The Thrombolysis ImPlementation in Stroke (TIPS) trial tested the effect of a multicomponent, multidisciplinary, collaborative intervention designed to increase the rates of intravenous thrombolysis via a cluster randomized controlled trial at 20 Australian hospitals . This sub-study investigated changes in self-reported perceptions and practices of physicians and nurses working in acute stroke care at the participating hospitals.A survey with 74 statements was administered during the pre- and post-intervention periods to staff at 19 of the 20 hospitals. An exploratory factor analysis identified the structure of the survey items and linear mixed modeling was applied to the final survey domain scores to explore the differences between groups over time.p < 0.01) in scores relating to hospital performance indicators, feedback, and training; for the intervention hospitals compared to control hospitals. There was a corresponding increase in mean scores regarding perceptions about the thrombolysis evidence and implementation . Sub-group analysis indicated that the improvements were restricted to nurses’ responses.The response rate was 45% for both the pre-  and post-intervention  period. Four survey domains were identified: (1) hospital performance indicators, feedback, and training; (2) personal perceptions about thrombolysis evidence and implementation; (3) personal stroke skills and hospital stroke care policies; and (4) emergency and ambulance procedures. There was a significant pre- to post-intervention mean increase (0.21 95% CI 0.09; 0.34; TIPS resulted in changes in some aspects of nurses’ perceptions relating to the evidence for intravenous thrombolysis and its implementation and hospital performance indicators, feedback, and training. However, there is a need to explore further strategies for influencing the views of physicians given limited statistical power in the physician sample.ACTRN12613000939796, UTN: U1111–1145-6762. Contributions to the literatureThis study demonstrated the ability of a multicomponent implementation intervention to influence the perceptions of clinical staff regarding hospital performance indicators, feedback, and training; and their individual perceptions about the evidence base supporting poststroke thrombolysis and its implementation.This change occurred in the context of a transient change in the proportion of patients receiving thrombolysis for acute stroke.This study illustrates the importance of exploring processes as well as outcomes in the context of implementation trials, in that a change in clinician perceptions was achieved alongside a transient change in clinical practice. This suggests the need to further explore the perceptions/practice nexus during implementation trials.Implementation of evidence-based recommendations is critical to delivering optimal clinical care to patients and achieving improvements in health outcomes . HoweverAcute ischemic stroke (AIS) is one of the leading causes of mortality and morbidity globally  and in AThe Thrombolysis ImPlementation in Stroke (TIPS) study investigated a multicomponent, multidisciplinary, collaborative intervention designed to increase rates of intravenous thrombolysis . The TIPTherefore, the study aimed to (i) assess the validity of the staff survey measure through the exploratory factor analysis of the survey and (ii) investigate whether the perceptions and practices of the physicians and nurses involved in the TIPS study changed as a result of the TIPS intervention and whether any changes were specific to the practice group (physician or nurse) and hospital location (metropolitan or non-metropolitan).The TIPS study recruited 20 hospitals across three states of Australia between 2011 and 2015. It evaluated the effectiveness of a multicomponent, multidisciplinary, collaborative intervention aimed at improving rates of intravenous thrombolysis , 17. TIPIntervention components were developed in accordance with the behavior change wheel  and straAll participating hospitals had a Stroke Unit or the staffing equivalent, and all were in the early stages of implementing intravenous thrombolysis. Participating hospitals included those that were publicly and privately funded and metropolitan and non-metropolitan based. Metropolitan and non-metropolitan hospitals were defined according to the Australian Standard Geographical Classification Remoteness Areas . EligiblEligible survey participants were identified by a staff member within each hospital responsible for the organization of stroke care, and this was usually a nurse (survey coordinator). Eligible participants were invited to participate via a combination of email and personal communication. All surveys were completed in hard copy and these were deposited in collection boxes. The survey coordinator provided data on the estimated number of eligible staff, the number of surveys distributed, and the number returned.The survey was made up of 74 statements and in the first section, respondents were asked to rate their agreement using a five-point Likert Scale: Strongly disagree, disagree, agree, strongly agree, and not applicable  and the This section was titled “Your Views on tPA” and included 60 statements in total. Of these, 11 were directed at physicians only, and seven were directed at nurses only. Statements investigated issues related to knowledge and skills in assessing AIS and eligible patients for intravenous thrombolysis, hospital policy, and performance indicators for stroke care, impact, safety, and barriers to intravenous thrombolysis, the hospital’s monitoring and feedback systems, its emergency service, the protocol used to identify, treat and follow-up patients with stroke, and staff skills levels and staff training facilities. An example of a Section A statement is: “This hospital has goals for improving performance in stroke care”.This section was entitled “About You and Your Workplace” and included 14 questions. Of these, three were directed at physicians only, and one at nurses only. Questions investigated a respondent’s age, gender, role within the hospital, and the number of years worked in a stroke unit and/or stroke care. They also investigated a hospital’s intravenous thrombolysis rate, pre-arrival notification system from the ambulance, responsibilities around data entry, the proportion of stroke patients seen by Emergency physicians, number of patients referred to stroke care, proportion treated with intravenous thrombolysis, and the respondent’s role and responsibilities around intravenous thrombolysis. An example of a Section B statement is “Does the hospital have arrangements in place for pre-arrival notification of stroke patients from the ambulance service?”The frequencies and percentages of the responses for each statement were examined. An exploratory factor analysis was conducted on all statements, except those with > 20% missing values or “not applicable” responses, as they were assessed as having limited relevance . A princFollowing factor analysis, each selected factor was defined as a domain. Domain scores were calculated for each participant, by summing all statement responses in a domain and dividing them by the number of non-missing statements. The total score for each domain for each participant was four. Likert responses were allocated a score of strongly disagree = 1, disagree = 2, agree = 3, and strongly agree = 4. Only those who responded to at least 75% of the statements within each domain were calculated a domain score .Separate linear mixed models were conducted for each domain score to identify whether staff statements differed in response to the intervention. Between-group differences in the change in mean staff responses from pre-intervention to post-intervention were assessed. In each model, the main effect for the intervention group and time were included as fixed effects as well a group by time interaction term. Baseline thrombolysis rate was also included as a fixed effect in all models to control for this factor. A random intercept for the hospital was included to account for the clustered design of the trial. To assess our secondary aim, similar models were also conducted separately by profession  and geographical location  to allow for assessment of these factors as potential effect modifiers. Due to violations in the assumption of homoscedasticity, robust errors were employed for models assessing domain 1 and 2 of staff barriers. For domain, three and four bootstrap estimation was employed due to violations in the assumption of normality.All 20 TIPS hospitals were invited to participate in the staff survey; 19 hospitals participated in the pre-intervention survey and 18 of those participated in the post-intervention survey. During the pre-intervention period, of the 1127 eligible staff, 503 returned completed surveys, whereas during the post-intervention period, of the 919 eligible staff, 414 returned completed surveys, equating to a 45% response rate for both surveys. Table Of the 48 statements included in the factor analysis, 33 statements were maintained representing four domains  from the pre- to the post-intervention surveys (Table p < 0.05)  Table .Table 3p < 0.05), 0.18 , and 0.18  respectively. This indicated a change in nurses’ perceptions toward hospital performance indicators, feedback and training, thrombolysis evidence base, and its implementation along with emergency and ambulance service procedure, which was not present in physicians. Moreover, the sub-group analysis based on emergency and stroke care physicians was also no longer significant.When comparing results between physicians and nurses, the domain 1, 2, and 4 mean scores in nurses showed a significant mean increase of 0.25  indicating a change in staff perception related to hospital performance indicators, feedback, and training. In domain 2, the mean score in the metropolitan hospitals showed a significant mean increase of 0.25 , indicating a change in staff perception related to the evidence supporting thrombolysis and its implementation. There were no significant differences in domains 3 and 4.When comparing results between metropolitan and non-metropolitan hospitals, the domain 1 mean score in the non-metropolitan hospitals showed a significant mean increase of 0.26 . However, the evidence does indicate that it can be challenging to change physicians’ perceptions about their clinical practice because they are long-standing and widely held [Failure of the TIPS intervention to change the perceptions of physicians may be due to limited statistical power  the experience of the staff involved in implementation interventions and intervention uptake/adherence to developing better and sustainable intervention for the future.The TIPS intervention appeared to have more impact on changing the perception of nurses than physicians, particularly in the domains of hospitals’ performance, and feedback and training and perceptions about the thrombolysis evidence and its implementation. This further reinforces evidence about how challenging it is to change clinical practice and to effectively and efficiently bridge the evidence-practice gap.Additional file 1. STROBE Statement.Additional file 2. Supplement 1. Domains selected by factor analysis. Supplement 2. Domains selected by factor analysis. Supplement 3. Conceptual sense for the Factor structure.


