Outcome measurement in forensic mental health services can support service improvement, research, and patient progress evaluation. This systematic review aims to identify instruments available for use as outcome measures in this field and assess the evidence for the most common instruments, specific to the forensic context, which cover multiple outcome domains.Studies were identified by searching seven online databases. Additional searches were then performed for 10 selected instruments to identify additional information on their psychometric properties. Instrument manuals and gray literature was reviewed for information about instrument development and content validity. The quality of evidence for psychometric properties was summarized for each instrument based on the COnsensus-based Standards for health Measurement INstruments (COSMIN) approach.A total of 435 different instruments or variants were identified. Psychometric information on the 10 selected instruments was extracted from 103 studies. All 10 instruments had a clinician reported component with only two having patient reported scales. Half of the instruments were primarily focused on risk. No instrument demonstrated adequate psychometric properties in all eight COSMIN categories assessed. Only one instrument, the Camberwell Assessment of Need: Forensic Version, had adequate evidence for its development and content validity. The most evidence was for construct validity, while none was identified for construct stability between groups.Despite the large number of instruments potentially available, evidence for their use as outcome measures in forensic mental health services is limited. Future research and instrument development should involve patients and carers to ensure adequate content validity. Forensic mental health services provide care for people with mental illness who pose a risk to others and have typically perpetrated acts of violence or other antisocial behaviors . The strMeasuring the outcomes of forensic mental health services is complicated. Unlike most other healthcare services which focus exclusively on improving outcomes for patients, forensic mental health services also have the dual purpose of public protection. In many jurisdictions this is considered their primary, if not sole, purpose. In other forensic mental health systems however, there is an increasing recognition that patient-centered outcomes must also be prioritized ,12. PrevPolicy programs are increasingly concerned with measuring outcomes across health services ,23. DrivPrevious reviews of outcome measures in forensic settings have identified a large number of questionnaire-based instruments in clinical practice and research settings ,29. ThesThe present study seeks to update the evidence base, as previous reviews were completed almost a decade ago or only consider a small subset of measures . It aimsWe report this review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting items, adapting where appropriate for this type of study . We follWe searched seven databases  from database inception until spring 2018 using a combination of terms including “tool”; “instrument”; “scale”; “outcome”; “recovery”; “risk”; “rehabilitation”; “quality of life”; “symptom”; “forensic”; “secure”; “unit”; “ward”; and “hospital”. See Supplementary Material 1 for an example of the full search strategy.We reviewed the titles and abstracts of identified records. Included papers needed to describe the use of relevant instruments in a forensic mental health setting. The full text had to be available in English. All types of empirical or review paper were included. Papers describing use in prison or general psychiatric services only were excluded. Papers describing assessments of personality, which are generally not dynamic, and competency to stand trial and malingering, which are outcomes related to the legal process, rather than treatment response, were also excluded.Papers meeting the screening criteria were reviewed in full text to identify relevant instruments described within. The format, type of study and geographical location were recorded. The frequency each instrument or subvariant appeared was noted. To determine the 10 most frequently appearing instruments, counts for all subvariants of each instrument were summed. We then considered each instrument, starting with the most frequently identified, to determine which met the criteria of being both multidimensional and designed for use in a forensic mental health context, until we had identified the 10 most frequently occurring within the literature. Multidimensional instruments included items on more than one of the four domains identified in previous reviews in this field  ,16. ForeWe conducted additional searches for each of the 10 selected instruments. We searched the PubMed database using common variants of each instrument’s name combined with the COSMIN filter of psychometric terms . We reviWe developed a data extraction tool, based on the COSMIN systematic review protocol and risk of bias tool. A number of adaptations to the standard approach were necessary, as the identified instruments were predominantly clinician reported. Content validity focused on the qualitative comprehensiveness and relevance of items in relation to the concept of interest, while all other psychometric properties were assessed using quantitative studies of numerical scores generated by the instruments. Quantitative data were extracted on seven psychometric properties . According to COSMIN, the dimensionality of a scale should be determined by factor analysis before internal consistency is considered . In thisWe assigned an overall rating to the strength of evidence available for each of the seven psychometric properties for each instrument based on all included studies in one of three categories. For properties with adequate evidence of good performance we assigned the highest category. Properties with either inadequate evidence of good measurement properties or evidence of inadequate measurement properties were assigned to the middle category. Those properties with no evidence were assigned to the lowest category.We used the same categorization system for content validity, including the instrument development process. However, due to the lack of published studies, we used a qualitative synthesis of information available from a range of sources, including instrument manuals and other gray literature, based on the COSMIN methodology for assessing content validity, which focuses on establishing relevance and comprehensiveness in the target population .n = 247) were studies of the psychometric properties of instruments, while only 3% (n = 17) concerned interventional trials. Almost half  originated in the UK and Ireland (see Supplementary for a full description of the studies reviewed in full text).The initial screening process identified 4,494 unique references, of which 502 met the inclusion criteria for full text review. Four hundred and fifty-six (91%) were articles in scientific journals. Almost half . The most frequently occurring instrument within the literature was the Historical, Clinical, Risk 20 (HCR-20) , which aThere was considerable variation in the format and stated purpose of the selected instruments. This included assessments of progress, risk factors, protective factors, patient need, and clinical decision aids.Half of the 10 instruments assessed were developed primarily as risk assessments  –42. Two Eighty-six (17%) of the references identified by the review strategy contained relevant data on the psychometric properties of the 10 selected instruments. An extra 29 references were identified through the additional search techniques described in Step 4 of the methods see . See SupAll 10 selected instruments had some evidence of empirical processes to support their development, however, this often emphasized quantitative reviews of the literature on risk factors for violence, rather than considering the views of relevant stakeholders . When thThe degree of evidence for the remaining psychometric properties was mixed, with evidence on testing hypotheses for construct validity identified for every instrument, but none for measurement invariance . EvidencNine instruments had some evidence for their reliability, which focused primarily on interrater, rather than test–retest reliability. Measurement error had limited evidence with studies identified for three instruments –50. The This systematic review aimed to provide an overview of instruments currently available for use as outcome measures in forensic mental health services. A broad definition of what constitutes an outcome measure ensured a wide range of instruments were considered. The review focused on instruments which are clinically relevant, to increase applicability of findings to real world settings. It assesses the quality of evidence for the 10 most frequently occurring instruments within the literature, which are also multidimensional and forensic specific. This review was based on a recognized quality assessment process and, to our knowledge, this is the first time that such a systematic approach has been applied in this field . This quOverall, the evidence for the appropriateness of the selected instruments as broad outcome measures is limited see . At leasThe differing attention to various aspects of validity and reliability in the quality assessment reflects the original purposes of the instruments. For example, as an assessment of patient need, the CANFOR has a much greater focus on content validity, while the HCR-20, as a risk assessment, focuses more on prediction of negative outcomes ,57. StudThe COSMIN guidelines emphasize the need for outcome measures to demonstrate adequate stakeholder involvement in their development . Even foOverall, the evidence for the other psychometric properties of the instruments as outcome measures is limited, with numerous gaps in the published research. This lack of a comprehensive evidence base is perhaps surprising given the age and popularity of many of these instruments, but may reflect the diversity of their intended uses. Adequate evidence for other uses, such as risk predication, may be well established, but does not necessarily support their use as outcome measures. Further research should seek to ensure that the identified gaps in the evidence base are addressed, if these instruments are used as outcome measures. Certain properties, such as measurement error and measurement invariance are almost entirely overlooked, so should be considered in future studies. Evidence for other fundamental characteristics, such as structural validity, is also often absent or inadequate.The ability to detect change over time was explicitly considered in the review under the category of responsiveness. While seven instruments had some evidence for responsiveness, this property was only deemed adequate for the VRS and SAPROF. Demonstrating reliable change in this population can be challenging, due to the long timescales involved . AdmissiAuthorship bias has been identified as a potential problem in the literature on risk assessments in the forensic context . While aNew instruments are needed for forensic mental health services to enable clinicians and patients to report and measure individual and service outcomes. These should be developed according to the latest best practice guidelines, including the participation of relevant stakeholders, such as clinicians and patients ,63. DeveThis review identified many instruments that have been, or could be, used as outcome measures in forensic mental health services. These vary considerably in format, content, length, stated purpose, and evidence base. Of the 10 instruments reviewed in detail, only HoNOS-Secure is designed with the sole primary purpose of measuring progress, although other instruments such as the VRS and LS/CMI are also intended to assess change over time . The wayMost instruments identified in this review are reported by clinicians only. For instruments that do include a patient reported scale, these scales may have been designed after the development of the clinician reported ones, with limited patient input ,65. ThisComprehensiveness is an essential quality for outcome measures . While rGiven the very large number of instruments identified, it was only possible to assess the quality of evidence for a small proportion of them. Some of the included instruments were not intended to be used as outcome measures, and their utility is not limited to this. A frequency based approach was chosen to select instruments for the quality assessment. This was deemed the most systematic method of identifying instruments that were likely to have a sufficient evidence base to judge their qualities against the COSMIN criteria. There may be instruments that did not meet our selection criteria that have the potential to perform well against the COSMIN criteria, when sufficient evidence is available. The use of frequency of appearance in the literature to select instruments for quality assessment has a number of drawbacks. Firstly, older tools are likely to appear in more published studies, simply by virtue of being in existence for longer. Secondly, some studies were published as multiple papers, meaning that a limited evidence base generates a disproportionate number of references. Thirdly, although we grouped variants of instruments together, there may be important differences between variants. Finally, all types of paper were included in the count and the proportion of studies that contained psychometric information on a particular instrument varied, so the overall count does not necessarily reflect the quantity of psychometric evidence available.Language was a limitation in two ways. Firstly, the search was limited to those references where the full text was available in English. Secondly, studies involving translations of instruments were included, although evidence from a translated version may not always apply directly to the English version, due to subtle cultural and linguistic differences .Assessing the quality of instrument development and content validity studies according to the full COSMIN criteria proved challenging ,35. The Although there are a large number of instruments available that can be used as outcome measures in forensic mental health services, the evidence base for their use in this way is limited. Despite recommendations from previous reviews, instruments that appear most frequently in the literature remain focused on risk and fail to adequately involve all stakeholders, especially patients ,16. Repu


There is strong evidence that engaging with music can improve our health and well-being. Music-based interventions, approaches and practices, such as group music-making , listening to music and music therapy, have all been shown to reduce symptoms of depression and anxiety. Although the existing literature needs expanding, mounting evidence suggests that music-based interventions, approaches and practices may help support maternal mental health prenatally and postnatally. The purpose of this descriptive overview is to provide a broad view of this area by bringing together examples of research across different practices and research disciplines. Selected evidence is examined, showing how music-based interventions, approaches and practices can reduce labour anxiety and pain, anxiety symptoms in pregnancy, postnatal depression symptoms and support maternal-infant bonding. The examined research includes single studies and reviews that use both qualitative and quantitative methods. Drawing on animal and human models, the effect of music on foetal behaviour and various possible biological, psychological and social mechanisms are discussed. The potential preventive effect of music-based interventions, approaches and practices and their possible use across different cultures are also considered. Overall, we highlight how music, employed in a variety of ways, may support perinatal mental health with the aim of stimulating more interest and research in this area. In their review, Wulff et al. , researchers investigated the effects of listening to relaxing music, versus participation in a singing class led by a music therapist, compared with treatment as usual on maternal well-being and mother–infant bonding , where a music-based approach might be particularly useful as it is non-stigmatising, low-cost and can be culturally embedded. In a recent feasibility study in The Gambia, West Africa, has been carried out (Sanfilippo et al. In conclusion, there is considerable evidence, albeit of varying quality, that music-based interventions, approaches and practices can support perinatal mental health in a variety of ways, including by helping reduce anxiety and pain during labour, anxiety symptoms during pregnancy and symptoms of postnatal depression. Music-based interventions, approaches and practices, especially those which involve infant-directed singing have also shown potential benefits for supporting mother–infant bonding. Potential biological, psychological and social mechanisms, including those related to the psychoneuroimmunological effects of music and the social effects of group music-making, have recently been investigated in perinatal populations. There has also been discussion around the potential preventative effect of these types of interventions and approaches, although, as of yet, very little research has been conducted. Co-developed interventions, which capitalise on existing music practices, may be especially applicable in places that have rich musical traditions but few trained mental health professions. They present a culturally-embedded, non-stigmatising and low-cost intervention to support maternal mental health. Overall, this overview presented a selected set of examples of research from a variety of disciplines with the aim of stimulating future investigation into music-based interventions, approaches and practices that support perinatal mental health.


Evidence-based practice in medicine and social policy relies heavily on evidence synthesis. To translate evidence into practical guidelines for low- and middle-income countries, local expertise is essential. The objectives of this study are to assess the change in capacity for conducting evidence synthesis in Africa and to identify key African institutions for regional capacity-building. We take on a network perspective, considering that the position of an institution in the African evidence ecosystem is one constituent of its research capacity.We systematically identified 3548 evidence synthesis publications between 2008 and 2019 with at least one author in Africa from the Web of Science Core Collection. These articles involved 3769 institutions. Longitudinal institution-level collaboration network data were constructed based on co-authorship information. We used social network analysis to examine the institutions’ connectivity and tendency for intra- and interregional collaboration. We also identified the degree- and betweenness-central African institutions and explored the structure and composition of their local network neighbourhoods.The number of African institutions involved in evidence synthesis has increased substantially over the last decade, from 31 in 2008 to 521 in 2019, and so has the number of evidence synthesis publications with authors in Africa. African institutions in the evidence ecosystem have also become more connected during this period. Although the amount of intercontinental collaboration continues to exceed that of regional collaboration, the tendency for African institutions to collaborate with partners in Africa is increasing. We identified seven institutions—in South Africa, Egypt and Uganda—as central to the collaboration networks between 2008 and 2019, all of whom showed a tendency to collaborate across sectors.The development of more regionally based network-building initiatives would help to foster communities of practice and inter-institutional collaboration, strengthening regional research capacity. Moreover, the analysis in this study adds depth beyond a simple bibliometric analysis and illustrates that network analysis could provide a useful tool to evaluate the effectiveness of capacity-building strategies and programmes in the future. With the dramatic increase in academic publishing rates over the past three decades, the clear synthesis of research outcomes has become increasingly important. Evidence synthesis is essential for those outside academia, as it translates results from primary studies to policy-relevant information. For example, systematic reviews can help physicians practice evidence-based medicine  and can While this proliferation of evidence synthesis has largely been driven by researchers in North America and Europe, there is a need to increase the production of evidence synthesis by researchers and institutions in low- and middle-income countries (LMICs) . KnowledThe Africa Evidence Network conducted a survey in 2017 to assess the growing capacity for evidence synthesis in Africa building on the work of Oliver et al. . They foIn Africa, significant work has been done in the past decade to orient regional policy-making toward evidence-based approaches and to lift barriers to the production and use of research evidence –13. For Connecting people is an aim many of the initiatives mentioned above share. Various global development initiatives  have established organizational networks to improve the production and uptake of evidence synthesis and communication between decision-makers and researchers. These evidence networks have been argued to create better understanding, increased capacity, and greater potential for change, and thus to lead to better decision-making . In the Collaboration networks, as measured by co-authorship on scientific papers, depict a rough image of the distribution of social capital in a research field. They have been used to study the growth in research and development of research capacity in LMICs in various areas  the collaboration network connectivity, (2) the level of collaboration of African institutions within and outside Africa, as motivated by the arguments of Boshoff , and (3)We evaluated the development of collaboration on evidence synthesis in Africa between 2008 and 2019 based on co-authorship information from published evidence syntheses that include at least one author affiliated with an African institution. Since we are interested in the development of evidence synthesis capacity of institutions over time, we chose to examine collaboration at the institutional level, rather than the author level. We used social network analysis to study the evidence synthesis collaborations, treating institutions as network nodes which are connected when they share the authorship of a paper , 25.Data were obtained from the Web of Science Core Collection. Given the proliferation of evidence synthesis methods beyond systematic reviews in the last two decades , we searThe search yielded a total of 3648 records, with 51 records removed because they had no affiliation to African countries . The final data set contains 3597 publications and includes studies across disciplinary domains. Approximately 80% of the papers are related to health sciences and medical research (as indicated by the Web of Science research area), as evidence synthesis remains primarily a method used in these fields.For each of the extracted evidence synthesis articles, we recorded the title, authors and the authors’ affiliations for analyses in the statistical software environment R (v3.6.2) . We cleaBased on the 2008 to 2019 co-authorship data, we created institutional-level collaboration networks using the igraph  package Institutions are included in all networks after their first evidence synthesis publication, as from then on we consider them part of the evidence synthesis research system. However, the 2603 institutions that published only in a single year are left out in later years, as they did not play a significant role in the research system. Leaving these institutions out does not substantially affect the results of the analyses discussed below. Forty-nine publications involving more than 20 authors were also excluded, because such collaborations likely do not reflect strong relations between institutions, and for these large collaborations, it is unclear how a publication reflects the evidence synthesis capacity of the institutions involved.After conducting a detailed, country-level analysis of the change in number of institutions involved in evidence synthesis in Africa between 2008 and 2019, and their research output in this field, we studied the evolution of the networks of collaboration on evidence synthesis.Social network analysis provides tools to examine how closely nodes in a network are connected. A detailed description of the measures discussed in this section, as well as other measures of connectivity, can be found in . To measand the average path length within the LCC is small, this indicates that the research community is strongly integrated. Moreover, to