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Guidance Frequently Asked Questions
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What is a Clinical Guidance Document?

  • Addresses a clinically important topic (diagnostic-, therapeutic-, or laboratory-based) of broad clinical interest for which evidence-based guidelines and/or RCTs are lacking or are unlikely to be developed in future.
  • Provides guidance to clinicians for the care patients but not necessarily graded recommendations.
  • NOT related to a research initiative, a basic science topic, laboratory standardization or other non-clinical topics.
  • Published by JTH after screening by the G&G committee and scientific review by JTH (AE delegated to guidance manuscripts), using a concise and practical format.
  • Examples may include: thrombophilia testing after VTE; treatment of thrombosis at unusual sites; laboratory monitoring of NOACs.  

How does a Guidance Document differ from a Guideline Document?

  • A guideline document (a) addresses a topic in which there is moderate-to-high-quality evidence to inform best practices, (b) uses a structured process to summarize the evidence (i.e., systematic review), and (c) provides a standardized method to express a recommendation (i.e., Grade 1B).
  • To date, the ISTH has not formally adopted a guideline development process but may choose to do so in future.  

How does a Guidance Document differ from an SSC Communication? 

  • An SSC communication addresses a topic that is directed primarily to the work of researchers and laboratory-based specialists but may also have relevance to clinicians.
  • The G&G committee is not involved in developing or reviewing SSC Communications; SSC Communications, typically, are proposed and developed by subcommittees.
  • Published by JTH, after review by editorial board.
  • Examples may include: standard definition of bleeding for clinical trials, call to action for research (for researchers); standardized assay methods for oral Xa inhibitors (for laboratory specialists); and classification of bleeding in hemophilia, potency labelling of clotting factor concentrates (for clinicians).  

How does one develop a guidance document?

  • Guidance document proposals can originate from 3 sources:
    • SSC subcommittee Chair/Co-Chairs/interested collaborators;
    • wider ISTH membership;
    • members of the G&G Committee.
  • Guidance documents should be written by an international group of authors, ideally with representation from multiple continents, with involvement of 1-2 senior/established clinicians in the pertinent field.  

What is the review process for a guidance document?

This is a 3-step process:

  • The proposed topic and the proposed writing team are directed to the G&G committee for initial review (to assess appropriateness).
  • After initial approval by the G&G committee of the proposed topic and writing team, the writing team drafts the guidance document and it undergoes an initial review by the G&G committee to ensure it adheres to the formatting and style (e.g., concise, practical and usable by readers). This step may require a second review of G&G committee.
  • After final approval of the completed guidance document by the G&G committee, the document is sent to the JTH Editorial Office, and is directed to the Guidance Document Associate Editor for scientific peer-review (as with any JTH publication).    

Frequently Asked Questions

  • What if a guidance document is rejected by JTH for publication? Development of guidance documents (under the auspices of the G&G) is done with a view to publication, but publication is not assured and requires the peer-review process to be satisfied.
  • What if an ISTH member proposes a guidance document but has no affiliation with an SSC subcommittee? The G&G committee will direct this person to the appropriate subcommittee/Chair. If there is no relevant subcommittee to align with a topic, an ad hoc working party/group will be formed to develop the guidance document.
  • What if a guidance document becomes out of date? The G&G committee is working on a process to allow periodic updating of guidance documents to reflect new developments in the field. 
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