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Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial.

ABSTRACT: BACKGROUND:The decision to take up colorectal cancer screening has to be made on informed grounds balancing benefits and harms. Self-administered decision aids can support citizens in making an informed choice. A self-administered web-based decision aid targeting citizens with lower educational attainment has been evaluated within the target population. However, the effectiveness in the general screening population remains unexplored. The aim of this study was to evaluate the effectiveness of a web-based decision aid for colorectal cancer screening on components of informed choice among previous non-participants in colorectal cancer screening. METHODS AND FINDINGS:The study was designed as a parallel randomised controlled trial among non-participants in colorectal cancer screening in Central Denmark Region (men and women aged 53-74 years). Respondents to baseline and follow-up questionnaires comprised the study population (n = 1,723). The intervention group received the decision aid electronically along with the second reminder. The control group received only the second reminder. The main outcomes (knowledge, attitudes, uptake and decisional conflict) were obtained through questionnaires data and from the Danish Colorectal Cancer Screening Database. The decision aid increased the uptake rate by 8 percentage points (95% CI: 3.4;12.6) but had no effect on either knowledge (scale score differences: 0.09; 95% CI: -0.05;0.24) or attitudes (0.45; 95% CI: -0.00;0.91). Decisional conflict decreased by 1.69 scale points (95% CI: -3.18;-0.20). The effect was similar across educational attainment levels. CONCLUSIONS:The web-based decision aid offers a feasible way to provide individualised screening information in a "one size fits all" approach that may hold the potential to increase informed CRC screening uptake. TRIAL REGISTRATION:ClinicalTrials.gov registration number: NCT03253888.

SUBMITTER: Gabel P

PROVIDER: S-EPMC7654753 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial.

Gabel Pernille P Larsen Mette Bach MB Edwards Adrian A Kirkegaard Pia P Andersen Berit B

PloS one 20201110 11

<h4>Background</h4>The decision to take up colorectal cancer screening has to be made on informed grounds balancing benefits and harms. Self-administered decision aids can support citizens in making an informed choice. A self-administered web-based decision aid targeting citizens with lower educational attainment has been evaluated within the target population. However, the effectiveness in the general screening population remains unexplored. The aim of this study was to evaluate the effectivene ...[more]

PMID: 33170877

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Project description:Decision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.To determine whether a decision aid increases informed choice about mammography screening programme participation.A representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and ?2-tests.1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention.This paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public.German Clinical Trials Register DRKS00005176.

Project description:Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.ClinicalTrials.gov: NCT00967824

Project description:The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice (evaluated based on knowledge, attitudes and actual participation). The study includes three study arms. Citizens to be recruited are identified from the Danish Civil Registration System based on residence (Central Denmark Region), age (50-74 years old), and month of birth. A random sample of 15,000 citizens born in December (invited for CRC screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in October (invited for CRC screening in January/February 2017) (study arm 3) is identified. Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge, attitudes, worry, and health literacy. Non respondents will receive one reminder after two weeks and after four weeks non-respondents will receive a phone call, offering them to fill out the questionnaire via the phone. Baseline questionnaire respondents are included in the study, and will be randomized into two study arms (intervention group and control group). Citizens in the intervention group will be identified in the screening IT system. Date of screening invitation and screening reminder (citizens who do not return a stool sample within 45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens have six weeks to respond to the questionnaire. Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same time as the baseline questionnaires are sent out to the intervention and control groups. The citizens are included if they respond to the questionnaire within six weeks. Questionnaire reminders are sent out at two and four weeks. Data on screening invitation date, screening reminder date, returning a stool sample and result will be retrieved from the screening IT system for all included citizens (Study arm 1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors) will be included.

