Development of an integrated model of care for allogeneic stem cell transplantation facilitated by eHealth-the SMILe study.

PURPOSE: Allogeneic stem cell transplantation would benefit from re-engineering care towards an integrated eHealth-facilitated care model. With this paper we aim to: (1) describe the development of an integrated care model (ICM) in allogeneic SteM-cell-transplantatIon faciLitated by eHealth (SMILe) by combining implementation, behavioral, and computer science methods (e.g., contextual analysis, Behavior Change Wheel, and user-centered design combined with agile software development); and (2) describe that model's characteristics and its application in clinical practice. METHODS: The SMILe intervention's development consisted of four steps, with implementation science methods informing each: (1) planning its set-up within a theoretical foundation; (2) using behavioral science methods to develop the content; (3) choosing and developing its delivery method (human/technology) using behavioral and computer science methods; and (4) describing its characteristics and application in clinical practice. RESULTS: The SMILe intervention is embedded within the eHealth enhanced Chronic Care Model, entailing four self-management intervention modules, targeting monitoring and follow-up of important medical and symptom-related parameters, infection prevention, medication adherence, and physical activity. Interventions are delivered partly face-to-face by a care coordinator embedded within the transplant team, and partly via the SMILeApp that connects patients to the transplant team, who can monitor and rapidly respond to any relevant changes within 1 year post-transplant. CONCLUSION: This paper provides stepwise guidance on how implementation, behavioral, and computer science methods can be used to develop interventions aiming to improve care for stem cell transplant patients in real-world clinical settings. This new care model is currently being tested in a hybrid I effectiveness-implementation trial.

Depressive symptoms at 1 year after surgery increase the risk of cardiac allograft vasculopathy and mortality in heart transplant recipients: A prospective cohort study.

OBJECTIVE: To investigate the impact of depressive symptoms at 1-year post-heart transplant (HTx) on cardiac allograft vasculopathy (CAV) and mortality. METHODS: We performed a single-center prospective cohort study of patients 1-year post-HTx consecutively enrolled between January 2001 and September 2015, and followed-up until November 2020. Kaplan-Meier and uni- and multivariate cox proportional hazards models were used to investigate the impact of depressive symptoms (Beck Depression Inventory) on all-cause mortality and clustered CAV events, i.e. time to angiographically detected CAV, revascularizations, retransplantation/CAV-mortality. RESULTS: 23.7% (45/190) (median age 53.5 [IQR 19.3], 77% men) had mild to severe depressive symptoms (BDI 10-63). Forty-four patients (23.2%) died during a 10.4 years median follow-up. Depressive symptoms (BDI ≥ 10) increased all-cause mortality risk (HR = 2.52 [1.35-4.71], p = .004), even after adjusting for confounders (HR = 2.95 [1.50-5.80], p = .002). CAV data were available for 156 patients. During a 9.9 years median follow-up, 51 patients (32.7%) developed CAV or revascularization of which 8 received at least a second revascularization, 3 were re-transplanted, and 9 died from CAV-related causes. Analysis showed a significant increased CAV-risk among depressed patients (HR = 2.27 [1.10-4.69], p = .026), even in adjusted models (HR = 2.25 [1.01-4.98, p = .047). CONCLUSION: Depressive symptoms at 1-year post-HTx unfavorably impact mortality and CAV, highlighting the need for interventions.

How to screen for at-risk alcohol use in transplant patients? From instrument selection to implementation of the AUDIT-C.

