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Scheduled Measurement System - Measures
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Various questionnaires, rating scales and visual analog scales (VAS) for study-specific subjective measures can be incorporate into the computerized pharmacodynamic assessment.
Sample Questionnaires and Rating Scales used with DL-SMS
Visual Analog Scales (VAS)
Addiction Research Center Inventory (ARCI)
Leeds Sleep Evaluation Questionnaire (LSEQ)
Subjective Drug Value Test
Beck Depression Inventory –Second Edition (BDI-II)
Beck Anxiety Inventory (BAI)
Various neurocognitive tests and questionnaires are available through our proprietary computerized battery for pharmacodynamic assessment, DecisionLine's Scheduled Measurement System - DL-SMS. Cognitive functions such as psychomotor speed, simple and choice reaction times; visual-manual coordination; attention, working memory, verbal and non-verbal learning and memory, as well as executive functions can be assessed through DL-SMS. In addition, we can incorporate specific tests from other providers such as CANTAB to work with the unique front-end system of DL-SMS in order to meet the needs of early phase trials.
Sample DL-SMS Assessment Battery
Choice Reaction Time (CRT)
Divided Attention (DA)
Digit Symbol Substitution Test (DSST)
Digit Vigilance (DV)
Delayed Word Recognition (DWR)
Sternberg Short-Term Memory (STM)
Additional computerized pharmacodynamic measures are available through independent test procedures such as CANTAB and CogState.
Other Measures of CNS Function
Commercially available equipment, instruments, or software can be integrated directly into DL-SMS for seamless scheduling and collection of pharmacodynamic data such as sensitivity of the visual system to stimulation, postural stability, and pupil size.
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Measure
The questionnaires, as modified for DL-SMS, include:
- Addiction Research Center Inventory (ARCI) short-form
- Profile of Mood States (POMS)
- Subjective Opiate Withdrawal Scales (SOWS)
- Objective Opiate Withdrawal Scales (OOWS)
- Leeds Sleep Evaluation Questionnaire (LSEQ)
- Various VAS scales (Bond and Lader 1974 and others)
Procedure
Participants are presented with a sequence of items, each with a solution set.
Measure Outcome
Responses by a participant are recorded and may be scored and used by DL-SMS to generate data
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Measure
Psychomotor speed
Procedure
The subject attempts to quickly press the buttons indicated on a screen image of the keypad, where the number of alternative choices increases over blocks of responses in each cycle.
Measure Outcome
Reaction time and accuracy of responses
Measure
Manual-tracking task with a simultaneous visual target detection
Procedure
The subject is presented with the image of an airplane and a randomly curving road. As the road moves down the screen, the subject is to try and position the image of the airplane over the center of the road. At random times during this process, a visual target will present itself at random positions on the screen and immediately disappear. The subject is to respond to the visual target as fast as possible by pressing a button on the joystick.
Measure Outcome
Subject's ability to keep the image of the plane over the road and the subject's ability to respond to the visual target (e.g. target "hits", "misses" and "false alarms")
Measure
Speed and visual-motor coordination
Procedure
Using a mouse, the subject attempts to reproduce the symbol (a connected subset of squares from a 3x3 grid) corresponding to each of a series of digits, where the digit-symbol association displayed at the top of the screen varies from cycle to cycle.
Measure Outcome
Number of symbols attempted and the number of symbols completed correctly
Measure
Sustained attention or vigilance
Procedure
The subject views a series of digits, presented one at a time, and attempts to respond whenever a target subsequence (such as 2-4-6) has just been displayed.
Measure Outcome
Measure of accuracy (d'), mean latency of "hits", and the slopes of these statistics over 1-minute intervals of test time
Measure
Verbal declarative memory
Procedure
Subject classifies words by categories, participates in some intervening other tasks, and then attempts to recognize the categorized words versus distractors taken from the same categories.
Measure Outcome
Speed and correctness of responses
Measure
Short-term storage capacity and working memory
Procedure
Subject attempts to memorize a briefly and sequentially displayed list of 2 to 6 digits and then classifies each of a series of digits as contained or not contained in that list, where the list size increases over blocks of response in each cycle.
Measure Outcome
Accuracy and mean reaction time, and the slope of the functions relating reaction time to the target list size
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Measure
Sensitivity of visual system to stimulation; pharmacological effects on CNS
Procedure
The Flicker Fusion device collects flicker fusion thresholds, or the minimum flicker rate that a subject can perceive. The method of limits is used to determine the threshold and both ascending and descending series of trials are used. For the ascending trials, the starting frequency is low and increases in small steps until the participant indicates by pressing the clicker when the participant can no longer perceive the flicker. For the descending runs, the trials start at a high flicker frequency, which appears as a constant source of illumination and then decreases in small steps until the participant indicates that the participant first perceives flicker. All participant responses are recorded in Hertz (Hz).
Measure Outcome
An average or numerical estimate of the mean absolute threshold is computed by taking the average of the flicker frequencies of the various ascending and descending trials
Measure
Body sway and postural stability
Procedure
DL-SMS is programmed to collect two sets of data with the participant standing on the AccuSway platform over predefined period of time, first with the eyes open and then with eyes closed. Experiment parameters can be modified using trial configuration files for the Balance Clinic software. After the data collection is complete the data file is exported to DL-SMS.
Measure Outcome
Postural stability data
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