scholarly journals Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST – MST): Study Protocol for a Randomized Non-Inferiority Trial of Magnetic Seizure Therapy versus Electroconvulsive Therapy

2021 ◽  
Author(s):  
Zafiris Daskalakis ◽  
Carol Tamminga ◽  
Alanah Throop ◽  
Lucy Palmer ◽  
Julia Dimitrova ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Adverse Effects ◽  
Electroconvulsive Therapy ◽  
High Frequency ◽  
Antidepressant Treatment ◽  
Healthcare Providers ◽  
The United States ◽  
Eligibility Criteria ◽  
Magnetic Seizure Therapy ◽  
Double Blinded

Abstract BackgroundElectroconvulsive therapy (ECT) is well-established and effective for treatment resistant depression (TRD), but in Canada and the United States, less than 1% of patients with TRD receive ECT mainly due to its cognitive adverse effects (i.e., amnesia). Thus, new treatment alternatives for TRD are urgently needed. One such treatment is Magnetic Seizure Therapy (MST). ECT involves applying a train of high frequency electrical stimuli to induce a seizure, whereas MST involves applying a train of high frequency magnetic stimuli to induce a seizure. MethodsIn this manuscript, we introduce our international, two-site, double-blinded, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. This trial will compare the efficacy of MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT) with a combined primary endpoint of remission of depression and superior cognitive adverse effects in 260 patients with TRD. Amelioration of suicidal ideation will be assessed as a secondary endpoint. Inpatients or outpatients, over 18 years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD) can be enrolled in the study provided that they meet illness severity and full eligibility criteria. Participants are randomized to receive MST or RUL-UB ECT, 2-3 days per week over seven weeks, or a maximum of 21 treatments. The study will involve before-, during-, and after-treatment assessments of depression severity, suicidal ideation, subjective side-effects, and cognitive performance consistent with an intent-to-treat study design approach. DiscussionPositive results from this trial could have an immediate and tremendous impact for patients with TRD. If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice. Indeed, given that the administration of MST is nearly identical to ECT, the majority of ECT facilities in North America could readily adopt MST. Furthermore, the potential for cognitive safety could lead to improved treatment acceptability. Healthcare providers, patients and care partners, and policymakers would therefore demand this form of convulsive therapy.Trial RegistrationClinical Trials Gov NCT03191058, Registered June 19, 2017

scholarly journals Gender Differences in the Prevalence of Complementary and Alternative Medicine Utilization among Adults with Arthritis in the United States

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Monira Alwhaibi ◽  
Yazed AlRuthia ◽  
Abdulkarim M. Meraya
Keyword(s):  
Alternative Medicine ◽  
Complementary And Alternative Medicine ◽  
Functional Limitation ◽  
Healthcare Providers ◽  
The United States ◽  
Utilization Rate ◽  
Eligibility Criteria ◽  
The Past ◽  
Cam Use ◽  
Complementary And Alternative

Objective. To examine the association between sex and the use of complementary and alternative medicine (CAM) among adults with arthritis. Methods. Data from the 2012 National Health Interview Survey on CAM use for adults with arthritis were analyzed. Five different multivariable regression models were used to examine the association between sex and CAM use after adjusting for demographics, socioeconomics, perceived health status, functional limitations, comorbid chronic conditions, body mass index, and personal health practices. Results. The number of subjects who met the eligibility criteria and were eventually included in the study was 7,919 adults with arthritis. Around half of the study sample reported ever using CAM (n = 4,055), and about 27% (n = 2,016) reported using CAM in the past 12 months. Women have a significantly higher rate of ever utilization of CAM compared to their male counterparts (62.2% vs. 37.8%) as well as CAM use over the past 12 months (66.1% vs. 33.9%). After controlling for other covariates that can potentially affect the use of CAM, women had higher odds of ever using CAM (AOR = 1.68, 95% CI = 1.55–1.81) as well as the CAM use in the past 12 months (AOR = 1.63, 95% CI = 1.49–1.78) compared to men. Functional limitation and multiple comorbidities were associated with CAM use among women. Conclusions. The utilization rate of CAM among women with arthritis is significantly higher compared to their male counterparts, which highlights the need to screen adults with arthritis, particularly women, for potential drug-CAM interactions. Also, practicing patient-centered care is important, which should allow the patients to discuss the potential benefits and risks of CAM use with their healthcare providers.

