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Title: WE-A-BRC-02: Lessons Learned: Clinical Trials and Operations

Abstract

Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandates recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand themore » impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803.« less

Authors:
 [1]
  1. Yale University (United States)
Publication Date:
OSTI Identifier:
22654087
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; CLINICAL TRIALS; LEARNING; PATIENTS; QUALITY ASSURANCE; RADIATION DOSES; RADIOTHERAPY; SAFETY

Citation Formats

Evans, S. WE-A-BRC-02: Lessons Learned: Clinical Trials and Operations. United States: N. p., 2016. Web. doi:10.1118/1.4957723.
Evans, S. WE-A-BRC-02: Lessons Learned: Clinical Trials and Operations. United States. doi:10.1118/1.4957723.
Evans, S. 2016. "WE-A-BRC-02: Lessons Learned: Clinical Trials and Operations". United States. doi:10.1118/1.4957723.
@article{osti_22654087,
title = {WE-A-BRC-02: Lessons Learned: Clinical Trials and Operations},
author = {Evans, S.},
abstractNote = {Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandates recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand the impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803.},
doi = {10.1118/1.4957723},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
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