IP Guideline Development Handbook — Part 1: Development Process

Purpose and Scope

The guidelines committee (GLC) developed this handbook to define a uniform and rigorous methodology for use by sponsored writing groups that produce guidelines, expert guidance documents, consensus statements, and practice statements. This handbook is treated as a living document and may be revised at the committee’s discretion.¹

The handbook was first published in January 2016 and does not govern documents developed before that date. Subsequent revisions were completed in January 2017, August 2019, December 2021, and October 2024. Each version was reviewed and approved by the GLC and the Board of Trustees, with approvals recorded in October 2015, January 2017, August 2019, January 2022, and October 2024.

Authorship of the Handbook

The following task forces contributed to the development and revision of this handbook across its successive editions:

Methodologies Task Force (Original Authors and January 2017 Revisions)

• Kristina Bryant, MD, Chair
• Deborah Yokoe, MD, MPH, Task Force Co-Chair
• Gonzalo Bearman, MD, MPH, GLC Chair
• Rekha Murthy, MD, GLC Vice Chair
• David Banach, MD, MPH, MS
• Bernard Camins, MD
• E. Patchen Dellinger, MD
• Susan Huang, MD
• B. Lynn Johnston, MD
• Surbhi Leekha, MBBS
• Mark E. Rupp, MD
• Valerie Deloney, MBA (staff)

GLC Handbook Task Force, August 2019

• Joshua Schaffzin, MD, PhD, Task Force Chair, GLC Vice Chair
• Deborah Yokoe, MD, MPH, GLC Chair
• Meghan Baker, MD, ScD
• Waleed Javaid, MD
• Michael Stevens, MD, MPH
• Marci Drees, MD, MS
• Emily Sickbert-Bennett, PhD
• Valerie Deloney, MBA (staff)

GLC Handbook Task Force, December 2021

• Emily Sickbert-Bennett, PhD, Task Force Chair, GLC Vice Chair
• Mayar Al Mohajer, MD, MBA
• Jaffar Al-Tawfiq, MD
• Duha Al-Zubiedi, MD
• Meghan Baker, MD, ScD
• Shandra Day, MD
• Joshua Schaffzin, MD, PhD, GLC Chair
• Valerie Deloney, MBA (staff)

GLC Handbook Task Force, October 2024

• Emily Sickbert-Bennett, PhD, Task Force Chair, GLC Past Chair
• Meghan Baker, MD, ScD, Task Force Vice Chair, GLC Chair
• Werner Bischoff, MD, MS, PhD
• Susan Cali, MSN, RN, MHA, CIC
• Katia Halabi, MD
• Eric Lofgren, PhD, MSPH
• Nicole McNeil, MPH, CIC
• Ananthanarayanan Rajalakshmi, DNB
• Felicia Scaggs Huang, MD, MS
• Mamta Sharma, MD
• Bhavarth Shukla, MD, MPH
• Lynne Strasfeld, MD
• Brenda Tesini, MD
• Matthew Washam, MD, MPH
• Valerie Deloney, MBA (staff)

Introduction

Documents sponsored by the professional society that deliver recommendations in the domains of infection prevention and control (IPC), healthcare epidemiology, and antibiotic stewardship are organized into four broad categories:

1. Guidelines
2. Expert guidance documents
3. Consensus statements
4. Practice statements

The category assigned to a given recommendations-based document is determined by the nature of the literature review process it employs. A category is designated when the document is initially commissioned; however, the category may be changed after the preliminary literature review if the quality and character of the available evidence warrant reclassification. Any change in category must be reviewed and re-approved by the GLC, the Publications Committee, and the Board of Trustees.

Consensus statements follow a dedicated development process defined in Appendix C.

Additional document types are described in Appendix A, but the procedures in this handbook do not apply to their development. Documents that do not formalize evidence-based or consensus-based recommendations — but instead articulate the organization’s position on relevant issues or time-sensitive topics — may use one of the formats outlined in Appendix A or an alternative format at the discretion of the responsible committee and the Board of Trustees.

Definitions of Guidelines, Expert Guidance Documents, Consensus Statements, and Practice Statements

The sponsoring organization places high value on multi-society documents and actively encourages collaboration aimed at producing multidisciplinary, broadly vetted, consistent, and concise recommendations that serve the interests of all parties and groups involved in healthcare delivery.

