Identification and assessment of adherence-enhancing interventions in studies assessing medication adherence through electronically compiled drug dosing histories: a systematic literature review and meta-analysis.
Identification and assessment of adherence-enhancing interventions in studies assessing medication adherence through electronically compiled drug dosing histories: a systematic literature review and meta-analysis.
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DOI：
10.1007/s40265-013-0041-3
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发表时间：
2013-05
期刊：
影响因子：
11.5
通讯作者：
Vrijens, Bernard
中科院分区：
文献类型：
--
作者：
Demonceau, Jenny;Ruppar, Todd;Kristanto, Paulus;Hughes, Dyfrig A.;Fargher, Emily;Kardas, Przemyslaw;De Geest, Sabina;Dobbels, Fabienne;Lewek, Pawel;Urquhart, John;Vrijens, Bernard
不坚持服药在包括门诊药物治疗在内的所有医疗条件下都很普遍，因此是实现其他有效药物益处的主要障碍。本系统综述的目的是基于对综合试验效应量的定量评估，确定并比较改善处方药给药方案实施并保持长期持久性的策略及其组成部分的疗效。MEDLINE、EMBASE、CINAHL、Cochrane图书馆和PsycINFO系统地检索了随机对照试验，以测试自我给药的依从性增强策略的有效性。检索限于从数据库建立到2011年12月31日的英文论文。我们的综述包括随机对照试验，这些试验的依从性是通过电子编制的药物给药史来评估的。共筛选了5400项研究。资格评估由两名审稿人独立进行。制定了结构化数据收集表，从每个研究中提取数据。黏附增强成分分为8类。采用Cochrane干预措施系统评价手册指南的标准评估论文的质量，以评估潜在的偏倚。通过按预先定义的顺序（正确给药、服药、服药时间、服药患者百分比）从研究中可用的不同依从性变量中提取可用的依从性摘要变量，得出综合依从性结果。为了研究依从性增强成分及其对依从性的影响之间的关系，我们基于平均依从性点估计建立了线性元回归模型，并进行了meta分析。1995年至2011年12月期间发表的79项临床试验纳入了该综述。随机分配到干预组的患者的平均联合依从性为74.3%，比随机分配到对照组的患者（60.2%）高出14.1%。采用逐步变量选择的线性元回归分析估计，当干预包括对患者近期给药史的反馈（EM-feedback）时，依从性增加8.8% (p < 0.01)，当干预包括认知教育成分时，依从性增加5.0% （p = 0.02）。此外，干预措施对依从性的影响每月下降1.1%。仅选取高质量论文进行敏感性分析，证实了模型的稳健性。meta分析中的随机效应模型对48项研究进行了分析，证实了上述发现，并显示接受电磁反馈的患者的依从性改善为19.8% (95% CI 10.7 - 28.9%)，几乎是未包括这种反馈的研究的依从性改善的两倍[10.3% (95% CI 7.5 - 13.1%)] （p < 0.01）。在测试认知教育成分的研究中，依从性的改善为16.1% (95% CI 10.7 - 21.6%)，而在不包括这种干预的研究中，依从性的改善为10.1% (95% CI 6.6 - 13.6%) （p = 0.04）。在测量临床结果的57项研究中，只有8项报告了临床结果的显著改善。尽管采用了通用的测量方法，但meta分析受到汇总数据的异质性和药物依从性的不同测量方法的限制。漏斗图显示，在干预效果具有高度可变性的研究中，可能存在发表偏倚。尽管已确定的研究之间存在统计异质性和潜在的发表偏倚，但我们的荟萃分析的证据表明，em反馈和认知教育干预是增强患者对药物依从性的潜在有效方法。本研究的局限性突出了迫切需要为研究方案定义指南和研究特征，以指导研究人员设计研究以评估依从性增强干预措施的效果。本文的在线版本（doi:10.1007/s40265-013-0041-3）包含补充材料，仅供授权用户使用。
Non-adherence to medications is prevalent across all medical conditions that include ambulatory pharmacotherapy and is thus a major barrier to achieving the benefits of otherwise effective medicines. The objective of this systematic review was to identify and to compare the efficacy of strategies and components thereof that improve implementation of the prescribed drug dosing regimen and maintain long-term persistence, based on quantitative evaluation of effect sizes across the aggregated trials. MEDLINE, EMBASE, CINAHL, the Cochrane Library, and PsycINFO were systematically searched for randomized controlled trials that tested the efficacy of adherence-enhancing strategies with self-administered medications. The searches were limited to papers in the English language and were included from database inception to 31 December 2011. Our review included randomized controlled trials in which adherence was assessed by electronically compiled drug dosing histories. Five thousand four hundred studies were screened. Eligibility assessment was performed independently by two reviewers. A structured data collection sheet was developed to extract data from each study. The adherence-enhancing components were classified in eight categories. Quality of the papers was assessed using the criteria of the Cochrane Handbook for Systematic Reviews of Interventions guidelines to assess potential bias. A combined adherence outcome was derived from the different adherence variables available in the studies by extracting from each paper the available adherence summary variables in a pre-defined order (correct dosing, taking adherence, timing adherence, percentage of adherent patients). To study the association between the adherence-enhancing components and their effect on adherence, a linear meta-regression model, based on mean adherence point estimates, and a meta-analysis were conducted. Seventy-nine clinical trials published between 1995 and December 2011 were included in the review. Patients randomized to an intervention group had an average combined adherence outcome of 74.3 %, which was 14.1 % higher than in patients randomized to the control group (60.2 %). The linear meta-regression analysis with stepwise variable selection estimated an 8.8 % increase in adherence when the intervention included feedback to the patients of their recent dosing history (EM-feedback) (p < 0.01) and a 5.0 % increase in adherence when the intervention included a cognitive-educational component (p = 0.02). In addition, the effect of interventions on adherence decreased by 1.1 % each month. Sensitivity analysis by selecting only high-quality papers confirmed the robustness of the model. The random effects model in the meta-analysis, conducted on 48 studies, confirmed the above findings and showed that the improvement in adherence was 19.8 % (95 % CI 10.7–28.9 %) among patients receiving EM-feedback, almost double the improvement in adherence for studies that did not include this type of feedback [10.3 % (95 % CI 7.5–13.1 %)] (p < 0.01). The improvement in adherence was 16.1 % (95 % CI 10.7–21.6 %) in studies that tested cognitive-educational components versus 10.1 % (95 % CI 6.6–13.6 %) in studies that did not include this type of intervention (p = 0.04). Among 57 studies measuring clinical outcomes, only 8 reported a significant improvement in clinical outcome. Despite a common measurement, the meta-analysis was limited by the heterogeneity of the pooled data and the different measures of medication adherence. The funnel plot showed a possible publication bias in studies with high variability of the intervention effect. Notwithstanding the statistical heterogeneity among the studies identified, and potential publication bias, the evidence from our meta-analysis suggests that EM-feedback and cognitive-educational interventions are potentially effective approaches to enhance patient adherence to medications. The limitations of this research highlight the urgent need to define guidelines and study characteristics for research protocols that can guide researchers in designing studies to assess the effects of adherence-enhancing interventions. The online version of this article (doi:10.1007/s40265-013-0041-3) contains supplementary material, which is available to authorized users.
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