Patient responses to genetic information: Studies of patients with hereditary cancer syndromes identify issues for use of genetic testing in nephrology practice

Advances in the genetic basis of kidney disease may mean that genetic testing is increasingly important in reducing disease morbidity and mortality among patients. However, there is little research examining patient responses to genetic information for Mendelian and common kidney diseases. Existing research on kidney and other hereditary cancer syndromes can inform three major issues relevant to the nephrology context: (1) how patients understand their risk of disease following genetic counseling and testing; (2) their emotional responses to the information; and (3) their uptake of recommended risk-reducing strategies. Prior research suggests that genetic counseling and testing may improve patient understanding of genetics, but patients still might not fully understand the meaning of their results for disease risk. Genetic counseling and testing does not appear to result in long-term negative emotional effects among patients who carry mutations or those who do not. Finally, while genetic counseling and testing may improve adherence to recommended screening strategies, adherence varies substantially across different risk-reduction options. Previous research also suggests that computer-based interventions might be a useful adjunct to genetic counseling approaches. Examining whether and how these prior findings relate to the context of hereditary kidney disease is an important area for future research

Decision aids can support cancer clinical trials decisions: Results of a randomized trial

BACKGROUND. Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center’s website. METHODS. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center’s website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. RESULTS. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p < .0001) and less uncertainty (LS mean = 24.3 vs. 36.4, p = .025). The DA group had higher objective knowledge than the UC group’s (LS mean = 69.8 vs. 55.8, p < .0001). There were no differences between groups in intent to participate. CONCLUSIONS. Improvements on key decision outcomes including knowledge, self-efficacy, certainty about choice, and values clarity among participants who viewed the DA suggest web-based DAs can support informed decisions about trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. IMPLICATIONS FOR PRACTICE: This paper describes evidence regarding a decision tool to support patients’ decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients’ preferences, promoting patient-centered care and the ethical conduct of clinical research

Is Low Health Literacy Associated with Increased Emergency Department Utilization and Recidivism?

OBJECTIVES: The objective was to determine whether patients with low health literacy have higher emergency department (ED) utilization and higher ED recidivism than patients with adequate health literacy. METHODS: The study was conducted at an urban academic ED with more than 95,000 annual visits that is part of a 13-hospital health system, using electronic records that are captured in a central data repository. As part of a larger, cross-sectional, convenience sample study, health literacy testing was performed using the short test of functional health literacy in adults (S-TOFHLA) and standard test thresholds identifying those with inadequate, marginal, and adequate health literacy. The authors collected patients' demographic and clinical data, including items known to affect recidivism. This was a structured electronic record review directed at determining 1) the median number of total ED visits in this health system within a 2-year period and 2) the proportion of patients with each level of health literacy who had return visits within 3, 7, and 14 days of index visits. Descriptive data for demographics and ED returns are reported, stratified by health literacy level. The Mantel-Haenszel chi-square was used to test whether there is an association between health literacy and ED recidivism. A negative binomial multivariable model was performed to examine whether health literacy affects ED use, including variables significant at the 0.1 alpha level on bivariate analysis and retaining those significant at an alpha of 0.05 in the final model. RESULTS: Among 431 patients evaluated, 13.2% had inadequate, 10% had marginal, and 76.3% had adequate health literacy as identified by S-TOFHLA. Patients with inadequate health literacy had higher ED utilization compared to those with adequate health literacy (p = 0.03). Variables retained in the final model included S-TOFHLA score, number of medications, having a personal doctor, being a property owner, race, insurance, age, and simple comorbidity score. During the study period, 118 unique patients each made at least one return ED visit within a 14-day period. The proportion of patients with inadequate health literacy making at least one return visit was higher than that of patients with adequate health literacy at 14 days, but was not significantly higher within 3 or 7 days. CONCLUSIONS: In this single-center study, higher utilization of the ED by patients with inadequate health literacy when compared to those with adequate health literacy was observed. Patients with inadequate health literacy made a higher number of return visits at 14 days but not at 3 or 7 days

