WHO Comprehensive Cervical Cancer Control Guide

Publication date: 2006

Comprehensive Cervical Cancer Control A guide to essential practice ISBN 92 4 154700 6 (NLM classification: WP 480) ISBN 978 92 4 154700 0 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. 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Printed in Switzerland 1.Uterine cervical neoplasms - diagnosis. 2.Uterine cervical neoplasms - prevention and control. 3.Uterine cervical neoplasms – therapy. 4.Guidelines. I.World Health Organization. WHO Library Cataloguing-in-Publication Data Comprehensive cervical cancer control : a guide to essential practice. ACKNOWLEDGEMENTS This practice guide has been developed by the Department of Reproductive Health and Research and the Department of Chronic Diseases and Health Promotion of the World Health Organization (WHO), with the International Agency for Research on Cancer (IARC), the Pan American Health Organization (PAHO), and in collaboration with the Alliance for Cervical Cancer Prevention (ACCP), the International Atomic Energy Agency (IAEA), the International Federation of Gynecology and Obstetrics (FIGO), the International Gynecologic Cancer Society (IGCS), and the European Association for Palliative Care (EAPC). The guide is based on the work of a large group of experts, who participated in consultations or reviews. WHO gratefully acknowledges the contributions of: • the members of the Technical Advisory Group (TAG) panel: Rose Ann August, Paul Blumenthal, August Burns, Djamila Cabral, Mike Chirenje, Lynette Denny, Brahim El Gueddari, Irena Kirar Fazarinc, Ricardo Fescina, Peter Gichangi, Sue Goldie, Neville Hacker, Martha Jacob, Jose Jeronimo, Rajshree Jha, Mary Kawonga, Sarbani Ghosh Laskar, Gunta Lazdane, Jerzy Leowski, Victor Levin, Silvana Luciani, Pisake Lumbiganon, Cédric Mahé, Anthony Miller, Hextan Ngan, Sherif Omar, Ruyan Pang, Julietta Patnick, Hervé Picard, Amy Pollack, Françoise Porchet, You-Lin Qiao, Sylvia Robles, Eduardo Rosenblatt, Diaa Medhat Saleh, Rengaswamy Sankaranarayanan, Rafaella Schiavon, Jacqueline Sherris, Hai-Rim Shin, Daiva Vaitkiene, Eric Van Marck, Bhadrasain Vikram, Thomas Wright, Matthew Zarka, Eduardo Zubizarreta. • the external reviewers: Jean Ahlborg, Marc Arbijn, Xavier Bosch, Elsie Dancel, Wachara Eamratsameekool, Susan Garland, Namory Keito, Ntokozo Ndlovu, Twalib Ngoma, Abraham Peedicayil, Rodrigo Prado, John Sellors, Albert Singer, Eric Suba, Jill Tabutt Henry. • the many reviewers who assisted in field-testing the guide in China, Egypt, India, Lithuania, Trinidad, and Zimbabwe. Reproductive Health and Research FIGO ACCPIARC IGCS PAHO WHO coordinating team: Patricia Claeys, Nathalie Broutet, Andreas Ullrich. WHO writing and designing team: Kathy Shapiro, Emma Ottolenghi, Patricia Claeys, Janet Petitpierre. Core group: Martha Jacob (ACCP), Victor Levin (IAEA), Silvana Luciani (PAHO), Cédric Mahé (IARC), Sonia Pagliusi (WHO), Sylvia Robles (PAHO), Eduardo Rosenblatt (IAEA), Rengaswamy Sankaranarayanan (IARC), Cecilia Sepulveda (WHO), Bhadrasain Vikram (IAEA), as well as the members of the coordinating and writing teams. WHO is grateful to the Flemish Government (Belgium) for providing the main funding for this document. Other donors, who are also gratefully acknowledged, include the Alliance for Cervical Cancer Prevention, the International Atomic Energy Agency, Grounds for Health, and the European Coordination Committee of the Radiological and Electromedical Industry. CONTENTS Abbreviations and acronyms used in this Guide . 1 Preface . 3 Introduction. 5 About the Guide . 5 Levels of the health care system . 9 Essential reading . 10 WHO Recommendations . 11 Chapter 1: Background . 13 Key points . 15 About this chapter . 15 Why focus on cervical cancer? . 16 Who is most affected by cervical cancer?. 18 Barriers to control of cervical cancer . 19 The four components of cervical cancer control . 20 A team approach to cervical cancer control . 22 Additional resources . 23 Chapter 2: Anatomy of the female pelvis and natural history of cervical cancer . 25 Key points . 27 About this chapter . 27 Anatomy and histology . 28 Natural history of cervical cancer . 35 Additional resources . 42 Chapter 3: Health promotion: prevention, health education and counselling . 43 Key points . 45 About this chapter . 45 Health promotion . 45 The role of the provider . 46 Prevention of HPV infection . 46 Health education . 48 Counselling . 53 Health education and counselling at different levels . 55 Additional resources . 56 Practice sheet 1: Health education . 59 Practice sheet 2: Frequently asked questions (FAQs) about cervical cancer . 63 Practice sheet 3: How to involve men in preventing cervical cancer . 67 Practice sheet 4: Counselling . 69 Practice sheet 5: How to use male and female condoms . 73 Chapter 4: Screening for cervical cancer . 79 Key points . 81 About this chapter . 81 Role of the health care provider . 81 Screening programmes . 83 Screening tests . 92 Follow-up . 101 Screening activities at different levels of the health system . 103 Additional resources . 105 Practice sheet 6: Obtaining informed consent . 107 Practice sheet 7: Taking a history and performing a pelvic examination . 109 Practice sheet 8: Taking a Pap smear . 115 Practice sheet 9: Collecting samples for HPV DNA testing . 119 Practice sheet 10: Visual screening methods . 123 Chapter 5: Diagnosis and management of precancer . 125 Key points . 127 About this chapter . 127 Role of the provider . 127 Management options for precancer . 129 Diagnosis . 130 Treatment of precancer . 133 Follow-up after treatment . 142 Diagnosis and treatment activities at different levels . 143 Additional resources . 145 Practice sheet 11: Colposcopy, punch biopsy and endocervical curettage . 147 Practice sheet 12: Cryotherapy . 151 Practice sheet 13: Loop electrosurgical excision procedure (LEEP) . 155 Practice sheet 14: Cold knife conization . 161 Chapter 6: Management of invasive cancer . 165 Key points . 167 About this chapter . 167 The role of the provider . 167 Diagnosis . 169 Cervical cancer staging . 170 Principles of treatment . 176 Treatment modalities . 179 Patient follow-up . 186 Special situations . 187 Talking to patients who have invasive disease and to their families . 188 Management of invasive cancer: activities at different levels . 190 Additional resources . 191 Practice sheet 15: Hysterectomy . 193 Practice sheet 16: Pelvic teletherapy . 199 Practice sheet 17: Brachytherapy . 205 Chapter 7: Palliative care . 209 Key points . 211 About this chapter . 211 The role of the health care provider . 212 A comprehensive approach to palliative care . 214 Managing common symptoms of extensive cancer . 217 Death and dying . 220 Organization of palliative care services . 222 Palliative care at different levels of the health system. 223 Additional resources . 224 Practice sheet 18: Pain management . 225 Practice sheet 19: Home-based palliative care . 231 Practice sheet 20: Managing vaginal discharge and fistulae at home . 237 Annex 1: Universal precautions for infection prevention . 241 Annex 2: The 2001 Bethesda system . 245 Annex 3: How is a test’s performance measured? . 247 Annex 4: Flowcharts for follow-up and management of patients according to screen results . 249 4a. Standard approach and example based on pap smear screening . 249 4b. The “screen-and-treat” approach, based on visual inspection with acetic acid as screening test . 251 Annex 5: Standard management of cervical precancer . 253 Annex 6: Cervical cancer treatment by stage . 255 6a. Treatment of microinvasive carcinoma: Stage IA1 and IA2. 255 6b. Treatment of early invasive cancer: Stage IB1 and IIA < 4 cm . 256 6c. Treatment of bulky disease: Stage IB2-IIIB . 257 6d. Treatment of Stage IV . 258 6e. Cervical cancer management during pregnancy . 259 Annex 7: Sample documents . 261 7a. Sample letter to patient with an abnormal Pap smear who did not return for results at expected time . 261 7b. Sample card that can be used as part of a system to track clients who need a repeat Pap smear. . 262 7c. Sample card that can be used as part of a system to track patients referred for colposcopy. 263 7d. Sample letter informing referring clinic of the outcome of a patient’s colposcopy. . 264 Annex 8: Treatment of cervical infections and pelvic inflammatory disease (PID) . 265 8a. Treatment of cervical infections . 265 8b. Outpatient treatment for PID . 266 Annex 9: How to make Monsel’s paste . 267 Glossary . 269 1 ABBREVIATIONS AND ACRONYMS USED IN THIS GUIDE AGC atypical glandular cells AIDS acquired immunodeficiency syndrome AIS adenocarcinoma in situ ANC antenatal care ASC-H atypical squamous cells: cannot exclude a high-grade squamous intra-epithelial lesion ASC-US atypical squamous cells of undetermined significance CHW community health worker CIN cervical intraepithelial neoplasia CIS carcinoma in situ CT computerized tomography DNA deoxyribonucleic acid EBRT external beam radiotherapy ECC endocervical curettage FAQ frequently asked question FIGO International Federation of Gynecology and Obstetrics FP family planning HBC home-based care HDR high dose rate HIV human immunodeficiency virus HPV human papillomavirus HSIL high-grade squamous intraepithelial lesion HSV herpes simplex virus IEC information, education and communication IUD intrauterine device LDR low dose rate LEEP loop electrosurgical excision procedure LLETZ large loop excision of the transformation zone LSIL low-grade squamous intraepithelial lesion MRI magnetic resonance imaging 2 NCCP national cancer control programme NSAID nonsteroidal anti-inflammatory drug OC oral contraceptives PHC primary health care PID pelvic inflammatory disease PS practice sheet RTI reproductive tract infection SCJ squamocolumnar junction SIL squamous intraepithelial lesion STI sexually transmitted infection VIA visual inspection with acetic acid VILI visual inspection with Lugol’s iodine 3 PREFACE Cancer is being diagnosed more and more frequently in the developing world. The recent World Health Organization report, Preventing chronic diseases: a vital investment, projected that over 7.5 million people would die of cancer in 2005, and that over 70% of these deaths would be in low- and middle-income countries. The importance of the challenge posed by cancer was reiterated by the World Health Assembly in 2005, in Resolution 58.22 on Cancer Prevention and Control, which emphasized the need for comprehensive and integrated action to stop this global epidemic. Cervical cancer is the second most common type of cancer among women, and was responsible for over 250 000 deaths in 2005, approximately 80% of which occurred in developing countries. Without urgent action, deaths due to cervical cancer are projected to rise by almost 25% over the next 10 years. Prevention of these deaths by adequate screening and treatment (as recommended in this Guide) will contribute to the achievement of the Millennium Development Goals. Most women who die from cervical cancer, particularly in developing countries, are in the prime of their life. They may be raising children, caring for their family, and contributing to the social and economic life of their town or village. Their death is both a personal tragedy, and a sad and unnecessary loss to their family and their community. Unnecessary, because there is compelling evidence – as this Guide makes clear – that cervical cancer is one of the most preventable and treatable forms of cancer, as long as it is detected early and managed effectively. Unfortunately, the majority of women in developing countries still do not have access to cervical cancer prevention programmes. The consequence is that, often, cervical cancer is not detected until it is too late to be cured. An urgent effort is required if this situation is to be corrected. All women have a right to accessible, affordable and effective services for the prevention of cervical cancer. These services should be delivered as part of a comprehensive programme to improve sexual and reproductive health. Moreover, a concerted and coordinated effort is required to increase community awareness about screening for the prevention and detection of cervical cancer. A great deal of experience and evidence-based knowledge is available for the prevention (and treatment) of cervical cancer and related mortality and morbidity. However, until now, this information was not available in one easy-to-use guide. This publication – produced by WHO and its partners – is designed to provide comprehensive practical advice to health care providers at all levels of the health care system on how to prevent, detect early, treat and palliate cervical cancer. In particular, the Guide seeks to ensure that health care providers at the primary and secondary levels will be empowered to use the best available knowledge in dealing with cervical cancer for the benefit of the whole community. 4 We call on all countries that have not already done so to introduce effective, organized control programmes for cervical cancer as recommended in this Guide. Together, we can significantly reduce the heavy burden of this disease and its consequences. Catherine Le Gales-Camus Assistant Director-General Noncommunicable Diseases and Mental Health Joy Phumaphi Assistant Director-General Family and Community Health 5 INTRODUCTION ABOUT THE GUIDE Scope and objectives of the Guide This Guide is intended to help those responsible for providing services aimed at reducing the burden posed by cervical cancer for women, communities and health systems. It focuses on the knowledge and skills needed by health care providers, at different levels of care, in order to offer quality services for prevention, screening, treatment and palliation of cervical cancer. The Guide presents guidelines and up- to-date, evidence-based recommendations covering the full continuum of care. Key recommendations are included in each chapter; a consolidated list is given on pages 11–12. The four levels of care referred to throughout this Guide are: • the community; • the health centre or primary care level; • the district hospital or secondary care level; • the central or referral hospital or tertiary care level. A detailed description of each level is given on page 9. The Guide does not cover programme management, resource mobilization, or the political, legal and policy-related activities associated with cervical cancer control. Adaptation This Guide provides broadly applicable recommendations and may need to be adapted to local health systems, needs, language and culture. Information and suggestions on adaptation are available elsewhere (see list of additional resources). The Guide and its recommendations can also be used as a basis for introducing or adapting national protocols, and for modifying policies and practices. The target audience This Guide is intended primarily for use by health care providers working in cervical cancer control programmes in health centres and district hospitals in settings with limited resources. However, it may also be of interest to community and tertiary-level providers, as well as workers in other settings where women in need of screening or treatment might be reached. The health care team In an ideal cervical cancer control programme, providers work as a team, performing in a complementary and synergistic manner, and maintaining good communication within 6 and between levels. In some countries, the private and the nongovernmental sectors are important providers of services for cervical cancer. Providers in these sectors should be integrated in the health care team where relevant. Some possible roles of health care providers at different levels of the health care system are as follows: • Community health workers (CHWs) may be involved in raising awareness of cervical cancer in the community, motivating and assisting women to use services, and following up those who have been treated at higher levels of care when they return to their community. • Primary health care providers can promote services and conduct screening and follow-up, and refer women to higher levels as necessary. • District-level providers perform a range of diagnostic and treatment services, and refer patients to higher and lower levels of care. • Central-level providers care for patients with invasive and advanced disease, and refer them back to lower levels, when appropriate. Using the Guide This Guide can be used by health care providers, supervisors and trainers: • as a reference manual, providing basic, up-to-date information about prevention, screening, diagnosis and treatment of cervical cancer; • to design preservice and in-service education and training, and as a self-education tool; • as a review of prevention and management of cervical cancer; • to find evidence-based advice on how to handle specific situations; • to understand how the roles of different providers are linked with each other at the various levels of the health care system. The Guide can be used as a whole, or users can focus on the sections that are relevant to their practice. Even if it is used selectively, we strongly recommend that readers should review the recommendations appearing on pages 11–12 in their entirety. The contents The Guide is composed of seven chapters and associated practice sheets, nine annexes and a glossary. Each chapter includes: • a description of the role and responsibilities of first- and second-level providers in relation to the specific topic of the chapter; • a story illustrating and personalizing the topic of the chapter; 7 • essential background information on the subject of the chapter, followed by discussion of established and evolving practices in clinical care, and recommendations for practice, as appropriate; • information on services at each of the four levels of the health care system; • counselling messages to help providers communicate with women about the services they have received and the follow-up they will need; • a list of additional resources. Most of the chapters have associated practice sheets. These are short, self-contained documents containing key information on specific elements of care that health care providers may need to deliver, for example, how to take a Pap smear or how to perform cryotherapy. Counselling is included as an integral part of each procedure described. Practice Sheets 13–17 relate to procedures carried out by specialists. The information provided in these sheets can help other health care providers to explain the procedure to the patient, to counsel her, and to treat particular problems that may arise after the intervention. The practice sheets can be individually copied or adapted.1 The annexes detail specific practice components, using internationally established protocols (e.g. management flowcharts and treatment protocols) and strategies to enhance service quality (e.g. infection prevention). The glossary contains definitions of scientific and technical terms used in the Guide. Key principles and framework for this document Principles The approach of this Guide is based on the following principles: • the right of everyone to equitable, affordable and accessible health care; • reproductive health rights, as formulated in the Programme of Action adopted at the 1994 International Conference on Population and Development in Cairo (paragraph 7.6); • the ethical principles of justice, autonomy and beneficence as defined and discussed in the Declaration of Helsinki and the International Ethical Guidelines for Biomedical Research Involving Human Subjects prepared by the Council of International Organizations of Medical Sciences (CIOMS) and WHO; 1 The practice sheets are not intended to be used by a novice to learn how to carry out a procedure. They are intended as job aids, to remind trained providers of the essential steps and to help them to educate, counsel and correctly explain services to women and their families. They can also be used as a checklist to document competency as part of supportive supervision. 8 • a gender-based perspective: the discussion considers gender-related factors that may affect the power balance between men and women, reduce women’s power of self-determination, and affect the provision and receipt of services. Underlying framework The following assumptions and context underlie the presentation of material in this Guide: • All the interventions recommended are based on sound scientific evidence. • Comprehensive control of cervical cancer should be undertaken in the context of a national cancer control programme (NCCP). • Cervical cancer control should, as far as possible, be integrated into existing sexual and reproductive health services at the primary health care level. • Screening and early diagnosis will lead to reduced morbidity and mortality only if they are integrated with follow-up and management of all preinvasive lesions and invasive cancers detected. • Resources are available or will be developed to strengthen health infrastructure, and make available the following: – well trained providers; – necessary equipment and supplies; – a functional referral system and communication between different teams, services, health system levels and the community; – a quality assurance system. The Guide’s development Evidence for the information in the Guide is based on the following: • a review of the relevant literature; • input from a Technical Advisory Group (TAG), consisting of experts in different disciplines from developing and developed countries, who elaborated and reviewed the Guide; • extensive written review of drafts by a large number of external experts; • review by WHO staff; • information provided by the International Agency for Research on Cancer (IARC), including the handbook, Cervix cancer screening, published in 2005; • in-country review (pre-field-testing) in six countries. The evidence base for all the guidance presented in this Guide will be published separately as a companion document. 9 LEVELS OF THE HEALTH CARE SYSTEM 2 COMMUNITY LEVEL Includes individuals and organizations; community-based, faith-based and other nongovernmental organizations; and community and home-based palliative care services. Also included are health posts or “cases de santé”, usually staffed by an auxiliary nurse or community health worker. HEALTH CENTRE – PRIMARY CARE LEVEL Refers to primary care facilities with trained staff and regular working hours. Maternity and minimal laboratory services may be available. Providers at this level include nurses, auxiliary nurses or nursing assistants, counsellors, health educators, medical assistants, clinical officers and, sometimes, physicians. DISTRICT HOSPITAL – SECONDARY CARE LEVEL Typically, a hospital that provides general medical, paediatric, and maternity services, limited surgical care, inpatient and outpatient care, and, sometimes, intermittent specialized care. Patients may be referred from health centres and private practitioners in the district. Laboratory services may include cytology and histopathology. Providers include generalist physicians or clinical officers, nurses, pharmacy technicians or dispensing clerks, medical assistants, nurse assistants, and laboratory technology assistants, possibly a gynaecologist and a cytotechnologist. Private and mission hospitals are often present at this level. CENTRAL OR REFERRAL HOSPITAL – TERTIARY CARE LEVEL Tertiary care hospitals provide general and specialized care for complex cases and acutely ill patients, including surgery, radiotherapy and multiple outpatient and inpatient services. General medical, acute and chronic care clinics are offered. The most complete public-sector diagnostic and reference laboratory services are available with pathologists and cytotechnologists, radiology, and diagnostic imaging. Providers may include gynaecologists, oncologists and radiotherapists, as well as those present at lower levels of care. In the community At the health centre At the district hospital At the central hospital 2 This description does not include services and providers outside the formal health system: traditional healers, traditional birth attendants, medicine sellers, etc., who also play important roles. 