- Email: [email protected]
Practice guidelines: the radiology perspective
Practice Guidelines: The Radiology Perspective Milton J. Guiberteau, MDa,b, Pamela A. Wilcox, RN, MBAc, Sandra Bjork, RN, JDc
Clinical practice guidelines have emerged as a reality for medical practitioners over the past 20 years. Although virtually all groups interested in the development of practice guidelines hope for improvements in patient care, secondary expectations vary widely among those using them. Their use in daily practice by physicians has met with resistance from barriers including concerns of “cookbook” medicine, a loss of autonomy, and increased professional liability. The recent experience of the ACR in addressing these challenges illustrates that physicians are receptive to steps perceived to mitigate the risks accompanying the use of guidelines as well as to efforts to increase their understanding of implementing guidelines in clinical practice. The experiences of other medical societies and an inventory of future trends reveal additional challenges associated with the use of practice guidelines, as third parties look to guidelines as points of reference for gauging the performance of health care providers. Key Words: Practice guidelines, ACR, standards J Am Coll Radiol 2004;1:92-97. Copyright © 2004 American College of Radiology
It is impossible for a physician to analyze explicitly all the decisions faced in a typical day. The existence of policies eases this burden. Because policies evolve from hundreds of sources, the treatment of an individual patient benefits from the judgments of many physicians instead of being determined by the abilities and values of a single physician. —David Eddy [1]
clinical practice guidelines originated, what they are, and, perhaps as important, what they are not. As an aid to the reader’s understanding of often confusing terminology, we have provided a glossary of some commonly employed terms at the conclusion of this article.
INTRODUCTION
BACKGROUND
From the beginning of the specialty, radiologists have sought to define clinical procedures through informal protocols for both diagnostic and therapeutic purposes. Given the initial dependence on ionizing radiation as the medium for practice, it is understandable that such efforts were deemed essential to ensure effectiveness, quality, and safety. As technology has evolved to include non-radiation-based modalities, the need for protocols has only increased. Although there is considerable difference in scope and complexity between these informal proprietary documents relating to technique and those of nationally sponsored guidelines for radiological practice, they share a number of characteristics that make their use familiar to radiologists. However, as in other medical specialties, radiological practice guidelines detailing procedure indications, the qualifications and responsibilities of personnel, and specifications of radiological care have often met with skepticism and/or confusion by their potential users. For these documents to achieve their intended purposes, it is helpful for radiologists to have an understanding of where and how the concept of
Although since the 1970s, advocates such as David Eddy, MD, PhD, had been writing about the need to move from informal, practice-based policies to formal, evidenced-based practice guidelines, it was not until the late 1980s that the movement toward practice guidelines gained momentum. In 1985, there were 10 physician organizations that had developed practice parameters, but by 1990, that number had increased to 26, with 10 additional physician organizations developing plans for implementation of guidelines [2]. What brought about this change? Some hypothesize that it was caused by the convergence of evidence of unnecessary or inappropriate care, a need to reduce health care costs, and the emergence of a promising methodology for developing guidelines and standards [3]. (The various names that have been applied to these endeavors are defined in the glossary.) Because a major source of inappropriate health care was attributed to “inadequate production, dissemination and use of information” leading to significant variation in patient care decisions, practice guidelines were thought to be at least one part of the solution [3]. Although the medical community was prompt in recognizing the significance of clinical practice policies as potential tools to improve the quality of patient care, the keen interest by state and federal governments, managed care organizations, payers, and other groups outside the physician medical community in the development of practice guidelines became an immediate concern. Thus, since the beginning of the guideline movement, physician organizations, including the American
a
St. Joseph Radiology Associates, Houston, Texas University of Texas Health Science Center, Houston, Texas c American College of Radiology, Reston, Virginia Corresponding author and reprints: Milton J. Guiberteau, MD, St. Joseph Radiology Associates, P.O. Box 27705, Houston, TX 77227-7705; e-mail: [email protected] b
92
© 2004 American College of Radiology 0091-2182/04/$30.00 ● DOI 10.1016/j.jacr.2003.11.013
Guiberteau, Wilcox, Bjork/Journal of the American College of Radiology 93
Medical Association (AMA), have held fast to the position that they must be involved in the development of practice guidelines “to ensure that practice parameters are properly developed and that quality improvement, rather than cost containment, serves as the foundation for their development” [4]. THE EVOLUTION OF PRACTICE GUIDELINES Physicians have used informal guidelines in making treatment decisions since the earliest days of medicine. Examples of informal guidelines include statements in textbooks, journal articles, and even local “standards of care” that may be established by nothing more than hallway conversations among physicians. With the increase in medical knowledge and the explosive growth in new technology, diagnosis and treatment decisions became more and more complex, and informal guidelines simply were not adequate to provide optimal quality of care, patient safety, and effective outcomes. Add to that the scrutiny of the outside forces described above, and the development of formal practice guidelines became inevitable if medicine were to continue to evolve toward an effective focus on quality patient care. When Congress created the Physician Payment Review Commission in 1986, the medical establishment was forced to take seriously the implementation of practice guidelines. It quickly became clear that if organized medicine did not take the lead, the government would. Thus, in 1989, the AMA established two working groups to “address the development and implementation of practice parameters by physician organizations” [5]. A coordinating body, the Practice Parameters Partnership was formed for the activities of the medical profession relative to practice parameters, and included the ACR and 13 other medical specialty societies, the Agency for Healthcare Policy and Research (now the Agency for Healthcare Research and Quality), the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital Association, and the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services). The Practice Parameters Forum, including 80 physician organizations, was established to provide “the scientific expertise and broad-based clinical representation necessary to ensure the development of scientifically sound, clinically relevant practice parameters” [5]. By the late 1980s, the guideline movement had begun in earnest, with government agencies, the medical community, and payers all developing practice guidelines, each bringing their own motivations and processes to the effort. EXPECTATIONS FOR PRACTICE GUIDELINES Although nearly all groups interested in the development of practice guidelines hope for enhancements in patient care, overall expectations depend largely on particular points of view [6]. Physicians primarily seek improvements in the quality of clinical decisions and patient care outcomes, but they also look for updates in medical care practices and reassurance regarding the appropriateness of their care. Employers, insurers, and other payers want to decrease practice variations and costs. Health care organizations, large provider groups, and hospitals want to increase efficiency and improve risk management.
