Protocolo del Sistema Nacional de Vigilancia Epidemiológica, SINAVE. No. 01 / Protocol of the National Epidemiological Surveillance System, SINAVE. No. 01

El documento es una presentación del Manual de Normas y Procedimientos del Sistema Nacional de Vigilancia Epidemiológica (SINAVE), que incluye 13 documentos, iniciando con este que explica la estructura del Sistema de Vigilancia y el resto que aborda alguno de los aspectos epidemiológicos que se han estudiado con el objeto de conocer tendencia, evolución, e identificación de regiones geográficas afectadas y los grupos poblacionales vulnerables, así como el conocimiento del estado de salud de la población e identificación precoz de los brotes para su intervención inmediata y control. En el documento, se afirma que: La vigilancia epidemiológica, permite llevar a cabo un estudio minucioso de los brotes y enfermedades que pueden afectar al país, brindando la base para poder orientar las políticas de salud en la prevención, reducción de la morbilidad y mortalidad por causas prevenibles a través de la recolección y el análisis del flujo de información con evidencia científica, interpretación y difusión de los datos sustentados. Además que, el desarrollo del manual, se basa en la necesidad de contar con un SINAVE único, actualizado y estandarizado. Y enfatiza que, su propósito, es servir de guía para la obtención de información y conocimientos epidemiológicos relevantes sobre riesgos y daños a la salud, a través del desarrollo y fortalecimiento del Sistema Nacional de Vigilancia Epidemiológica (SINAVE), con la finalidad de coadyuvar a las acciones de prevención y protección de la salud, definidas por el Ministerio de Salud en sus políticas, prioridades y normativa.

Establishing research priorities in prevention and control of vector-borne diseases in urban areas: a collaborative process.

BACKGROUND: In 2015, following a call for proposals from the Special Programme for Research and Training in Tropical Diseases (TDR), six scoping reviews on the prevention and control of vector-borne diseases in urban areas were conducted. Those reviews provided a clear picture of the available knowledge and highlighted knowledge gaps, as well as needs and opportunities for future research. Based on the research findings of the scoping reviews, a concept mapping exercise was undertaken to produce a list of priority research needs to be addressed. METHODS: Members of the six research teams responsible for the "VEctor boRne DiseAses Scoping reviews" (VERDAS) consortium's scoping reviews met for 2 days with decision-makers from Colombia, Brazil, Peru, Pan-American Health Organization, and World Health Organization. A total of 11 researchers and seven decision-makers (from ministries of health, city and regional vector control departments, and vector control programs) completed the concept mapping, answering the question: "In view of the knowledge synthesis and your own expertise, what do we still need to know about vector-borne diseases and other infectious diseases of poverty in urban areas?" Participants rated each statement on two scales from 1 to 5, one relative to 'priority' and the other to 'policy relevance', and grouped statements into clusters based on their own individual criteria and expertise. RESULTS: The final map consisted of 12 clusters. Participants considered those entitled "Equity", "Technology", and "Surveillance" to have the highest priority. The cluster considered the most important concerns equity issues, confirming that these issues are rarely addressed in research on vector-borne diseases. On the other hand, the "Population mobility" and "Collaboration" clusters were considered to be the lowest priority but remained identified by participants as research priorities. The average policy relevance scores for each of the 12 clusters were roughly the same as the priority scores for all clusters. Some issues were not addressed during the brain-storming. This is the case for governance and for access and quality of care. CONCLUSIONS: Based on this work, and adopting a participatory approach, the concept mapping exercise conducted collaboratively with researchers from these teams and high-level decision-makers identified research themes for which studies should be carried out as a priority.

Chronic disease as risk multiplier for disadvantage.

This paper starts by establishing a prima facie case that disadvantaged groups or individuals are more likely to get a chronic disease and are in a disadvantaged position to adhere to chronic treatment despite access through Universal Health Coverage. However, the main aim of this paper is to explore the normative implications of this claim by examining two different but intertwined argumentative lines that might contribute to a better understanding of the ethical challenges faced by chronic disease health policy. The paper develops the argument that certain disadvantages which may predispose to illness might overlap with disadvantages that may hinder self-management, potentially becoming disadvantageous in handling chronic disease. If so, chronic diseases may be seen as disadvantages in themselves, describing a reproduction of disadvantage among the chronically ill and a vicious circle of disadvantage that could both predict and shed light on the catastrophic health outcomes among disadvantaged groups-or individuals-dealing with chronic disease.

