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Broadcasting Clinical Guidelines on the Internet: Will Physicians Tune In?
Published online by Cambridge University Press: 24 February 2021
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Modern American medicine is far from ideal. Physicians practice by rules learned in medical school, rules often based on anecdotes or untested hypotheses. Medical opinion leaders shape practice by their own experience even though anecdotes are no substitute for clinical studies. Pressures to diagnose and treat come from pharmaceutical companies, equipment manufacturers, hospitals and managed care organizations (MCOs). The end result is often too much medicine or too little, but rarely the appropriate amount. Patients can end up suffering iatrogenic effects of infections picked up during hospital stays, complications from surgery or drug side effects or “cascade effects” that occur when several interventions fail in succession.
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References
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51 See Stephen B. Soumerai et al., Improving Drug Prescribing in Primary Care: A Critical Analysis of the Experimental Literature, 67 MlLbank Q. 268, 269 (1989).
52 See id.
53 See id.
54 See l President'S Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions: A report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship 121 (1982) (stating “drugs are the most common treatment in all medical care. Most visits to the doctor result in a prescription being written … .”); see also Steven A. Wartman et al., Do Prescriptions Adversely Affect Doctor-Patient Interactions?, 71 AM. J. Pub, Health 1358, 1358 (1981) (prescriptions as a therapeutic action have become expected as result of the medical care visit); Jan Koch-Weser, Fatal Reactions to Drug Therapy, 291 New Eng. J. Med. 302, 303 (1974) (discussing adverse drug effects commonly due to inappropriate pharmacology).
55 See Soumerai et al., supra note 51, at 270-71; see also Robert S. Mendelsohn, Mal(E) Practice: How Doctors Manipulate Women 36-37 (1981) (arguing that oral contraceptives have been prescribed as if they are no more hazardous than chewing gum).
56 See Furrow, supra note 50, at 378-79.
57 See Soumerai et al., supra note 51, at 269-70.
58 See id. at 270.
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61 See generally David A. Kessler et al., Therapeutic Class Wars—Drug Promotion in a Competitive Marketplace, 331 New Eng. J. Med. 1350,1351 (1994) (explaining that seeding trials involve company-sponsored trials of approved drugs with little scientific purpose).
62 See Soumerai et al., supra note 51, at 269-70.
63 See, e.g., Barak Gaster, The Learning Curve, 270 Jama 1280 (1993) (telling the story of older surgeons' struggles to keep up with innovative surgery techniques).
64 See Chassin, supra note 59, at 574.
65 See id. at 576.
66 Id.
67 See id.
68 See Barry R. Furrow, Regulating the Managed Care Revolution: Private Accreditation and a New System of Ethos, 43 VlLl. L. Rev. 363, 371 (1998).
69 See Lawrence E. Singer, The Conversion Conundrum: The State and Federal Response to Hospitals' Changes in Charitable Status, 23 Am. J.L. & Med. 221, 221-22 & n.4 (explaining that “[t]he largest internal capital expense of hospitals is management information systems and related bedside information technology”).
70 See Terry Ken, Here's What's Coming—Like it or Not: Doctors' Reluctance to Follow disease Management Guidelines, Med. Econ. Apr. 27, 1998, at 72.
71 See Goldberg, Harold I. et al., A Randomized Controlled Trial of CQI Teams and Academic Detailing: Can They Alter Compliance with Guidelines?, 24 J. Quality Improvement 130, 140 (1998)Google Scholar.
72 See Leahy, Richard E., Comment, Rational Health Policy and the Legal Standard of Care: A Call for Judicial Deference to Medical Practice Guidelines, 77 Cal. L. Rev. 1483, 1484 (1989)Google Scholar.
73 See Paul J. Edelson, Clinical Practice Guidelines: A Historical Perspective on Their Origins and Significance, in Getting Doctors to Listen: Ethics and Outcomes Data in Context 31,31 35 (Philip J. Boyle, ed. 1998).
74 See generally Furrow, supra note 68, at 400.
The National Committee for Quality Assurance (NCQA) is an independent, nonprofit standard-setting organization that surveys and accredits managed care organizations [MCOs]; it also develops performance standards for health plan report cards. Accreditation is an indication that an MCO is committed to principles of quality and is continuously improving the clinical care and services provided. NCQA reviews how a plan manages its delivery system of physicians, hospitals and other providers. Its performance measures look at specific indicators of quality. It has become the leading source of quality information on MCOs.