scholarly journals Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zafiris J. Daskalakis ◽  
Shawn M. McClintock ◽  
Itay Hadas ◽  
Elisa Kallioniemi ◽  
Reza Zomorrodi ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Adverse Effects ◽  
Resting State ◽  
Cortical Inhibition ◽  
Multiscale Entropy ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Eeg Activity ◽  
Magnetic Seizure Therapy ◽  
Link Type

Abstract Background Electroconvulsive therapy (ECT) is the most effective treatment for treatment-resistant depression (TRD), especially for acute suicidal ideation, but the associated cognitive adverse effects and negative stigma limit its use. Another seizure therapy under development is magnetic seizure therapy (MST), which could potentially overcome the restrictions associated with ECT with similar efficacy. The neurophysiological targets and mechanisms of seizure therapy, however, remain poorly understood. Methods/design This neurophysiological study protocol is published as a companion to the overall Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST) protocol that describes our two-site, double-blind, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. Our aim for the neurophysiological component of the study is to evaluate two biomarkers, one to predict remission of suicidal ideation (primary outcome) and the other to predict cognitive impairment (secondary outcome). Suicidal ideation will be assessed through cortical inhibition, which according to our preliminary studies, correlates with remission of suicidal ideation. Cortical inhibition will be measured with simultaneous transcranial magnetic stimulation (TMS) and electroencephalography (EEG), TMS-EEG, which measures TMS-evoked EEG activity. Cognitive adverse effects associated with seizure therapy, on the contrary, will be evaluated via multiscale entropy analysis reflecting the complexity of ongoing resting-state EEG activity. Discussion ECT and MST are known to influence cortical inhibition associated with depression, suicidal ideation severity, and clinical outcome. Therefore, evaluating cortical inhibition and brain temporal dynamics will help understand the pathophysiology of depression and suicidal ideation and define new biological targets that could aid clinicians in diagnosing and selecting treatments. Resting-state EEG complexity was previously associated with the degree of cognitive side effects after a seizure therapy. This neurophysiological metric may help clinicians assess the risk for adverse effects caused by these useful and effective treatments. Trial registration ClinicalTrials.govNCT03191058. Registered on June 19, 2017.

Proportion of Individuals With Past-Year Suicidal Ideation Who Attempted Suicide Over the Past 10 Years in the United States, and the Influence of Age and Sex

Crisis ◽  
2020 ◽  
pp. 1-5
Author(s):  
Shannon Lange ◽  
Courtney Bagge ◽  
Charlotte Probst ◽  
Jürgen Rehm
Keyword(s):  
United States ◽  
Suicidal Ideation ◽  
Random Effects ◽  
Attempted Suicide ◽  
Suicide Attempts ◽  
The United States ◽  
Individual Level ◽  
The Past ◽  
Meta Analyses ◽  
Age Category

Abstract. Background: In recent years, the rate of death by suicide has been increasing disproportionately among females and young adults in the United States. Presumably this trend has been mirrored by the proportion of individuals with suicidal ideation who attempted suicide. Aim: We aimed to investigate whether the proportion of individuals in the United States with suicidal ideation who attempted suicide differed by age and/or sex, and whether this proportion has increased over time. Method: Individual-level data from the National Survey on Drug Use and Health (NSDUH), 2008–2017, were used to estimate the year-, age category-, and sex-specific proportion of individuals with past-year suicidal ideation who attempted suicide. We then determined whether this proportion differed by age category, sex, and across years using random-effects meta-regression. Overall, age category- and sex-specific proportions across survey years were estimated using random-effects meta-analyses. Results: Although the proportion was found to be significantly higher among females and those aged 18–25 years, it had not significantly increased over the past 10 years. Limitations: Data were self-reported and restricted to past-year suicidal ideation and suicide attempts. Conclusion: The increase in the death by suicide rate in the United States over the past 10 years was not mirrored by the proportion of individuals with past-year suicidal ideation who attempted suicide during this period.

