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2013-ahaacc-guideline-on-lifestyle-management-to-reduce-cardiovascular-risk-a-report-of-the-american-college-of-cardiologyamerican-heart-association-task-force-on-practice-guidelines
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<h1>2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.</h1>
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<table><tr><td>Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith SC Jr, Svetkey LP, Wadden TA, Yanovski SZ. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2960-84. [132 references] <a href="https://web.archive.org/web/20180712204842/http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=24239922" target="_blank">PubMed</a> <img alt="External Web Site Policy" src="/web/20180712204842im_/https://www.guideline.gov/UI/images/icon_externallink.gif"/></td></tr></table> <p><a href="/web/20180712204842/https://www.guideline.gov/Home/Disclaimer?id=48338&contentType=fulltextlink&redirect=http%253a%252f%252fcontent.onlinejacc.org%252farticle.aspx%253farticleID%253d1770218">View the original guideline documentation</a> <img alt="External Web Site Policy" src="/web/20180712204842im_/https://www.guideline.gov/UI/images/icon_externallink.gif"/></p>
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<p><div class="content_para"><p>This is the current release of the guideline.</p>
<p>This guideline meets NGC's 2013 (revised) inclusion criteria.</p></div></p>
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<div id="classification-tab" class="content-tab-panel">
<h4>Age Group</h4>
<ul>
<li><a href="/web/20180712204842/https://www.guideline.gov/search?f_Age_of_Target_Population=Adolescent%20%2813%20to%2018%20years%29&fLockTerm=Adolescent%2B%2813%2Bto%2B18%2Byears%29">Adolescent (13 to 18 years)</a></li>
<li><a href="/web/20180712204842/https://www.guideline.gov/search?f_Age_of_Target_Population=Adult%20%2819%20to%2044%20years%29&fLockTerm=Adult%2B%2819%2Bto%2B44%2Byears%29">Adult (19 to 44 years)</a></li>
<li><a href="/web/20180712204842/https://www.guideline.gov/search?f_Age_of_Target_Population=Aged%20%2865%20to%2079%20years%29&fLockTerm=Aged%2B%2865%2Bto%2B79%2Byears%29">Aged (65 to 79 years)</a></li>
<li><a href="/web/20180712204842/https://www.guideline.gov/search?f_Age_of_Target_Population=Aged%2C%2080%20and%20over&fLockTerm=Aged%252c%2B80%2Band%2Bover">Aged, 80 and over</a></li>
<li><a href="/web/20180712204842/https://www.guideline.gov/search?f_Age_of_Target_Population=Middle%20Age%20%2845%20to%2064%20years%29&fLockTerm=Middle%2BAge%2B%2845%2Bto%2B64%2Byears%29">Middle Age (45 to 64 years)</a></li>
</ul>
<h4>UMLS Concepts <a href="/web/20180712204842/https://www.guideline.gov/help-and-about/search-browse/umls-concepts" class="what-is">(what is this?)</a></h4>
<div class="field">
<h5 class="field-label">ICD9CM</h5>
<div class="field-content">
<a href="/web/20180712204842/https://www.guideline.gov/search?f_ICD9CM_CUI=C0007222&fLockTerm=Cardiovascular+disease%2c+unspecified">Cardiovascular disease, unspecified</a>
(429.2), <a href="/web/20180712204842/https://www.guideline.gov/search?f_ICD9CM_CUI=C0020538&fLockTerm=Complications+affecting+other+specified+body+systems%2c+not+elsewhere+classified%2c+hypertension">Complications affecting other specified body systems, not elsewhere classified, hypertension</a>
(997.91), <a href="/web/20180712204842/https://www.guideline.gov/search?f_ICD9CM_CUI=C0154251&fLockTerm=Unspecified+disorder+of+lipoid+metabolism">Unspecified disorder of lipoid metabolism</a>
(272.9) </div>
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</div>
<!-- /.field -->
<div class="field">
<h5 class="field-label">MSH</h5>
<div class="field-content">
<a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0007222&fLockTerm=Cardiovascular+Diseases">Cardiovascular Diseases</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0012159&fLockTerm=Diet+Therapy">Diet Therapy</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0242970&fLockTerm=Diet%2c+Fat-Restricted">Diet, Fat-Restricted</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0012169&fLockTerm=Diet%2c+Sodium-Restricted">Diet, Sodium-Restricted</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0015259&fLockTerm=Exercise">Exercise</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0020443&fLockTerm=Hypercholesterolemia">Hypercholesterolemia</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0020538&fLockTerm=Hypertension">Hypertension</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0023676&fLockTerm=Life+Style">Life Style</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0154251&fLockTerm=Lipid+Metabolism+Disorders">Lipid Metabolism Disorders</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0026606&fLockTerm=Motor+Activity">Motor Activity</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C2937349&fLockTerm=Nutrition+Therapy">Nutrition Therapy</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MSH_CUI=C0242550&fLockTerm=Risk+Reduction+Behavior">Risk Reduction Behavior</a>
</div>
<!-- /.field-content -->
</div>
<!-- /.field -->
<div class="field">
<h5 class="field-label">MTH</h5>
<div class="field-content">
<a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0007222&fLockTerm=Cardiovascular+Diseases">Cardiovascular Diseases</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0012159&fLockTerm=Diet+therapy">Diet therapy</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0015259&fLockTerm=Exercise">Exercise</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0242970&fLockTerm=Fat-Restricted+Diet">Fat-Restricted Diet</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0020443&fLockTerm=Hypercholesterolemia">Hypercholesterolemia</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0020538&fLockTerm=Hypertensive+disease">Hypertensive disease</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0023676&fLockTerm=Life+Style">Life Style</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0154251&fLockTerm=Lipid+Metabolism+Disorders">Lipid Metabolism Disorders</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0012169&fLockTerm=Low+sodium+diet">Low sodium diet</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C2937349&fLockTerm=Nutrition+Therapy">Nutrition Therapy</a>
, <a href="/web/20180712204842/https://www.guideline.gov/search?f_MTH_CUI=C0026606&fLockTerm=Physical+activity">Physical activity</a>
</div>
<!-- /.field-content -->
</div>
