Three-round Modified Delphi Process Research Articles

Major Publications in the Critical Care Pharmacotherapy Literature: 2023.

We aimed to summarize the most significant and impactful publications describing the pharmacotherapeutic care of critically ill patients in 2023. PubMed/MEDLINE and the Clinical Pharmacy and Pharmacology Pharmacotherapy Literature Update. Randomized controlled trials and prospective studies of adult critically ill patients assessing a pharmacotherapeutic intervention and reporting clinical endpoints published between January 1, 2023, and December 31, 2023, were eligible for inclusion in this article. Articles from a systematic search and the Clinical Pharmacy and Pharmacology Pharmacotherapy Literature Update were included. An a priori defined three-round modified Delphi process was employed to achieve consensus on the most impactful publications based on the following considerations: 1) overall contribution to scientific knowledge and 2) novelty to the literature. The systematic search and Clinical Pharmacy and Pharmacology Pharmacotherapy Literature Update returned a total of 1202 articles, of which 1164 were excluded. The remaining 38 articles underwent a three-round modified Delphi process. In each round, articles were independently scored based on overall contribution to scientific knowledge and novelty to the literature. Included articles are summarized and their impact discussed. Article topics included hydrocortisone for severe community-acquired pneumonia, inhaled amikacin for prevention of ventilator-associated pneumonia, methylene blue for septic shock, restrictive vs. liberal fluid management for sepsis-induced hypotension, andexanet alfa for major bleeding associated with factor Xa inhibitors, and early administration of four-factor prothrombin complex concentrate in patients with trauma at risk for massive transfusion. This review provides a summary and perspective on the potential impact of the most relevant articles in 2023 describing advances in the pharmacotherapeutic care of critically ill patients.

Delphi Analysis: Optimizing Anatomy Teaching and Ultrasound Training for Botulinum Neurotoxin Type A Injection in Spasticity and Dystonia.

Our objective was to provide expert consensus on best practices for anatomy teaching and training on ultrasound-guided botulinum neurotoxin type A (BoNT-A) injection for specialists involved in treating spasticity and dystonia. Nine experts (three neurologists; six physical medicine and rehabilitation physicians) participated in a three-round modified Delphi process. Over three rounds, experts reached consensus on 15 of 16 statements describing best practices for anatomy and BoNT-A injection training. They unanimously agreed that knowledge of the target audience, including their needs and current competency, is crucial when designing training programs. Experts also agreed that alignment between instructors is essential to ensure consistency of approach over time and between regions, and that training programs should be simple, adaptable, and "hands-on" to enhance engagement and learning. Consensus was also reached for several other key areas of training program development. The best-practice principles identified by expert consensus could aid in the development of effective, standardized programs for anatomy teaching and BoNT-A injection training for the purposes of treating spasticity and dystonia. This will enhance the exchange of knowledge, skills, and educational approaches between global experts, allowing more specialists to treat important movement disorders and ultimately improving patient outcomes.

Best Practices for Point of Care Ultrasound: An Interdisciplinary Expert Consensus.

Despite the growing use of point of care ultrasound (POCUS) in contemporary medical practice and the existence of clinical guidelines addressing its specific applications, there remains a lack of standardization and agreement on optimal practices for several areas of POCUS use. The Society of Point of Care Ultrasound (SPOCUS) formed a working group in 2022 to establish a set of recommended best practices for POCUS, applicable to clinicians regardless of their training, specialty, resource setting, or scope of practice. Using a three-round modified Delphi process, a multi-disciplinary panel of 22 POCUS experts based in the United States reached consensus on 57 statements in domains including: (1) The definition and clinical role of POCUS; (2) Training pathways; (3) Credentialing; (4) Cleaning and maintenance of POCUS devices; (5) Consent and education; (6) Security, storage, and sharing of POCUS studies; (7) Uploading, archiving, and reviewing POCUS studies; and (8) Documenting POCUS studies. The consensus statements are provided here. While not intended to establish a standard of care or supersede more targeted guidelines, this document may serve as a useful baseline to guide clinicians, leaders, and systems considering initiation or enhancement of POCUS programs.