Project description:BACKGROUND:Citizens with lower educational attainments (EA) take up colorectal cancer screening to a lesser degree, and more seldom read and understand conventional screening information than citizens with average EAs. The information needs of citizens with lower EA are diverse, however, with preferences ranging from wanting clear recommendations to seeking detailed information about screening. Decision aids have been developed to support citizens with lower EA in making informed decisions about colorectal cancer screening participation, but none embrace diverse information needs. OBJECTIVE:The aim of this study was to develop a self-administered decision aid for participation in fecal immunochemical test-based colorectal cancer screening. The decision aid should be tailored to citizens with lower EA and should embrace diverse information needs. METHODS:The Web-based decision aid was developed according to an international development framework, with specific steps for designing, alpha testing, peer reviewing, and beta testing the decision aid. In the design phase, a prototype of the decision aid was developed based on previous studies about the information needs of lower EA citizens and the International Patient Decision Aid Standards guidelines. Alpha testing was conducted using focus group interviews and email correspondence. Peer review was conducted using email correspondence. Both tests included both lower EA citizens and health care professionals. The beta testing was conducted using telephone interviews with citizens with lower EA. Data were analyzed using thematic analysis. RESULTS:The developed decision aid presented information in steps, allowing citizens to read as much or as little as wanted. Values clarification questions were included after each section of information, and answers were summarized in a "choice-indicator" on the last page, guiding the citizens toward a decision about screening participation. Statistics were presented in both natural frequencies, absolute risk formats and graphically. The citizens easily and intuitively navigated around the final version of the decision aid and stated that they felt encouraged to think about the benefits and harms of colorectal cancer screening without being overloaded with information. They found the decision aid easy to understand and the text of suitable length. The health care professionals agreed with the citizens on most parts; however, concerns were raised about the length and readability of the text. CONCLUSIONS:We have developed a self-administered decision aid presenting information in steps. We involved both citizens and health care professionals to target the decision aid for citizens with lower EA. This decision aid represents a new way of communicating detailed information and may be able to enhance informed choices about colorectal cancer screening participation among citizens with lower EA.

Project description:ObjectiveTo determine whether a decision aid designed for adults with low education and literacy can support informed choice and involvement in decisions about screening for bowel cancer.DesignRandomised controlled trial.SettingAreas in New South Wales, Australia identified as socioeconomically disadvantaged (low education attainment, high unemployment, and unskilled occupations).Participants572 adults aged between 55 and 64 with low educational attainment, eligible for bowel cancer screening.InterventionPatient decision aid comprising a paper based interactive booklet (with and without a question prompt list) and a DVD, presenting quantitative risk information on the possible outcomes of screening using faecal occult blood testing compared with no testing. The control group received standard information developed for the Australian national bowel screening programme. All materials and a faecal occult blood test kit were posted directly to people's homes.Main outcome measuresInformed choice (adequate knowledge and consistency between attitudes and screening behaviour) and preferences for involvement in screening decisions.ResultsParticipants who received the decision aid showed higher levels of knowledge than the controls; the mean score (maximum score 12) for the decision aid group was 6.50 (95% confidence interval 6.15 to 6.84) and for the control group was 4.10 (3.85 to 4.36; P<0.001). Attitudes towards screening were less positive in the decision aid group, with 51% of the participants expressing favourable attitudes compared with 65% of participants in the control group (14% difference, 95% confidence interval 5% to 23%; P=0.002). The participation rate for screening was reduced in the decision aid group: completion of faecal occult blood testing was 59% v 75% in the control group (16% difference, 8% to 24%; P=0.001). The decision aid increased the proportion of participants who made an informed choice, from 12% in the control group to 34% in the decision aid group (22% difference, 15% to 29%; P<0.001). More participants in the decision aid group had no decisional conflict about the screening decision compared with the controls (51% v 38%; P=0.02). The groups did not differ for general anxiety or worry about bowel cancer.ConclusionsTailored decision support information can be effective in supporting informed choices and greater involvement in decisions about faecal occult blood testing among adults with low levels of education, without increasing anxiety or worry about developing bowel cancer. Using a decision aid to make an informed choice may, however, lead to lower uptake of screening. Trial registration ClinicalTrials.gov NCT00765869 and Australian New Zealand Clinical Trials Registry 12608000011381.

Dataset Information

Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial.

Publications

Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial.

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