What’s New in March for Vascular and Endovascular Surgery features: Clinical Trial Design and Statistics, Patient Safety in Surgical Care, Health Care Economics: The Broader Context

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Clinical Trial Design and Statistics

SAMANTHA M. THOMAS, MS
Department of Biostatistics & Bioinformatics, Duke Cancer Institute, Durham, NC

APRIL K.S. SALAMA, MD
Division of Medical Oncology, Duke University School of Medicine, Durham, NC

JULIE ANN SOSA, MD, MA, FACSbr />Endocrine Neoplasia Diseases Group, Duke Cancer Institute and Duke Clinical Research Institute, Durham, NC

 

Because of the complex nature of clinical trial design, significant resources and infrastructure are invested in drug development. Many drugs fail to progress beyond the phase I/II stage, and many phase III trials take years to accrue and publish results, leading to a delay in Food and Drug Administration (FDA) approval for diseases that desperately need better therapeutic options. The relatively recent FDA Safety and Innovation Act has allowed for the creation of priority and expedited review for drugs and biologics in serious conditions and where there is an unmet medical need. The designation of fast-track or breakthrough therapy may be granted when there is preclinical or clinical evidence to suggest that the intervention may result in a substantial improvement over currently available therapies.

 


 

Patient Safety in Surgical Care

Caprice C. Greenberg, MD, MPH, FACS
University of Wisconsin, Madison, WI

Amir Ghaferi, MD, MS, FACS
University of Michigan School of Medicine, Ann Arbor, MI

 

The same models and approaches to understanding surgical care delivery in the operating room translate well to the pre- and postsurgical care of patients where the events of the operating room may or may not influence the ultimate patient outcome… An analysis of 2,341 admissions to 10 hospitals in North Carolina evaluated temporal trends following publication of the 1999 Institute of Medicine report To Err Is Human: Building a Safer Health System and found that no difference was observed in the rates of patient harm between January 2002 and December 2007… There is strong evidence that poor teamwork and communication among health care providers are linked to poor outcomes and medical errors.

 


 

Health Care Economics: The Broader Context

LINDA G. LESKY, MD, MA
George Washington University, Washington, DC

ROBERT S. RHODES, MD, FACS
American Board of Surgery, Philadelphia, PA

CHARLES L. RICE, MD, FACS
Uniformed Services University of the Health Sciences Bethesda, MD

 

Surgeons should have a broad understanding of national health care spending. They can help restore confidence in the profession by helping to develop and then adhering to evidence-based approaches to surgical intervention.

 


As seen in Scientific AmericanTM Vascular and Endovascular Surgery.

 

Figure of the Month: The Figure of the Month for March is entitled Latent and Active System Failures Contribute to Injury. (Figure 1 from Patient Safety in Surgical Care).