Scoping Review of the Literature
We identified published studies that described systematic collection of data from patients or clinicians regarding test result communication through patient portals. With assistance from a medical librarian, we developed a search strategy covering four research databases (Embase, Medline, Web of Science, and CINAHL) to find literature pertaining to diagnostic test results and electronic portal access (see search strategy, Appendix A).
Included publications had to:
- Be written in English.
- Be published after enactment of the Cures Act (beginning 1/1/2017 through 12/31/2023).
- Report quantitative or qualitative data.
- Describe patients or providers’ behaviors, attitudes, or experiences related to accessing test results through a portal.
Conference abstracts and review articles were included if they reported original data. Exclusion criteria included editorials and articles that addressed direct-to-consumer testing and pharmacogenetic testing. We excluded studies of patient portal use if they did not include data specific to test result access.
We used Covidence (Veritas Health Innovation, Melbourne, Australia) to screen and select articles and to perform data charting. We charted data using a form that we created and tested before use to ensure usability and adequate coverage of the literature. Screening, full-text review, and data charting were all performed dually by two authors, and discrepancies were resolved by the first author after discussion among the team.
For all included records, we extracted study characteristics, including the country of origin, setting, sample size, main aims, data sources, and mode of data collection. Although we did not perform a formal quality assessment, we recorded the study design as a marker of study rigor. For each study, we also extracted evidence, as applicable, about:
- The absolute or relative frequency of patient portal use for test result access.
- Patient characteristics associated with accessing test results through portals.
- Patient experiences and reactions toward test results provided through a portal.
- Attitudes and experiences of physicians and other clinicians related to patient access to test results via portal.
We summarized data both thematically and using counts and percentages.
Subject Matter Expert Interviews
We conducted qualitative interviews to understand SMEs’ experiences with implementing the rules of the 21st Century Cures Act and possible recommendations for other organizations. We developed a semistructured interview guide to provide a consistent approach to interviews. Questions focused on the information blocking rule and its implications for release of test results to patients through patient portals. The interview guide focused on organizational response to implementation of the Cures Act, patient experience, and implications of the Cures Act for clinical practice.
Between March and April 2023, the first author conducted 9 semistructured interviews that included 11 participants (2 interviews included 2 participants). Through purposive sampling, participants were invited from two broad groups.
The first group was composed of health information technology/informatics experts who work in public and private healthcare organizations or academic institutions (n = 7). All but two of these experts were physicians (the 2 nonclinicians were clinical informatics researchers), and their job titles included medical informaticist, program director, chief medical information officer, information technology services medical director, and professor of biomedical informatics.
The second group (n = 4) consisted of employees of federal agencies (National Institutes of Health, Centers for Disease Control and Prevention, and Veterans Health Administration) that have a mission relevant to healthcare or implementation of health policy.
Each interview lasted approximately 30 minutes. Participants consented to audio recording. Interviews were transcribed using speech-to-text recognition software and subsequently de-identified to maintain confidentiality of all participants.
A qualitative methodologist conducted a rapid content analysis of interview transcripts, identifying codes and categories within the data and integrating these to identify broader themes. Initial data analysis was performed by repeatedly reading transcripts. Codes were derived by highlighting words from the transcripts that seemed to capture the key idea or concept and a codebook was developed. Each transcript was analyzed in a similar manner until no more meaningful concepts emerged. The first author then reviewed the resulting codes and categories.
