Original Article
Deprivation and faecal haemoglobin: implications for bowel cancer screening
J Med Screen 2014, Vol. 21(2) 95–97 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0969141314535388 msc.sagepub.com
Jayne Digby1, Paula J McDonald2, Judith A Strachan2, Gillian Libby1, Robert JC Steele3 and Callum G Fraser4
Abstract Objective: To investigate the relationship between deprivation and faecal haemoglobin concentration (f-Hb). Setting: Scottish Bowel Screening Programme. Methods: A total of 66725 men and women, aged 50 to 74, were invited to provide a single sample for a faecal immunochemical test. Deprivation was estimated using the Scottish Index of Multiple Deprivation quintiles: f-Hb was measured (OCSensor, Eiken, Japan) on 38439 participants. The relationship between deprivation quintiles and f-Hb was examined. Results: Median age was 60 years, 53.6% women, with 14.1%, 19.7%, 17.7%, 25.9% and 22.6% in the lowest to the highest deprivation quintiles respectively. No detectable f-Hb was found in 51.9%, ranging from 45.5% in the most deprived up to 56.5% in the least deprived. As deprivation increased, f-Hb increased (p < 0.0001). This trend remained controlling for sex and age (p < 0.001). Participants in the most deprived quintile were more likely to have a f-Hb above a cut-off of 80 mg Hb/g faeces compared with the least deprived, independent of sex and age (adjusted odds ratio 1.70, 95% confidence interval: 1.37 to 2.11). Conclusions: Deprivation and f-Hb are related. This has important implications for selection of cut-off f-Hb for screening programmes, and supports the inclusion of deprivation in risk-scoring systems. Keywords Colorectal cancer, deprivation, faecal haemoglobin, faecal immunochemical test, screening Date received: 22 January 2014; accepted: 22 April 2014
Introduction There is a well-established relationship between deprivation (socio-economic status) and overall cancer incidence, and deprivation has an impact on a number of outcomes in those with colorectal cancer (CRC). Using guaiac-based faecal occult blood tests (gFOBT) in CRC screening programmes, considerable evidence accumulated that deprivation is associated with a high positivity rate, low uptake, and lower acceptance of colonoscopy.1–3 However, gFOBT have many disadvantages4, and faecal immunochemical tests (FIT) for haemoglobin are now considered the best non-invasive tests for CRC screening.5 One of the major merits of quantitative FIT is that faecal haemoglobin concentrations (f-Hb) can be estimated. In our recent assessment of FIT as a first-line test in Scotland6, we documented that use of FIT narrowed current gaps in uptake for sex, age, and deprivation in a bowel cancer screening programme.7 We found that f-Hb increased with age in both sexes, and was higher in men than in women.8 We suggested that these data were vital considerations for screening programme design, more tailored strategies were needed, and f-Hb could be included in
individual risk-scores, along with sex and age. Because deprivation is of considerable relevance to CRC, including its effect on uptake and positivity rates in screening programmes, we investigated the relationship between deprivation and f-Hb.
1 Scottish Bowel Screening Research Unit, University of Dundee, Dundee, Scotland 2 Scottish Bowel Screening Centre Laboratory, Kings Cross, Dundee, Scotland 3 Medical Research Institute, University of Dundee, Dundee, Scotland 4 Centre for Research into Cancer Prevention & Screening, University of Dundee, Dundee, Scotland
Corresponding author: Professor Callum G Fraser, Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, Scotland. Email: [email protected]
96
Journal of Medical Screening 21(2)
Methods The FIT as a first-line test evaluation has been described previously.6 All eligible individuals aged 50 to 74 were sent an invitation pack which contained one specimen collection device (Eiken Chemical Co., Tokyo, Japan). Potential pre-analytical sources of variation were minimized by strict adherence to protocols, as described previously.8 On return to the Laboratory, receipt of a specimen was captured electronically by the Scottish Bowel Screening System through a barcode. Sex and age were derived from the bar-coded CHI number, the 10-digit number used through the health care system in Scotland. Deprivation was categorized from individual postcodes using the Scottish Index of Multiple Deprivation (SIMD), which identifies small area concentrations of multiple deprivation based on income level, employment, health, education, skills and training, housing, geographical access, and crime. Estimation of f-Hb was as described in detail previously in accordance with published guidelines on FIT evaluation reporting (FITTER).9 The barcode labelled specimen collection tubes were assayed on one of two OC-Sensor Diana analyzers (Eiken Chemical Company, Tokyo, Japan). The distributions of f-Hb were calculated overall and for men and women in deprivation quintiles, and a number of properties8 were examined. MedCalc (MedCalc Software, Mariakerke, Belgium) statistical software was used for all calculations. It has been proposed that all FIT data be expressed as mg Hb/g faeces, and a multiplier can be applied to each analytical system:10 for the OC-Sensor Diana, ng Hb/mL buffer data are multiplied by 0.2.
