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1.
Obstet Gynecol ; 136(4): 645-653, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925616

RESUMO

OBJECTIVE: To estimate the proportion of accidental drug-related deaths and suicides classified as pregnancy-related from 2013 to 2014 (preimplementation of standardized criteria) and 2015 to 2016 (postimplementation). METHODS: Based on Centers for Disease Control and Prevention pregnancy-related death criteria, the Utah Perinatal Mortality Review Committee developed a standardized evaluation tool to assess accidental drug-related death and suicide beginning in 2015. We performed a retrospective case review of all pregnancy-associated deaths (those occurring during pregnancy or 1 year postpartum for any reason) and pregnancy-related deaths (those directly attributable to the pregnancy or postpartum events) evaluated by Utah's Perinatal Mortality Review Committee from 2013 to 2016. We compared the proportion of accidental drug-related deaths and suicides meeting pregnancy-related criteria preimplementation and postimplementation of a standardized criteria checklist tool using Fisher's exact test. We assessed the change in pregnancy-related mortality ratio in Utah from 2013 to 2014 and 2015 to 2016 using test of trend. RESULTS: From 2013 to 2016, there were 80 pregnancy-associated deaths in Utah (2013-2014: n=40; 2015-2016: n=40), and 41 (51%) were pregnancy-related (2013-2014: n=15, 2015-2016: n=26). In 2013-2014 (preimplementation), 12 women died of drug-related deaths or suicides, and only two of these deaths were deemed pregnancy-related (17%). In 2015-2016 (postimplementation), 18 women died of drug-related deaths or suicide, and 94% (n=17/18) of these deaths met one or more of the pregnancy-related criteria on the checklist (P<.001). From 2013 to 2014 to 2015-2016, Utah's overall pregnancy-related mortality ratio more than doubled, from 11.8 of 100,000 to 25.7 of 100,000 (P=.08). CONCLUSION: After application of standardized criteria, the Utah Perinatal Mortality Review Committee determined that pregnancy itself was the inciting event leading to the majority of accidental drug-related deaths or suicides among pregnant and postpartum women. Other maternal mortality review committees may consider a standardized approach to assessing perinatal suicides and accidental drug-related deaths.


Assuntos
Prevenção de Acidentes , Uso Indevido de Medicamentos , Revisão por Pares/normas , Complicações na Gravidez , Transtornos Puerperais/mortalidade , Suicídio , Adulto , Comitês Consultivos/estatística & dados numéricos , Uso Indevido de Medicamentos/mortalidade , Uso Indevido de Medicamentos/prevenção & controle , Falha da Terapia de Resgate/estatística & dados numéricos , Feminino , Humanos , Mortalidade Materna/tendências , Mortalidade , Gravidez , Complicações na Gravidez/mortalidade , Complicações na Gravidez/prevenção & controle , Suicídio/prevenção & controle , Suicídio/estatística & dados numéricos , Utah/epidemiologia
2.
Obstet Gynecol ; 136(4): 657-662, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925626

RESUMO

The maternal mortality ratio in the United States is increasing; understanding the significance of this change and developing effective responses requires a granular analysis of the contributing factors that a well-informed maternal mortality review committee can provide. Data collection and analysis, clinical factors, preventability, social determinants of health, and racial inequities combine to affect this outcome, and each factor must be considered individually and in combination to recommend a robust response. Obstetrician-gynecologists formed the State of Michigan's Maternal Mortality Review Committee (the Committee) in 1950 to identify gaps in care that needed to be systematically addressed at the time. In the early years, the Committee witnessed a reduction in the number of maternal deaths; over time, prioritization of maternal mortality decreased, yet the Committee witnessed changing patterns of death, varied data collection and evaluation processes, delayed reviews, and unimplemented recommendations. The calculation of the maternal mortality ratio was not informed by the outcomes of Committee reviews. Today, the Committee, with increased support from the Michigan Department of Health & Human Services, can clearly identify and report preventable pregnancy-related mortality along with its causes and is close to achieving a near real-time surveillance system that allows the development of timely clinical and policy recommendations and interventions. The Committee's adaptations in response to the rise in maternal mortality have resulted in several lessons learned that may be helpful for currently operating committees and in the formation of new ones.


