OBJECTIVES: Diagnosis validation is a key aspect of the recruitment process in patient- and caregiver-reported studies where recruitment is not based at a clinical site; it ensures participants are eligible to take part in studies based on a diagnosis of the target disease. One source of diagnosis validation is requesting that prospective participants provide a diagnosis letter or proof of medication packaging during study enrollment.

The objective of this project was to explore people’s perceptions of a digital diagnosis validation feature.

METHODS: Individuals with various chronic medical conditions completed a web-based survey comprising questions on demographics, medical diagnosis, and their perceptions of using a digital diagnosis validation feature as part of enrollment in a research study.

RESULTS: Twenty-two individuals (mean age: 52, range: 28–74) completed the survey. Half of respondents (n=11) reported that they could obtain proof of their medical diagnosis easily; 36% (n=8) stated that it would be with difficulty, with the main reason reported being poor cooperation from healthcare facilities in obtaining this information.

Of those reporting that they could obtain proof easily, the majority (n=7, 64%) already had proof of diagnosis; of those reporting that they would have difficulty obtaining proof, the majority (n=6, 75%) did not currently have it.

Eighty-six percent of respondents (n=19) stated they would obtain proof from their surgery or specialist. The majority of respondents (86%) reported that they would be comfortable sharing a copy of their medical diagnosis as part of registration to a research study. Fifty-nine percent of respondents (n=13) reported that they would find it easy to use the document-upload feature.

CONCLUSIONS: The attitudes towards sharing medical information for study eligibility proof were generally positive. Employing such features can result in a reliable alternative to clinical site-based recruitment for patient- and caregiver-reported real-world studies.