Annual technical report: 2014 : department of reproductive health and research, including UNDP/UNFPA/WHO/World Bank Special Programme of Research Training in Human Reproduction (‎HRP)‎

Publication date: 2015

Annual technical report 2014 Department of Reproductive Health and Research including UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research, including the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Annual Technical Report, 2014 WHO/RHR/15.10 © World Health Organization 2015 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-com- mercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/ licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distin- guished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed by the WHO Document Production Services, Geneva, Switzerland Table of contents Acronyms and abbreviations vii 1. Introduction 1 2. High-level advocacy and input to global initiatives for sexual and reproductive health 3 3. Thematic areas 11 3.1 Family planning and contraception 11 3.2 Adolescent sexual and reproductive health 29 3.3 Maternal and perinatal health 40 3.4 Preventing unsafe abortion 69 3.5 Sexually transmitted infections (STIs) and reproductive tract infections (RTIs), including multipurpose prevention technologies (MPTs) and SRH–HIV linkages 75 3.6 Cervical cancer 92 3.7 Violence against women and harmful practices, including female genital mutilation and early marriage 99 3.8 Sexual and reproductive health in humanitarian settings 110 3.9 Infertility 113 3.10 Sexual Health 123 4. Cross-cutting topics 127 4.1 Human rights and gender equality 127 4.2 Innovations 134 4.3 Biostatistics and data management 139 4.4 Advocacy and communications 142 4.5 Research project review 153 5. Research capacity strengthening, including the HRP Alliance 157 Annex A. HRP results report 2014–2015 (provisional expenditure data) 167 Annex B. Indicator report 182 Annex C. Donors 2013-2014. 202 Acronyms and abbreviations vii ACS antenatal corticosteroids AHI adolescent health intervention AMR antimicrobial resistance ANC antenatal care ARV antiretroviral ASRH adolescent sexual and reproductive health ASRM American Society for Reproductive Medicine AYSRH adolescent and youth sexual and reproductive health BASTA Battling Against Syphilis – a Team Approach (listserve) BOLD Better Outcomes in Labour Difficulty (project) BV bacterial vaginosis C4-GEP Comprehensive cervical cancer control: a guide to essential practice CAF Country Accountability Framework CAPRISA Centre for AIDS Prevention and Research in Southern Africa CCM Country Coordination Mechanism CDC United States Centers for Disease Control and Prevention CEFM child, early and forced marriage CERQual Confidence in the Evidence from Reviews of Qualitative research tool CESCR Committee on Economic, Social and Cultural Rights CHAI Clinton Health Access Initiative CIRE Continuous Identification of Research Evidence CoIA Commission on Information and Accountability for Women’s and Children’s Health CONSORT Consolidated Standards of Reporting Trials CoP Communities of Practice COS controlled ovarian stimulation CRPD Committee on the Rights of Persons with Disabilities CRVS civil registration and vital statistics CSE comprehensive sexuality education DECIDE Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence framework DHS Demographic and Health Survey DMPA depot medroxyprogesterone acetate DP Depo-Provera DSMB Data Safety and Monitoring Board EC emergency contraception ECOWAS Economic Community of West African States ECSA-HC East, Central and Southern African Health Community Acronyms and abbreviations Annual Technical Report 2014viii EDC Education Development Center EMTCT elimination of mother-to-child transmission EOBC emergency obstetric care EPF European Parliamentary Forum EPMM Ending Preventable Maternal Mortality ERC see WHO-ERC ESSENCE Enhancing Support for Strengthening the Effectiveness of National Capacity Efforts EU European Union EVD Ebola virus disease FANC focused antenatal care FGM female genital mutilation FGM/C female genital mutilation/cutting FIGO International Federation of Gynecology and Obstetrics FIGO-RMC FIGO’s Reproductive Medicine Committee FP2020 Family Planning 2020 (an outcome of the 2012 London Summit on Family Planning) GAC Grants Approval Committee GAP Gender and Rights Advisory Panel GARPR Global AIDS Response Progress Reporting System GASP Gonococcal Antimicrobial Surveillance Programme GAVI GAVI Alliance GDG Guideline Development Group GEAS Global Early Adolescent Study GFF Global Financing Facility GIS geographic information systems GLOSS Global STI Surveillance System GRADE Grading Recommendations, Assessment, Development and Evaluation GREAT Network Guideline-driven, Research priorities, Evidence synthesis, Application of evidence, and Transfer of knowledge GRC Guidelines Review Committee GURM genito/urinary and reproductive medicine H4+ UNFPA, UNICEF, WHO, World Bank, UNAIDS, UN Women HCV hepatitis C virus HPV human papillomavirus HRP UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction; also: Human Reproduction Programme HSV herpes simplex virus IARC International Agency for Research on Cancer IBP Implementing Best Practices ICD International Statistical Classification of Diseases and Related Health Problems ICD-MM WHO Application of ICD-10 to deaths during pregnancy, childbirth and the puerperium (ICD-Maternal Mortality) Acronyms and abbreviations ix ICD-PM WHO Application of ICD-10 to perinatal deaths (ICD-Perinatal Mortality) ICMART International Committee Monitoring Assisted Reproductive Technologies ICPD International Conference on Population and Development ICSI intracytoplasmic sperm injection ICT information and communication technology iEtD interactive Evidence-to-Decision (tool) IFFS International Federation of Fertility Societies IMPRINT Improving the reporting of clinical trials of infertility treatments IMPT Initiative for Multipurpose Prevention Technologies IPPF International Planned Parenthood Federation IPU Inter-Parliamentary Union IRB Institutional Review Board IRP Implementation Research Platform IUD intrauterine device IUI intrauterine insemination IVB Immunization, Vaccines and Biologicals (WHO Department) IVF in vitro fertilization IWG Innovations Working Group KAP knowledge, attitudes and practices LID Long-term Institutional Development (grant) LMIC low- and middle-income countries LNG levonorgestrel LSHTM London School of Hygiene and Tropical Medicine M&E monitoring and evaluation MAPS mHealth for Assessment and Planning for Scale (tool) MCA Maternal, Newborn, Child and Adolescent Health (WHO Department) MCHIP Maternal and Child Health Integrated Program MCS Multicountry Survey MDG Millennium Development Goal MEC Medical eligibility criteria for contraceptive use MHTF Maternal Health Task Force MISP Minimum Initial Service Package MMEIG Maternal Mortality Estimation Interagency Group MMWG Maternal Morbidity Working Group MOH ministry of health MPHO medical products of human origin MPT multipurpose prevention technology MSI Marie Stopes International MSI Management Systems International MSM men who have sex with men mTERG Technical and Evidence Review Group on mHealth for RMNCH Annual Technical Report 2014x NASG non-pneumatic anti-shock garment NCD noncommunicable disease NET-EN norethisterone enanthate NGO nongovernmental organization NIH United States National Institutes of Health NVI Noncommunicable Diseases, Disability, Violence and Injury Prevention (WHO Department) OHCHR Office of the UN High Commissioner for Human Rights OHSS ovarian hyper-stimulation syndrome OpenSRP Open Smart Register Platform PAHO Pan American Health Organization PCC Policy and Coordination Committee PCOS polycystic ovary syndrome PICO population, intervention, comparator and outcome PID pelvic inflammatory disease PMNCH Partnership for Maternal, Newborn and Child Health PMTCT prevention of mother-to-child transmission POCT point-of-care test PPFP postpartum family planning PPH postpartum haemorrhage PREBIC Preterm Birth International Collaborative PRS Programme Reporting Standards PSI Population Services International RCS research capacity strengthening RCT randomized controlled trial RDT rapid diagnostic test RHL Reproductive Health Library RHR Reproductive Health and Research (WHO Department) RMNCAH Reproductive, Maternal, Newborn, Child and Adolescent Health RMNCH reproductive, maternal, newborn and child health RMNH Alliance Alliance for Reproductive, Maternal and Newborn Health RP2 Research Project Review Panel PRRR Pink Ribbon Red Ribbon (global health initiative) RMG Research Mentoring Grant RTI reproductive tract infection RTS room temperature stable SAWG Scientific Advisory Working Group SBA skilled birth attendance/attendant SDG Sustainable Development Goal SELMA Simplified, Effective, Labour Monitoring-to-Action tool Acronyms and abbreviations xi SRH sexual and reproductive health SRHR sexual and reproductive health and rights SPR Selected practice recommendations for contraceptive use STAG Scientific and Technical Advisory Group STI sexually transmitted infection SVRI Sexual Violence Research Initiative TAG Technical Advisory Group TAG Topic Advisory Group TDR Special Programme for Research and Training in Tropical Diseases (hosted at WHO) TMB treaty monitoring body TPP Target Product Profiles TRP Technical Review Panel TRP Training Resource Package for Family Planning TRT Technical Resource Team TT tetanus toxoid TU testosterone undecanoate UHC universal health coverage UICC Union Internationale Contre le Cancer UN United Nations UNAIDS Joint United Nations Programme on HIV and AIDS UNESCO United Nations Educational, Scientific and Cultural Organization UNFPA United Nations Population Fund UNICEF United Nations Children’s Programme UNODC United Nations Office on Drugs and Crime UNPD United Nations Population Division USAID United States Agency for International Development VIA visual inspection of the cervix with acetic acid WAHO West African Health Organisation WHA World Health Assembly WHO World Health Organization WHOCC WHO Collaborating Centre WHO-ERC WHO-Ethics Review Committee Annual Technical Report 2014xii Introduction 1 1. Introduction The UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, also known as the Human Reproduction Programme (HRP), is the main instrument and leading research agency within the United Nations system concerned with sexual and reproductive health and rights. The World Health Organization (WHO) serves as the executing agency for HRP, which is housed within, and forms part of, WHO’s Department of Reproductive Health and Research (RHR Department). Universal access to sexual and reproductive health and rights is recognized worldwide as crucial for accelerating progress towards achieving global goals for sustainable development and poverty reduction – including the Millennium Development Goals (2000–2015), the aims of the Programme of Action of the International Conference on Population and Development (ICPD, 1994), and more recently the commitments of the global Every Woman Every Child movement. The collective blueprint formed by these goals – agreed upon across regions and by the world’s leading institutions concerned with sustainable development – underscores the critical importance of the continuing work undertaken by the RHR Department, including HRP, to promote universal access to sexual and reproductive health. Established in 1972, the Department supports and coordinates research on a global scale; synthesizes research through systematic reviews of literature; builds research capacity in low-income countries; and develops dissemination tools to make efficient use of an ever-increasing body of research and information. By virtue of its unique co-sponsorship arrangement, the work of HRP is coordinated with, and contributes to, the work of its co-sponsors and partners including UNDP, UNFPA, UNICEF, WHO, World Bank, UNAIDS and the International Planned Parenthood Federation (IPPF). The year 2014 represented a critical juncture for the Department and for HRP. Following a successful functional review in 2013, its programme of work was focused on a number of priorities, including family planning, maternal health, and adolescent sexual and reproductive health. The Department’s support for rights- based approaches was strengthened and integrated within all of its work. This report brings together the achievements across all the Department’s thematic areas. It also underlines the urgency of the work that collectively needs to be done to accelerate progress towards realizing sexual and reproductive health and rights. Annual Technical Report 20142 High-level advocacy and input to global initiatives for sexual and reproductive health 3 2. High-level advocacy and input to global initiatives for sexual and reproductive health 2.1 Introduction The RHR Department, including HRP, has engaged in a range of global advocacy activities to promote sexual and reproductive health in the context of regional and global initiatives. These include contributions in follow up to global agreements and commitments relevant to sexual and reproductive health, such as: the International Conference on Population and Development (ICPD), Cairo, 1994, in its 20th anniversary year (ICPD Beyond 2014); the World Conference on Women, Beijing, 1995, in preparation for its 20th anniversary (Beijing+20); and the Millennium Development Goals (MDGs) and preparations for the post-2015 sustainable development agenda. Other contributions include providing support for the accountability work conducted under the umbrella of the United Nations (UN) Secretary-General’s Every Women Every Child initiative; input to the discussions around the development of new accountability frameworks and the renewed Global Strategy for Women’s, Children’s and Adolescents’ Health; work carried out in the context of the UN H4+ initiative; and co-leadership of the performance, monitoring and accountability work of the Family Planning 2020 (FP2020) initiative as well as participation in its governing body. Engagement with political platforms, with a specific focus on Parliaments and Parliamentarians, has also been prominent in our activities, including providing advice to Parliaments and undertaking joint research with the Inter-Parliamentary Union (IPU). Major achievements • The second FP2020 progress report was finalized with the leadership of the FP2020 Performance, Monitoring and Evidence (PME) working group, co-chaired by the Director of the RHR Department. • The WHO Technical Guidance Note: Strengthening the inclusion of reproductive, maternal, newborn and child (RMNCH) health in concept notes to the Global Fund was completed for the Global Fund to Fight AIDS, Tuberculosis and Malaria. • In support of the 20th anniversary of the ICPD Programme of Action (ICPD Beyond 2014), the Department has produced seven fact sheets on key sexual and reproductive health and rights (SRHR) aspects of the ICPD Programme of Action and has disseminated these at many events, including at a high-level meeting co-organized at the time of the UN Commission on Population and Development in New York. • The Pan-African resolution on gender-based violence was developed with technical support from the Department, and was approved by the Pan-African Parliament. • Reports on child, early and forced marriage legislation in Africa and the Asia- Pacific region were developed in collaboration with the Inter-Parliamentary Union and the Pan-African Parliament. • A paper on Women and health: 20 years of the Beijing Declaration and Platform for Action was prepared in collaboration with other WHO departments and has been submitted for discussion at the WHO Executive Board in 2015. Annual Technical Report 20144 2.2 Contribution to global initiatives and follow up of the commitments 2.2.1 The Every Woman Every Child movement and the accountability framework Progress The UN Secretary-General’s Global Strategy for Women’s and Children’s Health and the related Every Woman Every Child movement were launched in September 2010 to accelerate progress towards MDGs 4 (reduce child mortality) and 5 (improve maternal health). The commitments to increase the needed resources and implement effective actions in the context of the Global Strategy have contributed to improving health outcomes for women and children. The approximately 50% reduction in both maternal and infant deaths since 1990 has largely happened during the recent years since the launch of the Global Strategy. A critical part of this Global Strategy was the creation of an accountability mechanism to ensure that commitments to women’s and children’s health were being delivered on time and making an impact. As part of the Global Strategy, the UN Secretary-General called for the establishment of a process to ensure global reporting, oversight and accountability. This led to the creation of the Commission on Information and Accountability for Women’s and Children’s Health (CoIA) in 2011, which put forward 10 recommendations to strengthen accountability. Countries translated these recommendations into Country Accountability Frameworks (CAFs), with prioritized work areas that follow the cycle of “monitoring, review and remedy or action”. In 2014, the Department provided technical support in the development of the third progress report on implementation of the Commission’s recommendations, Accountability for women’s and children’s health: report on progress to May 2014 (1). The 2014 progress report describes the evolution of the accountability work, and marks the end of the first phase of implementation. The report also summarizes progress made globally and by countries towards implementing the Commission’s 10 recommendations. It also presents lessons emerging from midterm reviews in selected countries. In the context of review of the accountability framework established by the UN Secretary-General’s Global Strategy for Women’s and Children’s Health, and the Every Woman Every Child movement, the Department supported the organization of the Stakeholder Consultation, co-convened with the Governments of Canada and Norway, and with the UN Secretary-General’s Office early in November 2014. The Consultation brought together approximately 100 senior representatives from governments, civil society and international organizations to set the foundations for continued improvements in women’s and children’s health post-2015, including the accountability framework and financing. One of the key elements of the Consultation was the discussion around a shared vision for women’s and children’s health beyond 2015, including the key pillars for a renewed Global Strategy for the post-MDG period (2016–2030). It was agreed that the revised Global Strategy should include adolescents and thus the proposal was made for a Global Strategy for Women’s, Children’s and Adolescents’ Health, representing one overarching framework and common vision up to 2030. The second key element was the discussion around the investment and financing for the Global Strategy through the newly created Global Financing Facility (GFF) as well as existing mechanisms such as the GAVI Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund). The aim of the GFF is to leverage additional High-level advocacy and input to global initiatives for sexual and reproductive health 5 funding to fill gaps, create better harmonization of programmes, and ensure country leadership in which financing is aligned with country priorities and plans. Planned activities • In 2015, the Department will support the development of the technical content of the renewed Global Strategy in alignment with the post-2015 sustainable development agenda; the Global Strategy for Women’s, Children’s and Adolescents’ Health is to be launched at the UN General Assembly in September 2015. 2.2.2 ICPD Beyond 2014 and Beijing +20 Progress In 2014, the Department continued its efforts to support the ICPD Beyond 2014 process, including (i) providing support to the UNFPA-led review of progress and gaps in implementation of the ICPD Programme of Action at the 20th anniversary and (ii) providing technical input to countries on key areas of sexual and reproductive health. Seven fact sheets were developed relating to key areas of sexual and reproductive health and rights (SRHR) and these have been disseminated at various forums.1 In this regard, a side event was organized at the time of the UN Commission on Population and Development in New York in September, on SRHR as a key pillar of development. Additionally, the fact sheets were disseminated at a large meeting convened in collaboration with the WHO Regional Office for Africa, with representatives of 29 countries and partner agencies. The Department also developed a position paper based on information available on progress and gaps in implementation of the ICPD Programme of Action: Sexual and reproductive health beyond 2014: equality, quality of care and accountability (2). The position paper highlighted three cross-cutting themes emerging from ongoing evaluation of the ICPD Programme of Action: to address inequalities, to ensure quality of care, and to enhance accountability. The Department has also been involved in the Geneva ICPD Network, providing technical support on several issues related to SRHR, including: violence against women; family planning; child, early and forced marriage; adolescent health; and development of the post-2015 sustainable development agenda. In addition to activities focused on ICPD Beyond 2014, the RHR Department also led WHO’s efforts in examining women’s health issues in the context of the 20th anniversary of the Fourth World Conference on Women, which was held in Beijing in 1995. The Beijing Declaration and Platform for Action set out 12 critical areas of action for the global realization of gender equality and women’s empowerment, one of which was women’s health (3). In view of the upcoming 20th anniversary in 2015, the United Nations Commission on the Status of Women will carry out a review and appraisal of the implementation of the Beijing Declaration and Platform for Action. The Department led WHO’s efforts in preparing a paper examining achievements, unfinished agenda items, and emerging priorities relating to women’s health 20 years after the 1995 Conference and Declaration, with participation of all relevant WHO Departments: Women and health: 20 years of the Beijing Declaration and Platform for Action (4). The paper was discussed at the WHO Executive Board in January 2015, where Member States affirmed commitment to women’s health and provided guidance on WHO’s roles and activities. 1 The factsheets are available at: http: //www.who.int/reproductivehealth/icpd/en/ Annual Technical Report 20146 Planned activities • In early 2015, the comments from the WHO Executive Board about the paper on Women and health will be incorporated to develop a new version that will be discussed at the World Health Assembly in May 2015. The Department will continue to support the follow-up actions on Beijing+20 by providing technical input on health aspects that form part of the discussion. • Additionally, the ICPD fact sheets and related evidence will be disseminated through various channels. The Department will remain actively engaged in the Geneva ICPD Network. 