Globally, health research organizations are called upon to re-examine their policies and practices to more efficiently and effectively address current scientific and social needs, as well as increasing public demands for accountability.Through a case study approach, the authors examine an effort undertaken by the National Institute of Allergy & Infectious Diseases  to develop an evaluation system for its recently restructured HIV/AIDS clinical trials program. The challenges in designing, operationalizing, and managing global clinical trials programs are considered in the context of large scale scientific research initiatives.Through a process of extensive stakeholder input, a framework of success factors was developed that enables both a prospective view of the elements that must be addressed in an evaluation of this research and a current state assessment of the extent to which the goals of the restructuring are understood by stakeholders across the DAIDS clinical research networks. These practical concerns are sparking interest in research research .This manuscript describes the process and progress to date in developing a systematic approach to support the evaluation of a global human immunodeficiency virus (HIV) clinical trials research program. Further, it analyzes and draws inferences from this specific work that may have broad applicability for the management, operationalization, and evaluation of other large-scale research endeavors.The specific case study highlighted here is situated in the recent restructure of the world's largest human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) clinical trials program. We begin by reviewing the program's context, its scientific goals and objectives, rationale for the restructure, and how the factors that drove the restructure were addressed in the restructuring plan. We then focus on the development of a conceptual framework as the foundation of a larger evaluation system, emphasizing the process and results of a stakeholder-driven effort to describe the success factors for the newly restructured program. We discuss the resulting framework in the context of the program's goals and its implications for the evaluation of other large scale research endeavors.In recent years, there has been a broad transformation of the organization and management of science in the United States ,3. In adOne major type of "big science" is clinical research networks of which the HIV/AIDS clinical networks described in this manuscript are a prominent example. There are nearly 300 clinical research networks in the United States and Canada. The majority are funded primarily by the US Government and nearly half carry out clinical trials as their primary activity . Non-triAnother type of "big science" is the extramural research center structure, first funded in the 1960s. There are now more than 1200 center programs, with each of the National Institutes of Health (NIH) institutes using this approach [Large research initiatives generally have broader goals than traditional individual investigator-initiated grants . In addiThus, the multiplicity of goals and stakeholder agendas which these research enterprises simultaneously pursue, poses substantial management, implementation and evaluation challenges. At the same time, there are growing pressures for accountability for federally funded scientific research -11, and Leading scientific bodies, responding to government expectations, have issued their own recommendations for the evaluation of scientific research endeavors ,14-16. TThe Division of Acquired Immunodeficiency Syndrome (DAIDS) is one of three extramural scientific divisions of the National Institute for Allergy and Infectious Diseases (NIAID), the second largest of the 27 institutes and centers that comprise the U.S. National Institutes of Health (NIH). Established in 1986, the mission of DAIDS is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), supporting the development of therapies for HIV infection and its complications and co-infections, and supporting the development of vaccines and other prevention strategies. With an annual budget of approximately one billion dollars, DAIDS is a major source of funding for biomedical research around the world.Beginning with the AIDS Treatment Evaluation Units in 1987, DAIDS goal in establishing the HIV/AIDS networks was to assemble multidisciplinary scientific expertise, and create sustainable, reusable capacity and infrastructure to support a long-term commitment to clinical trials. The ensuing 19 years witnessed significant scientific advances as well as major changes in the global demographics of HIV/AIDS, presenting both challenges and opportunities for research. In response, the DAIDS networks have evolved and adapted. An overview of the history and evolution of the DAIDS networks is shown in Figure In 2001, several factors, including the size and complexity of the network enterprise, changes in the HIV/AIDS knowledge base, unabated expansion of the epidemic in the developing world, and fiscal considerations, prompted the DAIDS leadership to reexamine the organizational and funding structure of the networks. Taking into account these and other factors, the Division began working with investigators, collaborators, advisory committees, community groups, and a wide range of stakeholders to help develop the scientific priorities going forward, and gather input on how best to restructure the clinical trials programs in anticipation of a grant competition in 2005. Six scientific priority areas for HIV/AIDS clinical trials research emerged from this effort:• HIV Vaccine Research & Development• Translational Research for Therapeutic Development• Optimization of Clinical Management• Microbicide Research & Development• Mother-to-Child Transmission of HIV• Prevention ResearchFurther, the following key guiding principles were identified:Maintain a flexible and responsive approach to emerging research challenges that ensures that the highest research priorities are addressedImprove efficiency through the shared use of key support services , common data elements and harmonized data systems, coordinated specimen management, shared/standardized training for common needs, coordinated clinical product acquisition, distribution and provision.Harmonize and/or integrate HIV/AIDS prevention, vaccine and therapeutic research at the scientific and community levels, in order to maximize research opportunities and better respond to public health needsBuild and strengthen HIV/AIDS research capacity, especially in resource-limited settings, both domestically and internationallyStrengthen evaluation of network science and management to help ensure that the networks address the highest priority research questions, and function as efficiently and effectively as possible through the identification and implementation of best practices, and linking funding to performance.To put these scientific and operational priorities into place, DAIDS developed and issued two "Request for Application" (RFAs) that differed substantially from previous network solicitations in several ways.1. Whereas in the past DAIDS issued multiple "dedicated" RFAs , this time a single Leadership Group RFA was used. Competition through a single RFA highlighted the importance of the linkages between the scientific priorities, the applicability of the guiding principles to all applicant networks, and the decision not to set a pre-determined funding level for any one (or group) of the six scientific area(s).2. Similarly, a single RFA was used to solicit applications for Clinical Trials Units (CTU) seeking funds to carry out the future network trials. In previous funding cycles, DAIDS had issued RFAs for CTU that were 'specific' to a particular network. The rationale behind the single CTU RFA was to maximize scientific opportunity and efficiency by allowing investigators (including those in resource poor settings) interested in participating in more than one type of clinical trial (e.g. vaccines and treatments) to describe their capabilities, and how they would coordinate and harmonize this research, within a single application. This approach also supports DAIDS goal to help build HIV/AIDS clinical research capacity by making grant awards directly to institutions in areas where the disease has hit the hardest, and where resources are often constrained.3. To stimulate the implementation of a cross-cutting and interdisciplinary research agenda, both RFAs described four key organizational elements/activities: 1) a new committee comprised of the Principal Investigators of the networks; 2) a new central office of HIV/AIDS network coordination; and 3) a new Community Partners group, to enhance community input on all levels, and assure effective representation of (and timely communication among) the many communities,  within which the networks conduct research, and; 4) coordination, communication and collaboration across the Institutes and Centers at NIH that co-sponsor or, in other ways, contribute the HIV/AIDS clinical research networks.4. To help address the likely scenario of emergent high priority research opportunities that could require timely reordering of scientific priorities, new flexible resource allocations were developed. Both RFAs described the importance of performance evaluation, designation of new 'reserve' funds, and a role for external advisory bodies to assist in meeting such challenges.In June 2006, NIAID announced funding for the restructured HIV/AIDS clinical trials networks:• AIDS Clinical Trials Group • HIV Prevention Trials Network • HIV Vaccine Trials Network • International Maternal Pediatric Adolescent AIDS Clinical Trials • International Network for Strategic Initiatives in Global HIV Trials • Microbicide Trials Network Together, including the network leadership groups and 73 CTU located around the world, funding for the networks was approximately $285 million in the first year of awards.within a single Network, such as the clinical trials units, laboratories, data management centers, scientific and resource committees, and protocol teams. In some instances, ad hoc expert review panels have provided external input and evaluative information. While such single network-focused evaluation activities remain very important, DAIDS also recognizes the need for a cross-cutting evaluation framework that can support the common guiding principles that span the restructured network enterprise . Such a system can assist DAIDS, its investigators and collaborators in ensuring that the highest priority scientific objectives are addressed; while supporting collaboration, efficiency and research integration at the cross-network level. While the approach being developed is designed to build upon and complement existing within-network evaluation approaches, it will also define criteria and measures that should be applicable across the networks. It will address a variety of factors required for the success of clinical research networks, including activities and processes based within (as well as across) the investigator networks, constituency communities, collaborators (e.g. support contractors), and DAIDS itself .DAIDS considers a comprehensive, integrated