Planning and Implementing Cervical Cancer Prevention and Control Programs
Publication date: 2004
Planning and Implementing Cervical Cancer Prevention and Control Programs EngenderHealth International Agency for Research on Cancer JHPIEGO Pan American Health Organization PATH A MANUAL FOR MANAGERS Endorsing Agencies World Health Organization Geneva AFRO International Network for Cancer Treatment and Research Planning and Implementing Cervical Cancer Prevention and Control Programs A MANUAL FOR MANAGERS Alliance for Cervical Cancer Prevention 2004 Support for the development of this publication was provided by the Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention. ii iii Copyright © 2004, EngenderHealth, International Agency for Research on Cancer (IARC), JHPIEGO, Pan American Health Organization (PAHO), Program for Appropriate Technology in Health (PATH). All rights reserved. e material in this document may be freely used for educational or noncommercial purposes, provided that the material is accompanied by an acknowledgement line. All photos are the property of ACCP partner organizations unless otherwise indicated. Suggested citation: Alliance for Cervical Cancer Prevention (ACCP). Planning and Implementing Cervical Cancer Prevention and Control Programs: A Manual for Managers. Seattle: ACCP; 2004. ii iii Contents Foreword .vii About the Alliance for Cervical Cancer Prevention.viii Acknowledgments.x About the Manual.xiii Exective Summary .xv Part One: Background Chapter 1: Rationale for Cervical Cancer Prevention Key Messages . 3 Introduction . 3 Burden of Disease . 3 Natural History of Cervical Cancer . 5 Methods of Cervical Cancer Prevention . 7 Justification for Cervical Cancer Screening . 12 Conclusion . 14 Further Reading. 14 Appendix 1.1. Characteristics of Screening Tests . 15 Chapter 2: Overview of Policy Considerations Key Messages . 19 Introduction . 19 The Decision to Develop a Cervical Cancer Prevention Program . 19 Strategic Approach Framework. 20 Policy Decisions Concerning Services . 23 Conclusion . 28 Further Reading. 28 Part Two: Planning and Managing a Program Chapter 3: Initiating the Planning Process Key Messages . 31 Introduction . 31 Components of the Program. 34 Engaging Stakeholders. 37 Conclusion . 39 Further Reading. 39 Appendix 3.1. Checklist for Planning and Implementing a Program . 40 iv v Chapter 4: Assessing Program Needs Key Messages . 43 Introduction . 43 What Needs to Be Assessed . 43 How to Conduct the Local Needs Assessment . 47 Conclusion . 51 Further Reading. 51 Appendix 4.1. Sample Questions to Assess the Use of Policies, Guidelines, and Norms . 52 Appendix 4.2. Sample Questions to Assess Program Management Issues. 53 Appendix 4.3. Sample Questions to Assess Health Services . 54 Appendix 4.4. Sample Questions to Assess Information and Education Activities . 56 Appendix 4.5. Sample Questions to Assess Community Perspectives . 57 Appendix 4.6. Sample Questions to Assess a Laboratory . 59 Appendix 4.7. Sample Questions to Assess Information Systems . 61 Chapter 5: Planning, Preparing, and Launching the Program Key Messages . 63 Introduction . 63 Role of the Management Team. 63 Cost Considerations . 64 The Program Action Plan . 65 The Program Budget. 69 Establishing Systems for Service Delivery . 73 Establishing Systems for Supervision, Monitoring, and Evaluation . 74 Launching the Program . 77 Conclusion . 77 Part Three: Implementing Key Aspects of a Program Chapter 6: Delivering Clinical Services and Strengthening Linkages Key Messages . 81 Introduction . 81 The Role of the Management Team . 82 Ensuring Availability of Services . 82 Ensuring Access to Cervical Cancer Prevention Services . 89 Establishing and Maintaining Linkages and Referral Systems. 98 Conclusion . 106 Further Reading. 106 Appendix 6.1. Equipment and Supplies. 107 iv v Appendix 6.2. Cryotherapy Refrigerant Tank Size and Number of Procedures . 115 Appendix 6.3. Checklist for Planning Outreach Clinical Services. 117 Appendix 6.4. Equipment Illustrations . 119 Chapter 7: Providing Information and Counseling to Address Community and Client Needs Key Messages . 127 Introduction . 127 The Role of the Management Team . 129 Developing a Plan to Reach Eligible Women . 129 Components of an Information and Education Plan. 130 Information and Education Strategies . 131 Involving Community Leaders . 132 Feedback Between Strategies and Outcomes . 132 Outreach: Community-Based Information and Education . 132 Developing Local Partnerships. 135 Facility-Based Information and Education . 136 Media-Based Information and Education . 137 Counseling. 138 Information and Education Materials. 143 Conclusion . 146 Further Reading. 146 Appendix 7.1. ACCP Education and Counseling Materials . 147 Appendix 7.2. Recommended Information and Education Materials for Cervical Cancer Prevention Services . 149 Chapter 8: Training: Ensuring Performance to Standard Key Messages . 151 Introduction . 151 The Role of the Management Team . 152 Planning for Training . 152 Developing a Training System for Cervical Cancer Prevention . 158 Transfer of Learning. 162 Ensuring Performance to Standard . 163 Conclusion . 164 Further Reading. 165 Appendix 8.1. List of Training Tools . 166 Appendix 8.2. Cervical Cancer Prevention: Key Training Topics and Rationale . 167 Appendix 8.3. Checklist for Preparing a Workshop/Training Course. 170 Appendix 8.4. Faculty and Trainer Development Pathway. 171 vi vii Chapter 9: Improving Program Performance Key Messages . 173 Introduction . 173 Program Improvement Process. 174 Establishing a Health Information System . 181 Types of Health Information Systems. 184 Cancer Registries . 192 Conclusion . 192 Further Reading. 192 Appendix 9.1. Sample Client Identification Card . 193 Appendices 9.2A–D. Sample Registers for Facility-Level Health Information System. 194 Appendices 9.3A–E. Sample Forms for Centralized Health Information System. 198 Appendix 9.4. Examples of Reports. 203 Part Four: Overview of Cervical Cancer Treatment and Palliative Care Chapter 10: Cancer Treatment and Palliative Care Key Messages . 211 Introduction . 211 The Role of the Management Team . 212 Background . 212 Strategies to Establish and Strengthen Cervical Cancer Treatment Services . 218 Palliative Care . 223 Conclusion . 232 Further Reading. 233 Appendix 10.1. Technical and Programmatic Aspects of Treatment Options for Cervical Cancer . 234 Appendix 10.2. Commonly Used Analgesics for Cancer Pain Relief . 237 Appendix 10.3. FIGO Staging Classification for Cervical Cancer . 238 Acronyms, Glossary, and References Acronyms. 240 Glossary. 241 References . 246 vi vii Foreword Cervical cancer, the second most common cancer among women worldwide, is an important public health issue. ere were more than 493,000 new cases diagnosed and 273,500 deaths from cervical cancer in 2000. Approximately 85% of these deaths occurred in developing countries, and in some parts of the world cervical cancer claims the lives of more women than pregnancy-related causes. is condi- tion affects not only the health and lives of women, but also their children, families, and their community. is extended impact is oen undervalued when setting health priorities and requires greater consideration by policymakers. We have the tools to act. Cervical cancer is one of the most preventable and treat- able cancers, since it takes many years to develop from detectable precursor lesions. We have evidence-based interventions for effective early detection and treatment. is knowledge has been used in many developed countries by well-organized programs over the past 50 years. ese efforts have resulted in a remarkable reduc- tion in mortality and morbidity from cervical cancer. Over the same period, however, we have seen little or no change in developing countries. Some of the main barriers here are the lack of awareness among stake- holders, lack of cervical cancer control programs and absence of country-tailored guidelines for best practice of cervical cancer prevention and control. e World Health Organization (WHO) welcomes this initiative from the Alliance for Cervical Cancer Prevention (ACCP) to provide a manual for program managers at regional and local levels in developing countries. It draws upon their collective experience from implementing research and demonstration projects using new approaches to screening and treatment, and it does so in a variety of geographic and sociocultural settings and for a range of resource levels. is general, how-to manual responds to the fundamental challenge of moving from policy to actually organizing, implementing, and monitoring newly devel- oped programmes or strengthening existing cervical cancer prevention and control programs. It complements WHO’s managerial guidelines for National Cancer Control Programs, and WHO publications on Cervical Cancer Screening in Developing Countries, the International Agency for Research on Cancer (IARC)/ WHO Handbooks of Cancer Prevention, Volume 10: Cervix Cancer Screening, and the upcoming WHO Comprehensive Cervical Cancer Control: A Guide for Essential Practice for health care providers. e ACCP manual is part of a comprehensive resource package based on current evidence and encompassing policy, clinical practice, and service delivery. e package is an ideal toolset for WHO Member States to help increase the effective- ness of their efforts in their fight against cervical cancer. Catherine LeGales Camus Assistant to the Director General Noncommunicable Diseases and Mental Health Joy Phumaphi Assistant to the Director General Family and Community Health viii ix About the Alliance for Cervical Cancer Prevention e Alliance for Cervical Cancer Prevention (ACCP) consists of five international health organizations—EngenderHealth, the International Agency for Research on Cancer (IARC), JHPIEGO, the Pan American Health Organization (PAHO), and PATH—with the shared goal of preventing cervical cancer in developing coun- tries. Alliance partners work to identify, promote, and implement cervical cancer prevention strategies in low-resource settings, where cervical cancer prevalence and mortality are highest. For more information on the ACCP’s work and publi- cations, please visit www.alliance-cxca.org. ACCP partner organizations EngenderHealth 440 Ninth Avenue New York, NY 10001, USA Tel: 212-561-8000 Fax: 212-561-8067 Email: info@engenderhealth.org www.engenderhealth.org EngenderHealth works worldwide to improve the lives of individuals by making reproductive health services safe, available, and sustainable. ey provide technical assistance, training, and information, with a focus on practical solutions that improve services where resources are scarce. EngenderHealth believes that individuals have the right to make informed decisions about their reproductive health and to receive care that meets their needs. ey work in partnership with governments, institutions, and health care professionals to make this right a reality. International Agency for Research on Cancer (IARC) 150 Cours Albert omas 69372 Lyon CEDEX 08, France Tel: 33-0-4 72 73 84 85 Fax: 33-0-4 72 73 85 75 Email: com@iarc.fr www.iarc.fr e International Agency for Research on Cancer (IARC) is part of the World Health Organization. IARC’s mission is to coordinate and conduct research on the causes of human cancer and the mechanisms of carcinogenesis, and to develop scientific strategies for cancer control. e agency is involved in both epidemiological and laboratory research and disseminates scientific information through publications, meetings, courses, and fellowships. e agency’s work has four main objectives: (1) monitoring global cancer occurrence, (2) identifying the causes of cancer, (3) elucidating the mechanisms of carcinogenesis, and (4) developing scientific strategies for cancer control. WHO IARC viii ix JHPIEGO 1615 ames Street Suite 200 Baltimore, MD 21231, USA Tel: 410-537-1800 Fax: 410-537-1474 Email: info@jhpiego.net www.jhpiego.org JHPIEGO, an affiliate of Johns Hopkins University, builds global and local partnerships to enhance the quality of health care services for women and families around the world. JHPIEGO is a global leader in the creation of innovative and effective approaches to developing human resources for health. Pan American Health Organization (PAHO) 525 23rd St. N.W. Washington, D.C. 20037, USA Tel: 202-974-3000 Fax: 202-974-3663 Email: publinfo@paho.org www.paho.org e Pan American Sanitary Bureau (PASB), the oldest interna- tional health agency in the world, is the Secretariat of the Pan American Health Organization (PAHO). e bureau is committed to providing technical support and leadership to PAHO member states as they pursue their goal of health for all and the values therein. PASB will be the major catalyst for ensuring that all people of the Americas enjoy optimal health and contribute to the well-being of their families and communities. e mission is to lead strategic collaborative efforts among member states and other partners to promote equity in health, to combat disease, and to improve the quality of, and lengthen, the lives of the peoples of the Americas. PATH 1455 NW Leary Way Seattle, WA 98107, USA Tel: 206-285-3500 Fax: 206-285-6619 Email: info@path.org www.path.org PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions, enabling communi- ties worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropri- ate health technologies and vital strategies that change the way people think and act. PATH’s work improves global health and well-being. x xi Acknowledgments e Alliance for Cervical Cancer Prevention (ACCP) wishes to acknowledge the following individuals for their long-term involvement in conceptualizing, planning, information gathering, writing, reviewing, and revising of Planning and Implementing Cervical Cancer Prevention and Control Programs: A Manual for Managers: EngenderHealth: Mark Barone, DVM, MS Jan Bradley, MA Ilana Dzuba, MHS Martha Jacob, FRCOG, MPH International Agency for Research on Cancer (IARC): Cédric Mahé, PhD R. Sankaranarayanan, MD JHPIEGO: Paul Blumenthal, MD, MPH Robbyn Lewis, MPH Pan American Health Organization (PAHO): Merle Lewis, DrPH, MPH Silvana Luciani, MHSc PATH: John Sellors, MD, FCFP Kristen Lewis, MPH Martha Jacob took the lead in coordinating the development of this manual. Revisions and restructuring of the manual aer review were done by a core group comprising Cédric Mahé, Silvana Luciani, and Martha Jacob. Jill Tabbutt-Henry, MPH, consultant, was the developmental editor. Margo Lauterbach contributed to an earlier dra of Chapter 8. anks to Anna Kurica (EngenderHealth) for revising and refining the illustrations and to Sharone Beatty (EngenderHealth) for assisting coordinating the extensive review process and compiling the pictures for the manual. anks to Evelyn Bayle (IARC), Sophie Sibert (IARC), Sharone Beatty, Deirdre Campbell (PATH), Pilar Fano (PAHO), and Victoria Robinson (JHPIEGO) for the administrative support provided during the entire process. Several people at PATH were involved in finalizing this document. Cristina Herdman and Anne R. Boyd coordinated the publication development process, and Cristina Herdman was the content editor. Jacqueline Sherris provided guidance throughout the editorial and production stages. Jack Kirshbaum copyedited the final manuscript, and Jessie Gleckel organized the references. Barb Rowan designed the publication with layout assistance from NanCee Sautbine and Scott Brown. Janet Saulsbury and Patrick McKern proofread the document. x xi e ACCP gratefully acknowledges all the individuals listed below who reviewed either selected chapters or the whole manual and provided constructive feedback in a timely manner. e manual greatly benefited from their feedback. Nevertheless, the responsibility for the final content rests with the ACCP. Dr. Ornela Abazi, Albania Family Planning Association, Albania Dr. Irene Agurto, PAHO, USA Dr. Jean Ahlborg, EngenderHealth, USA Ms. Anna Alexandrova, Health Psychology Research Center, Bulgaria Dr. Biljana Ancevska Stojanovska, Institute for Mother and Child Health Care—Health Center, Macedonia Ms. Silvina Arrossi, IARC, France Dr. Stefan Bartha, Ministry of Health, Romania Dr. Partha Sarathi Basu, Chittaranjan National Cancer Institute, India Dr. Ana Jovicevic Bekic, Institute for Oncology and Radiology of Serbia, Serbia and Montenegro Dr. Neerja Bhatla, All India Institute of Medical Sciences (AIIMS), India Ms. Amie Bishop, PATH, USA Ms. Anne R. Boyd, PATH, USA Dr. Nathalie Broutet, World Health Organization (WHO), Switzerland Dr. Patricia Claeys, International Centre for Reproductive Health (ICRH), Ghent University, Belgium Dr. Patricia Coffey, PATH, USA Dr. Stephen Corber, PAHO, USA Dr. Maria Cumpana, Ministry of Health, Moldova Ms. Rasha Dabash, consultant, USA Dr. Angie Dawa, PATH, Kenya Dr. Michelle De Souza, Khayelitsha Cervical Screening Project, South Africa Dr. Irena Digol, Against Infectious Diseases in Obstetrics and Gynecology, Moldova Dr. Miguel Espinoza, PAHO, USA Dr. Abu Jamil Faisel, EngenderHealth, Bangladesh Dr. Irena Kirar Fazarinc, Institute of Oncology Ljubljana, Slovenia Dr. Antonio Filipe, WHO, AFRO, Congo Dr. Lynne Gaffikin, JHPIEGO/CECAP, USA Dr. Pamela Godia, Ministry of Health, Kenya Dr. Sue J. Goldie, Harvard School of Public Health, USA Dr. Amparo Gordillo-Tobar, PAHO, USA Dr. Susan J. Griffey, JHPIEGO, USA Dr. Wendel Guthrie, Jamaica Cancer Society, Jamaica xii xiii Ms. Cristina Herdman, PATH, USA Dr. Nadica Janeva, Institute for Mother and Child Health Care— Health Center, Macedonia Ms. Kasturi Jayant, India Ms. Anna Kaniauskene, EngenderHealth, USA Dr. Mary Kawonga, Women’s Health Project, South Africa Dr. Nancy Kidula, consultant obstetrician and gynecologist, Kenya Dr. Leah Kirumbi, Kenya Medical Research Institute (KEMRI), Kenya Ms. Georgeanne Kumar, EngenderHealth, USA Dr. Nisha Lal, EngenderHealth, India Dr. Victor Levin, consultant, International Atomic Energy Agency, Austria Dr. Neil MacDonald, McGill University, Canada Dr. Ian Magrath, International Network for Cancer Treatment and Research (INCTR), Belgium Dr. Anthony Miller, Canada Dr. Jennifer Moodley, Women’s Health Research Unit, University of Cape Town, South Africa Dr. Ketra Muhombe, Kenya Cancer Association (KECANSA), Kenya Dr. Hextan Y.S. Ngan, University of Hong Kong, Hong Kong Dr. Twalib Ngoma, Ocean Road Cancer Institute (ORCI), Tanzania Dr. Max Parkin, IARC, France Ms. Julietta Patnick, NHS Cancer Screening Programme, United Kingdom Dr. Ljuben Risteski, Health Center—Skopje, Macedonia Dr. Sylvia Robles, PAHO, USA Dr. Chandrakant Ruperalia, JHPIEGO, Ethiopia Dr. Debbie Saslow, American Cancer Society, USA Dr. Rhonda Sealey-omas, PAHO, USA Ms. Kathy Shapiro, consultant, Switzerland Dr. Jacqueline Sherris, PATH, USA Dr. Sherian Slater, Ministry of Health, St. Vincent and the Grenadines Dr. Emiliya Tasheva, Ministry of Health, Bulgaria Ms. Lidija Topic, Institute of Social Sciences, Serbia and Montenegro Dr. Vivien Tsu, PATH, USA Dr. Andreas Ullrich, WHO, Switzerland Dr. Bhadrasain Vikram, International Atomic Energy Agency, Austria Dr. Cristian Vladescu, Center for Health Policies and Services, Romania Dr. Damien Wohlfahrt, EngenderHealth, Kenya Dr. Eduardo Zubizaretta, International Atomic Energy Agency, Austria xii xiii About the Manual Unlike most other cancers, cervical cancer can be prevented through screening programs designed to identify and treat precancerous lesions. Still, more than 490,000 new cases of cervical cancer occur among women worldwide each year (Ferlay et al. 2004). Approximately 80% of all cases of cervical cancer worldwide occur in less-developed countries, because prevention programs are either non- existent or poorly executed. In response to this situation, the ACCP has collabo- rated in over 50 countries to: • Assess innovative approaches to screening and treatment. • Improve service delivery systems. • Ensure that community perspectives and needs are incorporated into program design and used to develop appropriate mechanisms for increasing utilization. • Heighten awareness of cervical cancer and effective prevention strategies. Planning and Implementing Cervical Cancer Prevention and Control Programs: A Manual for Managers has been developed to help management teams plan, imple- ment, and monitor cervical cancer prevention and control services. ese teams consist of program directors, district and facility managers, supervisors, trainers, administrators, and technical advisors, depending on the different countries or programs. Ultimately, this manual aims to contribute to global efforts to improve women’s health by promoting appropriate, affordable, and effective service delivery mechanisms for cervical cancer prevention and control. e manual focuses on the generic program elements crucial to the success of cervical cancer prevention and control programs and deals with the full continuum from prevention via screening and treatment to palliative care. It presents various service delivery options applicable to different geographic and cultural settings, and to a range of resource levels. Management teams will need to select program approaches that best suit their specific setting and program goals. is manual is written on the assumption that certain key decisions have already been made by national or subnational policymakers about the specifics of the cervical cancer prevention program that will be put in place in their country, region, state, or province. Such decisions include what screening and treatment options and service delivery approach to use, target age group, coverage goals, screening frequency, regulations permitting providers at various levels to perform necessary procedures, and whether to establish vertical or integrated programs. erefore, detailed information on guidelines for clinical practice and policy decisions for cervical cancer prevention and control are not included in this document. For such information, the reader should refer to documents such as the World Health Organization’s (WHO) forthcoming publication, Comprehensive Cervical Cancer Control: A Guide for Essential Practice, the International Agency for Research on Cancer’s (IARC) forthcoming Handbooks of Cancer Prevention, Volume 10: Cervix Cancer Screening, and WHO’s National Cancer Control Programmes: Policies and Managerial Guidelines. However, basic information is provided heree.g., features xiv xv and resources required for the various screening and treatment options and service delivery approaches—to assist the management team in implementing the policy decisions. e four parts of this manual provide the information required for the key tasks to be carried out by management teams. Although the chapters follow a logical sequence for planning and implementing a program, each chapter can also be read independently, with cross-referencing where appropriate between the chapters. Countries in which ACCP activities have been conducted Africa: Angola, Burkina-Faso, Cameroon, Congo, Ethiopia, Ghana, Guinea, Kenya, Malawi, Mali, Mauritania, Niger, South Africa, Sudan, Tanzania, Uganda, and Zimbabwe Latin America and the Caribbean: Antigua and Barbuda, Argentina, Bolivia, Colombia, Dominican Republic, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Trinidad and Tobago, and Venezuela South and South East Asia: India, Laos, Nepal, ailand, and Vietnam Eastern Europe and Central Asia: Albania, Armenia, Bulgaria, Georgia, Kazakhstan, Kyrgyzstan, Lithuania, Macedonia, Moldova, Mongolia, Russia, Serbia and Montenegro, and Ukraine xiv xv Executive Summary Cervical cancer continues to claim the lives of tens of thousands of women who could have been saved through relatively simple screening for and treatment of pre- cancerous lesions. is tragedy is particularly stark in developing countries, where the burden of disease is heaviest and access to effective prevention services is quite limited. Since 1999, the Alliance for Cervical Cancer Prevention (ACCP) has been implementing research and demonstration projects in many limited-resource coun- tries to characterize the key clinical and programmatic aspects of effective cervical cancer prevention. is document aims to help management teams at the national or subnational level to plan, implement, and monitor cervical cancer prevention and control services. Ultimately, the manual aims to contribute to global efforts to improve women’s health by promoting appropriate, affordable, and effective service delivery mechanisms for cervical cancer prevention and control. Part One: Background Cervical cancer screening and treatment are justified based on the principles