The Evaluation of Negative Symptoms by Videoconferencing in a Clinical Trial

Williams, JBW 1,2 Popp, D1 Osman, DA1 Cohen, EA1 Detke, MJ 1,3 1MedAvante, Inc. 2Department of Psychiatry, Columbia University 3Indiana University School of Medicine

©2013 MedAvante Inc.RESEARCH INSTITUTE

PANSS Negative Scale

N1. Blunted affect

N2. Emotional withdrawal

N3. Poor rapport

N4. Passive/apathetic social withdrawal

N5. Difficulty in abstract thinking

N6. Lack of spontaneity

N7. Stereotyped thinking

NSA-16 Items

1. Prolonged time to respond

2. Restricted speech quantity

3. Impoverished speech quantity

4. Inarticulate speech

5. Emotion: reduced range

6. Affect: reduced modulation

7. Affect: reduced display

8. Reduced social drive

9. Poor rapport w/interviewer

10. Reduced sexual interest

11. Poor grooming/hygiene

12. Reduced sense of purpose

13. Reduced hobbies/interests

14. Reduced daily activity

15. Reduced expressive gestures

16. Slow movements

PANSS Marder Negative Symptoms Factor

N1. Blunted affect

N2. Emotional withdrawal

N3. Poor rapport

N4. Passive/apathetic social withdrawal

N6. Lack of spontaneity

G7. Motor retardation

G16. Active social avoidance

Negative Symptom Items Across Scales

Interrater ReliabilityOne measure of the reliability of a scale is the degree to which different raters can assign similar scores to the same phenomena using the same scale. ICCs range from 0-1.0, with .9 or above being excellent.

• All scales showed excellent interrater reliability between raters and trainers.

Convergent and Discriminant Validity – Subscale CorrelationsTo be useful, a scale must have convergent validity (high correlation with other scales that measure the same construct) and divergent validity (relatively low correlations with other scales that measure different constructs).

• As expected, the NSA-16 correlates highest with the PANSS Marder and PANSS negative subscales, and is negatively correlated with the PANSS positive subscale.

Variable Cronbach’s AlphaNSA .88PANSS Marder .76PANSS Negative .71PANSS Total .84

PANSS Positive .72PANSS General .76

Variable CorrelationsPANSS Marder .84***PANSS Negative .85***PANSS Total .43***PANSS Positive - .020PANSS General .232**

***p < .001, **p <.01

Variable ICCNSA .99

PANSS Marder .97PANSS Negative .97

PANSS Total .98

PANSS Positive .95PANSS General .98N = 65 pairs

RESULTS

• Mean duration of PANSS = 36 min (SD = 15); mean duration NSA-16 = 16 min (SD = 7).

• All total and subscale scores were normally distributed at screening (all skewness < +/-.34; all kurtosis < +/- .91).

Inter-item Correlations for the PANSS Negative Scale, NSA-16 Scale, and PANSS Marder Negative Symptoms Factor *

PANSS Negative Subscale Item

Blunted Affect (N1)

Emotional Withdrawal (N2)

Poor Rapport (N3)

Passive/Apathetic Social Withdrawal (N4)

Lack of Spontaneity and Flowof Conversation (N6)

Additional PANSSMarder NegativeSymptoms Factor Items

Motor Retardation (PANSS G7)

Active Social Avoidance (PANSS G16)

NSA-16 Item

Affect - Reduced Modulation of Intensity (6)Affect - Reduced Display on Demand (7)Reduced Expressive Gestures (15)

Reduced Social Drive (8)Reduced Hobbies and Interest (13)Reduced Daily Activity (14)

Poor Rapport with Interviewer (9)

Reduced Social Drive (8) Reduced Daily Activity (14)

Prolonged Time to Respond (1)Restricted Speech Quantity (2)Impoverished Speech Content (3)

NSA-16 Item

Slowed Movements (16)

Reduced Social Drive (8) Reduced Daily Activity (14)

Correlations

.87***

.53***

.80***

.56***

.43***

.43***

.86***

.55***

.42***

.46***

.88***

.49***

Correlations

.83***

.32***

.25***

Internal Consistency Reliability

Cronbach’s alpha is an indicator of scale reliability in that it examines the correlations among different items in a scale to see to what extent they measure the same construct. Cronbach’s alpha ranges from 0-1.0, with .7-.8 indicating acceptable to good internalconsistency.

