Archives des mots-clés : biomedical research

Comparison of effect estimates between preprints and peer-reviewed journal articles of COVID-19 trials

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Authors : Mauricia Davidson, Theodoros Evrenoglou, Carolina Graña, Anna Chaimani, Isabelle Boutron

Background

Preprints are increasingly used to disseminate research results, providing multiple sources of information for the same study. We assessed the consistency in effect estimates between preprint and subsequent journal article of COVID-19 randomized controlled trials.

Methods

The study utilized data from the COVID-NMA living systematic review of pharmacological treatments for COVID-19 (covid-nma.com) up to July 20, 2022. We identified randomized controlled trials (RCTs) evaluating pharmacological treatments vs. standard of care/placebo for patients with COVID-19 that were originally posted as preprints and subsequently published as journal articles.

Trials that did not report the same analysis in both documents were excluded. Data were extracted independently by pairs of researchers with consensus to resolve disagreements. Effect estimates extracted from the first preprint were compared to effect estimates from the journal article.

Results

The search identified 135 RCTs originally posted as a preprint and subsequently published as a journal article. We excluded 26 RCTs that did not meet the eligibility criteria, of which 13 RCTs reported an interim analysis in the preprint and a final analysis in the journal article. Overall, 109 preprint–article RCTs were included in the analysis.

The median (interquartile range) delay between preprint and journal article was 121 (73–187) days, the median sample size was 150 (71–464) participants, 76% of RCTs had been prospectively registered, 60% received industry or mixed funding, 72% were multicentric trials. The overall risk of bias was rated as ‘some concern’ for 80% of RCTs.

We found that 81 preprint–article pairs of RCTs were consistent for all outcomes reported. There were nine RCTs with at least one outcome with a discrepancy in the number of participants with outcome events or the number of participants analyzed, which yielded a minor change in the estimate of the effect. Furthermore, six RCTs had at least one outcome missing in the journal article and 14 RCTs had at least one outcome added in the journal article compared to the preprint. There was a change in the direction of effect in one RCT. No changes in statistical significance or conclusions were found.

Conclusions

Effect estimates were generally consistent between COVID-19 preprints and subsequent journal articles. The main results and interpretation did not change in any trial. Nevertheless, some outcomes were added and deleted in some journal articles.

URL : Comparison of effect estimates between preprints and peer-reviewed journal articles of COVID-19 trials

DOI : https://doi.org/10.1186/s12874-023-02136-8

More ethics in the laboratory, please! Scientists’ perspectives on ethics in the preclinical phase

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Authors : Paola Buedo, Eugenia Prieto, Jolanta Perek-Białas, Idalina Odziemczyk-
Stawarz, Marcin Waligora

In recent years there have been calls to improve ethics in preclinical research. Promoting ethics in preclinical research should consider the perspectives of scientists. Our study aims to explore researchers’ perspectives on ethics in the preclinical phase.

Using interviews and focus groups, we collected views on ethical issues in preclinical research from experienced (n = 11) and early-stage researchers (ESRs) (n = 14) working in a gene therapy and regenerative medicine consortium. A recurring theme among ESRs was the impact of health-related preclinical research on climate change.

They highlighted the importance of strengthening ethics in relations within the scientific community. Experienced researchers were focused on technicalities of methods used in preclinical research. They stressed the need for more safeguards to protect the sensitive personal data they work with.

Both groups drew attention to the importance of the social context of research and its social impact. They agreed that it is important to be socially responsible – to be aware of and be sensitive to the needs and views of society.

This study helps to identify key ethical challenges and, when combined with more data, can ultimately lead to informed and evidence-based improvements to existing regulations.

URL : More ethics in the laboratory, please! Scientists’ perspectives on ethics in the preclinical phase

DOI : https://doi.org/10.1080/08989621.2023.2294996

Clickbait or conspiracy? How Twitter users address the epistemic uncertainty of a controversial preprint

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Authors : Mareike Bauer, Maximilian Heimstädt, Carlos Franzreb, Sonja Schimmler

Many scientists share preprints on social media platforms to gain attention from academic peers, policy-makers, and journalists. In this study we shed light on an unintended but highly consequential effect of sharing preprints: Their contribution to conspiracy theories. Although the scientific community might quickly dismiss a preprint as insubstantial and ‘clickbaity’, its uncertain epistemic status nevertheless allows conspiracy theorists to mobilize the text as scientific support for their own narratives.

To better understand the epistemic politics of preprints on social media platforms, we studied the case of a biomedical preprint, which was shared widely and discussed controversially on Twitter in the wake of the coronavirus disease 2019 pandemic. Using a combination of social network analysis and qualitative content analysis, we compared the structures of engagement with the preprint and the discursive practices of scientists and conspiracy theorists.

We found that despite substantial engagement, scientists were unable to dampen the conspiracy theorists’ enthusiasm for the preprint. We further found that members from both groups not only tried to reduce the preprint’s epistemic uncertainty but sometimes deliberately maintained it.

The maintenance of epistemic uncertainty helped conspiracy theorists to reinforce their group’s identity as skeptics and allowed scientists to express concerns with the state of their profession.

Our study contributes to research on the intricate relations between scientific knowledge and conspiracy theories online, as well as the role of social media platforms for new genres of scholarly communication.

URL : Clickbait or conspiracy? How Twitter users address the epistemic uncertainty of a controversial preprint

DOI : https://doi.org/10.1177/20539517231180575

Establishing an early indicator for data sharing and reuse

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Authors : Agata Piękniewska, Laurel L. Haak, Darla Henderson, Katherine McNeill, Anita Bandrowski, Yvette Seger

Funders, publishers, scholarly societies, universities, and other stakeholders need to be able to track the impact of programs and policies designed to advance data sharing and reuse. With the launch of the NIH data management and sharing policy in 2023, establishing a pre-policy baseline of sharing and reuse activity is critical for the biological and biomedical community.

Toward this goal, we tested the utility of mentions of research resources, databases, and repositories (RDRs) as a proxy measurement of data sharing and reuse. We captured and processed text from Methods sections of open access biological and biomedical research articles published in 2020 and 2021 and made available in PubMed Central.

We used natural language processing to identify text strings to measure RDR mentions. In this article, we demonstrate our methodology, provide normalized baseline data sharing and reuse activity in this community, and highlight actions authors and publishers can take to encourage data sharing and reuse practices.

URL : Establishing an early indicator for data sharing and reuse

DOI : https://doi.org/10.1002/leap.1586

Enjeux, pratiques et stratégies d’ouverture de l’information scientifique en bioéconomie

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Auteur.ice : Marianne Duquenne

La bioéconomie est une opportunité en réponse aux problématiques écologiques actuelles que nous traversons. Ce nouveau paradigme contribue à une transition globale vers des modèles plus durables et respectueux de l’environnement. La mise en œuvre d’une telle stratégie sur un territoire implique nécessairement une forte interaction entre le secteur privé et le secteur public pour répondre aux défis d’innovation posés par la bioéconomie.

La région Hauts-de-France témoigne de cet écosystème composé d’acteurs de l’industrie, de la recherche, du transfert ou encore du monde de l’exploitation agricole. L’enjeu de cet article est double : d’abord, de comprendre comment ces catégories d’acteurs s’organisent pour produire des connaissances scientifiques et techniques en bioéconomie et, aussi, d’analyser le partage des résultats de la recherche entre ces acteurs.

Cette dernière question se pose de plus en plus depuis que l’État français mène une politique en faveur d’une science plus ouverte, transparente et accessible à tous. Depuis 2019, une étude de terrain est menée pour analyser l’application des principes de la science ouverte en bioéconomie.

Des entretiens menés auprès de porteurs de projets révèlent un domaine de recherche émergent, large et complexe. Tandis que les parties prenantes ont recours à des stratégies plus ou moins ouvertes pour partager les résultats de leurs travaux en recherche et développement, les résultats montrent que la mise en œuvre des principes de la science ouverte peut être impactée.

La discussion porte sur la nécessité d’être nuancé dans l’ouverture de l’information scientifique pour garantir les intérêts des partenaires industriels, et par ailleurs pour assurer le bon développement de la bioéconomie sur le territoire des Hauts-de-France.

URL : Enjeux, pratiques et stratégies d’ouverture de l’information scientifique en bioéconomie

Original location : https://revue-cossi.numerev.com/articles/revue-12/3101-enjeux-pratiques-et-strategies-d-ouverture-de-l-information-scientifique-en-bioeconomie

What’s trust got to do with research: why not accountability?

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Authors : Morẹ́nikẹ́ Oluwátóyìn Foláyan, Bridget Haire

This paper explores the intricate dynamics of trust, power, and vulnerability in the relationship between researchers and study participants/communities in the field of bioethics.

The power and knowledge imbalances between researchers and participants create a structural vulnerability for the latter. While trust-building is important between researchers and study participants/communities, the consenting process can be challenging, often burdening participants with power abrogation.

Trust can be breached. The paper highlights the contractual nature of the research relationship and argues that trust alone cannot prevent exploitation as power imbalances and vulnerabilities persist. To protect participants, bioethics guidance documents promote accountability and ethical compliance.

These documents uphold fairness in the researcher-participant relationship and safeguard the interests of socially vulnerable participants. The paper also highlights the role of shared decision-making and inclusive deliberation with diverse stakeholders and recommends that efforts should be made by researchers to clarify roles and responsibilities, while research regulatory agents should transform the research-participant relationship into a legal-based contract governed by accountability principles.

While trust remains important, alternative mechanisms may be needed to ensure ethical research practices and protect the interests of participants and communities. Striking a balance between trust and accountability is crucial in this regard.

URL : What’s trust got to do with research: why not accountability?

DOI : https://doi.org/10.3389/frma.2023.1237742

How do journals publishing palliative and end-of-life care research report ethical approval and informed consent?

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Authors : Tove Godskesen, Knut Jørgen Vie, William Bülow, Bodil Holmberg, Gert Helgesson, Stefan Eriksson

This study explores how papers published in international journals in palliative and end-of-life care report ethical approval and informed consent. A literature search following PRISMA guidelines was conducted in PubMed, the Web of Science Core Collection, Scopus, the ProQuest Social Science Premium Collection, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). A total of 169 empirical studies from 101 journals were deductively coded and analysed.

The results showed that 5% of publications provided no information on ethical approval, 12% reported minimal information, 56% reported rudimentary information, and 27% reported comprehensive details. We also found that 13% did not report any information on informed consent, 17% reported minimal information, 50% reported rudimentary information, and 19% reported comprehensive details.

The prevalence of missing and incomplete ethical statements and inadequate reporting of informed consent processes in recent publications raises concerns and highlights the need for improvement. We suggest that journals advocate high reporting standards and potentially reject papers that do not meet ethical requirements, as this is the quickest path to improvement.

URL : How do journals publishing palliative and end-of-life care research report ethical approval and informed consent?

DOI : https://doi.org/10.1002/leap.1580