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Background There has been a growing emphasis on health-related quality of life (HRQoL) as an important outcome in rare disease drug development, although its assessment may be useful outside the drug development context, including in clinical applications or natural history studies. Central to assessing quality of life in health research is utilizing outcome measures that capture symptoms and impacts of the disease and treatment that are important and relevant to patients. Identifying and implementing valid and reliable tools to measure HRQoL in rare diseases poses unique challenges that often require creative solutions. Main body In this commentary, we explore some of the challenges in HRQoL assessment in rare disease, propose solutions, and consider regulatory issues. Some of the solutions discussed entail the use of item banks, adapting existing measures from phenotypically similar disease contexts, use of multi-domain measurement indices, and adapting methods for assessing content validity of existing measures. Current regulatory considerations are discussed and resources outlined. Conclusion Quality of life may be the most important endpoint for patients with rare diseases, and the challenges of valid assessment require effort and innovative thinking specific to each context to improve measurement and clinical outcomes.

Objectives:More than 90% of individuals with Alzheimer’s disease (AD) experience behavioral and neuropsychiatric symptoms (NPS), such as agitation. However, little is known regarding the specific burden of agitation for Alzheimer’s patients.Design:A global systematic literature review was conducted in MEDLINE and Embase for studies of clinical, humanistic, and economic burden of agitation in AD/dementia published from 2006–2016. References of identified papers and related literature reviews were examined. Studies meeting predetermined inclusion criteria for burden of agitation/NPS were summarized.Results:Eighty papers met the inclusion criteria for burden of agitation in dementia. Wide ranges of agitation prevalence were reported, but few papers provided information on incidence. The association of agitation with AD severity was presented in multiple studies; a few suggested positive association of agitation with mortality.Conclusions:High prevalence of agitation is consistent with earlier reports, but several gaps in understanding of agitation in AD need further exploration.

Background To explore the existing evidence of the real-world implementation of patient-reported outcomes (PROs) in oncology clinical practice and address two aims: (1) summarize available evidence of PRO use in clinical practice using a framework based on the International Society for Quality of Life Research (ISOQOL) PRO Implementation Guide; and (2) describe reports of real-world, standardized PRO administration in oncology conducted outside of scope of a research study. Methods A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was developed to guide the systematic literature review (SLR) that was conducted in MEDLINE and Embase databases. A two step search strategy was implemented including two searches based on previously completed reviews. Studies published from 2006 to 2017 were synthesized using a framework based on the ISOQOL PRO Implementation Guide. Results After screening 4427 abstracts, 36 studies met the eligibility criteria. Most elements of the ISOQOL PRO Implementation Guide were followed. Two notable exceptions were found: 1) providing PRO score interpretation guidelines (39% of studies); and 2) providing patient-management guidance for addressing issues identified by PROs (25% of studies). Of the 22 studies with an intervention component, 19 (86%) reported intervention effects on study outcomes. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) was the most commonly used PRO (n = 10, 28%); use of 38 other PRO measures was also reported. Only three studies (8%) reported real-world PRO implementation. Conclusion Reports of real-world PRO implementation are limited. Reports from studies conducted in clinical settings suggest gaps in information on PRO score interpretation and the use of PRO results to inform patient management. Before the promise of practice-based PRO assessment in oncology can be truly realized, investigators need to advance the state-of-the-art of real-time PRO score interpretation as well as developing guidance on how to use PRO insights to drive clinically-meaningful patient-management strategies.

To determine important symptoms and functional effects of venous malformations (VMs) to assess the content validity of commonly used patient-reported outcome (PRO) measures for use with VM patients.This cross-sectional, qualitative study involved cognitive interviews with participants with VM aged ≥ 14 years. From February to June 2016, 11 participants (8 female) with a mean (± standard deviation) age of 31 ± 15 years were recruited from three clinical sites. The following subgroups were evaluated: 5 adults (aged ≥ 18) with trunk/extremity VMs; 3 adolescents (aged 14-17) with trunk/extremity VMs; and 3 adults with head/neck VMs. We evaluated the content validity of the Worst Pain Numeric Rating Scale (NRS), Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference 8-item short form, and PROMIS Physical Function 8-item short form.The most common participant-reported VM symptoms were swelling (n = 10), skin discoloration (n = 8), acute episodic pain (n = 8), chronic pain (n = 7), numbness (n = 7), and tingling/burning (n = 6). Participants reported that VMs affected their physical function (n = 10), appearance (n = 10), relationships/social activities (n = 7), and emotional health (n = 3). The Worst Pain NRS and PROMIS Pain Interference measures were relevant to all participants' VM experience. Only adults with head/neck VMs found the PROMIS Physical Function measure to be irrelevant. The assessed PRO measures did not address several symptoms commonly reported by VM patients (swelling, skin discoloration, numbness, and appearance).These results suggest that several VM symptoms are not assessed fully by commonly used PRO measures, and that the relevance of functional limitation questions may vary by VM location.

Introduction Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. Methods In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. Results Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. Conclusion The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. Funding Eli Lilly & Company. Plain Language Summary Plain language summary available for this article. Electronic supplementary material The online version of this article (10.1007/s13555-017-0213-2) contains supplementary material, which is available to authorized users.

The objective of this study was to identify modifiable factors that improve the reliability of ratings of severity of health care-associated harm in clinical practice improvement and research.A diverse group of clinicians rated 8 types of adverse events: blood product, device or medical/surgical supply, fall, health care-associated infection, medication, perinatal, pressure ulcer, surgery. We used a generalizability theory framework to estimate the impact of number of raters, rater experience, and rater provider type on reliability.Pharmacists were slightly more precise and consistent in their ratings than either physicians or nurses. For example, to achieve high reliability of 0.83, 3 physicians could be replaced by 2 pharmacists without loss in precision of measurement. If only 1 rater was available for rating, ∼5% of the reviews for severe harm would have been incorrectly categorized. Reliability was greatly improved with 2 reviewers.We identified factors that influence the reliability of clinician reviews of health care-associated harm. Our novel use of generalizability analyses improved our understanding of how differences affect reliability. This approach was useful in optimizing resource utilization when selecting raters to assess harm and may have similar applications in other settings in health care.

Background: Psoriasis is a chronic inflammatory skin disease.Objective: To establish content validity and assess psychometric properties of the Psoriasis Symptoms Scale (PSS) in patients with moder...

