Final Consensus Research Articles

Best Practices for Delivering Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma

Neoadjuvant therapy (NT) is an increasingly used treatment strategy for patients with localized pancreatic ductal adenocarcinoma (PDAC). Little research has been conducted on cancer care delivery during NT, and the standards for optimal delivery of NT have not been defined. To develop consensus best practices for delivering NT to patients with localized PDAC. This study used a modified Delphi approach consisting of 2 rounds of voting, and a series of virtual conferences (from October to December 2023) to reach expert consensus on candidate best practice statements generated from a systematic review of the literature and expert opinion. An interdisciplinary panel was formed including 47 North American experts from surgical, medical, and radiation oncology, radiology, pathology, gastroenterology, integrative oncology, anesthesia, pharmacy, nursing, cancer care delivery research, and nutrition as well as patient and caregiver stakeholders. Statements that reached 75% agreement or greater were included in final consensus statements. Of the 47 participating panel members, 27 (57.64%) were male, and the mean (SD) age was 47.6 (8.2) years. Physicians reported completing training a mean (SD) 14.6 (8.6) years prior and seeing a mean (SD) 110.6 (38.4) patients with PDAC annually; 35 (77.7%) were in academic practice. Final consensus was reached on 82 best practices for delivering NT. Of these, 38 statements focused on pre-NT practices, including diagnosis and staging (n = 15), evaluation and optimization (n = 20), and decision-making (n = 3); 29 statements defined best practices during NT, including initiation (n = 3), delivery of therapy (n = 8), restaging practices (n = 12), and management of complications during NT (n = 6); and 15 best practices were identified to guide treatment post-NT, focusing on surgery (n = 7), pathology (n = 4), and follow-up (n = 3). Using a modified Delphi consensus technique, best practice guidelines were developed focusing on the optimal standards for delivering NT to patients with localized PDAC. Given the prognostic importance of completing multimodality therapy, efforts to standardize and optimize the delivery of NT represent an immediate opportunity to decrease care variation and improve outcomes for patients with PDAC. Future research should focus on validating and implementing best practice standards into clinical practice.

Development of a core outcome set for psychological therapy trials on acute psychiatric inpatient wards

BackgroundConsensus on what outcomes should be included in trials of psychological therapies on acute psychiatric inpatient wards is currently lacking. Inclusion of different viewpoints, including service user perspectives, is crucial in ensuring that future trials measure outcomes which are meaningful and important. Development of a Core Outcome Set (COS), a minimum standardised set of outcomes to be measured and reported, would help improve synthesis and interpretation of clinical trial data in this area.MethodsStage 1 of the COS development involved compiling a comprehensive long-list of outcomes from key sources including i) a systematic review of outcomes from published trials, ii) online survey of key stakeholders (service users, carers, healthcare professionals, researchers, and end users of research), iii) qualitative interviews with service users and carers. Stage 2 involved stakeholder groups short-listing the outcomes using consensus methods (e-Delphi survey). The final outcome set was derived from the short-list at a consensus meeting of stakeholders, facilitated by an Independent Chair.ResultsA long-list of 68 outcomes was compiled from the systematic review (n = 30 trials), online stakeholder survey (n = 100 participants) and qualitative interviews (n = 15 participants). Fifty stakeholders took part in the e-Delphi study, where the long-list was cut down to a short-list of 12 outcomes over 2 rounds. Nine stakeholders took part in the final consensus meeting, and after some outcomes were removed and/or amalgamated, a final set of 6 outcomes was recommended for inclusion in the COS. These were Ability to Cope, Hopefulness, Quality of Life, Psychosis Symptoms, Mood, and Self-Harm Behaviours.ConclusionsWidespread future adoption of the COS will reduce research waste by ensuring that outcomes are more easily comparable across trials, and that the full range of stakeholder priorities are represented in trial outcomes. This makes it more likely that effective therapies will be identified in a timely fashion and successfully implemented in routine clinical practice. The final 6-outcome COS should be feasible to implement given the need keep participant burden to a minimum in inpatient trials. Further work is needed to make recommendations for the best outcome measurement instruments to use, including the use of patient-reported outcomes alongside clinician-rated measures.Trial registrationNot applicable.

