Consensus Development Research Articles

ACROPath Oligometastases: The American College of Radiation Oncology Clinical Pathway.

Radiation oncology is among the most data-driven specialties in medicine. Recently, a wealth of peer-reviewed data has been published supporting the treatment of oligometastatic malignancies, demonstrating improved survival with metastasis-directed therapy, such as stereotactic body radiation therapy (SBRT), when combined with appropriate patient selection and treatment. However, there are currently few, if any, established guidelines that synthesize the abundance of data specific to radiotherapy into a single, easily accessed resource for clinicians. ACROPath®is a major initiative of the American College of Radiation Oncology (ACRO) that aims to present aggregated clinical pathway data in a highly usable format that is readily accessible to clinicians at the point of care in real time. The oligometastases pathway is the first published algorithm in this collection, with additional pathways anticipated in future publications.Clinical radiation oncologists with expertise in the treatment and management of oligometastatic disease were recruited from across ACRO's diverse membership, including both academic and private practice physicians, to ensure a broad-based experience and insight. Individual participants were assigned subsections of the pathway for guideline development, and then, each subsection was presented to the full group for evaluation and consensus development based on published data. Rather than presenting an unstructured set of treatment options, as is common in other treatment guidelines, this initiative aimed to categorize appropriate treatments based on published clinical evidence in a hierarchy further ranked by efficacy, toxicity, and cost. Based on these strata, treatment recommendations were collated and grouped into three rank categories (gold, silver, or bronze) to denote the degree of applicability.The team assembled an interactive document that will eventually be available online, and it is summarized in detail here. Recommendations are grouped both by the anatomic site of metastasis and by the primary tumor type, recognizing that original histology might impact the treatment differently in different anatomic locations. After a review of available published clinical evidence, the committee reached a consensus on all recommendations presented, categorizing each option as gold, silver, or bronze to guide clinicians appropriately. This first iteration of ACROPath®Oligometastases represents one of the few comprehensive clinical decision support tools available for managing patients with limited metastatic disease. It presents available data in a highly accessible, easily used reference, which will be formally reviewed and updated by the committee as frequently as emerging data requires, likely at six- to 12-month intervals.

The role of dietary modification in the prevention and management of metabolic dysfunction-associated fatty liver disease: An international multidisciplinary expert consensus

Metabolic dysfunction-associated fatty liver disease (MAFLD) or metabolic dysfunction-associated steatotic liver disease (MASLD), has become the leading cause of chronic liver disease worldwide. Optimal dietary intervention strategies for MAFLD are not standardized. This study aimed to achieve consensus on prevention of MAFLD through dietary modification. A multidisciplinary panel of 55 international experts, including specialists in hepatology, gastroenterology, dietetics, endocrinology and other medical specialties from six continents collaborated in a Delphi-based consensus development process. The consensus statements covered aspects ranging from epidemiology to mechanisms, management, and dietary recommendations for MAFLD. The recommended dietary strategies emphasize adherence to a balanced diet with controlled energy intake and personalized nutritional interventions, such as calorie restriction, high-protein, or low-carbohydrate diets. Specific dietary advice encouraged increasing the consumption of whole grains, plant-based proteins, fish, seafood, low-fat or fat-free dairy products, liquid plant oils, and deeply colored fruits and vegetables. Concurrently, it advised reducing the intake of red and processed meats, saturated and trans fats, ultra-processed foods, added sugars, and alcohol. Additionally, maintaining the Mediterranean or DASH diet, minimizing sedentary behavior, and engaging in regular physical activity are recommended. These consensus statements lay the foundation for customized dietary guidelines and proposing avenues for further research on nutrition and MAFLD.

