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1.
Am Surg ; 89(11): 4353-4359, 2023 Nov.
Article in English | MEDLINE | ID: mdl-35757933

ABSTRACT

BACKGROUND: Domestic violence (DV) worsened during COVID-19 and Family Justice Centers (FJCs) were, even more so than before, a critical part of providing services to DV victims. This study characterizes the clinical and sociodemographic features of the clients that come to the Ventura County FJC (VCFJC) and examines the effect of COVID-19, thus informing awareness of services available to victims of DV. METHODS: This was a retrospective cohort study utilizing the VCFJC database from 2019 to 2021. All client data normally collected was studied. A comparison of pre-COVID and post-COVID data was also conducted. RESULTS: There were 3488 client entries. Clients were mostly female (79% [2755]; n = 3488), aged 25-40 (31.73% [1106]; n = 3448), white/Caucasian (44.42% [1531]; n = 3448) or Hispanic/Latinx (42.41% [1462]; n = 3448). Clients most often requested restraining orders (72.41% [2496]; n = 3448), and most commonly reported DV [physical] (47.90% [1651]; n = 3448). Most health-insured clients were covered by MediCal (45.06% [1231]; n = 2732). Pre- and post-COVID analysis showed the highest increases in DV [physical] (odds ratio = 1.26, P < .0007) and stalking/harassment (odds ratio = 2.45, P < .0007), and decreases in all Initial Service Request categories except one. DISCUSSION: In serving clients affected by DV, FJCs are an important service for health care providers to be aware of. Post-COVID, clients reported DV and stalking/harassment at much higher percentages, which is consistent with national studies on the pandemic. The most alarming finding was the steep decrease in Initial Service Requests.Conclusion: This study shows the importance of collaboration and awareness of services, especially in a world of COVID-19.


Subject(s)
COVID-19 , Domestic Violence , Government Agencies , Female , Humans , Male , California/epidemiology , COVID-19/epidemiology , COVID-19/ethnology , Domestic Violence/ethnology , Domestic Violence/statistics & numerical data , Government Agencies/statistics & numerical data , Hispanic or Latino/statistics & numerical data , Local Government , Pandemics/statistics & numerical data , Retrospective Studies , White/statistics & numerical data , Adult
2.
J Public Health Manag Pract ; 27(3): 299-304, 2021.
Article in English | MEDLINE | ID: mdl-32487927

ABSTRACT

OBJECTIVE: To assess associations between state public health agency governance and timing and extent of implementation of social distancing control measures during COVID-19 response. DESIGN: State public health agencies were stratified by governance, and data on timing and extent of social distancing were collected from the Institute for Health Metrics and Evaluation. Multinomial logistic regression and time-to-event analyses were conducted to quantify impacts of governance structure on timing and extent of social distancing. SETTING: State health departments in the United States. RESULTS: States operating under centralized public health governance structures enacted social distancing 4 days after decentralized states and had a 73% reduced likelihood of enacting a social distancing policy (hazard ratio = 0.27; 95% CI, 0.08 to 0.86). CONCLUSION: State health department governance structure may have implications on timing and extent of social distancing control measures implemented during a public health emergency.


Subject(s)
COVID-19/prevention & control , Government Agencies/standards , Physical Distancing , Public Health Administration/statistics & numerical data , Public Health Administration/standards , Quarantine/standards , State Government , COVID-19/epidemiology , Government Agencies/statistics & numerical data , Humans , Quarantine/statistics & numerical data , SARS-CoV-2 , United States/epidemiology
3.
Pharmacoepidemiol Drug Saf ; 29(9): 1054-1063, 2020 09.
Article in English | MEDLINE | ID: mdl-32696556