Assuntos
Uso Indevido de Medicamentos , Mortalidade Materna/tendências , Complicações na Gravidez , Serviços Preventivos de Saúde , Melhoria de Qualidade , Suicídio , Adulto , Comitês Consultivos/normas , Comitês Consultivos/estatística & dados numéricos , Uso Indevido de Medicamentos/mortalidade , Uso Indevido de Medicamentos/prevenção & controle , Falha da Terapia de Resgate/estatística & dados numéricos , Feminino , Disparidades em Assistência à Saúde/normas , Humanos , Michigan/epidemiologia , Mortalidade , Gravidez , Complicações na Gravidez/mortalidade , Complicações na Gravidez/prevenção & controle , Serviços Preventivos de Saúde/métodos , Serviços Preventivos de Saúde/normas , Melhoria de Qualidade/organização & administração , Melhoria de Qualidade/tendências , Determinantes Sociais da Saúde/etnologia , Suicídio/prevenção & controle , Suicídio/estatística & dados numéricos
3.
Ann Thorac Surg ; 110(3): 1082-1090, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32418630

RESUMO

BACKGROUND: The Society of Thoracic Surgeons (STS) has intermittently surveyed its workforce, providing isolated accounts of the current state of thoracic surgical practice. METHODS: The 70-question survey instrument was received by 3834 STS surgeon members, and responses were gathered between September 16 and November 1, 2019. The return rate was 27.9%. RESULTS: The median age of the active United States (US) thoracic surgeons is 56 years. Women comprise 8.4% of the responders, constituting 6.2% of adult cardiac, 10.6% of congenital heart, and 12.6% of general thoracic surgeons. Most practicing US surgeons (83.5%) graduated from medical school in the US. Survey respondents had 7 (21.8%), 8 (25.0%), 9 (22.1%) or 10 (29.2%) or more years of post-MD training before entering practice. Educational debt was increased compared with previous years, as were salaries. Overall career satisfaction was 54.1% (very or extremely satisfied), and overall average hours per week worked decreased compared with past surveys. However, 55.7% of surgeons had symptoms of burnout and depression. STS Database participation was high (90.5%), with the most common reason for not participating being cost (32.6%). Operative volume over the past 12 months decreased for 23.7% of surgeons. Of those who responded, 46.9% plan to retire between the age of 66 and 69 years and a further 25.6% at age 70 or older. CONCLUSIONS: These data provide a current, detailed profile of the specialty. Ongoing challenges remain length of training and educational debt. Case volumes, scope of practice, and career satisfaction have remained relatively constant: however, symptoms of burnout or depression or both, are common.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Educação de Pós-Graduação em Medicina/métodos , Satisfação no Emprego , Sociedades Médicas , Cirurgia Torácica , Procedimentos Cirúrgicos Torácicos/educação , Recursos Humanos , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Estados Unidos
4.
Cancer ; 126(4): 717-724, 2020 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-31794057

RESUMO

BACKGROUND: We sought to determine the extent to which US Preventive Services Task Force (USPSTF) 2012 Grade D recommendations against prostate-specific antigen screening may have impacted recent prostate cancer disease incidence patterns in the United States across stage, National Comprehensive Cancer Network (NCCN) risk groups, and age groups. METHODS: SEER*Stat version 8.3.4 was used to calculate annual prostate cancer incidence rates from 2010 to 2015 for men aged ≥50 years according to American Joint Committee on Cancer stage at diagnosis (localized vs metastatic), NCCN risk group (low vs unfavorable [intermediate or high-risk]), and age group (50-74 years vs ≥75 years). Age-adjusted incidences per 100,000 persons with corresponding year-by-year incidence ratios (IRs) were calculated using the 2000 US Census population. RESULTS: From 2010 to 2015, the incidence (per 100,000 persons) of localized prostate cancer decreased from 195.4 to 131.9 (Ptrend  < .001) and from 189.0 to 123.4 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. The largest relative year-by-year decline occurred between 2011 and 2012 in NCCN low-risk disease (IR, 0.77 [0.75-0.79, P < .0001] and IR 0.68 [0.62-0.74, P < .0001] for men aged 50-74 and ≥75 years, respectively). From 2010-2015, the incidence of metastatic disease increased from 6.2 to 7.1 (Ptrend  < .001) and from 16.8 to 22.6 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. CONCLUSIONS: This report illustrates recent prostate cancer "reverse migration" away from indolent disease and toward more aggressive disease beginning in 2012. The incidence of localized disease declined across age groups from 2012 to 2015, with the greatest relative declines occurring in low-risk disease. Additionally, the incidence of distant metastatic disease increased gradually throughout the study period.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Serviços Preventivos de Saúde/estatística & dados numéricos , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico , Comitês Consultivos/organização & administração , Comitês Consultivos/normas , Idoso , Detecção Precoce de Câncer/métodos , Humanos , Incidência , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Serviços Preventivos de Saúde/organização & administração , Serviços Preventivos de Saúde/normas , Neoplasias da Próstata/sangue , Neoplasias da Próstata/epidemiologia , Fatores de Risco , Programa de SEER/estatística & dados numéricos , Estados Unidos/epidemiologia
6.
Nagoya J Med Sci ; 81(3): 501-509, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31579340

RESUMO

The survey involves examining the applications from 142 institutions that have consented to make available all certification applications from 2015 and 2016 to a research project for building a certification system for an ethics committee run by the Agency for Medical Research and Development. The number of certified institutions is 20 (14.1%). In the applications from uncertified institutions, there are cases in which requirements of ethics guidelines are unmet, and there is insufficient information provided on regulation and procedure. An analysis of the committee members who can contribute as members of the general public (general public committee members) has indicated that the number of committee members who do not belong to an institution in which an ethics committee is instituted (external committee members) is 41 (95.7%) among the certified institutions and 224 (84.5%) among the uncertified institutions. The proportion of general public committee members drawn internally from institutions tends to be higher among uncertified institutions. While a separate committee examined conflicts of interest in research in 19 certified institutions (95.0%), such conflicts were found in 41 uncertified institutions (33.9%) by the ethics committee. The survey confirms that the challenge lies in increasing the number of external committee members and in further improving the system to manage conflicts of interest, and the education and training regime.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Comitês de Ética em Pesquisa/estatística & dados numéricos , Pesquisa Biomédica/ética , Revisão Ética , Humanos , Japão
8.
Mult Scler Relat Disord ; 25: 144-149, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30077086

RESUMO

BACKGROUND: In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) advises on the reimbursement of drugs to be subsidised through the Pharmaceutical Benefits Scheme (PBS). This study aims to provide insights into the PBAC process and key considerations regarding the reimbursement of MS drugs in Australia. METHODS: The factors considered by the PBAC and its advice on whether to reimburse a drug are documented in public summary documents (PSDs). Qualitative content analysis of PSDs was conducted for all MS drugs considered by the PBAC between January 2006 and January 2018. Key issues identified by the PBAC were extracted and categorised. Common issues were identified and compared between drugs indicated for MS. RESULTS: A total of 23 submissions were evaluated relating to 13 MS drugs. Eight were recommended for reimbursement; an approval rate of 35% per submission and 62% per drug. Approval rates were higher for disease modifying treatments (73% per drug) than for symptomatic drugs (0% for nabiximols and fampridine submissions). The most frequently discussed issues in PSDs, irrespective of PBAC decision, were: (1) the validity of the indirect comparisons formed (n = 11); (2) the validity of the approach to obtain utilities (n = 6); (3) the lack of appropriate/long-term safety data (n = 8); and (4) the time horizon used in the economic models (n = 3). CONCLUSION: A small but important number of issues have been consistently identified by the PBAC in relation to submissions for reimbursement of MS drugs. Drug developers and clinical trial investigators who are aware of these issues will be able to anticipate data requirements for reimbursement decision-making and thus potentially improve the evidence submitted for listing of MS drugs in Australia.


