In Reply.—We thank the authors of the letter to the editor on our recent editorial publication “Exploring the College of American Pathologists Electronic Cancer Checklists”1  for their interest in our work and their helpful comments, along with continuing to promote the discussion about synoptic reporting. As the College of American Pathologists (CAP) Pathology Electronic Reporting (PERT) Committee, we are committed to maintaining and helping guide development of the CAP electronic cancer checklists (eCC). We have made it a priority to publicize our processes to increase transparency to our members and colleagues about eCC development, and to welcome those who wish to make contributions. Building on this introductory editorial, we plan to publish a series of articles that will include more detailed exploration of our experience with protocol development, including supporting software tools that we have developed, approaches to past and future standardization challenges, and engagement of important stakeholders including the vendor community.

The authors of the accompanying letter present an opening question: “…what exactly can the eCC do for me?” We prefer to expand the scope to include cancer patients and the cancer control community. The use of nationally standardized and centrally managed data elements facilitate not only patient care but also interdisciplinary work across the larger stakeholder community. Indeed, in that broader context our stakeholders include our pathology community, the American Joint Committee on Cancer, the Centers for Disease Control and Prevention, the National Cancer Institute, the World Health Organization, the American Society of Clinical Oncology, the North American Association of Central Cancer Registries, the American College of Surgeons, and our laboratory information system (LIS) vendors. Since this introductory article was published, we published additional articles focused on the value of the eCC.2,3  These publications addressed interoperability, particularly in the context of downstream, secondary use of the discretized, standardized data in the eCC. These papers were specifically targeted to our clinical colleagues to promote understanding not only of the protocols and standardized structured reporting in general, but also their roles in data exchange, the improvement of patient care, and future directions with respect to downstream use of the data. The eCC data model will become increasingly important as the 21st Century Cures Act4  and many related rules anticipated from the Center for Medicare and Medicaid Services are implemented. The use of eCC data will allow the CAP to support pathologists with standardized, centralized solutions and to provide implementation assistance to meet these governmental mandates while lowering the burden on pathologists. We hope that these publications, along with our future publications, will promote better understanding of the value of the CAP Cancer Protocols and corresponding eCC, as well as reinforce the central role of our pathology specialty within the future of healthcare informatics.

The authors point out some of the complexities innate to our relationships with the anatomic pathology LIS vendors that implement the electronic cancer protocols. Indeed, vendors are not required to implement any of the ergonomic features outlined in our article, in particular those that may require additional investment. However, vendors are also sensitive to customer needs and demands as systems evolve. Furthermore, the purpose of discussing expected vendor functionality in our article was particularly to encourage the pathology user community to directly question their vendor as to why they cannot perform specific functions described by the CAP. A full discussion of the challenges inherent to the vendor implementation process was outside the scope of our introductory article. Subsequent publications will expand upon successes and challenges in this realm. These will include descriptions of our direct LIS vendor engagement project via the Vendor Implementation Collaboration program, which has already yielded excellent progress toward building symbiotic relationships between CAP and the LIS vendors grounded in knowledge sharing, a deeper understanding of implementation methods, the relevant barriers to full implementation, and ways in which we can work together to improve the final products used in pathologists' daily workflow. The vendors are also surveyed regularly with respect to the functionality currently available on a vendor basis. Individual vendors can see their responses (deidentified) compared with their “peers.” This has been well received in the industry and we have already started to see major advancements in eCC functionality being offered.

Another item specifically mentioned in the letter to the editor was the utilization of nonnumeric operators in the acquisition of numeric data, such as “at least” or “greater than” in the context of an argument against requiring input validation of numeric values. Indeed, we do include a choice to use a number of these operators in the context of collecting a numeric value, which we validate as a numeric response to facilitate its downstream reuse as a number value. Without this specification, some of the analytics applied to the numerical data would fail. With the understanding that an exact number or even a minimum or maximum value might not be attainable, we routinely include an option to indicate that such a value cannot be reported with a free-text field to explain. Our goal is to encourage the community to use interoperable values as much as possible, but we do understand the need for flexibility for special cases.

The letter to the editor also mentioned the development and maintenance of web-based synoptic reporting or traditional “canned text” synoptic free-text forms as alternative reporting options that are certainly valid. In fact, there are several “alternatives” to the CAP eCC and the purpose of the article was not intended to be promotional. Rather, it was meant to clearly state the benefits of discretized data and the need for our peers to help push their vendors to provide the best solutions possible. We note that members of the involved CAP committees have previously implemented their own web-based solution5  and subsequently used vendor-implemented eCC. They have commented that the in-house web-based solution is more difficult to maintain and update as new protocol versions are released. In addition, important considerations for adopting such tools are interoperability across electronic health care systems and exchange and reuse of the data by stakeholders, such as disease registries, along with data access control and adherence to federal regulations concerning protected health information. We outline and illustrate in our publications the importance of downstream interoperabilty and electronic reuse of the data that is best achieved via integrated electronic synoptic reporting systems based in a common standardized language and format.

The authors also mention several other features that could benefit pathologists that were not addressed in our publication. We agree with the authors on the value of implementing immunohistochemical support and ancillary testing to the diagnostic output rendered by an electronic diagnostic cancer checklist. Although not explicitly mentioned in our introductory publication, biomarker templates are available and integral parts of the CAP Cancer Protocols and available to be implemented in the LIS workflow, although not required for accreditation. It is the purpose of these templates to use structured data capture to limit the use of custom questions in favor of validated data standards using metadata that can be stored in a data repository to facilitate data interoperability and reuse.

Last, software and field validation is an integral part of the CAP PERT Committee workflow before the publication of electronic cancer checklists. This validation process will be more specifically addressed in a future publication focused on the informatics infrastructure that supports the development of the CAP eCC.

The development of data element content (Word and PDF versions) and electronic implementation of the eCC is overseen by 2 CAP committees (Cancer Committee and PERT) and CAP staff. Feedback from our users is integral to accomplishing these goals and creating the best product available to help direct patient care. We thank the authors for their letter to the editor. Comments or questions on the protocols in electronic or paper version can be emailed to the committee at cprotoc@cap.org.

The authors graciously thank Sabrina Krejci, Kim Durham, Eric Daley, Keren Hulkower, PhD, Richard Moldwin, MD, PhD, and Samantha Spencer, MD, for all the assistance and support provided to the PERT Committee and with this correspondence.

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