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ePRO (electronic Patient-Reported Outcome) refers to the use of digital devices, such as smartphones, tablets or computers, to collect patient-reported data in clinical trials. The main value proposition for using ePRO in clinical studies includes:

  1. Improved accuracy and completeness: ePRO eliminates handwriting errors and allows patients to provide more detailed answers, which can lead to more accurate data.
  2. Increased efficiency: ePRO reduces data entry time and eliminates the need for manual data transfer, making the data collection process faster and more efficient.
  3. Enhanced patient engagement: ePRO provides a more convenient and user-friendly experience for patients, which can improve their engagement and motivation to participate in the study.
  4. Real-time data collection: ePRO allows for real-time data collection, reducing the time lag between data collection and analysis.
  5. Increased data security: ePRO provides secure data storage and transfer, reducing the risk of data loss or breaches.

The advantage of adding patient input from ePRO in combination with data collected by the site is that it provides a more comprehensive view of the patient’s experience and health status.

By combining ePRO data with data collected by the site, such as objective measures of disease activity and physiological data, researchers can gain a better understanding of the patient’s experience, including their symptoms, quality of life, and treatment adherence. This can help to provide a more complete picture of the patient’s overall health and treatment response.

Additionally, ePRO data can provide valuable insights into patient-reported outcomes, such as their experience with side effects or symptoms that may not be captured through traditional clinical measures. This information can help researchers to identify and address any issues that may impact the patient’s experience and can provide valuable feedback to improve the design and implementation of future clinical trials.

In conclusion, adding patient input from ePRO in combination with data collected by the site provides a more comprehensive and accurate picture of the patient’s health status and treatment response, which can inform clinical decision-making and improve patient outcomes.

Here are some best practices for implementing patient surveys and questionnaires in ePRO for a clinical study:

  1. Clear and concise questions: Use clear and concise language to ask questions and avoid overly complex or lengthy questionnaires. This can help to reduce confusion and ensure that patients understand what is being asked of them.
  2. Validate the questions: Validate the questions used in the ePRO system to ensure that they are accurate, relevant, and appropriate for the study population. This can help to improve the reliability and validity of the data collected.
  3. Data security: Ensure that the ePRO system is secure, and that patient data is protected against unauthorized access or loss. This can help to maintain patient privacy and ensure that data is handled in a responsible manner.
  4. Technical support: Provide technical support to patients in case they experience any issues with the ePRO system. This can help to ensure that patients are able to use the system effectively and provide high-quality data.
  5. Ongoing monitoring and feedback: Monitor the ePRO system regularly and provide feedback to patients on their progress. This can help to identify any issues early on and ensure that patients are motivated to continue providing high-quality data throughout the study.

By following these best practices, you can help to ensure that the patient surveys and questionnaires implemented in ePRO are effective, efficient, and produce high-quality data for your clinical study.

  1. Define the Goals of the Survey: It is important to define the purpose of the survey clearly so that questions and answers can be tailored to achieve the desired results.
  2. Create a Clear and Concise Introduction: The introduction should explain why the survey is being conducted, how long it will take to complete, and whom to contact if the respondent has any questions.
  3. Ask Questions That Are Direct and Easy to Understand: Questions should be direct and not too complicated. Use simple language and avoid using jargon or technical terms.
  4. Include Clear Options in the Questions: Make sure the questions are clear and easy to understand. Include options such as yes/no, multiple choice, and open-ended questions.
  5. Use Formatting to Improve Readability: Use formatting such as bold, italics, and underlining to make the survey easier to read and understand.
  6. Pilot Test the Survey: Before launching the survey, it is important to test it with a small group of people. This will help identify any potential issues or problems with the survey.
  7. Limit the Length of the Survey: Keeping the survey short and to the point will help ensure respondents complete it.
  8. Provide an Incentive for Completing the Survey: Offering an incentive such as a gift card or discount code can help encourage respondents to complete the survey.