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Reproducibility of clinical research in critical care: a scoping review.

ABSTRACT: 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.

SUBMITTER: Niven DJ

PROVIDER: S-EPMC5820784 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Reproducibility of clinical research in critical care: a scoping review.

Niven Daniel J DJ McCormick T Jared TJ Straus Sharon E SE Hemmelgarn Brenda R BR Jeffs Lianne L Barnes Tavish R M TRM Stelfox Henry T HT

BMC medicine 20180221 1

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 29463308

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Project description:IntroductionEvidence from randomized controlled trials (RCTs) is required to guide treatment of critically ill children, but the number of RCTs available is limited and the publications are often difficult to find. The objectives of this review were to systematically identify RCTs in pediatric critical care and describe their methods and reporting.MethodsWe searched MEDLINE, EMBASE, LILACS and CENTRAL (from inception to April 16, 2013) and reference lists of included RCTs and relevant systematic reviews. We included published RCTs administering any intervention to children in a pediatric ICU. We excluded trials conducted in neonatal ICUs, those enrolling exclusively preterm infants, and individual patient crossover trials. Pairs of reviewers independently screened studies for eligibility, assessed risk of bias, and abstracted data. Discrepancies were resolved by consensus.ResultsWe included 248 RCTs: 45 (18%) were multicentered and 14 (6%) were multinational. Trials most frequently enrolled both medical and surgical patients (43%) but postoperative cardiac surgery was the single largest population studied (19%). The most frequently evaluated types of intervention were medications (63%), devices (11%) and nutrition (8%). Laboratory or physiological measurements were the most frequent type of primary outcomes (18%). Half of these trials (50%) reported blinding. Of the 107 (43%) trials that reported an a priori sample size, 34 (32%) were stopped early. The median number of children randomized per trial was 49 and ranged from 6 to 4,947. The frequency of RCT publications increased at a mean rate of 0.7 RCTs per year (P<0.001) from 1 to 20 trials per year.ConclusionsThis scoping review identified the available RCTs in pediatric critical care and made them accessible to clinicians and researchers (http://epicc.mcmaster.ca). Most focused on medications and intermediate or surrogate outcomes, were single-centered and were conducted in North America and Western Europe. The results of this review underscore the need for trials with rigorous methodology, appropriate outcome measures, and improved quality of reporting to ensure that high quality evidence exists to support clinical decision-making in this vulnerable population.

Project description:ObjectivesThe purpose of this scoping review is to provide a synthesis of the available literature on implementation science in critical care settings. Specifically, we aimed to identify the evidence-based practices selected for implementation, the frequency and type of implementation strategies used to foster change, and the process and clinical outcomes associated with implementation.Data sourcesA librarian-assisted search was performed using three electronic databases.Study selectionArticles that reported outcomes aimed at disseminating, implementing, or sustaining an evidence-based intervention or practice, used established implementation strategies, and were conducted in a critical care unit were included.Data extractionTwo reviewers independently screened titles, abstracts, and full text of articles to determine eligibility. Data extraction was performed using customized fields established a priori within a systematic review software system.Data synthesisOf 1,707 citations, 82 met eligibility criteria. Studies included prospective research investigations, quality improvement projects, and implementation science trials. The most common practices investigated were use of a ventilator-associated pneumonia bundle, nutritional support protocols, and the Awakening and Breathing Coordination, Delirium Monitoring/Management, and Early Exercise/Mobility bundle. A variety of implementation strategies were used to facilitate evidence adoption, most commonly educational meetings, auditing and feedback, developing tools, and use of local opinion leaders. The majority of studies (76/82, 93%) reported using more than one implementation strategy. Few studies specifically used implementation science designs and frameworks to systematically evaluate both implementation and clinical outcomes.ConclusionsThe field of critical care has experienced slow but steady gains in the number of investigations specifically guided by implementation science. However, given the exponential growth of evidence-based practices and guidelines in this same period, much work remains to critically evaluate the most effective mechanisms to integrate and sustain these practices across diverse critical care settings and teams.

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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Reproducibility of clinical research in critical care: a scoping review.

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Reproducibility of clinical research in critical care: a scoping review.

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