ABSTRACT

PURPOSE: To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US). METHODS: This retrospective analysis examines medicines safety warnings issued by the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Therapeutic Goods Administration (TGA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) from January 1, 2007 until December 31, 2016. A database of warnings obtained from regulators' websites was developed and warnings were classified by communication type, drug, or therapeutic class focus, and the risk discussed. Advisories identifying the same drug or therapeutic class and risk were combined into groups termed "drug-risk issues" for comparisons between regulators. RESULTS: Over this 10-year period, 1441 advisories were identified, with the MHRA issuing the most advisories (MHRA = 469, FDA = 382, HC = 370 TGA = 220). Seventy two percent focussed on single drugs (1034/1441) and 58.7% were alerts (846/1441) posted on the regulators' websites. Diabetes drugs, smoking cessation drugs and immunomodulatory agents were the individual drug types most often subject to safety advisories, while antidepressants, antipsychotics, and proton-pump inhibitors were the top three therapeutic classes. Of 680 identified drug-risk issues, 3.8% (26/680) described a risk of death. By body system, cardiac effects were the most frequent: 10.4% (71/680). CONCLUSION: We found considerable differences in the use of advisories including frequency, communication type, and focus. Disparities in communication about emergent evidence on risks may mean that clinicians and patients in some countries are less well informed about medicine safety concerns than others.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/prevention & control , Government Agencies/statistics & numerical data , Prescription Drugs/adverse effects , Risk Evaluation and Mitigation/organization & administration , Antidepressive Agents/adverse effects , Antipsychotic Agents/adverse effects , Australia , Canada , Drug Labeling/statistics & numerical data , Humans , Hypoglycemic Agents/adverse effects , Immunologic Factors/adverse effects , Information Dissemination , Pharmacovigilance , Proton Pump Inhibitors/adverse effects , Retrospective Studies , Smoking Cessation Agents/adverse effects , United Kingdom , United States
4.
Chem Biol Interact ; 327: 109177, 2020 Aug 25.
Article in English | MEDLINE | ID: mdl-32533983

ABSTRACT

Since its inception in 1969, Chemico-Biological Interactions (CBI) has persistently published high quality research articles. As part of the journal's golden anniversary (50 years), we performed an electronic search on Scopus to get all publications details. Based on citescore, ranking & percentile, CBI holds 21st position in the top 113 relevant journals (in 2018). CBI also completed publications of 8005 manuscripts in March 2020. The highest documents were articles (6972/87.09%) followed by conference papers (588/7.34%) and reviews (252/3.14%). The maximum number of publications (385) was recorded in 2019, followed by 366 (in 2010) and 336 in 2016. Furthermore, details of the top 50 countries, top 50 authors and top 20 institutes with total publications, h-index, total citations and without selfcitations (WSC) are provided. USA (2371), China (786) and United Kingdom (658) are the top three countries, O'Brien, P.J (48), Maser, E. (45) and Lockridge, O. (35) are the top three authors and Karolinska Institutet (144), Stockholm University (102) & Ministry of Education China (94) are the top three institutes involved in research publications. More than eighty-four thousand (84,000) key words were amassed from scopus and after critical analysis we proposed a common sequence and connectivity. The top 200 articles, 200 reviews and 200 conference papers were analyzed by Vosviewer for various parameters. While, the top three (3) research articles and reviews are briefly described. The bibliometric analyses confirm a noteworthy growth of CBI in research publications and scientometric performance.


Subject(s)
Bibliometrics , Serial Publications/trends , Toxicology/trends , Academies and Institutes/statistics & numerical data , Authorship , Biomedical Research/statistics & numerical data , Government Agencies/statistics & numerical data , Humans , Review Literature as Topic , Universities/statistics & numerical data
5.
Isr J Health Policy Res ; 9(1): 14, 2020 05 04.
Article in English | MEDLINE | ID: mdl-32362275