<!-- /.field -->
<div class="field">
<h5 class="field-label">SNOMEDCT_US</h5>
<div class="field-content">
<a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0001701&fLockTerm=Aerobic+exercises">Aerobic exercises</a>
(229072005), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C3661728&fLockTerm=Decreased+trans+fat+diet">Decreased trans fat diet</a>
(436961000124107), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0007222&fLockTerm=Disorder+of+cardiovascular+system">Disorder of cardiovascular system</a>
(49601007), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0154251&fLockTerm=Disorder+of+lipid+metabolism">Disorder of lipid metabolism</a>
(267431006), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0015259&fLockTerm=Exercise">Exercise</a>
(183301007), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0015259&fLockTerm=Exercise">Exercise</a>
(256235009), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0015259&fLockTerm=Exercise">Exercise</a>
(61686008), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0020443&fLockTerm=Hypercholesterolemia">Hypercholesterolemia</a>
(13644009), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0020538&fLockTerm=Hypertensive+disorder">Hypertensive disorder</a>
(38341003), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0023676&fLockTerm=Life+style">Life style</a>
(134436002), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0023676&fLockTerm=Life+style">Life style</a>
(60134006), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0242970&fLockTerm=Low+fat+diet">Low fat diet</a>
(16208003), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0242970&fLockTerm=Low+fat+diet">Low fat diet</a>
(436861000124104), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0452298&fLockTerm=Low+saturated+fat+diet">Low saturated fat diet</a>
(226111008), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0452298&fLockTerm=Low+saturated+fat+diet">Low saturated fat diet</a>
(436951000124105), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0012169&fLockTerm=Low+sodium+diet">Low sodium diet</a>
(386619000), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0012169&fLockTerm=Low+sodium+diet">Low sodium diet</a>
(437421000124105), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C2937349&fLockTerm=Nutrition+therapy">Nutrition therapy</a>
(386373004), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0026606&fLockTerm=Physical+activity">Physical activity</a>
(48761009), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C0026606&fLockTerm=Physical+activity">Physical activity</a>
(68130003), <a href="/web/20180712204842/https://www.guideline.gov/search?f_SNOMEDCT_US_CUI=C1319160&fLockTerm=Risk+control+behavior%3a+cardiovascular+health">Risk control behavior: cardiovascular health</a>
(405147007) </div>
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<p class="text-label"><label for="citation">Citation: </label></p>
<textarea id="citation">National Guideline Clearinghouse (NGC). Guideline summary: 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2014 Jul 01. [cited 2018 Jul 12]. Available: https://www.guideline.gov</textarea>
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<h2 id="420" class="accordion-title section-420 is-active" role="tab" aria-expanded="true"><a href="#">Recommendations</a></h2>
<div class="accordion-panel is-active" role="tabpanel">
<h3><a href="#">Major Recommendations</a></h3>
<p><div class="content_para"><p><strong>Note from the National Guideline Clearinghouse (NGC)</strong>: National Heart, Lung and Blood Institute (NHLBI) Evidence Statements are included for each recommendation. See detail in the original guideline document under each critical question review.</p>
<p>Each recommendation has been mapped from the NHLBI grading format to the American College of Cardiology/American Heart Association Class of Recommendation/Level of Evidence (ACC/AHA COR/LOE) construct and is expressed in both formats. Because of the inherent differences in grading systems and the clinical questions driving the recommendations, alignment between the NHLBI and ACC/AHA formats is in some cases imperfect. Definitions for the NHLBI strength of recommendation (<strong>A-E, N</strong>) and quality of evidence (<strong>High, Moderate, Low</strong>) and the ACC/AHA levels of the evidence (<strong>LOE: A-C</strong>) and classes of recommendations (<strong>COR: I-III</strong>) are provided at the end of the "Major Recommendations" field.</p>
<p><strong><span style="text-decoration: underline;">Summary of Recommendations for Lifestyle Management</span></strong></p>
<p><strong>Diet</strong></p>
<p><em>Low-density lipoprotein cholesterol (LDL-C): Advise adults who would benefit from LDL-C lowering* to</em>:</p>
<ol style="list-style-type: decimal;" start="1">
<li>Consume a dietary pattern that emphasizes intake of vegetables, fruits, and whole grains; includes low-fat dairy products, poultry, fish, legumes, nontropical vegetable oils, and nuts; and limits intake of sweets, sugar-sweetened beverages, and red meats. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong>
<ol style="list-style-type: lower-alpha;">
<li>Adapt this dietary pattern to appropriate calorie requirements, personal and cultural food preferences, and nutrition therapy for other medical conditions (including diabetes). </li>
<li>Achieve this pattern by following plans such as the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, the U.S. Department of Agriculture (USDA) Food Pattern, or the AHA Diet. </li>
</ol>
</li>
<li>Aim for a dietary pattern that achieves 5% to 6% of calories from saturated fat. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong> </li>
<li>Reduce percent of calories from saturated fat. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong> </li>
<li>Reduce percent of calories from <em>trans</em> fat. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong> </li>
</ol>
<p><em>Blood pressure (BP): Advise adults who would benefit from BP lowering to</em>:</p>
<ol style="list-style-type: decimal;" start="1">
<li>Consume a dietary pattern that emphasizes intake of vegetables, fruits, and whole grains; includes low-fat dairy products, poultry, fish, legumes, nontropical vegetable oils, and nuts; and limits intake of sweets, sugar-sweetened beverages, and red meats. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong>
<ol style="list-style-type: lower-alpha;">
