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c Methods for Setting Priorities for Guidelines Development: Medical Malpractice Troyen A. Brennan, M.D., J.D., Ph.D. INTRODUCTION The Institute of Medicine's Committee on Methods for Setting Priorities for Guidelines Developments is preparing a report on priority setting for the Agency for Health Care Policy and Research (AHCPR). AHCPR has requested that the agenda include health care reform. As the policy debate moves into its final days, malpractice reform is critical to congressional proposals. Hence, the role of malpractice litigation as a source of priorities for developing guidelines is of interest to the committee. This paper outlines the proposals regarding malpractice reform now being considered by Congress, reviews the conceptual relationship between the outcome/guideline movement and malpractice underwriting, provides some examples of the ways in which malpractice insurers have set priorities for guidelines development, and then returns to the specific reforms dealing with guidelines in malpractice litigation. For the sake of brevity, the exposition forgoes the usual introductory remarks on the definition and evolution of guidelines. Paper prepared by Troyen A. Brennan, M.D., J.D., Ph.D., professor of law and public health and associate professor of medicine, Harvard School of Public Health, Boston, Massachusetts. 99

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100 SEWING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES MALPRACTICE LITIGATION AND MALPRACTICE REFORM The social functions of malpractice litigation are two fold: the compensation ofthe costs associated with iatrogenic injuries and the deterrence of practices that lead to such injuries. The malpractice plaintiff must prove four points: (1) that he or she was Injured, (2) that the physician or other health care provider failed to meet the standard expected of the reasonable medical practitioner (was negligent), (3) that the negligent action was the proximate cause of the injury, and (4) that there was a dutiful relationship between the health care provider and the injured patient. The injured plaintiff must produce expert testimony by a health care provider on the standard of care or medical custom. The profession sets the standard in most areas of malpractice litigation. Unlike almost all the other areas of tort law, malpractice litigation has been subject to a variety of empirical studies. While tort theorists presume that every negligent injury leads to claims and that claims arise only in cases of a negligent injury, this is simply not the case. There are far more negligent injuries leading to some degree of disability than there are malpractice claims. Indeed the ratio is on the order of seven medical injuries due to negligence for every malpractice claim. This means that the deterrent effect of malpractice litigation must be quite blunted. With estimates of the mortality due to medical malpractice reaching as high as 100,000 deaths per year, one would presume that a great deal of governmental effort would be expended sharpening malpractice litigation by reforms that increase claims. Such efforts would, however, inflame health care providers who can justifiably point to the fact that many malpractice claims are brought in situations in which there is no negligence or no injury. Indeed it would appear that less than a quarter of all malpractice claims are based on negligent medical injuries. Given the emotional impact suits have on physicians, the medical profession particularly, and the health care industry generally, weighs in heavily against any reform that would increase claims, and tends to support legislation that would reduce claims.' Thus, the system that remains is like a traffic cop who lets many speeding motorists pass by and gives tickets to those who are obeying the limits. Since the mid-1980s it has been abundantly clear that, with appropriate legislative enactments, rates of malpractice claims can be reduced. The critical element to so-called tort reform is to reduce the value of any given claim to the critical economic player in a malpractice case, the plaintiff s attorney. Since the plaintiff s attorney typically relies on a contingent fee system, he or she is only All these issues are discussed in more detail in Chapters 1 and 2 of Paul C. Weller, et al., A Measure of Malpractice: Medical Injury, Malpractice Litigation, and Patient Compensation. Cambridge, Mass.: Harvard University Press, 1993.

