REQUEST FOR PROPOSALS: Clinical Practice Guideline on LIBERATION FROM MECHANICAL VENTILATION in Adults and/or Children
In this Announcement, the Documents Development and Implementation Committee (DDIC) of the American Thoracic Society (ATS) solicits proposals for the development of a clinical practice guideline for liberating patients with respiratory failure from mechanical ventilation in adults and/or children. This topic was identified and prioritized by the ATS Planning Committee, and subsequently approved by the ATS Executive Committee.
Description: Practices for liberation from mechanical ventilation have been evaluated in dozens of randomized, clinical trials, but best practices have not been codified in evidence-based guidelines. To fill this important translational gap, the ATS solicits proposals from multidisciplinary teams to develop a state of the art, evidence-based, clinical practice guideline. Methods for guideline development will adhere to the policies and procedures set forth in the ATS Guidelines Packet (available on the DDIC website; see URL under “Resources for applicants”). Development and implementation will be overseen by the DDIC, in concert with Jan Brozek, MD, PhD (ATS Methodologist) and Kevin Wilson, MD (ATS Documents Editor).
Eligibility: At least one Co-chair of the development team must be an ATS member. Other participants should include ATS members and non-members with relevant experience and expertise, as necessary.
Application: We strongly encourage applicants to review the ATS Guidelines Packet and the AGREE II guideline quality instrument (both available on the DDIC website) prior to preparing the application, which should cover each of the following topics in sufficient detail to demonstrate feasibility, methodological rigor, and clinical expertise.
What are the specific questions to be addressed and recommendations to be made? Applicants should list all questions relevant to daily clinical practice that are to be covered by the guideline. Questions should be structured in PICO format, specifying the target patient population (P), the intervention or exposure (I), comparators (C), and outcomes of interest (O). While it is expected that the initial set of questions will undergo revision and refinement, applicants are encouraged to be as specific as possible about each one of the PICO elements.
What is the planned scope of the guideline? Applicants should clearly define the scope of the guideline, including which areas of care should be included and which can be deferred. In doing so, applicants should balance the desire to be comprehensive with the recognition that available resources are limited and that timely completion is paramount. A clinical practice guideline is not a comprehensive review article, but rather a systematically developed set of recommendations for practice in which there is an explicit and transparent link between the recommendations and the supporting evidence. Past experience with ATS guideline development groups indicates that the number of PICO questions should be limited to 7 or fewer. Depending on the volume of supporting literature, it is estimated that each PICO question will require ~100 person-hours of effort for systematic review alone, and another 50 person-hours to formulate and grade recommendations. Proposals that are judged to be overly broad in scope will be viewed less favorably.
Who are the proposed members of the development team and how will the final team be assembled? We request proposals from multidisciplinary teams that include not only those with relevant clinical expertise, but also those with expertise in methods of evidence-based medicine, systematic literature review and guideline development. Ideally, the project team should include two Chairs—one a clinical expert, and the other an expert in evidence synthesis and guideline development.
The ATS strongly encourages involvement of diverse stakeholders, each bringing a unique and important perspective to the process. For this guideline, the team should include clinical experts (including nurses and respiratory therapists), clinical researchers, one or more experts in systematic review and evidence-based medicine, a medical librarian, an expert in group facilitation and/or project management, a patient or patient representative, and one or more members to represent the perspective of payers and health plans. The role and qualifications of all proposed team members should be described in the application. Complete contact information should be provided for the project Chair(s). Note: all participants will be required to complete educational modules for documents development on the DDIC web page prior to beginning work on the project. In addition the Chair(s) will be required to attend a DDIC workshop, familiarize themselves with the ATS guideline development process, and agree to follow ATS methodology.
How will conflicts of interest (COI) be vetted and subsequently managed? At least one Chair and a majority of committee members should be free of financial conflicts of interest and must agree to remain free of conflicts for at least 1 year after publication of the guideline. Other procedures for managing financial and/or intellectual COI should be consistent with ATS policies. We encourage chairs to select panel members who are free of conflicts or with conflicts that are minimal and can be managed through current ATS procedures.
Who will perform the systematic reviews and what methods will be used? One or more members of the project team should have first-hand experience performing (and publishing) systematic reviews. We strongly encourage teams to identify and make use of recently published, high quality systematic reviews performed by others. Applicants are encouraged to recruit qualified junior members to help perform systematic reviews.
Who will synthesize the evidence and what methods will be used? One or more members of the project team should have first-hand experience using the GRADE approach for rating the quality of evidence and grading the strength of recommendations. The ATS plans to donate a limited amount of expert methodological support (~0.1 to 0.2 FTE) from the ATS Methodologist to help oversee guideline development, but this individual will not be available to perform the systematic review, evidence synthesis, or formulation and grading of recommendations without substantial involvement of the guideline panel.
