IP Guideline Development Handbook — Part 3: Development Checklists, Author Roles & Inclusive Language

Appendix E: Development Checklists ¹

Timelines are subject to change based on topic complexity, publisher scheduling, or other factors.

32-Month Expert Guidance Checklist

22-Month Practice Statement Checklist

6-Month Consensus Statement Checklist

Appendix F: Review and Comment Period ¹

The following principles and procedures apply to the external review and comment period for documents produced under the sponsoring organization’s guideline development process.

1. The decision to endorse a guideline or guidance document is the decision of the organization that is considering the document.
2. Organizations reviewing a document sponsored by the professional society should indicate in the appropriate column on the review form any changes that are necessary for endorsement.
3. The draft provided during the review period includes:
   • a. A “DRAFT” watermark
   • b. A header with “not for distribution”
   • c. Clear section headers, sub-headers, and tertiary headers
   • d. Staff contact information
4. The standard comment form includes:
   • a. Official name (if the reviewer is an organization)
   • b. Reviewer’s name and email or organization’s name and email
   • c. An open field for submission of the header, sub-header, or tertiary header being addressed
   • d. An option for the organization to submit its endorsement decision

Review and Comment Period Actions

Appendix G: Writing Panels – Author Responsibilities ¹

The following table defines the roles and responsibilities for each position on a writing panel convened under the sponsoring organization’s guideline development process. It also specifies how each role is listed in the published manuscript.

First Author / Lead Author (Chair)

Responsibilities in detail:

• Lead calls and guide discussion over calls and email:
  • Respond to comments and questions from authors regarding the manuscript
  • Delegate responses to appropriate authors if unable to respond
  • Facilitate the consensus process among panel members for recommendations, in accordance with the organization’s process
• In collaboration with the staff liaison:
  • Draft manuscript proposal
  • Select panel participants (with input from leadership, as relevant)
  • Adhere to the appropriate development process(es)
  • Develop agenda for meetings and lead calls
• Commit to and support adherence by the panel to deadlines and milestones
• Commit to and adhere to the allocation of resources (staff, budget) as approved by the Board at the outset of the project
• Decide and communicate how steps will be accomplished among members of the panel (e.g., handoffs from one milestone to the next)
• Serve as primary author of the manuscript’s Introduction
• Thoroughly review the document for accuracy of content (staff will lead formatting decisions):
  • Upon combination of draft sections
  • Upon revisions following external review
  • Prior to submission for publication
  • Upon receipt of proofs
• Serve as spokesperson for media/PR, if pursued
• Review press release, if developed

Last Author / Senior Author (Possible Co-Chair)

Responsibilities in detail:

• Support and assist the first author in the areas described above
• Coordinate with first and second authors to assume or delegate responsibilities for reasonable burden among authors
• Determine with lead authors and staff how steps will be accomplished among members of the panel (e.g., handoffs from one milestone to the next)
• Contribute as author of the manuscript’s Introduction
• Commit to and support adherence by the panel to deadlines and important milestones for progress
• Commit to and adhere to the allocation of resources (staff, budget) as approved by the Board at the outset of the project
• Thoroughly review the document for accuracy of content:
  • Upon combination of draft sections
  • Upon revisions based on external review
  • Prior to submission to journal
  • Upon receipt of proofs
• Coordinate with second author regarding interim responsibilities if first author is not available
• Potentially participate as spokesperson for media/PR, if pursued

Second Author (Possible Co-Chair)

Responsibilities in detail:

• Support and assist the first author in the areas described above
• Coordinate with first and senior authors to assume or delegate responsibilities for reasonable burden among authors
• Contribute as author of the manuscript’s Introduction
• Commit to and support adherence by the panel to deadlines and milestones
• Commit to and adhere to the allocation of resources (staff, budget) as approved by the Board at the outset of the project
• Thoroughly review the document for accuracy of content:
  • Upon combination of draft sections
  • Upon revisions based on external review
  • Prior to submission to journal
  • Upon receipt of proofs
• Coordinate with senior author regarding interim responsibilities if first author is not available
• Potentially participate as spokesperson for media/PR, if pursued

Corresponding Author

Responsibilities in detail:

• Institution should have a read-and-publish agreement with Cambridge
• Complete required forms for the journal where the manuscript is accepted
• Report correspondence with the journal to the staff lead
• Thoroughly review proofs and share revisions with staff, fellow authors, and/or additional partners as appropriate
• Work with staff lead to submit, review, and approve proof revision(s)
• Respond to inquiries related to the manuscript’s content

Lead Authors (as a Group: First, Second, and Last/Senior)

Responsibilities in detail:

• Conflict resolution during abstract and full-text screenings (if relevant)
• Collaborative leadership decision-making
• Commitment to and support for adherence by the panel to deadlines and milestones

