10 research outputs found
The clinical benefit of ruxolitinib across patient subgroups: analysis of a placeboâcontrolled, Phase III study in patients with myelofibrosis
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/97529/1/bjh12274.pd
Effect of Ruxolitinib Therapy on Myelofibrosis-Related Symptoms and Other Patient-Reported Outcomes in COMFORT-I: A Randomized, Double-Blind, Placebo-Controlled Trial
The clinical benefit of ruxolitinib across patient subgroups: analysis of a placebo-controlled, Phase III study in patients with myelofibrosis
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/97529/1/bjh12274.pd
Long-term treatment with ruxolitinib for patients with myelofibrosis: 5-year update from the randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial
Abstract Background The randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial evaluated the JAK1/JAK2 inhibitor ruxolitinib in patients with intermediate-2/high-risk myelofibrosis. The primary and planned 3-year analyses of COMFORT-I data demonstrated that ruxolitinibâthe first myelofibrosis-approved therapyâreduced splenomegaly and prolonged overall survival versus placebo. Here, we present the final 5-year results. Methods Patients managed in Australia, Canada, and the USA were randomized centrally (interactive voice response system) 1:1 to oral ruxolitinib twice daily (15 or 20Â mg per baseline platelet counts) or placebo. Investigators and patients were blinded to treatment. The secondary endpoints evaluated in this analysis were durability of a â„35% reduction from baseline in spleen volume (spleen response) and overall survival, evaluated in the intent-to-treat population. Safety was evaluated in patients who received study treatment. Results Patients were randomized (September 2009âApril 2010) to ruxolitinib (nâ=â155) or placebo (nâ=â154). At termination, 27.7% of ruxolitinib-randomized patients and 25.2% (28/111) who crossed over from placebo were on treatment; no patients remained on placebo. Patients randomized to ruxolitinib had a median spleen response duration of 168.3Â weeks and prolonged median overall survival versus placebo (ruxolitinib group, not reached; placebo group, 200Â weeks; HR, 0.69; 95% CI, 0.50â0.96; Pâ=â0.025) despite the crossover to ruxolitinib. The ruxolitinib safety profile remained consistent with previous analyses. The most common new-onset all-grade nonhematologic adverse events starting <12 versus â„48Â months after ruxolitinib initiation were fatigue (29.0 vs 33.3%) and diarrhea (27.8 vs 14.6%). New-onset grade 3 or 4 anemia and thrombocytopenia both primarily occurred within the first 6Â months, with no cases after 42Â months. The most common treatment-emergent adverse event-related deaths in the ruxolitinib-randomized group were sepsis (2.6%), disease progression (1.9%), and pneumonia (1.9%). Conclusion The final COMFORT-I results continue to support ruxolitinib as an effective treatment for patients with intermediate-2/high-risk MF. Trial registration ClinicalTrials.gov, NCT0095228
Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis:Results of a median 3-year follow-up of COMFORT-I
In the phase III COMFORT-I study, the Janus kinase 1 (JAK1)/JAK2 inhibitor ruxolitinib provided significant improvements in splenomegaly, key symptoms, and quality-of-life measures and was associated with an overall survival benefit relative to placebo in patients with intermediate-2 or high-risk myelofibrosis. This planned analysis assessed the long-term efficacy and safety of ruxolitinib at a median follow-up of 149 weeks. At data cutoff, approximately 50% of patients originally randomized to ruxolitinib remained on treatment whereas all patients originally assigned to placebo had discontinued or crossed over to ruxolitinib. At week 144, mean spleen volume reduction was 34% with ruxolitinib. Previously observed improvements in quality-of-life measures were sustained with longer-term ruxolitinib therapy. Overall survival continued to favor ruxolitinib despite the majority of placebo patients crossing over to ruxolitinib [hazard ratio 0.69 (95% confidence interval: 0.46â1.03); P=0.067]. Exploratory analyses suggest that crossover may have contributed to an underestimation of the true survival difference between the treatment groups. Ruxolitinib continued to be generally well tolerated; there was no pattern of worsening grade â„3 anemia or thrombocytopenia with longer-term ruxolitinib exposure. These longer-term data continue to support the efficacy and safety of ruxolitinib in patients with myelofibrosis. The study is registered at clinicaltrials.gov: NCT00952289
Phase II Trial of Mapatumumab, a Fully Human Agonist Monoclonal Antibody to Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand Receptor 1 (TRAIL-R1), in Combination With Paclitaxel and Carboplatin in Patients With Advanced NonâSmall-Cell Lung Cancer
Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies.
