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BACKGROUND: A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients’ physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. METHODS: Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. RESULTS: Participants’ (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p CONCLUSIONS: The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life. REGISTRATION: URL: https://clinicaltrials.gov ; Unique: identifier: NCT03044535.

Background Patient–physician communication during clinical encounters is essential to ensure quality of care. Many studies have attempted to improve patient–physician communication. Incorporating patient priorities into agenda setting and medical decision-making are fundamental to patient-centered communication. Efficient and scalable approaches are needed to empower patients to speak up and prepare physicians to respond. Leveraging electronic health records (EHRs) in engaging patients and health care teams has the potential to enhance the integration of patient priorities in clinical encounters. A systematic approach to eliciting and documenting patient priorities before encounters could facilitate effective communication in such encounters. Objective In this paper, we report the design and implementation of a set of EHR tools built into clinical workflows for facilitating patient–physician joint agenda setting and the documentation of patient concerns in the EHRs for ambulatory encounters. Methods We engaged health information technology leaders and users in three health care systems for developing and implementing a set of EHR tools. The goal of these tools is to standardize the elicitation of patient priorities by using a previsit “patient important issue” questionnaire distributed through the patient portal to the EHR. We built additional EHR documentation tools to facilitate patient–staff communication when the staff records the vital signs and the reason for the visit in the EHR while in the examination room, with a simple transmission method for physicians to incorporate patient concerns in EHR notes. Results The study is ongoing. The anticipated completion date for survey data collection is November 2021. A total of 34,037 primary care patients from three health systems (n=26,441; n=5136; and n=2460 separately recruited from each system) used the previsit patient important issue questionnaire in 2020. The adoption of the digital previsit questionnaire during the COVID-19 pandemic was much higher in one health care system because it expanded the use of the questionnaire from physicians participating in trials to all primary care providers midway through the year. It also required the use of this previsit questionnaire for eCheck-ins, which are required for telehealth encounters. Physicians and staff suggested anecdotally that this questionnaire helped patient–clinician communication, particularly during the COVID-19 pandemic. Conclusions EHR tools have the potential to facilitate the integration of patient priorities into agenda setting and documentation in real-world primary care practices. Early results suggest the feasibility and acceptability of such digital tools in three health systems. EHR tools can support patient engagement and clinicians’ work during in-person and telehealth visits. They could potentially exert a sustained influence on patient and clinician communication behaviors in contrast to prior ad hoc educational efforts targeting patients or clinicians. Trial Registration ClinicalTrials.gov NCT03385512; https://clinicaltrials.gov/ct2/show/NCT03385512 International Registered Report Identifier (IRRID) DERR1-10.2196/30431

Prognostic factors for melanoma include Breslow depth (BD), ulceration, and dermal mitotic rate (DMR). No studies have queried the effect of epidermal mitotic density (EMD) or atypical mitotic figure density (AMD) in an outcome-based assessment. Our objective was to determine if there is a relationship between EMD, AMD, BD, DMR, and ulceration and patient outcomes. This was a retrospective cohort study of 185 cases of thick and thin melanomas. Univariate and multivariate cause-specific regression analysis was performed. There was a positive correlation between EMD and BD ( P = .0001). The difference between AMD in thick and thin melanomas was statistically significant. For every unit increase in EMD, patients had a 2.8-fold increase in the risk of distant metastasis; however, statistical significance was lost in the multivariate analysis. In adjusted analyses, ulceration, DMR, and BD were associated with outcomes. There were no statistically significant correlations between AMD and outcomes. This study is limited by its small sample size, diminution of the epidermis in some thick melanomas preventing EMD estimates, and reproducibility of mitotic figure counting. EMD and AMD do not seem to have any independent value in multivariate analyses for melanoma. Ulceration, BD, and DMR were significantly associated with outcomes and further solidify these known predictors of prognosis.

Introduction: Improvement in social functioning is an important goal for advanced heart failure (HF) patients (pts) who receive left ventricular assist devices (LVADs). Self-reported social functioning and its association with clinical change is understudied. Methods: Adult HF pts who received LVADs at nine U.S. sites completed two measures of social functioning prior to, and 3-6 months after, surgery. Patient-Reported Outcomes Measurement Information System (PROMIS) measures were: Ability to Participate in Social Roles and Activities (Ability) and Satisfaction with Social Roles and Activities (Satisfaction). PROMIS uses T-scores standardized to a U.S. general population (mean=50; standard deviation, SD=10); higher scores represent better outcomes. New York Heart Association (NYHA) Functional Classification was assigned at both times by treating clinicians; change was subsequently categorized as Better, Same or Worse NYHA. Linear mixed effects models and least-squares means were estimated for Ability and Satisfaction. Results: Pts ( n =107) were primarily male (78%) and non-Hispanic White (68%); mean age (SD)=54 (12.5) years; 74% were NYHA Class IV prior to surgery and only 18% were NYHA IV at follow-up. NYHA was better for the majority ( n =75, 70%); 24% ( n =26) were the same, and 6% ( n =6) were worse. Mean Ability and Satisfaction were lower than the general population mean of 50 at both time points (Figure). Ability improved for the NYHA Better ( p p =0.030) groups, and nominally decreased for the Worse group ( p =0.800). Satisfaction improved for the Better ( p p >0.300). Conclusions: Self-reported social functioning measures were responsive to clinician-rated clinical change. Understanding these relationships may guide clinicians in providing targeted health-related quality of life therapies to improve social functioning.

