ISHLT Document Development Policy

Applications

Professional Guidelines, Consensus Statements, and Other Documents

1. Initial Applications
   1. Following approval by the Statements & Publications Oversight Committee (SPOC) of the Standards & Guidelines (S&G) Committee’s recommendations, staff will communicate the decision and associated expectations to the responsible Interdisciplinary Network (IDN) Steering Committee and/or Professional Community (PC) Leadership for each approved Professional Guideline, Consensus Document, or other document and request that they submit an Initial Application for the development/revision of the specified document.
   2. The IDN Steering Committee and/or PC Leadership is then responsible for the following:
      • Consulting with members of the Network and relevant Professional Communities as needed to identify Project Leads.
      • Completing the Initial Application, taking care to ensure that the document will be maximally relevant to the various PCs.
      • Submitting the Initial Application to ISHLT staff for review and approval by the Standards and Guidelines (S&G) Committee.
   3. Project Leads 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, SPOC, IDN Steering Committees, or the S&G Committee. Exemptions to this rule may be granted by the SPOC in exceptional circumstances where there is limited expertise within the Society. The proposed Project Leads must also reflect the diversity of the Society.
   4. The S&G Committee will review the Initial Application and vote to approve it, return it for revisions, or not approve it.
   5. Review of the Initial Application will be conducted at the first opportunity. 2-3 weeks will be allowed for the S&G Committee to complete their review.
   6. Staff will communicate the S&G Committee’s decisions to the responsible IDN Steering Committee and/or PC Leadership. If revisions are required, the feedback from the committee must be addressed and a response from the IDN Steering Committee and/or PC Leadership must be provided when the revised application is submitted for review.
      • In cases where the proposal was submitted via the online submission form, the submitter will also be notified of the S&G Committee’s decision. Should revisions be required, the submitter may collaborate with the responsible IDN Steering Committee and/or PC Leadership to develop a revised application and response.
   7. Following approval of the Application, staff will issue invitations to the Project Leads, provide details of the proposed project, and collect Conflict of Interest Disclosure information.
   8. Once the Project Leads have accepted their invitations, staff will request that the Project Leads complete and submit the Follow-up Application within 6 weeks.
2. Follow-Up Application
   1. The Project Leads are responsible for working with the leaders of the relevant Interdisciplinary Network (IDN) Steering Committees and Professional Community (PC) Leadership 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. Writing Committees must be composed to ensure that the interests of the relevant IDN and PCs are adequately represented, that a broad geographic perspective will be achieved, and that gender diversity is adequately represented. Writing Committees must also include Early Career Professionals (<6 years out of formal training). Project Leads are encouraged to pair them with senior or mid-career mentors.
   3. Industry Representatives are not permitted to participate on the Writing Committee of any ISHLT document. Should insight on certain industry-related topics be necessary, Project Leads can communicate with Industry Representatives and cite those conversations within the document.
   4. Methodology: The methodology used to develop an ISHLT document will depend on the document type and will be decided by the Project leads in conjunction with the responsible IDN Steering Committee and/or Professional Community Leadership with oversight from S&G. It is expected that, irrespective of the overall methodology chosen, a comprehensive literature review will be undertaken to underpin the project.
      • If a consensus methodology is used, the methodology should be outlined in detail, and it is expected that the full writing group has the opportunity to vote on/abstain from each statement.
      • Completed ISHLT documents should focus on providing expert guidance, rather than repeating information compiled during the literature review. Documents should provide recommendations, supported by evidence from the literature review. If a recommendation cannot be made, this too should be supported by evidence from the literature review.
   5. Members of the Writing Committee 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 membership.
   6. Expert Reviewers are not required to be ISHLT members at the time of application submission but MUST be ISHLT members at the time the document is complete and ready to undergo review.
   7. The Standards & Guidelines (S&G) Committee will review the Follow-up Application to ensure that the scope is appropriate for the topic and can be accomplished within the 25,000-word limit, the content contributors are reflective of the identified relevant IDN and PCs and provide geographic, gender, and generational diversity, the timeline for development is suitable and the methodology is appropriate.
      • If these conditions are not met, the S&G Committee may return the application to the project leads for revision. If revisions are required, the feedback from the committee must be addressed and a response from the Project Leads must be provided when the revised application is submitted for review.
      • Once these conditions are met, the S&G Committee will vote to approve the Follow-up Application and will submit it to the Statements & Publications Oversight Committee (SPOC) for final approval.
   8. Review of the Follow-up Application will be conducted at the first opportunity. 2-3 weeks will be allowed for the S&G Committee to complete their review.
   9. The SPOC will be allowed 1-2 weeks to review the S&G Committee’s decision regarding the Follow-up Application and provide final recommendations regarding publication plans and endorsement (if any).
   10. Staff will communicate the decision of the SPOC to the S&G Committee and to the Project Leads and will provide instructions regarding next steps.

