Consortium-based Approach Research Articles

Effect of menstrual cycle and contraceptive pill phase on aspects of exercise physiology and athletic performance in female athletes: protocol for the Feminae international multisite innovative project

The idiom ‘more high-quality research is needed’ has become the slogan for sport and exercise physiology-based research in female athletes. However, in most instances, it is challenging to address this...

Enhancing plant defense using rhizobacteria in processing tomatoes: a bioprospecting approach to overcoming Early Blight and Alternaria toxins.

Plant growth-promoting rhizobacteria (PGPR) with antagonistic activity toward plant pathogenic fungi are valuable candidates for the development of novel plant protection products based on biocontrol activity. The very first step in the formulation of such products is to screen the potential effectiveness of the selected microorganism(s). In this study, non-pathogenic rhizobacteria were isolated from the rhizosphere of tomato plants and evaluated for their biocontrol activity against three species of mycotoxin-producing Alternaria. The assessment of their biocontrol potential involved investigating both fungal biomass and Alternaria toxin reduction. A ranking system developed allowed for the identification of the 12 best-performing strains among the initial 85 isolates. Several rhizobacteria showed a significant reduction in fungal biomass (up to 76%) and/or mycotoxin production (up to 99.7%). Moreover, the same isolates also demonstrated plant growth-promoting (PGP) traits such as siderophore or IAA production, inorganic phosphate solubilization, and nitrogen fixation, confirming the multifaceted properties of PGPRs. Bacillus species, particularly B. amyloliquefaciens and two strains of B. subtilis, showed the highest efficacy in reducing fungal biomass and were also effective in lowering mycotoxin production. Isolates such as Enterobacter ludwigii, Enterobacter asburiae, Serratia nematodiphila, Pantoea agglomerans, and Kosakonia cowanii showed moderate efficacy. Results suggest that by leveraging the diverse capabilities of different microbial strains, a consortium-based approach would provide a broader spectrum of effectiveness, thereby signaling a more encouraging resolution for sustainable agriculture and addressing the multifaceted nature of crop-related biotic challenges.

Collaborative Seismic Environment Plan (CSEP) project – a long-term, consistent, consortium-based approach to environmental approvals

The Collaborative Seismic Environment Plan (CSEP) project was formed in 2018 by NERA (National Energy Resources Australia) and an industry consortium of marine seismic acquisition operators and exploration titleholders. Using a collaborative approach, the vision of the CSEP project was to streamline seismic survey environment plan preparation, submission and assessment by the regulator (National Offshore Petroleum Environmental and Safety Authority, NOPSEMA), with an emphasis on mutually agreed protocols with commercial fishers operating within the CSEP Operational Area. Stakeholder consultation undertaken during Environmental Plan (EP) preparation was identified by the consortium as a principal cause for concern and a common reason for unsuccessful EP submissions. The CSEP project has achieved the project’s vision through: A Commercial Fishing Industry Adjustment Protocol to provide a standardised, evidence-based process to assess and provide monetary adjustment to commercial fishers for loss of catch, displacement and gear loss/damage; an Operational Protocol to provide guidance regarding improved communications with commercial fishers, including the spatial and temporal repetition and advanced notifications of seismic activities; a single overarching approvals framework for seismic activities within the CSEP Operational Area; a consistent assessment of environmental receptors, potential impacts, and management controls for seismic activities; and Improved understanding of potential cumulative impacts of seismic activities across the CSEP Operational Area. The CSEP project is an example of best practice stakeholder consultation that can be applied to offshore oil and gas and renewable energy activities.

Beyond online participant crowdsourcing: The benefits and opportunities of big team addiction science.

Participant crowdsourcing platforms (e.g., MTurk, Prolific) offer numerous advantages to addiction science, permitting access to hard-to-reach populations and enhancing the feasibility of complex experimental, longitudinal, and intervention studies. Yet these are met with equal concerns about participant nonnaivety, motivation, and careless responding, which if not considered can greatly compromise data quality. In this article, we discuss an alternative crowdsourcing avenue that overcomes these issues whilst presenting its own unique advantages-crowdsourcing researchers through big team science. First, we review several contemporary efforts within psychology (e.g., ManyLabs, Psychological Science Accelerator) and the benefits these would yield if they were more widely implemented in addiction science. We then outline our own consortium-based approach to empirical dissertations: a grassroots initiative that trains students in reproducible big team addiction science. In doing so, we discuss potential challenges and their remedies, as well as providing resources to help addiction researchers develop these initiatives. Through researcher crowdsourcing, together we can answer fundamental scientific questions about substance use and addiction, build a literature that is representative of a diverse population of researchers and participants, and ultimately achieve our goal of promoting better global health. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies.

