Abstract
Background:
The American Thyroid Association (ATA) is continually striving to improve the quality of its publications. The ATA Guidelines Policies and Procedures Task Force was active during 2017. It recently recommended convening a formal standing committee to review and update policies and procedures for the development of clinical practice guidelines (CPGs) and Statements on an ongoing basis.
Objective:
This statement reviews the history of official ATA publications and discusses the challenges and findings identified by the Task Force. We also wish to present our “work in progress” and propose future directions for the new ATA Guidelines and Statements Committee (ATA GSC).
Methods:
Our Task Force reviewed the publication record of the ATA with respect to CPGs. We also reviewed existing ATA policies for CPGs and other official statements, examined policies of other organizations, solicited input from external experts and organizations, and convened five conference calls and two in-person meetings.
Results:
The ATA has a rich history of developing official publications that have been influential based on download and citation records as well as changes in practice trends. Key future issues to be further addressed by the ATA GSC include the following: (i) striving to improve the methodologic rigor of development of CPGs while balancing considerations of feasibility and timeliness and the role of transparently communicated expert opinion; (ii) formalizing a framework and process for development of new Statements; (iii) increasing stringency and transparency of management of competing interests of individuals being considered for CPG/Statement panel membership; (iv) encouraging consideration of equity and diversity in CPG/Statement development group composition; (v) increasing relevant stakeholder representation (including patient representatives) in development of CPGs/Statements; and (vi) expanding future guideline implementation strategies.
Conclusions:
As shown by the completed literature search, the ATA has a long history of producing CPGs and Statements with global impact on informing clinical management, education, and research in thyroid diseases. The ATA remains committed to a process of continual improvement of its publications and to meeting stakeholder information needs. Based on the work of our Task Force, we have identified many elements that are needed to achieve this goal and areas of challenge for our new committee.
Introduction
T
The ATA has a long history of developing CPGs and Statements, dating as far back as 1931, when the organization was referred to as the American Association for the Study of Goiter. The ATA continues to strive to improve the quality of its CPGs and statements and recently established its first ATA Guidelines Policy and Procedures Task Force to inform the planning of future clinical practice guidelines and statements. This Task Force was charged with providing guidance on standardization of methods for the development of CPGs and Statements for the organization. After nine months of activity, this Task Force recommended the formation of a standing committee to provide ongoing guidance regarding ATA guidelines and statements. We summarize in this document some of the past context, current findings and challenges, and proposed future directions for the newly constituted and commissioned ATA Guidelines and Statements Committee (ATA GSC).
Methods
We searched for documentation of prior ATA-sponsored CPGs and Statements using the following sources: an electronic database search, internal ATA records, and ATA website listings. Electronic searches of PubMed and EMBASE were conducted from inception until December 2017, by an information specialist librarian (J.H.). The following terms were used in the electronic search: American Goiter Society, American Thyroid Association, guideline, statement, consensus statement, position paper, policy statement, research statement, and workshop or conference statement. Hand searches also were conducted in an effort to capture nonindexed articles (2). In the hand search, the authors reviewed all pages of the ATA website, all electronic records of prior guidelines and statements retained by the ATA (courtesy of Bobbi Smith), and queried historical documents and society proceedings for information on any additional relevant documents. Data on downloads and citations of documents have been provided by Mary Ann Liebert, Inc., publishers, New Rochelle, NY, and Patricia Smith and Kristi Homes, Galter Health Sciences Library, Feinberg School of Medicine, Northwestern University, Chicago, IL. Both Scopus and the Web of Science were utilized for citation analysis. For simplicity in this document, each individual CPG publication is referred to in the singular, as a CPG.
