CASCADE: A Community-Engaged Action Model for Generating Rapid, Patient-Engaged Decisions in Clinical Research.

Background: Integrating patient and community input is essential to the relevance and impact of patient-focused research. However, specific techniques for generating patient and community-informed research decisions remain limited. Here, we describes a novel CASCADE method (Community-Engaged Approach for Scientific Collaborations and Decisions) that was developed and implemented to make actionable, patient-centered research decisions during a federally funded clinical trial. Methods: The CASCADE approach includes 7 key pillars: (1) identifying a shared, specific, and actionable goal; (2) centering community input; (3) integrating both pre-registered statistical analyses and exploratory "quests"; (4) fixed-pace scheduling, supported by technology; (5) minimizing opportunities for cognitive biases typical to group decision making; (6) centering diversity experiences and perspectives, including those of individual patients; (7) making decisions that are community-relevant, rigorous, and feasible. Here, we implemented these pillars within a three-day CASCADE panel, attended by diverse members of a research project team that included community interest-holders. The goal of our panel was to identify ways to improve an algorithm for matching patients to specific types of telehealth programs within an active, federally funded clinical trial. Results: The CASCADE panel was attended by 27 participants, including 5 community interest-holders. Data reviewed to generate hypotheses and make decisions included (1) pre-registered statistical analyses, (2) results of 12 "quests" that were launched during the panel to answer specific panelist questions via exploratory analyses or literature review, (3) qualitative and quantitative patient input, and (4) team member input, including by staff who represented the target patient population for the clinical trial. Panel procedures resulted in the generation of 18 initial and 12 final hypotheses, which were translated to 19 decisional changes. Conclusions: The CASCADE approach was an effective procedure for rapidly, efficiently making patient-centered decisions during an ongoing, federally funded clinical trial. Opportunities for further development will include exploring best-practice structural procedures, enhancing greater opportunities for pre-panel input by community interest-holders, and determining how to best standardize CASCADE outputs. Trial registration: The CASCADE procedure was developed in the context of NCT05999448.

Implementation of guideline-directed medical therapy for heart failure patients with reduced ejection fraction in Belgium: a Delphi panel approach.

BACKGROUND: The 2021 European Society of Cardiology (ESC) guidelines recommended a shift from a traditional hierarchical treatment for heart failure with reduced ejection fraction (HFrEF) to a four-pillar medical therapy strategy intended for near-simultaneous initiation. However, practical guidance for implementation in clinical practice is lacking. To address this, a Delphi Panel of 12 Belgian heart failure experts aimed to obtain consensus on integrating guideline-directed medical therapy (GDMT) in HFrEF patients in Belgian clinical practice, considering local specificities, including reimbursement criteria. METHODS: A geographically representative sample of 12 Belgian cardiologists engaged in a three-round Delphi process, evolving from 20 open-ended questions to 39 statements. A qualitative analysis after the first round resulted in expert statements for the subsequent questionnaire, categorised into treatment for newly diagnosed and chronic HFrEF patients. RESULTS: The Delphi consensus revealed four key findings: (i) Agreement on initiating the four medical cornerstones within 7-14 days of HFrEF diagnosis, prioritising initiation over individual class up-titration; (ii) Lack of consensus on a fixed sequence for initiation due to patient variability and national reimbursement criteria; (iii) Emphasis on treatment adjustment based on the patient's clinical presentation and comorbidities; (iv) Recognition of the crucial role of regular follow-up visits, allowing optimisation of medical therapy where appropriate. CONCLUSION: This national Delphi consensus addresses clinical implementation of GDMT in HFrEF patients for Belgian cardiologists. The consensus highlights the importance of swift implementation of the four cornerstone medical therapies in newly diagnosed HFrEF patients, individualising treatment sequencing, and ensuring regular follow-up to optimise therapy.

Clinical consensus on treatments for transplant-ineligible newly diagnosed multiple myeloma: double-blinded Delphi panel.