10 ESSENTIAL READING • Alliance for Cervical Cancer Prevention. Planning and implementing cervical cancer prevention programs: a manual for managers. Seattle, WA, 2004. • IARC. Cervix cancer screening. Lyon, IARCPress, 2005 (IARC Handbooks of Cancer Prevention, Vol. 10). • WHO. Cervical cancer screening in developing countries. Report of a WHO Consultation. Geneva, 2002. • WHO. Comprehensive cervical cancer control. A guide for essential practice, evidence base. Geneva (in preparation). • Alliance for Cervical Cancer Prevention (www.alliance-cxca.org). • International Agency for Research on Cancer (www.iarc.fr). • Program for Appropriate Technology in Health (www.path.org). • EngenderHealth (www.engenderhealth.org). • JHPIEGO (www.JHPIEGO.org). • Cancer prevention and control. Resolution 58.22 of the 58th World Health Assembly (www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_22-en.pdf). • WHO Cancer Control Programme (www.who.int/cancer). • WHO Department on Reproductive Health and Research (www.who.int/reproductive- health). 11 WHO RECOMMENDATIONSWHO RECOMMENDATIONS • Health education should be an integral part of comprehensive cervical cancer control. • Cytology is recommended for large-scale cervical cancer screening programmes, if sufficient resources exist. Recommended target ages and frequency of cervical cancer screening: – New programmes should start screening women aged 30 years or more, and include younger women only when the highest-risk group has been covered. Existing organized programmes should not include women less than 25 years of age in their target populations. – If a woman can be screened only once in her lifetime, the best age is between 35 and 45 years. – For women over 50 years, a five-year screening interval is appropriate. – In the age group 25-49 years, a three-year interval can be considered if resources are available. – Annual screening is not recommended at any age. – Screening is not necessary for women over 65 years, provided the last two previous smears were negative. • Visual screening methods (using acetic acid (VIA) or Lugol’s iodine (VILI)), at this time, are recommended for use only in pilot projects or other closely monitored settings. These methods should not be recommended for postmenopausal women. • Human papillomavirus (HPV) DNA tests as primary screening methods, at this time, are recommended for use only in pilot projects or other closely monitored settings. They can be used in conjunction with cytology or other screening tests, where sufficient resources exist. HPV DNA-based screening should not begin before 30 years of age. • There is no need to limit the use of hormonal contraceptives, despite the small increased risk of cervical cancer noted with use of combined oral contraceptives. • Women should be offered the same cervical cancer screening and treatment options irrespective of their HIV status. • Colposcopy is recommended only as a diagnostic tool and should be performed by properly trained and skilled providers. continued next page 12 • Precancer should be treated on an outpatient basis whenever possible. Both cryotherapy and the loop electrosurgical excision procedure (LEEP) may be suitable for this purpose, depending on eligibility criteria and available resources. • Histological confirmation of cervical cancer and staging must be completed before embarking on further investigations and treatment. • Surgery and radiotherapy are the only recommended primary treatment modalities for cervical cancer. • Brachytherapy is a mandatory component of curative radiotherapy of cervical cancer. • Surgery for treatment of cervical cancer should be performed only by surgeons with focused training in gynaecological cancer surgery. • The needs of women with incurable disease should be addressed by using existing palliative care services or establishing new ones. Providers at all care levels need to be trained and must have the resources necessary to manage the most common physical and psychosocial problems, with special attention to pain control. • A comprehensive cervical cancer programme should ensure that opioid, non- opioid and adjuvant analgesics, particularly morphine for oral administration, are available. 13 1 CHAPTER 1: BACKGROUND 14 15Chapter 1: Background Chapter 1: Background 1 CHAPTER 1: BACKGROUND Key points • Cervical cancer is one of the leading causes of cancer death in women in the developing world. • The primary underlying cause of cervical cancer is infection with human papillomavirus (HPV), a very common virus that is sexually transmitted. • Most HPV infections resolve spontaneously; those that persist may lead to the development of precancer and cancer. • It usually takes 10 to 20 years for precursor lesions caused by HPV to develop into invasive cancer. • Effective interventions against cervical cancer exist, including screening for, and treatment of, precancer and invasive cancer. • An estimated 95% of women in developing countries have never been screened for cervical cancer. • Over 80% of women newly diagnosed with cervical cancer live in developing countries; most are diagnosed when they have advanced disease. • The cure rate for invasive cervical cancer is closely related to the stage of disease at diagnosis and the availability of treatment. If left untreated, cervical cancer is almost always fatal. • Because of its complexity, cervical cancer control requires a team effort and communication between health care providers at all levels of the health care system. ABOUT THIS CHAPTER Cancer control programmes can go a long way in preventing cervical cancer and reducing its morbidity and mortality. This chapter explains why organized cervical cancer control programmes are urgently needed. It outlines the burden that the disease places on women and on health services, summarizing global statistics and describing regional and intracountry inequities. The chapter also describes essential elements of successful programmes, including the rationale for selection of the target group for screening, as well as barriers to their implementation, concluding that cancer control needs to be based on a constant team effort. 16 Chapter 1: Background Chapter 1: Background 1 WHY FOCUS ON CERVICAL CANCER? In 2005, there were, according to WHO projections, over 500 000 new cases of cervical cancer, of which over 90% were in developing countries. It is estimated that over 1 million women worldwide currently have cervical cancer, most of whom have not been diagnosed, or have no access to treatment that could cure them or prolong their life. In 2005, almost 260 000 women died of the disease, nearly 95% of them in developing countries, making cervical cancer one of the gravest threats to women’s lives. In many developing countries, access to health services is limited and screening for cervical cancer either is non-existent or reaches few of the women who need it. In these areas, cervical cancer is the most common cancer in women and the leading cause of cancer death among women. The primary underlying cause of cervical cancer is infection with one or more high-risk types of the human papillomavirus (HPV), a common virus that is sexually transmitted. Most new HPV infections resolve spontaneously; if it persists, infection may lead to the development of precancer which, left untreated, can lead to cancer. As it usually takes 10–20 years for precursor lesions caused by HPV to develop into invasive cancer, most cervical cancers can be prevented by early detection and treatment of precancerous lesions. Experience in developed countries has shown that well planned, organized screening programmes with high coverage can significantly reduce the number of new cases of cervical cancer and the mortality rate associated with it. There is also evidence that general awareness about cervical cancer, effective screening programmes, and the improvement of existing health care services can reduce the burden of cervical cancer for women and for the health care system. There is a huge difference in the incidence of, and mortality from, cervical cancer between developed and developing countries, as shown in Figures 1.1 and 1.2. The main reasons for the higher incidence and mortality in developing countries are: • lack of awareness of cervical cancer among the population, health care providers and policy-makers; • absence or poor quality of screening programmes for precursor lesions and early-stage cancer. In women who have never been screened, cancer tends to be diagnosed in its later stages, when it is less easily treatable; • limited access to health care services; • lack of functional referral systems. The difference between developed and developing countries reflects stark inequalities in health status, and represents a challenge for health services. Figure 1.1 Age-standardized Incidence rates of cervical cancer in developed and Figure 1.1 Age-standardized Incidence rates of cervical cancer in developed and developing countries (2005)developing countries (2005) Source: WHO. Preventing chronic diseases: a vital investment. Geneva, 2005. Figure 1.2 Age-standardized mortality rates of cervical cancer in developed and Figure 1.2 Age-standardized mortality rates of cervical cancer in developed and developing countries (2005)developing countries (2005) ra te s pe r 1 00 0 00 w om en a ge groups 15–44 45–69 70+ 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 Developed countries Developing countries age groups Source: WHO. Preventing chronic diseases: a vital investment. Geneva, 2005. ra te s pe r 1 00 0 00 w om en 15–44 45–69 70+ 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 Developed countries Developing countries 17Chapter 1: Background Chapter 1: Background 1 18 Chapter 1: Background Chapter 1: Background 1 WHO IS MOST AFFECTED BY CERVICAL CANCER? Cervical cancer is rare in women under 30 years of age and most common in women over 40 years, with the greatest number of deaths usually occurring in women in their 50s and 60s. Cervical cancer occurs worldwide, but the highest incidence rates are found in Central and South America, eastern Africa, South and South-East Asia, and Melanesia. Figure 1.3 shows the global incidence of cervical cancer. Over the past three decades, cervical cancer rates have fallen in most of the developed world, probably as a result of screening and treatment programmes. In contrast, rates in most developing countries have risen or remained unchanged. Inequalities also exist in the developed world, where rural and poorer women are at greatest risk of invasive cervical cancer. Left untreated, invasive cervical cancer is almost always fatal, causing enormous pain and suffering for the individual and having significant adverse effects on the welfare of their families and communities. Figure 1.3 Worldwide incidence rates of cervical cancer per 100,000 females (all ages), Figure 1.3 Worldwide incidence rates of cervical cancer per 100,000 females (all ages), age-standardised to the WHO standard population (2005)age-standardised to the WHO standard population (2005) <8.0 8.0 – 14.9 15.0– 29.9 30.0– 44.9 >45.0 Legend 19Chapter 1: Background Chapter 1: Background 1 BARRIERS TO CONTROL OF CERVICAL CANCER A number of countries have implemented cervical cancer control programmes in recent decades; some of these have produced significant decreases in incidence and mortality, while others have not. Among the reasons for failure are the following: • Political barriers: – lack of priority for women’s sexual and reproductive health; – lack of national policies and appropriate guidelines. • Community and individual barriers: – lack of awareness of cervical cancer as a health problem; – attitudes, misconceptions and beliefs that inhibit people discussing diseases of the genital tract. • Economic barriers (lack of resources). • Technical and organizational barriers, caused by poorly organized health systems and weak infrastructure. Lack of priority for women’s health The lack of priority given to women’s health needs, particularly those not related to maternity and family planning, was a focus of the International Conference on Population and Development, held in Cairo in 1994. At this Conference, countries made strong commitments to reframe women’s health in terms of human rights and to promote an integrated vision of reproductive health care. Significant advances have occurred in some areas, but cervical cancer has still not received sufficient attention in many countries, despite its high incidence, morbidity and mortality. Lack of evidence-based national guidelines National guidelines for cervical cancer control may not exist or may not reflect recent evidence and local epidemiological data. Generic guidelines, available in the literature, are often not used or not adapted to local needs. In many programmes, scarce resources are wasted in screening young women attending family planning and antenatal clinics, and in screening more frequently than necessary. Resources would be better used to reach older women, who are at greater risk and who generally do not attend health services. Poorly organized health systems and infrastructure A well functioning health system, with the necessary equipment and trained providers, is essential for prevention activities, screening, diagnosis, linkages for follow-up and treatment, and palliative care. 20 Chapter 1: Background Chapter 1: Background 1 Lack of awareness In many places, cervical cancer has been ignored by decision-makers, health care providers and the population at large. Decision-makers may not be aware of the tremendous burden of disease and magnitude of the public health problem caused by this cancer. Providers may lack accurate information on its natural history, detection and treatment. Many women and men have not heard of cervical cancer and do not recognize early signs and symptoms when they occur. Women at risk may not be aware of the need to be tested, even when they do not have any symptoms. Attitudes, misconceptions and beliefs Attitudes and beliefs about cervical cancer among the general population and health care providers can also present barriers to its control. Cancer is often thought to be an untreatable illness, leading inevitably to death. In addition, the female genital tract is often considered private and women may be shy about discussing symptoms related to it. This is especially true in settings where the health care provider is a man, or is from a different culture. Destigmatizing discussion of the female genital tract may be an important strategy in encouraging women to be screened and to seek care if they have symptoms suggestive of cervical cancer. Lack of resources In the vast majority of settings where competition for limited funds is fierce, cervical cancer has remained low on the agenda. In these settings, cervical cancer is often not considered a problem or a funding priority. THE FOUR COMPONENTS OF CERVICAL CANCER CONTROL Within a national cancer control programme, there are four basic components of cervical cancer control: • primary prevention; • early detection, through increased awareness and organized screening programmes; • diagnosis and treatment; • palliative care for advanced disease. Primary prevention means prevention of HPV infection and cofactors known to increase the risk of cervical cancer, and includes: • education and awareness-raising to reduce high-risk sexual behaviours; • implementation of locally appropriate strategies to change behaviour; 21Chapter 1: Background Chapter 1: Background 1 • the development and introduction of an effective and affordable HPV vaccine; • efforts to discourage tobacco use, including smoking (which is a known risk factor for cervical and other cancers). Early detection includes: • organized screening programmes, targeting the appropriate age group and with effective links between all levels of care; • education for health care providers and women in the target group, stressing the benefits of screening, the age at which cervical cancer most commonly occurs, and its signs and symptoms. Diagnosis and treatment includes: • follow-up of patients who are positive on screening, to ensure that a diagnosis is made and the disease appropriately managed; • treatment of precancer, using relatively simple procedures, to prevent the development of cancer; • treatment of invasive cancer, including surgery, radiotherapy and chemotherapy. Palliative care includes: • symptomatic relief for bleeding, pain and other symptoms of advanced cancer and for the side-effects caused by some treatments; • compassionate general care for women whose cancer cannot be cured; • involvement of the family and the community in caring for cancer patients. Cervical cancer control can be achieved if: • A national policy on cervical cancer control exists, based on the natural history of the disease and on local prevalence and incidence in different age groups. • Financial and technical resources are allocated to support the policy. • Programmes of public education and advocacy for prevention are in place to support national policies. • Screening is organized, rather than opportunistic, and follow-up and quality control are assured (see Chapter 4). • The largest possible number of women in the target group are screened. • Screening services are linked to treatment of precancer and invasive cancer. • A health information system is in place to monitor achievements and identify gaps. 22 Chapter 1: Background Chapter 1: Background 1 A TEAM APPROACH TO CERVICAL CANCER CONTROL Because of its complexity, cervical cancer control requires a multidisciplinary team effort and communication between providers at all levels of the health care system. • Community health workers (CHWs) need to communicate with nurses and physicians from primary health care settings, and sometimes with laboratory personnel and specialists at the district and central levels. • Communication within and between health facilities, and links with community- based workers, are essential to coordinate services, to give women the best possible care, and to improve outcomes. Two-way communication is particularly important for the management of women with invasive cancer, who are treated in hospital and then return to the community to recover or to be cared for. • Secondary and tertiary care providers, such as surgeons, radiotherapists and nurses, need to communicate in plain language with primary care providers and CHWs. It can be helpful, for example, for central hospital-based physicians to go to communities from time to time to talk with CHWs and to see for themselves the problems in low-resource settings of caring for women who have been treated for cancer. • Facility managers and supervisors can foster links by communicating with providers, and by monitoring and improving the quality of the existing system. • Managers must ensure that supplies are available and that there are adequate incentives for good work. • The cervical cancer control team must obtain the support and commitment of regional and national decision-makers. Tips for building a team • Ensure good communication between team members through regular meetings where information is exchanged and staff can air and solve work-related problems. • Foster mutual trust and caring among staff, including supervisors, to stimulate genuine interest in each other. • Keep motivation high by providing training and support, with regular updates, supervision and mentoring. • Ensure a pleasant, clean, safe work environment, with adequate supplies and staffing. • Reward staff adequately for their work. 23Chapter 1: Background Chapter 1: Background 1 ADDITIONAL RESOURCES • Alliance for Cervical Cancer Prevention. Planning and implementing cervical cancer prevention programs: a manual for managers. Seattle, WA, 2004. • Alliance for Cervical Cancer Prevention Website: www.alliance-cxca.org. • International Agency for Research on Cancer Website: www.iarc.fr. • World Bank. World development indicators 2003. Washington, DC, 2003. • World Health Organization. National cancer control programmes, 2nd ed. Geneva, 2002. 24 25 2 CHAPTER 2: ANATOMY OF THE FEMALE PELVIS AND NATURAL HISTORY OF CERVICAL CANCER 26 Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 27 CHAPTER 2: ANATOMY OF THE FEMALE PELVIS AND NATURAL HISTORY OF CERVICAL CANCER Key points • Basic knowledge of the anatomy of the female pelvis and the natural history of cervical cancer is essential for understanding the disease and communicating messages about prevention, screening, treatment and care. • The cervix undergoes normal changes from birth until after the menopause. • The cervical transformation zone is the area where the great majority of precancers and cancers arise. • The transformation zone is larger during puberty and pregnancy and in women who have used oral contraceptives (OCs) for a long time, which may increase exposure to HPV. This may explain why early sexual activity, multiple pregnancies and, to a lesser extent, long-term use of OCs, are cofactors for the later development of cervical cancer. • After the menopause, the transformation zone may extend into the inner cervical canal, requiring the use of an endocervical speculum to see it completely. • From the time that mild dysplasia is identified, it usually takes 10 to 20 years for invasive cancer to develop; this means that cervical cancer control is possible through screening and treatment. • HPV infection is a necessary, but not a sufficient, cause of cervical cancer; host factors, as well as behavioural and environmental factors, may facilitate cancer development. ABOUT THIS CHAPTER The natural history of cervical cancer, with its usually slow progression from early precancer to invasive disease, provides the rationale for screening, early detection and treatment. To understand how cervical precancer and cancer develop and progress, it is necessary to have a basic understanding of female pelvic anatomy, including the blood vessels, lymphatic drainage systems and nerve supply. This chapter describes the pelvic anatomy, and contains additional information for non-specialists on normal and abnormal changes that occur in the cervix and how these relate to screening and treatment for precancer and cancer. With this understanding, health care providers will be able to communicate accurate information on cervical cancer prevention, screening and management to women, patients, and their families. Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 28 ANATOMY AND HISTOLOGY This section describes the female pelvic anatomy, the covering layers of the cervix or epithelia, and the normal physiological changes that take place during a woman’s life cycle, and identifies the area most likely to develop precancerous abnormalities. Female pelvic anatomy An understanding of the anatomy of the female pelvic structures will help providers involved in cervical cancer programmes to: • perform their tasks, including screening and diagnosis; • interpret laboratory and treatment procedure reports and clinical recommendations received from providers at higher levels of the health care system; • educate patients and families on their condition and plan for their follow-up; • communicate effectively with providers at other levels of care. The external genitalia Figure 2.1 Female external genitaliaFigure 2.1 Female external genitalia As seen in Figure 2.1, the external genitalia include the major and minor labia, the clitoris, the urinary opening (urethra), and the vaginal opening or introitus. The area between the vulva and the anus is called the perineum. Bartholin glands are two small bodies on either side of the introitus. minor labia major labia bartholin glands clitoris urethra vaginal introitus perineum anus Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 29 The internal organs As shown in Figure 2.2, the vagina and uterus lie behind and above the pubic bone in the pelvis. The urinary bladder and urethra are in front of the vagina and uterus, and the rectum is behind them. The ureters (small tubes that deliver urine from the kidney to the bladder) lie close to the cervix on each side. Figure 2.2 Front and side view of female internal organsFigure 2.2 Front and side view of female internal organs ovary endometrium endocervix vagina uterus urinary bladder pubic bone urethra vagina sacrum rectum cervix vulva fallopian tube uterus ectocervix Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 30 The vagina The vagina is an elastic fibromuscular tube leading from the introitus to the cervix; its walls form multiple folds, allowing it to expand during sexual activity and childbirth. The walls of the vagina are normally in contact with each other. The lower portion of the cervix (ectocervix) protrudes into the upper end of the vagina and the vaginal area surrounding it comprises the anterior, posterior and lateral fornices. The uterus and cervix The uterus or womb is a thick-walled, pear-shaped, hollow organ made of smooth muscle. It is supported by several connective tissue structures: transverse ligaments, uterosacral ligament and broad ligament (a fold in the peritoneum spanning the area between the uterus and the side walls of the bony pelvis which enfolds the fallopian tubes and round ligaments within it). The ovaries are attached to the back of the broad ligament. The cavity of the uterus is lined by the endometrium, a glandular epithelium which goes through dramatic changes with the menstrual cycle. When not enlarged by pregnancy or tumours, the uterus measures approximately 10 centimetres from its top (fundus) to the bottom of the cervix. The cervix is the lower one-third of the uterus and is composed of dense, fibromuscular tissue (Figure 2.3) lined by two types of epithelium (see below). It is about 3 cm in length and 2.5 cm in diameter. The lower part of the cervix (outer cervix or ectocervix) lies within the vagina and is visible with a speculum; the upper two-thirds (inner cervix or endocervix) lies above the vagina. The cervical canal runs through the centre of the cervix from the internal os (opening) leading into the uterine cavity to the external os, which can be seen in the centre of the cervix on speculum examination. The external os is seen as a small round opening in nulliparous women and as a wide, mouth-like, irregular slit in women who have given birth. The lower portion of the endocervical canal can be visualized using an endocervical speculum. Figure 2.3 Uterus of a woman of reproductive ageFigure 2.3 Uterus of a woman of reproductive age endocervix cervical canal external os ectocervix internal os fundus 7 cm corpus 3 cm cervix vagina Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 31 The blood and lymph vessels The arteries that supply the uterus and cervix derive from the internal iliac arteries and their uterine, cervical and vaginal branches. The cervical branches descend along the length of the cervix at the 3 and 9 o’clock positions. It is important to keep this in mind when injecting local anaesthetic, in order to avoid injecting into the artery. The veins draining the cervix run parallel to the arteries. The lymph nodes and ducts draining the pelvic organs lie close to the blood vessels and may act as a pathway for the spread of cervical cancer. In late stages of cancer, large tumours may block lymphatic drainage and cause the legs to swell (lymphoedema). The nerves The ectocervix has no pain nerve endings; thus, procedures involving only this area (biopsy, cryotherapy) are well tolerated without anaesthesia. The endocervix, on the other hand, is rich in sensory nerve endings, and is sensitive to painful stimuli, injury and stretching. Networks of nerve fibres are found around the cervix and extend to the body of the uterus. A paracervical block, to produce local anaesthesia for certain procedures, is performed by injecting anaesthetic at various points between the cervical epithelium and the vaginal tissue. Because sympathetic and parasympathetic nerves are also present, procedures involving the endocervical canal (such as insertion of an endocervical curette) may sometimes cause a vasovagal reaction (sweating, slow heart rate and fainting). The cervical epithelia The surface of the cervix is lined by two types of epithelium: squamous epithelium and columnar epithelium (Figure 2.4). Figure 2.4 The two types of cervical epithelium and the squamocolumnar junction (SCJ)Figure 2.4 The two types of cervical epithelium and the squamocolumnar junction (SCJ) Adapted from: Sellors JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners’ manual. Lyon, France, IARCPress, 2002. squamous epithelium SCJ columnar epithelium basement membrane Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 32 Figure 2.5 The transformation zone of the cervix of a parous woman of reproductive age Figure 2.5 The transformation zone of the cervix of a parous woman of reproductive age Source: Sellors JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners’ manual. Lyon, France, IARCPress, 2002. The stratified squamous epithelium is a multilayered epithelium of increasingly flatter cells. It normally covers most of the ectocervix and vagina and, in premenopausal women, appears pale pink and opaque. Its lowest (basal) layer, composed of rounded cells, is attached to the basement membrane, which separates the epithelium from the underlying fibromuscular stroma. In postmenopausal women, the squamous epithelium has fewer layers of cells, appears whitish-pink, and is prone to trauma, which is often visible as small haemorrhages or petechiae. The columnar epithelium lines the cervical canal and extends outwards to a variable portion of the ectocervix. It consists of a single layer of tall cells sitting on the basement membrane. This layer is much thinner than the squamous lining of the ectocervix. When seen with an endocervical speculum, it appears shiny red. The original squamocolumnar junction (SCJ) appears as a sharp line, with a step produced by the different thicknesses of the columnar and squamous epithelia. The location of the original SCJ varies with the woman’s age, hormonal status, history of birth trauma, pregnancy status, and use of oral contraceptives (Figures 2.5 and 2.6). Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 33 Squamous metaplasia and the transformation zone When exposed to the acidic environment of the vagina, the columnar epithelium is gradually replaced by stratified squamous epithelium, with a basal layer of polygonal- shaped cells derived from the original columnar cells. This normal replacement process is termed squamous metaplasia and gives rise to a new SCJ. When mature, the new squamous epithelium closely resembles the original squamous epithelium. However, the newly formed SCJ and the original SCJ are distinct on examination. The transformation zone is the area between the original and the new SCJ, where the columnar epithelium is being or has been replaced by squamous epithelium (Figures 2.5 and 2.6). Development of precancer and cancer The stratified squamous epithelium covering the cervix provides protection from toxic substances and infection. Under normal circumstances, the top layers are continually dying and sloughing off, and the integrity of the lining is maintained by the constant, orderly formation of new cells in the basal layer. However, in the presence of persistent HPV infection and other cofactors, the metaplastic squamous cells of the transformation zone take on an abnormal appearance, cervical squamous precancer (dysplasia). These cells later multiply in a disorderly manner typical of cancerous change to produce squamous cell carcinoma. During puberty and pregnancy, and in women using oral contraceptives, the transformation zone on the ectocervix is enlarged. Exposure to HPV at such times may facilitate infection, which may explain the association between squamous cell cervical cancer and early sexual activity, multiple pregnancies and, to a lesser extent, long-term use of oral contraceptives. Ninety per cent of cervical cancer cases are squamous cell carcinomas arising from the metaplastic squamous epithelium of the transformation zone; the other 10% are cervical adenocarcinomas arising from the columnar epithelium of the endocervix. Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 34 a. From birth to prepuberty: The original squamocolumnar junction is present in girls at birth, and is found at or near the external os. b. From menarche to early reproductive age: At puberty when the ovaries begin to secrete estrogen, the cervix grows in size, columnar cells from the endocervix and the original SCJ become visible on the outer cervix. c. In women in their 30s: Under the influence of estrogen, the normal maturing process, known as squamous metaplasia, takes place, and both original and new SCJs are visible. d. In perimenopausal women: As women age and the influence of estrogen decreases around menopause, the cervix shrinks, and the columnar epithelium and transformation zone retreat back from the outer cervix into the endocervical canal. e. In postmenopausal women: Without estrogen stimulation, the original SCJ is still visible on speculum examination, but the new SCJ and a variable portion of the metaplastic epithelium of the transformation zone have retreated into the cervical canal. Adapted from: Sellors JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners’ manual. Lyon, France, IARCPress, 2002. Figure 2.6 The process of squamous metaplasiaFigure 2.6 The process of squamous metaplasia Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 35 NATURAL HISTORY OF CERVICAL CANCER What is cancer? Cancer is a term used for the malignant, autonomous and uncontrolled growth of cells and tissues. Such growth forms tumours, which may invade surrounding and distant parts of the body, destroying normal tissues and competing for nutrients and oxygen. Metastases occur when small groups of cells become detached from the original tumour, are carried to distant sites via the blood and lymph vessels, and start new tumours similar to the original one. The development of cervical cancer The primary cause of squamous cervical cancer is persistent or chronic infection with one or more of the so-called high-risk or oncogenic types of human papillomavirus. The most common cancer-causing types are 16 and 18, which are found in 70% of all cervical cancers reported. Other oncogenic types (e.g. 31, 33, 45, and 58) are found less commonly and may have different prevalence in different geographical areas. Low-risk HPV types 6 and 11 are not associated with cancer, but cause genital warts. The key determinants of HPV infection for both men and women are related to sexual behaviour, and include young age at sexual initiation, a high number of sexual partners, and having partners with multiple partners. High-risk HPV infection is most common in young women, with a peak prevalence as high as 25–30% in women under 25 years of age. In most sites, prevalence decreases sharply with age. While infection with a high-risk HPV is the underlying cause of cervical cancer, most women infected with high-risk HPV do not develop cancer. Most cervical HPV infections, regardless of type, are short-lived, with only a small number persisting and even fewer progressing to precancerous lesions or invasive cancer. The conditions or cofactors that lead HPV infection to persist and progress to cancer are not well understood, but the following probably play a role. • HPV-related cofactors: – viral type; – simultaneous infection with several oncogenic types; – high amount of virus (high virus load). Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 36 • Host-related cofactors – immune status: people with immunodeficiency (such as that caused by HIV infection) have more persistent HPV infections and a more rapid progression to precancer and cancer; – parity: the risk of cervical cancer increases with higher parity. • Exogenous cofactors: – tobacco smoking; – coinfection with HIV or other sexually transmitted agents such as herpes simplex virus 2 (HSV-2), Chlamydia trachomatis and Neisseria gonorrhoeae; – long-term (> 5 years) use of oral contraceptives. This last cofactor is of particular concern since limiting the use of oral contraceptives could have far-reaching effects on women’s choice of contraceptive and hence on the rates of unwanted pregnancy, unsafe abortion and maternal mortality. A WHO expert group, convened to examine the evidence and formulate recommendations, concluded that all methods of contraception, including OCs, carry risks and benefits. With respect to cervical cancer, the benefits of OCs outweigh the risks, because the number of cervical cancers that result from their use is likely to be very small; therefore, women who choose to use OCs should not be prevented or discouraged from doing so. RECOMMENDATION RECOMMENDATION There is no need to limit the use of hormonal contraceptives, despite the small increased risk of cervical cancer noted with use of combined oral contraceptives. Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 37 Natural history of precancer During early adolescence and first pregnancy, when squamous metaplasia is occurring, infection with HPV may induce changes in the newly transformed cells, with viral particles being incorporated into the DNA of the cells. If the virus persists, it may cause precancerous and, later, cancerous changes by interfering with the normal control of cell growth (Figures 2.7 and 2.8). Estimates of the time it takes for cancer to develop from HPV infection vary. Sixty per cent or more of cases of mild dysplasia resolve spontaneously and only about 10% progress to moderate or severe dysplasia within 2–4 years; in some cases, moderate or severe dysplasia may occur without an earlier detectable mild dysplasia stage. Less than 50% of cases of severe dysplasia progress to invasive carcinoma, with much lower rates seen in younger women. The usual 10–20-year natural history of progression from mild dysplasia to carcinoma makes cervical cancer a relatively easily preventable disease and provides the rationale for screening. Figure 2.7 Natural history of cervical cancerFigure 2.7 Natural history of cervical cancer CIN: cervical intraepithelial lesion Adapted from: Cervix cancer screening. Lyon, IARCPress, 2005 (IARC Handbooks of Cancer Prevention, Vol. 10). Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 38 Figure 2.8 Progress from normal epithelium to invasive cancerFigure 2.8 Progress from normal epithelium to invasive cancer CIN: cervical intraepithelial lesion Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 39 Precancer classification systems There are many systems in use in different parts of the world for classifying and naming precancerous conditions of the cervix, based on cytology and histology (Table 2.1). Some are more useful than others because they incorporate knowledge of the disease’s natural history acquired over the past few decades. The classification system of cervical intraepithelial neoplasia (CIN) evolved in 1968, to take into account the different natural histories seen with different degrees of dysplasia. It is still used in many countries for cytological reports, although strictly speaking it should only be used for histological reports (results of microscopic examination of tissue samples). The Bethesda system was developed in the 1990s at the United States National Cancer Institute. In this system, which should be used only for cytological reports, CIN 2 and 3 are combined into one group, termed high-grade squamous intraepithelial lesions (HSIL). Cytologically (i.e. on microscopic examination of a smear), it is difficult, if not impossible, to distinguish CIN 2 and 3. In the 2001 Bethesda classification, atypical cells are divided into ASC-US (atypical squamous cells of undetermined significance) and ASC-H (atypical squamous cells: cannot exclude a high-grade squamous epithelial lesion). This classification is recommended by WHO for cytological reports. Table 2.1 Cervical precancer: different terminologies used for cytological and histological Table 2.1 Cervical precancer: different terminologies used for cytological and histological reporting reporting Cytological classification (used for screening) Histological classification (used for diagnosis) Pap Bethesda system CIN WHO descriptive classifications Class I Normal Normal Normal Class II ASC-US ASC-H Atypia Atypia Class III LSIL CIN 1 including flat condyloma Koilocytosis Class III HSIL CIN 2 Moderate dysplasia Class III HSIL CIN 3 Severe dysplasia Class IV HSIL CIN 3 Carcinoma in situ Class V Invasive carcinoma Invasive carcinoma Invasive carcinoma CIN: cervical intraepithelial neoplasia; LSIL: low-grade squamous intraepithelial lesion; HSIL: high-grade squamous intraepithelial lesion; ASC-US: atypical squamous cells of undetermined significance; ASC-H: atypical squamous cells: cannot exclude a high-grade squamous epithelial lesion. Bethesda System Annex 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 40 How often are screening abnormalities found? The number of precancerous lesions found in a population depends on: • the frequency of disease in the population; • the age group screened (for example, if many young women are screened, more LSIL will be found); • the previous screening status of the women (if women are screened regularly, less HSIL will be found); • the prevalence of HIV in the screened population (more precancerous lesions are found when HIV prevalence is high). In a previously unscreened population of women aged between 25 and 65 years, the following percentages of abnormal results are likely: • LSIL: 3–10%; • HSIL: 1–5%; • invasive cancer: 0.2–0.5%. Natural history of invasive cervical cancer Invasive cervical cancer is defined by the invasion of abnormal cells into the thick fibrous connective tissue underlying the basement membrane. It starts with a microinvasive stage, which is not visible with the naked eye on speculum examination and has to be diagnosed histologically, using a tissue sample from a cone biopsy or hysterectomy. It then evolves into larger lesions, which may extend to the vagina, pelvic walls, bladder, rectum and distant organs. If left untreated, cervical cancer progresses in a predictable manner and will almost always lead to death. The International Federation of Gynecology and Obstetrics (FIGO) system is often used to describe the extent of cancer invasion and to select treatment options (see Chapter 6). There are four, usually sequential, routes through which invasive cancer progresses. The disease is generally confined to the pelvis for a long period, where it is accessible to treatment. 1. Within the cervix. Spread from a tiny focus of microinvasive cancer, eventually involving the entire cervix which can enlarge to 8 cm or more in diameter. The cancer can be ulcerating, exophytic (growing outwards) or infiltrating (invading inwards). 2. To adjacent structures. Direct spread in all directions is possible: downwards to the vagina, upwards into the uterus, sideways into the parametrium (the tissues supporting the uterus in the pelvis) and the ureters, backwards to the rectum, and forwards to the bladder. Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 41 3. Lymphatic. Spread to pelvic lymph nodes occurs in 15% of cases when the cancer is still confined to the cervix, and increases as the cancer spreads. Lymph node metastases are at first confined to the pelvis and are later found in the chain of nodes along the aorta, eventually reaching the supraclavicular fossa (the space above the collar bone). If the cancer has advanced into the lower third of the vagina, the groin nodes may become involved and will be palpably enlarged. 4. Distant metastases through the bloodstream and lymph channels. Cervical cancer cells may spread through the blood stream and lymphatic system to develop distant metastases in the liver, bone, lung and brain. Cervical cancer and human immunodeficiency virus infection Immunosuppression, resulting from HIV infection or other causes (e.g. use of antirejection drugs after transplantation), presents particular problems. HIV-infected women have: • a higher prevalence of HPV; the risk of infection increases with the degree of immunosuppression; • a higher prevalence of persistent infection and infection with multiple high-risk HPV types; • a greater risk of precancer, which increases with the degree of immunosuppression and might be 2–6 times the risk in uninfected women; • an increased risk of developing cervical cancer; • diagnosis of invasive disease up to 10 years earlier than the average; • more frequent presentation with advanced disease with poor prognosis. It is still unclear if treatment of HIV-positive women with highly active antiretroviral therapy (HAART) substantially affects the natural history of SIL. Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer Chapter 2: Anatom y of the Fem ale Pelvis and Natural History of Cervical Cancer 2 42 ADDITIONAL RESOURCES • Berek JS et al., eds. Novak’s textbook of gynecology, 12th ed. Baltimore, MD, Lippincott, Williams & Wilkins, 1996. • IARC. Cervix cancer screening. Lyon, IARCPress, 2005 (IARC Handbooks of Cancer Prevention, Vol. 10). • Shaw RW, Soutter WP, Stanton SL, eds. Gynaecology, 3rd ed. Edinburgh, Churchill Livingstone, 2003. • Tavassoli FA, Devilee P, eds. Pathology and genetics of tumours of the breast and female genital organs. Lyon, IARCPress, 2003 (WHO Classification of Tumours). • WHO. Cervical cancer screening in developing countries. Report of a WHO Consultation. Geneva, 2002. 43 3 CHAPTER 3: HEALTH PROMOTION: PREVENTION, HEALTH EDUCATION AND COUNSELLING 44 45Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 CHAPTER 3: HEALTH PROMOTION: PREVENTION, HEALTH EDUCATION AND COUNSELLING Key points • Health promotion, including education and counselling of women and men, should be an integral part of all cervical cancer control programmes. • Health education should aim to ensure that women, their families and the community at large understand that cervical cancer is preventable. • Health education messages about cervical cancer should reflect national policy and should be culturally appropriate and consistent at all levels of the health care system. • Providers should be trained to discuss sexuality in a non-judgemental way and be able to address behavioural issues related to cervical cancer and HPV. • Privacy and confidentiality during counselling are essential elements of quality care. ABOUT THIS CHAPTER This chapter addresses the importance of integrating heath promotion into cervical cancer control activities, through health education, primary prevention and counselling. These three strategies transmit similar messages and require related and overlapping communication skills. The key messages related to behaviour change are outlined, as well as the evidence for the effectiveness of condoms and vaccines in reducing the harm done by HPV. The practice sheets (PS) at the end of the chapter list the key messages to be included in health education about cervical cancer, provide answers to frequently asked questions (FAQs) about cervical cancer and HPV, indicate how to involve men in preventing cervical cancer, and give more information on counselling. HEALTH PROMOTION Promoting health at the personal and societal levels, by helping people to understand and reduce their personal risk of illness, avoid harmful behaviours and adopt healthier lifestyles, is a key role of health programmes at all levels. In many countries, prevention has traditionally taken a secondary role to curative care, but is gradually becoming more evident; continuing efforts in this direction are needed. Health promotion can be implemented in multiple ways. Three strategies are particularly useful in relation to cervical cancer: primary prevention (of HPV infection), health education, and counselling. 