A framework for the development and implementation of open trauma guidelines: A Delphi consensus validation

A framework for the development and implementation of open trauma guidelines: A Delphi consensus validation | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A framework for the development and implementation of open trauma guidelines: A Delphi consensus validation Juan Enrique Berner, Carl Heneghan, Jagdeep Nanchahal, Abhilash Jain This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6378469/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction: Lower limb open fractures are severe injuries that can lead to long-term sequalae. Clinical guidelines for managing these patients are associated with expedited treatment and better outcomes. However, few countries have implemented guidelines for open lower limb fractures. The aim of this study was to develop and validate a framework for the introduction of clinical guidelines in settings that do not have one at present. Methods: Using the qualitative analysis for the Limitations to the Implementation of Open Trauma Guidelines (LINEAGE) study, a framework proposal was designed. This included 4 clusters of inter-related concepts, including clinician, team, health and cultural factors. To validate this framework a modified Delphi study was devised. The elements of the framework were translated into 12 statements that were compiled in a Delphi questionnaire. A panel of orthopaedic and plastic surgeons was assembled to obtain structured feedback and assess the degree of consensus regarding the framework proposal. Results: Using purposive sampling, 43 clinicians enrolled in an international expert panel, including 20 orthopaedic and 23 plastic surgeons based in countries with no guidelines at present. Following three Delphi rounds, 11 out of the 12 assessed statements achieved the threshold for validation. The single statement that did not reach consensus status was then removed from the framework. Discussion: Frameworks are a well described aid in implementation science, being able to describe complexity and propose strategies for improvement. We present the first validated framework for the development and implementation of open fracture guidelines. open fractures framework implementation science Delphi study Figures Figure 1 Figure 2 Introduction Open fractures affecting the lower extremities are severe injuries with potential long-term physical, quality of life, and financial repercussions 1 . The management of patients suffering from these involves interventions that address both the skeletal and soft tissue components, with the aim of achieving bony stabilisation, adequate cover and avoidance of infective complications. In the United Kingdom, clinical guidelines have been introduced to standardise the treatment of open lower limb fractures, advocating for a multidisciplinary approach to these injuries in centres where specialist care can be provided 2 , 3 . Although there is evidence that being treated in a setting with clinical guidelines for open lower limb fractures is associated with expedited treatment and better outcomes 4 , we have found that very few countries have developed such documents to date 5 . Despites their potential benefits clinical guidelines remain an exception rather than the norm at an international level. The recently published LINEAGE study described the multiple challenges involved in developing and implementing guidelines in settings that do not have one at present 6 . Considering the potential benefits of clinical guidelines in managing open fractures, we aimed to develop a framework to aid optimising the uptake of evidence, in the form of clinical guidelines, for managing these injuries. The article summarises the process that led to the development of this framework along and a Delphi study used to achieve its validation. Methods Development of framework proposal Implementation science is the rigorous study of methods to achieve the systematic adoption of evidence into policy and routine practice 7 . This discipline recognises the importance of establishing a theoretical basis for implementing change and the importance of qualitative research in the development of frameworks 8 . These provide a structured graphical or narrative representation of a system, presenting the concepts or variables that interact with each other in relation to the phenomenon of interest 9 . The development of frameworks in implementation science is the result of a process of qualitative theorisation, in which ontological and epistemological assumptions are made. Each concept is created, acquiring meaning on its own as an observation is synthesised, remaining different from other concepts while relating to them 10 . A framework is not merely a collection of these concepts or ideas, but rather a construct that aims to interpret a reality. They do not necessarily provide a causal or deterministic explanation but rather provide an understanding of a phenomenon 11 . The LINEAGE study analysis provided the necessary building blocks to proceed with the conceptualisation of a framework for the development and implementation of guidelines for open lower limb injuries. The aim was to present current challenges, while proposing a strategy to assist in the uptake of evidence to improve the care for patients with such injuries (Fig. 1 ) At the centre of the proposed framework, a single concept is presented, epitomising the main goal for this framework: effective guideline implementation . Around this principal concept, four clusters of ideas are presented, each one playing a role in succeeding to achieve the aim at its centre. Above the central aim of this framework, the first concept encountered is clinician . This item acknowledges their role in the decision-making that defines the treatment for patients with open fractures. As previously discussed, guidelines have the potential to modify clinicians’ behaviour by offering evidence-based recommendations . However, LINEAGE highlighted the importance of auditing practice to avoid the unfortunate situation of having a robustly developed guideline that is not followed. Awareness of the quality of care delivered allows not only to measure adherence to recommendations, but it also provides feedback for future improvement. Towards the right side of the diagram, a second cluster is presented in shades of green, focusing on the importance of multidisciplinary collaboration and team dynamics. Lack of clear pathways for collaboration was highlighted in LINEAGE as a problem for delivering timely and coordinated care for patients with open fractures. Implementing a guideline can address this, by establishing who, when and how different specialties should intervene. However, LINEAGE also highlighted how positive interpersonal relationships can be beneficial in delivering patient care. Instead of assuming that guidelines will replace natural human interaction, the framework proposal acknowledges the importance of team building to achieve its goal. Finally, this cluster includes the concept of leadership , as a catalyst in this process. At the bottom of the diagram, I decided to include a third cluster, also associated with a theme previously discussed in the LINEAGE analysis: the immobile systemic factors directly limit the effective implementation of guidelines. This aspect of the framework intends to provide a realistic approach to achieving its goal. Prioritising achievable goals refers to the fact that not all evidence-based recommendations may be feasible to implement in settings where the minimal systemic conditions have not yet been met. This should be aligned with managing expectations , to avoid unrealistic assumptions and the frustration that would be associated with failing to deliver an “ideal” package of care. However, awareness of the role that systemic limitations play in treating patients open fractures would also enable clinicians in their advocacy role in system improvement with the relevant stakeholders. Finally, and placed at the left of the central aim of this framework, I included a series of concepts which have been recognised in the literature as key elements in the process of introducing novel guidelines. These are not necessarily related to the healthcare system factors discussed previously, but rather the cross-cultural differences that require attention in implementing evidence-based recommendations. Local culture should always be considered, as