European Expert Panel Research Articles

The contributions of university chaplains, as spiritual care professionals, to suicide prevention: results from a European expert panel

ABSTRACT University chaplains are responsible for providing spiritual care to all members of the university community. Within the multifaceted duties of a university chaplain, one crucial (yet often overlooked) aspect is suicide prevention. To identify the contributions of university chaplains to suicide prevention, seven university chaplains located in four European countries participated in three focus group sessions. Two overarching themes were generated from the focus group sessions: key elements of university chaplaincy; and the contributions of university chaplains to suicide prevention. The study revealed that university chaplains contribute to all three phases of suicide prevention: prevention, intervention, and postvention.

Radiofrequency for chronic lumbosacral and cervical pain: Results of a consensus study using the RAND/UCLA appropriateness method.

Despite the routine use of radiofrequency (RF) for the treatment of chronic pain in the lumbosacral and cervical region, there remains uncertainty on the most appropriate patient selection criteria. This study aimed to develop appropriateness criteria for RF in relation to relevant patient characteristics, considering RF ablation (RFA) for the treatment of chronic axial pain and pulsed RF (PRF) for the treatment of chronic radicular pain. The RAND/UCLA Appropriateness Method (RUAM) was used to explore the opinions of a multidisciplinary European panel on the appropriateness of RFA and PRF for a variety of clinical scenarios. Depending on the type of pain (axial or radicular), the expert panel rated the appropriateness of RFA and PRF for a total of 219 clinical scenarios. For axial pain in the lumbosacral or cervical region, appropriateness of RFA was determined by the dominant pain trigger and location of tenderness on palpation with higher appropriateness scores if these variables were suggestive of the diagnosis of facet or sacroiliac joint pain. Although the opinions on the appropriateness of PRF for lumbosacral and cervical radicular pain were fairly dispersed, there was agreement that PRF is an appropriate option for well-selected patients with radicular pain due to herniated disc or foraminal stenosis, particularly in the absence of motor deficits. The panel outcomes were embedded in an educational e-health tool that also covers the psychosocial aspects of chronic pain, providing integrated recommendations on the appropriate use of (P)RF interventions for the treatment of chronic axial and radicular pain in the lumbosacral and cervical region. A multidisciplinary European expert panel established patient-specific recommendations that may support the (pre)selection of patients with chronic axial and radicular pain in the lumbosacral and cervical region for either RFA or PRF (accessible via https://rftool.org). Future studies should validate these recommendations by determining their predictive value for the outcomes of (P)RF interventions.

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.

Providing quality care for people with CDKL5 deficiency disorder: A European expert panel opinion on the patient journey.

Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) is a developmental and epileptic encephalopathy caused by variants in the CDKL5 gene. The disorder is characterized by intractable early-onset seizures, severe neurodevelopmental delay, hypotonia, motor disabilities, cerebral (cortical) visual impairment and microcephaly. With no disease-modifying therapies available for CDD, treatment is symptomatic with an initial focus on seizure control. Another unmet need in the management of people with CDD is the lack of evidence to aid standardized care and guideline development. To address this gap, experts in CDD and representatives from patient advocacy groups from Denmark, Finland, France, Germany, Italy, Poland, Spain, and the United Kingdom convened to form an Expert Working Group. The aim was to provide an expert opinion consensus on how to ensure quality care in routine clinical practice within the European setting, including in settings with limited experience or resources for multidisciplinary care of CDD and other developmental and epileptic encephalopathies. By means of one-to-one interviews around the current treatment landscape in CDD, insights from the Expert Working Group were collated and developed into a Europe-specific patient journey for individuals with CDD, which was later validated by the group. Further discussions followed to gain consensus of opinions on challenges and potential solutions for achieving quality care in this setting. The panel recognized the benefit of early genetic testing, a holistic personalized approach to seizure control (taking into consideration various factors such as concomitant medications and comorbidities), and age- and comorbidity-dependent multidisciplinary care for optimizing patient outcomes and quality of life. However, their insights and experiences also highlighted much disparity in management approaches and resources across different European countries. Development of standardized European recommendations is required to align realistic diagnostic criteria, treatment goals, and management approaches that can be adapted for different settings. PLAIN LANGUAGE SUMMARY: Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) is a rare condition caused by a genetic mutation with a broad range of symptoms apparent from early childhood, including epileptic seizures that do not respond to medication and severe delays in development. Due to the lack of guidance on managing CDD, international experts and patient advocates discussed best practices in the care of people with CDD in Europe. The panel agreed that early testing, a personalized approach to managing seizures,and access to care from different disciplines are beneficial. Development of guidelines to ensure that care is standardized would also be valuable.

