Policy Committee Meeting 9_28_2023

OMA 2023

OMA Policy Committee Meeting Book

September 28, 2023 CONTENT CONFIDENTIAL - DO NOT SHARE CONTENT OUTSIDE OMA

Policy Committee Meeting September 28, 2023 4:00-5:00 PM EDT

Zoom Information: https://obesitymedicine org.zoom.us/j/89794174344?pwd=Ui8wNEJuamE2eTFBRHBMOTZkbHhnQT09

Meeting ID: 897 9417 4344 Passcode: 143159 719-359-4580, 89794174344# US

Presiding Officer: Dr. Ethan Lazarus

Time

Topic

Lead

Action

4:00 PM

Call to Order & Opening Remarks

Lazarus

4:05-4:55 PM Summarize the Review of Other Societal Policies/Practices regarding Position Statement/Policy Proposal Development with the following considerations:

Lazarus, All

Discussion

1) Should this policy just address Position Statements, or Clinical Practice Statements (CPS’) as well? 2) Who initiates these? The OMA President versus a motion by a member of the OMA BOT? 3) Is there a separate pathway for submission in Obesity Pillars journal versus publication on the OMA website? 4) Do we need an option for a standard pathway versus an urgent pathway for the development of such statements?

5) How are authors selected?

6) When is the document(s) sent to the EIC of Obesity Pillars ?

7) Approval of statements; should these be conducted via an in-person meeting or via E-mail? May want to consider E-mail for urgent statements, but in-person meetings for standard statements. 8) Sunsetting documents--how does this apply to position statements? Is there a process to review/revise these documents versus those published on the OMA website? (which are currently sunset after five years, unless renewed by the BOT) 9) Are there other questions raised by Policy Committee that need to be addressed?

5:00 PM

Call to Adjourn, Closing Remarks, and Next Steps

Lazarus

Policy/Procedure Analysis re: Development and Publication of Position Statements Among Medical Societies/Associations

Date: 07/21/2023 Prepared by: Teresa Fraker Background:

Dr. Ethan Lazarus, Immediate Past President of the OMA and Chair of the OMA’s Policy Committee convened the Policy Committee in 7/2023 for discussion surrounding the current processes by which the OMA currently utilizes for the development and dissemination of its various position statements in the OMA’s scholarly journal, Obesity Pillars . The current process that the OMA follows for such publications as position statements and proposals is enumerated by the Editor-in-Chief of Obesity Pillars as outlined below: • Suggestions of potential Position Statement topics can occur from any OMA Board of Trustee (BOT) member who in turn, can suggest ideas based upon discussions of OMA members. • The choice of topics for OMA Position Statements that move forward occurs via a discussion between the OMA President and the Editor-in-Chief of Obesity Pillars. • Authorship of OMA Position Statements is determined by the OMA President (who has likewise been tasked with selecting OMA Task Force members), based upon inviting authors with known expertise or interest in the topic, past willingness to work within a team approach, and a past record of timely completion of authorship tasks. Additionally, BOT members can also volunteer. • Obesity Pillars is allotted a finite number of free slots per year for OMA Position Statements and other Announcements. The number of slots per year is determined by Elsevier (the publisher). The topics for these limited number of potential OMA Position Statements is determined by the OMA President and the Editor in Chief of Obesity Pillars . If there is no room in the journal, the position statement will reside on the website and an email to membership can be sent. • Once the authors have completed an initial draft of an OMA Position Statement, it is then sent to the OMA BOT members via email for their review, comment, and suggested edits with a review time no less than one week. • If no OMA BOT member objects to the OMA Position Statement via email correspondence, then the OMA Position Statement can move forward toward publication without a formal OMA BOT meeting. • If any OMA BOT member objects to the OMA Position Statement via email correspondence, then a formal OMA BOT meeting will be required to discuss the Position Statement. If during this BOT meeting, the OMA Position Statement is approved by a majority vote, then the Position Statement will move forward toward publication. If during the BOT meeting, the OMA Position Statement does not receive a majority vote, then the Position Statement will not move forward toward publication with the potential for further edits and potential re-evaluation by the OMA BOT at a later date. • The final wording of the Position Statement publishing proofs are the responsibility of the authors of the Position Statement(s). Upon the request of the Policy Committee, select societies/associations were contacted in order to identify their “best practices” surrounding publications of their various position statements, clinical practice statements, clinical practice guidelines, etc. Of note, not all societies/associations use the exact same verbiage as the OMA does as it relates to these various processes and procedures. For example, one society/association may refer to their publication as Clinical Practice Statements versus Position Statements, when at first glance, the documents may read as one in the same.

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The following societies/associations were contacted to conduct this research, and their associated documentation/materials have been collected for further review and analysis as the Policy Committee or OMA BOT may desire. American Urogynecologic Society (AUGS) https://www.augs.org/

American Society for Metabolic and Bariatric Surgery (ASMBS) https://asmbs.org/ American Society of Breast Surgeons (ASBrS) https://www.breastsurgeons.org/ The Endocrine Society https://www.endocrine.org/ The American Society for Colon and Rectal Surgeons https://fascrs.org/

Summary: At a high level, most of these societies/associations outline a multi-layered, multidisciplinary review process before publication with a timeline of anywhere from 6 to 12 months (and potentially longer if felt to be warranted by the various review committees or processes) .