patient and clinician attitude towards the same recommendation may vary in different settings. Language considerations are especially important if a foreign guideline is adopted, even more so if a translation is required. Delphi validation A modified Delphi study was designed to validate the framework presented above. The protocol for this project was shared with the University of Oxford CUREC for evaluation. This was reviewed by the Medical Sciences Division Ethics Committee, and on the 13th of September 2024 we received confirmation that no further ethical considerations were required. Eligible participants for this study were fully qualified orthopaedic, plastic or general surgeon with a clinical interest in open fractures. Utilising a purposive sampling strategy, all senior INTELLECT investigators based in countries with no current guidelines were contacted. An invitation was also circulated in ICOPLAST and International Microsurgery Club channels, allowing for snowballing recruitment to take place. The JISC Online Survey platform (JISC, UK) was used to design a virtual registration form to gather updated contact details and eligibility information from prospective respondents. The first round of this modified Delphi study consisted in the development of a series of statements that summarised each of the concepts included in the previously presented framework proposal. These were phrased in a way to allow respondents to express their level of agreement using Likert-style answers in subsequent rounds. These were compiled in a virtual survey that allowed participants to record their degree of agreement or disagreement for each statement individually. Five statements regarding the framework proposal in general, its clarity and applicability. (Appendix 1). For the second round of this Delphi study, participants were sent a unique link to the finalised questionnaire, with a deadline of two weeks to respond. The results were exported into a password-protected Excel spreadsheet stored on the University of Oxford OneDrive. Descriptive statistical analysis was performed using SPSS software to portray the participating sample of experts using the information obtained. Frequencies and proportions were calculated for each Likert-style question, along with their corresponding mean value and IQR. In order to determine the need of subsequent Delphi rounds, three criteria were had to be met to achieve a consensus. Statements that exceeded an agreement threshold of 80%, with an associated IQR of 1 or less and a mean Likert response of 4.5, were automatically considered validated, with no further testing required. Statements that did not initially meet these three criteria, would qualify for a third Delphi round, allowing for the assessment of response stability. In this further questionnaire, participants were presented with any statement that had not yet achieved validation, along with the previous round response percentages and means. Statement that maintained agreement levels above 80% and IQR of 1 or less in the third round were also considered validated. Any statements that did not accomplish this would procced to be discarded from the framework proposal (Fig. 2 ). Results Validation of individual concepts The participant recruitment phase for this Delphi study ran from the 25th of September until the 2nd of October 2024. During this period a total of 53 plastic, orthopaedic and general surgeons expressed their intention to participate. All 53 complied with the pre-defined inclusion and exclusion criteria. As previously mentioned, the first Delphi round did not involve expert participation. The second Delphi round took place from the 2nd to the 16th of October 2024. Of the 53 invited participants, 43 completed their enrolment by providing consent and fully answering the questionnaire. Twenty (47%) of the respondents identified themselves as orthopaedic surgeons, 23 (53%) as plastic and reconstructive surgeons, with 14 (33%) of participants being female. The median reported time in practice after specialist certification was 9 years Enrolled participants were based in 15 different countries, including the United States (n = 7), Canada (n = 2), Spain (n = 9), Italy (n = 3), Germany (n = 1), Poland (n = 1), Sweden (n = 1), Israel (n = 2), Syria (n = 1), Pakistan (n = 1), Taiwan (n = 2), Kenya (n = 2), Chile (n = 9), Trinidad and Tobago (n = 1), and Australia (n = 1). All statements received a positive response overall (Table 1 ). Eight of these achieved the pre-defined threshold for validation at this stage, including all statements related to clinician factors and team factors. Additionally, the health system statement regarding the role of advocacy also met this threshold. Although the remaining statements presented agreement levels above 80%, their obtained mean response was below 4.5. As per our protocol, this latter group required further testing in a subsequent Delphi round that followed. Table 1 Second round Delphi results. Validated statements highlighted in green 1 2 3 4 5 Mean IQR Clinician factors 1. Recommendations should be based in best available evidence to positively influence clinician decision-making. 0% 0% 0% 19% 81% 4.8 0 2. Continuous audit of care and outcomes should be encouraged as part of implementation. 0% 0% 2% 19% 79% 4.8 0 3. Feedback from audits should be used to measure guideline compliance, as a driver for continuous quality improvement. 0% 0% 5% 19% 77% 4.7 0.2 Team factors 4. Open fractures should be managed within multidisciplinary teams able to provide complex interventions, addressing bone and soft tissues. 2% 0% 2% 21% 74% 4.7 0.8 5. Clear pathways for collaboration across specialties are desirable to optimise patient care, while reducing variability. 0% 0% 2% 28% 70% 4.7 1 6. The positive effect of good interpersonal relationships among clinicians favouring teamwork and inter-specialty collaboration should be recognised. 0% 0% 2% 40% 58% 4.6 1 7. Positive leadership is necessary to facilitate collaboration among a multi-disciplinary team. 0% 0% 0% 35% 65% 4.7 1 Health system factors 8. Open fracture management is inevitably influenced by health system factors that clinicians cannot easily change. 0% 7% 7% 51% 35% 4.1 1 9. Health system factors should be considered when developing an open fracture guideline, so that any recommendation is feasible in real-world scenarios. 0% 0% 9% 42% 49% 4.4 1 10. Expectations should be managed when implementing an open fracture guideline, especially when foreign guideline adaptation is being considered. 0% 2% 12% 53% 33% 4.2 1 11. Although gold-standard care may not always be feasible, awareness of ideal best practice is important, so that effective advocacy is possible. 0% 0% 2% 23% 74% 4.7 0.8 Socio-cultural factors 12. Appreciating cultural and language factors is crucial in the development of guidelines for open fracture management. This is especially relevant when an adaptation is considered. 2% 5% 12% 33% 49% 4.2 1 1: strongly disagree / 2: disagree / 3: undecided / 4: agree / 5: strongly agree On the 24th of October 2024 participants were contacted again via email and presented with the results of the previous questionnaire. For this third Delphi round, a shorter version of the questionnaire was used, focusing on the statements that had not achieved validation previously. Statements regarding overall framework validation were kept, to assess response stability. As previously, participants were given two weeks to respond. A total of 37 participants completed this subsequent questionnaire. The results showed strong and persistent validation of three of the four statements assessed (Table 2 ). Statement number eight, which referred to the fact that open fracture management is inevitably influenced by health system factors, did not achieve the threshold for validation and was discarded from the framework proposal. Table 2 Third round Delphi results. Validated statements highlighted in green. 1 2 3 4 5 Mean IQR 8. Open fracture management is inevitably influenced by health system factors that clinicians cannot easily change. 3% 11% 8% 65% 14% 3.8 0 9. Health system factors should be considered when developing an open fracture guideline, so that any recommendation is feasible in real-world scenarios. 0% 0% 0% 35% 65% 4.6 1 10. Expectations should be managed when implementing an open fracture guideline, especially when foreign guideline adaptation is being considered. 