Diagnosis and treatment of anterior cruciate ligament injuries: Consensus of Chinese experts part II: Graft selection and clinical outcome evaluation

BackgroundIn the recent decade, there has been substantial progress in the technologies and philosophies associated with diagnosing and treating anterior cruciate ligament (ACL) injuries in China. The therapeutic efficacy of ACL reconstruction in re-establishing the stability of the knee joint has garnered widespread acknowledgment. However, the path toward standardizing diagnostic and treatment protocols remains to be further developed and refined. ObjectiveIn this context, the Chinese Association of Orthopaedic Surgeons (CAOS) and the Chinese Society of Sports Medicine (CSSM) collaboratively developed an expert consensus on diagnosing and treating ACL injury, aiming to enhance medical quality through refining professional standards. MethodsThe consensus drafting team invited experts across the Greater China region, including the mainland, Hong Kong, Macau, and Taiwan, to formulate and review the consensus using a modified Delphi method as a standardization approach. As members of the CSSM Lower Limb Study Group and the CAOS Arthroscopy and Sports Medicine Study Group, invited experts concentrated on two pivotal issues: “Graft Selection” and “Clinical Outcome Evaluation” during the second part of the consensus development. ResultsThis focused discussion ultimately led to a strong consensus on nine specific consensus terms. ConclusionThe consensus clearly states that ACL reconstruction has no definitive “gold standard” graft choice. Autografts have advantages in healing capability but are limited in availability and have potential donor site morbidities; allografts reduce surgical trauma but incur additional costs, and there are concerns about slow healing, quality control issues, and a higher failure rate in young athletes; synthetic ligaments allow for early rehabilitation and fast return to sport, but the surgery is technically demanding and incurs additional costs. When choosing a graft, one should comprehensively consider the graft's characteristics, the doctor's technical ability, and the patient's needs. When evaluating clinical outcomes, it is essential to ensure an adequate sample size and follow-up rate, and the research should include patient subjective scoring, joint function and stability, complications, surgical failure, and the return to sport results. Medium and long-term follow-ups should not overlook the assessment of knee osteoarthritis.

FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study

IntroductionSelective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and...

Standards for conducting and reporting consensus and recommendation documents: European Society of Cardiovascular Radiology policy from the Guidelines Committee

Cardiovascular imaging is exponentially increasing in the diagnosis, risk stratification, and therapeutic management of patients with cardiovascular disease. The European Society of Cardiovascular Radiology (ESCR) is a non-profit scientific medical society dedicated to promoting and coordinating activities in cardiovascular imaging. The purpose of this paper, written by ESCR committees and Executive board members and approved by the ESCR Executive Board and Guidelines committee, is to codify a standardized approach to creating ESCR scientific documents. Indeed, consensus development methods must be adopted to ensure transparent decision-making that optimizes national and global health and reaches a certain scientific credibility. ESCR consensus documents developed based on a rigorous methodology will improve their scientific impact on the management of patients with cardiac involvement.Critical relevance statementThis document aims to codify the methodology for producing consensus documents of the ESCR. These ESCR indications will broaden the scientific quality and credibility of further publications and, consequently, the impact on the diagnostic management of patients with cardiac involvement.Key PointsCardiovascular imaging is exponentially increasing for diagnosis, risk stratification, and therapeutic management.The ESCR is committed to promoting cardiovascular imaging.A rigorous methodology for ESCR consensus documents will improve their scientific impact.

Consensus clustering and development of a risk signature based on trajectory differential genes of cancer-associated fibroblast subpopulations in colorectal cancer

BackgroundCancer-associated fibroblasts (CAFs) play a crucial role in the progression of colorectal cancer (CRC). However, the impact of CAF subpopulation trajectory differentiation on CRC remains unclear.MethodsIn this study, we first explored the trajectory differences of CAFs subpopulations using bulk and integrated single-cell sequencing data, and then performed consensus clustering of CRC samples based on the trajectory differential genes of CAFs subpopulations. Subsequently, we analyzed the heterogeneity of CRC subtypes using bioinformatics. Finally, we constructed relevant prognostic signature using machine learning and validated them using spatial transcriptomic data.ResultsBased on the differential genes of CAFs subpopulation trajectory differentiation, we identified two CRC subtypes (C1 and C2) in this study. Compared to C1, C2 exhibited worse prognosis, higher immune evasion microenvironment and high CAF characteristics. C1 was primarily associated with metabolism, while C2 was primarily associated with cell metastasis and immune regulation. By combining 101 combinations of 10 machine learning algorithms, we developed a High-CAF risk signatures (HCAFRS) based on the C2 characteristic gene. HCAFRS was an independent prognostic factor for CRC and, when combined with clinical parameters, significantly predicted the overall survival of CRC patients. HCAFRS was closely associated with epithelial-mesenchymal transition, angiogenesis, and hypoxia. Furthermore, the risk score of HCAFRS was mainly derived from CAFs and was validated in the spatial transcriptomic data.ConclusionIn conclusion, HCAFRS has the potential to serve as a promising prognostic indicator for CRC, improving the quality of life for CRC patients.

