Delphi Approach Research Articles

Consensus reporting guidelines to address gaps in descriptions of ultra-rare genetic conditions

Genome-wide sequencing and genetic matchmaker services are propelling a new era of genotype-driven ascertainment of novel genetic conditions. The degree to which reported phenotype data in discovery-focused studies address informational priorities for clinicians and families is unclear. We identified reports published from 2017 to 2021 in 10 genetics journals of novel Mendelian disorders. We adjudicated the quality and detail of the phenotype data via 46 questions pertaining to six priority domains: (I) Development, cognition, and mental health; (II) Feeding and growth; (III) Medication use and treatment history; (IV) Pain, sleep, and quality of life; (V) Adulthood; and (VI) Epilepsy. For a subset of articles, all subsequent published follow-up case descriptions were identified and assessed in a similar manner. A modified Delphi approach was used to develop consensus reporting guidelines, with input from content experts across four countries. In total, 200 of 3243 screened publications met inclusion criteria. Relevant phenotypic details across each of the 6 domains were rated superficial or deficient in >87% of papers. For example, less than 10% of publications provided details regarding neuropsychiatric diagnoses and “behavioural issues”, or about the type/nature of feeding problems. Follow-up reports (n = 95) rarely contributed this additional phenotype data. In summary, phenotype information relevant to clinical management, genetic counselling, and the stated priorities of patients and families is lacking for many newly described genetic diseases. The PHELIX (PHEnotype LIsting fiX) reporting guideline checklists were developed to improve phenotype reporting in the genomic era.

Development of a Lean and Green Indicators for Sustainability Assessment in Processing Manufacturing Industries: A Delphi approach

Sustainability has become a concern of academics and practitioners, where implementing sustainability can help reduce environmental impact, and for that, it is necessary to take steps to assess the level of sustainability. So to assess sustainability, it is necessary to discuss the indicators used to measure sustainability, where these indicators really need to be discussed in measuring sustainability manufacture. This paper aims to determine the selection of indicators used for sustainability assessment in the manufacturing industry by discussing lean and green indicators to measure sustainability. Given that lean focuses on operational performance while green focuses on environmental performance, these two dimensions will be examined for appropriate indicators to measure sustainability. The Delphi method is used in this study to select manufacturing sustainability indicators that are appropriate or relevant to the manufacturing industry. The findings of this study found 29 indicators suitable for measuring sustainability in the processing manufacturing industry, consisting of 13 indicators for the economic dimension, 9 for the environmental dimension, and 7 for the social dimension. The indicators obtained can be applied to measure sustainability in the cooking oil processing manufacturing industry.

Assessment of Critical Project Success Factors for Management of Pavement Construction Using the Delphi Approach

Assessment of Critical Project Success Factors for Management of Pavement Construction Using the Delphi Approach

Development of a bronchopulmonary dysplasia nutrition focused physical examination tool: A modified Delphi study.

The objectives of this study were to identify factors impacting nutrition needs in infants and children with bronchopulmonary dysplasia (BPD). A modified Delphi approach to obtain consensus among pediatric registered dietitian nutritionists (RDNs) was used to create a BPD-specific nutrition focused physical examination (NFPE) tool. RDNs, recruited through pediatric nutrition professional associations, completed a survey rating proposed NFPE components on a Likert scale of 1-5 allowing open-ended responses in a two-round Delphi. Responses were analyzed, deidentified, and results were returned to panelists for in-round feedback. Consensus was defined a priori as 75% agreement for usefulness or relevance ± 1 standard deviation. Six domains (anthropometrics, body composition, development, gastrointestinal, respiratory, and physical signs) and 38 components achieved consensus. Components for an evidence-based tool to enhance nutrition assessment in infants and children with BPD were identified with consensus agreement by an expert panel of 19 pediatric RDNs.

Identifying the perceptions, barriers, and implementation of middle school supervised agricultural experiences

Although School based agricultural education (SBAE) teachers have a variety or responsibilities within a comprehensive program, supervised agricultural experience (SAE) programs are considered an intracurricular component. Unfortunately, the ability for teachers to plan for and facilitate SAEs has been reported as lacking. The purpose of this study was to identify the current perceptions, barriers, and implementation of current middle school SAEs in the Southeast United States, which was carried out by a modified Delphi approach to reach consensus on the perceptions, barriers, and implementation of middle school SAEs from a panel of experts. After three rounds, 18 items achieved consensus related to perceptions of Middle School SAE integration, 19 items outlining barriers for Middle School SAE implementation, and 22 items indicating best practices for Middle School SAE integration. When we consider the uniqueness of middle school SBAE programs, the overall list of perceptions, barriers, and best practices is of great value for future implementation as additional programs are added. Recommendations for practice begin with purposeful professional development opportunities specific for middle school SBAE teachers.

