CHAPTER 37

GUIDELINES AND INDIVIDUAL PATIENTS

Steven Shea, M.D.

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            Early efforts to assure the quality of medical care focused on credentialing: where a physician went to medical school or trained on the housestaff, whether the physician is board eligible and board certified, or whether there have been malpractice suits. The Joint Commission on Accreditation of Hospital Organizations (JCAHO) still focuses on credentialing in its assessment of hospital compliance with its standards. Over the last twenty years, work in the area of quality assurance has shifted emphasis to the measurement of outcomes and indicators of the process of care.

While theoretical debates continue between the advocates of outcomes and the advocates of process indicators, in reality both are widely used. Examples of clinical outcomes include: complications, perioperative mortality, hospital readmission, and six or twelve month mortality. Examples of patient-oriented outcomes include: general health and well being, functional status, and satisfaction with care. Process indicators refer to documentation of specific aspects of care such as, for example, immunizations, screening tests, follow-up visits for hypertension or diabetes, HIV screening and counseling, or prenatal care. Each of these quality measures has its own strengths and weaknesses. Clinical outcomes are generally specific to a medical condition or treatment. For example, rates of major hemorrhage among anticoagulated patients or major operative complications following cholecystectomy are specific to those treatments. Patient-oriented outcomes, on the other hand, are nonspecific and apply to all patients regardless of medical condition and regardless of whether the patient is relatively sick or healthy. This allows comparison of outcomes of management strategies across multiple conditions and across inhomogeneous groups of patients using methods like cost-effectiveness analysis. Both kinds of outcomes have the limitation that it is difficult to apply these measures to the care of an individual patient, since factors that are part of the patient’s condition, as well as factors related to the care of the patient contribute to outcome. Process indicators, on the other hand, represent a standard of care that can be applied to individual patients. The limitation of process indicators is that these measures do not address whether delivering care to a certain standard improves the patient’s condition, reduces adverse medical outcomes, or gives good value for the resources expended.

            The assessment of the effects of management strategies on clinical or patient-oriented outcomes is probably best done through randomized clinical trials and meta-analyses. Assessment of the quality of the care process has traditionally been done retrospectively, for example, in complication rounds in departments of surgery and in morbidity and mortality rounds in the Department of Medicine, where cases with bad outcomes are reviewed retrospectively for clues regarding what in the process of care might have been done differently. This is also the approach followed by the Health Care Financing Administration (HCFA) Peer Review Organizations (PROs) that review the charts of Medicare patients with adverse outcomes. Where evidence of substandard care is found, those responsible may be disciplined or given the opportunity to document that changes have been made to prevent recurrence, or both. The focus of this approach to quality assurance is on individuals and on the relatively small subset of “bad apples.” In this model, the relationship between those monitoring quality of care and health care providers is often adversarial and punitive.

            In the last few years, new paradigms regarding quality of care have disseminated from industrial manufacturing process control into the medical domain. These new ideas have been termed total quality management (TQM) or continuous quality improvement (CQI).[i]^-3 Here the focus is on the process of care, rather than on individuals, and on the large number of providers and episodes where care can be improved incrementally. The relationship between quality management activities and providers is non-adversarial, collegial, and helpful. Most important, quality management occurs at the time of the clinical episode, so that the quality of the care provided in the episode can be improved, rather than retrospectively, after the episode, when it is too late to do anything other than censure the provider. The attractiveness of this model is intuitive, its effectiveness has been demonstrated in private industry, and its mathematical and theoretical basis is sound.²

            The major obstacle to implementing the “continuous quality improvement” model in health care has not been the lack of care standards or the inability to measure quality - both have had very substantial development over the last two decades - but the inability to provide real-time assistance to the providers. It is clearly envisioned that as clinical computing systems develop over the next decade to include computer-based order entry and sophisticated decision support programs, computer-based guidelines may become a practical cost-effective reality.

            Forces behind these developments include the concerns of patients and consumers, purchasers of care, and regulatory and government agencies. The governmental and private purchasers of care for large numbers of patients, either as insurers or as purchasers of managed care contracts, have grown increasingly interested in measuring the quality of the care purchased. The issue of how health care providers can meet these challenges has been at the center of the development of clinical guidelines and care plans.

            Practice guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”⁴ While there is some inconsistency in the use of the term, by guidelines we mean lists of criteria that define the appropriate use of diagnostic tests or therapeutic interventions. Examples would be lists of indications for coronary artery bypass surgery, colonoscopy, or mammography. Care plans, sometimes also termed critical pathways or protocols, describe the inputs to an episode of care, the timetable on which these inputs should occur, and who is responsible for each input. Examples would be the critical pathway currently in use at CPMC for routine coronary artery bypass surgery or the protocols for the management of hypertension and hyperlipidemia widely used in managed care settings.

            The challenge posed by the application of guidelines and care plans to individual patients and clinical situations is that generalizations rarely fit individuals precisely. The conceptual problem is similar to applying clinical trial data, which represent findings for groups of patients, to the individual in the office. There will always be exceptions and adjustments, and good clinical medicine requires judgment regarding whether a guideline applies and how to apply it. Clinical decisions remain the responsibility of the physician. Guidelines should be viewed as clinical tools, not as substitutes for judgment or compassion. Despite the evolving corporate ethos of medicine, the physician’s responsibility is first to his or her patient, and the practicing physician remains personally accountable.

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