Results Of the 66725 men and women aged 50 to 74 invited, data on SIMD were available on 65704: 17.3%, 21.5%, 17.4%,
24.2%, and 19.6% were in the least to most deprived SIMD quintiles. f-Hb was measured on single samples from 38439 participants, 48.8% men and 51.2% women. Overall, 14.1%, 19.7%, 17.7%, 25.9%, and 22.6% were in the least to the most deprived SIMD quintiles. For men and women, and for all deprivation quintiles, none of the distributions of f-Hb were Gaussian (D’Agostino-Pearson test, p < 0.0001) and the coefficients of skewness and kurtosis were significantly >1 (p < 0.0001). Table 1 shows the distributions of f-Hb for men and women in the deprivation quintiles with conventional 95 % confidence interval (CI). The numbers and percentages given do not represent relative uptakes, but reflect the distribution of deprivation in those who responded to the invitation to participate. No detectable f-Hb was found in 51.9% of participants. A significantly greater proportion of those in the least deprived quintile (56.5%) had no detectable f-Hb than those in the most deprived quintile (45.5%, p < 0.0001). Krusall-Wallis non-parametric analysis of variance (ANOVA) showed that highly statistically significant variation existed in f-Hb in both sexes across deprivation quintiles (p < 0.000001), with f-Hb increasing as deprivation increased. Those in the most and second most deprived quintiles had significantly higher f-Hb than those in each of the three remaining less deprived quintiles (p < 0.001). The positivity rate with the previously used f-Hb cut-off of 400 ng Hb/ml6 would range from 1.96% in the least deprived up to 3.21% in the most deprived overall, and would be higher in men than in women. Logistic regression analysis showed that participants in the most deprived quintile were more likely to have a f-Hb above this cut-off for positivity, compared with the least deprived quintile, independent of gender or age (adjusted odds ratio: 1.70, 95% CI: 1.37 to 2.11). Detection of advanced colorectal neoplasia (defined as cancer or high-risk adenoma (>3 or any >1 cm diameter)) in participants with f-Hb above the cut-off concentration adopted was examined. The odds ratios rose with each
Table 1. Percentiles (with 95 % CI) of faecal haemoglobin concentrations (ng haemoglobin/mL buffer) in men and women according to deprivation quintile. Sex
Deprivation*
n, %
Men Men Men Men Men Women Women Women Women Women
SIMD SIMD SIMD SIMD SIMD SIMD SIMD SIMD SIMD SIMD
2556 3572 3171 4667 3968 2894 4032 3609 5295 4675
1 2 3 4 5 1 2 3 4 5
(14.3) (19.9) (17.7) (26.0) (22.1) (14.1) (19.7) (17.6) (25.8) (22.8)
25.0 %
50.0 %
75.0 %
90.0 %
95.0 %
97.5 %
0 0 0 0 0 0 0 0 0 0
2 2 0 0 0 1 0 0 0 0
16 15 11 9 8 12 10 8 7 6
94 88 64 45 44 58 42 32 30 28
248 257 196 146 146 167 124 96 100 78
604 708 518 481 391 506 364 212 264 202
(0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0)
(2–3) (1–2) (0–1) (0–0) (0–0) (1–2) (0–1) (0–0) (0–0) (0–0)
(14–18) (13–18) (10–13) (8–10) (7–8) (11–13) (9–10) (7–9) (7–8) (6–7)
(74–107) (75–107) (53–75) (40–52) (37–54) (50–74) (36–50) (28–37) (28–33) (25–32)
(197–335) (203–319) (151–237) (119–182) (120–170) (132–207) (102–147) (79–117) (80–117) (65–96)
*Footnote: Deprivation according to the Scottish Index of Multiple Deprivation – SIMD1 ¼ most deprived and SIMD5 ¼ least deprived.
(507–749) (539–998) (361–718) (385–581) (310–482) (358–633) (266–428) (163–293) (197–317) (155–259)
Digby et al. increasing deprivation quintile compared with the least deprived (adjusted odds ratio: 1.48, 95% CI: 0.99–2.22).
