JMIR Publications

ABSTRACT

Background:

Background:

Understanding the preferences of the patients regarding taking tablet or capsule formulations plays a pivotal role in the effective and correct use of pharmaceuticals. Therefore, for optimal medication adherence, these preferences should be taken into account in the design of formulations and prescriptions.

Objective:

Objective:

This study investigates the appropriate size of tablets or capsules and the factors affecting the preference of patients who find difficulties in swallowing tablets or capsules because of their large size.

Methods:

Methods:

A robust dataset was developed based on a questionnaire survey conducted from December 1 to 7, 2022, using the harmo smartphone application operated by harmo Co.,Ltd (Tokyo, Japan). The dataset encompassed input from patients regarding their tablet and capsule preferences, personal health records, including dispensing history, and drug formulation information (available in package inserts). Based on the medication formulation information, six indices were set for each of the tablets or capsules that were difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) was employed to evaluate the performance of each index. The index demonstrating the highest area under the curve (AUC) of the ROC was selected as the best index to determine the size of tablets or capsules that cause swallowing difficulties. From the ROCs generated, 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 the challenges encountered by the patients who find difficulty in swallowing oversized tablets or capsules. Additionally, a decision tree analysis was performed using risk factors that were significant in the multivariate logistic regression analysis to estimate the risk of a combination of multiple factors.

Results:

Results:

The 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 assessing the size of tablets or capsules causing swallowing difficulties in patients. Multivariate logistic regression analysis including 132 patients with swallowing difficulties and 1,283 patients without identified the risk factors: age <50 years [odds ratio (OR):1.59, 95% confidence interval (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 prescription of large tablets or capsules [OR:9.74, 95%CI:5.19–18.29]. Decision tree analysis suggested an elevated risk of difficulty in swallowing large tablets or capsules for patients with dysphagia.

Conclusions:

Conclusions:

This study identified the most appropriate index and threshold for assessing the size of tablets or capsules causing swallowing difficulties, as well as the crucial risk factors. The insights can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence.