8 results
TeleSCOPE: A Real-World Study of Telehealth for the Detection and Treatment of Drug-Induced Movement Disorders
- Rimal Bera, Ericha Franey, Kendra Martello, Morgan Bron, Chuck Yonan
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- Journal:
- CNS Spectrums / Volume 27 / Issue 2 / April 2022
- Published online by Cambridge University Press:
- 28 April 2022, p. 250
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Introduction
As a result of COVID-19, patients and clinicians rapidly shifted to telehealth. An observational survey study, Real-World Tele-Health Evaluation of Tardive Dyskinesia (TD) Symptoms Communication/Observation Procedure Evaluation in Outpatient Clinical Settings (TeleSCOPE), was conducted to better understand how this shift affected the evaluation of drug-induced movement disorders (DIMDs), including TD.
MethodsTwenty-minute online quantitative surveys were conducted with neurology and psychiatry specialists (physicians and advanced practice providers) who met the following criteria: ≥3 years of practice with ≥70% of time spent in a clinic; prescribed a vesicular monoamine transporter 2 (VMAT2) inhibitor or benztropine for DIMD at least once in the past 6 months; and conducted telehealth visits with ≥15% of their patients from December 2020 to January 2021.
ResultsRespondents included 277 clinicians (neurology = 109, psychiatry = 168). Telehealth visits increased after COVID-19, with significantly greater increases in psychiatry vs neurology: phone (38% vs 21%); video (49% vs 42%). Across both specialties, top drivers/prompts for further DIMD evaluation were as follows: mention of tics or movements by family members or others (86%); trouble with gait, falls, walking, or standing (82%); difficulty swallowing or eating (74%); and difficulty writing, using phone, computer (71%). However, in the 6 months prior to June 2021, virtual evaluation, diagnosis, and monitoring of patients were challenging. For both specialties, many at-risk patients (ie, taking a dopamine receptor blocking agent) were not evaluated for DIMDs via video-based visits (psychiatry = 45%, neurology = 70%) or phone-only visits (psychiatry = 76%, neurology = 91%). Clinicians listed evaluation of gait/falls/walking/standing as the most challenging aspect of virtual assessment for phone-only visits (psychiatry = 53%, neurology = 57%) and video-based visits (psychiatry = 26%, neurology = 31%). Additional challenges included limited access to computers, insufficient training for clinicians and staff, and greater difficulty obtaining reimbursements (especially for complex telehealth visits). Patients without a participating caregiver, along with lower functioning patients, were at the highest risk of a missed DIMD diagnosis.
ConclusionsDuring the COVID-19 pandemic, telehealth significantly reduced clinicians’ ability or willingness to evaluate, diagnose, and monitor DIMDs. Clinicians stated multiple factors increased the risk of a missed or incorrect diagnosis. Challenges to optimal telehealth effectiveness included lack of patient access to computers, need for more clinician/staff training, lack of awareness of coverage, need for sufficient fee reimbursement. In-person evaluation continues to be the gold standard for assessing and treating DIMDs. However, if telehealth is necessary, the use of specific questions and directions is recommended for better communication and more accurate assessments.
FundingNeurocrine Biosciences, Inc.
Concerns from Community Mental Health Center (CMHC) Patients Regarding Drug-Induced Movement Disorders: Impact on Functioning and Treatment Beliefs
- Allison Stiles, Ericha Franey, Edward Goldberg, Leslie Lundt, Chuck Yonan, Rahul Dhanda
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- Journal:
- CNS Spectrums / Volume 26 / Issue 2 / April 2021
- Published online by Cambridge University Press:
- 10 May 2021, p. 152
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Objective
Drug-induced movement disorders (DIMDs) may occur in patients treated with antipsychotics. The CommonGround Program supports the recovery and healing of psychiatric outpatients through tools which facilitate better patient-doctor communication regarding psychiatric symptoms, DIMDs, and the effectiveness of treatment.
MethodsPatients responses to CommonGround’s web-based waiting-room questionnaire were analyzed in patients who responded yes to having concerns about developing DIMDs (MD-YES) and those who responded no to this question (MD-NO). These groups were compared descriptively to assess the potential effects of DIMD concerns on self-reported functioning and beliefs about prescribed psychiatric medications.
