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Questionnaires in clinical trials: guidelines for optimal design and administration
1Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. phil.edwards@LSHTM.ac.uk
Trials
|January 13, 2010
Summary
Designing effective clinical trial questionnaires minimizes bias and maximizes treatment effect precision. Careful data collection balances power and reduces follow-up loss, while administration mode impacts cost and data quality.
Area of Science:
- Clinical Trials
- Health Services Research
- Biostatistics
Background:
- Effective questionnaire design is crucial for clinical trials to minimize bias and maximize treatment effect precision.
- Collecting excessive data can reduce participant recruitment and increase losses to follow-up, potentially introducing bias.
- The method of questionnaire administration affects data collection costs, quality, and completeness.
Purpose of the Study:
- To review the impact of questionnaire design on clinical trial outcomes.
- To evaluate strategies for improving data completeness and reducing bias in clinical trials.
- To assess the need for further research into theory-based guidelines for self-administered questionnaires.
Main Methods:
- Literature review on questionnaire design principles in clinical trials.
- Analysis of factors influencing data completeness and quality.
- Discussion of evidence for design features and administration modes.
Main Results:
- Good evidence exists for specific design features that enhance data completeness.
- Further research is needed to evaluate various strategies within the context of clinical trials.
- Theory-based guidelines for self-administered questionnaire style, appearance, and layout require empirical evaluation.
Conclusions:
- Optimizing questionnaire design and administration is key to efficient and reliable clinical trials.
- Balancing data collection with recruitment and follow-up is essential for study validity.
- Continued research is necessary to refine best practices in clinical trial questionnaire development.
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