The ACOG Clinical Consensus Methodology was developed by the American College of Obstetricians and Gynecologists’ Evidence Based Medicine Expert Work Group in collaboration with Jessica L. Butler, MPH; Valery A. Danilack, MPH, PhD, Nancy E. O’Reilly, MHS, and Christopher M. Zahn, MD.
Goals of ACOG Clinical Consensus Recommendations
Clinical Consensus documents detail an assessment of important clinical issues in obstetric and gynecologic practice. They are brief, focused documents of limited scope addressing emerging, urgent, or high-priority clinical screening, diagnosis, or management issues, structured around consensus-based recommendations. These Clinical Consensus documents are based on a careful examination of available scientific data, supplemented with expert opinion when the evidence is limited. Developed by the Committee on Clinical Consensus–Gynecology and the Committee on Clinical Consensus–Obstetrics, these documents are developed to optimize patient care by providing clinical recommendations on focused clinical issues.
ACOG’S Clinical Consensus Committees
The Clinical Consensus Committees select and outline new topics, identify authors, review and vote on proposed recommendations and supporting evidence for documents in development, finalize guideline manuscripts, and assess existing documents to ensure accuracy and currency. The committees are also responsible for topic prioritization, identifying content that is relevant for the target users, who are providers of gynecologic and obstetric care.
Committees consist of a chair and vice chair, approximately 20 full members (including members with subspecialty clinical expertise in adolescent care, infectious disease and immunization, health equity, genetics, family planning, reproductive endocrinology, urogynecology, gynecologic oncology, and maternal–fetal medicine). All full committee members are American College of Obstetricians and Gynecologists (ACOG) member volunteers and generally serve 3-year terms. Also included on the document development committee are a methodology consultant, two public members, ex officio members, and liaisons from external organizations. Ex officio members are representatives from internal ACOG committees or groups. Liaisons are invited representatives of organizations bringing a specific focus. Members of the committee understand the elements of evidence-based medicine methodology, with additional methodology training and committee orientation provided as part of committee service.
The public members provide a voice for those who receive health care from obstetrician–gynecologists and assist the committee’s decision-making process on a variety of women’s health care issues. Public members are selected because of their relevant experience and specific technical skills. Public members are not appointed to act as representatives of a particular advocacy organization or agenda. If members belong to stakeholder organizations, ACOG and the committee advise that they bring their own perspective to the group rather than solely conveying the views of their organization.
ACOG is committed to addressing health disparities, enhancing equality and diversity of input in all committee work 1. Both ACOG member and public member committee participants come from a wide range of backgrounds and experiences. ACOG encourages participation from a diverse range of backgrounds including race and ethnicity, gender, practice setting, geographic region, and clinical expertise.
Conflicts of Interest
ACOG relies on its volunteer committee leaders and members to avoid actual and potential conflicts of interest, as well as situations that may create the appearance of conflict of interest. ACOG expects committee members to use sound judgment and good faith in identifying actual and potential conflicts of interest, with the broad objective of disclosing any activity or position that may give rise to a conflict. In fulfilling their duties for ACOG, participating individuals must act in the best interests of ACOG and not in furtherance of personal or third-party interests and have an obligation to ensure that ACOG maintains a bias-free decision-making process and to avoid all potential conflicts of interest.
At least annually, each committee member must complete and submit a disclosure form detailing all financial (in excess of $100), business, or other interest in any company, organization, service, product, or other concerns that might affect or be affected by ACOG activities. In addition, the members must disclose all such interests held by their family members and business associates. If there are changes in an individual’s circumstances or the circumstances of his or her family members and business associations that require disclosure throughout the year, the disclosure form must be updated.
Disclosed information is provided to the Chief Executive Officer, the Chief Legal Officer, and relevant ACOG staff and shared with the committee leadership and members at each meeting. Any committee member who has an actual or potential conflict of interest in any subject related to material in development or under discussion will be removed from discussions and actions involving that subject. Committee members are responsible for ensuring recusal from discussions and may seek advice from ACOG’s legal counsel.
The preceding is only a summary of ACOG’s Conflict of Interest Disclosure Policy. For the full policy, please visit https://www.acog.org/-/media/project/acog/acogorg/files/pdfs/acog-policies/conflict-of-interest-disclosure-policy-for-staff-and-volunteers.pdf .
