Prepartum, childbirth, and immediate puerperium: Nursing diagnoses of mothers of extremely preterm infants.

BACKGROUND: Maternal mortality remains high, despite all the advances and efforts that have occurred in recent years and is directly related to the quality of care provided during pregnancy, childbirth, and in the puerperium. PURPOSE: Identify the possible nursing diagnoses of mothers of newborns admitted to neonatal intensive care in the prepartum period, childbirth, and the puerperium. METHODS: Observational, cross-sectional study carried out by analyzing the medical records of mothers of newborns who required hospitalization in neonatal intensive care and determining the diagnoses through a process of diagnostic inference, based on NANDA-I Taxonomy, during the period from 2007 to 2016. FINDINGS: After reviewing the medical records of 272 mothers, a total of 3,843 observations were identified, distributed in 42 diagnoses, with Excessive fluid volume presenting the greatest predictive power over the outcome variable. The second group of more predictive variables comprised the Risk of vascular trauma, Risk of infection, Impaired parenthood, and Risk of body temperature imbalance. The third group, in turn, consisted of the following diagnoses: Insomnia, Pain during labor, Risk of impaired bonding, Acute pain, and Ineffective Breastfeeding. CONCLUSIONS: The present study enabled the identification of the most frequent NANDA-I nursing diagnoses occurring during the prepartum period, childbirth, and the immediate puerperium of mothers of newborns admitted to neonatal intensive care, as well as those of greatest importance. Based on the encountered diagnoses, it can be concluded that future studies should be carried out in order for validation. IMPLICATIONS: The knowledge of these diagnoses can contribute to the instrumentalization of nursing professionals, with consequent improvements in the nursing process and the provided assistance, aiming to assist in the reduction of maternal morbidity and mortality.

VARIABLES INVOLVED IN THE MANAGEMENT OF SCHOOL BULLYING: A BAYESIAN NETWORK ANALYSIS.

OBJECTIVE: To analyze the management of bullying by the managers of elementary schools. METHODS: Descriptive, exploratory research carried out through semi-structured interviews with 17 school counselors from a city in the South of Brazil, randomly selected from different geographical sectors. The interviews were recorded with participants' consent and, after transcription and checking, were discarded. The interviews covered the following subjects: sociodemographic characterization of subjects, school functioning, comprehension, recognition and management of bullying cases by counselors. Data analysis was performed using the Bayesian network associated with content analysis. RESULTS: The majority of subjects were females, between 30 and 50 years old. Fifteen subjects were graduated in pedagogy, and all had postgraduate degrees. Most of them worked as counselor for less than three years. Only two subjects, between 30 and 50 years old, understood the term bullying. Case recognition was lower in this age group. Having a degree influenced positively the recognition of bullying. The higher the number of students in the school, the lower the recognition of cases by managers. All subjects managed cases by addressing children, families, staff, and involving professionals and support groups. CONCLUSIONS: The understanding and recognition of bullying was given by a few interviewees. All managers reported similar management actions in the cases. Given the scarcity of studies on bullying management in schools, more studies in this area could improve the approach of cases and contribute to their reduction.

Variables involved in the management of school bullying: a bayesian network analysis / Variáveis envolvidas no gerenciamento de conflitos do tipo bullying em escolas: uma análise de rede bayesiana

ABSTRACT Objective: To analyze the management of bullying by the managers of elementary schools. Methods: Descriptive, exploratory research carried out through semi-structured interviews with 17 school counselors from a city in the South of Brazil, randomly selected from different geographical sectors. The interviews were recorded with participants' consent and, after transcription and checking, were discarded. The interviews covered the following subjects: sociodemographic characterization of subjects, school functioning, comprehension, recognition and management of bullying cases by counselors. Data analysis was performed using the Bayesian network associated with content analysis. Results: The majority of subjects were females, between 30 and 50 years old. Fifteen subjects were graduated in pedagogy, and all had postgraduate degrees. Most of them worked as counselor for less than three years. Only two subjects, between 30 and 50 years old, understood the term bullying. Case recognition was lower in this age group. Having a degree influenced positively the recognition of bullying. The higher the number of students in the school, the lower the recognition of cases by managers. All subjects managed cases by addressing children, families, staff, and involving professionals and support groups. Conclusions: The understanding and recognition of bullying was given by a few interviewees. All managers reported similar management actions in the cases. Given the scarcity of studies on bullying management in schools, more studies in this area could improve the approach of cases and contribute to their reduction.

