Evidence map›Paper›PMID 39505414›Full record

ReviewJournal of the American College of Cardiology2024

A Guide to Implementation Science for Phase 3 Clinical Trialists: Designing Trials for Evidence Uptake.

Harriette G C Van Spall, Laura Desveaux, Tracy Finch, Cara C Lewis, George A Mensah, Yves Rosenberg, Kavita Singh, Francois Venter, Bryan J Weiner, Faiez Zannad

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of the American College of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Harriette G C Van SpallFaculty of Health Sciences, Department of Medicine, McMaster University, and Population Health Research Institute, Hamilton, Ontario, Canada; Baim Institute for Clinical Research, Boston, Massachusetts, USA. Electronic address: Harriette.VanSpall@phri.ca.
Laura DesveauxInstitute for Better Health, Trillium Health Partners, Mississauga, Ontario, Canada.
Tracy FinchDepartment of Nursing, Midwifery and Health, Northumbria University, Newcastle-Upon-Tyne, United Kingdom; National Institute of Health Research (NIHR) North East and North Cumbria Applied Research Collaboration (NENC ARC), Newcastle-Upon-Tyne, United Kingdom.
Cara C LewisCenter for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
George A MensahCenter for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Yves RosenbergDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Kavita SinghPublic Health Foundation India, New Delhi, India; Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.
Francois VenterWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Public Health Medicine, School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.
Bryan J WeinerDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Faiez ZannadUniversité de Lorraine, Inserm Clinical Investigation Center at Institut Lorrain du Coeur et des Vaisseaux, University Hospital of Nancy, Nancy, France.

Funding

Intramural NIH HHS Z99 HL999999
6 · The paper itself

Abstract

The delayed and modest uptake of evidence-based treatments following cardiovascular clinical trials highlights the need for greater attention to implementation early in the development and testing of treatments. However, implementation science is not well understood and is often an afterthought following phase 3 trials. In this review, we describe the goals, frameworks, and methods of implementation science, along with common multilevel barriers and facilitators of implementation. We propose that some of the approaches used for implementation well after a trial has ended can be incorporated into the design of phase 3 trials to foster early post-trial implementation. Approaches include, but are not limited to, engaging broad stakeholders including patients, clinicians, and decision-makers in trial advisory boards; using less restrictive eligibility criteria that ensure both internal validity and generalizability; having trial protocols reviewed by regulators; integrating trial execution with the health care system; evaluating and addressing barriers and facilitators to deployment of the intervention; and undertaking cost-effectiveness and cost utility analyses across jurisdictions. We provide case examples to highlight concepts and to guide end-of-trial implementation.

Indexed as

Clinical Trials, Phase III as TopicImplementation ScienceEvidence-Based MedicineHumansResearch Designclinical trialsconceptual frameworksde-implementationimplementation sciencetrial design

Identifiers

PMID39505414
PMCPMC11723562

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.