Methodological Standards for the Design, Implementation, and Analysis of Randomized Trials in Cardiac Surgery: A Scientific Statement From the American Heart Association

Cardiac surgery presents specific methodological challenges in the design, implementation, and analysis of randomized controlled trials. The purposes of this scientific statement are to review key standards in cardiac surgery randomized trial design and implementation, and to provide recommendations for conducting and interpreting cardiac surgery trials. Recommendations include a careful evaluation of the suitability of the research question for a clinical trial, assessment of clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the safety and efficacy of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and appropriate strategies must be used to ensure adequate deliverability of the trial interventions. Every effort must be made to ensure a high completeness of follow-up; trial design and analytic techniques must be tailored to the specific research question and trial setting.

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Evaluation and follow-up of pediatric COVID-19 in terms of cardiac involvement: A Scientific Statement from the Association of Turkish Pediatric Cardiology & Pediatric Cardiac Surgery

The Anatolian Journal of Cardiology ◽

10.14744/anatoljcardiol.2020.36559 ◽

2020 ◽

Cited By ~ 1

Author(s):

Gülendam Koçak

Keyword(s):

Cardiac Surgery ◽

Cardiac Involvement ◽

Pediatric Cardiology ◽

Pediatric Cardiac Surgery ◽

Scientific Statement

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Early Palliative Care for Patients with Metastatic Non-Small Cell Lung Cancer (DRAFT)

10.1093/med/9780190658618.003.0001 ◽

2018 ◽

Author(s):

Nathan A. Gray ◽

Thomas W. LeBlanc

Keyword(s):

Lung Cancer ◽

Palliative Care ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Trial Design ◽

Small Cell ◽

Small Cell Lung ◽

Early Palliative Care ◽

Study Intervention

This chapter provides an overview and commentary on the 2010 study by Temel and colleagues regarding early palliative care for patients with non-small cell lung cancer. It describes the trial design and findings while also providing a concise critique of the study and a brief review of relevant subsequent studies. The chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case.

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Considerations for Reduction of Risk of Perioperative Stroke in Adult Patients Undergoing Cardiac and Thoracic Aortic Operations: A Scientific Statement From the American Heart Association

Circulation ◽

10.1161/cir.0000000000000885 ◽

2020 ◽

Vol 142 (14) ◽

Cited By ~ 1

Author(s):

Mario Gaudino ◽

Curtis Benesch ◽

Faisal Bakaeen ◽

Abe DeAnda ◽

Stephen E. Fremes ◽

...

Keyword(s):

Cardiac Surgery ◽

American Heart Association ◽

American Heart ◽

Heart Association ◽

Diagnosis And Treatment ◽

Perioperative Stroke ◽

Neurological Risk ◽

Prediction And Prevention ◽

Scientific Statement ◽

Timing Of Onset

Perioperative stroke is one of the most severe and feared complications of cardiac surgery. Based on the timing of onset and detection, perioperative stroke can be classified as intraoperative or postoperative. The pathogenesis of perioperative stroke is multifactorial, which makes prediction and prevention challenging. However, information on its incidence, mechanisms, diagnosis, and treatment can be helpful in minimizing the perioperative neurological risk for individual patients. We herein provide suggestions on preoperative, intraoperative, and postoperative strategies aimed at reducing the risk of perioperative stroke and at improving the outcomes of patients who experience a perioperative stroke.

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Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence

10.1093/med/9780190625085.003.0049 ◽

2018 ◽

Author(s):

Kevin Johnson ◽

Srinivas Muvvala

Keyword(s):

Alcohol Dependence ◽

Behavioral Interventions ◽

Alcohol Use Disorder ◽

Clinical Case ◽

Research Question ◽

Heavy Alcohol Consumption ◽

Behavioral Therapies ◽

Study Intervention ◽

Landmark Study

This chapter provides a summary of the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence Study. This landmark study researches the efficacy of medications, behavioral therapies, and their combinations in the treatment of alcohol use disorder. Starting with the research question, this review describes the basics of the study, including funding, study location, who was studied, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. One key finding is the efficacy of naltrexone at lowering the number of heavy alcohol consumption days. The chapter briefly reviews other relevant studies and information, discusses implications, provides clinical guidelines, and concludes with a relevant clinical case.

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Abstract W P263: Rapidly Resolving Symptoms..Stop the Race! No Symptoms, No Alteplase!

Stroke ◽

10.1161/str.45.suppl_1.wp263 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Shannon L Smith ◽

Mark C Schultz

Keyword(s):

Ischemic Stroke ◽

Clinical Symptoms ◽

Research Question ◽

Heart Association ◽

Home Health ◽

Joint Commission ◽

Poor Outcomes ◽

Negative Imaging ◽

The Joint Commission

Background: Research has shown that one-third of patients not treated with thrombolytic therapy due to minor or rapidly improving symptoms have poor outcomes that are considered disabling. The purpose of this study was to determine if opportunities were missed to treat with Alteplase. Research Question: What is the outcome of patients arriving to the emergency room with symptoms of an ischemic stroke not treated with Alteplase because of rapidly improving symptoms? Method: A retrospective analysis of patients between January 2012 and February 2013 with ischemic stroke or TIA, whose ICD-9 coding at discharge is in alignment with the Joint Commission and the American Heart Association. STK 4 from the Joint Commission was used to define the population. Patients with documentation from the physician stating that no Alteplase was given due to rapidly resolving symptoms were included. Magnetic resonance imaging and National Institute of Health scores were used along with clinical symptoms to diagnose potential stroke. Results: Of 47 patients reviewed, 34% had positive imaging and were coded with an ischemic stroke code and 66% had negative imaging and were coded with a transient ischemic attack code. Of the 34% with positive imaging, 38% were discharged to home with home health for therapy follow-up. Of the 66% with negative imaging, 19% were discharged home with home health for therapy follow-up. Of the 47 patients, 6% had a National Institute of Health stroke scale score of 1-3 with positive imaging and 4% had a score of 4 or greater with positive imaging.13% had a score of 0 on admit and 0 on discharge with positive imaging. Conclusion: We found a third of patients who did not receive Alteplase due to rapidly resolving symptoms did have a stroke and several required therapy services after discharge for residual deficits that were potentially disabling. In addition, the National Institute of Health Stroke Scale was not consistently beneficial in diagnosing acute stroke for patients with normal or low scores who were ultimately diagnosed with stroke.

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