1. Purpose and Process of WHO guideline development
World Health Organization
Increasing Access to Next Generation Injectables
Working Meeting
Dakar, Senegal
23 May 2018
Purpose and Process of WHO guideline development
James Kiarie
Coordinator
Department of Reproductive Health & Research, WHO
1)We rate quality of a body of evidence in terms of 4 categories: very low, low, moderate, or high quality?
this looks at levels and methodological quality of evidence
likelihood of bias
by outcome
2) Recommendation: 2 grades - weak or strong (for or against)?
Confidence in recommendations decreases if studies have major limitations that may bias the estimates, but
Quality of evidence only one factor in deciding whether recommendation is weak or strong 1 1 1

2. WHO Guidelines, Derivative Documents & tools Family Planning
Medical Eligibility Criteria
Selected Practice Recommendations
The Medical Eligibility Criteria (MEC) Wheel (new)
Guide to family planning for community health care providers and their clients
(to be updated)
5th edition 2015
3rd edition in 2016
Ensuring Human Rights with Contraceptive Service Delivery
(An Implementation Guide)
Decision-Making Tool
(to be updated)
Global Handbook
To be updated in 2017

3. The Medical Eligibility Criteria for Contraceptive Use
WHO’s Evidence-based guidance to develop and implement family planning guidelines for national programmes.
Provides thorough information and guidance on the safety of various contraceptive methods for use in the context of specific health conditions and characteristics.
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4. 2017 guidance: expected soon, stay tuned!
WHO MEC guidance on use of hormonal contraception for women at high risk of HIV
2014 guidance: no restriction on any HC method, with a clarification for progestin-only injectables:
“Women at high risk of HIV infection should be informed that progestogen-only injectables may or may not increase their risk of HIV acquisition. Women and couples at high risk of HIV acquisition considering progestogen-only injectables should also be informed about and have access to HIV preventive measures, including male and female condoms.”
2017 guidance: expected soon, stay tuned!

5. MEC REVIEW GSG GDG WHO CIRE Guideline Steering Group
Continuous Identification and Review of Evidence
Review and synthesis of published literature may recommend systematic review or refer to GSG
GSG
Guideline Steering Group
Assessment of the evidence and decision No review, immediate review or at next review of MEC
GDG
Guideline Development Group
Review evidence and recommendations based on GRADE (Grades of Recommendation Assessment, Development and Evaluation)
WHO
Approves and Issues Guideline
Approval by the Guideline Steering Committee (GRC) and the ADGO

6. Quality of the Evidence
The extent to which one can be confident that an estimate of effect or association is correct.
High, further research is very unlikely to change our confidence in the estimate of effect
Moderate, further research is likely to have an important impact on our confidence in the estimate and may change the estimate
Low, further research is very likely to have an important impact on our confidence in the estimate and is likely to change the estimate
Very low, any estimate of effect is very uncertain

7. MEC Recommendations quality of available evidence
desirable and undesirable effects
values and preferences
Category 1: no restriction on use
Category 2: advantages generally outweigh theoretical or proven risks
Category 3: theoretical or proven risks usually outweigh advantages
Category 4: unacceptable health risk

8. WHAT NEXT Communication of WHO statement on HC and HIV
Introduction of guidance into National guidelines and practice
The ECHO trial
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9. Communication of WHO statement on HC and HIV
Publication in early March on WHO website:
Full statement pages
Web story
FAQ
Press release
Pre release webinars with stakeholders, Ministries of Health and UN organizations that will be expected to respond to the issue
Key objective is to get out the an accurate message
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10. Introduction of guidance into National guidelines and practice
Will be supported by WHO AFRO and WHO HQ
Planning meetings of WHO Country offices and ministries of health from April 2017
Key objective is for program managers, providers and clients to receive correct evidence based message
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11. Update on the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial
A Multi-Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in 7800 Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUD)
A randomized trial, if done well, wil:
Provide clear guidance for policymakers and programs;
Help to formulate clear counselling messages for clinicians; and
Permitting women to make fully informed choices.

12. ECHO Team
Currently funded by the Bill & Melinda Gates Foundation, the Swedish International Development Cooperation Agency, the Medical Research Council of South Africa, and the United Nations Population Fund,
Contraceptive supplies supported by the Government of South Africa and the United States Agency for International Development.

14. Thank you
For more information, Follow us Website who.int/reproductivehealth