Decision-making in the multiphase optimization strategy: Applying decision analysis for intervention value efficiency to optimize an information leaflet to promote key antecedents of medication adherence.

Advances in the multiphase optimization strategy (MOST) have suggested a new approach, decision analysis for intervention value efficiency (DAIVE), for selecting an optimized intervention based on the results of a factorial optimization trial. The new approach opens possibilities to select optimized interventions based on multiple valued outcomes. We applied DAIVE to identify an optimized information leaflet intended to support eventual adherence to adjuvant endocrine therapy for women with breast cancer. We used empirical performance data for five candidate leaflet components on three hypothesized antecedents of adherence: beliefs about the medication, objective knowledge about AET, and satisfaction with medication information. Using data from a 25 factorial trial (n = 1603), we applied the following steps: (i) We used Bayesian factorial analysis of variance to estimate main and interaction effects for the five factors on the three outcomes. (ii) We used posterior distributions for main and interaction effects to estimate expected outcomes for each leaflet version (32 total). (iii) We scaled and combined outcomes using a linear value function with predetermined weights indicating the relative importance of outcomes. (iv) We identified the leaflet that maximized the value function as the optimized leaflet, and we systematically varied outcome weights to explore robustness. The optimized leaflet included two candidate components, side-effects, and patient input, set to their higher levels. Selection was generally robust to weight variations consistent with the initial preferences for three outcomes. DAIVE enables selection of optimized interventions with the best-expected performance on multiple outcomes.

Intervention optimization involves using data from an optimization trial to select the combination of intervention components that are expected to successfully balance effectiveness (i.e. improving an outcome in the desired direction) with efficiency (i.e. producing a good outcome without wasting resources). Recently, a new method for selecting optimized interventions has been proposed that has a number of advantages, including the ability to use empirical information about more than one outcome variable of interest. Here, we applied this new method to identify an optimized information leaflet designed to support eventual medication adherence in women with breast cancer, using empirical information about three outcome variables that are thought to be important for later medication adherence: beliefs about the medication, objective knowledge about the medication, and satisfaction with the leaflet information. When we let beliefs about the medication be most important; knowledge about the medication to be half as important as beliefs; and satisfaction with information to be half as important as knowledge, the optimized leaflet included enhanced information about side-effects and photos and quotes from women with breast cancer. This decision remained generally the same when we systematically varied the weights used to give outcomes their relative importance.

Acceptability of receiving lifestyle advice at cervical, breast and bowel cancer screening.

Cancer screening could be an opportunity to deliver cancer prevention advice, but it is not known how such information would be received. We explored willingness to receive lifestyle advice in the context of the English National Health Service cervical, breast, and bowel (FS; flexible sigmoidoscopy) screening programmes. A population-based survey was conducted in 2016 to collect nationally representative data on willingness to receive lifestyle advice across cervical (n = 768), breast (n = 420) and FS (n = 308) screening programmes. Additional items assessed the impact of lifestyle advice on screening attendance, preference for receiving advice in the event of an abnormal screening result, and timing of advice. Most respondents were willing to receive lifestyle advice around the time of cancer screening (cervical 78.9%, breast 79.4%, FS 81.8%), and if their results were abnormal (cervical 86.3%, breast 83.0%, FS 85.1%). A small proportion indicated it may discourage future attendance (cervical 4.9%, breast 7.0%, FS 8.8%). Most preferred information to be delivered at the screening appointment (cervical 69.8%, breast 72.6%, FS 70.7%). There were no associations between sociodemographic characteristics and willingness to receive lifestyle advice at breast screening. For those intending to attend cervical screening, non-White ethnicity and higher education were associated with increased willingness to receive lifestyle advice. Women were more likely to be willing to receive advice at FS screening than men. Providing lifestyle advice at cancer screening is likely to be acceptable to the general population. The optimal approach for delivery needs careful consideration to minimise potential negative effects on screening attendance.

Development and Validation of the Consumer Health Activation Index.