Aim: Obtain clinical consensus on factors impacting first-line prescribing for transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM). Materials & methods: A double-blinded, modified Delphi panel was employed. USA-based hematologists/oncologists who treat TIE patients with NDMM were selected as expert panelists. Results: Consensus was reached that patient frailty, performance status, comorbidities, treatment efficacy, and adverse event profile affect first-line prescribing. All panelists agreed it is important to use the most efficacious treatment first; 88% of panelists considered daratumumab-containing regimens the most efficacious. Panelists agreed treatment should be continued until progression while benefits outweigh risk. Conclusion: Findings reinforce the importance of using the most efficacious regimen upfront for TIE NDMM, and nearly all panelists considered daratumumab-containing regimens the most efficacious treatment.

The purpose of this study was to determine the latest clinician preferences and opinions on factors affecting initial treatment selection for people recently diagnosed with multiple myeloma and unable to receive a bone marrow transplant, and to understand challenges with current treatments used in clinical practice. A panel of doctors with an average of two decades of experience treating blood disorders and cancers were recruited as expert panelists. Experts discussed treatment options by completing two rounds of surveys on treatment and one round of discussion. All experts agreed that the most effective treatment should be used first. Most experts considered treatment containing the drug daratumumab to be the most effective. Experts agreed that treatment should be continued until the cancer worsens if the treatment offers more benefits than side effects.

Recommendations to Improve Management of Incidental Pulmonary Nodules in Canada: Expert Panel Consensus.

Introduction: Incidental pulmonary nodules (IPN) are common radiologic findings, yet management of IPNs is inconsistent across Canada. This study aims to improve IPN management based on multidisciplinary expert consensus and provides recommendations to overcome patient and system-level barriers. Methods: A modified Delphi consensus technique was conducted. Multidisciplinary experts with extensive experience in lung nodule management in Canada were recruited to participate in the panel. A survey was administered in 3 rounds, using a 5-point Likert scale to determine the level of agreement (1 = extremely agree, 5 = extremely disagree). Results: Eleven experts agreed to participate in the panel; 10 completed all 3 rounds. Consensus was achieved for 183/217 (84.3%) statements. Panellists agreed that radiology reports should include a standardized summary of findings and follow-up recommendations for all nodule sizes (ie, <6, 6-8, and >8 mm). There was strong consensus regarding the importance of an automated system for patient follow-up and that leadership support for organizational change at the administrative level is of utmost importance in improving IPN management. There was no consensus on the need for standardized national referral pathways, development of new guidelines, or establishing a uniform picture archiving and communication system. Conclusion: Canadian IPN experts agree that improved IPN management should include standardized radiology reporting of IPNs, standardized and automated follow-up of patients with IPNs, guideline adherence and implementation, and leadership support for organizational change. Future research should focus on the implementation and long-term effectiveness of these recommendations in clinical practice.

Therapeutic strategies during cenobamate treatment initiation: Delphi panel recommendations.

The goal of epilepsy treatment is seizure freedom, typically with antiseizure medication (ASM). If patients fail to attain seizure control despite two trials of appropriately chosen ASMs at adequate doses, they are classified as having drug-resistant epilepsy (DRE). Adverse events (AEs) commonly occur in people with DRE because they are typically on ⩾2 ASMs, increasing the potential for drug-drug interactions. Early emerging AEs may impact adherence, decrease quality of life, and delay achieving optimal treatment dosages. Cenobamate is an oral ASM with a long half-life which has proven to be highly effective in clinical trials. An international Delphi panel of expert epileptologists experienced in the clinical use of cenobamate and other ASMs was convened to develop consensus best practices for managing patients during and after cenobamate titration, with consideration for its known pharmacokinetic and pharmacodynamic interactions, to allow patients to reach the most appropriate cenobamate dose while limiting tolerability issues. The modified Delphi process included one open-ended questionnaire and one virtual face-to-face meeting. Participants agreed that cenobamate can be prescribed for most patients experiencing focal-onset seizures. Patients initiating cenobamate therapy should have access to healthcare professionals as needed and their treatment response should be evaluated at the 100-mg dose. Patients with intellectual disabilities may need additional support to navigate the titration period. Proactive down-titration or withdrawal of sodium channel blockers (SCBs) is recommended when concomitant ASM regimens include ⩾2 SCBs. When applicable, maintaining a concomitant clobazam dose at ~5-10 mg may be beneficial. Patients taking oral contraceptives, newer oral anticoagulants, or HIV antiretroviral medications should be monitored for potential interactions. Because clinical evidence informing treatment decisions is limited, guidance regarding dose adjustments of non-ASM drugs was not developed beyond specific recommendations presented in the Summary of Product Characteristics.