Objectives The study sought to review the characteristics of existing patient-reported outcome (PRO) instruments used with chronic heart failure (HF) patients and evaluate their potential to support an approved U.S. Food and Drug Administration (FDA) product label claim. Background PROs, including symptoms and their associated functional limitations, contribute substantially to HF patient morbidity. PRO measurements capture the patient perspective and can be systematically assessed with structured questionnaires, however rigorous recommendations have been set by the FDA regarding the acceptability of PRO measures as a basis for product label claims. Methods Extensive searches of databases and specialty guidelines identified PRO instruments used in patients with chronic HF. Information on critical properties recommended by the FDA guidance were systematically extracted and used to evaluate the selected PRO instruments. Results Nineteen PRO instruments used with chronic HF patients were identified. The Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure Questionnaire were the most extensively evaluated and validated in studies of this population. However, judged by criteria listed in the FDA PRO guidance, no existing PRO measure met all of the criteria to support a product label claim in the United States. Conclusions Currently available chronic HF PRO measures do not fulfill all the recommendations provided in the FDA PRO guidance and therefore may not support an FDA-approved product label claim. Future investigations are merited to develop a PRO measure for use in patients with chronic HF in accordance with the FDA guidance.

Background As adults live longer, multiple chronic conditions have become more prevalent over the past several decades. We describe the prevalence of, and patient characteristics associated with, cardiac- and non-cardiac-related multimorbidities in patients discharged from the hospital after an acute coronary syndrome. Methods We studied 2174 patients discharged from the hospital after an acute coronary syndrome at 6 medical centers in Massachusetts and Georgia between April 2011 and May 2013. Hospital medical records yielded clinical information including presence of eight cardiac-related and eight non-cardiac-related morbidities on admission. We assessed multiple psychosocial characteristics during the index hospitalization using standardized in-person instruments. Results The mean age of the study sample was 61 years, 67% were men, and 81% were non-Hispanic whites. The most common cardiac-related morbidities were hypertension, hyperlipidemia, and diabetes (76%, 69%, and 31%, respectively). Arthritis, chronic pulmonary disease, and depression (20%, 18%, and 13%, respectively) were the most common noncardiac morbidities. Patients with ≥4 morbidities (37% of the population) were slightly older and more frequently female than those with 0-1 morbidity; they were also heavier and more likely to be cognitively impaired (26% vs 12%), have symptoms of moderate/severe depression (31% vs 15%), high perceived stress (48% vs 32%), a limited social network (22% vs 15%), low health literacy (42% vs 31%), and low health numeracy (54% vs 42%). Conclusion Multimorbidity, highly prevalent in patients hospitalized with an acute coronary syndrome, is strongly associated with indices of psychosocial deprivation. This emphasizes the challenge of caring for these patients, which extends well beyond acute coronary syndrome management.

Background Healthcare providers play a critical role in the care transitions. Therefore, efforts to improve this process should be informed by their perspectives. Aim The study objective was to explore the factors that negatively/positively influence care transitions following an unplanned hospitalization from the perspective of healthcare providers. Methods A qualitative study using semi-structured interviews conducted between February and September of 2016 at a single academic medical center. We enrolled fifteen healthcare providers from multiple disciplines involved in the management of patients experiencing an unplanned hospitalization. Respondents shared their experiences with care transitions and identified factors within and outside of the discharging health facility that impede or facilitate this process. Transcribed interviews were analyzed using emerging themes from the interviews. Results We identified six themes and associated subthemes from the interviews on factors that influence care transitions. Three themes focused on factors within the discharging healthcare facility: untailored and overloaded patient discharge information, timing of the post-discharge care conversation, provider-to-patient and provider-to-provider miscommunication. The other three themes were related to external factors including caregiver involvement, having a safe and stable housing environment, and access to healthcare and community resources. Providers discussed how these factors positively/negatively influence the hospital-to-home transition. Conclusions Our study identifies factors within and outside the discharging healthcare facility that influence care transitions, ultimately affect patient-centered outcomes and provider satisfaction with delivered care. Strategies aimed at improving the quality of care transitions should address these barriers and actively engage healthcare providers who are pivotal in care transitions.

Background— Cognitive function is often impaired during hospitalization, but whether this impairment resolves or persists after discharge is unknown. Methods and Results— We enrolled (April 2011–May 2013) and interviewed during hospitalization and 1-month post-discharge 1521 nondemented acute coronary syndrome survivors enrolled in TRACE (Transitions, Risks and Actions in Coronary Events). Cognitive function was assessed using the Telephone Interview of Cognitive Status (range: 0–41) at both time points. Patients reported demographic and psychosocial characteristics and medical records were abstracted. Using the Telephone Interview of Cognitive Status cut point of ≤28, we defined 4 groups of cognitive change based on cognitive status during hospitalization and 1 month later: consistently impaired, transiently impaired, newly impaired, and consistently nonimpaired. Characteristics associated with cognitive change categories were examined using multinomial logistic regression. Participants were 67% male, 84% non-Hispanic white, with mean age±SD 62±11 years; 16% (n=237) were cognitively impaired during hospitalization, and 11% (n=174) were impaired 1 month after discharge. Overall, 80% were consistently nonimpaired, 9% transiently impaired, 7% consistently impaired, and 4% newly impaired. Lower education level, minority status, low health literacy and numeracy, and higher severity of disease were independently associated with cognitive impairment during and after hospitalization. Male sex was associated with increased risk of cognitive impairment after hospital discharge. Conclusions— Cognitive function changes during the transition from hospital to home after acute coronary syndrome are less favorable for men and those with psychosocial vulnerability. Assessing cognitive status both in hospital and post-discharge is important for detecting patients who could benefit from tailored transitional care including early follow-up and booster discharge instructions.

Introduction Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs). Methods This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed. Results From the literature review, 52 articles, 44 abstracts, and 41 clinical trials met predefined search criteria. Of these, 11 concepts emerged as having theoretical support for use as measurable impacts of psoriasis symptoms on patients; these concepts included sexual functioning and general health-related quality of life (HRQoL). These concepts were confirmed and expanded upon by two clinicians who routinely care for patients with GenPs. Interviews were then conducted with GenPs patients (n = 20) to discuss the impact of GenPs on their HRQoL. Eighty percent of patients reported that GenPs impacted sexual frequency. The two-item GenPs Sexual Frequency Questionnaire (GenPs-SFQ) was developed to assess limitations on sexual activity frequency because of GenPs. Cognitive debriefing with an additional 50 patients with GenPs confirmed the utility and understandability of the GenPs-SFQ. Conclusion The GenPs-SFQ may have utility in clinical trials involving GenPs patients and in routine clinical practice. Funding Eli Lilly and Company. Plain Language Summary Plain language summary available for this article. Electronic supplementary material The online version of this article (10.1007/s13555-017-0212-3) contains supplementary material, which is available to authorized users.