ABSTRACT

BACKGROUND: Illicit performance-enhancing substances are used mostly by athletes to enhance performance in sports, and by bodybuilders to gain muscle and body mass. Among performance-enhancing substances, the most common and known substances are anabolic-androgenic steroids, which are associated with a range of short and long-term adverse medical and psychiatric effects. While the sale and distribution of performance-enhancing substances are considered criminal offenses per the Israeli local pharmacy ordinance, the use and personal possession of these substances are not. Presently, the Division of Enforcement and Inspection of the Israel Ministry of Health cooperates with police and customs agents in performance-enhancing substance-related enforcement activities, which chiefly include seizures carried out at suspicious sites. Moreover, the Division of Enforcement and Inspection provides professional guidance, lab analysis services, and expert opinions on the toxicological and pharmaceutical nature of products seized. This paper presents a contemporary sub-analysis of registered seizures of performance-enhancing substances carried-out by Israel enforcement agencies. The main aim of this analysis is to characterize current patterns of performance-enhancing substances, thus providing the possibility of better assessment of current enforcement and health policy. METHODS: A sub-analysis of 712 seizures of performance-enhancing substances seized by Israeli enforcement authorities during a six-year period ranging from January 2012 to December 2017. RESULTS: This study demonstrates that Israel faces a challenge regarding the importation and distribution of illicit performance-enhancing substances. The most common substances seized were anabolic androgenic steroids (N = 539). Most seizures were carried out in the central mail processing sites, (38.4%), followed by seizures in private premises such as homes and warehouses (29.6%). Significant differences were found between anabolic-androgenic steroids and other substances, relating to place and year of seizure. Among seizures with known sources (N = 355), the most frequent geographic region given as the source of substances was Eastern Europe (47.6%), followed by East Asia (24.8%), West Asia (19.4%), and Western Europe (5.9%). Bulgaria was the country with the highest frequency of seizures (N = 71) followed by Jordan (N = 45), Thailand (N = 37) and Moldova (N = 36). Significant regional differences were found based on the variables of gender, place of seizure, and type of substance. The most frequent month of seizures was August (N = 129), followed by July (N = 119), and June (N = 118). CONCLUSIONS: While data analysis focused on the supply side of the performance-enhancing substances market, the high number of seizures of performance-enhancing substances in Israel represents evidence of the existence of a high demand and a large consumer base for these products. Consequently, there is a need for developing further enforcement, treatment, and prevention policies that do not currently exist in Israel. Policymakers should consider prioritizing law enforcement action and incentivizing intelligence sharing to monitor suspected shipment sources and specific points of entry. Additionally, the results demonstrate that there is a need in reforming the penal law to discourage the use of performance-enhancing substances. Similar measures have already been applied in countries like Spain, Italy, and Belgium. Furthermore, policy-makers should consider enhancing health ministry agencies with a higher enforcement capacity by giving them further investigative and inquiry authority. Due to the troubling magnitude of the phenomenon, policymakers should also prioritize educational and prevention strategies.


Subject(s)
Government Agencies/statistics & numerical data , Health Policy , Performance-Enhancing Substances/standards , Social Control, Formal/methods , Government Agencies/organization & administration , Humans , Performance-Enhancing Substances/pharmacology
6.
J Pak Med Assoc ; 70(3): 523-525, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32207439

ABSTRACT

This study done in Hainan from March 2017 to June aimed to assess job satisfaction status and influencing factors among the staff of agencies for disease prevention and control in Hainan Province. A questionnaire survey was administered to some staff members at 6 centers for disease control and prevention in Hainan Province, job satisfaction in the questionnaire was rated on a 5-points Likert scale (totally agree, agree, not sure, disagree, totally disagree). The average score of job satisfaction for the six centers was 3.35±0.77, which was relatively low. According to the Wilcoxon rank-sum test, job satisfaction showed significant differences among different job titles (P <0.05). Logistic regression showed that the factors influencing job satisfaction were personal development space, rulesand regulations in CDC, personal safety, public health system, and workload. The factors influencing the staff's satisfaction are personal development space, rules and regulations in CDC, personal safety, public health system and workload.


Subject(s)
Attitude of Health Personnel , Communicable Disease Control/organization & administration , Job Satisfaction , Staff Development , Adult , China , Cross-Sectional Studies , Female , Government Agencies/standards , Government Agencies/statistics & numerical data , Humans , Male , Middle Aged , Public Health/methods , Staff Development/organization & administration , Staff Development/statistics & numerical data
7.
Clin Ther ; 42(2): 305-320.e0, 2020 02.
Article in English | MEDLINE | ID: mdl-32008723

