Étiquette : Florian Naudet

Catégories
EN

Trends of Publication of Negative Trials Over Time

Authors : Bruno Laviolle, Clara Locher, Jean-Sébastien Allain, Quentin Le Cornu, Pierre Charpentier, Marie Lefebvre, Clémence Le Pape, Cyril Leven, Clément Palpacuer, Clémence Pontoizeau, Eric Bellissant, Florian Naudet

Studies with negative results are less likely to be published than others, potentially leading to publication bias. Introduced in 2000, trial registration could have participated in decreasing the proportion of unpublished studies. We assessed the proportion of negative randomized controlled trials (RCT) over the last 20 years.

We searched Medline for RCT published in 2000, 2005, 2010, 2015, and 2020 in the British Medical Journal, the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine. The primary endpoint was the proportion of negative (final comparison on the primary study-endpoint without statistical significance or favoring the control arm) studies published in 2000 and 2020.

Factors independently associated with the publication of negative studies were identified using multivariable analysis. A total of 1,542 studies were included. The proportion of negative RCT significantly increased between 2000 and 2020 (from 27.6% to 37.4%; P = 0.01), however, the trend over time was not significant (P = 0.203). In multivariable analysis, the following factors were associated with a higher proportion of published negative studies: superiority (P < 0.001), two-group trials (P < 0.001), number of patients ≥510 (P < 0.001), cardiology trials (P = 0.003), emergency/critical care trials (P < 0.001), obstetrics trials (P = 0.032), surgery trials (P = 0.006), pneumology trials (P = 0.029).

Exclusive industry funding was associated with a lower proportion of published negative studies (P < 0.001). The proportion of published negative studies in 2020 was higher only when compared to 2000. During the two decades, no trend was noticeable. There is no clear relationship between trial registration and the publication of negative results over time.

URL : Trends of Publication of Negative Trials Over Time

DOI : https://doi.org/10.1002/cpt.3535

Catégories
EN

Reporting of interventional clinical trial results in a French academic center: a survey of completed studies

Authors : Anne Sophie Alix Doucet, Constant VINATIER, Loïc Fin, Hervé Léna, Hélène Rangé, Clara Locher, Florian Naudet

Background: The dissemination of clinical trial results is an important scientific and ethical endeavour. This survey of completed interventional studies in a French academic center describes their reporting status.

Methods: We explored all interventional studies sponsored by Rennes University Hospital identified on the French Open Science Monitor which tracks trials registered on EUCTR or clinicaltrials.gov, and provides an automatic assessment of the reporting of results. For each study, we ascertained the actual reporting of results using systematic searches on the hospital internal database, bibliographic databases (Google Scholar, PubMed), and by contacting all principal investigators (PIs). We describe several features (including total budget and numbers of trial participants) of the studies that did not report any results.

Results: The French Open Science Monitor identified 93 interventional studies, among which 10 (11%) reported results. In contrast, our survey identified 36 studies (39%) reporting primary analysis results and an additional 18 (19%) reporting results for secondary analyses (without results for their primary analysis). The overall budget for studies that did not report any results was estimated to be €5,051,253 for a total of 6,735 trial participants. The most frequent reasons for the absence of results reported by PIs were lack of time for 18 (42%), and logistic difficulties (e.g. delay in obtaining results or another blocking factor) for 12 (28%). An association was found between non-publication and negative results (adjusted Odds Ratio = 4.70, 95% Confidence Interval [1.67;14.11]).

Conclusions: Even allowing for the fact that automatic searches underestimate the number of studies with published results, the level of reporting was disappointingly low. This amounts to a waste of trial participants’ implication and money. Corrective actions are needed.

URL : Reporting of interventional clinical trial results in a French academic center: a survey of completed studies

DOI : https://doi.org/10.21203/rs.3.rs-3782467/v1

Catégories
EN

Status, use and impact of sharing individual participant data from clinical trials: a scoping review

Authors : Christian Ohmann, David Moher, Maximilian Siebert, Edith Motschall, Florian Naudet

Objectives

To explore the impact of data-sharing initiatives on the intent to share data, on actual data sharing, on the use of shared data and on research output and impact of shared data.

Eligibility criteria

All studies investigating data-sharing practices for individual participant data (IPD) from clinical trials.

Sources of evidence

We searched the Medline database, the Cochrane Library, the Science Citation Index Expanded and the Social Sciences Citation Index via Web of Science, and preprints and proceedings of the International Congress on Peer Review and Scientific Publication.

In addition, we inspected major clinical trial data-sharing platforms, contacted major journals/publishers, editorial groups and some funders.

Charting methods

Two reviewers independently extracted information on methods and results from resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome domain.

Results

93 studies identified in the literature search (published between 2001 and 2020, median: 2018) and 5 from additional information sources were included in the scoping review. Most studies were descriptive and focused on early phases of the data-sharing process. While the willingness to share IPD from clinical trials is extremely high, actual data-sharing rates are suboptimal.