Prior to Janus kinase inhibitors, available therapies for myelofibrosis were generally supportive and did not improve survival. This analysis compares efficacy outcomes of patients with myelofibrosis in the control arms (placebo [n=154] and best available therapy [n=73]) from the two phase 3 COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (COMFORT) studies. Spleen volume was assessed by magnetic resonance imaging/computed tomography at baseline and every 12 weeks through week 72; spleen length was assessed by palpation at each study visit. Health-related quality of life and symptoms were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items at baseline and in weeks 4, 8, 12, 16 and 24 in COMFORT-I and in weeks 8, 16, 24 and 48 in COMFORT-II. The demographic and baseline characteristics were similar between the control arms of the two studies. One patient who received placebo and no patients who received best available therapy had a â„35% reduction in spleen volume from baseline at week 24. At 24 weeks, neither placebo nor best available therapy had produced clinically meaningful changes in global quality of life or symptom scales. Non-hematologic adverse events were mostly grade 1/2; the most frequently reported adverse events in each group were abdominal pain, fatigue, peripheral edema and diarrhea. These data suggest that non-Janus kinase inhibitor therapies provide little improvement in splenomegaly, symptoms or quality of life as compared with placebo. Both COMFORT-I (NCT00952289) and COMFORT-II (NCT00934544) studies have been appropriately registered with clinicaltrials.gov
Proceedings of the 8th Annual Conference on the Science of Dissemination and Implementation
Table of contents
A1 Introduction to the 8th Annual Conference on the Science of Dissemination and Implementation: Optimizing Personal and Population Health
David Chambers, Lisa Simpson
D1 Discussion forum: Population health D&I research
Felicia Hill-Briggs
D2 Discussion forum: Global health D&I research
Gila Neta, Cynthia Vinson
D3 Discussion forum: Precision medicine and D&I research
David Chambers
S1 Predictors of community therapistsâ use of therapy techniques in a large public mental health system
Rinad Beidas, Steven Marcus, Gregory Aarons, Kimberly Hoagwood, Sonja Schoenwald, Arthur Evans, Matthew Hurford, Ronnie Rubin, Trevor Hadley, Frances Barg, Lucia Walsh, Danielle Adams, David Mandell
S2 Implementing brief cognitive behavioral therapy (CBT) in primary care: Clinicians' experiences from the field
Lindsey Martin, Joseph Mignogna, Juliette Mott, Natalie Hundt, Michael Kauth, Mark Kunik, Aanand Naik, Jeffrey Cully
S3 Clinician competence: Natural variation, factors affecting, and effect on patient outcomes
Alan McGuire, Dominique White, Tom Bartholomew, John McGrew, Lauren Luther, Angie Rollins, Michelle Salyers
S4 Exploring the multifaceted nature of sustainability in community-based prevention: A mixed-method approach
Brittany Cooper, Angie Funaiole
S5 Theory informed behavioral health integration in primary care: Mixed methods evaluation of the implementation of routine depression and alcohol screening and assessment
Julie Richards, Amy Lee, Gwen Lapham, Ryan Caldeiro, Paula Lozano, Tory Gildred, Carol Achtmeyer, Evette Ludman, Megan Addis, Larry Marx, Katharine Bradley
S6 Enhancing the evidence for specialty mental health probation through a hybrid efficacy and implementation study
Tonya VanDeinse, Amy Blank Wilson, Burgin Stacey, Byron Powell, Alicia Bunger, Gary Cuddeback
S7 Personalizing evidence-based child mental health care within a fiscally mandated policy reform
Miya Barnett, Nicole Stadnick, Lauren Brookman-Frazee, Anna Lau
S8 Leveraging an existing resource for technical assistance: Community-based supervisors in public mental health
Shannon Dorsey, Michael Pullmann
S9 SBIRT implementation for adolescents in urban federally qualified health centers: Implementation outcomes
Shannon Mitchell, Robert Schwartz, Arethusa Kirk, Kristi Dusek, Marla Oros, Colleen Hosler, Jan Gryczynski, Carolina Barbosa, Laura Dunlap, David Lounsbury, Kevin O'Grady, Barry Brown
S10 PANEL: Tailoring Implementation Strategies to Context - Expert recommendations for tailoring strategies to context