Management of ALL in adults: 2024 ELN recommendations from a European expert panel

AbstractExperts from the European Leukemia Net (ELN) working group for adult acute lymphoblastic leukemia have identified an unmet need for guidance regarding management of adult acute lymphoblastic leukemia (ALL) from diagnosis to aftercare. The group has previously summarized their recommendations regarding diagnostic approaches, prognostic factors, and assessment of ALL. The current recommendation summarizes clinical management. It covers treatment approaches, including the use of new immunotherapies, application of minimal residual disease for treatment decisions, management of specific subgroups, and challenging treatment situations as well as late effects and supportive care. The recommendation provides guidance for physicians caring for adult patients with ALL which has to be complemented by regional expertise preferably provided by national academic study groups.

Diagnosis, prognostic factors, and assessment of ALL in adults: 2024 ELN recommendations from a European expert panel

AbstractWorking groups of the European LeukemiaNet have published several important consensus guidelines. Acute lymphoblastic leukemia (ALL) has many different clinical and biological subgroups and the knowledge on disease biology and therapeutic options is increasing exponentially. The European Working Group for Adult ALL has therefore summarized the current state of the art and provided comprehensive consensus recommendations for diagnostic approaches, biologic and clinical characterization, prognostic factors, and risk stratification as well as definitions of endpoints and outcomes. Aspects of treatment, management of subgroups and specific situations, aftercare, and supportive care are covered in a separate publication. The present recommendation intends to provide guidance for the initial management of adult patients with ALL and to define principles as a basis for future collaborative research.

Expert Revision of Key Elements for Clinical-Grade Production and Qualification of Perinatal Derivatives.

Perinatal derivatives have been proposed as adjunct therapeutic strategies or innovative treatments. Undoubtedly, perinatal derivatives can offer the opportunity and source material to isolate multipotent stem cells, but both maternal- and fetal-derived tissues can be processed and transformed into engineered tissues or advanced biomedical devices, whose potential remains to be fully elucidated. Promising preclinical and clinical results collected so far clearly foresee an escalation of such novel treatments. Market forecasts predict exponential growth in such advanced medicinal products during the next decade, with a pragmatic innovation for medicine into a more advanced biomedical version, enlarging the portfolio for treating a wide range of congenital and acute conditions. However, all these promising and fascinating therapeutic possibilities cannot gain a solid and recognized role in established medical practice without rigid and harmonized manufacturing strategies. The implementation of strategies according to guidelines and directives compiled by Regulatory Agencies, in conformity to (European) Pharmacopoeia and for Good Manufacturing Practice -conforming production of such products, represent critical steps required to translate perinatal technologies into effective therapeutic approaches. During the past 5 years, a panel of European experts and developers, gathered under the umbrella of the COST Sprint Action, supported by the European Cooperation in Science and Technology action, had the opportunity to revise and summarize experience and recommendations for a fruitful and proficient generation of perinatal biomedical products. In order to facilitate the creation and potential commercialization of perinatal bioengineered and advanced pharmaceutical products and technologies, such a collection of data and recommendations is described and discussed here.

A minimum specification dataset for liquid ocular endotamponades: recommendations by a European expert panel

PurposeTo propose a minimum specification dataset to characterize liquid ocular endotamponades (OEs), namely silicone oil (SO), heavy SO (HSO), perfluorodecalin (PFD), and perfluoro-octane (PFO), in terms of physicochemical properties, purity and available evidence of safety, in line with ISO16672:2020.MethodsAn evidence-based consensus using the expert panel technique was conducted. Two facilitators led a committee of 11 European experts. Facilitators prepared a dataset for each compound including the list of specifications relevant for the safety, identified by the group members on the basis of expertise and a comprehensive literature review. Each item was ranked by each member using a 9-point scale from 1 “absolutely to not include” to 9 “absolutely to include” in two rounds followed by discussion. Only items reaching consensus (score ≥ 7 from ≥ 75% of members) were included in the final datasets.ResultsFor all OEs, consensus was reached to include manufacturer, density, refractive index, chemical composition, dynamic viscosity, interfacial and surface tension, endotoxins, in vitro cytotoxicity assessment, and any evidence from ex vivo and/or in vivo tests for safety assessment. Additional specifications were added for SO (molecular weight distribution, content of oligosiloxanes with MW ≤ 1000 g/mol, spectral transmittance) and PFD/PFO (% of pure PFD/PFO in the final product, vapor pressure, chemical analyses performed for safety assessment).ConclusionThe proposed evidence-based minimum specification datasets for SO, HSO, PFD, and PFO have the potential to provide surgeons and health service purchasers with an easily available overview of the most relevant information for the safety assessment of OEs.