of public health screening. e slow progression of precancerous lesions to cervical cancer provides a window of ten years or more to detect and treat the lesions, thus preventing their progression to invasive cancer. Effective cervical cancer preven- tion programs can be implemented in low-resource settings and should focus on three critical factors: achieving high screening coverage, offering an effective and acceptable test, and ensuring appropriate treatment of test-positive women. Various cervical cancer screening, diagnostic, and treatment methods are currently being used in developed and developing countries. Each has strengths and limita- tions that need to be considered in the national policy-level decisions about which methods to use. Cytology, the screening test most commonly used in developed countries, requires multiple visits by the client, screening at regular intervals, and sufficient laboratory infrastructure. ese are barriers that can, and indeed have, limited the effectiveness of cervical cancer prevention in low-resource countries. Alternatives to the traditional screening approaches exist. For example, visual screening methods such as visual inspection with acetic acid (VIA) or visual inspec- tion with Lugol’s iodine (VILI) are low-cost approaches with an immediate result. Test specificity, however, is moderate, and so a considerable proportion of women tested with VIA or VILI will be unnecessarily treated or referred for further man- agement. Human papillomavirus (HPV) DNA testing, another alternative screening approach, is a new technology that has better sensitivity than cytology and visual tests and has moderate specificity, but technical, cost, and infrastructure require- ments can make it difficult to implement. Screening methods should be combined with relatively simple, safe, and effective outpatient methods for the treatment of precancer, such as cryotherapy or loop electrosurgical excision procedure (LEEP). Cryotherapy can be performed by phy- sicians and non-physicians, at all levels of health care facilities; it has been shown to have very low morbidity and is acceptable to women, their partners, and provid- ers in a variety of low-resource settings. LEEP is usually performed by physicians with colposcopic guidance and requires local anesthesia, as well as a continuous supply of power and relatively more sophisticated equipment. e major practical difference between the two methods is that LEEP involves excision of the tissue xvi xvii and hence provides a tissue specimen that allows for histological verification of the diagnosis. On the other hand, cryotherapy is an ablative method that can be used to destroy tissue and leaves no sample for histology. When screening tests with the inherent potential for overtreatment, such as visual methods or HPV testing, are combined with an outpatient treatment method that is safe, relatively inexpensive, and acceptable, the overall benefit can outweigh the limitations. Irrespective of the screening and treatment methods chosen, the focus should be on linking screening services with precancer treatment services in order to increase women’s access to these services. is manual presents various service delivery options applicable to different geographic and cultural settings and to a range of resource levels, keeping in mind that reducing delays and the number of clinic visits for screening, treatment, and follow-up increases program effective- ness. Managers will need to select program approaches that best suit their specific setting and program goals. Obtaining widespread coverage of the target population is essential and is most readily achieved through well-managed and coordinated prevention programs. If a situation analysis examining country needs and resources suggests that it is rea- sonable to invest in a cervical cancer prevention program, national policy decisions will need to be made regarding the types of screening and treatment methods to be used, the age to initiate screening, how oen to screen, and the desired population coverage level. In addition, sufficient resources will need to be committed to all aspects of cervical cancer prevention and control. is manual offers programmatic guidance to the management team with the assumption that these policy decisions have already been established. It focuses on the program elements crucial to the success of a cervical cancer prevention effort regardless of the screening and treat- ment approaches used, and discusses the continuum from prevention by screen- ing and treatment to palliative care. Part Two: Planning and Managing a Program During the policy phase a program coordinator will be designated with the appro- priate mandate, authority, and resources to direct the program. e program coor- dinator should establish a multidisciplinary management team, and the coordinator and the team together should be accountable for directing the program. e mul- tidisciplinary group should include clinical, administrative, and training special- ists who are actively involved in the planning, implementation, and evaluation of a cervical cancer prevention program. Sufficient time should be allowed to prepare a careful program plan and budget based on an assessment of local needs and capacities. e plan should ensure that the three components of service delivery— community information and education (I&E), screening services, and diagnos- tic and/or treatment services—are closely linked. Program policy, training, and monitoring and evaluation provide the programmatic foundation that is essential for success. Engaging key stakeholders in planning a new program or strengthening existing services is a critical first step to establishing an effective, sustainable cervical cancer prevention effort. eir input can be invaluable, and their involvement at the earliest stages can ensure their commitment to and support for program activities. A local needs assessment examining technical and infrastructural capacities and information needs enables the management team to identify what inputs are xvi xvii required to achieve the objectives of a cervical cancer prevention program. e assessment is best conducted through a participatory process involving a multidis- ciplinary team of stakeholders and obtaining the perspectives of the people involved in providing and those receiving prevention services. Based on the findings of the needs assessment and cost-effectiveness considerations, the management team can elaborate a program plan that describes a step-by-step process for reaching the program’s goals of achieving high screening coverage, offering a high-quality and effective screening test, and ensuring that women with positive screening test results receive treatment. e management team’s role is to map out local strat- egies that cover all programmatic areas, including defining local programmatic targets, developing local service delivery strategies, and determining the equip- ment, training, and resources needed at each site. Building capacity and systems for service delivery, supervision, monitoring, and evaluation are essential prior to implementing the program. is includes devel- oping all program materials; distributing all equipment and supplies; orienting community, stakeholders, and staff; ensuring providers are trained and available; creating systems for ensuring quality; and setting up an information system. Local area supervisors should be designated to oversee implementation and to coordi- nate with the management team. Part Three: Implementing Key Aspects of a Program Delivering Clinical Services and Strengthening Linkages e main goal of service delivery is to enable eligible women to have maximum access to quality cervical cancer screening and treatment services. Women in many countriesparticularly in rural areas—have limited access to health services. Simply making the services available, however, is insufficient to ensure that they are used. Services need to be accessible, acceptable, affordable, and reliable. For example, programs that reduce the number of clinic visits required for screening, treatment, and follow-up make it easier for women to receive the care they need, improve follow-up rates, and reduce program costs. Cervical cancer prevention services include counseling, a screening test (with or without a diagnostic test), and precancer treatment for women who test positive. ese services can be provided at various levels of health facilities by a wide range of health personnel. Programs can implement a health facility-based (static) approach, a mobile (outreach) approach, or combine the two approaches. In addition, a well- functioning referral network is essential to ensure continuity of care for women needing additional diagnostics and treatment. Trained community health workers/ volunteers can be engaged to build and maintain links with the community—to encourage women to utilize the service, to track women who need to be treated and followed up, and to provide community-based palliative care. Lastly, to ensure availability and reliability of services, an efficient supply distribution and logistics chain should be in place. Providing Information and Counseling to Address Community and Client Needs To increase use of cervical cancer prevention services, an I&E plan—combining community-, facility-, and media-based strategies—should be implemented to inform women in the target age group and their partners about the benefits and xviii xix availability of cervical cancer prevention services. Direct contact between those in the target population and health workers or peer educators is oen more effective in increasing use of services than short-term media activities. Group education, followed by individual counseling, can address clients’ information and emotional needs, motivate them to follow treatment recommendations, and establish a sat- isfied clientele who will encourage other women to attend. Printed materials are helpful for education and counseling, but they should not replace direct provider contact. Training: Ensuring Performance to Standard e goal of training in a cervical cancer prevention program is to ensure that there are sufficient competent staff to attract women to services, screen eligible women with an appropriate test, and treat eligible test-positive women. A training plan— specifying who, what, how, where, and when training will be conducted, plus how much it will cost—should be based on programmatic goals, with special attention given to achieving coverage and maintaining quality of care. Competency-based training that includes a combination of didactic, simulated, and hands-on (practi- cal) approaches enables providers to confidently offer the services. Clinical training should be conducted just before launching services; a long delay between training staff and providing services to the clients could result in a loss of skills. To sustain the program, a system should develop and support an in-country pool of trainers capable of training new providers. is system would promote the transfer of learning through post-training follow-up, including refresher courses. Improving Program Performance Program performance means progress towards achieving defined programmatic targets, such as screening coverage and treatment of all women who test positive. Monitoring and evaluation are essential to ensure that all aspects of care function effectively and efficiently. It should be a continuous process and derive from the interaction of information systems, quality assurance systems, and self-assessment by health workers through a participatory quality improvement process. A health information system (HIS), based on valid and measurable indicators, is an essential tool for monitoring and evaluating program performance. Such a system can be managed at the facility or central level. Regardless of which model of HIS is used, good-quality data are essential, which requires that staff are trained in data collection, data entry, and report preparation. Having a staff member responsible for maintaining communication linkages between health facilities, distributing forms, aggregating data, and dispatching reports is key to ensuring the flow and quality of information. Data quality should be emphasized over quantity, and data should be used for monitoring and evaluation or decision-making purposes. Monitoring should aim to improve the quality of services. Improved quality con- tributes to efficiency and cost savings, promotes job satisfaction, and attracts clients. Client satisfaction, though difficult to measure, can affect utilization of services, which in turn affects program performance. Qualitative tools and approaches are available and can be used to continuously and proactively monitor services, analyze problems, and develop solutions to improve quality of services. xviii xix Part Four: Overview of Cervical Cancer Treatment and Palliative Care Cervical cancer prevention services should be linked with cervical cancer treat- ment and palliative care services, and wherever possible, integrated into a national cancer control plan. Information and education activities should create awareness, for both providers and clients, that cervical cancer is oen curable with appropriate treatment. e management team should strengthen and increase the availability of radical surgery, if such potential exists, and improve access to available radiotherapy services. Palliative care services should be strengthened at all levels of health facilities, including community-level care. In addition to managing pain and other cancer symptoms, palliative care includes providing support at the community level to mobilize local resources; establishing links to treatment centers; and offering emo- tional, social, and spiritual support to terminally ill women and their caregiv- ers. Drug regulation and medical and pharmaceutical policies may unnecessarily restrict access to appropriate medications, particularly in rural areas; these should be evaluated and revised as needed. Conclusion Programs should be planned strategically, be based on realistic assessment of needs and capacities, and utilize the most recent evidence on screening and treat- ment approaches. e poor performance of cervical cancer prevention programs in some limited-resource settings has most oen been the result of poor planning and implementation and lack of systems for ongoing monitoring and evaluation, irrespective of the screening test or treatment methods used. Establishing mech- anisms and processes to support and sustain each component of a program will go far to ensuring that services are effective, accessible, and acceptable to women who need them. Background P A R T One Part One of this manual provides background information upon which cervical cancer prevention programs can be based. Chapter 1 includes information on the magnitude of the problem, the natural history of the disease, screening and treatment methods, and the rationale for implement- ing a prevention program. Chapter 2 offers an overview of policy issues that most directly affect service delivery and program management. ough all individuals responsible for planning and implementing a program may not be involved in making policy-level decisions, they must be aware of and understand the policies that will impact program effec- tiveness. 2 Part One: Background 1 3Chapter 1: Rationale for Cervical Cancer Prevention 1Rationale for Cervical Cancer Prevention Contents Key Messages . 3 Introduction . 3 Burden of Disease . 3 Natural History of Cervical Cancer . 5 Methods of Cervical Cancer Prevention . 7 Screening tests Diagnosis and confi rmation Treatment of precancerous lesions Linking screening and treatment Justifi cation for Cervical Cancer Screening . 12 Conclusion . 14 Further Reading . 14 Appendix 1.1. Characteristics of Screening Tests . 15 1 C H A P T E R 2 Part One: Background 1 3Chapter 1: Rationale for Cervical Cancer Prevention 1 Key Messages • Cervical cancer screening and treatment are justified, based on the general principles of public health screening. • Unlike many other cancers, cervical cancer is mostly preventable. Because of the slow progression of cervical precancer to cervical cancer, there is a window of up to ten years or more to detect and treat pre- cancerous lesions and prevent their progression to invasive cancer. • Various screening tests are available. All options for screening and for treatment of cervical precancer have strengths and limitations that need to be considered during policymaking, planning, and implementation phases of cervical cancer screening programs. • Regardless of the screening test used, the focus should be to maximize coverage and link screening and treatment services. e feasibility of the different approaches for linking screening and treatment depends upon available resources in the given setting. • Cryotherapy can be performed by physicians and non-physicians, at all levels of health care facilities. It has been shown to be safe and accept- able to women, their partners, and providers. Introduction To assist the management team in building support for prevention efforts, this chapter presents basic information about the burden of disease from cervical cancer and its natural history. It also discusses available methods for the preven- tion of cervical cancerscreening tests, outpatient methods for treatment of pre- cancer, and management approaches for women with abnormal tests. It is beyond the scope of this document to provide detailed technical information on different screening tests and treatment options or to provide specific guidance on how to decide which would be best suited to any given setting. Additional information can be found in the Further Reading section of each chapter of this manual. Burden of Disease Cervical cancer is the most common cause of cancer deaths among women in developing countries (Ferlay et al. 2004), despite the fact that cervical cancer is preventable. e incidence of cervical cancer by country is shown in Figure 1.1. It should be noted that data on cervical cancer incidence and mortality are more accurate in countries that have cancer registries. Accurate data are not available from most developing countries, and underreporting is high. 4 Part One: Background 1 5Chapter 1: Rationale for Cervical Cancer Prevention 1 In South Asia and Latin America the rate of cervical cancer has declined slightly over the last two decades or has remained stable, but incidence rates are increasing in sub-Saharan African countries such as Uganda, Mali, and Zimbabwe (Parkin et al. 2001, Parkin et al. 2002, Wabinga et al. 2000). As shown in Table 1.1, in some developing countries such as Argentina, Chile, China, Peru, South Africa, and ailand, cervical cancer kills more women than maternal mortality (Parkin et al. 2002, WHO 2001a). TABLE 1.1. A comparison of deaths from cervical cancer and maternal mortality in selected developing countries in 2000 Country Cervical cancer deaths Maternal deaths Argentina 1,679 590 Brazil 8,286 8,700 Chile 931 90 Peru 2,663 2,500 South Africa 3,681 2,600 China 25,561 11,000 India 74,118 136,000 ailand 2,620 520 Sources: Ferlay et al. 2004, AbouZahr and Wardlaw 2004. FIGURE 1.1. Estimated age-standardized incidence of new cervical cancer cases per 100,000 women in 2002 Source: Adapted from Ferlay 2004. Rate (cases per 100,000 women) ≤10 10.1–20 20.1–30 30.1–40 >40 No data 4 Part One: Background 1 5Chapter 1: Rationale for Cervical Cancer Prevention 1 Natural History of Cervical Cancer Understanding how cervical cancer develops is essential to designing effective interventions to prevent deaths from this disease. More than 99% of cervical cancer cases and its precursors are related to infection with HPV, a sexually transmitted infection (STI) that is mostly asymptomatic (Walboomers et al. 1999). HPV is the most common STI worldwide, affecting an estimated 50 to 80% of sexually active women at least once in their lifetime (Koutsky 1997, Crum et al. 2003). Women are mostly infected with HPV in their teens, 20s, or early 30s. Cervical cancer is essentially a rare complication of a common STI. Currently more than one hundred types of HPV have been identified, of which more than 30 types are known to cause genital infection. ese are broadly clas- sified as high-risk and low-risk for cervical cancer, with approximately a dozen types considered high-risk (some of the low-risk types are associated with genital warts). Infection of the cervix with high-risk types of HPV can lead to cervical abnormalities which, le untreated, progress to cervical cancer in some women (see Figure 1.2). Most HPV infections are transient, however, meaning that the body’s defense mechanisms eradicate them, without posing any risk of progressing to cancer (Elfgren et al. 2000, Ho et al. 1998, Nobbenhuis et al. 1999). For reasons that are not fully understood, approximately 5% to 10% of women infected with high-risk types of HPV develop persistent infections. Evidence shows that these women have an increased risk of developing high-grade precancerous lesions, and, if the lesions are not treated, cervical cancer (Bosch et al. 2002, Ho et al. 1998, Hopman et al. 2000, Muñoz and Bosch 1996, Nobbenhuis et al. 1999, Schiffman et al. 1993, Walboomers et al. 1999). It is not possible to predict in which women precursor lesions will progress to cancer, because the environmen- tal and host immunological factors associated with progression to cancer are also not fully understood. FIGURE 1.2. The natural history of cervical cancer Photo source: Wright TC Jr, Schiffman M. Adding a test for human papillomavirus DNA to cervical-cancer screening. New England Journal of Medicine. 2003;348(6):489–490. ©2003 Massachusetts Medical Society. All rights reserved. 