46 Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 THE ROLE OF THE PROVIDER Providing correct information on cervical cancer in the community and in health services is key to raising awareness and reducing illness and deaths. All categories of health care providers, in whatever setting they work, should provide correct and consistent information to women and men on cervical cancer, how it can be prevented, reasons for screening, and the significance and management of any abnormalities detected. The language used should be tailored to the audience and in line with the provider’s function and training. Providers should always make sure that the information is fully understood by the woman and her support network. To be able to do this, providers must keep their own knowledge up to date and improve their communication skills. To change behaviour, knowledge is necessary but is not sufficient. Behaviour change will be more likely if providers assist women to assess their own risk of disease and empower them to reduce this risk. Communication skills are required for educating and counselling women, and for helping those in the target group to understand their need for screening, follow-up and treatment. If cancer is discovered, the women need to be told about the nature and prognosis of their disease. Once clear messages have been developed in simple language, health education in the clinic setting should not take much time, and can be done in group settings as well as in private consultations. PREVENTION OF HPV INFECTION HPV is a common virus, which is transmitted by close contact, including penetrative and non-penetrative sexual contact. A large proportion of men and women are infected with HPV at some time in their life. The only certain way to prevent genital HPV infection is to abstain completely from genital skin-to-skin contact and sexual intercourse. However, certain changes in sexual behaviour (e.g. using condoms, delaying first intercourse) offer some protection against HPV. Using condoms Condoms only offer partial protection against HPV transmission, because the virus can exist on body surfaces not covered by the condom, such as the perianal area and anus in men and women, the vulva and perineum in women, and the scrotum in men. Despite this, consistent and correct condom use has been shown to provide important benefits: • It allows faster HPV clearance in both men and women. • It increases regression of cervical lesions. • It reduces the risk of genital warts. • It reduces the risk of cervical precancer and cancer. 47Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 • It protects against other sexually transmitted infections (STIs), including chlamydia and HSV-2 infection, which are possible cofactors for cervical cancer. • It protects against HIV infection, a known facilitator of both high-risk HPV infection and progression to high-grade lesions. • It protects against unwanted pregnancy. Condoms may reduce the risk of developing HPV-related diseases because they decrease the amount of HPV transmitted or because they reduce the likelihood of re-exposure. Whether female condoms (which cover part of the vulva) offer the same or additional HPV protection as male condoms is as yet unknown. Condom promotion and distribution are essential Condom promotion and distribution are essential components of all STI control effortscomponents of all STI control efforts The future: vaccination against HPV infection Since most people are exposed to HPV once they become sexually active, an ideal way to prevent HPV infection would be through vaccination prior to exposure. The vaccine should protect against at least the most common high-risk types (HPV 16 and HPV 18), and preferably all the high-risk types. Recently developed candidate HPV vaccines designed to protect against infections with HPV 16 and HPV 18 have given promising results. However, many questions and programme concerns still need to be addressed before any vaccine can be effectively used. For example, it will be important to ensure equitable access to HPV vaccines, in order to attain high coverage of adolescents before they become sexually active. Any effect of a vaccine on the incidence of cervical cancer would not be detectable for some decades after its introduction. Widespread screening for cervical cancer would therefore need to continue, even after an HPV vaccine programme is fully implemented, in order to detect cervical abnormalities in the unvaccinated and previously infected population, and to monitor and evaluate progress towards the goals of the vaccination programme. Prevention of possible cofactors Men, women and adolescents need to be aware of the other factors associated with the development of cervical cancer in women infected with HPV (see Chapter 2). Even though understanding of cofactors remains incomplete, health care providers should develop strategies to reach individuals and communities, to disseminate information and provide advice on changing behaviour, e.g. reducing number of sexual partners, Condoms PS5 48 Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 stopping smoking, delaying first intercourse, and using condoms. Cervical cancer risk is also increased in women who use oral contraceptives for five years or more; however, the increase is very small and the benefits of preventing unwanted pregnancy and unsafe abortion greatly outweigh the risk. There is, therefore, no need to limit the use of hormonal contraceptives. HEALTH EDUCATION Health education involves communicating up-to-date general information and messages about changing behaviour in simple, understandable language, to individuals or groups. Messages should use locally and culturally appropriate terms, and should be developed in collaboration with the community and in accordance with national guidelines. It is important that the core of the messages is always the same, regardless of where, by whom and to whom they are given. Health education is not an isolated event; it should be a continuous activity and requires constant effort from managers and providers to maintain their knowledge up to date. Health education is needed to ensure optimal programme coverage, which in turn, will lead to increased programme impact. Many barriers to cancer screening programmes can be addressed through education of the community. For example, numerous studies have shown that many women do not attend screening programmes because they are not aware of their risk of cervical cancer or of the benefits of screening in its prevention and early detection. Women in developing countries and rural areas may not have heard of cervical cancer or screening tests, or may not be aware that a positive test result does not necessarily mean that they have cancer or that they are certain to die. Many misconceptions and beliefs about cancer reflect fears about the discovery of a disease they have heard is fatal. Often there is also stigma related to diseases of the reproductive tract, particularly sexually transmitted infections, including HPV. Fear and embarrassment about genital examinations, and concerns about lack of privacy and confidentiality, may keep women from attending services. Such fears and misconceptions can be dealt with by reassuring women about what is involved in an examination and screening. If such information is backed up by skilful, respectful provision of services, women will be more likely to attend and will be more likely to recommend screening to their friends and family. RECOMMENDATIONRECOMMENDATION Health education should be an integral part of comprehensive cervical cancer control. Health education PS1 FAQs PS2 49Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 Some misconceptions and facts about cervical cancer Misconception Fact Intrauterine devices (IUDs) cause cervical cancer. IUDs are not linked to any increase in cervical cancer. In screening, part of your body is removed. Cervical cancer screening involves a gentle collection of cells from the surface of the cervix; no pieces of tissue are removed. Screening is like a vaccine: once you have had it, you will not get cervical cancer. Screening in itself does not prevent cervical cancer, but it does detect if the cervix is normal or not. If abnormalities are detected early and are treated, cancer can be prevented. There is no point in going for cancer screening, because it only tells a woman that she has a fatal condition and nothing can be done for it. Screening can detect abnormalities before they become cancer. Also, if cancer itself is detected early, it can be cured with proper treatment. Cervical cancer is seen in women with poor hygiene practices. There is no evidence that poor hygiene causes cervical cancer. Use of tampons and herbs can cause cancer of the cervix. Cervical cancer is caused by a virus infection. Smoking and having multiple sexual partners can increase the risk, but use of tampons and herbs has not been shown to have any effect. In cervical cancer control programmes, health education includes: • informing people about cervical cancer, its causes and natural history; • promoting screening for women in the target group; • increasing awareness of signs and symptoms of cervical cancer, and encouraging women to seek care if they have them; • reducing ignorance, fear, embarrassment and stigma related to cervical cancer. Health education PS1 50 Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 How to provide health education • Messages should be developed to address common fears and misconceptions, as well as the stigma attached to STIs. • Providers should make efforts to overcome their own discomfort in talking about sexual matters and diseases that affect the genital organs. • Providers should give accurate information in an acceptable and non-judgemental manner. • Answers to frequently asked questions need to be developed locally, in consultation with the community and in harmony with local beliefs and practices. • The fact that cervical cancer is linked to HPV, a sexually transmitted infection, raises some difficult questions that providers need to be prepared to answer. Some examples and answers are provided in Practice Sheet 2. Where can health education take place? Information on cervical cancer can be provided within or outside the health facility, by a variety of health workers: doctors, nurses, health educators, nursing assistants, clinical officers, counsellors and community health workers. Other people, such as community leaders and traditional healers, can also provide health education if they are trained in the key messages formulated by the health authorities. Health education in health facilities Information can be provided to groups in waiting areas through posters, health talks, videos and written materials. Messages should be consistent, and should always be designed and pretested with the particular audience in mind. Information and education on cervical cancer for men and women can be integrated into health talks on antenatal and postnatal care, family planning, acquired immunodeficiency syndrome (AIDS), chronic care and STIs. In groups consisting mostly of young women at low risk, messages can be framed simply to inform the group and promote screening for women in the target age. To deliver messages effectively, skills in adult education are needed. Messages should also be given to individual women during their visits to health facilities, tailored to their age and other risk factors. For example, a woman over 30 years of age, who presents with STI symptoms and who has never been screened should, in addition to receiving education and services specific to her symptoms, be given information on cervical cancer. If she cannot be screened immediately, she should FAQs PS2 51Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 be strongly encouraged to return soon for screening. On the other hand, a teenager who comes only for family planning can be given general information, assured that she will not need to be screened until she is 25–30 years old, and encouraged to tell older women in her family about the need for screening. Screening can be offered to all women at risk who attend health facilities for any service for themselves or their children. In addition, everyone who works in a health facility, including cleaners, secretaries, and drivers, can be enlisted in this effort and trained to deliver appropriate messages. For example, cleaners and drivers should know the hours and location of screening services; receptionists can be trained to answer questions on the recommended age for screening and on the nature of the procedure, and to help clients obtain more information. Outreach in the community Community education may take place in a variety of settings, such as with religious or community groups, in schools, at sports activities, on health awareness days, or in the context of a screening campaign. Various members of the community can be trained to deliver key messages: medical professionals, teachers, community leaders, health promoters, traditional healers and midwives. Written materials, radio and television messages, newspaper articles, posters and pamphlets are all ways to reach people in the community. The approach to educating the community about cervical cancer and the benefits of screening can be adapted to the audience and the setting, but the content of the messages must not vary. 52 Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 STORY STORY 33 DawnDawn,, a 32-year-old Kenyan woman, was not sick. In fact she was in high spirits. Shortly before, a community health worker’s announcement at a funeral had inspired her. He had spoken about a chronic disease that affects women – cancer of the cervix – and explained that the disease is preventable. If cervical cancer is not detected early and treated, a woman can die from the disease. The community workerThe community worker gave Dawn a card and told her where she should go to have a screening test. “For some reason, I felt it was important for me to attend and find out if I had any risk because, after all, I could get help.” When she returned two weeks later, she was told her test was negative meaning it was normal. “I was greatly relieved.” Now, she was informed, she only needs to return for another test in three years’ time. Because she was treated so kindly and learned so much, Dawn has begun to speak publicly about her experience whenever an opportunity arises. Many women she has spoken to have followed her advice and have been tested, even if they had no symptoms. Two of these women have reported to Dawn that they were being treated for precancer so they would not get cancer. Dawn is happy to be helping others. “I don’t want anyone to die when there is opportunity for us to live longer,” she says. Reaching men As with other aspects of reproductive health, it is crucial to reach men in clinical and community settings with messages about cervical cancer prevention, sexual transmission of HPV, and the importance of encouraging their partners to be screened and treated when necessary. Unsafe sexual behaviour in men is a risk factor for their partners. Thus, information about prevention of HPV and its role in cervical cancer should be included in STI and HIV prevention messages in all settings where men seek care. Condoms should be widely available. 3 Adapted from: Alliance for Cervical Cancer Prevention. Women’s stories, women’s lives: experiences with cervical cancer screening and treatment. Seattle, WA, 2004. To Men PS3 53Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 COUNSELLING Counselling is face-to-face, personal, confidential communication, in which the counsellor helps the client to make decisions and act on them. Counselling requires listening and conversational skills and knowledge of the subject being discussed. All providers should be trained in counselling skills, to help them communicate effectively with clients. Counselling can help a person to make decisions only if: • there is mutual trust between the client and the counsellor; • there is a two-way transfer of relevant, accurate and complete information. The content of counselling about cervical cancer will vary according to the client’s problem or concern and her individual circumstances. It can cover prevention, screening, follow-up, referral, diagnosis, treatment of precancerous conditions, and treatment of invasive cancer. Counselling can also help patients and their families to cope with a diagnosis of invasive cancer and terminal disease. Such counselling may involve only the patient, or also her partner and other family members, especially if decisions concerning severe disease or costly treatment need to be made. A good counsellor uses verbal and non-verbal communication skills, and helps the client feel at ease by empathizing with her situation, reassuring her, and fostering a sense of partnership in helping her solve her problem. Providers at all levels involved in cervical cancer control who have face-to-face contact with patients may provide counselling. The depth and detail of communication will vary according to the patient’s situation and needs and the category and level of provider. Counselling should be structured to educate the woman, review the results of screening and follow-up, present alternative services and procedures, and discuss any follow-up she may need. This will give the woman the tools she needs to make rational decisions for herself. Who needs to be counselled? All women who have to decide whether to have a service should receive counselling, as well as those who have chosen to have the service and need information on what it entails and how it relates to their present and future health. Some guidelines on good counselling are found in Practice Sheet 4. Counselling PS4 54 Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 Privacy and confidentiality Ensure privacy by conducting counselling in a setting where the woman and the provider will not be seen or heard, except by people specifically agreed to by the woman. Confidentiality is also essential, which means that nothing that is discussed during a consultation or found during an examination may be disclosed to anyone, without prior authorization. Privacy and confidentiality are essential in counselling, as in all aspects of patient care, and are especially important in relation to conditions that involve the genital area and that may require an examination that is embarrassing to the patient. If a patient feels that there is lack of privacy in a clinic or that the provider is judgemental or disapproving, or might reveal information to others, she may choose to withhold important information, attend a distant clinic or not seek care at all. • Ensure that no one can see or overhear consultations, counselling and examinations. • Ensure confidentiality: special efforts are needed in many health care settings, particularly those that are busy or crowded. • Store forms and records securely; only relevant staff should have access to them. • Avoid talking about patients with other clinic staff, both inside and outside the clinic. • Treat patients with respect, regardless of their age, illness, lifestyle and marital or socioeconomic status. • Health care providers who know the extended families or neighbours of patients must take extra care to reassure patients that confidentiality will be respected. 55Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3• Assess gaps in knowledge, myths and negative attitudes prevalent in the community. • Develop key messages about prevention and use them in health education and counselling. • Give health talks tailored to specific audiences (young people, men, women of different ages) in different venues. • Distribute information, education and communication (IEC) materials. • Counsel individual women in the community about cervical cancer and its prevention, screening, and treatment (depending on individual needs). • Use every opportunity to provide information and education, and to promote behaviour change to groups of patients. • Counsel individual women and men, as well as couples, on cervical cancer prevention and early detection. • Promote screening for women in the target age group, in waiting rooms and outpatient clinics and by outreach to the community. • Train and assist community health workers and community volunteers to educate the community. Ensure that they use agreed key messages. • Educate and counsel women in waiting rooms, outpatient clinics and wards on cervical cancer, its prevention and early detection. • Promote screening at all opportunities, including in outreach activities to the community. • Train and supervise workers, and support education in communities and health centres, ensuring that messages on cervical cancer prevention are consistent. Carry out all activities performed at district hospitals, plus: • Develop clear information and education materials for patients and families on cervical cancer diagnosis, treatment and palliative care. • Inform and educate policy-makers and decision-makers on cervical cancer, its effects on health in the population, and the costs to the system, as well as the cost–benefit of organized efforts to prevent and detect it. HEALTH EDUCATION AND COUNSELLING AT DIFFERENT LEVELS In the community At the health centre At the district hospital At the central hospital 56 Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 Counselling messagesCounselling messages The community health workers and other health care providers can talk to individual women who consult them about: • the target group for cervical cancer screening; • the screening test that is used, how it is done and what it can tell about the cervix; • what is involved in a pelvic examination and screening test, and where and when screening is available. They can also: • help overcome women’s reluctance to have a pelvic examination; • stress the need to follow advice regarding return to the health centre for results or follow-up; • explain that she will be given a thorough explanation of the clinic procedures and she can accept or decline to have any of them (informed consent); • tell her that she may bring someone with her if she wishes. ADDITIONAL RESOURCES • ACCP. Planning and implementing cervical cancer prevention and control programs: a manual for managers. Seattle, WA, Alliance for Cervical Cancer Prevention, 2004. • Bradley J et al. Whole-site training: a new approach to the organization of training. New York, Association for Voluntary Surgical Contraception, 1998 (AVSC Working Paper, No. 11; www.engenderhealth.org). • Burns A et al. Where women have no doctor: a health guide for women. Berkeley, CA, Hesperian Foundation, 1997. • Cervical cancer prevention guidelines for low-resource settings. Baltimore, MD, JHPIEGO Corporation, 2001. • GATHER guide to counselling. Baltimore, MD, Johns Hopkins School of Public Health, Population Information Program, 1998 (Population Reports, Series J, No. 48; www. jhuccp.org). • Hubley J. Communicating health: an action guide to health education and health promotion. London, Macmillan, 1993. 57Chapter 3: Health Promotion: Prevention, Health Education and Counselling Chapter 3: Health Prom otion: Prevention, Health Education and Counselling 3 • Prevention and management of reproductive tract infections (RTIs): the comprehensive reproductive health and family planning training curriculum. Watertown, MA, Pathfinder International, 2000. • WHO. Sexually transmitted and other reproductive tract infections. A guide to essential practice. Geneva, 2005. • Working with men. New York, EngenderHealth, 2005 (http://www.engenderhealth. org/ia/wwm/index.html) [resources for male involvement in reproductive health programmes]. 