Innovations In Clinical Neuroscience

NOV-DEC 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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77 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE November-December 2017 • Volume 14 • Number 11–12 R E V I E W R Rater training helps to ensure reliability in measurement throughout the course of a clinical trial. Precision in the use of a rating scale is important primarily because statistical power to detect differences between treatment groups increases proportionally to inter-rater reliability. A related secondary objective is to ensure that when scale items or subscale score thresholds are being incorporated as inclusion criteria, all raters in a study can reliably classify subjects. Rater training further enhances precision by standardizing interview procedures and codifying the principles of use for a given scale across raters, sites, and regions. 1 The Positive and Negative Syndrome Scale (PANSS) has several complex features and requires a thorough and structured approach to rater training. 1 Compared with rating scales developed for other disorders, the PANSS has many items, evaluates a multidimensional array of symptoms (e.g. positive, negative, neuromotor, depressive), and involves the use of data from patient reports, caregiver reports, and clinical observations. Consequently, the PANSS takes up more time during training and requires a greater amount of time for one to master it compared to many other instruments. As described in the original 1987 publication, 2 each PANSS item contains three elements that must be used correctly in order to ensure that reliability and validity are maintained: 1 1) The item definition describes the construct under evaluation; 2) Each item contains a detailed description of the basis for rating that indicates the sources of information intended to be used for each item. These sources include observations made during the interview, the patient verbal report, and/ or corroborative information obtained from caregivers about symptoms and behaviors during the reference period prior to the assessment; and 3) Each item includes a set of carefully written anchors for each level of severity, from 1 (absent) to 7 (extreme). CORE PRINCIPLES IN THE USE OF THE PANSS Several approaches to the use of the PANSS might help raters and those leading training programs to achieve a high degree of reliability. Four core principles, summarized here, are taken from publications and lectures given by Dr. Lewis Opler over the course of many years. We summarize them briefly here so as to provide guidance to individual raters A B S T R A C T ABSTRACT: Rater training and the maintenance of the consistency of ratings are critical to ensuring reliability of study measures and sensitivity to changes in the course of a clinical trial. The Positive and Negative Syndrome Scale (PANSS) has been widely used in clinical trials of schizophrenia and other disorders and is considered the "gold standard" for assessment of antipsychotic treatment efficacy. The various features associated with training and calibration of this scale are complex, reflecting the intricacy and heterogeneity of the disorders that the PANSS is used to evaluate. In this article, the authors review the methods for ensuring reliability of the PANSS as well as a proposed trajectory for its use in the future. An overview of the current principles, implementation, technologies, and strategies for the best use of the PANSS; tips for how to achieve consistency among raters; and optimal training practices of this instrument are presented. KEYWORDS: Positive and Negative Syndrome Scale, PANSS, rater, rater training, technology, clinical trials Positive and Negative Syndrome Scale (PANSS) Training: Challenges, Solutions, and Future Directions by MARK G. A. OPLER, PhD, MPH; CHRISTIAN YAVORSKY, PhD; and DAVID G DANIEL, MD Dr. Opler is Adjunct Assistant Professor at NYU School of Medicine and Chief Research Officer at MedAvante-ProPhase Inc. in New York, New York. Dr. Yavorsky is Chief Scientific Officer and Clinical Director at Cronos Clinical Consulting in Lambertville, New Jersey. Dr. Daniel is Chief Medical Director and Senior Vice President of Bracket Global, LLC and Clinical Professor at George Washington University, in Washington, DC. Innov Clin Neurosci. 2017;14(11–12):77–81 FUNDING: No funding was provided for this article. DISCLOSURES: Dr. Opler is a full-time employee and shareholder of MedAvante-ProPhase Inc. Dr. Yavorsky is a full-time employee of Cronos CCS. Dr. Daniel is a full-time employee and shareholder of Bracket Global, LLC. CORRESPONDENCE: Mark Opler PhD, MPH; Email: mgo4@caa.columbia.edu

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