Consistency checks to improve measurement with the Montgomery-Asberg Depression Rating Scale (MADRS)

Jonathan Rabinowitz; Nina R Schooler; Brianne Brown; Mads Dalsgaard; Nina Engelhardt; Gretchen Friedberger; Bruce J Kinon; Daniel Lee; Felice Ockun; Atul Mahableshwarkar; Joyce Tsai; Janet B W Williams; Colin Sauder; Christian Yavorsky; ISCTM ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs working group members

doi:10.1016/j.jad.2019.05.077

Consistency checks to improve measurement with the Montgomery-Asberg Depression Rating Scale (MADRS)

J Affect Disord. 2019 Sep 1:256:143-147. doi: 10.1016/j.jad.2019.05.077. Epub 2019 Jun 1.

Authors

Jonathan Rabinowitz¹, Nina R Schooler², Brianne Brown³, Mads Dalsgaard⁴, Nina Engelhardt⁵, Gretchen Friedberger⁶, Bruce J Kinon⁷, Daniel Lee⁸, Felice Ockun⁹, Atul Mahableshwarkar¹⁰, Joyce Tsai¹¹, Janet B W Williams¹², Colin Sauder¹³, Christian Yavorsky¹⁴; ISCTM ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs working group members

Affiliations

¹ Bar Ilan University, Ramat Gan, Israel. Electronic address: jonathan.rabinowitz@biu.ac.il.
² SUNY Downstate Medical Center, 450 Clarkson Avenue, MSC 1203, Brooklyn, NY 11203, United States.
³ Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, United States.
⁴ Lundbeck A/S, Ottiliavej 9, Valby 2500, Denmark.
⁵ Intra-Cellular Therapies, 430 East 29th Street, Suite 900, New York, NY 10016, United States.
⁶ Bracket Global, LLC, PO Box 7137, McLean, VA 22106, United States.
⁷ Lundbeck North America, 6 Parkway North, Suite 400, Deerfield, IL 60015, United States.
⁸ Food and Drug Administration, Division of Psychiatry Products, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, United States.
⁹ Medavante-ProPhase LLC, 3 Park Avenue, New York, NY 10016, United States.
¹⁰ BlackThorn Therapeutics Inc., 780 Brannan St, San Francisco, CA, United States.
¹¹ Sunovion Pharmaceuticals, One Bridge Plaza North, Suite 510, Fort Lee, NJ 07024, United States.
¹² Columbia University Department of Psychiatry c/o 2466 Westlake Ave N., #19, Seattle, WA 98109, United States.
¹³ Adams Clinical, 521 Mt Auburn St, Suite 107, Watertown, MA 02472, United States; UT Health San Antonio, Department of Psychiatry, 7703 Floyd Curl Drive, San Antonio TX 78229, United States.
¹⁴ Cronos CCS, 201 South Main Street, Lambertville, NJ 08530, United States.

PMID: 31176186
DOI: 10.1016/j.jad.2019.05.077

Abstract

International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Montgomery-Asberg Depression Rating Scale (MADRS). Twenty-two flags were identified. Seven flags are believed to be strong flags that suggest that a thorough review of rating is warranted. The flags were applied to assessments derived from the NEWMEDS data repository. Almost 65% of ratings had at least one inconsistency flag raised and 22% had two or more. Application of flags to clinical ratings may improve reliability of ratings and validity of trials.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Depression / diagnosis*
Female
Humans
Male
Middle Aged
Psychiatric Status Rating Scales / standards*
Psychometrics
Reproducibility of Results