BACKGROUND: Given that drinking >2-3 units of alcohol daily might already have adverse health effects, regular screening of at-risk drinking is warranted. We aimed to select and pilot a short instrument to accurately screen for at-risk drinking in transplant patients. METHODOLOGY AND RESULTS: Five consecutive steps were completed: A comprehensive literature review identified 24 possible self-report instruments (step 1). These instruments were scored on six yes/no criteria (ie, length, concept measured, diagnostic accuracy, population, manual available, cost) (step 2). Four nurses piloted three instruments with the highest score and were interviewed on their experiences with using the AUDIT-C, TWEAK, and Five Shot. The AUDIT-C was the easiest to use and score, and items were clear. Cognitive debriefings with 16 patients were conducted to verify clarity of instructions and items, and suggestions were incorporated into a modified version of the AUDIT-C (step 4). A convenience sample of 130 Dutch-speaking heart transplant patients completed the modified AUDIT-C during a scheduled visit (Step 5), revealing that 27.6% of patients showed at-risk drinking. CONCLUSION: The AUDIT-C might be a suitable instrument to identify at-risk drinking in routine post-transplant follow-up. Further validation, however, is indicated.

Correlates and outcomes of alcohol use after single solid organ transplantation: A systematic review and meta-analysis.

BACKGROUND: Reviews on alcohol use in transplant recipients focus on liver recipients and their risk of post-transplant rejection, but do not assess alcohol use in kidney, heart, or lung transplant recipients. This systematic review and meta-analysis aims to synthesize the evidence on correlates and outcomes of any alcohol use and at-risk drinking after solid organ transplantation (Tx). METHODS: We searched 4 databases for quantitative studies in adult heart, liver, kidney and lung Tx recipients, investigating associations between post-Tx alcohol use and correlates and/or clinical, economic or quality of life outcomes. Paper selection, data extraction and quality assessment were performed by 2 reviewers independently. A pooled odds ratio (OR) was computed for each correlate/outcome reported ≥5 times. RESULTS: Of the 5331 studies identified, 76 were included in this systematic review (93.3% on liver Tx; mean sample size 148.9 (SD = 160.2); 71.9% male; mean age 48.9 years (SD = 6.5); mean time post-Tx 57.7 months (SD = 23.1)). On average, 23.6% of patients studied used alcohol post-transplant. Ninety-three correlates of any post-Tx alcohol use were identified, and 9 of the 19 pooled ORs were significantly associated with a higher odds for any post-Tx alcohol use: male gender, being employed post-transplant, smoking pre-transplant, smoking post-transplant, a history of illicit drug use, having first-degree relatives who have alcohol-related problems, sobriety <6 months prior to transplant, a history of psychiatric illness, and having received treatment for alcohol-related problems pre-transplant. On average 15.1% of patients had at-risk drinking. A pooled OR was calculated for 6 of the 47 correlates of post-Tx at risk drinking investigated, of which pre-transplant smoking was the only correlate being significantly associated with this behavior. None of the outcomes investigated were significantly associated with any use or at-risk drinking. CONCLUSION: Correlates of alcohol use remain under-investigated in solid organ transplant recipients other than liver transplantation. Further research is needed to determine whether any alcohol use or at-risk drinking is associated with poorer post-transplant outcomes. Our meta-analysis highlights avenues for future research of higher methodological quality and improved clinical care. PROTOCOL REGISTRATION: PROSPERO protocol CRD42015003333.

The international prevalence and variability of nonadherence to the nonpharmacologic treatment regimen after heart transplantation: Findings from the cross-sectional BRIGHT study.

