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Frailty is increasingly recognized as a salient condition in patients with heart failure (HF) as previous studies have determined that frailty is highly prevalent and prognostically significant, particularly in those with advanced HF. Definitions of frailty have included a variety of domains, including physical performance, sarcopenia, disability, comorbidity, and cognitive and psychological impairments, many of which are common in advanced HF. Multiple groups have recently recommended incorporating frailty assessments into clinical practice and research studies, indicating the need to standardize the definition and measurement of frailty in advanced HF. Therefore, the purpose of this consensus statement is to provide an integrated perspective on the definition of frailty in advanced HF and to generate a consensus on how to assess and manage frailty. We convened a group of HF clinicians and researchers who have expertise in frailty and related geriatric conditions in HF, and we focused on the patient with advanced HF. Herein, we provide an overview of frailty and how it has been applied in advanced HF (including potential mechanisms), present a definition of frailty, generate suggested assessments of frailty, provide guidance to differentiate frailty and related terms, and describe the assessment and management in advanced HF, including with surgical and nonsurgical interventions. We conclude by outlining critical evidence gaps, areas for future research, and clinical implementation., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Unplanned rehospitalizations occur frequently in older patients. Drug-related problems constitute a major and largely preventable cause with inappropriate prescribing being a substantial culprit. Solutions are needed to reduce this risk by targeting pharmacotherapy both during and after hospital stay. Therefore, we aim to perform a randomized controlled trial in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health-related outcomes., Methods/design: The study concerns a monocenter, non-blinded, randomized controlled trial that will take place at the acute geriatric wards of a large academic hospital. Patients being in a palliative stage with active therapy withdrawal or patients discharged to another ward within the same hospital or another hospital are excluded. In total, 828 patients will be randomized (1:1) to the usual care or intervention group. The multifaceted clinical pharmacy intervention comprises medication reconciliation at admission and discharge, medication review, patient/caregiver education, intensified communication with primary care providers and post-discharge follow-up, which also includes a telepharmacology service. The primary endpoint is defined as the time to an all-cause, unplanned hospital revisit within six months after discharge. Other health-related outcomes such as drug-related readmissions, quality of life and number of potentially inappropriate medications will be analyzed as secondary endpoints. Patient inclusion started in February 2021., Discussion: This study will provide useful insights regarding the impact of clinical pharmacy interventions on geriatric wards with the goal to optimize health-related outcomes such as hospital revisits., Trial Registration: ClinicalTrials.gov Identifier: NCT04617340., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Nonadherence to tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML) has been associated with inferior outcomes. Scarce evidence exists on the effectiveness of adherence-enhancing interventions. The present pilot study evaluated the feasibility and effectiveness of an intervention to improve TKI adherence in adult CML patients., Patients and Methods: Using a quasi-experimental pre-post intervention design, we included a convenience sample of 58 CML patients (median age, 60.5 years; interquartile range, 19) receiving TKI treatment in 4 hematology institutes in Israel (median previous treatment duration, 34 months; interquartile range, 60). Of the 58 patients, 36 (62%) were receiving first-line treatment. TKI adherence was assessed using electronic monitoring for 7 months (4 months for the baseline assessment and for 3 months after the intervention) and defined as the percentage of days with dosing taken as prescribed. The multilevel intervention combined training of health care workers and multiple behavioral change techniques (eg, motivational interviewing, feedback on electronic monitoring printouts, behavioral change techniques tailored to reasons for nonadherence). The baseline and postintervention adherence were compared using generalized estimating equation models., Results: The median baseline electronically monitored adherence (n = 55) was 97.5% (range, 48%-100%). The odds of taking the drug daily as prescribed were 58% greater after intervention (odds ratio, 1.58; 95% confidence interval [CI], 1.16-2.15). Adherence improved by only 1.5% overall (95% CI, 0.1%-2.8%) but by 8.5% (i.e. from 71.2% average adherence before intervention, to 79.6% after; P = .04) in a subgroup of 10 nonadherent patients (baseline adherence < 90%)., Conclusion: TKI adherence improved with our pilot intervention, mainly