Clinical considerations for the inclusion of individuals with autism spectrum disorder in clinical trials.

Diagnoses of autism spectrum disorder (ASD) have increased considerably over the past 20 years. Because of this rise and the inherent complexity of ASD, there is a need for an increased number of scientifically valid basic and clinical research studies addressing this disorder. This manuscript serves as an introduction to the clinical presentation of ASD as well as the unique challenges and modifications required to conduct clinical research with this population. This includes detailing the current diagnostic criteria, process of receiving an ASD diagnosis, information on assessment measures, and special considerations when developing research. It is the hope that this information will provide researchers interested in conducting clinical trials with those with ASD with baseline information and considerations when developing their research topics and methodology.

Streamlining screening of emotional function in Veterans with traumatic brain injury.

OBJECTIVES: This study examined how depression, anxiety, and sleep items from the Neurobehavioral Symptom Inventory (NSI) predict results from longer inventories. METHOD: This was a retrospective review from 484, predominantly male (96.1%) Veterans, mean age 29.7 years, who underwent brief neuropsychological screening during a comprehensive, multidisciplinary evaluation for mild traumatic brain injury (TBI). Participants completed the NSI, insomnia severity index (ISI), and hospital anxiety and depression scale (HADS). RESULTS: OVERALL,: 97.1% who endorsed "severe"/"very severe" anxiety on the NSI had significant anxiety on the HADS; 85% reporting "severe"/"very severe" depression on the NSI, had significant depression on the HADS; and 97.7% reporting "severe"/"very severe" sleep problems on the NSI, had significant sleep difficulties on the ISI. CONCLUSION: Close correspondence between "severe"/"very severe" symptoms on the NSI and lengthier checklists suggests additional checklists may be eliminated and individuals can be referred for mental health treatment. NSI reports of "mild"/"moderate" require further screening.

Delirium Detection and Impact of Comorbid Health Conditions in a Post-Acute Rehabilitation Hospital Setting.

Misdiagnosis and under-detection of delirium may occur in many medical settings. This is important to address as delirium clearly increases risk of morbidity and mortality in such settings. This study assessed whether Veterans who screened positive on a delirium severity measure (Memorial Delirium Assessment Scale; MDAS) differed from those with and without corresponding medical documentation of delirium in terms of cognitive functioning, psychiatric/medical history, and medication use. A medical record review of 266 inpatients at a VA post-acute rehabilitation unit found that 10.9% were identified as delirious according to the MDAS and/or medical records. Of the Veterans who screened positive on the MDAS (N = 19), 68.4% went undetected by medical screening. Undetected cases had a higher number of comorbid medical conditions as measured by the Age-Adjusted Charlson Index (AACI) scores (median = 9, SD = 3.15; U = 5.5, p = .003) than medically documented cases. For Veterans with a score of 7 or greater on the AACI, the general relative risk for delirium was 4.46. Delirium is frequently under-detected in a post-acute rehabilitation unit, particularly for Veterans with high comorbid illness. The relative risk of delirium is up to 4.46 for those with high medical burden, suggesting the need for more comprehensive delirium screening in these patients.

Reliability and factor structure of the Hospital Anxiety and Depression Scale in a polytrauma clinic.

The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure of anxiety and depression symptoms. This study examined the internal consistency and factor structure of the HADS among Veterans in a polytrauma/traumatic brain injury clinic. The sample consisted of 312 Veterans. A confirmatory factor analysis of the depression and anxiety subscales showed, not surprisingly, that the two factors were highly correlated (r = 0.7). Goodness of fit statistics for the two-factor model were acceptable (root mean square error of approximation = 0.06, comparative fit index = 0.94). The HADS demonstrated very good reliability overall (alpha = 0.89) and for the individual subscales (alpha = 0.84). This study supports the use of the HADS as a screen for depression and anxiety in the assessment of mild traumatic brain injury in a Veteran population.

Limited usefulness of the Rey Fifteen-Item Test in detection of invalid performance in veterans suspected of mild traumatic brain injury.

OBJECTIVE: This study explored using the FIT as a measure of performance validity among veterans undergoing neuropsychological evaluation for mild traumatic brain injury (mTBI). BACKGROUND: The Rey Fifteen-Item Memory Test (FIT) is a performance validity measure criticized for poor sensitivity. METHODS: Two hundred and fifty-seven veterans completed the FIT and Wechsler Adult Intelligence Scale, Fourth Edition, Digit Span (DS); 109 of whom completed the Test of Memory Malingering (TOMM). FIT cut-offs of <9, <8 and stricter cut-offs were examined using DS and/or TOMM as criterion performance validity measures. RESULTS: Only four participants scored below the standard cut score of 9 on the FIT. Among the 13 veterans failing both criterion tests, only two scored below 9 on the FIT. Regardless of which FIT cut-off was used, the FIT had poor diagnostic accuracy. CONCLUSION: Despite its popularity, the FIT is not supported as an appropriate measure of performance validity in veterans undergoing evaluation for possible mTBI. Therefore, inferences regarding neuropsychological data reliability with adequate statistical certainty require use of other measures of performance validity with greater sensitivity.