The use of intravenous fluid therapy in patients with major trauma in prehospital settings is still controversial. We conducted an umbrella review to evaluate which is the best volume expansion in the resuscitation of a hemorrhagic shock to support the development of major trauma guideline recommendations.We searched PubMed, Embase, and CENTRAL up to September 2022 for systematic reviews (SRs) investigating the use of volume expansion fluid on mortality and/or survival. Quality assessment was performed using AMSTAR 2 and the Certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.We included 14 SRs investigating the effects on mortality with the comparisons: use of crystalloids, blood components, and whole blood. Most SRs were judged as critically low with slight overlapping of primary studies and high consistency of results. For crystalloids, inconsistent evidence of effectiveness in 28- to 30-day survival (primary endpoint) was found for the hypertonic saline/dextran group compared with isotonic fluid solutions with moderate certainty of evidence. Pre-hospital blood component infusion seems to reduce mortality, however, as the certainty of evidence ranges from very low to moderate, we are unable to provide evidence to support or reject its use. The blood component ratio was in favor of higher ratios among all comparisons considered with moderate to very low certainty of evidence. Results about the effects of whole blood are very uncertain due to limited and heterogeneous interventions in studies included in SRs.Hypertonic crystalloid use did not result in superior 28- to 30-day survival. Increasing evidence supports the scientific rationale for early use of high-ratio blood components, but their use requires careful consideration. Preliminary evidence is very uncertain about the effects of whole blood and further high-quality studies are required.The online version contains supplementary material available at 10.1186/s12245-023-00563-4. Traumatic injury is one of the leading causes of death worldwide, representing approximately 10% of global deaths, especially in the young population , 3 and rJudicious fluid resuscitation is the first step in the hemodynamic management of patients with hemorrhagic shock to avoid an increase in bleeding and protect the patient from severe consequences of hypovolemic shock . A multiVolume replacement is still cornerstones to correct fluid deficits during early trauma resuscitation, but the conduct and reporting of literature are various in terms of purpose and outcome measurements. The aim of this umbrella review is to map the scientific literature on the type of resuscitation fluids and establish an overall view of the available evidence on their use in trauma patients with hemorrhagic shock.https://osf.io/86k5u/. The report has been written according to the Preferred Reporting Items for Overviews of Reviews (PRIOR) [We applied the Cochrane method for overviews of reviews and the JBI guidelines for umbrella reviews to systematically map the use of expansion fluids in the resuscitation of trauma patients with acute hemorrhage to reduce mortality , 17. The (PRIOR) .What is the best volume expansion fluid to use in the resuscitation of hemorrhagic shock? We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE)-ADOLOPMENT approach for guideline production [We conducted an overview of reviews to support the major trauma integrated management guideline panel of our Institute of Health , 20 in foduction , adoptedoduction , to guidoduction .Population: adults who have experienced a traumatic incident. Pre-hospital and emergency department (ED) have been considered because initial management in ED is a prolongation of the pre-hospital treatment (continuum of care concept); (2) Interventions: crystalloids, packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets (PLT), liquid plasma, lyophilized plasma, low titer 0-negative whole blood (LT0WB); (3) Comparisons: a comparison or combination of the above (including different ratios). We defined blood component therapy as “plasma and/or PRBCs ” whereas we defined standard care as “infusion with crystalloids, no transfusion, unknown or combination with blood components” [Outcome: overall mortality and/or survival . We excluded people with a major trauma resulting from burns, and patients in hypovolemic shock not caused by trauma.We included studies if they were systematic reviews of original research , with or without meta-analyses that investigated the effectiveness of different kinds of fluid replacement in patients with hemorrhagic shock after a traumatic incident. We defined a systematic review, based on Cochrane’s definition, as a review of the literature in which one “attempts to identify, appraise and synthesize all the empirical evidence that meets pre-specified eligibility criteria to answer a specific research question by using explicit, systematic methods that are selected with a view aimed at minimizing bias, to produce more reliable findings to inform decision making” . We exclponents” ; (4) OutWe used the search strategy performed by the adopted NICE guideline  from 26,The search strategy is outlined in Additional file Two independent authors  screened titles and abstracts obtained with the selected search strategy. Each reviewer then independently assessed the full text of potentially relevant studies for inclusion. Any disagreement was solved by a discussion with a third reviewer (OC). We adopted a standardized data collection form to extract the following information: review characteristics , patient characteristics , and interventions examined . A list of the primary studies included in all the systematic reviews with meta-analysis was compiled and cross-referenced with the primary studies included in the SRs. We contacted authors if the reported data were insufficient or unclear.Quality appraisal was completed concurrently with data extraction using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2) Checklist tool , an updaWe adhered to all data collection and synthesis methodology outlined in the Cochrane Handbook’s chapter on overviews of reviews and JBI Manual for Evidence Synthesis , 29. No We summarized the main results of the included reviews by categorizing their findings in the following comparisons (1) use of crystalloids, (2) use of blood components (a) and their blood components ratios (b), (3) use of whole blood (WB). Lists of the primary studies in each included review were collated and cross-referenced in the matrix of evidence tables to ascertain the degree of overlap between reviews for each treatment comparison of mortality outcome and to provide context for the results. Additionally, a matrix of evidence for the entire overview was prepared and used to calculate the “corrected covered area” (CCA) to quantify the degree of overlap between all the reviews included in this work .A total of 3689 records were screened, 3655 were excluded after the title and abstract screening while 20 were excluded after a full-text reading  published in 2020. Literature search dates for the included reviews ranged from 2015 to 2022 (min–max). A total of 210 studies were included in the SRs with 46 randomized controlled trials and 164 observational studies. Most SRs (79%) performed a meta-analysis. Characteristics of included studies are reported in Table In Table n = 1440, OR = 1.13; 95% CI 0.75–1.70; I2 = 43%; p = 0.56). Nevertheless, the results were statistically significant for the secondary endpoints, 24 h survival , and overall mortality  respectively. Additional file We found one systematic review of RCTs investigating hypertonic saline/dextran or hypertonic saline versus isotonic fluid . This syp < 0.0001; 3 observational studies: OR = 0.49; 95% CI, 0.29–0.83, p = 0.008), while no superiority was found between PRBCs alone when compared to standard care . Pre-hospital plasma infusion seems to reduce 24-h mortality in haemorrhagic shock patients .We found two SRs addressing this comparison in the pre-hospital setting. Specifically, one systematic review included observational studies and RCTs investigating the effect of both PRBCs alone and plus plasma versus standard care  and the We found different ratios of blood components use: (I) FFP: PLT: PRBC, (II) FFP: PRBC, (III) PLT: PRBC in which we found 3 systematic reviews , 32, 35,Six systematic reviews investigated the comparison of WB components vs component therapy  , 39–43. The quality appraisal of included SRs ranged from critically low quality to moderate quality and overall items are reported in Fig. Consistency of evidence was found in all comparisons. The certainty of the evidence was heterogeneous across comparisons and outcomes and ranged from very low to high according to comparisons and outcomes. Table This umbrella review explores the evidence which has been published about initial resuscitation from hemorrhagic shock in trauma patients. The setting of intervention considered was the pre-hospital and emergency department care.With respect to the crystalloids comparison, the use of hypertonic saline/dextran compared to isotonic fluid solutions did not result in a superiority at the primary endpoint 28- to 30-day survival (moderate to high CoE), while an improvement of the survival at 24 h, and less overall mortality (secondary endpoints) in patients with hypotension were found. The results of 28- to 30-day survival have been confirmed by a recent systematic review with meta-analysis in patients with severe traumatic brain injury that has shown no better survival for patients treated with hypertonic saline when compared to normotonic crystalloids  . FurtherWithin the blood components comparison, the PRBCs compared to standard of care have shown little to no effect on mortality at 24 h as well as at 30 days with very uncertain (very low CoE) level of evidence. Adding plasma to PRBCs has shown to be effective in reducing 30-day mortality (low to moderate CoE), and using plasma alone seems to reduce the 24-h mortality compared to standard care (moderate CoE). These results are consistent with a secondary analysis from a non-randomized study which reported that the use of fresh frozen plasma in combination with packed red cells was beneficial, compared to usual care . ConversOur overview identifies seven SRs comparing different ratios of blood components used . With complete concordance among all SRs, we found significant results in favor of higher ratios among all comparisons considered  even though patients randomized to prehospital LTOWB had lower red cell transfusion requirements at 24 h (p < 0.01), lower incidence of Multiple Organ Failure and no transfusion reactions [43, improved survival, and decreased overall blood utilization [Regarding WB use compared to component therapy, all SRs agreed to no difference between interventions in terms of reduced mortality for patients with major trauma. The use of this intervention can be contextualized on studies conducted in the ED setting considering that our SRs included different types of WB , fresh WB, unrefrigerated young WB, and unspecified WB). Recent developments show promising effects during the prehospital or in-hospital setting. A recent pilot RCT, showed no statistical mortality benefit at 28 days when compared to standard care  compared to room temperature stored platelets (5 days), and WB increases the storage duration of platelets 3 to 7 times more than a platelet concentrate . The useHowever, some limitations should be underlined. The reporting and conduct of our sample were heterogeneous in terms of purpose and outcome measurement. In fact, we included SRs that addressed different clinical intervention questions (CCA indicating little to no overlap across reviews), and around two-thirds were of critically low quality. As a note of this clinical heterogeneity, we included SRs focussed on different trauma scenarios. For example, some evidence comes from pre-hospital  or ED setting  as a continuum of care. The clinical heterogeneity also regards the multiple confounding factors. For example, in the blood components comparison, the two SRs differently classify the intervention of the PAMPER trial  ).To support the major trauma-integrated management guideline of our Institute of Health the panel provided the following recommendation. Using blood components in the earliest phase  is suggested in patients with hemorrhagic shock and coagulopathy. (weak recommendation based on low certainty of evidence) (Indeed, based on the most recent literature and the physiopathology rationale , the impFuture efforts should be devoted to improving the organization, skills, and competence of the personnel dedicated to blood transfusion. Pre-hospital care should enhance the adoption of standards and quality indicators at the international level . This inBased on the results of this overview, clinicians should consider volume expansion in resuscitation as a first-line intervention. Hypertonic crystalloid use did not result in a reduction of 28- to 30-day survival, supported by moderate certainty of evidence. Increasing evidence supports the scientific rationale for the early use of blood components with a high ratio to reduce mortality even though their use requires careful considerations, and no firm conclusion can be drawn. Preliminary evidence is very uncertain about the effects of WB due to limited and heterogeneous interventions in studies included in SRs. Further efforts should be made in conducting high-quality RCTs needed to draw more accurate conclusions on blood components or WB transfusion.Additional file 1: Appendix 1: Supplement 1. Search strategy and PICO question. Table S1. Detailed general characteristics of included systematic reviews. Table S2. Map of primary studies contained within each included systematic review per different comparison. Table S3. Mortality/survival, comparison hypertonic crystalloids vs isotonic crystalloids. Table S4. Mortality, use of blood components. Table S5. Mortality, blood components ratios. Table S6. Mortality, whole blood components. Supplement 2. Characteristics of excluded SRs. Supplement 3. Summary of findings.


In this research we examine the Community of Inquiry model and further develop the model by integrating a complementary institutional presence. For this purpose, a questionnaire including five presences and 73 questions was designed. In total, a response of 762 questionnaires from five universities were collected. Correspondingly, statistical analysis like factor analysis and structural equation model were conducted. The present paper is, duly, a quantitative investigation of the correlations between institutional presence and other presences in the new model as well. Finally, a further developed Community of Inquiry model that integrates institutional presence is generated. With a relatively large sample, the results meet the applicable requirements, indicating that the generated model is acceptable and fits well with the data. Despite the extensive research on online and blended learning conducted over the last decade, the development of theoretical models specific to these environments remains inadequate. Be that as it may, one of the most intriguing models that is worth pointing at as appealing enough is the Community of Inquiry (CoI) model developed by By virtue of the core rationale of the present paper, which lies in an accomplishment of a markedly systematic and constructively developed CoI model incorporating the entirety of the features that renders it a Further Developed Community of Inquiry (FDCoI) model, a further relevantly underpinning theoretical framework has been intently formulated in the literature review section, whilst the utterly directing research questions, hypotheses, participants as well as instruments are being illustrated in the methodology section. By the same token, descriptive statistics, a normal test, exploratory factor analysis, confirmative factor analysis and a structural equation model were intricately performed and comprehensively elucidated in the findings section. As a grounded theory, then, the further developed CoI model is subsequently generated in the discussion section, without a minimum indifference and disregard as far as this paper broad limitations, which the conclusion highlights, are concerned.The primary objective of this research is to examine the CoI model  and the (1) Can institutional presence be integrated in the CoI model?The classical CoI model has three presences (dimensions): teaching presence, social presence, and cognitive presence. (2) If so, how should institutional presence be integrated in the CoI model?If the newly proposed five-presence model is deemed appropriate, an additional line of inquiry that warrants attention is how to incorporate institutional presence into the CoI model in a manner that accurately reflects its structural relationship with other CoI presences. Specifically, the investigation seeks to ascertain whether institutional presence exhibits moderate to strong standardized loadings and significant interactions with the other four presences by analyzing the results obtained from the structural equation model.The hypothesis of this study is that the CoI model could be further developed by the addition of an institutional presence. This development is based on a model for institution employment of online and blended learning in universities . On the 2.2.1.Despite the plethora of available online and blended learning models, research on the quality of online and blended learning has placed considerable emphasis on the CoI model, first introduced by In its notable peculiarities, cognitive presence is associated with the student’s construction and confirmation of meaning, pertaining to course content, on the basis of sustained reflection and discourse within the CoI. Consequently, it has been a subject of research to a large extent by various scholars , most ofIn terms of social presence, it refers to the learners’ capacity to present themselves as genuine individuals, both socially and emotionally, within the CoI. This area has been the subject of extensive research , with reWhat ought to be inferred, accordingly, is that Teaching presence focuses on the organization, design and facilitation of the cognitive and social components of a course with the aim of achieving the sought-after educational outcomes. Additionally, a further noteworthy finding of research on social presence in the CoI model, which has expanded the realm of its exploration , pertainDespite the extensive body of studies have supported the CoI as a model of online and blended learning, further development of best practices that promote an educational community is warranted. For instance, 2.2.Acknowledging that the principal argument of this paper is the potential of a further development of the CoI model, it is crucial to highlight the endeavors of Nonetheless, previous research on learner presence has been limited, except for a notable study by From another perspective, the necessity of incorporating ‘learner presence’ in the questionnaire entailed, as 2.3.This paper utilizes the model for institutional employment of online and blended learning in universities developed by Although institutional presence is not directly associated with the learning process, it is inseparable from the process and can, therefore, be considered a component of the CoI model. In view of 2.4.In light of previous research and the associated findings, there is high likelihood that institutional presence dwells in a close connection with teaching and learner presences. Hence, of paramount value to this study is the obvious support which teaching and learner presences benefit from institutional presence in several dimensions. Institutional presence offers support to teaching presence and learner presence in several ways. First and foremost, institutions provide instructional guidance and learning environments that cater to the teaching and learning process. Moreover, instruction criterias of institutions are employed for learning, offering students and teachers with flexible choices for their learning process . Second,In turn, teaching presence and learner presence possess the potential to positively impact institutional presence and, whilst