Leentje De Bleser

Interventions to improve medication-adherence after transplantation: a systematic review

Reports of interventions to improve adherence to medical regimens in solid organ transplant recipients are scarce. A systematic review identified 12 intervention studies. These studies focused on renal, heart, and liver transplant recipients. Five reports used randomized controlled trial (RCT) designs. Sample sizes varied between 18 and 110 subjects. The interventions are difficult to evaluate and categorize because of brief descriptions of intervention details. Of the 12 studies identified in this review, only five studies found a statistically significant improvement in at least one medication‐adherence outcome with the intervention. In general, most included a combination of patient‐focused cognitive/educational, counseling/behavioral, and psychologic/affective dimensions. Eight studies intervened at the healthcare provider, healthcare setting or healthcare system level, but showed a limited improvement in adherence. No single intervention proved to be superior at increasing medication‐adherence in organ transplantation, but a combination of interventions in a team approach for the chronic disease management of organ transplant patients may be effective in a long‐term perspective. In conclusion, finding the most effective combination of interventions to enhance adherence is vital. Utilizing an RCT design and adhering to the CONSORT guidelines can lead to higher quality studies and possibly more effective intervention studies to enhance medication‐adherence.

Quality of life and health status in adults with congenital heart disease: a direct comparison with healthy counterparts.

Introduction Despite having increased life expectancy, patients with congenital heart disease are sometimes presumed to have a diminished quality of life. This study therefore assessed the quality of life and perceived health of adults with congenital heart disease and compared these two measures with those reported by healthy control subjects. Methods Using a comparative study design, we examined quality of life and perceived health in 404 patients who were matched for age, sex, educational level, and employment status with 404 healthy counterparts. Quality of life was measured using a linear analog scale and the Satisfaction with Life Scale. Problems and concerns relevant to patients’ quality of life were assessed by the Congenital Heart Disease-TNO-AZL Adult Quality of Life scale. Perceived health was also assessed with a linear analog scale. Results Patients perceived their quality of life (median linear analog scale score 80; median Satisfaction with Life Scale score 28) and health status to be good (median linear analog scale 80). Quality of life was significantly better in patients with congenital heart disease than in healthy peers, with a mean standardized difference of 0.22 on the linear analog scale and 0.34 on the Satisfaction with Life Scale. No group difference was found for perceived health. Problems and concerns in adults with congenital heart disease overlapped to a large extent with those identified by control subjects. Patients reported significantly higher distress scores for 16 of 77 items, whereas control subjects perceived more distress for 20 items. Conclusion Adults with congenital heart disease perceived their quality of life to be better than did their healthy counterparts. This finding refutes the presumed lower quality of life in patients with cardiac anomalies. Eur J Cardiovasc Prev Rehabil 13:407-413

The spectrum of nonadherence with medication in heart, liver, and lung tranplant patients assessed in various ways

Adherence to medication regimes is crucial for transplant patients. Addressing methodological limitations and gaps in the literature, we studied: (i) the prevalence of nonadherence (NA) with immunosuppression (IS) using various measurement methods, (ii) NA prevalence regarding intake and timing, (iii) changes in NA over time, (iv) differences in NA across organ transplant populations, (v) NA regarding co‐medication. Using a descriptive, prospective, comparative design over 3 months, we included convenience samples of adult heart (n = 79), liver (n = 55), and lung (n = 104) transplant patients. NA with IS was measured using self‐report, collateral report, blood assay, electronic monitoring (Helping HandTM, Bang and Olufsen Medicom, Denmark), and their combinations. In the overall sample, depending on the method used, IS NA ranged from 23.9% to 70.0%. For co‐medication, the overall NA rate was 30.1% using self‐report. Nonadherence rates remained stable over time. At inclusion, significant NA differences between organ groups were reported via self‐ and collateral report; lung transplant patients were less adherent than heart or liver transplant recipients, both to IS and to co‐medication.

Profile of adults with congenital heart disease having a good, moderate, or poor quality of life: a cluster analytic study.

Aims: The purpose of the study was to assess the profile of adult patients with congenital heart disease who reported a good, moderate, or poor quality of life. Methods: We conducted a secondary analysis of data from a large-scale quality-of-life study that included 627 patients. Demographic and clinical variables were retrieved from the medical records and functional status from patient interviews. Overall quality of life was measured using a Linear Analogue Scale. Using K-means cluster analysis, we categorized subjects into a 3-cluster solution: good, moderate, or poor quality of life. Results: Four hundred ninety patients (78.1%) clustered into the good quality-of-life category; 126 patients (20.1%) clustered into the moderate quality-of-life category; and 11 patients (1.8%) clustered into the poor quality-of-life category. Poorer quality of life was associated with lower educational level, unemployment or disability, associated syndromes, instability of the heart disease, and a poorer functional status. Conclusion: Over three-quarters of the patients had a good quality of life, whereas only a small proportion had a poor quality of life. Specific demographic and clinical characteristics associated with a poor quality of life could assists in identifying patients at risk for developing a poor quality of life.

Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial

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.

A New Electronic Monitoring Device to Measure Medication Adherence: Usability of the Helping Hand™

The aim of this study was to test the user performance, satisfaction and acceptability of the Helping Hand™ (B&O Medicom) electronic medication adherence monitor. Using a mixed-method design, we studied 11 kidney transplant patients and 10 healthy volunteers during three weeks. Although testing showed positive usability aspects, several areas requiring technical improvement were identified: the most important obstacles to usability and acceptability were the weak sound signal, problems loading the medication, and the fact that only one medication could be used at a time.

How Accurate Are Electronic Monitoring Devices? A Laboratory Study Testing Two Devices to Measure Medication Adherence

In a prospective descriptive laboratory study, 25 Helping Hand™ (HH) (10 without and 15 with reminder system) and 50 Medication Event Monitoring Systems (MEMS) (25 with 18-month and 25 with 2-year battery life) were manipulated twice daily following a predefined protocol during 3 consecutive weeks. Accuracy was determined using the fixed manipulation scheme as the reference. Perfect functioning (i.e., total absence of missing registrations and/or overregistrations) was observed in 70% of the HH without, 87% of the HH with reminder, 20% MEMS with 18 months, and 100% with 2-year battery life respectively.

1423 Sexual Functioning in Adults with Congenital Heart Disease

1423 Sexual functioning in adults with congenital heart disease Philip Moons, Kristien Van Deyk, Kristel Marquet, Leentje De Bleser, Werner Budts, Sabina De Geest Centre for Health Services and Nursing Research, Katholieke Universiteit Leuven, Belgium; Division of Congenital Cardiology, University Hospitals of Leuven, Belgium; Institute of Nursing Science, University of Basel, Switzerland Corresponding author. Philip Moons, Centre for Health Services and Nursing Research, Katholieke Universiteit Leuven, Kapucijnenvoer 35/4, 3000 Leuven, Belgium. Email: Philip.Moons@med.kuleuven.ac.be