Methods of U.S. MEC, 2024 (2024)

Methods

Since publication of the 2016 U.S. MEC, CDC has monitored the literature for new evidence relevant to the recommendations through the WHO/CDC Continuous Identification of Research Evidence (CIRE) system.^[16] This system identifies new evidence as it is published and allows WHO and CDC to update systematic reviews and facilitate updates to recommendations as new evidence warrants. Automated searches are run in PubMed weekly, and the results are reviewed. Abstracts that meet specific criteria are added to the web-based CIRE system, which facilitates coordination and peer review of systematic reviews for both WHO and CDC. For this update, CDC reviewed all existing recommendations in the 2016 U.S. MEC for new evidence identified by CIRE that had the potential to lead to a changed recommendation. To obtain comments from the public about revisions to CDC's contraception recommendations (U.S. MEC and U.S. Selected Practice Recommendations for Contraceptive Use [U.S. SPR]), CDC published a notice in the Federal Register (86 FR 46703) on August 19, 2021, requesting public comment on content to consider for revision or addition to the recommendations and how to improve the implementation of the guidance documents.^[17] The comment period closed on October 18, 2021. CDC received 46 submissions from the general public, including private persons, professional organizations, academic institutions, and industry. CDC reviewed each of the submissions and carefully considered them when revising the recommendations.

During January 21, 25, and 26, 2022, CDC held virtual scoping meetings that included 27 participants with expertise in contraception, adolescent health, and thrombosis, as well as representatives from partner organizations, to solicit their individual input on the scope for updating both the 2016 U.S. MEC and 2016 U.S. SPR. The 27 invited participants represented various types of health care providers and health care provider organizations. Lists of participants and potential conflicts of interests are provided at the end of this report. Meeting participants discussed topics to be addressed in the update of U.S. MEC on the basis of the presentation of new evidence published since 2016 (identified through the CIRE system), submissions received through the Federal Register notice, and feedback CDC received from other sources (e.g., health care providers and others through e-mail, public inquiry, and questions received at conferences). CDC identified multiple topics to consider when updating the guidance, including revision of existing recommendations for certain characteristics or medical conditions (postpartum, postabortion, obesity, anticoagulant therapy, known thrombogenic mutations, viral hepatitis, cirrhosis, liver tumors, sickle cell disease, and solid organ transplantation), addition of recommendations for new characteristics or medical conditions (chronic kidney disease and antiphospholipid syndrome), and addition of recommendations for new contraceptive methods (including new formulations of combined oral contraceptives [COCs], contraceptive patches, vaginal rings, progestin-only pills [POPs], levonorgestrel intrauterine devices [LNG-IUDs], and vaginal pH modulator). CDC determined that all other recommendations in the 2016 U.S. MEC were up to date and consistent with the existing body of evidence for that recommendation.

In preparation for a subsequent expert meeting held during January 25–27, 2023, to review the scientific evidence for potential recommendations, CDC staff members and other invited authors conducted systematic reviews for each of the topics being considered. The purpose of these systematic reviews was to identify direct and indirect evidence about the safety of contraceptive method use by persons with selected characteristics or medical conditions (e.g., risk for disease progression or other adverse health effects in persons with chronic kidney disease who use combined hormonal contraceptives [CHCs]). Person-centered outcomes that might represent contraceptive users' values and preferences (e.g., method continuation and patient satisfaction) were considered where relevant and available for each of the systematic reviews. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed for reporting systematic reviews.^[18] The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of the evidence.^[19],[20] Certainty of evidence was rated as high, moderate, low, or very low depending on criteria including study design, risk for bias, indirectness, imprecision, and inconsistency. Outcomes evaluated in randomized clinical trials (RCTs) are considered to have high certainty of evidence and those in observational studies to have low certainty; these ratings are adjusted according to the previously mentioned criteria. When direct evidence was limited or not available, indirect evidence (e.g., evidence on proxy outcomes or among healthy persons) and theoretical issues were considered. Reviews are referenced and cited throughout this report; the full reviews will be submitted to peer-reviewed journals and will contain the details of each review, including the systematic review question, literature search protocol (registered in https://www.crd.york.ac.uk/PROSPERO), inclusion and exclusion criteria, evidence tables, and quality assessments. Brief summaries of the evidence and GRADE tables are included (Supplementary Appendix, https://stacks.cdc.gov/view/cdc/156516). CDC staff members continued to monitor new evidence identified through the CIRE system during the preparation for the January 2023 meeting.

In addition to the preparation of the systematic reviews, CDC included patient perspectives in the guideline update process to better consider how the resulting updated recommendations could meet patient preferences and needs. Consideration of patient perspectives can center discussions on the evidence in a person-centered care model, can support inclusion of patient perspectives along with provider perspectives on the evidence, and has the potential to shape recommendations.^{[14],[21],[22]} In November and December 2022, listening sessions were held with a different group of 18 participants, representing themselves or patient advocacy organizations, who provided perspectives from patient populations such as youths; lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+) persons; persons with disabilities; and persons with chronic medical conditions. The goal of the listening sessions was to gather insights about participants' experiences, values, preferences, and information needs related to contraceptive choice and decision-making.

During January 25–27, 2023, in Atlanta, Georgia, CDC held a meeting with 40 participants who were invited to provide their individual perspectives on the scientific evidence presented and the implications for practice for U.S. MEC. Thirty-eight participants represented a wide range of expertise in contraception provision, research, and reproductive justice and included obstetricians and gynecologists, pediatricians, family physicians, internal medicine physicians, nurse practitioners, epidemiologists, and others with research and clinical practice expertise in contraceptive safety, effectiveness, and management. Two participants were patient representatives who provided their individual perspectives on the topics discussed throughout the meeting. Six additional participants with expertise relevant to specific topics on the meeting agenda provided information and participated in the discussion on their topic of expertise only (e.g., an expert in kidney disease was asked to provide general information about the condition and to assist in interpreting the evidence and any theoretical concerns on the use of contraceptive methods in persons with the condition). During the meeting, a summary of the information from the patient listening sessions was presented, and the two patient representatives presented information on their individual experiences and perspectives related to receipt of contraceptive services. The evidence from the systematic review for each topic was presented, including direct evidence and any indirect evidence or theoretical concerns. Meeting participants provided their individual perspectives on topics discussed throughout the meeting and on using the evidence to develop recommendations that would meet the needs of U.S. health care providers and the patients they serve. Participants also provided feedback on the certainty of evidence, the balance of benefits and harms, and values and preferences. Areas of research that need additional investigation also were considered during the meeting. Lists of participants and potential conflicts of interest are provided at the end of this report.

After the January 2023 meeting, CDC determined the recommendations in this report, taking into consideration the individual perspectives provided by the meeting participants. Feedback also was received from a group of four external reviewers, composed of health care providers and researchers who had not participated in the scoping or update meetings. These external reviewers were asked to provide comments on the accuracy, feasibility, and clarity of the recommendations.

References