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Key components and IT assistance of participant management in clinical research: a scoping review.

ABSTRACT: Objectives:Managing participants and their data are fundamental for the success of a clinical trial. Our review identifies and describes processes that deal with management of trial participants and highlights information technology (IT) assistance for clinical research in the context of participant management. Methods:A scoping literature review design, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, was used to identify literature on trial participant-related proceedings, work procedures, or workflows, and assisting electronic systems. Results:The literature search identified 1329 articles of which 111 were included for analysis. Participant-related procedures were categorized into 4 major trial processes: recruitment, obtaining informed consent, managing identities, and managing administrative data. Our results demonstrated that management of trial participants is considered in nearly every step of clinical trials, and that IT was successfully introduced to all participant-related areas of a clinical trial to facilitate processes. Discussion:There is no precise definition of participant management, so a broad search strategy was necessary, resulting in a high number of articles that had to be excluded. Nevertheless, this review provides a comprehensive overview of participant management-related components, which was lacking so far. The review contributes to a better understanding of how computer-assisted management of participants in clinical trials is possible.

SUBMITTER: Pung J

PROVIDER: S-EPMC7660951 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Key components and IT assistance of participant management in clinical research: a scoping review.

Pung Johannes J Rienhoff Otto O

JAMIA open 20201014 3

<h4>Objectives</h4>Managing participants and their data are fundamental for the success of a clinical trial. Our review identifies and describes processes that deal with management of trial participants and highlights information technology (IT) assistance for clinical research in the context of participant management.<h4>Methods</h4>A scoping literature review design, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, was used to identify literature on tr ...[more]

PMID: 33215078

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Project description:BackgroundReports suggest that children with mobility impairment represent a significant proportion of the population living with a disability. Footwear is considered to be the key extrinsic factor affecting children's gait and footwear modifications have been historically postulated to assist with locomotory difficulty. Although therapeutic footwear has been considered within the literature, there is a lack of consistency on terminology and paucity on the overall understanding. A scoping review was performed to chart the key concepts in children's footwear and to establish the range of studies that considered therapeutic footwear.MethodsA systematic search of MEDLINE, CINAHL, PubMed, SPORTdiscus, and Scopus electronic databases was performed using MeSH headings and free text terms in relation to children's footwear. All studies that used footwear as an intervention in children aged 9 months to 18 years with the outcome measures including design, fit, and the effects on development and health were included. Studies were charted by textual narrative synthesis into research groupings dependent on the topics discussed and the methods used in the studies.ResultsThe search yielded a total of 5006 articles with 287 of these articles meeting the inclusion criteria. Two overarching areas of research were identified; articles that discussed footwear design and those that discussed the effects of footwear. Eight further general groupings were charted and apportioned between the overarching areas and therapeutic footwear was charted into three subgroupings (corrective, accommodative and functional).ConclusionChildren's footwear has become an increasing area of research in the past decade with a shift towards more empirical research, with most of the included articles examining biomechanical and anthropometric aspects. However, children's therapeutic footwear has not shared the same recent impetus with no focused review and limited research exploring its effects. Empirical research in this area is limited and there is ambiguity in the terminology used to describe therapeutic footwear. Based on the findings of this review the authors suggest the term children's therapeutic footwear be used as the standard definition for footwear that is designed specifically with the purpose to support or alleviate mobility impairment in childhood; with subgroupings of corrective, accommodative and functional dependent on the intended therapeutic role.

Project description:The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies.We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants.Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt.A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.

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Project description:Background: Research on disparities in traumatic injury has not been well characterized, limiting understanding of gaps in research and development of successful interventions. We conducted a scoping review to identify and synthesize research on disparities in intentional and unintentional traumatic injuries. Methods: The review was guided by PRISMA Extension for Scoping Reviews. PubMed, PsycINFO, Web of Science, and CINAHL and systematic reviews from 2007 to 2017 were searched. Eligible articles were peer reviewed; conducted in the United States; and reported on clearly defined physical trauma and disparity, defined by Cochrane PROGRESS-Plus criteria. One reviewer assessed article titles and a second reviewer validated the inclusion with a random sample. Abstract and full-text review by two reviewers determined final inclusion. Results: Of 7382 unique articles screened, 653 articles were included; inter-rater agreement was high (K=0.995). Studies reported on disparities in the acute hospital setting (104) or postacute/rehabilitation (86), with fewer focused on prevention (57) and policy development (6). Research methods used were quantitative (593) with 25 intervention studies, qualitative (45), qualitative/quantitative (7), and community-based participatory research (8). Age ranges of included studies were all ages (124), adults (318), pediatric/youth/adolescents (172), and older adults (40). Racial disparities were most commonly measured (439 studies); 38 created a white/nonwhite binary. Other commonly measured disparities were place of residence (122), insurance (111 studies), gender (89), age (75), and socioeconomic status measures (61). Disparities were noted in all of the categories. Studies commonly aggregated all types of traumatic injuries (129) or all types of violence (105). Conclusions: The extant injury literature lacks research on prevention and policy to address disparities. Many studies aggregated types of trauma and patient groups, preventing an understanding of distinctions between groups and potential interventions. Intervention and community-based research strategies were limited. Future research can better specify measurement of understudied equity categories, trauma types and intent, and racial groups.

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Key components and IT assistance of participant management in clinical research: a scoping review.

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Key components and IT assistance of participant management in clinical research: a scoping review.

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