Microcosting Analysis of Hematopoietic Stem Cell Transplantation and Chemotherapy with Intermediate Doses of Cytarabine in the Treatment of Acute Myeloid Leukemia

Adult patients with Acute Myeloid Leukemia (AML) are stratified according to clinical and laboratory features at diagnosis into favorable-, intermediate-, or unfavorable-risk groups and may be treated differently according to risk. The European LeukemiaNet panel of experts' recommendation for the post-induction treatment of the favorable subgroup is either chemotherapy with intermediate doses of cytarabine (IDAC, e.g. 1.5 g/m2 q12h for 3 days) or autologous hematopoietic stem-cell transplantation (auto-HSCT). Both alternatives are costly and few studies have compared health economics aspects, which are particularly relevant in source-restrained regions. Moreover, AML treatment in low- and middle-income countries was associated with a higher frequency of invasive fungal diseases (IFD) and infections by multi-resistant bacteria compared to high-income countries and this may directly affect the treatment cost. Studies comparing IFD incidence in patients with hematological malignancies showed lower rates in patients treated with auto-HSCT compared to intensive chemotherapy. Material & Methods: we performed the micro-costing analysis patients with intermediate-risk AML who received auto-HSCT (n=5) or IDAC (n=4) as post-induction treatment at University of Sao Paulo Hospital, Ribeirao Preto, Brazil. For cost analysis, we collected information about all resources and services consumed by patients such as medicines, materials, laboratory analysis, units of blood transfusion components, apheresis, hospital admissions, and outpatient care, in the period that began on the date of diagnosis until the end of treatment. The two groups had similar clinical and laboratorial characteristics at diagnosis and were treated according to the ICAML2015 protocol, in which induction (ID-1) is based on daunorubicin + standard-dose cytarabine (‘3+7‘), followed by a second cycle (ID-2) with daunorubicin + IDAC and, for those patients that achieved CR, consolidation was done with two cycles of IDAC (CONS-1 and CONS-2) or one cycle of IDAC followed by auto-HSCT (CONS-1 and auto-HSCT). The choice between the two alternatives of post-induction regimens was pre-defined by the participating center of the ICAML2015 study. Results: the mean cost of auto-HSCT and IDAC was US$ 4,188.12 and 2,368.22, respectively. Patients who received auto-HSCT stayed longer in-hospital compared to those in the IDAC group (21.8 versus 12.5 days). When the whole treatment is analyzed, the mean cost of the treatment with four cycles of chemotherapy was US$ 121,980.93 and that with three cycles followed by auto-HSCT was US$ 84,619.16. The most costly phase of treatment was the ID-1 (US$ 9,690.10). Regardless of the type of treatment, we observed that the inputs with the greatest economic impact were hospital admissions, which represented 51.2% of the total costs. . The second input with the greatest economic impact was drugs, and in that regard, treatment of infections played an important role in increasing the use of supplies in general. All patients in the study had febrile neutropenia that required hospital admission. Three patients were treated for IFD episodes, all of them were considered to be probable according to the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group, and the most frequently used antifungals were amphotericin B (deoxycholate) and voriconazole. All patients received prophylaxis with fluconazole. The frequency of IFD considering the whole treatment was 19.4 % (7/36 episodes of febrile neutropenia) and, there was no significant difference between patients who received auto-HSCT or IDAC. In conclusion, our results show that the cost of the post-induction treatment using auto-HSCT was higher than with IDAC and that cost with hospital stay.

