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The benefit of a new therapy is best judged by data from carefully conducted studies measuring the most relevant outcomes. Until recently, mortality, level of symptomatology, and laboratory and radiologic findings comprised the entire reported outcomes. The impact of treatments on patients’ perceptions of their physical, mental, and social health; driving ability; and employment—outcomes that are the focus of a study by Gilliam et al. in this issue of Neurology1—were rare. However, over the last decade, there has been a growing interest in developing reliable and valid tools to measure patient-oriented outcomes and applying them in treatment studies.2,3
Patient-oriented outcomes should be viewed as a subset of outcomes useful to the practicing clinician, rather than as distinct from or in conflict with traditional clinical outcomes. Until the early 1990s, treatment studies for epilepsy usually used a 50% reduction in seizure frequency either as the sole outcome or as the primary outcome, accompanied by frequencies of medication side effects. More recently, tools for measuring health-related quality of life have been developed and applied in a growing number of clinical studies of epilepsy, as well as other chronic conditions.4,5
In the Gilliam et al. study of temporal lobectomy for medically refractory epilepsy, patient-oriented outcome measures included a concerns index and a comprehensive measure of health-related quality of life.6,7 These outcome measures were completed by the study participants and reflect their own perspectives. The research methods for developing the concerns index included interviews and meetings with patients, which helped ensure that the measure included areas of concern important …
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