Designing an ePRO questionnaire involves understanding participant experiences, ensuring accessibility, and optimizing data quality. These best practices will help create effective ePRO questionnaires that engage participants and facilitate meaningful data collection.

Clarity and Simplicity

• Use Simple Language: Write questions in plain language to ensure they are easily understood by participants from varying educational backgrounds. Avoid medical jargon unless it is clearly explained.
• Be Specific and Concise: Questions should be specific to avoid ambiguous answers and concise to keep participants engaged. Long and complex questions can lead to survey fatigue.

Question Structure

• Question Types: Use a mix of question types (e.g., single choice, Likert scales, visual analog scales) to maintain participant interest and obtain necessary data. However, be consistent with the structure to avoid confusing participants.
• Logical Flow: Arrange questions in a logical order that follows the participant’s thought process or chronology of events. This helps maintain a natural flow and reduces cognitive strain.
• Conditional Display: Utilize conditional logic to display or hide questions based on previous answers. For example, skip questions about smoking habits if a participant indicates they do not smoke. This approach streamlines the questionnaire, improving participant experience and data relevance.

Built-in Features for Improved Patient Experience

• Responsive Design: EasyMedStat ePRO questionnaires are responsive by design, ensuring they are accessible and navigable on any device without additional modifications.
• Progress Indicators: A built-in progress bar shows participants how much of the questionnaire they have completed and how much remains, helping decrease dropout rates.
• Estimated Duration: Enable the "Show estimated duration" feature to inform participants about the expected time commitment, setting clear expectations and enhancing the completion rate.

Data Privacy and Security

• Ensure Anonymity and Confidentiality: Clearly communicate to participants how their data will be used and stored, what measures are in place to protect their privacy, and how anonymity (if applicable) will be maintained.
• Built-in Consent Checkbox: The questionnaire includes a built-in checkbox that participants must check to confirm their willingness to provide data. However, researchers should be aware that this alone does not ensure compliance with all ethical guidelines and data protection regulations. Depending on the nature of the study, a specific research consent form may be required in addition to this checkbox to fully comply with legal and ethical standards.

Testing and Validation

• Pilot Testing: Conduct a pilot test with a sample of the target population before deploying the questionnaire. Use this test to identify ambiguities, technical issues, and questions that do not perform as expected.
• Iterative Refinement: 

1. Pre-Launch Adjustments: Utilize feedback from pilot testing to refine questions and the overall structure of the questionnaire before the study officially begins.
2. Protocol Constraints: Once the study has started, changes to the questionnaire might be restricted depending on the study protocol. Document any changes made and the reasons for these changes, which might need ethical approval or amendments to the study protocol.
3. Continuous Feedback Loop: Collect ongoing feedback even if changes to the questionnaire are not possible once the study has started. This is valuable for future studies or subsequent phases of the current study.

Conclusion

Effective ePRO questionnaire design is essential for collecting high-quality data that can lead to meaningful insights in clinical research. By following these best practices and utilizing EasyMedStat's built-in features, researchers can enhance participant engagement, minimize errors, and ensure the success of their studies.