Randomized controlled trial: Flexible sigmoidoscopy as an adjunct to faecal occult blood testing in population screening.

OBJECTIVES: Flexible sigmoidoscopy screening at around age 60 can reduce colorectal cancer incidence. Insufficient evidence exists on flexible sigmoidoscopy at age 60 in a population being offered biennial faecal occult blood test screening from age 50. This randomized controlled trial assessed if flexible sigmoidoscopy would be an effective adjunct to faecal occult blood test. METHODS: In the Scottish Bowel Screening Programme between June 2014 and December 2015, 51,769 individuals were randomized to be offered flexible sigmoidoscopy instead of faecal occult blood test at age 60 or to continue faecal occult blood test. Those not accepting flexible sigmoidoscopy and those with normal flexible sigmoidoscopy were offered faecal occult blood test. All with flexible sigmoidoscopy-detected neoplasia or a positive faecal occult blood test result were offered colonoscopy. RESULTS: Overall flexible sigmoidoscopy uptake was 17.8%, higher in men than women, and decreased with increasing deprivation (25.7% in the least to 9.2% in the most deprived quintile). In those who underwent flexible sigmoidoscopy, detection rate for colorectal cancer was 0.13%, for adenoma 7.27%, and for total neoplasia 7.40%. In those who underwent colonoscopy after a positive flexible sigmoidoscopy, detection rate for colorectal cancer was 0.28%, adenoma 8.66%, and total neoplasia 8.83%. On an intention to screen basis, there was no difference in colorectal cancer detection rate between the study and control groups. Adenoma and total neoplasia detection rate were significantly higher in the study group, with odds ratios of 5.95 (95%CI: 4.69-7.56) and 5.10 (95%CI: 4.09-6.35), respectively. CONCLUSIONS: In a single screening round at age 60, there was low uptake and neoplasia detection rate. Flexible sigmoidoscopy detected significantly more neoplasia than faecal occult blood test alone.

Development of an evidence-based brief 'talking' intervention for non-responders to bowel screening for use in primary care: stakeholder interviews.

BACKGROUND: Bowel cancer is the third most common cause of cancer death worldwide. Bowel screening has been shown to reduce mortality and primary care interventions have been successful in increasing uptake of screening. Using evidence-based theory to inform the development of such interventions has been shown to increase their effectiveness. This study aimed to develop and refine a brief evidence-based intervention for eligible individuals whom have not responded to their last bowel screening invitation (non-responders), for opportunistic use by primary care providers during routine consultations. METHODS: The development of a brief intervention involving a conversation between primary care providers and non-responders was informed by a multi-faceted model comprising: research team workshop and meetings to draw on expertise; evidence from the literature regarding barriers to bowel screening and effective strategies to promote informed participation; relevant psychological theory, and intervention development and behaviour change guidance. Qualitative telephone interviews with 1) bowel screening stakeholders and 2) patient non-responders explored views regarding the acceptability of the intervention to help refine its content and process. RESULTS: The intervention provides a theory and evidence-based tool designed to be incorporated within current primary care practice. Bowel screening stakeholders were supportive of the intervention and recognised the importance of the role of primary care. Interviews highlighted the importance of brevity and simplicity to incorporate the intervention into routine clinical care. Non-responders similarly found the intervention acceptable, valuing a holistic approach to their care. Moreover, they expected their primary care provider to encourage participation. CONCLUSIONS: A theory-based brief conversation for use in a primary care consultation was acceptable to bowel screening stakeholders and potential recipients, reflecting a health promoting primary care ethos. Findings indicate that it is appropriate to test the intervention in primary care in a feasibility study.

Is an opportunistic primary care-based intervention for non-responders to bowel screening feasible and acceptable? A mixed-methods feasibility study in Scotland.

OBJECTIVES: We aimed to test whether a brief, opportunistic intervention in general practice was a feasible and acceptable way to engage with bowel screening non-responders. DESIGN: This was a feasibility study testing an intervention which comprised a brief conversation during routine consultation, provision of a patient leaflet and instructions to request a replacement faecal occult blood test kit. A mixed-methods approach to evaluation was adopted. Data were collected from proformas completed after each intervention, from the Bowel Screening Centre database and from questionnaires. Semi-structured interviews were carried out. We used descriptive statistics, content and framework analysis to determine intervention feasibility and acceptability. PARTICIPANTS: Bowel screening non-responders (as defined by the Scottish Bowel Screening Centre) and primary care professionals working in five general practices in Lothian, Scotland. PRIMARY AND SECONDARY OUTCOME MEASURES: Several predefined feasibility parameters were assessed, including numbers of patients engaging in conversation, requesting a replacement kit and returning it, and willingness of primary care professionals to deliver the intervention. RESULTS: The intervention was offered to 258 patients in five general practices: 220 (87.0%) engaged with the intervention, 60 (23.3%) requested a new kit, 22 (8.5%) kits were completed and returned. Interviews and questionnaires suggest that the intervention was feasible, acceptable and consistent with an existing health prevention agenda. Reported challenges referred to work-related pressures, time constraints and practice priorities. CONCLUSIONS: This intervention was acceptable and resulted in a modest increase in non-responders participating in bowel screening, although outlined challenges may affect sustained implementation. The strategy is also aligned with the increasing role of primary care in promoting bowel screening.

Anticipated regret to increase uptake of colorectal cancer screening (ARTICS): A randomised controlled trial.

