VeraSci Demonstrates Sensitivity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Subjective Cognitive Decline

Clinical trials in mild to moderate Alzheimer’s Disease (AD) rely on informant reports to characterize study participants’ performance on basic and instrumental activities of daily living.  As clinical trials move earlier in the AD continuum, however, these informant-based methods become very problematic. Unlike participants with mild-moderate disease, participants in primary and secondary AD prevention trials are generally healthy, often cognitively normal and largely independent. Thus, these informant-based assessment methods lack sensitivity to the subtle declines in instrumental activities of daily living in this patient population. Also, the inclusion of an informant in study designs is unnecessary, burdensome and may compromise enrollment.

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a direct performance-based assessment of IADL functioning that uses a computer or tablet interface and is appropriate for multiple populations. Unlike informant-based measures, the VRFCAT is completed by the study participant directly; an informant is not required.

In order to evaluate the sensitivity of the VRFCAT to the earliest declines in self-reported cognitive function, our team at VeraSci partnered with academic colleagues to recruit and evaluate 245 healthy young adults (age 20-54) and 308 healthy older adults (age 55-97). Older adults were screened for subjective cognitive decline using the Cognitive Functional Instrument (CFI, also referred to as the ADCS Mail-In Cognitive Function Screening Instrument (MCFSI). The questionnaire was designed to assess recent changes in cognition and functional activities that are commonly affected in the development of MCI. Furthermore, increased CFI scores have been associated with amyloid burden in healthy older adults, suggesting that this self-reported measurement serves as a useful screening instrument for preclinical AD. Of the 308 older adults assessed, 61 met the criteria for Subjective Cognitive Decline based on CFI scores greater than or equal to 4.

Our results demonstrated that the VRFCAT is sensitive to the deficits of in older adults with subjective cognitive decline, as they performed significantly worse than age-matched normative controls on all VRFCAT endpoints. Both groups performed significantly worse than healthy younger adults (age 20-54). Participants with subjective cognitive decline also performed significantly worse than controls on cognition as measured by the Montreal Cognitive Assessment (MoCA) and Brief Assessment of Cognition (BAC) verbal memory. All VRFCAT summary measures had correlations greater than r=0.5 with MoCA performance and assessments of Verbal Memory (p<0.01 for all), suggesting consistency between VRFCAT performance and key cognitive indicators of decline in MCI and AD.

 

Full results are reported in the current issue of the Journal of Prevention of Alzheimer’s Disease.

A.S. Atkins, A. Khan, D. Ulshen, A. Vaughan, D. Balentin, H. Dickerson, L.E. Liharska, B. Plassman, K. Welsh-Bohmer, R. S.E. Keefe; J Prev Alz Dis 2018;5(4):216-224

http://www.jpreventionalzheimer.com/current-issue.html

Holiday Language Blog Series – Part Three, Cultural Adaptation

Welcome to the third and final installment of our three-part blog series highlighting the importance of choosing the right language services partner.

Cultural Adaptation and Localization

Cultural adaptation and localization of clinical trial translations can be pivotal components to the success of a clinical trial. Localization and cultural adaptation go beyond textual translation and modify content for regional and/or local consumption. Localization modifies content and elements of a trial to appeal to patient’s cultural preferences in their own local language.

Cultural adaptation and localization services are just as important as translation services to accurately represent the implementation and outcomes of a clinical trial. Cultural adaptation can improve the quality of formally translated instruments by ensuring tasks, stimuli, instructions and, scoring are appropriate for populations of interest. Detailed attention to these issues is likely to enhance any real signal in a clinical trial, where the translated instrument serves as an endpoint.

The notion of Santa Claus is not a uniquely American tradition. In fact, many countries and cultures around the world celebrate the tradition of Santa Claus although symbolism, languages and, customs differ greatly.

 

 

Using VeraSci’s methods for cultural adaptation, errors can be identified and corrected prior to use in clinical trials, yielding gains in the reliability and validity of translated instruments and avoiding costly delays. Our linguistic experts bring not only translation skills and cultural awareness to each project, but clinical trials experience as well, ensuring that the information provided does what it should do: enable trial participant understanding.

Accurate translation, interpretation, and cultural adaptation are vital to a successful global clinical trial. By working together with sponsors, regulatory committees and other suppliers of research-related services, VeraSci can cut costs, help you to meet critical trial deadlines, and ensure successful international clinical trials.

5 Benefits of Using VeraSci for Global Language Services

  • Quality: KPI of 99% first-time accuracy for all translations done by humans. Our unique workflow includes quality assurance oversight by a team of PhD-level scientists as well as in-house software development and information technology teams, ensuring that the complexities of medical and technical terminologies are correctly translated.
  • Clinical Trial Expertise: Our linguists are often specialists in their field and are considered subject matter experts. They must pass a stringent nationally and internationally recognized certification process and are supported by a team of PhDs and clinical professionals to guarantee scientifically accurate translations at all times. VeraSci has extensive experience in executing large multi-year projects around the globe and is dedicated to ensuring the highest level of language services delivered at the pace to support global clinical trials.
  • Customer Satisfaction: At VeraSci, we go beyond the industry standard to provide a higher level of translation accuracy and agility by delivering customer-focused solutions and processes.
  • On-Time Delivery: Our 100% on-time delivery metric illustrates our commitment to meeting deadlines. Guaranteed quicker turnaround times due to in-house linguistic assets and centralized project management operations
  • Competitive Pricing: VeraSci’s long-term relationships with our expert team of linguists allows us to obtain lower cost, giving us the flexibility to meet client requirements and customize project approach to meet budget requirements.

