Document Development

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Module-A For Document Developers

Vignette Set A: For all developers

Vignette A1.

Learning Objective: To understand the different types of ATS documents.

Primary Author: Michael Gould, MD, MS

An ATS member wants to lead a project that will result in an official ATS document that makes recommendations for diagnostic testing in patients with suspected pulmonary embolism. The member plans to assemble a multidisciplinary panel of experts, hold at least one face-to-face meeting and periodic conference calls, perform a comprehensive literature review, and use GRADE methodology to assess the quality of evidence, formulate recommendations, and judge their strength.

What type of ATS document is the most appropriate end-product of this project?

A.  Workshop report
B.  Conference proceeding
C.  Health technology assessment
D.  Clinical practice guideline
E.  ATS statement

Best answer: D

ATS guidelines make recommendations for clinical practice based on a systematic review of the literature, and use GRADE methodology to rate the quality of evidence, formulate recommendations, and assess their strength.  Systematic literature review is also required for health technology assessments.  Systematic literature review and use of GRADE are optional for other ATS document types.  All ATS documents are required to include an explicit and transparent description of methods used to assemble the panel, review and synthesize the evidence from the literature, and generate recommendations.  (GATS pages 3 and 5; Documents Table)

Note: all references to the American Thoracic Society Guidelines Packet (GATS) are to current version (Spring 2010).  All references to the Documents Table are to Table 1 on page 6 of GATS.


Vignette A2.

Learning Objective: To understand criteria used to assemble a committee of document developers.

Primary Author: Gerard Turino, MD

Documents prepared for the American Thoracic Society begin with the identification of a project such as a statement, a guideline, or a live conference or workshop by an individual or a group of individuals who see its necessity to advance the field. A Project Committee is then formed to execute the project. Which factors should be considered when selecting members of such a committee?

A.  Conflict of Interest in the field of study
B.  Willingness to take responsibility for the outcome of the project
C.  Reliability in meeting deadlines
D.  A record of expertise in the field and or required methodology
E.  All of the above

Best answer: E

Choices A-D all describe desirable characteristics of committee members.  It is important to assemble a panel that has the required level of expertise, making sure that a variety of perspectives and viewpoints is represented.  While all conflicts of interest must be disclosed and some require ongoing monitoring and management by the Ethics and Conflict of Interest Committee, having a conflict does not necessarily exclude ATS members from participating in the development of documents.


Vignette A3.

Learning Objective: To describe the process for developing a project proposal for an ATS-sponsored document.

Primary Author:  Marianna Sockrider, MD, DrPH

A group of ATS members put on a successful symposium at the International Conference providing an update on the management of acute respiratory distress syndrome.  The feedback from attendees was very favorable and led them to the idea of developing a clinical practice guideline on this topic.  They discussed this idea briefly after the session and identified two project team leaders and a list of candidates for a formal working group.  They recognized the need to get funding for this effort and official approval from the ATS to proceed.

After defining the goal of the proposed guideline and learning objectives, the project leaders’ next step should be to:

A.  Contact a primary ATS assembly or committee to sponsor the project application.
B.   Put together a budget request to submit to the ATS Program and Budget Committee.
C.   Invite other relevant societies or organizations to partner with ATS on the project.
D.   Send notice of the project’s inception to the ATS Documents Committee chair.
E.   Approach relevant industry contacts to sponsor a planning meeting for the group.

Best answer:  A

Although ideas for projects come from the membership at large, ideally all projects should be sponsored by an assembly or committee, and sponsorship should be established prior to submitting the proposal.  Because sponsored projects have a “seal of approval”, they are more likely to receive funding. Other choices describe required (budget request, notification of Documents Committee Chair) or optional (co-sponsorship by other societies or industry) steps that take place later in the development process.


Vignette A4.

Learning Objective: To describe the process for submitting a project proposal for an ATS-sponsored document.

Primary Author:  Marianna Sockrider, MD, DrPH

Members of the ATS Clinical Problems Assembly begin planning a technology review of interventional bronchoscopy to define standards for use in clinical practice.  A working group was identified and the Assembly’s Planning Committee endorsed the project.  The working group leaders set up a conference call with participants in order to complete a project application for submission to the ATS for funding.

Which of the following tasks must be completed prior to submission of this ATS project application?

A.  Conflict of interest statements must be completed by all potential team members
B.  An ATS staff member must be assigned to facilitate the review process.
C.  The Project Chair must sign an affidavit affirming support for the project in relation to the Assembly’s mission statement.
D.  A timeline must be created for the project’s first year linking goals to key milestones.
E.  A release to use proprietary information from bronchoscope manufacturers must be obtained.

Best answer:  D

The project application includes a description of the project and its goals, a list of panel members, a timeline for completion and conflict of interest (COI) disclosure statements from the chair and co-chair.  Panel members submit COI disclosure statements after the project has been approved.


Vignette A5.

Learning Objective: To describe the review process for ATS documents, including issues related to peer review, Board review and necessary timelines.

Primary Author: Maureen George, PhD, RN, AE-C

Document manuscript drafts that are ready for review are submitted online via Manuscript Central for subsequent review by outside peer-reviewers and the ATS Documents Editor. To facilitate the peer review process, documents should be submitted 4 months prior to a regularly scheduled meeting of the Board of Directors.

Which of the following is the most important reason for this procedure?

A.  This allows adequate time for the printer to apply the ATS lay-out template to the document.
B.  This timeline allows all Conflict of Interest (COI) forms to be submitted and evaluated.
C.  This is the time needed to perform copy editing, such as grammar and reference checks.
D.  Four months allows time for peer review, Board Subcommittee review, Documents Editor review, document revision and Board vote.
E.  This allows adequate time for Project Chairs to review GATS

Best answer:  D

Correct answer can be found on page 10 of the GATS


Vignette A6.

Learning Objective: To describe the review process for ATS documents, including issues related to peer review, Board review and necessary timelines.

Primary Author: Maureen George, PhD, RN, AE-C

To initiate the official documents peer review process, a cover letter must be submitted via Manuscript Central stating that you: are requesting official peer review, have obtained sign-off from all members of the development committee, have attached COI forms for each committee member, have checked the document for style, and will take responsibility for proofing. Which other items must be submitted at this time?

A.  A copy of each reference source cited in the document with the appropriate areas highlighted.
B.  A copy of each contributing members’ curriculum vitae to demonstrate their expertise in the area.
C.  A copy of the document minus tables and figures which will be reviewed through a separate process.
D.  Information as to what contributions were made by each author and their percent effort on this project.
E.  An electronic copy of the document, including all figures and tables

Best answer:  E

Correct answer can be found in memorandum from ATS Documents Editor, Holger Schunemann, and ATS Documents Director, Judy Corn, dated 10/16/09. 

 

 

Last reviewed: February 2015