Efficient Measurement of Multiple Ventricular Assist Device Patient-reported Outcomes: Creation of a 20-item Profile from the MCS A-QOL Study.

BACKGROUND: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe creation of five self-reported 4-item short forms and the MCS A-QOL 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation. METHODS: Using a cross-sectional sample of patients (n=620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created five 4-item short forms: Satisfaction with Treatment, VAD Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item Profile. Analyses included inter-correlations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity. RESULTS: The 620 patients were mean age=57 years, 78% male, 70% white, and 56% on destination therapy LVADs. Inter-correlations among the five 4-item measures were low to moderate (<0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were >0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the five 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures. CONCLUSIONS: Our five 4-item short forms are reliable and valid and may be used individually or together as a 20-item Profile to assess adjustment and HRQOL in patients who undergo LVAD implantation.

Patients' Perspectives on Plans Generated During Primary Care Visits and Self-Reported Adherence at 3 Months: Data From a Randomized Trial.

BACKGROUND: Effective primary care necessitates follow-up actions by the patient beyond the visit. Prior research suggests room for improvement in patient adherence. OBJECTIVE: This study sought to understand patients' views on their primary care visits, the plans generated therein, and their self-reported adherence after 3 months. METHODS: As part of a large multisite cluster randomized pragmatic trial in 3 health care organizations, patients completed 2 surveys-the first within 7 days after the index primary care visit and another 3 months later. For this analysis of secondary outcomes, we combined the results across all study participants to understand patient adherence to care plans. We recorded patient characteristics and survey responses. Cross-tabulation and chi-square statistics were used to examine bivariate associations, adjusting for multiple comparisons when appropriate. We used multivariable logistic regression to assess how patients' intention to follow, agreement, and understanding of their plans impacted their plan adherence, allowing for differences in individual characteristics. Qualitative content analysis was conducted to characterize the patient's self-reported plans and reasons for adhering (or not) to the plan 3 months later. RESULTS: Of 2555 patients, most selected the top box option (9=definitely agree) that they felt they had a clear plan (n=2011, 78%), agreed with the plan (n=2049, 80%), and intended to follow the plan (n=2108, 83%) discussed with their provider at the primary care visit. The most common elements of the plans reported included reference to exercise (n=359, 14.1%), testing (laboratory, imaging, etc; n=328, 12.8%), diet (n=296, 11.6%), and initiation or adjustment of medications; (n=284, 11.1%). Patients who strongly agreed that they had a clear plan, agreed with the plan, and intended to follow the plan were all more likely to report plan completion 3 months later (P<.001) than those providing less positive ratings. Patients who reported plans related to following up with the primary care provider (P=.008) to initiate or adjust medications (P≤.001) and to have a specialist visit were more likely to report that they had completely followed the plan (P=.003). Adjusting for demographic variables, patients who indicated intent to follow their plan were more likely to follow-through 3 months later (P<.001). Patients' reasons for completely following the plan were mainly that the plan was clear (n=1114, 69.5%), consistent with what mattered (n=1060, 66.1%), and they were determined to carry through with the plan (n=887, 53.3%). The most common reasons for not following the plan were lack of time (n=217, 22.8%), having decided to try a different approach (n=105, 11%), and the COVID-19 pandemic impacted the plan (n=105, 11%). CONCLUSIONS: Patients' initial assessment of their plan as clear, their agreement with the plan, and their initial willingness to follow the plan were all strongly related to their self-reported completion of the plan 3 months later. Patients whose plans involved lifestyle changes were less likely to report that they had "completely" followed their plan. TRIAL REGISTRATION: ClinicalTrials.gov NCT03385512; https://clinicaltrials.gov/study/NCT03385512. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/30431.

Type 2 diabetes-related health measures during the initial COVID-19 surge at an academic internal medicine practice.

The COVID-19 pandemic disrupted chronic disease management in the United States and across the world. This study reports minimal effects of the initial COVID-19 surge on body mass index, blood pressure, cholesterol, and blood glucose control in ambulatory general internal medicine patients with Type 2 diabetes at a single academic center.

Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study.

BACKGROUND: Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device adjustment and health-related quality of life (HRQOL). METHODS: Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n = 620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n = 154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n = 466]). We constructed 5 item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity. RESULTS: Of 620 participants, 56% (n = 345) were implanted as destination therapy, 51% (n = 316) were <12 months post-implantation, mean age = 57.3 years, 78% (n = 485) male, 70% (n = 433) White, 58% (n = 353) married/partnered, and 58% (n = 357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators. CONCLUSIONS: These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

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<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5). 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.

Implementation of Patient Engagement Tools in Electronic Health Records to Enhance Patient-Centered Communication: Protocol for Feasibility Evaluation and Preliminary Results.

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.

The Relationship Between Epidermal Mitotic Density, Atypical Mitotic Figure Density, Breslow Depth, Ulceration, and Dermal Mitotic Rate in Cutaneous Melanoma: A Retrospective Cohort Study.

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.

Soft Tissue Sarcoma, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.

