CoC Operative Standards Address Variations in Surgical Technical Quality

For most patients with cancer, high-quality surgery represents their best chance of a cure. In 2023, more than 2 million people in the US were diagnosed with cancer, 60% of whom underwent surgery to treat or stage their disease.¹

High-quality cancer surgery comprises primary surgical resection aimed at achieving negative surgical margins and accurate lymph node staging, which informs subsequent treatment decisions. Effective primary surgical resection and lymph node staging lead to better oncologic outcomes through the combination of improved local cancer control and access to critical information to guide administration of appropriate adjuvant systemic and radiation therapy as indicated. 

Differences in disease-specific and overall survival across hospitals have been observed for patients with many cancer types. While a significant amount of cancer care delivery research has been conducted, it primarily has focused on diagnostic and staging processes and adherence to adjuvant therapy guidelines. 

The inherent difficulties in measuring and reporting surgical technical quality—how well a surgeon performs an operation—have left the impact of variations in technical quality on patient outcomes largely understudied.

Targeting Variations in Surgical Technical Quality

To help decrease variations in surgical technical quality, the ACS recently published the Operative Standards for Cancer Surgery manuals.² The 134 published operative standards provide foundational, evidence-based recommendations on cancer surgery to help practicing surgeons perform high-quality operations with the goal of improving patient outcomes such as cancer-specific survival and quality of life.

The ACS Commission on Cancer (CoC), which accredits approximately 1,400 US cancer programs that collectively treat 74% of all incident cancer patients, implemented six of these operative standards in 2020 as part of its national accreditation process.³ The current CoC operative standards target both primary surgical resection and lymph node staging and apply to five cancer types: breast, melanoma, colon, rectum, and lung.

Evaluating Compliance and Impact on Cancer Outcomes

Patient-level compliance with the operative standards must be documented in operative or pathology reports that include specific responses in synoptic format. CoC sites are evaluated for compliance during their accreditation site visits. For each of the standards, CoC site reviewers randomly select seven eligible operative cases to assess compliance. As of 2023, all CoC-accredited hospitals are expected to be at least 80% compliant with each standard.

The implementation of the CoC operative standards represents an unprecedented attempt to standardize surgical technical quality. Given the extensive reach of the CoC, this initiative has the potential to affect the care of millions of patients, influence the practices of thousands of surgeons, and shape major institutional investments in quality improvement. Although retrospective data suggest an association between operative standards and cancer outcomes, a causal link has yet to be established.^4,5 Therefore, understanding whether implementation of the CoC operative standards directly improves oncologic outcomes is essential for guiding surgical cancer quality initiatives.

Study Evaluates Implementation of CoC Operative Standards

The National Cancer Institute (NCI) awarded grant funding to support the Assessing the Effectiveness and Significance of the Operative Standards Program (AESOP) study (R01 CA288625), led by co-principal investigators Lesly A. Dossett, MD, MPH, FACS, from the University of Michigan in Ann Arbor, and Daniel J. Boffa, MD, MBA, FACS, from the Yale School of Medicine in New Haven, Connecticut. Drs. Dossett and Boffa are joined by co-investigators Ronald Weigel, MD, PhD, MBA, FACS, Medical Director of the ACS Cancer Programs, and Judy C. Boughey, MD, FACS, Chair of the ACS Cancer Research Program.

In collaboration with the ACS, this 5-year study leverages the CoC’s national implementation of the operative standards across a range of cancer programs to evaluate whether these standards can be widely adopted and whether they improve short-term cancer outcomes. 

The study’s first aim is to assess the implementation of the CoC operative standards across cancer and hospital types using data collected during CoC site visits. The primary outcome is the overall compliance rate with the six CoC operative standards. Additionally, the study will identify associations between compliance and facility characteristics, including hospital size, surgical volume, and cancer program type.

The study also focuses on identifying barriers and facilitators to the implementation of the CoC operative standards, which will help explain any variability in compliance rates observed across facilities. Another aim of the study is to evaluate how the CoC operative standards impact short-term cancer outcomes. The study will perform a CoC Special Study to abstract key data elements not currently collected by the National Cancer Database (e.g., cancer recurrence) to determine whether the CoC operative standards improve cancer care.

Early Insights from AESOP Study

The AESOP study team has begun analyzing early compliance data for CoC Standard 5.7 on total mesorectal excision for rectal cancer and CoC Standard 5.8 on mediastinal lymph node sampling for lung cancer.

Data from CoC site visits conducted in 2022 and 2023 show that among nearly 500 eligible CoC sites, 88% were compliant with Standard 5.7 for rectal cancer. Furthermore, most noncompliant hospitals were close to achieving compliance, often needing just one or two additional compliant cases. However, early compliance data for CoC Standard 5.8 in lung cancer reveal more room for improvement, with about half of the sites being noncompliant. These results underscore the importance of the growing efforts of the ACS to provide hospitals and surgeons with quality improvement tools and resources for CoC Standard 5.8.

In addition to assessing compliance with the CoC operative standards, the AESOP study team has sought to understand the perspectives of CoC site reviewers. Interviews with current site reviewers reveal their perceived roles as advocates, educators, and partners to the programs they visit. Future implementation strategies may leverage the relationships between CoC site reviewers and the sites to help improve compliance rates.

The CoC operative standards present a novel opportunity to improve cancer care by addressing variations in surgical technical quality. As we venture into uncharted territory, it will be important to study how these standards are implemented across different cancer types and hospital settings, and whether cancer outcomes are impacted.

The AESOP study will deliver critical insights on both fronts. Its findings will guide revisions to the operative standards and enhance implementation strategies across a range of cancer programs.  Moreover, if the CoC operative standards demonstrate an improvement in cancer outcomes, this study will provide compelling rationale for expanding these standards to additional surgical procedures, both within and beyond cancer care.

Dr. Alison Baskin is a general surgery resident at the University of California San Francisco, NCI Research Fellow in Cancer Care Delivery (T32 CA2366215), and ACS Designated Scholar. She is the current postdoctoral research fellow for the AESOP study.

References

1. Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48.
2. Nelson HD, Hunt KK, Oncology AfCTi. Operative Standards for Cancer Surgery. Philadelphia, PA: Lippincott Williams & Wilkins; 2015.
3. Katz MHG, Francescatti AB, Hunt KK. Cancer Surgery Standards Program of the American College of Surgeons. Technical Standards for Cancer Surgery: Commission on Cancer standards 5.3-5.8. Ann Surg Oncol 2022;29(11):6549-6558.
4. Zhao B, Tsai C, Hunt KK, Blair SL. Adherence to surgical and oncologic standards improves survival in breast cancer patients. J Surg Oncol. 2019;120(2):148-159.
5. Kitz J, Fokas E, Beissbarth T, et al. Association of plane of total mesorectal excision With prognosis of rectal cancer: Secondary analysis of the CAO/ARO/AIO-04 phase 3 randomized clinical trial. JAMA Surg. 2018;153(8):e181607.