American Rhinologic Society expert practice statement part 1: Skull base reconstruction following endoscopic skull base surgery.

The goal of this American Rhinologic Society expert practice statement (EPS) is to summarize the best available evidence for technical factors that optimize outcomes in skull base reconstruction following endoscopic skull base surgery for intradural pathologies. These topics include the use of free mucosal grafts versus vascularized pedicled nasoseptal flaps; the use of autologous versus synthetic grafts; and the roles of lumbar drains, dural sealants, and nasal packing. This EPS was developed following the recommended methodology and approval process as previously outlined. As there are a myriad of techniques and limited agreement on the accepted principles of skull base reconstruction, this EPS aims to summarize the existing evidence and provide clinically meaningful guidance on these divergent practices. Following a modified Delphi approach, five statements were developed, four of which reached consensus and one of which reached near consensus. These statements and the accompanying evidence are summarized along with an assessment of future needs.

Expert consensus recommendations for improving and standardising the assessment of patients with generalised myasthenia gravis.

Regular and consistent disease assessment could provide a clearer picture of burden in generalised myasthenia gravis (gMG) and improve patient care; however, the use of assessment tools in practice lacks standardisation. This modified Delphi approach was taken to review current evidence on assessment tool use in gMG and develop expert-derived consensus recommendations for good practice. A European expert panel of 15 experienced gMG neurologists contributed to development of this consensus, four of whom formed a lead Sub-committee. The PICO (Population, Intervention, Control, Outcomes) framework was used to define six clinical questions on gMG assessment tools, a systematic literature review was conducted, and evidence-based statements were developed. According to a modified Delphi voting process, consensus was reached when ≥70% of the experts rated agreement with a statement as ≥8 on a scale of 1-10. Eighteen expert- and evidence-based consensus statements based on six themes were developed. Key recommendations include: consistent use of the Myasthenia Gravis Activities of Daily Living score (MG-ADL) across clinical settings, followed by a simple question (e.g., Patient Acceptable Symptom State [PASS]) or scale to determine patient satisfaction in clinical practice; use of a Quantitative Myasthenia Gravis [QMG] or quality of life [QoL] assessment when the MG-ADL indicates disease worsening; and consideration of symptom state to determine the timing and frequency of recommended assessments. Expert panel consensus was reached on all 18 statements after two voting rounds. This process provided evidence- and expert consensus-based recommendations for the use of objective and subjective assessment tools across gMG research and care to improve management and outcomes for patients.

Implementing and Evaluating a National Integrated Digital Registry and Clinical Decision Support System in Early Intervention in Psychosis Services (Early Psychosis Informatics Into Care): Co-Designed Protocol.

Early intervention in psychosis (EIP) services are nationally mandated in England to provide multidisciplinary care to people experiencing first-episode psychosis, which disproportionately affects deprived and ethnic minority youth. Quality of service provision varies by region, and people from historically underserved populations have unequal access. In other disease areas, including stroke and dementia, national digital registries coupled with clinical decision support systems (CDSSs) have revolutionized the delivery of equitable, evidence-based interventions to transform patient outcomes and reduce population-level disparities in care. Given psychosis is ranked the third most burdensome mental health condition by the World Health Organization, it is essential that we achieve the same parity of health improvements. This paper reports the protocol for the program development phase of this study, in which we aimed to co-design and produce an evidence-based, stakeholder-informed framework for the building, implementation, piloting, and evaluation of a national integrated digital registry and CDSS for psychosis, known as EPICare (Early Psychosis Informatics into Care). We conducted 3 concurrent work packages, with reciprocal knowledge exchange between each. In work package 1, using a participatory co-design framework, key stakeholders (clinicians, academics, policy makers, and patient and public contributors) engaged in 4 workshops to review, refine, and identify a core set of essential and desirable measures and features of the EPICare registry and CDSS. Using a modified Delphi approach, we then developed a consensus of data priorities. In work package 2, we collaborated with National Health Service (NHS) informatics teams to identify relevant data currently captured in electronic health records, understand data retrieval methods, and design the software architecture and data model to inform future implementation. In work package 3, observations of stakeholder workshops and individual interviews with representative stakeholders (n=10) were subject to interpretative qualitative analysis, guided by normalization process theory, to identify factors likely to influence the adoption and implementation of EPICare into routine practice. Stage 1 of the EPICare study took place between December 2021 and September 2022. The next steps include stage 2 building, piloting, implementation, and evaluation of EPICare in 5 demonstrator NHS Trusts serving underserved and diverse populations with substantial need for EIP care in England. If successful, this will be followed by stage 3, in which we will seek NHS adoption of EPICare for rollout to all EIP services in England. By establishing a multistakeholder network and engaging them in an iterative co-design process, we have identified essential and desirable elements of the EPICare registry and CDSS; proactively identified and minimized potential challenges and barriers to uptake and implementation; and addressed key questions related to informatics architecture, infrastructure, governance, and integration in diverse NHS Trusts, enabling us to proceed with the building, piloting, implementation, and evaluation of EPICare. DERR1-10.2196/50177.

