scholarly journals Development of an adapted Clinical Global Impression scale for use in Angelman syndrome

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Alexander Kolevzon ◽  
Pamela Ventola ◽  
Christopher J. Keary ◽  
Gali Heimer ◽  
Jeffrey L. Neul ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Global Impression ◽  
Angelman Syndrome ◽  
Rating Scales ◽  
Rating Scale ◽  
Fine Motor ◽  
Rater Training ◽  
Specific Symptom ◽  
Symptom Domains ◽  
Disease Specific

Abstract Background The 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. Methods In 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. Results The 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. Conclusions Rigorous 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.

scholarly journals Trends in (not) using scales in major depression: A categorization and clinical orientation

2020 ◽  
Vol 63 (1) ◽  
Author(s):  
Koen Demyttenaere ◽  
Liesbeth Jaspers
Keyword(s):  
Major Depression ◽  
Rating Scales ◽  
Rating Scale ◽  
Assessment Tools ◽  
Treatment Expectations ◽  
Current Trends ◽  
Clinical Orientation ◽  
Current Assessment ◽  
The Individual ◽  
Disease Specific

Abstract Background Standard depression rating scales like the Hamilton Depression Rating Scale and the Montgomery–Åsberg Depression Rating Scale were developed more than 40 years ago. They are mandatory in clinical trials but are for a variety of reasons seldom used in clinical practice. Moreover, most clinicians are less familiar with more recent trends or with some dilemmas in assessment tools for major depression. Methods Narrative review. Results Asssessment tools can be observer-rating or self-rating scales, disease-specific or non–disease-specific scales, subjective scales or objective lab assessments, standard questionnaires or experience sampling methods. An overarching question is to what degree current assessment methods really address the individual patient’s needs and treatment expectations. Conclusions The present paper aims to offer a framework for understanding the current trends in assessment tools that can orientate and guide the clinician.

scholarly journals THE EFFECTIVENESS OF VSTEP.3-5 SPEAKING RATER TRAINING

2020 ◽  
Vol 36 (4) ◽  
Author(s):  
Nguyen Thi Ngoc Quynh ◽  
Nguyen Thi Quynh Yen ◽  
Tran Thi Thu Hien ◽  
Nguyen Thi Phuong Thao ◽  
Bui Thien Sao ◽  
...  
Keyword(s):  
Training Program ◽  
Large Scale ◽  
Rating Scales ◽  
Rating Scale ◽  
Training Session ◽  
Vital Role ◽  
International Studies ◽  
Rater Training ◽  
The Impact ◽  
Band Separation

Playing a vital role in assuring reliability of language performance assessment, rater training has been a topic of interest in research on large-scale testing. Similarly, in the context of VSTEP, the effectiveness of the rater training program has been of great concern. Thus, this research was conducted to investigate the impact of the VSTEP speaking rating scale training session in the rater training program provided by University of Languages and International Studies - Vietnam National University, Hanoi. Data were collected from 37 rater trainees of the program. Their ratings before and after the training session on the VSTEP.3-5 speaking rating scales were then compared. Particularly, dimensions of score reliability, criterion difficulty, rater severity, rater fit, rater bias, and score band separation were analyzed. Positive results were detected when the post-training ratings were shown to be more reliable, consistent, and distinguishable. Improvements were more noticeable for the score band separation and slighter in other aspects. Meaningful implications in terms of both future practices of rater training and rater training research methodology could be drawn from the study.

scholarly journals Efficacy, tolerability, and preference of mirtazapine orally disintegrating tablets in depressed patients: a 17-week naturalistic study in Lithuania

Medicina ◽  
2009 ◽  
Vol 45 (10) ◽  
pp. 778 ◽  
Author(s):  
Vita Danilevičiūtė ◽  
Audrius Sveikata ◽  
Virginija Adomaitienė ◽  
Gintautas Gumbrevičius ◽  
Vidmantas Fokas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Clinical Global Impression ◽  
Rating Scale ◽  
Naturalistic Study ◽  
Controlled Clinical Trials ◽  
Orally Disintegrating Tablet ◽  
Depressed Patients ◽  
Orally Disintegrating Tablets ◽  
The Mean

