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2. The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship

Author

Henrikson, Nora B, Anderson, Melissa L, Dickerson, John, Ewing, John J, Garcia, Robin, Keast, Erin, King, Deborah A, Lewis, Cara, Locher, Blake, McMullen, Carmit, Norris, Consuelo M, Petrik, Amanda F, Ramaprasan, Arvind, Rivelli, Jennifer S, Schneider, Jennifer L, Shulman, Lisa, Tuzzio, Leah, and Banegas, Matthew P

Subjects
Health Services and Systems, Nursing, Health Sciences, Clinical Trials and Supportive Activities, Behavioral and Social Science, Health Services, Prevention, Clinical Research, Cancer, Prevention of disease and conditions, and promotion of well-being, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Good Health and Well Being, Adolescent, Financial Stress, Humans, Neoplasms, Quality of Life, Treatment Outcome, Financial hardship, Supportive care, Patient navigation, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine, Clinical sciences, Epidemiology, Health services and systems
Abstract

BackgroundThere is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention.MethodsThe Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received.DiscussionThe CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial's strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective.Trial registrationClinicalTrials.gov NCT05018000 . August 23, 2021.

Published
2022

4. Integration of stakeholder engagement from development to dissemination in genomic medicine research: Approaches and outcomes from the CSER Consortium

Author

O’Daniel, Julianne M, Ackerman, Sara, Desrosiers, Lauren R, Rego, Shannon, Knight, Sara J, Mollison, Lonna, Byfield, Grace, Anderson, Katherine P, Danila, Maria I, Horowitz, Carol R, Joseph, Galen, Lamoure, Grace, Lindberg, Nangel M, McMullen, Carmit K, Mittendorf, Kathleen F, Ramos, Michelle A, Robinson, Mimsie, Sillari, Catherine, Madden, Ebony B, and Group, CSER Stakeholder and Engagement Work

Subjects
Biological Sciences, Genetics, Human Genome, Health Disparities, Minority Health, Generic health relevance, Good Health and Well Being, Genomic Medicine, Genomics, Humans, Population Groups, Research Design, Stakeholder Participation, Clinical research, Genetic medicine, Stakeholders, Stakeholder engagement, CSER Stakeholder and Engagement Work Group, Clinical Sciences, Genetics & Heredity
Abstract

PurposeThere is a critical need for genomic medicine research that reflects and benefits socioeconomically and ancestrally diverse populations. However, disparities in research populations persist, highlighting that traditional study designs and materials may be insufficient or inaccessible to all groups. New approaches can be gained through collaborations with patient/community stakeholders. Although some benefits of stakeholder engagement are recognized, routine incorporation into the design and implementation of genomics research has yet to be realized.MethodsThe National Institutes of Health-funded Clinical Sequencing Evidence-Generating Research (CSER) consortium required stakeholder engagement as a dedicated project component. Each CSER project planned and carried out stakeholder engagement activities with differing goals and expected outcomes. Examples were curated from each project to highlight engagement strategies and outcomes throughout the research lifecycle from development through dissemination.ResultsProjects tailored strategies to individual study needs, logistical constraints, and other challenges. Lessons learned include starting early with engagement efforts across project stakeholder groups and planned flexibility to enable adaptations throughout the project lifecycle.ConclusionEach CSER project used more than 1 approach to engage with relevant stakeholders, resulting in numerous adaptations and tremendous value added throughout the full research lifecycle. Incorporation of community stakeholder insight improves the outcomes and relevance of genomic medicine research.

Published
2022

5. Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial

Author

Mayhew, Meghan, Balderson, Benjamin H., Cook, Andrea J., Dickerson, John F., Elder, Charles R., Firemark, Alison J., Haller, Irina V., Justice, Morgan, Keefe, Francis J., McMullen, Carmit K., O’Keeffe-Rosetti, Maureen C., Owen-Smith, Ashli A., Rini, Christine, Schneider, Jennifer L., Von Korff, Michael, Wandner, Laura D., and DeBar, Lynn L.

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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7. Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol’s evolution

Author

Kraft, Stephanie A, McMullen, Carmit, Lindberg, Nangel M, Bui, David, Shipman, Kelly, Anderson, Katherine, Joseph, Galen, Duenas, Devan M, Porter, Kathryn M, Kauffman, Tia L, Koomas, Alyssa, Ransom, Chelese L, Jackson, Paige, Goddard, Katrina AB, Wilfond, Benjamin S, and Lee, Sandra Soo-Jin

Subjects
Human Genome, Biotechnology, Clinical Research, Genetics, Patient Safety, Health and social care services research, 8.1 Organisation and delivery of services, Generic health relevance, Good Health and Well Being, Ethics Committees, Research, Feedback, Genomics, Humans, Informed Consent, Research Personnel, stakeholder engagement, informed consent, recruitment, institutional review board, ethics, Clinical Sciences, Genetics & Heredity
Abstract