ResultsOf 7874 responding patients, 312 (4.0%) and 7562 (96.0%) were in the MD-YES and MD-NO subgroups, respectively. A higher percentage of MD-YES patients reported poor / not so good ability to keep up with daily responsibilities (21.2% vs 15.2% vs MD-NO), along with low energy levels (37.1% vs 26.3% for MD-NO), bothersome thoughts/beliefs/fears (30.5% vs 16.0%), and nervousness/anxiety (35.3% vs 27.5%) all / most of the time. MD-YES patients were also more likely to wonder about stopping their medications (9.3% vs 0.6% for MD-NO) and were concerned about side effects such as sleepiness (31.4% vs 3.9%) and weight gain (37.2% vs 5.7%).
ConclusionPatients from community mental health centers who were concerned about developing DIMDs tended to express problems with daily functioning and concerns about their psychiatric medications. For these patients, recognizing their fears and concerns may help clinicians discuss treatment options for DIMDs, which could increase patient confidence, encourage adherence to current psychiatric medications, and potentially improve outcomes.
Clinician-Reported Patient Awareness of Symptoms and Severity of Tardive Dyskinesia in Patients Prescribed VMAT2 Inhibitors
- Jonathan M. Meyer, Ericha Franey, Leslie Lundt, Betsy Benning, Edward Goldberg, Chuck Yonan, Rahul Dhanda
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- Journal:
- CNS Spectrums / Volume 26 / Issue 2 / April 2021
- Published online by Cambridge University Press:
- 10 May 2021, p. 151
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Objective
Vesicular monoamine transporter 2 (VMAT2) inhibitors including valbenazine are first-line therapies for tardive dyskinesia (TD), a persistent movement disorder associated with antipsychotic exposure. This real-world study was performed to assess the association between patient awareness of TD symptoms and clinician-assessed symptom severity.
MethodsClinicians who treated antipsychotic-induced TD with a VMAT2 inhibitor within the past 24 months were asked to extract demographic/clinical data from patients charts and complete a survey for additional data, including patient awareness of TD (yes/no) and TD symptom severity (mild/moderate/severe).
ResultsData for 601 patients were provided by 163 clinicians (113 psychiatrists; 46 neurologists; 4 primary care physicians). Patient demographics: 50% male; mean age 50.6 years; 55% schizophrenia/schizoaffective disorder; 29% bipolar disorder; 16% other psychiatric diagnoses. Positive relationships were seen between patient awareness and clinician-assessed symptom severity. Awareness was highest in patients with severe symptoms in specific body regions: face (88% vs 78%/69% [awareness by severe vs moderate/mild symptoms]); jaw (90% vs 80%/67%); wrists (90% vs 69%/63%). In other regions, awareness was similar in patients with severe or moderate symptoms: lips (85%/86% vs 68% [severe/moderate vs mild]); tongue (81%/80% vs 73%); neck (80%/78% vs 68%); arms (67%/66% vs 62%); knees (67%/67% vs 53%).
ConclusionsIn patients prescribed a VMAT2 inhibitor for TD, patient awareness was generally higher in those determined to have moderate-to-severe symptom severity as assessed by the clinician. More research is needed to understand how awareness and severity contribute to TD burden, and whether different treatment strategies are needed based on these factors.
FundingNeurocrine Biosciences, Inc.
105 Health-Related Quality of Life in Patients with Possible Tardive Dyskinesia Based on Patient and Clinician Assessments
- Andrew J. Cutler, Stanley N. Caroff, Huda Shalhoub, William R. Lenderking, Ericha Franey, Chuck Yonan
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- Journal:
- CNS Spectrums / Volume 25 / Issue 2 / April 2020
- Published online by Cambridge University Press:
- 24 April 2020, pp. 268-269
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Study Objective:
Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged antipsychotic use. RE KINECT, a real-world screening study of antipsychotic-treated outpatients, included patients with movements that were clinician-confirmed as possible TD (Cohort 2) and patients with no involuntary movements (Cohort 1). Baseline data from the patient rated EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and Sheehan Disability Scale (SDS) were analyzed to evaluate health related quality of life (Cohort 2 vs. Cohort 1) and the effects of possible TD on quality of life (Cohort 2).