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ROUGH DRAFT – FOR REVIEW PURPOSES ONLY

5/18/2023:

For consideration at our next in-person board meeting:

Motion: I motion that the OMA adopt procedures around developing and disseminating position statements as outlined below. --------------------------------------------------------

Background: our amazing new Obesity Pillars journal represents a great way to disseminate position statements by the OMA BOT; however, it is important that position statements represent the fully considered input from the entire BOT, and not just a subset of the board. I’m concerned that our new process does not allow for comprehensive input and consideration from the entire BOT. For reference, historically, our board would request a position statement in a motion. Generally, that would be referred to a committee such as the policy committee, or sometimes to volunteer member(s) of the BOT. The draft resolution would be brought back to the board at an in-person meeting for discussion. Only after full discussion would the position be released publicly on the OMA website. And, it would be dated, and flagged for reconsideration or retirement at a 5 year sunset date. Our last 2 position statements were written by a subset of the BOT, submitted directly to the editorial staff of the journal, circulated to the BOT with limited time for consideration, it was recommended only minimal input be considered as it was already in final draft, and then were sent directly for publication to the entire world for perpetuity without a board discussion. Further, authors retained final say on the documents published, not the BOT Position statements from the Board need to represent the full consideration of the BOT, and should not be driven only by a subset of the board, nor by editorial deadlines. The 2 position statements we have published represent bold statements by our organization. The first, on compounded peptides, represented significant legal risk to our organization in the original version, fortunately mitigated by Jim Wilson. The second makes statements about a standard of care in obesity medicine. For 10 years on our BOT, our board has always voted against any statement regarding standard of care. This statement was outside the scope of our board motion – to create a document about comprehensive care. While the final version watered it down, it still states that pharmacotherapy for obesity represents the current standard of care. Again, while I personally would like this to be true, it is not currently true. In the past we avoided making statements like this for fear of alienating members who did not include pharmacotherapy as part of their treatment.

Further, we are currently pursuing a multi-organization standard of care publication – there was no need for the comprehensive care position statement to move into the realm of standard of care. This statement should not have been up to the authors – it should have been up to the BOT. I feel the current process does not allow for full consideration and discussion by the board for position statements which can now live in perpetuity with no sunset date. To make sure that the entire board has a full opportunity to participate in the development of position statements prior to publication, I suggest the following process be implemented: -------------------------------------------------------------------------------- Process: 1) A motion is passed calling on our OMA BOT to develop a position statement. a. Part of that motion will designate where this position is to be published – Obesity Pillars, on the OMA web site, sent in an e-newsletter, etc. 2) All members of the OMA that wish to participate may write an initial draft of the statement. a. Alternatively, it can be referred to a committee of the OMA – historically the policy committee was asked to write and review position statements. 3) The initial draft is circulated to the entirety of the OMA BOT for full comments and edits. The board is given a minimum of 2 weeks to reply. 4) A second draft is sent to the entire OMA board. 5) Unless the matter is urgent, the position statement is discussed at a live meeting of the BOT so all board members can participate. 6) If the statement is intended for the Pillars journal, then at this point it will be sent to the Pillars editorial board. a. At this point, the article proceeds via the standard editorial process. 7) Because these statements represent the position of the full BOT, all OMA trustees are included as authors, unless they do not wish to be listed, with the main author(s) prioritized per standard journal procedures. 8) Because positions of the organization can change from time to time, even if published in journals, position statements should include a sunset date (5 years). At that time, they should be reconsidered, and either retired, amended, republished, etc. They should become part of the policy that policy committee reviews on an annual basis.

Respectfully submitted by Ethan Lazarus, MD

Clinical Issues Committee Development

SELECTION OF STATEMENT TOPICS 1. Clinical Issues Committee (CIC) receives topics for statement development from one of the following four sources: A. ASMBS committee chairs as a result of a “Call for Statements” issued annually. B. ASMBS Membership regarding topics they view important via “Call for Statements” issued annually. C. Executive Council (EC): • EC may issue a directive to the CIC for a particular statement(s) to be drafted. • EC may charge another ASMBS committee with developing a draft. D. Within the CIC itself. * Once the responses are received from the “Call for Statements”, the recommended topics are to be reviewed by the EC for the purpose of prioritizing and issuing the directive to the CIC chair for the statements to be developed, recognizing that some may be assigned to a committee outside the CIC. Note: See “Statement Development (Non-CIC Committee) for all statements that originate from and are finalized by a committee other than the CIC. 2. Statement topic is assigned to one of the following two groups for development of draft: A. CIC may charge a subcommittee (within the CIC) to write the initial draft of statement. B. CIC may assign it to another ASMBS committee; if so, see “Statement Development (Non-CIC Committee) . Note: If there are numerous statements in the queue, the CIC will request prioritization of the statement topics by the Executive Council. Timeline: Three months for draft of statement to be written once it is assigned. STATEMENT DEVELOPMENT PROCESS BEGINS 1. Subcommittee of the CIC Develops Statement Draft  • Draft is submitted to the entire CIC for their review and comments. o CIC subcommittee reviews and addresses all reviewer comments.  If major changes are required, then the new draft is sent back to CIC for review. OR