Id.
NCQA has reviewed over 300 of the nation's health maintenance organizations (HMOs). Several states, including Florida, Kansas, Oklahoma, Pennsylvania and Rhode Island, allow MCOs to use accreditation from either NCQA or the Joint Commission for Accreditation of Healthcare Organizations to substitute for review by state regulators. See id. at 400 n.208.
75 Legal analyses of clinical practice guidelines have proliferated as their importance has increased. See, e.g., John Ayres, The Use and Abuse of Medical Practice Guidelines, 15 J. Legal Med. 421, 436-38 (1994) (using economic factors to develop guidelines); Office of Technology Assessment, United States Congress, Ota-H-608, Identifying Health Technologies That Work: Searching for Evidence 145-47 (1994) (citing guidelines developed by various organizations in differing conditions); Edward Hirshfeld, Use of Practice Parameters as Standards of Care and in Health Care Reform: A View from the American Medical Association, 19 J. on Quality Improvement 322, 323 (1993) (discussing practice guidelines as mandatory standards of care); Troyen A. Brennan, Practice Guidelines and Malpractice Litigation: Collision or Cohesion?, 16 J. Health Pol., Pol'Y & L. 67, 67 (1991) (stating that guidelines should reflect the negligence standard, desired outcomes and technological changes); Mark A. Hall, The Defensive Effect of Medical Practice Policies in Malpractice Litigation, 54 Law & Contemp. Probs. 119, 120 (1991) (using cost-sensitive medical practice policies to address spending and malpractice crises); Clark C. Havighurst, Practice Guidelines as Legal Standards Governing Physician Liability, 54 Law & Contemp. Probs. 87, 113 (1991) [hereinafter Havighurst, Legal Standards] (differentiating practice parameters from practice guidelines); Edward Hirshfeld, Should Practice Parameters Be the Standard of Care in Malpractice Litigation?, 266 Jama 2886, 2887 (1991) (stating that guidelines should be designed as policies that reflect social and medical diversity and technical problems); David M. Eddy, Clinical Decision Making: From Theory to Practice (Parts 1-4), 263 Jama 287, 441, 877, 1265 (1990); Clark C. Havighurst, Practice Guidelines for Medical Care: The Policy Rationale , 34 St. Louis U.L.J. 777, 777 (1990) [hereinafter Havighurst, Medical Care] (stating various guidelines serve various social and economic values); Maxwell J. Mehlman, Assuring the Quality of Medical Care: The Impact of Outcome Measurement and Practice Standards, 18 L., Med. & Health Care 368, 375 (1990) (describing practice standards from experts and data in the scientific literature); Eleanor D. Kinney & Marilyn M. Wilder, Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities, 22 U.C. Davis L. Rev. 421, 448 (1989); Leahy, supra note 72, at 1506-08, 1522-27; William L. Roper et al., Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice, 319 New Eng. J. Med. 1197, 1198 (1988) (discussing data on practice variations and outcome from the Health Care Financing Administration); Chassin et al., supra note 24, at 287 (discussing practice variations); John E. Wennberg et al., Professional Uncertainty and the Problem of Supplier-Induced Demand, 16 Soc. Sci. Med. 811, 812-17 (1982) (discussing policies for practice variation).
76 Eddy, David M., Guidelines for Policy Statements: The Explicit Approach, 263 Jama 2239, 2239(1990)CrossRefGoogle Scholar. He continues:
Many policies are created by individuals or organizations that have narrower or different perspectives than the people who will eventually have to implement the policy. For example, the government might design a policy with an eye toward cost control; investigators might let their enthusiasm for an intervention spill over into a premature or inappropriately aggressive policy; specialists might forget that their selective practices distort the apparent frequencies of diseases and outcomes; organizations that focus on single diseases might try to load practitioners with policies that are unrealistic in a busy general practice; one specialty society might write a policy that restricts the role of another specialty.
Id.
77 See Steven H. Woolf, Practice Guidelines: A New Reality in Medicine, 153 Archives Internal Med. 2646, 2647 (1993).
78 See Lucian L. Leape, Error In Medicine, 272 Jama 1851, 1851 (1994) (noting studies showing that errors in the health care system are present, but preventable).