RESUMO Objetivo: Analisar o gerenciamento de conflitos do tipo bullying pelos gestores de escolas de ensino fundamental. Métodos: Pesquisa descritiva e exploratória realizada por meio de entrevistas semiestruturadas com 17 orientadores de escolas escolhidas aleatoriamente de um município do Sul do Brasil, contemplando os diversos setores geográficos locais. As entrevistas foram gravadas mediante consentimento, e, após transcrição e conferência pelos sujeitos, descartadas. As entrevistas abordam: caracterização sociodemográfica dos sujeitos, funcionamento da escola e compreensão, reconhecimento e gerenciamento dos casos de bullying pelos orientadores. A análise dos dados foi feita com base na rede bayesiana associada à análise de conteúdo. Resultados: A maioria dos sujeitos era do sexo feminino e tinha entre 30 e 50 anos. Quinze sujeitos eram formados em pedagogia, e todos possuíam pós-graduação. A maioria atuava na função de orientador havia menos de três anos. A compreensão do termo bullying deu-se apenas por dois sujeitos, com idade entre 30 e 50 anos. Já o reconhecimento dos casos foi menor nessa faixa etária. Ter feito pós-graduação influenciou positivamente o reconhecimento de bullying. Quanto maior o número de alunos na escola, menor o reconhecimento dos casos pelos gestores. Todos os sujeitos gerenciaram os casos abordando as crianças, famílias e equipe e envolvendo profissionais e núcleos de apoio. Conclusões: A compreensão e o reconhecimento do bullying deram-se por poucos entrevistados. Todos os gestores relataram ações de gerenciamento semelhantes diante dos casos. Tendo em vista a escassez de estudos sobre gestão de bullying na escola, mais estudos nessa área poderiam melhorar a abordagem dos casos, contribuindo para sua redução.

Suicide mortality among youth in southern Brazil: a spatiotemporal evaluation of socioeconomic vulnerability

Objective: To conduct a geospatial analysis of suicide deaths among young people in the state of Paraná, southern Brazil, and evaluate their association with socioeconomic and spatial determinants. Methods: Data were obtained from the Mortality Information System and the Brazilian Institute of Geography and Statistics. Data on suicide mortality rates (SMR) were extracted for three age groups (15-19, 20-24, and 25-29 years) from two 5-year periods (1998-2002 and 2008-2012). Geospatial data were analyzed through exploratory spatial data analysis. We applied Bayesian networks algorithms to explore the network structure of the socioeconomic predictors of SMR. Results: We observed spatial dependency in SMR in both periods, revealing geospatial clusters of high SMR. Our results show that socioeconomic deprivation at the municipality level was an important determinant of suicide in the youth population in Paraná, and significantly influenced the formation of high-risk SMR clusters. Conclusion: While youth suicide is multifactorial, there are predictable geospatial and sociodemographic factors associated with high SMR among municipalities in Paraná. Suicide among youth aged 15-29 occurs in geographic clusters which are associated with socioeconomic deprivation. Rural settings with poor infrastructure and development also correlate with increased SMR clusters.

Suicide mortality among youth in southern Brazil: a spatiotemporal evaluation of socioeconomic vulnerability.

OBJECTIVE: To conduct a geospatial analysis of suicide deaths among young people in the state of Paraná, southern Brazil, and evaluate their association with socioeconomic and spatial determinants. METHODS: Data were obtained from the Mortality Information System and the Brazilian Institute of Geography and Statistics. Data on suicide mortality rates (SMR) were extracted for three age groups (15-19, 20-24, and 25-29 years) from two 5-year periods (1998-2002 and 2008-2012). Geospatial data were analyzed through exploratory spatial data analysis. We applied Bayesian networks algorithms to explore the network structure of the socioeconomic predictors of SMR. RESULTS: We observed spatial dependency in SMR in both periods, revealing geospatial clusters of high SMR. Our results show that socioeconomic deprivation at the municipality level was an important determinant of suicide in the youth population in Paraná, and significantly influenced the formation of high-risk SMR clusters. CONCLUSION: While youth suicide is multifactorial, there are predictable geospatial and sociodemographic factors associated with high SMR among municipalities in Paraná. Suicide among youth aged 15-29 occurs in geographic clusters which are associated with socioeconomic deprivation. Rural settings with poor infrastructure and development also correlate with increased SMR clusters.

