Practice Policies in Anesthesia

Health care reform has become a subject of widespread popular discussion and impassioned national debate. Although most would agree that our system is too expensive, opinions differ widely as to the reforms that should be adopted to make health care less costly while maintaining its high quality. One proposed cost containment mechanism endorsed in several reform plans, including President Clinton's, is the expanded use of practice policies. Practice policies are systematically developed guidelines that seek to channel physician decision-making to pathways of proven clinical efficacy. Theoretically, the use of this strategy should reduce unnecessary care and therefore result in substantial savings without sacrificing quality. This paper will explore the history, development, effectiveness, and implications of practice policies in general and as they relate to anesthesia. The idea of practice standards in medicine is not new. In fact, almost all the generic rules, axioms, treatments, indications, and criteria in medical textbooks can be considered practice policies [1]. Consider this approach to the treatment of bronchitis practiced in Assyria 3500 yr ago: If the patient suffers from a hissing cough if his wind pipe is full of murmurs …, if he has phlegm: bray together roses and mustard in purified oil, drop it on his tongue, fill moreover, a tube with it and blow it into his nostrils. There-after he shall drink several times beer of the first quality; thus he will recover. [2] What is new today, and what has great implications for the way medicine will be practiced in the future, is the way practice policies are being produced and how they are being used. The informal, nearly anonymous, pronouncements made in old textbooks have been replaced by formal, highly exacting methodology for producing guidelines. Of even more concern to some physicians is the use of guidelines as regulatory tools imposed by those outside the medical profession. To these physicians the use of practice policies for quality assurance, utilization review, insurance coverage, and cost containment purposes by insurers, the government, and regulatory bodies is an erosion of the clinical autonomy of the medical profession. Others see the recent surge of interest in practice guidelines as the profession's best hope for accommodating the demands for quality care at the lowest possible price. Moreover, they see practice policies, not as a threat to autonomy, but as a valuable adjunct to the complex task of medical decision-making. As David Eddy observed: Practice policies present a powerful solution to the complexity of medical decisions. They free practitioners from the burden of having to estimate and weigh the pros and cons of each decision. They can connect each practitioner to a collective consciousness, bringing order, direction, and consistency to their decisions. Practice policies provide an intellectual vehicle through which the profession can distill the lessons of research and clinical experiences and put the knowledge and preferences of many people into conclusions about appropriate practices. They provide a natural pathway to convey that information to practitioners. Practice policies are the central nervous system of medical practice. [1] Thus, the debate over practice parameters within the medical profession is a heated one. Given the high stakes involved, it is no surprise that many organizations are interested in practice parameters. To date the combined efforts of many and varied groups have resulted in the publication of more than 1500 practice parameters [3]. The organizations most directly affected by practice policies, the medical specialty societies, also have the longest history of involvement in their development. The American Academy of Pediatrics led the way more than 50 yr ago when it published its guidelines for childhood immunization [4]. Over the years other specialty groups have followed suit. Indeed, most of the standards produced today continue to be the work of various medical specialty societies Figure 1, but during the last several years the health care reform debate has spurred the involvement of the government and many other organizations Figure 2.Figure 1: Number of societies producing practice parameters. (From Kelly JT, Swartwout JE. Development of practice parameters by physician organizations. QRB 1990;16:54-57.)Figure 2: Names of societies that have developed practice parameters. (From Kelly JT, Swartwout JE. Development of practice parameters by physician organizations. QRB 1990;16:54-57.)National medical organizations have a large stake in this movement, as the parameters developed and implemented will govern the way medicine will be practiced into the next century. Accordingly, the American Medical Association (AMA) established the Practice Parameters Partnership and Forum consisting of representatives of the AMA and 18 specialty societies [4]. This group will develop initiatives and attempt to influence policy relative to practice parameters. The Institute of Medicine has begun research into practice parameters and the American College of Physicians has been engaged in its Clinical Efficacy Assessment Project for several years [5]. Evidence of a national commitment to the development of standards in medical practice first surfaced in 1989 with the establishment by Congress of the Agency for Health Care Policy and Research (AHCPR) [6], which was charged with the "development and periodic review and updating … of clinically relevant guidelines, standards of quality, performance measures and medical review criteria …" [7]. AHCPR has issued, or is currently working on, practice guidelines for a wide variety of medical conditions, including cataracts, benign prosthetic hypertrophy, urinary incontinence, pain management, pressure sores, and depression [8]. The Health Care Financing Administration (HCFA), administrator of Medicare, is developing a set of practice guidelines called the Uniform Clinical Data Set [9]. State governments, concerned that federal action will come too slowly, have begun the