[Healthcare research in forensic commitment or poking around in the dark : Consensus paper on the necessity for more uniform and better data]. / Versorgungsforschung im Maßregelvollzug oder das Stochern im Nebel : Konsenspapier zur Notwendigkeit einheitlicher und besserer Daten.

Complex trends in occupancy determined by many influencing factors, clear state-specific differences in imprisonment practices as well as recently implemented statutory alterations to the appropriate paragraphs in criminal law, underline the necessity for qualitative high-grade concomitant research of German forensic commitment; however, neither the structural prerequisites nor an adequate data situation are currently present in order to do justification to this aim. Not even the total number of patients currently accommodated in forensic commitment can be elucidated from the publicized (partial) statistics. This consensus paper, which was formulated by three research institutes active at the state level, describes the limited possibilities for current forensic healthcare research and raises the demand for a nationwide uniform data situation on patients in forensic commitment. Furthermore, how the appropriate elicitation instrument should be organizationally and structurally achieved, is sketched from a scientific perspective. This article aims at initiating a discussion on a sustainable improvement in the prerequisites for healthcare research in German forensic commitment and targets a sensitization of decision makers in politics and administration for this topic.

[An approach to research in the political agendas of the health sector in Colombia between 1990 and 2010]. / Una aproximación a la investigación en las agendas políticas del sector salud en Colombia entre 1990 y 2010.

OBJECTIVE: To understand health research in Colombia in the context of governmental and legislative agendas related to the health sector between 1990 and 2010. METHODS: Official sources were used such as development plans, bills and institutional documents. RESULTS: The National Government, the Ministry of Health and Social Protection (MSPS by its acronym in Spanish) and the Colombian Congress have focused their attention on health research as a public concern at certain presidential periods due to their interest in reducing the gap between research and health needs. In the 1990s, government plans showed greater interest in formulating a Science and Technology (S&T) policy in health led by the Ministry, an entity that had directorates, commissions and committees responsible for promoting and planning health research. In Congress, some health system reform projects included initiatives to formulate a health research policy that were not approved. DISCUSSION: Health research is recognized as a fundamental tool to help solve health problems. However, said recognition by governmental and legislative actors has not been constant and the institutionality in the health sector has been precarious considering that there is no permanent interest in formulating an S&T policy in health.

OBJETIVO: Entender la investigación en salud en Colombia como parte de agendas gubernamentales y legislativas relacionadas con el sector salud entre 1990 y 2010. MÉTODOS: Se usaron fuentes documentales oficiales como planes de desarrollo, proyectos de ley y otras publicaciones institucionales. RESULTADOS: El Gobierno Nacional, el Ministerio de Salud y Protección Social (MSPS) y el Congreso colombiano han puesto la atención a la investigación en salud como un problema público en diferentes periodos presidenciales debido al interés de reducir la brecha entre la investigación y las necesidades en salud. En los planes gubernamentales durante los años noventa se presentó mayor interés en la formulación de una política de Ciencia y Tecnología (CyT) en salud liderado por el MSPS, entidad que contaba con direcciones, comisiones y comités encargados de promover y planear la investigación en salud. En el Congreso, algunos proyectos de reforma al sistema de salud incluyeron iniciativas para formular una política de investigación en salud que no fueron aprobadas. DISCUSIÓN: La investigación en salud es reconocida como fundamental para contribuir a solucionar los problemas de salud. Sin embargo, este reconocimiento no ha sido constante por parte de los actores gubernamentales y legislativos, la institucionalidad en el sector salud ha sido precaria y no hubo insistente interés por formular una política de CyT en salud.

Freedom of Information Act: scalpel or just a sharp knife?

The concluding statement of the Burns Commission, established to evaluate whether changes are needed to the Freedom of Information Act (FOIA), ruled no major legislative changes were required. As such Freedom of Information (FOI) legislation still enables anyone to obtain information from public authorities. In this brief report article we explore arguments regarding FOI as an instrument for healthcare research using an international research programme as a case study.