Purpose To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) generic measures of social and physical function in patients with a left ventricular assist device (LVAD). Methods Adult heart failure (HF) patients at 12 U.S. sites in 2016-2020 enrolled in The Mechanical Circulatory Support: Measures of Adjustment and Quality Of Life Study (n=361). Post-LVAD implant, they completed PROMIS Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, and Physical Function; and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Social and Physical Limitation measures. PROMIS is standardized to a general population (mean=50; SD=10). KCCQ-12 range is 0-100. Higher scores represent better outcomes. Construct validity was evaluated by Pearson correlations between PROMIS and KCCQ-12 scores. Known-groups validity was evaluated by analysis of variance to distinguish PROMIS means across NYHA and self-reported financial difficulties. Results Mean age was 58 years; 80% were male, 70% were Non-Hispanic White, 79% had financial difficulties due to condition/treatment, and 61% were NYHA I-II. Similar numbers enrolled at 3, 6, 12-26, and > 26 months post-implant. Mean scores for PROMIS and KCCQ-12 measures decreased (worsened) as NYHA worsened (p Conclusion PROMIS measures of social and physical function were associated with well-accepted measures commonly assessed in HF and post-LVAD. Unlike condition-specific measures, PROMIS scores can be compared to the general population or other clinical conditions, thus providing a useful way to interpret social and physical function after LVAD implant.

Objectives Patient satisfaction with having a left ventricular assist device (LVAD) as a bridge to transplantation (BTT) or destination therapy (DT) may change over time early after surgery, as patients adjust to life on a device. We examined satisfaction at 2 time points early after surgery. Methods We evaluated patient self-report data at 3 and 6 months (mos) post implant at 12 U.S. sites (2016-2020). Measures included Satisfaction with Treatment (10 items, [FACIT-TS-G, modified]), VAD Team Communication (6 items, 0 [worst] - 18 [best] communication as wanted, [FACIT-TS-PS, modified]), and Being Bothered by VAD Self-care and Limitations (17 items, 1 [not] - 5 [very much] bothered, [new items]). Bowker's symmetry test was used to compare change in satisfaction for the 10 satisfaction items. Mixed effects models were estimated to assess change in VAD team communication and bother, assuming a missing at random mechanism. Results Patients (n=115) were primarily male (77%) and non-Hispanic White (65%); mean age(SD)=55 ( 12.5) years; 50% had an implant strategy of DT. Overall, no differences were detected regarding satisfaction with having a VAD between 3 and 6 mos after implant. 61% of patients (n=71) were satisfied (for the most part or completely) at 3 mos; of these, 63 (89%) responded similarly at 6 mos. Satisfaction with VAD team communication was high (least-squares means at 3 and 6 mos: 12.3 and 12.8) and being bothered by VAD self-care and limitations was low to moderate (least-squares means at 3 and 6 mos: 2.3 and 2.4), with no change over time (p>0.40). BTT and DT patients reported similar bother (p=0.21), but BTT patient satisfaction with communication was marginally higher than DT patients (p=0.05). Conclusions Patients were quite satisfied with having a VAD early after implant. Patients were also satisfied with communication from the VAD team and reported moderate or fewer hassles with having a VAD, which did not differ by implant strategy. Understanding satisfaction with a VAD may guide patient support early post implant.

Purpose Patients with an LVAD face unique burdens in LVAD self-care (device management) in addition to heart failure (HF) self-care (diet, exercise, medications). We evaluated the impact of health literacy and social support on self-efficacy regarding self-care, and evaluated change in self-efficacy. Methods Patients at 9 centers enrolled in the study within 30 days prior to LVAD implantation. Assessments were at baseline and 3 and 6 months post-LVAD. Self-efficacy regarding HF self-care (13 items) and Self-efficacy regarding VAD self-care (12 items) used a 4-point scale: 1=not sure at all, 4=very sure of performing self-care activities. Health Literacy Assessment Using Talking Touchscreen Technology (10 items) was dichotomized as inadequate/low vs. adequate/high. Social support (emotional, instrumental, informational) was measured with PROMIS v2.0 (T-score of 50=general population mean). Participants who died, were transplanted, or were withdrawn before 6 months were excluded from analysis. Linear mixed effects models were estimated using all available longitudinal data, assuming a missing at random mechanism. Results The sample (n=126) was primarily male (72%), non-Hispanic White (62%) and had high health literacy (67%); mean (SD) age was 55 (11.7) years. Excluded participants (n=68) were similar on most variables (p>0.05). Emotional, instrumental and informational social support were substantially higher than the general population (mean (SD): 58 (7.6), 61 (6.4), 59 (8.7)) and positively associated with HF self-care efficacy and LVAD self-care efficacy (parameter estimates: 0.01-0.02; p 0.05). Self-efficacy regarding HF self-care and VAD self-care were high and did not change over time (p>0.05): least-squares means (adjusted for social support and health literacy) at all assessments were 3.7 to 3.9. Conclusion Social support was high and positively associated with higher self-efficacy regarding HF and VAD self-care. Strong social support might mitigate the impact of other risk factors, including low health literacy, on self-efficacy. More research is needed to understand these factors in a more diverse patient group.