the institution equally benefits by means of further proactively managing the student relationships and reassuring that learning requirements are met in a timely manner . As is sConsequently, enhancing interaction and reciprocity among institutional presence and learning and teaching presences, it is quite recommendable that learners are aware of services they can expect to receive from the institution and the manner they will be provided . On thatPrevious studies suggest that institutional presence may closely relate to social and cognitive presence. Social presence is expected to be affected, at least to some extent, by institutional presence, given that institutions invariably govern people’s behaviour and attitudes, and everyone seeks to accommodate each other’s requests, responsibilities, and roles . TherefoConcerning cognitive presence, it is highly probable that links between institutional presence and cognitive presence evenly exist in accordance with 2.5.Based on the preceding literature review, the CoI model has been extensively researched and has matured since its inception as a framework for the three classical presences. However, a research gap remains in the model’s ability to integrate additional presences, such as learner and institutional presence. Although some studies have examined learner presence and its relationship with the original three presences, the gap persists when institutional factors are considered. As institutional factors are inextricably linked to the learning process, adding institutional presence to the CoI model is a promising approach to fill this gap. This paper aims to explore the extent to which institutional presence can be incorporated into the CoI model, given its comprehensive and extensive insights.This paper’s significance lies in three areas: (1) the CoI model’s historical status and significant role in online and blended learning fields underscores the importance of its development; (2) the addition of institutional presence to the model is a substantial and transformative development, as it alters the model’s structure significantly; and (3) the integration of institutional presence is both necessary and beneficial due to its inseparability from the learning process and its close relationship with the other presences.3.3.1.Data was collected by teachers in five Chinese universities in 2021. Because the goal of the research is to test and discern the relationships among five presences, the primary target was students involved in all the presences. To achieve this, the teachers asked their students to complete the designed questionnaire voluntarily. In total, 762 student participants answered the questionnaire. These participants were all universities students  from five Chinese universities . The participants came from eleven faculties . Both male and female students were included. Demographic information could be found in 3.2.Drawing on the aforementioned theoretical frameworks, a survey instrument comprising five dimensions - Social Presence, Cognitive Presence, Teaching Presence, Learner Presence, and Institutional Presence - was designed. The CoI instrument  was utilα = 0.91), cognitive (α = 0.95), and teaching presence (α = 0.94)  . Out of 4.In this section, the results of descriptive statistics, a normal test, explorative and confirmative factor analysis, and a structural equation model are introduced and explained successively.p < 0.05), informing that the data is not normally distributed.The descriptive statistics and Kolmogorov–Smirnov test were conducted with the research variables and questions in the questionnaire. The results, seen in Explorative factor analysis was conducted for five presences separately to reveal the underlying structure of the study’s relatively substantial variables. The results of the explorative factor analysis are displayed in p < 0.001). The cognitive presence dimension yielded two factors with eigenvalues greater than 1, explaining 63.19% of the variance. The institutional presence dimension delivered a single factor with an eigenvalue greater than 1, explaining 67.852% of the variance. The learner presence dimension yielded five factors with eigenvalues greater than 1, explaining 58.256% of the variance. The social presence dimension also yielded two factors with eigenvalues greater than 1, explaining 65.903% of the variance. Finally, the teaching presence dimension yielded two factors with eigenvalues greater than 1, explaining 70.275% of the variance. The rotated factor matrix shows that each question has a high loading for only one factor, and the factor loading values exceed 0.5, indicating that the factor structures are sound. The validity of the scales is acceptable.Confirmative factor analysis was then operated to test structural validity further. Eventually, as Because the data is not normally distributed, the Bootstrap method (2000 times) was used to perform parameter estimation. The model fit index after model correction was obtained. As noticeable in χ2 = 243.165, df = 80, χ2/df = 3.040, TLI = 0.984, CFI = 0.987, RMSEA = 0.052). Besides, according to the research of χ2 (513) = 900.5, p < 0.001; CMIN/DF = 2.25; GFI = 0.83, IFI = 0.92, TLI = 0.91, CFI = 0.92; RMSEA = 0.055)]. Our addition of the institutional presence proves a better optimized CoI model because the CFI value shows a higher degree of the fitting.Finally, the SEM was conducted to test the relationship among TP, IP, LP, SP and CP. Because the data are a non-normal distribution, the bootstrap method (2000 times) was used to extract the parameters. Regarding the model construction, the latent variables TP, IP, LP, and SP were treated as independent variables, and the latent variable CP was treated as the dependent variable to explore the effects of the independent variables on the dependent variable and the relationships among the independent variables. By virtue of the excessive questions which the questionnaire incorporated, the balance method for packaging was alternatively implemented to simplify the model. That being the case, the questions in each scale were sorted into three packages according to their factor loadings. Finally, the model was generated as schematized in β = 0.179, p < 0.01). The effect of SP on CP was also significant , but the effect of IP on CP was not significant . The effect of LP on CP was significant . The correlation between TP and LP was significant . The correlation between TP and IP was significant . The correlation between TP and SP was significant . The correlation between SP and IP was significant . The correlation between LP and IP was significant . And the correlation between LP and SP was significant .The main coefficients in the SEM are demonstrated in 5.If the dominant argument as well as core objective of the present quantitative study lies in its addendum of institutional presence to further develop the CoI Model, the achieved findings reflect the suitability of the model as long as it is relevant to the data. By the same token, institution presence has moderate to strong standardized loadings and significant interactions with teaching presence, social presence and learner presence. Therefore, our analysis of the first research question, which seeks to determine whether institutional presence can be integrated into the CoI model, confirms the positive integration of this construct into the CoI framework. Furthermore, the study’s findings align with β = 0.048, p > 0.05). Equally significant, the correlations among IP and other presences  were all significant (p < 0.01). On that premise, Concerning the second research question , what ought to be inferred through path analysis and the realized findings is that teaching presence, social presence, and learner presence all significantly affect cognitive presence. In contrast, the effect of IP on CP was not significant ; Beijing Social Sciences Planning Project of Beijing Municipal Education Commission “Comparative Study on the Effectiveness of Online Learning and Traditional Learning in Municipal Universities” (SM202110005009); The Decision Consultation Project of the Beijing Social Sciences Foundation “Evaluation and Countermeasure Research for the Effectiveness of Engineering Blended Learning in Municipal Universities” (22JCC120).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.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Adopters of innovation have been described by Rogers  as belonAt each step of the communication process, innovation needs to be presented in a manner that stimulates interest , and posMaintaining interest in the incremental acquisition of evidence is not a process to which the human brain is well adapted. Attention to hazards and potential problems is programmed in our DNA and will always exceed our interest in familiar and safe activities . While tUnderstanding these considerations is important when preparing a manuscript for publication. Whether it is to report an innovation, its scientific evaluation or scrutiny of accumulated evidence, the authors should focus on evidence rather than optimism. The authors must accept that their manuscript may be less interesting than a catalogue of clinical mishaps and failure. Few journals will ever publish papers that become known to the general public, and relatively few clinicians will prefer an evening reading their specialist journal over socializing with friends. Nevertheless, journals provide our repositories of shared knowledge and experience. In this regard, their value cannot be overstated and any effort required to acquaint ourselves with their content can only enhance our practice.The development of extra-articular hip preservation surgery has paralleled the development of interventions for intra-articular interventions. Reports of hamstring tendon ruptures are not new , case seThis issue includes two systematic reviews. The paper from Banks  identifiThe paper from Curley  investigJournal of Hip Preservation Surgery.I hope that you enjoy all the papers in Issue 10.2 and that you will be inspired to innovate, evaluate and report your work in the