Guidelines

• Topics of high priority for which an adequate body of published literature exists, as judged by the GLC and Board of Trustees, may be considered for the guideline format.
• Guidelines employ Grading of Recommendations Assessment, Development and Evaluation (GRADE) or a comparable evidence-grading methodology.
• Topics on which guidelines have been published previously will be evaluated to determine whether continuation in the existing guideline format or conversion to the expert guidance format is more appropriate.

Expert Guidance Documents

Expert guidance documents provide practice recommendations when the available literature is insufficient to support a GRADE-based guideline.

Characteristics of expert guidance documents:

• The topic is important to the delivery of safe and effective healthcare.
• They address topics of relatively narrow scope that lack the level of evidence needed for a formal guideline developed with GRADE or a similar methodology.
• They use the literature review process described in this handbook without assigning evidence grades to individual recommendations.

An expert guidance document rests on a synthesis of limited evidence, theoretical rationale, current practices, the writing group’s collective opinion, and consideration of potential harm. Depending on the topic, the document may also draw on survey data from the organization’s research network.

Compendium Format

The compendium format is modeled on the “Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Settings” and is intended to offer practical, relatively concise guidance grounded largely in previously published guidelines. The compendium format:

• Generally covers topics that are broad in scope.
• Includes recommendations backed by evidence within a defined area.
• May also incorporate recommendations based on expert opinion.
• Draws on recommendations from previously published healthcare-associated infection (HAI) prevention guidelines.
• Classifies recommendations into two tiers:
  • (a) Essential practices that should be adopted by all acute care hospitals.
  • (b) Additional approaches for use in settings and/or populations where HAIs remain uncontrolled after full implementation of essential practices.
• Summarizes implementation strategies for the recommendations.
• Follows the literature review process outlined in this handbook rather than GRADE or a comparable methodology.
• Assigns an appropriate level of evidence to each recommendation (see Appendix D).

Consensus Statements

A consensus statement is designed to deliver a rapid response on a time-sensitive topic. It may include recommendations and rationale, but its development does not involve a systematic literature search. Consensus statements:

• Address time-sensitive topics, with development completed in fewer than 6 months.
• Are limited to fewer than 15 submitted pages (MS Word, double-spaced, excluding references and tables).
• Are not required to follow the literature search process described in this handbook.
• Employ the expert consensus process outlined in this handbook (see the Consensus section below).

Practice Statements

The practice statement format (formerly referred to as the “white paper” format) summarizes perspectives on practices related to healthcare epidemiology programs — for example, infrastructure, business cases, quality outcomes and metrics, and similar topics.

Practice statements do not follow the literature search process set out in this handbook or any other formal systematic literature review methodology.

Additional Definitions

General definitions for additional document formats that fall outside the scope of this handbook are provided in Appendix A.

Proposal Process

Guidelines, expert guidance documents, consensus statements, and practice statements all require approval of a manuscript proposal by the GLC, the Publications Committee (when publication in a sponsored journal is proposed), and the Board of Trustees. Topic proposals are submitted to the GLC by completing a Manuscript Proposal Form (see Appendix B). Proposals may be submitted by individuals and groups including, but not limited to: the Board of Trustees, members of the GLC, organizational committees, special interest groups, and partnering organizations. The GLC and subsequently the Board of Trustees select topics for development based on perceived interest, need, target population, audience, and available resources. When existing guidelines or expert guidance documents from other specialty organizations or agencies cover the same topic, the Manuscript Proposal Form must include a clearly articulated justification for pursuing an organization-led document.

Approval of topics requires a vote by the GLC,² a determination of appropriateness for sponsored journals (when relevant) by the Publications Committee, and final approval by the Board of Trustees.

The 2022–2027 strategic plan directs the GLC to oversee the publication of three recommendations-based documents (guideline, expert guidance, consensus, or practice statement) in sponsored journals each year for five years.