Patients are participating more actively in health care decision-making with regard to their health, as well as in the broader realm of assessing the value of medical products and influencing decisions about their registration and reimbursement. There is an increasing trend to include patients’ perspectives throughout the stages of medical product development by broadening the traditional study-participant role to that of an active partner throughout the process. Including patients in the selection and development of clinical outcome assessments (COAs) to evaluate the benefit of treatment is particularly important. Still, despite widespread enthusiasm, there is substantial uncertainty regarding how and when to engage patients in this process. This manuscript proposes a methodological framework for engaging patients at varying levels in the selection and development of COAs for medical product development. The framework builds on the Food and Drug Administration’s roadmap for patient-focused COA. Methods for engaging patients across each stage in this roadmap are summarized by levels of engagement. Opportunities and examples of patient engagement (PE) in the selection and/or development of COAs are summarized, together with best practices and practical considerations. This paper offers a framework for understanding, planning, and implementing methods to advance PE in the selection and/or development of COAs for evaluating the benefit of medical products. The intent is to further this important discussion and enhance the process and outcome of PE in this context.

The objective of this study was to evaluate the validity of the Heartburn Reflux Dyspepsia Questionnaire (HRDQ), a newly developed measure of gastro-oesophageal reflux disease (GORD) symptoms. Specifically, the HRDQ was developed for patients, who still experience symptoms with proton pump inhibitor (PPI) treatment.The psychometric properties of HRDQ were evaluated based on data from two clinical trials of patients with GORD with a partial response to PPIs, one from the UK and one from Denmark and Germany.The HRDQ had good internal consistency (Cronbach's alpha range .83-.88) and test-retest reliability (intraclass correlation coefficient range .71-.90). Convergent and discriminant validity were supported by high correlations with ReQuest™ and ability to differentiate between groups based on ReQuest™ cut-off values. Responsiveness of HRDQ was demonstrated by moderate to high correlations with ReQuest™ change scores and time with symptoms. An HRDQ cut-off value of 0.70 for definition of 'bad day' was also evaluated.Based on existing evidence, the HRDQ is a valid and reliable measure of GORD symptoms that can be used as a study outcome in clinical trials.

Background Patient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process. Methods Concept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items. Results During concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders. Conclusion Development of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program.

OBJECTIVE: To examine policy makers' public policy priorities related to physical activity and the built environment, identify classes of policy makers based on priorities using latent class analysis, and assess factors associated with class membership. DESIGN: Cross-sectional survey data from municipal officials in 94 cities and towns across 6 US states were analyzed. PARTICIPANTS: Participants (N = 423) were elected or appointed municipal officials spanning public health, planning, transportation/public works, community and economic development, parks and recreation, and city management. MAIN OUTCOME MEASURES: Participants rated the importance of 11 policy areas (public health, physical activity, obesity, economic development, livability, climate change, air quality, natural resource conservation, traffic congestion, traffic safety, and needs of vulnerable populations) in their daily job responsibilities. Latent class analysis was used to determine response patterns and identify distinct classes based on officials' priorities. Logistic regression models assessed participant characteristics associated with class membership. RESULTS: Four classes of officials based on policy priorities emerged: (1) economic development and livability; (2) economic development and traffic concerns; (3) public health; and (4) general (all policy areas rated as highly important). Compared with class 4, officials in classes 1 and 3 were more likely to have a graduate degree, officials in class 2 were less likely to be in a public health job/department, and officials in class 3 were more likely to be in a public health job/department. CONCLUSIONS: Findings can guide public health professionals in framing discussions with policy makers to maximize physical activity potential of public policy initiatives, particularly economic development. Language: en

Background: As adults live longer, multiple chronic conditions have become more prevalent over the past several decades. We describe the prevalence of, and patient characteristics associated with, cardiac and non-cardiac-related multimorbidities in patients discharged from the hospital after an acute coronary syndrome (ACS). Methods: We studied 2,174 patients discharged from the hospital after an ACS at 6 medical centers in Massachusetts and Georgia between April, 2011 and May, 2013. Hospital medical records yielded clinical information including presence of 8 cardiac-related and 8 non-cardiac-related morbidities on admission. We assessed multiple psychosocial characteristics during the index hospitalization using standardized in-person instruments. Results: The mean age of the study sample was 61 years, 67% were men, and 81% were non-Hispanic whites. The most common cardiac-related morbidities were hypertension, hyperlipidemia, and diabetes (76%, 69%, and 31%, respectively). Arthritis, chronic pulmonary disease, and depression (20%, 18%, and 13%, respectively) were the most common non-cardiac morbidities. Patients with ≥4 morbidities (37% of the population) were slightly older and more frequently female than those with 0-1 morbidity; they were also heavier and more likely to be cognitively impaired (26% vs. 12%), have symptoms of moderate/severe depression (31% vs. 15%), high perceived stress (48% vs. 32%), a limited social network (22% vs. 15%), low health literacy (42% vs. 31%), and low health numeracy (54% vs. 42%). Conclusions: Multimorbidity, highly prevalent in patients hospitalized with an ACS, is strongly associated with indices of psychosocial deprivation. This emphasizes the challenge of caring for these patients, which extends well beyond ACS management.

To evaluate the validity and participants' acceptance of an online assessment of role function using computer adaptive test (RF-CAT).The RF-CAT and a set of established quality of life instruments were administered in a cross-sectional study in a panel sample (n = 444) recruited from the general population with over-selection of participants with selected self-report chronic conditions (n = 225). The efficiency, score accuracy, validity, and acceptability of the RF-CAT were evaluated and compared to existing measures.The RF-CAT with a stopping rule of six items with content balancing used 25 of the available bank items and was completed on average in 66 s. RF-CAT and the legacy tools scores were highly correlated (.64-.84) and successfully discriminated across known groups. The RF-CAT produced a more precise assessment over a wider range than the SF-36 Role Physical scale. Patients' evaluations of the RF-CAT system were positive overall, with no differences in ratings observed between the CAT and static assessments.The RF-CAT was feasible, more precise than the static SF-36 RP and equally acceptable to participants as legacy measures. In empirical tests of validity, the better performance of the CAT was not uniformly statistically significant. Further research exploring the relationship between gained precision and discriminant power of the CAT assessment is needed.