Patients at risk of nontuberculous mycobacterial pulmonary disease who need testing evaluated using a modified Delphi process by European experts

BackgroundIdentifying patients at risk of nontuberculous mycobacterial pulmonary disease (NTM-PD) is challenging. Delays in NTM-PD identification and management are associated with declining lung function and increased morbidity and mortality.Study design and methodsEuropean NTM-PD experts (n=12) participated in a three-round modified Delphi process to score symptoms and comorbidities potentially associated with NTM-PD as reasons to test for nontuberculous mycobacteria.ResultsExperts reached a consensus on the symptoms and comorbidities that should and should not prompt testing for nontuberculous mycobacteria. Requirements for testing were scored as high (mean ≥7), medium (mean ≥4–<7) or low (mean <4). Nontuberculous mycobacteria testing should be undertaken when multiple suggestive symptoms are present simultaneously in all patients except those with cancer (7.3–8.8), or when radiology is indicative of NTM-PD (≥8.9). Symptoms of persistent sputum production, recurrent respiratory infection and haemoptysis should prompt testing for nontuberculous mycobacteria, particularly in those with underlying respiratory diseases. Symptomatic patients with bronchiectasis or previous tuberculosis/NTM-PD or those being prescribed or undergoing long-term macrolide therapy for a respiratory condition should also be tested. Testing is not warranted in patients without an underlying respiratory disorder or in those without a history of respiratory disorders unless presenting with multiple symptoms.ConclusionsAssessing patients’ risk of NTM-PD is challenging. This Delphi consensus process provides insight into symptoms and clinical characteristics that should prompt NTM-PD assessment. Timely testing and diagnosis would enable initiation of appropriate management.

Technical Skills Curriculum in Neonatology: A Modified European Delphi Study

Introduction: Simulation-based training (SBT) aids healthcare providers in acquiring the technical skills necessary to improve patient outcomes and safety. However, since SBT may require significant resources, training all skills to a comparable extent is impractical. Hence, a strategic prioritization of technical skills is necessary. While the European Training Requirements in Neonatology provide guidance on necessary skills, they lack prioritization. We aimed to identify and prioritize technical skills for a SBT curriculum in neonatology. Methods: A three-round modified Delphi process of expert neonatologists and neonatal trainees was performed. In round one, the participants listed all the technical skills newly trained neonatologists should master. The content analysis excluded duplicates and non-technical skills. In round two, the Copenhagen Academy for Medical Education and Simulation Needs Assessment Formula (CAMES-NAF) was used to preliminarily prioritize the technical skills according to frequency, importance of competency, SBT impact on patient safety, and feasibility for SBT. In round three, the participants further refined and reprioritized the technical skills. Items achieving consensus (agreement of ≥75%) were included. Results: We included 168 participants from 10 European countries. The response rates in rounds two and three were 80% (135/168) and 87% (117/135), respectively. In round one, the participants suggested 1964 different items. Content analysis revealed 81 unique technical skills prioritized in round two. In round three, 39 technical skills achieved consensus and were included. Conclusion: We reached a European consensus on a prioritized list of 39 technical skills to be included in a SBT curriculum in neonatology.

Quality indicators for collaborative care networks in persistent somatic symptoms and functional disorders: a modified delphi study