Lack of evidence-based information regarding potential biological risks can result in inappropriate or excessive biosafety and biosecurity risk-reduction strategies. This can cause unnecessary damage and loss to the physical facilities, physical and psychological well-being of laboratory staff, and community trust. A technical working group from the World Organization for Animal Health , World Health Organization (WHO), and Chatham House collaborated on the Biosafety Research Roadmap (BRM) project. The goal of the BRM is the sustainable implementation of evidence-based biorisk management of laboratory activities, particularly in low-resource settings, and the identification of gaps in the current biosafety and biosecurity knowledge base.A literature search was conducted for the basis of laboratory design and practices for four selected high-priority subgroups of pathogenic agents. Potential gaps in biosafety were focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Categories representing miscellaneous, respiratory, bioterrorism/zoonotic, and viral hemorrhagic fever pathogens were created within each group were selected for review.Information sheets on the pathogens were developed. Critical gaps in the evidence base for safe sustainable biorisk management were identified.The gap analysis identified areas of applied biosafety research required to support the safety, and the sustainability, of global research programs. Improving the data available for biorisk management decisions for research with high-priority pathogens will contribute significantly to the improvement and development of appropriate and necessary biosafety, biocontainment and biosecurity strategies for each agent. Preliminary study and discussion among biosafety professionals suggest that the current evidence base to inform laboratory biological risk management has gaps and that biosafety and biosecurity policies are not always based on clear evidence. Gaps in the evidence base and nonevidence-based approaches may result in the use of unsound or unnecessary biosafety procedures. This can increase costs and create challenges regarding laboratories' sustainability. For example, maintaining highly sophisticated equipment may increase risks with little or no increment in safe and secure operations. Unnecessary measures can overburden, distract, or demotivate the laboratory worker. Furthermore, unsound procedures may give the laboratory worker a false sense of security while providing questionable levels of protection.The World Organization for Animal Health , World Health Organization (WHO), and Chatham House collaborated to improve the sustainable implementation of laboratory biological risk management, particularly in low-resource settings. This study involved assessing the current evidence base required for laboratory biological risk management performance to provide better access to evidence, identify research and capability gaps that need to be addressed, and provide recommendations on how an evidence-based approach can support biosafety and biosecurity in low-resource settings.The Biosafety Research Roadmap (BRM) project aims to support the application of laboratory biological risk management and improve laboratory sustainability by providing an evidence base for biosafety measures (including engineering controls) and evidence-based biosafety options for low-resource settings. This will inform strategic global health security decisions and laboratory system investments.The BRM project involved the formation of a 15-member technical working group (TWG) that was interdisciplinary, inclusive of researchers from public health, clinical science, biomedical science, epidemiology, and veterinary science, as well as experts in the fields of infectious diseases, biosafety and biosecurity, animal health, and disease control and prevention.The objectives of the BRM were to perform a gap analysis for a selected list of priority pathogens on procedures related to diagnostic testing and associated research for those pathogens, including but not limited to sample processing, testing, animal models, tissue processing, necropsy, culture, storage, waste disposal, and decontamination.The TWG was asked to determine the sufficiency and identify gaps (1) in scientific evidence to perform a biological risk assessment for the specified priority pathogens and (2) to support the biosafety practices commonly used while handling the specified priority pathogens. Furthermore, the TWG was to examine commonly used biosafety practices to determine their suitability and sustainable feasibility to implement in a low-resource setting and identify alternative evidence-based measures more suitable for low-resource settings.Shigella spp.; Group B: respiratory pathogens: Mycobacterium tuberculosis and zoonotic avian influenza, and SARS-CoV-2; Group C: bioterrorism/zoonotic pathogens: Bacillus anthracis and Brucella melitensis; Group D: viral hemorrhagic fevers: Crimean Congo hemorrhagic fever and Lassa fever.A final priority pathogen list included—Group A: miscellaneous pathogens: foot and mouth disease and TWG members were assigned to each pathogen group depending on their area of expertise to determine the evidence, knowledge gaps, and analysis of the findings for each pathogen.Initial literature searches were performed for each pathogen in the approved pathogen list. The team screened databases, websites, publications, reviews, articles, and reference libraries for relevant data. Searches were conducted using related search terms to find the evidence and knowledge gaps in the biosafety of the chosen pathogens. The main research domains used to perform the literature searches were the ABSA International (ABSA) database, Belgian Biosafety Server, US centers for disease control and prevention reports, WHO reports, PubMed, and internet searches for terms related to biosafety matters, including, for example, inactivation, decontamination, laboratory-acquired infections (LAIs), laboratory releases, and modes of transmission.Where necessary, working group members were approached for their expertise and other relevant information on specific subject areas. The information collated aimed to include the most recent studies and data to ensure the assessment was up to date. However, earlier studies were cited in cases where recent publications were challenging to find.The findings of the literature searches were compiled into preliminary biosafety sheets comprising pathogen classification, pathogen characteristics, clinical and laboratory hazard identification, risk factor assessment, an overview of the evidence, and potential gaps in biosafety (with direct evidence quotes). The summary of evidence and potential gaps in biosafety was divided into five main sections: route of inoculation/modes of transmission, infectious dose, LAIs, containment releases, and disinfection and decontamination strategies.The authors have identified a series of evidence gaps for the specific pathogens that were studied. The main topic areas where gaps are described include decontamination and inactivation, LAI, engineering controls, transmission route under experimental conditions, organizational measures, risk assessment, infectious dose, personal protective equipment (PPE) use, measures in diagnostic settings, and occupational health and surveillance measures. Based on the outcomes from the WOAH BRM, there is a requirement to perform applied biosafety research to determine the evidence base for biosafety and biorisk practices. The only way for staff to be confident in biosafety practices is to understand the basis on which activities are decided rather than the perpetuation of biosafety “folklore.” The following is a list of questions that need to be addressed to provide the basis for a full biosafety, biocontainment, and biosecurity evidence base. These questions need to be addressed to provide the basis for a complete biosafety, biocontainment, and biosecurity evidence base. Often procedures are performed without sufficient forethought because “it's always been done this way.”A complete list of applied biosafety research priorities is presented in 1 Other issues include the lack of clear evidence for the recommendation that decontamination through gaseous fumigation be performed before recertification or other related procedures.Biological safety cabinets are a critical primary containment device. There is little evidence regarding the optimal frequency of biosafety cabinets and heating ventilation and air conditioning (HVAC) high-efficiency particulate air (HEPA) filter recertification; however, annual recertification is the norm.Facility biocontainment issues include the significant variation between leak rate measurement and airtightness between international standards and some controversy about what constitutes “adequate” air tightness. Furthermore, the impact of unscheduled laboratory HVAC system shutdown on biocontainment is not fully understood, and an appropriate operational response is required, considering the requirement for staff to exit the facility and the impact of the shutdown on the safe operation of biosafety cabinets/fume hoods. An analysis of the cause of unscheduled shutdowns including the use and abuse of emergency stop buttons should occur.The impacts of aging on biocontainment facilities are not understood, and an improved appreciation of the agent characteristics of commonly used materials need to be assessed in terms of being able to maintain their biocontainment effectiveness as they age .Showering out of high containment facilities is often required, especially where animals are housed. However, often this practice is extended to laboratories where there is no immediate risk of staff contamination. A better understanding of the evidence required for showering for specific pathogens is required. It is unclear whether the practice of showering is performed to remind staff to change their clothes before leaving the laboratory or whether it is conducted to remove pathogens from the surface of the individual's work clothes and skin.2An evidence base for showering out of a biocontainment facility significantly reduces initial