Developing mental health curricula and a service provision model for clinical associates in South Africa: a Delphi survey of family physicians and psychiatrists.

BACKGROUND: Clinical associates are a health professional cadre that could be utilised in mental health task sharing in South Africa but this is training dependent. The objectives of the study were to identify the potential curricula content, training sites, and teaching modalities for undergraduate and potential postgraduate clinical associate mental health training and to identify the tasks that they should perform based on these curricula. METHODS: We utilised the Delphi method to reach consensus on items with the panel comprising psychiatrists and family physicians. The first round questionnaire of the Delphi survey was developed based on a literature review and the results from earlier phases of the overall study. The survey was administered electronically and consisted of three rounds. Following both the first and second rounds, an updated questionnaire was constructed omitting the items on which consensus was reached. The questionnaire consisted primarily of nine-point scales with consensus based on 70% of participants rating 1,2,3 or 7,8,9. RESULTS: There were 26 participants in the first round with this number falling to 23 in later rounds. There was strong consensus on a training attachment to a mental health clinic at a community health centre (CHC) at undergraduate (96.2%) and postgraduate level (100%). Consensus was reached on the importance of training on the management of six categories of disorders at the undergraduate level and nine categories of disorders at the postgraduate level. Clerking patients as a teaching modality reached 100% consensus at both undergraduate and postgraduate levels. PHC clinics, CHCs and district hospitals reached consensus as appropriate settings for clinical associates to provide mental health services. In addition, GP practices and secondary hospitals reached consensus for those with postgraduate training. Consensus was reached on ten of the 21 listed tasks that could be performed based on undergraduate training and 20 of the 21 tasks based on a postgraduate qualification in mental health. CONCLUSIONS: The Delphi panel's recommendations provide a clear roadmap for enhancing mental health curricula for clinical associates, enabling their utilisation in mental health service provision. A future postgraduate mental health qualification for clinical associates would allow for expanded task sharing.

Refining the CRiSPHe (checklist for reporting research using a simulated patient methodology in Health): a Delphi study.

OBJECTIVES: A recent applicability study highlighted the need for the existing checklist for reporting research using a simulated patient methodology (CRiSP) to be clearer and user-friendly. The aim of this study was to update the checklist to address these concerns. METHODS: A fourth round of the Delphi consensus study, used in the original checklist development work, was conducted. Previous participants, who had expertise in SP methodology, were invited to complete a questionnaire including a list of 13 checklist items developed in the previous study and revised following applicability testing. Closed questions were analysed for frequency. Consensus was predefined as >80% agreement. All items were discussed in a roundtable meeting and further modified as necessary. Responses to open questions were content analysed. KEY FINDINGS: Twenty-one authors participated. There was a statistical consensus in 12 out of 13 modified checklist items. CONCLUSIONS: A final reporting checklist for studies in health research using SP methodology has been developed using a consensus approach. Further refinements may be needed to increase the generalizability of the checklist in different contexts.

Facets of physical function assessed by patient-reported outcome measures in oncology research.

PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure. METHODS: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item. RESULTS: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation. CONCLUSION: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.

Identifying priority areas to support primary care engagement in breast cancer survivorship care: A Delphi study.