Subgroup Lead(s)

Responsibilities in detail:

• Schedule and lead subgroup meetings during the writing phase (the organization can provide a Zoom link if needed)
• Solicit updates on subgroup members’ progress
• Commit to and support adherence by the subgroup to deadlines and milestones
• Raise issues with staff or lead authors as needed

Panel Members (Usually the Authors)

Responsibilities in detail:

Complete, as assigned and relevant to the manuscript:

• Abstract review
• Full text review
• Article extraction
• Manuscript section drafts
• Citations, in the format defined by staff
• Provide full text references as PDFs or URLs, if not part of the literature identified by the search

Organizational Representative

Responsibilities in detail:

• Communicate and establish the represented organization’s process for inclusion of the representative as an author, and the organization’s process for review, approval, and endorsement
• As an author:
  • Adhere to author guidelines
  • Provide expert input as well as insight into the organization’s views, resources, and related considerations
  • Establish with the writing panel and the represented organization expectations of representation – that is, whether their vote will reflect their individual view or will represent the organization
• If a representative without pursuing authorship, self-determine participation in order to achieve the aim of the organization’s involvement (approval, endorsement, etc.) according to the timeline
• Liaise with the organization represented to keep it apprised of progress
• Commit to deadlines and milestones

Staff Lead

Responsibilities in detail:

• Develop manuscript proposal with panel lead(s) and put into process for review
• Identify panel invitees with panel lead(s)
• Provide documents detailing standard processes for manuscript proposal, literature review, writing, external review, submission, publication, dissemination, and promotion
• Guide panel leads and members in adherence to processes
• Primary contact for librarian and other consultants (e.g., EndNote consultant, copyeditors) and publisher
• Development of reference list (potentially in collaboration with consultant); provide instruction in advance for authors to notate references
• Format manuscript to conform with journal requirements
• Facilitate external review, as appropriate for the manuscript
• Facilitate endorsement by partnering organizations, as appropriate for the manuscript
• Submit manuscript to journal
• Coordinate with PR firm for media activities in collaboration with appropriate staff

Librarian

Responsibilities in detail:

• Develop search strategy based on the manuscript’s approved questions
• Obtain staff and panel’s approval for search strategy(s)
• Run search strategy (adapted as needed for each specific database) in at least two databases
• Perform first exclusions based on defined criteria
• Provide lead staff with included and excluded EndNote file and PRISMA file

Appendix H: Inclusive Language Guide ¹

Introduction

The evolution of language in any field warrants periodic efforts to establish consensus and provide guidance for the nomenclature it uses, in the interest of clarity, consistency, and usability of its communications. This is especially important for communications that inform decisions made for healthcare safety and patient care.

The Handbook Task Force developed this guide for expert guidance documents, guidelines, research manuscripts, and other written materials. It focuses on terminology and phrasing that is relevant and feasible for authors to adhere to consistently in the workflow of manuscript development.

This guide does not address all possible scenarios. The topics covered will evolve, as will the nomenclature. Given the challenges in providing comprehensive examples that may go out of date for certain areas, this document recommends that authors and other participants seek further information through reputable sources as needed for writing projects.

This document will be reviewed and revised on a periodic basis. It adheres to the sponsoring organization’s Diversity, Equity, and Inclusion Pledge.

General Principles

• As appropriate, provide definitions for clarity.
• Be appropriately specific for the purpose of the work and able to explain the reasoning for specificity or differentiation.
• Choose terminology and phrasing that is respectful of a person’s individual identity. When uncertain, seek reputable sources for prevailing approaches.
• Be sensitive to labels. When using descriptors, do not make assumptions. Use consistent phrasing. Include appropriate corollaries to avoid implying a “norm” and an “exception.”
• When citing or describing a study that did not apply these principles, use the terminology and phrasing from that study when needed to inform the guidance document or guideline.

Terminology

Those Who Work in Healthcare

• For all paid and unpaid persons who serve in healthcare settings and whose primary intent is to protect or improve health, use healthcare personnel (HCP) ². When needed, collectively HCP also may be referred to as the healthcare workforce.
• For HCP who do not work in clinical care spaces, use non-clinical healthcare personnel (non-clinical HCP).
• For HCP who work in clinical care spaces, use clinical healthcare personnel (clinical HCP). As needed for the communication, clinical HCP may be further differentiated as:
  • Patient-interacting HCP
  • Prescribing HCP: persons who have authority (independently licensed or as authorized by their employer) to make treatment decisions for patients
  • Non-patient-interacting HCP

Visitors

• For people who enter a healthcare facility but are not patients, HCP, or persons in non-health-related roles (e.g., restaurant employees), use visitors.
• To specify a visitor who is a primary source of support for the patient’s activities of daily living (ADL), labor and delivery, or a procedure and recovery, use support person or primary caregiver (use the term most appropriate for the population and situation being discussed).
• To convey a visitor’s potential exposure due to close or sustained contact with a patient who has a communicable disease, use time- or proximity-based definitions specific to the infectious agent, rather than “household contact.” For conciseness, after defining the time- or proximity-based conditions that constitute exposure to the infectious agent, the authors may subsequently use “close contact” while including the definition in the communication.