British Skull Base Society Consensus on Vestibular Schwannoma Surveillance

Abstract Objective Surveillance plays a crucial role in managing patients with vestibular schwannomas (VSs). Consensus is lacking on the optimal duration, frequency, and modality of imaging. Standardizing this approach would ensure safe and effective care, reduce patient distress, and promote consistency in management decisions among clinicians. Methods In July 2022, a multi-disciplinary Delphi consensus was conducted at the British Skull Base Society Meeting. Expert United Kingdom-based skull-base surgeons and neuroradiologists were presented semi-systematic literature reviews summarizing current evidence on VS management. Anonymized opinions were collated and discussed to reach a majority vote, which was deemed the final consensus opinion. Results Recommendations for VS managed by surveillance are: (1) surveillance frequency should decrease over time; (2) surveillance may be discontinued when the remaining lifetime risk of VS growth is <0.5% (∼8.5 years); (3) factors such as age, VS size, VS location, and cystic components should be considered. Surveillance after surgery or radiotherapy has limited evidence but recommendations are: (4) surveillance should be adjusted based on residual tumor size or nodular enhancement. Imaging modality and sequences are recommended to be (5) high-resolution magnetic resonance imaging with T1, T2, FIESTA/CISS multiplanar sequences, contrast is not required in untreated cases, and linear reporting of measurements is pragmatically sufficient. Conclusion This consensus and literature review provides an evidence and expert opinion–based guide to help clinicians with the surveillance of patients with VS. Further research should focus on better understanding the dynamic nature of growth risks and the growth characteristics of postintervention VS to enable personalized growth risk stratification.

Diagnostic approach to rickets: an Endocrine Society of Bengal (ESB) consensus statement.

Rickets, one of the leading causes of bony deformities and short stature, can be calciopenic (inciting event is defective intestinal calcium absorption) or phosphopenic (inciting event is phosphaturia). Early diagnosis and timely treatment of rickets are crucial for correction of the limb deformities. Guidelines exist for nutritional rickets, but the diagnosis and management of the relatively uncommon forms of rickets are complex. This consensus aims to formulate a simplified diagnostic approach for rickets, especially in resource-limited settings. The consensus statement has been formulated by a 29-member committee from the Endocrine Society of Bengal. The process included forming a working group, conducting a literature review, identifying controversies, drafting, and discussion at a consensus meeting. Participants rated their agreement with the clinical practice points, and a 70% consensus was required. Input integration and further review led to the final consensus statements. Children with suspected rickets should initially be examined for distinctive skeletal deformities. The diagnosis of rickets should be confirmed with characteristic radiographic abnormalities. It is advisable to order tests for serum calcium, inorganic phosphorus (Pi), liver function, 25-hydroxyvitamin D (25OHD), parathyroid hormone, creatinine, and potassium in all patients with rickets. In cases of refractory rickets, it is also recommended that assessments be conducted for spot urine calcium, Pi, creatinine, and, blood gas analysis. In children with rickets and metabolic acidosis, tests for glycosuria, uricosuria, aminoaciduria, low molecular weight proteinuria, and albuminuria should be conducted. In children with resistant calciopenic rickets and sufficient serum 25OHD levels, serum 1,25(OH)2D concentration should be tested. 1,25(OH)2 D and fibroblast growth factor 23 estimation is useful for certain forms of phosphopenic rickets.

Estimating weight for multidimensional health poverty using Delphi method and analytic hierarchy process: a case of China

BackgroundTraditionally, poverty assessment has relied on a single income criterion, which is inadequate in contexts where absolute poverty has been mitigated. This study developed a weighting scheme for the Multidimensional Health Poverty Index (MHPI) based on sustainable livelihood framework (SLF), aimed at enhancing the accuracy of poverty identification in China.MethodsA two-round Delphi process was used to determine the indicators of the index system. The weight of each indicator was calculated using the analytic hierarchy process (AHP) method. The multidimensional poverty index incorporates SLF’s five dimensions: financial, natural, physical, social, and human capital.ResultsThe initial 46 indicators formed an indicator pool for the Delphi questionnaire. Based on the final consensus of the expert panel, the Delphi consultation resulted in an index system comprising six first-level and 23 second-level indicators. The weight values of the first-level indicators (economic security, health status, education, social capital, healthcare utilisation, and living conditions) were 0.2715, 0.2593, 0.0855, 0.0657, 0.1812, and 0.1363, respectively.ConclusionThis study established a scientific and effective index to evaluate generate weight for estimating multidimensional health poverty in China. Economic security, health status, and healthcare utilisation are the most crucial aspects of multidimensional health poverty. Moreover, the results indicated that vocational training and social capital should be emphasised.