Discussion We examined deprivation and f-Hb in a large group of ostensibly asymptomatic people aged 50 to 74. Men had higher concentrations than women in all deprivation quintiles. As degree of deprivation increased, f-Hb overall and in both men and women increased, showing that the mechanisms driving this relationship do not appear to be gender-specific. The relationship between f-Hb and deprivation is reflected by a higher proportion of participants with f-Hb above the cut-off used in our evaluation6 in those in the more deprived groups. As increasing f-Hb relates to severity of colorectal disease, it is important to determine whether increasing deprivation was indeed associated with higher rates of advanced neoplasia detection in our cohort, when controlling for the effects of age and gender, or a greater prevalence of false-positive results were seen in the more deprived groups. Although the trend of increasing odds of advanced neoplasia detection with increasing degree of deprivation did not quite reach significance, it came very close, and this perhaps is sufficient to merit at least the consideration of degree of deprivation for inclusion in risk-scoring systems.
Conclusions A clear relationship exists between degree of deprivation and f-Hb. Although this relationship is likely to be related to lifestyle factors associated with increasing deprivation, for example, poorer diet and increased tobacco smoking, further work is warranted to investigate the mechanisms. With an association existing between deprivation and increased CRC incidence and poorer outcomes, our data further highlight the need to consider adoption of better strategies for setting f-Hb cut-offs. Our findings show that there is potential for deprivation to be included, along with f-Hb, sex, and age, in the risk-scoring systems that are of ever-growing interest. Declaration of interests CGF has consultancy relationships with Immunostics Inc and Mode Diagnostics and has received travel funding from Alpha Labs Ltd: all other authors have no competing interests.
Acknowledgements We thank Iain McElarney of Mast Diagnostics Division, Bootle, Merseyside, UK, for his input into the preparation of material for potential participants and the setting up of the data capture for the automated analytical systems.
97 Funding The additional resources required to undertake the FIT as a firstline test evaluation were provided in part by the Scottish Government Health Directorates. Data analysis was in part supported by a grant from the Chief Scientist Office (grant no. CZH/ 6/4) to establish a Bowel Screening Research Unit. JD was supported by Tenovus Scotland. These sponsors had no role in the collection, analysis, or interpretation of data or in the writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors are independent of the funders in terms of freedom to publish.
Ethics approval Ethics approval was not required for the FIT as a first-line test evaluation. Ethics approval to collect data additional to that generated in the Scottish Bowel Screening Programme was granted by NHS Tayside Ethics Committee and West of Scotland Research Ethics Service. The work was approved by the Scottish Bowel Screening Programme Board and had Caldicott Guardian approval from both NHS Tayside and NHS Ayrshire & Arran.
References 1. Steele RJ, Kostourou I, McClements P, et al. Effect of gender, age and deprivation on key performance indicators in a FOBT-based colorectal screening programme. J Med Screen 2010;17:68–74. 2. Moss SM, Campbell C, Melia J, et al. Performance measures in three rounds of the English bowel cancer screening pilot. Gut 2012;61:101–7. 3. Mansouri D, McMillan DC, Grant Y, et al. The impact of age, sex and socioeconomic deprivation on outcomes in a colorectal cancer screening programme. PLoS One 2013;8:e66063. 4. Fraser CG. A future for faecal haemoglobin measurements in the medical laboratory. Ann Clin Biochem 2012;49:518–26. 5. Imperiale TF. Noninvasive screening tests for colorectal cancer. Dig Dis 2012;30(Suppl 2): 16–26. 6. Steele RJC, McDonald PJ, Digby J, et al. Clinical outcomes using a faecal immunochemical test for haemoglobin as a first-line test in a national programme constrained by colonoscopy capacity. UEGJ 2013;1:198–205. 7. Digby J, McDonald PJ, Strachan JA, et al. Use of a faecal immunochemical test narrows current gaps in uptake for sex, age and deprivation in a bowel cancer screening programme. J Med Screen 2013;20:80–5. 8. McDonald PJ, Strachan JA, Digby J, Steele RJC, Fraser CG. Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer. Clin Chem Lab Med 2012;50:935–40. 9. Fraser CG, Allison JE, Young GP, Halloran SP, Seaman HE. Improving the reporting of evaluations of faecal immunochemical tests for haemoglobin: the FITTER standard and checklist. Eur J Cancer Preven 2014; Feb 27 (Epub ahead of print). 10. Fraser CG, Allison JE, Halloran SP, Young GP. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst 2012;104:810–4.
