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Background: The number of children who require palliative care has been estimated to be as high as 21 million globally. Delivering effective children's palliative care (CPC) services requires accurate population-level information on current and future CPC need, but quantifying need is hampered by challenges in defining the population in need, and by limited available data. The objective of this paper is to summarise how population-level CPC need is defined, and quantified, in the literature. Methods: Scoping review performed in line with Joanna Briggs Institute methodology for scoping reviews and PRISMA-ScR guidelines. Six online databases (CINAHL, Cochrane Library, EMBASE, Medline, PsycINFO, and Web of Science), and grey literature, were searched. Inclusion criteria: literature published in English; 2008–2023 (Oct); including children aged 0–19 years; focused on defining and/or quantifying population-level need for palliative care. Results: Three thousand five hundred seventy-eight titles and abstracts initially reviewed, of which, 176 full-text studies were assessed for eligibility. Overall, 51 met the inclusion criteria for this scoping review. No universal agreement identified on how CPC need was defined in population-level policy and planning discussions. In practice, four key definitions of CPC need were found to be commonly applied in quantifying population-level need: (1) ACT/RCPCH (Association for Children with Life-Threatening or Terminal Conditions and their Families, and the Royal College of Paediatrics and Child Health) groups; (2) The 'Directory' of Life-Limiting Conditions; (3) 'List of Life-Limiting Conditions'; and (4) 'Complex Chronic Conditions'. In most cases, variations in data availability drove the methods used to quantify population-level CPC need and only a small proportion of articles incorporated measures of complexity of CPC need. Conclusion: Overall, greater consistency in how CPC need is defined for policy and planning at a population-level is important, but with sufficient flexibility to allow for regional variations in epidemiology, demographics, and service availability. Improvements in routine data collection of a wide range of care complexity factors could facilitate estimation of population-level CPC need and ensure greater alignment with how need for CPC is defined at the individual-level in the clinical setting. [ABSTRACT FROM AUTHOR]

Rationale and aim Clear and logical eligibility criteria are fundamental to the design and conduct of a systematic review. This methodological review examined the quality of reporting and application of eligibility criteria in systematic reviews published in three leading medical journals. Methods All systematic reviews in the BMJ, JAMA and T he L ancet in the years 2013 and 2014 were extracted. These were assessed using a refined version of a checklist previously designed by the authors. Results A total of 113 papers were eligible, of which 65 were in BMJ, 17 in T he L ancet and 31 in JAMA. Although a generally high level of reporting was found, eligibility criteria were often problematic. In 67% of papers, eligibility was specified after the search sources or terms. Unjustified time restrictions were used in 21% of reviews, and unpublished or unspecified data in 27%. Inconsistency between journals was apparent in the requirements for systematic reviews. Conclusions The quality of reviews in these leading medical journals was high; however, there were issues that reduce the clarity and replicability of the review process. As well as providing a useful checklist, this methodological review informs the continued development of standards for systematic reviews. [ABSTRACT FROM AUTHOR]

Natural Language Processing (NLP) has been adopted widely in clinical trial matching for its ability to process unstructured text hat is often found in electronic health records. Despite the rise n the new tools that use NLP to match patients to eligible clinical rials, the comparison of these tools is difficult due to the lack of consistency in how these tools are evaluated. The ground truth or eference that the tools use to assess results varies, making it difficult to compare the robustness of the tools against each other. This paper alarms the lack of definition and consistency of ground truth data used to evaluate such tools and suggests two ways to define a gold standard for the ground truth in small and arge-scale studies. [ABSTRACT FROM AUTHOR]

