Professional Guidelines & Consensus Documents Policy

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Professional Guidelines include strategies, information, and specific, graded recommendations that assist physicians and other healthcare practitioners in making decisions about appropriate measures of care for specific clinical circumstances. Consensus Documents summarize available information and supply general recommendations on complex or controversial areas of patient care.

Guidelines must include the following components:

  • A development process that involves multi-disciplinary and broad geographic representation among the content contributors
  • A comprehensive literature search and expert opinion which provides the evidence for graded recommendations
  • Specific recommendations which include a formal grading based on the quality of available evidence; such grading formulations to include an evaluation of benefits, harms, burdens, and costs

Consensus Documents must include the following components:

  • A development process that involves multi-disciplinary and broad geographic representation among the content contributors
  • A comprehensive literature search and expert opinion which provide the evidence for general recommendations
  • Consensus documents do NOT include individual recommendations that are graded by quality of available evidence
Full S&G Document Development Policies and Procedures
Identification of Need Applications Writing Committee Invitations / Conflict of Interest Management Document Writing Policies Document Writing Process Document Review and Approval Process Publication
Identification of Need
  1. The Standards and Guidelines (S&G) Committee will issue a request every March 1 to the Interdisciplinary Network (IDN) Steering Committees to consult with the members of their relevant Professional Communities and develop the following for presentation to the S&G Committee by June 1:
     
    • A list of the existing and in-development ISHLT S&G Documents, including those in which ISHLT is a joint collaborator or endorser
    • A list of existing and in-development S&G Documents promulgated by other relevant organizations and in which ISHLT is not involved
    • An assessment of these documents in terms of their relevance to each of the ISHLT Professional Communities and Interdisciplinary Networks
    • An assessment of these document in terms of their relevance from a national or international perspective (international relevance is strongly preferred).  
    • An assessment of these documents in terms their need for revision to reflect recent changes in practice
    • An assessment of these documents in terms of any areas of overlap and or disagreement between ISHLT documents and those of other organizations 
    • An assessment of any areas of practice where no relevant S&G Documents exist and for which there is a need for such to be developed
    • A summary list including:
      • What new documents are needed (these must be listed in rank order of importance, from the perspective of the IDN Steering Committee, based on input from the Professional Communities)
      • What existing documents are in need of revision
      • Which of the documents would benefit from development in collaboration with other organizations (such organizations are to be listed)
      • The rationale for any recommended collaborations, including benefits to ISHLT and to the partner organization(s)
      • Which of the documents would benefit from endorsement by other organizations (such organizations are to be listed)
      • The rationale for any recommended endorsements, including benefits to ISHLT and to the endorsing organization(s)
     
  2. The S&G Committee will review the reports from the IDN Steering Committees and develop a list of recommendations regarding the development of new or revised S&G Documents in the coming 12-18 months, listed in priority order and including the following information for each document:
     
    • IDN Steering Committee recommending the document
    • Type of document needed (Guideline, Consensus Statement, Standards Document)
    • Desired collaborative organizations, if any
    • Desired endorsing organizations, if any
    • Geographic areas of the world to which the document is relevant
    • Professional Communities to which the document is relevant 
    • Recommended publication plan (see publication section for options)
       
    These recommendations will be presented to the Publications Oversight Committee (POC) by July 1.
     
  3. The POC will review the list of recommendations from the S&G Committee and the reports from the IDN Steering Committees in light of the Society’s goals, objectives, and strategies and will develop a final list of priority S&G Documents to be developed or revised in the coming year to include:
     
    • Expectations regarding collaboration with / endorsement from other organizations
    • The intentions of the JHLT Editor regarding the publication of the document (see publication section for options).
    • Languages into which each document should be translated (if any)
     
  4. This list will be finalized and presented to the Board of Directors by August 1 for approval. Such approval must include approval of intended collaborations with / endorsements from other organizations, intended publication plans, and intended translations, along with appropriate funding for the latter.
     
  5. Individual ISHLT members may make recommendations to the Professional Community leaders and IDN Steering Committees throughout the year regarding the development of S&G Documents. The decision to submit such recommendations to the S&G Committee for consideration is at the discretion of the IDN Steering Committees. 
     