process of guideline development as well. Florida, Minnesota, Maine, and Vermont have already begun writing practice guidelines into state law, and most other states that have developed health care reform plans may follow suit [10]. For the most part, these state efforts seek to use guidelines already developed at the national level, but some states are considering adapting them to fit perceived local requirements. Private organizations are also at work in this area [9]. The Joint Commission on Accreditation of Health Care Organizations (JCAHO) is developing sets of clinical indicators for various specialties. One of its first sets of indicators deals with anesthesia, and many anesthesia departments are now using these indicators for quality assurance purposes. Another initiative involves the Rand Corporation, a center for health care policy research, working in conjunction with the AMA and the Academic Medical Center Consortium. They are developing Clinical Appropriateness Initiatives. Insurers are also sources for guidelines. The Blue Cross and Blue Shield Association undertook the Technology Evaluation Coverage Project several years ago [5]. In addition, most insurers have developed internal review criteria to assess the appropriateness of care rendered to their policy holders. In anesthesia, the American Society of Anesthesiologists (ASA) has been a leader among medical specialty groups in the development of practice parameters and, as will be seen below, has recently intensified its efforts in this area. Other groups too, some of which were mentioned above, are actively developing standards that will impact anesthesia care. With all the activity, energy, and expense being devoted to practice policies, it is clear that this is one of the most intense areas in health care policy research today. As policies will have such an impact on the practice of medicine in general and in anesthesia in particular, we should be familiar with them and know how they are used and developed. All of these topics will be discussed below. Definitions Guidelines are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances" [11]. Guidelines can be adopted, modified, or rejected according to clinical needs and restraints. They are "developed by a formal process that incorporates the best scientific evidence with expert opinion" [12]. The intent of a guideline, then, is to provide practitioners with a flexible tool that can be used to help deal with a particular circumstance. Guidelines come in many forms [11-13]. Whether they are called review criteria, clinical algorithms, boundary guidelines, or practice parameters, the key point to remember is that guidelines are recommendations that can be accepted, rejected, or modified to fit the circumstances of the case at issue. In contrast, practice standards are more rigidly applied [14]. They carry an implication of compulsion. A standard is an absolute minimum requirement that must be adhered to by a clinician to satisfy the demands of clinically competent care. A practice standard establishes the relevant standard of care from a medical-legal point of view. Standards can be de facto or promulgated [15]. De facto standards are established when good ideas that improve the quality of patient care gain currency among clinicians and become widely accepted as the standard way of managing clinical situations. De facto standards often become promulgated or formally adopted as written regulations by authoritative specialty organizations. A practice policy is the generic term used to describe the general category that encompasses both guidelines and standards in their many forms [14]. Why Are Standards Needed? As mentioned above, the national consensus is that we spend too much money for health care in the United States. One reason that health care is so expensive is that we pay for procedures that are not medically indicated or necessary. Several recent studies have placed the number of procedures performed for inappropriate indications at 10%-30% [16-21]. These unnecessary procedures augment the cost of health care but do nothing to improve its quality. Unnecessary care results largely from a lack of scientific evidence to distinguish forms of treatment that are clinically most effective [22]. Even when data on effectiveness are available, other factors often intervene in physicians' decision-making processes to influence the choice of therapy. These include patient preference, tradition, peer pressure, and the personalities of the physician and the patient [23-25]. Thus, it is obvious that the issue of unnecessary care is a multifactoral problem and no one solution is adequate to address all of the complex interactions involved. However, practice policies represent a beginning in the attempt to contain unnecessary care. Practice policies have come about because of the belief that, by standardizing clinical practice into management strategies of proven efficacy, unnecessary care will be reduced, health care costs will moderate, and the quality of patient care will improve. Although this line of thinking rests upon a sound logical foundation, it assumes that there is scientific data capable of differentiating between competing patient management scenarios in terms of effectiveness of outcome. Unfortunately, these types of data are difficult to derive and do not exist for many clinical situations in which it would be useful [12]. Realizing that, in general, there is a lack of relevant outcome data, the federal government, through the AHCPR, has increased its financial support for outcomes research. In 1993 AHCPR budgeted 48.2 million dollars to support its major outcomes research strategy, the establishment of Patient Outcome Research Teams [26]. There are 14 comprehensive 5-yr studies currently underway. They are comprised of four elements: a review and synthesis of available research data; data collection and analysis to identify practice variations and outcome differences; the development of recommendations regarding the effectiveness and appropriateness of the various management techniques; and the dissemination of