This study presents an assessment of the participation and training of nurses in public health areas in the Americas. Information was gathered through a literature review and interviews with key informants from Mexico, Colombia, and Paraguay. Results demonstrate that there is significant variation in definitions of public health nursing across the region and current systematized data about the workforce profile of public health nursing personnel is not available for many countries in the Americas. There are significant regional differences in the levels and types of training of nurses working in public health areas and an increasing number of nurses are pursuing training in public health at the master’s and doctoral levels. Many nurses carry out some or all of the essential functions of public health, but are not considered to be public health nurses. Generally, auxiliary and technical nurses have a broader presence in public health areas than professional nurses. In the future, regional health systems reforms should support increased recruitment and training of public health nurses, as well as stronger roles in public health research and health care at the individual, community, and population levels. Although nursing job responsibilities are often publicly perceived to be limited to direct patient care, public health nurses make substantial contributions to population health on a daily basis through their participation in patient education, disease surveillance, and public health campaigns. These contributions to public health are especially important in light of recent demographic and epidemiological shifts, health sector reforms, and health workforce changes across the Americas.Public health nursing is a specialized field within the nursing profession because it is population-focused, as practitioners often work with community members who are not in hospitals or other health care institutions, and community-focused, as practitioners focus on the relationship between population health and the environment—which includes physical, biological, and socio-cultural factors—in order to meet public health needs . Public Public health nurses play important roles in promoting public health across the Americas and currently comprise the largest group of professionals in the field of public health . There aAdditionally, the migration of health professionals in the Americas exacerbates existing health system inequities and workforce shortages across the Americas. The tendency of highly skilled workers to migrate increased in the 1990s due to comparative pay levels and working conditions. Currently, migration continues to strengthen health systems in developed countries, while weakening those in low- and middle-income countries. In order to meet the health systems goals of countries in the Americas, more research is needed to understand the migration of health workers, especially public health nurses .2.This study seeks to analyze public health nursing in the Americas in regard to workforce profile, specifically education level, job responsibilities, professional roles, and the number of personnel in each country. A literature review of articles published in the past 11 years was performed to assess recent trends in public health nursing in the region. To complement the information gathered through the literature review, interviews were performed with nurses who have undertaken leadership roles in public health activities in Mexico, Colombia, and Paraguay, in order to understand the situation of public health nursing in those countries. Information from the selected countries is important for this study because in each country the field of nursing is undergoing noteworthy changes, such as increased recognition of nurses as health professionals and renewed interest in community-based nursing practice. The literature review concentrated on information about the field of public health nursing and the interviews focused on the profile of the current workforce. The literature review and interviews were performed separately. The main question used for the literature review was: Is public health nursing a recognized and defined concept and/or field in the regional literature? This general question was focused through a series of steps in order to identify keywords that relate to education level, job responsibilities, and professional roles . These kenfermería, salud pública” and “Las Américas.” Next, searches were performed for “public health nursing” in combination with one geographic keyword  and one English keyword from steps 3−5 of the process to identify keywords. Searches were carried out in the same way for “enfermería, salud pública” in combination with the Spanish keywords. All searches were performed using the Boolean operations “and” and “or.” All searches were executed by selecting the field “all text,” in order to maximize the number of articles retrieved. Then, the search was refined by selecting the field “abstract”.The document search was carried out in multiple steps. First, searches were performed for the keywords “public health nursing” and “the Americas,” and “Inclusion criteriaprovided an interpretation and/or current definition of public health nursing in the region, or in specific countries in the region;described the relationship of public health nursing to the fields of public health and nursing;discussed the workforce profile and professional roles and/or performance of public health nurses or nurses who work in public health areas;covered the themes of education and/or competencies for public health nurses.The article:Exclusion criteriadiscussed specific functions of public health nurses without providing an interpretation or definition of the field;referenced specific time periods in the history of public health without substantial reference to the current state of public health nursing;focused on individual testimonies of public health nurses, without substantial reference to the current state of public health nursing;described the socioeconomic circumstances of current public health nurses;discussed ethics in nursing, as these arguments fall outside the scope of this research.The article:Databases were selected based on the criteria that they contain information in English and Spanish, have nursing and public health journals, and provide information about the fields of public health, nursing, and education. Databases that contain Spanish and English literature were consulted in order to minimize language bias and ensure a geographically broad search for studies about public health nursing. PUBMED, which is a free search engine maintained by the U.S. National Library of Medicine, was consulted because it contains 757 journals about nursing and 315 about public health. Another free search engine that was consulted was the Virtual Health Library, which is maintained by BIREME, a Specialized Center of the Pan American Health Organization. The Virtual Health Library was consulted because it incorporates a large number of materials in Spanish about public health and contains the health sciences databases LILACS and SciELO. Additionally, EBSCO was consulted because it has 1,059 journals about nursing, 542 about public health, and 1 about public health nursing; this database included Academic Search Premier, ERIC, MEDLINE and MedicLatina. The following inclusion and exclusion criteria were established to determine article relevance:Using the inclusion and exclusion criteria, articles relevant to the topic were selected based on the publication title and abstract content. This group of articles was reviewed for relevancy to the main question. Articles that were not relevant were eliminated. For each of the selected articles, information was extracted regarding the country or region of focus and the central themes. Then, that information was summarized in order to describe trends in public health nursing across the Americas.Because there is little information available regarding the number of public health nursing personnel in the Americas, information was gathered about the total number of public health and nursing personnel using materials published by the United Nations Population Fund and the World Health Organization.To complement the information gathered through the literature review, interviews were performed to determine the public health nursing workforce profile in the three chosen countries. A semi-structured interview was performed by telephone with one key informant from Colombia. Semi-structured interviews were held in person with key informants in Mexico and Paraguay. Key informants were nurses who were selected for the interviews based on their work experience, leadership in the field of nursing, expertise about recent developments in public health nursing, and participation in academia, the health sector, or both. For Colombia, an interview was conducted with a Colombian researcher at the University of Antioquia, Faculty of Public Health, who is an expert in the areas of nursing and public health. For Mexico, the Director of the Nursing Commission of the Secretary of Health was interviewed. For Paraguay, an interview was conducted with a group of seven senior-level administrators from the National University of Asuncion, the Ministry of Public Health and Social Welfare, the Paraguayan Nursing Association, and the National Institute of Continuing Education in Nursing and Obstetrics. During the interviews, the individuals interviewed provided official documents and grey literature from their respective countries.The interviews covered the following thematic areas: the number of available nursing personnel in the country; the various categories of nursing personnel; the educational requirements and job responsibilities of nurses who work in public health areas; and the roles nurses play in public health. A guide was used to conduct the interviews .The interviews were tape recorded with the consent of the informants. The material was transcribed and processed using ATLAS.ti, a computer software program designed for qualitative data analysis. Using this program, codes (or concepts) were defined and organized into families consisting of related codes, then compared with other families. The information was synthesized according to the central topics this research. After the interviews were processed, information was extracted based on the criteria that it provided an analysis of public health nursing and described the status of nursing personnel in relation to public health areas, specifically in terms of the number of available nurses and their training and job performance. This information was used to develop a case study for each country.3.3.1.Public health has been defined in several ways and over the course of its development has come to refer to a group of values and social activities focused on improving the health of the population. The concept of public health evolved from the area of hygiene, following the principle that specific actions can be taken to eliminate and/or establish barriers for infectious or pathogenic agents. The concept of public health has been modernized due to epidemiological changes in populations across the world and the emergence of a new disease profile that consists of chronic, non-infectious, and degenerative health problems.Currently, a key element of the concept of public health is its focus on the health needs of populations rather than individuals, in contrast to direct patient care which usually refers to a clinical focus. Public health experts focus on different specific aspects of the concept. In his definition of public