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APPENDIX C 101 willing to take claims that have certain economic value and a high probability of success. Therefore proponents of tort reform have put into place a series of obstacles to litigation that either force the plaintiff's attorney to put in more time to bring a successful claim or reduce the ultimate amount paid by the defendant or the defendant's insurer. These reforms have included mandatory collateral source offset (the malpractice award is offset by the patient's existing insurance, for example, disability insurance and health insurance), caps on economic and noneconomic damages (especially caps on pain and suffering awards), reductions in the percentage contingency fee allowed, use of screening panels, and mandatory but nonbinding arbitration before a claim can be brought before a court. Empirical research has demonstrated that these reforms "work." Multivariate models have shown that states that have enacted such laws have lower malpractice claims rates than states that have not. The result has been that nationwide the claims per 100 physicians per year has dropped from over 17 in 1986 to somewhere around 11 in 1993. The deflation in claims rates is good news for the malpractice insurance industry. Physicians and hospitals are typically insured for medical malpractice liability for the first dollar of any payment. Since the initial malpractice crisis of the mid-1970s, the malpractice insurance industry has slowly evolved into a market that has a few important commercial elements; a very substantial physician-owned component, often closely allied with state medical societies; and large hospital self-insurers. With the decrease in claims rates, many of these malpractice insurers have become quite wealthy, since the premiums were set in the late 1980s and the early l990s by actuaries who assumed there would be further inflation, rather than deflation, in the malpractice litigation rates. The liability insurers, allied with other professional groups such as the American Medical Association, have formed a strong lobby for further reform. In the national health care debate, they emphasized federal tort reform. While malpractice has long been a state issue, both Republicans and Democrats, no doubt influenced by polls that show the public to be opposed to high rates of malpractice litigation, came together behind malpractice reform. The president's proposal was to enact mandatory, nonbinding arbitration, put into place collateral source offsets, and reduce contingency fees. Alternative plans went quite a bit further and included more severe limits on contingency fees and caps on pain and suffering awards. Some set of constraints on malpractice litigation is likely to be part of a modest congressional package in 1995, especially if the Republican party does well in the November 1994 election. Any such reform will likely be intended to reduce the number of claims, and not the number of medical injuries. In the policy debate, the morbidity and mortality associated with iatrogenic injuries has been largely overlooked. To extend the traffic cop analogy, even larger numbers

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102 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES of speeders are avoiding penalties, while some unjustly accused good drivers may no longer face inappropriate litigation. This is not to say that malpractice insurers and providers are ignorant of or do not care about reduction of medical injuries. In addition to pursuing a legislative strategy, it is very much in their interest to manage risks by reducing the incidence of behaviors that lead to medical injuries. A number of insurers have pursued such risk management and loss control programs aggressively, and some have included use of practice guidelines in these efforts. Clearly, however, these activities arise not as a part of health care reform at the national level, but as a result of sound insurance practice and risk management. MALPRACTICE LITIGATION AND PRACTICE GUIDELINES: THE CONCEPTUAL RELATIONSHIP The conceptual relationship between practice guidelines and malpractice litigation has been carefully explored. In 1988, the Physician Payment Review Commission supported the work of several leading academics in an effort to define the ways in which the guidelines movement and malpractice might interact.2 As noted above, malpractice litigation requires a definition of the standard of care. In any malpractice case, the plaintiff or defense attorney will rely on expert testimony, as well as information from leading textbooks and treatises to try to set forth a definition of the standard of care. Quite obviously, practice guidelines can provide a succinct definition of the standard of care in certain kinds of cases. Therefore it follows that malpractice litigants should be quite interested in using guidelines. However, many medical practice guidelines are not use fill in medical malpractice cases. Practice guidelines first received impetus hom data shoving wide geographic vanations in rates of procedures. As the committee realizes, the work of Wennberg and others set the stage for more systematic reviews of the appropriateness of certain types of procedures by Brook and investigators at He RAND Corporation. Much of the focus in these studies was on inappropriate care, or care that was simply not indicated by the present state of medical knowledge. Guidelines have evolved to define appropriateness and so to reduce 2See Mark Hall, The Defensive Effect of Malpractice Policies in Malpractice Litigation. Law and Contemporary Problems 54(21:1 19-145, 1991; Clark Havighurst, Practice Guidelines as Legal Standards Governing Physician Liability. Law and Contemporary Problems 54~2~:87-117, 1991; and Deborah Garnick, et al., Can Practice Guidelines Reduce the Number of Costs and Costs of Malpractice Claims? Journal of the American Medical Associatior' 266~20~:2856-2860, 1991.

