Protocol Development

In general, the structured pathology reporting protocols cover malignant entities, either alone or in association with other pre-cancerous or non-invasive components. Protocols do not cover non-malignant entities alone except in certain circumstances:

  • For anatomical areas, such as the heart and central nervous system, benign tumours maybe included in the scope of the protocol as even a benign conditions have serious prognostic implications.
  • Tumours of uncertain malignant potential. 
  • In cases where in-situ neoplasia is relevant, both invasive and non-invasive tumour components may be included.

Each cancer protocol is developed under a quality framework which dictates both how the protocols look as well as what should be included.

Work on the Framework was undertaken by a Framework Committee and was based on the National Pathology Accreditation Advisory Committees (NPAAC) structure with a view to their future incorporation into NPACC standards. The Framework committee was comprised of a team of pathologists, Michael Legg (President of the Health Informatics Society of Australia - HISA), and the project manager for structured reporting. Input from a team of medical writers, Biotext, fine tuned this initial version into documents that could be used to edit the initial six cancer specific protocols and all subsequent protocols.

These documents are designed for use by expert committees developing a new protocol or revising or updating an existing protocol for structured pathology reporting of cancer. The Framework documents consist of a word template and a general guideline document. The aim is to ensure that protocols produced for different tumour types have a consistent look and feel, and contain all the parameters needed to guide management and prognostication.

Updates to the Framework documents are also expected in the future as additional protocols are developed and general themes and issues arise.

The release strategy document:

  • Explains the process of creating a new edition and what constitutes a new or updated edition of the published cancer protocols
  • Documents the key features such as referencing, style guides, numbering etc to be maintained during updates to published protocols
  • Describes the process flow for the release of an updated protocol
  • Provides a guide to the expected release schedule for updates to published protocols.

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