Capturing the surge of public interest towards Hydroxychloroquine, Azithromycin and BCG vaccine during COVID-19 Pandemic (Preprint)

2020 ◽  
Author(s):  
Shabbir Syed-Abdul ◽  
Shwetambara Malwade ◽  
Sim-Mei Choo
Keyword(s):  
Social Media ◽  
Preventive Measures ◽  
Healthcare Providers ◽  
Specific Treatment ◽  
Drug Effects ◽  
The United States ◽  
Bcg Vaccine ◽  
Public Interests ◽  
Treatment Regimes ◽  
Appropriate Treatment

UNSTRUCTURED The outbreak of COVID-19 that started in December 2019, was declared a pandemic in March 2020. Currently, there is no specific treatment recommended and healthcare providers are struggling to find appropriate treatment regimes. Medication misinformation spread through social media has caused panic situations and self-prescription leading to harmful drug effects. The situation worsened following false propaganda via social media, leading to shortage of some medications. Our study shows the frequency of search for the medications Hydroxychloroquine (HCQ), Azithromycin and Bacillus Calmette-Guérin (BCG) vaccine in Google Trends, across 6 countries. Public interests from the United States, Italy and Spain leaned towards HCQ, whereas those from Taiwan, Japan and South Korea were keen towards learning about the BCG vaccine. Our article aimed to inform the general public of the adverse drug reactions to avoid self-prescription or yield to the assumptions of leaders and unanimous social media posts. Proactive participation and preventive measures such as social distancing, use of face masks and hand sanitizers are recommended to help curb COVID-19 and other infections.

scholarly journals National Estimates of Genetic Testing in Women With a History of Breast or Ovarian Cancer

2017 ◽  
Vol 35 (34) ◽  
pp. 3800-3806 ◽  
Author(s):  
Christopher P. Childers ◽  
Kimberly K. Childers ◽  
Melinda Maggard-Gibbons ◽  
James Macinko
Keyword(s):  
Ovarian Cancer ◽  
Genetic Testing ◽  
Unmet Need ◽  
Cancer Control ◽  
The United States ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Age Of Diagnosis ◽  
History Of ◽  
Interview Survey

Purpose In the United States, 3.8 million women have a history of breast (BC) or ovarian cancer (OC). Up to 15% of cases are attributable to heritable mutations, which, if identified, provide critical knowledge for treatment and preventive care. It is unknown how many patients who are at high risk for these mutations have not been tested and how rates vary by risk criteria. Methods We used pooled cross-sectional data from three Cancer Control Modules (2005, 2010, 2015) of the National Health Interview Survey, a national in-person household interview survey. Eligible patients were adult females with a history of BC and/or OC meeting select 2017 National Comprehensive Cancer Network eligibility criteria on the basis of age of diagnosis and family history. Outcomes included the proportion of individuals reporting a history of discussing genetic testing with a health professional, being advised to undergo genetic testing, or undergoing genetic testing for BC or OC. Results Of 47,218 women, 2.7% had a BC history and 0.4% had an OC history. For BC, 35.6% met one or more select eligibility criteria; of those, 29.0% discussed, 20.2% were advised to undergo, and 15.3% underwent genetic testing. Testing rates for individual eligibility criteria ranged from 6.2% (relative with OC) to 18.2% (diagnosis ≤ 45 years of age). For OC, 15.1% discussed, 13.1% were advised to undergo, and 10.5% underwent testing. Using only four BC eligibility criteria and all patients with OC, an estimated 1.2 to 1.3 million individuals failed to receive testing. Conclusion Fewer than one in five individuals with a history of BC or OC meeting select National Cancer Comprehensive Network criteria have undergone genetic testing. Most have never discussed testing with a health care provider. Large national efforts are warranted to address this unmet need.

