Authoring Process

Guideline development:

  1. The author prepares an active version of the application (guideline, protocol, care pathway, clinical algorithm or other process) using an appropriate formalism and authoring tools, providing also access to human readable supporting documentation and evidence links.
  2. The formal knowledge content is checked for syntactic correctness and logical adequacy. This includes running the application against test clinical data to ensure appropriate decision quality standards are met.
  3. The application is submitted to a publisher’s web site as a set of XML files. The submission will include the clinical test data against which the application has been validated.
  4. The publisher’s software services register the submission and screen it against “house” technical requirements (e.g. compliance with syntax of chosen representation standard, use of standard clinical terms and/or a standard medical knowledge template). Submissions that fail screening are returned with an automatically generated syntactic report for correction and resubmissi
  5. An adapted form of peer review follows successful submission:
    • The publisher holds a database of reviewers and their areas of clinical expertise and interest. Software creates a shortlist of potentially appropriate reviewers for selection by a responsible editor. A request for review and a link to the application on the publisher's private repository are sent to preferred reviewers.
    • Reviewers review the supporting documentation and evaluate the decision support and other guidance services by running the application against sample cases from their own practice. An anonymous report is prepared and sent to the editor and authors in the usual way, though this may be accompanied by the additional test data that have been used.
  6. If the publisher follows the standard peer review process for conventional publications, a decision to accept, reject or request revisions may be made at this point. However, internet-based publishing also offers other possibilities, such as a further open discussion step in which applications and reviews are made more widely available for a limited period to the specialist clinical research community. This would permit interaction between authors, editors and the specialist community to try to improve the submitted application.
  7. Accepted applications appear as usable services on the publisher’s web site.
  8. The publisher may adopt a further step of arranging for open commentary by the general medical community. This will empower non-research clinicians not only to consult the active guideline as part of their clinical routine, but also to make comments, report adverse or other significant events, capture patient data into a central research database. This process would help close the loop between the clinical research and guideline development world and the wider clinical world, and could potentially include patients.