Online sleep diaries: considerations for system development and recommendations for data management.

STUDY OBJECTIVES

To present development considerations for online sleep diary systems that result in robust, interpretable, and reliable data; furthermore, to describe data management procedures to address common data entry errors that occur despite those considerations.

METHODS

The online sleep diary capture component of the Sleep Healthy Using the Internet (SHUTi) intervention has been designed to promote data integrity. Features include diary entry restrictions to limit retrospective bias, reminder prompts and data visualizations to support user engagement, and data validation checks to reduce data entry errors. Despite these features, data entry errors still occur. Data management procedures relying largely on programming syntax to minimize researcher effort and maximize reliability and replicability. Presumed data entry errors are identified where users are believed to have incorrectly selected a date or AM versus PM on the 12-hour clock. Following these corrections, diaries are identified that have unresolvable errors, like negative total sleep time.

RESULTS

Using the example of one of our fully-powered, U.S. national SHUTi randomized controlled trials, we demonstrate the application of these procedures: of 45,598 total submitted diaries, 487 diaries (0.01%) required modification due to date and/or AM/PM errors and 27 diaries (<0.001%) were eliminated due to unresolvable errors.

CONCLUSION

To secure the most complete and valid data from online sleep diary systems, it is critical to consider the design of the data collection system and to develop replicable processes to manage data.

CLINICAL TRIAL REGISTRATION

Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness (SHUTiOASIS); https://clinicaltrials.gov/ct2/show/NCT03213132; ClinicalTrials.gov ID: NCT03213132.