In order to elicit the knowledge, experience, and attitudes of individuals involved in disaster response with regard to evidence-based best practices, Evidence Aid and its institutional partners, Georgetown University and the Uniformed Services University of the Health Sciences, carried out a Policy Delphi study in 2015–2016.Purposive and snowball methods were used to select study participants. The Delphi study comprised two rounds of iterative questions, with the questionnaires completed online. In addition, participants at the Evidence Aid conference in November 2016 discussed the findings in focus groups. Excel was used to analyze the quantitative data and Glaser and Strauss (1967) to analyze the qualitative data.Thirty-six participants responded to the first round of the study, 165 responded to the second round, and 30 participated in the focus group discussions. The salient findings include 1) ensuring that all key stakeholders are engaged in planning for and responding to disasters in a collaborative, coordinated manner—including local community members; 2) using, insofar as possible, evidence-based responses; 3) increasing and strengthening research to ensure that such data are available; and 4) addressing ethical, legal and social issues throughout the planning, immediate response, and post-disaster periods.Recent humanitarian disasters, due to natural and man-made hazards or a combination of the two, reinforce the need for more effective, efficient, humane responses at the local, national and international levels. This study has yielded findings that can be used to strengthen planning and response by taking into account, where possible, evidence based on research that has been carried out with the engagement of community members and with support by key stakeholders. The most effective means of facilitating the development and implementation of consistent, coordinated policies and practices might be for the United Nations Office for Disaster Risk Reduction to take the lead in engaging key organizations in the required discussions and collaborations.The online version of this article (10.1186/s12913-019-4102-5) contains supplementary material, which is available to authorized users. Disaster planning and response has been largely based on long-standing practices, notwithstanding the fact that for more than a decade there have been calls for evidence-based practices (e.g. ). The paWe investigated this broad question using the Policy Delphi technique, a policy analysis method designed to engage groups of experts (with experts being broadly defined) in dialogue regarding a single issue or multiple issues related to a particular topic. The Policy Delphi approach entails a series of rounds of iterative, structured dialogues , with each building on the other. Initially, questions are posed and the respondents answer anonymously. The responses are then summarized and used as a basis for the questions posed in the succeeding rounds. Questions may be added to move toward a rich and substantive dialogue in the study.Policy Delphi has been widely used in disaster management since the early 1970s, when it was first developed by the US Office of Emergency Preparedness. In contrast to the traditional Delphi approach, it does not seek consensus, but rather explores alternatives and their implications. In the health field, Policy Delphi has been used to address ethical, legal and social issues in biomedical and behavioral research, to forecast medical technological developments, to consider drug abuse policy, to plan for organizational and professional priorities, to develop national health priorities, and, at the community level, to engage communities in developing local health systems plans e.g. –5)..5]).The purpose of this study was to engage a wide range of key stakeholders in dialogue regarding various elements of disaster response, including, for example, evidence for best practice, approaches to improving investment with systematic review analysis of evidence, identification of gaps in the evidence base; and factors that impact on effective disaster response. It builds on earlier needs assessment and priority setting exercises by Evidence Aid , 7, whicTo what extent is evidence for best practices in disaster response available to a wide range of stakeholders?To what extent is Cochrane-style (systematic review) analysis used to assess evidence for best practices in disaster response?What are the most effective approaches to improving the cost-effectiveness of investments in disaster response?How can the ethical, legal and social issues related to disaster response decision-making be most effectively addressed?What are the factors that impact on effective disaster response decision-making?This Policy Delphi comprised two rounds, with the first and second being completed online using SurveyMonkey. In addition, participants at the Evidence Aid conference in November 2016, in Washington DC, engaged in focus groups to discuss the findings. The Policy Delphi was designed collaboratively by the planning group for the study, which comprised individuals from Evidence Aid, Georgetown University (GU) and the Uniformed Services University of the Health Sciences. The GU Institutional Review Boards (IRB) approved the study, and GU disseminated the two rounds of questionnaires through SurveyMonkey, conducted the analysis, and served as the location for the Evidence Aid conference. The broad research questions were:Participants were selected by the study-planning group using a purposive sampling method; that is, we identified individuals who had published in the field of disaster/humanitarian response, who were public officials or representatives of NGOs engaged in the field, or who had participated in Evidence Aid conferences or other events related to disaster/humanitarian response. For the first round, 135 individuals were selected as potential respondents. For the second round, 237 potential respondents were selected, including the original 135 to whom the first round was sent.An invitation email that included an informed consent script was sent to the initial 135 potential respondents, with a link to the questionnaire. The first-round, semi-structured questionnaire which was developed for this project  reported working for an institution other than those listed . Nearly one-third (31%) of respondents in the first round reported working primarily at an academic institution or university, while 25% of respondents did so in the second round. Other respondents described their primary place of work as being involved in international development (11 and 6%), private sector non-profit organizations, other than development assistance (11% in both the first and second rounds), national government work generally (11 and 15%), government agencies involved in the provision of or support for international aid or development projects (9 and 1.3%), or private sector non-profit development assistance (9%). The categories mentioned by less than 9%  but at least two were national government, health agency and national government other. In both the first and second round, some respondents indicated multiple roles.When asked to specify their role in the organization with which they worked, 35% of first round and just 11% of second round respondents described themselves as researchers; 29 and 12% as professors or teachers; 21 and 13% as consultants or advisors; 18 and 28% as being involved in either administration or management; and 12 and 10% as clinicians. Nearly one-fifth (18%) in the first round and more than one-fourth (28%) in the second round selected the “Other” option, with the self-identified descriptions being primarily the same in both rounds: program manager/emergency manager, technical specialist, director of research, public health program coordinator, science and technology adviser.There was a difference between the two rounds in geographic location of the respondents: in the first round, one-fourth were based in the United Kingdom (25%), followed by the United States (17%), India (8%), and Switzerland (8%). In the second round, most reported being based in the United States (77%) followed by the United Kingdom (4%). Eleven participants did not respond to this question in the second round.There was agreement among the 36 respondents that international and multi-national organizations, as well as national governments and NGOs could strengthen their response to disasters by using available evidence, and that systematic reviews should be used to synthesize evidence of disaster response effectiveness. Most believed that, although research-based evidence is preferable, for the most part it is ‘best practice’ information that serves currently as the basis for disaster responses determined by decision-makers and practitioners. Most respondents also believed that improvements in co-operation/co-ordination among disaster relief agencies in the collection, analysis and dissemination of data and information regarding disaster response would improve disaster response. Indeed, co-operation and co-ordination among all key stakeholders was a consistent theme through the first round responses, with respondents noting that this would contribute to improving social return on investments in disaster response, for example. Respondents believed that, although there are major impediments to effective and equitable disaster response that derive from both the country in which the disaster occurred  and external factors , these impediments can be addressed through the use of evidence-based policymaking and specific disaster-responses.The 165 respondents to the second round consistently identified three factors that facilitate the development of ‘best practices’ for disaster planning and response: 1) increased accessibility to scientific evidence; 2) improved communication among stakeholders; and 3) engagement of multiple beneficiaries in the decision-making process. Most respondents believed that policy and decision-makers need to be educated about research to effectively implement evidence-based policy. Many respondents believed that accessibility to information at all levels can be challenging. They also believed that overcoming communication and financial barriers as well as problems with distribution of information can improve accessibility of information to ensure evidence-based decision-making. Furthermore, co-operation and co-ordination among all key stakeholders and beneficiaries was a consistent theme through the responses.Participants suggested that policy makers should focus on dissemination of evidence related to disaster planning and response, communicating data, and creating a clear chain of command. Funding for research regarding disaster response and strengthened systems was also a concern. This would necessitate a clear plan and strengthening the capacity of all those involved, based on evidence. Participants identified lack of co-ordination between and among NGOs, stakeholders, local authorities and donors as both a key issue and a need that must be addressed with evidence insofar as possible. This included co-ordination regarding 1) assessment of needs and evidence-based practices ; 2) strategic planning for disasters; and 3) responses and follow-up assessments. Educating the stakeholders on the evidence-based responses and creating a universal standard (or models) were also essential to better planning for and responding to disasters, as was promoting a free flow of information to all, in particular populations affected by disasters.Use of Research-based Evidence to Strengthen Disaster Responses;Perceptions of Ways that Ethical, Legal and Social Issues Related to Disaster Response Decision-Making be Most Effectively Addressed;Factors that Impact Effective Disaster Response Decision-Making; andChallenges and Approaches to Overcoming the Challenges of the Expected Outcomes of the United Nations International Strategy for Disaster Reduction (UNISDR) Road Map for Implementation of SendaiIn the following sections, the results of the two rounds of the Policy Delphi and the focus groups are presented by the topic areas addressed:The nature of the evidence for disaster response is primarily best practice information rather than research-based evidence.It is possible for national governments to achieve better social return on investment in disaster response by implementing actions or interventions that are based on research evidence.It is possible for international and multinational organizations to better achieve social return on investment in disaster response.Cochrane-style systematic reviews should be used in a standardized way to synthesize evidence to inform contextually specific evidence of effectiveness in disaster response.Overall, respondents agreed (mean: 4.0–4.5 out of maximum of 6) with the following statements:The analysis of answers to questions related to research-based evidence to strengthen disaster responses yielded four themes: 1) availability of evidence for best practices in disaster response; 2) most effective ways to improve the