6 Part One: Background 1 7Chapter 1: Rationale for Cervical Cancer Prevention 1 Table 1.2 summarizes information on HPV infection, cervical precancer, and invasive cancer. HPV infection can lead to low-grade lesions. Most of these lesions either regress on their own or do not progress to high-grade lesions or cancer (PATH 2000). High-grade lesions can develop directly from persistent HPV infection or from low- grade lesions (Cox 2001, PATH 2000). Some high-grade lesions will progress to invasive cancer over a period of up to ten years. erefore, there is ample time to identify and treat infected women before cervical cancer develops (Miller 1992, Jenkins et al. 1996). Most low-grade lesions either regress on their own or do not progress to high-grade lesions or cancer (PATH 2000). Cervical cancer most oen develops in women aer age 40, and the incidence is highest among women in their 50s and 60s (Miller 1992, Parkin 1997). TABLE 1.2. HPV infection, cervical precancer, and invasive cervical cancer HPV infection Low-grade lesions High-grade lesions Invasive cancer HPV infection is extremely common among women of reproductive age. e infection can persist, lead to cervical abnor- malities, or resolve on it own. Low-grade lesions are usually temporary and disappear over time. Some cases, however, progress to high-grade lesions. High-grade lesions, the precursor to cervical cancer, are significantly less common than low- grade lesions. High- grade lesions can develop from low- grade ones or directly from persistent HPV infection. Invasive cancer develops over the course of several years and is most common among women in their 50s and 60s. Source: Adapted from PATH 2000. e understanding that HPV is the necessary but not solely sufficient precur- sor to cervical cancer has focused attention on the potential for primary preven- tion. Risk factors for HPV—such as early onset of sexual activity, multiple lifetime sexual partners (of a woman or her partners), and history of other STIs—gener- ally reflect sexual activity. erefore, primary prevention efforts have focused on reducing infection by reducing the number of sexual partners and encouraging the use of barrier contraceptives, especially condoms (Centers for Disease Control and Prevention 2004, Lytle et al. 1997, Weaver et al. forthcoming). Limited data suggest, however, that these efforts would achieve only minimal effect; in particular, research has demonstrated a weak association between the use of barrier contraceptive methods and a decreased risk of HPV infection (Kjaer et al. 1997, Lytle et al. 1997, Lazcano-Ponce et al. 2001, Molano et al. 2002, Plummer and Franceschi 2002, Shepherd et al. 2000a,b). is is likely because men and women infected with HPV can harbor the virus both on the internal and external genitalia, including areas not protected by condoms. Further, individuals can harbor HPV infection for long durations without knowing they are infected; therefore, even mutually monogamous couples may transmit infections obtained in a previous relationship to a current partner. e most promising approach to primary prevention of cervical cancer is through development and broad provision of effective HPV vaccines. It is expected that 6 Part One: Background 1 7Chapter 1: Rationale for Cervical Cancer Prevention 1 prophylactic vaccines against HPV 16 and 18 (which account for about 70% of cervical cancer cases) are likely to become commercially marketed in some devel- oping countries before 2010. Early data suggest that these vaccines are likely to be effective in preventing certain types of HPV infection and precancer (cervical intraepithelial neoplasia [CIN]); their long-term impact on cancer rates will not be known for many years aer introduction (Koutsky et al. 2002). Even aer these prophylactic vaccines become available, it will be important to continue screening and treatment programs for the many women already exposed to HPV as well as for women infected with carcinogenic HPV types other than HPV 16 or 18. Methods of Cervical Cancer Prevention Screening tests Screening involves testing a target group (in this context, women) who are at risk for a given disease (in this context, cervical precancer). e aim of screening is to detect and treat those people identified as having early signs of the disease, usually by means of an inexpensive, accurate, and reliable test that can be applied widely. ere are several cervical cancer screening tests in use or being studied around the world. Cervical cytology has been in use for the past 50 years. Newer screen- ing tests are HPV DNA testing and visual screening tests. Each of these tests has potential advantages and disadvantages. e tests are briefly described below, with some additional technical information, plus strengths and limitations, presented in Appendix 1.1. No screening test is perfect, and the advantages and disadvan- tages need to be carefully weighed in any particular setting when deciding which test or tests to use. Traditional screening methods Cervical cytology Conventional cervical cytology—also referred to as the Papanicolaou test, Pap test, Pap smear, and cervical smear—detects abnormal cells in a sample taken from the cervix. It involves performing a speculum examination to expose the cervix and the os, and collecting cervical cells using a wooden or plastic spatula, broom, or brush. ese cells are then smeared and fixed on a glass microscope slide. e slides are transported to a laboratory where they are usually processed manually. Each slide is then evaluated under the microscope by a trained cytology technician. is multistage process can take several weeks before the results are available to the client, although in well-organized programs results can be avail- able sooner. Liquid-based cytology (LBC) testing is a new technique that provides a uniform thin layer of cervical cells without debris. It is a more expensive test than conven- tional cytology and requires additional supplies and sophisticated equipment to process the smear. e impact of LBC on cancer incidence and mortality remains to be established, as does its cost-effectiveness. For further reading on cytology and cytology laboratory services, refer to WHO, Cytological Screening in the Control of Cervical Cancer: Technical Guidelines (1988), and to PAHO/WHO, Pan American Cytology Network. An Operations Manual (2001). Existing cervical cancer prevention programs are nearly all cytology-based. Cervical cytology is the screening test that has been most widely used since the middle of 8 Part One: Background 1 9Chapter 1: Rationale for Cervical Cancer Prevention 1 the twentieth century in developed countries and in those developing countries where screening is available. Well-organized and well-implemented cytology- based screening programs that screen women at regular intervals have been asso- ciated with measurable reductions in cervical cancer incidence and mortality when screening coverage and the treatment rate of women with abnormal findings are high. However, sensitivity and specificity of cytology have not been consistently high in a range of settings, especially in those with limited resources (see Appendix 1.1). Cytology-based programs can be implemented effectively only if infrastruc- ture and laboratory quality assurance requirements are consistently met. New screening methods HPV DNA test e currently available test, Hybrid Capture 2, determines if one or more of the high-risk types of HPV virus (those associated with cervical cancer) are present in a cervical specimen. HPV DNA testing usually involves a speculum exam to obtain a sample of cervical cells using a brush or swab. e sample is transported to a laboratory for processing. Where such laboratory services have been established, an automated system can process 70 to 90 specimens at a time, requiring a total processing time of about seven hours. e results can potentially be returned to the service site in a day. Use of self-collected samples, where no speculum exam is needed, has been explored, and it has been shown that self-col- lected specimens have adequate sensitivity and are a culturally acceptable method in some settings (Wright et al. 2000, Dzuba et al. 2002). Although the technical, cost, and infrastructure requirements can make the HPV DNA test difficult to implement, available data suggests that it performs better than cytology and visual tests in detecting precancerous lesions among women in their 30s and 40s (see Appendix 1.1 for general information on test performance). Efforts are ongoing to develop simple, inexpensive HPV DNA tests that can provide quicker results. By 2010, ACCP studies are expected to have evidence on long-term impact of HPV DNA testing on cervical cancer incidence rates. Visual tests: VIA and VILI ere are two kinds of visual tests to identify precancerous cervical lesions. In visual inspection with acetic acid (VIA), sometimes referred to as direct visual inspection (DVI), precancerous lesions temporarily appear white aer staining with acetic acid (vinegar). Like cervical cytology and HPV DNA testing, VIA involves a speculum examination and exposing the cervix and the os. Aer swabbing the cervix with 3%–5% acetic acid using a cotton applicator, abnormal areas have a distinctive white appearance. VIA can be implemented in a wide range of settings. No laboratory processing is required, the results are immediate, and treatment can be provided in the same visit. Due to the subjective nature of visual assessment, it is important to standardize definitions for positive and negative tests, and to give special attention to regular and consistent quality assurance (Denny et al. 2002). While in most studies to date the sensitivity of VIA has been equivalent to or better than cytology, its specificity has been lower (see Appendix 1.1). By 2010, ongoing ACCP studies will provide evidence of the impact of VIA on cancer incidence rates. e second test is visual inspection with Lugol’s iodine (VILI). Like VIA, VILI involves temporarily staining the cervix—this time with Lugol’s iodine. Normal cells take up the iodine stain and appear a mahogany-brown color, whereas precancerous cervical lesions appear yellow. Like VIA, results for VILI are immediate, treatment can be provided in the same visit, and it may be implemented in a wide range of 8 Part One: Background 1 9Chapter 1: Rationale for Cervical Cancer Prevention 1 settings. VILI may perform better than VIA, but further evaluation is needed to demonstrate the effectiveness of VILI in a variety of settings, as well as the impact of VILI as a screening test on the reduction of cervical cancer incidence. Diagnosis and confirmation Conventionally, cytology-based screening is linked to treatment through an inter- mediary diagnostic step using colposcopy, followed by confirmatory biopsy when indicated. Endocervical curettage (ECC) or an endocervical smear can be used to sample the endocervical canal. Laboratory assessment of the tissue samples obtained by biopsy (histology) confirms the presence or absence of CIN in pre- cancer stages and cervical cancer itself. Colposcopy involves high-powered illuminated magnification of the cervix using a colposcope—a binocular magnifying instrument (see p. XX). is enables pro- viders to determine the extent of lesions and is useful in taking biopsies and in providing directed treatment with cryotherapy or loop electrosurgical excision procedure (LEEP). Colposcopy is noninvasive and performed as an outpatient procedure. It does not require anesthesia. Colposcopes are expensive—with cost ranging from US$800 to $13,000—and providers require specialized training and experience to use them proficiently. ACCP studies in India and Africa show that including colposcopy as an intermediary step reduces overtreatment; but colpos- copy may not be practical in many low-resource settings due to the costs of equip- ment and training. Treatment of precancerous lesions e ability to offer women appropriate and effective treatment for precancerous lesions is a critical component of a successful cervical cancer prevention program. Safe and effective outpatient methods are preferred for management of precancer- ous lesions. In many limited-resource countries, however, clinicians lack training and experience and oen the essential equipment and supplies required for simple outpatient treatment procedures. Hence they rely on more costly and complex inpatient methods such as cold-knife conization or hysterectomy performed under general or regional anesthesia by skilled specialists. Although these invasive pro- cedures might be appropriate in special circumstances, they should be used judi- ciously since they can be associated with significant complications, including bleeding, pelvic infection, and injury to adjacent pelvic organs. Cryotherapy and LEEP are two safe, effective, and relatively simple and inexpen- sive outpatient methods used for the treatment of precancer. e major practical difference between the two methods is that LEEP involves excision of the tissue and hence provides a tissue specimen that allows for histological verification of the diagnosis. On the other hand, cryotherapy is an ablative method that involves destroying the tissue and thereby leaves no sample for histology (see Table 1.3). Regardless of which outpatient method is used, health care providers should be aware of the implications of treating women living in areas where HIV prevalence rates are high (see box on next page). Use of less-invasive methods requires less infrastructural support, can minimize women’s health risks, and decreases health care costs. Simpler methods oen are more accessible to women because they can be offered at lower levels within the health care system. 10 Part One: Background 1 11Chapter 1: Rationale for Cervical Cancer Prevention 1HIV-Specific Treatment Issues Precancerous cervical lesions tend to be more prevalent, persistent, and likely to recur in HIV-positive women (Ellerbrock et al. 2003, Tate and Anderson 2002). erefore, these women should receive special counseling prior to treatment. Women should be advised that cryotherapy and LEEP are likely to be less effective in treating lesions in HIV-positive women and that they will need regular follow-up care. ere is some evidence that HIV shedding increases substantially—but temporarily—from the treated area of the cervix following treatment (Wright et al. 2001). Currently there is no conclusive evidence linking HIV transmission with cryotherapy or LEEP; this needs further evaluation. For women requiring treatment, it is essential to counsel the client and her partner on the importance of abstaining from sexual intercourse during the healing period (or using a condom if abstinence is not possible) to protect the woman and her partner from possible increased risk of HIV infection. Cryotherapy Cryotherapy is a relatively simple procedure that destroys precancerous cells by freezing the cervix, using compressed carbon dioxide (CO 2 ) or nitrous oxide (N 2 O) gas as the coolant. To freeze the lesion, the cryoprobe is placed on the cervix, ensuring that the probe covers the entire lesion. e aim of this procedure is to create an ice ball extending 4–5 mm beyond the lateral margin of the cryoprobe. Cryotherapy is performed using a single-freeze or double-freeze technique. Single freeze involves freezing for three minutes; double freeze involves freezing for three minutes followed by a thaw for five minutes, and then a second freeze for three minutes. e ACCP is conducting a randomized control study comparing single with double freeze to clarify the implications and potential advantages and disad- vantages of each; results will be available in early 2005. Cryotherapy is an outpatient procedure that can be performed easily and quickly (in 15 minutes or less) without anesthesia. It can be safely and effectively performed by general practitioners and non-physicians (Jacobs et al. forthcoming). ACCP studies show that cryotherapy is an acceptable treatment option for women, their partners, and providers (Royal ai College of Obstetricians and Gynecologists [RTCOG]/JHPIEGO 2003a). Women undergoing cryotherapy need clear information and support to alleviate possible anxieties about side effects. Many women experience mild discomfort, such as pain or cramping during or within two to three days aer the procedure. ey may also experience dizziness, fainting, or flushing during or immediately aer treatment. e most frequently experienced side effect of cryotherapy is a profuse, watery vaginal discharge for up to four weeks. Although inconvenient, women can effectively manage it by using a clean cloth or sanitary pads to protect clothing. Complications associated with cryotherapy are minimal. Available data suggest that cryotherapy is safe, with very little risk of major complications (ACCP 2003a). Severe bleeding and pelvic inflammatory disease, two of the most serious 10 Part One: Background 1 11Chapter 1: Rationale for Cervical Cancer Prevention 1 potential complications, are extremely rare in women treated with cryotherapy. ere also is no evidence that cryotherapy is linked to cervical stenosis or has any long-term impact on women’s fertility or pregnancy outcomes—important con- siderations when treating women of reproductive age (ACCP 2003a, RTCOG/ JHPIEGO 2003b). Cryotherapy is the most practical treatment approach for most low-resource settings given its simplicity and low cost. In addition, it can be safely performed in primary care settings by non-physicians; so in settings where screening test results are immediately available, women can be treated during the same visit. Other advantages of cryotherapy are that the equipment required is relatively simple, the procedure is easily learned, and it does not require anesthesia or a power supply. One disadvantage of cryotherapy is that because it destroys the tissue, no tissue sample is available to confirm that the entire lesion has been removed. Furthermore, it is not possible to establish whether it is an early invasive lesion requiring further treatment. Cryotherapy is not appropriate for treating large lesions that cannot be covered by the probe or lesions located in the endocervical canal. Also, a regular supply of liquid coolant is necessary. Loop electrosurgical excision procedure (LEEP) Sometimes referred to as large-loop excision of the transformation zone (LLETZ), LEEP utilizes a thin electric wire in the form of a loop to remove the abnormal area of the cervix. e procedure is usually done using colposcopic guidance under local anesthesia in a secondary or tertiary care setting and requires local anesthesia, as well as a continuous power supply. Severe bleeding is a possible complication both during and aer the procedure, occurring in 1% to 4% of patients (Mitchell 1998, Wright et al. 1992, Sellors and Sankaranarayanan 2002). More sophisticated equipment is required compared with cryotherapy. Table 1.3 compares cryother- apy and LEEP on key criteria. Two advantages of LEEP are that it is a simple surgical procedure and that the excised tissue can be sent for histopathological confirmation, which allows the exact nature of the lesion to be determined and unsuspected microinvasions to be detected. However, many developing countries lack access to histology services. 12 Part One: Background 1 13Chapter 1: Rationale for Cervical Cancer Prevention 1 TABLE 1.3. Comparison of cryotherapy and LEEP Indicators Cryotherapy LEEP Effectiveness 86–95%* 91–98%* Potential side effects Watery discharge Bleeding Anesthesia None required Local anesthesia necessary Tissue sample for histopathology No Yes Power required No Yes Relative cost Low High Level of provider Physicians and non- physicians Mostly by physicians Source: Adapted from Bishop 1995. *ACCP 2003a, Martin-Hirsch et al. 2004. Linking screening and treatment Regardless of the screening test used, screening must be linked to treatment to ensure program effectiveness. is can be done using the traditional approach (screen, diagnose, confirm, and treat), intermediate approach (screen, diagnose, and treat with post-treatment biopsy confirmation), or the screen-and-treat approach (treatment is based on the results of screening test alone). ese approaches are described in detail in Chapter 6. Justification for Cervical Cancer Screening e purpose of any type of public health screening is to offer a low-cost, accessible means for determining who in a population is likely to have or develop a certain disease, and to then provide diagnostic testing, appropriate treatment, or both. e general principles of public health screening are described in the box opposite. 12 Part One: Background 1 13Chapter 1: Rationale for Cervical Cancer Prevention 1General Principles of Screening Criteria for deciding whether or not screening is appropriate include: • Is the disease a public health problem? • Is the natural history of the disease understood? • Is there a recognizable latent or early symptomatic stage? • Is there an acceptable treatment for the disease? • Is there consensus on whom to treat? • Are facilities for screening and treatment available and accessible? • Is there an economic balance between case finding and subsequent medical care? • Is the program sustainable? Source: Adapted from PATH 2000. Cervical cancer screening is justified according to the listed criteria because: • Cervical cancer is an important public health problem in many resource-poor settings. • ere is a recognized precursor stage (i.e., precancerous lesions) that can be treated in a safe, effective, and acceptable way. • e time between the appearance of precancerous lesions and the occur- rence of cancer is long (about ten years), leaving ample time for detec- tion and treatment. • Treatment of early lesions is very inexpensive compared to the man- agement of invasive cancer. Women who have access to effective prevention programs are less likely to develop cervical cancer than women who do not. It is not surprising then that the inci- dence of cervical cancer varies dramatically between regions of the world, as well as between different socio-demographic groups within a given region. In the mid- 1980s, approximately 40% to 50% of women in developed countries had been screened in the preceding five years, compared to only 5% of women in developing countries (WHO 1986). Although these data are old, there are few indications that the situation has changed significantly since then in most developing countries. For example, more recently, only 8% of more than 20,000 South African women 20 years of age and older reported having had a Pap smear in the preceding five years (Fonn et al. 2002). Likewise, in a rural district in India, where more than 120,000 women were interviewed, less than 1% reported having ever been screened. In developed countries where women regularly receive cytologic screening, programs have led to decreased cervical cancer-related mortality (Mitchell et al. 1996, Eddy 1990, IARC 1986a,b). In most developing regions, however, cervical cancer mor- tality rates have not declined substantially despite attempts to establish screening programs (Beral et al. 1994). 14 Part One: Background 1 15Chapter 1: Rationale for Cervical Cancer Prevention 1 Conclusion Cervical cancer is preventable through screening to detect precancerous lesions and appropriate treatment before the lesions develop into cancer. e nature of the disease and the treatment options available justify cervical cancer screening programs, according to general principles of public health screening. Various cervical cancer screening, diagnostic, and treatment methods are currently being used in developed and developing countries. Each method has strengths and limita- tions that need to be considered in the policy-level decisions about which methods to use. It is important to remember that regardless of the screening and treatment methods chosen, the two must be strongly linked so that women who are identified as having precancerous lesions are able to get the treatment they need to prevent the development of cancer. Further Reading Alliance for Cervical Cancer Prevention (ACCP). e Case for Investing in Cervical Cancer Prevention. Seattle: ACCP; 2004[a]. Cervical Cancer Prevention Issues in Depth, No. 3. ACCP. Effectiveness, Safety, and Acceptability of Cryotherapy: A Systematic Literature Review. Seattle: ACCP; 2003[a]. Cervical Cancer Prevention Issues In Depth, No. 1. American College of Obstetrics and Gynecology (ACOG). ACOG statement of policy, March 2004: cervical cancer prevention in low resource settings. Obstetrics and Gynecology. 2004;103(3):607–609. International Agency for Research on Cancer (IARC) Working Group on the Evaluation of Cancer-Preventive Strategies. Cervix Cancer Screening. Lyon, France: IARCPress. IARC Handbooks of Cancer Prevention, Vol. 10 [forthcoming]. Sellors JW, Sankaranarayanan R. Colposcopy and Treatment of Cervical Intraepithelial Neoplasia: A Beginners’ Manual. Lyon, France: IARCPress; 2002. World Health Organization (WHO). Comprehensive Cervical Cancer Control: A Guide for Essential Practice. Geneva: WHO [forthcoming]. WHO. Cytological Screening in the Control of Cervical Cancer: Technical Guidelines. Geneva: WHO; 1988. WHO. National Cancer Control: Programmes, Policies, and Managerial Guidelines. 2nd ed. Geneva: WHO; 2002[a]. Wright TC, Richart RM, Ferenczy A. Electrosurgery for HPV-Related Diseases of the Lower Genital Tract: A Practical Handbook for Diagnosis and Treatment by Loop Electrosurgical Excision and Fulgaration Procedures. Quebec, Canada: Arthur Vision Incorporated; 1992. 14 Part One: Background 1 15Chapter 1: Rationale for Cervical Cancer Prevention 1 Ap pe nd ix 1 .1 . C ha ra ct er ist ics o f S cr ee ni ng Te st s Ch ar ac te ris tic s Ce rv ic al cy to lo gy Ne w er sc re en in g te st s HP V DN A te st Vi su al in sp ec tio n te st s Vi su al in sp ec tio n w ith a ce tic a ci d (V IA )* Vi su al in sp ec tio n w ith Lu go l’s io di ne (V IL I) Se ns iti vi ty a nd sp ec i- fic ity fo r h ig h- gr ad e le sio ns a nd in va siv e ca nc er s Se ns it iv it y = 4 7– 62 % ** Sp ec ifi ci ty = 6 0– 95 % ** C yt ol og y ha s be en a ss es se d ov er th e la st 5 0 ye ar s in a w id e ra ng e of s et ti ng s in b ot h de ve lo pe d an d de ve lo pi ng co un tr ie s. Se ns it iv it y = 6 6– 10 0% ** Sp ec ifi ci ty = 6 2– 96 % ** H PV D N A te st in g ha s be en as se ss ed o ve r th e la st d ec ad e in m an y se tt in gs in d ev el op ed c ou n- tr ie s an d re la ti ve ly fe w s et ti ng s in de ve lo pi ng c ou nt ri es . Se ns it iv it y = 6 7– 79 % ** Sp ec ifi ci ty = 4 9– 86 % ** V IA te st in g ha s be en a ss es se d ov er th e la st d ec ad e in m an y se tt in gs in d ev el op in g co un tr ie s. Se ns it iv it y = 7 8– 98 % ** Sp ec ifi ci ty = 7 3– 91 % ** V IL I t es ti ng h as b ee n as se ss ed b y IA R C ov er th e pa st 3 y ea rs in In di a an d 3 co un tr ie s in A fr ic a. It n ee ds to b e ev al u- at ed b y ot he rs in a dd it io na l s et ti ng s to co nfi rm th e re pr od uc ib ili ty o f t he a bo ve re su lts . Nu m be r o f v isi ts re qu ire d fo r s cr ee ni ng an d tr ea tm en t R eq ui re s 2 or m or e vi si ts . R eq ui re s 2 or m or e vi si ts . C an b e us ed in a s in gl e- vi si t ap pr oa ch in s et ti ng w he re o ut pa - ti en t t re at m en t i s av ai la bl e. C an b e us ed in a s in gl e- vi si t a pp ro ac h in s et ti ng w he re o ut pa ti en t t re at m en t i s av ai la bl e. *V IA is a ls o re fe rr ed t o as d ir ec t vi su al in sp ec ti on ( D V I) . ** S ou rc e: S an ka ra n ar ay an an e t al . f or th co m in g. S en si ti vi ty i s th e pr op or ti on o f in di vi du al s co rr ec tl y id en ti fi ed b y th e te st a s ha vi n g di se as e. H ig he r se n si ti vi ty m ea n s th at f ew er le si on s w il l be m is se d (i .e ., th er e w il l b e fe w er fa ls e n eg at iv es ). S pe ci fic it y is t he p ro p or ti on o f i n di vi du al s co rr ec tl y id en ti fi ed b y th e te st a s N O T h av in g di se as e. H ig he r sp ec ifi ci ty m ea n s th at t he re w il l b e fe w er f al se p os it iv es . 