INTRODUCTION: Heart transplant (HTx) recipients need to follow a complex therapeutic regimen. We assessed the international prevalence and variability in nonadherence to six nonpharmacologic treatment components (physical activity, sun protection, diet, alcohol use, nonsmoking, and outpatient follow-up visits). METHODS: We used self-report data of 1397 adult HTx recipients from the 36-HTx-center, 11-country, 4-continent, cross-sectional BRIGHT study (ClinicalTrials.gov ID: NCT01608477). The nonadherence definitions used were as follows: Physical activity: <3 times/wk 20 minutes' vigorous activity, <5 times/wk 30 minutes' moderate activity, or <5 times/wk a combination of either intensity; Sun protection: not "always" applying any sun protection; Diet: not "often" or "always" following recommended diet(s); Alcohol use: >1 alcoholic drink/d (women) or >2 drinks/d (men); Smoking: current smokers or stopped <1 year before; Follow-up visits: missing ≥1 of the last 5 outpatient follow-up visits. Overall prevalence figures were adjusted to avoid over- or underrepresentation of countries. Between-country variability was assessed within each treatment component via chi-square testing. RESULTS: The adjusted study-wide nonadherence prevalence figures were as follows: 47.8% for physical activity (95% CI [45.2-50.5]), 39.9% for sun protection (95% CI [37.3-42.5]), 38.2% for diet recommendations (95% CI [35.1-41.3]), 22.9% for alcohol consumption (95% CI [20.8-25.1]), 7.4% for smoking cessation (95% CI [6.1-8.7]), and 5.7% for follow-up visits (95% CI [4.6-6.9]). Significant variability was observed between countries in all treatment components except follow-up visits. CONCLUSION: Nonadherence to the post-HTx nonpharmacologic treatment regimen is prevalent and shows significant variability internationally, suggesting a need for tailored adherence-enhancing interventions.

The ELPAT living organ donor Psychosocial Assessment Tool (EPAT): from 'what' to 'how' of psychosocial screening - a pilot study.

Thorough psychosocial screening of donor candidates is required in order to minimize potential negative consequences and to strive for optimal safety within living donation programmes. We aimed to develop an evidence-based tool to standardize the psychosocial screening process. Key concepts of psychosocial screening were used to structure our tool: motivation and decision-making, personal resources, psychopathology, social resources, ethical and legal factors and information and risk processing. We (i) discussed how each item per concept could be measured, (ii) reviewed and rated available validated tools, (iii) where necessary developed new items, (iv) assessed content validity and (v) pilot-tested the new items. The resulting ELPAT living organ donor Psychosocial Assessment Tool (EPAT) consists of a selection of validated questionnaires (28 items in total), a semi-structured interview (43 questions) and a Red Flag Checklist. We outline optimal procedures and conditions for implementing this tool. The EPAT and user manual are available from the authors. Use of this tool will standardize the psychosocial screening procedure ensuring that no psychosocial issues are overlooked and ensure that comparable selection criteria are used and facilitate generation of comparable psychosocial data on living donor candidates.

The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial.

In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30-60 mL/min/1.73 m2) were randomized to start everolimus with CNI withdrawal (N = 29) or continue their current CNI-based immunosuppression (N = 28). The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p = 0.18). In the on-treatment analysis, the difference did reach statistical significance (+9.4 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p = 0.047). The composite safety endpoint of all-cause mortality, major adverse cardiovascular events, or treated acute rejection was not different between groups. Nonfatal adverse events occurred in 96.6% of patients in the everolimus group and 57.1% in the CNI group (p < 0.001). Ten patients (34.5%) in the everolimus group discontinued the study drug during follow-up due to adverse events. The poor adherence to the everolimus therapy might have masked a potential benefit of CNI withdrawal on renal function.

Correlates and Outcomes of Posttransplant Smoking in Solid Organ Transplant Recipients: A Systematic Literature Review and Meta-Analysis.

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.

Toward a Conceptualization of the Content of Psychosocial Screening in Living Organ Donors: An Ethical Legal Psychological Aspects of Transplantation Consensus.

BACKGROUND: Across Europe, transplant centers vary in the content of the psychosocial evaluation for eligible living organ donors. To identify whether a common framework underlies this variation in this evaluation, we studied which psychosocial screening items are most commonly used and considered as most important in current psychosocial screening programs of living organ donors. METHODS: A multivariate analytic method, concept mapping, was used to generate a visual representation of the "psychosocial" screening items of living kidney and liver donors. A list of 75 potential screening items was derived from a systematic literature review and sorted and rated for their importance and commonness by multidisciplinary affiliated health care professionals from across Europe. Results were discussed and fine-tuned during a consensus meeting. RESULTS: The analyses resulted in a 6-cluster solution. The following clusters on psychosocial screening items were identified, listed from most to least important: (1) personal resources, (2) motivation and decision making, (3) psychopathology, (4) social resources, (5) ethical and legal factors, and (6) information and risk processing. CONCLUSIONS: We provided a conceptual framework of the essential elements in psychosocial evaluation of living donors which can serve as a uniform basis for the selection of relevant psychosocial evaluation tools, which can be further tested in prospective studies.

