Related Experiment Video
Updated: Dec 30, 2025
The Dyspepsia Educational Tool As a Novel Aid in Dyspepsia Management
Published on: June 29, 2019
Validation of a new tool for evaluating subjects' satisfaction with medicine package leaflets: a cross-sectional
Carla Pires1, Pedro Joel Rosa2, Marina Vigário3
1PhD. Pharmacist and Invited Professor, Department of Pharmacotherapy, Research Center for Biosciences and Health Technologies (CBIOS), Universidade Lusófona, Campo Grande, Lisbon, Portugal.
Background:
Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce.
Objective:
To validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL).
Design And Setting:
Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre).
Methods:
503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett's sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler's Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability.
Results:
Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler's Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous.
Conclusion:
LiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.
More Related Videos
Related Concept Videos
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:29Assessment of the Gastrointestinal System II: Health Perception Pattern
Health Perception Patterns
Health perception patterns offer valuable insights into a patient's lifestyle habits and how they may impact their GI health. These patterns include:
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
02:07Blind Procedures
01:15Drug Dosage Regimen: Overview
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...