0% 0% 3% 70% 27% 4.2 1 12. Although gold-standard care may not always be feasible, awareness of ideal best practice is important, so that effective advocacy is possible. 0% 8% 0% 43% 49% 4.3 1 1: strongly disagree / 2: disagree / 3: undecided / 4: agree / 5: strongly agree General framework validation Participants were presented with statements that assessed comprehensiveness, conceptualisation, ease of understanding, logic, practicality, and applicability to assess general framework validation. These statements were measured twice, in the second and third Delphi rounds to capture the overall impression of the experts regarding the framework proposal. On both occasions, a positive response was recorded for all these global validation statements. As expected, as the Delphi progressed there was a tendency towards moderation and fewer outliers, while maintaining levels of agreement above 80% (Table 3) Discussion This article introduces a framework to aid in the development and implementation of clinical practice guidelines for lower limb open fractures, with the aim of optimising the uptake of evidence to improve the management and outcomes for these patients. The Delphi study summarised in this manuscript was able to achieve a consensus on the majority of elements included in this framework. All but one of the statements included in the Delphi questionnaire were successfully validated. Furthermore, participants consistently responded positively to the framework as a whole, in terms of comprehensiveness, logic and applicability. Although Delphi methodology offers a pragmatical strategy for seeking consensus among experts, there are limitations to this approach. For this study we defined that any orthopaedic or plastic surgeon with an interest in open lower extremity fractures would qualify as an expert. We considered that this would be a reasonable assumption, having in mind that clinicians with undergraduate and postgraduate training are experts in their field 12 . Furthermore, we specifically aimed for this group as they are in the best position to provide peer-validation as potential early adopters of this framework. However, this study did not include feedback from other stakeholders, such as patient representatives, managers and policymakers. Further research including these groups would provide valuable insight to improve and further validate the framework presented in this chapter. We took a pragmatical approach in terms of the participant selection, reaching out to previous collaborators and their adjacent networks. Although this strategy was successful in terms of recruitment and engagement, it is important recognise that it may have introduced selection bias. In other words, clinicians who have previously participated in open fracture research may have a positive attitude towards the uptake of evidence in open lower limb trauma care. We tried to address this by introducing heterogeneity in respondents by allowing for snowballing effect, resulting in the recruitment of clinicians with whom we had no previous contact. Unfortunately there is no consensus regarding an ideal strategy for recruitment in Delphi methodology 13 . Similarly, there is no available guidance concerning the ideal size of a panel of experts for this kind of studies, and there is no evidence to suggest that a larger sample would be beneficial to achieve the research aims 14 . While the results of this Delphi study validated most of the elements of the framework proposal, it also allowed the identification of areas that needed addressing. On concrete example is the single statement that did not achieve the threshold for validation. This referred to the observation that open fractures are inevitably influenced by health system factors that clinicians cannot easily change. Although the majority of respondents agreed to an extent with this, it is challenging to identify what was the primary source for disagreement. Considering that the remaining health system factors statements were validated, we hypothesise that the source of the dispute was not the assertion that health systems play a role, but the fact that clinicians cannot easily change them. This may reflect that some respondents may have a more positive attitude than us regarding the capacity that clinicians have for changing the systems in which they work. Due to the fact that this item was not validated in the Delphi study, we decided to remove this slightly contentious statement from the final framework proposal (Table 4 ). Table 5.3 Overall framework validation results. Overall framework validation 1 2 3 4 5 Mean IQR This framework provides a comprehensive overview of the key elements that should be considered in the process of developing and implementing guidelines for open lower limb fractures. Delphi round 2: 0% 0% 12% 44% 44% 4.3 1 Delphi round 3: 0% 0% 0% 49% 51% 4.5 1 This framework conceptualises the process of guideline development and implementation, so that it can be applied in settings where no guidelines exist at present. Delphi round 2: 0% 0% 7% 53% 40% 4.3 1 Delphi round 3: 0% 0% 5% 59% 36% 4.3 1 It is easy to understand the concepts included in this framework, along with their relevance in the process of guideline development and implementation. Delphi round 2: 0% 7% 12% 49% 33% 4.1 1 Delphi round 3: 0% 0% 3% 70% 27% 4.2 1 The relationships between the concepts included in this framework are logical and practical. Delphi round 2: 0% 2% 12% 46% 40% 4.2 1 Delphi round 3: 0% 3% 5% 68% 24% 4.3 0.5 This framework has the potential of being a useful resource in the development and implementation of open fracture guidelines. Delphi round 2: 0% 2% 14% 44% 40% 4.2 1 Delphi round 3: 0% 0% 3% 62% 35% 4.3 1 1: strongly disagree / 2: disagree / 3: undecided / 4: agree / 5: strongly agree Table 4 Validated framework proposal Clinician factors 1. Recommendations should be based in best available evidence to positively influence clinician decision-making. 2. Continuous audit of care and outcomes should be encouraged as part of implementation. 3. Feedback from audits should be used to measure guideline compliance, as a driver for continuous quality improvement. Team factors 4. Open fractures should be managed within multidisciplinary teams able to provide complex interventions, addressing bone and soft tissues. 5. Clear pathways for collaboration across specialties are desirable to optimise patient care, while reducing variability. 6. The positive effect of good interpersonal relationships among clinicians favouring teamwork and inter-specialty collaboration should be recognised. 7. Positive leadership is necessary to facilitate collaboration among a multi-disciplinary team. Health system factors 8. Health system factors should be considered when developing an open fracture guideline, so that any recommendation is feasible in real-world scenarios. 9. Expectations should be managed when implementing an open fracture guideline, especially if foreign guideline adaptation is being considered. 10. Although gold-standard care may not always be feasible, awareness of ideal best practice is important, enabling effective advocacy. Socio-cultural factors 11. Appreciating cultural and language factors is crucial in the development of guidelines for open fracture management. Despite the outcome of the Delphi study included in this chapter, we understand that this framework may require further testing and refinement before and after it is put in practice. Future studies focusing on its application in a real-world scenario would provide further insight regarding its applicability and efficacy. To our knowledge this is the first framework described to aid in improving the management of open fractures. We look forward to its dissemination and discussion to continue refining this proposal. Declarations Author Contribution J.E.B participated in the design of the study, gathered data, analysed the data, interpreted the data, prepared figures and tables and wrote manuscript. C.H participated in the design of the study, provided methodological support, assisted in the interpretation of the findings and reviewed the manuscript. J.N. and A.J provided methodological support, assisted in the interpretation of the findings and reviewed the manuscript Acknowledgements We would like to thank the panel of experts that participated in this study, who are named below. As per our study protocol not all of them opted for being named in this manuscript. Participating panel of experts: Alina