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This artifact presents a U.S. Preventive Services Task Force (USPSTF) statin therapy recommendation for adults aged 40 to 75 years without a history of cardiovascular disease (CVD) who have 1 or more CVD risk factors (i.e., dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk score of 7.5% or greater. The recommendations vary based on the level of the risk score.
Artifact Creation and Usage
This artifact was developed by MITRE software engineers and clinical informaticists, in collaboration with clinical subject matter experts and leaders from the USPSTF.
Additional information about MITRE's health expertise is available here.
Additional information about the USPSTF's preventive health expertise is available here.
Recommendation is copyrighted by USPSTF and administered by AHRQ.
If you would like further information, would like to give us feedback, or have any questions about this artifact, please contact us at ClinicalDecisionSupport@ahrq.hhs.gov
| This CDS logic is expressed using Health Level Seven International (HL7) Clinical Quality Language (CQL) and the HL7 Fast Healthcare Interoperability Resources (FHIR) data model. All value sets referenced in the logic are published on the Value Set Authority Center (VSAC). In addition, a FHIR Clinical Reasoning representation has been provided to demonstrate how the CDS logic can be contextualized using FHIR PlanDefinition and Library resources. Additional details about these resources can be accessed via the following URLs: CQL: https://ecqi.healthit.gov/cql FHIR DSTU2: https://www.hl7.org/fhir/DSTU2/index.html FHIR R4: https://hl7.org/fhir/R4/index.html VSAC: https://vsac.nlm.nih.gov/ FHIR Clinical Reasoning: http://hl7.org/fhir/R4/clinicalreasoning-module.html |
In September 2018, The MITRE Corporation developed a CQL Services application. CQL Services 2.0.1 is the most recent version at time of artifact review. The application provides two APIs for interacting with CQL as a service:
- CQL Execution Service (CQL ES)
- CQL Hooks API
The CQL Execution Service, also known as the “shim”, was developed to support the pilot of the “Statin Use for the Primary Prevention of CVD in Adults” CDS artifact. This prototype software allows CQL execution to be externalized via a RESTful web service that accepts requests for CQL execution and responds with the calculated results. CQL ES supports simple registration of CQL artifacts by placing CQL ELM files in a predetermined file location on the server. In this way, artifact updates can be easily applied by simply overwriting older CQL ELM files with updated versions.
The CQL Hooks API provides an implementation of a RESTful API conforming to the proposed CDS Hooks standard. The CQL Hooks implementation provides a mechanism to allow CQL to be exposed as a CDS Hooks service via a configuration file that maps CDS Hooks concepts to CQL libraries. Like the CQL Execution Service, CQL ELM files can be easily added and modified via a predetermined file location on the server.
CQL Services’ implementation on Node.js allows for flexible deployment options, supporting Windows, Mac, and Linux environments. For the pilot, the execution service was deployed on a Windows 2012 Server platform using PM2 as a service-wrapper.
Additional details regarding installation and configuration can be found in the README.md file and supplemental documentation included in the CQL Services open source software code available at: https://github.com/AHRQ-CDS/AHRQ-CDS-Connect-CQL-SERVICES.
Structured code that is interpretable by a computer (includes data elements, value sets, logic)
Presents statin therapy recommendations to a clinician to facilitate primary prevention of CVD events and mortality
This artifact is intended for use in adults aged 40-75 without a history or current signs and symptoms of CVD (i.e. symptomatic coronary artery disease or ischemic stroke).
Intended for use by providers delivering care in an outpatient setting
Note: This USPSTF recommendation does not apply to adults with a low-density lipoprotein cholesterol (LDL-C) level greater than 190 mg/dL (to convert LDL-C values to mmol/L, multiply by 0.0259) or known familial hypercholesterolemia; these persons are considered to have very high cholesterol levels and may require statin use.
