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.