Innovations In Clinical Neuroscience

NOV-DEC 2017

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

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81 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE November-December 2017 • Volume 14 • Number 11–12 R E V I E W to the use of the scale, active approaches will be far more effective in highlighting these issues and enabling retention of new concepts and information; 2) evaluations of inter- rater reliability should include a videotaped interview or evaluation of a standardized subject/volunteer; most optimally, certification will involve an assessment of interview technique as well as inter-rater reliability to ensure that all prospective raters are capable of conducting an evaluation that strikes the proper balance of adherence to the interview guide and maintenance of flexibility and clinical research rapport; and lastly 3) following initial training, quality assurance approaches should include ongoing evaluation of data and assessment technique, are employed. Where possible, technology can and should be used to help facilitate these processes. Whether utilizing eCOA to replace paper with electronic forms or driving "targeted calibration" through an analysis of data in-study, a dynamic approach to ensuring inter-rater reliability will help to guarantee that core principles are applied rigorously throughout the study. REFERENCES 1. Sajatovic M, Gaur R, Tatsuoka C, et al. Rater training for a multi-site, international clinical trial: What mood symptoms may be most difficult to rate? Psychopharmacol Bull. 2011;44(3):5–14. 2. Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2): 261–276. 3. Lindström E, Wieselgren IM, von Knorring L. Interrater reliability of the Structured Clinical Interview for the Positive and Negative Syndrome Scale for schizophrenia. Acta Psychiatr Scand. 1994;89(3):192–195. 4. Knorring LV, Lindström E. Principal components and further possibilities with the PANSS. Acta Psychiatrica Scandinavica. 1995;92(s388):5–10. 5. Napo F, Heinz A, Auckenthaler A. Explanatory models and concepts of West African Malian patients with psychotic symptoms. European Psychiatry. 2012;27 Suppl 2:S44–S49. 6. Müller MJ, Wetzel H. Improvement of inter-rater reliability of PANSS items and subscales by a standardized rater training. Acta Psychiatr Scand. 1998;98(2):135–139. 7. Leucht S, Kane JM, Kissling W, et al. What does the PANSS mean? Schizophr Res. 2005;79(2- 3):231–238. 8. van der Gaag M, Cuijpers A, Hoffman T, et al. The five-factor model of the Positive and Negative Syndrome Scale I: confirmatory factor analysis fails to confirm 25 published five-factor solutions. Schizophr Res. 2006;85(1-3):273–297. 9. Kobak KA, Feiger AD, Lipsitz JD. Interview quality and signal detection in clinical trials. Am J Psychiatry. 2005;162(3):628. 10. Tolley C, Rofail D, Gater A, Lalonde JK. The feasibility of using electronic clinical outcome assessments in people with schizophrenia and their informal caregivers. Patient Relat Outcome Meas. 2015;6:91–101. 11. Kobak K, Opler M, Engelhardt N. PANSS rater training using Internet and videoconference: results from a pilot study. Schizophr Res. 2007;92(1-3):63–67. 12. Shen J, Kobak KA, Zhao Y, et al. Use of remote centralized raters via live 2-way video in a multicenter clinical trial for schizophrenia. J Clin Psychopharmacol. 2008;28(6):691–693. 13. Alphs L, Benedetti F, Fleischhacker W, Kane J. Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it?. Int J Neuropsychopharmacol. 2012;15(7):1003–1014. 14. Rabinowitz J, Schooler N, Anderson A, et al. Consistency checks to improve measurement with the Positive and Negative Syndrome Scale (PANSS). Schizophr Res. 2017 Mar 8. pii: S0920–9964(17)30141-X. 15. Daniel D, Kalali A, West M, et al. Data quality monitoring in clinical trials: Has it been worth it? an evaluation and prediction of the future by all stakeholders. Innov Clin Neurosci. 2016;13(1–2): 27–33. 16. Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry. 1997;58(12):538–546. 17. Kott A, Daniel DG. Effects of PANSS audio/ video recordings on the presence of identical scorings across visits. Eur Neuropsychopharmacol. 2015;25:S543–S544. ICNS

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