Ortega-Briones, Ata Ul Haq, Álvaro Zamorano, Beatríz Olías López, Carlos Fonfach, Chad Chang, Carlos Prada, Diana Crego-Vita, Ernesto Ewertz, Anton Fries, Gonzalo Aranda, Yung-Chen Chiu, Oriana Haran, Hari Castro, Héctor Aguado, Javier Martínez Ros, Juan de Dios Errázuriz, Joaquín Palma, Leonardo Parada, Lily Mundy, Antonella López, Luigi Troisi, Macarena Vizcay, Mania Mani, Roberto Martínez, Fernando Nangole, Nicolás Pinto, Pierlugi Tos, Asimb Bashir, Patrick Will, Quillan Young Sing, Raquel García Albea, Sarah Lonie, Richard Thomson, José Valle Cruz, Vicente Guimera, Virginia García Virto, Aleksandra Winiarska. Funding statement: This study was funded entirely by its authors References Berner JE, Ortíz-Llorens M, Fries CA, Nanchahal J, Jain A. Quality of Life after Open Extremity Trauma (QUINTET) study: an international, multicentric, observational, cohort study of quality of life following lower extremity open fractures. Journal of Plastic, Reconstructive & Aesthetic Surgery . Published online October 2024. doi:10.1016/j.bjps.2024.10.025 Eccles S, Handley B, Khan U, McFadyen I, Nanchahal J, Nayagam S. Standards for the Management of Open Fractures . Oxford University Press; 2020. doi:10.1093/med/9780198849360.001.0001 National Institute for Care Excellence (NICE). Fractures (Complex): Assessment and Management . NICE; 2016. Accessed July 4, 2020. https://www.nice.org.uk/guidance/ng37 Berner JE, Chan JKK, Gardiner MD, et al. International Lower Limb Collaborative (INTELLECT) study: a multicentre, international retrospective audit of lower extremity open fractures. British Journal of Surgery . 2022;109(9):792-795. doi:10.1093/BJS/ZNAC105 Berner JE, Ali SR, Will PA, Tejos R, Nanchahal J, Jain A. Standardising the management of open extremity fractures: a scoping review of national guidelines. Eur J Orthop Surg Traumatol . Published online 2022. doi:10.1007/S00590-022-03324-W Berner JE, Pope A, Hamilton DW, Nanchahal J, Jain A. Avoiding “a piece of paper on the wall that everyone ignores”: a qualitative study on the barriers for implementing open fracture guidelines. Injury . 2024;55(12):112018. doi:10.1016/j.injury.2024.112018 Eccles MP, Mittman BS. Welcome to Implementation Science. Implementation Science . 2006;1(1):1. doi:10.1186/1748-5908-1-1 Nilsen P. Making sense of implementation theories, models and frameworks. Implementation Science . 2015;10(1):53. doi:10.1186/s13012-015-0242-0 Rycroft-Malone J, Bucknall T. Theory, frameworks, and models. Models and frameworks for implementing evidence-based practice: Linking evidence to action . 2010;23. Jabareen Y. Building a Conceptual Framework: Philosophy, Definitions, and Procedure. Int J Qual Methods . 2009;8(4):49-62. doi:10.1177/160940690900800406 Levering B. Concept Analysis as Empirical Method. Int J Qual Methods . 2002;1(1):35-48. doi:10.1177/160940690200100104 Keeney Sinead, Hasson Felicity, McKenna HP, Wiley InterScience (Online service). The Delphi Technique in Nursing and Health Research . Wiley-Blackwell; 2011. doi:10.1002/9781444392029 Keeney S, Hasson F, McKenna H. Consulting the oracle: ten lessons from using the Delphi technique in nursing research. J Adv Nurs . 2006;53(2):205-212. doi:10.1111/j.1365-2648.2006.03716.x Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs . 2000;32(4):1008-1015. doi:10.1046/j.1365-2648.2000.t01-1-01567.x Additional Declarations No competing interests reported. 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The management of patients suffering from these involves interventions that address both the skeletal and soft tissue components, with the aim of achieving bony stabilisation, adequate cover and avoidance of infective complications. In the United Kingdom, clinical guidelines have been introduced to standardise the treatment of open lower limb fractures, advocating for a multidisciplinary approach to these injuries in centres where specialist care can be provided\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAlthough there is evidence that being treated in a setting with clinical guidelines for open lower limb fractures is associated with expedited treatment and better outcomes\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e, we have found that very few countries have developed such documents to date\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Despites their potential benefits clinical guidelines remain an exception rather than the norm at an international level.\u003c/p\u003e \u003cp\u003eThe recently published LINEAGE study described the multiple challenges involved in developing and implementing guidelines in settings that do not have one at present\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. Considering the potential benefits of clinical guidelines in managing open fractures, we aimed to develop a framework to aid optimising the uptake of evidence, in the form of clinical guidelines, for managing these injuries. The article summarises the process that led to the development of this framework along and a Delphi study used to achieve its validation.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eDevelopment of framework proposal\u003c/h2\u003e \u003cp\u003eImplementation science is the rigorous study of methods to achieve the systematic adoption of evidence into policy and routine practice\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. This discipline recognises the importance of establishing a theoretical basis for implementing change and the importance of qualitative research in the development of frameworks\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. These provide a structured graphical or narrative representation of a system, presenting the concepts or variables that interact with each other in relation to the phenomenon of interest \u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe development of frameworks in implementation science is the result of a process of qualitative theorisation, in which ontological and epistemological assumptions are made. Each concept is created, acquiring meaning on its own as an observation is synthesised, remaining different from other concepts while relating to them \u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. A framework is not merely a collection of these concepts or ideas, but rather a construct that aims to interpret a reality. They do not necessarily provide a causal or deterministic explanation but rather provide an understanding of a phenomenon\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003e The LINEAGE study analysis provided the necessary building blocks to proceed with the conceptualisation of a framework for the development and implementation of guidelines for open lower limb injuries. The aim was to present current challenges, while proposing a strategy to assist in the uptake of evidence to improve the care for patients with such injuries (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAt the centre of the proposed framework, a single concept is presented, epitomising the main goal for this framework: \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eeffective guideline implementation\u003c/span\u003e. Around this principal concept, four clusters of ideas are presented, each one playing a role in succeeding to achieve the aim at its centre.\u003c/p\u003e \u003cp\u003eAbove the central aim of this framework, the first concept encountered is \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eclinician\u003c/span\u003e. This item acknowledges their role in the decision-making that defines the treatment for patients with open fractures. As previously discussed, guidelines have the potential to modify clinicians\u0026rsquo; behaviour by offering \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eevidence-based recommendations\u003c/span\u003e. However, LINEAGE highlighted the importance of \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eauditing practice\u003c/span\u003e to avoid the unfortunate situation of having a robustly developed guideline that is not followed. Awareness of the quality of care delivered allows not only to measure adherence to recommendations, but it also provides \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003efeedback\u003c/span\u003e for future improvement.