in patients with suboptimal baseline adherence., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: There are inconsistencies in reports on correlates for nonadherence (NA) to tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML). The diagnostic accuracy of subjective adherence measures using electronic monitoring (EM) as the reference standard is yet to be determined. This study aimed to evaluate correlates of TKI NA using EM and test the diagnostic accuracy of subjective adherence measures., Patients and Methods: CML patients receiving a TKI for any duration were enrolled at 4 hematology institutes, and adherence was measured for 4 months. EM adherence was the reference adherence measure, expressed as the percentage of days with the drug taken as prescribed. Subjective adherence was measured using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) self-report and clinician-reported visual analog scale (VAS) at 2 time points. Baseline theory-derived correlates of NA were identified using single and multiple regression analysis. The diagnostic accuracy of BAASIS and clinician-reported VAS was tested against an exploratory EM NA cutoff of < 95%., Results: The median EM adherence (n = 55) was 97.5% (range, 48-100%), while the 25th percentile was 92.1%. Lack of membership in a CML patient support group, living alone, and third-line treatment were associated with EM NA on multiple regression analysis. The BAASIS self-report (n = 94) had a sensitivity of 67% and a specificity of 71% for diagnosing NA, while clinician-reported VAS (n = 89) had a sensitivity of 78% and specificity of 42%., Conclusion: A quarter of patients had potentially clinically meaningful NA. These NA correlates and the BAASIS provide a basis for identifying nonadherent patients who can be targeted by interventions., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The psychosocial evaluation is well-recognized as an important component of the multifaceted assessment process to determine candidacy for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS). However, there is no consensus-based set of recommendations for either the full range of psychosocial domains to be assessed during the evaluation, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients' receipt of and response to interventions for any problems identified. This document provides recommendations on both evaluation content and process. It represents a collaborative effort of the International Society for Heart and Lung Transplantation (ISHLT) and the Academy of Psychosomatic Medicine, American Society of Transplantation, International Consortium of Circulatory Assist Clinicians, and Society for Transplant Social Workers. The Nursing, Health Science and Allied Health Council of the ISHLT organized a Writing Committee composed of international experts representing the ISHLT and the collaborating societies. This Committee synthesized expert opinion and conducted a comprehensive literature review to support the psychosocial evaluation content and process recommendations that were developed. The recommendations are intended to dovetail with current ISHLT guidelines and consensus statements for the selection of candidates for cardiothoracic transplantation and MCS implantation. Moreover, the recommendations are designed to promote consistency across programs in the performance of the psychosocial evaluation by proposing a core set of content domains and processes that can be expanded as needed to meet programs' unique needs and goals., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Factors at the level of family/healthcare worker, organization, and system are neglected in medication nonadherence research in heart transplantation (HTx). The 4-continent, 11-country cross-sectional Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation (BRIGHT) study used multistaged sampling to examine 36 HTx centers, including 36 HTx directors, 100 clinicians, and 1397 patients. Nonadherence to immunosuppressants-defined as any deviation in taking or timing adherence and/or dose reduction-was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale © (BAASIS © ) interview. Guided by the Integrative Model of Behavioral Prediction and Bronfenbrenner's ecological model, we analyzed factors at these multiple levels using sequential logistic regression analysis (6 blocks). The nonadherence prevalence was 34.1%. Six multilevel factors were associated independently (either positively or negatively) with nonadherence: patient level: barriers to taking immunosuppressants (odds ratio [OR]: 11.48); smoking (OR: 2.19); family/healthcare provider level: frequency of having someone to help patients read health-related materials (OR: 0.85); organization level: clinicians reporting nonadherent patients were targeted with adherence interventions (OR: 0.66); pickup of medications at physician's office (OR: 2.31); and policy level: monthly out-of-pocket costs for medication (OR: 1.16). Factors associated with nonadherence are evident at multiple levels. Improving medication nonadherence requires addressing not only the patient, but also family/healthcare provider, organization, and policy levels., (© 2017 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.)

