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Incomplete reporting of experimental studies and items associated with risk of bias in veterinary research.

ABSTRACT: In in vivo research, the reporting of core items of study design is persistently poor, limiting assessment of study quality and study reproducibility. This observational cohort study evaluated reporting levels in the veterinary literature across a range of species, journals and research fields. Four items (randomisation, sample size estimation, blinding and data exclusion) were assessed as well as availability of study data in publicly accessible repositories. From five general and five subject-specific journals, 120 consecutively published papers (12 per journal) describing in vivo experimental studies were selected. Item reporting was scored using a published scale (items ranked as fully, partially or not reported) according to completeness of reporting. Papers in subject-specific journals had higher median reporting levels (50.0 per cent vs 33.3 per cent, P=0.007). In subject-specific journals, randomisation (75.0 per cent vs 41.7 per cent, P=0.0002) and sample size estimation (35.0 per cent vs 16.7 per cent, P=0.025) reporting was approximately double that of general journals. Blinding (general 48.3 per cent, subject-specific 50.0 per cent,?P=0.86) and data exclusion (general 53.3 per cent, subject-specific 63.3 per cent,?P=0.27) were similarly reported. A single paper made study data readily accessible. Incomplete reporting remains prevalent in the veterinary literature irrespective of journal type, research subject or species. This impedes evaluation of study quality and reproducibility, raising concerns regarding wasted financial and animal resources.

SUBMITTER: Rufiange M

PROVIDER: S-EPMC6541106 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Incomplete reporting of experimental studies and items associated with risk of bias in veterinary research.

Rufiange Maxime M Rousseau-Blass Frédérik F Pang Daniel S J DSJ

Veterinary record open 20190411 1

In in vivo research, the reporting of core items of study design is persistently poor, limiting assessment of study quality and study reproducibility. This observational cohort study evaluated reporting levels in the veterinary literature across a range of species, journals and research fields. Four items (randomisation, sample size estimation, blinding and data exclusion) were assessed as well as availability of study data in publicly accessible repositories. From five general and five subject- ...[more]

PMID: 31205725

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Project description:Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors. The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting. We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is. For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles.We identified reporting bias in 40 indications comprising around 50 different pharmacological, surgical (e.g. vacuum-assisted closure therapy), diagnostic (e.g. ultrasound), and preventive (e.g. cancer vaccines) interventions. Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions: depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma. Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication. The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions.In conclusion, reporting bias is a widespread phenomenon in the medical literature. Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale. This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.

Project description:IntroductionLarge sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesise data from several studies, increasing sample size and consequently power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging due to poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies. The aim of this project is to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline. The STROPS guideline will facilitate the conduct of high-quality meta-analyses and thus improve the power to detect genetic associations.Methods and analysisWe will establish a preliminary checklist of reporting items to be considered for inclusion in the guideline. We will then conduct a Delphi survey of key stakeholder groups to gain consensus opinion on which reporting items to include in the final guideline. The Delphi survey will consist of two rounds: the first round will invite participants to score items from the preliminary checklist and to suggest additional relevant items; the second round will provide feedback from the previous round and invite participants to re-score the items. Following the second round, we will summarise the distribution of scores for each item, stratified by stakeholder group. The Steering Committee for the project and representatives from the key stakeholder groups will meet to consider the results of the Delphi survey and to finalise the list of reporting items. We will then draft, pilot-test and publish the STROPS reporting guideline and accompanying explanatory document.Ethics and disseminationThe University of Liverpool Ethics Committee has confirmed ethical approval for this study (reference: 3586). Dissemination activities will include presenting the reporting guideline at conferences relevant to pharmacogenetic research.

Project description:ObjectivesWithin cost-effectiveness models, prevalence figures can inform transition probabilities. The methodological quality of studies can inform the choice of prevalence figures but no single obvious candidate tool exists for assessing quality of the observational epidemiological studies for selecting prevalence estimates. We aimed to compare different tools to assess the risk of bias of studies reporting prevalence, and develop and compare possible numerical scoring systems using these tools to set a threshold for inclusion of reports of prevalence in an economic analysis of neonatal hypoglycaemia.DesignAssessments of bias using two tools (Joanna Briggs Institute (JBI) Checklist for Prevalence Studies and a modified version of Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I)) were compared for 18 studies relevant to a single setting (neonatal hypoglycaemia). Inclusions of studies for use in a decision analysis model were considered based on summary scores derived from these tools.ResultsBoth tools were considered easy to use and produced dispersed scores for each of the 40 study-outcome combinations. The modified ROBINS-I scores were more skewed than the JBI scores, particularly at higher thresholds. The studies selected for inclusion are generally the same using either tool; if 50% was used as the cut-off threshold using the Applicable Score both tools would yield the same results. However, the JBI tool is shorter and may be easier to interpret and apply to studies that do not involve a control group, while the modified ROBINS-I tool assesses more methodological detail in studies that include a control group.ConclusionBoth tools performed well for systematically assessing studies that report on outcome prevalence and provided similar discrimination between studies for risk of bias. This convergent validity supports use of both tools for the purpose of assessing risk of bias and selecting studies that report prevalence for inclusion in economic analyses.

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Incomplete reporting of experimental studies and items associated with risk of bias in veterinary research.

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Incomplete reporting of experimental studies and items associated with risk of bias in veterinary research.

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