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Background: Nonadherence to immunosuppressives, a risk factor for poor posttransplant outcomes, can be assessed by self-report using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS). Available in written and interview versions, and previously validated on content, the BAASIS is widely used in research and clinical practice. The aim of this study was to investigate its psychometric properties., Methods: Using a literature search and our BAASIS database, this meta-analysis identified completed studies in adult transplant recipients whose data were usable to examine the BAASIS' reliability and 3 validity aspects: (1) relationships with other variables (electronic monitoring, other self-report scales, tacrolimus blood-level variability, collateral report, depressive symptoms, psycho-behavioral constructs, and interventions); (2) response processes; and (3) internal structure. Testing used random-effects logistic regressions., Results: Our sample included 12 109 graft recipients from 26 studies. Of these 26, a total of 20 provided individual participant data. Evidence of the BAASIS' stability over time supports its reliability. Validity testing of relationships with other variables showed that BAASIS-assessed nonadherence was significantly associated with the selected variables: electronically monitored nonadherence ( P < 0.03), other self- and collaterally-reported nonadherence ( P < 0.001), higher variability in tacrolimus concentrations ( P = 0.02), higher barriers ( P < 0.001), lower self-efficacy ( P < 0.001), lower intention ( P < 0.001), and higher worries ( P = 0.02). Nonadherence also decreased after regimen change interventions ( P = 0.03). Response process evaluation indicated good readability and slightly higher nonadherence with the written version. Structurally, items on taking and timing shared variability., Conclusions: The BAASIS shows good validity and reliability as a self-report instrument to assess medication nonadherence in transplantation., Competing Interests: S.D.G. consults for Sanofi and Novartis—activities unrelated to the current work. The other authors declare no conflicts of interest. The BAASIS is copyright the University of Basel (Switzerland) but is freely available for academic and clinical purposes after registration on the BAASIS website ( https://baasis.nursing.unibas.ch/ )., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Competing Interests: The authors declare no funding or conflicts of interest.

Background: Immunosuppressive nonadherence is a risk factor for worse outcomes after kidney transplantation (KT). Brazil, having the world's largest public, fully covered transplantation system and the second-highest KT volume worldwide, provides a unique setting for studying multilevel correlates of nonadherence (patient, healthcare provider, transplant center, and healthcare system levels) independent of patients' financial burden., Methods: By applying a multistage sampling approach, we included 1105 patients from 20 KT centers. Nonadherence to immunosuppressives (implementation phase) was defined as any deviation in taking or timing adherence and dose reduction assessed by the Basel Assessment of Adherence to Immunosuppressive Medications Scale. Based on Bronfenbrenner's ecological model, we assessed multilevel factors using established instruments and measures specifically developed for this study and analyzed their independent contribution to nonadherence by performing sequential logistic regression analysis., Results: The nonadherence prevalence rate was 39.7%. The following factors were independently associated with nonadherence: Patient level-having a stable partner (odds ratio [OR]: 0.75; confidence interval [CI]: 0.58-0.97), nonadherence to appointments (OR: 2.98; CI: 2.03-4.39), and nonadherence to physical activity recommendations (OR: 1.84; CI: 1.38-2.46); and transplant center level-satisfaction with the waiting room structure (OR: 0.54; CI: 0.42-0.71), consultation >30 minutes (OR: 1.60; CI: 1.19-2.14), adequacy of the consultation frequency (OR: 0.62; CI: 0.43-0.90), and centers with >500 beds (OR: 0.58; CI: 0.46-0.73)., Conclusions: As the first multicenter study assessing multilevel correlates of nonadherence in KT, our findings point to the need for multilevel interventions beyond the patient level, targeting transplant center practice patterns as an approach to tackle nonadherence., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Weight gain and obesity are well-known clinical issues in liver transplantation (LTx). However, their impacts on patient outcomes remain unclear, as only the impact of pre-LTx body mass index (BMI) on survival has been meta-analyzed. We summarized and synthesized the evidence on pre- and post-LTx body weight parameters' relations with post-LTx outcomes such as survival, metabolic and cardiovascular comorbidities, and healthcare utilization., Methods: We followed the Cochrane Handbook for Systematic Reviews of Interventions' recommendations. Quality was assessed via a 19-item instrument. Odds ratios and 95% confidence intervals were calculated for outcomes investigated in ≥5 studies., Results: Our meta-analysis included 37 studies. Patients with pre-LTx BMI ≥ 30 kg/m and BMI ≥ 35 kg/m had lower overall survival rates than those with pre-LTx normal weight (72.6% and 69.8% versus 84.2%; P = 0.02 and P = 0.03, respectively). Those with pre-LTx BMI ≥ 30 kg/m had worse overall graft survival than normal weight patients (75.8% and 85.4%; P = 0.003). Pre-LTx BMI and pre-LTx overweight were associated with new-onset diabetes (P < 0.001 and P = 0.015, respectively), but post-LTx BMI showed no relationship. No associations were evident with healthcare utilization., Conclusions: Patients with BMI values ≥30 kg/m had worse patient and graft survival than those with normal weight. Few of the reviewed studies examined post-LTx body weight parameters or other relevant outcomes such as cardiovascular comorbidities. High heterogeneity as well as diverse definitions and operationalizations of measurement and outcomes severely impeded comparability.

Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes.COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group's remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant.The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting.

Background: Despite smoking being an absolute or relative contraindication for transplantation, about 11% to 40% of all patients continue or resume smoking posttransplant. This systematic review with meta-analysis investigated the correlates and outcomes associated with smoking after solid organ transplantation., Methods: We searched PubMed, EMBASE, CINAHL, and PsycINFO from inception until January 2016, using state-of-the art methodology. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were computed for correlates/outcomes investigated 5 times or more., Results: Seventy-three studies (43 in kidney, 17 in heart, 12 in liver, 1 in lung transplantation) investigated 95 correlates and 24 outcomes, of which 6 correlates and 4 outcomes could be included in the meta-analysis. The odds of smoking posttransplant were 1.33 times higher in men (95% CI, 1.12-1.57). Older individuals were significantly less likely to smoke (OR, 0.48; 95% CI, 0.38-0.62), as were patients with a higher body mass index (OR, 0.68; 95% CI, 0.52-0.89). Hypertension (OR, 1.16; 95% CI, 0.77-1.75), diabetes mellitus (OR, 0.52; 95% CI, 0.15-1.78), and having a history of cardiovascular disease (OR, 0.92; 95% CI, 0.77-1.09) were not significant correlates. Posttransplant smokers had higher odds of newly developed posttransplant cardiovascular disease (OR, 1.41; 95% CI, 1.02-1.95), nonskin malignancies (OR, 2.58; 95% CI, 1.26-5.29), a shorter patient survival time (OR, 0.59; 95% CI, 0.44-0.79), and higher odds of mortality (OR, 1.74; 95% CI, 1.21-2.48)., Conclusions: Posttransplant smoking is associated with poor outcomes. Our results might help clinicians to understand which patients are more likely to smoke posttransplant, guide interventional approaches, and provide recommendations for future research.

Background: This open-label single-arm exploratory study evaluated the accuracy of the Ingestible Sensor System (ISS), a novel technology for directly assessing the ingestion of oral medications and treatment adherence., Methods: ISS consists of an ingestible event marker (IEM), a microsensor that becomes activated in gastric fluid, and an adhesive personal monitor (APM) that detects IEM activation. In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS). Twenty stable adult kidney transplants received IEM-ECMPS for a mean of 9.2 weeks totaling 1227 cumulative days., Results: Eight patients prematurely discontinued treatment due to ECMPS gastrointestinal symptoms (n=2), skin intolerance to APM (n=2), and insufficient system usability (n=4). Rash or erythema due to APM was reported in 7 (37%) patients, all during the first month of use. No serious or severe adverse events and no rejection episode were reported. IEM detection accuracy was 100% over 34 directly observed ingestions; Taking Adherence was 99.4% over a total of 2824 prescribed IEM-ECMPS ingestions. ISS could detect accurately the ingestion of two IEM-ECMPS capsules taken at the same time (detection rate of 99.3%, n=2376)., Conclusions: ISS is a promising new technology that provides highly reliable measurements of intake and timing of intake of drugs that are combined with the IEM.