79 Lucian L. Leape et al., Systems Analysis of Adverse Drug Events, 274 Jama 35, 35 (1995).
80 See James P. Murray et al., Ambulatory Testing for Capitation and Fee-for-Service Patients in the Same Practice Setting: Relationship to Outcomes, 30 Med. Care 252, 252 (1992) (A study of a group of physicians who provided care for hypertensive patients with either capitation or fee-for-service health insurance plans revealed that “patients with capitation health insurance had fewer laboratory tests and lower overall charges than the fee-for-service patients, with no clinical or statistically significant differences in one-year health outcomes.” Id.); see also Barbara Starfield et al., Costs vs. Quality in Different Types of Primary Care Settings, 272 Jama 1903, 1903 (1994) (studying the relationship between efficiency in the use of resources and quality of care provided by physicians in a state Medicaid program. The authors found a general lack of relationship between quality and costs. “Facilities that provide services at lower costs can achieve adequate quality as often as higher-cost facilities.” Id. at 1907).
81 See Kate T. Christensen, Ethically Important Distinctions Among Managed Care Organizations, 23 J.L., Med. & Ethics 223, 225 (1995); Ezekiel J. Emanuel, Managed Competition and the Patient-Physician Relationship, 329 New Eng. J. Med. 879, 880 (1993); Emily Friedman, Changing the System: Implications for Physicians, 269 Jama 2437, 2442 (1993). Critics view managed care as an industry-spawned development that increases “surveillance and control over many parts of the health care delivery system.” Betty Leyerle, the Private Regulation of American Health Care 9 (1994). Betty Leyerle sees these developments in health care as one example of the “encroachment of bureaucratic organization into almost every area of our lives … . Bureaucracy, today, is the mechanism through which an increasingly total kind of social control can be exercised.” Id. at ix.
82 See Mark A. Hall, Rationing Health Care at the Bedside, 69 N.Y.U.L. Rev. 693, 705 (1994); Wennberg, supra note 2, at 2568.
83 See Leape, supra note 78, at 1851. Examples include patients who are overdosed, infected in the hospital, suffer surgical accidents and even die from medical accidents. See id. at 1855 (stating that faulty systems design is the major source of errors).
84 See Leape et al., supra note 79, at 35.
85 See Brook & Lohr, supra note 3, at 74.
86 See id. (describing federal policy programs that might be implemented to improve quality of care and save money).
87 See Peter J. Greco & John M. Eisenberg, Changing Physicians' Practices, 329 New Eng. J. Med. 1271, 1271 (1993).
88 See id. (noting how “remarkably unsuccessful” guidelines have been in influencing physicians).
89 See generally Frankford, supra note 32, at 104 (concluding that financial incentives will likely result in increased conflict rather than greater control over medical clinicians' work). For a general discussion of different kinds of guidelines, see William R. Trail & Brad A. Allen, Government Created Medical Practice Guidelines: The Opening of Pandora's Box, 10 J.L. & Health 231 (1995-96).
90 See Leyerle, supra note 81, at 169.
91 See Arnold J. Rosoff, The Role of Clinical Practice Guidelines in Health Care Reform, 5 Health Matrix 369, 375 (1995).
92 See Greco & Eisenberg, supra note 87, at 1271 (explaining why practice guidelines have been influential).
93 See, e.g., Barry R. Furrow, Setting Limits in the Dying Zone: Assisted Suicide, Scarce Resources, and Hard Cases, 72 U. Det. Mercy L. Rev. 901, 923 (discussing the mixed incentives of nursing homes and patients in euthanasia cases).
94 See, e.g., Jonathan Lomas et al., Opinion Leaders vs. Audit and Feedback to Implement Practice Guidelines: Delivery After Previous Cesarean Section, 265 Jama 2202 (1991) (evaluating physicians' implementation of clinical practice guidelines recommending vaginal births over cesarean sections).
95 Deborah W. Garnick et al., Can Practice Guidelines Reduce the Number and Cost of Malpractice Claims?, 266 Jama 2856, 2857 (1991).