Laura Damschroder, Thomas Waltz, Byron Powell
S11 PANEL: Tailoring Implementation Strategies to Context - Extreme facilitation: Helping challenged healthcare settings implement complex programs
Mona Ritchie
S12 PANEL: Tailoring Implementation Strategies to Context - Using menu-based choice tasks to obtain expert recommendations for implementing three high-priority practices in the VA
Thomas Waltz
S13 PANEL: The Use of Technology to Improve Efficient Monitoring of Implementation of Evidence-based Programs - Siri, rate my therapist: Using technology to automate fidelity ratings of motivational interviewing
David Atkins, Zac E. Imel, Bo Xiao, DoÄan Can, Panayiotis Georgiou, Shrikanth Narayanan
S14 PANEL: The Use of Technology to Improve Efficient Monitoring of Implementation of Evidence-based Programs - Identifying indicators of implementation quality for computer-based ratings
Cady Berkel, Carlos Gallo, Irwin Sandler, C. Hendricks Brown, Sharlene Wolchik, Anne Marie Mauricio
S15 PANEL: The Use of Technology to Improve Efficient Monitoring of Implementation of Evidence-based Programs - Improving implementation of behavioral interventions by monitoring emotion in spoken speech
Carlos Gallo, C. Hendricks Brown, Sanjay Mehrotra
S16 Scorecards and dashboards to assure data quality of health management information system (HMIS) using R
Dharmendra Chandurkar, Siddhartha Bora, Arup Das, Anand Tripathi, Niranjan Saggurti, Anita Raj
S17 A big data approach for discovering and implementing patient safety insights
Eric Hughes, Brian Jacobs, Eric Kirkendall
S18 Improving the efficacy of a depression registry for use in a collaborative care model
Danielle Loeb, Katy Trinkley, Michael Yang, Andrew Sprowell, Donald Nease
S19 Measurement feedback systems as a strategy to support implementation of measurement-based care in behavioral health
Aaron Lyon, Cara Lewis, Meredith Boyd, Abigail Melvin, Semret Nicodimos, Freda Liu, Nathanial Jungbluth
S20 PANEL: Implementation Science and Learning Health Systems: Intersections and Commonalities - Common loop assay: Methods of supporting learning collaboratives
Allen Flynn
S21 PANEL: Implementation Science and Learning Health Systems: Intersections and Commonalities - Innovating audit and feedback using message tailoring models for learning health systems
Zach Landis-Lewis
S22 PANEL: Implementation Science and Learning Health Systems: Intersections and Commonalities - Implementation science and learning health systems: Connecting the dots
Anne Sales
S23 Facilitation activities of Critical Access Hospitals during TeamSTEPPS implementation
Jure Baloh, Marcia Ward, Xi Zhu
S24 Organizational and social context of federally qualified health centers and variation in maternal depression outcomes
Ian Bennett, Jurgen Unutzer, Johnny Mao, Enola Proctor, Mindy Vredevoogd, Ya-Fen Chan, Nathaniel Williams, Phillip Green
S25 Decision support to enhance treatment of hospitalized smokers: A randomized trial
Steven Bernstein, June-Marie Rosner, Michelle DeWitt, Jeanette Tetrault, James Dziura, Allen Hsiao, Scott Sussman, Patrick OâConnor, Benjamin Toll
S26 PANEL: Developing Sustainable Strategies for the Implementation of Patient-Centered Care across Diverse US Healthcare Systems - A patient-centered approach to successful community transition after catastrophic injury
Michael Jones, Julie Gassaway
S27 PANEL: Developing Sustainable Strategies for the Implementation of Patient-Centered Care across Diverse US Healthcare Systems - Conducting PCOR to integrate mental health and cancer screening services in primary care
Jonathan Tobin
S28 PANEL: Developing Sustainable Strategies for the Implementation of Patient-Centered Care across Diverse US Healthcare Systems - A comparative effectiveness trial of optimal patient-centered care for US trauma care systems
Douglas Zatzick
S29 Preferences for in-person communication among patients in a multi-center randomized study of in-person versus telephone communication of genetic test results for cancer susceptibility