ACOG Clinical Consensus Document Development
Selection of Topics
Topics selected for development as a Clinical Consensus document are those deemed clinically important to the practice of obstetrics and gynecology, in particular, due to high incidence or prevalence of a condition or procedure, emergence of new or conflicting evidence, uncertainty in management, or significant variations in practice. Clinical Consensus topics have a narrow scope, with one to two focused clinical questions or issues that may lack consensus, be time sensitive, or be based on emerging evidence. A topic is chosen when recommendations are important for clinical screening, diagnosis, counseling, or management. Prioritization of new and pending topics is discussed and evaluated at committee meetings and includes consideration of topics already addressed by other medical organizations to avoid duplication of efforts and conflicting recommendations. Each committee selects new topics annually and may also update current documents based on new data.
Development of Manuscript
The development process typically spans 12–18 months from the initial topic selection to final publication. The process is led by two committee member authors who are responsible for developing the topic outline, reviewing and synthesizing relevant evidence, developing recommendations, and authoring the topic manuscript. The committee members who are appointed as authors have scheduled conference calls with ACOG staff and frequent electronic communication during document development.
Outline
The scope and purpose of a selected Clinical Consensus topic include identification of the key clinical areas, intended patient population, and known relevant literature to inform the clinical topic.
A formal topic outline with PICOTS (Population, Intervention, Comparator, Outcomes, Time, and Setting) elements for each key question is drafted by the committee authors and staff, with input from the chair and vice chair. Health equity considerations are incorporated into the outline and literature search using the framework outlined in the PROGRESS Plus tool 2 3 4 as a prompt for the outline and PICOTS. Clinical and methodologic experts may be consulted, and a scoping literature search may be conducted to identify the breadth of existing and relevant literature on the topic. The Clinical Consensus Committee reviews the proposed outline, revises as necessary, and provides final approval.
Literature Search
A comprehensive literature search is performed to identify literature in ClinicalTrials.gov , Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, MEDLINE, and PsychInfo, as appropriate. These literature searches are performed by a team of ACOG staff medical librarians and managed by using reference manager software. If the Clinical Consensus in development is a revision of a Committee Opinion or current Clinical Consensus document, references from the original document are reviewed as appropriate and included in the title and abstract review. A review of the uploaded title is completed by ACOG staff. Studies that do not meet the PICOTS criteria or are outside of the scope of the document are excluded.
Just before publication submission, a final supplemental literature search is performed to ensure any newly published highly relevant literature is evaluated for inclusion in the final document.
Evidence Review for Clinical Consensus
Study inclusion and exclusion criteria are developed by the authoring team members, committee leadership, and the methodologist. Based on these criteria, the titles and abstracts from the literature search results are screened by staff. Priority is given to high-quality systematic reviews, published evidence-based guidelines by clinical or public health organizations, randomized controlled trials (RCTs), and observational studies. A full-text review is completed by the authors to assess the studies that passed the title screen, based on the predetermined inclusion and exclusion criteria. Standardized reasons for article exclusion are documented. The development process does not involve a risk of bias analysis or grading of the evidence.
Once a final list of relevant studies and guidelines is identified by the authors, ACOG staff develop summary evidence maps. The evidence maps provide a concise display of the evidence supporting each clinical question and are organized by the hierarchy of evidence (ie systematic reviews, RCTs, observational studies, case studies, and narrative reviews). Guidelines from professional societies and other relevant stakeholders are also summarized. The writing team and committee use the supporting evidence summarized in the evidence maps when developing the full recommendation statements and descriptions of supportive evidence.
Development of the Recommendations and Manuscript
Authoring team members review the evidence included in the evidence maps, and from these, propose key recommendations. Clinical Consensus recommendations include a description of the relevant population, intervention, comparator, outcome, timing, setting, and dosing regimens as appropriate. When reviewing and evaluating the evidence, the authors consider information on benefits and harms, patients’ values and preferences, resource use, cost, effect on equity, and generalizability. The authors identify any evidence related to specific segments of the U.S. population that may be disproportionately or differentially affected by a condition and propose specific recommendations for this population based on the evidence review when possible. Any articles in the evidence map that are not cited in the draft manuscript undergo additional review. If after additional review it is determined that an article should not be included, the article is then removed from the evidence summary.