\u003c/p\u003e \u003cp\u003eTowards the right side of the diagram, a second cluster is presented in shades of green, focusing on the importance of multidisciplinary collaboration and \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eteam\u003c/span\u003e dynamics. Lack of \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eclear pathways for collaboration\u003c/span\u003e was highlighted in LINEAGE as a problem for delivering timely and coordinated care for patients with open fractures. Implementing a guideline can address this, by establishing who, when and how different specialties should intervene. However, LINEAGE also highlighted how positive \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003einterpersonal relationships\u003c/span\u003e can be beneficial in delivering patient care. Instead of assuming that guidelines will replace natural human interaction, the framework proposal acknowledges the importance of team building to achieve its goal. Finally, this cluster includes the concept of \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eleadership\u003c/span\u003e, as a catalyst in this process.\u003c/p\u003e \u003cp\u003eAt the bottom of the diagram, I decided to include a third cluster, also associated with a theme previously discussed in the LINEAGE analysis: the immobile \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003esystemic factors\u003c/span\u003e directly limit the effective implementation of guidelines. This aspect of the framework intends to provide a realistic approach to achieving its goal. Prioritising \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eachievable goals\u003c/span\u003e refers to the fact that not all evidence-based recommendations may be feasible to implement in settings where the minimal systemic conditions have not yet been met. This should be aligned with \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003emanaging expectations\u003c/span\u003e, to avoid unrealistic assumptions and the frustration that would be associated with failing to deliver an \u0026ldquo;ideal\u0026rdquo; package of care. However, awareness of the role that systemic limitations play in treating patients open fractures would also enable clinicians in their \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eadvocacy\u003c/span\u003e role in system improvement with the relevant stakeholders.\u003c/p\u003e \u003cp\u003e Finally, and placed at the left of the central aim of this framework, I included a series of concepts which have been recognised in the literature as key elements in the process of introducing novel guidelines. These are not necessarily related to the healthcare system factors discussed previously, but rather the cross-cultural differences that require attention in implementing evidence-based recommendations. \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eLocal culture\u003c/span\u003e should always be considered, as patient and clinician attitude towards the same recommendation may vary in different settings. \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eLanguage\u003c/span\u003e considerations are especially important if a foreign guideline is adopted, even more so if a translation is required.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eDelphi validation\u003c/h3\u003e\n\u003cp\u003eA modified Delphi study was designed to validate the framework presented above. The protocol for this project was shared with the University of Oxford CUREC for evaluation. This was reviewed by the Medical Sciences Division Ethics Committee, and on the 13th of September 2024 we received confirmation that no further ethical considerations were required.\u003c/p\u003e \u003cp\u003eEligible participants for this study were fully qualified orthopaedic, plastic or general surgeon with a clinical interest in open fractures. Utilising a purposive sampling strategy, all senior INTELLECT investigators based in countries with no current guidelines were contacted. An invitation was also circulated in ICOPLAST and International Microsurgery Club channels, allowing for snowballing recruitment to take place. The JISC Online Survey platform (JISC, UK) was used to design a virtual registration form to gather updated contact details and eligibility information from prospective respondents.\u003c/p\u003e \u003cp\u003eThe first round of this modified Delphi study consisted in the development of a series of statements that summarised each of the concepts included in the previously presented framework proposal. These were phrased in a way to allow respondents to express their level of agreement using Likert-style answers in subsequent rounds. These were compiled in a virtual survey that allowed participants to record their degree of agreement or disagreement for each statement individually. Five statements regarding the framework proposal in general, its clarity and applicability. (Appendix 1).\u003c/p\u003e \u003cp\u003eFor the second round of this Delphi study, participants were sent a unique link to the finalised questionnaire, with a deadline of two weeks to respond. The results were exported into a password-protected Excel spreadsheet stored on the University of Oxford OneDrive. Descriptive statistical analysis was performed using SPSS software to portray the participating sample of experts using the information obtained. Frequencies and proportions were calculated for each Likert-style question, along with their corresponding mean value and IQR.\u003c/p\u003e \u003cp\u003eIn order to determine the need of subsequent Delphi rounds, three criteria were had to be met to achieve a consensus. Statements that exceeded an agreement threshold of 80%, with an associated IQR of 1 or less and a mean Likert response of 4.5, were automatically considered validated, with no further testing required. Statements that did not initially meet these three criteria, would qualify for a third Delphi round, allowing for the assessment of response stability. In this further questionnaire, participants were presented with any statement that had not yet achieved validation, along with the previous round response percentages and means. Statement that maintained agreement levels above 80% and IQR of 1 or less in the third round were also considered validated. Any statements that did not accomplish this would procced to be discarded from the framework proposal (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eValidation of individual concepts\u003c/h2\u003e \u003cp\u003eThe participant recruitment phase for this Delphi study ran from the 25th of September until the 2nd of October 2024. During this period a total of 53 plastic, orthopaedic and general surgeons expressed their intention to participate. All 53 complied with the pre-defined inclusion and exclusion criteria.\u003c/p\u003e \u003cp\u003eAs previously mentioned, the first Delphi round did not involve expert participation. The second Delphi round took place from the 2nd to the 16th of October 2024. Of the 53 invited participants, 43 completed their enrolment by providing consent and fully answering the questionnaire. Twenty (47%) of the respondents identified themselves as orthopaedic surgeons, 23 (53%) as plastic and reconstructive surgeons, with 14 (33%) of participants being female. The median reported time in practice after specialist certification was 9 years Enrolled participants were based in 15 different countries, including the United States (n\u0026thinsp;=\u0026thinsp;7), Canada (n\u0026thinsp;=\u0026thinsp;2), Spain (n\u0026thinsp;=\u0026thinsp;9), Italy (n\u0026thinsp;=\u0026thinsp;3), Germany (n\u0026thinsp;=\u0026thinsp;1), Poland (n\u0026thinsp;=\u0026thinsp;1), Sweden (n\u0026thinsp;=\u0026thinsp;1), Israel (n\u0026thinsp;=\u0026thinsp;2), Syria (n\u0026thinsp;=\u0026thinsp;1), Pakistan (n\u0026thinsp;=\u0026thinsp;1), Taiwan (n\u0026thinsp;=\u0026thinsp;2), Kenya (n\u0026thinsp;=\u0026thinsp;2), Chile (n\u0026thinsp;=\u0026thinsp;9), Trinidad and Tobago (n\u0026thinsp;=\u0026thinsp;1), and Australia (n\u0026thinsp;=\u0026thinsp;1).\u003c/p\u003e \u003cp\u003eAll statements received a positive response overall (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Eight of these achieved the pre-defined threshold for validation at this stage, including all statements related to clinician factors and team factors. Additionally, the health system statement regarding the role of advocacy also met this threshold. Although the remaining statements presented agreement levels above 80%, their obtained mean response was below 4.5. As per our protocol, this latter group required further testing in a subsequent Delphi round that followed.