Utilization reviewers seek to identify outliers and inappropriate care. Medical specialty societies may attempt to define “turf” to protect the right to perform and collect reimbursement for procedures. Lawyers may view them as tools in malpractice litigation. Such diversity of expectations and potential uses throughout the health care system contributes to confusion and wariness by physicians of what practice guidelines are and how they will be used. USE IN DAILY PRACTICE Proponents of practice guidelines recognized early on that there are obstacles to their adoption in daily practice. Leape [3] suggested that implementation was “more likely to occur when there are incentives for use, such as peer pressure or concerns about professional liability.” However, these incentives are often outweighed by perceived disadvantages that serve as formidable barriers to physician use. For some, there is a resentment of what might be seen as “cookbook medicine,” which may interfere with the individualization of care and limit reliance on physician judgment. For others, in spite of the potential for a reduction of legal risk through the consistent use of practice guidelines, there are often fears of increased exposure to inappropriate medicolegal action when they deviate from the recommendations, even for good reasons [6]. Physicians have consistently expressed concerns that guidelines that are too rigid in their recommendations may exacerbate the undesirable consequences of use. For these and other reasons, physicians expect and seek relief through some degree of flexibility in clinical practice documents. FLEXIBILITY IN PRACTICE GUIDELINES Because documents providing specifications for clinical practice usually pertain generically to large groups of patients rather than specific patients, physicians employing these recommendations should be allowed flexibility in altering them when applied to individual patients or special circumstances. By definition, policies developed as “standards” are intended to be applied rigidly and should be followed in virtually all cases, whereas “guidelines” are intended to be more flexible and should be followed in most cases, with appropriate deviation permitted [7]. In much of medicine, determining which patient care policies should be standards and which should be guidelines is often governed by the extent and certainty to which outcomes expected by employing the policy are known and by the desirability of the expected outcomes. Not surprisingly, this process is easier in theory than in practice, because there are many circumstances in which the necessary information regarding outcomes and preferences is not precisely known or there is legitimate disagreement among both experts and practicing physicians. Because of these uncertainties, the reality is that there are few true standards in medical practice. With this and other issues in mind, the ACR recently retitled the majority of its “standards” as “practice guidelines.” (See “The ACR Experience” below.) Although a seemingly semantic action, in reality, the change places the ACR practice guidelines in a more flexible category of protocols. This may aid in mitigating a
94 Journal of the American College of Radiology/ Vol. 1 No. 2 February 2004
perceived barrier to use by some radiologists and may encourage a broader incorporation into radiological practice. Such flexibility may also have the added benefit of facilitating the evolution of radiological practice, because more rigid guidelines may hinder the prompt incorporation of technological innovations and new medical information.
cisely known. However, it may play a role in whether a physician is sued at all and, if so, whether the suit is settled and on what terms. It is also clear that it is in the best interest of radiologists to document deviation from guideline recommendations when there is significant potential for uncertainty in the outcome from the expected.
LEGAL ISSUES: A SPECIAL CONSIDERATION
THE ACR EXPERIENCE
An early expectation was that if practice guidelines were developed by a credible physician-based organization, physicians when using standardized clinical protocols in medicolegal proceedings could be held to be within the standard of care. It was also hoped that such standardization might have the added advantage of reducing variability in expert witness testimony. However, attendant with these possible benefits was the recognition that practice guidelines could have the potential to increase liability for physicians who do not comply with their recommendations. Although these are interesting theories, and there is some anecdotal evidence for each, it is difficult to document whether such scenarios occur in meaningful numbers. In 1994, Hyams et al. [8] published an analysis of the role of practice guidelines in malpractice litigation. It was based on a survey of two malpractice carriers and 960 randomly selected medical malpractice attorneys. Of 259 claims opened from 1990 to 1992, 17 involved guidelines. In 12 cases, guidelines were used against the physician, and in 4, they were used in favor of the physician. Of the 12 in which they were used by the plaintiff’s attorney, 1 resulted in a jury verdict for the defendant, 8 settled for the plaintiff, 1 closed with no payment, and 2 remained open. Of the 4 cases in which guidelines were used by the defense, 1 resulted in a verdict for the plaintiff, 1 settled with no payment, and 2 remained open. It is somewhat more difficult to measure how many times the review of practice guidelines might have been considered by the plaintiff attorney to determine that a malpractice action was not worth pursuing. Hyams et al. [8] reported that 27% of the attorneys surveyed reported that a practice guideline influenced their decision to drop or settle a case. The Physician Insurers Association of America (PIAA), an association of approximately 60 medical malpractice companies owned or operated by physicians and dentists, joined with the ACR in a review of their claims data to evaluate the impact of ACR standards on the outcome of radiology claims. This 1997 study looked at claims since 1990, when the ACR standards were first issued. However, because the PIAA data shows that it takes an average of 6.25 years from the time of patient encounter to a jury verdict, the data were limited. The ACR and the PIAA are in the process of updating this survey. Nonetheless, the early data demonstrated that compliance with the standards could produce “good quality radiological care while minimizing liability actions,” leading to the conclusion that the ACR standards are good risk management tools in daily practice [9]. It seems fair to conclude that the extent to which adherence to, or departure from, the practice standards or guidelines of a medical society is relevant to the issue of whether a defendant in a malpractice case has met the standard of care is not pre-
In response to the increased interest in the clinical guideline movement in the late 1980s, the ACR approved its first 9 practice policies, called “standards,” in 1990. The development of ACR “model standards” quickly expanded to include the various subspecialties of radiology. As of May 2003, there were 121 ACR standards available for use. However, despite the support of the ACR membership for the development of standards, there have been some recurring concerns. Because the expressed benefits of guidelines cannot be realized without physician acceptance and compliance, mitigating such concerns is a crucial task for the developing organizations. In this respect, radiology has been no different from other medical specialties. The recent experience of the ACR in dealing with these challenges illustrates that physicians are receptive to steps perceived to reduce the risks accompanying the use of guidelines as well as to efforts to increase their understanding of implementing guidelines in clinical practice. One contentious issue for ACR standards has been a resistance to the inclusion of specific physician requirements directed toward the qualification and maintenance of competence, such as numbers of procedures and continuing education credits. A second major concern of the membership has been the perception that the existence of standards increases the malpractice exposure of radiologists. Over the years, much of this controversy has centered on whether the name “standards” has serious legal implications and if changing the name to “guidelines” or some other title would in fact lessen any potential impact in a legal proceeding. In response to the increasingly polarized debates at the council meeting in 2001, Harvey L. Neiman, MD, then chairman of the ACR Board of Chancellors (BOC), appointed the Task Force on Standards Issues, chaired by Jeffrey Weinreb, MD, to consider several issues, including the following: ● ●
What are the attitudes of the ACR membership toward standards? Should numbers of procedures be used in standards, or are there alternative methods or measures to determine competence?
