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Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods.

ABSTRACT: To compare three statistical strategies for classifying positive treatment response based on a dimensional measure (Yale Global Tic Severity Scale [YGTSS]) and a categorical measure (Clinical Global Impression-Improvement [CGI-I] scale).Subjects (N=232; 69.4% male; ages 9-69years) with Tourette syndrome or chronic tic disorder participated in one of two 10-week, randomized controlled trials comparing behavioral treatment to supportive therapy. The YGTSS and CGI-I were rated by clinicians blind to treatment assignment. We examined the percent reduction in the YGTSS-Total Tic Score (TTS) against Much Improved or Very Much Improved on the CGI-I, computed a signal detection analysis (SDA) and built a mixture model to classify dimensional response based on the change in the YGTSS-TTS.A 25% decrease on the YGTSS-TTS predicted positive response on the CGI-I during the trial. The SDA showed that a 25% reduction in the YGTSS-TTS provided optimal sensitivity (87%) and specificity (84%) for predicting positive response. Using a mixture model without consideration of the CGI-I, the dimensional response was defined by 23% (or greater) reduction on the YGTSS-TTS. The odds ratio (OR) of positive response (OR=5.68, 95% CI=[2.99, 10.78]) on the CGI-I for behavioral intervention was greater than the dimensional response (OR=2.86, 95% CI=[1.65, 4.99]).A 25% reduction on the YGTSS-TTS is highly predictive of positive response by all three analytic methods. For trained raters, however, tic severity alone does not drive the classification of positive response. Clinicaltrials.gov identifiers: NCT00218777; NCT00231985.

SUBMITTER: Jeon S

PROVIDER: S-EPMC3999642 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods.

Jeon Sangchoon S Walkup John T JT Woods Douglas W DW Peterson Alan A Piacentini John J Wilhelm Sabine S Katsovich Lily L McGuire Joseph F JF Dziura James J Scahill Lawrence L

Contemporary clinical trials 20130831 2

<h4>Objective</h4>To compare three statistical strategies for classifying positive treatment response based on a dimensional measure (Yale Global Tic Severity Scale [YGTSS]) and a categorical measure (Clinical Global Impression-Improvement [CGI-I] scale).<h4>Method</h4>Subjects (N=232; 69.4% male; ages 9-69years) with Tourette syndrome or chronic tic disorder participated in one of two 10-week, randomized controlled trials comparing behavioral treatment to supportive therapy. The YGTSS and CGI-I ...[more]

PMID: 24001701

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Project description:BackgroundUser engagement is key to the effectiveness of digital mental health interventions. Considerable research has examined the clinical outcomes of overall engagement with mental health apps (eg, frequency and duration of app use). However, few studies have examined how specific app use behaviors can drive change in outcomes. Understanding the clinical outcomes of more nuanced app use could inform the design of mental health apps that are more clinically effective to users.ObjectiveThis study aimed to classify user behaviors in a suite of mental health apps and examine how different types of app use are related to depression and anxiety outcomes. We also compare the clinical outcomes of specific types of app use with those of generic app use (ie, intensity and duration of app use) to understand what aspects of app use may drive symptom improvement.MethodsWe conducted a secondary analysis of system use data from an 8-week randomized trial of a suite of 13 mental health apps. We categorized app use behaviors through a mixed methods analysis combining qualitative content analysis and principal component analysis. Regression analyses were used to assess the association between app use and levels of depression and anxiety at the end of treatment.ResultsA total of 3 distinct clusters of app use behaviors were identified: learning, goal setting, and self-tracking. Each specific behavior had varied effects on outcomes. Participants who engaged in self-tracking experienced reduced depression symptoms, and those who engaged with learning and goal setting at a moderate level (ie, not too much or not too little) also had an improvement in depression. Notably, the combination of these 3 types of behaviors, what we termed "clinically meaningful use," accounted for roughly the same amount of variance as explained by the overall intensity of app use (ie, total number of app use sessions). This suggests that our categorization of app use behaviors succeeded in capturing app use associated with better outcomes. However, anxiety outcomes were neither associated with specific behaviors nor generic app use.ConclusionsThis study presents the first granular examination of user interactions with mental health apps and their effects on mental health outcomes. It has important implications for the design of mobile health interventions that aim to achieve greater user engagement and improved clinical efficacy.

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Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods.

Publications

Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods.

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