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Published in: BMC Public Health 1/2019

Open Access 01-12-2019 | Colonoscopy | Study protocol

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

Authors: Robert J. C. Steele, Jayne Digby, Julie A. Chambers, Ronan E. O’Carroll

Published in: BMC Public Health | Issue 1/2019

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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.
Literature
1.
go back to reference Edwards AGK, Naik G, Ahmed H, Elwyn GJ, Pickles T, Hood K, et al. Personalised risk communication for informed decision making about taking screening tests. Cochrane database of systematic reviews, issue 2. Art. No.: CD001865, 2013. Edwards AGK, Naik G, Ahmed H, Elwyn GJ, Pickles T, Hood K, et al. Personalised risk communication for informed decision making about taking screening tests. Cochrane database of systematic reviews, issue 2. Art. No.: CD001865, 2013.
2.
go back to reference Trevena L, Irwig L, Barratt A. Randomized trial of a self-administered decision aid for colorectal cancer screening. J Med Screen. 2008;15:76–82.CrossRef Trevena L, Irwig L, Barratt A. Randomized trial of a self-administered decision aid for colorectal cancer screening. J Med Screen. 2008;15:76–82.CrossRef
3.
go back to reference Lee CY. A randomized controlled trial to motivate worksite fecal occult blood testing. Yomsei Med J. 1991;32:131–8. Lee CY. A randomized controlled trial to motivate worksite fecal occult blood testing. Yomsei Med J. 1991;32:131–8.
4.
go back to reference Glanz K, Steffen AD, Taglialatela LA. Effects of colon cancer risk counseling for first-degree relatives. Cancer Epidemiol Biomark Prev. 2007;16:1485–91.CrossRef Glanz K, Steffen AD, Taglialatela LA. Effects of colon cancer risk counseling for first-degree relatives. Cancer Epidemiol Biomark Prev. 2007;16:1485–91.CrossRef
5.
go back to reference Sequist TD, Zaslavsky AM, Colditz GA, Ayanian JZ. Electronic patient messages to promote colorectal cancer screening: a randomized, controlled trial. Arch Intern Med. 2011;171:636–41.CrossRef Sequist TD, Zaslavsky AM, Colditz GA, Ayanian JZ. Electronic patient messages to promote colorectal cancer screening: a randomized, controlled trial. Arch Intern Med. 2011;171:636–41.CrossRef
6.
go back to reference O’Carroll RE, Chambers JA, Brownlee L, Libby G, Steele RJC. Anticipated regret to increase uptake of colorectal cancer screening (ARTICS): a randomised controlled trial. Soc Sci Med. 2015;142:118–27.CrossRef O’Carroll RE, Chambers JA, Brownlee L, Libby G, Steele RJC. Anticipated regret to increase uptake of colorectal cancer screening (ARTICS): a randomised controlled trial. Soc Sci Med. 2015;142:118–27.CrossRef
7.
go back to reference Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, et al. Methods to increase response rates to postal questionnaires. Cochrane Database Syst Rev. 2007;(18, 2):MR000008. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, et al. Methods to increase response rates to postal questionnaires. Cochrane Database Syst Rev. 2007;(18, 2):MR000008.
8.
go back to reference O’Carroll RE, Chambers JA, Dennis M, Sudlow C, Johnston M. Improving adherence to medication in stroke survivors: a pilot randomised controlled trial. Annals Behav Med. 2013;46:358–68.CrossRef O’Carroll RE, Chambers JA, Dennis M, Sudlow C, Johnston M. Improving adherence to medication in stroke survivors: a pilot randomised controlled trial. Annals Behav Med. 2013;46:358–68.CrossRef
9.
go back to reference Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomized controlled trial. BMJ. 2010;341:c5370.CrossRef Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomized controlled trial. BMJ. 2010;341:c5370.CrossRef
10.
go back to reference Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping doctors and patients make sense of health statistics. Psychol Sci Public Interest. 2007;8(2):53–96.CrossRef Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping doctors and patients make sense of health statistics. Psychol Sci Public Interest. 2007;8(2):53–96.CrossRef
11.