applicability of research-based evidence for pre- and post-disaster planning; 3) most effective ways to ensure that ‘best practices’ inform the design of disaster-related research to prove evidence of effectiveness; and 4) improving the applicability of research-based evidence for pre- and post-disaster planning. If a question was posed in only one round, this is mentioned in the findings. Otherwise, comparisons between rounds are presented.Individual participants mentioned increased research- and evidence-based case studies, more specific and thoroughly researched interventions, and universal access to this information as examples of how this could be accomplished. Responses about the nature and quality of research-based evidence for disaster response suggested that the disaster response community may be divided regarding their perceptions of the reliability of research based-evidence as the basis for strategic planning by national governments or international development agencies.only when it has been peer reviewed, published, and critiqued”.Of the 36 respondents to Round 1, 21 (58%) either completely or strongly agreed with the statement that ‘[t]he nature of disaster response is primarily ‘best practice’ information rather than research-based evidence’ (58%). The remaining participants ‘somewhat agreed’ (six participants), ‘somewhat disagreed’ (two participants), or ‘completely disagreed’ (one participant) with the statement. Three participants did not provide a response. An overall mean rating of 5 suggests that the respondents believe that best practice information rather than research comprises the basis of ‘evidence’ currently used in disaster response strategic efforts and planning. There was no consensus regarding the statement that research-based evidence for disaster response is sufficiently reliable to warrant its use as the basis for strategic planning by national governments. Indeed, one respondent suggested that international agencies should use evidence “Responses suggested that the disaster response community may be divided regarding their perceptions of the reliability of research-based evidence as the basis for strategic planning by either national governments or international development agencies.Of the 165 respondents who participated in the second round, 109 (83%) thought that one of the most effective methods to address this issue was for potential users of research related to pre-disaster planning  to be involved in the design and/or implementation of the research. This response was also selected as one of the most effective ways to improve applicability of research-based evidence for post-disaster planning by 104 (80%) respondents. Ensuring that research related to planning is decision-linked was chosen by 74 (57%) respondents for pre-disaster planning and by 70 (54%) respondents for post-disaster planning. Ensuring that comprehensive research is carried out  was selected by 77 (59%) respondents as another effective way to improve the applicability of research-based evidence for post-disaster planning and by 65 (50%) respondents for pre-disaster planning.When talking about evidence, we need to make sure that it is context-specific” for pre-disaster planning.Open-ended responses to this item suggest both an emphasis on collaboration with various parties and the use of gap analyses to identity areas of vulnerability for pre-disaster planning. 45 (34%) participants selected and wrote that multiple research methods should be used for pre-disaster planning, with one stating, “Respondents’ suggestions for post-disaster planning emphasized ways to disseminate information and the importance of using evidence-based research to improve policy. Ensuring that the research is guided by priority setting or gap map exercises with a substantial methodology was a goal chosen by 48 (37%) participants. Many respondents mentioned the importance of having researchers ‘directly engage and actively participate with ‘the local community’, ‘subject matter experts’, policy makers, and planners to improve the applicability of research-based evidence for post-disaster planning’.work with one group to make a good example of use of best practice information, and then publish the case study”.Of the 66 respondents for this question, three quarters (76%) chose ‘ensuring that research-based evidence is available at no or minimal cost’ as one of the most effective ways to ensure that ‘best practices’ inform the design of disaster-related research to prove evidence of effectiveness’. More than half (55%) also chose the dissemination of ‘best practice information’ related to disaster planning and response through international and national associations of related professionals  only if that information had been critically reviewed by an approved body. Nearly half the respondents (48%) selected ‘dissemination of ‘best practice information’ related to disaster planning and response through a central, global network only if they have been critically reviewed by an approved body.’ One respondent suggested that, rather than focusing on disseminating information, there should be an emphasis to “prefer an open discussion since information, whether proven valid or not, may spur innovations into disaster and emergency planning, response and recovery”. One respondent suggested that evidence-based data should include qualitative information, which “should always be a great part of the disaster reviews”. Another wrote that using standardized reviews would help “regional governments to prioritize the focus of systematic review. I also believe that there is still a dearth of peer-reviewed evidence relating to disaster response [and] we need to be more open and find better ways of synthesizing grey literature”.As a follow-up question, respondents were asked whether evidence regarding disaster planning and response should be used only if it is peer reviewed, published and critiqued. Many (42%) indicated that all those processes should occur if the evidence is going to be used. Others (29%) indicated that it should be peer reviewed, while 22% of participants chose that it should always be published and 20% that it should be critiqued. Ten respondents indicated that while published and peer-reviewed literature is ideal, it is important to consider other information as well. One respondent said that they would “ensure that the policies established are aligned with practicality on the ground”.Respondents were asked to describe how potential beneficiaries  should be engaged in research related to disaster planning and response while considering the lifespan of research that runs from the selection of priorities through designing and implementing the research to disseminating its findings. All 54 respondents who answered this question suggested that policy makers, planners, and government officials should be engaged in the research process. Sixteen respondents emphasized the importance of making sure that policy makers are educated about research findings and adequately prepared to make decisions and to develop policies. Seven respondents mentioned that policy makers should have a role in ensuring funding allocation for research related to disaster planning. Suggestions about the role of government officials focused on education and providing input in regards to funding, policy, and advocacy. Ten respondents mentioned that planners should determine the practicality of plans or policies. One respondent said that planners should “Most (39 of 40) respondents who answered this question suggested that other public employees and local NGOs ‘should be informed of the results in ways that are relevant to them’. Seventeen of 40 respondents suggested that other public employees be educated in results and plans when it is applicable to their role. Similar suggestions were offered for local NGOs. Ten of 41 respondents mentioned that local NGOs should be involved in research, whether through participation in the study or designing the research if that would be relevant to their role.open forums to help guide research topics”. Another respondent stated that all the listed potential beneficiaries of disaster response “need to have active outreach for their input, however, not all need to be invited into the process from the very beginning” to suggest a time-appropriate engagement of each stakeholder. Other suggestions included professional data collection organizations, healthcare organizations, and academic institutions as sources of research data and information. Two respondents also suggested engaging the media.On the other hand, respondents suggested that individuals and populations affected by disasters should be engaged in the research process as informants and consultants in regards to priority planning and implementation. Eighteen of 42 respondents suggested that those affected should be included as stakeholders through various parts of the process, such as the development of the research question, data collection, and the design and implementation of the project itself. One respondent said that those affected be involved in generating “When asked how the potential beneficiaries of disaster-related research should be engaged in applying research findings related to disaster planning and response to strengthening their capacity to plan for and respond to disasters, similar responses were given for all potential beneficiaries. Respondents placed emphasis on political influence for planners (15), policy makers (13), and government officials (8). Again, respondents mentioned engaging public employees and local government officials if it is applicable to their role. Those affected by disaster were also deemed to have a valid role as research informants and consultants.Nine questions elicited beliefs concerning social returns on investment in disaster response and the potential of evidence-based research to improve upon them for national governments, international and multinational organizations, and local NGOs. One of these questions invited respondents to rate their agreement with the statement that it is possible for national governments to achieve better social return on investment in disaster response by implementing actions or interventions that are based on research evidence. The average rating was 5 on the six-point scale, indicating that respondents believed that research-based evidence could improve social returns on investments by national governments in disaster response efforts. When asked to provide up to three examples of how this could be accomplished by national governments, 11 respondents mentioned strengthening research related to evidence-based practice in disaster responses, including for example, providing additional funding, training researchers, and conducting specific types of research. The latter include research related to the Disability Adjusted Life Years (DALYs) or Quality Adjusted Life Years (QALYs) of interventions. Few respondents indicated that they believe that national governments could not improve return on investment by research-based interventions. The reasons provided were wide-ranging, including the belief that disaster responses are essentially ‘common sense’ and should not be ‘academic’, that the evidence is ‘just not there’ and that the decision-making process is inherently political. One respondent suggested that the full support of the United Nations is required.Respondents similarly agreed that international non-profit organizations could improve social returns on investments by using research-based evidence for disaster response investments (mean rating: 4.71). With respect to the potential for non-profit organizations to improve evidence-based responses, most respondents (10 of 15) mentioned co-operation/co-ordination. Additional and/or improved evaluation and research related to NGO responses were recommended by eight respondents, and strengthened implementation of disaster responses by seven, with suggestions including investments in disaster mitigation and in community-level actions.agendas present within multiple multi-national organizations may hinder benefits to all social groups”.A similar question addressed the potential for research-based evidence