health, Terris highlights community participation but does not explicitly include the participation of governmental institutions . In contA recent proposal supported by international health organizations states that public health can be structured in 11 essential functions, which should be carried out primarily by governmental institutions see  14]..14].It is important to note that the proper performance of the essential functions of public health requires the coordination of multiple social actors in the government, public, and private sectors. Also, the essential functions suggest that training in public health should include competencies that address a wide range of public health activities—from clinical procedures to administrative and planning tasks—which today require a stronger global perspective than initially thought when the original definitions were coined.3.2.Based on the essential functions of public health, it is possible to identify the roles that nurses should perform in health systems. It is widely recognized that nurses in Latin America have made great advances to improve their levels of training and labor conditions. However, in some countries there are major challenges for developments in the field of nursing. Analysts argue that the subordinate role of nurses in relation to doctors and other specialists within health sector managerial strategies and organizational structures restricts nurses’ ability to make clinical decisions. Consequently, this negatively impacts public perceptions about their contributions to public health and health care, including primary care and population health . In counNursing in Latin America is a women-dominated profession. Although men have recently shown interest in participating in nursing training, in general, women represent between 85–95% of all nurses . FurtherTraditionally, nursing does not possess the prestige of other professions in health systems across the Americas. Consequently, the demand for training in nursing is not as high as it is for other fields, such as medicine. This has generated a lack of properly trained nurses and a surplus of nurses who do not meet the requirements of public and private health institutions. In most countries, efforts have been made to increase enrollment in nursing schools with differing levels of success .In addition to problems with the level of nursing training, the migration of nurses, especially from Latin America countries, has impacted the profile of health human resources at the global level. Uruguay, Argentina, Peru, Colombia, and Chile are the main sending countries . The flo4.4.1.Nurses make up a significant proportion of the public health workforce in the Americas. While there are no data available about the number of public health nurses working in this region, there are separate data for the number of public health workers and the number of nurses.It was only possible to identify the number of public health workers for seven countries, but their level of professional training could not be determined. It is important to note that Brazil has a significantly high number of public health personnel for every 10,000 inhabitants, surpassing Canada, Honduras, and Paraguay see  20–22].–22.20–22The availability of nurses in the region is heterogeneous and it is not possible to establish a pattern of distribution according to economic indicators. In contrast to the availability of doctors, differences in the number of nursing personnel across the Americas do not correspond directly to level of economic development . Puerto 4.2.Only nine articles were identified that contained the search terms and met the inclusion criteria of the literature review. Results of the literature review suggest that although there is a range of articles about various topics pertaining to public health nursing, systematized information about the current state of the field across the Americas is unavailable see . ReasonsPublic health nurses are referred to by a variety of titles in the Americas. Health professionals in the U.S. and Canada often use “public health nurse” or “community health practice.” Names used in Latin America and the Caribbean include the following: public health nurse  in Mexico, community health nurse  in Honduras; primary care health nurse  in Venezuela; visiting doctor (“visitador médico”) in Guyana; primary care psychiatric nurse (“enfermera de atención primaria psiquiátrica”) in Belize; rural nurse  in Chile, family nurse (“enfermera familiar”) in Cuba; public health nurse (“enfermera sanitaria”); community nurse (“enfermera comunitaria”) . RegardlA 2001 PAHO report defines a public health nurse as a nurse who has at least completed high school and works with a program or activity targeting population health, a public health organization, or an entity contracted with the government . DespiteIn her article about nursing in Colombia, Gaviria-Noreña argues nurses should participate in health promotion and disease prevention through community participation and communication with individuals and groups, gathering socio-demographic data to monitor population health, and making decisions to restructure health services according to context-specific social, cultural, political, and economic factors . While tIn addition, the PAHO report states that the classification of public health nursing as a separate field within the discipline of nursing is becoming less common, as health organizations tend to emphasize particular areas of health, such as vaccinations or maternal and child health, rather than public health more generally . DespiteThe Cuban nursing experience reported by Torres Esperón and Urbina Laza shows that changes in the National Health System in the 1980s resulted in the expansion of nursing job responsibilities to include community and population level actions . These rIn Canada, the field of public health nursing has experiences changes in recent decades. Public health nurses have historically provided postnatal care and services, child health assessments, health promotion education in schools, immunizations, and community development projects associated with health issues . BecauseThe field of public health nursing is particularly well defined in the U.S. due to the sustained collaboration of academics and practitioners. The American Public Health Association defines public health nursing as “the practice of promoting and protecting the health of populations using knowledge from nursing, social and public health sciences” . Due to The Association of State and Territorial Directors of Nursing (ASTDN), which comprises a group of public health nursing leaders from across the U.S. and its territories, developed a set of public health nursing competencies in April 2003 . The comet al. report that although many versions of public health competencies exist, including the aforementioned public health nursing competencies, is it difficult to measure changes in public health nursing competency levels . Mo. Mo35]. The Nursing Commission of the Ministry of Health performed a survey in 2008 of 192,563 nurses and found that only 4,438 (or 2.3%) had studied public health in some way see  34]..34].Practically all nurses at the primary care level, who are predominantly auxiliary nurses, perform health promotion and prevention activities. A significant amount of their time is dedicated to developing national health programs, such as reproductive health, infant malnutrition, tuberculosis, vaccinations, and cancer. In the future, the participation of these nurses in monitoring individuals with chronic degenerative diseases and pregnant women should be strengthened. The prevention program of the Mexican Institute of Social Security (IMSS) offers training for its nursing personnel, which allows these professionals to develop their skills. The strength of the IMSS is based on the contributions of nursing personnel, as they provide information about health prevention and promotion for people insured by the IMSS. For example, nursing personnel give presentations and play videos about health prevention and promotion in waiting rooms at health centers and hospitals. They also offer individual consultation about health promotion and prevention in primary care settings. Furthermore, they provide periodic checkups for individuals with risk factors.According to the professional job descriptions and work systems of the main employers in the public sector, specialist nurses who have completed graduate studies do not work in primary care. Nurses who have studied public health and have high school and bachelor’s degree level education are able to work in primary care.In nursing education at the high school level, there are few courses related to public health.Experience with primary care is very limited during training.The majority of nurses who perform public health tasks in Mexico are auxiliary and general nurses who work in primary care.Specialty nurses who have completed graduate education work exclusively in hospital units.The percentage of nurses who have explicitly studied public health is very low.Following this information about public health nursing in Mexico, it is possible to highlight the following:4.3.2.According to the estimations of the University of Antioquia, Faculty of Public Health, in Colombia in 2005 there were 27,034 licensed nurses and 86,000 auxiliary nurses. Of these nurses, 23% had university training and 77% were auxiliary nurses . Nurses With respect to nursing training, there is a tendency of students to enroll in programs for auxiliary nurses with relatively basic educational requirements. Universities have not been able to substantially improve the nursing programs they offer, or increase the completion rate of students. The University of Antioquia is the only institution which offers a bachelor’s degree in nursing.According to information provided by the Ministry of Social Protection, in the area of public health 12% of nursing professionals work at the community level. Interestingly, the main actors responsible for public health interventions are local mayors, as they manage the budgets to finance these activities. With the recent health system reform which began in 1993, there has been a significant decrease of nursing personnel who work at the community level with special programs related to prevention, promotion, and control of chronic and infectious health problems. This area of nursing has practically disappeared, but recently there has been interest in reinitiating community level strategies through a new vision of primary care. The nursing department at the University of Antioquia has become a leader in this area by evaluating the resurgence of indicators concerning tuberculosis, acute respiratory infections, and acute diarrheal illnesses of children.During the past five years, the Nursing Department of University of Antioquia revisited primary health care as a strategy to implement a departmental development plan. This was achieved by identifying primary health care as a priority for general policy. This pilot strategy is noteworthy because it situates nursing personnel—from hospital-based nurses to nursing professors—as leaders of projects focused on family care. The program has a methodology of epidemiological surveillance combined with a socially sensitive design that targets families and the community, so that the population can learn about health promotion and disease prevention. There is a wide range of actions that involve health personnel, including providing consultation, monitoring disease, and preventing chronic problems, such as hypertension and diabetes. Other