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

Dobbels, Fabienne; Bleser, Leentje De; Berben, Lut; Kristanto, Paulus; Dupont, Lieven; Nevens, Frederik; Vanhaecke, Johan; Verleden, Geert M.; Geest, Sabina De

doi:10.1016/j.healun.2017.01.007

Cited by 100 publications

(118 citation statements)

References 40 publications

(61 reference statements)

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“…Also the condition of the study population in which the intervention was studied varied considerably (asthma, smoking cessation, renal, heart, liver and lung transplantation, hypertension, HIV, secondary hyperparathyroidism and patients at risk from cardiovascular conditions) [25–34]. However, the efficacy of EMF in HIV positive patients and smoking cessation was reported by two studies for both conditions [26;28;30;31].…”

Section: Resultsmentioning

confidence: 99%

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

et al. 2017

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ObjectiveThis study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients.MethodsA systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence.ResultsOf 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive.ConclusionConsidering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

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Section: Resultsmentioning

confidence: 99%

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

et al. 2017

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“…Since the beginning of our transplant program we have actively invested in these topics (23)(24)(25)(26)(27). This has not only resulted in scientific output, but has also likely lowered the threshold for patients to contact the transplant nurses and physicians in case of questions or problems.…”

Section: Discussionmentioning

confidence: 99%

“…Until the end of 2015, 648 transplantations were performed in 615 patients, resulting in an average annual transplantation rate of 23 (range, [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. Thirty recipients received a second donor heart and one patient was transplanted three times.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

How to obtain and maintain favorable results after heart transplantation: keys to success?

Cleemput

Verbelen²,

Aelst

et al. 2018

Ann. Cardiothorac. Surg.

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We compared survival in our heart recipients with survival rates reported by the International Society of Heart and Lung Transplantation (ISHLT) Registry. As recipient and donor characteristics are changing over time, we studied four different eras. In order to differentiate between short-and long-term survival, we analyzed both overall survival and survival at one year. Obviously, this exercise is only relevant when baseline donor and recipient characteristics are comparable, as these differences may affect the outcome in opposite directions. To overcome this potential bias as much as possible, we calculated the Index for Mortality Prediction After Cardiac Transplantation (IMPACT)-scores and the Donor Risk Index (DRI). Looking to our results, we found that our DRIs in the different eras are almost equal to those obtained from the United Network for Organ Sharing database in the very same eras. Our IMPACT-scores, on the other hand, seem higher than those reported by ISHLT. Survival after transplantation and conditional on 1-year survival was higher than the outcome reported by the ISHLT Registry. As our operation technique and post-transplant immunosuppressive schedule did not differ from most centers, we speculated on potential factors that might contribute to our positive results. Patient selection and a relatively short waiting time are important contributors to the overall survival benefit. Our centralized follow-up may also have played an important role. Finally, the indefinite compulsory health insurance coverage in our country and easy access to different screening programs might also have influenced our outcome in a positive way. We are well aware that with challenges like donor organ shortage, more and more patients on mechanical circulatory support (MCS) will affect outcomes in the future.Keywords: Heart transplantation; predictors; survival Submitted Sep 11, 2017. Accepted for publication Nov 25, 2017Nov 25, . doi: 10.21037/acs.2017 View this article at: http://dx.doi.org/10. 21037/acs.2017.12.03 Perspective IntroductionComparing the results of hip surgery performed by one surgeon with the results of his colleague working in the hospital next door, is asking for trouble. Comparing results of one heart transplant center with those of another or, even more challenging, those of a registry, is at least as daunting.Nevertheless, it is worthwhile to critically review one's results and compare them with those of peers. In case they differ manifestly, one has to speculate on why this is the case considering the importance our society currently attributes to cost effectiveness and transparency. Of course, this exercise only makes sense when you are comparing apples with apples. You should first examine that you are transplanting the same types of patients and that you are using the same types of donors.We compared our short-and long-term survival data with those of the ISHLT registry. To do so, we also compared our recipient and donor risk profiles with those of the UNOS database. Finally, we speculated...

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“…A memory chip embedded in bottle caps or blister packs tracks medication adherence electronically. The most extensively used product is the MEMS cap [17] (AARADEX Group, SA) which records the date and time of each opening. However, if a subject takes too many (or no) pills when the cap is opened, or removes pills and takes them later, a false record of dosing is created [12].…”

Section: Discussionmentioning

confidence: 99%

“…Electronic monitoring devices have been shown to provide good quality information on adherence rates [12] and hold promise for improving adherence, as demonstrated in multiple clinical trials [17,20,21]. Methods which involve reinforcement interventions were successful in improving patient's cooperation and adherence behaviors.…”

Section: Discussionmentioning

confidence: 99%

Use of a Digital Medication Management System for Effective Assessment and Enhancement of Patient Adherence to Therapy (ReX): Feasibility Study (Preprint)

Shtrichman¹,

Conrad²,

Schimo³

et al. 2018

Preprint

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Abstract:Background: Medication non-adherence is a major problem in healthcare, imposing poor clinical outcomes and a heavy financial burden on all stakeholders. Current methods of adherence assessment are severely limited: they are applied only periodically, do not relate to actual pill intake and suffer from patient bias due to errors, misunderstanding or intentional non-adherence. ReX is an innovative drug management system designed to address poor patient adherence and enhance patient engagement with their therapy. ReX controls and tracks pills from the point of packaging right through to the patient's mouth. ReX generates robust, real-time adherence data. Interactive communication with the system enables patients to report outcomes, complete surveys and receive messages and instructions. ReX includes a reusable Drug Dispensing Unit, disposable Cassette containing pills and a cloud-based, data portal.Objectives: The objectives of this study were to evaluate: 1) ReX safety 2) acceptance and usability of ReX innovative technology 3) efficacy of ReX in (a) providing pills according to the dose regimen; (b) managing reminders and adherence data; (c) enhancing adherence rates compared to standard of care.Methods: ReX system components and operation are demonstrated. The ReX system safety, usability and efficacy were evaluated in two human-factor, non-clinical, feasibility studies. Human subjects used ReX for administration of pill-shaped Tic Tac sweets, according to a pre-programmed dose regimen. The first study, comprising 59 subjects aged 18-92 evaluated ReX use and administration of 2 pill intakes. The second study was a self-controlled, "walk around" study, comprising 40 subjects, aged 18-90. Subjects took pills at home, for 4 days each via the device (ReX test) or from standard packaging (Control test).Results: The first study confirmed the usability and acceptance of the ReX novel approach to pill dispensing. All subjects (100%) successfully managed 2 pill intakes. 81% of subjects rated the ReX device as easy to use. The second "walk around" study confirmed the safety, usability and efficacy of the ReX system. Overall adherence rate in the ReX test was 21% higher than in the Control test (P<0.0001, Confidence=95%). Real-time, personalized reminders, provided in the event of delay in pill intake, contributed to 18% of doses taken during the ReX test (P<0.0001, Confidence=95%). 87% of subjects found the ReX system easy to use and felt comfortable using it for their medications.Conclusions: ReX's novel "Tracking to the Mouth" technology was found to be safe, feasible and effective for oral medication therapy.

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

Abstract: Our intervention was efficacious in improving adherence and sustainable. Further research should investigate clinical impact, cost-effectiveness, and scalability.

Cited by 100 publications

References 40 publications

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

How to obtain and maintain favorable results after heart transplantation: keys to success?

Use of a Digital Medication Management System for Effective Assessment and Enhancement of Patient Adherence to Therapy (ReX): Feasibility Study (Preprint)

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