Methodology

The decision to appoint a committee for JNC 7 was based on four factors: the publication of many new hypertension observational studies and clinical trials since the last report was published in 1997; the need for a new, clear, and concise guideline that would be useful to clinicians; the need to simplify the classification of BP; and a clear recognition that the JNC reports did not result in maximum benefit to the public. This JNC report is presented in two separate publications. The initial "Express" version, a succinct practical guide, was published in the May 21, 2003 issue of the Journal of the American Medical Association. The current, more comprehensive report provides a broader discussion and justification for the recommendations made by the committee. As with prior JNC reports, the committee recognizes that the responsible physician's judgment is paramount in managing his or her patients.

Since the publication of the JNC 6 report, the NHBPEP Coordinating Committee, chaired by the director of the NHLBI, has regularly reviewed and discussed studies on hypertension. To conduct this task, the Coordinating Committee is divided into four subcommittees: science base; long-range planning; professional, patient, and public education; and program organization. The subcommittees work together to review the hypertension scientific literature from clinical trials, epidemiology, and behavioral science. In many instances, the principal investigator of the larger studies has presented the information directly to the Coordinating Committee. The committee reviews are summarized and posted on the NHLBI Web site. This ongoing review process keeps the committee apprised of the current state of the science, and the information is also used to develop program plans for future activities, such as continuing education.

During fall 2002, the NHBPEP Coordinating Committee chair solicited opinions regarding the need to update the JNC 6 report. The entire Coordinating Committee provided, in writing, a detailed rationale explaining the necessity for updating JNC 6, outlined critical issues, and provided concepts to be addressed in the new report. Thereafter, the NHBPEP Coordinating Committee chair appointed the JNC 7 chair and an Executive Committee derived from the Coordinating Committee membership. The Coordinating Committee members served on one of five JNC 7 writing teams, which contributed to the writing and review of the document.

The concepts for the new report identified by the NHBPEP Coordinating Committee were used to create the report outline. Based on these critical issues and concepts, the Executive Committee developed relevant medical subject headings (MeSH) terms and keywords to further review the scientific literature. These MeSH terms were used to generate MEDLINE searches that focused on English-language, peer-reviewed, scientific literature from January 1997 through April 2003. Various systems of grading the evidence were considered, and the classification scheme used in JNC 6 and other NHBPEP clinical guidelines was selected. This scheme classifies studies according to a process adapted from Last and Abramson (see Scheme Used for Classification of the Evidence).

In reviewing the exceptionally large body of research literature on hypertension, the Executive Committee focused its deliberations on evidence pertaining to outcomes of importance to patients and with effects of sufficient magnitude to warrant changes in medical practice ("patientoriented evidence that matters," or POEMs). Patient-oriented outcomes include not only mortality but also other outcomes that affect patients' lives and well-being, such as sexual function, ability to maintain family and social roles, ability to work, and ability to carry out daily living activities. These outcomes are strongly affected by nonfatal stroke, HF, CHD, and renal disease; hence, these outcomes were considered along with mortality in the committee's evidencebased deliberations. Studies of physiological endpoints ("disease-oriented evidence," or DOEs) were used to address questions where POEMs were not available.

The Coordinating Committee began the process of developing the JNC 7 Express report in December 2002, and the report was submitted to the Journal of the American Medical Association in April 2003. It was published in an electronic format on May 14, 2003, and in print on May 21, 2003. During this time, the Executive Committee met on six occasions, two of which included meetings with the entire NHBPEP Coordinating Committee. The writing teams also met by teleconference and used electronic communications to develop the report. Twenty-four drafts were created and reviewed repeatedly. At its meetings, the Executive Committee used a modified nominal group process14 to identify and resolve issues. The NHBPEP Coordinating Committee reviewed the penultimate draft and provided written comments to the Executive Committee. In addition, 33 national hypertension leaders reviewed and commented on the document. The NHBPEP Coordinating Committee approved the JNC 7 Express report. To complete the longer JNC 7 version, the Executive Committee members met via teleconferences and in person and circulated sections of the larger document via e-mail. The sections were assembled and edited by the JNC 7 chair and were circulated among the NHBPEP Coordinating Committee members for review and comment. The JNC 7 chair synthesized the comments, and the longer version was submitted to the journal Hypertension in November 2003.

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