Ana Palacio

Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review

ABSTRACTBACKGROUNDInadequate health literacy may impair research subjects’ ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects.METHODSWe performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension.RESULTSOur search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48–64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects.CONCLUSIONSThe evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study.

Uric Acid as a Predictor of All-Cause Mortality in Heart Failure: A Meta-Analysis

Serum uric acid (SUA) is a product of xanthine oxidase (XO). Apoptosis and tissue hypoxia lead to increased purine catabolism, which, in turn, increases XO activity and subsequently SUA levels. The purpose of this study was to perform a meta-analysis to evaluate the evidence supporting SUA as a predictor of all-cause mortality in patients with heart failure (HF) and to determine the SUA cut-off for the increase in risk. A search of the MEDLINE database (1966 to March 2009) supplemented by manual searches of bibliographies of key relevant articles was performed. The authors selected all cohort studies in which SUA was measured and mortality was reported in patients with HF. The pooled relative risk (RR) with the corresponding 95% confidence interval (CI) for all-cause mortality using the fixed-effects method was calculated. The effects of SUA on all-cause mortality at different SUA cut-offs using meta-regression was evaluated. The search strategy yielded 358 studies, of which only 6 met our eligibility criteria. The studies, however, comprised 1456 evaluable patients with HF, with a median ejection fraction of 32% (range, 26%-40%). The RR of all-cause mortality was 2.13 (95% CI, 1.78-2.55) for SUA>6.5 mg/dL compared with <6.5 mg/dL SUA level. There was a linear association (P<.01) between SUA and mortality after 7 mg/dL. Uric acid is an important prognostic marker for all-cause mortality in HF. SUA levels >7 mg/dL are associated with higher all-cause mortality.

Impact of Metformin-Induced Gastrointestinal Symptoms on Quality of Life and Adherence in Patients with Type 2 Diabetes

Abstract Aims: Gastrointestinal (GI) symptoms are common in patients with type 2 diabetes mellitus (T2DM). This study assesses the impact of 1) metformin on GI symptoms and health-related quality of life (HRQoL) and 2) metformin-associated GI symptoms on medication adherence in patients with type 2 diabetes newly beginning therapy. Methods: Patients with T2DM aged ≥ 18 years starting metformin from January to June 2007 who filled their prescriptions for ≥ 3 months were identified from a health benefits company database. Via telephone, GI symptom impact was evaluated in a 360-patient sample using the validated Bowel Symptom Questionnaire and Medical Outcomes Study 36-Item Short-Form Health (SF-36) survey. Adherence was assessed using the medication possession ratio (MPR). Logistic regression adjusting for demographic and clinical covariates was used to assess the relationship between GI symptoms and MPR < 80%. Results: The most and least common GI symptoms reported were diarrhea (62.1%) and retching (21.1%), respectively. Most GI symptoms were associated with lower physical and mental HRQoL (P < 0.05). Most changes in specific HRQoL reached the minimum important difference of 3 points. Bloating, nausea, and abdominal pain were significantly associated with MPR < 80%. Adjustment for demographic, clinical, and HRQoL factors made these relationships less evident. Conclusions: Metformin-associated GI symptoms in patients with T2DM lead to lower physical and mental HRQoL, which may result in patient nonadherence or physician reluctance to optimally titrate the metformin dose.

Association between serum uric acid and atrial fibrillation: A systematic review and meta-analysis

BACKGROUND Atrial fibrillation (AF) is mediated by oxidative stress, neurohormonal activation, and inflammatory activation. Serum uric acid (SUA) is a surrogate marker of oxidative stress. Xanthine oxidase produces SUA and is upregulated by inflammation and neurohormones. OBJECTIVE To perform a meta-analysis to evaluate the evidence supporting an association between AF and SUA. METHODS We searched the MEDLINE database (1966 to 2013) supplemented by manual searches of bibliographies of key relevant articles. We selected all cross-sectional and cohort studies in which SUA was measured and AF was reported. In cross-sectional studies, we calculated the pooled standardized mean difference of SUA between those with AF and those without AF. In cohort studies, we calculated the pooled relative risk with the corresponding 95% confidence interval (CI) for incident AF by using the random effects method. RESULTS The search strategy yielded 40 studies, of which only 9 met our eligibility criteria. The 6 cross-sectional studies comprised 7930 evaluable patients with a median prevalence of heart failure of 4% (IQR 0%-100%). The standardized mean difference of SUA for those with AF was 0.42 (95% CI 0.27-0.58) compared with those without AF. The 3 cohort studies evaluated 138,306 individuals without AF. The relative risk of having AF for those with high SUA was 1.67 (95% CI 1.23-2.27) compared with those with normal SUA. CONCLUSION High SUA is associated with AF in both cross-sectional and cohort studies. It is unclear whether SUA represents a disease marker or a treatment target.

Longitudinal evaluation of health care utilization and costs during the first three years after a new diagnosis of fibromyalgia.