BACKGROUND: Although there has been increasing interest in patient engagement, few measures are publicly available and suitable for patients with limited health literacy. OBJECTIVE: We sought to develop a Consumer Health Activation Index (CHAI) for use among diverse patients. METHODS: Expert opinion, a systematic literature review, focus groups, and cognitive interviews with patients were used to create and revise a potential set of items. Psychometric testing guided by item response theory was then conducted among 301 English-speaking, community-dwelling adults. This included differential item functioning analyses to evaluate item performance across participant health literacy levels. To determine construct validity, CHAI scores were compared to scales measuring similar personality constructs. Associations between the CHAI and physical and mental health established predictive validity. A second study among 9,478 adults was used to confirm CHAI associations with health outcomes. RESULTS: Exploratory factor analyses revealed a single-factor solution with a 10-item scale. The CHAI showed good internal consistency (alpha = 0.81) and moderate test-retest reliability (ICC = 0.53). Reading grade level was found to be at the 6th grade. Moderate to strong correlations were found with similar constructs (Multidimensional Health Locus of Control, r = 0.38, P < 0.001; Conscientiousness, r = 0.41, P < 0.001). Predictive validity was demonstrated through associations with functional health status measures (depression, r = -0.28, P < 0.001; anxiety, r = -0.22, P < 0.001; and physical functioning, r = 0.22, P < 0.001). In the validation sample, the CHAI was significantly associated with self-reported physical and mental health ( r = 0.31 and 0.32 respectively; both P < 0.001). CONCLUSIONS: The CHAI appears to be a valid, reliable, and easily administered tool that can be used to assess health activation among adults, including those with limited health literacy. Future studies should test the tool in actual use and explore further applications.

Reducing the socioeconomic gradient in uptake of the NHS bowel cancer screening Programme using a simplified supplementary information leaflet: a cluster-randomised trial.

BACKGROUND: Uptake of colorectal cancer screening is low in the English NHS Bowel Cancer Screening Programme (BCSP). Participation in screening is strongly associated with socioeconomic status. The aim of this study was to determine whether a supplementary leaflet providing the 'gist' of guaiac-based Faecal Occult Blood test (gFOBt) screening for colorectal cancer could reduce the socioeconomic status (SES) gradient in uptake in the English NHS BCSP. METHODS: The trial was integrated within routine BCSP operations in November 2012. Using a cluster randomised controlled design all adults aged 59-74 years who were being routinely invited to complete the gFOBt were randomised based on day of invitation. The Index of Multiple Deprivation was used to create SES quintiles. The control group received the standard information booklet ('SI'). The intervention group received the SI booklet and the Gist leaflet ('SI + Gist') which had been designed to help people with lower literacy engage with the invitation. Blinding of hubs was not possible and invited subjects were not made aware of a comparator condition. The primary outcome was the gradient in uptake across IMD quintiles. RESULTS: In November 2012, 163,525 individuals were allocated to either the 'SI' intervention (n = 79,104) or the 'SI + Gist' group (n = 84,421). Overall uptake was similar between the intervention and control groups (SI: 57.3% and SI + Gist: 57.6%; OR = 1.02, 95% CI: 0.92-1.13, p = 0.77). Uptake was 42.0% (SI) vs. 43.0% (SI + Gist) in the most deprived quintile and 65.6% vs. 65.8% in the least deprived quintile (interaction p = 0.48). The SES gradient in uptake was similar between the study groups within age, gender, hub and screening round sub-groups. CONCLUSIONS: Providing supplementary simplified information in addition to the standard information booklet did not reduce the SES gradient in uptake in the NHS BCSP. The effectiveness of the Gist leaflet when used alone should be explored in future research. TRIAL REGISTRATION: ISRCTN74121020 , registered: 17/20/2012.

A national cluster-randomised controlled trial to examine the effect of enhanced reminders on the socioeconomic gradient in uptake in bowel cancer screening.