Introduction: Nonadherence to immunosuppressive therapy is recognized as a key prognostic indicator for poor posttransplantation long-term outcomes. Several methods aiming to measure medication nonadherence have been suggested in the literature. Although combining measurement methods is regarded as the gold standard for measuring nonadherence, self-report is generally considered a central component of adherence assessment. However, no systematic review currently exists to determine which instrument(s) are most appropriate for use in transplant populations., Methodology: The transplant360 Task Force first performed a survey of the self-report adherence instruments currently used in European centers. Next, a systematic literature review of self-report instruments assessing medication adherence in chronically ill patients was conducted. Self-report instruments were evaluated to assess those which were: (a) short and easy to score; (b) assessed both the taking and timing of medication intake; and (c) had established reliability and validity., Results: Fourteen instruments were identified from our survey of European centers, of which the Basel Assessment of Adherence Scale for Immunosuppressives met the aforementioned criteria. The systematic review found 20 self-report instruments, of which only two qualified for use in transplantation, that is, the Brief Antiretroviral Adherence Index and the Medication Adherence Self-Report Inventory., Discussion: The three selected self-report scales may assist transplant professionals in detecting nonadherence. However, these scales were only validated in patients with HIV. Although HIV shares similar characteristics with transplantation, including the importance of taking and timing of medication, further validation in transplant populations is required.

Introduction: There is growing awareness, yet scant prospective evidence that pretransplant (TX) psychosocial factors may predict post-TX outcome. We examined which pre-TX psychosocial factors predict post-TX nonadherence with immunosuppression (NA) and clinical outcomes in heart, liver, and lung TX., Methodology: We prospectively followed 141 patients (28 heart, 61 liver, and 52 lung) from pre-TX until 1 year post-TX. Multivariable analyses determined which pre-TX factors (i.e., anxiety, depression, personality traits, social support, adherence with medication, and smoking status) predict poor post-TX outcome (i.e., NA, late acute rejection, graft loss, and resource utilization), controlling for medical predictors of poor outcome., Results: Pre-TX self-reported medication nonadherence (odds ratio [OR]=7.9), lower received social support (OR=0.9), a higher education (OR=2.7), and lower "conscientiousness" (OR=0.8) were independent predictors of post-TX NA. Not living in a stable relationship predicted graft loss (OR=4.9). Pre-TX medication NA was the only predictor for presence of late acute rejection (OR=4.4). No other pre-TX predictors for poor outcome could be found., Conclusion: This is the first prospective study demonstrating that selected pre-TX psychosocial factors predict post-TX NA and poor clinical outcome, implying that pre-TX screening should include this set of factors in addition to traditional medical criteria.

Background: Despite the importance of adherence to the medical regimen for maximizing health after lung transplantation, no prospective studies report on rates or risk factors for nonadherence in this patient population. Whether adherence levels differ in lung versus other types of transplant recipients is unknown., Methods: A total of 178 lung recipients and a comparison group of 126 heart recipients were enrolled. Adherence in nine areas was assessed in separate patient and family caregiver interviews 2, 7, 12, 18, and 24 months posttransplant. Potential risk factors for nonadherence were obtained at the initial assessment., Results: Cumulative incidence rates of persistent nonadherence (i.e., nonadherence at > or =2 consecutive assessments) were significantly lower (P<0.05) in lung recipients than heart recipients for taking immunosuppressants (13% nonadherent vs. 21%, respectively), diet (34% vs. 56%), and smoking (1% vs. 8%). Lung recipients had significantly higher persistent nonadherence to completing blood work (28% vs. 17%) and monitoring blood pressure (70% vs. 59%). They had a high rate of spirometry nonadherence (62%; not measured in heart recipients). The groups did not differ in nonadherence to attending clinic appointments (27%), exercise (44%), or alcohol limitations (7%). In both groups, poor caregiver support and having only public insurance (e.g., Medicaid) increased nonadherence risk in all areas., Conclusions: Lung recipients were neither uniformly better nor worse than heart recipients in adhering to their regimen. Lung recipients have particular difficulty with some home monitoring activities. Strategies to maximize adherence in both groups should build on caregiver support and on strengthening financial resources for patient healthcare requirements.