examine the influence of non-African institutions on the connectivity of African institutions, we analysed these two measures for both the collaboration networks including and excluding the non-African institutions.Note that even if a network is composed of a single component, it can still show low connectivity.E and I denote the total number of external and internal ties, respectively. In the context of this study, the E-I index is a measure for across-region collaboration. The possible values for this index range from To understand the role of intercontinental collaboration in evidence synthesis in Africa, we identified the collaborations across and within regions for the 10 networks between 2008 and 2019. We refer to collaborative ties between institutions in different regions—in this case, between African and non-African institutions—as external ties. Internal ties are collaborative ties between institutions in the same region. A classical measure of the dominance of external over internal ties (or heterophily) is the E-I index by Krackhardt and Stern , which iregionalization index. The regionalization index The E-I index is a network-level index. However, since we are primarily interested in the collaboration trends of African institutions, we here propose a group-level variation on the E-I index: the The regionalization index is an adaptation of the nationalization index of Binz, Truffer and Coenen , which dThe regionalization index has a more intuitive interpretation: it is 0 if institutions collaborate on average an equal amount with institutions within and outside Africa.v is defined ass and t, and v [v. The betweenness centrality of a node indicates to what extent it serves as a “bridge” between other nodes.To identify institutions that play an important role in the collaboration networks, we calculated the degree and betweenness centrality for all institutions. The degree centrality of a node in a network is defined as the number of edges of that node. Institutions with a high degree centrality—that is, with a large number of collaborative ties—are referred to as “hubs”. The betweenness centrality of a node h node v . The sumAlthough betweenness and degree centrality scores are often correlated (nodes with many ties have more chances to serve as a bridge), nodes with high betweenness centrality do not necessarily have high degree centrality. For example, when an institution links to one institution in each of two otherwise disconnected clusters, its degree centrality is only two, but its betweenness centrality is very high.Degree centrality and betweenness centrality are naturally dependent on network size . Given that nodes in larger networks have more opportunities for connections, the centrality scores of central nodes in large networks are likely to be larger than those of central nodes in smaller networks. Since the collaboration networks we consider here grow in size over time, we also calculated the normalized degree and betweenness centrality scores for each institution, which divide the  centrality score by the maximum centrality score possible for a node in a network with the same number of nodes.3After computing the degree and betweenness centrality scores for all institutions, we identified all African institutions that ranked top three among the African institutions in either of the centrality measures in any of the collaboration networks between 2008–2009 and 2018–2019. We refer to these institutions as the (most) central institutions and analysed how their centrality scores, as well as their numbers of publications, changed over time.Finally, we constructed the local network neighbourhoods  of the most central African institutions based on the 2018–2019 network. The local neighbourhood of an institution is composed of the collaborators of that institution, together with the ties among the collaborators. To understand the kinds of other institutions the central institutions collaborate with, we examined the region and sector  of the institutions in their local network neighbourhoods.Between 2008 and 2019, a total of 3597 evidence synthesis publications appeared, on which at least one individual from an African institution collaborated. These publications involve 4181 institutions from 154 countries. The number of institutions involved per paper ranged between 1 and 103. We excluded the 49 publications (1.4%) with more than 20 authors from further analysis   and greaWe used network analysis to delve deeper into the structure and characteristics of evidence synthesis collaboration in Africa and between African and non-African institutions. We examined the connectivity of the network over time as an indication of the flow of knowledge, expertise and resources between institutions. In addition to growing numbers of collaboration on evidence synthesis, we found increasing integration of the evidence synthesis research community, suggesting greater capacity for knowledge diffusion and resource sharing across institutions. The 2008–2009 network in Fig. To further assess the role of collaboration with non-African institutions in evidence synthesis, we used the E-I index  and propWe used network analysis to highlight institutions that hold central network positions based on both production and collaboration measures. Central institutions contribute to the stability of the network, help connect organizations on the periphery and serve as conduits of knowledge, resources and expertise . Thus, iThe consistently central position of the South African universities in this network reflects a combination of significant investment in research compared to other countries in the region , and a nCairo University and Assiut University in Egypt also held central roles in the network. However, likely due to the economic impacts of the Egyptian Revolution in 2011 , their pMakerere University in Uganda appears with a high betweenness central ranking, particularly from 2011 to 2013, indicating that it acted as a bridge between otherwise disconnected institutions. It has been found that having larger collaboration networks and collaborating with otherwise disconnected peers is correlated with more novel and highly cited research output . At an iFor central institutions in our network, we examined the diversity of sectors represented in their local collaboration networks based on collaborations in 2018–2019, as well as the degree to which they are collaborating with regional partners Fig. . Cairo UOur study relied solely on data from Web of Science. While this database provides thorough multidisciplinary coverage, it may not fully reflect the landscape of African publications, particularly those published in regional journals not indexed in mainstream databases or evidence syntheses not published in the formal peer-reviewed literature. Other databases could be searched to include broader coverage, but many insufficiently capture affiliation data for such an analysis. We also did not do an exhaustive search for all known evidence synthesis methods, but rather relied on our knowledge of the evidence synthesis publishing landscape to search for the most common forms of this type of research. We believe that the addition of other, less common evidence synthesis types would not have had much impact on the results, but this could be explored in future work.In addition, we assumed that the publication of a systematic review or other form of evidence synthesis is a reflection of the capacity of all authors for conducting evidence synthesis. While the contribution of individual authors is not known, and the quality or impact of publications was not considered, we believe our analysis should reflect overall trends at an institutional level and thus can serve as a proxy for institutional capacity.We also recognize that the current work lacks authorship-level contribution from Africa-based researchers. Thus, the results were interpreted based on the authors’ knowledge of co-authorship network analysis, and experience in collaborating on evidence synthesis with international teams and working with colleagues at African institutions to develop and conduct evidence synthesis training programmes. However, the paper lacks the expertise of those deeply familiar with the African research context. While this does not invalidate the results, it may have impacted the depth of interpretation.While we focused on institutions with high degree centrality as potential targets for capacity-building, those engaging in evidence synthesis on the periphery of the network could provide an interesting focus for future research and for investment in capacity-building programmes. Another avenue for future research is the disciplinary differences in evidence synthesis collaboration. Evidence synthesis has increased across disciplines in recent years , and capIn addition, research on the motivations and incentives for collaboration on evidence synthesis, and associated barriers, could provide greater insight for capacity-building strategies. Funders are known to drive the makeup of collaborations, for example, in requirements for interdisciplinary teams or the inclusion of top-tier research institutions , 52. GenOur study indicates that substantial opportunity exists for leveraging existing knowledge of evidence synthesis methods in African institutions and improving regional capacity. Efforts to facilitate local and regional collaborations, train domain experts and methods specialists, and increase sustained access to funding and resources should be key elements of capacity-building programmes.In the context of evidence synthesis, the incentives to publish and collaborate with researchers in the Global North likely continue to outweigh those to collaborate with researchers in other LMICs. Access to research databases and the journal content necessary to carry out comprehensive reviews in addition to funding, publishing opportunities, and high-profile research partnerships are all factors that likely influence decisions to collaborate on evidence synthesis. Despite the dominance of non-African collaborations in our network, collaborations within Africa are also increasing. We note potential for intra-African collaboration on evidence synthesis and an opportunity to build capacity from within, for evidence synthesis relevant to the African context. Initiatives that increase incentives and opportunities for regional collaboration, as well as enable access to necessary resources such as journal content and funding, would serve to strengthen the regional network and build capacity for regionally relevant evidence synthesis.We found little evidence of collaboration with government agencies in these networks. Initiatives to develop more partnerships between universities and government agencies could help inform more policy-relevant evidence synthesis. That said, stakeholder engagement may not be adequately reflected in authorship, and more research is needed to understand the role of government actors in evidence synthesis production. Moreover, further analysis would be needed to determine what is driving these differences in local collaboration networks.Oliver et al.  carried In this study, we used social network analysis to assess the changes in the network of co-authorship on evidence synthesis publications between 2008 and 2019 to shed light on the capacity of African institutions to conduct evidence syntheses and the distribution of social capital within this network. We found the collaboration network to be increasingly connected, with greater involvement of African institutions over time and increasing collaboration amongst African institutions. The network perspective on research capacity in this study revealed key roles played by institutions like Makarere University in Uganda and the University of the Witwatersrand in South Africa in bridging otherwise disconnected institutions and establishing diverse collaborations—findings a simple bibliometric analysis of publication output would have missed. This analysis also complements survey methods, which can elucidate barriers and facilitators to research capacity and highlight the role of stakeholders not reflected in publication authorship. Given the value of regional and cross-sectoral collaboration in building vibrant evidence ecosystems, network analysis could provide a useful tool to evaluate the effectiveness of capacity-building strategies and programmes in the future, as illustrated by this study.Additional file 1. Additional figure and tables.Additional file 2. Dataset.