PurposeThis study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations.MethodsWe conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials.ResultsOur analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations.ConclusionsWhile involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

Published
2020

9. ORCA, a values-based decision aid for selecting additional findings from genomic sequencing in adults: Efficacy results from a randomized trial

Author

Liles, Elizabeth G., Leo, Michael C., Freed, Amanda S., Porter, Kathryn M., Zepp, Jamilyn M., Kauffman, Tia L., Keast, Erin, McMullen, Carmit K., Gruß, Inga, Biesecker, Barbara B., Muessig, Kristin R., Eubanks, Donna J., Amendola, Laura M., Dorschner, Michael O., Rolf, Bradley A., Jarvik, Gail P., Goddard, Katrina A.B., and Wilfond, Benjamin S.

Published
2022
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10. 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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11. Adaptation and early implementation of the PREdiction model for gene mutations (PREMM5™) for lynch syndrome risk assessment in a diverse population

Author

Mittendorf, Kathleen F., Ukaegbu, Chinedu, Gilmore, Marian J., Lindberg, Nangel M., Kauffman, Tia L., Eubanks, Donna J., Shuster, Elizabeth, Allen, Jake, McMullen, Carmit, Feigelson, Heather Spencer, Anderson, Katherine P., Leo, Michael C., Hunter, Jessica Ezzell, Sasaki, Sonia Okuyama, Zepp, Jamilyn M., Syngal, Sapna, Wilfond, Benjamin S., and Goddard, Katrina A. B.

Published
2022
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15. Virtual care is a double-edged sword : Adjusting preventive care service delivery in community health clinics during COVID-19.

Author

Papajorgji-Taylor, Dea, Sheppler, Christina R., McMullen, Carmit, O'Connor, Patrick J., and Gold, Rachel

Subjects
COVID-19 pandemic, DISEASE risk factors, COMMUNITY health services, ELECTRONIC health records, PREVENTIVE medicine
Abstract

ABSTRACT: Purpose: Qualitatively examine how community health clinics delivered cardiovascular disease (CVD) preventive care during COVID-19 using virtual care and related adaptations. Methods: Semi-structured interviews were conducted in 2021–2022 with nine clinician leaders from four clinics across the country that share an electronic health record. Interviews covered: (1) the pandemic's impact on preventive care delivery, (2) the adaptation and role of virtual care, and (3) management of CVD risk in this context. Collected data were analyzed using a thematic analysis approach. Results: Staff reported substantial pros and cons to virtual care for CVD risk management. It was seen as useful for general check-ins with patients. However, without current laboratory results and vital measurements, providers found it challenging to assess patient CVD risk and direct care accordingly. Conclusion: Findings add to the evolving evidence base that the necessary pivot to virtual care during the pandemic spurred innovations but also created limitations and delays in delivering appropriate preventive care. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Motivations of Young Adults for Improving Dietary Choices: Focus Group Findings Prior to the MENU GenY Dietary Change Trial

Author

Alexander, Gwen L., Lindberg, Nangel, Firemark, Alison L., Rukstalis, Margaret R., and McMullen, Carmit

Abstract

Background: Young adulthood is often associated with poor dietary habits that may increase risk of obesity and chronic diseases. As independence grows, little is known about strategies to help balance social, work, and education commitments that may override desires to incorporate healthful food choices. Objective: In advance of a randomized trial to test an online intervention targeting young adults, we sought to identify views and experiences with healthy eating, and specifically, eating more fruits and vegetables. Methods: We conducted 13 focus groups with 68 young adults in metropolitan Detroit (Henry Ford Health System) and rural Pennsylvania (Geisinger Health System). Randomly selected adults aged 21 to 30 years, using health system automated data, were sent recruitment letters. Questions were grounded in social cognitive theory and self-determination theory. Audiotapes were transcribed, content themes identified, coded, verified for reliability, and analyzed qualitatively. Results: Young adults' efforts to eat healthfully included three major themes of (1) motivations to create a healthy lifestyle, teach by example, feel better, and manage weight and future health problems; (2) learning to eat well from childhood, independent living, and peers; and (3) strategies to eat better through planning, tracking, and commitment. Discussion: We uncovered theory-based factors that facilitate healthy dietary behavior change among young adults, including managing their behavior through self-monitoring, goal-setting, small steps, meaningful reinforcements, and social opportunities. Conclusions: Targeted interventions encouraging reflection on personal values related to meaningful contemporary health benefits are likely to resonate with young adults, as will opportunities to receive and share new information.

