Modern Methods of Clinical Investigation (1990) / Chapter Skim
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4. What is Outcomes Research?
4. What is Outcomes Research?
Pages 33-46
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From page 33... ...
I want to take my cue from him and will discuss what our research team is doing that we call outcomes research. I then will return to Kuhn to make some more general observations about the status of outcomes research and the emergence of evaluative clinical sciences as a response to medicine's current predicament.
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From page 34... ...
Our BPH assessment team consists of research urologists, medical care epidemiologists, decision analysts, statisticians, psychometricians, computer scientists, and experts In interactive videodisc technology (see Table 4.11. At issue is the treatment of prostatism or obstruction of the urinary tract due to benign hyperplasia of the prostate gland.
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From page 35... ...
The assessment team tested this conflict in theory and reached several conclusions. Evidence from the literature and from claims data demonstrated that the preventive theory was incorrect: an operation in patients with uncomplicated BPH which most patients have very likely causes a slight decrease in life expectancy.
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From page 36... ...
The effect of practice style on variation in prostatectomy rates was traced to an incorrect belief in the preventive theory of early prostatectomy and TABLE 4.2 Synopsis of BPH assessment: Prostatectomy versus watchful waiting Steps Used in the BPH Assessment Evaluative Clinical Sciences: Methods/Disciplines Identify treatment theories and evaluate Identify and develop measures of relevant outcomes from patient's and from physician's points of view Undertake non-experimental studies to estimate (missing) outcomes probabilities Integrate information from all sources to test preventive theory and evaluate importance of patient utilities Structured review of the literature; meta-analysis; focus groups with .
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From page 37... ...
ENGAGING PATIENTS IN THE DECISION PROCESS We are seeking new ways to engage patients in the decision process and to make our detailed probability estimates available to patients and physicians in "real time" for use in clinical decision making. To do this, we have developed a "BPH Shared Medical Decision Making Procedure" based on interactive videodisc technology.
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From page 38... ...
We also found new techniques for treating BPH based on balloon dilation and identified two promising drugs undergoing FDA evaluation, a less invasive operative technique (prostatotomy) , and a microwave diathermy treatment which is thought to relieve symptoms by reducing prostate size through the scarring of tissue.
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From page 39... ...
When the outcomes of alternative treatments for a given condition are asymmetric in some significant dimension say, known differences in the risk of death patient preferences with regard to what is known about these risks should influence treatment assignments. This is a strong challenge for the planning of further studies of watchful waiting versus TURP, where the uncertainty is not even about the "main treatment effect" probabilities, but about prognosis in certain subgroups on the watchful waiting arm.
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From page 40... ...
is needed to present information uniformly to patients in all cooperating centers. On one arm of the trial, patients are offered surgery, watchful waiting, or the opportunity to participate in a double-blind, placebo-controlled randomized clinical trial of prazosin, based on the full disclosure of information which the ethics of shared patient decision making requires.
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From page 41... ...
The correct probabilities are those based on preference trials, where patients knowingly choose treatments on the basis of information about probabilities for the outcomes relevant to them. However, reliance on preference trials makes sense only if we can distinguish therapeutic effects from the effects of preference, placebo, and compliance.
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From page 42... ...
The clinical trial thus provides the opportunity for direct comparison of new technologies balloon dilation, microwave diathermy, and the new drugs with surgery and watchful waiting. We hope that the clinical trial will provide the essential information on the outcome of all new treatment theories relevant to treatment of BPH.
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From page 43... ...
The controversy here is about the role of patient risk factors as the confounding variables responsible for higher mortality rates following TURP. Well-conducted and largescale randomized clinical trials give assurance that patient differences do not confound treatment effects.
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From page 44... ...
The anomalies of rational agency theory are now evident to a widening audience. It is increasingly apparent that the large investment in biomedical science has not resulted in a consensus among physicians on the correct way to practice medicine, nor has it resulted in orderly assessment of treatment theories.
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From page 45... ...
More and more, government and private corporations are intruding into the doctor-patient relationship in their attempts to control demand. The emergence of the evaluative clinical sciences and outcomes research is a response to the intellectual crisis created by the demise of the rational agency theory and the loss of faith that biomedical science, through its own internal logic, assures effective medical practice.
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From page 46... ...
Watchful waiting versus immediate transurethral resection for symptomatic prostatism. Journal of the American Medical Association 1988;259:301~3017.
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