- Email: [email protected]
Randomized, Placebo-Controlled, Phase III Study of Incobotulinumtoxina for Upper-Limb Post-Stroke Spasticity
e10 improvement. Subgroup analysis was completed on three TPO categories (i.e., acute, post-acute, chronic) in a repeated measures ANCOVA to determine the ability to make/maintain gains. Models controlled for age, admission Functional Independence Measure (FIM) score, and therapy intensity. Main Outcome Measure(s): FIM and Stroke Impact Scale (SIS). Results: In total, 1,416 individuals (53.5% male, mean age 70.013.2 years) accessed the CSRT program and received active therapy (4 visits). Regression analyses revealed no significant impact of TPO on any of the outcome variables. However, with each additional week post onset, the ability to make gains during CSRT service decreased in the FIM, SIS #1 (Physical Strength), #5 (ADLs) & #6 (Mobility). In subgroup analyses, all groups improved significantly on the FIM and SIS and maintained these gains at follow up. Conclusions: TPO was not shown to be a significant predictor of the ability of individuals to make gains within the CSRT program. This study supports that individuals would benefit from ongoing rehabilitation services throughout their stroke recovery process. Key Words: Stroke, Outpatient, Home-based rehabilitation Disclosures: None disclosed.
Oral Presentation 450 Safety and Efficacy of Increasing Doses of IncobotulinumtoxinA (400U-800U) for Upper and Lower Limb Spasticity: The Phase III TOWER Study John McGuire (Medical College of Wisconsin), Jo¨rg Wissel, Djamel Bensmail, Astrid Scheschonka, Olivier Simon, David M. Simpson Research Objectives: Patients with severe multifocal spasticity may benefit from botulinum toxin treatment at higher doses. This study evaluated the safety and efficacy of increasing incobotulinumtoxinA doses (400U-800U) for patients with spasticity. Design: Prospective, single-arm, dose-titration study (NCT01603459). Setting: Thirty sites in 8 countries (Norway, Germany, Spain, Italy, France, Portugal, Canada, and the United States). Participants: Adult patients (aged 18-80 years) with spastic hemiparesis due to cerebral causes. Interventions: Patients received 3 consecutive injection cycles (ICs) with 400U, 600U, and 600-800U incobotulinumtoxinA, respectively, each followed by 12-16 weeks of observation. Main Outcome Measure(s): Outcome measures included adverse events (AEs), Resistance to Passive Movement Scale (REPAS, based on the Ashworth Scale), Goal Attainment Scale, and EuroQoL 5-dimensions (EQ-5D) questionnaire. Results: In total, 155 patients were enrolled. IncobotulinumtoxinA dose escalation did not lead to an increased incidence of AEs (IC1:36.1%; IC2:37.5%; IC3:25.7%). The most frequent AEs were falls (7.7%), nasopharyngitis, arthralgia, and diarrhea (6.5% each). No treatment-related serious AEs occurred; 5 patients (3.2%) discontinued due to AEs. The mean (standard deviation [SD]) change in REPAS score from each injection to 4 weeks post-injection increased throughout the study (IC1:-4.6 [3.9]; IC2:-5.9[4.2]; IC3:-7.1[4.8]; P<0.0001 for all). The proportion of patients achieving 3 out of 4 treatment goals increased throughout the study (IC1: 25.2%; IC2: 50.7%; IC3: 68.6%). Mean (SD) EQ-5D QoL scores improved from 59.9 (18.9) at baseline to 69.7 (17.6) at the end of study visit (P<0.0001). Conclusions: Increasing incobotulinumtoxinA doses (400U up to 800U) enabled treatment in a greater number of muscles, leading to increased treatment efficacy resulting in improved muscle tone, individual goal attainment, and quality of life, without compromising patients’ safety or tolerability. Key Words: Muscle spasticity, Botulinum Toxin Type A, IncobotulinumtoxinA Disclosures: John McGuire, Jo¨rg Wissel, Djamel Bensmail, and David M. Simpson received support as investigators from Merz. Astrid Scheschonka and Olivier Simon are employees of Merz.