INTRODUCTION: Existing approaches in cancer survivorship care delivery have proven to be insufficient to engage primary care. This study aimed to identify stakeholder-informed priorities to improve primary care engagement in breast cancer survivorship care. METHODS: Experts in U.S. cancer survivorship care delivery were invited to participate in a 4-round online Delphi panel to identify and evaluate priorities for defining and fostering primary care's engagement in breast cancer survivorship. Panelists were asked to identify and then assess (ratings of 1-9) the importance and feasibility of priority items to support primary care engagement in survivorship. Panelists were asked to review the group results and reevaluate the importance and feasibility of each item, aiming to reach consensus. RESULTS: Respondent panelists (n = 23, response rate 57.5%) identified 31 priority items to support survivorship care. Panelists consistently rated three items most important (scored 9) but with uncertain feasibility (scored 5-6). These items emphasized the need to foster connections and improve communication between primary care and oncology. Panelists reached consensus on four items evaluated as important and feasible: (1) educating patients on survivorship, (2) enabling screening reminders and monitoring alerts in the electronic medical record, (3) identifying patient resources for clinicians to recommend, and (4) distributing accessible reference guides of common breast cancer drugs. CONCLUSION: Role clarity and communication between oncology and primary care were rated as most important; however, uncertainty about feasibility remains. These findings indicate that cross-disciplinary capacity building to address feasibility issues may be needed to make the most important priority items actionable in primary care.

Timing of proper introduction, optimization and maintenance of anti-TNF therapy in IBD: Results from a Delphi consensus.

BACKGROUND: Crohn's disease and ulcerative colitis are inflammatory bowel diseases (IBDs) with a rapidly growing worldwide incidence. The last decades presented rapid progress in pharmacological treatment leading in many cases to clinical and endoscopic remission, including biological treatment with anti-TNF agents. AIM: The exact timing of introduction, optimization and maintenance of anti-TNF therapy in IBDs is not thoroughly covered in current guidelines. METHODS: We used the Delphi panel methodology to gather the IBD experts' views and achieve consensus for clinical recommendations on introducing and maintaining anti-TNF therapy for patients with IBDs. RESULTS: Twelve recommendations achieved a high level of consensus in two assessment rounds by 52 (1st round) and 47 (2nd round) IBD experts. CONCLUSION: In many clinical situations, the early use of anti-TNF therapy is recommended. Nowadays, the cost-efficacy profile of anti-TNF biosimilars makes them the first-line drug in a substantial proportion of patients, thus providing the opportunity to increase access to biological therapy.

A Delphi approach to establishing consensus on best practice for the diagnosis and treatment of Demodex blepharitis.

Demodex blepharitis does not have agreed standardized guidelines. The aim of this study was to classify signs and symptoms and to develop appropriate management strategies for Demodex blepharitis from a consensus of expert advice. METHODS: A total of 11 anterior segment experts (ophthalmologists, optometrists and a contact lens optician) working in the United Kingdom participated in a modified 2-round Delphi panel. A mixed-methods approach was adopted and a survey questionnaire for round 1 was formulated, constructed from information in the available literature. Based on panel responses from round 1, feedback was provided and a round 2 questionnaire was formulated. More than two-thirds majority (72%) was used for consensus building. RESULTS: Based on the clinical presentation of signs and symptoms along with associated conditions and risk factors, a diagnostic algorithm was proposed for the clinical investigation of Demodex blepharitis. A treatment algorithm was also proposed with first-line and second-line treatment recommendations for Demodex blepharitis. CONCLUSION: The recommendation from this study provides the first effort in formulating clinical diagnostic algorithm and management guidelines for Demodex blepharitis. The guidelines include appropriate magnification on the slit lamp, associated signs, symptoms, risk factors and suggested management options. These guidelines can be used in a routine eyecare setting to encourage eyecare practitioners in tailoring the investigation and management of Demodex blepharitis.

International consensus for a dissection room quality system (DRQS): A Delphi panel study.

Dissection Rooms (DRs) are key facilities that allow teaching and research on human anatomy, where students and researchers work with human bodies to acquire, increase, or create new knowledge. Usually, DRs work with a Body Donation Program (BDP), where living donors bequeath their bodies for use in teaching and research after they expire. Despite DRs being part of universities worldwide, no common guidelines, regulations, or quality management systems (QMS) exist that could be applied to different countries. With that purpose in mind, we aimed to develop a QMS that could be applied to DRs globally, using a Delphi panel to achieve consensus about the items that should constitute the QMS. The panel was constituted by 20 anatomy professors from 20 different countries, and the 167 standards to create the rules or guidelines that constitute the QMS were divided in five categories: direction, body donation, students, instructors, and research. After two rounds of revisions, 150 standards were considered "essential" or "important" by more than 70% of the participants, thus being incorporated to the Dissection Room Quality System (DRQS). The results of this panel represent a minimum list of items of the DRQS for improving the functioning of DRs globally.