2.3 United Nations H4+ mechanism The UN H4+ mechanism, which combines the efforts of UNFPA, UNICEF, WHO, World Bank, UNAIDS and UN Women, works with countries to support the implementation of commitments to the UN Secretary-General’s Global Strategy and the Every Woman Every Child movement, to accelerate progress towards MDGs 4 and 5. H4+ efforts focus on provision of joint support to countries in planning and implementing effective RMNCH interventions, by strengthening the health systems and improving equity in accessing quality services. Progress The Department led WHO’s efforts in monitoring support of the more than 58 H4+ priority countries through the development and implementation of a results-based global survey of progress in these countries. The Department used the H4+survey results to conduct an analysis of: reported coordination and organization; implementation of the H4+ scope of work; and the contributions of the H4+ in assisting counties to mobilize financial, technical and additional resources. The resulting report, measuring progress in 2013, was presented at a UN General Assembly side session hosted by the H4+ and attended by principles of all six member organizations. The survey found that the H4+ collaboration had led to more effective coordination, collaboration and teamwork among those involved at the country level in advancing RMNCH. Additionally, the mechanism supported country efforts to bring RMNCH issues to the forefront of national attention while also attracting new partners and resources to RMNCH programming. Technical support and expertise was also a reported beneficial effect of H4+ support. The Department was key in providing some of this concentrated technical support to countries, namely through the organization of WHO feedback on 10 country plans for 2015 activities. Planned activities • In 2015, the Department will develop the H4+ 2014 progress report, building upon previous reporting, and will develop qualitative case studies of the H4+ mechanism in action at the country level. The Department will also support implementation of the latest recommendations on effective childbirth care for improved RMNCH in H4+ priority countries, and will support H4+ involvement in planning for the Global Financing Facility in support of Every Woman Every Child. 2.4 Collaboration with the Inter-Parliamentary Union and other parliamentarian networks Together with the Inter-Parliamentary Union (IPU), the Department has established a constructive collaboration with other parliamentarian platforms at the regional level, High-level advocacy and input to global initiatives for sexual and reproductive health 7 such as the European and Pan African Parliaments, which play a crucial role in defining health-related recommendations within the respective regions. Additionally, the Department engages with thematic platforms, such as the Parliamentarian Fora on Population and Development, which has a focus on reproductive health and rights. The goal of the collaboration between the Department and parliamentarians is to better understand the parliamentary processes that can move the global health agenda forward, and to raise the levels of parliamentary investment in health. Additionally, this cooperation serves the purpose of providing technical support to parliamentarians in the development and implementation of health-related multilateral agreements, resolutions, declarations and other legislative tools. The Department has also established collaborations with national parliaments in the area of sexual and reproductive health and rights. Progress The RHR Department has been instrumental in expanding the mandate of the IPU Advisory Group on HIV/AIDS to include RMNCH. The Advisory Group is supported technically by WHO (represented by the Director of the RHR Department), UNAIDS, the Global Fund, and the Partnership for Maternal, Newborn and Child Health (PMNCH). In follow up to the 2012 IPU resolution on Access to health as a basic right: the role of Parliaments in addressing key challenges to securing the health of women and children (5), the IPU General Assembly decided to initiate a process to review the resolution with the support of the RHR Department and other partners; this review will be presented at the next IPU General Assembly in Hanoi, Viet Nam, in 2015. With the support of the Department, the IPU has placed increasing emphasis on reproductive health. Two issues were identified as entry points for this focus: (i) early, child and forced marriage and (ii) access to information and services relating to family planning. More recently the Department supported the IPU in the preparation and negotiation of the resolution Towards risk-resilient development: taking into consideration demographic trends and natural constraints, which was adopted unanimously by the 130th IPU Assembly (6). The discussion around the resolution highlighted the role of parliamentarians in reviewing legislation and policies to meet the unmet need for contraception as well as sexual and reproductive health services. The Department also collaborated with the IPU and the Pan African Parliament in the area of child, early and forced marriage, conducting a study on 10 African countries. The final report was presented at the Pan African Parliament, and was instrumental in the finalization of a Pan African Parliament resolution on gender-based violence. In collaboration with the IPU, the RHR Department also conducted a study on child, early and forced marriage legislation in 37 countries in Asia and the Pacific. The findings of the study were presented at a Regional Seminar for Asia-Pacific Parliaments, on the theme of “Ending the cycle of violence against girls in Asia- Pacific”, which was organized by the Parliament of Bangladesh in Dhaka (23–25 September 2014). The Department also provided technical support in the general discussion on violence against women and girls in the region. The Department also collaborated with other regional and thematic platforms on sexual and reproductive health issues. For example, we provided technical support to the Parliamentarian meeting on the occasion of the Conference on Family Planning in Addis Ababa, and to the International Parliamentarians’ Conference on the Implementation of the Programme of Action of the ICPD in Stockholm, both of which were organized by the European Parliamentary Forum (EPF). Annual Technical Report 20148 Other activities included collaboration with national Parliaments such as with the Parliament of Italy on violence against women, and with the Parliament of Bangladesh on adolescent health and child, early and forced marriage. Planned activities • In 2015, the Department will facilitate the participation of the WHO Director General at the next IPU General Assembly in March, and the engagement of parliamentarians in global health initiatives, such as the post-2015 development agenda, FP2020, the World Health Assembly, and the accountability mechanisms. • The Department also plans to finalize peer-reviewed papers in collaboration with the IPU on (i) child, early and forced marriage legislation in Africa, Asia and the Pacific; and (ii) the role of parliamentarians in the accountability frameworks for women’s and children’s health. • In addition, the Department will conduct the review of the 2012 IPU resolution on accountability for women’s and children’s health, and will expand policy research on the impact of legislation on sexual and reproductive health. 2.5 The Global Fund to Fight AIDS, Tuberculosis and Malaria The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) mobilizes, manages and disburses substantial resources for national HIV/AIDS, tuberculosis and malaria programmes. Although much progress has been made, the burden of these diseases is still substantial and disproportionately affects women, adolescent girls, newborns and children, especially in sub-Saharan Africa and South Asia. As the Global Fund does not have a permanent country presence, its success depends on the collaborative efforts of countries and technical and development partners, particularly WHO. WHO has signed an agreement with the Global Fund to provide country-specific technical support to increase the quality of RMNCH elements in the Concept Notes used to apply for Global Fund support. The RHR Department has contributed to providing technical support to countries in developing proposals that include sexual and reproductive health aspects. Progress Along with other key WHO departments and the Roll Back Malaria Partnership, WHO has convened and conducted four capacity-building workshops for RMNCH consultants, partners, ministry of health (MOH) focal persons and WHO staff, involving 23 countries in the African Region. Further, the Reproductive, Maternal, Newborn, Child and Adolescent Health (RMNCAH) Team participated in consultations organized in Burkina Faso, India South Africa and Uganda, to review draft Concept Notes developed by various countries. The Department also completed the WHO Technical Guidance Note: Strengthening the inclusion of reproductive, maternal, newborn and child (RMNCH) health in concept notes to the Global Fund (7). Several challenges have been identified during the provision of technical assistance, including: (i) lack of technical assistance requests for RMNCH strengthening from the Country Coordination Mechanism (CCM) or from MOHs; (ii) RMNCH is not included in the CCM; (iii) the predefined financial split among diseases does not incentivize the inclusion of RMNCH interventions in Concept Notes; and (iv) with insufficient resources to maintain the current disease funding status, it is difficult to expand activities to address RMNCH. High-level advocacy and input to global initiatives for sexual and reproductive health 9 The Department has also facilitated workshops and mock Technical Review Panel (TRP) reviews, including a peer review workshop held by the Global Malaria Programme and the Roll Back Malaria Partnership, in Kampala, 19–21 November 2014, for the countries planning to submit malaria Concept Notes in January 2015. This work includes funding a consultant to follow up with specific countries. More mock TRPs will be held in 2015. Planned activities • The Department will provide in-country technical assistance, including proactive facilitation of country dialogue (including programme split discussion) for countries in all WHO regions that are planning to submit Concept Notes in the 2015 submission windows for RMNCH and health systems strengthening. • Further, following discussions with the Global Fund Steering Committee on 10 December 2014, a decision was made to expand the scope of the agreement with WHO to cover grant making, in part to address the challenges identified above. • This confirms WHO as a more active partner in translating the concept notes reviewed by the TRP and the Grants Approval Committee (GAC) into nationally aligned and harmonized, disbursement-ready grants for Global Fund Board approval and grant signature. This also strongly positions the Department to help ensure inclusion of RMNCAH and communities, rights and gender elements in Concept Note policy and programming for effective implementation and maximal impact. 2.6 References 1. Accountability for women’s and children’s health: 2014 progress report. Geneva: World Health Organization; 2014 (http://www.who.int/woman_child_ accountability/about/COIA_report_2014.pdf, accessed 19 January 2015). 2. Sexual and reproductive health beyond 2014: equality, quality of care and accountability: position paper. Geneva: WHO; 2014 (http://apps.who.int/iris/ bitstream/10665/112291/1/WHO_RHR_14.05_eng.pdf, accessed 19 January 2015). 3. The Beijing Declaration and Platform for Action. Adopted at the 16th plenary meeting, on 15 September 1995 (http://www.un.org/womenwatch/daw/ beijing/pdf/BDPfA%20E.pdf, accessed 19 January 2015). 4. Women and health: 20 years of the Beijing Declaration and Platform for Action. Report by the Secretariat to the 136th Session of the Executive Board. Geneva: World Health Organization; 2014 (EB136/18; http://apps.who.int/gb/ ebwha/pdf_files/EB136/B136_18-en.pdf, accessed 19 January 2015). 5. Access to health as a basic right: the role of Parliaments in addressing key challenges to securing the health of women and children. Resolution adopted unanimously by the 126th IPU Assembly, Kampala, 5 April 2012 (http://www. ipu.org/conf-e/126/res-3.htm, accessed 19 January 2015). 6. Towards risk-resilient development: taking into consideration demographic trends and natural constraints. Resolution adopted unanimously by the 130th IPU Assembly, Geneva, 20 March 2014 (http://www.ipu.org/conf-e/130/Res-2.htm, accessed 19 January 2015). 7. WHO Technical Guidance Note: Strengthening the inclusion of reproductive, maternal, newborn and child (RMNCH) health in concept notes to the Global Fund. Geneva: World Health Organization; 2014 (http://www.who.int/reproductivehealth/ publications/health_systems/rmnch-global-fund/en/, accessed 20 January 2015). Annual Technical Report 201410 Thematic areas 11 3. Thematic areas 3.1 Family planning and contraception 3.1.1 Introduction Unmet need for contraception remains high in many settings. It is highest among the most vulnerable in society including adolescents, the poor, those living in rural areas and urban slums, migrants, refugees, people living with HIV, and internally displaced people. In 2012, an estimated 222 million women had an unmet need for contraception; that is, they were at risk of becoming pregnant while they did not wish to conceive, yet were not using a modern method to prevent pregnancy. Additionally, many women using contraceptives are not satisfied with their method, potentially putting them at risk for discontinuation without replacement with a more acceptable method, leading to unintended pregnancy. The mission of the Human Reproduction team in the area of family planning is to reduce the unmet need for family planning and contraception and thus to prevent unintended pregnancy. To achieve this objective, the RHR Department, including HRP, is implementing a collaborative, science-driven approach. This section reports on how, in 2014, this approach has translated into concrete and coordinated activities towards achieving the ultimate goal of reducing unmet need for contraception. Major achievements • Several research studies have been completed during 2014: – A multicentre randomized clinical trial of two hormonal implant contraceptives – Jadelle® (75 mg levonorgestrel) and Implanon® (68 mg etonogestrel) – in seven countries involving 2963 women showed similar efficacy and safety for both devices. – A feasibility study of a new indicator for assessment of unmet need for family planning was completed. The indicator was “percentage of women of reproductive age attending HIV care and treatment services with unmet need for family planning”. The study led to the development of a screening tool (by WHO in collaboration with partners) for measurement of the indicator. This tool can be used to collect routine data on family planning needs in a more sustainable way, and in a way that allows for these data to be aggregated in a health information system. – The sperm suppression study, using norethisterone enanthate (NET-EN) and testosterone undecanoate (TU), showed a low pregnancy rate (four pregnancies in 320 participant pairs). However, the high frequency of severe adverse events (such as mood changes and disturbances, emotional disorders, injection site reactions, muscle pain and weakness) needs to be re-examined before further research will be pursued. – A multicentre study on peri-coital use of levonorgestrel has shown a pregnancy rate of 13 among 330 participants, with minimal side effects. This implies the possibility of using a contraceptive product as needed, when one has coitus. Annual Technical Report 201412 • The process of updating the Medical eligibility criteria for contraceptive use is in progress. The HIV-related recommendations were released earlier than planned, on 24 July 2014, to respond to urgent country needs (in English and Russian). • During 2014, the Department launched guidelines on human rights and contraceptive services as well as information on and analysis of existing quantitative indicators in relation to contraceptive services based on human rights. The Department also developed a framework on ensuring human rights in contraceptive services and information. • The Implementing Best Practices (IBP) initiative worked with WHO regional and country offices to document best practices and introduce tools for scaling them up, supporting activities in over 25 countries. 3.1.2 Implementation research and development The key components of research and development work within this thematic area are: (i) research activities to strengthen the evidence-base on priority needs (i.e. operations/implementation and service delivery research, and clinical efficacy and safety research); (ii) identifying research gaps and elaborating funding strategies to meet these gaps; and (iii) research synthesis and updating of the guidance in a timely fashion. 3.1.2.1 UPTAKE Project – a health sector and community-based participatory approach in a human rights framework to increase met needs for contraception. The UPTAKE Project aims to address the unmet need for family planning/ contraception through a participatory approach involving the community and health-care providers within a human rights framework. The human rights framework used by this project takes into account barriers to accessing contraception at the level of policies and guidelines, but also addresses barriers at the health services and the community levels. According to the WHO’s guideline Ensuring human rights in the provision of contraceptive information and services (1), one of the key health and human rights standards that should be considered is participation. Meaningful participation includes the active involvement of individuals, communities or community-based organizations in the functioning of community health services or systems. Community participation is a key component in frameworks for improving the quality of services. To achieve the goal of addressing the unmet need for family planning and contraceptive services, the project will first develop an approach for engaging with communities and health providers. An intervention package will be developed during the formative phase using the approach that also takes into account the existing health systems, structures, relevant policy and existing human rights framework in the specific contexts, and then this package will be implemented in the intervention phase. Participation of individuals and communities in all stages of decision-making and implementation of policies, programmes and services is a precondition for sustainable development and for achieving the highest attainable standard of health. However, increasing community participation is not enough to ensure family planning and contraceptive programmes’ efficacy, uptake, feasibility and scalability. Health providers and the health system should be engaged. They will Thematic areas 13 ensure that the intervention is feasible and that it can be an integral part of the existing health system. Health-care provider and community engagement will lead to collaboration, shared understanding of quality of care and service provision, shared responsibility and continued partnership. The success of the project will be seen in a shared vision of and an improvement in quality of care in family planning and contraceptive services and information provision, which may lead to increased utilization of services, and higher satisfaction with services and method use. Progress • The UPTAKE Project is a multicountry research study that will be implemented in Kenya, South Africa and Zambia and is projected to take four and a half years. The project is currently under review by the Research Project Review Panel (RP2). • Formative phase activities have been initiated, including scoping reviews on community and health-care provider participation within family planning and contraceptive programmes and quality of care as defined by both the community and the health-care providers. • WHO convened the first Working Group meeting on 8–9 December 2014 where experts and partners reviewed the project protocol and planned activities. Planned activities • The formative phase will be completed in 2015. • The intervention phase will take place in 2016–2018. 3.1.2.2 Reviewing and generating evidence on financing mechanisms for sexual and reproductive health services and commodities including family planning In recent years, various family planning financing schemes have been developed and implemented to assist the poor and vulnerable, including voucher programmes, community-based insurance, and others. The evidence base supporting the implementation of these mechanisms, relating specifically to family planning/ contraception, is very limited, and where evidence exists it is often of low quality. The present initiative led by the RHR Department aims to strengthen the evidence base on financing mechanisms for family planning/contraception, and thus to provide governments, funding agencies and other donors with evidence- based guidance upon which future programmes and projects can be based. The Department will undertake systematic reviews of the existing evidence with the specific objectives of (i) identifying those areas in which the evidence base for financing of contraception is strong, (ii) identifying the current gaps in knowledge and potential research topics in health care financing in contraception, and (iii) serving as a basis for initiating dialogue on joint investment in research to fill the gaps identified by the systematic review process. Progress In response to a call for proposals from the RHR Department, five research teams were selected to conduct systematic reviews of financing mechanisms for family planning, namely: (a) voucher schemes, (b) performance-based financing, (c) conditional cash transfers, (d) community financing and community-based health Annual Technical Report 201414 insurance, (e) out-of-pocket payments and user fees. The first researcher meeting was held in October 2014, organized by the Department and the Alliance for Reproductive, Maternal and Newborn Health (RMNH Alliance). The key outputs of the meeting included agreement on the key outcomes, screening strategies, mechanism for grading the quality of evidence, and development of a common template for a data extraction form and reporting format. Planned activities • The reviews are currently under preparation. A second technical meeting of researchers is planned for early April 2015, to bring together the five teams to present and peer-review the draft findings, reflect upon and discuss their implications, identify evidence gaps and, most importantly, devise new and innovative research approaches to addressing the gaps in a coordinated manner. • After this meeting, there will be a large meeting of bilateral, multilateral and nongovernmental donors in the family planning community, which is tentatively planned for May 2015. The aim of this meeting is to present the results, identify gaps in the research, propose a research agenda to funders and ultimately to begin implementation of the findings. • The reviews and consolidated findings will also be published in a special issue of a leading peer-reviewed journal (under discussion), and disseminated through the websites and networks of the Department. 3.1.2.3 Demand-side financing project (voucher programme) for increasing demand and utilization of contraception Lack of access to affordable contraceptive services and commodities is contributing to unmet needs for family planning in many developing countries. Evidence on the best mechanisms to provide these affordable services and commodities to the underserved and poor are limited. Demand-side financing approaches have been implemented to increase access to and uptake of quality family planning services, improve maternal and child health outcomes and achieve national development goals in low-income countries. Progress Presently two quasi-interventional studies testing two different demand-side financing approaches with voucher schemes (multipurpose versus single vouchers) are being conducted in the Punjab province, Pakistan, with Population Services International (PSI) and Marie Stopes International (MSI) as implementing partners. The projects aim at evaluating the effectiveness of the voucher scheme approach in improving the uptake and continued use of modern contraception among the poor in targeted communities. The evaluation of the projects will contribute to evidence on the effectiveness of reducing barriers to health services by using vouchers programmes, integrating supply and demand components of health, and increasing enrolment into social insurance schemes. Two manuscripts describing the baseline data and the project’s research protocol have been published in peer-reviewed journals in 2014 (2, 3). Planned activities • Following the baseline survey in 2012, both implementing partners initiated the implementation phase of the project in January 2013, and this is expected to be completed by January 2015. Thematic areas 15 • Preparations are under way with implementing partners for the end line survey of the project sites. Ethical approval from WHO and local sites have already been obtained. The tentative plan is to start the end line evaluation in early 2015 and complete the data collection, cleaning and analysis and finalize the report by mid-2015. 