costs during construction and ongoing operation and maintenance costs. Changes to showering out requirements would reduce energy costs and promote water conservation as part of operational and environmental sustainability.3; however, there remains a significant gap in the knowledge in this crucial area. Also, more robust scientific evidence regarding the selection, decontamination, and possible reuse of gloves and coveralls would be beneficial in low-resource settings.There is often conjecture about the correct order to remove PPE as there is inconsistency in the standard operating procedure depending on the type and requirement of the PPE and activities in question. A solid evidence base would clarify this matter. Detailed studies to determine the most effective methodologies for the reuse and/or decontamination of single-use PPE, such as N95 respirators and reusable elastomeric masks, have proven critical during the COVID-19 pandemicIn addition, the risks posed by new equipment such as Maldi-TOF or automated robotics systems processing large quantities of potentially infectious material are often unclear, which would also extend to decontamination procedures.There is a need to develop robust evidence base for standardized decontamination and disinfection recommendations. There is a lack of consensus regarding decontamination of surfaces and spaces. Furthermore, although decontamination and disinfection information is abundant for specific pathogens , there is often inadequate information for other important pathogens. Simplifying and standardizing surface and space decontamination would be enormously helpful to those practitioners in the field.4–6 the efficacy of different nucleic acid extraction methods for the most pathogens has not been established. Therefore, there is a requirement for studies to determine the efficacy of various DNA/RNA extraction methods to inactivate a range of infectious agents.The use of nucleic acid amplification techniques has revolutionized diagnostics. Nucleic acid extraction techniques are often assumed to inactivate pathogens in clinical samples without a robust scientific base. Although a number of studies have been published,The COVID-19 pandemic has highlighted the review of fomites as a potential source of infection. However, for many other pathogens, there is little evidence regarding the potential for infectious transmission on fomites, especially the movement of staff and equipment. Furthermore, the potential production of aerosols while performing routine laboratory activities, especially in clinical settings, requires further investigation to determine the actual level of risk to the staff. This includes using point-of-care testing systems such as lateral flow devices and Xpert MTB/RTF when testing various types of samples that may have high infectious loads, including sputum.Dried blood spots provide a convenient and straightforward method of collecting blood samples onto a permanent medium, such as filter paper at remote clinical sites that can be sent to a centralized location for testing. However, there is very little evidence regarding biosafety risks associated with storage, sample transport, and sample punch collections.7 indicating that there are viable alternatives to working safely with viral hemorrhagic fever samples in low-resource settings.A list of biosafety infrastructure priorities is presented in It should be recognized that often the building of the high containment laboratory, while being a source of great national or regional pride, and often, the technical aspects are secondary to this consideration. Therefore, overtime, the facility becomes a unsustainable burden on scarce financial resources, leading to increased biosafety and biocontainment risks.Developing a reliable workforce that is competent and confident to work in a laboratory with infectious materials is the cornerstone of biosafety. Training all laboratory staff in good microbiological practices and procedures, including regular updates on new information, is essential for the safe management of a laboratory. The training curriculum must include developing awareness of “dual-use” or “gain of function” research and the adverse implications of these activities. Reliability and competency go hand-in-hand in demonstrating best practices when working in a laboratory. Developing tools that can explain and quantify all aspects of this requirement would be helpful for implementation and monitoring.Biosafety as a vocation rather than an add-on to additional duties is essential. Staff need access to relevant training, preferably as an academic program for biosafety practitioners—not just an afterthought. At present, there is limited internationally recognized formal training for biosafety professionals. Furthermore, it is of paramount importance that biosafety professionals have a background in laboratory procedures, such as those who have previously worked in virology or bacteriology laboratories. There is no substitute for experience when making judgments on risk assessments.In addition, there is a critical lack of biocontainment engineers, especially in developing countries. Despite the proliferation of highly sophisticated biocontainment laboratories, especially in low-resource or developing country settings, there remains an acute and severe lack of biocontainment engineers to allow these facilities' sustainable management and maintenance. This problem is confounded by a lack of specific biocontainment courses for engineers, and often the only place to learn is on the job. This resource development also needs to extend to biosafety cabinet certification due to the rapid expansion of biosafety cabinets as a primary containment device.Those working outside of the infectious diseases area are surprised to find very few regulations, especially those laboratories working with highly pathogenic agents. Therefore, such laboratories' registration system is essential to monitor compliance with national and international regulatory adherence and allows enforceable minimum standards for laboratory safety based on sustainable standards.8 the United Kingdom,9 and several European Union countries, and for select agents in the United States;10 however, most other jurisdictions have no legal requirement for LAI or infectious incident reporting. To get an accurate estimate of the actual size of issues relating to infectious incidents resulting in infections of laboratory staff or environmental contamination, formal reporting systems are required. There is a role for international organizations to serve as an “independent” or “clearinghouse” for recording such information.With few exceptions, only a few countries require reporting of LAIs, accidental release, or other incidents. There are formal reporting systems in Canada,Institutional biosafety committees (IBCs) play an essential role in biosafety regulation in a practical and regulatory sense. There is generally a culture of IBCs regulating and reviewing biosafety matters within well-resourced settings and more regulated institutions. Leadership often views these as necessary administrative structures and performs an essential function in research safety and community stewardship. Unfortunately, because time must be invested in describing the work and the safe measures applied for risk reduction, some researchers view IBCs as impediments to progressing research, and their value is not seen in a positive light.The IBC should be promoted as a forum where biosafety elements and approaches can be raised and discussed without impunity to guide the end user and inform more safe practices while facilitating research projects. In less well-resourced settings or those that are not regulated, IBCs may or may not exist. When they are hastily composed and enacted, individuals without the requiste knowledge, experience, or skillsets may be selected as reviewers and the reviews are conducted in such a manner that they can be obstructive and punitive in their operation. There is an opportunity to guide and mentor new IBCs by local institutions with highly functional IBCs, local or regional biosafety associations, and international and governmental organizations.Biosecurity and biorepositories, especially sensitive or highly infectious materials, must be regulated regarding access and accounting. There is a regulatory requirement to do so, such as in the United States, United Kingdom, and Australia; biorepository programs are regularly assessed for security breaches or discrepancies. In many countries and institutions, there are no biorepositories, and quite often, there is no systematic method of storing infectious or sensitive materials.11 and WHO Laboratory Biosafety Manual 4th edition (WHO LBM4)12 do not encourage the use of pathogen risk or hazard groups but instead advocate a risk-based approach to biosafety. Therefore, it is reasonable to ask—what is the value of pathogen risk groups? As scientific evidence on routes of transmission, treatment, and vaccines become available, is there a need to rely on the pathogen “classification” in conducting a biorisk assessment, or should we be putting a greater emphasis on gathering all of the pertinent information on the pathogen, procedures, and exposure mitigation factors to inform a robust biorisk assessment?Pathogen risk groups have become biosafety shorthand to communicate the risk or hazard associated with a particular pathogen. The latest versions of the WOAH Terrestrial ManualEstablishing a solid evidence base for biosafety practices is essential to prevent the wastage of precious resources and provide a sustainable and safe environment for laboratory activities. The research priorities identified as an outcome of the WOAH BRM and identifying the critical infrastructure deficiencies offer a rationale for future projects and activities to strengthen biosafety and biocontainment when planning future projects and activities. There is an obligation on the global biosafety and research community to support these initiatives to provide a sustainable base for the future rather than perpetuate outdated and inefficient practices.


