U.S. Medical Eligibility Criteria for Contraceptive Use, 2016

Required Elements for Initial Public Posting

Title: U.S. Medical Eligibility Criteria for Contraceptive Use, 2016

Subject of Planned Report: The evidence-based recommendations in this document provide guidance to health care providers on the safe use of contraceptive methods for women and men with certain medical conditions or characteristics.  This guidance document is an update to the previously published U.S. Medical Eligibility Criteria for Contraceptive Use, 2010.

Purpose of Planned Report: The recommendations in this document are intended to assist health care providers when they counsel women, men, and couples about contraceptive method choice.

Type of Dissemination:  Influential Scientific Information (ISI) Publication in MMWR

Timing of Review (including deferrals):  January 6-22, 2016

Type of Review (panel, individual or alternative procedure): Individual

Opportunities for the Public to Comment (how and when): None

Peer Reviewers Provided with Public Comments before the Review: No

Anticipated Number of Reviewers: 3

Primary Disciplines or Expertise: Obstetrics/gynecology, family planning, pediatrics, women’s health

Reviewers Selected by (agency or designated outside organization):  Agency

Public Nominations Requested for Reviewers: No

Additional elements to be added to the public posting as they become available

For Each Peer Reviewer Selected:

Name: Mimi Zieman
Degree/Qualifications: MD
Position/Title: Chief Medical Officer, Planned Parenthood Southeast; Section Editor for Family Planning, UpToDate
Employer: Planned Parenthood Southeast
Primary Discipline or Expertise: Contraception and Family Planning

Name: Abigail R.A. Aiken
Degree/Qualifications: MD, MPH, PhD
Position/Title: Postdoctoral Research Associate
Employer: Princeton University
Primary Discipline or Expertise: Sexual and Reproductive Health, Population Science

Name: Linda Burdette
Degree/Qualifications: PA-C, MPAS, DFAAPA
Position/Title: Clinician at Premier Women’s Health of Yakima
Employer: Jonathan Johns, MD
Primary Discipline or Expertise: Women’s health/gynecology

Charge to Peer Reviewers:

The U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 (U.S. MEC) is an update of the 2010 U.S. MEC. These recommendations were finalized after consultation with a group of health professionals who met in Atlanta, Georgia, during August 2015. This guidance comprises recommendations that address the safe use of contraception in women and men with certain characteristics and medical conditions.  The recommendations in this document are intended to assist health care providers when they counsel women, men, and couples about contraceptive method use and to serve as a source of clinical guidance.  Thus, the target audience for this document is health care providers who provide family planning services.

This review should address the following issues:

1. Accuracy: While we do not expect you to do any independent literature reviews, do the recommendations seem consistent with the data as you are familiar with it? Are there omissions of information or key studies that should be included?
2. Feasibility:  Are these recommendations feasible for use by clinicians providing family planning services?
3. Clarity:  Are the recommendations clear and understandable for use by providers?
4. Additional comments:  We would be happy to receive any additional comments that you may have.

Peer reviewer comments:

Peer reviewer comments were focused on increasing the clarity of the recommendation language, as well as providing suggestions about items to address in the next edition of the guidance.  Several comments were made on recommendations that were not open for reconsideration in this update; we will keep those comments and consider them for the next update.  Reviewers’ comments are summarized below.

Comprehensive comments:

• Box 2 (listing of conditions associated with increased risk as a result of pregnancy) should be part of the actual MEC tables.
• Abbreviations for some of the contraceptive methods are confusing.

Comments for clarity:

• Numerous comments were made to increase the clarity of the wording of the recommendations.

Considerations for the next update and research gaps:

• Add recommendations for the contraceptive sponge.

CDC’s response to peer review comments:

The peer reviewer comments have been addressed and incorporated into the document.  Substantive changes include the following:

Comprehensive comments:

• Added information about Box 2 (listing of conditions associated with increased risk as a result of pregnancy) throughout the actual MEC tables.
• Added information from the text about long-acting, highly effective contraceptive methods may be the best choice for women with Box 2 conditions as a footnote.
• Clarified how we refer to the various contraceptive methods and removed some abbreviations.

Comments for clarity:

• All minor editorial comments were incorporated.
• Comments that changed the language of recommendations that were not addressed in this updated were not incorporated, but noted for the next revision.
• Comments that the summary of changes section should include more detail were not made, as this is a summary and readers will need to look at the full recommendation for the details.
• Clarified the background of the external reviewers.
• Clarified that Box 2 conditions are associated with increased risks as a result of any pregnancy, not just unintended pregnancy.
• Clarified text in the migraine recommendations.
• Added further clarification to the recommendations for use of progestin-only methods among women using antiretroviral therapies.
• Added further clarification to the recommendations for use of progestin-only methods among women using St. John’s wort.
• Defined “interval placement” of IUDs.
• Clarified the evidence summary for combined hormonal contraceptives and migraines.
• Clarified language about providers in the Fertility Awareness-base Methods chapter.

Considerations for the next update and research gaps:

• We will consider all of the suggestions for the next update.  We will also add the research gaps to our publication on research gaps identified through the update process.