Video-Based Assessment of Parkinson Disease May Be Path Forward for Clinical Trial Recruitment

Study data published in Clinical Parkinsonism & Related Disorders support the validity and accuracy of a self-reported Parkinson disease (PD) diagnosis. In a clinical cohort of US adults, self-reported PD diagnosis had high agreement with clinician-determined diagnosis. The widespread adoption of self-report diagnosis may alleviate the burden of clinical trial recruitment, which is frequently hampered by complex, in-person diagnostic assessments.

The Fox Insight cohort is an ongoing online prospective clinical trial that has enrolled more than 45,000 adults with and without PD. The study seeks to enable study participation without requiring in-person assessments.

Recruitment for PD research trials can be challenging due to the use of extensive in-person assessments to confirm the clinical diagnosis. Trial recruitment has been further inhibited by the COVID-19 pandemic, which has led providers to limit in-person clinic attendance.

As such, the present study sought to assess the feasibility of a self-reported PD diagnosis in a clinical research setting. A randomly selected subgroup of Fox Insight enrollees was invited to complete a series of questionnaires capturing demographic information, PD symptoms, and diagnosis history.

Participants then completed a virtual visit meant to clinically assess PD symptoms. Virtual visits were conducted by investigators who were blinded to self-reported PD status.

Cohen’s kappa coefficient was used to determine the level of agreement between self-reported diagnosis and clinician-determined diagnosis. Patients were also surveyed to determine 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 assessment visit between September 2018 and April 2019. Their mean age was 65.7±9.8 years; 59% of participants were men, and 96% were White. Overall, 38 (18.7%) participants self-reported no PD; the remaining participants self-reported a diagnosis of PD 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%).

Agreement between self-reported and clinician-determined PD diagnosis was very good, with a kappa value of 0.85 (95% CI, 0.76-0.94). Disagreement between patients and clinicians occurred in 10 cases (4.9%). In 4 of these cases, the self-reported diagnosis in the overall Fox Insight cohort differed from the diagnosis presented to clinicians in the present study. No substantial differences in agreement were observed according to PD duration, age, sex, race/ethnicity, or presence of resting tremor on clinical examination.

When surveyed, 97.9% of patients reported feeling satisfied or very satisfied with the current study. More than 90% of patients reported feeling that the virtual assessments were accurate. Nearly all (98.5%) participants indicated that they were willing to participate in future studies. A small proportion (12.1%) indicated that they would prefer in-person study visits.

These results establish the validity of self-reported PD status and remote clinician evaluation for PD. Nearly all patients with self-reported PD also received a clinical diagnosis following virtual assessment. However, the present analysis recruited fewer than 10% of current Fox Insight participants. A broader study of a greater number of patients is needed to confirm these findings.

“[O]ur study supports the validity of self-reported diagnosis in a large observational study, which is crucial to the interpretation of the validity of [Fox Insight] results,” investigators wrote. “Moreover, our study demonstrates the promise of a much-needed novel model for conducting PD research and highlights the potential of such a model for re-starting and advancing clinical research in PD in the midst of a pandemic.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

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