Guideline Development Process

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.

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 as follows:

  1. To be considered for membership of a Writing Committee, nominees are required to disclose all relationships with industry for the 12-month period prior to guideline Writing Committee initiation. This is consistent with the reporting time-frame 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 that are (or may be) pertinent to the scope of the guideline.
  3. The chair of the Clinical Guidelines Subcommittee reviews all disclosed relationships and determines whether they are relevant to the topic of the guideline and present a potentially relevant conflict of interest.
  4. The chair of the Clinical Guidelines Subcommittee selects Writing Committee Chairs, Co-Chairs, and members based on the COI information received and the individuals’ expertise and other skills. Endocrine Society Council then reviews and endorses the nominees or makes appropriate changes.
  5. 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.
  6. At least half (≥50%) of the Writing Committee members must be free of relevant COI.
  7. Following initiation of the committee, members are asked to disclose relationships with industry at every in-person meeting and on most conference calls.
  8. Writing Committee members with relevant COI are required to declare the situation and recuse themselves from any relevant discussions, votes, and from drafting recommendations.
  9. All Writing Committee members must refrain from adding new relevant industry relationships throughout the guideline development process.
  10. 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.
  11. Staff, Writing Committee Chairs and members must be alert for situations which might present a potential or perceived conflict of interest.

GRADE Classificattion

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