In an attempt to ascertain the attitudes of the ACR membership toward guidelines, the task force developed a Webbased survey. Despite several notices and reminders, only 54 members participated in the survey out of a potential 9000 to 10,000 members for whom ACR had e-mail addresses. Thus, the issue of member perception remained unanswered. The task force used peer-reviewed literature relative to guideline development as the basis for its research and resulting report on the remaining issues. The conclusions and recommendations of the task force were reported to the BOC in January 2002. The task force recommended that numbers of procedures
Guiberteau, Wilcox, Bjork/Journal of the American College of Radiology 95
should remain in the standards for determining initial qualification to perform a procedure but that any numbers used as measures of continuing competence should only be recommendations. The task force also recommended that the College assess the “value and liabilities in retaining the name ‘standard’, and these should be weighed against the costs both monetary and non-monetary” of changing the name (unpublished report of the ACR, executive summary of the Task Force on Standards Issues). This resulted in two resolutions being presented to the council at the meeting in 2002: one recommending retaining the name “standards” and one recommending a change to “guidelines.” However, despite the work of this task force, the divisiveness within the council over this issue resulted in both resolutions being referred back to the BOC for further investigation. Consequently, in the fall of 2002, E. Stephen Amis, Jr., MD, chairman of the BOC, appointed the Task Force on Standards Name and Construct, to be chaired by Milton J. Guiberteau, MD, to evaluate the issue again. Specifically, the broad charge of this task force included the following: ●
● ●
The task force should delve into all aspects of the name, intent, definition, legal implications, and semantics of the ACR “standards.” The costs of any task force recommendations should be a secondary consideration. The report of the task force should justify its conclusions.
As part of its multiperspective approach, this second task force used the report of the previous task force as a starting point but also employed a considerable number of other resources. These included an e-mail survey of ACR members that resulted in more than 1000 responses, the opinions of two semanticists regarding the definitions of “standards” and “guidelines,” legal opinion from an outside counsel, a survey of other medical societies, and an extensive review of pertinent ACR documents and peer-reviewed literature. Defining Purpose and Intended Use From the outset, the 2002 ACR task force determined that to complete its tasks, a clear, practical statement defining the purpose and intended use of ACR practice documents would be imperative. This statement included the following important elements, namely, that practice documents for radiologists should ● ● ● ●
define practices and technical parameters that should generally produce desired health care outcomes; describe a range of acceptable approaches; assist radiologists in delivering effective, efficient, consistent, and safe medical care; and acknowledge the need for independent medical judgment in their use.
Ultimately, the statement of purpose and intended use was used as a basis for a preamble or foreword to be used in each practice guideline and technical standard. This preamble constitutes a statement of the intent, limitations, and proper understanding of the documents, as well as advice to radiologists on how the documents may best be used in practice. Both
the statement and the preamble were adopted by the ACR Council. Naming the Documents: “Standards” vs. “Guidelines” Although there are a number of titles available and in use among various organizations developing medical practice documents, the two having the most appeal were felt to be “standards” and “guidelines.” To select a name that was reflective of the content of the existing documents, consistent with the task force’s purpose and intended use statement, least likely to be misinterpreted in any medicolegal proceeding, and acceptable to the ACR membership, definitions of the two terms in lay, legal, and medical settings were sought from legal experts and semanticists. These experts concluded that “standards” prescribe mandatory behavior to which a person must conform and connote a rigidity that “guidelines” do not. On the other hand, “guidelines” offer parameters of conduct by which a person can determine his or her own behavior. Further, there was convincing evidence that despite instructions to the contrary, in a legal proceeding, a jury member who hears the word “standard” will instinctively associate it with “standard of care,” “standard of practice,” and “community standard.” Thus, the word “standard” was felt to be more easily manipulated for selective interpretation by interested parties. In the medical practice guideline literature, David M. Eddy, a leader in the clinical practice guideline movement, summarized these issues: “Standards are intended to apply very rigidly,” with deviations “rare and difficult to justify and should trigger thoughts of malpractice,” whereas “guidelines should be followed in most cases but may be tailored to fit individual cases” [7]. The task force also surveyed 12 other major medical societies. Eight use the name “guidelines,” 1 uses both “standards” and “guidelines,” and the other 3 use other terms (not “standards”). Even more indicative perhaps of a need for change was a recent modification of the name of the AMA Practice Parameters Partnership to the Practice Guidelines Partnership. A survey of the ACR membership revealed that approximately 50% of those responding favored the term “guidelines.” Using this information, the task force proposed the classification of the existing ACR standards into two distinctly titled groups. For the majority of ACR-developed practice documents, specifically those addressing the performance of procedures that may require physician judgment, the title of “practice guidelines” seemed appropriate. For a smaller set of documents detailing more rigid equipment specifications and instrument performance monitoring, the title “technical standards” was chosen. Presented in the form of a resolution, these changes were adopted by an overwhelming majority of the ACR Council at the May 2003 annual meeting. Guidelines Approval Process ACR guidelines are developed and refined through a lengthy process of evidence gathering and expert consensus, with ample opportunity at various junctures for member input and commentary on the drafts of the documents. Since the inception of the ACR standards program, these documents have
96 Journal of the American College of Radiology/ Vol. 1 No. 2 February 2004
been debated, amended, and ultimately approved or rejected by the ACR Council at its annual meeting. The 2002 task force medical society survey data indicated that only two other societies had final approval by their memberships similar to that of the ACR. However, in a significant departure from ACR process, those two only allowed approval or disapproval, without modification of the developed policies by their governing bodies. Furthermore, expert legal opinion suggested that to allow changes in these evidence and consensus-based documents in a political forum might risk a loss of coherence and scientific integrity as well as have the potential for adverse legal ramifications. To alleviate these concerns, the second task force recommended and the ACR Council approved specific changes in the approval process. Going forward, the ACR membership will have ample opportunity to provide commentary and input on the draft documents during the development process and during debate at the reference committee hearings at the annual meeting. However, once the reference committee makes its recommendation and presents a final document, the Council will vote to accept or reject the practice guideline or technical standard as presented. No modification to the document will take place on the floor of the Council. To further improve the effectiveness of this process, members of the reference committees will be provided better access to the experts who participated in drafting and commenting on a document during its development. The council also adopted this change. Implementation of Practice Guidelines Both ACR task forces recognized that the educational process for the membership regarding all aspects of practice guidelines and technical standards must be improved if more widespread use in daily practice is to be realized. The second task force outlined a comprehensive program for increasing member understanding and use of ACR guidelines, which was adopted by the ACR Council. Through ACR member input, the task force also recognized that as the number of guidelines increases, they become more cumbersome to use, and the sheer volume can become as overwhelming as trying to sort through the medical literature as required prior to practice guidelines. Staying current as new guidelines are developed and old ones are updated adds to the perceived burden of use by physicians. To this end, the ACR is developing methods for the better referencing of information contained in the guidelines and more facile transition from existing guidelines to the revised versions as they are updated. Opportunities for the ACR As the practice guideline movement approaches the end of its second decade, the focus is increasingly turning to measuring the success of guidelines in improving care and reducing cost. The 2001 ACR task force recommended that the College develop a means to assess the impact of ACR standards on practice. The new ACR Institute for Health Care Policy in Radiology will be tasked with this initiative. The results of these investigations should help the College determine if the considerable time and resources devoted to this effort are worth the outcome.