nurses lead health promotion projects that target youth to prevent anorexia, bulimia, sexually transmitted diseases, and teen pregnancy, which is a significant problem at the national level. Nurses also participate in projects with an explicit gender focus, especially those concerning reproductive health and domestic violence prevention.4.3.3.Nursing education has a long history in Paraguay. In fact, the National University of Asunción began awarding bachelor’s degrees in nursing more than 45 years ago. Asunción, the capital of Paraguay, has the highest concentration of nurses with university training .In general, nursing students are required to take public health courses during the four years of the degree program, and the majority of schools strongly emphasize public health in nursing education. Some of the major problems related to nursing education include the lack of a unified curriculum across programs, the lack of an evaluation and monitoring system for schools, and the shortage of well-trained nursing educators, especially at the auxiliary and technical levels.In Paraguay, there are more than 20,000 nurses, of which 16.7% have earned a bachelor’s degree in nursing see . In compThe Ministry of Public Health and Social Welfare employs 9,106 nurses, which represents 44.5% of Paraguay’s total nursing personnel. Of the nurses employed by the Ministry, 65.3% are auxiliary nurses see .All the nurses employed by the Ministry of Health perform public health tasks—from bachelor’s degree nurses to auxiliary and technical nurses. These nursing professionals focus on monitoring public health and managing health programs for immunizations, sexual and reproductive health, family planning, tuberculosis, diabetes, and epidemiological surveillance. Nursing personnel in the auxiliary and technical categories are able to assume responsibility of program execution, perform home visits, and give educational talks.According to the Paraguayan Association of Nursing, recently nurses have received better working conditions and higher salaries. In fact, in some cases the salaries have doubled. Recently, the health sector renewed funding for 5,300 permanent positions, 2,900 of which are in the area of nursing. The creation of positions with fixed working schedules has increased the number of nurses. Also, the creation of a code of ethics and nursing law has strengthened the field of nursing.5.Across the Americas over the last 20 years, public health nurses have been growing in numbers and gaining recognition, despite the low position of public health as a priority area of health systems performance.The majority of nurses in Latin America have low-level qualifications in comparison with other groups of health professionals, such as doctors and dentists.According to the results presented in this study, in many countries in the Americas efforts to provide the appropriate personnel for public health activities have not been adequate.The definitions of public health nursing competencies and responsibilities are often aligned with national health systems reforms, which currently tend to focus on strengthening primary care and public health interventions.Generally, technical and auxiliary nurses perform public health tasks while nurses with specialist and university training work in clinical care in hospitals settings.The bibliographic search shows that journals that publish articles on public health nursing issues are scarce in the region. Only seven journals were identified in Canada, the U.S., Mexico, Colombia, Cuba, and Paraguay.More than 50% of the literature consulted was written by researchers from academic institutions and the rest by international consultants and governmental officials. This suggests that despite the scarcity of available information, a broad range of stakeholders have demonstrated interest in the field of public health nursing.The bibliographic search also suggests that there have been attempts to specify public health nursing competencies across the Americas, and the greatest advances have been made in Canada, the U.S., and Cuba.The definition of the 11 essential functions of public health has been useful for defining the limits of the field, but has not significantly changed the field of public health nursing in many countries in the Americas.It is important that countries in the region prioritize the development of the public health nursing workforce by focusing on training and defining the responsibilities of nurses in relation to public health services. These countries should also develop health system goals that include training human resources in primary care with a strong emphasis on collective interventions for population health.Due to the lack of information about nurses and their participation in the field of public health, it is only possible to outline some aspects of the field of public health and highlight areas that require future study.6.This study is limited by the scarcity of information available about public health nursing, as many sources provide only tangential or indirect references to the field. This study was also limited by the terms set for the wide-document search. Using broader search terms could have yielded more information about public health nursing. This study was also limited by the use of references in English and Spanish. Future research that uses French and Portuguese could provide more information about the region, such as the status of public health nursing in Quebec, Brazil, and Haiti.Public Health Nursing and the Journal of Community Health Nursing are dedicated to the field and thus offer multiple studies of the field in each issue.It is important to note that while the bibliographic search of this paper showed that journals that publish articles on public health nursing issues are scarce in the region, Public Health Nursing: Scope and Standards of Practice (2007)—an acclaimed publication in the field—clearly defines public health nursing and is not aligned with national health systems reforms. It is important to acknowledge the participation of the Association of Community Health Nurse Educators (ACHNE) in development of the publication.In many countries in the Americas, public health nursing competencies and responsibilities support national health systems reforms, which currently center on improving primary care and public health interventions. This is not true for all countries in the Americas. For example, in the U.S., the American Nursing Association’s It is also important to note that the Quad Council public health nursing competencies were developed as a joint effort by the four members of the organization: ACHNE, the American Nurses Association’s Congress on Nursing Practice and Economics (ANA), the American Public Health Association-Public Health Nursing Section (APHA), and the Association of State and Territorial Directors of Nursing (ASTDN).It is only possible to outline some aspects of public health nursing in the Americas due to the lack of information about nurses and their participation in the field of public health in many countries. Reports published by U.S. organizations that focus on public health nursing issues offer clear explanations of the field, and could potentially serve as guides for future developments in the field of public health nursing in other countries.Future research should focus on the impact of the field of public health nursing on population health.


Coronaviruses: Molecular and Cellular Biology Coronaviruses are a group of single-stranded RNA viruses that mainly cause enteric and respiratory diseases in infected hosts. Before 2002, coronaviruses were known as important veterinary pathogens, as well as a cause of the common cold in humans. In 2002–2003, with the advent of the outbreak of severe acute respiratory syndrome (SARS), this picture changed. SARS was quickly shown to be caused by a novel coronavirus, and the ensuing explosion of research on coronaviruses is reflected in this new book.This multi-authored book contains 16 chapters and is organized into 2 sections. The first section of 7 chapters covers most aspects of coronavirus replication, from virus binding and entry into the cell to genome packaging. When appropriate, these chapters also draw on recent work with the closely related arteriviruses. Each chapter generally offers excellent and balanced reviews of the coronavirus literature through 2006, with a few references from 2007. The second section of 9 chapters discusses various aspects of the host-pathogen interface of several coronaviruses; the major focus is the SARS coronavirus, although the human coronavirus NL63 and murine, feline, and avian coronaviruses are also covered.This book provides a one-stop entry into current thinking in the field. For those unfamiliar with coronaviruses, the first section offers a current view of how these viruses replicate. Two areas that are not as well represented in this section are effects of coronavirus infection on cellular processes, such as the cell cycle, apoptosis, and other signaling pathways, and protein trafficking, virus assembly, and release. Separate chapters on these areas would have strengthened the book. In some ways, the second section of the book is not as satisfying. The 3 chapters on SARS coronavirus and the chapter on human coronavirus vaccine development have introductory sections that are somewhat repetitive. Including chapters on transmissible gastroenteritis virus and porcine respiratory coronavirus would also have been beneficial. That said, the chapters on SARS and the avian, murine, and feline coronaviruses are excellent. I heartily recommend that this book be placed in the library of every laboratory that is working on this fascinating group of viruses. It will be particularly valuable to newcomers to the field by providing a single entry point to recent thinking about these agents.


Torture continues to be a global problem and there is a need for prevention and rehabilitation efforts. There is little available data on torture survivors from studies designed and conducted by health professionals in low income countries. This study is a collaboration between five centres from Gaza, Egypt, Mexico, Honduras and South Africa who provide health, social and legal services to torture survivors, advocate for the prevention of torture and are part of the network of the International Rehabilitation Council for Torture Victims (IRCT).Socio-demographic, clinical and torture exposure data was collected on the torture survivors attending the five centres at presentation and then at three and six month follow-up periods. This sample of torture survivors is presented using a range of descriptive statistics. Change over time is demonstrated with repeated measures analysis of variance.Of the 306 torture survivors, 23% were asylum seekers or refugees, 24% were socially isolated, 11% in prison. A high level of traumatic events was experienced. 