International Group Of Experts Research Articles

Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts.

Intervention for critical aortic stenosis in Hutchinson-Gilford progeria syndrome.

Hutchinson-Gilford Progeria Syndrome (HGPS) is an ultra-rare genetic premature aging disease that is historically fatal in teenage years, secondary to severe accelerated atherosclerosis. The only approved treatment is the farnesyltransferase inhibitor lonafarnib, which improves vascular structure and function, extending average untreated lifespan of 14.5 years by 4.3 years (30%). With this longer lifespan, calcific aortic stenosis (AS) was identified as an emerging critical risk factor for cardiac death in older patients. Intervention to relieve critical AS has the potential for immediate improvement in healthspan and lifespan. However, HGPS patient-device size mismatch, pervasive peripheral arterial disease, skin and bone abnormalities, and lifelong failure to thrive present unique challenges to intervention. An international group of experts in HGPS, pediatric and adult cardiology, cardiac surgery, and pediatric critical care convened to identify strategies for successful treatment. Candidate procedures were evaluated by in-depth examination of 4 cases that typify HGPS clinical pathology. Modified transcatheter aortic valve replacement (TAVR) and left ventricular Apico-Aortic Conduit (AAC) placement were deemed high risk but viable options. Two cases received TAVR and 2 received AAC post-summit. Three were successful and 1 patient died perioperatively due to cardiovascular disease severity, highlighting the importance of intervention timing and comparative risk stratification. These breakthrough interventions for treating critical aortic stenosis in HGPS patients could rewrite the current clinical perspective on disease course by greatly improving late-stage quality of life and increasing lifespan. Expanding worldwide medical and surgical competency for this ultra-rare disease through expert information-sharing could have high impact on treatment success.

Meniscal extrusion consensus statement: Acollaborative survey within the Meniscus International Network (MenIN) Study Group.

The purpose of the present study was to perform a survey administered to members of the Meniscus International Network (MenIN) Study Group, seeking to delineate the most contentious aspects of meniscal extrusion classification and provide a foundation for new, more comprehensive definitions and treatments for these pathologies. MenIN Study Group is a group of international experts treating and performing research on meniscus pathology and treatment. All MenIN Study Group members were asked to complete a survey aimed at establishing criteria for the optimal classification system for meniscal extrusion. Data obtained from the completed questionnaires were transferred into a spreadsheet and then analysed. All responses are presented as counts, percentagesor means. Forty-seven (85.5%) MenIN Study Group members completed the survey and were included in this analysis. Key aspects recommended for inclusion in a comprehensive classification system for meniscal extrusion included laterality (93.6%), anatomical location (76.6%), patient age (76.6%), body mass index (BMI) (68.1%)and aetiology (68.1%). For classifying meniscal extrusion, 53.2% considered the distance in millimetres from the tibial plateau's outer margin as the most reliable measurement technique on imaging. Preferences for imaging modalities varied, with 44.7% favouring weight-bearing magnetic resonance imaging (MRI) and 36.2% opting for weight-bearing ultrasound due to its greater availability. Respondents advocated for a classification system addressing stability or progression of meniscal extrusion (66%), reducibility (53.2%), potential progression of knee osteoarthritis (OA) (83%), influencing treatment approaches (83%), a gradation system (83%), consideration of dynamic factors (66%), association with clinical outcomes and prognosis (76.6%)and investigation around centralization procedures (57.4%). In conclusion, the findings of this survey shed light on the global perspectives regarding meniscal extrusion classification. It was generally felt that a new classification of extrusion measured on MRI scans at the mid-tibial plateau should be developed, which considers factors such as laterality, anatomical location, age, BMIand aetiology. Additionally, the results support the integration of dynamic factors and clinical outcomes in MRI-based classifications to inform treatment approaches. Level IV.

A Systematic Guideline by the ASPN Workgroup on the Evidence, Education, and Treatment Algorithm for Painful Diabetic Neuropathy: SWEET.

