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https://www.readbyqxmd.com/read/29113955/treatment-of-fatigue-with-methylphenidate-modafinil-and-amantadine-in-multiple-sclerosis-triumphant-ms-study-design-for-a-pragmatic-randomized-double-blind-crossover-clinical-trial
#1
Bardia Nourbakhsh, Nisha Revirajan, Emmanuelle Waubant
BACKGROUND: Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. OBJECTIVE: To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used fatigue medications in patients with MS...
November 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29052427/the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making-an-interview-with-marc-berger
#2
Marc L Berger
Marc L Berger, MD, is a retired, part-time consultant. He recently became Chair of the Real World Evidence Advisory Board for SHYFT Analytics. Over a 25-year industry career, Marc has held senior-level positions at Pfizer, Inc., OptumInsight, Eli Lilly and Company, and Merck & Co., Inc. His professional activities have included serving on committees for Center for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Drug Information Association (DIA), and the editorial advisory boards of several journals...
October 20, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/29044479/the-strategies-to-reduce-injuries-and-develop-confidence-in-elders-intervention-falls-risk-factor-assessment-and-management-patient-engagement-and-nurse-co-management
#3
David B Reuben, Priscilla Gazarian, Neil Alexander, Katy Araujo, Dorothy Baker, Jonathan F Bean, Chad Boult, Peter Charpentier, Pamela Duncan, Nancy Latham, Rosanne M Leipzig, Lisa M Quintiliani, Thomas Storer, Siobhan McMahon
In response to the epidemic of falls and serious falls-related injuries in older persons, in 2014, the Patient Centered Outcomes Research Institute (PCORI) and the National Institute on Aging funded a pragmatic trial, Strategies to Reduce Injuries and Develop confidence in Elders (STRIDE) to compare the effects of a multifactorial intervention with those of an enhanced usual care intervention. The STRIDE multifactorial intervention consists of five major components that registered nurses deliver in the role of falls care managers, co-managing fall risk in partnership with patients and their primary care providers (PCPs)...
October 17, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28987615/improving-the-quality-of-depression-and-pain-care-in-multiple-sclerosis-using-collaborative-care-the-ms-care-trial-protocol
#4
Dawn M Ehde, Kevin N Alschuler, Mark D Sullivan, Ivan P Molton, Marcia A Ciol, Charles H Bombardier, Mary C Curran, Kevin J Gertz, Annette Wundes, Jesse R Fann
BACKGROUND AND OBJECTIVES: Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting...
October 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28949867/how-are-pcori-funded-researchers-engaging-patients-in-research-and-what-are-the-ethical-implications
#5
Lauren E Ellis, Nancy E Kass
BACKGROUND: Despite growing interest in patient engagement in research, there are few empirical investigations of the nature of engagement and its effects. This information is important, not only to inform practical decisions researchers and funders must make, but also to inform discussion of the ethical implications of engaging patients, which has received little attention to date. METHODS: The aim of this study was to characterize patient engagement in research funded by the Patient-Centered Outcomes Research Institute (PCORI) as a step toward enhancing current understanding of the nature and effects of engagement and prompting an in-depth consideration of the ethical implications of engaging patients in research...
January 2017: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/28870836/patients-experience-with-non-surgical-treatment-for-lumbar-spinal-stenosis-a-qualitative-study
#6
Allyn M Bove, Andrew D Lynch, Carlo Ammendolia, Michael Schneider
BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) is a highly prevalent disease in older adults that causes significant limitations in walking and other daily activities. There is a lack of research into optimal non-surgical treatment approaches for LSS. PURPOSE: The purpose of this qualitative study is to assess the opinions of participants in a randomized clinical trial of nonsurgical LSS treatments regarding the interventions they received, factors contributing to adherence to the interventions, and methods of outcomes assessment...
September 21, 2017: Spine Journal: Official Journal of the North American Spine Society
https://www.readbyqxmd.com/read/28862395/phelan-mcdermid-syndrome-data-network-integrating-patient-reported-outcomes-with-clinical-notes-and-curated-genetic-reports
#7
Cartik Kothari, Maxime Wack, Claire Hassen-Khodja, Sean Finan, Guergana Savova, Megan O'Boyle, Geraldine Bliss, Andria Cornell, Elizabeth J Horn, Rebecca Davis, Jacquelyn Jacobs, Isaac Kohane, Paul Avillach
The heterogeneity of patient phenotype data are an impediment to the research into the origins and progression of neuropsychiatric disorders. This difficulty is compounded in the case of rare disorders such as Phelan-McDermid Syndrome (PMS) by the paucity of patient clinical data. PMS is a rare syndromic genetic cause of autism and intellectual deficiency. In this paper, we describe the Phelan-McDermid Syndrome Data Network (PMS_DN), a platform that facilitates research into phenotype-genotype correlation and progression of PMS by: a) integrating knowledge of patient phenotypes extracted from Patient Reported Outcomes (PRO) data and clinical notes-two heterogeneous, underutilized sources of knowledge about patient phenotypes-with curated genetic information from the same patient cohort and b) making this integrated knowledge, along with a suite of statistical tools, available free of charge to authorized investigators on a Web portal https://pmsdn...