evaluation system a vital element of the new coordinated network structure. Prior to restructuring (and currently), evaluation activities have been almost exclusively 'network centric'. Each group's investigator leadership has primary responsibility for developing and implementing criteria and processes for assessing the structural components The DAIDS HIV/AIDS clinical trials networks are an example of a large scale scientific initiative and as such, share much in common with similar ventures, including broad goals, a multidisciplinary focus, and emphasis on team science. However, the HIV/AIDS clinical trials networks are unique due to aspects related specifically to the conduct of international human clinical research, namely: 1) the reliance on inter-institutional collaboration among multiple clinical research centers and other collaborators ; 2) interaction with research constituents/advocates, including vulnerable populations, and related ethical issues; 3) compliance with regulatory authorities of multiple countries which frequently are not harmonized; 4) the need to maintain a consistent and yet humanitarian distinction between research and care; 5) achieving balance between competing clinical research priorities . Ultimately, DAIDS seeks to support the goals of the clinical research networks, individually and collectively, toward research progress against HIV/AIDS.While most program evaluations are ad hoc, this effort is unique in that it focuses on creating a system of evaluation. The development of an evaluation system for the DAIDS clinical research networks encompasses several integrated phases. Figure There are numerous challenges in developing appropriate evaluation systems for large research initiatives. These include: ensuring the highest-quality evidence; minimizing burden and the intrusiveness of the system; and yielding data that can satisfy a myriad of scientific, managerial, financial, and regulatory requirements. One of the most challenging aspects is identifying the goals of a complex research initiative across a wide array of stakeholders, each with a set of expectations as to what constitutes success. There are few precedents to guide evaluation planning for such efforts. With the expectation that today's scientific research enterprise is collaborative and coordinated at multiple levels, several sources of input are needed to define the goals of these complex and diverse systems, develop strategies to work across disciplines in new and innovative ways, and evaluate the outcomes of collaborative work. Due to the broad range of activities, potential outputs, and outcomes of large research initiatives, it is essential that a comprehensive conceptual model to serve as guide for evaluation is developed . DespiteMany of the challenges found in evaluating scientific research initiatives can be mitigated by engaging the stakeholders of the system, particularly those not often involved in determining organizational evaluation elements, in the process of evaluation planning. In this section, we describe the approach to engaging stakeholders in the construction of the conceptual framework to guide the development of an evaluation system for the DAIDS clinical research program.To construct the evaluation framework in an informed way, the engagement of a diverse array of stakeholders was deemed necessary. The project sought input from those who will ultimately be involved in implementing the evaluation, including DAIDS staff, Network investigator leadership, the HIV/AIDS Office of Network Coordination, network evaluation coordinators, community advisory board representatives, and other government agency staff with a role in the networks. Our goal was to achieve a broad sampling of ideas rather than a representative sampling of persons. Thus, the approach was purposive, sampling for heterogeneity. The focus on broad heterogeneous participation was intended to ensure consideration of a wide variety of view points from those intimately familiar with the networks, provide the necessary breadth and depth needed to accurately describe the processes and outcomes of the clinical research networks, and encourage greater buy-in of the results.The group of stakeholders to inform this initiative was expected to include individuals who:• Are familiar with and understand clinical trials networks from a practice perspective• Have familiarity with government research grant-making agencies and mechanisms• Have current knowledge of HIV AIDS related clinical research• Understand community perspectives related to HIV AIDS• Have operational and management responsibility for the Division of AIDS• Have operational and management responsibility for network(s)An invitation approach was taken to encourage engagement at al relevant levels within the networks, DAIDS, NIAID and related offices. Within the networks and DAIDS, individuals representing a wide range of positions, job responsibilities and seniority were invited.The rationale for the involvement of network stakeholders in the conceptual framework is rooted in participatory approaches to evaluation where those with a stake in the program or initiative  assume an active and substantive role across all phases of the evaluation ,27. It iWithin this context, the key method was a structured group conceptualization process  for gathering and organizing input from a wide range of sources. Concept mapping is a well established mixed methods social research approach that integrates rigorous multivariate statistical analyses with familiar qualitative processes such as brainstorming, sorting and rating of ideas to create a shared conceptual model ,31. The The methodology involves several distinct steps. In the first part, the idea generation step, stakeholders were invited to contribute ideas that completed the "focus statement" sentence: "Coordinated clinical research networks will be successful if...". Participants represented DAIDS staff and leadership, representatives of other government agencies, networks, clinical trials units and clinical research sites, the community and other constituencies having an interest in HIV/AIDS clinical trials research. In addition, numerous individual interviews were conducted and analyzed, together with documents related to the networks. The statements submitted in the initial idea generation were then synthesized into a representative set of success factors  that participants could work with during the idea structuring phase.The ideas were then structured -35 by haUsing a series of statistical analyses , participants' views about how to categorize the success factors were aggregated -35. The Over 300 stakeholders, representing every sector of the HIV/AIDS clinical research stakeholder community, contributed ideas that completed the "focus statement" sentence, "Coordinated clinical research networks will be successful if...". More than 1500 ideas were generated in response to that focus statement, which were then synthesized into a representative set of 91 ideas that describe what stakeholders believe are the factors critical to the success of the coordinated clinical research networks. Ninety stakeholders sorted the ideas by similarity/relatedness, and 308 stakeholders rated the ideas with respect to their importance to the success of the research networks. Table The concept map representing the success factors is shown in Figure To facilitate communication about the map and its components, each cluster has been labeled to describe the thematic content of the ideas that comprise the cluster. Just as with the individual ideas (numbered points), clusters that are physically closer together were deemed more similar, according to participants, than those more distant from one another. It does not matter whether an idea appears at the top or bottom of the map; a map could be rotated in any direction, so long as the relationships between the points are preserved. Distance between points – conceptual similarity – is what matters on a concept map. For more information about concept mapping in the context of this project, please see Concept Systems, Inc., 2008 .The evaluation framework depicts the broad range of factors that, in the view of the stakeholders, affect the success of the coordinated clinical research networks. The results illustrate the breadth of the activities and outcomes associated with this type of large scale, collaborative scientific research initiative.Focusing on each of the clusters within the concept map, and the ideas which comprise them , this group of ideas focuses on the ultimate aim of the trials networks to identify prevention and treatment strategies for HIV/AIDS that can lead to fewer new infections, and reduced morbidity and mortality in people living with HIV. Of the eight clusters on the map, Biomedical Objectives emerged as the most important success factor. That cluster had the highest average importance score (4.11) . That these two clusters were both rated among the top 3 success factors (average importance of 4.06), and were seen as highly related (as indicated by proximity on the map) would appear to affirm a close alignment between DAIDS goals in restructuring the networks, and what the network stakeholders believe most important for success.Moving "clockwise" on the map, the adjacent cluster, Collaboration, Communication and Harmonization. The emphasis of the ideas in this cluster is, as its name implies, on collaboration and communication both within and between networks. Statements in this cluster  as more important than the activities that lead to these types of outcomes. Also, the activities of resource sharing and inter-network coordination are largely a new demand on the networks, mandated through the restructuring process. While stakeholders recognize this concept as a factor in the success of the networks, these results would suggest that it is not yet fully valued by all participants.Next (again moving clockwise) is a large cluster labeled Operations and Management is also rated relatively lower in importance (3.80) by participants. Again, this cluster pertains to administrative, rather than scientific aspects of the networks' activities. The statements in this cluster also indicate that operations and management depend upon both the networks and DAIDS and suggest that a comprehensive evaluation of the enterprise includes both the grantees and the funding agency, DAIDS.Similarly, DAIDS Policies and Procedures cluster. As stated by stakeholders, for the coordinated clinical research networks to reach their goals, DAIDS policies must "reflect what is required for good science, protection of human subjects, and safety", be "transparent", "streamlined" and "clear". This cluster is very much process oriented, and is rated relatively lower in importance compared to other clusters (3.96).Attention to funder issues is even more explicit in the Resource Utilization contains subtopics that, taken together, describe the concept of resources in several ways, including human, time, materials and locations. For example, human resources issues include that "principal investigators demonstrate scientific leadership and innovation" and that they are able to "commit adequate