Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials.

Background and Objectives: Representation of persons from marginalized racial and ethnic groups in Parkinson disease (PD) trials has been low, limiting the generalizability of therapeutic options for individuals with PD. Two large phase 3 randomized clinical trials sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), STEADY-PD III and SURE-PD3, screened participants from overlapping Parkinson Study Group clinical sites under similar eligibility criteria but differed in participation by underrepresented minorities. The goal of this research is to compare recruitment strategies of PD participants belonging to marginalized racial and ethnic groups. Methods: A total of 998 participants with identified race and ethnicity consented to STEADY-PD III and SURE-PD3 from 86 clinical sites. Demographics, clinical trial characteristics, and recruitment strategies were compared. NINDS imposed a minority recruitment mandate on STEADY-PD III but not SURE-PD3. Results: Ten percent of participants who consented to STEADY-PD III self-identified as belonging to marginalized racial and ethnic groups compared to 6.5% in SURE-PD3 (difference = 3.9%, 95% confidence interval [CI] 0.4%-7.5%, p value = 0.034). This difference persisted after screening (10.1% of patients in STEADY-PD III vs 5.4% in SURE-PD 3, difference = 4.7%, 95% CI 0.6%-8.8%, p value = 0.038). Discussion: Although both trials targeted similar participants, STEADY-PD III was able to consent and recruit a higher percentage of patients from racial and ethnic marginalized groups. Possible reasons include differential incentives for achieving minority recruitment goals. Trial Registration Information: This study used data from The Safety, Tolerability, and Efficacy Assessment of Isradipine for Parkinson Disease (STEADY-PD III; NCT02168842) and the Study of Urate Elevation in Parkinson's Disease (SURE-PD3; NCT02642393).

Clinical and Economic Outcomes Associated with Dysphagia in Hospitalized Patients with Parkinson's Disease.

BACKGROUND: Dysphagia is a frequent complication that may increase morbidity and mortality in Parkinson's disease (PD). Nevertheless, there is limited data on its objective impact on healthcare outcomes. OBJECTIVE: To investigate the outcomes associated with dysphagia in hospitalized patients with PD and associated healthcare costs and utilization. METHODS: We performed a retrospective cohort study using the National Inpatient Sample (NIS) data from 2004 to 2014. A multivariable regression analysis was adjusted for demographic, and comorbidity variables to examine the association between dysphagia and associated outcomes. Logistic and negative binomial regressions were used to estimate odds or incidence rate ratios for binary and continuous outcomes, respectively. RESULTS: We identified 334,395 non-elective hospitalizations of individuals with PD, being 21,288 (6.36%) associated with dysphagia. Patients with dysphagia had significantly higher odds of negative outcomes, including aspiration pneumonia (AOR 7.55, 95%CI 7.29-7.82), sepsis (AOR 1.91, 95%CI 1.82-2.01), and mechanical ventilation (AOR 2.00, 95%CI 1.86-2.15). For hospitalizations with a dysphagia code, the length of stay was 44%(95%CI 1.43-1.45) longer and inpatient costs 46%higher (95%CI 1.44-1.47) compared to those without dysphagia. Mortality was also substantially increased in individuals with PD and dysphagia (AOR 1.37, 95%CI 1.29-1.46). CONCLUSION: In hospitalized patients with PD, dysphagia was a strong predictor of adverse clinical outcomes, and associated with substantially prolonged length of stay, higher mortality, and care costs. These results highlight the need for interventions focused on early recognition and prevention of dysphagia to avoid complications and lower costs in PD patients.

Trends of inpatient palliative care use among hospitalized patients with Parkinson's disease.

INTRODUCTION: Palliative care in Parkinson's Disease (PD) is an effective intervention to improve quality of life, although historically, access and availability have been very restricted. METHODS: We performed a retrospective cohort study using the National Inpatient Sample (NIS) data from 2007 to 2014. Diagnostic codes were used to identify patients with PD and palliative care referral. Trends were calculated and logistic analysis performed to identify predictors of palliative care use. RESULTS: We identified 397,963 hospitalizations from 2007 to 2014 for patients with PD. Of these, 10,639 (2.67%) were referred to palliative care. The rate of consultation increased from 0.85% in 2007 to 4.49% in 2014. For 1 unit in year increase, there was 1.23 time the odds of receiving palliative consultation (OR 1.23, CI 1.21-1.25, p < 0.0001). Hispanics (OR 0.90, CI 0.81-1.01, p = 0.0550), Black (OR 0.90, CI 0.81-1.01, p = 0.0747) and White patients had similar rates of referral after adjustment. Women were less likely to be referred to palliative care (OR 0.90, CI 0.87-0.94, p < 0.0001). Other factors strongly associated with a higher rate of referrals included private insurance when compared to Medicare (OR 2.14, CI 1.89-2.41, p < 0.0001) and higher income (OR 1.41, CI 1.30-1.53, p < 0.0001). CONCLUSION: There has been a significant increase in palliative care referrals among hospitalized patients with PD in the US, although the overall rate remains low. After controlling for confounders, racial and ethnic disparities were not found. Women, patients with Medicare/Medicaid, and those with lower income were less likely to be referred to palliative care.