Bridging the gap in managing dry eye disease: a consensus report by the Taiwan society of cataract and refractive surgeons

BackgroundAn impaired ocular surface presents substantial challenges in terms of planning for cataract surgery. As a multifactorial ocular disorder, dry eye disease (DED) is common in the general population and prevalent in patients scheduled for lens replacement surgery. Cataract surgery can exacerbate DED and worsen several ocular parameters. Timely diagnosis and appropriate treatment of DED are vital to ensuring positive ophthalmic surgical outcomes.This consensus report of the Taiwan Society of Cataract and Refractive Surgeons (TSCRS) regarding the management of DED before, during, and after cataract surgery highlights the gaps between clinical guidelines and several aspects of DED, including diagnostic testing, diagnostic criteria, and clinical practice treatment.MethodsAn expert panel of five specialists in the field of ophthalmology was recruited to develop consensus statements regarding the management of DED in both the general population and in patients undergoing cataract surgery in Taiwan. Two separate meetings of the five specialists, who were endorsed by the TSCRS, were convened for this purpose. A survey questionnaire consisting of binary or multiple-choice questions was developed through a consensus-driven formulation process. A percentage value was calculated for each statement, and a minimum of 60% agreement (equivalent to three out of five members) was required to achieve consensus. The second discussion meeting involved the presentation of the finalized consensus statements and concluded the consensus development process. Lastly, the finalized consensus statements were approved by all the experts, and the formulated recommendations for DED in the general population and prospective cataract surgery patients were accordingly presented.ResultsThe optimal algorithm for managing DED in the general population and in patients scheduled for cataract surgery was developed to address the unmet needs of this cohort in Taiwan.ConclusionThis report provides recommendations for managing dry eye disease. It is essential to screen and confirm DED through endorsed questionnaires and tests and then diagnose it. Treatment and management of DED should follow a stepwise approach. Screening and diagnosing DED is also recommended before cataract surgery. After cataract surgery, relatively aggressive treatment strategies are recommended to manage DED effectively.

Genetic testing for childhood cancer predisposition syndromes: Controversies and recommendations from the SIOPE Host Genome Working Group meeting 2022

BackgroundCancer Predisposition Syndromes (CPSs) have been identified in 7–15 % of children with cancer. The possibilities for germline genetic testing have increased in recent years, presenting new opportunities but also challenges. There is currently no consensus on germline genetic testing in children with cancer in diagnostic settings. MethodsThe International Society of Pediatric Oncology Europe (SIOPE) Host Genome Working Group used a consensus development conference method to reach agreement on four key topics: Who do we test? Which genes do we test? What do we disclose? How do we evaluate the benefits of testing? ResultsThe Working Group members agreed that: (1) All children with cancer should undergo clinical screening for their risk of harboring a CPS. (2) Targeted genetic testing based on clinical indication is recommended. Comprehensive CPS gene panels with more than 100–150 genes for all children with cancer should preferably be evaluated within research settings. (3) Smaller actionable gene panels can be considered including genes supporting diagnosis or influencing treatment decisions. (4) Clear pre-test information and consenting processes that highlight potential outcomes and implications of germline genetic testing are imperative. (5) Consequences of genetic testing, treatment adaption, and tumor surveillance in children with CPSs, including economic impact and psychosocial factors, should be further explored. ConclusionsThese consensus-based recommendations provide guidance on germline genetic testing in children with cancer. Regular review of these recommendations is essential. Collaboration and the use of data sharing platforms can further improve screening procedures and its impact on care.

