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  1. Article ; Online: In Reply to Xue W, Ribalov R, Zhou Z-Y, et al. Re: Ganz ML, Chavan A, Dhanda R, et al. Cost-effectiveness of valbenazine compared with deutetrabenazine for the treatment of tardive dyskinesia. J Med Econ. 2021;24(1):103-113.

    Serbin, Michael / Yonan, Charles / Ganz, Michael L

    Journal of medical economics

    2021  Volume 24, Issue 1, Page(s) 891–892

    MeSH term(s) Antipsychotic Agents ; Cost-Benefit Analysis ; Humans ; Tardive Dyskinesia/drug therapy ; Tetrabenazine/analogs & derivatives ; Tetrabenazine/therapeutic use ; Valine/analogs & derivatives
    Chemical Substances Antipsychotic Agents ; valbenazine (54K37P50KH) ; Valine (HG18B9YRS7) ; deutetrabenazine (P341G6W9NB) ; Tetrabenazine (Z9O08YRN8O)
    Language English
    Publishing date 2021-06-24
    Publishing country England
    Document type Journal Article
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.1080/13696998.2021.1948233
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  2. Article ; Online: The Tardive Dyskinesia Impact Scale (TDIS), a novel patient-reported outcome measure in tardive dyskinesia: development and psychometric validation.

    Farber, Robert H / Stull, Donald E / Witherspoon, Brooke / Evans, Christopher J / Yonan, Charles / Bron, Morgan / Dhanda, Rahul / Jen, Eric / Brien, Christopher O '

    Journal of patient-reported outcomes

    2024  Volume 8, Issue 1, Page(s) 2

    Abstract: Background: Tardive dyskinesia (TD), a movement disorder in which patients experience abnormal involuntary movements, can have profound negative impacts on physical, cognitive, and psychosocial functioning. The Abnormal Involuntary Movement Scale (AIMS), ...

    Abstract Background: Tardive dyskinesia (TD), a movement disorder in which patients experience abnormal involuntary movements, can have profound negative impacts on physical, cognitive, and psychosocial functioning. The Abnormal Involuntary Movement Scale (AIMS), a clinician-rated outcome, is considered the gold standard for evaluating treatment efficacy in TD clinical trials. However, it provides little information about the impacts of uncontrolled movements from a patient perspective and can be cumbersome to administer in clinical settings. The Tardive Dyskinesia Impact Scale (TDIS) was developed as a patient-reported outcome measure to fulfill the need for a disease-specific impact assessment in TD. The objective of the present study was to develop and evaluate the psychometric properties of the TDIS to determine whether it is fit-for-purpose to measure TD impact.
    Methods: Data from qualitative studies and phase 3 trials of a VMAT2 inhibitor for the treatment of TD (KINECT3 and KINECT4) were used to determine the psychometric properties of the TDIS. Qualitative research included concept elicitation and cognitive debriefing interviews with TD patients and their caregivers in order to assess how well the TDIS captured key domains of TD impact. Quantitative analyses to examine the psychometric properties of the TDIS included assessing construct validity (factor structure, known groups, and predictive validity) and responsiveness to change.
    Results: Qualitative results showed that the TDIS captures the key TD impacts reported by patients and caregivers and that the TDIS was interpreted as intended and relevant to patients' experiences. Quantitative results found evidence of 2 underlying domains of the TDIS: physical and socioemotional (Comparative Fit Index > 0.9). Known groups and predictive validity indicated that, compared with the AIMS, the TDIS captures unique content (correlation between AIMS and TDIS = 0.2-0.28). The TDIS showed responsiveness to change in treatment, with TDIS scores improving over 48 weeks in the 2 phase 3 trials.
    Conclusions: The TDIS captures relevant information about the impact of TD and is easily administered in a clinician's office or patient's home. It may be used longitudinally to show changes in TD burden over time. The TDIS complements the AIMS; using these assessments together provides a more holistic assessment of TD.
    MeSH term(s) Humans ; Tardive Dyskinesia/diagnosis ; Psychometrics ; Dyskinesias ; Movement Disorders ; Patient Reported Outcome Measures
    Language English
    Publishing date 2024-01-04
    Publishing country Germany
    Document type Journal Article
    ISSN 2509-8020
    ISSN (online) 2509-8020
    DOI 10.1186/s41687-023-00679-4
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  3. Article: Patients' Preferences for Adjunctive Parkinson's Disease Treatments: A Discrete-Choice Experiment.