Methods:Assessments included EQ-5D-5L utility score (0=equivalent to death to 1=perfect health); SDS total score (0=no impact to 30=highest impact); patient- and clinician-rated severity of possible TD in 4 body regions (0=none, 1=some, and 2=a lot; summary score, 0 to 8); and patient-rated impact of possible TD in 7 daily activities (0=none, 1=some, and 2=a lot; summary score, 0 to 14). Populations included Cohort 1 (N=450); full Cohort 2 (N=204); and limited Cohort 2 (N=111, patients who self-reported “some” or “a lot” of TD severity in ≥1 body region). Mean differences between Cohort 2 and Cohort 1 in EQ-5D-5L utility and SDS total scores were analyzed using a generalized linear regression model that was adjusted for potentially confounding factors (e.g., age, sex, psychiatric diagnosis). Associations between TD summary scores (severity, impact) and quality of life (EQ-5D-5L utility, SDS total) were analyzed using a regression model.
Results:The mean score difference between full Cohort 2 (N=204) and Cohort 1 (N=450) was significant for EQ-5D-5L utility (-0.037; P<0.05 [adjusted analysis]) but not SDS total (0.267; P>0.05). However, when limited to Cohort 2 patients who self-reported “a lot” of TD severity (n=53) or impact (n=33), both EQ 5D 5L utility and SDS total scores were significantly worse than in Cohort 1 (P<0.05). Regression coefficients indicated significant associations between patient-rated impact and EQ 5D-5L utility in the full Cohort 2 (-0.021, P<0.001) and limited Cohort 2 (-0.024, P<0.001). A significant association was also found with patient rated severity in limited Cohort 2 (P<0.05), but not with clinician-rated severity. Similar results were found for SDS total score.
Conclusions:RE-KINECT patients were consistent in evaluating the severity and impact of TD, whether based on subjective assessments or standardized patient-reported instruments (EQ-5D-5L, SDS). Clinician-rated severity of TD may not always correlate with patient perceptions of the significance of TD. Patient self-assessments (focused on symptom impact) can be clinically relevant; incorporating such measures into everyday practice may provide a more comprehensive approach to TD assessment and management.
Funding Acknowledgements:Supported by Neurocrine Biosciences, Inc.
6 Presence and Impact of Possible Tardive Dyskinesia in Patients Prescribed Antipsychotics: Results from the RE-KINECT Study
- Andrew J. Cutler, Stanley N. Caroff, Caroline M. Tanner, Huda Shalhoub, William R. Lenderking, Jun Chen, Karen Yeomans, Ericha Anthony, Chuck Yonan
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, pp. 176-177
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Objective
Tardive dyskinesia (TD) is a hyperkinetic movement disorder associated with antipsychotic treatment. RE KINECT (NCT03062033), a real-world study of outpatients prescribed antipsychotics, was designed to identify the presence of possible TD and characterize the impact of involuntary movements on functioning and quality of life. Data from RE-KINECT were used to compare the impact of possible TD in patients with schizophrenia/schizoaffective disorder [SZD] versus mood/other psychiatric disorders [Mood].
MethodsAdults with ≥3months of lifetime exposure to antipsychotics and ≥1 psychiatric disorder were recruited. The presence of possible TD was based on clinicians’ observation of involuntary movements in 4 body regions (head, trunk, upper extremities, and lower extremities). Baseline outcomes included demographics, medication history, location/severity of abnormal movements, impact of abnormal movements on daily activities, the Sheehan Disability Scale (SDS), and the EuroQoL 5-Dimensional questionnaire (EQ-5D-5L).
ResultsOf 204 patients with clinician-confirmed possible TD, 111 (54.4%) had a SZD diagnosis and 93 (45.6%) had a mood/other psychiatric diagnosis. Significant differences found between groups (Mood vs SZD) included: mean age (56.9 vs 52.7 years; P=0.0263); male sex (33.3% vs 62.2%; P<0.0001); African-American race (7.5% vs 26.1%; P=0.0005); mean lifetime exposure to antipsychotics (9.5 vs 19.5 years; P<0.0001); and percentage of patients currently taking ≥2 psychiatric medications (93.5% vs 79.3%; P=0.0093). Based on clinician observation, there were no significant differences between diagnosis groups in the number of body regions impacted by abnormal movements, maximum severity score across all 4 regions, or patient awareness of possible TD. Over 30% of patients in both groups reported that involuntary movements had “some” or “a lot” of impact on their ability to continue usual activities, be productive, and socialize. No significant differences between the diagnosis groups (Mood vs SZD) were found for mean SDS total score (12.8 vs 10.8), SDS domain scores (work/school [4.1 vs 4.2], social life [4.3 vs 3.7], family life [4.1 vs 3.5]), EQ-5D-5L utility score (0.68 vs 0.74), or EQ-5D-5L health state VAS (64.8 vs 68.5).
