Overview of cost-consequence modeling in outcomes research

Outcomes research has developed in response to the need for information on costs, risks, and benefits of clinical treatments, including data regarding the effectiveness of prescription drugs. It attempts to consider more than the biologic effects of pharmaceuticals, that is, to encompass wider measures of the results of their use, issues that are not routinely addressed during clinical trials. Cost-effectiveness analysis compares the outcome of different treatment options in terms of monetary cost per unit of effectiveness. Examples of measures of effectiveness are years of life saved, number of days of hospitalization avoided, and number of treatment successes. Cost-consequence models, also referred to as cost-outcome models, deal with costs and a variety of outcomes ranging from clinical to humanistic. Direct medical costs are those for prevention, detection, treatment, and rehabilitation; they are amounts spent to treat an illness, including hospitalization, professional services, pharmaceuticals, and medical supplies. Indirect medical costs are associated with changes in productivity, such as earnings lost because of illness. Humanistic outcomes deal primarily with functional status, quality of life, and satisfaction, and may include pain, anxiety, self-esteem, ability to carry out normal activities, and overall impressions. Since it is not possible to study all effects of treatments with clinical trials, modeling techniques are useful in making therapeutic decisions.