to produce greater social returns on investments in disaster response for international organizations. There was relatively strong agreement with this statement as well. Co-ordination and co-operation were also the primary ways that respondents suggested that international and multinational organizations can improve disaster response, suggested by 28 respondents, including, for example, ‘strengthening partnerships between academicians, civil society and government bodies’. Eleven respondents suggested improvement in the use of evidence and in planning for disaster response. Specific examples included flexibility in assistance such as unconditional cash transfers that allow for beneficiary choice. Evaluating and conducting research regarding disaster response to yield evidence regarding best practices was suggested by 10 respondents. Other suggestions included focusing on the needs of vulnerable populations. Only one respondent did not believe that it is possible for international organizations to improve their disaster response, with the explanation that “A survey that focuses on response is missing the point that most effective measures to reduce health consequences lie in prevention and building the capacity of countries, communities and the international community before an emergency and disaster”.Twenty-five respondents answered the question asking for up to three ways that knowledge and evidence derived from research could be used to inform decision-making in disaster response. Most of these suggested improvements in evaluation/research related to disaster response, with respect to the quality of the studies, an improved focus on decision-linked, relevant questions/research, ensuring that the findings are accessible, or dissemination of the findings to decision-makers and engaging them in discourse regarding the findings. Nineteen respondents suggested improvements in the practical application of evidence, including for example, educating policy makers regarding evidence-based practices, ensuring visibility of the findings (e.g. conducting conferences and seminars among user groups), and linking domestic/national-level responses with international responses. Co-operation was mentioned by seven respondents specifically and was a theme through many of the other suggestions. One respondent commented that: “conducting research into whether or not different approaches to triage are better for victims and responders”. Other respondents suggested improved infrastructure, greater public awareness, and reviews of financial reports of aid organizations to which contributions are made for the disaster response.Sixteen respondents responded to the item related to ethical issues; six of these provided examples that related to triage of populations and areas that are affected. A few respondents (6) suggested that research should be used to more effectively address the ethical issues of triage. One respondent suggested that “when to respond and who should respond from outside the country”. Responses pertaining to ways that ethics has been adequately addressed varied. Five participants mentioned enhanced training in ethical decision-making as well as collaboration with bioethicists. One wrote that “establishing crisis standards of care protocols” is a way that the issue of resource allocation has been addressed.Five respondents commented on the ethical issues related to allocation of resources, with one noting the role of leadership in determining “judicial authorities”. Other participants (3) mentioned observing how individual states have addressed the issues of consent.Over half of the 18 respondents who addressed legal issues provided examples related to liability with respect to healthcare professionals who volunteer to help with disaster response and the safety of first responders. Other examples (4) mentioned were difficulties of consent related to quarantine, loss of identification, record keeping, and the use of human subjects in research. Responses (6) related to ways that the legal issue has been addressed include collaboration with international agencies, local public health organizations, as well as “developing clear policies within international organizations” is one way to address the issue of liability. Another offered that political will is key to developing evidence-based disaster preparedness plans. In regards to research, one respondent said that research related to liability should be on the “legal responsibility in international disasters”. In relation to the issue of consent, one respondent suggested that people being studied in research should be part of the design phase.Suggestions for the ways legal issues can be addressed more effectively with improved evidence related to policy (4) and research (4). Some responses related to policy related to the legal and liability issues that could arise. One respondent stated that “understanding gender roles [can] impact how societies respond to disasters”. The suggestions for ways these issues have been addressed vary. Two responses related to the issue of gender involved research. One respondent specifically mentioned that “qualitative research is at least identifying some of these issues and their importance in responses”. Four responses related to collaboration that involved government officials, insurance companies, general community members, and religious organizations.Of the 13 social examples provided, five related to resource and economic disparities while three related to gender. A participant noted that the disparities should be addressed across countries and within communities. In regards to gender, one respondent explained that “we have the systems, technology and the scientific methods to deliver this global target” of enhanced disaster response and preparedness. Another suggested “inclusive and collaborative policies” while another mentioned how the evidence could be used to “address health or social issues identified in the research”.The responses for how social issues can be more effectively addressed through improved evidence varied. Four respondents discussed improved training and technology. For instance, one mentioned ensuring that “Political Influence of the government in which the disaster occurred.Sociological trends in the country in which the disaster occurs.Post-colonial linkages between donor countries and countries affected by disasters.Global economic influences in the country in which the disaster occurs.Economic influences of the country in which the disaster occurs.The first Delphi round included a request that respondents rank what they considered the most important five of 15 factors presented for consideration in terms of their impact on the effectiveness of disaster responses, with 1 being the most important factor, 2 the next most important factor, and so on. The five factors that received the total lowest scores—that is, that respondents considered the most important—were:Respondents were invited to identify other factors that were not included in the list of 15 as the most important impact on effective disaster response decision-making. Six respondents suggested a total of 10 other factors. Three suggested accountability or capacity  as critical factors. The nature/magnitude of the disaster was mentioned by two respondents. Other factors mentioned were the clear message that scientists could use to inform policy and practice, and the economic and health impacts within the country in which the disaster occurs and those with trans-boundary impact as well.Respondents were then asked to indicate, for each of the five factors that they considered the most important, whether they believed that each had a primarily positive, negative, or mixed impact on the effectiveness of disaster response. All the original list of 15 factors were selected by at least one respondent. For 12 of the 15 factors, most respondents indicated that the factor had both positive and negative impact. For three of the factors, the respondents believed that there was primarily positive impact. These are: political influences of non-profit organizations of the country in which the disaster occurs; international legal factors, including for example laws and regulations regarding local NGOs, reconstruction and engagement; and ethical factors, including international guidelines regarding allocation of resources related to disaster relief.Ensure early  outreach to establish alignment of political influences with research based...best practices”. Referring to one aspect of the politics of disaster relief, one respondent suggested that “…there is nothing ‘potential’ about competition for funding among international relief organizations. It’s real and potent”. Creating and sustaining dialogue and ensuring accountability among the key actors were mentioned by most of these respondents. Ten respondents mentioned the need to strengthen the capacity of key stakeholders, from policy makers to emergency response personnel. One respondent specifically referred to the Sendai Framework for priorities.Respondents were also asked to suggest ways that the factors they identified as the most important could most effectively be addressed in the context of disaster relief. The suggestions of the 13 who responded to this request all centered on the need to improve policy-making and implementation of disaster response, including concerning evidence-based approaches. However, within these parameters the suggestions were wide-ranging, with a focus on improving the coordination among and responses by the donors , and considering political will when planning for and implementing disaster response. One respondent suggested, “accountability for disaster planning and response related to education (7) and evaluation (5). In terms of evaluation, a respondent suggested developing “post intervention studies [that] can help provide feedback to the concerned authorities”. Another said that “If we had evidence on best practice in disaster response and planning - we could use this as a way to evaluate and thereby ensure accountability”.The main suggestions for the most effective way for best practices and improved evidence to be used to help ensure The UNISDR Sendai Framework for Disaster Risk Reduction 2015–2030 was adopted at the Third UN World Conference in Sendai, Japan, in March 2015 with a goal of “The substantial reduction of disaster risk and losses in lives, livelihoods and health and in the economic, physical, social, cultural and environmental assets of persons, businesses, communities and countries” . This rocapacity for knowledge creation and exchange through local/non-local and expert/non-expert partnerships and community involvement” as a potential approach to enhance support in this area. Other issues mentioned by respondents related to access to information (5) and funding (4).When asked to present a challenge with assessing and updating the current state of data, scientific, local and indigenous knowledge as well as technical expertise availability on disaster risks reduction and fill the gaps with new knowledge, some respondents (12) mentioned challenges in regards to reviewing the data and personnel to perform this review. These respondents suggested enhanced support and tools as a solution to issues with reviewing the data and personnel. One respondent suggested building “provide other means of communication for dissemination of scientific evidence,” “prioritize knowledge needs based on the situation for policy makers,” and “translate into effective, non-technical information”. The overall solutions suggested that needs-based data should take priority and that multiple groups of people should have access to and be able to comprehend the data.Most (18) respondents presented challenges that related to accessibility of science evidence in terms of applicability to specific countries, target audiences of the study reports, and the length of time to find and publish new data. Solutions to the challenges included “key actors [are] unaware of scientific data/unable to keep abreast of new research”. Participants presented solutions that pertained to enhanced dissemination of information and that focused on increasing involvement in the research and planning processes. Issues with reviewing the scientific data and information were mentioned by 13. One participant specifically asked, “how do we verify if the data and information was used during a disaster?” He/she suggested providing “a reporting requirement that [specifies] which portions of the data and information were used and to what extent” to reduce the risk of disasters. One respondent mentioned that participants should be ‘incentivized’ and another suggested “acquiring passionate stakeholders in a dedicated committee”.Respondents (16) identified accessibility as a challenge in regards to ensuring that scientific data and information are used to monitor and review the progress towards disaster risk reduction and resilience building. The challenge of accessibility was defined in terms of ensuring all potential implementers and beneficiaries have access to the evidence as well as the ability to comprehend and implement it. A respondent described the challenge of accessibility as that “lack of ability to interpret and practically apply scientific information”. The solutions suggested for this challenge included generating ‘continued partnerships between researchers and emergency preparedness and response personnel’. Solutions to the problem of communication barriers varied. Some participants suggested forming a global consortium of information, to make the data available at a low cost, or to offer ‘specific financial and competence aid in this area,’ and another suggestion was to ensure that ‘research is truly designed to impact needs’.Most (18) respondents indicated that communication barriers would present a challenge to ensuring that all sectors and countries have access to, understand and can use scientific information for better informed decision making. Communication barriers included trust, language, and cultural differences. Some of these same respondents (8) also expressed that these communication barriers lead to a lack of evidence-based action. One participant indicated that a challenge is the “Approximately one-third (9 of 29) of respondents mentioned issues with distribution of information to support a stronger involvement and use of science to inform policy- and decision-making within and across all sectors. The challenges with distribution of information included ‘getting the information out across all sectors,’ ‘the use of evidence at all levels,’ and the fact that ‘many participants do not have this knowledge and need to be informed’. Solutions to these specific challenges included academic training, implementing ‘more research related to [the] impact of different strategies,’ and incentivizing participants. Two participants also mentioned that ‘tradition and past practice have a strong resistance to change’ and that the ‘acceptance of science to develop policy and decision making’ pose ideological challenges that inhibit a stronger involvement and use of science in policy and decision-making. Solutions to these challenges included identifying examples of effective use of science in policy and decision through identifying ‘champions in various sectors who will advocate for evidence-based policy-making’ as well as using science-based policy related to indigenous populations as examples of how policies should or should not be implemented. Nearly half (13 of 29) of respondents presented solutions related to generating enhanced support of evidence-based policy through education and the incorporation of political contexts.on one or two areas of highest priority – lower the bar for scientific evidence, if possible”. Other challenges included the view that “vulnerable communities have few decision-making resources” and that there is a “lack of involvement of primary stakeholders, therefore a lack of evidence on what works for different vulnerable groups”. Solutions for challenges related to these issues included increasing education efforts and encouraging involvement from stakeholders. Over half (16 of 29) of all respondents suggested education and enhanced engagement as solutions to the challenges to providing scientific evidence to enable decision-making of policy options for investment and development planning for vulnerable communities and locations.Challenges presented by respondents were varied and reflected many of the challenges mentioned above. Some (6 of 28) respondents selecting this UNISDR outcome mentioned that gaining evidence about vulnerable populations is a challenge. One respondent presented the solution of focusing “The challenges to this UNISDR outcome that the respondents suggested varied, but 11 of the 27 respondents presented issues that related to a lack of understanding and accessibility of information. Other suggestions (10) indicated issues related to educating stakeholders, such as policy and decision makers, about the needs of vulnerable populations. Four respondents mentioned that funding would pose a problem to obtaining this outcome. Most (12) solutions suggested enhanced education and engagement. One solution included the importance of listening ‘to the needs of the policy- and decision makers, and craft the implementation of the scientific data and information to align with existing local/indigenous authorities’ goals’. Four mentioned involving the local community as a specific type of engagement.Co-ordination was a principal theme in the first round, when most respondents (27) suggested that improvements in co-operation/co-ordination among disaster relief agencies in the collection, analysis and dissemination of data and information regarding disaster response would improve disaster response. Fewer responded that improvements in disaster response would come from improvements in funding for research to yield evidence (20) or increased use of evidence in planning and implementing such responses (9).involving them [all stakeholders] in research”. Another respondent mentioned “more inter-agency research” within the private sector and community engagement for the public and private sectors.Over a third of respondents (11 of 29) respondents suggested methods that relate to communication among stakeholders, such as ‘open, honest communication’, the use of ‘pre-established communication channels’, and ‘congeniality and collaboration.’ Other responses (8) pertained to ensuring the involvement of all stakeholders. Some of these responses included “if stakeholders know that other people are looking at their use of expenses… they will be more likely to respond in an evidence-based manner”. Coordinating the services and ‘identify(ing) the real key stakeholders’ and ‘engaging (them to identify) what they want to know from research evidence… so that work on evidence is driven according to stakeholder priorities’ were identified as ways to improve emergency response and preparedness.When participants in the focus groups were asked how they would improve the engagement of stakeholders in pre- and post- disaster response and planning, they commented that it was critical to strengthen coordination of services between the NGOs, stakeholders, and local authorities, assessing the areas needing improvements, and proper analysis and dissemination of the data presented. One respondent said that “Mapping stakeholders and understanding their area of expertise and capability (and bring) them together on specific areas of concern’ is crucial to making the response and preparedness actions more well-organized and effective. The need to collect and share the data in a manner that is ‘clear and transparent’ was seen as critical, as was educating stakeholders using evidence-based data and information and creating a universal standard for disaster planning and response.Focus group participants were also asked what action they would take to improve pre- and post- disaster and emergency cooperation and coordination in key stakeholders. Their responses focused mainly on the need for communication between NGOs and stakeholders to ‘reduce (the) overlap of responsibilities’ and streamline the process in a more efficient manner. Additionally, the need to identify the proper chain of command of stakeholders is also a priority. ‘There was agreement among respondents about the value of increased accessibility to scientific evidence, improved communication among stakeholders, and engagement of multiple beneficiaries to facilitate the development of evidence-based ‘best practices’ for disaster planning and response. Most believed that policy and decision-makers need to be educated about the research to effectively implement evidence-based policy. Many respondents believed that accessibility to information at all levels can be challenging and that overcoming communication and financial barriers, as well as problems with distribution of information, can improve accessibility of information to ensure evidence-based decision-making. Furthermore, cooperation and coordination among all key stakeholders and beneficiaries was a consistent theme.International and multi-national organizations, as well as national governments and NGOs could strengthen their respective response to disasters by using available evidence, and Cochrane-style systematic reviews should be used to synthesize evidence of disaster response effectiveness. Most believed that, although research-based evidence is preferable, for the most part it is ‘best practice’ information that serves currently as ‘evidence’ on which decision-makers and practitioners create their disaster responses. Most respondents also believe that improvements in co-operation/co-ordination among disaster relief agencies in the collection, analysis and dissemination of data and information regarding disaster response would improve disaster response. Indeed, co-operation and co-ordination among all key stakeholders was a consistent theme through the responses, contributing to improving on social return on investments in disaster response. Respondents believe that, although there are major impediments to effective and equitable disaster response that derive from both the country in which the disaster occurred  and external factors , these impediments can be addressed by practicing evidence-based policy-making and specific disaster-responses.To improve the use of evidence in pre-disaster and post-disaster planning and response, those responsible for disaster response planning and implementation must share information, increase the scientific and evidence-based foundation for disaster response and establish a mechanism to consolidate decision-making. To facilitate the sharing and use of evidence-based information, it should be presented in ‘lay’ language to increase the likelihood of broader use by a wide range of key stakeholders. Additionally, consideration should be given to creating and maintaining a central source of evidence-based policies, practices, and other data and information that can be made accessible to disparate groups through a wide range of mechanisms, including but not limited to the Internet. The use of evidence should become a habit in pre-disaster planning and post-disaster response, with decisions made at the central level being evidence-based. Furthermore, a mechanism for accountability is key to ensuring the scientific and evidence-based foundation. Consolidating decision-making allows information to be spread more rapidly, increasing accountability in evidence-based actions, and provides a focal point of command.To improve the engagement of key stakeholders, pre-disaster and post-disaster planning and response, steps need to be taken to increase transparency, expand needs assessments, and encourage community participation. Transparency on the part of the government, NGOs, and other aid organizations increases access and accountability, making key stakeholders more willing to be engaged in the process. As an aspect of increasing transparency, expanding needs assessments engages stakeholders and improves the likelihood of success through raising knowledge of the actual needs of a community or region. A better understanding of actual needs will offer an opportunity for a more comprehensive and catered plan to the area experiencing a disaster. Furthermore, community participation will not