Background: Evidence on prevalence and correlates of pretransplant medication nonadherence (MNA) is limited. The present study explored self-reported prevalence and correlates of MNA before heart, liver, and lung transplantation., Methods: This cross-sectional descriptive study included 174 patients: 69 lung, 33 heart, and 72 liver transplant candidates. MNA was assessed by self-report using the following question: "During the past 14 days, how often did you not take your medication?" Patients scoring once or higher on a five-point rating scale were considered to be nonadherent. Correlates of MNA explored were demographics, anxiety and depression (Hospital Anxiety and Depression Inventory), personality traits (NEO Personality Inventory-Revised), perceived health status (Euro-QOL), and social support (Social Support Questionnaire)., Results: Prevalence of pretransplant MNA was 16.7% and was comparable among the three groups. After correction for multiple comparisons (i.e., P=0.01), higher educational level (P=0.006) was related to MNA. Less severe depression (P=0.069), lower scores on the personality trait conscientiousness (P=0.021), and less received social support (P=0.062) tended to be related to MNA. Multiple logistic regression revealed that higher educational level (P=0.008), lower received social support (P=0.013), and lower conscientiousness (P=0.023) were independent predictors of pretransplant MNA., Conclusions: Several correlates of MNA allow identification of patients at risk for pretransplant MNA.

Background: Renal transplantation is frequently considered superior to other renal replacement therapy in terms of survival and quality-of-life outcome. In this study, it was examined whether physicians and nurses have accurate perceptions of health status after renal transplantation (RTX) and whether renal transplant candidates have realistic expectations about posttransplant quality of life., Methods: A comparative descriptive design was used for the comparison of physicians' and nurses' perceived and patients' expected and actual health status after RTX. Health status perceptions were measured by means of the EQ-5D self-report questionnaire. RTX candidates (n=107) were followed longitudinally from November 1999 until July 2001. Transplant patients (n=29) were surveyed 14 days and 4, 8, and 12 months after discharge from hospital. All physicians and nurses (n=123) had regular contact with dialysis or RTX patients., Results: Physicians' and nurses' perceptions of health status after RTX were significantly lower than patients' expectations. Transplant nurses' and physicians' valuations were closer to patients' actual health status after transplantation than valuations of nurses on the dialysis or nephrology ward or at the outpatient clinic., Conclusions: RTX candidates frequently have higher expectations about their quality of life after transplantation than physicians and nurses who have regular contact with renal transplant patients. Physicians' and nurses' perceptions are closer to the actual health state after transplantation than patients' expectations. Thus, physicians and nurses are a reliable source of information for patients about the health state they can expect after transplantation.

In this descriptive cross-sectional study, we investigated the incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in 150 adult renal transplant recipients with more than one year posttransplant status. Symptom frequency and symptom distress, and self-care agency were measured by the Transplant Symptom Frequency and Symptom Distress Scale, and the Appraisal for Self-Care Agency Scale, respectively. The Long-Term Medication Behavior Self-Efficacy Scale and a renal transplant knowledge questionnaire were developed as part of this study to measure perceived self-efficacy and knowledge of the therapeutic regimen. Demographic variables were also measured. The incidence of subclinical noncompliance with immunosuppressive therapy as assessed by interview was 22.3%. Compliers and noncompliers differed significantly on the variables of marital status (P = 0.03), situational-operational knowledge (P = 0.02), self-care agency (P = 0.03), and perceived self-efficacy related to long-term medication intake (P = 0.048). A logistic regression model using gender, marital status, perceived self-efficacy, self-care agency, knowledge about medication administration and signs of infection, and situational operational knowledge as predictor variables, revealed a 78.6% correct classification of compliers versus noncompliers and a sensitivity ratio of 95.9%. There were significantly more acute late rejection episodes (P = 0.003) in the noncompliant group. Graft survival at 5 years in this group was also significantly lower (P = 0.03) than the compliant patients. No significant difference was found in terms of the occurrence of chronic rejection episodes or in terms of patient survival at 5 years. Because noncompliance is a risk factor for negative clinical outcome in renal transplant recipients, it is of utmost importance to develop intervention strategies to enhance compliance in this population by using determinants identified in exploratory studies.