Implementation measurement in global mental health: Results from a modified Delphi panel and investigator survey.

Limited guidance exists to support investigators in the choice, adaptation, validation and use of implementation measures for global mental health implementation research. Our objectives were to develop consensus on best practices for implementation measurement and identify strengths and opportunities in current practice. We convened seven expert panelists. Participants rated approaches to measure adaptation and validation according to appropriateness and feasibility. Follow-up interviews were conducted and a group discussion was held. We then surveyed investigators who have used quantitative implementation measures in global mental health implementation research. Participants described their use of implementation measures, including approaches to adaptation and validation, alongside challenges and opportunities. Panelists agreed that investigators could rely on evidence of a measure's validity, reliability and dimensionality from similar contexts. Panelists did not reach consensus on whether to establish the pragmatic qualities of measures in novel settings. Survey respondents (n = 28) most commonly reported using the Consolidated Framework for Implementation Research Inner Setting Measures (n = 9) and the Program Assessment Sustainability Tool (n = 5). All reported adapting measures to their settings; only two reported validating their measures. These results will support guidance for implementation measurement in support of mental health services in diverse global settings.

Interim guidelines for the assessment and treatment of pain in children with multiple sclerosis.

Introduction: Pain in multiple sclerosis (MS) is common, but literature on pain in children with MS remains scarce. Pain has physical, psychological, and social implications in MS, and both comprehensive assessment and interdisciplinary management approaches are needed. We sought to develop an interdisciplinary interim guideline for the assessment and management of pain in children with MS. Methods and materials: We convened a modified Delphi panel composed of 13 experts in pediatric and adult MS neurology, physiotherapy, pain, patient lived-experience, advanced practice nursing, psychology, physiatry, and MS research. A survey was sent to panelists for anonymous completion. The panel discussed survey themes extracted by the panel chair. The process was repeated twice. Results: Thirteen assessment and treatment recommendations were produced regarding pain in children with MS. Discussion: Future studies will assess implementation of these pain assessment and treatment guidelines in the clinical setting.

Management of amyotrophic lateral sclerosis in clinical practice: Results of the expert consensus using the Delphi methodology.

Amyotrophic lateral sclerosis (ALS) is a rare disease characterized by a progressive and irreversible degeneration of upper and lower motor neurons leading to death. In France, limited data exist describing the criteria used in clinical practice for diagnosis and follow-up, and how novel therapies may fit in. The objective of this Delphi panel was to obtain an overview of current French practices in ALS diagnosis, management, and follow-up by determining the scales and criteria used in clinical practice outside of clinical trials, as well as the place of a future treatment like AMX0035, acting on endoplasmic reticulum (ER) stress and mitochondrial dysfunction, in the current therapeutic strategies. A questionnaire was administered to 24 ALS healthcare providers practicing in ALS centers in France. Two rounds of remote voting were organized, before proposition of final consensus statements. Consensus was considered reached when at least 66% of the voters agreed. Consensus were obtained to define the new Gold Coast criteria as the ones used in clinical practice to establish the diagnosis of ALS, thus replacing the revised El Escorial criteria, considered too complex and now mainly used to characterize the patient populations to be included in clinical trials. The clinical factors considered to establish ALS diagnosis are mainly the demonstration of progression of the motor deficit and elimination of differential diagnoses. The ALSFRS-R scale is used in daily clinical practice to assess patient's functional impairment in terms of number of points lost, with the bulbar, respiratory, and fine motor subscores being the most important to evaluate independently. A critical medical need was identified regarding the provision of new therapeutic alternatives in ALS. The panel members would support the earliest management of patients. In this landscape, based on data from a very encouraging phase II (Centaur trial), AMX0035 represents a new tool of choice in current treatment strategies for all patients for whom experts are confident in the diagnosis of ALS, in combination with riluzole. These results will need to be confirmed by the ongoing phase III trial (Phoenix trial).

