Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Location VUmc.
Epidemiology & Data Science, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.
Rheumatology (Oxford). 2021 Nov 3;60(11):5239-5246. doi: 10.1093/rheumatology/keab207.
Suboptimal medication adherence is a serious problem in the treatment of chronic inflammatory diseases. To measure medication adherence, electronic monitoring is regarded as superior to pill count. GLORIA is an ongoing two-year trial on the addition of low-dose (5 mg/d) prednisolone or placebo to standard care in older people (65+ years) with RA. During the entire trial, adherence is measured with electronic caps, and with pill counts. The objective is to describe medication adherence patterns, and to compare the adherence results of the two methods.
The recorded adherence patterns of patients (blinded for treatment group) were classified according to descriptive categories. The cutoff for good adherence was set at 80% of prescribed pills taken.
Trial inclusion closed in 2018 at 451 patients, but trial follow-up is ongoing; the current dataset contains adherence data of 371 patients. Mean number of recorded 90-day periods per patient was 4 (range 1-8). Based on pill count over all periods, 90% of the patients had good adherence; based on cap data, only 20%. Cap data classified 30% of patients as non-user (<20% of days an opening) and 40% as irregular user (different adherence patterns, in or between periods).
In our trial of older people with RA, the majority appeared to be adherent to medication according to pill count. Results from caps conflicted with those of pill counts, with patterns suggesting patients did not use the bottle for daily dispensing, despite specific advice to do so.
NCT02585258. ClinicalTrials.gov (https://www.clinicaltrials.gov/).
在慢性炎症性疾病的治疗中，药物依从性差是一个严重的问题。为了衡量药物依从性，电子监测被认为优于药丸计数。GLORIA 是一项为期两年的试验，在标准治疗的基础上，给老年人（65 岁以上）添加低剂量（5 毫克/天）泼尼松龙或安慰剂。在整个试验过程中，通过电子瓶盖和药丸计数来测量依从性。目的是描述药物依从模式，并比较两种方法的依从结果。
根据描述性类别对患者（对治疗组设盲）的记录依从模式进行分类。将良好依从性的截止值设定为服用规定药丸的 80%。
试验于 2018 年纳入了 451 名患者，但试验仍在继续；目前的数据集中包含了 371 名患者的依从性数据。每位患者记录的 90 天周期的平均数量为 4 个（范围为 1-8 个）。根据所有周期的药丸计数，90%的患者具有良好的依从性；根据帽数据，只有 20%。帽数据将 30%的患者归类为非使用者（<20%的天数有开口）和 40%的不规则使用者（不同的依从模式，在或在周期之间）。
在我们的老年类风湿关节炎患者试验中，根据药丸计数，大多数患者似乎是依从药物的。帽数据与药丸计数的结果相冲突，表明患者没有按照建议每天从瓶中取出药丸。
NCT02585258。ClinicalTrials.gov（https://www.clinicaltrials.gov/）。
