Statin Use for the Primary Prevention of CVD in Adults: Clinician-Facing CDS Intervention

Description

Presents a United States 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.

Creation Date
Version
0.2
Unique Identifier
CDS 009
Status
Experimental
False

Artifact Creation and Usage

Contributors

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

IP Attestation The author asserts that this artifact has been developed in compliance with the intellectual property rights attributed to the source material.
Copyrights

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

Implementation Details
Engineering Details

This CDS logic is expressed using Clinical Quality Language (CQL) and the FHIR Draft Standard for Trial Use 2 (DSTU2) 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-clinical-quality-language
     FHIR DSTU2: https://www.hl7.org/fhir/DSTU2/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, which provides two APIs for interacting with CQL as a service:

  1. CQL Execution Service (CQL ES)
  2. 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 a prototype implementation of a RESTful API conforming to the proposed CDS Hooks standard.  CDS Hooks is still evolving and currently undergoing HL7 ballot review for version 1.0.0.  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.

Repository Information
Approval Date
Publication Date
Last Review Date
Knowledge Level

Structured code that is interpretable by a computer (includes data elements, value sets, logic)

Purpose and Usage
Purpose

Presents statin therapy recommendations to facilitate primary prevention of CVD events and mortality

Intended Population

This artifact is intended for use in a broad population aged 40 and older without a history of CVD who do not have current signs and symptoms of CVD (i.e. symptomatic coronary artery disease or ischemic stroke).

Usage

Intended for use by providers delivering care in an outpatient setting

Cautions

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. Source: Statin Use for Primary Prevention of CVD and CRC

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 CVD risk score is >=10% [Grade B], Discuss low-moderate intensity statin if CVD 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, as opposed to both.

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 published on the Repository. The only difference between the two is that this artifact generates CDS intervention text geared towards a prescribing clinician, whereas the other artifact generates intervention text appropriate for a patient. Please use caution when downloading the logic to ensure that you selected the right version for your use.
Evidence-base may be in the process of being updated: On September 12, 2019, this recommendation was in "Step 2" of being updated by the USPSTF (i.e., USPSTF members are reviewing the evidence and developing a draft recommendation). However, on February 17, 2020, this recommendation was no longer on the update list. The updated recommendation will ultimately have to move through "Step 3" of the update process (i.e., finalizing the Recommendation Statement) if it remains in the update process before it is released to the public.
Interested parties can visit the "Recommendations in Progress" page on the USPSTF website to learn more about the stages of USPSTF recommendation development (https://www.uspreventiveservicestaskforce.org/Page/Name/topics-in-progress) and monitor updates to the Statin Use for the Primary Prevention of CVD in Adults recommendation.
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.
Supporting Evidence
Source Description

Derived from USPSTF Statin Use for the Primary Prevention of CVD in Adults Recommendation

References

United States Preventive Services Task Force. 2016. Statin Use for the Primary Prevention of CVD in Adults. Journal of the American Medical Association. November 16, 2016. Volume 316, Number 19. Accessed on April 10, 2016 at: http://jamanetwork.com/journals/jama/fullarticle/2584058.

Recommendation

The USPSTF recommends that adults without a history of cardiovascular disease (CVD) (ie, symptomatic coronary artery disease or ischemic stroke) use a low- to moderate-dose statin for the prevention of CVD events and mortality when all of the following criteria are met: 1) they are aged 40 to 75 years; 2) they have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking); and 3) they have a calculated 10-year risk of a cardiovascular event of 10% or greater. Source: Statin Use for the Primary Prevention of CVD in Adults

Strength of Recommendation

Grade B

Quality of Evidence

See full recommendation report

Recommendation

Although statin use may be beneficial for the primary prevention of CVD events in some adults with a 10-year CVD event risk of less than 10%, the likelihood of benefit is smaller, because of a lower probability of disease and uncertainty in individual risk prediction. Clinicians may choose to offer a low- to moderate-dose statin to certain adults without a history of CVD when all of the following criteria are met: 1) they are aged 40 to 75 years; 2) they have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking); and 3) they have a calculated 10-year risk of a cardiovascular event of 7.5% to 10%. Source: Statin Use for the Primary Prevention of CVD in Adults

Strength of Recommendation

Grade C

Quality of Evidence

See full recommendation report

Artifact Decision Notes

Decision notes are outlined in the attached implementation guide.

Artifact Representation
Triggers

Trigger Type: Named event

Trigger Event: Provider opens an outpatient encounter

Inclusions
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 CVD risk score >=7.5% (MOST RECENT value within the past 6 years)
Exclusions
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)
Interventions and Actions
Intervention

DISPLAY notification to provider:


1) If CVD risk score >=7.5% and <10% (Grade C):
Recommendation: Discuss initiation of low to moderate intensity lipid lowering therapy
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 calculated 10-year CVD event risk of 7.5% to 10%.


2) If CVD risk score >=10% (Grade B):
Recommendation: Start low to moderate intensity lipid lowering therapy 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 calculated 10-year CVD event risk of 10% or greater.


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 calculated 10-year CVD event risk >= 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 CVD 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 CVD risk score.

Action REQUEST medication order
Action DOCUMENT any new medications on the active medication list
Action DOCUMENT provider response if a reason for not prescribing a statin is provided
Intervention

DISPLAY link to relevant recommendation statement available at: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/statin-use-in-adults-preventive-medication1?ds=1&s=statin

Intervention DISPLAY link to reference information: http://jamanetwork.com/journals/jama/fullarticle/2584058
Intervention

DISPLAY link to statin shared decision making tool (e.g. Mayo Clinic Shared Decision Making National Resource Center at: https://statindecisionaid.mayoclinic.org/)

Intervention DISPLAY link to education materials that are relevant to the patient's plan of care
Testing Experience
Pilot Experience

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 attached documents in the Implementation Detail section of the repository to view the Pilot Report and the list of enhancements made to the artifact based on the pilot implementation.