Marina Serper

The Influence of Health Literacy on Comprehension of a Colonoscopy Preparation Information Leaflet

BACKGROUND: Successful bowel preparation is important for safe, efficacious, cost-effective colonoscopy procedures; however, poor preparation is common. OBJECTIVE: We sought to determine whether there was an association between health literacy and comprehension of typical written instructions on how to prepare for a colonoscopy to enable more targeted interventions in this area. DESIGN: This is a cross-sectional observational study. SETTING: This study was performed at primary care clinics and federally qualified health centers in Chicago, Illinois. PATIENTS: Seven hundred sixty-four participants (mean age, 63 years; SD, 5.42) were recruited. The sample was from a mixed sociodemographic background, and 71.9% of the participants were classified as having adequate health literacy scores. INTERVENTION: Seven hundred sixty-four participants were presented with an information leaflet outlining the bowel preparatory instructions for colonoscopy. MAIN OUTCOME MEASURES: Five questions were used to assess participants’ comprehension of the instructions in an “open book” test. RESULTS: Comprehension scores on the bowel preparation items were low. The mean number of items correctly answered was 3.2 (SD, 1.2) of a possible 5. Comprehension scores overall and for each individual item differed significantly by health literacy level (all p < 0.001). After controlling for sex, age, race, socioeconomic status, and previous colonoscopy experience in a multivariable model, health literacy was a significant predictor of comprehension (inadequate vs adequate: &bgr; = −0.2; p < 0.001; marginal vs adequate: &bgr; = −0.2; p < 0.001). LIMITATIONS: The outcome represents a simulated task and not actual comprehension of preparation instructions for participants’ own recommended behavior. CONCLUSIONS: Comprehension of a written colonoscopy preparation leaflet was generally low and significantly lower among people with low health literacy. Poor comprehension has implications for the safety and economic impact of gastroenterological procedures such as colonoscopy. Therefore, future interventions should aim to improve comprehension of complex medical information by reducing literacy-related barriers.

Factors associated with major adverse cardiovascular events after liver transplantation among a national sample

Assessment of major adverse cardiovascular events (MACE) after liver transplantation (LT) has been limited by the lack of a multicenter study with detailed clinical information. An integrated database linking information from the University HealthSystem Consortium and the Organ Procurement and Transplant Network was analyzed using multivariate Poisson regression to assess factors associated with 30‐ and 90‐day MACE after LT (February 2002 to December 2012). MACE was defined as myocardial infarction (MI), heart failure (HF), atrial fibrillation (AF), cardiac arrest, pulmonary embolism, and/or stroke. Of 32 810 recipients, MACE hospitalizations occurred in 8% and 11% of patients at 30 and 90 days, respectively. Recipients with MACE were older and more likely to have a history of nonalcoholic steatohepatitis (NASH), alcoholic cirrhosis, MI, HF, stroke, AF and pulmonary and chronic renal disease than those without MACE. In multivariable analysis, age >65 years (incidence rate ratio [IRR] 2.8, 95% confidence interval [95% CI] 1.8–4.4), alcoholic cirrhosis (IRR 1.6, 95% CI 1.2–2.2), NASH (IRR 1.6, 95% CI 1.1–2.4), pre‐LT creatinine (IRR 1.1, 95% CI 1.04–1.2), baseline AF (IRR 6.9, 95% CI 5.0–9.6) and stroke (IRR 6.3, 95% CI 1.6–25.4) were independently associated with MACE. MACE was associated with lower 1‐year survival after LT (79% vs. 88%, p < 0.0001). In a national database, MACE occurred in 11% of LT recipients and had a negative impact on survival. Pre‐LT AF and stroke substantially increase the risk of MACE, highlighting potentially high‐risk LT candidates.

