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Centre for Reviews and Dissemination Diagnostic Accuracy and Cost Centre for Reviews and Dissemination Diagnostic Accuracy and Cost-Effectiveness of Faecal Occult Blood Tests Diagnostic Accuracy and Cost-Effectiveness of Faecal Occult Blood Tests Used in Screening for Colorectal Cancer: A Systematic Review 36 Promoting the use of research based knowledge REPORT 36 CRD DIAGNOSTIC ACCURACY AND COST-EFFECTIVENESS OF FAECAL OCCULT BLOOD TESTS (FOBT) USED IN SCREENING FOR COLORECTAL CANCER: A SYSTEMATIC REVIEW Karla Soares-Weiser1 Jane Burch 1 Steven Duffy1 James St John2 Stephen Smith Marie Westwood1 Jos Kleijnen1 1 Centre for Reviews and Dissemination, University of York, York 2 The Cancer Council Victoria, Melbourne, Australia 3 University Hospitals of Coventry & Warwickshire, Coventry February 2007 © 2007 Centre for Reviews and Dissemination, University of York ISBN 978-1-900640-44-2 This report can be ordered from: Publications Office, Centre for Reviews and Dissemination, University of York, York YO10 5DD. Telephone 01904 321458; Facsimile: 01904 321035: email: [email protected] Price £12.50 The Centre for Reviews and Dissemination is funded by the NHS Executive and the Health Departments of Wales and Northern Ireland. The views expressed in this publication are those of the authors and not necessarily those of the NHS Executive or the Health Departments of Wales or Northern Ireland. Printed by York Publishing Services Ltd. ii CENTRE FOR REVIEWS AND DISSEMINATION The Centre for Reviews and Dissemination (CRD) is a facility commissioned by the NHS Research and Development Division. Its aim is to identify and review the results of good quality health research and to disseminate actively the findings to key decision makers in the NHS and to consumers of health care services. In this way health care professionals and managers can ensure their practice reflects the best available research evidence. The reviews will cover: the effectiveness of care for particular conditions; the effectiveness of health technologies; and evidence on efficient methods of organising and delivering particular types of health care. Further Information General Enquiries: 01904 321040 Information Service 01904 321078 Publications: 01904 321458 Fax: 01904 321041 Email: [email protected] CRD Reports 1. Which way forward for the care of critically ill children? (1995) £7.50 2. Relationship between volume & quality of health care (1995) £5.00 4. Undertaking systematic reviews of research on effectiveness. 2nd edition (2001) £12.50 5. Ethnicity and health (1996) £12.50 6. Improving access to cost-effectiveness information for health care decision making: the NHS Economic Evaluation Database. (2nd Edition 2001) £9.50 7. A pilot study of ‘Informed Choice’ leaflets on positions in labour (1996) £7.50 8. Concentration and choice in the provision of hospital services (1997) Summary Report £6.00 Part I - Hospital volume and quality of health outcomes £12.50 Part II - Volume and the scope of activity and hospital costs £9.50 Part III - Concentration, patient accessibility and utilisation of service £7.50 Complete set of reports £30.00 9. Preschool vision screening: results of a systematic review (1997) £9.50 10. Systematic review of interventions in the treatment and prevention of obesity (1997) £12.50 11. A systematic review of the effectiveness of interventions for managing childhood nocturnal enuresis (1997) £12.50 13. Screening for ovarian cancer: a systematic review (1998) £12.50 14. Women and secure psychiatric services: a literature review (1999) £12.50 15. Systematic review of the international literature on the epidemiology of mentally disordered offenders (1999) £12.50 16. Scoping review of literature on the health and care of mentally disordered offenders (1999) £12.50 17. Therapeutic community effectiveness: community treatment for people with personality disorders and mentally disordered offenders (1999) £12.50 18. A systematic review of water fluoridation (2000) £20.00 19. The longevity of dental restorations: a systematic review (2001) £20.00 20. Informed choice in maternity care: an evaluation of evidence based leaflets (2001) £20.00 21. Scoping review of the effectiveness of mental health services (2001) £12.50 22. The effectiveness of interventions used in the treatment/management of chronic fatigue syndrome and/or myalgic encephalomyelitis in adults and children (2002) £12.50 23. Access to the online evidence base. A survey of the Northern and Yorkshire Region (2003) £7.50 24. Outcomes measurement in psychiatry (2003) £12.50 25. Scoping review of sabotage and/or tampering in the NHS (2004) £12.50 26. Predictors of delay in seeking medical help in patients with suspected heart attack, and interventions to reduce delay: A systematic review (2004) £12.50 27. A systematic review