Oral Research Presentations Oral Presentation 459 Efficacy and Safety of Repeated Incobotulinumtoxina Injections for Upper-Limb Post-Stroke Spasticity Christina Marciniak (Rehabilitation Institute of Chicago), Atul T. Patel, Michael C. Munin, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic Research Objectives: To investigate efficacy and safety of repeated incobotulinumtoxinA injections for upper-limb post-stroke spasticity. Design: A 36-week open-label extension (OLEX) of the randomized, doubleblind, placebo-controlled main period of a phase III trial (NCT01392300). Setting: Forty-six sites in seven countries (the Czech Republic, Germany, Hungary, India, Poland, Russia, and the United States). Participants: Subjects (aged 18e80 years) with upper-limb post-stroke spasticity, who completed the 12-week main period of the phase 3 trial. Interventions: Subjects received 3 incobotulinumtoxinA treatments (400U), injected into the affected muscles of one upper-limb at fixed 12-week intervals. Main Outcome Measure(s): Outcome measures included: evaluation of muscle tone (Ashworth Scale (AS); Disability Assessment Scale (DAS); Carer Burden Scale; and incidence of adverse events (AEs). Results: In total, 248 subjects completed the OLEX. Proportions of subjects with 1 point improvement in AS score in each cycle ranged from 52.3%e 59.2% for wrist flexors, 49.1%e52.3% for elbow flexors, 59.8%e64.5% for finger flexors, 35.5%e41.2% for thumb flexors, and 37.4%e39.9% for forearm pronators (P<0.0001 for all). The mean DAS score for the principal target domain significantly improved from each incobotulinumtoxinA treatment to the respective 4-week assessment (P<0.0001 for all). Significant improvements in Carer Burden Scale scores were observed for cleaning palm, cutting fingernails, and putting arm through sleeve (P<0.0001 for all). Treatmentrelated AEs were reported by 9/296 subjects (3.0%), most frequently pain in the extremity (nZ2, 0.7%) and constipation (nZ2, 0.7%). Serious AEs were reported by 22 subjects (7.4%); none were treatment-related. Conclusions: Repeated incobotulinumtoxinA treatment was well-tolerated, significantly reduced upper-limb spasticity, and led to significant improvements in muscle tone that translated into meaningful clinical improvements in disability and carer burden. Key Words: Muscle spasticity, Botulinum Toxin Type A, IncobotulinumtoxinA Disclosures: Christina Marciniak, Michael Munin, and Elie Elovic have received support as investigators for Merz. Angelika Hanschmann and Reinhard Hiersemenzel are employees of Merz.
Oral Presentation 464 Randomized, Placebo-Controlled, Phase III Study of Incobotulinumtoxina for Upper-Limb Post-Stroke Spasticity Atul Patel (Kansas City Bone and Joint Clinic), Christina Marciniak, Michael C. Munin, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic Research Objectives: To study efficacy and safety of incobotulinumtoxinA for upper-limb post-stroke spasticity. Design: Prospective, multicenter, randomized, double-blind, placebocontrolled, parallel-group study evaluated subjects over 12-weeks following a single treatment of incobotulinumtoxinA (400U) or placebo. Setting: Forty-six sites in seven countries (the Czech Republic, Germany, Hungary, India, Poland, Russia, and the United States). Participants: Subjects (aged 18e80 years) with upper-limb post-stroke spasticity and a flexed elbow, flexed wrist and clenched fist clinical pattern of spasticity with a muscle tone of 2 on Ashworth Scale (AS) at each site were eligible to enroll. Interventions: Investigators treated the primary target clinical pattern (PTCP) with a fixed dose (flexed elbow: 200U, flexed wrist: 150U, clenched fist: 100U). Doses for other muscles were flexible.