Soft tissue sarcomas (STS) are rare solid tumors of mesenchymal cell origin that display a heterogenous mix of clinical and pathologic characteristics. STS can develop from fat, muscle, nerves, blood vessels, and other connective tissues. The evaluation and treatment of patients with STS requires a multidisciplinary team with demonstrated expertise in the management of these tumors. The complete NCCN Guidelines for STS provide recommendations for the diagnosis, evaluation, and treatment of extremity/superficial trunk/head and neck STS, as well as intra-abdominal/retroperitoneal STS, gastrointestinal stromal tumors, desmoid tumors, and rhabdomyosarcoma. This portion of the NCCN Guidelines discusses general principles for the diagnosis, staging, and treatment of STS of the extremities, superficial trunk, or head and neck; outlines treatment recommendations by disease stage; and reviews the evidence to support the guidelines recommendations.

MedLink: A mobile intervention to improve medication adherence and processes of care for treatment of depression in general medicine.

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.

Self-reported recall and daily diary-recorded measures of weight monitoring adherence: associations with heart failure-related hospitalization.

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 <80% adherence. HF-related hospitalizations were ascertained through patient report and confirmed through record review. RESULTS: Over 12 months in 216 patients, we identified 50 HF-related hospitalizations. Patients self-reporting daily or more frequent weight monitoring had an incidence rate ratio of 1.34 (95% CI 0.24-7.32) for HF-related hospitalizations compared to those reporting less frequent weight monitoring. Patients who completed ≥80% of weight diaries had an IRR of 0.37 (95% CI 0.18-0.75) for HF-related hospitalizations compared to patients who completed <80% of weight diaries. CONCLUSIONS: Self-reported recall of weight monitoring adherence was not associated with fewer HF hospitalizations. In contrast, diary-recorded adherence ≥80% of days was associated with fewer HF-related hospitalizations. Incorporating diary-based measures of weight monitoring adherence into HF self-care training programs may help to identify patients at risk for HF-related hospitalizations.

A single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure.

AIMS AND OBJECTIVES: To determine whether a single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure. BACKGROUND: Poor 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. DESIGN: We performed a prospective cohort study in 592 participants with heart failure within a four-site randomised trial. METHODS: Self-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. RESULTS: Fifty-two percent of participants were 52% male, mean age was 61 years, 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 (0·71 events/year) compared with those with any nonadherence (0·86 events/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. CONCLUSION: A single medication adherence question at baseline predicts hospitalisation and death over one year in heart failure patients. RELEVANCE TO CLINICAL PRACTICE: Medication 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.

Low literacy is associated with increased risk of hospitalization and death among individuals with heart failure.

BACKGROUND: Low 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. METHODS: We studied a cohort of ambulatory patients with symptomatic HF (NYHA Class II-IV within the past 6 months) 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. RESULTS: Of 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 < 0.001). Adjusting for site only, participants with low literacy had an incidence rate ratio (IRR) of 1.39 (95 % CI: 0.99, 1.94) for all-cause hospitalization or death and 1.36 (1.11, 1.66) for HF-related hospitalization. After adjusting for demographic, clinical, and self-management factors, the IRRs were 1.31 (1.06, 1.63) for all-cause hospitalization and death and 1.46 (1.20, 1.78) for HF-related hospitalization. CONCLUSIONS: Low literacy increased the risk of hospitalization for ambulatory patients with heart failure. Interventions designed to mitigate literacy-related disparities in outcomes are warranted.

Multisite randomized trial of a single-session versus multisession literacy-sensitive self-care intervention for patients with heart failure.

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.

The effect of progressive, reinforcing telephone education and counseling versus brief educational intervention on knowledge, self-care behaviors and heart failure symptoms.

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 (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 fraction <0.45; 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. CONCLUSIONS: Telephone reinforcement of learning goals and self-care behaviors improved knowledge, health behaviors, and HF-related QOL compared to a single education session.

"Teach to goal": theory and design principles of an intervention to improve heart failure self-management skills of patients with low health literacy.

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 with 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 multisession educational strategy that teaches patients self-care skills until they reach behavioral goals ("Teach to Goal"). Our intervention 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, it would support the value of incorporating these design principles into educational interventions for other diseases.

Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure.

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 < 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. CONCLUSION: Low 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.

Measuring disparities: bias in the Short Form-36v2 among Spanish-speaking medical patients.

BACKGROUND: 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. OBJECTIVES: 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. SUBJECTS: 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. RESULTS: 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 Index >0.02, root mean square error of approximation change >0.003) 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. CONCLUSIONS: 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.

Brief, valid measures of dyspnea and related functional limitations in chronic obstructive pulmonary disease (COPD).

OBJECTIVE: Chronic 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. METHODS: A 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. RESULTS: The 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. CONCLUSION: The 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.

Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use.

OBJECTIVE: To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared with typical instructions. METHODS: 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. RESULTS: 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). CONCLUSION: The PCL approach could improve patients' understanding and use of their medication regimen.