Requirements for Submission of Organizational Guidelines

Organizational guidelines add tremendous value to the overall medical literature and represent quality scholarship that should be available to the scientific community. Such guidelines carry particular clinical authority, and their integrity depends upon the rigor with which they are developed, reviewed, and reported. The Editorial Board of ILM JAHM has adopted the following requirements for the submission of guideline documents.

All organizational guidelines accepted for publication in ILM JAHM are published under the Open Peer Review designation. Unlike manuscripts subject to standard double-anonymized peer review, guidelines submitted under Open Peer Review are evaluated by the Editorial Board with the identity of the authoring organization disclosed. This designation reflects the collaborative and transparent nature of guideline development while preserving the journal’s commitment to scholarly rigor.

1. Identification of Primary Authors

The submission must identify the primary authors: those members of the committee who meet all four ICMJE criteria for authorship. Authors must satisfy each of the following:

ICMJE Authorship Criteria

1.     Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work;

2.     Drafting the work or reviewing it critically for important intellectual content;

3.     Final approval of the version to be published;

4.     Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

All those designated as authors should meet all four criteria. Those who do not meet all four criteria should be acknowledged rather than listed as authors.

Full citation: ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, p. 2 (“Who is an Author”). Available at:

 https://www.icmje.org/icmje-recommendations.pdf

All reviewers of the submitted guideline must be identified by name and institutional affiliation. The submission must also include a brief description of each reviewer’s relevant expertise. The following minimum standards apply to the review process:

  • A minimum of three reviewers is required for each guideline submission.
  • At least one reviewer must be external to the authoring organization and must have no affiliation with the committee that developed the guideline.
  • Reviewers must hold relevant clinical, scientific, legal, or ethical expertise pertaining to the subject matter of the guideline.
  • All reviewers are subject to the same competing interest disclosure requirements as authors (see Section 3).
  • The submission must describe whether reviewers had an opportunity to respond to author revisions, and whether any reviewer objections remain unresolved.

ILM JAHM Competing Interest Policy

ILM JAHM requires disclosure of both financial and non-financial competing interests for all authors and reviewers of guideline submissions. Disclosures must be submitted at the time of manuscript submission. If a competing interest is identified or arises after submission, the corresponding author must notify the editorial office promptly. Competing interest disclosures will be reviewed by the Editorial Board; a declaration of competing interests does not assume bias, nor is it automatically grounds for rejection.

Definition of Financial Competing Interest

ILM JAHM defines a financial competing interest as any relationship that an author or reviewer holds which offers the potential for monetary gain or loss for that individual or a close family member based on the outcome of their contribution toward this particular manuscript. This includes, but is not limited to, income, capital appreciation, gifts, speaking fees, consulting fees, bonuses, royalties, or other compensation received from any entity with an interest in the outcome of the guideline.

Definition of Non-Financial Competing Interest

ILM JAHM defines a non-financial competing interest as any relationship that an author or reviewer holds which offers the potential for significant gain or loss for an entity or organization in which that individual has a relationship of employment, volunteer service, or other close involvement, and which entity or organization has the potential for gain or loss depending on the outcome of their contribution toward this particular manuscript.

The submission must include a description of the process by which the guideline was reviewed and formally approved by the authoring organization. At a minimum, this description should address the following elements:

  • The composition of the development committee and its relationship to the authoring organization’s governance structure
  • The formal process by which the guideline was approved for submission, including whether a vote, consensus process, or other mechanism was used
  • Whether the guideline was subject to a period of public or member comment prior to finalization
  • Whether the guideline supersedes, updates, or conflicts with any previously published guidance from the same or other organizations, and if so, how those conflicts are addressed
  • The date on which the evidence review was completed and the guideline was finalized

Guidelines should also specify the date range of the literature reviewed and include a statement regarding the organization’s policy for periodic review and update of the guideline. Guidelines based on evidence that may change significantly over time should specify a planned review date.

The submission must include a description of the methodology used to identify and select the evidence cited in the guideline. This description should address:

  • The databases, sources, and search strategies used to identify relevant literature
  • The inclusion and exclusion criteria applied to the literature, including date range, study design, language, and population
  • The rationale for any departures from systematic review methodology, including reliance on expert consensus in the absence of adequate published evidence
  • Whether the evidence review was conducted by the development committee, an independent methodologist, or both

Guidelines based primarily or exclusively on expert consensus must explicitly state this limitation and explain why the available evidence was insufficient to support evidence-based recommendations. Such guidelines are not precluded from publication but must be transparent about the basis for their recommendations.

All recommendations in the guideline must be accompanied by an explicit rating of the quality of the supporting evidence. ILM JAHM adopts the following four-level evidence quality framework for this purpose:

Level

Designation

Description

A

High Quality

Evidence from multiple well-designed randomized controlled trials or systematic reviews with consistent results. Low risk of bias.

B

Moderate Quality

Evidence from well-designed cohort or case-control studies, or RCTs with methodological limitations. Some risk of bias.

C

Limited Quality

Evidence from observational studies, case series, or expert consensus. Significant risk of bias or limited generalizability.

D

Expert Consensus Only

No adequate clinical evidence available. Recommendation based solely on expert opinion, clinical experience, or first principles.

In applying this framework, the Editorial Board notes that formal evidence level alone does not determine the appropriateness of a recommendation. The quality of evidence must be evaluated in the context of the severity and nature of the condition being addressed. Specific considerations include:

  • Multiple large randomized trials with biased design may still qualify as Level A; a single small but rigorously designed crossover study may provide more definitive evidence than multiple larger trials with confounded designs.
  • Use of a lower-evidence therapy may be justified for life-threatening conditions with extremely poor prognosis (e.g., advanced metastatic malignancy) where higher-evidence alternatives are unavailable.
  • Conversely, where the condition being addressed is mild or self-limiting, higher levels of evidence are required before recommending intervention.
  • Where the condition being treated is a normal physiologic state (such as pregnancy), the highest level of evidence is required to justify any intervention, and the evidence must demonstrate that the proposed treatment carries a safety profile with virtually no associated risks.

The evaluation of the risk/benefit ratio for any treatment recommendation requires two assessments: first, the risk of morbidity from the underlying condition without treatment; and second, the risks associated with the proposed treatment or intervention. ILM JAHM recommends use of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE v.5) to characterize both dimensions of this assessment on a consistent scale.

NCI CTCAE Severity Grades

Grade 1 — Mild:  Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2 — Moderate:  Minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living.

Grade 3 — Severe:  Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care Activities of Daily Living.

Grade 4 — Life-Threatening:  Urgent intervention indicated.

Grade 5 — Death:  Death related to adverse event.

The CTCAE scale should be applied first to characterize the severity of morbidity from the untreated condition, and then to characterize the severity and frequency of adverse events associated with the proposed treatment. A recommendation is considered clinically justified when the severity of treatment-associated adverse events is less than the severity of untreated disease morbidity — or, where severities are comparable, when the frequency of treatment adverse events is demonstrably lower than the frequency of untreated disease morbidity.

The following worked example illustrates the application of this principle: if an untreated condition produces Grade 1 morbidity only, no intervention is actually required, and any proposed treatment would need to demonstrate a safety profile correspondingly close to Grade 0. If, however, the untreated condition produces Grade 4 morbidity, treatment-associated adverse events of up to Grade 4 severity may be acceptable — provided the frequency of such events is lower than the frequency of Grade 4 events associated with the untreated disease.

Reference: NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Available at:

 https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events/ctcae-v5-5×7.pdf

ILM JAHM requires that all treatment recommendations in organizational guidelines be reported using the following classification rubric, adapted from Greenland et al. (2010). Each recommendation must be assigned a Class designation based on the risk/benefit assessment conducted under Section 7, and must be accompanied by the corresponding standardized language.

Class

Risk-Benefit Assessment

Recommended Language

I

Benefit >>> Risk

Treatment or intervention SHOULD be performed.

IIa

Benefit >> Risk

It is reasonable to perform treatment or intervention.

IIb

Benefit ≥ Risk

Treatment or intervention may be considered.

III

Benefit < Risk

Treatment provides no benefit or possible harm. Intervention should NOT be performed.

Each recommendation should also be paired with the evidence quality level assigned under Section 6, so that readers can evaluate both the direction of the recommendation (Class) and the strength of the evidence supporting it (Level). For example, a recommendation may be reported as: “Class I, Level A” or “Class IIb, Level C.”

The purpose of this classification is to provide clinicians, policymakers, and patients with a clear, consistent, and transparent basis for evaluating guideline recommendations. Recommendations should reflect the full risk/benefit analysis described in Section 7, and the rationale for each class designation should be stated explicitly in the guideline text.

Adapted from: Greenland P, et al. 2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults: Executive Summary. J Am Coll Cardiol. 2010;56(25):2182–2199.

Where a guideline is authored by one organization but formally endorsed by one or more additional organizations, the submission must:

  • Identify all endorsing organizations by full name in the byline and in the manuscript text
  • Include competing interest disclosures from the designated representatives of each endorsing organization
  • Describe the process by which endorsement was granted, including whether endorsing organizations had the opportunity to review and comment on the guideline prior to endorsement

Where the submitted guideline supersedes, updates, or conflicts with a previously published guideline from the same or another organization, the submission must explicitly identify the prior guideline(s) and explain the basis for any departure from or modification of prior recommendations.

Submit an Organizational Guideline Below

Org Guideline Submission

1. Authors

Does this author have any competing interests specific to this manuscript topic?

2. Reviewers

Does this reviewer have any competing interests specific to this manuscript topic?
Does the guideline contain an overview of the review and approval process?
Does the guideline contain a section addressing the methodology of selection of the papers reviewed?
Does the guideline contain a section rating the quality of the evidence?
Does the guideline contain a section evaluating the risk/benefit ratio for treatment??
Does the guideline contain a reporting of recommendations?
Does the guideline contain a section explaining endorsement, co-authorship, and relationship to prior guidelines?

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