    Serbin, Michael / Marras, Connie / Mansfield, Carol / Leach, Colton / Yonan, Charles / Sheehan, Margaret / Donnelly, Anne / Klepitskaya, Olga

    Patient preference and adherence

    2023  Volume 17, Page(s) 2263–2277

    Abstract: Background: Several adjunctive medications are available to reduce OFF time between levodopa/carbidopa (LD/CD) doses for people with Parkinson's disease (PD).: Objective: To explore how individuals with PD balance benefits and burdens when ... ...

    Abstract Background: Several adjunctive medications are available to reduce OFF time between levodopa/carbidopa (LD/CD) doses for people with Parkinson's disease (PD).
    Objective: To explore how individuals with PD balance benefits and burdens when considering adjunctive medications.
    Methods: US adults (30-83 years) with self-reported PD, currently treated with LD/CD, who experienced OFF episodes were recruited through the Fox Insight study to complete a discrete-choice experiment survey. Respondents selected among experimentally designed profiles for hypothetical adjunctive PD treatments that varied in efficacy (additional ON time), potential adverse effects (troublesome dyskinesia, risk of diarrhea, risk of change in bodily fluid color), and dosing frequency or the option "No additional medicine". Data were analyzed with random-parameters logit models.
    Results: Respondents (N=480) would require ≥60 additional minutes of daily ON time to accept either a 40% risk of change in bodily fluid color or 10 additional minutes with troublesome dyskinesia daily. Respondents would require 40 additional minutes of daily ON time to accept a 10% risk of diarrhea and 22 additional minutes of daily ON time to switch from 1 additional pill each day to 1 pill with each LD/CD dose. On average, respondents preferred adjunctive PD medication over no additional medication. Results predicted that 59.1% of respondents would select a hypothetical treatment profile similar to opicapone, followed by no additional medication (27.5%) and a hypothetical treatment profile similar to entacapone (13.4%).
    Limitations: The data collected were based on responses to hypothetical choice profiles in the survey questions. The attributes and levels selected for this study were intended to reflect the characteristics of opicapone and entacapone; attributes associated with other adjunctive therapies were not evaluated.
    Conclusion: Patients with PD expressed interest in adjunctive treatment to increase ON time and would accept reduced ON time to avoid adverse effects.
    Language English
    Publishing date 2023-09-13
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2455848-5
    ISSN 1177-889X
    ISSN 1177-889X
    DOI 10.2147/PPA.S420051
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  4. Article ; Online: Cost-effectiveness of valbenazine compared with deutetrabenazine for the treatment of tardive dyskinesia.

    Ganz, Michael L / Chavan, Ameya / Dhanda, Rahul / Serbin, Michael / Yonan, Charles

    Journal of medical economics

    2021  Volume 24, Issue 1, Page(s) 103–113

    Abstract: Aims: To evaluate clinical and economic outcomes associated with valbenazine compared with deutetrabenazine in patients with tardive dyskinesia (TD) using a model that accounts for multiple dimensions of patient health status.: Materials and methods: ...