A survey of journal data suggests poor to moderate enforcement of the policies by publishers. Metrics provided by platforms suggest that a large majority of data remains unrequested. When requested, the purpose of the reuse is more often secondary analyses and meta-analyses, rarely re-analyses. Finally, studies focused on the real impact of data-sharing were rare and used surrogates such as citation metrics.

Conclusions

There is currently a gap in the evidence base for the impact of IPD sharing, which entails uncertainties in the implementation of current data-sharing policies. High level evidence is needed to assess whether the value of medical research increases with data-sharing practices.

URL : Status, use and impact of sharing individual participant data from clinical trials: a scoping review

Original location : https://bmjopen.bmj.com/content/11/8/e049228

Catégories
EN

Publication by association: how the COVID-19 pandemic has shown relationships between authors and editorial board members in the field of infectious diseases

Authors : Clara Locher, David Moher, Ioana Alina Cristea, Florian Naudet

During the COVID-19 pandemic, the rush to scientific and political judgements on the merits of hydroxychloroquine was fuelled by dubious papers which may have been published because the authors were not independent from the practices of the journals in which they appeared.

This example leads us to consider a new type of illegitimate publishing entity, ‘self-promotion journals’ which could be deployed to serve the instrumentalisation of productivity-based metrics, with a ripple effect on decisions about promotion, tenure and grant funding, but also on the quality of manuscripts that are disseminated to the medical community and form the foundation of evidence-based medicine.

DOI : http://dx.doi.org/10.1136/bmjebm-2021-111670

Catégories
EN

‘Nepotistic journals’: a survey of biomedical journals

Authors : Alexandre Scanff, Florian Naudet, Ioana Cristea, David Moher, Dorothy V M Bishop, Clara Locher

Context

Convergent analyses in different disciplines support the use of the Percentage of Papers by the Most Prolific author (PPMP) as a red flag to identify journals that can be suspected of questionable editorial practices. We examined whether this index, complemented by the Gini index, could be useful for identifying cases of potential editorial bias, using a large sample of biomedical journals.

Methods

We extracted metadata for all biomedical journals referenced in the National Library of Medicine, with any attributed Broad Subject Terms, and at least 50 authored (i.e. by at least one author) articles between 2015 and 2019, identifying the most prolific author (i.e. the person who signed the most papers in each particular journal).

We calculated the PPMP and the 2015-2019 Gini index for the distribution of articles across authors. When the relevant information was reported, we also computed the median publication lag (time between submission and acceptance) for articles authored by any of the most prolific authors and that for articles not authored by prolific authors.

For outlier journals, defined as a PPMP or Gini index above the 95th percentile of their respective distributions, a random sample of 100 journals was selected and described in relation to status on the editorial board for the most prolific author.

Results

5 468 journals that published 4 986 335 papers between 2015 and 2019 were analysed. The PPMP 95th percentile was 10.6% (median 2.9%). The Gini index 95th percentile was 0.355 (median 0.183). Correlation between the two indices was 0.35 (95CI 0.33 to 0.37). Information on publication lag was available for 2 743 journals.

We found that 277 journals (10.2%) had a median time lag to publication for articles by the most prolific author(s) that was shorter than 3 weeks, versus 51 (1.9%) journals with articles not authored by prolific author(s).

Among the random sample of outlier journals, 98 provided information about their editorial board. Among these 98, the most prolific author was part of the editorial board in 60 cases (61%), among whom 25 (26% of the 98) were editors-in-chief.

Discussion

In most journals publications are distributed across a large number of authors. Our results reveal a subset of journals where a few authors, often members of the editorial board, were responsible for a disproportionate number of publications.

The papers by these authors were more likely to be accepted for publication within 3 weeks of their submission. To enhance trust in their practices, journals need to be transparent about their editorial and peer review practices.

URL : ‘Nepotistic journals’: a survey of biomedical journals

DOI : https://doi.org/10.1101/2021.02.03.429520

Catégories
EN

Publication by association: the Covid-19 pandemic reveals relationships between authors and editors

Authors : Clara Locher, David Moher, Ioana Cristea, Florian Naudet

During the COVID-19 pandemic, the rush to scientific and political judgments on the merits of hydroxychloroquine was fuelled by dubious papers which may have been published because the authors were not independent from the practices of the journals in which they appeared.

This example leads us to consider a new type of illegitimate publishing entity, “self-promotion journals” which could be deployed to serve the instrumentalisation of productivity-based metrics, with a ripple effect on decisions about promotion, tenure, and grant funding.

URL : Publication by association: the Covid-19 pandemic reveals relationships between authors and editors

DOI : https://doi.org/10.31222/osf.io/64u3s

Catégories
Non classé

Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations

Authors : Maximilian Siebert, Jeanne Fabiola Gaba, Laura Caquelin, Henri Gouraud, Alain Dupuy, David Moher, Florian Naudet

Objective

To explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.

Design

A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).

Setting

ICMJE website; PubMed/Medline.

Eligibility criteria

ICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall’s list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018.

Main outcome measures

The primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors.

For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement.

Results

Eight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%).

One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements.

In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%).

Conclusion

The implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals.

The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future.

URL : Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations

DOI : http://dx.doi.org/10.1136/bmjopen-2020-038887