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APPENDLY C 103 rates of various types of procedures.3 Subsequently, many specialty societies and governmental agencies have promoted the development of guidelines. In addition, insurers and integrated providers have carefully incorporated guidelines into their utilization review efforts. These appropriateness guidelines should be distinguished from what might be called standard of care guidelines. The latter are intended to ensure that physicians reach a certain standard of care that provides a reasonable level of safety for the patient. Their major aim is to reduce medical injuries, rather than reducing the numbers of inappropriate procedures. An example sharpens this distinction. Guidelines for cardiac catheterization, along the lines of those developed by the RAND Corporation, are intended to reduce inappropriate cardiac catheterizations. While cardiac catheterization can lead to medical injury, an inappropriate catheterization that does no hann to the patient would not likely be actionable under current malpractice norms.4 Contrast this with the anesthesia guidelines developed first at Harvard University and subsequently adopted by the American Society of Anesthesiologists. These guidelines mandated use of pulse oximetry and end tidal CO2 monitoring in patients under general anesthesia. They were not intended to reduce costs (in fact, the addition of these instruments increases costs), but to reduce the number of injuries resulting Mom the procedures. Their emphasis is on the standard of care and safety, not the costs of medical care. Appropriateness guidelines are of greatest utility to the utilization reviewer; standard of care guidelines are of greatest use to the risk manager. Consider another example. An appropriateness guideline may determine situations u~ which an expensive contrast medium is unnecessary in cardiac catheterization. A standard of care guideline, on the other hand, might specify the more expensive, but safer, medicine for all catheterizations. Safety is the goal of the latter, cost of the former. Eventually, we can expect the distinctions between appropriateness and standard of care guidelines to disappear as vertical integration of health care brings cost concerns even more intrinsically into the clinical encounter. As this occurs, the cost-effectiveness of care will be increasingly salient in malpractice litigation.5 Risk managers will have to consider cost as well as safety In their guidelines. Enterprise liability will speed this development. 3See Troyen A. Brennan, Practice Guidelines and Malpractice Litigation: Collision or Cohesion? Journal of Health Politics, Policy and Law 16(~1~:67-85, 1991. 4The plaintiff could bring a claim that he or she had undergone an inappropriate medical procedure, but without the plaintiff suffering some further injury, the claim would likely not be substantial enough in monetary terms to warrant being brought by a plaintiffs attorney. ssee Havighurst, supra note 2.

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104 SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES In the meantime, however, standard of care guidelines will be used primarily to reduce the incidence of medical injuries. Recognizing this, a number of malpractice insurers have begun to show interest in the promulgation of guidelines. Of course, to do so they must make some decisions about which areas of clinical practice merit attention. SETTING PRIORITIES FOR GUIDELINES DEVELOPMENT THROUGH MEDICAL MALPRACTICE EXPERIENCE Medical malpractice insurers are relatively wealthy today. As a result, they are able to undertake fairly critical analyses of their claims' history and evaluate new methods for loss control. This review and reflection has led to systematic guidelines development efforts by certain companies. Every malpractice insurer carefullyrecords claims according to the specialty of the primary defendant in the case. Most malpractice insurers rely on similar sets of definitions of specialty areas and claims. They also typically have some "denominator data," that is, information on the number of clinical encounters with the average clinician in a given specialty. Therefore insurers can somewhat precisely measure rates of claims per number of patient encounters. This is especially true in such areas as obstetrics (the number of deliveries is usually letdown), emergency medicine (the number of emergency department visits is. calculated), and surgery/anesthesia (the number of cases is typically available). Moreover, they can do some crude benchmarking, especially insofar as there is pooling and sharing of information on claims rates, for instance through the Physicians Insurance Association of America database. Using this information, malpractice insurers can understand whether there are deficiencies within their own pool of insureds. They are also able to trend data over time and observe newly emerging areas of litigation. For example, many malpractice insurers have seen striking increases in the number of claims brought for failure to diagnose in the ambulatory setting. They have also been able to keep a careful eye on obstetrics claims, which are a significant source of liability because of the very high average severity of any claim. Malpractice insurers are also in an enviable position with regard to enforcement of guidelines. While to a large extent controlled by providers themselves, and thus somewhat hesitant about any insured perception of trespassing on clinical judgment, malpractice insurers can insist on the use of certain guidelines or protocols distilled from those guidelines. While few are willing to do so, the at least implied threat of loss of malpractice coverage

