Статті в журналах: "Standardized consortium"

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Naidu, Priyanka, Alexander T. Plonkowski, Caroline A. Yao, and William P. Magee. "Evolution of Cleft Lip and Palate Surgery and the Pursuit for Consensus on Standardized Algorithms of Care." Plastic and Reconstructive Surgery - Global Open 13, no. 3 (March 2025): e6643. https://doi.org/10.1097/gox.0000000000006643.

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Summary: Cleft lip and palate (CLP) surgery has evolved over centuries in an attempt to achieve anatomical closure while optimizing speech and limiting fistulas and midface hypoplasia. Masters of cleft surgery and early pioneers inspired generations of surgical innovators to refine techniques and timing to improve surgical outcomes. Constant modification has resulted in significant diversity of cleft surgical protocols across institutions. Unlike many other surgical conditions, there is no gold-standard algorithm of care for CLP. Several international consortiums, including Eurocleft, Americleft, and Scandcleft, aimed to investigate the ideal cleft care protocol. Despite the inclusion of multiple institutions and attempts at long-term follow-up, these studies were limited by small sample sizes, lack of diversity in patient population, poor long-term follow-up, lack of standardized measurement tools, and inability to control for confounders such as severity. This article aimed to present the findings of these early pioneer consortiums in their pursuit for the optimal CLP surgical protocol and recommend a direction for future research with a global consortium of experts in cleft care.

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Hernandez-Hernandez, Oswaldo. "In vitro Gastrointestinal Models for Prebiotic Carbohydrates: A Critical Review." Current Pharmaceutical Design 25, no. 32 (November 15, 2019): 3478–83. http://dx.doi.org/10.2174/1381612825666191011094724.

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Background: In the last decade, various consortia and companies have created standardized digestion protocols and gastrointestinal simulators, such as the protocol proposed by the INFOGEST Consortium, the simulator SHIME, the simulator simgi®, the TIM, etc. Most of them claim to simulate the entire human gastrointestinal tract. However, few results have been reported on the use of these systems with potential prebiotic carbohydrates. Methods: This critical review addresses the existing data on the analysis of prebiotic carbohydrates by different in vitro gastrointestinal simulators, the lack of parameters that could affect the results, and recommendations for their enhancement. Results: According to the reviewed data, there is a lack of a realistic approximation of the small intestinal conditions, mainly because of the absence of hydrolytic conditions, such as the presence of small intestinal brush border carbohydrases that can affect the digestibility of different carbohydrates, including prebiotics. Conclusion: There is a necessity to standardize and enhance the small intestine simulators to study the in vitro digestibility of carbohydrates.

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Heilbronner, U. "The International Consortium of Lithium Genetics (ConLiGen): Achievements and Collaborations." V.M. BEKHTEREV REVIEW OF PSYCHIATRY AND MEDICAL PSYCHOLOGY, no. 4-1 (December 9, 2019): 51–52. http://dx.doi.org/10.31363/2313-7053-2019-4-1-51-52.

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Lithium is an indispensable tool of modern psychiatry. Although it is well-known that response to lithium is a familial trait, available research on pharmacogenetics regarding lithium treatment has, in the past, produced few reproducible results. The Consortium of Lithium Genetics (ConLiGen) was initiated by Thomas G. Schulze and Francis J. McMahon in 2008 to overcome these limitations. To date, researchers from 39 countries have joined the consortium, making it a truly international effort. A hallmark of the consortium is the use of an 11-point lithium response rating scale defined by Martin Alda and colleagues. The pooling of genotype data from over 2,500 patients phenotyped with this standardized response scale, have led to initial successes, which form the basis for further research.

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Ramsey, Keenan A., Carel G. M. Meskers, Marijke C. Trappenburg, Maria Giulia Bacalini, Massimo Delledonne, Paolo Garagnani, Carolyn Greig, et al. "The Physical Activity and Nutritional INfluences in Ageing (PANINI) Toolkit: A Standardized Approach towards Physical Activity and Nutritional Assessment of Older Adults." Healthcare 10, no. 6 (May 31, 2022): 1017. http://dx.doi.org/10.3390/healthcare10061017.

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Assessing multiple domains of health in older adults requires multidimensional and large datasets. Consensus on definitions, measurement protocols and outcome measures is a prerequisite. The Physical Activity and Nutritional INfluences In Ageing (PANINI) Toolkit aims to provide a standardized toolkit of best-practice measures for assessing health domains of older adults with an emphasis on nutrition and physical activity. The toolkit was drafted by consensus of multidisciplinary and pan-European experts on ageing to standardize research initiatives in diverse populations within the PANINI consortium. Domains within the PANINI Toolkit include socio-demographics, general health, nutrition, physical activity and physical performance and psychological and cognitive health. Implementation across various countries, settings and ageing populations has proven the feasibility of its use in research. This multidimensional and standardized approach supports interoperability and re-use of data, which is needed to optimize the coordination of research efforts, increase generalizability of findings and ultimately address the challenges of ageing.

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Morton, Colin, Gillian X. M. Chin, Jacob Carse, Stephen McKenna, Rubeta Matin, and Colin Fleming. "Teledermatology & Digital Dermatology SymposiumOral presentationsBT01 Developing a national artificial intelligence-assisted skin cancer pathway." British Journal of Dermatology 191, Supplement_1 (June 28, 2024): i189. http://dx.doi.org/10.1093/bjd/ljae090.399.

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Abstract The AI Skin Cancer Consortium seeks to progress integration of artificial intelligence (AI) into the skin cancer referral pathway to promote rapid diagnosis of skin cancer and reassurance with benign lesions. In contrast to other fields of medicine, such as radiology, dermatology has lacked standardization in data acquisition, which is required for high-quality, reproducible and interoperable AI algorithm performance. Beginning in 2021, the consortium has made substantial progress towards defining a national pathway, technology architecture and data flows. We describe a standardized approach to acquisition of macroscopic and dermoscopic images, and technical and clinical metadata in a DICOM (Digital Imaging and Communications in Medicine) format, currently acquired in outpatient imaging centres and in general practice. In order to develop a transparent competitive environment for testing of this standardized National Health Service (NHS) pipeline, the consortium created a Small Business Research Initiative funded via a government agency. Three companies were awarded funding for this two-phase programme, from 15 applicants. These industry partners tested the pipeline within a trusted research environment (TRE), using real-world data. All industry partners were able to evaluate skin lesion images in combination with interoperable clinical metadata and run existing algorithms in the TRE. We report progress on this competition and also on the process of creating a national database, to permit competitive testing performance of different algorithms with specific clinical use cases. To assess the cost-effectiveness of introducing AI into the skin cancer pathway, we have also collaborated with the York Health Economics Consortium to produce a model to permit estimation of the impact of an AI triage tool to assist clinician triage. The recent vision statement from the British Association of Dermatologists encourages AI solutions intended to address a clinical unmet need and that integrates into patient pathways to enhance the service provided by healthcare professionals [https://www.bad.org.uk/clinical-services/artificial-intelligence/vision-statement-on-artificial-intelligence-ai-interventions/ (last accessed 19 March 2024)]. If the UK is to be at the forefront of skin AI, then it is imperative that the market is stimulated through use of meticulously standardized interoperable data standards with platforms that allow for transparent testing of multiple algorithms. We have successfully introduced a pipeline for safely generating standardized, high-quality images that are suitable for AI, identifying where we can achieve the greatest potential value for introducing AI into the NHS skin cancer referral pathway.

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Alagiakrishnan, Kannayiram, Nancy Zhao, Laurie Mereu, Peter Senior, and Ambikaipakan Senthilselvan. "Montreal Cognitive Assessment Is Superior to Standardized Mini-Mental Status Exam in Detecting Mild Cognitive Impairment in the Middle-Aged and Elderly Patients with Type 2 Diabetes Mellitus." BioMed Research International 2013 (2013): 1–5. http://dx.doi.org/10.1155/2013/186106.