58 59PS 1: Health Education Practice Sheet 1: Health Education PS 1 PRACTICE SHEET 1: HEALTH EDUCATIONPRACTICE SHEET 1: HEALTH EDUCATION This Practice Sheet provides key evidence-based messages that can lead to behaviour changes that will reduce the harm done by cervical cancer. To be an effective health educator about cervical cancer:To be an effective health educator about cervical cancer: • You should have correct up-to-date knowledge about cervical cancer and good • You should have correct up-to-date knowledge about cervical cancer and good communication skills.communication skills. • You should transmit consistent messages about cervical cancer, tailored to the • You should transmit consistent messages about cervical cancer, tailored to the educational background and culture of the audience.educational background and culture of the audience. • You should be comfortable talking about sexuality and behaviour that increases • You should be comfortable talking about sexuality and behaviour that increases risk of HPV infection and cervical cancer.risk of HPV infection and cervical cancer. • You should feel comfortable explaining how to use male and female condoms.• You should feel comfortable explaining how to use male and female condoms. • Your messages must be in line with national policy and appropriate to the local • Your messages must be in line with national policy and appropriate to the local situation.situation. Key cervical cancer messages for men and women • Cervical cancer is the leading cause of cancer deaths in women in their 40s, 50s and 60s in developing countries. • Cervical cancer is caused by an infection with human papillomavirus, a very common viral, sexually transmitted infection. This infection very often occurs in young men and women who may not be aware of it. • Condom use offers partial protection from HPV and may lower the risk of developing HPV-related diseases, such as genital warts and cervical cancer. • Most HPV infections do not persist and do not cause cancer. • The few HPV infections that do persist may lead to precancer; if not treated, this may become cancer. • It usually takes many years for HPV infection to cause precancer and years longer for precancer to progress to cancer. • Screening can detect precancer. Most abnormal conditions found on screening are curable. • Women aged 25 years and older are more likely than younger women to have cervical precancer. Women should be screened at least once between the ages of 35 and 45 years and, if possible, every 3 years from age 25 to 65 years (or according to national guidelines). • Screening is relatively simple, quick and painless. • Precancerous lesions can be treated simply, and a hospital stay is not usually required. 60 PS 1: Health Education Practice Sheet 1: Health Education PS 1 • If cancer is found and treated early, it can be cured. • Women need to seek medical care promptly if they have abnormal discharge, vaginal bleeding, bleeding after sexual intercourse, or any bleeding after menopause; these may be signs of cervical cancer. • Women have a right to make their own decisions about their health (involving their partner or family if they so wish). While screening and follow-up are highly recommended, women should be free to refuse any test or treatment. Messages about personal behaviour • Delay first sexual intercourse: people who engage in early sexual activity are more likely to be infected with HPV. Younger women are more vulnerable to being infected with a single sexual act. • Delay first childbearing: the hormones of pregnancy may increase the risk of developing cervical cancer. • Limit the number of pregnancies: women who have had 5 or more children have a higher chance of developing cervical cancer. • Reduce the number of sexual partners: the more partners a person has, the greater the chance of becoming infected with an STI, including HPV and HIV, both of which increase the risk of cervical cancer. • Avoid partners who have multiple partners: women whose partners have or have had multiple partners have a higher rate of cervical cancer. • Use condoms: condoms have been shown to protect against STI and to reduce the risk of cervical cancer. • Do not smoke tobacco: women who smoke have a higher risk of almost all cancers, including cervical cancer. • Seek treatment immediately if you have symptoms of an STI, or suspect that you have been exposed to an STI. Some STIs may facilitate the development of cervical cancer and cause other undesirable health effects, including infertility. Prompt treatment of STIs may protect against HPV and cervical cancer. • If you are over 25, go for screening. Almost all women who have had sexual intercourse have probably been exposed to HPV. Screening can detect early lesions so they can be treated before they have a chance to progress to cancer. • Special message to men and boys: reduce the number of your sexual partners, and always use condoms, especially with new partners. 61PS 1: Health Education Practice Sheet 1: Health Education PS 1Note to the educatorNote to the educator Some of the above behaviours may be difficult to put into practice, especially Some of the above behaviours may be difficult to put into practice, especially for women who cannot control when, with whom, and how they have sexual for women who cannot control when, with whom, and how they have sexual intercourse. Making men aware of these facts may lead them intercourse. Making men aware of these facts may lead them to treat their partners more equitably. to treat their partners more equitably. Supplies for health education Health education is best provided in face-to-face encounters. Using the following materials, if they are appropriate to your community, can assist: • flipcharts; • brochures; • slide shows; • drama and role-plays; • videos; • radio and television programmes; • presentations by experts who can communicate in nontechnical language. 62 PS 1: Health Education Practice Sheet 1: Health Education Practice Sheet 1: Health Education PS 1: Health Education PS 1 63 Practice Sheet 2: Frequently Asked Questions (FAQs) About Cervical Cancer PS 2 PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer PRACTICE SHEET 2: FREQUENTLY ASKED QUESTIONS PRACTICE SHEET 2: FREQUENTLY ASKED QUESTIONS (FAQs) ABOUT CERVICAL CANCER(FAQs) ABOUT CERVICAL CANCER Men, women and even health care providers often lack information on cervical can- cer. This Practice Sheet lists some frequently asked questions and provides answers to them. You and your colleagues should add other questions relevant to the local situation, and their answers. CAUSES AND RISK FACTORS Q What is cancer? A Cancer is the uncontrolled growth of certain cells in the body, causing tumours or growths. Not all growths are cancer. Those that spread to other parts of the body and can interfere with normal functions are called cancer. Q What is cervical cancer? A It is cancer that begins on the cervix, which is the opening of the womb. Cells on the cervix begin to grow abnormally and sometimes, if they are not treated, they become cancer. However, these early (precancerous) changes can disappear on their own, without causing problems. Q What causes cervical cancer? A Cervical cancer is caused by infection with a virus called human papillomavirus or HPV. Most of the time, HPV infection disappears without treatment; sometimes, however, HPV stays in the cells for years and, in some women, eventually causes cervical cancer. Not much is known about why some women get cervical cancer and others do not. Q Is cervical cancer a sexually transmitted infection (STI)? A No, but HPV is a sexually transmitted infection, which is quite common in both men and women. Only a few women with HPV will go on to get precancer. If not treated, some of these women will develop cervical cancer, many years after they were infected with HPV. 64 PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer Practice Sheet 2: Frequently Asked Questions (FAQs) About Cervical Cancer PS 2 Q Can cervical cancer be prevented? A Yes. Limiting the number of new sexual partners, using condoms, delaying first sexual relations and childbearing, and not smoking tobacco help prevent cervical cancer. HPV vaccines are now being tested and will probably be the most effective means of prevention, when they become widely available. Once they are available, they will need to be given to young people before they start to have sexual relations. The best way to prevent cervical cancer today is through screening of women for precancer, which can be treated before it becomes cancer. Q Who is at risk of cervical cancer? A All women who have had sexual intercourse are potentially at risk because they might have been infected with HPV. Cervical cancer is most commonly found in women in their 40s and 50s. The women most at risk are those who have never been screened, had sexual intercourse and children at a young age, have had more than 5 children, have multiple partners or partners who have multiple partners, and smoke tobacco. Being infected with HIV also puts women at higher risk. Q Are women who take hormonal contraceptives at increased risk for cervical cancer? A There is a slightly increased risk when oral contraceptives are used for a long time. Women who take OC, as others, should be screened regularly. There is no reason to stop using contraceptives as the benefits outweigh the risks. Q Do genital warts cause cervical cancer? A No. Cancer is caused by certain high-risk types of HPV. Genital warts are caused by different low-risk HPV types, which do not cause cancer. SCREENING Q What is a screening test? A A screening test is a test done on people who are healthy and without symptoms, to identify those with a higher chance of getting a particular disease. A cervical cancer screening test can determine if a cervix is normal or not. It can detect early signs of disease before a woman has symptoms, when treatment can prevent the disease from developing. 65 Practice Sheet 2: Frequently Asked Questions (FAQs) About Cervical Cancer PS 2 PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer Q Who should be screened for cervical cancer? A Women between the ages of 25 and 65 years (or according to national norms) should have a screening test to detect early changes. Women younger than 25 almost never get cervical cancer and do not need to be screened. Women who have never had sexual intercourse do not need to be screened. Q What exactly is done during screening? A The most common screening test is the Papanicolaou (Pap) smear. The health care provider will do a genital examination to look at the cervix, collect a sample of cells from your cervix, and send it to the laboratory to be examined. Other tests are sometimes used to screen for cervical cancer, such as looking at the cervix after putting vinegar on it. The provider will tell you about the test used in your area. Q What if my test is negative? A If your screening test is negative, it means that you do not have any changes that might develop into cervical cancer. It is important to be screened at regular intervals (every 3–5 years, depending on local norms) to make sure that such changes do not develop. Q What if my test is positive? A In most cases a positive test means you have precancer, a condition that might go away on its own or that can be easily treated in an outpatient setting. You might need to have other tests to make sure that what you have is precancer, and not cancer. Sometimes a positive test means you have cancer. In this case, you will be referred to a hospital for treatment. PRECANCER AND CANCER Q What is precancer? A Precancer results when the cervix has been infected with high-risk HPV for some time. It is easily treated. Most precancer goes away on its own, but if it persists and is not treated, it can become cancer. Q What are the signs of cervical cancer? A Early cervical cancer usually has no signs, which is why screening is so important. Signs of cancer are: vaginal spotting or bleeding after sexual intercourse, between menstruations, or after menopause, and foul-smelling discharge that does not go away even with treatment. If you have any of these signs, you should see a health care provider, because the earlier cancer is found, the better your chance of being cured. 66 PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer Practice Sheet 2: Frequently Asked Questions (FAQs) About Cervical Cancer PS 2 Q Can cervical cancer be treated? A Most cervical cancer can be successfully treated if it is found early. In middle- aged women who have never been screened, cancer may be discovered late, when it has already spread beyond the cervix and is more difficult to treat. Q Can cervical cancer be cured? A Yes, cervical cancer is curable, if it is found before it has spread too far. The earlier cancer is found, the better your chance of being cured. Q How is cervical cancer cured? A There are two major ways to treat and cure cervical cancer—by an operation to remove it surgically, or by radiation therapy which kills the cancer cells. Sometimes both methods are used. 67PS 3: How to Involve Men in Preventing Cervical Cancer Practice Sheet 3: How to Involve M en in Preventing Cervical Cancer PS 3 PRACTICE SHEET 3: HOW TO INVOLVE MEN PRACTICE SHEET 3: HOW TO INVOLVE MEN IN PREVENTING CERVICAL CANCER IN PREVENTING CERVICAL CANCER Cervical cancer is exclusively a woman’s disease, but men can play a key role in preventing and treating it. Infection with HPV is sexually transmitted, and men therefore can contribute to preventing it. This Practice Sheet provides basic information that men need, and suggests ways to involve them in cervical cancer control. BASIC INFORMATION FOR MEN ON CERVICAL CANCER • General messages can be found in Practice Sheet 1 on health education. • Cervical cancer is common and is usually seen in women aged 40 years or over. Cervical cancer develops from precancer, which can be detected by screening and treated. Women over 25 years should be screened. • Most cervical cancer is caused by infection with a virus, the human papillomavirus (HPV). This virus is easily passed between people who have sexual contact. It causes no symptoms. • HPV can also threaten men’s health; if it persists, it can increase the risk of cancer of the penis. • HPV is sexually transmitted, but penetration is not essential as the virus can live on the skin, outside the genital area. • Using condoms does not offer complete protection, but it can cause infections to disappear faster, and thus has a role in the prevention of cervical cancer. • Smoking tobacco can increase the risk of many cancers in men and women, including cervical cancer in women infected with HPV. • Men can play a key role in the prevention of cervical cancer in women, by: – reducing the number of their sexual partners and using condoms if they have more than one relationship; – using condoms to prevent STIs, including HIV/AIDS; – encouraging their partners to be screened if they are over 25 years of age; – collaborating with partners to avoid unwanted pregnancies and pregnancy at very young age; – not smoking and helping their partners not to smoke. • Men whose partner is found to have precancer or cancer can support and assist her in obtaining the recommended treatment, by accompanying her to clinical appointments, and by learning about cervical cancer. Health education PS1 68 PS 3: How to Involve Men in Preventing Cervical Cancer Practice Sheet 3: How to Involve M en in Preventing Cervical Cancer PS 3 • Men need to cooperate with their partners, if they are told in the clinic to abstain from sexual intercourse, as may be the case following certain tests and treatments. • Men can reduce the work burden of their partner when she has had surgery, chemotherapy, or radiation for cervical cancer. These treatments can help cure the cancer, but they can make the woman feel tired and weak. She will need time for rest and recuperation. • Where a woman has very advanced cervical cancer, her partner can assist by providing maximum comfort. • Men can also contribute to reducing cervical cancer deaths in their community and country, by advocating for women’s health programmes. To men:To men: You have a very important role in the prevention and treatment of cervical cancer.You have a very important role in the prevention and treatment of cervical cancer. Please use condoms consistently and correctly; this will lead to improved sexual Please use condoms consistently and correctly; this will lead to improved sexual and reproductive health for yourself and your partner.and reproductive health for yourself and your partner. 69PS 4: Counselling Practice Sheet 4: Counselling PS 4 PRACTICE SHEET 4: COUNSELLING PRACTICE SHEET 4: COUNSELLING What is counselling? Counselling is face-to-face, personal and confidential communication, aimed at helping a person (and her family) to make informed decisions and then to act on them. It is a two-way exchange of relevant and accurate information. To be an effective counsellor, you should have the ability to listen, up-to-date knowledge, and conversational skills. What background knowledge on cervical cancer does the patient need to have? The counsellor should ensure that all women, especially those targeted for cervical cancer control programmes, have the following basic knowledge: • the basic anatomy of the cervix, its location in the pelvis, the changes it undergoes at different ages, and how it can be examined; • what cervical cancer is, what causes it, and the risk factors for developing it; • how to prevent cervical cancer, with emphasis on screening and treatment of precancerous lesions; • what screening test and which treatments for abnormalities detected on screening are used locally; • options available for women who have invasive cancer detected by screening and diagnosis. Drawings and illustrations, as well as the information provided in this Guide and in Practice Sheets 1 and 2, are useful aids in explaining the above. What must the counsellor ensure? • Privacy: no one, unless specifically permitted by the woman, should be able to see or hear anything that goes on between the woman and the counsellor. • Confidentiality: nothing seen, heard or done during counselling and examination should be known by anybody else, unless the woman specifically authorizes it. • Mutual trust between provider and patient. • Sensitivity in addressing and discussing private topics, particularly related to sexuality and behaviour. Health education PS1 FAQs PS2 70 PS 4: Counselling Practice Sheet 4: Counselling PS 4 Suggestions for counselling on cervical cancer 1. Welcome the woman warmly by name and introduce yourself. 2. Sit close enough that you can talk comfortably and privately. 3. Make eye contact; look at her as she speaks. 4. Assure her that nothing that is discussed will be repeated to anybody. 5. Use language that she can understand and provide relevant information. 6. Tailor the information you give and the discussion to the reason she is here today. 7. Listen attentively and take note of her body language (posture, facial expression, eye contact). 8. Try to understand her feelings and point of view. 9. Use open-ended questions to invite more than “yes” or “no” answers. 10. Be encouraging. Nod or say: “Tell me more about that.” 11. Try to identify her real concerns. 12. Explain all the options available and respect her choices. 13. Always verify that she has understood what was discussed by having her repeat the most important messages or instructions. 14. Invite her to return if and when she wishes. Counselling “do’s” • Ensure privacy. • Greet the woman by name and introduce yourself. • Look the woman in the face unless culturally not appropriate. • Use a natural, understanding manner. • Be empathetic: place yourself in the woman’s situation. • Use approving body language (nod, smile, etc., as appropriate). • Use simple language and terms the woman understands. • Answer her questions truthfully. • Allow enough time for the session. • If she has doubts, invite her to return later to inform you of what she (and possibly her family) has decided. 71PS 4: Counselling Practice Sheet 4: Counselling PS 4 Counselling “don’ts” • Appear to be distracted (looking at your watch, answering the phone). • Use a harsh tone of voice, or act impatient. • Allow interruptions during the visit. • Interrupt the woman. • Be critical, judgemental or rude. • Overwhelm the woman with too much detail or irrelevant information. • Use medical words the woman does not understand. • Force a decision; if she has doubts, invite her to return later to inform you of what she (and possibly her family) has decided. STANDARD COUNSELLING STEPS FOR ANY WOMAN HAVING A TEST, PROCEDURE OR TREATMENT While you are doing the procedure After the procedure Before the procedure • Explain again why it is important for her to be screened or to undergo the procedure or the treatment recommended. • Explain what will be done: how it is done, what it can show, possible need for future tests or treatments. • Invite and respond to questions and obtain informed consent, including consent to be contacted at home or work if necessary. • Tell the woman what you are doing at each step. If what you are about to do may cause pain, cramps or other discomfort, warn her in advance. This will help her feel comfortable. • Explain what you did. • Describe any noted abnormalities or reassure the woman that you did not see anything unusual. • Agree a date for the return visit. • Explain the importance of her returning to the clinic as planned. Informed consent PS6 72 PS 4: Counselling Practice Sheet 4: Counselling PS 4 If you noted something for which you wish to refer her to a higher level for further examination or tests: • Explain why, where and when she must go, and whom to see. • Stress the importance of keeping this appointment. • Answer any questions she has or, if you do not know the answer, find someone who does. • Invite her to return if she has any questions or concerns about this appointment, and respond or find answers from someone who knows. PS 5: How to Use Male and Female Condoms PS 5 73 PRACTICE SHEET 5: HOW TO USE MALE PRACTICE SHEET 5: HOW TO USE MALE AND FEMALE CONDOMSAND FEMALE CONDOMS 44 Messages about condoms to be communicated to men and women • Condoms are the most reliable available method of protection against STIs. • Used correctly, a condom forms a barrier that keeps out even the smallest bacteria and viruses. • Because HPV can infect tissue outside of the area normally covered by a condom, condoms cannot completely prevent HPV infection. • However, the use of condoms has been shown to: – speed up HPV clearance; – reduce the risk of genital warts; – reduce the risk of cervical cancer; – protect against Chlamydia and HSV infection (possible cofactors for cervical cancer); – protect against other STIs; – protect against HIV infection; – protect against pregnancy. When should you recommend that a woman use condoms? • If she is diagnosed with an HPV infection or a low-grade lesion (LSIL) which is being watched. • When there is a risk of infection or bleeding and she is not able to follow advice to abstain from intercourse. This is the case after certain procedures, such as cryotherapy (see Chapter 5). • For simultaneous prevention of most sexually transmitted infections, including HIV, and pregnancy (dual protection). • While she is being treated for any STI. • When her partner has symptoms or is being treated for an STI. Condoms only protect when they are used consistently and correctly!Condoms only protect when they are used consistently and correctly! 4 Adapted from: Sexually transmitted and other reproductive tract infections. A guide for essential practice. Geneva, WHO, 2005. Practice Sheet 5: How to Use M ale and Fem ale Condom s 74 PS 5: How to Use Male and Female Condoms PS 5 Practice Sheet 5: How to Use M ale and Fem ale Condom s MALE CONDOMS Male condoms are made of latex; they are widely available and inexpensive, highly effective in preventing STIs and partially effective in preventing HPV transmission. Instructions for use 1. Remove the condom from the package carefully, to avoid tearing. 2. Squeeze the air out of the tip of the condom. 3. Unroll the condom onto the erect penis. 4. After ejaculation, withdraw the penis from the vagina while the penis is still erect. Hold on to the rim of the condom while withdrawing to prevent it from slipping off and the semen spilling into the vagina. 