Guidelines and Guidance Committee Standard Operating Procedure for the Involvement and/or Endorsement of Clinical Practice Guidelines by non-ISTH Societies/Groups

The goal of this page is to define the policies and procedures for reviewing requests from outside organizations to participate in or to endorse clinical guidelines in the field of thrombosis and hemostasis.

The ISTH accepts requests from other organizations to participate in their guideline development.  Requests will be reviewed by the following criteria*:

• The Clinical Practice Guideline (CPG) topic is of interest to the broad membership of ISTH and is applicable to multiple regions around the world.
• The CPG topic is developed by a medical society/group with expertise in the topic and is done independently of any commercial interest.
• The CPG contains systematically developed practice recommendations intended to improve the care of patients.
• The CPG is based on a systematic review of the evidence, which includes: a description of the literature search strategy, a description of the study selection process, and the synthesis and summation of evidence.
• The CPG addresses the potential benefits and harms of the recommended management and/or treatment for patients and, where appropriate, alternative options.
• The CPG content is recent (i.e., evidence reviewed within the past 5 years), and is available in English to the public (for free or for a charge).
• The CPG will provide written acknowledgement of the support and, where appropriate, participation of the ISTH in the CPG development process.

*Adopted from the Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse.

Requests for Collaboration on Clinical Practice Guidelines (CPG) Development by Outside Organizations

Requests for ISTH involvement must contain the following:

1. Statement on the intent of the guideline: audience, key clinical issues to be addressed, background.
2. Statement on why the organization would like ISTH to participate in the development process.
3. Statement on the guideline development methods to be used, including intended approaches to management of conflicts of interest.
4. Statement of ISTH’s rights and responsibilities regarding approval, ownership, which may require legal review.
5. Statement of the rights and responsibilities of ISTH’s representatives to the process, including voting, authorship, work products, financial commitment, etc.
6. Proposed timelines and estimated publication date.
7. Statement of target journal, with the potential for publication in JTH if another journal is not available nor suitable.

Process for outside CPG development

1. The Guidance and Guideline (G&G) Committee will receive a request from an outside organization to collaborate on a planned CPG.  Requests will require 3 weeks to review.
2. The G&G Committee will screen the CPG request to assess suitability for involvement based on the abovementioned criteria.
3. After viewing the CPG request, the G&G Committee will provide a statement to ISTH Council regarding the suitability of ISTH involvement in the guideline development. 
   The G&G Committee may decline involvement in activity that is beyond the scope of the Committee’s manpower or financial resources.
4. After review by ISTH Council, a final decision will be communicated to the outside organization.
5. If approved, the G&G Committee will assign two Reviewers (ISTH members), one of whom is a G&G Committee member, to participate in the CPG development process. Biannual updates on the guideline development must be submitted to the G&G Committee for reporting to ISTH Council.
6. Published guidelines will be added to the ISTH website and distributed electronically to ISTH members with the proviso that copyright issues have been addressed.

Requests for Endorsement of Clinical Practice Guidelines by Outside Organizations

In the absence of ISTH involvement in the guideline development process by other organizations, the ISTH will consider endorsement of guidelines if the following conditions are met:

• The guideline must be in a relatively final version but unpublished.
• The publication plan must be clearly articulated.
• The document must include a clear indication by the organization of the purpose of the CPG and the targeted audience.

Requests for endorsement must contain:

1. Statement on why the organization would like ISTH endorsement
2. Statement on the methodology used to create the guideline
3. Statement on how conflict of interest was managed throughout the process
4. Statement on how the ISTH would be recognized for endorsement;  if there are other rights and responsibilities associated with endorsement
5. Proposed timeline and estimated publication date

Process for outside CPG endorsement

1. The G&G committee will receive a request from an outside organization to review the developed CPG.   Requests will require 3 weeks to review.
2.  The G&G committee will screen the CPG to assess suitability for endorsement based on the above conditions.
3.  After viewing the CPG request, the G&G committee will provide a statement to ISTH Council regarding the suitability of ISTH endorsement of the CPG. 
4. After review by ISTH Council, a final decision will be communicated to the outside organization.
5. If approved, the G&G committee will assign two Reviewers (ISTH members), one of whom is a G&G committee member, to participate in the review process prior to publication. The Reviewers will provide a statement to the G&G committee regarding the suitability of the final CPG for ISTH endorsement.
6. The G&G committee may request additional review of the final CPG product by the SSC Executive and/or ISTH Council before a final approval is granted (e.g., in the case of endorsement of large, wide-ranging CPGs, such as those by the ACCP, ESC)

Click here to submit a request for endorsement of a guideline project.