Editorial Material
Health Care Sciences & Services
Jose A. Sacristan, J. Andre Knottnerus
Summary: Although Evidence-based medicine (EBM) and Patient-centered medicine (PCM) are often seen as conflicting paradigms, they both aim to improve the care of individual patients. A new research method oriented towards individual patients has been proposed, incorporating patients' preferences into personalized research protocols within clinical trials.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Review
Medicine, General & Internal
Jinwoong Lim, Hyeonhoon Lee, Yong-Suk Kim
Summary: This study aims to investigate the pragmatism of pragmatic acupuncture trials through the application of the PRECIS-2 tool. The method includes searching for published self-declared 'pragmatic' RCTs or protocols and conducting reviews. The study will assess the pragmatism using nine domains of the PRECIS-2 tool and one additional control domain, with results presented through descriptive statistics and wheel diagrams.
Article
Medicine, General & Internal
Cheow Peng Ooi, Abdul Hanif Khan Yusof Khan, Rosliza Abdul Manaf, Norlaila Mustafa, Norlela Sukor, Paula R. Williamson, Nor Azmi Kamaruddin
Summary: Thyroid dysfunctions (TD) are common medical conditions affecting global populations. This project aims to develop a core outcome set (COS) for adult patients with TD, embedding multiple complex dimensions of routine clinical care. By using a mixed-method approach in two phases, including qualitative research and systematic reviews, the study will identify and categorize outcomes to reach a consensus through an online Delphi exercise involving key stakeholders.
Review
Oncology
Bernard Bright Davies-Teye, Michelle Medeiros, Cynthia Chauhan, Claudia Rose Baquet, C. Daniel Mullins
Summary: Oncology trials are increasingly focusing on pragmatism and meaningful patient engagement. This study offers practical guidance on how to achieve both goals, leading to increased participation, faster recruitment, better retention, and adoption of innovative technologies in community-based care.
Review
Medicine, General & Internal
Heather Barrington, Bridget Young, Paula R. Williamson
Summary: Variability was found in the design and conduct of COS studies that included patients, with differences in scoring systems, recruitment approaches, time between rounds, use of reminders, incentives, patient involvement, and piloting. Studies recruiting patients through treatment centers had higher response rates in round two. Further research is needed to explore patient motivation in COS studies and factors influencing recruitment strategies.
Article
Geriatrics & Gerontology
Cari Levy, Sheryl Zimmerman, Vincent Mor, David Gifford, Sherry A. Greenberg, Juliet Holt Klinger, Cathy Lieblich, Sunny Linnebur, Angie McAllister, Arif Nazir, Douglas Pace, Robyn Stone, Barbara Resnick, Philip D. Sloane, Joseph Ouslander, Joseph E. Gaugler
Summary: This article discusses the importance of pragmatic trials in improving the dissemination and implementation of evidence-based care interventions in long-term care. Experts provided key principles and recommendations related to implementation and dissemination, highlighting the need to engage stakeholders, ensure diversity and inclusion, assess organizational readiness, learn from adaptations, integrate interventions into existing workflows, maintain agility and responsiveness, package the message for the audience, engage diverse audiences, and apply dissemination and diffusion tools. The implementation processes should be grounded in the perspectives of those responsible for implementing the intervention, and messaging should speak to long-term care staff and other stakeholders.
Review
Medical Laboratory Technology
Tim Hulsen, David Friedecky, Harald Renz, Els Melis, Pieter Vermeersch, Pilar Fernandez-Calle
Summary: Among medical specialties, laboratory medicine plays a crucial role in implementing big data and artificial intelligence in healthcare. The integration of all clinical data sets is important for patient-centered treatment. Challenges in data-driven research can be addressed using the FAIR Guiding Principles, federated learning, standards, and ontologies. Big data and artificial intelligence offer opportunities for laboratories to optimize productivity and improve patient outcomes.
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
(2023)
Article
Geriatrics & Gerontology
Barbara Resnick, Sheryl Zimmerman, Joseph Gaugler, Joseph Ouslander, Kathleen Abrahamson, Nicole Brandt, Cathleen Colon-Emeric, Elizabeth Galik, Stefan Gravenstein, Lona Mody, Philip D. Sloane, Kathleen Unroe, Hilde Verbeek
Summary: This article introduces pragmatic trials as a research method to generate results applicable to real-world care. It discusses the challenges and solutions of conducting pragmatic trials in long-term care, focusing on three clinical areas and provides recommendations for future research in this field.