BackgroundCare for persistent somatic symptoms and functional disorders (PSS/FD) is often fragmented. Collaborative care networks (CCNs) may improve care quality for PSS/FD. Effectiveness likely depends on their functioning, but we lack a straightforward quality evaluation system. We therefore aimed to develop quality indicators to evaluate CCNs for PSS/FD.MethodUsing an online three-round modified Delphi process, an expert panel provided, selected and ranked quality indicators for CCNs in PSS/FD. Recruited experts were diverse healthcare professionals with relevant experience in PSS/FD care in the Netherlands.ResultsThe expert panel consisted of 86 professionals representing 15 disciplines, most commonly physiotherapists, psychologists and medical specialists. 58% had more than 10 years experience in PSS/FD care. Round one resulted in 994 quotations, which resulted in 46 unique quality indicators. These were prioritised in round two and ranked in round three by the panel, resulting in a final top ten. The top three indicators were: “shared vision of care for PSS/FD”, “pathways tailored to the individual patient”, and “sufficiently-experienced caregivers for PSS/FD”.ConclusionsThe identified quality indicators to evaluate CCNs in the field of PSS/FD can be implemented in clinical practice and may be useful in improving services and when assessing effectiveness.

Adaptation and validation of the Children’s Surgical Assessment Tool for Rwandan district hospitals

ABSTRACT Background/Aims Paediatric surgical care is a critical component of child health and basic universal health coverage and therefore should be included in comprehensive evaluations of surgical capacity. This study adapted and validated the Children’s Surgical Assessment Tool (CSAT), a tool developed for district and tertiary hospitals in Nigeria to evaluate hospital infrastructure, workforce, service delivery, financing, and training capacity for paediatric surgery, for use in district hospitals in Rwanda. Methods We used a three-round modified Delphi process to adapt the CSAT to the Rwandan context. An expert panel of surgeons, anaesthesiologists, paediatricians, and health systems strengthening experts were invited to participate based on their experience with paediatric surgical or anaesthetic care at district hospitals or with health systems strengthening in the Rwandan context. We used the Content Validity Index to validate the final tool. Results The adapted tool had a final score of 0.84 on the Content Validity Index, indicating a high level of agreement among the expert panel. The final tool comprised 171 items across five domains: facility characteristics, service delivery, workforce, financing, and training/research. Conclusion The adapted CSAT is appropriate for use in district hospitals in Rwanda to evaluate the capacity for paediatric surgery. This study provides a framework for adapting and validating a comprehensive paediatric surgical assessment tool to local contexts in LMICs and used in similar settings in sub-Saharan Africa.

Major Publications in the Critical Care Pharmacotherapy Literature: 2022.

A number of trials related to critical care pharmacotherapy were published in 2022. We aimed to summarize the most influential publications related to the pharmacotherapeutic care of critically ill patients in 2022. PubMed/Medical Literature Analysis and Retrieval System Online and the Clinical Pharmacy and Pharmacology Pharmacotherapy Literature Update. Randomized controlled trials, prospective studies, or systematic review/meta-analyses of adult critically ill patients assessing a pharmacotherapeutic intervention and reporting clinical endpoints published between January 1, 2022, and December 31, 2022, were included in this article. Articles from a systematic search and the Clinical Pharmacy and Pharmacology Pharmacotherapy Literature Update were included and stratified into clinical domains based upon consistent themes. Consensus was obtained on the most influential publication within each clinical domain utilizing an a priori defined three-round modified Delphi process with the following considerations: 1) overall contribution to scientific knowledge and 2) novelty to the literature. The systematic search and Clinical Pharmacy and Pharmacology Pharmacotherapy Literature Update yielded a total of 704 articles, of which 660 were excluded. The remaining 44 articles were stratified into the following clinical domains: emergency/neurology, cardiovascular, gastroenterology/fluids/nutrition, hematology, infectious diseases/immunomodulation, and endocrine/metabolic. The final article selected from each clinical domain was summarized following a three-round modified Delphi process and included three randomized controlled trials and three systematic review/meta-analyses. Article topics summarized included dexmedetomidine versus other sedatives during mechanical ventilation, beta-blocker treatment in the critically ill, restriction of IV fluids in septic shock, venous thromboembolism prophylaxis in critically ill adults, duration of antibiotic therapy for Pseudomonas aeruginosa ventilator-associated pneumonia, and low-dose methylprednisolone treatment in severe community-acquired pneumonia. This concise review provides a perspective on articles published in 2022 that are relevant to the pharmacotherapeutic care of critically ill patients and their potential impact on clinical practice.

