Participating Virtually Appears Workable for Parkinson’s Research
People with Parkinson’s disease made accurate self-reported diagnoses and expressed interest in virtually participating in research studies, according to a recent analysis from the ongoing Fox Insight study.
That analysis was published in the journal Clinical Parkinsonism & Related Disorders, as a study called “Video-based Parkinson’s disease assessments in a nationwide cohort of Fox Insight participants.”
Clinical research requires patient participation but recruitment is often limited to individuals living nearest to a trial site. The global COVID-19 pandemic complicates things further by raising the health risks of in-person visits.
Online visits can overcome both of these challenges in some cases, allowing patients the option of participating virtually in research from the comfort of their own homes.
The Fox Insight study, launched by the Michael J. Fox Foundation, had explored the feasibility of virtual participation. It did so by having its participants complete a series of questionnaires covering quality of life, non-motor symptoms, physical activity, and general health.
The goal was to collect large amounts of self-reported data about the health experiences of adults with and without Parkinson’s. Healthy people are serving as a control group.
Now, researchers looked at a subset of participants from the Fox Insight study to validate individuals’ self-reported Parkinson’s diagnoses. This is essential in virtual participation, in which contact with a physician is limited.
The analysis also sought to validate other self-reported health information and to assess participants’ willingness to take part in future video-based studies.
A total of 203 participants from 40 U.S. states completed this study. A little over half (59%) were male and the group’s mean age was 65.7. A Parkinson’s diagnosis was confirmed remotely by a physician in 159 individuals, while that of 44 participants was not. Of those 44, eight had self-reported a Parkinson’s diagnosis.
Self-reported duration of Parkinson’s, age, sex, race, ethnicity, and the presence of resting tremors did not appear to associate with the level of agreement between self- and clinician-determined diagnoses.
Agreement varied somewhat, depending on the criteria used, with greater agreement (86%) between self-reported diagnoses and the NIH Parkinson’s Criteria, wherein participants reported having their condition for over 10 years, compared with 0 – 2 years (67%). Such agreement was not found for the U.K. Parkinson’s Criteria or the Movement Disorder Society Parkinson’s Criteria.
Nearly all participants (97%) expressed satisfaction with the study and 98.5% said they were willing to participate in future observational studies via virtual visits. Observational studies are those in which researchers merely observe for certain effects, rather than intervening with a participant in some way, such as with medications or other procedures.
A fewer number of individuals (76.1%) said that they would be willing to participate in an interventional trial involving some virtual visits. Finally, 68.5% replied that they would participate in either observational or interventional studies involving only virtual visits.
“Our study supports the validity of self-reported diagnosis in a large observational study, which is crucial to the interpretation of the validity of FI [Fox Insight] results,” the researchers concluded.
“Moreover,” they added, “our study demonstrates the promise of a much-needed novel model for conducting [Parkinson’s] research and highlights the potential of such a model for re-starting and advancing clinical research in [Parkinson’s] in the midst of a pandemic.”