Role functioning (RF) is a key component of health and well-being and an important outcome in health research. The aim of this study was to develop an item bank to measure impact of health on role functioning.A set of different instruments including 75 newly developed items asking about the impact of health on role functioning was completed by 2,500 participants. Established item response theory methods were used to develop an item bank based on the generalized partial credit model. Comparison of group mean bank scores of participants with different self-reported general health status and chronic conditions was used to test the external validity of the bank.After excluding items that did not meet established requirements, the final item bank consisted of a total of 64 items covering three areas of role functioning (family, social, and occupational). Slopes in the bank ranged between .93 and 4.37; the mean threshold range was -1.09 to -2.25. Item bank-based scores were significantly different for participants with and without chronic conditions and with different levels of self-reported general health.An item bank assessing health impact on RF across three content areas has been successfully developed. The bank can be used for development of short forms or computerized adaptive tests to be applied in the assessment of role functioning as one of the common denominators across applications of generic health assessment.

Role functioning (RF) is an important part of health-related quality of life, but is hard to measure due to the wide definition of roles and fluctuations in role participation. This study aims to explore the dimensionality of a newly developed item bank assessing the impact of health on RF.A battery of measures with skip patterns including the new RF bank was completed by 2,500 participants answering only questions on social roles relevant to them. Confirmatory factor analyses were conducted for the participants answering items from all conceptual domains (N = 1193). Conceptually based dimensionality and method effects reflecting positively and negatively worded items were explored in a series of models.A bi-factor model (CFI = .93, RMSEA = .08) with one general and four conceptual factors (social, family, occupation, generic) was retained. Positively worded items were excluded from the final solution due to misfit. While a single factor model with methods factors had a poor fit (CFI = .88, RMSEA = .13), high loadings on the general factor in the bi-factor model suggest that the RF bank is sufficiently unidimensional for IRT analysis.The bank demonstrated sufficient unidimensionality for IRT-based calibration of all the items on a common metric and development of a computerized adaptive test.

Background: Care transitions are a topic of increasing interest as researchers and clinicians focus their effects on patient outcomes. Engaging caregivers, who play important roles in care transitions, may yield valuable insight into how care transition processes can be improved. Methods: We conducted semi-structured interviews, focusing on caregivers’ experiences with and perceptions of care transitions, with 11 eligible caregivers whose loved ones had recently experienced an unplanned admission to a single academic medical center. Our research team analyzed the transcripts to identify key themes.Results: Caregivers detailed multiple factors affecting care transitions, including both in-hospital and external elements. Identifying the medical provider in charge of care emerged as a common difficulty. Other areas of interest included receiving discharge information, length of stay, health insurance status, the presence of social support, access to transportation and educational level, among others. Caregivers’ views on the quality of various in-hospital aspects of their own care transition experiences varied.Conclusions: Caregivers re-affirmed the complexity of the care transition process by identifying myriad factors that influence their quality. Taking steps to address these factors may help hospitals to empower and engage caregivers, as well as to improve care transitions overall and better manage the health of their patients.

Background: Suboptimal care transitions from the hospital to home (transitions) may lead to adverse patient outcomes. As reimbursement becomes increasingly linked with clinical and patient-centered outcomes, providers have strong incentives to better manage transitions. Patients may offer key insights to better assess and improve transitions.Methods: In this qualitative study, we performed semi-structured concept elicitation interviews with patients experiencing a transition following an unplanned hospitalization in medical and surgical wards at a single academic medical center. Three analysts independently analyzed transcripts to identify themes within and outside the medical centers that influenced patients’ transition.Results: Our analyses of interview transcripts of patients (n=22) identified 4 themes related to actions of discharging medical centers and 5 themes outside of the direct purview of the discharging hospital that influence transitions. In the medical center, participants generally described positive roles for quality patient-centered care, opportunities for patient participation, comprehensive discharge education and coordination of medical services on their transitions. Outside of the medical center, participants reported that having caregiver support, social support, health literacy, adequate health insurance and accessibility to healthcare and non-healthcare resources following hospital discharge assisted their transitions.Conclusions: This qualitative study suggests that successful transitions result from actions of medical centers to engage and assist patients, as well as from patients’ access to sociodemographic and psychosocial resources. Future work on strategies to develop better patient-centered transitions and their impact on patient outcomes is warranted.

Role functioning is an important part of health-related quality of life. However, assessment of role functioning is complicated by the wide definition of roles and by fluctuations in role participation across the life-span. The aim of this study is to explore variations in role functioning across the lifespan using qualitative approaches, to inform the development of a role functioning item bank and to pilot test sample items from the bank.Eight focus groups were conducted with a convenience sample of 38 English-speaking adults recruited in Rhode Island. Participants were stratified by gender and four age groups. Focus groups were taped, transcribed, and analyzed for thematic content.Participants of all ages identified family roles as the most important. There was age variation in the importance of social life roles, with younger and older adults rating them as more important. Occupational roles were identified as important by younger and middle-aged participants. The potential of health problems to affect role participation was recognized. Participants found the sample items easy to understand, response options identical in meaning and preferred five response choices.Participants identified key aspects of role functioning and provided insights on their perception of the impact of health on their role participation. These results will inform item bank generation.

The aim of this article is to report the development and preliminary testing of a prototype computerized adaptive test of chronic pain (CHRONIC PAIN-CAT) conducted in 2 stages: (1) evaluation of various item selection and stopping rules through real data-simulated administrations of CHRONIC PAIN-CAT; (2) a feasibility study of the actual prototype CHRONIC PAIN-CAT assessment system conducted in a pilot sample. Item calibrations developed from a US general population sample (N = 782) were used to program a pain severity and impact item bank (kappa = 45), and real data simulations were conducted to determine a CAT stopping rule. The CHRONIC PAIN-CAT was programmed on a tablet PC using QualityMetric's Dynamic Health Assessment (DYHNA) software and administered to a clinical sample of pain sufferers (n = 100). The CAT was completed in significantly less time than the static (full item bank) assessment (P.001). On average, 5.6 items were dynamically administered by CAT to achieve a precise score. Scores estimated from the 2 assessments were highly correlated (r = .89), and both assessments discriminated across pain severity levels (P.001, RV = .95). Patients' evaluations of the CHRONIC PAIN-CAT were favorable.This report demonstrates that the CHRONIC PAIN-CAT is feasible for administration in a clinic. The application has the potential to improve pain assessment and help clinicians manage chronic pain.