16 Part One: Background 1 17Chapter 1: Rationale for Cervical Cancer Prevention 1 Ch ar ac te ris tic s Ce rv ic al cy to lo gy Ne w er sc re en in g te st s HP V DN A te st Vi su al in sp ec tio n te st s Vi su al in sp ec tio n w ith a ce tic a ci d (V IA )* Vi su al in sp ec tio n w ith Lu go l’s io di ne (V IL I) Ty pe o f p ro vi de r C om pe te nt ly tr ai ne d nu rs e, n ur se m id w ife , c lin ic al a ss is ta nt , p hy si ci an ’s as si st an t, ge ne ra l p hy si ci an , o r gy ne - co lo gi st to o bt ai n an d fix th e sp ec im en . C om pe te nt ly tr ai ne d la b te ch ni ci an to pr oc es s an d ev al ua te th e sp ec im en . C om pe te nt ly tr ai ne d nu rs e, n ur se m id w ife , c lin ic al a ss is ta nt , p hy - si ci an ’s as si st an t, ge ne ra l p hy si - ci an , o r gy ne co lo gi st to c ol le ct th e sa m pl e. C om pe te nt ly tr ai ne d la b te ch ni ci an to p ro ce ss th e sp ec im en . C om pe te nt ly tr ai ne d nu rs e, n ur se m id w ife , c lin ic al a ss is ta nt , p hy si - ci an ’s as si st an t, ge ne ra l p hy si ci an , or g yn ec ol og is t t o pe rf or m a nd in te rp re t t he te st . C om pe te nt ly tr ai ne d nu rs e, n ur se m id w ife , c lin ic al a ss is ta nt , p hy si ci an ’s as si st an t, ge ne ra l p hy si ci an , o r gy ne co l- og is t t o pe rf or m a nd in te rp re t t he te st . St re ng th s W id el y ac ce pt ed a nd u se d fo r ov er 5 0 ye ar s, w it h ev id en ce th at r ed uc ti on in ce rv ic al c an ce r in ci de nc e an d m or - ta lit y ca n be a ch ie ve d in h ig h- qu al it y pr og ra m s. In s et ti ng s w it h ad eq ua te r es ou rc es , m ee ts m os t o f t he c ri te ri a fo r a go od sc re en in g te st . Pe rm an en t r ec or d of th e te st in th e fo rm o f a s lid e. H ig h sp ec ifi ci ty . Te st d et ec ts 1 3 on co ge ni c H PV ty pe s (w it ho ut d is ti ng ui sh in g w hi ch ty pe [s ] ar e pr es en t) . O bj ec ti ve te st . Id en ti fie s bo th w om en w it h pr e- cu rs or le si on s an d w om en w ho ar e at a g re at er r is k fo r de ve lo pi ng ce rv ic al d is ea se in th e fu tu re . A n eg at iv e te st r es ul t v ir tu al ly gu ar an te es th at th er e is n o H PV in fe ct io n or r el at ed le si on s. N ot a ffe ct ed b y pr es en ce o f c er vi ca l or v ag in al in fe ct io ns . H ig h sp ec ifi ci ty in w om en o ve r ag e 35 . Si m pl e pr oc ed ur e ne ed in g m in im al r es ou rc es . Im m ed ia te r es ul ts , s o im m ed ia te tr ea tm en t i s po ss ib le . Si m pl e eq ui pm en t a nd s up pl ie s ne ed ed . Si m pl e pr oc ed ur e ne ed in g m in im al re so ur ce s. Im m ed ia te r es ul ts , s o im m ed ia te tr ea t- m en t i s po ss ib le . Si m pl e eq ui pm en t a nd s up pl ie s ne ed ed . Ea si er to d et ec t c ol or c ha ng es p ro du ce d by io di ne s ta in in g th an b y ac et ic a ci d. *V IA is a ls o re fe rr ed t o as d ir ec t vi su al in sp ec ti on ( D V I) . 16 Part One: Background 1 17Chapter 1: Rationale for Cervical Cancer Prevention 1 Ch ar ac te ris tic s Ce rv ic al cy to lo gy Ne w er sc re en in g te st s HP V DN A te st Vi su al in sp ec tio n te st s Vi su al in sp ec tio n w ith a ce tic a ci d (V IA )* Vi su al in sp ec tio n w ith Lu go l’s io di ne (V IL I) Li m ita tio ns Su bj ec ti ve te st b ec au se o ut co m e de pe nd s on th e te ch ni ci an ’s in te rp re - ta ti on o f t he r es ul ts . Sy st em s ar e ne ed ed to e ns ur e th at la b re su lts a re r et ur ne d to th e cl in ic a nd th at w om en w it h ab no rm al fi nd in gs re ce iv e ap pr op ri at e tr ea tm en t. Si gn ifi ca nt in fr as tr uc tu re r eq ui re - m en ts a nd c os ts , i nc lu di ng tr ai ne d la b te ch ni ci an s. Po te nt ia l f or m is la be lin g of s am pl es an d da m ag e or lo ss d ur in g tr an sp or t. Sa m pl in g an d la b er ro rs c an o cc ur . R eq ui re s a la b qu al it y as su ra nc e sy st em . Sy st em s ar e ne ed ed to e ns ur e th at la b re su lts a re r et ur ne d to th e cl in ic a nd th at w om en w it h po si ti ve te st r es ul ts r ec ei ve a pp ro - pr ia te tr ea tm en t. Si gn ifi ca nt in fr as tr uc tu re re qu ir em en ts a nd c os ts , i nc lu d- in g tr ai ne d la b te ch ni ci an s. Po te nt ia l f or m is la be lin g of sa m pl es , l ab e rr or s, d am ag e or lo ss d ur in g tr an sp or t, an d br ea k- do w n of p ro ce ss in g eq ui pm en t. O nl y m od er at el y sp ec ifi c in w om en y ou ng er th an a ge 3 5. If tr ea tm en t i s pr ov id ed b as ed o n te st r es ul ts a lo ne , m an y w om en ar e tr ea te d un ne ce ss ar ily b ec au se th ey te st p os it iv e bu t d o no t ac tu al ly h av e pr ec an ce r. is c an ov er lo ad th e se rv ic e si te w he re tr ea tm en t i s be in g off er ed . Su bj ec ti ve te st b ec au se th e ou tc om e de pe nd s on th e cl in i- ci an ’s in te rp re ta ti on o f w ha t i s se en o n th e ce rv ix . N ot a pp ro pr ia te fo r sc re en in g po st -m en op au sa l w om en . V IA -p os it iv e le si on s ar e no t un iq ue to p re ca nc er . If tr ea tm en t i s pr ov id ed b as ed on te st r es ul ts a lo ne , m an y w om en a re tr ea te d un ne ce ss ar - ily b ec au se th ey te st p os it iv e bu t do n ot a ct ua lly h av e pr ec an ce r. is c an o ve rl oa d th e se rv ic e si te w he re tr ea tm en t i s be in g off er ed . Su bj ec ti ve te st b ec au se th e ou tc om e de pe nd s on th e cl in ic ia n’ s in te rp re ta ti on o f w ha t i s se en o n th e ce rv ix . Li m ite d da ta o n va lid it y of V IL I a s a pr im ar y sc re en in g te st . N ee ds fu rt he r ev al ua ti on . St ai ni ng c an p er si st fo r 30 to 4 5 m in ut es . er ef or e, fu rt he r cl in ic al ev al ua ti on , i f n ee de d, is d el ay ed . V IL I- po si ti ve le si on s ar e no t u ni qu e to pr ec an ce r. N ot a pp ro pr ia te fo r sc re en in g po st - m en op au sa l w om en . If tr ea tm en t i s pr ov id ed b as ed o n te st re su lts a lo ne , m an y w om en a re tr ea te d un ne ce ss ar ily b ec au se th ey te st po si ti ve b ut d o no t a ct ua lly h av e pr e- ca nc er . is c an o ve rl oa d th e se rv ic e si te w he re tr ea tm en t i s be in g off er ed . *V IA is a ls o re fe rr ed t o as d ir ec t vi su al in sp ec ti on ( D V I) . 18 Part One: Background 2 19Chapter 2: Overview of Policy Considerations 2 Overview of Policy Considerations Contents Key Messages . 19 Introduction . 19 The Decision to Develop a Cervical Cancer Prevention Program . 19 Strategic Approach Framework . 20 Policy Decisions Concerning Services . 23 Screening and treatment methods Target age group, frequency of screening, and coverage Maximizing access to health care providers Vertical versus integrated programs Conclusion. 28 Further Reading . 28 2 C H A P T E R 18 Part One: Background 2 19Chapter 2: Overview of Policy Considerations 2 Key Messages • Effective cervical cancer prevention programs can be implemented in both developed and developing countries. • Policymakers must be committed to invest in and devote the neces- sary resources and dedicated staff to program planning, implementa- tion, and monitoring. • e policy phase should be as participatory as possible, involving key stakeholders and clearly basing policy decisions on the needs and health priorities of the population. • Cervical cancer screening policies in limited-resource settings should focus on initially screening a high proportion of women in their 30s and 40s at least once using a screening and treatment approach that involves a minimal number of visits. Introduction According to the WHO managerial guidelines for National Cancer Control Programmes, the key phases in developing a cervical cancer prevention program are policymaking, program planning, and implementation. is manual focuses on the program planning and implementation phase at the subnational level (regional/district/state/provincial) and assumes that policy-level decisions are largely determined before the management team is asked to plan and implement services. Although the management team may not be involved in national-level policy decisions, they must be aware of and understand the policies about the screening and treatment methods to be used; target age group, frequency of screen- ing, and desired population coverage level; maximizing access to health care pro- viders; and vertical or integrated services. The Decision to Develop a Cervical Cancer Prevention Program e natural history of cervical cancer and the availability of effective screening and treatment methods justify, in principle, investment in cervical cancer prevention programs. ACCP research findings suggest that it is possible in developing coun- tries to implement organized cervical cancer prevention programs that will reduce the burden of disease. However, it is not recommended that screening programs be put into place in any setting unless two conditions are met. First, the incidence of cervical cancer must justify it. Second, the necessary resources must be available and committed for attaining wide screening coverage and ensuring that adequate systems are in place to appropriately manage screen-positive women, in order to achieve program success (WHO 2002a). erefore, primary policy decisions are whether a cervical cancer prevention program is justified in the given setting and if there is political commitment to dedicate the necessary resources to effectively plan, implement, and monitor such a program. 20 Part One: Background 2 21Chapter 2: Overview of Policy Considerations 2 Selecting appropriate technologies for screening and treating precancer are just the start of a successful program. e resources and requirements for making screening and treatment available and accessible, as well as the willingness and ability of women to use the services, play equally important roles. Implementing an organized screening program that addresses these issues is the best way to ensure success. Ideally, an organized screening program should have a population-based cancer registry and a computerized call and recall system, both of which may not be feasible in limited-resource settings. However, a well-managed screening program with coordinated services based on the key characteristics listed in the box below is feasible even in limited-resource settings. Characteristics of Organized Screening Programs An organized cervical cancer screening program has: • A defined target population. • Effective recruitment strategies to achieve high coverage. • A health care system with capacity to screen, follow-up on those screened positive, and provide treatment as indicated. • A quality assurance system. • A health information system. • A management team responsible for planning and implementation. Source: Quality Management Working Group, Cervical Cancer Prevention Network 1998. Opportunistic, or spontaneous, screening refers to services provided to women who request it or who are already in a health facility for other services, without any effort to reach a particular population. is has less impact on cervical cancer incidence and mortality and reduces cost-effectiveness (Hakama 1997). A major problem with opportunistic screening is that many of the women who are screened are not in the appropriate age group, since most of the screening is limited to women attending primary health care, antenatal, and family planning clinics. Oen in these settings many of the women are less than 30 years old and are not likely to show signs of precancer or have low-grade disease which will regress spontaneously. ere are few organized efforts in low-resource settings to ensure that women over the age of 30 are screened (Chirenje et al. 2001, Miller 1992). Consequently, women are not identified until they are at an advanced stage of disease, resulting in high mor- bidity and mortality (Parkin et al. 1993). Strategic Approach Framework WHO’s strategic approach to the introduction of contraceptive technologies (Simmons et al. 1997) can be adapted to the introduction or strengthening of cervical cancer prevention programs. is approach promotes the concept that appropriate decisions concerning policy and program development should be 20 Part One: Background 2 21Chapter 2: Overview of Policy Considerations 2 based on an understanding of the relationships between the at-risk population, the service delivery system, and the mix of services and interventions being provided. e process also takes into account how these interactions are infl uenced by the broader sociocultural and political context. is locally led process of program design encourages collaboration and partnership among a broad range of stake- holders concerned about improving the quality of current services or introducing new technologies. In adapting this strategic approach to the introduction of cervical cancer preven- tion services, it is recommended that policy-level decisions and planning should address a series of interactions between: • Women (clients) and the services that are available and accessible to them. • Women and the screening and treatment technologies, including how acceptable women fi nd the available options. • Service delivery systems and the screening and treatment technologies, including the ability to successfully introduce new technologies and sustain the services. (See Figure 2.1 below and box on page 22.) FIGURE 2.1. A strategic approach to cervical cancer prevention Women’s perspectives Medical profi le Sociocultural and gender infl uences Community outreach Education W O M E N Policies, program structure, management Availability and accessibility Quality of services Health Information Systems Referrals Qualifi ed providers Effi cacy Safety Procedures and supplies Laboratories (including quality control) Costs Acceptability S E R V I C E T E C H N O LO G Y Source: Adapted from Simmons et al. 1997. 22 Part One: Background 2 23Chapter 2: Overview of Policy Considerations 2 Strategic Approach to Assessing Cervical Cancer Prevention Programs in Bolivia e WHO’s three-stage Strategic Approach for the Introduction of Contraceptive Technology (Simmons et al. 1997) fosters the participation of local decision-makers, communities, and stakeholders in developing and implementing a strategy for providing and utilizing services. From 2001 to 2002, in an effort to assess the existing cervical cancer prevention and treatment services in Bolivia and to identify appropriate intervention strategies, the Component for the Detection and Control of Women’s Cancer of the Bolivian Ministry of Health adapted and initiated the WHO strategic approach. In collaboration with EngenderHealth and PAHO, the ministry instituted the first of the three stages by conducting a situation analysis in four regions of Bolivia. A multidisciplinary team, conducted the situation analysis using semi-structured interviews and observations. A technical workshop was then organized with key stakeholders and together the group developed evidence-based priorities and recommendations to improve services, including future research opportunities, policies, and programmatic interventions. Multidisciplinary involvement enabled the incorporation of many perspectives and encouraged in-country alliances to reinforce and expand ideas for program planning and policy development. is participatory process led to stakeholder ownership of the assessment findings and recommendations in Bolivia. Source: Bolivia Ministry of Health et al. 2003. 22 Part One: Background 2 23Chapter 2: Overview of Policy Considerations 2 Policy Decisions Concerning Services As described in the box that starts below, the policy phase of program development consists of the following steps: confirm political commitment, engage high-level stakeholders, conduct a large-scale situation analysis, develop policies based on the assessed situation, and obtain support for the new policies and resources for programming. While the entire management team is not usually involved in the policy development, it is helpful for the team to understand some of the factors that are considered in policymaking, particularly those decisions that most directly affect service delivery and program management. Steps in the Policy Phase of Program Development Confirm political commitment High-level decision-makers must be committed to developing or strengthening a cervical cancer program. is commitment must be reflected in the investment of the necessary resources and designation of a coordinator for cervical cancer prevention with appropriate mandate, authority, and resources to direct the program. Engage high-level stakeholders Policymakers need to identify senior individuals representing the key groups that will be involved in or affected by a cervical cancer prevention program to provide guidance and support for program development. Such individuals should be decision-makers within their own organizations, and should include senior Ministry of Health officials, heads of medical organizations, university professors, heads of nongovernmental organizations (NGOs), and high profile community leaders, particularly representing women’s groups. Conduct situation analysis To make decisions about the feasibility and scope of the program, the burden of disease in the population must be determined and the relative importance of cervical cancer compared to other health priorities must be assessed. Existing services that could be utilized for a screening program must be surveyed, and technical resources that are currently available (or can realistically be developed) need to be identified. Develop policy e policies that will govern the services must be determined. ese policies should establish the screening and treatment methods to be used, the target age group for screening, the desired population coverage, screening frequency, appropriate provider licensing (e.g., permitting mid- level health providers to perform clinical procedures), and whether the program will be vertical or integrated into other health services. ese decisions are made at the national policy level because they require large-scale commitment, support, and allocation of resources. National guidelines and norms should be developed based on these policies. Ü 24 Part One: Background 2 25Chapter 2: Overview of Policy Considerations 2 Obtain support for new policy and solicit resources for the program Resources must be allocated to ensure the program can be adequately implemented. Support from managerial and medical bodies also must be obtained so that they advocate for the new policies and programming within their own spheres of influence. Source: Adapted from WHO 2002a. Screening and treatment methods ose responsible for making decisions about what screening and treatment options will be implemented in any country, program, or organization should consider the following when deciding which are most suitable: • Performance of the screening tests. • Processing requirements of the tests. • Safety and effectiveness of the treatment. • Equipment and supplies required. • Feasibility of using the screening and treatment options in proposed locations. • Acceptability of screening and treatment options to women, their partners, and providers. • Likely impact of the screening and treatment options on the burden of disease. • Costs involved. Target age group, frequency of screening, and coverage Target age group When determining the target age group for screeningthe most appropriate ages to initiate and to stop screeningthe following should be taken into consideration: • e risk of the disease in various age groups. • e performance characteristics of the screening tests to be used with respect to various age ranges. • e availability of resources needed to provide screening and treatment. 24 Part One: Background 2 25Chapter 2: Overview of Policy Considerations 2 According to IARC (IARC Handbooks of Cancer Prevention, Volume 10, forth- coming) screening should initially focus on women in their 30s and 40sthe ages where women are at the highest risk of precancerous lesions but before the incidence of invasive cancer begins to peak. In most countries, the incidence of invasive cervical cancer is very low among women under age 25. Generally, inci- dence increases thereaer and reaches a maximum in women in their 50s and 60s. Data from cancer registries in developing countries indicate that approximately 70% of confirmed cases occur among women aged 45 or older. Precancerous lesions, however, are generally detectable for ten years or more before cancer develops, with a peak at about age 35. Women over 50 who have never been screened are at relatively high risk of cervical cancer, though women in this age group who have had one or more negative screens in the last ten years are at low risk. e specific characteristics of different screening tests can help determine the target age group. For example, visual screening methods are most suitable for women under the age of 50, because in older women the squamocolumnar junction recedes into the cervical canal and is difficult to see. HPV DNA testing should be restricted to women over 35 years. In younger women HPV DNA testing has low specific- ity and therefore produces a high rate of false positive test results (Wright and Schiffman 2003). Cytology is appropriate for all ages, although for older women, instruments that allow sampling of endocervical cells are recommended. Screening frequency As noted, cervical cancer generally develops slowly from precursor lesions. erefore, screening can take place relatively infrequently and still have a signifi- cant impact on reducing cervical cancer morbidity and mortality. Based on the ACCP’s mathematical modeling studies using observed data (prospective cohort studies, databases, and published literature), if resources permit only once-per- lifetime screening, then the focus should be to screen women in the 30s and 40s, especially women between 35 and 40 years. If resources allow screening two or three times per lifetime (rescreening), the optimal interval should be every five years (not every ten years); for example, screening at ages 35, 40, and 45 is better than screening at ages 30, 40, and 50 (Goldhaber-Fiebert et al. 2003, Goldie and ACCP 2004, personal communication with S. Goldie, May 2004). If resources permit more frequent screening, however, then screening can be once every three years from age 25 to 49 and then every five years to the age of 64 (IARC forthcoming). Screening coverage Coverage refers to the extent of participation of eligible (i.e., target age) women in the screening program in a given time period and is calculated by dividing the number of eligible women screened during a given time by the total number of eligible women. High coverage of the target population is one of the most impor- tant components of a successful cervical cancer prevention program (Pretorius et al. 1991, Sasieni 1991, WHO 1992). Evidence from some countries where screening programs are in place shows that more than 50% of women diagnosed with cervical cancer have never been screened (Sung et al. 2000). Since most cervical cancer occurs in unscreened women, reaching them with prevention services will have the greatest impact in reducing the incidence of and mortality from cervical cancer. Unnecessarily rescreening women and routinely screening those outside the target age group (e.g., 20-year-old 26 Part One: Background 2 27Chapter 2: Overview of Policy Considerations 2 women attending clinics for prenatal care) can result in substantially higher costs with minimal population benefits. Increasing coverage is generally more important than marginal increases in the frequency of screening (Miller 1992, Sasieni 1991)— or even small increases in the sensitivity of the screening test (Kim et al. 2002a, Kim et al. 2002b)—particularly for countries with low screening coverage (e.g., below 25%). Based on this evidence, the program’s coverage objectives should be to