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Oral Research Presentations Main Outcome Measure(s): The primary outcome was the change from baseline in PTCP AS score at Week 4. The co-primary outcome was the Investigator’s Global Impression of Change Scale (GICS) at Week 4. Results: The full analysis set included 259 subjects (incobotulinumtoxinAZ171; placeboZ88). At Week 4, incobotulinumtoxinA resulted in greater improvements in PTCP AS scores [least square mean standard error: -0.90.06 vs -0.50.08 for placebo (PZ0.001)] and more PTCP AS responders (1-point improvement) with incobotulinumtoxinA treatment (69.6% vs 37.5%; PZ0.001). Mean Investigator’s GICS was 1.20.07 for incobotulinumtoxinA vs 0.90.09 for placebo (PZ0.003). The safety evaluation set included 317 subjects. Adverse events (AEs) were mostly mild/moderate and reported by 22.4% and 16.8% of incobotulinumtoxinA and placebo subjects, respectively. AEs of special interest occurred in 3.3% (incobotulinumtoxinA) and 2.8% (placebo) subjects; the most frequent was dry mouth (incobotulinumtoxinA, 1.9%; placebo, 0.9%). There were no serious treatment-related AEs. Conclusions: IncobotulinumtoxinA is well-tolerated and significantly reduces upper-limb spasticity. Key Words: Muscle spasticity, Botulinum Toxin Type A, IncobotulinumtoxinA Disclosures: Atul Patel, Christina Marciniak, Michael Munin, and Elie Elovic received support as investigators for Merz. Angelika Hanschmann and Reinhard Hiersemenzel are employees of Merz. Oral Presentation 471 Engagement Trajectories and Outcomes in SCI Rehabilitation for Patients Receiving Inpatient Occupational Therapy Alex Wong (Washington University School of Medicine), Christina Papadimitriou, Gale Whiteneck, Anne Deutsch, Allen Heinemann, Arielle Goldsmith, Katrina Christopher, Christopher Focht, Eric Lenze Research Objectives: To examine the degree of engagement and its predictors for patients with SCI receiving occupational therapy (OT); and explore engagement trajectories associated with rehabilitation outcomes at discharge and 1-year post-injury. Design: Secondary analysis of multi-site SCIRehab data of patients receiving OT during inpatient rehabilitation. We used latent class growth analysis to identify engagement trajectories followed by regression models to identify predictors of trajectories, and examine the impact of trajectories on rehabilitation outcomes. Setting: Six rehabilitation facilities in Englewood, Atlanta, Chicago, Charlotte, New York, and Washington. Participants: 1375 patients with SCI receiving inpatient rehabilitation were assessed on their degree of active participation (engagement) in each OT session from admission to discharge using the Pittsburg Rehabilitation Participation Scale. Interventions: OT in inpatient SCI rehabilitation. Main Outcome Measure(s): Measures of motor and cognition function, participation, life satisfaction, presence of pressure sore, place of residence, and re-hospitalization. Results: We identified 4 trajectories of patient engagement: recovery (10%), slow-deteriorating (19%), fast-deteriorating (4%), and high-stable (67%). Cognitive function measured at admission, co-morbidity, days from injury to rehabilitation admission, and rehabilitation length of stay predicted trajectories (Likelihood Ratio Test: c2(51)Z 236.09, p<0.001). Engagement trajectories over the course of OT sessions predicted motor function, physical independence, life satisfaction, presence of pressure sore, discharge to home, and re-hospitalization (all p<0.05). Conclusions: Trajectories of engagement are associated with functional and participation outcomes at discharge and at 1-year after injury. Future research should identify strategies to identify at-risk patients who have poor rehabilitation engagement, and design interventions to optimize patient engagement into therapy for improved effectiveness. Key Words: Engagement, Spinal Cord Injury, Occupational Therapy Disclosures: None Disclosed.