Requirements for Collaborative Documents

Collaborative projects that involve joint publication with other societies require:

• A memorandum of understanding (MOU) signed by all participating organizations and reviewed by the GLC, Publications Committee, Board of Trustees, and the editors of affiliated journals, as appropriate.
• Agreements between the societies and their respective publishers. One publisher may serve as the lead copy editor and publisher to ensure that each co-published article is identical in content across all journals.
• Agreements between the societies and their respective publishers on the means of disseminating the work, including the article’s presentation on websites, social media, and other publicity channels.

Manuscript Development Queue

• The manuscript development process defines a 32-month development timeline for guidelines and expert guidance documents (see Appendix E). Up to eight manuscripts may be in active development at any one time.
• Expert consensus statements are intended to address a need for rapid response and are developed over approximately 6 months or fewer.
• Practice statements are developed following the process outlined in Appendix E within 24 months or fewer, omitting the 10 months allocated for the systematic literature search used by expert guidance documents.

Adjudicating Priority of Development and Publication

Manuscript proposals are evaluated and approved by the GLC, Publications Committee, and the Board of Trustees on a biennial basis. The GLC typically initiates guidelines and expert guidance manuscripts approximately four years in advance of their anticipated publication date.

If a manuscript proposal could affect the existing manuscript queue, it may:

• Be flagged by the Publications Committee and Board of Trustees as potentially requiring de-prioritization of other manuscripts and/or additional resources.
• Require that the proposers provide additional information justifying the change to the queue, de-prioritization of other manuscripts, and/or additional resources.

Individuals who serve on writing panels whose documents are under consideration and who also serve on a leadership body responsible for approving changes must recuse themselves from those decisions.

Consensus Statements

Because of their rapid development timeline (fewer than 6 months), expert consensus statements may be added to the existing portfolio of documents in development. Before approval, the organization will evaluate the effect on the manuscript queue, the need for additional resources to support development, and the feasibility of procuring those resources. Requests for additional resources require Board of Trustees approval.

Practice Statements

Practice statements, which follow a 22-month timeline, are added to the existing manuscript queue. These documents must undergo the same approval process, including assessment of potential changes to the queue and increases in resources.

Publication Considerations

• All submissions to affiliated journals must be double-spaced, in 11-point sans-serif font with normal margins, and may not exceed 50 pages in this format. The Publications Committee considers exceptions on a case-by-case basis.
• In general, sponsored guidelines and guidance papers are published outside of a paywall for at least 6 months following their publication date. This means non-subscribers to the journal can access them at no extra cost to the authors, the society, or the reader, thereby promoting the uptake of recommendations for patient and healthcare personnel safety. Exceptions may apply.
• Joint publication requirements are described above under “Requirements for Collaborative Documents.”

Process Overview

The full development timeline is outlined in Appendix E.

As a general rule, authors have 32 months from acceptance of a guideline or expert guidance manuscript proposal by the Publications Committee to final submission of the manuscript for publication. The GLC and Publications Committee periodically review the status of all approved manuscripts. Projects that exceed the 32-month timeline may require re-approval. Consensus documents should be developed within 6 months of proposal approval. Practice statements should be developed within 24 months of proposal approval.

The actual timeline may vary depending on the document type, the topic, and the interested parties and groups involved. Any anticipated alterations to the timeline should be flagged with the GLC, and the Publications Committee and Board of Trustees should be notified as appropriate.

Refer to Appendix F for the components of the review process.

Writing Panel Composition

A typical panel consists of 8–15 members who meet regularly via video conference and may also meet in person at relevant professional conferences.

The manuscript proposal form (see Appendix B) requires submitters to include:

1. Chairs and co-chairs. Those who submit manuscript proposals may list themselves or others as chairs. When others are listed, submitters should obtain approval from the potential chairs or co-chairs before submission.
2. Panel members (i.e., authors; prior approval from proposed members is not needed). Proposed panel members may be identified through a call for applications following proposal approval, from responses to the annual “Call for Volunteers,” past volunteer history, known subject matter expertise as evidenced by publications, and/or experience developing similar documents.
3. Partnering organizations will be invited to nominate representatives (prior approval by nominees is not needed).

Manuscript proposal forms, including the proposed panel members and composition, are confirmed by the GLC, Publications Committee, and Board of Trustees.