Painful diabetic neuropathy (PDN) is a leading cause of pain and disability globally with a lack of consensus on the appropriate treatment of those suffering from this condition. Recent advancements in both pharmacotherapy and interventional approaches have broadened the treatment options for PDN. There exists a need for a comprehensive guideline for the safe and effective treatment of patients suffering from PDN. The SWEET Guideline was developed to provide clinicians with the most comprehensive guideline for the safe and appropriate treatment of patients suffering from PDN. The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations for PDN. A multidisciplinary group of international experts developed the SWEET guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Meeting Abstracts, and Scopus to identify and compile the evidence for diabetic neuropathy pain treatments (per section as listed in the manuscript) for the treatment of pain. Manuscripts from 2000-present were included in the search process. After a comprehensive review and analysis of the available evidence, the ASPN SWEET guideline was able to rate the literature and provide therapy grades for most available treatments for PDN utilizing the United States Preventive Services Task Force criteria. The ASPN SWEET Guideline represents the most comprehensive review of the available treatments for PDN and their appropriate and safe utilization.

THE FOOD CRISIS AND THE THREAT OF HUNGER ON EARTH

This article examines such a global problem as the food crisis and the threat of hunger on the planet. An analysis of the causes and composition of the global food problem is carried out. Attention is paid to the statistics and dynamics of changes in the problem of hungry people around the globe and the entire current situation at the moment. Recommendations and attempts to resolve the food crisis by international groups of experts, including scientists and politicians, are also considered in order to implement the proposals made on this issue and overcome the current problem

Endoscopic Surveillance of the Intestinal Allograft: Recommendations From the Intestinal Rehabilitation and Transplant Association Working Group.

Intestinal transplant (ITx) rejection lacks a reliable noninvasive biomarker and rejection surveillance relies on serial endoscopies and mucosal biopsies followed by histologic assessment. Endoscopic biopsies are also essential for identifying other ITx-related complications such as infectious, allergic, and inflammatory graft enteritis as well as post-transplant lymphoproliferative disease or graft versus host disease. In spite of its central role in ITx, published guidelines on endoscopy and biopsy are lacking and significant variability between centers in terms of timing and technical performance exists. Therefore, an international expert group convened and discussed several aspects related to the surveillance endoscopy after ITx with the aim to summarize and standardize its practice. This article summarizes these considerations on endoscopic ITx monitoring and highlights practices of surveillance and for-cause endoscopy, biopsy techniques, pathologic evaluation, potential risks and complications, outsourcing, and less-invasive monitoring techniques.

Abstract A034: A new international program to accelerate novel therapeutics for brain tumors: presenting the brain tumor research novel therapeutics accelerator

Abstract Each year, we see many journal manuscripts highlighting successful pre-clinical experiments for potential new brain tumor therapies. Only a few of these therapies move forward into successful clinical trials. Indeed, developing a comprehensive translational program covers many aspects, including but not limited to, medicinal chemistry, blood brain barrier penetration, tumor heterogeneity, delivery, commercialization, and navigating the regulatory environment. Because of this, bringing a successful translational project from bench to bedside requires access to a diverse set of cutting-edge expertise to give promising therapies the best chance of succeeding. Recognizing that this journey is not easy to navigate, the Tessa Jowell Brain Cancer Mission has launched an international Brain Tumor Research Novel Therapeutics Accelerator (BTR-NTA). This program is led by an international group of drug development and brain tumor experts who provide independent guidance to researchers to position their therapeutic along a realistic pathway to clinical trials. The BTR-NTA is open to any international academic and industry researchers developing a medicinal product, delivery technology or device for brain tumors. The BTR-NTA welcomes groups at any stage of pre-clinical or clinical work. Academics and smaller biotech’s could benefit from feedback on their pre-clinical studies and plans for commercialization, while larger pharmaceutical companies could benefit from access to brain tumor specific expertise and patient input into clinical trial design. Researchers can apply to BTR-NTA twice a year, and if accepted will go through the following process: 1. Complete an application form covering work to date and future plans under strict confidentiality agreements; 2. Attend an in-person meeting with a tailored group of experts to further discuss their work; and 3. Receive a comprehensive written report from the BTR-NTA committee with feedback on strengths and weaknesses and guidance on next steps. The expert committee dedicates half a day to reviewing the applicants’ work in-person, and extensive time pre- and post-meeting. Throughout the process, applicants receive up to 150 hours of expert input. The multidisciplinary nature of the review committee spans the entirety of the drug development pathway to support longitudinal collaboration and avoid a siloed approach to research. The BTR-NTA was designed after a similar program in another rare disease field yielded impressive results. Thanks to charitable funding, the BTR-NTA is free to academics and at low cost for industry. The BTR-NTA aims to help address barriers for researchers by highlighting potential pitfalls or risks, providing multi-disciplinary feedback on work to date, giving constructive guidance on next steps and strengthening international collaboration in the brain tumor field. The ultimate goal of the BTR-NTA is to enable researchers with therapy for brain tumors to navigate the drug development journey and make it to the clinic in a low-cost and timely way. Citation Format: Nicky Huskens, Charlotte Aitken, Katie Bushby. A new international program to accelerate novel therapeutics for brain tumors: presenting the brain tumor research novel therapeutics accelerator [abstract]. In: Proceedings of the AACR Special Conference on Brain Cancer; 2023 Oct 19-22; Minneapolis, Minnesota. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_1):Abstract nr A034.