ConclusionsIn this cohort of outpatients with possible TD, those with Mood disorders were more likely to be older, female, and white than patients with SZD. The ability to function and quality of life were equally impaired in both groups. Further studies on the impact of TD are needed.
Funding Acknowledgements: Neurocrine Biosciences, Inc.
38 Global Improvement and Patient Satisfaction: Results from a Long-term, Open-label, Rollover Study of Valbenazine in Tardive Dyskinesia
- Cherian Verghese, Jean-Pierre Lindenmayer, Stephen R. Marder, Joshua Burke, Roland Jimenez, Chuck Yonan, Khody Farahmand, Scott Siegert
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, pp. 195-196
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Objective
Valbenazine (VBZ) is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor approved to treat tardive dyskinesia (TD) in adults. It has been evaluated in 2 long-term studies (KINECT 3, KINECT 4) in which participants received VBZ (40 or 80mg) for up to 48weeks. This long-term rollover study (NCT02736955) was conducted to evaluate global TD improvement and patient satisfaction with once-daily VBZ.
MethodsKey eligibility criteria: age 18 to 85 years; completion of KINECT 3 or KINECT 4; maintenance medications (for schizophrenia, schizoaffective disorder, or mood disorder) at stable doses; Brief Psychiatric Rating Scale score <50; no significant risk of active suicidal ideation or behavior. Following washout of prior VBZ treatment (Weeks 48 to 52 of KINECT 3 and KINECT 4), participants were re-initiated at 40mg (4weeks) and escalated to 80mg based on tolerability and clinical assessment of TD; dose was reduced to 40mg if 80mg was not tolerated (80/40mg). If unable to tolerate the 40mg dose, the participant was discontinued. Participants received open-label VBZ for up to 72weeks or until commercial availability. Assessments included Clinical Global Impression of Severity-TD (CGIS-TD: range, 1[“normal, not at all ill”] to 7[“among the most extremely ill patient”]) and Patient Satisfaction Questionnaire (PSQ: range, 1[“very satisfied”] to 5[“very dissatisfied”]).
Results160 participants with available data were included in analyses (40mg =35; 80mg =117; 80/40mg =8); 138 were receiving treatment when VBZ became commercially available. The percentages of participants who completed visits at Wks 12, 24, 36, and 48 were 96.3%, 78.1%, 56.9% and 35.0%, respectively. Few reached Wk 60 (n=4) or Wk 72 (n=0) due to commercial availability. The percentage of participants with CGIS-TD score ≤2 (“normal, not at all ill” or “borderline ill”) increased from baseline (before restarting VBZ) (40mg, 5.7%; 80mg, 18.1%) to Wk 48 (40mg , 41.7%; 80mg , 74.4%). At baseline, almost all participants rated their prior VBZ experience with a PSQ score ≤2 (“very satisfied” or “somewhat satisfied”) (40mg , 100%, 80mg , 99.1%). Similar results were seen at the Wk 48 visit, with most participants continuing to express satisfaction with VBZ (40mg , 100%; 80mg , 97.4%).
ConclusionsA clinician-based global assessment indicated ongoing, meaningful TD improvements in adults who received once-daily VBZ in the current study. In participants treated for >1 year, continued patient satisfaction rates with VBZ were high.
Funding Acknowledgements: Neurocrine Biosciences, Inc.
118 Demographics and Real World Healthcare Cost and Utilization for Patients With Probable Tardive Dyskinesia
- Michael Polson, Chuck Yonan, Ted Williams
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- Journal:
- CNS Spectrums / Volume 23 / Issue 1 / February 2018
- Published online by Cambridge University Press:
- 15 June 2018, p. 75
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Background
Tardive dyskinesia (TD) is a movement disorder associated with prolonged exposure to antipsychotics. The current study was designed to describe demographics and comorbidities for patients with a dyskinesia diagnosis as probable TD (cohort 1), patients likely to have undiagnosed/uncoded TD (cohort 2), and a control population.