Objectives: This review aims to assess the state of the science around the potential impact of certain patient characteristics on the safety and effectiveness of in vitro fertilization (IVF).Methods: Following Cochrane Collaboration guidelines and the PRISMA statement, a comprehensive systematic review of reviews and recent primary studies examining the impact of paternal age and maternal age, smoking, and body mass index (BMI) on the safety and effectiveness of IVF was performed. Papers, published between January 2007 and June 2014, were independently reviewed and critically appraised by two researchers using published quality assessment tools for reviews and primary studies. Due to heterogeneity across papers (different study designs and patient selection criteria), a qualitative analysis of extracted information was performed.Results: Seventeen papers (ten systematic reviews and seven primary studies) were included. They comprised evidence from retrospective observational studies in which maternal age, BMI, and smoking status were explored as part of secondary analyses of larger studies. The majority of papers found that the likelihood of achieving a pregnancy was lower among women who were >40 years, had a BMI ≥ 25 and smoked. Advanced maternal age and BMI were also associated with higher rates of preterm birth and low birth weight.Conclusions: Based on available evidence, it may be appropriate to consider "maternal age" and "morbid obesity" in public funding policies that aim to maximize the effectiveness of IVF. However, given inconsistencies in the effect of smoking across different pregnancy-related outcomes, support for incorporating it into funding conditions appears weak. [ABSTRACT FROM AUTHOR]

This study adopted content analysis to examine policy papers concerning the eligibility requirements of the Minimum Living Standard Scheme (MLSS) in China's 31 capital cities. It was found that local officials not only assess applicants’ assets and incomes, but also their living space, quality of home decoration, possession of luxury goods, leisure activities, and behavior. The local governments’ use of a lifestyle assessment approach is caused by financial constraints and the lack of an effective mechanism to check applicants’ incomes. The lifestyle approach leads to regional inequalities in accessing public assistance, because some of the terms, which define the quality of life, are too ambiguous. The lifestyle approach, which requires applicants to live in very poor living conditions and also demonstrate their hardship to local officials, will be a barrier preventing poor people from being integrated into their communities. This study suggests that the key words and terms in the policy documents need to be clearly explained and similar criteria should also be adopted across different regions. It also proposes that the gap between MLSS eligibility criteria in the policy papers and their actual implementation requires further study in order to understand the impact of special local factors and the quality of life of poor people in China. [ABSTRACT FROM AUTHOR]

Abstract Background The number of children who require palliative care has been estimated to be as high as 21 million globally. Delivering effective children’s palliative care (CPC) services requires accurate population-level information on current and future CPC need, but quantifying need is hampered by challenges in defining the population in need, and by limited available data. The objective of this paper is to summarise how population-level CPC need is defined, and quantified, in the literature. Methods Scoping review performed in line with Joanna Briggs Institute methodology for scoping reviews and PRISMA-ScR guidelines. Six online databases (CINAHL, Cochrane Library, EMBASE, Medline, PsycINFO, and Web of Science), and grey literature, were searched. Inclusion criteria: literature published in English; 2008–2023 (Oct); including children aged 0–19 years; focused on defining and/or quantifying population-level need for palliative care. Results Three thousand five hundred seventy-eight titles and abstracts initially reviewed, of which, 176 full-text studies were assessed for eligibility. Overall, 51 met the inclusion criteria for this scoping review. No universal agreement identified on how CPC need was defined in population-level policy and planning discussions. In practice, four key definitions of CPC need were found to be commonly applied in quantifying population-level need: (1) ACT/RCPCH (Association for Children with Life-Threatening or Terminal Conditions and their Families, and the Royal College of Paediatrics and Child Health) groups; (2) The ‘Directory’ of Life-Limiting Conditions; (3) ‘List of Life-Limiting Conditions’; and (4) ‘Complex Chronic Conditions’. In most cases, variations in data availability drove the methods used to quantify population-level CPC need and only a small proportion of articles incorporated measures of complexity of CPC need. Conclusion Overall, greater consistency in how CPC need is defined for policy and planning at a population-level is important, but with sufficient flexibility to allow for regional variations in epidemiology, demographics, and service availability. Improvements in routine data collection of a wide range of care complexity factors could facilitate estimation of population-level CPC need and ensure greater alignment with how need for CPC is defined at the individual-level in the clinical setting.

