Guidelines for Clinical Practice From Development to Use (1992) / Chapter Skim
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1 INTRODUCTION
1 INTRODUCTION
Pages 23-44
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From page 23... ...
Consumer and patient advocates focus on guidelines to inform patients' decisions, clarify patient preferences, and strengthen patient autonomy. Each group that has positive objectives for practice guidelines also fears their misuse.
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From page 24... ...
Practice guidelines are among the building blocks for informed patient decisionmaking and rational social judgments about what care should be covered by public and private health benefit plans. To the extent that guidelines provide well-argued translations of scientific research and expert judgment framed as statements about appropriate care, they will be more readily accepted by many kinds of decisionmakers.
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From page 25... ...
To conduct this more comprehensive examination of practice guidelines, the IOM appointed a committee of experts in the spring of 1990. Appointments included experts in medical and nursing practice, clinical and health services research, research methodology and program evaluation, medical informatics, and health care policy, financing, and administration.
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From page 26... ...
The term performance measures has no clear professional usage, and the 1990 report defined them provisionally as "methods or instruments to estimate or monitor the extent to which the actions of a health care practitioner or provider conform to medical review criteria and standards of quality."
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From page 27... ...
and a medical review criterion intended to assess care; they are different uses of the same clinical statement." The committee felt, on the whole, that distinguishing guidelines aimed at clinicians or patients from review criteria aimed at assessing care was useful even though the latter may and should draw on the former. In fact, given the importance accorded to quality assessment and cost containment objectives, some organizations may choose the development of review criteria as their starting point; however, the result may be statements that are presented in formats that are easy for review organizations to use but that are not readily employable by practitioners or patients.
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From page 28... ...
Thus, the first IOM committee on guidelines identified and discussed eight desirable attributes of guidelines for clinical practice. Chapter 5 of this report presents desirable attributes for medical review criteria.
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From page 29... ...
a statement of the strength of the evidence and the expert judgment behind the guidelines and (2) projections of the relevant health and cost outcomes of alternative courses of care.
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From page 30... ...
Practice guidelines should be accompanied by descriptions of the strength of the evidence and the expert judgment behind them. Practice guidelines should be accompanied by estimates of the health and cost outcomes expected from the interventions in question, compared with alternative practices.
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From page 31... ...
For example, the cost-effectiveness of screening for hypertension ($16,280 per quality-adjusted life year-or QALY for asymptomatic men aged 60) has been compared not only with other heart disease screening but also with treatment of heart disease (such as surgery for left main coronary artery disease, $4,500/QALY)
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From page 32... ...
When expert judgment proceeds in the absence of direct empirical evidence about a particular clinical practice, the general scientific reasoning or normative (ethical, professional) principles supporting the expert judgments should be described.
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From page 33... ...
Formal hypothesistesting processes range in strength from experimental to quasi-experimental to nonexperimental. However, a strong research design that is improperly executed may provide poorer evidence than a weaker but properly executed design.
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From page 34... ...
clinical research that evaluates patient outcomes for transfusions at this or other levels (Welch et al., 1991~. Clearly, however, for a physician faced with a woman bleeding to death from a ruptured ectopic pregnancy or some similar emergency, the absence of research on specific thresholds for transfusion cannot be a counsel for inaction.9 8As rated using a scheme formulated by the USPSTF, the statement was based on evidence rated "I" (drawn from at least one properly designed randomized clinical trial)
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From page 35... ...
Months of effort may be rendered largely or partly irrelevant by new information; for example, follow-up results may challenge earlier findings, or convincing findings from clinical trials may arise unexpectedly. This fact of life underscores the importance of processes for updating guidelines and for disseminating important contradictory research findings.
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From page 36... ...
with a single phrase: out-of-control health care costs. If, despite nearly two decades of intensifying efforts to contain spending, health care costs had not been increasing substantially faster than costs in other sectors, most of the recent legislation, conferences, and other activities to promote guidelines probably would not have happened despite the 10 For further discussion of reasons for focusing research or guidelines on clinical conditions or specific technologies, see IOM (1989b, 1990j; 1992)
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From page 37... ...
~A ~ = ~ More specifically, the growing interest in guidelines has been prompted by perceptions, first, that higher health care expenditures have brought only marginal health benefits and, second, that guidelines can help remedy this problem of "value." Virtually every major discussion of guidelines begins with a similar list of reasons for these perceptions (PPRC, 1988, 1989; IOM, 1989a; Billings, 1990; Leape, 1990; lIammons, 1991~. The discussion generally proceeds as follows.
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From page 38... ...
More research on outcomes and effectiveness of health care services is needed; more work should be done, using such research, to formulate specific guidelines for clinical practice; and more use of the resulting guidelines will help limit health care spending. How are guidelines to limit health care costs?
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From page 39... ...
The net impact of guidelines on the rate of increase in total health care spending cannot be predicted with confidence, even if future priorities for guidelines development stress clinical conditions for which costly overuse of services is suspected. Furthermore, the current system of delivering and financing care does not have incentives for economy and efficiency that are strong and consistent enough to capitalize fully on the opportunities for cost control that some guidelines present.
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From page 40... ...
reducing the risk of legal liability for negligent care. The first and second uses may reflect a fairly straightforward application of guidelines; the third and fourth typically entail the translation of guidelines into medical review criteria and other evaluation tools.
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From page 41... ...
For example, practitioners and institutions at financial risk from their participation in capitated, per-case, or other non-cost-based payment schemes may employ guidelines and review criteria to identify wasteful patterns of care, avoid expensive purchases of equipment with few approved indications for use, and forestall inappropriate referrals to specialist consultants. Public and private payers may use practice guidelines or review criteria to help them make broad decisions about whether to cover particular services (for example, pancreas transplants)
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From page 42... ...
Fifth, although effectiveness research and clinical practice guidelines can inform action and contribute to basic ethical debates over what constitutes an appropriate distribution of resources or an appropriate structure for health care delivery, they cannnot resolve those debates. Decisions depend on many other factors including political judgments, cultural norms, eco nomic calculations, and the power of affected interests.
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From page 43... ...
This chapter also considers actions of local organizations in adapting national guidelines, problems of conflicting or inconsistent guidelines, and efforts to translate guidelines into medical review criteria. In Chapter 8, the committee presents its views on the strengths and weaknesses of current efforts to develop and use clinical practice guidelines.
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From page 44... ...
SUMMARY The recent surge of interest in clinical practice guidelines was born of frustration about seemingly uncontrollable increases in health care expenditures combined with grave doubts about the real value of that increased spending. Very high expectations for what guidelines might do to control costs and improve the value or quality of care are, however, giving way to a more pragmatic appreciation of the potential and limitations of guidelines.
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