Online self-assessment to test eligibility for nonprescription statin therapy
A study compared the concordance between participant and clinician assessment of eligibility for rosuvastatin 5 mg using an at-home web-based application.
Technology-Assisted Self-Selection of Candidates for Nonprescription Statin TherapyLiterature - Nissen SE, Hutchinson HG, Wang TY et al. - J Am Coll Cardiol. 2021 Sep 14;78(11):1114-1123. doi: 10.1016/j.jacc.2021.06.048.
Introduction and methods
Background
A large proportion of patients eligible for statin therapy remain untreated [1,2]. Prior efforts to achieve regulatory approval of nonprescription statins were unsuccessful as they were unable to demonstrate that only eligible consumers would receive appropriate treatment [3-7].
Aim of the study
This study compared the concordance between participant and clinician assessment of eligibility for rosuvastatin 5 mg using an at-home web-based application.
Online self-assessment
Participants used the web-based application to respond to questions related to medical history, medication use, total cholesterol (TC), HDL-c, LDL-c, triglycerides (TG), blood pressure, and if needed, waist circumference, hsCRP and coronary artery calcium (CAC) score. Eligibility for treatment with rosuvastatin 5 mg was assessed by the web application using the ACC/AHA 2018 Cholesterol Treatment Guidelines and a proposed drug facts label for nonprescription rosuvastatin [8]. The application released 1 of 3 possible self-selection outcomes: “OK to use”, “not right for you” or “ask a doctor”.
Clinician assessment
After completion of the online self-assessment, participants visited a research site and were instructed to bring verification documents of the laboratory values and BP (not older than 12 months). This information was provided to a telemedicine clinician who conducted an independent medical evaluation using the same web application used by the participant.A total of 500 participants completed the study of whom 83 had limited literacy.
Outcomes
The primary outcome was the proportion of participants whose technology-assisted self-assessment outcome was identical to the clinician’s technology-assisted assessment.
The secondary outcome was the percentage of participants with correct entries for all self-selection questions.
Main results
primary outcome
- 96.2% of participants (n=481 of 500) had an self-assessment outcome that was identical to the clinician’s assessment (95% CI 94.1%-97.7%).
- 4.6% (n=23) of participants were deemed eligible for nonpresciption rosuvastatin 5 mg and 91.6% (n=458) were deemed ineligible. Reasons for not qualifying for rosuvastatin 5 mg included use of cholesterol- or TG-loweing medications, low CV risk score or low-risk demographic characteristics.
- Among participants with limited literacy, 96.4% of participants (n=80 of 83) had an concordant outcome (95% CI 89.8%-99.2%).
Details of discordant cases
- In 19 participants, the self-assessment outcome was discordant with the clinician’s assessment. 3 participants received an incorrect “OK to use”, 14 participants an incorrect “not right for you” and 2 participants an incorrect “ask a doctor” outcome.
- Among the participants who received an incorrect “OK to use” outcome, two were deemed ineligible due to an incorrect self-evaluation answer of family history. One participant entered data yielding an estimated 10-year risk of 15%, while the clinician’s entry resulted in an estimated 10-year risk of 24%, which requires a higher statin dose.
- Among participants who received an incorrect “not right for you” outcome, common mistakes in the self-assessment included laboratory input mistakes, incorrectly identifying as taking a statin or incorrect input of family history.
Secondary outcome
- 81.0% of participants (n=405 of 500) answered all self-selection questions correctly (i.e. in concordance with the clinician’s entry).
Conclusion
Self-assessment using an web application to test eligibility for statin therapy achieved high concordance with the clinician’s assessment: The self-assessment outcome was identical to the clinician’s technology-assisted assessment in >95% of cases.
References
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2. Bradley CK, Wang TY, Li S, et al. Patient-reported reasons for declining or discontinuing statin therapy: insights from the PALM registry. J Am Heart Assoc. 2019;8:e011765.
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6. Food and Drug Administration, Merck Research Labs. Joint meeting of the Nonprescription Drugs Advisory Committee and Endocrinological and Metabolic Drugs Advisory Committee, Mevacor® NDA 21-213, lovastatin. 2000; 2000. Accessed July 30, 2021. https://wayback.archive-it.org/7993/20170404111228/https://www.fda.gov/ohrms/dockets/ac/00/slides/3622s1.htm
7. Actual Use Trial of Atorvastatin Calcium 10 mg. A multicenter, actual use trial in a simulated over-the-counter environment of atorvastatin calcium 10 mg. ClinicalTrials.gov identifier: NCT01964326. Accessed July 30, 2021. https://clinicaltrials.gov/ct2/show/NCT01964326
8. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report on the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73:3168–3209.