only make those planning and responding to disasters more aware of actual needs, but also will help to ensure that those organizing or directly providing responses are more accessible and transparent to the community. In turn, this encourages active community participation in prevention of and responses to disasters.right stakeholder to be engaged in an aspect of disaster planning and/or response. A set standard or metric for disaster response will mitigate squabbles over jurisdiction and role, increasing synergy and co-ordination. An established standard will make language uniform and accessible, implement a chain-of-command, and measure success.Improving co-operation and co-ordination among key stakeholders in pre-disaster planning and post-disaster response is vital. To do so, steps must be taken to open dialogues among key stakeholders, make funding more fluid and adaptable, and encourage a set standard for disaster planning and response, be it by a hierarchy of command or metrics for accountability. Creating dialogue between and among stakeholders will allow for a better sense of each stakeholder’s strengths and abilities, as well as bring synergy to disaster planning and response. Dialogues can offer a map of stakeholders and their expertise. Flexible and adaptable funding allows for increased co-operation and co-ordination, allowing for the International Standards and guidelines regarding disaster planning and response and related concerns National Laws or Regulations, Guidelines and Practices relevant to disaster planning and response and related concerns National context, including socioeconomic circumstances and relevant policies and systems Evidence-based principles derived from this policy Delphi study: On-going and disaster-specific community engagement; proactive planning; addressing local and international complexities; considering and adhering to ethical and human rights accords, including balancing individual and societal rights; ensuring evidence-based policies and practices; information disseminationSENDAI Framework: understanding disaster risk, strengthening disaster risk governance to manage disaster risk, investing in disaster risk reduction for resilience, enhancing disaster preparedness for effective response and to “build back better” in recovery, rehabilitation and reconstructionFigure The most effective means of facilitating the development and implementation of consistent, coordinated policies and practices within, between and among nation states to take into consideration the overlapping domains might be for the United Nations Office for Disaster Risk Reduction to take the lead in engaging key organizations in the necessary dialogue and collaboration. Relevant organizations would include, for example, related UN agencies, health professional associations, non-governmental and bilateral organizations that provide disaster responses; and national organizations with responsibility for disaster planning and response.The United Nations Office for Disaster Risk Reduction could serve as the Secretariat for compiling and presenting evidence-based practices, as well as for the consideration of policies and practices based on this evidence. The focus should be on managerial, political and social feasibility of implementing the policies and practices, resource requirements  and how to address them, and ethical and human rights implications. The United Nations Office for Disaster Risk Reduction could also provide a focal point for meetings to address evidence-based disaster planning and response.This study yielded three main goals as a means of improving the quality of disaster planning and response: 1) increased accessibility to scientific evidence, 2) improved communication among stakeholders, and 3) engagement of multiple beneficiaries to facilitate the development of evidence-based ‘best practices’ for disaster planning and response. Each of these goals can be implemented in ways that respect local culture and tradition while holding fast to the best tenets of evidence-based scientific practice. The consensus of respondents in this Delphi iterative study was optimistic for better future disaster plans and responses.To improve evaluation of the effectiveness of pre-disaster and post-disaster planning and response, steps must be taken to plan the project with the desired outcome in mind and establish uniform methods of evaluation. Planning the project with the desired outcome in mind allows for a more structured approach with easily recognizable objectives, making the measuring of the success of these objectives much easier. This allows the evaluation to become a part of the planning process itself, ensuring that a proper evaluation is carried out and not merely an afterthought. A uniform method of evaluation will create a standard for the evaluation of disaster planning and response practices and activities, which will improve the ability to gather actual evidence on these practices.Recent humanitarian disasters – due to natural and man-made hazards or a combination of the two – reinforce the need for more effective, efficient, humane responses at the local, national and international levels. This study has yielded findings that can be used to strengthen planning and response – taking into account evidence based on research that has been carried with the engagement of community members and with support by key stakeholders.Additional file 1:Round 1. Questionnaire. (PDF 1403 kb)Additional file 2:Round 2. Questionnaire. (PDF 119 kb)


For the diagnosis of prosthetic joint infection, real evidence-based guidelines to aid clinicians in choosing the most accurate diagnostic strategy are lacking.To address this need, we performed a multidisciplinary systematic review of relevant nuclear medicine, radiological, orthopaedic, infectious, and microbiological literature to define the diagnostic accuracy of each diagnostic technique and to address and provide evidence-based answers on uniform statements for each topic that was found to be important to develop a commonly agreed upon diagnostic flowchart.The approach used to prepare this set of multidisciplinary guidelines was to define statements of interest and follow the procedure indicated by the Oxford Centre for Evidence-based Medicine (OCEBM).The online version of this article (10.1007/s00259-019-4263-9) contains supplementary material, which is available to authorized users. The European Association of Nuclear Medicine (EANM) is a professional nonprofit medical association that facilitates communication worldwide between individuals pursuing clinical and research excellence in nuclear medicine. The EANM was founded in 1985. EANM members are physicians, technologists, and scientists specializing in the research and practice of nuclear medicine.The EANM will periodically define new guidelines for nuclear medicine practice to help advance the science of nuclear medicine and to improve the quality of service to patients throughout the world. Existing practice guidelines will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated.Each practice guideline, representing a policy statement by the EANM, has undergone a thorough consensus process in which it has been subjected to extensive review. The EANM recognizes that the safe and effective use of diagnostic nuclear medicine imaging requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guideline by those entities not providing these services is not authorized.These guidelines are an educational tool designed to assist practitioners in providing appropriate care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, the ESR, EBJIS, ESCMID, and the EANM suggest caution against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into question.The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in light of all the circumstances presented. Thus, there is no implication that an approach differing from the guidelines, standing alone, is below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the guidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of the guidelines.The practice of medicine includes both the art and the science of the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions makes it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to these guidelines will not ensure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient, to deliver effective and safe medical care. The sole purpose of these guidelines is to assist practitioners in achieving this objective.Because of increased life expectancy, the number of joint prosthesis replacements continues to grow at a significant rate, with several millions prosthetic joints implanted each year worldwide . Most ofPJIs are usually classified in relation to the time of onset after surgery: (i) early, within the first 3 months after surgery, (ii) delayed (between 3 months and 2 years after surgery), and (iii) late (more than 2 years after surgery) . MicroorEarly infection is often easy to recognize by acute pain in the wound area, redness, swelling, wound leakage, heat, and fever. Late infection is often caused by haematogenous spread, with symptoms from both the affected joint and the primary infection site. The main diagnostic problem is the delayed, often low-grade infection with mostly nonspecific symptoms. In all PJIs, a delay in starting an appropriate antibiotic regimen and surgical treatment has an important impact on the chance of saving the prosthesis and joint function. Therefore, early diagnosis is of utmost importance.There is no single routine test available that can diagnose PJI with sufficient accuracy. Cultures, biopsies, serum inflammatory markers, and imaging techniques all have their pros and cons. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and leukocyte count are not sensitive or specific enough to detect or exclude a PJI. Joint aspiration itself involves a risk of infection, and its sensitivity is highly variable. In general, a combination of clinical, laboratory, microbiological, and imaging tests are performed based on personal experience, techniques available in the institute, and cost aspects. Indeed, most signs and symptoms that might indicate the presence of a PJI may be simply related to an aseptic loosening of the prosthesis or to a soft tissue infection. Since loosening, soft tissue infection without osteomyelitis, and PJI require different treatment strategies , the correct differential diagnosis among these clinical situations is crucial.Staphylococcus aureus is most commonly isolated in early infection, whereas coagulase-negative staphylococci are more frequent in late infection [The development of biofilms plays a strategic role in the pathogenesis of PJI. Microorganisms adhere to the implant and form a biofilm, within which they are protected from the host immune system and most antibiotics , 8. The Pseudomonas aeruginosa, Enterobacter spp., and Proteus spp., even if relatively uncommon agents, have an important clinical impact because of the difficulty in treating them [Candida spp., Brucella spp., and mycobacteria have also been reported [Other commonly isolated organisms in late infections are streptococci 9–10%), enterococci 3–7%), and anaerobes (2–4%) [%, and an–10%, enting them , 12. Unureported .Pseudomonas aeruginosa, Enterobacter spp., and Proteus spp., even if relatively uncommon agents, have an important clinical impact because of the difficulty in treating them [Candida spp., Brucella spp., and mycobacteria have also been reported [Other commonly isolated organisms in late infections are streptococci 9–10%), enterococci 3–7%), and anaerobes (2–4%) [%, and an–10%, enting them , 12. Unureported .There are several papers available with recommendations for diagnosing PJI, all with limitations: not focusing strictly on PJI, not focused on a diagnostic flow chart, not including nuclear medicine, based only on expert opinion and/or local consensus meetings, or not up to date . Therefore, multidisciplinary evidence-based guidelines are needed, including the most relevant imaging techniques to support the most accurate diagnostic strategy. To achieve this goal, nuclear medicine physicians organized a pre-congress meeting with infectious disease