go back to reference Royal College of Obstetricians and Gynaecologists. Presenting information on risk. In: Clinical governance advice no. 7. London: RCOG; 2008. Royal College of Obstetricians and Gynaecologists. Presenting information on risk. In: Clinical governance advice no. 7. London: RCOG; 2008.
12.
go back to reference Jepson RG, Hewison J, Thompson AGH, Weller D. How should we measure informed choice? The case of cancer screening. J Med Ethics. 2015;31:192–6.CrossRef Jepson RG, Hewison J, Thompson AGH, Weller D. How should we measure informed choice? The case of cancer screening. J Med Ethics. 2015;31:192–6.CrossRef
13.
go back to reference Digby J, Fraser CJ, Carey FA, McDonald PJ, Strachan JA, Diament RH, et al. Faecal Haemoglobin concentration is related to severity of colorectal neoplasia. J Clin Pathol. 2013;15:415–9.CrossRef Digby J, Fraser CJ, Carey FA, McDonald PJ, Strachan JA, Diament RH, et al. Faecal Haemoglobin concentration is related to severity of colorectal neoplasia. J Clin Pathol. 2013;15:415–9.CrossRef
14.
go back to reference Chambers JA, Callander AS, Grangeret R, O'Carroll RE. Attitudes towards the Faecal occult blood test (FOBT) versus the Faecal immunochemical test (FIT) for colorectal cancer screening: perceived ease of completion and disgust. Colorectal Cancer. 2016;16(1):1–7. Chambers JA, Callander AS, Grangeret R, O'Carroll RE. Attitudes towards the Faecal occult blood test (FOBT) versus the Faecal immunochemical test (FIT) for colorectal cancer screening: perceived ease of completion and disgust. Colorectal Cancer. 2016;16(1):1–7.
15.
go back to reference Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001;4:99–108.CrossRef Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001;4:99–108.CrossRef
16.
go back to reference Michie S, Dormandy E, Marteau TM. Informed choice: understanding knowledge in the context of screening uptake. Pat Educ Counsel. 2003;50:247–53.CrossRef Michie S, Dormandy E, Marteau TM. Informed choice: understanding knowledge in the context of screening uptake. Pat Educ Counsel. 2003;50:247–53.CrossRef
17.
go back to reference O’Connor AM. Validation of a decisional conflict scale. Med Dec Making. 1995;15:25–30.CrossRef O’Connor AM. Validation of a decisional conflict scale. Med Dec Making. 1995;15:25–30.CrossRef
18.
go back to reference Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger state-trait anxiety inventory (STAI). Brit J Clin Psychol. 1992;31:301–6.CrossRef Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger state-trait anxiety inventory (STAI). Brit J Clin Psychol. 1992;31:301–6.CrossRef
19.
go back to reference Musselwhite K, Cuff L, McGregor L, King KM. The telephone interview is an effective method of data collection in clinical nursing research: a discussion paper. Int J Nurs Stud. 2007;44:1064–70.CrossRef Musselwhite K, Cuff L, McGregor L, King KM. The telephone interview is an effective method of data collection in clinical nursing research: a discussion paper. Int J Nurs Stud. 2007;44:1064–70.CrossRef
20.
go back to reference Ghanouni A, Renzi C, Meisel SF, Waller J. Common methods of measuringInformed choice’ in screening participation: challenges and future directions. Prev Med Rep. 2016;28:601–7.CrossRef Ghanouni A, Renzi C, Meisel SF, Waller J. Common methods of measuringInformed choice’ in screening participation: challenges and future directions. Prev Med Rep. 2016;28:601–7.CrossRef
21.
22.
go back to reference Teare MD, Dimairo M, Shephard N, , Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomized controlled trials: a simulation study. Trials. 2014;15:264.CrossRef Teare MD, Dimairo M, Shephard N, , Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomized controlled trials: a simulation study. Trials. 2014;15:264.CrossRef
Metadata
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
Authors
Robert J. C. Steele
Jayne Digby
Julie A. Chambers
Ronan E. O’Carroll
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2019
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-019-6734-0

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