focus on screening women in the target age group and to avoid repeatedly screening women who have already been screened in the recent time period. Once coverage goals are set, the management team must apply them to the pop- ulation in their own catchment area. is is addressed in Chapter 5. If national coverage goals have not been set, a key step in program planning would be to set such goals for the local area. Maximizing access to health care providers e ACCP has found that a wide range of competently trained medical personnel, both physicians and non-physicians, can provide cervical cancer screening and treatment. e decision regarding who can perform specific procedures should be based on national norms and regulations. If norms and guidelines are unnecessar- ily restrictive, decisions should be made jointly with the relevant in-country pro- fessional organizations or licensing bodies to revise the norms and guidelines. Vertical versus integrated programs In vertical programs, health care providers and facilities are devoted to only one health care service. A fully integrated program involves integration of all aspects of programming: planning and budgeting, organizational structure, staff roles and responsibilities, training, supervision, logistics, information systems, monitoring, and clients’ access to services (Management Sciences for Health 1994). In integrated programs, clients can access more than one health service at the same facility, on the same day, and (sometimes) from the same health care provider. Many factors influence the decision on whether to integrate cervical cancer prevention programs with other health programs. ey include political commitment to integration in the existing health structure, competing health priorities, existing national policy on cervical cancer prevention, availability of personnel and material resources, requirements for a shi in resources, and donor preferences and commitment of resources. Management teams need to consider the strengths and limitations of integrated and vertical programs (see Table 2.1). Ideally, to maximize client access, programs should work toward providing integrated services to the degree that the resources and capacity allow. It is important, however, to ensure that integrated services do not result in an excessive workload for providers, which can adversely affect service delivery and the program’s effectiveness. Integrating cervical screening services will work only when services are able to reach a large group of women aged 30 and older. For example, integrating cervical cancer prevention with family planning services makes cervical cancer prevention services less likely to reach older women, because 50% to 60% of women attending family planning clinics are younger than 30 years old (Claeys et al. 2003). Regardless of whether the program is vertical or 26 Part One: Background 2 27Chapter 2: Overview of Policy Considerations 2 integrated, it is important to have a holistic approach to a client’s needs and to ensure she receives or is referred for all the services she needs to ensure her good health. Further discussion of vertical and integrated services is found in Chapter 6. TABLE 2.1. Strengths and limitations of vertical and integrated programs Vertical Program Integrated Program Strengths • Higher commitment to and focus on the cervical cancer prevention objectives. • Staff roles and responsibilities are clearly defined. • Health benefits from the oppor- tunity to deal with several health problems during the one visit. • Avoids stigma that a “cervical cancer service” might generate. • Can use an existing referral network, plus benefit from on-site referrals. • Wider range of staff available. Limitations • Higher cost for the health system (since facilities and equipment are not shared). • Logistical and cost burden to the client (cost of transport, work, and family responsibili- ties) for referrals or if she needs other health services. • Competing priorities (preven- tion seen as less urgent than treatment). • Higher level of planning and organization required. • Has the potential to excessively increase the providers’ workload. • Providers’ and supervisors’ roles and responsibilities are less well defined. 28 Part One: Background 2 Conclusion e policy phase of program development is critical because it assesses needs at a population or country level, determines policies that will guide service delivery, and develops political and financial support for programming. e policy phase should be as participatory as possible, involving key national stakeholders and clearly basing policy decisions on the needs and health priorities of the popula- tion. Understanding the factors involved in policymaking will help the manage- ment team to explain the rationale for program policies and build support at the local level for program planning and implementation. Given the necessity to commit resources for whatever strategy is chosen, cost-effec- tiveness becomes a critical consideration for policymaking. Based on the available evidence from cost-effectiveness analysis (Goldie et al. 2001, Mandelblatt et al. 2002), it is recommended that cervical cancer screening policy in limited-resource settings should: • Focus initially on screening women who are in their 30s and 40s. • Focus on a screening and treatment approach that involves a reduced number of visits (to minimize the loss to follow-up that occurs with each additional visit). • Focus on high coverage over increasing screening frequency. Further Reading American College of Obstetrics and Gynecology (ACOG). ACOG statement of policy: cervical cancer prevention in low resource settings. Obstetrics and Gynecology. 2004;103(3):607–609. Management Sciences for Health. Managing integrated services. e Family Planning Manager. 1994;3(3). International Agency for Research on Cancer (IARC) Working Group on the Evaluation of Cancer-Preventive Strategies. Cervix Cancer Screening. Lyon, France: IARCPress. IARC Handbooks of Cancer Prevention, Vol. 10 [forthcoming]. Pan American Health Organization (PAHO). A Needs Assessment Guide for a Cervical Cancer Prevention and Control Program. Washington, DC: PAHO; 2002[a]. Sung HY, Kearney KA, Miller M, Kinney W, Sawaya GF, Hiatt RA. Papanicolaou smear history and diagnosis of invasive cervical carcinoma among members of a large prepaid health plan. Cancer. 2000;88(10):2283-2289. World Health Organization (WHO). National Cancer Control Programmes. Policies and Managerial Guidelines. 2nd ed. Geneva: WHO; 2002[a]. Planning and Managing a Program P A R T Two Part Two of this manual provides information on how to systematically plan and manage a cervical cancer prevention and control program. e processes described can be used to design a new program or to strengthen an existing program, and can be adapted to reflect local situations and circumstances. Chapter 3 provides information on the organization and role of a team to plan an effec- tive cervical cancer prevention program. It also describes the essential compo- nents of a program, introduces the principle of quality of care, and gives details on the first step in planning. Chapter 4 describes the second step of program development—needs assessment—with sample interview questions provided in an appendix. Chapter 5 considers the remaining steps of program development: creating a program action plan, determining budget allocations, and setting up systems for service delivery and quality management prior to launching a program. 30 Part Two: Planning and Managing Programs 3 31Chapter 3: Initiating the Planning Process 3 Initiating the Planning Process Contents Key Messages .31 Introduction .31 Components of the Program .34 Service delivery components Three critical activities for program success Engaging Stakeholders .37 Conclusion .39 Further Reading .39 Appendix 3.1. Checklist for Planning and Implementing a Program .40 3 C H A P T E R 30 Part Two: Planning and Managing Programs 3 31Chapter 3: Initiating the Planning Process 3 Key Messages • e national cervical cancer prevention and control program coordi- nator establishes a multidisciplinary management team, and together they plan, implement, and evaluate the program. • A cervical cancer prevention and control program consists of three service delivery components that must be linked together: community information and education (I&E), screening services, and diagnostic and/or treatment services. Critical to the effectiveness of these com- ponents are training, monitoring and evaluation, and policy. • Engaging key stakeholders is crucial before starting program planning and implementation. • Defining and ensuring good-quality work processes and systems at all levels is the responsibility of the management team with assistance from the stakeholder advisory group and task groups. Introduction Systematic planning and investments in health services are required for a well- managed cervical cancer prevention and control program. In many countries, however, it has been observed that there is little accountability, planning, or atten- tion given to programmatic structure and management, rendering screening and treatment services less effective than they could be. As described in the previous chapter, planning and implementing the program is preceded by a national-level policy phase. is phase establishes the foundation for programming and includes designating a program coordinator. Before moving from the policy phase to planning the program, the coordinator should establish a management team, and together they should engage local stakeholders. Figure 3.1 illustrates the various steps in the program planning and implementation process and how they relate to the policy phase. 32 Part Two: Planning and Managing Programs 3 33Chapter 3: Initiating the Planning Process 3 FIGURE 3.1. The policy and program management process Policy Phase Planning and Implementation Phases Ministry of Health Senior Health Advisors and Stakeholders Confirm political commitment, invest resources, and designate a coordinator for a new or strengthened program. Evaluate the program for outcomes. Launch, implement, and monitor the program. Build the capacity for the program and prepare for implementation. Plan the program by engaging local stakeholders, assessing local needs, and developing a program action plan and budget. Analyze existing situation to determine feasibility to create a new or strengthened program. Engage high-level stakeholders. Modify program based on evaluation results. Develop national policies, guidelines, and norms. Obtain support for new policies and resources for programming. Program Management Team 32 Part Two: Planning and Managing Programs 3 33Chapter 3: Initiating the Planning Process 3 e program coordinator must have the appropriate mandate, authority, and resources to direct the program with the multidisciplinary management team. e team should lead the planning, implementation, and evaluation of the program. is would apply to the creation of a new program or to the strengthening of an existing program. Depending on the country’s health system, a management team would function at a national or subnational level. e principal roles of the management team are to: • Involve local stakeholders in the planning and implementation of the program. • Assess local needs for the program. • Develop a program plan and budget. • Provide overall management, budgetary, and evaluation support during program implementation. • Coordinate activities between the various program components. Members of the management team should possess the skills and expertise needed to carry out the principal roles. Sharing responsibilities will be necessary among all members of the team, as will tapping the experience and perspectives of stakeholders and community members. Forming small task groups for specific components of the program plan and its implementation is one good strategy for ensuring that the expertise of team members is strategically lev- eraged. For example, a task group may be established to oversee a local needs assessment or to oversee the development of an informa- tion system, and the task group could report back to the management team on its recommendations. One model for how a management team may operate is provided in the next box. Management teams play an essential role in program planning, implementation, and evaluation. 34 Part Two: Planning and Managing Programs 3 35Chapter 3: Initiating the Planning Process 3 A Management Team for a Cervical Cancer Prevention and Control Program A management team, headed by a program coordinator, could be com- posed of individuals with varying skills and competencies, such as: • Health administration and management. • Public health, data collection, and analysis. • Medical and clinical skills such as nursing, general medicine, gynecology, oncology, and pathology. • Laboratory management. • Community health education, social sciences. • Training. • Logistics and supplies management. A stakeholder advisory group can support the management team in program planning and ensuring quality during implementation. Stakeholder’s Advisory Group Task Group e.g., Information System Task Group e.g., Information and Education Activities Task Group e.g., Needs Assessment Management Team Components of the Program e success of a program depends not only on the screening and treatment methods, but also on the resources and requirements necessary to deliver screen- ing and treatment to a large group of women who need these services, as well as the willingness and ability of the women to avail themselves of these services. When planning a new or strengthened cervical cancer prevention program, the manage- ment team will need to consider all the necessary components of such a program. As illustrated in Figure 3.2, women’s needs and concerns should be at the center of program planning and implementation. e three main service delivery com- ponents that must be linked together—community I&E, screening services, and diagnosis and/or treatment services—are encompassed by three elements that are critical to program success and quality of care: training, monitoring and evalua- tion, and policy. 34 Part Two: Planning and Managing Programs 3 35Chapter 3: Initiating the Planning Process 3 FIGURE 3.2. Components of a cervical cancer prevention and control program Service delivery components Community information and education ese activities are necessary to inform and educate women and men in commu- nities about cervical cancer both to encourage and support women to participate in screening services and to ensure the program reaches its coverage goals. ese activities should be implemented in communities, health facilities, and through various media. Linkages must be established between the community and the health facilities. Screening services Screening services, including counseling before and a er screening, must be avail- able and accessible. All clients must be informed of their test results, and there should be effi cient tracking systems for all clients who need rescreening or referral for diagnosis and/or treatment. Where cytology or HPV DNA tests are used, lab- oratories must have the capacity to process the samples with minimal delays, use uniform reporting terminology, and have appropriate mechanisms to optimize the quality of test results. Linkages must be established and maintained through referral and feedback (counter-referral) between laboratories and the health facili- ties and between the various levels of health services. Diagnosis and/or treatment services (precancer and cancer) Cervical cancer screening services must be linked to accessible treatment for women with precancerous cervical lesions. Where prevention strategies include diagnostic and confi rmatory steps, colposcopy and biopsy services must be Policy Monitoring and Evaluation Community Information and Education Screening Services Diagnostic and/or Treatment Services Training Referral and Feedback 36 Part Two: Planning and Managing Programs 3 37Chapter 3: Initiating the Planning Process 3 available, with links between screening and diagnostic services to histopathol- ogy laboratories. In general, colposcopy and biopsy services should be available to evaluate suspected invasive lesions. Cancer management services, including surgery (or, at the very least, palliative care), should be available for women with invasive cancer. Information and counseling should be integral parts of all treat- ment services. In each of these components, the availability of trained staff, functioning equip- ment, and supplies is necessary for effective program implementation. Links between each component are necessary to ensure appropriate client management and continuity of care. Three critical activities for program success e service delivery components are supported by three activities that are essen- tial for both establishing and sustaining quality services. Policymaking Policies provide the foundation and guidelines for all aspects of the program and delivery of services. ey are usually developed at the national or subnational level and involve several essential steps (as discussed in Chapter 2). Key policy deci- sions that drive the program include the screening and treatment methods, target age group for screening, frequency of screening, the desired population coverage, the regulations permitting mid-level health providers to perform clinical proce- dures, and whether the program will be vertical or integrated into other health services. Training Training requirements are driven by reproductive health policies. Training itself is usually implemented via the institutions and structures that routinely train health workers, and it requires a commitment of resources to be sustainable. All staff involved in each component should be trained and competent in their particular roles. e knowledge, attitudes, and skills necessary to carry out their roles should be determined, and training provided or reinforced, as necessary, to ensure that the members of each staff are able to perform their roles to standard norms. is applies to outreach workers providing community I&E; to non-medical support staff at the clinic; to medical staff providing screening, diagnosis, and treatment services; to staff assigned to data collection and analysis; and to the supervisors who are responsible for ensuring performance quality. Monitoring and evaluation Monitoring and evaluation involves defining goals based on national policy, con- ducting ongoing activities to ensure that quality services are provided to enable reaching these goals, collecting and analyzing data related to these goals, and taking timely corrective action to uphold quality of care and program perfor- mance. Monitoring and evaluation should cover all service components, includ- ing laboratory service. 36 Part Two: Planning and Managing Programs 3 37Chapter 3: Initiating the Planning Process 3 Engaging Stakeholders e first step in developing a program involves engaging stakeholders to par- ticipate in the planning and management of the program. Stakeholders’ involve- ment and sense of ownership are critical for the successful implementation of the cervical cancer prevention program. To make certain that programs address women’s needs and concerns, special efforts should be made to involve women in developing, implementing, and evaluating program interventions and informa- tional messages. Table 3.2 suggests some of the recommended stakeholders. e management team should identify the individual stakeholders in their community and invite them to be involved in various aspects of program planning or implementation. Stakeholders could be invited to serve on a stakeholder advisory group or task group, or they could be invited to provide advice for specific activities, such as the design of educational materials. Quality of Care: Addressing Clients’ Rights and Providers’ Needs A quality focus in all areas of service provision is important, since the quality of the services will influence the program outcomes. erefore, attention must be given to ensuring quality in service delivery during the planning, implementation, and evaluation of the program. Two overarching principles of quality assurance are supporting clients’ rights and addressing providers’ needs. For quality services, providers need to be able to meet the clients’ rights by offering: • Complete and accurate information. • Access to services. • Informed decision-making. • Safety of services. • Privacy and confidentiality. • Dignity, comfort, and expression of opinion. • Continuity of care. e program will need to have the systems and capacity in place to support the work of the providers, which include: • Good quality management and supervisory support at the facility and district levels. • Information, training, and skills development. • Adequate supplies, equipment, and infrastructure. Sources: EngenderHealth 2004, Huezo and Carignan 1997. 38 Part Two: Planning and Managing Programs 3 39Chapter 3: Initiating the Planning Process 3 TABLE 3.2. Recommended stakeholders to involve in planning and implementing a cervical cancer prevention and control program Program components Recommended stakeholders Community information and education activities • Health facility managers. • Clinic supervisors/area managers. • Health promotion staff. • Community-based NGO representatives. • Community members. Screening services • MOH officials. • District administrators. • Health facility managers. • Clinic supervisors/area managers. • Laboratory personnel (e.g., pathologist, cytotechnician). • Representatives of medical, nursing, and allied health professions. • Procurement and supplies staff. • Purchasers (e.g., health insurance organizations). • Community members. Diagnosis and treatment services: precancer and cancer Same as above and in addition: • Colposcopy center managers. • Treatment facility managers. • Clinicians (e.g., gynecologists/gynecological oncologists/radiotherapists). • Laboratory personnel. Training • Health facility managers. • Trainers and human resource officials. • Representatives of medical colleges. • Representatives of medical, nursing, and allied health professions. • Clinic supervisors/area managers. • Laboratory personnel. • Staff representatives (doctors and nurses). • Maintenance staff. Monitoring and evaluation • District/regional/provincial information system officers. • Clinic supervisors/area managers. • Health facility managers. • Laboratory managers and cytopathologists/ cytotechnologists. • Colposcopy and treatment facility managers and clinicians. • Researchers. • Health economists. • Community members. Source: Adapted from Cervical Health Information Project (CHIP) 2004a. 38 Part Two: Planning and Managing Programs 3 39Chapter 3: Initiating the Planning Process 3 An advisory group, comprising key stakeholders at the national or subnational level, can be a useful way to support the management team in program planning and ensuring quality during implementation (CHIP 2004a). In places where health advisory committees already exist, it would be useful to suggest including cervical cancer prevention and control as a topic on their agenda. If a suitable health com- mittee does not exist, a new committee could be formed, ideally consisting of 10 to 15 members, to advise the management team and assist in overseeing program implementation and monitoring and evaluation. Conclusion Program planning should be based on the policy decisions, taking into consider- ation all the components of the program and focusing on providing quality services. e designated program coordinator working together with a multidisciplinary management team and task groups is accountable for directing the program from planning through implementation, paying particular attention to quality of care issues. e management team should identify individual stakeholders in the com- munity whose participation in advisory and task groups is crucial to the success of program planning. Further Reading EngenderHealth. Facilitative Supervision Handbook. New York: EngenderHealth; 2001. PATH. Planning Appropriate Cervical Cancer Prevention Programs. 2nd ed. Seattle: PATH; 2000. World Health Organization (WHO). National Cancer Control: Programmes, Policies, and Managerial Guidelines. 2nd ed. Geneva: WHO; 2002[a]. 