Improving mid-term and long-term outcomes after solid organ transplantation is imperative, and requires both state-of-the-art transplant surgery and optimization of routine, evidence-based aftercare. This randomized, controlled trial assessed the effectiveness of standard aftercare versus telemedically supported case management, an innovative aftercare model, in 46 living-donor renal transplant recipients during the first posttransplant year. The model includes three components: (i) chronic care case management initiated after discharge, (ii) case management initiated in emerging acute care situations, and (iii) a telemedically equipped team comprising a transplant nurse case manager and two senior transplant physicians (nephrologist, surgeon). Analyses revealed a reduction of unplanned inpatient acute care, with considerable cost reductions, in the intervention group. The prevalence of nonadherence over the 1-year study period was 17.4% in the intervention group versus 56.5% in the standard aftercare group (p = 0.013). Only the intervention group achieved their pre-agreed levels of adherence, disease-specific quality of life, and return to employment. This comparative effectiveness study provides the basis for multicenter study testing of telemedically supported case management with the aim of optimizing posttransplant aftercare. The trial was registered with the German Clinical Trials Register (www.DRKS.de), DKRS00007634., (© 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Well-designed randomized controlled trials (RCTs) testing efficacy of post-transplant medication adherence enhancing interventions and clinical outcomes are scarce., Methods: This randomized controlled trial enrolled adult heart, liver, and lung transplant recipients who were >1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3-month run-in period, patients were randomly assigned 1:1 to intervention group (IG) or control group (CG) (visit 2), followed by a 6-month intervention (visits 2-4) and a 6-month adherence follow-up period (visit 5). All patients used electronic monitoring for 15 months for adherence measurement, generating a daily binary adherence score per patient. Post-intervention 5-year clinical event-free survival (mortality or retransplantation) was evaluated. The IG received staged multicomponent tailored behavioral interventions (visits 2-4) building on social cognitive theory and trans-theoretical model (e.g., electronic monitoring feedback, motivational interviewing). The CG received usual care and attended visits 1-5 only. Intention-to-treat analysis used generalized estimating equation modeling and Kaplan-Meier survival analysis., Results: Of 247 patients, 205 were randomly assigned (103 IG, 102 CG). At baseline, average daily proportions of patients with correct dosing (82.6% IG, 78.4% CG) and timing adherence (75.8% IG, 72.2% CG) were comparable. The IG had a 16% higher dosing adherence post-intervention (95.1% IG, 79.1% CG; p < 0.001), resulting in odds of adherence being 5 times higher in the IG than in the CG (odds ratio 5.17, 95% confidence interval 2.86-9.38). This effect was sustained at end of follow-up (similar results for timing adherence). In the IG, 5-year clinical event-free survival was 82.5% vs 72.5% in the CG (p = 0.18)., Conclusion: Our intervention was efficacious in improving adherence and sustainable. Further research should investigate clinical impact, cost-effectiveness, and scalability., (Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Health literacy (HL) is a major determinant of health outcomes; however, there are few studies exploring the role of HL among heart transplant recipients. The objectives of this study were to: (1) explore and compare the prevalence of inadequate HL among heart transplant recipients internationally; (2) determine the correlates of HL; and (3) assess the relationship between HL and health-related behaviors., Methods: A secondary analysis was conducted using data of the 1,365 adult patients from the BRIGHT study, an international multicenter, cross-sectional study that surveyed heart transplant recipients across 11 countries and 4 continents. Using the Subjective Health Literacy Screener, inadequate HL was operationalized as being confident in filling out medical forms none/a little/some of the time (HL score of 0 to 2). Correlates of HL were determined using backward stepwise logistic regression. The relationship between HL and the health-related behaviors were examined using hierarchical logistic regression., Results: Overall, 33.1% of the heart transplant recipients had inadequate HL. Lower education level (adjusted odds ratio [AOR] 0.24, p < 0.001), unemployment (AOR 0.69, p = 0.012) and country (residing in Brazil, AOR 0.25, p < 0.001) were shown to be associated with inadequate HL. Heart transplant recipients with adequate HL had higher odds of engaging in sufficient physical activity (AOR 1.6, p = 0.016). HL was not significantly associated with the other health behaviors., Conclusions: Clinicians should recognize that almost one third of heart transplant participants have inadequate health literacy. Furthermore, they should adopt communication strategies that could mitigate the potential negative impact of inadequate HL., (Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: There is increasing emphasis on promoting "homelike" residential care models enabling care-dependent people to continue living in a self-determined manner. Yet, little is known about the outcomes of homelike residential care models., Purpose: We aimed to (1) identify homelike residential care models for older care-dependent people with and without dementia, and (2) explore the impact of these models on resident-, family-, and staff-related outcomes., Design and Methods: We applied a scoping review method and conducted a comprehensive literature search in PubMed, Embase, and CINAHL in May 2015., Results: We included 14 studies, reported in 21 articles. Studies were conducted between 1994 and 2014, most using a quasi-experimental design and comparing the