64% had suffered head injury whilst tortured and 24% had ongoing torture injury problems. There was high prevalence of symptoms of anxiety, depression, post traumatic stress as well as medically unexplained somatic symptoms. The analysis demonstrates a modest drop in symptoms over the six months of the study.Data showed that the torture survivors seen in these five centres had high levels of exposure to torture events and high rates of clinical symptoms. In order to provide effective services to torture survivors, health professionals at torture rehabilitation centres in low income countries need to be supported to collect relevant data to document the needs of torture survivors and to evaluate the centres' interventions. Despite a range of international conventions and prevention instruments dating back to the end of the Second World War, torture is still practiced by at least 81 governments around the world [any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a confession, punishing him for an act which he or a third person has committed, or intimidating or coercing him or a third person, or for any reason based on discrimination of any kind, when such pain or suffering is inflicted by or at the instigation of a public official or other person acting in an official capacity. It does not include pain or suffering arising only from, inherent in or incidental to lawful sanctions .What is not in dispute is that torture includes both physical and psychological methods of causing pain, distress or harm. Common forms of physical torture include beatings, burning, suspensions and stress positions, suffocation and drowning and electrical shocks. Psychological torture is most commonly seen in the forms of threats of execution and torture, threats against family members, mock executions, extended solitary confinement, sensory deprivation or overload, sleep deprivation, humiliation, and the forced participation in torture of others. Of course, most forms of torture involve both physical and psychological components, of which rape and other forms of sexual violence are clear examples.Given the absence of comprehensive torture treatment in most developing countries, some torture survivors turn to one of the many non-governmental torture rehabilitation centres around the world for assistance. These centres are typically founded and run by small groups of health professionals and human rights activists, often at great personal cost and risk. This paper reports on a collaborative study of torture rehabilitation undertaken by five such centres, namely:El Nadim Centre for Psychological Management and Rehabilitation of Victims of Violence in Egypt;1. Gaza Community Mental Health Programme (GCMHP) in the Palestinian Occupied Territories;2. Centro de Prevención, Tratamiento y Rehabilitación de las Víctimas de la Tortura y sus Familiares (CPTRT) in Honduras;3. Colectivo Contra la Tortura y la Impunidad A.C. (CCTI) in Mexico;4. Trauma Centre for Survivors of Violence and Torture (TCSVT) in South Africa.5. International Rehabilitation Council for Torture Victims (IRCT), a global network of 144 torture rehabilitation centres. These centres represent a diversity of socio-political and cultural contexts and their varied resources mean that a standardized rehabilitation program is neither possible nor desirable. Services may include the following:These centres are all members of the • Medical • Physiotherapy• Counselling and psychotherapy: Individual, family and group work• Legal, including medical legal reports for those seeking restitution for torture and assistance with the asylum seeking process• Prison visits• Outreach work to rural areas• Practical help with basic needs • Further social care and integration, including living skills, education and employment trainingKnowledge of the social and political context in which torture and recovery occur is key to understanding the needs of torture survivors. For example, torture survivors construct and reconstruct the meaning of their experiences and this is an important component of their recovery. How this meaning is constructed depends in part on the socio-political context in which the torture and recovery occur.In Egypt, the UN Special Rapporteur on Torture has reported that "torture is systematically practiced by the security forces, in particular the state security intelligence. In spite of denials of the government, the allegations of torture submitted by reliable, non governmental organizations consistently indicate that reported cases of torture are seen to be habitual, widespread and deliberate in at least a considerable part of the country." Torture in Gaza is closely related to the political situation which includes Israeli occupation and siege as well as a violent power struggle between the political factions Fatah and Hamas. Torture of Palestinians thus happens both during arrest by Israeli police and military, in Israeli prisons, as well as at the hands of the Palestinian political factions, and in the Palestinian prisons.In Honduras, torture has been carried out as a mechanism of domination and social control since the time of colonialism. In the 1980s a US backed National Security Doctrine characterized by the use of death squads and military police to abduct, torture and murder political opponents as well as human rights and peace activists, was established. Violence was and continues to be legitimized from the highest levels of economic and political power.Torture in Mexico is part of the structure of social inequity and responds to a doctrine of National Security similar to the one in Honduras. It is used for purposes of investigation, punishment, social demobilization and repression of ethnic minorities under the pretext of serving the purpose of counter insurgency in the continuous war against drug trafficking and organized crime. Political opponents of the government, syndicate members and leaders as well as leaders of lands rights, indigenous rights and other social movements, who openly criticize government actions, are targeted and "evidence" of their participation in drugs or arms trade is often planted on them or in their homes.During apartheid in South Africa, torture and arbitrary deprivation of liberty were widespread and institutionalized. South Africans were tortured for their political beliefs and their efforts to bring about a democratic society. Unfortunately, many attitudes, practices and habits from the apartheid time have survived. The debate on torture in South Africa today therefore focuses especially on places where people are deprived of their liberty: prisoners, detainees in police custody, asylum seekers and refugees, children in secure care facilities, and patients in psychiatric hospitals. South Africa is also currently home to several hundred thousand refugees and asylum seekers, many of whom have been tortured in their countries of origin.While the political contexts in which torture takes place may be very different, there is some evidence to suggest that the consequences for individuals and families are consistent across different settings. A recent meta-analysis of surveys on conflict affected persons from 40 different countries found torture to be endemic in countries affected by pervasive conflict and that torture is associated with mental disorder across these settings ,6 and 77. PrevioA small number of studies of treatment outcome with certain groups of torture survivors in particular contexts have been published. These studies tend to focus on short term international led programmes, rather than on the contribution of the ongoing work of permanent local torture rehabilitation centres. Bolton et al  have demThere is a lack of mental health research and research infrastructure in low income countries. The Global Forum and WHO mapped mental health research in Low and Middle Income Countries (LMIC) . Their s1. Demographics, torture exposure and clinical needs from the population of torture survivors attending their centres2. The recovery trajectories of torture survivors receiving care in the centres, and any differences between these patients and those who drop out of treatmentClinical Staff at the centres received basic training on research methods, and participated in the design and data collection in the course of their therapeutic work. They developed a standardized intake questionnaire, and then follow up questionnaires after three and six months. Data was collected on socio-demographics, trauma exposure and clinical needs of the torture survivors. Staff used a questionnaire previously developed for use with asylum seekers in the UK as a starting point to develop their own questionnaire . Data coth Edition Revised (DSM-IVR). HTQ (1-30) is a total score which derives from the symptoms and further signs associated with the diagnosis of PTSD.The selection of instruments by the five centres in the study was based on their acceptability, feasibility and language. They had to be brief, as staff and patient time was limited. The instruments used were the Beck Depression Inventory (BDI), the Harvard Trauma Questionnaire (HTQ) and the Camberwell Assessment of Needs, shortened version (CANSAS). The HTQ produces two scores of PTSD. HTQ (1-16) is a score derived from the first 16 items of the test which relate directly to the symptoms of PTSD as listed in the Diagnostic and Statistical Manual of Mental Disorders, 4The demographic and assessment data was captured in the five centres using a standardized spreadsheet. Qualitative data from the Honduran and Mexican centres was translated from Spanish into English. The data from all five centres was then combined, cleaned and analyzed using the Statistical Package for the Social Sciences (SPSS - Version 10). Data queries and problems of consistency were referred back to the five centres for comment and correction. Frequency distributions and descriptive statistics were calculated for all variables and scales. Differences in exposure, functioning and symptomatology were calculated between key groups  using chi-square tests and one-way analysis of variance. Differences between participants who left treatment (and so the study) before six months were also calculated on all baseline variables using chi-square and Mann-Whitney tests. Finally, changes in the number of symptoms, depression and PTSD scores over time were examined for those subjects who remained in the study using repeated measures analysis of variance. .The sample comprised of 306 torture survivors presenting for individual treatment to the five rehabilitation centres during the period January to July 2008 Table . These pOf the 306 torture survivors for whom baseline data was recorded, 148 (48%) dropped out before the three month assessment. A further 61 (20%) dropped out before the six month assessment. As a result treatment outcome analysis is based on the scores of 97 torture survivors who provided data at all three assessments (32%).Of the total sample of 306 torture survivors 172 (56%) were male. The mean age was 37.7 years (SD 14.2). 70 (23%) were exiles . Virtually all exiles came from African countries and were included in the samples from Egypt and South Africa. The most prevalent religions in this sample were Christianity (55%), and Islam (38%).40% of these torture survivors described themselves as single, while 42% were married or in a permanent relationship. 10% described themselves as divorced or separated, and a further 8% were widowed. The mean number of children was 2.1, although 35% had no children, and a few individuals had up to nine children. 