Person-First and Identity-First Language

• Describe people in ways that maintain their integrity as individuals. Use terms that are broadly inclusive unless specificity is needed for the purpose of the communication.
• Before beginning the communication, identify conditions and situations that may be relevant to the populations and scenarios discussed (e.g., illness, disease, living situation, sexual activity or identity, gender identity, language, ethnicity, citizenship status):
  • In general, recognize a person before their condition or situation. Often, this may be conveyed as “a person with…” or “a person experiencing…” or “a person who is…”
  • Exceptions apply:
    • If a person prefers a different phrase to describe themselves, use that phrase instead.
    • Certain groups may prefer identity-first language. Per the American Psychological Association (APA) ³, in these cases it is permissible to use either a person-first or identity-first phrasing, or a mix, until the group clearly states a preference for one approach.
  • Many examples and variations of person-first and identity-first language exist; seek reputable sources for preferred phrasing.
• In general, do not describe people by sexual activity. If a communication needs to refer to sexual activity(s), describe the body part(s) used in that activity (e.g., persons who have anal receptive intercourse). Use prevailing approaches that have been identified from reputable sources.

Gender

• The same principles of person-first and identity-first language apply: communications should respect a person’s identity as an individual.
• Similarly, before beginning the project, identify what may be relevant to the populations and scenarios that will be discussed. When uncertain, use reputable sources to identify prevailing approaches to inclusive terminology and phrasing.
• Use “individuals,” “persons,” or “people” to refer to human beings. “Persons” may be used to emphasize that individuals make up a collective group.
• Use gender-inclusive occupational nouns such as “chair” or “chairperson” ⁴.
• Use gender as an adjective, not a noun (e.g., “female person”).
• When referring to someone with a pronoun, use the singular gender-neutral (they/them) ³, unless it is demonstrably necessary to differentiate.
• Use “gender” and “sex assigned at birth” classifications appropriately:
  • Gender refers to a person’s social identity.
  • In general, avoid “sex” or “sex assigned at birth.” When demonstrably necessary to the project, apply person-first phrasing, such as “people who were raised female/male” ⁵.
  • As of the writing of this guide, “transgender” and “gender nonconforming” are generally agreed-upon terms ⁵.
• Avoid assumptions and apply phrasing consistently. For example, if you refer to people who are transgender, include the corollary (“people who are cisgender”) ⁵.
• When referring to pregnancy, birth, and lactation, refer to the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), or similar reputable sources for preferred terminology. In general, use gender-neutral terminology (e.g., “pregnant person” or “lactating person,” not “pregnant woman” or “lactating mother”).

Race and Ethnicity

• Avoid describing race and ethnicity as biological factors. Inclusion of racial or ethnic information should be relevant to the purpose of a project. When included, provide the reason the information is reported (e.g., to exhibit systemic disparities). Do not report race and ethnicity information in isolation ⁶.
• If included among collected data, provide a way for people to self-identify their race and ethnicity.
• Use racial and ethnic terms as adjectives, not nouns.
• Be aware of the relevance of geographic influence and regionalization in the origins of terms. If uncertain, seek information from reputable sources.
• Capitalize the names of races, ethnicities, and tribes ⁶.

Age

• For individuals 18 and older, use specific ages or age ranges rather than descriptors. Adult age ranges are not standard and have been variably defined. Use specific ages or age ranges even for commonly used terms (e.g., “pregnant person over the age of 35” or “persons over the age of 65” instead of “geriatric pregnancy,” “advanced maternal age,” or “older adults”).
• Check AAP for commonly accepted definitions for age categories of pediatric patients (e.g., neonate, infant, child, adolescent). If choosing a term different from those specified by AAP, explain why.

Interested Persons and Groups

For groups and individuals who may be interested in or affected by a decision or action, use “interested persons and groups” rather than “stakeholders” or “working partners.” The term “stakeholders” is no longer favored due to historic connotations, and “working partners” may not convey the breadth of those relevant to implementation of a decision or action.

Practice Statement

The term “practice statement” replaces “white paper” as a categorization of document that summarizes views on healthcare epidemiology and antimicrobial stewardship program-related practices (e.g., infrastructure, business cases, quality outcomes and metrics). A practice statement does not adhere to the literature search process outlined in this Handbook or other rigorous literature review process.

Resources

The following are reputable sources for inclusive language guidance:

Appendix I: Acronyms ¹

References