Diagnosis and referral of patients with AL amyloidosis in Portugal: results from a Delphi panel.

Light chain amyloidosis (AL) is a complex disorder defined by the extracellular deposition of insoluble amyloid fibrils formed by intact or fragmented immunoglobulin light chains, leading to cell dysfunction, rapid organ deterioration, and, ultimately, death. Although the clinical presentation of AL is directly connected to organ involvement, signs and symptoms of AL are frequently nonspecific, misinterpreted, and late recognized. Thus, an early diagnosis combined with effective therapies to cease disease progression and rescue organ function is essential. The aim of this study was to assess the knowledge and characterize the current clinical practice regarding AL diagnosis and referral among Portuguese physicians. A Delphi-like panel (one round only) with a group of national experts from different medical specialties (cardiology, hematology, internal medicine, nephrology, and neurology) was carried out online, in which 30 statements were classified using a 4-point Likert scale. For each statement, the consensus level was set at 70% for "fully agree/disagree" and the majority level was defined as >70% in agreement or disagreement. Although the results suggest the existence of adequate general knowledge of AL amyloidosis, they also disclosed the necessity to raise awareness for this disease. Overall, this Delphi panel revealed a high lack of consensus regarding the diagnosis and early management of patients with AL among different specialties despite the qualified majority obtained in 26 statements. An optimized strategy for AL early diagnosis, transversal to several medical fields, is urgently needed. Moreover, referral centers with access to diagnostic technology and a network of diverse specialties should be established to foster an early diagnosis and better disease approach to boost the possibility of a better outcome for patients with AL.

Expert UK consensus on the definition of high risk of recurrence in HER2-negative early breast cancer: A modified Delphi panel.

BACKGROUND: There is currently no standardised definition for patients at high risk of recurrence of human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC; stages 1-3) after surgery. This modified Delphi panel aimed to establish expert UK consensus on this definition, separately considering hormone receptor (HR)-positive and triple-negative (TN) patients. METHODS: Over three consecutive rounds, results were collected from 29, 24 and 22 UK senior breast cancer oncologists and surgeons, respectively. The first round aimed to determine key risk factors in each patient subgroup; subsequent rounds aimed to establish appropriate risk thresholds. Consensus was pre-defined as ≥70% of respondents. RESULTS: Expert consensus was achieved on need to assess age, tumour size, tumour grade, number of positive lymph nodes, inflammatory breast cancer and risk prediction tools in all HER2-negative patients. There was additional agreement on use of tumour profiling tests and biomarkers in HR-positive patients, and pathologic complete response (pCR) status in TN patients. Thresholds for high recurrence risk were subsequently agreed. In HR-positive patients, these included age <35 years, tumour size >5 cm (as independent risk factors); tumour grade 3 (independently and combined with other high-risk factors); number of positive nodes ≥4 (independently) and ≥1 (combined). For TN patients, the following thresholds reached consensus, both independently and in combination with other factors: tumour size >2 cm, tumour grade 3, number of positive nodes ≥1. CONCLUSIONS: The results may be a valuable reference point to guide recurrence risk assessment and decision-making after surgery in the HER2-negative eBC population.

Global Surgeon Opinion on the Impact of Surgical Access When Using Endocutters Across Specialties.