Abstract Objective: To evaluate health care resource utilization and costs 1 year before and 3 years after a fibromyalgia (FM) diagnosis. Methods: This retrospective cohort analysis used claims from Humana to identify newly diagnosed FM patients ≥18 years of age based on ≥2 medical claims for ICD-9 CM code 729.1 and 729.0 between June 1, 2002 and March 1, 2005. Prevalence of comorbidities, as well as utilization and costs of pharmacotherapy and health care services were examined for 12 months preceding (pre-diagnosis) and 36 months following (post-diagnosis) the date of first FM diagnosis. These periods were subdivided into 6-month blocks to better observe patterns of change. Results: We identified 2613 FM patients who had a mean age at diagnosis of 58.5 ± 15.3 years and a mean Charlson Comorbidity Index of 0.48 ± 1.05. Of those, 73% were female. The use and costs of pain-related medications rose from pre-diagnosis and remained stable after the 6-month post-diagnosis period, while the use of non-pain-related medications steadily rose from pre-diagnosis to 3 years post-diagnosis. This increase was concomitant with an increase in the presence of conditions that may account for higher resource utilization. The use of recommended FM therapies (i.e., antidepressants and anticonvulsants) increased post-diagnosis but remained less common than other pain-related therapies. Total resource utilization and costs increased during the period up to 6 months after diagnosis. This increase was followed by a decline (7–12 months post-diagnosis), and plateau, with an increase during the final 6 months of the study period. Total mean per patient costs were

The prevalence of erectile dysfunction in heart failure patients by race and ethnicity

3481 for the 6-month post-diagnosis period, and

Patient values and preferences when choosing anticoagulants.

3588 for the final 6 months. Limitations include potential errors in coding and recording, and an inability of claims analyses to determine causality between resource utilization and the specific diagnosis of interest. Conclusions: An FM diagnosis was associated with increased utilization and pain-related medication cost up to the first 6 months post-diagnosis followed by stabilization over 3 years post-diagnosis. Less use of recommended therapies relative to other therapies suggests that further dissemination of treatment guidelines is needed. An increase in non-pain medications over the observation period accounted for the majority of pharmacy costs. These pharmacy costs may be related to an increasing prevalence of comorbid conditions.

Metabolic Syndrome Increases Mortality in Heart Failure

Erectile dysfunction (ED) is a common problem in male patients with heart failure (HF). However, no study was found that estimates the prevalence of ED by US ethnic groups with HF. We conducted an observational, cross-sectional study of patients enrolled in a HF disease management program in two sites Louisiana (N=329; 178 white, 99 black) and Florida (N=52; Hispanic). All male patients with an ejection fraction ⩽40% were included. The Sexual Health Inventory for Men was used to estimate the prevalence of ED. Overall prevalence of ED was 89% and ED severity did not vary by race/ethnic group. Race/ethnic group differences were found for age, New York Heart Association functional classification, and blood pressure. Hispanic patients had the lowest unadjusted and adjusted prevalence rate of ED (81, 85%) compared to Black (90, 95%) and White (91, 92%) patients. There is a high prevalence of ED in Hispanic, Black and White ethnic groups with HF.

Inflammatory bowel disease is presenting sooner after immigration in more recent US immigrants from Cuba

Background New oral anticoagulants have similar efficacy and lower bleeding rates compared with warfarin. However, in case of bleeding there is no specific antidote to reverse their effects. We evaluated the preferences and values of anticoagulants of patients at risk of atrial fibrillation and those who have already made a decision regarding anticoagulation. Methods We conducted a cross-sectional study of Veterans in the primary care clinics and the international normalized ratio (INR) laboratory. We developed an instrument with patient and physician input to measure patient values and preferences. The survey contained a hypothetical scenario of the risk of atrial fibrillation and the attributes of each anticoagulant. After the scenario, we asked participants to choose the option that best fits their preferences. The options were: 1) has better efficacy at reducing risk of stroke; 2) has been in the market for a long period of time; 3) has an antidote to reverse the rare case of bleeding; 4) has better quality of life profile with no required frequent laboratory tests; or 5) I want to follow physician recommendations. We stratified our results by those patients who are currently exposed to anticoagulants and those who are not exposed but are at risk of atrial fibrillation. Results We approached 173 Veterans and completed 137 surveys (79% response rate). Ninety subjects were not exposed to anticoagulants, 46 reported being on warfarin, and one reported being on dabigatran at the time of the survey. Ninety-eight percent of subjects stated they would like to participate in the decision-making process of selecting an anticoagulant. Thirty-six percent of those exposed and 37% of those unexposed to anticoagulants reported that they would select a medication that has an antidote even if the risk of bleeding was very small. Twenty-three percent of the unexposed and 22% of the exposed groups reported that they would prefer the medication that gives the best quality of life. Conclusion Our study found that patients who may be exposed to an anticoagulation decision prefer to actively participate in the decision-making process, and have individual values for making a decision that cannot be predicted or assumed by anyone in the health care system.

Predictors of Scholarly Success among Internal Medicine Residents

Metabolic syndrome (MetS) is a risk factor for diabetes, cardiovascular disease, and heart failure, but little is known about the impact of MetS in patients who already have heart failure (HF).