Prerequisites to support high-quality clinical trials in children and young people

2020 ◽  
pp. archdischild-2019-318677
Author(s):  
Steven Hirschfeld ◽  
Florian B Lagler ◽  
Jenny M Kindblom
Keyword(s):  
Clinical Trials ◽  
Healthcare Delivery ◽  
Paediatric Population ◽  
Ecosystem Functions ◽  
Healthcare Delivery System ◽  
High Quality ◽  
Children And Young People ◽  
The Right ◽  
Support Decision Making

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population. High-quality clinical trials involving children of all ages can generate data that will ultimately close the knowledge gaps and support decision making.For clinical trials that enrol children, the needs are specialised and often resource intensive. Prerequisites for successful paediatric clinical trials are personnel with training in both paediatrics and neonatology and expertise in clinical trials in these populations. Moreover, national and international networks for efficient collaboration, dissemination of information, and sharing of resources and expertise are also needed, together with competent, efficient and high-quality local infrastructure with effective processes. Monitoring and oversight bodies with the relevant competence, including expertise in paediatrics, is also an important prerequisite for paediatric clinical trials. Compromise in any of these components will compromise the downstream results.This paper discusses the structures and competences needed in order to perform effective, high-quality paediatric clinical trials with the ultimate goal of better medicines and treatments for children. We propose a model of examining the process as a series of components that each has to be optimised, then all the components are actively optimised to function together as an ecosystem, and the resulting ecosystem functions well with the general research system and the healthcare delivery system.

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

scholarly journals Epidemiological and clinical aspects of immunoglobulin A vasculitis in childhood: a retrospective cohort study

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Breda Luciana ◽  
Carbone Ilaria ◽  
Casciato Isabella ◽  
Cristina Gentile ◽  
Eleonora Agata Grasso ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Renal Involvement ◽  
Healthcare Delivery ◽  
Immunoglobulin A ◽  
Retrospective Chart Review ◽  
Paediatric Population ◽  
Clinical Aspects ◽  
Healthcare Delivery System ◽  
Laboratory Findings ◽  
Immunoglobulin A Vasculitis

Abstract Background A retrospective study was conducted in order to investigate and describe the characteristics of Immunoglobulin A vasculitis (IgAV), previously known as Henoch-Schӧnlein purpura, in the paediatric population of a community-based healthcare delivery system in the Italian region of Abruzzo. Methods This is a population-based retrospective chart review of the diagnosis of IgAV in children ages 0 to 18, admitted to the Department of Paediatrics of Chieti and Pescara between 1 January 2000 and 31 December 2016. All children enrolled presented with clinical symptoms and laboratory findings and met the EULAR/PRINTO/PRES 2008 criteria. Results Two-hundred-eight children met the criteria for IgAV, with the highest incidence reported among children below 7-years of age. A correlation with recent infections was found in 64% of the cohort; the onset was more frequently during the winter and fall. Purpura had a diffuse distribution in the majority of patients; joint impairment was the second most frequent symptom (43%), whereas the gastrointestinal tract was involved in 28% of patients. Conclusions Hereby, we confirm the relative benignity of IgAV in a cohort of Italian children; with regards to renal involvement, we report a better outcome compared to other studies. However, despite the low rate of renal disease, we observed a wide use of corticosteroids, especially for the treatment of persistent purpura.

scholarly journals The design and research of the shared kitchen system in the hospital

2018 ◽  
Vol 176 ◽  
pp. 01011
Author(s):  
YE Xin ◽  
JI Qian
Keyword(s):  
Quality Of Life ◽  
Social Interaction ◽  
High Efficiency ◽  
Low Cost ◽  
Space System ◽  
High Quality ◽  
Economy Model ◽  
New Directions ◽  
The Right

The shared economy has been developing rapidly with low cost, low consumption and high environmental efficiency features under the background of internet waves. The shared economy model has emerged in housing, catering, and travel. As people look forward to high quality of life and their social interaction need, the shared kitchen platform arises at the right moment. This paper takes the shared kitchen as an example, focusing on the patients and their caregivers, the existing shared kitchens and its service platform as well as the space system design and human-computer interaction of the shared kitchen have been investigated and analysized. Taking the "high efficiency, the intelligence and the humanization" as the design principles, we are committed to exploring new directions for modular kitchen design under the background of shared economy.

