IP Guideline Development Handbook — Part 2: Document Types, Proposal Forms & Evidence Classification

Appendix A: Definitions of Organization-Sponsored Documents

The development, review, and publication processes described in this Handbook apply to guidelines, expert guidance documents (including Compendium documents), consensus documents, and practice statements. The preparation of other manuscript types falls outside the scope of this Handbook.¹

Peer Reviewers for Sponsored Documents Submitted to Affiliated Journals

Two distinct sets of peer reviewers are responsible for organization-sponsored documents submitted for publication in affiliated journals.

Guidelines Committee and Board Serve as Peer Reviewers For	Publications Committee and Board Serve as Peer Reviewers For
Briefs	Knowledge, Skills, Abilities (KSA)-style papers
Compendium documents	Practice Statements (without practice recommendations)
Guidelines	Commentaries
Expert Guidance Documents
Consensus Statements
Practice Statements (with practice recommendations)

Document Types

The following table describes each manuscript type sponsored by the organization, the body responsible for oversight and review, the designated peer reviewer for documents submitted for publication in Infection Control & Hospital Epidemiology (ICHE), and a representative example. Documents marked with an asterisk (*) are governed by this Handbook.

Type of Manuscript (* = governed by this Handbook)	Definition	Overseen by	Reviewed by	Peer Reviewer (for documents submitted for publication in ICHE)	Example
Brief	Clarification or update to an existing document (guideline, practice statement, position paper).	Relevant committee (GLC, Education, Research, PPGA, etc.)	Overseeing committee, Board	N/A (published online)	Response to Institutions’ Implementation of 2010 Guideline for Healthcare Workers Infected with Bloodborne Pathogens, October 2014
Compendium*	Synthesis of evidence and current guidelines for the prevention of healthcare-associated infections (HAIs), including intervention strategies, special precautions, and implementation approaches.	GLC	GLC, Board, Expert Panel, Advisory Panel, External participants (partners, endorsing and sponsoring organizations), Publications Committee (identification of potential critical issues related to publications process or considerations with potential to affect impact factor)	GLC, Board	Yokoe DS, Anderson DJ, Berenholtz SM, Calfee DP, Dubberke ER, Ellingson KD, et al. A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals: 2014 Updates. Am J Infect Control. 2014;42(8):820-8.
Expert Guidance*	Guidance derived from a systematic literature review and the consensus of subject-matter experts (internal or external to the organization).	GLC	GLC, Board, External participants, Publications Committee (identification of potential critical issues)	GLC, Board	Rowe TA, Jump RLP, Andersen BM, Banach DB, Bryant KA, Doernberg SB, Loeb M, Morgan DJ, Morris AM, Murthy RK, Nace DA, Crnich CJ. Reliability of nonlocalizing signs and symptoms as indicators of the presence of infection in nursing-home residents. Infection Control & Hospital Epidemiology. Cambridge University Press; 2020:1-10.
Guideline*	Evidence-based guidance (internal or external) developed using GRADE or a comparable systematic methodology.	GLC	GLC, Board, External participants, Publications Committee (identification of potential critical issues)	GLC, Board	Stuart Johnson, Valery Lavergne, Andrew M Skinner, Anne J Gonzales-Luna, Kevin W Garey, Ciaran P Kelly, Mark H Wilcox. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America: 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clinical Infectious Diseases. 2021;73(5):e1029-e1044.
Consensus Statement*	Recommendations derived from a non-systematic literature review and expert consensus (internal and/or external).	GLC	GLC, Board, External participants, Publications Committee (identification of potential critical issues)	GLC, Board	Weber DJ, Al-Tawfiq JA, Babcock HM, Bryant K, Drees M, Elshaboury R, Essick K, Fakih M, Henderson DK, Javaid W, Juffras D, Jump RLP, Lee F, Malani AN, Mathew TA, Murthy RK, Nace D, O’Shea T, Pettigrew E, Pettis AM, Schaffzin JK, Shenoy ES, Vaishampayan J, Wiley Z, Wright SB, Yokoe D, Young H. Multisociety statement on coronavirus disease 2019 (COVID-19) vaccination as a condition of employment for healthcare personnel. Infection Control & Hospital Epidemiology. Cambridge University Press; 2021:1-9.
Position Paper	A statement issued by the professional society or a collaborative group regarding regulatory and public policy actions.	PPGA	PPGA, External participants, Board	N/A (published online)	Talbot TR, Babcock H, Caplan AL, Cotton D, Maragakis LL, Poland GA, Septimus EJ, Tapper ML, Weber DJ. Revised Position Paper: Influenza Vaccination of Healthcare Personnel. Infection Control & Hospital Epidemiology. Cambridge University Press; 2010;31(10):987-995.
Practice Statement*	A statement issued by the professional society or a collaborative group summarizing views on healthcare epidemiology program-related practices, administrative policy, or the state of the field. It does not follow the systematic literature search process outlined in this Handbook or any other rigorous literature review process.	Relevant committee (GLC, Education, Research, PPGA, etc.)	Overseeing committee, Publications Committee, Board, External participants; Guidelines Committee if it includes practice recommendations; Board	Publications Committee, Board	Akinboyo IC, Zangwill KM, Berg WM, Cantey JB, Huizinga B, Milstone AM. Neonatal intensive care unit (NICU) white paper series: Practical approaches to Staphylococcus aureus disease prevention. Infection Control & Hospital Epidemiology. Cambridge University Press; 2020;41(11):1251-1257.
Commentary	An expert opinion or editorial related to a guideline, practice statement, or position paper.	Relevant committee (GLC, Education, Research, PPGA, etc.)	Overseeing committee, Publications Committee, Board, External participants	Publications Committee, Board	Morgan DJ, Deloney VM, Bartlett AH, Boruchoff SE, Camagros Couto R, Oji M, et al. The expanding role of the hospital epidemiologist in 2014: a survey of the Society for Hospital Epidemiology of America Research Network. Infect Control Hosp Epidemiol. 2015;36(5):605-8.
KSA	Knowledge, skills, and abilities articles.	Relevant committee	Overseeing committee, Education Committee, Publications Committee, Board	Publications Committee, Board	Cosgrove SE, Hermsen ED, Rybak MJ, File TM, Parker SK, Barlam TF, et al. Guidance for the knowledge and skills required for antimicrobial stewardship leaders. Infect Control Hosp Epidemiol. 2014;35(12):1444-51.