40 Part Two: Planning and Managing Programs 3 41Chapter 3: Initiating the Planning Process 3 Appendix 3.1. Checklist for Planning and Implementing a Program Policy ¨ Confirm political commitment. ¨ Invest necessary resources. ¨ Designate program coordinator with mandate, authority, and resources to direct the program. ¨ Engage high-level stakeholders. ¨ Conduct situation analysis. ¨ Develop/review policies, guidelines, and norms. ¨ Evaluate screening and treatment methods and approaches. ¨ Establish target age group for screening. ¨ Determine frequency of screening. ¨ Determine desired population coverage. ¨ Establish regulations authorizing mid-level providers to perform screening and treatment. ¨ Determine whether program will be vertical or integrated. ¨ Commit/solicit resource and obtain support for the new policies. Planning the program ¨ Establish a management team. ¨ Engage local stakeholders. ¨ Assess local needs. ¨ Develop the program action plan. ¨ Determine local screening coverage goals. ¨ Establish estimates for treatment caseload. ¨ Review service delivery strategies. ¨ Develop training plan for providers. ¨ Information and education strategies ¨ Develop the budget and allocate resources according to the program action plan. 40 Part Two: Planning and Managing Programs 3 41Chapter 3: Initiating the Planning Process 3 Preparing to launch the program ¨ Establish systems for service delivery. ¨ Develop program materials. ¨ Provide orientation for community, stakeholders, and staff. ¨ Ensure provider training and availability. ¨ Procure and distribute equipment and supplies. ¨ Establish systems for quality management. ¨ Build capacity to ensure quality. ¨ Set up the system for supervision. ¨ Define the quality indicators. ¨ Set up the information system. ¨ Launch the program with an inaugural event. Implementation ¨ Provide community information and education to address community and client needs. ¨ Deliver clinical services and ensure linkages between services. ¨ Ensure performance to standards of trained providers. ¨ Monitor and supervise the work of providers to ensure quality of care. ¨ Monitor and evaluate the program performance and outcomes. ¨ Modify the program based on monitoring and evaluation results. 42 Part Two: Planning and Managing a Program 4 43Chapter 4: Assessing Program Needs 4 Assessing Program Needs Contents Key Messages .43 Introduction .43 What Needs to Be Assessed .43 Program policies, guidelines, and norms Program management issues Health services Information and education activities Community perspectives Laboratories Infrastructure, equipment, and supplies Information systems How to Conduct the Local Needs Assessment .47 Pre-assessment phase Assessment phase Post-assessment phase Conclusion .51 Further Reading .51 Appendix 4.1. Sample Questions to Assess the Use of Policies, Guidelines, and Norms .52 Appendix 4.2. Sample Questions to Assess Program Management Issues .53 Appendix 4.3. Sample Questions to Assess Health Services .54 Appendix 4.4. Sample Questions to Assess Information and Education Activities.56 Appendix 4.5. Sample Questions to Assess Community Perspectives .57 Appendix 4.6. Sample Questions to Assess a Laboratory.59 Appendix 4.7. Sample Questions to Assess Information Systems .61 4 C H A P T E R 42 Part Two: Planning and Managing a Program 4 43Chapter 4: Assessing Program Needs 4 Key Messages • A local needs assessment enables the management team to identify what inputs are required to achieve the objectives of a cervical cancer prevention and control program. • e assessment is best conducted through a participatory process involving a multidisciplinary team of stakeholders. • e categories to be assessed include adherence to program policies, guidelines, and norms; program management issues; health services; information and education (I&E) activities; the community perspec- tive; laboratories; infrastructure, equipment, and supplies; and infor- mation systems. • It is important to obtain the perspectives both of the people involved in providing and those involved in receiving services for cervical cancer prevention. Introduction A needs assessment is a process of gathering necessary and relevant information from which informed decisions can be made about planning a new or strengthened cervical cancer prevention program. It is generally the second step in a program planning cycle (the first being to engage stakeholders) and is completed prior to developing or strengthening the program. e assessment involves the develop- ment of strategic questions, followed by the systematic collection and analysis of information. e purpose is to understand the perspectives of people involved in providing or receiving services and identify gaps in services. is chapter provides guidance on how to conduct a local needs assessment as a step in developing or improving a program. What Needs to Be Assessed? e areas that should be assessed are described below. e assessment team should first define the overall strategic questions that are to be answered by the needs assess- ment (e.g., what is needed in order to screen all women in the target age group?). is will help the team to determine in which areas to focus the needs assessment and what specific questions need to be answered. Sample questions, which would be adapted by the assessment team to fit the local situation, are provided in Appendices 4.1 to 4.7. As part of the background preparation, the assessment team members should familiarize themselves with demographic information, the cervical cancer situation in their country, and the structure of health services Where there are no systems or structures in place for providing cervical cancer prevention services, the focus should be on assessing capacities described in this chapter with respect to launching new services. Obtaining feedback from key stake- holders in each area is essential to inform strategic decisions on how to effectively launch and sustain new prevention efforts. 44 Part Two: Planning and Managing a Program 4 45Chapter 4: Assessing Program Needs 4 Program policies, guidelines, and norms e consistent use of existing program policies, guidelines, and norms at the local level is important for achieving a standard of care. e policies that govern the program and delivery of services, the clinical practice guidelines for screening and treatment of precancerous lesions, and the treatment guidelines for cervical cancer all clarify health care providers’ understanding of their professional responsibili- ties. As such, the assessment team should determine the extent to which health professionals are aware of the existence of the policies and guidelines, their per- ceptions of these policies and guidelines, and the extent to which they follow them in their practice. is information can be gathered by interviewing administrators and health professionals from local health institutions. Appendix 4.1 contains sug- gested questions for interviewing administrators and health professionals. Program management issues A needs assessment must consider program management aspects in order to: • Understand how services for cervical cancer screening and treatment currently are, or could potentially be, organized and delivered. • Identify the key organizations involved in delivering these services, including potential leaders, coordinators, or area supervisors. • Define the level of available resources and assess how services could be financed. • Document the system for requesting and purchasing equipment and supplies, and for improving infrastructure. Information can be collected by interviewing key authorities in the Ministry of Health (regionally and locally); those health professionals responsible for the reproductive health program, cancer control program, or chronic disease program; presidents and program managers from cancer institutes, cancer leagues, cancer societies, and other nongovernmental organizations involved in cancer prevention; and members of medical associations, pathology associations, gynecologic asso- ciations, oncology groups, and other professional bodies. Appendix 4.2 contains sample questions. Health services e needs assessment should involve a thorough review of the local health services at the primary, secondary, and tertiary level of care within the chosen area of study (e.g., health region or municipality) to determine: • Type and scope of services currently available. • Access to health services in terms of physical access, facility conditions, and timeliness of receiving appointments and test results. • Coverage of women at risk, including the age group currently being served by screening activities, and what barriers exist to achieving high coverage. 44 Part Two: Planning and Managing a Program 4 45Chapter 4: Assessing Program Needs 4 • Client-tracking and referral mechanisms for providing test results (if applicable), for treatment, and for follow-up care, including existing linkages between the levels of care for screening, diagnosis, and treat- ment. • Acceptability of introducing new screening and treament approaches such as cryotherapy treatment delivered by mid-level providers. • Human resources and capacity, including screening and treatment services, outreach and client recruitment, counseling, and health information system (HIS) maintenance. • Infection control and instrument processing, including standards and practices currently in place. • Availability and quality of supervision and monitoring, including who currently coordinates those systems. • Linkages between services and health sectors. e health services system can be assessed by interviewing health care providers and administrators. In addition, the services themselves should be assessed by visiting and making observations of the conditions and operations. Appendix 4.3 contains sample questions for interviews with health personnel on issues related to the health services for cervical cancer screening and treatment. Information and education activities e methods and materials used to inform, educate, and meet women’s informa- tional needs for cervical cancer prevention are important for ensuring that women take up screening services as well as return for follow-up care. e needs assess- ment must therefore consider the I&E strategies that are used or could be used to reach women in the community and in the health facilities. Aspects that may be considered include strategies to communicate information, both in clinics and in the community; availability of information materials; type and purpose of information materials; accuracy, consistency, and relevance of messages; methods used to develop and test I&E materials; and methods to train health providers and community health workers (CHWs) to use the materials. Appendix 4.4 contains a list of sample questions. Community perspectives It is important to consider the perspectives of women and men in the community, their knowledge about cervical cancer, and their service needs in order to develop services that will meet their needs. Furthermore, these perspectives are impor- tant for developing promotional campaigns that address their knowledge gaps and concerns. Potential clients and their husbands (or partners) can be surveyed by CHWs or other health outreach staff who normally interact with community members. Aspects to be considered include understanding of the concept of pre- venting disease, knowledge of cervical cancer, awareness of cervical cancer pre- vention services, feelings about screening, possible barriers to utilizing screening services, and attitudes toward the health care system. Appendix 4.5 lists some sample questions. 46 Part Two: Planning and Managing a Program 4 47Chapter 4: Assessing Program Needs 4 Laboratories Laboratories that manage (or could manage) cytology, HPV DNA testing, or histo- pathology should be assessed. e objective of assessing laboratories is to evaluate their capacity, performance, workload, and needs against a generally accepted standard. It is also important to assess the availability and effectiveness of audit protocols and systems for continuing professional development. A pathologist with experience in cytology should be involved in the assessment of the laboratories and should visit and interview cytopathology laboratory directors, pathologists, technicians, and other key personnel. e assessment should include observations and documentation of the following aspects of services: • e laboratory procedures and processes including the flow of information. • e physical environment, the infrastructure, equipment, supplies, and storage capacity in the laboratory. • Availability of essential equipment and supplies needed to process the tests. • e time required from receipt of tests to sending test results back to the testing site. • Qualifications and number of technical staff available to process tests. • Procedures for processing tests. • Quality control methods used within the laboratory and external to the laboratory. • e current and potential volume of tests processed, quality of the tests received, and the quality of the test results. • e mechanisms and effectiveness of linkages for communicating results from the laboratory to the health facilities. Appendix 4.6 contains sample questions for assessing a laboratory. Infrastructure, equipment, and supplies e needs assessment should document the availability, accessibility, and adequacy of functioning equipment and supplies needed for screening and treatment services. In addition, information should be gathered on the requisition, purchasing, and distribution as well as repair and maintenance procedures for infrastructure and equipment in order to identify how these procedures may be improved. Information for this part of the needs assessment can be obtained through observations in the health centers and clinics and through interviews with clinicians and health admin- istrators. For a list of equipment and supplies recommended for a cervical cancer prevention and control program, refer to Appendix 6.1. 46 Part Two: Planning and Managing a Program 4 47Chapter 4: Assessing Program Needs 4 Information systems A cervical cancer prevention and control program requires good records, whether paper-based or computerized, to monitor the management of women in the program as well as to evaluate the program against set indicators or benchmarks. Ideally, the system should identify the number of women in the target population, record personal and clinical information on women screened, and generate lists of women with positive test results who need follow-up care. e information system could then be used to evaluate screening coverage, test quality, and the completeness of follow-up care. At a minimum, the system should collect information at the local health care site using client forms or registers. is information should then flow to referral health care sites or laboratories (if appli- cable) and to a centrally located program coordinator, who monitors women’s test results and the program’s coverage goals. erefore, the needs assessment should identify the current manner in which screening and treatment information is collected, recorded, analyzed, and moni- tored for clinical and program evaluation purposes. is activity should include determining whether this information is integrated into a national HIS or is managed separately. e assessment should note data sources, assess the forms used to record clinical and administrative information, describe the flow of forms/ information, and, if applicable, evaluate any electronic HIS being used. e assess- ment should include reviewing current forms and interviewing program managers, health administrators, laboratory personnel, and clinicians. Appendix 4.7 contains sample questions. How to Conduct the Local Needs Assessment e needs assessment should be a participatory process with three phases: a pre- assessment phase where all the preparatory work is completed, an assessment phase where new information is gathered and analyzed, and a post-assessment phase where the report is written, findings are presented to health authorities, and plans are made to implement actions that will introduce or improve screening and treatment services. Pre-assessment phase Involve local stakeholders Stakeholders should be informed about the needs assessment objectives and process. ey should also be invited to participate as part of the assessment team or to attend meetings where the assessment results are presented and subsequent plans are made for service improvements. Establish the assessment team An assessment team—a task group of the management team—should be formed to conduct all the interviews, site visits, data collection, and analysis. e assess- ment team should include representatives and stakeholders from the region, both from the public and private health sector. It is important that the team has a good 48 Part Two: Planning and Managing a Program 4 49Chapter 4: Assessing Program Needs 4 mix of technical, administrative, and communication skills. Various disciplines should be represented in the group, such as nursing, general practice, epidemiology, gynecology, pathology, sociology, health promotion, public health, and a program manager from the Ministry of Health. It is important that the team members are interested in the project and will be able to devote time to do the needs assess- ment. A designated leader for the assessment should be selected based on his or her leadership skills and abilities. e assessment team’s role is to: • Define the strategic questions to be answered in the needs assess- ment. • Assess the current state of cervical cancer prevention and control efforts within a geographically defined area. • Identify the needs and the conditions that assist or act as barriers to achieving the three goals of a program: coverage of women, quality screening test, and appropriate treatment for all screen-positive women. • Identify the specific actions and resources required for an organized screening and treatment program. Orient the team A workshop should be held with all team members to orient them to the assess- ment objectives, to ensure a common understanding of the technical issues related to cervical cancer prevention and conducting an assessment, to discuss and plan the methodology, to design the interview tools, and to plan all aspects of the process. e workshop is also useful to build teamwork and cooperation among members. Define the methodology e assessment team will review the methodological options for collecting quan- titative and qualitative information and the actual methods to be used (see Table 4.1), based on the decisions regarding the scope and extent of the needs assess- ment. Methodological options include focus group discussions, individual inter- views, mailed questionnaires, review and analysis of randomly selected clinical records within the preceding 6 to 12 months, and visiting facilities that provide services. e team will define whom to interview and select the sample of inter- viewees and health facilities from all levels of the health system in all the coverage areas. Sample questions are provided in Appendices 4.1 to 4.7. 48 Part Two: Planning and Managing a Program 4 49Chapter 4: Assessing Program Needs 4 TABLE 4.1. Methods to collect information for the needs assessment Areas to assess Collection method Policies, guidelines, and norms Review documents. Interview health administrators and health care personnel. Program management issues Interview health administrators and health care personnel. Health services Interview health care personnel. Observations in health centers. Review clinical records. I&E activities Interview health care personnel and community health workers. Community perspectives Focus groups with clients/community members. Interview clients. Survey community. Laboratories Interview laboratory personnel. Observations in laboratories. Infrastructure, equipment, and supplies Interview health administrators and health providers. Observations in health centers and clinics. Information systems Interview health administrators. Review documents. Schedule site visits Depending on the scope of the assessment, the team should make necessary trans- portation and accommodation arrangements, as well as schedule all site visits and interviews in advance. is will involve communicating and coordinating visits with health authorities and with staff at the facilities. If services are performed on specific days, efforts should be made to schedule visits accordingly. It is impor- tant to inform staff at the facilities about the need to observe procedures and the purpose of the visit, reinforcing that the visit is not to evaluate their work but to discuss their needs. It is also important to inform staff at the facility being visited that information they provide will be reported without a personal attribution. e facilities that should be visited include public-sector facilities (primary, sec- ondary, and tertiary); private-sector facilities; facilities in urban, peri-urban and rural areas (as applicable); facilities providing or having the potential to provide services for screening and treatment of precancer; laboratories (cytopathology, HPV DNA labs); and cancer management centers such as units providing radical surgery, radiotherapy, oncology, and palliative care units. 50 Part Two: Planning and Managing a Program 4 51Chapter 4: Assessing Program Needs 4 Assessment phase Collect information e assessment team should collect information as per the methodology chosen. Depending on the size of the assessment team, it may be more efficient to break into several smaller teams to collect information over a larger geographic area and subsequently pool the information. e assessment team should identify the main interviewer(s), who are selected based on their skills and abilities to conduct inter- views in a conversational and nonthreatening manner. Where possible the team should collect samples of printed material (e.g., information leaflets used) and data (e.g., clinic service data). A person should be designated to record all the findings from the site visits and interviews, using handwritten notes, tape-recorded inter- views (if feasible), and photographs (where possible and if permitted by the con- cerned people). Review data At the end of each day of data collection and interviews, the assessment team must debrief and begin to identify the key points, recurring themes, and issues emerging on the challenges and needs of an organized cervical cancer prevention and control program. During this daily debriefing any outstanding questions or missing information can be identified in order to mark key information that needs to be gathered during the following day’s interviews. Analyze data and make recommendations Once all the information has been collected, the assessment team should collate, synthesize, and analyze the information. is stage should be done in a group where all members can discuss the key points that emerged during the data collection phase and analyze any common themes or obvious gaps in the current cervical cancer prevention program. e team will analyze the information following the categories outlined in the previous section (What Needs to be Assessed), includ- ing new issues that arise during the course of conducting the needs assessment. Based on the findings and conclusions of the needs assessment, the team develops appropriate recommendations. Post-assessment phase Write the report A member of the assessment team should be designated as a writer, who in con- sultation with all assessment team members prepares the report documenting the methodology and findings. e designated writer should be selected based on her or his skills and abilities to write clearly and concisely and must collaborate with other members to agree on the presentation of findings. e report should be brief, with data to support findings wherever possible. e report should be completed in a timely manner. 