PRE-PUBLICATION COPY ii PRE-PUBLICATION COPY i Tuberculosis PREVALENCE SURVEYS: a handbook second edition PRE-PUBLICATION COPY www.who.int/tb/advisory_bodies/impact_measurement_taskforce/resources_documents/thelimebook/en/index.html ii PRE-PUBLICATION COPY Contents ABBREVIATIONS v ACKNOWLEDGEMENTS vi INTRODUCTION TO THE 2nd EDITION vii PART I – Rationale and objectives 1 CHAPTER 1. WHAT, WHY, WHERE AND HOW? 3 1.1 What is TB prevalence and what is a TB prevalence survey? 3 1.2 Why are prevalence surveys important? 4 1.3 Where should prevalence surveys be carried out? 8 1.4 What are the essential ingredients for a successful survey? 13 CHAPTER 2. SURVEY GOAL, OBJECTIVES AND INDICATORS 19 2.1 Survey goal 19 2.2 Survey objectives 20 2.3 Survey indicators 24 PART II – Design and methods 27 CHAPTER 3. PROTOCOL DEVELOPMENT AND STANDARD OPERATING PROCEDURES 29 3.1 Protocol development process 29 3.2 Essential components of the protocol 30 3.3 Standard operating procedures 37 CHAPTER 4. SCREENING STRATEGIES AND CASE DEFINITIONS 39 4.1 Introduction 39 4.2 Measurement and case definitions 40 4.3 Screening tools and strategies 44 CHAPTER 5. SAMPLING DESIGN 51 5.1 Sampling methodology for TB prevalence surveys 56 5.2 Sample size determination and definition of terms 57 5.3 Selection of clusters and selection of individuals within clusters 71 PRE-PUBLICATION5.4 Definition of the eligible survey population COPY74 CHAPTER 6. INTERVIEWS, DATA COLLECTION TOOLS AND INFORMED CONSENT 81 6.1 What is the purpose of the interview? 81 6.2 Informed consent 82 6.3 Types of data collection tools 84 6.4 Questionnaire design 91 i 6.5 Administering questionnaires 92 6.6 Quality assurance of questionnaires 93 CHAPTER 7. CHEST RADIOGRAPHY 95 7.1 Introduction 95 7.2 X-ray technique, limitations and recent advances 96 7.3 Epidemiological value of chest X-ray 98 7.4 X-ray technology and equipment 99 7.5 Choice of equipment 102 7.6 Radiation safety 104 7.7 Staff 106 7.8 Interpretation 107 7.9 Training 108 7.10 Field work 108 7.11 Practical issues and tips 110 7.12 Quality assurance 114 7.13 Management of imaging data 115 CHAPTER 8. BACTERIOLOGY 117 8.1 Introduction 117 8.2 Specimen collection and management 118 8.3 Choice of laboratory tests 120 8.4 Laboratory capacity 127 8.5 Training laboratory staff 128 8.6 Laboratory supplies 129 8.7 Archiving and storage of cultures 129 8.8 Safety 129 8.9 Internal and external quality assurance 130 CHAPTER 9. REPEAT SURVEYS 135 9.1 Introduction 135 9.2 Standardization between surveys 135 9.3 Sample size calculation 137 9.4 Analysis 146 CHAPTER 10. ETHICAL CONSIDERATIONS 153 PRE-PUBLICATION10.1 Introduction COPY153 10.2 Ethical principles 153 10.3 Review by an ethics committee 154 10.4 Informed consent 157 10.5 Some specific ethical issues that arise in TB surveys 158 ii CHAPTER 11. TB TREATMENT, HIV TESTING AND OTHER CRITICAL INTERVENTIONS 161 11.1 Management and follow-up of confirmed or suspected TB 161 11.2 HIV testing 161 11.3 Management and follow-up of abnormalities 163 CHAPTER 12. BUDGETING AND FINANCING 167 12.1 What is the total budget required for a prevalence survey? 167 12.2 Major factors that influence the size of the required budget 167 12.3 Typical components of a budget for a prevalence survey 170 12.4 Why the budget may underestimate or exaggerate the true cost of a survey? 173 12.5 Sources of funding for prevalence surveys 174 PART III – Management, organization, logistics and field work 177 CHAPTER 13. SURVEY ORGANIZATION AND PLANNING 179 13.1 Line of supervision for survey activities 179 13.2 Advisory groups 181 13.3 Qualifications and tasks for survey staff 182 13.4 Staff recruitment 186 13.5 Training 187 13.6 Technical assistance 189 CHAPTER 14. FIELD OPERATIONS 193 14.1 Timelines 193 14.2 Standard operating procedures 194 14.3 Mobilization and involvement of local government and communities 195 14.4 Field activities 197 CHAPTER 15. DOCUMENTS AND DATA MANAGEMENT 209 15.1 Introduction 209 15.2 Documents 210 15.3 Organizational aspects of data management 212 15.4 Procedures and data logistics 214 15.5 Tools 223 PART IV – Analysis and reporting 231 CHAPTERPRE-PUBLICATION 16. ANALYSIS AND REPORTING COPY233 16.1 Introduction 233 16.2 Description and assessment of completeness and internal consistency 234 of core data 16.3 Estimation of pulmonary TB prevalence; methods of analysis 249 16.4 Estimation of pulmonary TB prevalence; presentation of results 259 16.5 Summary and conclusions 264 iii PART V – Appendices 265 1. Social determinants and risk factors 265 2. Drug susceptibility testing in population-based TB prevalence surveys 279 6. Examples of questionnaires 282 6.1 Screening questionnaire 282 6.2 Questionnaire for participants eligible for sputum examination 283 6.3 Questionnaire to understand why cases are missed by the NTP 287 7.1 Chest X-ray fact-sheet for survey participants 289 7.2 Staff requirement for chest X-ray team 291 7.3 Interpretation of chest X-ray at central level 291 7.4 X-ray equipment check-list 293 10.1 Example check-list for submission