Inclusive Guiding Principles

Writing panels adhere to inclusive guiding principles developed by the organization’s Diversity, Equity, and Inclusion Committee. These principles aim to:

“Actively implement strategies that incorporate diversity, equity, and inclusion principles to foster a sense of belonging, facilitate innovative solutions, and enhance decision-making.”

The guiding principles specify parameters for gender, race and ethnicity, geography (including rural settings), professional roles (non-physician members), primary practice setting (community-based, ambulatory, long-term care, correctional health, and Indian Health Service), and years in practice. These principles are updated annually. Those selecting writing panel members should request and use the most recent version of the Inclusive Guiding Principles document when assembling the panel roster.

Those selecting writing panel members should also consider areas of specialization (such as pediatrics and stewardship), as detailed below. In addition, the panel should include:

• Clinicians with expertise in the relevant topic area(s).
• Pediatrician(s), whenever the management of pediatric contexts or children may be addressed.
• Antimicrobial and/or diagnostic stewards, whenever the procurement, allocation, prescribing, de-escalation, or other considerations related to testing and/or treatment may be addressed.
• The panel may additionally include individuals with expertise in:
  • Microbiology
  • Nursing
  • Long-term care
  • Ambulatory care
  • Primary care
  • A subspecialty with a unique interest in the topic under consideration
  • Hospital medicine
  • Other domains as appropriate (e.g., patient/public advocacy)
• Early in the manuscript development process, the GLC encourages panels to invite interested parties and groups (see Appendix D) to participate. Participation may take two forms:
  • Joint development: Developing a guideline jointly entails having co-chairs from each organization and equal formal representation on the panel. Joint publication is a separate consideration and is generally discouraged for organization-sponsored documents.
  • Endorsement:
    • Review of the final product by interested parties and groups, OR
    • Addition of a member from the potential endorsing organization to the panel, followed by review of the final product by interested parties and groups.

Patient Engagement

Writing panels may engage patient interest groups during the scoping and review phases of guideline, expert guidance document, consensus statement, and practice statement development. The specific groups involved will depend on the topic(s) the document is intended to cover. These groups may include, but are not limited to: National Patient Safety Foundation/IHI, Peggy Lillis Foundation, MRSA Foundation, MRSA Survivors Network, Sepsis Alliance, Empowered Patient Coalition, The Institute for Patient- and Family-Centered Care, Patient Safety Movement Foundation, and Alliance for Safety Awareness for Patients. Patient advocacy groups interested in contributing to guideline and guidance development should contact the sponsoring organization.

Conflict of Interest Policy

The sponsoring organization concurs with the Institute of Medicine’s definition that conflict of interest (COI) is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.”³

1. The primary interests of concern encompass “promoting and protecting the integrity of research, the welfare of patients and the quality of medical education.”
2. The secondary interest “may include not only financial gain but also the desire for professional advancement, recognition for personal achievement and favors to friends and family or to students and colleagues.”

On an annual basis — or whenever updates arise — all authors of guidelines, expert guidance documents, consensus statements, and practice statements must disclose financial relationships and organizational affiliations that pose a potential conflict of interest. Authors must also describe a management plan that includes recusal and other appropriate actions when issues arise that are relevant to one or more of their disclosures.

Relationships requiring disclosure include:

A statement of “nothing to disclose” in a manuscript signifies that the individual has no financial or non-financial relationships, and no primary or secondary interests, that could compromise professional judgment regarding the content of the specific document.

COI Review

The chair(s) of the writing panel and the GLC flag disclosures that require further consideration by the Conflict of Interest Review Committee. That committee determines whether actual conflicts exist and identifies management strategies to mitigate any real or perceived undue influence arising from financial relationships.

Anyone with a conflict of interest is required to submit a management plan. The management plan is a self-identified action plan provided by any member who discloses an external commercial financial relationship. Its purpose is to clarify the disclosed relationships and offer a guide for governance and the execution of balanced work. The Conflict of Interest Review Committee approves each management plan.

Disclosures are shared with the entire writing panel, and panel members are responsible for reporting updates to their disclosures at the start of each meeting.

Authors’ COI disclosures are included in the published manuscript under the “Acknowledgements” section.

Indemnification and Copyright

Authors of organization-sponsored documents that have been approved by the Board of Trustees are covered against individual liability under the organization’s insurance policy.