Angela R Bradbury, Linda Patrick-Miller, Brian Egleston, Olufunmilayo I Olopade, Michael J Hall, Mary B Daly, Linda Fleisher, Generosa Grana, Pamela Ganschow, Dominique Fetzer, Amanda Brandt, Dana Farengo-Clark, Andrea Forman, Rikki S Gaber, Cassandra Gulden, Janice Horte, Jessica Long, Rachelle Lorenz Chambers, Terra Lucas, Shreshtha Madaan, Kristin Mattie, Danielle McKenna, Susan Montgomery, Sarah Nielsen, Jacquelyn Powers, Kim Rainey, Christina Rybak, Michelle Savage, Christina Seelaus, Jessica Stoll, Jill Stopfer, Shirley Yao and Susan Domchek
S30 Working towards de-implementation: A mixed methods study in breast cancer surveillance care
Erin Hahn, Corrine Munoz-Plaza, Jianjin Wang, Jazmine Garcia Delgadillo, Brian Mittman Michael Gould
S31Integrating evidence-based practices for increasing cancer screenings in safety-net primary care systems: A multiple case study using the consolidated framework for implementation research
Shuting (Lily) Liang, Michelle C. Kegler, Megan Cotter, Emily Phillips, April Hermstad, Rentonia Morton, Derrick Beasley, Jeremy Martinez, Kara Riehman
S32 Observations from implementing an mHealth intervention in an FQHC
David Gustafson, Lisa Marsch, Louise Mares, Andrew Quanbeck, Fiona McTavish, Helene McDowell, Randall Brown, Chantelle Thomas, Joseph Glass, Joseph Isham, Dhavan Shah
S33 A multicomponent intervention to improve primary care provider adherence to chronic opioid therapy guidelines and reduce opioid misuse: A cluster randomized controlled trial protocol
Jane Liebschutz, Karen Lasser
S34 Implementing collaborative care for substance use disorders in primary care: Preliminary findings from the summit study
Katherine Watkins, Allison Ober, Sarah Hunter, Karen Lamp, Brett Ewing
S35 Sustaining a task-shifting strategy for blood pressure control in Ghana: A stakeholder analysis
Juliet Iwelunmor, Joyce Gyamfi, Sarah Blackstone, Nana Kofi Quakyi, Jacob Plange-Rhule, Gbenga Ogedegbe
S36 Contextual adaptation of the consolidated framework for implementation research (CFIR) in a tobacco cessation study in Vietnam
Pritika Kumar, Nancy Van Devanter, Nam Nguyen, Linh Nguyen, Trang Nguyen, Nguyet Phuong, Donna Shelley
S37 Evidence check: A knowledge brokering approach to systematic reviews for policy
Sian Rudge
S38 Using Evidence Synthesis to Strengthen Complex Health Systems in Low- and Middle-Income Countries
Etienne Langlois
S39 Does it matter: timeliness or accuracy of results? The choice of rapid reviews or systematic reviews to inform decision-making
Andrea Tricco
S40 Evaluation of the veterans choice program using lean six sigma at a VA medical center to identify benefits and overcome obstacles
Sherry Ball, Anne Lambert-Kerzner, Christine Sulc, Carol Simmons, Jeneen Shell-Boyd, Taryn Oestreich, Ashley O'Connor, Emily Neely, Marina McCreight, Amy Labebue, Doreen DiFiore, Diana Brostow, P. Michael Ho, David Aron
S41 The influence of local context on multi-stakeholder alliance quality improvement activities: A multiple case study
Jillian Harvey, Megan McHugh, Dennis Scanlon
S42 Increasing physical activity in early care and education: Sustainability via active garden education (SAGE)
Rebecca Lee, Erica Soltero, Nathan Parker, Lorna McNeill, Tracey Ledoux
S43 Marking a decade of policy implementation: The successes and continuing challenges of a provincial school food and nutrition policy in Canada
Jessie-Lee McIsaac, Kate MacLeod, Nicole Ata, Sherry Jarvis, Sara Kirk
S44 Use of research evidence among state legislators who prioritize mental health and substance abuse issues
Jonathan Purtle, Elizabeth Dodson, Ross Brownson
S45 PANEL: Effectiveness-Implementation Hybrid Designs: Clarifications, Refinements, and Additional Guidance Based on a Systematic Review and Reports from the Field - Hybrid type 1 designs
Brian Mittman, Geoffrey Curran
S46 PANEL: Effectiveness-Implementation Hybrid Designs: Clarifications, Refinements, and Additional Guidance Based on a Systematic Review and Reports from the Field - Hybrid type 2 designs
Geoffrey Curran
S47 PANEL: Effectiveness-Implementation Hybrid Designs: Clarifications, Refinements, and Additional Guidance Based on a Systematic Review and Reports from the Field - Hybrid type 3 designs
Jeffrey Pyne
S48 Linking team level implementation leadership and implementation climate to individual level attitudes, behaviors, and implementation outcomes
Gregory Aarons, Mark Ehrhart, Elisa Torres