5. Remove the condom from the penis, and tie a knot in it to prevent spills or leaks. Dispose of the condom safely (where it cannot cause any hazard). PS 5: How to Use Male and Female Condoms Practice Sheet 5: How to Use M ale and Fem ale Condom s PS 5 75 FEMALE CONDOMS The female condom is a soft, loose-fitting sheath with a flexible polyurethane ring at each end. The inner ring at the closed end is inserted into the vagina. The outer ring at the open end remains outside the vagina during intercourse and covers outer genitalia. Female condoms are made of polyurethane and come in only one size. They probably offer the same level of protection as male condoms, but are considerably more expensive. One advantage is that the woman has greater control in using them than in using male condoms. Instructions for use 1. Remove the female condom from the package, and rub it between two fingers to be sure the lubricant is evenly spread inside the sheath. If you need more lubrication, squeeze two drops of the extra lubricant included in the package into the condom sheath. 3. Using your index finger, push the sheath all the way into your vagina as far as it will go. It is in the right place when you cannot feel it. Do not worry, it cannot go too far. 2. The closed end of the female condom will go inside your vagina. Squeeze the inner ring (closed end) between your thumb and middle finger. Insert the ring into your vagina. 76 PS 5: How to Use Male and Female Condoms PS 5 Practice Sheet 5: How to Use M ale and Fem ale Condom s 5. After intercourse you can safely remove the female condom at any time. If you are lying down, remove the condom before you stand to avoid spillage. Dispose of the female condom safely (where it cannot cause any hazard). Do not reuse it. 4. The ring at the open end of the female condom should stay outside your vagina and rest against your labia (the outer lip of the vagina). Be sure the condom is not twisted. Once you begin to engage in intercourse, you may have to guide the penis into the female condom. If you do not, be aware that the penis could enter the vagina outside of the condom’s sheath. If this happens, you will not be protected. PS 5: How to Use Male and Female Condoms Practice Sheet 5: How to Use M ale and Fem ale Condom s PS 5 77 INSTRUCTIONS FOR COUNSELLING ON CONDOM USE • Male and female condoms are only effective if they are used correctly every time when having intercourse. • Providers need to overcome their own reluctance to talk about and touch condoms. They should show patients and their partners how a condom is used. • When instructing and counselling patients and their partners in how to use condoms, use a model penis or vagina. These can be bought, or you could make one with locally available materials. • Demonstrate how to open a condom package, how to unroll the condom, how to place it on the erect penis (for a male condom) or inside the vagina (for a female condom), how to remove the penis from the vagina when still erect, how to remove the condom, and how to dispose of it safely. • During or after your demonstration, ask the patient and her partner to do the same actions using a new condom on the same or another model. Gently correct any errors. • Advise patients and partners to be particularly careful about the following: – When opening a condom package, avoid tearing the condom; do not use teeth or long nails. – Use condoms only once. – Have a supply always available. • Provide sufficient condoms to every patient, including those who have been advised to abstain from sexual intercourse. Make sure women and men know how to use them, and where to obtain them in the community. 78 PS 5: How to Use Male and Female Condoms PS 5 Practice Sheet 5: How to Use M ale and Fem ale Condom s 79 4 CHAPTER 4: SCREENING FOR CERVICAL CANCER 80 Chapter 4: Screening for Cervical Cancer 81 4 Chapter 4: Screening for Cervical Cancer CHAPTER 4: SCREENING FOR CERVICAL CANCER Key points • Screening is testing of all women at risk of cervical cancer, most of whom will be without symptoms. • Screening aims to detect precancerous changes, which, if not treated, may lead to cancer. • Screening is only effective if there is a well organized system for follow-up and treatment. • Women who are found to have abnormalities on screening need follow-up, diagnosis and possibly treatment, in order to prevent the development of cancer or to treat cancer at an early stage. • Several tests can be used in screening for cervical cancer. The Pap smear (cytology) is the only test that has been used in large populations and that has been shown to reduce cervical cancer incidence and mortality. Other tests (VIA, VILI, HPV) show promise but there is as yet no comparable evidence on their effectiveness. Large studies are still under way. • Regardless of the test used, the key to an effective programme is to reach the largest proportion of women at risk with quality screening and treatment. • Organized screening programmes designed and managed at the central level to reach most women at risk are preferable to opportunistic screening. ABOUT THIS CHAPTER This chapter provides detailed information on screening, and explains why organized screening is superior to opportunistic screening. It describes available screening tests and their comparative advantages and disadvantages. ROLE OF THE HEALTH CARE PROVIDER The health care provider is a central figure in any coordinated public health effort to screen women for cervical cancer. Such an effort may include the ministry of health, programme planners, managers, laboratory technicians, health professionals and community workers. The role of health care providers is to ensure that: • Women who come for screening receive appropriate information and counselling. • National guidelines on cervical cancer screening and treatment are followed. • Screening is well organized and no opportunity to screen targeted women attending services is missed. 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer82 • Each woman who comes for screening understands what is involved and gives informed consent for screening and follow-up. • The screening test, treatment and referral are performed competently; patients are properly assessed and infection control measures are strictly adhered to. • Women screened are informed of their test results, especially if they are inadequate or positive (abnormal). • Any sexual and reproductive health problems identified by either the patient or the provider are managed appropriately. • Appropriate and confidential records are kept in the facility; the records may be given to the woman herself. • Women who need repeat screening, further testing, referral, or care after treatment are followed up appropriately. These responsibilities are further explained in this chapter. STORY STORY 55 Pratibha is a 37-year-old womanPratibha is a 37-year-old woman living in Maharashtra, India. One day, when she returned home from fetching water, she found two women health workers talking with her husband. The health workers asked her many questions, such as how old she was, when she married, and how many children she had. Then they told her about cervical cancer and about an opportunity for her to be screened in the village. Pratibha asked why she was selected for this and she was relieved to learn that all women over 30 years old in the village were being visited and invited to attend the screening clinic. One of the advantages of attending this programme was that testing and treatment (if needed) were free. Almost all the women invited attended the clinic, including Pratibha. The test was fast and painless, as she had been told it would be. After the examination, the health worker empha- sized that she should return in two weeks to get the test results. When Pratibha returned, she was told that her test was normal and that it would be important for her to repeat the test every 3 years. 5 Adapted from: Alliance for Cervical Cancer Prevention. Women’s stories, women’s lives: experiences with cervical cancer screening and treatment. Seattle, WA, ACCP, 2004. Chapter 4: Screening for Cervical Cancer 83 4 Chapter 4: Screening for Cervical Cancer SCREENING PROGRAMMES What is screening? Screening is a public health intervention used on a population at risk, or target population. Screening is not undertaken to diagnose a disease, but to identify individuals with a high probability of having or of developing a disease. Women targeted for screening for cervical cancer may actually feel perfectly healthy and may see no reason to visit a health facility. Not all diseases can be screened for. The following criteria should be met by any disease that is the object of a screening programme: • The disease must have serious public health consequences. • The disease must have a detectable preclinical stage (without symptoms). • The screening test must be simple, non-invasive, sensitive, specific, inexpensive and acceptable to the target audience. • Treatment at the preclinical stage must favourably influence the long-term course and prognosis of the disease. • Any further testing and treatment needed must be available, accessible and affordable for those who have a positive screening test. Cervical cancer meets these criteria. Screening programmes will only be successful if the following elements are present: • high coverage 6 (80%) of the population at risk of the disease; • appropriate follow-up and management for those who are positive on screening. Efforts to increase coverage will be wasted if those who test positive are not followed up correctly; • effective links between programme components (e.g. from screening to diagnosis and treatment); • high quality of coverage, screening tests, diagnosis, treatment, and follow-up; • adequate resources. Cervical cancer screening aims to test the largest possible proportion of women at risk and to ensure appropriate follow-up for those who have a positive or abnormal test result. Such women will need diagnostic testing and follow-up or treatment. Colposcopy and biopsy are often used to reach a specific diagnosis of the extent of the abnormality in women with a positive screening test (see Chapter 5). 6 “Coverage” is the proportion of women in the target age group who are screened at the recommended intervals during a given time period. The number of screening tests done is not coverage, since this number may include women outside the target age, and women screened more often than recommended. 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer84 Organized and opportunistic cervical cancer screening Organized screening Organized screening is designed to reach the highest possible number of women at greatest risk of cervical cancer with existing resources. It is usually planned at the national or regional level. An organized screening programme should specify: • the target population; • screening intervals; • coverage goals; • a mechanism for inviting women to attend screening services; • the screening test or tests to be used; • the strategies to ensure that all women found positive on screening are informed of their result; • a mechanism for referring women for diagnosis and treatment; • treatment recommendations; • indicators for monitoring and evaluating the screening programme. Opportunistic screening Opportunistic screening is screening done independently of an organized or population- based programme, on women who are visiting health services for other reasons. Screening may be recommended by a provider during a consultation, or requested by a woman. Opportunistic screening tends to reach younger women at lower risk, who are attending antenatal, child health and family planning services. It is generally accepted that organized screening is more cost-effective than opportunistic screening, making better use of available resources and ensuring that the greatest number of women will benefit. However, both organized and opportunistic screening can fail because of poor quality-control, low coverage of the population at risk, overscreening of low-risk populations, and high loss to follow-up. Benefits and risks of screening The benefits and risks of screening should be discussed with women as part of general health education and before obtaining informed consent. The benefits of screening have been described in previous chapters. However, as with all large efforts directed towards healthy populations, screening for cervical cancer has the potential to produce undesirable outcomes, such as: • psychological consequences – anxiety and fear about being tested for cancer; • a mistaken belief that a positive test is a cancer diagnosis; Chapter 4: Screening for Cervical Cancer 85 4 Chapter 4: Screening for Cervical Cancer • false positive test results (abnormalities reported in women whose cervix is normal), which may lead to unnecessary interventions and anxiety; • false negative test results (a normal screening test in women with cervical abnormalities); • identification of other illnesses, for which treatment may not be available. Following the recommendations in this Guide will, in general, help to minimize these undesirable outcomes. Target groups and frequency of screening Decisions on the target age group and frequency of screening are usually made at the national level, on the basis of local prevalence and incidence of cervical cancer, related factors such as HIV prevalence, and availability of resources and infrastructure. All existing data on recommended ages and frequency of screening are derived from experience in cytology programmes. To date, there are no comparable data from programmes using HPV-based and visual screening methods. When deciding on target age group and screening frequency, planners should take into account the following: • HPV infection is very common in young women, but most infections are transient. • Only a small percentage of all HPV infections will lead to invasive cancer. • Cervical cancer usually develops slowly, taking 10–20 years from early precancer to invasive cancer. • Cervical cancer is rare before the age of 30 years. Screening younger women will detect many lesions that will never develop into cancer, will lead to considerable overtreatment, and is not cost-effective. • Screening every three years is nearly as effective as yearly screening. If resources are limited, screening every 5–10 years – or even just once between the ages of 35 and 45 years – will significantly reduce deaths from cervical cancer. 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer86 Special considerations Before embarking on a widespread screening programme, national planners should ensure that the services needed to manage newly identified cancer cases are in place. To treat invasive cancer effectively, specialized facilities are needed; these must be in place before a screening programme is put into effect (see Chapter 6). If a population has not previously been screened, many cases of pre-existing cancer in different stages will be detected in a new screening programme. Women whose disease is very advanced, or for whom treatment is impossible for any reason, should receive palliative care (see Chapter 7). Screening in settings with high HIV prevalence In settings with high HIV prevalence, screening for cervical cancer is particularly important. HIV-positive women have more persistent HPV infections, and a higher incidence of cervical precancer and, in some settings, invasive cervical cancer. Where HIV is endemic, screening results may be positive in up to 15–20% of the target population. Cytology screening is equally effective in HIV-positive and HIV-negative women. Although HIV-infected women are at greater risk of precancer and cancer, screening, follow-up and treatment may not be a priority for the women themselves, who have competing health or social needs. All women, regardless of their HIV status, RECOMMENDED TARGET AGES AND FREQUENCY OF CERVICAL RECOMMENDED TARGET AGES AND FREQUENCY OF CERVICAL CANCER SCREENINGCANCER SCREENING • New programmes should start by screening women aged 30 years or more, and include younger women only when the higher-risk group has been covered. Existing organized programmes should not include women less than 25 years of age in their target populations. • If a woman can be screened only once in her lifetime, the best age is between 35 and 45 years. • For women over 50 years, a five-year screening interval is appropriate. • In the age group 25–49 years, a three-year interval can be considered if resources are available. • Annual screening is not recommended at any age. • Screening is not necessary for women over 65 years, provided the last two previous smears were negative. Chapter 4: Screening for Cervical Cancer 87 4 Chapter 4: Screening for Cervical Cancer should be encouraged to be screened for cervical cancer, provided that they have access to affordable services. Care should be taken not to link a positive cervical cancer screening test to HIV testing. However, a woman with precancer may benefit from knowing her HIV status, especially if antiretroviral treatment (ART) is available. Screening criteria for women with known HIV infection should be developed at the national level with these issues in mind. RECOMMENDATIONRECOMMENDATION Women should be offered the same cervical cancer screening options irrespective of their HIV status. Screening of pregnant women Not screening for cervical cancer during pregnancy is sometimes seen as a missed opportunity. Visits for antenatal care may be a good occasion for screening. However, integrating screening into routine antenatal care is not the best option for the following reasons: • Most pregnant women are younger than the target group. • In some cultures, pregnant women may be reluctant to undergo a gynaecological examination. • During pregnancy, interpretation of screening tests, such as cytological tests, is more difficult. • Regression of CIN during pregnancy is minimal, but there is a significant rate of spontaneous regression postpartum. • A biopsy for diagnosis should be taken from a pregnant woman only if invasive cancer cannot be ruled out. • Treatment of preinvasive disease is contraindicated during pregnancy. Women in the target age group who attend antenatal services should be advised to return for screening 12 weeks after giving birth. However, if a cervical abnormality is noted on speculum examination, or if the provider feels there is a risk that the woman will not return, she should be offered screening during the visit. In addition, the provider can suggest that the woman should encourage other women in the target age group in her extended family to be screened. 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer88 Screening family planning clientsScreening family planning clients Opportunistic cervical cancer screening is often integrated into family planning services. Family planning counselling provides a good opportunity to discuss the benefits of cervical cancer screening and a gynaecological examination is often more easily accepted during a reproductive health consultation. Screening should be encouraged and performed on clients of family planning services within the target age group. Contraceptive users do not need to be screened more often than other women, regardless of the method they use. Screening women with a reproductive tract or sexually transmitted infection (RTI/STI)Screening women with a reproductive tract or sexually transmitted infection (RTI/STI) Women in the target age group who present to health facilities with complaints suggestive of RTI/STI should be examined. They should be screened for cervical cancer only if there is no visible acute infection. If the speculum examination reveals evidence of acute infection, appropriate treatment should be given and cervical cancer screening should be deferred until after the infection has resolved. Health education and counselling on RTI/STI should include information on HPV infection, its relation to cervical cancer, and the protection offered by safer sex behaviours, including condom use. Male partners too should be treated, and counselled on cervical cancer prevention. STI services aimed primarily at men should include information on HPV and cervical cancer prevention. Other opportunities for cervical cancer screeningOther opportunities for cervical cancer screening Women at the end of their reproductive years are at greatest risk of cervical cancer, particularly if they have never been screened. They tend to use reproductive health services less often than younger women, but may use other health services, e.g. for management of hypertension, heart disease, diabetes or infectious diseases. In addition, women in the target age group may come to a health facility with a child or relative who needs services. All women in the target age group who visit a facility for any reason should receive information and be encouraged to come for screening (see also Chapter 3). General medical services at primary, secondary and tertiary levels can provide cervical cancer screening for such women, using on-site, trained providers. If this is not possible, women should be given health education and referred to a convenient screening clinic. No missed opportunitiesNo missed opportunities Cervical cancer screening programmes should also try to reach all women in the Cervical cancer screening programmes should also try to reach all women in the target age group who have contact with the health system for any reason. target age group who have contact with the health system for any reason. Chapter 4: Screening for Cervical Cancer 89 4 Chapter 4: Screening for Cervical Cancer Choice of screening test to be used The choice of screening test or tests to be used is usually made at the national or regional level. Nevertheless, providers should have some basic knowledge of all the available screening tests. Decisions on the test or tests to be used may be based on: • the organization of the health system; • the funds available; • the number and type of health workers; • the availability of laboratory services and transport; • the availability and cost of the various screening tests. The test used may also be determined based on the physical proximity of services to women; for example, it might be decided to use the Pap smear (which requires women to return for their test results) in urban areas and visual inspection with acetic acid (VIA) (for which results are immediately available) in more inaccessible rural areas in the same country. The most extensive and long-term experience in cervical cancer screening is with cytology, which has been used in numerous countries since the 1950s. Cytology-based screening and treatment programmes have reduced cervical cancer incidence and mortality by as much as 80% in Canada, the USA and some Nordic countries, and by 50–60% in other European countries. It has been difficult to replicate this success in low-resource settings, because of the inherent requirements of a cytology-based programme. These include highly trained personnel, well equipped laboratories, transport of specimens, and an effective system for collecting information and following up patients. In addition, the demands of other competing health needs often result in a lack of resources or political will to make cervical cancer screening a priority. Because of the problems of implementing quality cytology-based screening, alternative methods, such as visual inspection, have been developed. These methods have shown promise in controlled research settings but have not yet been widely implemented. Their ultimate impact on cervical cancer incidence and mortality will not be known until large ongoing population-based studies are completed. HPV-based tests are now also commercially available, but have disadvantages, including the need for sophisticated laboratory facilities and high cost. 