背景:了解患者对服用片剂或胶囊制剂的偏好在治疗效果和依从性中起着关键作用。因此,在设计配方和处方时,应考虑这些偏好。
目的:本研究调查了吞咽大片或胶囊有困难的患者对患者偏好的影响因素,旨在确定片剂和胶囊的合适尺寸。
方法:基于2022年12月1日至2022年12月7日进行的问卷调查,使用harmoCo运营的harmo智能手机应用程序,开发了一个强大的数据集该数据集包括患者关于他们的片剂和胶囊偏好的输入,个人健康记录(包括配药史),和药物配方信息(可从包装说明书中获得)。根据药物配方信息,对由于大尺寸和伴随的片剂或胶囊(用作对照)而被认为难以吞咽的各片剂或胶囊设定6个指数。接收器工作特性(ROC)分析用于评估每个指标的性能。选择显示ROC曲线下最高面积的指数作为确定导致吞咽困难的片剂或胶囊尺寸的最佳指数。从生成的ROC中,确定了使Youden指数最大化的具有最高判别性能的点,并计算了每个指标的最佳阈值。进行多因素logistic回归分析以确定导致吞服超大片剂或胶囊困难的危险因素。此外,进行了决策树分析,从几个因素估计综合风险,使用多因素logistic回归分析中显著的危险因素.
结果:本研究分析了147个大片剂或胶囊和624个对照片剂或胶囊。“长直径+短直径+厚度”指数(阈值为21.5mm)被确定为导致患者吞咽困难的最佳指标。多因素logistic回归分析(包括132例吞咽困难患者和1283例没有吞咽困难患者)结果确定了以下促成性危险因素:年龄<50岁(比值比[OR]1.59,95%CI1.03-2.44),女性(OR2.54,95%CI1.70-3.78),吞咽困难(OR3.54,95%CI2.22-5.65),并服用大片剂或胶囊(OR9.74,95%CI5.19-18.29)。决策树分析结果表明,服用大片剂或胶囊的患者吞咽困难的风险增加。
结论:这项研究确定了最合适的指标和阈值,以表明给定的片剂或胶囊大小会导致吞咽困难。以及共同的风险因素。尽管一些采样偏差(例如,仅包括智能手机用户)可能存在,我们的结果可以指导患者友好的配方和处方的设计,促进更好的药物依从性。
BACKGROUND: Understanding patient preference regarding taking tablet or capsule formulations plays a pivotal role in treatment efficacy and adherence. Therefore, these preferences should be taken into account when designing formulations and prescriptions.
OBJECTIVE: This study investigates the factors affecting patient preference in patients who have difficulties swallowing large tablets or capsules and aims to identify appropriate sizes for tablets and capsules.
METHODS: A robust data set was developed based on a questionnaire survey conducted from December 1, 2022, to December 7, 2022, using the harmo smartphone app operated by harmo Co, Ltd. The data set included patient input regarding their tablet and capsule preferences, personal health records (including dispensing history), and drug formulation information (available from package inserts). Based on the medication formulation information, 6 indices were set for each of the tablets or capsules that were considered difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) analysis was used to evaluate the performance of each index. The index demonstrating the highest area under the curve of the ROC was selected as the best index to determine the tablet or capsule size that leads to swallowing difficulties. From the generated ROCs, the point with the highest discriminative performance that maximized the Youden index was identified, and the optimal threshold for each index was calculated. Multivariate logistic regression analysis was performed to identify the risk factors contributing to difficulty in swallowing oversized tablets or capsules. Additionally, decision tree analysis was performed to estimate the combined risk from several factors, using risk factors that were significant in the multivariate logistic regression analysis.
RESULTS: This study analyzed 147 large tablets or capsules and 624 control tablets or capsules. The \"long diameter + short diameter + thickness\" index (with a 21.5 mm threshold) was identified as the best indicator for causing swallowing difficulties in patients. The multivariate logistic regression analysis (including 132 patients with swallowing difficulties and 1283 patients without) results identified the following contributory risk factors: aged <50 years (odds ratio [OR] 1.59, 95% CI 1.03-2.44), female (OR 2.54, 95% CI 1.70-3.78), dysphagia (OR 3.54, 95% CI 2.22-5.65), and taking large tablets or capsules (OR 9.74, 95% CI 5.19-18.29). The decision tree analysis results suggested an elevated risk of swallowing difficulties for patients with taking large tablets or capsules.
CONCLUSIONS: This study identified the most appropriate index and threshold for indicating that a given tablet or capsule size will cause swallowing difficulties, as well as the contributory risk factors. Although some sampling biases (eg, only including smartphone users) may exist, our results can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence.