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Approaches to denote treatment outcome: Clinical significance and clinical global impression compared.

ABSTRACT: OBJECTIVES:The authors of a previous study proposed a statistically based approach to denote treatment outcome, translating pretest and posttest scores into clinically relevant categories, such as recovery and reliable improvement. We assessed the convergent validity of the Jacobson-Truax (JT) approach, using T-score based cutoff values, with ratings by an independent evaluator. METHODS:Pretest and retest scores on the Brief Symptom Inventory (BSI) and clinical global impression improvement (CGI-I) ratings were collected repeatedly through routine outcome monitoring from 5,900 outpatients with common mental disorders. Data were collected in everyday practice in a large mental health care provider. RESULTS:Continuous pretest-to-retest BSI change scores had a stronger association with CGI-I than the categorical variable based on JT. However, JT categorization and improvement according to CGI converged substantially with association indices (Somers' D) ranging from D = .50 to .56. Discordance was predominantly due to a more positive outcome according to JT than on CGI-I ratings. CONCLUSION:Converting continuous outcome variables into clinically meaningful categories comes at the price of somewhat diminished concurrent validity with CGI-I. Nevertheless, support was found for the proposed threshold values for reliable change and recovery, and the outcome denoted in these terms corresponded with CGI improvement for most patients.

SUBMITTER: de Beurs E

PROVIDER: S-EPMC7649961 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Approaches to denote treatment outcome: Clinical significance and clinical global impression compared.

de Beurs Edwin E Carlier Ingrid V E IVE van Hemert Albert M AM

International journal of methods in psychiatric research 20191009 4

<h4>Objectives</h4>The authors of a previous study proposed a statistically based approach to denote treatment outcome, translating pretest and posttest scores into clinically relevant categories, such as recovery and reliable improvement. We assessed the convergent validity of the Jacobson-Truax (JT) approach, using T-score based cutoff values, with ratings by an independent evaluator.<h4>Methods</h4>Pretest and retest scores on the Brief Symptom Inventory (BSI) and clinical global impression i ...[more]

PMID: 31597212

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Project description:Introduction: The Clinical Global Impressions-Improvement (CGI-I) scale is widely used in clinical research to assess symptoms and functioning in the context of treatment. The correlates of the CGI-I with efficacy scales for adolescent major depressive disorder are poorly understood. This study focused on benchmarking CGI-I scores with changes in the Children's Depression Rating Scale-Revised (CDRS-R) and the Quick Inventory of Depressive Symptomatology-Adolescent (17-item) Self-Report (QIDS-A17-SR). Methods: We examined three datasets with the clinician-rated CDRS-R to ascertain equivalent percent changes in total scores and CGI-I ratings. Exploratory analyses examined corresponding percentage changes in the QIDS-A17-SR and the CGI-I ratings. The CGI-I was the reference scale for nonparametric equipercentile linking with the Equate package in R. Results: CGI-I scores of 1 mapped to ≥78%-95% change in CDRS-R scores at 4-6 weeks across three datasets. CGI-I scores of 2 mapped to 56%-94% change in CDRS-R scores at 4-6 weeks across three studies. CGI-I scores of 3 mapped to 30%-68% changes in CDRS-R scores at 4-6 weeks across three studies. CGI-I scores of 4 mapped to a range of 29%-44% at 4-6 weeks across three studies. There was no significant difference (p ≥ 0.6) between treatment groups in both the Treatment of Adolescents with Depression and Treatment of Resistant Depression in Adolescents studies, for each CGI-I score ( = 1, or = 2 or = 3, or ≥4), associated mapping of total depression severity score, or associated percent change from baseline for corresponding follow-up visits. There was no significant sex difference (p > 0.2) in CGI-I linkages to CDRS-R total or percentage changes. Conclusions: These findings establish clear relationships among CGI-I scores and the CDRS-R and the QIDS-A17-SR. These benchmarks have utility for clinical trial study design, inter-rater reliability training, and clinical implementation.