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Clinical Issues Committee Development

o CIC committee approves draft as written. 2. Once statement draft is approved by Clinical Issues Committee  • Draft sent to Executive Committee of the Executive Council (ECEC) for review and comment . o ECEC (and reviewing committee, if utilized) may approve statement draft as written o ECEC may determine draft needs to be sent to another committee for simultaneous review and comment. o ECEC and/or reviewing committee may have recommendations, and draft is sent back to CIC Chair to address recommended edits.  The above steps may occur multiple times until final draft is approved by ECEC and reviewing committee. 3. Once approval is obtained from the ECEC  • Draft is sent to the EC for review and comments. o EC (and reviewing committee, if utilized) may approve statement as written. o If relevant (and not done previously), EC may determine draft needs to be sent to another committee for simultaneous review and comment. o If EC and/or reviewing committee has recommendations, then draft is sent back to CIC Chair to incorporate recommended edits.  The above steps may occur multiple times until final draft is approved by EC and reviewing committee. o If advised by EC: Draft is sent to ASMBS legal advisor for comment. o Draft is then sent back to CIC Chair to incorporate legal advisor’s recommendations. 4. Once approval is obtained from the EC  • Statement goes out to the entire ASMBS Membership for comment via email by the ASMBS Communications Manager. Membership is given two weeks to comment. All member comments are collected by the CIC Staff Liaison during this 2-week period. • After close of member comments, CIC Staff Liaison sends member comments back to CIC Chair and lead author for review of member comments and incorporating of appropriate edits. Track Changes MUST be used . 6. Once membership comments have been incorporated 

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Clinical Issues Committee Development

• Statement is sent to ECEC for review and comments (NOTE: It MUST be sent to the ECEC in Tracked Changes version ). o If ECEC has further recommendations, statement is sent back to CIC to incorporate recommended edits.  The above steps may occur multiple times until final draft is approved by ECEC and CIC. 7. Once final approval is obtained from the ECEC  • Statement returns to EC for review and comments (NOTE: It MUST be sent to the EC in Tracked Changes ). o If EC has further recommendations, statement is sent back to CIC Chair to incorporate recommended edits.  The above steps may occur multiple times until final statement is approved by the EC and CIC. 8. Once final approval is obtained from the EC  • Statement is ready for publication: o CIC Chair or Lead Writer submits to SOARD via the SOARD online management system.  Lead Writer alerts CIC Chair if they submit to SOARD. o CIC Chair sends either the “SOARD Review Submission” (for Literature Reviews) or “SOARD Statement Submission” cover letter via email to SOARD Editor-in Chief. The ASMBS President and ASMBS Staff Liaison are copied on the email. o Once statement is deemed to be in publication the ASMBS CIC Staff Liaison publishes on: 1. ASMBS website (under the “ ASMBS Professional Resource Center: Position and Consensus Statements ” 2. “Top 5 on the 5 th ” Electronic Newsletter (ASMBS Staff Liaison sends to ASMBS Communications Manager) 9. All statements, once developed, will be reviewed annually by the CIC for the purpose of determining if, and when, the statement(s) needs revising. • For all statements requiring revision, please see the “CIC Review of Existing Statements”.

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ASMBS Statement Development Process for Clinical Issues Committee

Call for Statements

EC recommends final TOPICS

Form CIC subcommittees

Generate TOPIC list

CIC Chair review

CIC Subcommittee develops draft statement

CIC Chair review

Copyedit review

CIC members review draft

ECEC review

Legal advisor review (If Necessary)

CIC Chair review

SUBMIT to SOARD

CIC Subcommittee

EC final review

ECEC review

EC Review

ASMBS Membership review and comments

ECEC

CIC Chair review

ASMBS Surgeon CIC Writing Group Timeline • First 1-2 weeks: o Formulate outline with team

o Assign focused roles/writing assignments o Send to Chair for review o Kara Kallies is available to assist with review of the literature • June/July: o Produce working draft that was circulated internally for editing o Send to Eisenberg for review • Aug/Sept: o Final edits o Submit to CIC Membership for comment • Nov/Dec: o Incorporate Membership edits o Submit to Legal if needed o Final version to EC • Team Leader Roles:

o Finalize outline and assign writing assignments o Check up on progress of writing on regular basis o Determine order of authors on manuscript