Published
2018
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20. 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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21. Factors That Influence Selectionof Urinary Diversion Among Bladder Cancer Patients in 3 Community-based Integrated Health Care Systems

Author

Kwan, Marilyn L., Leo, Michael C., Danforth, Kim N., Weinmann, Sheila, Lee, Valerie S., Munneke, Julie R., Bulkley, Joanna E., Rosetti, Maureen O'Keeffe, Yi, David K., Banegas, Matthew P., Wagner, Matthew D., Williams, Stephen G., Aaronson, David S., Grant, Marcia, Krouse, Robert S., Gilbert, Scott M., and McMullen, Carmit K.

Published
2019
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22. “Just because it's hard, it doesn't mean that our patients can't benefit from it”: Evaluation of a Remote Patient Monitoring Program During the COVID-19 Pandemic (Preprint)

Author

Gunn, Rose, primary, Watkins, Shelby L., additional, Boston, Dave, additional, Rosales, A. Gabriela, additional, Massimino, Stefan, additional, Navale, Suparna, additional, Fitzpatrick, Stephanie L., additional, Dickerson, John, additional, Gold, Rachel, additional, Lee, George, additional, and McMullen, Carmit K., additional

Published
2023
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25. Context matters: the experience of 14 research teams in systematically reporting contextual factors important for practice change.

Author

Tomoaia-Cotisel, Andrada, Scammon, Debra L, Waitzman, Norman J, Cronholm, Peter F, Halladay, Jacqueline R, Driscoll, David L, Solberg, Leif I, Hsu, Clarissa, Tai-Seale, Ming, Hiratsuka, Vanessa, Shih, Sarah C, Fetters, Michael D, Wise, Christopher G, Alexander, Jeffrey A, Hauser, Diane, McMullen, Carmit K, Scholle, Sarah Hudson, Tirodkar, Manasi A, Schmidt, Laura, Donahue, Katrina E, Parchman, Michael L, and Stange, Kurt C

Subjects
Humans, Health Services Research, Organizational Innovation, Primary Health Care, change, context, generalizability, methods, organizational, patient-centered medical home, practice-based research, primary care, research design, transformation, validity, Clinical Research, Generic health relevance, change, organizational, Medical and Health Sciences, Studies in Human Society, General & Internal Medicine
Abstract

PurposeWe aimed to advance the internal and external validity of research by sharing our empirical experience and recommendations for systematically reporting contextual factors.MethodsFourteen teams conducting research on primary care practice transformation retrospectively considered contextual factors important to interpreting their findings (internal validity) and transporting or reinventing their findings in other settings/situations (external validity). Each team provided a table or list of important contextual factors and interpretive text included as appendices to the articles in this supplement. Team members identified the most important contextual factors for their studies. We grouped the findings thematically and developed recommendations for reporting context.ResultsThe most important contextual factors sorted into 5 domains: (1) the practice setting, (2) the larger organization, (3) the external environment, (4) implementation pathway, and (5) the motivation for implementation. To understand context, investigators recommend (1) engaging diverse perspectives and data sources, (2) considering multiple levels, (3) evaluating history and evolution over time, (4) looking at formal and informal systems and culture, and (5) assessing the (often nonlinear) interactions between contextual factors and both the process and outcome of studies. We include a template with tabular and interpretive elements to help study teams engage research participants in reporting relevant context.ConclusionsThese findings demonstrate the feasibility and potential utility of identifying and reporting contextual factors. Involving diverse stakeholders in assessing context at multiple stages of the research process, examining their association with outcomes, and consistently reporting critical contextual factors are important challenges for a field interested in improving the internal and external validity and impact of health care research.

Published
2013

37. 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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39. Geriatric assessment‐derived deficit accumulation and patient‐reported treatment burden in older adults with bladder cancer.

Author

Garg, Tullika, Frank, Katie, Johns, Alicia, Rabinowitz, Kirstin, Danella, John F., Kirchner, H. Lester, Nielsen, Matthew E., McMullen, Carmit K., Murphy, Terrence E., and Cohen, Harvey J.

Subjects
FRAIL elderly, CONFIDENCE intervals, CROSS-sectional method, GERIATRIC assessment, HEALTH outcome assessment, REGRESSION analysis, NON-muscle invasive bladder cancer, TUMOR classification, QUALITATIVE research, HOLISTIC medicine, EMPLOYEES' workload, AGING, QUESTIONNAIRES, DESCRIPTIVE statistics, RESEARCH funding, THEMATIC analysis, CANCER patient medical care, DISEASE complications, OLD age
Abstract

