Outcomes theories differ based on tools, models
Many question practical applications
There are four leading theories concerning outcomes measurement and reporting, and all are in their infancy. The following is an overview of their approaches and criteria.
The American College of Clinical Pharmacy (ACCP) is stressing a patient-based outcomes assessment centered around the SF-36 questionnaire. By scoring aspects of a patient’s physical functioning, pain, general health, vitality, social functioning, and emotional and mental health, the patient’s point of view can become an outcome variable, according to its authors.
"It’s definitely an interdisciplinary approach. The focus is not on the drug outcome, but the patient outcome," says Kathy Bungay, PharmD, senior project director of the New England Medical Center Hospital Health Institute in Boston. (See "Relationships Among Measures of Patient Outcomes in a Quality of Life Model", p. 206.)
In an ACCP report written by Anita Wagner, PharmD, assistant clinical professor in the department of neurology at Tufts University School of Medicine in Boston, ACCP recommends five categories of health outcomes: biological and physiological, symptoms, functioning, general health perceptions, and quality of life. It stresses that a practitioner’s notions of the outcomes of therapy can be different from quality of life considerations important to the patient. By using the questionnaire as a health status measure, it can assist in a mutually desirable approach to treatment outcomes.
In his paper titled, "Improving the Quality of Outcomes Research Involving Pharmaceutical Services," David Holdford, PhD, assistant professor of pharmacy administration at Virginia Commonwealth University’s Medical College of Virginia in Richmond, concludes that the pharmacy can add quality and value to outcomes, but to date, just how much has not been established because there has been too much anecdotal and too little empirical evidence.
He maintains that some approaches deemed outcomes should be called therapeutic endpoints, which he says have no "true meaning." As an example, he points to the flawed notion of clot dissolution time as an outcome for thrombolytic therapy. If the drug has no "significant" effect on the survival rate after myocardial infarction, it can’t be a viable outcome. Similarly, he argues that drug interactions are intermediate measures, not outcomes, and drug selection, concentrations, dosages, and compliance are processes, not outcomes.
Holdford says clinical outcomes should be tied only to "measures such as morbidity and mortality that can be considered the end results of antecedent medical care." Clinical markers, though, should not be called outcomes, he writes, because they are intermediate measures rather than the end results of care.
In an interview with Drug Utilization Review, Holdford offered some advice to pharmacists embarking on outcomes research. "Many times, what we do as pharmacists is too far removed or too difficult to quantify in terms of our effectiveness on health outcomes, so we have intermediate outcomes or pharmacy care. What matters there is who the outcomes reporting is going to. First you must ask yourself who are your customers, and then who’s going to have an influence on the ability to achieve the organization’s goals?"
The Center for Pharmaceutical Outcomes Research (CePOR) at the University of North Carolina at Chapel Hill emphasizes that clinical and economic aspects of outcomes research must go hand in hand. "Outcomes research started very much driven by economics, but in recent years other questions are being asked as well," says Sue Tolleson-Rinehart, associate director. "I think pharmacy outcomes are being broadly defined, and whether they must be departmental or systemwide, making them one or the other is too narrow."
The organization believes that outcomes quality has two paths: that of individual patient care and that of population-based care. Like other analysts, CePOR researchers note that pharmacy "structures or processes" do not adequately measure or determine patient outcomes. Another similarity is the notion that clinical trials and clinical practice cannot be counted on to offer comparable outcomes.
A focus on cost analysis
The Association for Pharmacoeconomics and Outcomes Research (APOR) has focused its analysis on two fronts, the cost-benefit analysis and the cost-effectiveness analysis, with both having benefits and limitations in terms of outcomes.
A cost-benefit analysis is defined as one comparing total benefits with total costs, with this ratio-based approach offering the advantages of comparing economic strategies among vastly different interventions. The major drawback APOR sees in this analysis is the almost impossible need to attribute a numerical value to the outcomes and benefits of any health intervention. A cost-effectiveness analysis, on the other hand, does not place a value on an outcome but assumes the outcome is worth pursuing and sets out to find the most efficient way to reach it. APOR also offers cautions on the use of database analysis and the controlled clinical trial.
Whether from insurance claims, HMOs, hospitals, or any number of sources, APOR states that while a database analysis is usually efficient and often useful, there are drawbacks. They include a retrospective nature, which may not include all of the intervention options at hand, for example. Also, database analysis may be unable to adequately predict what economic value would ensue if providers changed their prescribing and practicing habits.
Controlled clinical trials get similar treatment from APOR as from other industry sources surveyed on this topic. Simply put, controlled clinical trials lack "real world" aspects, possibly making the results meaningless. Medication compliance is cited as a major limiting factor in the worth of a controlled clinical trial that could not be postulated elsewhere for a viable outcome to measure.
[For more information, contact: The American College of Clinical Pharmacy, 3101 Broadway, Kansas City, MO 64111. Telephone: (816) 531-4990. David Holdford, PhD, Virginia Commonwealth University, 410 North 12th St., Richmond, VA 23298. Telephone: (804) 828-6103. The Center for Pharmaceutical Outcomes Research, Sue Tolleson-Rinehart, Associate Director, CB# 7360, University of North Carolina, Chapel Hill, NC 27599. Telephone: (919) 962-0081. The Association for Pharmacoeconomics and Outcomes Research, Marilyn Dix Smith, Executive Director, 20 Nassau St., Princeton, NJ 08542. Telephone: (609) 452-0209.]
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