Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University, Akademika Heyrovskeho 1203, 500 05 Hradec Kralove, Czech Republic.
Institute of Nursing Science, Department of Public Health, University of Basel, Bernoullistrasse 28, 4056 Basel, Switzerland; Department of Theragnostic, Hematology, University Hospital of Basel, Petersgraben 4, 4031 Basel, Switzerland.
Transplant Rev (Orlando). 2022 Jan;36(1):100671. doi: 10.1016/j.trre.2021.100671. Epub 2021 Nov 2.
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.
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.
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%).
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.
越来越多的随机对照试验（RCT）表明，干预措施可以提高移植受者的药物依从性。然而，实际实施仍然是一个主要挑战。本系统评价评估了 RCT 中支持这些干预措施在成人移植人群中临床应用的信息范围。
我们纳入了针对以下情况的 RCT：a）靶向实体器官或异基因干细胞移植受者药物依从性任何阶段的干预措施；b）发表于 2015 年 1 月至 2020 年 11 月之间。我们排除了研究方案、会议摘要和仅关注儿科人群的研究。我们确定了相关数据库和试验注册处，并追溯了参考文献和引用文献。使用彼得斯十项标准的改编版本评估了实施相关信息：1. 医疗保健/组织背景；2. 社会/经济/政策背景；3. 患者参与；4. 其他利益相关者参与；5. 样本代表性；6. 在真实环境中进行的试验；7. 可行性研究的存在；8. 实施策略；9. 过程评估；10. 实施结果，使用信号灯颜色评级系统。
筛选了 17004 篇标题/摘要，最终纳入了 23 项合格的 RCT，包括 2339 名患者（n=19-209/研究）。所有纳入的研究都集中在药物依从性的实施阶段。报告最好的标准是可行性研究（43%）、代表性样本（17%）和在真实环境中进行的试验（17%）。报告最少的是背景（9%）、实施策略（4%）、过程评估（4%）。
测试药物依从性干预措施的 RCT 往往报告有限的实施相关信息。这阻碍了它们在真实世界移植环境中的转化。在 RCT 的概念化早期整合实施科学原则将推动真实世界的转化，减少研究浪费。
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