Early labour experience questionnaire: Translation and cultural adaptation into German

ProblemEvidence on early labour care suggests that women’s needs are not adequately met. BackgroundWomen’s perceptions of early labour management impact on their overall birth experience. Valid measurement tools are needed for evaluation and improvement of early labour care. AimTranslation and cultural adaptation of the Early Labour Experience Questionnaire for use in a German context. MethodsTranslation and adaptation followed internationally recognised guidelines. The process comprised for- and backward translation, an expert panel review using a three-round modified Delphi process and cognitive interviews with representatives of the target group using paraphrasing and retrospective probing. The interviews were conducted online, video-recorded and transcribed. Based on the results of the interviews the pilot version of the questionnaire was compiled. FindingsNine experts, including a representative of the target group, participated in the Delphi process. Twelve cognitive interviews were conducted. Most of the translation and adaptation issues needing clarification related to differences in the organisation of maternity care, the term early labour and the translation of the single word expressions for women’s affective state in early labour. Few problems emerged during cognitive interviews and related to conceptual understanding, reference points, instructions, and response categories. The pilot version of the German Early Labour Experience Questionnaire (G-ELEQ) comprises a total of 25 items. ConclusionWith the G-ELEQ a tool for measuring women’s early labour experience in the German context with good face and content validity is available. Psychometric testing is now needed to assess the instrument’s validity and reliability.

Generating consensus on road safety issues and priorities in Ghana: A modified Delphi approach

BackgroundImplementation of evidence-based approaches to reduce the substantial health, social, and financial burdens of road traffic injuries and deaths in Ghana and other low-and-middle-income countries (LMICs) is vitally important. Consensus from national stakeholders can provide insight into what evidence to generate and which interventions to prioritize for road safety. The main objective of this study was to elicit expert views on the barriers to reaching international and national road safety targets, the gaps in national-level research, implementation, and evaluation, and the future action priorities. Materials and MethodsWe used an iterative three-round modified Delphi process to generate consensus among Ghanaian road safety stakeholders. We defined consensus as 70% or more stakeholders selecting a specific response in the survey. We defined partial consensus (termed “majority”) as 50% or more stakeholders selecting a particular response. ResultsTwenty-three stakeholders from different sectors participated. Experts generated consensus on barriers to road safety goals, including the poor regulation of commercial and public transport vehicles and limited use of technology to monitor and enforce traffic behaviors and laws. Stakeholders agreed that the impact of increasing motorcycle (2- and 3-wheel) use on road traffic injury burden is poorly understood and that it is a priority to evaluate road-user risk factors such as speed, helmet use, driving skills, and distracted driving. One emerging area was the impact of unattended/disabled vehicles along roadways. There was consensus on the need for additional research, implementation, and evaluation efforts of several interventions, including focused treatment of hazardous spots, driver training, road safety education as part of academic curricula, promotion of community involvement in first aid, development of strategically positioned trauma centers, and towing of disabled vehicles. ConclusionThis modified Delphi process with stakeholders from Ghana generated consensus on road safety research, implementation, and evaluation priorities.

Delphi Panel on the Dimensions and Assessment of Functional Recovery in First-Episode and Early-Phase Schizophrenia Patients

