Telemedically Supported Case Management of Living-Donor Renal Transplant Recipients to Optimize Routine Evidence-Based Aftercare: A Single-Center Randomized Controlled Trial.

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.

Nurses' practice patterns in relation to adherence-enhancing interventions in stem cell transplant care: a survey from the Nurses Group of the European Group for Blood and Marrow Transplantation.

Recipients of stem cell transplants (SCT) must accurately manage multiple medications as non-adherence jeopardises treatment benefits. There is an evidence base for the efficacy of adherence-enhancing interventions; however, level of clinical implementation is unknown. This study aimed to identify patterns of practice in assessing medication adherence, screening for risk factors of non-adherence, interventions used in SCT to improve adherence and how nurses perceive the effectiveness of such interventions. A convenience sample of 143 European nurses completed a 29-item questionnaire measuring the frequency and perceived effectiveness of assessment/screening methods for adherence and three types of intervention (educational/cognitive, counselling/behavioural and psychological/affective). Questioning patients about adherence was the most regularly used assessment method (51.5%). Nurses used a median of seven interventions (interquartile range: six) 'frequently', the most popular being provision of reading materials (79%). The interventions perceived as most effective were; providing individual patient/family with teaching and reading materials. This is the first study exploring patterns of practice relating to adherence in SCT. Educational interventions were the most frequently employed style of intervention, which is at odds with recent data suggesting limited efficacy with this style of intervention. Combining educational, behavioural and psychological interventions would more accurately embrace current understanding.

Alcohol drinking after liver transplantation is associated with graft injury.

AIM: This was a single-center, mixed-design, cross-sectional and retrospective study to assess the performance of the 4-item, self-reported CAGE (Cut down, Annoyed, Guilty, Eye-opener) questionnaire in predicting histology-proven alcohol-related liver graft injury (ARLGI). METHODS: A total of 316 liver transplant (LT) patients between six months and five years were enrolled. Based on previous research, problem alcohol drinking (PAD) was defined as any score ≥ 1 on the CAGE, while a cut-off of 2 was assumed for alcohol dependence (AD). RESULTS: Responders were 195, 45 (23.1%) had a CAGE score ≥ 1 and 30 (15.3%) scored ≥ 2. After controlling for confounders, PAD was associated with hyperlipidemia (P=0.01), while AD with a male gender (P=0.01), hyperlipidemia (P=0.03) and alcohol as native diagnosis (P=0.03). PAD and AD were both associated with a significantly higher prevalence of ARLGI, i.e. 53.3% and 63.3%, respectively (P<0.0001). Hepatitis C virus (HCV) patients with PAD showed more steatosis (P=0.04), portal infiltrate (P=0.03), and pericellular/perivenular fibrosis (P=0.02). The likelihood ratios for CAGE scores ranging from 0 to 4 in predicting ARLGI were 0, 5.2, 7.8, 7.8, and 100, respectively. CONCLUSION: By use of a self-report instrument we found a 23.1% prevalence of PAD and a 15.3% prevalence of AD among LT patients between six months and five years. A variable degree of ARLGI was present in 53.3% of PAD and 63.3% of AD, respectively. HCV patients with PAD had more steatosis, portal inflammation, and pericellular fibrosis. Transplant physicians might improve their ability to predict the probability for ARLGI using the CAGE.

Adherence to the immunosuppressive regimen in pediatric kidney transplant recipients: a systematic review.