3.1.2.4 Postpartum family planning operations research under Muskoka Under the agreement with the French Ministry of Foreign Affairs, the RHR Department is initiating a two-year operations research project focusing on meeting unmet need for contraception among women during the postpartum period. This activity is part of the overall work referred to as “Muskoka”, which has been implemented since 2011 by the Department in collaboration with the WHO Maternal, Newborn, Child and Adolescent Health Department, UNFPA, UNICEF and UN Women. The theme of postpartum family planning (PPFP) was chosen as a priority for operations research by the RHR Department’s family planning team with agreement by the French Government and partners due to the high rate of unmet need for contraception among postpartum women. Although many countries have developed health policies and norms that promote family planning as part of efforts to achieve Millennium Development Goals 4 and 5, often these policies are not explicit or enforced during the postpartum period. The core intervention of this study consists of implementing a package of family planning services beginning in the prenatal period and continuing through six months postpartum. The objective of the study is to contribute to meeting the family planning needs of women and couples by implementing a package of PPFP interventions within the health sector through an operations research study. Progress • A series of meetings have been convened within the family planning team and with the French Government to identify and agree on the research topic. • Two research centres that have already received Long-term Institutional Development (LID) grants from the Department were identified as potential collaborators for the study: Institut de Recherche en Sciences de la Santé (IRSS) in Burkina Faso, and the University Clinics in Kinshasa, Democratic Republic of the Congo. A first meeting of the Department’s team working with the research institutes took place on 4–5 November 2014 in Geneva, followed by site visits to both countries in December 2014. • The concept note was shared with the Muskoka technical committee in November 2014 and feedback was incorporated into the protocol. Planned activities • The protocol will be submitted to RP2 in January 2015. • A mapping exercise to identify study sites will take place in January 2015. • The formative phase and all preparations for the intervention will be completed by November 2015. 3.1.2.5 Feasibility, utility and effects of family planning counselling tools at the community level The positive role of counselling tools in communicating high-quality, useful and accurate information to family planning clients is well established. The Annual Technical Report 201416 RHR Department, in collaboration with the Population Council, conducted an evaluation determining the relative utility and acceptability of three simplified counselling tools designed for community health workers with limited education and training – (i) A guide to family planning for community health workers and their clients by WHO (4), (ii) The balanced counseling strategy: a toolkit for family planning service providers by the Population Council (5), and (iii) a hybrid version with key common features of both tools – as compared with the usual information material provided to community health workers in India (i.e. the control group). Progress The evaluation, conducted with a sample of 142 community health workers in India from 2011 to 2012, has shown that in almost all cases there were no major variations between the groups using the various counselling tools and the control group, and that community health workers were able to perform their counselling tasks appropriately and effectively when using the hybrid simplified tool, including facilitating the choice of an appropriate method and providing it, if available. Planned activities • Findings suggest that the availability of a counselling tool improves the quality of interaction between the service provider and the client. Accurate, standardized, structured and customized information tools on family planning are important instruments in helping service providers, particularly community health workers like the accredited social health activists or ASHAs, to save their time and energy in counselling. In turn, women are more likely to believe the authenticity of the information provided through tools that facilitate their decision-making. 3.1.2.6 Factors affecting access to emergency contraception in Malawi Emergency contraception (EC) has been useful in reducing unintended pregnancies due to contraceptive failure (e.g. missed pills, condom slippage or breakage). However, there is low utilization of EC drugs in many countries and by many sectors who need them such as those who have problems with contraceptive use and adolescents who may have infrequent sex. A prospective cross-sectional study was initiated in August 2014 to investigate factors affecting availability and utilization of EC (1.5 mg levonorgestrel [LNG]) among women aged 10–49 years in Malawi. Specific objectives of the study include: (i) to assess availability of LNG and determine the stock levels at pharmacies, central medical stores, clinics (public and private) and rape victim support units; (ii) to identify factors that affect availability of LNG; (iii) to identify levels and characteristics of training of pharmacists on the provision of EC; and (iv) to assess EC-related knowledge and experience of service providers in support units for victims of sexual assault. This project is supported by the UN Commission on Life- Saving Commodities for Women and Children on Contraception. Progress and planned activities • The study is being conducted in the main capital region of Malawi, and is expected to be completed in early 2015. The data will identify gaps in the process of making the drug available, which can be addressed by further research and policy change. Thematic areas 17 3.1.3 Clinical and biomedical research 3.1.3.1 ECHO (the Evidence for Contraceptive options and HIV Outcomes Trial) – a multicentre, open-label, randomized clinical trial comparing HIV incidence and contraceptive benefits in women using depot medroxyprogesterone acetate, levonorgestrel implants and copper intrauterine devices For more than 25 years, some epidemiologic studies conducted in a variety of contexts have suggested that women using depot medroxyprogesterone acetate (DMPA) may be at increased risk of HIV acquisition. The results across multiple studies have been mixed, however. As shown in a recent systematic review, although initial studies on the topic often assessed all hormonal contraceptive methods together (i.e. combined hormonal contraceptives and progestin-only contraceptives, with varying formulations and delivery systems), more recent studies have examined specific types of hormonal contraceptives separately (6). The majority of evidence on oral contraceptive pills suggests they do not increase the risk of HIV acquisition. Some studies suggest increased risk among users of injectable contraceptives, specifically DMPA. The limited amount of evidence that exists for NET-EN and the contraceptive implant suggests no harm. Progress The randomized clinical ECHO Trial will provide the most definitive information concerning the comparative risk of HIV acquisition and other risks and benefits resulting from use of DMPA or levonorgestrel (LNG) implants, with copper intrauterine devices (IUDs) as the control group. The ultimate goal of this study – which uses gold standard study design and methods – is to provide policy-makers, programme managers, family planning service providers, advocates, and women contraceptive users with conclusive information about the comparative risks associated with the use of a variety of effective contraceptive methods. This information, combined with contraceptive efficacy data for each method, will allow for better-informed family planning decision-making. This three-arm trial (DMPA, LNG implant, copper IUD) can provide the essential scientific evidence and will address the question of whether use of DMPA or the LNG implant increases the risk of HIV acquisition. To realise this study a consortium comprising major organizations has been set up. The ECHO Consortium was convened by the RHR Department, and it will be jointly led by FHI 360 and WHO, to coordinate the trial. Roles have been collectively defined by the team’s strengths, based on the matrix of organizations and individuals involved. Other roles for the Department in the Consortium were to convene and establish the first Data and Safety Monitoring Board meeting and participate in several committees, including the Protocol Design Team, the Site Selection Committee and the Contraceptive Training, Management and Safety Subcommittee. The Department is also convening an annual meeting for the ECHO trial, to discuss research updates relating to HIV/AIDS and family planning/contraceptives. The ECHO Trial will be conducted in 12 clinics in southern and eastern Africa. A protocol has been approved by RP2 and submitted to the WHO Ethics Review Committee (WHO- ERC). The Department is closely involved in the East London site in South Africa. Planned activities • Implementation of the study will start in July 2015. Annual Technical Report 201418 3.1.3.2 Multicentre randomized clinical trial of two implantable contraceptives for women: two-rod levonorgestrel implant (Jadelle®) and one-rod etonorgestrel implant (Implanon®) Contraceptive implants are increasingly popular in the world. Implanon® is a single- rod, implantable contraceptive that contains the progestin etonogestrel, providing contraceptive protection for up to three years. Jadelle® has two levonorgestrel rods and provides protection for up to five years. The safety and efficacy of single-rod versus two-rod implantable contraceptives were investigated in a multicentre clinical trial. Progress During the first quarter of 2014, the Department completed a multicentre, randomized clinical trial to assess the three- and five-year safety, efficacy and acceptability of the Jadelle® and Implanon® hormonal contraceptive implants. The study was conducted in seven countries: Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. In total, 2963 women have been randomized to one of the two implants, while 971 women using the copper IUD (TCu 380A) were enrolled as an age-matched cohort. An article presenting the baseline characteristics of the study groups was published in Contraception in 2013 (7). Results of the study indicating that both contraceptive implants are safe and highly effective for up to five years of use, and that their effects are rapidly reversible upon removal, were presented for the first time at an international conference on the occasion of the European Society of Contraception and Reproductive Health 13th Congress in Lisbon (May 2014). Planned activities • A manuscript reporting on the three-year follow-up of clients in the implant study will be submitted to a peer-reviewed journal in January 2015 • The main paper analysing of the results of the five-year follow-up period of the study will be submitted for publication by end of first quarter in 2015. 3.1.3.3 Sperm suppression using norethisterone enanthate and testosterone undecanoate Progress To expand contraceptive options for men, the Department initiated a phase II trial of a product that combines a progestin (norethisterone enanthate, known as NET-EN) and an androgen (testosterone undecanoate, or TU), as this product has been shown to induce sperm suppression. However, the high number of side-effects (such as mood changes, etc.) reported by participants in the trial led to recruitment being discontinued in 2012. An investigators meeting was convened in July 2014 to discuss the results of the study and the plans for their publication and dissemination. Analyses showed only four pregnancies among the 320 participating couples in the efficacy phase, and more adverse events were reported in some centres (e.g. Indonesia) compared to others (e.g. India). Planned activities • The study report of the efficacy and safety findings will be finalized by January 2015. • Serum hormone analyses and correlations with clinical findings are being completed as additional analyses. Thematic areas 19 • Dissemination and publication of the results will occur in 2015. 3.1.3.4 Peri-coital oral contraceptive use of levonorgestrel 1.5 mg A prospective, open-label, single-arm, multicentre “proof of concept” study has been conducted to evaluate if oral levonorgestrel (1.5 mg), taken around the time of intercourse, up to six times a month, can offer an acceptable level of safety and contraceptive efficacy. The study will provide preliminary data to justify a pivotal phase III study to establish efficacy and safety of possibly using other methods, such as ulipristal, and to inform policies and programmes worldwide Progress Recruitment and follow-up of 330 participants in four countries were completed in mid-2014, and all study sites were closed. Planned activities • An investigators meeting is scheduled in January 2015 to discuss the findings on the efficacy of the regimen and to look at the problems and difficulties in conducting the study • The report of study findings is expected to be submitted for publication by mid-2015. • Dissemination of study results is also planned at conferences in 2015. 3.1.4. Norms, standards and tools 3.1.4.1 Continuous Identification of Research Evidence (CIRE) and the family planning guidelines – revision of the Medical eligibility criteria for contraceptive use and Selected practice recommendations for contraceptive use In partnership with the United States Centers for Disease Control and Prevention/ WHO Collaborating Centre for Reproductive Health (CDC/WHOCC), the RHR Department uses the Continuous Identification of Research Evidence (CIRE) system to assure that WHO’s global family planning guidance is created – and maintained – based upon the best available published evidence since 2002. Regularly, the Department searches the PubMed bibliographic for newly published evidence (in any language) relevant to the Medical eligibility criteria for contraceptive use (8) and the Selected practice recommendations for contraceptive use (9, 10). Citations are uploaded and discussed for relevance and a systematic review is prepared (or updated) as needed and later submitted for expert peer review. Experts advise WHO on whether: (i) the current recommendation remains consistent with the body of evidence and no action is needed; (ii) the current recommendation is inconsistent with the body of evidence but the inconsistency is insufficient to warrant interim guidance; or (iii) the current recommendation is strongly inconsistent with the body of evidence and interim guidance should be issued. Progress The Guideline Development Group (GDG) convened twice during 2014 (9–12 March and 24–25 September) to review and, where appropriate, revise specific recommendations in the Medical eligibility criteria for contraceptive use (MEC) as well as in the Selected practice recommendations for contraceptive use (SPR). The GDG comprises an external, multi-disciplinary, gender- and regionally-balanced membership with a WHO Secretariat. Following requirements for guideline Annual Technical Report 201420 development established by WHO’s Guidelines Review Committee, the GDG considered the evidence summarized within systematic reviews prepared for the consultations and applied the Grading Recommendations, Assessment, Development and Evaluation (GRADE) approach to evidence review to formulate recommendations. Owing to the public health importance of recommendations on the use of hormonal contraceptive methods by women at high risk of HIV and women living with HIV, including women taking antiretroviral therapy, WHO released a technical statement with these recommendations on 24 July 2014 at the 20th International AIDS Conference in Melbourne, Australia (11). Planned activities • The finalized MEC revision is targeted for release in March 2015, during a PAHO/ WHO Regional Office for the Americas Regional Forum on Women’s Health. The publication of the revised SPR will follow in the summer of 2015. The revisions will be published on the Department’s website. Related counselling tools and job aids will be updated accordingly. • To facilitate the interpretation and adaptation of the MEC and SPR within national policies, an adaptation guide will be developed to assist national authorities to prepare and/or update family planning/contraceptive policies in their settings. WHO has observed that governments and implementing partners, as well as providers, are either not always aware of existing tools and guidelines, or are not effectively undertaking this activity. • In response to requests from Member States and professional organizations, a pocket guide containing essential service delivery recommendations in a user- friendly format for health-care providers, provisionally titled The contraceptive service delivery tool, will be prepared and field-tested for usability during 2015. This project has been underway since 2014 and will apply the updated SPR recommendations once they are issued. Tentatively, field-testing is planned in Bangladesh, the Democratic Republic of the Congo and Kenya. 3.1.4.2 Programming strategies for postpartum family planning Following childbirth, women often lack the support they need to space and limit future pregnancies. By addressing the unique needs of these women, postpartum family planning (PPFP) can help improve maternal, newborn and child health. The 2013 WHO publication, Programming strategies for postpartum family planning, outlines the important elements of a PPFP intervention, to help programme planners and managers identify opportunities to offer contraception to postpartum women within existing health systems (12). Progress Following the launching of the Programming strategies for postpartum family planning publication at the 3rd International Conference on Family Planning in Addis Ababa, Ethiopia (November 2013), translations of the document into French and Spanish were undertaken and completed in 2014.2 The French translation was released during a regional meeting of programme officers representing 14 francophone countries in February 2014, and the Spanish 2 All three language versions are available at: http://www.who.int/reproductivehealth/publications/family_ planning/ppfp_strategies/en/ Thematic areas 21 translation was disseminated through colleagues at PAHO/WHO Regional Office for the Americas. In addition, the English version of the programming resource was presented and disseminated during the 30th Triennial Congress of the International Confederation of Midwives in Prague, Czech Republic (June 2014), and during the Scientific Conference of the East, Central and Southern Africa College of Nursing meeting in Harare, Zimbabwe (September 2014). Planned activities • To enhance the usability of the Programming strategies for postpartum family planning document, as well as capitalize on the availability of other guidelines, tools and resources that complement the document, a consolidated PPFP package will be developed. • This resource will offer a compilation of WHO guidelines and programme resources addressing PPFP and, importantly, explain how programme managers and policy-makers can apply the materials to design and strengthen their programmes. 3.1.4.3 Human rights and contraception Unmet need for contraception remains high in many settings, and is highest among the most vulnerable in society: adolescents, the poor, those living in rural areas and urban slums, people living with HIV, and internally displaced people. The latest estimates are that 222 million (13) women have an unmet need for modern contraception, and the need is greatest where the risks of maternal mortality are highest. Progress In order to accelerate progress towards attainment of international development goals and targets in sexual and reproductive health, and in particular to contribute to meeting unmet need for contraceptive information and services, the World Health Organization (WHO) has developed guidelines and recommendations on Ensuring human rights in the provision of contraceptive information and services (1). These guidelines were launched in 2014 at a high-level event at the UN Human Rights Council, and have been disseminated to partners during the course of the year. In addition, the Department developed a framework on ensuring human rights in contraceptive services and information. The framework was also released in 2014 (14). Planned activities • In 2015, the Department has plans to work on strengthening normative standards for monitoring, evaluation and accountability at country, regional and global levels. In this regard, the Department will be working to strengthen monitoring and evaluation of human rights dimensions in contraceptive service programmes through development of a new tool, and to strengthen quality of care in contraceptive programmes through development of human- rights-based quality assessment. 3.1.4.4 Contraceptive services delivery in the Optimize MNH guidance document on task shifting/sharing Progress The WHO 2012 Optimize MNH guidance contains evidence-based recommendations for the safe provision of key maternal and newborn health interventions by different cadres of health workers (15). This document also Annual Technical Report 201422 summarizes the WHO recommendations on the cadres ranging from lay health workers to mid-level providers who may be trained and supported to conduct promotional activities and to provide the following contraceptive methods safely: tubal ligation, vasectomy, IUDs, implants and injectables. The process of enabling additional cadres to provide a specific health intervention is referred to here as “task shifting” but is also widely known as “task sharing”. WHO participated in a technical meeting in July 2014 organized by the United States Agency for International Development (USAID) and Marie Stopes International to discuss the development of these guidelines and to plan for future research to strengthen the evidence on task sharing. The process of enabling additional cadres to provide a specific health intervention is referred to here as “task shifting” but is also widely known as “task sharing”. WHO participated in a technical meeting in July 2014 organized by the United States Agency for International Development (USAID) and Marie Stopes International to discuss the development of these guidelines and to plan for future research to strengthen the evidence on task sharing. Planned activities • The outcome of the technical meeting was a recommendation for agencies supporting research on task sharing: to explore how present and future projects can contribute to addressing gaps in the guidelines agenda; to determine how to position studies to ensure policy change at the national level; to consider looking at other outcomes such as cost, impact on workforce, provider perspectives and effectiveness of interventions; and to consider other workforce sectors, such as pharmacists and suppliers of medicines to pharmacies. 3.1.5 Monitoring and evaluation 3.1.5.1 Human rights and family planning indicators The Department undertook a review of existing quantitative indicators for rights- based monitoring of contraceptive services and information; a report has been published in 2014 (16). A joint implementation guide for the WHO guidelines (Ensuring human rights in the provision of contraceptive information and services; 1) has been developed with UNFPA and will be released in 2015. WHO is also working closely with partners on the initiative led by Denmark and Ethiopia on family planning and contraception at the Human Rights Council. 