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e11 Oral Presentation 486 NIDILRR: Allied Health Referral Variability and Outcomes for People with Parkinson’s Disease: National Parkinson Foundation Quality Improvement Initiative (NPF-QII) Data Miriam Rafferty (Northwestern University Center for Education in Health Science), Angela Roberts, Peter N. Schmidt, Sheng T. Luo, Kan Li, Tanya Simuni, NPF Quality Improvement Initiative Investigators Research Objectives: To (1) describe allied health referral variability for people with Parkinson’s disease (PD) across expert clinics and to (2) examine the association between referral rates and patient outcomes. Design: Investigators queried the data from the National Parkinson Foundation Quality Improvement Initiative (NPF-QII), a prospective, observational study of people with Parkinson’s disease. Setting: Twenty expert movement disorders neurology clinics in four countries. Participants: People with PD (nZ4976) enrolled in the NPF-QII study with at least two visits. Interventions: Not applicable. Main Outcome Measure(s): The primary objective of the NPF-QII is to identify potential best clinical practices in people with PD using the Parkinson’s Disease Questionnaire-39, timed up and go, cognition, hospitalizations, and caregiver strain. We observed self-reported referral to physical therapy (PT), occupational therapy (OT), and speech therapy (ST) in the past year, recorded at the second NPF-QII visit. Then we combined the 4 patient-oriented measures into a global outcome z-score, with risk adjustment, to compare referral rates at high and low ranking sites. Results: Average referral rates for PT, OT, and ST were 40.7%, 12.0%, and 14.4%, respectively. Referral rates increased with increased disease severity for all disciplines (p<0.0001), but were highly variable in each Hoehn and Yahr stage. Controlling for clinic size, the top performing sites (nZ10) had more PT referrals and less OT referrals than the bottom 10 sites (PT: 40.8% to 37.0%, pZ0.007; OT: 10.1% to 14.4%, p<0.0001), with a larger difference in early to moderate PD. Conclusions: More referrals in advanced PD suggests a prevalence of reactive, rather than preventive referrals. Higher rates of early PT referral at higher performing sites suggests that the earlier, possibly preventive, PT referrals may be associated with better clinic or patient outcomes. Key Words: Physical Therapy Modalities, Occupational Therapy, Speech Therapy, Parkinson Disease, Disclosures: Miriam Rafferty, Tanya Simuni, Sheng Luo and Kan Li have received grant money, travel stipends, and/or honorarium from the National Parkinson Foundation for their work collecting and analyzing the National Parkinson Foundation data. Peter Schmidt is employed by. Oral Presentation 499 A Demographic Analysis of the Barriers and Supporters of Enrollment for Traumatic Brain Injury Model Systems (TBIMS) Research Ellen Hada (New York University Langone Medical - Rusk Rehabilitation), Michael Juszczak, Coralynn Long, Michelle Smith, Shaina Shagalow, Tamara Bushnik Research Objectives: This study analysis examines the underlying barriers and facilitators to research recruitment within the protocol-eligible vulnerable population of the Traumatic Brain Injury Model Systems (TBIMS) research study. The difficulties behind TBI research lies in its more complicated, difficult to consent, yet eligible participants, such as those of multiple vulnerable group memberships (i.e., non-domicile, minority), those with cognitive impairments, and those lacking social support. This study seeks not only to address the question of research possible selection bias, but also identify possible risk and support factors influencing study enrollment. Design: Utilized data collected through TBI Model Systems (TBIMS) Form I & II interviews and additional interview at first year post-injury follow up.
