A technology-assisted approach to consumer self-selection for statin therapy showed substantial agreement with clinician selection, according to research results published in the Journal of the American College of Cardiology.
Barriers to statin use, according to study authors, include the reluctance of patients to seek regular medical care and a lack of access to health care resources, leading some to believe they should be made available without a prescription for appropriate patients. In this study, researchers compared concordance between participant and clinician assessment of statin therapy eligibility via a technology-assisted approach.
Participants were recruited through digital advertising, traditional media, and other communication methods. The advertisements invited people who were interested in cholesterol and heart health to phone a call center to assess whether they were eligible to participate in the study. Those enrolled completed an online self-assessment questionnaire, followed by a visit at a site center.
The primary study endpoint was the percentage of participants whose technology-assisted self-assessment came to the same conclusion as a clinician’s technology-assisted assessment for treatment with rosuvastatin, a synthetic statin developed by AstraZeneca, which funded the study. The secondary endpoint evaluated the percentage of participants with correct entries for self-selection questions and to determine the potential for errors.
A total of 1563 participants were assessed for eligibility. Of these, 1063 received an online health assessment link. Five hundred participants were defined as “completers” — those with both a participant and a clinician technology assisted health assessment. The mean age of patient participants was 59.2±12.7 years; 62.2% were female; 61% were White; 33.2% were Black, and 44.8% completed college or technical school.
Mean LDL-C was 106 mg/dL, while mean systolic BP was 127 mm Hg; participants with “limited literacy” (defined as those with a seventh- or eight-grade education level) had similar, although slightly lower, values. Lipid data and blood pressure documentation were provided by 73.3% and 32.6% of participants, respectively.
Concordance between consumer self-selection and clinician assessment was observed in 96.2% of participants (95% CI, 94.1%-97.7%); 4.6% were deemed appropriate for nonprescription statin treatment while 91.6% were deemed inappropriate. A concordant outcome without mitigation was observed in 96% of participants. Among those with limited literacy (n=83), 96.4% of participants achieved a concordant outcome.
More than 90% of outcomes for clinicians and participants deemed statins as “not right for you.” The most common non-qualifying reasons included the use of cholesterol or triglyceride-lowering medications, a low cardiovascular risk score, or low-risk demographic characteristics. Three of 26 “ok to use” results were changed to “not right for you” after clinician assessment. Discordant rejections stemmed from errors like laboratory input mistakes or laboratory data above the acceptable variability limits.
A total of 108 participant responses did not agree with clinician assessment. Thirteen errors were corrected; 12 were due to an age difference due to a birthday between completion of the questionnaire and the clinician assessment, and 1 answer of “yes” to a health assessment question regarding cardiac catheterization procedures.
Study limitations include a broad population that included few patients who were eligible for nonprescription statin treatment. Researchers said that, while the study helped determine whether ineligible consumers can be successfully excluded from treatment, “it did not provide a robust assessment of technology assisted self-selection in identifying patients most likely to benefit from nonprescription statin therapy.”
Still, the researchers considered the study a win for technology assisted self-selection of a nonprescription drug. “A novel approach…was successful in overcoming a significant barrier to the development of a nonprescription statin by ensuring that a high percentage of ineligible consumers were denied access and that only those with an appropriate level of risk were deemed eligible to access this medication.”
Disclosure: This study was funded by AstraZeneca. Please see the original reference for a full list of authors’ disclosures.
Nissen SE, Hutchinson HG, Wang TY, et al. Technology-assisted self-selection of candidates for nonprescription statin therapy. J Am Coll Cardiol. 2021;78(11):1114-1123. doi: 10.1016/j.jacc.2021.06.048