    Abstract Aims: To evaluate clinical and economic outcomes associated with valbenazine compared with deutetrabenazine in patients with tardive dyskinesia (TD) using a model that accounts for multiple dimensions of patient health status.
    Materials and methods: A discretely integrated condition event model was developed to evaluate the cost-effectiveness of treatment with valbenazine and deutetrabenazine in a synthetic cohort of 1,000 patients with TD who were receiving antipsychotic medication to treat an underlying psychiatric disorder. Clinical inputs were derived from relevant clinical trials or from publicly available sources. Patients were assessed over 1 year using ≥50% improvement from baseline in Abnormal Involuntary Movement Scale (AIMS) total score as the primary definition of response. Response at 1 year using Clinical Global Impression of Change (CGIC) score ≤2 was also assessed. Health outcomes included quality-adjusted life years (QALYs), life years, proportion responding to treatment at 1 year, and number of psychiatric relapses.
    Results: Regardless of the definition used for response, patients treated with valbenazine were more likely to have responded to treatment at 1 year, lived longer, and accrued more QALYs than patients who received deutetrabenazine. Using the AIMS response criterion, the incremental cost-effectiveness ratio was $9,951/QALY for valbenazine compared with deutetrabenazine. By comparison, using the CGIC response criterion valbenazine dominated deutetrabenazine with valbenazine-treated patients accumulating more QALYs (3.4 vs 3.3 years) and incurring lower lifetime costs ($252,311 vs $283,208) than deutetrabenazine-treated patients.
    Limitations: There are no head-to-head trials of valbenazine and deutetrabenazine, so probabilities of response used in the model were calculated based on an indirect treatment comparison of results from individual trials with one drug or the other, using only those metrics reported across trials.
    Conclusions: In patients with TD, treatment with valbenazine is highly cost-effective compared with deutetrabenazine.
    MeSH term(s) Cost-Benefit Analysis ; Humans ; Tardive Dyskinesia/drug therapy ; Tetrabenazine/analogs & derivatives ; Tetrabenazine/therapeutic use ; Valine/analogs & derivatives
    Chemical Substances valbenazine (54K37P50KH) ; Valine (HG18B9YRS7) ; deutetrabenazine (P341G6W9NB) ; Tetrabenazine (Z9O08YRN8O)
    Language English
    Publishing date 2021-01-04
    Publishing country England
    Document type Journal Article
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.1080/13696998.2020.1867443
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  5. Article ; Online: Treatment of tardive dyskinesia with tetrabenazine or valbenazine: a systematic review.

    Caroff, Stanley N / Aggarwal, Saurabh / Yonan, Charles

    Journal of comparative effectiveness research

    2017  Volume 7, Issue 2, Page(s) 135–148

    Abstract: Up to 30% of patients taking antipsychotics may develop tardive dyskinesia (TD). Recent evidence-based recommendations demonstrate an unmet need for effective TD management. This systematic review was designed to update the evidence for TD treatment, ... ...

    Abstract Up to 30% of patients taking antipsychotics may develop tardive dyskinesia (TD). Recent evidence-based recommendations demonstrate an unmet need for effective TD management. This systematic review was designed to update the evidence for TD treatment, comparing two vesicular monoamine transporter 2 (VMAT2) inhibitors, tetrabenazine and valbenazine. Of 487 PubMed/Embase search results, 11 studies met the review criteria. Valbenazine efficacy was demonstrated in rigorously designed clinical trials that meet the guidelines for AAN Class I evidence. Due to differences in study designs and a lack of standardized and controlled trials with tetrabenazine, a formal meta-analysis comparing the agents was not possible. However, valbenazine appears to have fewer side effects and a more favorable once-daily dosing regimen for the treatment of TD.
    MeSH term(s) Adrenergic Uptake Inhibitors/administration & dosage ; Adrenergic Uptake Inhibitors/adverse effects ; Antipsychotic Agents/administration & dosage ; Antipsychotic Agents/adverse effects ; Clinical Trials as Topic ; Drug Administration Schedule ; Humans ; Research Design ; Tardive Dyskinesia/drug therapy ; Tetrabenazine/administration & dosage ; Tetrabenazine/adverse effects ; Tetrabenazine/analogs & derivatives ; Valine/administration & dosage ; Valine/adverse effects ; Valine/analogs & derivatives ; Vesicular Monoamine Transport Proteins/antagonists & inhibitors
    Chemical Substances Adrenergic Uptake Inhibitors ; Antipsychotic Agents ; SLC18A1 protein, human ; Vesicular Monoamine Transport Proteins ; valbenazine (54K37P50KH) ; Valine (HG18B9YRS7) ; Tetrabenazine (Z9O08YRN8O)
    Language English
    Publishing date 2017-10-02
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
    ISSN 2042-6313
    ISSN (online) 2042-6313
    DOI 10.2217/cer-2017-0065
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  6. Article ; Online: Identification of pseudobulbar affect symptoms in the nursing home setting: Development and assessment of a screening tool.