AbstractFunctional recovery is a treatment goal that goes beyond symptomatic remission and encompasses multiple aspects of schizophrenia patients’ lives, including quality of life, physical, and mental functioning. There is evidence that long-acting injectable (LAI) treatments promote adherence and reduce rehospitalisation and functional decline, which could facilitate patients’ ability to reach functional recovery. Despite this, LAIs are underused in the first-episode (FEP) and early-phase (EP) patient population, due to physician hesitancy and concerns around stigma. A Delphi panel was held to gain expert consensus on an approach to the domains and assessment of functional recovery elements in FEP and EP schizophrenia patients.A literature review and input from a steering committee of 5 experts in psychiatry informed statements development for a three-round modified Delphi process. Round one was conducted via one-to-one video conference interviews, and the successive rounds were conducted via electronic surveys, which enabled international collaboration. Statements on the different domains and assessment for functional recovery were presented to 17 psychiatrists, practicing in 7 countries (France, Italy, US, Germany, Spain, Denmark, and UK), experienced in the treatment of schizophrenia with LAIs. Several analysis rules determined whether a statement could progress to the next round and specified the level of agreement required to achieve consensus. Measures of central tendency (mode, mean) and variability (interquartile range) were reported back to help panelists look at their previous responses in the context of the overall group.A consensus was reached (defined a priori as ≥80% agreement) on all 27 statements covering the dimensions, assessment, and level of achieved functional recovery for FEP and EP patients. The following domains are important to consider when assessing functional recovery: depression, aggressive behaviour, social interaction, family functioning, education/employment, sexual functioning, and leisure activities. Additionally, panellists reached consensus that dimensions should be minimally impairing, if present (excluding sexual functioning) and asked about at every encounter with the patient (excluding sexual functioning and leisure activities). In summary, this Delphi panel yielded agreement that functional recovery is multidimensional and should be assessed regularly as part of usual care on an individual patient level in FEP and EP schizophrenia patients.FundingLundbeck Otsuka Alliance

Curated collections for educators: Nine key articles and article series for teaching qualitative research methods.

Qualitative research explains observations, focusing on how and why phenomena and experiences occur. Qualitative methods go beyond quantitative data and provide critical information inaccessible through quantitative methods. However, at all levels of medical education, there is insufficient exposure to qualitative research. As a result, residents and fellows complete training ill-equipped to appraise and conduct qualitative studies. As a first step to increasing education in qualitative methods, we sought to create a curated collection of papers for faculty to use in teaching qualitative research at the graduate medical education (GME) level. We conducted literature searches on the topic of teaching qualitative research to residents and fellows and queried virtual medical education and qualitative research communities for relevant articles. We searched the reference lists of all articles found through the literature searches and online queries for additional articles. We then conducted a three-round modified Delphi process to select papers most relevant to faculty teaching qualitative research. We found no articles describing qualitative research curricula at the GME level. We identified 74 articles on the topic of qualitative research methods. The modified Delphi process identified the top nine articles or article series most relevant for faculty teaching qualitative research. Several articles explain qualitative methods in the context of medical education, clinical care, or emergency care research. Two articles describe standards of high-quality qualitative studies, and one article discusses how to conduct the individual qualitative interview to collect data for a qualitative study. While we identified no articles reporting already existing qualitative research curricula for residents and fellows, we were able to create a collection of papers on qualitative research relevant to faculty seeking to teach qualitative methods. These papers describe key qualitative research concepts important in instructing trainees as they appraise and begin to develop their own qualitative studies.

Expert consensus established around flexible, individualized migraine treatment utilizing a modified Delphi panel.

To characterize treatment decision-making processes and formalize consensus regarding key factors headache specialists consider in treatment decisions for patients with migraine, considering novel therapies. Migraine therapies have long been subject to binary classification, acute versus preventive, due to limitations of available drugs. The emergence of novel therapies that can be used more flexibly creates an opportunity to rethink this binary classification. To determine the role of these novel therapies in treatment, it is critical to understand whether existing guidelines reflect clinical practice and to establish consensus around factors driving management. A three-round modified Delphi process was conducted with migraine clinical experts. Round 1 consisted of an online questionnaire; Round 2 involved an online discussion of aggregated Round 1 results; and Round 3 allowed participants to revise Round 1 responses, incorporating Round 2 insights. Questions elicited likelihood ratings (0= highly unlikely to 100=highly likely), rankings, and estimates on treatment decision-making. Nineteen experts completed three Delphi rounds. Experts strongly agreed on definitions for "acute" (median= 100, inter-quartile range [IQR]=5) and "preventive" treatment (median=90, IQR=15), but noted a need for treatment customization for patients (median=100, IQR=6). Experts noted certain aspects of guidelines may no longer apply based on established tolerability and efficacy of newer acute and preventive agents (median=91, IQR=17). Further, experts agreed on a treatment category referred to as "situational prevention" (or "short-term prevention") for patients with reliable and predictable migraine triggers (median=100, IQR=10) or time-limited periods when headache avoidance is important (median=100, IQR=12). Using the modified Delphi method, a panel of migraine experts identified the importance of customizing treatment for people with migraine and the utility of "situational prevention," given the ability of new treatment options to meet this need and the potential to clinically identify patients and time periods when this approach would add value.

