Frequently Asked Questions (FAQs), Adult CVD Risk Reduction, Cholesterol, Hypertension, and Obesity Guidelines, NHLBI

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Why does the National Heart, Lung, and Blood Institute (NHLBI) support the development of clinical practice guidelines?

The NHLBI is authorized and mandated under the Public Health Service Act (42 U.S.C. 285b-2) to conduct public and professional education relating to heart, blood vessel, lung, and blood diseases. The Institute recognizes that the results of the medical research it supports will only be able to improve the public health if they are translated into practice. Yet the volume and interpretation of research results can be overwhelming, so clinicians and patients often look to experts to identify, evaluate, and interpret relevant research results in order to aid them in making decisions regarding medical care. The NHLBI addresses this need by supporting the development of clinical practice guidelines by volunteer expert panels.

Guideline development is integral to the NHLBI Strategic Plan, which includes the following as one of its three goals: "To generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in health and to stimulate further scientific discovery."

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What methods does the NHLBI use in developing new guidelines for high blood cholesterol, high blood pressure, and obesity?

The NHLBI has convened three expert panels to develop new clinical practice guidelines on high blood cholesterol, high blood pressure, and obesity, and three work groups to examine the crosscutting issues of risk assessment, lifestyle, and implementation. Common methods are being used by each of the groups to enable future development of integrated cardiovascular risk reduction guidelines.

The panels and work groups use a rigorous evidence-based approach and innovative information technology to identify, review, and evaluate the scientific evidence for specific research questions. The process includes several steps:

Formulating key clinical/scientific questions ("critical questions") of high relevance to clinical practice
Determining the types of studies that will be considered for each critical question ("study eligibility criteria")
Identifying, retrieving, and rating the quality of each relevant study; studies are rated good, fair, or poor using defined criteria based on methods of study design and execution
Summarizing key information from each study in an "evidence table" (e.g., who the participants were, what intervention was delivered, what the control group received, quality of the measurements, study results)
Summarizing the evidence for each critical question, and its components, by developing evidence statements that are graded; components of questions include various outcomes and groups defined by age, gender, presence of another condition; the quality of evidence for each evidence statement is graded as high, moderate, or low based on scientific methodology and strength and consistency of results
Determining clinical practice recommendations based on the evidence and providing an indication of the strength of each recommendation

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Why is it taking so long for the NHLBI expert panels to develop the new guidelines?

The project is conducting systematic reviews of the scientific evidence and developing recommendations simultaneously in five topic areas: hypertension, high blood cholesterol, overweight/obesity, lifestyle, and risk assessment. Five expert panels and work groups are employing a rigorous evidence-based approach to identify, review, and evaluate the scientific evidence for 16 critical questions, each with multiple components such as various outcomes and subgroups with differing characteristics. Thousands of articles are being screened and evaluated for inclusion. The clinical practice recommendations are developed based on detailed review of the evidence for each of the critical questions and their components (see also questions 2 and 4).

The project is large, complex, and detailed; it has many components and requires attention to various relevant and interrelated issues. The systematic evidence-review process is in effect a research study of the scientific literature, and so it entails many steps and requires careful attention to detail.

The process also includes a public review and comment period for the draft guidelines, thereby subjecting the recommendations to wide-scale scrutiny before the reports are finalized. The entire process requires a considerable amount of time to complete.

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Does the NHLBI guidelines development process meet the standards in the two Institute of Medicine (IOM) reports released in March 2011?

The two companion reports on systematic reviews and guideline development released by the IOM in March 2011 are highly relevant to the NHLBI efforts: "Finding What Works in Health Care: Standards for Systematic Reviews" and "Clinical Practice Guidelines We can Trust" The standards recommended in the reports were developed to ensure objective, transparent, and scientifically valid reviews and guidelines.

Although the IOM standards were released after development of the new NHLBI adult cardiovascular guidelines had begun, the NHLBI guidelines process was designed to be consistent with the principles described in the IOM report, i.e., to minimize bias by using a rigorous scientific approach to evidence reviews and basing all recommendations on the evidence. The NHLBI process meets or exceeds many current practices being used for guidelines development.

