Final Research Plan: Screening for Dyslipidemia and Use of Statins to Improve Cardiovascular Outcomes in Adults

Agency for Healthcare Research and Quality (AHRQ) sent this bulletin at 05/01/2014 12:05 PM EDT

The U.S. Preventive Services Task Force posted today a final Research Plan on screening for dyslipidemia and the use of statins to improve cardiovascular outcomes in adults. The draft Research Plan for this topic was posted for public comment from February 27 to March 26, 2014. The Task Force reviewed all of the comments that were submitted and took them into consideration as it finalized the Research Plan. To view the final Research Plan, please go tohttp://www.uspreventiveservicestaskforce.org/uspstf14/dyslipidadult/dyslipidadultfinalresplan.htm.

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Final Research Plan

Screening for Dyslipidemia and Use of Statins to Improve Cardiovascular Outcomes in Adults

The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from February 27 until March 26, 2014 at 5:00 p.m., ET. To view the draft Research Plan, click here.

I. Analytic Framework

Screening for Dyslipidemia to Improve Cardiovascular Outcomes

Select Text Description below for details.

[D] Select for Text Description.

Use of Statins to Improve Cardiovascular Outcomes

Abbreviations: CVD = cardiovascular disease; CHD = coronary heart disease; CVA = cerebrovascular accident; KQ = key question.

[D] Select for Text Description.

II. Key Questions to Be Systematically Reviewed

Screening for Dyslipidemia to Improve Cardiovascular Outcomes

What are the benefits of screening for dyslipidemia in asymptomatic adults ages 21 to 39 years on coronary heart disease (CHD)- or cerebrovascular accident (CVA)-related morbidity or mortality or all-cause mortality?
What are the harms of screening for dyslipidemia in asymptomatic adults ages 21 to 39 years?
What is the diagnostic yield of alternative screening strategies (e.g., universal vs. risk-based screening) for dyslipidemia in asymptomatic adults ages 21 to 39 years?
What are the benefits of treatment (e.g., drug or lifestyle interventions) in adults ages 21 to 39 years on CHD- or CVA-related morbidity or mortality or all-cause mortality?
What are the benefits of delayed versus immediate treatment in adults ages 21 to 39 years with dyslipidemia on CHD- or CVA-related morbidity or mortality or all-cause mortality?
What are the harms of drug treatment for dyslipidemia in asymptomatic adults ages 21 to 39 years?

Use of Statins to Improve Cardiovascular Outcomes

a. What are the benefits of treatment with statins in reducing the incidence of CHD- or CVA-related morbidity or mortality or all-cause mortality in asymptomatic adults age 40 years or older without prior cardiovascular disease (CVD) events?
b. What are the benefits of treatment with statins that target low-density lipoprotein (LDL) cholesterol versus other treatment strategies in adults age 40 years or older without prior CVD events?
c. Do the benefits of treatment with statins in adults age 40 years or older without prior CVD events vary by subgroups defined by demographic (e.g., age, sex, race) or clinical characteristics (e.g., specific cardiovascular risk factors, patients with familial hyperlipidemia, or 10-year or lifetime cardiovascular risk)?
What are the harms of treatment with statins in adults age 40 years or older without prior CVD events?
How do benefits and harms vary according to potency of statin treatment?

III. Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

Screening for Dyslipidemia to Improve Cardiovascular Outcomes

What are the benefits of drug treatment in adults ages 21 to 39 years on intermediate outcomes (e.g., lipid levels or atherosclerosis)?
How do lipid levels change over time in adults ages 21 to 39 years?

Use of Statins to Improve Cardiovascular Outcomes

What is the comparative accuracy of different cardiovascular risk assessment methods?
How do lipid levels change over time in adults age 40 years or older?

IV. Research Approach

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Report. Criteria are overarching as well specific to each of the KQs.