IPC recommendations targeted at community-acquired infection aim to prevent illness and subsequent hospital readmission. Cohesive guidance for parents of preterm infants has not been clearly established. The review objectives are to identify and map the global characteristics of IPC measures/recommendations for parents of preterm infants discharged home to the community.Infection prevention and control (IPC) is an evidence-based and practical approach to prevention of harm by infection  and the PRISMA extension for reporting literature searches in systematic reviews. Electronic databases will be searched and limited by publication year (2013-present day). Grey literature, reference lists and expert-provided sources will be searched against predetermined criteria. A minimum of two authors will independently screen evidence sources and chart evidence on a predetermined charting form. Sources including IPC measures, or recommendations for parents of preterm infants during discharge planning or in the community/home, will be permitted within inclusion criteria. Limits include human studies only and evidence from 2013-present day. Recommendations aimed at professional implementation will be excluded. A descriptive summary of findings will be presented, with diagrammatic and tabular representation.Collated evidence will guide future research which will subsequently aim to develop policy and enhance clinical approaches.https://osf.io/9yhzk.This review has been registered on the Open Science Framework (OSF) 4th May 2021, available at The online version contains supplementary material available at 10.1186/s13643-023-02236-y. The World Health Organization (WHO) defines infection prevention and control (IPC) as an “evidence-based” , “scientApproaches to IPC in healthcare settings include strategies such as hand hygiene, wearing personal protective equipment, social distancing, patient movement considerations , isolation areas, respiratory hygiene measures, increased environmental cleaning, consideration of ventilation such as opening windows and offering remote consultations . IPC pubThe WHO defines preterm as “babies born alive before 37 weeks of pregnancy are completed” . The orgSystematically reviewed reports of quality improvement for bronchopulmonary dysplasia (BPD) identified BPD (formerly chronic lung disease) as the most common morbidity in premature infants . A furthA 2020 Vietnamese cohort study found that of the 193 preterm infants studied from birth to 24-month corrected age, 47% were readmitted at least once in the first year and 22% in year 2. All causes across the 2 years were due to respiratory infections (70%) followed by other infectious diseases (15%), echoing findings of prior studies in high-income countries [Five-hundred eighty-three Canadian participants were surveyed in 2021, regarding parental knowledge of RSV and other respiratory infections in preterm infants, concluding that parental knowledge of prophylaxis eligibility criteria is essential to aid infection prevention and management . A transA preliminary search of MEDLINE (EBSCO host), PROSPERO and the Cochrane Database of Systematic Reviews was conducted, and no current or ongoing reviews on the topic were identified. This provides justification that there is appropriate evidence and significance to substantiate a scoping review on this topic. The review objective is to identify and map the characteristics  of IPC measures and recommendations for parents of preterm infants discharged home to the community. The assimilation of evidence identified in this scoping review will inform future research recommendations. From the proposed research recommendations made through this scoping review, further research around policy and practice to mitigate the risk of infection and re-hospitalisation would be possible.What IPC measures and recommendations are available for parents/caregivers of preterm infants during discharge or on discharge home to the community to mitigate the incidence of infection and readmission to hospital?i)What is the range (year and location) of evidence that is available regarding the knowledge provision of IPC measures/recommendations?ii)From the available evidence, what specific IPC measures/recommendations are documented (content)?iii)What are the characteristics of the IPC measures/recommendations, including the form, source, mode of delivery and the context of provision of information to parents?This review will consider evidence that includes participants or sources  who provide information regarding IPC measures/recommendations to parents/caregivers of preterm infants or parents/caregivers of preterm infants who have received IPC measures/recommendations. Preterm infants may also be participants in studies that provide IPC measures/recommendations for parent/caregivers. A preterm infant will be defined as a baby born at < 37 weeks’ gestation .The core concept is parent/caregiver implemented IPC measures and recommendations and infection risk mitigation in the community. Eligible sources must provide recommendations and or risk mitigation strategies, with the aim of prevention of community-acquired infection in the preterm child. Common IPC measures and recommendations include hand hygiene, reduction in contact with others and environmental cleanliness. There will be no restriction on the background of the provider or the mode or form of delivery.This review is not limited to provision of recommendations from a specific healthcare setting or organisation. The recommendations and measures to be included in this review may be recommended or provided prior to discharge of the preterm infant  or post-discharge but with intended implementation of such recommendations to be conducted within the home or community environment by the parent/caregiver. Evidence will be excluded if it pertains to implementation of measures in a healthcare setting, by a healthcare professional, or if the implementation is not intended to be provided by the parent/caregiver of the infant. Sources are not limited by geographical location.This scoping review will consider qualitative, quantitative and mixed-methods study designs and review pieces, for example systematic reviews. Evidence sources will be inclusive of grey literature and may include but are not limited to primary research studies, opinion pieces, conference abstracts, pamphlets, websites or blogs. Book chapters, dissertations and theses will be excluded from the review. The review will include sources of evidence from 2013-present day to capture recent innovations in neonatal care. Sources must be either written in the English language or have a translation available. Sources excluded by language will be recorded within the audit trail and reported to uphold transparency.The proposed scoping review will be conducted in accordance with the JBI Methodology for scoping reviews  and writA peer-reviewed three-step search strategy will be used , aiming An initial limited search of MEDLINE (EBSCO host) and CINAHL was undertaken to identify the breadth and availability of literature on the topic. This preliminary search strategy contained key words for population, concept and context. The text words contained in the titles and abstracts of relevant articles, and the index terms used to describe the retrieved articles, were used to develop a full search strategy for MEDLINE with the assistance of an academic librarian . Searches of grey literature will be conducted via databases and repositories. When required, the authors of the papers and experts in the field will be contacted for further information and to elicit knowledge of newly published sources. The search process will be iterative, and the search strategy may be modified to improve sensitivity and specificity. Any adaptations will be documented in an audit trail. Due to resource issues and translation feasibility, sources published in the English language or with an English language translation available will be included. Primary studies with an English language abstract will be included provided that appropriate information may be gathered. Studies excluded due to language will be recorded within the audit trail to uphold transparency. The search will be re-run prior to final analysis.A comprehensive search of electronic databases will be conducted including MEDLINE (EBSCO), Embase (Ovid), CINAHL (EBSCO), PsycINFO (EBSCO), AMED (EBSCO), Cochrane Library Online, ProQuest Nursing and Allied Health Source, Directory of Open Access Journals, Science Direct, Scopus and Web of Science. Sources of unpublished studies/grey literature to be searched via online databases include OpenGrey, MedNar, Grey Literature Report, Health Management Information Centre and PsychEXTRA. Search engines Google (pages 1–20) and Google Scholar (pages 1–20) will also be used. Further potential grey literature sources will include, but will not be limited to, the National Centre for Health and Care Excellence (NICE), the Royal College of Paediatrics and Child Health (RCPCH), Royal College of Obstetricians and Gynaecologists and third-sector organisations and business stakeholders (for example BLISS and Tommy’s).Following the search, all identified citations will be collated and uploaded into the EndNote 20  citationTwenty-five titles and abstracts will be selected at random.All reviewers will screen the 25 titles and abstracts using the eligibility criteria and stated definitions.Formal evidence screening will commence when a minimum of 75% accuracy has been achieved . An addiFollowing this, the titles and abstracts will then be screened by a minimum of two independent reviewers for assessment against the review inclusion criteria for all the papers. Potentially relevant sources will be retrieved in full and their citation details imported into the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI)  , 27. TheData will be extracted by a minimum of two independent reviewers using a data charting tool (Table 2 in Data will be descriptively presented using a narrative summary. Frequency counts of concept characteristics will be tabulated . Using tAdditional file 1.