<li>Adapt this dietary pattern to appropriate calorie requirements, personal and cultural food preferences, and nutrition therapy for other medical conditions (including diabetes). </li>
<li>Achieve this pattern by following plans such as the DASH dietary pattern, the USDA Food Pattern, or the AHA Diet. </li>
</ol>
</li>
<li>Lower sodium intake. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong> </li>
<li>a. Consume no more than 2,400 mg of sodium/d; b. Further reduction of sodium intake to 1,500 mg/d can result in even greater reduction in BP; and c. Even without achieving these goals, reducing sodium intake by at least 1,000 mg/d lowers BP. <strong>NHLBI Grade: B (Moderate); ACC/AHA COR: IIa; ACC/AHA LOE: B</strong> </li>
<li>Combine the DASH dietary pattern with lower sodium intake. <strong>NHLBI Grade: A (Strong); ACC/AHA COR: I; ACC/AHA LOE: A</strong> </li>
</ol>
<p><strong>Physical Activity</strong></p>
<p><em>Lipids</em></p>
<ol style="list-style-type: decimal;" start="1">
<li>In general, advise adults to engage in aerobic physical activity to reduce LDL-C and non-high-density lipoprotein cholesterol (non–HDL-C): 3–4 sessions per week, lasting on average 40 minutes per session, and involving moderate- to vigorous-intensity physical activity. <strong>NHLBI Grade: B (Moderate); ACC/AHA COR: IIa; ACC/AHA LOE: A</strong> </li>
</ol>
<p><em>BP</em></p>
<ol style="list-style-type: decimal;" start="1">
<li>In general, advise adults to engage in aerobic physical activity to lower BP: 3 to 4 sessions per week, lasting on average 40 minutes per session, and involving moderate- to vigorous-intensity physical activity. <strong>NHLBI Grade: B (Moderate); ACC/AHA COR: IIa; ACC/AHA LOE: A</strong> </li>
</ol>
<p class="Note">*Refer to the NGC summary <a href="/web/20180712204842/https://www.guideline.gov/content.aspx?id=48337" title="Guideline #10477">2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines</a>.</p>
<p>See Tables 7-10, 13, 15, and 16 in the original guideline document for additional diet and physical activity guidelines and resources.</p>
<p><span style="text-decoration: underline;"><strong>Definitions</strong></span>:</p>
<p><strong>NHLBI Grading of the Strength of Recommendations</strong></p>
<table border="1" summary="NHLBI Grading of the Strength of Recommendations">
<thead>
<tr>
<th valign="top">Grade</th>
<th valign="top">Strength of Recommendation*</th>
</tr>
</thead>
<tbody>
<tr>
<th class="Center" valign="top">A</th>
<td valign="top"><strong>Strong recommendation</strong><br/>
<br/>
There is high certainty based on evidence that the net benefit† is substantial.</td>
</tr>
<tr>
<th class="Center" valign="top">B</th>
<td valign="top"><strong>Moderate recommendation</strong><br/>
<br/>
There is moderate certainty based on evidence that the net benefit is moderate to substantial, or there is high certainty that the net benefit is moderate.</td>
</tr>
<tr>
<th class="Center" valign="top">C</th>
<td valign="top"><strong>Weak recommendation</strong><br/>
<br/>
There is at least moderate certainty based on evidence that there is a small net benefit.</td>
</tr>
<tr>
<th class="Center" valign="top">D</th>
<td valign="top"><strong>Recommendation against</strong><br/>
<br/>
There is at least moderate certainty based on evidence that there is no net benefit or that risks/harms outweigh benefits.</td>
</tr>
<tr>
<th class="Center" valign="top">E</th>
<td valign="top"><strong>Expert opinion ("There is insufficient evidence or evidence is unclear or conflicting, but this is what the Work Group recommends.")</strong><br/>
<br/>
Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, unclear evidence, or conflicting evidence, but the Work Group thought it was important to provide clinical guidance and make a recommendation. Further research is recommended in this area.</td>
</tr>
<tr>
<th class="Center" valign="top">N</th>
<td valign="top"><strong>No recommendation for or against ("There is insufficient evidence or evidence is unclear or conflicting.")</strong><br/>
<br/>
Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, unclear evidence, or conflicting evidence, and the Work Group thought no recommendation should be made. Further research is recommended in this area.</td>
</tr>
</tbody>
</table>
<p class="Note">*In most cases, the strength of the recommendation should be closely aligned with the quality of the evidence; however, under some circumstances, there may be valid reasons for making recommendations that are not closely aligned with the quality of the evidence (e.g., strong recommendation when the evidence quality is moderate, such as smoking cessation to reduce cardiovascular disease [CVD] risk or ordering an electrocardiogram [ECG] as part of the initial diagnostic work-up for a patient presenting with possible myocardial infarction [MI]). Those situations should be limited and the rationale explained clearly by the Work Group.</p>
<p class="Note">†Net benefit is defined as benefits minus risks/harms of the service/intervention.</p>
<p><strong>NHLBI Quality Rating of the Strength of Evidence</strong></p>
<table border="1" cellspacing="1" cellpadding="3" summary="National Heart, Lung and Blood Institute (NHLBI) Quality Rating of the Strength of Evidence">
<thead>
<tr>
<th valign="top">Type of Evidence</th>
<th valign="top">Quality Rating*</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Well-designed, well-executed† randomized controlled trials (RCTs) that adequately represent populations to which the results are applied and directly assess effects on health outcomes. </li>
<li>Meta-analyses of such studies. </li>
</ul>
Highly certain about the estimate of effect. Further research is unlikely to change confidence in the estimate of effect.</td>
<td valign="top">High</td>
</tr>
<tr>
<td valign="top">
<ul style="list-style-type: disc;">
<li>RCTs with minor limitations‡ affecting confidence in, or applicability of, the results. </li>
<li>Well-designed, well-executed nonrandomized controlled studies§ and well-designed, well-executed observational studies¶. </li>
<li>Meta-analyses of such studies. </li>
</ul>
Moderately certain about the estimate of effect. Further research may have an impact on confidence in the estimate of effect and may change the estimate.</td>
<td valign="top">Moderate</td>
</tr>
<tr>
<td valign="top">
<ul style="list-style-type: disc;">
<li>RCTs with major limitations. </li>
