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The Rapid Mood Screener: A Novel and Pragmatic Screener Tool for Bipolar I Disorder
- C. Brendan Montano, Mehul Patel, Rakesh Jain, Prakash S. Masand, Amanda Harrington, Patrick Gillard, Kate Sullivan, Susan L. McElroy, T. Michelle Brown, Lauren Nelson, Roger S. McIntyre
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- Journal:
- CNS Spectrums / Volume 26 / Issue 2 / April 2021
- Published online by Cambridge University Press:
- 10 May 2021, pp. 167-168
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Introduction
Approximately 70% of patients with bipolar disorder (BPD) are initially misdiagnosed, resulting in significantly delayed diagnosis of 7–10 years on average. Misdiagnosis and diagnostic delay adversely affect health outcomes and lead to the use of inappropriate treatments. As depressive episodes and symptoms are the predominant symptom presentation in BPD, misdiagnosis as major depressive disorder (MDD) is common. Self-rated screening instruments for BPD exist but their length and reliance on past manic symptoms are barriers to implementation, especially in primary care settings where many of these patients initially present. We developed a brief, pragmatic bipolar I disorder (BPD-I) screening tool that not only screens for manic symptoms but also includes risk factors for BPD-I (eg, age of depression onset) to help clinicians reduce the misdiagnosis of BPD-I as MDD.
MethodsExisting questionnaires and risk factors were identified through a targeted literature search; a multidisciplinary panel of experts participated in 2 modified Delphi panels to select concepts thought to differentiate BPD-I from MDD. Individuals with self-reported BPD-I or MDD participated in cognitive debriefing interviews (N=12) to test and refine item wording. A multisite, cross-sectional, observational study was conducted to evaluate the screening tool’s predictive validity. Participants with clinical interview-confirmed diagnoses of BPD-I or MDD completed a draft 10-item screening tool and additional questionnaires/questions. Different combinations of item sets with various item permutations (eg, number of depressive episodes, age of onset) were simultaneously tested. The final combination of items and thresholds was selected based on multiple considerations including clinical validity, optimization of sensitivity and specificity, and pragmatism.
ResultsA total of 160 clinical interviews were conducted; 139 patients had clinical interview-confirmed BPD-I (n=67) or MDD (n=72). The screening tool was reduced from 10 to 6 items based on item-level analysis. When 4 items or more were endorsed (yes) in this analysis sample, the sensitivity of this tool for identifying patients with BPD-I was 0.88 and specificity was 0.80; positive and negative predictive values were 0.80 and 0.88, respectively. These properties represent an improvement over the Mood Disorder Questionnaire, while using >50% fewer items.
ConclusionThis new 6-item BPD-I screening tool serves to differentiate BPD-I from MDD in patients with depressive symptoms. Use of this tool can provide real-world guidance to primary care practitioners on whether more comprehensive assessment for BPD-I is warranted. Use of a brief and valid tool provides an opportunity to reduce misdiagnosis, improve treatment selection, and enhance health outcomes in busy clinical practices.
FundingAbbVie Inc.
156 The Broad Efficacy of Cariprazine Across Symptoms in Patients with Bipolar I Disorder: Post Hoc Analysis of Randomized, Placebo-Controlled Trials
- Lakshmi N. Yatham, Eduard Vieta, Roger S. McIntyre, Rakesh Jain, Willie R. Earley, Mehul Patel
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- Journal:
- CNS Spectrums / Volume 25 / Issue 2 / April 2020
- Published online by Cambridge University Press:
- 24 April 2020, p. 300
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Study Objective:
Patients with bipolar disorder experience a wide range of depressive and manic symptoms. Only 2 drugs are FDA-approved to treat episodes of both mania and depression in patients with bipolar disorder, highlighting the need for treatments with proven efficacy at opposite poles of the bipolar spectrum. Cariprazine, a dopamine D3-preferring D3/D2 receptor partial agonist and serotonin 5-HT1A receptor partial agonist, is approved in the US for the treatment of both bipolar depression and manic and mixed episodes associated with bipolar I disorder. Cariprazine has previously demonstrated broad efficacy in patients with bipolar mania, with significantly greater improvement in favor of cariprazine vs placebo (PBO) across all individual symptom domains (P<.001) measured by the Young Mania Rating Scale (YMRS). Additionally, cariprazine has demonstrated efficacy vs PBO in 3 phase II/III clinical studies in patients with depressive episodes associated with bipolar I disorder (NCT01396447, NCT02670538, NCT02670551). To further assess the broad efficacy of cariprazine in patients with bipolar I disorder, we performed post hoc analyses to evaluate the range of depressive symptoms comprising the individual items of the Montgomery-Åsberg Depression Rating Scale (MADRS) in patients from the bipolar depression studies.
Methods:Data from the 3 randomized, double-blind, PBO-controlled trials in patients with bipolar depression were pooled. Least squares (LS) mean change from baseline to week 6 in MADRS individual items was assessed in the pooled cariprazine 1.5 and 3 mg/d groups vs PBO using a mixed-effects model for repeated measures in the intent-to-treat (ITT) population.