Health Systems Research in a Complex and Rapidly Changing Context: Ethical Implications of Major Health Systems Change at Scale.

This paper discusses health policy and systems research in complex and rapidly changing contexts. It focuses on ethical issues at stake for researchers working with government policy makers to provide evidence to inform major health systems change at scale, particularly when the dynamic nature of the context and ongoing challenges to the health system can result in unpredictable outcomes. We focus on situations where 'country ownership' of HSR is relatively well established and where there is significant involvement of local researchers and close ties and relationships with policy makers are often present. We frame our discussion around two country case studies with which we are familiar, namely China and South Africa and discuss the implications for conducting 'embedded' research. We suggest that reflexivity is an important concept for health system researchers who need to think carefully about positionality and their normative stance and to use such reflection to ensure that they can negotiate to retain autonomy, whilst also contributing evidence for health system change. A research process informed by the notion of reflexive practice and iterative learning will require a longitudinal review at key points in the research timeline. Such review should include the convening of a deliberative process and should involve a range of stakeholders, including those most likely to be affected by the intended and unintended consequences of change.

[On health research as public policy in Colombia: assessment and perspectives]. / Investigación en salud como política pública en Colombia: balance y perspectivas.

This essay presents some elements of analysis for thinking about health research in Colombia as a public policy, something which was formed starting in 1990 with the establishment of Science and Technology regulations. A set of institutional adjustments was carried out which led to the creation of the National Program of Health Science and Technology and the National Council of Health Science and Technology. In addition, it led to the institutionalization of calls for research proposals as a mechanism for selecting research projects and assigning resources in accordance with the needs and priorities of the National System of Science and Technology. Since then, there have been no major changes in the public management of health research, with the exception of the Health Research Fund, created in 2001. However, some efforts have been made to develop some capacities and -so far unsuccessfully- to formulate a national policy on health research. The Statutory Health Act approved in 2015 could be an important opportunity to realize and implement this policy decision.

Journalists, district attorneys and researchers: why IRBs should get in the middle.

BACKGROUND: Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public. DISCUSSION: Using two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public's interest in transparency, the researcher's interest in their science, and the research participants' interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis. SUMMARY: For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.

[Nothing about us without us: health care research with people with intellectual disabilities]. / Niet zonder ons: onderzoek mét mensen met verstandelijke beperkingen.

While the patients' perspective has been included in health care research, the participation of people with intellectual disabilities in research on their health has been limited, and considered to be difficult. However, they are vulnerable and experience more health problems than the general population. Legal issues regarding inclusion of people with intellectual disabilities are clarified in international and Dutch law, and should be respected. Aside from the legally responsible persons, various other stakeholders also play a role, which should be realized and considered when developing research plans. Inclusion of people with intellectual disabilities themselves in research, not only as subjects but also as advisors, researchers and decision-makers could make research more relevant and attractive for themselves, for health practice and for the research community.

[Analysis of public quality reports for home care and long-term care with respect to their usefulness for the customer]. / Analyse der ambulanten und stationären Pflegenoten hinsichtlich der Nützlichkeit für den Verbraucher.

BACKGROUND: Public quality reports, based on new legislative regulations of 2008, were supposed to offer potential customers the possibility to make a well-informed choice of a care provider. AIM: This empirical study on marks for long-term care is based on the public quality reports of the Medical Service of the Health Insurance Companies (MDK), of 11 884 home care services and 10 310 nursing homes, which corresponds to a comprehensive survey of almost all care providers in Germany. METHOD: Descriptive statistical methods and discussion of the results concerning the customer benefit. RESULTS: The analysis of transparency reports reveals a limited value for customers, which is particularly caused by very good quality results with low scattering. In addition, a high amount of missing data - especially in the area of home care providers - leads to a growing influence of service criteria on the final grade. Though deficits in nursing might be compensated by good marks in service criteria, it rarely occurs. At present, a more detailed look at risk criteria hardly improves the customer benefit. CONCLUSION: The marks for nursing need to be improved to increase their informative value for the customer.

How policy makers can smooth the way for communication-and- resolution programs.

Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees' experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants' fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers' financial recourse following medical error).