The eligibility screening step of a systematic review or systematic map (sometimes referred to as 'study selection', 'evidence selection' or 'inclusion screening') determines the scope of the evidence that may answer the review or map question. Eligibility screening involves the development, testing and application of eligibility criteria (inclusion and exclusion criteria) by an evidence synthesis review team, based on methods pre-specified in the review or map protocol. Some parts of the process require judgement, meaning that consistent and transparent reporting of the eligibility criteria and the process for applying them are essential in order to reduce the risk of introducing errors or bias. The existing Collaboration for Environmental Evidence (CEE) Guidelines for Systematic Reviews in Environmental Management (version 4.2, March 2013) give relatively limited guidance on how to conduct eligibility screening. In this paper we provide more in-depth information on good practice methods for this step of evidence synthesis, based on a critical consideration of existing guidance and current practice. Our aim is to provide recommendations to support those conducting CEE systematic reviews or systematic maps for environmental management questions; however, the methods we describe are generic and should be broadly applicable across a wide range of environmental research topics. [ABSTRACT FROM AUTHOR]

Randomized controlled trials can benefit from proactive assessment of how well their participant selection strategies during the design of eligibility criteria can influence the study generalizability. In this paper, we present a quantitative metric called generalizability index for study traits 2.0 (GIST 2.0) to assess the a priori generalizability (based on population representativeness) of a clinical trial by accounting for the dependencies among multiple eligibility criteria. The metric was evaluated on 16 sepsis trials identified from ClinicalTrials.gov, with their adverse event reports extracted from the trial results sections. The correlation between GIST scores and adverse events was analyzed. We found that the GIST 2.0 score was significantly correlated with total adverse events and serious adverse events (weighted correlation coefficients of 0.825 and 0.709, respectively, with P < 0.01). This study exemplifies the promising use of Big Data in electronic health records and ClinicalTrials.gov for optimizing eligibility criteria design for clinical studies. [ABSTRACT FROM AUTHOR]

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The growing availability of real-world data (RWD) creates opportunities for new evidence generation and improved efficiency across the research enterprise. To varying degrees, sponsors now regularly use RWD to make data-driven decisions about trial feasibility, based on assessment of eligibility criteria for planned clinical trials. Increasingly, RWD are being used to support targeted, timely, and personalized outreach to potential trial participants that may improve the efficiency and effectiveness of the recruitment process. This paper highlights recommendations and resources, including specific case studies, developed by the Clinical Trials Transformation Initiative (CTTI) for applying RWD to planning eligibility criteria and recruiting for clinical trials. Developed through a multi-stakeholder, consensus- and evidence-driven process, these actionable tools support researchers in (1) determining whether RWD are fit for purpose with respect to study planning and recruitment, (2) engaging cross-functional teams in the use of RWD for study planning and recruitment, and (3) understanding patient and site needs to develop successful and patient-centric approaches to RWD-supported recruitment. Future considerations for the use of RWD are explored, including ensuring full patient understanding of data use and developing global datasets. [ABSTRACT FROM AUTHOR]

Background The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [ABSTRACT FROM AUTHOR]

Background Over the past 60 years, the view that 'alcoholism' is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders ( AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. Methods This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. Results Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. Conclusions The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD. [ABSTRACT FROM AUTHOR]

Clinical trials (CTs) often fail due to inadequate patient recruitment. Finding eligible patients involves comparing the patient's information with the CT eligibility criteria. Automated patient matching offers the promise of improving the process, yet the main difficulties of CT retrieval lie in the semantic complexity of matching unstructured patient descriptions with semi-structured, multi-field CT documents and in capturing the meaning of negation coming from the eligibility criteria. This paper tackles the challenges of CT retrieval by presenting an approach that addresses the patient-to-trials paradigm. Our approach involves two key components in a pipeline-based model: (i) a data enrichment technique for enhancing both queries and documents during the first retrieval stage, and (ii) a novel re-ranking schema that uses a Transformer network in a setup adapted to this task by leveraging the structure of the CT documents. We use named entity recognition and negation detection in both patient description and the eligibility section of CTs. We further classify patient descriptions and CT eligibility criteria into current, past, and family medical conditions. This extracted information is used to boost the importance of disease and drug mentions in both query and index for lexical retrieval. Furthermore, we propose a two-step training schema for the Transformer network used to re-rank the results from the lexical retrieval. The first step focuses on matching patient information with the descriptive sections of trials, while the second step aims to determine eligibility by matching patient information with the criteria section. Our findings indicate that the inclusion criteria section of the CT has a great influence on the relevance score in lexical models, and that the enrichment techniques for queries and documents improve the retrieval of relevant trials. The re-ranking strategy, based on our training schema, consistently enhances CT retrieval and shows improved performance by 15% in terms of precision at retrieving eligible trials. The results of our experiments suggest the benefit of making use of extracted entities. Moreover, our proposed re-ranking schema shows promising effectiveness compared to larger neural models, even with limited training data. These findings offer valuable insights for improving methods for retrieval of clinical documents. [Display omitted] • We conduct several experiments for the patient-to-trial matching retrieval problem. • Inclusion criteria section has the biggest influence on the score in lexical models. • Query and document enrichment techniques improve retrieval of relevant trials. • Age and gender-based filtering helped remove 26% ineligible trials. • Novel training strategy for re-ranking further increases retrieval effectiveness. [ABSTRACT FROM AUTHOR]