<li>Nonrandomized controlled studies and observational studies with major limitations affecting confidence in, or applicability of, the results. </li>
<li>Uncontrolled clinical observations without an appropriate comparison group (e.g., case series, case reports). </li>
<li>Physiological studies in humans. </li>
<li>Meta-analyses of such studies. </li>
</ul>
Low certainty about the estimate of effect. Further research is likely to have an impact on confidence in the estimate of effect and is likely to change the estimate.</td>
<td valign="top">Low</td>
</tr>
</tbody>
</table>
<p class="Note">*In some cases, other evidence, such as large all-or-none case series (e.g., jumping from airplanes or tall structures), can represent high- or moderate-quality evidence. In such cases, the rationale for the evidence rating exception should be explained by the Work Group and clearly justified.</p>
<p class="Note">†"Well-designed, well-executed" refers to studies that directly address the question; use adequate randomization, blinding, and allocation concealment; are adequately powered; use intention-to-treat analyses; and have high follow-up rates.</p>
<p class="Note">‡Limitations include concerns with the design and execution of a study that result in decreased confidence in the true estimate of the effect. Examples of such limitations include but are not limited to: inadequate randomization, lack of blinding of study participants or outcome assessors, inadequate power, outcomes of interest that are not prespecified for the primary outcomes, low follow-up rates, and findings based on subgroup analyses. Whether the limitations are considered minor or major is based on the number and severity of flaws in design or execution. Rules for determining whether the limitations are considered minor or major and how they will affect rating of the individual studies will be developed collaboratively with the methodology team.</p>
<p class="Note">§Nonrandomized controlled studies refer to intervention studies where assignment to intervention and comparison groups is not random (e.g., quasi-experimental study design).</p>
<p class="Note">¶Observational studies include prospective and retrospective cohort, case-control, and cross-sectional studies.</p>
<p><strong>Applying Classification of Recommendations and Level of Evidence</strong></p>
<table style="font-size: 7pt; font-variant: normal; font-weight: normal; font-style: normal; line-height: normal;" border="1" cellspacing="3" cellpadding="5" summary="Table: Applying Classification of Recommendations and Level of Evidence">
<thead>
<tr>
<td valign="top" colspan="2" scope="col"> </td>
<th class="Center" valign="top" colspan="6" scope="col">Size of Treatment Effect</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top" rowspan="4" colspan="2" scope="row"> </td>
<td valign="top" rowspan="4"><strong>CLASS I</strong><br/>
<br/>
<em>Benefit >>> Risk</em><br/>
<br/>
Procedure/Treatment <br/>
<strong>SHOULD</strong> be performed/ administered</td>
<td valign="top" rowspan="4"><strong>CLASS IIa</strong><br/>
<br/>
<em>Benefit >> Risk<br/>
Additional studies with focused objectives needed</em><br/>
<br/>
<strong>IT IS REASONABLE</strong> to perform procedure/administer treatment</td>
<td valign="top" rowspan="4"><strong>CLASS IIb</strong><br/>
<br/>
<em>Benefit ≥ Risk <br/>
Additional studies with broad objectives needed; additional registry data would be helpful</em><br/>
<br/>
Procedure/Treatment <br/>
<strong>MAY BE CONSIDERED</strong> </td>
<td valign="top" colspan="3"><strong>CLASS III <em>No Benefit</em></strong><br/>
or <strong>Class III <em>Harm</em></strong> </td>
</tr>
<tr>
<td valign="top" scope="row"> </td>
<th valign="top">Procedure/Test</th>
<th valign="top">Treatment</th>
</tr>
<tr>
<td valign="top" scope="row">COR III:<br/>
No Benefit </td>
<td valign="top">Not helpful</td>
<td valign="top">No proven benefit</td>
</tr>
<tr>
<td valign="top" scope="row">COR III:<br/>
Harm </td>
<td valign="top">Excess cost without benefit or harmful</td>
<td valign="top">Harmful to patients</td>
</tr>
<tr>
<th valign="top" rowspan="3" scope="row">Estimate of Certainty (Precision) of Treatment Effect</th>
<td valign="top"><strong>LEVEL A</strong><br/>
<br/>
Multiple populations evaluated*<br/>
<br/>
Data derived from multiple randomized clinical trials or meta-analyses</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is useful/effective </li>
<li>Sufficient evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation in favor of treatment or procedure being useful/effective </li>
<li>Some conflicting evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation's usefulness/efficacy less well established </li>
<li>Greater conflicting evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
<td valign="top" colspan="3">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is not useful/effective and may be harmful </li>
<li>Sufficient evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
</tr>
<tr>
<td valign="top" scope="row"><strong>LEVEL B</strong><br/>
<br/>
Limited populations evaluated*<br/>
<br/>
Data derived from a single randomized trial or nonrandomized studies</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is useful/effective </li>
<li>Evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation in favor of treatment or procedure being useful/effective </li>
<li>Some conflicting evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation's usefulness/efficacy less well established </li>
<li>Greater conflicting evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
<td valign="top" colspan="3">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is not useful/effective and may be harmful </li>
<li>Evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
</tr>
<tr>
<td valign="top" scope="row"><strong>LEVEL C</strong><br/>
<br/>
Very limited populations evaluated*<br/>
<br/>
Only consensus opinion of experts, case studies, or standard of care</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is useful/effective </li>
<li>Only expert opinion, case studies, or standard of care </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation in favor of treatment or procedure being useful/effective </li>
<li>Only diverging expert opinion, case studies, or standard of care </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation's usefulness/efficacy less well established </li>
<li>Only diverging expert opinion, case studies, or standard of care </li>
</ul>
</td>