Oral Presentation 450 Safety and Efficacy of Increasing Doses of IncobotulinumtoxinA (400U-800U) for Upper and Lower Limb Spasticity: The Phase III TOWER Study John McGuire (Medical College of Wisconsin), Jo¨rg Wissel, Djamel Bensmail, Astrid Scheschonka, Olivier Simon, David M. Simpson Research Objectives: Patients with severe multifocal spasticity may benefit from botulinum toxin treatment at higher doses. This study evaluated the safety and efficacy of increasing incobotulinumtoxinA doses (400U-800U) for patients with spasticity. Design: Prospective, single-arm, dose-titration study (NCT01603459). Setting: Thirty sites in 8 countries (Norway, Germany, Spain, Italy, France, Portugal, Canada, and the United States). Participants: Adult patients (aged 18-80 years) with spastic hemiparesis due to cerebral causes. Interventions: Patients received 3 consecutive injection cycles (ICs) with 400U, 600U, and 600-800U incobotulinumtoxinA, respectively, each followed by 12-16 weeks of observation. Main Outcome Measure(s): Outcome measures included adverse events (AEs), Resistance to Passive Movement Scale (REPAS, based on the Ashworth Scale), Goal Attainment Scale, and EuroQoL 5-dimensions (EQ-5D) questionnaire. Results: In total, 155 patients were enrolled. IncobotulinumtoxinA dose escalation did not lead to an increased incidence of AEs (IC1:36.1%; IC2:37.5%; IC3:25.7%). The most frequent AEs were falls (7.7%), nasopharyngitis, arthralgia, and diarrhea (6.5% each). No treatment-related serious AEs occurred; 5 patients (3.2%) discontinued due to AEs. The mean (standard deviation [SD]) change in REPAS score from each injection to 4 weeks post-injection increased throughout the study (IC1:-4.6 [3.9]; IC2:-5.9[4.2]; IC3:-7.1[4.8]; P<0.0001 for all). The proportion of patients achieving 3 out of 4 treatment goals increased throughout the study (IC1: 25.2%; IC2: 50.7%; IC3: 68.6%). Mean (SD) EQ-5D QoL scores improved from 59.9 (18.9) at baseline to 69.7 (17.6) at the end of study visit (P<0.0001). Conclusions: Increasing incobotulinumtoxinA doses (400U up to 800U) enabled treatment in a greater number of muscles, leading to increased treatment efficacy resulting in improved muscle tone, individual goal attainment, and quality of life, without compromising patients’ safety or tolerability. Key Words: Muscle spasticity, Botulinum Toxin Type A, IncobotulinumtoxinA Disclosures: John McGuire, Jo¨rg Wissel, Djamel Bensmail, and David M. Simpson received support as investigators from Merz. Astrid Scheschonka and Olivier Simon are employees of Merz.
Oral Research Presentations Oral Presentation 459 Efficacy and Safety of Repeated Incobotulinumtoxina Injections for Upper-Limb Post-Stroke Spasticity Christina Marciniak (Rehabilitation Institute of Chicago), Atul T. Patel, Michael C. Munin, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic Research Objectives: To investigate efficacy and safety of repeated incobotulinumtoxinA injections for upper-limb post-stroke spasticity. Design: A 36-week open-label extension (OLEX) of the randomized, doubleblind, placebo-controlled main period of a phase III trial (NCT01392300). Setting: Forty-six sites in seven countries (the Czech Republic, Germany, Hungary, India, Poland, Russia, and the United States). Participants: Subjects (aged 18e80 years) with upper-limb post-stroke spasticity, who completed the 12-week main period of the phase 3 trial. Interventions: Subjects received 3 incobotulinumtoxinA treatments (400U), injected into the affected muscles of one upper-limb at fixed 12-week intervals. Main Outcome Measure(s): Outcome measures included: evaluation of muscle tone (Ashworth Scale (AS); Disability Assessment Scale (DAS); Carer Burden Scale; and incidence of adverse events (AEs). Results: In total, 248 subjects completed the OLEX. Proportions of subjects with 1 point improvement in AS score in each cycle ranged from 52.3%e 59.2% for wrist flexors, 49.1%e52.3% for elbow flexors, 59.8%e64.5% for finger flexors, 35.5%e41.2% for thumb flexors, and 37.4%e39.9% for forearm pronators (P<0.0001 for all). The mean DAS score for the principal target domain significantly improved from each incobotulinumtoxinA treatment to the respective 4-week assessment (P<0.0001 for all). Significant improvements in Carer Burden Scale scores were observed for cleaning palm, cutting fingernails, and putting arm through sleeve (P<0.0001 for all). Treatmentrelated AEs were reported by 9/296 subjects (3.0%), most frequently pain in the extremity (nZ2, 0.7%) and constipation (nZ2, 0.7%). Serious AEs were reported by 22 subjects (7.4%); none were treatment-related. Conclusions: Repeated incobotulinumtoxinA treatment was well-tolerated, significantly reduced upper-limb spasticity, and led to significant improvements in muscle tone that translated into meaningful clinical improvements in disability and carer burden. Key Words: Muscle spasticity, Botulinum Toxin Type A, IncobotulinumtoxinA Disclosures: Christina Marciniak, Michael Munin, and Elie Elovic have received support as investigators for Merz. Angelika Hanschmann and Reinhard Hiersemenzel are employees of Merz.
