Fatores associados à qualidade de registros de acidentes de trabalho no Sistema de Informações sobre Mortalidade no Brasil / Factors associated with quality of work accident records in Brazil's Mortality Information System / Factores asociados a la calidad de registros de accidentes de trabajo en el Sistema de Informaciones sobre Mortalidad en Brasil

Resumo: Este estudo teve como objetivo identificar fatores associados à qualidade do registro de acidentes de trabalho fatais no Sistema de Informações sobre Mortalidade (SIM), ocorridos com pessoas de 18 a 65 anos, entre 1998 e 2013, no Brasil. A qualidade do registro da possível relação causal de acidentes com o trabalho <acidtrab>, campo existente em declarações de óbitos, exclusivo para acidentes dentre as causas externas, foi analisada com duas variáveis: (1) registro "ignorado" (R-IGN, sim/não); (2) registros ausentes ou inconsistentes (R-AUS, sim/não). Foram encontrados 665.531 óbitos dentre os quais 67,7% dos registros de <acidtrab> eram de má qualidade. Fatores associados a registro "ignorado" foram: sexo masculino; cor da pele branca; escolaridade menor que a superior; não operários ou não agricultores; atestante Instituto Médico Legal (IML); regiões Sudeste e Nordeste; e óbito em hospital. Registros ausentes ou inconsistentes se associaram: à idade acima de 34 anos; à cor da pele não branca; a sem escolaridade; a todas as regiões, exceto à Sudeste; a óbito em hospital ou no domicílio; a boletim de ocorrência como fonte; e a atestante IML. Esses fatores, independentemente associados à má qualidade de preenchimento do campo <acidtrab>, compreendiam dimensões individuais, da fonte de emissão, do local do óbito e geográficas. Isso revela a necessidade de melhoria da qualidade de declarações de óbito em hospitais, IML e boletins de ocorrência, treinando e supervisionando equipes em todo o Brasil.

Abstract: This study aimed to identify factors associated with the quality of fatal work accident records in the Brazilian Mortality Information System in individuals 18 to 65 years of age from 1998 to 2013. The quality of the record of possible causal relationship between accidents and the work <acidtrab>, a field that appears on death certificates and is exclusive to accidents among external causes, was analyzed with two variables: (1) record "ignored" (R-IGN, yes/no); (2) missing or inconsistent records (R-AUS, yes/no). A total of 665,531 deaths were located, of which 67.7% of the <acidtrab> records showed poor quality. Factors associated with record "ignored" were: male sex; white skin color; schooling less than university; non-blue-collar workers or non-farmers; death certificate issued by the Forensic Medical Office (IML); Southeast and Northeast regions of the country; and death in hospital. Missing or inconsistent records were associated with: age greater than 34 years; non-white skin color; no schooling; all regions of Brazil except the Southeast; death in hospital or at home; police report as the source of information; and death certificate issued by the IML. The factors independently associated with poor quality of completion of the field <acidtrab> included individual dimensions, source issuing the death certificate, place of death, and geographic variables. The findings reveal the need to improve the quality of death records in hospitals, the IML, and police reports, besides training and supervising teams throughout Brazil.

Resumen: El objetivo de este estudio fue identificar factores asociados a la calidad del registro de accidentes de trabajo fatales en el Sistema de Información sobre Mortalidad (SIM), ocurridos con personas de 18 a 65 años, entre 1998 y 2013, en Brasil. La calidad del registro de la posible relación causal de accidentes con el trabajo <acidtrab>, campo existente en las declaraciones de fallecimiento, exclusivo para accidentes entre las causas externas, se analizó con dos variables: (1) registro "ignorado" (R-IGN, sí/no); (2) registros ausentes o inconsistentes (R-AUS, sí/no). Se encontraron 665.531 óbitos entre los cuales un 67,7% de los registros de <acidtrab> eran de mala calidad. Los factores asociados al registro "ignorado" fueron: sexo masculino; color de piel blanco; escolaridad menor que la superior; no obreros o no agricultores; con atestado del Instituto Médico Legal (IML); región sudeste y nordeste; y fallecimiento en hospital. Los registros ausentes o inconsistentes se asociaron a: edad por encima de 34 años; color de piel no blanca; sin escolaridad; todas las regiones, excepto la sudeste; fallecimiento en hospital o en el domicilio; boletín de ocurrencia como fuente; y con atestado IML. Estos factores independientemente asociados a la mala calidad en la cumplimentación del campo <acidtrab> incluían dimensiones individuales, de la fuente de emisión, del lugar del fallecimiento y geográficas. Esto revela la necesidad de mejora en la calidad de las declaraciones de óbito en hospitales, IML y boletines de ocurrencia, entrenando y supervisando equipos en todo Brasil.

Improving the timeliness and accuracy of injury severity data in road traffic accidents in an emerging economy setting.

Road traffic injuries (RTIs) are among the leading causes of injury and fatality worldwide. RTI casualties are continually increasing in Taiwan; however, because of a lack of an advanced method for classifying RTI severity data, as well as the fragmentation of data sources, road traffic safety and health agencies encounter difficulties in analyzing RTIs and their burden on the healthcare system and national resources. These difficulties lead to blind spots during policy-making for RTI prevention and control. After compiling classifications applied in various countries, we summarized data sources for RTI severity in Taiwan, through which we identified data fragmentation. Accordingly, we proposed a practical classification for RTI severity, as well as a feasible model for collecting and integrating these data nationwide. This model can provide timely relevant data recorded by medical professionals and is valuable to healthcare providers. The proposed model's pros and cons are also compared to those of other current models.

[Factors associated with quality of work accident records in Brazil's Mortality Information System]. / Fatores associados à qualidade de registros de acidentes de trabalho no Sistema de Informações sobre Mortalidade no Brasil.

This study aimed to identify factors associated with the quality of fatal work accident records in the Brazilian Mortality Information System in individuals 18 to 65 years of age from 1998 to 2013. The quality of the record of possible causal relationship between accidents and the work , a field that appears on death certificates and is exclusive to accidents among external causes, was analyzed with two variables: (1) record "ignored" (R-IGN, yes/no); (2) missing or inconsistent records (R-AUS, yes/no). A total of 665,531 deaths were located, of which 67.7% of the records showed poor quality. Factors associated with record "ignored" were: male sex; white skin color; schooling less than university; non-blue-collar workers or non-farmers; death certificate issued by the Forensic Medical Office (IML); Southeast and Northeast regions of the country; and death in hospital. Missing or inconsistent records were associated with: age greater than 34 years; non-white skin color; no schooling; all regions of Brazil except the Southeast; death in hospital or at home; police report as the source of information; and death certificate issued by the IML. The factors independently associated with poor quality of completion of the field included individual dimensions, source issuing the death certificate, place of death, and geographic variables. The findings reveal the need to improve the quality of death records in hospitals, the IML, and police reports, besides training and supervising teams throughout Brazil.

Este estudo teve como objetivo identificar fatores associados à qualidade do registro de acidentes de trabalho fatais no Sistema de Informações sobre Mortalidade (SIM), ocorridos com pessoas de 18 a 65 anos, entre 1998 e 2013, no Brasil. A qualidade do registro da possível relação causal de acidentes com o trabalho , campo existente em declarações de óbitos, exclusivo para acidentes dentre as causas externas, foi analisada com duas variáveis: (1) registro "ignorado" (R-IGN, sim/não); (2) registros ausentes ou inconsistentes (R-AUS, sim/não). Foram encontrados 665.531 óbitos dentre os quais 67,7% dos registros de eram de má qualidade. Fatores associados a registro "ignorado" foram: sexo masculino; cor da pele branca; escolaridade menor que a superior; não operários ou não agricultores; atestante Instituto Médico Legal (IML); regiões Sudeste e Nordeste; e óbito em hospital. Registros ausentes ou inconsistentes se associaram: à idade acima de 34 anos; à cor da pele não branca; a sem escolaridade; a todas as regiões, exceto à Sudeste; a óbito em hospital ou no domicílio; a boletim de ocorrência como fonte; e a atestante IML. Esses fatores, independentemente associados à má qualidade de preenchimento do campo , compreendiam dimensões individuais, da fonte de emissão, do local do óbito e geográficas. Isso revela a necessidade de melhoria da qualidade de declarações de óbito em hospitais, IML e boletins de ocorrência, treinando e supervisionando equipes em todo o Brasil.

