Checklists, Protocols, and the “Gold Standard” Approach

Abstract

Checklists (now referred to as case summaries) have been used for educational and quality improvement purposes in surgical pathology reporting of cancer cases for a number of years, with published protocols, checklists, and structured reports developed by many societies such as the Association of Directors of Anatomic and Surgical Pathology, the College of American Pathologists (CAP), and The Royal College of Pathologists of the United Kingdom. The adoption of checklists designed to improve the quality of patient care is also gaining momentum in various clinical settings, including perioperative suites, emergency departments, and intensive care units.1,2 In pathology, the use of checklists or structured reporting for histopathologic findings in cancer resection cases has been shown to produce sustained improvement in reporting of critical data elements.3 However, development, maintenance, dissemination, and revision of such checklists can be labor intensive and costly because the documents must be continuously reviewed and updated as medical knowledge and practices change. This review process is especially important when adherence to pathology reporting protocols is included as a standard for accreditation, as by the Commission on Cancer of the American College of Surgeons in the accreditation of cancer programs.The “Protocol for the Examination of Specimens From Patients With Pheochromocytomas and Extra-adrenal Paragangliomas,”4 published in this issue of the Archives of Pathology and Laboratory Medicine, represents a “gold standard” approach to reporting of these rare neoplasms based on expert opinion from a distinguished international group of pathologists and endocrinologists. However, it is not an official protocol of the CAP. The CAP cancer protocols are developed by the CAP Cancer Committee and multidisciplinary Cancer Protocol Review Panels, which include pathologists from various practice settings (academics, community practice, and large reference laboratories), surgeons, and medical and radiation oncologists. Protocols undergo a stringent review process that includes posting for public comment, followed by review of all comments by the CAP Cancer Committee, with final revisions to the protocol made in response to this feedback.New cancer protocols officially endorsed by the CAP are developed in response to needs from the larger oncology community. Because the protocol portfolio has matured over the years since the publication of the first CAP cancer checklists in 19865, new protocols are often developed in response to changes in the American Joint Committee on Cancer TNM staging manual. For example, at the time of this writing a new CAP cancer protocol for uterine sarcomas is in the final stages of development in response to a separate staging schema for this tumor type as adopted by the Féderation Internationale de Gynécologie et d'Obstétrique and by the American Joint Committee on Cancer in the 7th edition of the AJCC Cancer Staging Manual.6As an integral part of the protocol development process, each required data element in new CAP cancer protocols undergoes analysis for the level of evidence supporting its inclusion in the protocol.7 This rigorous review step is designed to avoid required reporting of data elements for which insufficient data exist to support reporting in every case of that tumor type. Restricting required data elements to widely accepted prognostic factors and those needed to support patient care and treatment decisions reduces the burden of report generation by practicing pathologists, while still providing complete information for oncologists and supporting tumor registries. Data elements in existing CAP cancer protocols are undergoing the same scrutiny for supporting evidence as part of the International Collaboration on Cancer Reporting. This international initiative seeks to harmonize existing cancer reporting protocols developed by organizations such as the CAP and the Royal College of Pathologists of the United Kingdom and of Australasia, with the goal of developing a globally relevant minimum data set for each cancer type. Each founding organization has committed to include the required elements in its locally developed protocols, to facilitate comparison of cancer cases on a worldwide basis, and to reduce the burden of cancer data set development and maintenance. This harmonization process with review of levels of evidence, as applied to 4 data sets produced by the International Collaboration on Cancer Reporting (lung,8 prostate,9 endometrium,10 and melanoma [in preparation]), resulted in a reduced number of required elements for each site because of the elimination of some traditionally reported pathology elements that were not supported by available medical literature as having an effect on patient care or outcome. While the pheochromocytoma protocol published in this issue is an excellent educational document, many of the data elements are based primarily on expert opinion and evidence obtained from small case series, and some data (such as the histologic growth pattern) may be difficult for nonspecialist pathologists to evaluate in a reproducible manner.Although proposals for new protocols have traditionally originated within the CAP Cancer Committee, the interest in checklist development by other groups has prompted the consideration of ways to solicit proposals from CAP Cancer Committee nonmembers, similar to the process for clinical trial development within cooperative groups. Accordingly, the CAP is developing a process for soliciting proposals for new checklists early in the developmental stage for groups that may want to seek the adoption of such checklists as official CAP cancer protocols. Early review of proposals by the CAP Cancer Committee would allow such protocols to be developed using a multidisciplinary, multitiered iterative approach, including the assessment of levels of evidence for required data elements. Careful review of draft protocols by pathologists practicing outside of academic institutions also provides feedback on the feasibility of inclusion of some data elements that may be subject to wide variations in interpretation beyond the specialty practice setting. Of course, endorsement by the CAP Cancer Committee is not necessary for a protocol to be highly valuable as an educational or quality improvement tool. The pheochromocytoma protocol provides useful guidance in a highly structured, user-friendly format from recognized experts in endocrine pathology.