Purpose Patients (pts) with advanced heart failure (HF) describe debilitating HF-related symptoms. Those who undergo left ventricular assist device (LVAD) implantation report new surgical and device-related symptoms. We sought to quantify change in both HF and LVAD-related symptoms over time. Methods Using a longitudinal design, we evaluated data at baseline, 3, and 6 months (mos) post implant at 9 U.S. sites from 10/26/16 - 9/9/19. Measures assessed HF symptoms: fatigue (PROMIS, v1.0), dyspnea (10-item short form), swelling in extremities, abdominal bloating, poor appetite (single items), and LVAD-related symptoms: severity of pain at driveline exit site and chest incision, severity of discomfort wearing LVAD peripherals, and frequency of dizziness and fluid leaking around driveline exit site (single items). Linear mixed effects models were estimated using all available longitudinal data, assuming a missing at random mechanism. Results Pts (n=126) were primarily male (72%) and non-Hispanic White (62%), with mean age= 55±11.7 years. HF symptoms (i.e., fatigue, dyspnea, extremity swelling, abdominal bloating, and poor appetite) decreased from before to after implant (table). From 3-6 months after LVAD implant, severity of driveline exit site pain was none-mild and did not change; severity of chest incision pain was mild and decreased from 3 to 6 months; discomfort wearing peripherals was mild-moderate with no change, dizziness occurred rarely to occasionally and did not change, and fluid leaking at the driveline exit site occurred never to rarely and did not change (table). Conclusion Using novel measures, pts with advanced HF experienced considerable improvement of HF symptoms after LVAD implant. However, pts also reported mild/moderate discomfort wearing LVAD-related peripherals, which did not change over time. Other LVAD-related symptoms were less frequent or no more than mild in severity. These findings provide important information for pt decision making and should guide device design.

Introduction Social health (i.e., ability and satisfaction with ability to participate in family, work, and leisure activities) among patients (pts) with advanced heart failure (HF) who undergo left ventricular assist device (LVAD) implantation is incompletely described. This report evaluated social health across three time periods (early, mid, and later) after implantation. Methods We evaluated data from 183 pts with LVADs who were ≤6 months, >6-24 months, and >24 months post-implant at 9 U.S. sites (10/26/16 - 12/31/18). Measures of social health included overall social health and satisfaction with social function (PROMIS v1.1) and multi-item measures of social function and satisfaction with social function (PROMIS v2.0). Tests for differences between implant groups included χ2 tests and ANOVAs. Results Pts at all 3 time periods were, on average, middle-aged; the majority were male, white, and well educated. Etiology of HF and pre-implant strategy were similar among groups. The majority of pts at all 3 time periods reported good to excellent overall ability to carry out usual social activities and roles, and satisfaction with social activities and relationships. Approximately 20% to 30% of patients in all 3 groups reported fair or poor overall social function/ability, and fair or poor satisfaction with social activities and relationships. For all 3 groups, ability to participate in social roles and activities, and satisfaction with social roles and activities approximated the U.S. general population mean of 50. Conclusions Regardless of time since implant, the majority of LVAD pts were able to participate in social activities and were satisfied with their social health. For the subset of patients who reported lower social functioning and satisfaction, future work should focus on developing effective interventions. These findings highlight the importance of assessing social health after LVAD implantation.

Purpose Physical health among patients (pts) with advanced heart failure (HF) who undergo continuous flow left ventricular assist device (CF-LVAD) implantation is incompletely described, especially long-term. Research is needed to identify pts at risk. This report compared physical health early (≤ 6 months), mid (>6-24 months), and later (> 24 months) after CF-LVAD implantation. Methods Using a cross-sectional design, we evaluated data from 250 pts with CF-LVADs who were ≥ 3 months post implant at 9 U.S. sites from 10/26/16 - 06/28/18. Measures of physical health included overall physical health (PROMIS, v1.1), physical function (PROMIS, v1.2), sleep disturbance (PROMIS, v1.0), sleep-related impairment (PROMIS, v1.0), and satisfaction with sexual function (PROMIS, v2.0, modified). Analyses included χ2 tests and ANOVAs. Results The majority of pts were male, white, and well educated; age differed by time period post implant. Etiology of HF and pre implant strategy were similar among groups. The majority of pts in all 3 groups reported fair to good overall physical health, although significant differences were detected by group. For all 3 groups, sleep disturbance and sleep-related impairment scores approximated the U.S. general population mean of 50, while physical function scores were about one standard deviation lower. A majority of pts in all groups were not satisfied with sexual function, and most reported that LVAD equipment affected their satisfaction adversely. See table. Conclusion Regardless of time since implant, while the majority of pts reported overall physical health as fair or good, self-reported physical function was lower than the U.S. population and LVAD equipment interfered with satisfaction with sexual function. These findings highlight the importance of assessing multiple indicators of physical health and may provide direction for physical health focused therapies after CF-LVAD implantation.

Background Major depressive disorder is a common psychological problem affecting up to 20% of adults in their lifetime. The majority of people treated for depression receive antidepressant medication through their primary care physician. This commonly results in low rates of recovery. Failure points in the process of care contributing to poor outcomes include patient non-adherence to medications, failure of physicians to optimize dose and absence of communication between patients and physicians. Objective This pilot study evaluated the feasibility of a systemic digital intervention (MedLink) designed to address failure points and improve treatment of depression in primary care among patients during the first eight weeks of initiating a new course of antidepressant therapy. Methods Participants were provided with the MedLink mobile app that provided dose reminders, information and surveys of symptoms and side effects. A cellularly enabled pillbox monitored antidepressant medication adherence. Reports were provided to physicians and participants to prompt changes in medication regimen. Study outcomes were assessed via self-report and interview measures at baseline, week 4 and week 8. Results Medication adherence detected by the MedLink system was 82%. Participants demonstrated significant decreases in depressive symptoms on the patient health questionnaire-9 (PHQ-9) ( p = 0.0005) and the Quick Inventory of Depressive Symptomatology ( p = 0.0008) over the eight-week trial. Usability was generally rated favorably. Conclusions The MedLink system demonstrated promise as an intervention to address failure points in the primary care treatment of major depressive disorder. Current findings support the further development of MedLink through a randomized controlled trial to evaluate the efficacy of improving processes of care, patient adherence and symptoms of depression.

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 was conducted. Those randomized to a 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, with prespecified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio, 1.01; 95% confidence interval, 0.83–1.22). The effect of multisession training compared with single-session training differed by literacy group: Among those with low literacy, the multisession training yielded a lower incidence of all-cause hospitalization and death (incidence rate ratio, 0.75; 95% confidence interval, 0.45–1.25), and among those with higher literacy, the multisession intervention yielded a higher incidence (incidence rate ratio, 1.22; 95% confidence interval, 0.99–1.50; interaction P =0.048). For HF-related hospitalization, among those with low literacy, multisession training yielded a lower incidence (incidence rate ratio, 0.53; 95% confidence interval, 0.25–1.12), and among those with higher literacy, it yielded a higher incidence (incidence rate ratio, 1.32; 95% confidence interval, 0.92–1.88; interaction P =0.005). HF-related quality of life improved more for patients receiving multisession than for those receiving single-session interventions at 1 and 6 months, but the difference at 12 months was smaller. Effects on HF-related quality of life 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 interventions than people with higher literacy. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00378950.

Many national surveys have found substantial differences in self-reported overall health between Spanish-speaking Hispanics and other racial/ethnic groups. However, because cultural and language differences may create measurement bias, it is unclear whether observed differences in self-reported overall health reflect true differences in health.This study uses a cross-sectional survey to investigate psychometric properties of the Short Form-36v2 for subjects across 4 racial/ethnic and language groups. Multigroup latent variable modeling was used to test increasingly stringent criteria for measurement equivalence.Our sample (N=1281) included 383 non-Hispanic whites, 368 non-Hispanic blacks, 206 Hispanics interviewed in English, and 324 Hispanics interviewed in Spanish recruited from outpatient medical clinics in 2 large urban areas.We found weak factorial invariance across the 4 groups. However, there was no evidence for strong factorial invariance. The overall fit of the model was substantially worse (change in Comparative Fit Index0.02, root mean square error of approximation change0.003) after requiring equal intercepts across all groups. Further comparisons established that the equality constraints on the intercepts for Spanish-speaking Hispanics were responsible for the decrement to model fit.Observed differences between SF-36v2 scores for Spanish-speaking Hispanics are systematically biased relative to the other 3 groups. The lack of strong invariance suggests the need for caution when comparing SF-36v2 mean scores of Spanish-speaking Hispanics with those of other groups. However, measurement equivalence testing for this study supports correlational or multivariate latent variable analyses of SF-36v2 responses across all the 4 subgroups, as these analyses require only weak factorial invariance.

BACKGROUND We 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. METHODS We 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. RESULTS We 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

