BACKGROUNDWe sought to examine the relationship between literacy and heart failure-related quality of life (HFQOL), and to explore whether literacy-related differences in knowledge, self-efficacy and/or self-care behavior explained the relationship.METHODSWe recruited patients with symptomatic heart failure (HF) from four academic medical centers. Patients completed the short version of the Test of Functional Health Literacy in Adults (TOFHLA) and questions on HF-related knowledge, HF-related self-efficacy, and self-care behaviors. We assessed HFQOL with the Heart Failure Symptom Scale (HFSS) (range 0–100), with higher scores denoting better quality of life. We used bivariate (t-tests and chi-square) and multivariate linear regression analyses to estimate the associations between literacy and HF knowledge, self-efficacy, self-care behaviors, and HFQOL, controlling for demographic characteristics. Structural equation modeling was conducted to assess whether general HF knowledge, salt knowledge, self-care behaviors, and self-efficacy mediated the relationship between literacy and HFQOL.RESULTSWe enrolled 605 patients with mean age of 60.7 years; 52% were male; 38% were African-American and 16% Latino; 26% had less than a high school education; and 67% had annual incomes under $25,000. Overall, 37% had low literacy (marginal or inadequate on TOFHLA). Patients with adequate literacy had higher general HF knowledge than those with low literacy (mean 6.6 vs. 5.5, adjusted difference 0.63, p < 0.01), higher self-efficacy (5.0 vs. 4.1 ,adjusted difference 0.99, p < 0.01), and higher prevalence of key self-care behaviors (p < 0.001). Those with adequate literacy had better HFQOL scores compared to those with low literacy (63.9 vs. 55.4, adjusted difference 7.20, p < 0.01), but differences in knowledge, self-efficacy, and self-care did not mediate this difference in HFQOL.CONCLUSIONLow literacy was associated with worse HFQOL and lower HF-related knowledge, self-efficacy, and self-care behaviors, but differences in knowledge, self-efficacy and self-care did not explain the relationship between low literacy and worse HFQOL.
Low literacy increased the risk of hospitalization for ambulatory patients with heart failure. Interventions designed to mitigate literacy-related disparities in outcomes are warranted.
Background Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy. Methods and Results A 1-year, multisite, randomized controlled comparative effectiveness trial with 605 patients with HF. Those randomized to single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life (HFQOL) with pre-specified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio (IRR)=1.01 (95% Confidence Interval (CI): 0.83, 1.22). The effect of multisession training compared with single session training differed by literacy group: among low literacy, multisession yielded lower incidence of all-cause hospitalization and death: IRR=0.75 (0.45,1.25); and among higher literacy, multisession yielded higher incidence: IRR=1.22 (0.99,1.50) (interaction p=0.048). For HF-related hospitalization: among low literacy, multisession yielded lower incidence: IRR=0.53 (95% CI: 0.25,1.12); and among higher literacy, multisession yielded higher incidence: IRR=1.32 (95% CI: 0.92,1.88) (interaction p=0.005). HFQOL improved more for patients receiving multisession compared with single session at 1 and 6 months, but the difference at 12 months was smaller. Effects on HFQOL did not differ by literacy. Conclusions Overall, an intensive multisession intervention did not change clinical outcomes compared with a single session intervention. People with low literacy appear to benefit more from multisession than people with higher literacy. Clinical Trial Registration Information ClinicalTrials.gov; Identifier: NCT00378950.
Background The optimal strategy for promoting self-care for heart failure (HF) is unclear. Methods and Results We conducted a randomized trial to determine whether a “teach to goal” (TTG) educational and behavioral support program provided incremental benefits to a brief (one hour) educational intervention (BEI) for knowledge, self-care behaviors, and HF-related quality of life (HFQOL). The TTG program taught use of adjusted-dose diuretics and then reinforced learning goals and behaviors with 5-8 telephone counseling sessions over one month. Participants’ (N=605) mean age was 61 years; 37% had marginal or inadequate literacy; 69% had ejection fraction < 0.45; and 31% had class III or IV symptoms. The TTG group had greater improvements in general and salt knowledge (p < 0.001) and greater increases in self-care behaviors (from mean 4.8 to 7.6 for TTG vs. 5.2 to 6.7 for BEI; p<0.001). HFQOL improved from 58.5 to 64.6 for the TTG group but did not change for the BEI group (64.7 to 63.9; p < 0.001 for the difference in change scores). Improvements were similar regardless of participants’ literacy level. Conclusions Telephone reinforcement of learning goals and self-care behaviors improved knowledge, health behaviors, and HF-related QOL compared to a single education session.
