The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial

Background: Colorectal 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. Methods: The 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

The association between health literacy and colorectal cancer screening uptake in a publicly funded screening program in Denmark: cross-sectional study

There are multiple reasons for not participating in colorectal cancer screening, but the role of health literacy in screening uptake is not well understood. The aims of this study were to determine the association between health literacy and colorectal cancer screening uptake and to explore whether socioeconomic and -demographic characteristics and worry and attitude variables modify this association. In a cross-sectional study, 10,030 53–74-year-old randomly selected citizens resident in Central Denmark Region received a questionnaire assessing health literacy using the European Health Literacy Survey Short Scale 16-item. Data on colorectal cancer screening uptake were obtained from the Danish Colorectal Cancer Screening database, and socioeconomic and -demographic data were linked from Statistics Denmark. The response rate was 71% (n = 7142). Odds ratio (OR) for uptake was 1.06 (95% confidence interval (CI): 0.96, 1.19) for problematic health literacy and 1.00 (95% CI: 0.87, 1.16) for inadequate health literacy, when using adequate health literacy as the reference value. The association was not modified by socioeconomic or -demographic characteristics, worry or attitude. No association was found between health literacy and colorectal cancer screening uptake. Future research needs to clarify which dimensions of health literacy may predict screening uptake and how it is best measured

Depressive symptoms in women's midlife in relation to their body weight before, during and after childbearing years

OBJECTIVE: This study aimed to examine how weight and weight changes related to pregnancy were associated with depressive symptoms 11–16 years after childbirth. METHOD: We followed 16,998 first‐time mothers from the Danish National Birth Cohort up till 16 years after birth and estimated associations between depressive symptoms and pre‐pregnancy body mass index (BMI) (kg m(−2)), weight changes in different time periods, and BMI‐adjusted waist circumference 7 years after birth (WC(BMI), cm). Depressive symptoms were estimated by the Center for Epidemiologic Studies Depression 10‐item scale. Multiple logistic regression analyses were used to estimate odds ratios (OR) and 95% confidence intervals. RESULTS: Compared with normal‐weight, we found that underweight, overweight and obesity were associated with greater odds of depressive symptoms (1.29, 1.24 and 1.73, respectively). Compared with weight change ±1 BMI unit during the total follow‐up period, greater odds for depressive symptoms were observed with weight loss (OR 1.14, 0.96–1.36) or gain of 2–2.99 kg m(−2) (OR 1.11, 0.92–1.33) or gain of ≥3 kg m(−2) (OR 1.68, 1.46–1.94). WC(BMI) > 2.2 cm was associated with greater odds of depressive symptoms (OR 1.16, 0.99–1.36) than waist circumference as predicted by BMI. CONCLUSION: Low and high pre‐pregnancy BMI, weight changes and WC(BMI) larger than predicted were associated with more depressive symptoms in midlife

Knowledge, attitudes, and worries among different health literacy groups before receiving first invitation to colorectal cancer screening: cross-sectional study

Background Colorectal cancer screening uptake is associated with knowledge, attitudes and worries about screening. People with higher levels of health literacy usually have higher screening-related knowledge, but its association with attitudes and worries is sparsely described. The aim of this study was to describe knowledge, attitudes, and worries about colorectal cancer screening among unscreened citizens, and to estimate the association between these and health literacy. Methods In a cross-sectional study 10,030 53–74 year-old Central Denmark Region citizens received a questionnaire assessing knowledge, attitudes, worry and health literacy. Socioeconomic and –demographic data were linked from Statistics Denmark after data collection. Results In total, 7142 (71.2%) questionnaires were completed. A good general level of knowledge was observed (4.91 and 5.13 out of 7 for men and women, respectively). Citizens tended to be positive towards screening (21.4 and 21.3 on a 4–28 range scale for men and women respectively), and showed low levels of worries (8.8 and 9.09 on a 3–15 range scale for men and women respectively). Knowledge decreased and worries increased with lower levels of health literacy. Further, attitudes tended to be more positive with higher levels of health literacy. Conclusions In general, citizens tend to have good knowledge, positive attitudes and few worries about colorectal cancer screening. People with lower health literacy could benefit from targeted interventions that address knowledge and worries about screening to support informed decision making

The LEAD trial. The effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: a randomised controlled trial

Objectives This trial tested the effectiveness of a self-administered web-based decision aid, targeted at citizens with lower educational attainment, on informed choice about colorectal cancer screening participation as assessed by group levels of knowledge, attitudes and uptake. Methods The randomised controlled trial was conducted among 2702 screening-naïve Danish citizens, 53–74 years old, with lower educational attainment. Baseline questionnaire respondents (62%) were allocated to intervention and control groups. Intervention group citizens received the decision aid. Outcomes were informed choice, worries and decisional conflict. Results Analyses were conducted among 339 eligible citizens. The mean difference in knowledge score change between intervention and control group was 0.00 (95% confidence interval (CI): -0.38;0.38). Trends towards more positive screening attitudes (mean difference in score change: 0.72, 95% CI: -0.38;1.81) and higher screening uptake (7.6%, 95% CI:−2.2;17.4%) were observed. Worries (−0.33, 95% CI: −0.97;0.32) and decisional conflict (mean difference: −3.5, 95%CI: −7.0;−0.1) were slightly reduced. Conclusions The decision aid did not affect informed choice or knowledge. However, there were trends towards increased screening uptake and more positive screening attitudes. Practice implications Being a simple intervention and easily administered, the decision aid could represent a cost-effective way of enhancing screening uptake, and some elements of informed decision-making

Developing a self-administered decision aid for fecal immunochemical test-based colorectal cancer screening tailored to citizens with lower educational attainment: qualitative study

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

Copenhagen comorbidity in HIV infection (COCOMO) study:a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark

Abstract Background Modern combination antiretroviral therapy (cART) has improved survival for people living with HIV (PLWHIV). Non-AIDS comorbidities have replaced opportunistic infections as leading causes of mortality and morbidity, and are becoming a key health concern as this population continues to age. The aim of this study is to estimate the prevalence and incidence of non-AIDS comorbidity among PLWHIV in Denmark in the cART era and to determine risk factors contributing to the pathogenesis. The study primarily targets cardiovascular, respiratory, and hepatic non-AIDS comorbidity. Methods/design The Copenhagen comorbidity in HIV-infection (COCOMO) study is an observational, longitudinal cohort study. The study was initiated in 2015 and recruitment is ongoing with the aim of including 1500 PLWHIV from the Copenhagen area. Follow-up examinations after 2 and 10 years are planned. Uninfected controls are derived from the Copenhagen General Population Study (CGPS), a cohort study including 100,000 uninfected participants from the same geographical region. Physiological and biological measures including blood pressure, ankle-brachial index, electrocardiogram, spirometry, exhaled nitric oxide, transient elastography of the liver, computed tomography (CT) angiography of the heart, unenhanced CT of the chest and upper abdomen, and a number of routine biochemical analysis are uniformly collected in participants from the COCOMO study and the CGPS. Plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMC), urine, and stool samples are collected in a biobank for future studies. Data will be updated through periodical linking to national databases. Discussion As life expectancy for PLWHIV improves, it is essential to study long-term impact of HIV and cART. We anticipate that findings from this cohort study will increase knowledge on non-AIDS comorbidity in PLWHIV and identify targets for future interventional trials. Recognizing the demographic, clinical and pathophysiological characteristics of comorbidity in PLWHIV may help inform development of new guidelines and enable us to move forward to a more personalized HIV care. Trial registration ClinicalTrials.gov: NCT02382822