Most of the controversial recommendations were related to initial imaging (with consensus on CT/CBCT as the current diagnostic standard for imaging), pharmacotherapy (no recommendation due to lack of evidence), discopexy (no recommendation possible due to low LoE) and timing of orthognathic surgery . Overall, the Delphi procedure resulted in an interdisciplinary guideline offering the best possible evidence- and consensus-based expertise to date in the diagnosis and treatment of ICR.Idiopathic condylar resorption (ICR), though a rare event, is associated with severe detrimental sequelae for the patient. To date, the etiology remains unknown, and treatment strategies are highly controversial. Therefore, the aim of this study is to present an analysis of the consensus- and evidence-based approach to ICR by a German interdisciplinary guideline project of the AWMF . Following a systematic literature search, including 56  publications, with a predominantly low level of evidence (LoE), two independent working groups  voted on a draft comprising 25 recommendations in a standardized anonymized and blinded Delphi procedure. While the results of the votes were relatively homogeneous, the interdisciplinary phase required a significantly higher number of rounds ( Idiopathic condylar resorption (ICR) is a very rare clinical entity that should be treated as a diagnosis of exclusion. While the resorptions observed can be attributed predominantly to a secondary genesis, these secondary condylar resorptions are usually also subsumed under the term “ICR” in clinical usage. Idiopathic condylar resorption is characterized by osteolysis of the mandibular condylar process. According to our literature search, the resorption process has never been described to progress deeper than the superior aspect of the sigmoid notch, i.e., the border between ramus and condylar process ,2,3.A differentiation is made between active (progressive) and stable (non-progressive) resorption. The disease usually affects both temporomandibular joints ,4; howevICR is a pathology observed mainly in women between the ages of 15 and 35 years ,9,10,11.In most cases of condylar resorption, the causes remain unknown, and different approaches to aetiology and pathogenesis result in differing views regarding the therapeutic approach to be adopted. Conflicting study results complicate consensus finding ,14,15,16Due to the comparatively low incidence, the current data on idiopathic condylar resorption are limited . ExistinConsidering the uncertainty among patients and practitioners resulting from the epidemiologically poor data, sufficient evidence and standardized approaches are still needed in many areas of clinical management, hence the great significance of the interdisciplinary, evidence- and consensus-based guideline published online in Germany by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften—AWMF) as an evidence- and consensus-based S3 guideline in 03/2023. The aim of this study is to identify and analyse the issues subject to controversial discussion during the development of the above S3 guideline, based on a systematic literature search and an interdisciplinary expert consensus of the mandated representatives of the contributing scientific societies.The foundation for the current guideline was the previous S3 guideline on ICR (06/2016), which itself represents a comprehensively updated and revised version of the preceding S1 guideline (11/2009) on ICR.www.guideline.gov (access date 16 June 2021) and www.nice.org.uk (access date 16 June 2021). However, no relevant guidelines addressing ICR could be identified.Initially, a search for national and international guidelines was conducted within databases, i.e., PubMed, Cochrane, AWMF, Both the initial and subsequent literature searches were conducted using the syntax “idiopathic condylar resorption [AND] temporomandibular joint”. The guideline working group decided against limiting the search to specific years of publication, study types or research questions due to the limited availability of relevant studies. The inclusion criterion was publication in the German or English language. The specific research questions resulting from the initial search were further explored using the PICOTS scheme.In addition to the 63 sources from the previous S3 guideline (06/2016), a further 47 sources were included in the guideline as part of the 03/2023 update. Titles and abstracts of potentially eligible records were reviewed and assessed by two medical experts independently (M.R. and C.V.), and duplicates and studies not relevant for the guideline were removed. A further selection was made from the remaining publications based on a review of their full text. Additional sources were included in the guideline after a manual search and following an update . In caseThe level of evidence (LoE) was assessed by two medical experts (M.R. and C.V.) independently, based on the Oxford Criteria 2011 . In casehttps://www.sign.ac.uk/what-we-do/methodology/checklists/; access date 29 June 2021) by two experts independently (M.R. and C.V.) and classified into four categories  as outlined in Based on the systematic literature search, and following the identical methodology as in previous AWMF guidelines ,21, an ihttp://www.awmf.org/leitlinien/awmf-regelwerk.html (accessed on 1 September 2022)) implemented by e-mail correspondence, which offered the additional advantage of an anonymized and blinded vote. During this process, participants had the options of assigning “shall”, “should” or “may” for “Strength of Recommendation”  and of abstention. Furthermore, participants had the opportunity to submit questions, and comments and propose text alterations. As were the results of the vote, these were presented anonymized in the subsequent rounds and voted on, if applicable. The results were assessed by an independent nonvoting member of the steering group (M.R.)  .Strength of recommendation (grade) was determined based mainly on the level of evidence but also took into consideration other criteria such as ethical, legal and economic aspects together with clinical experience, feasibility in everyday practice, benefit–risk analysis for those affected, and suitability for the patient target group and for the German health system . Recommehttps://register.awmf.org/de/leitlinien/detail/007-066, access date 3 April 2023).The final version was consented to in an interdisciplinary fashion by all the representatives of the participating specialist societies as well as by the DGMKG. After a structured consensus was arrived at by Delphi process, approbation of the guideline by the board of directors of the participating scientific societies followed and it was published online by the AWMF on 3 April 2023  vs. interdisciplinary consensus phase (K2)) regarding the variables “consensus” (in percent), “number of rounds”, “strength of consensus”  and “proportion of abstentions” (in percent). As “proportion of abstentions” remained unchanged between draft stage (K1) and interdisciplinary consensus (K2), this variable was dismissed.p < 0.05.For the purpose of calculations for the variables “number of rounds”, “consensus” and “strength of consensus”, the Mann–Whitney test and the Fisher’s exact test were applied, respectively. The level of significance was defined as www.guideline.gov (access date 16 June 2021) and www.nice.org.uk (access date 16 June 2021) did not produce any relevant guidelines addressing ICR.The initial search for national and international guidelines conducted in the databases PubMed, Cochrane, AWMF, The further literature search regarding publications on idiopathic condylar resorption returned a total of 97 records. After selection by title, abstract and full text, then after hand search and additional updates to the literature, a total of 56 sources were included in the guideline  were requested to participate in the guideline project on idiopathic condylar resorption. All seven members agreed to participate in the specific working group in the initial consensus phase see . The iniFurthermore, twelve scientific societies and four patient associations were requested to participate in the interdisciplinary consensus phase. In total, five scientific societies and no patient association agreed to participate see . The intIn the initial OMFS consensus phase (K1), 23/24 (95.8%) of the recommendations achieved a “strong consensus” and 1/24 (4.2%) a “consensus”. In the interdisciplinary consensus phase, 23/25 (92.0%) of the recommendations resulted in a “strong consensus” and 2/25 (8.0%) in a “consensus”.There were no statistically significant differences in the consensus percentages or the strength of consensus between the initial consensus phase OMFS (K1) and the interdisciplinary consensus phase (K2) see .In the initial OMFS consensus phase (K1), 11/22 (50.0%) of recommendations required a second voting round. In addition, two further recommendations were submitted in the third voting round, which also required a further round of voting. In the interdisciplinary consensus phase (K2), 9/25 (36.0%) of the recommendations required a second voting round.p < 0.001)  see .Consensus in percent is shown in the Strength of consensus is shown in Number of rounds is shown in Criterion 1: consensus not achieved (agreement <75%) in at least one round.Criterion 2: modification of text required to achieve a higher level of consensus (from “not approved by majority” (≤50%) to “approved by majority” (51–75%) or from “consensus” (76–95%) to “strong consensus” (>95%)).There was a need for prolonged discussion on certain recommendations and topics, resulting in a prolonged consensus process during the Delphi procedure. A voting result was defined as controversial according to the below criteria:According to these criteria, 9 out of 25 of the recommendations  could be identified as controversial in the Delphi procedure. Out of the total of same nine recommendations, consensus could not be achieved (agreement < 75%) in at least one round for seven recommendations, and a modification of the text was required to achieve a higher level of consensus in three recommendations. One of these, nine recommendations met both criteria.Diagnostics: three-dimensional imaging (CT/CBCT) for further diagnostics; three-dimensional imaging (CT/CBCT) to document initial presentation and disease progression; CT or CBCT for specific questions regarding bony structures; MRI scan for specific questions regarding soft tissue; and contrast-enhanced MRI scan to rule out or confirm an autoimmune or rheumatic disease as the