Expert Panel Consensus Recommendations for Allergic Rhinitis in Patients with Asthma in India.

Allergic rhinitis and asthma are commonly coexisting conditions, significantly impacting patient health and quality of life. Despite their interrelation, diagnosing allergic rhinitis in patients with asthma remains challenging, leading to underdiagnosis and suboptimal management. The expert consensus engaged a modified Delphi method involving 29 experts including pulmonologists, ear, nose, and throat surgeons, and allergologists. Through group discussions, consensus statements were developed regarding the epidemiology, diagnosis, and management of allergic rhinitis and asthma. Final consensus statements were formulated based on the experts' collective clinical judgment and experience. This expert consensus provides updated recommendations tailored to the Indian context, addressing the gaps in existing research and clinical practice. By promoting a systematic and evidence-based approach to diagnosis and management, this consensus aims to support clinicians in effectively identifying and treating allergic rhinitis in patients with asthma, thereby improving overall disease management and patient well-being.

Multi-kernel clustering with tensor fusion on Grassmann manifold for high-dimensional genomic data

The high dimensionality and noise challenges in genomic data make it difficult for traditional clustering methods. Existing multi-kernel clustering methods aim to improve the quality of the affinity matrix by learning a set of base kernels, thereby enhancing clustering performance. However, directly learning from the original base kernels presents challenges in handling errors and redundancies when dealing with high-dimensional data, and there is still a lack of feasible multi-kernel fusion strategies. To address these issues, we propose a Multi-Kernel Clustering method with Tensor fusion on Grassmann manifolds, called MKCTM. Specifically, we maximize the clustering consensus among base kernels by imposing tensor low-rank constraints to eliminate noise and redundancy. Unlike traditional kernel fusion approaches, our method fuses learned base kernels on the Grassmann manifold, resulting in a final consensus matrix for clustering. We integrate tensor learning and fusion processes into a unified optimization model and propose an effective iterative optimization algorithm for solving it. Experimental results on ten datasets, comparing against 12 popular baseline clustering methods, confirm the superiority of our approach. Our code is available at https://github.com/foureverfei/MKCTM.git.

COVID-19 Vaccination Recommendations for Immunocompromised Patient Populations: Delphi Panel and Consensus Statement Generation in the United States.

The United States Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control (CDC) recommend COVID-19 vaccines for all immunocompromised individuals. Certain disease groups are at increased risk of comorbidity and death for which disease-specific recommendations should be considered. The objective of the Delphi panel of experts was to summarize expert consensus on COVID-19 vaccinations for patients with rheumatologic disease, renal disease, hematologic malignancy and solid organ transplant (SOT) in the US. A two-stage Delphi panel method was employed, starting with qualitative interviews with key opinion leaders (KOLs) in the four disease areas (n = 4 KOLs, n = 16 total) followed by three rounds of iterative revision of disease-specific COVID-19 vaccine recommendations. Final consensus was rated after the third round. Statements addressed primary and booster dosing (e.g., number and frequency) and other considerations such as vaccine type or heterologous messenger ribonucleic acid (mRNA) vaccination. Following the Delphi Panel, an online survey was conducted to assess physician agreement within the disease areas (n = 50 each, n = 200 total) with the consensus statements. Moderate to strong consensus was achieved for all primary series vaccination statements across disease groups, except one in hematology. Similarly, moderate to strong consensus was achieved for all booster series statements in all disease areas. However, statements on antibody titer measurements for re-vaccination considerations and higher dosages for immunocompromised patients did not reach agreement. Overall, approximately 62%-96% of physicians strongly agreed with the primary and booster vaccine recommendations. However, low agreement (29%-69%) was found among physicians for time interval between disease-specific treatment and vaccination, recommendations for mRNA vaccines, heterologous mRNA vaccination, antibody titer measurement and higher vaccine dosage for immunocompromised groups. Consensus was achieved for disease-specific COVID-19 vaccine recommendations concerning primary and booster series vaccines and was generally well accepted by practicing physicians.