Note: An asterisk (*) indicates document types governed by this Handbook.

Appendix B: Expert Guidance Proposal Form

The following form is to be completed by authors proposing an expert guidance document, compendium, practice statement, or guideline for development under the sponsoring organization’s process.

Field	Response
Draft title:
Submitted by:
Lead authors:
Contributing authors:
Contributing representatives from partnering organizations:
Possible external consultants:
Intention to submit to ICHE or ASHE:
Intention to publish in other journal(s):
Type of document based on the level of available evidence:	(See options below)
Target HCP audience:
Target patient population:
Issue in question:
Objectives:
Why does this document need to be developed?
Are there existing organization-led or co-led recommendations on this topic?
*Are there recommendations by other societies* on this topic?**
Is there perceived or documented variation in practice?
What is your estimate of currently available level of evidence?
What is the potential for this document to affect decision-making, clinical outcomes, and/or reduction in practice variation?
Estimated page count (submissions not to exceed a total of 50 double-spaced pages in 11 pt. font, not including references and appendices):
Reviewers in addition to the sponsoring organization:
Intended endorser invitations:
Estimated month of submission:
Derivative products (e.g., patient guides, pocket guides, presentation slides):

Document Type Options

The “Type of document” field offers three options, each corresponding to a different development pathway:

Expert guidance or compendium format – Requires a systematic literature search and consensus process as described in this Handbook. Estimated development timeline: 32 months.
Practice statement – May include recommendations but does not utilize a systematic literature search. Estimated development timeline: 22 months.
Guideline – Follows GRADE or a similarly rigorous methodology and requires an adequate level of published literature to achieve the document’s purpose. Duration is determined after approval and identification of required resources.

