Expanded

Handbook Process and Methodology

This handbook, one of the World Health Organization’s Family Planning Cornerstones, provides evidence-based guidance developed through worldwide collaboration. Its contents are based on the best scientific evidence available. Family planning experts from around the world have reviewed this evidence and considered what it means for the safe and effective provision of contraceptive methods. The guidance in this handbook reflects their consensus. It also reflects their knowledge and experience with reproductive health care around the world.

The World Health Organization (WHO), Department of Reproductive Health and Research, invited and convened the organizations and experts who participated in developing this handbook. More than 30 technical assistance and service delivery organizations, many of them members of the Implementing Best Practices Consortium, have participated. The INFO Project at the Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs led the editorial process that brought together technical writers and technical experts to develop the text of the book.

This handbook is the successor to The Essentials of Contraceptive Technology, first published in 1997 by the Population Information Program (now the INFO Project) at Johns Hopkins University. Its text served as the starting point for much of the text in this handbook. All the content in this book, however, has been thoroughly reviewed, and the available new evidence has been examined. As a result, the format of the 2 books is similar, but much of the text has been considerably revised and updated for this new handbook.

Processes

Several consensus development processes contributed to the guidance in this handbook:

• WHO Family Planning Cornerstones. The guidance of 2 other WHO Family Planning Cornerstones, the Medical Eligibility Criteria for Contraceptive Use and the Selected Practice Recommendations for Contraceptive Use, are incorporated into this book. Both of these guidelines reflect the work of expert Working Groups convened by WHO to address important issues concerning contraceptive use. The expert Working Groups developed consensus recommendations on the basis of systematic reviews of research findings. The Medical Eligibility Criteria address who can use contraceptive methods safely. The full Medical Eligibility Criteria appear in Appendix D. The Selected Practice Recommendations address how to use contraceptive methods safely and effectively. The questions addressed by the Selected Practice Recommendations are listed.
  
• Working Group Meeting. To supplement guidance based on the Medical Eligibility Criteria and the Selected Practice Recommendations, WHO convened a Working Group meeting to address selected additional questions of importance. This meeting took place at WHO headquarters in Geneva, Switzerland, on 21-24 June 2005. The meeting followed a process like those used in the meetings that developed the Medical Eligibility Criteria and the Selected Practice Recommendations. The research writers of the INFO Project prepared the literature reviews for this meeting. These were not formal systematic reviews but instead were comprehensive reviews that considered all available evidence and, as presented to the Working Group, emphasized the most reliable sources. Names of Working Group members can be found below. The questions addressed at this meeting are also listed below. The Working Group's guidance on these issues is reflected in the handbook text where these topics are covered.
  
• Subgroups. Several subgroups of the expert Working Group met in advance of the June 2005 meeting to consider topics needing special attention. Considering evidence assembled from literature reviews by INFO research writers, these groups made recommendations concerning content and presentation of the topic areas. The topics of the subgroups’ work are listed below.

At the June 2005 meeting the larger expert Working Group reviewed and endorsed the recommendations of these subgroups. Members of some of these subgroups continued after the June meeting to work together, refining the presentation of guidance on some of these topics. The resulting guidance can be found in various places in the handbook where these topics are addressed.

Content not addressed in one of the consensus processes described above was developed by technical writers at the INFO Project and multiple technical experts working in collaboration. This content is consistent with existing WHO guidance. Expert review was ongoing until text was final. Then a group of experts and, finally, representatives of the supporting organizations had the opportunity to review the entire text.

Notes on Sources, Selection Criteria, and Terminology

The following table provides notes for each section of a typical chapter on a contraceptive method. The sections are presented in the order in which they usually appear in a chapter. Note: Where content was largely developed or agreed upon by one of the consensus methods described above, the name of the chapter section appears in green.