Evaluation of sustainable development capacity of water sources: a case study of China.

The issue of water scarcity has drawn attention from all over the world. The coordination of the interaction between ecological and environmental development of water sources and socio-economic development is currently an essential issue that needs to be solved in order to safeguard the water resources environment for human survival. In this essay, we suggest a paradigm for assessing the sustainable exploitation of water resources. First, three ecological, economic, and social factors are investigated. Twenty essential evaluation indexes are then constructed using the Delphi approach, along with an index system for assessing the potential of water sources for sustainable development. The weights of each evaluation index were then determined using the combination assignment approach, which was then suggested. The coupled degree evaluation model of the capability for sustainable development of water sources was then developed. In order to confirm the viability and validity of the suggested model, the model was used to assess the Liwu River water source's capacity for sustainable growth in the context of the South-North Water Transfer in Shandong, China. It is believed that the aforementioned study would serve as a helpful resource when evaluating the capacity of water sources for sustainable development.

Using a Modified Delphi Approach to Explore California’s Possible Transportation and Land Use Futures

Many methods exist for engaging experts in interactive groups to explore, clarify, and/or decide on various issues. In an investigation of four possible future scenarios concerning transportation and land use in California, we developed a novel “hybrid policy Delphi” method for use with a panel of 18 experts. We applied it to explore the policies and practices that would likely lead to each of the four scenarios and the consequences that would result from them. Through our process, panel members discussed and reflected on the scenarios in multiple ways. The scenario they considered most desirable they also deemed least likely to occur, and they foresaw the likely trajectory of California transportation and land use leading to less desirable scenarios. Our mix of discussion and questionnaires traded the benefit of anonymity for the benefit of exploratory, interactive discussion. In addition, our use of surveys before and after meetings allowed us to track changes in panel opinion on a central question and discuss the survey results at meetings, at the cost of greater administrative effort. We discuss the results of this hybrid policy Delphi approach, reflect on how it worked, and conclude with a discussion of limitations and future directions.

18F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS.

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.

Systematic review with expert consensus on use of extracorporeal hemoadsorption in septic shock: An Indian perspective.

Septic shock is a severe form of sepsis characterised by deterioration in circulatory and cellular-metabolic parameters. Despite standard therapy, the outcomes are poor. Newer adjuvant therapy, such as CytoSorb® extracorporeal haemoadsorption device, has been investigated and shown promising outcome. However, there is a lack of some guidance to make clinical decisions on the use of CytoSorb® haemoadsorption as an adjuvant therapy in septic shock in Indian Setting. Therefore, this expert consensus was formulated. To formulate/establish specific consensus statements on the use of CytoSorb® haemoadsorption treatment based on the best available evidence and contextualised to the Indian scenario. We performed a comprehensive literature on CytoSorb® haemoadsorption in sepsis, septic shock in PubMed selecting papers published between January 2011 and March 2023 2021 in English language. The statements for a consensus document were developed based on the summarised literature analysis and identification of knowledge gaps. Using a modified Delphi approach combining evidence appraisal and expert opinion, the following topics related to CytoSorb® in septic shock were addressed: need for adjuvant therapy, initiation timeline, need for Interleukin -6 levels, duration of therapy, change of adsorbers, safety, prerequisite condition, efficacy endpoints and management flowchart. Eleven expert members from critical care, emergency medicine, and the intensive care participated and voted on nine statements and one open-ended question. Eleven expert members from critical care, emergency medicine, and the intensive care participated and voted on nine statements and one open-ended question. All 11 experts in the consensus group (100%) participated in the first, second and third round of voting. After three iterative voting rounds and adapting two statements, consensus was achieved on nine statements out of nine statements. The consensus expert panel also recognised the necessity to form an association or society that can keep a registry regarding the use of CytoSorb® for all indications in the open-ended question (Q10) focusing on "future recommendations for CytoSorb® therapy". This Indian perspective consensus statement supports and provides guidance on the use of CytoSorb® haemoadsorption as an adjuvant treatment in patients with septic shock to achieve optimal outcomes.