What methods will be used to reach consensus about recommendations? Applicants should describe how recommendations will be proposed, vetted, discussed and finalized, especially for recommendations that are potentially controversial. In general, the ATS encourages guideline groups to reach consensus by whole group discussion rather than by voting. Experience with processes for reaching consensus should be described.
What are the plans for dissemination and implementation of the guideline? The guideline will be published in an ATS journal after an intensive process of peer review (overseen by Kevin Wilson, MD, ATS Documents Editor), stakeholder comment, and review by the ATS Board of Directors. In June of year 1, the project Chair is expected to submit a proposal for a symposium about the guideline at the International Conference. While we anticipate that additional implementation efforts will be funded separately, ideas for additional dissemination and implementation efforts should be described briefly. To facilitate planning for implementation, experts in quality of care, medical education and health communication should ideally be included in the project team. Proposals that explicitly address links between the guidelines and derivatives such as performance measures and educational materials will be viewed favorably.
How will the guideline be reviewed for currency and updated when necessary? ATS plans to move eventually to a model of sustainable or “living” guidelines, in which targeted updates, supported by updated literature searches and synthesis of evidence, can be performed periodically as needed. Applicants should describe their level of commitment to maintaining the currency and relevance of this guideline in the future, and describe procedures used to ensure that periodic review and revision are completed as efficiently as possible.
Budget: It is expected that most effort related to guideline development will be donated by the members of the project team. Justifiable expenses include those for literature searches, evidence synthesis, and travel reimbursement. Prior experience with Evidence-based Practice Centers and other independent contractors suggests that the cost of an outsourced systematic review is at least $5,000 to $10,000 per PICO question. The total budget should not exceed $35,000, although requests for additional funds will be entertained if a compelling rationale is provided.
Project timeline: The project should be completed in 2 years. The first year should be devoted to panel assembly, logistical planning, question formulation and refinement, and systematic literature review and evidence synthesis. Year 2 should include development and review of GRADE evidence profiles, formulation and grading of recommendations, vetting and approval of recommendations, and drafting the manuscript. A complete set of recommendations must be completed no later than May of Year 2 to enable programming of CME activities during the following year’s International Conference. The project team will be required to submit a renewal application for approval prior to receiving additional funding to support Year 2 activities, conditional on the demonstration of substantial progress during Year 1.
Deliverables: As part of the project timeline, the application should describe when each of the following products will be delivered. Deliverables include: (1) a list of team members with information about the role of each one, institutional and contact information and accompanying COI information; (2) a complete list of refined PICO questions; the literature search strategy (including dates and databases searched); (3) a list of included and excluded studies for each PICO question; an EndNote library that contains all included studies; (4) PDF copies of all included studies; (5) tables summarizing the methods, study quality and results of included studies; (6) GRADE evidence profiles for each PICO question; (7) a list of all recommendations, graded for strength and quality of supporting evidence; and the final text of the document. Note: It is ATS policy to strictly enforce the limit of 4500 words for the print version of clinical practice guidelines. Additional text (up to 10,000 words total), tables and/or figures can be placed in the appendices of an online-only supplement.
Applications should be complete but concise, and no more than 10 pages in length, including all tables and figures. References are not included in the page limit, however references should be limited to key publications in support of either the proposed methodology or the experience of the applicants. There is no need to provide background information about the clinical problem, its significance, or its relevance to the ATS. Applications should be prepared in 11-point font or larger, with 0.5 inch page margins or greater. Chair(s) should append copies of a NIH-style biosketch, but no other supplementary materials will be reviewed. Completed applications should be saved in Adobe pdf format and sent electronically to Judy Corn at firstname.lastname@example.org. The submission deadline is October 31, 2013.
Application review criteria
Applications will be reviewed by an ad hoc committee that includes representatives from the following ATS Committees and Assemblies: DDIC, Education, Quality Improvement, Planning, Critical Care, and the Program Review Subcommittee. Applications will be judged based on the qualifications of the team, the innovativeness of the methods, and the rigor of the approach. The review committee will identify the top proposals and select one for funding.
Resources for applicants
The following resources and other helpful information are available on the DDIC website (available at: http://www.thoracic.org/statements/document-development/index.php ). Developers are encouraged to review one or more recently published ATS guidelines, including guidelines for idiopathic pulmonary fibrosis and guidelines for the evaluation of suspected pulmonary embolism in pregnancy.
- 2013 Guidelines for ATS Documents
- GRADE statement
- AGREE II instrument
- Institute of Medicine standards for trustworthy systematic reviews and clinical practice guidelines
- Guidelines International Network standards for clinical practice guidelines
- ATS policies for managing conflict of interest