Assuntos
Comitês Consultivos/normas , Tomada de Decisões , Aprovação de Drogas/métodos , Fatores Imunológicos/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/psicologia , Comitês Consultivos/estatística & dados numéricos , Austrália/epidemiologia , Análise Custo-Benefício , Aprovação de Drogas/economia , Feminino , Humanos , Fatores Imunológicos/economia , Masculino , Estudos Retrospectivos
9.
Pharmacoeconomics ; 36(5): 613-624, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29520603

RESUMO

BACKGROUND: The All Wales Medicines Strategy Group (AWMSG) develops prescribing advice and is responsible for appraising new medicines for use in Wales. In this article, we examine the medicines appraisal process in Wales, its timeliness and its impact on medicines availability in Wales, and compare its processes and recommendations with the two other UK health technology appraisal bodies [the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC)]. METHODS: We reviewed the medicines appraisals conducted by AWMSG between October 2010 and September 2015. The duration of the process and the recommendations made by AWMSG were compared with those of NICE and SMC. Only publicly available data were considered in this review. RESULTS: AWMSG conducted 171 single technology appraisals for 137 medicines during the study period (34 were for medicines previously appraised by AWMSG but these were for new indications). Of these, 152 appraisals were supported for use in NHS Wales (33 with restrictions) and 19 were not supported. Recommendations broadly concurred with SMC and NICE for the majority of appraisals. Compared with NICE recommendations, the median time advantage gained in Wales for those medicines that received a positive AWMSG recommendation and which were subsequently superseded by NICE advice was 10.6 months (range 3.5-48.3 months; n = 17). CONCLUSION: This review highlights the work carried out by AWMSG over a 5-year period, and provides evidence to support the effectiveness of the appraisal process in terms of patients in Wales gaining earlier access to medicines and efficiency through reduced duplication with NICE.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Análise Custo-Benefício/métodos , Tomada de Decisões , Avaliação da Tecnologia Biomédica/métodos , Humanos , Guias de Prática Clínica como Assunto , Escócia , Fatores de Tempo , Reino Unido , País de Gales
10.
Child Abuse Negl ; 74: 1-9, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29037437

RESUMO

The Royal Commission into Institutional Responses to Child Sexual Abuse is the largest royal commission in Australia's history and one of the largest public inquiries into institutional child abuse internationally. With an investment from the Australian government of half a billion dollars, it examined how institutions with a responsibility for children, both historically and in the present, have responded to allegations of child sexual abuse. Announced in the wake of previous Australian and international inquiries, public scandals and lobbying by survivor groups, its establishment reflected increasing recognition of the often lifelong and intergenerational damage caused by childhood sexual abuse and a strong political commitment to improving child safety and wellbeing in Australia. This article outlines the background, key features and innovations of this landmark public inquiry, focusing in particular on its extensive research program. It considers its international significance and also serves as an introduction to this special edition on the Australian Royal Commission, exploring its implications for better understanding institutional child sexual abuse and its impacts, and for making institutions safer places for children in the future.


Assuntos
Comitês Consultivos , Abuso Sexual na Infância/prevenção & controle , Abuso Sexual na Infância/estatística & dados numéricos , Prática Institucional , Comitês Consultivos/legislação & jurisprudência , Comitês Consultivos/estatística & dados numéricos , Austrália , Criança , Abuso Sexual na Infância/legislação & jurisprudência , Comparação Transcultural , Estudos Transversais , Humanos , Prática Institucional/legislação & jurisprudência , Prática Institucional/estatística & dados numéricos
11.
J Oncol Pract ; 13(12): e982-e991, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-29019706

RESUMO

PURPOSE: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. We sought to evaluate the effect of this process on protocol activation timelines. METHODS: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher's exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression. RESULTS: A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/clarifications, and 73 days for four or more changes/clarifications ( P < .001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials. CONCLUSION: NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.


Assuntos
Neoplasias/tratamento farmacológico , Comitês Consultivos/estatística & dados numéricos , Protocolos Clínicos , Comitês de Ética em Pesquisa/estatística & dados numéricos , Humanos , National Cancer Institute (U.S.)/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Estados Unidos
12.
Vaccine ; 35(23): 3007-3011, 2017 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-28456526

RESUMO

National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive - AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.


