Included under terms of UK Non-commercial Government License.
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Headline
Faecal immunochemical testing is likely to be clinically effective and cost-effective in primary care for triaging people presenting with lower abdominal symptoms, but who are at low risk for colorectal cancer.
Abstract
Background:
Colorectal cancer (CRC) is the third most common cancer in the UK. Presenting symptoms that can be associated with CRC usually have another explanation. Faecal immunochemical tests (FITs) detect blood that is not visible to the naked eye and may help to select patients who are likely to benefit from further investigation.
Objectives:
To assess the effectiveness of FITs [OC-Sensor (Eiken Chemical Co./MAST Diagnostics, Tokyo, Japan), HM-JACKarc (Kyowa Medex/Alpha Laboratories Ltd, Tokyo, Japan), FOB Gold (Sentinel/Sysmex, Sentinel Diagnostics, Milan, Italy), RIDASCREEN Hb or RIDASCREEN Hb/Hp complex (R-Biopharm, Darmstadt, Germany)] for primary care triage of people with low-risk symptoms.
Methods:
Twenty-four resources were searched to March 2016. Review methods followed published guidelines. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model. The cost-effectiveness analysis considered long-term costs and quality-adjusted life-years (QALYs) that were associated with different faecal occult blood tests and direct colonoscopy referral. Modelling comprised a diagnostic decision model, a Markov model for long-term costs and QALYs that were associated with CRC treatment and progression, and a Markov model for QALYs that were associated with no CRC.
Results:
We included 10 studies. Using a single sample and 10 µg Hb/g faeces threshold, sensitivity estimates for OC-Sensor [92.1%, 95% confidence interval (CI) 86.9% to 95.3%] and HM-JACKarc (100%, 95% CI 71.5% to 100%) indicated that both may be useful to rule out CRC. Specificity estimates were 85.8% (95% CI 78.3% to 91.0%) and 76.6% (95% CI 72.6% to 80.3%). Triage using FITs could rule out CRC and avoid colonoscopy in approximately 75% of symptomatic patients. Data from our systematic review suggest that 22.5–93% of patients with a positive FIT and no CRC have other significant bowel pathologies. The results of the base-case analysis suggested minimal difference in QALYs between all of the strategies; no triage (referral straight to colonoscopy) is the most expensive. Faecal immunochemical testing was cost-effective (cheaper and more, or only slightly less, effective) compared with no triage. Faecal immunochemical testing was more effective and costly than guaiac faecal occult blood testing, but remained cost-effective at a threshold incremental cost-effectiveness ratio of £30,000. The results of scenario analyses did not differ substantively from the base-case. Results were better for faecal immunochemical testing when accuracy of the guaiac faecal occult blood test (gFOBT) was based on studies that were more representative of the correct population.
Limitations:
Only one included study evaluated faecal immunochemical testing in primary care; however, all of the other studies evaluated faecal immunochemical testing at the point of referral. Further, validation data for the Faecal haemoglobin, Age and Sex Test (FAST) score, which includes faecal immunochemical testing, showed no significant difference in performance between primary and secondary care. There were insufficient data to adequately assess FOB Gold, RIDASCREEN Hb or RIDASCREEN Hb/Hp complex. No study compared FIT assays, or FIT assays versus gFOBT; all of the data included in this assessment refer to the clinical effectiveness of individual FIT methods and not their comparative effectiveness.
Conclusions:
Faecal immunochemical testing is likely to be a clinically effective and cost-effective strategy for triaging people who are presenting, in primary care settings, with lower abdominal symptoms and who are at low risk for CRC. Further research is required to confirm the effectiveness of faecal immunochemical testing in primary care practice and to compare the performance of different FIT assays.
Study registration:
This study is registered as PROSPERO CRD42016037723.
Funding:
The National Institute for Health Research Health Technology Assessment programme.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Objective
- Chapter 2. Background and definition of the decision problem(s)
- Chapter 3. Assessment of clinical effectiveness
- Chapter 4. Assessment of cost-effectiveness
- Chapter 5. Discussion
- Chapter 6. Conclusions
- Acknowledgements
- References
- Appendix 1. Literature search strategies
- Appendix 2. Data extraction tables
- Appendix 3. Assessments of study quality
- Appendix 4. Excluded studies
- Appendix 5. Excluded studies (cost-effectiveness review)
- Appendix 6. Questionnaire and information sent to clinical experts
- Appendix 7. Equations used to estimates probabilities in the diagnostic (decision tree) model
- Appendix 8. Annual survival/mortality rates included in the colorectal cancer Markov model
- Appendix 9. Annual mortality rates included in the healthy population Markov model
- Appendix 10. Technical details about parameter estimation
- Appendix 11. Results (full incremental and intervention versus comparator) of base case and scenario analyses
- Appendix 12. National Institute for Health and Care Excellence guidance relevant to colorectal cancer
- Glossary
- List of abbreviations
About the Series
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 15/17/06. The contractual start date was in February 2016. The draft report began editorial review in October 2016 and was accepted for publication in December 2016. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
none
Last reviewed: October 2016; Accepted: December 2016.
- NLM CatalogRelated NLM Catalog Entries
- Faecal immunochemical tests to triage patients with lower abdominal symptoms for...Faecal immunochemical tests to triage patients with lower abdominal symptoms for suspected colorectal cancer referrals in primary care: a systematic review and cost-effectiveness analysis
- Total hip replacement and surface replacement for the treatment of pain and disa...Total hip replacement and surface replacement for the treatment of pain and disability resulting from end-stage arthritis of the hip (review of technology appraisal guidance 2 and 44): systematic review and economic evaluation
- Can text messages increase safer sex behaviours in young people? Intervention de...Can text messages increase safer sex behaviours in young people? Intervention development and pilot randomised controlled trial
- The 3Mg trial: a randomised controlled trial of intravenous or nebulised magnesi...The 3Mg trial: a randomised controlled trial of intravenous or nebulised magnesium sulphate versus placebo in adults with acute severe asthma
- Urodynamics tests for the diagnosis and management of bladder outlet obstruction...Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT
Your browsing activity is empty.
Activity recording is turned off.
See more...