The recommendations are reviewed alongside the evidence maps by the full Clinical Consensus Committee. After a comprehensive discussion of each recommendation and supporting evidence with all committee members and liaisons, a formal committee vote is held for approval of each recommendation statement. Due to the nature of Clinical Consensus topics, evidence may be limited, and voting has been implemented as a means of ensuring consensus in the Clinical Consensus Committee. A quorum of two thirds of eligible committee members is needed to hold a vote. Any member with a conflict of interest that prevents them from voting on the topic will be subtracted from the total number of eligible voting participants. Eligible voting members include full committee members, young physician members, public members, and ex officio members. Liaisons are excluded from voting. A 75% approval threshold is needed to move a final recommendation forward. Proposed recommendations not meeting this threshold can be revised and reconsidered. Proposed recommendations that do not meet the threshold after a second vote are not incorporated into the Clinical Consensus.
Once agreed upon by the full committee, the final recommendations are used as the framework for manuscript development by the writing team. The supporting text includes a synopsis of the available evidence to support the recommendations, short statements on patients’ values and preferences, the balance of benefits and harms, and special health equity or implementation considerations where relevant. Once reviewed and verified by the writing team, the manuscript is reviewed and discussed by the Committee on Clinical Consensus during a scheduled meeting. A final manuscript, incorporating changes from discussion, is reviewed and approved by the Committee on Clinical Consensus before additional consideration from other internal review bodies.
Review and Approval of ACOG’S Clinical Consensus
Clinical Document Review Panel
Once approved by the Committee on Clinical Consensus, the manuscript is submitted to a Clinical Document Review Panel for review. This internal peer review panel is independent of the committee and serves to ensure that relevant evidence is included and accurately interpreted, and that the clinical recommendations are clear and implementable. This panel is composed of obstetrician–gynecologists who previously served as members on a clinical guidance committee and are therefore familiar with the document development process and have relevant expertise in clinical and evidence review and synthesis. They are provided with the manuscript and full evidence maps linked to the recommendations. Approval by the Clinical Document Review Panel is required.
Board of Directors Review
The final internal review is by the ACOG Board of Directors. The manuscript and recommendations and corresponding evidence maps are provided as part of the review. Once approved, the manuscript is submitted for publication in Obstetrics & Gynecology, ACOG’s peer-reviewed journal, and published on the College’s website, acog.org .
ACOG Clinical Consensus Update Process
In accordance with ACOG policy, each published ACOG clinical guidance document is reviewed by the originating committee every 24–36 months to assess its accuracy and continued relevance.
During this routine review of an ACOG clinical document, an assigned committee reviewer(s) is provided a literature search of relevant new evidence published since the Clinical Consensus was published or last reviewed, as well as ACOG’s related published guidance, any related correspondence, and key notes from previous committee reviews. A recommendation from the reviewer about the future disposition of the document (ie, reaffirm, replace, or withdraw) is discussed by the full committee, who have also had the opportunity to review these documents. A determination of the document’s status is agreed upon by the full committee after discussion.
Reaffirmed documents are deemed current and accurate and can remain in circulation until a replacement is issued or they become outdated. If the recommendations for clinical guidance would not change, reaffirmation is appropriate. Some revisions may be possible through issuance of a Practice Advisory, particularly if there is a landmark study published that requires a recommendation to be reconsidered.
Replacement of a document is recommended if the clinical issues are deemed still to be relevant but the document includes recommendations that may have changed since publication. A document can remain in circulation until replaced, or immediately be withdrawn.
A document is withdrawn from circulation if content is inaccurate or outdated, the content is seen as no longer relevant, or the subject is adequately addressed in other ACOG documents or by another medical organization. Generally, documents are immediately withdrawn only if there is an egregious inaccuracy or a serious issue with the content.
During a transition period, the Clinical Consensus Committees will also oversee existing clinical Committee Opinions. Review for these Committee Opinions will follow the above-described process for reaffirmation and withdrawal. However, if a replacement is warranted, the content will be redeveloped as a Clinical Consensus document.
DISSEMINATION
ACOG Clinical Consensus documents are available on the acog.org /clinical website and published in Obstetrics & Gynecology . Efforts are made to work with other ACOG Departments and Divisions to facilitate dissemination and implementation, particularly with strong consideration of advancing health equity. In addition, external organizational partnerships are sought that can facilitate broader dissemination, especially for communities that may be disproportionately affected by the health conditions addressed in the document.
Financial Support
Funding for the development of clinical consensus documents is provided by the ACOG operating budget. No other entity provides financial or other support.
Obstetric Care Consensus
The Obstetric Care Consensus series are documents jointly developed with the Society for Maternal-Fetal Medicine (SMFM). The development of these documents will follow similar methodologic processes to those of the Clinical Consensus series regarding the focus, literature review, and recommendation development, but will also include involvement of authors from SMFM, review by the SMFM Publications Committee, and grading of the recommendations according to the SMFM process.