The impact of personalised risk information compared to a positive/negative result on informed choice and intention to undergo colonoscopy following colorectal Cancer screening in Scotland (PERICCS) - a randomised controlled trial:study protocol

Background In Scotland a new, easier to complete bowel screening test, the Faecal Immunochemical Test (FIT), has been introduced. This test gives more accurate information about an individual’s risk of having colorectal cancer (CRC), based on their age and gender, and could lead to fewer missed cancers compared to the current screening test. However, there is no evidence of the effect on colonoscopy uptake of providing individuals with personalised risk information following a positive FIT test. The objectives of the study are: 1) To develop novel methods of presenting personalised risk information in an easy-to-understand format using infographics with involvement of members of the public 2) To assess the impact of different presentations of risk information on informed choice and intention to take up an offer of colonoscopy after FIT 3) To assess participants’ responses to receiving personal risk information (knowledge, attitudes to screening/risk, emotional responses including anxiety). Methods Adults (age range 50–74) registered on the Scottish Bowel Screening database will be invited by letter to take part. Consenting participants will be randomised to one of three groups to receive hypothetical information about their risk of cancer, based on age, gender and faecal haemoglobin concentration: 1) personalised risk information in numeric form (e.g. 1 in 100) with use of infographics, 2) personalised information described as ‘highest’, ‘moderate’ or ‘lowest’ risk with use of infographics, and 3) as a ‘positive’ test result, as is current practice. Groups will be compared on informed choice, intention to have a colonoscopy, and satisfaction with their decision. Follow-up semi-structured qualitative interviews will be conducted, by telephone, with a small number of consenting participants (n = 10 per group) to explore the acceptability/readability and any potential negative impact of the risk information, participants’ understanding of risk factors, attitudes to the different scenarios, and reasons for reported intentions. Discussion Proving personalised risk information and allowing patient choice could lead to improved detection of CRC and increase patient satisfaction by facilitating informed choice over when/whether to undergo further invasive screening. However, we need to determine whether/how informed choice can be achieved and assess the potential impact on the colonoscopy service

Faecal haemoglobin can define risk of colorectal neoplasia at surveillance colonoscopy in patients at increased risk of colorectal cancer.

Background: Quantitative faecal immunochemical tests measure faecal haemoglobin concentration (f-Hb), which increases in the presence of colorectal neoplasia.Objective: We examined the diagnostic accuracy of faecal immunochemical test (FIT)in patients at increased risk of colorectal cancer (CRC) attending for surveillance colonoscopy as per national guidelines.Methods: A total of 1103 consecutive patients were prospectively invited to complete a FIT before their scheduled colonoscopy in two university hospitals in 2014– 2016. F-Hb was analysed on an OC-Sensor io automated analyser (Eiken Chemical Co., Ltd, Tokyo, Japan) with a limit of detection of 2 µg Hb/g faeces. The diagnostic accuracy of f-Hb for CRC and higher-risk adenoma was examined.Results: A total of 643 patients returned a faecal test. After excluding 4 patients with known inflammatory bowel disease, 639 (57.9%) remained in the study: age range: 25–90 years (median: 64 years, interquartile range (IQR): 55–71): 54.6% male. Of 593 patients who also completed colonoscopy, 41 (6.9%) had advanced neoplasia (4 CRC, 37 higher-risk adenoma). Of the 238 patients (40.1%) who had detectable f-Hb, 31 (13.0%) had advanced neoplasia (2 CRC, 29 higher-risk adenoma) compared with 10 (2.8%) in those with undetectable f-Hb (2 CRC, 8 higher-risk adenoma). Detectable f-Hb gave negative predictive values of 99.4% for CRC and 97.2% for CRC plus higher-risk adenoma.Conclusion: In patients at increased risk of CRC under colonoscopy surveillance, a test measuring faecal haemoglobin can provide an objective estimate of the risk of advanced neoplasia, and could enable tailored scheduling of colonoscopy.</p

Appraisal of the faecal haemoglobin, age and sex test (FAST) score in assessment of patients with lower bowel symptoms:an observational study

