IN 1989, the Agency for Healthcare Policy and Research (AHCPR) was created by public law. In 1990, Richard Stein, M.D., President of the American Society of Anesthesiologists (ASA), was advised by an agency within the AHCPR of new legislation to develop, review, and update clinical practice guidelines. In 1991, the ASA established an Ad Hoc Committee on Practice Parameters.
Practice standards are authoritative statements or rules of minimum requirements for clinical practice. Standards for Basic Intraoperative Monitoring are the classic example (e.g. , pulse oximetry). A standard may be modified only under unusual circumstances (e.g. , extreme emergencies).
Practice guidelines are systematically developed recommendations for patient care that describe a basic management strategy or a range of basic management strategies. Guideline recommendations are supported by analysis of the current literature and by a synthesis of expert opinion, open forum commentary, clinical feasibility data, and consensus surveys. Guidelines are not intended as standards or absolute requirements. They may be adopted, modified, or rejected according to clinical needs and constraints.
Practice advisories are systemically developed reports that are intended to assist decision making in areas of patient care in which scientific evidence is insufficient. Advisories provide a synthesis and analysis of expert opinion, clinical feasibility data, open forum commentary, and consensus surveys. Advisories are not intended as standards or guidelines. They may be adopted, modified, or rejected according to clinical needs and constraints.
Before 1990, the ASA had produced Standards and Guidelines. The best known of these was the Standard for Basic Anesthetic Monitoring, which was first approved in 1986. Guidelines had also been developed for Ambulatory Care, Continuing Medical Education, Critical Care, and others. However, the new parameters were to be designed to address clinical practice pathways relating “how to, when to,” and so forth. In many ways, this was medicine's response to the utilization by insurance and managed care companies of “black box” methodology to retrospectively deny or allow charges for care.
This Editorial View accompanies the following article: Practice Guidelines for Pulmonary Artery Catheterization: An updated report by the American Society of Anesthesiologists Task Force on Pulmonary Artery Catheterization. Anesthesiology 2003; 99:988–1014.
The Ad Hoc Committee was composed of anesthesiologists selected by type of practice and geographic location. The Committee would select a topic for a parameter, obtain approval from the Board of Directors and the House of Delegates (HOD), and then recommend a task force to be appointed by the president of the ASA. A chairman would be appointed, and a methodologist trained in developing parameters would be hired as a consultant. A comprehensive literature search would be done and the guideline would be developed based on evidence-based data, in addition to consensus or expert opinion. A draft would be developed and circulated to experts and other interested anesthesiologists. An open forum or two would be conducted at a major anesthesia meeting to obtain feedback. The completed document would then be presented to the HOD of the ASA, where it could be approved or rejected but not modified on the floor of the House. This has been one of the most important reasons for any success this venture has had.
After 2 yr of experience in hiring consultants as methodologists, our committee recommended that a full-time methodologist be hired as a cost-saving measure. Richard Connis, methodologist for the Difficult Airway Guidelines from 1991–1993 was hired first, and in 1994 David Nickinovich was also employed. These two Ph.D. methodologists work in Seattle, Washington, under the direction of Robert Caplan, M.D.
To obtain wide dissemination of our parameters, we have been fortunate to have each one accepted for publication by Anesthesiology. When the ASA approved the concept of practice parameters in 1990, it was suggested that the parameter should be revised or subject to sunset laws after 5 yr. The Agency for Healthcare, Research and Quality (the renamed AHCPR) established a National Guideline Clearing House for parameters, which has accepted each of the ASA's products. The public seems to use this Clearing House as the first source to access most parameters. However, the Clearing House omits any parameter that has not been updated in a 5-year time frame. Obviously, timely revisions are important.
Our committee has intentionally allowed the time frame to increase for two reasons. First, if the 5-year time frame were adhered to, it would be necessary to initiate the revision only 3 yr after publication. Second, a significant outlay of money is required to revise a parameter, and our members volunteer many hours of their valuable time. What about the Clearing House? Most, if not all of our guidelines, are directed to anesthesiologists and not the public. However, our guidelines do receive a number of hits each month, which I expect are from the public or other healthcare professionals who do not routinely access Anesthesiology. We have made the decision to increase the time frame and are willing to accept any potential downside.
The issue of legal consequences always comes up. The general impression is that more cases have been won than lost because of guidelines. In anesthesia, the major problem has been when monitoring or equipment is way below standard and a bad result occurs after treatment. Proper documentation is key in avoiding adverse legal action. No member of our committee has ever been asked to testify on guidelines in an official capacity; if one were to testify, that member would testify as an individual. Certainly, the member's position on the committee would undeniably add weight to the testimony.
A task force was convened to develop a guideline on the “Ideal Practice of Anesthesiology.” However, after considerable effort and discussion, the task force elected not to develop such a guideline, which they believed already existed in previous statements issued by the ASA. The ASA HOD has also rejected a guideline. However, to meet the concerns of our members, the task force rewrote the guideline, which passed in the next year. As chair of the Committee, my view is that the HOD gives final approval to the topics selected. A best faith effort is used to develop a good guideline. The HOD has the ultimate authority and responsibility to approve or reject the guideline.
It is very difficult to develop a guideline authored by multiple societies. The problems mount in geometric proportions. In obstetrics, a turf war developed over the words immediately available . The strategy has been to select a task force and appoint members of other specialties as consultants to our task force as individuals and not as official representatives. With the exception of the Conscious Sedation Guideline, ASA has not sought the endorsement of other specialty societies.
The committee will seek HOD approval in October to develop a guideline on sleep apnea. Approval is also being sought to develop a guideline on pacemakers and implantable defibrillators. Consideration has been given to developing a guideline on pediatric anesthesia. However, it has been decided not to proceed to avoid the conflict about “who should administer anesthesia to a pediatric patient.” If a member believes a specific guideline should be developed, that member may contact me as chair, or any member of the committee. The ASA Newsletter includes an annual update on practice parameters to communicate to members the plans for either new guidelines or guideline revisions.
In summary, the guideline movement will continue as long as the HOD approves both the activities and the funding. Every effort is being made to be fiscally prudent. Fewer meetings are being held for each guideline being developed, but some face-to-face meetings must be held to clarify controversial issues. It takes approximately $150,000 to develop each guideline. This is substantially less than what other organizations spend per guideline, mainly because of the willingness of our members to volunteer their valuable time in developing a guideline. I hope this will provide our readers with more insight into the guideline process.