Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program

Clinical ascertainment and clinical outcome are key features of any large multisite study. In the ProNET and PRESCIENT research networks, the Accelerating Medicines Partnership<sup>®</sup> Schizophrenia (AMP<sup>®</sup>SCZ) Clinical Ascertainment and Outcome Measures Team aimed to establish a harmonized clinical assessment protocol across these two research networks and to define ascertainment criteria and primary and secondary endpoints. In addition to developing the assessment protocol, the goals of this aspect of the AMP SCZ project were: (1) to implement and monitor clinical training, ascertainment of participants, and clinical assessments; (2) to provide expert clinical input to the Psychosis Risk Evaluation, Data Integration and Computational Technologies: Data Processing, Analysis, and Coordination Center (PREDICT-DPACC) for data collection, quality control, and preparation of data for the analysis of the clinical measures; and (3) to provide ongoing support to the collection, analysis, and reporting of clinical data. This paper describes the (1) protocol clinical endpoints and outcomes, (2) rationale for the selection of the clinical measures, (3) extensive training of clinical staff, (4) preparation of clinical measures for a multisite study which includes several sites where English is not the native language; and (5) the assessment of measure stability over time in the AMP SCZ observational study comparing clinical ratings at baseline and at the 2-month follow up. Watch Dr. Jean Addington discuss her work and this article: https://vimeo.com/1040425281 .

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Publication Details

Journal
Schizophrenia
Published
2025-04-03
DOI
https://doi.org/10.1038/s41537-025-00556-7
Citations
9
Primary Topic
Schizophrenia research and treatment
Type
article
Field-Weighted Citation Impact
13.24

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article

Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program

Michael J. Coleman, Heather M. Wastler, Sylvain Bouix, Celso Arango et al.
9 citations
Schizophrenia
Schizophrenia research and treatment
13.24
article

Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program

Michael J. Coleman, Heather M. Wastler, Sylvain Bouix, Celso Arango, Barbara A. Cornblatt, John M. Kane, Diana O. Perkins, Lu Liu, Nora Penzel, Jai L. Shah, Dominic Oliver, Albert R. Powers, Godfrey D. Pearlson, Catalina Mourgues, Carrie E. Bearden, Fred W. Sabb, Kerstin Langbein, Nicholas J. K. Breitborde, Jason Eric Schiffman, Gregory P. Strauss, Jijun Wang, Philippe Conus, Daniel H. Mathalon, Luis Alameda, Lana Kambeitz‐Ilankovic, Jun Soo Kwon, Dominic Dwyer, René S. Kahn, Matthew R. Broome, Melissa Kerr, Covadonga M. Díaz‐Caneja, Merete Nordentoft, Amy Braun, Steven M. Silverstein, Carla Gerber, Ricardo E. Carrión, Christy Lai Ming Hui, Barnaby Nelson, Andrea M. Auther, Pablo A. Gaspar, Judy L. Thompson, Jean Addington, Cheryl M. Corcoran, Jesús Pérez, Rachel Upthegrove, William S. Stone, Patrick D. McGorry, Kathryn E. Lewandowski, Paolo Fusar‐Poli, Monica E. Calkins, Kate Buccilli, Scott W. Woods, Jack D. Rogers, Stefan Smesny, Kristin S. Cadenhead, Patricia Marcy, Martha E. Shenton, Daniel H. Wolf, Grace R. Jacobs, Joseph Kambeitz, Andrew Thompson, Vijay Anand Mittal, Leslie E. Horton, Masoomeh Faghankhani, Nikolaos Koutsouleris, Sung‐Wan Kim, Eric Yu Hai Chen, Swapna Verma, Jimmy Choi, Louise Birkedal Glenthøj, Alana Wickham, Ángela Núñez, Barbara C. Walsh, Matcheri S. Keshavan, Lauren M. Ellman, Inge Winter‐van Rossum, Ofer Pasternak
article en
9 citations

Abstract

Clinical ascertainment and clinical outcome are key features of any large multisite study. In the ProNET and PRESCIENT research networks, the Accelerating Medicines Partnership<sup>®</sup> Schizophrenia (AMP<sup>®</sup>SCZ) Clinical Ascertainment and Outcome Measures Team aimed to establish a harmonized clinical assessment protocol across these two research networks and to define ascertainment criteria and primary and secondary endpoints. In addition to developing the assessment protocol, the goals of this aspect of the AMP SCZ project were: (1) to implement and monitor clinical training, ascertainment of participants, and clinical assessments; (2) to provide expert clinical input to the Psychosis Risk Evaluation, Data Integration and Computational Technologies: Data Processing, Analysis, and Coordination Center (PREDICT-DPACC) for data collection, quality control, and preparation of data for the analysis of the clinical measures; and (3) to provide ongoing support to the collection, analysis, and reporting of clinical data. This paper describes the (1) protocol clinical endpoints and outcomes, (2) rationale for the selection of the clinical measures, (3) extensive training of clinical staff, (4) preparation of clinical measures for a multisite study which includes several sites where English is not the native language; and (5) the assessment of measure stability over time in the AMP SCZ observational study comparing clinical ratings at baseline and at the 2-month follow up. Watch Dr. Jean Addington discuss her work and this article: https://vimeo.com/1040425281 .

SchizophreniaVol. 11(1)
Northwestern University (US), University of North Carolina at Chapel Hill (US), University of Copenhagen (DK), Brigham and Women's Hospital (US), Northwell Health (US), Beth Israel Deaconess Medical Center (US), Feinstein Institute for Medical Research (US), Harvard University (US), Seoul National University (KR), Deakin University (AU), University of California, Los Angeles (US), University of Georgia (US), The University of Melbourne (AU), University of Calgary (CA), University of Pittsburgh (US), Nanyang Technological University (SG), Douglas College (CA), University of California, San Francisco (US), University of Cologne (DE), University of Oregon (US), King's College London (GB), Universidad de Salamanca (ES), University of California, Irvine (US), Washington University in St. Louis (US), Gwangju Health University (KR), University of Pavia (IT), Manchester Academic Health Science Centre (GB), Mental Health Services (DK), Copenhagen University Hospital (DK), Shanghai Mental Health Center (CN), University of Manchester (GB), University of Rochester Medical Center (US), Hospital General Universitario Gregorio Marañón (ES), Yale University (US), University of California San Diego (US), Massachusetts General Hospital (US), Chonnam National University Hospital (KR), Hôpital de Cery (CH), Donald & Barbara Zucker School of Medicine at Hofstra/Northwell (US), Orygen (AU), Hôpital Orthopédique de la Suisse Romande (CH), King's College School (GB), Instituto de Investigación Biomédica de Salamanca (ES), Jena University Hospital (DE), Behavioral Health Network (US), Institute of Mental Health (SG), San Francisco VA Health Care System (US), Cambridgeshire and Peterborough NHS Foundation Trust (GB), University Hospital Cologne (DE), Birmingham Women’s and Children’s NHS Foundation Trust (GB), Connecticut Mental Health Center (US), Hotchkiss Brain Institute (CA), McGill University (CA), The Ohio State University (US), University of Chile (CL), University of Pennsylvania (US), University of Birmingham (GB), Ludwig-Maximilians-Universität München (DE), Temple University (US), University of Hong Kong (HK), École de Technologie Supérieure (CA), Icahn School of Medicine at Mount Sinai (US)
National Institute of Mental Health
Partnerships for the goals
Openalex Percentile: Top 1%
Schizophrenia research and treatment
13.24
DOIOpen Access PDFOpenAlex
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