ObjectiveChronic obstructive pulmonary disease (COPD) is a progressive disease with functional decline leading to disability. Dyspnea, the prominent symptom, can be measured using existing measures, but a lack of consensus about standardization of dyspnea measurement remains. We examined the psychometric performance of two item-response theory–based (IRT) measures of dyspnea and related functional limitations (FLs) in patients with COPD and simulated computerized adaptive testing (CAT) of the banks to determine the number of questions required to achieve high precision.MethodsA total of 102 patients completed banks measuring dyspnea and FLs (33 items), from which the 10-item dyspnea and FL short forms were scored as well as other self-report measures of respiratory and physical function and emotional distress. A subset of patients completed the banks 7 to 10 days later. Pulmonary function test results were obtained from medical charts.ResultsThe 33-item banks and 10-item short forms had excellent internal consistency (alphas >0.9) and test-retest reliability (intraclass correlation coefficients >0.89). Patients sorted by severity level on the Medical Research Council scale were differentiated by item banks (P < 0.001) and the short forms (P < 0.01). The banks and short forms were also associated with related measures of dyspnea (e.g., Baseline Dyspnea Index, r = 0.47–0.53), physical function (e.g., 36-Item Short Form Health Survey, r = −0.83 to −0.86) and forced expiratory volume in 1 second (r = −0.32 to −0.35). On average, CAT required 4 and 5 items for accurate measurement of dyspnea and FLs, respectively.ConclusionThe Functional Assessment of Chronic Illness Therapy–Dyspnea short forms and banks provide options for brief, psychometrically sound measures of dyspnea and/or FLs in COPD.

To examine the association between depressive symptoms and exercise capacity, we performed a cross-sectional study of 944 outpatients with stable coronary artery disease and found that the presence of depressive symptoms was independently associated with poor exercise capacity (

Objectives This study was designed to determine the association between race and atrial fibrillation (AF) among patients with heart failure (HF). Background Atrial fibrillation is known to complicate HF, but whether its prevalence varies by race, and the reasons why, are not well understood. Methods We identified adults hospitalized with confirmed HF within a large integrated healthcare delivery system. We obtained information on demographics, comorbidity, vital signs, medications, and left ventricular systolic function status. “Atrial fibrillation” was defined as AF or atrial flutter documented by electrocardiogram or prior physician-assigned diagnoses. We evaluated the independent relationship between race and AF using multivariable logistic regression. Results Among 1,373 HF patients (223 African Americans, 1,150 Caucasians), the prevalence of AF was 36.9% (95% confidence interval [CI] 34.3% to 39.5%). Compared with Caucasians, African Americans were younger (mean age 67 vs. 74 years, p Conclusions In a contemporary HF cohort, AF was significantly less common among African Americans than among Caucasians. This variation was not explained by differences in traditional risk factors for AF, HF etiology and severity, and treatment.

Aims and objectivesTo determine whether a single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure.BackgroundPoor medication adherence is associated with increased morbidity and mortality. Having a simple means of identifying suboptimal medication adherence could help identify at-risk patients for interventions.DesignWe performed a prospective cohort study in 592 participants with heart failure within a four-site randomised trial.MethodsSelf-report medication adherence was assessed at baseline using a single-item question: 'Over the past seven days, how many times did you miss a dose of any of your heart medication?' Participants who reported no missing doses were defined as fully adherent, and those missing more than one dose were considered less than fully adherent. The primary outcome was combined all-cause hospitalisation or death over one year and the secondary endpoint was heart failure hospitalisation. Outcomes were assessed with blinded chart reviews, and heart failure outcomes were determined by a blinded adjudication committee. We used negative binomial regression to examine the relationship between medication adherence and outcomes.ResultsFifty-two percent of participants were 52% male, mean age was 61years, and 31% were of New York Heart Association class III/IV at enrolment; 72% of participants reported full adherence to their heart medicine at baseline. Participants with full medication adherence had a lower rate of all-cause hospitalisation and death (0·71events/year) compared with those with any nonadherence (0·86events/year): adjusted-for-site incidence rate ratio was 0·83, fully adjusted incidence rate ratio 0·68. Incidence rate ratios were similar for heart failure hospitalisations.ConclusionA single medication adherence question at baseline predicts hospitalisation and death over one year in heart failure patients.Relevance to clinical practiceMedication adherence is associated with all-cause and heart failure-related hospitalisation and death in heart failure. It is important for clinicians to assess patients' medication adherence on a regular basis at their clinical follow-ups.

BackgroundLow literacy increases the risk for many adverse health outcomes, but the relationship between literacy and adverse outcomes in heart failure (HF) has not been well studied.MethodsWe studied a cohort of ambulatory patients with symptomatic HF (NYHA Class II-IV within the past 6months) who were enrolled in a randomized controlled trial of self-care training recruited from internal medicine and cardiology clinics at four academic medical centers in the US. The primary outcome was combined all-cause hospitalization or death, with a secondary outcome of hospitalization for HF. Outcomes were assessed through blinded interviews and subsequent chart reviews, with adjudication of cause by a panel of masked assessors. Literacy was measured using the short Test of Functional Health Literacy in Adults. We used negative binomial regression to examine whether the incidence of the primary and secondary outcomes differed according to literacy.ResultsOf the 595 study participants, 37% had low literacy. Mean age was 61, 31% were NYHA class III/IV at baseline, 16% were Latino, and 38% were African-American. Those with low literacy were older, had a higher NYHA class, and were more likely to be Latino (all p

Electron paramagnetic resonance spectroscopy at 139.5 GHz has been used to study p21 ras complexed with Mn(II) and guanosine 5'-(beta, gamma-imidotriphosphate), an analog of GTP. The p21 sample studied was selectively labeled with [17O gamma]threonine to a final enrichment of 30%. A Mn(II)-17O hyperfine interaction was observed, but the value of the coupling constant, 0.11 +/- 0.04 mT, is the smallest such value yet reported. Ab initio calculations indicate that this value is consistent with direct coordination of the threonine hydroxyl group and provide an estimate for the Mn(II)-17O bond length of 2.7 A. The measured hyperfine coupling constant and associated bond length starkly contrast with typical values for Mn(II)-17O coordination complexes, namely, approximately 0.25 mT and approximately 2.2 A, respectively. This contrast underscores the peculiar weakness of this Mn(II)-O interaction in p21 and persuasively argues that the nucleotide-induced conformational change, which is known to encompass the region of p21 involving Thr35, is not driven by Mn(II) coordination of the Thr35 hydroxyl group.