The development of medical products that can delay or prevent progression to stage 3 type 1 diabetes faces many challenges. Of note, optimising patient selection for type 1 diabetes prevention clinical trials is hindered by significant patient heterogeneity and a lack of characterisation of the time-varying probability of progression to stage 3 type 1 diabetes in individuals positive for two or more islet autoantibodies. To meet these needs, the Critical Path Institute's Type 1 Diabetes Consortium was launched in 2017 as a pre-competitive public-private partnership between stakeholders from the pharmaceutical industry, patient advocacy groups, philanthropic organisations, clinical researchers, the National Institutes of Health and the Food and Drug Administration. The Type 1 Diabetes Consortium acquired and aggregated data from three longitudinal observational studies, Environmental Determinants of Diabetes in the Young (TEDDY), Diabetes Autoimmunity Study in the Young (DAISY) and TrialNet Pathway to Prevention (TN01), and used analysis subsets of these data to support the model-based qualification of islet autoantibodies as enrichment biomarkers for patient selection in type 1 diabetes prevention trials, including registration studies. The Type 1 Diabetes Consortium has now received a qualification opinion from the European Medicines Agency for the use of these biomarkers, a major success for the field of type 1 diabetes. This endorsement will improve product developers' ability to design clinical trials of agents intended to prevent or delay type 1 diabetes that are reduced in size and/or length, while being adequately powered.

A survey of management preferences for bladder exstrophy and cloacal anomalies among Canadian pediatric surgeons and urologists

PurposeThis study examined the current referral patterns and preferences of Canadian Association of Paediatric Surgeons (CAPS) and Pediatric Urologists of Canada (PUC) members for management of bladder exstrophy and cloacal anomalies (BECA). MethodsWe invited CAPS and PUC members to participate in an online survey using RedCap. Demographic variables, years in practice, current referral patterns and local expertise at the participants’ institution were collected. Participants’ preferences towards three distinct referral models were assessed using Likert scales: no centralization of care, centralization in one or two national centres of excellence, or a consortium-based approach. ResultsThere were 82 survey respondents (2/3 were CAPS members, 35.4% female, 72% in practice for >10 years). Although >90% of participants agreed/somewhat agreed that surgical volumes impact outcomes, 58% reported not referring out BECA patients for treatment; about 50% recognized the existence of a local dedicated expert. In terms of referral preferences, 84% of participants favoured identification of a few centres with expertise based on geographic location (a consortium-based approach), while only 7% chose a one or two national centres of excellence model. Over half of participants agreed/somewhat agreed with participating in trials of a consortium-based approach in Canada. ConclusionMost CAPS and PUC members do not refer BECA patients elsewhere for treatment. Nonetheless, most surgeons recognize the importance of volume to improve outcomes and show willingness to participate in trials to concentrate experience; most participants favour a consortium-based approach through identification of a few centres of excellence based on geographic location.

Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma.

Introduction Data supporting hypofractionated preoperative radiation therapy (RT) for patients with extremity and trunk soft tissue sarcoma (STS) are currently limited to phase II single-institution studies. We sought to understand the type and thresholds of clinical evidence required for experts to adopt hypofractionated RT as a standard-of-care option for patients with STS. Methods An electronic survey was distributed to multidisciplinary sarcoma experts. The survey queried whether data from a theoretical, multi-institutional, phase II study of 5-fraction preoperative RT could change practice. Using endpoints from RTOG 0630 as a reference, the survey also queried thresholds for acceptable local control, wound complication, and late toxicity for the study protocol to be accepted as a standard-of-care option. Responses were logged from 8/27/2020 to 9/8/2020 and summarized graphically. Results The survey response rate was 55.3% (47/85). Local control is the most important clinical outcome for sarcoma specialists when evaluating whether an RT regimen should be considered standard of care. 17% (8/47) of providers require randomized phase III evidence to consider hypofractionated preoperative RT as a standard-of-care option, whereas 10.6% (5/47) of providers already view this as a standard-of-care option. Of providers willing to change practice based on phase II data, most (78%, 29/37) would accept local control rates equivalent to or less than those in RTOG 0630, as long as the rate was higher than 85%. However, 51.3% (19/37) would require wound complication rates superior to those reported in RTOG 0630, and 46% (17/37) of respondents would accept late toxicity rates inferior to RTOG 0630. Conclusion Consensus building is needed among clinicians regarding the type and threshold of evidence needed to evaluate hypofractionated RT as a standard-of-care option. A collaborative consortium-based approach may be the most pragmatic means for developing consensus protocols and pooling data to gradually introduce hypofractionated preoperative RT into routine practice.