Results:There were 1383 patients in the ITT population (placebo=460; cariprazine 1.5-3 mg/d=923). At week 6, LS mean change from baseline was significantly greater for cariprazine 1.5-3 mg/d vs PBO on 9 of 10 individual MADRS items: Apparent Sadness (-2.0 vs -1.6, P<.0001); Reported Sadness (-2.0 vs -1.6, P<.0001); Reduced Sleep (-1.6 vs -1.4, P=.0357); Reduced Appetite (-1.2 vs -1.0, P=.0001); Concentration Difficulties (-1.5 vs -1.2, P=.0002); Lassitude (-1.7 vs -1.4, P=.0003); Inability To Feel (-1.7 vs -1.5, P=.0009); Pessimistic Thoughts (-1.4 vs -1.2, P=.0054) and Suicidal Thoughts (-0.3 vs -0.2, P=.0383); differences between cariprazine and PBO on the Inner Tension item were not significant.
Conclusions:Significant improvement in most MADRS single items suggests broad efficacy in depressive symptoms for cariprazine 1.5-3 mg/d vs PBO in patients with bipolar depression. Coupled with broad efficacy in manic symptoms as demonstrated by significant improvement in all YMRS individual items in patients with bipolar mania or mixed episodes, cariprazine appears be effective across the range of symptoms that affect patients with bipolar disorder.
Funding Acknowledgements:Supported by Allergan plc.
Systematic evaluation of the QualityRights programme in public mental health facilities in Gujarat, India
- Soumitra Pathare, Michelle Funk, Natalie Drew Bold, Ajay Chauhan, Jasmine Kalha, Sadhvi Krishnamoorthy, Jaime C. Sapag, Sireesha J. Bobbili, Rama Kawade, Sandeep Shah, Ritambhara Mehta, Animesh Patel, Upendra Gandhi, Mahesh Tilwani, Rakesh Shah, Hitesh Sheth, Ganpat Vankar, Minakshi Parikh, Indravadan Parikh, Thara Rangaswamy, Amritkumar Bakshy, Akwatu Khenti
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- Journal:
- The British Journal of Psychiatry / Volume 218 / Issue 4 / April 2021
- Published online by Cambridge University Press:
- 20 June 2019, pp. 196-203
- Print publication:
- April 2021
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Background
Recognising the significant extent of poor-quality care and human rights issues in mental health, the World Health Organization launched the QualityRights initiative in 2013 as a practical tool for implementing human rights standards including the United Nations Convention on Rights of Persons with Disabilities (CRPD) at the ground level.
AimsTo describe the first large-scale implementation and evaluation of QualityRights as a scalable human rights-based approach in public mental health services in Gujarat, India.
MethodThis is a pragmatic trial involving implementation of QualityRights at six public mental health services chosen by the Government of Gujarat. For comparison, we identified three other public mental health services in Gujarat that did not receive the QualityRights intervention.
ResultsOver a 12-month period, the quality of services provided by those services receiving the QualityRights intervention improved significantly. Staff in these services showed substantially improved attitudes towards service users (effect sizes 0.50–0.17), and service users reported feeling significantly more empowered (effect size 0.07) and satisfied with the services offered (effect size 0.09). Caregivers at the intervention services also reported a moderately reduced burden of care (effect size 0.15).
ConclusionsTo date, some countries are hesitant to reforming mental health services in line with the CRPD, which is partially attributable to a lack of knowledge and understanding about how this can be achieved. This evaluation shows that QualityRights can be effectively implemented even in resource-constrained settings and has a significant impact on the quality of mental health services.
The safety of ethanol infusions for the treatment of methanol or ethylene glycol intoxication: an observational study
- Mary Kate Wedge, Sabrina Natarajan, Christel Johanson, Rakesh Patel, Salmaan Kanji
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- Journal:
- Canadian Journal of Emergency Medicine / Volume 14 / Issue 5 / September 2012
- Published online by Cambridge University Press:
- 11 May 2015, pp. 283-289
- Print publication:
- September 2012
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Background:
Methanol or ethylene glycol ingestion may result in significant morbidity or death without prompt treatment. Despite traditional and widespread use of intravenous ethanol as an antidote, its safety is not well described. An evaluation of the safety and ease of titrating ethanol infusions is necessary given the availability of an alternative antidote.
Objective:To evaluate the safety and ease of titrating ethanol infusions for the treatment of methanol or ethylene glycol ingestion.
Methods:We reviewed the hospital records of adults treated with ethanol at The Ottawa Hospital for methanol or ethylene glycol ingestion over a 9-year period. Using a standardized case report form, a single reviewer identified prespecified adverse events that developed after the start of ethanol therapy and classified dose adjustments during ethanol therapy as appropriate or inappropriate based on a priori criteria.
Results:Forty-nine cases of methanol or ethylene glycol ingestion treated with ethanol were included in the analysis, of which 45 underwent hemodialysis, 38 were admitted to the intensive care unit, and 4 died. At least one adverse event was identified in 45 (92%) cases, including 35 (71%) with agitation requiring chemical or physical restraints and 10 (20%) with a depressed level of consciousness treated with intubation. The median number of ethanol concentration measurements per treatment course was 6 (range 0–24), of which only 27% were within the target range of 22 to 30 mmol/L and 47% were below. When measured concentrations were outside the target, the adjustment in ethanol dosing (or lack thereof) was deemed inappropriate 59% of the time, including 69% of the time during hemodialysis.