Real-World Data for FLT3-Mutated Acute Myeloid Leukemia Patients Treated in Resource-Constrained Settings

Background: Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) is a well-established prognostic marker in acute myeloid leukemia (AML), whereas the impact of mutations in the Tirosine-Kinase Domain (TKD) is controversial. The association of TK inhibitors (TKIs) with intensive chemotherapy improved the overall survival (OS) of FLT3-mutated AML patients in randomized clinical trials and is recommended by the European LeukemiaNet panel of experts. Nevertheless, TKIs are not available for most patients treated in Low- and Middle-Income Countries (LMIC) and there is a scarcity of data concerning the outcome of treatment in these resource-constrained settings nowadays. Methods: This is a real-world study encompassing newly diagnosed adults with FLT3-mutated AML intensively treated at public hospitals in Brazil between January 2015 and December 2020, who were registered in the International Consortium on Acute Leukemias (ICAL) ICAML2015 Study. No patient received TKIs as part of the treatment. FLT3 mutation was tested in diagnostic samples by fragment analysis method. We used the Adapted Genetic Risk (AGR) score reported by Silveira et al. (2020), which is an adaptation of the European Leukemia Net (ELN) 2017 classification. The primary endpoints were event-free survival (EFS) and OS, calculated by Kaplan-Meier method. Relapse rate was calculated through competing risk analysis. Results: Overall, 350 pts (median age: 51y; 52.8% females) were included. FLT3-ITD and -TKD mutations were detected in 17.5% and 7.2% of the patients, respectively. Ninety patients (35.1%) were classified in the favorable risk group, 110 (42.9%) in the intermediate, and 56 (21.9%) in the adverse risk group, according to the AGR. The most frequent co-mutation was in the NPM1 gene. The remaining features are summarized in Table 1. Seventy-eight patients underwent allogeneic stem-cell transplantation (HSCT) in first complete remission (22.2%), of whom 27 had FLT3-ITD (i.e. 43.9% of patients harboring FLT3-ITD underwent HSCT). With a median follow-up period of 3.5 years, the median 4-year OS rate was 24.2% (95% CI 19.8-30.1), and the 4-y EFS 22.9% (95% CI 18.6-28.2). When only patients with FLT3-ITD mutations were analyzed, the 4-y OS rate was 14.4% which was inferior to that of patients with wild-type FLT3 (27.5%; p=0.057) (Figure 1). The cumulative incidence of relapse at four years was 39.4% for patients with FLT3-ITD and 43.9% for those with wildtype FLT3 (p=0.5), while the non-relapse mortality (NRM) at four years was 28.1% and 32.4%, respectively. The four-year OS rate for patients with FLT3-ITD mutations who underwent HSCT was 49.1% (95% CI 38.9-62.1). Patients with FLT3-ITD were further subdivided according to the allelic ratio (AR) in those with low (<0.5) and high (³ 0.5), and no significant difference in OS was detected between the two groups. Of note that patients harboring FLT3-TKD mutations showed a better overall survival rate compared to those with wild-type FLT3 (HR 0.49, 95% CI 0.26-0.93, p=0.029), but this result needs to be interpreted cautiously due the small size of the cohort. Conclusion: our results show that the frequency of FLT3-ITD mutations and their association with worse prognosis was similar to those described in high-income countries previously to the introduction of TKI as the standard of care. Therefore, allogeneic HSCT remains a valid consolidation strategy for FLT3-mutated patients. However, less than half of the patients for whom HSCT was indicated were actually transplanted. Additionally, the allelic ratio of FLT3-ITD should no longer be considered a prognostic marker for intensively treated patients not receiving FLT3 inhibitors.

Smart e-Skin Cancer Care in Europe During and after the Covid-19 Pandemic: a Multidisciplinary Expert Consensus.

Melanoma is the deadliest of all the skin cancers and its incidence is increasing every year in Europe. Patients with melanoma often present late to the specialist and treatment is delayed for many reasons (delay in patient consultation, misdiagnosis by general practitioners, and/or limited access to dermatologists). Beyond this, there are significant inequalities in skin cancer between population groups within the same country and between countries across Europe. The emergence of the COVID-19 pandemic only aggravated these health deficiencies. The aim was to create an expert opinion about the challenges in skin cancer management in Europe during the post COVID-19 acute pandemic and to identify and discuss the implementation of new technologies (including e-health and artificial intelligence defined as "Smart Skin Cancer Care") to overcome them. For this purpose, an ad-hoc questionnaire with items addressing topics of skin cancer care was developed, answered independently and discussed by a multidisciplinary European panel of experts comprising dermatologists, dermato-oncologists, patient advocacy representatives, digital health technology experts, and health technology assessment experts. After all panel of experts discussions, a multidisciplinary expert opinion was created. As a conclusion, the access to dermatologists is difficult and will be aggravated in the near future. This fact, together with important differences in Skin Cancer Care in Europe, suggest the need of a new approach to skin health, prevention and disease management paradigm (focused on integration of new technologies) to minimize the impact of skin cancer and to ensure optimal quality and equity.