Current status of pediatric auditory brainstem implantation in inner ear malformations; consensus statement of the Third International Pediatric ABI Meeting

Objectives: This study aims to synthesize current knowledge and outcomes related to pediatric auditory brainstem implantation (ABI) in children with severe inner ear malformations (IEMs). It highlights the clinical management practices, challenges, and potential future directions for consensus development in this field. Methods: A systematic review of findings presented at the Third International Pediatric ABI Symposium organized by the Hacettepe Cochlear Implant team between 3 and 5 September 2020 was conducted, incorporating data from 41 departments across 19 countries. Relevant clinical outcomes, imaging techniques, surgical approaches, and rehabilitation strategies were analyzed to identify key trends and variability in practices. Results: The review indicates that children receiving ABIs exhibit diverse auditory outcomes influenced by individual anatomical variations and developmental factors. Early implantation, particularly before the age of three, positively correlates with better auditory and language development. Multicenter experiences underscore the necessity of tailored decision-making, which considers both surgical candidacy and comprehensive rehabilitation resources. Discussion:: The variability in outcomes emphasizes the need for improved consensus and guidelines regarding eligibility, surgical techniques, and multidisciplinary rehabilitation approaches. Notable complications and the necessity for thorough imaging assessments were also identified as critical components affecting clinical decisions. Conclusion: A formal consensus statement is warranted to standardize best practices in ABI management. This will not only enhance patient outcomes but also guide future research efforts to address the remaining challenges in the treatment of children with severe IEMs. Enhanced collaboration among team members will be pivotal in achieving these objectives.

Enhancing the Preanesthesia Evaluation: Consensus Development of the Cannabis Use and Behaviors Assessment Tool (CUBAT)

PurposeThis project aimed to develop an evidence-based preanesthesia cannabis use assessment tool to acquire complete and accurate patient history and develop a best-informed, individualized anesthesia and analgesia care plan. DesignModified Delphi. MethodsUsing an evidence synthesis and multistage, modified Delphi process, eight experts from across the United States developed a consensus-based tool to aid in developing a best-informed, individualized plan for anesthesia and analgesia care. FindingsTwo survey rounds integrated informed evidence-based tool revisions. The final tool included instructions for use, a glossary of terms, and seven key assessment items aimed at gathering the most influential information regarding cannabis use. ConclusionsThe Cannabis Use and Behaviors Assessment Tool is a first-of-its-kind tool providing an essential framework for preanesthesia cannabis use assessment.

Consensus on clinical drug therapy for knee osteoarthritis in China (2023)

Osteoarthritis (OA) is a heterogeneous disease that involves structural alterations in the articular cartilage, synovium, ligaments, subchondral bone, and the surrounding bone tissue. Among the various types of OA, knee osteoarthritis (KOA) is the most prevalent, presenting with symptoms such as joint pain, swelling, stiffness, and functional limitations. And its high disability rate places a significant burden on both individuals and society. Pharmacological intervention plays a crucial role in the comprehensive management of KOA. However, the establishment of standardized treatment protocols for the accurate and appropriate selection of medications for patients remain pressing clinical challenges. The Osteoarthritis Group of the Rheumatology and Immunology Physicians Branch of the Chinese Medical Doctor Association has developed this expert consensus by drawing upon current research findings, relevant guidelines, and consensus statements from both domestic and international sources. This consensus adheres to international standards for consensus development and incorporates input from a diverse panel of experts.The consensus encompasses six aspects: disease prevention, treatment goals, clinical typing, therapeutic drugs, follow-up and evaluation, and medication for comorbid populations. A total of 27 recommendations are put forward, aiming to provide clinicians with guidance for the safe and standardized use of drugs, thereby improving the diagnosis and treatment level of KOA and benefiting patients.

European Robotic Surgery Consensus (ERSC): Protocol for the development of a consensus in robotic training for gastrointestinal surgery trainees.

