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Draft Research Plan

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


Note: This is a draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF.

The final Research Plan will be 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.

This draft Research Plan is available for comment from February 27 until March 26, 2014 at 5:00 p.m., ET. You may wish to read the entire Research Plan before you comment.


I. Proposed 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

Select Text Description below for details.

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

[D] Select for Text Description.

II. Proposed Key Questions to Be Systematically Reviewed

Screening for Dyslipidemia to Improve Cardiovascular Outcomes

  1. 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?
  2. What are the harms of screening for dyslipidemia in asymptomatic adults ages 21 to 39 years?
  3. 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?
  4. 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?
  5. 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?
  6. What are the harms of drug treatment for dyslipidemia in asymptomatic adults ages 21 to 39 years?

Use of Statins to Improve Cardiovascular Outcomes

  1. 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 or clinical characteristics (e.g., specific  cardiovascular risk factors, patients with familial hyperlipidemia, or 10-year cardiovascular risk)?
  2. What are the harms of treatment with statins in adults age 40 years or older without prior CVD events?

III. Proposed Contextual Questions

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

Screening for Dyslipidemia to Improve Cardiovascular Outcomes

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

Use of Statins to Improve Cardiovascular Outcomes

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

IV. Proposed Research Approach

The Proposed 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 (using thresholds from the National Cholesterol Education Program):
  • LDL cholesterol ≥130 mg/dL ±
  • NonHDL cholesterol ≥145 mg/dL ±
  • HDL cholesterol <40 mg/dL ±
  • Triglycerides ≥130 mg/dL (age ≥10 years)
Lipid levels not meeting inclusion thresholds
Screening interventions Lipid panel (fasting or nonfasting lipid measurement: total or LDL cholesterol alone or in combination with HDL cholesterol)
  • Screening with family history only
  • Genetic screening only
  • Other measures of lipids
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, 3, 4, 5: Outcomes not listed as included

KQ 2: Adverse outcomes not associated with screening

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 KQ 1: 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 individualized CVD risk level or presence of specific CVD risk factors

KQ 2: Asymptomatic adults without prior CVD events who are at increased risk for CVD events

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

 
Outcomes KQ 1: CHD- and/or CVA-related morbidity or mortality; all-cause mortality

KQ 2: 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.

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


Internet Citation:

U.S. Preventive Services Task Force. Screening for Dyslipidemia and Use of Statins to Improve Cardiovascular Outcomes in Adults: Draft Research Plan. AHRQ Publication No. 14-05206-EF-5. http://www.uspreventiveservicestaskforce.org/draftresplan2.htm



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