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Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform
Published on: April 12, 2021
Medication adherence interventions in transplantation lack information on how to implement findings from randomized
Barbora Kostalova1, Janette Ribaut2, Fabienne Dobbels3
1Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University, Akademika Heyrovskeho 1203, 500 05 Hradec Kralove, Czech Republic.
Background:
Growing numbers of randomized controlled trials (RCTs) are showing the effectiveness of interventions to improve medication adherence in transplantation recipients. However, real-world implementation is still a major challenge. This systematic review assesses the range of information available in RCTs supporting these interventions' clinical adoption in adult transplant populations.
Methods:
We included RCTs of interventions that a) targeted any phase of medication adherence in solid organ or allogeneic stem cell transplantation recipients and b) were published between January 2015 and November 2020. We excluded study protocols, conference abstracts and studies focusing only on pediatric populations. We identified relevant database and trial registries as well as traced references backward and citations forward. Implementation-relevant information was evaluated using adapted versions of Peters' ten criteria: 1. healthcare/organizational context; 2. social/economic/policy context; 3. patient involvement; 4. other stakeholder involvement; 5. sample representativeness; 6. trial conducted in a real-world-setting; 7. presence of feasibility study; 8. implementation strategy; 9. process evaluation; 10. implementation outcomes, using a stoplight color-rating system.
Results:
Screening 17'004 titles/abstracts resulted in 23 eligible RCTs, including 2'339 patients (n = 19-209/study). All included studies focused on the implementation phase of medication adherence. The best-reported criteria were feasibility study (43%), representative sample (17%) and conducted in a real-world-setting (17%). Least reported were context (9%), implementation strategies (4%), process evaluation (4%).
Conclusions:
RCTs testing medication adherence interventions tend to report limited implementation-relevant information. This hinders their translation to real-world transplant settings. Integrating implementation science principles early in the conceptualization of RCTs would fuel real-world-translation, reducing research waste.
Insights
Randomized controlled trials (RCTs) show promise for improving medication adherence in transplant patients. However, limited implementation data in RCTs hinders real-world use, suggesting a need for early integration of implementation science.
Area of Science:
- Transplantation Medicine
- Implementation Science
- Clinical Trial Design
Background:
- Randomized controlled trials (RCTs) increasingly demonstrate interventions to improve medication adherence in transplant recipients.
- Translating these interventions into real-world clinical practice remains a significant challenge.
- This systematic review evaluates the implementation-relevant information within RCTs for adult transplant populations.
Purpose of the Study:
- To assess the extent of implementation-relevant information provided in RCTs for medication adherence interventions in adult transplant recipients.
- To identify gaps in reporting that may impede clinical adoption and real-world translation.
Main Methods:
- Systematic review of RCTs published between January 2015 and November 2020.
- Included studies focused on medication adherence in solid organ or allogeneic stem cell transplant recipients.
- Evaluated 10 implementation criteria adapted from Peters' criteria using a stoplight rating system.
Main Results:
- 23 RCTs involving 2,339 patients were included, all focusing on the implementation phase of medication adherence.
- Feasibility studies (43%), representative samples (17%), and real-world settings (17%) were the best-reported criteria.
- Contextual information (9%), implementation strategies (4%), and process evaluations (4%) were least reported.
Conclusions:
- RCTs on medication adherence interventions in transplantation often lack crucial implementation details.
- This deficit hinders the successful translation of research findings into clinical practice.
- Early integration of implementation science principles into RCT design is essential to improve real-world applicability and reduce research waste.
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