Consensus-Derived Recommended Skills for Transition to Residency Courses.

Transition to residency (TTR) courses facilitate the medical student-residency transition and are an integral part of senior medical student training. The authors established a common set of skills for TTR courses, and an expected level of entrustment students should demonstrate in each skill on TTR course completion. A modified Delphi approach was used with 3 survey iterations between 2020 and 2022 to establish skills to be included in a TTR course. Nine TTR experts suggested general candidate skills and conducted a literature search to ensure no vital skills were missed. A stakeholder panel was solicited from email lists of TTR educators, residency program directors, and residents at the panelists' institutions. Consensus was defined as more than 75% of participants selecting a positive inclusion response. An entrustment questionnaire asked panelists to assign a level of expected entrustment to each skill, with 1 indicating observation only and 6 indicating perform independently. The stakeholder panel initially consisted of 118 respondents with representation across educational contexts and clinical specialties. Response rates were 54% in iteration 2, 42% in iteration 3, and 33% on the entrustment questionnaire. After 3 iterations, 54 skills met consensus and were consolidated into 37 final skills categorized into 18 clinical skills (e.g., assessment and management of inpatient concerns), 14 communication skills (e.g., delivering serious news or having difficult conversations), 4 personal and professional skills (e.g., prioritization of clinical tasks), and 1 procedural skill (mask ventilation). Median entrustment levels were reported for all skills, with 19 skills having a level of expected entrustment of 4 (perform independently and have all findings double-checked). These consensus skills can serve as the foundation of a standardized national TTR curriculum framework. Entrustment guidance may help educational leaders optimize training and allocation of resources for TTR curriculum development and implementation.

Publication Recommendations to Report Laboratory Data of Neonates – a Modified Delphi Approach

BackgroundClinical and analytical information on laboratory data of neonates in scientific publications is sparse and incomplete. Furthermore, interpreting neonatal laboratory data can be complex due to their time-dependent and developmental physiology, and paucity of well-established age-appropriate reference ranges for neonates. This study aims to develop publication recommendations to report laboratory data of neonates to enhance the quality of these data in research and clinical care.MethodsA modified Delphi approach was used to develop recommendations in cooperation with the International Neonatal Consortium. A Core Group, including different stakeholders, was responsible for developing the recommendations, in collaboration with a Reflection Group, responsible for providing additional input.ResultsThe recommendations were classified into three categories: ‘Clinical Characteristics’, ‘Bio-analytical Information’ and ‘Data-analytical Information’. These were each divided into ‘Core Data’ (always to be reported) and ‘Supplemental Considerations’ (to be reported when considered relevant to the study).ConclusionOur recommendations provide guidance on standardization of neonatal laboratory data in publications. This will enhance the comparison, replication, and application of study results in research initiatives and clinical practice. Furthermore, these recommendations also serve as foundational work to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts.ImpactStandardized reporting of neonatal laboratory data in scientific publications will enhance the comparison, replication, and application of study results in research initiatives and clinical practice, as well as improve reporting to regulatory agencies.To integrate multistakeholder perspectives, a modified Delphi approach was used to develop publication recommendations which strengthens the applicability of the recommendations.Implementation of standardization will likely improve the overall quality of neonatal clinical research and neonatal healthcare.In addition, these recommendations are foundational to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts.

A mobile application for postoperative education of caregivers of children with congenital hypospadias: Requirement analysis.