Screening is important for early detection of colorectal cancer. Our aim was to determine whether a simple anticipated regret (AR) intervention could increase uptake of colorectal cancer screening. A randomised controlled trial of a simple, questionnaire-based AR intervention, delivered alongside existing pre-notification letters, was conducted. A total of 60,000 adults aged 50-74 years from the Scottish National Screening programme were randomised into the following groups: (1) no questionnaire (control), (2) Health Locus of Control questionnaire (HLOC) or (3) HLOC plus AR questionnaire. The primary outcome was return of the guaiac faecal occult blood test (FOBT). The secondary outcomes included intention to return test kit and perceived disgust (ICK). A total of 59,366 people were analysed as allocated (intention-to-treat (ITT)); no overall differences were seen between the treatment groups on FOBT uptake (control: 57.3%, HLOC: 56.9%, AR: 57.4%). In total, 13,645 (34.2%) individuals returned the questionnaires. Analysis of the secondary questionnaire measures showed that AR indirectly affected FOBT uptake via intention, whilst ICK directly affected FOBT uptake over and above intention. The effect of AR on FOBT uptake was also moderated by intention strength: for less-than-strong intenders only, uptake was 4.2% higher in the AR (84.6%) versus the HLOC group (80.4%) (95% CI for difference (2.0, 6.5)). The findings show that psychological concepts including AR and perceived disgust (ICK) are important factors in determining FOBT uptake. However, the AR intervention had no simple effect in the ITT analysis. It can be concluded that, in those with low intentions, exposure to AR may be required to increase FOBT uptake. The current controlled trials are presented at the website www.controlled-trials.com (number: ISRCTN74986452).

Anticipated regret to increase uptake of colorectal cancer screening in Scotland (ARTICS): study protocol for a randomised controlled trial.

BACKGROUND: Colorectal cancer is the second leading cause of cancer deaths in the UK. Screening is key to early detection. The Scottish programme of colorectal cancer screening is running successfully, and involves all adults aged between 50 and 74 years being invited to post back a faecal sample for testing every 2 years. However, screening uptake is sub-optimal: for example rates for the period November 2009 to October 2011 ranged from just 39% for males living in the most deprived areas to 67% for least deprived females. Recent research has shown that asking people to consider the emotional consequences of not participating in screening (anticipated regret) can lead to a significant increase in screening uptake. METHODS/DESIGN: We will test a simple anticipated regret manipulation, in a large randomised controlled trial with 60,000 members of the general public. They will be randomly allocated to one of 3 arms, no questionnaire, control questionnaire or anticipated regret questionnaire. The primary outcome will be screening test kit return. Results will also be examined by demographic variables (age, gender, deprivation) as these are currently related to screening kit return. DISCUSSION: If this anticipated regret intervention leads to a significant increase in colorectal cancer screening kit returns, this would represent a rare example of a theoretically-driven, simple intervention that could result in earlier detection of colorectal cancer and many more lives saved. TRIAL REGISTRATION: Current Controlled trials: ISRCTN74986452.

Clinical outcomes using a faecal immunochemical test for haemoglobin as a first-line test in a national programme constrained by colonoscopy capacity.

INTRODUCTION: Because of their many advantages, faecal immunochemical tests (FIT) are superseding traditional guaiac-based faecal occult blood tests in bowel screening programmes. METHODS: A quantitative FIT was adopted for use in two evaluation National Health Service (NHS) Boards in Scotland using a cut-off faecal haemoglobin concentration chosen to give a positivity rate equivalent to that achieved in the Scottish Bowel Screening Programme. Uptake and clinical outcomes were compared with results obtained contemporaneously in two other similar NHS Boards and before and after the evaluation in the two evaluation NHS Boards. RESULTS: During the evaluation, uptake was 58.5%. This was higher than in the same NHS Boards both before and after the evaluation, higher than in the other two NHS Boards and higher than the 53.7% achieved overall in Scotland. The overall positivity rate was higher in men than in women and increased with age in both genders. Positive predictive values for cancer (4.8%), high-risk adenoma (23.3%), all adenoma (38.2%) and all neoplasia (43.0%) in the two test NHS Boards were similar in all groups. CONCLUSIONS: In summary, this evaluation of the FIT supports the introduction of FIT as a first-line test, even when colonoscopy capacity is limited.

Pre-notification increases uptake of colorectal cancer screening in all demographic groups: a randomized controlled trial.

OBJECTIVES: To assess whether pre-notification is effective in increasing uptake of colorectal cancer screening for all demographic groups. SETTING: Scottish national colorectal cancer screening programme. METHODS: Males and females aged 50-74 years received a faecal occult blood test by post to complete at home. They were randomized to receive in addition: the pre-notification letter, the pre-notification letter + information booklet, or the usual invitation. Overall, 59,953 subjects were included in the trial between 13/04/09 and 29/05/09 and followed to 27/11/09. Pre-notification letters were posted two weeks ahead of the screening test kit. Uptake was defined as the return of a screening test and chi-squared tests compared uptake between the trial arms. Logistic regression assessed the impact of the letter and letter + booklet on uptake independently of gender, age, deprivation and screening round. RESULTS: Uptake was higher with both the letter (59.0%) and the letter + booklet (58.5%) compared with the usual invitation (53.9%, p < 0.0001). This increased uptake was seen for males, females, all age groups and all deprivation categories including least deprived females (letter 69.9%, usual invitation 66.6%) and most deprived males (42.6% vs. 36.1%), the groups with the highest and lowest levels of uptake respectively in the pilot screening rounds conducted prior to the roll out of the programme. Uptake with the pre-notification letter compared with the usual invitation was higher both unadjusted and adjusted for demographic factors (odds ratio 1.24, 95% CI 1.193-1.294). CONCLUSIONS: Pre-notification is an effective method of increasing uptake in colorectal cancer screening for both genders and all age and deprivation groups.