14% of the sample (predominantly exiles) reported that they did not know where members of their immediate family were.When asked to rate their level of social support the majority (52%) described themselves as having daily support from family or friends. However, 24% were isolated, not having a member of their social network who they saw at least weekly. While the majority of torture survivors in this sample were living at home (82%), 11% were in prison, 5% were living in camps or shelters for exiles, and the last 2% were homeless.The level of education of this sample of torture survivors is summarized in table Whereas 65% of the sample described themselves as being entitled to work, only 45% of the total was employed. The others described themselves as retired (5%), taking care of the home and family (11%), studying (7%) or unemployed and searching for work (32%).These torture survivors reported having experienced an average of 5.4 (SD 4.1) of the different traumatic events listed in table While the exiles from Africa are significantly more at risk for a broad range of traumatic events, citizens are more likely to have suffered imprisonment. Men are more likely to have experienced torture, being close to death, serious injury, imprisonment and combat. Women are more likely to have experienced forced separation from family, and rape or sexual abuse.Data relating to head injuries sustained during torture was collected for 171 patients. Of these, 109 (64%) had sustained some form of head injury. 105 (61%) reported beatings to the head, 40 (23%) reported suffocation, and 18 (11%) reported drowning. 20 people (12%) reported losing consciousness during their ordeal.The rehabilitation centres participating in this study offer a range of different services, either directly or through referral to partner service providers. Table Ongoing physical health concerns were noted in 61 cases (20%). These are broadly categorized in table 62 patients (20%) also presented with torture related injuries that continued to cause pain or distress. Table Not all centres have doctors working at them, so some centres prefer not to make medical or psychiatric diagnoses unless absolutely necessary , for example for a medical-legal report. This in part reflects the professional make up of the centres and beliefs about the usefulness of a diagnosis. 196 clients (64%) did receive a diagnosis and these are detailed below Table .A more detailed clinical picture is presented by the results of the clinical interview summarized in Table Not unexpectedly, the symptom categories associated with anxiety disorders, post-traumatic stress disorder and mood disorders are the most prevalent. On average participating torture survivors reported symptoms in 5.9 of symptom categories listed in table The HTQ and BDI provided similar results. PTSD scores from part 4 of the Harvard Trauma Questionnaire were collected from 71 torture survivors (from Mexico and Gaza) Table .Although these results suggest that more than a third of this sample is symptomatic for PTSD, they should be interpreted with caution. The cut off score is taken from international norms and a single test like the HTQ cannot be used in isolation to make diagnostic decisions. However, what these results do tell us is that a significant group of torture survivors in this sample report that they frequently experience many of the symptoms associated with PTSD.Similarly high levels of depressive symptoms were measured using the Beck Depression Inventory. In order to ensure the best fit with available normal data the BDI I was used in Honduras and Mexico, and the BDI II was used in Egypt, Palestine and South Africa. The results are summarized in table A particularly high prevalence of depressive symptoms was recorded in Palestine and Egypt. Again, these scores should not be taken as diagnoses of major depressive disorder but as an estimation of the high levels of depression related symptoms in this sample.The total number of symptoms reported in the clinical interviews is significantly correlated with the total number of events experienced . Similarly scores on the HTQ and BDI tests are highly correlated  to each other. However, the HTQ and BDI scores are not significantly correlated with the number of events experienced.The results are for the torture survivors seen at both three and six months after initial assessment.2 = 15.4, df = 1, p = 0.000) and/or being tortured . Refugees tended to stay in treatment longer  as did people who lived with fewer people , and who reported having less social support . Finally, people reporting more PTSD symptoms tended to leave treatment earlier .Torture survivors who left the study before the six month assessment were not different from those who completed all three measurements in terms of sex, marital status, number of dependents, level of education, employment status, baseline depression scores, number of unmet needs, or overall number of symptoms. However, those who stayed in treatment until the six month measurement tended to be younger  and to have fewer children . People who stayed in treatment long enough to complete all three measurements also reported a more traumatic experiences  and were more likely to report being raped  as illustrated in figure Measurements of depressive symptoms show similar significant drops for both the BDI-I  and the BDI-II . These changes are presented in figures Finally, although only the Mexican centre was able to collect HTQ data at all three measurement points, these results show significant improvement as illustrated in figure Medical and psychological care of torture survivors very often takes place in extremely difficult social, political, and economic contexts, which has effect on both staff and patients. Commonly clinicians working with torture survivors are managing large case loads with limited access to space, equipment, medicines, and technical and emotional support. This situation is often exacerbated by humanitarian crises such as war, when conducting research is understandably low on the priority list. For example, four of the five centres in this study suffered from attacks on their staff and/or premises during the research period; the centre in Gaza suffered from a war with Israel and the Honduran centre from a military coup. Nevertheless, it is important that centres providing care to torture survivors use research to identify needs and evaluate the effectiveness of their work. Data can also play a crucial role in the prevention of torture through documenting allegations and evidence of torture and advocacy work.The study was a complex undertaking and there are many limitations to the data which must be kept in mind when interpreting the findings. In relation to the sample it is important to remember that this is a clinical sample of torture survivors who have received individual assistance at one or other of the centres. The patients described in this study are in no way representative of torture survivors in general, the vast majority of whom do not access health services.The high dropout rate must also be considered when interpreting the results. Unfortunately it is not possible to determine the range of reasons that resulted in the majority of patients not completing six months of care. However, these reasons are likely to include a lack of resources such as transport to reach the centres, and changes in life circumstances . Of course it is also likely that some patients left treatment because they felt that they had made sufficient recovery, or because they felt that the treatment was not meeting their needs.Differences in language, culture, training and the professional backgrounds of staff presented many challenges to the study. Across the various centres service provision and data capture were conducted in Arabic, Spanish and English. Furthermore, service providers came from different disciplines including medicine, psychology, nursing and social work. These disciplines all have their own assumptions and technical language, and even within disciplines training differs enormously between different countries. As such this study provided important lessons in international and interdisciplinary work. Although the researchers went to great lengths to ascertain standard meanings and interpretations in the data, it is unavoidable that in some cases the quality of data was compromised.Furthermore, the cultural applicability and standardization of the various instruments used was questioned. For example questions about substance use and sexuality are potentially insulting in some cultural contexts and health professionals decided to exclude them in many patient interviews, thus leaving too little data to analyze. Where possible the most glaring of these differences was allowed for in the analysis but it must not be assumed that the results were not influenced by cultural differences. Similarly, normal data and cut off scores have not been adequately tested for the varied study populations.Finally, although the assessments conducted were extensive there are some areas of functioning which were not adequately documented. A larger battery of tests was not feasible given the contexts in which service providers are working and so some compromises were required.While the high levels of symptoms are not unusual in a clinical sample such as this one, they do underline the enormous and lasting distress experienced by many torture survivors. However, it is surprising to note that the HTQ and BDI scores are not significantly correlated with the number of events experienced, a reminder that trauma and depression related disorders are a result of each person's appraisal of life events, rather than of the events themselves.The high prevalence of head injury  seen here is a particular challenge in the rehabilitation of torture survivors. Further research could investigate if head injury is adequately assessed and managed in torture survivors.This study does provide an important picture of the demographic profile, living situations, experiences, and needs of torture survivors who seek assistance from treatment centres in these low income countries. This work also explores some of the difficulties of service provision (illustrated in part by the high dropout rate) and shows that where torture survivors are able to continue in care, modest but significant gains are likely, although whether due to treatment provided or external factors is not known. Finally, whilst carrying out this study we found enormous difficulties of collecting data on torture survivors where health professionals work in extremely taxing environments leading to recommendations of research networks to be formed.The data collected showed that the torture survivors in the five centres had high levels of exposure to torture events and high rates of clinical symptoms. Data can be collected by clinicians working in torture rehabilitation centres in low income countries, despite their very difficult working environments. However in order to provide effective care for torture survivors further research needs to evaluate fully the interventions used. To do this the clinicians need to overcome the methodological and logistical challenges described above and to be supported by research networks.The authors declare that they have no competing interests.MHO, BAR, MHA, AS, MF, NP, GS, CLS, FVP, LSC, ADH, EL, APAZ, LC, CLM, YAJ, ZA and HMC participated in the design of the study. MHO, BAR, MHA, AS, MF, NP, GS, CLS, FVP, LSC, ADH, EL, APAZ, LC, CLM, YAJ and ZA gathered the data for this study. CHS performed the statistical analysis of the data. HMC, CHS and SG participated in the coordination of the study and drafted the manuscript. All authors contributed to the outline of the manuscript. All authors read and approved the final manuscript.Authors of this paper are a mix of psychiatrists, psychologists, social workers and anthropologists. All except CHS, HMC and SG work directly with torture survivors on a day to day basis in one of the five torture rehabilitation centres that have participated in this study. CHS is a South Africa based research psychologist, with a special interest in the rehabilitation of torture survivors. HMC is a psychiatrist and SG is a social anthropologist both were working at the IRCT secretariat as a medic and the project manager respectively.