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Aim. This study compares the usefulness of Montreal Cognitive Assessment (MoCA) to Standardized Mini-Mental Status Exam (SMMSE) for diagnosing mild cognitive impairment (MCI) in Type 2 diabetes mellitus (DM) population.Methods. This prospective pilot study enrolled 30 community dwelling adults with Type 2 DM aged 50 years and above. Subjects were assessed using both the SMMSE and MoCA for MCI. In all subjects, depression and dementia were ruled out using the DSM IV criteria, and a functional assessment was done. MCI was diagnosed using the standard test, the European consortium criteria. Sensitivity and specificity analysis, positive and negative predictive values, likelihood ratios and Kappa statistic were calculated.Results. In comparison to consortium criteria, the sensitivity and specificity of MoCA were 67% and 93% in identifying individuals with MCI, and SMMSE were 13% and 93%, respectively. The positive and negative predictive values for MoCA were 84% and 56%, and for SMMSE were 66% and 51%, respectively. Kappa statistics showed moderate agreement between MoCA and consortium criteria (kappa = 0.4) and a low agreement between SMMSE and consortium criteria (kappa = 0.07).Conclusion. In this pilot study, MoCA appears to be a better screening tool than SMMSE for MCI in the diabetic population.

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Hammer, Jeffrey S., James J. Strain, and John Petraitis. "Consortium-Based Consultation/Liaison Research: Commentary and Perspective." International Journal of Psychiatry in Medicine 17, no. 3 (September 1988): 237–48. http://dx.doi.org/10.2190/7rj2-c7q9-wmb7-h9vd.

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Although a consortium approach for clinical trials is a common research strategy which has made important contributions in other disciplines in medicine, to date it has not been employed for research efforts in the consultation/liaison setting. There are several reasons for this: the relative newness of the field, lack of administrative control over patient care, and the unavailability of a standard methodology that could be adapted to multiple sites. Four basic research strategies can be employed within the framework of a research consortium to advance scientific knowledge in consultation/liaison psychiatry: 1) prevalence studies of psychiatric morbidity in medical settings; 2) interrelationship among psychiatric and medical conditions; 3) the outcome of psychiatric interventions within medical milieu; and, 4) cost-benefit evaluation. A field-tested computerized database protocol and a software system useable on an office-based microcomputer were employed to obtain standardized data across multiple training sites. The advantages and disadvantages of consortium studies are described.

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Traboulsee, Anthony, Laurent Létourneau-Guillon, Mark Steven Freedman, Paul W. O’Connor, Aditya Bharatha, Santanu Chakraborty, J. Marc Girard, et al. "Canadian Expert Panel Recommendations for MRI Use in MS Diagnosis and Monitoring." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 42, no. 3 (April 21, 2015): 159–67. http://dx.doi.org/10.1017/cjn.2015.24.

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AbstractBackground: A definitive diagnosis of multiple sclerosis (MS), as distinct from a clinically isolated syndrome, requires one of two conditions: a second clinical attack or particular magnetic resonance imaging (MRI) findings as defined by the McDonald criteria. MRI is also important after a diagnosis is made as a means of monitoring subclinical disease activity. While a standardized protocol for diagnostic and follow-up MRI has been developed by the Consortium of Multiple Sclerosis Centres, acceptance and implementation in Canada have been suboptimal. Methods: To improve diagnosis, monitoring, and management of a clinically isolated syndrome and MS, a Canadian expert panel created consensus recommendations about the appropriate application of the 2010 McDonald criteria in routine practice, strategies to improve adherence to the standardized Consortium of Multiple Sclerosis Centres MRI protocol, and methods for ensuring effective communication among health care practitioners, in particular referring physicians, neurologists, and radiologists. Results: This article presents eight consensus statements developed by the expert panel, along with the rationale underlying the recommendations and commentaries on how to prioritize resource use within the Canadian healthcare system. Conclusions: The expert panel calls on neurologists and radiologists in Canada to incorporate the McDonald criteria, the Consortium of Multiple Sclerosis Centres MRI protocol, and other guidance given in this consensus presentation into their practices. By improving communication and general awareness of best practices for MRI use in MS diagnosis and monitoring, we can improve patient care across Canada by providing timely diagnosis, informed management decisions, and better continuity of care.

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Ybarra, Luiz F., Stéphane Rinfret, Emmanouil S. Brilakis, Dimitri Karmpaliotis, Lorenzo Azzalini, J. Aaron Grantham, David E. Kandzari, et al. "Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations." Circulation 143, no. 5 (February 2, 2021): 479–500. http://dx.doi.org/10.1161/circulationaha.120.046754.

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Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent consistency and uniform interpretability of reported results in CTO intervention. To standardize the field, we therefore assembled a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools, and techniques for CTO interventions. This article summarizes the effort and is organized into 3 sections: key elements and procedural definitions, end point definitions, and clinical trial design principles. The Chronic Total Occlusion Academic Research Consortium is a first step toward improved comparability and interpretability of study results, supplying an increasingly growing body of CTO percutaneous coronary intervention evidence.

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Homer, Jack A., Phillip L. Coule, and Richard B. Schwartz. "National Disaster Life Support Programs—A Model for Standardized, All-Hazards Disaster Medicine Training." Prehospital and Disaster Medicine 24, S1 (April 2009): s119. http://dx.doi.org/10.1017/s1049023x00056028.

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Introduction: The development of the [US] National Disaster Life Support (NDLS) programs (Advanced, Basic, and Core Disaster Life Support) began prior to 11 September 2001, but in its aftermath, the NDLS programs have become a leading all-hazards disaster medicine training program in the US. The NDLS programs are taught through a training center model. The curriculum is revised via the National Disaster Life Support Education Consortium (NDLSEC), a multi-disciplinary, multi-specialty consortium. Methods: The National Disaster Life Support Foundation (NDLSF) is a not-for-profit organization developed by the academic medical centers and partners that developed the NDLS programs. The founding institutions are the Medical College of Georgia, die University of Georgia, the University of Texas Southwestern, the University of Texas-Houston, and the American Medical Association. The NDLSF has die responsibility to oversee, certify, and monitor a network of training centers. The NDLSEC consist of individual members and 75 representative stakeholder organizations. Results: The training center network overseen by the NDLSF consists of 70 training centers in the US and 10 developing international training centers. The NDLSEC has >150 members with representatives from virtually every medical discipline and specialty. More than 70,000 individuals have been trained. Conclusions: The NDLS programs have employed a training center network model to deploy standardized, all-hazards disaster educational programs. The NDLS programs have been successful in bridging die gap in disaster medicine education programs in the US and may represent a useful model for other countries to provide disaster medicine education.

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Breland, Ivey, Ernest Kaninjing, and Damian Francis. "Abstract 6188: Evaluating impact and progress in the iCCaRE consortium for Black men’s approach to reducing prostate cancer disparities." Cancer Research 85, no. 8_Supplement_1 (April 21, 2025): 6188. https://doi.org/10.1158/1538-7445.am2025-6188.

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Abstract The purpose of the Inclusive Cancer Care Research Equity for Black men (iCCaRE) Consortium is to address prostate cancer disparities impacting Black men through collaborative research, education, and advocacy. This study evaluates the progress of iCCaRE in achieving its core objectives across five pilot projects supported by multi-institutional partners. Specifically, iCCaRE aims to expand research infrastructure, develop culturally tailored interventions using artificial intelligence to address social determinants of health, explore modifiable social-biological factors affecting patient outcomes, and provide extensive research training for underrepresented minority scientists and advocates. Our methodology involved the creation and implementation of a comprehensive data collection tool via Qualtrics to assess activity outcomes across the Consortium. This tool enabled standardized reporting on publications, grants awarded, media reach, community impact, and additional metrics tied to scientific productivity and partnership engagement. Unpublished data collected this year indicate substantial progress, including an increase in collaborative research outputs, expanded access to prostate cancer care resources, and enhanced engagement with both clinical and community-based partners. These findings underscore the Consortium’s effectiveness in fostering scientific collaboration, developing targeted interventions, and creating infrastructure to support sustainable improvements in prostate cancer outcomes for Black men. These accomplishments provide a strong foundation for iCCaRE’s transition into Phase 2, with plans to deepen community engagement, expand research training, and enhance data-driven insights through advanced analytics. Citation Format: Ivey Breland, Ernest Kaninjing, Damian Francis. Evaluating impact and progress in the iCCaRE consortium for Black men’s approach to reducing prostate cancer disparities [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 6188.