  6. An IDN Steering Committee may submit recommendations to the S&G Committee at times during the year other than those described in the above Statement of Need process. The S&G Committee may choose to recommend such documents to the POC for approval or may choose to hold the recommendation for processing in accordance with the standard annual process and timeline described above.  
     
    Any such recommendations to the POC for approval must include the following information:
    • The rank order of importance of the proposed document in comparison with the rank order of documents presented in the most recent list of recommendations submitted to the POC
    • Whether the document would benefit from development in collaboration with other organizations (such organizations are to be listed)
    • The rationale for any recommended collaborations, including benefits to ISHLT and to the partner organization(s)
    • Whether the documents would benefit from endorsement by other organizations (such organizations are to be listed)
    • The rationale for any recommended endorsements, including benefits to ISHLT and to the endorsing organization(s)

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Applications
  1. Initial Applications
     
    1. Following approval by the Board of the Publications Oversight Committee’s (POC) recommendations, staff will communicate the decision and associated expectations to the relevant Interdisciplinary Network (IDN) Steering Committee and request that they submit an Initial Application for the development / revision of the specified S&G document.
       
    2. The IDN Steering Committee is then responsible for the following:
       
      • Consulting with members of the Network and relevant Professional Communities as needed, including for the identification of Project Leaders and Section Leaders
      • Completing the Initial Application, taking care to ensure that the document will be maximally relevant to the various Professional Communities
      • Submitting the Initial Application to ISHLT staff for review and approval by the Standards and Guidelines (S&G) Committee
         
    3. Project Leaders and Section Leaders must be current ISHLT members at the time of appointment and throughout the duration of the project and may not be current members of the ISHLT Board of Directors, POC, IDN Steering Committees, or the S&G Committee. Exceptions can be requested and reviewed by the Publications Oversight Committee as needed.
       
    4. The S&G Committee will review the Initial Application and vote to approve it, return it for revisions, or not approve it.
       
    5. Two (2) weeks should be allowed for the Initial Application review and decision process.
       
    6. Staff will communicate the S&G Committee decision to the IDN Steering Committee.
       
    7. Staff will then issue invitations to the Project Leaders and Section Leaders, provide details of the proposed project, and collect Conflict of Interest Disclosure information.
       
    8. Once the Project Leaders and Section Leaders have accepted their invitations, staff will request that the Project Leaders and Section Leaders complete and submit the Follow-up Application within six (6) weeks. 
     
  2. Follow-Up Application
     
    1. The Project Leaders and the Section Leaders are responsible for working with the leaders of the relevant Professional Communities to complete and submit the Follow-up Application to the ISHLT staff for review and approval by the Standards and Guidelines (S&G) Committee.
       
    2. Six (6) weeks should be allowed for the development of the Follow-up Application and its submission to ISHLT staff.
       
    3. Writing Committees must be composed to ensure that the interests of the relevant Professional Communities are adequately represented, that a broad geographic perspective will be achieved, and that genders and generations are adequately represented.
       The Society strongly encourages the inclusion of Early Career Professionals (<6 years out of formal training) in the S&G Document writing process, especially if they are paired with senior or mid-career mentors.
       
    4. Members of the Writing Committee and Expert Reviewers must be ISHLT members at the time of appointment and throughout the duration of the project. Non-members will be considered in exceptional circumstances where the necessary expertise does not exist among the members, however, in such circumstances, the better approach would likely be to develop the document jointly with an organization whose members possess the necessary expertise.
       
    5. The S&G Committee will review the Follow-up Application to ensure that the table of contents and the content contributors are reflective of the identified relevant Professional Communities and provide geographic, gender, and generational diversity.
       
    6. Once these conditions are met, the S&G Committee will vote to approve the Follow-up Application and will submit it to the Publications Oversight Committee (POC) for final approval.
       
    7. Two (2) weeks shall be allowed for review and approval of the Follow-up Application by the S&G Committee.
       
    8. The POC will review the S&G Committee’s decision regarding the Follow-up Application and will provide final instructions regarding publication plans and endorsement (if any).
       
    9. One (1) week shall be allowed for POC review and approval of the Follow-up Application.
       
    10. Staff will communicate the decision of the POC to the S&G Committee and to the Project Leaders and Section Leaders and will provide instructions regarding next steps and publication / endorsement plans.