7234 Creation Of The Minimum Dataset Required For Monitoring The Safety And Efficacy of Growth Hormone Therapy in Children with Noonan Syndrome - A GloBE-Reg Initiative

Abstract Disclosure: S. Chen: Research Investigator; Self; Pfizer, Inc.. J. Bryce: None. M. Chen: None. G. Binder: Advisory Board Member; Self; Ascendis, Ferring Pharmaceuticals, Ipsen, Novo Nordisk, Pfizer, Inc., Sandoz. Grant Recipient; Self; Novo Nordisk. Speaker; Self; Ferring Pharmaceuticals, Ipsen, Lilly USA, LLC, Merck, Novo Nordisk, Pfizer, Inc., Sandoz. C.S. Choong: None. T. Edouard: Advisory Board Member; Self; Biomarin, Novo Nordisk. Speaker; Self; Biomarin, Novo Nordisk. A. Fu: None. R. Horikawa: None. A. Hubbard: None. J. Lebl: Speaker; Self; Pfizer, Inc., Novo Nordisk, Merck. L. Mazzanti: Speaker; Self; Novo Nordisk, Pfizer, Inc., Sandoz. A. Romano: Consulting Fee; Self; Novo Nordisk. Speaker; Self; Novo Nordisk. M. Shaikh: Consulting Fee; Self; Novo Nordisk, Pfizer, Inc.. F. Tamburrino: None. S. Tamponi: None. P. Yger: None. S. Ahmed: Grant Recipient; Self; Novo Nordisk, Pfizer, Inc., GenSci. Speaker; Self; Ipsen. A. Jorge: Grant Recipient; Self; Biomarin. Research Investigator; Self; Novo Nordisk. Speaker; Self; Novo Nordisk, Pfizer, Inc. Introduction: Recombinant human growth hormone (rhGH) is approved internationally for use in Noonan syndrome (NS); initially by the FDA in 2007 and most recently in Europe in 2020. Most studies have shown benefit in linear growth and adult height associated with rhGH therapy, although response to treatment often varies, and longer-term safety data is limited. Moreover, comparisons between studies are compromised by the lack of consistency in data collection. The objective of the current study was to identify the minimum dataset (MDS) that could be monitored and reported globally in a routine clinical setting. Methods: This study was undertaken by the NS Expert Working Group in GloBE-Reg, the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (https://globe-reg.net/). Ten international clinical experts in NS from ten different countries and three patient representatives of patient organisations collaborated to develop this recommendation, based on a previously described and published methodology for the grading system to determine if an item fulfils the criteria for the MDS rhGH in childhood onset GH deficiency (GHD) (doi: 10.1159/000533763). Data fields that achieved >70% consensus in terms of importance qualified for the MDS, provided <50% of the group deemed the item difficult to collect. Results: Preparation for the development of the finalised MDS occurred over 4 months, including two teleconference meetings between the group members and a final consensus meeting also held virtually. A total of 256 items were compiled and 9 removed for redundancies, with 247 items subjected to the grading system. Of these, 169 items achieved at least 70% consensus as important data to collect and a total of 169, albeit different items, were deemed easy to collect when monitoring children with NS on rhGH. Combining the criteria of importance and ease of data collection, 124 fulfilled the criteria for the MDS. Six items were designated as core data, 2 were computed fields, 10 items were removed following detailed discussion and 48 items were merged, to produce the final MDS recommendation of 57 items which consisted of 20 items that were only required to be completed once, and the rest at least once annually. Importantly, the exercise also showed that the MDS for monitoring of safety and efficacy of rhGH therapy differs for the different licensed indications for rhGH use, as the need for growth hormone stimulation tests and information on reinitiation after final adult height was not included in the NS MDS in contrast to the MDS for GHD. Conclusion: In summary, this exercise performed through the GloBE-Reg initiative provides a recommendation of the MDS requirement that should be collected as part of routine clinical practice, for the reporting of core outcomes that relate to safety and effectiveness of all forms of rhGH in children with NS. Presentation: 6/3/2024

Delphi-driven consensus definition for mesenchymal stromal cells and clinical reporting guidelines for mesenchymal stromal cell–based therapeutics