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Honig, Gerard. "TOWARDS A COMMON VALIDATED METHODOLOGY FOR HISTOLOGIC MEASUREMENT OF MUCOSAL HEALING IN ULCERATIVE COLITIS: INTRODUCING A NEW PROJECT OF THE BIOMARKERS CONSORTIUM OF THE FOUNDATION FOR THE NIH." Inflammatory Bowel Diseases 28, Supplement_1 (January 22, 2022): S35. http://dx.doi.org/10.1093/ibd/izac015.052.

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Abstract Ulcerative colitis is a chronic, debilitating disease characterized by damage to the mucous membrane (mucosa) lining the lower gastrointestinal tract. Endoscopic and histological evidence of healing of the damaged mucosa, referred to as mucosal healing, is increasingly accepted as an important endpoint in clinical practice and in clinical trials due to its association with improved clinical outcomes. In fact, in a draft guidance to industry, the Food and Drug Administration encouraged incorporating histologic evaluation in ulcerative colitis clinical trials. However, there is no community consensus regarding how to define mucosal healing and the field lacks standardized protocols for measuring this treatment target endpoint. Standardized assessment of histologic disease activity in clinical trials is challenging for many reasons, including variability in collection of mucosal biopsies (e.g., number and location), lack of fully validated histology scoring systems, and absence of standard definitions of histologic improvement and remission. The lack of standardized measurement of mucosal healing constitutes a major challenge for drug development and negatively impacts optimization of clinical management for patients. Therefore, the Biomarkers Consortium of the Foundation for the National Institutes of Health recently launched a consortium project, with governmental, nonprofit and industry partners, to address this gap by establishing a common methodology for a histologic measurement of mucosal healing in ulcerative colitis. The project will: 1) Establish the optimum number and locations of biopsies required to determine histological inflammation in ulcerative colitis; 2) Establish a standardized histopathologic measurement of mucosal healing that correlates with clinical outcomes; and 3) Develop an automated machine learning-based methodology for histopathological scoring of mucosal healing. The final results of this project will contribute to a consensus methodology with the goal of establishing a regulatory standard for future industry-sponsored clinical trials, with the potential to contribute to improved tools for clinical monitoring of disease activity in ulcerative colitis.

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Patel, Jaymin C., Heidi M. Soeters, Alpha Oumar Diallo, Brice W. Bicaba, Goumbi Kadadé, Assétou Y. Dembélé, Mahamat A. Acyl, et al. "MenAfriNet: A Network Supporting Case-Based Meningitis Surveillance and Vaccine Evaluation in the Meningitis Belt of Africa." Journal of Infectious Diseases 220, Supplement_4 (October 31, 2019): S148—S154. http://dx.doi.org/10.1093/infdis/jiz308.

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Abstract Meningococcal meningitis remains a significant public health threat, especially in the African meningitis belt where Neisseria meningitidis serogroup A historically caused large-scale epidemics. With the rollout of a novel meningococcal serogroup A conjugate vaccine (MACV) in the belt, the World Health Organization recommended case-based meningitis surveillance to monitor MACV impact and meningitis epidemiology. In 2014, the MenAfriNet consortium was established to support strategic implementation of case-based meningitis surveillance in 5 key countries: Burkina Faso, Chad, Mali, Niger, and Togo. MenAfriNet aimed to develop a high-quality surveillance network using standardized laboratory and data collection protocols, develop sustainable systems for data management and analysis to monitor MACV impact, and leverage the surveillance platform to perform special studies. We describe the MenAfriNet consortium, its history, strategy, implementation, accomplishments, and challenges.

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Garcia-Garcia, Hector M., Eugène P. McFadden, Andrew Farb, Roxana Mehran, Gregg W. Stone, John Spertus, Yoshinobu Onuma, et al. "Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document." Circulation 137, no. 24 (June 12, 2018): 2635–50. http://dx.doi.org/10.1161/circulationaha.117.029289.

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Swartz, M. H., J. A. Colliver, C. L. Bardes, R. Charon, E. D. Fried, and S. Moroff. "Validating the standardized-patient assessment administered to medical students in the New York City Consortium." Academic Medicine 72, no. 7 (July 1997): 619–26. http://dx.doi.org/10.1097/00001888-199707000-00014.

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LaRocca, Nicholas G., Lynn D. Hudson, Richard Rudick, Dagmar Amtmann, Laura Balcer, Ralph Benedict, Robert Bermel, et al. "The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability." Multiple Sclerosis Journal 24, no. 11 (August 11, 2017): 1469–84. http://dx.doi.org/10.1177/1352458517723718.

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Background: The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was formed by the National MS Society to develop improved measures of multiple sclerosis (MS)-related disability. Objectives: (1) To assess the current literature and available data on functional performance outcome measures (PerfOs) and (2) to determine suitability of using PerfOs to quantify MS disability in MS clinical trials. Methods: (1) Identify disability dimensions common in MS; (2) conduct a comprehensive literature review of measures for those dimensions; (3) develop an MS Clinical Data Interchange Standards Consortium (CDISC) data standard; (4) create a database of standardized, pooled clinical trial data; (5) analyze the pooled data to assess psychometric properties of candidate measures; and (6) work with regulatory agencies to use the measures as primary or secondary outcomes in MS clinical trials. Conclusion: Considerable data exist supporting measures of the functional domains ambulation, manual dexterity, vision, and cognition. A CDISC standard for MS ( http://www.cdisc.org/therapeutic#MS ) was published, allowing pooling of clinical trial data. MSOAC member organizations contributed clinical data from 16 trials, including 14,370 subjects. Data from placebo-arm subjects are available to qualified researchers. This integrated, standardized dataset is being analyzed to support qualification of disability endpoints by regulatory agencies.

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Pawlowski, Jason Mark, Tammy Wotring, and Andrew S. Kennedy. "The radiation oncology EMR as a quality and outcomes-based informatics platform: A multicenter pilot study." Journal of Clinical Oncology 34, no. 7_suppl (March 1, 2016): 168. http://dx.doi.org/10.1200/jco.2016.34.7_suppl.168.

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168 Background: Radiation oncology specific oncology information systems (OIS) are highly specialized and capture large amounts of rich data related to patient care. There is great potential to expand the utility of these systems from data collection and point-of-care documentation to platforms for radiation oncology informatics. To this end, we have begun an effort to consolidate and standardize the OIS within a large network of radiation oncology clinics. We report initial findings from a multi-center OIS standardization pilot involving five clinics. Methods: Five radiation oncology clinics were converted from a paper-based medical record to an electronic medical record (EMR) on a single instance of the OIS. Clinician-led workgroups developed best-practice EMR workflows to ensure high-quality data were input into the OIS. Database configuration, clinical workflows, and documentation were standardized to enable consortium-wide reporting and dashboarding. Results: Standardization for the five radiation oncology centers was completed in September 2014. Clinical and operational dashboards were generated including dashboards to study radiation toxicity, treatment modality utilization, time studies for each task from referral to treatment, SRS/SBRT utilization, follow-up rates, and referral patterns. Consortium-wide analysis revealed substantive differences in operational and clinical practices. For example: IMRT utilization for prostate cancer patients treated with external beam radiotherapy ranged from 83% to 100% amongst facilities; the time required to contour target volumes on 80% of patients ranged from 2 to 10 days amongst physicians; and follow-up rates ranged from 50% to 83% amongst physicians. Conclusions: Standardization and consolidation of the radiation oncology OIS significantly increased reporting capabilities to include measures based on quality, safety, and patient outcomes. Disparate practices amongst radiation oncology clinics were observed and best practices discovered. OIS consolidation and standardization was essential to develop a consortium-wide understanding of clinical and operational quality.