Copyright of Journal of Medical Screening is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Deprivation and faecal haemoglobin: implications for bowel cancer screening
J Med Screen 2014, Vol. 21(2) 95–97 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0969141314535388 msc.sagepub.com
Jayne Digby1, Paula J McDonald2, Judith A Strachan2, Gillian Libby1, Robert JC Steele3 and Callum G Fraser4
Abstract Objective: To investigate the relationship between deprivation and faecal haemoglobin concentration (f-Hb). Setting: Scottish Bowel Screening Programme. Methods: A total of 66725 men and women, aged 50 to 74, were invited to provide a single sample for a faecal immunochemical test. Deprivation was estimated using the Scottish Index of Multiple Deprivation quintiles: f-Hb was measured (OCSensor, Eiken, Japan) on 38439 participants. The relationship between deprivation quintiles and f-Hb was examined. Results: Median age was 60 years, 53.6% women, with 14.1%, 19.7%, 17.7%, 25.9% and 22.6% in the lowest to the highest deprivation quintiles respectively. No detectable f-Hb was found in 51.9%, ranging from 45.5% in the most deprived up to 56.5% in the least deprived. As deprivation increased, f-Hb increased (p < 0.0001). This trend remained controlling for sex and age (p < 0.001). Participants in the most deprived quintile were more likely to have a f-Hb above a cut-off of 80 mg Hb/g faeces compared with the least deprived, independent of sex and age (adjusted odds ratio 1.70, 95% confidence interval: 1.37 to 2.11). Conclusions: Deprivation and f-Hb are related. This has important implications for selection of cut-off f-Hb for screening programmes, and supports the inclusion of deprivation in risk-scoring systems. Keywords Colorectal cancer, deprivation, faecal haemoglobin, faecal immunochemical test, screening Date received: 22 January 2014; accepted: 22 April 2014
Introduction There is a well-established relationship between deprivation (socio-economic status) and overall cancer incidence, and deprivation has an impact on a number of outcomes in those with colorectal cancer (CRC). Using guaiac-based faecal occult blood tests (gFOBT) in CRC screening programmes, considerable evidence accumulated that deprivation is associated with a high positivity rate, low uptake, and lower acceptance of colonoscopy.1–3 However, gFOBT have many disadvantages4, and faecal immunochemical tests (FIT) for haemoglobin are now considered the best non-invasive tests for CRC screening.5 One of the major merits of quantitative FIT is that faecal haemoglobin concentrations (f-Hb) can be estimated. In our recent assessment of FIT as a first-line test in Scotland6, we documented that use of FIT narrowed current gaps in uptake for sex, age, and deprivation in a bowel cancer screening programme.7 We found that f-Hb increased with age in both sexes, and was higher in men than in women.8 We suggested that these data were vital considerations for screening programme design, more tailored strategies were needed, and f-Hb could be included in
individual risk-scores, along with sex and age. Because deprivation is of considerable relevance to CRC, including its effect on uptake and positivity rates in screening programmes, we investigated the relationship between deprivation and f-Hb.
1 Scottish Bowel Screening Research Unit, University of Dundee, Dundee, Scotland 2 Scottish Bowel Screening Centre Laboratory, Kings Cross, Dundee, Scotland 3 Medical Research Institute, University of Dundee, Dundee, Scotland 4 Centre for Research into Cancer Prevention & Screening, University of Dundee, Dundee, Scotland
Corresponding author: Professor Callum G Fraser, Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, Scotland. Email: [email protected]
96
Journal of Medical Screening 21(2)
Methods The FIT as a first-line test evaluation has been described previously.6 All eligible individuals aged 50 to 74 were sent an invitation pack which contained one specimen collection device (Eiken Chemical Co., Tokyo, Japan). Potential pre-analytical sources of variation were minimized by strict adherence to protocols, as described previously.8 On return to the Laboratory, receipt of a specimen was captured electronically by the Scottish Bowel Screening System through a barcode. Sex and age were derived from the bar-coded CHI number, the 10-digit number used through the health care system in Scotland. Deprivation was categorized from individual postcodes using the Scottish Index of Multiple Deprivation (SIMD), which identifies small area concentrations of multiple deprivation based on income level, employment, health, education, skills and training, housing, geographical access, and crime. Estimation of f-Hb was as described in detail previously in accordance with published guidelines on FIT evaluation reporting (FITTER).9 The barcode labelled specimen collection tubes were assayed on one of two OC-Sensor Diana analyzers (Eiken Chemical Company, Tokyo, Japan). The distributions of f-Hb were calculated overall and for men and women in deprivation quintiles, and a number of properties8 were examined. MedCalc (MedCalc Software, Mariakerke, Belgium) statistical software was used for all calculations. It has been proposed that all FIT data be expressed as mg Hb/g faeces, and a multiplier can be applied to each analytical system:10 for the OC-Sensor Diana, ng Hb/mL buffer data are multiplied by 0.2.