The distribution of cardiac diagnostic testing for acute coronary syndrome in the Brazilian healthcare system: A national geospatial evaluation of health access.

BACKGROUND: Little is known about the utilization of cardiac diagnostic testing in Brazil and how such testing is related with local rates of acute coronary syndrome (ACS)-related mortality. METHODS AND RESULTS: Using data from DATASUS, the public national healthcare database, absolute counts of diagnostic tests performed were calculated for each of the 5570 municipalities and mapped. Spatial error regression and geographic weighted regression models were used to describe the geographic variation in the association between ACS mortality, income, and access to diagnostic testing. From 2008 to 2014, a total of 4,653,884 cardiac diagnostic procedures were performed in Brazil, at a total cost of $271 million USD. The overall ACS mortality rate during this time period was 133.8 deaths per 100,000 inhabitants aged 20 to 79. The most commonly utilized test was the stress ECG (3,015,993), followed by catheterization (862,627), scintigraphy (669,969) and stress echocardiography (105,295). The majority of these procedures were conducted in large urban centers in more economically developed regions of the country. Increased access to testing and increased income were not uniformly associated with decreased ACS mortality, and tremendous geographic heterogeneity was observed in the relationship between these variables. CONCLUSIONS: The majority of testing for ACS in Brazil is conducted at referral centers in developed urban settings. Stress ECG is the dominant testing modality in use. Increased access to diagnostic testing was not consistently associated with decreased ACS mortality across the country.

Uso racional de antimicrobianos em sepse neonatal / Rational use of antimicrobials in neonatal sepsis

Segundo dados estatísticos divulgados no Sistema de Informações de Mortalidade do DATASUS, 60% da mortalidade infantil ocorrem no período neonatal, sendo a sepse uma das principais causas. O difícil diagnóstico da sepse neonatal e o tratamento inadequado podem aumentar o risco de mortalidade e morbidade nessa população. O diagnóstico de sepse deve ser embasado em parâmetros clínicos e laboratoriais. Os resultados de hemoculturas são utilizados como padrão ouro no diagnóstico de sepse neonatal. Esse estudo abordou a importância do diagnóstico confirmatório pós-uso empírico do antibiótico (ATB) em sepse neonatal presumida. O estudo foi realizado na Unidade Neonatal de uma maternidade de grande porte, com 60 leitos e média mensal de 670 partos, localizada na Região Norte da cidade de São Paulo. Foi coletada informações de 41 prontuários de recém-nascido internados no 1º semestre de 2016, desses 36 eram prematuros (≤ 37 semanas) e 5 eram termos; todos tiveram diagnostico de sepse documentada em prontuário e pela CCIH da instituição. Os resultados demostraram a necessidade de boas praticas do uso racional de antimicrobianos. É necessário promover políticas de prescrição segura e educação continuada nas unidades neonatais.(AU)

Atuação da comissão de farmácia e terapêutica em um hospital de ensino / Performance of the pharmacy and therapeutics committee in ateaching hospital