Eden Alternative (n = 5), nondementia-specific small houses (eg Green House homes) (n = 2), and dementia-specific small houses (n = 7) with usual care in traditional nursing homes. The studies revealed evidence of benefit related to physical functioning of residents living in dementia-specific small houses and satisfaction with care of residents living in nondementia-specific small houses compared with those living in traditional nursing homes. We did not find other significant benefits related to physical and psychosocial outcomes of residents, or in family- and staff-related outcomes., Implications: The current evidence on homelike residential care models is limited. Comparative-effectiveness research building on a clear theoretical framework and/or logic model and including a standardized set of resident-, family-, and staff-related outcomes, as well as cost evaluation, is needed to provide a stronger evidence base to justify the uptake of more homelike residential care models., (Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Nonadherence to antihypertensive medicines limits their effectiveness, increases the risk of adverse health outcome, and is associated with significant health care costs. The multiple causes of nonadherence differ both within and between patients and are influenced by patients' care settings., Objectives: The objective of this article was to identify determinants of patient nonadherence to antihypertensive medicines, drawing from psychosocial and economic models of behavior., Methods: Outpatients with hypertension from Austria, Belgium, England, Germany, Greece, Hungary, The Netherlands, Poland, and Wales were recruited to a cross-sectional online survey. Nonadherence to medicines was assessed using the Morisky Medication Adherence Scale (primary outcome) and the Medication Adherence Rating Scale. Associations with adherence and nonadherence were tested for demographic, clinical, and psychosocial factors., Results: A total of 2595 patients completed the questionnaire. The percentage of patients classed as nonadherent ranged from 24% in The Netherlands to 70% in Hungary. Low age, low self-efficacy, and respondents' perceptions of their illness and cost-related barriers were associated with nonadherence measured on the Morisky Medication Adherence Scale across several countries. In multilevel, multivariate analysis, low self-efficacy (odds ratio = 0.73; 95% confidence interval 0.70-0.77) and a high number of perceived barriers to taking medicines (odds ratio = 1.70; 95% confidence interval 1.38-2.09) were the main significant determinants of nonadherence. Country differences explained 11% of the variance in nonadherence., Conclusions: Among the variables measured, patients' adherence to antihypertensive medicines is influenced primarily by their self-efficacy, illness beliefs, and perceived barriers. These should be targets for interventions for improving adherence, as should an appreciation of differences among the countries in which they are being delivered., (Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Context: Cancer pain continues to be extensively undertreated, despite established guidelines. Although the efficacy of interventions that support patients' self-management of cancer pain has been demonstrated in several studies, the most effective components of these interventions remain unknown., Objectives: The purpose of this review of experimental and quasi-experimental studies was to systematically describe the structure and content components, as well as the efficacy of various components, of interventions designed to improve patients' self-management of cancer pain., Methods: A systematic review of the literature was done that supplemented the 2009 meta-analysis of Bennett et al. Intervention components were categorized using content analysis. The intervention components were compared based on their calculated largest effect sizes (ESs) within each study (i.e., Hedges G(u) for between-group differences in pain intensity scores)., Results: Based on 34 publications (i.e., 24 interventions), seven structure and 16 content components were identified. In 11 studies with statistically significant ESs, the largest ES within each study ranged from -1.87 to -0.44, which represented clinically meaningful effects. No single component was found to have a discernable influence on ES., Conclusion: This analysis provides researchers and clinicians with a detailed overview of the various structural and content components, as well as various combinations that were tested in intervention studies to improve cancer pain management. However, because of a variety of limitations, the most efficacious intervention components or combination of components remain to be determined in future studies., (Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Imatinib mesylate (imatinib) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia (CML). Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong, patient adherence is critical. The ADAGIO (Adherence Assessment with Glivec: Indicators and Outcomes) study aimed to assess prospectively over a 90-day period the prevalence of imatinib nonadherence in patients with CML; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence; and to examine whether treatment response is associated with adherence levels. A total of 202 patients were recruited from 34 centers in Belgium, of whom 169 were evaluable. One-third of patients were considered to be nonadherent. Only 14.2% of patients were perfectly adherent with 100% of prescribed imatinib taken. On average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken (23.2%, standard deviation [SD] = 23.8) than did those with optimal response (7.3%, SD = 19.3, P = .005; percentages calculated as proportions x 100). Nonadherence is more prevalent than patients, physicians, and family members believe it is, and therefore should be assessed routinely. It is associated with poorer response to imatinib. Several determinants may serve as alert signals, many of which are clinically modifiable.