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Cortés-Valencia, Adrian, Saraí Ortiz-Rodríguez, Nydia Balderas-Arteaga, Andrés Catzin-Kuhlmann, Ricardo Correa-Rotter, Clicerio González-Villalpando, Aida Jiménez-Corona, et al. "The Mexican Consortium of Epidemiological Studies for the Prevention, Diagnosis, and Treatment of Chronic Kidney Disease: a review of collaborating studies." Salud Pública de México 64, no. 4, jul-ago (June 29, 2022): 434–42. http://dx.doi.org/10.21149/13101.

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Objective. To harmonize participants’ information from five epidemiological studies. Materials and methods. The Mexican Consortium of Epidemiological Studies for the Prevention, Diagnosis, and Treatment of Chronic Kidney Disease (RenMex, by its Spanish acronym) was established in 2018. RenMex is a consortium of five studies: The Mexican Teachers Cohort Study; the Mexico City Diabetes Study; the Health Workers Cohort Study; the Comitán Study; and the Salt Consumption in Mexico Study, which assessed baseline serum creatinine, albumin, and C-reactive protein, all performed with standardized techniques. Results. RenMex includes 3 133 participants, with a mean age of 44.8 years, 68.8% women, 10.8% with a previous medical diagnosis of type 2 diabetes, and 24.1% living with obesity. Conclusions. In the future, RenMex will work on more detailed analyses with each cohort allowed to opt in or out for each topic according to their individual data.

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Daudelin, Denise H., Laura E. Peterson, Lisa C. Welch, Redonna Chandler, Mridu Pandey, Farzad Noubary, Philip L. Lee, and Harry P. Selker. "Implementing Common Metrics across the NIH Clinical and Translational Science Awards (CTSA) consortium." Journal of Clinical and Translational Science 4, no. 1 (November 26, 2019): 16–21. http://dx.doi.org/10.1017/cts.2019.425.

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AbstractThe Clinical and Translational Science Award (CTSA) Consortium and the National Center for Advancing Translational Science (NCATS) undertook a Common Metrics Initiative to improve research processes across the national CTSA Consortium. This was implemented by Tufts Clinical and Translational Science Institute at the 64 CTSA academic medical centers. Three metrics were collaboratively developed by NCATS staff, CTSA Consortium teams, and outside consultants for Institutional Review Board Review Duration, Careers in Clinical and Translational Research, and Pilot Award Publications and Subsequent Funding. The implementation program included training on the metric operational guidelines, data collection, data reporting system, and performance improvement framework. The implementation team provided small-group coaching and technical assistance. Collaborative learning sessions, driver diagrams, and change packages were used to disseminate best and promising practices. After 14 weeks, 84% of hubs had produced a value for one metric and about half had produced an initial improvement plan. Overall, hubs reported that the implementation activities facilitated their Common Metrics performance improvement process. Experiences implementing the first three metrics can inform future directions of the Common Metrics Initiative and other research groups implementing standardized metrics and performance improvement processes, potentially including other National Institutes of Health institutes and centers.

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French, Dan. "Massachusetts Consortium for Innovative Education Assessments: Creating a grassroots accountability system to leverage state policy change." education policy analysis archives 26 (January 29, 2018): 16. http://dx.doi.org/10.14507/epaa.26.3442.

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Standardized testing remains the predominant proficiency measure for students and schools, placing teacher and student focus on test-prep and lower order skills while maintaining achievement gaps that penalize underserved students. The Massachusetts Consortium for Innovative Assessment seeks to close this gap and change assessment measures on a state level by training teachers to become leaders in implementing student-centered performance assessments and encouraging state legislators to consider alternative, forward-thinking accountability systems.

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Tomizawa, Daisuke, Kirk D. Wyatt, E. Anders Kolb, Dirk Reinhardt, Sarah K. Tasian, Jeffrey E. Rubnitz, C. Michel Zwaan, et al. "Collaborative data sharing: The International Acute Myeloid Leukemia Consortium (INTERACT)." Journal of Clinical Oncology 42, no. 23_suppl (August 10, 2024): 169. http://dx.doi.org/10.1200/jco.2024.42.23_suppl.169.

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169 Background: Outcomes for children and adolescents/young adults (AYAs) with acute myeloid leukemia (AML) remain suboptimal and are decidedly poor for patients with subtypes defined by high-risk features, including canonical genetic alterations and relapsed/refractory presentation. Due to their rarity, these subtypes are difficult to study within the existing clinical trials paradigm. Data sharing efforts aim to increase our understanding of rare cancer subtypes by pooling data from multiple sources. The INTERnational Acute myeloid leukemia ConsorTium (INTERACT) was established to pool and share data on pediatric and AYA patients with AML. Methods: In 2019, a data dictionary was created through an iterative, consensus-driven process that analyzed pre-existing clinical trials case report forms as the initial basis. By developing this standardized representation for data on patients with AML, data could be harmonized and integrated. A memorandum of understanding was signed in 2021, formally establishing INTERACT. An executive committee was convened to establish scientific priorities, facilitate ongoing data dictionary work, usher agreements with data contributors and review data requests submitted by investigators. In January 2024, the initial set of AML data was released on the Pediatric Cancer Data Commons (PCDC) data portal. Results: As of April 2024, the data dictionary includes 157 standardized data elements that were used to harmonize clinical data on 3,413 patients who participated in seven clinical trials conducted by four pediatric oncology cooperative groups across the United States, Europe, and Asia. Elements in the data dictionary include demographics, initial disease characteristics, genetic alterations, and survival status. Aggregate data can be freely explored using the publicly-available PCDC data portal (portal.pedscommons.org) and investigators seeking line-level access to data may submit a project request to the INTERACT executive committee for consideration. Conclusions: International collaborative data-sharing efforts will advance our understanding of pediatric and AYA AML by reducing barriers that constrain our study of AML to smaller cohorts of data. We hope that an early outcome of data sharing will be to increase our understanding of optimal treatments for patients with relapsed/refractory disease. Future goals of INTERACT include identifying data from additional studies to include, establishing relationships with new data contributors, and establishing working groups to advance the consortium’s scientific and clinical trials goals.

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Ashton, Emily. "I’ve got my EYE on you: Schooled Readiness, Standardized Testing, and Developmental Surveillance." Journal of Childhood Studies 39, no. 1 (December 30, 2014): 3–24. http://dx.doi.org/10.18357/jcs.v39i1.15243.

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In recent years early learning and child care (ELCC) has become a significant priority area for many provincial governments, including New Brunswick (NB). The NB consortium perceives ELCC as instrumental to achieving broader economic prosperity and social well-being. In hopes of problematizing rather than normalizing the contemporary spotlight on ELCC, I interrogate how school readiness has become the selectively targeted problem for which pre-school developmental testing is proposed as the solution. The specific means purported to address school readiness in NB is the Early Years Evaluation – Direct Assessment (EYE-DA). While EYE-DA testing is ongoing and powerful, I conclude that the recent pan-Canadian uptake of curriculum frameworks and pedagogical documentation may incite counter possibilities and provocations for those of us working with young children.

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Richter, Ines, Holger Thiele, and Mohamed Abdel-Wahab. "Durability of Transcatheter Heart Valves: Standardized Definitions and Available Data." Journal of Clinical Medicine 10, no. 18 (September 16, 2021): 4180. http://dx.doi.org/10.3390/jcm10184180.

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Transcatheter aortic valve replacement is a well-established alternative to surgical aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis. Currently, this technique is shifting towards younger patient groups with intermediate- and low-risk profile, which raises the question about long-term durability. Despite acceptable results up to 5 years, little is currently known about valve performance beyond 5 years. Since valve deterioration, thrombosis and endocarditis seem to be the main factors affecting valve durability, precise and widely accepted definitions of these parameters were stated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in 2017, followed by the Valve in Valve International Data (VIVID) group definitions in 2018 and the Valve Academic Research Consortium 3 (VARC-3) definitions in 2021. Until the introduction of these definitions, interstudy comparisons were difficult due to missing uniformity. Since the release of these recommendations, an increasing number of studies have reported their data on long-term durability using these new criteria. The aim of the present article is to discuss the current definitions on bioprosthetic valve durability, and to summarize the available data on long-term durability of transcatheter aortic valves.

