JMIR Publications

ABSTRACT

Background:

There is substantial prior research on patient perspectives relating to the use of health information for research. Numerous communication barriers challenge transparency between researchers and data subjects in secondary database research (e.g., waived informed consent, knowledge gaps). Individual concerns and misconceptions challenge trust in researchers despite efforts to protect data. Technical software used to protect research data can further complicate public understanding of research. For example, MiNDFIRL (MInimum Necessary Disclosure For Interactive Record Linkage) is a prototype software that can be used to enhance confidentiality of datasets by restricting disclosures of identifying information during the record linkage process. However, researchers communicating how a software like MINDFIRL is used to protect data must overcome the previously mentioned communication barriers. One proposed solution is the creation of an interactive web-based Frequently Asked Question (FAQ) template that can be adapted and used to communicate research issues to data subjects.

Objective:

This study aims to improve communications with patients about how complex software, such as MiNDFIRL, is used to enhance privacy in secondary database studies to maintain public trust in researchers.

Methods:

A three-round Delphi was used to develop the FAQ document to communicate privacy issues relating to a generic secondary database study using the MiNDFIRL software. The Delphi panel consisted of 39 patients with chronic health conditions. We revised the FAQ between Delphi rounds and provided participants with summary feedback. We adopted a conservative consensus threshold of <10% negative feedback per FAQ section.

Results:

We developed consensus language for 21 of 24 FAQ sections. Participant feedback demonstrated preference differences (e.g., brevity versus comprehensiveness). We adapted the final FAQ into an interactive web-based format that 93.9% of participants found helpful or very helpful. The template FAQ and MiNDFIRL source code are available on Github. Results indicate several patient communication considerations, including 1) patients have diverse and varied preferences; 2) overreliance on readability scores can be problematic; 3) tone is important but challenging; and 4) patients want information on security, identifiers, and final disposition of information.

Conclusions:

The findings provide insights on what research-related information is useful to patients and how researchers can communicate it. These findings align with the current understanding of health literacy and its challenges. Communication is essential to transparency, and ethical data use, yet it is exceedingly challenging. Developing FAQ template language to accompany complex software may enable researchers to provide greater transparency when informed consent is not possible. Clinical Trial: N/A