Publication Policy and Development Process

Publication Policy This document represents American Urogynecologic Society’s (AUGS’) overarching policy on the development and public dissemination of publications commissioned and/or created by society members on behalf of AUGS. The principles expressed are general by intent and provide for some flexibility. By way of definition, a Publication is any document (Guideline, Policy Statement, Editorial, Best Practice Statement, Joint or Consensus Statements, Systematic Review, Manuscript, etc.) developed by an AUGS taskforce, committee, network, registry or the PFD Research Foundation for publication or public dissemination. Publications generated through an AUGS-sponsored (supported) or AUGS organized volunteer structure are to be published on the AUGS Website and/or in FPMRS , the official journal of AUGS. Alternative journals or periodicals may be considered depending on the intended audience, but require approval by the Board prior to submission. All Publications must be reviewed and approved in their final form by the Board of Directors prior to submission for publication. Because acknowledgment may imply endorsement by acknowledged individuals, AUGS will require that all members of the writing group and related Committee complete a contributor agreement. It is the responsibility of AUGS staff to collate a list of contributors to a Publication and document their approval to be acknowledged in the Publication. chaired by the Guidelines Committee Chair. The process must include the following steps: 1) development by experts on the topic, 2) peer review by members outside the writing group, 3) legal review and 4) Board approval. Authorship on these documents will be based on the type of document that is being developed: • Policy Statements – issued by the Board • Position Statements – approved (issued) by the Board • Best Practice Statement or Guideline – individuals contributing to the document may be listed • Systematic Review or Manuscript – individuals contributing to the document will be acknowledged as the authors • Joint or Consensus Statements – acknowledgement will be determined at the onset by the AUGS board and the partnering organizations. Research Network and Registry Project Manuscripts – AUGS-funded research network and registry manuscripts will follow their own process for development and finalization. This process will be consistent amongst all networks and registries and must include a review outside of the writing group and Board approval of the final version. Authorship on these documents will follow the ICMJE guidelines for authorship and those of the journal. Statements and Guidelines – These documents will follow a process for development and finalization as approved by the Board. This process will be administrated and coordinated by AUGS staff and will be

Document Development Process AUGS develops various documents throughout the year and every document or publication developed by an AUGS Committee or Network should follow the same general process. The following appendices detail document types, outline the general process for document development and general expectations of work group members as well as the external review and approval process. The Executive Director should be consulted if a group is proposing changes to this development process.

The basic process should include: 1. Topic Identification 2. Writing Group Identification 3. Literature/Research Review 4. Data Acquisition 5. Document Writing 6. Peer Review 7. Approval 8. Dissemination

Additional details pertaining to the Document Development Process are contained below.

AUGS Document Types Overview: Throughout the year the AUGS Board of Directors requests that its committees develop appropriate clinical documents to guide the work of physicians and allied health care professionals who treat women with pelvic floor disorders. Below outlines the types of documents that can be developed. The AUGS Board of Directors must approve all documents prior to publication. From time-to-time AUGS may decide to partner with another medical society/ organization on a topic for joint publication. Before entering into a formal partnership, these statements must be approved by either the AUGS Board or the Executive Committee. Document Types • Clinical Practice Guidelines – a statement that includes recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. AUGS clinical practice guidelines should be based on a systematic evidence review, developed by panel of multidisciplinary experts and provide a clear explanation of the logical relationships between alternative care options and health outcomes. • Best Practice Statement - a statement that utilizes the literature and expert opinion on a specific issue • Consensus Statement – a document that reflects the collective opinion of leaders in the field on a specific topic • Policy Statement – a document on an emerging or timely issue relevant to the field of Female Pelvic Medicine and Reconstructive Surgery • Systematic Review – a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question. • Manuscript – any article submitted to a peer reviewed publication of original research findings or a description of a Society-developed initiative. Document Confidentiality All documents are considered confidential until published. Documents should not be shared outside those specified in the document development process. All documents in development will include a Confidential watermark and footnote that states “This document is not to be shared or viewed outside the designated Committee or Board of Directors without written permission from the AUGS Executive Director.”

Document Review and Approval Prior to Publication Requirements

Terminology Committee Review

Peer review (FPMRS)

Internal Peer Review

Writing Group

Public Comment

Legal review

BOD review and approval

Guidelines, Best Practice, Consensus Statements Policy Statements

X

X

X

X

X

X

X

X

X

X

X

X

Systematic Review

X

X

X

X

X

Manuscripts*

X

X

X

X

X

*Originating from, but not limited to, AUGS Committees, PFDR, AQUIRE, Research Network, PFD Research Foundation Board

Document Structure and Development Overview Clinical Practice Guidelines Best Practice Statement Policy Statement

Systematic Review

Consensus Statement

Literature review on a research question that synthesizes research evidence A literature review of available literature

Evidence-based guidance which reflects the principles of the FPMRS profession Literature is reviewed; no data anlaysis performed Committee/work group members contribute knowledge and experience to form recommendations A systematic review doesn’t exist, but topic is of importance to the field Consensus is based on literature review and expert involvement

Evidence-based guidance with a specific clinical scope and purpose Systematic review or comparable data analysis Committee/work group members review the literature to determine data to be extracted Developed once a systematic review is done on a relevant topic