Children and adolescents are important target groups for prevention of overweight and obesity as overweight is often developed early in life and tracks into adulthood. Research into behaviors related to overweight  and the personal and environmental determinants of these behaviors is fundamental to inform prevention interventions. In the Netherlands and in other countries systematic research into environmental determinants of energy balance related behaviors in younger adolescents is largely lacking. This protocol paper describes the design, the components and the methods of the ENDORSE study , that aims to identify important individual and environmental determinants of behaviors related to overweight and obesity and the interactions between these determinants among adolescents.The ENDORSE study is a longitudinal study with a two-year follow-up of a cohort of adolescents aged 12–15 years. Data will be collected at baseline (2005/2006) and at two years follow-up (2007/2008). Outcome measures are body mass index (BMI), waist circumference, time spent in physical activity and sedentary behaviors, and soft drink, snack and breakfast consumption. The ENDORSE study consists of two phases, first employing qualitative research methods to inform the development of a theoretical framework to examine important energy balance related behaviors and their determinants, and to inform questionnaire development. Subsequently, the hypothetical relationships between behavioral determinants, energy balance related behaviors and BMI will be tested in a quantitative study combining school-based surveys and measurements of anthropometrical characteristics at baseline and two-year follow-up.The ENDORSE project is a comprehensive longitudinal study that enables investigation of specific environmental and individual determinants of overweight and obesity among younger adolescents. The project will result in specific recommendations for obesity prevention interventions among younger adolescents. Adolescent overweight and obesity are important public health concerns in the Netherlands as well as in other western countries, due to the increasing proportion of adolescents classified as overweight or obese . ChildreAn important development in overweight and obesity prevention research has been the recognition of the environment as a potentially important determining factor for energy balance related behaviors . CurrentThe ENDORSE study  is conducted within the Center for Effective Public Health In the larger Rotterdam area (CEPHIR), an established collaboration between a university research center (Erasmus MC) and the Municipal Health Service Organization in the Rotterdam region. The data collection process takes place in close cooperation with the Municipal Health Service Rotterdam area, using an existing research infrastructure. In this article we describe the design and protocol of the ENDORSE study.The study comprises of two parts. The first part focused on the identification of the key energy balance related behaviors and the important individual and environmental determinants to examine. Based on this identification, measurement instruments were developed. The second part consists of a combined cross-sectional and longitudinal study utilizing these instruments.This phase of the ENDORSE study involved the development of questionnaires for adolescents and parents, interview forms for school representatives and canteen managers, an audit instrument used to observe the school and the neighborhood around schools, and a list of important census data on neighborhood level. To develop these instruments systematically, important behaviors and determinants were identified in the following steps.The most important energy balance related behaviors were identified to gain insight in the contribution of these behaviors to overweight and obesity in adolescents. Based on a review of relevant reviews of the literature, a preliminary list of specific relevant energy balance related behaviors was compiled. This list contained: watching television, computer use, sports, physical education, transport to school, leisure time activities, soft drink consumption, skipping breakfast, consumption of foods high in fat, fruit and vegetable consumption, portion sizes and dining out. Subsequently national experts on energy balance related behaviors were asked to review this list and suggest additional important behaviors and score the behaviors on the importance and changeability of each behavior. This procedure resulted in the following identification of behaviors to be examined in the present study: active transport to school, leisure time activities, sports, watching television, computer use, soft drink consumption, sweets/cookies/cake/chocolate bar consumption, savory snack consumption and breakfast consumption.In the ENDORSE study the environment was defined as 'anything outside the individual'. The environment can be subdivided by means of distinguishing various environmental factors. A suitable framework for the classification of environmental determinants is the Analysis Grid for Environments Linked to Obesity (ANGELO) . This frEnvironmental determinants previously shown to be important were identified by conducting two systematic reviews, one with physical activity as the outcome behavior  and the The theory of planned behavior (TPB) was used for the selection of potential individual determinants to be included in the study . The TPBThe ENDORSE study has a cross-sectional and a prospective two year follow-up component. Data will be collected at baseline (2005/2006) when adolescents aged 12–15 years, and two years later (2007/2008). Outcome measures are body mass index (BMI), waist circumference, physical activity, sedentary behaviors, and soft drink, snack and breakfast consumption. The study is an integral part of the ongoing health surveillance system of the Municipal Health Service in the Rotterdam area (Youth Monitor Rotterdam), in which general health, well being and related factors of youth aged 0–19 years are monitored. The Medical Ethics Committee of Erasmus University Medical Center reviewed the proposal and issued a "declaration of no objection" for the ENDORSE project.Schools located in the Rotterdam area that participate in the Youth Monitor Rotterdam (YMR) (N = 56) were invited for participation in the ENDORSE study. A letter and an information sheet explaining the goals and the logistics of the study were sent to school principals. The schools Principals were contacted by a researcher, upon which they could express their interest in participating in the study. If necessary, additional information to make a more informed decision was provided. Subsequently, a random sample of 17 school locations was drawn from the pool of schools that were willing to participate, after stratification of the schools according to the area in the city in which they are located. Stratification was done, to ensure a range of physical and cultural environments. Rotterdam is the second largest city of the Netherlands. It has approximately 600,000 inhabitants of which 46% are of non-Dutch origin .Five classes in each participating school were randomly selected for participation in the cross-sectional study, which took place in 2005/2006. All adolescents in one class participated in the study, unless they or their parents indicated that they were not willing to participate. The adolescents in the first year classes were also asked to complete the questionnaires at two years follow up. To have sufficient power, we assumed (conservatively) that obesity inducing risk behaviors will be present among at least 40% of adolescents, and we assumed moderate effect sizes of determinants on behaviors. With a significance level of .05 and 80% power, a sample size of approximately 600 students would be sufficient. Since we plan to do separate analyses for girls and boys we aimed at including 1200 students. First year adolescents were over-sampled to 800 as these adolescents will be followed up two years later.The ENDORSE study follows the logistics of the YMR. The YMR routinely collects data among adolescents in the first and third year of secondary school. The school levels vary from lower vocational training to high school. According to the usual procedure of the YMR, the ENDORSE study was announced through a letter to the parents. This letter explained that the YMR was extended with an extra part, aimed to gain insight in the prevalence and causes of overweight. Parents could keep their child from participating in the study by sending the attached form to the adolescent's teacher (passive consent procedure). Approximately two weeks after the usual YMR questionnaire, the adolescents completed the ENDORSE questionnaire confidentially during a school hour with a teacher and a research assistant present. Within a month after completion of the ENDORSE questionnaire, two trained research assistants measured height, weight, waist circumference and pubertal development according to standardized procedures described in a measurement protocol. The adolescents were asked to come in succession to a private room where they were measured without shoes. After the anthropometrical measurements, the adolescents completed a Tanner scale to assess pubertal development . To guarTwo observers independently conducted audits of the schools, school canteens, schoolyards, and an area of 300 meter radius surrounding the schools. The observations were conducted within three months from the completion of the adolescent questionnaire. A brief interview with canteen managers and school representatives was part of the audit. One of the observers conducted the interviews with school representatives, and the other observer conducted the interviews with the school canteen managers.Census data (year 2005/2006) from the Center for Research and Statistics (COS), the research center of the municipality of Rotterdam was collected on all neighborhoods of Rotterdam.In the follow-up data collection the same procedures are used. All measurements  are conducted within one week per school. As an incentive for their participation, the adolescents received a key holder.The ENDORSE questionnaires were developed by using existing validated Dutch questionnaires where possible. If no validated questionnaires were available the ENDORSE questionnaires were informed by questionnaires on related topics that were used in ongoing projects in the Netherlands, and questionnaires used in other countries. Relevant parts of these questionnaires were adapted to tailor the specific behaviors identified. If no relevant and validated questionnaires were available, new questions were developed for the ENDORSE study. The ENDORSE study contained the following measurements: adolescent questionnaire, parent questionnaire, interviews with school representatives and canteen managers, observations of the school environment, census data collection and adolescent body measurements. These are described in detail in the following paragraphs. All determinants measured in the ENDORSE study are listed in Table Physical activity and sedentary behaviors were assessed with an adapted version of the Activity Questionnaire for Adolescents & Adults (AQuAA)  which is a short questionnaire to assess physical activity at school and during leisure time, active transportation to school and sedentary behaviors in leisure time. The structure of the AQuAA was obtained from the SQUASH-questionnaire . The AQuDietary intake was assessed with food frequency questions referring to a general week, and a 24-hour recall question. The questionnaire included TPB items for all behaviors. All the questions on TPB variables were measured on a five-point bipolar scale. Attitude was assessed with two items by asking if the adolescent considered the behavior as good or bad, and as pleasant or unpleasant  – very bad (-1)'). Subjective norm was assessed with one item, for example 'my parents consider eating breakfast as very good (+2) – very bad (-2)'. Modeling was assessed with two items by asking if the parents and friends perform the behavior (' My friends eat snacks...a lot (+2) – very little (-2)'). Perceived behavioral control was assessed with two items by asking how easy or difficult the behavior is to perform (How easy/difficult is it for you to eat breakfast? Very easy (+2) – very difficult (-2)), and by asking if the decision to perform a behavior is completely under the control of the adolescent  – no, that is not