S49 Pinpointing the specific elements of local context that matter most to implementation outcomes: Findings from qualitative comparative analysis in the RE-inspire study of VA acute stroke care
Edward Miech
S50 The GO score: A new context-sensitive instrument to measure group organization level for providing and improving care
Edward Miech
S51 A research network approach for boosting implementation and improvement
Kathleen Stevens, I.S.R.N. Steering Council
S52 PANEL: Qualitative methods in D&I Research: Value, rigor and challenge - The value of qualitative methods in implementation research
Alison Hamilton
S53 PANEL: Qualitative methods in D&I Research: Value, rigor and challenge - Learning evaluation: The role of qualitative methods in dissemination and implementation research
Deborah Cohen
S54 PANEL: Qualitative methods in D&I Research: Value, rigor and challenge - Qualitative methods in D&I research
Deborah Padgett
S55 PANEL: Maps & models: The promise of network science for clinical D&I - Hospital network of sharing patients with acute and chronic diseases in California
Alexandra Morshed
S56 PANEL: Maps & models: The promise of network science for clinical D&I - The use of social network analysis to identify dissemination targets and enhance D&I research study recruitment for pre-exposure prophylaxis for HIV (PrEP) among men who have sex with men
Rupa Patel
S57 PANEL: Maps & models: The promise of network science for clinical D&I - Network and organizational factors related to the adoption of patient navigation services among rural breast cancer care providers
Beth Prusaczyk
S58 A theory of de-implementation based on the theory of healthcare professionalsâ behavior and intention (THPBI) and the becker model of unlearning
David C. Aron, Divya Gupta, Sherry Ball
S59 Observation of registered dietitian nutritionist-patient encounters by dietetic interns highlights low awareness and implementation of evidence-based nutrition practice guidelines
Rosa Hand, Jenica Abram, Taylor Wolfram
S60 Program sustainability action planning: Building capacity for program sustainability using the program sustainability assessment tool
Molly Hastings, Sarah Moreland-Russell
S61 A review of D&I study designs in published study protocols
Rachel Tabak, Alex Ramsey, Ana Baumann, Emily Kryzer, Katherine Montgomery, Ericka Lewis, Margaret Padek, Byron Powell, Ross Brownson
S62 PANEL: Geographic variation in the implementation of public health services: Economic, organizational, and network determinants - Model simulation techniques to estimate the cost of implementing foundational public health services
Cezar Brian Mamaril, Glen Mays, Keith Branham, Lava Timsina
S63 PANEL: Geographic variation in the implementation of public health services: Economic, organizational, and network determinants - Inter-organizational network effects on the implementation of public health services
Glen Mays, Rachel Hogg
S64 PANEL: Building capacity for implementation and dissemination of the communities that care prevention system at scale to promote evidence-based practices in behavioral health - Implementation fidelity, coalition functioning, and community prevention system transformation using communities that care
Abigail Fagan, Valerie Shapiro, Eric Brown
S65 PANEL: Building capacity for implementation and dissemination of the communities that care prevention system at scale to promote evidence-based practices in behavioral health - Expanding capacity for implementation of communities that care at scale using a web-based, video-assisted training system
Kevin Haggerty, David Hawkins
S66 PANEL: Building capacity for implementation and dissemination of the communities that care prevention system at scale to promote evidence-based practices in behavioral health - Effects of communities that care on reducing youth behavioral health problems
Sabrina Oesterle, David Hawkins, Richard Catalano
S68 When interventions end: the dynamics of intervention de-adoption and replacement
Virginia McKay, M. Margaret Dolcini, Lee Hoffer
S69 Results from next-d: can a disease specific health plan reduce incident diabetes development among a national sample of working-age adults with pre-diabetes?