BACKGROUND: The NHS Bowel Cancer Screening Programme in England offers biennial guaiac faecal occult blood testing (gFOBt). There is a socioeconomic gradient in participation and socioeconomically disadvantaged groups have worse colorectal cancer survival than more advantaged groups. We compared the effectiveness and cost of an enhanced reminder letter with the usual reminder letter on overall uptake of gFOBt and the socioeconomic gradient in uptake. METHODS: We enhanced the usual reminder by including a heading 'A reminder to you' and a short paragraph restating the offer of screening in simple language. We undertook a cluster-randomised trial of all 168 480 individuals who were due to receive a reminder over 20 days in 2013. Randomisation was based on the day of invitation. Blinding of individuals was not possible, but the possibility of bias was minimal owing to the lack of direct contact with participants. The enhanced reminder was sent to 78 067 individuals and 90 413 received the usual reminder. The primary outcome was the proportion of people adequately screened and its variation by quintile of Index of Multiple Deprivation. Data were analysed by logistic regression with conservative variance estimates to take account of cluster randomisation. RESULTS: There was a small but statistically significant (P=0.001) increase in participation with the enhanced reminder (25.8% vs 25.1%). There was significant (P=0.005) heterogeneity of the effect by socioeconomic status with an 11% increase in the odds of participation in the most deprived quintile (from 13.3 to 14.1%) and no increase in the least deprived. We estimated that implementing the enhanced reminder nationally could result in up to 80 more people with high or intermediate risk colorectal adenomas and up to 30 more cancers detected each year if it were implemented nationally. The intervention incurred a small one-off cost of £78 000 to modify the reminder letter. CONCLUSIONS: The enhanced reminder increases overall uptake and reduces the socioeconomic gradient in bowel cancer screening participation at little additional cost.

Evaluating the impact of a community-based cancer awareness roadshow on awareness, attitudes and behaviors.

Improving public awareness of cancer and encouraging health behavior change are important aspects of cancer control. We investigated whether a community-based roadshow was an effective way of communicating with the public about cancer and encouraging behavior change. Data were from 1196 people who completed questionnaires at a Cancer Research UK Cancer Awareness Roadshow in 2013. Of these, 511 (43%) completed questionnaires immediately before their visit (pre-visit group) and 685 (57%) completed questionnaires immediately after their visit (post-visit group). Among the post-visit sample, 217 (32%) were retained after two months. Self-reported data were available on risk factor and symptom awareness, help-seeking barriers, use of healthcare services and health behaviors. Compared with the pre-visit sample, the post-visit group had greater awareness of cancer risk factors and was more positive about aspects of help-seeking but awareness of potential symptoms was similar. Most effects were maintained over two months. Intentions to eat more fruit and vegetables and to exercise more were comparable between the groups but more people in the post-visit sample intended to quit smoking. At 2-month follow-up, smoking prevalence had significantly reduced but fruit and vegetable consumption decreased and there was no change to physical activity. User of weight loss services and general practitioner visits were high at follow-up and largely attributed to the Roadshow. The Cancer Research UK Roadshow appears to improve risk factor awareness, promote positive attitudes towards help-seeking and increase smoking cessation. This approach could be a useful building block for additional cancer prevention and control strategies.

The Role of Patient Activation in Preferences for Shared Decision Making: Results From a National Survey of U.S. Adults.

Studies investigating preferences for shared decision making (SDM) have focused on associations with sociodemographic variables, with few investigations exploring patient factors. We aimed to investigate the relationship between patient activation and preferences for SDM in 6 common medical decisions among a nationally representative cross-sectional survey of American adults. Adults older than 18 were recruited online (n = 2,700) and by telephone (n = 700). Respondents completed sociodemographic assessments and the Patient Activation Measure. They were also asked whether they perceived benefit (yes/no) in SDM in 6 common medical decisions. Nearly half of the sample (45.9%) reached the highest level of activation (Level 4). Activation was associated with age (p < .001), higher income (p = .001), higher education (p = .010), better self-rated health (p < .001), and fewer chronic conditions (p = .050). The proportion of people who agreed that SDM was beneficial varied from 53.1% (deciding the necessity of a diagnostic test) to 71.8% (decisions associated with making lifestyle changes). After we controlled for participant characteristics, higher activation was associated with greater perceived benefit in SDM across 4 of the 6 decisions. Preferences for SDM varied among 6 common medical scenarios. Low patient activation is an important barrier to SDM that could be ameliorated through the development of behavioral interventions.