Appendix C: Consensus Statement Process Guide

Consensus Statement Requirements

Attribute	Details
Topic eligibility	The topic must be relevant to infection prevention or antimicrobial stewardship and affect patient and/or healthcare personnel (HCP) safety. Best-practices guidance must not currently exist (within the sponsoring organization or from other organizations). The topic must be time-sensitive: urgently needed (e.g., within 6 months) and/or relevant for a limited period with evolving evidence (e.g., pandemic, specific outbreak). There must be limited evidence: high levels of heterogeneity in estimated effects (i.e., a major study could fundamentally change what is currently known) and no large or definitive study (e.g., multicenter RCT) exists or is in progress. There must be practice variability: general uncertainty related to the topic with approaches that vary among similar settings.
Frequency	No more than 1 consensus statement every 6 months. Timing is a consideration during approval of the petition to the GLC.
Format	Fewer than 10 Microsoft Word pages (double-spaced, approximately 4-7 published pages). Up to 10 specific questions, each accompanied by recommendations, percentage approval, relevant remarks (no narrative rationale), and citations. Front matter must include an introduction/preface, methods section, intended-use disclaimer, recommendations, and disclosures.
Follow-up, review, and updates	After finalization, a debrief is conducted via electronic survey of panel members to solicit input, identify improvements, and gather ideas. The statement is reviewed every 5 years by the writing panel for the state of the literature. The review determines whether the statement will be: (a) Retired – the statement no longer meets eligibility criteria; (b) Updated – the statement still meets eligibility criteria (the update begins with a 3-round Delphi process using the same panel composition, replacing members who are no longer available); or (c) Upgraded – the statement is recommended for conversion to an expert guidance document or guideline (the document transfers to follow the expert guidance or guidelines process, including formation of a new writing panel).

Proposal

Step	Lead(s)	Action(s)
1	Proposal authors (2-4 members of the professional society)	Submit the manuscript proposal form (template provided) to the GLC, specifying: (1) Expertise and viewpoints to be represented, areas of expertise, individuals possessing that expertise, relevant committees/interest groups, and external organizations that should be represented; (2) Central issue, practice variation, and state of the evidence; (3) A maximum of 30 questions that may require recommendations.
2	GLC	(1) Reviews the proposal; (2) Votes on whether to approve; (3) Nominates additional members or representative groups (committees, SIGs, other organizations) and refines or adds to the proposed questions; (4) If approved, notifies the Publications Committee and Board Executive Committee of the intent to proceed.
3	Publications Committee and Board Executive Committee	Provide input on panel nominees and proposed questions.
4	Proposal authors	(1) Revise the proposal based on GLC, Publications Committee, and Executive Committee feedback; (2) Contact relevant groups and external organizations for input on the concept; (3) Make additional revisions incorporating feedback from those groups.
5	Headquarters and GLC chairs	(1) Review changes made by proposal authors; (2) Submit the final proposal to the Board for approval.
6	Board	Approves or declines the proposal for development.

Development

The development process begins with the assembly of a 20-person panel and 2 lead authors, facilitated by one electronic ranking form completed by the GLC.

Step	Lead(s)	Action(s)
1	GLC	Completes the Panel Ranking Form to identify the top 20 panel members from nominees submitted by proposal authors, the Publications Committee, the Board, committees, SIGs, and external organizations. Note: Organizational representatives vote based on their individual views but are included on the panel to provide their organization’s perspective as needed.
2	Board	Identifies 2 lead authors (first and last, or second, authors of the consensus statement) from among the 20 panel members.
3	Headquarters	Sends invitations along with author guidelines and the conflict-of-interest (COI) form.
4	COI Committee	Reviews panel members’ disclosures and management plans, and determines criteria for recusal.

Round 1

Call 1 Agenda (1.5 hours):

Welcome and introductions
Individual disclosure and group discussion of known and potential biases; norms for recusal
Review, discussion, and refinement of the set of questions contained in the final proposal

Offline Work Between Call 1 and Call 2 (completion of 2 electronic votes by the panel):

Step	Lead(s)	Action(s)
1	Headquarters	Develops and distributes Questions Vote 1 to the full panel, containing the questions from the proposal.
2	Full panel	Completes Questions Vote 1 to narrow the proposal questions to the top 15.
3	Headquarters	Develops and distributes Questions Vote 2 of the top 15 questions to the full panel.
4	Full panel	Completes Questions Vote 2 to narrow the questions to the final 10.
5	Headquarters and lead authors	Based on the final 10 questions, identify five 4-person subgroups, each assigned 2 questions. Notify panel members of their subgroup assignments.
6	Subgroup members	(1) Individually conduct and document non-systematic database literature searches (e.g., PubMed, Cochrane). Panel members should consider alternative forms of evidence beyond RCTs (e.g., case-control studies, modeling studies). (2) Identify “grey literature” (sources not available through major literature databases, e.g., governmental documents). (3) Confer electronically or by telephone to draft: (a) Recommendations, (b) Remarks based on literature findings, practice considerations, experience, and feasibility/implementation factors, (c) Citations. Note: subgroups may submit up to 3 recommendation options if they cannot achieve internal agreement. (4) Submit drafts to staff two weeks before Call 2.
7	Headquarters and lead authors	(1) Copyedit recommendations, remarks, and citations; (2) Circulate the combined questions and recommendations to the full panel.