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Kim, Ju Yeong, Evan Henrich, Helen Miller, Mike Jiang, Jake Wagner, Greg Finak, and Raphael Gottardo. "ImmuneSpace enables multicohort immune correlates analysis." Journal of Immunology 204, no. 1_Supplement (May 1, 2020): 159.12. http://dx.doi.org/10.4049/jimmunol.204.supp.159.12.

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Abstract ImmuneSpace is a data repository and analysis platform of the Human Immunology Project Consortium (HIPC), a multi-center collaborative effort to characterize the status of the immune system in different populations under diverse stimulations and disease states. This ongoing effort has generated large amounts of varied high-throughput, high-dimensional immunological data. ImmuneSpace directly extracts data from ImmPort -- the central NIAID database, and further standardizes it for meta-analysis and reporting, making it ready to be explored using state-of-art visualization and analysis tools. ImmuneSpace will act as a central immunological hub, allowing experimentalists, statisticians, and bioinformaticians to freely retrieve, explore and compare data across assays and across studies generated within and outside of HIPC. We present a selection of multi-cohort analyses using standardized gene expression and flow cytometry data sets across multiple studies identifying novel baseline predictors of vaccine efficacy across a variety of pathogens.

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Johnson, Marcus R., Merritt Raitt, Aliya Asghar, Debra L. Condon, Danielle Beck, and Grant D. Huang. "Development and implementation of standardized study performance metrics for a VA healthcare system clinical research consortium." Contemporary Clinical Trials 108 (September 2021): 106505. http://dx.doi.org/10.1016/j.cct.2021.106505.

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26

Reiss, I., T. Schaible, L. van den Hout, I. Capolupo, K. Allegaert, A. van Heijst, M. Gorett Silva, A. Greenough, and D. Tibboel. "Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus." Neonatology 98, no. 4 (2010): 354–64. http://dx.doi.org/10.1159/000320622.

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27

Zhao, Hui, Lindsay Mullins, Andra Davis, Kathryn Sexson, and Sara Hart. "EARLY OUTCOMES OF A NATIONAL CONSORTIUM TO ADVANCE FAMILY CAREGIVERS IN NURSING EDUCATION." Innovation in Aging 6, Supplement_1 (November 1, 2022): 759–60. http://dx.doi.org/10.1093/geroni/igac059.2756.

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Abstract Family caregivers (FCGs) hold primary responsibility in caring for people with chronic illness often with little training and insufficient resources Standardized guidance for supporting FCGs currently does not exist. Given this fact, it is an urgent call to healthcare professionals, particularly nurses as the key members of the healthcare team, to promote education for FCGs. In April 2022, experts in the field of family caregiving from UC Davis and University of Utah schools of nursing, convened educators and champions of FCGs from across the country and formed the Family Caregiving Nursing Education Consortium to advance the inclusion of FCGs in nursing education in order to address the lack of standardized nursing competencies for family caregiving. The consortium consists of members from nine diverse universities representing member expertise in pediatrics, geriatrics, palliative care, disabilities, mental health, and underserved communities in order to address a broader range of health issues through the lifespan. Preliminary data were reviewed and identified as a framework, including Family Caregiver Competencies for Interprofessional Education (4 domains) developed by the school of nursing at UC Davis and the AACN Essentials (10 competency categories). Members mapped the family caregiving competencies to the AACN Essentials (2021) during monthly meetings. Though current work presented an early-stage outcome, it marched through crucial steps, including institutional environmental scans, needs assessments, and toolkit development, as building blocks that not only advanced the inclusion of family caregiving education in nursing curricula but also provided foundation to guide the next stage of work.

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Tariot, Pierre N. "CERAD Behavior Rating Scale for Dementia." International Psychogeriatrics 8, S3 (May 1997): 317–20. http://dx.doi.org/10.1017/s1041610297003542.

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In the absence of a standardized technique for reliably and comprehensively describing changes in behavioral disturbances of dementia, the Behavioral Pathology Committee of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) sought to develop a scale that could be used to evaluate a wide range of psychopathologic signs and symptoms in patients with differing severity of dementia. The goal of the committee was to develop a scale composed of well-anchored, homogeneously scaled items that could be administered by interviewers without extensive psychiatric training.

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Jackenkroll, Markus. "Optimizing precision agricultural operations by standardized cloud-based functions." Spanish Journal of Agricultural Research 19, no. 4 (December 2021): e0212-e0212. http://dx.doi.org/10.5424/sjar/2021194-17774.

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Aim of study: An approach to integrate knowledge into the IT-infrastructure of precision agriculture (PA) is presented. The creation of operation relevant information is analyzed and explored to be processed by standardized web services and thereby to integrate external knowledge into PA. The target is to make knowledge integrable into any software solution. Area of study: The data sampling took place at the Heidfeld Hof Research Station in Stuttgart, Germany. Material and methods: This study follows the information science’s idea to separate the process from data sampling into the final actuation through four steps: data, information, knowledge, and wisdom. The process from the data acquisition, over a professional data treatment to the actual application is analyzed by methods modelled in the Unified Modelling Language (UML) for two use-cases. It was further applied for a low altitude sensor in a PA operation; a data sampling by UAV represents the starting point. Main results: For the implemented solution, the Web Processing Service (WPS) of the Open Geospatial Consortium (OGC) is proposed. This approach reflects the idea of a function as a service (FaaS), in order to develop a demand-driven and extensible solution for irregularly used functionalities. PA benefits, as on-farm processes are season oriented and a FaaS reflects the farm’s variable demands over time by origin and extends the concept to offer external know-how for the integration into specific processes. Research highlights: The standardized implementation of knowledge into PA software products helps to generate additional benefits for PA.

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Hoxby, H. "Optimizing technologies in nurse practitioner education." Journal of Telemedicine and Telecare 6, no. 2_suppl (August 2000): 30–32. http://dx.doi.org/10.1258/1357633001935464.

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A provincial educational programme was launched in 1995 for primary-care nurse practitioners. A consortium of Ontario university schools of nursing joined forces to provide a single, standardized educational programme at all 10 sites in both official languages. This demanding, clinically focused educational initiative required better access, support and efficiencies than could be provided by print copies and videoconferences alone. The development of a password-protected Website allowed equal access for all and maximized the human and financial resources. Optimizing various technologies has enhanced the quality and efficiencies of the nurse practitioner programme.

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Kappetein, A. Pieter, Stuart J. Head, Philippe Généreux, Nicolo Piazza, Nicolas M. van Mieghem, Eugene H. Blackstone, Thomas G. Brott, et al. "Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document#." EuroIntervention 8, no. 7 (November 2012): 782–95. http://dx.doi.org/10.4244/eijv8i7a121.

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Benjamin, Evan M. "Using Hospital Standardized Mortality Ratios for Public Reporting: A Comment by the Consortium of Chief Quality Officers." American Journal of Medical Quality 24, no. 2 (November 4, 2008): 164–65. http://dx.doi.org/10.1177/1062860608326543.

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Kappetein, A. Pieter, Stuart J. Head, Philippe Généreux, Nicolo Piazza, Nicolas M. van Mieghem, Eugene H. Blackstone, Thomas G. Brott, et al. "Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document†." European Heart Journal 33, no. 19 (October 2012): 2403–18. http://dx.doi.org/10.1093/eurheartj/ehs255.

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Kappetein, A. Pieter, Stuart J. Head, Philippe Généreux, Nicolo Piazza, Nicolas M. van Mieghem, Eugene H. Blackstone, Thomas G. Brott, et al. "Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document." Journal of Thoracic and Cardiovascular Surgery 145, no. 1 (January 2013): 6–23. http://dx.doi.org/10.1016/j.jtcvs.2012.09.002.