3.1.5.2 Measuring need for family planning among women attending HIV services: a comparison of data collection methods There is an established need to identify more accurate methods for measuring the unmet need for family planning among women living with HIV. Therefore the Department conducted a study to compare how well the use of a simplified questionnaire (adapted from Demographic and Health Survey [DHS] questions) determined unmet needs when used by (i) health-care providers during their interactions with clients at the HIV clinic or (ii) external interviewers conducting exit interviews among women attending HIV care and treatment services. Progress Using a cross-sectional study design, 1186 women aged 15–49 years were interviewed only once, either during the provider contact or during the exit Thematic areas 23 interview at selected HIV care and treatment facilities with large client loads in Kenya, Uganda and Zambia. Data collection took place between March 2012 and February 2013. The study showed that providers’ use of this brief tool in allocating family planning need status is statistically equivalent to the allocations made by external, non-clinical interviewers. This implies that the tool can be used to collect routine data on family planning needs in a more sustainable way that can be aggregated in health information systems in order to monitor the progress in reducing unmet need for contraception among women living with HIV. The manuscript of the study has been written and submitted in 2014 for journal publication and we are awaiting comments. Planned activities • The study results will be published in 2015. 3.1.6 Dissemination and partnerships Work on dissemination and partnerships, is intended to support utilization of evidence in countries through systematic introduction of science-driven solutions to inform health policies. 3.1.6.1 Family Planning 2020 (FP2020) The Government of the United Kingdom and the Bill & Melinda Gates Foundation, in partnership with UNFPA, national governments, donors, civil society, the private sector, the research and development community, and others from across the world, called a global Family Planning Summit in London in 2012 to support the right of women and girls to decide, freely and for themselves, whether, when and how many children they have. The Summit gave rise to the Family Planning 2020 (FP2020) partnership and called for unprecedented global political commitments and resources, with the ultimate goal of supporting the rights of an additional 120 million women and girls in the world’s poorest countries to use contraceptive information, services and supplies, without coercion or discrimination, by 2020. The RHR Department has played a crucial role. Progress In the two years since the London Summit, FP2020 has made remarkable progress, including additional commitments from countries, increased disbursements from donors, and progress across multiple sectors. According to the latest progress report launched on 3 November 2014, across the 69 FP2020 focus countries, in 2013 8.4 million more women and girls are using modern contraception, more than 30 of those countries have made commitments to the FP2020 initiatives, and a total of US$ 1.3 billion has been provided by donor governments. The governing body of the FP2020 partnership is the Reference Group, which sets the overall strategic direction and drives coordination among the partnership’s stakeholders. The Reference Group has 18 members representing multilateral organizations, civil society, developing countries, donor governments and the private sector. It is accountable for ensuring the achievement of the FP2020 final goal. The current co-chairs of the Reference Group are Dr Chris Elias, President of Global Development at the Bill & Melinda Gates Foundation, and Dr Babatunde Osotimehin, Executive Director of the United Nations Population Fund (UNFPA). WHO, and in particular the RHR Department, has been on board since the inception of the initiative and has contributed actively. Dr Flavia Bustreo, Assistant Director- Annual Technical Report 201424 General of the Family, Women’s and Children’s Health Cluster at WHO, is a member of the Reference Group of FP2020, whereas RHR Director, Dr Marleen Temmerman, is the co-chair of the Performance, Monitoring and Evidence (PME) Working Group, together with a representative from the Population Council. The PME Working Group has provided technical advice and support to FP2020 in monitoring and evaluation of progress towards reaching the FP2020 goal, including the development of the progress reports for the first two years of the initiative. This task is developed in concert with two initiatives at the country level: Track2020 (led by the Futures Institute) and PMA2020 (led by the the Bill & Melinda Gates Institute for Population and Reproductive Health at the Johns Hopkins Bloomberg School of Public Health). The PME Working Group also has the mandate of strengthening accountability for implementing financial, policy and programming commitments made by country governments, donors, the United Nations, civil society and others. The Department has also provided technical support to the FP2020 Rights and Empowerment Working Group, to ensure that the FP2020 work on contraception and human rights are in line with the guidelines and framework recently developed by WHO (1, 14). 3.1.6.2 RHR Department Contributions to the UN Commission on Life-Saving Commodities for Women and Children Under the auspices of the UN Secretary-General’s Every Woman Every Child initiative, the Commission on Life-Saving Commodities for Women and Children was established to advocate at the highest levels for the increased availability, affordability and accessibility of essential but underutilized commodities, including contraceptives. Within the Commission, the RHR Department is part of the Technical Resource Team (TRT) for Contraceptives, which represents a merging of the previous TRTs on Emergency contraception, Female condoms and Hormonal contraceptive implants. In phase I of the TRT workplan, the focus was on global tools, policies and programme guidance. In phase II, the focus is now on service delivery and country-level programmes. Progress A review of the literature on best practices for increasing access to emergency contraception (EC) identified mostly studies on the knowledge, attitudes and practices (KAP) of providers and users, and studies on service provision and policy governance. For female condoms, the Department conducted and completed a desk review of surveys on KAP of female condom users and non-users in various countries with different levels of female condom use. In addition, a module on EC for the WHO/ USAID/UNFPA Training Resource Package for Family Planning (TRP), including a sub- module for pharmacists, was completed and posted on the TRP website.3 The consolidation of more of 20 TRTs into just 9 was carried out in early 2014. At a meeting convened at UNICEF, New York, workplans were consolidated and links between TRTs were established. The first phase of the TRT workplan was to be completed in 2013, but some activities were carried over into 2014, including the conduct of operations research, and the work on policy development activities. New activities in phase II which the Department will be leading include the dissemination of the training materials on EC and other contraceptives through 3 Available at: www.fptraining.org Thematic areas 25 the TRP for Family Planning, and the development of policy recommendations on improving access to the main commodities, in collaboration with the other TRTs. Planned activities • The carry-over activities of the phase I workplan will be completed in early 2015. • The implementation of phase II of the TRT workplan is expected to be completed by end of 2015. 3.1.6.3 Activities of the Implementing Best Practices initiative In 1999, WHO’s RHR Department, USAID, UNFPA and nine other agencies created the Implementing Best Practices (IBP) initiative to work at the global, regional and country levels to foster collaboration, reduce duplication and harmonize approaches to support the identification, implementation and scaling up of effective technical and managerial practices to improve reproductive health. With the IBP Secretariat based in the RHR Department, the partnership has grown to 44 organizations, allowing for close collaboration between the Department and the IBP partners. The IBP initiative is guided by its current five-year strategy and accompanying results framework. The objectives of the 2011–2016 strategy are to (a) actively engage in work of the IBP Consortium; (b) support sustained collaboration to scale up effective reproductive health/family planning practices at the country level; (c) scale up and document the learning in five priority countries; and (d) enhance knowledge sharing that improves access to, and application of, information and resources. Objectives are reached through a combination of activities, some of which are highlighted below. (i) Supporting countries and regional bodies to document, scale up and share effective reproductive health practices Progress (a) Documentation The IBP Consortium recognizes the need for countries and regions to capitalize on the experiences and lessons learnt within their own countries as well as within the region. It is now widely recognized that there is a need to document effective practices in countries in order to be able to build on these experiences by sharing at the country and regional level. This documentation requires an in-depth look at the implementation of the particular practice, with an eye to identifying the essential elements for successful implementation and approaches to overcoming barriers. After extensive consultation with the IBP Secretariat and partners, Zambia, IBP’s first focus country, completed documentation of “best practices” in family planning in October 2014. The purpose of the documentation was to identify practices which would be incorporated into the plan for the implementation of their eight-year family planning strategy (2013–2020). Our regional partner, the East, Central and Southern African Health Community (ECSA-HC), has also conducted a documentation activity. The tools used to document family planning best practices in Mauritius, Tanzania and Zimbabwe were based on the tools developed for the Zambia programme. The West African Health Organisation (WAHO) is also working with IBP to begin documenting good practice in the 15-country Economic Community of West African States (ECOWAS) region as a preparatory process for planning their upcoming Good Practice Forum, to be held in 2015. Due to the Ebola crisis, the Forum was postponed, but planning is still going ahead. Annual Technical Report 201426 (b) Scaling up Scaling up effective practices is the ultimate goal of the IBP initiative. The IBP’s publication, Guide to fostering change to scale up effective health services (17), which incorporates the WHO/ExpandNet tools – Beginning with the end in mind (18) and Nine steps for developing a scaling up strategy (29)44– continues to be the cornerstone of this work. In July 2014, the IBP Secretariat supported the Ministry of Health in Burkina Faso to plan for the scaling up of the WHO Individual, Family and Community Model, which is being tested and supported by Enfants du Monde, WHO in Burkina Faso and UNFPA. A plan was developed and is now being finalized and validated by stakeholders. Additionally, IBP supported the WHO Regional Office for Africa to conduct a workshop for 10 countries in eastern and southern Africa in February 2014 to introduce new family planning tools and guidelines as well as to orient participants to IBP, the Training Resource Package for Family Planning, the Guide to fostering change to scale-up effective health services, and approaches to the documentation of best practices. During site visits connected to the workshop, the Zimbabwe nursing student project – which was the result of high-level Zimbabwean government participation in the 2009 ”Fostering change” workshop with ECSA-HC – was highlighted. The programme has expanded from the initial site to five additional schools in Zimbabwe. A satellite workshop was also held at the 3rd International Symposium for Health Systems Research (September/October 2014). This workshop introduced the Guide to fostering change to scale up effective health services, while also presenting different experiences of scaling up. The discussions emphasized the essential elements of the approaches to scaling up. Planned activities • As a result of this documentation process in Zambia, IBP partners at the global, regional and country level will work with Zambia’s Ministry of Community Development and Maternal and Child Health to plan for scale-up of selected practices. • The Department will lead the IBP partners to work with ECSA-HC to review the results of their documentation exercise in Mauritius, Tanzania and Zimbabwe, and assist in dissemination and utilization of results in 2015. • The Department will also work with partners to support the planning and implementation of the WAHO Good Practice Forum. The first major planning activity will be held at the end of January 2015 and will focus on consolidating tools for documentation across the subregion as well as a prioritizing a list of “good” practices in family planning and other areas of reproductive health. (ii) Partnership and knowledge management Progress During 2014, Management Systems International (MSI), Education Development Center (EDC) and Ipas joined the IBP Consortium, bringing the total to 44 partner organizations. 4 English, French and Spanish versions of this are available at: http://www.who.int/reproductivehealth/publica- tions/strategic_approach/9789241500319/en/ Thematic areas 27 A new IBP website was launched at the June 2014 partners meeting. This website was reconfigured with assistance from Pathfinder International and using new software that makes it easy to adapt and update the site as needed. IBP Consortium semi-annual meetings were held in June and December. In June, the Consortium tried a new meeting format, with the theme of “Adolescents” for a full day of discussions. This meeting attracted the largest ever attendance, with 120 attendees. As a result, a new task team was formed to lead the partners in adolescent health issues. The Department’s Dr Chandra-Mouli, who was present at the IBP meeting, is the co-leader of this group along with Pathfinder. Their first task was to gather and make available tools and resources on scale-up of adolescent and youth sexual and reproductive health (AYSRH) practices, with a particular focus on reproductive health/ contraception, by the end of 2014. The theme of the December 2014 meeting was “Implementation science”, with a focus on understanding what this means for IBP and its partners. This meeting was held directly following the 7th Annual Conference on the Science of Dissemination and Implementation: Transforming Health Systems to Optimize Individual and Population Health, organized by Academy Health and the United States National Institutes of Health (NIH). The IBP Consortium created and uses a reliable, consistent knowledge management platform, the Knowledge Gateway. This tool is used by over 350 000 people worldwide, with approximately 55 000 focusing on reproductive health and family planning. Particularly active Communities of Practice (CoPs) include Post-Partum Family Planning (with over 1300 members from 87 countries), Family Planning Integration with Immunization, Systematic Approaches to Scale-up, and the Maternal, Infant and Young Child Nutrition and Family Planning. Each CoP organizes face-to-face and virtual meetings and posts relevant documents. This year, many of the CoPs decided to hold webinars with all preparation and follow-up discussions taking place on the Knowledge Gateway platform Planned activities • The Department will organize partners to plan for activities and sessions at the 4th International Family Planning Conference in Indonesia (November 2015). • The IBP Secretariat will continue to support partners to conduct discussion forums and initiate communities of practice on key reproductive health topics. (iii) Linkages to related activities in the RHR Department Progress The IBP Secretariat is responsible for the Department’s work with Muskoka funding for family planning in francophone West Africa. This work is also linked with the Ouagadougou Partnership, which focuses on supporting countries in this region with family planning. Aside from supporting countries to conduct activities related to high-impact interventions (such as community-based programmes, postpartum family planning, introduction of long-acting methods), the IBP Secretariat along with Department staff also supported the WHO Regional Office for Africa and three West African countries to begin planning for the scale-up of post-abortion care services, particularly focusing on the family planning element. Annual Technical Report 201428 Planned activities • Countries that participated in the WHO Regional Office for Africa workshop in Lomé, Togo (i.e. Chad, the Democratic Republic of the Congo and Togo) will be supported to scale up post-abortion care/family planning. • The IBP secretariat will support the launch of the updated Medical eligibility criteria for contraceptive use and conduct a meeting to discuss implications for implementation with IBP partners in March 2015. 3.1.7 References 1. Ensuring human rights in the provision of contraceptive information and services: guidance and recommendations. Geneva: World Health Organization; 2014 (http://apps.who.int/iris/bitstream/10665/102539/1/9789241506748_ eng.pdf, accessed 8 January 2015). 2. Azmat SK, Ali M, Hameed W, Mustafa G, Abbas G, Ishaque M, et al. A study protocol: using demand-side financing to meet the birth spacing needs of the underserved in Punjab Province in Pakistan. Reprod Health. 2014;11:11. 3. Hameed W, Azmat SK, Ali M, Sheikh MI, Abbas G, Temmerman M, et al. Women’s empowerment and contraceptive use: the role of independent versus couples’ decision-making, from a lower middle income country perspective. PLOS ONE. 2014;9(8):9. 4. A guide to family planning for community health workers and their clients. Geneva: World Health Organization; 2012 (http://www.who.int/reproductivehealth/ publications/family_planning/9789241503754/en/, accessed 9 January 2015). 5. Federico L, Vernon R, Martin A, Bruce L. The Balanced Counseling Strategy: a toolkit for family planning service providers. Washington (DC): Population Council; 2008 (http://www.popcouncil.org/research/the-balanced-counseling- strategy-a-toolkit-for-family-planning-service3, accessed 9 January 2015). 6. Polis CB, Curtis KM. Use of hormonal contraceptives and HIV acquisition in women: a systematic review of the epidemiological evidence. Lancet Infect Dis. 2013;13(9):797–808. 7. Meirik O, Brache V, Orawan K, Habib NA, Schmidt J, Ortayli N, et al.; WHO Study Group on Contraceptive Implants for Women. A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data. Contraception. 2013;87(1):113–20. 8. Medical eligibility criteria for contraceptive use, fourth edition. Geneva: World Health Organization; 2010 (http://www.who.int/reproductivehealth/ publications/family_planning/9789241563888/en/, accessed 8 January 2015). 9. Selected practice recommendations for contraceptive use. Second edition. Geneva: World Health Organization; 2004 (http://whqlibdoc.who.int/ publications/2004/9241562846.pdf, accessed 20 January 2015). 10. Selected practice recommendations for contraceptive use: 2008 update. Geneva: World Health Organization; 2008 (WHO/RHR/08.17; http://whqlibdoc. who.int/hq/2008/WHO_RHR_08.17_eng.pdf, accessed 12 January 2014). 11. Hormonal contraceptive methods for women at high risk of HIV and living Thematic areas 29 with HIV: 2014 guidance statement: recommendations concerning the use of hormonal contraceptive methods by women at high risk of HIV and women living with HIV. Geneva: World Health Organization; 2014 (WHO/RHR/14.24; http://www.who.int/reproductivehealth/topics/family_planning/hc_hiv_ statement/en/, accessed 9 January 2015). 12. Programming strategies for postpartum family planning. Geneva: World Health Organization; 2013 (http://www.who.int/reproductivehealth/ publications/family_planning/ppfp_strategies/en/, accessed 9 January 2015). 13. Singh S, Darroch JE. Adding it up: cost and benefits of contraceptive services – estimates for 2012. New York (NY): Guttmacher Institute; 2012. 14. Framework for ensuring human rights in the provision of contraceptive information and services. Geneva: World Health Organization; 2014 (http://apps. who.int/iris/bitstream/10665/133327/1/9789241507745_eng.pdf, accessed 27 January 2015). 15. WHO recommendations: Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting. Optimize MNH. Geneva: World Health Organization; 2012 (http://apps.who.int/iris/ bitstream/10665/77764/1/9789241504843_eng.pdf, accessed 12 January 2015). 16. 16. Ensuring human rights within contraceptive programmes: human rights analysis of existing quantitative indicators. Geneva: World Health Organization; 2014 (http://www.who.int/reproductivehealth/publications/family_planning/ contraceptive-programmes-hr-analysis/en/, accessed 14 January 2015). 17. World Health Organization (WHO)/IBP. Guide to fostering change to scale up effective health services. Geneva: WHO; 2013 (http://www.who.int/ reproductivehealth/publications/health_systems/guide-fostering-change/ en/, accessed on 20 January 2015). 18. World Health Organization (WHO)/ExpandNet. Beginning with the end in mind: planning pilot projects and other programmatic research for successful scaling up. Geneva: WHO; 2011 (http://www.who.int/reproductivehealth/publications/ strategic_approach/9789241502320/en/, accessed 27 January 2015). 19. World Health Organization (WHO)/ExpandNet. Nine steps for developing a scaling-up strategy. Geneva: WHO; 2010 (http://www.who.int/reproductivehealth/ publications/strategic_approach/9789241500319/en/, accessed 20 January 2015). 3.2 Adolescent sexual and reproductive health 3.2.1 Introduction One of the key priorities for the work of the RHR Department, including HRP, is adolescent sexual and reproductive health (ASRH). The range of related activities include research and research synthesis, developing norms and guidelines, supporting monitoring and evaluation, and promoting implementation of evidence-based interventions, including through advocacy and partnerships with the aim of improving ASRH and contributing to the reduction of unintended pregnancies and unsafe sexual behaviours. Annual Technical Report 201430 The following sections summarize the key activities that have been carried out and the products that have been delivered during 2014, as well as the plans for 2015 to achieve the above goals and related objectives of the Department. Major achievements • Two research protocols for testing the effectiveness of interventions to reduce unintended pregnancy in adolescents were developed and fieldwork was initiated. • The Global Early Adolescent Study (GEAS), exploring gender norms and healthy sexuality among early adolescents, was extended to 10 countries where data collection efforts were initiated in 2014. • Six papers reporting evidence on key ASRH issues were published in peer- reviewed journals, and a special supplement of the Journal of Adolescent Health, reviewing the progress made in various aspects of ASRH and rights in the 20 years since the International Conference on Population and Development (ICPD) was published and launched at multiple high-level meetings. 