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSecond round Delphi results. Validated statements highlighted in green\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003eClinician factors\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Recommendations should be based in best available evidence to positively influence clinician decision-making.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e81%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2. Continuous audit of care and outcomes should be encouraged as part of implementation.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e79%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3. Feedback from audits should be used to measure guideline compliance, as a driver for continuous quality improvement.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e77%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTeam factors\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4. Open fractures should be managed within multidisciplinary teams able to provide complex interventions, addressing bone and soft tissues.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e21%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e74%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5. Clear pathways for collaboration across specialties are desirable to optimise patient care, while reducing variability.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e70%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6. The positive effect of good interpersonal relationships among clinicians favouring teamwork and inter-specialty collaboration should be recognised.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e40%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e58%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7. Positive leadership is necessary to facilitate collaboration among a multi-disciplinary team.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e35%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e65%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHealth system factors\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8. Open fracture management is inevitably influenced by health system factors that clinicians cannot easily change.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e51%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e35%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e9. Health system factors should be considered when developing an open fracture guideline, so that any recommendation is feasible in real-world scenarios.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e42%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e49%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10. Expectations should be managed when implementing an open fracture guideline, especially when foreign guideline adaptation is being considered.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e53%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e33%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e11. Although gold-standard care may not always be feasible, awareness of ideal best practice is important, so that effective advocacy is possible.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e23%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e74%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSocio-cultural factors\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12. Appreciating cultural and language factors is crucial in the development of guidelines for open fracture management. This is especially relevant when an adaptation is considered.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e33%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e49%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003e1: strongly disagree / 2: disagree / 3: undecided / 4: agree / 5: strongly agree\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eOn the 24th of October 2024 participants were contacted again via email and presented with the results of the previous questionnaire. For this third Delphi round, a shorter version of the questionnaire was used, focusing on the statements that had not achieved validation previously. Statements regarding overall framework validation were kept, to assess response stability. As previously, participants were given two weeks to respond.\u003c/p\u003e \u003cp\u003eA total of 37 participants completed this subsequent questionnaire. The results showed strong and persistent validation of three of the four statements assessed (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Statement number eight, which referred to the fact that open fracture management is inevitably influenced by health system factors, did not achieve the threshold for validation and was discarded from the framework proposal.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThird round Delphi results. Validated statements highlighted in green.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8. Open fracture management is inevitably influenced by health system factors that clinicians cannot easily change.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e65%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e9. Health system factors should be considered when developing an open fracture guideline, so that any recommendation is feasible in real-world scenarios.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e35%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e65%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10. Expectations should be managed when implementing an open fracture guideline, especially when foreign guideline adaptation is being considered.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e70%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e27%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12. Although gold-standard care may not always be feasible, awareness of ideal best practice is important, so that effective advocacy is possible.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e43%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e49%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003e1: strongly disagree / 2: disagree / 3: undecided / 4: agree / 5: strongly agree\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eGeneral framework validation\u003c/h3\u003e\n\u003cp\u003eParticipants were presented with statements that assessed comprehensiveness, conceptualisation, ease of understanding, logic, practicality, and applicability to assess general framework validation. These statements were measured twice, in the second and third Delphi rounds to capture the overall impression of the experts regarding the framework proposal. On both occasions, a positive response was recorded for all these global validation statements. As expected, as the Delphi progressed there was a tendency towards moderation and fewer outliers, while maintaining levels of agreement above 80% (Table\u0026nbsp;3)\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003e This article introduces a framework to aid in the development and implementation of clinical practice guidelines for lower limb open fractures, with the aim of optimising the uptake of evidence to improve the management and outcomes for these patients. The Delphi study summarised in this manuscript was able to achieve a consensus on the majority of elements included in this framework. All but one of the statements included in the Delphi questionnaire were successfully validated. Furthermore, participants consistently responded positively to the framework as a whole, in terms of comprehensiveness, logic and applicability.\u003c/p\u003e \u003cp\u003eAlthough Delphi methodology offers a pragmatical strategy for seeking consensus among experts, there are limitations to this approach. For this study we defined that any orthopaedic or plastic surgeon with an interest in open lower extremity fractures would qualify as an expert. We considered that this would be a reasonable assumption, having in mind that clinicians with undergraduate and postgraduate training are experts in their field \u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Furthermore, we specifically aimed for this group as they are in the best position to provide peer-validation as potential early adopters of this framework. However, this study did not include feedback from other stakeholders, such as patient representatives, managers and policymakers. Further research including these groups would provide valuable insight to improve and further validate the framework presented in this chapter.