All guidelines, expert guidance documents, practice statements, and expert consensus statements include the following statement:

“No guidance document can anticipate all clinical situations, and this paper is not meant to be a substitute for individual clinical judgment by qualified professionals.”

The sponsoring organization retains copyright for all sponsored manuscripts. The organization adheres to the copyright policy of its official journal, Infection Control and Hospital Epidemiology (ICHE).⁴ If a manuscript is published externally, approval from the Publications Committee and the Board of Trustees will be obtained through an official letter of agreement with the other publication.

Systematic Literature Search and Review

This process applies to expert guidance documents only. Guidelines follow the methodology of GRADE or a comparable evidence-grading framework. Practice statements and expert consensus statements do not undergo a systematic literature search and review. To ensure consistency and minimize the potential for bias, the methods governing search strategy and study selection are established before data collection begins.

The principles of transparency, consistency, and recordkeeping form the foundation of the literature search and review process. These principles and the rationale behind them are shared with writing groups at an introductory meeting led by the writing group chair, staff, or GLC chair.

1. Scope

Define the scope of the document.

2. Questions

Writing panels develop the set of question(s) the manuscript will seek to answer before formulating a search strategy. Questions may follow the PICO (population, intervention, control, and outcome) framework but are not required to, because the nature of infection prevention literature does not always provide each PICO element for every question. The questions establish the scope of the document and maintain the framework for its content.

3. Search Strategy

(a) The organization engages a consultant medical librarian to develop search strategies for expert guidance documents based on the questions identified by the panel. The writing panel reviews and approves the search strategy. The librarian is responsible for de-duplicating articles when multiple search strategies and/or databases are used. The Methods section of the manuscript will disclose that a medical librarian was engaged.

(b) The medical librarian follows these parameters:

• Database. At minimum, the recommended database for the literature review is MEDLINE (accessible through PubMed or Ovid). Additional databases — such as EMBASE, CINAHL, or the Cochrane Database of Systematic Reviews — may be used to supplement the search with the agreement of the writing group. If additional databases are used by one member, the rest of the writing group should use the same database(s). Any additional databases used will be explicitly described in the document text.
• MeSH (Medical Subject Headings). Official MeSH terms should be used to the greatest extent possible for conducting the search. Non-MeSH terms are permissible provided the search strategies remain congruent.
• Time Period. Before the librarian develops the search strategy(s), the writing panel sets a reasonable time period from which articles will be selected, informed by previously published guidance and the relevance of evidence to current practice. If a document on the same topic has been published previously by the GLC, the literature review should generally begin from the date the last search was current. The Methods section will document the dates covered by the search.
• Publication Language. Only English-language articles are included.
• Publication Type. Only full-length articles are included. Potential reasons for exclusion include:
  1. Outside the defined scope of the document, as determined during the first phase of development.
  2. Excluded based on: language, setting, treatment, disease, diagnostic process, comorbidity, age group, sample size, laboratory study, sex, duration, intervention, procedure, or administration route.
  3. Insufficient or unacceptable (as agreed upon a priori): study design, intervention data, randomization, control, design, or data analysis.
  4. Inaccessible full-text article.
  5. Lack of peer review. The organization does not include in its search yields — and therefore does not cite in its manuscripts — scientific abstracts (such as those published at professional conferences), unpublished research and trials, manuscripts that have not undergone some form of peer review, or articles published after the timeframe of the search yield.
  6. Commentary or editorials.
  7. Case studies.

(c) The restrictions above apply to the guidance portion of the document — that is, the recommendations, rationale, and evidence level (if applicable). Additional relevant information that does not qualify for inclusion in the guidance portion may be incorporated into the background or discussion sections of the document and/or in a section on “future research needs” or similar.

(d) Recordkeeping.

• The questions, search strategy records, and PRISMA diagram may be included as an unpublished appendix accessible electronically, at the discretion of the writing group and/or publisher.
• The methods and results of the literature search will be retained by the organization’s office.

(e) Primary Review. Upon receipt of the article yield, two members of the writing group independently (blinded) review the title and/or abstract of each paper to identify when predetermined eligibility criteria are not met. For transparency and accuracy, the organization uses an abstract management service to maintain a record of all papers and publications identified by the search and to facilitate both primary and secondary/full-text review.