This report is a summary of a 'Consensus Conference' on nonadherence (NA) to immunosuppressants. Its aims were: (1) to discuss the state-of-the-art on the definition, prevalence and measurement of NA, its risk factors and impact on clinical and economical outcomes and interventions and (2) to provide recommendations for future studies. A two-day meeting was held in Florida in January 2008, inviting 66 medical and allied health adherence transplant and nontransplant experts. A scientific committee prepared the meeting. Consensus was reached using plenary and interactive presentations and discussions in small break-out groups. Plenary presenters prepared a summary beforehand. Break-out group leaders initiated discussion between the group members prior to the meeting using conference calls and e-mail and provided a summary afterward. Conclusions were that NA: (a) is more prevalent than we assume; (b) is hard to measure accurately; (c) tends to confer worse outcomes; (d) happens for a number of reasons, and system-related factors including the patient's culture, the healthcare provider and the setting and (e) it is not currently known how to improve adherence. This consensus report provided some roadmaps for future studies on this complicated, multifaceted problem.

Objective: To test content validity and usability of the Organ Transplant Information System (OTIS)., Methods: This study used qualitative methods. The purposive sample consisted of 8 clinicians and 14 patients. Clinicians rated the content's congruence with current medical practice. We used the clinicians' evaluations to revise the OTIS content; then each patient evaluated the revised OTIS modules using the thinking-aloud method and via structured interviews. Descriptive statistics were applied for demographic and clinical data, and for the clinicians' ratings. Content data usability and validity were analyzed using Content Analysis., Results: Clinicians identified deviations from current medical practice regarding content, language, and information structure of OTIS. Seven rated OTIS as non-relevant for implementation into clinical practice. Five rated the program's content--with the stipulated adaptations--as important for patients. All patients encountered usability problems, mostly regarding the program's interface. Emerging categories from the patients' perspectives vis à vis content were knowledge acquisition, illness management, and partnership forming., Conclusion: Problems arose regarding OTIS's initial content validity and usability, demonstrating the need to establish the presented material's content validity and usability by involving clinicians and patients before its clinical implementation., Practice Implications: High quality computer-learning-software is needed to enhance patient self-management.

Valid assessment of immunosuppressive therapy non-adherence (NAH) is vital: NAH is associated with negative transplantation outcomes. We studied the diagnostic accuracy of assay, patient self-reports and clinicians' collateral reports and composite adherence scores using electronic monitoring (EM) as a reference standard. This cross-sectional study included a convenience sample of 249 adult kidney transplant recipients (Ktx) (female: 43.4%; mean age 53.6 [SD: 12.7], median 7 years [IQR: 9 years] post-Ktx). NAH was assessed using EM over 3 months (i.e. reference standard), assays of cyclosporine, tacrolimus, mycophenolat-mofetil, patients' self-reports and clinicians' collateral reports. The constructed composite adherence score included assay, self-reports and collateral reports. NAH's prevalence across the measurement methods was EM: 17.3%; assay: 33% (cyclosporine: 25.8%; tacrolimus: 35.1%; mycophenolat-mofetil: 40.2%); self-report: 12.4%; collateral reports: 24.9% and composite adherence score: 38.9%, respectively. The composite adherence score and collateral reports showed the highest and lowest sensitivities to NAH (72.1% and 15.8%, respectively). Specificity was highest for collateral reports of at least three clinicians (93.1%). Likelihood ratio of a positive test was 2.74 for composite adherence score. No measures showed high sensitivity alongside high specificity. Combining measures increased diagnostic accuracy, indicating the relevance of combined measures for clinical and research purposes.