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer90 Ethical issues Decisions on how best to use scarce resources have to weigh the extent of disability and death caused by different diseases, and the efficacy, cost and impact of diagnosing and treating them. While decisions about priorities are usually made at national level, providers should understand the reasons for the decisions, so that they are motivated to implement them and can explain them to their patients (see Chapter 1). If well planned and integrated into other sexual and reproductive health activities, screening for cervical cancer has the potential to both strengthen the health care system and improve the health of women, particularly women over childbearing age, whose health is often relatively neglected. Before a screening programme is implemented, the following elements should be considered to ensure an ethical and equitable approach: • Screening should be accessible to all women in the target group, including the poorest, most vulnerable, and hardest to reach. • Patients, providers and communities should receive health education to ensure informed decision-making on screening and treatment. • Patient record systems should ensure confidentiality. • Diagnostic tests, follow-up, and treatment should be available and accessible. • Providers should have clear guidelines on follow-up and management of women with positive screening results. • A referral system should be in place for other health problems, including gynaecological disorders, discovered during the screening process. Informed choice and Informed consent 7 Informed choice and informed consent are based on the ethical principles of autonomy and respect for the individual. In many cultures, the notion of consent may be a collective decision-making process involving others, such as partner, family, and village leaders. Accurate information provided through health education and counselling can ensure that women and their extended families understand the facts about cervical cancer, who is at risk, how screening can reduce risk, and any potential harm related to screening. Before consenting to screening, women should be given information on the specific test to be used, the meaning and consequences of a positive test, and the availability of treatment. In addition, when results are not available immediately (as they are with 7 Note: informed consent is not equivalent to informed choice. Consent refers to the explicit permission given by a person for a procedure or test, once she (or he) has received sufficient information to make a rational personal (informed) choice. Informed consent PS6 Chapter 4: Screening for Cervical Cancer 91 4 Chapter 4: Screening for Cervical Cancer visual screening methods), informed consent should include explicit permission to be contacted at home or at work. Respect for autonomy requires that the choice to be screened is voluntary and free of coercion. Client assessment All clients attending for screening should have a basic assessment before proceeding to the screening test. This assessment should include information and counselling, informed consent, a social and clinical history, and a physical examination. The history can provide useful information for guiding decisions about management or additional examinations or tests that might benefit the patient. Because of the stigma associated with genital problems, women are often reluctant to talk about their concerns or symptoms and signs. To establish and maintain trust and respect, confidentiality and privacy must be explicitly guaranteed to each woman who presents for screening before she is asked about her history. For cervical cancer screening, the essential components of the pelvic examination are visual inspection of the external genitals and a speculum examination. Providers should explain what is being done at each step during the examination; if an abnormality is noted, the provider should inform the woman without alarming her. Having female providers perform the physical examination, if possible, can greatly reduce reluctance to be examined and can play a major role in making screening acceptable. When the provider is a man, the woman may request that a female companion or clinic attendant is in the room. Sexual and reproductive health problems detected during history-taking and examination An integrated approach to management of sexual and reproductive health problems during screening can help improve the health of women, especially older women. The provider should pay particular attention to signs and symptoms suggestive of cancer, STI, or other diseases detected during history-taking and pelvic examination. In addition, women should be offered an opportunity to raise personal concerns regarding sexual and reproductive health issues. Women with abnormal findings can be treated or referred for further investigation, as appropriate. Infection prevention in cervical cancer screening In screening, as in all clinical activities, scrupulous attention should be given to infection prevention. Pathogens, including HIV, can be transmitted if guidelines on handwashing, handling of instruments, and disposal of used supplies, including gloves, are neglected. Counselling PS4 Pelvic exam PS7 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer92 Universal precautions (see Annex 1) against spreading infection should be used with all patients, whether they appear sick or well, and whether their HIV or other infection status is known or not. In this way, providers protect both their patients and themselves. Providers should use only uncontaminated instruments, and should wear latex gloves on both hands when performing speculum or bimanual examinations and taking specimens, and when performing procedures such as cryotherapy. SCREENING TESTS A good screening test should be: • accurate; • reproducible; • inexpensive; • easy to perform and easy to follow up; • acceptable; • safe. The following tests meet the above criteria to a greater or lesser extent: • cytology: conventional (Pap smear) and liquid-based; • HPV DNA test; • visual inspection: with acetic acid (VIA) or Lugol’s iodine (VILI). The performance of each test is described below. The strengths and limitations of the different tests are summarized in Table 4.1. Measurement and interpretation of performance characteristics are outlined in Annex 3. Cytology Conventional Pap smear In the Pap smear test, a sample of cells is taken from the transformation zone of the cervix using an extended-tip wooden spatula or brush; using a cotton swab is no longer recommended. The entire transformation zone should be sampled since this is where almost all high-grade lesions develop. The sample is then smeared onto a glass slide and immediately fixed with a solution to preserve the cells. The slide is sent to a cytology laboratory where it is stained and examined using a microscope to determine whether the cells are normal (Figure 4.1) and to classify them appropriately, using the Bethesda classification (see Annex 2). The results of the Pap smear are then reported to the clinic where the Infection prevention Annex 1 Test’s performance Annex 3 Bethesda system Annex 2 Pap smear PS8 Chapter 4: Screening for Cervical Cancer 93 4 Chapter 4: Screening for Cervical Cancer Figure 4.1 Graphic representation of normal and abnormal epithelial cellsFigure 4.1 Graphic representation of normal and abnormal epithelial cells specimen was taken. Health workers are responsible for ensuring that the woman is informed of her result and that she receives appropriate follow-up as outlined in Annex 4a. The Pap test takes less than 5 minutes to perform, is not painful, and can be done in an outpatient examination room. It is advisable to postpone taking a Pap smear if the woman is menstruating actively, has a clinically evident acute inflammation, or is pregnant. A satisfactory smear requires adequate numbers of well preserved squamous epithelial cells and an adequate endocervical/transformation zone component. Each smear should be legibly labelled. The accuracy of cytological testing depends on the quality of the services, including sampling practices (taking and fixing the smears), and preparation and interpretation of smears in the laboratory. Under the best conditions in developed countries or research settings, conventional cytology can detect up to 84% of precancer and cancer. However, under poor conditions its sensitivity can be as low as 38%. The specificity of the test is usually over 90%. Liquid-based cytology (LBC) This refinement of conventional cytology was introduced in the mid-1990s and is increasingly used in high-resource settings. Instead of smearing cervical cells on a slide, the provider transfers the specimen from a brush to a preservative solution. The specimen is sent to a laboratory where the slide is prepared. LBC is more expensive than conventional cytology and laboratory staff need to be specially trained. However, it appears to have a number of advantages over conventional methods. • The specimens obtained are more representative of the areas sampled with fewer false negatives. • There are fewer unsatisfactory specimens. • Each specimen requires a shorter interpretation time, leading to increased efficiency and cost-effectiveness. • The material collected can also be tested for HPV DNA. Annex 4a Annex 4a Normal squamous cell High grade lesion 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer94 Although, as yet, no randomized controlled trial comparing LBC with conventional Pap smear has been published, several studies have shown that LBC is more sensitive than Pap smear and has almost the same specificity. Providers After a short training course, any provider who knows how to do a speculum examination (nurse, auxiliary or assistant nurse, midwife, clinical officer, medical doctor) can take a Pap smear. Indications The following groups of women should be offered screening: • Any woman between the ages of 25 and 65 years, who has never had a Pap smear before or who had one 3 or more years ago (or according to national guidelines). • Women whose previous Pap smear was reported as inadequate or showed a mild abnormality. • Women who have abnormal bleeding, bleeding after intercourse or after the menopause, or other abnormal symptoms. • Women who have been found to have abnormalities on their cervix. Interpretation of smears Smears are read in a laboratory by trained cytotechnicians, under the supervision of a pathologist, who has final responsibility for the reported results. Correct interpretation of slides is crucial to a successful programme. To maintain proficiency and avoid fatigue, cytotechnicians should spend a maximum of 5 hours a day at the microscope and should review a minimum of 3000 slides per year. Quality assurance is crucial and should be established in all cytology laboratories. The two most commonly used methods are rapid review of all negative slides, and full rescreening of a 10% random sample of slides originally reported as negative. In both methods, the review is done by another cytotechnician, with confirmation of abnormal smears by the supervising pathologist. Current evidence shows that, of the two methods, rapid review of all negative smears is more effective and more cost-effective. Laboratories should be equipped to read a minimum of 15 000 smears annually.8 Therefore, cytology services should not be decentralized to primary health care clinics or to small laboratories. Reliable transport of slides and test results to and from the laboratory is essential. 8 Detailed information on cytology laboratories is beyond the scope of this Guide. Further information can be found in the references listed under “Additional resources” at the end of this chapter. Chapter 4: Screening for Cervical Cancer 95 4 Chapter 4: Screening for Cervical Cancer The speed with which results are sent to the health facility is an important eleThe speed with which results are sent to the health facility is an important ele-- ment of the quality of the laboratory service and the quality of care, and greatly ment of the quality of the laboratory service and the quality of care, and greatly affects women’s satisfaction with the service.affects women’s satisfaction with the service. RECOMMENDATIONRECOMMENDATION Cytology is recommended for large-scale cervical cancer screening programmes, if sufficient resources exist. HPV DNA-based screening methods New screening procedures are based on the detection of high-risk HPV DNA in vaginal or cervical smears. A sample of cells is collected from the cervix or vagina using a swab or small brush, and placed in a small container with a preservative solution. The specimen can be collected by a health care provider or by the woman herself, inserting a swab deep into the vagina. Studies comparing the two collection methods have shown that self-collection is less sensitive than provider-collection. In either case, the specimen containers are transported to a laboratory where they are processed. HPV DNA-based tests currently require sophisticated and expensive laboratory equipment, although work is under way to develop a more affordable and less complicated test that can be carried out in lower- level settings. Detection of high-risk HPV does not necessarily mean that precancer or cancer is present; it indicates simply that there is an HPV infection. As mentioned earlier, HPV infections are extremely common in women under 35 years, and most of them resolve spontaneously. When detection of HPV is used as a primary screening test, the sensitivity for detection of precancer and cancer varies from 50% to 95%, with most studies reporting high sensitivity of 85% or more. The specificity ranges from 50% to 95%, with an average of 84%. In women aged 35 years or older, HPV DNA tests perform better because in these women a positive test is more likely to be due to a persistent infection than in younger women. The average sensitivity and specificity in this group are 89% and 90%, respectively. The combination of cytology and HPV testing has very high sensitivity and negative predictive values approaching 100% (see Annex 3). It might therefore be possible to increase the interval between screenings for women who are negative on both tests. However, performing the two tests together is expensive. The high cost, and the need for both a molecular laboratory and reliable methods of transport, present major challenges, and the feasibility of HPV testing has not been demonstrated in low-resource settings. A new, faster, highly sensitive and less costly test for HPV is under development but is not yet available. HPV test PS9 Annex 3 Annex 3 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer96 Providers HPV DNA testing can be done by trained providers at any level of the health care system, provided that there is an appropriate laboratory within a reasonable distance, and that reliable transport is available for specimens. Clinic needs for HPV testing are the same as for Pap smears and visual methods. Indications HPV is not generally used on its own as the primary screening test. It is mainly used in combination with cytology to improve the sensitivity of the screening or as a triage tool to assess which women with borderline Pap results need to be referred for colposcopy. The main indication is a Pap result of “atypical cells of undetermined significance” (ASC-US). Of the women with this lesion, only those who test positive for high-risk HPV will need to be referred for colposcopy and biopsy, significantly reducing the number of colposcopies. Laboratory facilities The HPV laboratory requires a special clean room to avoid contamination, and highly trained technicians. It also requires equipment and reagents as specified by the manufacturers of the test. RECOMMENDATIONRECOMMENDATION HPV DNA tests as primary screening methods, at this time, are recommended for use only in pilot projects or other closely monitored settings. They can be used in conjunction with cytological or other screening tests, where sufficient resources exist. HPV DNA-based screening should not begin before 30 years of age. Visual methods Two visual methods are available: • visual inspection with acetic acid (VIA); • visual inspection with Lugol’s iodine (VILI). Abnormalities are identified by inspection of the cervix without magnification, after application of dilute acetic acid (vinegar) (in VIA) or Lugol’s iodine (in VILI). When vinegar is applied to abnormal cervical tissue, it temporarily turns white (acetowhite) allowing the provider to make an immediate assessment of a positive (abnormal) or negative VIA and VILI PS10 Chapter 4: Screening for Cervical Cancer 97 4 Chapter 4: Screening for Cervical Cancer (normal) result. If iodine is applied to the cervix, precancerous and cancerous lesions appear well-defined, thick, and mustard or saffron-yellow in colour, while squamous epithelium stains brown or black, and columnar epithelium retains its normal pink colour. Because they do not rely on laboratory services, VIA and VILI are promising alternatives to cytology where resources are limited. They are currently being tested in large, cross-sectional, randomized controlled trials in developing countries. Until data from these studies are available, VIA and VILI are recommended by WHO only for use in pilot settings, because the impact on cervical cancer incidence and mortality is still unproven. In research settings, VIA has been shown to have an average sensitivity for detection of precancer and cancer of almost 77%, and a range of 56% to 94%. The specificity ranges from 74% to 94% with an average of 86%. Low-level magnification does not improve the performance of VIA over and above that of naked eye visualization. One study has shown that VILI can detect 92% of women with precancer or cancer, a sensitivity considerably higher than that of either VIA or cytology. Its ability to identify women without disease is similar to that of VIA (85%), and lower than that of Pap smears. One study showed that VILI had a higher reproducibility than VIA. VIA and VILI can be performed in clinics and other outpatient facilities. They are both short procedures and cause no pain. Assessment is immediate, and no specimen is required. Advantages • VIA and VILI are relatively simple and can be taught to nurses, nurse-midwives and other health workers. • Assessment is immediate and no transport, or laboratory equipment or personnel, is needed. • The tests are likely to be less costly than other approaches in routine use. • Results are available immediately, eliminating the need for multiple visits in most cases, and reducing loss to follow-up. • They could potentially be used in an approach based on screening and treating women in a single visit (see Chapter 5). Disadvantages • Because of the low positive predictive value of the test (see Annex 3), a considerable number of women who test positive do not have disease, resulting in excessive diagnosis and treatment, and unnecessary anxiety. • Visual tests cannot be relied on in postmenopausal women, because the transformation zone of these women is often inside the cervical canal. Annex 3 Annex 3 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer98 • There is no permanent record of the test that can be reviewed later. • VIA has mostly been evaluated as a once-in-a-lifetime screening test, and its performance in periodic screening has not been assessed. Providers Trained nurses, nurse-midwives, nurse assistants, physicians and other health workers with adequate and ongoing support and supervision can perform VIA. Training takes 5–10 days using a competency-based approach. To maintain quality services, it is important that an experienced provider conducts regular assessments. Studies show that immediately after training, providers have more false positive results. These decrease in a few months as the providers gain experience. Indications If adopted by a programme as a screening method, VIA and VILI are indicated for all women in the target age group specified in national guidelines, provided that: • They are premenopausal. Visual methods are not recommended for postmenopausal women, because the transition zone in these women is most often inside the endocervical canal and not visible on speculum inspection. • Both squamocolumnar junctions (i.e. the entire transformation zone) are visible. If the patient does not meet the above indications and no alternative screening method is available in the particular clinical setting, she should be referred for a Pap smear. RECOMMENDATIONRECOMMENDATION Visual screening methods (VIA and VILI), at this time, are recommended for use only in pilot projects or other closely monitored settings. These methods should not be recommended for postmenopausal women. Chapter 4: Screening for Cervical Cancer 99 4 Chapter 4: Screening for Cervical Cancer Test Procedure Strengths Limitations Status Conventional cytology (Pap smear) Sample of cervical cells taken by provider and examined by trained cytotechnicians in a laboratory • History of long use • Widely accepted • Permanent record of test • Training and mechanisms for quality control established • Modest investments in existing programmes can improve services • High specificity • Results not immediately available • Systems needed to ensure timely communication of test results and follow-up of women • Transport required for specimen to laboratory and for results to clinic • Requires laboratory quality assurance • Moderate sensitivity • Available in many countries since the 1950s • Cytology- based programmes have reduced cancer mortality in developed countries Liquid-based cytology (LBC) Sample of cervical cells is obtained with a small brush, immersed in special liquid and sent to laboratory for processing and screening • Fewer inadequate or unsatisfactory samples requiring patient call-back and rescreening • Once cytotechnicians are proficient, LBC samples take less time to review • Samples can be used for molecular testing (such as for HPV) • Results not immediately available • Supplies and laboratory facilities more expensive than for conventional cytology • No controlled studies, to date, comparing sensitivity and specificity with conventional cytology Selected as screening method in some developed countries (e.g. United Kingdom) continued next page Table 4.1 Summary of characteristics of screening methods for cervical cancer 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer100 Test Procedure Strengths Limitations Status HPV DNA testing Molecular testing for HPV – swab taken by provider or woman herself and sent to laboratory • Collection of specimen simple • Automated processing • Can be combined with Pap smear to increase the sensitivity, but this increases also the cost • A negative test means no HPV and related morbidity is present • The assay result is a permanent record • High specificity in women over age 35 • Results not immediately available • High unit cost • Complex laboratory requirements and specimen transport • Low specificity in young women leading to overtreatment • Storage of reagents problematic • Commercially available and used in some developed countries in addition to cytology • Lower-cost tests in development Visual methods (VIA and VILI) Trained provider examines cervix after staining with vinegar (in VIA) and with Lugol’s iodine (in VILI) • Relatively simple and inexpensive • Results available immediately • Can be performed by wide range of personnel after short training • Low level of infrastructure required • Can be combined with offer of immediate treatment in single-visit approach • High provider variability • Lower specificity resulting in high referral rate and overtreatment • No permanent record of test • Not appropriate for postmenopausal women • Lack of standardization • Frequent retraining needed • Limited evidence available • Only recommended at this time for use in demonstration projects • Large randomized controlled trials under way to determine effect on cancer incidence and mortality Continued from page 99 Table 4.1 Summary of characteristics of screening methods for