<td valign="top" colspan="3">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is not useful/effective and may be harmful </li>
<li>Only expert opinion, case studies, or standard of care </li>
</ul>
</td>
</tr>
</tbody>
</table>
<p class="Note">A recommendation with Level of Evidence B or C does not imply the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even when randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. </p>
<p class="Note">*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use.</p>
<p class="Note">†For comparative-effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.</p></div></p>
<h3><a href="#">Clinical Algorithm(s)</a></h3>
<p><div class="content_para"><p>None provided</p></div></p>
</div>
<h2 id="396" class="accordion-title section-396 is-active" role="tab" aria-expanded="true"><a href="#">Scope</a></h2>
<div class="accordion-panel is-active" role="tabpanel">
<h3><a href="#">Disease/Condition(s)</a></h3>
<p><ul style="list-style-type: disc;">
<li>Cardiovascular disease (CVD) </li>
<li>Hypercholesterolemia </li>
<li>Hypertension </li>
</ul></p>
<h3><a href="#">Guideline Category</a></h3>
<p>Counseling</p>
<p>Management</p>
<p>Prevention</p>
<h3><a href="#">Clinical Specialty</a></h3>
<p>Cardiology</p>
<p>Family Practice</p>
<p>Internal Medicine</p>
<p>Nutrition</p>
<p>Preventive Medicine</p>
<h3><a href="#">Intended Users</a></h3>
<p>Advanced Practice Nurses</p>
<p>Dietitians</p>
<p>Health Care Providers</p>
<p>Nurses</p>
<p>Physician Assistants</p>
<p>Physicians</p>
<h3><a href="#">Guideline Objective(s)</a></h3>
<p><div class="content_para"><p>To evaluate evidence that particular dietary patterns, nutrient intake, and levels and types of physical activity can play a major role in cardiovascular disease (CVD) prevention and treatment through effects on modifiable CVD risk factors (i.e., blood pressure [BP] and lipids)</p></div></p>
<h3><a href="#">Target Population</a></h3>
<p><div class="content_para"><p>Adults 18 years of age and older</p></div></p>
<h3><a href="#">Interventions and Practices Considered</a></h3>
<p><ol style="list-style-type: decimal;" start="1">
<li>Providing dietary advice to lower low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP), including use of dietary plans such as the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, the U.S. Department of Agriculture (USDA) Food Pattern, or the American Heart Association (AHA) Diet
<ul style="list-style-type: disc;">
<li>Reducing percent of calories from saturated fat </li>
<li>Reducing percent of caries from <em>trans </em>fat </li>
<li>Adapting dietary pattern to appropriate calorie requirements, personal and cultural food preferences, and nutrition therapy for other medical conditions </li>
</ul>
</li>
<li>Advising adults to reduce sodium intake </li>
<li>Advising adults to engage in aerobic physical activity to reduce LDL-C and non-high-density lipoprotein cholesterol (non–HDL-C) and to lower BP </li>
</ol></p>
<h3><a href="#">Major Outcomes Considered</a></h3>
<p><ul style="list-style-type: disc;">
<li>Cholesterol/lipid-related measurements: low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, non-HDL-C, apolipoprotein B (ApoB), lipoprotein (a) [Lp (a)], particle number (LDL-P), Apo A–1, % at lipid goal </li>
<li>Blood pressure (BP)-related measurements: systolic BP, diastolic BP, or hypertensive/nonhypertensive, % at BP goal </li>
<li>Incident hypertension </li>
<li>Cardiovascular disease (CVD)-related morbidity or mortality including:
<ul style="list-style-type: disc;">
<li>Acute coronary syndrome: unstable angina, myocardial infarction (MI) </li>
<li>Fatal or nonfatal stroke </li>
<li>Fatal or nonfatal MI (ST-segment elevation myocardial infarction [STEMI] and non-ST elevation myocardial infarction [NSTEMI]). </li>
<li>Coronary revascularization procedures: angioplasty, coronary stent placement, coronary artery bypass </li>
<li>Other atherosclerotic revascularization procedures (carotid endarterectomy) </li>
<li>Fatal heart failure or hospitalization for heart failure </li>
<li>Hospitalization for any coronary heart disease (CHD)/CVD cause </li>
</ul>
</li>
<li>Urinary excretion of albumin sodium (Na) or potassium (K) </li>
<li>Change in medication dose </li>
</ul></p>
</div>
<h2 id="405" class="accordion-title section-405 is-active" role="tab" aria-expanded="true"><a href="#">Methodology</a></h2>
<div class="accordion-panel is-active" role="tabpanel">
<h3><a href="#">Methods Used to Collect/Select the Evidence</a></h3>
<p>Searches of Electronic Databases</p>
<h3><a href="#">Description of Methods Used to Collect/Select the Evidence</a></h3>
<p><div class="content_para"><p><strong><span style="text-decoration: underline;">Literature Search Infrastructure, Search Strategy Development, and Validation</span></strong></p>
<p>The literature search was performed using an integrated suite of search engines that explored a central repository of citations and full-text journal articles. The central repository, search engines, search results, and Web-based modules for literature screening and data abstraction were integrated within a technology platform called the Virtual Collaborative Workspace (VCW). The VCW was custom-developed for the National Heart, Lung and Blood Institute (NHLBI) guidelines initiative.</p>
<p>The central repository consisted of 1.9 million citations and 71,000 full-text articles related to cardiovascular disease (CVD) risk reduction. Citations were acquired from the PubMed, EMBASE, CINAHL®, Cochrane, PsycINFO®, Wilson Science, and Biological Abstracts® databases. Literature searches were conducted using a collection of search engines including TeraText®, Content Analyst, Collexis, and Lucene. These engines were used for executing search strategies, and Lucene was used in correlating the search with screening results.</p>
<p>For every critical question (CQ), a literature search and screening were conducted according to the understanding of the question and the inclusion and exclusion (I/E) criteria that provided specific characteristics of studies relevant to the question. Criteria were framed in the PICOTS format specifying population, intervention, comparator, outcomes, timing, settings, and study design. The question and PICOTS components were translated into a search strategy involving Boolean and conceptual queries.</p>