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Burns, Daniel J. P., Jason Arora, Oluwakemi Okunade, John F. Beltrame, Sabrina Bernardez-Pereira, Marisa G. Crespo-Leiro, Gerasimos S. Filippatos, et al. "International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients." JACC: Heart Failure 8, no. 3 (March 2020): 212–22. http://dx.doi.org/10.1016/j.jchf.2019.09.007.

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Campbell, Christopher T., Kristin H. Wheatley, Leanne Svoboda, Courtney E. Campbell, and Kelley R. Norris. "Strategies for Implementing Pediatric Dose Standardization: Considerations From the Vizient University Health System Consortium Pharmacy Network Pediatric Pharmacy Committee." Journal of Pediatric Pharmacology and Therapeutics 27, no. 1 (December 22, 2021): 19–28. http://dx.doi.org/10.5863/1551-6776-27.1.19.

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Pediatric patients are at a heightened risk for medication errors due to variability in medication ordering and administration. Dose rounding and standardization have been 2 practices historically used to reduce variability and improve medication safety. This article will describe strategies for implementing pediatric dose standardization. Local practice often dictates the operational decisions made at an institutional level, leading to a lack of a standard methodology. Vizient survey results demonstrate there is wide variation in dose standardization and ready-to-use (RTU) practices although most responding institutions have attempted to limit bedside manipulation to reduce medication error. There are many barriers to consider before pursuing dose standardization at an institution. These include selecting medications to standardize, calculating appropriate standardized doses, preparing RTU products, and supplying the products to the patient. Strategies to overcome implementation issues are described as well as identification of knowledge gaps related to the preparation and use of RTU products in the pediatric population. There is opportunity to enhance an institution's ability to provide RTU medications. Although there are several barriers, those that have had successful implementation have leveraged their information technology systems, garnered multidisciplinary support, and customized their practice to meet their operational demands.

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37

Etges, Ana Paula Beck da Silva, Luciana Paula Cadore Stefani, Dionisios Vrochides, Junaid Nabi, Carisi A. Polanczyk, and Richard D. Urman. "A Standardized Framework for Evaluating Surgical Enhanced Recovery Pathways: A Recommendations Statement from the TDABC in Health-care Consortium." Journal of Health Economics and Outcomes Research 8, no. 1 (June 24, 2021): 116–24. http://dx.doi.org/10.36469/jheor.2021.24590.

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Background: Innovative methodologies to redesign care delivery are being applied to increase value in health care, including the creation of enhanced recovery pathways (ERPs) for surgical patients. However, there is a lack of standardized methods to evaluate ERP implementation costs. Objectives: This Recommendations Statement aims to introduce a standardized framework to guide the economic evaluation of ERP care-design initiatives, using the Time-Driven Activity-Based Costing (TDABC) methodology. Methods: We provide recommendations on using the proposed framework to support the decision-making processes that incorporate ERPs. Since ERPs are usually composed of activities distributed throughout the patient care pathway, the framework can demonstrate how the TDABC may be a valuable method to evaluate the incremental costs of protocol implementation. Our recommendations are based on the review of available literature and expert opinions of the members of the TDABC in Healthcare Consortium. Results: The ERP framework, composed of 11 steps, was created describing how the techniques and methods can be applied to evaluate the economic impact of an ERP and guide health-care leaders to optimize the decision-making process of incorporating ERPs into health-care settings. Finally, six recommendations are introduced to demonstrate that using the suggested framework could increase value in ERP care-design initiatives by reducing variability in care delivery, educating multidisciplinary teams about value in health, and increasing transparency when managing surgical pathways. Conclusions: Our proposed standardized framework can guide decisions and support measuring improvements in value achieved by incorporating the perioperative redesign protocols.

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Stratigos, Alexander J., Maria Concetta Fargnoli, Arcangela De Nicolo, Ketty Peris, Susana Puig, Efthymia Soura, Chiara Menin, et al. "MelaNostrum: a consensus questionnaire of standardized epidemiologic and clinical variables for melanoma risk assessment by the melanostrum consortium." Journal of the European Academy of Dermatology and Venereology 32, no. 12 (September 14, 2018): 2134–41. http://dx.doi.org/10.1111/jdv.15208.

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39

Johannesson, Liza, Giuliano Testa, Rebecca Flyckt, Ruth Farrell, Cristiano Quintini, Anji Wall, Kathleen O'Neill, et al. "Guidelines for standardized nomenclature and reporting in uterus transplantation: An opinion from the United States Uterus Transplant Consortium." American Journal of Transplantation 20, no. 12 (May 22, 2020): 3319–25. http://dx.doi.org/10.1111/ajt.15973.

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40

Kovács, G., L. Tagliaferri, R. Autorino, N. Dinapoli, R. Gatta, V. Lanzotti, M. A. Gambacorta, A. Damiani, and V. Valentini. "PO-1031: ENT COBRA (COnsortium for BRachytherapy data Analysis) : Standardized data collection (SDC) for H&N patients." Radiotherapy and Oncology 115 (April 2015): S555—S556. http://dx.doi.org/10.1016/s0167-8140(15)41023-0.

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41

Snoek, Kitty G., Irwin K. M. Reiss, Anne Greenough, Irma Capolupo, Berndt Urlesberger, Lucas Wessel, Laurent Storme, et al. "Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update." Neonatology 110, no. 1 (2016): 66–74. http://dx.doi.org/10.1159/000444210.

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Ahuis, Tim P., Magdalena K. Smyk, Clément Laloux, Katharina Aulehner, Jack Bray, Ann-Marie Waldron, Nina Miljanovic, et al. "Evaluation of variation in preclinical electroencephalographic (EEG) spectral power across multiple laboratories and experiments: An EQIPD study." PLOS ONE 19, no. 10 (October 29, 2024): e0309521. http://dx.doi.org/10.1371/journal.pone.0309521.

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The European Quality In Preclinical Data (EQIPD) consortium was born from the fact that publications report challenges with the robustness, rigor, and/or validity of research data, which may impact decisions about whether to proceed with further preclinical testing or to advance to clinical testing, as well as draw conclusions on the predictability of preclinical models. To address this, a consortium including multiple research laboratories from academia and industry participated in a series of electroencephalography (EEG) experiments in mice aimed to detect sources of variance and to gauge how protocol harmonisation and data analytics impact such variance. Ultimately, the goal of this first ever between-laboratory comparison of EEG recordings and analyses was to validate the principles that supposedly increase data quality, robustness, and comparability. Experiments consisted of a Localisation phase, which aimed to identify the factors that influence between-laboratory variability, a Harmonisation phase to evaluate whether harmonisation of standardized protocols and centralised processing and data analysis reduced variance, and a Ring-Testing phase to verify the ability of the harmonised protocol to generate consistent findings. Indeed, between-laboratory variability reduced from Localisation to Harmonisation and this reduction remained during the Ring-Testing phase. Results obtained in this multicentre preclinical qEEG study also confirmed the complex nature of EEG experiments starting from the surgery and data collection through data pre-processing to data analysis that ultimately influenced the results and contributed to variance in findings across laboratories. Overall, harmonisation of protocols and centralized data analysis were crucial in reducing laboratory-to-laboratory variability. To this end, it is recommended that standardized guidelines be updated and followed for collection and analysis of preclinical EEG data.

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Santos, George F., R. Randall Deck, John Donnelly, William Blackwelder, and Dan M. Granoff. "Importance of Complement Source in Measuring Meningococcal Bactericidal Titers." Clinical Diagnostic Laboratory Immunology 8, no. 3 (May 1, 2001): 616–23. http://dx.doi.org/10.1128/cdli.8.3.616-623.2001.