Mirtazapine is an established antidepressant with well-documented efficacy demonstrated in controlled clinical trials. However, the gap between the results obtained in controlled clinical trials and everyday clinical practice exists. Therefore, the importance of naturalistic studies in psychiatry is becoming recognized. The aim of present naturalistic study was to acquire data on efficacy, safety, and preference of mirtazapine orally disintegrating tablets during a 17-week treatment of depression. This prospective, open-label, multicenter study in patients with mild to severe depression was conducted at 47 mental health centers of Lithuania by 78 psychiatrists. Patients were initially given 15 mg or 30 mg of mirtazapine orally disintegrating tablets; the maximum allowed dose was 45 mg per day. The primary efficacy measure was the total score on the Hamilton Depression Rating Scale-17 (HAMD-17), the Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Improvement (CGI-I) scales. Tolerability was primarily measured by assessing the incidence of treatment-emergent adverse events. Patients were evaluated at baseline, at weeks 1, 5, 9, 13, and 17. A total of 779 patients (595 women [76.4%] with a mean [SD] age of 50.2 [13.65] and 184 men [23.6%] with a mean [SD] age of 52.4 [14.6] years) were enrolled into the study; 687 (88.2%) patients completed the study. The mean (SD) daily dose of mirtazapine orally disintegrating tablets was 29.0 (3.8) mg. The mean total (SD) HAMD-17 score improved significantly from 25.7 (4.6) to 7.3 (4.3) (P<0.005). At each visit, the mean HAMD-17 score was significantly lower than that at the preceding visit. At week 17, remission (HAMD-17 score < or =7) was observed in 436 (56%) patients. The mean (SD) CGI-S score improved significantly from 4.9 (1.0) at baseline to 1.5 (0.6) at endpoint (P<0.001). According to the CGI-I assessments, 621 patients (89.4%) improved and improved very much. The vast majority of patients (80%) preferred the new formulation of mirtazapine – mirtazapine orally disintegrating tablet. Treatment-emergent adverse events occurred in 106 patients (13.6%). The most frequent adverse events were weight gain, sedation, dizziness, and dry mouth. In this study conducted in Lithuania with depressed patients, a significant improvement was shown in all efficacy measures. In addition, mirtazapine orally disintegrating tablet was a well-tolerated and preferable formulation for the treatment of depressed patients.

scholarly journals N-Methyl-D-Aspartate Antagonists in Levodopa Induced Dyskinesia: A Meta-Analysis

2012 ◽  
Vol 39 (4) ◽  
pp. 465-472 ◽  
Author(s):  
Behzad Elahi ◽  
Nicolás Phielipp ◽  
Robert Chen
Keyword(s):  
Clinical Trials ◽  
Nmda Receptor ◽  
Rating Scales ◽  
Rating Scale ◽  
Meta Analysis ◽  
Nmda Receptor Antagonists ◽  
Controlled Clinical Trials ◽  
Receptor Antagonists ◽  
Peak Dose ◽  
Standard Mean Difference

Background:Levodopa-induced dyskinesias (LID) are amongst the most disabling side-effects of levodopa therapy for Parkinson's disease (PD). It has been suggested that that N-Methyl-D-Aspartate (NMDA)-receptor antagonist may reduce peak-dose dyskinesia in PD patients and may lead to motor improvement. In this study, we compared the efficacy of NMDA receptor antagonists versus placebo in the treatment of LID in PD through a meta-analysis of controlled trials.Methods:Electronic search of Pubmed (1990 - 2010), Medline (1966-2010), EMBASE (1974-2010) and other databases for relevant studies were performed. Controlled clinical trials of the effects of NMDA antagonists on LID that fulfill the study protocol were selected. Pooled data from included studies was then used to perform random and fixed effect models meta-analysis.Results:The search resulted in 11 randomized, placebo controlled clinical trials that involved a total of 253 PD patients with peak-dose LID. The outcome measures were various dyskinesia rating scales and the Unified Parkinson Disease Rating Scale (UPDRS) subscales III and IV. The analysis showed significant reduction in Standard Mean Difference (SMD) for UPDRS IV (SMD -1.45; 95% CI -2.28 to -0.63) and UPDRS III (SMD -0.41; 95% CI -0.69 to -0.12) after treatment with amantadine. Other included drugs did not show significant change in the outcomes measured.Conclusion:This meta-analysis provides an update on the clinical trials and confirms the short-term benefits of amantadine therapy in the treatment of dyskinesia. The effects of other NMDA receptor antagonists need to be evaluated further in clinical trials.

scholarly journals Dichotomizing rating scale scores in psychiatry: a bad idea?

2012 ◽  
Vol 22 (1) ◽  
pp. 17-19 ◽  
Author(s):  
M. Purgato ◽  
C. Barbui
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Rating Scales ◽  
Rating Scale ◽  
Outcome Data ◽  
Continuous Outcome ◽  
Advantages And Disadvantages ◽  
Continuous Outcomes ◽  
Scale Scores

In psychiatry, the use of rating scales as measures of outcome in clinical trials allows us to generate continuous outcome data, where each individual's outcome is measured in numbers. Continuous outcomes can be divided into two categories, such as improved and not improved, or may be kept continuous. This article briefly presents the main advantages and disadvantages of these two approaches, which are commonly employed in the analyses of rating scale scores in clinical trials and systematic reviews.