specialists, radiologists, and orthopaedic surgeons on the occasion of the 20th congress of the European Association of Nuclear Medicine (EANM), where each professional discipline explained their points of view, and together they drafted a possible diagnostic flowchart for PJI . As thisAfter several joint symposia and reading of several available guidelines based only on expert opinion, we recognised that a multidisciplinary evidence-based guideline for diagnosing peripheral bone infections was needed. This joint society project started in 2015, and a working group was created with delegates from four European societies: the European Association of Nuclear Medicine (EANM), the European Society of Radiology (ESR), the European Bone and Joint Infection Society (EBJIS), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). The delegates first met in Vienna (November 2015) to define the statements and after that in Rome (February 2016) to jointly define the revised and final statements, based on the literature evidence that had first been circulated among all participants. Finally, all delegates approved the final version of each statement.Uniform statements were addressed for each topic, with the aim of positioning all diagnostic procedures in a commonly agreed upon and evidence-based diagnostic flowchart. Each consensus statement is followed by comments derived from analysis of the relevant literature.An extensive literature search of the PubMed/Medline and Scopus databases was conducted (for the period from 1 January 2000 up to December 2015) for each statement and for overall diagnostic accuracy of each diagnostic technique. Search terms were defined in agreement with all delegates from the four participating societies. Inclusion of the papers per statement was based on a PICO (Population/problem – Intervention/indicator – Comparator – Outcome) question to search for evidence after converting the PICO question into a search strategy. This strategy is described in detail by the Oxford Centre for Evidence-based Medicine (OCEBM) [All included papers per statement were thoroughly read and analysed, and a “level of evidence” was provided in consensus with all delegates for each paper according to the documents for levels of evidence provided by the OCEBM . FinallyThe diagnostic approach in patients with suspected PJI is extremely variable from centre to centre, depending on local experience, technological equipment, and adherence to available guidelines.However, thus far there are no published “evidence-based” guidelines to guide the diagnostic flow of PJI. Clinical examination and laboratory tests, together with a planar x-ray film, are the first steps. These are followed by biopsies, or joint aspiration with microbiological analysis or advanced imaging modalities such as radiological and nuclear medicine examinations. These are explained in more detail in Appendix All PICOs performed for the statements and the list of publications selected for the level of evidence are mentioned in Appendix 1. PJI should be suspected when one or more of the following symptoms and signs are present: otherwise unexplained pain and/or fever, redness, swelling, scar inflammation, and movement limitations. These symptoms are  not specific and require other investigations.Level of evidence: 4.The main clinical signs of early PJI are persistent local pain, erythema, swelling, wound healing disturbance (leakage), and fever. In delayed and chronic infection occurring many years after prosthesis insertion, clinical signs may be absent; when present, they are represented by persistent or increasing joint pain and a loose prosthesis.Symptoms are not specific for infection, and it is not easy to distinguish PJI from aseptic loosening by clinical history and physical examination alone. As a consequence, patients with one or more of the above-mentioned signs and symptoms should undergo further investigation for diagnosing or excluding the presence of infection –54.2. Sinus tract and purulent discharge are clear signs of prosthetic joint infection.Level of evidence: 5.There are no papers published on this specific issue; rather, this is a general belief based on the logical assumption that, given the natural colonization of the skin, these bacteria will certainly colonize the exposed implant. However, no literature was found providing evidence that a sinus tract with purulent discharge is a sign of PJI. There is no evidence that microbiological analysis of tissue or fluid from sinus tracts is reliable for diagnosis.3. CRP and ESR should always be performed in patients with suspected prosthetic joint infection. A normal value does not rule out PJI.Level of evidence: 2.Patients presenting with clinical signs of prosthetic joint infection  should be subjected to screening for inflammatory markers in serum. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) are good preliminary tests. Screening of these markers can be performed rapidly, inexpensively, and with minimal inconvenience. Although there is considerable variation in sensitivity (SE) and specificity (SP) for both CRP  and ESR , in general they show good diagnostic value, and are of relevance particularly for therapy follow-up. A threshold of 10 mg/l for CRP and 30 mm/h for ESR of is recommended for diagnostic purposes. One level 1 study and 32 level 2 studies addressed the diagnostic efficacy of CRP and ESR in serum , 55–82. 4. In the case of fever, blood cultures should always be performed in patients suspected of having prosthetic joint infection in order to identify the causative bacteria.Level of evidence: 5.Microorganisms may reach the prosthesis at the time of implantation or later by haematogenous spread , 7.S. aureus can also occur in patients without a detectable primary focus [Haematogenous seeding can occur at any time after joint implantation. The main sources of bacteraemia are skin, respiratory tract, dental procedures, and urinary tract infection . Haematory focus .No studies specifically assessed the role of blood cultures in diagnosing PJI. However, in consideration of the frequent haematogenous origin of PJI, it is recommended that blood cultures be performed in patients with suspected PJI who have fever.5. Conventional radiography is the first imaging modality to perform in patients with suspicion of PJI for diagnosis and follow-up.Level of evidence: 2.Conventional radiography is regularly used to evaluate joint prostheses after implantation and follow-up, as these procedures are able to detect any potential abnormality involving both the implant and the surrounding bone. For this reason, conventional radiography should always be performed. Regarding PJI, conventional radiography often yields normal results or may detect nonspecific signs of soft tissue swelling. Serial plain radiography has been reported to have sensitivity of 14% and specificity of 70% in detecting implant-associated infections. Radiographic signs that may reveal PJI with high specificity are gas formation and active, immature periostitis. Radiographic signs with low specificity include soft tissue swelling, periprosthetic lucency, and component loosening. However, differentiation between septic and aseptic periprosthetic lucency and component loosening is almost impossible on conventional radiography. Also, these signs are visible only when almost 30% of the bone mass has been lost; thus, 50% of radiographs remain normal despite the presence of infection –87.6. Ultrasound can detect complications around the prosthesis, but the capacity for detecting infection is controversial.Level of evidence: 2.Van Holsbeeck et al. reported 100% sensitivity and 74% specificity for infection when the a capsule-to-bone distance was >4 mm, while 100% specificity was observed when the capsule-to-bone distance was >3.2 mm and extracapsular fluid was found in the hip . These f7. Imaging may be useful for guiding joint aspiration or periprosthetic tissue biopsy.Level of evidence: 2.One of the challenges of correct aspiration or biopsy in and around the implant is placing the needle exactly in the area of interest. Open aspiration and biopsy can be done in a surgical theatre, but this approach is highly invasive. Fluoroscopy can be used as a guide, but it does not correctly show soft tissues and fluids, and it uses ionizing radiation. US can be used to guide the needle in the joint space and in the soft tissue around the implant without the use of ionizing radiation. Eisler et al. reported 7% sensitivity and 66% specificity for ultrasound-guided capsular biopsy, while fluid aspiration was always falsely sterile . Battagl8. Leukocyte count and differential in synovial fluid has high diagnostic accuracy in detecting PJI.Level of evidence: 2.Patients with abnormal CRP and/or ESR should undergo aspiration of the hip or knee. We recommend that aspiration fluid be tested for white blood cell count (WBC) and percentage of neutrophils. Our systematic review of the literature showed high sensitivity and specificity for both tests. Synovial white blood cell count had sensitivity of 36–100% and specificity of 80–99%. Differential count had sensitivity of 84–100% and specificity of 80–99%. A threshold for white blood cell count of >3000 cells/μl seems justified based on the studies found (the thresholds from various reports vary from 1700 cells/μl to 5000 cells/μl). Neutrophil percentage > 70% is highly suggestive of prosthetic joint infection (range 65–80%). Fourteen level 2 studies addressed the diagnostic efficacy of synovial fluid white blood cell count and differential , 94. Asp9. Bacterial culture from joint aspiration has high diagnostic accuracy in detecting prosthetic joint infection.Level of evidence: 2.Given the limitations of the preoperative diagnostic work-up in identifying the presence or absence of infection, fluid and tissue cultures of the suspected infection site are often necessary. Twenty-three level 2 studies in our systematic review showed moderate to high sensitivity (43.5–100%) and high specificity (81.2–100%) for cultures , 95–108.10. Measurement of the synovial biomarkers alpha-defensin, leukocyte esterase, interleukin-6, and C-reactive protein is useful in the detection of prosthetic joint infection.Level of evidence: 2.Cutibacterium acnes (formerly Propionibacterium acnes) are less likely to be demonstrated with alpha-defensin measurement. Another synovial biomarker, leukocyte esterase, has also demonstrated diagnostic value, with sensitivity of 66–100% and specificity of 77–100% in five level 2 studies [In the last decade, numerous studies have addressed the evaluation of new biomarkers in synovial fluid. These biomarkers show promising results. In our systematic review, alpha-defensin showed very high sensitivity and specificity  in three level 2 studies and two level 3 studies , 109–111 studies –116. Leu studies , 118. IL studies . Routine11. Biopsy of periprosthetic tissue for histology and cultures can be performed for preoperative diagnosis in cases where ESR and/or CRP are positive and aspiration is inconclusive or impossible to test (dry tap).Level of evidence: 2.Biopsy is not advised in all cases, as it is an invasive diagnostic modality. Five papers showed high diagnostic value ; therefore, biopsy can be used to rule in and rule out infection , 122. Kn12. Antibiotic therapy should be postponed or discontinued before pre- and intraoperative sampling.Level of evidence: 4.In clinical practice, the dictum that antibiotics should be withheld before obtaining microbiological cultures is well recognised. Some studies have confirmed the impact of previous antibiotic therapy on the probability of obtaining a microbiological diagnosis of PJI.In a prospective trial in 79 patients with PJI, culture of samples obtained by sonication of the explanted prostheses were compared with conventional culture of periprosthetic tissue for the microbiological diagnosis of prosthetic joint infection. The sensitivity of the tissue cultures decreased (from 77% to 48% to 41%) as the antimicrobial-free interval before surgery decreased  . This waAnother study found a statistically significant difference in the rate of positivity of biopsy specimen bacterial cultures between patients