Neurological

Video-based assessment of Parkinson’s disease can be a way forward for clinical trial recruitment

Study data published in Clinical Parkinsonism & Related Disorders support the validity and accuracy of a self-reported Parkinson’s diagnosis. In a clinical cohort of US adults, the self-reported PD diagnosis was in high agreement with the diagnosis established by the clinician. The widespread adoption of self-report diagnostics can reduce the burden of clinical trial recruitment, which is often hampered by complex personal diagnostic assessments.

The Fox Insight Cohort is an ongoing prospective online clinical study that enrolled more than 45,000 adults with and without Parkinson’s disease. The study is designed to enable study participation without the need for personal assessments.

Recruiting for PD research studies can be challenging due to the use of extensive personal assessments to confirm clinical diagnosis. Study recruitment has been further hampered by the COVID-19 pandemic, which has led providers to limit personal attendance at clinics.

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Therefore, the present study attempted to evaluate the feasibility of self-reported PD diagnosis in a clinical research setting. A random subset of Fox Insight attendees was invited to complete a series of questionnaires that recorded demographic information, PD symptoms, and diagnostic history.

Participants then conducted a virtual visit that was used to clinically assess Parkinson’s symptoms. Virtual visits were made by investigators who were blind to self-reported PD status.

Cohen’s kappa coefficient was used to determine the degree of correspondence between the self-reported diagnosis and the doctor-determined diagnosis. Patients were also surveyed to determine their satisfaction with virtual visits and willingness to participate in future virtual PD studies.

A total of 203 adults from 40 US states completed a virtual clinical exam visit between September 2018 and April 2019. Their mean age was 65.7 ± 9.8 years; 59% of the participants were men and 96% were white. A total of 38 (18.7%) participants reported no PD themselves; the remaining participants themselves reported a PD diagnosis with a duration of up to 2 years (28.6%), 3 to 5 years (20.2%), 6 to 9 years (15.8%), or 10 years or longer (16.7%).

The agreement between the self-reported and the doctor-determined PD diagnosis was very good with a kappa value of 0.85 (95% CI 0.76-0.94). In 10 cases (4.9%) there were differences of opinion between patients and clinicians. In 4 of these cases, the self-reported diagnosis across the Fox Insight cohort was different from the diagnosis presented to clinicians in the present study. No significant differences in agreement for duration of PD, age, sex, race / ethnicity, or the presence of resting tremors were observed during clinical evaluation.

In the survey, 97.9% of the patients stated that they were satisfied or very satisfied with the current study. More than 90% of patients said the virtual ratings were correct. Almost all (98.5%) participants said they were willing to take part in future studies. A small proportion (12.1%) said they would prefer face-to-face study visits.

These results demonstrate the validity of self-reported PD status and remote clinical assessment for PD. Almost all patients with self-reported PD also received a clinical diagnosis after a virtual assessment. However, less than 10% of current Fox Insight attendees were recruited for this analysis. A larger study with a larger number of patients is needed to confirm these results.

“[O]Our study supports the validity of the self-reported diagnosis in a large observational study necessary for the interpretation of the validity of [Fox Insight] Results, ”wrote the investigators. “In addition, our study shows the promise of a much-needed novel model for conducting PD research and underscores the potential of such a model for restarting and advancing clinical research in PD amid a pandemic.”

Disclosure: Some study authors stated links with biotech, pharmaceutical, and / or device companies. For a full list of the author’s disclosures, see the original reference.

reference

Myers TL, Tarolli CG, Adams JL, et al. Video-Based Parkinson’s Disease Assessments in a Nationwide Cohort of Fox Insight Participants. Clin Park Relat Disord. 2021; 4: 100094. doi: 10.1016 / j.prdoa.2021.100094

This article originally appeared on Psychiatry Advisor

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