Secondary consent to biospecimen use in a prostate cancer biorepository

BACKGROUND: Biorepository research has substantial societal benefits. This is one of the few studies to focus on male willingness to allow future research use of biospecimens. METHODS: This study analyzed the future research consent questions from a prostate cancer biorepository study (N = 1931). The consent form asked two questions regarding use of samples in future studies (1) without and (2) with protected health information (PHI). Yes to both questions of use of samples was categorized as Yes-Always; Yes to without and No to with PHI was categorized as Yes-Conditional; No to without PHI was categorized as Never. We analyzed this outcome to determine significant predictors for consent to Yes-Always vs. Yes-Conditional. RESULTS: 99.33 % consented to future use of samples; 88.19 % consented to future use without PHI, and among those men 10.2 % consented to future use with PHI. Comparing Yes Always and Yes Conditional responses, bivariate analyses showed that race, family history, stage of cancer, and grade of cancer (Gleason), were significant at the α = 0.05 level. Using stepwise multivariable logistic regression, we found that African–American men were significantly more likely to respond Yes Always when compared to White men (p < 0.001). Those with a family history of prostate cancer were significantly more likely to respond Yes Always (p = 0.002). CONCLUSIONS: There is general willingness to consent to future use of specimens without PHI among men

Weight perceptions and perceived risk for diabetes and heart disease among overweight and obese women, Suffolk County, New York, 2008

INTRODUCTION: Many Americans fail to accurately identify themselves as overweight and underestimate their risk for obesity-related diseases. The purpose of this study was to investigate associations between weight perceptions and perceived risk for diabetes and heart disease among overweight or obese women. METHODS: We examined survey responses from 397 overweight or obese female health center patients on disease risk perceptions and weight perceptions. We derived odds ratios (ORs) and 95% confidence intervals (CIs) from multivariable logistic regression analyses to examine predictors of perceived risk for diabetes and heart disease. We further stratified results by health literacy. RESULTS: Perceiving oneself as overweight (OR, 2.78; 95% CI, 1.16-6.66), believing that being overweight is a personal health problem (OR, 2.46; 95% CI, 1.26-4.80), and family history of diabetes (OR, 3.22; 95% CI, 1.53-6.78) were associated with greater perceived risk for diabetes. Perceiving oneself as overweight (OR, 4.33; 95% CI, 1.26-14.86) and family history of heart disease (OR, 2.25; 95% CI, 1.08-4.69) were associated with greater perceived risk for heart disease. Among respondents with higher health literacy, believing that being overweight was a personal health problem was associated with greater perceived risk for diabetes (OR, 4.91; 95% CI, 1.68-14.35). Among respondents with lower health literacy, perceiving oneself as overweight was associated with greater perceived risk for heart disease (OR, 4.69; 95% CI, 1.02-21.62). CONCLUSION: Our findings indicate an association between accurate weight perceptions and perceived risk for diabetes and heart disease in overweight or obese women. This study adds to research on disease risk perceptions in at-risk populations

Do subjective measures improve the ability to identify limited health literacy in a clinical setting?