Health Policy Guidance Statements

1. Proposals to develop Health Policy Guidance Statements must include:
   1. The issue which the statement will address.
   2. The urgency of the issue.
   3. A summary of the need for the statement and reasoning for urgency.
   4. The audience for the statement (regulatory bodies, health care providers, patients, etc.).
   5. A list of the Society’s Professional Communities and Interdisciplinary Networks to which the issue is relevant.
   6. Existing statements by other organizations on the same or a closely related topic.
   7. Organizations with whom collaboration on a statement would be valuable.
2. The Statements & Publications Oversight Committee (SPOC), along with invited representatives from the Standards & Guidelines (S&G) Committee with relevant expertise, will review the proposal and the need for a rapid response on behalf of the Society. If the issue is not determined to be urgent, the document should go through the traditional approval pathway described above.
3. If it is determined that the statement is warranted with urgency, the SPOC will make a recommendation to the ISHLT Board (or Executive Committee) for its development. Such recommendation must include:
   1. Summary of issue and need for statement.
   2. Recommended scope of statement.
   3. Recommended collaborating organizations (if any)
   4. Level of urgency and recommended date for completion of the document.
   5. Recommended Project Leads, selected with collaboration with the relevant Interdisciplinary Network (IDN) Steering Committee(s).
   6. Recommended Project Leads must be current ISHLT members at the time of appointment and throughout the duration of the project and must also reflect the diversity of the Society.
   7. Recommended publication/dissemination vehicles.
4. If the Board of Directors or Executive Committee approves the recommendation, Staff will communicate the decision to the submitter and will provide instructions regarding next steps.

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Writing Committee Invitations / Conflict of Interest Management

1. Following approval of the Follow-up Application or proposal, staff will issue invitations to the Writing Committee members. Invitations will be drafted by project leads and should include details of the proposed project, writing assignments, planned author credit, publication/endorsement plans and instructions on submitting a Conflict of Interest (COI) Disclosure form.
2. All individuals involved in the development of ISHLT Documents are required to adhere to ISHLT’s conflict of interest policies.
3. Once all Section Leaders, Sub-Section Leaders, and Writing Committee members have accepted their invitations, staff will notify the Project Leads.
4. Staff will work with the Project Leads to schedule a kick-off meeting with all invited collaborators, during which Project Leads will communicate detailed instructions, including policies and deadlines for document development. The writing process (or method of consensus, if applicable) will begin after that meeting.
5. Leads may not invite replacement authors without review by S&G. Once approval is granted, staff will issue the invitation to the replacement author(s).

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Document Writing Policies

1. All ISHLT 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 and provided to the Standards & Guidelines (S&G) Committee and Statements & Publications Oversight Committee (SPOC) for approval. Approval must be received from both committees before writing begins.
3. All documents should not exceed 25,000 words. This limit excludes tables and references and will be enforced by the S&G Committee and the SPOC. Documents that are more narrowly focused or have a limited scope should be considerably shorter.
4. All ISHLT Documents will be accompanied by a Perspectives Document for print publication in JHLT, which should highlight the key takeaways from the document and encourage readers to seek the full document online. Development of the Perspectives Document should be conducted by the Project Leaders after Expert and Peer Review processes have been completed to best reflect the final version of the full manuscript.
5. It is strongly recommended, but not required, that documents include Tables/Figures to graphically present high yield points and recommendations.
6. All documents must be developed using the ISHLT S&G Document Writing Template and Instructions provided by ISHLT staff.
7. Project Leads are responsible for overseeing and managing the engagement of the Writing Committee members, and monitoring their adherence to the policies and procedures and to the established deadlines and timetable.
8. All work on ISHLT Documents shall take place via telephone, virtual meetings, and email. Upon request, ISHLT staff will arrange for conference calls and ISHLTconnect discussion forums for the Writing Committees.
9. A face-to-face meeting of the Writing Committee members or project leadership at the ISHLT Annual Meeting may be arranged upon request. Meeting space will be provided if available, 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.
10. Staff will check in with the Project Leads once a month to ensure that work is progressing in accordance with the approved timetable.
    • If a Professional Guideline or Consensus Document is falling behind schedule, 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 Statements & Publications Oversight Committee (SPOC). 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 SPOC for review and, if necessary, intervention and course correction. Such intervention may include, but is not limited to, direct oversight of remaining development stages, the institution of periodic check-ins with the Project Leaders, or replacement of Project Leaders.