EXPERIENCE OF OTHER MEDICAL SPECIALTY SOCIETIES Although the focus of the 2002 ACR task force’s survey of 12 medical specialty societies was to investigate the names used for their clinical practice policies and their processes for development and approval, it provided some interesting data with regard to the current status of practice guidelines. Eleven of the 12 organizations do have formal development processes that are evidence and consensus based and use some variation of the Agency for Healthcare Research and Quality’s methodology described by the Institute of Medicine. However, one organization, the College of American Pathologists (CAP), which had previously developed guidelines, had made a decision to cease any further development as of January 2002. A synopsis of its rationale for discontinuing its program may provide a perspective on the future. The CAP Board of Governors made a determination to halt the development of new practice guidelines because they were considered to be resource-intensive to develop, disseminate, and maintain. In addition to the existing barriers to their implementation, the CAP also pointed to studies that indicate that practice guidelines have failed to affect clinical practices or health outcomes. Although these obstacles are very real, given the continued interest on the part of the government, payers, and other purchasers in practice guidelines, the impact of this decision could be considerable. Will pathologists find themselves with practice guidelines imposed by others that may be more cost driven and less patient centered? Will other organizations follow suit? FUTURE TRENDS Health care costs in the United States have continued their upward spiral since 1960, when health care constituted 5.1% of the gross domestic product (GDP), through 2000, when it reached a staggering $1299 billion, 13.2% of the GDP [10]. From all quarters of the health care system, solutions to these rising costs are being sought. In the present economic environment, it is equally important for purchasers of heath care to ensure that their patients receive appropriate value as measured by the quality of care for the dollars paid. More than ever, the government, payers, and especially patients are looking to practice guidelines as tools to measure that quality of care. Groups such as Leapfrog and other large purchasers of medical services are looking at the development of performance measures that are based on practice guidelines. When distributed to the public, such performance ratings, as indicators of the quality and consistency of care, can be used by employers and payers as incentives for prospective patients to select the physicians and hospitals they choose on the basis of these data [11]. Although many practitioners have valid concerns regarding the public release of such performance data, it is clear that if radiologists do not take the lead in developing performance measures for radiology based on their own practice guidelines, others will do it, perhaps with unproven methodology and questionable results. At the ACR FORUM on Quality in May 2003, radiologists, payers, purchasers, and government agencies discussed how performance measures might be implemented in radiology. A
Guiberteau, Wilcox, Bjork/Journal of the American College of Radiology 97
major challenge facing radiology is to find ways to develop performance measures for services that are only one segment of an episode of patient care. Further, it is difficult to develop risk stratification in radiology. The disease-based model used in other areas of medicine does not translate easily to radiology. A possible next step in this arena may be a pilot project to extract some measurable attributes from a small number of ACR practice guidelines or technical standards that address high-volume or high-risk examinations. Such an effort may provide initial insight into the value of this approach. CONCLUSION ●
●
●
●
●
●
As a reality of radiological practice, physicians must familiarize themselves with the benefits while managing the risks of using clinical practice guidelines. An approach to guidelines that allows flexibility for radiologists to use recommendations and information according to their own judgment is one that is most likely to maximize benefits and minimize risks. Although practice guidelines have built-in flexibility, a radiologist who employs an approach substantially different from these guidelines is advised to document in the patient record information sufficient to explain the approach taken. The recent experience of the ACR in addressing radiologists’ concerns regarding practice standards illustrates that physicians are receptive to steps perceived to mitigate the risks accompanying use of guidelines as well as to efforts to increase their understanding of implementing guidelines in clinical practice. On the basis of the recommendations of two recent task forces, the ACR is developing tools to improve understanding and remove barriers to the use of ACR practice guidelines and technical standards through a variety of ACR educational activities; the increased use of electronic means of distribution; and user-friendly, instructed indexing. In response to the demands of payers and other purchasers of care, performance measures that assess the effectiveness of radiology practice guidelines and technical standards in improving the quality and safety of radiologic practice must be developed.
GLOSSARY AMA practice parameters. Strategies for patient management developed to assist physicians in clinical decision making. Practice parameters include standards, guidelines, and other patient management strategies [5]. ACR practice guidelines. Practice guidelines describe recommended conduct in specific areas of clinical practice. They are based on analysis of current literature, expert opinion, open forum commentary, and informal consensus. Guidelines are not intended to be legal standards of care or conduct and may
be modified as determined by individual circumstances and available resources. ACR technical standards. Technical standards describe technical parameters that are quantitative or measurable. They often include specific recommendations for patient management or equipment specifications or settings. Technical standards are based on analysis of current literature, expert opinion, open forum commentary, and informal consensus. Technical standards are intended to set a minimum level of acceptable technical parameters and equipment performance and may be modified as determined by individual circumstances and available resources. Clinical practice guidelines. Systematically developed statements to assist practitioners’ and patients’ decisions about appropriate health care for specific clinical circumstances [5]. Performance measures. Methods or instruments to estimate or monitor the extent to which the actions of a health care provider conform to practice guidelines, medical review criteria, or standards of quality [12, pp. 3-5]. Standard. An unambiguous statement of health care policy that identifies a base line of quality that should result in a satisfactory outcome [13]. REFERENCES 1. Eddy DM. Clinical policies and the quality of clinical practice. N Engl J Med 1982;307:343-7. 2. Kelly JT, Swartwout JE. Development of practice parameters by physician organizations. Qual Rev Bull 1990;16:54-7. 3. Leape L. Practice guidelines and standards: an overview. Qual Rev Bull 1990;16:42-9. 4. American Medical Association. QA: attributes to guide the development of practice parameters. Chicago: American Medical Association; 1990. 5. American Medical Association. Principles of practice guidelines. Chicago: American Medical Association; 1995. 6. Woolf SH. Practice guidelines: a new reality in medicine. III. Impact on patient care. Arch Intern Med 1993;153:2646-55. 7. Eddy DM. Designing a practice policy. Standards, guidelines, options. JAMA 1990;263:3077, 3081, 3084. 8. Hyams AL, Brandenburg JA, Lipsitz SR, et al. Report to physician payment review commission. Practice guidelines and malpractice litigation. Boston: Harvard School of Public Health; 1994. 9. Physician Insurers Association of America. Practice standards claims survey. Rockville (MD): Physician Insurers Association of America; 1997. 10. National Center for Health Statistics. Health, United States, 2003Available at: http://www.cdc.gov/nchs/hus.htm. Accessed: June 26, 2003. 11. Galvin R, Milstein A. Large employers’ new strategies in health care. N Engl J Med 2002;347:939-41. 12. Field MJ, Lohr KN. Clinical practice guidelines. Washington (DC): Institute of Medicine; 1990. 13. Shapiro JH. A new cycle of standards. ACR Bull 1990; July:11-2.