Effects of evidence-based strategies to reduce the socioeconomic gradient of uptake in the English NHS Bowel Cancer Screening Programme (ASCEND): four cluster-randomised controlled trials.

BACKGROUND: Uptake in the national colorectal cancer screening programme in England varies by socioeconomic status. We assessed four interventions aimed at reducing this gradient, with the intention of improving the health benefits of screening. METHODS: All people eligible for screening (men and women aged 60-74 years) across England were included in four cluster-randomised trials. Randomisation was based on day of invitation. Each trial compared the standard information with the standard information plus the following supplementary interventions: trial 1 (November, 2012), a supplementary leaflet summarising the gist of the key information; trial 2 (March, 2012), a supplementary narrative leaflet describing people's stories; trial 3 (June, 2013), general practice endorsement of the programme on the invitation letter; and trial 4 (July-August, 2013) an enhanced reminder letter with a banner that reiterated the screening offer. Socioeconomic status was defined by the Index of Multiple Deprivation score for each home address. The primary outcome was the socioeconomic status gradient in uptake across deprivation quintiles. This study is registered, number ISRCTN74121020. FINDINGS: As all four trials were embedded in the screening programme, loss to follow-up was minimal (less than 0·5%). Trials 1 (n=163,525) and 2 (n=150,417) showed no effects on the socioeconomic gradient of uptake or overall uptake. Trial 3 (n=265 434) showed no effect on the socioeconomic gradient but was associated with increased overall uptake (adjusted odds ratio [OR] 1·07, 95% CI 1·04-1·10, p<0·0001). In trial 4 (n=168 480) a significant interaction was seen with socioeconomic status gradient (p=0·005), with a stronger effect in the most deprived quintile (adjusted OR 1·11, 95% CI 1·04-1·20, p=0·003) than in the least deprived (1·00, 0·94-1·06, p=0·98). Overall uptake was also increased (1·07, 1·03-1·11, p=0·001). INTERPRETATION: Of four evidence-based interventions, the enhanced reminder letter reduced the socioeconomic gradient in screening uptake, but further reducing inequalities in screening uptake through written materials alone will be challenging. FUNDING: National Institute for Health Research.

Disparities in registration and use of an online patient portal among older adults: findings from the LitCog cohort.

OBJECTIVE: To document disparities in registration and use of an online patient portal among older adults. MATERIALS AND METHODS: Data from 534 older adults were linked with information from the Northwestern Medicine Electronic Data Warehouse on patient portal registration and use of functions (secure messaging, prescription reauthorizations, checking test results, and monitoring vital statistics). Age, gender, race, education, self-reported chronic conditions, and the Newest Vital Sign health literacy measure were available from cohort data. RESULTS: Most patients (93.4%) had a patient portal access code generated for them, and among these 57.5% registered their accounts. In multivariable analyses, White patients (P < .001) and college graduates were more likely to have registered their patient portal (P = .015). Patients with marginal (P = .034) or adequate (P < .001) health literacy were also more likely to have registered their patient portal. Among those registering their accounts, most had messaged their physician (90%), checked a test result (96%), and ordered a reauthorization (55%), but few monitored their vital statistics (11%). Adequate health literacy patients were more likely to have used the messaging function (P = .003) and White patients were more likely to have accessed test results (P = .004). Higher education was consistently associated with prescription reauthorization requests (all P < .05). DISCUSSION: Among older American adults, there are stark health literacy, educational, and racial disparities in the registration, and subsequent use of an online patient portal. These population sub-group differences may exacerbate existing health disparities. CONCLUSIONS: If patient portals are implemented, intervention strategies are needed to monitor and reduce disparities in their use.

Low health literacy predicts decline in physical function among older adults: findings from the LitCog cohort study.

