What drives health research?
There are several drivers of health research but fundamentally, it’s about scientists seeking answers to health-related questions in areas in which they may have a particular specialization.
Research scientists typically have hypotheses about connections, patterns, causation of different biological processes and other factors which, when better understood, could lead to breakthroughs that impact peoples’ health and lives.
It is this combination of a need to improve peoples’ well-being and scientific curiosity that drives the creation of new clinical studies.
Defining clinical cohorts in research
When conducting health research, it is critical to be able to group people in categories – be it by sex, by age, or by any number of other demographic or clinical factors – in order to start to see patterns and relationships.
Demographic and various clinical factors are captured through physician observations or patient-reported questionnaires. Essentially, any data that are collected in a doctor’s office often prove to be important in understanding the trajectory of diseases: providing clues for why certain patterns are emerging, or helping lead researchers to new, illuminating questions.
In ONDRI’s studies, these data are collected through the Clinical Platform, forming a very important backbone of the research.
“The clinical platform is typically not designed to be the basis of research studies”, said Brian Tan, ONDRI’s Clinical Platform Lead and data scientist at Baycrest Health Sciences.
He continues:” It’s there to paint a holistic picture of each participant. It’s in the background, part of the search criteria, whenever a researcher looks at the data, whenever a paper is being written. These clinical data help researchers understand the patterns that they are seeing within their own research spheres.”
In other words, the clinical platform helps researchers connect the dots between what is observed or reported in the clinic and a patient’s underlying biology.
Clinical dimensions can help answer research questions
An example that comes to mind, where the clinical data were critical to illuminating patterns seen through a different lens, was ONDRI’s study that examined participants’ perivascular spaces (PVS, fluid filled gaps surrounding the brain’s blood vessels) and sleep patterns.
This study, led by Joel Ramirez PhD and Andrew Lim MD, was interested in whether participants who were showing enlarged PVS through their magnetic resonance imaging (MRI) workups tended to experience different sleep behaviours/patterns.
By isolating individuals with an enlarged PVS – indicating a blockage – and cross checking their sleep questionnaire (part of the clinical platform), researchers made an interesting observation: participants with enlarged PVS tended to self report sleeping longer than those with normal or small PVS.
The hypothesis to explain this pattern is that this sleeping behaviour was the body’s way of compensating for the dysfunction. Having the clinical data with which to validate these observations was key.
Note: Self-reported questions about sleep form part of the clinical platform questionnaires highlighted above.
ONDRI cohort clinical characteristics now published
Data from the clinical platform forms the basis for a journal article, recently published in Alzheimer’s & Dementia, the journal of the Alzheimer’s Association, entitled “Characteristics of the Ontario Neurodegenerative Disease Research Initiative cohort.”
This article describes the ‘baseline’ features of the groups studied in ONDRI’s foundational study and summarizes recruitment, data collection and curation processes. The article introduces researchers and other interested parties to details of these data, which must be understood for appropriate interpretation of subsequent baseline and longitudinal analyses.
The article and the clinical platform data therein also help researchers to understand ONDRI’s foundational study better, so that they can determine how to utilize the high-quality data appropriately.
The ONDRI foundational study cohort
The article referenced above shows how heterogenous the ONDRI foundational study cohort was – capturing a wide spectrum of clinical presentations plus mixed diseases. No two study participants were alike!
The heterogeneity of the ONDRI cohort reinforces what is already known in this area; i.e., that neurodegenerative diseases are highly complex, and that much more research needs to be carried out before cohorts that truly represent streamlined, distinct groups can be put together.
At the same time, it is interesting to note that a disproportionate part of the ONDRI population was:
- At the earlier stage in disease progression
Why was this population largely male?
ONDRI researchers believe that the answer to this question lies in the fact that a study partner was required for participation in the study. Participants with spousal study partners are more often male, white, and more educated. In addition, the geographic location of tertiary clinics from which different disease groups were recruited may have created some unexpected associations between demographics and disease.
Lastly, ONDRI’s foundational study was largely facilitated through doctors’ offices and put a significant burden on study participants.
Over the past several years, particularly due to restrictions from the COVID19 pandemic, many new assessments which can be administered over the phone or a video-call have come into wider use in research studies.
Such developments reduce the burden placed on participants – such as the need to arrange a visit to research sites – and can remove geographical barriers that prevent participation. ONDRI’s clinical platform has greatly benefited from these new methods, and they are being used in the HANDDS-ONT study.
Brian Tan, MSc.
Clinical Platform Lead