Background: Many patients present in primary care with lower bowel symptoms, but significant bowel disease (SBD), comprising colorectal cancer (CRC), advanced adenoma (AA), or inflammatory bowel disease (IBD), is uncommon. Quantitative faecal immunochemical tests for haemoglobin (FIT), which examine faecal haemoglobin concentrations (f-Hb), assist in deciding who would benefit from colonoscopy. Incorporation of additional variables in an individual risk-score might improve this approach. We investigated if the published f-Hb, age and sex test score (FAST score) added value.Methods: Data from the first year of routine use of FIT in primary care in one NHS Board in Scotland were examined: f-Hb was estimated using one HM-JACKarc FIT system (Kyowa Medex Co., Ltd., Tokyo, Japan) with a cut-off for positivity ≥10 μg Hb/g faeces. 5660 specimens were received for analysis in the first year. 4072 patients were referred to secondary care: 2881 (70.6%) of these had returned a FIT specimen. Of those referred, 1447 had colonoscopy data as well as the f-Hb result (group A): 2521 patients, also with f-Hb, were not immediately referred (group B). The FAST score was assessed in both groups.Results: 1196 (41.7%) of patients who returned a specimen for FIT analysis had f-Hb ≥10 μg Hb/g faeces. In group A, 252 of 296 (85.1%) with SBD had f-Hb &gt; 10 μg Hb/g faeces, as did 528 of 1151 (45.8%) without SBD. Using a FAST score &gt; 2.12, which gives high clinical sensitivity for CRC, only 1143 would have been referred for colonoscopy (21.0% reduction in demand): 286 of 296 (96.6%) with SBD had a positive FAST score, as did 857 of 1151 (74.5%) without SBD. However, one CRC, five AA and four IBD would have been missed. In group B, although 95.2% had f-Hb &lt; 10 μg Hb/g faeces, 1371 (53.7%) had FAST score ≥ 2.12: clinical rationale led to only 122 of group B completing subsequent bowel investigations: a FAST score &gt; 2.12 was found in 13 of 15 (86.7%) with SBD.Conclusions: The performance characteristics of the FAST score did not seem to enhance the utility of f-Hb alone. Locally-derived formulae might confer desired benefits.</p

Impact of introducing a faecal immunochemical test (FIT) for haemoglobin into primary care on the outcome of patients with new bowel symptoms:A prospective cohort study

Objective To determine whether a faecal immunochemical test (FIT) for faecal haemoglobin concentration (f-Hb) can be safely implemented in primary care as a rule-out test for significant bowel disease (SBD) (colorectal cancer (CRC), higher risk adenoma (HRA) and inflammatory bowel disease (IBD)) when used as an adjunct to the clinical assessment of new bowel symptoms. Design Single-centre prospective cohort study of all patients who attended primary care and submitted a FIT in the first calendar year of the service beginning December 2015. f-Hb was estimated using HM-JACKarc (Kyowa Medex) with a clinical cut-off of ≥10 μg Hb/g faeces. Incident cases of CRC were verified via anonymised record linkage to the Scottish Cancer Registry. Results 5422 patients submitted 5660 FIT specimens, of which 5372 were analysed (positivity: 21.9%). 2848 patients were referred immediately to secondary care and three with f-Hb &lt;10 μg/g presented acutely within days with obstructing CRC. 1447 completed colonoscopy in whom overall prevalence of SBD was 20.5% (95 CRC (6.6%), 133 HRA (9.2%) and 68 IBD (4.7%)); 6.6% in patients with f-Hb &lt;10 μg/g vs 32.3% in patients with f-Hb ≥10 μg/g. One CRC was detected at CT colonoscopy. 2521 patients were not immediately referred (95.3% had f-Hb &lt;10 μg/g) of which four (0.2%) later developed CRC. Record linkage identified no additional CRC cases within a follow-up period of 23-35 months. Conclusion In primary care, measurement of f-Hb, in conjunction with clinical assessment, can safely and objectively determine a patient's risk of SBD.</p

Faecal haemoglobin concentration is related to detection of advanced colorectal neoplasia in the next screening round

Objective: To examine associations between faecal haemoglobin concentrations below the cut-off used in colorectal cancer screening and outcomes in the next screening round.Methods: In the Scottish Bowel Screening Programme, faecal haemoglobin concentrations and diagnostic outcomes were investigated for participants with a negative result (faecal haemoglobin concentrations &lt; 80.0 µg Hb/g faeces), followed by a positive result within two years.Results: Of 37,780 participants with negative results, at the next screening round, 556 (1.5%) screened positive and 30,293 (80.2%) negative. Initial median faecal haemoglobin concentrations (2.1 µg Hb/g faeces, IQR: 0.0-13.2) were higher in those with subsequent positive results than those with subsequent negative results (0.0 µg Hb/g faeces, IQR: 0.0-1.4; p &lt; 0.0001). Using faecal haemoglobin concentrations 0.0-19.9 µg Hb/g faeces as reference, logistic regression analysis showed high adjusted odds ratios for advanced neoplasia (advanced neoplasia: colorectal cancer or higher risk adenoma) detection at the next round of 14.3 (95% CI: 8.9-23.1) in those with initial faecal haemoglobin concentrations 20.0-39.9 µg Hb/g faeces, and 38.0 (95% CI: 20.2-71.2) with 60.0-79.9 µg Hb/g faeces.Conclusions: A higher proportion of participants with faecal haemoglobin concentrations of ≥ 20 µg Hb/g faeces had advanced neoplasia detected at the next round than participants with lower faecal haemoglobin concentrations. Although most relevant when using high faecal haemoglobin concentrations cut-offs, studies of faecal haemoglobin concentrations and outcomes over screening rounds may provide strategies to direct available colonoscopy towards those at highest risk.</p