ABSTRACT

PURPOSE: The present study aimed to examine the differences between enrolled subject populations and use of combination therapies as defined by the pivotal clinical trial protocols and the approved indications of anticancer drugs as determined by 3 major regulatory agencies. METHODS: Thirty-eight approvals were collected that received market authorization from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) between January 2010 and September 2018 for initial approval of an anticancer drug or for an expanded therapeutic indication for a previously approved anticancer drug, based on the same pivotal clinical trial(s). The subject eligibility criteria of the pivotal clinical trials and the approved indications as established by these agencies were compared, and the differences were categorized according to patient biomarkers status, prior treatment status, and the use of combination therapies. FINDINGS: In 20 (53%) approvals, there was a discrepancy between biomarker status of enrolled subjects in the pivotal trial and the therapeutic indication. In 7 of these cases, the biomarkers were used to diagnose the target cancer or to stratify the study subjects in the pivotal trial. In 9 cases, the biomarker discrepancies were related to minor histologic subtypes of the target cancer. Regarding prior treatment status, the FDA and the EMA generally approved indications for the same treatment line as the pivotal trials, whereas the PMDA did not restrict approval to untreated patients when the pivotal trial included only treatment-naive subjects. In 14 approvals, the FDA and the EMA designated the same co-administered drugs as part of the approved indications in line with the pivotal trials. However, the PMDA did not specify the co-administered drugs in 2 approvals and did not require combination therapy in 1 case. IMPLICATIONS: In principle, the approved therapeutic indications should be determined by the characteristics of the pivotal trial subjects and combination therapies. The use of biomarkers can be essential for identifying those patients who are most likely to benefit from a drug. Unfortunately, biomarker-defined subgroups are often insufficient in size to allow meaningful interpretation of results. Consequently, regulatory agencies may deviate from one another and from the pivotal trial protocol when interpreting study results and attempting to define the optimal treatment population. The PMDA-approved indications deviated more liberally from the pivotal trial protocols regarding specification of prior treatment status and the use of co-administered drugs.


Subject(s)
Antineoplastic Agents/therapeutic use , Clinical Trials as Topic/statistics & numerical data , Drug Approval/statistics & numerical data , Neoplasms/drug therapy , Drug Approval/organization & administration , Europe , Federal Government , Government Agencies/statistics & numerical data , Humans , Japan , Qualitative Research , United States
8.
Psychol Serv ; 17(2): 129-140, 2020 May.
Article in English | MEDLINE | ID: mdl-31045403

ABSTRACT

Limited research exists in the area of police mental wellness and suicide prevention, especially regarding programs utilized by these agencies. The purpose of this project was to gain a better understanding of the prevalence of use of police officer wellness promotion and suicide prevention programs implemented in the United States and an understanding of the perceptions of program effectiveness (Part A). We also sought to determine whether differences exist in the mental wellness and perspectives of programming of officers from agencies who utilize suicide prevention and wellness programs compared to those agencies who do not (Part B). Data for Part A was collected directly from agencies via a stratified random sample of city police departments and sheriff's offices nationwide. Part B entailed completion of online surveys by individual officers from agencies participating in Part A. The final sample included 55 agencies for Part A and 144 officers for Part B. At the agency level (Part A), Employee Assistance Programs or counseling services were the most common programs offered, and, notably, planning for programming was inconsistent or not well established. At the officer level (Part B), almost 25% of respondents did not know whether their agency had programming; 35% did not feel their agency supports its officers' mental wellness. For officers who did feel their wellness was supported, they reported significantly less stress and higher overall well-being. Of officer respondents, 12.4% indicated it was either "quite" or "very likely" they would attempt suicide someday. Implications and suggestions for law enforcement agencies are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).


Subject(s)
Government Agencies/statistics & numerical data , Health Promotion/statistics & numerical data , Law Enforcement , Patient Acceptance of Health Care/statistics & numerical data , Police/psychology , Police/statistics & numerical data , Suicide Prevention , Adult , Female , Humans , Male , Program Development , Program Evaluation , United States
9.
Clin Pharmacol Ther ; 107(1): 195-202, 2020 01.
Article in English | MEDLINE | ID: mdl-31306483

ABSTRACT

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies' decisions on drug marketing applications. Decisions were compared for 107 new drug applications with a regulatory outcome at both agencies in the period 2014-2016. Further analysis addressed individual applications for which the agencies had differing outcomes in terms of marketing approval, type of approval, and approved indication, including reasons underlying differences. The EMA and the FDA had high concordance (91-98%) in decisions on marketing approvals. Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies' conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application. This high rate of concordance suggests that engagement and collaboration on regulatory science has a positive impact.