Clinical practice guidelines have emerged as a reality for medical practitioners over the past 20 years. Although virtually all groups interested in the development of practice guidelines hope for improvements in patient care, secondary expectations vary widely among those using them. Their use in daily practice by physicians has met with resistance from barriers including concerns of “cookbook” medicine, a loss of autonomy, and increased professional liability. The recent experience of the ACR in addressing these challenges illustrates that physicians are receptive to steps perceived to mitigate the risks accompanying the use of guidelines as well as to efforts to increase their understanding of implementing guidelines in clinical practice. The experiences of other medical societies and an inventory of future trends reveal additional challenges associated with the use of practice guidelines, as third parties look to guidelines as points of reference for gauging the performance of health care providers. Key Words: Practice guidelines, ACR, standards J Am Coll Radiol 2004;1:92-97. Copyright © 2004 American College of Radiology
It is impossible for a physician to analyze explicitly all the decisions faced in a typical day. The existence of policies eases this burden. Because policies evolve from hundreds of sources, the treatment of an individual patient benefits from the judgments of many physicians instead of being determined by the abilities and values of a single physician. —David Eddy [1]
clinical practice guidelines originated, what they are, and, perhaps as important, what they are not. As an aid to the reader’s understanding of often confusing terminology, we have provided a glossary of some commonly employed terms at the conclusion of this article.
INTRODUCTION
BACKGROUND
From the beginning of the specialty, radiologists have sought to define clinical procedures through informal protocols for both diagnostic and therapeutic purposes. Given the initial dependence on ionizing radiation as the medium for practice, it is understandable that such efforts were deemed essential to ensure effectiveness, quality, and safety. As technology has evolved to include non-radiation-based modalities, the need for protocols has only increased. Although there is considerable difference in scope and complexity between these informal proprietary documents relating to technique and those of nationally sponsored guidelines for radiological practice, they share a number of characteristics that make their use familiar to radiologists. However, as in other medical specialties, radiological practice guidelines detailing procedure indications, the qualifications and responsibilities of personnel, and specifications of radiological care have often met with skepticism and/or confusion by their potential users. For these documents to achieve their intended purposes, it is helpful for radiologists to have an understanding of where and how the concept of
Although since the 1970s, advocates such as David Eddy, MD, PhD, had been writing about the need to move from informal, practice-based policies to formal, evidenced-based practice guidelines, it was not until the late 1980s that the movement toward practice guidelines gained momentum. In 1985, there were 10 physician organizations that had developed practice parameters, but by 1990, that number had increased to 26, with 10 additional physician organizations developing plans for implementation of guidelines [2]. What brought about this change? Some hypothesize that it was caused by the convergence of evidence of unnecessary or inappropriate care, a need to reduce health care costs, and the emergence of a promising methodology for developing guidelines and standards [3]. (The various names that have been applied to these endeavors are defined in the glossary.) Because a major source of inappropriate health care was attributed to “inadequate production, dissemination and use of information” leading to significant variation in patient care decisions, practice guidelines were thought to be at least one part of the solution [3]. Although the medical community was prompt in recognizing the significance of clinical practice policies as potential tools to improve the quality of patient care, the keen interest by state and federal governments, managed care organizations, payers, and other groups outside the physician medical community in the development of practice guidelines became an immediate concern. Thus, since the beginning of the guideline movement, physician organizations, including the American
a
St. Joseph Radiology Associates, Houston, Texas University of Texas Health Science Center, Houston, Texas c American College of Radiology, Reston, Virginia Corresponding author and reprints: Milton J. Guiberteau, MD, St. Joseph Radiology Associates, P.O. Box 27705, Houston, TX 77227-7705; e-mail: [email protected] b
92
© 2004 American College of Radiology 0091-2182/04/$30.00 ● DOI 10.1016/j.jacr.2003.11.013
Guiberteau, Wilcox, Bjork/Journal of the American College of Radiology 93
Medical Association (AMA), have held fast to the position that they must be involved in the development of practice guidelines “to ensure that practice parameters are properly developed and that quality improvement, rather than cost containment, serves as the foundation for their development” [4]. THE EVOLUTION OF PRACTICE GUIDELINES Physicians have used informal guidelines in making treatment decisions since the earliest days of medicine. Examples of informal guidelines include statements in textbooks, journal articles, and even local “standards of care” that may be established by nothing more than hallway conversations among physicians. With the increase in medical knowledge and the explosive growth in new technology, diagnosis and treatment decisions became more and more complex, and informal guidelines simply were not adequate to provide optimal quality of care, patient safety, and effective outcomes. Add to that the scrutiny of the outside forces described above, and the development of formal practice guidelines became inevitable if medicine were to continue to evolve toward an effective focus on quality patient care. When Congress created the Physician Payment Review Commission in 1986, the medical establishment was forced to take seriously the implementation of practice guidelines. It quickly became clear that if organized medicine did not take the lead, the government would. Thus, in 1989, the AMA established two working groups to “address the development and implementation of practice parameters by physician organizations” [5]. A coordinating body, the Practice Parameters Partnership was formed for the activities of the medical profession relative to practice parameters, and included the ACR and 13 other medical specialty societies, the Agency for Healthcare Policy and Research (now the Agency for Healthcare Research and Quality), the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital Association, and the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services). The Practice Parameters Forum, including 80 physician organizations, was established to provide “the scientific expertise and broad-based clinical representation necessary to ensure the development of scientifically sound, clinically relevant practice parameters” [5]. By the late 1980s, the guideline movement had begun in earnest, with government agencies, the medical community, and payers all developing practice guidelines, each bringing their own motivations and processes to the effort. EXPECTATIONS FOR PRACTICE GUIDELINES Although nearly all groups interested in the development of practice guidelines hope for enhancements in patient care, overall expectations depend largely on particular points of view [6]. Physicians primarily seek improvements in the quality of clinical decisions and patient care outcomes, but they also look for updates in medical care practices and reassurance regarding the appropriateness of their care. Employers, insurers, and other payers want to decrease practice variations and costs. Health care organizations, large provider groups, and hospitals want to increase efficiency and improve risk management.