Dr Andreas Karas presents the key clinical data for this new antibiotic for MDR Gram-negative infections, followed by reflections from Professor Jonathan Edgeworth on the potential use of the new agent in UK clinical practice. Included in the latter is a case study example of a compassionate use case using cefiderocol.  This article is part of a promotional Supplement developed and sponsored by Shionogi B.V. The accompanying video formed part of an educational webinar for which the author received a speaking honorarium. The material underwent peer review by the Supplement Editors. Editorial assistance to Shionogi Europe was provided by Page Medical. J.E. received personal fees for the preparation of this article.JAC-AMR Online.The video transcript is available as dlab053_Supplementary_DataClick here for additional data file.


Biogenic amines (BAs) can be found in a wide range of meat and meat products, where they are important as an index for product stability and quality, but also for their impact on public health. This review analyzes the scientific evidence gathered so far on the presence and role of biogenic amines in meat and meat products, also considering the effect of technological conditions on BAs accumulation or decrease. The data provided can be useful for developing solutions to control BAs formation during the shelf-life, for example by novel starters for dry cured products, as well as by packaging technologies and materials for fresh meats. Further research, whose trends are reviewed in this paper, will fill the knowledge gaps, and allow us to protect such perishable products along the distribution chain and in the home environment. Biogenic amines (BAs) are low molecular weight compounds with biological activity, produced by the decarboxylation of amino acids or amination and transamination of aldehydes and ketones during the metabolic processes in living cells . They caBAs are also considered an index of food spoilage, as high concentrations can be found when the hygiene quality of the product decreases . The mosEscherichia, Klebsiella, Citrobacter, Proteus, Shigella, and Salmonella) belonging to the Enterobacteriaceae family, as well as some Micrococcaceae (Staphylococcus and Micrococcus genera) can be involved in BA production Moreover, some strains of lactic acid bacteria (LAB) of genera Enterococcus, Lactobacillus, Carnobacterium, Pediococcus, Lactococcus, and Leuconostoc can decarboxylate amino acids [Several factors associated with raw materials, such as pH and chemical composition, as well as some handling and manufacturing operations  but also temperature and time of storage, may influence their presence in foods . The corno acids .Meat and meat products are particularly subjected to BAs production due to their high protein and amino acid content, and the proteolytic activity can arise as a consequence of a prolonged storage or in association with the production process. The first BAs naturally occurring in fresh meat are SPM and SPD, which can be found at levels between 20 and 60 mg/kg and about 10 mg/kg, respectively . During Proteolysis is favored by intrinsic factors, such as acidity increase, dehydration, and the action of sodium chloride in some meat derived products, but also by microbial activity during fermentation and/or other food production processes . AlthougIt is well known that fermented meat products generally show the highest BAs concentrations, and TYR is the most represented amine in cured meat products. However, according to the European Legislation (Commission Regulation EC No 2073/2005 and further amendments), maximum limits have been established only for HIS in fish and fish products, specifically in fish with high free histidine content in the muscle tissue, while no standards or guidelines are reported for meat products. With regards to the export of these products to Third Countries, specific agreements are set between the competent authorities of European Union (EU) Member States and the nations where they are destined. Meat and meat products can only enter in EU if they have been produced from raw materials obtained in establishments compliant with the requirements referred to Regulation (EC) No 853/2004, or with requirements recognized to be at least equivalent thereto.This review will deal with BAs occurrence in raw meat and meat products produced by several manufacturing processes, whose role in BAs formation is discussed, taking into account both food quality and safety aspects, as well as the trend in scientific research.The finding of BAs in meat dates back to 1887, when Nencki discovered amylamine in putrefying meat . Early sAt the turn of the millennium, the attention shifted onto the role of starters in the balance of BAs in fermented meats. These studies can be considered a turning point because particular attention was paid to the selection of starters capable of reducing the content of BAs of health interest, for example by exploiting amino oxidase activity of specific microorganisms, as well as by combining starters with proteolytic strains to increase the free amino acid availability and the non-protein nitrogen . In the Rosmarinus officinalis essential oil, which sharply decreased PUT, CAD and HIS, and the corresponding microbial producers in fresh meat at 4 °C. Miller et al. [Based on the scientific targets documented so far in the scientific literature, it is possible to predict future trends in the research on BAs in meats. Almost certainly, the great shift in the formulation of packaging materials, imposed in Europe by the so-called Green Deal approach, will impact research on new materials capable of detecting or reducing the BAs content in foods. In this respect, some papers have already been published. For example, Sirocchi et al.  developer et al.  have recAmong the possible technologies that might be used to decrease the BAs content in meats, ozone was studied by Mercogliano et al. . These aOther possible developments of research will be in the area of microbial cultures for meat and meat products. Considering the increasing interest for the manufacturing of nitrite-free meat products, the results obtained recently by Li et al.  can be cFinally, a strategic area of research will probably be the development of sensors for BAs assessment in meat, to evaluate meat freshness and shelf-life. In this respect, Biesuz and Magnaghi  recentlyMeat ensures a complete set of amino acids, energy, lipids, and micronutrients at more competitive prices than other sources . OverallRed meats were classified as “probably carcinogenic to humans”, and processed meats as “carcinogenic”, but they are also in charge of non-transmissible diseases as overweight and obesity ; at any In raw meat, the presence of Bas depends on different factors, in particular meat origin, storage conditions, the specific microbiota, and meat shelf-life. Despite Bas ubiquity, their production is influenced by microbial activity and food history. In general, wrong hygiene and storage conditions can increase the incidence of Bas . Among t2 MAP better preserved chicken breast fillets from the accumulation of Bas (mainly PUT and CAD), in comparison with air and vacuum-packed breast fillets. The same study pointed out the importance of storage conditions since product stability was higher in cold rooms and dry conditions, than in display cases exposed to light. The prevalence of specific microbial groups has also been found to enhance Bas production. Li et al. [Alessandroni et al.  highlighi et al.  studied i et al. . Li et ai et al.  found iti et al. .Regarding the functions of BAs in raw meat, it has to be noted that raw meats mostly contain polyamines PUT, SPD, and SPM, in particular the last two. These are also known as constitutive amines because they are involved in many bodily functions having a fundamental role in cellular communication and proliferation . Due to Considering the great availability of polyamines in raw meat, many researchers proposed the use of a ratio between SPM and SPD for raw meat quality evaluation . The maiAll these studies clearly show how BAs evolution in raw meat is a suitable and helpful tool for monitoring meat safety and predict meat quality. In this regard, Wojnowski et al.  developeBAs can be found in a wide range of meat products, as documented by scientific literature . General2 absence can promote the specific production of amines as HIS while reducing the amounts of PUT and CAD, directly acting on specific bacteria as Enterobacter cloacae and Klebsiella pneumoniae [+ ion in the sodium/proton antiport system, through which H+ ions are removed from the cell [More than cured or formulated products, fermented meat products represent a primary source of BAs. Due to their manufacturing process, they possess all the characteristics that favor BAs production, mainly due to the bacterial and fungal activities. In fact, microorganisms take advantage of the available nutrients, the favorable water activity (at the beginning of the process), and the anaerobic conditions ensured by the environment. The total or partial Oeumoniae . In thiseumoniae . Anothereumoniae  reportedthe cell ,94. Furtthe cell .Enterobacteriaceae, lactic acid bacteria (LAB), Brochothrix thermosphacta, pseudomonads and some clostridia. Obviously, storage conditions and the gaseous composition of the environment have a direct influence on the final ecology, enhancing specific groups [Enterobacteriaceae and pseudomonads, some strains belonging to the genera Staphylococcus and Bacillus, and LAB [In fermented meat products, different microbial groups, intentionally added (starter cultures) or part of the natural microbiome , can proc groups . Main ba and LAB . Ferment and LAB ; similar and LAB . TYR and and LAB ,100. Man and LAB ,101,102  and LAB . Alves e and LAB , analyziLactobacillus, Pediococcus, Micrococcus, as well as Staphylococcus carnosus. Apart for the direct toxicologic effects that BAs can provoke, in the last years concerns about their involvement into N-nitroso compounds production are coming up. These toxic compounds are formed from nitrogenous compounds deriving from bacterial fermentation and proteolysis. Among them, nitrosamines are recognized as carcinogenic and highly responsible for gastrointestinal tumors [A growing part of scientific literature analyzes how specific bacterial consortia can limit or degrade BAs formation . Alvarezl tumors . Considel tumors  found thl tumors  gave an l tumors  found thl