Grade B and Grade C distinction: The expression logic within this artifact supports both the Grade B and Grade C USPSTF recommendations. CQL code designates the appropriate statin recommendation based on the patient's risk score (i.e. Start low-moderate intensity statin if 10-year ASCVD risk score is >=10% [Grade B], Discuss low-moderate intensity statin if 10-year ASCVD risk score is >=7.5% AND <10% [Grade C]). Implementers can delete a sub-section of the CQL code if they chose to support only one of the two recommendations.
| The CDS Connect Repository hosts another artifact derived from the same evidence base: This artifact shares the same inclusion and exclusion logic as the Statin Use for Primary Prevention of CVD in Adults: Patient-Facing CDS Intervention artifact also published on the Repository. The two artifacts differ in that: 1) this artifact generates CDS intervention text geared toward a prescribing clinician, whereas the other artifact generates intervention text appropriate for a patient, and 2) clinicians receive both Grade B and Grade C recommendations while patients receive only Grade B recommendations. Please use caution when downloading the logic to ensure that you selected the right version for your use. |
| New Evidence was published by the USPSTF in August, 2022 and was "generally consistent" with the 2016 recommendation. |
| Pregnancy guidance: This artifact follows the 2022 USPSTF guideline which includes pregnancy as a contraindication for recommending statin therapy. In 2021 the FDA recommended statin manufacturers remove the contraindication to use in pregnant patients. Their reasoning is that recent literature shows that for pregnant patients at very high risk of heart attack or stroke (including those with familial hypercholesterolemia or existing CAD) the benefits outweigh the risks of continuing statins during pregnancy. |
| Updated ACC/AHA Guidelines: In January 2024 the ACC/AHA published an updated risk calculator. This guideline will eventually replace the pooled cohort equations (PCE) on which the USPSTF guideline is based. The new model, called PREVENT (Predicting Risk of cardiovascular disease EVENTs), adds chronic kidney disease (CKD), obesity, and diabetes to existing risk factors; adds heart failure as an outcome; and includes data beginning at age 30. It is anticipated that this calculation will be incorporated into EMRs when published and be added to professional society guidelines as they are updated. As a result, practitioners may have a different risk calculator embedded in their EMR in addition to the one in this artifact. |
| Additional information and resources: CDS Connect artifacts are not “standalone” and are not intended to be completely plug-and-play (i.e., healthcare systems will need to integrate each artifact with components of their health information technology (IT) system for the artifact to work). CQL Services, an open source publicly-available tool that facilitates integration of CQL code with a health IT system, was used during the pilot implementation of this artifact. CQL Services is available here: https://github.com/AHRQ-CDS/AHRQ-CDS-Connect-CQL-SERVICES. Implementers should conduct extensive testing, including clinical testing in real-life workflows, of all artifacts. It is expected that artifacts will be customized and adapted to local clinical and IT environments. |
This artifact is derived from the USPSTF Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication recommendation.
US Preventive Services Task Force. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2022;328(8):746–753. doi:10.1001/jama.2022.13044 https://jamanetwork.com/journals/jama/fullarticle/2795521
Chou R, Cantor A, Dana T, et al. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022;328(8):754–771. doi:10.1001/jama.2022.12138 https://jamanetwork.com/journals/jama/fullarticle/2795522
Recommendation #1:
The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (i.e. dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year risk of a cardiovascular event of 10% or greater.
Grade B
See full recommendation report
Recommendation #2:
The USPSTF recommends that clinicians selectively offer a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (i.e. dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year risk of a cardiovascular event of 7.5% to less than 10%. The likelihood of benefit is smaller in this group than in persons with a 10-year risk of 10% or greater.
Grade C
See full recommendation report
Decision notes are outlined in Appendix A in the attached implementation guide.