As most prior reviews on NA focus on adult transplant patients, there is a need for a comprehensive overview on adherence to the immunosuppressive regimen in pediatric kidney transplant patients. This systematic review searched for English-language papers (1990-2008) addressing the prevalence of NA to the immunosuppressive regimen, its consequences, determinants, and interventions in pediatric kidney transplant patients (< age 21 yr). We found 36 papers, showing a prevalence of NA (weighted mean) of 31.8% with adolescents being more at risk compared to younger patients. About 44% of all graft losses and 23% of late acute rejection episodes are associated with NA. Most studies investigated socio-economic, condition-related or treatment-related determinants. Only one educational intervention has been tested but yielded inconclusive results. NA to the immunosuppressive regimen is prevalent with serious clinical consequences in pediatric kidney transplant patients, but the economic consequences have not yet been explored. More studies on determinants of NA are needed. The literature currently lacks fully powered RCTs testing adherence-enhancing interventions. The results of this systematic review identify the gaps in the present evidence-based information regarding NA and can be used as a tool to pursue future adherence research in pediatric populations.

Nonadherence consensus conference summary report.

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.

Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients.

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.

Symptom experience associated with immunosuppressive drugs after liver transplantation in adults: possible relationship with medication non-compliance?

Symptom experience (occurrence and perceived distress) associated with side effects of immunosuppressive medications in organ transplant patients may well be associated with poorer quality of life and medication non-compliance. The aims of this study were: first, to assess symptom experience in clinically stable adult patients during long-term follow-up after liver transplantation; and second, to study the relationship between symptom experience and medication non-compliance. This cross-sectional study included 123 liver transplant patients. Symptom experience was assessed using the "Modified Transplant Symptom Occurrence and Symptom Distress Scale" (29-item version) at the annual evaluation. According to the duration of follow-up, patients were divided into a short-term (1-4 yr) and a long-term (5-18 yr) cohort. Medication non-compliance was measured using electronic monitoring. Results showed that increased hair growth was the most frequent symptom in both sexes. Symptom distress was more serious in women than in men. The most distressing symptom in women was excessive and/or painful periods, while in men this was impotence. Clear differences were revealed at item level between symptom occurrence and symptom distress in relationship with the two time cohorts and between sexes. No relationship was found between symptom experience and prednisolone non-compliance.

Achieving blood pressure goals globally: five core actions for health-care professionals. A worldwide call to action.

The prevalence of hypertension continues to rise across the world, and most patients who receive medical intervention are not adequately treated to goal. A Working Group including representatives of nine international health-care organizations was convened to review the barriers to more effective blood pressure control and propose actions to address them. The group concluded that tackling the global challenge of hypertension will require partnerships among multiple constituencies, including patients, health-care professionals, industry, media, health-care educators, health planners and governments. Additionally, health-care professionals will need to act locally with renewed impetus to improve blood pressure goal rates. The Working Group identified five core actions, which should be rigorously implemented by practitioners and targeted by health systems throughout the world: (1) detect and prevent high blood pressure; (2) assess total cardiovascular risk; (3) form an active partnership with the patient; (4) treat hypertension to goal and (5) create a supportive environment. These actions should be pursued with vigour in accordance with current clinical guidelines, with the details of implementation adapted to the economic and cultural setting.

ESPACOMP Medication Adherence Reporting Guidelines (EMERGE): a reactive-Delphi study protocol.

INTRODUCTION: Medication adherence is fundamental to achieving optimal patient outcomes. Reporting research on medication adherence suffers from some issues-including conceptualisation, measurement and data analysis-that thwart its advancement. Using the ABC taxonomy for medication adherence as the conceptual basis, a steering committee of members of the European Society for Patient Adherence, COMpliance, and Persistence (ESPACOMP) launched an initiative to develop ESPACOMP Medication Adherence Reporting Guidelines (EMERGE). This paper is a protocol for a Delphi study that aims to build consensus among a group of topic experts regarding an item list that will support developing EMERGE. METHODS AND ANALYSIS: This study uses a reactive-Delphi design where a group of topic experts will be asked to rate the relevance and clarity of an initial list of items, in addition to suggesting further items and/or modifications of the initial items. The initial item list, generated by the EMERGE steering committee through a structured process, consists of 26 items distributed in 2 sections: 4 items representing the taxonomy-based minimum reporting criteria, and 22 items organised according to the common reporting sections. A purposive sample of experts will be selected from relevant disciplines and diverse geographical locations. Consensus will be achieved through predefined decision rules to keep, delete or modify the items. An iterative process of online survey rounds will be carried out until consensus is reached. ETHICS AND DISSEMINATION: An ethics approval was not required for the study according to the Swiss federal act on research involving human beings. The participating experts will be asked to give an informed consent. The results of this Delphi study will feed into EMERGE, which will be disseminated through peer-reviewed publications and presentations at conferences. Additionally, the steering committee will encourage their endorsement by registering the guidelines at the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network and other relevant organisations.

Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients.

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.

Hospital costs of protective isolation procedures in heart transplant recipients.

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.

Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients.

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.

A nurse-led interdisciplinary intervention program for delirium in elderly hip-fracture patients.

OBJECTIVES: To develop and test the effect of a nurse-led interdisciplinary intervention program for delirium on the incidence and course (severity and duration) of delirium, cognitive functioning, functional rehabilitation, mortality, and length of stay in older hip-fracture patients. DESIGN: Longitudinal prospective before/after design (sequential design). SETTING: The emergency room and two traumatological units of an academic medical center located in an urban area in Belgium. PARTICIPANTS: 60 patients in an intervention cohort (81.7% females, median age = 82, interquartile range (IQR) = 13) and another 60 patients in a usual care/nonintervention cohort (80% females, median age = 80, IQR = 12). INTERVENTION: (1) Education of nursing staff, (2) systematic cognitive screening, (3) consultative services by a delirium resource nurse, a geriatric nurse specialist, or a psychogeriatrician, and (4) use of a scheduled pain protocol. MEASUREMENTS: All patients were monitored for signs of delirium, as measured by the Confusion Assessment Method (CAM). Severity of delirium was assessed using a variant of the CAM. Cognitive and functional status were measured by the Mini-Mental State Examination (MMSE) (including subscales of memory, linguistic ability, concentration, and psychomotor executive skills) and the Katz Index of activities of daily living (ADLs), respectively. RESULTS: Although there was no significant effect on the incidence of delirium (23.3% in the control vs 20.0% in the intervention cohort; P =.82), duration of delirium was shorter (P =.03) and severity of delirium was less (P =.0049) in the intervention cohort. Further, clinically higher cognitive functioning was observed for the delirious patients in the intervention cohort compared with the nonintervention cohort. Additionally, a trend toward decreased length of stay postoperatively was noted for the delirious patients in the intervention cohort. Despite these positive intervention effects, no effect on ADL rehabilitation was found. Results for risk of mortality were inconclusive. CONCLUSIONS: This study demonstrated the beneficial effects of an intervention program focusing on early recognition and treatment of delirium in older hip-fracture patients and confirms the reversibility of the syndrome in view of the delirium's duration and severity.

Meeting the challenges for gerontological nursing in Europe: The European Nursing Academy for Care of Older persons (ENACO).

In order to support the urgent need for proactive and targeted investments in care for older persons a group of geriatric nurse specialists from different European countries convened in Leuven (Belgium) in November 2002 to launch the European Nursing Academy for Care of Older persons (ENACO). The mission of ENACO is to enhance outcomes of older persons and their caregivers through strengthening gerontological clinical nursing care, education, research and health policy within an interdisciplinary context. Specific objectives of ENACO are: 1) providing up-to-date education and training by "teaching the teachers". More specifically, the target groups are master's prepared nurses specialized in gerontology who can contribute and guide the development of gerontological/geriatric nursing care in their own country; 2) developing a core curriculum for basic gerontological nursing education in Europe and; 3) developing an European network of gerontological nursing expertise. More specifically, a web page providing opportunities for interactive communication as well as a mentoring program will be developed for nurses interested in the deepening and fine-tuning of their professional experience in care for older persons. The fact that care for older persons is high on the European agenda, the collaboration with the European Academy for Medicine of Ageing (EAMA), and other professional organizations in Europe and other parts of the world, are promising elements in the development of ENACO.