Patient Factors That Affect Quality of Colonoscopy Preparation

BACKGROUND & AIMS Optimal colonoscopy preparation requires patients to adhere to written instructions and be activated to complete the task. Among patients with chronic disease, health literacy and patient activation have been associated with outcome, but these factors have not been studied for colonoscopy. We examined the association between health literacy, patient activation, and quality of bowel preparation. METHODS We analyzed outpatient colonoscopy results from 462 adults, 55-74 years old (mean, 62 ± 6 years), who previously completed extensive neurocognitive assessments as part of a prospective study (Health Literacy and Cognitive Function in Older Adults). We collected information on cecal intubation, polyp detection, bowel preparation quality, and histopathology. RESULTS One-third of the patients (n = 134) had suboptimal quality of bowel preparation; 15% (n = 62) had fair quality, and 17% (n = 72) had poor quality. Limited health literacy was associated with a lower level of education (P < .001), diabetes (P < .001), and a higher number of chronic conditions (P < .001), but not quality of colonoscopy preparation. No baseline characteristics were associated with patient activation. In multivariable analysis, after adjusting for demographics and clinical characteristics, diabetes (odds ratio [OR], 2.45; 95% confidence interval [CI], 1.14-5.25) and patient activation (OR, 2.12; 95% CI, 1.30-3.45) were independent predictors of suboptimal bowel preparation quality, but limited health literacy was not (OR, 0.76; 95% CI, 0.38-1.52). CONCLUSIONS We investigated the relationship between health literacy, patient activation, and colonoscopy preparation quality. Lower patient activation was an independent predictor of suboptimal bowel preparation quality. Interventions to improve colonoscopy preparation quality should consider the importance of patient activation within their design.

Medication misuse, nonadherence, and clinical outcomes among liver transplant recipients

Medication nonadherence after liver transplantation (LT) is associated with adverse clinical outcomes such as graft rejection and graft loss. Few studies have examined nonadherence and its impact on clinical outcomes in LT. The study objectives were (1) to evaluate medication understanding (with treatment knowledge and demonstrated regimen use scores) and medication adherence or nonadherence to entire regimens among LT recipients and (2) to examine associations of these exposures with clinical outcomes. We conducted a 2‐site study of 105 recipients between 2011 and 2012 at 2 transplant centers in Chicago, IL and Atlanta, GA. Data were collected via detailed, in‐person interviews and medical record reviews. Study participants were middle‐aged and predominantly male; 15% of the sample had limited literacy. On average, patients were taking 11 medications [standard deviation (SD) = 4], and 39% had undergone a medication change within the last month. The average scores for the entire medication regimen were 86% (SD = 22%) for treatment knowledge and 78% (SD = 22%) for demonstrated regimen use. The mean score for self‐reported nonadherence to the entire regimen was 14% (SD = 20%), whereas 32% of the patients were nonadherent according to tacrolimus levels. In multivariate analyses, lower income, less time since transplantation, a higher number of medications, and limited literacy were inversely associated with treatment knowledge scores (all P < 0.05), whereas limited literacy was associated with nonadherence according to tacrolimus levels (P < 0.05). In multivariate models, higher scores for treatment knowledge [incidence rate ratio (IRR) = 0.85, 95% confidence interval (CI) = 0.74‐0.97] and demonstrated regimen use (IRR = 0.87, 95% confidence interval = 0.77‐0.98) were independently associated with 15% and 13% reductions in the number of posttransplant rehospitalizations, respectively. Inadequate treatment knowledge and improper regimen use may be significant determinants of unintentional nonadherence among LT recipients and are associated with adverse clinical outcomes. Liver Transpl 21:22‐28, 2015.

Delta hepatitis within the Veterans Affairs medical system in the United States: Prevalence, risk factors, and outcomes

BACKGROUND & AIMS Low hepatitis delta prevalence estimates in the United States are likely biased due to low testing rates. The objectives of this study were to quantify the prevalence of testing and identify factors associated with hepatitis D positive status among chronic hepatitis B patients in the Veterans Health Administration. METHODS We performed a nationwide retrospective study of all veterans who tested positive for HBsAg from October 1999 to December 2013. Hepatitis D antibody testing results were used to stratify patients into three groups: HDV-positive, HDV-negative, and HDV-not tested. Demographics, comorbidities, additional laboratory data and clinical outcomes were compared across these groups of patients using standard statistical approaches. RESULTS Among 25,603 patients with a positive hepatitis B surface antigen, 2175 (8.5%) were tested for HDV; 73 (3.4%) patients tested positive. Receiving HDV testing was associated with receipt of testing for HBV, HIV, and HCV. Predictors of positive HDV results included substance abuse and cirrhosis. Fitting a predefined high-risk profile (abnormal ALT with suppressed HBV DNA titers) was strongly associated with testing positive for HDV (OR 3.2, 95%CI 1.4-7.5). Most (59%) of HDV-positive patients were HCV co-infected. HDV-positive subjects had higher risks of all-cause mortality. Incidence rates of HCC were 2.9 fold higher in HDV-positive relative to HDV-negative individuals (p=0.002). In adjusted analyses, HDV was independently associated with HCC (OR 2.1, 95%CI 1.1-3.9). CONCLUSIONS Testing rates for hepatitis delta in chronic hepatitis B patients in the United States are inappropriately low. Approaches to increase testing for HDV particularly in high-risk subsets should be explored.

