Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials

BACKGROUND: Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials. METHODS: We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials. We then interviewed 13 participants from different subspecialties and geographic locations to gain a more detailed description of how their experiences and attitudes towards research interacted with trial design and conduct. RESULTS: The survey response rate was 23.0% (186/807). 68.1% of respondents agreed that bias is a problem in pediatric RCTs and 72.0% felt that there is sufficient evidence to support changing some aspects of how trials are conducted. Knowledge related to bias was variable, with inconsistent awareness of study design features that may introduce bias into a study. Interview participants highlighted a lack of formal training in research methods, a negative research culture, and the pragmatics of trial conduct as barriers. Facilitators included contact with knowledgeable and supportive colleagues and infrastructure for research. CONCLUSIONS: A lack of awareness of bias and negative attitudes towards research present significant barriers in terms of conducting methodologically rigorous pediatric RCTs. Knowledge translation efforts must focus on these issues to ensure the relevance and validity of trial results

Consensus guidelines for the use and interpretation of angiogenesis assays

The formation of new blood vessels, or angiogenesis, is a complex process that plays important roles in growth and development, tissue and organ regeneration, as well as numerous pathological conditions. Angiogenesis undergoes multiple discrete steps that can be individually evaluated and quantified by a large number of bioassays. These independent assessments hold advantages but also have limitations. This article describes in vivo, ex vivo, and in vitro bioassays that are available for the evaluation of angiogenesis and highlights critical aspects that are relevant for their execution and proper interpretation. As such, this collaborative work is the first edition of consensus guidelines on angiogenesis bioassays to serve for current and future reference

Quantifying bias in randomized controlled trials in child health: a meta-epidemiological study.

OBJECTIVE: To quantify bias related to specific methodological characteristics in child-relevant randomized controlled trials (RCTs). DESIGN: Meta-epidemiological study. DATA SOURCES: We identified systematic reviews containing a meta-analysis with 10-40 RCTs that were relevant to child health in the Cochrane Database of Systematic Reviews. DATA EXTRACTION: Two reviewers independently assessed RCTs using items in the Cochrane Risk of Bias tool and other study factors. We used meta-epidemiological methods to assess for differences in effect estimates between studies classified as high/unclear vs. low risk of bias. RESULTS: We included 287 RCTs from 17 meta-analyses. The proportion of studies at high/unclear risk of bias was: 79% sequence generation, 83% allocation concealment, 67% blinding of participants, 47% blinding of outcome assessment, 49% incomplete outcome data, 32% selective outcome reporting, 44% other sources of bias, 97% overall risk of bias, 56% funding, 35% baseline imbalance, 13% blocked randomization in unblinded trials, and 1% early stopping for benefit. We found no significant differences in effect estimates for studies that were high/unclear vs. low risk of bias for any of the risk of bias domains, overall risk of bias, or other study factors. CONCLUSIONS: We found no differences in effect estimates between studies based on risk of bias. A potential explanation is the number of trials included, in particular the small number of studies with low risk of bias. Until further evidence is available, reviewers should not exclude RCTs from systematic reviews and meta-analyses based solely on risk of bias particularly in the area of child health

Education in Health Research Methodology: Use of a Wiki for Knowledge Translation

<div><p>Introduction</p><p>A research-practice gap exists between what is known about conducting methodologically rigorous randomized controlled trials (RCTs) and what is done. Evidence consistently shows that pediatric RCTs are susceptible to high risk of bias; therefore novel methods of influencing the design and conduct of trials are required. The objective of this study was to develop and pilot test a wiki designed to educate pediatric trialists and trainees in the principles involved in minimizing risk of bias in RCTs. The focus was on preliminary usability testing of the wiki.</p><p>Methods</p><p>The wiki was developed through adaptation of existing knowledge translation strategies and through tailoring the site to the identified needs of the end-users. The wiki was evaluated for usability and user preferences regarding the content and formatting. Semi-structured interviews were conducted with 15 trialists and systematic reviewers, representing varying levels of experience with risk of bias or the conduct of trials. Data were analyzed using content analysis.</p><p>Results</p><p>Participants found the wiki to be well organized, easy to use, and straightforward to navigate. Suggestions for improvement tended to focus on clarification of the text or on esthetics, rather than on the content or format. Participants liked the additional features of the site that were supplementary to the text, such as the interactive examples, and the components that focused on practical applications, adding relevance to the theory presented. While the site could be used by both trialists and systematic reviewers, the lack of a clearly defined target audience caused some confusion among participants.</p><p>Conclusions</p><p>Participants were supportive of using a wiki as a novel educational tool. The results of this pilot test will be used to refine the risk of bias wiki, which holds promise as a knowledge translation intervention for education in medical research methodology.</p></div

Exploring Differences in the Clinical Management of Pediatric Mental Health in the Emergency Department

Objective: We examine psychiatric and pediatric clinical management of pediatric mental health in the emergency department (ED). Methods: We conducted a retrospective review of health care delivery with a random sample of all pediatric mental health presentations (≤18 years) to 2 urban tertiary care EDs between 2004 and 2006 (N = 580). Results: The EDs differed significantly in services offered. General emergency medicine-trained physicians provided care at 1 site (54.6%) with a number of visits also managed by a psychiatric crisis team (45.4%). Care at the other ED was delivered by pediatric emergency medicine-trained physicians (99.4%) with no regular on-site psychiatric services. The most common assessment provided across sites and all presentations was for suicidality (66.2%). After controlling for potential confounders, receipt of clinical assessment for homicidality, mood, or reality testing differed between EDs (P = 0.044, P = 0.006, and P = 0.002) with more assessments documented at the psychiatric-resourced ED. Brief counseling was lacking for visits (absence of documentation: 56.1% pediatric-resourced, 23.1% psychiatric-resourced ED); there was no evidence of site differences in provision. More psychiatric consultation was provided at the psychiatric-resourced ED (34.1% vs 27.4%, P = 0.030). Discharge recommendations were lacking in both EDs but were more incomplete for pediatric-resourced ED visits (P = 0.035). Conclusions: Consistent and comprehensive clinical management of pediatric mental health presentations was lacking in EDs that had pediatric and psychiatric resources. Prospective evaluations are needed to determine the effect of current clinical ED practices on patient and family outcomes, including symptom reduction and stress, as well as subsequent system use

Description of meta-analyses included in sample.

<p>* where totals do not equal number of studies, the balance of studies did not report this variable.</p

Risk of bias assessments by domain (N = 287).

<p>Risk of bias assessments by domain (N = 287).</p

Guía ESC/EACTS 2017 sobre el tratamiento de las valvulopatías

[No abstract available