Predonation psychosocial evaluation of living kidney and liver donor candidates: a systematic literature review.

Evaluating a person's suitability for living organ donation is crucial, consisting not only of a medical but also of a thorough psychosocial screening. We performed a systematic literature review of guidelines, consensus statements, and protocols on the content and process of psychosocial screening of living kidney and liver donor candidates. We searched PubMed, Embase, CINAHL, and PsycINFO until June 22, 2011, following the PRISMA guidelines, complemented by scrutinizing guidelines databases and references of identified publications. Thirty-four publications were identified, including seven guidelines, six consensus statements, and 21 protocols or programs. Guidelines and consensus statements were inconsistent and lacked concreteness for both their content and process, possibly explaining the observed variability in center-specific evaluation protocols and programs. Overall, recommended screening criteria are not evidence-based and an operational definition of the concept "psychosocial" is missing, causing heterogeneity in terminology. Variation also exists on methods used to psychosocially evaluate potential donors. The scientific basis of predonation psychosocial evaluation needs to be strengthened. There is a need for high-quality prospective psychosocial outcome studies in living donors, a uniform terminology to label psychosocial screening criteria, and validated instruments to identify risk factors.

Academic Service Partnerships: what do we learn from around the globe? A systematic literature review.

BACKGROUND: Academic Service Partnerships (ASPs) are structural linkages between universities and service entities that aim to share vision and collaboration, thereby improving patient care quality and encouraging innovation. PURPOSE: To identify structured ASPs in nursing worldwide and to describe their characteristics. METHOD: Systematic literature review of PubMed-, CINAHL-, PsycINFO-, and Embase- listed studies published up to August 31, 2010. ASPs were described in view of a predefined set of criteria. RESULTS: A total of 114 articles describing 119 ASPs were included. Of these, 85% were located in North America. The median duration of ASPs was 6 years (interquartile range, 2-6). The majority focused on education (86%) and clinical practice (50%). Community health facilities (57%) and hospitals (40%) were prime settings. Twenty-two percent of ASPs were defined by contracts, 3% were governed by bylaws, and 66% were part of strategic plans (28%). Funding sources were mentioned in 76%. However, although 66% of ASPs have been evaluated, the evaluations are generally neither consistent nor reliable. CONCLUSIONS: ASPs show variability in setup, and their development seems to be fueled by policy reports.

Living organ donation practices in Europe - results from an online survey.

In Europe, living organ donation (LOD) is increasingly accepted as a valuable solution to overcome the organ shortage. However, considerable differences exist between European countries regarding frequency, practices and acceptance of donor-recipient relations. As a response, the Coordination Action project 'Living Organ Donation in Europe' (www.eulod.eu), funded by the Seventh Framework Programme of the European Commission, was initiated. Transplant professionals from 331 European kidney and liver transplant centres were invited to complete an online survey on living kidney donation (LKD) and living liver donation (LLD). In total, 113 kidney transplant centres from 40 countries and 39 liver transplant centres from 24 countries responded. 96.5% and 71.8% performed LKD and LLD respectively. The content of the medical screening of donors was similar, but criteria for donor acceptance varied. Few absolute contraindications for donation existed. The reimbursement policies diverged and the majority of the donors did not get reimbursed for their income loss during recovery. Large discrepancies were found between geographical European regions (the Eastern, the Mediterranean and the North-Western). As a result of this survey we suggest several recommendations to improve quality and safety of LOD in Europe.