Since January 2017, our Task Force has reviewed existing ATA policies, policies of other organizations, sought input from external experts and organizations, engaged in a dialogue with representatives of the National Guidelines Clearinghouse, and convened five conference calls and two in-person meetings. The Task Force co-chairpersons (J.J. and A.M.S.) formally presented the preliminary findings of the group to the to the ATA Board of Directors at the Annual Meeting of the ATA in Victoria, British Columbia, Canada on October 18, 2017. The Board of Directors provided verbal feedback, primarily relating to feasibility considerations. A written Guidelines and Statements Policy and Procedures document was developed by the Task Force, discussed among the group members, and then revised, incorporating additional input from all Task Force members and some members of the Board of Directors. This internal policy document was submitted to the ATA Executive Committee on December 1, 2017, has been reviewed by the ATA Board of Directors, and will be revised by the GSC in 2018. This discussion summarizes some of our findings and provides an update of our work in progress, as our policies and procedures continue to be reevaluated and updated. Some of the relevant topics being addressed by the group are presented here, to update ATA members and relevant stakeholders on our progress.
Results
ATA Record of CPG and Statement Publication Through 2017
Between 1931 and 2017, the ATA has published at least 34 CPGs (Tables 1 –4) (3 –46). The earliest identified CPG was authored by Dr. Van Meter in 1931 as a work product of the Committee on Goiter Classification and Nomenclature (3). The most recent CPG, co-chaired by Drs. Alexander and Pearce and published in 2017, was the second CPG addressing thyroid dysfunction during pregnancy (45). The ATA also has published at least 22 Statements (Table 5) (47 –72). The earliest identified Statement was published in 1977 by Gorman et al., examining a potential relationship between thyroid hormone and breast cancer development (47 –49). The most recent Statement, published by Leung et al. in 2017, addressed the role of potassium iodide in nuclear emergencies (72). A review of the topics encompassed by these CPGs and Statements illustrates a wide diversity and the far-ranging expertise of ATA members. Each ATA CPG resulted in at least four additional publications discussing, debating, or applying the CPG recommendations or contrasting the CPG with those issued by another professional society. The conclusions reached in ATA Statements have been validated (73), for example in the case of refuting an association between thyroid hormone replacement and breast cancer (47 –49). Thus, it is apparent that ATA CPGs have played a pivotal role in inspiring a rich body of scholarly literature. The number of downloads and citations received by 9 of the 10 ATA CPGs published since 2012 are illustrated in Figure 1. The data regarding downloads was collected on December 11, 2017 and the dates of completion of the Scopus and Web of Science citation analyses were December 21, 2017 and December 22, 2017 respectively. The citation data for selected official ATA publications are shown in Table 6. As has previously been reported (74), the citation numbers were higher when Scopus was used as the database, compared with use of the Web of Science. Currently the most cited ATA CPG is the 2009 Thyroid Cancer Management Guidelines (32) authored by Cooper et al., which has been downloaded 118,460 times and received 1440 citations. Furthermore, the 2015 Thyroid Cancer Guidelines have already been downloaded 473,758 times, exceeding downloads of the prior guideline iteration. Both the 2009 and 2015 Thyroid Cancer Management Guidelines have been downloaded throughout the world, with data for selected regions shown in Table 7.
Timeline, downloads, and citations of most recent American Thyroid Association guidelines (published 2012–2017).
All guidelines above predated the routine documentation of conflict of interest (COI), utilization of systematic reviews, and grading of recommendations.
Female chair(s)/lead author(s).
F, females; M, males.
Female chair(s), lead author(s).
USPSTF, United States Preventive Services Task Force.
Female chair(s), lead author(s).
ACP, American College of Physicians; AACE, American College of Clinical Endocrinologists; GRADE, Grading of Recommendations Assessment, Development, and Evaluation.
Female chair(s), lead author(s).
Female chair(s), lead author(s).
Gray shading indicates over 1000 citations.
Data as of December 26, 2017, for selected regions of the world.
Agencies Relevant to Future ATA Guideline Development
Development of CPGs is a key priority for the ATA. Three agencies are of particular relevance to these future activities.