3.2.2 Research and development 3.2.2.1 Intervention research to reduce adolescent risk behaviour and prevent pregnancy (i) Adolescent Health Experience After Delivery – the AHEAD trial Unintended pregnancy among adolescents (aged 10–19 years) is a common public health problem globally, and is associated with significant health risks and social costs. In low- and middle-income countries, complications from pregnancy and childbirth are among the leading causes of death for adolescents. Adolescents who have had one unintended pregnancy are at high risk for a rapid, repeat pregnancy (defined as a subsequent pregnancy within two years). Reported rates of rapid, repeat pregnancies among adolescents range from 20% to 50%. Progress The Department initiated a research study seeking to identify effective interventions to prevent rapid, repeat pregnancies in adolescents. Following input from a technical advisory group, a phase 1 protocol to investigate a complex intervention to prevent rapid, repeat pregnancy was developed. The core protocol has been approved by the HRP Research Project Review Panel (RP2) and the WHO Ethics Review Committee (WHO-ERC). A country-specific protocol has been developed for Ghana, and protocols are being developed for Malawi and Mexico, with a target deadline of 31 December 2014. A site visit to Ghana and submission to the country Institutional Review Board (IRB) occurred in November 2014 and the protocol was approved. Planned activities • Site visits to Malawi and Mexico are planned for January 2015. • Data collection will begin in February 2015. • We anticipate results from phase 1 for these two countries in the early autumn of 2015, and will work to develop the protocol for phase 2 throughout 2015. Thematic areas 31 (ii) Prevention of first pregnancy – systematic review and conceptualization A recent systematic review showed that most interventions designed to increase contraceptive use among young people were not successful (1). There are three key problems with designing interventions to reduce pregnancies among adolescents. First, unlike for other populations at risk for unwanted pregnancy, most adolescents do not visit health-care facilities. Second, in many settings, sexual activity before marriage is not socially acceptable, and therefore the numbers of adolescents at risk for unwanted pregnancy are significantly underreported. Third, evidence suggests that even if adolescents seek services at health-care facilities, providers are often inadequately trained to assist them or are biased against providing appropriate counselling and a wide range of contraceptives. Progress Given these three key barriers and evidence from previous research, the Department plans to initiate a multi-country school-based intervention study. In the study locations, comprehensive sexuality education (CSE) would be provided in all schools in selected locations, while selected intervention schools would also provide contraceptive counselling and provision of contraceptive methods (or referral to a nearby facility with health-care providers who are well trained to provide unbiased contraceptive services to adolescents). School- based interventions will reach the majority of adolescents, since the majority of adolescents are in school in most low- and middle-income countries. Planned activities • We plan to hold a meeting for donors and stakeholders about the proposed intervention study in the first half of 2015. (iii) Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes – the ARMADILLO study The Scientific and Technical Advisory Group (STAG) has recommended that the Department explore and capitalize on the diverse ways in which young people use mHealth interventions to access sexual and reproductive health (SRH) information and services. Therefore, the Department has developed a concept for a study assessing the coverage, impact and cost-effectiveness of a text-message-based platform delivering SRH information on demand to youth. Progress The phase 1 formative protocol to develop message content and to pilot-test the platform has been approved by RP2 and submitted to WHO-ERC. A country-specific protocol for this initial formative phase has been developed for Kenya, and has also been approved by a local IRB. A second study site is currently being identified. A meeting of country principal investigators and study partners took place in Geneva in November 2014. At this meeting, plans for phase 1 implementation were finalized and study designs for phase 2 assessments of coverage, impact, and cost- effectiveness were discussed in detail. Phase 2 protocol development is underway. Planned activities • Implementation of phase 1 in Kenya is expected to begin in the first quarter of 2015. Annual Technical Report 201432 (iv) Formative research to shape an intervention study on delivering adolescent health interventions alongside HPV vaccination in Tanzania Working in conjunction with the Department of Immunization, Vaccines and Biologicals, the RHR Department supported the Faculty of Infectious and Tropical Diseases, at the London School of Hygiene and Tropical Medicine, London, United Kingdom, and the Mwanza Intervention Trials Unit, at the National Institute for Medical Research, Mwanza, Tanzania, to carry out formative research for a proposed intervention trial to test the feasibility and acceptability of delivering adolescent health interventions (AHIs) alongside vaccinations for human papillomavirus (HPV) in Tanzania. The project explored the feasibility of integrating an adolescent health package with HPV vaccination through a three-step process: (a) a desk review of 39 policy documents; (b) a national stakeholder meeting with 37 policy-makers and partners; and (c) 18 key informant interviews with health and education policy-makers and district officials to explore perceptions of current programmes and AHIs that might be suitable for integration with HPV vaccination. Progress The formative research found that 13 school health interventions (SHIs) or AHIs are currently being implemented by the Government of Tanzania, mostly as vertical programmes. Coverage of current programmes is not universal, and is limited by financial, human resource and logistic constraints. Limited community engagement due to negative rumours and lack of strategic advocacy has affected uptake of some interventions, such as tetanus toxoid (TT) immunization. Overall, stakeholders and key informants considered deworming, vitamin A supplementation, TT vaccination and reproductive health education as the most suitable interventions for integrated delivery with HPV vaccination. However, other key stakeholders questioned whether linking deworming, which can be associated with side-effects, with HPV vaccination would be a good idea, and pointed out that vitamin A supplementation is not currently recommended by the Ministry of Health for children of primary school age. The research team therefore recommended exploring the possibility of screening short health promotion films followed by having a health worker available to answer questions, and TT vaccination being offered to girls in Standard VI (ages 13–14 years) and HPV vaccination being offered to girls in Standard IV (ages 9–10 years). The research team concluded that given programme constraints, limited experience with integrated delivery and concern about real or perceived side- effects being attributed to the HPV vaccine, it would be very important to pilot- test the integration of AHIs/SHIs with HPV vaccination. Selected interventions would need to be simple and quick to deliver since health workers are likely to face significant logistical and time constraints during vaccination visits. Planned activities • In 2015, based on the findings of the formative research, the Department will continue to support the development of a protocol for the pilot-test phase of this project. For further information on HPV and cervical cancer, please refer to section 3.6: Cervical cancer. Thematic areas 33 3.2.2.2 Descriptive research on adolescent development (i) Global Early Adolescent Study The RHR Department has collaborated with the Johns Hopkins Bloomberg School of Public Health in developing this large international study exploring gender norms and healthy sexuality among early adolescents, aged 11–13 years. The study seeks to (a) describe gender socialization as an evolving process in different cultural settings from early to late adolescence; (b) investigate parental/caregiver and peer influences on gender socialization of young adolescents; (c) understand how the different contexts (schools, neighbourhoods, media, culturally diverse settings) within which a young adolescent develops moderate parental/caregiver influences on gender socialization; and (d) understand how gender socialization in early adolescence influences sexual behaviours and gender-based violence in middle and late adolescence. The GEAS is divided into two phases. As part of phase 1, a set of cross-culturally appropriate and valid instruments applicable to early adolescents in urban poor settings are being developed. Phase 2 of the study will be a longitudinal study of early adolescents using the tools developed in phase 1. The study is being carried out in urban poor areas of 10 cities: Assuit (Egypt); Baltimore (USA); Blantyre (Malawi); Cape town (South Africa); Edinburgh (Scotland); Gent (Belgium); Ile Ife (Nigeria); Nairobi (Kenya); New Delhi (India); and Shanghai (China). These sites have been selected because they each have large populations of urban poor youth. They also represent a diverse range of cultural, geographic, ethnic and racial settings. Finally, there is a long history of research collaboration with organizations in each site. Other sites are likely to be added in Bolivia, Ecuador and Viet Nam. Progress In 2014, ethical clearances were secured by WHO and the Johns Hopkins Bloomberg School of Public Health Ethics Committees, and by the country sites, and steady progress was made in preparing for phase 2 of the project and in the development of the following tools: • a semi-structured qualitative in-depth interview protocol to explore transitions into early adolescence, gendered messages, changing relationships and intergenerational similarities and differences experienced between parents and their adolescent children; • a vignette-based instrument to measure gender norms contextualized by specific relationship portrayals; • a multidimensional scale to measure overall gender norms contextualized by relationship portrayals; • a survey instrument to assess early adolescent health behaviours and influencing factors. Planned activities • In 2015, the study tools will be finalized and data collection will be initiated. Annual Technical Report 201434 3.2.2.3 Secondary data analyses on access, quality and use of ASRH services (i) Analyses of access, quality and use of ASRH services in Mexico Progress Three separate analyses have been conducted using a large national population- based survey in collaboration with the National Institute of Public Health in Cuernavaca, Mexico. The topics are: • contraceptive knowledge and utilization among adolescents in Mexico; • perceived quality of sexual and reproductive health services by age in Mexico; • postpartum contraceptive use among adolescents compared with young women in public hospitals in Mexico. The analyses of the first two topics are still ongoing and will be completed in 2015. The results of the third analysis show that overall 43% of women who delivered in health-care facilities left the place of delivery without a contraceptive method. The proportion was highest among the adolescents aged 12–19 years (48%) compared with women aged 20–29 years (43%) and women aged 30–49 years (41%), but the difference was not statistically significant (P = 0.05). Place of delivery (public versus private hospitals) was significantly associated with postpartum contraceptive use by adolescents, with this being less common for those who delivered at public hospitals. A manuscript reporting the findings has been prepared and submitted for publication in a peer-reviewed journal (2). Planned activities • In 2015, after completion of the analysis, manuscripts on the other two topics will also be submitted for publication. The findings from all of these analyses will be used to inform the protocol development of phase 2 of the AHEAD trial, which is planned for 2015. (ii) Systematic review on menstruation and health in adolescent girls in low- and middle-income countries Progress As part of its work to strengthen the evidence base on very young adolescents, the Department carried out a systematic review to understand the knowledge, sources of information, health and social effects, and adults’ response to menarche, menstrual hygiene and menstrual health in adolescent girls. The review – which included 80 papers from 25 low- and middle-income countries – showed that many adolescent girls start their periods uninformed and unprepared. Mothers are the primary source of information for these girls but the information they provide is too little and too late, and often mothers pass on their own misconceptions. Because menstruation is widely seen as polluting and shameful, menstruating girls are often excluded and shamed in their homes and in their communities. Many do not have the means for self-care and do not get the support they need when they face problems. This hinders their ability to carry on with their everyday activities and may establish the foundation for life-long disempowerment. The findings were shared widely with partners, including UNICEF and UNESCO, to inform their related work. Thematic areas 35 (iii) Literature review on contraceptive use among adolescents in low- and middle-income countries Progress The Department carried out a review on contraceptive use in adolescents to determine the contraceptive needs of adolescents in developing countries, to identify barriers that adolescents encounter in accessing and using contraception, and to identify effective interventions to increase access and use of contraception among adolescents. The main findings included: • A significant number of adolescents are sexually active, and this increases steadily from mid- to late adolescence. • All adolescents in low- and middle-income countries – especially unmarried adolescents – face a number of barriers in obtaining contraceptive methods and in using them correctly and consistently. Adolescents experience many of the same barriers that adults do in accessing contraception, but some of the barriers are specific to adolescents. And even when adolescents do obtain contraception, social pressure may prevent them from using it. • Contraceptive use in adolescents could be increased by implementation of: favourable laws and policies; multifaceted communication programmes directed at community leaders and members, and at adolescents (i.e. programmes that inform, educate and create supportive norms for the provision and use of contraception); accurate and age-appropriate curriculum- based sexuality education; and the provision of a wide range of contraceptive methods through different adolescent-friendly outlets. The review was published in Reproductive Health and has been accessed nearly 11 500 times since it was published in January 2014 (3). 3.2.3 Norms, standards and tools 3.2.3.1 Ethical guidance for research on adolescents Progress The draft document on this topic produced at the end of 2013 was reviewed internally and externally during 2014. The feedback was collated and carefully considered. Planned activities • A revised draft was prepared, which will be published and disseminated in 2015. 3.2.3.2 Digitization of the quality assessment guide Progress As part of an effort to improve the quality of adolescent-friendly health services, the Department commissioned the digitization of an existing quality assessment guidebook. The digitized guidebook provides instant scoring, with data tracking available from the most local level up to municipal, state and national levels. Health managers are provided with instant feedback and the ability to chart progress over time. Annual Technical Report 201436 The Department has partnered with the Brazilian Ministry of Health (MOH) to translate the guide into Portuguese and build a website for roll-out in Brazil. In 2014, a meeting in Goiania, Brazil, with representatives from the MOH and adolescent health-care providers from each state, resulted in a draft version of the website being field-tested with feedback collated and passed to the web development team. The translation of the forms into Portuguese took place in September, and weekly meetings resulted in the linking of facility identity numbers to the website. The full tool was pilot-tested in six clinics in December 2014 and January 2015. Planned activities • Finalization of the tool is expected following a February 2015 meeting in Geneva. 3.2.4 Monitoring and evaluation 3.2.4.1 Documenting the scale-up of programmes providing ASRH services In most low- and middle-income countries, initiatives to provide adolescents with sexual and reproductive health education and services have been in the form of pilot projects – they are small, piecemeal and short-term. In a slowly growing number of countries, these initiatives have evolved from pilot projects to become large, comprehensive and sustained programmes. It is important to document how these countries have managed to scale up their programmes when so many others were unable to do so. These initiatives are often briefly described at seminars and workshops but there is generally little about them in the published literature. Unlike formal intervention studies, the evolution of these programmes is often slow and “messy”; it is a challenge to prepare succinct case studies that truly reflect their complex journeys. As a result, valuable lessons that could be learnt are not distilled and shared. Progress The Department has identified a number of countries that have implemented large and sustained sexual and reproductive health service and education programmes for adolescents and has synthesized the information about their efforts, especially efforts to overcome barriers to successful scale-up, using a modified version of the WHO-ExpandNet framework on scaling up health innovations. The following regions and countries were included in this work:5 • Americas: Argentina, Brazil, Colombia*, Ecuador • Africa: Mozambique*, Nigeria*, Rwanda, Senegal • Europe: Estonia*, Moldova* • South-East Asia: India (selected states) • Eastern Mediterranean: Pakistan* (selected provinces) • Western Pacific: Mongolia. As a result of this work, two articles have been published in peer-reviewed journals covering findings from Estonia and Nigeria (4, 5), and a number of others are due to be published shortly. The summary of the study on Colombia is presented in Box 1 (6). 5 * indicates completed/nearly completed Thematic areas 37 Planned activities In 2015, the Department is planning a consultation to bring together representatives from these countries to share the lessons learnt from their experiences. Box 1: Scaling up youth-friendly sexual and reproductive health services in Colombia – a case study Young people make up a quarter (24.5%) of Latin America’s population. Inadequate supply of specific and timely sexual and reproductive health (SRH) services and sexual- ity education for young people increases their risk of sexual and reproductive ill health. Colombia is one of the few countries in Latin America that has implemented and scaled up specific and differentiated health and SRH services: the Youth Friendly Health Services (YFHS) Model. Research was conducted to provide a systematic description of the crucial factors that fa- cilitated and hindered the scale-up process of the YFHS Model in Colombia. This included a systematic and comprehensive literature search on SRH services for young people and national efforts to improve the quality of care in Colombia and neighbouring countries, as well as interviews with a selection of key stakeholders. The information gathered was analysed using the WHO-ExpandNet framework. In seven years of implementation of the YFHS Model in Colombia (2007–2013), more than 800 clinics have been made youth-friendly. By 2013, 30 departments and 536 municipali- ties had YFHS, thereby achieving 46.9% geographic coverage of the municipalities. The analysis identified five elements that enabled the scale-up process: clear policies and implementation guidelines on YFHS; clear attributes of the user organization and resource team; establishment and implementation of an intersectoral and interagency strategy; identification of and support to stakeholders and advocates of YFHS; and solid monitoring and evaluation. The elements that limited or slowed down the scale-up effort were: insufficient numbers of health personnel trained in youth health and SRH; high turnover of health personnel; a decentralized health security system; inadequate supply of financial and human resourc- es; and negative perceptions among community members about providing SRH informa- tion and services to young people. In conclusion, Colombia’s experience shows that successful large-scale implementation of youth health programmes depends on clear policies and implementation guidelines, championship by institutional leaders and authorities in YFHS, continuous training of health personnel, and inclusion of users in the design and monitoring of these services. Source: Huaynoca et al., 2015 (6) 3.2.4.2 Evaluating ASRH and sexuality education programmes to understand the challenges to implementation and scale-up Progress The Department has supported programmatic evaluations to understand the challenges to implementation and scale-up of ASRH and sexuality education programmes, and how these challenges are being overcome. (i) External review of the Healthy Generation project: youth-friendly health services in Moldova The review of this project, which is supported by the Swiss Development Cooperation, identified three key findings that led to immediate action to improve services. Firstly, youth-friendly health centres were not mandated to deliver the full package of services and therefore services were often limited to the provision of information and counselling. While a specific package of services to be provided by the youth-friendly health centres had been defined by the MOH, the centres Annual Technical Report 201438 were not authorized to provide the required clinical services to adolescents and had to refer their clients to specialized centres for diagnostic and treatment services, thus undermining the central idea that the youth-friendly health centres are supposed to provide a full package of services in one place, while guaranteeing confidentiality and privacy. Secondly, among the assessed centres, the ones that were initially founded as nongovernmental organizations (and subsequently designated as youth- friendly health centres by the MOH) outperformed the newer public sector centres in relation to the six national quality standards and particularly in relation to friendliness and acceptability, raising questions on how to best increase motivation and improve health worker performance in the public sector. Thirdly, while the explicitly stated objective of the project was to “improve the sexual and reproductive health of young men and women in Moldova, particularly those who are vulnerable and most at risk”, no specific activities were planned or carried out to reach vulnerable and most-at-risk adolescents and no data were available on how many adolescents reached by the project belonged to this group. (ii) Evaluation of the Tarunya project in Jharkhand State, India: supporting the implementation of the ASRH project The Department was commissioned to conduct an evaluation of the ASRH project in Jharkhand State, north-west India, which is supported by the Tarunya project, funded by the Packard Foundation. The specific objectives of the evaluation were to study the project’s design, implementation, monitoring and outputs. The outputs of interest included improvements in the provision of quality health services, community support, adolescent awareness and adolescent demand for services, behavioural outcomes and health impacts, as well as strengthening of the relevant policies, planning, management and institutionalization. Field activities were completed in 2014. The results indicate that the Tarunya project improved the quality of health service provision in the following ways: it improved adolescent awareness on some aspects of ASRH; to a lesser extent, it improved adolescent demand for ASRH services; it strengthened policies, planning and management at state, district and local levels; and it brought the institutionalization of some of these changes. However, the state ASRH programme, implemented with support from the Tarunya project, had limited effects on the health behaviours of adolescents, including their health-seeking behaviours. 