Background: Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status. Methods: Data on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression. Results: Our analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older. Conclusions: Many recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice. [ABSTRACT FROM AUTHOR]

The paper presents a history of development of scholarships for young talents in Slovenia. Through recent years the eligibility criteria to obtain the scholarship has changed as policy and certain characteristics have been reformed. The paper argues about stricter criteria that were implemented in recently reformed Scholarship policy act. The discussion includes a proposal for necessary improvements within the system of Zois scholarships. The described changes would assign the Zois scholarship a greater role in promoting the students’ career development during and after their educational process.

Adjustment for prognostic covariates increases the statistical power of randomized trials. The factors influencing the increase of power are well-known for trials with continuous outcomes. Here, we study which factors influence power and sample size requirements in time-to-event trials. We consider both parametric simulations and simulations derived from the Cancer Genome Atlas (TCGA) cohort of hepatocellular carcinoma (HCC) patients to assess how sample size requirements are reduced with covariate adjustment. Simulations demonstrate that the benefit of covariate adjustment increases with the prognostic performance of the adjustment covariate (C-index) and with the cumulative incidence of the event in the trial. For a covariate that has an intermediate prognostic performance (C-index=0.65), the reduction of sample size varies from 3.1% when cumulative incidence is of 10% to 29.1% when the cumulative incidence is of 90%. Broadening eligibility criteria usually reduces statistical power while our simulations show that it can be maintained with adequate covariate adjustment. In a simulation of adjuvant trials in HCC, we find that the number of patients screened for eligibility can be divided by 2.4 when broadening eligibility criteria. Last, we find that the Cox-Snell R C S 2 is a conservative estimation of the reduction in sample size requirements provided by covariate adjustment. Overall, more systematic adjustment for prognostic covariates leads to more efficient and inclusive clinical trials especially when cumulative incidence is large as in metastatic and advanced cancers. Code and results are available at https://github.com/owkin/CovadjustSim. [ABSTRACT FROM AUTHOR]

Day reporting centers (DRCs) vary considerably in how participant eligibility is determined and to date, there is little to no knowledge whether criteria for DRC eligibly are appropriately applied in program entrance. This study examines a statewide sample of individuals in community supervision settings and compares DRC eligibility criteria between DRC and non-DRC participants to examine differences between DRC participants and non-participants. Using a propensity score matched sample of 1,554 participants, study findings suggest that DRC participants show higher risk, need, and responsivity factors, consistent with the DRC programing model. These results suggest many individuals appear to be appropriately matched to DRCs, which may in turn, may influence their likelihood of program success, among other factors. [ABSTRACT FROM AUTHOR]

We examined eligibility criteria from recent oncology clinical trials to see whether real-world data (RWD) from electronic health records (EHRs) could be used to create external control groups for clinical trials. Trials were identified from the Aggregate Analysis of ClinicalTrials.gov database; the selected trials were for oncology drugs approved by the FDA in 2020. Verbatim text from trial inclusion and exclusion criteria was qualitatively assessed by an expert panel to determine if criteria could be ascertained from structured and unstructured EHR data. Identified criteria were categorized (cancer-related, comorbidity-related, demographic, functional status, and trial operations) and subcategorized. Among 53 identified trials, 20 met the requirements for study inclusion, which included 463 eligibility criteria. Percentages of criteria by category were as follows: cancer-related factors (46%), comorbidities (20%), functional status (18%), trial operations (14%), and demographics (2%). For 18 of the 20 trials, 80% of the eligibility criteria could be ascertained with RWD; for 4 of the 20, it was 100%. When trial operation-specific criteria were excluded, all 20 met the 100% threshold. Our study indicates that both structured and unstructured data from community-based oncology-specific EHRs can be used for determining patient eligibility for external control arms for clinical trials. [ABSTRACT FROM AUTHOR]