The rapid adoption of robotic surgical systems across Europe has led to a critical gap in training and credentialing for gastrointestinal (GI) surgeons. Currently, there is no existing standardised curriculum to guide robotic training, assessment and certification for GI trainees. This manuscript describes the protocol to achieve a pan-European consensus on the essential components of a comprehensive training programme for GI robotic surgery through a five-stage process. In Stage 1, a Steering Committee, consisting of international experts, trainees and educationalists, has been established to lead and coordinate the consensus development process. In Stage 2, a systematic review of existing multi-specialty robotic training curricula will be performed to inform the formulation of key position statements. In Stage 3, a comprehensive survey will be disseminated across Europe to capture the current state of robotic training and identify potential challenges and opportunities for improvement. In Stage 4, an international panel of GI surgeons, trainees, and robotic theatre staff will participate in a three-round Delphi process, seeking ≥ 70% agreement on crucial aspects of the training curriculum. Industry and patient representatives will be involved as external advisors throughout this process. In Stage 5, the robotic training curriculum for GI trainees will be finalised in a dedicated consensus meeting, culminating in the production of an Explanation and Elaboration (E&E) document. The study protocol has been registered on the Open Science Framework (https://osf.io/br87d/).

Application of the Delphi method to the development of common data elements for social drivers of health: A systematic scoping review.

Collaborative data science requires standardized, harmonized, interoperable, and ethically sourced data. Developing an agreed-upon set of elements requires capturing different perspectives on the importance and feasibility of the data elements through a consensus development approach. This study reports on the systematic scoping review of literature that examined the inclusion of diverse stakeholder groups and sources of social drivers of health variables in consensus-based common data element (CDE) sets. This systematic scoping review included sources from PubMed, Embase, CINAHL, WoS MEDLINE, and PsycINFO databases. Extracted data included the stakeholder groups engaged in the Delphi process, sources of CDE sets, and inclusion of social drivers data across 11 individual and 6 social domains. Of the 384 studies matching the search string, 22 were included in the final review. All studies involved experts with healthcare expertise directly relevant to the developed CDE set, and only six (27%) studies engaged health consumers. Literature reviews and expert input were the most frequent sources of CDE sets. Seven studies (32%) did not report the inclusion of any demographic variables in the CDE sets, and each demographic SDoH domain was included in at least one study with age and sex assigned at birth included in all studies, and social driver domains included only in four studies (18%). The Delphi technique engages diverse expert groups around the development of SDoH data elements. Future studies can benefit by involving health consumers as experts.

Digital Mental Health for Schizophrenia and Other Severe Mental Illnesses: An International Consensus on Current Challenges and Potential Solutions.

Digital approaches may be helpful in augmenting care to address unmet mental health needs, particularly for schizophrenia and severe mental illness (SMI). An international multidisciplinary group was convened to reach a consensus on the challenges and potential solutions regarding collecting data, delivering treatment, and the ethical challenges in digital mental health approaches for schizophrenia and SMI. The consensus development panel method was used, with an in-person meeting of 2 groups: the expert group and the panel. Membership was multidisciplinary including those with lived experience, with equal participation at all stages and coproduction of the consensus outputs and summary. Relevant literature was shared in advance of the meeting, and a systematic search of the recent literature on digital mental health interventions for schizophrenia and psychosis was completed to ensure that the panel was informed before the meeting with the expert group. Four broad areas of challenge and proposed solutions were identified: (1) user involvement for real coproduction; (2) new approaches to methodology in digital mental health, including agreed standards, data sharing, measuring harms, prevention strategies, and mechanistic research; (3) regulation and funding issues; and (4) implementation in real-world settings (including multidisciplinary collaboration, training, augmenting existing service provision, and social and population-focused approaches). Examples are provided with more detail on human-centered research design, lived experience perspectives, and biomedical ethics in digital mental health approaches for SMI. The group agreed by consensus on a number of recommendations: (1) a new and improved approach to digital mental health research (with agreed reporting standards, data sharing, and shared protocols), (2) equal emphasis on social and population research as well as biological and psychological approaches, (3) meaningful collaborations across varied disciplines that have previously not worked closely together, (4) increased focus on the business model and product with planning and new funding structures across the whole development pathway, (5) increased focus and reporting on ethical issues and potential harms, and (6) organizational changes to allow for true communication and coproduction with those with lived experience of SMI. This study approach, combining an international expert meeting with patient and public involvement and engagement throughout the process, consensus methodology, discussion, and publication, is a helpful way to identify directions for future research and clinical implementation in rapidly evolving areas and can be combined with measurements of real-world clinical impact over time. Similar initiatives will be helpful in other areas of digital mental health and similarly fast-evolving fields to focus research and organizational change and effect improved real-world clinical implementation.

