Title: Developing a strategy for implementation of risk stratification into bowel cancer screening programmes
Funder: Department of Health and Social Care

Abstract: BackgroundColorectal cancer (CRC) is the second leading cause of cancer-related death in the UK. There is good evidence that screening adults in the general population reduces CRC incidence and mortality. Stratified screening, in which the age of first invitation, the choice of test and/or the screening interval are based on additional personal factors, has the potential to improve the efficiency of screening programmes: in a simulated population, when compared with inviting individuals at a fixed age, inviting individuals based on estimated risk is more cost effective, with reduced overall CRC incidence and mortality without increased resource use. Support for stratified screening approaches is also reflected in a number of key recent UK policy documents. However, there is very little research on the public acceptability of changing screening programmes to encompass personalisation or how stratified screening might be implemented. Aims and objectivesThe overall aim is to develop a strategy for implementation of risk stratification within bowel cancer screening programmes. Specific objectives are to: Explore the social and ethical considerations relating to the introduction of risk stratification into CRC screening; Explore views and preferences of individuals concerning the introduction of risk stratification into CRC screening and the acceptability of different strategies; Quantify the relative importance to members of the public of different attributes of risk stratified screening programmes; Quantify the potential impact of incorporating a risk stratified approach on uptake of first invitation to CRC screening; Establish the state-of-the-science and future research and policy requirements for incorporating risk stratification into CRC screening programmes.MethodsThese objectives will be achieved through five work-packages: A community jury study; A semi-structured interview study and online survey with members of the public, informed by the Theoretical Framework of Acceptability; A discrete choice experiment; An online randomised trial including assessment of whether participants would opt to provide baseline risk information and attend screening as outcomes; A scoping review and workshop with key experts in the field.Timelines for deliveryThis research will be conducted over a period of 40 months. Anticipated impact and disseminationOverall, this research will provide key and timely evidence to inform research and policy decisions around the future implementation of risk stratification within CRC screening programmes. The findings will be disseminated in scientific publications, policy briefings and lay summaries. In the short to medium term they will inform the design of a feasibility study and subsequently a large scale randomised trial of stratified screening. They will also provide a framework for risk stratification within other new and existing screening programmes for cancer and other non-communicable diseases. Ultimately, this has the potential to save more lives at a lower cost to society.

Lay abstract: BackgroundBowel cancer is the fourth most common cancer in the UK. One person is diagnosed on average every 15 minutes. It is also the second most common cause of cancer death. Many countries, including the UK, have screening programmes to pick up bowel cancers early. These work, but at the moment people are invited based only on their age and then any further tests are based on their last screening test. Other factors, including sex, body weight, screening history, and information on people's genes, also affect the risk of getting bowel cancer. Using this extra information to decide when people are invited to screening and what further tests they might need may improve the efficiency and effectiveness of programme. For example, those at highest risk might be invited for screening at a younger age and more frequently. This is known as risk stratification.I, and others, are working out the likely benefits and costs of different ways in which the bowel cancer programme could be changed to include risk stratification. However, for the screening programme to work best, people need to understand the programme, believe that the way in which it is organised is fair and appropriate, and choose to attend for screening. No research so far has looked at what people think about including risk stratification within bowel cancer screening programmes.Aim(s)The overall aim is to find ways that risk stratification could be introduced into bowel cancer screening programmes.Specific objectives are to: Explore the social and ethical considerations around introducing risk stratification into bowel cancer screening; Explore the views and preferences of individual members of the public on different ways of introducing risk stratification into bowel cancer screening; Identify what members of the public think are the most important features of a risk-stratified bowel cancer screening programme; Assess the possible effect that inviting people to screening based on an estimate of their risk of developing bowel cancer rather than just their age might have on uptake of screening; Summarise current knowledge and opinions about including risk stratification within bowel cancer screening and identify future research and policy requirements.Design and methods usedThe research includes five studies. In the first study I will hold three community juries. The participants will hear evidence about different ways of changing the screening programme from experts and then feedback their views. In the second study I will speak to members of the public individually about what they think about risk stratification. The third study will be an online survey asking members of the public to choose between different risk stratification options. The fourth will also be an online survey, this time with people divided into five groups to see the effect of different risk stratification options on uptake of screening. Finally, I will find and summarise previous research and policy documents about introducing risk stratification into the bowel cancer screening programme and then hold a workshop with a range of people involved with the programme.Patient and public involvementIn developing this research I held a focus group with 13 members of the public. Two of those have continued to help shape the research. They will remain involved throughout the research.DisseminationThe findings will directly inform policy decisions around including risk stratification into bowel cancer screening programmes. As well as writing scientific articles, we will produce lay summaries and policy briefings to share the findings with the public and policy makers.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.4 POPULATION SCREENING
Health categories: CANCER AND NEOPLASMS