P.2.b.049 Increasing signal over noise in MDD clinical trials: improvement after efficacy scale rater training among experienced MDD investigators

2013 ◽  
Vol 23 ◽  
pp. S348
Author(s):  
J. Busner ◽  
A. Kott ◽  
G. Sachs
Keyword(s):  
Clinical Trials ◽  
Rater Training

scholarly journals M42. INDEPENDENT REVIEW & MONITORING IMPROVES QUALITY OF PANSS DATA IN GLOBAL CLINICAL TRIALS

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S150-S150
Author(s):  
Barbara Echevarria ◽  
Cong Liu ◽  
Selam Negash ◽  
Mark Opler ◽  
Patricio Molero ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Quality ◽  
Working Group ◽  
Double Blind Study ◽  
Open Label ◽  
Rater Training ◽  
Double Blind ◽  
Open Label Extension ◽  
Expert Working Group ◽  
Independent Review

Abstract Background The Positive and Negative Syndrome Scale (PANSS) (1) is the most widely used endpoint for measuring change in schizophrenia clinical trials. A set of flags have been developed by ISCTM expert working group to identify potential scoring errors in PANSS assessments (2). Measures have been taken by sponsors (pharmaceutical industry) with the goal of increasing scoring reliability and data quality, such as the use of Independent Review (IRev). We evaluated changes in data quality when site raters stop being recorded and monitored via IRev by comparing two studies with the same cohort of raters, one with independent review and one without. Methods Data from PANSS assessments in two global multisite schizophrenia clinical trials were analyzed. We selected data from raters participating in both studies (which run concurrently for a significant period of time). Raters were rigorously trained on administration and scoring conventions and certified prior to the study through demonstration of adequate interrater reliability. In addition to these steps, raters in study A were required to audio record all PANSS assessments with a selected subset of visits being subject to IRev. PANSS assessments in study B were neither recorded nor monitored via IRev. Data quality after study completion was examined by calculating the frequency of anomalous data patterns identified as “high” (very probable or definite error) by the ISCTM Working Group in both studies. Additionally, we examined the percentage of assessments with lower than expected PANSS interview duration as captured via an eCOA platform. Results There were 9441 eCOA PANSS assessments in study A and 6178 in study B included in this analysis. The proportions of flags that represented highly probable/definite error differed significantly between the studies (9% vs 18% for Study A and B, respectively, p<.01). The most significant differences in ISCTM flags were related to overly consistent scoring patterns (27 or more items scored identically to the prior visit) occurring with higher frequency in study B. Additionally, study B also had a significantly higher frequency of assessments flagged for low interview duration (< 15 minutes) (1% vs 4% for Study A and B, respectively, p<.01). Discussion Initial rater training is necessary but not sufficient to ensure adequate data quality in schizophrenia trials. Implementation of additional in-study oversight through Independent Review or similar methods reduces the probability of data error in PANSS assessments, including the appearance of improbable rating patterns and decreased time spent interviewing study subjects. One potential limitation is that study A is a double-blind study whereas study B is an open label extension of study A.

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.

The impact of rater training on clinical outcomes assessment data: a literature review

2017 ◽  
Vol 4 (3) ◽  
pp. 101 ◽  
Author(s):  
Michael E. Sadler ◽  
Rinah T. Yamamoto ◽  
Laura Khurana ◽  
Susan M. Dallabrida
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Assessment Data ◽  
Rater Training ◽  
Rater Reliability ◽  
Report Data ◽  
Clinical Outcomes Assessment ◽  
Improved Accuracy ◽  
Training Modalities ◽  
The Impact

<p class="abstract"><span lang="EN-IN">Rater training is a well-recognized approach to minimizing inaccuracy and variability in clinical outcomes assessments common in clinical trials. However, there is a dearth of empirical research on the types of rater training and qualifications that contribute to improved accuracy, inter-rater reliability and intra-rater reliability. Herein, we discuss the need for rater training in clinical trials and review publications that report data on rater characteristics, training modalities and outcomes in terms of accuracy and reliability of clinical outcomes data. </span></p><p> </p>

Rater Training in Multicenter Clinical Trials

2004 ◽  
Vol 24 (2) ◽  
pp. 113-117 ◽  
Author(s):  
Kenneth A. Kobak ◽  
Nina Engelhardt ◽  
Janet B.W. Williams ◽  
Joshua D. Lipsitz
Keyword(s):  
Clinical Trials ◽  
Rater Training ◽  
Multicenter Clinical Trials

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

1973 ◽  
Vol 31 ◽  
pp. 404-405
Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Tumor Tissue ◽  
Soft Tissue Tumors ◽  
Clinical Usefulness ◽  
Electron Microscopic ◽  
Normal Cells ◽  
Electron Microscopic Autoradiography ◽  
Peritoneal Cells ◽  
Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

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