The voluntary, unpaid, altruistic blood donor is a cornerstone of current transfusion medicine. The complexity of medical and ethical issues related to blood donation and hemochromatosis has led to a large number of studies related to the safety of the hemochromatosis donor and the quality of the blood components produced from these donations. The issue of accepting persons with HC as blood donors is diverting, both in Europe and worldwide and without joint guidelines. A questionnaire-based study was performed and mailed to all 25 blood bank leaders in Norway. Descriptive analysis was used to evaluate the data. Eight of 22 blood banks strictly followed national guidelines concerning persons with hemochromatosis. Other blood banks make local adjustments. 16 of 22 responding blood banks accept hemochromatosis donors and five do not, and one answered partly yes. The reasons the blood bank leaders supported the acceptance of hemochromatosis donors differ. Based on published papers and the present questionnaire, we believe that a clear definition of the “hemochromatosis donor” and guidelines with more detailed information on an acceptable donation regime would be important to overcome the weak points in blood donor eligibility criteria. [ABSTRACT FROM AUTHOR]

Background: Clinical trial protocols are the foundation for advancing medical sciences, however, the extraction of accurate and meaningful information from the original clinical trials is very challenging due to the complex and unstructured texts of such documents. Named entity recognition (NER) is a fundamental and necessary step to process and standardize the unstructured text in clinical trials using Natural Language Processing (NLP) techniques.Methods: In this study we fine-tuned pre-trained language models to support the NER task on clinical trial eligibility criteria. We systematically investigated four pre-trained contextual embedding models for the biomedical domain (i.e., BioBERT, BlueBERT, PubMedBERT, and SciBERT) and two models for the open domains (BERT and SpanBERT), for NER tasks using three existing clinical trial eligibility criteria corpora. In addition, we also investigated the feasibility of data augmentation approaches and evaluated their performance.Results: Our evaluation results using tenfold cross-validation show that domain-specific transformer models achieved better performance than the general transformer models, with the best performance obtained by the PubMedBERT model (F1-scores of 0.715, 0.836, and 0.622 for the three corpora respectively). The data augmentation results show that it is feasible to leverage additional corpora to improve NER performance.Conclusions: Findings from this study not only demonstrate the importance of contextual embeddings trained from domain-specific corpora, but also shed lights on the benefits of leveraging multiple data sources for the challenging NER task in clinical trial eligibility criteria text. [ABSTRACT FROM AUTHOR]

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes – the science of clinical research – are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. [ABSTRACT FROM AUTHOR]

Unemployment insurance recipients in the Netherlands were for many years exempted from the requirement to actively search for a job after they reached the age of 57.5. We study how this exemption affected the job finding rates of the recipients involved. Our results indicate that the job finding rate starts to fall just prior to the removal of the search requirement at age 57.5. In addition we find a large negative effect on job finding rates of the actual removal of the search requirement at age 57.5. Apparently, even for persons with seemingly poor job prospects search requirements have a positive effect on finding rates. [ABSTRACT FROM AUTHOR]

This article is a case study of one of the few sports, rugby, that does not link national representation exclusively to citizenship. It discusses who may represent a country in major events and under which conditions. It analyses the consequences of the rules on different stakeholders; and discusses why the residency rule in particular is subject to much controversy. The author has conducted case studies of the 2019 rugby union and 2017 rugby league men’s World Cups. Academic literature, international news-papers, and rugby-specific websites were reviewed. Other than secondary sources, the researcher also collected primary data through interviews. The interviewees included representatives of Rugby League International Federation and World Rugby. This research reveals that national representation without citizenship is widespread in both codes of rugby. It has also shown that the effects of the eligibility criteria go beyond simplistic rich/poor and center/periphery models. This article argues that the rational for the eligibility criteria is the limited global spread of rugby league and rugby union. Without those lenient rules it would be difficult to organize international competitions.

