U.S. Selected Practice Recommendations for Contraceptive Use, 2016

Required Elements for Initial Public Posting

Title: U.S. Selected Practice Recommendations for Contraceptive Use, 2016

Subject of Planned Report: Evidence-based recommendations are provided on the safe and effective use of contraceptive methods and address provision of contraception and management of side effects and other problems with contraceptive method use.  This guidance document is an update to the previously published U.S. Selected Practice Recommendations for Contraceptive Use, 2013.

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 use and to serve as a source of clinical guidance.

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: 4

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

Reviewers Selected by (agency or designated outside organization):  Centers for Disease Control and Prevention (CDC)

Public Nominations Requested for Reviewers: No

For each Peer Reviewer Selected:

Name: Carrie Cwiak
Degree/Qualifications: MD, MPH
Position/Title: Associate Professor of Gynecology and Obstetrics and Epidemiology, Family Planning Division Director (in the Department of Gynecology and Obstetrics)
Employer: Emory University School of Medicine
Primary Discipline or Expertise: OB/GYN, Family Planning, Epidemiology

Name: Seema Menon
Degree/Qualifications: MD
Position/Title: Associate Professor of Obstetrics and Gynecology, Program Director Pediatric and Adolescent Gynecology
Employer: Medical College of Wisconsin
Primary Discipline or Expertise: Obstetrics and Gynecology, Pediatric and Adolescent Gynecology

Name: David A. Klein
Degree/Qualifications: MD, MPH
Position/Title: Chief, Adolescent Medicine at Fort Belvoir Community Hospital and Assistant Professor of Family Medicine and Pediatrics at the Uniformed Services University, Bethesda, MD
Employer: United States Air Force
Primary Discipline or Expertise: Family Medicine Residency, Adolescent Medicine Fellowship

Name: Claude A. Burnett
Degree/Qualifications: M.D., M.P.H.
Position/Title: District Health Director, Northeast Health District
Employer:  Georgia Department of Public Health
Primary Discipline or Expertise:  Public Health/Family Planning

Charge to Peer Reviewers:

The U.S. Selected Practice Recommendations for Contraceptive Use, 2016 (U.S. SPR) is an update of the 2013 U.S. SPR.  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 a select group of common, yet sometimes controversial or complex, management issues around the initiation and use of specific contraceptive methods.  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:

Consider the use of gender neutral language throughout the document wherever possible, if it does not affect the meaning, e.g., “persons” or “clients” rather than “women”.

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:

• Techniques to get through the bleeding problems inherent in implant use would be helpful.
• Advice about the safety and acceptability of dual method use for short transition periods would also be desirable.
• Guidance on overlapping use of injectables, implants, and IUDs whenever a woman decides to switch would be desirable.
• More data are needed on medications to ease IUD insertion.
• Consider making recommendations on number of days of back-up needed for various contraceptive methods more conservative but consistent across methods to facilitate communication.
• Consider changing the format or assessing whether providers prefer a method-based or question-based format. It may be possible for future editions to shorten the document substantially by changing the format and so cutting the redundancy.

Comments about dissemination and implementation of the guidance:

• Useful communication tools that help patients understand their risk of unintended pregnancy with various contraceptive methods and based on discontinuation rate of various contraceptive methods are needed.

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:

We appreciate and carefully considered the comment to change “woman” to “persons” or “clients” throughout the document.  We did not make that change at this time, but will continue to consider how we can address this issue in the future.

Comments for clarity:

• All minor editorial comments were incorporated.
• Comments that changed the language of recommendations that were not addressed in update 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.
• Added back in language about WHO’s intent that global guidance should be adapted at the local level.
• Variations in the language for the update recommendation on ulipristal acetate were reconciled.
• Clarified the use of ulipristal acetate when switching to a Cu-IUD.
• Considered whether we could be more definitive in the evidence summary about medications that have been assessed to ease IUD insertion, but the available evidence does not allow for this.
• Moved the summary of changes table to earlier in the text.
• Moved the definitions of the MEC classifications to earlier in the text.
• Moved the section on maintaining the guidance to earlier in the text.
• Additional references suggested were incorporated.
• Clarified that screening exams not necessary for contraceptive use, but needed for preventive health care, can be conducted at the same time as initiation of the contraceptive methods.
• Clarified when back-up methods are not needed for postpartum women.

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.

Comments about dissemination and implementation of the guidance:

We will consider all of these suggestions as we develop our dissemination and implementation plan for these guidelines.