Faecal occult blood testing for population health screening May 2004

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Reference standard It is mandatory that any positive FOBT be investigated by an appropriate diagnostic procedure. The ‘gold-standard’ diagnostic procedure and the procedure of choice for this investigation is colonoscopy. If the colonoscopy is ‘incomplete’, then a DCBE is generally used to ensure complete visualisation of the colon (NHMRC 1999). A DCBE plus flexible sigmoidoscopy may replace the colonoscopy if there are difficulties with local availability or expertise, or if the patient prefers (NHMRC 1999). Comparator Since this report focuses on the relative effectiveness of different commercially available FOBTs and not the absolute effectiveness of these tests, the comparators identified for this evaluation are the other FOBTs that have been or are currently commercially available. Marketing status of the technology The guaiac FOBTs include brand names such as: Hemoccult (Beckman Coulter Inc, USA), Hemoccult Sensa (Beckman Coulter Inc, USA), Hemo FEC (Roche Diagnostics, Switzerland), Coloscreen (Helena Laboratories, USA), Fecatest (Nordic Products, Scandinavia) and Shionogi B (Shionogi Pharmaceutical Co, Japan). SmithKline and French Laboratories first produced the Hemoccult brand in 1970, and the currently marketed version of this product is Hemoccult II, produced by Beckman Coulter Inc. The two versions of this test differ only with regard to their configuration (Mandel et al 1989), therefore this document will refer to both versions simply as Hemoccult, without differentiation. Hemoccult Sensa was produced in 1982 by the same company as an enhanced Hemoccult product and is currently marketed as Hemoccult II Sensa. Beckman Coulter Inc. has also recently marketed the Hemoccult II Sensa elite FOBT. Fecatest does not appear to be currently commercially available. The immunochemical FOBTs include brand names such as: HemeSelect, Immudia- HemSp, Bayer Detect and Magstream HemSp (Fujirebio Inc, Japan); FlexSure OBT (Beckman Coulter Inc., USA); Quicktest (Laboratory Diagnostics, Australia); DIMA FOB-10 (Asquith Laboratories, Australia); !nSure (Enterix Inc., USA); !nForm (Enterix P/L, Australia) and BM-Test Colon Albumin (Boehringer Mannheim, Germany). Immudia-Hem Sp was originally developed and marketed in Japan. HemeSelect (discontinued) is the international equivalent of Immudia-Hem Sp (Young 1998). FlexSure OBT was previously available commercially; however, sales have been discontinued. BM-Test Colon Albumin is now produced by Roche Diagnostics. The two-tiered FOBT, Fecatwin Sensitive/Feca EIA (Nordic Products) does not appear to be currently commercially available. 6 Faecal occult blood testing
Current reimbursement arrangement FOBTs are currently reimbursed on the Medicare Benefits Scheme (MBS). The current wording of the listing of FOBTs on the MBS for item number 66764 is: “Examination for faecal occult blood (including tests for haemoglobin and its derivatives in the faeces) by: (a) an immunological method; and (b) a chemical method (except reagent strip or dip stick); with a maximum of 3 examinations on specimens collected on separate days in a 28-day period - 1 examination by both methods.” Item numbers 66767 and 66770 cover two and three examinations (respectively) by both methods described in item 66764, performed on separately collected and identified specimens. The current wording for item number 73809 is: “Chemical tests for occult blood in faeces by reagent stick, strip, tablet or similar method.” Faecal occult blood testing 7
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: Classification of CRC may be by one
Page 25 and 26: Searches of the following secondary
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
Page 118 and 119:
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
Page 134 and 135:
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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