96 See Rosoff, supra note 91, at 384.
97 In 1985, David Covell, Gwen Uman and Phil Manning published the results of a study analyzing the information needs of forty-seven physicians during a half-day of typical office practice. David G. Covell et al., Information Needs in Office Practice: Are They Being Met?, 103 Annals Internal Med. 596 (1985). Physicians raised 269 questions during a series of 409 patient visits. Id. at 596. The study found that these physicians actually formulated about two questions for every three patients seen, with most of the questions related to treatment of specific conditions, diagnosis of symptoms, physical findings or drug information. Id. Yet physicians found answers only thirty percent of the time! Id. at 598. Physicians cited lack of time to look up information, a glut of information sources and poor organization as significant barriers to obtaining answers to questions in the medical literature. Id. See also Jeremy Wyatt, Use and Sources of Medical Knowledge, 338 Lancet 1368, 1368 (1991) (discussing the rate of journal growth as a source of search and access problems).
98 See Covell et al., supra note 97, at 596.
99 See id.
100 See John W. Williamson et al., Health Science Information Management and the Continuing Education of Physicians, 110 Annals Internal Med. 151 (1989). John Williamson et al. found that over one-third of the specialists surveyed were entirely unaware of the medical value of glycosylated hemoglobin used in the assessment of diabetics, and about half were ignorant of the risks of digitalis withdrawal in elderly patients with uncomplicated heart failure. See id. at 153.
101 See C. Edward Evans et al., Does a Mailed Continuing Education Package Improve Physician Performance? Results of a Randomized Trial, 255 Jama 501 (1986).
102 See generally Covell et al., supra note 97, at 599 (finding that physicians “want and need” information to answer questions arising in office practice).
103 See Greer, Ann Lennarson, The Slate of the Art Versus the State of the Science, 4 Int'L J. Tech. Assessment Health Care 5, 23 (1988)CrossRefGoogle Scholar (discussing causes of slow technology diffusion from external sources into local medical behavior).
104 See R. Brian Haynes et al., How to Keep Up with the Medical Literature: Iv. Using the Literature to Solve Clinical Problems, 105 Annals Internal Med. 636, 638 (1986).
105 See Roberto Grilli & Jonathan Lomas, Evaluating the Message: The Relationship Between Compliance Rate and the Subject of a Practice Guideline, 32 Med. Care 202, 210 (1994).
106 See id. at 210.
107 See id.
108 Researchers and providers are sensitive to this criticism and have worked on methodologies to make generic guidelines specific to the needs of particular organizations. See Douglas B. Fridsma et al., Making Generic Guideline Site-Specific (last modified Nov. 21, 1997) <http://camis.stanford.edu/projects/protege/Rapit/Generic.html>. Douglas Fridsma et al. created a prototype system, Camino, to assist guideline developers to make site-specific guidelines from generic guidelines and to use such a system to integrate into a workflow tool to manage medical tasks. See id. Camino annotates a generic guideline with intentions, relative costs and utilities, and then matches these activities to site model activities. See id.
109 See Furrow, supra note 50, at 379.
110 See A. Gray Ellrodt et al., Measuring and Improving Physician Compliance With Clinical Practice Guidelines: A Controlled Interventional Trial, 122 Annals Internal Med. 277, 277 (1995) (suggesting that clinical practice guidelines should complement rather than substitute for physician judgment); J.B. Brown et al., The Paradox of Guideline Implementation: How Ahcpr 's Depression Guideline Was Adapted at Kaiser Permanente Northwest Region, 21 J. On Quality Improvement 5, 6 (1995) (suggesting that tailoring guidelines to local communities may be critical to successful guideline implementation).
111 See George P. Browman et al., The Practice Guidelines Development Cycle: A Conceptual Too! for Practice Guidelines Development and Implementation, 13 J. Clinical Oncology 502, 502 (1995) (developing a Practice Guidelines Development Cycle building on physician consensus and the sociocultural nature of clinical practice and experience.); Isabelle Ray-Coquard et al., Impact of a Clinical Guidelines Program for Breast and Colon Cancer in a French Cancer Center, 278 Jama 1591, 1591 (1997) (finding that physicians' development of a clinical practice guideline at a comprehensive cancer center produced significantly higher compliance rates over time).