Round 2

Call 2 Agenda (2 hours):

Disclosures of known and potential biases
Subgroup presentations
Full group discussion of recommendations

Offline Work Between Call 2 and Call 3 (completion of 1 electronic vote by the panel):

Step	Lead(s)	Action(s)
1	Headquarters	Creates and distributes the Recommendations Vote (electronic survey with comment fields) to the full panel.
2	Full panel	Completes the Recommendations Vote. When more than one recommendation option is presented, simple majority prevails.
3	Headquarters	Distributes results of the Recommendations Vote.
4	Subgroups	(1) Adjust recommendations based on panel comments; (2) Submit revised recommendations to staff 2 weeks before Call 3.
5	Lead authors	Develop front matter for the consensus statement.

Round 3

Call 3 Agenda (2-4 hours; completion of 1-2 live electronic votes by the panel):

Subgroups present and the full group discusses only the updated recommendations.
The full group (quorum of two-thirds of the panel in attendance) completes Finalization Vote 1 (electronically, live).

Outcome	Threshold
Consensus	Greater than or equal to 80% agreement. If not unanimous, votes are published with the percentage of agreement and the number of voters (n).
Finalization Vote 2 (electronic live vote)	Triggered when less than 80% agreement is reached on Finalization Vote 1. Regardless of the outcome of Finalization Vote 2, final votes are published with the percentage of agreement and n.
Majority opinion	Greater than 50% agreement after Finalization Vote 2.
No recommendation	50% or less agreement after Finalization Vote 2. Positions that were considered are included in remarks, drafted by the lead authors.

Voting thresholds are based on the ACCORD guideline for reporting consensus-based methods.²

Approval, Publication, and Dissemination

Step	Lead(s)	Action(s)
1	Headquarters	(1) Assembles and finalizes the draft with an EndNote reference list; (2) Submits draft to the GLC and Publications Committee; (3) Submits draft to represented external organizations; (4) Communications and marketing: (a) Develops a dissemination plan, including public relations, (b) Provides promotional text for external organizations.
2	GLC, Publications Committee, external organizations	Vote on approval and submit only comments consisting of copyedits that do not change meaning, or edits that would result in non-approval of the manuscript.
3a	Full panel	Reviews comments flagged as potentially leading to non-approval and submits responses along with a revised document to external organizations, the GLC, and the Publications Committee for final decision.
3b	GLC	Recommends approval to the Board.
4	Board	Votes to approve the manuscript.
5	Headquarters	(1) Adds the endorsing organizations’ statement; (2) Submits to the journal; (3) Facilitates proofs review; (4) Communications and marketing: implements the dissemination plan.

Consensus Statement Proposal Form

Table 1: Proposal Review (Completed by Headquarters)

Step	Action	Date of Submission by Proposal Authors
1	Guidelines Committee reviews the proposal, provides feedback on writing panel configuration and questions, and either declines or provides a preliminary recommendation to proceed.
2	Proposal authors revise per GLC feedback.
3	Publications Committee and Board Executive Committee consider the preliminary recommendation to proceed/not proceed by the GLC, and provide feedback on writing panel configuration and questions.
4	Proposal authors revise per Publications Committee and Board EC feedback; share with proposed groups (see Table 2 below); incorporate feedback.
5	Headquarters and Guidelines Committee Chairs review the revised proposal and make a final recommendation to the Board regarding approval.
6	Board of Trustees	Date of approval:

Table 2: Proposal Submission (Completed by Proposal Authors)

Field	Response
Title and authors
Preliminary title
Proposal author(s) (name(s) and email(s))
Affiliated committee or group (if applicable)
Topic eligibility
Will the consensus statement be relevant to infection prevention, antimicrobial stewardship, or both?
Does current guidance or guidelines for best practices exist on this topic (by the sponsoring organization or other organizations)?
Is the topic time-sensitive (e.g., needed within approximately 6 months, relevant for a short period of time, needed for patient or HCP safety in the context of evolving evidence such as a pandemic or emerging pathogen)?
Is there practice variability (general uncertainty related to the topic or varied approaches among HCP in similar settings)?
What is the current state of the evidence for the topic?
Can the topic be addressed with the consensus statement format? (Development within 6 months; recommendations identified with non-systematic literature evaluation and 3-round Delphi process conducted over 3 video conference meetings; fewer than 10 MS Word pages (4-7 published pages); up to 10 distinct questions and recommendations, each with percentage of final panel agreement, relevant remarks (no narrative rationale), and citations)
Proposed writing panel
Needed expertise
Involvement of organizational groups (committees, special interest groups)
External organizations (list organizations to involve with representatives and endorsement/approval)
Authors (maximum 20 suggested individual authors)
Proposed questions
Questions 1-30 (maximum of 30 questions suggested by the proposal’s authors for inclusion in the consensus statement; questions will undergo Delphi electronic voting to be narrowed to 10). Questions should follow PICO style: description of Population or Patient; Intervention to help the population; Comparison or alternative to the intervention; Outcome desired from the intervention.