<p>A Boolean query encodes both inclusion and exclusion rules. It grants access to the maximum quantity of citations, which are then analyzed by text analytics tools and ranked to produce a selection for literature screening that was conducted by two independent reviewers in the VCW's Web-based module. Boolean queries select citations by matching words in titles and abstracts, as well as Medical Subject Headings (MeSH) and subheadings. The number of citations resulting from Boolean queries has ranged from a few hundred to several thousand depending on the question. The text analytics tools suite included:</p>
<ul style="list-style-type: disc;">
<li>A natural language processing module for automated extraction of data elements in support of application of I/E criteria. Frequently extracted and utilized data elements were study size and intervention follow-up period. </li>
<li>Content Analyst for automatically expanding vocabulary of queries, conceptual retrieval, and conceptual clustering. The conceptual query engine employed in Content Analyst leverages word frequency features and co-occurrence in similar contexts to index, select, and rank results. The indexing utilizes the Singular Value Decomposition (SVD) algebraic method. </li>
<li>TeraText for ranking search results and a variety of fast operations on the inverted index. </li>
</ul>
<p>Search strategy development was intertwined with the results of literature screening, which provided feedback on search quality and context. Screened literature was categorized into two subsets: relevant or not relevant to the question. Next, results were analyzed to determine the characteristics of relevant versus not relevant citations. Additional keywords and MeSH terms were used to expand or contract the scope of the query as driven by characteristics of relevant citations. If the revised search strategy produced citations that did not undergo the screening process, then a new batch of citations was added for review. The search strategy refinement/literature review cycle was repeated until all citations covered by the most recent Boolean query had been screened.</p>
<p>Each search strategy was developed and implemented in the VCW. The search strategy was reviewed by the methodologist and Workgroup members, and was available for viewing and printing at any time by Workgroup members and staff collaborating on the systematic review. It was available for execution and supplying literature updates until the literature search and screening cut-off date.</p>
<p>Search strategies for a sample of questions were validated by an independent methodology team. This validation process involved the methodology team developing and executing a separate search strategy and screening a random sample of citations against I/E criteria; these results were compared to the search and screening results developed by the systematic review team. As an additional validation method, studies identified in systematic reviews and meta-analyses were cross-checked against a CQ's "include" list to ensure completeness of the search strategy.</p>
<p><strong><span style="text-decoration: underline;">Process for Literature Review and Application of I/E Criteria</span></strong></p>
<p>Using results from the search strategy, criteria were applied to screen literature for inclusion or exclusion in the evidence base for the CQ. I/E criteria address the parameters in the PICOTS framework and determine what types of studies are eligible and appropriate to answer the CQ. Additional criteria such as sample size restrictions were included by the Panel to fit the context of the CQ.</p>
<p><strong>Pilot Literature Screening Mode</strong></p>
<p>In the Pilot Literature Screening Mode, two reviewers independently screened the first 50 titles/abstracts in the search strategy results by applying I/E criteria. Reviewers voted to include or exclude the publication for full-text review. Reviewers compared their results to ensure that I/E criteria were applied consistently. Discrepancies in votes were discussed, and clarification on criteria was sought from the Panel where appropriate. For example, if criteria were not specific enough to be clearly applied to include or exclude a citation, guidance was sought to more explicitly word criteria.</p>
<p>During this phase, reviewers provided feedback to the Literature Search team about the relevance of search strategy results; this feedback was used to further refine and optimize the search.</p>
<p><strong>Phase 1: Title and Abstract Screening Phase</strong></p>
<p>After the completion of the Pilot Mode phase, two reviewers independently screened search results at the title and abstract level by applying I/E criteria. Reviewers voted to include or exclude the publication for full-text review.</p>
<p>Titles and abstracts where one or both reviewers voted to include the publication advanced to Phase 2, Full-Text Screening. Titles and abstracts where both reviewers voted to exclude were excluded and not reviewed further; these citations were maintained in the VCW and marked as "excluded at title/abstract phase."</p>
<p><strong>Phase 2: Full-Text Screening Phase</strong></p>
<p>Titles and abstracts where at least one reviewer voted to include were reviewed at the full-text level in phase 2. In this phase, two reviewers independently applied I/E criteria to the full-text article and voted for "include," "exclude," or "undecided." The reviewer had to specify the rationale for exclusion (i.e., population, intervention, etc.) in this phase.</p>
<p>Articles where both reviewers voted to include were moved to the "include" list. Articles where both reviewers voted to exclude were moved to the "exclude" list; these citations were maintained in the VCW and identified as "excluded at the full article phase" and the rationale for exclusion was noted. Any article with discrepant votes (i.e., one include and one undecided, one include and one exclude, etc.) advanced to phase 3.</p>
<p><strong>Phase 3: Resolution and Consultation Phase</strong></p>
<p>In this phase, reviewers discussed their vote for "include," "exclude," or "undecided" and cited the relevant criteria for their decision. The two reviewers attempted to achieve consensus through collaborative discussion. If a decision was not reached between the two reviewers, input was sought from the methodologist. If a decision was not reached after consultation with the methodologist, input was sought from the Panel; however, the methodologist had the final decision. The final disposition of the article ("include" or "exclude") was recorded in the VCW along with comments from the adjudication process.</p>
