To assist small hospitals in providing advanced stroke treatment, the Norwegian Directorate of Health has recommended telemedicine services. Telestroke enables specialists to examine patients via videoconferencing supplemented by teleradiology and to provide decision support to local health care personnel. There is evidence that telestroke increases thrombolysis rates.In Norway, telemedicine has mainly been used in non-critical situations. The first telestroke trials took place in 2008. The aim of this paper is to present an overview of telestroke trials and today’s status with telestroke in Norway. Based on the divergent experience from two health regions in Norway, the paper discusses crucial factors for the integration of telestroke in clinical practice.This is a descriptive study based on multiple methods to obtain an overview of the practice and experience with telestroke in Norway. A Web and literature search for ‘telestroke in Norway’ was performed and compared with a survey of telemedicine services at the country's largest hospitals. These findings were supplemented by interviews with key personnel involved in telestroke in two of four health regions, as well as hospital field observations and log data of telestroke transmissions from five of the hospitals involved.In Norway, experience in telemedicine for acute stroke care is limited. At the beginning of 2014, three of four regional health authorities were working with telestroke projects and services. Integration of the service in practice is challenging, with varying experience.The problems are not attributed to the technology in itself, but to organization (availability of staff on duty 24/7 and surveillance of the systems), motivation of staff, logistics (patient delay), and characteristics of the buildings (lack of space).collaboration potential in the technology with consistent procedures for training and triage, availability of the equipment, and providing advice beyond questions concerning thrombolysis.Prerequisites for successful integration of telestroke in clinical practice include realization of the  Norway has been one of the pioneers in telemedicine and e-health  along with Northern America and Australia -3. In 19Stroke is the third most frequent cause of death in Norway, and the most common cause of severe disability. ‘Time is brain’ : In stroA stated objective in Norway is that all 5 million inhabitants should have equal access to health services regardless of where they live. Long distances with fjords, mountains, and a harsh climate make travel to a specialized hospital a challenge, even with a publicly funded, decentralized hospital structure. Norway should therefore be a highly suitable country for telemedicine in general and telestroke in particular. Telemedicine is recommended by the Norwegian Directorate of Health in the 2010 national guidelines for stroke treatment to enable smaller hospitals to provide advanced stroke treatment . An objeIn Norway, the first telestroke trials took place in 2008. As there is no systematic report on the experience in the field, the aim of this paper is to present an overview of telestroke trials and today’s status with telestroke in Norway. Based on the divergent experience from two health regions in Norway, one succeeding and one failing to integrate a telestroke service, we will discuss crucial factors for the integration of telestroke in clinical practice.This is a descriptive study of telestroke in Norway, presenting (i) an overview of the hospitals where telestroke has been (tried) implemented; and (ii) some hospitals’ specific experience with telestroke. For the overview and status (i), a Web and literature search for ‘telestroke in Norway’ was performed and compared with a survey of telemedicine services at the country's largest hospitals from 2012 . Based oTo obtain in-depth understanding of health personnel’s experience, including non-technological challenges with the use of telestroke in Norway, part (ii) includes log data of telestroke transmissions, hospital observations and interviews with key personnel from two of the four health regions. These regions were selected based on their experience with telestroke services, successes and failures respectively. The data comprise of one week of field observations from three hospitals, log data analysis, and interviews lasting 30–90 minutes with 23 hospital doctors and stroke nurses in the five hospitals involved. In addition, two of the authors have first-hand experience with telestroke in their regions. The study has been approved by the Regional Committee for Medical and Health Research Ethics .There is no national systematic recording of telestroke consultations in Norway. At the end of January 2013, three of four regional health authorities had, or had tried telestroke  established telestroke with the local hospital Voss as a pilot project in 2008. The service has been in routine operation since 2009. The teleconsultations were recorded consecutively. During the period 2008–2012, 53 telestroke consultations were performed, of which 33 resulted in thrombolysis. One teleconsultation was unsuccessful for technical reasons, and one concerned the acute patient pathway after the thrombolysis window. Voss hospital has about 70 stroke cases per year, and reported that the number of thrombolysis rose from zero to about eight cases per year after the hospital was connected with telestroke. In 2011–2012, the thrombolysis rate was 13% at Voss and 15% at HUS .When a patient arrived at the Voss local hospital with suspected stroke, the department of neurology at HUS was contacted while the patient was sent for a computed tomography (CT) scan. A radiologist assessed the images, and the neurologist went to a dedicated telestroke studio with VC equipment and online access to the CT images to assist in the assessment of the patient. Telestroke was used for all patients with symptoms of acute stroke, including those outside the thrombolysis window. It was estimated that telestroke took 3–4 minutes longer than a telephone consultation. If technical problems occurred, the equipment was restarted. Telephone was used if the restart did not work. The specific stroke treatment was sometimes changed during the telestroke conference. Although the doctors at the local hospital were mostly confident about the treatment, they reported that telestroke helped them to keep up to date with current stroke treatment. All new doctors received telestroke training. Senior doctors at both central and local site described the service as good, and emphasized the following success criteria for telestroke: Motivated staff, radiologists and neurologists on call 24/7, teleradiology by a common radiology network, and a low threshold for contacting the department of neurology at the central hospital. They reported that the challenge was unclear responsibilities for technical and financial maintenance of the communication lines.In the Western region, two other telestroke services were tried established: one  was recently established and therefore had limited experience with the service; the other  introduced telestroke between the central hospital and two local hospitals in 2009. The second service was never put into operation due to unresolved allocation of responsibility related to ICT operations and networks.In the Northern region, a telestroke project was launched after the volcanic eruption in Iceland in April 2010, which paralysed air ambulance services. Telestroke was established between the department of neurology at the central hospital in Bodø and two local hospitals on the archipelago, Lofoten and Vesterålen . When a patient with suspected stroke arrived at the local hospital, the local doctor decided whether to contact the neurology department, telephoned the neurologist on-call, and connected the VC equipment. Telestroke was the preferred choice at Lofoten hospital when thrombolysis was relevant. Health staff at the local hospital reported that they found telestroke a better service than telephone and requested the service extended to 24/7 availability. However, the central hospital found that the patient volume was too low for the service to be feasible when decisions needed to be made instantly.At Lofoten hospital, the telestroke equipment was initially placed in the emergency department, then moved because of lack of space, so that it had to be taken out from storage and connected when needed. This was described as a disadvantage in a situation under time pressure. At Vesterålen hospital, the telestroke unit was placed in the intensive care unit due to limited space, and not in the emergency department where the patient first arrived. Here too, the availability of the equipment was described as cumbersome and time-consuming. In Bodø, the neurologist had to move to another wing of the hospital for teleconsultations.In the Southern region, Kristiansand Central Hospital established telestroke with a local hospital (Flekkefjord) in the second half of 2012. Since 2007, this local hospital had carried out 40–50 thrombolysis treatments with telephone-based consultation and teleradiology. The central hospital chose a PC-based VC-system allowing the neurologist to examine the patient from any office, which saved time and streamlined the work procedures. The image quality was described as satisfactory. The disadvantage was that the local hospital could not see the stroke specialist. At the local hospital, the telestroke conference took place in the emergency department before the patient was sent for CT. The procedure was that all stroke patients should have telestroke, including those who were not candidates for thrombolysis. The same PC-based solution was introduced in another local hospital  in early 2013, when their after-hours neurologist service was discontinued. Here the telestroke equipment was installed in the radiology department, where the patient was examined on the CT table via a fixed wall-mounted camera. It is too early to comment on the experience from the Southern region.Although Norway has extensive experience with telemedicine in general, there is limited experience with telestroke and the volume is low compared to international experience. Few services have been operative over time and are integrated in clinical practice. Haukeland University Hospital is an exception, where telestroke was started in 2008 and has been in routine use since 2009.International telestroke networks have established requirements for participating centres to consult the stroke centre in connection with specific indications, including arrival at the hospital within the thrombolysis window, reduced level of consciousness, progressive strokes, brainstem symptoms, or cerebral haemorrhage ,21. The International literature reports that telestroke results in an increased thrombolysis rate . In FinlA major challenge is that the patients arrive too late at the hospital, or the time of symptom onset is unknown. In Bodø Hospital this applied to more than 80% of the patients with cerebral infarction . It is nIn this study few technical problems were reported related to the equipment or transmissions, but there were unresolved allocation of responsibility related to ICT operations and networks. Other logistics were more challenging, especially the location of the VC-equipment in the hospital. If telestroke involved an extra ‘stop’ for the patient, the service was perceived as impractical. At the hospitals in the Northern region, the lack of space in the emergency department reduced the availability and accessibility of the VC-equipment. Haukeland hospital had a dedicated, spacious telestudio within the neurological department, while the Southern region chose PC-based systems to reduce the space requirements.quality of the treatment: Voss Hospital did not use telestroke when locum staff was on duty during holiday periods at the central hospital. Correspondingly, in the northern region, Vesterålen Hospital expected an experienced neurologist for telestroke consultations, not a resident doctor. Telemedicine networks where specialized regional or central stroke centres collaborate with local hospitals, can meet this request for expertise 24/7 [Motivation, or lack of it, has been a key issue in adapting telemedicine ,25. Thisise 24/7 ,14.At Voss Hospital, the doctors reported that it was important ‘to keep the technology warm’ and to use telestroke even when thrombolysis was not considered relevant. Regular testing and use of the equipment may be crucial for efficient use in an emergency setting. Using the VC-system for medical emergencies besides stroke, might also lower the threshold for use and thus increase the volume of telestroke.Telemedicine in connection with acute conditions has received increased attention in recent years ,19. In tToday, the boundaries between telephony and video are shifting and overlapping . Good vinot to use VC-based telestroke, but 24/7 telephone consultation and teleradiology between the central and the local hospitals in the region.In this study, we have concentrated on telestroke as a visual service (two-way sound-image) and we have not surveyed telephone-based consultation. One of the four health regions has chosen We have referred to the national quality indicator registry for thrombolysis treatment which shows regional differences in Norway. However, it is outside the scope of this paper to analyse the relationship between telestroke and thrombolysis frequency.Telestroke has been introduced in Norwegian hospitals since 2008. Few services have been operative over time and are integrated in clinical practice. Experience with telestroke is limited and divergent, and recordings are inadequate. Barriers to telestroke integration in the clinic are not attributed to the technology per se, except for the unresolved allocation of responsibility for ICT systems and networks, and the need for 24/7 technical support. Other equally important barriers are: Common and mandatory procedures for telestroke beyond questions about thrombolysis are needed. On site, the telestroke system must be placed where it is easily accessible and ready for use. Last, but not least, the motivation of staff is crucial to ensure a joint understanding of the quality assurance component of consulting colleagues by telestroke.


The relationship between humans and microbes is attracting the scientific interest since the creation of the first lens by Leeuwenhoek Fogg, . As yearChapter 1 - This chapter shows how diverse microbes are and the metabolic importance of this diversity. It describes the microbial community present in different skin areas, in the nose and lungs, in the mouth and stomach, intestines, and genitals.Chapter 2 - Describes how we acquire our first microbes from our mother and explains the agents influencing the microbial community shifts along our lives, in response to the food we eat, the contact we have with the environment and with pets, and the use of antibiotics. It ends discussing the links between microbiota diversity and health conditions, and the need for further studies in this area.Chapter 3 - Links diseases like obesity, allergies, asthma, kwashiorkor malnutrition, and irritable bowel disease to the presence or absence of specific microbial groups and the life stages when we are exposed to them. The authors use several research papers showing evidences that the microbes have an enormous impact on our health.Chapter 4 - Focuses on the influences that gut microbes have on our brain; it shows impacts on mood, behavior and/or psychological disorders. It presents several examples of experiments using mice with anxiety disorders or with induced autism, treated with probiotics and altering their gut microbiota, resulting in an alleviation of symptoms. Furthermore, the authors discuss the current state of art on the application of these treatment strategies to potentially cure human disorders. Experiments involving probiotics to help treating irritable bowel disease and celiac disease in infants are shown, and their relation to depression and several psychological effects are raised.Chapter 5 - Starts driving the reader attention to the plasticity of our microbiome and raises the possibility of manipulating and enhancing it. To discuss this subject, the authors use a lawn as example, showing its whole biodiversity and how it grows. Later on, the authors introduce concepts of prebiotics—substances that enhance and benefit our microbes, and probiotics—microbes that live in and benefit the human body. Moreover, they talk about the risks of the microbe ingestion without the proper knowledge, discuss about the benefits brought by vaccines and consider a future, where we could use vaccines for diseases like depression, anxiety or other mind disorders.Chapter 6 - Begins telling a story about the worries that people have when they think about vaccines and how comfortable they are about having antibiotics. This chapter explains the differences between these two issues, elucidating the effects on our whole microbiota and the risks of antibiotic misuse, like not having it for the corrected time, as prescribed.Chapter 7 and Appendix - makes predictions about the future of the microbiome studies and the direct benefits it can bring to people. Furthermore, it introduces the three most famous American microbiome efforts—American Gut Project, Earth Microbiome Project and the Human Microbiome Project—and invites people to have their gut microbiomes described by the former.DM and JC read the book and write the review with contributions of LR and VP. All authors approved this work for publication.JC received studentship from Fundação de Amparo à Pesquisa do Estado de Minas Gerais (FAPEMIG) and Centro de Pesquisas René Rachou (CPqRR), through the PROVOC program.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


The review examines the new approaches in modern systems biology, in terms oftheir use for a deeper understanding of the physiological adaptation of ahealthy human in extreme environments. Human physiology under extremeconditions of life, or environmental physiology, and systems biology arenatural partners. The similarities and differences between the object andmethods in systems biology, the OMICs  disciplines, and other related sciences have been studied. Thelatest data on environmental human physiology obtained using systems biologymethods are discussed. The independent achievements of systems biology instudying the adaptation of a healthy human to physical activity, includinghuman presence at high altitude, to the effects of hypoxia and oxidative stresshave been noted. A reasonable conclusion is drawn that the application of themethods and approaches used in systems biology to study the molecular patternof the adaptive mechanisms that develop in the human body during space flightcan provide valuable fundamental knowledge and fill the picture of humanmetabolic pathways. The term was first introduced by P. James in 1997, byanalogy with genomics.) appeared in the late XXth century as a set ofmethods for the large-scale study of proteins [Proteomics .Yet, despite the impressive achievements in implementing mass spectrometrytechnologies in experimental biology, the results obtained using proteomicmethods have had a lesser impact on medicine than those obtained with genomicresearch. In our opinion, this is mainly because proteomic problems are morecomplicated due to the lack of methods for the amplification of proteinmolecules similar to PCR, and also because of the fact that the amount ofproteins is much greater than that of genes (by many orders of magnitude).There are also some other complicated reasons. No doubt, such a gap betweentheory and practical application impedes the rate at which such discoveries asthe revealing of genetic functions etc. are implemented into practicalknowledge and used in clinical medicine.OMICs – collective name ofproteomics, transcriptomics, peptidomics, metabolomics and other post-genomicdisciplines.), including proteomics, has been summarized in detail in numerous reviews[The status of post-genome OMICs  by HUPO) are needed at thecurrent stage but are insufficient for a biological understanding of thephysical and functional interaction between proteins under conditions ofdynamic molecular networks, where identifying the function of specific proteinsis as important as determining the structure and function of individual proteins, 10, 17.Fourth, the technical limitations of mass spectrometry (as the main“breakthrough” tool in proteomics) in terms of the data integrityand reproducibility of peptide identification and the protein correspondencedecreases the value of the results of comparing the proteomic data obtained byvarious researchers and laboratories. As a result, specialized massspectrometry teams generate large, high-quality datasets that are difficult orsimply impossible to interpret and apply today, while the overwhelming majorityof researchers in the field of life sciences perform analyses of small sets ofproteins using methods that were developed decades ago  studies led to the discovery of 12,168 proteins of thehepatic tissue and organelles from four main types of the hepatic tissue, andthe number is expected to reach 13,000 by 2015 .CurrentThe proteins in the organism do not function alone. They form multiproteincomplexes on the one hand and complex functional and dynamic networks on the other hand-25.The In addition, since most eukaryotic proteins are multimodular and polyfunctional-30,a prProteomics and other OMICs disciplines  are not only new research tools and new measurementpossibilities. Their emergence and development have brought new meaning tosystems biology.at al. [These are the characteristics that appear in complexsystems as a result of the interaction between their components; they cannot bepredicted based on the characteristics of individual components. If theorganization of a complex system is hierarchical, the characteristics influenceeach other as “top to bottom” and “bottom to top”, 56-59.)of the system [In their review, Edwards and Thiele stated tat al. ,in fulle system , 44.One has to admit that the most fundamental difference between systems biologyand OMICs disciplines and other related sciences, such as integrativephysiology, is the central role of mathematical modeling and computertechnologies -47.It iThe genome-scale construction of the metabolic processes in a human organismwith further reconstruction, published in 2007, was named Recon 1. Recon 1The major issue confronting systems biology as concerns human physiology is tofill the gaps existing in molecular networks up to their completereconstruction.One of the methods to pinpoint the missing reactions in the reconstructingnetwork is to compare the results of model calculations with experimental data. NumerouHow are such methods helpful to a researcher studying extreme conditions ? The concept ofdisturbances plays a key role in systems biology .SystemsOnly a few scientists admit the benefit of experimental data on the influenceof physical exercises on a human organism for systems biology, 77.At Systems biology studies of environmental human physiology have been started, 47.SomThe ascent of a man to the highest mountain peaks initiated a surge of studiesin the field of the physiological outcomes of physical activity at highaltitudes. It has been established that the catabolic effects of chronicexposure to a hypoxic environment on muscles are a result of insufficientactivation of hypoxiasensitive signaling pathways and suppression of theenergy-intensive processes of protein translation .The stuThe studies of the mechanisms of oxidative stress and, more broadly, cell redoxhomeostasis have conclusively proved the dual role of reactive oxygen species(ROS) . UncontrFinally, space flight (its influence has been studied by physiologists andphysicians for more than 50 years) can be regarded as an unprecedented in thehistory of human evolution experience of adaptation of a healthy person toextreme environmental conditions.Paying tribute to the pioneers of this research in the Soviet Union , in the USA, and also in France, Germany, and Japan, we would like torefer the reader to the fundamental monographs that analyze the long-term results in this field-107.ManAdaptation of the human organism to any environmental factor is performed withthe help of proteins. For a long time, in accordance with analyticalcapabilities, working hypotheses were based on assumptions on the changes inthe concentrations of working proteins or the efficiency of their performance during adaptation. During the post-genomic era, ithas become clear that such a level of study of the adaptation mechanisms willbe followed by others: studies at the transcriptional level (i.e. the formationof a new set of functioning proteins) and studying the new protein complexesthat are formed during adaptation, along with the protein interaction networksand new reaction cascades. These studies can be conducted with the help ofsystems biology, using its analytical and bio-information approaches. There aresome needs that