tumors , the conl tumors ,111.Heat treatments do not affect the BAs concentration in meat products, although they contrast microbial spoilage. Thus, the occurrence of BAs in cooked meats indicates an incorrect handling before and after product preparation. Recently, the effects of various cooking methods  on BAs content were investigated in different foods; Muñoz-Esparza et al.  demonstrp < 0.05) was found in the BAs profile among the different meat species . In relation to baby food products containing beef, it was recommended to reduce their consumption by infants under 12 months of age, due to the occurrence of HIS at a high level (400 ng/g).Another aspect of great importance is the assessment of the risk for infants of BAs intake with the consumption of ready-to-eat meat baby products. For the first time, Polish researchers presented a study on the amine-related risk assessment for baby foods, including meat-based formulations . No signBAs are present at various concentrations in meat and meat products. Despite their significance for both public health and meat shelf-life, there is a lack of knowledge on levels that could be used as guidelines in the different products that are available on the market. To date, the only BA that is regulated, at least in the European Union, is HIS, but only for fish and fish products. Since the International Agency for Research on Cancer (IARC) classified red meat as probably carcinogenic to humans, also due to the risk of nitrosamine formation, the research on BAs in meat and meat products has become increasingly important.In the last twenty years, the scientific literature has provided evidence of different solutions that could be applied to reduce BAs formation in meat and meat products. Packaging, starters, and decontamination by means of different technologies have already proved to be useful, but much more needs to be done to protect the products along the distribution chain, and possibly in households. This goal might be achieved by investing in research on sensors and packaging, to offer cheap and easy-to-use devices for rapid BAs assessment in meat and meat products.


It is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of a new medical device prior to the widespread adoption of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. Even though dozens of organizations perform HTAs, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA. Thus, there are considerable discrepancies in the methodologies among HTAs such that the same device with the same underlying clinical evidence is often endorsed by one agency but not another, leading to inconsistencies in healthcare coverage policy decisions. Here, we propose a more simplified and unified approach for summarizing clinical effectiveness and safety outcomes for HTAs. We developed a short, semi-quantitative scoring tool that can be used to provide an overall evaluation of evidence strength in HTAs consisting of five categories: (a) the number of randomized controlled trials (RCTs) that have been performed using the technology, (b) the risk of bias among RCTs, (c) the effect size observed for the key effectiveness outcome, (d) the effect size observed for the key safety outcome, and (e) the generalizability of outcomes observed in RCTs to those observed in real-world clinical use. Utilization of this simplified semi-quantitative framework may simplify the HTA process and improve the consistency of the resulting recommendations. Innovation in medical device development drives advances in healthcare. New medical devices may target a new clinical indication, improve safety and/or effectiveness compared to the existing standard of care, or offer cost savings to patients or healthcare payers. Prior to the widespread adoption of any new medical device, it is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve the utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. To provide an evidence-based approach to technology evaluation, researchers undertaking an HTA must specify the policy question in terms of safety, effectiveness, and economic aspects in a manner that can be answered by a systematic evaluation of the scientific evidence. Recommendations provided by HTA organizations are increasingly used to inform coverage policy decisions by healthcare payers. Therefore, it is imperative that the methods underlying an HTA for a particular medical device should be as transparent and reproducible as possible.Evaluation of health technology assessment criteria and methodsIn the absence of a universally recognized HTA process, dozens of third-party organizations perform HTAs that are commissioned by governments, medical device manufacturers, or healthcare payers to guide healthcare policy decision-making. Some of these HTAs include Emergency Care Research Institute, National Institute for Health and Care Excellence, Hayes, and Evidence Street, among others. Interestingly, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA. Thus, there are considerable discrepancies in the methodologies among HTAs Table . These dSimplified approach for reporting rapid health technology assessmentWe developed a short, semi-quantitative scoring tool that can be used to provide an overall evaluation of evidence strength in HTAs Table . The tooCategory 1: Number of Randomized Controlled TrialsRCTs represent the highest level of clinical evidence because they are designed to be unbiased and with less risk of systematic design limitations. Further, because clinical results can vary widely from one study to another, data derived from multiple studies provide more reliable evidence than from single studies. Therefore, for purposes of scoring category 1 of the HTA scoring tool, medical devices that have been evaluated in at least two RCTs receive a score of +1, medical devices that have been evaluated in a single RCT receive a score of 0, and medical devices for which no RCTs have been performed receive a score of -1. Importantly, scores are assigned regardless of the number of available noncontrolled studies as evidence derived from these sources is prone to multiple sources of bias.Category 2: Risk of Bias Among Randomized Controlled TrialsThe methods by which RCTs are performed are prone to bias from various sources such as randomization methodology, failure of allocation sequence concealment, baseline imbalances in patient characteristics, and substantial missing outcome data, among others. Given the risk of systematic errors in RCT results due to such biases, the risk of bias appraisal is now a standard reporting item for meta-analyses . As suchCategory 3: EffectivenessCategory 3 utilizes the results of a meta-analysis of the key effectiveness outcome to assign points. To facilitate clinical interpretation of the meta-analysis results for endpoints measured on a continuous scale, the treatment effects are transformed to standardized minimal clinically important difference (MCID) units ,3, whereCategory 4: SafetyCategory 4 evaluates the key safety outcome and is scored identically as effectiveness, depending on whether the outcome is scored on a continuous or binary scale.Category 5: Comparability of Outcomes in Randomized Controlled Trials to Real-World EvidenceThe generalizability of the RCT data can be compared to data derived from nonrandomized studies to determine whether similar results are attained. This element of the scoring tool is not easily determined with statistical analyses. Instead, it is recommended to qualitatively evaluate the strength and direction of the treatment effect for effectiveness and safety outcomes. If the results from RCTs and non-RCTs both suggest similar outcomes, then 1 point is assigned. If the results of this analysis are indeterminate, then 0 point is assigned. If no RCTs have been performed or if the results from RCTs are distinctly different from those derived from non-RCTs, then -1 point is assigned.Example of simplified approaches for reporting health technology assessmentsThe Barricaid Annular Closure Device  is a Food and Drug Administration-approved intervertebral biomechanical device that consists of a woven polyethylene terephthalate (PET) flexible fabric component that attaches to a titanium alloy Ti-6Al-4V ELI) intravertebral bone anchor [V ELI intIn a systematic review with meta-analysis of RCTs and non-RCTs of this device , it was The development and adoption of health technology are increasingly influenced by regulators, healthcare payers, clinicians, patients, and government leaders who demand rigorous scientific evidence to support policy decisions. The proliferation of HTA methods continues to evolve and is becoming increasingly diverse as many organizations now have their own HTA units. Given the vast differences in HTA methodologies, there is a need for a simplified HTA scoring tool that can be completed quickly and reliably.In recent years, the demand for HTA by healthcare decision-makers has increasingly involved requests for faster responses to help provide timely decisions. This has led to the development of rapid HTAs . While rThere are several advantages of using this approach. First, the framework utilizes a simple 11-point scoring scale which should enhance interpretability as a positive score suggests favorable overall evidence and a negative score suggests unfavorable overall evidence. Second, several of the scoring assessments are based on quantitative information such as the number of RCTs, risk ratios, and other statistical metrics, which should facilitate high interrater scoring consistency. Finally, a simplified, semi-quantitative scoring model might help to minimize one of the primary limitations of HTA, namely, the issue whereby HTA bodies that evaluate the same set of evidence may derive vastly different conclusions and recommendations. To the extent that dozens of HTA bodies currently exist and all use different assessment criteria, a paradigm shift towards more simplified reporting and transparent decision-making based on quantitative summary statistics may remove bias and subjectivity from HTA decisions.There are also several limitations of our proposed approach. This abbreviated methodology may not capture the full complexity of the underlying clinical data, and refinements may be needed to adequately handle special circumstances that may be specific to certain technologies. Numerous additional factors weigh into a comprehensive HTA appraisal such as the regulatory status of a product, cost-effectiveness of