Comparative effectiveness of patient-centered strategies to improve FDA medication guides.

Background:Med Guides are the only Food and Drug Administration-regulated source of written patient information distributed with prescriptions drugs. Despite their potential value, studies have found them to have limited utility. Objective:To evaluate the effectiveness of patient-centered strategies for the design of Med Guides to improve comprehension. Design:A cross-sectional, randomized trial. Setting:Two primary care clinics in Chicago, Illinois; one based in a public university hospital and the other within a private academic medical center. Patients:A total of 1003 adults aged 18–85 years. Intervention:The format and layout of content from 3 typical Med Guides (by reading difficulty, length, exposure) were modified several ways to promote information accessibility. Working with patients, the 3 most preferred versions were evaluated. The first used 2 columns to organize content (Column), a second mimicked over-the-counter “Drug Facts” labeling (Drug Facts), and the third followed health literacy best practices using a simple table format (Health Literacy prototype). Measures:Tailored comprehension assessment of content from 3 representative Med Guides. Results:Comprehension was significantly greater for all 3 prototypes compared with the current standard (all P<0.001). The Health Literacy prototype consistently demonstrated the highest comprehension scores, and in multivariable analyses, outperformed both the Drug Facts [&bgr;=−4.43, 95% confidence interval (CI), −6.21 to −2.66] and Column (&bgr;=−4.04, 95% CI, −5.82 to −2.26) prototypes. Both older age (older than 60 y: &bgr;=−10.54, 95% CI, −15.12 to −5.96), low and marginal literacy skills were independently associated with poorer comprehension (low: &bgr;=−31.92, 95% CI, −35.72 to −28.12; marginal: &bgr;=−12.91, 95% CI, −16.01 to −9.82). Conclusions:The application of evidence-based practices to the redesign of Med Guides significantly improved patient comprehension. Although some age and literacy disparities were reduced with the Health Literacy format in particular, both older age and low literacy remained independently associated with poorer comprehension. More aggressive strategies will likely be needed to gain assurances that all patients are informed about their prescribed medications. Trial Registration:Clinical Trials.Gov #NCT01731405.

Identifying barriers to hepatocellular carcinoma surveillance in a national sample of patients with cirrhosis

Hepatocellular carcinoma (HCC) is a leading cause of morbidity and mortality in cirrhosis patients. This provides an opportunity to target the highest‐risk population, yet surveillance rates in the United States and Europe range from 10% to 40%. The goal of this study was to identify barriers to HCC surveillance, using data from the Veterans Health Administration, the largest provider of liver‐related health care in the United States. We included all patients 75 years of age or younger who were diagnosed with cirrhosis from January 1, 2008, until December 31, 2010. The primary outcome was a continuous measure of the percentage of time up‐to‐date with HCC surveillance (PTUDS) based on abdominal ultrasound (secondary outcomes included computed tomography and magnetic resonance imaging). Among 26,577 patients with cirrhosis (median follow‐up = 4.7 years), the mean PTUDS was 17.8 ± 21.5% (ultrasounds) and 23.3 ± 24.1% when any liver imaging modality was included. The strongest predictor of increased PTUDS was the number of visits to a specialist (gastroenterologist/hepatologist and/or infectious diseases) in the first year after cirrhosis diagnosis; the association between visits to a primary care physician and increasing surveillance was very small. Increasing distance to the closest Veterans Administration center was associated with decreased PTUDS. There was an inverse association between ultrasound lead time (difference between the date an ultrasound was ordered and requested exam date) and the odds of it being performed: odds ratio = 0.77, 95% confidence interval 0.72‐0.82 when ordered > 180 days ahead of time; odds ratio = 0.90, 95% confidence interval 0.85‐0.94 if lead time 91‐180 days. Conclusions: The responsibility for suboptimal surveillance rests with patients, providers, and the overall health care system; several measures can be implemented to potentially increase HCC surveillance, including increasing patient–specialist visits and minimizing appointment lead time. (Hepatology 2017;65:864‐874).

Care delivery and outcomes among US veterans with hepatitis B: A national cohort study.