3.2.5 Dissemination and partnerships 3.2.5.1 Twenty years after International Conference on Population and Development – the status of adolescent sexual and reproductive health and rights Progress In 2014, the world commemorated the 20th anniversary of the ICPD, which took place in Cairo in 1994. In response to recommendations from the STAG and the Gender and Rights Advisory Panel (GAP), the Department reviewed the progress made in adolescent sexual and reproductive health and rights in the 20 years since the ICPD. In collaboration with UNFPA and the International Women’s Health Coalition, the Department reviewed the progress and evidence in the following ASRH-related areas: Thematic areas 39 • creating an enabling environment for ASRH: a framework and promising approaches; • sexuality education: emerging trends in evidence and practice; • effective strategies to provide ASRH services and to increase demand and support; • ensuring youth rights to participation, and promotion of youth leadership in the development of sexual and reproductive health policies and programmes; • addressing intimate partner violence and sexual violence among adolescents: emerging evidence of effectiveness. The findings of the reviews were reported within a special supplement of the Journal of Adolescent Health, pre-published online in December 2014 (7). Launch events were organized in collaboration with partners in a number of North American and European cities. Key messages from the special supplement issue were also presented at a number of international meetings. Planned activities • In 2015, data and evidence from the work on ASRH will be disseminated through key international activities and large conferences, including the XXI Congress of the International Federation of Gynecology and Obstetrics (FIGO), and other large scientific and policy events. 3.2.6 References 1. Hindin, MJ, Fatusi, A. Exploration of young people’s sexual and reproductive health assessment practices. MacArthur Foundation; 2014 (http://gatesinstitute. org//content/exploration-young-peoples-sexual-and-reproductive-health- assessment-practices, accessed 12 January 2015). 2. Darney B, Sosa-Rubi S, Servan-Mori E, Rodriguez MI, Walker D, Lozano R. Post- partum contraception prior to discharge in Mexico: association with age and place of delivery. Obstet Gynecol. 2015 (in press). 3. Chandra-Mouli V, McCarraher DR, Phillips SJ, Williamson NE, Hainsworth G. Contraception for adolescents in low and middle income countries: needs, barriers, and access. Reprod Health. 2014; 11:1. doi:10.1186/1742-4755-11-1. 4. Kempers J, Ketting E, Chandra-Mouli V, Raudsepp T. The success factors of scaling-up Estonian sexual and reproductive health youth clinic network – from a grassroots initiative to a national programme 1991–2013. Reprod Health. 2015;12:2. doi:10.1186/1742-4755-12-2. 5. Huaynoca S, Chandra-Mouli V, Yakub N, Denno DM. Scaling up comprehensive sexuality education in Nigeria: from national policy to nationwide application. Sex Education. 2014;14:191–209. 6. Huaynoca S, Svanymry J, Chandra-Mouli V, Moreno DJ. Documenting good practices. Scaling up sexual and reproductive health services in Colombia. Reprod Health. 2015 (in press). 7. Special Issue: The International Conference on Population and Development. Supplement to J Adolesc Health. 2015;56(1):Supplement S1–S60 (http://www. jahonline.org/issue/S1054-139X(14)X0004-2, accessed 20 January 2015). Annual Technical Report 201440 3.3 Maternal and perinatal health 3.3.1 Introduction In 2014, WHO’s work on maternal and perinatal health gained significant impetus with the launch of two key global initiatives. The consensus statement on Ending Preventable Maternal Mortality (EPMM) set a vision for maintaining the momentum and achieving further reductions in maternal deaths, and the Every Newborn action plan set the focus on a key component of infant mortality namely, newborn deaths (1, 2). Both initiatives focus on improving quality of care as well as reducing inequities in accessing care. The RHR Department’s, including HRP’s, research and normative work reflects the new agenda. Care during childbirth is the most critical period in this context. Key areas of work include promoting respectful care and reducing unjustified medicalization for mothers, and reducing stillbirth and intrapartum- related morbidity and mortality for babies. As presented to and endorsed by the Scientific and Technical Advisory Group (STAG) in 2014, research priorities are to improve the quality of care during childbirth and provide guidance on caesarean section. The research and guidance activities are carefully integrated in this context. For example, the findings of the intrapartum care research project will be complemented with evidence-based guidance during childbirth. Similarly, the work on caesarean section will be complemented by WHO guidance on strategies to reduce unnecessary caesarean sections and a monitoring and evaluation tool on the implementation of the Robson classification of caesarean sections. The antenatal care (ANC) guidance is a complex multidimensional project that will continue in 2015 with some specific outputs. It is anticipated that the quality of care work will be expanded to include work on preterm birth following the publication of the WHO guideline in 2015. Major achievements • Secondary analyses of data from the WHO Multicountry Survey on Maternal and Newborn Health were published as a special supplement of the BJOG: An International Journal of Obstetrics and Gynaecology, and in articles published in other journals. An important finding was the significant under-utilization of antenatal corticosteroids in women delivering preterm babies. • In fistula care, short-term catheter stay after surgery was found to be non- inferior to the more conventional two-week catheter stay in the largest fistula care trial to date (publication forthcoming). • The WHO Fetal Growth Study recruitment was completed, with data gathered from 1440 women in 10 countries. • Systematic analysis of causes of maternal deaths published in 2014 indicated that indirect causes and obstetric haemorrhage were the leading causes. WHO recommendations for augmentation of labour were published. • The WHO statement on the prevention and elimination of disrespect and abuse during facility-based childbirth has been endorsed by more than 70 organizations. • In May 2014, estimates of maternal mortality, including trends from 1990 to 2013, were published. Globally, there were an estimated 289 000 maternal deaths in 2013, a decline of 45% from 1990. Thematic areas 41 3.3.2.1 Improving quality of care for mothers and newborns (i) Evidence-based antenatal care in Mozambique – a cluster randomized controlled trial Antenatal care visits constitute one of the few times when women in many resource-poor settings seek care for their own health. Therefore they represent an important opportunity for reaching women with a number of interventions that may be vital for their health and the health of their unborn child. The Department is conducting a facility-based cluster randomized controlled trial (RCT) with a “stepped wedge” design in Mozambique, by developing an intervention targeted at increasing the delivery of evidence-based practices included in the ANC package by midwives, and promoting the integration of key interventions into routine ANC (3). The intervention includes: the provision of kits with all necessary medicines and laboratory supplies for ANC, a storage system, a tracking system, and training sessions for health-care providers. Progress On 2 June 2014, the Department, in collaboration with local partners and the Ministry of Health, successfully launched the intervention in the first facility. The ANC kits were well received by the health-care providers and pregnant women. Since then, the intervention has been rolled out in a new facility every two months as per the study design. As of December 2014, the intervention has been rolled out in four facilities, representing half of the selected facilities. The trial was featured in September on the homepage of the WHO website as an example of woman- centred health care and improved quality services. Planned activities • In 2015, the intervention will be rolled out at the remaining five selected facilities. • The Department plans to implement a nested secondary study to survey postpartum contraceptive use. (ii) Multicountry study to develop fetal growth standards Progress The Department is implementing a multicountry study to develop fetal growth standards for international application, by assessing fetal growth under nutritionally unrestricted conditions in populations of different ethnic and geographic backgrounds (4). The study had reached the expected sample size in the 10 participating countries by September 2014. Results of this study will have important clinical and research implications for the prenatal and postnatal periods, as well as for maternal health. Planned activities • The follow-up phase of the study will be finished by March 2015. • The main analysis, including the development of customized fetal growth curve tools, and several secondary analyses will take place in the second half of 2015. Annual Technical Report 201442 (iii) WHO Multicountry Survey on Maternal and Newborn Health The WHO Multicountry Survey (MCS) on Maternal and Newborn Health was a cross-sectional, facility-based survey conducted from May 2010 to December 2011. The survey aimed to assess the management of severe maternal complications and the prevalence of maternal near-miss cases. It captured information on over 314 000 women in 359 facilities across 29 countries in five WHO regions (5). The MCS has been a landmark study for several reasons. Firstly, it is the largest study of its kind to show that high coverage of effective evidence-based interventions in health-care facilities do not ensure good outcomes. This finding puts the emphasis on improving the quality of care by ensuring that care is not only effective but also delivered in a timely and efficient way, ensuring that it is safe, equitable and people- centred. The MCS firmly established a large research network that can conduct similar studies and also use the Department’s research for research capacity strengthening. Progress Following the publication of the primary findings in The Lancet in May 2013 (5), a series of 13 secondary analyses of the MCS dataset were published in a Special Issue on Maternal and Perinatal Morbidity and Mortality: Findings from the WHO Multicountry Survey in the BJOG: An International Journal of Obstetrics and Gynaecology in March 2014 (6). These analyses explored a range of critical topics, including: postpartum haemorrhage, pre-eclampsia and eclampsia, abortion, indirect causes of maternal death, adolescent pregnancy, advanced maternal age, maternal education, infection and caesarean section, intrapartum-related perinatal mortality, twin pregnancy, preterm birth and neonatal near-miss cases. A further three WHO MCS secondary analyses have been published in other journals, including an analysis of the use of antenatal corticosteroids and tocolytic drugs in preterm births in The Lancet (7), factors associated with corticosteroid use in China in the International Journal of Obstetrics and Gynaecology (8), and risk factors and adverse outcomes of small-for-gestational-age infants in PLOS ONE (9). The study investigating the burden and causes of life-threatening maternal complications and the quality of emergency obstetric care in 42 tertiary public hospitals in Nigeria has been completed and the results have been analysed and accepted for publication in the BJOG: An International Journal of Obstetrics and Gynaecology. This is a related study using the near-miss approach, which assessed the timeliness of the interventions. The findings did not point to a clear link between time to intervene and adverse outcomes. Planned activities • Several more WHO MCS secondary analyses are currently under review by journals or are ongoing. It is planned that these will be published as a journal supplement. (iv) Respect for women during pregnancy and facility-based childbirth: development and validation of measurement tools in three countries. Every woman has the right to dignified, respectful care during pregnancy and childbirth. Recent evidence has demonstrated that globally many women experience disrespectful or abusive treatment during labour and delivery in health-care facilities, which can pose a significant barrier to women presenting Thematic areas 43 to facilities for delivery (10). Disrespectful and abusive treatment during childbirth may also result in poorer health outcomes for women and newborns. Recent efforts to define and measure disrespect and abuse have resulted in highly variable estimates of prevalence. Despite the growing recognition of this important public health problem (11), no effort has been made at the global level to define and measure its prevalence. To achieve this, there is a clear need for consensus on a universal definition of disrespectful and abusive treatment during childbirth in facilities, in order to develop and validate tools to measure disrespect and abuse globally. The primary objectives of this study are: • to develop an evidence-based definition and criteria for identification of disrespect and abuse during childbirth in facilities that can be used globally; • to develop and validate tools for measuring disrespect and abuse during childbirth in facilities in three countries; and • to explore individual, provider, institutional and health systems factors that either promote or prevent disrespectful and abusive practices during childbirth in facilities. Progress A two-phased, mixed methods study design is being used. Phase 1 is a formative phase that will use qualitative research methods (focus group discussions and in-depth interviews) and systematic reviews to develop an evidence-based definition, identification criteria and two tools for measuring disrespect and abuse in facilities: (a) an observation tool using direct observation during childbirth at facilities and (b) a community-based survey tool using women’s self-reports 4–6 weeks postpartum. Phase 1 findings will also improve understanding of the individual-, provider- and facility-level factors that could contribute to disrespect and abuse. In phase 2, these two new tools will be applied using quantitative and qualitative research methods in three countries. The two tools will be analysed and compared using quantitative research methods. The observational tool will be used as a reference standard against which the community survey tool will be validated. Three facilities per country will be used for the observational component, with community follow-up of enrolled women 4–6 weeks postpartum. Planned activities • Phase 1 will commence data collection in February 2015. • Phase 2 will be implemented in 2016–2017. (v) Facilitators and barriers to facility-based delivery in low- and middle- income countries Progress As part of the Maternal and Perinatal Health and Preventing Unsafe Abortion team’s work on promoting quality of intrapartum care, a systematic review of qualitative evidence related to the facilitators and barriers to women delivering at health-care facilities in low- and middle-income countries was conducted and subsequently published. The review identified multiple barriers to women accessing facility-based delivery, including: traditional and familial influences; Annual Technical Report 201444 distance to the facility; direct and indirect costs of childbirth; low perceived quality of care; and fear of discrimination and mistreatment by health-care providers (10). Strategies and incentives to promote and sustain respectful, non-abusive, high quality care during facility-based childbirth are required to build trust between women and providers and promote institutional delivery. Between September and November this article was viewed online more than 4500 times. Planned activities • A systematic review of qualitative research on respectful maternal care (as an additional component of formative work on disrespect and abuse during facility-based delivery) is planned. (vi) Research and development of innovative tools for better outcomes in labour difficulty Complications arising during labour and childbirth account for a significant proportion of the global burden of maternal and newborn mortality and morbidity, particularly in low- and middle-income countries. Yet the quality of intrapartum care at many health-care facilities in low-resource settings remains suboptimal. The Department initiated the Better Outcomes in Labour Difficulty (BOLD) project to accelerate the reduction of intrapartum-related maternal, fetal and newborn mortality and morbidity by addressing the weaknesses in the process of labour care and bridging the disconnect between the health systems and the communities in low-resource settings. The project seeks to achieve this goal through a two-pronged approach: (a) develop a Simplified, Effective, Labour Monitoring-to-Action tool (SELMA) to assist health-care providers to monitor labour and take decisive actions more efficiently; and (b) develop innovative tools (termed “Passport to Safer Birth”) designed with community groups and health-care providers, to promote access to respectful, quality care for pregnant women at the time of delivery. It is envisioned that these tools will be integrated into a quality improvement approach, which will then be tested using intervention research. Progress The project kicked-off with a technical consultation (involving the Steering Committee and the Technical Advisory Group) in February 2014. Eight hospitals have been identified in Nigeria and Uganda for the initial data collection (cohort, qualitative and design research) that will inform the development of the tools. The final study protocols (with the conceptual framework) have been approved by the WHO Research Project Review Panel (RP2), the WHO Ethics Review Committee, and the Institutional Review Boards of all participating hospitals. Research training workshops have been conducted in both countries and data collection for the formative and clinical cohort started in both countries on 1 December 2014. The second technical consultation took place in November 2014. Planned activities • Data collection for both the cohort and qualitative/design research is expected to be completed by June 2015. • Analysis of study results and development of prototypes of the tools are expected to be completed by the end of 2015. Thematic areas 45 • The protocol manuscripts have been submitted for publication and should be published by the second quarter of 2015. (vii) The Gentle Assisted Pushing Study: a multicentre randomized controlled trial of gentle assisted pushing (GAP) in the upright posture to reduce prolonged second stage of labour A prolonged second stage of labour is hazardous for the baby. To expedite delivery, fundal pressure is frequently applied, although there is very little objective evidence of the effectiveness or safety of this action. The recumbent/supine posture for the second stage of labour has become routine in health services in low-resource settings. There is some evidence that upright postures may have advantages for mother and baby, but more evidence is needed. Progress The objective of this RCT is to compare the use of (a) a gentle method of applying fundal pressure in an upright posture, (b) upright posture alone, and (c) routine practice to reducing the time of delivery and the associated maternal and neonatal complications in women who have not delivered within 15–30 minutes in the second stage of labour. A total of 1145 participants will be recruited in four sites in South Africa over an 18-month period. Healthy nulliparous women with uncomplicated, singleton, cephalic pregnancies, anticipating vaginal delivery, will be asked to participate. The primary outcome is mean time from randomization to delivery. Recruitment commenced in December 2014. Planned activities • Recruitment will continue throughout 2015 and be completed in mid-2016. (viii) The Odón device The objective of this study is to evaluate the safety and feasibility of using the Odón device to assist with vaginal delivery in singleton, term pregnancies during the second stage of labour under normal conditions (12). This study is a hospital- based, multicentre, prospective, phase I cohort study with no control group. Progress The phase I study continued recruitment in Argentina during 2014, with 45 women included by end of December. In 2014, a further development right for the Odón Device was obtained by Becton Dickinson; the company is in the process of developing a new prototype which will be used in the remainder of phase I participants. Planned activities • In 2015, phase I will be expanded to several other research sites. • Recruitment of the planned sample size of 130 women will be completed in 2015. 3.3.2.2 Hypertensive disorders of pregnancy (i) Screening for pre-eclampsia – evaluation of the predictive ability of angiogenic factors Dysregulated angiogenesis during the preclinical phase of pre-eclampsia may provide an opportunity for early prediction through the measurement of serum and urinary predictive biomarkers in the first half of pregnancy. From 2006 to 2009, Annual Technical Report 201446 5121 pregnant women with risk factors for pre-eclampsia (nulliparity, diabetes, previous pre-eclampsia, chronic hypertension) from Argentina, Colombia, India, Italy, Kenya, Peru, Switzerland and Thailand had their serum tested for sFlt-1, PlGF and sEng levels and their urine for PlGF levels at < 20 weeks’ gestation (index tests, results blinded from carers), and again at 23–27 weeks and at 32–35 weeks. Progress Data from the 5121 pregnant women have been analysed. Results show that measurement of these factors, early in pregnancy, is not predictive. The manuscript has been submitted for publication. Planned activities • The results of the study will be published in 2015 and secondary analyses are planned to look into the markers for stillbirth and preterm birth. (ii) Long-term calcium supplementation in women at high risk of pre- eclampsia – a multicountry, double-blind, randomized controlled trial Calcium supplementation has been shown to reduce the severity of pre-eclampsia, and to reduce maternal morbidity and newborn mortality when supplementation starts at around mid-pregnancy, particularly in women with low calcium intake. A calcium dose of 500 mg (elemental) is included in the Essential Medicines List by the 19th Expert Committee on the Selection and Use of Essential Medicines (13), and current WHO guidelines issued in 2014 recommend 1.5–2.0 g daily elemental calcium supplementation in pregnant women from 20 weeks’ gestation until the end of the pregnancy. However, calcium supplementation in the second half of pregnancy may be too late to affect pre-eclamptic processes, and it has been proposed that further improvements in outcomes may be achieved by earlier supplementation. Consequently, the Department engaged in 2011 in a multicountry, double blind, placebo-controlled RCT to assess if calcium supplementation before and in the first half of pregnancy reduces the incidence of recurrent pre-eclampsia more effectively than supplementation starting at 20 weeks. If found effective, the groundwork will have been done for further research and then implementation of food fortification programmes. Progress The trial started in 2011 and, as of October 2014, 1798 women had been screened; 872 had been recruited and 284 pregnancies in sites in Argentina, South Africa and Zimbabwe were recorded. The sample size to be achieved is 1440 women. Planned activities • Recruitment will continue during 2015, and it is expected that it will be completed early in 2016. (iii) Simplified Treatment for Eclampsia Prevention using Magnesium Sulfate (STEPMAG) trial Magnesium sulfate (MgSO4) is the drug of choice for treatment of women with pre-eclampsia and eclampsia. There is clear evidence that it reduces the risk of eclampsia by close to 50% and probably reduces the risk of death in women with pre-eclampsia. Administration of the currently recommended dosage regimens requires resources that are often not universally available in low-income settings Thematic areas 47 where severe morbidity and death relating to pre-eclampsia are most common. As part of WHO efforts to increase coverage of magnesium sulfate use as prophylaxis and treatment for eclampsia worldwide, a technical consultation was held in collaboration with Merck for Mothers in October 2013, to deliberate on how to generate an evidence base for an alternative, easier to use, but equally efficacious magnesium sulfate regimen. At this meeting, international research partners identified a clear need for a stepwise approach to establish the rationale and scientific basis for testing a simpler magnesium sulfate regimen. Progress and planned activities The