The NHLBI methods meet many of the IOM standards for systematic reviews, including:

Formulating the topic for the systematic review
Finding all the relevant studies
Rating the quality of the individual studies
Synthesizing the body of evidence
Releasing reports describing the reviews and findings

The NHLBI methods also meet many of the IOM clinical practice guidelines standards, including:

Basing the guidelines on systematic reviews
Establishing evidence foundations for recommendations
Grading the strength of recommendations
Obtaining external reviews of draft reports

One aspect where the NHLBI process differs from the new IOM standards is in the inclusion of patient and consumer representatives on guidelines panels. Rather than including them on the panels, the NHLBI process engages patient and consumer representatives during the public comment period and again later when the guidelines move toward implementation.

Now that the IOM standards are available, the NHLBI is considering the feasibility of adopting the remainder of the IOM standards in its future guideline efforts.

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How were members of the expert panels selected?

The NHLBI initiated a public call for nominations for panel membership to ensure adequate representation of key specialties and stakeholders and appropriate expertise, among expert panel and work group members. A nomination form was posted on the NHLBI website for several weeks and was also distributed to a Guidelines Leadership Group that had given advice to the NHLBI on its guideline efforts. Information from nomination forms, including contact information and areas of clinical and research expertise, was entered into a database.

After the close of the call for nominations, NHLBI staff reviewed the database and selected a potential chair and co-chair for each expert panel and work group. The potential chairs and co-chairs provided to the NHLBI Conflict of Interest (COI) disclosures and a copy of their curriculum vitae. The NHLBI Ethics Office reviewed the COI disclosures and cleared or rejected persons being considered as chairs and co-chairs. The selected chairs then were formed into a Guidelines Executive Committee, which worked with the NHLBI to select panel members from the list of nominees.

The NHLBI received 440 nominations for potential panel members with appropriate expertise for the task. Panel selection focused on creating a diverse and balanced composition of members. Panel members were selected based on their expertise in the specific topic area (e.g., high blood pressure, high blood cholesterol, and obesity) as well as in specific disciplines including primary care, nursing, pharmacology, nutrition, exercise, behavioral science, epidemiology, clinical trials, research methodology, evidence-based medicine, guideline development, guideline implementation, systems of care, or informatics. The panels also include, as voting ex officio members, senior scientific staff from the NHLBI and other NIH Institutes who are recognized experts in the topics under consideration.

See also question 8.

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What will the new guidelines include? Will they be similar to previous NHLBI guidelines?

The adult cardiovascular guideline reports on hypertension, high blood cholesterol, and obesity will consist of:

A description of the methods used in conducting the systematic evidence review
The research/scientific questions ("critical questions") being addressed
The types of studies sought ("study eligibility criteria")
A summary of the literature identified that met the study eligibility criteria
Evidence statements (graded as high, moderate, or low evidence quality based on scientific methodology and strength of results), and the rationale behind the evidence statements, with references
Clinical practice recommendations based on the evidence, with an indication of the strength of each recommendation and the rationale behind the recommendations
Reference citations

Reports on risk assessment and lifestyle also will be released that will include the same types of information.

The previous guidelines were not limited to recommendations from detailed systematic reviews, as these guidelines will be. The previous guidelines did not have separate systems for grading evidence statements and grading recommendations, which these guidelines will have, as recommended by recent IOM reports.

The new guidelines will contain clinical recommendations based on systematic reviews only for a limited number of key questions. Therefore, they will be more narrowly focused than previous NHLBI guidelines, but they will be based on a more rigorous systematic review process. In addition, all the guideline reports — high blood pressure, high blood cholesterol, obesity, risk assessment, and lifestyle — will be more parallel in approach and structure than previous reports.

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If only a few questions are being addressed, what about recommendations in areas that are not addressed in the guidelines? Also, when will new questions be addressed?

This set of guidelines will only include recommendations that are based on systematic evidence reviews, most of which were conducted specifically for the purpose of developing these guidelines. However, the panels were free to use other recent systematic reviews of good or fair quality, as assessed by the project methodologists, in formulating their recommendations. Other sources of systematic reviews include the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ) Evidence-Based Practice Centers, and researchers who have published their reviews.

Recommendations in the new guidelines will replace previous recommendations on the same topics. The NHLBI expects to support additional critical questions after publication of this set of guideline reports.

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How are conflicts of interest (COI) identified and managed?

Before their selection, potential panel members were considered based on their previously reported COIs as well as their expertise. When invited, they disclosed to the NHLBI relationships that might be considered to be a COI with the panel's deliberations. The disclosures were reviewed by the Ethics Office at the NHLBI. Panel chairs were selected to assure that each panel had at least one co-chair with no COI. The need to disclose conflicts during deliberations and recuse themselves from voting related to their conflicts was provided to the panel members in their acceptance letter, based upon the information they had disclosed. This approach was discussed with the panels as a whole at their first meeting.