BACKGROUND: Limited health literacy is associated with worse physical function in cross-sectional studies. We aimed to determine if health literacy is a risk factor for decline in physical function among older adults. METHODS: A longitudinal cohort of 529 community-dwelling American adults aged 55-74 years were recruited from an academic general internal medicine clinic and federally qualified health centres in 2008-2011. Health literacy (Newest Vital Sign), age, gender, race, education, chronic conditions, body mass index, alcohol consumption, smoking status and exercise frequency were included in multivariable analyses. The 10-item PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale was assessed at baseline and follow-up (mean=3.2 years, SD=0.39). RESULTS: Nearly half of the sample (48.2%) had either marginal (25.5%) or low health literacy (22.7%). Average physical function at baseline was 83.2 (SD=16.6) of 100, and health literacy was associated with poorer baseline physical function in multivariable analysis (p=0.004). At follow-up, physical function declined to 81.9 (SD=17.3; p=0.006) and 20.5% experienced a meaningful decline (>0.5 SD of baseline score). In multivariable analyses, participants with marginal (OR 2.62; 95%CI 1.38 to 4.95; p=0.003) and low (OR 2.57; 95%CI 1.22 to 5.44; p=0.013) health literacy were more likely to experience meaningful decline in physical function than the adequate health literacy group. Entering cognitive abilities to these models did not substantially attenuate effect sizes. Health literacy attenuated the relationship between black race and decline in physical function by 32.6%. CONCLUSIONS: Lower health literacy increases the risk of exhibiting faster physical decline over time among older adults. Strategies that reduce literacy disparities should be designed and evaluated.

The association between patient activation and accessing online health information: results from a national survey of US adults.

BACKGROUND: There are increasing opportunities for the public to access online health information, but attitudinal barriers to use are less well-known. Patient activation is associated with key health outcomes, but its relationship with using online health information is not known. OBJECTIVE: We examined the relationship between patient activation and the likelihood of accessing a range of different types of online health information in a nationally representative US sample. DESIGN: Cross-sectional nationally representative survey. SETTING AND PARTICIPANTS: Data were from an online (n = 2700) and random digit dial telephone survey (n = 700) of US adults (total n = 3400). MAIN VARIABLES STUDIED: Respondent characteristics and the Patient Activation Measure. MAIN OUTCOME MEASURES: Self-reported access of five types of online health information in the past 12 months (online medical records, cost estimation tools, quality comparison tools, health information about a specific condition, preventive health information). RESULTS: Approximately, one-fifth of the sample had accessed their medical record (21.6%), treatment cost estimation tools (17.3%) and hospital and physician quality comparison tools (21.8%). Nearly half of the sample had accessed information about medical conditions or treatments (48.3%) or preventive health and well-being (45.9%). In multivariable analyses adjusted for participant characteristics, respondents with greater patient activation were more likely to have accessed all types of health information other than cost estimation tools. DISCUSSION AND CONCLUSIONS: Activated people are more likely to make use of online heath information. Increasing patient activation could improve the public's ability to participate in health care and personal health self-management by encouraging health information seeking.

Health literacy, cognitive ability, and functional health status among older adults.

OBJECTIVE: To investigate whether previously noted associations between health literacy and functional health status might be explained by cognitive function. DATA SOURCES/STUDY SETTING: Health Literacy and Cognition in Older Adults ("LitCog," prospective study funded by National Institute on Aging). Data presented are from interviews conducted among 784 adults, ages 55-74 years receiving care at an academic general medicine clinic or one of four federally qualified health centers in Chicago from 2008 to 2010. STUDY DESIGN: Study participants completed structured, in-person interviews administered by trained research assistants. DATA COLLECTION: Health literacy was measured using the Test of Functional Health Literacy in Adults, Rapid Estimate of Adult Literacy in Medicine, and Newest Vital Sign. Cognitive function was assessed using measures of long-term and working memory, processing speed, reasoning, and verbal ability. Functional health was assessed with SF-36 physical health summary scale and Patient Reported Outcomes Measurement Information System short form subscales for depression and anxiety. PRINCIPAL FINDINGS: All health literacy measures were significantly correlated with all cognitive domains. In multivariable analyses, inadequate health literacy was associated with worse physical health and more depressive symptoms. After adjusting for cognitive abilities, associations between health literacy, physical health, and depressive symptoms were attenuated and no longer significant. CONCLUSIONS: Cognitive function explains a significant proportion of the associations between health literacy, physical health, and depression among older adults. Interventions to reduce literacy disparities in health care should minimize the cognitive burden in behaviors patients must adopt to manage personal health.

