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Developing a Self-Administered Decision Aid for Fecal Immunochemical Test-Based Colorectal Cancer Screening Tailored to Citizens With Lower Educational Attainment: Qualitative Study.

ABSTRACT: 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.

SUBMITTER: Gabel P

PROVIDER: S-EPMC6334704 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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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:BackgroundColorectal cancer screening participation is a preference-sensitive choice, in which trade-offs between benefits and harms must be made by individual citizens. Often the decision is made without any contact with healthcare professionals. Citizens with lower educational attainment tend to participate less in colorectal cancer screening than citizens with average educational attainment. Further, they tend to have lower levels of knowledge about colorectal cancer screening. Providing lower educational attainment citizens with a targeted decision aid embracing their diverse information needs might increase these citizens' ability to make informed decisions. The aim of this trial is to test the effectiveness of such a newly developed self-administered decision aid.MethodsThe LEAD (Lower Educational Attainment Decision aid) trial will be conducted as a two-arm randomized controlled trial among 10,000 50-74-year-old citizens, resident in the Central Denmark Region not yet invited to take up colorectal cancer screening. Citizens will receive a baseline questionnaire. Respondents will be allocated into the intervention or the control groups. Citizens in the intervention group will receive the decision aid whereas the control group will not. Those who return a stool sample within 45 days after receiving the screening invitation and those with medium or higher educational attainment are excluded. Both groups will receive a follow-up questionnaire 90 days after being invited to colorectal cancer screening. A historic cohort consisting of 5000 50-74-year-old citizens resident in the Central Denmark Region, having received their screening invitation in the beginning of 2017 will be included. This cohort will receive a follow-up questionnaire 6-9 months after they received the screening invitation. Informed choice will be evaluated by assessing levels of knowledge, attitudes, and screening uptake. Analyses will be conducted as intention-to-treat analyses. Additionally, differences between levels of worry and decisional conflict between groups will be assessed as secondary outcomes.DiscussionThis trial will evaluate whether a targeted decision aid is a feasible way of enhancing informed choice among lower educational attainment citizens in colorectal cancer screening. Further, it may guide decisions about providing information material in cancer screening in general.Trial registrationClinicalTrials.gov, NCT03253888 . Registered on 17 August 2017.

Project description:Background & aimsNoninvasive tests used in colorectal cancer screening, such as the fecal immunochemical test (FIT), are more acceptable but detect neoplasias with lower levels of sensitivity than colonoscopy. We investigated whether lowering the cut-off concentration of hemoglobin for designation as an abnormal FIT result increased the detection of advanced neoplasia in a mailed outreach program.MethodsWe performed a prospective study of 17,017 uninsured patients, age 50 to 64 years, who were not current with screening and enrolled in a safety-net system in Texas. We reduced the cut-off value for an abnormal FIT result from 20 or more to 10 or more ?g hemoglobin/g feces a priori. All patients with abnormal FIT results were offered no-cost diagnostic colonoscopy. We compared proportions of patients with abnormal FIT results and neoplasia yield for standard vs lower cut-off values, as well as absolute hemoglobin concentration distribution among 5838 persons who completed the FIT. Our primary aim was to determine the effects of implementing a lower hemoglobin concentration cut-off value on colonoscopy demand and yield, specifically colorectal cancer (CRC) and advanced neoplasia detection, compared with the standard, higher, hemoglobin concentration cut-off value.ResultsThe proportions of patients with abnormal FIT results were 12.3% at the 10 or more ?g hemoglobin/g feces and 6.6% at the standard 20 or more ?g hemoglobin/g feces cut-off value (P = .0013). Detection rates for the lower vs the standard threshold were 10.2% vs 12.7% for advanced neoplasia (P = .12) and 0.9% vs 1.2% for CRC (P = .718). The positive predictive values were 18.9% for the lower threshold vs 24.4% for the standard threshold for advanced neoplasia (P = .053), and 1.7% vs 2.4% for CRC (P = .659). The number needed to screen to detect 1 case with advanced neoplasia was 45 at the lower threshold compared with 58 at the standard threshold; the number needed to scope to detect 1 case with advanced neoplasia increased from 4 to 5. Most patients with CRC (72.7%) or advanced adenoma (67.3%) had hemoglobin concentrations of 20 or more ?g/g feces. In the group with 10 to 19 ?g hemoglobin/g feces, there were 3 patients with CRC (3 of 11; 27.3%) and 36 with advanced adenoma (36 of 110; 32.7%) who would not have been detected at the standard positive threshold (advanced neoplasia Pcomparison < .001). The proportion of patients found to have no neoplasia after an abnormal FIT result (false positives) was not significantly higher with the lower cut-off value (44.4%) than the standard cut-off value (39.1%) (P = .1103).ConclusionsIn a prospective study of 17,017 uninsured patients, we found that reducing the abnormal FIT result cut-off value (to ?10 ?g hemoglobin/g feces) might increase detection of advanced neoplasia, but doubled the proportion of patients requiring a diagnostic colonoscopy. If colonoscopy capacity permits, health systems that use quantitative FITs should consider lowering the abnormal cut-off value to optimize CRC detection and prevention. (ClinicalTrials.gov no: NCT01946282.).

Project description:BACKGROUND: Previous studies have suggested that the immunochemical fecal occult blood test has superior specificity for detecting bleeding in the lower gastrointestinal tract even if bleeding occurs in the upper tract. We conducted a large population-based study involving asymptomatic adults in Taiwan, a population with prevalent upper gastrointestinal lesions, to confirm this claim. METHODS: We conducted a prospective cohort study involving asymptomatic people aged 18 years or more in Taiwan recruited to undergo an immunochemical fecal occult blood test, colonoscopy and esophagogastroduodenoscopy between August 2007 and July 2009. We compared the prevalence of lesions in the lower and upper gastrointestinal tracts between patients with positive and negative fecal test results. We also identified risk factors associated with a false-positive fecal test result. RESULTS: Of the 2796 participants, 397 (14.2%) had a positive fecal test result. The sensitivity of the test for predicting lesions in the lower gastrointestinal tract was 24.3%, the specificity 89.0%, the positive predictive value 41.3%, the negative predictive value 78.7%, the positive likelihood ratio 2.22, the negative likelihood ratio 0.85 and the accuracy 73.4%. The prevalence of lesions in the lower gastrointestinal tract was higher among those with a positive fecal test result than among those with a negative result (41.3% v. 21.3%, p < 0.001). The prevalence of lesions in the upper gastrointestinal tract did not differ significantly between the two groups (20.7% v. 17.5%, p = 0.12). Almost all of the participants found to have colon cancer (27/28, 96.4%) had a positive fecal test result; in contrast, none of the three found to have esophageal or gastric cancer had a positive fecal test result (p < 0.001). Among those with a negative finding on colonoscopy, the risk factors associated with a false-positive fecal test result were use of antiplatelet drugs (adjusted odds ratio [OR] 2.46, 95% confidence interval [CI] 1.21-4.98) and a low hemoglobin concentration (adjusted OR 2.65, 95% CI 1.62-4.33). INTERPRETATION: The immunochemical fecal occult blood test was specific for predicting lesions in the lower gastrointestinal tract. However, the test did not adequately predict lesions in the upper gastrointestinal tract.

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Developing a Self-Administered Decision Aid for Fecal Immunochemical Test-Based Colorectal Cancer Screening Tailored to Citizens With Lower Educational Attainment: Qualitative Study.

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