Oral Presentation 464 Randomized, Placebo-Controlled, Phase III Study of Incobotulinumtoxina for Upper-Limb Post-Stroke Spasticity Atul Patel (Kansas City Bone and Joint Clinic), Christina Marciniak, Michael C. Munin, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic Research Objectives: To study efficacy and safety of incobotulinumtoxinA for upper-limb post-stroke spasticity. Design: Prospective, multicenter, randomized, double-blind, placebocontrolled, parallel-group study evaluated subjects over 12-weeks following a single treatment of incobotulinumtoxinA (400U) or placebo. Setting: Forty-six sites in seven countries (the Czech Republic, Germany, Hungary, India, Poland, Russia, and the United States). Participants: Subjects (aged 18e80 years) with upper-limb post-stroke spasticity and a flexed elbow, flexed wrist and clenched fist clinical pattern of spasticity with a muscle tone of 2 on Ashworth Scale (AS) at each site were eligible to enroll. Interventions: Investigators treated the primary target clinical pattern (PTCP) with a fixed dose (flexed elbow: 200U, flexed wrist: 150U, clenched fist: 100U). Doses for other muscles were flexible.
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Oral Research Presentations Main Outcome Measure(s): The primary outcome was the change from baseline in PTCP AS score at Week 4. The co-primary outcome was the Investigator’s Global Impression of Change Scale (GICS) at Week 4. Results: The full analysis set included 259 subjects (incobotulinumtoxinAZ171; placeboZ88). At Week 4, incobotulinumtoxinA resulted in greater improvements in PTCP AS scores [least square mean standard error: -0.90.06 vs -0.50.08 for placebo (PZ0.001)] and more PTCP AS responders (1-point improvement) with incobotulinumtoxinA treatment (69.6% vs 37.5%; PZ0.001). Mean Investigator’s GICS was 1.20.07 for incobotulinumtoxinA vs 0.90.09 for placebo (PZ0.003). The safety evaluation set included 317 subjects. Adverse events (AEs) were mostly mild/moderate and reported by 22.4% and 16.8% of incobotulinumtoxinA and placebo subjects, respectively. AEs of special interest occurred in 3.3% (incobotulinumtoxinA) and 2.8% (placebo) subjects; the most frequent was dry mouth (incobotulinumtoxinA, 1.9%; placebo, 0.9%). There were no serious treatment-related AEs. Conclusions: IncobotulinumtoxinA is well-tolerated and significantly reduces upper-limb spasticity. Key Words: Muscle spasticity, Botulinum Toxin Type A, IncobotulinumtoxinA Disclosures: Atul Patel, Christina Marciniak, Michael Munin, and Elie Elovic received support as investigators for Merz. Angelika Hanschmann and Reinhard Hiersemenzel are employees of Merz. Oral Presentation 471 Engagement Trajectories and Outcomes in SCI Rehabilitation for Patients Receiving Inpatient Occupational Therapy Alex Wong (Washington University School of Medicine), Christina Papadimitriou, Gale Whiteneck, Anne Deutsch, Allen Heinemann, Arielle Goldsmith, Katrina Christopher, Christopher Focht, Eric Lenze Research Objectives: To examine the degree of engagement and its predictors for patients with SCI receiving occupational therapy (OT); and explore engagement trajectories associated with rehabilitation outcomes at discharge and 1-year post-injury. Design: Secondary analysis of multi-site SCIRehab data of patients receiving OT during inpatient rehabilitation. We used latent class growth analysis to identify engagement trajectories followed by regression models to identify predictors of trajectories, and examine the impact of trajectories on rehabilitation outcomes. Setting: Six rehabilitation facilities in Englewood, Atlanta, Chicago, Charlotte, New York, and Washington. Participants: 1375 patients with SCI receiving inpatient rehabilitation were assessed on their degree of active participation (engagement) in each OT session from admission to discharge using the Pittsburg Rehabilitation Participation Scale. Interventions: OT in inpatient SCI rehabilitation. Main Outcome Measure(s): Measures of motor and cognition function, participation, life satisfaction, presence of pressure sore, place of residence, and re-hospitalization. Results: We identified 4 trajectories of patient engagement: recovery (10%), slow-deteriorating (19%), fast-deteriorating (4%), and high-stable (67%). Cognitive function measured at admission, co-morbidity, days from injury to rehabilitation admission, and rehabilitation length of stay predicted trajectories (Likelihood Ratio Test: c2(51)Z 236.09, p<0.001). Engagement trajectories over the course of OT sessions predicted motor function, physical independence, life satisfaction, presence of pressure sore, discharge to home, and re-hospitalization (all p<0.05). Conclusions: Trajectories of engagement are associated with functional and participation outcomes at discharge and at 1-year after injury. Future research should identify strategies to identify at-risk patients who have poor rehabilitation engagement, and design interventions to optimize patient engagement into therapy for improved effectiveness. Key Words: Engagement, Spinal Cord Injury, Occupational Therapy Disclosures: None Disclosed.