scholarly journals HARMONIZATION OF CRIMINAL PROCEDURE AS A MEANS OF ENSURING THEIR UNIFORM APPLICATION

2021 ◽  
Vol 31 (3) ◽  
pp. 509-514
Author(s):  
D.V. Tat'yanin
Keyword(s):  
Criminal Procedure ◽  
Criminal Case ◽  
Criminal Proceedings ◽  
High Quality ◽  
Red Tape ◽  
Judicial Proceedings ◽  
The Law ◽  
The Right ◽  
Different Content

The law of criminal procedure contains a number of rules with different content, which raises a number of questions in their interpretation and application. Decisions made using rules with different content lead to their appeal, often to annulment, which does not ensure the achievement of the appointment of criminal proceedings, but leads to unjustified red tape in criminal proceedings and the delay in making final decisions on them. The need to harmonize criminal procedure rules is related to ensuring high-quality and effective criminal proceedings, ensuring the protection of the rights of participants in criminal proceedings, the quality of the evidence process, both in pre-trial and judicial proceedings. The article addresses the problems of unification of criminal procedure rules containing such concepts as an investigator and urgent investigative actions. It is proposed to eliminate the contradictions in them in order to ensure their uniform application. The introduction of a single concept of investigator and refusal to use the profession of "forensic investigator" in this concept is justified, it is proposed to expand the number of participants who have the right to carry out urgent investigative actions, as well as to assign to them investigative actions carried out at the stage of initiating a criminal case.

scholarly journals Sustainability Symbol of Justice

2017 ◽  
Vol 3 (1) ◽  
pp. 82
Author(s):  
Noor Farihah Mohd Noor
Keyword(s):  
Quality Of Life ◽  
Judicial Review ◽  
High Quality ◽  
Public Power ◽  
Administrative Action ◽  
Judicial Scrutiny ◽  
The Right

Quality of life has very much to do with being sustainable. In a country where development and money is the means of progressing making profits, are unavoidable. But does the quest for progress hamper sustainability? Sustainability is important because it reflects a balance between freedom and power, independence and authority, rich and poor, justices and oppression. We have seen much oppression that emerges from exercising public power. Despite the formation of institution like integrity bodies, separate organizations to combat corruptions, tribunals and the like, yet public oppression never subside. Rudeness, unwillingness to treat the complainant as a person with rights; refusal to answer reasonable question; neglecting to inform complainant on request of her entitlement; knowingly giving misleading or inadequate advice; ignoring valid advice or overruling consideration which would produce an uncomfortable result for the overuler; offering no redress or manifestly disproportionate redress; showing bias on colour or whatever ground; refusing to inform adequately the right of appeal ; failure to mitigate the effect of rigid adherence to which it can produce manifestly inadequate treatment are all forms of malfeasance of the modern days. The focus of this paper thus is to look at the possible ways of combatting bad administration via judicial review of administrative action. What’s interesting is the ability of the court to tease out the complicated issues so that justice could be delivered. Justice is far-reaching if it can be exercised beyond merely the judicial scrutiny. Being able to address the lack of justice is in fact a reflection of sustainability and high quality of life.

scholarly journals Stakeholders' Perception of the Introduction of Specialized Hospitals for Urologic Diseases: Qualitative Study

2021 ◽  
Vol 27 (2) ◽  
pp. 2-17
Author(s):  
Hye-Ran Jeong ◽  
Jee-Hee Pyo ◽  
Eun-Young Choi ◽  
Ju-Young Kim ◽  
Young-Kwon Park ◽  
...  
Keyword(s):  
Group Discussion ◽  
Healthcare Delivery ◽  
Government Support ◽  
Healthcare Delivery System ◽  
Hospital System ◽  
Urologic Diseases ◽  
Specialized Hospital ◽  
Depth Interview ◽  
Hospital Systems

Purpose: The purpose of this study is to seek in-depth perspectives of stakeholders on the necessity and specific criteria for designating a specialized hospital for urologic diseases.Methods: Eight participants experts in urology medicine and specialized hospital system were divided into four groups. Following the semi-structured guidelines, an in-depth interview was conducted twice and a focus group discussion was conducted three times. All the interviews were transcribed verbatim and analyzed.Results: The majority of participants predicted that there would be demand for specialized hospitals for urologic diseases. The criteria of designating a specialized hospital, such as the number of hospital beds and quality of health care, have to be modified in consideration of the specificity of urology. The introduction of a specialized hospital would improve the healthcare delivery system, positively affecting hospitals and patients. Furthermore, government support is essential for the maintenance of specialized hospital systems as urology hospitals experience difficulties in generating profits.Conclusion: This study is expected to be used as base data for introducing and operating a specialized hospital for urologic diseases. In addition, it is expected that the methodology and results of this study would encourage follow-up studies on specialized hospitals and provide guidelines to evaluate the effectiveness of such hospitals in other medical fields.

