Evaluation of the Implementation and Effectiveness of the American College of Surgeons Operative Standards Program

Project Summary For most solid tumors, high-quality surgery represents the greatest potential for cure. While many cancer quality improvement efforts have focused on screening and diagnostic processes or timely delivery of adjuvant therapies, relatively little attention has been paid to cancer surgery technical quality. To address this gap, the

American College of Surgeons (ACS) published 134 operative standards across 15 cancer types. Operative standards attempt to define critical elements of optimal cancer surgery that can be used as a quality assurance tool for practicing surgeons. The Commission on Cancer (CoC) recently implemented six of these standards

for accreditation, and hospitals are expected to reach 80% adherence by 2024. As the CoC accredits >1400 hospitals serving >70% of incident cancer patients, this program potentially impacts up to one million patients annually. There are several mechanisms by which operative standards may improve outcomes, but other

scenarios may lead to no effect or a false outcome signal. Operative standards could improve technical quality through behavioral mechanisms such as clinician education, the Hawthorne effect, or audit and feedback. Additionally, as many standards are directed at lymph node evaluations for cancer staging, standards may

improve staging and appropriate delivery of adjuvant therapies. On the other hand, operative standards may fail to improve cancer outcomes if they are directed at technical components already performed at high rates, at components not directly impacting outcomes, or if they target outcomes with low event rates. Finally, the

reporting of some standards will rely on self-assessment by the operating surgeon. In this case, operative standards may fail to improve outcomes if the surgeon incorrectly assesses the standards without a change in technical quality. Understanding whether the current slate of operative standards improves outcomes is critical.

Well-designed standards have the potential to reduce technical variation and improve quality. In contrast, ineffective standards would place costly and unnecessary administrative burdens on clinicians and CoC hospitals, potentially distract clinicians and hospitals from other high-quality care, or lead to more extensive

surgery that does not benefit patients. We propose to evaluate the impact of six CoC operative standards on short-term cancer outcomes by leveraging a natural experiment—the implementation timeline planned by the CoC, scheduled CoC site visits to assess for implementation of the standards, and pre-existing data collection

by the National Cancer Database (NCDB). To fully evaluate the relationship between the CoC operative standards and outcomes, we will employ a CoC Special Study to collect cancer recurrence outcomes not currently collected by NCDB. Further, we propose to evaluate implementation outcomes, including resource

burden across diverse CoC sites that potentially explain any observed heterogeneity in implementation or effect.