fully my own decision (-2)). Intention to perform the behavior was assessed with one item asking how certain the adolescent is to perform the behavior in the coming six months  – no certainly do not (-2)).Habit strength of dietary and physical activity behaviors was measured by means of the Self Report Habit Index . This quExternal cues that can influence eating and drinking patterns were questioned with nine items on a four point Likert scale  – never (-2)), for example 'I get hungry when I see snacks or candy' or 'When I walk past a fast-food restaurant, I feel like buying something. These questions were based on the external eating behavior questions from the Dutch Eating Behavior Questionnaire  and adapIn the adolescent questionnaire the following perceived environmental determinants were assessed: availability and accessibility of facilities for physical activity and food, school factors, neighborhood factors, parenting factors and economic factors. Demographic factors  were available for each adolescent through the YMR questionnaire.The adolescent questionnaire was pre-tested among ten adolescents by means of cognitive interviewing. Subsequently, the questionnaire was completed twice by 89 schoolchildren (aged 13–14) ten-days apart to assess the test-re-test reliability and other psychometrics of the questionnaire. Items with low reliability were adjusted or deleted from the questionnaire.Parental behavior, family and household environmental determinants were assessed in the parent questionnaire. Parental physical activity and sedentary behaviors were assessed with the adapted version of the AQuAA , referring to activities in the past week . Dietary behaviors were assessed with food frequency questions referring to a general week. Neighborhood factors as perceived by the parents, such as safety in neighborhood and attractiveness of neighborhood, parenting practices, parental allowance, availability and accessibility of soft drinks, breakfast products, snacks/sweets, television set and parental self-reported body weight and height, and demographics  were assessed. One parent completed this questionnaire.To assess school food and physical activity factors, pre-structured interview forms were developed for interviews with the school canteen managers and with a school representative. The interview form for canteen managers contained questions on the availability of food products, opening hours of the canteen, pricing policy, who will receive profits from the foods sold, and canteen policies, for example if there are agreements on the assortment with the catering organization. The form also included information about the soft drink and snack vending machines, e.g. how often the vending machines are filled. The interviews with a school representative were aimed at gaining insight in school policies regarding diet and physical activity. As a basis for the interview form, the 7-item school-wide food practices scale was used . This scAn audit instrument was developed to assess the availability and accessibility of foods and physical activity facilities in the schools, in the schoolyards and in the neighborhood around schools. The audit instrument consists of a pre-structured form with five parts: school information, school building, nutrition, physical activity and school environment. As much as possible, the instrument had a 'tick box' answering format and included observation of 'objective' characteristics. When more subjective characteristics such as 'state of maintenance of the school yard', or 'traffic situation around the school' were reported, photographs were taken from pre-defined angles. The audit instrument included also a description of the item to be observed. The neighborhoods around schools that were observed were defined as a radius of 300 meters from the school. This definition was based on the basic assumption that the facilities in the neighborhood around schools should be accessible in a general school lunch break of approximately 30 minutes, and that adolescents use facilities that are close by the school. The audit instrument included maps of the 300-meter radius around the schools, on which the route walked to observe the area could be drawn and the location of green spaces could be indicated. The first part (A) of the audit instrument involved some general school information e.g. the address and number of pupils. Part B involved items on the school building e.g. number of floors, entrance for schoolchildren, availability of an elevator and location and visibility of stairs. Part C involved observation of the school canteens e.g. counting the number of soft-drink and snack vending machines in the canteen, checking the items that are available in these machines, how well they were filled and advertising in the canteen. Part D involved observation of the school physical activity facilities e.g. the bicycle shed, facilities for activity and aesthetics of the schoolyards. Part E involved observation of the neighborhood around schools e.g. the facilities for physical activity  that were visible from the schoolyards and that were present in the neighborhood (300 meters). The component of the neighborhood observation related to dietary intake involved observation of the food retail outlets  that were visible from the schoolyards and that were present in the neighborhood around schools.The audit instrument first was reviewed by experts on accuracy and completeness of the instrument for its intended purpose. Secondly, the instrument was pilot tested by conducting the observations at two schools and in the corresponding neighborhoods with two observers. Important aspects of the pilot test were the completeness of the forms and feasibility and suitability of using the definition of 300-meter radius for school environment. After the pilot tests at the two schools, the audit forms were adapted if needed. The adapted forms were tested at a third school, by three observers.Census data was utilized to gather additional environmental data regarding the neighborhoods around schools and the neighborhoods in which the children live. The data included area-level household income, educational level, residential types, percentage of residents aged 10–19, percentage unemployment, percentage living on social security, percentage of rented houses and owner-occupied properties, mean value of houses, percentages of various ethnic groups, number of stores, fast food restaurants and the amount and type of green spaces, water, bicycle tracks and foot paths. The census data could be linked to the home environment of the adolescents with information on the ZIP code, which was asked in the adolescent and parent questionnaires. Neighborhoods were defined based on a formal classification from Statistics Netherlands.Body height was measured without shoes with a Seca 225 mobile height rod with an accuracy of 0.1 cm. A calibrated electronic digital floor scale (SECA 888 class III) was used to determine body weight of the participant in street clothes, without shoes, with an accuracy of 0.1 kg. Waist circumference was measured using a spring loaded measuring tape (SECA 200) to the nearest 0.1 cm. The waist circumference was measured twice. In case of a difference of more than 1.0 cm between these two measurements, the waist circumference was measured twice again. Adolescents self-reported on their stage of pubertal development using drawings of Tanner stages  in the bThe ENDORSE study is a comprehensive, longitudinal study in which both individual and environmental determinants of selected obesity related behaviors in adolescents are examined. The study has several strengths. It examines both sides of the energy balance equation. It was designed to examine the influence of environmental factors on obesity related behaviors and BMI and objective measures for mapping the environment were included. Moreover, the study includes environmental factors in various settings, including the home, school and neighborhood. The study involves assessments of both individual and environmental determinants, as opposed to many previous studies, that focused on one or the other. The study has a longitudinal design, allowing analyses of prediction rather than cross-sectional associations only. To date, there are very few studies that examine environmental factors of energy balance related behaviors longitudinally. There is an urgent need for such studies, in order to be able to draw stronger inferences for relationships between environmental factors and BMI. However, there were also some limitations in the study protocol. For instance previously validated instruments were not available for all necessary measures. Another limitation is that assessments of adolescents' and parental physical activity and dietary behaviors are self-reported. The definition of environment and neighborhood is also somewhat arbitrary. The scale of environment to be studied needs further conceptual development . A clearThe ENDORSE study contains rich data examining individual and environmental determinants of energy balance related behaviors among adolescents. With this information the influence of risk behaviors for overweight and relationships with socio-economic status and ethnicity can be investigated. Individual and environmental determinants of obesity-related behaviors among adolescents can be examined as well as the interactions between individual and environmental determinants of obesity inducing behaviors. Therefore, data will be analyzed by means of multi-level regression analyses and structural equation modeling. Eventually, the ENDORSE study will provide objectives and entry points for prevention of overweight interventions in younger adolescents. In 2008 the questionnaires for adolescents and parents, the school policy interview forms and the audit instrument will be made available on the Internet .The authors declare that they have no competing interests.KvdH drafted the study protocol with input from all authors. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:


The global health community is interested in the health impact of the billions of dollars invested to fight malaria in Africa. A recent publication used trends in malaria cases and deaths based on health facility records to evaluate the impact of malaria control efforts in Rwanda and Ethiopia. Although the authors demonstrate the use of facility-based data to estimate the impact of malaria control efforts, they also illustrate several pitfalls of such analyses that should be avoided, minimized, or actively acknowledged. A critique of this analysis is presented because many country programmes and donors are interested in evaluating programmatic impact with facility-based data. Key concerns related to: 1) clarifying the objective of the analysis; 2) data validity; 3) data representativeness; 4) the exploration of trends in factors that could influence malaria rates and thus confound the relationship between intervention scale-up and the observed changes in malaria outcomes; 5) the analytic approaches, including small numbers of patient outcomes, selective reporting of results, and choice of statistical and modeling methods; and 6) internal inconsistency on the strength and interpretation of the data. In conclusion, evaluations of malaria burden reduction using facility-based data could be very helpful, but those data should be collected, analysed, and interpreted with care, transparency, and a full recognition of their limitations. Otten and colleagues  recentlyThe ideal method for assessing impact requires that observed changes in malaria morbidity and mortality  are attributed to exposure to an intervention(s). An experimental study design is needed to assess what would have happened had that exposure never occurred. Although it is highly unlikely that evaluations of real-world programmes would involve such methods, an examination of how an evaluation deviates from the ideal can be used to judge the evaluation's validity. Note that it should be mentioned that programme evaluations can still be robust even if ideal experimental designs are not used.The first concern of the evaluation by Otten and colleagues is that it is unclear whether the objective was to assess the programmatic impact on the malaria burden at health facilities or in communities. The background states that the authors intended to assess the impact of malaria control on "health facility burdens"; however the article does not explain what this means, and the