The goal of this study was to develop, translate, and evaluate measures for decisional balance and situational temptations for Bulgarian adolescent nonsmokers and to test the predicted relationships with stages of change. Students in the last grades of high school (15-19 years old) recruited in 12 randomly selected schools participated in the study. Data from the 369 nonsmokers (61.8% female, mean age 16.4 years, 97.1% Bulgarian) were used in the measurement development. A two-factor model for decisional balance (CFI=.94) and a hierarchical three-factor model for temptations (CFI=.90) demonstrated the best fit. The predicted crossover pattern for decisional balance and decreasing trend for temptations across the stages of change was verified. Both measures demonstrated tau-equivalent invariance across gender, in addition to good psychometric properties. These results, with the caveat of the noted limitations, support the cross-cultural validity of these transtheoretical model (TTM) constructs and indicate that they can be used as a basis for development of smoking prevention interventions.

Objective: The American Heart Association (AHA), recognizing critical knowledge gaps, has called for more research into determinants of patient functional status. We sought to identify longitudinal patterns (trajectories) of functional status and their predictors during 6 months following an acute coronary syndrome (ACS) discharge. Methods: We used data from the Transitions, Risks, and Actions in Coronary Events - Center for Cardiovascular Outcomes and Education (TRACE-CORE) prospective cohort of patients hospitalized with ACS. We measured physical limitations using the Seattle Angina Questionnaire at the index hospitalization and at 1-, 3-, and 6-months post-discharge. The Seattle Angina Questionnaire physical limitation sub-score (SAPL) ranges 1-100; higher scores indicate fewer limitations. We identified subgroups of patients with distinctive SAPL trajectories and predictors of those trajectories. Results: Participants (N=470) had mean age 62.8 (SD 10.8) years; 26.6% were female and 86.2%, white. We identified 2 SAPL trajectories: MINOR and MODERATE impairment. The majority of participants (80.3%) had MINOR impairment at baseline (mean SAPL 88.2) and modestly improving scores over time. A minority (19.7%) had MODERATE impairment at baseline (mean SAPL score 61.2) and modestly improving scores over time (Figure 1). With MODERATE limitation as the referent, we found that older age predicted membership in the MINOR limitation group (Odds Ratio [OR] per 10-years 2.28), as did being white (OR 4.07) and male (OR 3.50). Patients with co-morbidities (chronic lung disease OR= 0.31, hypertension OR= 0.34, peripheral vascular disease OR= 0.27) were less likely to have MINOR limitations, while those with acute myocardial infarction were more likely than those with unstable angina (NSTEMI OR= 2.95 and STEMI OR=6.23) to have MINOR limitations. [All p < 0.05]. Conclusions: Traditional analyses without trajectories did not reveal the MODERATE subgroup with enduring deficits in physical function. Identifying and intervening early may help to improve post-hospitalization quality of life for patients with poorer expected trajectories. Trajectories of Physical Function Over Time Following Discharge from an Acute Coronary Syndrome Hospitalization

We examined the proportion of patients perceiving their heart condition to be cured following hospitalization for ACS and identified characteristics associated with these perceptions.We conducted a prospective cohort study of adults hospitalized with ACS (N=396). Patient interviews during hospitalization and one week post-discharge provided demographic and psychosocial characteristics. Medical records provided clinical characteristics. At one week, patients who rated "My heart condition is cured" as "definitely true" or "mostly true" were considered to perceive their heart condition cured.Participants were aged 60.7 (SD:11.0) years, 26.5% female, and 89.0% non-Hispanic white; 16.7% had unstable angina, 59.6% NSTEMI, and 23.7% STEMI. One week post-discharge, 30.3% perceived their heart condition to be cured. Characteristics associated with cure perceptions were older age (OR=2.2; 95% CI: 1.2-4.0 for ≥65 years vs55 years), male sex (OR=2.4; 95%CI: 1.3-4.2), history of hypertension (OR=1.8; 95%CI: 1.1-3.1), history of stroke (OR=4.2; 95%CI: 1.1-16.7), no history of CHD (OR=2.8; 95%CI: 1.6-4.9), and receipt of CABG during hospitalization (OR=4.8, 95%CI: 1.9-12.0 vs medical management).One week post-discharge, 3 in 10 patients perceived their heart condition to be cured.Conversations with patients should frame ACS as a chronic disease and dispel cure perceptions.

Purpose The Quality-of-life (QOL) Disease Impact Scale (QDIS) standardizes the content and scoring of QOL impact attributed to different diseases using item response theory (IRT). This study examined the IRT invariance of the QDISstandardized IRT parameters in an independent sample. Method The differential functioning of items and test (DFIT) of a static short-form (QDIS-7) was examined across two independent sources: patients hospitalized for acute coronary syndrome (ACS) in the TRACE-CORE study (N = 1,544) and chronically ill US adults in the QDIS standardization sample. ‘‘ACS-specific’’ IRT item parameters were calibrated and linearly transformed to compare to ‘‘standardized’’ IRT item parameters. Differences in IRT model-expected item, scale and theta scores were examined. The DFIT results were also compared in a standard logistic regression differential item functioning analysis. Results Item parameters estimated in the ACS sample showed lower discrimination parameters than the standardized discrimination parameters, but only small differences were found for thresholds parameters. In DFIT, results on the non-compensatory differential item functioning index (range 0.005–0.074) were all below the threshold of 0.096. Item differences were further canceled out at the scale level. IRT-based theta scores for ACS patients using standardized and ACS-specific item parameters were highly correlated (r = 0.995, root-mean-square difference = 0.09). Using standardized item parameters, ACS patients scored one-half standard deviation higher (indicating greater QOL impact) compared to chronically ill adults in the standardization sample. Conclusion The study showed sufficient IRT invariance to warrant the use of standardized IRT scoring of QDIS-7 for studies comparing the QOL impact attributed to acute coronary disease and other chronic conditions.