If the two reviewers disagree about whether an article should be included, a third member or the panel chair adjudicates the conflict.

(f) Secondary/Full Review and Extraction. The articles that were not excluded during primary review are reviewed in full, divided evenly among panel members. Each reviewer completes a custom extraction form documenting the study type, population, and relevance to specific PICO questions and the topic in general. This secondary review determines which articles are suitable for inclusion and informs the background and recommendations of the document. If the two reviewers disagree on suitability for inclusion, a third member or the chair reviews the article in question.

(g) Updating the Literature Search. If a manuscript project is delayed by 6 months or more, the panel may request that the librarian re-run the same search strategy(s) used for the initial literature search. When this occurs, screening is performed by one member per title/abstract via the abstract management service to identify full-text articles that may potentially be added to the document.

4. Submission to National or International Guidelines Databases

If the organization determines that the manuscript will be submitted to a national or international guidelines database, authors will create an evidence table for all articles included in the final manuscript. This table does not need to be published with the manuscript.

Exceptions

(a) On occasion, when the panel deems it necessary to include journal article(s) that were not part of the literature search conducted to answer the question(s), the panel will separately identify and disclose the citations for those articles in the manuscript. Articles may be added:

• If they are published after the completion of the literature search and the panel determines they are essential to include, or
• If the panel agrees that the thorough literature search failed to identify a relevant article.

(b) The panel may also decide in advance, based on the topic, that the search should be expanded to resources outside the databases listed above. This may include “grey literature” such as federal, state, and non-governmental resources (e.g., CDC, AHRQ, WHO, MSF).

Methods and Resources Not Utilized

(a) Review of the reference lists in review articles or other publications may be used only to verify that the literature search was complete. Using review articles and other publications as a source for articles may bias the writing group by including articles that have been cited before while omitting articles that would have been discovered through a thorough independent search.

(b) Unpublished works, or articles that have not been peer reviewed — including scientific abstracts (such as those published at professional conferences), unpublished research or trials, and articles falling outside the timeframe used by the search strategy(s) — are not utilized.

(c) Findings from research articles that fall outside the scope of the document, even if the article appeared in the search yield, should not inform the guidance portion of the manuscript (recommendations, rationale, and assessment of evidence level, if applicable).

Inclusion of Products, Services, or Treatments

1. When a recommendation discusses healthcare products, services, or treatments, it must use generic names.
2. Recommendations and their rationale must not refer to organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
3. To the best of the writing panel’s ability, the panel will identify whether any draft recommendations depend on the use of products, services, or treatments known to be highly vulnerable to discontinuation, shortages, or lack of supply.
   • (a) The panel will evaluate these recommendations and consider the known vulnerabilities for their potential effect(s) on implementation of the recommendation as written.
   • (b) If the panel decides that vulnerable products, services, or treatments should be included, the document will acknowledge the availability or supply issues that the panel considered.

Consensus

A formalized process for reaching panel consensus is a distinctive feature of expert guidance documents and consensus statements. Recommendations are listed alongside rationale statements that take into account relevant evidence as well as the collective agreement of the group. Voting on and discussion of recommendations should occur in tandem with review of the supporting rationale and evidence. Consensus around recommendations and rationale is determined through an anonymous ranking and comment period. Consensus thresholds follow the Consensus Statement Process Guide (see Appendix C):

Review and Approval Process of Guidelines and Expert Guidance Documents

Internal and External Review

The GLC Chair assigns at least two primary reviewers from the committee to review the document and provide written comments using a standardized review form. Reviews should generally be completed within a 2- to 4-week timeframe; for external documents, reviewers should make best efforts to complete the review within the timeframe requested by the originating organization. The full GLC also has the opportunity to review and comment on the document during this period, either through presentation of the reviews and subsequent discussion or outside the formal review.

Comments received from the GLC are forwarded to the writing panel chair for incorporation into the draft as deemed appropriate. Within 2–4 weeks, the writing panel chair should return the revised document draft with a response to each comment, indicating where and why reviewer recommendations were incorporated and providing the rationale for any that were not. Staff then send the revised document and the responses to the GLC for review.