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APPENDIX C 105 should one not follow a guideline represents a significant incentive for provider compliance with guidelines.6 The best known example of a malpractice insurer mandating certain guidelines is the Risk Management Foundation's efforts in anesthesia care. In the early 1980s, the Risk Management Foundation, which acts as the claims processor and risk manager for the Controlled Risk Insurance Company, which in turn is the Harvard University captive, off-shore self-insurer for malpractice liability, noted an increase in anoxic brain injuries in patients undergoing general anesthesia. At much the same time, new technologies that allowed continuous monitoring of a patient's respiratory status began to come on line. End tidal CO2 measurements and pulse oxi~netry were expensive, but obviously very helpful to anesthesiologists monitoring patients in surgery. They were not, however, the standard of care. After careful study of the rates of anoxic brain injury and the cost of technology, the Risk Management Foundation mandated use of the new technology and also required that anesthesiologists stay in the operating room at all times. The results of this intervention were extraordinarily gratifying. Rates of malpractice claims and rates of injuries dropped dramatically and, subsequently, so did anesthesiologists' premiums. The guidelines were adopted by the American Society of Anesthesiologists and have become widely accepted.7 The anesthesiology guidelines are an excellent example of standard of care guidelines. They require additional costs (for the purchase of new technology) in an effort to reduce medical injuries. These costs are passed along to the patient and, as a result, standard of care guidelines can increase medical care costs, in contrast with appropriateness guidelines, which are meant to reduce rates of inappropriate procedures arid so reduce overall health care costs. This underlines a critical element of the standard of care guidelines that they will often call for increased expenditures of one sort or another. Indeed, this issue has bedeviled the Risk Management Foundation's efforts to produce guidelines for obstetric care. Initial investigations suggested that continuous physician attendance at labor might have increased safety, but this would have required a commitment of resources that was too costly for teaching hospitals. Thus, standard of care guidelines have to involve a careful calculation of the tra~le-off between safety aloud cost, which perhaps explains why more insurance companies have not gotten involved in guidelines development. 60f course, compliance with guidelines has been one of the great problems noted thus far. See Robert Grilli et al., The Impact of Practice Management Guidelines on the Care of Breast, Colorectal and Ovarian Cancer. Medical Care 29:50-67, 1991. 7See Frederick W. Cheney, Karen Posner, Robert A. Caplan and Richard J. Wort, Standard of Care in Anesthesiology Liability. Journal of tile American Medical Association 261: 1599-1605, 1989.