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Writing Committee Invitations / Conflict of Interest Management
  1. Following approval of the Follow-up Application by the Publications Oversight Committee (POC), staff will issue invitations to the Sub-Section Leaders, Writing Committee members, and Expert Reviewers, including details of the proposed project, writing assignments, the approved timeline, and publication / endorsement plans, and will collect Conflict of Interest Disclosure information.
     
  2. All individuals involved in the development of the S&G document are required to adhere to ISHLT’s conflict of interest policies.
     
  3. Staff will work with the POC to ensure that no more than 49% of all individuals involved in the development of the S&G Document have current conflicts of interest relevant to the subject matter of the S&G Document. If more than 49% have relevant COI, the Project Leader will identify alternate Writing Committee members/Expert Reviewers to be invited.
     
  4. Once all Sub-Section Leaders, Writing Committee members, and Expert Reviewers have accepted, staff will notify the Project Leaders and Section Leaders.
     
  5. In collaboration with staff, Project Leaders and Section Leaders will then communicate detailed instructions, including Policies for the writing of S&G Documents and the deadlines for document development, to the Writing Committee members and the writing process will begin.  Staff will also distribute the master COI spreadsheet and COI policies to all individuals.

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Document Writing Policies
  1. S&G Documents should be created as a single manuscript rather than multiple papers.
     
  2. If multiple papers are strongly preferred by the Project Leads, the rationale for such must be outlined in writing and in detail to the JHLT Editor and must be agreed to by the JHLT Editor at the time the Follow-up Application is approved.
     
  3. The typical length of a full S&G Document should not exceed 25,000 words, and an Executive Summary should not exceed 5,000 words.
     
  4. Approval for documents exceeding the above limits must be obtained from the JHLT Editor in advance.
     
  5. The structure of full S&G Documents must adhere to the ISHLT S&G Document Writing Policies (under development)
     
  6. The structure of the Executive Summary must adhere to the ISHLT S&G Document Writing Policies (under development).
     

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Document Writing Process
  1. The Project Leaders and Section Leaders are responsible for overseeing and managing the engagement of the Sub-Section Leaders and Writing Committee members and monitoring their adherence to the policies and procedures and to the established deadlines and timetable.
     
  2. All work on the development of S&G Documents shall take place via telephone, email, and online ISHLTconnect discussion forums.  ISHLT staff will arrange for conference calls and ISHLTconnect discussion forums for the Writing Committees.
     
  3. A face to face meeting of the Writing Committee members or Project Leaders/Section Leaders/Sub-Section Leaders at the ISHLT Annual Meeting will be arranged upon request.  Meeting space will be provided, but no AV equipment/labor or food and beverage will be provided.  No travel expenses associated with such a meeting will be reimbursed by ISHLT.
     
  4. Staff will check in with the Project Leaders once a month to ensure that work is progressing in accordance with the approved timetable.  If the project is falling behind, staff will notify the Chair of the Standards and Guidelines (S&G) Committee. If the project is falling more than 3 months behind, staff will notify the Chair of the Publications Oversight Committee (POC).  At that time, a revised timetable, an explanation for the delay, and a plan for preventing further delays must be submitted by the Project Leaders to the S&G Committee and the POC for review and, if necessary, intervention and course correction.
     
  5. IMPORTANT NOTE: If the publication decision made at the time of approval of the Follow-up Application is for an Executive Summary to be published in JHLT, the Executive Summary MUST be submitted for review and approval at the same time that the full document is submitted for such.

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Document Review and Approval Process
  1. Staff will monitor and track the flow of documents through the review and editing process and will notify responsible parties when deadlines have not been met.
     
  2. The review and comment period for each step shall not exceed 2 weeks except under unusual circumstances.
     
  3. Initial drafts will be submitted by the Writing Committee members for review and comment by the Section/Sub-Section Leaders.
     
  4. Revised drafts incorporating comments/revisions from Section/Sub-Section Leaders will be developed by the Writing Committee members and will be submitted for review/editing by the Section/Sub-Section Leaders. At this time, staff will also notify the Expert Reviewers to be prepared for the forthcoming document.
     