Results from a cross-specialty consensus on optimal management of patients with chronic kidney disease (CKD): from screening to complications

BackgroundChronic kidney disease (CKD) affects around 10% of the global population and has been estimated to affect around 50% of individuals with type 2 diabetes and 50% of those with...

77 Emerging strategies for head & neck cancer prevention

Head and neck squamous cell carcinoma (HNSCC) is a group of malignancies mostly involving the oral cavity, oropharynx, hypopharynx, and larynx. All together they represent the seventh most common cancer diagnosis worldwide. With 890,000 new cases and 450,000 deaths annually per GLOBOCAN estimates, HNSCC accounts for roughly 4.5% of cancer diagnoses and deaths. In the developing world, the incidence of HNSCC is growing with increasing consumption of tobacco (smoked or chewed), alcohol, and areca nut (betel quid). Alcohol and tobacco have a synergistic effect, with the heavy consumption of both increasing HNSCC risk 40-fold. In this context, the risk of second primary tumors in the field of cancerization is high. In developed nations, HPV-related HNSCC surpasses tobacco- and alcohol-related disease. HPV-related HNSCC more commonly affects the oropharynx, hypopharynx, and larynx than the oral cavity, and is associated with a significantly longer survival.Based on this epidemiological facts, different strategies involving primary, secondary and tertiary prevention will be discussed. For prevention of HPV-positive HNSCC, emphasis will be given to vaccination strategies and novel diagnostic biomarkers for early detection. HPV-negative HNSCC are mostly represented by oral cavity cancers. In this particular context, a Working Group of international experts was convened by the International Agency for Research on Cancer (IARC) to review and assess all available evidence on the effectiveness of primary and secondary preventive interventions in reducing the incidence of and mortality from oral cancer. Available evidence will be summarized. Finally, we will address the challenge of unmet oral cancer prevention in the context of oral potentially malignant disorders (OPMD) in terms of oral cancer risk assessment and pharmacological interception approachs.In conclusion, a lot remains to be done to improve the prevention of HNSCC but significant opportunities exist that will hopefully allow in the near future to significantly decrease its morbidity, mortality, and profound impact on patient's quality of life.

Revised ISHAM-ABPA working group clinical practice guidelines for diagnosing, classifying and treating allergic bronchopulmonary aspergillosis/mycoses.

