A neurocognitive assessment is an evaluation conducted to determine an individual’s level of thinking skills, including memory, attention, reasoning, visual-perceptual skills and the ability to manage everyday activities.
Standardized neurocognitive assessment is often conducted within the framework of clinical drug trials research to understand the potential impact of new treatments on cognitive functioning. Typically, a highly trained and certified professional administers the selected neurocognitive assessment, which consists of a battery of reliable and validated paper and pencil and/or computerized tests.
Increasingly, neurocognition is assessed in clinical drug trials. As patients live longer, their ability to make treatment decisions, interact with care givers, and follow treatment guidelines is impacted by their neurocognitive competence. Importantly, across several psychiatric and neurologic disorders, better cognitive functioning is associated with and predicts better functional outcome. Numerous studies have shown that neurocognition is significantly correlated with overall quality of life (Newman et al, 2001; Farace & Shaffrey , 2001; Reid-Arndt, et al 2010; Shamsi et al 2011; etc). Mitchell et al (2010) found that cognitive impairment influences return to work, interpersonal relationships and leisure activities.
Neurocognitive assessment has been shown to predict more than quality of life however. Adding neurocognitive performance predicts survival better than clinical prognostic factors alone in patients with primary brain tumors (Meyers et al., 2000), leptomeningeal disease (Sherman et al., 2002), and brain metastases (Taphoorn & Klein, 2004). In fact, some studies (eg., Meyers & Hess, 2003) have found that neurocognitive assessment was more sensitive than MRIs in demonstrating evidence of cancer progression. Recently, neurocognitive testing has established that cognitive dysfunction occurs prior to chemotherapy and/or radiotherapy in some patients with non-CNS cancers such as prostate and breast cancer (Wefel et al., 2004; Meyers et al., 1995; Wefel, et al., 2010).
NeuroCog Trials can provide rater training and data review for all published neurocognitive tests.
Yes. We have a database of sites with which we have worked extensively and can provide information on these sites based upon the sponsor company’s needs.
Our process for training and certifying raters is comprehensive and continuous to ensure maximum completion rate and reliable data. The process is as follows:
- The prospective rater is screened using our Rater Evaluation Form.
- If deemed acceptable, access to our password-protected online training videos is provided.
- The prospective rater is required to:
- view the online training video
- review test-specific materials
- administer a test at least once to a colleague
- The prospective rater is then required to attend the Investigator Meeting, during which he/she:
- attends NeuroCog Trials’ training presentation (including Q & A session)
- administers the full testing battery to a NeuroCog Trials trainer during a 2-hour individual session
- If deemed proficient, the prospective rater is certified. Less prepared raters undergo a follow-up with NeuroCog Trials staff via phone or videoconference. Deficient raters are not certified.
All raters are monitored by NeuroCog staff throughout the trial and provided feedback regarding administration and scoring for every test. All certified raters who do not test for four consecutive months and all raters who produce more than one battery with uncommon errors are required to complete a refresher certification. Any rater who continues to make errors invalidating data is replaced.
NeuroCog Trials can provide either of these services depending on the sponsor company’s needs. In studies in which cognition is a primary outcome measure, we highly recommend data quality control whereby every neurocognitive test is reviewed by our staff for accurate administration and scoring. To complete the process of data quality control, NeuroCog Trials can also be responsible for ensuring accurate entry onto the Clinical Record Form or into the Electronic Data Capture. In studies where cognition is not the primary outcome measure, sponsor companies may be more comfortable with NeuroCog Trials conducting data quality assurance whereby neurocognitive tests are randomly requested from raters to ensure the administration and scoring procedures are being followed.
To minimize repetitive administration errors and maximize feedback benefits, raters are required to send all tests to NeuroCog Trials within two business days of administration.
All data points are reviewed twice – by two different NeuroCog Trials Data Monitors –and feedback regarding administration and scoring is provided within two business days.
Any missing test components are requested via email immediately upon receipt.
The first Data Monitor reviews testing materials to verify every data point. The second Data Monitor then reviews and re-verifies every data point. Queries are sent to the rater regarding patient performance and demeanor for all outlying scores.
Feedback regarding administration and scoring is compiled in a Word document template, password-protected and emailed to the rater. NeuroCog’s senior management team decides all unresolved discrepancies in Data Monitor’s scores. Dr. Keefe continuously reviews all study data to monitor for extreme scores and intra-patient inconsistencies.
Final scores are double entered in the NeuroCog database and a PDF file of the report is generated, password-protected and emailed to the study coordinator.
NeuroCog Trials often provides consultation to study statisticians to ensure cognitive data are best utilized. Additionally, we can assist in interpretation of statistical findings of cognitive data.
Yes. We offer unparalleled experience in evaluating sites for neurocognitive assessment in the United States, Canada, Eastern and Western Europe, Russia, Japan, and India. We have provided rater training and data quality assurance using translated versions of MCCB, the BACS, UPSA-B and SCoRs in a range of countries throughout Europe and Asia. And we have more than 14 local language experts.