  5. Once the revised drafts have been finalized by the Section/Sub-Section Leaders, the drafts will be provided to the Project Leaders for collation and final editing and for the development of the Executive Summary, if relevant.
     
  6. Staff will coordinate the review of the draft document (and Executive Summary) by the assigned Expert Reviewers and the members of the appropriate Interdisciplinary Network (IDN) Steering Committee.
     
  7. Staff will collate the comments from the Expert Reviewers and the IDN Steering Committee members and provide them to the Project Leaders.
     
  8. The Project Leaders, with assistance from the Section Leaders if desired, will create a Revised Final Draft of the document (and the Executive Summary), incorporating comments from Expert Reviewers and IDN Steering Committee members.
     
  9. Staff will then submit the Revised Final Draft (and Executive Summary) to the members of the relevant Interdisciplinary Networks for peer review.
     
  10. Staff will collate the comments from the peer review process and submit them to the Project Leaders for consideration and, if warranted, incorporation into a FINAL Final Draft of the document (and Executive Summary). The FINAL Final Draft of the document must have been approved by all members of the Writing Committee prior to submission to the Standards and Guidelines (S&G) Committee and Publications Oversight Committee (POC) for review and approval.
     
  11. Staff will submit the FINAL Final Draft (and Executive Summary) to the S&G Committee and the POC simultaneously for review and approval.
     
  12. Staff will submit the POC-approved document (and Executive Summary) to the Board of Directors for approval.
     
  13. Once approved by the Board, staff will notify the Project Leaders and the JHLT Editor of the Board’s decision and direct the Project Leaders to submit the manuscript (and the Executive Summary, as appropriate) to the JHLT for publication.

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Publication
  1. Publication options for Professional Practice Guidelines and Consensus are as follows:
    1. Publication of the full S&G Document in the print and digital JHLT
       
    2. Publication of an Executive Summary only in the print and digital JHLT with the full S&G Document published as supplementary e-only files (requires Board approval of a budget for professional medical editing of the supplementary e-files). Supplementary e-only files must include a table of contents and must be tagged to the main components of the Executive Summary. If the supplementary e-only files contain separate “task force” documents authored by a distinct set of authors, these will not be credited separately as de novo papers and those authors will not receive publishable credit.
     
  2. The JHLT has the right of first refusal for publication of the full S&G Document and/or the Executive Summary.
     
  3. Board-approved S&G Documents will not undergo peer / editorial review by the JHLT Editorial team (copy editing and medical editing will be provided by the publisher), however, the following specifications must be adhered to for all documents published in the JHLT:
     
    • S&G Documents should be created as a single manuscript rather than multiple papers.
       
    • If multiple papers are strongly preferred by the Project Leads, the rationale for such must be outlined in writing and in detail to the JHLT Editor and must be agreed to by the JHLT Editor at the time the Follow-up Application is approved.
       
    • The typical length of a full S&G Document should not exceed 25,000 words, and an Executive Summary should not exceed 5,000 words.
       
    • If a longer document is deemed necessary by the Project Leads, it will likely be necessary to pursue publication option #2 above. Approval for documents exceeding the above limits must be obtained from the JHLT Editor in advance.
       
    • Staff will provide a list of the Writing Committee members and Expert Reviewers and their Conflict of Interest Disclosures to the Project Lead for submission with the final, approved manuscript to the JHLT.
     
  4. The structure of full S&G Documents must adhere to the ISHLT S&G Document Writing Policies (under development).
     
  5. The structure of the Executive Summary must adhere to the ISHLT S&G Document Writing Policies (under development).
     
  6. The Project Lead is responsible for submitting the final approved document (and Executive Summary) to the JHLT in accordance with the process and standards established by the publisher. Such document must have been approved by all members of the Writing Committee prior to submission.
     
  7. All ISHLT S&G Documents published in the JHLT will be made available for free access to the general public on the JHLT website, with links to them created by staff on the S&G pages of the ISHLT website.
     
  8. The JHLT Editor reserves the right to make the final decision regarding publication and associated specifics of all S&G Documents. In the event of a disagreement, the Editor will discuss his/her thoughts with the POC and the ISHLT Executive Committee prior to reaching a decision.

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Full S&G Document Development Policies and Procedures