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

Robert J. C. Steele, Jayne Digby (Lead / Corresponding author), Julie A. Chambers, Ronan E. O'Carroll

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Abstract

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.

Trial registration: The trial is registered on www.isrctn.com on 08/12/2017. Registration no: ISRCTN14254582.

Original languageEnglish
Article number411
Pages (from-to)1-10
Number of pages10
JournalBMC Public Health
Volume19
Issue number1
DOIs
Publication statusPublished - 16 Apr 2019

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Scotland
Colonoscopy
Clinical Protocols
Early Detection of Cancer
Colorectal Neoplasms
Randomized Controlled Trials
Patient Satisfaction
Telephone
Neoplasms
Hemoglobins
Anxiety
Databases
Interviews

Keywords

  • Colorectal cancer
  • Informed choice
  • Bowel screening
  • Colonoscopy
  • Personalised risk information

Cite this

@article{082db6c915584f3da894284553af1555,
title = "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",
abstract = "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.Trial registration: The trial is registered on www.isrctn.com on 08/12/2017. Registration no: ISRCTN14254582.",
keywords = "Colorectal cancer, Informed choice, Bowel screening, Colonoscopy, Personalised risk information",
author = "Steele, {Robert J. C.} and Jayne Digby and Chambers, {Julie A.} and O'Carroll, {Ronan E.}",
note = "This project is funded by the Chief Scientist Office, Scotland, reference number: HIPS/16/44. The study is co-sponsored from University of Dundee and NHS Tayside. TASC (Tayside Medical Science Centre). Ninewells Hospital & Medical School, George Pirie Way, Dundee, DD1 9SY.",
year = "2019",
month = "4",
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doi = "10.1186/s12889-019-6734-0",
language = "English",
volume = "19",
pages = "1--10",
journal = "BMC Public Health",
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T1 - 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

T2 - study protocol

AU - Steele, Robert J. C.

AU - Digby, Jayne

AU - Chambers, Julie A.

AU - O'Carroll, Ronan E.

N1 - This project is funded by the Chief Scientist Office, Scotland, reference number: HIPS/16/44. The study is co-sponsored from University of Dundee and NHS Tayside. TASC (Tayside Medical Science Centre). Ninewells Hospital & Medical School, George Pirie Way, Dundee, DD1 9SY.

PY - 2019/4/16

Y1 - 2019/4/16

N2 - 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.Trial registration: The trial is registered on www.isrctn.com on 08/12/2017. Registration no: ISRCTN14254582.

AB - 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.Trial registration: The trial is registered on www.isrctn.com on 08/12/2017. Registration no: ISRCTN14254582.

KW - Colorectal cancer

KW - Informed choice

KW - Bowel screening

KW - Colonoscopy

KW - Personalised risk information

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DO - 10.1186/s12889-019-6734-0

M3 - Article

C2 - 30991987

VL - 19

SP - 1

EP - 10

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

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