1st EFORT European Consensus "Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices": Background, Delphi Methodology & Consensus process.

The objectives of the 1st EFORT European Consensus on 'Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices' were foremost to focus on patient safety by establishing performance requirements for medical devices. The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel. Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745. Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 'Introduction of Innovation' recommendations and a related survey. A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements. A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge. The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities. For the first time, initiated by the EFORT IPSI (WG1 'Introduction of Innovation'), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.

99mTc-Tilmanocept performance for sentinel node mapping in breast cancer, melanoma, and head and neck cancer: a systematic review and meta-analysis from a European expert panel.

Although multiple radiopharmaceuticals are currently available for sentinel node (SN) biopsy, 99mTc-tilmanocept is of particular interest due to its low molecular weight and specific binding capability for the mannose receptors of lymphatic reticuloendothelial cells. In the current systematic review and meta-analysis, we aimed to provide an update from a European expert panel on the performance of 99mTc-tilmanocept for SN biopsy. A systematic literature search of the PubMed/Medline and Embase databases was performed to identify studies on the use of 99mTc-tilmanocept for SN identification in oncological patients. The articles' methodological quality was assessed before inclusion. The pooled estimates of the pre-/intraoperative detection rates (DR; proportion of patients with ≥ 1 SN identified) and/or pN + sensitivity (SN + /pN + patients ratio), with 95% confidence intervals (CIs), were calculated for breast cancer, melanoma, and head and neck cancer. Twenty-four articles were included in the systematic review, and twenty-one provided data for the meta-analysis. According to data availability, the 99mTc-tilmanocept-estimated pooled preoperative and intraoperative DRs were 0.94 (95%CI, 0.88-1.01) and 0.99 (0.98-1.00) for breast cancer, 0.98 (0.96-0.99) and 1.00 (0.99-1.00) for melanoma, and 0.97 (0.93-1.02) and 0.99 (0.96-1.01) for head and neck carcinoma. Finally, the pooled sensitivity for nodal metastasis in melanoma was 0.97 (95% CI, 0.92-1.03). 99mTc-tilmanocept is a promising radiotracer for SN mapping in patients with breast cancer, melanoma, or head and neck cancer. We strongly believe that multicenter trials are still needed to assess if 99mTc-tilmanocept is superior to other radiotracers used in clinical routine.

Predictors of response to radiation therapy and of progression to multiple myeloma in patients with solitary bone and extramedullary plasmacytomas