Department has embarked on a number of converging activities to justify the need for and the choice of minimum dosage of magnesium sulfate in preparation for a large-scale non-inferiority trial. (a) STEPMAG preparatory systematic reviews As part of the STEPMAG trial preparatory activities, we have completed two systematic reviews: a systematic review of non-randomized studies on the use of alternative regimens of magnesium sulfate for treatment of pre-eclampsia and eclampsia; and a systematic review of clinical pharmacokinetic properties of magnesium sulfate in women with pre-eclampsia and eclampsia. An update of the Cochrane systematic review on alternative regimens of magnesium sulfate for prevention and treatment of pre-eclampsia and eclampsia is ongoing. All three systematic reviews will be published in 2015. (b) Magnesium sulfate dose finding study In order to improve the probability of success for the proposed WHO non-inferiority trial, a modelling and simulation approach is being explored to find a minimum effective and simplified dosage regimen. The goal of such a model-based approach is to systematically assess various dosing regimens to identify one that will achieve both equivalent (non-inferior) efficacy while being more practical to implement. Modelling and simulation provides a powerful tool to assess whether one or more selected dosing regimens will meet pre-specified non-inferiority margins for such a large-scale trial. The Department is exploring this methodology (through a pharmacokinetic–pharmacodynamic study) in collaboration with experts at Merck in the USA. The modelling team at Merck is currently exploring a stepwise use of three existing data sets of serum magnesium levels and health outcome data in women receiving magnesium sulfate for pre-eclampsia, eclampsia and fetal neuroprotection, to perform the modelling and simulation. The protocol and modelling action plan was finalized in October 2014 and is undergoing review by the STEPMAG technical working group. Approvals and legal documents are currently being finalized with three institutions for Merck to be able to receive and use existing datasets for the modelling work. The study protocol will be published in the first quarter of 2015. Depending on the availability of the three data sets, it is expected that the modelling work will be concluded before the last quarter of 2015. (c) Global Clinical Practice Patterns in the Use of Magnesium Sulfate for the Prevention and Treatment of Eclampsia – a multicountry survey Although there are two recommended magnesium sulfate dosing regimens that are widely accepted, there has not been sufficient research to determine Annual Technical Report 201448 the optimal magnesium sulfate regimen for women with severe pre-eclampsia or eclampsia. Additionally, there are significant barriers to accessing and using magnesium sulfate in health-care facilities. There is also some evidence of variability in the use of magnesium sulfate for the prevention and treatment of eclampsia in facilities around the world, and use of regimens other than those recommended by WHO have been described. In the context of this uncertainty around the optimal magnesium sulfate regimen and the multiple barriers to its access and use, WHO will be conducting a survey to characterize current clinical practices in the prevention and management of severe pre-eclampsia and eclampsia in a global network of health-care facilities. This will be a two-part, cross-sectional, self-administered survey of facility administrators and individual health-care providers within institutions of the WHO Multi-Country Survey Network. The protocol has been finalized and is awaiting approval by the RP2. The survey will commence in early 2015. 3.3.2.3 Obstetric fistula Progress The report on the results of the RCT on short-term (seven-day) catheter stay following simple fistula repair was submitted to and accepted by The Lancet in 2014. The trial showed that seven-day bladder catheterization after repair of simple fistula was non-inferior to 14-day catheterization. It is safe and effective for managing women following repair of simple fistula with no evidence of a significant increased risk of repair breakdown, urinary retention or residual incontinence through three months after surgery. The trial dataset is currently being further examined using cluster analysis to develop a fistula classification system by patient and fistula characteristics within the collaboration with EngenderHealth on this project. Under this collaboration, WHO has become part of the International Research Advisory Group for the Fistula Care Plus project (2013–2018). The technical consultations resulted in priority research areas/questions, including measurement, and WHO will continue to collaborate with EngenderHealth under the Fistula Care Plus project. A manuscript on “Measuring the incidence and prevalence of obstetric fistula: approaches, needs and recommendations” has been published in the Bulletin of the World Health Organization in January 2015 (14). Planned activities • If the ongoing analysis on the classification system is successful, a technical consultation will be convened to reach consensus on fistula classification. 3.3.2.4 Postpartum haemorrhage (i) Carbetocin room temperature stable (RTS) for preventing postpartum haemorrhage – a randomized, non-inferiority, active controlled trial This is a hospital-based, multicentre, double-blind, randomized, non-inferiority, active controlled trial to evaluate if carbetocin RTS 100µg intramuscular (IM) is non-inferior to oxytocin 10 IU IM, as a uterotonic during the third stage of labour, for preventing postpartum haemorrhage in women delivering vaginally. Centres from 11 countries are expected to recruit 30 000 women over a period of 12 months. Should this trial demonstrate that carbetocin RTS is non-inferior to Thematic areas 49 oxytocin in preventing postpartum haemorrhage, in settings where the cold chain could not be guaranteed, oxytocin could be replaced by carbetocin RTS as the uterotonic used during the third stage of labour. The stability data from long-term studies performed at 30°C/75% relative humidity and accelerated at 40°C/75% relative humidity indicate that a shelf life of at least 24 months at 30°C is feasible for the new RTS formulation of carbetocin. Progress During 2014, the trial steering committee met, the protocol was finalized, an international contract research organization was engaged, and the selection of study sites was finalized. Planned activities The trial is scheduled to start in the first quarter of 2015. The initiation date at each participating centre will depend on when the protocol is approved at country level. Once the trial starts, monitoring visits will be organized to ensure compliance with the protocol and Good Clinical Practice. (ii) Non-pneumatic anti-shock garment The non-pneumatic anti-shock garment (NASG) is a simple device for improving survival in women experiencing obstetric haemorrhage-related hypovolemic shock. Progress In April 2014, a technical consultation was held in Geneva with research, donor and implementation partners to review the evidence on safety and effectiveness of the NASG and to identify research questions and next steps for the NASG research activities. Research priorities identified were: • interrupted time series study of ongoing, large-scale NASG implementation in comprehensive emergency obstetric care facilities; • pragmatic RCT of effectiveness of NASG in basic emergency obstetric care facilities (where NASG is primarily for first aid stabilization and referral), as well as economic analyses (cost-effectiveness, cost barriers) and qualitative research on barriers, enablers, feasibility, acceptability and other implementation considerations. Planned activities • Further implementation of the above-mentioned research will depend on the availability of dedicated funding. (iii) Stability of oxytocin along the supply chain The objective of this study is to evaluate how temperature variations during the supply chain and storage might affect the potency of the active ingredient of oxytocin products at health-care provider level. Several studies looked at the quality of oxytocin at the point of sale and found that in many places the active pharmaceutical ingredient was below the specifications. The possible causes identified were the poor quality of manufacturing and inappropriate conditions during transport or storage at the health-care facility, but no rigorous research has been done to confirm this. Annual Technical Report 201450 Progress This study will be implemented in Ghana and will be run in collaboration with the UN Commission for Life-Saving Commodities, Merck for Mothers, the WHO Essential Medicines and Health Products Department, and UNFPA. The protocol has been finished and partners have been contacted. Planned activities • With the completion of preparatory activities in 2014, the implementation in Ghana – and potentially one more African country – will take place in 2015. (iv) Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis Many different uterotonic drugs have been used for reducing the incidence of postpartum haemorrhage (PPH). These include oxytocin, misoprostol, ergometrine, carbetocin, and combinations of these drugs. Existing evidence presents conflicting results on relative effectiveness, making it difficult to draw firm inferences about all available drugs. Progress To close this gap, a systematic review and network meta-analysis of all uterotonic drugs for reducing the occurrence of PPH is currently being undertaken, with the aim of ranking their effectiveness and cost-effectiveness, and documenting their side-effect profiles. The protocol has been developed and registered as a Cochrane title, making this the first network analysis review by the Cochrane Pregnancy and Childbirth Review Group. The review is currently ongoing. Planned activities • The review will be completed by mid-2015. 3.3.2.5 Preterm birth (i) PREBIC/WHO Preterm Birth Epidemiology Working Group The Department has been collaborating with the Preterm Birth International Collaborative (PREBIC), which is a gathering of international researchers working in the area of preterm birth. Progress In 2014 two PREBIC meetings took place at WHO headquarters, one involving the whole PREBIC group, and another, later in the year, involving the epidemiology working group. A technical consultation was held in September 2014 with the Preterm Birth Epidemiology Working Group (EWG) to review current work and knowledge gaps related to levels and trends in preterm birth rates, including the several lines of preterm birth analysis occurring within this collaboration on the WHO Multicountry Survey of Maternal and Newborn Health, Euro-Peristat datasets, and several national datasets from high-income countries, including Canada, Denmark, Finland, Japan, Norway, Sweden and the United States. With the publication of the Antenatal Corticosteroid Trial (ACT) suggesting potential harm with expanding antenatal corticosteroid treatment to lower-level Thematic areas 51 health-care facilities (15), new research questions have also been identified for further discussion. In addition, while many trials have been conducted on tocolytic drugs, no trial has established whether tocolysis using nifedipine (the currently recommended first- line tocolytic drug) actually improves substantive perinatal outcomes. In 2014, the Department drafted a trial protocol to address the question of whether nifedipine plus antenatal corticosteroids (ACS) are better than ACS alone for preventing perinatal mortality and severe morbidity in women with threatened preterm labour at gestational age less than or equal to 34 weeks. Planned activities • In 2015, the Department will collaborate with groups active in preterm birth research such as March of Dimes, PREBIC and the University of California San Francisco, who have initiated a large preterm birth research programme. • The proposed trial comparing nifedipine plus ACS to ACS alone will be operationalized if specified funding is available. 3.3.2.6 Implementation research The Department’s Maternal and Perinatal Health team follows and monitors the implementation of several implementation research projects supported by the Implementation Research Platform (IRP). (i) Effectiveness and acceptability of using skilled birth attendance (SBA) services through community reproductive health nurses (CORNs) in rural communities of Ethiopia – a randomized controlled trial This project was one of the successful applicants to the WHO IRP competitive funding. This three-arm cluster RCT will evaluate the effectiveness and acceptability of using skilled birth attendance (SBA) services through CORN in rural communities in the Gedeo Zone, Ethiopia. Study participants will be all pregnant women in the selected communities who will give birth at home and at community health posts during the study period. In intervention clusters, CORNs will be trained and deployed to provide basic reproductive health care, particularly SBA, for births at home (Arm 1) and births at community health posts (Arm 2), with a control arm of randomly selected clusters (Arm 3). (ii) The effect of training community health providers and provision of mother-baby packs on early ANC attendance and health facility deliveries in rural Zambia This project was another successful applicant to the WHO IRP competitive funding. The objective of this study is to increase hospital deliveries and first trimester ANC attendance by pregnant women in Samfya district, Luapula province, Zambia. This is a quasi-experimental intervention and control study. The target population will be pregnant women and community health providers at the intervention sites. The intervention will involve: (a) training community health providers on issues related to ANC and the importance of facility-based deliveries; (b) providing mother-baby packs at the community level prior to delivery; and (c) orienting facility-based health-care providers on good ANC practices. The control site will have pregnant women receiving routine ANC as per national protocols. Annual Technical Report 201452 (iii) Assessing the impact of an intervention to improve the quality of emergency obstetric care (EOBC) on maternal and perinatal outcomes in Nigeria As part of the IRP, supported under the IRP initiative for leveraging funding, the team of researchers from the Women’s Health and Action Research Centre (WHARC) in collaboration with the Immpact Program at the University of Aberdeen and the RHR Department will implement a project entitled “Assessing the impact of an intervention to improve the quality of emergency obstetric care (EOBC) on maternal and perinatal outcomes in Nigeria”. This project is a multicentre, quasi-experimental study that aims to assess the impact of a package of interventions when used in secondary and tertiary level health-care facilities in Nigeria. It will be conducted in three phases over a three- year period in four intervention hospitals, with four hospitals of similar status acting as control sites. The results will enable the identification of a system-wide quality-of-care framework for improving the delivery of EOBC for the prevention of maternal and perinatal morbidity and mortality in Nigeria. (iv) 2011 Implementation Research Platform call for proposals As a partner in the IRP call for proposals, the Department is managing the following three studies from IRP’s first call for proposals. • “Assessing the acceptability, feasibility and effectiveness of a strategy for improving the quality and safety of maternal/neonatal health care in the health service contexts of four Middle Eastern countries.” This study will be completed in 2015. • “Innovations for increasing access to integrated safe delivery, prevention of mother-to-child transmission (PMTCT) and newborn care in rural Uganda.” This study will be completed in 2015. • “A matched pair cluster-randomized implementation study to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous populations in Guatemala.” This study obtained a further Grand Challenges scale-up grant in 2014. (v) A comprehensive strategy for building capacity for implementation research in low- and middle-income countries A number of knowledge gaps have been identified by the IRP partners (the RHR Department/HRP, the Special Programme for Research and Training in Tropical Diseases, and the Alliance for Health Policy and Systems Research) over the past several years, including a need for effective strategies to build capacity for implementation research. With the calls for implementation research launched by IRP and by individual IRP partners, it is clear that while there is a growing interest in the field of implementation research, the capacity to propose and undertake well designed implementation research studies is still very limited, especially in low- and middle-income countries (LMICs), by LMIC researchers and implementers. Currently a proposal is being developed to promote implementation research in LMICs, to ensure a high level of competency on implementation research at the regional and country levels, and to create synergies and collaborations between programme implementers, individual researchers, and research/public health institutions. Planned activities • After selection of the institutions, capacity strengthening workshops and training programmes will be implemented in 2015. Thematic areas 53 3.3.3 Norms, standards and tools 3.3.3.1 Improving quality of care for mothers and newborns (i) Antenatal care guidelines ANC is an important part of the continuum of care for improving outcomes for mothers and their babies by providing a platform for health promotion, disease prevention, early detection and treatment of complications, birth preparedness and complication readiness. Most recent WHO guidance (2002) was based on the results of a trial that evaluated the effectiveness of a package of reduced visits with evidence-based interventions through goal-oriented clinic visits, known as focused antenatal care (FANC) approach (16). Progress As part of the Department’s efforts to consolidate evidence-based guidance on the provision of quality care during this period, recommendations for the interventions needed during the ANC period, as well as how these interventions should be delivered, are currently being developed (2014–2016). The first working group and technical consultation took place on 22–25 April 2014. Priority questions and outcomes for the recommendations were finalized in October 2014. The Department is collaborating with other WHO Departments including the Department of Maternal, Newborn, Child and Adolescent Health, the Department of Nutrition for Health and Development, and the Department of Immunization, Vaccines and Biologicals, as well as other UN partners, and initiatives like Roll Back Malaria. The focus of the guideline is the essential core package of ANC that all women should receive. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) framework will be used to assess the evidence and the work is being developed under the following work streams: individual interventions, antenatal testing, barriers and facilitators to access to and provision of care, large-scale programme evaluation, health system and community level interventions, and modelling. In preparation for this guideline, 56 Cochrane systematic reviews have been identified for updating. The updates of these reviews are in progress; four have been completed. The grading of evidence from all systematic reviews and preparation of draft narrative summaries are ongoing. Two papers that synthesise the qualitative evidence on barriers and facilitators are also being prepared. Annual Technical Report 201454 Figure 3.3.1: Antenatal care interventions and the synthesis of evidence – GRADE and DECIDE are the frameworks for assessing the quality of evidence Planned activities • The recommendations will be finalized and published by the beginning of 2016 together with the publication of the Cochrane systematic review updates and other related systematic reviews. • The Guideline Development Group will explore the use of online tools for communications, including for targeting different guideline components for different audiences. Modelling will be explored as an interactive decision- making tool for policy-makers. (ii) Intrapartum care and obstructed labour (a) WHO recommendations for augmentation of labour Prolonged labour is an important cause of perinatal and maternal morbidity and mortality. Labour augmentation with oxytocin has commonly been used to treat slow labour resulting from weak or inefficient uterine contractions. Despite the benefits, the inappropriate use of labour augmentation can cause harm to the mother and her baby. Progress The primary objective of the WHO recommendations for augmentation of labour is to consolidate the guidance for effective interventions that are needed to reduce the global burden of prolonged labour and its consequences. In May 2014, the Thematic areas 55 new WHO guideline containing a total of 20 recommendations relating to the practice of labour augmentation was published on the Department’s website and disseminated through the Department’s network of partners, including hard copies (17). Planned activities • Evidence briefs are currently being developed and will be available by the first quarter of 2015. (b) Optimal caesarean section rate The proportion of deliveries by caesarean section at the population level is a measure of access to and use of an obstetric intervention for averting maternal and neonatal mortality and morbidity. It is useful as a reference for policy-makers and governments when assessing national and regional health indicators on maternal and infant health and use of resources. Monitoring global, regional and country estimates of caesarean section is important to assist countries to track levels of this life-saving health intervention to identify gaps, support decisions and inform ongoing efforts towards improving maternal and newborn health. Despite WHO’s recommendation in 1985 stating that “there is no justification for any region to have a caesarean section rate higher than 10–15%”, rates worldwide have increased steadily in an unprecedented manner in both developed and developing countries. There is international concern about the validity of this benchmark in light of three more decades of accumulated evidence and improvements in both clinical obstetric care and methodologies to assess evidence and issue recommendations. Progress In 2014, the Department convened a technical consultation to review and update the 1985 statement. In preparation, the following reviews were undertaken: • update of the 2007 caesarean section global estimates; • trend analysis of the changes between countries and regions over the last few decades; • systematic review of ecologic studies; • worldwide analysis of the association between caesarean section and maternal and neonatal mortality. The technical consultation was held in Geneva, on 18–19 October 2014. On the basis of the discussions and evidence presented, the group concluded that caesarean section rates higher than 10% do not necessarily contribute to reducing maternal and newborn mortality rates. In countries with low caesarean section rates, socioeconomic development rather than caesarean section rates is probably a more important factor in influencing mortality outcomes. Planned activities • Acknowledging that mortality outcomes are not the only important indicators, the Department will work with countries with reliable health information systems to conduct analyses at national or subnational levels to appropriately assess the association between caesarean section rates and morbidity indicators. The Department will explore research on assessing the psychosocial implications Annual Technical Report 201456 of caesarean section regarding the maternal–infant relationship, women’s psychological health, and women’s ability to successfully initiate breastfeeding. (c) Monitoring of caesarean section practices The lack of a standardized, internationally accepted classification system to monitor and compare caesarean section rates in a consistent and action-oriented manner is one of the factors preventing a better understanding of changes in caesarean section rates and the underlying causes. The Department published a systematic review in 2011 which concluded that the Robson 10-group classification would be in the best position to fulfil current international and local needs (18). In 2013 a systematic review to assess the experiences, opinions and challenges encountered by users of this classification, the pros and cons of the adoption, implementation and interpretation of the Robson classification, as well as the adaptation, modifications and recommendations proposed for its use was conducted and published (19). Progress These two reviews were the basis for the second discussion at the technical consultation in Geneva in October 2014, with the objective of endorsing a classification system that can be universally adopted and can overcome many of the barriers and limitations that have plagued the clinical and scientific community for the last three decades. The Group agreed to adopt the Robson Classification for this purpose. It is expected that the use of this classification would assist health- care facilities to optimize the use of caesarean section, assess the quality of care and clinical management practices and outcomes by group, and potentially also to assess the effectiveness of implemented strategies or interventions targeted at optimizing the use of caesarean section. Another important aspect of caesarean section monitoring is to assess whether a particular health-care facility’s caesarean section rate is optimal or there are unnecessary caesarean sections according to its case mix. In a large international collaborative effort, the Department and its partners developed the C-Model, a global generic reference to determine the optimal caesarean section rate at the facility level according to specific characteristics of women attending the facility. The C-Model is designed to guide obstetric teams, health managers and other stakeholders in the complex task of optimizing caesarean section rates by providing a locally relevant reference. In order to facilitate use, an electronic calculator is available online to generate these estimates. 