Bergsbaken J J, Eickhoff J C, Buss B A, Mably M S, Kolesar J M
Department of Pharmacy, University of Wisconsin Hospital and Clinics, Madison, USA.
Department of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Population Health, Madison, USA.
J Oncol Pharm Pract. 2016 Feb;22(1):105-13. doi: 10.1177/1078155214567163. Epub 2015 Jan 10.
Despite recommendations for adherence reporting in clinical trials involving an oral anticancer agent, the frequency and methods of adherence reporting are inconsistent. The purpose of this systematic review is to determine the frequency and type of adherence measures used in oncology and hematology clinical trials of oral anticancer agents and their association with study characteristics including quality, cancer type, stage and treatment type.
PubMed was searched of all randomized controlled clinical trials assessing self-administered pharmacological interventions in patients with cancer and published over two years, between 1 January 2011 and 31 December 2012 were evaluated.
We identified 70 publications in the PubMed database, comprising 45,118 total patients. Adherence reporting was present in 14 of 70 trials (20%); quantitative reporting was present in three of 70 trials (4%). Method of adherence assessment varied and included medication count, medication diaries and patient self-report. There was no association between adherence reporting and study quality or other study characteristics, although there was a trend towards increased reporting in breast cancer studies, with 46% of the studies reporting adherence (p = 0.0621). In a preliminary analysis, hematology studies (mean Jadad score 2.19 ± 1.47) were found to have significantly lower quality when compared to non-hematology trials (mean Jadad score 3.39 ± 1.37, p = 0.0034).
This systematic review demonstrates adherence reporting in clinical trials of oral anticancer agents is infrequent. When reported, adherence was not associated with overall study quality or other study characteristics. Given the potential effects of non-adherence on study power and validity, adherence reporting should be encouraged in oncology and hematology clinical trials.
尽管在涉及口服抗癌药物的临床试验中有关于依从性报告的建议，但依从性报告的频率和方法并不一致。本系统评价的目的是确定在口服抗癌药物的肿瘤学和血液学临床试验中使用的依从性测量的频率和类型，以及它们与研究特征（包括质量、癌症类型、分期和治疗类型）之间的关联。
检索PubMed中2011年1月1日至2012年12月31日期间发表的、评估癌症患者自我给药药物干预的所有随机对照临床试验，对超过两年发表的进行评估。
我们在PubMed数据库中识别出70篇出版物，共涉及45118名患者。70项试验中有14项（20%）报告了依从性；70项试验中有3项（4%）进行了定量报告。依从性评估方法各不相同，包括药物计数、用药日记和患者自我报告。依从性报告与研究质量或其他研究特征之间没有关联，尽管乳腺癌研究中有增加报告的趋势，46%的研究报告了依从性（p = 0.0621）。在初步分析中，发现血液学研究（平均Jadad评分2.19±1.47）与非血液学试验相比质量显著较低（平均Jadad评分3.39±1.37，p = 0.0034）。
本系统评价表明，口服抗癌药物临床试验中的依从性报告很少见。当报告依从性时，其与总体研究质量或其他研究特征无关。鉴于不依从对研究效能和有效性的潜在影响，肿瘤学和血液学临床试验应鼓励报告依从性。