A straightforward statement on a specific topic

Collective opinion of an expert group/panel

definitions

A literature review limited to key references

Opinions with relevent references

evidence

Source of

Not applicable

Developed by experts on the specific topic

Developed by a group/panel of experts on a specific topic

Expert opinion

Statement needs to be made on a specific topic (less clinically relevant and more policy focused)

Development of a Clinical Practice Guideline or at minimium a Best Practice Statement

Limited data is available, however topic is timely and relevant

Purpose

Systematic review, data extraction, meta-analysis

Literature review, PICO, evidence grading, conclusion

Consensus either formal or informal

Process

20 – 30 pages Approx. 8,000 words

1 – 2 pages Approx. 2,000 words

Up to 20 pages Approx. 6,000 words

2- 5 pages Approx. 4,000 words

Length

Note: Original manuscripts follow the established journal requirements.

General Document Development Process The following outlines the general process for development of a document (such as systematic review, manuscript, or Editorial) by an AUGS Committee, Network or Board Member. The Executive Director should be consulted if a group is proposing changes to this development process. 1. Topic Nomination – All topic nominations must be approved by the AUGS Board of Directors prior to any work being started on a document. 2. Writing Group Identification – Once a topic and document type is approved for development a writing group and chair are identified. The writing group can be an internal group to the committee, an external group to the committee or a hybrid approach. All writing group members will disclose any conflicts as outline by the COI Policy. Appendix A: Writing Group Expectations and Responsibilities; Appendix B: Contributor Agreement 3. Document Writing – A designated chair of the writing group is expected to work with staff to create a timeline for development, make assignments for writing, collate the assigned sections to ensure a cohesive writing style is followed, check for appropriate grammar usage and that citations are complete. Expectations of authorship will be reviewed by the Writing Group Chair at the start of the document writing process and will follow those guidelines established by the peer reviewed journal. Any questions concerning authorship decisions will be managed by the Writing Group Chair. 4. Peer Review – The draft document is reviewed by a minimum of 3 individuals who are not on the writing group, but are members of the AUGS Committee. This is intended to be an internal peer review process separate from the peer review process which will occur at the Journal level. Appendix C: Peer Review Expectations/Checklist 5. Approval and Publication – Once the document is approved by its originating Committee, Network or Registry it should be submitted to the Terminology Committee to ensure consistency of terminology, use of good grammar, reliance on appropriate evidence to support statements, etc. Board approval is required prior to submission for publication. 6. Dissemination – All documents are published in the journal, Female Pelvic Medicine and Reconstructive Surgery and should be submitted via the standard manuscript submission process. AUGS staff will assist with the submission of these documents. Each document will also undergo the peer review process as established by the Journal. Additional distribution may be considered for the urogynecology community and the general public through webinars, patient fact sheets, quality measures and educational products.

Guidelines and Statements Development Process The following outlines the document development process by the AUGS Guidelines Committee. The Executive Director should be consulted if the Guidelines Committee is proposing changes to this development process. 1. Topic Nomination – Topics for Guidelines or Statements can be nominated by members of the Guidelines Committee, as well as other AUGS Committees, the AUGS Board or AUGS members. The Guidelines Committee is responsible for determining what type of document will be developed, as well as the timeline for the development of the document. Once this has been determined, a proposal (including writing group chair recommendations) is sent to the AUGS Board of Directors for their approval. All topics must be approved by the AUGS Board prior to starting the topic development process. Appendix E: Guidelines Committee Roles and Responsibilities; Appendix F: Contributor Agreement (Committee-level) 2. Writing Group Identification – Once a topic and document type is approved for development a writing group chair is appointed by the AUGS President. The chair is selected based on his/her expertise in the topic area, ability to work in a team, and experience in methodology. The chair must not have any relevant Conflicts of Interest (COI) with the guideline or statement under consideration. The Writing Group Chair will work with the Guidelines Committee Chair to identify 3 to 5 additional members to serve on the topic work group. These members should also have expertise in the topic area, as well as be strong writers and editors. COI of work group members will be managed by the Chair. Appendix A: Writing Group Expectations and Responsibilities; Appendix B: Contributor Agreement 3. Expectations of Acknowledgement – Contributors may be listed on select documents. Expectations of acknowledgement will be reviewed by the Writing Group Chair at the start of the document writing process and will follow those guidelines established in the AUGS Document Development Policy and Process. Any questions concerning acknowledgement decisions will be managed by the Writing Group Chair. At the discretion of the Board, the standard acknowledgement may be waived. Appendix D: Writing Group Acknowledgement 4. Literature Review – The Writing Group, with assistance from a methodologist as needed, selects/identifies articles with pertinent data to support the document development process. An initial literature search is conducted by an AUGS Staff member, with support from the Guidelines Committee and topic work group as needed. 5. Data Acquisition – Relevant data is extracted; analyzed; meta-analyzed, when appropriate; and synthesized by the methodologist as needed. The findings are presented to the Work Group in an evidence report. 6. Document Writing – The Writing Group creates a draft document by writing the text that supports what was found from the literature search. The Writing Group is responsible for ensuring a quality document is produced. They are encouraged to utilize other members of the Guidelines Committee to assist in the editing process. 7. Peer Review – The draft document will follow the peer review process as developed in collaboration with the FPMRS Editor. Appendix C: Peer Review Expectations/Checklist 8. Peer Review – The draft document is reviewed by a minimum of 3 individuals who are not on the writing group, but are members of the AUGS Guidelines Committee. This is intended to be an internal peer review process separate from the peer review process which will occur at the Journal level. A document may also be made available for public comment through the AUGS website. The writing group is responsible for addressing all comments and preparing a final version for the Guidelines Committee. Appendix C: Peer Review Expectations/Checklist 9. Guideline Approval and Publication – Once the document is approved by the Guidelines Committee, it goes to the Terminology Committee to ensure consistency of terminology, use of good grammar, reliance on appropriate evidence to support statements, etc. The final document is reviewed by legal, approved by the Board of Directors and then officially published on the AUGS website. Appendix C: Peer Review Expectations/Checklist 10. Dissemination – All documents are published in the journal, Female Pelvic Medicine and Reconstructive Surgery and should be submitted via the standard manuscript submission process. AUGS staff will assist with the submission of these documents. Each document will also undergo the peer review process as established by the Journal. Additional distribution may be considered for the urogynecology community and the general public through webinars, patient fact sheets, quality measures and educational products.