implication is that the facility-based results reflect malaria trends in the community. Although the terms "health facility burden" and "community burden" might not have formally recognized definitions, the former typically refers to caseloads , commodity use, and costs incurred in health facilities; and the latter means malaria cases and deaths in the general population. While both types of burden are important, a trend in one does not necessarily imply a corresponding trend in the other. For example, a community case-management programme that primarily shifts care-seeking from facilities to village-level providers could decrease the health facility burden with little effect on the community burden. More importantly, while accurate and complete health facility records are an excellent data source for evaluating changes in the health facility burden, these data might not produce valid trends for the community burden.The second concern is that a lack of detail in the article makes it difficult to judge the validity of the data. For example, in Rwanda, the statement that "all sampled facilities performed malaria smears on all suspected malaria cases" does not seem plausible. Not a single patient was missed--even during weekends and evenings? Nationally, according to Rwanda's Health Management Information System, in 2007, only 45% of facility-based malaria cases were laboratory-confirmed [Third, the sampling procedures make it difficult to assess the representativeness of the data. The authors stratified their convenience sample so that selected facilities would be spread out across malarious areas of both countries. However, the selection of "sites where intervention scale-up had been relatively rapid and successful and where health facility data were of relatively good quality" suggests that results were biased toward areas likely to have a relatively greater impact. Additionally, the number of health facilities was small: 19 in Rwanda and 13 in Ethiopia. With such small samples, even the use of probability sampling does not guard against skewed results.Fourth, the analysis did not include trends in factors that could influence malaria rates and thus confound the relationship between LLIN and ACT scale-up and the observed changes in malaria outcomes. Key examples of such factors are rainfall, implementation of a home-based fever treatment strategy, and indoor residual spraying--all of which could have changed the rate of malaria cases seen at health facilities, but not necessarily cases of other illnesses. Even a simple graph of such trends over time together with the malaria outcomes can be helpful in understanding the potential effect of these factors (see example in Bhattarai and colleagues ).Fifth, some of the analytic approaches raised concerns. For example, at least one conclusion was based on a very small number of patient outcomes. In Ethiopia, for children under five years of age, the reported impact on inpatient deaths was based on a decrease of 11 deaths per year during the reference period to four deaths in 2007. Another issue with the analytic approach was that there appeared to be some selective reporting of results, in which decreases in malaria  were attributed to the scale-up of LLINs and ACT, but similar decreases  were not discussed.Additionally, the statistical methods were not ideal and might have led to an underestimation of uncertainty. The methods did not account for the correlated nature of the data , and a failure to adjust for correlation  could make results appear more precise than they actually are. Another statistical issue was the use of linear regression to model counts when a non-linear model  would have been more appropriate. For example, if the trend for inpatient cases in Figure four continued for another year or two, a linear model probably would have predicted a negative case count (obviously impossible). Perhaps, if more suitable methods had been used, the decline of outpatient malaria cases in Ethiopia, adjusted for linear trend , would no longer be statistically significant. Indeed, to us, the 2007 data point of outpatient malaria cases in Figure four appeared to be simply a continuation of the sharp decline seen in the preceding years.Finally, there is internal inconsistency in the report on the strength and interpretation of the data. Specifically, although the discussion appropriately states that a variety of factors in Ethiopia "make it impossible to draw firm conclusions yet regarding the causal relationship between the observed malaria declines and LLIN and ACT scale-up," the abstract's conclusion was that: "Initial evidence indicated that the combination of mass distribution of LLIN to all children < 5 years or all households and nationwide distribution of ACT in the public sector was associated with substantial declines of in-patient malaria cases and deaths in Rwanda and Ethiopia." Readers who only saw the abstract could easily conclude incorrectly that the evidence showed that scale-up led to a reduction of the burden in Ethiopia.It is exciting that interventions to control malaria are being scaled-up across Africa and that the coming years will likely be rich with evaluations demonstrating reductions in malaria's terrible burden. Evaluations of malaria burden reduction using facility-based data could be very helpful--especially when used in conjunction with representative community-based surveys of intervention coverage, all-cause child mortality, and biomarkers, such as parasite prevalence and anaemia. However, facility-based data need to be collected, analysed, and interpreted with care, transparency, and a full recognition of their limitations. Many of these issues are described in greater detail in a guidance document from the Monitoring and Evaluation Reference Group of the Roll Back Malaria Partnership , and an LLIN: long-lasting insecticidal nets; ACT: artemisinin-based combination therapy;The authors declare that they have no competing interests.AKR wrote the initial draft of the manuscript, and all co-authors made substantial contributions to the content. All co-authors approved the final version.None.


The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury, by Haleema Shakur, Ian Roberts, et al.A response to and comment on  As stated in the BRAIN TRIAL manuscript , Xytis wtwo versions of SAEs. The first version was a completed CRF (absent an SAE form) in which the investigator ticked the box indicating that an adverse event was serious, but did not fill out the SAE form, which is a regulatory requirement for an SAE. A separate entity, HPM, had responsibility for reporting SAEs  to Xytis and to the appropriate regulatory authorities. Investigators ticked about twice as many Adverse Events, Serious boxes as they filled out SAE forms. While the BRAIN TRIAL manuscript treats SAEs as always being a unique population, in fact the reconciliation of Adverse Events, Serious with real SAEs reported to HPM was not accomplished until May of 2008, despite the fact that LSHTM received the SAE forms from the investigators and forwarded them to HPM. As of 1 November, fully 56.4% (54 out of 94) of the Adverse Events, Serious reported to the DSMB were actually adverse events that were not Serious Adverse Events according to the protocol (as subsequently reported by LSHTM). In fact, at the time the trial was stopped, HPM had received only 49 SAEs, and as required, had reported these to regulatory authorities. Thus the decision by the DSMB to interrupt the trial was based on mostly (56.4%) erroneous information. The failure of LSHTM to "clean" the database in a timely manner was a direct cause of the excessive accumulation of Adverse Events, Serious.The BRAIN TRIAL manuscript clearly states the definition of a Serious Adverse Event. What is not said is that in this clinical trial, LSHTM used The Manuscript inaccurately states the Study Objectives, which were defined by the protocol as a Primary Objective "to evaluate the safety of different doses of XY2405 when used as a treatment for acute TBI in order to inform dose selection for a phase III trial" and a Secondary Objective "to assess the effect of XY2405 on mortality, morbidity among patients with acute TBI".Xytis' concern is that the BRAIN TRIAL manuscript is biased. For example while the authors performed both Per Protocol and Intent to Treat analyses, the authors selectively chose data from one or the other for presentation.Another example of bias is when the authors state "It is unknown to the authors whether the decision to withdraw funding was influenced by the unscheduled un-blinded analyses", is patently false. It is well known by the LSHTM authors that Xytis formally requested termination of the trial in mid-November, long before Xytis had access to un-blinded data.In terms of un-blinding, it should be noted that I was the only Xytis employee who had access to un-blinded data, and I was not involved in the conduct of the trial or the analysis of the data, which was under the control of LSHTM. However, several LSHTM employees who had direct involvement in the trial  reviewed un-blinded data while queries were ongoing and prior to the final data analysis. The impact of these un-blindings on their analysis is not known.The HIREOS scale has not been published, and as such may be a source of bias.Table It is apparent that deaths are about even among the four treatment arms. What is striking however, is the death rate among the three GCS cohorts. One would have expected that patients with GCS scores of 3, 4 and 5 would have suffered the highest death rate. The average of this group was 16% mortality. The average of the next highest cohort of GCS entries (GCS 6 - 8) was 32%, twice that of the supposedly more severe traumatic brain injury cohort. This is a most unexpected result. A careful review of the protocol as well as the training instructions given to investigators indicates that no policy or procedures were established to assure that a consistent initial GCS was taken. The nature of TBI is that many patients, particularly those with polytrauma, are partially or completely sedated, on ventilators, etc., and assessment of their initial GCS score can vary considerably over a few hours. Strict criteria are needed to ensure that all clinical sites use the same criteria for the entry GCS score. The data from the BRAIN TRIAL clearly indicates that the initial GCS score is not reliable in this trial. Inasmuch as the authors "adjusted" the data, including the DRS and HIREOS, to take into account the entry GCS scores, their entire analysis is flawed.In my opinion, the BRAIN TRIAL manuscript is both biased and flawed, and cannot be relied upon as a reliable presentation of the data from this clinical trial.DRS: Disability Rating Scale; DSMB: Data Safety Monitoring Board; GCS: Glasgow Coma Scale; HIREOS: Head Injury Related Early Outcome Score; LSHTM: London School of Hygiene and Tropical Medicine; NIH: National Institutes of Health; HPM: Healthcare Project Management, Geneva; CRF: Case report form.Xytis and LSHTM had an adversarial relationship, resulting in legal proceedings in the High Court in London. The potential that bias may exist in this Letter, as well as in the BRAIN TRIAL manuscript should be considered.The factual contents of this paper and the details provided about the clinical trial reported therein have not been verified by BioMed Central Limited ('the publisher') its agents or employees. This article has been published in accordance with this journal's obligation to report all clinical trials, in the public interest. No liability is accepted by the publisher, its agents or employees in connection with the contents of this paper.Dr. Simmon has been the CEO and President, and COO of a number of public and private biotechnology companies, including Alpha 1 Biomedicals, Cortex Pharmaceuticals, Merrimack Pharmaceuticals, and Xytis, Inc. In those capacities, he has been responsible for the conduct of Phase II clinical trials evaluating new therapeutic agents for Hepatitis B, Hepatitis C, Schizophrenia, Alzheimer's disease, Mild Cognitive Impairment, Rheumatoid Arthritis, Psoriasis, AIDS and an AIDS vaccine. Among the academic and research institutions involved in these clinical studies were NIH, Harvard Medical School, Stanford University, University of California San Francisco, University of California Los Angeles, Wayne State University, and the University of Miami. He has authored or co-authored more than 30 peer reviewed scientific articles.