The goal of this project was to explore the factors associated with smoking behavior among Bulgarian adolescents. A sample recruited from 12 high schools in Bulgaria (N = 673, mean age = 16.52, 65% female), was used for the analyses in this paper. A series of logistic regressions were performed to explore the factors associated with smoking cessation and increased risk of smoking initiation. Based on self-reported smoking status participants completed different sets of questionnaires and were included in separate models exploring smoking cessation and increased risk of smoking initiation. Variables consistently associated with smoking like stress, coping strategies, peer influence, family influence, exposure to tobacco related marketing were included as predictor variables in both models. In addition each of the two models included the relevant constructs of decisional balance and temptations from the Transtheoretical Model (TTM). The final logistic model differentiating smokers/ex-smokers included age, parental smoking status, Temptation to smoke, and support for smoking bans in public places as variables, correctly classifying 82.3% of the sample. The final model among nonsmokers differentiating higher risk/lower risk of smoking initiation included the strength of the belief that smoking is harmful, Temptations to try smoking, Pros of being smoke-free, and support for smoking bans in public places, correctly classifying 72.7% of the sample. These results provide better understanding of the factors associated with smoking behavior in Bulgarian adolescents that can guide the development of smoking cessation and prevention programs for this population.

Recent cluster analyses based on the Pros and Cons and the Situational Temptations measures performed within the stages of change defined by the Transtheoretical Model have suggested the existence of distinct cluster subtypes. The goal of this study is to replicate cluster subtypes within the Preparation stage of change in a secondary analysis of data from a sample of current smokers (N=3967). Identification of stable cluster subtypes would permit the development of tailored interventions focusing on these subtypes.Two random samples of approximately 340 subjects were selected from the 686 participants in the Preparation stage. The cluster analyses were performed using the Pros, Cons and Situational Temptations. Interpretability of the pattern, pseudo F test, and dendograms were used to determine the number of clusters.Four distinct cluster subtypes (Classic, Progressing, Early Preparation, and Disengaged) were found and replicated across samples. The clusters were externally validated using the ten processes of change and two smoking behavior variables. Statistically significant (p0.05) multivariate effects were found for the ten processes of change and the smoking behavior variables (p0.001) in the two samples.The cluster patterns replicate earlier findings and provide evidence for the existence of clusters subtypes within the Preparation stage of change.

Tailored interventions based on stage of change and other Transtheoretical Model constructs have been effective for promoting smoking cessation. Recent cluster analyses based on the Pros and Cons from the Decisional Balance and the Situational Temptations measures performed within the stages have suggested the existence of distinct cluster subtypes. Cluster subtypes would permit the development of tailored interventions focusing on these subtypes. This study attempts to replicate cluster subtypes within the Contemplation stage of change in a secondary analysis of data from a sample of current smokers (N=3967).Four random samples of 400 were selected from the 1734 Contemplators. The cluster analyses were performed using the Pros, Cons, and Situational Temptations. Interpretability of the pattern, pseudo-F-test, and dendograms were used to determine the number of clusters.Four distinct cluster subtypes (Classic Contemplators, Progressing, Early Contemplators, and Disengaged) were found and replicated across samples. The clusters were externally validated using the 10 Processes of change and 2 smoking behavior variables (cigarettes per day and time before first morning cigarette). Statistically significant (p0.05) multivariate effects were found for the 10 Processes of change in all four samples. The cluster groups differed on 7 or more of the processes in each sample. Significant multivariate effects were also found for the smoking behavior variables in all samples (p0.001).The cluster patterns closely replicate earlier findings and provide evidence for the existence of clusters subtypes within the Contemplation stage of change.

Background: Short hospital stays and fragmented care make the transition following hospitalization a high-risk period for ACS patients. Identified risks for rehospitalization and complications associated with transitions include demographic (e.g., older age), clinical (e.g., co-morbidities), and psychosocial (e.g., depression, lack of social support) factors. Thus, one might expect high-risk patients to receive better quality transitional care to minimize negative outcomes; alternatively, the quality of care may be yet another outcome influenced by the same risk factors. Little is known about the predictors of quality of care transitions from the patients’ perspective. Methods: We studied 1,545 TRACE-CORE patients (mean age = 62, 34% female, 78% non-Hispanic white) admitted with an ACS who completed in-hospital interviews and the Care Transition Measure (CTM) at 1 month after discharge. High quality transitions were indicated by a CTM-15 score >74. Using logistic regression models we examined the association between in-hospital demographic, clinical, and psychosocial characteristics, generic and disease specific quality of life, health literacy and numeracy, and cognitive status with high quality transitions (see Table for measures). Results: Over one-third (36%) of participants (n=552) reported high quality transitions after an ACS. Most variables or interest were associated (p < .20) with care transition quality in bivariate analyses (Table 1). After adjustment, in-hospital cognitive impairment (Odds Ratio (OR) 0.68; 95% CI 0.46, 0.98) and older age (OR 0.99; CI 0.98, 1.00) were negatively associated with reporting high care transition quality, while high levels of social support (OR 1.06; CI 1.03, 1.10) and patient activation (OR 1.46; CI 1.02, 2.09) increased the chance of reporting high care transition quality in a multivariable model. Conclusions: Older patients, those with cognitive impairment, low social support, or lower patient activation may be at risk for lower-quality transitions following hospitalization for ACS, and may benefit from extra attention and support during the transition from hospital to home.

Background: Recent decades have seen improvements in treatment for acute coronary syndromes (ACS), reduced mortality, and shortened hospital stays. Limited evidence suggests that some patients may leave the hospital with the perception that they are cured. Objective: To describe demographic and clinical characteristics associated with patient perceptions that their heart condition is cured at one week following hospitalization for ACS. Methods: We analyzed data from 397 patients interviewed during hospitalization for ACS in 2011-2013 as part of the Transitions, Risks, and Actions in Coronary Events: Centers for Outcomes Research and Education (TRACE-CORE), and again at one week post-discharge as part of an ancillary study, TRACE-CARE. At one week, patients were asked “How true or false is this statement for you: My heart condition is cured. Would you say that this is definitely true, mostly true, neutral, mostly false, or definitely false?” We considered patients who responded “definitely true” or “mostly true” to perceive that their heart condition was cured. We calculated 6-month GRACE risk scores using clinical data from medical records. We used multivariable logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations with cure perceptions. Results: Participants were 26% (n=105) female and 89% (n=350) non-Hispanic white with mean age 60.7±11.0 years. Sixteen percent (n=63) were hospitalized with unstable angina, 69% (n=266) with NSTEMI, and 14% (n=55) with STEMI; 31% (n=124) had a history of CHD; and the average GRACE risk score was 93.6 (SD: 26.6). Seventy-three percent (n=289) received PCI during hospitalization and 11% (n=43) CABG. Discharge occurred the same or next day for 19% (n=76) and within 2-3 days for 54% (n=214). One week post-discharge, 30% (n=120) perceived their heart condition was cured. In a multivariable model, male sex, unstable angina, no history of CHD, and receipt of CABG were associated with greater odds of perceiving oneself cured (Table). Conclusions: One week post-discharge for ACS, 3 in 10 patients perceived their heart condition was cured. Future research should examine additional patient factors related to cure perceptions, and whether these perceptions influence engagement in recommended secondary prevention strategies.

