A. Perspective

C. Template for Answering WikiGuideline Questions

D. Additional Sections to be Included

Section 2 - COI & Financial Considerations in Guidelines

A. Conflicts of Interest (COI)

B. Economic Considerations in Guidelines

Section 3 - Committees and Participants

A. WikiGuidelines Participants

B. WikiGuidelines Steering Committee

C. Drafting Committees

1. Hypothesis-confirming evidence is defined as based on ALL of the following:

• At least two controlled, prospective interventional clinical studies that are adequately sized/powere and have undergone peer-review and are publicly posted, including at a minimum:
  
• One properly conducted, adequately powered randomized controlled trial (RCT); AND
  
• At least one other prospective, controlled clinical study, either a second RCT, a quasi-experimental pre-post study, a pragmatic clinical trial, or a carefully conducted historically controlled study
  
• General consensus of the Drafting Committee that the above studies are valid, sufficiently generalizable, have a low risk of bias, and are without substantial flaws that preclude confidence in the conclusions relevant to the question being asked; in the event that a general consensus is not clearly established, a formal vote can be taken, requiring concordance from a supermajority (3/4) during a Drafting Committee meeting (see section 3.E) to confirm these conclusions.
  

• Totality of the evidence
  
• In assessing totality of the evidence to determine if it meets hypothesis-confirming standards, any discordance of available prospective study results should be considered
  
• Discordant results may still enable a totality summary to be considered hypothesis-confirming, if the discordance is a clear minority of the totality of data, and/or has a clear distinction in patient population from the majority data.
  
• In all cases, discordant data should be explicitly discussed in the body of the guideline.
  

2. Hypothesis-generating evidence is anything not meeting hypothesis-confirming definition—when there is dispute about the level of evidence, the WikiGuidelines will err on the side of calling the evidence hypothesis-generating so as to not overstate the quality of evidene.

3. Areas where more evidence is required will be highlighted to help prioritize future research.

1. Structure of Each Question Answered

• Questions to be answered will be selected by the Drafting Committee
  

Each answer will begin with a clearly delineated indication of whether the answer is a Clear Recommendation (defined in 1.C.2) or Clinical Review (defined in 1 C.3).

• The Clear Recommendation/Clinical Review will be followed by a 1 or 2 sentence consensus, summary answer.
  
• The consensus answer is followed by a brief Executive Summary, which ideally will be <300 words, but may be somewhat longer in unusual circumstances, if the Drafting Committee chooses.
  
• It is desirable to graphically illustrate the results of the prospective studies (e.g., via forest plots, summary tables, visual abstracts, etc), and these data summaries are placed below the Executive Summary.
  
• The Executive Summary/data figures/tables are followed by a broader discussion and synthesis of the literature with citations, leading to the conclusions from a totality of the evidence
  
• When possible, the broader discussion can include a section titled “Limitations of Data”, which will summarize important limitations that preclude extrapolation to other patients, and will also highlight areas of unmet need for future study.
  

2. Clear Recommendations

Clear Recommendations are written only when questions have been addressed by published hypothesis-confirming evidence (as defined in section 1.B)

• CLear Recommendations offer specific guidance, and therefore should use words like “recommended” or “not recommended”
  
• When the distinction between hypothesis-confirmatory and hypothesis-generating evidence is unclear, Clinical Reviews will be written instead of Clear Recommendations to avoid overstating the level of evidence.
  
• If during the drafting process, >25% of Drafting Committee participants disagree that the prospective studies can be used to meet hypothesis-confirming evidence criteria (e.g., due to flaws in study design, execution, study power, discordant studies, etc), the question should be answered as a Clinical Review
  

3. Clinical Review

• Clinical Reviews are written when the available evidence is hypothesis-generating (i.e., does not meet hypothesis-confirming standards as defined in section 1.B)
• Clinical Reviews do NOT offer definitive guidance, and should avoid words like “recommended”, “should”, “strongly preferred”, etc.
• Clinical Reviews focus on care choices, and typically discuss pros and cons and care options, using words like, “may”, “some clinicians prefer”, “in some cases”, “reasonable to consider”, “generally” etc.
• Clinical Reviews may take stronger language to recommend against taking action (e.g., “should not routinely”), due to the principle of “first do no harm”, which sets a lower bar for decisions not to take action than decision to take action
• Clinical Review sections begin with a statement that hypothesis-confirming evidence is not available to answer the question
• Clinical Reviews identify, as possible, areas where future research could allow for Clear Recommendations