	Include	Exclude
Screening for Dyslipidemia to Improve Cardiovascular Outcomes
Population	Asymptomatic adults ages 21 to 39 years	Adults with known dyslipidemia (primary or secondary) or prior CVD events
Diseases	Dyslipidemia (as defined according to clinical practice guidelines, levels above the 90th percentile for lipid components positively associated with CHD risk, or other specified criteria)	Lipid levels not meeting thresholds for dyslipidemia
Screening interventions	Lipid panel (fasting or nonfasting lipid measurement: total or LDL cholesterol alone or in combination with HDL cholesterol, with or without measurement of other lipid markers)	Screening with family history only Genetic screening only
Screening comparator	No screening or usual care delivered in a universal or selective screening strategy	Other comparators not listed as included
Treatment interventions	Drug (e.g., statins) and lifestyle interventions (e.g., exercise and diet changes)	Other types of treatments not listed as included
Treatment comparator	No treatment or usual care	Other comparators not listed
Outcomes	KQs 1, 4, 5: CHD- and/or CVA-related morbidity or mortality; all-cause mortality KQ 2: Harms associated with the screening process (e.g., false-positives, false-negatives, psychosocial consequences such as anxiety, overdiagnosis, and others as identified in the literature) KQ 3: Diagnostic yield (true positives/number screened) KQ 6: Harms associated with drug treatment (e.g., myopathy, rhabdomyolysis, myalgia, cognitive loss, diabetes, elevations in liver function tests or creatine phosphokinase levels, and others as identified in the literature)	KQs 1, 4, 5: Outcomes not listed as included KQ 2: Adverse outcomes not associated with screening KQ 3: Outcomes not listed as included KQ 6: Other adverse outcomes not associated with drug treatment
Study design	RCTs, CCTs, cohort studies, high-quality systematic reviews	Other study designs
Settings	Publication date of 2008 to present; studies included in prior USPSTF reports Conducted in countries with a Human Development Index >0.9 (as defined by the United Nations) Primary care or primary care–relevant	Settings not generalizable to primary care; studies outside the stated timeframe
Use of Statins to Improve Cardiovascular Outcomes
Population	Asymptomatic adults (age ≥40 years) without prior CVD events (e.g., myocardial infarction, angina, revascularization, CVA, or transient ischemic attack), including persons who are at increased risk for CVD events based on 10-year or lifetime individualized CVD risk level or presence of specific CVD risk factors	Populations in other age groups or with a prior CVD-related event
Interventions	Statins	Other drugs or nondrug interventions (e.g., diet and exercise)
Comparators	KQ 1: No treatment or usual care without statin KQ 2: Placebo KQ 3: Higher vs. lower-potency statin therapy
Outcomes	KQs 1 and 3: CHD- and/or CVA-related morbidity or mortality; all-cause mortality KQs 2 and 3: Side effects from drug interventions, such as myopathy, rhabdomyolysis, myalgia, cognitive loss, diabetes, and elevations in liver function tests or creatine phosphokinase levels	KQ 1: Intermediate outcomes (e.g., lipid levels or measures of atherosclerosis, such as intima media thickness) KQ 2: Adverse events not related to statin use
Settings	Primary care or primary care–generalizable	Settings not generalizable to primary care
Study designs	RCTs, CCTs, and controlled cohort studies without publication date limitations; systematic reviews published in or after 2008	Other study designs (e.g., case-control, case series)

Abbreviations: CCT = controlled clinical trial; HDL = high-density lipoprotein; RCT = randomized, controlled trial.

V. Response to Public Comments

The draft research plan for this topic was posted for public comment from February 27 through March 26, 2014. In response to public comments, a key question on how benefits and harms vary according to statin therapy potency was added to the framework on the use of statins. Several key questions were revised to be clearer about the included demographic factors and to indicate explicitly that lifetime cardiovascular risk will also be considered as a potential factor to determine who benefits from therapy. The inclusion and exclusion criteria for the review were revised to include more potential definitions for dyslipidemia and alternative lipid markers for screening.

AHRQ Publication No. 14-05206-EF-5
Current as of May 2014

Internet Citation:

U.S. Preventive Services Task Force. Screening for Dyslipidemia and Use of Statins to Improve Cardiovascular Outcomes in Adults: Final Research Plan. AHRQ Publication No. 14-05206-EF-5. http://www.uspreventiveservicestaskforce.org/finalresplan2.htm