Definition of Implanted Neurological Device Abandonment: A Systematic Review and Consensus Statement.

Establishing a formal definition for neurological device abandonment has the potential to reduce or to prevent the occurrence of this abandonment. To perform a systematic review of the literature and develop an expert consensus definition for neurological device abandonment. After a Royal Society Summit on Neural Interfaces (September 13-14, 2023), a systematic English language review using PubMed was undertaken to investigate extant definitions of neurological device abandonment. Articles were reviewed for relevance to neurological device abandonment in the setting of deep brain, vagal nerve, and spinal cord stimulation. This review was followed by the convening of an expert consensus group of physicians, scientists, ethicists, and stakeholders. The group summarized findings, added subject matter experience, and applied relevant ethics concepts to propose a current operational definition of neurological device abandonment. Data collection, study, and consensus development were done between September 13, 2023, and February 1, 2024. The PubMed search revealed 734 total articles, and after review, 7 articles were found to address neurological device abandonment. The expert consensus group addressed findings as germane to neurological device abandonment and added personal experience and additional relevant peer-reviewed articles, addressed stakeholders' respective responsibilities, and operationally defined abandonment in the context of implantable neurotechnological devices. The group further addressed whether clinical trial failure or shelving of devices would constitute or be associated with abandonment as defined. Referential to these domains and dimensions, the group proposed a standardized definition for abandonment of active implantable neurotechnological devices. This study's consensus statement suggests that the definition for neurological device abandonment should entail failure to provide fundamental aspects of patient consent; fulfill reasonable responsibility for medical, technical, or financial support prior to the end of the device's labeled lifetime; and address any or all immediate needs that may result in safety concerns or device ineffectiveness and that the definition of abandonment associated with the failure of a research trial should be contingent on specific circumstances.

Clinical Care Pathway and Management of Major Bleeding Associated with Nonvitamin K Antagonist Oral Anticoagulants: A Modified Delphi Consensus from Saudi Arabia and UAE.

The nonvitamin K antagonist oral anticoagulants (NOACs) have become the mainstay anticoagulation therapy for patients requiring oral anticoagulants (OACs) in the Gulf Council Cooperation (GCC) countries. The frequency of NOAC-associated major bleeding is expected to increase in the Emergency Department (ED). Nonetheless, we still lack local guidelines and recommendations for bleeding management in the region. The present Delphi-based consensus aims to establish a standardized and evidence-based clinical care pathway for managing NOAC-associated major bleeding in the Kingdom of Saudi Arabia (KSA) and the United Arab Emirates (UAE). We adopted a three-step modified Delphi method to develop evidence-based recommendations through two voting rounds and an advisory meeting between the two rounds. A panel of 11 experts from the KSA and UAE participated in the consensus development. Twenty-eight statements reached the consensus level. These statements addressed key aspects of managing major bleeding events associated with NOACs, including the increased use of NOAC in clinical practice, clinical care pathways, and treatment options. The present Delphi consensus provides evidence-based recommendations and protocols for the management of NOAC-associated bleeding in the region. Patients with major DOAC-induced bleeding should be referred to a well-equipped ED with standardized management protocols. A multidisciplinary approach is recommended for establishing the association between NOAC use and major bleeding. Treating physicians should have prompt access to specific reversal agents to optimize patient outcomes. Real-world evidence and national guidelines are needed to aid all stakeholders involved in NOAC-induced bleeding management.