of a TB prevalence survey 294 protocol to an Ethical Review Committee 10.2 10 steps for obtaining informed consent in practice 298 12.1 Template example for budget of a prevalence survey 299 13. Institutional affiliations of authors 302 PRE-PUBLICATION COPY iv abbreviations ALARA as low as reasonably achievable BSC biosafety cabinet CI confidence interval CPC cetylpyridinium chloride CR computer radiography CRRS chest radiograph reading and recording system DDR direct digital radiography DMA data management unit DR direct radiography DSM direct smear microscopy DST drug susceptibility testing EA enumeration area FM fluorochrome-stained GIS geographical information systems HIV human immunodeficiency virus IEC information, education and communication IPW inverse probability weighting IT information technology LCC life-cycle concept LGA local government area LQAS lot quality assurance sampling MAR missing at random MCAR missing completely at random MDG Millennium Development Goal MGIT mycobacteria growth indicator tube MIC minimal inhibiting concentration MI missing imputation MMR mass miniature radiography MNAR missing not at random MOTT mycobacterium other than tuberculosis NTM nontuberculous mycobacteria NTP national tuberculosis control programme (or equivalent) ODBC open database connectivity OR odds ratio PDA personal digital assistant PIN personal identification number PPE personal protective equipment PSU primary sampling unit SD standard deviation SE standard error SOP standard operating procedure PRE-PUBLICATIONSQL structured query language COPY SRL supranational reference laboratory SSU secondary sampling unit TAG technical advisory group TB tuberculosis UNICEF United Nations Children’s Fund UNOPS United Nations Office for Project Services USAID United States Agency for International Development WHO World Health Organization ZN Ziehl-Neelsen v acknowledgements This book is the result of a major collaborative effort involving 49 authors (from 16 institutions from all over the world) with extensive experience and expertise in leading, managing and supporting the design, implementation, analysis and reporting of tuberculosis prevalence surveys. A full list of authors with their institutional affiliations is provided in Appendix 13. The book was produced as one of the top priorities of the WHO Global Task Force on TB Impact Measurement in 2010, and specifically the Task Force’s subgroup on prevalence surveys. This subgroup is led by Ikushi Onozaki. The production of the book was led by a core group of 14 people. Each of these people made a major contribution to shaping the final content of the entire book and almost all of them were lead or contributing authors of multiple chapters. In alphabetical order, the group consisted of Helen Ayles, Ana Bierrenbach, Chen-Yuan Chiang, Katherine Floyd, Sian Floyd, Philippe Glaziou, Eveline Klinkenberg, Frank van Leth, Eugene McCray, Fulvia Mecatti, Ikushi Onozaki, Charalambos Sismani- dis, Marieke van der Werf and Norio Yamada. Overall coordination of the production of the book was provided by Charalambos Sismanidis, with broad guidance from Katherine Floyd. Inés Garcia, Petra Haas, Nico Kalisvaart, Narayan Pendse, Andreas Reis and Ab Schaap were lead authors of individual chapters. Isolde Birdthistle and Emily Bloss contributed material to multiple chapters. Thomas Anthony, Nulda Beyers, Frank Bonsu, Rhian Daniel, Mary Edginton, Donald Enar- son, Haileyesus Getahun, Christopher Gilpin, Jean Iragena, Ernesto Jaramillo, Nancy Kaas, Sang Jae Kim, Tandar Lwin, Patrick Moonan, Monde Muyoyeta, Hoa Nguyen Binh, Sai Pothapregada, John Puvimanasinghe, Peou Satha, Abha Saxena, Kwame Shanaube, Masja Straetemans, Edine Tiemers- ma, Hazim Timimi and Veronique Vincent contributed material to individual chapters. Knut Lonnroth coordinated the production of Appendix 1 on the study of risk factors. Wayne van Gemert wrote Appendix 2 on drug resistance testing. All authors, as well as many external peers, have critically reviewed the book and provided valuable input. The following individuals developed material for the first edition of this book, which also feature within Appendix 1 of this second edition: Julia Critchley and Nigel Unwin (diabetes), Eva Rehfuess (indoorPRE-PUBLICATION air pollution), Kristen Hassmiller (tobacco use) and Elizabeth Corbett (silicosis).COPY The authors would also like to thank Jaap Broekmans for his excellent chairmanship of meetings among lead authors, Karen Ciceri for her thorough and highly efficient editing of the entire book, Rania Spatha for her dedicated and high-quality work on the design and layout, and Pamela Baillie, Victoria Birungi and Tracy Mawer for their invaluable administrative support. The principal sources of financial support for preparing this publication were the governments of vi the Netherlands and Japan, and USAID. Introduction The first edition of this book – Assessing tuberculosis prevalence through population-based -sur veys – was published by the World Health Organization (WHO) in 2007.