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Consistency checks to improve measurement with the Hamilton Rating Scale for Anxiety (HAM-A)
J. Rabinowitz, JBW. Williams, N. Hefting, A. Anderson, B. Brown, DJ. Fu, B. Kadriu, A. Kott, A. Mahableshwarkar, J. Sedway, D. Williamson, C. Yavorsky, NR. Schooler
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články
- MeSH
- lidé MeSH
- psychiatrické posuzovací škály MeSH
- psychometrie MeSH
- reprodukovatelnost výsledků MeSH
- úzkost * MeSH
- úzkostné poruchy * diagnóza farmakoterapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response. METHODS: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed consistency checks for ratings of the Hamilton Anxiety Rating Scale (HAM-A) and Clinical Global Impression of Severity of anxiety (CGIS) that are widely used in studies of mood and anxiety disorders. Flags were applied to 40,349 HAM-A administrations from 15 clinical trials and to Monte Carlo-simulated data as a proxy for applying flags under conditions of inconsistency. RESULTS: Thirty-three flags were derived these included logical consistency checks and statistical outlier-response pattern checks. Twenty-percent of the HAM-A administrations had at least one logical scoring inconsistency flag, 4 % had two or more. Twenty-six percent of the administrations had at least one statistical outlier flag and 11 % had two or more. Overall, 35 % of administrations had at least one flag of any type, 19 % had one and 16 % had 2 or more. Most of 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. Flags can be used for monitoring of raters during an ongoing trial and as part of post-trial evaluation. Appling flags may improve reliability and validity of trial data.
ARM Pharma Consulting Deerfield MI USA
Bar Ilan University Ramat Gan Israel
Columbia University Department of Psychiatry c o 2466 Westlake Ave N 19 Seattle WA 98109 USA
Janssen Research and Development 3210 Merryfield Row San Diego CA 92121 United States
Janssen Scientific Affairs LLC 1125 Trenton Harbourton Rd Titusville NJ 08560 USA
Lundbeck A S Ottiliavej 9 2500 Valby Denmark
Signant Health Prague Czech Republic
SUNY Downstate Medical Center 450 Clarkson Avenue MSC 1203 Brooklyn NY 11203 USA
Citace poskytuje Crossref.org
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- $a BACKGROUND: Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response. METHODS: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed consistency checks for ratings of the Hamilton Anxiety Rating Scale (HAM-A) and Clinical Global Impression of Severity of anxiety (CGIS) that are widely used in studies of mood and anxiety disorders. Flags were applied to 40,349 HAM-A administrations from 15 clinical trials and to Monte Carlo-simulated data as a proxy for applying flags under conditions of inconsistency. RESULTS: Thirty-three flags were derived these included logical consistency checks and statistical outlier-response pattern checks. Twenty-percent of the HAM-A administrations had at least one logical scoring inconsistency flag, 4 % had two or more. Twenty-six percent of the administrations had at least one statistical outlier flag and 11 % had two or more. Overall, 35 % of administrations had at least one flag of any type, 19 % had one and 16 % had 2 or more. Most of 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. Flags can be used for monitoring of raters during an ongoing trial and as part of post-trial evaluation. Appling flags may improve reliability and validity of trial data.
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