OBJECTIVES

Parkinson’s disease remains a chronic condition with major unmet needs. Understanding the nature and extent of patient experiences is hampered by a lack of clarity about whether well-developed patient-reported outcomes (PROs) exist or which PRO instrument fits better for Parkinson’s disease. To better inform the selection of PROs that could potentially be used in future clinical trials, the objective was to identify and summarize PRO instruments that have been validated and/or used in the published literature of Parkinson's disease through a systematic literature review.

METHODS

A systematic search of computerized databases PubMed and PsycINFO was conducted between January 2000 and December 2019. Articles were included in the review based on predefined criteria;1)Adults with Parkinson's disease, 2)"Patient-reported" outcome and experience measures;3)Published in English language;4)Sample size >50. The literature screening was conducted by 2 independent reviewers. All of the included studies were assessed for quality.

RESULTS

The search yielded a total of 215 articles from 2000 to 2019. The majority of studies are randomized control trials. Overall, we found 16 PROs in the published literature. The patient-reported outcome tool for advanced Parkinson's disease (PRO-APD) evaluates the perceptions of symptom severity and therapy expectations were rated on a Likert scale with score -3 to +3 (very worse to very much improved). Parkinson's disease symptom and severity were evaluated using 39-item Parkinson's Disease Questionnaire (PDQ-39), Freezing of Gait Questionnaire,MDT-PD(Munich Dysphagia Test-Parkinson's Disease), Unified Parkinson Disease Rating Scale. Some studies rated symptom severity on a Likert scale scoring from 0 to 7. The PROs were administered by clinician or patients. We also observed substantial variations in measuring disease symptoms and severity.

CONCLUSIONS

As FDA’s 21st-century cure act recommends collecting patient experience data during the drug development process, this review systematically summarized patient-reported outcome measures that could be used in future clinical trials and help in understanding patient experience.