MethodsThis retrospective study analyzed Medicaid claims data from July 2013-March 2017. For a pool of patients with a history of 3 months or more of taking an antipsychotic, three cohorts were evaluated: cohort 1 (ICD-9/10 codes for dyskinesia); cohort 2 (propensity score matching to cohort 1); and cohort 3 (patients withschizophrenia, major depressive disorder [MDD], and/or bipolar disorder [BD] and history of ≤2 antipsychotic medications). Outcomes included patient characteristics, Charlson Comorbity Index (CCI) and healthcare utilization (pre-and post [12-month] period).
ResultsCohort sizes and characteristics were: cohort 1 (n=1,887; female, 68%; mean age, 42 years; MDD, 17%; BD, 48%); cohort 2 (n=1,572; female, 58%; mean age, 39 years; MDD, 22%; BD, 48%); cohort 3 (n=25,949; female, 67%; mean age, 40 years; MDD, 11%; BD, 49%). Cohorts 1 and 2 had higher comorbidity burden than cohort 3 (mean pre-index CCIs: 0.68, 0.79, and 0.47, respectively; p<0.001 for each cohort). After 12 months, mean per member per year healthcare costs were higher in cohort 1 and2 compared to cohort 3 ($21,293, $18,988, and $11,522, respectively), as were mean claims per member per year (185, 138, and 109, respectively).
ConclusionIn the study population, patients likely suffering from TD, ICD-9/10 code-confirmed or unconfirmed, have a higher overall comorbidity burden and healthcareutilization than those who probably do not have TD.
Funding AcknowledgementsThis study was funded by Neurocrine Biosciences, Inc.
117 RE-KINECT: Real-World Dyskinesia Screening Study and Registry in Patients Taking Antipsychotic Agents: Interim Baseline Burden of Illness Results
- Andrew Cutler, Stanley Caroff, Caroline Tanner, William R. Lenderking, Karen Yeomans, Huda Shalhoub, Véronique Pagé, Chuck Yonan
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- Journal:
- CNS Spectrums / Volume 23 / Issue 1 / February 2018
- Published online by Cambridge University Press:
- 15 June 2018, p. 74
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Background
Tardive dyskinesia (TD) is associated with prolonged exposure to dopamine receptor blockers including antipsychotics. This registry describes the prevalence and impact of involuntary movements (possible TD) in a real-world population of patients taking antipsychotics.
MethodsRE-KINECT (NCT03062033) aims to enroll 1,000 patients from 70 US psychiatric practices. Adults with ≥3 months lifetime exposure to antipsychotic(s) and ≥1 psychiatric disorder are eligible for two-tier screening: informal observation, and then clinician observation of abnormal involuntary movements in general body regions (head/face, neck/trunk, upper/lower limbs) and confirmation of possible TD. Based on clinician assessment, patients are assigned to Cohort 1 or Cohort 2 (without or with abnormal involuntary movements, respectively). In both cohorts, the following baseline assessments are included: clinician’s assessment of clinical psychiatric severity, patient perceived health‐related quality of life (EuroQOL 5-Dimensions), social burden/disability questionnaire (Sheehan Disability Scale), and 12-month retrospective chart review ofmedical and treatment history. Cohort 2 also participate in 12-month longitudinal evaluation. Interim baseline data are available from four sites.
ResultsBaseline data are currently available for 116 patients—mean age, 49.6 years; female, 60.3%; schizophrenia/schizoaffective disorder, 32.8%; at least 1 mood disorder, 84.5%, and 10.4 years mean cumulative lifetime exposure to antipsychotic(s). The most concerning health condition for both cohorts is their mental health (69.0%), followed by physical activity and nutrition (33.6%). 32.8% of subjects had clinician confirmation of possible TD.
ConclusionThis novel registry aims to evaluate the real-world potential impact/burden of TD. Preliminary analyses suggest that TD is common in patients with schizophrenia and mood disorders taking antipsychotics. Further analyses will explore the burden of illness in this population.
Funding AcknowledgementsThis study was funded by Neurocrine Biosciences, Inc.