How Research Will Adapt to HIPAA: A View from Within the Healthcare Delivery System

2002 ◽  
Vol 28 (4) ◽  
pp. 491-502
Author(s):  
Mary L. Durham
Keyword(s):  
Health Information ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
The United States ◽  
Personal Health Information ◽  
Personal Health ◽  
Business Associations ◽  
Electronic Information ◽  
Healthcare Delivery System ◽  
Institutional Review

While the new Health Insurance Privacy and Accountability Act (HIPAA) research rules governing privacy, confidentiality and personal health information will challenge the research and medical communities, history teaches us that the difficulty of this challenge pales in comparison to the potential harms that such regulations are designed to avoid. Although revised following broad commentary from researchers and healthcare providers around the country, the HIPAA privacy requirements will dramatically change the way healthcare researchers do their jobs in the United States. Given our reluctance to change, we risk overlooking potentially valid reasons why access to personal health information is restricted and regulated. In an environment of electronic information, public concern, genetic information and decline of public trust, regulations are ever-changing. Six categories of HIPAA requirements stand out as transformative: disclosure accounting/tracking, business associations, institutional review board (IRB) changes, minimum necessary requirements, data de-identification, and criminal and civil penalties.

scholarly journals The principles of physical restraint use for hospitalized elderly people: an integrated literature review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Azam Sharifi ◽  
Narges Arsalani ◽  
Masoud Fallahi-Khoshknab ◽  
Farahnaz Mohammadi-Shahbolaghi
Keyword(s):  
Elderly People ◽  
Scientific Information ◽  
Physical Restraint ◽  
Healthcare Providers ◽  
Routine Care ◽  
Ethical Challenges ◽  
Eligibility Criteria ◽  
Her Family ◽  
Hospitalized Elderly ◽  
Ensure Patient Safety

Abstract Background Physical restraint (PR) is a routine care measure in many hospital wards to ensure patient safety. However, it is associated with many different professional, legal, and ethical challenges. Some guidelines and principles have been developed in some countries for appropriate PR use. The present study aimed to explore the principles of PR use for hospitalized elderly people. Methods This was an integrative review. For data collection, a literature search was conducted in Persian and English databases, namely Magiran, Scientific Information Database (SID), Scopus, Google Scholar, Web of Science, and PubMed as well as the websites of healthcare organizations and associations. Eligibility criteria were publication in English or Persian between January 1, 2010, and January 1, 2021, and description of the principles of PR use for hospitalized elderly people. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used for document screening and selection, while the critical appraisal tools of the Joanna Briggs Institute (JBI) and the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument were used for quality appraisal. The data were analyzed through constant comparison. Results Primarily, 772 records were retrieved, while only twenty were eligible for the study. The principles of PR use for hospitalized elderly people were categorized into six main categories, namely principles of education for PR use, principles of decision making for PR use, principles of implementing the PR procedure, principles of monitoring patients with PR, principles of PR use documentation, and principles of PR management. Conclusion PR should be used only by trained healthcare providers, with the consent of patient or his/her family members, with standard devices and safe techniques, based on clear guidelines, and under close managerial supervision. Moreover, elderly people with PR should continuously be monitored for any PR-related complications. The findings of the present study can be used for developing clear PR-related guidelines.

scholarly journals Best Practices in Specialized Amyloidosis Centers in the United States: A Survey of Cardiologists, Nurses, Patients, and Patient Advocates

