Adopting New Medical Technology (1994) / Chapter Skim
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11. STRENGTHENING THE CONNECTION BETWEEN EVALUATIVE RESEARCH AND COVERAGE DECISIONMAKING
11. STRENGTHENING THE CONNECTION BETWEEN EVALUATIVE RESEARCH AND COVERAGE DECISIONMAKING
Pages 127-151
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From page 127... ...
The charge of the new agency was to "enhance the quality, appropriateness, and effectiveness of health care services." In addition to the expansion of outcomesrelated research projects, the agency's mandate included the creation of new initiatives in clinical practice guidelines development and dissemination (Congressional Record, 1989~. This significant expansion of federal support for medical effectiveness research resulted in part from evidence, accumulated over the previous two decades, of significant variations in the use of a wide variety of medical and surgical technologies (Chassin et al., 1986; Lewis, 1969; Wenoberg and Gittlesohn, 1973, 1982)
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From page 128... ...
For drugs, it is much more difficult, because drug approval requires several stages of clinical trials. Whether it is a drug, a device, or a procedure, the end result is similar: a new technology is usually disseminated, and paid for, without it having been established that the technology is either (1)
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From page 129... ...
surgery clearly improves long-term survival in patients with threevessel or left main coronary artery disease (Alderman et al., 1990) , but there is little evidence that survival is improved in patients with single-vessel disease.
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From page 130... ...
Effectiveness is a measure of whether the technology works in general clinical practice-outside of the research environment. For example, CABG surgery has been shown to reduce substantially the death rate in patients with left main coronary artery disease, but not in patients with disease in a single branch vessel.
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From page 131... ...
Retrospective data usually consist of information collected for another purpose, such as medical records, discharge abstracts, or health insurance claims, but retrospective data may also include interviews or surveys of patients or care givers. The most useful outcomes information comes from controlled studies in which treatment effects are determined by comparing outcomes in patients who receive the treatment with those in similar patients who do not.
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From page 132... ...
. The outcomes data to be collected (survival, symptom relief, health status, etc.)
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From page 133... ...
Statewide Discharge Databases Statewide discharge databases use data from patients' hospital records which have been abstracted by personnel from the medical records office. These discharge abstracts summarize key clinical and demographic data that can be used for outcomes analysis.
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From page 134... ...
As such, they permit population-based analyses of regional variations in the use of various services and calculation of overall mortality rates as well as provide some other outcomes data, such as readmission or reoperation rates. Like registry data, this information is uncontrolled.
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From page 135... ...
This has recently been corrected. The Uniform Clinical Data Set The Health Care Financing Administration has investigated the practicality of abstracting much more clinical information directly from medical records.
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From page 136... ...
23 ~ 2 3 10 11 15 17 22 23 25 33 44 55 57 60 65 149 4 316 1,793 2,544 2,651 3,311 3,929 5,452 5,767 5,928 19,821 20,813 45,947 46,293 46,916 I 1 1 1 1 ' 1 1 ~1 1 1 1 1 2 P = 0.0059 P < 0.001 Favors Treatment Favors Control FIGURE 11-1 Cumulative meta-analyses of 60 trials of intravenous thrombolytic agents. "1" indicates that no difference from untreated patients.
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From page 137... ...
Outcomes data from all sources-RCTs, meta-analyses, and studies of claims data, discharge data, registries, and clinical series are evaluated. The expert panels comprise individuals who have vast clinical experience and who often have participated in many of the studies that generated the outcomes data.
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From page 138... ...
For example, the RAND evaluation scheme for CABG surgery required appropriateness judgments for nearly 3,000 distinct and different clinical scenarios that incorporate the major risk and severity factors for coronary artery disease (Leape et al., 1991~. Decision Analysis Decision analysis is an analytic tool for assessing alternative treatments by the use of branched chain logic (Kassirer et al., 1987; Lusted, 1968; McNeil et al., 1975; Weinstein et al., 1980~.
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From page 139... ...
The validity of decision analysis depends on the validity of the values used for probability and utility. If outcomes data and measures of patient utilities are available, they are used.
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From page 140... ...
To determine the appropriateness of using a treatment for a specific clinical scenario, it is necessary to evaluate the outcomes data that do exist and "fill in the holes" when data are lacking. Appropriateness studies address these issues by obtaining group judgments from expert clinicians who evaluate all the available outcomes data and provide judgments from their own clinical experience for those situations where scientific evidence of effectiveness does not exist.
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From page 141... ...
The validities of the estimates, as well as the global judgments, therefore depend in part on how experts are selected. Practice Guidelines Practice guidelines are a means by which the results of outcomes and appropriateness studies are simplified and made accessible to clinicians (Leape, 1990~.
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From page 142... ...
For many hightechnology therapeutic or diagnostic options, the relevant level of analysis is much more detailed: What is the cost-effectiveness of CABG surgery for a 60year-old diabetic female with left main artery disease, a normal stress test, and good ventricular function? What is the cost effectiveness of CABG surgery for a
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From page 143... ...
Second, services should be compared and ranked according to these judgments. Third, we must decide what we will and will not pay for as part of a basic benefits package that is provided for all citizens.
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From page 144... ...
Although the recent expansion of the outcomes research effort with PORT projects and guideline development is encouraging, these are really only pilot projectsfeasibility studies. I think they will be successful, but the number of treatments being evaluated is a tiny fraction of what is needed for even the high-cost technologies.
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From page 145... ...
We make the trade-offs now, providing liver transplants for some and no prenatal care for others, but we make them by default and by ability to pay, not by deliberation and choice. At some point in the not too distant future, we will get serious about reducing health care costs.
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From page 146... ...
If there is to be a basic benefits package, it must apply to all. We Have Not Made Decisionmaking a Public Process We have it all backwards.
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From page 147... ...
RECOMMENDATIONS The Federal Government's Role To relate adoption decisions to evaluative research, we need much more evaluative research. We must vastly expand and strengthen all aspects of technology assessment: effectiveness and outcomes research, appropriateness research, the methodology of determining patient preferences, and methods for performing the trade-off decisions among competing technologies.
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From page 148... ...
Inappropriate services would be prohibited, but other services that were not included in the basic benefits package could be available under a self-pay or optional insurance program. Established Technologies For medical technologies now in use, the same judgments described above for new technologies would need to be made.
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From page 149... ...
1990. Ten-year follow-up of survival and myocardial infarction in the randomized Coronary Artery Surgery Study.
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From page 150... ...
1987. Results of a second-opinion program for coronary artery bypass graft surgery.
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From page 151... ...
1987. Association of volume with outcome of coronary artery bypass graft surgery.
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