Questions Addressed by Selected Practice
Recommendations

Initiation/Continuation

1. When can a woman start combined oral contraceptives?
2. When can a woman start combined injectable contraceptives?
3. When can a woman have repeat combined injectable contraceptive injections?
4. When can a woman start progestogen-only pills?
5. When can a woman start progestogen-only injectables—depot medroxyprogesterone acetate or norethisterone enantate?
6. When can a woman have repeat progestogen-only injectables—depot medroxyprogesterone acetate or norethisterone enantate?
7. When can a woman start using an implant?
8. How long can levonorgestrel implants be left in place?
9. When can a woman have a copper-bearing IUD inserted?
10. Should prophylactic antibiotics be provided for copper-bearing IUD insertion?
11. When can a woman have a levonorgestrel-releasing IUD inserted?
12. Should prophylactic antibiotics be provided for levonorgestrel-releasing IUD insertion?
13. How can a woman take emergency contraceptive pills?
14. Can a woman receive an advance supply of emergency contraceptive pills?
15. When can a man rely on his vasectomy for contraception?
16. What can a Standard Days Method user do if she has menstrual cycles outside the 26–32 day range?

Incorrect Use

17. What can a woman do if she misses combined oral contraceptives?
18. What can a woman do if she misses progestogen-only pills?

Problems During Use

19. What can a woman do if she vomits and/or has severe diarrhoea while using combined oral contraceptives or progestogen-only pills?
20. What can a woman do to prevent nausea and vomiting when taking emergency contraceptive pills?
21. What can a woman do if she vomits after taking emergency contraceptive pills?
22. What can be done if a woman has menstrual abnormalities when using a progestogen-only injectable—depot medroxyprogesterone acetate or norethisterone enantate?
23. What can be done if a woman experiences menstrual abnormalities when using implants?
24. What can be done if a woman experiences menstrual abnormalities when using a copper-bearing IUD?
25. What can be done if a woman experiences menstrual abnormalities when using a levonorgestrel-releasing IUD?
26. What should be done if a woman using a copper-bearing IUD is diagnosed with pelvic inflammatory disease?
27. What should be done if a woman using a levonorgestrel-releasing IUD is diagnosed with pelvic inflammatory disease?
28. What should be done if a woman using a copper-bearing IUD is found to be pregnant?
29. What should be done if a woman using a levonorgestrel-releasing IUD is found to be pregnant?

Programmatic Issues

30. What examinations or tests should be done routinely before providing a method of contraception?
31. How many pill packs (combined or progestogen-only pills) should be given at initial and return visits?
32. What follow-up is appropriate for combined oral contraceptive,
    progestogen-only pill, implant and IUD users?
33. How can a provider be reasonably sure that a woman is not pregnant?

Questions Addressed by the June 2005 Expert Working Group

1. What are updated evidence-based side effects, risks and benefits for each method?
2. What is the definitive list of reasons to see a doctor or nurse while using each method?
3. Does the continuous use of combined oral contraceptives affect their safety or effectiveness?
4. Does shortening the hormone-free interval between cycles of COCs affect their safety or effectiveness?
5. Can providers with brief specific training safely and effectively provide combined and progestin-only pills? Injectables? IUDs?
6. STI risk assessment: What guidance can providers be given about how to assess “high individual risk” of STIs among potential IUD users? (also addressed by a subgroup)
7. What are appropriate back-up methods? Specifically, when is a spermicide an appropriate back-up method of contraception? Emergency Contraceptive Pills?
8. What is the appropriate guidance when the pregnancy checklist does not apply and pregnancy tests are not available? (also considered by a subgroup)
9. What is the preferred order of speculum insertion and bimanual examination during IUD insertion?
10. What can be done if a woman experiences menstrual abnormalities when using COCs? Progestin-only pills?
11. What can be done if a woman experiences nonmenstrual side effects when using hormonal contraceptives—nausea, dizziness, breast tenderness, mood changes, weight change, loss of sex drive?
12. What are the essential condom use instructions? (also addressed by a subgroup)

Topics Addressed By Subgroups

• Side effects, health benefits, and health risks of contraceptive methods
• Reasons to return to the clinic
• When is a follow-up visit required?
• Whether and what role specific contraceptive methods might play in cervical and breast cancer, sexually transmitted infection and pelvic inflammatory disease, migraines, and loss of bone density
• Effectiveness of contraceptive methods
• How to be reasonably certain that a woman is not pregnant in situations not already covered by the pregnancy checklist (also addressed by the Working Group)
• How to assess whether IUD candidates face very high individual risk of gonorrhea or chlamydia (also addressed by the Working Group)
• Essential condom use instructions (also addressed by the Working Group)
• How to present complex information about cancer risks, birth defects, ectopic pregnancy, and pelvic inflammatory disease
• Switching from an IUD to female sterilization

References

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