Conclusion:Based on actual practice in a large academic centre, adverse events occur frequently with intravenous ethanol infusions, and ethanol titration is inefficient. The safety profile and therapeutic drug monitoring considerations for ethanol should be considered when choosing an antidote for methanol or ethylene glycol ingestion.
Therapeutic benefit of radiotherapy after surgery in patients with T1–T2 breast tumour
- Budhi S. Yadav, Suresh C. Sharma, Firuza D. Patel, S.M. Bose, Sushmita Ghoshal, Rakesh K. Kapoor
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- Journal:
- Journal of Radiotherapy in Practice / Volume 9 / Issue 1 / March 2010
- Published online by Cambridge University Press:
- 25 February 2010, pp. 33-40
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Purpose: To look for the therapeutic benefit of radiotherapy after surgery in patients with T1–T2 breast tumour.
Methodology: From 1990 to 2000, 915 patients with T1–T2 breast tumour who underwent mastectomy or conservative breast surgery (CBS) with or without radiotherapy were analysed retrospectively for age, disease stage, radiation therapy technique, dose, the use of chemotherapy or hormonal therapy and other clinical and/or pathologic characteristics. The Kaplan–Meier method was used to estimate locoregional recurrence-free survival (LRRFS) and overall survival (OS). The Cox proportional hazard regression model was used to determine significant prognostic factors affecting LRRFS and OS.
Results: At a median follow up of 74 months, LRR rate was 5.3% and distant metastases rate was 19%. Disease-free survival (DFS) and OS at 10 year was 72% and 76%, respectively. LRR in patients with CBS followed with radiation was 3% as compared to 33% without radiation. LRR in patients with post-mastectomy radiation was 3% as compared to 19% without radiation. In patients with N0 nodes, LRR was 4% with radiation and 20% without radiation. Worst case was in patients with CBS-N0 who were not given radiation. LRR in such patients was 32% as compared to 5% in those who were given radiation post-CBS. In patients with mastectomy with N0 status, LRR was 3% with radiation as compared to 18% with out radiation. On univariate analysis factors affecting LRRFS were type of surgery, nodal involvement, radiotherapy and hormonal therapy. Factors affecting OS were nodal involvement, grade, lymphovascular invasion (LVI), ductal carcinoma in situ (DCIS), extracapsular extension (ECE), chemotherapy and radiotherapy. On multivariate analysis factors affecting LRRFS were type of surgery, nodal involvement, radiotherapy and hormonal therapy. Factors affecting OS were nodal involvement, LVI, DCIS, ECE, chemotherapy and radiotherapy.
Conclusion: Radiation use offered a therapeutic advantage for all patients with T1–T2 breast cancer.
Influenza Vaccine: Immunization Rates, Knowledge, and Attitudes of Resident Physicians in an Urban Teaching Hospital
- A. Patricia Wodi, Sawsan Samy, Echezona Ezeanolue, Rytza Lamour, Rakesh Patel, Lawrence D. Budnick, Barry Dashefsky
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- Journal:
- Infection Control & Hospital Epidemiology / Volume 26 / Issue 11 / November 2005
- Published online by Cambridge University Press:
- 21 June 2016, pp. 867-873
- Print publication:
- November 2005
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Background:
Because resident physicians (RPs) frequently have direct patient contact, those who are unimmunized against influenza potentially subject patients to unnecessary risk of infection.
Objective:To determine the rates of, knowledge regarding, and attitudes toward influenza immunization among RPs. We hypothesized that rates of and knowledge about influenza immunization did not differ between primary care (PC) and non-PC RPs.
Methods:A self-administered, anonymous questionnaire distributed to a convenience sample of 300 RPs (150 PC and 150 non-PC). The questionnaire requested influenza immunization status in the 2003-2004 and previous seasons and factors influencing respondents' decisions whether to be immunized. It included a 20-item test of knowledge about influenza immunization.
Results:Two hundred five (68.3%) of 300 distributed questionnaires (196 that were evaluable) were returned. Response rates of PC and non-PC RPs did not differ (P = .79). The overall immunization rate of RPs in 2003-2004 was 38.3% and rates did not differ between PC (38.9%) and non-PC (37.6%) RPs. RPs most often cited “self-protection” as a reason for electing (93.3%) and “lack of time” for declining (47.1%) influenza immunization. Their ability to correctly answer questions about influenza immunization varied; their mean knowledge score was 13.7 (perfect = 20). PC and non-PC trainees did not differ by knowledge score (P = .48). However, RPs “ever vaccinated” had a higher knowledge score than those “never vaccinated” (P = .01).
Conclusion:RPs have low immunization rates and significant gaps in knowledge regarding influenza immunization. These problems should be addressed during their training by education on the importance, effectiveness, and safety of influenza vaccine for them and their patients.