time to network activities." Specific attributes of staff are mentioned, including the need for diversity and expertise in infrastructure development. Other statements focus more on issues related to clinical research site capacity and presumably refer to the many HIV/AIDS trials sites located in developing countries, where access to resources may be limited. Thus, a common theme across both the people and the functions is related to making wise use of resources. This set of statements relates closely to the principle of capacity building that figured prominently in the network restructuring design. The principles of efficiency and coordination also permeate this cluster. Capacity at the site level, in particular, is a focus of existing network evaluation activities. Resource Utilization is the fifth most important cluster (out of 8), with an average rating of 4.00.The cluster entitled Community Involvement emerged as one of the four highest rated success elements in the framework at 4.05. Within this cluster, the idea with the highest importance rating is: "the dignity and human rights of participants are respected." (#42). In addition to the protection of human subjects, the statements in this cluster emphasize the importance of community involvement at all levels and in every stage of study development and implementation. Adequate training and support must also be provided to enable this community involvement. This cluster sheds light on a topic that may be of special significance to clinical trials (by comparison to other types of research). Community involvement plays an essential role in ensuring the ethical and scientific quality of HIV/AIDS clinical research, its relevance to affected communities, and its acceptance by such communities . Community involvement may also be more challenging with HIV/AIDS (vs. other diseases) because the communities of interest often reside in resource poor settings , the social stigmas attached to HIV/AIDS, and the "disparities in power, wealth, education and literacy which often exist between the individuals proposing to conduct research and those who are hardest hit by the HIV epidemic" [On the left side of the map, ected." #. In addiRelevance to Participants. The focus of this cluster is on ensuring that network research: a) addresses questions of relevance to the communities and trial participants, and; b) can produce results leading to preventions and treatments that can be expected to be made available to the study participants and their communities. Special populations affected by the HIV/AIDS epidemics raise significant ethical considerations, some of which are captured in this cluster. This cluster's location directly adjacent to Biomedical Objectives (signifying that stakeholders found these elements to be closely related), is also notable, as this cluster addresses issues regarding who is involved in the studies and who will be the beneficiaries of the results. Relevance to Participants emerged as a very important success factor (4.09), second only to the Biomedical Objectives of the networks.Closely related to the issue of community involvement is The contextual knowledge required to understand or derive value from the concept map can vary depending on the user's focus. For those whose interest is to gain a sophisticated understanding of what the stakeholders of the HIV/AIDS trials networks believe are the factors critical to the success of the venture, it would be important to have: 1) a good familiarity with the NIH's and the investigators' goals for the networks; 2) knowledge of the diversity and multidisciplinarity within the networks; 3) a background in how clinical trials are conducted; 4) a grasp on the global pandemic from many aspects including the epidemiology, demographics, scientific and ethical challenges; 5) an understanding of the special operational and logistical challenges of HIV/AIDS clinical research; and 6) knowledge of the environment/milieu of related/surrounding efforts in which the networks function. With this kind of contextual knowledge, the relationships between individual statements (points) and groups of statements (clusters) on the map would have find their greatest meaning and could potentially provide the most insight as to how the data could be utilized.The concept map of success factors provides a framework upon which subsequent evaluation planning is continuously built. The concept map was used as the basis for a logic model of the coordinated clinical research networks that captures stakeholders' assumptions about how program activities lead to desired outcomes ,43. TogeDAIDS Policies and Procedures cluster in relation to the Biomedical Objectives cluster suggests they assume opposite ends of the logic model.Typically, logic models are constructed from lists of inputs, activities, outputs, and outcomes, often developed and considered categorically and independent form one another. The spatial features found in the concept map are important because it suggests that those clusters of ideas that are closer are more likely to be connected in the logic model. The understanding of how these concepts are related facilitates a more informed and efficient transition from the map to the logic model. For example, the location of the Each box in the logic model corresponds to a component or cluster obtained from the concept mapping analysis. The logic model describes a presumed program theory for the complex research initiative and conveys the sequence of expected processes and outcomes. In the end, the logic model developed as a part of this approach was based on a set of concepts that came directly from the stakeholders; with the components of the final logic model directly linked to the original concept mapping ideas submitted by the stakeholders. Thus, the logic model is more representative of the reality of the research networks, than had only one component of the system developed the model. This collaboratively developed model serves as a guide for identifying critical outcome pathways of greatest relevance and for identifying where measurement should be focused as the plan is implemented.what should be evaluated) and measures , as well as how these efforts should be operationalized in the networks and DAIDS. The EMTF's operationalizing efforts focused on compiling evaluation tools, processes, and methods from networks, developing potential indicators for concepts found in the framework, and identify potential data sources. Thus, the involvement of the EMTF in further interpretation and planning ensured a direct correspondence between the map, content, questions, and measures. This linkage is important as data is collected and analyzed in the future.An Evaluation Measurement Task Force (EMTF), consisting of evaluation coordinators from each of the clinical trials networks, along with selected DAIDS staff with evaluation expertise and knowledge of the networks, assisted in interpreting the framework and logic model. The EMTF used the concept map of success factors and the logic model as the foundation upon which to develop proposals for evaluation questions  evaluation metrics that pertain to well-established functions and processes, will likely include measures previously developed, utilized and refined within individual trials networks, and DAIDS. Reuse of existing measures offers the potential to build on past experience, gain efficiency, establish baselines and, possibly, performance benchmarks. In other areas (e.g. cross-network coordination and collaboration) there may be little experience to draw upon, in which case new measures may need to be explored and tested for utility and feasibility.The outcome of this participatory process will be a draft evaluation plan that describes the framework and logic model and associated potential measures, tools and resources and recommendations for piloting an initial cross-network evaluation system. With this type of design in place, evolving iterations of the system can be tested for feasibility and utility, and modified as needed.Often, evaluations of research programs are done as one time, ad hoc events, with little precedent for systems approaches.  invests in work that impacts significant social and scientific challenges and responds to new discoveries; 2) fosters a wide network of relationships that generates relevant questions, recognizes emerging issues, and sustains significant, cutting-edge programs of work; 3) develops and nurtures the human and organizational capacity to conduct research; and 4) recognizes and communicates its impact on the world . To dateAt the highest level, the findings from this process provide a 'global' view and insight into the network stakeholders' thoughts, views, and perceptions of the factors critical to the networks' success. The HIV/AIDS clinical research networks comprise thousands of individuals with a variety of skills and training, working in hundreds of different organizations, in almost 50 different countries. The diversity of expertise, interests, priorities and cultures represented in the networks, while vital to their strength, pose challenges to maintaining a sense of unity of purpose and teamwork. The findings reveal areas of the network that stakeholders see as mission critical, and the relative importance of these different areas. For example, we have learned, for the first time, that across the board, stakeholders believe that the biomedical objectives selected by the networks, are the most important factor for network success. This finding alone indicates that despite the diversity inherent in the networks, science is the primary driver. Given our interest in developing a comprehensive approach to the evaluation of the networks, this finding provides a data-driven basis for taking next steps, such as efforts to understand how the networks determine their biomedical objectives, how those objectives are vetted, how they align (or not) with those of other complementary efforts, how well they match (or not) the strengths and resources of the networks, and how successful have the networks been in reaching these objectives. A similar examination can occur across all clusters of success factors yielding a great deal of detailed information about what should be measured and how. Additionally, the findings allow us to see what other 'clusters' of success factors are seen by the stakeholders as being related, both conceptually and in their importance. For example, the findings reveal that scientific agenda setting (including prioritization) and relevance to study participants are both seen as being closely related to the biomedical objectives and nearly as important. This provides additional layers of understanding and again, suggests potential directions in which the evaluation system development can proceed, in direct alignment with what the networks themselves see as the most important activities for achieving success.The findings from this process allow us to map, in even greater detail, the success factors at multiple levels (i.e. statement or cluster) to the demographics of the stakeholder participants. For instance, we can start to determine if within one area of science (e.g. HIV vaccines) certain