the information to health care providers [27]. However valuable these initiatives will be in dealing with the topics they cover, they obviously deal with only a small fraction of the clinical spectrum and their 5-yr scope means that their output will not be available for some time to come. Clearly, the resources allocated so far are a mere fraction of those that will be required if large scale outcomes research, the type that can have a meaningful impact on practice patterns and thus health care costs, is to be undertaken. In anesthesia, the rationale for the adoption of practice policies is different because anesthesiologists do not decide whether patients need surgery. In anesthesia, the driving force behind the development of standards of care is that of patient safety [28,29]. Thus, most anesthesia standards are aimed at mandating practices to improve quality of care and reduce patient risk. What Are Good Guidelines? Good guidelines provide maximum patient benefit while using health care dollars in the most efficient way possible. Therefore, they seek to balance the competing considerations of what is technologically feasible with what is financially practicable. Above all, to be useful, guidelines must have the confidence of those who use them. That is to say, clinicians must be convinced that their use makes a difference in caring for their patients. To engender confidence among practitioners, guidelines must be based on the best available information and developed through a rigorous, standardized process which ensures that all of the available evidence is examined and considered, including cost/benefit information [8,12,30]. They must be specific enough to provide useful guidance as to which course of action is indicated in a particular circumstance, but at the same time they must not be so complex as to be difficult to use. They should be comprehensive enough to deal with all of the nuances of a particular clinical situation, but they should be limited such that they cannot be used to draw unsubstantiated inferences as to topics not expressly covered. In summary, good guidelines, according to the Institute of Medicine, have eight attributes: validity, reliability, clinical applicability, clinical flexibility, clarity, multidisciplinary process of development, scheduled review for warranted revision, and documentation [11]Table 1.Table 1: Characteristics of Useful Guidelines and StandardsaUses of Standards Depending on the group using them and how they are defined, standards can be used for many purposes, but most of these can be grouped under four major subject headings: 1) voluntary guides to clinical management; 2) guidelines for making reimbursement decisions by third-party payers; 3) the standard of care for medical-legal purposes; and 4) tools for measuring quality of care in the quality assurance process. The use of guidelines as a voluntary means of channeling patient care into specific, demonstrably effective patterns has a disappointing history [31,32]. Perhaps this is because the process by which such guidelines are developed is complex and expensive. First, some influential organization must fund the development of the guideline; then, information as to the content and usefulness of the guideline must be disseminated to the practitioner, and finally, the practitioner must realize the value of the guideline and integrate it into his clinical decision-making process. An example of an attempt to change practice patterns through the educational process alone is the Consensus Development Program started by the National Institutes of Health (NIH) in 1977. Under this program, NIH has selected for analysis more than 60 clinical topics. Topics selected usually involve areas of considerable clinical controversy, and the objective is to reach consensus as to the appropriate approach to these clinical questions. Toward this end, the NIH convenes a panel of experts consisting of scientists, physicians, and informed lay persons to review the available scientific data. When the initial review is complete the panel meets in executive session to attempt to reach a consensus on the answers to the questions posed by the topic. A consensus statement containing one or more specific clinical guidelines is then issued and circulated among practicing physicians [31]. In 1987, the Rand Corporation conducted an evaluation of the NIH program [33] which examined 2770 hospital records of patients treated in Washington State before and after each of four NIH Consensus Conferences (the conferences involved treatment of primary breast cancer, steroid receptors in breast cancer treatment, the indications for cesarean sections, and the indications for coronary artery bypass grafting). The objective of the review was to determine the extent to which the conferences stimulated greater compliance with the guidelines recommended by the conferences. Twelve recommendations were tracked. As a baseline, the researchers determined the extent to which practitioners were following the guidelines prior to the conferences and then compared the rate of compliance 12-24 mo after the conferences. Before the conferences the rate of compliance varied between 52% and 57%. The postconference compliance rate was essentially unchanged at 57%. Thus, the reviewers concluded that the NIH conferences were not effective in promoting voluntary adherence to clinical guidelines. Also along these lines is a 1989 study by Lomas et al. [34]. It sought to determine whether the existence of voluntary guidelines as to the appropriate indications for cesarean sections would lower the cesarean section rate. Hospitals and obstetricians in Ontario were surveyed before and after the release of a well publicized and widely distributed consensus statement on the appropriate indications for cesarean section. Although 87%-94% of obstetricians were aware of the guidelines and 82.5%-85% of them were in agreement with the conclusions reached in the guidelines, the cesarean section rate did not change as a result of the issuance of the guidelines. 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