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Document Review and Approval Process

1. Internal Review
   1. Initial drafts will be submitted by the Writing Committee members for review and comment by the Section/Sub-Section Leaders.
   2. Revised drafts incorporating comments/revisions from Section/Sub-Section Leaders will be developed by the Writing Committee members and will be submitted for further review/editing by the Section/Sub-Section Leaders.
   3. 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.
2. Peer and Expert Review
   1. While the document is undergoing final collation and editing by the Project Leads, staff will invite the approved Expert Reviewers and collect their Conflict-of-Interest (COI) Disclosures.
   2. Staff will coordinate the expert review of the draft document by the assigned Expert Reviewers – Project Leads should not send the draft document directly to the Expert Reviewers. The draft will also be distributed to members of the appropriate Interdisciplinary Network (IDN) Steering Committee(s), Professional Community (PC) Leadership, and members of the relevant IDN(s) and PC(s) for peer review.
   3. The review and comment period shall not exceed 3 weeks except under unusual circumstances.
   4. Once the review and comment period has ended, staff will collate the comments received during the Expert and Peer Review processes and provide them to the Project Leads.
   5. Project Leaders, with assistance from the Section Leaders if desired, will incorporate feedback from Expert and Peer Reviewers, create a Revised Final Draft of the document, and develop a response to each of the individual reviewer comments.
   6. Staff will submit the Revised Final Draft and comment responses to anyone who participated in Expert or Peer Review for their approval. 1-2 weeks shall be allowed for this review.
   7. If there is any additional feedback from the reviewers, Staff will collate the comments and submit them to the Project Leads for consideration and, if warranted, incorporation into a Final Draft of the document.
   8. The Final Draft of the document must be approved by all members of the Writing Committee prior to submission to the Standards & Guidelines (S&G) for review.
3. Final Review
   1. Staff will submit the approved Final Draft of all documents and the accompanying Perspectives Document to the Standards & Guidelines (S&G) Committee for review.
   2. Upon approval by the S&G Committee, staff will submit the Final Draft and Perspectives Document to the Statements & Publications Oversight Committee (SPOC) for review.
   3. Should revisions be required by the S&G Committee or the SPOC, Project Leads will be required to complete the necessary revisions and resubmit the Revised Final Draft and Perspectives Document, along with a response to the feedback from the Committee(s).
   4. Upon approval by the SPOC, staff will submit the Final Draft and Perspectives Document to the Board of Directors for approval.
   5. Once approved by the Board, staff will notify the Project Leads and the JHLT Editor-in-Chief of the Board’s decision and direct the Project Leads to submit the manuscript and accompanying Perspectives Document to JHLT for publication.

   Health Policy Guidance Statements

   1. Expert/Peer Review, and Final Review will be conducted as outlined above except in cases where time is of the essence. In those circumstances, the Standards & Guidelines (S&G) Committee and Statements & Publications Oversight Committee (SPOC) will conduct their Final Reviews simultaneously.

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Publication

1. All ISHLT Documents are to be published in full in the digital version of JHLT, with accompanying Perspectives Documents published in print issues of JHLT. ISHLT Documents may be selected for full print publication at the discretion of the JHLT Editor-in-Chief.
2. The Project Leads are responsible for submitting the final approved ISHLT Document and Perspectives Document to JHLT in accordance with the process and standards established by the publisher.
3. ISHLT Staff will provide a list of document contributors and their Conflict of Interest (COI) Disclosures to the Project Leads for submission with the final approved manuscript to the JHLT.
4. Board of Director-approved ISHLT Documents will not undergo additional peer / editorial review by the JHLT Editorial team. Copy editing and medical editing will be provided by the publisher.
5. All ISHLT Documents will be formatted for publication by the publisher using the Standard & Guidelines (S&G) Publication Template. All Perspectives Documents will be formatted using the Perspectives Publication Template and will include a QR code for easy access to the online publication of the full manuscript.
6. Publication dates for all ISHLT Documents will be determined by ISHLT Staff. Documents will be placed under embargo by the publisher until the selected date.
7. All ISHLT Documents published in JHLT will be made available for free access to the general public on the JHLT website. A copy of the document and the accompanying Perspectives Document, links to the published article in JHLT, and any associated materials, including those developed for promotional purposes, will be made available on the ISHLT website.
8. The JHLT Editor-in-Chief reserves the right to make the final decision regarding publication and associated specifics of all ISHLT Documents. In the event of a disagreement, the Editor-in-Chief will discuss his/her thoughts with the Statements & Publications Oversight Committee (SPOC) prior to reaching a decision.

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