have been acknowledged by the community of gravitationalphysiologists but that have not been satisfied so far, such as reaching thelevel of OMICs. Glass , JackmanWe suggest that using the methods and approaches of systems biology to studythe molecular pattern of adaptive mechanisms that is the most complicated at the present stage would both yield valuableknowledge and help to fill in the gaps in the picture of human metabolicpathways; many of these gaps have not even been considered to exist. Thecommunity of systems biologists has only begun to realize this excitingperspective. The first papers devoted to changes in the proteome of body fluids(urine and blood) in astronauts after flight, 137havHigh group and individual variability in the urinary protein profile has beennoted by many scientists. We have showed that this is maintained even under thestrict conditions of model experiments . We observed the modification of theurinary proteome in healthy young men for 520 days with isolation in ahermoobject and managed to identify and characterize both the most plastic partof the low-molecular urinary subproteome and its constant component. Moreover,the proteins whose level in urine depended on the salt intake were discovered.The study of the urine proteome of astronauts allowed one to identify thestable portion of the subproteome represented by 21 proteins with differenttissue specificities and subcellular localizations. Three proteins  appear in the urine of astronauts afterlong-term flights aboard the International Space Station; the frequency oftheir detection in samples is most likely related to the impact of space flightfactors. The overloads experienced by astronauts at the initial and finalstages of the flight can also affect the protein composition of extracellularfluid.In the dry immersion model, the development of polyurea through a mechanismclose to saluresis leads to the development of physiological proteinurea andcompetitively dependent sodium reabsorption in the proximal tubule of thenephron.It is obvious that the proteins whose levels change under extreme conditionscannot be regarded as potential biomarkers of diseases, since they participateboth in the natural molecular response of an organism during adaptation to aliving environment and in the nonspecific component of a disease’spathogenesis.The collaboration between physiologists and systems biologists in studying theadaptation of healthy humans to extreme environmental conditions is deepeningand mutually beneficial. Researchers note that the application of systemsbiology methods in the field of physiological adaptation to extremeenvironments enables one to move away from the reductionist approaches andavoid paradoxes when interpreting data , 143.hypoxia refers to the phenomenon associatedwith the suppression ofThe term glycolysis during acclimatization tochronic hypoxia. It was shown that theacute phase ofhigh-altitude adaptation is accompanied by a higher bloodlevel of lactate at any period of submaximal load than undernormoxiaload, although the peak level of lactate remainsunchanged. However, inindividuals who have acclimatized tothe altitude for more than 3 weeks,a load of the sameabsolute value and a maximum load cause a smallerincrease inthe blood lactate level compared to the same physical load inindividuals in the un-acclimatized state. This phenomenon, initiallyregardedas a paradox ,suggested that ATP production in chronichypoxia, apparently, does notdepend on an increase inanaerobic glycolysis, but the production of mitochondrialATPbecomes better tuned to the hypoxic condition of the organism.Recent studies, however, have shown that the “lactateparadox” canonly be a transitional feature of hypoxicadaptation to altitude, disappearingafter more than 6 weeks,during the descent to the plains after a climbto altitudesabove 5,000 m. Moreover, the decrease in the muscle ability toproduce lactate during the period following acclimatization has notbeenshown in the studies. The question remains open as towhether the “lactateparadox” is caused by thedecrease in lactate production in muscles dueto the changesin the substrate preference or changes in lactate processingthrough the mitochondrial enzyme complexes MCT1 and MCT4(monocarboxylatetransporters 1 and 4) in muscle, or forbetter coupling of pyruvatesynthesis with oxidation takingplace in mitochondria. The questionremains to be solved,along with defining a clear profile of the conditionsunderwhich it occurs. Several authors have suggested that a phenomenonanalogous to the so-called “lactate paradox” can also occurin tissues otherthan muscles, in response to acute metabolicstress in chronic hypoxia.et al. [Now there is growing worldwide interest in collaboration between life scienceresearchers and their colleagues , which has been included in the agenda of the majororganizations that fund science. Thus, partnerships between specialists workingin the fields of systems biology/bioengineering and human physiology willbecome increasingly common. The new generation of scientists who are called towork in this field will become more transdisciplinary. We agree with thestatement by Edwards  that “noet al. , we can Thus, new approaches inherent to modern systems biology can be used for adeeper understanding of the physiological adaptation of a healthy human toextreme environments. One can certainly agree with the opinion thatenvironmental physiology and systems biology are natural partners . Studies


The lack of motivation of health workers to practice in rural areas remains a crucial problem for decision-makers, as it deprives the majority of access to health care. To solve the problem, many countries have implemented health worker retention strategies. However, the development of such strategies requires an understanding of the preferences of health workers. The objective of the study was to identify a package for attracting and retaining health workers in underserved areas.A cross sectional study was conducted in three health regions of Burkina Faso in 2012. A discrete choice experiment was used to investigate preferences for incentive packages among health workers recruited under the regionalized policy. In-depth interviews and focus group discussions with health workers currently working in the East and Sahel regions and policy makers, and a literature review on attraction and retention in low income countries, were performed to identify the attributes and levels. These attributes were: the regionalized recruitment policy, health insurance, work equipment, housing, and specific incentive compensation. The final design resulted in 16 choice sets. A multinomial logistic regression was used to determine the influence of socio-demographic characteristics on choice of a given option. A probit logistic regression model was then used to analyze the effect of these difference variables on choice, to identify the incentive package best suited to health workers. In total, questionnaires were administered to 315 regional health workers.For all participants, choice of package was strongly influenced by length of commitment under the policy and provision of housing. Sex, number of years in profession, and location also influenced the choice of package. Women are twice more likely to choose a package with free housing and the cancellation of the policy.It is important that governments consider health worker preferences in crafting policies to address attraction and retention in underserved areas. In addition, the methodology of discrete choice experiment has been particularly useful, not only for better understanding the factors explaining the reluctance of health workers to work in underserved areas, but also to provide practical advice to the government, to improve its retention policy. Most countries, particularly in sub-Saharan African, are experiencing a shortfall in health personnel. The World Health Organization (WHO) estimates that 57 countries, including 36 in sub-Saharan Africa and six in South Asia, have a cumulative shortfall of 4.3 million health care workers. This shortfall is comprised of 2.4 million doctors, nurses, and midwives, with one million on the African continent alone . In addiSeveral countries have implemented recruitment and retention policies in order to keep health care workers in rural or remote areas. In Niger, financial incentives for health personnel working in rural areas has improved the recruitment rate , while iIn Burkina Faso, a regionalized recruitment policy for nurses, midwives, and auxiliary midwives has been in place since 2003 to correct the uneven distribution of human resources.Although the factors that affect the motivation of health workers are well documented -8, thoseThe aim of our study is to determine an incentive package that can attract and retain health personnel recruited by the regionalization policy in underserved areas.This study was conducted in three health regions in Burkina Faso, which is located in French-speaking West Africa. The health human resources situation is unsatisfactory. The health worker ratios are among the lowest in the world. In 2011, the ratio of physician was 1:22 017, the ratio of nurse was 1:2 679, and the ratio of midwife was 1:12 754 .The majority of health workers are public sector employees. The government is the main job provider in the health care sector. Among health care professionals, 82% are public sector employees . In termTo ensure an equal distribution of human resources, the Ministry of Health implemented the regionalized recruitment of health workers in 2003. Within the framework of this regionalized recruitment, qualified officers who were trained at nursing schools are able to join the public service as contract workers through direct competitive selection processes organized by the Ministry of Health, for predetermined health regions. For each health region, a number of positions are identified and a call of interest is released. Before the exam, health workers are registered for a predetermined health region. Thus, after passing the exam, health workers are assigned to predetermined health regions for an unlimited time of commitment. They cannot receive an appointment out of their initial health region. They have some options to change health regions. Firstly, they could change positions with another regionalised health worker from another region. Secondly, after two years, if they are admitted to a professional competition that allows them to change professional category, they can obtain an appointment out of their initial region at the end of their new professional training. The health workers targeted by this regionalized recruitment policy are midwives, nurses, itinerant health officers, and auxiliary midwives.This is a cross-sectional study of health personnel working in