Background: Although sexual problems in cardiac patients are receiving increasing attention, research on sexual functioning of patients with congenital heart disease is very scarce. Therefore, this study investigated sexual functioning in adults with congenital heart disease and compared this with that of matched, healthy control subjects., Methods: A descriptive, comparative study was conducted, in which 441 adults with congenital heart disease were matched to 441 healthy counterparts, according to age, gender, and marital status. The sample consisted of 53.5% males. Median age was 24 years. Disease-specific determinants of quality of life were assessed using the CHD-TAAQOL. This 77-item instrument includes five items referring to sexual problems. For each item, both the perceived frequency and the associated distress were scored., Results: Sexual problems were perceived by 10% to 20% of the patients. When these problems occurred, they were distressing in 67% to 88% of the patients. Female patients reported significantly more often 'not enjoying having sex', 'being insecure about having sex', and 'not being aroused while having sex', and experienced more distress at 'being insecure about having sex' than male patients. Congenital heart disease patients reported significantly fewer 'not enjoying having sex' and 'worrying about your sex life' than healthy counterparts, but experienced more distress at 'worrying about your sex life'., Conclusion: In this study, we found that only a minority of adults with congenital heart disease reported sexual problems. This suggests that sexual functioning in this group of patients is not as problematic as in some other cardiac populations.

Non-adherence with immunosuppressive regimen is a major risk factor for poor outcome after kidney transplantation. Identifying patients at risk for non-adherence requires understanding the risk factors for non-adherence. This prospective study included a convenience sample of 249 adult kidney transplant patients >1 year post-transplant. Non-adherence was monitored electronically using MEMS(R). Selected socio-economic, therapy-, patient-, condition- and healthcare team-related risk factors for non-adherence were assessed. Period prevalences were expressed as the percent of prescribed doses taken (taking adherence), the percent of correctly dosed days (dosing adherence), the percentage of inter-dose intervals not exceeding 25% of the prescribed interval (timing adherence), and the number of drug holidays per 100 days (no intake for > 48 h if once daily or for > 24 h if twice daily intake). Testing occurred by simple mixed logistic regression analysis. Factors significant after correction for multiple testing were entered into a multiple logistic regression model. Mean taking, dosing, timing adherence, and drug holidays were 98%, 96%, 93%, and 1.1 days, respectively. Non-adherence was associated with lower self-efficacy, higher self-reported non-adherence, no pillbox usage, and male gender. Adherence declined between Monday and Sunday. This study provides a framework for identifying patients at risk for non-adherence and for developing adherence-enhancing interventions.

Cardiothoracic transplantation's success at prolonging life--and its economic costs--must be considered relative to its psychosocial benefits and costs. Moreover, psychosocial outcomes themselves influence long-term post-transplant morbidity and mortality rates. Although psychosocial outcomes--encompassing patients' physical, psychologic and social functioning, their management of their medical regimen and global quality of life--are the focus of many recent studies, these investigations have yet to yield many evidence-based interventions that are routinely applied to improve patient outcomes. Our goals were to summarize existing work on psychosocial outcomes, delineate areas requiring attention, offer recommendations for steps to advance the field, and thereby provide an impetus for the conduct of clinical trials of interventions to improve these outcomes. We concluded that research must generally shift away from descriptive studies and toward prospective and clinical trial designs to: (a) examine a full range of risk factors and clinical sequelae of patients' psychosocial status; and (b) evaluate the effectiveness of psychosocial interventions. In addition, these issues must be considered across all cardiothoracic recipients, including not only heart recipients but the less-studied populations of lung and heart-lung recipients, and must include longer-term (5+ years) outcomes than is typical in most work. The importance of adequately sized samples to ensure statistical power, and the need to construct study samples representative of the larger cardiothoracic transplant population, cannot be overestimated. Implementing these changes in research design and substantive focus will ensure that psychosocial outcomes research will have maximum impact on transplant recipients' clinical care.

Background: Although non-compliance with immunosuppression therapy is increasingly recognized as a risk factor for morbidity and mortality after heart transplantation (HTX), evidence for this association is limited to 1 prospective study that assessed medication non-compliance in the early post-HTX period and used self-report. The current prospective HTX cohort study explores the predictive value of late non-compliance (>1 year after HTX) during a 5-year follow-up using the Medication Event Monitoring System (MEMS) for compliance assessment., Methods: We categorized 101 patients (86% men; aged 55 +/- 10 years; time after HTX at inclusion, 1,253 +/- 534 days) as medication non-compliers (n = 17) or compliers (n = 84) based on the MEMS. Late acute rejections, transplant coronary artery disease (TxCAD), retransplantation, and death were registered during the 5-year follow-up., Results: Non-compliers had significantly more TxCAD (p = 0.025). Non-compliers also had a greater rate of late acute rejection (11.8% vs 2.4%) and retransplantation (13.3% vs 2.5%)), although these differences were not statistically significant. Mortality rates were similar. Kaplan Meier analysis showed that non-compliers had a significantly shorter clinical-event-free time compared with compliers (mean, 1,318 vs 1,612 days; p = 0.043). Cox regression analysis showed that the adjusted relative risk associated with non-compliance was 2.03 (p = 0.0582), after controlling for other known transplant-related risk factors for poor clinical outcome., Conclusion: The current study demonstrates that medication non-compliance in the late post-transplant period doubles the risk for an untoward clinical event. Non-compliance is a continuous risk factor after heart transplantation that should be targeted by compliance-enhancing interventions.