JOURNAL OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION
(2022)
Article
Geriatrics & Gerontology
Jennifer Gabbard, Tina R. Sadarangani, Rupak Datta, Chanee D. Fabius, Cameron J. Gettel, Natalie F. Douglas, Lisa A. Juckett, Andrew M. Kiselica, Komal Patel Murali, Ellen P. McCarthy, Alexia M. Torke, Christopher M. Callahan
Summary: The lack of infrastructure to support a coordinated clinical response for people living with dementia (PLWD) and the shortage of researchers conducting rigorous embedded pragmatic clinical trials (ePCTs) are hindering the delivery of high quality dementia care. The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's disease and Related Dementias Clinical Trials (IMPACT) Collaboratory aims to address these challenges by funding career development awards and providing training opportunities and support networks. This report discusses the career development challenges faced by early-career researchers involved in ePCTs for dementia care and offers concrete suggestions to address these challenges.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
(2023)
Review
Health Care Sciences & Services
Joan G. Carpenter, Connie Ulrich, Nancy Hodgson, Laura C. Hanson, Mary Ersek
Summary: Palliative care research faces ethical challenges in obtaining informed consent, prompting the exploration of alternative approaches to traditional consent methods. By innovating consent models, researchers aim to enhance recruitment, enrollment, and retention in clinical trials focused on palliative care. Further research is needed to evaluate the impact of these differing consent models on participants' understanding and engagement in research.
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT
(2021)
Article
Geriatrics & Gerontology
Barbara Resnick, Sheryl Zimmerman, Joseph Gaugler, Joseph Ouslander, Kathleen Abrahamson, Nicole Brandt, Cathleen Colon-Emeric, Elizabeth Galik, Stefan Gravenstein, Lona Mody, Philip D. Sloane, Kathleen Unroe, Hilde Verbeek
Summary: This article presents key points raised by experts at a conference funded by the National Institute of Aging, discussing the special considerations and challenges of pragmatic trials in long-term care. The focus is on functional care and outcomes, psychosocial care and quality of life, and medical care and outcomes, with a special emphasis on individuals with dementia.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
(2022)
Review
Gastroenterology & Hepatology
Elliot B. Tapper, Marina Serper, David S. Goldberg
Summary: Patients with chronic liver disease can benefit from pragmatic trial designs, which aim to provide evidence for the adoption of interventions in real-world clinical practice. The efficiency of identifying, recruiting, and following patients, the resemblance of interventions and design to usual clinical care, and the importance of outcomes to patients are key factors in determining the pragmatism of a trial. This review focuses on the promise, trade-offs, and purpose of pragmatic trials in hepatology.
Article
Medicine, General & Internal
Mahrukh Imran, Linda Kwakkenbos, Stephen J. McCall, Kimberly A. McCord, Ole Frobert, Lars G. Hemkens, Merrick Zwarenstein, Clare Relton, Danielle B. Rice, Sinead M. Langan, Eric Benchimol, Lehana Thabane, Marion K. Campbell, Margaret Sampson, David Erlinge, Helena M. Verkooijen, David Moher, Isabelle Boutron, Philippe Ravaud, Jon Nicholl, Rudolf Uher, Maureen Sauve, John Fletcher, David Torgerson, Chris Gale, Edmund Juszczak, Brett D. Thombs
Summary: The development of CONSORT-ROUTINE involved a scoping review, a Delphi study, a consensus meeting, and publication. The final checklist includes new and modified items, aiming to improve the reporting quality of trials conducted using cohorts and routinely collected data.
Article
Medicine, General & Internal
Jennifer Le-Rademacher, Heather Gunn, Xiaoxi Yao, Daniel J. Schaid
Summary: Clinical trials are important for evaluating the safety and efficacy of new interventions. Traditional explanatory trials focus on exploring the biological causes and effects, while pragmatic trials consider real-world conditions and aim to optimize interventions in diverse clinical practices. It is essential to maintain scientific rigor, increase trial efficiency, ensure generalizability of results, and address health disparities through technology and decentralized approaches.
MAYO CLINIC PROCEEDINGS
(2023)
Article
Geriatrics & Gerontology
Cari Levy, Sheryl Zimmerman, Vincent Mor, David Gifford, Sherry A. Greenberg, Juliet Holt Klinger, Cathy Lieblich, Sunny Linnebur, Angie McAllister, Arif Nazir, Douglas Pace, Robyn Stone, Barbara Resnick, Philip D. Sloane, Joseph Ouslander, Joseph E. Gaugler
Summary: Randomized controlled trials are considered rigorous research designs, but face challenges in real-world settings. Pragmatic trials are viewed as a design that overcomes these challenges. Long-term care researchers and providers need to consider stakeholder engagement, diversity and inclusion, organizational strain and readiness, and learning from adaptations in the implementation of pragmatic trial interventions.
JOURNAL OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION
(2022)