success factors are seen as more important than they are viewed by stakeholders working in a different area, such as HIV therapy. Similarly, we can learn how stakeholders' time in the networks or their roles relates to their views of what is important for network success. This kind of information can help to reveal the basis of conflict or competition which could be creating obstacles  and point to activities which could be undertaken to mitigate such.Taken together, these findings and the processes described here are the first of their kind relative to this large research initiative and provide valuable insights into the nature and functioning of the HIV/AIDS clinical research networks. The concept map and the logic model reflect evaluation criteria that account for the goals of multiple stakeholder groups and inform the first efforts to develop a systematic approach to evaluating this complex enterprise.In this paper, we described a stakeholder-driven conceptual framework development process as an initial step in the creation of an evaluation system. This participatory activity engaged scientists, staff, and community advocates with first-hand experience of the initiative, in co-constructing the framework for an evaluation system. This stakeholder-driven process served two purposes. It was designed primarily as a prospective planning tool to identify the success factors of the coordinated clinical research networks and, therefore, elements of the evaluation system. It also enabled a "pulse check" on the extent to which stakeholders have embraced the goals and guiding principles embedded in the guiding principles behind the recent restructuring of the clinical trials networks.Moreover, we detail how the results of the concept map relate to the goals of the networks, and point to how the map can potentially be used to guide the development of evaluation plans for this complex initiative. That said, the map can inform other 'views' or interests, for which an extensive background in HIV/AIDS clinical research would not be required. For example, for someone interested in researching the dynamics and complexities of team science, a contextual knowledge of that field could inform the interpretation of the HIV/AIDS network concept map (presented herein) in a very different way, and for a different purpose. In a sense, it depends on the 'lens' through which the user wishes to view the map, as this conceptualization activity could support multiple inquiries.In the context of evaluation of large scale scientific research initiatives we found support for the idea that "big science" is accountable for a wider variety of processes, activities and outcomes than traditionally organized science research. This finding is consistent with other writing on this subject ,19,20,45We also found that the sheer size and complexity of the initiative requires attention to a host of management challenges that would not be applicable to traditional individual investigator awards. The recent restructuring of the coordinated clinical research networks was undertaken to address many of these management issues, focusing on efficiency, coordination, responsiveness, capacity building and evaluation. This assessment indicated an awareness of these management issues among stakeholders, but revealed that overall, these stakeholders place more value on outcomes than the administrative and management processes required to achieve those outcomes.Finally, we found a number of ideas and concepts that emerged from the concept map that were consistent with other evaluation planning efforts carried out in large scientific research initiatives. Concepts related to scientific outputs and goals, communication and collaboration, and management policies and procedures have appeared in other framework development efforts ,21,32. SSeveral limitations and caveats of this work are worth noting. First, the results of the development of a conceptual framework are context specific. Although several clusters that emerged from the concept mapping process were similar to the content found in other large scale research evaluation planning processes where concept mapping has been used, the ideas generated, organized and prioritized by the stakeholders were specific to the DAIDS clinical networks. Thus, while limiting the generalizability of the results, the use of concept mapping had the advantage of focusing the scope of the evaluation, increasing the potential for an efficient and sustained evaluation effort. Second, the results of the development of the conceptual framework for the evaluation are highly dependent upon informed and meaningful participation. While we sought to engage broad-based participation from those that have a stake in the processes and outcomes of the network activities, it is clear that some groups had greater numbers of participants than others. This is fairly typical in participatory evaluation planning. Concept mapping has several advantages for the management of participation, including multiple opportunities for engagement, multiple forms of input, and multiple products for interpretation.Given the complexity, size, and scope of the activities of the clinical research networks, the time spent considering and engaging stakeholders in the conceptualization process is likely to yield benefits in later stages of the evaluation. Additionally, we used mean cluster ratings to represent the perspectives of the participants. This approach means that inferences about ratings must be made with caution. The primary intent of this project was to sample for heterogeneity to assure that a varied range of people had an opportunity to volunteer to participate and that no one who might want to take part would be excluded. While average ratings may represent well the views of the participants themselves and of the best represented subgroups of participants, it is not possible to say how well such averages represent groups that did not volunteer at comparable rates. In general, sampling issues in this context are a challenge and the opportunistic volunteer sampling used here was intended as a compromise between inclusion and representativeness. If subgroup comparisons are desired, we will incorporate a representative sampling approach.Through this example, we've described an approach to a participatory conceptual framework development process as a part of evaluating a large scale clinical research endeavor. These approaches to planning and identifying key elements of an evaluation system may serve as useful guidance to others who are also pioneering in this emerging field.The authors declare they have no competing interests.All of the authors helped to conceptualize ideas, interpret findings, and review drafts of the manuscript. JK conceived of the study and drafted significant portions of the manuscript. MK contributed to the project design and interpretation of the results and provided project support and management at each step. KQ conducted the concept mapping analysis, the background literature review and contributed to the overall manuscript writing. SR assisted in revisions of the manuscript. WT provided guidance to the background research and project implementation. All authors approved the final manuscript.Statements organized by cluster with average importance ratings by statement and cluster. Individual statements within concept map clusters, with mean importance ratings, by statement and cluster.Click here for file


Community structure is one of the key properties of complex networks and plays a crucial role in their topology and function. While an impressive amount of work has been done on the issue of community detection, very little attention has been so far devoted to the investigation of communities in real networks.We present a systematic empirical analysis of the statistical properties of communities in large information, communication, technological, biological, and social networks. We find that the mesoscopic organization of networks of the same category is remarkably similar. This is reflected in several characteristics of community structure, which can be used as “fingerprints” of specific network categories. While community size distributions are always broad, certain categories of networks consist mainly of tree-like communities, while others have denser modules. Average path lengths within communities initially grow logarithmically with community size, but the growth saturates or slows down for communities larger than a characteristic size. This behaviour is related to the presence of hubs within communities, whose roles differ across categories. Also the community embeddedness of nodes, measured in terms of the fraction of links within their communities, has a characteristic distribution for each category.Our findings, verified by the use of two fundamentally different community detection methods, allow for a classification of real networks and pave the way to a realistic modelling of networks' evolution. This is responsible of peculiar properties such as high robustness against random failures The modern science of complex systems has experienced a significant advance after the discovery that the graph representation of such systems, despite its simplicity, reveals a set of crucial features that suffice to disclose their general structural properties, function and evolution mechanisms Another important feature of complex networks is represented by their mesoscopic structure, characterized by the presence of groups of nodes, called communities or modules, with a high density of links between nodes of the same group and a comparatively low density of links between nodes of different groups Exploring network communities is important for three main reasons: 1) to reveal network organization at a coarse level, which may help to formulate realistic mechanisms for its genesis and evolution; 2) to better understand dynamic processes taking place on the network , which may be considerably affected by the modular structure of the graph; 3) to uncover relationships between the nodes which are not apparent by inspecting the graph as a whole and which can typically be attributed to the function of the system.what do communities in real networks look like? This is what we will try to assess in this paper.Therefore it is not surprising that the last years have witnessed an explosion of research on community structure in graphs. The main problem, of course, is how to detect communities in the first place, and this is the essential issue tackled by most papers on the topic which have appeared in the literature. A huge number of methods and techniques have been designed, but the scientific community has not yet agreed on which methods are most reliable and when a method should or should not be adopted. This is due to the fact that the concept of community is ill-defined. Since the focus has been on method development, very little has been done so far to address a fundamental question of this endeavor: Previous investigations have shown that across a wide range of networks, the distribution of community sizes is broad, with many small communities coexisting with some much larger ones However, the fundamental