<p>Similar to search strategies being posted and available for viewing on the VCW, all citations screened for a critical question were maintained in the VCW with their reviewer voting status and all collected comments.</p>
<p><strong><span style="text-decoration: underline;">CQ 1 and CQ 2 Search Strategy Results</span></strong></p>
<p>The below listed databases were searched for randomized controlled trials (RCTs), controlled clinical trials, and observational or epidemiologic studies with a time difference between interventions/exposures and outcomes (i.e., cohort studies, case-control studies) and systematic reviews and meta-analyses of these study designs to answer CQ1 and CQ2. Observational and epidemiologic studies or systematic reviews of such studies were eligible for hard health outcomes only.</p>
<ul style="list-style-type: disc;">
<li>PubMed from January 1998 to December 2009 (to April 2012 for CQ2) </li>
<li>CINAHL from January 1998 to July 2008 </li>
<li>EMBASE from January 1998 to July 2008 </li>
<li>PsycINFO from January 1998 to July 2008 </li>
<li>EBM (Evidence-based Medicine) Cochrane Libraries from January 1998 to July 2008 </li>
<li>Biological Abstracts from January 2004 to July 2008 </li>
<li>Wilson Social Sciences Abstracts from January 1998 to July 2008 </li>
</ul>
<p>Duplicate citations which arise from the same citation being found in more than one database were removed from the Central Repository prior to screening.</p>
<p><strong><span style="text-decoration: underline;">CQ3 Search Strategy Results</span></strong></p>
<p>CQ3 was restricted to systematic reviews and meta-analyses. The following databases were searched for evidence to answer this question:</p>
<ul style="list-style-type: disc;">
<li>PubMed from January 2001 to January 2010 </li>
<li>CINAHL from January 2001 to July 2008 </li>
<li>EMBASE from January 2001 to July 2008 </li>
<li>PsycINFO from January 2001 to July 2008 </li>
<li>EBM (Evidence-based Medicine) Cochrane Libraries from January 2001 to July 2008 </li>
<li>Biological Abstracts from January 2001 to July 2008 </li>
<li>Wilson Social Sciences Abstracts from January 2001 to July 2008 </li>
</ul>
<p>Duplicate citations which arise from the same citation being found in more than one database were removed from the Central Repository prior to screening.</p>
<p>See additional details regarding search strategy and criteria in the full panel report supplement Appendices (see the "Availability of Companion Documents" field).</p></div></p>
<h3><a href="#">Number of Source Documents</a></h3>
<p><div class="content_para"><p><strong>Critical Question (CQ) 1 Search Strategy Results</strong></p>
<p>The search produced 6,084 citations. This number of citations includes results from a supplemental search of PubMed for systematic reviews and meta-analyses focused on fatty acids, with publication dates between 1990 and 2009. A natural language processing (NLP) filter was used to identify studies with sample sizes less than 500, for studies reporting hard health outcomes and sample sizes less than 50, for biomarker assessment and risk factor studies. The NLP filter was executed against titles and abstracts, and 2,318 publications were automatically excluded because they were of studies with less than the required sample size. The titles and abstracts of the 3,768 remaining publications were screened against the inclusion/exclusion (I/E) criteria independently by two reviewers, which resulted in the retrieval of 1,237 full-text papers. These papers were independently screened by two reviewers and 1,209 of these publications were excluded on one or more of the I/E criteria. An additional 27 publications were excluded because they were rated as poor quality; 17 were randomized controlled trials (RCTs), 4 were cohort studies, and 6 were systematic reviews or meta-analyses. Twenty-eight articles were included in the Question 1 Evidence Base. Twenty-four were RCTs, 1 was a cohort study, and 3 were systematic reviews or meta-analyses.</p>
<p><strong>CQ2 Search Strategy Results</strong></p>
<p>The search produced 1,382 citations. This number of citations includes results from a supplemental search of PubMed that was extended to April 2012, and which was focused on sodium and hard health outcomes. An NLP filter was used to identify studies with sample sizes less than 500 for studies reporting hard health outcomes and for sample sizes less than 50 for biomarker assessment and risk factor studies. The NLP filter was executed against titles and abstracts. Six hundred and thirty-three publications were automatically excluded using the NLP filter because they were of studies with less than the required sample size. The titles and abstracts of the 749 remaining publications were screened against the I/E criteria independently by two reviewers, which resulted in the retrieval of 271 full-text papers. These papers were independently screened by two reviewers and 225 of these publications were excluded on one or more of the I/E criteria. An additional 5 publications were excluded because they were rated as poor quality; all 5 poor quality studies were RCTs. 46 articles were included in the Question 2 Evidence Base. Sixteen were RCTs, 25 were cohort studies, 1 was a case-control study, and 4 were systematic reviews or meta-analyses.</p>
<p><strong>CQ3 Search Strategy Results</strong></p>
<p>The search produced 843 systematic reviews and meta-analyses. An additional 24 citations published between January 2010 and May 2011 were retrieved from PubMed for review. The titles and abstracts of these 867 publications were screened against the I/E criteria independently by two reviewers which resulted in the retrieval of 184 full-text papers. These papers were independently screened by two reviewers, and 158 of these publications were excluded on one or more of the I/E criteria. The majority of full-text articles that were excluded were excluded because the outcomes did not meet those specified in the criteria. An additional 16 publications were excluded because they were rated as poor quality using the National Heart, Lung and Blood Institute (NHLBI) Quality Assessment Tool for Systematic Reviews and Meta-Analyses. Twenty-six systematic reviews and meta-analyses were eligible for inclusion in the Question 3 Evidence Base. Twenty-five of the 26 included systematic reviews and meta-analyses were published between January 2001 and January 2010. One systematic review by Lin et al. that was published in December 2010 was retained in the body of evidence.</p></div></p>