112 See Havighurst, Medical Care, supra note 75, at 777 (stating that “[ujnlike most other health policy notions currently in Washington, the idea of 'practice guidelines' is acceptable to all the relevant interest groups.”); see also Havighurst, Legal Standards, supra note 75, at 90 (noting that the Ama's encouraging promulgating “practice parameters” may reflect hope by physicians that they “will be able to prevent the collapse of their preferred paradigm of medical care, under which they are held accountable only under norms and standards they themselves develop”).
113 Such rapid improvement is exemplified by advances in computing technology.
114 See Lomas et al., supra note 94, at 2206.
115 See discussion supra Part II.A.
116 See Lomas et al., supra note 94, at 2206.
117 See generally Michael J. Saks, In Search of the “Lawsuit Crisis”, 14 Law, Med. & Health Care 77, 77 (1986) (arguing that evidence of a true litigation crisis in health care is lacking).
118 See Ellrodt et al., supra note 110, at 277 (attributing physician reservations about practice guidelines to fear of misapplication or abuse, and fear of cookbook medicine; attributing physician noncompliance with practice guidelines to attitudes toward the guidelines, limitations of the guidelines themselves, inefficiencies in hospital or health care delivery systems and differences in patients' clinical status).
119 See Rosoff, supra note 91, at 377.
120 See Frakes v. Cardiology Consultants, No. 01-A-01-9702-CV-00069, 1997 WL 536949, at *4 (Tenn. App. Aug. 29, 1997). The Frakes court found a guidelines table admissible as representing the standard of care of the profession, the consensus standard among cardiologists. Id. at *4. The concurring opinion noted that this was a case of first impression and that the court needed to develop a set of standards for evaluating the admissibility of guidelines: “Clinical practice guidelines can materially assist the triers-of-fact in medical malpractice cases. Properly authenticated clinical practice guidelines are relevant to the question of the proper standard of care and should be admitted as substantive evidence if introduced through a witness who can lay a proper foundation.” Id. at *6.
121 See Crane, Mark, Clinical Guidelines: A Malpractice Safety Net?, Med. Econ. Apr. 12, 1999, at 236Google Scholar.
122 For a more detailed discussion of Ncqa accreditation, see generally Furrow, supra note 68.
123 See Charles Marwick, Investment and Accountability Mean Better Care, 280 Jama 1733, 1733 (1998).
124 See Furrow, supra note 68, at 402-03.
125 See Michael L. Millenson, Demanding Medical Excellence: Doctors and Accountability in the Information Age 341 (1997) (quoting an unnamed HMO medical director: “You flunk an NCQA exam, you get a new medical director and a new CEO”).
126 See Marwick, supra note 123 at 1733.
127 See Millenson, supra note 125, at 343.
128 See id.
129 See id. at 343-44.
130 See Millenson, supra note 125, at 345.
131 See id.; see also Thompson, Joseph W. et al., The NCQA's Quality Compass: Evaluating Managed Care in the United States, 17 Health Aff., Jan.-Feb. 1998CrossRefGoogle Scholar, at 152, 152 (summarizing thirteen HEDIS measures that represent NCQA's ongoing analysis of managed care quality).
132 See Marwick, supra note 123, at 1733.
133 See generally National Committee for Quality Assurance, Standards for the Accreditation of Managed Care Organizations (MCOs) (1999).
134 See id.
135 See id.
136 See Thompson, supra note 131, at 157.
137 See Chesanow, supra note 46, at 222; Daniel R. Longo et al., Consumer Reports in Health Care: Do They Make A Difference in Patient Care?, 278 Jama 1579, 1583 (1997).
138 See Longo et al., supra note 137, at 1582-83.
139 See MlLlenson, supra note 125, at 345 (noting that when HEDIS 1.0 appeared in 1991, “most [HMOs] had trouble answering even the simplest HEDIS questions”).
140 See Furrow, supra note 74, at 406.
141 See Kacmar, supra note 19, at 622-23, (explaining that “Medline is the premier [medical] bibliographical database housed at the National Library of Medicine … containing references to over 3700 biomedical journals covering literature from 1966 to the present. [It] contains all citations published in the hardbound medical literature citation resource called Index Medicus and corresponds in part to the International Nursing Index and the Index to Dental Literature. The database contains over 7.8 million citations from medical literature, with 31,000 new citations added each month.” (citations omitted)).