Introduction: Radiation therapy (RT) plays an important role in treating Solitary Extramedullary (EMP) and Solitary Bone (SBP) Plasmacytomas. The objective of this study is to review the effectiveness of RT in locally controlling the disease and looking at factors that predict progression to Multiple Myeloma (MM) in the PET scan-era. Methods: We performed a retrospective analysis of consecutive plasmacytoma patients (pts) treated at our high-volume center. We identified 94 pts, of which 62 were diagnosed with SBP and 32 with EMP, without evidence of MM at diagnosis (end-organ damage, >10% bone marrow involvement, >1 plasmacytoma). We identified 94 total pts, largest series to date in the literature, treated with RT (no pts received systemic therapy) between January 1, 2000, through December 31, 2020. Of the 94 pts, 62 were diagnosed with SBP and 32 with EMP, without evidence of MM at diagnosis (end-organ damage, >10% bone marrow involvement, >1 plasmacytoma). We utilized radiographic staging including PET scans and clinical assessments to determine patient outcomes. Outcomes include initial radiographic responses using the European Expert Panel Response Criteria, local control (LC), overall survival (OS), and progression to MM. Kaplan-Meier was used to assess LC and OS. Univariable analysis was done using age, sex, race, plasmacytoma type (EMP vs. SBP), PET scan at staging versus other modalities, first post-RT response (CR, no CR), Pre-RT SUV of lesion, RT dose (≥45 Gy) and overall response to RT (if CR was achieved). Results: Patient and treatment characteristics are summarized in table 1. 24 (66%) EMPs and 54 (84%) SBPs received a radiation dose ≥45 Gy. After excluding 8 patients who were lost to follow up, 81% of patients with EMPs and 81% with SBPs achieved complete response (CR) with a median time to CR being 11 months (range 0.53–38.9) for EMP and 8 months (range 0.6–89.2) for SBP. All pts achieving a CR were treated with doses ≥40 Gy. Only 1 (3%) EMP and 2 (3%) SBPs had an in-field failure after CR. The 5-year OS was 68% for EMPs and 94% for SBPs [p = 0.007]. Out of 94 pts, 19 died, and cause of death was not related to the plasma cell neoplasm in 7 EMP pts. The 5-year rate of progression to MM was 28% in the EMP group, and 64% in the SBP group [p = 0.006], with progression-free survival (PFS) of 61% In the EMP group and 35% in the SBP group [p = 0.041]. On univariate analysis, sex, age, RT dose (<45 Gy, ≥45 Gy), staging PET, location [EMP vs. SBP] and achieving a CR after RT (at first post-RT response and CR at any time) were analyzed. Pts with EMP were at significantly lower risk for progression to MM (HR 0.3, 95% CI: 0.2, 0.8; p = 0.009) Additionally, Pts with CR on first post-RT imaging were at lower risk for progression to MM (HR 0.6, 95% CI: 0.3, 1.0, p = 0.05). Conclusion: Our data indicates that definitive RT for EMP and SBP can provide excellent LC. Progression to MM remains the main problem and is more common among pts with SBP, which is concordant with previously published literature. Keyword: Multiple Myeloma Conflicts of interests pertinent to the abstract. B. Imber Honoraria: GT Medical Technologies

STOPP/START criteria for potentially inappropriate prescribing in older people: version 3

Key summary pointsAimTo update and validate STOPP/START criteria for potentially inappropriate prescribing.FindingsSTOPP/START version 3 has been expanded and validated by an international European panel of experts in geriatric pharmacotherapy. Version 3, with 190 criteria, is significantly larger than version 2 (114 criteria), reflecting the expansion of the pharmacopeia and clinical trials evidence base relevant to older people since the publication of version 2.MessageSTOPP/START version 3 represents an updated explicit list of potentially inappropriate medications and potential prescribing omissions aimed at optimizing medication and minimizing adverse drug reactions and events during medication review in older people, particularly those with multimorbidity and polypharmacy.

A practical checklist for return of results from genomic research in the European context

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws.

The Role of CRP POC Testing in the Fight against Antibiotic Overuse in European Primary Care: Recommendations from a European Expert Panel.

Tackling antibiotic resistance represents one of the major challenges in modern medicine, and limiting antibiotics' overuse represents the first step in this fight. Most antibiotics are prescribed in primary care settings, and lower respiratory tract infections (LRTIs) are one of the most common indications for their prescription. An expert panel conducted an extensive report on C-reactive protein point-of-care (CRP POC) testing in the evaluation of LRTIs and its usefulness to limit antibiotic prescriptions. The expert panel stated that CRP POC testing is a potentially useful tool to limit antibiotic prescriptions for LRTI in a community setting. CRP POC must be used in conjunction with other strategies such as improved communication skills and the use of other molecular POC testing. Potential barriers to the adoption of CRP POC testing are financial and logistical issues. Moreover, the efficacy in limiting antibiotic prescriptions could be hampered by the fact that, in some countries, patients may gain access to antibiotics even without a prescription. Through the realization of a better reimbursement structure, the inclusion in standardized procedures in local guidelines, and better patient education, CRP point-of-care testing can represent a cornerstone in the fight against antimicrobial resistance.

Management of inflammation in dry eye disease: Recommendations from a European panel of experts.

Early initiation of anti-inflammatory therapies is recommended for dry eye disease (DED) to break the vicious cycle of pathophysiology. However, there is limited guidance on how to implement topical ciclosporin (CsA) and corticosteroid treatment into clinical practice. This expert-led consensus provides practical guidance on the management of DED, including when and how to use topical CsA. A steering committee (SC) of seven European DED experts developed a questionnaire to gain information on the unmet needs and management of DED in clinical practice. Consensus statements on four key areas (disease severity and progression; patient management; efficacy, safety and tolerability of CsA; and patient education) were generated based on the responses. The SC and an expanded expert panel of 22 members used a nine-point scale (1 = strongly disagree; 9 = strongly agree) to rate statements; a consensus was reached if ≥75% of experts scored a statement ≥7. A stepwise approach to DED management is required in patients presenting with moderate corneal staining. Early topical CsA initiation, alone or with corticosteroids, should be considered in patients with clinical risk factors for severe DED. Patient education is required before and during treatment to manage expectations regarding efficacy and tolerability in order to optimise adherence. Follow-up visits are required, ideally at Month 1 and every 3 months thereafter. Topical CsA may be continued indefinitely, especially when surgery is required. This consensus fills some of the knowledge gaps in previous recommendations regarding the use of topical corticosteroids and CsA in patients with DED.