the public health sector. Data was collected by six data collectors in February 2012.The sample size required to conduct a discrete choice experiment varies widely . HoweverThe sample was selected using a stratified approach. Three health regions were selected purposively. As such, the Sahel, East, and Boucle du Mouhoun regions were selected. These hard-to-reach regions are often characterized by high maternal mortality ratios, a low ratio of personnel to primary health care centre, and a reputation of being difficult according to health professionals. In addition, these health regions have the highest number of health workers recruited under the regionalized recruitment policy. Each health region is comprised of a number of health districts and a regional hospital. Two health districts were selected in each region based on the number of health officers identified through the census. The two districts with the highest number of officers were selected. In total, six health districts were selected. Each health district covers a number of health centres including several primary health centres and one district hospital. All health centres in the district were selected. In each centre, the questionnaire was administered to all health workers recruited through the regionalization program except those who were absent for sickness or on leave. In total, 315 regional health workers were included.DCE is a method that has been used in health economics since the 1990s . It was n will choose the alternative that provides the highest individual benefit or utility. The individual n will choose the alternative i from a series of choices C, comprised of several other alternatives j, if and only if the alternative i procures maximum utility U (Uin = Vin +Ԑin):DCE is an evaluation method that consists of proposing to individuals different hypothetical scenarios typical of the good or service to be evaluated. Faced with a series of hypothetical choices, the individual assigns a level of utility to each scenario presented and chooses the one that would give him maximum utility. This method is founded on the random utility model. According to Lancaster’s consumer theory , the satin > Ujn , Uin + Ԑin) > (Vjn + Ԑjn)⇔ (Vin - Vjn ) > (Ԑjn- Ԑin)⇔  is expressed as:Given that utility cannot be observed, it is, however, possible to collect the preferences of individuals from among the different alternatives proposed. It is assumed that individuals choose an alternative based on the utility it provides. Consequently, the probability that the individual n (i/C) = Pn [(Vin - Vjn ) > (Ԑjn- Ԑin)], Pn (i/C) = Pn [Ԑjn< Ԑin + (Vin - Vjn )], ⇔ PThis theory of utility requires a multiple attribute approach that consists of breaking down the examined good into its different components or attributes, to which levels (or states) they are likely to take. A monetary attribute is added, which takes into account the consumer’s budget constraints in the selection process. Breaking down the good into attributes and identifying the levels of attributes results in a process of fractional generation of experiences that consists of combining the attributes to get several scenarios. Each scenario reflects a specific state of the studied good .In this study, we first conducted a qualitative study among health professionals in the target population to identify the different attributes . In-deptThe experience construction step enabled the creation of a design that combines the different attribute levels, to identify all possible incentive packages that include health workers’ aspirations and preferences.1 x 34) possible combinations. As the possible number of combinations was too high to reasonably conduct a study, a fractional or full factorial experimental plan was generated. The Hahn and Shapiro catalogue was used to select combinations for an orthogonal main effects design, and to organize the selected profiles into the most D-efficient choice design, given our design parameters. The final design was resulted in a 16 choice sets. Respondents were then asked to select their preferred option from each of 16 choice sets (15 random and 1 fixed) or could decide to stay in their current job. They were asked to give the reason for the opt-out option and for how long the chosen option could motivate them in their current position.For the DCE, a labelled choice design with two choices in each choice set was used. The experimental plan was made up of all possible combinations, taking into account the number of attributes and levels of each attribute. The regionalized recruitment policy attribute had four levels and all other attributes had three levels. This specification resulted in a design with 324 . Women are twice as likely to choose options 2, 3, and 5 (Table 2 = 0.1636). Only the attributes related to the regionalization policy and housing are significantly associated with the preferences of health workers. The results for the regionalization policy show that implementation of a measure to establish any kind of term of practice in a region is not preferred by health professionals. The housing results show that the options containing the provision of staff housing for health workers are preferred by health officers. In summary, a health officer would be willing to stay in a rural area if the regionalization policy were cancelled and if decent housing was provided. These results are corroborated by the respondents’ preferred choice of options 2, 3, and 5, in which the regionalization policy is cancelled.Table The lack of motivation of health workers to practice in rural areas remains a crucial problem for decision-makers, as it deprives a majority of the population of access to health care. To solve the problem, a number of countries have implemented several health worker retention strategies. However, the development of such strategies requires an understanding of the preferences of health workers so that the incentive package can be as motivating as possible in order to retain them. More and more studies are using the Discrete Choice Experiment method to determine the preferences of health professionals. However, the majority of these studies were conducted in English-speaking countries, and among students.Regarding the identification of the attributes, salary increment was not identified as an attribute during the qualitative study, as it was in many studies. According to interviewed health workers, it was not realistic to suggest that. In fact, salary in Burkina Faso is based on the same scale for all civil servants, which could explain why they did not suggest a salary increment, since change in salary does not only depend on the Ministry of Health.The results of our study show that the majority of health officers choose packages that provide for the cancellation of the regionalized recruitment policy, the availability of work equipment, and the provision of housing.Housing is an important factor in health worker retention in rural areas. These results are corroborated by many studies  that have shown the importance of housing in the motivation to relocate.No less important, the availability of quality work equipment is a factor often cited as motivation for health workers. Retention strategies that include quality medical equipment have a greater influence on workers’ motivation to provide quality care .The choices of these incentive packages can be explained by the socio-demographic characteristics of seniority, region of practice, and gender. The effects of seniority can be explained by the fact that the more experience health officers have in their field, the more familiar they are with the realities and their professional prospects. Likewise, the contextual factor is determinative in the choice of packages. The contextual realities vary from one region to another, as the content of a package brings satisfaction depending on the environment in which the health officer resides. Women are twice as likely to choose packages where the regionalization policy is revoked. This choice can be explained in part by family reunification, which is an important motivating factor for women. Cancellation of the policy implies mobility, which will allow them to be reunited with their partners, children and other family. These results are supported by studies that have shown that due to family considerations, women are less motivated than men to practice in rural areas ,25. In cCancellation of the regionalization policy is a preference expressed by health officers after a few years of practice. The reason for this preference may be that initially, the health officer is seeking employment and less responsibility. Once the job has been acquired and the health officer is in contact with other officers who are not subject to the policy, the officer’s aspirations change. Family responsibilities, professional opportunities, as well as community integration, contribute to changing the health officer’s motivation to remain in a rural area.The period during which incentive packages are motivational is also important. In Mali, the medicalization policy retained doctors in rural areas for four years . The durOne of the objectives of the study was also to inform policy makers. A few weeks after the survey, health workers were on strike and one of their claims was the cancellation of the unlimited time of commitment of the policy. At the end, the Ministry of Health decided to limit the time of commitment to five years, which was one level in our policy attributes table. Currently, after five years the health worker who is recruited under the regionalised policy could have an appointment in any other region of the country.Our study has its limits. The limits of the DCE method have been extensively documented . Our curOur study shows that the cancellation of the policy and the provision of housing are important determinants in the choice of health officers to practice in rural areas. This could be a first step in the development of an incentive package. Our results also show that one uniform retention policy for health officers is not appropriate. In summary, the DCE method can facilitate the definition of incentive packages to help decision-makers develop interventions adapted to local conditions.DCE: Discrete choice experiment; DFATD: Foreign Affairs, Trade and Development Canada; GHRI: Global Health Research Initiative; IDRC: International Development Research Centre; WHO: World Health OrganizationThe authors declare that they have no competing interests.FYB, EK, and SK collaborated in the writing of the manuscript. FYB, EK, MWEY, ARB, and SK were involved in the design of the survey. FYB, EK, and MWEY were involved in the conducting of the survey. EK and ARB performed the statistical analyses. All authors revised the manuscript before submission.