of cancer waiting time audits (2005) £12.50 28. Systematic review of the clinical and cost effectiveness of ultrasound in screening for developmental dysplasia of the hip in newborns (2005) £12.50 29. Diagnostic value of systematic prostate biopsy methods in the investigation for prostate cancer: a systematic review (2005) £12.50 30. The effects of psychosocial interventions in cancer and heart disease: a review of systematic reviews (2005) £12.50 31. Systematic review of barriers, modifiers and benefits involved in participation in cancer clinical trials (2006) £12.50 32. Systematic review of interventions to increase participation of cancer patients in RCTs £12.50 33. Parenteral oestrogens for prostate cancer: a systematic review of clinical effectiveness and dose response (2006) £12.50 34. Systematic review of the clinical effectiveness of self care support networks in health and social care (2006) £12.50 35. The treatment and management of CFS/ME in adults and children (2007) £12.50 iii ACKNOWLEDGMENTS We would like to thank Ruth Lewis for her help during the development of the protocol and the early stages of this review. We would like to thank the advisory panel for their comments on the protocol and draft report. We would also like to thank all of the authors who provided further information on publications when contacted by us. In particular, we would like to thank Professor J. Allison and Dr L. Lim for providing us with data prior to its publication. iv TABLE OF CONTENTS ACKNOWLEDGMENTS iv LIST OF ABBREVIATIONS vii MEASURES OF DIAGNOSTIC TEST PERFORMANCE ix EXECUTIVE SUMMARY xi 1. BACKGROUND 1 1.1 Burden of disease 1 1.2 The case for screen for colorectal cancer 1 1.3 The use of FOBTs in average risk population screening for CRC 2 1.3.1 Guaiac FOBTs 2 1.3.2 Immunochemical FOBTs 4 2. RESEARCH QUESTIONS 7 3. REVIEW METHODS 9 3.1 Search strategy 9 3.2 Inclusion and exclusion criteria 9 3.2.1 Inclusion criteria for FOBT diagnostic accuracy studies 10 3.2.2 Inclusion criteria for economic evaluations of FOBTs 10 3.3 Data extraction 11 3.3.1 Diagnostic accuracy studies 11 3.3.2 Economic evaluations 11 3.4 Quality assessment 11 3.4.1 Diagnostic accuracy studies 11 3.4.2 Economic evaluations 12 3.5 Synthesis 12 3.5.1 Economic evaluations 13 4. RESULTS OF THE REVIEW 15 4.1 Results of the literature searches 15 4.2 Guaiac FOBTs 15 4.2.1 Quality 17 4.2.2 Diagnosis of all neoplasms using guaiac FOBTs 17 4.2.3 Diagnosis of colorectal cancer using guaiac FOBTs 22 4.2.4 Diagnosis of all ademnomas using guaiac FOBTs 27 4.2.5 Diagnosis of ademnomas 1cm or larger using guaiac FOBTs 29 4.3 Immunochemical FOBTs 36 4.3.1 Quality 36 4.3.2 Diagnosis of all neoplasms using immunochemical FOBTs 37 4.3.3 Diagnosis of colorectal cancer using immunochemical FOBTs 41 4.3.4 Diagnosis of all ademnomas using immunochemical FOBTs 45 4.3.5 Diagnosis of ademnomas 1cm or larger using immunochemical FOBTs 47 4.4 Sequential FOBTs 55 4.5 Comparison of guaiac and immunochemical FOBTs 55 4.5.1 Direct comparisons 55 4.5.2 Indirect comparisons 63 4.6 Adverse events 65 4.7 Economic evaluations 66 4.7.1. Guaiac FOBTs 66 4.7.2 Comparisons between guaiac FOBTs 67 4.7.3 Immunochemical FOBTs 67 4.7.4 Comparison of guaiac and immunochemical FOBTs 68 v 5. DISCUSSION 73 5.1 Review methodology 73 5.2 Key findings of the review 74 5.2.1 Guaiac FOBTs 74 5.2.2 Immunochemical FOBTs 75 5.3 Variability and limitation of he included studies 75 5.4 Economic evaluations 77 5.5 Guaiac or immunochemical FOBT testing? 77 6. CONCLUSIONS 79 6.1 Implications for practice 79 6.2 Implications for research 79 7. REFERENCES 81 8. APPENDICES 123 Appendix A: Advisory panel members 123 Appendix B: FOBT devices 125 Appendix C: Detailed search strategies 129 Appendix D: Checklist with explicit inclusion and exclusion criteria 147 Appendix E: Pre-defined checklist form used to construct the Microsoft Access database 149 Appendix F: QUADAS and details of criteria for scoring studies 151 Appendix G: Details of studies included on this review 155 Appendix H: Details of studies excluded from this review 171 Appendix I: Databases on which included studies were located 181 Appendix J: QUADAS items for each included study 187 Appendix K: Protocol changes 191 Appendix L: CRD structured summaries of the included economic evaluations 193 vi LIST OF ABBREVIATIONS CBA Cost benefit analysis CCT Case-controls study CEA Cost-effectiveness analysis CRC Colorectal cancer CRD Centre for Reviews and Dissemination CUA Cost-utility analysis DALY Disability adjusted life years DC Diagnostic cohort DCC Diagnostic case-control DOR Diagnostic odds ratio FDA Food and Drug Administration FOBT Faecal occult blood test gFOBT Guaiac FOBT GHQ General Health Questionnaire HO (HO II) Haemoccult (Haemoccult) HS Haemoccult Sensa iFOBT Immunochemical
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