An international multidisciplinary consensus on pediatric metabolic dysfunction-associated fatty liver disease

Non-alcoholic fatty liver disease (NAFLD) is highly prevalent in children and adolescents, particularly those with obesity. NAFLD is considered a hepatic manifestation of the metabolic syndrome due to its close associations with abdominal obesity, insulin resistance, and atherogenic dyslipidemia. Experts have proposed an alternative terminology, metabolic dysfunction-associated fatty liver disease (MAFLD), to better reflect its pathophysiology. This study aimed to develop consensus statements and recommendations for pediatric MAFLD through collaboration among international experts. A group of 65 experts from 35 countries and six continents, including pediatricians, hepatologists, and endocrinologists, participated in a consensus development process. The process encompassed various aspects of pediatric MAFLD, including epidemiology, mechanisms, screening, and management. In round 1, we received 65 surveys from 35 countries and analyzed these results, which informed us that 73.3% of respondents agreed with 20 draft statements while 23.8% agreed somewhat. The mean percentage of agreement or somewhat agreement increased to 80.85% and 15.75%, respectively, in round 2. The final statements covered a wide range of topics related to epidemiology, pathophysiology, and strategies for screening and managing pediatric MAFLD. The consensus statements and recommendations developed by an international expert panel serve to optimize clinical outcomes and improve the quality of life for children and adolescents with MAFLD. These findings emphasize the need for standardized approaches in diagnosing and treating pediatric MAFLD. This work was funded by the National Natural Science Foundation of China (82070588, 82370577), the National Key R&D Program of China (2023YFA1800801), National High Level Hospital Clinical Research Funding (2022-PUMCH-C-014), the Wuxi Taihu Talent Plan (DJTD202106), and the Medical Key Discipline Program of Wuxi Health Commission (ZDXK2021007).

P057 Scoping the role of the physiotherapist in the axial spondyloarthritis new patient clinic

Abstract Background/Aims Early diagnosis of Axial Spondyloarthritis (Axial SpA) is crucial to reduce negative impacts and support better patient outcomes through early intervention. There are a number of challenges contributing to delayed diagnosis, the focus of this report relates to the capacity pressures limiting timely assessment and diagnosis. There are a number of well-established, and more recently initiated, physiotherapist-led Axial SpA new patient clinics across UK Rheumatology. These clinics have been locally reported to reduce delays in diagnosis. There is growing interest from other rheumatology services to establish these clinics. A working group of physiotherapists providing physiotherapist-led Axial SpA clinics were supported by a BRITSpA Travelling Fellowship Grant to meet to share service experiences and to develop a consensus-driven best-practice set of recommendations to guide planning and implementing physiotherapist-led Axial SpA new patient assessment clinics in rheumatology departments across the UK. The aim of this report is to provide an overview of the two day Travelling Fellowship project process and the key initial outcomes from the workshop. Methods A two-day workshop attended by ten physiotherapists meeting in person and four joining virtually, all with expertise in providing physiotherapist-led new and review Axial SpA clinics. The workshop programme included presentations from national and international experts, encompassing GIRFT input, exemplar consensus development examples and an opportunity for all fellows to share their experience in setting up and delivering physiotherapist-led Axial SpA new patient clinics. Discussion time was prioritised to allow shared learning, discussion of similarities and local variations to support information gathering and the development of expert consensus-driven guidelines and implementation advice. Patient and public involvement was embedded into the workshop supporting planning discussions and providing lived experience perspectives, preferences and values concerning the implementation and service delivery discussions. Results The major themes and findings identified included the variation in role description and specific responsibilities between centres, including variation in support and mentoring available as well as administration time. However, similar outcomes were found regarding levels of confidence and independence in undertaking thorough triage and assessments of inflammatory back pain referrals leading to confirming or excluding Axial SpA diagnoses, and the skillset to manage these outcomes. Conclusion Following GIRFT recommendations, and in light of the workforce crisis in rheumatology, with support from the rheumatology physiotherapy capabilities framework we have seen the expansion of the physiotherapist role. We have good levels of confidence, following our sharing of clinic data and patient experience comments, that there is a valuable contribution to the rheumatology landscape to be made by physiotherapist-led Axial SpA new patient clinics. Disclosure W.J. Gregory: Honoraria; W.G. has received honoraria for speaking and advisory board from Abbvie, Novartis, Pfizer, Sobi and UCB. R. Adshead: None. Z. Cox: None. E.E. Deeney: None. P.A. Dowie: None. S.J. Fish: None. R. Galway: None. H. Harrison: None. R.J. Hayward: Honoraria; R.H. has received honoraria for speaking from Abbive and Novartis. C. Longton: Honoraria; C.L. has received honoraria for speaking from UCB. M. Motion: None. C. Tonks: None. C. McCrum: Honoraria; C.McC. has received honoraria for professional education workshops- Novartis, Janssen.