Project description:BackgroundThe Clinical Global Impression-Severity (CGI-S) and CGI-Improvement (CGI-I) scales are widely accepted tools that measure overall disease severity and change, synthesizing the clinician's impression of the global state of an individual. Frequently employed in clinical trials for neuropsychiatric disorders, the CGI scales are typically used in conjunction with disease-specific rating scales. When no disease-specific rating scale is available, the CGI scales can be adapted to reflect the specific symptom domains that are relevant to the disorder. Angelman syndrome (AS) is a rare, clinically heterogeneous condition for which there is no disease-specific rating scale. This paper describes efforts to develop standardized, adapted CGI scales specific to AS for use in clinical trials.MethodsIn order to develop adapted CGI scales specific to AS, we (1) reviewed literature and interviewed caregivers and clinicians to determine the most impactful symptoms, (2) engaged expert panels to define and operationalize the symptom domains identified, (3) developed detailed rating anchors for each domain and for global severity and improvement ratings, (4) reviewed the anchors with expert clinicians and established minimally clinically meaningful change for each symptom domain, and (5) generated mock patient vignettes to test the reliability of the resulting scales and to standardize rater training. This systematic approach to developing, validating, and training raters on a standardized, adapted CGI scale specifically for AS is described herein.ResultsThe resulting CGI-S/I-AS scales capture six critical domains (behavior, gross and fine motor function, expressive and receptive communication, and sleep) defined by caregivers and expert clinicians as the most challenging for patients with AS and their families.ConclusionsRigorous training and careful calibration for clinicians will allow the CGI-S/-I-AS scales to be reliable in the context of randomized controlled trials. The CGI-S/-I-AS scales are being utilized in a Phase 3 trial of gaboxadol for the treatment of AS.

Project description:BackgroundIn clinical trials for rare diseases, such as Duchenne muscular dystrophy, clinical outcome assessments (COA) used to assess treatment benefit are often generic and may not be sensitive enough to detect change in specific patient populations. Thus, there is a need for disease specific COAs that track meaningful change among individuals. When developing such measures, input from clinicians, caregivers and patients is critical for assessing clinically relevant concepts and ensuring validity of the measure.MethodThe aim of this study was to develop two Duchenne-specific global impression items for use in clinical trials. The development of the Duchenne Clinical Global Impression of Change (CGI-C) and Caregiver Global Impression of Change (CaGI-C) was informed by findings from concept elicitation (CE) interviews with clinicians, caregivers and individuals with Duchenne. Through cognitive debriefing (CD) interviews, clinicians and caregivers evaluated draft CGI-C and CaGI-C items to ensure relevance and understanding of the items and instructions. Suggestions made during the CD interviews were incorporated into the finalized CGI-C and CaGI-C measures.ResultsThe symptoms most frequently reported by clinicians, caregivers and individuals with Duchenne were muscle weakness, fatigue, cardiac difficulties and pain. Regarding physical functioning, all three populations noted that small changes in functional ability were meaningful, particularly when independence was impacted. Caregivers and clinicians reported that changes in speed, endurance and quality of movement were important, as was improvement in the ability of individuals to keep up with their peers. A change in the ability to complete everyday activities was also significant to families. These results were used to create two global impression of change items and instruction documents for use by clinicians (CGI-C) and caregivers (CaGI-C). Overall, both items were well understood by participants. The descriptions and examples developed from the CE interviews were reported to be relevant and appropriate for illustrating different levels of meaningful change in patients with Duchenne. Modifications were made based on caregiver and clinician CD feedback .ConclusionsAs part of a holistic measurement strategy, such COA can be incorporated into the clinical trial setting to assess global changes in relevant symptoms and functional impacts associated with Duchenne.

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Approaches to denote treatment outcome: Clinical significance and clinical global impression compared.

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Approaches to denote treatment outcome: Clinical significance and clinical global impression compared.

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