Prior to considering the evidence, the Guidelines Executive Committee, comprising chairs from the three panels and three work groups, developed its own policy to be used during deliberations (see: http://www.nhlbi.nih.gov/guidelines/cvd_adult/coi-rwi_policy.htm).The policy requires panel and work group members to disclose their interests to their respective panels and work groups and recuse themselves whenever they believe their interests would compromise the integrity of a particular vote.

The importance of COI issues and the need to adhere rigorously to the Guidelines Executive Committee policy have been reiterated by chairs at the meetings of panels and work groups throughout the process. During meetings, panel members disclose their potential COI and recuse themselves from voting on evidence statements and recommendations relevant to areas of their stated COI. The outcomes of all votes, including the numbers for and against and the number of recusals, will be included in all final reports.

In accordance with standard practice in the field and to ensure transparency, the individual disclosures of all panel and work group members will be included in all reports released to the public.

The systematic evidence review process is designed to ensure that all of the evidence to be examined is gathered and graded using methods that minimize bias. Individual studies relevant to each critical question are identified by computer searches and rated as to their quality. The rating is done by impartial contractors who are trained in assessing the quality of studies, but who are not content experts. Methodologists promote objectivity by guiding the panels and work groups on grading the level of evidence using pre-specified criteria.

The panels are convened by the NHLBI, but they are not official government advisory committees. Therefore, the panel rather than the NHLBI controls how COI disclosures and recusals of panel members are managed. The NHLBI is unable to verify any disclosures or identify any omissions.

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When will the new guidelines be released?

The draft guidelines are expected to be available for public review and comment in 2012. The five reports (hypertension, cholesterol, obesity, risk assessment, lifestyle) will be released one at a time throughout the year, as they are completed. Public comment will last one month for each report.

At a plenary session at the American Heart Association Scientific Sessions on November 14, 2011, chairs of the expert panels for each of the three adult cardiovascular guidelines — hypertension, cholesterol, and obesity — will present, for the first time, the critical questions that their respective panels are addressing. They will describe how the evidence is being identified and evaluated. In a separate session, leaders of the risk assessment, lifestyle, and implementation work groups will provide a status update and describe their methods.

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Are the NHLBI-sponsored guidelines official government policy? Are they written by government employees?

The NHLBI-sponsored clinical guidelines are developed by voluntary expert panels convened by the NHLBI and are, therefore, not official government positions. However, they may inform policy decisions of other government agencies and other groups.

The evidence statements and recommendations that comprise the main content of the guidelines are developed and written by the voting panel members, who are volunteers who donate their time and offer their expertise to enable development of high-quality guidelines that can foster the best care for patients and improve the public's health. Some scientifically qualified NHLBI staff also serve as voting panel members.

Other NHLBI staff are responsible for providing direction to the contractors, supporting and guiding the panels and work groups throughout the process, reviewing and editing the draft reports for consistency and clarity, and arranging for publication of the final documents.

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How are the guidelines paid for, and how is the work supported?

The NHLBI is part of the NIH, a component of the U.S. Department of Health and Human Services. Development of the guidelines, including the systematic review process, is supported by funds appropriated for the NHLBI and overseen and facilitated by NHLBI staff, who provide direction on the processes and coordinate efforts across the panels and work groups and with the contractors.

Two NHLBI contracts provide the resources needed by the expert panels and work groups to conduct the systematic reviews and develop the guidelines. The contracts were selected through open solicitations for their expertise and experience in systematic reviews and literature search capabilities. Staff from the methodology contract work closely with NHLBI staff and the expert panels and work groups to provide guidance and support for defining and developing the critical questions and study eligibility criteria, summarizing the evidence, and guiding the panels in grading evidence statements based on pre-specified criteria. Staff from the other support contract carry out the literature searches, determine which studies meet the eligibility criteria, assess the quality of individual studies, and create tables containing key characteristics of each study.

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October 2011

Frequently Asked Questions (FAQs) About the Adult Cardiovascular Guidelines: Hypertension, Cholesterol, and Obesity

Questions

Answers

Frequently Asked Questions (FAQs)
About the Adult Cardiovascular Guidelines:
Hypertension, Cholesterol, and Obesity