Background: Despite design enhancements in endocutters, key challenges related to limited surgical access and space can impact stapling and, potentially, surgical outcomes. Objectives: This study aimed to develop consensus statements outlining the clinical value of precise articulation and greater anatomical access in minimally invasive surgery performed by bariatric, colorectal, and thoracic surgeons. Methods: Colorectal, bariatric, and thoracic surgeons from Japan, the United States, United Kingdom, and France participated in a 2-round modified Delphi panel. Round 1 included binary, Likert scale-type, multiple-response, and open-ended questions. These were converted to affirmative statements for round 2 if sufficient agreement was reached. Consensus was set at a predefined threshold of at least 90% of panelists across all surgical specialties and regions selecting the same option ("agree" or "disagree") for the affirmative statements. Results: Of the 49 statements in the round 2 questionnaire, panelists (n=135) reached consensus that (1) tissue slippage outside stapler jaws can occur due to limited access and space; (2) greater jaw aperture could help to manipulate thick or fragile tissue more easily; (3) articulation of an endocutter is clinically important in laparoscopic surgeries; (4) improved access to hard-to-reach targets and in limited space would improve safety; and (5) an endocutter with improved access through greater articulation would become common use. Discussion: By understanding user-specific challenges and needs from both specialty- and region-wide perspectives, endoscopic stapling devices can continue to be refined. In this study, improved articulation and greater jaw aperture were the key design features examined. Improved articulation and greater jaw aperture were key stapler design features identified in this study that may mitigate the risk of instrument clashes and intraoperative complications such as anastomotic leaks. Conclusions: This study gained insights into surgeons' perspective across a variety of specialties and from 3 distinct geographies. Participating surgeons reached consensus that an endocutter with greater jaw aperture and articulation may improve surgical access and has potential to improve surgical outcomes.

Current treatment landscape of HR+/HER2- advanced breast cancer in the Nordics: a modified Delphi study.

BACKGROUND: This Delphi study aimed to assess current perspectives on hormone receptor-positive/human epidermal growth factor receptor 2-negative(HR+/HER2-) advanced breast cancer (aBC) treatment strategies across the Nordics, and to establish where consensus exists across the Nordics on HR+/HER2- aBC treatment. MATERIAL AND METHODS: A modified, three-round Delphi method was followed. A steering committee was appointed for study coordination, panellist selection, and questionnaire development. The questionnaires covered relevant topics on HR+/HER2- aBC treatment: treatment patterns in different lines of therapy (first [1L], second [2L], and third [3L]), oligometastatic disease, de novo aBC, brain metastases, age as influential factor, visceral crisis, radiotherapy, diagnostics, and clinical guidelines. Both open and closed-ended questions were included. Consensus was defined as at least 70% agreement. RESULTS: In total, 28 experienced BC oncologists participated in the study from all five Nordic countries. Overall, topics reaching consensus included: preferred treatment approach in 1L and 2L therapy, treatment of oligometastatic disease, visceral crisis, brain metastases, and age-related treatment considerations. No consensus was reached for 3L therapy and local treatment for primary tumour in de novo aBC. Endocrine therapy (ET) combined with a cyclin-dependent kinase (CDK)4/6 inhibitor was the treatment of choice for 1L and 2L therapy. Treatment patterns in clinical practice did not always follow recommendations in current Nordic guidelines, as seen in the case of recently approved treatments. DISCUSSION: ET in combination with a CDK4/6 inhibitor is the preferred frontline treatment for HR+/HER2- aBC in the Nordics. The observed discrepancy between current guidelines and clinical practice could be due to differences in the reimbursement of novel treatments in the Nordics. Collaborative research efforts are warranted for topics that lack consensus.

U-CHANGE Project: a multidimensional consensus on how clinicians, patients and caregivers may approach together the new urothelial cancer scenario.

Introduction: Advanced urothelial carcinoma remains aggressive and very hard to cure, while new treatments will pose a challenge for clinicians and healthcare funding policymakers alike. The U-CHANGE Project aimed to redesign the current model of care for advanced urothelial carcinoma patients to identify limitations ("as is" scenario) and recommend future actions ("to be" scenario). Methods: Twenty-three subject-matter experts, divided into three groups, analyzed the two scenarios as part of a multidimensional consensus process, developing statements for specific domains of the disease, and a simplified Delphi methodology was used to establish consensus among the experts. Results: Recommended actions included increasing awareness of the disease, increased training of healthcare professionals, improvement of screening strategies and care pathways, increased support for patients and caregivers and relevant recommendations from molecular tumor boards when comprehensive genomic profiling has to be provided for appropriate patient selection to ad hoc targeted therapies. Discussion: While the innovative new targeted agents have the potential to significantly alter the clinical approach to this highly aggressive disease, the U-CHANGE Project experience shows that the use of these new agents will require a radical shift in the entire model of care, implementing sustainable changes which anticipate the benefits of future treatments, capable of targeting the right patient with the right agent at different stages of the disease.