Objective: Quality of transitional care is associated with important health outcomes such as rehospitalization, increased medical errors, and costs. A widely used measure of the construct, the Care Transitions Measure (CTM-15), was developed and validated with relatively small samples and classical test theory approach. The short version of the measure (CTM-3) was recently included in the CAHPS® Hospital Survey. We aimed to conduct a psychometric evaluation of the CTM-15 in a large sample and evaluate whether an item response theory (IRT) based scoring would lead to better measurement precision. Methods: As part of TRACE-CORE 1545 participants were interviewed during hospitalization for ACS providing information on general health status (SF-36). At 1 month following discharge, patients completed CTM items, health utilization and care process questions. We evaluated the psychometric properties of the CTM using descriptive statistics, factor analyses, and item response theory analyses. We compared the measurement precision of CTM-15, CTM-3, and a CTM-IRT based score using relative validity (RV) coefficients. Results: Participants were 79% non-Hispanic white, 67% male, 27% with a college education or higher (27%) and average age of 62 years. The CTM scale had good internal consistency (Cronbach’s alpha=0.95), but demonstrated strong acquiescence bias (8.7% participants responded “Strongly agree”, 19% “Agree” to all 15 items) and limited score variability (5% Conclusion: We identified psychometric challenges of the CTM, which may limit its value in research and practice. The strong acquiescence bias in the measure leads to highly skewed, clustered scores with restricted score variance and makes it difficult to differentiate between levels of care transition quality. In the absence of guidelines on meaningfully important differences, it is hard to determine whether detected statistically significant differences in care transition quality are important. These results are in line with emerging evidence of gaps in the validity of the measure.

Background The quality of transitional care is associated with important health outcomes such as rehospitalization and costs. The widely used Care Transitions Measure ( CTM ‐15) was developed with a classic test theory approach; its short version ( CTM ‐3) was included in the CAHPS Hospital Survey. We conducted a psychometric evaluation of both measures and explored whether item response theory ( IRT ) could produce a more precise measure. Methods and Results As part of the Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education, 1545 participants were interviewed during an acute coronary syndrome hospitalization, providing information on general health status ( Short Form ‐36), CTM ‐15, health utilization, and care process questions at 1 month postdischarge. We used classic and IRT analyses and compared the measurement precision of CTM ‐15–, CTM ‐3–, and CTM ‐ IRT –based score using relative validity. Participants were 79% non‐Hispanic white and 67% male, with an average age of 62 years. The CTM ‐15 had good internal consistency (Cronbach's α=0.95) but demonstrated acquiescence bias (8.7% participants responded “Strongly agree” and 19% responded “Agree” to all items) and limited score variability. These problems were more pronounced for the CTM ‐3. The CTM ‐15 differentiated between patient groups defined by self‐reported health status, health care utilization, and care transition process indicators. Differences between groups were small (2 to 3 points). There was no gain in measurement precision from IRT scoring. The CTM ‐3 was not significantly lower for patients reporting rehospitalization or emergency department visits. Conclusion We identified psychometric challenges of the CTM , which may limit its value in research and practice. These results are in line with emerging evidence of gaps in the validity of the measure.

Background Therapeutic misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut the process of obtaining meaningful consent to clinical research participation. Previous studies have found that TM is widespread, but progress in addressing TM has been stymied by the absence of a validated method for assessing its presence. Purpose The goal of this study was to develop and validate a theoretically grounded measure of TM, assess its diagnostic accuracy, and test previous findings regarding TM’s prevalence. Methods A total of 220 participants were recruited from clinical trials at four academic medical centers in the United States. Participants completed a 28-item Likert-type questionnaire to assess the presence of beliefs associated with TM, and a semistructured TM interview designed to elicit their perceptions of the nature of the clinical trial in which they were participating. Data from the questionnaires were subjected to factor analysis, and items with poor factor loadings were excluded. This resulted in a 10-item scale, with three strongly correlated factors and excellent internal consistency; the fit indices of the model across 10 training sets were consistent with the original results, suggesting a stable factor solution. Results The scale was validated against the TM interview, with significantly higher scores among subjects coded as displaying evidence of TM. Receiver operating curve (ROC) analysis based on a 10-fold internal cross-validation yielded area under the ROC (AUC) = 0.682 for any evidence of TM. When sensitivity (0.72) and specificity (0.61) were both optimized, positive predictive value was 0.65 and negative predictive value was 0.68, with a positive likelihood ratio of 1.89 and a negative likelihood ratio of 0.47. In all, 50.5% (n = 101) of the participants manifested evidence of TM on the TM interview, a somewhat lower rate than in most previous studies. Limitations The predictive value of the scale compared with the ‘gold standard’ clinical interview is modest, although similar to other instruments based on self-report assessing states of mind rather than discrete symptoms. Thus, although the scale can offer evidence of which subjects are at risk for distortions in their decisions and to what degree, it will not allow researchers to conclude definitively that TM is present in a given subject. Conclusions The development of a reliable and valid TM scale, even with modest predictive power, should permit investigators in clinical trials to identify subjects with tendencies to misinterpret the nature of the situation and to provide additional information to them. It should also stimulate research on how best to decrease TM and facilitate meaningful informed consent to clinical research.

Background— Cardiovascular disease continues to cause significant morbidity, mortality, and impaired quality of life, with unrealized health gains from the underuse of available evidence. The Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) aims to advance the science of acute coronary syndromes by examining the determinants and outcomes of the quality of transition from hospital to community and by quantifying the impact of potentially modifiable characteristics associated with decreased quality of life, rehospitalization, and mortality. Methods and Results— TRACE-CORE comprises a longitudinal multiracial cohort of patients hospitalized with acute coronary syndromes, 2 research projects, and development of a nucleus of early stage investigators. We are currently enrolling 2500 adults hospitalized for acute coronary syndromes at 6 hospitals in the northeastern and southeastern United States. We will follow these patients for 24 months after hospitalization through medical record abstraction and 5 patient interviews focusing on quality of life, cardiac events, rehospitalizations, mortality, and medical, behavioral, and psychosocial characteristics. The Transitions Project studies determinants of and disparities in outcomes of the quality of patients’ transition from hospital to community. Focusing on potentially modifiable factors, the Action Scores Project will develop and validate action scores to predict recurrent cardiac events, death, and quality of life, describe longitudinal variation in these scores, and develop a dashboard for patient and provider action on the basis of these scores. Conclusions— In TRACE-CORE, sound methodologic principles of observational studies converge with outcomes and effectiveness research approaches. We expect that our data, research infrastructure, and research projects will inform the development of novel secondary prevention approaches and underpin the careers of cardiovascular outcomes researchers.