Results Of the 66725 men and women aged 50 to 74 invited, data on SIMD were available on 65704: 17.3%, 21.5%, 17.4%,
24.2%, and 19.6% were in the least to most deprived SIMD quintiles. f-Hb was measured on single samples from 38439 participants, 48.8% men and 51.2% women. Overall, 14.1%, 19.7%, 17.7%, 25.9%, and 22.6% were in the least to the most deprived SIMD quintiles. For men and women, and for all deprivation quintiles, none of the distributions of f-Hb were Gaussian (D’Agostino-Pearson test, p < 0.0001) and the coefficients of skewness and kurtosis were significantly >1 (p < 0.0001). Table 1 shows the distributions of f-Hb for men and women in the deprivation quintiles with conventional 95 % confidence interval (CI). The numbers and percentages given do not represent relative uptakes, but reflect the distribution of deprivation in those who responded to the invitation to participate. No detectable f-Hb was found in 51.9% of participants. A significantly greater proportion of those in the least deprived quintile (56.5%) had no detectable f-Hb than those in the most deprived quintile (45.5%, p < 0.0001). Krusall-Wallis non-parametric analysis of variance (ANOVA) showed that highly statistically significant variation existed in f-Hb in both sexes across deprivation quintiles (p < 0.000001), with f-Hb increasing as deprivation increased. Those in the most and second most deprived quintiles had significantly higher f-Hb than those in each of the three remaining less deprived quintiles (p < 0.001). The positivity rate with the previously used f-Hb cut-off of 400 ng Hb/ml6 would range from 1.96% in the least deprived up to 3.21% in the most deprived overall, and would be higher in men than in women. Logistic regression analysis showed that participants in the most deprived quintile were more likely to have a f-Hb above this cut-off for positivity, compared with the least deprived quintile, independent of gender or age (adjusted odds ratio: 1.70, 95% CI: 1.37 to 2.11). Detection of advanced colorectal neoplasia (defined as cancer or high-risk adenoma (>3 or any >1 cm diameter)) in participants with f-Hb above the cut-off concentration adopted was examined. The odds ratios rose with each
Table 1. Percentiles (with 95 % CI) of faecal haemoglobin concentrations (ng haemoglobin/mL buffer) in men and women according to deprivation quintile. Sex
Deprivation*
n, %
Men Men Men Men Men Women Women Women Women Women
SIMD SIMD SIMD SIMD SIMD SIMD SIMD SIMD SIMD SIMD
2556 3572 3171 4667 3968 2894 4032 3609 5295 4675
1 2 3 4 5 1 2 3 4 5
(14.3) (19.9) (17.7) (26.0) (22.1) (14.1) (19.7) (17.6) (25.8) (22.8)
25.0 %
50.0 %
75.0 %
90.0 %
95.0 %
97.5 %
0 0 0 0 0 0 0 0 0 0
2 2 0 0 0 1 0 0 0 0
16 15 11 9 8 12 10 8 7 6
94 88 64 45 44 58 42 32 30 28
248 257 196 146 146 167 124 96 100 78
604 708 518 481 391 506 364 212 264 202
(0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0) (0–0)
(2–3) (1–2) (0–1) (0–0) (0–0) (1–2) (0–1) (0–0) (0–0) (0–0)
(14–18) (13–18) (10–13) (8–10) (7–8) (11–13) (9–10) (7–9) (7–8) (6–7)
(74–107) (75–107) (53–75) (40–52) (37–54) (50–74) (36–50) (28–37) (28–33) (25–32)
(197–335) (203–319) (151–237) (119–182) (120–170) (132–207) (102–147) (79–117) (80–117) (65–96)
*Footnote: Deprivation according to the Scottish Index of Multiple Deprivation – SIMD1 ¼ most deprived and SIMD5 ¼ least deprived.
(507–749) (539–998) (361–718) (385–581) (310–482) (358–633) (266–428) (163–293) (197–317) (155–259)
Digby et al. increasing deprivation quintile compared with the least deprived (adjusted odds ratio: 1.48, 95% CI: 0.99–2.22).