Objectives: Cost-utility analysis in renal transplant populations requires the use of a generic instrument for health status measurement that generates a single value for health. Such instruments should be widely applicable in diverse patient populations and their validity should be established. The aim of this study was to explore the validity of the EQ-5D in renal transplant patients., Methods: The EQ-5D was compared with the Short-Form 36 Health Survey (SF-36), the modified transplant symptom occurrence and symptom distress (MTSOSD) scale, the short-form Beck Depression Inventory (BDI), and the State Trait Anxiety Inventory (STAI). Construct and concurrent validity were tested on cross-sectional data of 350 patients., Results: Construct validity is good for some but not all EQ-5D dimensions, and the EQ-5D discriminates well among groups of patients with different health states according to the SF-36, MTSOSD scale, BDI, and STAI and between patients and the general public. Concurrent validity is good, as shown by the correspondence of EQ-5D and SF-36 results., Conclusion: It is concluded that the EQ-5D is a valid instrument for the measurement of health status in renal transplant patients.

Background: Although noncompliance with immunosuppressive medication is recognized as a critical behavioral risk factor for late acute rejection episodes and graft loss after transplantation, little is known about the degree of subclinical cyclosporine noncompliance, its associated risk for acute late rejection episodes (>1 year after transplantation), and its determinants in heart transplant recipients., Methods: The convenience sample of this longitudinal study included 101 European heart transplant recipients (87 men and 14 women), with a median age of 56 (Q1 = 50, Q3 = 61) and a median posttransplantation status of 3 (range 1 to 6) years. Subclinical cyclosporine noncompliance was measured during a 3-month period with electronic event monitoring. Selected sociodemographic, behavioral, cognitive, emotional, health, and treatment-related determinants of medication noncompliance were measured by using instruments with established psychometric properties or by patient interviews. With the use of iterative partitioning methods of cluster analysis, including nonstandardized electronic event monitoring compliance parameters, patients were categorized by degree of subclinical cyclosporine noncompliance into a 3-cluster solution., Results: Overall compliance was high, with a median medication taking compliance of 99.4%. The 3 derived clusters, that is, excellent compliers (84%), minor subclinical noncompliers (7%), and moderate subclinical noncompliers (9%), differed significantly by degree of subclinical noncompliance (p < .0001) and showed a 1.19%, 14.28%, and 22.22% incidence of late acute rejections (p = .01), respectively. The 3 groups also differed in terms of former medication noncompliance (p = .02), appointment noncompliance (p = .03), and perceived self-efficacy with medication taking (p = .04)., Conclusions: Although in absolute numbers cyclosporine compliance in this sample was high, minor deviations from dosing schedule were associated with an increased risk for acute late rejection episodes. This suggests a pivotal role of patient compliance in successful long-term outcome after transplantation.

Background: This study details the hospital costs of strict reverse isolation procedures in heart transplant recipients., Methods: In a prospective, descriptive design, a research protocol was developed, identifying all of the activities related to strict reverse isolation procedures in heart transplant recipients. For each separate activity, materials used and workload were registered, which allowed the calculation of the material and labor costs for each of the isolation procedures., Results: The cost calculations show that the first day in isolation costs about $160 (for isolation procedures only) and about $65 for each consecutive isolation day. With a mean post-intensive care unit length of stay of 22 days, the mean cost of isolation procedures for heart transplant recipients amounts to $1535. Finally, a modified isolation protocol was developed, incorporating only those procedures with proven effectiveness. It was calculated that a switch to such a modified protocol would allow a savings of over 50% of the hospital resources devoted to isolation measures., Conclusions: Isolation procedures use a significant portion of hospital resources. Modifying isolation protocols in heart transplant recipients can be a source of considerable savings in a transplant program.