Cancer-related Fatigue in Lung Cancer: A Research Agenda: An Official American Thoracic Society Research Statement.

Background: Fatigue is the most common symptom among cancer survivors. Cancer-related fatigue (CRF) may occur at any point in the cancer care continuum. Multiple factors contribute to CRF development and severity, including cancer type, treatments, presence of other symptoms, comorbidities, and medication side effects. Clinically, increasing physical activity, enhancing sleep quality, and recognizing sleep disorders are integral to managing CRF. Unfortunately, CRF is infrequently recognized, evaluated, or treated in lung cancer survivors despite more frequent and severe symptoms than in other cancers. Therefore, increased awareness and understanding of CRF are needed to improve health-related quality of life in lung cancer survivors. Objectives: 1) To identify and prioritize knowledge and research gaps and 2) to develop and prioritize research questions to evaluate mechanistic, diagnostic, and therapeutic approaches to CRF among lung cancer survivors. Methods: We convened a multidisciplinary panel to review the available literature on CRF, focusing on the impacts of physical activity, rehabilitation, and sleep disturbances in lung cancer. Weused a three-round modified Delphi process to prioritize research questions. Results: This statement identifies knowledge gaps in the 1)detection and diagnostic evaluation of CRF in lung cancer survivors; 2) timing, goals, and implementation of physical activity and rehabilitation; and 3) evaluation and treatment of sleep disturbances and disorders to reduce CRF. Finally, we present the panel's initial 32 research questions and seven final prioritized questions. Conclusions: This statement offers a prioritized research agenda to 1) advance clinical and research efforts and 2) increase awareness of CRF in lung cancer survivors.

Endoscopic management of patients with high-risk colorectal colitis–associated neoplasia: a Delphi study

Current guidelines recommend endoscopic resection of visible and endoscopically resectable colorectal colitis-associated neoplasia (CAN) in patients with inflammatory bowel disease (IBD). However, patients with high risk CAN are often not amenable to conventional resections techniques and a consensus approach for the endoscopic management of these lesions is presently lacking. This Delphi study aims to reach consensus amongst experts on the endoscopic management of these lesions. A three-round modified Delphi process was conducted to reach consensus amongst worldwide IBD and/or endoscopy experts (n=18) from three continents. Consensus was considered if ≥ 75% agreed or disagreed. Quality of evidence was assessed by the criteria of the Cochrane Collaboration group. Consensus was reached on all statements (n=14). Experts agreed on a definition for CAN and high-risk CAN (HR-CAN). Consensus was reached on the examination of the colon with enhanced endoscopic imaging prior to resection, the endoscopic resectability of a HR-CAN lesion and endoscopic assessment and standard report of CAN lesions. In addition, experts agreed on type of resections of HR-CAN (< 20mm, >20 mm, with or without good lifting), endoscopic success (technical success and outcomes), histologic assessment and follow-up in HR-CAN. This is the first step in developing international consensus-based recommendations for endoscopic management of (HR-)CAN. Although the quality of available evidence was considered low, consensus was reached on several aspects of the management of (HR-)CAN. The present work and proposed standardization might benefit future studies.

Quality Evaluation of a Checklist for Intubation Preparation in Graduate Medical Education.

