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Assessing comprehension of clinical research
Lianna R Lipton1, Nanette Santoro, Hugh Taylor
1Department of Obstetrics, Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, NY, USA.
Contemporary Clinical Trials
|May 17, 2011
Summary
Participant comprehension of menopausal hormone therapy (MHT) concepts improved over time in a multi-center trial. Ongoing reinforcement of study details is crucial for women with lower education and income.
Area of Science:
- Women's Health Research
- Clinical Trial Methodology
- Participant Education
Background:
- Participant comprehension and retention of study information are critical but understudied aspects of clinical research.
- This is particularly relevant in women's health research, including menopausal hormone therapy (MHT).
Purpose of the Study:
- To assess participant comprehension of key menopausal hormone therapy (MHT) concepts.
- To evaluate the retention of this information over time.
- To identify factors influencing participant comprehension.
Main Methods:
- A 9-item participant comprehension questionnaire (PCQ) was administered at baseline to 151 participants in a multi-center MHT trial.
- The PCQ was re-administered to 71 participants at one site for retention assessment.
- Multivariable analyses examined predictors of comprehension, adjusting for demographic and clinical factors.
Main Results:
- Baseline comprehension was influenced by age, marital status, education, dyspareunia, season of enrollment, and annual family income (AFI).
- A significant improvement in correct responses was observed at follow-up compared to baseline (p = 0.02).
- Lower AFI (<$20,000) and season of enrollment predicted a higher likelihood of answering fewer than 5 out of 9 questions correctly at follow-up.
Conclusions:
- Participant comprehension questionnaires (PCQ) are valuable tools for identifying needs for ongoing reinforcement of study information.
- Symptomatic early menopausal women with lower education and income require particular attention.
- Improved comprehension at follow-up demonstrates successful communication of study concepts in longitudinal research.
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