Dataset Information

The methodological quality of animal research in critical care: the public face of science.

ABSTRACT:

Background

Animal research (AR) findings often do not translate to humans; one potential reason is the poor methodological quality of AR. We aimed to determine this quality of AR reported in critical care journals.

Methods

All AR published from January to June 2012 in three high-impact critical care journals were reviewed. A case report form and instruction manual with clear definitions were created, based on published recommendations, including the ARRIVE guidelines. Data were analyzed with descriptive statistics.

Results

Seventy-seven AR publications were reviewed. Our primary outcome (animal strain, sex, and weight or age described) was reported in 52 (68%; 95% confidence interval, 56% to 77%). Of the 77 publications, 47 (61%) reported randomization; of these, 3 (6%) reported allocation concealment, and 1 (2%) the randomization procedure. Of the 77 publications, 31 (40%) reported some type of blinding; of these, disease induction (2, 7%), intervention (7, 23%), and/or subjective outcomes (17, 55%) were blinded. A sample size calculation was reported in 4/77 (5%). Animal numbers were missing in the Methods section in 16 (21%) publications; when stated, the median was 32 (range 6 to 320; interquartile range, 21 to 70). Extra animals used were mentioned in the Results section in 31 (40%) publications; this number was unclear in 23 (74%), and >100 for 12 (16%). When reporting most outcomes, numbers with denominators were given in 35 (45%), with no unaccounted numbers in 24 (31%), and no animals excluded from analysis in 20 (26%). Most (49, 64%) studies reported >40, and another 19 (25%) reported 21 to 40 statistical comparisons. Internal validity limitations were discussed in 7 (9%), and external validity (to humans) discussed in 71 (92%), most with no (30, 42%) or only a vague (9, 13%) limitation to this external validity mentioned.

Conclusions

The reported methodological quality of AR was poor. Unless the quality of AR significantly improves, the practice may be in serious jeopardy of losing public support.

SUBMITTER: Bara M

PROVIDER: S-EPMC4126494 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

The methodological quality of animal research in critical care: the public face of science.

Bara Meredith M Joffe Ari R AR

Annals of intensive care 20140729

<h4>Background</h4>Animal research (AR) findings often do not translate to humans; one potential reason is the poor methodological quality of AR. We aimed to determine this quality of AR reported in critical care journals.<h4>Methods</h4>All AR published from January to June 2012 in three high-impact critical care journals were reviewed. A case report form and instruction manual with clear definitions were created, based on published recommendations, including the ARRIVE guidelines. Data were an ...[more]

PMID: 25114829

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Project description:ObjectivesTo evaluate the methodological quality of randomised controlled trial (RCT) abstracts in leading critical care nursing journals against the Consolidated Standards of Reporting Trials-Abstracts (CONSORT-A) checklist and to identify variables related with abstract reporting quality.DesignDescriptive methodological quality review.Data sourceWe searched the PubMed database and the websites of each included journal.Eligibility criteriaWe included RCT abstracts published between 2011 and 2021 in the first 11 Scopus-ranking (2021) critical care nursing journals that reported the results of RCTs in English that referred to the care of adult patients with acute/critical illness or their relatives and/or caregivers and conducted in ICUs.Data extraction and synthesisTwo independent investigators extracted the data using a prespecified 17-item checklist directly derived from CONSORT-A. For the primary outcome, each item was evaluated whether it was adequately reported or not and descriptive statistics were reported. An overall score was calculated by summing the results of all items and multivariate linear regression was conducted to detect potential predictors.ResultsSeventy-eight RCT abstracts were included in this review. The items with the highest CONSORT-A adherence were authors, objective, conclusion, participants, interventions and outcome. The randomisation item had the lowest CONSORT-A adherence, followed by trial registration, funding source, harms or side effects, recruitment, blinding and outcome results. The average CONSORT-A score was 8.5±1.5 points (of the maximum 17.5 points). Multivariate analysis indicated that the categorised word score and publication date were positively associated with the overall CONSORT-A score, while the first author's country being in Asia was negatively associated with the overall CONSORT-A score.ConclusionsThe 78 RCT abstracts showed poor overall adherence to CONSORT-A. The results indicate that the methodological reporting quality of RCT abstracts in critical care nursing journals requires improvement to facilitate assessment of the applicability and relevance of the results reported.

Project description:BackgroundTo determine a direct measure of publication bias by determining subsequent full-paper publication (P) of studies reported in animal research abstracts presented at an international conference (A).MethodsWe selected 100 random (using a random-number generator) A from the 2008 Society of Critical Care Medicine Conference. Using a data collection form and study manual, we recorded methodology and result variables from A. We searched PubMed and EMBASE to June 2015, and DOAJ and Google Scholar to May 2017 to screen for subsequent P. Methodology and result variables were recorded from P to determine changes in reporting from A. Predictors of P were examined using Fisher's Exact Test.Results62% (95% CI 52-71%) of studies described in A were subsequently P after a median 19 [IQR 9-33.3] months from conference presentation. Reporting of studies in A was of low quality: randomized 27% (the method of randomization and allocation concealment not described), blinded 0%, sample-size calculation stated 0%, specifying the primary outcome 26%, numbers given with denominators 6%, and stating number of animals used 47%. Only being an orally presented (vs. poster presented) A (14/16 vs. 48/84, p = 0.025) predicted P. Reporting of studies in P was of poor quality: randomized 39% (the method of randomization and allocation concealment not described), likely blinded 6%, primary outcome specified 5%, sample size calculation stated 0%, numbers given with denominators 34%, and number of animals used stated 56%. Changes in reporting from A to P occurred: from non-randomized to randomized 19%, from non-blinded to blinded 6%, from negative to positive outcomes 8%, from having to not having a stated primary outcome 16%, and from non-statistically to statistically significant findings 37%. Post-hoc, using publication data, P was predicted by having positive outcomes (published 62/62, unpublished 33/38; p = 0.003), or statistically significant results (published 58/62, unpublished 20/38; p < 0.001).ConclusionsOnly 62% (95% CI 52-71%) of animal research A are subsequently P; this was predicted by oral presentation of the A, finally having positive outcomes, and finally having statistically significant results. Publication bias is prevalent in critical care animal research.

Project description:BackgroundFollowing the initial identification of the 2019 coronavirus disease (covid-19), the subsequent months saw substantial increases in published biomedical research. Concerns have been raised in both scientific and lay press around the quality of some of this research. We assessed clinical research from major clinical journals, comparing methodological and reporting quality of covid-19 papers published in the first wave (here defined as December 2019 to May 2020 inclusive) of the viral pandemic with non-covid papers published at the same time.MethodsWe reviewed research publications (print and online) from The BMJ, Journal of the American Medical Association (JAMA), The Lancet, and New England Journal of Medicine, from first publication of a covid-19 research paper (February 2020) to May 2020 inclusive. Paired reviewers were randomly allocated to extract data on methodological quality (risk of bias) and reporting quality (adherence to reporting guidance) from each paper using validated assessment tools. A random 10% of papers were assessed by a third, independent rater. Overall methodological quality for each paper was rated high, low or unclear. Reporting quality was described as percentage of total items reported.ResultsFrom 168 research papers, 165 were eligible, including 54 (33%) papers with a covid-19 focus. For methodological quality, 18 (33%) covid-19 papers and 83 (73%) non-covid papers were rated as low risk of bias, OR 6.32 (95%CI 2.85 to 14.00). The difference in quality was maintained after adjusting for publication date, results, funding, study design, journal and raters (OR 6.09 (95%CI 2.09 to 17.72)). For reporting quality, adherence to reporting guidelines was poorer for covid-19 papers, mean percentage of total items reported 72% (95%CI:66 to 77) for covid-19 papers and 84% (95%CI:81 to 87) for non-covid.ConclusionsAcross various measures, we have demonstrated that covid-19 research from the first wave of the pandemic was potentially of lower quality than contemporaneous non-covid research. While some differences may be an inevitable consequence of conducting research during a viral pandemic, poor reporting should not be accepted.

Dataset Information

The methodological quality of animal research in critical care: the public face of science.

Background

Methods

Results

Conclusions

Publications

The methodological quality of animal research in critical care: the public face of science.

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