Appendix D: Compendium Recommendations and Evidence Classifications

The recommendation categorization scheme described in this appendix is adapted from the update to the CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) recommendation categorization scheme for infection control and prevention guideline recommendations.³

Terminology

Type	Definition	Evidence Level	Implied Obligation	Wording	Example Terms
Essential Recommendation	The authors are confident that the benefits of the recommended approach clearly exceed the harms (or, in the case of a negative recommendation, that the harms clearly exceed the benefits).	In general, high- to moderate-quality evidence (see “Aggregate Quality of Evidence” below); or lesser evidence or expert opinion when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms; or when required by federal law.	HCP and facilities “should” implement the recommended approach unless a clear and compelling rationale for an alternative approach is present.	Specifies the setting and population to which the recommendation applies (e.g., adult patients in intensive care unit settings). Uses declarative verbs such as use, perform, maintain, replace.	should; should not; recommend; is recommended; recommends against; is not recommended; is indicated; is not indicated
Additional Recommendation	The authors determine that the benefits of the recommended approach are likely to exceed the harms (or, in the case of a negative recommendation, that the harms are likely to exceed the benefits).	In general, may be supported by low-, moderate-, or high-quality evidence: (1) There is high-quality evidence, but the benefit/harm balance is not clearly tipped in one direction; (2) The evidence is weak enough to cast doubt on whether the recommendation will consistently lead to benefit; (3) The likelihood of benefit for a specific patient or clinical situation is extrapolated from relatively high-quality evidence demonstrating impact on other patient populations or in other clinical situations (e.g., evidence obtained during outbreaks used to support probable benefit during endemic periods); (4) The impact of the specific intervention is difficult to disentangle from the impact of other simultaneously implemented interventions (e.g., studies evaluating “bundled” practices); (5) There appears to be benefit based on available evidence, but the benefit/harm balance may change with further research; (6) Benefit is most likely if the intervention is used as a supplemental measure in addition to basic practices.	HCP and facilities “could” or could “consider” implementing the recommended approach. The degree of appropriateness may vary depending on the benefit-versus-harm balance for the specific setting.	Specifies the setting and population to which it applies when relevant, including select settings (e.g., during outbreaks), environments (e.g., ICUs), and populations (e.g., neonates, transplant patients).	consider; could; may; may consider
No Recommendation	Made when there is both a lack of pertinent evidence and an unclear balance between benefits and harms.	N/A	N/A	“No recommendation can be made regarding…”	N/A

Aggregate Quality of Evidence

The following quality-of-evidence ratings are used for compendium-style documents.

Rating	Description
High	There is high confidence that the true effect lies close to the estimated size and direction of the effect. This typically applies when there is a wide range of studies with no major limitations, there is little variation between studies, and the summary estimate has a narrow confidence interval.
Moderate	The true effect is likely to be close to the estimated size and direction of the effect, but there is a possibility that it is substantially different. This typically applies when there are only a few studies and some have limitations but not major flaws, there is some variation between studies, or the confidence interval of the summary estimate is wide.
Low	The true effect may be substantially different from the estimated size and direction of the effect. This typically applies when the supporting studies have major flaws, there is important variation between studies, the confidence interval of the summary estimate is very wide, or there are no rigorous studies, only expert opinion.

References

This section is adapted from the methodology handbook published by the Society for Healthcare Epidemiology of America (SHEA), September 2024. Rewritten in original language by The Clinical Database for educational and clinical reference purposes. ↩︎
ACCORD guideline for reporting consensus-based methods. Available at: https://www.equator-network.org/reporting-guidelines/accord/ ↩︎
Update to the CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) Recommendation Categorization Scheme for Infection Control and Prevention Guideline Recommendations. Centers for Disease Control and Prevention. ↩︎