 

Click here to read Holiday Language Blog Series – Part One, Translation

Click here to read Holiday Language Blog Series – Part Two, Interpretation

Holiday Language Blog Series – Part Two, Interpretation

Welcome to the second installment of our three-part blog series highlighting the importance of choosing the right language services partner.

 

Interpretation

Interpretation goes beyond the word-for-word translation of a spoken or written message. Sentence structure differs from language to language, and word-for-word translations often make very little sense to the target audience.

Interpretation is all about paraphrasing. Interpreters need to transpose the source language within context while preserving its original meaning. Rephrasing jargon and culturally-specific expressions in ways the target audience can understand is part language skill and part cultural awareness.

Interpreters deliver their messages on the spot with no help from scripts, dictionaries, or other reference materials. They rely solely on their experience, memory, and agile reflexes. Poor and inaccurate interpretations can damage the validity of data and create roadblocks to meeting critical deadlines.

In addition to the stringent nationally and internationally recognized certification process required of all VeraSci interpreters, many of them are specialists in their field and considered subject matter experts. A considerable number have direct clinical trials experience, bringing context that elevates accuracy and understanding.

In settings like an Investigator Meeting for a global clinical trial, it is absolutely crucial that all sites receive consistent information to ensure that the data collection process does not deviate from the standard. Because of their clinical trials experience, VeraSci interpreters understand the nuances required in interpreting instructions so that site personnel perform trial-related tasks consistently and data quality is protected.

In addition to interpretation services, VeraSci specializes in translation, localization, and training in over 150 languages. Check back next week to learn how localization and cultural adaptation can help to enhance any real signal in a clinical trial.

Click here to read Holiday Language Blog Series – Part One, Translation

Holiday Language Blog Series – Part One, Translations

In the sharing spirit of the season, VeraSci is presenting a three-part blog series to use as a guide when selecting your language services partner. With the enormous investments and challenging timelines required for bringing new therapies to market, choosing the right partner has never been a more critical decision.

In this, our first post of the series, we’ll cover translation services and some of the advantages of working with a language partner experienced in clinical trials. In the second installment, we’ll explain why accurate interpretation is critical to the success of a clinical trial and how having the right partner can make all the difference. We’ll finish up the series by illustrating the impact that localization and cultural adaptation can have when executing trials across the globe.

For over a decade, VeraSci’s linguistics experts have been providing language services for global clinical trials. We hope the insight we’ve gained and will share in this blog series will prove valuable to you as you select your language partners in the future.

 

Translations

Accurate translations can make or break your study. The cost of translation is a fraction of a clinical trial, but the costs of incorrect translations are high and the risks to patients are real. One error in a translation can cause costly delays, endanger patients, and/or compromise data quality. On the other hand, accurate translations can improve trial participant understanding, which is key to a successful trial.

There are several options to choose from for clinical trial document translation, two of which are:

  • Using Machine Translation (MT) – software such as Google Translate
  • Enlisting professional translation services experienced in clinical trials

Which option you choose will largely depend on your translation goals.

Machine translation is a good option if you are looking for a broad overview of a document or the general gist of what the document is about. It’s important to keep in mind, though, that many words and phrases have more than one meaning, as illustrated in our seasonal example of “Winter Wonderland.” Machines often struggle with idioms and other non-literal translations, whereas professional language partners search for and identify non-literal translations and translate accordingly.

Choosing the right partner can increase the accuracy of your translations and help you to meet critical deadlines.

At VeraSci, we go beyond the industry standard to provide a higher level of translation accuracy and agility by delivering customer-focused solutions and processes. Our unique workflow includes quality assurance oversight by a team of PhD-level scientists as well as in-house software development and information technology teams, ensuring that the complexities of medical and technical terminologies are correctly translated. This workflow also has been developed for efficiency and has resulted in our 100% on-time delivery metric.

In addition to translation services, VeraSci specializes in interpretation, localization, and training in over 150 languages. Check back next week to find out how accurate interpretation can help you avoid costly pitfalls in your next clinical trial.

CNS Summit Post Conference Wrap Up

VeraSci attended CNS Summit in Boca Raton, Florida, November 1-4, 2018. CNS Summit is a platform for change in a community passionate about shaping the future through collaboration, innovation, and technology.

This year’s conference proved to be a dynamic environment for networking, sharing ideas, and exploring the future of drug development. The event included stimulating keynote sessions, engaging panel discussions, educational breakouts, and facilitated motivational collaboration with like-minded individuals.

VeraSci engaged with several innovative companies to explore novel digital endpoints, and sponsors and CRO partners were able to interact with the latest VeraSci Pathway® assessments at our newly rebranded booth.

Luca Pani, VeraSci’s VP of Regulatory Strategy and Market Access Innovation, interviewed FDA Associate Director of Digital Health Bakul Patel as well as participated in a rousing panel discussion regarding commercializing innovation.

VeraSci also presented their latest findings using the Pathway BAC. Their presentation “Predictive value and test-retest reliability of the tablet-based Brief Assessment of Cognition (BAC App) for assessment of cognition in aging” detailed results from our brief tablet-based assessment of the paper-and-pencil based Brief Assessment of Cognition (BAC) assessing multiple cognitive domains, including verbal memory, working memory, motor function, verbal fluency, processing speed and executive function. Our presentation demonstrated the validity of the BAC in older individuals with subjective cognitive decline, showing the diagnostic sensitivity, specificity and test-retest reliability of the BAC, and paving the way for the use of the BAC as a screening tool for studies of cognitive aging and Mild Cognitive Impairment.

Poster: Predictive value and test-retest reliability of the tablet-based Brief Assessment of Cognition (BAC App) for assessment of cognition in aging

4 Reasons to Visit VeraSci at CNS Summit