El objetivo de este estudio fue identificar factores asociados a la calidad del registro de accidentes de trabajo fatales en el Sistema de Información sobre Mortalidad (SIM), ocurridos con personas de 18 a 65 años, entre 1998 y 2013, en Brasil. La calidad del registro de la posible relación causal de accidentes con el trabajo , campo existente en las declaraciones de fallecimiento, exclusivo para accidentes entre las causas externas, se analizó con dos variables: (1) registro "ignorado" (R-IGN, sí/no); (2) registros ausentes o inconsistentes (R-AUS, sí/no). Se encontraron 665.531 óbitos entre los cuales un 67,7% de los registros de eran de mala calidad. Los factores asociados al registro "ignorado" fueron: sexo masculino; color de piel blanco; escolaridad menor que la superior; no obreros o no agricultores; con atestado del Instituto Médico Legal (IML); región sudeste y nordeste; y fallecimiento en hospital. Los registros ausentes o inconsistentes se asociaron a: edad por encima de 34 años; color de piel no blanca; sin escolaridad; todas las regiones, excepto la sudeste; fallecimiento en hospital o en el domicilio; boletín de ocurrencia como fuente; y con atestado IML. Estos factores independientemente asociados a la mala calidad en la cumplimentación del campo incluían dimensiones individuales, de la fuente de emisión, del lugar del fallecimiento y geográficas. Esto revela la necesidad de mejora en la calidad de las declaraciones de óbito en hospitales, IML y boletines de ocurrencia, entrenando y supervisando equipos en todo Brasil.

Evidence for national universal eye health plans.

Many low- and middle-income countries use national eye-care plans to guide efforts to strengthen eye-care services. The World Health Organization recognizes that evidence is essential to inform these plans. We assessed how evidence was incorporated in a sample of 28 national eye-care plans generated since the Universal eye health: a global action plan 2014-2019 was endorsed by the World Health Assembly in 2013. Most countries (26, 93%) cited estimates of the prevalence of blindness and 18 countries (64%) had set targets for the cataract surgical rate in their plan. Other evidence was rarely cited or used to set measurable targets. No country cited evidence from systematic reviews or solution-based research. This limited use of evidence reflects its low availability, but also highlights incomplete use of existing evidence. For example, despite sex-disaggregated data and cataract surgical coverage being available from surveys in 20 countries (71%), these data were reported in the eye health plans of only nine countries (32%). Only three countries established sex-disaggregated indicators and only one country had set a target for cataract surgical coverage for future monitoring. Countries almost universally recognized the need to strengthen health information systems and almost one-third planned to undertake operational or intervention research. Realistic strategies need to be identified and supported to translate these intentions into action. To gain insights into how a country can strengthen its evidence-informed approach to eye-care planning, we reflect on the process underway to develop Kenya's seventh national plan (2019-2023).

De nombreux pays à revenu faible et intermédiaire ont recours à des plans nationaux de santé oculaire pour guider les actions visant à renforcer les services d'ophtalmologie. L'Organisation mondiale de la Santé reconnaît qu'il est essentiel de disposer de données factuelles pour orienter ces plans. Nous avons évalué la manière dont ces données factuelles ont été intégrées à un échantillon de 28 plans nationaux de santé oculaire, élaborés depuis l'adoption par l'Assemblée Mondiale de la Santé, en 2013, du document Santé oculaire universelle: plan d'action mondial 2014­2019. La plupart des pays (26, soit 93%) ont indiqué utiliser des estimations de la prévalence de la cécité et 18 pays (64%) avaient fixé des objectifs relatifs au taux de chirurgie de la cataracte dans leur plan. D'autres types de données factuelles ont rarement été mentionnés ou utilisés pour définir des objectifs mesurables. Aucun pays n'a mentionné de données issues de revues systématiques ou de recherches fondées sur des solutions. Cette utilisation limitée des données factuelles reflète leur faible accessibilité, mais aussi l'usage incomplet des données existantes. Par exemple, bien que des enquêtes menées dans 20 pays (71%) donnent accès à des données ventilées par sexe et au taux de couverture de la chirurgie de la cataracte, seuls neuf pays (32%) ont reporté ces données dans leur plan de santé oculaire. Seuls trois pays ont mis en place des indicateurs ventilés par sexe et un seul a défini un objectif de couverture de la chirurgie de la cataracte pour en suivre l'évolution. La quasi-totalité des pays a reconnu qu'il était nécessaire de renforcer les systèmes d'information sanitaire et près d'un tiers prévoyait d'entreprendre des recherches opérationnelles ou interventionnelles. Il faudra définir et mettre en œuvre des stratégies réalistes pour passer de l'intention à l'action. Pour en savoir plus sur la manière dont un pays peut renforcer son approche d'élaboration de plans de santé oculaire à partir de données factuelles, nous nous intéressons à l'élaboration, en cours, du septième plan national du Kenya (2019­2023).

Muchos países con ingresos entre bajos y medios utilizan planes nacionales de atención oftalmológica para orientar los esfuerzos a fortalecer los servicios de atención oftalmológica. La Organización Mundial de la Salud reconoce que las pruebas son esenciales para informar a estos planes. Se evaluó cómo se incorporaron las pruebas en una muestra de 28 planes nacionales de atención oftalmológica generados desde que la Asamblea Mundial de la Salud aprobó Universal eye health: a global action plan 2014­2019 (Atención oftalmológica universal: un plan de acción mundial para 2014-2019) en 2013. La mayoría de los países (26, 93 %) citaron estimaciones de la prevalencia de la ceguera y 18 países (64 %) habían establecido metas para la tasa quirúrgica de cataratas en sus planes. Rara vez se citaron o utilizaron otras pruebas para establecer objetivos mensurables. Ningún país citó pruebas de revisiones sistemáticas o investigaciones basadas en soluciones. Este uso limitado de las pruebas refleja su baja disponibilidad, pero también destaca el uso incompleto de las pruebas existentes. Por ejemplo, a pesar de que los datos desglosados por sexo y la cobertura quirúrgica de cataratas están disponibles en las encuestas de 20 países (71 %), estos datos solo se reflejaron en los planes de atención oftalmológica de nueve países (32 %). Solo tres países establecieron indicadores desglosados por sexo y solo un país había establecido una meta para la cobertura quirúrgica de cataratas para el seguimiento futuro. Los países reconocieron casi universalmente la necesidad de fortalecer los sistemas de información sanitaria y casi un tercio tenía previsto realizar investigaciones operacionales o de intervención. Es necesario identificar y apoyar estrategias realistas para convertir estas intenciones en acciones. Para comprender mejor cómo un país puede fortalecer su enfoque basado en pruebas para la planificación de la atención oftalmológica, se ha analizado el proceso en curso para desarrollar el séptimo plan nacional en Kenia (2019-2023).

[Application of classified protection of information security in the information system of air pollution and health impact monitoring].

OBJECTIVE: To study the application of classified protection of information security in the information system of air pollution and health impact monitoring, so as to solve the possible safety risk of the information system. METHODS: According to the relevant national standards and requirements for the information system security classified protection, and the professional characteristics of the information system, to design and implement the security architecture of information system, also to determine the protection level of information system. RESULTS: Basic security measures for the information system were developed in the technical safety and management safety aspects according to the protection levels, which effectively prevented the security risk of the information system. CONCLUSION: The information system established relatively complete information security protection measures, to enhanced the security of professional information and system service, and to ensure the safety of air pollution and health impact monitoring project carried out smoothly.

Transformation of Arden Syntax's medical logic modules into ArdenML for a business rules management system.

INTRODUCTION: Arden Syntax is a Health Level Seven International (HL7) standard language that is used for representing medical knowledge as logic statements. Arden Syntax Markup Language (ArdenML) is a new representation of Arden Syntax based on XML. Compilers are required to execute medical logic modules (MLMs) in the hospital environment. However, ArdenML may also replace the compiler. The purpose of this study is to demonstrate that MLMs, encoded in ArdenML, can be transformed into a commercial rule engine format through an XSLT stylesheet and made executable in a target system. METHODS: The target rule engine selected was Blaze Advisor. We developed an XSLT stylesheet to transform MLMs in ArdenML into Structured Rules Language (SRL) in Blaze Advisor, through a comparison of syntax between the two languages. The stylesheet was then refined recursively, by building and applying rules collected from the billing and coding guidelines of the Korean health insurance service. Two nurse coders collected and verified the rules and two information technology (IT) specialists encoded the MLMs and built the XSLT stylesheet. Finally, the stylesheet was validated by importing the MLMs into Blaze Advisor and applying them to claims data. RESULTS: The language comparison revealed that Blaze Advisor requires the declaration of variables with explicit types. We used both integer and real numbers for numeric types in ArdenML. "IF∼THEN" statements and assignment statements in ArdenML become rules in Blaze Advisor. We designed an XSLT stylesheet to solve this issue. In addition, we maintained the order of rule execution in the transformed rules, and added two small programs to support variable declarations and action statements. A total of 1489 rules were reviewed during this study, of which 324 rules were collected. We removed duplicate rules and encoded 241 unique MLMs in ArdenML, which were successfully transformed into SRL and imported to Blaze Advisor via the XSLT stylesheet. When applied to 73,841 outpatients' insurance claims data, the review result was the same as that of the legacy system. CONCLUSION: We have demonstrated that ArdenML can replace a compiler for transforming MLMs into commercial rule engine format. While the proposed XSLT stylesheet requires refinement for general use, we anticipate that the development of further XSLT stylesheets will support various rule engines.

ICT and the future of healthcare: Aspects of pervasive health monitoring.

Along with the digital revolution, information and communication technology applications are currently transforming the delivery of health and social care services. This paper investigates prevailing opinions toward future technology-based healthcare solutions among Austrian healthcare professionals. During a biphasic online Delphi survey, panelists rated expected outcomes of two future scenarios describing pervasive health monitoring applications. Experts perceived that the scenarios were highly innovative, but only moderately desirable, and that their implementation could especially improve patients' knowledge, quality of healthcare, and living standard. Contrarily, monetary aspects, technical prerequisites, and data security were identified as key obstacles. We further compared the impact of professional affiliation. Clearly, opinions toward pervasive healthcare differed between the interest groups, medical professionals, patient advocates, and administrative personnel. These data suggest closer collaborations between stakeholder groups to harmonize differences in expectations regarding pervasive health monitoring.

An Assessment of Information Exchange Practices, Challenges, and Opportunities to Support US Disease Surveillance in 3 States.

BACKGROUND: State and local public health agencies collect and use surveillance data to identify outbreaks, track cases, investigate causes, and implement measures to protect the public's health through various surveillance systems and data exchange practices. PURPOSE: The purpose of this assessment was to better understand current practices at state and local public health agencies for collecting, managing, processing, reporting, and exchanging notifiable disease surveillance information. METHODS: Over an 18-month period (January 2014-June 2015), we evaluated the process of data exchange between surveillance systems, reporting burdens, and challenges within 3 states (California, Idaho, and Massachusetts) that were using 3 different reporting systems. RESULTS: All 3 states use a combination of paper-based and electronic information systems for managing and exchanging data on reportable conditions within the state. The flow of data from local jurisdictions to the state health departments varies considerably. When state and local information systems are not interoperable, manual duplicative data entry and other work-arounds are often required. The results of the assessment show the complexity of disease reporting at the state and local levels and the multiple systems, processes, and resources engaged in preparing, processing, and transmitting data that limit interoperability and decrease efficiency. CONCLUSIONS: Through this structured assessment, the Centers for Disease Control and Prevention (CDC) has a better understanding of the complexities for surveillance of using commercial off-the-shelf data systems (California and Massachusetts), and CDC-developed National Electronic Disease Surveillance System Base System. More efficient data exchange and use of data will help facilitate interoperability between National Notifiable Diseases Surveillance Systems.

State-Level Immunization Information Systems: Potential for Childhood Immunization Data Linkages.

Objectives Sources of immunization data include state registries or immunization information systems (IIS), medical records, and surveys. Little is known about the quality of these data sources or the feasibility of using IIS data for research. We assessed the feasibility of collecting immunization information for a national children's health study by accessing existing IIS data and comparing the completeness of these data against medical record abstractions (MRA) and parent report. Staff time needed to obtain IIS and MRA data was assessed. Methods We administered a questionnaire to state-level IIS representatives to ascertain availability and completeness of their data for research and gather information about data formats. We evaluated quality of data from IIS, medical records, and reports from parents of 119 National Children's Study participants at three locations. Results IIS data were comparable to MRA data and both were more complete than parental report. Agreement between IIS and MRA data was greater than between parental report and MRA, suggesting IIS and MRA are better sources than parental report. Obtaining IIS data took less staff time than chart review, making IIS data linkage for research a preferred choice. Conclusions IIS survey results indicate data can be obtained by researchers using data linkages. IIS are an accessible and feasible child immunization information source and these registries reduce reliance on parental report or medical record abstraction. Researchers seeking to link IIS data with large multi-site studies should consider acquiring IIS data, but may need strategies to overcome barriers to data completeness and linkage.

Software Quality Evaluation Models Applicable in Health Information and Communications Technologies. A Review of the Literature.

Information and Communications Technologies in healthcare has increased the need to consider quality criteria through standardised processes. The aim of this study was to analyse the software quality evaluation models applicable to healthcare from the perspective of ICT-purchasers. Through a systematic literature review with the keywords software, product, quality, evaluation and health, we selected and analysed 20 original research papers published from 2005-2016 in health science and technology databases. The results showed four main topics: non-ISO models, software quality evaluation models based on ISO/IEC standards, studies analysing software quality evaluation models, and studies analysing ISO standards for software quality evaluation. The models provide cost-efficiency criteria for specific software, and improve use outcomes. The ISO/IEC25000 standard is shown as the most suitable for evaluating the quality of ICTs for healthcare use from the perspective of institutional acquisition.

The experience of educational quality in undergraduate nursing students: a phenomenological study.

AIM: The evaluation of academic education has become crucial in the European Union since the Bologna Process encouraged all European universities to reach high quality standards in education. Although several studies have been conducted on the quality of undergraduate nursing education, few studies have explored this topic from the students' perspective. The purpose of this study was to describe the experience of educational quality in undergraduate nursing students. METHOD: The phenomenological method was used to study 55 students (mean age 24 years; 73% female) pursuing a baccalaureate degree in nursing in three universities in central Italy. RESULTS: The following five themes emerged from the phenomenological analysis: 1) quality of faculties: teaching skills, preparation, sensitivity to students, self-discipline; 2) theory-practice integration and communication between teaching and clinical area; 3) general management and organization of the programme; 4) quality of infrastructures: libraries, classrooms, information technology, services, administration, and communication; and 5) clinical tutorship: humanity, relationships and ability of the clinical tutor to guide and support. CONCLUSION: This study's novel finding was a deeper understanding of the educational quality's meanings among undergraduate nursing students. Students thought educational quality consisted of the faculty members' sensitivity towards their problems and the clinical tutors' humanity, interpersonal skills, guidance and support.

Filling the gap between disaster preparedness and response networks of urban emergency management: Following the 2013 Seoul Floods.

OBJECTIVE: To examine the gap between disaster preparedness and response networks following the 2013 Seoul Floods in which the rapid transmission of disaster information and resources was impeded by severe changes of interorganizational collaboration networks. DESIGN/SETTING/METHODOLOGY/APPROACH: This research uses the 2013 Seoul Emergency Management Survey data that were collected before and after the floods, and total 94 organizations involving in coping with the floods were analyzed in bootstrap independent-sample t-test and social network analysis through UCINET 6 and STATA 12. RESULTS: The findings show that despite the primary network form that is more hierarchical, horizontal collaboration has been relatively invigorated in actual response. Also, interorganizational collaboration networks for response operations seem to be more flexible grounded on improvisation to coping with unexpected victims and damages. CONCLUSIONS: Local organizations under urban emergency management are recommended to tightly build a strong commitment for joint response operations through full-size exercises at the metropolitan level before a catastrophic event. Also, interorganizational emergency management networks need to be restructured by reflecting the actual response networks to reduce collaboration risk during a disaster. ORIGINALITY/INNOVATIONS: This research presents a critical insight into inverse thinking of the view designing urban emergency management networks and provides original evidences for filling the gap between previously coordinated networks for disaster preparedness and practical response operations after a disaster.

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard.

mHealth in Low- and Middle-Income Countries: Status, Requirements and Strategies.

Recent studies demonstrate the potential of Mobile Health (mHealth) to improve quality of care and efficiency in low- and middle- income countries (LMIC). However, strong evidence of their impact, especially in large scale projects is still missing. The objective of this paper is to provide an overview about the current status of mHealth in LMIC, and to identify Requirements and possible Strategies to strength their health systems. A search in Pubmed was performed, which resulted in 427 articles. Restricting the search to review papers published during the last 5 years, 72 publications were identified and characterized, and the more relevant articles analyzing mHealth use, impact and/or adoption in LMIC from a more generic perspective were analyzed in detail. Finally, based on the literature, and complemented with the authors own reflections and experience, mHealth challenges and strategies were identified and presented according to the WHO Health Systems Framework which identifies six main lines of action to improve the performance of health systems: service delivery, health workforce, health information systems, essential medical products and technologies, health financing and governance.

Development and assessment of floor and ceiling items for the PROMIS physical function item bank.

INTRODUCTION: Disability and Physical Function (PF) outcome assessment has had limited ability to measure functional status at the floor (very poor functional abilities) or the ceiling (very high functional abilities). We sought to identify, develop and evaluate new floor and ceiling items to enable broader and more precise assessment of PF outcomes for the NIH Patient-Reported-Outcomes Measurement Information System (PROMIS). METHODS: We conducted two cross-sectional studies using NIH PROMIS item improvement protocols with expert review, participant survey and focus group methods. In Study 1, respondents with low PF abilities evaluated new floor items, and those with high PF abilities evaluated new ceiling items for clarity, importance and relevance. In Study 2, we compared difficulty ratings of new floor items by low functioning respondents and ceiling items by high functioning respondents to reference PROMIS PF-10 items. We used frequencies, percentages, means and standard deviations to analyze the data. RESULTS: In Study 1, low (n = 84) and high (n = 90) functioning respondents were mostly White, women, 70 years old, with some college, and disability scores of 0.62 and 0.30. More than 90% of the 31 new floor and 31 new ceiling items were rated as clear, important and relevant, leaving 26 ceiling and 30 floor items for Study 2. Low (n = 246) and high (n = 637) functioning Study 2 respondents were mostly White, women, 70 years old, with some college, and Health Assessment Questionnaire (HAQ) scores of 1.62 and 0.003. Compared to difficulty ratings of reference items, ceiling items were rated to be 10% more to greater than 40% more difficult to do, and floor items were rated to be about 12% to nearly 90% less difficult to do. CONCLUSIONS: These new floor and ceiling items considerably extend the measurable range of physical function at either extreme. They will help improve instrument performance in populations with broad functional ranges and those concentrated at one or the other extreme ends of functioning. Optimal use of these new items will be assisted by computerized adaptive testing (CAT), reducing questionnaire burden and insuring item administration to appropriate individuals.

[Horus: technological innovation in pharmaceutical assistance within the Brazilian unified health system]. / Hórus: inovação tecnológica na assistência farmacêutica no sistema único de saúde.

OBJECTIVE: To analyze results of the Horus Information System, comparing elements of this system with some international experiences. METHODS: Horus is a technological innovation introduced in 2009 in the Pharmaceutical management information system of the Sistema Único de Saúde (Brazilian Unified Health System). In 2011, local managers and health professionals of 1,247 municipalities (16 states) that adhered to Horus answered questionnaires on pharmaceutical assistance in primary care and about the Horus system. This is a descriptive and exploratory study, developed with the use of quantitative and qualitative methods of research. Multivariate tools were used for data collection and interpretative support of the statistical inference and thematic analysis. RESULTS: The main changes identified after the implementation of this system were: improvement on technical and scientific quality control of Pharmaceutical Assistance, improvement on the supply of medications and health care; training of human resources and knowledge management; improvement on the relationship health managers/users; development in the administrative management and greater inter-state management; and improvement on the technological infrastructure. In terms of health information systems, these categories are consistent with programs and obstacles observed in international experiences. The biggest gap identified was the fact that Horus was not included in a national policy of health information systems, which is in a process of consolidation in Brazil. The national database of actions and services within the Pharmaceutical Assistance will enable the collection, analysis and dissemination of information regarding integrated pharmaceutical assistance in the Brazilian context. CONCLUSIONS: The Horus System is a technological innovation that enables the management of the Pharmaceutical Assistance. The national base will enable the definition and agreement on national indicators of Pharmaceutical Assistance, aiming to produce evidence of better health conditions to the users and produce indications about the situation of the National Policy on Pharmaceutical Assistance and its trends.