Assuntos
Comitês Consultivos , Saúde Global , Política de Saúde , Programas de Imunização/organização & administração , Comitês Consultivos/legislação & jurisprudência , Comitês Consultivos/organização & administração , Comitês Consultivos/estatística & dados numéricos , Congressos como Assunto , França , Humanos , Programas de Imunização/legislação & jurisprudência , Programas de Imunização/estatística & dados numéricos , Programas de Imunização/tendências , Colaboração Intersetorial , Vacinas
13.
Health Econ ; 26(3): 292-304, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-26676999

RESUMO

We provide evidence for the causal impact of social status on longevity by exploiting a natural experiment in which subjects undergo a shift in their social status without considerable economic impact. We gather data on 4190 scientists who were either nominated for or successfully elected to the Chinese Academy of Science or of Engineering. Being elected as an academician in China is a boost in social status (vice-ministerial level) with negligible direct economic impact (US$30 monthly before 2009). After correcting for two sources of bias, (1) some potential academicians decease too young to be elected, leading to selection bias in favor of academicians and (2) the endogenous relationship between health and social status, we find that the enhanced social status of becoming an academician leads to approximately 1.2 years longer life. Copyright © 2015 John Wiley & Sons, Ltd.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Longevidade , Classe Social , Comitês Consultivos/tendências , China , Países em Desenvolvimento , Nível de Saúde , Humanos , Pessoa de Meia-Idade , Política
15.
Epilepsia ; 57(1): 13-23, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26659723

RESUMO

OBJECTIVE: The International League Against Epilepsy (ILAE) Epilepsy Guidelines Task Force, composed of 14 international members, was established in 2011 to identify, using systematic review methodology, international epilepsy clinical care guidelines, assess their quality, and determine gaps in areas of need of development. METHODS: A systematic review of the literature (1985-2014) was performed in six electronic databases (e.g. Medline, Embase) using a broad search strategy without initial limits to language or study design. Six gray literature databases (e.g., American Academy of Neurology [AAN], ILAE) were also searched to minimize publication bias. Two independent reviewers screened abstracts, reviewed full text articles, and performed data abstraction. Descriptive statistics and a meta-analysis were generated. RESULTS: The search identified 10,926 abstracts. Of the 410 articles selected for full text review, 63 met our eligibility criteria for a guideline. Of those included, 54 were in English and 9 were in other languages (French, Spanish, and Italian). Of all guidelines, 29% did not specify the target age groups, 27% were focused on adults, 22% included only children, and 6% specifically addressed issues related to women with epilepsy. Guidelines included in the review were most often aimed at guiding clinical practice for status epilepticus (n = 7), first seizure (n = 6), drug-resistant epilepsy (n = 5), and febrile seizures (n = 4), among others. Most of the guidelines were therapeutic (n = 35) or diagnostic (n = 16) in nature. The quality of the guidelines using a 1-7 point scale (7 = highest) varied and was moderate overall (mean = 4.99 ± 1.05 [SD]). SIGNIFICANCE: We identified substantial gaps in topics (e.g., epilepsy in the elderly) and there was considerable heterogeneity in methodologic quality. The findings should offer a valuable resource for health professionals caring for people with epilepsy, since they will help guide the prioritization, development, and dissemination of future epilepsy-related guidelines.


Assuntos
Epilepsia/terapia , Guias de Prática Clínica como Assunto , Comitês Consultivos/normas , Comitês Consultivos/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Medicina Baseada em Evidências , Humanos , Sociedades Médicas
16.
Epilepsia ; 56(10): 1515-23, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26336950