50 Part Two: Planning and Managing a Program 4 51Chapter 4: Assessing Program Needs 4 Present and disseminate the report to stakeholders During meetings with key stakeholders, the assessment team presents their findings and conclusions, creates support for developing or strengthening a cervical cancer prevention program, and develops the plan for the program. e report should be disseminated to relevant stakeholders in a timely manner. Develop a program plan Once the stakeholders and authorities have reviewed the findings and accepted the recommendations, a program plan needs to be developed that delineates the activities, responsible organizations, and resources required to implement the rec- ommendations. Ideally the plan should be developed by the management team, in collaboration with the assessment team. e plan may require formal approval and acceptance by the stakeholders and organizations responsible for deliver- ing services (e.g., Ministry of Health or private-sector health service managers). Chapter 5 describes how to develop the program plan and a budget. Conclusion e second step in a program planning cycle (the first being to engage stakehold- ers) is for a multidisciplinary assessment team (task group) to collect and analyze information on local needs and availability of resources. Recommendations from this local assessment should be used to develop an action plan to implement a new program or to strengthen an existing program. Further Reading EngenderHealth. COPE® for Cervical Cancer Prevention Services: A Toolbook to Accompany the COPE® Handbook. New York: EngenderHealth; 2004. JHPIEGO. Cervical Cancer Assessment Checklist. Baltimore: JHPIEGO; 1999. Pan American Health Organization (PAHO). A Needs Assessment Guide for a Cer- vical Cancer Prevention and Control Program. Washington, D.C.: PAHO; 2002[a]. PATH. Program Capacity Assessment Tool: Integrating Cervical Cancer Prevention Into Reproductive Health Services. Seattle: PATH; 2001. Reproductive Health Reports, No. 4. 52 Part Two: Planning and Managing a Program 4 53Chapter 4: Assessing Program Needs 4 Appendix 4.1. Sample Questions to Assess the Use of Policies, Guidelines, and Norms is is a list of sample questions for interviewing health administrators and health professionals to understand their awareness and use of policies, guidelines, and norms related to cervical cancer prevention and control. ese questions could be adapted and modified to suit the specific situation concerning the policies, guide- lines, and health situation in your country. 1. Are you familiar with the reproductive health program that includes cervical cancer prevention? Are you aware of a national cancer control program which includes cervical cancer prevention? 2. In your opinion, how does cervical cancer prevention rank as a program priority within the health services? 3. In your opinion, what are the competing health priorities in this region/ area for cervical cancer prevention? 4. Are there assigned resources dedicated to cervical cancer prevention within the health authority’s budget? If so, are these resources adequate for the current level of programming? 5. Are you aware of the policies that govern the type of screening, diag- nosis, and treatment that is offered in the country? 6. What are the policies that govern the following aspects of cervical cancer prevention and control? a) Screening tests. b) Diagnostic tests. c) Treatment options for precancerous lesions. d) Treatment for cervical cancer. 7. Are there clinical practice guidelines (written or unwritten practice norms) for cervical cancer screening and treatment services? 8. What do the clinical practice guidelines state for the following areas: a) Age to initiate screening. b) Target age group for screening efforts. c) Coverage goals. d) Screening interval. e) Screening tests to use. f) Standard terminology for reporting screening results. g) Health professionals permitted to conduct the screening test and/or treatment for precancerous lesions. h) Methods to manage women with positive screening test results. 9. Do you accept the guidelines and use them in your practice? 10. Are there guidelines or laws that regulate opioid availability for pallia- tive care services? 11. Overall what are the strengths and weaknesses of the policies and guide- lines for cervical cancer prevention? 12. In your opinion how can the weaknesses be improved? 52 Part Two: Planning and Managing a Program 4 53Chapter 4: Assessing Program Needs 4 Appendix 4.2. Sample Questions to Assess Program Management Issues is is a sample list of questions for interviewing local key authorities in the Ministry of Health; those responsible for the reproductive health program, cancer control program, or chronic disease program; presidents and program managers from cancer institutes, cancer leagues, cancer societies, and other NGOs involved in cancer prevention; and members of medical associations, pathology associations, gynecologic associations, and oncology groups. ese questions could be adapted and modified to suit the specific situation concerning the health care infrastruc- ture, health priorities, and programs in your country. 1. Is there a program for cervical cancer prevention and control with defined goals, targets, and objectives? If no, could an organized program be developed? 2. Is there a national policy for cervical cancer screening and treatment? What is contained in the national policy about screening target age group and coverage targets? 3. How is or could the program be structured in terms of its management and delivery of services at the primary, secondary, and tertiary level of care? 4. Who is or could be responsible for leading and coordinating a cervical cancer prevention program? 5. Who is or could be responsible for serving as facility or area supervisor to monitor the implementation of the program in the health facility. 6. Approximately, what is the current screening coverage (percentage of women in the target population screened within the recommended interval)? Of the women screened, approximately what percentage of women received follow-up diagnosis/treatment? 7. Is there a functioning system to track women who require follow-up care and to reduce the number of women lost to follow-up? 8. Are women required to pay (totally or partially) for their screening test? For diagnosis (colposcopy and biopsy)? For treatment of precancerous lesions? For treatment of cervical cancer? If yes, what is the average cost to the woman for each service? 9. What are the indicators that are used, or could be used, to measure the program’s success? How can the program’s success be evaluated? 10. Overall, what are the strengths and weaknesses of the management of the cervical cancer prevention program? How can the weaknesses be improved? 54 Part Two: Planning and Managing a Program 4 55Chapter 4: Assessing Program Needs 4 Appendix 4.3. Sample Questions to Assess Health Services ese sample questions are for interviews with health care providers on issues related to the health services for cervical cancer screening, diagnosis, and treat- ment. ese questions could be adapted and modified to suit the specific situa- tion concerning the health care infrastructure, health priorities, and programs in your country. Screening 1. How are the screening services delivered: as part of the routine pre- ventive health services for women; as part of maternal and child health services; as a special campaign for cervical cancer prevention? Other? 2. What strategies are used to identify eligible women and to recruit these women for screening services? How can these strategies be improved? 3. Where are the screening tests performed: community health post, health center, doctor’s office, screening clinics, family planning clinics? Include the number of facilities and the number of tests performed per year. 4. Who performs the screening tests in the health clinic: general practi- tioner, nurse, other? What is the total number and type of health pro- fessionals providing the screening services? 5. Is special training offered to the health professional for perform- ing the screening test? Are refresher training courses offered? If so, how oen? 6. How is quality of care ensured for the women during the gynecologi- cal exam? How can this be improved? 7. With cytology, where are the screening tests analyzed and interpreted? Include the location and number of tests interpreted per year. 8. With cytology, what is the average length of time from when the screen- ing test is done to when results are provided to the woman? 9. How are women notified of their screening test results? Who com- municates the results to the woman? How well does this function? Is there counseling at the time results are provided? Is the woman given a copy of her results, or is it recorded in a client record card kept by the woman? 10. Is there sufficient equipment and supplies available in the health facility for screening services: gynecologic table, examination light, speculums, spatulas, slides, fixatives, clinic client forms, etc.? 11. Overall, what are the strengths and the weaknesses of the screening services? How can the weaknesses be improved? 54 Part Two: Planning and Managing a Program 4 55Chapter 4: Assessing Program Needs 4 Diagnosis (if applicable) 12. What diagnostic tests are available to women with positive screening test results? How are women referred for diagnostic follow-up? 13. Are diagnostic tests used prior to treatment to verify screening test results? Where are the diagnostic services delivered? Who performs the diagnostic test? 14. What standard procedures are undertaken by the health facility to ensure that women are followed up with diagnosis and it is done as recommended? What percentage of women actually complete diag- nosis? 15. How are women informed of their need for diagnostic follow-up? Is counseling provided to women at the time of their diagnosis? 16. On average, what is the length of time from when a woman is provided results from her screening test to the time of her diagnostic visit? 17. Overall, what are the strengths and the weaknesses of the diagnostic services? How can the weaknesses be improved? Treatment for Precancer and Cancer 18. What treatment options are offered to women detected with precan- cerous lesions? With cervical cancer? 19. Where is the treatment delivered and who provides the service? 20. How is the woman informed of the need for treatment and the type of treatment she will receive? Is the woman provided with counseling at the time of treatment? 21. On average, what is the amount of time that elapses between when a woman is diagnosed with precancerous lesions and when she receives her treatment? 22. Is data available on treatment success/failure rates, complications, and women lost to treatment follow-up? 23. Overall, what are the strengths and the weaknesses of the treatment services? How can the weaknesses be improved? 56 Part Two: Planning and Managing a Program 4 57Chapter 4: Assessing Program Needs 4 Appendix 4.4. Sample Questions to Assess Information and Education Activities ese are sample questions to be used for interviews with CHWs and health pro- viders involved in delivering community I&E activities. ese questions could be adapted and modified to suit the specific situation concerning the health care infrastructure, health priorities, and programs in your country. 1. Have there been studies to collect information on the knowledge, atti- tudes, and practices of women regarding cervical cancer screening and treatment? If so, what are the main findings? 2. Have there been studies to document the knowledge, attitudes, and practices of health care professionals regarding cervical cancer screen- ing and treatment? If so, what are the main findings? 3. What public educational materials are available to inform women of cervical cancer prevention? How are materials/messages delivered to women? What are the main messages? What are the strengths and weaknesses of the materials? How can the weaknesses be improved? 4. What health education strategies are conducted in the community to encourage women to be screened and to be informed of their screen- ing test results? How effective are these strategies? How can they be improved? 5. What health education strategies are undertaken in the health center to encourage at-risk women to be screened? 6. Are women themselves involved in communicating messages to their peers and educating women about cervical cancer screening? What evidence is there for the level and degree of peer communication in the community? 7. What institutions are or could be involved in community strate- gies to involve women and improve their participation in screening programs? 8. How are the information and education activities financed? What is the budget for these activities? 56 Part Two: Planning and Managing a Program 4 57Chapter 4: Assessing Program Needs 4 Appendix 4.5. Sample Questions to Assess Community Perspectives ese are sample questions for interviews with women and men from the com- munity regarding their knowledge, needs, and concerns related to cervical cancer. ese questions could be adapted and modified to suit the specific situation and circumstances in your community. Knowledge of cervical cancer 1. What do you know about cancer? 2. What have you heard about cancer that affects the cervix/vagina/uterus/ womb? 3. If nothing, what kind of sicknesses do you know of that can affect the woman in her reproductive organs? The concept of preventing disease 4. How do you avoid getting sick? 5. How do you protect your children from getting sick? 6. If you get sick, how do you avoid getting worse? 7. How do you think this concept of preventing disease could apply to cancer? To cervical cancer, in particular? Awareness of cervical cancer prevention services 8. What have you heard about cervical cancer prevention/screening/ testing services in your area? 9. Do you know where to access these services? 10. Do you know from whom you can get information on these services? Feelings about screening 11. [For women] Have you ever had a pelvic exam or a speculum exam? (Explain, as necessary, this is when the health worker feels [pelvic exam] or looks [speculum exam] inside your vagina to check that everything is fine.) If yes, how did you feel about that experience? If no, how do you think you would feel about such an exam? 12. How would you feel about having a pelvic exam if it could help to prevent you from getting cervical cancer? 13. How do you think your women friends or relatives would feel about having pelvic examinations? 14. How do you think your husband or partner would feel about you having a pelvic examination? 15. [For men] How would you feel about having your wife or partner get a pelvic exam and a screening test if it could prevent her from getting cancer? 58 Part Two: Planning and Managing a Program 4 59Chapter 4: Assessing Program Needs 4 Possible barriers to utilizing screening services 16. What has made it difficult or might make it difficult for you [men: “for your partner”] to go for cervical cancer screening services? (Explore by asking, “How about. . . ”: your feelings about cancer and/or about the pelvic exam, your husband’s or partner’s approval, family approval, where the services are offered, who is providing the services, transpor- tation problems, cost concerns, having to travel far, missing work, or having to get others to look aer children.) 17. What would make it easier for you [for your partner] to go for cervical cancer screening services? (Explore, depending on the previous answers.) Attitudes toward the health care system 18. Where do you normally go for health care? For reproductive health care? 19. What do you think about the quality of services provided there? 20. Do they meet your needs? 21. How do you feel about the way you are treated when you go there? 22. Would you be comfortable going there for cervical cancer prevention services? If no, why not? 23. What could help you change your opinion? Location and timing of services 24. Where would be the best place for you to go for cervical cancer screen- ing? 25. What would be the best time (time of day, day of the week, season of the year)? 58 Part Two: Planning and Managing a Program 4 59Chapter 4: Assessing Program Needs 4 Appendix 4.6. Sample Questions to Assess a Laboratory ese are sample questions for interviews with laboratory directors, pathologists, technicians, and other key laboratory personnel to assess the histopathology labo- ratories. ese questions could be adapted and modified to suit the specific situa- tion concerning the health care infrastructure and laboratories in your country. National issues 1. How many pathology laboratories exist in the country by health district/ region? 2. Is the laboratory system centralized or decentralized? 3. Is there a national reference laboratory? Does it conduct external quality reviews of the cytology and histopathology conducted by the regional laboratories? 4. How many cervical cytology tests and cervical biopsy tests does each laboratory process on average each year? 5. What terminology is used by the laboratories to report results of screen- ing tests and of biopsy tests? Is this standardized nationally? 6. How many cytopathologists and cytotechnicians exist in each labora- tory? What type of training are they provided? 7. How many cervical cytology tests does each cytotechnician read on average on a daily basis and on an annual basis? 8. Is the quality of the cytotechnician’s work evaluated and monitored to ensure quality of the cervical cytology test results? How is this achieved? 9. How is the quality of the pathologist’s work evaluated and monitored to ensure quality of the biopsy test results? Local issues 10. How does the laboratory register the reception of the tests? Is a unique identifier code assigned for each woman? 11. What terminology is used for notification of results? Who is responsible for the final report? To whom does the report go? Who is responsible for follow-up of abnormal test results? 12. How does the laboratory report the test result back to the correspond- ing health center/screening site? What linkages exist? How easy is it to access and retrieve these test results? 13. On average, what is the time delay from when a sample is received to when results are recorded and sent back to the health care site? On average what is the amount of samples that are backlogged for inter- pretation? What is the primary cause of this backlog? 14. What percentage of samples is lost to breakage during transportation? 60 Part Two: Planning and Managing a Program 4 61Chapter 4: Assessing Program Needs 4 15. What are the procedures for reception and daily recording of slides received (e.g., numerical order of receipt, date of receipt, full name, place that smear is taken)? Are these procedures done by hand or computerized? 16. What internal measures does the laboratory use for quality control? 17. Does the laboratory routinely correlate the abnormal screening test results with the histopathology results? If no, why not? 18. Is retraining offered for technicians who consistently have errors in interpretation? 60 Part Two: Planning and Managing a Program 4 61Chapter 4: Assessing Program Needs 4 Appendix 4.7. Sample Questions to Assess Information Systems ese sample questions are for interviews with program managers, health admin- istrators, HIS staff, data entry personnel, health providers, and others involved in recording and managing client information related to cervical cancer. ese ques- tions could be adapted and modified to suit the specific situation concerning the health care infrastructure and HISs in your country. 1. Is there a unique personal identifier in general use for health data? If so, is this a health system number or a more broadly used personal identifier? 2. How is information about cervical cancer screening and follow-up currently collected and organized? If this is not being done, what are the main challenges and obstacles to information collection and monitoring? 3. For what purpose does or could the program use the information system? ___ Day-to-day screening operations (i.e., generating specimen reports). ___ Routine recall. ___ Follow-up of positive results. ___ Quality control. ___ Statistical reports to labs, health centers, and/or test takers. ___ Statistical reports for program managers. 4. What process (log book, filing system, or computer system) is used or could be used to register information and test results for the cervical cancer program? 5. Are there standard reporting forms for screening, for diagnosis, and for treatment services? 6. Does the program have access to population counts for its target pop- ulation (i.e., women in your target age range)? 7. Are there any other types of data that the cervical cancer program has access to which might be useful for improving a data system to manage and monitor the program (e.g., individual death records, hysterectomy records, etc.)? 8. Is there a cancer registry available in the country to monitor incidence and mortality rates from cervical cancer? 62 Part Two: Planning and Managing a Program 5 63Chapter 5: Planning, Preparing, and Launching the Program 5 Planning, Preparing, and Launching the Program Contents Key Messages . 63 Introduction . 63 Role of the Management Team . 63 Cost Considerations . 64 Achieving high screening coverage Offering a high-quality, effective, and acceptable test Ensuring treatment of test-positive women Additional considerations The Program Action Plan . 65 Local screening coverage goals Estimates for treatment services Service delivery strategies The Program Budget. 69 Establishing Systems for Service Delivery. 73 Develop program materials Establish linkages with community and facilities Provide orientation for community, stakeholders, and staff Ensure provider training and availability Procure and distribute equipment and supplies Establishing Systems for Supervision, Monitoring, and Evaluation . 74 Set up the systems for supervision Build capacity to ensure quality Defi ne the program indicators Set up the information system Launching the Program . 77 Conclusion . 77 5 C H A P T E R 62 Part Two: Planning and Managing a Program 5 63Chapter 5: Planning, Preparing, and Launching the Program 5 Key Messages • Systematic planning is critical to the success of the program. Sufficient time should be allocated to plan a new program or to strengthen an existing program. • A plan should be developed to define the targets, strategies, and actions for achieving high screening coverage, offering a high-quality and effec- tive screening test, and ensuring treatment of women with positive screening test results. • Decisions about the strategies to be included in the program plan must be informed by cost-effectiveness considerations. is means weighing the costs of various strategies against the impact they will have on the program. • Sufficient financial resources need to be invested in the program in order for it to succeed. e allocation of resources must be strategic to maximize the impact of the program. • Prior to launching the program, the systems and capacity for quality service delivery must be established so that providers can meet clients’ right to quality care. • Launch the program with an inaugural event to generate enthusiasm for its implementation among providers and community members. Introduction Following the needs assessment, a program plan should be developed to describe the targets, strategies, and actions that will be implemented to achieve the pro- gram’s overall goals. ese goals should be to achieve a high screening coverage of the women in the target age group, make certain that the screening test is effec- tive and acceptable, and ensure that all test-positive women are treated appropri- ately. It is important to allocate sufficient time up front (e.g., 6 to 12 months) to plan and prepare all programmatic components before launching a new program or a strengthened program. It is particularly important to ensure that all service elements are in place before launching the program in the community. Role of the Management Team e management team’s role is to map out local strategies that cover all program- matic areas, based on the needs assessment findings and considering cost-effec- tiveness. Specific tasks include: • Defining the local programmatic targets, such as screening coverage and treatment for women detected with precancerous lesions. • Developing the service delivery strategies for each component of the program: community information and education (I&E), screening services, and diagnostic and treatment services. 