the data, existing societal guidelines, funding sources, and study sample size, among others. These additional factors are certainly intended to be added as supportive information, which would be considered in conjunction with the grading from the 11-point scoring scale. Additionally, the interrater agreement of our semi-quantitative scoring tool remains unclear. However, in theory, it may be higher than with current approaches that use disparate and mainly qualitative assessment methods. Finally, this simplified model does not consider the cost-utility of medical technologies. A number of HTA organizations attempt to formulate recommendations based on the collective effectiveness, safety, and cost-utility of the evidence. We argue that safety, effectiveness, and cost-utility should be evaluated in separate stages. That is, if the risk-to-benefit balance of a medical technology is deemed unfavorable based on effectiveness/safety data, it would be futile to additionally perform cost-utility studies. We, therefore, propose a simplified approach for the assessment of effectiveness/safety in this paper. Based on the risk-to-benefit profile established at this stage, subsequent cost-utility analyses would be warranted, which are beyond the scope of the current paper.Recommendations provided by HTA organizations are increasingly used to inform coverage policy decisions by healthcare payers. However, the same health technology is often assessed by different HTA agencies, often deriving different recommendations due to differences in HTA methodologies. A simplification of these methods, whereby a semi-quantitative effectiveness/safety scoring tool is used, may help to simplify and standardize the HTA process.


Waterborne diseases account for 1.5 million deaths a year globally, particularly affecting children in low-income households in subtropical areas. It is one of the most enduring and economically devastating biological hazards in our society today. The World Health Organization Health Emergency and Disaster Risk Management  Framework highlights the importance of primary prevention against biological hazards across all levels of society. The framework encourages multi-sectoral coordination and lessons sharing for community risk resilience. A narrative review, conducted in March 2021, identified 88 English-language articles published between January 2000 and March 2021 examining water, sanitation, and hygiene primary prevention interventions against waterborne diseases in resource-poor settings. The literature identified eight main interventions implemented at personal, household and community levels. The strength of evidence, the enabling factors, barriers, co-benefits, and alternative measures were reviewed for each intervention. There is an array of evidence available across each intervention, with strong evidence supporting the effectiveness of water treatment and safe household water storage. Studies show that at personal and household levels, interventions are effective when applied together. Furthermore, water and waste management will have a compounding impact on vector-borne diseases. Mitigation against waterborne diseases require coordinated, multi-sectoral governance, such as building sanitation infrastructure and streamlined waste management. The review showed research gaps relating to evidence-based alternative interventions for resource-poor settings and showed discrepancies in definitions of various interventions amongst research institutions, creating challenges in the direct comparison of results across studies. Escherichia coli. Bacteria Shigella and parasite Cryptosporidium are also major agents globally ..17].The included studies were categorized according to the type of intervention studied, which resulted in a group of eight common bottom-up, non-pharmaceutical, primary preventive interventions, based on the health-EDRM framework. These were: two “personal” protective practices , four “household” practices  and two “community” practices  were identified. 13% of the studied literature was associated with personal practices, 65% with household practices and 22% with community practices. The review of evidence was disaggregated according to the eight preventive interventions, and categorized according to OCEBM Levels of Evidence , which cThe comparison of the strength of evidence of the reviewed literature  showed tThe majority of the reviewed studies demonstrated positive relationship between primary preventive interventions on diarrhea incidence and disease transmission by addressing WBD associated health risks, however, there is a lack of assessed literature that quantifies the extent of the efficacy of such interventions on disease reduction. In the case of water treatment, many studies conferred a well-established link between less contaminated household drinking water and reduction in diarrhea risk, but not the effectiveness of WBD reduction and associated health outcomes, such as mortality, within the community ,100,101.This narrative review examined evidence of eight primary preventive interventions against WBDs. The interventions share certain enabling and limiting factors that affect the success of proposed preventative interventions when applied to the health-EDRM framework: resources accessibility and affordability, accommodating community health facilities, correct understanding of WBD associated health risks, sustainable behavioral change, cultural relevance, and cross-sector collaboration with top-down contribution from policy makers. By contrast, socioeconomic barriers, geographical location and cultural incompetence were noted as key limiting factors.Many of the primary preventive interventions examined in this review were complex interventions that relied upon a combination of enabling factors to reduce WBD. For instance, a large proportion of interventions required access to material resources, ranging from simple soap to materials for constructing facilities. However, in very low-resource settings, contributions from authorities and policy-makers are also essential in order to provide these material resources. For instance, in order to ensure sustainable delivery of safe water supply and waste management systems in low income areas, multi-sectoral collaboration and coordination from local and national-level authorities is necessary. Furthermore, in order to successfully implement behavioral interventions such as the appropriate use of prophylactic supplements, government support and capacity within health system is often required. Policy makers should, therefore, re-prioritize the delivery of sustainable water and sanitation services as the importance of safe water access to reduction in WBD incidence has been reinforced in this review.This review noted that primary interventions for reducing WBDs also often require addressing pervasive misconceptions, attitudes and social norms. For instance, WASH- education campaigns were successful in teaching participants to associate contaminated water and poor hygiene with diarrhea-related illnesses ,99,105. Many It is important to note that the effect and impacts of preventive interventions are cross-cutting. The uptake of one intervention should not impede the practice of another, and despite the mixed evidence regarding the cost-effectiveness of multi-intervention programs compared to single intervention ,104,105,This review has identified six major research gaps in the literature relating to health-EDRM primary preventative interventions for WBDs.First, current studies focus on reducing exposure to hazards, such as contaminated water. A total of 73% of the studies in this review proposed interventions, such as improved water treatment, water storage and waste disposal in household and community settings. There is little evaluation on the efficacy of managing other causal factors of in WBD. Future studies can examine interventions that target hazard preparedness and risk-reduction within exposed populations.Second, research outcomes are skewed towards reduction in diarrhea incidence, with lack of evidence on the reduction of other WBD-associated symptoms, such as vomiting and stomach cramps ,35,38. DThird, there is limited research on alternatives of preventive interventions for implementation in resource-poor or material-scarce settings. For example, the beneficial effect of handwashing with soap is consistent across various studies, but there is little evidence to support the use of alternatives, such as ash in communities where soap is not available ,116. TheFourth, there is inconsistency in the recommendations by research institutions for certain preventive interventions between research institutions. For handwashing interventions, the time required for washing to ensure proper hand hygiene was not specified in most studies ,104,105.Fifth, there is little evidence on the efficacy of chemoprophylaxis against WBD. Only one study included prophylactic supplements in their intervention, where a diarrhea pack with water purification sachet was distributed within the community . ComparaSixth, there was limited evidence in comparative evaluation for variations of primary preventive interventions, such as efficacy of the different water storage containers, or different materials to maintain household cleanliness. Strengthening the available evidence in the above-mentioned areas will allow development of strategies for protecting against WBDs in low-resource settings.This study summarized the most common eight primary prevention interventions identified in WASH-related literature and the strengths and limitations of their implementation to improve Health-EDRM outcomes in low-resource communities. There is value in subsequent studies assessing the risks of WASH at multiple levels as pertaining to these interventions through a number of alternative frameworks, including the WASH cluster strategic operations framework and other ecological models.There are some limitations to this review. The review excluded non-English-based literature, non-electronically accessible civilian-published literature, grey literature or any publications before 2000. The review also excluded annual reports from specialized organizations, United Nations reports, or reports by national governments. The eight preventative interventions identified in this review do not constitute all of the non-pharmaceutical preventative behavior that is available in the mitigation of WBD. Moreover, this review has not disaggregated findings by pathogen, for example difference in efficacy of interventions between viral, bacterial, and parasitic diseases. This area warrants further research, in order to review predictive success of interventions across different areas with particular disease patterns.Despite the limitations, this review was able to identify valuable behavioral interventions for the planning and implementation of health policies that prevent water-borne biological hazards. Preparedness in communities facing specific vulnerabilities could be reinforced through multi-faceted and multi-sectoral collaboration, with an emphasis on four key areas  as suggested by the primary prevention model for disaster risk reduction in the Sendai Framework for Disaster Risk Reduction .WBD-associated health risks will remain an ongoing biological hazard to the rapidly globalized world, which highlights the importance of sustainable strategies. In order to meet the SDGs by 2030 , multi-s