142 See id. at 622-23. Donald Kacmar notes that although Medline's search capabilities are enormous, it only provides citations to and abstracts of the articles. See id. at 623 & n.39. Another service, Medis, is available to physicians to retrieve the full text of articles; however, Medis contains fewer accessible journals than Medline. See id.
143 See id. at 617-19.
144 See Faulkner and Gray Announces Release of 1998 Practice Guidelines CD-ROM (visited May 18, 1999) <http://www.techmall.com/techdocs/NP98050http://www.guideline.gov/4-4.html> [hereinafter Faulkner].
145 National Guideline Clearinghouse (visited May 18, 1999) <http://www.guideline.gov>.
146 See Linda O. Prager, Internet-based Guideline Repository Unveiled, Am. Med. News, Feb. 1, 1999, at 31, available in 1999 WL 10021001; see also Blue Cross & Blue Shield United of Wisconsin, National Institutes of Health Clinical Practice Guidelines (visited Apr. 7, 1999) <http://www.healthnetconnect.net/treat.html>; Canadian Medical Association, Cpg Infobase: Implementing Clinical Practice Guidelines: A Handbook for Practitioners (visited Apr. 7, 1999) <http://www.cma.ca/cpgs/handbook/index.htm>; Fridsma et al., supra note 108; Faulkner, supra note 144; Society of American Gastrointestinal Endoscopic Surgeons, Sages Guidelines, Statements and Other Publications (visited Apr. 7, 1999) <http://www.Sages.org/sg_pub.html>; University of Texas Medical Branch, Clinical Guidelines Development (visited Apr. 7, 1999) <http://www.libsupport.utmb.edu/cpg>.
147 See National Guideline Clearinghouse, supra note 145.
148 See id.
149 See id.
150 See National Guideline Clearinghouse Resources (visited May 18, 1999) <http://www.guideline.gov/STATIC/resources.asp?view=resources>.
151 Various appropriateness tests have been developed to evaluate guidelines. See generally Paul G. Shekelle & David L. Schriger, Evaluating the Use of the Appropriateness Method in the Agency for Health Care Policy and Research Clinical Practice Guideline Development Process, 31 Health Services Res. 453 (1996).
152 See Prager, supra note 146, at 31.
153 See MDConsult (last modified May 18, 1999) <http://www.http://www.mdconsult.com/mdconsult.com> (providing access to medical references, journals and information for subscribers).
154 Interview with Stephanie Manning, Publisher of MDConsult (Mar. 26, 1999) (discussing that in 1998, MDConsult had over 22,000 measurable “hits” by subscribers of practice guidelines alone. Physicians appeared to be logging on between patients in many cases for quick research. Id. Users showed less interest in chat rooms and bulletin boards that require more time to keystroke in opinions and scroll through those of other physicians. Id. MDConsult had 600 practice guidelines online had been viewed in the past year, and the highest use guidelines were those disseminated by the government. Id.) [hereinafter Interview],
155 Id.
156 E-mail from ConsuIt@MDConsult.com, to the author, (1998) (on file with author) (containing a survey summary of these reasons).
157 The Medscape website provides online “e-med texts,” which are essentially medical textbooks, available and interactive on Medscape's website. See Medscape Multispecialty Home Page (visited May 18, 1999) <http://www.http://www.medscape.com/medscape.com>.
158 See id.
159 See E.R. Worth, Recent Developments in Electronic Medical Records, Mo. Med., May 1998, at 207, 207 (explaining that the pieces needed for physician palmtop computer systems are available today).
160 See Prager, supra note 146, at 31.
161 Id.
162 See Lomas et al., supra note 94, at 2206.
163 See id.; Stephen M. Shortell, Physician Involvement in Hospital Decision Making, in The New Health Care for Profit: Doctors and Hospitals in A Competitive Environment 73, 90 (Bradford H. Gray, ed. 1983).
164 See Lomas et al., supra note 94, at 2206.
165 See id.
166 See Shortell, Stephen M. & LoGerfo, James P., Hospital Medical Staff Organization and Quality of Care: Results for Myocardial Infarction and Appendectomy, 19 Med. Care 1041 (1981)Google Scholar.
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