BACKGROUND: Symptom manifestations in mood disorders can be subtle. Cumulatively, small imprecisions in measurement can limit our ability to measure treatment response accurately. Logical and statistical consistency checks between item responses (i.e., cross-sectionally) and across administrations (i.e., longitudinally) can contribute to improving measurement fidelity. METHODS: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled flags indicating consistency/inconsistency ratings for the Hamilton Rating Scale for Depression (HAM-D17), a widely-used rating scale in studies of depression. Proposed flags were applied to assessments derived from the NEWMEDS data repository of 95,468 HAM-D administrations from 32 registration trials of antidepressant medications and to Monte Carlo-simulated data as a proxy for applying flags under conditions of known inconsistency. RESULTS: Two types of flags were derived: logical consistency checks and statistical outlier-response pattern checks. Almost thirty percent of the HAMD administrations had at least one logical scoring inconsistency flag. Seven percent had flags judged to suggest that a thorough review of rating is warranted. Almost 22% of the administrations had at least one statistical outlier flag and 7.9% had more than one. Most of the administrations in the Monte Carlo- simulated data raised multiple flags. LIMITATIONS: Flagged ratings may represent less-common presentations of administrations done correctly. CONCLUSIONS: Application of flags to clinical ratings may aid in detecting imprecise measurement. Reviewing and addressing these flags may improve reliability and validity of clinical trial data.

Bar Ilan University Ramat Gan Israel

Department of Psychiatry and Biobehavioral Sciences UCLA 760 Westwood Plaza Ste 28 224 Los Angeles CA 90095 United States

Department of Psychiatry Columbia University c o 2466 Westlake Ave N 19 Seattle WA 98109 United States

Emalex Biosciences Inc 330N Wabash Suite 3500 Chicago IL 60611 United States

Janssen Research and Development 3210 Merryfield Row San Diego CA 92121 United States

Janssen Scientific Affairs LLC 1125 Trenton Harbourton Rd Titusville NJ 08560 United States

Janssen Scientific Affairs LLC 1125 Trenton Harbourton Rd Titusville NJ 08560 United States; Department of Psychiatry and Health Behavior Medical College of Georgia at Augusta University Augusta GA 30912 United States

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Signant Health Prague Czech Republic

SUNY Downstate Health Sciences Center 450 Clarkson Avenue MSC 1203 Brooklyn NY 11203 United States

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