Appendix A: Writing Group Expectations and Responsibilities 1. An AUGS Staff liaison is responsible for managing the document develop process for the Committee, Writing Group, Network, Registry, etc. This is done to ensure consistency from group to group, as well as to alleviate the administrative workload from the volunteers. Staff liaison responsibilities will include the following (not an exhaustive list) a. Manage the document development process b. Scheduling work group calls c. Maintaining meeting minutes in collaboration with work group chair d. Sending assignments and reminders of deadlines e. Collate COI, disclosures, permission for acknowledgment at start of work group project and prior to document publication f. Ensure that a peer review process is followed and expectations are clearly set with all peer reviewers g. Develop a list of candidates to serve as peer reviewers; manage the selection and appointment of peer reviews and ensure their reviews are conducted in a timely manner and all comments and suggestions are conveyed to the Writing Group Chair h. Formatting manuscript and references per journal rules 2. Writing Group Chair a. Distribution of writing assignment

b. Editing the components to ensure a uniform writing style c. Determine and manage the order of acknowledgements d. Collecting and responding to peer review comments and suggestions e. Provide updates and open communication with the Guidelines Committee Chair f. Set up expectations of the Writing Group at the start of each project 3. Writing Group Members a. Complete Contributor Agreement and Conflict of Interest Forms b. Complete tasks in a timely manner c. Participation on phone calls d. Timely response to emails and assigned tasks e. Find a replacement if you are unable to finish your assignment

Appendix B: Contributor-level Agreement Thank you for agreeing to work on [insert name of work] (“Work”) of the American Urogynecologic Society (“AUGS”) and for your contributions to the Work. In order to ensure that AUGS and any affiliated organizations and any employees, agents, licensees and assignees of AUGS will be able to fully utilize the Work, please complete this form, sign, date and return to: INSERT. With regard to the Work, you agree to the following: 1. You grant and assign to AUGS all worldwide right, title and interest in and to your contribution to the Work (collectively the “Contribution”), all rights in the Contribution provided by law, including but not limited to all revisions and/or derivatives thereto, including the copyright therein, in all languages and in all forms now known or later developed, including but not limited to electronic formats from which the Contribution can be perceived, reproduced, or otherwise communicated either directly or with aid of a machine or device for the full term of the copyright, and all renewals and extensions thereof throughout the world; all right, title and interest in and to the title of any portion of the Contribution, including without any limitation any trademarks, service marks and/or trade dress, and all goodwill associated therewith. 2. You waive any and all moral rights you have to or regarding the Contribution or the Work. 3. You warrant and represent that (a) you have full power and authority, free of any rights of any nature whatsoever by any person, to enter into this Agreement and to grant the rights which are granted to AUGS in this Agreement; (b) no part of the Contribution infringes upon any copyright or other intellectual property right of any third party; (c) the Contribution contains nothing libelous, injurious or untrue (d) you have, as necessary, obtained appropriate permission to re-print any portion of the Work which you are not the author. 4. You acknowledge that AUGS has no responsibility to provide legal counsel or other assistance with respect to any requests for information (including but not limited to any subpoenas) directed to you arising out of your contribution to the Work or publication of the Work. □ Yes □ No You grant to AUGS the right to use your name in connection with the publication of the Work and to acknowledge you as a contributor to the Work. In consideration of the rights granted to it pursuant to this Agreement, AUGS agrees to acknowledge you as a contributor, if you so designate above. Signature: ______________________________________ Name/Title: ______________________________________ Institution/Organization: ______________________________________ Signature/Date: ___________________________________