Subject(s)
Drug Approval/statistics & numerical data , Government Agencies/statistics & numerical data , United States Food and Drug Administration/statistics & numerical data , Decision Making , Europe , Humans , United States
10.
J Nepal Health Res Counc ; 17(3): 285-287, 2019 Nov 13.
Article in English | MEDLINE | ID: mdl-31735918

ABSTRACT

BACKGROUND: In Nepal, promoting quality research and enhancing research capacity is being accomplished through Nepal Health Research Council (NHRC). It also plays an authorized body to regulate, monitor and coordinate health research centers by maintaining the highest level of ethical standards. The aim of this study is to explore situation of health agencies designated as research center in Nepal. METHODS: A cross sectional descriptive study design was used to carry out monitoring and follow up of activities of research centre of all seven provinces of Nepal that had title "Research" in their title name from January 2018 to July 2018. RESULTS: There were only 81 research centers in Nepal and more than half (55 percent) of these have been found in Kathmandu valley, Province 3. Research found that 82.3% so called research centers were just health service provider and 10% of research institute were research based and just 5% have the core objectives of research. Likewise, 30% of research institute were actually involved in health related researches whereas large proportion (70%) of research institute were not involved in any kind of research work. Surprisingly, only 37.5% have taken ethical approval to conduct the designated research. CONCLUSIONS: Only one tenth of the research centers have mentioned research as their core business. However, less than one third of such centers were involved in heath research, and out of which, only 28 percent took ethical permission. Most of the research organizations want to conduct research but they do not have required research skills and competent manpower to carry out research.


Subject(s)
Biomedical Research , Government Agencies/organization & administration , Biomedical Research/organization & administration , Biomedical Research/statistics & numerical data , Cross-Sectional Studies , Government Agencies/statistics & numerical data , Humans , Nepal
11.
Am J Public Health ; 109(3): 437-444, 2019 03.
Article in English | MEDLINE | ID: mdl-30676804

ABSTRACT

In this article, we examine the role of nongovernmental entities (NGEs; nonprofits, religious groups, and businesses) in disaster response and recovery. Although media reports and the existing scholarly literature focus heavily on the role of governments, NGEs provide critical services related to public safety and public health after disasters. NGEs are crucial because of their ability to quickly provide services, their flexibility, and their unique capacity to reach marginalized populations. To examine the role of NGEs, we surveyed 115 NGEs engaged in disaster response. We also conducted extensive field work, completing 44 hours of semistructured interviews with staff from NGEs and government agencies in postdisaster areas in Texas, Florida, Puerto Rico, Northern California, and Southern California. Finally, we compiled quantitative data on the distribution of nonprofit organizations. We found that, in addition to high levels of variation in NGE resources across counties, NGEs face serious coordination and service delivery problems. Federal funding for expanding the capacity of local Voluntary Organizations Active in Disaster groups, we suggest, would help NGEs and government to coordinate response efforts and ensure that recoveries better address underlying social and economic vulnerabilities.


Subject(s)
Disasters/economics , Government Agencies/economics , Natural Disasters/economics , Organizations, Nonprofit/economics , Public Health/economics , California , Disasters/statistics & numerical data , Florida , Government Agencies/statistics & numerical data , Organizations, Nonprofit/statistics & numerical data , Public Health/statistics & numerical data , Puerto Rico , Texas
12.
Schizophr Res ; 203: 49-54, 2019 01.
Article in English | MEDLINE | ID: mdl-28768601

