BACKGROUND: A reliable and meaningful quantitative index of success is paramount in the trial of any new treatment. However, existing methods for defining response and remission for treatments tested for psychiatric disorders are limited in that they often minimize the variance in change over time among individual patients and generally use arbitrarily chosen levels of functioning at specified times during treatment. PURPOSE: To suggest and determine the properties of an alternative measure of treatment success, the Illness Density Index (IDI), that may be more sensitive to fluctuations in symptoms over the course of treatment compared to existing measures. METHODS: We examined data from 64 depressed patients with multiple assessments of theHamilton Depression Rating Scale (HDRS) over 12 weeks of randomized treatment in order to compare and contrast varying numerical definitions of response and remission, including percent change and linear slope over time. RESULTS: Examination of the indices comparing the within-sample rank of individual patients revealed that these indices agree in cases where patients have little or no response as well as clear and sustained response, while they differ in patients who have a slow (or late) response as well as relapse during the treatment course. LIMITATIONS: The measure may not be useful for all types of studies, especially short-term treatment trials. CONCLUSIONS: The IDI is highly correlated with both categorical (e.g., remission) and continuous (e.g., percent change) definitions of treatment success. Furthermore, it differentiates certain trajectories of change that current definitions do not. Thus, the proposed index may be a valuable addition to current measures of efficacy, especially when trying to identify biological substrates of illness or predictors of long-term outcome.
RCT Entities:
BACKGROUND: A reliable and meaningful quantitative index of success is paramount in the trial of any new treatment. However, existing methods for defining response and remission for treatments tested for psychiatric disorders are limited in that they often minimize the variance in change over time among individual patients and generally use arbitrarily chosen levels of functioning at specified times during treatment. PURPOSE: To suggest and determine the properties of an alternative measure of treatment success, the Illness Density Index (IDI), that may be more sensitive to fluctuations in symptoms over the course of treatment compared to existing measures. METHODS: We examined data from 64 depressedpatients with multiple assessments of the Hamilton Depression Rating Scale (HDRS) over 12 weeks of randomized treatment in order to compare and contrast varying numerical definitions of response and remission, including percent change and linear slope over time. RESULTS: Examination of the indices comparing the within-sample rank of individual patients revealed that these indices agree in cases where patients have little or no response as well as clear and sustained response, while they differ in patients who have a slow (or late) response as well as relapse during the treatment course. LIMITATIONS: The measure may not be useful for all types of studies, especially short-term treatment trials. CONCLUSIONS: The IDI is highly correlated with both categorical (e.g., remission) and continuous (e.g., percent change) definitions of treatment success. Furthermore, it differentiates certain trajectories of change that current definitions do not. Thus, the proposed index may be a valuable addition to current measures of efficacy, especially when trying to identify biological substrates of illness or predictors of long-term outcome.
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