Introdução: As atividades hospitalares caracterizam-se por um acentuado dinamismo em consequência do surgimento de novas tecnologias em saúde, tais como medicamentos. Uma unidade hospitalar, devido suas características de ensino, pesquisa e atendimentos de alta complexidade, possui maior concentração de diferentes tipos de tecnologias em saúde. O Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto –USP (HCFMRP-USP) é uma instituição hospitalar, de qualidade comprovada, inserido no SUS como referência terciária/quaternária e que conta com a Divisão de Assistência Farmacêutica (DAF) para desenvolvimento das ações de atenção a saúde. A DAF para auxílio da gestão de recursos, seleção e padronização de medicamentos adotou como estratégia a Comissão de Farmácia e Terapêutica (CFT). ACFT é uma instância colegiada, de caráter consultivo e deliberativo, estabelecida pela Organização Mundial de Saúde como ferramenta de estratégia para monitorar e promover a qualidade no uso do medicamento,porém estudos que sobre a atuação das CFTs no Brasil são incipientes. Desta forma, este estudo pretende apresentar a CFT do HCFMRP-USP. Objetivos: apresentar a composição, atribuições e metodologia de trabalho da CFT, bem como desenvolver uma análise crítica de seu atual funcionamento. Metodologia:Foi realizado estudo descritivo e exploratório com o objetivo de descrever o atual funcionamento da CFT do HCFMRP-USP. Foram buscadas portarias, regulamentações internas e foi realizada revisão bibliográfica sobre a CFT. Para Análise crítica do atual funcionamento, foi selecionado dentre os itens padronizados pela comissão aquele que se enquadrasse como pertencente a classificação A e V, após o cruzamento das curvas ABC e VEN, cujo item selecionado foi o medicamento Sevoflurano...

Introduction: The hospital activities are characterized by a highly dynamism as a result of new health technologies such as medicines. A hospital due its characteristics of teaching, research and high complexity care, has the highest concentration of different types of health technologies. The Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto – USP (HCFMRP-USP) is a hospital, with proven quality, inserted in the SUS as a tertiary/quaternary referral and has the Pharmaceutical Services Division (DAF) for development of actions of health care. To aid resource management, selection and standardization of drugs, DAF adopted the strategy of Pharmacy and Therapeutics Committee (CFT). The CFT is a collegial, consultative and deliberative body, established by the World Health Organization as a strategy tool to monitor and promote the quality in the use of medicine, but studies of CFTs are incipient in Brazil. Thus, this study aims to present the CFT of HCFMRP–USP. Objectives: To introduce the composition, responsibilities and working methods of CFT, as well as a critical analysis of its current operation. Methods: A descriptive study aimed to describe the current functioning of the CFT of HCFMRP-USP was performed. Ordinances, internal regulations were surveyed and a bibliographic review of the CFT was performed. To the critical analysis ofthe current operating, was selected by the committee from the standard one that would fit classification asbelonging to “A” and “V” items after the crossing of the curves ABC and VEN, whose selected item was the medicine Sevoflurane...

System dynamics modeling in the evaluation of delays of care in ST-segment elevation myocardial infarction patients within a tiered health system.

BACKGROUND: Mortality rates amongst ST segment elevation myocardial infarction (STEMI) patients remain high, especially in developing countries. The aim of this study was to evaluate the factors related with delays in the treatment of STEMI patients to support a strategic plan toward structural and personnel modifications in a primary hospital aligning its process with international guidelines. METHODS AND FINDINGS: The study was conducted in a primary hospital localized in Foz do Iguaçu, Brazil. We utilized a qualitative and quantitative integrated analysis including on-site observations, interviews, medical records analysis, Qualitative Comparative Analysis (QCA) and System Dynamics Modeling (SD). Main cause of delays were categorized into three themes: a) professional, b) equipment and c) transportation logistics. QCA analysis confirmed four main stages of delay to STEMI patient's care in relation to the 'Door-in-Door-out' time at the primary hospital. These stages and their average delays in minutes were: a) First Medical Contact (From Door-In to the first contact with the nurse and/or physician): 7 minutes; b) Electrocardiogram acquisition and review by a physician: 28 minutes; c) ECG transmission and Percutaneous Coronary Intervention Center team feedback time: 76 minutes; and d) Patient's Transfer Waiting Time: 78 minutes. SD baseline model confirmed the system's behavior with all occurring delays and the need of improvements. Moreover, after model validation and sensitivity analysis, results suggested that an overall improvement of 40% to 50% in each of these identified stages would reduce the delay. CONCLUSIONS: This evaluation suggests that investment in health personnel training, diminution of bureaucracy, and management of guidelines might lead to important improvements decreasing the delay of STEMI patients' care. In addition, this work provides evidence that SD modeling may highlight areas where health system managers can implement and evaluate the necessary changes in order to improve the process of care.