ABSTRACT

Cognitive remediation (CR) research typically addresses internal validity, and few studies consider CR in a real-world context. This study evaluated the fit between the program conditions and treatment model in research and clinical settings, with the goal of informing future research on the contextual challenges associated with the implementation of CR. Data was drawn from an initiative by New York State's Office of Mental Health (OMH), to implement CR programs for adults with Serious Mental Illness (SMI) in 16 state operated outpatient clinics. One of these clinics first became a research site for a CR randomized clinical trial, which allowed for a comparison of the feasibility and acceptability of CR in a research as compared to a clinical setting. RESULTS: The research site averaged almost triple the number of referrals as the clinical sites. Over nine months 46.51% of clinic referrals were enrolled in the CR program whereas 64.29% of research referrals were enrolled. Clinical site utilization averaged 70.53% while research site utilization averaged 90.47%. At the clinical sites, 97% of respondents reported CR was an excellent or good experience. There was high treatment fidelity for program structure and content across sites. CONCLUSIONS: This comparison of CR in clinical and research sites highlights the decrease in referrals, enrollment and utilization that occurs when a program moves from a highly controlled setting to the real world. Still, the acceptability, fill rates and utilization indicated that CR can be successfully implemented in large scale, geographically diverse, publically funded clinic settings.


Subject(s)
Ambulatory Care Facilities/statistics & numerical data , Cognitive Remediation/statistics & numerical data , Mental Health Services/statistics & numerical data , Outcome and Process Assessment, Health Care/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Psychotic Disorders/rehabilitation , Referral and Consultation/statistics & numerical data , Schizophrenia/rehabilitation , Biomedical Research/statistics & numerical data , Cognitive Behavioral Therapy/statistics & numerical data , Feasibility Studies , Government Agencies/statistics & numerical data , Humans , New York , Patient Satisfaction , Program Development , Randomized Controlled Trials as Topic , State Government
13.
J Immigr Minor Health ; 21(3): 439-442, 2019 Jun.
Article in English | MEDLINE | ID: mdl-29959652

ABSTRACT

Between November 2015 and January 2017, the Government of Canada resettled over 40,000 Syrian refugees through different sponsorship programs (GAR and PSR). Timely access to healthcare is essential for good health and successful integration. However, refugee support differs depending on sponsorship program, which may lead to differences in healthcare service access and needs. A cross-sectional study with a sample of Syrian refugees was conducted to assess healthcare access, and perceived physical and mental health status. Results indicate demographic and healthcare access differences between GARs and PSRs. GARs reported significantly lower perceived physical and mental health, as well as, higher unmet healthcare needs than PSRs. GARs are among the most vulnerable refugees; they report higher needs, more complex medical conditions and tend to have more difficulty re-settling. These factors likely combine to help explain lower self-reported health and higher health needs in our sample compared to PSRs.


Subject(s)
Health Services Accessibility/statistics & numerical data , Health Services Needs and Demand/statistics & numerical data , Health Status , Mental Health/ethnology , Refugees/statistics & numerical data , Adult , Age Factors , Canada/epidemiology , Cross-Sectional Studies , Female , Government Agencies/statistics & numerical data , Humans , Logistic Models , Male , Mental Health Services/statistics & numerical data , Middle Aged , Organizations/statistics & numerical data , Self Report , Sex Factors , Socioeconomic Factors , Syria/ethnology , Vulnerable Populations/ethnology
14.
Int J Health Serv ; 49(1): 142-164, 2019 01.
Article in English | MEDLINE | ID: mdl-30428268

ABSTRACT

This scoping review identified what kinds of work disability policy issues are critiqued in articles published in countries with cause-based versus comprehensive welfare systems. Drawing on a review of work disability policy research, we identified 74 English-language, peer-reviewed articles that focused on program adequacy and design. Articles on cause-based systems dwelled on system fairness and policies of proof of entitlement, while those on comprehensive systems focused more on system design complexities relating to worker inclusion and scope of medical certificates. Overall, we observed a clear difference in the nature of problems examined in the different systems. Gaps in work disability policy literature are identified, and challenges for comparative policy research are discussed.