    Allen, Carrie / Zarowitz, Barbara / O'Shea, Terrence / Peterson, Edward / Yonan, Charles / Waterman, Fanta

    Geriatric nursing (New York, N.Y.)

    2018  Volume 39, Issue 1, Page(s) 54–59

    Abstract: Pseudobulbar Affect (PBA) is a neurologic condition characterized by involuntary outbursts of crying and/or laughing disproportionate to patient mood or social context. Although an estimated 9% of nursing home residents have symptoms suggestive of PBA, ... ...

    Abstract Pseudobulbar Affect (PBA) is a neurologic condition characterized by involuntary outbursts of crying and/or laughing disproportionate to patient mood or social context. Although an estimated 9% of nursing home residents have symptoms suggestive of PBA, they are not routinely screened. Our goal was to develop an electronic screening tool based upon characteristics common to nursing home residents with PBA identified through medical record data. Nursing home residents with PBA treated with dextromethorphan hydrobromide/quinidine sulfate (n = 140) were compared to age-, gender-, and dementia-diagnosis-matched controls without PBA or treatment (n = 140). Comparative categories included diagnoses, medication use and symptom documentation. Using a multivariable regression and best decision rule analysis, we found PBA in nursing home residents was associated with chart documentation of uncontrollable crying, presence of a neurologic disorder (e.g., Parkinson's disease), or by the documented presence of at least 2 of the following: stroke, severe cognitive impairment, and schizophrenia. Based on these risk factors, an electronic screening tool was created.
    MeSH term(s) Aged ; Aged, 80 and over ; Cross-Sectional Studies ; Dextromethorphan/therapeutic use ; Drug Combinations ; Emotions ; Female ; Humans ; Male ; Middle Aged ; Nursing Homes ; Pseudobulbar Palsy/diagnosis ; Pseudobulbar Palsy/drug therapy ; Quinidine/therapeutic use ; Surveys and Questionnaires/utilization
    Chemical Substances Drug Combinations ; dextromethorphan - quinidine combination ; Dextromethorphan (7355X3ROTS) ; Quinidine (ITX08688JL)
    Language English
    Publishing date 2018-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632559-2
    ISSN 1528-3984 ; 0197-4572
    ISSN (online) 1528-3984
    ISSN 0197-4572
    DOI 10.1016/j.gerinurse.2017.06.002
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    Zs.B 2789: Show issues Location:
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  7. Article ; Online: Prevalence of pseudobulbar affect symptoms and clinical correlates in nursing home residents.

    Foley, Kevin / Konetzka, R Tamara / Bunin, Anthony / Yonan, Charles

    International journal of geriatric psychiatry

    2015  Volume 31, Issue 7, Page(s) 694–701

    Abstract: Objective: Pseudobulbar affect (PBA) is a neurological disorder of emotional expression, characterized by uncontrollable episodes of crying or laughing in patients with certain neurological disorders affecting the brain. The purposes of this study were ... ...

    Abstract Objective: Pseudobulbar affect (PBA) is a neurological disorder of emotional expression, characterized by uncontrollable episodes of crying or laughing in patients with certain neurological disorders affecting the brain. The purposes of this study were to estimate the prevalence of PBA in US nursing home residents and examine the relationship between PBA symptoms and other clinical correlates, including the use of psychopharmacological medications.
    Methods: A retrospective study was conducted between 2013 and 2014 with a convenience sample of residents from nine Michigan nursing homes. Chronic-care residents were included in the "predisposed population" if they had a neurological disorder affecting the brain and no evidence of psychosis, delirium, or disruptive behavior (per chart review). Residents were screened for PBA symptoms by a geropsychologist using the Center for Neurologic Study-Lability Scale (CNS-LS). Additional clinical information was collected using a diagnostic evaluation checklist and the most recent Minimum Data Set 3.0 assessment.
    Results: Of 811 residents screened, complete data were available for 804, and 412 (51%) met the criteria for the "predisposed population." PBA symptom prevalence, based on having a CNS-LS score ≥13, was 17.5% in the predisposed population and 9.0% among all nursing home residents. Those with PBA symptoms were more likely to have a documented mood disorder and be using a psychopharmacological medication, including antipsychotics, than those without PBA symptoms.
    Conclusions: Pseudobulbar affect symptoms were present in 17.5% of nursing home residents with neurological conditions, and 9.0% of residents overall. Increasing awareness and improving diagnostic accuracy of PBA may help optimize treatment. Copyright © 2015 John Wiley & Sons, Ltd.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antipsychotic Agents/therapeutic use ; Crying ; Female ; Humans ; Laughter ; Male ; Michigan/epidemiology ; Middle Aged ; Mood Disorders/drug therapy ; Mood Disorders/epidemiology ; Mood Disorders/etiology ; Nervous System Diseases/complications ; Nursing Homes/statistics & numerical data ; Prevalence ; Psychotropic Drugs/therapeutic use ; Retrospective Studies
    Chemical Substances Antipsychotic Agents ; Psychotropic Drugs
    Language English
    Publishing date 2015-11-02
    Publishing country England
    Document type Journal Article
    ZDB-ID 806736-3
    ISSN 1099-1166 ; 0885-6230
    ISSN (online) 1099-1166
    ISSN 0885-6230
    DOI 10.1002/gps.4374
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  8. Article ; Online: Association of Pseudobulbar Affect symptoms with quality of life and healthcare costs in Veterans with traumatic brain injury.

    Rudolph, James L / Fonda, Jennifer R / Hunt, Phillip R / McGlinchey, Regina E / Milberg, William P / Reynolds, Matthew W / Yonan, Charles

    Journal of affective disorders

    2016  Volume 190, Page(s) 150–155

    Language English
    Publishing date 2016-01-15
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 135449-8
    ISSN 1573-2517 ; 0165-0327
    ISSN (online) 1573-2517
    ISSN 0165-0327
    DOI 10.1016/j.jad.2015.10.003
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    Zs.A 1485: Show issues Location:
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  9. Article ; Online: Identification of pseudobulbar affect symptoms in Veterans with possible traumatic brain injury.

    Fonda, Jennifer R / Hunt, Phillip R / McGlinchey, Regina E / Rudolph, James L / Milberg, William P / Reynolds, Matthew W / Yonan, Charles

    Journal of rehabilitation research and development

    2015  Volume 52, Issue 7, Page(s) 839–849

    Abstract: Pseudobulbar affect (PBA), a neurological syndrome characterized primarily by involuntary episodes of laughing and crying, can develop secondary to neurological conditions including traumatic brain injury (TBI). Veterans of the wars in Afghanistan and ... ...

    Abstract Pseudobulbar affect (PBA), a neurological syndrome characterized primarily by involuntary episodes of laughing and crying, can develop secondary to neurological conditions including traumatic brain injury (TBI). Veterans of the wars in Afghanistan and Iraq have an unprecedented risk for TBI, primarily from blast-related munitions. In this cross-sectional study with linkage to Department of Veterans Affairs (VA) clinical data, Veterans screening positive for TBI on the VA TBI screen (N = 4,282) were mailed packets containing two PBA symptom assessments: a single PBA symptom screen question and the Center for Neurologic Study-Lability Scale (CNS-LS) questionnaire. Seventy percent (n = 513) of the 728 Veteran respondents screened positive for PBA symptoms with a CNS-LS score of 13 or greater. There was strong concordance between PBA symptom prevalence measured with the single screening question and CNS-LS, with high sensitivity (0.87) and positive predictive value (0.93), and moderate specificity (0.79). Posttraumatic stress disorder (54% vs 32%), major depression (35% vs 22%), and anxiety disorder (20% vs 13%) were more common for Veterans with PBA symptoms than for those without. PBA symptoms were common in this Veteran cohort, were detected using simple screening tools, and often co-occurred with other psychiatric disorders common in Veterans.
    MeSH term(s) Brain Injuries/complications ; Brain Injuries/diagnosis ; Brain Injuries/epidemiology ; Cross-Sectional Studies ; Depressive Disorder, Major/diagnosis ; Depressive Disorder, Major/epidemiology ; Depressive Disorder, Major/etiology ; Female ; Humans ; Male ; Prevalence ; Retrospective Studies ; United States/epidemiology ; Veterans/psychology
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 605796-2
    ISSN 1938-1352 ; 0007-506X ; 0748-7711 ; 0742-3241 ; 0898-2732
    ISSN (online) 1938-1352
    ISSN 0007-506X ; 0748-7711 ; 0742-3241 ; 0898-2732
    DOI 10.1682/JRRD.2014.08.0191
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    Zs.A 553: Show issues Location:
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  10. Article: An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results.

    Doody, Rachelle S / D'Amico, Stephen / Cutler, Andrew J / Davis, Charles S / Shin, Paul / Ledon, Fred / Yonan, Charles / Siffert, João

    CNS spectrums

    2015  Volume 21, Issue 6, Page(s) 450–459

    Abstract: Background: Dextromethorphan (DM)/quinidine (Q) is an approved treatment for pseudobulbar affect (PBA) based on trials in amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness and tolerability for PBA secondary to ... ...

    Abstract Background: Dextromethorphan (DM)/quinidine (Q) is an approved treatment for pseudobulbar affect (PBA) based on trials in amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness and tolerability for PBA secondary to dementia, stroke, or traumatic brain injury; dementia cohort results are reported.
    Methods: This was an open-label, multicenter, 90 day trial; patients received DM/Q 20/10 mg twice daily. Primary outcome was change in Center for Neurologic Study-Lability Scale (CNS-LS) score. Secondary outcomes included PBA episode count and Clinical and Patient/Caregiver Global Impression of Change scores with respect to PBA (CGI-C/PGI-C).
    Results: 134 patients were treated. CNS-LS improved by a mean (SD) of 7.2 (6.0) points at Day 90/Endpoint (P<.001) vs. baseline. PBA episodes were reduced 67.7% (P<.001) vs. baseline; global measures showed 77.5% CGI-C and 76.5% PGI-C "much"/"very much" improved. Adverse events included headache (7.5%), urinary tract infection (4.5%), and diarrhea (3.7%); few patients dropped out for adverse events (10.4%).
    Conclusions: DM/Q significantly reduced PBA symptoms in patients with dementia; reported adverse events were consistent with the known safety profile of DM/Q. Trial Registration clinicaltrials.gov identifier: NCT01799941.
    MeSH term(s) Aged ; Aged, 80 and over ; Alzheimer Disease/complications ; Dementia/complications ; Dementia, Vascular/complications ; Dextromethorphan/therapeutic use ; Diarrhea/chemically induced ; Drug Combinations ; Excitatory Amino Acid Antagonists/therapeutic use ; Female ; Frontotemporal Dementia/complications ; Headache/chemically induced ; Humans ; Lewy Body Disease/complications ; Male ; Middle Aged ; Pseudobulbar Palsy/drug therapy ; Pseudobulbar Palsy/etiology ; Quinidine/therapeutic use ; Urinary Tract Infections/chemically induced
    Chemical Substances Drug Combinations ; Excitatory Amino Acid Antagonists ; dextromethorphan - quinidine combination ; Dextromethorphan (7355X3ROTS) ; Quinidine (ITX08688JL)
    Language English
    Publishing date 2015-10-16
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2008418-3
    ISSN 2165-6509 ; 1092-8529
    ISSN (online) 2165-6509
    ISSN 1092-8529
    DOI 10.1017/S1092852915000620
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