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106 SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES Although there are anecdotal reports of guidelines use by other malpractice insurers, it appears that, among physician insurers, only two companies are seriously engaged in authorship of guidelines: the COPIC Insurance Company in Colorado and the Utah Medical Insurance Association.8 COPIC has publicized its efforts and continues to promulgate new guidelines.9 Using a database of 10,000 closed medical liability claims, COPIC identified its high-risk areas. These included informed consent, altered medical records, anesthesiology monitoring, obstetrics, and diagnosis of breast cancer. Advisory committees were formed in each of these areas, consisting of COPIC-insured practicing physicians and defense attorneys. The committees proposed guidelines for safer patient care management. Once the guidelines were accepted by the board of the insurance company, theywere incorporated into a Participatory Risk Management Program (PRMP). Under the PRMP, any physician wishing to purchase insurance from COPIC is asked to sign a written agreement that he or she will comply with guidelines to the extent feasible in a given clinical situation. To date no physician has refused to sign the agreement. COPIC attributes decreases in anesthesiology and obstetrics malpractice premiums to the PRMP. In addition, compliance with the guidelines is now incorporated into an experience rating system that helps define the amount physicians will pay for premiums. This aggressive policy is being carefully followed by the rest of the professional liability insurance industry. The other major development in risk management and guidelines is the Risk Management Foundation's newest initiative in loss control. Reviewing claims files, the RMF loss control staff has identified certain areas of concern. Working with the insured institutions and health services researchers at the Harvard School of Public Health, the foundation has provided significant funds for the study of the quality of care in these areas. The first such project, the Harvard Emergency Department Quality Study, has focused on emergency department care. In addition to development of certain minimal clinical criteria (defined as parameters of care for common diagnoses), the research has involved use of health status measurement, patient satisfaction and problem score surveys, arid record review. An initial study of 5,000 patient encounters has demonstrated broad deficiencies in the care rendered to emergency department patients and has allowed insured institutions to benchmark their care against one another.~ Following the initial data collection Personal communication from Lawrence Smarr, Executive Director, Physician Insurance Association of America, July 7, 1994. 9See George O. Thomasson, Participatory Risk Management: Promoting Physician Compliance in Practice Guidelines. Journal on Quality Improvement 20:317-329, 1994. Resee Harvard Emergency Department Quality Study Investigators, The Quality of Emergency Department Care. Phase One, January 15, 1994.

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APPENDIX C 107 and analysis, the Foundation is now supporting quality improvement efforts at each of the institutions with an eye to reassessing emergency department care once the quality improvement efforts are put into place. This combination of health services research and continuous quality improvement methodologies is exciting. Central to the Harvard Emergency Department Quality Study has been the creation of minimal clinical criteria. They were the product of consensus sessions conducted by the emergency department chiefs at the Harvard hospitals, followed by modified Delphi technique validation by nationwide experts. The criteria were then converted into explicit data collection instruments. Record review using these instruments has demonstrated compliance with these minimal clinical criteria has ranged hom 30 to 75 percent. In light of this surprisingly poor performance, the emergency department directors are now planning new medical record forms that will force individual clinicians to consider and document minimal clinical criteria in appropriate cases. It is thought that this will reduce misdiagnoses in emergency departments and also provide better documentation in cases in which claims are brought. This is yet another example of an insurer enforcing compliance with guidelines. GUIDELINES AND MALPRACTICE LITIGATION: LEGISLATIVE EFFORTS While COPIC and RMF guidelines are intended to decrease malpractice litigation by decreasing the rates of injuries, it is important to note that guidelines are a two-way street. Guidelines promulgated by malpractice insurers, or any other entities, can be used by either a defendant or a plaintiff to define the standard of care. In Colorado in 1992, a malpractice plaintiff brought a claim against a COPIC-insured physician and alleged that the defendant had failed to follow the PRMP guidelines for breast cancer diagnosis. The State Supreme Court upheld a decision by the trial court that the guidelines could not be admitted as evidence." The court recognized that the promotion of guidelines by insurance companies would have an overall safety-inducing effect and wished to avoid chilling that initiative by allowing the guideline to be used against the malpractice insurer. lessee Virginia Quigley and James Quigley vs. William Jobe, M.D., Supreme Court, State of Colorado, Denver Case No. 93 S.E. 47, 1993.