2021 ◽  
Vol 15 ◽  
pp. 117954682110152
Author(s):  
Jose Nativi-Nicolau ◽  
Nitasha Sarswat ◽  
Johana Fajardo ◽  
Muriel Finkel ◽  
Younos Abdulsattar ◽  
...  
Keyword(s):  
Best Practices ◽  
Patient Care ◽  
Nurse Practitioners ◽  
Healthcare Providers ◽  
Multidisciplinary Care ◽  
The United States ◽  
Comprehensive Care ◽  
Patient Support ◽  
Patient Support Group ◽  
Patient Advocates

Background: Because transthyretin amyloid cardiomyopathy (ATTR-CM) poses unique diagnostic and therapeutic challenges, referral of patients with known or suspected disease to specialized amyloidosis centers is recommended. These centers have developed strategic practices to provide multidisciplinary comprehensive care, but their best practices have not yet been well studied as a group. Methods: A qualitative survey was conducted by telephone/email from October 2019 to February 2020 among eligible healthcare providers with experience in the management of ATTR-CM at US amyloidosis centers, patients with ATTR-CM treated at amyloidosis centers, and patient advocates from amyloidosis patient support groups. Results: Fifteen cardiologists and 9 nurse practitioners/nurses from 15 selected amyloidosis centers participated in the survey, with 16 patients and 4 patient advocates. Among participating healthcare providers, the most frequently cited center best practices were diagnostic capability, multidisciplinary care, and time spent on patient care; the greatest challenges involved coordination of patient care. Patients described the “ideal” amyloidosis program as one that provides physicians with expertise in ATTR-CM, sufficient time with patients, comprehensive patient care, and opportunities to participate in research/clinical trials. The majority of centers host patient support group meetings, and patient advocacy groups provide support for centers with physician/patient education and research. Conclusions: Amyloidosis centers offer comprehensive care based on staff expertise in ATTR-CM, a multidisciplinary approach, advanced diagnostics, and time dedicated to patient care and education. Raising awareness of amyloidosis centers’ best practices among healthcare providers can reinforce the benefits of early referral and comprehensive care for patients with ATTR-CM.

scholarly journals Social stress and risk of declining cognition: a longitudinal study of men and women in the United States

2021 ◽  
Author(s):  
Jutta Lindert ◽  
Kimberley C. Paul ◽  
E. Lachman Margie ◽  
Beate Ritz ◽  
Teresa Seeman
Keyword(s):  
United States ◽  
Adverse Effects ◽  
Executive Functioning ◽  
Episodic Memory ◽  
Social Status ◽  
Social Stress ◽  
The United States ◽  
Subjective Social Status ◽  
Linear Regression Models ◽  
Men And Women

AbstractLimited research is available on the relationship between social stress and risk of declining cognition. We sought to examine whether social stress has adverse effects on risk of declining episodic memory and executive functioning in aging individuals. We used data from the MIDUS study, a national probability sample of non-institutionalized, English speaking respondents aged 25–74 living in the 48 contiguous states of the United States. The initial wave (1995) included 4963 non-institutionalized adults aged 32–84 (M = 55, SD = 12.4). We used an analytic sample from MIDUS-II (1996/1997) and MIDUS-III (2013) (n = 1821). The dependent variables are episodic memory and executive functioning, which were assessed with the Brief Test for Cognition (BTACT). The independent variables were social stress variables (subjective social status, family and marital stress, work stress and discrimination). To evaluate episodic memory and executive functioning changes over a time period of 10 years, we estimated adjusted linear regression models. Women report significantly lower subjective social status and more discrimination stress than men across all age groups. Controlling for education and income, age, and baseline episodic memory and executive functioning, lower subjective social status had additional adverse effects on declines in episodic memory in men and women. Marital risk had adverse effects on episodic memory in men but not in women. Daily discrimination had adverse effects on executive functioning on all individuals. Public health strategies should focus on reducing social stress in a socio-ecological perspective. Especially, subjective social status and discrimination stress might be a target for prevention efforts.

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