Clinical Utility

What does “clinical utility” mean to the common individual? Collyar asked. Most often, it means reliability—is a test going to predict how someone will react to a treatment, and what are the ramifications from the decisions that are made on the basis of the information gained? Most tests focus on a single marker, but the human body is an integrated circuit with many pathways that interact. Tests of single markers therefore need to fit into a diagnostic whole that includes imaging, clinical examinations, exploratory surgery, and so on. In general, however, “clinical utility” does not mean much to most people. A more relevant concept is “personal utility” or “personal guidance.”

From this perspective, people want to get test results in a reasonable time frame and have results explained in clear language, Collyar said. Health care providers should be comfortable interpreting the test information and conveying what result is most important. In addition, test results need to be updated quickly as the test or a person’s condition changes, with medical personnel receiving adequate training to keep up to date with rapidly changing technologies. Patients also need to have the choice to receive test results because some people will want to know a result even if no intervention is available, but others will not. Also, if a test has implications for family members, people want counseling because of the immense consequences for families that can follow the results.

Patients and advocates want the health care and research worlds to honor the true meaning of “patient-centered,” according to Collyar. “Nothing about us without us” is a key message—“we need to be involved in the dialogue.” Also, when groups are asked, they are all interested in being included in research, Collyar added, and they need to be so they are not excluded from the benefits of research.

From the perspective of the public and of patients, failures in developing molecular diagnostics can waste time and money, erode trust, and cost lives. “We have to get this right,” Collyar said.



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