Emergency medical services (EMS) use a combination of policy, clinical practice guidelines and protocols to set out their expectations for service delivery and to inform patient care. While these are integral to how EMS now operate, relatively little is known about how they are developed, or the processes involved. Therefore, the aim of this scoping review is to understand what is known in the literature about the development of policy, guidelines and protocols within EMS.X9 reference management software and duplicates will be removed. Titles and abstracts of the results will be independently screened for their relevance to the research question, and the full text of each selected publication will be assessed against pre-determined inclusion and exclusion criteria to determine its eligibility. The reference list and forward citations will be searched for articles meeting the eligibility criteria. A second researcher will independently assess a 10% sample of results to allow for validation of this assessment. Data will be extracted and charted on the characteristics of the publications and the knowledge they contribute on the development of policy, guidelines or protocols. Accompanying narratives will be presented to identify themes and gaps in the available evidence. A critical appraisal will be undertaken of the included publications, where empirical research is presented.This scoping review will follow the  Emergency medical services (EMS) are known to use a combination of policy, clinical practice guidelines (CPGs) and protocols to support front-line EMS clinicians with their clinical decision-making and patient care . In recePolicy, CPG and protocols are used differently within EMS depending on: (a) how an EMS system is structured and organised, (b) the type of care being directed and (c) the size and location of the EMS organisation . IndividTwo recent systematic reviews of evidence-based guidelines (EBGs) in pre-hospital care found that they frequently vary in quality and have noticeable gaps in their methodology and adherence to reporting standards . Even leFor the purposes of this review, the following definitions will be used.EMS will be defined in this review as ‘the system that organises all aspects of care provided to patients in the prehospital or out-of-hospital environment’ . EMS mayPolicy is defined as ‘a set of ideas or plans used as a basis for making decisions’ . PoliciePolicymaking in healthcare is often described as a complex process . CairneyGuidelines are defined as ‘information intended to advise people on how something should be done or what something should be’ . The terThe term protocol describes ‘the exact method for giving medical treatment’ . TreatmeThe term development is defined as the ‘process of coming into existence or of creating something new or more advanced’ . While tA scoping review is proposed in order to identify the range, nature and extent of the literature available on this topic .This scoping review will follow the What is known from the existing literature about the development of policy, clinical practice guidelines and protocols within emergency medical services?The aim of this scoping review is to identify and map the existing evidence on the development of policy, CPG and protocols within EMS. It expects to provide a synthesis of the range, extent and quality of evidence available on this subject and describe any gaps in the existing evidence.The main objectives of this review are:To identify and map the existing evidence on the development of policy, guidelines or protocols in EMS using a structured and systematic scoping review.To describe the nature, range and quality of evidence available.To identify and outline any knowledge gaps in the available literature on this topic.This scoping review will involve a broad search for literature relating to the research question and its objectives. It will search key electronic bibliographical databases Medline, CINAHL, Academic Search Complete and PsycINFO via EBSCO, EMBASE via Ovid, Nursing and Allied Health via ProQuest, the Cochrane library and NICE Evidence. It will search for relevant literature using Scopus, OpenGrey repository, British Library E-Theses Online Service (EThOS) and key EMS journals and websites following discussion with experts within the review team. In addition, Google Scholar will be searched to the first 300 search results  and the British Paramedic Journal, Journal of Paramedic Practice and International Paramedic Practice, Irish Journal of Paramedicine, Prehospital Emergency Care, Australasian Journal of Paramedicine, Canadian Paramedicine, Paramedic PhD website, Guidelines International Network website and Prehospital Guidelines Consortium website.Key EMS journals and websites will be searched to find any relevant articles that may not be discovered from searching electronic databases due to issues with indexing, databases being incomplete or regional bias . After dElectronic databases will be systematically searched using relevant key words, indexed terms and proximity and Boolean operators. The review team has utilised the Library and Knowledge Service for NHS Ambulance Services in England (LKS ASE) guidance documents for how to conduct an effective literature search for EMS literature  in the pX9 reference management software  to come to a decision as to whether to include or exclude the results from the review. The reference list and forward citations of eligible articles will be searched to locate any additional material not discoverable in the initial search .This scoping review will include articles and results that meet the following inclusion criteria:Population and context: This scoping review will include sources that focus on the people who are involved in the development of policy, CPG or protocols within EMS or pre-hospital care. Therefore, it will include sources of information relating to paramedics, emergency medical technicians, policymakers, actors or stakeholders who take part in this process.Concept: This review will include sources that include the development, formulation or production of policy, guidelines and protocols. Therefore, it will consider sources that discuss the development process as part of a larger discussion of implementation, however this will not include sources that consider the implementation without the development process. It will include sources that focus upon the development of organisational, regional and national documents owing to the variation in the size and scope of EMS across the world.Types of evidence: This scoping review will consider a broad range of different sources owing to the relative paucity of empirical research on this topic. It will include primary and secondary research of any methodological tradition, commentary pieces, expert opinions, published conference abstracts, editorials, letters or published narratives as this may be the best available literature on this topic.Language: Articles that are not published in English will be translated using the Google translate function  general information about the results citation and (b) key data relating to the research question and its objectives. Key data will be extracted using a data extraction form adapted from the Joanna Briggs Institute  guidanceevidence source, details and characteristics;citation details, including: author names, date, title, journal, volume, issue and pages);country of origin;context/setting;method of study;results extracted from source of evidence;population involved: who was involved and what was their role?;concept: type of document: policy, protocol or guidelines;concept: how was the development process described? What key actions were involved? What influenced this process?;context: area of practice;describe the summary of findings/results;assessment of quality: using the relevant critical appraisal tool; andlimitations.Charting will be used to sort primary search results according to their key issues and themes .Data will be charted in tabular form with accompanying narrative descriptions. A table of results will provide an overview of how policy, guidelines and protocol are developed within EMS and the quality of evidence found, and describe any gaps in existing evidence. Although this scoping review will not undertake a structured narrative synthesis, prominent narratives will be iteratively grouped into discoverable themes to allow for discussion.The This review will present an overview of all of the evidence found to inform policymakers, researchers and readers about the range of evidence available on that particular topic. Findings from this scoping review will be submitted for publication. Results will be shared through presentations at scientific and professional meetings, and through social media platforms. As all the researchers hold positions within academia within the United Kingdom, there is also an opportunity for this information to be communicated to undergraduate and postgraduate paramedic students during their academic studies. Finally, as this scoping review forms part of a PhD programme, it will form the scientific basis for further original research into policy, guidelines and protocols within EMS.The research team would like to thank Darren Flynn from Coventry University, and Matt Holland from the LKS ASE, for their support in developing a search strategy.JR, MH, TQ: conceptualisation and design; JR: original draft; MH, TQ: writing and editing. JR acts as the guarantor for this article.None declared.None.