The International Society for Human and Animal Mycology (ISHAM) working group proposed recommendations for managing allergic bronchopulmonary aspergillosis (ABPA) a decade ago. There is a need to update these recommendations due to advances in diagnostics and therapeutics. An international expert group was convened to develop guidelines for managing ABPA (caused by Aspergillus spp.) and allergic bronchopulmonary mycosis (ABPM; caused by fungi other than Aspergillus spp.) in adults and children using a modified Delphi method (two online rounds and one in-person meeting). We defined consensus as ≥70% agreement or disagreement. The terms "recommend" and "suggest" are used when the consensus was ≥70% and <70%, respectively. We recommend screening for A. fumigatus sensitisation using fungus-specific IgE in all newly diagnosed asthmatic adults at tertiary care but only difficult-to-treat asthmatic children. We recommend diagnosing ABPA in those with predisposing conditions or compatible clinico-radiological presentation, with a mandatory demonstration of fungal sensitisation and serum total IgE ≥500 IU·mL-1 and two of the following: fungal-specific IgG, peripheral blood eosinophilia or suggestive imaging. ABPM is considered in those with an ABPA-like presentation but normal A. fumigatus-IgE. Additionally, diagnosing ABPM requires repeated growth of the causative fungus from sputum. We do not routinely recommend treating asymptomatic ABPA patients. We recommend oral prednisolone or itraconazole monotherapy for treating acute ABPA (newly diagnosed or exacerbation), with prednisolone and itraconazole combination only for treating recurrent ABPA exacerbations. We have devised an objective multidimensional criterion to assess treatment response. We have framed consensus guidelines for diagnosing, classifying and treating ABPA/M for patient care and research.

Pharmacokinetic Research in Pediatric Extracorporeal Therapies: Current State and Future Directions

Extracorporeal life support (ECLS), including extracorporeal membrane oxygenation (ECMO) and continuous renal replacement therapy (CRRT), is a lifesaving therapy for critically ill children. Despite this, these modalities carry frustratingly high mortality rates. One driver of mortality may be altered drug disposition due to a combination of underlying illness, patient-circuit interactions, and drug-circuit interactions. Children receiving ECMO and/or CRRT routinely receive 20 or more drugs, and data supporting optimal dosing are lacking for most of these medications. The Pediatric Paracorporeal and Extracorporeal Therapies Summit (PPETS) gathered an international group of experts in the fields of ECMO, CRRT, and other ECLS modalities to discuss the current state of these therapies, disseminate innovative support strategies, share clinical experiences, and foster future collaborations. Here, we summarize the conclusions of PPETS and put forward a pathway to optimize pharmacokinetic (PK) research in this population. We must prioritize specific medications for in-depth study to improve drug use in ECLS and patient outcomes. Based on frequency of use, potential for adverse outcomes if dosed inappropriately, and lack of existing PK data, a list of high-priority drugs was compiled for future research. Researchers must additionally reconsider study designs, emphasizing pooling of resources through multicenter studies and the use of innovative PK modeling techniques. Finally, the integration of validated PK models into clinical practice must be streamlined to deliver optimal medication use at the bedside. Focusing on the proposed list of highlighted medications and key methodological considerations will maximize the impact of future research.

International recommendations for screening and preventative practices for long-term survivors of transplantation and cellular therapy: a 2023 update.

As hematopoietic cell transplantation (HCT) and cellular therapy expand to new indications and international access improves, the volume of HCT performed annually continues to rise. Parallel improvements in HCT techniques and supportive care entails more patients surviving long-term, creating further emphasis on survivorship needs. Survivors are at risk for developing late complications secondary to pre-, peri- and post-transplant exposures and other underlying risk-factors. Guidelines for screening and preventive practices for HCT survivors were originally published in 2006 and updated in 2012. To review contemporary literature and update the recommendations while considering the changing practice of HCT and cellular therapy, an international group of experts was again convened. This review provides updated pediatric and adult survivorship guidelines for HCT and cellular therapy. The contributory role of chronic graft-versus-host disease (cGVHD) to the development of late effects is discussed but cGVHD management is not covered in detail. These guidelines emphasize special needs of patients with distinct underlying HCT indications or comorbidities (e.g., hemoglobinopathies, older adults) but do not replace more detailed group, disease, or condition specific guidelines. Although these recommendations should be applicable to the vast majority of HCT recipients, resource constraints may limit their implementation in some settings.

