Objective: Extended-release methylphenidate (ER-MPH) formulations used to treat attention deficit hyperactivity disorder (ADHD) have complex pharmacokinetic (PK) profiles, resulting from differing ratios of immediate-release and extended-release components and/or their site of absorption. This study aimed to evaluate the smoothness of PK curves of ER-MPHs.
Design: The integral of the second derivative squared was evaluated for modeled PK curves, with smaller values indicating a smoother curve. The calculated smoothness of each PK curve was normalized by dividing by Cmax 2 to derive a normalized smoothness parameter appropriate across the dose range of each formulation. Calculations used modeled PK curves from 100mg delayed-release and ER-MPH (DR/ER-MPH), 54mg osmotic release oral system MPH (OROS MPH), 60mg MPH controlled-release delivery (MPH CD), 60mg ER-MPH oral suspension (MEROS), 20mg ER dexmethylphenidate (d-MPH ER), and 60mg multilayer-release MPH (MLR-MPH).
Results: The Cmax2-normalized smoothness value was consistent across DR/ER-MPH doses, allowing for relevant comparisons across formulations. Normalized smoothness values differed widely; the lowest normalized smoothness was 0.05 with DR/ER-MPH and ranged up to 9.56 with d-MPH ER.
Conclusion: DR/ER-MPH demonstrated a smoother PK profile compared to the highest dose of other ER-MPH formulations. While the benefits of a smooth PK profile remain to be tested clinically, having fewer peaks and troughs has been hypothesized to reduce waxing and waning of therapeutic effects throughout the day, and more gradual changes in MPH plasma levels have been hypothesized to lower the risk of likeability and potentially abate afternoon symptom rebound.
{"title":"Quantitative Characterization of the Smoothness of Extended-release Methylphenidate Pharmacokinetic Profiles.","authors":"Michelle D Po, Roberto Gomeni, Bev Incledon","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>Extended-release methylphenidate (ER-MPH) formulations used to treat attention deficit hyperactivity disorder (ADHD) have complex pharmacokinetic (PK) profiles, resulting from differing ratios of immediate-release and extended-release components and/or their site of absorption. This study aimed to evaluate the smoothness of PK curves of ER-MPHs.</p><p><strong>Design: </strong>The integral of the second derivative squared was evaluated for modeled PK curves, with smaller values indicating a smoother curve. The calculated smoothness of each PK curve was normalized by dividing by Cmax 2 to derive a normalized smoothness parameter appropriate across the dose range of each formulation. Calculations used modeled PK curves from 100mg delayed-release and ER-MPH (DR/ER-MPH), 54mg osmotic release oral system MPH (OROS MPH), 60mg MPH controlled-release delivery (MPH CD), 60mg ER-MPH oral suspension (MEROS), 20mg ER dexmethylphenidate (d-MPH ER), and 60mg multilayer-release MPH (MLR-MPH).</p><p><strong>Results: </strong>The Cmax2-normalized smoothness value was consistent across DR/ER-MPH doses, allowing for relevant comparisons across formulations. Normalized smoothness values differed widely; the lowest normalized smoothness was 0.05 with DR/ER-MPH and ranged up to 9.56 with d-MPH ER.</p><p><strong>Conclusion: </strong>DR/ER-MPH demonstrated a smoother PK profile compared to the highest dose of other ER-MPH formulations. While the benefits of a smooth PK profile remain to be tested clinically, having fewer peaks and troughs has been hypothesized to reduce waxing and waning of therapeutic effects throughout the day, and more gradual changes in MPH plasma levels have been hypothesized to lower the risk of likeability and potentially abate afternoon symptom rebound.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9507140/pdf/icns_19_7-9_32.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33492870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Peta Stapleton, Dawson Church, Oliver Baumann, Debbie Sabot
Background: The tendency of the mind to wander, a characteristic of the brain's default mode network (DMN), correlates with increased unhappiness and self-referential processing and is a deterrent to establishing a consistent meditation practice. The objective of this study was to test the impact of a secular physiological method of meditation. We hypothesized that EcoMeditation would produce increases in neural communication in brain regions associated with compassion and prosociality and decreases in self-referencing networks, such as the DMN, and that these changes would be found in the experimental group, but not the control group.
Methods: Participants (n=38) were randomized into two groups, and the final sample consisted of 25 participants. One group listened daily to a 22-minute EcoMeditation audio track, while the other used an active control. Functional magnetic resonance imaging (fMRI) was used to assess brain function before and after four weeks of practice. Mystical experiences, as well as psychological conditions, such as anxiety and depression, were measured.
Results: Participants in the EcoMeditation group showed significantly increased connectivity between the bilateral hippocampus and the bilateral insula, compared to pre-intervention. In addition, significant decreases of connectivity between the bilateral hippocampus and the midprefrontal and left dorsolateral prefrontal cortices occurred. EcoMeditation participants also scored significantly higher for mystical experiences than the control group. The results for emotional states were mixed, with one assessment finding increased positive mood, but another finding increased negative affect.
Conclusion: After only four weeks, participants using EcoMeditation demonstrated brain states similar to meditation adepts with thousands of hours of traditional practice.
{"title":"EcoMeditation Modifies Brain Resting State Network Activity.","authors":"Peta Stapleton, Dawson Church, Oliver Baumann, Debbie Sabot","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>The tendency of the mind to wander, a characteristic of the brain's default mode network (DMN), correlates with increased unhappiness and self-referential processing and is a deterrent to establishing a consistent meditation practice. The objective of this study was to test the impact of a secular physiological method of meditation. We hypothesized that EcoMeditation would produce increases in neural communication in brain regions associated with compassion and prosociality and decreases in self-referencing networks, such as the DMN, and that these changes would be found in the experimental group, but not the control group.</p><p><strong>Methods: </strong>Participants (n=38) were randomized into two groups, and the final sample consisted of 25 participants. One group listened daily to a 22-minute EcoMeditation audio track, while the other used an active control. Functional magnetic resonance imaging (fMRI) was used to assess brain function before and after four weeks of practice. Mystical experiences, as well as psychological conditions, such as anxiety and depression, were measured.</p><p><strong>Results: </strong>Participants in the EcoMeditation group showed significantly increased connectivity between the bilateral hippocampus and the bilateral insula, compared to pre-intervention. In addition, significant decreases of connectivity between the bilateral hippocampus and the midprefrontal and left dorsolateral prefrontal cortices occurred. EcoMeditation participants also scored significantly higher for mystical experiences than the control group. The results for emotional states were mixed, with one assessment finding increased positive mood, but another finding increased negative affect.</p><p><strong>Conclusion: </strong>After only four weeks, participants using EcoMeditation demonstrated brain states similar to meditation adepts with thousands of hours of traditional practice.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9507148/pdf/icns_19_7-9_61.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33492009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS (www.prms.com), a manager of medical professional liability insurance programs with services that include risk management consultation and other resources offered to health care providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers might provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other health care professionals so "clinician" is used to indicate all treatment team members.
{"title":"RISK MANAGEMENT: On the Record: Documentation of Psychiatric Treatment.","authors":"Ann L McNary","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS (www.prms.com), a manager of medical professional liability insurance programs with services that include risk management consultation and other resources offered to health care providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers might provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other health care professionals so \"clinician\" is used to indicate all treatment team members.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9507141/pdf/icns_19_7-9_77.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33492008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kelly Mesa-Gamarra, Mario Pineda-Paternina, Edgar Castillo, Loida Camargo, Alexander Pabón, Jorge Herrera-Pino, Nicole Caldichoury, Pascual A Gargiulo, Yuliana Flórez, Norman López
Introduction: Recent reports have shown several cases of cerebrovascular events after vaccination against COVID-19. The effects have been described mainly in women within the first two weeks of receiving the vaccine.
Clinical case: We describe here the first Colombian case of a cerebrovascular event after vaccination against COVID-19 in a 67-year-old woman with a vascular history. Four days after application of the messenger ribonucleic acid (mRNA) vaccine, she exhibited deviation of the labial commissure, ipsilateral ptosis, and limitation of march with lateralization. The event was associated with a subacute ischemic event in the right thalamus in parasagittal situation, changes in chronic ischemic microangiopathy of small vessels, and vascular crossing in the right cerebellar angle, without other alternative causes.
Conclusion: The development and rapid use of vaccines has allowed the hospitalization and mortality statistics associated with COVID-19 to be reduced, but at the same time, it has generated concern about the potential side effects, generating controversy among the general population, especially in individuals with cardiovascular diseases. In our case, we provided evidence for the discussion of potential cerebrovascular events related to the application of vaccines in older people with a history of cerebrovascular diseases. This was done in order to analyze and control in subsequent studies the modulation of medical history on the likely effects of vaccination. However, despite the unavoidable side effects, the benefits of vaccination are superior.
{"title":"Acute Thalamic Ischemic Stroke in an Older Patient Newly Vaccinated with COVID-19 Vaccine Based on Adenoviral Vectors.","authors":"Kelly Mesa-Gamarra, Mario Pineda-Paternina, Edgar Castillo, Loida Camargo, Alexander Pabón, Jorge Herrera-Pino, Nicole Caldichoury, Pascual A Gargiulo, Yuliana Flórez, Norman López","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>Recent reports have shown several cases of cerebrovascular events after vaccination against COVID-19. The effects have been described mainly in women within the first two weeks of receiving the vaccine.</p><p><strong>Clinical case: </strong>We describe here the first Colombian case of a cerebrovascular event after vaccination against COVID-19 in a 67-year-old woman with a vascular history. Four days after application of the messenger ribonucleic acid (mRNA) vaccine, she exhibited deviation of the labial commissure, ipsilateral ptosis, and limitation of march with lateralization. The event was associated with a subacute ischemic event in the right thalamus in parasagittal situation, changes in chronic ischemic microangiopathy of small vessels, and vascular crossing in the right cerebellar angle, without other alternative causes.</p><p><strong>Conclusion: </strong>The development and rapid use of vaccines has allowed the hospitalization and mortality statistics associated with COVID-19 to be reduced, but at the same time, it has generated concern about the potential side effects, generating controversy among the general population, especially in individuals with cardiovascular diseases. In our case, we provided evidence for the discussion of potential cerebrovascular events related to the application of vaccines in older people with a history of cerebrovascular diseases. This was done in order to analyze and control in subsequent studies the modulation of medical history on the likely effects of vaccination. However, despite the unavoidable side effects, the benefits of vaccination are superior.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341316/pdf/icns_19_4-6_48.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40608163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Innovative Rehabilitation Technologies in the COVID-19 Era: Two Sides of the Same Coin.","authors":"Rocco Salvatore Calabrò, Nicola Fiorente","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341311/pdf/icns_19_4-6_8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40623601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual, plus (LGBTQIA+ or LGBTQ+) individuals face a wide array of health disparities both within and separate from the healthcare system. Transgender patients are subject to microaggressions, misgendering, and harassment from providers, medical staff, and fellow patients. These patients experience drastic disparities in suicidality, depression, anxiety, substance use, malignancy, sexually transmitted disease (STD), and victimization of violence. Providers have the opportunity to intervene and positively impact patient experiences through gender-affirming care, but they first require an adequate knowledge base and understanding of the importance of sensitive and inclusive care. Seemingly small interventions, such as listing one's own pronouns, using gender-neutral language, validating and affirming patients, and utilizing appropriate mental and physical health screenings, can lead to significant impacts on the patient experience, health outcomes, and quality of life. This article will discuss some of the most common disparities and obstacles faced by transgender patients and will argue the paramount role of the provider in establishing gender-affirming care and some high-impact avenues which the provider, regardless of specialty, may pursue when caring for these patients.
{"title":"Gender-affirming Care for Transgender Patients.","authors":"Nita Bhatt, Jesse Cannella, Julie P Gentile","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual, plus (LGBTQIA+ or LGBTQ+) individuals face a wide array of health disparities both within and separate from the healthcare system. Transgender patients are subject to microaggressions, misgendering, and harassment from providers, medical staff, and fellow patients. These patients experience drastic disparities in suicidality, depression, anxiety, substance use, malignancy, sexually transmitted disease (STD), and victimization of violence. Providers have the opportunity to intervene and positively impact patient experiences through gender-affirming care, but they first require an adequate knowledge base and understanding of the importance of sensitive and inclusive care. Seemingly small interventions, such as listing one's own pronouns, using gender-neutral language, validating and affirming patients, and utilizing appropriate mental and physical health screenings, can lead to significant impacts on the patient experience, health outcomes, and quality of life. This article will discuss some of the most common disparities and obstacles faced by transgender patients and will argue the paramount role of the provider in establishing gender-affirming care and some high-impact avenues which the provider, regardless of specialty, may pursue when caring for these patients.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341318/pdf/icns_19_4-6_23.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40623602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Lurasidone is a second-generation antipsychotic (SGA) that contributes an antipsychotic and antidepressant effect, with low incidences of metabolic-related diseases and hyperprolactinemia for the treatment of psychological disorders. However, evidence on lurasidone is limited in psychiatric clinical settings. This study aimed to investigate the effect of short-term lurasidone treatment on metabolic effects and prolactin (PRL) levels, in relation to the differences of psychiatric disorders, lurasidone dosages, and introducing methods, in 35 female and 12 male Japanese inpatients with psychiatric disorders.
Methods: Subjects were placed into six subgroups divided by three categories (schizophrenia/schizoaffective disorder or bipolar disorder, 20mg/day or 40mg/day, adding or switching). Sequential changes in 10 items of metabolic parameters, including estimated insulin resistance and PRL levels at one month, were evaluated. The variations of metabolic parameters that were significantly changed from baseline were analyzed against sample characteristics and other metabolic parameter variations.
Results: In the 40mg/day and switching introduction method groups, lurasidone significantly reduced body weight, body mass index (BMI), levels of alanine amiotransaminase, and levels of fasting blood glucose. PRL levels seemed to increase when lurasidone was added and decrease when lurasidone was switched to from other antipsychotics. Switching introduction method and higher dosage correlated with weight loss and lowering fasting blood glucose levels, respectively.
Conclusion: Lurasidone administration offered the potential for weight loss, lowered serum blood glucose levels, and converging serum PRL concentrations. Moreover, switching introduction method with higher dosages might alleviate basal metabolism and glucose homeostasis. Further prospective studies combining measurements of serum insulin and psychometric evaluation will help to confirm our conclusions.
{"title":"Impact of Lurasidone on Metabolic Parameters and Prolactin Levels Based on Differences of Psychiatric Diagnosis, Dosage, and Introducing Methods: An Observational Study.","authors":"Masaru Nakamura, Takahiko Nagamine","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>Lurasidone is a second-generation antipsychotic (SGA) that contributes an antipsychotic and antidepressant effect, with low incidences of metabolic-related diseases and hyperprolactinemia for the treatment of psychological disorders. However, evidence on lurasidone is limited in psychiatric clinical settings. This study aimed to investigate the effect of short-term lurasidone treatment on metabolic effects and prolactin (PRL) levels, in relation to the differences of psychiatric disorders, lurasidone dosages, and introducing methods, in 35 female and 12 male Japanese inpatients with psychiatric disorders.</p><p><strong>Methods: </strong>Subjects were placed into six subgroups divided by three categories (schizophrenia/schizoaffective disorder or bipolar disorder, 20mg/day or 40mg/day, adding or switching). Sequential changes in 10 items of metabolic parameters, including estimated insulin resistance and PRL levels at one month, were evaluated. The variations of metabolic parameters that were significantly changed from baseline were analyzed against sample characteristics and other metabolic parameter variations.</p><p><strong>Results: </strong>In the 40mg/day and switching introduction method groups, lurasidone significantly reduced body weight, body mass index (BMI), levels of alanine amiotransaminase, and levels of fasting blood glucose. PRL levels seemed to increase when lurasidone was added and decrease when lurasidone was switched to from other antipsychotics. Switching introduction method and higher dosage correlated with weight loss and lowering fasting blood glucose levels, respectively.</p><p><strong>Conclusion: </strong>Lurasidone administration offered the potential for weight loss, lowered serum blood glucose levels, and converging serum PRL concentrations. Moreover, switching introduction method with higher dosages might alleviate basal metabolism and glucose homeostasis. Further prospective studies combining measurements of serum insulin and psychometric evaluation will help to confirm our conclusions.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341320/pdf/icns_19_4-6_70.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40623607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Neuromyelitis optica spectrum disorder (NMOSD) is a neurological condition consisting of relapse-related disability. Treatment options are limited. This systematic review and meta-analysis aimed to evaluate the effectiveness and tolerability of rituximab (RTX) in comparison to azathioprine (AZT) and mycophenolate mofetil (MMF) for the treatment of NMOSD.
Methods: A systematic search was conducted among electronic databases, including PubMed, Scopus, EBSCO, and Cochrane, for relevant studies. We included randomized, controlled trials and prospective and retrospective studies evaluating the efficacy and safety of RTX compared to AZT and/or MMF in adult and pediatric patients with NMOSD. The Newcastle-Ottawa Scale (NOS) and Cochrane Collaboration tool were used to determine the risk of bias.
Results: Eleven studies involving 1,086 patients were included in our study. Treatment with RTX generally yielded favorable annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) results in comparison to AZT and MMF, despite its variable statistical significance. RTX treatment reduced the relapse rate and hazard risk for relapse (HRR). Patients in the RTX group experienced significantly fewer adverse events, among which the most common were allergies, infections, and leukopenia.
Conclusion: In this study, RTX appeared to be superior to AZT and MMF in improving disability and reducing relapse in patients with NMOSD. RTX is also associated with fewer adverse events based on pooled analysis. Future randomized clinical trials are needed to establish the efficacy and safety of RTX in patients with NMOSD.
{"title":"Comparative Analysis of Treatment Outcomes in Patients with Neuromyelitis Optica Spectrum Disorder Treated with Rituximab, Azathioprine, and Mycophenolate Mofetil: A Systematic Review and Meta-analysis.","authors":"Christy Magdalena, Audrey Clarissa, Nathania Sutandi","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>Neuromyelitis optica spectrum disorder (NMOSD) is a neurological condition consisting of relapse-related disability. Treatment options are limited. This systematic review and meta-analysis aimed to evaluate the effectiveness and tolerability of rituximab (RTX) in comparison to azathioprine (AZT) and mycophenolate mofetil (MMF) for the treatment of NMOSD.</p><p><strong>Methods: </strong>A systematic search was conducted among electronic databases, including PubMed, Scopus, EBSCO, and Cochrane, for relevant studies. We included randomized, controlled trials and prospective and retrospective studies evaluating the efficacy and safety of RTX compared to AZT and/or MMF in adult and pediatric patients with NMOSD. The Newcastle-Ottawa Scale (NOS) and Cochrane Collaboration tool were used to determine the risk of bias.</p><p><strong>Results: </strong>Eleven studies involving 1,086 patients were included in our study. Treatment with RTX generally yielded favorable annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) results in comparison to AZT and MMF, despite its variable statistical significance. RTX treatment reduced the relapse rate and hazard risk for relapse (HRR). Patients in the RTX group experienced significantly fewer adverse events, among which the most common were allergies, infections, and leukopenia.</p><p><strong>Conclusion: </strong>In this study, RTX appeared to be superior to AZT and MMF in improving disability and reducing relapse in patients with NMOSD. RTX is also associated with fewer adverse events based on pooled analysis. Future randomized clinical trials are needed to establish the efficacy and safety of RTX in patients with NMOSD.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341317/pdf/icns_19_4-6_51.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40623606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Georgia Mitsi, Todd Grinnell, Suzanne Giordano, Thomas Goodin, Shahin Sanjar, Elizabeth Marble, Andrei Pikalov
Multiple digital health technologies have been evaluated across clinical development programs, including external, wearable, implantable, and ingestible devices and sensors, along with digital mobile health applications (apps) that are accessible via users' personal electronic devices (e.g., smartphones, tablets, and computers). Several of these technologies have been incorporated into our ongoing neurology and respiratory clinical development programs. Based on our experience, one of the greatest potential benefits of digital health technologies is the ability to collect objective and/or biological data continuously or at regular intervals outside of office visits during a patient's normal daily activities to provide additional efficacy and safety information, versus data capture from traditional episodic, time point-based office visits. Many challenges encountered with digital health technologies can be successfully addressed by providing the appropriate training to staff and patients, ensuring availability of appropriate infrastructure support, and conducting pilot studies before scaling up to larger trials. Overall, our experience with digital health technologies demonstrated their potential to increase the amount of objective data collected in clinical trials, expand patient access to trials, and facilitate further improvement of clinical outcomes.
{"title":"Implementing Digital Technologies in Clinical Trials: Lessons Learned.","authors":"Georgia Mitsi, Todd Grinnell, Suzanne Giordano, Thomas Goodin, Shahin Sanjar, Elizabeth Marble, Andrei Pikalov","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Multiple digital health technologies have been evaluated across clinical development programs, including external, wearable, implantable, and ingestible devices and sensors, along with digital mobile health applications (apps) that are accessible via users' personal electronic devices (e.g., smartphones, tablets, and computers). Several of these technologies have been incorporated into our ongoing neurology and respiratory clinical development programs. Based on our experience, one of the greatest potential benefits of digital health technologies is the ability to collect objective and/or biological data continuously or at regular intervals outside of office visits during a patient's normal daily activities to provide additional efficacy and safety information, versus data capture from traditional episodic, time point-based office visits. Many challenges encountered with digital health technologies can be successfully addressed by providing the appropriate training to staff and patients, ensuring availability of appropriate infrastructure support, and conducting pilot studies before scaling up to larger trials. Overall, our experience with digital health technologies demonstrated their potential to increase the amount of objective data collected in clinical trials, expand patient access to trials, and facilitate further improvement of clinical outcomes.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341314/pdf/icns_19_4-6_65.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40623603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Takayuki Suga, Takahiko Nagamine, Trang T H Tu, Keiji Moriyama, Akira Toyofuku
{"title":"Orthognathic Surgery for Patients with Neurodevelopmental Disorders Requires Careful Decision-making by a Multidisciplinary Team.","authors":"Takayuki Suga, Takahiko Nagamine, Trang T H Tu, Keiji Moriyama, Akira Toyofuku","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341309/pdf/icns_19_4-6_9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40608159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}