CPGs Were Developed Under New Process Featuring Greater Methodological Rigor
By Maureen Corrigan, Director of Clinical Practice Guidelines, Professional & Clinical Affairs
I’m pleased to announce the Society this month published two new Clinical Practice Guidelines that were developed under a new policy designed to enhance rigor in the CPG methodology and provide greater trustworthiness in the CPG recommendations.
The CPGs, Management of Individuals at High Risk for Hypoglycemia and Treatment of Hypercalcemia of Malignancy in Adults, are the last in a series of three guidelines released in 2022 that better adhere to the Institute of Medicine/National Academy of Medicine Standards for Trustworthy Guidelines.
Improvements in our CPG development process include, but are not limited to:
The other CPG that used this methodology, released in June 2022, is Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Settings.
As with all CPGs, the two new guidelines add important recommendations that allow clinicians to provide the best patient care possible. The new CPGs address the following:
The Management of Individuals at High Risk for Hypoglycemia
The guideline updates the Society’s 2009 inpatient hypoglycemia guideline and focuses solely on people with diabetes-related hypoglycemia. Hypoglycemia is associated with various unwanted outcomes, including distress in those with diabetes and their caregivers, reductions in quality of life (QOL), and reductions in medication adherence, leading to increased risks for diabetes-related comorbidities.
This hypoglycemia guideline incorporates recommendations to treat and manage hypoglycemia more effectively using new insulins and forms of glucagon, and advancements in continuous glucose monitoring (CGM) and insulin pump technology.
The Treatment of Hypercalcemia of Malignancy in Adults
The guideline addresses hypercalcemia, or excess calcium in the blood, which can occur in between 2 percent and 30 percent of cancer patients. Hypercalcemia of malignancy (HCM) is most frequently seen in breast, lung, and renal cancer as well as multiple myeloma.
The hypercalcemia guideline includes the recommendation that adults with HCM should receive treatment with denosumab (Dmab) or an intravenous (IV) bisphosphonate (BP). Additionally, adults with calcitriol-mediated HCM should first be treated with glucocorticoids, with the addition of Dmab or an IV BP if glucocorticoid therapy is insufficient.
Releasing a new CPG—let alone two in a short time span—represents a significant milestone in our field. But we don’t rest on our laurels. Already we are working on new or updated guidelines.
One guideline currently in development is an update to our vitamin D guideline (2011), which is expected to publish in late 2023 or early 2024. Additional guidelines in development or planned for development include:
Development of these and other guidelines is a complex process that spans several years. We dedicate significant time and resources to this endeavor because we know CPGs are highly valued, not only by endocrinologists but the entire medical community.
Our guidelines are used to improve patient care and health outcomes. They also inform research agendas, public policy, and insurance coverage for endocrine conditions.
How are they created? The process begins when our Clinical Guidelines Committee (CGC) and Board of Directors select a series of guideline topics. This is done using predefined, decision-making criteria that includes a thorough search of external clinical guidance documents on the topic, an annual review of existing Society CPGs, and a variety of scientific and clinical benchmarks to ensure we’re providing the most up-to-date recommendations.
We also periodically solicit guideline topics from members.
New topics and guideline updates are selected on an annual basis, and six topics are generally in development at any given time.
Once topics are decided, the task of developing an actual CPG goes to our Guideline Development Panel (GDP) members, a group of experts identified by the CGC, the Board, as well as any co-sponsoring organizations.
The composition of the GDP is very important. We seek to have multidisciplinary panels with representation from the appropriate specialties relevant to the topic. Every GDP also includes a patient representative to make sure patient values and preferences are included in guideline development at all stages.
All GDP members undergo a conflict-of-interest review and must adhere to our strict COI policy.
Also working on the panel is an Endocrine Society Guideline Methodologist (ESGM), along with an additional methodologist from the Mayo Evidence-based Practice Center. These individuals work to complete the systematic reviews and lead the panel in application of the methodology.
CPGs are developed following the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. This methodology includes the use of Evidence-to-Decision (EtD) Frameworks to ensure all important criteria are considered when making recommendations.
The GRADE process begins with a scoping process and prioritization of clinical questions and outcomes to be addressed in the guideline. The Mayo Evidence-based Practice Center external research team conducts a systematic review for each of the questions and produces evidence summaries and GRADE evidence profiles that summarize the body of evidence for each question and the certainty of the evidence. Certainty of evidence is graded as high, moderate, or low based on various criteria.
In parallel to development of the evidence summaries, which analyze the benefits and harms of the intervention, the GDP members research EtD criteria that are not included in the systematic reviews.
The EtD framework provides a systematic and transparent approach for going from the evidence to the healthcare decision. EtD criteria include:
During a series of video conferences or at an in-person meeting, the GDP judges the balance of benefits and harms identified through the evidence review, along with other EtD criteria, to determine the direction and strength of the recommendation. Recommendations can be strong or conditional either for or against the intervention. Learn more about our guideline development process.
Once consensus is reached—and all i’s are dotted, and t’s crossed—we publish our CPGs in The Journal of Clinical Endocrinology & Metabolism (JCEM) and publicize them in the medical and lay press, as well as among our membership.
It’s a long process, but one that underpins our field. CPGs help ensure clinicians from around the world provide the best care possible for their patients, a goal that lies at the heart of the Society’s work.