Key aspects of the medical management of Kawasaki disease (KD) are not yet supported by a high evidence level, thus making room for individual recommendations. We performed a structured comparison of existing international KD guidelines to analyze potential differences in the implementation of evidence-based KD recommendations regarding diagnosis and therapy. To identify country-specific guidelines, we took a multilateral approach including a comprehensive PubMed literature, online research, and directly contacting national pediatric associations. We then ran a structured guidelines’ analysis and evaluated the diagnostic and therapeutic differences in the context of evidence-based medicine. In this structured guideline analysis, we identified nine national and one European guidelines. According to them all, the diagnosis of KD still relies on its clinical presentation with no reliable biomarker recommended. First-line treatment consistently involves only intravenous immunoglobulin (IVIG) therapy. Recommendations in terms of acetylsalicylic acid, corticosteroids, and additional therapeutic options vary considerably.Conclusion: According to all guidelines, KD is diagnosed clinically with some variance in defining incomplete KD and being a non-responder to treatment. First-line treatment consistently includes IVIG. Recommendations for additional therapeutic strategies are more heterogeneous. Kawasaki disease (KD) is diagnosed worldwide based on the classical clinical symptoms first described by Dr. Tomisaku Kawasaki . If someEarly treatment options included corticosteroids; however, since they were associated with raising the risk of CAA , they haNational disease-specific guidelines should rely on the latest evidence available at the year of publication and in the local setting of the population. The KD evidence however varies not just in the ethnic background. As many aspects are not supported by strong evidence, there is room for individual interpretations. This is currently of special interest, given that young people suffering post-COVID-19 multisystem inflammatory syndrome in children (MIS-C) can present with Kawasaki-like disease, and its treatment is derived from KD treatment options so far . We therWe took a step-wise approach to identify national guidelines: first, a systematic PubMed and Medline research, including the keywords “Kawasaki disease, Mucocutaneous lymph node syndrome (MCLS), guidelines, scientific statement”; then, a structured search on the official website of national and international pediatric societies including the subspecializations pediatric cardiology, pediatric rheumatology, and pediatric infectious diseases was performed. If those were unsuccessful, we consulted the current directors of each national society concerning the existence of a national KD guideline and, if in case of none, which other country’s guidelines they officially rely on. If we were unable to identify or contact a country-specific society, we directly contacted pediatricians worldwide via a standardized questionnaire  , DenmarkAccording to all guidelines, KD diagnosis still relies on the clinical presentation. Five or more days of fever plus at least 4/5 clinical criteria need to be present for a diagnosis of complete KD. The Japanese guideline  included.Most countries define incomplete KD as ≥ 5 days of unexplained fever fulfilling fewer than 4 clinical criteria. However, the minimal number of symptoms required for diagnosis is not specified in all guidelines. Some include the patients’ age in their definition, as younger children are likely to present with fewer symptoms. JP includes the presence of CAA or dilatation in their definition of incomplete KDIn addition to incomplete KD, AR and IT refer to atypical KD in case of “uncommon” symptoms, i.e., meningeal inflammation, seizures, facial paralysis, acute abdomen, pancreatitis, nephritis, cardiogenic shock, cholestatic jaundice, arthritis, and pneumonia.None of the guidelines available recommended a specific KD biomarker. The American Heart Association (AHA) developed an algorithm based on expert consensus, for patients with suspected incomplete KD. This algorithm, which combines laboratory findings and imaging for the targeted clinical assessment, is designed to accelerate determining the treatment indication for patients with suspected incomplete KD, but not to differentiate from other febrile diseases. ES, DE, and DK integrated this algorithm in their guidelines . In thisThe definition of IVIG resistance varies slightly among different guidelines, with all guidelines considering fever as the main clinical target. Fever should be persistent or recrudescent for at least 24 h according to ZA and 48 h according to SHARE. Fever should resolve within 36 h after having completed IVIG therapy according to the remaining guidelines. Furthermore, laboratory signs of inflammation  and clinical signs should resolve significantly  to attest to the clear effectiveness of first treatment.1-antihistamine, 1 h prior to IVIG administration.All guidelines recommend first-line treatment with IVIG at a dosage of 2 g/kgbw in combination with ASA. IVIG is generally administered over an 8–12-h period. The Japanese guidelines provide detailed information about administration time, depending on the specific IVIG product, emphasizing that according to the Japanese latest nationwide survey it is generally administered 12–24 h [Dosage of ASA in first-line treatment varies between low (3–5 mg/kgbw/d), moderate (30–50 mg/kgbw/d), and high (80–100 mg/kgbw/d) doses. The US recommends both moderate and high-dose ASA, but no clear preference for either. AR and DK suggest high dose; DE, IT, ES and SHARE recommend a moderate dose. According to all guidelines, ASA should be reduced to low dose (3–5 mg/kg body weight/d) 48 to 72 h after the fever resolved. SE is the only country that proposes starting therapy with low-dose ASA (2–5 mg/kgbw/d), considering a combination with other NSARs or paracetamol. JP explicitly recommends medium-dose ASA in patients presenting with fever and starting with low-dose ASA in patients already presenting afebrile.Applying corticosteroids in addition to initial IVIG treatment remains controversial. Guidelines with older publishing dates like AR, DK, and ZA do not suggest corticosteroids, and none of the other guidelines recommends general administration in all patients. Most countries recommend first-line corticosteroid therapy only in patients carrying a predictably high risk of being non-responsive to first IVIG treatment , and anakinra, an interleukin 1 receptor antagonist. There seem to be no clear arguments supporting any one biological across all guidelines  and anti-platelet (low-dose) effects. There is unfortunately no evidence-based ASA effect on either the development of coronary aneurysms , 28 or IThe use of corticosteroids in KD experiences a renaissance. Unlike guidelines with older publishing dates such as AR (2016), DK (2015), and ZA (2013), the more recent ones support administering first-line corticosteroids in “high-risk” cases. Corticosteroids are proposed in two forms: IVMP is given at a dosage up to 30 mg/kgbw/d either as a single pulse or for 3 consecutive days. PSL is usually recommended at a dosage of 2 mg/kgbw/d for a longer time-course and is gradually tapered after normalized CRP and symptoms. Some guidelines recommend starting with IVMP and continuing thereafter with PSL, as illustrated above.The PSL regime relies on the “RAISE Study” , the firCorticosteroids as second-line treatment in case of IVIG-resistance have unfortunately not been proven either to have a significant effect on lowering the CAA rate , 35. NevFurther therapeutic options for children with IVIG-resistant KD are biologicals that focus on blocking the interleukin 1 , 37 or TTwo multi-centric trials are investigating anakinra–the ANAKID  anakinr.CsA inhibiting the Ca2 + /NFAT pathway might contribute to KD susceptibility and CAA development . AccordiThe world is currently experiencing a pandemic caused by severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV-2). Although this infection in children is rarely associated with severe disease, in some cases it may lead to a serious inflammatory condition, clinically overlapping with KD, termed pediatric inflammatory multisystem syndrome (PIMS) or multisystem inflammatory syndrome in children (MIS-C). On account of this illness presenting only since recently, the recommendations already provided reflect the currently available evidence of low quality, based on a limited number of case series, retrospective cohort studies, and expert opinions, mostly on basis of KD therapeutic strategies , 43. TheThe clear evidence regarding the first-line IVIG treatment in Kawasaki disease is reflected by consistent treatment recommendations. The less conclusive reliable evidence on additional therapeutic options results in more heterogeneous therapeutic recommendations, which vary also according to the ethnic background and year of publication. High-quality studies are necessary to hopefully increase evidence with time, giving a more solid platform for future recommendation.