., Krier, Joel B., Lewis, Katie L., McGuire, Amy L., McMullen, Carmit, Ou, Jeffrey, Plon, Sharon E., Rehm, Heidi L., Richards, C. Sue, Romasko, Edward J., Sagardia, Ane Miren, Spinner, Nancy B., Thompson, Michelle L., Turbitt, Erin, Vassy, Jason L., Wilfond, Benjamin S., Veenstra, David L., Berg, Jonathan S., Green, Robert C., Biesecker, Leslie G., and Hindorff, Lucia A.

Published
2019
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48. Risk management actions following genetic testing in the Cancer Health Assessments Reaching Many (CHARM) Study: A prospective cohort study.

Author

Guo, Boya, Knerr, Sarah, Kauffman, Tia L., Mittendorf, Kathleen F., Keast, Erin, Gilmore, Marian J., Feigelson, Heather Spencer, Lynch, Frances L., Muessig, Kristin R., Okuyama, Sonia, Zepp, Jamilyn M., Veenstra, David L., Hsu, Li, Phipps, Amanda I., Lindström, Sara, Leo, Michael C., Goddard, Katrina A. B., Wilfond, Benjamin S., Devine, Beth, and Allen, Jake

Subjects
GENETIC testing, MAGNETIC resonance mammography, COHORT analysis, LONGITUDINAL method, MEDICAL screening, ELECTRONIC health records
Abstract

Background: Genetic testing can identify cancer risk early, enabling prevention and early detection. We describe use of risk management interventions following genetic testing in the Cancer Health Assessment Reaching Many (CHARM) study. CHARM assessed risk and provided genetic testing to low income, low literacy, and other underserved populations that historically face barriers to accessing cancer genetic services. Methods: CHARM was implemented in Kaiser Permanente Northwest (KPNW) and Denver Health (DH) between 2018 and 2020. We identified post‐testing screening (mammography, breast MRI, colonoscopy) and surgical (mastectomy, oophorectomy) procedures using electronic health records. We examined utilization in participants who did and did not receive actionable risk management recommendations from study genetic counselors following national guidelines. Results: CHARM participants were followed for an average of 15.4 months (range: 0.4–27.8 months) after results disclosure. Less than 2% (11/680) received actionable risk management recommendations (i.e., could be completed in the initial years following testing) based on their test result. Among those who received actionable recommendations, risk management utilization was moderate (54.5%, 6/11 completed any procedure) and varied by procedure (mammogram: 0/3; MRI: 2/4; colonoscopy: 4/5; mastectomy: 1/5; oophorectomy: 0/3). Cancer screening and surgery procedures were rare in participants without actionable recommendations. Conclusion: Though the number of participants who received actionable risk management recommendations was small, our results suggest that implementing CHARM's risk assessment and testing model increased access to evidence‐based genetic services and provided opportunities for patients to engage in recommended preventive care, without encouraging risk management overuse. [ABSTRACT FROM AUTHOR]

Published
2023
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50. Cost-effectiveness frameworks for comparing genome and exome sequencing versus conventional diagnostic pathways: A scoping review and recommended methods

Author

Ferket, Bart S., primary, Baldwin, Zach, additional, Murali, Priyanka, additional, Pai, Akila, additional, Mittendorf, Kathleen F., additional, Russell, Heidi V., additional, Chen, Flavia, additional, Lynch, Frances L., additional, Lich, Kristen Hassmiller, additional, Hindorff, Lucia A., additional, Savich, Renate, additional, Slavotinek, Anne, additional, Smith, Hadley Stevens, additional, Gelb, Bruce D., additional, and Veenstra, David L., additional

Published
2022
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