cervical cancer Chapter 4: Screening for Cervical Cancer 101 4 Chapter 4: Screening for Cervical Cancer FOLLOW-UP Follow-up and management of women with an abnormal (positive) test Screening by itself will not prevent a single case of cervical cancer. An effective system for follow-up and treatment of women who test positive is perhaps the most important component of a successful cervical cancer prevention programme. Ideally, all women should receive the results of their test, whether negative or positive. In practice, resources will sometimes be too limited to allow this. At the very least, women whose test result is positive or abnormal must be informed of the result and of what follow-up is needed. Follow-up should be in line with national protocols or based on the recommendations found in Annex 4. Follow-up is essential for the woman’s welfare and for the success of the programme and every effort should be made to contact women with positive test results. The following actions will help ensure that women with an abnormal screening test can be reached for follow-up: • The woman’s address, or other information on how she can be reached, should be noted at the time of screening (with her consent). • During counselling and after screening, providers need to emphasize the importance of coming back for results and follow-up care. • Every clinic should have a directory of all women with abnormal test results, with an indication of whether they have received the results and been followed up. Clinics should designate someone to ensure that follow-up is done. For women who do not return spontaneously as advised, providers can: • send a letter by mail; • telephone women at home or at work; • ask community health workers to contact women directly at home. Health care managers and providers can develop other locally appropriate approaches to reach women with abnormal screening tests. Health facilities need to make every effort to find women with abnormal results if Health facilities need to make every effort to find women with abnormal results if they do not return for scheduled appointments.they do not return for scheduled appointments. Flowchart screening Annex 4 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer102 Record-keeping Records should be compatible throughout a country, so that all the data collected by the cervical cancer control programme can be compared. The information system should include every woman’s clinical record, appointments scheduled, and those kept or missed. This can be a simple paper record or can be computer-based. A logbook can be used to register women screened and record their test results. If women need to return later for their results, a system must be in place to ensure that those with abnormal results are notified and that women who are hard to locate are traced. Sample forms for follow-up can be found in Annex 7. Documents Annex 7 Chapter 4: Screening for Cervical Cancer 103 4 Chapter 4: Screening for Cervical Cancer • Educate and inform the community, promote the screening programme, and encourage women to attend. • Refer appropriate women for screening. • Assist women to attend screening clinics. • Assist in follow-up of women with a positive screening to ensure that they return to the clinic for management. • Screen, using methods specified by national guidelines and integrating screening into other services. • Train, support and supervise CHWs. • Work with CHWs to educate women, and recruit them for screening. • Participate in campaigns to bring women at high risk for testing. • Provide counselling and health education in the clinic and community. • Inform and counsel women with positive screening test results, and advise them on needed follow-up, diagnosis and treatment. • Implement an accurate patient information system, to allow proper tracking and follow-up of women after treatment. • Carry out screening activities as per national programme. • Inform and counsel women with positive screening test results, and advise them on needed follow-up, diagnosis and treatment. • Train, support and supervise providers at health centre level. • Manage referral systems with lower and higher levels of the health system. • Carry out screening in outpatient clinics where women are seen. • Maintain central cytology, pathology, and molecular laboratories, as feasible. • Interpret screening and histopathology results and ensure that results reach the screening site. • Train medical personnel, and support and supervise providers in lower-level health facilities. • Manage referral and links with lower levels of the health system. SCREENING ACTIVITIES AT DIFFERENT LEVELS OF THE HEALTH SYSTEM In the community At the health centre At the district hospital At the central hospital 4 Chapter 4: Screening for Cervical Cancer Chapter 4: Screening for Cervical Cancer104 Counselling messagesCounselling messages Women who have just had a screening test need to be told: • if anything abnormal was noted; • when the results will be available; • the date of the next appointment. Women returning for test results should be counselled on: • the result of the test and what it means; • if normal, when they need to return for repeat screening; • if inadequate or not normal, what follow-up is needed; • where and when to go for follow-up. Chapter 4: Screening for Cervical Cancer 105 4 Chapter 4: Screening for Cervical Cancer ADDITIONAL RESOURCES • ACCP. Planning and implementing cervical cancer prevention programs: a manual for managers. Seattle WA, Alliance for Cervical Cancer Prevention, 2004. • Arbyn M. A technical guideline: collection of adequate Pap smears of the uterine cervix. Brussels, Scientific Institute of Public Health, 2001. • Cervical cancer prevention: guidelines for low-resource settings. Baltimore, MD, JHPIEGO Corporation, 2001. • CHIP. Implementing cervical screening in South Africa. Volume I. A guide for programme managers. New York, Cervical Health Implementation Project, South Africa, University of Cape Town, University of the Witwatersrand, EngenderHealth, 2004. • IARC. A practical manual on visual screening for cervical neoplasia. Lyon, IARCPress, 2003. • IARC. Cervix cancer screening. Lyon, IARC Press, 2005 (IARC Handbooks of Cancer Prevention, Volume 10). • Infection prevention: a reference booklet for health care professionals. New York, EngenderHealth, 2001. • Infection prevention curriculum: a training course for health care providers and other staff at hospitals and clinics. New York, EngenderHealth, 1999. • Miller AB. Cervical cancer screening programmes, managerial guidelines. Geneva, WHO, 1992. • PATH. Planning appropriate cervical cancer prevention programs. Seattle, WA, Program for Appropriate Technology in Health, 2000. • PATH VIA/VILI curriculum. Course in visual methods for cervical cancer screening. In: Tsu V et al., Western Kenya Cervical Cancer Prevention Project Final Report. Seattle, WA, Program for Appropriate Technology in Health, 2004 (Annex 10). • Salas Diehl I, Prado Buzeta R, Muñoz Magna R. Manual de Procedimientos de Laboratorio de Citología. Washington, DC, Organización Panamericana de la Salud, 2002. • WHO. Cervical cancer screening in developing countries. Report of a WHO Consultation. Geneva, 2002. 106 107PS 6: Obtaining Informed Consent Practice Sheet 6: Obtaining Inform ed Consent PS 6 PRACTICE SHEET 6: OBTAINING INFORMED CONSENTPRACTICE SHEET 6: OBTAINING INFORMED CONSENT WHAT IS INFORMED CONSENT? Women must give informed consent before being screened for cervical cancer. This means that she should understand what is to take place, including the potential risks and complications of both proceeding and not proceeding, and has given permission for the procedure. It should be made clear to the woman that there will be no punitive action if she refuses the procedure. When asking for informed consent: • Give the woman all essential information on what you are about to do and request her consent before starting any examination or procedure. It is unethical to ask for informed consent retroactively. • If there is a possibility that she might need to be contacted at home or at work (e.g. to give test results or remind her to return for an appointment), obtain consent for doing so. • Family members should be included in the discussion only if the woman has given explicit permission. • Keep medical terminology to a minimum. Explain any technical words that have no local equivalent. • You may find it helpful to draw or use pictures to illustrate your explanations. • Be clear and direct; do not use words the patient will not understand, or which are vague, such as “growth” or “neoplasm”. • Do not confuse the woman by saying too much, but cover all the important issues. • Allow some time for the woman to take in what you have said. Then let her ask questions. When all the questions have been addressed, ask the woman for her formal consent. • It might be culturally important to include others, such as the woman’s partner, in the decision-making process; however, you should ensure that the woman’s wishes are respected. ExPLAINING PRACTICES AND PROCEDURES You will find explanations for patients included in each chapter of this Guide and in the practice sheets. You may adapt these to individual situations to help explain procedures in terms the patient and her family understand. 108 PS 6: Obtaining Informed Consent PS 6 Practice Sheet 6: Obtaining Inform ed Consent STEPS FOR OBTAINING INFORMED CONSENT Preparation 1. Ensure privacy and explain that confidentiality is always respected in your facility. 2. Follow your facility’s regulations on obtaining informed consent. 3. Apply general rules on counselling and good communication. Listen carefully and address the woman’s concerns; give her the time she needs to understand and to make a decision. 4. Ask her if she would like to have family members present or if she would like to discuss the decision with family members at home. Do not pressure her to make a decision before she is ready. Process 5. Give all the necessary information on the test, procedure or treatment you are recommending and any available alternatives. Use the explanations for patients included in this Guide, adapted to your facility and the individual situation, to help explain procedures such as cryotherapy, surgery, and radiotherapy. Include the following information: • purpose of the procedure; • possible benefits; • risks of doing what you suggest and of not doing it; • need for anaesthesia or hospitalization; • potential side-effects and complications and what to do if any of them occur; • recovery time; • cost; • chance of success or failure. 6. Ask the woman if she has any questions, and answer them. 7. Check that the patient has understood. You can do this by asking her to repeat points that may be difficult or important, or by using other words to reiterate the most important issues, such as: “Did you understand that you should not have intercourse for 4 weeks after this procedure? How do you think your husband will feel about that?” 8. Correct any misunderstanding. 9. Keep a written record, either on a consent form or in the medical record (according to your facility’s guidelines), that: • you confirmed her understanding of the information; • her decision to undergo a test or treatment (or to refuse it) was voluntary. Counselling PS4 PS 7: Taking a History and Performing a Pelvic Examination PS 7 Practice Sheet 7: Taking a History and Perform ing a Pelvic Exam ination 109 PRACTICE SHEET 7: TAKING A HISTORY AND PERFORMING PRACTICE SHEET 7: TAKING A HISTORY AND PERFORMING A PELVIC ExAMINATION A PELVIC ExAMINATION 99 Cervical cancer screening includes taking a history, to assess if the woman has specific risk factors or suggestive symptoms. Most screening tests involve a speculum examination. The following equipment and supplies should be available: • clinical chart and pencil; • drawings of pelvic organs, if possible; • soap and water for washing hands; • light source to examine the cervix; • examination table covered by clean paper or cloth; • disposable or high-level disinfected examination gloves; • specula of different sizes, high-level disinfected (need not to be sterile); • small container of warm water to lubricate and warm the speculum; • 0.5% chlorine solution for decontaminating instruments and gloves. HISTORY Ask the patient about: • her age, education, number of pregnancies, births and living children, last menstrual period, menstrual pattern, previous and present contraception; • previous cervical cancer screening tests, their dates and results; • medical history including any medications or drug allergies; • social history, including factors that may increase her risk of cervical cancer; • sexual history including age of sexual initiation and of first pregnancy, number of partners, previous STIs, and any behaviours that may suggest an increased risk of cervical cancer; • any symptoms and signs of cervical cancer and other illnesses. 9 Adapted from: Burns A et al. Where women have no doctor. Berkeley, CA, Hesperian Foundation, 1997; and WHO. Sexually transmitted and other reproductive tract infections: a guide to essential practice. Geneva, 2005. Practice Sheet 7: Taking a History and Perform ing a Pelvic Exam ination 110 PS 7 PS 7: Taking a History and Performing a Pelvic Examination PERFORMING A PELVIC ExAMINATION After taking a history, perform a pelvic examination. There are three components to the female genital examination: • an external genital examination; • a speculum examination; • a bimanual examination. Before the examination 1. Have all necessary equipment and supplies ready. Ensure the speculum used is at a comfortable temperature. 2. If tests or interventions are planned (e.g. a Pap smear), tell the woman what they are, what they are for, and when you expect to have the results. 3. Ask the woman if she has any questions, and answer them truthfully. 4. Explain what the pelvic examination consists of and show the woman a speculum. 5. Ask the woman to empty her bladder (urinate) and have her undress from the waist down. Be particularly sensitive to her sense of modesty about uncovering normally clothed areas, or if the examination is perceived to be invasive. 6. Position the woman on the examination table. Examination of the external genital area 7. Using a gloved hand to gently touch the woman, look for redness, lumps, swelling, unusual discharge, sores, tears and scars around the genitals and in between the skin folds of the vulva. These can be signs of a sexually transmitted infection. PS 7: Taking a History and Performing a Pelvic Examination PS 7 Practice Sheet 7: Taking a History and Perform ing a Pelvic Exam ination 111 8. Hold the speculum blades together sideways and slip them into the vagina. Be careful not to press on the urethra or clitoris because these areas are very sensitive. When the speculum is halfway in, turn it so the handle is down. Gently open the blades and look for the cervix. Move the speculum slowly and gently until you can see the entire cervix. Tighten the screw (or otherwise lock the speculum in the open position) so it will stay in place. 9. Check the cervix, which should look pink, round and smooth. There may be small yellowish cysts, areas of redness around the opening (cervical os) or a clear mucoid discharge; these are normal findings. 10. Look for any abnormalities, such as: a. Vaginal discharge and redness of the vaginal walls, which are common signs of vaginitis. If the discharge is white and curd-like, there is probably a yeast infection. b. Ulcers, sores or blisters. Genital ulcers may be caused by syphilis, chancroid, herpes virus or, in some cases, cancer. Sores and blisters are usually caused by herpes virus. c. Easy bleeding when the cervix is touched with a swab, or a mucopurulent discharge, which are signs of a cervical infection. d. An abnormal growth or tumour, which might be cervical cancer. 11. Gently pull the speculum towards you until the blades are clear of the cervix, close the blades and remove the speculum. The speculum examination cervix Practice Sheet 7: Taking a History and Perform ing a Pelvic Exam ination 112 PS 7 PS 7: Taking a History and Performing a Pelvic Examination The bimanual examination The bimanual examination allows you to feel the reproductive organs inside the abdomen. 12. Test for cervical motion tenderness. Put the pointing and the middle finger of your gloved hand in the woman’s vagina. Turn the palm of your hand up. Feel the cervix to see if it is firm and round. Then put one finger on either side of the cervix and move the cervix gently while watching the woman’s facial expression. If this causes pain (you may see the woman grimace), this indicates cervical motion tenderness, and she may have an infection of the womb, tubes or ovaries (pelvic inflammatory disease or PID). If her cervix feels soft, she may be pregnant. 13. Feel the womb by gently pushing on her lower abdomen with your other hand. This moves the womb, tubes and ovaries closer to the fingers inside her vagina. The womb may be tipped forwards or backwards. When you find the womb, feel for its size and shape. It should feel firm, smooth and smaller than a lemon. • If the womb feels soft and large, the woman is probably pregnant. • If it feels lumpy and hard, she may have a fibroid or other growth. • If it hurts her when you touch it, she may have an infection. • If it does not move freely, she may have scars from an old infection. PS 7: Taking a History and Performing a Pelvic Examination PS 7 Practice Sheet 7: Taking a History and Perform ing a Pelvic Exam ination 113 14. Feel the tubes and ovaries. If these are normal, they will be hard to feel. If you feel any lumps that are bigger than an almond or that cause severe pain, she may have an infection or other condition needing urgent treatment. If she has a painful lump, and her period is late, she may have an ectopic pregnancy; in this case, she needs medical help right away. 15. Move your finger to feel the inside of the vagina. Make sure there are no unusual lumps, tears or sores. 16. Ask the woman to cough or push down as if she were passing stool. Look to see if something bulges out of the vagina. If it does, she may have a fallen womb or fallen bladder (prolapse). After the examination 17. Place used equipment and gloves in decontamination solution. 18. Wash your hands with soap and water. 19. Record all findings on the woman’s chart. 20. Tell the woman if her examination was normal or if you noted anything unusual or abnormal, and explain what any abnormality you noted might mean. 21. If you noted any signs that might indicate a sexually transmitted infection, treat the woman and her partner immediately, according to national or WHO guidelines.10 Provide condoms and teach them how to use them. If you found an acute cervical infection or PID, provide treatment as outlined in Annex 8. 22. If you found something that needs urgent treatment or that cannot be handled at your centre (e.g. ectopic pregnancy, prolapse, cervical tumour), refer the woman to a higher level of care. 23. Give her a date to return for follow-up if necessary. 10 WHO. Sexually transmitted and other reproductive tract infections: a guide to essential practice. Geneva, 2005. Annex 8 Annex 8 Practice Sheet 7: Taking a History and Perform ing a Pelvic Exam ination 114 PS 7 PS 7: Taking a History and Performing a Pelvic Examination PS 8: Taking a Pap Smear PS 8 PS 8: Taking a Pap Sm ear 115 PRACTICE SHEET 8: TAKING A PAP SMEARPRACTICE SHEET 8: TAKING A PAP SMEAR In a Pap smear test, a sample of cells is taken from the uterine cervix using a spatula or brush (see figure PS8.1), smeared onto a slide, and examined under a microscope for abnormal cells (precancer or cancer). When a Pap smear shows abnormal epithelial cells, it is reported as positive. Most women with a positive Pap smear need more tests to confirm the diagnosis and to determine whether treatment is needed.11 The following materials and equipment are needed for taking a conventional Pap smear: • soap and water for washing hands; • a light source to examine the cervix; • an examination table covered by clean paper or cloth; • a speculum, high-level disinfected (it need not be sterile); • disposable or high-level disinfected examination gloves; • an extended-tip wooden or plastic spatula (or another device for sampling); • a glass slide with frosted edge and pencil for labelling; • fixative solution; • recording form; • small container of warm water to lubricate and warm the speculum; • 0.5% chlorine solution for decontaminating instruments and gloves. Figure PS8.1 Devices for Pap smear samplingFigure PS8.1 Devices for Pap smear sampling (a) Wooden spatula (b) Endocervical brush (c) Plastic brush / broom 11 When the Pap smear reports ASC-US or LSIL, only persistent lesions (reported on two Pap smears within 6 months to 1 year) should be investigated further. PS 8 PS 8: Taking a Pap Smear 116 TAKING A PAP SMEAR Note the following: • It is best not to take a smear from women who are actively menstruating or have symptoms of an acute infection. Slight bleeding is acceptable. • Pregnancy is not an ideal time for a Pap smear, because it can give misleading results. However, if the woman is in the target age group and it is likely that she will not return after giving birth, proceed with the smear. Use Practice Sheet 4 to give counselling before doing any examination, test or procedure. Counselling steps specific to taking smears are included in the steps below. Preparation 1. Explain the procedure, what the test results mean, and why it is important to return for the test results and act on them appropriately. Ensure that the woman has understood and obtain informed consent. 2. Do a speculum examination as described in Practice Sheet 7. Taking the smear with a wooden spatula 3. Insert the long tip of the spatula into the os, and rotate it through a full circle (360 degrees). PS 8: Taking a Pap Sm ear Figure PS8.2 Taking a sample of cervical cells with a wooden spatulaFigure PS8.2 Taking a sample of cervical cells with a wooden spatula 4. Smear both sides of the spatula onto the glass slide with one or two careful swipes. If you see any abnormalities outside the area sampled, take a separate specimen and smear it on another slide. PS7 Pelvic exam PS7 Informed consent PS6 Counselling PS4 PS 8: Taking a Pap Smear PS 8 PS 8: Taking a Pap Sm ear 117 5. Immediately fix each slide. Either use spray fixative, at a right angle to, and a distance of 20 cm from, the slide, or immerse the slide in a container of 95% ethanol for at least 5 minutes. Figure PS8.3 Fixing a conventional Pap smearFigure PS8.3 Fixing a conventional Pap smear If the slide is not fixed immediately, the cells will dry and become misshapen; it will then not be possible to read the slide accurately in the laboratory. 6. Gently close and remove the speculum. 7. Place all used instruments in decontamination solution. After taking the smear 8. Label the frosted edge of each slide carefully with the woman’s name and clinic record number, and the date. 9. On the patient record, note and illustrate any features you have noted: visibility of the transformation zone, inflammation, ulcers or other lesions, abnormal discharge. Note whether other samples were taken, for example Pap smear of other areas, any STI tests and, if the woman has been referred elsewhere, to whom and when. 10. Ask the woman if she has any questions. 11. Tell her when and how she will receive the test results and stress the importance of returning for her results. Ideally, results should be sent to the clinic within 2 or 3 weeks. It is not acceptable for the laboratory to take more than 1 month before reporting back. 20 c m PS 8 PS 8: Taking a Pap Sm ear PS 8: Taking a Pap Smear 118 12. If you saw something for which you wish to refer the woman to a higher level, explain why, where and when she must go, and whom to see; stress the importance of keeping this appointment. 13. Suggest

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