cause of the ICR.Therapy: in cases of failure of conservative therapy, condylectomy with subsequent reconstruction; arthroplasty as a two-stage procedure, when required in combination with orthognathic surgery—in such cases, arthroplasty procedure first, followed by orthognathic surgery; total alloplastic joint replacement if adequate conservative and surgical measures prove unsuccessful; and reconstructive procedures in a single-stage approach if a combination with orthognathic surgical realignment is required.In terms of content, these controversial recommendations involved the following topics  is characterized by an altered shape  and decreased volume of the condyle and a 6–10% reduction in ramus height in conventional imaging ,25,26,27Direct comparison between patients who develop ICR postoperatively (after orthognathic surgery) and those who do not, however, reveals some significant differences. These concern the preoperative mandibular plane angle, which is significantly greater in patients who develop ICR, whereas the preoperative SNB angle, the overbite, posterior facial height and the ratio of posterior facial height to anterior facial height were significantly smaller .In this context, it should be noted that, according to the literature, resorption after orthognathic surgery manifests in conventional two-dimensional imaging at the earliest 6 months after and at the latest 2 years after surgery ,19.For further diagnosis and treatment planning or exclusion, both the OMFS and the interdisciplinary guideline groups unanimously established a strong recommendation  in favour of the use of three-dimensional imaging in spite of the low level of evidence available in the literature .Changes observed in advanced imaging and which may be associated with condylar resorption include osteophytes, disc dislocation, disc perforation and/or disc degradation, synovial hyperplasia, synovitis and loss of fibrocartilage . Such adA controversial topic identified during the consensus process is the method of choice for three-dimensional imaging in ICR. According to the international literature, both CT and CBCT are suitable for diagnosing the initial presentation and the progression of ICR ,30. Due According to Valladares-Neto et al., the pathognomonic loss of the cortical layer of the condyle, which is typically found in the erosion stage of idiopathic condylar resorption, can be assessed by both CT and MRI . In addiAgainst this background, we adapted our previous recommendations due to the good evidence available in the literature, and after consultation with the most competent scientific association with regard to questions concerning radiological imaging, i.e., the Deutsche Röntgengesellschaft e.V. (German Association of Radiology), which complied with our request for expert assessment and also became a member of the interdisciplinary guideline group. According to the consensus achieved, three-dimensional imaging (CT/CBCT) is the current diagnostic standard for imaging and the documentation of the extent of ICR, and for ruling out other differential diagnoses at initial presentation. Therefore, it should be used to document initial presentation and disease progression . Equally, in cases of ICR, for specific questions regarding bony structures, CT or CBCT, which are basically equivalent for this indication, should be used as diagnostic tools . Pathognomonic MRI findings of idiopathic condylar resorption include decreased condylar volume; anterior disc displacement with/without reduction of mouth opening; rarefaction or even loss of cortical continuity at the condylar surface; and thickened soft tissue with amorphous appearance occupying the intraarticular space between condyle and fossa ,11. The Another advanced imaging technique is scintigraphy. The potential additional benefit of scintigraphy for differentiation between the active and stable states of resorption has been critically assessed by some authors ,5,6,34. If secondary condylar resorption is suspected, i.e., with a disease potentially causative for the resorption, the aetiology should be clarified by appropriate advanced diagnostics .For example, the presence of inflammation, condylar erosion, and/or cartilage damage may suggest an autoimmune cause for resorption . Until nIf secondary condylar resorption is evident, treatment of the underlying disease should be pursued in the first place . If there is no underlying disease accountable for the resorption, there is also the option of starting with conservative therapy primarily. In addition to controlling symptoms, conservative procedures also may help decelerate the progression of ICR ,7. In a Conservative therapy measures include functional therapy  ,36, accoRecently, advances in pharmacotherapy have shown promising alternative interventions for deceleration of the progression of the disease, i.e., in reducing the extent of resorption. Whereas several studies have already indeed demonstrated good results of pharmacotherapy of rheumatoid arthritis of the temporomandibular joint ,39,40, tSurgical treatment may be indicated in the case of pronounced pain and massive functional disorders as well as for more serious deformities . However, timing and choice of surgical intervention remain controversial ,9,10,18.Overall, the evaluation of surgical procedures for idiopathic condylar resorption is only possible with significant reservations due to the small number of cases in the available studies.Basically, the following surgical procedures are available for the treatment of idiopathic condylar resorption: arthrocentesis ; arthropAnother highly controversial issue identified during the consensus process is discopexy, which—according to some authors—should be performed in conjunction with resection of hyperplastic synovia, if necessary ,11. In tAdditional new recommendations were established concerning the topic of temporomandibular joint replacement, both autologous and allogenic. Basically, both procedures can be considered.Nevertheless, if adequate conservative and surgical measures with autologous reconstruction fail, or if multiple surgeries have already been performed in the region, the indication for arthroplasty with total alloplastic joint replacement should be considered, if symptoms are sufficiently severe . In particular, if condylar resorption was caused by an inflammatory temporomandibular joint disease of the rheumatic type, this is seen as an indication for total alloplastic joint replacement ,34,47,48These recommendations regarding total alloplastic temporomandibular joint replacement were updated based on newly available studies with higher levels of evidence and supported by the respective recommendations of two recently published S3 guidelines  and rheumatoid arthritis (RA) of the temporomandibular joint”, register number 007/061).In individual cases, allogenic or autologous reconstructions of the condylar process and, if necessary, parts of the skull base, are combined with orthognathic surgery ,42,45,49In general, the objective of any surgical therapy for condylar resorption is to minimize further compressive loads on the condyle ,6,9, as In this context, another highly controversial issue necessitating thorough discussion among the members of the interdisciplinary guideline group was whether overloading/misloading of the temporomandibular joint may be caused by orthodontic treatment or orthognathic surgery, and thus whether orthodontic treatment or orthognathic surgery are among the risk factors for ICR. The incidence of condylar resorption after orthognathic surgery is reported in the literature to range from 1 to 31% ,13,25. HA limitation of the study was the low level of evidence of most available published studies on ICR, as became again particularly noticeable during the literature research. The level of evidence was determined according to the AWMF rules and standards and the Oxford Criteria of 2011. This represents a major limitation, which the guideline group had to consider when establishing recommendations. As a result, some recommendations could not be assigned a strong grade of recommendation (A), as this would conflict with the low level of evidence available. In part, this meant that unequivocal statements were not always possible.https://www.awmf.org/regelwerk/; accessed on 1 September 2022) to further clarify critical topics. This could save both time and resources without compromising the outcome.Another main limitation of this study relates to the Delphi process. As already analysed by Schmidt et al., this method, while offering the advantage of great flexibility to the members of the guideline group, is very time-consuming . At the Concerning the consensus process, the required number of rounds in the interdisciplinary phase K2 of the Delphi process was significantly higher than in the initial OMFS-exclusive Phase K1. This was probably caused by the heterogeneous composition of the interdisciplinary guideline group involving representatives from dental societies and nonsurgical societies.In summary, the Delphi procedure provided for a profound, evidence-based, interdisciplinary exchange of ideas allowing for the development of the best possible expertise in the diagnosis and treatment of ICR. A review of the existing literature revealed that while pathognomonic features of ICR can often be observed on cephalometric lateral radiographs, a large proportion of these cases are asymptomatic . Therefore, in ICR, it is of particular relevance to tailor therapy aims first and foremost to the patient’s symptoms and not primarily based on diagnostic imaging. It could also be established that three-dimensional imaging (CT/CBCT) is the current diagnostic standard for imaging and documentation of the extent of ICR. With regard to the surgical treatment of ICR, the issue of the small number of cases in the available studies persists, making evidence-based statements difficult. In the field of pharmacotherapy, current new therapeutic approaches are emerging, with long-term results and larger case series remaining to be evaluated. Furthermore, the guideline group discussed the procedure of discopexy in patients with ICR. Due to lack of studies of higher levels of evidence, no consensus could be reached, and future study results remain to be evaluated. To date, the aetiology of ICR is still unknown. Possible risk factors have already been identified, including orthognathic surgery. Whether condylar resorptions are a consequence of orthognathic surgery or merely occur in their context by mere coincidence requires further research.