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ABSTRACT Complement-mediated bactericidal antibodies in serum confer protection against meningococcal disease. The minimum protective titer is estimated to be between 1:4 and 1:8 when measured by the Goldschneider assay performed with human complement, the assay used in the 1960s to establish the correlation between bactericidal antibodies and protection. A more recently described bactericidal assay standardized by an international consortium uses rabbit complement, which is known to augment bactericidal titers. To define a protective titer measured by the standardized assay, we compared bactericidal titers against serogroup C strains measured by this assay to titers measured by the assay described by Goldschneider et al. A titer of ≥1:128 measured by the standardized assay was needed to predict with ≥80% certainty a positive titer of ≥1:4 as measured by the Goldschneider assay. However, the majority of samples with titers of 1:4 measured by the Goldschneider assay had titers of <1:128 when measured by the standardized assay. Therefore, by the results of the standardized assay such persons would be falsely categorized as being susceptible to disease. In conclusion, high bactericidal titers measured with the standardized assay performed with rabbit complement are predictive of protection, but no threshold titer is both sensitive and specific for predicting a positive titer measured by the Goldschneider assay using human complement. Up to 10% of the U.S. adult population lacks intrinsic bactericidal activity against serogroup C strains in serum and can serve as complement donors. Therefore, use of the Goldschneider assay or an equivalent assay performed with human complement is preferred over assays that use rabbit complement.

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Drabent, Alexander, Oliver Freyermuth, Manuel Giffels, Matthias Hoeft, Jörn Künsemöller, Benoit Roland, Dominik Schwarz, and Christoph Wissing. "Federated Heterogeneous Compute and Storage Infrastructure for the PUNCH4NFDI Consortium." EPJ Web of Conferences 295 (2024): 07020. http://dx.doi.org/10.1051/epjconf/202429507020.

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PUNCH4NFDI, funded by the Germany Research Foundation initially for five years, is a diverse consortium of particle, astro-, astroparticle, hadron and nuclear physics embedded in the National Research Data Infrastructure initiative. In order to provide seamless and federated access to the huge variety of compute and storage systems provided by the participating communities covering their very diverse needs, the Compute4PUNCH and Storage4PUNCH concepts have been developed. Both concepts comprise state-of-the-art technologies such as a token-based AAI for standardized access to compute and storage resources. The community supplied heterogeneous HPC, HTC and Cloud compute resources are dynamically and transparently integrated into one federated HTCondorbased overlay batch system using the COBalD/TARDIS resource meta-scheduler. Traditional login nodes and a JupyterHub provide entry points into the entire landscape of available compute resources, while container technologies and the CERN Virtual Machine File System (CVMFS) ensure a scalable provisioning of community-specific software environments. In Storage4PUNCH, community supplied storage systems mainly based on dCache or XRootD technology are being federated in a common infrastructure employing methods that are well established in the wider HEP community. Furthermore existing technologies for caching as well as metadata handling are being evaluated with the aim for a deeper integration. The combined Compute4PUNCH and Storage4PUNCH environment will allow a large variety of researchers to carry out resource-demanding analysis tasks. In this contribution we will present the Compute4PUNCH and Storage4PUNCH concepts, the current status of the developments as well as first experiences with scientific applications being executed on the available prototypes.

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Kapsner, Lorenz A., Jonathan M. Mang, Sebastian Mate, Susanne A. Seuchter, Abishaa Vengadeswaran, Franziska Bathelt, Noemi Deppenwiese, Dennis Kadioglu, Detlef Kraska, and Hans-Ulrich Prokosch. "Linking a Consortium-Wide Data Quality Assessment Tool with the MIRACUM Metadata Repository." Applied Clinical Informatics 12, no. 04 (August 2021): 826–35. http://dx.doi.org/10.1055/s-0041-1733847.

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Abstract Background Many research initiatives aim at using data from electronic health records (EHRs) in observational studies. Participating sites of the German Medical Informatics Initiative (MII) established data integration centers to integrate EHR data within research data repositories to support local and federated analyses. To address concerns regarding possible data quality (DQ) issues of hospital routine data compared with data specifically collected for scientific purposes, we have previously presented a data quality assessment (DQA) tool providing a standardized approach to assess DQ of the research data repositories at the MIRACUM consortium's partner sites. Objectives Major limitations of the former approach included manual interpretation of the results and hard coding of analyses, making their expansion to new data elements and databases time-consuming and error prone. We here present an enhanced version of the DQA tool by linking it to common data element definitions stored in a metadata repository (MDR), adopting the harmonized DQA framework from Kahn et al and its application within the MIRACUM consortium. Methods Data quality checks were consequently aligned to a harmonized DQA terminology. Database-specific information were systematically identified and represented in an MDR. Furthermore, a structured representation of logical relations between data elements was developed to model plausibility-statements in the MDR. Results The MIRACUM DQA tool was linked to data element definitions stored in a consortium-wide MDR. Additional databases used within MIRACUM were linked to the DQ checks by extending the respective data elements in the MDR with the required information. The evaluation of DQ checks was automated. An adaptable software implementation is provided with the R package DQAstats. Conclusion The enhancements of the DQA tool facilitate the future integration of new data elements and make the tool scalable to other databases and data models. It has been provided to all ten MIRACUM partners and was successfully deployed and integrated into their respective data integration center infrastructure.

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Corusa, Andreas, and Ilaria Losa. "Methodology for evaluating the replicability of European energy solutions in global contexts." ECONOMICS AND POLICY OF ENERGY AND THE ENVIRONMENT, no. 2 (November 2024): 87–107. https://doi.org/10.3280/efe2024-002005.

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Platone (Platone Consortium, 2020) was a four-year Horizon 2020 funded European project that aimed at defining new approaches to increase the observability of renewable energy resources and loads to exploit their flexibility. It developed advanced management open-source platforms to unlock grid flexibility and to realize an open and non-discriminatory market, linking users, aggregators, and operators. These platforms were tested in three pilot projects in Italy (Platone Consortium, 2021), Greece (Platone Consortium, 2023) and Germany (Platone Consortium, 2021) and allow to integrate solutions like: Local Energy Communities, Virtual Power Plants (VPPs) supporting Distribution System Operators (DSOs), FlexibilityBased Reinforcement Planning, and Flexibility Provision by Distributed Resources. The results of pilot projects were complemented by an analysis of the Scalability and Replicability Analysis (SRA) potential of the most promising solutions tested in the demos in the European context (Platone consortium, 2023). The present paper expands the Platone project's insights into a comprehensive methodology for evaluating the replicability potential of solutions developed in the 3 pilot projects in Extra European contexts, notably Canada. By integrating quantitative insights with empirical evidence from pilot projects across Italy, Greece, and Germany, the proposed approach highlights the critical interplay between technical innovation, regulatory adaptability, and stakeholder engagement. The analysis was performed with a qualitative approach. First, a literature review of the similar approaches developed by other European projects that allows to identify the technical, regulatory, and stakeholder acceptance issues that impact on the SRA potential of the Platone solutions. These elements were used to elaborate an ad hoc questionnaire that was distributed among the list of stakeholders of Canadian experts identified by the Northern Alberta Institute of Technology. The survey highlights key insights and recommendations for deploying innovative energy solutions in Canada, such as VPPs and Flexibility-based Reinforcement Planning. Challenges include technical hurdles, like the deployment of Advanced Metering Infrastructure, and regulatory barriers across Canadian regions affecting distributed energy resources (DER) participation and energy trading. To overcome these obstacles, strategies such as comprehensive cost-benefit analysis, strengthened data privacy, standardized practices, regulatory alignment, increased stakeholder awareness, and supportive government policies are essential. Addressing these challenges can pave the way for successful integration of these solutions into Canada's energy framework, contributing to a sustainable and resilient energy system.

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Phiri, Sam, Joe Gumulira, Hannock Tweya, Lameck Chinula, Agnes Moses, Bongani Kaimila, Christopher Stanley, et al. "The Malawi Cancer Consortium – Catalyzing Cancer Care and Research in Southern Africa." Journal of Global Oncology 2, no. 3_suppl (June 2016): 3s—4s. http://dx.doi.org/10.1200/jgo.2016.003780.

