Faecal occult blood testing for population health screening May 2004

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© Commonwealth of Australia 2004 ISBN 0 642 82545 9 ISSN (Print) 1443-7120 ISSN (Online) 1443-7139 First printed October 2004 This work is copyright. Apart from any use as permitted under the Copyright Act 1968 no part may be reproduced by any process without written permission from AusInfo. Requests and inquiries concerning reproduction and rights should be directed to the Manager, Legislative Services, AusInfo, GPO Box 1920, Canberra, ACT, 2601. Electronic copies of the report can be obtained from the Medical Service Advisory Committee’s Internet site at: http://www.msac.gov.au/ Hard copies of the report can be obtained from: The Secretary Medical Services Advisory Committee Department of Health and Ageing Mail Drop 107 GPO Box 9848 Canberra ACT 2601 Enquiries about the content of the report should be directed to the above address. The Medical Services Advisory Committee is an independent committee which has been established to provide advice to the Commonwealth Minister for Health and Ageing on the strength of evidence available on new and existing medical technologies and procedures in terms of their safety, effectiveness and costeffectiveness. This advice will help to inform Government decisions about which medical services should attract funding under Medicare. MSAC recommendations do not necessarily reflect the views of all individuals who participated in the MSAC evaluation. This report was prepared by the Medical Services Advisory Committee with the assistance of Mr Lachlan Standfield, Dr Suzanne Dyer, Mr Dominic Tilden, Mr Paul Mernagh and Dr Patrick Fitzgerald from M-TAG Pty Ltd. Publication approval number: 3533
Contents Executive summary................................................................................................. ix Introduction .............................................................................................................1 Background ............................................................................................................ 2 Faecal occult blood testing............................................................................................. 2 Description of the technology and the procedure............................................ 2 Intended purpose .................................................................................................. 3 Clinical need/burden of disease .................................................................................... 4 Incidence of colorectal cancer............................................................................. 5 Mortality due to colorectal cancer....................................................................... 5 Existing procedures......................................................................................................... 5 Reference standard .......................................................................................................... 6 Comparator....................................................................................................................... 6 Marketing status of the technology............................................................................... 6 Current reimbursement arrangement ........................................................................... 7 Approach to assessment .......................................................................................... 8 Review of literature ......................................................................................................... 8 Search strategy ....................................................................................................... 8 Selection criteria................................................................................................... 10 Quality assessment .............................................................................................. 12 Additional searches ............................................................................................. 12 Expert advice.................................................................................................................. 13 Results of assessment .............................................................................................14 Faecal occult blood testing........................................................................................... 14 Available evidence............................................................................................... 14 Is it safe?.......................................................................................................................... 16 Adverse events associated with faecal occult blood tests.............................. 16 Adverse events associated with colonoscopy, sigmoidoscopy and double contrast barium enema.......................................................................... 16 Psychiatric morbidity associated with colorectal cancer screening .............. 17 Safety data reported in the FOBT studies ....................................................... 17 Is it effective? ................................................................................................................. 18 Diagnostic performance..................................................................................... 18 Participation ......................................................................................................... 22 Change in clinical management and clinical outcomes.................................. 22 Results................................................................................................................... 22 Faecal occult blood testing iii
Page 1: Faecal occult blood testing for pop
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 and 24: Current reimbursement arrangement F
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
Page 110 and 111:
192. Walker AR, Whynes DK, Hardcast
Page 112 and 113:
Appendix F Positive predictive valu
Page 114 and 115:
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
Page 120 and 121:
Figure 10 Summary receiver-operatin
Page 122 and 123:
Appendix I Participation in FOBT sc
Page 124 and 125:
Appendix J Relative cost-effectiven
Page 126 and 127:
Number detected by screening or sym
Page 128 and 129:
Appendix K Sensitivity analysis of
Page 130 and 131:
Abbreviations AACR Australasian Ass
Page 132 and 133:
References Aisawa T, Saito H, Kawag
Page 134 and 135:
Hardcastle JD, Armitage NC, Chamber
Page 136 and 137:
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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