Gossec Laure, Tubach Florence, Dougados Maxime, Ravaud Philippe
AP-HP, Rheumatology B Department, Cochin Hospital, 27 rue du faubourg St Jacques, Paris 5 University, Paris, France.
Am J Med Sci. 2007 Oct;334(4):248-54. doi: 10.1097/MAJ.0b013e318068dde8.
International recommendations such as the CONSORT and International Conference on Harmonisation statements recognize patient adherence to prescribed treatment as an important aspect of a treatment's evaluation, but this issue is little assessed.
To evaluate how medication adherence was assessed and reported in recently published randomized controlled trials (RCTs).
All publications of RCTs assessing pharmacological treatments in 6 major chronic diseases published in high-impact-factor journals in 2003 and 2004 were selected from the Medline database. Two investigators analyzed how medication adherence was assessed and reported.
A total of 192 publications were analyzed: 71 in HIV infection, 48 diabetes mellitus, 24 rheumatoid arthritis, 23 asthma, 15 hypertension, 7 osteoporosis, and 4 about 2 of these diseases. The assessment of medication adherence was documented in 69 (35.9%) publications, by counting pill intake in half of these. Results of adherence were reported in 64 (33.3%) publications. Adherence was reported as a quantitative measure: Proportion of the treatment prescribed in 27 articles and as a qualitative measure (adherent patient, yes/no) in 41 (in 4 reports both techniques were used). When reported, the median intake of prescribed medication was 93%, and the median proportion of "nonadherent" patients was 6.2%.
There is important variability in the assessment and reporting of medication adherence in published RCTs of pharmacological treatments of selected chronic diseases, for a given disease and across diseases. Standardization is advisable to allow for comparisons among studies.
诸如CONSORT声明和国际协调会议声明等国际建议都认为患者对规定治疗的依从性是治疗评估的一个重要方面,但这个问题很少得到评估。
评估在最近发表的随机对照试验(RCT)中药物依从性是如何被评估和报告的。
从Medline数据库中选取2003年和2004年发表在高影响因子期刊上的评估6种主要慢性病药物治疗的所有RCT出版物。两名研究人员分析了药物依从性是如何被评估和报告的。
共分析了192篇出版物:71篇关于HIV感染,48篇关于糖尿病,24篇关于类风湿性关节炎,23篇关于哮喘,15篇关于高血压,7篇关于骨质疏松症,4篇涉及其中两种疾病。69篇(35.9%)出版物记录了药物依从性的评估情况,其中一半是通过计算药丸摄入量来评估的。64篇(33.3%)出版物报告了依从性结果。依从性报告为定量指标:27篇文章中为规定治疗的比例,41篇文章中为定性指标(依从患者,是/否)(4篇报告同时使用了这两种方法)。当报告时,规定药物的中位摄入量为93%,“不依从”患者的中位比例为6.2%。
在已发表的所选慢性病药物治疗RCT中,对于特定疾病以及不同疾病之间,药物依从性的评估和报告存在很大差异。建议进行标准化以便于各研究之间的比较。