Subject(s)
Policy , Social Security/organization & administration , Social Security/statistics & numerical data , Workers' Compensation/organization & administration , Workers' Compensation/statistics & numerical data , Documentation/standards , Eligibility Determination/standards , Government Agencies/organization & administration , Government Agencies/statistics & numerical data , Humans , Industry/organization & administration , Industry/statistics & numerical data , Insurance Carriers/statistics & numerical data , Return to Work , Risk Factors , Social Security/standards , Work Capacity Evaluation , Workers' Compensation/standards
15.
Psychol Serv ; 16(1): 134-142, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30431307

ABSTRACT

In response to the growing awareness of the high rates of potentially traumatic experiences and their potential adverse impacts, health and human service providers have increasingly focused on implementing trauma-informed care (TIC). However, studies focusing on effective implementation have been limited. In this study, we explored the relationship of individual and agency characteristics to the level of organizational TIC. With data collected from a sample of 345 providers from 67 agencies, we used the TICOMETER, a brief measure of organizational TIC with strong psychometric properties, to determine these associations. We found weak relationships between individual factors and TICOMETER scores and stronger associations for agency-level factors. These included agency type, time since last trauma training, and involvement of service users. These findings highlight the importance of robust cultural changes, service user involvement at all levels of the organization, flattening power differentials, and providing ongoing experiential training. This analysis fills an important gap in our knowledge of how best to ensure agency-wide provision of TIC. (PsycINFO Database Record (c) 2019 APA, all rights reserved).


Subject(s)
Efficiency, Organizational , Government Agencies , Health Personnel , Professional Competence , Psychological Trauma/therapy , Psychometrics/instrumentation , Staff Development , Adult , Efficiency, Organizational/statistics & numerical data , Female , Government Agencies/statistics & numerical data , Health Personnel/education , Humans , Male , Middle Aged , Staff Development/statistics & numerical data
16.
Health Secur ; 16(5): 281-303, 2018.
Article in English | MEDLINE | ID: mdl-30339096

ABSTRACT

This article is the latest in an annual series analyzing federal funding for health security programs. We examine proposed funding in the President's Budget Request for FY2019, provide updated amounts for FY2018, and update actual funding amounts for FY2010 through FY2017. Building health security for the nation is the responsibility of multiple agencies in the US federal government, as well as that of state, tribal, territorial, and local governments and the private sector. This series of articles focuses on the federal government's role in health security by identifying health security-related programs in public health, health care, national security, and defense and reporting funding levels for that ongoing work.


Subject(s)
Bioterrorism/economics , Financing, Government/statistics & numerical data , Government Agencies/statistics & numerical data , Security Measures/economics , Budgets/trends , Chemical Terrorism , Civil Defense/economics , Financing, Government/economics , Financing, Government/trends , Government Agencies/economics , Humans , Pandemics , Public Health/economics
17.
Eur J Clin Pharmacol ; 74(6): 811-818, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29470610

ABSTRACT

INTRODUCTION: This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. METHODS: The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x2-tests were performed for the analysis. RESULTS: From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant. The indications approved by the FDA, the EMA, and SMC for the same drugs were similar in content for 23.1% drugs and different in 76.9% of the drugs. Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC. CONCLUSION: There were differences in the characteristics of new drugs approved by the EMA, the FDA, and SMC in the period 2007-2016. Overall, two thirds of the new drugs were first approved by the FDA. Differences in indications were found in three out of four new drugs approved by the three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new drugs approved by different agencies persist.


Subject(s)
Drug Approval/statistics & numerical data , Government Agencies/statistics & numerical data , Drug Approval/organization & administration , Europe , Internationality , United States
18.
J Psychiatr Res ; 98: 116-123, 2018 03.
Article in English | MEDLINE | ID: mdl-29334636

ABSTRACT

A substantial and variable placebo response can cause unreliable findings in clinical trials designed to demonstrate the efficacy of antidepressants, and the high rate of failed trials represents a major obstacle in the development of new drugs for major depressive disorder (MDD). However, the influence of demographic and symptom factors on the antidepressant effect remains to be established. The purpose of this study was to estimate the magnitude of this influence. A patient-level meta-analysis of data from double-blind, randomized, placebo-controlled trials involving the use of antidepressants for adults with MDD was performed. Data from five confirmatory trials evaluating the efficacy of four antidepressants that were submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) to support new drug applications were pooled (n = 1898). The change in the total score of 17-item Hamilton Depression Rating Scale (HDRS17) was the primary outcome of interest in our analysis. The changes in the total HDRS17 score in both the antidepressant medication group (ADM) and the placebo group (PBO) increased in relation to baseline symptom severity. Among older patients and those with a history of prior treatment with antidepressants, the changes in the total HDRS17 score decreased in ADM and remained static in PBO. There were no notable clinical symptoms that influenced the change in the total HDRS17 score. Baseline symptom severity, participant age and a history of previous treatment with antidepressants were suggested as moderators of the antidepressant effect. The drug-placebo difference in the estimated changes as a function of baseline symptom severity varied depending on the regression models used, and further studies are required to investigate appropriate models.