properties of communities in real networks are still mostly unknown. Uncovering such properties is the main goal of this paper. For this purpose, we have performed an extensive statistical analysis of the community structure of many real networks from nature, society and technology. The main conclusion is that communities are characterized by distinctive features, which are common for networks of the same class but differ from one class to another. Remarkably, such characterization is independent of the specific method adopted to find the communities.As our target is to study the statistical features of communities, we need to employ data sets on large networks containing high numbers of communities of varying size. Our data sets contain http://snap.stanford.edu/data/). Some networks are originally directed , but we have treated them as undirected. Further details on all networks can be found in the Overall, we have considered five categories of networks:Communication networks. This class comprises the email network of a large European research institution, and a set of relationships between Wikipedia users communicating via their discussion pages. Note that in both cases, communication is not necessarily personal but involves, e.g., mass emails, and thus these networks cannot be considered as social networks.Internet. Here we have two maps of the Internet at the Autonomous Systems (AS) level (i.e. nodes are groups of routers administered by a single entity), produced by the two main projects exploring the topology of the Internet: CAIDA (http://www.caida.org/) and DIMES (http://www.netdimes.org/).Information networks. This class includes a citation network of online preprints in www.arxiv.org, a co-purchasing network of items sold by www.amazon.com and two samples of the Web graph, one representing the domains berkeley.edu and stanford.edu (Web-BS), the other was released by Google (Web-G).Biological networks. This class contains the sets of interactions between proteins of three organisms: fruit fly (Drosophila melanogaster), yeast (Saccharomyces cerevisiae) and man (Homo sapiens).Social networks. Here we considered four datasets: a network of friendship relationships between users of the on-line community LiveJournal ; the set of trust relationships between users of the consumer review site epinions.com; the friendship network of users of slashdot.org; the friedship network of users of www.last.fm.The problem of choosing a method for detecting communities is a very delicate one. First, very efficient algorithms are needed, because the networks we study are large. This requirement rules out the majority of existing methods. Second, as discussed above, there is no common agreement on an all-purpose community detection method. This is because of the absence of a shared definition of community, which is justified by the nature of the problem itself. Consequently, there is also arbitrariness in defining reliable testing procedures for the algorithms. Nevertheless, there is a wide consensus on the definition of community originally introduced in a paper by Condon and Karp We begin the analysis by briefly discussing the distribution of community sizes . We see Next, we turn to the topology of the communities, and study the link density of communities and its dependence on community size. The link density of a subgraph is defined as the fraction of existing links to possible links, rees see . It shoumicrocommunities. For sizes macrocommunities. The stabilization of the average shortest path length in macrocommunities can be attributed to the presence of nodes with high degree, i.e. hubs, which make geodesic paths on average short. We remark that, since most of our systems have broad degree distributions, shortest path lengths are very short The compactness of communities can be measured using the average shortest path length For communication networks, there is a plateau with rved see . This stThe above picture is further corroborated by embeddedness of a node in its community with the ratio i.e. have no links to outside their community and thus Let us next take a closer look at the relationship between individual nodes and community structure. Here, the most natural property to investigate is the internal degree In i.e. densely connected subgraphs. Communities are ubiquitous in networks and typically play an important role in the function of a complex system – modules in protein-interaction networks relate to specific biological functions, and communities in social networks represent the fundamental level of organization in a society. The dual problem of formally defining and accurately detecting communities has so far attracted the most of attention, at the cost of a lack of understanding of the fundamental structural properties of communities. Our aim in this paper has been to uncover some of these properties.Since the advent of the science of complex networks, its focus has shifted from understanding the emergence and importance of system-level characteristics to mesoscopic properties of networks. These are manifested in communities, Our results indicate that communities detected in networks of the same class display surprisingly similar structural characteristics. This is remarkable, as some classes are really broad and comprise systems of different origin . The result is verified by two different community detection methods which are both partition-based but rely on entirely different principles. In accordance with earlier results, community size distributions are broad for all systems we have studied. Link densities within communities depend strongly on the network class. The average shortest path length displays similar behavior across all classes, initially increasing logarithmically as a function of community size (microcommunities) and then slowing down or saturating for communities of size The signatures we have found are a sort of network ID, and could be used both to classify other systems and to identify new network classes. Moreover, they could become essential elements of network models, with the advantage of more accurate descriptions of real networks and predictions of their evolution.i.e. its building blocks. Thus their statistical properties reflect the mesoscopic organization of networks, and our results indicate that this organization is similar within classes of networks.Although our results have been obtained using two different methods, their general validity merits some discussion. As the concept of “community” is ill-defined, every method for detecting communities is based on a specific interpretation of the concept. Furthermore, the underlying philosophies of methods can largely differ. Methods requiring that communities are “locally” very dense, such as clique percolation A very recent paper Appendix S1Appendix to the manuscript.(0.40 MB PDF)Click here for additional data file.


Globalization has brought India into the forefront of progress. This development has provided a substantial economic stimulus to enhance progress across India which includes enabling people to afford cars and increase their movement on the roads. Various multinational companies including motor vehicle manufacturers have created establishments in India. The increased usage of the cars has enhanced the need for developing the infrastructure where these motor vehicles can move safely. Developing safe roads which connect destinations and cities is a key foundation to infrastructural development in a country where the population is more than 1 billion. This commentary reviews various aspects of road safety in heavily populated and developing India where motor vehicle trauma is a modern epidemic.Road deaths and injuries are a global problem of massive proportions. Of all the systems that people have to deal with on a daily basis, road transport is the most complex and the most dangerous. In recent years, some important and major studies on the subject of road accidents and fatalities carried out by World Bank, World Health Organization (WHO), Transport Research Laboratory (TRL), and others have highlighted the growing significance of road crashes as a cause of death particularly in developing and transitional countries.In the year 1999, between 750,000 and 880,000 people died due to road traffic crashes, estimateAccording to WHO, every daWHO and World Bank in its report releasedThe study by WHO in 1996, ‘Global Burden of Disease’ showed that in 1990, out of 10 causes of deaths and injuries, road crashes were ninth on the list. However, forecast for 2020 shows thIt is estimated that without additional efforts and new initiatives, the total number of road traffic deaths worldwide and injuries is forecast to rise by some 65% between 2000 and 2020 and in low-income and middle-income countries the deaths are expected to increase by as much as 80%.The majority of road crash deaths, about 70%, occur in developing countries. Sixty-five percent of deaths involve pedestrians and 35% of pedestrian deaths are children. Over 10 million are crippled or injured each year. It has been estimated that at least 6 million more will die and 60 million will be injured during the next 10 years in developing countries unless urgent action is taken.The majority of road crash victims  in developing countries are not the motorized vehicle occupants, but pedestrians, motorcyclists, bicyclists, and nonmotorized vehicles (NMV) occupants. In high-income countries, deaths among car occupants continue to be predominant, but the risks per capita that vulnerable road users (VRUs) face are high.The study sponsored by Global road safety partnership (GSRP) provides a detailed summary of the road safety situation in the individual regions of the world. The diffFrom The basic reason for comparatively much better situation of HMC can be attributed to policies and programs adopted and carried out there to improve road safety. One of the most important differences between developed and developing regions is tht over the last 10 years or so the number of deaths taking place actually fell by about 10% in Western Europe and North America, while in the Asia/Pacific and Latin America regions road deaths continued to rise. Results also show that the highest fatality rates  worldwide occur in African countries, particularly Ethiopia, Uganda, and Malawi while fatality risk  is highest in a disparate group of countries including Thailand, Malaysia, South Africa, and Saudi Arabia.It should be emphasized that pedestrians are a particularly high-risk group throughout Africa and Asia as well as the Middle East. Car occupant casualties dominate in developed countries and are much more common in the Latin America/Caribbean region. Road traffic injuries involve issues of social equity, having a disproportionate impact on the poor in developing countries where most victims are VRUs such as pedestrians, children, cyclists, and passengers. As poorer members of society have less access to medical services, their chances of recovery after crashes are relatively lower.There are many reasons for the differences between countries and certainly between developed and developing countries. These might include differences in culture, education, socioeconomic