Introduction: Pivotal Randomized Controlled Trials (RCTs) constitute scientific evidence in support of therapeutic choices when a drug is authorized in the market. In RCTs, patients are selected in a rigorous manner, in order to avoid bias that may influence efficacy assessments. Therefore, patients who take the drug in Real Life Studies (RLSs) are not the same as those participating in RCTs, which, in turn, leads to low data transferability from RCTs to RLS. The objective of this study was to evaluate the differences between RCTs and RLS, in terms of patient baseline characteristics. Materials and Methods: Our study includes all oral target therapies for RCC (Renal Cell Carcinoma) marketed in Europe before March 31, 2019. For each treatment, we considered both RCTs and RLSs, the former gathered from Summary of Product Characteristics published on the European Medicine Agency (EMA) website, and the latter yielded by our search in relevant literature. For each drug considered, we then compared the baseline characteristics of patients included in the RCT samples with those of the samples included in the RLSs using the Chi-squared and Mann-Whitney tests. Results: We considered six medicines, for a total of 9 pivotal RCTs and 31 RLSs. RCTs reported the same type of patient baseline characteristics, whereas RLSs are more varied in reporting. Some patient baseline characteristics (metastases, previous treatments, etc.) were significantly different between RCTs and RLs. Other characteristics, such as ECOG Performance Status, brain metastases, and comorbidities, liver and kidney failure, are comprised in exclusion criteria of RCTs, though are included in RLS. Discussion and Conclusion: While evaluating equal treatments for the same indications, RCTs and RLSs do not always assess patients with the same characteristics. It would be necessary to produce evidence from RLSs so as to have an idea of treatment effectiveness in patients groups that are not eligible or underrepresented in RCTs. [ABSTRACT FROM AUTHOR]

Background: The balance between ensuring blood donor and recipient safety while maintaining a sufficient blood supply can be affected by excessive deferral of blood donors. In 2018, a biannual regulatory review of donor eligibility criteria provided the South African National Blood Service (SANBS) the opportunity to review the existing criteria. Changes to these criteria were implemented in April 2019 after an extensive review. Study Design and Methods: We conducted a cross‐sectional study of SANBS whole‐blood donor presentations to determine the impact of the changed donor eligibility criteria on deferrals and blood safety. We compared donor presentations, deferrals, and HIV‐positive cases for the 12‐month period (April 2019–March 2020) after the implementation of the updated donor eligibility criteria to those of the previous year. Results: Of the 2,112,917 donor presentations, 51.1% (1079506) occurred in the post‐implementation study period. Overall, deferrals decreased from 18.6% to 14.5%, whereas HIV‐positive donations increased by 0.03%. A multivariable logistic regression analysis adjusted for sex, age, geographical location, donor, and clinic type showed significantly lower odds of deferral (OR 0.70; 95% CI: 0.69–0.70) and greater odds of HIV‐positive cases in the study period than those in the control period (OR 1.17; 95% CI: 1.10–1.25). Conclusion: We confirmed that the change in donor eligibility criteria was associated with a decrease in deferrals and an increase in the country's blood supply. The impact of the increased number of HIV‐positive donations on blood safety in a country performing individual donation nucleic acid amplification testing requires further investigation. [ABSTRACT FROM AUTHOR]

Background: Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants' safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters' experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed. Methods: Our survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes. Results: A total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process. Conclusions: Our survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria. [ABSTRACT FROM AUTHOR]

Juvenile drug treatment courts (JDTCs), in large part, are a product of the therapeutic jurisprudence movement. When they were established in 1993 in the U.S., JDTCs were initially modeled after adult drug treatment courts but insufficiently addressed unique characteristics of adolescence. In 2003, recommended practices, known as the 16 Strategies, for JDTCs working with adolescent offenders with substance use disorders were introduced to the field by the National Drug Court Institute (NDCI) and the National Council of Juvenile and Family Court Judges (NCJFCJ). Recently, the Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the American Institute of Research (AIR), proposed a set of evidence‐based, recommended practices outlined in the Juvenile Drug Treatment Court Guidelines (JDTC Guideline). However, little research examines the effectiveness of training and technical assistance on recommended, evidence‐based practices for JDTC teams. The current study uses a pre/post‐training survey design to examine perceived and actual knowledge gain of JDTC practitioners who receive targeted training and technical assistance on recommended practices for JDTCs. The data demonstrate significantly higher perceived knowledge gain, post‐training, on the topics of recommended practice (as outlined in the 16 Strategies and JDTC Guidelines). Implications are discussed. Key Points for the Family Court Community: Juvenile Drug Treatment Courts (JDTCs) can receive onsite training and technical assistance (TTA)TTA can increase JDTC team members' perceived knowledge in various domains such as adolescent development, JDTC best practices, and role discriminationTTA can also increase awareness and knowledge of local JDTC eligibility criteriaThere is need for JDTCs to constantly improve and update practices to comport with current best practices, and TTA might be a way for courts to accomplish this [ABSTRACT FROM AUTHOR]