A122 INTEROBSERVER AGREEMENT FOR THE PARIS CLASSIFICATION OF COLORECTAL POLYPS AMONGST SURGEONS, GASTROENTEROLOGISTS, TRAINEES AND EXPERTS: A VIDEO-BASED STUDY

Abstract Background Colonic polyps are described based on their macroscopic shape, according to the Paris classification. This represents a useful tool to communicate polyp morphology between endoscopists, however, the agreement between endoscopists on polyp morphology evaluation has not been demonstrated in the literature. We were interested in evaluating endoscopist agreement using the Paris classification. Aims The aim of this study was to evaluate endoscopist agreement using the Paris classification. Methods We conducted a prospective video-based study evaluating endoscopist assessment of polyp morphology. An international group of endoscopists including surgeons, gastroenterologists, experts and trainees were included. Primary outcome was overall inter-observer agreement for the Paris classification. Secondary outcomes were inter-observer agreement stratified by endoscopist characteristics. Results 11 endoscopists were included in the analysis with 1320 morphologic assessments of 120 individual polyps. There was low overall inter-observer agreement for the Paris classification with an overall Light’s Kappa of 0.19. Agreement remained low for men (Κ=0.25), women (Κ=0.25), gastroenterologists (K=0.23), surgeons (K=0.11), trainees (K=0.33), and experts (K=0.29). Endoscopists who have received training on lesion evaluation in Asia had higher inter-observer agreement when using the Paris classification compared to endoscopists in the west (K= 0.50 vs 0.26). Conclusions Agreement when using the Paris classification was low amongst a varied international group of surgeons, gastroenterologists, trainees and experts. Training in the east where higher emphasis is placed on lesion characterization was associated with the highest inter-observer agreement. Funding Agencies None

International expert meeting on the donation and use of human milk: Brief report.

Where a mother's own milk is not available or is insufficient, donor human milk (DHM) processed by a human milk bank (HMB) is the recommended next best alternative. HMBs exist in over 65 countries. However, most countries have yet to establish national policies or programmes that support the provision of DHM. In July 2019, a group of international experts in fields relevant to human milk banking gathered at a meeting organised by the Institute of Biomedical Ethics, University of Zurich, and co-sponsored by the World Health Organisation. Prompted by the growing interest globally in creating and sustaining HMBs and addressing current safety and ethical concerns and standards, the aims of the meeting were to define knowledge gaps, determine the need for and scope of global guidelinesand provide recommendations on steps that need to be taken at the international level. Following wide-ranging discussions that included the integration of milk banks into health care systems, strategy and policy, quality and safety, the use of DHM and associated ethical considerations, the overall conclusion of the meeting was that in the absence of global recommendations on the implementation, operation and regulation of HMBs, evidence-based guidance is urgently needed.

Biofield therapies: Guidelines for reporting clinical trials

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

European Society of Cardiology Quality indicators for the care and outcomes of adults undergoing transcatheter aortic valve implantation.

To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI). We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs. We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry. We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives.

Defining ablative radiotherapy in patients with hepatocellular carcinoma: An expert consensus.

485 Background: External beam radiotherapy (EBRT) is a highly effective treatment in select patients with hepatocellular carcinoma (HCC). However, there are many types of EBRT described in the literature with no formal definition of what constitutes “ablative.” Thus, we convened a group of international experts to provide consensus on the parameters that define ablative EBRT in HCC. Methods: A Steering Committee was convened to generate a series of Key Criteria (KC) that could be used to define ablative EBRT for HCC. KC were based on factors related to dose, fractionation, radiobiology, target identification, and delivery technique. An international panel of experts participated in a modified Delphi (mDelphi) process to independently answer questions for each KC. Respondents were given 30 days to respond in round 1 of the mDelphi and 14 days to respond in round 2. A threshold of ≥ 70% was used to define consensus for answers to each KC. Results: Invitations were sent to 40 individuals and 35 (88%) returned responses. In the first round of the mDelphi, 3 of 7 KC reached consensus. In the second round, 100% of participants returned responses and consensus was reached in 3 of the remaining 4 KC. Based on this mDelphi analysis, there was expert agreement that ablative EBRT for HCC should be defined as 1) a BED10 ≥ 80 Gy, 2) daily imaging and multi-phasic contrast used for target delineation should be used, 3) treatment breaks (e.g., for adaptive EBRT) are allowed, but the total treatment time should be ≤ 6 weeks, 4) the equivalent dose when treating with protons should use a conversion factor of 1.1, and 5) there is no single conversion factor for carbon ions. In one KC, which questioned the expert’s opinion on the α/β ratio of HCC, consensus was not achieved. Conclusions: Using an mDelphi method assessing expert opinion, we provide the first consensus definition of ablative EBRT for HCC. Empiric data are required to define the α/β of HCC.