<h3><a href="#">Methods Used to Assess the Quality and Strength of the Evidence</a></h3>
<p>Weighting According to a Rating Scheme (Scheme Given)</p>
<h3><a href="#">Rating Scheme for the Strength of the Evidence</a></h3>
<p><div class="content_para"><p><strong>Applying Classification of Recommendations and Level of Evidence</strong></p>
<table style="font-size: 7pt; font-variant: normal; font-weight: normal; font-style: normal; line-height: normal;" border="1" cellspacing="3" cellpadding="5" summary="Table: Applying Classification of Recommendations and Level of Evidence">
<thead>
<tr>
<td valign="top" colspan="2" scope="col"> </td>
<th class="Center" valign="top" colspan="6" scope="col">Size of Treatment Effect</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top" rowspan="4" colspan="2" scope="row"> </td>
<td valign="top" rowspan="4"><strong>CLASS I</strong><br/>
<br/>
<em>Benefit >>> Risk</em><br/>
<br/>
Procedure/Treatment <br/>
<strong>SHOULD</strong> be performed/ administered</td>
<td valign="top" rowspan="4"><strong>CLASS IIa</strong><br/>
<br/>
<em>Benefit >> Risk<br/>
Additional studies with focused objectives needed</em><br/>
<br/>
<strong>IT IS REASONABLE</strong> to perform procedure/administer treatment</td>
<td valign="top" rowspan="4"><strong>CLASS IIb</strong><br/>
<br/>
<em>Benefit ≥ Risk <br/>
Additional studies with broad objectives needed; additional registry data would be helpful</em><br/>
<br/>
Procedure/Treatment <br/>
<strong>MAY BE CONSIDERED</strong> </td>
<td valign="top" colspan="3"><strong>CLASS III <em>No Benefit</em></strong><br/>
or <strong>Class III <em>Harm</em></strong> </td>
</tr>
<tr>
<td valign="top" scope="row"> </td>
<th valign="top">Procedure/Test</th>
<th valign="top">Treatment</th>
</tr>
<tr>
<td valign="top" scope="row">COR III:<br/>
No Benefit </td>
<td valign="top">Not helpful</td>
<td valign="top">No proven benefit</td>
</tr>
<tr>
<td valign="top" scope="row">COR III:<br/>
Harm </td>
<td valign="top">Excess cost without benefit or harmful</td>
<td valign="top">Harmful to patients</td>
</tr>
<tr>
<th valign="top" rowspan="3" scope="row">Estimate of Certainty (Precision) of Treatment Effect</th>
<td valign="top"><strong>LEVEL A</strong><br/>
<br/>
Multiple populations evaluated*<br/>
<br/>
Data derived from multiple randomized clinical trials or meta-analyses</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is useful/effective </li>
<li>Sufficient evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation in favor of treatment or procedure being useful/effective </li>
<li>Some conflicting evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation's usefulness/efficacy less well established </li>
<li>Greater conflicting evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
<td valign="top" colspan="3">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is not useful/effective and may be harmful </li>
<li>Sufficient evidence from multiple randomized trials or meta-analyses </li>
</ul>
</td>
</tr>
<tr>
<td valign="top" scope="row"><strong>LEVEL B</strong><br/>
<br/>
Limited populations evaluated*<br/>
<br/>
Data derived from a single randomized trial or nonrandomized studies</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is useful/effective </li>
<li>Evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation in favor of treatment or procedure being useful/effective </li>
<li>Some conflicting evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation's usefulness/efficacy less well established </li>
<li>Greater conflicting evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
<td valign="top" colspan="3">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is not useful/effective and may be harmful </li>
<li>Evidence from single randomized trial or nonrandomized studies </li>
</ul>
</td>
</tr>
<tr>
<td valign="top" scope="row"><strong>LEVEL C</strong><br/>
<br/>
Very limited populations evaluated*<br/>
<br/>
Only consensus opinion of experts, case studies, or standard of care</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is useful/effective </li>
<li>Only expert opinion, case studies, or standard of care </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation in favor of treatment or procedure being useful/effective </li>
<li>Only diverging expert opinion, case studies, or standard of care </li>
</ul>
</td>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Recommendation's usefulness/efficacy less well established </li>
<li>Only diverging expert opinion, case studies, or standard of care </li>
</ul>
</td>
<td valign="top" colspan="3">
<ul style="list-style-type: disc;">
<li>Recommendation that procedure or treatment is not useful/effective and may be harmful </li>
<li>Only expert opinion, case studies, or standard of care </li>
</ul>
</td>
</tr>
</tbody>
</table>
<p class="Note">A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.</p>
<p class="Note">*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use.</p>
<p class="Note">†For comparative-effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.</p>
<p><strong>National Heart, Lung and Blood Institute (NHLBI) Quality Rating of the Strength of Evidence</strong></p>
<table border="1" cellspacing="1" cellpadding="3" summary="National Heart, Lung and Blood Institute (NHLBI) Quality Rating of the Strength of Evidence">
<thead>
<tr>
<th valign="top">Type of Evidence</th>
<th valign="top">Quality Rating*</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top">
<ul style="list-style-type: disc;">
<li>Well-designed, well-executed† randomized controlled trials (RCTs) that adequately represent populations to which the results are applied and directly assess effects on health outcomes. </li>
<li>Meta-analyses of such studies. </li>
</ul>
Highly certain about the estimate of effect. Further research is unlikely to change confidence in the estimate of effect.</td>
<td valign="top">High</td>
</tr>
<tr>
<td valign="top">
<ul style="list-style-type: disc;">
<li>RCTs with minor limitations‡ affecting confidence in, or applicability of, the results. </li>
<li>Well-designed, well-executed nonrandomized controlled studies§ and well-designed, well-executed observational studies¶. </li>
<li>Meta-analyses of such studies. </li>
</ul>