Introduction: High quality of care is one of the requirements of nursing which depends on the nursing competency. In this connection, the aim of this research was to determine the problems related to the academic training  and clinical practice to achieve competency from the viewpoint of nurses, faculty members, and nursing students.Methods: the study was an analytical cross-sectional one. The sample consisted of the academic staff, the third and the fourth year nursing students and nurses in practice. The instrument of the study was a two-part researcher-made questionnaire with 22 questions in the theoretical- clinical realm to assess  problems related to the theoretical and clinical teaching in nursing, and 23 questions to assess the clinical functions. The questionnaire was validated in terms of both face and content validity. Its reliability, using Cronbach's Alpha coefficient, was 0.72 in the theoretical-clinical and 0.73 in the clinical realm. Both descriptive and analytical statistics were used to analyze the data, using SPSS software.Results: The results of this study indicated that from the participants’ viewpoints, the most important problems in the academic education for nursea to acquire competency were as follows: lack of academic research the clinical period (88.9%), no application of theoretical aspects of the nursing process in practice (85.6%), insufficient knowledgeable and professional educators (81.1%), the use of traditional routine-oriented methods on the wards (75.6%); also insufficient time for performance based on knowledge in relation to  the nurse's workload (86.5%), weakness and usefulness of scientific function encouragement systems in clinic (85.2%), and learnt theoretical subjects not coming into practice in clinical fields after graduation (75.6%).Conclusion: Efforts to reduce the gap between the theoretical and practical  knowledge in educational and work environment are required to improve the training of qualified nurses. Nowadays, providing high quality nursing care is a requirement which depends on the nursing competency. Clinical nursing competency means competence and qualification in the areas of cognitive and psycho-physical, clinical skills, critical thinking, decision making and ability to enhance learning through academic knowledge and clinical experience, leading, finally, to standards and safe care .The close relationship between clinical competency and the concepts of quality has a unique place in nursing profession as a practical profession. Some studies in Iran and other countries have shown that clinical competence of the nurses, and specially, the newly graduated nurses is far from the ideal situation , 3. IncoSo training competent nurses to preserve people’s health is consistently one of the goals of nursing education and this has drawn a greater attention to the subject of clinical qualification and competency , 6.Nurse’s education, experience, professional development, independence, personal characteristics, motivation, and work satisfaction as well as the evaluation of the quality of nursing care have been identified as factors associated with nursing competency , 7. ThesThe role of competency in education has grown dramatically as health care employers and educators have identified the gap between education and practice. The gaps between educational preparation and actual practice were attributed to factors such as lack of funding to update the nursing curricula and a limited focus on teaching in academic health centres .Cheraghi argues that there is a mutual relationship between knowledge and practice in nursing. Paradoxes in nursing knowledge and nursing practice which are seen along with diverging organizational structure reduce the ability of nurses in using professional knowledge and nursing skills .Overall, the studies demonstrated the importance of clinical environment and academic nursing education in nursing competency. Therefore, the aim of this study was to assess problems to achieve competency from the viewpoints of nurses, faculty members, and nursing students. This analytic, cross-sectional study was conducted in Gonabad University of Medical Sciences, using a census method. The sample consisted of 12 academic staff, 60 nursing students (the third and the fourth year), and 129 staff nurses working at the University hospitals. By a two-part researcher-made questionnaire the viewpoint of the participants on academic and clinical problems of competency in nursing training, in the academic teaching situation  and practical function in hospital has been assessed . There were 22 questions in theoretical-clinical realm to assess problems related to the theoretical and clinical teaching in nursing, and 23 questions to assess the problems nurses and nursing graduates were involved in in real practice from the viewpoints of the participants. The response options for each question were on a 4-point scale, ranging from completely agree to completely disagree. The responses were collapsed to two groups, agree vs disagree, in data analysis. The questionnaire was validated in terms of both face and content validity. Its reliability, using Cronbach's Alpha coefficient, was 0.72 for the theoretical-clinical and 0.73 for the clinical realm.  This study was approved by the Student Research Committee of Gonabad University of Medical Sciences. After obtaining permission from the university vice chancellor for education, the ethics committee and heads of educational hospitals, the informed consent was obtained from all participants before delivery of the questionnaire. It was explained to all participants that the data obtained would remain confidential and the results would be presented in total. We used SPSS software (version 14) to analyse the data. The Chi-square test was used to determine the relationship among variables. p≤0.05 was considered significant. The participants’ mean age was 28.18±7.32 years, ranging from 20 to 51 years. Average number of the nursing graduates and employed staff was 8.27±6.53 years. The results related to academic and clinical problems regarding nursing competency are shown in The clinical realm  problems from the viewpoints of professors, students and nurses are shown in Our aim in this study was to evaluate the educational and clinical problems to achieve competency by nurses in terms of academic staff, nursing students, and graduated nurses’ viewpoints. The findings of this study showed that the most important problem in nursing education was not applying the studies and research done in the clinical practice and this would led to non-evidence based training. Madarshahian et al. also showed that using evidence based training instead of traditional training would enhance knowledge, skill and high quality caring. As this an important factor in clinical competence, it ought to be included in nursing education .Based on this study, another important factor influencing the clinical competence was the educators’ role. Cheraghi and Salsali, also reached the same result in their studies . Baraz eValizade et al. had also put forward the challenges facing the nursing students throughout their studies such as lack of integration of knowledge and practice, failure to apply the theory  to practice, not using nursing process and scientific principles in clinical environment .Ghodsbin and Shafakhah had also mentioned the students’ dissatisfaction with the staff-students rapport and the way of instructing the theoretical and practical courses as two other obstacles in teaching clinical skills. They add that that educators’ practical and educational experience, the provision of an environment for students’ to experience clinical skills and a sense of responsibility for educators are facilitating factors . This reAccording this study, educational problems in the clinical realm included weakness and inertia of the incentive academic performance in clinic systems, lack of standard care based on nursing knowledge on the ward and lack of appropriate facilities for care based on the nursing knowledge on the ward. Nemadi et al. have also reached similar results as the least supportive elements in the clinic from the nursing graduates such as lack of support from colleagues and administrators in improving knowledge and clinical skills . MirzabeCheraghi also maintains that there is a mutual relationship between knowledge and practice in nursing. Paradoxes in nursing knowledge and nursing practice which are seen along with diverging organizational structure reduce the ability of nurses in using professional knowledge and nursing skills. These factors are effective in creating a gap between theory and practice . Maben eThis cross-sectional study was done in an Iranian Medical University. So the results may not be generalized. This study investigated problems in achieving nursing competency in training programs from the participants’ viewpoint. The gap between the theory and practice was an important finding. Practical-orientation and traditional view of educators, students and nurses about clinical competency based on practical skills reduced the need of practice based on knowledge and research.  Efforts to reduce the gap between the theory- practice in educational and work environment are needed to improve training of qualified nurses. Also education of professionalism and action based on work environment may be useful.