Defining Minimum Treatment Parameters of Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma: An Expert Consensus

External beam radiation therapy (EBRT) is a highly effective treatment in select patients with hepatocellular carcinoma (HCC). However, the Barcelona Clinic Liver Cancer system does not recommend the use of EBRT in HCC due to a lack of sufficient evidence and intends to perform an individual patient level meta-analysis of ablative EBRT in this population. However, there are many types of EBRT described in the literature with no formal definition of what constitutes "ablative." Thus, we convened a group of international experts to provide consensus on the parameters that define ablative EBRT in HCC. Fundamental parameters related to dose, fractionation, radiobiology, target identification, and delivery technique were identified by a steering committee to generate 7 Key Criteria (KC) that would define ablative EBRT for HCC. Using a modified Delphi (mDelphi) method, experts in the use of EBRT in the treatment of HCC were surveyed. Respondents were given 30 days to respond in round 1 of the mDelphi and 14 days to respond in round 2. A threshold of ≥70% was used to define consensus for answers to each KC. Of 40 invitations extended, 35 (88%) returned responses. In the first round, 3 of 7 KC reached consensus. In the second round, 100% returned responses and consensus was reached in 3 of the remaining 4 KC. The distribution of answers for one KC, which queried the a/b ratio of HCC, was such that consensus was not achieved. Based on this analysis, ablative EBRT for HCC was defined as a BED10 ≥80 Gy with daily imaging and multiphasic contrast used for target delineation. Treatment breaks (eg, for adaptive EBRT) are allowed, but the total treatment time should be ≤6 weeks. Equivalent dose when treating with protons should use a conversion factor of 1.1, but there is no single conversion factor for carbon ions. Using a mDelphi method assessing expert opinion, we provide the first consensus definition of ablative EBRT for HCC. Empirical data are required to define the a/b of HCC.

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency.

Clinical research professionals play a critical role in the design, conduct, and oversight of clinical trials, and they must have the knowledge, skills, and abilities to ensure that trials are conducted ethically, safely, and in accordance with regulatory requirements. As clinical research has evolved from being a necessary activity for the development and regulatory approval of new medicines to an accredited academic discipline and, more recently, to a globally recognized profession, the methods of education and training of professionals have also evolved. Initially, on-the-job informal coaching and specialized training organizations led to formalized and accredited academic degree programs and, more recently, to international competency standards and competency maintenance through continuous professional development. The Joint Task Force (JTF) for Clinical Trial Competency is a multidisciplinary, international group of experts who came together to aggregate and refine competency standards for clinical research professionals, first published in 2014. The 8 domains and 49 specific core competencies of the JTF Framework have become a globally recognized standard upon which education and training programs, role descriptions, and upward mobility criteria for professionals are now based. The JTF meets regularly and, through its workgroups, continues to evolve in response to the changing needs of the profession. The JTF is committed to continuous improvement to ensure that clinical research professionals have the competence necessary to conduct safe, ethical, and high-quality clinical research.

Defining childhood disability: ICF-CY developmental code sets

Purpose This study describes the development of four age-based item code sets from WHO’s International classification of functioning disability and health, children and youth version (ICF-CY). Given the continuing goal of universal implementation of the ICF-CY, a reduced set of codes was identified from more than 1600 codes to facilitate the use of the classification for clinical, research and policy applications of the ICF-CY Methods The ICF-CY developmental code sets were developed by consensus using the Delphi method. A multi-disciplinary group of international experts representing 27 countries from 5 WHO world regions completed a series of iterative online surveys to rate categories of child functioning essential for inclusion in the respective age-based code set. Results Four age-based code sets covering 37, 52, 60 and 57 codes across four domains of the ICF-CY were successfully derived with a high level of participant consensus. The code sets align with developmental theory and represent essential indicators of functioning defining key stages of child development. Conclusion The ICF-CY developmental code sets offer a common, universal language of childhood functioning and disability with global application for multidisciplinary research, clinical practice and policy.