Hans Vlaminck

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.

Prospective Study on Late Consequences of Subclinical Non-Compliance with Immunosuppressive Therapy in Renal Transplant Patients

In this prospective study we compared the incidence of late acute rejections (LAR) and changes in serum‐creatinine over time between compliers and noncompliers with immunosuppressive therapy more than 1 year post transplantation and explored the relative contribution of non‐compliance and other risk factors in the occurrence of LAR.

Psychometric properties of the "Modified Transplant Symptom Occurrence and Symptom Distress Scale"

The aim of this study was to assess key aspects of the reliability and validity of the “Modified Transplant Symptom Occurrence and Distress Scale,” an instrument measuring symptom experience associated with side effects of triple drug therapy in transplant patients. This cross-sectional, comparative study included 108 renal transplant recipients (61% men; 39% women) with a median age of 47 years and a median posttransplant status of 5.5 years. Renal transplant patients were matched by age and gender with 108 healthy control persons not taking immunosuppressive drugs. Content validity, construct validity and discriminant validity of the instrument were substantiated. Internal consistency reliability was not useful to assess in this instrument, as the conditions for calculating Cronbach’s alpha were not satisfied. These findings document the validity of the “Modified Transplant Symptom Occurrence and Symptom Distress Scale” as an instrument to measure symptom experience with immunosuppressive drugs.

Acute rejection in non‐compliant renal allograft recipients: a distinct morphology

Abstract:  Non‐compliance for immunosuppressive medication is frequent in renal transplant recipients, and associated with late acute rejection and graft loss. Although numerous studies were published on risk factors and outcome, no data are available on the histopathology of the ‘non‐compliant’ allograft. As non‐compliant patients swing between subtherapeutic and toxic doses of immunosuppression, trough levels show large variation. We questioned whether the histology of acute rejection in non‐compliers (i) differs from the ‘classical’ acute rejection; (ii) shows more concomitant calcineurin‐inhibitor toxicity; (iii) is associated with C4d and plasma cell (PC)‐rich infiltrates. Based on validated interview methods/self reporting, 145 adult renal allograft recipients, transplanted for greater than one yr, on cyclosporine A and corticosteroids, were categorized as either compliant or non‐compliant. Non‐compliance was defined in 32 patients (22.1%). All late (greater than one yr) allograft biopsies were reviewed (Banff) and immuno‐stained for C4d. Computerized morphometry was performed on late biopsies with features of acute cellular rejection. Sixty‐two patients had ≥1 late biopsy [41 (36.2%) compliant/21 (65.6%) non‐compliant; p = 0.0043], comprising a pool of 90 biopsies (61 compliant/29 non‐compliant; p = 0.0303). ‘Non‐compliant’ biopsies had higher scores of C4d (p = 0.0092), acute tubular damage (p = 0.0058), and peritubular capillaritis (p = 0.0070). ‘Non‐compliant’ biopsies with acute cellular rejection showed less interstitial edema (p = 0.0165), more interstitial infiltrate (p = 0.0100), more interstitial fibrosis (p = 0.0277), and more tubular atrophy (p = 0.0197). PC‐rich infiltrates correlated with C4d (p = 0.0080). Detection of non‐compliance is mandatory as it represents an important cause of graft loss. This study describes histologic features of renal allograft biopsies in non‐compliant patients that could help identifying this patient profile.

EUROPEAN PRACTICE IN HAEMODIALYSLYSLYSIS: RERESULTS OF THE EPD

SUMMARY The European Practice Database (EPD) project, developed by the EDTNA/ERCA Research Board, collects data on renal practice at centre level in different European countries. Results presented in this paper focus on the European Practice in Haemodialysis centres from 8 European countries or regions following data collection from 2002 to 2004. These results will enable international comparison in practice and will stimulate further research and the development of new practice recommendations.