Appendix C: Peer Review Expectations/Checklist Document/Manuscript Title: Corresponding Author: Assigned Reviewer: Y/N

Suggestions to writing group

Does the TITLE accurately and concisely reflect the content of the manuscript? Does the TITLE accurately and concisely reflect the content of the manuscript? Are the objectives of the investigation clearly stated in the INTRODUCTION? Is proper terminology consistent with ICS/IUGA consensus papers utilized in the manuscript? Is the MATERIALS and METHODS section adequately detailed to allow reproduction of the study? Is patient follow-up adequately detailed? Are TABLES/FIGURES appropriately labeled and referenced in the manuscript? Have the results been appropriately interpreted in the DISCUSSION? Are the CONCLUSIONS supported by the data presented? Are the implications of the study implicitly stated? Have the authors stated the limitations of their study? Have the authors explained how this study contributes to the already published literature? Have you alerted the authors of any grammar, spelling, or structural errors in the manuscript?

Appendix D: Writing Group Acknowledgement The following process and guidance will be used to publicly recognize writing group/committee members who participated in the development of a document or manuscript: • The Committee is cited as the author for all documents. In some cases, authorship for a statement may include a listing of the work group members. • Individual contributor recognition will be established by the writing group chair in accord with the publications policy prior to commencement of work for the document. • All individuals involved in the development of a document or manuscript must sign a contributor agreement and COI disclosure form. • Everyone who has made substantial, direct, intellectual contributions to the work will be recognized. • All work group members should participate in writing the manuscript, reviewing drafts and approving the final version. • Membership on a committee, writing group, network, etc. alone does not justify authorship or acknowledgement. • Contributors will be recognized in a standardized format approved by FPMRS journal. Acknowledgement will occur as follows and will appear at the top of the article: o This document was developed by the American Urogynecologic Society (AUGS) Guidelines Committee with the assistance of [names of Writing Group members]. This peer-reviewed document reflects clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.  [Acknowledgement section to include] All Writing Group members disclosed commercial and financial relationships. Writing Group members who were found to have conflicts of interest based on the relationships disclosed did not participate in the final approval of this document. INSERT WRITING GROUP DISCLOSURES

Appendix E: Guidelines Committee Roles and Responsibilities The Guidelines Committee is charged with ensuring that the AUGS-approved Document Development Process is followed for each publication developed under the Guidelines Committee. The Committee oversees the document development process which includes: • Planning topics • Identifying and inviting Writing Group Chairs and members • Reviewing each completed paper before it is submitted for Board approval Committee members are required to participate in conference calls to plan publications, to review AUGS-branded papers, and may be asked to write a paper as well. All Committee members are required to have on file with AUGS staff a completed conflict of interest statement and Contributor Agreement. Any conflicts will be resolved through a process approved by the AUGS Board of Directors. The Guidelines Committee may collaborate with other Societies and Colleges (e.g. ACOG) in the development of joint statements/bulletins, as appropriate. In these cases, the Committee will identify one individual, from the committee, to serve as the liaison between AUGS and the partnering Society.

Appendix F: Contributor Agreement (Committee-level) Thank you for your past and future work on [insert name of committee] (“Committee”) of the American Urogynecologic Society (“AUGS”) and for your past and future contributions to the work of the Committee (the “Work”). In order to ensure that AUGS and any affiliated organizations and any employees, agents, licensees and assignees of AUGS will be able to fully utilize the work product of the Committee and the Work, please complete this form, sign, date and return to: INSERT. With regard to the work product of the Committee and the Work, you agree to the following: 1. You grant and assign to AUGS all worldwide right, title and interest in and to your work product for the Committee and your contribution to the Work (collectively the “Contribution”), all rights in the Contribution provided by law, including but not limited to all revisions and/or derivatives thereto, including the copyright therein, in all languages and in all forms now known or later developed, including but not limited to electronic formats from which the Contribution can be perceived, reproduced, or otherwise communicated either directly or with aid of a machine or device for the full term of the copyright, and all renewals and extensions thereof throughout the world; all right, title and interest in and to the title of any portion of the Contribution, including without any limitation any trademarks, service marks and/or trade dress, and all goodwill associated therewith. 2. You waive any and all moral rights you have to or regarding the Contribution or the Work. 3. You warrant and represent that (a) you have full power and authority, free of any rights of any nature whatsoever by any person, to enter into this Agreement and to grant the rights which are granted to AUGS in this Agreement; (b) no part of the Contribution infringes upon any copyright or other intellectual property right of any third party; (c) the Contribution contains nothing libelous, injurious or untrue (d) you have, as necessary, obtained appropriate permission to re-print any portion of the Work which you are not the author. 4. You acknowledge that AUGS has no responsibility to provide legal counsel or other assistance with respect to any requests for information (including but not limited to any subpoenas) directed to you arising out of your work on the Committee or publication of the Work. □ Yes □ No You grant to AUGS the right to use your name in connection with the publication of the Work and to acknowledge you as a contributor to the Work. In consideration of the rights granted to it pursuant to this Agreement, AUGS agrees to acknowledge you as a contributor, if you so designate above. Signature: ______________________________________ Name/Title: ______________________________________ Institution/Organization: ______________________________________ Email: ______________________________________ Signature/Date: ___________________________________