Subject(s)
Antidepressive Agents/pharmacology , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/epidemiology , Outcome Assessment, Health Care/statistics & numerical data , Randomized Controlled Trials as Topic/statistics & numerical data , Adult , Aged , Female , Government Agencies/statistics & numerical data , Humans , Japan , Male , Middle Aged , Young Adult
19.
Annu Rev Public Health ; 39: 437-452, 2018 04 01.
Article in English | MEDLINE | ID: mdl-29272166

ABSTRACT

Rich federal data resources provide essential data inputs for monitoring the health and health care of the US population and are essential for conducting health services policy research. The six household surveys we document in this article cover a broad array of health topics, including health insurance coverage (American Community Survey, Current Population Survey), health conditions and behaviors (National Health Interview Survey, Behavioral Risk Factor Surveillance System), health care utilization and spending (Medical Expenditure Panel Survey), and longitudinal data on public program participation (SIPP). New federal activities are linking federal surveys with administrative data to reduce duplication and response burden. In the private sector, vendors are aggregating data from medical records and claims to enhance our understanding of treatment, quality, and outcomes of medical care. Federal agencies must continue to innovate to meet the continuous challenges of scarce resources, pressures for more granular data, and new multimode data collection methodologies.


Subject(s)
Data Collection/methods , Government Agencies/statistics & numerical data , Research Design , Health Behavior , Health Expenditures/statistics & numerical data , Health Services , Health Services Research/methods , Humans , Insurance Coverage/statistics & numerical data , Insurance, Health/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , United States
20.
Public Health Rep ; 132(6): 646-653, 2017.
Article in English | MEDLINE | ID: mdl-29072961

ABSTRACT

OBJECTIVE: We estimated the reduction in number of hospitalizations for acute myocardial infarction and stroke as well as the associated health care costs resulting from reducing the number of smokers in the US federal workforce during a 5-year period. METHODS: We developed a 5-year spreadsheet-based cohort model with parameter values from past literature and analysis of national survey data. We obtained 2015 data on the federal workforce population from the US Office of Personnel Management and data on smoking prevalence among federal workers from the 2013-2015 National Health Interview Survey. We adjusted medical costs and productivity losses for inflation to 2015 US dollars, and we updated future productivity losses for growth. Because of uncertainty about the achievable reduction in smoking prevalence and input values (eg, relative risk for acute myocardial infarction and stroke, medical costs, and absenteeism), we performed a Monte Carlo simulation and sensitivity analysis. RESULTS: We estimated smoking prevalence in the federal workforce to be 13%. A 5 percentage-point reduction in smoking prevalence could result in 1106 fewer hospitalizations for acute myocardial infarction (range, 925-1293), 799 fewer hospitalizations for stroke (range, 530-1091), and 493 fewer deaths (range, 494-598) during a 5-year period. Similarly, estimated costs averted would be $59 million (range, $49-$63 million) for medical costs, $332 million (range, $173-$490 million) for absenteeism, and $117 million (range, $93-$142 million) for productivity. CONCLUSION: Reductions in the prevalence of smoking in the federal workforce could substantially reduce the number of hospitalizations for acute myocardial infarction and stroke, lower medical costs, and improve productivity.


Subject(s)
Health Expenditures/statistics & numerical data , Myocardial Infarction/economics , Smoking Cessation/economics , Smoking/epidemiology , Stroke/economics , Absenteeism , Adult , Cost-Benefit Analysis , Efficiency , Female , Government Agencies/statistics & numerical data , Humans , Male , Middle Aged , Models, Econometric , Monte Carlo Method , Myocardial Infarction/epidemiology , Prevalence , Stroke/epidemiology , United States/epidemiology , Young Adult
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