Utilization reviewers seek to identify outliers and inappropriate care. Medical specialty societies may attempt to define “turf” to protect the right to perform and collect reimbursement for procedures. Lawyers may view them as tools in malpractice litigation. Such diversity of expectations and potential uses throughout the health care system contributes to confusion and wariness by physicians of what practice guidelines are and how they will be used. USE IN DAILY PRACTICE Proponents of practice guidelines recognized early on that there are obstacles to their adoption in daily practice. Leape [3] suggested that implementation was “more likely to occur when there are incentives for use, such as peer pressure or concerns about professional liability.” However, these incentives are often outweighed by perceived disadvantages that serve as formidable barriers to physician use. For some, there is a resentment of what might be seen as “cookbook medicine,” which may interfere with the individualization of care and limit reliance on physician judgment. For others, in spite of the potential for a reduction of legal risk through the consistent use of practice guidelines, there are often fears of increased exposure to inappropriate medicolegal action when they deviate from the recommendations, even for good reasons [6]. Physicians have consistently expressed concerns that guidelines that are too rigid in their recommendations may exacerbate the undesirable consequences of use. For these and other reasons, physicians expect and seek relief through some degree of flexibility in clinical practice documents. FLEXIBILITY IN PRACTICE GUIDELINES Because documents providing specifications for clinical practice usually pertain generically to large groups of patients rather than specific patients, physicians employing these recommendations should be allowed flexibility in altering them when applied to individual patients or special circumstances. By definition, policies developed as “standards” are intended to be applied rigidly and should be followed in virtually all cases, whereas “guidelines” are intended to be more flexible and should be followed in most cases, with appropriate deviation permitted [7]. In much of medicine, determining which patient care policies should be standards and which should be guidelines is often governed by the extent and certainty to which outcomes expected by employing the policy are known and by the desirability of the expected outcomes. Not surprisingly, this process is easier in theory than in practice, because there are many circumstances in which the necessary information regarding outcomes and preferences is not precisely known or there is legitimate disagreement among both experts and practicing physicians. Because of these uncertainties, the reality is that there are few true standards in medical practice. With this and other issues in mind, the ACR recently retitled the majority of its “standards” as “practice guidelines.” (See “The ACR Experience” below.) Although a seemingly semantic action, in reality, the change places the ACR practice guidelines in a more flexible category of protocols. This may aid in mitigating a
94 Journal of the American College of Radiology/ Vol. 1 No. 2 February 2004
perceived barrier to use by some radiologists and may encourage a broader incorporation into radiological practice. Such flexibility may also have the added benefit of facilitating the evolution of radiological practice, because more rigid guidelines may hinder the prompt incorporation of technological innovations and new medical information.
cisely known. However, it may play a role in whether a physician is sued at all and, if so, whether the suit is settled and on what terms. It is also clear that it is in the best interest of radiologists to document deviation from guideline recommendations when there is significant potential for uncertainty in the outcome from the expected.
LEGAL ISSUES: A SPECIAL CONSIDERATION
THE ACR EXPERIENCE
An early expectation was that if practice guidelines were developed by a credible physician-based organization, physicians when using standardized clinical protocols in medicolegal proceedings could be held to be within the standard of care. It was also hoped that such standardization might have the added advantage of reducing variability in expert witness testimony. However, attendant with these possible benefits was the recognition that practice guidelines could have the potential to increase liability for physicians who do not comply with their recommendations. Although these are interesting theories, and there is some anecdotal evidence for each, it is difficult to document whether such scenarios occur in meaningful numbers. In 1994, Hyams et al. [8] published an analysis of the role of practice guidelines in malpractice litigation. It was based on a survey of two malpractice carriers and 960 randomly selected medical malpractice attorneys. Of 259 claims opened from 1990 to 1992, 17 involved guidelines. In 12 cases, guidelines were used against the physician, and in 4, they were used in favor of the physician. Of the 12 in which they were used by the plaintiff’s attorney, 1 resulted in a jury verdict for the defendant, 8 settled for the plaintiff, 1 closed with no payment, and 2 remained open. Of the 4 cases in which guidelines were used by the defense, 1 resulted in a verdict for the plaintiff, 1 settled with no payment, and 2 remained open. It is somewhat more difficult to measure how many times the review of practice guidelines might have been considered by the plaintiff attorney to determine that a malpractice action was not worth pursuing. Hyams et al. [8] reported that 27% of the attorneys surveyed reported that a practice guideline influenced their decision to drop or settle a case. The Physician Insurers Association of America (PIAA), an association of approximately 60 medical malpractice companies owned or operated by physicians and dentists, joined with the ACR in a review of their claims data to evaluate the impact of ACR standards on the outcome of radiology claims. This 1997 study looked at claims since 1990, when the ACR standards were first issued. However, because the PIAA data shows that it takes an average of 6.25 years from the time of patient encounter to a jury verdict, the data were limited. The ACR and the PIAA are in the process of updating this survey. Nonetheless, the early data demonstrated that compliance with the standards could produce “good quality radiological care while minimizing liability actions,” leading to the conclusion that the ACR standards are good risk management tools in daily practice [9]. It seems fair to conclude that the extent to which adherence to, or departure from, the practice standards or guidelines of a medical society is relevant to the issue of whether a defendant in a malpractice case has met the standard of care is not pre-
In response to the increased interest in the clinical guideline movement in the late 1980s, the ACR approved its first 9 practice policies, called “standards,” in 1990. The development of ACR “model standards” quickly expanded to include the various subspecialties of radiology. As of May 2003, there were 121 ACR standards available for use. However, despite the support of the ACR membership for the development of standards, there have been some recurring concerns. Because the expressed benefits of guidelines cannot be realized without physician acceptance and compliance, mitigating such concerns is a crucial task for the developing organizations. In this respect, radiology has been no different from other medical specialties. The recent experience of the ACR in dealing with these challenges illustrates that physicians are receptive to steps perceived to reduce the risks accompanying the use of guidelines as well as to efforts to increase their understanding of implementing guidelines in clinical practice. One contentious issue for ACR standards has been a resistance to the inclusion of specific physician requirements directed toward the qualification and maintenance of competence, such as numbers of procedures and continuing education credits. A second major concern of the membership has been the perception that the existence of standards increases the malpractice exposure of radiologists. Over the years, much of this controversy has centered on whether the name “standards” has serious legal implications and if changing the name to “guidelines” or some other title would in fact lessen any potential impact in a legal proceeding. In response to the increasingly polarized debates at the council meeting in 2001, Harvey L. Neiman, MD, then chairman of the ACR Board of Chancellors (BOC), appointed the Task Force on Standards Issues, chaired by Jeffrey Weinreb, MD, to consider several issues, including the following: ● ●
What are the attitudes of the ACR membership toward standards? Should numbers of procedures be used in standards, or are there alternative methods or measures to determine competence?