BACKGROUND: Existing health literacy assessments developed for research purposes have constraints that limit their utility for clinical practice, including time requirements and administration protocols. The Brief Health Literacy Screen (BHLS) consists of 3 self-administered Single-Item Literacy Screener (SILS) questions and obviates these clinical barriers. We assessed whether the addition of SILS items or the BHLS to patient demographics readily available in ambulatory clinical settings reaching underserved patients improves the ability to identify limited health literacy. METHODS: We analyzed data from 2 cross-sectional convenience samples of patients from an urban academic emergency department (n = 425) and a primary care clinic (n = 486) in St. Louis, Missouri. Across samples, health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R), Newest Vital Sign (NVS), and the BHLS. Our analytic sample consisted of 911 adult patients, who were primarily female (62%), black (66%), and had at least a high school education (82%); 456 were randomly assigned to the estimation sample and 455 to the validation sample. RESULTS: The analysis showed that the best REALM-R estimation model contained age, sex, education, race, and 1 SILS item (difficulty understanding written information). In validation analysis this model had a sensitivity of 62%, specificity of 81%, a positive likelihood ratio (LR(+)) of 3.26, and a negative likelihood ratio (LR(−)) of 0.47; there was a 28% misclassification rate. The best NVS estimation model contained the BHLS, age, sex, education and race; this model had a sensitivity of 77%, specificity of 72%, LR(+) of 2.75, LR(−) of 0.32, and a misclassification rate of 25%. CONCLUSIONS: Findings suggest that the BHLS and SILS items improve the ability to identify patients with limited health literacy compared with demographic predictors alone. However, despite being easier to administer in clinical settings, subjective estimates of health literacy have misclassification rates >20% and do not replace objective measures; universal precautions should be used with all patients

Screening and Health Behaviors among Persons Diagnosed with Familial Adenomatous Polyposis and Their Relatives

Familial Adenomatous Polyposis (FAP) is a rare autosomal dominantly inherited colorectal cancer syndrome. Individuals with FAP often undergo colectomy and are recommended to follow several surveillance protocols. Biological relatives of persons with FAP may also be at risk and thus should undergo genetic counseling. Screening adherence, genetic testing, and other health behaviors among individuals with FAP and their relatives are not well characterized. We conducted a cross-sectional self-report survey with individuals who have FAP (n=35) and their biological relatives (n=15). Respondents were recruited through a cancer center registry for inherited colon cancers. Most relatives had undergone colon cancer screening; 40% had undergone genetic testing. One fifth of respondents with FAP had not undergone an upper endoscopy, contrary to usual recommendations. Cigarette smoking rates were above average and were higher among FAP respondents. Use of vitamin supplements was fairly common, more so among those with FAP. Although most people had been screened, there are areas for improvement, notably for upper endoscopy among individuals with FAP and genetic testing among family members. Several other health-risk behaviors and health concerns other than FAP were identified. Further research into factors contributing to screening rates and other health behaviors in this high-risk population is warranted

Show Me My Health Plans: a study protocol of a randomized trial testing a decision support tool for the federal health insurance marketplace in Missouri

BACKGROUND: The implementation of the ACA has improved access to quality health insurance, a necessary first step to improving health outcomes. However, access must be supplemented by education to help individuals make informed choices for plans that meet their individual financial and health needs. METHODS/DESIGN: Drawing on a model of information processing and on prior research, we developed a health insurance decision support tool called Show Me My Health Plans. Developed with extensive stakeholder input, the current tool (1) simplifies information through plain language and graphics in an educational component; (2) assesses and reviews knowledge interactively to ensure comprehension of key material; (3) incorporates individual and/or family health status to personalize out-of-pocket cost estimates; (4) assesses preferences for plan features; and (5) helps individuals weigh information appropriate to their interests and needs through a summary page with “good fit” plans generated from a tailored algorithm. The current study will evaluate whether the online decision support tool improves health insurance decisions compared to a usual care condition (the healthcare.gov marketplace website). The trial will include 362 individuals (181 in each group) from rural, suburban, and urban settings within a 90 mile radius around St. Louis. Eligibility criteria includes English-speaking individuals 18–64 years old who are eligible for the ACA marketplace plans. They will be computer randomized to view the intervention or usual care condition. DISCUSSION: Presenting individuals with options that they can understand tailored to their needs and preferences could help improve decision quality. By helping individuals narrow down the complexity of health insurance plan options, decision support tools such as this one could prepare individuals to better navigate enrollment in a plan that meets their individual needs. The randomized trial was registered in clinicaltrials.gov (NCT02522624) on August 6, 2015