Summary: Eligibility criteria for randomised control trials (RCT) in diffuse large B‐cell lymphoma (DLBCL) may be becoming increasingly strict. In this analysis, 42 first‐line phase III RCTs enrolling DLBCL patients since 1990 were identified from PubMed and clinicaltrials.gov. Changes in 31 individual eligibility criteria were assessed using three pre‐defined eras [(1) 1993–2005; (2) 2006–2013; and (3) 2014–2020]. The presence of 15/31 criteria increased significantly over time, and the total number of criteria per study also increased over time [median Era 1: 14·5, interquartile range (IQR) 12·6–16·4; Era 2: 21, 18·8–23·3; Era 3: 23, 21–25; P < 0·001]. When each trial's eligibility criteria were applied to 215 consecutive patients from an institutional database treated between 2010 and 2020, a median of 57% (IQR 47–70) of patients were hypothetically eligible for trial enrolment. The median percentage of patients eligible was 68% (56–91), 54% (37–81) and 47% (38–82) for Era 1, 2 and 3 respectively (P = 0·004). Phase III front‐line DLBCL trial criteria have become increasingly restrictive over the last three decades, resulting in a diminishing proportion of trial‐eligible patients, with less than 50% of our patients eligible for modern‐era studies. This potentially impacts generalisability of recent trial results and will likely limit recruitment to ongoing studies. [ABSTRACT FROM AUTHOR]

Candidate‐selection methods (CSM) crucially affect the behavior of Members of Parliament (MPs). Extant research investigates the consequentiality of the selectorate, but is neglecting the candidacy dimension of CSM. But what are the behavioral implications of minimal candidacy‐eligibility criteria (CEC)? I theorize that parties adopt closed CEC in safe districts to ensure nominating loyalist candidates, while they use open CEC in contested districts to attract entrepreneur candidates able to woo decisive swing voters. Using survey and observational data from Japan, where parties have concurrently been nominating candidates through open and more closed CEC, I show that entrepreneur candidates are more responsive to their districts but less active in the legislature, measured by different types of activities. These findings corroborate my expectations that entrepreneur candidates lack political experience and are sidelined by their more traditional colleagues. Moreover, the results broaden our understanding of how CSM affect MPs' behavior. [ABSTRACT FROM AUTHOR]

Abstract Background The definition of the eligibility criteria of newborn, infant, child, or adolescent patients for palliative care (PC) is complicated by the fact that these patients generally present with very specific case histories that make it inadvisable to directly adopt existing PC protocols devised for adult patients. Thus, the goal of this paper is to define a standard set of criteria for establishing pediatric palliative care (PPC) eligibility. Methods The method adopted was that of the consensus conference. According to the guidelines issued by the Higher Institute of Health, the Board of the Italian Society for Palliative Care (i.e. steering committee) appointed a multidisciplinary group of eight health care professionals (i.e. doctors, nurses and psychologists) who worked from May 2014 to February 2016 to reach a consensus over PPC eligibility. This panel of relevant experts redacted a report summarizing all available scientific information concerning PPC, which was then submitted to the attention of a multidisciplinary jury composed of specialists and non-specialists of the field. The document thus produced was subsequently reviewed by an extended team of experts. Results The consensus conference drafted a final document determining the guidelines for PPC eligibility of newborns, infants, children, and adolescents suffering from either oncological or non-oncological diseases. Conclusions This report provides health care providers with practical guidelines on how to define the eligibility of pediatric patients for PPC. Given the current situation in Italy, these guidelines will be instrumental in assisting the implementation of adequate generalist and specialist PPC services as well as in helping policymakers draft and implement national legislation pertaining to PPC.