In an attempt to ascertain the attitudes of the ACR membership toward guidelines, the task force developed a Webbased survey. Despite several notices and reminders, only 54 members participated in the survey out of a potential 9000 to 10,000 members for whom ACR had e-mail addresses. Thus, the issue of member perception remained unanswered. The task force used peer-reviewed literature relative to guideline development as the basis for its research and resulting report on the remaining issues. The conclusions and recommendations of the task force were reported to the BOC in January 2002. The task force recommended that numbers of procedures
Guiberteau, Wilcox, Bjork/Journal of the American College of Radiology 95
should remain in the standards for determining initial qualification to perform a procedure but that any numbers used as measures of continuing competence should only be recommendations. The task force also recommended that the College assess the “value and liabilities in retaining the name ‘standard’, and these should be weighed against the costs both monetary and non-monetary” of changing the name (unpublished report of the ACR, executive summary of the Task Force on Standards Issues). This resulted in two resolutions being presented to the council at the meeting in 2002: one recommending retaining the name “standards” and one recommending a change to “guidelines.” However, despite the work of this task force, the divisiveness within the council over this issue resulted in both resolutions being referred back to the BOC for further investigation. Consequently, in the fall of 2002, E. Stephen Amis, Jr., MD, chairman of the BOC, appointed the Task Force on Standards Name and Construct, to be chaired by Milton J. Guiberteau, MD, to evaluate the issue again. Specifically, the broad charge of this task force included the following: ●
● ●
The task force should delve into all aspects of the name, intent, definition, legal implications, and semantics of the ACR “standards.” The costs of any task force recommendations should be a secondary consideration. The report of the task force should justify its conclusions.
As part of its multiperspective approach, this second task force used the report of the previous task force as a starting point but also employed a considerable number of other resources. These included an e-mail survey of ACR members that resulted in more than 1000 responses, the opinions of two semanticists regarding the definitions of “standards” and “guidelines,” legal opinion from an outside counsel, a survey of other medical societies, and an extensive review of pertinent ACR documents and peer-reviewed literature. Defining Purpose and Intended Use From the outset, the 2002 ACR task force determined that to complete its tasks, a clear, practical statement defining the purpose and intended use of ACR practice documents would be imperative. This statement included the following important elements, namely, that practice documents for radiologists should ● ● ● ●
define practices and technical parameters that should generally produce desired health care outcomes; describe a range of acceptable approaches; assist radiologists in delivering effective, efficient, consistent, and safe medical care; and acknowledge the need for independent medical judgment in their use.
Ultimately, the statement of purpose and intended use was used as a basis for a preamble or foreword to be used in each practice guideline and technical standard. This preamble constitutes a statement of the intent, limitations, and proper understanding of the documents, as well as advice to radiologists on how the documents may best be used in practice. Both
the statement and the preamble were adopted by the ACR Council. Naming the Documents: “Standards” vs. “Guidelines” Although there are a number of titles available and in use among various organizations developing medical practice documents, the two having the most appeal were felt to be “standards” and “guidelines.” To select a name that was reflective of the content of the existing documents, consistent with the task force’s purpose and intended use statement, least likely to be misinterpreted in any medicolegal proceeding, and acceptable to the ACR membership, definitions of the two terms in lay, legal, and medical settings were sought from legal experts and semanticists. These experts concluded that “standards” prescribe mandatory behavior to which a person must conform and connote a rigidity that “guidelines” do not. On the other hand, “guidelines” offer parameters of conduct by which a person can determine his or her own behavior. Further, there was convincing evidence that despite instructions to the contrary, in a legal proceeding, a jury member who hears the word “standard” will instinctively associate it with “standard of care,” “standard of practice,” and “community standard.” Thus, the word “standard” was felt to be more easily manipulated for selective interpretation by interested parties. In the medical practice guideline literature, David M. Eddy, a leader in the clinical practice guideline movement, summarized these issues: “Standards are intended to apply very rigidly,” with deviations “rare and difficult to justify and should trigger thoughts of malpractice,” whereas “guidelines should be followed in most cases but may be tailored to fit individual cases” [7]. The task force also surveyed 12 other major medical societies. Eight use the name “guidelines,” 1 uses both “standards” and “guidelines,” and the other 3 use other terms (not “standards”). Even more indicative perhaps of a need for change was a recent modification of the name of the AMA Practice Parameters Partnership to the Practice Guidelines Partnership. A survey of the ACR membership revealed that approximately 50% of those responding favored the term “guidelines.” Using this information, the task force proposed the classification of the existing ACR standards into two distinctly titled groups. For the majority of ACR-developed practice documents, specifically those addressing the performance of procedures that may require physician judgment, the title of “practice guidelines” seemed appropriate. For a smaller set of documents detailing more rigid equipment specifications and instrument performance monitoring, the title “technical standards” was chosen. Presented in the form of a resolution, these changes were adopted by an overwhelming majority of the ACR Council at the May 2003 annual meeting. Guidelines Approval Process ACR guidelines are developed and refined through a lengthy process of evidence gathering and expert consensus, with ample opportunity at various junctures for member input and commentary on the drafts of the documents. Since the inception of the ACR standards program, these documents have
96 Journal of the American College of Radiology/ Vol. 1 No. 2 February 2004
been debated, amended, and ultimately approved or rejected by the ACR Council at its annual meeting. The 2002 task force medical society survey data indicated that only two other societies had final approval by their memberships similar to that of the ACR. However, in a significant departure from ACR process, those two only allowed approval or disapproval, without modification of the developed policies by their governing bodies. Furthermore, expert legal opinion suggested that to allow changes in these evidence and consensus-based documents in a political forum might risk a loss of coherence and scientific integrity as well as have the potential for adverse legal ramifications. To alleviate these concerns, the second task force recommended and the ACR Council approved specific changes in the approval process. Going forward, the ACR membership will have ample opportunity to provide commentary and input on the draft documents during the development process and during debate at the reference committee hearings at the annual meeting. However, once the reference committee makes its recommendation and presents a final document, the Council will vote to accept or reject the practice guideline or technical standard as presented. No modification to the document will take place on the floor of the Council. To further improve the effectiveness of this process, members of the reference committees will be provided better access to the experts who participated in drafting and commenting on a document during its development. The council also adopted this change. Implementation of Practice Guidelines Both ACR task forces recognized that the educational process for the membership regarding all aspects of practice guidelines and technical standards must be improved if more widespread use in daily practice is to be realized. The second task force outlined a comprehensive program for increasing member understanding and use of ACR guidelines, which was adopted by the ACR Council. Through ACR member input, the task force also recognized that as the number of guidelines increases, they become more cumbersome to use, and the sheer volume can become as overwhelming as trying to sort through the medical literature as required prior to practice guidelines. Staying current as new guidelines are developed and old ones are updated adds to the perceived burden of use by physicians. To this end, the ACR is developing methods for the better referencing of information contained in the guidelines and more facile transition from existing guidelines to the revised versions as they are updated. Opportunities for the ACR As the practice guideline movement approaches the end of its second decade, the focus is increasingly turning to measuring the success of guidelines in improving care and reducing cost. The 2001 ACR task force recommended that the College develop a means to assess the impact of ACR standards on practice. The new ACR Institute for Health Care Policy in Radiology will be tasked with this initiative. The results of these investigations should help the College determine if the considerable time and resources devoted to this effort are worth the outcome.