(i) Institute of Medicine
The Institute of Medicine, now known as the United States National Academy of Sciences, Engineering, and Medicine (abbreviated as IOM for simplicity), currently defines CPGs as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” (75). In 2011 the IOM published eight standards for the development of CPGs (75). These standards are focused on the following concepts: (a) establishing transparency of the development process (i.e. methods), (b) management of competing interests, (c) composition of the guidelines development group (GDG), (d) the intersection between CPGs and systematic reviews, (e) establishing evidence foundations and rating the strength of recommendations, (f) standardized wording of recommendations, (g) external review of CPGs, and (h) documentation and process of updating CPGs (75).
(ii) Guidelines International Network
Soon after publication of the IOM standards, the Guidelines International Network (GIN), representing guideline developers, suggested that the list of standards developed by the IOM could be considered aspirational, but was not feasible to follow in its entirety (76). GIN developed its own standards for promoting improvement of CPGs, while recognizing that some variations in approaches would be “inevitable and appropriate” (76). Key components of the GIN standards include concepts similar to the IOM standards, including transparency of reporting of methods, managing competing interests, GDG composition, use of systematic review methods, clear articulation of recommendations (considering benefits, harms, and, if possible, cost), rating of evidence and recommendations, and established, clearly reported updating procedures (76). Additional GIN standards, include: a clear description of the scope of the CPG, an established, clearly reported method of consensus development, and disclosure of any financial support for the evidence review and CPG recommendations (76).
(iii) National Guidelines Clearinghouse
Another agency with major influence in informing standards for CPG development is the National Guidelines Clearinghouse (NGC), which is sponsored by the Agency for Healthcare Research and Quality through the U.S. Department of Health and Human Services (77). The NGC mission is “to provide physicians and other health care professionals, health care providers, health plans, integrated delivery systems, purchasers and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use” (78). The NGC currently manages a repository of CPGs, meeting the organization's specific standards. As of the time of writing this document, there is uncertainty regarding the future of the NGC and its repository, due to some proposed changes in federal infrastructure and funding. Our Task Force is grateful to the NGC representatives for their helpful advice regarding ATA CPG policy development.
Application of Agency Standards to the Ata
The ATA is committed to continually improving the quality of its CPGs and striving to achieve the standards established by the IOM (75) and GIN (76). Key elements of the IOM and GIN standards that are of relevance to the ATA, along with the challenges that these standards pose, are summarized below.
Funders and industry have not had any role in ATA CPG or Statement development since 2005, and this will remain the case going forward. Consistent with the GIN standard (76), any financial support for evidence reviews and guideline recommendations must be reported in the document. The ATA acknowledges that COIs among CPG panelists is common (79,80), and also may occur among organizations sponsoring CPGs. For example, Neuman et al. have reported that 52% of GDG members on American and Canadian CPGs had COIs (79), which is likely a reflection of the content expertise of many such individuals. Balancing content expertise and COIs of GDG/SDG members is likely to pose some challenges for the ATA, as it has for many other organizations. However, the ATA is committed to transparency of process and declaration of all relevant COIs for GDGs and SDGs. The evolution and increased awareness of the need for documentation of COI can be illustrated by review of the characteristics of CPGs and Statements seen in Tables 1 –4 and Table 5, respectively. We have developed a three-part form for vetting of COI. Part 1 of the form involves the self-declaration by the prospective GDG or SDG member and part 2 of the form documents the review by the GDG or SDG chairperson. If there is a COI, then part 3 of the form documents further review with vetted members of the GDG or SDG, with documentation of whether the COI can be managed or not. The method of management of the COI is also documented.
Data as of November 3, 2017.