BackgroundRapid sequence intubation (RSI) is a multistep process that emergency physicians commonly perform. Unfortunately, there is little published in the graduate medical education literature regarding the use of checklists for RSI education.MethodsWe developed a pre-intubation checklist for RSI preparation and evaluated emergency medicine residents’ use of it. We developed the checklist using a three-round modified Delphi process among a group of emergency medicine faculty physicians within our institution. Over a three-year period, residents were randomized into two groups: a “checklist group” and a “without-checklist group.” Residents were then evaluated for RSI critical step completion in a simulated critically ill patient by two independent study investigators. Inter-rater reliability kappa scores were calculated. Following completion of the scenario, residents in both groups were asked to complete an anonymous survey. Both groups had access to the checklist at the time of the survey. The survey was used to determine if they found the checklist helpful. Odds ratios with p-values, at an alpha of 0.05 for significance, were computed for checklist items comparing the checklist and without-checklist groups. Data analysis was performed using SAS software (SAS, Cary, NC v 9.4). This study was approved by the authors’ Institutional Review Board.ResultsEach assessment was completed by two investigators. Inter-rater reliability was substantial (κ=0.79). Residents having access to the checklist were more likely to verbalize a critical step with a p-value of < 0.0001 and an odds ratio of 2.17 (95% CI: 1.48, 3.19). The checklist group normalized vital signs prior to intubation in 25/28 (89%, 95% CI: 72.81, 96.29) versus only 6/29 (21%, 95% CI: 9.85, 38.39) with a p-value of <0.0001 in the without-checklist group. The checklist group evaluated for difficult laryngoscopy 26/28 (93%, 95% CI: 77.36, 98.02) versus only 21/29 (72%, CI 95% 54.28, 85.30) with p=0.0223 in the without-checklist group. All of the surveyed residents indicated that the checklist would be helpful for future use in the ED.ConclusionThis RSI checklist improved adherence to preparatory steps of RSI. Utilizing a checklist increased evaluation for a difficult airway and normalizing vital signs. Residents found the checklist helpful for ED use.

Standardized Outcome Measures for Preterm and Hospitalized Neonates: An ICHOM Standard Set

Introduction: Approximately, one in ten infants is born preterm or requires hospitalization at birth. These complications at birth have long-term consequences that can extend into childhood and adulthood. Timely detection of developmental delay through surveillance could enable tailored support for these babies and their families. However, the possibilities for follow-up are limited, especially in middle- and low-income countries, and the tools to do so are either not available or too expensive. A standardized and core set of outcomes for neonates, with feasible tools for evaluation and follow-up, could result in improving quality, enhance shared decision-making, and enable global benchmarking. Methods: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group, which was comprised of 14 health-care professionals (HCP) and 6 patient representatives in the field of neonatal care. An outcome set was developed using a three-round modified Delphi process, and it was endorsed through a patient representative-validation survey and an HCP survey. Results: A literature review revealed 1,076 articles and 26 registries which were screened for meaningful outcomes, patient-reported outcome measures, clinical measures, and case mix variables. This resulted in a neonatal set with 21 core outcomes covering three domains (physical, social, and mental functioning) and 14 tools to assess these outcomes at three timepoints. Discussion: This set can be implemented globally and it will allow comparison of outcomes across different settings and countries. The transparent consensus-driven development process which involved stakeholders and professionals from all over the world ensures global relevance.

Expert Panel Consensus on Management of Advanced Cancer-related Pain in Individuals with Opioid Use Disorder