64 Part Two: Planning and Managing a Program 5 65Chapter 5: Planning, Preparing, and Launching the Program 5 • Identifying the specific locations where services will be offered and determining the equipment, training, and resources (human and finan- cial) needed at each site. • Developing a program budget. • Establishing systems for service delivery and quality management. • Launching the program. Cost Considerations When deciding which strategies to include in the program action plan, the man- agement team must know the amount of financial resources that are available and how they will be allocated to each strategy. is is because the effectiveness of the program will be affected by the funds devoted to the strategies for achieving high screening coverage, offering high-quality tests, and ensuring treatment of test- positive women. However, there is a threshold beyond which adding more funds to the program will not necessarily yield proportional additional benefits to screen- ing coverage, test quality, or treatment of test-positive women. is threshold will vary with countries, settings, and strategies used. Achieving high screening coverage e strategies to achieve high screening coverage include making screening services widely available and accessible to women in the appropriate age group, as well as ensuring that people are informed about and aware of the importance of the services. Examples of activities include conducting large-scale promotional events or campaigns, contacting women and their partners in their homes, and sending health providers out to rural areas (mobile services). e relative cost-effective- ness of these strategies must be compared: • Mobile services increase coverage by increasing accessibility to the services, particularly in rural areas, but they are costly and difficult to organize. • In some settings, home visits and enumeration can be cost-effective, especially for estimating the size of the eligible population, advocating screening at the household level, and facilitating follow-up of women to be treated. Offering a high-quality, effective, and acceptable test • Quality assurance procedures are necessary to achieve a high-quality screening test and accurate test results. e costs of initiating and main- taining a quality assurance component to a screening program must be formally considered. • e relative costs and benefits associated with cytology screening programs are influenced by the maintenance of a constant and adequate workload for laboratory staff in order for them to maintain proficiency. With low workloads, the costs of the laboratory staff and equipment become high in relation to the effectiveness of the program. 64 Part Two: Planning and Managing a Program 5 65Chapter 5: Planning, Preparing, and Launching the Program 5 On the other hand, an excessive workload will reduce the quality of the screening test and compromise the effectiveness of the program. • Visual inspection screening methods are associated with lower direct medical costs than cytology and HPV DNA testing because non-phy- sicians can perform them, there is no need for laboratory support, and they involve less equipment and supplies. ere are, however, costs associated with the thorough and ongoing quality assurance activities needed to achieve high-quality and accurate test results over time and these must be formally considered. Ensuring treatment of test-positive women e ultimate effectiveness of the program depends on treating test-positive women, so that cervical cancer does not develop from precancerous lesions. Dedicating resources to reducing “loss to follow-up” (i.e., ensuring that women who are iden- tified with precancerous lesions actually receive treatment) will have a great impact on program effectiveness. us, resources should be strategically allocated to strate- gies that may reduce loss to follow-up, such as generating up-to-date lists of women who need to be treated, having sufficient staff available to offer treatment services, and offering services at times that are convenient for women. Additional considerations In addition to these considerations, unexpected events like frequent staff absences or breakdown of equipment may increase costs and reduce program effective- ness. Program strategies that involve reducing the number of visits for women and reducing requirements such as sophisticated equipment or frequent training sessions may reduce the probability or impact of unexpected events and increase cost-effectiveness. The Program Action Plan In the planning phase, the policy decisions made at the national level (e.g., target age group, coverage goals, and screening frequency) will be applied to the local program action plan in order to set local program targets. e local targets include the number of women to be screened in each service delivery area, the estimated number of women to be treated, and the most effective strategies for providing such services. Local screening coverage goals Coverage refers to the percentage of women in the target population who actually receive screening services during a given time period. Greater reductions in the incidence of cervical cancer will be achieved by ensuring that a large proportion of women are screened and treated for precancer. Screening of women outside the target age group or routine rescreening of the same women can reduce the effec- tiveness of the program. erefore, objectives of the screening strategy should include screening women who have never been screened before and focusing on women in the target age group. 66 Part Two: Planning and Managing a Program 5 67Chapter 5: Planning, Preparing, and Launching the Program 5 To achieve the desired coverage in a specified time period, the management team should estimate the size of the target age group in their area, and then calculate how many of these women need to be screened within a specified time. Figure 5.1 shows a method to calculate the expected number of women to be screened on a monthly basis for a district or region over a given time period. e information needed for this calculation includes: • Population of women in the target age group residing in the area. • Coverage goal set by national policy. • Number of years for the program to achieve its coverage goal. FIGURE 5.1. Method to calculate the monthly screening coverage targets* * is method assumes that no women in the target population have been screened; this is a reasonable assump- tion in most low-resource settings. Source: Adapted from CHIP 2004a. Population statistics of women in the target age group can be collected from census data (if available), by enumerating women in the target age group using a commu- nity survey, or from an estimate of the population in the area. An example of how to use this method to calculate the number of women to be screened is shown in the box opposite. is example does not account for annual population increases in the number of women in the target age group—an important consideration in program planning. A. Estimate the population in the service delivery area. B. Estimate the number of females. C. Estimate the number of females 30 years or older (or whatever is the target age group for screening). D. Determine the total number of NEW screening tests necessary to achieve the desired coverage for the program. E. Determine the number of NEW screening tests the area must provide every year to achieve the desired coverage during the target time period, and how many must be provided every month. A. From a census or community population survey. B. If unknown, assume 51% of A is female. C. If unknown, use national figures. D. Multiply C by the % of the desired coverage. E. Divide D by the number of years projected for the program. Then divide by 12 for the monthly target. 66 Part Two: Planning and Managing a Program 5 67Chapter 5: Planning, Preparing, and Launching the Program 5 Example: How to Estimate the Monthly Screening Target In this example, the program’s goal is to screen 80% of women aged 30 years or older, over a five year period, within a defined geographic area. A. Identify the size of the population in the area (e.g., from census data). Example: e census reports that there are 250,000 people in the area. B. Calculate the number of women in the area. Example: Approximately 51% of the population is female. erefore, there are an estimated 127,500 women in this area (51% of 250,000). C. Estimate the number of women in the target age group to be screened. Example: e census reports that 40% of the population is aged 30 years or older. erefore, the estimated number of women aged 30 years and older in this area is 51,000 (40% of 127,500). D. Calculate the TOTAL number of women to be screened. Example: e program goal is to screen 80% of women aged 30 years or older, which is 40,800 women (80% of 51,000). E. Calculate the MONTHLY number of women to be screened. Example: 40,800 to be screened over 5 years = 8,160 women each year. erefore, for each month the screening target is 680 women (8,160 divided by 12). Estimates for treatment services Follow-up diagnosis (where applicable) and treatment services will be required for all women with positive screening results. erefore, the goal will be to provide these services to 100% of women who screen positive. In order to plan the strate- gies to achieve this goal and to budget for adequate staff and resources, the man- agement team needs to calculate the number of women expected to have a positive screening test result that will require follow-up diagnosis and treatment for pre- cancerous lesions. Table 5.1 provides an example of how to do this. 68 Part Two: Planning and Managing a Program 5 69Chapter 5: Planning, Preparing, and Launching the Program 5 TABLE 5.1. Examples of estimating caseload of women requiring post-screening care Category of client How to estimate targets Women screened positive who will require follow-up care. Number of women screened times the screening test-positivity rate (5%–25% depending on the screening test used). Women who will require treatment of precancerous lesions with cryotherapy. 80%–85% of women diagnosed with precancerous lesions will be eligible for cryotherapy treatment. Women who will require referral for cancer management. 0.5%–1% of all women screened. ese estimates will be useful when planning and procuring supplies for the clinical services. For example, when planning and procuring cryotherapy supplies, it is useful to have an estimate of the expected number of cryotherapy treatments to decide on the number and size of cryotherapy gas tanks (nitrous oxide or carbon dioxide). See Appendix 6.2 for information on different tank sizes. Service delivery strategies Once the screening coverage goals and estimated caseload for follow-up care have been established, the program plan should define how the services would be deliv- ered in order to meet these goals and targets. is plan will include: • Deciding whether to have a phased (vertical to integrated services) or combined (integrated plus vertical services) approach to implement the services. • Deciding on the geographic locations and sites for screening and treat- ment services that will facilitate achieving coverage goals. • Deciding on the supplies, equipment, and infrastructure needed for each service site. Deciding on a phased or combination approach New programs may benefit from the phased approach, which is to implement vertical services at the start of the program and later move toward integrated services (discussions of vertical and integrated services are found in Chapters 2 and 6). At the start of a new program, only a limited number of trained staff will be available. Having staff dedicated to only one health service is likely to promote higher commitment and focus on the objectives of the program. In addition, staff are likely to gain more experience performing the screening and treatment proce- dures. As the program matures, an increased number of staff will be trained and experienced and there will be greater community awareness to enable the program to move toward integrated services. Countries with existing cervical screening programs may use a combination of integrated services and vertical services, for instance, integrating cervical cancer prevention services with general reproductive health services. ey can be supple- mented with vertical services, such as occasional mass campaigns. 68 Part Two: Planning and Managing a Program 5 69Chapter 5: Planning, Preparing, and Launching the Program 5 Deciding the geographic location for services When deciding their target area, new programs will increase their chances of success by initially limiting the geographic scope of their activities, that is, by starting in a well-defined area and then gradually expanding to other regions as technical capacity and financial resources allow. Having a well-defined area facil- itates achieving coverage goals for screening and increases chances of tracking women for follow-up. is “pilot phase” allows real-life testing of the service delivery approach chosen and provides important information on corrective actions that may be needed before expanding services to a larger area. Information from the local needs assessment (see Chapter 4) can help management teams to identify areas with the greatest need and readiness, and to map appro- priate locations for providing cervical cancer prevention services. Areas with the greatest need, however, are oen the ones with the fewest resources. Both urban and rural settings have features that can limit or facilitate establishing and main- taining services. If the management team has the authority to select service delivery sites, they should consider the following factors: • Geographic accessibility for clients. • Ease of client tracking. • Proximity to laboratories and treatment facilities. • Range of human and equipment resources. • Locations with large populations needing screening. Decide on the supplies, equipment, and infrastructure e supplies, equipment, and infrastructure for each service site need to be defined so that these will be sufficient to meet the screening coverage and follow-up targets. e information gathered during the needs assessment will guide the management team to decide on the specific equipment and supplies needed, as well as quantify the required equipment and supplies to achieve the coverage goals. e list of equip- ment and supplies required for a cervical cancer prevention and control program is contained in Appendix 6.1. Strategies for distributing and storing equipment and supplies must be established to ensure a constant flow to the health facilities. Mechanisms must also be established for repairing and maintaining equipment. Planning activities related to other components of the cervical cancer prevention program—I&E, training, and monitoring and evaluation—are described in detail in Part 3. Planning activities related to cervical cancer treatment can be found in Chapter 10. The Program Budget Aer establishing the program’s goals, targets, and strategies, the management team needs to estimate the cost of carrying out the program plan at the local level. e required funds should be allocated based on the need for each service site to have adequate resources, including skilled personnel, equipment, and supplies to serve the anticipated number of women. e case study on the next page illustrates the costs of an organized screening project in a rural part of India. 70 Part Two: Planning and Managing a Program 5 71Chapter 5: Planning, Preparing, and Launching the Program 5 Once the required funds have been determined, the management team should identify whether resources are currently available, whether additional resources are required, and where the new resources will come from. Existing human and material resources may be sufficient, but additional resources and funds will oen be required. If resources are limited, it is advisable to begin a program in a smaller area and later expand services as additional resources become available. Case Study: Costs of an Organized Screening Project in a Region of Rural India A large screening research project with a target population of 100,000 previously unscreened women has been established in rural Barshi, India, without preexisting infrastructure. Mobile clinics were used to screen women with VIA, cytology, or HPV DNA testing in the villages. Women who screened positive were provided transportation to the rural hospital for diagnosis and treatment. On average, the project screened 25,000 women per year. About US$1,000,000 was allocated to cover the full cost of all aspects of this project. e total cost per eligible women ranged from $4.30 to $12.40, depending on the screening test. Between 8% and 21% of these costs were attributable to program-level costs, including infrastructure changes, implementation and management, and establishing an HIS. Overall, recruitment and invitation accounted for between 6% and 17% of the total cost of screening women. e preliminary results of the project showed that high levels of participation (79%) and treatment (83% of the women with lesions were treated) can be achieved and that a screening program can be established with satisfactory performance in a very limited-resource setting. Source: Legood et al. 2003. 70 Part Two: Planning and Managing a Program 5 71Chapter 5: Planning, Preparing, and Launching the Program 5 e next box provides a list of items to be considered when developing a program budget, whether it is for a new program or strengthening an existing program. is list assumes that the basic women’s health service infrastructure is already estab- lished, and therefore resources are not required for basic start-up of services. Items to Consider in Developing the Annual Program Budget Community involvement • Salaries and incentives for health promoters or CHWs. • Printing of educational and promotional materials. • Media (TV, radio, or other media announcements). • Community education sessions: • Travel costs for personnel to visit communities. • Physical requirements (e.g., room, chairs, flip charts, materials). • Paper, photocopies, and other office supplies. Training • Payment for the trainer(s). • Travel costs for the trainer(s) and trainees. • Honorarium or per diem for health personnel to attend training sessions (if applicable). • Physical requirements for training: • Room rental. • Gynecologic model (where used). • Presentation materials (projector, screen, paper, etc.). • Supplies for screening and treatment. • Invitations to women to participate in a gynecologic examina- tion by health providers during their practical training session. • Administrative support. Screening services • Salaries for health personnel involved in screening (including cytology laboratory personnel if applicable). Consideration should be given to the number and type of health personnel required in each health center to provide screening and the time required to perform the services. • Equipment and supplies for primary health care centers for screening. • Equipment and supplies for cytology laboratories to process screening tests. • Clinical forms to collect information and record test results. Ü 72 Part Two: Planning and Managing a Program 5 73Chapter 5: Planning, Preparing, and Launching the Program 5 Diagnostic and/or treatment services • Salaries for health personnel involved in diagnosis and treatment (including pathology laboratory personnel, if applicable). • Equipment and supplies for diagnosis and/or treatment and palliative care (please refer to the detailed list of equipment and supplies contained in Chapter 6). • Equipment and supplies for pathology laboratories to process biopsies (if used). • Clinical forms to collect information and record results. • Hospital-based care for women with cancer (this will probably be included in hospital budgets). Monitoring and evaluation • Salary for program staff for record keeping, data entry, generating progress reports, and computer support (where used). • Paper, photocopies, and other office supplies for monitoring and reporting purposes. • Computer and information system soware for monitoring and reporting purposes (if applicable). • Meeting costs (room, hospitality, travel) to meet regularly with area supervisors to discuss results. Program support costs • Salary for program manager, administrative assistant, and other personnel required to oversee and manage the program. • Transportation for the manager and the area supervisors to make supervisory visits to health centers. • Transportation for sending screening test samples to the cytology laboratory. • Transportation for sending histopathology samples to pathology laboratories. • Recruitment of new health personnel and program staff. • Storage and distribution of equipment and supplies to health centers. • Repair and maintenance of equipment for diagnosis and treatment. • Health center infrastructure, where it is needed (e.g., gynecology table). 72 Part Two: Planning and Managing a Program 5 73Chapter 5: Planning, Preparing, and Launching the Program 5 Establishing Systems for Service Delivery Once the program action plan and budget have been defined, preparations need to be made to ensure that all the necessary systems to deliver quality services are in place before program launch. Establishing systems for service delivery means ensuring that the relevant program materials are developed and made available, linkages are established between community and facilities, providers are trained and available, equipment and supplies are procured and distributed, and stake- holders and staff are fully oriented on the program’s goal and strategies. Most of these preparatory activities will need to take place concurrently. In this regard, the management team will need to set realistic timelines, organize appro- priate task groups, and coordinate these activities to ensure that all preparations are completed in a timely manner prior to launching the program. It is important to set up the systems and build capacity before launching services, so that clients will find facilities and staff ready when they seek services. Develop program materials All necessary program materials required to support the program plan, such as I&E materials, training materials, and clinical forms, should be developed. If program materials currently exist, it may be useful to review them to determine whether they need to be modified. If no program materials exist, new ones will need to be created, based on the contents of the national policies. Training manuals, curricula, and course agendas are developed by the trainers who will conduct the training. Developing I&E materials can require much time, effort, and resources. Wherever possible, therefore, it is best to adapt existing materials. e ACCP has ample such material, both for I&E and for training, which can be adapted and translated to ensure it is locally applicable and appropriate. ese materials are listed in Appendices to Chapters 7 and 8. Establish linkages with community and facilities An effective cervical cancer prevention program requires a well-functioning referral network to ensure continuity of care for the client. Program planners should set up a referral task team, develop referral protocols and tools, and identify and upgrade referral facilities, as well as establish and maintain feasible communica- tion systems. In addition, linkages should also be established with laboratories, other health sectors, data processing centers, and above all with the community. Refer to Chapter 6 for details on establishing and maintaining linkages. Provide orientation for community, stakeholders, and staff To promote the cervical cancer prevention program, both in the community and within the health care facilities, orientation to the program should be provided to all cadres of staff, stakeholders, and community groups. eir roles and responsi- bilities within the plan need to be clearly communicated so that they are prepared to participate in the program’s implementation. ey also need to be made aware of and familiarized with the program materials such as I&E material and clinical forms. 74 Part Two: Planning and Managing a Program 5 75Chapter 5: Planning, Preparing, and Launching the Program 5 Ensure provider training and availability Before launching the program, the management team should ensure there will be sufficient numbers of qualified staff to attract women to services, provide screening, and treat those who test positive. Training should be conducted according to the plan developed. It is important not to conduct the clinical training too early in the program planning phase to avoid providers losing their newly acquired skills and enthusiasm. Refer to Chapter 8 for further information on training providers. Procure and distribute equipment and supplies e health facility sites will need to meet basic requirements for service delivery such as running water, adequate ventilation and lighting, functioning equipment, and available supplies. Facilities should be available to store equipment, stock supplies, and file client records. Procurement and distribution of the necessary equipment and supplies should begin at least three months before launching the program. e following factors should be considered: • Types of equip
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