Marisha E. Palm
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View article: Community Engagement in Long Covid: Insights From the Boston COVID Recovery Cohort
Community Engagement in Long Covid: Insights From the Boston COVID Recovery Cohort Open
Background In 2021, the National Institutes of Health launched a multi‐centre observational study on long Covid: Researching COVID to Enhance Recovery (RECOVER). Six Boston academic medical centres joined community partners to become the B…
View article: Enhancing Translational Research Impact Through Collaborative Process Innovation
Enhancing Translational Research Impact Through Collaborative Process Innovation Open
View article: Enhancing Multicenter Trials With the Trial Innovation Network's Initial Consultation Process
Enhancing Multicenter Trials With the Trial Innovation Network's Initial Consultation Process Open
This qualitative study describes the Trial Innovation Network's initial consultation process, which provides researchers with resources and recommendations to address complex aspects of planning and conducting clinical trials.
View article: 127 Translational science must connect the dots from output to impact
127 Translational science must connect the dots from output to impact Open
Objectives/Goals: Despite efforts to support healthcare researchers to navigate translational gaps and achieve health impact, impact remains rare. We were interested in determining whether, when, and how researchers were taking actions to …
View article: The GIN-McMaster Guideline Development Checklist extension for engagement
The GIN-McMaster Guideline Development Checklist extension for engagement Open
View article: The Gin-Mcmaster Guideline Development Checklist (Gdc) Extension for Engagement
The Gin-Mcmaster Guideline Development Checklist (Gdc) Extension for Engagement Open
View article: Insights from the trial innovation network’s initial consultation process
Insights from the trial innovation network’s initial consultation process Open
Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Inst…
View article: Public involvement in UK health and care research 1995–2020: reflections from a witness seminar
Public involvement in UK health and care research 1995–2020: reflections from a witness seminar Open
Background Public involvement is important to the relevance and impact of health and care research, as well as supporting the democratisation of research. In 2020, the National Institute for Health Research (NIHR) reorganized and eliminate…
View article: 555 Design Lab Methodology Supports Innovation in Clinical Trials
555 Design Lab Methodology Supports Innovation in Clinical Trials Open
OBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handboo…
View article: 90 Novel approach for childhood Sjögren’s Disease therapies: multistakeholder design of a series of N-of-1 trials
90 Novel approach for childhood Sjögren’s Disease therapies: multistakeholder design of a series of N-of-1 trials Open
OBJECTIVES/GOALS: Childhood Sjögren’s disease (cSD) is a rare autoimmune disease. Despite the profound impact on children and their families, pediatric-specific clinical trials to inform therapeutic strategies in cSD are lacking. In 2022 w…
View article: Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials
Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials Open
Importance Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents…
View article: Key issues for stakeholder engagement in the development of health and healthcare guidelines
Key issues for stakeholder engagement in the development of health and healthcare guidelines Open
Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakehol…
View article: The Trial Innovation Network Liaison Team: building a national clinical and translational community of practice
The Trial Innovation Network Liaison Team: building a national clinical and translational community of practice Open
In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership …
View article: Development, implementation, and dissemination of operational innovations across the trial innovation network
Development, implementation, and dissemination of operational innovations across the trial innovation network Open
Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trial…
View article: Quantitative assessment of the impact of standard agreement templates on multisite clinical trial start up time
Quantitative assessment of the impact of standard agreement templates on multisite clinical trial start up time Open
Contracting delays remain a challenge to the successful initiation of multisite clinical research in the US. The Clinical and Translational Science Awards (CTSA) Contracts Processing Study showed average contract negotiation duration of > …
View article: The use of N-of-1 trials to generate real-world evidence for optimal treatment of individuals and populations
The use of N-of-1 trials to generate real-world evidence for optimal treatment of individuals and populations Open
Introduction: Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to…
View article: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network
Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network Open
One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative e…
View article: From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials
From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials Open
Background/Objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials. Methods: The n…
View article: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned
Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned Open
New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barri…
View article: Factors to Consider During Identification and Invitation of Individuals in a Multi-stakeholder Research Partnership
Factors to Consider During Identification and Invitation of Individuals in a Multi-stakeholder Research Partnership Open
Background Health research teams increasingly partner with stakeholders to produce research that is relevant, accessible, and widely used. Previous work has covered stakeholder group identification. Objective We aimed to develop factors fo…
View article: Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis Open
Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastr…
View article: A Useful and Sustainable Role for N‐of‐1 Trials in the Healthcare Ecosystem
A Useful and Sustainable Role for N‐of‐1 Trials in the Healthcare Ecosystem Open
Clinicians and patients often try a treatment for an initial period to inform longer‐term therapeutic decisions. A more rigorous approach involves N‐of‐1 trials. In these single‐patient crossover trials, typically conducted in patients wit…
View article: Financial Integration’s Impact On Care Delivery And Payment Reforms: A Survey Of Hospitals And Physician Practices
Financial Integration’s Impact On Care Delivery And Payment Reforms: A Survey Of Hospitals And Physician Practices Open
Health systems continue to grow in size. Financial integration-the ownership of hospitals or physician practices-often has anticompetitive effects that contribute to the higher prices for health care seen in the US. To determine whether th…
View article: Audio-/Videorecording Clinic Visits for Patient’s Personal Use in the United States: Cross-Sectional Survey
Audio-/Videorecording Clinic Visits for Patient’s Personal Use in the United States: Cross-Sectional Survey Open
Policy guidance from health systems and further examination of the impact of recordings-positive or negative-on care delivery, clinician-related outcomes, and patients' behavioral and health-related outcomes is urgently required.
View article: Audio-/Videorecording Clinic Visits for Patient�s Personal Use in the United States: Cross-Sectional Survey (Preprint)
Audio-/Videorecording Clinic Visits for Patient�s Personal Use in the United States: Cross-Sectional Survey (Preprint) Open
BACKGROUND Few clinics in the United States routinely offer patients audio or video recordings of their clinic visits. While interest in this practice has increased, to date, there are no data on the prevalence of recording clinic visits …