Guidelines for Clinical Practice From Development to Use (1992) / Chapter Skim
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6 THE INESCAPABLE COMPLEXITY OF DECISIONMAKING: ETHICS, COSTS . . .
6 THE INESCAPABLE COMPLEXITY OF DECISIONMAKING: ETHICS, COSTS . . .
Pages 135-162
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From page 135... ...
The discussion then turns to health care costs and the responsibilities of guidelines developers to consider these costs in their recommendations. The last sections of the chapter consider the issue of informed consent and the concept of basic or minimum care.
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From page 136... ...
They will thereby inform but not necessarily dictate answers to ethical or policy questions such as where to draw lines between care that is covered by insurance plans and care that is not. AN ETHICAL CONTEXT Members of the IOM committee brought to the study several ethical concerns about the development, use, and evaluation of clinical practice guidelines.
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From page 137... ...
During the past two decades, patient autonomy has been increasingly emphasized and the paternalistic substitution of professional for patient judgment correspondingly criticized (President's Commission, 1983; Kapp, 1989; Povar, 19911. Single-minded emphasis on autonomy, however, has also been challenged for three reasons.
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From page 138... ...
Ideally, practice guidelines should strengthen the dialogue between patient and physician. They should serve the objective of patient autonomy by being as clear as possible about the evidence and rationale for guideline recommendations, the outcomes expected for alternative courses of care, and the ways patients may view these outcomes.2 For example, guidelines that carefully present evidence about how test results will or will not affect patient management or patient outcomes can help physicians distinguish between a mere "quest for diagnostic certainty" (Kassirer, 1989)
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From page 139... ...
Systems must inevitably make trade-offs among alternative ways of using available resources to benefit large groups (their members) .4 Guidelines, in the form of standards of minimum, necessary, or basic services to be covered by public or private health benefit plans, have been suggested as one vehicle for determining these social allocations (Hadorn, l991a,b,c)
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From page 140... ...
The case-finding rate in this program is considerably higher than the rate reported in non-risk-based programs. Screening guidelines are to some degree atypical examples of existing practice guidelines.
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From page 141... ...
. In making cost projections, the estimates should go beyond the immediate costs of managing a clinical problem or completing a procedure to encompass the costs related to follow-up care, supportive services, and other steps necessary for the service to make a difference to life expectancy, functional status, or some other result that matters to the patient.
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From page 142... ...
Again, ideally, those estimating costs for specific health care services or procedures would examine costs and health outcomes with the five questions below in mind.
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From page 143... ...
Judgments of this kind are made to some degree now, but the role that costs play in such judgments may not always be clearly described in guidelines or related materials. After much debate, and with some vigorous dissent, the committee concluded that initial developers of clinical practice guidelines need not use economic or cost criteria as explicit bases for recommendations on what constitutes appropriate care for particular clinical problems.
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From page 144... ...
In any case, whether developers of practice guidelines only provide cost estimates or choose also to make recommendations based on cost-effectiveness considerations, they must involve individuals with relevant expertise in cost-effectiveness analysis and cost projection in the development process. Further, they should disclose the role that cost information played in their judgments so potential users can assess the extent to which that information drove specific recommendations.
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From page 145... ...
· If evidence is sufficient to support several treatment options that have similar costs but different mixes of risks and benefits, respect for patient preferences generally would warrant informed patient choice. If costs of these treatment options differ, guidelines can illuminate but not answer the question of whether patients or third parties should be responsible for the costs of the more expensive option.
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From page 146... ...
. The following discussion looks first at questions typically raised under the rubric of "informed consent" and then turns to some issues often considered under the heading of "patient preferences." Informed Consent Patient communication and information can serve at least three objectives.
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From page 147... ...
Nonetheless, a narrow, legalistic interpretation of the concept should not obscure the potential for informed consent to act as a vehicle for fulfilling patient preferences and improving the quality of care. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983)
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From page 148... ...
That research has raised important questions about how to identify patient preferences, how to incorporate information about patient preferences into practice guidelines, and how to help patients make informed determinations about their preferences. Reflecting a traditional emphasis on practitioners' obligations, discussions about health care decisionmaking and patient preferences may not consider the ethical obligations and personal capacities of patients.
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From page 149... ...