Discussion We examined deprivation and f-Hb in a large group of ostensibly asymptomatic people aged 50 to 74. Men had higher concentrations than women in all deprivation quintiles. As degree of deprivation increased, f-Hb overall and in both men and women increased, showing that the mechanisms driving this relationship do not appear to be gender-specific. The relationship between f-Hb and deprivation is reflected by a higher proportion of participants with f-Hb above the cut-off used in our evaluation6 in those in the more deprived groups. As increasing f-Hb relates to severity of colorectal disease, it is important to determine whether increasing deprivation was indeed associated with higher rates of advanced neoplasia detection in our cohort, when controlling for the effects of age and gender, or a greater prevalence of false-positive results were seen in the more deprived groups. Although the trend of increasing odds of advanced neoplasia detection with increasing degree of deprivation did not quite reach significance, it came very close, and this perhaps is sufficient to merit at least the consideration of degree of deprivation for inclusion in risk-scoring systems.
Conclusions A clear relationship exists between degree of deprivation and f-Hb. Although this relationship is likely to be related to lifestyle factors associated with increasing deprivation, for example, poorer diet and increased tobacco smoking, further work is warranted to investigate the mechanisms. With an association existing between deprivation and increased CRC incidence and poorer outcomes, our data further highlight the need to consider adoption of better strategies for setting f-Hb cut-offs. Our findings show that there is potential for deprivation to be included, along with f-Hb, sex, and age, in the risk-scoring systems that are of ever-growing interest. Declaration of interests CGF has consultancy relationships with Immunostics Inc and Mode Diagnostics and has received travel funding from Alpha Labs Ltd: all other authors have no competing interests.
Acknowledgements We thank Iain McElarney of Mast Diagnostics Division, Bootle, Merseyside, UK, for his input into the preparation of material for potential participants and the setting up of the data capture for the automated analytical systems.
97 Funding The additional resources required to undertake the FIT as a firstline test evaluation were provided in part by the Scottish Government Health Directorates. Data analysis was in part supported by a grant from the Chief Scientist Office (grant no. CZH/ 6/4) to establish a Bowel Screening Research Unit. JD was supported by Tenovus Scotland. These sponsors had no role in the collection, analysis, or interpretation of data or in the writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors are independent of the funders in terms of freedom to publish.
Ethics approval Ethics approval was not required for the FIT as a first-line test evaluation. Ethics approval to collect data additional to that generated in the Scottish Bowel Screening Programme was granted by NHS Tayside Ethics Committee and West of Scotland Research Ethics Service. The work was approved by the Scottish Bowel Screening Programme Board and had Caldicott Guardian approval from both NHS Tayside and NHS Ayrshire & Arran.
References 1. Steele RJ, Kostourou I, McClements P, et al. Effect of gender, age and deprivation on key performance indicators in a FOBT-based colorectal screening programme. J Med Screen 2010;17:68–74. 2. Moss SM, Campbell C, Melia J, et al. Performance measures in three rounds of the English bowel cancer screening pilot. Gut 2012;61:101–7. 3. Mansouri D, McMillan DC, Grant Y, et al. The impact of age, sex and socioeconomic deprivation on outcomes in a colorectal cancer screening programme. PLoS One 2013;8:e66063. 4. Fraser CG. A future for faecal haemoglobin measurements in the medical laboratory. Ann Clin Biochem 2012;49:518–26. 5. Imperiale TF. Noninvasive screening tests for colorectal cancer. Dig Dis 2012;30(Suppl 2): 16–26. 6. Steele RJC, McDonald PJ, Digby J, et al. Clinical outcomes using a faecal immunochemical test for haemoglobin as a first-line test in a national programme constrained by colonoscopy capacity. UEGJ 2013;1:198–205. 7. Digby J, McDonald PJ, Strachan JA, et al. Use of a faecal immunochemical test narrows current gaps in uptake for sex, age and deprivation in a bowel cancer screening programme. J Med Screen 2013;20:80–5. 8. McDonald PJ, Strachan JA, Digby J, Steele RJC, Fraser CG. Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer. Clin Chem Lab Med 2012;50:935–40. 9. Fraser CG, Allison JE, Young GP, Halloran SP, Seaman HE. Improving the reporting of evaluations of faecal immunochemical tests for haemoglobin: the FITTER standard and checklist. Eur J Cancer Preven 2014; Feb 27 (Epub ahead of print). 10. Fraser CG, Allison JE, Halloran SP, Young GP. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst 2012;104:810–4.
Copyright of Journal of Medical Screening is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