Do other variables add value to assessment of the risk of colorectal disease using faecal immunochemical tests for haemoglobin?

Background: Faecal immunochemical tests for haemoglobin have been recommended to assist in assessment of patients presenting in primary care with lower bowel symptoms. The aim was to assess if, and which, additional variables might enhance this use of faecal immunochemical tests.Methods: Faecal immunochemical test analysis has been a NHS Tayside investigation since December 2015. During the first year, 993 patients attending colonoscopy were invited to complete a detailed questionnaire on demographic background, symptoms, smoking status, alcohol use, dietary fibre, red and processed meat intake, physical activity, sitting time, dietary supplement use, family history of colorectal cancer, adenoma, inflammatory bowel disease and diabetes. Significant bowel disease was classified as colorectal cancer, advanced adenoma or inflammatory bowel disease.Results: A total of 470 (47.3%) invitees agreed to complete the questionnaire and 408 (41.1%) did. Unadjusted odds ratios for the presence of significant bowel disease compared with undetectable faecal haemoglobin increased with increasing faecal haemoglobin and for faecal haemoglobin 10–49, 50–199, 200–399 and ⩾400 μg Hb/g faeces were 0.95 (95% CI: 0.16–5.63), 2.47 (0.55–1.03), 6.30 (1.08–36.65) and 18.90 (4.22–84.62), respectively. Rectal bleeding and family history of polyps were the only other variables with statistically significant (P &lt; 0.05) odds ratios greater than 1.00, being 1.88 (1.13–3.17) and 2.93 (1.23–6.95), respectively. Odds ratios adjusted for all other variables showed similar associations, but only faecal haemoglobin and family history of polyps had significant associations.Conclusions: Faecal haemoglobin is the most important factor to be considered when deciding which patients presenting in primary care with lower bowel symptoms would benefit most from referral for colonoscopy.</p

Interval cancers using a quantitative faecal immunochemical test (FIT) for haemoglobin when colonoscopy capacity is limited

Objectives: Quantitative faecal immunochemical tests (FIT) for faecal haemoglobin (f-Hb) in colorectal cancer (CRC) screening pose challenges when colonoscopy is limited. For low positivity rates, high f-Hb concentration cut-offs are required, but little is known about interval cancer (IC) proportions using FIT. We assessed IC proportions using an 80 µg Hb/g cut-off.Methods: In two NHS Boards in the Scottish Bowel Screening Programme, f-Hb was estimated for 30,893 participants aged 50-75, of whom 753 participants with f-Hb ≥ 80 µg Hb/g were referred for colonoscopy. ICs, defined as CRC within two years of a negative result, were identified from the Scottish Cancer Registry.Results: There were 31 ICs and 30 screen-detected (SD) CRCs, an IC proportion of 50.8% (48.4% for men, 53.3% for women). CRC site distribution was similar between ICs and SD, but ICs were later stage (46.7% and 33.3%, Dukes' stages C and D, respectively). Of 31 ICs, 23 had f-Hb &lt; 10 µg Hb/g, including six with undetectable f-Hb. A f-Hb cut-off of 10 µg Hb/g would have raised the positivity rate from 2.4% to 9.4%, increased colonoscopy requirement from 753 to 2147, and reduced the IC proportion to 38.3%.Conclusions: The IC proportion was similar to that seen with guaiac-based FOBT. The later stage distribution of ICs highlights the benefits of lower f-Hb cut-offs, but with 19.4% of ICs having undetectable f-Hb, some cancers would have been missed, even with drastic reduction in the f-Hb cut-off.</p

Ugandan pupils as decision makers: freedoms and constraints

The thesis comprises a qualitative study exploring the freedoms and constraints to pupils participating in decisions relating to their education. The context of the study is within rural Uganda and includes an analysis of political, cultural and structural frameworks which may inhibit or enhance pupils from making decisions