Methodology

The Endocrine Society’s guideline development process combines elements of the GRADE framework (1) with, when relevant, an approach believed to be appropriate for rare endocrine diseases where scientific evidence is limited or non-existent. The Society applies the steps in the GRADE framework to research questions for which there is an ample body of knowledge of low quality or higher (see Table 1). In these situations, GRADE provides the methodological and statistical rigor which results in robust recommendations which are classified using quality of evidence and strength of recommendation as described in by Guyatt et al. (2) and also represented graphically in Table 1.

Where evidence is extremely limited and/or not systematically analyzed, we provide recommendations based on an expert review of the limited data. This process is less systematic than the GRADE methodological framework, however, these recommendations are also clearly classified using the GRADE classification system.

Some of the Society’s clinical practice guidelines also include Ungraded Good Practice Statements (3). This unclassified clinical guidance can include expert opinion statements on good practice, references to recommendations made in other guidelines, and observations on preventive care and shared-decision-making.

Guideline recommendations include the relevant population, intervention, comparator and outcome. When further clarification on implementation is needed, we include Technical Remarks. These provide supplementary information such as timing, setting, dosing regimens, and necessary expertise. All recommendations are followed by a synopsis of the evidence which underpins it. Authors may also include short statements on patients’ values and preferences, the balance of benefits and harms, and minority opinions, where relevant.

It should be noted that the Society’s guideline development process is currently under review and new approaches and processes are likely to be instituted in the coming months.

GRADE Classificattion


Funding

Funding for the development of guidelines is provided by the Endocrine Society. No other entity provides financial or other support.


Conflict of Interest

The Endocrine Society’s conflict of interest (COI) rules for the development of clinical practice guidelines are summarized as follows:

  1. To be considered for membership of a Writing Committee (WC), nominees are required to disclose all relationships (and all known immediate family members) for the 12-month period prior to guideline Writing Committee initiation. This is consistent with the reporting timeframe for the National Institutes of Health and the Food and Drug Administration.
     
  2. Potential conflicts of interest that should be declared include all relationships with commercial, non-commercial, institutional, and patient/public organizations. This includes employment, consultancy, interests in start-up companies and/or in those where stock is not publicly traded, ownership interests in publicly-traded companies such as stock options (excluding indirect investments through mutual funds), research funding directly paid to the individual, research funding paid to employer organization or other research institution with whom the individual is involved, serving as a Principal Investigator, honoraria, royalties, paid or unpaid expert testimony, speaking engagements, speaker’s bureaus, etc.  Leadership positions and memberships of other entities (paid and unpaid) including Data Standards Monitoring Boards, non-profit or for-profit advisory boards and committees must also be disclosed. 
  3. Review of COI information is conducted as follows:

    a. WC Chairs: The Clinical Guidelines Committee (CGC) Chair reviews all COI information and determines whether any relationship represents a potentially relevant conflict of interest. The CGC Chair’s final recommendations are submitted to Endocrine Society Council for approval.
    b. WC Members: The WC Chairs review all COI information and determine whether any relationship represents a potentially relevant conflict of interest. Decisions on the relevance of relationships/conflicts to each guideline topic/section—in addition to the overall acceptability of a candidate’s COI—will be made by the WC Chairs in collaboration with the CGC Chair, who will have veto power.

  4. Optimally, the Society’s guideline Writing Committees (WC) would only include members who are free of COIs relevant to the topic of the guideline. The Society strives to achieve this ideal whenever possible.

    a. The Chair and Co-Chair of the Writing Committee must be free of any COI or other biases that could undermine the integrity or credibility of the work.
    b. A majority (>50%) of the Writing Committee members must be free of relevant COI.

  5. Writing Committee members with relevant COI are required to declare the situation and recuse themselves from any relevant discussions, votes, and from drafting recommendations. 
  6. All Writing Committee members are prohibited from adding new relevant industry relationships throughout the guideline development process, until publication.  If a new relationship is added, the CGC chair and WC chairs must determine whether the relationship represents a relevant COI and whether/how that COI should be managed. 
  7. If a relevant COI exists, it will be managed as follows:

    a. Disclosure:
    i. Following initiation of the committee, members are asked to disclose relationships with industry at every in-person meeting and on most conference calls.
    ii. If a member is aware of another person who might have a conflict and has not declared it for some reason, they are obliged to bring this to the Writing Committee Chair’s attention.

    b. Divestment:
    i. Members of the WC (and their immediate family members) must divest themselves of direct financial investments with entities that may have a potential financial interest in the contents of the guideline.
    ii. WC members must also refrain from participating in the marketing activities or advisory boards of such entities.

    c. Recusal:
    i. WC members are prohibited from drafting guideline sections directly related to her/his COI.
    ii. WC members are prohibited from determining the strength and direction of a recommendation directly related to her/his COI.
    iii. WC members are prohibited from voting on matters directly related to her/his COI.

    d. Transparency:
    i. The Society will include details of all relevant conflicts of interest of members of the WC in a detailed table within the published guideline.
    ii. More detailed COI documentation will be made available as needed in the form of supplemental materials (available online).

Please reference the full policy for more detailed information here.


Bibliography

  1. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, Norris S, Falck-Ytter Y, Glasziou P, deBeer H, Jaeschke R, Rind D, Meerpohl J, Dahm P, Schünemann HJ. GRADE guidelines: 1. Introduction - GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011; 64:383-394
  2. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann HJ. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336:924-926
  3. Guyatt GH, Schunemann HJ, Djulbegovic B, Akl EA. Guideline panels should not GRADE good practice statements. J Clin Epidemiol 2015; 68:597-600
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