Previous studies have identified gaps in hepatitis B care. The objectives of this study were to evaluate the delivery of care among a national cohort of US veterans with chronic hepatitis B infection and examine risk factors for adverse clinical outcomes. We conducted a retrospective cohort study using the Veterans Health Administration Corporate Data Warehouse from 1999 to 2013 to evaluate (1) care delivery and (2) clinical outcomes such as hepatocellular carcinoma, hepatic decompensation, and mortality among US veterans with hepatitis B. Incidence rates with 95% confidence intervals were calculated and Cox regression models were used to evaluate clinical outcomes. We identified 21,419 veterans with a positive hepatitis B surface antigen, and 97% of patients had alanine aminotransferase and 44% had hepatitis B virus DNA testing; hepatitis B e antigen and hepatitis B e antibody were tested <50% of the time. Patients receiving specialty care had a higher prevalence of recommended laboratory testing. Patients with elevated alanine aminotransferase in specialty care were more likely to receive antiviral therapy (50% versus 24% for specialty care versus no specialty care, P < 0.001). Among patients with cirrhosis, 69% received one‐time liver imaging. The proportion of follow‐up time adherent to annual imaging was 0.39 (standard deviation = 0.42), and the proportion was 0.28 (standard deviation = 0.33) for biannual imaging; both proportions were higher in the specialty care group (all P < 0.05). Antiviral therapy (hazard ratio = 0.85, 95% confidence interval 0.76‐0.95, P = 0.005) and liver imaging (hazard ratio = 0.84, 95% confidence interval 0.76‐0.91, P < 0.001) were independently associated with decreased mortality in adjusted analyses. Conclusion: We observed a low prevalence of recommended laboratory testing, antiviral therapy initiation, and liver imaging among a national cohort of veterans with hepatitis B infection; antiviral therapy and liver imaging were independently associated with decreased mortality. (Hepatology 2016;63:1774‐1782)

Risk factors, clinical presentation, and outcomes in overdose with acetaminophen alone or with combination products: results from the Acute Liver Failure Study Group

Background and Aims: Acetaminophen (APAP) is the most common cause of acute liver failure (ALF) in the west. It is unknown if APAP overdose in combination with diphenhydramine or opioids confers a different clinical presentation or prognosis. Study objectives were to compare (1) baseline patient characteristics; (2) initial clinical presentation; and (3) clinical outcomes among patients with ALF due to APAP alone or in combination with diphenhydramine or opioids. Methods: We analyzed 666 cases of APAP-related liver failure using the Acute Liver Failure Study Group database from 1998 to 2012. The database contains detailed demographic, laboratory, and clinical outcome data, including hemodialysis, transplantation, and death and in-hospital complications such as arrhythmia and infection. Results: The final sample included 666 patients with APAP liver injury. A total 30.3% of patients were overdosed with APAP alone, 14.1% with APAP/diphenhydramine, and 56.6% with APAP/opioids. Patients taking APAP with opioids were older, had more comorbidities, and were more likely to have unintentional overdose (all P<0.0001). On presentation, 58% in the APAP/opioid group had advanced encephalopathy as compared with 43% with APAP alone (P=0.001) The APAP/diphenhydramine group presented with the highest serum aminotransferase levels, no differences in laboratory values were noted at 3 days postenrollment. No significant differences were observed in clinical outcomes among the groups. Conclusions: Most patients with APAP-induced ALF were taking APAP combination products. There were significant differences in patient characteristics and clinical presentation based on the type of product ingested, however, there were no differences noted in delayed hepatotoxicity or clinical outcomes.

Medication understanding, non-adherence, and clinical outcomes among adult kidney transplant recipients.

We sought to evaluate the prevalence of medication understanding and non‐adherence of entire drug regimens among kidney transplantation (KT) recipients and to examine associations of these exposures with clinical outcomes. Structured, in‐person interviews were conducted with 99 adult KT recipients between 2011 and 2012 at two transplant centers in Chicago, IL; and Atlanta, GA. Nearly, one‐quarter (24%) of participants had limited literacy as measured by the Rapid Estimate of Adult Literacy in Medicine test; patients took a mean of 10 (SD=4) medications and 32% had a medication change within the last month. On average, patients knew what 91% of their medications were for (self‐report) and demonstrated proper dosing (via observed demonstration) for 83% of medications. Overall, 35% were non‐adherent based on either self‐report or tacrolimus level. In multivariable analyses, fewer months since transplant and limited literacy were associated with non‐adherence (all P<.05). Patients with minority race, a higher number of medications, and mild cognitive impairment had significantly lower treatment knowledge scores. Non‐white race and lower income were associated with higher rates of hospitalization within a year following the interview. The identification of factors that predispose KT recipients to medication misunderstanding, non‐adherence, and hospitalization could help target appropriate self‐care interventions.