Here's How to Include Patients With PD in Study Design, Execution, Researchers Say

Although patient-centered research is growing, there are no established standards or best practices geared specifically to address the complex nature of individuals living with Parkinson disease (PD) who may want to participate.

A paper published last month, whose coauthors included 2 patients with Parkinson disease (PD), presented a set of standards for researchers to consider when considering the inclusion of patients in study design and execution.

Research that includes patients in a meaningful way from conception to completion shows several benefits, including outcomes that matter to patients, as well as fewer dropouts, faster recruitment, and speedier completion, all of which lower costs. Although patient-centered research is growing, there are “specific challenges that come with Parkinson’s disease,” noted the authors, writing in the Journal of Parkinson’s Disease.

"Involving people with the lived experience of the health condition under study is a prerequisite for any research project," the authors stated.

With the intent of providing guidance on this topic, the authors proposed key points to keep in mind when engaging individuals with PD to get involved with research:

  • Mobility issues may create barriers for some individuals if travel to meetings is required, but online conference calls are one solution.
  • Executive function deficits and cognitive impairment may be present; handouts and other aids might be helpful.
  • Patients may experience off phases when their medications stop working until it is time for their next dose, so scheduling meetings and calls around these times would help encourage participation.
  • Nonmotor symptoms like pain, apathy, fatigue, and depression may be present but may not be an obstacle to participating and may even motivate patients to participate.
  • Some patients have very quiet voices and may need the chance to repeat themselves, or they should be paired with a research expert when speaking in public.

Another point raised by the authors is the “tremendous inter-individual variability across different individuals living with [PD], so inclusion of just a limited number of patient researchers will inevitably only offer a restricted perspective of the overall needs of the worldwide [PD] population.”

The paper also noted that the cost of reimbursing patients, not only for their expenses, but also for their time, should be included in any funding requests.

The paper was coauthored by 2 researchers from Radboud University Medical Center, Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands—lead author Marjan J. Meinders, PhD, and Bastiaan R. Bloem, MD, PhD—as well as 2 patient representatives from the Patient Council of The Michael J. Fox Foundation for Parkinson’s Research, Anne C. Donnelly, DPH, and Margaret Sheehan, JD.

Reference

Meinders MJ, Donnelly AC, Sheehan M, Bloem BR. Including people with Parkinson’s disease in clinical study design and execution: a call to action. J Parkinsons Dis. Published online April 4, 2022. doi:10.3233/JPD-223190