Article type
Abstract
Background
Medication treatment satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. However, there is no generic and validated instrument for pediatric patients’ M-TS.
Objectives
To develop and prevalidate a self-report and generic Medication Treatment Satisfaction Instrument for Children and Teenagers aged 8-18 with chronic disease (MTSI-CT).
Methods
A 3-phase, mixed-methods, observational study was performed. Patients (8-18 years old) with chronic disease and treated with medication for more than 1 week were eligible to participate. Phase I involved systematic reviews and semistructured interviews to establish a conceptual framework and item pools. Phase II utilized the Delphi method and the cognitive interview to assess the relevance, comprehensibility, and comprehensiveness of the initial instrument. Phase III involves testing the instrument on a larger sample of pediatric patients to confirm its measurement properties and feasibility.
Results
The review identified 69 M-TS patient-reported outcome measures (PROMs) (4 generic, 32 disease-specific, and 33 drug-specific; 60 for adults). We conducted semistructured interviews with 15 patients and 11 experts (pediatricians, pharmacists, nurses, psychologists, and PROM methodologists), Delphi methods with 14 experts and cognitive interviews with 10 patients. We conducted a single-center, prevalidation study in China and recruited 113 pediatric patients who met the inclusion criteria. The instrument achieved a response rate and completion rate of 100%, with a completion time of 2-8 minutes, indicating good feasibility. Exploratory factor analysis was conducted on the 22 items, resulting in a proposed model consisting of 8 domains. The instrument demonstrated sufficient content validity (high-quality evidence) and internal consistency (high-quality evidence). Discriminate validity was demonstrated between the 25% of subjects with the lowest scores and the 25% with the highest scores. The MTSI-CT had 6 multi-item domains (effectiveness, safety, impact on health-related quality of life, ease and convenience, information and involvement in treatment decision-making, and access and cost) and 2 single items (medication shame and global satisfaction). We are conducting further multicenter validation studies to assess the validity and reliability of the MTSI-CT.
Conclusions
The MTSI-CT has strong psychometric properties and feasibility, making it useful for promoting rational medication use in pediatrics in both clinical and academic settings.
Medication treatment satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. However, there is no generic and validated instrument for pediatric patients’ M-TS.
Objectives
To develop and prevalidate a self-report and generic Medication Treatment Satisfaction Instrument for Children and Teenagers aged 8-18 with chronic disease (MTSI-CT).
Methods
A 3-phase, mixed-methods, observational study was performed. Patients (8-18 years old) with chronic disease and treated with medication for more than 1 week were eligible to participate. Phase I involved systematic reviews and semistructured interviews to establish a conceptual framework and item pools. Phase II utilized the Delphi method and the cognitive interview to assess the relevance, comprehensibility, and comprehensiveness of the initial instrument. Phase III involves testing the instrument on a larger sample of pediatric patients to confirm its measurement properties and feasibility.
Results
The review identified 69 M-TS patient-reported outcome measures (PROMs) (4 generic, 32 disease-specific, and 33 drug-specific; 60 for adults). We conducted semistructured interviews with 15 patients and 11 experts (pediatricians, pharmacists, nurses, psychologists, and PROM methodologists), Delphi methods with 14 experts and cognitive interviews with 10 patients. We conducted a single-center, prevalidation study in China and recruited 113 pediatric patients who met the inclusion criteria. The instrument achieved a response rate and completion rate of 100%, with a completion time of 2-8 minutes, indicating good feasibility. Exploratory factor analysis was conducted on the 22 items, resulting in a proposed model consisting of 8 domains. The instrument demonstrated sufficient content validity (high-quality evidence) and internal consistency (high-quality evidence). Discriminate validity was demonstrated between the 25% of subjects with the lowest scores and the 25% with the highest scores. The MTSI-CT had 6 multi-item domains (effectiveness, safety, impact on health-related quality of life, ease and convenience, information and involvement in treatment decision-making, and access and cost) and 2 single items (medication shame and global satisfaction). We are conducting further multicenter validation studies to assess the validity and reliability of the MTSI-CT.
Conclusions
The MTSI-CT has strong psychometric properties and feasibility, making it useful for promoting rational medication use in pediatrics in both clinical and academic settings.