4. General Rules Applicable to Both Clear Recommendations and Clinical Reviews

• For all answers, areas of disagreement among drafters and public commenters will be specifically acknowledged in the text, including the rationale provided, the specific context of disagreement, and a general assessment of how much disagreement existed among the Drafting Committee (e.g., approximately how many, or what proportion, believed one position or the other)
• In contrast to traditional guidelines, there is no assessment of the strength of recommendations offered—there is either a Clear Recommendation made, or a Clinical Review written
  

1. The Method section of all guideline documents will include caveat similar to: “WikiGuidelines evidence standards are summarized in its Charter. These guidelines are intended only to provide insight into the opinions of the participating clinicians, and are not intended to establish care mandates, serve as medical-legal standards of care, or to replace individual clinician judgment for individual patients.”

2. All guidelines documents will conclude with the additional caveat similar to: “These guidelines are based on published data available as of {list date of posting of the most recent guidelines}. Clinicians who believe other evidence should be considered may contact any of the authors to initiate possible revisions to the guidelines, which the authors intend to complete in close to real time. WikiGuidelines participants understand that no clinical trial can ever be extrapolated to all possible patient care scenarios. Thus, it is our explicitly stated expectation that these guidelines not be used to replace individual clinician judgment for individual patients.”

1. WikiGuidelines recognizes that there are both individual and specialty-level conflicts of interest, and that while individual-level conflicts of interest typically garner concern among guideline authors, the specialty-level conflicts may play an even greater role in affecting recommendations for care.
2. Specialty level COI will be addressed by attempting to include generalist participants at all levels of WikiGuidelines governance, including intentionally including them on Drafting Committees, and by focusing on generalists as the customer of the guidelines, incorporating considerations of High Value Care and Healthcare Quality, and avoiding physician professional fee billing considerations when assessing evidence (see section 1 for each of these).
3. Drafting Committee participants must disclose in the written guideline the total sum of private, third-party (i.e., not primary employers) financial payments or equity during the last 24 months that are related to the practice of medicine (disclosed as <$10,000 USD per year, or ≥$10,000 USD per year of equivalent value), and their degree, practice affiliation/title, geographical area of practice, and clinical specialty.
4. Individuals who have received ≥$10,000 USD equivalent value of funding from, or own that level of equity in, any third-party, for-profit source related to any given guideline topic (including funding to conduct research) may be asked by the Steering Committee to recuse themselves from participating in discussions and drafting any material related to the reimbursed matter.
5. All products (drugs, devices, etc) mentioned in the guidelines should be referred to by their generic name.
6. While not explicitly precluded, consideration should be given to whether individuals who are authors on specialty society guidelines should also be participants of Drafting Committees for the same conditions.
7. All disclosures of ≥$10,000 USD equivalent value and the position of authors on specialty society guidelines will be considered by the WikiGuidelines Steering Committee, who will recommend in line with the above principles the appropriate action regarding recusal from sections within guidelines or specific guidelines in whole. If the disclosures or position of a participant of the Steering Committee is being assessed, then that participant must recuse themselves from the discussion.
8. All disclosures, authorship on specialty society guidelines, and Steering Committee recommendations will be publicly disclosed on the WikiGuidelines website, the relevant guidelines, and the relevant guideline sections.
   

1. Considerations of the economic impact of the recommendations made in the WikiGuidelines is encouraged, consistent with the focus of the guidelines (e.g., system-based practice, opportunity cost, High Value Care, and Quality standards) per section 1.A.

2. Such considerations should include variations in the economic considerations (e.g., drug costs) and logistical considerations (e.g., availability) between countries.

3. When considering cost-efficacy analyses, WikiGuidelines will incorporate understanding that cost-efficacy does not equate to cost-reducing, that one party’s cost is usually another’s revenue (so is the perspective the healthcare system, the payer, the provider, etc.), and that cost-efficacy from the perspective of a societal payer is distinct from and frequently contradictory to the feasibility of implementation at the level of healthcare delivery.

4. Non-industry studies of cost-efficacy will generally be preferred to industry studies because of the vested interests present in the assumptions of value.

Section 1 - Guidelines Principles

A. Perspective

B. Evidence Standards

C. Template for Answering WikiGuideline Questions

D. Additional Sections to be Included

Section 2 - COI & Financial Considerations in Guidelines

A. Conflicts of Interest (COI)

B. Economic Considerations in Guidelines

B. WikiGuidelines Steering Committee

C. Drafting Committees

1. Eligibility for Participation
   
• Qualified practitioners in a relevant clinical field with an active professional license in good standing may participate as a guideline author.
  
• There is no limit to the number of practitioners who may participate in a guideline.
  
• Sll new participants should provide a copy of their CV and attest that their professional license remains active and in good standing.
  
• WikiGuidelines will require all prospective authors for soon to be published guidelines to verify their professional license remains active and in good standing.
  

Section 1 - Guidelines Principles

A. Perspective

B. Evidence Standards

C. Template for Answering WikiGuideline Questions

D. Additional Sections to be Included

Section 2 - COI & Financial Considerations in Guidelines

A. Conflicts of Interest (COI)

B. Economic Considerations in Guidelines

A. WikiGuidelines Participants

C. Drafting Committees

1. Responsibilities

• Select topics to focus on for new guideline documents.
  
• Select Chair and if desired Co-Chair of the Drafting Committee for each guideline by consensus, and if no consensus is achieved, by majority vote.
  
• Give final approval by consensus, or by majority vote only in the absence of consensus, to the first draft of each WikiGuideline before it is publicly posted.
  
• Authorize posting of updates of previous guidelines by majority vote.
  
• The Chair of the Steering Committee will serve as a liaison to the Board of Directors, attend Board meetings when asked, and provide regular updates to the Board regarding guideline activities.
  

2. Participants

• Members of the Steering Committee will be selected by the Board of Directors.
  
• Steering Committee participants will serve 3-year terms, without term limits.
  
• The Steering Committee will elect a Chair from among its participants by majority vote.
  
• Once selected, the Chair may be changed during the three-year term of service by a super-majority (>3/4) vote of the Steering Committee, or a majority vote of the Board of Directors.
  
• Steering Committee participants may be removed for cause, including ethical breeches or failure to carry out Steering Committee responsibilities, based on a majority vote of the Board of Directors.
  

3. Meetings

• Steering Committee Meetings will be called by the Chair, or based on a motion from any two participants of the Committee or at the request of the Board of Directors.
  
• Meetings may be held by in person, web-access or phone, or by email.
  
• Meeting motions may be made by email to the group.
  
• A quorum for meetings will require the Chair and at least 4 other of the 7 participants (total 5 participants).
  
• The agenda for the meeting will be prepared in advance by the Chair.
  
• Any participant, including the Chair, may make motions.
  
• Each participant has 1 vote.
  
• Committee decisions will generally be by consensus, but if there is disagreement, a majority vote will be required.
  
• Votes will be counted among participants participating in the specific meeting, as long as a quorum is met, with non-participating participants marked as absent and their votes counted is if abstained (not counted in either numerator nor denominator).
  

1. Participants

• For each topic selected by the Steering Committee, a separate Drafting Committee will be established.
• Drafting Committees may be constituted of any number of participants.
• Each Drafting committee will have 1 Chair or 2 Co-Chairs, selected by the Steering Committee.
• The Chair and/or Co-Chair will identify and select Drafting Committee participants.
• Participants may be removed by a super-majority vote (3/4) of the Drafting Committee, or by a majority vote of the Steering Committee or Board of Directors.

2. Responsibilities

• The Chair/Co-Chair will identify questions and 1 or 2 leads for each question/sub-section of the guideline.
• The Chair and Co-Chair (if there is one) will generally be listed as the first and senior author on the finished guideline.
• The lead(s) of each question is responsible for coordinating with participants to create the first draft of their sub-section of the guideline.
• In return for added responsibility, leads will be prioritized on the author list of the final manuscript.
• The participants are responsible for conducting literature searches, drafting, and revising each question/sub-section for which they have volunteered.
• The lead(s) of each question is responsible for providing to the overall Chair/Co Chair a finished first-draft section by the deadline specified by the Chair/Co-Chair.
• The Chair/Co-Chair will work with the lead(s) to incorporate that first draft into the overall first draft of the larger guideline.
• All participants will then be asked to review and revise the entire guideline.
• The lead(s) will be responsible for incorporating revisions into their question.
• The Chair/Co-Chair will be responsible for finalizing the entire, overall manuscript, and submitting it to the Steering Committee for any final revisions and final approval.
• All participants of the Drafting Committee are expected to contribute to conceptualization and drafting of the guideline document, and to be willing to be responsible for the entire content of the document, even sections that they did not write or contribute to, in accord with ICJME standards for publication authorship criteria.
• Once posted, the Chair/Co-Chair will be responsible for curating the guideline, and working with the section lead(s) and participants to update the guideline.
  

WikiGuidelines is an international, not-for-profit, crowd-sourced approach to the development of guidelines.

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