Background. The determination of the safety profile of any vaccine is critical to its widespread use in any population. In addition, the application of international guidelines to fit local context could be a challenging but important step toward obtaining quality safety data.Methods. In clinical studies of PsA-TT (MenAfriVac), safety was monitored immediately after vaccination, at 4–7 days for postimmunization local and systemic reactions, within 28 days for adverse events, and throughout the duration of study for serious adverse events. Initial and ongoing training of sites' staff were undertaken during the studies, and a data and safety monitoring board reviewed all the data during and after the studies.Results. The safety of PsA-TT was evaluated according to international standards despite obvious challenges in remote areas where these studies were conducted. These challenges included the need for uniformity of methods, timely reporting in the context of frequent communication problems, occurrence of seasonal diseases such as malaria and rotavirus diarrhea, and healthcare systems that required improvement.Conclusions. The trials of PsA-TT highlighted the value of a robust vaccine development plan and design so that lessons learned in initial studies were incorporated into the subsequent ones, initial training and periodic retraining, strict monitoring of all procedures, and continuous channel of communication with all stakeholders that enabled the application of international requirements to local settings, with high quality of data. Determination of the safety profile of any vaccine or drug is crucial before its routine utilization in the community, as drugs that show a safe profile in animal studies can show a different effect in humans . ApproprHaemophilus influenzae type b (Hib) conjugate, there were reports of occurrence of Guillain-Barré syndrome (GBS) [Following the introduction of me (GBS) , 8. In ame (GBS) . Althougme (GBS) , comparime (GBS) , 11. TakEight clinical trials were conducted in groups ranging from 14 weeks to 29 years of age, in 5 countries  during the clinical development of PsA-TT. These trials were double-blind randomized controlled studies designed to allow adequate comparison of the safety profile of PsA-TT with that of 2 licensed vaccines; some of the results have been reported elsewhere .Neisseria meningitidis infections occur across various regions and cultures with heterogeneous characteristics. In the design of the safety component of the trials of PsA-TT, uniform system and harmonized procedures were used to collect the data, while making allowance for peculiarities in each of the settings where the studies were done. This was necessary to ease combination of the data sets and comparison of specific characteristics between groups as the trials took place in several areas with cultural and geographic variations. These trials also complied with the Good Clinical Practice (GCP) standard and other international regulatory requirements.Group A Across all the trials, safety assessments were done at specified time points as per standard operating procedures (SOPs) from the sponsors and the sites.The purpose of this was to detect any adverse reactions that occur immediately after administration of the study vaccine. Subjects were observed before the vaccination and then after vaccination for between 30 minutes and 60 minutes. During this period, subjects were assessed for any AE or any immediate hypersensitivity reaction. The injection site was also examined for any local reaction such as induration or tenderness.Participants were visited daily for 4 days  to document any systemic or local reaction. The follow-up on day 4 (or 7) was done by a medical doctor. A consistent method of soliciting systemic reactions was used, and the participants or their caregivers were asked nonleading questions. Any solicited systemic reactions were recorded, and the injection site was examined to document any local reaction such as tenderness and induration. Study staff assessed the intensity of the tenderness using a priori–defined grading criteria. The size of any induration and temperature were also measured.Untoward medical occurrences were recorded from the date of vaccine administration until 28 days following vaccination. The diagnosis, date of onset, intensity, and treatment given were recorded. As much as possible, these AEs were defined in terms of diagnosis, but if this was not possible, symptomatic AEs were documented. Medical doctors assessed the causality of AEs based on priori–defined criteria (see below).As per International Conference on Harmonisation (ICH) guidelines , a serioBefore the start of the PsA-TT studies, it was decided that any solicited event elicited within the first 4 (or 7) days after vaccination would be regarded as an adverse reaction—that is, they would be assumed to be caused by study vaccines. This decision eases the difficulty that might occur in assigning causality immediately after the study vaccine was given, but is mindful of the fact that many may not be related to the study vaccine. The assessment of causality for other AEs or SAEs was based on 3 defined considerations: the temporal relationship of the event to the time the study vaccine was given; the possibility of other obvious causes; and the previous AE experience of the study vaccine or other similar conjugate vaccines as specified in the Investigator's Brochure. In all PsA-TT trials, conforming to current practice in clinical development, only 2 grades were used for the assessment of causality: related and unrelated.A very important component of the AE and SAE monitoring was the rigor taken in training all those involved in the studies. Trainings included basic GCP training, training on the protocol and SOPs, and practically verified training on procedures. Nurses and field workers received bedside training on identification of common clinical signs, assessment of intensity, and measurement of dimensions of local reactions. Physicians were also trained to ensure uniformity in the ascertainment of clinical signs and assigning causality. In some studies, parents and subjects were trained to document AEs. These trainings were done at the beginning of each study, and at specified milestones—for instance, after recruitment of a specified percentage of the sample size. There were also in-built, ongoing, on-the-job trainings through periodic monthly or fortnightly business meetings and person-to-person interaction. Data on error rate and common errors were regularly generated at the study sites to facilitate these trainings.A simple reporting system of AEs and SAEs Figure  was emplDuring the earlier phases of the PsA-TT trials, SAEs were reported with handwritten forms. As the studies progressed, to comply with the Council for International Organizations of Medical Sciences reporting system , recordiTo ensure the collection of valid data, there was a culture of monitoring from the field sites up to the level of the DSMB. Investigators monitored one another to ensure the accuracy, completeness of AE forms, and also timeliness of the SAE reporting. SAE reports were checked for accuracy and compliance with the protocol by the responsible CRO. A different CRO performed periodic monitoring visits to the study sites, where they compared the source documents with what was recorded on the SAE report forms and/or case report forms, to reconcile any discrepancy. The frequency of the visits was determined by the nature of the study and the quantity of data to be monitored. The sponsors also employed the services of an experienced safety consultant who helped set up the SAE system and during the course of studies clarified terms and important dates and resolved differences in understanding.A DSMB of 3–4 experts was set up prior to initiation of each PsA-TT clinical trial in accordance with GCP requirements and the DSMB charter. These comprised distinguished epidemiologists, pediatricians, and a respected lay member of the community. For each study, there was a mixture of international and local experts. The group conducted face-to-face meetings or telephone conferences, and thoroughly assessed the data during the course of each study, providing the sponsors with overall review of the study to ensure adequate protection of study subjects. The board reviewed SAE reports and all AEs at specified intervals and advised the sponsors on any concerns in relation to the vaccine safety, in addition to making appropriate recommendations. Important safety-related activities or study participants’ health issues were reviewed with the DSMB, and the advice was taken into consideration in decisions related to these issues.Early on in the clinical development, it was noted that understanding of issues and SOP items varied across trial sites. This was not surprising, considering the wide cultural differences in the different places where the studies took place. Efforts were made to harmonize these differences so as not to jeopardize subjects’ health. Periodic meetings were set up between the sites and sponsors; sites and CRO; and sites, CRO, and sponsors to discuss any misunderstanding, misinterpretation, and challenges to ensure a common understanding and practice. When necessary, further trainings were organized at the sites to improve the understanding and implementation of specific aspects of the SOP. Also during the course of each trial, meetings were set up to clarify issues such as SAE onset date, end date, and any issue with the reporting system. Each of the different collaborators could trigger a meeting, although sponsors bore the overall responsibility for ensuring that safety activities in the trials were done to international standards.Because harmonized understanding and ascertainment procedures for safety assessment were crucial in view of diverse cultural, linguistic, and religious environments, extra efforts were made to meet this standard. Much effort was invested in ensuring uniform translations of the study documents and understanding by study workers. Close monitoring of the data collected helped to detect misunderstanding , which was tackled by further training, demonstration, and the development of a field manual for a “ballpoint” measuring technique . SimilarIt is common practice in some of our study sites to give children antipyretics before or following immunization. As this may have an impact on the immune responses following immunization , 17, effThe studies were performed in rural, suburban, and urban environments with varying communication challenges such as unreliable email network, phone outage, and time differences. There were in-built plans to communicate both internally for the study and with external collaborators and agencies. SOPs clearly specified what to do depending on the circumstance. Study staff used telephone to communicate with subjects or their parent/guardian, and for reporting of AEs to responsible staff. Responsible staff used either email or fax or telephone to report SAEs to the CRO, the sponsors, or the relevant review boards. When email or fax did not work, SAE reports were first communicated by telephone, and the copy was sent as soon as the appropriate communication line was reestablished. Timelines were followed, and any lateness was addressed by the designated coordinator. To ensure that timelines could be kept, minimum information for initial reporting was required as defined by ICH GCP; this included subject identity, the reporter, time of vaccination, date, and description of event with preliminary assessment of severity and causality. Follow-up reports were generated when new information became available. To ensure effectiveness, timelines for conclusions of SAE reports were specified, and every effort was made to stick to these timelines. Lists were generated regularly as a reminder for pending SAE reports and/or summary SAE narratives.PsA-TT clinical trials had to comply with different approval and reporting systems in sub-Saharan African countries and India in line with GCP. Approval was sought from various regulatory bodies, local ethics review committees, and institutional review boards of partner institutions. As expected, the requirements for these committees varied, and the studies had to work hard to harmonize diversities. For instance, although some committees were satisfied with monthly summary reports, some committees requested an expedited reporting of all SAEs, whether related or not related to the study vaccine, in addition to the monthly summary reports. This unusual directive was particularly challenging to the study site, more so when receipt of most of these transmissions was not acknowledged by the regulatory body. However, every effort was made to comply with them.PsA-TT clinical trials were conducted in rural areas and cities with varying degrees of functional health systems. One of the important questions in conduct of clinical trials in developing countries is what type of medical care should be given to study subjects . Should In some study sites, a peculiar health system operated that had the use of traditional medications, homeopathic therapy, and orthodox drugs accepted officially. Due to the confidence that many of people from developing countries place in traditional medicines, at times it was difficult to control their use or even to know what medicine a subject actually received. In certain situations, different types of therapy were given together to a study subject. In other situations, the subjects took these themselves, even after receiving the drugs prescribed by study staff. All possible efforts were made to document this and to code with WHO Drug Dictionary.The so-called African meningitis belt, which stretches from Dakar in the west to Ethiopia in the east, is also an endemic malaria environment . MalariaAt a site where one of the infant studies was conducted, October to February is a known rotavirus diarrhea season. As rotavirus is the commonest cause of diarrhea in infants, there were a number of SAEs of acute watery diarrhea. Fortunately, during the same period, there was ongoing rotavirus surveillance, and this helped to confirm rotavirus infection in most of these cases.Pregnant and lactating women constitute an important group in the community. According to ICH guidelines, pregnant women should be excluded from clinical trials where the drug is not intended for use in pregnancy . The guiPsA-TT (MenAfriVac) has now been given postlicensure to >217 million people aged 1–29 years ; hence, Rigorous procedures as required by GCP standards were followed in all the clinical studies to monitor the safety of PsA-TT as well as to ensure safety of the study participants. The following key lessons were learned in the process: (1) It is important to have a robust vaccine development plan and design so that lessons learned in initial studies can be incorporated into subsequent studies; (2) initial training, but crucially also periodic retraining, of all study staff on the protocol and the SOPs is important; (3) strict monitoring of procedures, documentation, and reporting are very beneficial to evaluate the safety of a new vaccine; and (4) a continuous channel of communication with all stakeholders enables the application of international requirements to local settings, with appropriate quality.