Improving cancer control through a community-based cancer awareness initiative.

OBJECTIVE: To assess the impact of the Cancer Research UK Cancer Awareness Roadshow on intentions to change health behaviours and use local health services related to cancer. METHOD: Feedback forms from visitors to three Roadshows collected data on anticipated lifestyle changes and health service use following their visit to the Roadshow. Demographic predictors of intentions were investigated. RESULTS: A total of 6009 individuals completed a feedback form. On average, respondents intended to make between two and three (2.55; SD=1.77) lifestyle changes, and use between none and one (0.59; SD=0.77) local health services following their visit. Multivariable analysis showed that age (p=0.001), ethnicity (p=0.006), and occupation (p=0.043) were significant predictors of anticipated lifestyle changes. Anticipated health service use was higher among men (p=0.001), younger groups (p<0.001), and smokers (p<0.001). Overall effects of ethnicity (p=0.001) and occupation (p<0.001) on anticipated health service use were also observed. Post-hoc analyses indicated stronger effects of the Roadshow among disadvantaged groups. CONCLUSION: High levels of anticipated health behaviour change and health service use were observed among Roadshow visitors. Disadvantaged groups such as lower socioeconomic groups, ethnic minorities, and smokers showed particularly high levels of intention. A more in-depth evaluation of the Roadshow is warranted.

Public perceptions and preferences for CT colonography or colonoscopy in colorectal cancer screening.

OBJECTIVES: To examine public perceptions of and preferences for colonoscopy vs. CT colonography (CTC) as technologies for colorectal cancer (CRC) screening. METHODS: Six discussion groups were carried out with 30 adults aged 49-60 years (60% female). Information about different aspects of the tests (e.g. sensitivity, practical issues) was presented sequentially using a semi-structured, step-by-step topic guide. Discussions were recorded and analyzed using framework analysis. RESULTS: CTC was favored on the parameters of invasiveness, extra-colonic evaluation and interference with daily life, whereas sensitivity, avoiding false-positives and the capacity to remove polyps immediately were perceived to be important advantages of colonoscopy. Ultimately, there was no strong preference for either test: with 46% preferring colonoscopy vs. 42% for CTC. CONCLUSION: With comprehensive information, colonoscopy and CTC were seen as having different advantages and disadvantages, yielding no clear preferences between the two. The sensitivity of colonoscopy was a decisive factor for some people, but the lower invasiveness of CTC was seen as an asset in the screening context. PRACTICE IMPLICATIONS: CTC may be an acceptable alternative to colonoscopy in CRC screening. Healthcare professionals working in the screening context should be sensitive to the range of characteristics that can determine preferences for CRC screening tests.

Socioeconomic status, statistical confidence, and patient-provider communication: an analysis of the Health Information National Trends Survey (HINTS 2007).

The increasing trend of exposing patients seeking health advice to numerical information has the potential to adversely impact patient-provider relationships especially among individuals with low literacy and numeracy skills. We used the HINTS 2007 to provide the first large scale study linking statistical confidence (as a marker of subjective numeracy) to demographic variables and a health-related outcome (in this case the quality of patient-provider interactions). A cohort of 7,674 individuals answered sociodemographic questions, a question on how confident they were in understanding medical statistics, a question on preferences for words or numbers in risk communication, and a measure of patient-provider interaction quality. Over thirty-seven percent (37.4%) of individuals lacked confidence in their ability to understand medical statistics. This was particularly prevalent among the elderly, low income, low education, and non-White ethnic minority groups. Individuals who lacked statistical confidence demonstrated clear preferences for having risk-based information presented with words rather than numbers and were 67% more likely to experience a poor patient-provider interaction, after controlling for gender, ethnicity, insurance status, the presence of a regular health care professional, and the language of the telephone interview. We will discuss the implications of our findings for health care professionals.