September 1, 2017: American Journal of Medical Genetics. Part B, Neuropsychiatric Genetics
https://www.readbyqxmd.com/read/28815145/evolving-research-data-sharing-networks-to-clinical-app-sharing-networks
#8
Kavishwar B Wagholikar, Rahul Jain, Eliel Oliveira, Joshua Mandel, Jeffery Klann, Ricardo Colas, Prasad Patil, Kuladip Yadav, Kenneth D Mandl, Thomas Carton, Shawn N Murphy
Research networks for data sharing are growing into a large platform for pragmatic clinical trials to generate quality evidence for shared medical decision-making. Institutions partnering in the networks have made large investments in developing the infrastructure for sharing data. We investigate whether institutions partnering on Patient-Centered Outcomes Research Institute's (PCORI) network can share clinical apps. At two different sites, we imported patient data in PCORI's clinical data model (CDM) format into i2b2 repositories, and adapted the SMART-on-FHIR cell to perform CDM-to-FHIR translation, serving demographics, laboratory results and diagnoses...
2017: AMIA Summits on Translational Science Proceedings
https://www.readbyqxmd.com/read/28755961/patient-engagement-in-the-design-and-execution-of-urologic-oncology-research
#9
REVIEW
Daniel J Lee, Svetlana Avulova, Ralph Conwill, Daniel A Barocas
INTRODUCTION: There have been significant effort and financial support to engage patients in the design and execution of medical research. However, little is known about the relative benefits or potential impact of involving patients in research, most efficient practices and systems to enhance their involvement, and potential barriers and challenges that are involved with engaging patients. In this review, we will discuss the value of patient centered research, review the challenges that many of these studies faced, and highlight potential future opportunities to enhance patient involvement in urologic research...
July 26, 2017: Urologic Oncology
https://www.readbyqxmd.com/read/28686060/show-me-the-money-an-analysis-of-underserved-stakeholders-funding-priorities-in-patient-centered-outcomes-research-domains
#10
Stephanie Solomon Cargill, Lauren Lyn Baker, Susan Dorr Goold
AIM: Develop an accessible exercise to engage underserved populations about research funding priorities; analyze the criteria they use to prioritize research; contrast these criteria to those currently used by Patient Centered Outcomes Research Institute (PCORI). MATERIALS & METHODS: Academic and community partners collaborated to develop an Ipad exercise to facilitate group deliberation about PCOR funding priorities. Sixteen groups (n = 183) of underserved individuals in both urban and rural areas participated...
July 7, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/28686055/a-stakeholder-informed-randomized-controlled-comparative-effectiveness-study-of-an-order-prescribing-intervention-to-improve-colony-stimulating-factor-use-for-cancer-patients-receiving-myelosuppressive-chemotherapy-the-tracer-study
#11
Aasthaa Bansal, Sean D Sullivan, Dawn L Hershman, Gary H Lyman, William E Barlow, Jeannine S McCune, Scott D Ramsey
Colony stimulating factors (CSF) are widely prescribed to avoid febrile neutropenia (FN) among cancer patients receiving chemotherapy, but studies show their use is often not consistent with practice guidelines. In addition, there is limited high quality evidence assessing benefits and harms of primary prophylactic-CSF (PP-CSF) in the setting of chemotherapy that poses an intermediate risk of FN. To address these issues, with funding from the Patient Centered Outcomes Research Institute (PCORI) and the National Cancer Institute's Community Oncology Research Program, SWOG is sponsoring a prospective, cluster randomized controlled pragmatic trial of an automated order entry protocol for PP-CSF among patients with breast, lung and colorectal cancer receiving myelosuppressive chemotherapy, with a nested randomized controlled trial of PP-CSF for patients receiving intermediate risk chemotherapy...
July 7, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/28570481/the-relationship-of-sociodemographic-and-psychological-variables-with-chronic-pain-variables-in-a-low-income-population
#12
Andrea K Newman, Benjamin P Van Dyke, Calia A Torres, Jacob W Baxter, Joshua C Eyer, Shweta Kapoor, Beverly E Thorn
Chronic pain is a pervasive condition that is complicated by economic, educational, and racial disparities. This study analyzes key factors associated with chronic pain within an understudied and underserved population. The sample is characterized by a triple disparity with respect to income, education/literacy, and racial barriers that substantially increase the vulnerability to the negative consequences of chronic pain. The study examined the pretreatment data of 290 participants enrolled in the Learning About My Pain trial, a randomized controlled comparative effectiveness trial of psychosocial interventions (B...