Although it is widely accepted that lack of capacity is one of the barriers to scaling up nutrition in West Africa, there is a paucity of information about what capacities exist and the capacities that need to be developed to accelerate progress toward improved nutrition outcomes in the region.To systematically assess the current capacity to act in nutrition in the West Africa region and explore cross-country similarities and differences.Data were collected from 13 West African countries through interviews with government officials, key development partners, tertiary-level training institutions, and health professional schools. The assessment was based on a conceptual framework of four interdependent levels . In each of the surveyed countries, we assessed capacity assets and gaps at individual, organizational, and systemic levels.Important similarities and differences in capacity assets and gaps emerged across all the surveyed countries. There was strong momentum to improve nutrition in nearly all the surveyed countries. Most of the countries had a set of policies on nutrition in place and had set up multisectoral, multi-stakeholder platforms to coordinate nutrition activities, although much remained to be done to improve the effectiveness of these platforms. Many initiatives aimed to reduce undernutrition were ongoing in the region, but there did not seem to be clear coordination between them. Insufficient financial resources to implement nutrition activities were a major problem in all countries. The bulk of financial allocations for nutrition was provided by development partners, even though some countries, such as Niger, Nigeria, and Senegal, had a national budget line for nutrition. Sporadic stock-outs of nutrition supplies were reported in most of the countries as a result of a weak logistic and supply chain system. They also had a critical shortage of skilled nutrition professionals. There was limited supervision of nutrition activities, especially at lower levels. Nigeria and Ghana emerged as the countries with the greatest capacities to support the expansion of a nutrition workforce, although a significant proportion of their trained nutritionists were not employed in the nutrition sector. None of the countries had in place a unified nutrition information system that could guide decision-making processes across the different sectors.There is an urgent need for a shift toward wider reforms for nutrition capacity development in the West Africa region. Addressing these unmet needs is a critical first step toward improved capacity for action in nutrition in the region. Undernutrition remains a major public health concern in West Africa, where the prevalence of child stunting is one of the highest in the world and childhood underweight is the leading risk factor for disability and premature deaths . MoreoveThere is currently strong momentum to accelerate progress toward improved nutrition outcomes in West Africa. With the exception of Cape Verde, all countries in the West Africa region have now signed up to the Scaling Up Nutrition (SUN) movement. This provides a unique opportunity to improve overall nutrition governance in the region. However, political commitment is likely to be short-lived if it is not translated into tangible actions which address the major impediments to the implementation of nutrition interventions . It is wAlthough it is widely accepted that there is an urgent need to develop capacities for nutrition in West Africa, there is a paucity of information about what capacities exist and what capacities need to be developed to accelerate progress toward improved nutrition outcomes. Moreover, little has been done to strengthen nutrition capacity at organizational and systemic levels. Previous capacity development efforts have mainly focused on strengthening human capacity for nutrition. Contrary to a common belief, capacity development goes beyond the training of individuals . It encoThe World Health Organization has conducted a landscape analysis of the capacity to scale up nutrition actions in some West African countries , 10. HowThis paper presents a systematic assessment of the current capacity of West African countries to act in nutrition. It explores cross-country similarities and differences in capacity assets and gaps.This qualitative study is part of a larger capacity needs assessment conducted in the West Africa region. The assessment was conducted within the framework of the WANCDI implemented under the auspices of WAHO.Anglophone countries Francophone countries Lusophone countries (Cape Verde and Guinea-Bissau).The West Africa region was defined according to the United Nations country classifications . It has Data were collected in 13 of the 16 West African countries between March and August 2013. We did not conduct field visits in three countries  because our preliminary contacts with in-country key informants revealed that tertiary-level nutrition training activities were either non-existent or were not well-developed. Data were collected by three experienced interviewers through self-administered questionnaires or face-to-face interviews during country visits. Data were completed  by the interviewers in the presence of respondents during in-person meetings. Completed self-administered questionnaires were emailed to the research team. Interviews were not audio or videotaped, so data transcription was not performed.Interviews with government officials in charge of nutrition: A semi-structured questionnaire (available upon request) was administered to the nutrition focal person in each of the surveyed countries to explore the three interdependent levels  of nutrition capacity development. The questionnaire was structured around four key elements: workforce planning and leadership, management of workforce, work environment, and human resources.Interviews with key stakeholders involved in nutrition: Data were also collected from other sources to support the findings from discussions with government officials. Interviews were conducted in each of the surveyed countries with key stakeholders, namely non-governmental organizations, United Nations (UN) agencies, and donors. A strengths, weaknesses, opportunities, and threats (SWOT) analysis was conducted with all stakeholders.Interviews with nutrition training institutions and health professional schools: We conducted a detailed inventory of the current capacity for nutrition training in each of the surveyed countries. Data were collected using a semi-structured questionnaire that was either administrated during face-to-face discussion or self-administrated by tertiary-level training institutions offering nutrition degree programs. Health professional schools offering nutrition courses as part of their training curricula were also interviewed. Information was collected on the content and status of nutrition courses; profile of faculty members; students and graduates; funding; facilities; prevailing teaching methods; school ownership; institutional affiliation; main funding source; and institutional collaborations. Details about this inventory have been described elsewhere .Country presentations from the ECOWAS nutrition meeting: Data were also collected during the ECOWAS nutrition forum mid-term review meeting held in Monrovia, Liberia, 26–27 November 2013. The workshop was organized by WAHO and was attended by the nutrition focal points of all the surveyed countries. Data were also gathered from country presentations made by the nutrition focal points during the meeting.Literature review and internet searches: Besides the interviews, we did a comprehensive literature review that looked beyond individual training needs and focused on previous reports addressing nutrition capacity development in West Africa. We also checked several web portals, including the SUN movement website .Data for this assessment were derived from five main sources:Data were entered into Microsoft Excel 2010. They were analyzed and interpreted using content analysis. We used the analytical framework developed by Potter and Brough  to systeAdministrative authorization was sought by sending a formal correspondence to the head of all of the targeted institutions prior to data collection. We did not seek ethical approval for the study as there was no data collection on human subjects. All respondents were fully informed about the purposes of the study. They gave their full verbal consent before participating in the study.In the 13 surveyed countries, semi-structured interviews were conducted with 44 government officials and 51 stakeholders, namely representatives of non-governmental organizations, UN agencies, and donors . We idenWe report the findings relating to logistics, information management, funding, and the quality of nutrition training. In all the 13 surveyed countries, nutrition service providers, in general, had the needed equipment  and supplies to perform nutrition-related tasks, although they were not available everywhere or at all service delivery points. Equipment and nutrition supplies  were mainly provided by development partners. Concerted efforts had been made to ensure the availability of these nutrition products at all service delivery points. Sporadic stock-outs of nutrition supplies were reported in most of the countries as a result of a weak logistic and supply chain system, poor forecasting of nutrition supplies at lower levels, and inadequate transportation systems. As of the time of our study, development partners were playing a strong role in the procurement and distribution of these nutrition supplies.A common challenge for all 13 countries was the scarcity of financial resources for nutrition activities . AlthougAnother common observation was the difficulty in getting accurate information about nutrition financing. The fact that resources come from various sources and cut across many sectors made it difficult to track investments and expenditures on nutrition. In Ghana for example, each government unit carrying out nutrition activities had its own budget that was often embedded in a higher level budgetary category. Efforts were underway in most of the countries to improve clarity in overall nutrition budgeting. In Ghana, a sub-committee on resource mobilization had been established, within the Cross-Sectoral Planning Group (CSPG) of the national SUN movement secretariat, to track resource allocation for nutrition in the country.Inadequate human resources for nutrition were a major barrier to the implementation of nutrition activities . In