Background aimsDespite promising results in pre-clinical studies, mesenchymal stromal cells (MSCs) face significant challenges in clinical translation. A scoping review by our group highlighted two key issues contributing to this gap: (i) lack of a clear and consensus definition for MSCs and (ii) under-reporting of critical parameters in MSC clinical studies. To address these issues, we conducted a modified Delphi study to establish and implement a consensus definition for MSCs and develop reporting guidelines for MSC clinical studies. MethodsA steering committee of 22 international experts, including stakeholders from different MSC research fields, participated in the three Delphi rounds. For the first round, to obtain a broad perspective, additional investigators recommended by the steering committee were invited to participate. The first two rounds consisted of online surveys, whereas the third round took the form of a virtual meeting. Participants were asked to rate a series of potential defining characteristics of MSCs and items for reporting guidelines. Consensus was defined as at least 80% of the participants rating the item in the same category of importance. ResultsEighty-seven international participants participated in the first round survey (spring 2023), 17 participants participated in the second online survey (fall 2023) and 15 participants participated in the final virtual consensus meeting (January 2024). For the MSC definition, 20 items were considered and nine reached consensus. Items included terminology (one item), cell marker expression (five items), tissue origin (one item), stemness (one item) and description of critical quality attributes (one item). For the reporting guidelines, with the 28 initial items and the additional items suggested during round 1, a total of 33 items to report were included. This included items on MSC intervention group and control (e.g., MSC product, dose and administration), MSC characteristics (e.g., MSC provenance, “fitness,” viability and immune compatibility) and MSC culture conditions (e.g., oxygen environment, culture medium and use of serum). ConclusionsBy applying a Delphi method to establish a consensus definition for MSCs and reporting guidelines for MSC-based clinical trials, this work represents a significant advance in improving transparency and reproducibility in the conduct and reporting of MSC research.

A Consensus on Staphylococcus aureus Exacerbated Atopic Dermatitis and the Need for a Novel Treatment.

The skin microbiome is essential for skin barrier function because it inhibits pathogen colonization, and decreased microbiome diversity correlates with increased Staphylococcus aureus (S. aureus) burden and atopic dermatitis (AD) severity. Managing S. aureuss-driven AD in clinical practice remains problematic due to complications such as AD exacerbation, impetigo, abscesses, and invasive infections. This project used a modified Delphi process comprising face-to-face discussions followed by a blinded vote to define 5 final consensus statements. A panel of 6 pediatric dermatologists developed a consensus on S. aureus-driven AD exacerbation, challenges in current treatments for AD with secondary bacterial infections, and new developments to improve patient care and outcomes. The panel's 5 consensus statements provide recommendations for dermatologists, pediatricians, and healthcare providers treating patients with secondary infected AD. These recommendations underscore the importance of recognizing and managing S. aureus skin infection in AD clinical practice and promoting antibiotic stewardship to mitigate resistance. The panel defined a significant unmet need for a single topical AD therapy effective against all symptoms, including pruritus, S. aureus-driven AD exacerbation, infection, and inflammation, across AD severity levels. J Drugs Dermatol. 2024;23(10):825-832. doi:10.36849/JDD.8240.

The management of idiopathic toe walking.

The aim of this study was to gain a consensus for best practice of the assessment and management of children with idiopathic toe walking (ITW) in order to provide a benchmark for practitioners and guide the best consistent care. An established Delphi approach with predetermined steps and degree of agreement based on a standardized protocol was used to determine consensus. The steering group members and Delphi survey participants included members from the British Society of Children's Orthopaedic Surgery (BSCOS) and the Association of Paediatric Chartered Physiotherapists (APCP). The statements included definition, assessment, treatment indications, nonoperative and operative interventions, and outcomes. Descriptive statistics were used for analysis of the Delphi survey results. The AGREE checklist was followed for reporting the results. A total of 227 participants (54% APCP and 46% BSCOS members) completed the first round, and 222 participants (98%) completed the second round. Out of 54 proposed statements included in the first round Delphi, 17 reached 'consensus in', no statements reached 'consensus out', and 37 reached 'no consensus'. These 37 statements were then discussed, reworded, amalgamated, or deleted before the second round Delphi of 29 statements. A total of 12 statements reached 'consensus in', four 'consensus out', and 13 'no consensus'. In the final consensus meeting, 13 statements were voted upon. Five were accepted, resulting in a total of 31 approved statements. In the aspects of practice where sufficient evidence is not available, a consensus statement can provide a strong body of opinion that acts as a benchmark for excellence in clinical care. This statement can assist clinicians managing children with ITW to ensure consistent and reliable practice, and reduce geographical variability in practice and outcomes. It will enable those treating ITW to share the published consensus document with both carers and patient groups.

