A critical evaluation of the methodology of the literature on medication compliance
A critical evaluation of the methodology of the literature on medication compliance
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DOI：
10.1345/aph.18233
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发表时间：
1999-05-01
影响因子：
2.9
通讯作者：
Sung, JCY
中科院分区：
文献类型：
--
作者：
Nichol, MB;Venturini, F;Sung, JCY
目的：开发一种简单的评估工具来评估患者药物依从性文献的方法学严谨性，并将该工具应用于文献样本。方法：计算机检索MEDLINE数据库（1980年1月- 1996年12月）。所有关于药物依从性的英文文章都被识别出来，使用MeSH术语患者依从性和药物治疗。然后随机选择10%的样本进行审查，方法学的严谨性根据8个标准进行评估：研究设计、患者样本规格、功效分析、疾病规格、治疗方案规格、随访时间、依从性定义和依从性测量。8个标准的原始分数被合并成3个总结分数，从0到100进行标准化：研究设计、疾病相关特征和依从性问题。结果：对719篇文献中的72篇进行了综述。大多数研究文章是描述性的（63.9%），这些研究中的患者主要来自方便样本（41.7%）。只有9项研究是多中心研究，3项研究采用了功效分析。依从性定义在41.7%的研究中是可重复的。有22条既没有说明遵守措施，也没有说明标准。四分之一的研究（18项）使用了未经验证的依从性测量。只有两项研究在依从性测量中达到6分，8项研究同时使用了两种不同的依从性测量。总结评分的中位数为：研究设计8.3分，疾病42.9分，依从性问题50分。结论：依从性研究的质量普遍较差。这些低分数反映了方法中非常重要的缺陷，这种疏忽使得读者很难批判性地评估结论的有效性。
OBJECTIVE: To develop a simple evaluation tool to assess methodologic rigor of the literature on patient compliance with medications, and to apply the tool to a sample of the literature.METHODS: A computerized search of the MEDLINE database (January 1980-December 1996) was performed. All English-language articles on compliance with medications were identified, using the MeSH terms patient-compliance and drug-therapy. A 10% sample was then randomly selected for review, Methodologic rigor was assessed on eight standards: study design, specification of patient sample, power analysis, specification of disease, specification of therapeutic regimen, duration of follow-up, definition of compliance, and compliance measurement. The raw scores of the eight standards were then combined in three summary scores, standardized from 0 to 100: study design, disease-related features, and compliance issues.RESULTS: Seventy-two articles from 719 identified were reviewed. The majority of the research articles were descriptive (63.9%), and patients in these studies were selected mainly from a convenience sample (41.7%). Just nine studies were multicenter studies, and three employed power analysis. The compliance definition was replicable in 41.7% of the studies. In 22 articles neither the compliance measure nor the criteria were stated. One-quarter of the studies (18) used a nonvalidated measure of compliance. Only two studies reached a score of 6 in the compliance measure, and eight studies used two different measures of compliance simultaneously. The median values in the summary scores were: study design 8.3, disease 42.9, compliance issues 50.CONCLUSIONS: The quality of the compliance research was generally poor. These low scores reflect very important shortcomings in the methodology, Such oversights make it difficult for the reader to critically assess the validity of the conclusions.