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108 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES The decision was atypical. In most situations, guidelines have been freely admissible in courts of law. Indeed, both review of litigation records and surveying of attorneys reveals that guidelines are more likely to be used for inculpatory purposes (that is, demonstrating that a defendant failed to comply with the standard of care) than they are for exculpatory purposes. This is not surprising. If in a specific situation a guideline favors the defendant, and the plaintiff s attorney is aware of the guideline, it is very unlikely that any case will be brought. On the other hand, a guideline that shows a failure to meet a standard is an extremely inexpensive demonstration of the standard of care and hence very valuable to the plaintiff's attorney. Thus we would expect guidelines to be used widely by plaintiffs. Medical malpractice liability insurers who are interested in promulgation of guidelines will have to be prepared for the occasional case based on their own guidelines, and for the frequent use of other guidelines by plaintiffs. States have been quite aware of the relationship between guidelines and malpractice litigation. Led by the state of Maine, and now closely followed by Minnesota and Vermont, legislatures have incorporated practice guidelines into tort reform.~3 The Maine Medical Liability Demonstration Project is a five-year experiment to understand the relationship between practice parameters and medical liability. In Maine, four specialties (emergency medicine, anesthesiology, obstetrics/gynecology, arid radiology) have been allowed to endorse certain guidelines for malpractice purposes. Any physician who follows these guidelines can use them as exculpatory evidence if sued. The precise procedural impact of the so-called "affirmative defense" has not become clear, largely because no cases have been brought against physicians complying with the guidelines. It appears the compliance with the guidelines would be considered by the prelitigation claims screening panel that occurs in Maine, but this would not prohibit the plaintiff from going to trial. Much more draconian from the point of view of litigant's rights is the Minnesota statute that suggests that compliance with the guideline would be per se exculpatory evidence, thereby ending litigation once a panel determines a physician has complied with the guideline. These sorts of reforms are being actively studied by a number of other states and have become part of the standard tort reform package of the 1990s. Thor a general discussion see Andrew L. Hyams, et al., Malpractice Litigation and Practice Guidelines, Report to the Physician Payment Review Commission, January 1994. Resee generally, Hyams, supra note 11. On Maine in particular see Gordon H. Smith, A Case Study in Progress: Practice Guidelines in the Affirmative Defense in Maine. Journal on Quality Improvement 19:355-368, 1993 ..

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APPENDIX C 109 Congressional architects of malpractice reform have also become very excited about guidelines. The Clinton Health Security Act, as well as proposals from Senator Chafee, Representative Cooper, and the conservative Republican proposals all contain provisions that would allow or encourage use of practice guidelines in malpractice litigation. The Clinton Administration has proposed experimentation with the use of guidelines, but others are quite willing to move forward with direct exculpatory use. Both state and federal reformers overlook the fact that practice guidelines and malpractice litigation are a two-way street, as outlined above. Existing legislative proposals endorse guidelines solely for exculpatory purposes. From a quality perspective, the use of practice guidelines in malpractice litigation is most efficient if both plaintiffs and defendants are accorded equal procedural footing. If failure to comply with a guideline were to be per se evidence of negligence, thus ensuring a successful suit by a plaintiff, insurance companies will have great interest in bringing about compliance with those guidelines. If there is an ultimate bar to litigation should the physician follow the guideline, the compliance is doubly enforced. This should be quite clear to reformers, but in their efforts to please providers and insurers both state and federal representatives have ignored the importance of symmetry in the use of guidelines in malpractice litigation. They have also tended to overlook the problem of dueling guidelines. In some critical situations, such as the diagnosis of breast cancer, plaintiffs and defendants are able to take advantage of guidelines that conflict with one another. The differences between the Public Health Service and the National Cancer Institute ma~nmogra~n recommendations provide both plaintiffs and defendants with ample ammunition in a failure to diagnose case. Existing legislation does not provide much direction for courts in these situations. Thus, existing legislative proposals regarding the use of guidelines in malpractice litigation are relatively crude. More careful consideration ofthe role of guidelines as exculpatory and inculpatory evidence, and of the limits of such evidence, will have to be undertaken in the future. SUMMARY Malpractice litigation can provide a basis for determining priorities for development of guidelines that set a standard of care. Some insurers are already talking this step and have gone so far as to require physicians to comply with guidelines. As databases on claims grow and are snore systematically analyzed by insurers, the potential for guidelines promulgation will only increase. Hence, malpractice litigation should be seen as a valuable source of information for priority setting.

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110 SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES ~ a somewhat separate issue, malpractice insurers will have to be prepared to incorporate guidelines into their defense of some cases and counter the use of guidelines by plaintiff's attorneys in other cases. Every indication is that the use of practice guidelines in malpractice litigation will continue to grow. Hence, even if they are not in the business of promulgating guidelines, malpractice insurers will become much more aware of and familiar with the nature of guideline-based evidence.