Medicación pediátrica de alto riesgo: propuesta de listado a través de la técnica de consenso interdisciplinar

IntroductionPediatric patients are more likely to experience medication-related errors and serious associated harms. The identification of high-risk medications (HRM) and their study in special populations, such as children with excess body weight, is a part of safety improvement strategies. ObjectiveTo generate, through a consensus technique structured by an interdisciplinary group of pediatricians and hospital pharmacists, an operational and updated list of HRM for hospital use in children over 2 years of age. The document was part of a collaboration project between the Spanish Society of Hospital Pharmacists and the Spanish Society of Pediatric Hospital Medicine. MethodsThe study was carried out in two sequential phases: a) preparation of a preliminary list of HRM through bibliographic review and b) subsequent application of the double-round Delphi method to agree on a definitive list of HRM. The results obtained were validated by calculating the probability of chance agreement and the modified Kappa statistic for each drug. ResultsThe original list obtained by bibliographic review included 26 pharmacological classes and 96 drugs. Of the total of 37 experts, 32 (86.4%) completed both rounds of the Delphi. The final consensus list of HRM incorporated 24 pharmacological classes and 100 drugs. The modified Kappa statistic reflected a high percent agreement (94.9%) in the consensus reached by the participants. ConclusionThis list can establish a tool for future studies and interventions to improve the safety of medications in general pediatric population, as well as in high-risk subgroups, such as pediatric patients with excess body weight.

Identifying the content of the Lower Extremity Motor Activity Log based on the International Classification of Functioning, Disability and Health

Purpose To identify the content and the constructs measured in the Lower Extremity Motor Activity Log (LE-MAL) based on the International Classification of Functioning, Disability and Health (ICF) framework and to determine whether the instrument items fit within the ICF mobility domain. Methods Concepts and constructs measured within each scale were linked to the best-matched ICF categories and classified using established linking rules. Two independent researchers determined the initial linkages. A final consensus was reached with the other researchers. The agreement was analysed through the agreement percentage and the kappa coefficient. Results The subscales assess performance through information about need or dependency, personal and environmental factors, and appraisal of the items. Thirteen concepts were identified in LE-MAL: two concepts for the Assistance Scale are covered in the environmental factors component; 10 concepts for the Functional Performance Scale where all items are covered in the mobility domain; one concept for the confidence scale is covered in the body functions component. Conclusions The general construct of LE-MAL assessed is performance in the ICF mobility domain and provides additional information about the mental function, environmental factors, independence, appraisal, and personal factors. The study highlighted the conceptual connection between the LE-MAL and the ICF framework.

KECORT Study: An International e-Delphi Study on the Treatment of KEloids Using Intralesional CORTicosteroids in Clinical Practice.

Intralesional corticosteroid administration (ICA) is a first-line keloid treatment. However, it faces significant variability in current clinical and scientific practice, which hinders comparability of treatment results. The aim of the study was to reach consensus on different aspects of ICA using hypodermic needles in keloids among an international group of dermatologists and plastic surgeons specialized in keloid treatment to provide consensus-based clinical treatment recommendations for all physicians treating keloids. The keloid expert panel of 12 dermatologists and 11 plastic surgeons rated 30 statements. Two online e-Delphi rounds were held, both with a response rate of 100%. Fifteen (65%) keloid experts participated in the final consensus meetings. Consensus was defined as ≥ 75% of the participants choosing agree or strongly agree on a 7-point Likert scale. Consensus was reached on treatment goals, indication for ICA, triamcinolone acetonide (TAC) 40 mg/mL as the preferred corticosteroid administered at a maximum of 80 mg per month and at intervals of 4 weeks, minimizing pain during ICA, the use of 1 mL syringes and 25 or 27 Gauge needles, blanching as endpoint of successful infiltration, caution of not injecting subcutaneously, and the option of making multiple passes in very firm keloids prior to infiltration. Consensus could not be reached on TAC dosing, methods of prior local anesthesia, and location of injection. This e-Delphi study provides important clinical treatment recommendations on essential aspects of ICA in keloids. By implementing these recommendations, uniformity of ICA in keloid treatment will increase and better treatment results may be achieved.

Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies Using AI (QUADAS-AI): Protocol for a Qualitative Study.

Quality assessment of diagnostic accuracy studies (QUADAS), and more recently QUADAS-2, were developed to aid the evaluation of methodological quality within primary diagnostic accuracy studies. However, its current form, QUADAS-2 does not address the unique considerations raised by artificial intelligence (AI)-centered diagnostic systems. The rapid progression of the AI diagnostics field mandates suitable quality assessment tools to determine the risk of bias and applicability, and subsequently evaluate translational potential for clinical practice. We aim to develop an AI-specific QUADAS (QUADAS-AI) tool that addresses the specific challenges associated with the appraisal of AI diagnostic accuracy studies. This paper describes the processes and methods that will be used to develop QUADAS-AI. The development of QUADAS-AI can be distilled into 3 broad stages. Stage 1-a project organization phase had been undertaken, during which a project team and a steering committee were established. The steering committee consists of a panel of international experts representing diverse stakeholder groups. Following this, the scope of the project was finalized. Stage 2-an item generation process will be completed following (1) a mapping review, (2) a meta-research study, (3) a scoping survey of international experts, and (4) a patient and public involvement and engagement exercise. Candidate items will then be put forward to the international Delphi panel to achieve consensus for inclusion in the revised tool. A modified Delphi consensus methodology involving multiple online rounds and a final consensus meeting will be carried out to refine the tool, following which the initial QUADAS-AI tool will be drafted. A piloting phase will be carried out to identify components that are considered to be either ambiguous or missing. Stage 3-once the steering committee has finalized the QUADAS-AI tool, specific dissemination strategies will be aimed toward academic, policy, regulatory, industry, and public stakeholders, respectively. As of July 2024, the project organization phase, as well as the mapping review and meta-research study, have been completed. We aim to complete the item generation, including the Delphi consensus, and finalize the tool by the end of 2024. Therefore, QUADAS-AI will be able to provide a consensus-derived platform upon which stakeholders may systematically appraise the methodological quality associated with AI diagnostic accuracy studies by the beginning of 2025. AI-driven systems comprise an increasingly significant proportion of research in clinical diagnostics. Through this process, QUADAS-AI will aid the evaluation of studies in this domain in order to identify bias and applicability concerns. As such, QUADAS-AI may form a key part of clinical, governmental, and regulatory evaluation frameworks for AI diagnostic systems globally. DERR1-10.2196/58202.

Disease activity score for still's disease.

To develop the Still's Disease Activity Score (SDAS). We used data from the prospective adult-onset Still's disease cohort study and evaluated the disease activity. An expert group selected the most frequent, reproducible, and objective variables significantly modified in statistical analysis when comparing patients in the active group and in the remission group. These criteria were weighted to design the Still's Disease Activity Score (SDAS). The Delphi method was used to appreciate the level of disease activity. Total SDAS was calculated for each patient and compared to final consensus experts. At the diagnosis, all patients had an active disease (n = 80), while 48 patients were in remission at 6 months. The SDAS criteria were weighted as follows: fever ≥ 38.5 °C (1 point), rash (1 point), joint involvement (arthralgia: 1 point, swollen joints count "SJC": 1-3 SJC: 2 points, ≥ 4 SJC: 3 points), physician global assessment VAS ≥ 5/10 or a raise in physician VAS ≥ 2/10 (3 points), patient VAS ≥ 5 or a raise in patient VAS ≥ 2/10 (1 point), and CRP (> 10 mg/l: 1 point, ≥ 100 mg/l: 2 points). At 6 months, the consensus was achieved for 76 (95%) patients with 40 in remission (0-1 point), 8 in low disease activity (2-3 points), 16 in moderate disease activity (4-7 points), and 12 in severe disease activity (≥ 8 points). The Still's Disease Activity Score is a valid and sensitive assessment of the disease activity and the therapeutic response in Still's disease, despite its heterogeneous manifestations and patterns with systemic and articular forms. Key Points •The Still's Disease Activity Score (SDAS) is a good simple tool to assess the activity of the disease in a stable state for a week. •The SDAS is developed specifically for Still's disease without the need for an application or a calculator to calculate SDAS in routine clinical practice. •SDAS is a composite score classifying the disease activity in remission, low disease activity, moderate disease activity, and severe disease activity despite its heterogeneous patterns (systemic and articular forms). •The SDAS is a valid, reliable, and sensitive score and can be useful to guide the therapeutic strategy in clinical practice and in research.