Getting to Fidelity: Consensus Development Process to Identify Core Activities of Implementation Facilitation

Transferring successful implementation strategies from research to practice requires approaches for assessing fidelity to the strategy’s core components. Implementation facilitation (IF) is a strategy involving an interactive process of problem-solving, enabling, and supporting individuals in efforts to implement clinical innovations that occurs in the context of a recognized need for improvement and supportive interpersonal relationships. Because IF is a dynamic strategy involving numerous activities, our objective was to conduct a rigorous consensus development process to identify core activities for monitoring fidelity to IF when applied in clinical settings. We first conducted a scoping literature review to identify the range of activities used when IF has been applied in clinical settings, searching multiple citation databases for English-language articles including “facilitation” or other commonly-used terms for the strategy published from 1996–2015. Through multi-stage screening, 135 articles (from 94 studies) were identified for data extraction on IF activities, frequency with which IF activities were identified as ‘core’ by study authors, and study outcomes. From the literature review, we identified 32 distinct IF activities and developed definitions/examples for each. Next, we conducted a 3-stage, modified-Delphi expert panel consensus development process to identify core IF activities across three implementation phases (i.e., Pre-Implementation, Implementation, Sustainment). The expert panel identified 8 core activities for the Pre-Implementation Phase, 8 core activities for the Implementation Phase, and 4 core activities for the Sustainment Phase. This work provides an important foundation for developing measures/tools to assess use of core IF activities to ensure the strategy is delivered with fidelity.

A literature review and expert consensus statement on diagnostics in suspected metal implant allergy.

Although rare, allergic reactions to metal implants represent a diagnostic challenge in view of missing guidelines. To develop an European expert consensus on characteristics of metal allergy reactions and the utility of various diagnostic tools in suspected metal implant allergy. A nominal group technique (NGT) was applied to develop consensus statements. Initially an online literature database was created on a secure server to enable a comprehensive information. Twenty-three statements were formulated on potential aspects of metal implant allergy with a focus on diagnostics and grouped into five domains. For the consensus development, the panel of 12 experts initially did refine and reformulate those statements that were ambiguous or had unclear wording. By face-to-face (9/12) or virtual participation (3/12), an anonymous online voting was performed. Consensus (≥80% of agreement) was reached in 20/23 statements. The panel agreed that implant allergy despite being rare should be considered in case of persistent unexplained symptoms. It was, however, recommended to allow adequate time for resolution of symptoms associated with healing and integration of an implant. Obtaining questionnaire-aided standardized medical history and standardized scoring of patient outcomes was also considered an important step by all experts There was broad consensus regarding the utility/performance of patch testing with additional late reading. It was recognized that the lymphocyte transformation test (LTT) has to many limitations to be generally recommended. Prior to orthopaedic implant, allergy screening of patients without a history of potential allergy to implant components was not recommended. Using an expert consensus process, statements concerning allergy diagnostics in suspected metal implant allergy were created. Areas of nonconsensus were identified, stressing uncertainty among the experts around topics such as preoperative testing in assumed allergy, histological correlate of periimplant allergy and invitro testing, which underscores the need for further research.