Faecal occult blood testing for population health screening May 2004

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Approach to assessment It has been argued that determining person-centred outcomes (eg, mortality) is the ultimate purpose of performing a test, and that the strongest evidence should come from randomised controlled trials (RCTs). Therefore, the important effects of the range of available faecal occult blood tests (FOBTs) should ideally be measured in a series of person-centred outcomes in RCTs. Level I evidence (ie, a systematic review of all relevant RCTs) shows that people allocated to FOBT screening (Hemoccult, a guaiac test) have a relative risk reduction in colorectal cancer (CRC) mortality of 16 per cent (relative risk 0.84; 95% confidence interval (CI): 0.77, 0.89) (Towler et al 1998). However, it is unlikely that every new FOBT will be included in an RCT, or that patient-centred outcomes will be collected for each test. Therefore, this assessment report focuses on the review of head-to-head studies of FOBTs in ‘average risk’ general population subjects. These studies usually report outcomes such as the number of patients detected with CRC or adenoma(s) rather than CRC mortality. These studies are likely to provide the most robust estimate of the relative performance of commercially available FOBTs for population health screening (Cochrane Methods Group on Systematic Review of Screening and Diagnostic Tests 1996). Review of literature Search strategy The medical literature was searched to identify relevant studies and reviews for the period to February 2004. Searches were conducted via the following primary databases: • Medline 1966 to current • Embase 1980 to current • Econlit 1969 to current. The search terms used included the following: • occult blood; faecal blood; faecal haemoglobin; faecal globin; faecal haem • fobt; hemeoccult; haemoccult; fecatwin; colocare; okokit; hemofec; flexsure; hemeselect; feca-eia; iatrohemcheck; imdiahem; hemochaser; monohaem; hemodia; hemoglobin; annual bowel check; haptoglobin; guaiac; immunochemical test; elisa; inform • mass screening • colorectal neoplasms. Complete details of the literature searches performed using the Medline and Embase databases are presented in Appendix D. 8 Faecal occult blood testing
Searches of the following secondary databases/sites were also performed: • British Columbia Office of Health Technology Assessment • Canadian Coordinating Office for Health Technology Assessment (CCOHTA) • Centre for Health Program Evaluation (Monash University, Australia) • Cochrane Library database • Danish Centre for Evaluation and Health Technology Assessment (DACEHTA) • Health Economics Research Group (Brunel University, UK) • Health Information Research Unit (HIRU) internal database (McMaster University, Canada) • International Standard Randomised Controlled Trial Number (ISRTCN) register (BioMed Central) • National Cancer Control Initiative (NCCI) publication list • National Health and Medical Research Council (NHMRC) Australia publication list • National Health Service Centre for Reviews and Dissemination databases (NHS CRD), including the Database of Abstracts of Reviews and Effects (DARE), the National Health Service Economic Evaluation Database (NHSEED) and the Health Technology Assessment (HTA) database (University of York, UK) • National Information Center on Health Services Research and Health Care Technology, the Health Services Technology Assessment Texts (HSTAT) database (US) • Swedish Council on Technology Assessment in Health Care (SBU) • US Preventative Services Task Force (USPSTF). Other information sources used to gain relevant data included: • market assessments and economic evaluation reports • Therapeutic Goods Administration (TGA) • content experts. Faecal occult blood testing 9
Page 1 and 2: Faecal occult blood testing for pop
Page 3 and 4: Contents Executive summary.........
Page 5 and 6: Tables Table 1 Hierarchy of evidenc
Page 7: Figures Figure 1 Reasons for exclus
Page 10 and 11: BM-Test Colon Albumin. HemeSelect a
Page 12 and 13: The head-to-head studies examining
Page 14 and 15: sensitivity between tests contains
Page 17 and 18: Introduction The Medical Services A
Page 19 and 20: The guaiac FOBTs include brand name
Page 21 and 22: Classification of CRC may be by one
Page 23: Current reimbursement arrangement F
Page 27 and 28: Identified by the search (n = 1214)
Page 29 and 30: Expert advice An advisory panel wit
Page 31 and 32: Trial Trial design Reviewed for eff
Page 33 and 34: eported (Robinson et al 1999). Of t
Page 35 and 36: unacceptable and unethical to subje
Page 37 and 38: Long-term follow-up Randomisation/
Page 39 and 40: Three different methods are used to
Page 41 and 42: • β j is a fixed effect which is
Page 43 and 44: Table 4 Meta-analyses of sensitivit
Page 45 and 46: Relative true positive rate and rel
Page 47 and 48: Table 7 Meta-analyses of relative F
Page 49 and 50: subject to verification bias due to
Page 51 and 52: The literature on FOBT screening fo
Page 53 and 54: Figure 3 Screening pathway used in
Page 55 and 56: Table 10 Prevalence used for indivi
Page 57 and 58: Table 15 and Table 16 outline the c
Page 59 and 60: Relevant sensitivity and specificit
Page 61 and 62: Table 22 Detection rates associated
Page 63 and 64: Following diagnosis of CRC, patient
Page 65 and 66: In the case of Hemoccult Sensa, col
Page 67 and 68: Of the two tests, Hemoccult Sensa d
Page 69 and 70: Table 31 Life-expectancy from the b
Page 71 and 72: • The frequency of screening has
Page 73 and 74: Additionally, for both FOBTs, incre
Page 75 and 76:
screening are higher, the differenc
Page 77 and 78:
Conclusions Safety Faecal occult bl
Page 79 and 80:
The incremental cost per life-year
Page 81:
Summary of outcomes The Medical Ser
Page 84 and 85:
Professor Bryant Stokes Neurologica
Page 86 and 87:
Professor Graeme Young MBBS MD FRAC
Page 88 and 89:
Specificity carcinoma Sensitivity c
Page 90 and 91:
Appendix D Literature searches Medl
Page 92 and 93:
Search history Results 26 hemeselec
Page 94 and 95:
10. Bech K, Kronborg O, Fenger C (1
Page 96 and 97:
33. Foliente RL, Wise GR, Collen MJ
Page 98 and 99:
56. Hart AR, Barone TL, Gay SP, Ing
Page 100 and 101:
79. Kronborg O, Fenger C, Olsen J,
Page 102 and 103:
102. Lynch NM, McHutchison JG, Youn
Page 104 and 105:
125. Nakama H, Fattah A, Zhang B, U
Page 106 and 107:
148. Rasmussen M, Fenger C, Kronbor
Page 108 and 109:
169. Scholefield JH, Moss S, Sufi F
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192. Walker AR, Whynes DK, Hardcast
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Appendix F Positive predictive valu
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Table 42 Meta-analyses of PPV for c
Page 116 and 117:
Table 43 Meta-analyses of PPV for n
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Appendix G Diagnostic odds ratios A
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Figure 10 Summary receiver-operatin
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Appendix I Participation in FOBT sc
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Appendix J Relative cost-effectiven
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Number detected by screening or sym
Page 128 and 129:
Appendix K Sensitivity analysis of
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Abbreviations AACR Australasian Ass
Page 132 and 133:
References Aisawa T, Saito H, Kawag
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Hardcastle JD, Armitage NC, Chamber
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Rae AJ, Cleator IGM (1994), The two
Page 138:
Young GP, St John DJB, Winawer SJ,
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Faecal occult blood testing for population health screening May 2004

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