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The protocol solution: a mildly acidic commentary.

Protocols(*1) have captured the imagination of American's health care guru's. These self-proclaimed experts promise decreases in health care expenses of up to 25 percent if protocols for the appropriate use of expensive procedures are adopted throughout the country. With the establishment of several proprietary protocol companies and the push to develop national clinical guidelines, protocols have appeared on the health care scene with a vengeance. However, protocols will have dramatically different effects, depending on how and where they are implemented. This article will concentrate on the challenges of implementing protocols in a single health care institution, typically a hospital or a managed care institution.

Medical directors, hospital administrators, and members of boards of trustees should view protocols as an important tool in the effort to improve the quality

and lower the cost of care. This is particularly true if protocols are implemented as an integral part of a continuous quality improvement (CQI) or total quality management (TQM) program. At the same time, contrary to what many pundits believe:

* On a nationwide basis, protocols will at most decrease health care expenses by 5 percent.

* Nationally developed protocols or guidelines may have minimal clinical impact.

* Cost savings derived from the use of protocols will largely come from locally developed protocols.

A protocol cannot be seen in a vacuum; it is the context in which it is implemented that is critical. From a national or societal perspective, it is entirely possible that uniform application of a protocol for appropriate use of, for example, mammograms or even CABGs could result in higher, not lower, total health care expenses. Numerous research articles have demonstrated that large numbers of individuals, particularly those without adequate health insurance coverage, receive far fewer procedures than comparable individuals who are adequately insured. While this reflects, in part, inappropriate procedures provided to insured individuals, there is ample reason to believe that underinsured individuals are not receiving adequate services. This large pool of underservice represents one of the flies in the ointment for those pundits proclaiming that mere application of protocols for CABGs will result in major reductions in national health expenditures. That may be true if the protocols are ap-plied only to individuals with adequate health insurance. It certainly is not true if applied to all American citizens regardless of their insurance coverage.

The other problem with protocol-related reductions in costs is that it is unclear whether use of protocols will result in temporary or permanent avoidance of a CABG. While studies claim that approximately 20 percent of CABGs are performed unnecessarily, there are no studies that document that these same patients will not need the CABG within, for example, five years. While this is a critical unanswered question for hospital medical directors and primary care physicians, it may be less important for utilization review companies that are paid on the basis of avoiding a CABG at a specific time.

Physician executives need to bear in mind several key issues in the effective implementation of protocols. From an organizational point of view, protocols should be integrated into the continuous quality improvement process. It is unlikely that protocols will achieve any lasting impact if medical directors and hospital administrators view them purely as a tool to increase DRG revenues. Rather, protocols should provide a snapshot of a process of care that needs improvement.

Another important CQI tenet relevant to protocols is that protocols should be developed for the clinical and nonclinical aspects of the issue under review. Figure 1, below, illustrates a protocol summarizing the process of administration and clinical care pertaining to a portion of the mammogram delivery process. In contrast, figure 2, right, summarizes a protocol pertaining to the clinical aspects of appropriate use of coronary artery bypass grafts. A protocol written in the format of figure 2 can be easily programmed into an artificial intelligence software package.

A corollary of using protocols within the CQI framework is that protocols should be locally developed. There is currently a national debate over who should develop purely clinical protocols. Should they be nationally or locally derived standards? Who should be involved in their formulation? Should only physicians be involved or do patients have a role? While protocols should be developed locally, they should be completed with input from the empirical, research-based literature, which represents a de facto national standard. This de facto national standard should be in the form of a guideline. The protocol development process should not be made too complex.

What types of clinical processes merit the development of protocols?

* Procedures that can result in significant harm to patients, such as CABGs.

* Expensive procedures, such as organ transplantation, or complex diagnostic work-ups.

* Procedures or diagnostic work-ups for which significant overuse has been documented, such as back surgery or cesarean sections. It is important to note that inappropriate use is generally the result of uncertainty in the scientific literature as to the precise utility of an intervention.

What should be the role of the patient in the protocol development process? In recognition of CQI's resolute customer emphasis, the patient, as the ultimate customer, should be involved in the development and implementation of clinical protocols. Involving patients has the potential of not only improving the process of care but also constituting an excellent marketing device for the hospital or managed care organization. Patients could be involved in all phases of protocol development, ranging from selection of the clinical process to be studied to actual implementation of the protocol. Their role may be particularly useful in the implementation phase. If there is a great deal of controversy surrounding appropriate use of a procedure, such as the use of prostate surgery for benign prostate enlargement, patients should play a critical role in deciding whether or not to have the procedure. However, they can perform this role only if they have all the facts. What better way to participate in this decision-making process than to have a clearly outlined protocol for prostate surgery that is described in lay terms.

The role of the patient in protocol development and implementation raises legal issues. Will the use of protocols assist or accelerate the malpractice "crisis" already affecting American medicine? Recently, the Maine Medical Society decided to use protocols developed on a statewide basis in the defense of physicians accused of malpractice. They have decided, for the present, not to use these protocols against physicians who might not have provided care in accordance with them. It is unclear how protocols in general and the specific application adopted by the Maine Medical Society will operate in practice. However, if one looks at the research data, which indicate that only a fraction of compensable events are ever filed, it appears unlikely that protocols will have any dramatic effect on total monetary damages. It is possible that publicly available protocols may very well have a salutary effect on at least the most egregious examples of malpractice. This, however, will occur only if the state medical societies are able to bite the bullet and discipline physicians who practice medicine that violates even the most lenient of clinical protocols. This is another example of how protocols will not have any impact on their own. They need to be seen as part of an overall attempt to improve the process of care.

We are at the precipice of a new age of medical practice. Major changes in American medicine will occur, particularly if clinical and administrative protocols are integrated into a better understanding of the entire process of care. In the final analysis, the precise impact of protocols remains unclear. A critical unanswered research question is whether or not implementation of a protocol merely postpones rather than completely avoids, for example, the coronary artery bypass graft (CABG). Perhaps the uncertain impact of protocols is appropriate. In an age of reliance on statistical analysis and the scientific method, it is worth remembering that medicine is still an art. While we will continually attempt to improve the scientific basis in the process of medicine, the bottom line remains the individual interaction between the doctor and patient.

(*1) It is important to define terms that are bandied about. Protocols, algorithms, and critical maps all share the following characteristics:

* A diagrammatic structure with branching logic describing all-or-nothing choices for the provision of care.

* Sequential logic relating specific findings to appropriate actions.

* Clear endpoints, each with a recommendation for action by health professionals.

Protocols must be distinguished from practice guidelines and parameters. A guideline is a discursive, nondiagrammatic protocol. Protocols are one form of guidelines. However, not all guidelines are protocols. Practice parameters may be expressed in the form of protocols, but they may also be discursive.
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Title Annotation:Medical Quality Management
Author:Goldfield, Norbert
Publication:Physician Executive
Date:Nov 1, 1992
Previous Article:Developing integrated delivery systems: an era of change in hospital-physician relationships.
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