Hypospadias, a congenital anomaly, can have long-term effects on sexual, urinary, and reproductive functions, making proper postoperative care essential for desirable outcomes, which could be facilitated through a mobile application for diseases with long-term complications. The aim of this study was to investigate the data and functional requirements or minimum data set of a postoperative education mobile application for caregivers of children with hypospadias. A literature review of papers published until April 2023 using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was conducted to determine the data and functional requirements of a mobile application that provides postoperative education to caregivers of children with congenital hypospadias. Based on the results, a questionnaire was prepared, and its content validity and reliability were evaluated by CVI and CVR. Additionally, data was examined by 30 residents, specialists, and subspecialists in pediatric surgery using the Delphi approach. The study identified 28 data elements in three main categories: demographic data, clinical data, and application function. Functional requirements of the mobile application were suggested for use in designing the application. Also, the most critical data elements included the definition of disease, the importance of treatment, surgical preparation, bandage, hygiene, symptoms and infection, bleeding, and emergency condition. The study will pave the way for developing postoperative educational applications for caregivers of children with congenital hypospadias. M-Health app developers and clinician specialists can utilize these findings to design practical applications that assist caregivers in managing the care of hypospadias patients.

AO Spine/Praxis Clinical Practice Guidelines for the Management of Acute Spinal Cord Injury: An Introduction to a Focus Issue.

Narrative overview and summary. The objective of this introductory manuscript is to provide an overview of the effort that was undertaken to establish clinical practice guidelines for a number of important topics in spinal cord injury (SCI). These topics included: 1. The role and timing of surgical decompression after acute traumatic SCI; 2. The hemodynamic management of acute traumatic SCI; and 3. The definition, diagnosis, and management of intra-operative SCI. Here, we introduce the rationale for the guidelines, the methodology utilized, and summarize how the topics are addressed within various manuscripts of this Focus Issue. The key clinical questions were defined using the PICO format for treatment reviews (patient; intervention; comparison; outcomes) or PPO format (patient, prognostic factor, outcomes) for risk factor review. Multi-disciplinary, international guideline development groups (GDGs) were established to evaluate and collate the available evidence in a rigorous, systematic manner, followed by a review of systematically obtained evidence within the framework of the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) criteria and application of the Evidence to Decision process. Consensus meetings, using a modified Delphi approach, were held with the multidisciplinary, international GDGs using online video-conferencing technology and anonymous voting to develop the final recommendations for each of the topics addressed. All systematic review protocols followed PRISMA standards and were registered on PROSPERO; all potential conflicts were vetted in an open and transparent manner. The funders (AO Spine and Praxis Spinal Cord Institute) had no influence over editorial content or the guidelines process). Updated guidelines were established for the timing of surgical decompression after acute SCI, with surgical decompression within 24hours of injury now "recommended" as a treatment option. Updated guidelines were also established for hemodynamic management, with an expanded target range for mean arterial pressure (MAP) of 75-80 to 90-95mmHg for between 3 to 7days post-injury now "suggested" as a treatment option. The available literature mandated scoping and systematic reviews on the topic of intra-operative SCI, and this resulted in manuscripts to address the definition, frequency, and risk factors, to define the role of intra-operative neuromonitoring, and to suggest an evidence-based care pathway for management. A rigorous process following GRADE standards was undertaken to review the available evidence and establish guideline recommendations around the role and timing of surgery in acute SCI, optimal hemodynamic management of acute SCI and the prevention, diagnosis and management of intraoperative SCI. This effort also identified key knowledge gaps and future directions for study, which will serve to refine these recommendations in the future.

Identifying teaching competencies for medical residents using a modified Delphi method.

This study aimed to identify the teaching competencies of medical residents. A modified Delphi study was conducted from January to March 2017. Twenty-four panelists (six medical educators, program directors, chief residents, and residents each) from various facilities in Japan participated in the study. The consensus criterion for this study was that more than 80% of the panelists gave a rating of 6 or higher on the 7-point Likert scale ("not at all important" to "extremely important") without any comments. The modified Delphi approach resulted in a list of 27 resident teaching competencies after three rounds. These competencies were categorized based on Harden and Crosby's 12 roles of medical teachers. Our study revealed that, of the 12 roles, residents were primarily viewed as "clinical or practical teachers," "teaching role models," "on-the-job role models," "learning facilitators," and "student assessors." The 27 resident teaching competencies indicate the importance of educational proximity for residents as teachers. It is expected that this finding will contribute to competency-based resident-as-teacher education.

Multidisciplinary Decision-Making-ITAlian Consensus After Two Years of Real Practice on the Management of Severe Uncontrolled CRSwNP by Biologics (ITACA Study).