The Importance of Timing, Fundamental Attitudes, and Appropriate Interventions as Key Aspects of Chaplain Suicide Prevention: A European Expert Panel of Mental Health Chaplains.

An expert panel consisting of six mental health chaplains from several European countries was convened to ascertain the specific contribution of mental health chaplains to suicide prevention, and to generate good practices for suicide prevention. Three themes emerged: (1) the importance of timing; (2) fundamental attitudes of the chaplain towards the patient, and (3) appropriate interventions.

Predictors of Response to Radiation Therapy and of Progression to Multiple Myeloma in Patients with Solitary Bone and Extramedullary Plasmacytomas

Purpose/Objective(s): Radiation therapy (RT) plays an important role in treating Solitary Extramedullary (EMP) and Solitary Bone (SBP) Plasmacytomas. The objective of this study is to review the effectiveness of RT in locally controlling the disease and looking at factors that predict progression to Multiple Myeloma (MM) in the PET scan-era. Materials/Methods: We performed a retrospective analysis of consecutive plasmacytoma patients (pts) treated at our high-volume center. We identified 94 pts, of which 62 were diagnosed with SBP and 32 with EMP, without evidence of MM at diagnosis (end-organ damage, >10% bone marrow involvement, >1 plasmacytoma). We identified 94 total pts, largest series to date in the literature, treated with RT (no pts received systemic therapy) between January 1, 2000, through December 31, 2020. Of the 94 pts, 62 were diagnosed with SBP and 32 with EMP, without evidence of MM at diagnosis (end-organ damage, >10% bone marrow involvement, >1 plasmacytoma). We utilized radiographic staging including PET scans and clinical assessments to determine patient outcomes. Outcomes include initial radiographic responses using the European Expert Panel Response Criteria, local control (LC), overall survival (OS), and progression to MM. Kaplan-Meier was used to assess LC and OS. Univariable analysis was done using age, sex, race, plasmacytoma type (EMP vs. SBP), PET scan at staging versus other modalities, first post-RT response (CR, no CR), Pre-RT SUV of lesion, RT dose (≥45Gy) and overall response to RT (if CR was achieved). Results: Patient and treatment characteristics are summarized in table 1. 24 (66%) EMPs and 54 (84%) SBPs received a radiation dose ≥45Gy. After excluding 8 patients who were lost to follow up, 81% of patients with EMPs and 81% with SBPs achieved complete response (CR) with a median time to CR being 11 months (range 0.53-38.9) for EMP and 8 months (range 0.6-89.2) for SBP. All pts achieving a CR were treated with doses ≥40Gy. Only 1 (3%) EMP and 2 (3%) SBPs had an in-field failure after CR. The 5-year OS was 68% for EMPs and 94% for SBPs [p=0.007]. Out of 94 pts, 19 died, and cause of death was not related to the plasma cell neoplasm in 7 EMP pts. The 5-year rate of progression to MM was 28% in the EMP group, and 64% in the SBP group [p=0.006], with progression-free survival (PFS) of 61% In the EMP group and 35% in the SBP group [p=0.041]. On univariate analysis, sex, age, RT dose (<45 Gy, ≥45 Gy), staging PET, location [EMP vs. SBP] and achieving a CR after RT (at first post-RT response and CR at any time) were analyzed. Pts with EMP were at significantly lower risk for progression to MM (HR 0.3, 95% CI 0.2, 0.8; p=0.009) Additionally, Pts with CR on first post-RT imaging were at lower risk for progression to MM (HR 0.6, 95% CI 0.3, 1.0, p=0.05). Conclusion: Our data indicates that definitive RT for EMP and SBP can provide excellent LC. Progression to MM remains the main problem and is more common among pts with SBP, which is concordant with previously published literature. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal