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Evidence-based treatments for posttraumatic stress disorder (PTSD), including psychotherapies and medications, have high dropout and nonresponse rates, suggesting that more acceptable and effective treatments for PTSD are needed. Capnometry Guided Respiratory Intervention (CGRI) is a digital therapeutic effective in panic disorder that measures and displays end-tidal carbon dioxide (EtCO2) and respiratory rate (RR) in real-time within a structured breathing protocol and may have benefit in PTSD by moderating breathing and EtCO2 levels. We conducted a single-arm study of a CGRI system, Freespira®, to treat symptoms of PTSD. Participants with PTSD (n = 55) were treated for four weeks with twice-daily, 17-min at-home CGRI sessions using a sensor and tablet with pre-loaded software. PTSD and associated symptoms were assessed at baseline, end-of treatment, 2-months and 6-months post-treatment. Primary efficacy outcome was 50% of participants having ≥ 6-point decrease in Clinician Administered PTSD Scale (CAPS-5) score at 2-month follow up. Tolerability, usability, safety, adherence and patient satisfaction were assessed. CGRI was well tolerated, with 88% [95% CI 74-96%] having ≥ 6-point decrease in CAPS-5 scores at 2-months post-treatment follow up. Mean CAPS-5 scores decreased from 49.5 [s.d. = 9.2] at baseline to 27.1 [s.d. = 17.8] at 2-months post-treatment follow up. Respiratory rate decreased and EtCO2 levels increased. Associated mental and physical health symptoms also improved. This CGRI intervention was safe, acceptable, and well-tolerated in improving symptoms in this study in PTSD. Further study against an appropriate comparator is warranted.Trial registration Clinicaltrials.gov NCT#03039231.
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Transtorno de Pânico , Transtornos de Estresse Pós-Traumáticos , Humanos , Respiração , Taxa Respiratória , Transtornos de Estresse Pós-Traumáticos/terapia , Resultado do TratamentoRESUMO
We are grateful to Professors Rebecca Reuber and Eileen Fischer for contributing our 2022 annual review article. This insightful review explores an issue of great contemporary importance regarding the relationship between entrepreneurial activities and social media platforms. Whilst there is much popular and media commentary regarding the opportunities such platforms offer for entrepreneurship, we lack informed, academic reflection upon the role and influence of such platforms for both good and ill. Hence, this review article is timely in identifying current practices and raising important issues for future research. Our thanks to the authors for their valuable contribution to the ISBJ. Entrepreneurs create digital platforms which, in turn, facilitate entrepreneurial behaviours of others, the platform users. An important start-up activity is developing the mechanisms to govern user participation. While prior literature has provided insights on the governance of innovation platforms and exchange platforms, it has shed little light on the governance of social media platforms. In this review, we synthesize the emerging literature on diverse social media platforms, focussing on four types of governance mechanisms: those that regulate user behaviour, those related to user identification and stature, those that structure relationships among users and those that direct user attention. We highlight the implications of this body of literature for entrepreneurship scholars.
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BACKGROUND: Pharmacotherapies for depression are often ineffective and treatment-resistant depression (TRD) is common across bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). Patient genetic information can be used to predict treatment outcomes. Prospective studies indicate that pharmacogenetic (PGX) tests have utility in the treatment of depression. However, few studies have examined the utility of PGX in other diagnoses typified by depression, or in veterans, a cohort with high rates of medical comorbidity, social stress, and suicide. AIM: To determine the efficacy of genetically guided pharmacological treatment of TRD. METHODS: We conducted an 8-week, prospective, multisite, single-blind study in 182 veterans with TRD including patients with BD, MDD, and PTSD. Subjects were randomly assigned to PGX-guided treatment in which the clinician incorporated PGX information into decision-making, or treatment as usual (TAU). RESULTS: Overall, the PGX group improved marginally faster compared to TAU, but the difference was not statistically significant. Secondary analyses revealed that only PTSD patients showed a potential benefit from PGX testing. Patients predicted by PGX testing to have moderate levels of genetic risk showed a significant benefit from the PGX-guided treatment, whereas other risk groups demonstrated no benefit. Clinicians generally found the PGX test was useful, particularly in more depressed patients and/or those with more warnings for significant or serious adverse outcomes. Clinicians more often used the results to select a drug, but only rarely to adjust dosing. CONCLUSIONS: The data reveal possible group differences in the utility of PGX testing in veterans with TRD.ClinicalTrials.gov Identifier: NCT04469322.
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Transtorno Bipolar/tratamento farmacológico , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Testes Farmacogenômicos/métodos , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antidepressivos/administração & dosagem , Transtorno Bipolar/genética , Estudos de Coortes , Transtorno Depressivo Maior/genética , Transtorno Depressivo Resistente a Tratamento/genética , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacogenética , Estudos Prospectivos , Método Simples-Cego , Transtornos de Estresse Pós-Traumáticos/genética , Resultado do Tratamento , Veteranos , Adulto JovemRESUMO
Importance: To our knowledge, no study has previously evaluated whether individuals with bipolar depression enriched a priori on the basis of biochemical and/or phenotypic immuno-inflammatory activation would differentially respond to an anti-inflammatory agent for the treatment of depressive symptoms. Objective: To assess the antidepressant efficacy of adjunctive infliximab, a monoclonal antibody targeting tumor necrosis factor, in adults with bipolar I and bipolar II depression and inflammatory conditions. Design, Setting, and Participants: This 12-week, randomized, double-blind, placebo-controlled, parallel-group trial of 60 participants was conducted at 2 outpatient tertiary care sites in Canada and the United States. Eligible adults (aged 18-65 years) met DSM-5-defined criteria for bipolar I or bipolar II depression and exhibited pretreatment biochemical and/or phenotypic evidence of inflammatory activation. Participants were enrolled between October 1, 2015, and April 30, 2018. Data analysis was performed from May 1 through July 31, 2018, using modified intent-to-treat analysis. Interventions: Patients were randomized to receive 3 intravenous infusions of infliximab therapy or placebo at baseline and at weeks 2 and 6 of the 12-week study. Main Outcomes and Measures: The primary efficacy outcome was baseline-to-end point (ie, week-12) change in Montgomery-Asberg Depression Rating Scale (MADRS) total score. History of childhood maltreatment, as assessed by the Childhood Trauma Questionnaire, was used for exploratory analyses as 1 of several secondary outcomes. Results: A total of 60 participants were randomized to infliximab (n = 29 [48%]; mean [SD] age, 45.0 [11.7] years; 20 of 28 female [71%]) or to placebo (n = 31 [52%]; mean [SD] age, 46.8 [10.2] years; 26 of 30 female [87%]) across study sites. Overall baseline-to-end point change in MADRS total score was observed across treatment × time interaction (χ2 = 10.33; P = .04); reduction in symptom severity was not significant at week 12 (relative risk, 1.09; 95% CI, 0.80-1.50; df = 1; P = .60). As part of a secondary analysis, a significant treatment × time × childhood maltreatment interaction was observed in which infliximab-treated individuals with childhood history of physical abuse exhibited greater reductions in MADRS total score (χ2 = 12.20; P = .02) and higher response rates (≥50% reduction in MADRS total score) (χ2 = 4.05; P = .04). Conclusions and Relevance: Infliximab did not significantly reduce depressive symptoms compared with placebo in adults with bipolar depression. Results from secondary analyses identified a subpopulation (ie, those reporting physical and/or sexual abuse) that exhibited a significant reduction in depressive symptoms with infliximab treatment compared with placebo. Trial Registration: ClinicalTrials.gov identifier: NCT02363738.
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Antidepressivos/farmacologia , Transtorno Bipolar/tratamento farmacológico , Depressão/tratamento farmacológico , Infliximab/farmacologia , Avaliação de Resultados em Cuidados de Saúde , Adulto , Sobreviventes Adultos de Maus-Tratos Infantis , Antidepressivos/administração & dosagem , Antidepressivos/efeitos adversos , Transtorno Bipolar/complicações , Depressão/etiologia , Método Duplo-Cego , Feminino , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
OBJECTIVE: The effects of viscosity, taste, and nectar-thick liquid bolus volume on swallowing apnea duration (SAD) were examined. STUDY DESIGN AND SETTING: Twenty-two adults, comprised of 10 males and 12 females, participated. SAD was assessed via nasal airflow during swallow conditions of viscosity (thin liquid, thick liquid, and puree), taste (water, apple juice, lemon concentrate), and nectar-thick liquid bolus volumes (5, 10, 15, and 20 mL) across three trials. RESULTS: A significant main effect of nectar-thick liquid bolus volume was found (P < 0.05). Viscosity and taste were not significant. CONCLUSIONS: SAD increased with increases in bolus volume; however, neither changes in bolus viscosity nor changes in taste affected SAD. SIGNIFICANCE: These findings indicate that since viscosity was not significant, the normative data previously published (by this PI) with 60 healthy adults stratified by age and gender can be utilized for comparison to disordered swallowing without regard to the bolus viscosity being used. EBM RATING: D.