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  • Writer's pictureN-of-1 Hub

Person-centred single-case designs: A tool for evaluating individual digital health data

Updated: Feb 2, 2023

Person-centric healthcare emphasises the importance of a person’s active role in decisions about their health and treatment using their own personal health data. With the rise of digital technologies such as mobile apps and wearables, healthcare consumers have more opportunities to track and manage their own health than ever before. The wearable technology industry in particular is ‘making a mark’ in digital health, with the global wearable market valued at over $61 billion US in 2022. However, many digital health technologies generate a vast amount of data and making scientific sense of it can be challenging.

Evaluating digital health data

One way to approach the evaluation of individual digital health data is through conducting a personalised clinical study. A personalised clinical study uses a research method called a ‘single-case design’ where the focus is on evaluating an individual person over time through repeated and systematic measurements of specific health-related outcomes. In the healthcare context, single-case designs can be used to identify how an individual responds to a treatment or intervention (e.g. drugs, physical therapy, medical devices), as well as to track fluctuations and identify predictors of health-related outcomes such as physical activity and sleep over time. Recent advances in real-time monitoring technology, such as digital ecological momentary assessment, passive smartphone-based behavioural tracking, and physiological assessment with wearable biosensors, are well-suited to conducting the repeated, systematic outcome measurements which are required in a single-case design. StudyU is an example of an open source app that allows clinicians and researchers worldwide to easily design and conduct person-centred digital single-case studies with patients using a smartphone app on their mobile phone.

Person-centred digital single-case designs

Designing a single-case study is different from designing a standard clinical trial. In a single-case study, investigators need to consider factors such as using measures that are valid with frequent administration, the number and length of treatment periods, and balancing the minimum number of treatment periods with total length of study to maximize patient adherence to the study. A major benefit associated with conducting a single-case design is that they are flexible methods and allow the persons’ preferences, values and needs to be incorporated into the study design. For example, the patient can work with their clinician to choose outcome measures, the frequency of measurement, the length of study and many other parameters to co-create the design of the single-case study. This features makes single-case designs highly relevant in the era of person-centred healthcare.

N-of-1 Hub is a consulting company that specialises in designing, conducting and analysing personalised clinical studies using single-case designs. N-of-1 Hub also offers data management and analysis services and customised training workshops.

For more information about N-of-1 Hub, and to discuss your study needs, please contact us

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