Brazilian road traffic fatalities: a spatial and environmental analysis.

BACKGROUND: Road traffic injuries (RTI) are a major public health epidemic killing thousands of people daily. Low and middle-income countries, such as Brazil, have the highest annual rates of road traffic fatalities. In order to improve road safety, this study mapped road traffic fatalities on a Brazilian highway to determine the main environmental factors affecting road traffic fatalities. METHODS AND FINDINGS: Four techniques were utilized to identify and analyze RTI hotspots. We used spatial analysis by points by applying kernel density estimator, and wavelet analysis to identify the main hot regions. Additionally, built environment analysis, and principal component analysis were conducted to verify patterns contributing to crash occurrence in the hotspots. Between 2007 and 2009, 379 crashes were notified, with 466 fatalities on BR277. Higher incidence of crashes occurred on sections of highway with double lanes (ratio 2∶1). The hotspot analysis demonstrated that both the eastern and western regions had higher incidences of crashes when compared to the central region. Through the built environment analysis, we have identified five different patterns, demonstrating that specific environmental characteristics are associated with different types of fatal crashes. Patterns 2 and 4 are constituted mainly by predominantly urban characteristics and have frequent fatal pedestrian crashes. Patterns 1, 3 and 5 display mainly rural characteristics and have higher prevalence of vehicular collisions. In the built environment analysis, the variables length of road in urban area, limited lighting, double lanes roadways, and less auxiliary lanes were associated with a higher incidence of fatal crashes. CONCLUSIONS: By combining different techniques of analyses, we have identified numerous hotspots and environmental characteristics, which governmental or regulatory agencies could make use to plan strategies to reduce RTI and support life-saving policies.

Surgical treatment of sleep apnea: association between surgeon/hospital volume with outcomes.

OBJECTIVES/HYPOTHESIS: To identify the association between surgeon/hospital volume with outcomes in surgical treatment for obstructive sleep apnea (OSA) in a nationally representative sample. We hypothesized that surgeons/hospitals with lower patient volumes would have: higher mortality rates, longer hospital length of stay (LOS), and higher postoperative complication rates and hospitalization charges. STUDY DESIGN: Secondary data analysis of the 2007 Nationwide Inpatient Sample database. METHODS: We selected 24,298 adults undergoing OSA surgery. The data analysis included trend test, regression, and multivariate models that were adjusted by demographic and clinical variables. RESULTS: The patients were mostly White (76.43%), male (78.26%), with a mean age of 46 years. Patients treated by surgeons with low volume of procedures (1 procedure/year) had significantly higher mortality rate (odds ratio [OR] 3.05; confidence interval [CI], 1.96-4.77), longer average LOS (increased until 8.16 hours), and higher hospitalization charges (increased up to $1701.75) versus medium- and high-volume surgeons (2-4 procedures/year; greater than/or equal to 5 procedures/year, respectively). Patients treated at hospitals with low volume of procedures (0-5/year) had significantly higher occurrence of oxygen desaturation (OR, 2.12; CI, 1.50-2.99), longer LOS (increased until almost 2 hours) and higher hospitalization charges (at least $951.50 more expensive) versus patients treated at high-volume hospitals (greater than/or equal to 18 procedures/year). CONCLUSION: Our investigation validates the hypothesis that lower volume standards (surgeon/hospital) are associated with increase of LOS following surgery to treat OSA, as well as lower surgeon volume associated with increase of mortality and hospitalization charges and lower hospital volume with occurrence of oxygen desaturation as postoperative complication.

Concomitant vascular reconstruction during pancreatectomy for malignant disease: a propensity score-adjusted, population-based trend analysis involving 10,206 patients.