Medical Education in the 21st Century

2011 ◽  
pp. 528-535
Author(s):  
Stefane M. Kabene ◽  
Jatinder Takhar ◽  
Raymond Leduc ◽  
Rick Burjaw
Keyword(s):  
Medical Education ◽  
Quality Of Care ◽  
Patient Outcomes ◽  
21St Century ◽  
Healthcare Professionals ◽  
New Technologies ◽  
Healthcare Delivery ◽  
The Right

As with many disciplines, the fields of healthcare in general and medicine, in particular, have made vast strides in improving patient outcomes and healthcare delivery. But, have healthcare professionals and medical academia been able to maximize the utilization of new technologies to improve the delivery of the right knowledge, to the right people, at the right time across geographical boundaries? In order to provide the best quality of care, regardless of patient or provider location, specific issues must be addressed.

Medical Education in the 21st Century

2005 ◽  
pp. 488-493
Author(s):  
Stefane M. Kaben ◽  
Jatinder Takhar ◽  
Raymond Leduc ◽  
Rick Burjaw
Keyword(s):  
Medical Education ◽  
Quality Of Care ◽  
Patient Outcomes ◽  
21St Century ◽  
Healthcare Professionals ◽  
New Technologies ◽  
Healthcare Delivery ◽  
The Right

As with many disciplines, the fields of healthcare in general and medicine, in particular, have made vast strides in improving patient outcomes and healthcare delivery. But, have healthcare professionals and medical academia been able to maximize the utilization of new technologies to improve the delivery of the right knowledge, to the right people, at the right time across geographical boundaries? In order to provide the best quality of care, regardless of patient or provider location, specific issues must be addressed.

scholarly journals A New Software Development Methodology for Clinical Trial Systems

2013 ◽  
Vol 2013 ◽  
pp. 1-13
Author(s):  
Li-Min Liu
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Software Development ◽  
Quality Of Data ◽  
High Quality ◽  
Development Methodology ◽  
Software Development Methodology ◽  
The Government ◽  
New Software Development

Clinical trials are crucial to modern healthcare industries, and information technologies have been employed to improve the quality of data collected in trials and reduce the overall cost of data processing. While developing software for clinical trials, one needs to take into account the similar patterns shared by all clinical trial software. Such patterns exist because of the unique properties of clinical trials and the rigorous regulations imposed by the government for the reasons of subject safety. Among the existing software development methodologies, none, unfortunately, was built specifically upon these properties and patterns and therefore works sufficiently well. In this paper, the process of clinical trials is reviewed, and the unique properties of clinical trial system development are explained thoroughly. Based on the properties, a new software development methodology is then proposed specifically for developing electronic clinical trial systems. A case study shows that, by adopting the proposed methodology, high-quality software products can be delivered on schedule within budget. With such high-quality software, data collection, management, and analysis can be more efficient, accurate, and inexpensive, which in turn will improve the overall quality of clinical trials.

scholarly journals Edukacyjne aspekty działalności agroturystycznej w Polsce

1970 ◽  
Vol 14 (2) ◽  
Author(s):  
Agnieszka Wartecka-Ważyńska
Keyword(s):  
Young People ◽  
Rural Areas ◽  
Empirical Studies ◽  
Educational Services ◽  
Quality Of Services ◽  
Cultural Education ◽  
High Quality ◽  
Children And Young People ◽  
Professional Employees

The paper addresses the problems of education, including environmental and cultural education, of children and young people offered by agritourism farms. The study also indicates the need for school education and extracurricular education of families involved in agritourism. Professional employees in agritourism represent precious human capital for rural areas and guarantee high quality of services, e.g. educational services for tourists, including children and young people. The particular focus was on education in the field of ecology and rural cultural heritage. Institutions in one way or another involved in education in agritourism were also discussed. The paper was written based on literature and results of empirical studies.

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