• All scales showed acceptable to good internal consistency. Cronbach’s alpha was higher for the NSA-16 than for the PANSS Negative or PANSS Marder subscales.

DISCUSSION AND CONCLUSIONS

The high total and item-level ICCs, good internal consistency of each of the scales, and the high inter-item correlations across scales, suggest that negative symptoms can be rated very reliably by videocon- ferencing using well-calibrated blinded independent raters. In addition, the high convergent and discriminant validity suggest that negative symptoms can be validly rated by videoconferencing using well-calibrated raters. This facilitates the use of blinded independent raters in clinical trials. The PANSS and NSA-16 in this study were not administered totally independent of one another, and this puts a limit on a comparison of the PANSS-Negative and Marder subscales and the NSA-16.

ReferencesAlphs LD, Summerfelt A, Lann H, Muller RJ. 1989. The negative symptom assessment: A new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull; 25(2):159-63. Sharp IR, Kobak KA, Osman DA. 2011. The use of videoconferencing with patients with psychosis: a review of the literature. Ann Gen Psychiatry; 10(14). Yoshino A, Shigemura J, Kobayashi Y, Nomura S, Shishikura K, Den R, Wakisaka H, Kamata S, Ashida H. 2001. Telepsychiatry: Assessment of televideo psychiatric interview reliability with present- and next-generation internet infrastructures. Acta Psychiatr Scand; 104:223–226. Zarate CA Jr, Weinstock L, Cukor P, Morabito C, Leahy L, Burns C, Baer L. 1997. Applicability of telemedicine for assessing patients with schizophrenia: Acceptance and reliability. J Clin Psychiatry; 58:1, 22–25. One or more authors report potential conflicts which are described in the program.

*PANSS Negative Symptom scale items N5. Difficulty in Abstract Thinking and N7. Stereotyped Thinking are not included because they did not correlate significantly with any NSA item.***p < .001

BACKGROUND

• Negative symptoms in Schizophrenia are of increasing interest because they are not adequately treated by available medications.

• Assessment instruments include the Negative Symptom Assessment (NSA-16), (Alphs et al, 1989), the PANSS negative symptom subscale, and the PANSS Marder negative symptoms factor. Assessment of patients with Schizophrenia by video conferencing has been shown to yield results equivalent to those obtained when the scale is administered face-to-face (Zarate et al, 1997; Yoshino et al, 2001; Sharp et al, 2011).

• Videoconferencing facilitates the use of independent remote raters.

• Advantages of independent remote raters may include blinding to protocol details and visit number, which may eliminate enrollment and expectation biases.

• A smaller cohort of raters can be continuously calibrated with trainers observing interviews live by 3-way videoconferencing.

• This poster addresses how well negative symptoms can be assessed by videoconferencing.

METHODS

• 225 subjects with Schizophrenia in a ran- domized clinical trial.

• All subjects were inter- viewed by live two-way videoconferencing at screen, baseline, 11 more visits over 36 weeks, and at end point or 1 year (14 visits altogether).

• PANSS and NSA-16 were administered at all visits (n=1122). NSA immediately followed PANSS.

• 17 blinded independent central raters.

• Central raters were uniformly trained according to training and calibration plans which involved thorough initial didactic and applied training and ongoing monitoring to ensure standardization and to prevent drift.

• 65 NSA-16 and 68 PANSS interviews were observed and independently rated by a senior clinician as a quality control measure.

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