The ATA is also committed to encouraging gender equity and diversity of GDG/SDG membership. In reflection of its membership profile, the ATA's goal is for approximately half of the GDG/SDG membership to be female. Gender equity is important for planning the composition of GDGs (81), and is particularly poignant for the ATA, given that thyroid disease is more prevalent in women than men. The gender composition of prior ATA CPG and Statements is shown in Tables 1 –4 and Table 5. It is apparent that there is a trend over time towards a composition that better reflects the composition of the ATA (Table 8) by increasing inclusion of women.
The ATA also encourages the development of Statements, which are supplementary documents intended to complement ATA CPGs. Although use of systematic reviews is not mandated for development of Statements, the methods used, including details of achievement of consensus, must be reported within the document. Some examples of Statements include policy statements/declarations, research reports, consensus statements, workshop or conference reports, technological or procedural declarations, and rapid response statements. The ATA recognizes the important contribution of other organizations such as the American Thoracic Society in establishing a taxonomy and methodology for developing Statements (83), and similar approaches for some Statement types has been adapted by the ATA.
Conclusion
The Task Force members recognize the creative wealth of CPGs and Statements that have been developed over the years by dedicated ATA members, committees, and task forces. These publications have contributed to advancements in the field and stimulation of new research. Here, the Task Force has summarized some of the work in progress, as the ATA, in part through future activities of the ATA GSC, strives continually to improve the quality of its official publications, including CPGs and Statements. Some of the processes described in this document may be implemented sooner than others due to feasibility considerations and the existing limitations in resources and expertise. Additional policies and procedures will be developed for several important issues, including strategies for dissemination and implementation of CPGs. The ATA welcomes feedback from its members, patients, stakeholder users of their guidelines, and the larger public.
Footnotes
Acknowledgments
The Task Force members would like to acknowledge the inspiration and wisdom provided by ATA board liaison Dr. Victor Bernet. The expert guidance and assistance provided by ATA staff liaisons Bobbi Smith and Sharleene Cano is also greatly appreciated. Special thanks to Vicki Cohn, Mary Ann Liebert, Inc., publishers, New Rochelle, NY, and to Patricia Smith and Kristi Holmes, Galter Health Sciences Library, Feinberg School of Medicine, Northwestern University, Chicago, IL, for providing download and citation data for Thyroid. Thank you also to Jonathan Hartmann, MLS, Senior Clinical Informationist, Head of Data Management, Dahlgren Memorial Library, Georgetown University, Washington, DC, for conducting literature searches for this manuscript.
The authors also would like to acknowledge the immensely valuable advice provided to us by multiple experts in clinical practice guideline development and methods of implementation.
Author Disclosure Statement
For A.M.S., no competing financial interests exist. S.E.C. serves on the ATA Board of Directors. B.R.H. has received honoraria from Eisai Co., Ltd. and Sanofi Genzyme and serves as a consultant for Eisai. J.V.H. serves on the Editorial Board of Thyroid. He is a consultant for Best Doctors and advises regarding clinical research protocol development for Abbvie Pharma and Allergan Pharma. E.N.P. serves as the president-elect of the ATA. She is also a management council member of the Iodine Global Network. She serves as an associate editor of Thyroid and Clinical Thyroidology. She serves as an editorial board member of Endocrine Practice, Thyroid Research, the European Journal of Clinical Nutrition, Lancet, Diabetes and Endocrinology, the Journal of Clinical and Translational Endocrinology, and Clinical Endocrinology. J.A.S. serves as the ATA treasurer. She is a member of the Data Monitoring Committee of the Medullary Thyroid Cancer Consortium Registry supported by Novo Nordisk, GlaxoSmithKline, Astra Zeneca, and Eli Lilly. P.A.K. is the editor-in-chief of Thyroid; he has been blinded to the review process of this manuscript. R.P.T. serves on the editorial board of Thyroid and on the ATA Board of Directors. He has served as a consultant for Medtronic and Hemostatix. J.J. serves on the editorial boards of Thyroid, the Journal of Clinical Endocrinology and Metabolism, and Frontiers in Thyroid Endocrinology. She served on the ATA Board of Directors in 2017.