- Trigger Type: Named event
- Trigger Event: Provider opens an outpatient encounter
| Patient is >=40 and <=75 years of age |
| AND 1 or more risk factor: |
| LDL-C lab result > 130 mg/dL (MOST RECENT value within the past 6 years) |
| OR HDL-C < 40 mg/dL (MOST RECENT value within the past 6 years) |
| OR Diabetes (Type 1 or Type 2) |
| OR Hypertension |
| OR Smoking (MOST RECENT value within the past 6 years) |
| AND 10-year ASCVD risk score >=7.5% (MOST RECENT value within the past 6 years) |
| CVD |
| OR LDL-C lab result >190 mg/dL, MOST RECENT VALUE within the past 6 years (final, amended) |
| OR known Familial hypercholesterolemia (active) |
| OR Pregnancy (active) |
| OR Pregnancy observation within the past 42 weeks (final, amended) |
| OR Breastfeeding (active) |
| OR Breastfeeding observation, MOST RECENT within the past 1 year (final, amended) |
| OR ESRD (active) |
| OR ESRD encounter, within the past 1 month (in progress, finished) |
| OR Dialysis procedure, within the past 7 days (in progress, completed) |
| OR Dependence on dialysis (active, relapse) |
| OR Cirrhosis (active, relapse) |
| OR Rhabdomyolysis (active, relapse) |
| OR Statin medication order, within the past 2 years (active, completed) |
| OR Statin medication statement, within the past 2 years (active) |
| Intervention | |
| DISPLAY notification to provider: 1) If CVD risk score >=10% (Grade B): Recommendation: Prescribe a statin based on outcome of shared decision making between patient and provider Rationale: The USPSTF found adequate evidence that use of low- to moderate-dose statins reduces the probability of CVD events (MI or ischemic stroke) and mortality by at least a moderate amount in adults aged 40 to 75 years who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a 10-year ASCVD risk score of 10% or greater. 2) If CVD risk score >=7.5% and <10% (Grade C): Recommendation: Discuss initiation of a statin Rationale: The USPSTF found adequate evidence that use of low- to moderate-dose statins reduces the probability of CVD events and mortality by at least a small amount in adults aged 40 to 75 years who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a 10-year ASCVD risk score of 7.5% to 10%. 3) If Does Not Meet Inclusion Criteria: Recommendation: No USPSTF recommendation provided, as patient does not meet inclusion criteria Rationale: The USPSTF guideline applies to adults aged 40 to 75 years who have 1 or more CVD risk factors (dyslipidemia, as evidenced by LDL > 130 mg/dL or HDL < 40 mg/dL, diabetes, hypertension, or smoking) and a 10-year ASCVD risk score >= 7.5% (grade C) or >= 10% (grade B) 4) Is Excluded: Recommendation: No USPSTF recommendation provided, as patient meets exclusion criteria Rationale: This USPSTF guideline should not be used for patients with any of the following: LDL > 190 mg/dL, a previous CVD diagnosis or procedure, familial hypercholesterolemia, end stage renal disease, cirrhosis, recent dialysis, or patients who are pregnant, breastfeeding, or currently on a statin. 5) Error Message When Missing Data But CDS Can Still Be Processed Enough To Get An Answer WARNING: Adequate data to process CDS, but one of the following items is missing or more than 6 years old: LDL, HDL, smoking status, or 10-year ASCVD risk score. 6) Error Message When Missing Data Prevents CDS From Being Processed ERROR: Inadequate data to process CDS, as one of the following items is missing or more than 6 years old: LDL, HDL, smoking status, or 10-year ASCVD risk score. | |
| Actions | |
| REQUEST medication order | |
| DOCUMENT any new medications on the active medication list | |
| DOCUMENT provider response if a reason for not prescribing a statin is provided | |
| Interventions | |
| DISPLAY link to relevant recommendation statement available at: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/statin-use-in-adults-preventive-medication | |
| DISPLAY link to reference information: https://jamanetwork.com/journals/jama/fullarticle/2795521 | |
| DISPLAY link to statin shared decision making tool (e.g. Mayo Clinic Shared Decision Making National Resource Center at: https://statindecisionaid.mayoclinic.org/) | |
| DISPLAY link to education materials that are relevant to the patient's plan of care |
This artifact underwent integration testing and an 8-week pilot implementation at a Federally Qualified Health Center (FQHC) affiliated with AllianceChicago in July-August 2017. The artifact performed reliably and consistently produced appropriate notifications and interventions to clinical providers.
Please see the attached documents in the 'Implementation Details' section of this page under 'Technical Files' to view the Pilot Report and the list of enhancements made to the artifact based on the pilot implementation.