RESUMO

The Commission on Classification and Terminology and the Commission on Epidemiology of the International League Against Epilepsy (ILAE) have charged a Task Force to revise concepts, definition, and classification of status epilepticus (SE). The proposed new definition of SE is as follows: Status epilepticus is a condition resulting either from the failure of the mechanisms responsible for seizure termination or from the initiation of mechanisms, which lead to abnormally, prolonged seizures (after time point t1 ). It is a condition, which can have long-term consequences (after time point t2 ), including neuronal death, neuronal injury, and alteration of neuronal networks, depending on the type and duration of seizures. This definition is conceptual, with two operational dimensions: the first is the length of the seizure and the time point (t1 ) beyond which the seizure should be regarded as "continuous seizure activity." The second time point (t2 ) is the time of ongoing seizure activity after which there is a risk of long-term consequences. In the case of convulsive (tonic-clonic) SE, both time points (t1 at 5 min and t2 at 30 min) are based on animal experiments and clinical research. This evidence is incomplete, and there is furthermore considerable variation, so these time points should be considered as the best estimates currently available. Data are not yet available for other forms of SE, but as knowledge and understanding increase, time points can be defined for specific forms of SE based on scientific evidence and incorporated into the definition, without changing the underlying concepts. A new diagnostic classification system of SE is proposed, which will provide a framework for clinical diagnosis, investigation, and therapeutic approaches for each patient. There are four axes: (1) semiology; (2) etiology; (3) electroencephalography (EEG) correlates; and (4) age. Axis 1 (semiology) lists different forms of SE divided into those with prominent motor systems, those without prominent motor systems, and currently indeterminate conditions (such as acute confusional states with epileptiform EEG patterns). Axis 2 (etiology) is divided into subcategories of known and unknown causes. Axis 3 (EEG correlates) adopts the latest recommendations by consensus panels to use the following descriptors for the EEG: name of pattern, morphology, location, time-related features, modulation, and effect of intervention. Finally, axis 4 divides age groups into neonatal, infancy, childhood, adolescent and adulthood, and elderly.


Assuntos
Comitês Consultivos , Estado Epiléptico/classificação , Estado Epiléptico/diagnóstico , Comitês Consultivos/estatística & dados numéricos , Eletroencefalografia , História do Século XX , Humanos , Cooperação Internacional , Estado Epiléptico/história , Fatores de Tempo
17.
Nuklearmedizin ; 54(6): 241-6, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26388152

RESUMO

UNLABELLED: The aim was to analyze the degree of agreement between the central review panel and the local PET interpretation within the HD15 trial and its impact on subsequent treatment and progression free survival. PATIENTS, METHODS: The analysis set consisted of 739 patients with residues ≥ 2.5 cm after 6 or 8 cycles of BEACOPPesc from the HD15 trial performed by the German Hodgkin Study Group. The recommendation for or against further radiotherapy was based on the central [(18)F]FDG-PET interpretation. Central PET interpretation was compared to the local PET interpretation and concordance was measured using Cohen's Kappa coefficient. Prognostic impact of the analysis of concordance between local and central PET interpretations was evaluated using progression free survival (PFS); groups were compared with the log rank test. RESULTS: The central panel rated 548 of 739 patients (74%) as PET negative. Of these, 513 were also rated as PET negative in the local PET interpretation. PET positivity was seen by central reviewers in the remaining 191 patients (26%), in concordance with local reviewers in 155 cases. Even though substantial agreement was found (Cohen's Kappa 0.81), the interpretation of the central PET review panel led to a different therapeutic recommendation in 71/739 (10%) patients. PFS was equally high in groups in which the therapeutic regime had been changed on the basis of the central panel decision. CONCLUSION: High concordance is found between local and central reviewers with regard to PET interpretation in residual tissue after intense chemotherapy. The existence of the central PET review panel allows the identification of additional patients as PET negative so that radiotherapy can be safely omitted (35 of 548 patients = 4.7%).


Assuntos
Comitês Consultivos/estatística & dados numéricos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Doença de Hodgkin/diagnóstico por imagem , Doença de Hodgkin/tratamento farmacológico , Interpretação de Imagem Assistida por Computador/métodos , Tomografia por Emissão de Pósitrons/estatística & dados numéricos , Monitoramento de Medicamentos , Europa (Continente)/epidemiologia , Doença de Hodgkin/epidemiologia , Humanos , Variações Dependentes do Observador , Prevalência , Reprodutibilidade dos Testes , Medição de Risco , Sensibilidade e Especificidade , Resultado do Tratamento
18.
Trauma Violence Abuse ; 16(2): 179-87, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24381134