PNS46 Development of Consumer-Reported Outcome Measure (CROM) Standards for the Tobacco Industry with Respect to Psychometric CROM Using a Consortium-Based Approach: Methodology and Scope

In November 2018, CORESTA approved the formation of a new Task Force (TF) to establish best practices and guidelines for the integration of consumer-reported outcome measures (CROM) in tobacco regulatory research. The primary objective of the CROM TF is to provide guidance on how to identify, develop, and validate CROM, and to provide access to CROM for evaluating tobacco and nicotine-containing products for pre-market and post-market purposes. Here, we describe the research completed by one of the TF working groups, WG02, with the purpose of developing CROM standards for tobacco regulatory research with respect to psychometric CROM (i.e., CROM intended to measure underlying psychological attributes – e.g., reinforcing effects). WG02 comprises 11 researchers from the CROM TF, representing 7 different tobacco companies and with experience in psychometrics, patient-reported outcomes (PRO), survey methodology, and product use behavior. WG02 members collaboratively drafted an operational definition of psychometric CROM and devised an approach for developing the standards. Consistent with approaches taken by other outcomes research organizations WG02 adopted a consensus-based approach for drafting the standards, which includes (1) review of literature and (2) an iterative peer-review process leveraging various sources, such as conference presentation and review by subject matter experts from tobacco, PRO, and related fields. Through literature review and WG02 member input, the scope was defined and initial content for the 5 components of the standards was drafted. These components include: (1) appropriate content, (2) development process and validation, (3) adaptation/modification of existing CROM, (4) application/implementation and interpretation of CROM, and (5) linguistic/cultural translation. This research represents the development of draft standards for Psychometric CROM for tobacco regulatory research, with the intention to complement 2020 draft guidance issued by the Food and Drug Administration Center for Tobacco Products. The initial draft content is being disseminated for peer-review.

Strength in Numbers: Identifying Neoantigen Targets for Cancer Immunotherapy

Targeting cancer neoantigens generated by tumor-exclusive somatic mutations is an attractive yet challenging strategy for the robust and specific elimination of tumor cells by cellular immunotherapy. In this issue of Cell, Wells etal. describe a consortium-based approach to optimize bioinformatics pipelines to sensitively and accurately predict immunogenic neoantigens from next-generation sequencing data.

Grassroots Training for Reproducible Science: A Consortium-Based Approach to the Empirical Dissertation

There is a widely acknowledged need to improve the reliability and efficiency of scientific research to increase the credibility of the published scientific literature and accelerate discovery. Widespread improvement requires a cultural shift in both thinking and practice, and better education will be instrumental to achieve this. Here we argue that education in reproducible science should start at the grassroots. We present our model of consortium-based student projects to train undergraduates in reproducible team science. We discuss how with careful design we have aligned collaboration with the current conventions for individual student assessment. We reflect on our experiences of several years running the GW4 Undergraduate Psychology Consortium offering insights we hope will be of practical use to others wishing to adopt a similar approach. We consider the pedagogical benefits of our approach in equipping students with 21st-century skills. Finally, we reflect on the need to shift incentives to reward to team science in global research and how this applies to the reward structures of student assessment.

Complete Biosynthesis of Anthocyanins Using E. coli Polycultures.

ABSTRACTFermentation-based chemical production strategies provide a feasible route for the rapid, safe, and sustainable production of a wide variety of important chemical products, ranging from fuels to pharmaceuticals. These strategies have yet to find wide industrial utilization due to their inability to economically compete with traditional extraction and chemical production methods. Here, we engineer for the first time the complex microbial biosynthesis of an anthocyanin plant natural product, starting from sugar. This was accomplished through the development of a synthetic, 4-strain Escherichia coli polyculture collectively expressing 15 exogenous or modified pathway enzymes from diverse plants and other microbes. This synthetic consortium-based approach enables the functional expression and connection of lengthy pathways while effectively managing the accompanying metabolic burden. The de novo production of specific anthocyanin molecules, such as calistephin, has been an elusive metabolic engineering target for over a decade. The utilization of our polyculture strategy affords milligram-per-liter production titers. This study also lays the groundwork for significant advances in strain and process design toward the development of cost-competitive biochemical production hosts through nontraditional methodologies.