characteristics, education, road user behavior, driver training, vehicle mode, and use , vehicle and road condition, vehicle mix and composition, and a higher use of rural and inter-city roads by pedestrians and slow-moving vehicles.Road traffic injuries also have disproportionate effect on young people. These accidental deaths come at any age without warning. Over 50% of deaths worldwide occur among young adults aged between 15 and 44. Males are almost three times more vulnerable than females: in 2002, the rates were 27.6 per 100,000 males and 10.4 per 100,000 females. As people in the age groups that are most economically active are most affected by road crashes, there is an increased burden on poorer countries attempting to tackle poverty and raise levels of economic growth. As per the Working Group on Road Accident and Injury Prevention and Control of Planning Commission, India[Risk on the roads is at least five times the average risk elsewhere in everyday life. The impact in terms of emotional and financial stress is enormous. Poverty, depression, physical illness, and suicide are common consequences. The happening of road crashes also leaves substantial impact on families and friends, and community in general. Reduced social interaction and cohesion is the result forcing people to remain indoors. In many countries, it has resulted in forcing people to remain indoors. It has also resulted in more sedentary life styles, with consequent health effects such as obesity and cardiovascular diseases.When accidents became increasingly common throughout the physical space of road networks, industrialized countries began to realize they were facing a new phenomenon. The first major change was seeing the accident as a man-made problem. Road traffic crashes were no longer viewed with a “fatalistic” attitude, as a question of fate, but as a consequence of human actions. Therefore, they could be prevented. The second major change that followed was seeing the accident as a public health problem, therefore deserving special attention from the state. This status was reinforced by two combined features: traffic fatalities increased to high levels and became as damaging as contemporary illnesses such as cardiovascular disease or cancer, causing large social and economic losses to society. The mobilization of society and the state around this issue led to new combined efforts in dealing with accidents. Major comprehensive, interdisciplinary programs were implemented in several developed countries from the 1950s to the 1970s, with a remarkable effect in reverting the upward tendency in the number and severity of traffic accidents.Unlike developed countries, the accident problem in developing countries has not yet assumed the status of a social issue. Public acknowledgement of the problem is still divided into conflicting views, ranging from the “fatalistic” to the “unavoidable-cost-of-development” approaches. Therefore, policy decisions have entailed different and sometimes conflicting actions, pursued independently by various public agencies, with poor outcomes.The year of 1970 was seen as one of the worst years for Japan in terms of road traffic fatalities, the fatalities recorded in India during the same year were almost the same as that of Japan. India recorded about 15,000 fatalities in the year 1971 while Japan had around 17,000 fatalities in 1970. Japan analyzed the severity of the problem and took up various road safety initiatives including its first road safety plan and hence was not only able to restrict the fatalities but also reduce them . On the In the year 1991, the total number of fatalities recorded in India was 56,400 while the European Commission (combined) recorded 56,027 fatalities during the same year . TherefoMoreover, the reduction in the number of fatalities was not only in decadal terms, but also consistently on yearly basis for each of the EC countries.Developed countries such as United Kingdom and United States have taken the issue of road traffic crashes very seriously, initiating certain policies and actions for its improvement. These programs and policies have now stabilized or in fact reduced fatalities in these countries . Other cAs countries develop death rates usually fall especially for diseases that affect the young and result in substantial life-years lost. Deaths due to traffic accidents are a notable exception: the growth in motor vehicles that accompanies economic growth usually brings an increase in road traffic accidents. The situation in high-income countries is quite different. Over the same period, traffic fatalities per person decreased by 60% in Canada and Hong Kong, and by amounts ranging from 25% to 50% in most European countries. This reflects a downward trend in both the fatality rate (deaths/population) and in fatalities per kilometer traveled that began in most organization for economic co-operation and development countries in the early 1970s and has continued to the present.These patterns are not surprising. The traffic fatality rate  is the product of vehicles per person (V/P) and fatalities per vehicle (F/V). How rapidly fatality risk grows depends, by definition, on the rate of growth in motorization (V/P) and the rate of change in fatalities per vehicle (F/V). In most developing countries, over the past 25 years, vehicle ownership grew more rapidly than fatalities per vehicle fell. The experience in industrialized countries, however, was the opposite; vehicles per person grew more slowly than fatalities per vehicle fell.A political commitment, across all ministries concerned, to deal with road accidentsA broad strategy, involving education, engineering and enforcement to deal with accidentsA clear vision and numerical targets for reductions in the different categories of accidentsA concrete plan with specific measures for implementation and enforcementInstitutional co-ordination within and between different levels of government and with private actorsCareful and critical evaluation of measures and their effectivenessAmong the countries that have been most successful in reducing the number of crashes, the main factors seem to include:It is obvious that above-mentioned initiatives have not been taken in India. The culture of road safety develops gradually and there are three distinct stages of such a development as outlined in From the study of the table, it can be seen that although India has crossed Stage-II it is only just at the entry point of Stage-III phase. It has yet a long way to go to fulfill the salient characteristics of Stage-III to hope for significant breakthrough in the area of road traffic safety. Many countries have been able to achieve a better safety record in last 30 years or so. The conscious approach adopted by these countries to address the road safety aspects for planning, engineering, etc. has been the main reason for their success. Initially the developed countries tried hard to reduce the number of accidents through the policies and plans, but after summing the situation they realized it was more fruitful to reduce the severity of accidents than decreasing the actual number of accidents. The methods undertaken by these countries include road safety audits, accident black spot reduction, speed regulation, etc. It was also felt that taking account of road safety problems during the planning stage itself reduces the burden of expensive solution later on.Road crashes are preventable. Significant number of road deaths and injuries are not a fundamental law of nature or an inevitable result of motorization. Countries that have been successful in improving their road safety like Sweden, New Zealand, Netherlands, Japan, and others have achieved success due to adoption of road safety action plans. Adoption of an appropriate road safety policy was the main driving force for such a major reduction in road fatalities in these countries. It was recognized that an appropriate road safety policy was one of the essential elements of a well-balanced overall transport policy and a public health policy. Some developing countries are also now demonstrating that significant reductions can be achieved via implementation of appropriate policies. For example, in Hungary, a 39% decrease in the number of accidents on roads happened between 1990 in comparison to 1994, largely due to the adoption of road safety policies and programs.Governments and road safety organizations act at many levels to diminish the risk of road crashes. This complexity demands the adoption of some method of planning. The advantages of planning such a complex process are quite evident: the goals become apparent to all parties involved; it simulates effective and efficient countermeasures to identified problem areas; it enables all relevant parties to deliver their contributions in a timely and co-operative manner and feedback to the plan allows easy modifications. Such road safety plans necessarily contain a vision statement, policy guidelines, strategies, and specific actions to be undertaken. A schemata for developing road safety policies and programs is shown in Road safety policy is nothing but a statement of various steps to be undertaken to achieve the visualized targets, set in this field to tackle identified safety issues. Every country wishes to make its roads as safe as possible, i.e. it visualizes that in future road accidents will be either zero or the minimum possible. However, state vision cannot be accomplished unless followed by suitable timeframe and fund allocation. Further, these stated targets cannot be accomplished unless and until accompanied by action plans suited to the requirements of the country within its political, economic, and social setup. All this requires identification of the problems, determination of appropriate measures and preparation of a well-justified, prioritized, time, and coordinated program of selected activities.In recent years, visions have been developed in a number of countries for improving road safety . The purVision Zero’ in 1997 to imply a widespread commitment from the society to give priority to prevent the worst consequences of road accidents. Similarly, Netherlands adopted vision ‘Sustainable Road Safety’ in 1991 and it has lead to the creation of new design principles. Regional pilot projects have been launched to implement the new strategies. The projects are supported at the national level.Though in Sweden, in 1996-1997 around 540 people were killed, it adopted ‘Road safety target can be defined as quantified road safety goal with an explicit quantitative limit and time frame. Road safety targets first appeared in the early 1970s in countries like Japan, Finland, and France.There are two different approaches to setting targets. The top-down or idealistic approach is based on aspirational standards as Canada's vision of having the safest roads in the world or Sweden's ‘Vision Zero,” which is about placing priority on preventing death and serious injury, with little prior consideration being given to how it could be achieved. Conversely, the target can be based on a more realistic objective, through a bottom-up process, where the basis for the target is the estimated effect of the available road