EXPERIENCE OF OTHER MEDICAL SPECIALTY SOCIETIES Although the focus of the 2002 ACR task force’s survey of 12 medical specialty societies was to investigate the names used for their clinical practice policies and their processes for development and approval, it provided some interesting data with regard to the current status of practice guidelines. Eleven of the 12 organizations do have formal development processes that are evidence and consensus based and use some variation of the Agency for Healthcare Research and Quality’s methodology described by the Institute of Medicine. However, one organization, the College of American Pathologists (CAP), which had previously developed guidelines, had made a decision to cease any further development as of January 2002. A synopsis of its rationale for discontinuing its program may provide a perspective on the future. The CAP Board of Governors made a determination to halt the development of new practice guidelines because they were considered to be resource-intensive to develop, disseminate, and maintain. In addition to the existing barriers to their implementation, the CAP also pointed to studies that indicate that practice guidelines have failed to affect clinical practices or health outcomes. Although these obstacles are very real, given the continued interest on the part of the government, payers, and other purchasers in practice guidelines, the impact of this decision could be considerable. Will pathologists find themselves with practice guidelines imposed by others that may be more cost driven and less patient centered? Will other organizations follow suit? FUTURE TRENDS Health care costs in the United States have continued their upward spiral since 1960, when health care constituted 5.1% of the gross domestic product (GDP), through 2000, when it reached a staggering $1299 billion, 13.2% of the GDP [10]. From all quarters of the health care system, solutions to these rising costs are being sought. In the present economic environment, it is equally important for purchasers of heath care to ensure that their patients receive appropriate value as measured by the quality of care for the dollars paid. More than ever, the government, payers, and especially patients are looking to practice guidelines as tools to measure that quality of care. Groups such as Leapfrog and other large purchasers of medical services are looking at the development of performance measures that are based on practice guidelines. When distributed to the public, such performance ratings, as indicators of the quality and consistency of care, can be used by employers and payers as incentives for prospective patients to select the physicians and hospitals they choose on the basis of these data [11]. Although many practitioners have valid concerns regarding the public release of such performance data, it is clear that if radiologists do not take the lead in developing performance measures for radiology based on their own practice guidelines, others will do it, perhaps with unproven methodology and questionable results. At the ACR FORUM on Quality in May 2003, radiologists, payers, purchasers, and government agencies discussed how performance measures might be implemented in radiology. A
Guiberteau, Wilcox, Bjork/Journal of the American College of Radiology 97
major challenge facing radiology is to find ways to develop performance measures for services that are only one segment of an episode of patient care. Further, it is difficult to develop risk stratification in radiology. The disease-based model used in other areas of medicine does not translate easily to radiology. A possible next step in this arena may be a pilot project to extract some measurable attributes from a small number of ACR practice guidelines or technical standards that address high-volume or high-risk examinations. Such an effort may provide initial insight into the value of this approach. CONCLUSION ●
●
●
●
●
●
As a reality of radiological practice, physicians must familiarize themselves with the benefits while managing the risks of using clinical practice guidelines. An approach to guidelines that allows flexibility for radiologists to use recommendations and information according to their own judgment is one that is most likely to maximize benefits and minimize risks. Although practice guidelines have built-in flexibility, a radiologist who employs an approach substantially different from these guidelines is advised to document in the patient record information sufficient to explain the approach taken. The recent experience of the ACR in addressing radiologists’ concerns regarding practice standards illustrates that physicians are receptive to steps perceived to mitigate the risks accompanying use of guidelines as well as to efforts to increase their understanding of implementing guidelines in clinical practice. On the basis of the recommendations of two recent task forces, the ACR is developing tools to improve understanding and remove barriers to the use of ACR practice guidelines and technical standards through a variety of ACR educational activities; the increased use of electronic means of distribution; and user-friendly, instructed indexing. In response to the demands of payers and other purchasers of care, performance measures that assess the effectiveness of radiology practice guidelines and technical standards in improving the quality and safety of radiologic practice must be developed.
GLOSSARY AMA practice parameters. Strategies for patient management developed to assist physicians in clinical decision making. Practice parameters include standards, guidelines, and other patient management strategies [5]. ACR practice guidelines. Practice guidelines describe recommended conduct in specific areas of clinical practice. They are based on analysis of current literature, expert opinion, open forum commentary, and informal consensus. Guidelines are not intended to be legal standards of care or conduct and may
be modified as determined by individual circumstances and available resources. ACR technical standards. Technical standards describe technical parameters that are quantitative or measurable. They often include specific recommendations for patient management or equipment specifications or settings. Technical standards are based on analysis of current literature, expert opinion, open forum commentary, and informal consensus. Technical standards are intended to set a minimum level of acceptable technical parameters and equipment performance and may be modified as determined by individual circumstances and available resources. Clinical practice guidelines. Systematically developed statements to assist practitioners’ and patients’ decisions about appropriate health care for specific clinical circumstances [5]. Performance measures. Methods or instruments to estimate or monitor the extent to which the actions of a health care provider conform to practice guidelines, medical review criteria, or standards of quality [12, pp. 3-5]. Standard. An unambiguous statement of health care policy that identifies a base line of quality that should result in a satisfactory outcome [13]. REFERENCES 1. Eddy DM. Clinical policies and the quality of clinical practice. N Engl J Med 1982;307:343-7. 2. Kelly JT, Swartwout JE. Development of practice parameters by physician organizations. Qual Rev Bull 1990;16:54-7. 3. Leape L. Practice guidelines and standards: an overview. Qual Rev Bull 1990;16:42-9. 4. American Medical Association. QA: attributes to guide the development of practice parameters. Chicago: American Medical Association; 1990. 5. American Medical Association. Principles of practice guidelines. Chicago: American Medical Association; 1995. 6. Woolf SH. Practice guidelines: a new reality in medicine. III. Impact on patient care. Arch Intern Med 1993;153:2646-55. 7. Eddy DM. Designing a practice policy. Standards, guidelines, options. JAMA 1990;263:3077, 3081, 3084. 8. Hyams AL, Brandenburg JA, Lipsitz SR, et al. Report to physician payment review commission. Practice guidelines and malpractice litigation. Boston: Harvard School of Public Health; 1994. 9. Physician Insurers Association of America. Practice standards claims survey. Rockville (MD): Physician Insurers Association of America; 1997. 10. National Center for Health Statistics. Health, United States, 2003Available at: http://www.cdc.gov/nchs/hus.htm. Accessed: June 26, 2003. 11. Galvin R, Milstein A. Large employers’ new strategies in health care. N Engl J Med 2002;347:939-41. 12. Field MJ, Lohr KN. Clinical practice guidelines. Washington (DC): Institute of Medicine; 1990. 13. Shapiro JH. A new cycle of standards. ACR Bull 1990; July:11-2.