Tannaz Moin, Jinnan Li, O. Kenrik Duru, Susan Ettner, Norman Turk, Charles Chan, Abigail Keckhafer, Robert Luchs, Sam Ho, Carol Mangione
S70 Implementing smoking cessation interventions in primary care settings (STOP): using the interactive systems framework
Peter Selby, Laurie Zawertailo, Nadia Minian, Dolly Balliunas, Rosa Dragonetti, Sarwar Hussain, Julia Lecce
S71 Testing the Getting To Outcomes implementation support intervention in prevention-oriented, community-based settings
Matthew Chinman, Joie Acosta, Patricia Ebener, Patrick S Malone, Mary Slaughter
S72 Examining the reach of a multi-component farmersâ market implementation approach among low-income consumers in an urban context
Darcy Freedman, Susan Flocke, Eunlye Lee, Kristen Matlack, Erika Trapl, Punam Ohri-Vachaspati, Morgan Taggart, Elaine Borawski
S73 Increasing implementation of evidence-based health promotion practices at large workplaces: The CEOs Challenge
Amanda Parrish, Jeffrey Harris, Marlana Kohn, Kristen Hammerback, Becca McMillan, Peggy Hannon
S74 A qualitative assessment of barriers to nutrition promotion and obesity prevention in childcare
Taren Swindle, Geoffrey Curran, Leanne Whiteside-Mansell, Wendy Ward
S75 Documenting institutionalization of a health communication intervention in African American churches
Cheryl Holt, Sheri Lou Santos, Erin Tagai, Mary Ann Scheirer, Roxanne Carter, Janice Bowie, Muhiuddin Haider, Jimmie Slade, Min Qi Wang
S76 Reduction in hospital utilization by underserved patients through use of a community-medical home
Andrew Masica, Gerald Ogola, Candice Berryman, Kathleen Richter
S77 Sustainability of evidence-based lay health advisor programs in African American communities: A mixed methods investigation of the National Witness Project
Rachel Shelton, Lina Jandorf, Deborah Erwin
S78 Predicting the long-term uninsured population and analyzing their gaps in physical access to healthcare in South Carolina
Khoa Truong
S79 Using an evidence-based parenting intervention in churches to prevent behavioral problems among Filipino youth: A randomized pilot study
Joyce R. Javier, Dean Coffey, Sheree M. Schrager, Lawrence Palinkas, Jeanne Miranda
S80 Sustainability of elementary school-based health centers in three health-disparate southern communities
Veda Johnson, Valerie Hutcherson, Ruth Ellis
S81 Childhood obesity prevention partnership in Louisville: creative opportunities to engage families in a multifaceted approach to obesity prevention
Anna Kharmats, Sandra Marshall-King, Monica LaPradd, Fannie Fonseca-Becker
S82 Improvements in cervical cancer prevention found after implementation of evidence-based Latina prevention care management program
Deanna Kepka, Julia Bodson, Echo Warner, Brynn Fowler
S83 The OneFlorida data trust: Achieving health equity through research & training capacity building
Elizabeth Shenkman, William Hogan, Folakami Odedina, Jessica De Leon, Monica Hooper, Olveen Carrasquillo, Renee Reams, Myra Hurt, Steven Smith, Jose Szapocznik, David Nelson, Prabir Mandal
S84 Disseminating and sustaining medical-legal partnerships: Shared value and social return on investment
James Teufe