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e11 Oral Presentation 486 NIDILRR: Allied Health Referral Variability and Outcomes for People with Parkinson’s Disease: National Parkinson Foundation Quality Improvement Initiative (NPF-QII) Data Miriam Rafferty (Northwestern University Center for Education in Health Science), Angela Roberts, Peter N. Schmidt, Sheng T. Luo, Kan Li, Tanya Simuni, NPF Quality Improvement Initiative Investigators Research Objectives: To (1) describe allied health referral variability for people with Parkinson’s disease (PD) across expert clinics and to (2) examine the association between referral rates and patient outcomes. Design: Investigators queried the data from the National Parkinson Foundation Quality Improvement Initiative (NPF-QII), a prospective, observational study of people with Parkinson’s disease. Setting: Twenty expert movement disorders neurology clinics in four countries. Participants: People with PD (nZ4976) enrolled in the NPF-QII study with at least two visits. Interventions: Not applicable. Main Outcome Measure(s): The primary objective of the NPF-QII is to identify potential best clinical practices in people with PD using the Parkinson’s Disease Questionnaire-39, timed up and go, cognition, hospitalizations, and caregiver strain. We observed self-reported referral to physical therapy (PT), occupational therapy (OT), and speech therapy (ST) in the past year, recorded at the second NPF-QII visit. Then we combined the 4 patient-oriented measures into a global outcome z-score, with risk adjustment, to compare referral rates at high and low ranking sites. Results: Average referral rates for PT, OT, and ST were 40.7%, 12.0%, and 14.4%, respectively. Referral rates increased with increased disease severity for all disciplines (p<0.0001), but were highly variable in each Hoehn and Yahr stage. Controlling for clinic size, the top performing sites (nZ10) had more PT referrals and less OT referrals than the bottom 10 sites (PT: 40.8% to 37.0%, pZ0.007; OT: 10.1% to 14.4%, p<0.0001), with a larger difference in early to moderate PD. Conclusions: More referrals in advanced PD suggests a prevalence of reactive, rather than preventive referrals. Higher rates of early PT referral at higher performing sites suggests that the earlier, possibly preventive, PT referrals may be associated with better clinic or patient outcomes. Key Words: Physical Therapy Modalities, Occupational Therapy, Speech Therapy, Parkinson Disease, Disclosures: Miriam Rafferty, Tanya Simuni, Sheng Luo and Kan Li have received grant money, travel stipends, and/or honorarium from the National Parkinson Foundation for their work collecting and analyzing the National Parkinson Foundation data. Peter Schmidt is employed by. Oral Presentation 499 A Demographic Analysis of the Barriers and Supporters of Enrollment for Traumatic Brain Injury Model Systems (TBIMS) Research Ellen Hada (New York University Langone Medical - Rusk Rehabilitation), Michael Juszczak, Coralynn Long, Michelle Smith, Shaina Shagalow, Tamara Bushnik Research Objectives: This study analysis examines the underlying barriers and facilitators to research recruitment within the protocol-eligible vulnerable population of the Traumatic Brain Injury Model Systems (TBIMS) research study. The difficulties behind TBI research lies in its more complicated, difficult to consent, yet eligible participants, such as those of multiple vulnerable group memberships (i.e., non-domicile, minority), those with cognitive impairments, and those lacking social support. This study seeks not only to address the question of research possible selection bias, but also identify possible risk and support factors influencing study enrollment. Design: Utilized data collected through TBI Model Systems (TBIMS) Form I & II interviews and additional interview at first year post-injury follow up.