Yet even if guideline developers and users become adept at identifying and recognizing patient preferences, problems will remain for decisionmakers. Respect for patient autonomy does not dictate that physicians must always act to help patients or their families implement their preferences (Brett and McCullough, 1986; Povar, 1991~.
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From page 150... ...
Even if policymakers somehow resolve questions about what care should be covered by private and public health benefit plans, other questions related to the provision of appropriate information remain. · Do all physicians have an equal responsibility to provide information about services that may have some benefit compared with alternative care, even when the more beneficial services are not available under the financing system or in the delivery setting in which they practice?
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From page 151... ...
A relatively obvious example is immunizations, which traditionally have not been covered by indemnity health plans but which clinicians routinely recommend, provide, or arrange for from public programs or other subsidized services. A more difficult case involves expensive services such as kidney transplants or dialysis, which some financing programs implicitly or explicitly ration on budgetary grounds.8 8 In Britain, the limiting of these services for patients over 55 years of age may have been facilitated by (and may also have contributed to)
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From page 152... ...
General Guidelines for Patient Information The committee also believes that a set of general guidelines for patient information and consent may need to be devised to supplement conditionor treatment-specific guidelines, on the one hand, and legally oriented patient consent forms, on the other. Such guidelines would discourage an unsophisticated, narrowly legalistic approach to informed consent and confront the limitations of common mechanisms of disseminating information to patients (Green, 1991; Hillman, 1991; Povar, 1991; Siu and Mittman, 1991~.
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From page 153... ...
To varying degrees, guidelines can help physicians and others by identifying how compelling is the case for particular services or courses of care under particular clinical circumstances. To further alleviate some of the strains on clinicians, some members of the committee argued strongly that developers of guidelines should specify the minimum (or basic or necessary)
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From page 154... ...
That argument is taking on new intensity and significance as proposals for health care reform call for a package of basic benefits to be defined and used more or less uniformly by public and private health insurance plans. More Definitions Adjectives such as "necessary" and "basic" are quite common in everyday language, but they also have certain specialized uses that may be inconsistent with each other and with what might be termed ordinary usage.
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From page 155... ...
Medicare regulations go a little further, referring to care that is safe and generally accepted by practitioners. Those health plans that use Value Health Sciences systems may be adopting, implicitly if not explicitly, the RAND definition of appropriate care-that is, that the medical benefits of a service exceed medical harms by a sufficient amount to make the service worth providing.
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From page 156... ...
· By their listing of basic benefits, some health care reform proposals seem to mean simply the ordinary kinds of health care services, settings, and providers covered in the typical (middle-class) health plan.
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From page 157... ...
Minimum care in this discussion is not a matter of requiring high deductibles and cost-sharing in health insurance plans but involves what specific services are covered by such plans. Practical and Policy Issues Even if a term such as minimum care is agreed upon, many difficult operational and policy questions confront efforts to specify just what constitutes such care.
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From page 158... ...
Efforts to define minimum care and set priorities for insurance coverage across the entire array of existing health services may run into additional challenges not faced by more incremental strategies. Collecting and analyzing information and making objective and subjective comparisons involving thousands of services and combinations of clinical circumstances constitute such a monumental undertaking that simplifying strategies inevitably arise.
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From page 159... ...
They also fear that such distinctions will preclude "excellent" care or will compromise a physician's sense of responsibility for a particular patient whose circumstances might justify more or different care. Whether other-than-minimum care should be defined as excellent care, however, raises questions about whether excellent care is to be distinguished by better expected health outcomes, better accommodation of patient preferences, or something else.
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From page 160... ...
However, guideline developers should attempt to describe the incremental benefit associated with particular courses of care. Some developers of guidelines may be technically, ethically, and politically positioned to propose minimum care for a limited set of clinical problems, but many others do not now and may never wish to assume this responsibility.
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From page 161... ...
The committee judged that it is not now strategically or tactically prudent to impose on all developers of clinical practice guidelines the task of explicitly recommending what care is warranted on economic as well as clinical grounds. Nor should guideline developers be uniformly expected to declare what services constitute the minimum or required care for a clinical problem.
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From page 162... ...
62 GUIDELINES FOR CLINICAL PRACTICE deploy resources and how the projections of health and cost outcomes offered by guidelines relate to their specific circumstances and objectives. A second, practical reason for the committee's position is that developers of guidelines may be nearly overwhelmed in responding to the expectations already laid out for them in this report and elsewhere.
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