Objective Develop response criteria for juvenile dermatomyositis (JDM). Methods We analyzed the performance of 312 definitions that used core set measures (CSM) from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Pediatric Rheumatology International Trials Organization (PRINTO) and were derived from natural history data and a conjoint-analysis survey. They were further validated in the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis trial. Experts considered 14 top-performing candidate criteria based on their performance characteristics and clinical face validity using nominal group technique at a consensus conference. Results Consensus was reached for a conjoint analysis–based continuous model with a Total Improvement Score of 0-100, using absolute percent change in CSM with thresholds for minimal (≥30 points), moderate (≥45), and major improvement (≥70). The same criteria were chosen for adult dermatomyositis/polymyositis with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal, 92-94% and 94-99% for moderate, and 91-98% and 85-85% for major improvement, respectively, in JDM patient cohorts using the IMACS and PRINTO CSM. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (P=0.009–0.057) and in the Rituximab trial for significantly differentiating the physician rating of improvement (P<0.006). Conclusion The response criteria for JDM was a conjoint analysis–based model using a continuous improvement score based on absolute percent change in CSM, with thresholds for minimal, moderate, and major improvement.
Background Heart failure (HF) self-care interventions can improve outcomes, but less than optimal adherence may limit their effectiveness. We evaluated if adherence to weight monitoring and diuretic self-adjustment was associated with HF-related ED visits or hospitalizations. Methods and Results We performed a case-control analysis nested in a HF self-care randomized trial. Participants received HF self-care training including weight monitoring and diuretic self-adjustment, which they were to record in a diary. We defined cases as HF-related ED visits or hospitalizations and the 7 preceding days; controls were defined as 7-day periods free of ED visits and hospitalizations. We used logistic regression to compare weight monitoring and diuretic self-adjustment adherence in cases and controls, adjusted for demographic and clinical covariates. Among 303 participants, we identified 81 HF-related ED visits or hospitalizations (cases) in 54 patients over one year of follow-up. Weight monitoring adherence (OR 0.42, 95% CI 0.23, 0.76) and diuretic self-adjustment adherence (OR 0.44, 95% CI 0.19, 0.98) were both associated with lower adjusted odds of HF-related ED visits or hospitalizations. Conclusions Adherence to weight monitoring and diuretic self-adjustment was associated with lower odds of HF-related ED visits or hospitalizations. Adherence to these activities may reduce HF-related morbidity.
Objective Develop response criteria for juvenile dermatomyositis (JDM). Methods We analyzed the performance of 312 definitions that used core set measures (CSM) from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Pediatric Rheumatology International Trials Organization (PRINTO) and were derived from natural history data and a conjoint-analysis survey. They were further validated in the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis trial. Experts considered 14 top-performing candidate criteria based on their performance characteristics and clinical face validity using nominal group technique at a consensus conference. Results Consensus was reached for a conjoint analysis–based continuous model with a Total Improvement Score of 0-100, using absolute percent change in CSM with thresholds for minimal (≥30 points), moderate (≥45), and major improvement (≥70). The same criteria were chosen for adult dermatomyositis/polymyositis with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal, 92-94% and 94-99% for moderate, and 91-98% and 85-85% for major improvement, respectively, in JDM patient cohorts using the IMACS and PRINTO CSM. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (P=0.009–0.057) and in the Rituximab trial for significantly differentiating the physician rating of improvement (P<0.006). Conclusion The response criteria for JDM was a conjoint analysis–based model using a continuous improvement score based on absolute percent change in CSM, with thresholds for minimal, moderate, and major improvement.
Objective Develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Methods Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures (CSM). Myositis experts rated greater improvement among multiple pair-wise scenarios in conjoint analysis surveys, where different levels of improvement in two CSM were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined relative weights of CSM and conjoint analysis definitions. Performance characteristics of definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using a clinical trial. Nominal group technique was used for consensus. Results Consensus was reached for a conjoint analysis–based continuous model using absolute percentage change in CSMs (physician, patient, and extra-muscular global activity, muscle strength, health assessment questionnaire and muscle enzymes). A Total Improvement Score (0–100), determined by summing scores in each CSM, was based on the improvement and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the Total Improvement Score. The same criteria were chosen for juvenile DM with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 90% and 96% for minimal, moderate, and major improvement, respectively. Definitions were validated in trial analysis for differentiating the physician rating of improvement (P<0.001). Conclusion The response criteria for adult DM/PM was the conjoint analysis model based on absolute percentage change in six CSMs, with thresholds for minimal, moderate, and major improvement.
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