Self-management is vital for achieving optimal health outcomes for patients with heart failure (HF). We sought to develop an intervention to improve self-management skills and behaviors for patients with HF, especially those with low health literacy. Individuals with low health literacy have difficulty reading and understanding written information and comprehending numerical information and performing calculations, and they tend to have worse baseline knowledge, short-term memory, and working memory compared to individuals with higher health literacy. This paper describes theoretical models that suggest methods to improve the design of educational curricula and programs for low literate audiences, including cognitive load theory and learning mastery theory. We also outline the practical guiding principles for designing our intervention, which includes a multi-session educational strategy that teaches patients self-care skills until they reach behavioral goals (“Teach to Goal”). Ourintervention strategy is being tested in a randomized controlled trial to determine if it is superior to a single-session brief educational intervention for reducing hospitalization and death. If this trial shows that the “Teach to Goal” approach is superior, this would support the value of incorporating these design principles into educational interventions for other diseases.

The optimal strategy for promoting self-care for heart failure (HF) is unclear.We conducted a randomized trial to determine whether a "teach to goal" (TTG) educational and behavioral support program provided incremental benefits to a brief (1 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 to 8 telephone counseling sessions over 1 month. Participants' (n = 605) mean age was 61 years; 37% had marginal or inadequate literacy; 69% had ejection fraction0.45; and 31% had Class III or IV symptoms. The TTG group had greater improvements in general and salt knowledge (P.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.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.001 for the difference in change scores). Improvements were similar regardless of participants' literacy level.Telephone reinforcement of learning goals and self-care behaviors improved knowledge, health behaviors, and HF-related QOL compared to a single education session.

To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared with typical instructions.A total of 500 adult patients recruited from 2 academic and 2 community primary care clinics in Chicago, IL and Shreveport, LA were assigned to receive as follows: (1) standard prescription instructions written as times per day (once, twice 3 times per day) (usual care), (2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) (PCL), or (3) PCL instructions with a graphic aid to visually depict dose and timing of the medication (PCL + Graphic). The outcome was correct interpretation of label instructions.Instructions with the PCL format were more likely to be correctly interpreted compared with standard instructions (adjusted relative risk [RR]: 1.33, 95% confidence interval [CI]: 1.25-1.41). Inclusion of the graphic aid (PCL + Graphic) decreased rates of correct interpretation compared with PCL instructions alone (RR: 0.93; 95% CI: 0.89-0.97). Patients with low literacy were better able to interpret PCL instructions (low literacy: RR: 1.39; 95% CI: 1.14-1.68; P = 0.001).The PCL approach could improve patients' understanding and use of their medication regimen.

Dyspnea is a common symptom among patients with heart failure. Currently, there is no standardized, rapid, precise method to assess dyspnea.From a review of the literature, we pooled questions from various questionnaires assessing dyspnea. A total of 201 patients with heart failure completed all questions in the preliminary item bank. Each item asks how much shortness of breath the patient had when doing an activity. Medical charts were reviewed for hospitalization within 1 or 3 months of completing the questions. We created a dyspnea item bank of 44 items. Computer adaptive tests (CAT) generated from this item bank can assess dyspnea by administering on average 10 questions. Simulation CAT scores were generated to compare with the item bank scores. The CAT scores had a correlation of 0.98 with item bank scores. Logistic regression models predicting the probability of being hospitalized from the dyspnea score were statistically significant (P.05). A 5-point score increase was associated with a 32% increased odds of hospitalization in 1 month and a 20% increased odds of hospitalization in 3 months.This computer-based tool for dyspnea assessment obtains similar precision to that of answering the entire dyspnea item bank with less patient burden.

Background Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Discussion Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. Trial Registration ClinicalTrials.gov http://www.clinicaltrials.gov/ NCT00378950

To determine whether mental health scores are associated with self-reported physical limitations after adjustment for physical performance. Patient-reported physical limitations are widely used to assess health status or the impact of disease. However, patients' mental health may influence their reports of their physical limitations.Mental health and physical limitations were measured using the SF-36v2 mental health and physical functioning subscales in a cross-sectional study of 1024 participants. Physical performance was measured using tests of strength, endurance, dexterity, and flexibility. Multivariable linear regression was performed to examine the relationship between self-reported mental health and physical limitations adjusting for age, gender, race/ethnicity, education, body mass index, and measured physical performance.The score distributions for mental health and physical functioning were similar to that of the United States population in this age range. In unadjusted analyses, every 10-point decline in mental health scores was associated with a 4.8-point decline in physical functioning scores (95% Confidence Interval (CI) = -4.2 to -5.3; p.001). After adjusting for covariables including measured physical performance, every 10-point decline in mental health scores was associated with a 3.0-point decline in physical functioning scores (95% CI = -2.5 to -3.6; p.001).People with poor mental health scores seem to report more physical limitations than would be expected based on physical performance. When comparing self-reported physical limitations between groups, it is important to consider differences in mental health.

