Schizophrenia has many different types of symptoms, including positive, negative, and cognitive symptoms. Positive symptoms are an addition of something, such as hearing or seeing things that aren’t there. Negative symptoms are a lack of something, for example, someone might appear emotionless or lose interest in daily life and activities. Cognitive symptoms are very heterogenous but can include impairment in working memory, attention and vigilance or social cognition.

Most treatments for schizophrenia focus on the positive symptoms, and there is a lack of effective interventions for the negative and cognitive symptoms. Clinical trials into treating negative symptoms or cognitive impairment in schizophrenia often focus on the patient’s functional status as an outcome. Examples of functional status include living independently and having the ability to work. These functional outcomes are important for a patient’s quality of life. They are also associated with a significant economic cost. Being able to rectify functional impairment will therefore have substantial benefits for schizophrenia patients, their families and wider society.

In this review, we analysed how function is measured in schizophrenia during clinical trials. We also explored recent developments in digital health and how these might be able to refine how function is measured during trials to improve patient experience, capture richer data and lower trial costs.

The potential for emerging digital technologies in schizophrenia trials

In clinical trials, measurements of function are usually provided through interviewer-rated questionnaires and scales, for example the Personal and Social Performance Scale (PSP) or self-reported measures of quality of life. Cognitive function is assessed through functional capacity measures such as the Schizophrenia Cognition Rating Scale (SCoRS). These methods can provide useful measures of overall function but can sometimes lack sensitivity within specific subdomains. They are also subject to bias, for example if the patient is unable to provide an accurate account of their everyday activities.  

Advances in digital capabilities over the last decade mean that it is now possible to collect a wide variety of passive and active information about patients’ daily functioning. Smartphones, smartwatches and other wearable devices are now able to capture ‘real-world’ functional data. Emerging technologies that are being used in schizophrenia trials include active, real-time digital measures such as short self-report assessments or tasks, administered at a high frequency. Data can also be collected passively, for example recording physical activity through a smartwatch. These technologies can capture data in the moment, meaning there is a lower chance that factors such as memory bias will have an effect. Data can also be collected over long time periods, creating detailed pictures of changes in function over time. These digital assessments can be used remotely, meaning effects of treatments can be observed in a real-world setting. Another key advantage is that use of these technologies will reduce the burden on patients taking part in trials and keep costs down.

While the use of digital technologies to measure functional outcomes in schizophrenia come with their own scientific, ethical, and practical challenges, they also hold great potential to help address the huge unmet need for effective treatments for negative symptoms and cognitive impairment in schizophrenia.

Get in touch

Cambridge Cognition develops validated digital health solutions including assessments of cognition via tablets, smartphones and smartwatches.  To find out more about our products and services, please get in touch.