Application of External Review for Subject Selection in a Schizophrenia Trial

Targum, Steven D.; Little, Jessica A.; López, Enrique; DeMartinis, Nicholas; Rapaport, Mark Hyman; Ereshefsky, Larry

doi:10.1097/jcp.0b013e318248da90

Cited by 12 publications

(12 citation statements)

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“…The idea that two separate assessments of the same subject can improve reliability and reduce methodological errors in clinical trials is not a new concept and has been applied by other investigators [13,14]. A dual affirmation strategy improves subject selection and may optimize trial outcomes [18,31,37].…”

Section: Discussionmentioning

confidence: 99%

“…Each C-VISA TM included a battery of assessment components: [31] In each study, the customized C-VISA TM summary worksheet required documentation to affirm that the subject was truly appropriate (valid) for the specific study and met the following validity criteria: Clinical relevance, as noted above, meant that the presenting symptoms had some pathological impact and were therefore consequential to the subject's behavior or function. In studies involving psychosis or cognitive impairment, the documentation of clinical relevance required collateral information and/or corroboration from a reliable informant.…”

Section: Development Of the C-visa Tmmentioning

confidence: 99%

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Site-independent confirmation of subject selection for CNS trials: ‘dual’ review using audio-digital recordings

Targum

Pendergrass

2014

Ann Gen Psychiatry

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Section: Discussionmentioning

confidence: 99%

Section: Development Of the C-visa Tmmentioning

confidence: 99%

Site-independent confirmation of subject selection for CNS trials: ‘dual’ review using audio-digital recordings

Targum

Pendergrass

2014

Ann Gen Psychiatry

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“…Recently, surveillance strategies using site-independent raters have been used in clinical trials in an attempt to assure instudy ratings quality and enhance precision throughout the trial (Shen et al, 2008;Schoemaker et al, 2009;Sharp et al, 2011;. Site-independent scoring, including video-conferencing and secondary telephone interviews have been used in the assessment of patients with schizophrenia as well (Zarate et al, 1997;Shen et al, 2008;Schoemaker et al, 2009;Sharp et al, 2011;Targum et al, 2012). Each surveillance strategy has potential benefits and inherent limitations (Sharp et al, 2011;.…”

Section: Introductionmentioning

confidence: 98%

Impact of BPRS interview length on ratings reliability in a schizophrenia trial

Targum¹,

Pendergrass²,

Toner³

et al. 2015

European Neuropsychopharmacology

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Signal detection in clinical trials relies on ratings reliability. We conducted a reliability analysis of site-independent rater scores derived from audio-digital recordings of site-based rater interviews of the structured Brief Psychiatric Rating Scale (BPRS) in a schizophrenia study. "Dual" ratings assessments were conducted as part of a quality assurance program in a 12-week, double-blind, parallel-group study of PF-02545920 compared to placebo in patients with sub-optimally controlled symptoms of schizophrenia (ClinicalTrials.gov identifier NCT01939548). Blinded, site-independent raters scored the recorded site-based BPRS interviews that were administered in relatively stable patients during two visits prior to the randomization visit. We analyzed the impact of BPRS interview length on "dual" scoring variance and discordance between trained and certified site-based raters and the paired scores of the independent raters. Mean total BPRS scores for 392 interviews conducted at the screen and stabilization visits were 50.4±7.2 (SD) for site-based raters and 49.2±7.2 for site-independent raters (t=2.34; p=0.025). "Dual" rated total BPRS scores were highly correlated (r=0.812). Mean BPRS interview length was 21:05±7:47min ranging from 7 to 59min. 89 interviews (23%) were conducted in less than 15min. These shorter interviews had significantly greater "dual" scoring variability (p=0.0016) and absolute discordance (p=0.0037) between site-based and site-independent raters than longer interviews. In-study ratings reliability cannot be guaranteed by pre-study rater certification. Our findings reveal marked variability of BPRS interview length and that shorter interviews are often incomplete yielding greater "dual" scoring discordance that may affect ratings precision.

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“…One method to evaluate ratings reliability is to examine ratings precision (reproducibility of the same assessment) by using two independent raters to assess the same patient. We have adopted this two-rater strategy and explored the utility of "dual" (paired) scoring by using blinded, site-independent raters to score audio-digital recordings of site-based interviews in studies of Major Depressive Disorder (MDD) and schizophrenia (Asgharnejad et al, 2012;Targum et al, 2012;Leigh-Pemberton et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

Audio-digital recordings used for independent confirmation of site-based MADRS interview scores

Targum¹,

Pendergrass²,

Toner³

et al. 2014

European Neuropsychopharmacology

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Signal detection requires ratings reliability throughout a clinical trial. The confirmation of site-based rater scores by a second, independent and blinded rater is a reasonable metric of ratings reliability. We used audio-digital pens to record site-based interviews of the Montgomery-Asberg Depression Rating Scale (MADRS) in a double-blind, placebo controlled trial of a novel antidepressant in treatment resistant depressed patients. Blinded, site-independent raters generated "dual" scores that revealed high correlations between site-based and site-independent raters (r=0.940 for all ratings) and high sensitivity, specificity, predictive values, and kappa coefficients for treatment response and non-response outcomes using the site-based rater scores as the standard. The blinded raters achieved an 89.4% overall accuracy and 0.786 kappa for matching the treatment response or non-response outcomes of the site-based raters. A limitation of this method is that independent ratings depend on the quality of site-based interviews and patient responses to the site-based interviewers. Nonetheless, this quality assurance strategy may have broad applicability for studies that use subjective measures and wherever ratings reliability is a concern. "Dual" scoring of recorded site-based ratings can be a relatively unobtrusive surveillance strategy to confirm scores and to identify and remediate rater "outliers" during a study.

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Application of External Review for Subject Selection in a Schizophrenia Trial

Cited by 12 publications

References 4 publications

Site-independent confirmation of subject selection for CNS trials: ‘dual’ review using audio-digital recordings

Site-independent confirmation of subject selection for CNS trials: ‘dual’ review using audio-digital recordings

Impact of BPRS interview length on ratings reliability in a schizophrenia trial

Audio-digital recordings used for independent confirmation of site-based MADRS interview scores

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