Guidelines, expert guidance documents, and other documents considered for endorsement should use only generic names when discussing products, services, or treatments in their recommendations and rationale. Similarly, the recommendations and rationale in these documents should not refer to organizations whose primary business is producing, marketing, selling, or distributing healthcare products used by or on patients.

GLC support for a guideline or expert guidance document is demonstrated by a vote of the full committee conducted by email ballot or conference call (any writing group members or those with a relevant conflict of interest are recused from voting). A simple majority of the full committee constitutes approval or disapproval. The final recommendation of the GLC is forwarded along with the draft document to the Board of Trustees for final review and approval.

This process of review and approval by the Guidelines Committee and the Board of Trustees serves as the official peer review for sponsored guidelines and expert guidance documents submitted for publication in ICHE.

Refer to Appendix A for the groups responsible for review and approval of other types of sponsored documents.

Review by Interested Parties and Groups

This process is described in greater detail in Appendix D. Efforts to obtain review by interested parties and groups depend on the topic and circumstances surrounding the sponsored document. See the Patient Engagement section above for more information about engaging patient interest groups.

When interested parties and groups are involved in the development of a guideline or expert guidance document from the outset — or are identified later in the process as a potential endorser — staff will solicit their input and endorsement as follows:

An electronic request is sent that includes an endorsement form, the draft manuscript, and a form for comments. The organization from which endorsement is sought has the opportunity to provide comments and suggested revisions within a reasonable timeframe (4 weeks). The organization is presented with the following endorsement options:

• Full endorsement: The organization endorses the guideline as written.
• Endorsement with comments: The organization endorses the guideline and suggests attached comments for consideration.
• Non-endorsement: The organization does not endorse the guideline, specifying whether the topic falls outside the organization’s scope or whether there is disagreement with the content.

If an organization completes its review within the agreed-upon timeframe, it will be acknowledged within the manuscript. If the organization is unable to meet the deadline, the manuscript will continue through the review process and the organization may be acknowledged on the sponsoring organization’s website.

Comments from interested parties and groups (if applicable) are forwarded to the writing panel chair, who reviews them and incorporates them into the draft as deemed appropriate. The action taken for each comment or recommendation, along with the rationale, is documented on the review form. Not all recommendations must be accepted, but the rationale for each decision should be recorded.

Periodic Review of Guidelines and Expert Guidance Documents

Maintaining up-to-date content in guidelines and expert guidance documents is a challenge that requires a commitment of resources to monitor emerging literature and scientific consensus and to determine whether a guideline should be revised or has become obsolete.

On average, guidelines and expert guidance documents are reviewed on a 4-year rotation. The “Compendium of Strategies to Prevent HAIs in Acute Care Settings” is reviewed every 5 years. Situations that may prompt an update include substantive changes in:

• The evidence on existing benefits and harms
• The outcomes that were considered important
• Available interventions
• The evidence or consensus that current practice is optimal
• The values placed on outcomes
• The resources available in healthcare

As with internal and external document reviews, the GLC Chair assigns at least two primary reviewers from the committee to review the document and provide written comments using the review form. Reviews should generally be completed within a 2- to 4-week timeframe. The full GLC also has the opportunity to review and comment on the document during this period.

In addition to determining whether new evidence or developments potentially invalidate current recommendations, the GLC should discuss the need for new recommendations within the context of the existing guideline — including recommendations that may have been previously excluded for various reasons or that have emerged in the interim.

Once the decision is made to update a guideline or expert guidance document, an expert panel is convened. The expert panel may include many of the original panelists, but its final composition may differ from the original group. As with new guideline panels, membership is reviewed and approved by the GLC Chair and included in the manuscript proposal form approved by the GLC and Board of Trustees. All panel chairs and members must comply with current conflict of interest disclosure policies.

The process for conducting a full update — including review and approval of the manuscript — is the same as outlined in this handbook for sponsored guidelines and expert guidance documents.

Guidelines or expert guidance documents undergoing revision will be flagged on the organization’s website to indicate that an update is in progress.

The Guidelines Committee may retire documents that have become obsolete. Retired documents will be maintained on a separate page from current guidelines and expert guidance documents.

References