We aimed to reach an Italian multidisciplinary consensus on some crucial aspects of treatment decision making in CRSwNP, following 2years of clinical experience in order to support specialists in the management of CRSwNP in clinical practice. We addressed issues relating to therapeutic decision-making and shared criteria for the treatment choice, as well as appropriate timing and criteria for evaluating treatment response, and highlighted the need for repeated multidisciplinary assessments. A national survey has been conducted recently to understand how rhinology practice has changed in Italy with the advent of biologics and how this affects patients with uncontrolled, severe CRSwNP. Despite the many published consensus documents, practical recommendations, and protocols on the use of biologics in CRSwNP, heterogenous behaviors in practice are still observed mainly conditioned by the novelty of the topic. The consensus procedure followed a modified Delphi approach. The scientific board included 18 otorhinolaryngologists and 8 allergists, who selected the 4 main topics to be addressed and developed overall 20 statements. Consensus on these statements was sought by a larger group of 48 additional experts, through two rounds of voting, the first web-based, the second in presence with discussion and possible refinement of the statements. The statements reaching an average score ≥ 7 at the second voting round were approved. Five statements were proposed for each of the following topics: baseline evaluation of patients eligible for biologic therapy; choice between different therapeutic options; assessment of the response to biologic treatment; multidisciplinary management. At the first voting round, 19 out of the 20 statements reached a mean score ≥ 7. Following the discussion and a few consequent amendments, at the second round of voting all the 20 statements were approved.

Matching the right study design to decision-maker questions: Results from a Delphi study.

Research evidence can play an important role in each stage of decision-making, evidence-support systems play a key role in aligning the demand for and supply of evidence. This paper provides guidance on what type of study designs most suitably address questions asked by decision-makers. This study used a two-round online Delphi approach, including methodological experts in different areas, disciplines, and geographic locations. Participants prioritized study designs for each of 40 different types of question, with a Kendall's W greater than 0.6 and reaching statistical significance (p<0.05) considered as a consensus. For each type of question, we sorted the final rankings based on their median ranks and interquartile ranges, and listed the four study designs with the highest median ranks. Participants provided 29 answers in the two rounds of the Delphi, and reached a consensus for 28 (out of the 40) questions (eight in the first round and 20 in the second). Participants achieved a consensus for 8 of 15 questions in stage I (clarifying a societal problem, its causes, and potential impacts), 12 of 13 in stage II (finding options to address a problem) and four of six in each of stages III (implementing or scaling-up an option) and IV (monitoring implementation and evaluating impact). This paper provides guidance on what study designs are more suitable to give insights on 28 different types of questions. Decision-makers, evidence intermediaries (, researchers and funders can use this guidance to make better decisions on what type of study design to commission, use or fund when answering specific needs.

REDISCOVER International Guidelines on the Perioperative Care of Surgical Patients With Borderline-resectable and Locally Advanced Pancreatic Cancer.

The REDISCOVER consensus conference aimed at developing and validating guidelines on the perioperative care of patients with borderline-resectable (BR-) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC). Coupled with improvements in chemotherapy and radiation, the contemporary approach to pancreatic surgery supports the resection of BR-PDAC and, to a lesser extent, LA-PDAC. Guidelines outlining the selection and perioperative care for these patients are lacking. The Scottish Intercollegiate Guidelines Network (SIGN) methodology was used to develop the REDISCOVER guidelines and create recommendations. The Delphi approach was used to reach a consensus (agreement ≥80%) among experts. Recommendations were approved after a debate and vote among international experts in pancreatic surgery and pancreatic cancer management. A Validation Committee used the AGREE II-GRS tool to assess the methodological quality of the guidelines. Moreover, an independent multidisciplinary advisory group revised the statements to ensure adherence to nonsurgical guidelines. Overall, 34 recommendations were created targeting centralization, training, staging, patient selection for surgery, possibility of surgery in uncommon scenarios, timing of surgery, avoidance of vascular reconstruction, details of vascular resection/reconstruction, arterial divestment, frozen section histology of perivascular tissue, extent of lymphadenectomy, anticoagulation prophylaxis, and role of minimally invasive surgery. The level of evidence was however low for 29 of 34 clinical questions. Participants agreed that the most conducive means to promptly advance our understanding in this field is to establish an international registry addressing this patient population ( https://rediscover.unipi.it/ ). The REDISCOVER guidelines provide clinical recommendations pertaining to pancreatectomy with vascular resection for patients with BR-PDAC and LA-PDAC, and serve as the basis of a new international registry for this patient population.