Evolution of the American College of Cardiology/American Heart Association Clinical Guidelines

Han, Henry; Chao, Howard; Guerra, Andres; Sosa, Alan; Christopoulos, Georgios; Christakopoulos, Georgios E.; Rangan, Bavana V.; Maragkoudakis, Spyros; Jneid, Hani; Banerjee, Subhash; Brilakis, Emmanouil S.

doi:10.1016/j.jacc.2015.04.050

Cited by 25 publications

(11 citation statements)

References 30 publications

(6 reference statements)

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“…High-quality evidence regarding the risks and benefits of treatments is lacking across a multitude of clinical specialties [ 1 – 7 ], and the clinical research enterprise is not focused on generating the kind of information that drives national guidelines for clinical care. Similarly, traditional clinical trials are often unable to provide high quality evidence in a timely or cost-effective manner [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Weinfurt

Hernandez

Coronado

et al. 2017

BMC Med Res Methodol

141

118

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BackgroundThe clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.MethodsTo strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.ResultsIn this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.ConclusionA planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

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Section: Introductionmentioning

confidence: 99%

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Weinfurt

Hernandez

Coronado

et al. 2017

BMC Med Res Methodol

141

118

View full text Add to dashboard Cite

show abstract

“…This is not the first time such observations have been made. Only 15 % of American cardiology guidelines were based on high quality studies (19). Judgement and subjective evaluations based on personal and/or organisational preferences are used when deciding which studies to include in the evidence base and how they should be weighted (20).…”

Section: Discussionmentioning

confidence: 99%

Coronary angiography in non-ST-elevation acute myocardial infarction – whom and when?

Bønaa¹,

Steigen²

2017

Tidsskriftet

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“…Although randomized controlled clinical trials are the gold standard for determining the efficacy and safety of an intervention, only 15% of the American College of Cardiology/American Heart Association guideline recommendations are based on level A evidence 11. Therefore, in most cases, clinical decision making relies on less robust clinical evidence, such as retrospective and observational studies.…”

Section: Clinical Benefitsmentioning

confidence: 99%

Chronic Total Occlusion Percutaneous Coronary Intervention: Evidence and Controversies

Tajti

Brilakis

2018

JAHA

Self Cite

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Evolution of the American College of Cardiology/American Heart Association Clinical Guidelines

Abstract: The ACC/AHA guideline recommendations are undergoing significant changes, becoming more evidence based and scientifically robust with a tendency to exclude recommendations with insufficient scientific evidence.

Cited by 25 publications

References 30 publications

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Coronary angiography in non-ST-elevation acute myocardial infarction – whom and when?

Chronic Total Occlusion Percutaneous Coronary Intervention: Evidence and Controversies

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