September 2017: Pain
https://www.readbyqxmd.com/read/28500572/methods-and-impact-of-engagement-in-research-from-theory-to-practice-and-back-again-early-findings-from-the-patient-centered-outcomes-research-institute
#13
Laura Forsythe, Andrea Heckert, Mary Kay Margolis, Suzanne Schrandt, Lori Frank
PURPOSE: Since 2012, PCORI has been funding patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders in the research, a requirement that is unique among the US funders of clinical research. This paper presents PCORI's evaluation framework for assessing the short- and long-term impacts of engagement; describes engagement in PCORI projects (types of stakeholders engaged, when in the research process they are engaged and how they are engaged, contributions of their engagement); and identifies the effects of engagement on study design, processes, and outcomes selection, as reported by both PCORI-funded investigators and patient and other stakeholder research partners...
May 12, 2017: Quality of Life Research
https://www.readbyqxmd.com/read/28450194/design-and-baseline-data-from-a-pcori-funded-randomized-controlled-trial-of-family-centered-tailoring-of-diabetes-self-management-resources
#14
Rosanna Fiallo-Scharer, Mari Palta, Betty A Chewning, Tim Wysocki, Tosha B Wetterneck, Elizabeth D Cox
This article describes the methodology, recruitment, participant characteristics, and sustained, intensive stakeholder engagement for Project ACE (Achieving control, Connecting resources, Empowering families). Project ACE is a randomized controlled trial of children and youth ages 8-16 with type 1 diabetes evaluating the impact of tailored self-management resources on hemoglobin A1c (A1c) and quality of life (QOL). Despite strong evidence that controlling A1c reduces long-term complications, <25% of US youth with type 1 diabetes meet A1c targets...
July 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28383301/re-readability-assessment-of-pcori-public-abstracts-in-relation-to-accessibility
#15
Joanna E Siegel, Christopher C Gayer, Jean R Slutsky
No abstract text is available yet for this article.
November 2017: Epidemiology
https://www.readbyqxmd.com/read/28369722/components-of-comprehensive-and-effective-transitional-care
#16
Mary D Naylor, Elizabeth C Shaid, Deborah Carpenter, Brianna Gass, Carol Levine, Jing Li, Ann Malley, Kathleen McCauley, Huong Q Nguyen, Heather Watson, Jane Brock, Brian Mittman, Brian Jack, Suzanne Mitchell, Becky Callicoatte, John Schall, Mark V Williams
Transitional care (TC) has received widespread attention from researchers, health system leaders, clinicians, and policy makers as they attempt to improve health outcomes and reduce preventable hospital readmissions, yet little is known about the critical elements of effective TC and how they relate to patients' and caregivers' needs and experiences. To address this gap, the Patient-Centered Outcomes Research Institute (PCORI) funded a national study, Achieving patient-centered Care and optimized Health In care transitions by Evaluating the Value of Evidence (Project ACHIEVE)...
June 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28364384/speaking-up-how-patient-and-physician-voices-shaped-a-trial-to-improve-goals-of-care-discussions
#17
Rachel Solomon, Cardinale Smith, Jay Kallio, Amy Fenollosa, Barbara Benerofe, Laurence Jones, Kerin Adelson, Jason P Gonsky, Carolyn Messner, Nina A Bickell
BACKGROUND: Patients with advanced cancer benefit from early goals-of-care (GoC) conversations, but few facilitators are known. OBJECTIVE: We describe the process and outcomes of involving patient and physician stakeholders in the design and development of a trial, funded by the Patient-Centered Outcomes Research Institute (PCORI), to enhance oncologists' communication skills and their propensity to facilitate productive, meaningful GoC discussions with patients with advanced cancer...
August 2017: Patient
https://www.readbyqxmd.com/read/28342989/patient-engagement-and-study-design-of-prop-up-a-multi-site-patient-centered-prospective-observational-study-of-patients-undergoing-hepatitis-c-treatment
#18
Donna M Evon, Carol E Golin, Paul Stewart, Michael W Fried, Shani Alston, Bryce Reeve, Anna S Lok, Richard K Sterling, Joseph K Lim, Nancy Reau, Souvik Sarkar, David R Nelson, K R Reddy, Adrian M Di Bisceglie
BACKGROUND: New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. METHODS: PROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12weeks post-treatment (T4), 12months post-treatment (T5)...
June 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28289118/the-pcori-engagement-rubric-promising-practices-for-partnering-in-research
#19
Susan Sheridan, Suzanne Schrandt, Laura Forsythe, Tandrea S Hilliard, Kathryn A Paez
PURPOSE: Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric)...
March 2017: Annals of Family Medicine
https://www.readbyqxmd.com/read/28282340/readability-assessment-of-patient-centered-should-be-capitalized-entered-outcomes-research-institute-public-abstracts-in-relation-to-accessibility
#20
Jacqueline L Hollada, Mary Zide, William Speier, Debra L Roter
No abstract text is available yet for this article.
July 2017: Epidemiology
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