Computerized adaptive tests (CATs) have abundant theoretical advantages over established static instruments, which could improve ambulatory monitoring of patient-reported outcomes (PROs). However, an empirical demonstration of their practical benefits is warranted.We reviewed the literature and evaluated existing data to discuss the potential of CATs for use in ambulatory monitoring outside clinical facilities.Computerized adaptive tests are not being used for ambulatory monitoring, but initial results from their use in health care research allow for discussion of some issues relevant to ambulatory care. Evidence shows that CATs can capture the most relevant health outcomes as well as established static tools, with substantially decreased respondent burden. They can be more precise than static tools of similar length and can reduce floor and ceiling effects. Computerized adaptive tests can reliably measure a construct over time with different items, which yields the potential of introducing item exposure control in ambulatory monitoring. Studies have shown that CATs can be at least as valid as well-designed static tools in group comparisons, but further investigation is needed to determine whether psychometric advantages lead to increased responsiveness of CATs.Ambulatory monitoring of PROs demands short, yet very precise measurements, which can be repeated up to many times a day. Computerized adaptive tests may address several present shortcomings in ambulatory monitoring of PROs efficiently. However, most CAT developments have primarily focused on psychometric improvements. To use the full potential of CATs for ambulatory monitoring purposes, content must also be carefully considered.

Background— Assessment of dyspnea, fatigue, and physical disability is fundamental to the monitoring of patients with heart failure (HF). A plethora of patient-reported measures exist, but most are too burdensome or imprecise to be useful in clinical practice. New techniques used for computer adaptive tests (CATs) may be able to address these problems. The purpose of this study was to build a CAT for patients with HF. Methods and Results— Item banks of 74 queries (“items”) were developed to assess self-reported physical disability, fatigue, and dyspnea. All queries were administered to 658 adults with HF to build 3 item banks. The resulting HF-CAT was administered to 100 patients with ancillary HF (New York Heart Association I, 11%; II, 53%; III and IV, 36%). In addition, the physical function and vitality domains of the SF-36 Health Survey questionnaire, an established shortness-of-breath scale, and the Minnesota Living with Heart Failure Questionnaire were applied. The HF-CAT assessment took 3:09±1:52 minutes to complete and score. All HF-CAT scales demonstrated good construct validity through high correlations with the corresponding SF-36 Health Survey physical function ( r =−0.87), vitality ( r =−0.85), and shortness-of-breath ( r =0.84) scales. Simulation studies showed a more precise measurement of all HF-CAT scales over a larger range than comparable static tools. The HF-CAT scales identified significant differences between patients classified by the New York Heart Association symptom criteria, similar to the Minnesota Living with Heart Failure Questionnaire. Conclusions— A new CAT for patients with HF was built using modern psychometric methods. Initial results demonstrate its potential to increase the feasibility and precision of patient self-assessments of symptoms of HF with minimized respondent burden. Clinical Trial Registration— URL: http://www.projectreporter.nih.gov . Unique identifier: 1R43HL083622-01.

The Transtheoretical Model constructs have been used in the development of effective tailored interventions for smoking cessation. Recent studies have suggested the existence of clusters within each stage of change, based on measures of the Pros, Cons and the Situational Temptations. The goal of this study is to replicate cluster subtypes within the Precontemplation stage of change in a secondary analysis of data from a sample of current smokers (N=3967). Four random samples ranging from 312 to 400 participants were selected from the Precontemplators subgroup. The cluster analyses were performed using Ward's Method on the standard scores from the three scales. Interpretability of the pattern, pseudo F test, and dendograms were used to determine the number of clusters. Four cluster subtypes were found and replicated across samples. The ten processes of change and two smoking behavior variables were used in the external validation of clusters. Statistically significant multivariate effects were found for the processes of change (p

The goal of this study was to develop measures for Decisional Balance and Situational Temptations for Bulgarian adolescent smokers and to test predicted theoretical relationships with Stages of Change in the same population. Consistent with previous findings for other populations, a 3-factor model for Decisional Balance (CFI = .95) and a hierarchical 4-factor model for Temptations (CFI = .90) best fit the data. The predicted crossover pattern for Decisional Balance and a decreasing trend for Temptations across the Stages of Change were verified. Both measures demonstrated good levels of factorial invariance across gender and across random split-half cross-validation samples. These results support the cross-cultural validity of the TTM constructs and indicate that they can be used as a basis for development of interventions for the population under study.

Background/AimsCognitive impairment (CI) among hospitalized patients is associated with lack of functional recovery, rehospitalization, and death but limited data exists on CI in patients hospitalized for acute coronary syndromes (ACS). We examine the prevalence of, and factors associated with, CI among patients with an ACS.MethodsAdults (n = 623 to date) in central MA or Macon, GA without dementia or delirium were interviewed during hospitalization for an ACS as part of an ongoing study within the Transitions, Risk, and Actions in Coronary Events: Center for Outcomes Research and Education (TRACE-CORE). CI was indicated by a score =30 on the Telephone Interview of Cognitive Status (TICS; range = 0?41) Patients reported demographic and psychosocial factors: anxiety (GAD8; >4=high anxiety), depression (PHQ9; >4= high depressive symptoms), stress (PSS4; range 0?20), medication adherence (Morisky Scale), and health-related quality of life (SF-36). Patient characteristics were compared by CI status using chi-squared and t-tests.ResultsParticipants were 65% (405 of 623) male, 77% (479 of 623) non-Hispanic white and 14% (87 of 623) African-American, and aged 61.3?11.0 years. Thirty percent of patients hospitalized for ACS were cognitively impaired (187 of 623). In general, patients with CI were only mildly impaired (mean TICS = 28.4). Compared to patients who were cognitively intact, patients with CI were less educated (post high school: 69% vs. 85%) and were more likely to have high levels of depressive symptoms and anxiety (p?s