Human-centered design:
Philips IntelliSpace Cognition
Digital technologies for cognitive assessment are far from new, but they may also be far from ideal, especially in terms of validation and ease of use. As a medical device company, Philips has a long history of developing clinical offerings that are steeped in clinical insights. We research, validate, and utilize clinical studies so we can offer patients, neurologists and neuropsychologists a tool that’s rapid, reliable and readily accessible – Philips IntelliSpace Cognition. According to neurologists, the two most important factors they consider when choosing a digital cognition assessment tool are whether the tool is well validated and whether it is easy to use. Specifically, survey results showed that these factors were ranked as “very important” by 73% and 72% of respondents, respectively.1
Answering a clinical need – validation
The cognitive assessment in IntelliSpace Cognition features well-established neuropsychological tests, each with its specific normative scores based on the same representative group of the US population. These normed outcome measures are validated against the traditional paper versions of each test. In 2019, Philips collected the normative data and test validation data through a study performed in accordance with the ISO14155 standard for good clinical practice.2 It involved collecting data across four different states from a group of 450 healthy participants enrolled using stratified sampling such that distributions of age (participants were between the ages of 50 and 80 years), sex, education level and racial/ethnic background reflect the US Census. For validation, we used data from this study to compare the psychometric properties of the digital IntelliSpace Cognition tests with their paper counterparts. Over Three-hundred participants in the study completed either the digital IntelliSpace Cognition tests or paper versions of the tests once or twice in repeated visits that were about two to three weeks apart. Two hundred of the participants visited twice to perform both the digital ISC tests and the paper versions. Data from this subgroup allowed us to directly compare the IntelliSpace Cognition tests and paper tests for the same individuals.
While developing IntelliSpace Cognition (ISC), Philips followed procedures to allow listing with the US Food and Drug Administration (FDA). We also invested a significant effort to validate the digital neuropsychological tests and associated algorithms as well as to collect accurate normative data – quantitative measures used to compare an individual’s performance to that of a relevant population. A comparison to a normative baseline is essential to interpret an individual test score. It ideally also accounts for differences related to age, education and sex. Additionally, it is important to note that not comparing to normative data will often result in missing subtle signs of cognitive impairment.
After seeing a video of how IntelliSpace Cognition works, 80% of neurologists said they would feel confident using the tool because Philips has collected normative data to provide healthy peer comparisons.3
Answering a clinical need – ease of use
As mentioned above, validation solves only part of the clinicians’ need. If a digital cognitive assessment tool is not easy to administer or take, its value is nominal. To make IntelliSpace Cognition intuitive and easy to use, we followed a human-centered design that enables us to connect frequently and deeply with our users. We started by meeting with neurologists and neuropsychologists to understand their context, who they are, how they will use the product and what they will use it for. Our journey followed a deliberate path with the steps highlighted below: Careful consideration went into each design element. For example, the interface was created to be self-explanatory, require minimal intervention and reduce variability among assessors, so we included audio, text and animated instructions and buttons. For clinicians, the design of the test results and cognitive profile is visualized for fast and easy interpretation. That way, neurologists can focus their time on interacting with patients and assessing the nature and scope of cognitive deficits rather than on the individual test scores. To measure the ease of use, we do periodic usability tests that are strictly following the FDA human factors and usability engineering processes guidelines.
The attention to detail that Philips used while developing IntelliSpace Cognition has garnered accolades and awards in 2020. These include:
We are honored by this recognition and even more so by the feedback we received from the users themselves.
All of the clinicians in a usability study agreed that IntelliSpace Cognition was easy to use and required minimal learning.1 In another study of participants taking the test, respondents agreed that they found it easy to use.2 One 70-year-old participant stated, “I expected inconvenience...It’s simple enough.” Another user, aged 53, remarked, “Very easy to use and it looks nice...clear with no distractions or unnecessary things.”
Conclusion
Philips IntelliSpace Cognition is a digital cognitive assessment platform that is proven to serve clinicians and patients well by delivering in-depth cognitive insights easily and accurately. Extensive validation studies demonstrate alignment with the psychometric parameters of paper testing, accurate integration of algorithms. And, it provides normative comparison to a healthy reference group. With Philips IntelliSpace Cognition clinicians have a clear, quantifiable set of data to enable clinicians to decide next steps with confidence. In fact, 75% of neurologists said that using IntelliSpace Cognition could increase their confidence in making correct referral decisions for neuropsychological assessment.3
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References
1. Based on a 2020 Philips study with 90 neurologists. 2. Psychometric Properties of IntelliSpace Cognition www.clinicaltrials.gov/ct2/show/NCT03801382?term=NCT03801382&draw=2&rank=1. 5. Based on a 2019 Philips study with seven participants
3. Based on a 2019 Philips study with 100 neurologists
4. Based on a 2020 Philips usability study with 13 neurologists