safety measures. The latter approach, based on research and analysis, has been adopted by countries like Australia, New Zealand, the United Kingdom, and a few other countries. In fact, many countries use a combination of the two approaches, combining idealism and realism. On the one hand, the targets must have a certain degree of public support while, on the other hand, they must have a certain degree of ambition to initiate efficient actions.Road safety targets should be realistic and achievable, understandable, owned, based on facts, cost-effective and monitored. The existence of targets and targeted road safety programs increases the likelihood that safety policies will be implemented. Institutions in those countries with targeted road safety programs change their behavior once such a program is introduced. Targeted road safety programs can result in better integration of existing institutional efforts, generally require greater co-ordination and often produce a more focused allocation of resources.It is important to note that developing countries should not blindly set casualty reduction targets of the type typically being set in industrialized countries. These tend to be statements such as, “Reduction in 1993 number of deaths by 30% by the year 2000.” Most indMany developing countries are still approaching or just entering the explosive growth phase of motorization. Thus, private vehicle fleets will increase substantially in future years. During early stages of motorization, rapid increases in vehicle fleets inevitably result in accompanying increases in number of road accident deaths or injuries due to the populations' greater exposure to risk. Adopting a target such as ‘30% reduction on 1995 level deaths by 2000’ may in reality require reduction of 80% or more in the likely numbers of deaths that will occur by the year 2000, since actual deaths may rise by an additional 50% between 1995 and 2000 as a result of the previously mentioned increasing risk exposure.It is also important to establish behavior-related and other targets such as “percentage of drivers wearing seat belts to increase by xx percent,” “kilometers of pedestrian footpaths increase by yy percent,” or “number of pedestrian crossing facilities increase by zz percent,” all by a set date.Road traffic accident data analysis is an important tool for determining the main safety problems toward which measures should be directed. It is important to analyze trends in fatality crashes over a longer-time span, as well as trends for less serious crashes. Also a separate review of urban and rural areas and of problem areas in the road network is useful. It is also important to analyze exposure data and risk data. Several countries gather information on traffic behavior, road user knowledge, skills, and opinions. However, data on these variables are lacking in India.When planning traffic safety measures, an analysis of the present situation is not always sufficient; safety experts should attempt to prepare for the future. For example, in several countries the aging of the population, the growing economy, and the rising volume of traffic pose new challenges for traffic safety analysis. On the other hand, new technology offers opportunities for speed restriction, traffic management, and mitigation of collision consequences.Traffic safety measures are aimed at people, vehicles, the road, and its environment. In the planning process, all three elements should be considered. The areas where measures are planned and implemented are: land-use planning, transport systems and environment, traffic education, information, traffic control, telematics, and vehicle technology. Problem-solving calls for co-operation among different sectors.The planning of safety measures is based on decreasing exposure and risks. This requires information on the influence of the measures. At the international level, a great deal of research exists on the efficiency of traffic safety measures.The proposals for measures may involve research data collection, information on collisions, and organizing traffic safety work. These are so-called indirect measures that can be categorized separately in the program. The plan can be based on knowledge of organizational effectiveness . During the planning process, the options to implement, organize and finance the program at the regional and local levels must be considered. To commit various organizations to the work, officials from different sectors should be involved in the work from the outset.India, up to date, does not have any proper and formal national road safety policy despite the fact that it almost tops the world as far as the total number of road fatalities is concerned. The National Road Safety Council (NRSC) ever since its inception as a consequence of MVA 1988, has tried to formulate and finalize a road safety policy for India, but without much fruitful results.A fresh attempt to develop road safety policy was initiated by Ministry of Highways and Transport, G.O.I. at the instance of World Bank in 2003. Consultants were appointed to assist the Ministry to finalize the road safety policies and strategies. In the workshops held in connection with the project and in the Presentation made at Annual Session of Indian Roads Congress in Ahmedabad in 2004, it was learnt that the Ministry was deliberating on 11-elements for road safety policies under the vision ‘Safer Roads For Everyone.’ The first three policies deal with overall framework for road safety at the National level and include ‘Raising awareness about road safety issues among decision makers, citizens, and road users,’ ‘Providing enabling legislature, institutional, and financial base for road safety,’ and ‘Development of comprehensive road safety information database.’ The second set of policies, dealing with components of the road traffic system, include four elements and relate to safety policies for ‘Road infrastructure,’ ‘Vehicles,’ ‘Drivers,’ and ‘VRUs.’ The final group of safety policies, connected with important support systems for road safety, include four elements. viz., ‘Road safety education and training for special groups such as school children and various road safety professional groups,' ‘Enforcement,’ ‘Emergency medical services,’ and ‘HRD and research.’ It is hoped these policy statements will be adopted as National Road Safety Policy so as to serve as guidelines for road safety planning and programming at National, state, and local levels.Planning and implementing road safety programs on scientific basis and monitoring and evaluating those requires proper institutional, legal, and funding mechanisms. India's case is more unique as the existing NRSC under the chairmanship of the Minister in-charge of Road Transport and Highways at the Center is an overall high-level advisory body. It is neither a professional nor executive body dealing with road safety issues on a regular and continuing basis. So is the case with Transport Development Council (TDC). Although TDC meets generally once in a year, the NRSC has met only seven times during last 15 years. This is the reason, perhaps, the Working Group on Road Accident, Injury Prevention, and Control (RAIPC) appointed by the Planning Commission, Government of India, 2001, in its rThe existing NRSC suffers from certain pitfalls and is not in a position to attain the stated objectives in coordinating the road safety activities. The institution can be refashioned, responding to the needs and objectives, in desirable direction, but the human beings constituting NRSC cannot always be engineered. The focus must remain on keeping NRSC proactive for the cause of road safety development. Such a body has been responsible and effective for road safety activities elsewhere in France, Japan, Republic of Korea, and some other countries, where the Prime Minister chaired such high-level council meetings, and other empowered committees constituted at lower operational level to implement the decisions of high powered apex body like NRSC.Using roads is necessary for participation in the society. However, risk of death or injury while using the roads is disproportionate, as is evident from various analyses on the basis of global road accident data. Road accident statistics also reveal that poor and developing countries are bearing the brunt of the road safety problem, despite low levels of motorization. Still more unfortunate part is that India stands out well above other developing and developed nations with regard to road safety situation, rather in an uncomplimentary way. Things are getting bad to worse each year and yet nothing significant seems to be happening to improve road safety situation in the country. India seems to be almost stuck at the threshold of the third and the final phase of the road safety development process, which other countries have gone through and benefited. Road safety is being treated in a laissez faire way in India. Among the important reasons for such a situation are the lack of national commitment to the road safety, bureaucratic inertia, and public apathy to human suffering and economic losses due to road accidents.The industrialized countries in many parts of the world-treated accidents as a man-made and public health problem and implemented major comprehensive and interdisciplinary programs over the last quarter century. However, the accident problem in India have not yet been taken up in that perspective. The very limited actions to tackle the problem by various public agencies have been independent of any well-thought and well-researched road safety policy and associated action plans, and therefore had, as expected, poor outcomes.Fortunately, many of these deaths and injuries on roads are preventable and affordable as the experience of many countries show. The countries that have been most successful in reducing the number of crashes have many commonalities; the main factors include a political commitment, a broad strategy, a clear vision, a concrete plan, institutional development and co-ordination, and a careful and critical evaluation of measures and their effectiveness. Adoption of an appropriate Road Safety Policy and Road Safety Action Plans was the main driving force as it stimulated effective and efficient countermeasures to the identified problem areas and enabled all relevant parties to deliver their contributions in a timely and co-operative manner. Despite the fact that India tops the world as for as the total number of road fatalities is concerned, it does not have any proper and formal national road safety policy as yet.We know deaths due to road accidents can be drastically reduced, but we will have to convince decision-makers, stakeholders, and the public at large that the present framework of road safety in the country needs drastic improvement and up-gradation. It is only with suitable institutional, financial, and legal framework that we may be able to see proper road safety policies and action plans on the ground for increased road safety. Road deaths can be drastically reduced if enough people and interests are convinced that they want it to happen and are willing to work together to make it happen without any prejudices and vested interests.