American Society for Breast Surgeons (ASBrS) Benign Breast Disease Pathways Methods 07/12/2023

Protocol • Steering Group completes top level protocol information to guide full pathway. Example protocol fields are below: Pathways Scope Surgical management of a) Atypias/high risk lesions; b) Benign fibroepithelial lesions; c) Infectious/inflammatory lesions; d) Other benign lesions Pathway Audience General and subspecialist surgeons, APPs, OB/GYN, primary care providers (internal medicine/family practice), trainees 1. Overarching Pathway Question a. What is the appropriate initial management of people with newly diagnosed benign breast disease?

i. What surgical techniques should be used based on clinical or patient characteristics? ii. What is the appropriate short-term follow-up of patients with benign breast disease?

2. Overarching Inclusion Criteria (criteria that would apply to all research questions) Per specific pathway-patients (male and female) with benign breast disease 3. Overarching Exclusion Criteria (criteria that would apply to all research questions) Evaluation of benign breast disease; Long-term follow-up (e.g., chemoprevention) Special populations: • Males with breast masses/nipple discharge

• Pregnant women • Lactating women • Young women

Method Overview The overall Pathway development process is summarized in Figure 1, and described below.

Steering Group (SG) and experts: Draft recommendations and supporting evidence

Consensus Panel (CP): Rating round 1 (via email) •SC: Rating round 1 scored and summarized

CP: Consensus meeting, dicussion of recommendations with uncertainty/ disagreement •CP: Rating round 2 •Rating round 2 scored and summarized

Pathway prepared for public comment

Public comments integrated into final pathway

Draft Recommendations for Each Pathway • After Board approval, Steering Group engages ~2-3 experts in each disease area who will actively contribute to development in that disease area, with SG and consultant oversight to promote consistency across the disease areas. These experts will not participate in the voting/rating process. Major pre-consensus tasks for the experts will be: a. Prepare disease-specific protocol form/research questions b. Conduct iterative reviews of literature review findings, until completion of evidence summaries c. Draft recommendations and supporting documentation intended for Consensus Panel review Consensus Process • After Board approval, SG and experts select and invite Consensus Panel members (~9-12) for each of the four BBD groupings. Consensus Panelists will be chosen to best reflect the diversity of the intended pathway audience, including members with varying specialties, geographic location, time in practice, and type of practice. • For each Consensus Panel, the following key steps will occur: a. Orientation. A virtual Consensus Panel orientation meeting provides an overview of the process, methods, and timeline. b. Rating Exercise. Consensus Panel members receive an email with the literature evidence summary and draft recommendations for each pathway. Panelists independently conduct ratings for each recommendation. c. Scoring. First round ratings are scored using predetermined criteria. Scoring documentation will capture median scores for each recommendation and whether ratings reflected disagreement. Recommendations will be categorized per the scoring criteria (see below). Summary scores will be returned to the Consensus Panel members via email, to prepare for the meeting (see Appendix 1). d. Consensus Panel meeting (in person or virtual). Review, discuss, edit each recommendation for which there was disagreement, and any others flagged. i. Consensus Panel members conduct a second round of ratings for all recommendations. e. Final scoring and summary.

Likert Scale Rating • For each recommendation, the panel will rate their agreement on a Likert scale of 1 to 5, where 1 means that the rater strongly agrees with the recommendation, and 5 means that the rater strongly disagrees with the recommendation. A middle rating of 3 indicates that the rater neither agrees nor disagrees (see Appendix 1). • Scoring: o Strong Consensus: If >90% of panelist rate a recommendation as either “strongly agree” or “agree” and the median score is 1, the recommendation is adopted. o This assumes that “strong agreement” on the Likert scale is scored as a 1. o Only “strongly agree” and “agree” are included in the percent agreement calculation. • Consensus: If > 75% and <90% of the respondents from the Consensus Group rate a recommendation as either “strongly agree” or “agree” and the median is either 2 or 1, the recommendation is adopted. • No Consensus: If consensus is not achieved following two rounds of ratings, then the Steering Committee may opt to leave a clinical question unanswered and state, “Consensus could not be achieved.” If multiple recommendations achieve consensus at a decision node, the Steering Group may engage the Consensus Panel in ranking the recommendations, if desired. Public Comment Pathways will be made publicly available for a 2-4 week public comment period. The SG and experts will review comments submitted, and: • Determine whether comments warrant changes to pathway recommendations. SG members can re-engage Consensus Panel members if desired to obtain rapid voting regarding whether changes should be made. • Prepare a summary document that can be published on the ASBrS website and/or submitted as an appendix to the manuscript. Pathways Development & Approval Final pathways will be developed including an algorithm that facilitates clinical decision support, and brief narrative summarizing the methods and evidence. The final document will be approved by the ASBrS Board prior to submission for publication.