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首页> 外文期刊>Clinical transplantation. >Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens.
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Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens.

机译:在肾移植(SMART)中支持药物依从性:一项试验性RCT,可提高对免疫抑制方案的依从性。

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BACKGROUND: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational-behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time. METHODS: Eighteen RTx non-adherent patients (age: 45.6 +/- 1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n = 6) or an enhanced usual care group (EUCG) (n = 12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up). RESULTS: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(2) = 3.40, df = 1, p = 0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, chi(2) = 1.05, df = 1, p = 0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months). CONCLUSION: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.
机译:背景:尽管不遵守免疫抑制方案(NAH)是肾移植(RTx)后不良结局的主要危险因素,但很少有研究在这种情况下检查不遵守干预措施。这项试验性随机对照试验(RCT)测试了教育行为干预在增加非依从性RTx患者依从性方面的功效。我们还评估了NAH如何随着时间演变。方法:将18例RTx非依从性患者(年龄:45.6 +/- 1.2岁;男性78.6%)随机分为干预组(IG)(n = 6)或加强常规护理组(EUCG)(n = 12),后者接受通常的临床护理。 IG进行了一次家访和三次电话采访。我们通过电子监测(EM)评估了九个月期间的药物摄入量(三个月干预,六个月随访)中的NAH。结果:18例患者中有5例退出。纳入研究导致头三个月的两组NAH均显着降低(IG chi(2)= 3.97,df = 1,p = 0.04; EUCG chi(2)= 3.40,df = 1,p = 0.06)。 IG在三个月后显示出NAH的最大降低,尽管这没有达到统计学显着性(在90 d时,chi(2)= 1.05,df = 1,p = 0.31)。此后,两组的NAH逐渐增加,在六个月的随访结束时(即九个月)达到可比较的水平。结论:我们的发现提示有包容作用。尽管在该试验性RCT中的干预措施似乎在药物依从性方面进一步增加了益处,但缺乏统计能力使我们无法做出有力的统计声明。

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