AAC Collaboration Using the Self-Anchored Rating Scales (SARS): An Aphasia Case Study

2012 ◽  
Vol 21 (4) ◽  
pp. 136-143
Author(s):  
Lynn E. Fox
Keyword(s):  
Augmentative And Alternative Communication ◽  
Rating Scales ◽  
Rating Scale ◽  
Therapeutic Process ◽  
Family Counseling ◽  
The Self ◽  
Alternative Communication ◽  
Her Family ◽  
Solution Focused

Abstract The self-anchored rating scale (SARS) is a technique that augments collaboration between Augmentative and Alternative Communication (AAC) interventionists, their clients, and their clients' support networks. SARS is a technique used in Solution-Focused Brief Therapy, a branch of systemic family counseling. It has been applied to treating speech and language disorders across the life span, and recent case studies show it has promise for promoting adoption and long-term use of high and low tech AAC. I will describe 2 key principles of solution-focused therapy and present 7 steps in the SARS process that illustrate how clinicians can use the SARS to involve a person with aphasia and his or her family in all aspects of the therapeutic process. I will use a case study to illustrate the SARS process and present outcomes for one individual living with aphasia.

Childbirth and Posttraumatic Stress Responses

2006 ◽  
Vol 22 (4) ◽  
pp. 259-267 ◽  
Author(s):  
Eelco Olde ◽  
Rolf J. Kleber ◽  
Onno van der Hart ◽  
Victor J.M. Pop
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Posttraumatic Stress ◽  
Stress Responses ◽  
Rating Scales ◽  
Rating Scale ◽  
Stress Disorder ◽  
Traumatic Experience ◽  
Event Scale ◽  
Self Rating ◽  
The Impact

Childbirth has been identified as a possible traumatic experience, leading to traumatic stress responses and even to the development of posttraumatic stress disorder (PTSD). The current study investigated the psychometric properties of the Dutch version of the Impact of Event Scale-Revised (IES-R) in a group of women who recently gave birth (N = 435). In addition, a comparison was made between the original IES and the IES-R. The scale showed high internal consistency (α = 0.88). Using confirmatory factor analysis no support was found for a three-factor structure of an intrusion, an avoidance, and a hyperarousal factor. Goodness of fit was only reasonable, even after fitting one intrusion item on the hyperarousal scale. The IES-R correlated significantly with scores on depression and anxiety self-rating scales, as well as with scores on a self-rating scale of posttraumatic stress disorder. Although the IES-R can be used for studying posttraumatic stress reactions in women who recently gave birth, the original IES proved to be a better instrument compared to the IES-R. It is concluded that adding the hyperarousal scale to the IES-R did not make the scale stronger.

D-test: A New Test for Analyzing Scale Invariance Using Symbolic Dynamics and Symbolic Entropy

Methodology ◽  
2011 ◽  
Vol 7 (3) ◽  
pp. 88-95 ◽  
Author(s):  
Jose A. Martínez ◽  
Manuel Ruiz Marín
Keyword(s):  
Symbolic Dynamics ◽  
Scale Invariance ◽  
Rating Scales ◽  
Rating Scale ◽  
Marketing Research ◽  
Response Patterns ◽  
Measurement Scales ◽  
Improve Measurement ◽  
Entropy Measures ◽  
The Difference

The aim of this study is to improve measurement in marketing research by constructing a new, simple, nonparametric, consistent, and powerful test to study scale invariance. The test is called D-test. D-test is constructed using symbolic dynamics and symbolic entropy as a measure of the difference between the response patterns which comes from two measurement scales. We also give a standard asymptotic distribution of our statistic. Given that the test is based on entropy measures, it avoids smoothed nonparametric estimation. We applied D-test to a real marketing research to study if scale invariance holds when measuring service quality in a sports service. We considered a free-scale as a reference scale and then we compared it with three widely used rating scales: Likert-type scale from 1 to 5 and from 1 to 7, and semantic-differential scale from −3 to +3. Scale invariance holds for the two latter scales. This test overcomes the shortcomings of other procedures for analyzing scale invariance; and it provides researchers a tool to decide the appropriate rating scale to study specific marketing problems, and how the results of prior studies can be questioned.

Finding Talent Among Elementary English Learners: A Validity Study of the HOPE Teacher Rating Scale

2021 ◽  
pp. 001698622098594
Author(s):  
Nielsen Pereira
Keyword(s):  
English Language Learners ◽  
English Learners ◽  
English Language ◽  
Rating Scales ◽  
Rating Scale ◽  
Teacher Rating ◽  
Esl Teachers ◽  
Invariance Testing ◽  
Scale Scores ◽  
The One

The purpose of this study was to investigate the validity of the HOPE Scale for identifying gifted English language learners (ELs) and how classroom and English as a second language (ESL) teacher HOPE Scale scores differ. Seventy teachers completed the HOPE Scale on 1,467 students in grades K-5 and four ESL teachers completed the scale on 131 ELs. Measurement invariance tests indicated that the HOPE Scale yields noninvariant latent means across EL and English proficient (EP) samples. However, confirmatory factor analysis results support the use of the scale with ELs or EP students separately. Results also indicate that the rating patterns of classroom and ESL teachers were different and that the HOPE Scale does not yield valid data when used by ESL teachers. Caution is recommended when using the HOPE Scale and other teacher rating scales to compare ELs to EP students. The importance of invariance testing before using an instrument with a population that is different from the one(s) for which the instrument was developed is discussed.

Sign in / Sign up

Export Citation Format

Share Document