The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study demonstrated that implantable cardioverter defibrillators (ICDs) significantly reduce the risk of sudden cardiac death in patients with nonischemic cardiomyopathy and an ejection fraction of 35% or less, with no statistically significant decrease in overall mortality. The impact of ICD placement and shock on health-related quality of life (HRQL) in this population is unknown.The 12-Item Medical Outcomes Short-Form Health Survey and the Minnesota Living with Heart Failure Questionnaire were administered to 458 patients with nonischemic cardiomyopathy, an ejection fraction of 35% or less, and either nonsustained ventricular tachycardia or 10 or more premature ventricular depolarizations per hour at baseline, 1 month after randomization, and every 3 months thereafter throughout the trial. The subjects were randomized to an ICD or standard medical therapy. Outcomes were compared using hierarchical linear regression.Overall, there were no significant differences in HRQL throughout the trial between patients randomized to an ICD or standard medical therapy. However, in patients with 1 or more ICD shocks, HRQL declined 0.5 +/- 0.2 (mean +/- SD) points per shock on the emotional scale of the Minnesota Living with Heart Failure Questionnaire (P = .04) and 1.0 +/- 0.5 points per shock on the mental component score of the 12-Item Medical Outcomes Short-Form Health Survey (P = .04).Overall, HRQL was not affected by ICD implantation in patients in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study. Implantable cardioverter defibrillator shock was associated with a reduction in some measures of HRQL, but the effects were unlikely to result in a clinically observable alteration until 5 or more shocks were experienced.

Because depressive symptoms are prevalent among patients with peripheral arterial disease (PAD), our goal was to study the effect of depressive symptoms over time on functional decline among patients with PAD.We conducted a prospective cohort study of 417 patients with PAD followed annually for 2 years. A Geriatric Depression Scale Short Form (GDS-S) score5 was considered positive for depressive symptoms. Depressive symptom categories based on annual GDS-S measures included persistent, new, resolved, and no depressive symptoms. Outcome variables were change in 6-minute walk distance, 4-meter fast walking velocity, and short physical performance battery (0-12 scale, 12 = best). Results are adjusted for age, sex, race, body mass index, marital status, exercise level, smoking, ankle brachial index, leg symptoms, comorbidities, beta-blocker medication use, anti-depressant medications, and interim medical events.In adjusted analyses, patients with new depressive symptoms had greater annual decline in fast walking velocity compared with that of patients with no depressive symptoms (-0.08 versus -0.01 meters/second per year, p = .02). Patients with persistent depressive symptoms had greater annual decline in 6-minute walk distance (-86.4 versus -41.5 feet/yr, p = .04), fast walking velocity (-0.08 versus -0.01 meters/second per year, p = .004), and short physical performance battery (-0.73 versus -0.18 per year, p = .005) compared with that of patients with no depressive symptoms.Among patients with PAD, persistent and new depressive symptoms are associated with greater annual decline in functional performance. Further study is needed to determine the mechanisms of these associations and whether treatment of depressive symptoms prevents functional decline in persons with PAD.

ContextLittle is known regarding the extent to which patient-reported health status, including symptom burden, physical limitation, and quality of life, is determined by psychosocial vs physiological factors among patients with chronic disease.ObjectiveTo compare the contributions of depressive symptoms and measures of cardiac function to the health status of patients with coronary artery disease.Design, Setting, and ParticipantsCross-sectional study of 1024 adults with stable coronary artery disease recruited from outpatient clinics in the San Francisco Bay Area between September 2000 and December 2002.Main MeasuresMeasurement of depressive symptoms using the Patient Health Questionnaire (PHQ); assessment of cardiac function by measuring left ventricular ejection fraction on echocardiography, exercise capacity on treadmill testing, and ischemia on stress echocardiography; and measurement of a range of health status outcomes, including symptom burden, physical limitation, and quality of life, using the Seattle Angina Questionnaire. Participants were also asked to rate their overall health as excellent, very good, good, fair, or poor.ResultsOf the 1024 participants, 201 (20%) had depressive symptoms (PHQ score ≥10). Participants with depressive symptoms were more likely than those without depressive symptoms to report at least mild symptom burden (60% vs 33%; P