all In the absence of a critical mass of skilled nutrition professionals, the bulk of nutrition work was done by health workers who did not have a good understanding of the application of nutrition principles to public health or clinical practice. As a result, they did not have broad enough skills to provide quality nutrition services. We noted that some countries were taking steps to enhance the performance of health workers through in-service training and mentoring in nutrition. However, these efforts were mainly oriented toward the management of acute malnutrition. In addition, continuing training efforts were mainly concentrated on staff at national and regional levels, leaving staff at lower levels with inadequate capacities in nutrition.The results on capacity at the organizational level relate to the production of human resources, staff placement, and supervision. A common characteristic for all the surveyed countries was a critical shortage of nutritionists . AlthougIn all the surveyed countries, training institutions supporting the development of nutrition workforce faced many challenges with teaching resources. They were poorly staffed, financially constrained, and had weak research capacity. They lacked teaching materials and equipment, infrastructure, libraries, and access to advanced technology resources. In most of the countries, there did not seem to be a coordinated effort toward interactions between academia, policy makers, and program managers. As a result, nutrition training institutions operated in silos and rarely participated in policy development or service delivery.The countries also differed significantly in their approach with regard to staff placement . AlthougMost of the countries faced challenges in supervising nutrition activities at lower levels. We noted that supportive supervision and mentoring on the job were not systematically or widely carried out. There was limited monitoring because of inadequate logistics and funding. All countries agreed that the provision of additional means of transport would enhance supervision and thereby strengthen program implementation.The results on capacity at systemic level relate to governance, coordination mechanisms, and information management. There was strong momentum to improve nutrition in most of the countries. This was illustrated by the existence of a set of policies and plans on nutrition, which are used to prioritize actions and track progress toward the achievement of stated objectives . HoweverMost of the countries had also set up national multisectoral, multi-stakeholder platforms that brought together all the major stakeholders in the nutrition area. These platforms offered the opportunity to share lessons and best practices, as well as to reduce duplication of efforts. Their location differed in the surveyed countries. In Benin for example, the coordinating body was placed directly under the Office of the President, whereas it was within the Prime Minister's office in Niger and Senegal. Ghana and Mauritania had set up a separate government body that oversaw nutrition activities at national level. The Ministry of Health continued to coordinate nutrition activities in Burkina Faso, Cote d'Ivoire, Liberia, Mali, and Nigeria. Cote d'Ivoire and Liberia were, however, taking steps to establish, within the framework of their involvement in the SUN movement, a multisectoral, multi-stakeholder coordination mechanism for nutrition activities. Other new initiatives aimed at improving nutrition security were also ongoing in the surveyed countries. The Renewed Efforts Against Child Hunger and undernutrition (REACH) had also gained momentum in five countries in West Africa . The European Union and other development partners had also launched the Global Alliance for Resilience Initiative (AGIR).A common weakness in all countries was the lack of or inadequate coordination mechanisms at lower levels. The cross-disciplinary nature of nutrition made it difficult to coordinate nutrition activities, leading to a high degree of fragmentation of nutrition activities across several ministries, departments, and agencies. In Ghana, coordination at the national, regional, and district levels was being strengthened, institutionalized, and empowered to enhance their effectiveness. Countries such as Benin, Burkina Faso, and Nigeria were taking steps to strengthen the coordination of nutrition activities at their policy and operational levels.The vast majority of the surveyed countries had made considerable efforts to strengthen the nutrition data collection system. Nutrition surveys, using the SMART methodology, were now being conducted on a regular basis in most of the countries and the survey results were being used for decision-making. Nutrition data were also generated through Demographic and Health Surveys (DHS) or Multiple Indicator Cluster Surveys (MICS). Despite these advancements, there were still some unmet needs. None of the countries had as yet succeeded in putting in place a single, multisectoral information system for nutrition that will guide decision-making processes across the different sectors . In addiIn our region-wide assessment of the current capacity to act in nutrition in West Africa, we analyzed key capacity assets and gaps as well as cross-country similarities and differences. Our findings reveal that important efforts have been made over the past years to raise the profile of nutrition to a high priority in the surveyed countries. The nutrition landscape has been evolving in most of the countries in West Africa since 2011. In addition, advocacy efforts are underway to sustain this momentum and keep governments involved. This is a positive move toward the achievement of nutrition-related MDGs in the region. Donors and development partners have also played an important role in this process. The different nutrition initiatives supported by development partners  have greatly contributed to the advancement of nutrition in the region.Despite these positive developments, there are still some challenges and unmet needs. There is a need for clear divisions of tasks between ongoing nutrition initiatives. For example, five of the 13 surveyed countries  are both SUN and REACH countries. It is critical to ensure good coordination between these two important initiatives as both aim to support country-led processes to improve nutrition governance and enable multisectoral, multi-stakeholders approach to addressing undernutrition , 16. ThiOur findings also indicate that lack of funding is a major barrier for the implementation of nutrition activities. There is indeed a clear disconnect between national nutrition goals and the resources available for the implementation of nutrition activities. This situation slows the translation of governments’ commitments for nutrition into tangible actions on the ground. We found a high dependency on donor resources for nutrition activities as a result of low government investments. It is critical that governments in the West Africa region take on greater responsibility for nutrition financing.Another major challenge that was common was the inability to track investments and expenditures on nutrition activities. The importance of having accurate information on nutrition financing cannot be overemphasized. These data are not only crucial for planning purposes (to make projections for nutrition financing), but are also vital in identifying financial gaps and ensuring efficiency and accountability. There is an urgent need to improve the systems for tracking allocations and expenditures for nutrition activities in the surveyed countries. The workshop on costing and tracking investments in nutrition, co-organized by UNICEF and the SUN movement secretariat in Nairobi, Kenya, in November 2013 , was a pThe results of our study indicate that shortage of skilled human resources to deliver nutrition interventions is a major problem in all countries. There is a clear need to support the expansion of the nutrition workforce in the region and provide incentives for nutrition service providers to stay in service. Training institutions should be empowered to support the expansion of the nutrition workforce. In addition, attention should be paid to the pre-service and in-service training in nutrition of health professionals. Our findings also indicate that there is a lack of regulation of the nutrition profession. The need to set a minimum standard to qualify as a nutritionist in the region has been previously stressed , 20. It Overall, our data are consistent with findings in previous studies in some of the West African countries , 10. TheIt is not our intention in this paper to make specific recommendations on how to develop capacity for nutrition in the West Africa region. We believe that this should be done in a participatory manner, with the involvement of all stakeholders. For instance, we are planning to convene a regional workshop to discuss the findings from this study and build consensus on the way forward. The ultimate goal of this workshop would be to create a unified discourse between stakeholders on how to strengthen the capacity to act in nutrition in the West Africa region. This will ultimately lead to the development of a consensual regional capacity development strategy that will help shape future nutrition actions.Our study has several limitations. It was difficult to obtain quantitative data on financial investments in nutrition as they were not readily available in the surveyed countries. In addition, we did not have the opportunity to assess the adequacy of infrastructure for nutrition services through direct observations. Given the rapidly evolving nutrition environment in West Africa, it is possible that some of the information reported in this paper may not fully reflect the current situation on the ground. However, we believe that our study provides a comprehensive view on the current capacity to act in nutrition in the West Africa region.Nutrition programs in West Africa are characterized by a critical shortage of skilled human resources, limited funding, high dependency on donor resources, weak logistic and infrastructure systems, and lack of supervision as well as coordination of nutrition activities at lower levels. These factors hamper the ability to act in nutrition in the West Africa region. Addressing these unmet needs is critical in moving toward improved nutrition outcomes in the region. There is an urgent need for a shift toward wider reforms for nutrition capacity development in the West Africa region.