Symptom experience associated with maintenance immunosuppression after heart transplantation: patients' appraisal of side effects.

OBJECTIVE: To evaluate symptom experience related to side effects of immunosuppressive therapy in heart transplant recipients. METHODS: This descriptive, cross-sectional study included 105 heart transplant recipients (90 men; 15 women) with a median age of 56 years. Maintenance immunosuppression consisted of triple therapy (cyclosporine, corticosteroids, azathioprine). Symptom frequency and symptom distress were assessed by an adapted version of the Transplant Symptom Frequency and Symptom Distress Scale, which includes 27 symptoms associated with side effects of immunosuppressive therapy. RESULTS: The most frequent symptom for both sexes was increased hair growth. Impotence and painful menstruation were experienced as the most distressing symptoms for men and women, respectively. Women reported a significantly higher level of symptom experience. The majority of the most frequent and most distressing symptoms were corticosteroid associated. CONCLUSIONS: Patients' perception of side effects completes the symptomatologic profile of immunosuppressive therapy. A gender-specific evaluation is indicated because symptom experience differs between the sexes.

Clinical risk associated with appointment noncompliance in heart transplant recipients.

This study examined the prevalence of appointment noncompliance in 101 heart transplant recipients and how appointment noncompliance is related to patient profile and clinical risk. Appointment noncompliance was defined as patients not showing up at 1 or more planned clinic appointments (at a minimal frequency of every 3 months) during the previous year. Clinical variables were collected from medical files. Psychosocial variables were measured using established instruments. Medication noncompliance was assessed using electronic event monitoring. Paired t test, Wilcoxon 2-sample test, chi-square test, or Fisher exact test were used for statistical analysis as appropriate. The prevalence of appointment noncompliance was 7%. Appointment noncompliers were significantly younger, were less likely to live in a stable relationship with a partner, were more depressed, perceived their health as poorer, experienced more symptom distress, and had significantly more drug holidays. Fifty-seven percent of the appointment noncompliers experienced 1 or more late acute rejection episodes, compared to 2% of the appointment compliers. Appointment noncompliance is a critical behavioral risk factor in the occurrence of late acute rejection episodes in heart transplant patients. Patient profiles allow the identification of patients at risk for appointment noncompliance.

Psychosocial and behavioral selection criteria for solid organ transplantation.

An evidence-based selection process for organ transplantation may be a valuable approach to improve posttransplant outcomes. This paper reviews state-of-the-art psychosocial and behavioral selection criteria and assesses their validity in view of predicting outcomes after transplantation. Psychosocial factors addressed are psychiatric disorders, mental retardation, irreversible cognitive dysfunction, and lack of social support. Behavioral selection criteria discussed are alcoholism, smoking, drug abuse, and obesity. This review reveals that the evidence concerning these selection criteria in scarce. There is a definite need for more longitudinal research to strengthen the scientific basis of the psychosocial and behavioral dimension of transplantation.

Conditions, interventions, and outcomes in nursing research: a comparative analysis of North American and European/International journals. (1981-1990).

This study compared the conceptual foci and methodological characteristics of research projects which tested the effects of nursing interventions, published in four general nursing research journals with predominantly North American, and two with predominantly European/International authorship and readership. Dimensions and variables of comparison included: nature of subjects, design issues, statistical methodology, statistical power, and types of interventions and outcomes. Although some differences emerged, the most striking and consistent finding was that there were no statistically significant differences (and thus similarities) in the content foci and methodological parameters of the intervention studies published in both groups of journals. We conclude that European/International and North American nursing intervention studies, as reported in major general nursing research journals, are highly similar in the parameters studied, yet in need of overall improvement. Certainly, there is no empirical support for the common (explicit or implicit) ethnocentric American bias that leadership in nursing intervention research resides with and in the United States of America.