OBJECTIVE: To assess trends in the frequency of concomitant vascular reconstructions (VRs) from 2000 through 2009 among patients who underwent pancreatectomy, as well as to compare the short-term outcomes between patients who underwent pancreatic resection with and without VR. DESIGN: Single-center series have been conducted to evaluate the short-term and long-term outcomes of VR during pancreatic resection. However, its effectiveness from a population-based perspective is still unknown. Unadjusted, multivariable, and propensity score-adjusted generalized linear models were performed. SETTING: Nationwide Inpatient Sample from 2000 through 2009. PATIENTS: A total of 10,206 patients were involved. MAIN OUTCOME MEASURES: Incidence of VR during pancreatic resection, perioperative in-hospital complications, and length of hospital stay. RESULTS: Overall, 10,206 patients were included in this analysis. Of these, 412 patients (4.0%) underwent VR, with the rate increasing from 0.7% in 2000 to 6.0% in 2009 (P < .001). Patients who underwent pancreatic resection with VR were at a higher risk for intraoperative (propensity score-adjusted odds ratio, 1.94; P = .001) and postoperative (propensity score-adjusted odds ratio, 1.36; P = .008) complications, while the mortality and median length of hospital stay were similar to those of patients without VR. Among the 25% of hospitals with the highest surgical volume, patients who underwent pancreatic surgery with VR had significantly higher rates of postoperative complications and mortality than patients without VR. CONCLUSIONS: The frequency of VR during pancreatic surgery is increasing in the United States. In contrast with most single-center analyses, this population-based study demonstrated that patients who underwent VR during pancreatic surgery had higher rates of adverse postoperative outcomes than their counterparts who underwent pancreatic resection only. Prospective studies incorporating long-term outcomes are warranted to further define which patients benefit from VR.

Regional disparities in mortality after ischemic heart disease in a Brazilian state from 2006 to 2010.

BACKGROUND: High technology in the field of interventional cardiology applied in tertiary hospitals has brought enormous benefits in the treatment of ischemic heart disease (IHD). However, IHD mortality rates remain high. We analyzed the relationship between IHD mortality rate and the socioeconomic, demographic, and geographic conditions in 399 cities in Parana state, Brazil, from 2006 to 2010. METHODS AND RESULTS: Data were obtained from the Mortality Information System and the Brazilian Institute of Geography and Statistics and evaluated through Exploratory Spatial Data Analysis. GeoDa™ was used to analyze 29.351 deaths across 399 cities. We found a positive spatial autocorrelation regarding IHD mortality (I = 0.5913, p = 0.001). There was a significant positive association between each of three socioeconomic and demographic indicators and IHD mortality rate: Population Elderly Index (I = 0.3436), Illiteracy Rate (I = 0.1873) and City Development Index (I = 0.0900). In addition, two indicators presented significant negative association with IHD mortality rate: Adjusted Population Size (I = -0.1216) and Gross Domestic Product (I = -0.0864). We also found a positive association between IHD mortality rates and the geographic distances between patients' city of residence and their corresponding regional referral centers in interventional cardiology (I = 0.3368). Cities located within Regional Health Units with Reference Interventional Cardiology Center presented a significantly lower average specific mortality rate by IHD. The high mortality rate by IHD within the Regional Health Units was not restricted to socioeconomic and demographic variables, but dependent on the distance between each city and their reference interventional cardiology center. CONCLUSIONS: We conclude that geographic factors play a significant role in IHD mortality within cities. These findings have important policy implications regarding the geographic distribution of cardiac health care networks in Latin America and in other emerging countries.

High risks for adverse outcomes after gastric bypass surgery following failed gastric banding: a population-based trend analysis of the United States.

OBJECTIVES: The objectives of this investigation were to (1) compare short-term outcomes for patients undergoing primary gastric bypass surgery with those who had gastric bypass procedures performed as a rescue procedure after failed gastric banding and (2) study trends in the frequency of reoperations between 2005 and 2008 for patients who had prior gastric banding. BACKGROUND: The use of gastric banding to treat obesity has increased drastically in the United States. However, the frequency of reoperations related to gastric banding and associated short-term outcomes are unknown. METHODS: The Nationwide Inpatient Sample from 2005 to 2008 was used for this population-based study. Descriptive statistics as well as unadjusted and risk-adjusted generalized linear models were performed to assess adverse short-term outcomes. RESULTS: A total of 66,303 patients were included in the analysis, 63,171 (95.3%) underwent a primary gastric bypass procedure and 3132 patients (4.7%) underwent a gastric band-related reoperation. Patients undergoing a gastric bypass procedure concomitant with a band-related reoperation had more intraoperative complications [risk-adjusted odds ratio (OR): 2.3, P = 0.002] and postoperative complications (risk-adjusted OR: 8.0, P < 0.001), were at higher risk of reoperations/reinterventions (risk-adjusted OR: 6.0, P < 0.001), increased length of hospital stay (adjusted mean difference: 0.89 days, P < 0.001), and higher hospital charges (adjusted mean difference: $13,257, P < 0.001). The number of gastric band-related reoperations increased from 579 in 2005 to 1132 in 2008 (196%). CONCLUSIONS: The number of reoperations after gastric banding is rapidly increasing in the United States. To our knowledge, this is the first population-based study providing strong evidence that patients undergoing gastric bypass procedure after failed gastric banding have more adverse outcomes than those undergoing gastric bypass alone. The broad indication for gastric banding should be reaffirmed for the US population.

Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

BACKGROUND: With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. METHODOLOGY/PRINCIPAL FINDINGS: Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. CONCLUSIONS/SIGNIFICANCE: Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial sponsors should improve relevant support systems.

Standardizing clinical trials workflow representation in UML for international site comparison.

BACKGROUND: With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. METHODS: Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. RESULTS: Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. CONCLUSIONS: This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials workflows.

WriteSim TCExam--an open source text simulation environment for training novice researchers in scientific writing.

BACKGROUND: The ability to write clearly and effectively is of central importance to the scientific enterprise. Encouraged by the success of simulation environments in other biomedical sciences, we developed WriteSim TCExam, an open-source, Web-based, textual simulation environment for teaching effective writing techniques to novice researchers. We shortlisted and modified an existing open source application - TCExam to serve as a textual simulation environment. After testing usability internally in our team, we conducted formal field usability studies with novice researchers. These were followed by formal surveys with researchers fitting the role of administrators and users (novice researchers) RESULTS: The development process was guided by feedback from usability tests within our research team. Online surveys and formal studies, involving members of the Research on Research group and selected novice researchers, show that the application is user-friendly. Additionally it has been used to train 25 novice researchers in scientific writing to date and has generated encouraging results. CONCLUSION: WriteSim TCExam is the first Web-based, open-source textual simulation environment designed to complement traditional scientific writing instruction. While initial reviews by students and educators have been positive, a formal study is needed to measure its benefits in comparison to standard instructional methods.

Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets.

BACKGROUND: Sharing of epidemiological and clinical data sets among researchers is poor at best, in detriment of science and community at large. The purpose of this paper is therefore to (1) describe a novel Web application designed to share information on study data sets focusing on epidemiological clinical research in a collaborative environment and (2) create a policy model placing this collaborative environment into the current scientific social context. METHODOLOGY: The Database of Databases application was developed based on feedback from epidemiologists and clinical researchers requiring a Web-based platform that would allow for sharing of information about epidemiological and clinical study data sets in a collaborative environment. This platform should ensure that researchers can modify the information. A Model-based predictions of number of publications and funding resulting from combinations of different policy implementation strategies (for metadata and data sharing) were generated using System Dynamics modeling. PRINCIPAL FINDINGS: The application allows researchers to easily upload information about clinical study data sets, which is searchable and modifiable by other users in a wiki environment. All modifications are filtered by the database principal investigator in order to maintain quality control. The application has been extensively tested and currently contains 130 clinical study data sets from the United States, Australia, China and Singapore. Model results indicated that any policy implementation would be better than the current strategy, that metadata sharing is better than data-sharing, and that combined policies achieve the best results in terms of publications. CONCLUSIONS: Based on our empirical observations and resulting model, the social network environment surrounding the application can assist epidemiologists and clinical researchers contribute and search for metadata in a collaborative environment, thus potentially facilitating collaboration efforts among research communities distributed around the globe.

A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research.

BACKGROUND: Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. METHODS: Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. RESULTS: A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. CONCLUSIONS: Future studies should explore ways of creating mechanisms which decrease the time and cost associated with standardisation processes. In addition, the fact that the costs and time necessary for data standards implementation decrease with time should be made known to the wider research community. Policy makers should attempt to match their data standardisation policies better with the expectations of researchers.

