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The Expert Panel's goal was development of comprehensive evidence-based guidelines addressing all of the major CV risk factors to assist pediatric care providers—pediatricians, family practitioners, nurses and nurse practitioners, physician assistants, and registered dietitians—in both the promotion of CV health and the identification and management of specific risk factors from infancy to young adulthood. An initial assessment indicated that an innovative approach would be needed to develop a comprehensive integrated product for the following reasons:
The Expert Panel defined 14 critical questions for the literature search (Table 1-1) and the risk factors to be addressed (Table 12). The first phase of the evidence review focused on critical questions 19, which address the association between the development of atherosclerosis and the presence and intensity of CVD risk factors in childhood and adolescence. The second phase of the evidence review addressed critical questions 1014, which aim to assess the evidence for the safety and efficacy of reduction of each risk factor and the impact of risk factor change on the atherosclerotic process.
In addition to the typical RCTs, systematic reviews, and meta-analyses, two additional types of studies were considered to provide evidence pertaining to the development of atherosclerosis. Longitudinal observational studies were included to assess the tracking of risk factors from youth to adulthood and the relationship of risk factors in youth to the development of atherosclerosis. From the many available observational studies in the literature, the Panel identified the 12 listed in Table 13 for inclusion in the evidence review. The panel used several criteria to evaluate which studies should be in the evidence review, including sample size, and for longitudinal studies the length of followup. In general, the studies were large, averaging more than 1,000 subjects. Smaller studies that had long-term followup allowing evaluation of the relationship between risk factors identified in infancy and early childhood and adolescent and adult endpoints were also included. In addition, natural history studies of genetic disorders known to alter CV risk status were included to provide models of the consequences of prolonged risk exposure or risk protection.
The Expert Panel selected a literature search start date of January 1,1985, roughly 5 years before the previous expert panel process that had generated guidelines for the management of cholesterol in childhood, the National Cholesterol Education Program's Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents, which was published in 1992. From an initial group of more than 1 million titles published between January 1, 1985, and June 30, 2007, the search was refined to ultimately include 648 studies: 50 systematic reviews, 33 meta-analyses, 293 RCTs, 194 observational studies, and, in addition, 78 sets of guidelines relevant to pediatric CVD prevention, which were provided as reference material. Each of the first four listed types of studies underwent full text review and abstraction of critical information into evidence tables; each study was graded individually using a unique algorithm developed for these Guidelines. Details of the search methodology and the abstraction and individual study grading processes are provided in Appendix A. Methodology. The evidence tables are available electronically on the NHLBI Web site at http://www.nhlbi.nih.gov/health-pro/guidelines/current/cardiovascular-health-pediatric-guidelines/index.htm.
Expert Panel members were grouped into subcommittees to focus on specific risk factors according to their respective areas of expertise, with many Expert Panel members participating on more than one subcommittee. In addition, two oversight committees were formed: (1) a Science Team to ensure high scientific quality of the entire evidence review and Guidelines development process and (2) a Clinical Team to maintain the relevance of the recommendations to clinical practice throughout Guidelines development. The Science Team, led by Samuel S. Gidding, M.D., addressed the first nine critical questions and summarized the evidence for the origins of atherosclerosis in childhood and the evidence for the role of risk factors in the atherosclerotic process in Section II. State of the Science: Cardiovascular Risk Factors and the Development of Atherosclerosis in Childhood. For each risk factor, the Expert Panel provided an overview of the evidence, focusing on those studies it believed provided the most important information. These summaries are provided in the risk factor-specific sections of this document. Because of the volume and complexity of the literature review, specific information on every study is provided only in the evidence tables. The risk factor subcommittees critically evaluated the body of evidence relative to each risk factor, using an evidence grading system from the American Academy of Pediatrics (AAP) (Table 14). As shown in Table 14, the AAP evidence grading system was modified to incorporate genetic natural history studies in the Grade B evidence category. Each risk factor subcommittee then formulated age-specific recommendations with grade and strength of recommendation assigned using the AAP grading system, based on consideration of the entire body of evidence used in developing each recommendation. The age categories corresponded with the system used by the AAP publication Bright Futures: Guidelines for Health Supervision of Infants, Children and Adolescents. Each risk factor subcommittee reached internal consensus before presenting its recommendations to the full Expert Panel. The final recommendations were then reviewed and approved by the entire Expert Panel. Additional information on the Guidelines development process is provided in Appendix A. Methodology. A draft Guidelines document was reviewed by multiple professional societies and by many individuals within the National Institutes of Health, the Centers for Disease Control and Prevention, and relevant U.S. Department of Health and Human Services organizations. The Guidelines also underwent a 30-day public comment period. In total, individual responses were developed for more than 800 comments.
Section II. State of the Science: Cardiovascular Risk Factors and the Development of Atherosclerosis in Childhood summarizes all the evidence linking the presence of risk factors in childhood and adolescence to the presence and severity of the atherosclerotic process as assessed both pathologically and by imaging studies. An overview of the role of screening for CV risk factors in children is addressed in Section III. Screening for Cardiovascular Risk Factors. The next eight sections (IVXI) address individual risk factors. Each risk factor section begins with a brief description of the current status of the risk factor in childhood and adolescence. Since this kind of information is often not available from studies that are included in evidence reviews, selected references are used to provide the context within which the recommendations were developed. This text is followed by the Expert Panel's written summary of the evidence review relative to the specific risk factor. As described above, Expert Panel members provided an overview of the evidence, focusing on those studies that in their expert opinions provide the most important information and identifying deficiencies in the evidence. Specific information on each study is provided in the evidence tables available through the NHLBI Web site at http://www.nhlbi.nih.gov/health-pro/guidelines/current/cardiovascular-health-pediatric-guidelines/index.htm. The conclusions of the Expert Panel's review of the evidence are then summarized, accompanied by the evidence grades and the strength of the recommendation. Each risk factor section ends with the Expert Panel's age-specific recommendations, accompanied by supportive actions, which represent suggestions developed by Expert Panel consensus to support implementation of the recommendations. The recommendations are integrated across risk factors and developmentally across age groups into the Integrated Cardiovascular Health Schedule (Section XV), which summarizes the age-specific recommendations for all of the risk factors. To optimize accessibility, references are grouped by risk factor and are listed sequentially at the end of each section. References from the evidence review are identified by the unique PubMed identifier (PMID) number that appears in bold text. Additional references do not include the PMID number.
By addressing the major population-based risk factors for CVD in a single evidence-based set of Guidelines, the aim is to support pediatric care providers in optimizing CV health in infancy, early childhood, and adolescenceBy extending risk factor modification into childhood, our goal is to reduce the development of clinical CVD in the future lives of children.
Table 11. Development of the Evidence Base: Critical Questions
Table 13. Selected Observational Studies
EVIDENCE QUALITY GRADES FOR THE BODY OF EVIDENCE
GUIDELINE DEFINITIONS FOR EVIDENCE-BASED STATEMENTS
 NCEP Expert Panel of Blood Cholesterol Levels in Children and Adolescents. National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics 1992;89:495-501. (PM:1741227)
 American Academy of Pediatrics Steering Committee on Quality Improvement and Management. Classifying recommendations for clinical practice guidelines. Pediatrics 2004;114:874-877.
 Hagan JF, Duncan PM, eds. 2008. Bright Futures: Guidelines for Health Supervision of Infants, Children and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.
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