Significant work goes into developing a clinical outcome assessment that can be considered “fit for purpose” and, with questionnaires having traditionally been developed on paper, it is important this work is not jeopardized in the migration to new modalities. It’s equally as important to consider the process as a whole before implementation begins to ensure success and to minimize the risk of introducing any response bias on the new modality.
The following checklist outlines the core steps that study teams should take for successful migration of a questionnaire from paper to electronic.
- Contact the instrument author to check for permission and any existing electronic requirements or instructions
Acquire a license, as it is often necessary to use an instrument in a clinical trial. In some cases, the author may already have specific requirements for how migration to eCOA is done.
- Review the original mode to consider any necessary changes
Change words like ‘circle’ to ‘select.’ This is a minor but potentially necessary change for full patient comprehension and ease of use. More significant changes, such as the content of the questions or instructions, should, as a rule, be avoided. However, if there is a valid reason for such updates (for example removing skip logic instructions) the changes should be reviewed and confirmed with the instrument owner.
- Establish requirements / detail how the questionnaire will be migrated
Ensure a full understanding of requirements and any potential changes and lay out the plan for migration. A strong plan mitigates risks of introducing errors and ensures you meet the delivery timeline.
- Create screen shots and relevant scripts (get input from the author if possible)
Draft screens to create a questionnaire layout that is easy for patients to use. Review with the instrument author where possible and when necessary.
- Oversee localization and linguistic validation requirements
Consider clarity, cultural relevance and comprehension when translating COAs to ensure all words and phrases are correctly interpreted. Recommended by ISPOR Taskforce and the FDA for any PRO, study teams risk their submissions being rejected if proper translation methods are not followed. Additionally, localization can also impact design; for example, it is likely that translated text will require more space than English.
- Perform cognitive debriefing and usability testing, if needed
Conduct usability testing early-on to uncover potential issues that patients experience when interacting with the hardware and software. In some instances, electronic validation is recommended to demonstrate patients are interpreting and responding to the electronic version in the same way as the original paper version.
- Analyze results of the testing and cognitive interviews
Experience indicates that best practice would be to record and transcribe one-hour interviews with at least 10 patients (one-on-one) who are as closely matched to the trial population as possible. While a faithful and high quality migration is unlikely to turn up any issues, it is important any feedback is addressed before the study goes live.
- Provide recommendations (if any) for changes to the original script
Analyze respondents’ interpretations and use to discover ambiguous wording, difficult questions, problematic response options and other issues.
- Present the results to the instrument author
Changes to wording of existing, validated questionnaires, are unlikely to be appropriate. However, it is important to share any findings with instrument owners, who are the experts with their particular questionnaire, to gain their feedback on what would be a useful update.
- Deploy final, electronic version of the questionnaire
You’ve done it! Start your trial with the Electronic Clinical Outcome Assessment you’ve created.
What do you think? Are there any additional steps or tips you'd recommend to your peers? Comment below.
Click here to download a quick reference regarding these steps.
For more details surrounding the migration process, download our eBook on Migrating from Paper to eCOA