Interpretation of the expert consensus of the British Association for Surgery of the Knee (BASK) and the European Knee Society (EKS) on unicompartmental knee arthroplasty

Unicompartmental knee arthroplasty (UKA) has a long history and has many advantages in some aspects over total knee arthroplasty (TKA) for patients with suitable indications, but it has not been established as a treatment at the same level with TKA. Therefore, 80 members of the British Association for Surgery of the Knee (BASK) and the European Knee Society (EKS) were invited to attend a joint meeting with the aim of creating an evidence-based consensus statement on UKA, in London, UK (December 2019). A formal consensus process was undertaken at the meeting incorporating a multiple round Delphi exercise, with group discussion of areas of agreement and disagreement between rounds. Five consensus statements were issued: ① UKA should be offered as a successful alternative to TKA in patients undergoing arthroplasty who meet agreed indications. ② When consenting a patient for UKA, information including the benefits and risks that are specific to UKA, should be tailored to and discussed with the individual patient. ③ Evidence suggests that surgeons should avoid low-volume use of UKA to optimise outcomes for their patients. ④ Surgeons should use the contemporary evidence-based indications and contraindications for medial UKA. ⑤ Knee arthroplasty surgeons should have exposure to and training in UKA. On the basis of full study of the consensus, combined with the Expert Consensus on Perioperative Management of Unicompartmental Knee Arthroplasty in China in 2020, this paper elaborates the meaning of the final evidence-based consensus for clinicians' reference.

Codesign of a Quality Improvement Tool for Adults With Prolonged Critical Illness: A Modified Delphi Consensus Study.

Increasing numbers of patients experience a prolonged stay in intensive care. Yet existing quality improvement (QI) tools used to improve safety and standardize care are not designed for their specific needs. This may result in missed opportunities for care and contribute to worse outcomes. Following an experience-based codesign process, our objective was to build consensus on the most important actionable processes of care for inclusion in a QI tool for adults with prolonged critical illness. Items were identified from a previous systematic review and interviews with former patients, their care partners, and clinicians. Two rounds of an online modified Delphi survey were undertaken, and participants were asked to rate each item from 1 to 9 in terms of importance for effective care; where 1-3 was not important, 4-6 was important but not critical, and 7-9 was critically important for inclusion in the QI tool. A final consensus meeting was then moderated by an independent facilitator to further discuss and prioritize items. Carried out in the United Kingdom. Former patients who experienced a stay of over 7 days in intensive care, their family members and ICU staff. None. We recruited 116 participants: 63 healthcare professionals (54%), 45 patients (39%), and eight relatives (7%), to Delphi round 1, and retained 91 (78%) in round 2. Of the 39 items initially identified, 32 were voted "critically important" for inclusion in the QI tool by more than 70% of Delphi participants. These were prioritized further in a consensus meeting with 15 ICU clinicians, four former patients and one family member, and the final QI tool contains 25 items, including promoting patient and family involvement in decisions, providing continuity of care, and structured ventilator weaning and rehabilitation. Using experience-based codesign and rigorous consensus-building methods we identified important content for a QI tool for adults with prolonged critical illness. Work is underway to understand tool acceptability and optimum implementation strategies.

Diagnosis and management of pediatric acute liver failure: consensus recommendations of the Indian Society of Pediatric Gastroenterology, Hepatology, and Nutrition (ISPGHAN).

Timely diagnosis and management of pediatric acute liver failure (PALF) is of paramount importance to improve survival. The Indian Society of Pediatric Gastroenterology, Hepatology, and Nutrition invited national and international experts to identify and review important management and research questions. These covered the definition, age appropriate stepwise workup for the etiology, non-invasive diagnosis and management of cerebral edema, prognostic scores, criteria for listing for liver transplantation (LT) and bridging therapies in PALF. Statements and recommendations based on evidences assessed using the modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) system were developed, deliberated and critically reappraised by circulation. The final consensus recommendations along with relevant published background information are presented here. We expect that these recommendations would be followed by the pediatric and adult medical fraternity to improve the outcomes of PALF patients.