State financial aid grant programs are commonly categorized as either need-based, merit-based, or both, but their initial eligibility requirements include many more factors than just financial need and academic merit. A categorization of programs that accounts for all requirements would facilitate a more nuanced and precise understanding of state grant programs. We used latent class analysis to organize 354 grant programs into a five-category typology to better understand the variations and patterns in programs. Need and merit proved important in the typology, but two of the new categories of programs were defined by other eligibility requirements. Implications for future research and policymaking are discussed. [ABSTRACT FROM AUTHOR]

Young people transitioning from out-of-home care (generally called care leavers) are recognised globally as a vulnerable group. In the last eighteen months, four Australian jurisdictions have extended state care till twenty-one years in an attempt to advance the life opportunities of this cohort. These initiatives are strongly influenced by extended care programmes in the USA and England, which have reported improved outcomes for care leavers. This article interrogates formal public evaluations of these extended care programmes with a particular focus on their eligibility criteria that have determined which groups of care leavers are included or alternatively excluded and the identified strengths and limitations of the programmes. Additionally, we consider cross-cultural differences in leaving care populations and variations within the broader social policy context of these jurisdictions, which may also impact on the effectiveness of policy transfer. Some conclusions are drawn about key factors that may enhance the success of extended care programmes. [ABSTRACT FROM AUTHOR]

Extant research suggests that candidate selection methods can be consequential for party unity in legislative voting. Yet thus far, only variations in the selectorate and the degree of centralization have been examined. This article argues that Candidacy Eligibility Criteria (CEC), too, have implications for party unity. I theorize that with stricter formal requirements, parties avoid adverse selection and ensure the nomination of committed candidates. By using roll-call vote data from 16 industrial democracies, candidate surveys and an original data set consisting of nearly 500 historical party constitutions, I show that parties demanding prior membership and nudging aspirants to maintain networks within the party tend to be more unified in parliamentary voting. Moreover, their candidates, too, express greater loyalty when compared with parties without formal CEC. Thus, this article contributes to the literatures on party unity and on candidate selection by showing how certain party rules, hitherto neglected, affect party unity. [ABSTRACT FROM AUTHOR]

Introduction: Following the US Food and Drug Administration (FDA) guidance on the evaluation of novel agents for the treatment of type 2 diabetes mellitus (T2DM), a number of cardiovascular outcomes safety trials (CVOTs) on sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been conducted. These trials show similarities in study design and definition of primary endpoints, but differ in their eligibility criteria. The aim of the present study was to investigate the generalizability of CVOTs on SGLT2i to Italian adults with T2DM; we estimated the proportions of this patient population who would be eligible for enrollment in EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin), DECLARE-TIMI 58 (dapagliflozin), and VERTIS-CV (ertugliflozin) studies.Methods: This observational, cross-sectional study was conducted in 222 Italian diabetes clinics. Data on 455,662 adult patients with T2DM seen during 2016 were analyzed against the published patient eligibility criteria for the four CVOTs. The current use of SGLT2i in potentially eligible patients was assessed.Results: Among the population identified, the proportion of patients meeting major eligibility criteria was 11.7% for EMPA-REG OUTCOME, 29.4% for CANVAS, 55.9% for DECLARE-TIMI 58, and 12.8% for VERTIS-CV. Of the patients eligible for these CVOTs, only a minority (range 4.4-6.8%) was actually prescribed an SGLT2i. Compared with patients in the CVOTs, eligible patients in the real world showed older age and longer diabetes duration, lower BMI and HbA1c levels, lower prevalence of established cardiovascular and cerebrovascular disease, and higher rates of microvascular complications and peripheral arterial disease.Conclusion: The percentage of patients potentially eligible for treatment with SGLT2i varies as a reflection of different eligibility criteria applied in the trials. A large number of patients that could benefit from SGLT2i in terms of not only cardiovascular protection but also renal protection do not receive the treatment.Funding: AstraZeneca. [ABSTRACT FROM AUTHOR]