Develop consensus on the appropriateness of cancer pain management strategies in individuals with co-occurring advanced cancer and OUD. Three-round modified-Delphi process with two cases: patient with advanced cancer, pain and OUD treated with buprenorphine/naloxone or methadone. Participants rated management strategies in Round 1, discussed results in Round 2, and provided final responses in Round 3 in an online modified-Delphi panel. Participants included experts in palliative care, addiction, or both, recruited by email from palliative care and addiction-focused professional groups, lists from prior studies, and snowball sampling. Of 120 experts, the majority of whom held MD or DO degrees (115, 96%), 70% participated in all rounds. For a patient with OUD on buprenorphine/naloxone, it was deemed appropriate to continue buprenorphine/naloxone with three-times-per-day dosing. Continuing buprenorphine/naloxone and adding a full-agonist opioid was deemed appropriate for patients with a prognosis of weeks-months, and of uncertain appropriateness for a prognosis of months-years. For a patient with OUD on methadone dispensed at a methadone clinic, it was deemed appropriate to take over prescribing and dose 2-3x/day. Continuing methadone daily while adding another full-agonist opioid was deemed appropriate for patients with a prognosis of weeks-months and of uncertain appropriateness for a prognosis of months-years. This qualitative study, urgently needed, consensus-based guidance for clinicians, and highlighted critical research and policy gaps needed to facilitate implementation. Findings underscore the importance of additional research to investigate optimal dosing of buprenorphine/naloxone and methadone in patients with advanced cancer pain and OUD, and factors influencing the preferred choice. Grant support from the Cambia Health Foundation.

Introduction of Subcutaneous Infliximab CT-P13 and Vedolizumab in Clinical Practice: A Multi-Stakeholder Position Statement Highlighting the Need for Post-Marketing Studies.

Although subcutaneous formulations of infliximab CT-P13 and vedolizumab are registered for treating moderate-to-severe inflammatory bowel disease [IBD], many questions on their use remain unanswered. We set up a multi-stakeholder initiative resulting in a position statement. Based on publicly available data, statements on subcutaneous infliximab and vedolizumab were developed and reviewed by 45 Belgian IBD physicians in a three-round modified Delphi process. During a consensus meeting, input from 16 IBD patients, nine IBD nurses and two clinical pharmacologists was provided and statements were further discussed, modified and scored. Statements achieving agreement by at least 70% of the IBD physicians were accepted. The Delphi process resulted in 79 agreed statements. In patients initiating intravenous therapy, IBD physicians would only consider switching to subcutaneous formulations in patients achieving both clinical and biological response [for Crohn's disease] or both clinical and endoscopic response [for ulcerative colitis]. For patients under maintenance therapy, switching to subcutaneous formulations was only considered in those achieving both clinical and endoscopic response while receiving standard dosing of infliximab or vedolizumab. While awaiting more scientific data, IBD physicians should consider weekly subcutaneous injections or switching back to an intravenous formulation in case of loss of response. Finally, switching to a subcutaneous formulation should always be a shared decision. All stakeholders welcomed subcutaneous infliximab and vedolizumab. However, more scientific data are needed to select the right patients and timing for switching to these newer formulations, and to explore the optimal strategy in case of loss of response.

Curated collections for educators: Six key papers on teaching procedural skills.

Competence in teaching procedural skills is required for faculty in all specialties. Regardless of involvement in undergraduate medical education (UME) versus graduate medical education (GME), faculty will likely be involved in teaching procedures to novice learners at some point, with the goal of having the learner achieve graduated independence and technical competence in a skill set. A large body of literature exists addressing the best practices for teaching and maintaining procedural skills. We searched for articles that describe the best practices for teaching procedural skills to all levels of learners. We conducted a literature search for papers on procedural skills training and teaching. We also made a call for papers on social media from members of the online #MedEd and #FOAMed communities. Once a list of the articles was compiled, we conducted a three-round modified Delphi process to identify those illustrating best practices for teaching procedural skills by both junior and senior faculty. We identified 98 relevant articles on the topic of procedural skills training. Six articles were deemed to be highly relevant after three rounds of the modified Delphi. Best practices included using an established educational framework when designing procedural skills teaching sessions, providing positive feedback to learners with opportunities for improvement, and demonstrating the procedure to the learners. Medical educators should employ evidence-based practices when designing and delivering procedural skills sessions. Educational frameworks provide faculty developers and facilitators with an organized approach to teaching these sessions. Maintenance of procedural skills over time is key; faculty can utilize simulation-based procedural training and deliberate practice to prevent decay of learned skills.