\u003c/p\u003e \u003cp\u003e We took a pragmatical approach in terms of the participant selection, reaching out to previous collaborators and their adjacent networks. Although this strategy was successful in terms of recruitment and engagement, it is important recognise that it may have introduced selection bias. In other words, clinicians who have previously participated in open fracture research may have a positive attitude towards the uptake of evidence in open lower limb trauma care. We tried to address this by introducing heterogeneity in respondents by allowing for snowballing effect, resulting in the recruitment of clinicians with whom we had no previous contact. Unfortunately there is no consensus regarding an ideal strategy for recruitment in Delphi methodology\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Similarly, there is no available guidance concerning the ideal size of a panel of experts for this kind of studies, and there is no evidence to suggest that a larger sample would be beneficial to achieve the research aims\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhile the results of this Delphi study validated most of the elements of the framework proposal, it also allowed the identification of areas that needed addressing. On concrete example is the single statement that did not achieve the threshold for validation. This referred to the observation that open fractures are inevitably influenced by health system factors that clinicians cannot easily change. Although the majority of respondents agreed to an extent with this, it is challenging to identify what was the primary source for disagreement. Considering that the remaining health system factors statements were validated, we hypothesise that the source of the dispute was not the assertion that health systems play a role, but the fact that clinicians cannot easily change them. This may reflect that some respondents may have a more positive attitude than us regarding the capacity that clinicians have for changing the systems in which they work. Due to the fact that this item was not validated in the Delphi study, we decided to remove this slightly contentious statement from the final framework proposal (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTable 5.3 Overall framework validation results.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"642\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOverall framework validation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIQR\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eThis framework provides a comprehensive overview of the key elements that should be considered in the process of developing and implementing guidelines for open lower limb fractures.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 2:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e12%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e44%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e44%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 3:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e49%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e51%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eThis framework conceptualises the process of guideline development and implementation, so that it can be applied in settings where no guidelines exist at present.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 2:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e53%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e40%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 3:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e59%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e36%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eIt is easy to understand the concepts included in this framework, along with their relevance in the process of guideline development and implementation.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 2:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e12%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e49%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e33%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 3:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e70%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e27%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eThe relationships between the concepts included in this framework are logical and practical.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 2:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e2%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e12%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e46%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e40%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 3:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e68%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e24%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eThis framework has the potential of being a useful resource in the development and implementation of open fracture guidelines.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 2:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e2%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e14%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e44%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e40%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 293px;\"\u003e\n \u003cp\u003eDelphi round 3:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e62%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 41px;\"\u003e\n \u003cp\u003e35%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 45px;\"\u003e\n \u003cp\u003e4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"8\" valign=\"top\" style=\"width: 642px;\"\u003e\n \u003cp\u003e1: strongly disagree / 2: disagree / 3: undecided / 4: agree / 5: strongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eValidated framework proposal\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"1\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClinician factors\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Recommendations should be based in best available evidence to positively influence clinician decision-making.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2. Continuous audit of care and outcomes should be encouraged as part of implementation.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3. Feedback from audits should be used to measure guideline compliance, as a driver for continuous quality improvement.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTeam factors\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4. Open fractures should be managed within multidisciplinary teams able to provide complex interventions, addressing bone and soft tissues.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5. Clear pathways for collaboration across specialties are desirable to optimise patient care, while reducing variability.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6. The positive effect of good interpersonal relationships among clinicians favouring teamwork and inter-specialty collaboration should be recognised.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7. Positive leadership is necessary to facilitate collaboration among a multi-disciplinary team.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHealth system factors\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8. Health system factors should be considered when developing an open fracture guideline, so that any recommendation is feasible in real-world scenarios.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e9. Expectations should be managed when implementing an open fracture guideline, especially if foreign guideline adaptation is being considered.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10. Although gold-standard care may not always be feasible, awareness of ideal best practice is important, enabling effective advocacy.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSocio-cultural factors\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e11. Appreciating cultural and language factors is crucial in the development of guidelines for open fracture management.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eDespite the outcome of the Delphi study included in this chapter, we understand that this framework may require further testing and refinement before and after it is put in practice. Future studies focusing on its application in a real-world scenario would provide further insight regarding its applicability and efficacy. To our knowledge this is the first framework described to aid in improving the management of open fractures. We look forward to its dissemination and discussion to continue refining this proposal.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eJ.E.B participated in the design of the study, gathered data, analysed the data, interpreted the data, prepared figures and tables and wrote manuscript. C.H participated in the design of the study, provided methodological support, assisted in the interpretation of the findings and reviewed the manuscript. J.N. and A.J provided methodological support, assisted in the interpretation of the findings and reviewed the manuscript\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003e We would like to thank the panel of experts that participated in this study, who are named below. As per our study protocol not all of them opted for being named in this manuscript.\u003c/p\u003e \u003cp\u003e Participating panel of experts: Alina Ortega-Briones, Ata Ul Haq, \u0026Aacute;lvaro Zamorano, Beatr\u0026iacute;z Ol\u0026iacute;as L\u0026oacute;pez, Carlos Fonfach, Chad Chang, Carlos Prada, Diana Crego-Vita, Ernesto Ewertz, Anton Fries, Gonzalo Aranda, Yung-Chen Chiu, Oriana Haran, Hari Castro, H\u0026eacute;ctor Aguado, Javier Mart\u0026iacute;nez Ros, Juan de Dios Err\u0026aacute;zuriz, Joaqu\u0026iacute;n Palma, Leonardo Parada, Lily Mundy, Antonella L\u0026oacute;pez, Luigi Troisi, Macarena Vizcay, Mania Mani, Roberto Mart\u0026iacute;nez, Fernando Nangole, Nicol\u0026aacute;s Pinto, Pierlugi Tos, Asimb Bashir, Patrick Will, Quillan Young Sing, Raquel Garc\u0026iacute;a Albea, Sarah Lonie, Richard Thomson, Jos\u0026eacute; Valle Cruz, Vicente Guimera, Virginia Garc\u0026iacute;a Virto, Aleksandra Winiarska.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eFunding statement:\u003c/strong\u003e This study was funded entirely by its authors\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBerner JE, Ort\u0026iacute;z-Llorens M, Fries CA, Nanchahal J, Jain A. Quality of Life after Open Extremity Trauma (QUINTET) study: an international, multicentric, observational, cohort study of quality of life following lower extremity open fractures. \u003cem\u003eJournal of Plastic, Reconstructive \u0026amp; Aesthetic Surgery\u003c/em\u003e. Published online October 2024. doi:10.1016/j.bjps.2024.10.025\u003c/li\u003e\n\u003cli\u003eEccles S, Handley B, Khan U, McFadyen I, Nanchahal J, Nayagam S. \u003cem\u003eStandards for the Management of Open Fractures\u003c/em\u003e. Oxford University Press; 2020. doi:10.1093/med/9780198849360.001.0001\u003c/li\u003e\n\u003cli\u003eNational Institute for Care Excellence (NICE). \u003cem\u003eFractures (Complex): Assessment and Management\u003c/em\u003e. NICE; 2016. Accessed July 4, 2020. https://www.nice.org.uk/guidance/ng37\u003c/li\u003e\n\u003cli\u003eBerner JE, Chan JKK, Gardiner MD, et al. International Lower Limb Collaborative (INTELLECT) study: a multicentre, international retrospective audit of lower extremity open fractures. \u003cem\u003eBritish Journal of Surgery\u003c/em\u003e. 2022;109(9):792-795. doi:10.1093/BJS/ZNAC105\u003c/li\u003e\n\u003cli\u003eBerner JE, Ali SR, Will PA, Tejos R, Nanchahal J, Jain A. Standardising the management of open extremity fractures: a scoping review of national guidelines. \u003cem\u003eEur J Orthop Surg Traumatol\u003c/em\u003e. Published online 2022. doi:10.1007/S00590-022-03324-W\u003c/li\u003e\n\u003cli\u003eBerner JE, Pope A, Hamilton DW, Nanchahal J, Jain A. Avoiding \u0026ldquo;a piece of paper on the wall that everyone ignores\u0026rdquo;: a qualitative study on the barriers for implementing open fracture guidelines. \u003cem\u003eInjury\u003c/em\u003e. 2024;55(12):112018. doi:10.1016/j.injury.2024.112018\u003c/li\u003e\n\u003cli\u003eEccles MP, Mittman BS. Welcome to Implementation Science. \u003cem\u003eImplementation Science\u003c/em\u003e. 2006;1(1):1. doi:10.1186/1748-5908-1-1\u003c/li\u003e\n\u003cli\u003eNilsen P. Making sense of implementation theories, models and frameworks. \u003cem\u003eImplementation Science\u003c/em\u003e. 2015;10(1):53. doi:10.1186/s13012-015-0242-0\u003c/li\u003e\n\u003cli\u003eRycroft-Malone J, Bucknall T. Theory, frameworks, and models. \u003cem\u003eModels and frameworks for implementing evidence-based practice: Linking evidence to action\u003c/em\u003e. 2010;23.\u003c/li\u003e\n\u003cli\u003eJabareen Y. Building a Conceptual Framework: Philosophy, Definitions, and Procedure. \u003cem\u003eInt J Qual Methods\u003c/em\u003e. 2009;8(4):49-62. doi:10.1177/160940690900800406\u003c/li\u003e\n\u003cli\u003eLevering B. Concept Analysis as Empirical Method. \u003cem\u003eInt J Qual Methods\u003c/em\u003e. 2002;1(1):35-48. doi:10.1177/160940690200100104\u003c/li\u003e\n\u003cli\u003eKeeney Sinead, Hasson Felicity, McKenna HP, Wiley InterScience (Online service). \u003cem\u003eThe Delphi Technique in Nursing and Health Research\u003c/em\u003e. Wiley-Blackwell; 2011. doi:10.1002/9781444392029\u003c/li\u003e\n\u003cli\u003eKeeney S, Hasson F, McKenna H. Consulting the oracle: ten lessons from using the Delphi technique in nursing research. \u003cem\u003eJ Adv Nurs\u003c/em\u003e. 2006;53(2):205-212. doi:10.1111/j.1365-2648.2006.03716.x\u003c/li\u003e\n\u003cli\u003eHasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. \u003cem\u003eJ Adv Nurs\u003c/em\u003e. 2000;32(4):1008-1015. doi:10.1046/j.1365-2648.2000.t01-1-01567.x\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"open fractures, framework, implementation science, Delphi study","lastPublishedDoi":"10.21203/rs.3.rs-6378469/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6378469/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction: \u003c/strong\u003eLower limb open fractures are severe injuries that can lead to long-term sequalae. Clinical guidelines for managing these patients are associated with expedited treatment and better outcomes. However, few countries have implemented guidelines for open lower limb fractures. The aim of this study was to develop and validate a framework for the introduction of clinical guidelines in settings that do not have one at present.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eUsing the qualitative analysis for the Limitations to the Implementation of Open Trauma Guidelines (LINEAGE) study, a framework proposal was designed. This included 4 clusters of inter-related concepts, including clinician, team, health and cultural factors. To validate this framework a modified Delphi study was devised. The elements of the framework were translated into 12 statements that were compiled in a Delphi questionnaire. A panel of orthopaedic and plastic surgeons was assembled to obtain structured feedback and assess the degree of consensus regarding the framework proposal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eUsing purposive sampling, 43 clinicians enrolled in an international expert panel, including 20 orthopaedic and 23 plastic surgeons based in countries with no guidelines at present. Following three Delphi rounds, 11 out of the 12 assessed statements achieved the threshold for validation. The single statement that did not reach consensus status was then removed from the framework.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion: \u003c/strong\u003eFrameworks are a well described aid in implementation science, being able to describe complexity and propose strategies for improvement. We present the first validated framework for the development and implementation of open fracture guidelines.\u003c/p\u003e","manuscriptTitle":"A framework for the development and implementation of open trauma guidelines: A Delphi consensus validation","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-08 12:17:15","doi":"10.21203/rs.3.rs-6378469/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5224a6e7-8c21-4f13-8a19-70038d495349","owner":[],"postedDate":"April 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-20T16:08:27+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-08 12:17:15","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6378469","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6378469","identity":"rs-6378469","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}