Background: When a person's workload of healthcare exceeds their resources, they experience treatment burden. At the intersection of cancer and aging, little is known about treatment burden. We evaluated the association between a geriatric assessment‐derived Deficit Accumulation Index (DAI) and patient‐reported treatment burden in older adults with early‐stage, non‐muscle‐invasive bladder cancer (NMIBC). Methods: We conducted a cross‐sectional survey of older adults with NMIBC (≥65 years). We calculated DAI using the Cancer and Aging Research Group's geriatric assessment and measured urinary symptoms using the Urogenital Distress Inventory‐6 (UDI‐6). The primary outcome was Treatment Burden Questionnaire (TBQ) score. A negative binomial regression with LASSO penalty was used to model TBQ. We further conducted qualitative thematic content analysis of responses to an open‐ended survey question ("What has been your Greatest Challenge in managing medical care for your bladder cancer") and created a joint display with illustrative quotes by DAI category. Results: Among 119 patients, mean age was 78.9 years (SD 7) of whom 56.3% were robust, 30.3% pre‐frail, and 13.4% frail. In the multivariable model, DAI and UDI‐6 were significantly associated with TBQ. Individuals with DAI above the median (>0.18) had TBQ scores 1.94 times greater than those below (adjusted IRR 1.94, 95% CI 1.33–2.82). Individuals with UDI‐6 greater than the median (25) had TBQ scores 1.7 times greater than those below (adjusted IRR 1.70, 95% CI 1.16–2.49). The top 5 themes in the Greatest Challenge question responses were cancer treatments (22.2%), cancer worry (19.2%), urination bother (18.2%), self‐management (18.2%), and appointment time (11.1%). Conclusions: DAI and worsening urinary symptoms were associated with higher treatment burden in older adults with NMIBC. These data highlight the need for a holistic approach that reconciles the burden from aging‐related conditions with that resulting from cancer treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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40. A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial

Author

DeBar, Lynn L., primary, Bushey, Michael A., additional, Kroenke, Kurt, additional, Bobb, Jennifer F., additional, Schoenbaum, Michael, additional, Thompson, Ella E., additional, Justice, Morgan, additional, Zatzick, Douglas, additional, Hamilton, Leah K., additional, McMullen, Carmit K., additional, Hallgren, Kevin A., additional, Benes, Lindsay L., additional, Forman, David P., additional, Caldeiro, Ryan M., additional, Brown, Ryan P., additional, Campbell, Noll L., additional, Anderson, Melissa L., additional, Son, Sungtaek, additional, Haggstrom, David A., additional, Whiteside, Lauren, additional, Schleyer, Titus K.L., additional, and Bradley, Katharine A., additional

Published
2023
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42. Economic Evaluation

Author

Smith, David H., O'Keeffe-Rosetti, Maureen, Leo, Michael C., Mayhew, Meghan, Benes, Lindsay, Bonifay, Allison, Deyo, Richard A., Elder, Charles R., Keefe, Francis J., McMullen, Carmit, Owen-Smith, Ashli, Trinacty, Connie M., Vollmer, William M., and DeBar, Lynn

Subjects
Adult, Analgesics, Opioid, Cognition, Cognitive Behavioral Therapy, Primary Health Care, Cost-Benefit Analysis, Quality of Life, Public Health, Environmental and Occupational Health, Humans, Quality-Adjusted Life Years, Chronic Pain, Article
Abstract

BACKGROUND: Chronic pain is prevalent and costly; cost-effective non-pharmacological approaches that reduce pain and improve patient functioning are needed. OBJECTIVE: Report the incremental cost-effectiveness ratio (ICER),compared to usual care, of cognitive behavioral therapy (CBT) aimed at improving functioning and pain among patients with chronic pain on long-term opioid treatment. DESIGN: Economic evaluation conducted alongside a pragmatic cluster randomized trial SUBJECTS: Adults with chronic pain on long-term opioid treatment (N=814) INTERVENTION: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorists, nurses) with additional support from physical therapists, and pharmacists. OUTCOME MEASURES: Cost per quality adjusted life year (QALY) gained, and cost per additional responder (≥ 30% improvement on standard scale assessment of Pain, Enjoyment, General Activity and Sleep). Costs were estimated as-delivered, and replication. RESULTS: Per patient intervention replication costs were $2,145 ($2,574 as-delivered). Those costs were completely offset by lower medical care costs; inclusive of the intervention, total medical care over follow-up was $1,841 lower for intervention patients. Intervention group patients also had greater QALY and responder gains than did controls. Supplemental analyses using pain-related medical care costs revealed incremental cost-effectiveness ratios (ICERs) of $35,000, and $53,000 per QALY (for replication, and as-delivered intervention costs, respectively); the ICER when excluding patients with outlier follow-up costs was $106,000 LIMITATIONS: Limited to one-year follow-up; identification of pain-related utilization potentially incomplete CONCLUSION: The intervention was the optimal choice at commonly accepted levels of willingness-to-pay for QALY gains; this finding was robust to sensitivity analyses.

Published
2022
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