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Abstract 68 Background: Cancer burden is increasing in Malawi, particularly for HIV-associated malignancies. Methods: With support from the National Cancer Institute, the Malawi Cancer Consortium (MCC) was initiated in September 2014. Partners include the UNC Lineberger Comprehensive Cancer Center, Malawi Ministry of Health, University of Malawi College of Medicine, and Lighthouse Trust. Spanning Malawi’s two major cities, Lilongwe and Blantyre, MCC includes three support cores (administration, analysis, mentoring) and three multi-institution research projects: (1) a national HIV-cancer match study to assess cancer incidence in the ART era; (2) a longitudinal cohort to identify clinical and molecular correlates of KS chemotherapy response; and (3) a longitudinal cohort to elucidate lymphoma biology and develop better treatments for HIV-associated lymphoma. Results: For project 1, 65,500 records from the Malawi National Cancer Registry and Malawi HIV cohorts have been abstracted, and initial data harmonization completed. Record linkage is planned for February 2016, will be updated at regular intervals, and will contribute to regional analyses through the IeDEA- Southern Africa network. For project 2, KS studies through MCC have led to descriptions of KS biologic subtypes defined by viral gene expression profiling, and detailed characterization of multicentric Castleman disease. Malawi has also led enrollment into multinational phase III KS clinical trials implemented by the AIDS Clinical Trials Group and AIDS Malignancy Consortium. For project 3, more than 300 adults and children with lymphoma have been enrolled since June 2014, with approximately 2/3 of adults being HIV-infected. Patients receive standardized treatment and supportive care, and standardized clinical and laboratory evaluations. Specimen-based correlative studies (virologic, genomic, biomarker studies) are ongoing. Finally, the consortium provides a platform for pilot studies in breast and esophageal cancer, and facilitates career development for Malawian cancer investigators. Conclusions: MCC has initiated a national coalition to address cancer in Malawi, and continued progress is anticipated. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Sam Phiri No relationship to disclose Joe Gumulira No relationship to disclose Hannock Tweya No relationship to disclose Lameck Chinula No relationship to disclose Agnes Moses No relationship to disclose Bongani Kaimila No relationship to disclose Christopher Stanley No relationship to disclose Edwards Kasonkanji No relationship to disclose Steady Chasimpha No relationship to disclose Richard Nyasosela No relationship to disclose Leo Masamba No relationship to disclose Tamiwe Tomoka No relationship to disclose Steve Kamiza No relationship to disclose Mina Hosseinipour No relationship to disclose Nora Rosenberg Research Funding: NIH/NCI Ron Mataya No relationship to disclose Charles Dzamalala No relationship to disclose George Liomba No relationship to disclose Irving Hoffman No relationship to disclose Dirk Dittmer No relationship to disclose Yuri Fedoriw Honoraria: Alexion Pharmaceuticals Blossom Damania No relationship to disclose Satish Gopal No relationship to disclose

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48

Lion, Thomas, Marcel Tilanus, Hélène Cavé, Mark Lawler, Anna Serra, Andrea Biondi, Jacques van Dongen, et al. "The EuroChimerism Concept for a Standardized Approach to Chimerism Analysis Following Allogeneic Stem Cell Transplantation." Blood 108, no. 11 (November 16, 2006): 621. http://dx.doi.org/10.1182/blood.v108.11.621.621.

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Abstract Transplantation of hematopoietic stem cells from related and unrelated donors is becoming an increasingly important approach in the successful treatment of different malignant and non-malignant disorders. There is thus growing demand for clinical diagnostic methodologies permitting the surveillance of chimerism during the post-transplant period. The techniques currently employed are rather heterogeneous, rendering uniform evaluation and comparison of diagnostic results between centers difficult. Leading laboratories from ten European countries have therefore performed a collaborative study supported by a grant from the European Commission, the EuroChimerism Concerted Action. The aim of this Concerted Action was the development of a standardized diagnostic methodology for the detection and monitoring of chimerism in patients undergoing allogeneic stem cell transplantation. A set of microsatellite markers, selected on the basis of their excellent performance in chimerism analysis at the reference centers involved, have been carefully evaluated and optimized for quantitative chimerism testing under standardized experimental conditions. A EuroChimerism panel designed to optimally meet the specific requirements of quantitative chimerism analysis was established utilizing 13 markers (D2S1360, D7S1517, D8S1132, D9S1118, D10S2325, D11S554, D12S1064, D12S391, D17S1290, D19S253, MYCL1, P450CYP19 and SE-33), which best satisfied the criteria of the EuroChimerism consortium. Individual microsatellites from the panel can be analyzed in multiplex reactions to facilitate the identification of one or more markers optimally suited for the monitoring of chimerism during the post-transplant period. Extensive testing of related individuals (>500 pairs) revealed that the EuroChimerism marker panel will provide at least two informative markers which meet the stringent criteria of eligibility defined by the EuroChimerism consortium (Watzinger et al., Leukemia 2006) in >99% of all patient/donor constellations. In addition to the outstanding informativeness of the marker panel, chimerism testing by singleplex assays permitted sensitive detection of residual cells of patient or donor origin at levels ranging between 0.8–1.6% in about 90% of instances. The assay also facilitates accurate and reproducible quantification of donor and recipient hematopoietic cells in peripheral blood or bone marrow specimens and in specific cell lineages isolated by flow-sorting. The precision in determining the relative contribution of donor/recipient cell populations to mixed chimerism was high within the range between 10–90% donor- or recipient-derived cells, while there was a tendency to overestimate the percentage of the subdominant cell population within the range between 1–10%. Wide use of the EuroChimerism assay will provide a basis for international standardization of chimerism testing, which will ultimately contribute to improved clinical management of patients undergoing allogeneic stem cell transplantation.

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49

Ison, Juliana M., Elizabeth W. Karlson, Jonathan D. Jackson, Alexander Hille, Cheryl McCloud, Meg Bor, Guohai Zhou, and Cheryl R. Clark. "Care and Precision Medicine Research in the Time of COVID-19." Ethnicity & Disease 31, no. 3 (July 15, 2021): 407–10. http://dx.doi.org/10.18865/ed.31.3.407.

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Purpose: Enhancing the bidirectional benefit of precision medicine research infrastructure may advance equity in research participation for diverse groups. This study explores the use of research infrastructure to provide human-centered COVID-19 resources to participants as a part of their research participation.Design: The All of Us New England (AoUNE) consortium research team developed standardized check-in telephone calls to ask participants about their well-being and share COVID-19 resources.Participants: A total of 20,559 participants in the AoUNE consortium received a COVID-19 check-in call.Methods: Research assistants called participants during March-April 2020, distributed COVID-19 resources to interested participants, and subsequently rated call tone.Results: Of the total cohort participants called, 8,512 (41%) spoke with a research team member. The majority of calls were rated as positive or neutral; only 3% rated as negative. African American and Black as well as Hispanic populations requested COVID-19 resources at higher rates than other groups.Conclusion: Calls made to AoUNE participants were received positively by diverse groups. These findings may have implications for participant-centered engagement strategies in precision medicine research.Ethn Dis. 2021;31(3):407-410; doi:10.18865/ed.31.3.407

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50

Carey, Megan E., Zoe A. Dyson, Silvia Argimón, Louise Cerdeira, Corin Yeats, David Aanensen, Gerald Mboowa, et al. "Unlocking the Potential of Genomic Data to Inform Typhoid Fever Control Policy: Supportive Resources for Genomic Data Generation, Analysis, and Visualization." Open Forum Infectious Diseases 10, Supplement_1 (May 2023): S38—S46. http://dx.doi.org/10.1093/ofid/ofad044.

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Abstract The global response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic demonstrated the value of timely and open sharing of genomic data with standardized metadata to facilitate monitoring of the emergence and spread of new variants. Here, we make the case for the value of Salmonella Typhi (S. Typhi) genomic data and demonstrate the utility of freely available platforms and services that support the generation, analysis, and visualization of S. Typhi genomic data on the African continent and more broadly by introducing the Africa Centres for Disease Control and Prevention's Pathogen Genomics Initiative, SEQAFRICA, Typhi Pathogenwatch, TyphiNET, and the Global Typhoid Genomics Consortium.

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