Introduction. We investigated a cluster of pesticide poisoning in Orissa. Methods. We searched the village for cases of vomiting and sweating on 2 February 2008. We described the outbreak by time, place, and person. We compared cases with controls. Results. We identified 65 cases . The epidemic curve suggested a point source outbreak, and cases clustered close to a roadside eatery. Consumption of water from a specific source  and eating in the eatery  was associated with illness. On 31 January 2008, villagers had used pesticides to kill street dogs and had discarded leftovers in the drains. Damaged pipelines located beneath and supplying water may have aspirated the pesticide during the nocturnal negative pressure phase and rinsed it off the next morning in the water supply. Conclusions. Innapropriate use of pesticides contaminated the water supply and caused this outbreak. Education programs and regulations need to be combined to ensure a safer use of pesticides in India. Pesticides enhance economic potential through increased food and fiber production as well as through control of vector-borne diseases. However, they may also result in serious negative environmental and health implications . OrganopOn the morning of 2 February 2008, residents of Sindhikela village, Bolangir district, in the Indian state of Orissa were admitted to the hospital with complaints that included vomiting, profuse sweating and fits. Some were in serious condition. This created agitation and civil unrest in the population. Sindhikela is a small village with a poor rural population, where people sometimes do not have the resources to cook themselves breakfast: they eat a snack on the street instead. As a response to the alert, the Additional District Medical Officer  and a graduate from the Indian Field Epidemiology Training Programme (FETP) proceeded to the village immediately with the district task force to identify for the cause of the outbreak and ensure preventive and control measures. A physician examined all patients. We defined a case as occurrence of vomiting and profuse sweating between 6:00 AM and 8:00 AM on 2 February 2008 in a resident of Sindhikela. We searched for cases among patients attending the hospital and in the population. We prepared a list of all cases. We plotted an epidemic curve, drew a map of the residence of the case patients, and calculated age and sex specific attack rates to describe the outbreak by time, place, and person.To identify risk factors we conducted a case control study. We included all cases as defined above and recruited controls as the healthy neighbors of case patients. We collected information from the case patients and the control subjects on symptoms, date and time of onset, source of food taken in the last 24 hours and drinking water source. We analyzed the data with the help of Epi info 2005 (CDC). We compared the frequency of exposure variables between cases and controls through odds ratio with 95% confidence intervals.We collected residual specimens of food from a roadside eatery that we suspected as a possible source and sent them to a laboratory. We collected water specimens from different drinking water sources and sent them for chemical analysis to the public analyst, State Surveillance Cell, Bhubaneswar, the state capital. We collected vomitus from few case patients and sent those for examination.We interviewed the local population regarding the event. They reported that many affected had eaten in a particular roadside eatery. We visited the eatery and interviewed the owner. We traced back the drinking water source and examined the water supply system.P < .001, Chi square, 3 degrees of freedom).Sindhikela is located 100 km away from Bolangir . We confirmed the occurrence of an outbreak as 65 cases and two deaths were reported within an hour in the context of a background rate of less than one hospitalization per month . The distribution of cases over time  pointed The point source pattern of the outbreak and the clustering in a specific location close to a roadside eatery led us to suspect a mixed foodborne and waterborne origin. We included all 65 patients cases and 65 healthy neighbors as controls in our case control analysis. Cases and controls did not differ by sex. However, cases were more likely to be children 0–13 years  to kill street dogs. The pesticide was given in a container made of leaves. Three dogs died on the next day. The containers with the residual insecticide were thrown in the drains near Harijanpada. Pipelines supplying drinking water that were damaged at many places were located beneath the drain. These pipelines supplied drinking water twice a day, while during the rest of the time, they had a negative pressure. On 2 February 2008 early in the morning (6 AM), when the first phase of drinking water was supplied to Harijanpada, it may have rinsed off pesticide that had been aspirated in the pipelines during the nocturnal phase of negative pressure. The owner of the small roadside eatery near Harijanpada collected water from that particular point to prepared pakoda and the water-based chutney.The active ingredient of Folidol is Methyl Parathion, an organophosphorous compound. When ingested, it acts by inhibiting enzyme acetylcholinesterase in the body. This leads to accumulation of acetylcholine resulting in over stimulation of muscarinic and nicotinic receptors of skeletal muscles. This causes a syndrome including vomiting, sweating, and convulsion. The case patients during this outbreak had a typical syndrome of organophosphorous poisoning. However, we could not do any serological test to exclude another etiology nor estimate the serum cholinesterase and red blood cell cholinesterase levels. Further, autopsy could not be practiced on the two deceased case-patients because they died on their way to the hospital. We treated patients at the Sindhikela community health center, referred serious cases to subdivisional hospital, Titilagarh, and to a medical college hospital in Burla. We treated patients with intravenous Atropine, intravenous fluids, and other supportive measures .The population of the village frequently used Folidol to kill rats and street dogs, an inappropriate indication. After the dogs were killed, the containers with the residual insecticide could have contaminated the drinking water as the damaged pipe lines were going right beneath the drains and presented negative pressure. The actual product that was used, Folidol EC 50, is an emulsifiable concentrate, a WHO class I product. Those are actually banned for use in India (the villagers reported that they used an old stock procured before the ban). An accidental poisoning of a less potent organophosphorous (WHO class II or III) would have been unlikely to have lead to this many casualties.In addition to deliberate self-poisoning with pesticide, the burden of accidental poisoning with organophosphorous is unclear, because these episodes are not systematically reported. As an example, in 2006, in the same area of Bolangir, in the state of Orissa, we investigated a cluster of 33 cases of organophosphorous poisoning secondary to inhalation of Themit. The cluster occurred among agricultural workers who were planting in a paddy field that had been recently sprayed. Because of the nature of their activity, they were working with their face less than a meter away from the ground. If it were not for the presence of an epidemiologist from the Field Epidemiology Training Programme (FETP) of India posted in the district , this cluster would not have been reported. We communicated our findings to public health decision makers and local authorities. We stopped supplying the suspected contaminated drinking water and provided alternate drinking water through tankers. We discussed with villagers the issue of safe drinking water and proper handling of pesticides (including abstaining from inappropriate indication such as use to kill dogs). We recommended replacing and relining the pipeline. In the longer term, systematic epidemiological investigations such as the one we report must be conducted for clusters of toxicoses of unknown origin . Facilit