Implementação do diagnóstico de enfermagem na unidade de terapia intensiva e os dificultadores para enfermagem ? relato de experiência / Implementation of the nursing diagnosis at the unit of intensive therapy and the problems in nursing practice - report based on personal experience / Implementación del diagnóstico de enfermaje en la unidad de terapia intensiva y sus obstáculos ? relato de una vivencia

A sistematização da assistência de enfermagem é uma atividade de incumbência privativa do enfermeiro, tendo como metas a organização, planejamento, implementação, execução e avaliação do processo de enfermagem. Tendo em vista a importância do processo de enfermagem, objetivou-se descrever a implementação do diagnóstico de enfermagem numa unidade de terapia intensiva, relatar o aprendizado teórico-prático dos enfermeiros acerca do diagnóstico e identificar os dificultadores que interferiram na sua implementação. Para tanto, as etapas seqüenciais da implementação do diagnóstico foram descritas conforme foram vivenciadas pelos profissionais. Participaram da experiência oito enfermeiros atuantes na referida unidade. O trabalho teve início em maio de 2003 sendo definido em agosto de 2004, quando foram implementados o diagnóstico e os novos impressos de enfermagem. As dificuldades vivenciadas na implementação do diagnóstico foram: adequação à rotina da unidade, tempo disponível do enfermeiro para a execução das etapas do processo, impressos indisponíveis, resistência do enfermeiro à utilização e desvalorização do método. Apesar dos obstáculos, os resultados dessa prática demonstraram a viabilidade da execução do processo de enfermagem, visando melhor qualidade na assistência prestada ao ser humano e conseqüente crescimento profissional, valorização e autonomia à enfermagem.

The nursing assistance systematization is an activity of privative incumbency of the nurse, having as goals organization, planning, implementation, execution and evaluation of the nursing process. In view of the importance of the nursing process, it was objectified to describe the implementation of the nursing diagnosis in an unit of intensive therapy; to give an account of the theoretical and practical learning of the nurses about the diagnosis and to identify the factors that caused difficulties and had interfered in its implementation. The sequential stages of the implementation of the diagnosis were described as they were lived by the professionals. In such a way, it was adopted the descriptive method according to the sequential stages of the implementation of the diagnosis. The subjects of this study were eight nurses that work in the related unit. The labor was initiated in May of 2003, being defined in August of 2004, when the diagnosis and the new printed nursing check-lists were implemented. The difficulties experienced in the implementation of the diagnosis were: to adjust to the unit routine, the nurses´ available time to execute the stages of the process, unavailable printed check-lists, nurses´ resistance to use the process and not to value the method. Although the obstacles, the results of this practice showed the viability of the nursing process execution, aiming a better quality in the assistance given to the human being and consequent professional growth, valuation and autonomy to the nursing.

La sistematización de la asistencia del enfermería es una actividad de incumbencia exclusiva del enfermero, teniendo como metas la organización, la planificación, implementación, ejecución y evaluación de este proceso. Teniendo en cuenta la importancia de dicho proceso, se busco describir la implementación del diagnóstico de enfermería en una unidad de terapia intensiva, relatar el aprendizaje teórico-práctico de los enfermeros a respecto del diagnóstico y identificar los obstáculos que interfirieran en su implementación. Por lo tanto, las etapas secuenciales de la implementación del diagnóstico fueron descritas de acuerdo con lo vivido por los profesionales. Los sujetos de este estudio fueron ocho enfermeros actuantes en la referida unidad. El trabajo tuvo inicio en mayo de 2003 siendo definido en agosto de 2004, cuando fueron implementados el diagnóstico y los nuevos impresos de enfermería. Las dificultades ocurridas en la implementación del diagnóstico fueron: adecuación a la rutina de la unidad, tiempo disponible del enfermero para la ejecución de las etapas del proceso, impresos indisponibles, resistencia del enfermero a la utilización y la no valoración del método. Aunque los obstáculos hayan existido, los resultados de esa práctica demostraron la viabilidad de la ejecución del proceso de enfermería, visando mejorar la calidad de la asistencia prestada al ser humano y consecuente desarrollo profesional, valorización y autonomía.