exposed and not exposed to previous antibiotic therapy .Similarly, some studies reported higher sensitivity of synovial fluid culture in patients who did not take antibiotics before the procedure as compared with patients exposed to antibiotics , 124.13. Antibiotic therapy should not be discontinued before white blood cell scintigraphy.Level of evidence: 4.The issue of whether on-going antibiotic treatment may interfere with the diagnostic accuracy of WBC scintigraphy has been widely disputed, yet there are no clinical comparative studies in patients with and without antibiotic treatment. Therefore, this information can only be extrapolated indirectly from studies that have included patients at diagnosis treated with antibiotics or from studies in patients during follow-up of therapy. Indeed, there are a number of studies of this kind in osteomyelitis  –131, sofIn summary, there is not sufficient evidence in the literature to reach a definitive conclusion on the impact of antibiotic treatment on the accuracy of WBC scintigraphy in PJI.14. Computed tomography can be effectively used to diagnose PJI.Level of evidence: 2.Computed tomography has traditionally been used to evaluate orthopaedic implants. Striking artefacts caused by the interaction of the x-ray beam with the metallic hardware are now markedly reduced thanks to recent technical improvements. On CT, joint distension, fluid-filled bursae, and soft tissue collections are the main findings. Cyteval et al. reported that CT demonstrated 100% sensitivity, 87% specificity, and 89% accuracy when at least one soft tissue abnormality was used as an infection criterion, and 83% sensitivity, 96% specificity, and 94% accuracy when joint distention was used as infection criterion . Absence15. The diagnostic accuracy for three-phase bone scintigraphy in patients with suspected infection within the first 2 years after hip or knee prosthesis placement is low.Level of evidence: 2.Three-phase bone scintigraphy is the most widely used screening modality for the diagnosis of PJI. However, it is common knowledge that the technique is highly sensitive but has low specificity for PJI, since any cause of increased bone formation  shows increased periprosthetic activity on the bone scan. This physiological bone remodelling probably takes place in the first years after joint replacement surgery and is also dependent on the type of prosthesis and whether the prosthesis was cemented or uncemented.The results of our search yielded 89 papers, of which 14 were included. After reading these papers thoroughly, we included only five papers that investigated the role of three phases in bone scan after joint replacement –148, fouExperts agree that the diagnostic accuracy for three-phase bone scan in patients with suspected infections within the 5 years after hip or knee prosthesis placement is low. Van der Bruggen et al.  mention 16. In the case of negative three-phase bone scintigraphy, a diagnosis of prosthetic joint infection can be excluded.Level of evidence: 2.Bone scintigraphy is widely used as first imaging modality when there is suspicion of a low-grade PJI. All three phases  are necessary when an infection is suspected. Although a positive bone scan can be the result of any cause of increased osteoblast activity, a negative bone scan in all three phases means that there is no increased perfusion and no increased osteoblastic activity. It has been stated, therefore, that a negative three-phase bone scan rules out a diagnosis of PJI.We conducted a literature search and 76 papers were retrieved, of which 15 were eventually included for thorough reading.Only four research studies focused on the negative predictive value of the three-phase bone scan. Ikeuchi et al.  investigOther included papers  are in agreement that a study with normal findings  can be considered strong evidence against the presence of an infection , 153–15617. In the case of a positive three-phase bone scan, the addition of white blood cell scintigraphy leads to high diagnostic accuracy for PJI.Level of evidence: 2.A positive three-phase bone scintigraphy can have several causes, including PJI, physiological bone remodelling, or aseptic loosening of the prosthesis. Therefore, other investigations must be performed to further differentiate between infection, reactive changes, and loosening. To determine whether WBC scintigraphy, when added to the diagnostic flowchart of a positive three-phase bone scintigraphy, leads to higher diagnostic accuracy, we conducted a PubMed search with the following terms: “(prosthetic OR prosthesis OR joint infection)) AND (bone scan OR MDP OR HDP OR bone scintigraphy)) AND (WBC scan OR WBC scintigraphy OR white blood cell scan OR white blood cell scintigraphy OR leukocyte scintigraphy)) AND diagnosis of infection”; 44 papers were retrieved, of which 19 were eventually included for thorough reading.Only two research papers were found that specifically studied whether the addition of WBC scintigraphy after a positive bone scan leads to high diagnostic accuracy. Volpe et al.  showed tWe also agree that another imaging modality is necessary in the case of a positive three-phase bone scan in patients with suspected PJI , 157–16018. In the case of negative white blood cell scintigraphy, the probability of prosthetic joint infection is low.Level of evidence: 2.WBC scintigraphy has been described by many authors as highly sensitive and very specific for the diagnosis of PJI. However, there is still some concern whether low-grade chronic PJI with small amounts of bacteria on the biofilm can lead to false-negative WBC scan results.We conducted a literature search to look at the diagnostic accuracy of WBC scintigraphy in patients with suspected PJI, and we retrieved 97 papers, of which 20 were eventually included for thorough reading and 12 after thorough reading.111In or anti-granulocyte imaging, or a combination of WBC/bone marrow (BM) scintigraphy.The largest patient series included is from Kim et al. , who fou99mTc- and 111In-labelled WBC, and found 94% true-negative results [Sousa et al.  report N results . Only Ba results . In conc19.18F-FDG-PET in patients with suspected prosthetic joint infection has high sensitivity but lower specificity than white blood cell scintigraphy or anti-granulocyte antibody scintigraphy.Level of evidence: 2.A PubMed search based on the above-listed MeSH terms revealed 15 papers, of which five  were selected for thorough reading. In addition, four papers on the diagnostic performance of WBC scintigraphy in prosthetic joint infections were added.99mTc-sulfur colloid- and 111In-labelled WBC demonstrated sensitivity of 50% and specificity of 95%.There are few articles directly comparing the diagnostic performance of FDG-PET and WBC scintigraphy. The study by Love et al.  reportedReinartz et al. , in a syIn all mentioned systematic reviews, the range for both sensitivity (28–91%) and specificity (34–97%) in the individual studies was quite large. This is largely attributable to the differences in study design and interpretation criteria , emphasizing the need for standardized reconstruction and interpretation criteria.Although there are not many published papers that directly compare FDG-PET and WBC scintigraphy in prosthetic joint infections, several different interpretation criteria for FDG-PET have been tested, and all papers confirm the lower specificity of FDG-PET compared with WBC scintigraphy. Large prospective studies comparing the diagnostic performance of WBC scintigraphy and FDG-PET for prosthetic joint infections are anticipated.20. Anti-granulocyte scintigraphy is a good alternative to white blood cell scintigraphy, with similar sensitivity and specificity .Level of evidence: 2.99mTc-besilesomab- and 99mTc-labelled white blood cells in peripheral osteomyelitis, including patients with PJI, was published by Richter et al. [An extensive PICO was performed using a combination of different terms, but no papers were found that directly compared the diagnostic accuracy of labelled white blood cells with anti-granulocyte antibodies for patients with suspicion of prosthetic joint infections. A direct comparison between r et al. , with cor et al. , 170.Two meta-analyses on the diagnostic performance of anti-granulocyte antibodies in prosthetic joint infections were performed by Pakos et al.  and Xing21. Hybrid SPECT/CT imaging can improve localization of infection (and diagnostic accuracy).Level of evidence: 2.Since the introduction of hybrid imaging technologies in clinical practice, the diagnostic accuracy of conventional nuclear exams has drastically improved due to the complementary molecular/functional and morphological information. Even though current recommendations for interpreting white blood cell scintigraphy are based solely on planar images at consecutive time points, adding SPECT/CT in the case of a positive result would theoretically further increase the diagnostic accuracy. It is well established for other pathologies that adding SPECT/CT to planar images results in higher diagnostic accuracy because of better resolution and morphological information.A PubMed search yielded 50 papers, of which five papers , there is active WBC accumulation, which is interpreted as an infection. By contrast, if the ratio decreases over time (i.e. T/B20h < T/B4h), there is only transient WBC accumulation in the lesion, and it is interpreted as a sterile inflammatory process. Only two works have systematically investigated these assumptions, however, in retrospective studies, using the histological/microbiological information or long-term clinical follow-up of patients as gold standard [Based on the assumption that radiolabelled WBC, once injected into the patient, will migrate over time to an infected area and will progressively accumulate there due to the presence of chemotactic factors, nuclear medicine physicians have thought to quantify the presence of WBC in suspected lesions at 3–4 h after injection and again at 20–24 h. This quantitation is expressed as a ratio between radioactivity in the suspected region (target) and radioactivity in a background area. If this target-to-background (T/B) ratio increases over time  and bone marrow scintigraphy (with radiolabelled colloids) has been studied by many authors. This technique allows us to reduce the number of false-positive cases at WBC scintigraphy due to WBC accumulation in areas of expanded/displaced bone marrow by providing a map of bone marrow activity. It is particularly useful in cases of suspected PJI and in patients with a doubtful qualitative or semiquantitative analysis of WBC scintigraphy.The use of combined WBC scintigraphy  have made MRI wholly feasible in patients with joint implants, with artefacts largely confined to the area of the implant itself –187. The25. MRI demonstrates high diagnostic performance in detecting clinically suspected PJI, with no ionizing radiation.Level of evidence: 2.Despite the widespread use of this protocol in clinical practice, most papers on MRI and joint prosthesis were focused on the technical feasibility of this examination. Only three papers specifically aimed to evaluate prosthesis infection. In the knee, Plodowski et al. found 86–92% sensitivity and 85–87% specificity for infection, while Li et al. found 65–78% sensitivity and 98–99% specificity. In the hip, He et al. found 94% sensitivity and 97% specificity. Like ultrasound, MRI is an imaging modality that does not use ionizing radiation. This fact should be given particular consideration, especially in these patients, who typically need repeated examinations –47.The proposed flowchart is shown in Fig. Based on the above-mentioned statements and evidence from the published literature, we have developed a diagnostic flow chart, shown in Fig. In some cases, the flow was integrated by consensus opinion amongst the experts, since not all steps are always clearly deducible from the literature or from level 1–2 articles. The flow chart does not take into consideration socioeconomic factors or the availability of diagnostic methods. It also presumes that all exams are optimally performed  and by expert professionals.ESM 1(DOCX 23 kb)ESM 2(DOCX 67 kb)ESM 3(DOCX 44 kb)