This study was designed to determine the association between race and atrial fibrillation (AF) among patients with heart failure (HF).Atrial fibrillation is known to complicate HF, but whether its prevalence varies by race, and the reasons why, are not well understood.We identified adults hospitalized with confirmed HF within a large integrated healthcare delivery system. We obtained information on demographics, comorbidity, vital signs, medications, and left ventricular systolic function status. "Atrial fibrillation" was defined as AF or atrial flutter documented by electrocardiogram or prior physician-assigned diagnoses. We evaluated the independent relationship between race and AF using multivariable logistic regression.Among 1,373 HF patients (223 African Americans, 1,150 Caucasians), the prevalence of AF was 36.9% (95% confidence interval [CI] 34.3% to 39.5%). Compared with Caucasians, African Americans were younger (mean age 67 vs. 74 years, p0.001) and more likely to have hypertension (86.6% vs. 77.7%, p0.01) and prior diagnosed HF (79.4% vs. 70.7%, p0.01). African Americans had less prior diagnosed coronary disease, revascularization, hypothyroidism, or valve replacement. Atrial fibrillation was much less prevalent in African Americans (19.7%) than Caucasians (38.3%, p0.001). After adjustment for risk factors for AF and other potential confounders, African Americans had 49% lower odds of AF (adjusted odds ratio 0.51, 95% CI 0.35 to 0.76).In a contemporary HF cohort, AF was significantly less common among African Americans than among Caucasians. This variation was not explained by differences in traditional risk factors for AF, HF etiology and severity, and treatment.

Background Weight monitoring is an important element of HF self-care, yet the most clinically meaningful way to evaluate weight monitoring adherence is uncertain. We conducted this study to evaluate the association of (1) self-reported recall and (2) daily diary-recorded weight monitoring adherence with heart failure-related (HF-related) hospitalization. Methods We conducted a prospective cohort study among 216 patients within a randomized trial of HF self-care training. All patients had an initial self-care training session followed by 15 calls (median) to reinforce educational material; patients were also given digital scales, instructed to weigh daily, record weights in a diary, and mail diaries back monthly. Weight monitoring adherence was assessed with a self-reported recall question administered at 12 months and dichotomized into at least daily versus less frequent weighing. Diary-recorded weight monitoring was evaluated over 12 months and dichotomized into ≥80% and

Background The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study demonstrated that implantable cardioverter defibrillators (ICDs) significantly reduce the risk of sudden cardiac death in patients with nonischemic cardiomyopathy and an ejection fraction of 35% or less, with no statistically significant decrease in overall mortality. The impact of ICD placement and shock on health-related quality of life (HRQL) in this population is unknown. Methods The 12-Item Medical Outcomes Short-Form Health Survey and the Minnesota Living with Heart Failure Questionnaire were administered to 458 patients with nonischemic cardiomyopathy, an ejection fraction of 35% or less, and either nonsustained ventricular tachycardia or 10 or more premature ventricular depolarizations per hour at baseline, 1 month after randomization, and every 3 months thereafter throughout the trial. The subjects were randomized to an ICD or standard medical therapy. Outcomes were compared using hierarchical linear regression. Results Overall, there were no significant differences in HRQL throughout the trial between patients randomized to an ICD or standard medical therapy. However, in patients with 1 or more ICD shocks, HRQL declined 0.5 ± 0.2 (mean ± SD) points per shock on the emotional scale of the Minnesota Living with Heart Failure Questionnaire ( P = .04) and 1.0 ± 0.5 points per shock on the mental component score of the 12-Item Medical Outcomes Short-Form Health Survey ( P = .04). Conclusions Overall, HRQL was not affected by ICD implantation in patients in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study. Implantable cardioverter defibrillator shock was associated with a reduction in some measures of HRQL, but the effects were unlikely to result in a clinically observable alteration until 5 or more shocks were experienced.

Background: Atrial fibrillation is the most common arrhythmia affecting the elderly. Although the risk of cardioembolic stroke is well defined, the effects of chronic atrial fibrillation on exercise tolerance and quality of life have been less well quantified. Methods: We compared a group of 52 elderly patients with chronic atrial fibrillation to a group of 48 control patients in sinus rhythm. Each patient underwent an interview that incorporated the Short Form-36 Health Survey (SF-36) to quantify individual perceptions on quality of life. In addition each person underwent physiologic testing that included a Modified Bruce Protocol exercise tolerance test, 24-hour ambulatory monitor test, and an echocardiogram. Results: Both groups were elderly, 77 vs 76 years of age (P=0.35).The two groups had similar ejection fractions, 55.4% vs 58.4% (P=0.10). The atrial fibrillation patients demonstrated a higher level of comorbidity based on the Charlson Comorbidity Index, 2.46 vs 1.57 (P=0.03). On formal exercise testing there was no statistical difference in exercise duration between the two groups 9.0 vs 10.1 minutes (P=0.24). Similarly the Physical Summary Score (PCS) and the Mental Summary Score (MCS) of the SF-36 quality of life survey did not demonstrate a statistical difference between the two groups. PCS: 43.0 vs 45.9 (P=0.24); MCS: 52.5 vs 55.7 (P=0.07). Conclusions: Despite a higher level of comorbidity, elderly, ambulatory patients with chronic atrial fibrillation demonstrate similar exercise tolerance and report similar quality of life to a group of age-matched control patients in sinus rhythm. There is a cohort of patients in chronic atrial fibrillation in whom a strategy of rate control and anticoagulation may be appropriate.