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患者依从性与医学研究:方法学问题

Patient compliance and medical research: issues in methodology.

作者信息

Melnikow J, Kiefe C

机构信息

Department of Family Practice, University of California-Davis.

出版信息

J Gen Intern Med. 1994 Feb;9(2):96-105. doi: 10.1007/BF02600211.

DOI:10.1007/BF02600211
PMID:8164085
Abstract

Compliance with medication and medical appointments is presumed to have a critical influence on outcomes of medical interventions. However, compliance may not always be easily defined or accurately measured. No single method of measuring compliance with appointments or medication is applicable in all settings. The apparent effects of compliance on outcome may be both direct and indirect; research is needed to define more clearly how these effects may be mediated. Identifying effective methods of enhancing compliance requires accurate methods of measuring compliance. In addition, the effectiveness of interventions may decay over time, and differences in effectiveness in acute versus long-term settings have not been well studied. Researchers conducting clinical trials of medical interventions must evaluate compliance in the population studied and consider the potential impact of noncompliance on trial results and their generalizability. In some trial designs, data may best be analyzed by considering compliance a dependent or an outcome variable. Under appropriate circumstances, compliance may be considered an independent variable. Readers of the medical literature should consider how compliance was measured and analyzed when interpreting the results of clinical trials. Table 4 suggests criteria for critical appraisal of compliance-related issues in reports of clinical trials.

摘要

一般认为,药物治疗的依从性和医疗预约的遵守情况对医疗干预的结果具有关键影响。然而,依从性可能并不总是易于定义或准确测量。没有一种单一的方法可用于在所有情况下测量预约或药物治疗的依从性。依从性对结果的明显影响可能是直接的,也可能是间接的;需要开展研究以更清楚地界定这些影响可能是如何介导的。确定提高依从性的有效方法需要准确的依从性测量方法。此外,干预措施的有效性可能会随着时间的推移而衰减,并且急性与长期环境中有效性的差异尚未得到充分研究。开展医疗干预临床试验的研究人员必须评估所研究人群的依从性,并考虑不依从对试验结果及其普遍性的潜在影响。在某些试验设计中,通过将依从性视为因变量或结果变量来分析数据可能最为合适。在适当情况下,依从性可被视为自变量。医学文献的读者在解释临床试验结果时应考虑依从性是如何测量和分析的。表4提出了在临床试验报告中对与依从性相关问题进行批判性评价的标准。

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Patient compliance and medical research: issues in methodology.患者依从性与医学研究:方法学问题
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