RESUMO

Domestic/Family Violence Death Reviews (D/FVDRs) have been established in a number of high-income countries since 1990 as a mechanism to inform prevention-focused interventions to reduce domestic/family violence. D/FVDRs differ in their structure, governance, case identification processes and inclusion criteria, review measures, and outputs. Outside of the United States, the extent of heterogeneity across and within countries has not been explored. This study comprised an international comparison of D/FVDRs and their core elements to inform the establishment of D/FVDRs in other developed countries, and potentially low- and middle-income countries where violence is a leading cause of death. Such a review is also a necessary foundation for any future evaluation D/FVDRs. The review identified 71 jurisdictions where a D/FVDRs had been established in the past two decades, 25 of which met the inclusion criteria. All D/FVDRs examined stated a reduction in deaths as a goal of the review process; however, none reported an actual reduction. The focus of the D/FVDRs examined was on intimate partner homicides; however, more recently established D/FVDRs include other familial relationships. Almost one third of the D/FVDRs examined reported changes to the domestic/family system that occurred as a result of recommendations made from the review process. While similar in many ways, D/FVDRs differ along a number of important dimensions that make it difficult to identify best practices for jurisdictions considering the establishment of such an initiative. To share knowledge, existing networks should be expanded nationally and internationally to include jurisdictions that may be considering this initiative.


Assuntos
Causas de Morte , Violência Doméstica , Homicídio , Cooperação Internacional , Suicídio , Comitês Consultivos/estatística & dados numéricos , Comparação Transcultural , Países Desenvolvidos/estatística & dados numéricos , Violência Doméstica/economia , Violência Doméstica/prevenção & controle , Violência Doméstica/estatística & dados numéricos , Homicídio/prevenção & controle , Homicídio/estatística & dados numéricos , Humanos , Suicídio/prevenção & controle , Suicídio/estatística & dados numéricos
19.
Milbank Q ; 92(3): 446-70, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25199895

RESUMO

CONTEXT: The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. METHODS: The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior. FINDINGS: Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). CONCLUSIONS: There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.


Assuntos
Comitês Consultivos/organização & administração , Conflito de Interesses , United States Food and Drug Administration/organização & administração , Comitês Consultivos/economia , Comitês Consultivos/estatística & dados numéricos , Aprovação de Drogas/economia , Aprovação de Drogas/organização & administração , Aprovação de Drogas/estatística & dados numéricos , Humanos , Renda , Estados Unidos
20.
Gesundheitswesen ; 76(5): 297-302, 2014 May.
Artigo em Alemão | MEDLINE | ID: mdl-23868650

RESUMO

BACKGROUND: In Germany, medical error reporting systems are well established. They collect information reported principally by physicians. Systematic data collection concerning medical errors is also performed by expert arbitration and advisory boards of the German State Medical Associations. METHODS: Data base MERS (Medical Error Reporting System); cases from the Expert Arbitration and Advisory Board of the State Baden-Württemberg from the years 2004-2011 (8,042 cases) were evaluated as follows: extraction of the cases from general practitioners (n=307, 4%); categorisation of the type of error and degree of severity; classification according to ICD-10 (International Classification of Diseases); overview of confirmed cases including commentaries of the above board; logistic regression analysis of factors potentially associated with confirmed cases. RESULTS: In 26% (n=80) the board confirmed medical errors. 55% of the errors were assigned to the category "diagnosis" (n=44), 21% to "general therapy" (n=17), 8% to "operative therapy" ("minor surgical operations") (n=6) and 10% to "injections" (n=8). 29% of cases (n=23) were associated with permanent damage or death. The majority of cases could be assigned to ICD-10 categories "I" (cardiovascular system, n=20) and "S-T" or "V-Y" (consequences of external causes or external causes of morbidity and mortality, n=34). No significant associations were found by logistic regression analysis. CONCLUSION: The rate of confirmed cases corresponds with the rate of all medical disciplines. The presented overview is illustrative and may be of help to avoid errors by using it for continuing medical education.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Clínicos Gerais/estatística & dados numéricos , Conselho Diretor/estatística & dados numéricos , Notificação de Abuso , Erros Médicos/classificação , Erros Médicos/estatística & dados numéricos , Alemanha , Classificação Internacional de Doenças/estatística & dados numéricos , Negociação
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