6 Planned activities • In 2015, guidelines for the implementation, interpretation and reporting of the Robson Classification will be developed. • The above-mentioned systematic reviews identified some issues that need to be addressed in order to standardize the classification: – establishing unambiguous definitions for spontaneous onset of labour, induction and augmentation; and – minimal gestational age to apply the classification. 6 Available at: http://200.144.255.68:8098/cmodel/ Thematic areas 57 • Other critical issues to be examined during the development of the guidelines include: how to use indications within each group of the classification; and definition of optimal caesarean section rates for each group using an outcome- based approach. • The C-Model will be pilot-tested and its robustness tested with interested partners and facilities. (d) Social determinants of caesarean section The contributing factors and determinants of the use or overuse of caesarean section are multiple and in many cases they are country- or context-specific. Social determinants are very important because women are more involved than in the past in the decision-making process for delivery. In addition, women are exposed and have access to a wide range of information on pregnancy and childbirth. Women’s magazines and the internet are two of the most ubiquitous sources of information that can play a critical role in shaping women’s opinions and influencing their decisions. However, the quality – including accuracy and completeness – of information available on the web is widely variable due to lack of governance or editorial control. Progress In 2014, the Department published the results of two reviews. The first assessed the quality and completeness of the information on caesarean section published in Spanish women’s magazines (20) while the second review assessed information on the internet used by lay persons in Brazil, a country with the highest rate of caesarean section (21). The authors of both reviews concluded that the quality and completeness of the information is not sufficient to help the reader understand the real benefits and risks of each mode of delivery. (e) Interventions to reduce unnecessary caesarean sections Progress In view of the increasing priority being given to this issue in the clinical and research contexts in the last few years, in 2014 the Department engaged in updating the Cochrane systematic review published in 2011 which evaluated the effectiveness and safety of non-clinical interventions for reducing unnecessary caesarean sections. The Cochrane review update was limited to RCTs, quasi- experimental studies, controlled clinical trials, controlled “before and after” studies with at least two intervention and control sites, and interrupted time series analyses. Observational studies, case reports or documentation of individual successful experiences are, for methodological reasons, not included. In order to complement the core findings of the Cochrane review, the Department is conducting a systematic review of these other methodological approaches plus innovative ideas on how to reduce unnecessary caesarean section. Even if these ideas provide no proof of effectiveness because they have not yet been tested according to current internationally accepted methodological standards, it is important to broaden the scope of the Cochrane review to get a more comprehensive understanding of all interventions proposed and implemented to optimize the rational use of caesarean section. This expanded review will help to pinpoint major determinants of unnecessary caesarean section as well as possible solutions for addressing escalating rates in many settings. Annual Technical Report 201458 Planned activities • The results of this updated review will be published in 2015. • A call for ideas for strategies aimed at reducing unnecessary caesarean section, to stimulate new thinking and to engage researchers from low-resource settings is also planned. • It is expected that this updated systematic review and the call for ideas will result in the identification of potential interventions that can be developed, shaped and tested in future research. 3.3.3.2 Management of maternal sepsis occurring around childbirth Maternal bacterial sepsis around the time of birth is among the leading causes of preventable maternal morbidity and mortality globally. Prompt identification and appropriate treatment of sepsis during the intrapartum and immediate postpartum periods are critical to reducing associated severe maternal as well as fetal and newborn complications. As part of the Department’s efforts to consolidate evidence-based guidance on the provision of quality care around the time of birth, recommendations on the prevention and management of intrapartum and postpartum maternal sepsis are currently being developed. Progress Priority questions and outcomes for the recommendations were finalized in June 2014. Out of the 21 Cochrane reviews identified for developing this guideline, 11 have been updated and published (or accepted for publication) between September and October 2014, five reviews are currently undergoing editorial processes while four of the reviews do not require updating (see details of these Cochrane reviews in Annex B). The grading of evidence from all systematic reviews and preparation of draft narrative summaries are ongoing. Planned activities • The recommendations will be finalized and published in 2015 together with the publication of the remaining Cochrane systematic review updates. • Evidence briefs will be developed and published in the second half of 2015. 3.3.3.3 Preterm birth Preterm birth is the leading cause of death and severe, acute and long-term disabilities for the neonate. Evidence-based guidance on the effectiveness and safety of interventions to prevent preterm birth, as well as supportive health- system characteristics, is crucial to improving outcomes for mothers and babies. The RHR Department and the Maternal, Newborn, Child and Adolescent Health (MCA) Department are collaborating to develop a set of guidelines that address questions relating to the effectiveness and safety of interventions for managing women at imminent risk of preterm birth, as well as care for the preterm newborn infants. A group of international stakeholders prioritized key questions and outcomes relating to this guideline during a technical consultation in April 2013. Progress In 2014, the Department collaborated with the Cochrane Pregnancy and Childbirth Group to update or conduct afresh 23 Cochrane reviews, and with the National Center for Child Health and Development in Japan to conduct seven Thematic areas 59 new systematic reviews of non-randomized studies to inform recommendation questions relating to the management of the mother; and graded evidence according to the GRADE methodology. The technical consultation to agree on the final recommendations was held in May 2014 and recommendations covering antenatal corticosteroids, tocolytics, antibiotics and optimal mode of preterm delivery were formulated by the Guideline Development Group (GDG). The RHR and MCA Departments also hosted an electronic consultation among the GDG members in November 2014 to review implications of the recently published trial on antenatal corticosteroid use in developing country settings on the formulated recommendations (15). The final guideline document and evidence tables have been completed according to the WHO Guideline Review Committee guidelines Planned activities • The recommendations will be published in 2015. • Evidence briefs will be developed in collaboration with USAID and will be published along with the main guideline document. • A commentary on the WHO recommendations – to further promote their dissemination and implementation – will also be published by the second half of 2015. 3.3.3.4 Research synthesis and guideline development methods (i) Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE) collaboration The Department is a key partner in the DECIDE project. This collaborative project, funded by the European Commission’s Seventh Framework Programme, aims to develop and evaluate communication strategies to inform evidence-based decision- making. As part of DECIDE, the Department has co-developed a framework for communicating evidence to inform policy decisions about health systems. Progress • A two-day workshop for policy-makers from eight European countries on the application of the DECIDE evidence-to-recommendation frameworks for WHO guidelines in task shifting was held in Slovenia in August 2014. The Department contributes to the development of evidence-to-recommendations and recommendations-to-decisions frameworks, in collaboration with the Norwegian Knowledge Centre for the Health Services. This occurs particularly through the ongoing use of DECIDE frameworks in guideline development, such as the forthcoming WHO recommendations on task shifting in the provision of abortion services, and WHO recommendations on ANC. • Further evidence briefs derived from the 2012 OptimizeMNH guidance on health worker roles (22) have been developed, to support the dissemination and use of the guidance on task-shifting approaches in maternal and neonatal health by policy-makers (23, 24, 25). The Department is also contributing to the ongoing development of the interactive Evidence-to-Decision (iEtD) framework tool. We conducted a two-day workshop for WHO guideline developers in Geneva (October 2014) to use the DECIDE frameworks and test the iEtD tool. Annual Technical Report 201460 (ii) The Confidence in the Evidence from Reviews of Qualitative research (CERQual) tool • Qualitative research is especially valuable in exploring questions related to the acceptability and feasibility of an intervention, among other implementation considerations. Methods for systematically reviewing the results of multiple qualitative primary research studies are an emerging area of research within the health sciences. However, as with evidence of effectiveness, decision-makers need tools for assessing how much confidence they can place in findings from systematic reviews of qualitative evidence. The CERQual tool provides a transparent method for assessing the confidence level of evidence from reviews of qualitative research, and for indicating this confidence to end-users, such as guideline panels or decision-makers. CERQual uses a similar approach conceptually to other GRADE tools, but is intended for findings from systematic reviews of qualitative evidence. Progress • The development of CERQual is being taken forward through the CERQual subgroup of the GRADE Working Group, in close partnership with the RHR Department. A manuscript describing the tool entitled “Assessing how much confidence to place in the evidence from qualitative evidence syntheses: the CERQual approach” has been submitted for publication. Planned activities • The Department will continue working on further development of the CERQual tool in 2015. 3.3.4 Monitoring and evaluation 3.4.4.1 Maternal mortality (i) Maternal mortality estimates The Department leads the collaborative effort with UNICEF, UNFPA, the World Bank and the United Nations Population Division to provide up-to-date estimates of global maternal mortality levels as part of monitoring progress towards Millennium Development Goal (MDG) 5 Target 5A (reducing, between 1990 and 2015, the maternal mortality ratio by 75%). This collaboration is known as the Maternal Mortality Estimation Interagency Group (MMEIG) and it is advised by an external Technical Advisory Group (TAG). Critical to the maternal mortality estimation process is a country consultation with Member States to review draft estimates prior to publication. The Department leads this effort and it has served as a starting point to engage countries in improving the quality of data collection. This consultation process has been recognized as transparent and a good example of how “WHO estimates” should be undertaken. Progress In May 2014, the MMEIG published estimates of maternal mortality with trends from 1990 to 2013; the number of women dying due to complications during pregnancy and childbirth has decreased by 45% from an estimated 523 000 in 1990 to 289 000 in 2013 (26). With the addition of new data points and increased country engagement, it is now evident that the statistical model used to estimate maternal mortality requires additional refinement to better reflect good quality country-level data. Thematic areas 61 The process to refine the statistical model and improve the estimation process for the last round of MDG reporting was initiated in mid-2014. A MMEIG and TAG meeting was convened in October 2014 to discuss potential changes to the model and to plan for country consultation for estimates related to the 1990–2015 reporting period. These estimates will be used for the final MDG report. Planned activities • In 2015, the MMEIG will complete the country consultation and publish a report on maternal mortality estimation with trends for 1990–2015. • The Department will support and participate in regional workshops related to improving measurement of maternal mortality in both the Eastern Mediterranean and Western Pacific Regions. • In collaboration with the MMEIG, TAG, and the Health Statistics and Informatics Department of WHO, the Department will lead the technical development of a robust statistical model which will expand these estimates to incorporate both estimates of total numbers of maternal deaths as well as estimates of individual causes of maternal death. • In collaboration with the MMEIG, TAG, and the Health Statistics and Informatics Department of WHO, the Department will elaborate specific country-level targets for the new Sustainable Development Goals (SDGs), using as a baseline figure the 2010 estimate for maternal mortality from the 1990–2015 estimation. (ii) Causes of maternal death Data on the causes of maternal deaths are needed to inform policies to improve maternal health. Progress WHO developed and analysed global, regional and subregional estimates of the causes of maternal death during 2003–2009 using a novel method, updating the previous WHO systematic review (27). The new analysis and estimates were published in Lancet Global Health (28). The literature search for this analysis included specialized and general bibliographic databases for research articles and data published between 1 January 2003 and 31 December 2012, with no language restrictions, as well as the WHO mortality database for vital registration data. Estimates of causes of death by MDG regions and worldwide, for main and sub-causes of death categories with a Bayesian hierarchical model, were reported. Overall, 417 datasets from 115 countries and including 60 799 maternal deaths were included in the analysis. Based on this analysis, 73% of all maternal deaths between 2003 and 2009 (i.e. 1 771 000 of 2 443 000) were estimated to be due to direct obstetric causes, while indirect causes accounted for 27.5%, haemorrhage for 27.1%, hypertensive disorders for 14.0% and sepsis for 10.7% of maternal deaths. The rest of these deaths were due to abortion (7.9%), embolism (3.2%) and all other direct causes of death (9.6%). Regional estimates varied substantially. These analyses will inform the prioritization of health policies, programmes and funding, to reduce maternal deaths at regional and global levels. Further efforts are needed to improve the availability and quality of data related to maternal mortality. Annual Technical Report 201462 Planned activities • The cause of maternal deaths will be analysed in categories specifically looking at the distribution of indirect causes of maternal deaths. 3.3.4.2 Maternal morbidity (i) Maternal morbidity working group With reductions in maternal mortality, increased emphasis is being placed on maternal morbidity, although a common definition of what constitutes maternal morbidity does not exist. Accurate and routine measurement of maternal morbidity is needed to inform policy and programme decisions and resource allocations. The Department received a grant from the Bill & Melinda Gates Foundation for a project that aims to address this challenge and to improve the scientific basis for defining, estimating and monitoring the magnitude of maternal morbidity. A Maternal Morbidity Working Group (MMWG) has been established, with representation from all WHO regions, relevant technical expertise in quantitative and qualitative measurement of maternal morbidities, and patient advocacy. Progress In 2014, the MMWG continued to refine the maternal morbidity framework to develop the basis for a community-based tool for measurement of morbidity. A stakeholders meeting was convened to share the progress of the MMWG and to receive their feedback and recommendations on the direction and scope of the work. The group reaffirmed the working definition and framework upon which a “tool” to measure maternal morbidity has been developed. The tool has undergone pre-testing in one country setting (Jamaica) and plans for pilot-testing in three countries are being finalized. A paper describing the methods and process of the MMWG was submitted for publication in a peer-reviewed journal and is under review. Planned activities • Pilot-testing of the tool will be completed in three country settings in 2015. • Systematic reviews describing the magnitude of maternal morbidity related to psychiatric conditions and noncommunicable diseases, such as cardiovascular disease, and the impact of maternal morbidity on maternal function will be published. • Indicators related to maternal morbidity will be developed (ii) Maternal near-miss cases Since its publication, the WHO maternal near-miss criteria and the audit tool have been applied in over 30 countries. Progress In collaboration with the Department, a number of countries, such as Brazil and Nigeria, have recently conducted national-level surveillance studies, and there are many other countries that would like to implement the near-miss tool at scale. Planned activities • The systematic review on maternal near-miss has been updated and is being prepared for submission to a peer-reviewed journal in 2015. Thematic areas 63 • Learning from the research and field experiences, the Department is planning a technical consultation entitled “WHO maternal near-miss approach and quality of care: research and Implementation” in January 2015, to examine the evidence on the current application of this tool and to identify ways to implement the near-miss approach at scale while establishing links between communities and facilities. 3.3.4.3 Perinatal mortality The large number of perinatal death classifications in the literature suggests that none of them is accepted as a uniform system which can be applied in different environments. Recent efforts have focused on the development of a single, multi-layered system that can facilitate comparisons between and within diverse settings, including low-, middle- and high-income countries. This would allow benchmarking and the identification of trends, gaps and modifiable factors. In turn, this will help to focus local efforts on improving maternity care and developing strategies for prevention. Especially following the recent publication of the ICD-Maternal Mortality (ICD- MM), systematically classifying maternal deaths, there is an urgent need for a high- quality global classification system for causes of perinatal death. The place to start in constructing such a system is a review of what currently exists and how current systems match up with important criteria for such a system. Progress WHO has been working with a number of research partners undertaking a literature review to provide background papers to inform the development of this global classification system. This review will include a comprehensive search (including non-English articles) and will base data extraction upon key criteria for a global system agreed by an expert panel. WHO will use the outcomes of this review to inform the development of a globally accepted system. A technical consultation was convened (July 2014) on the WHO Application of ICD-10 to perinatal deaths: ICD-Perinatal Mortality (ICD-PM), modelled on the WHO Application of ICD-10 to deaths during pregnancy, childbirth and the puerperium: ICD-MM, on maternal mortality (29). The ICD-PM classification system has several unique features, necessary to optimize the classification of perinatal mortality across all settings. It identifies the time of death as the first step in classification (i.e. antepartum, intrapartum, early neonatal or late neonatal) and it is multi-layered such that the depth of classification can reflect the locally available information. The third important feature is the requirement that a maternal condition (healthy or otherwise) be documented for every perinatal death, such that the system reflects the inherently linked health outcomes of these two groups of patients. Planned activities • The ICD-PM draft document will be presented at the next ICD Genitourinary and Reproductive Medicine Technical Advisory Group meeting (date not yet known yet) in alignment with the ICD-11 revision process. The work on the document will continue incorporating feedback. • The manuscripts on Delphi survey and the systematic review will be published in 2015. Annual Technical Report 201464 3.3.5 Dissemination and partnerships 3.3.5.1 WHO statement on prevention and elimination of disrespect and abuse during facility-based childbirth Progress Following a technical consultation on disrespect and abuse experienced by women during facility-based childbirth in November 2013, the Department has initiated research activities on this important and under-researched area. To highlight the need for greater cooperation, research and action on this topic, in collaboration with international partners we developed and published the WHO statement on The prevention and elimination of disrespect and abuse during facility-based childbirth in September 2014 (11). The statement was launched at the UN General Assembly (New York, September 2014) and the Third Global Symposium on Health Systems Research (Cape Town, September 2014) and was widely disseminated to governments, health- care providers, managers, profess

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