Consortium-Based Genetic Studies of Kawasaki Disease in Korea: Korean Kawasaki Disease Genetics Consortium.

In order to perform large-scale genetic studies of Kawasaki disease (KD) in Korea, the Korean Kawasaki Disease Genetics Consortium (KKDGC) was formed in 2008 with 10 hospitals. Since the establishment of KKDGC, there has been a collection of clinical data from a total of 1198 patients, and approximately 5 mL of blood samples per patient (for genomic deoxyribonucleic acid and plasma isolation), using a standard clinical data collection form and a nation-wide networking system for blood sample pick-up. In the clinical risk factor analysis using the collected clinical data of 478 KD patients, it was found that incomplete KD type, intravenous immunoglobulin (IVIG) non-responsiveness, and long febrile days are major risk factors for coronary artery lesions development, whereas low serum albumin concentration is an independent risk factor for IVIG non-responsiveness. In addition, we identified a KD susceptibility locus at 1p31, a coronary artery aneurysm locus (KCNN2 gene), and the causal variant in the C-reactive protein (CRP) promoter region, as determining the increased CRP levels in KD patients, by means of genome-wide association studies. Currently, this consortium is continually collecting more clinical data and genomic samples to identify the clinical and genetic risk factors via a single nucleotide polymorphism chip and exome sequencing, as well as collaborating with several international KD genetics teams. The consortium-based approach for genetic studies of KD in Korea will be a very effective way to understand the unknown etiology and causal mechanism of KD, which may be affected by multiple genes and environmental factors.

Exploring innovation in stem cell and regenerative medicine in Japan: the power of the consortium-based approach.

This article describes a recent trend in Japanese research, development and commercialization toward the application of stem cell technologies. Japan is the world's third largest economy and has a significant national presence in the pharmaceutical and biotechnology businesses; as such, stem cell R&D is abundant in the country. As indicated by the second largest share of patent applications worldwide, Japan had been expected to assert significant added value in the commercialization and industrial application of stem cell technologies; however, difficulties have impeded clinical development in this area, particularly the very small number of clinical trials and approved products for regenerative medicine or cell therapy. To address this 'Japan paradox', this report provides an overview of approaches for the commercialization of stem cell technologies in areas such as drug discovery, cell therapy and regenerative medicine, by discussing representative case examples of listed firms.

Consortium-based Approach to an Online Preceptor Development Program

To describe the implementation process of a consortium-based preceptor development program and to review completion and assessment data over the first 27 months. Five 1-hour, Web-based preceptor development modules were developed using streaming media technologies. Modules were released using a password-protected Internet site and were free to consortium-affiliated preceptors. Preceptor's institutional affiliation, module completion dates, module assessments, and continuing education credits were recorded and made available to each institution. Three hundred eighty-two preceptors completed 1489 modules. Fifty-six percent of preceptors were affiliated with more than 1 consortium institution. The number of participating preceptors per institution varied from 72 to 204. Sixty-five percent of preceptors completed all 5 modules. Preceptor satisfaction was high, with 93% agreeing with each course evaluation statement. Program cost per institution ranged from $12 to $35 per preceptor. A consortium-based approach to preceptor development is a convenient and effective means of providing required training.

Sea-Ice System Services: A Framework to Help Identify and Meet Information Needs Relevant for Observing Networks

The need for data from an Arctic observing network to help stakeholders with planning and action is generally recognized. Two key research concerns arise: (1) potential contrasts between fundamental and applied science in the design of an observing system, and (2) development of best practices to ensure that stakeholder needs both inform and can be met from such an observing system. We propose a framework based on the concept of sea-ice system services (SISS) to meet these challenges and categorize the ways in which stakeholders perceive, measure, and use sea ice. Principal service categories are (1) climate regulator, marine hazard, and coastal buffer; (2) transportation and use as a platform; (3) cultural services obtained from the “icescape”; and (4) support of food webs and biological diversity. Our research focuses on cases of ice as platform and marine hazard in Arctic Alaska. We identify the information for each SISS category that users need to track, forecast, and adapt to changes. The resulting framework can address multiple information needs and priorities, integrate information over the relevant spatio-temporal scales, and provide an interface with local knowledge. To plan for an integrated Arctic Observing Network, we recommend a consortium-based approach with the academic community as an impartial intermediary that uses the SISS concept to identify common priorities across the range of sea-ice users.