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Many researchers were not compliant with their published data sharing statement: a mixed-methods study
by
Puljak, Livia
,
Gabelica, Mirko
,
Bojčić, Ružica
in
Availability
,
Data availability statement
,
Data sharing
2022
The objective of the study was to analyze researchers’ compliance with their data availability statement (DAS) from manuscripts published in open-access journals with the mandatory DAS.
We analyzed all articles from 333 open-access journals published during January 2019 by BioMed Central. We categorized types of the DAS. We surveyed corresponding authors who wrote in the DAS that they would share the data. Consent to participate in the study was sought for all included manuscripts. After accessing raw data sets, we checked whether data were available in a way that enabled reanalysis.
Of 3556 analyzed articles, 3416 contained the DAS. The most frequent DAS category (42%) indicated that the data sets are available on reasonable request. Among 1792 manuscripts in which the DAS indicated that authors are willing to share their data, 1669 (93%) authors either did not respond or declined to share their data with us. Among 254 (14%) of 1792 authors who responded to our query for data sharing, only 123 (6.8%) provided the requested data.
Even when authors indicate in their manuscript that they will share data upon request, the compliance rate is the same as for authors who do not provide the DAS, suggesting that the DAS may not be sufficient to ensure data sharing.
Journal Article
Metaresearch for Evaluating Reproducibility in Ecology and Evolution
2017
Recent replication projects in other disciplines have uncovered disturbingly low levels of reproducibility, suggesting that those research literatures may contain unverifiable claims. The conditions contributing to irreproducibility in other disciplines are also present in ecology. These include a large discrepancy between the proportion of “positive” or “significant” results and the average statistical power of empirical research, incomplete reporting of sampling stopping rules and results, journal policies that discourage replication studies, and a prevailing publish-or-perish research culture that encourages questionable research practices. We argue that these conditions constitute sufficient reason to systematically evaluate the reproducibility of the evidence base in ecology and evolution. In some cases, the direct replication of ecological research is difficult because of strong temporal and spatial dependencies, so here, we propose metaresearch projects that will provide proxy measures of reproducibility.
Journal Article
Yet another problem with systematic reviews: a living review update
by
Falzon, Louise
,
Uttley, Lesley
,
Weng, Yuliang
in
Author influence
,
Authorship
,
Cardiovascular disease
2025
In February 2023, the Journal of Clinical Epidemiology published ‘The Problems with Systematic Reviews: A Living Systematic Review.’ In updating this living review for the first time a new problem and several themes relating to research culture have emerged.
Literature searches were rerun to identify articles published or indexed between May 2022 and May 2023. Thematic analysis coded articles and problems across four domains of systematic review conduct (1. comprehensive, 2. rigour, 3. transparent, 4. objective).
One hundred fifty-two newly included articles bring the total number of relevant articles to 637. A new problem (the lack of gender diversity of systematic review author teams) brings the total number of problems with systematic reviews up to 68. This update also reveals emerging themes such as: fast science from systematic reviews on COVID-19; the failure of citation of methodological or reporting guidelines to predict high-quality methodological or reporting quality; and the influence of vested interests on systematic review conclusions. These findings coupled with a proliferation of research waste from “me-too” meta-research articles highlighting well-established problems in systematic reviews underscores the need for reforms in research culture to address the incentives for producing and publishing research papers. This update also reports where the identified flaws in systematic reviews affect their conclusions drawing on 77 meta-epidemiological studies from the total 637 included articles. These meta-meta-analytic studies begin the important work of examining which problems threaten the reliability and validity of treatment effects or conclusions derived from systematic reviews.
This living review has captured an emerging theme in the published literature relating to the composition of the review author team and highlights a potential effect on the equity reporting of the systematic reviews. We recommend that meta-research endeavors evolve from merely documenting well-established issues to understanding lesser-known problems or consequences to systematic reviews.
[Display omitted]
•Updated living review brings the number of systematic review problems up to 68.•Team gender diversity correlates with reporting equity characteristics in reviews.•Research culture influences: fast science; research waste; conflicts of interest.•Some included articles study how problems affect reliability/validity of conclusions.•Metaresearch should progress forward from documenting well-established problems.
Journal Article
Reusing clinical trial data to consolidate and advance medical knowledge
by
Ross, Joseph S.
,
Varvarà, Giulia
,
Burgwinkel, Cora
in
Blood pressure
,
Clinical trials
,
Clinical Trials as Topic
2025
While data sharing holds great potential to maximize the value of research and reduce waste, these benefits can only be fully realized if shared data are also effectively reused. Yet, data reuse remains limited, and there is a notable lack of clear guidelines to support data reusers. Reusing existing data enables a wide range of valuable activities, including validating previous findings, identifying errors, conducting individual patient data meta-analyses, performing secondary analyses, and developing or testing new methods. However, the validity of such work depends on strict adherence to reproducible research practices—arguably even more so in the context of secondary use. Data reuse also involves practical constraints and specific challenges, such as addressing feasibility issues, which must be anticipated and managed from the outset. Researchers should remain aware of these considerations throughout the entire lifecycle of a reuse study. Ideally, this process should be supported by hands-on training tailored to the specific demands of data reuse. To that end, we propose a set of guiding principles to foster responsible and meaningful reuse of existing datasets—including, but not limited to, assembling a skilled multidisciplinary team, anticipating infrastructure and interoperability challenges, maintaining transparency throughout the research process, and incentivizing all stakeholders involved.
Journal Article
The majority of reporting guidelines are not developed with the Delphi method: a systematic review of reporting guidelines
by
Kataoka, Yuki
,
Tsujimoto, Yasushi
,
Banno, Masahiro
in
Archives & records
,
Clinical epidemiology
,
Clinical trials
2020
Previous guidance of reporting guidelines recommends incorporating the Delphi method to integrate the opinions of experts for consensus when developing reporting guidelines. The purpose of this study was to clarify whether reporting guidelines typically use the Delphi method, what factors may be associated with the use of Delphi, and the reporting quality of Delphi.
We included all reporting guidelines (n = 244) in the Enhancing the QUAlity and Transparency of health Research (EQUATOR) Network published after January 1, 2011. We assessed the trends and factors associated with conducting Delphi and the reporting quality of Delphi against current reporting guidelines.
Of 244, 62 (25%) used Delphi for consensus building. The proportion of reporting guidelines that used Delphi was less than 10% in 2011 and 2012 and 29% in 2019. The year of publication, number of authors, and multiple and simultaneous publications were associated with the use of Delphi. The reporting quality of the Delphi method was moderate in most reporting guidelines developed with Delphi.
The use of Delphi in reporting guidelines is insufficient. Users and reviewers should carefully appraise the consensus building in the guidelines.
We applied a prespecified protocol to conduct this study (Banno M, Tsujimoto Y, Kataoka Y. Reporting quality of the Delphi technique in reporting guidelines: a protocol for a systematic analysis of the EQUATOR Network Library. BMJ Open. 2019; 9:e024942). The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (Trial registration number: UMIN000032685, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037271).
Journal Article
Characteristics, consent patterns, and challenges of randomized trials using the Trials within Cohorts (TwiCs) design - A scoping review
by
Speich, Benjamin
,
Amstutz, Alain
,
Hemkens, Lars G.
in
Clinical trials
,
cmRCT
,
Cohort analysis
2024
Trials within Cohorts (TwiCs) is a pragmatic design approach that may overcome frequent challenges of traditional randomized trials such as slow recruitment, burdensome consent procedures, or limited external validity. This scoping review aims to identify all randomized controlled trials using the TwiCs design and to summarize their design characteristics, ways to obtain informed consent, output, reported challenges and mitigation strategies.
Systematic search of Medline, Embase, Cochrane, trial registries and citation tracking up to December 2022. TwiCs were defined as randomized trials embedded in a cohort with postrandomization consent for the intervention group and no specific postrandomization consent for the usual care control group. Information from identified TwiCs was extracted in duplicate from protocols, publications, and registry entries. We analyzed the information descriptively and qualitatively to highlight methodological challenges and solutions related to nonuptake of interventions and informed consent procedure.
We identified a total of 46 TwiCs conducted between 2005 and 2022 in 14 different countries by a handful of research groups. The most common medical fields were oncology (11/46; 24%), infectious diseases (8/46; 17%), and mental health (7/46; 15%). A typical TwiCs was investigator-initiated (46/46; 100%), publicly funded (36/46; 78%), and recruited outpatients (27/46; 59%). Excluding eight pilot trials, only 16/38 (42%) TwiCs adjusted their calculated sample size for nonuptake of the intervention, anticipating a median nonuptake of 25% (interquartile range 10%-32%) in the experimental arm. Seventeen TwiCs (45%) planned analyses to adjust effect estimates for nonuptake. Regarding informed consent, we observed three patterns: 1) three separate consents for cohort participation, randomization, and intervention (17/46; 37%); 2) combined consent for cohort participation and randomization and a separate intervention consent (10/46; 22%); and 3) consent only for cohort participation and intervention (randomization consent not mentioned; 19/46; 41%).
Existing TwiCs are globally scattered across a few research groups covering a wide range of medical fields and interventions. Despite the potential advantages, the number of TwiCs remains small. The variability in consent procedures and the possibility of substantial nonuptake of the intervention warrants further research to guide the planning, implementation, and analysis of TwiCs.
Journal Article
Metaresearch study highlights the gender gap in randomized controlled trials in dentistry
by
Prado, Mayara Colpo
,
Sarkis-Onofre, Rafael
,
Agostini, Bernardo Antonio
in
Authorship
,
Bibliometrics
,
Citation analysis
2023
This study aimed to assess the gender gap in randomized controlled trials (RCTs) in dentistry in terms of authorship, collaborations, metrics, funding and reporting of good research practice and transparecy.
The search was performed in PubMed for RCTs restricted to English texts in the dental field, indexed from 12/31/2016 to 12/31/2021. Two reviewers screened the studies in line with the eligibility criteria. A total of 844 articles were included. The name and gender of authors, citation metrics, funding, reporting of characteristics of good research practice and transparency were extracted. We considered \"collaboration between authors\" when the corresponding author was different from the first author.
The proportion of women as first authors was 46.56% and 40.12% for corresponding authors. The analysis showed that when a woman is the corresponding author, the probability of the first author also being a woman is 57% higher compared to the first author being a man. For “protocol registration” and “data sharing,” the prevalence of reporting was higher when women were first authors.
A gender gap in dentistry RCTs was identified and related to the participation of women as first and corresponding authors and the collaboration between authors.
Journal Article
Patterns of preregistration and publication of trials in Cochrane systematic reviews of interventions
by
Bird, Caroline
,
Badgett, Robert
,
DeVito, Nicholas J.
in
Bias
,
Classification
,
Clinical trials
2025
It is widely recognized that selective reporting clinical trial results based on their outcomes, in the forms of publication bias, outcome reporting bias, or p-hacking, has detrimental effects on the scientific literature and on evidence synthesis. This can be recognized and perhaps ameliorated with comprehensive trial registration. However, previous investigations of clinical trial registration focused on study-level examinations rather than the number of trial participants, which is often more relevant to meta-analysis. Our objective was to investigate the risk of bias from selective reporting considering both trials but also the number of included participants.
We took a random sample of 50 Cochrane systematic reviews (SRs) of interventions which included randomized controlled trials, forming a retrospective cohort. Focusing on the primary outcome in the SR we used the review, published trial information, and public trial registration documents to collect information about the reviews themselves, as well as information about “included,” “ongoing,” and studies “awaiting classification”.
In all 50 selected reviews, there were 423 “included” trials which examined the primary outcome, of which 109 (25.7%) were preregistered. There was substantial variability in proportions of preregistration of included trials among reviews, with a median of 16.0% (interquartile range 0%−79.6%). Registered trials covered 60.1% of all participants, suggesting larger studies were more likely to be preregistered. The proportion of participants in registered trials which were published was high (98.2%), but the proportion of registered trials which were published also varied substantially between reviews.
We found that in Cochrane reviews, there remains a low rate of preregistration among included studies and evidence for a substantial rate of trial nonreporting of registered trials. However, preregistered trials contributed proportionally more patients to reviews, and findings remain unpublished for only a small proportion of participants in registered trials.
Trials are an important form of evidence in scientific literature that are often combined into systematic reviews (SRs), which give an overview for the evidence in a specific topic. However, trials and therefore the reviews can be misleading when the authors change the outcomes that they report based on the results they find, which is called reporting bias. One way of minimizing reporting bias is to register the planned methods for the trial in advance, known as preregistration. It is known that the proportion of trials that is registered can be low, but when conducting SRs the results are affected more by the number of participants within trials than the number of trials, which has not been previously studied. We aimed to make an up-to-date estimate of the proportion of preregistered trials in Cochrane SRs but also find out the proportion of participants within registered trials in these reviews. To do this we took a random sample of 50 Cochrane SRs, which conduct careful searches for registered trials whether or not they are published, and examined the trials within these reviews that studied the outcome the review declared to be most important. We found that even in modern SRs, only 25% of trials were preregistered, and that this number was very variable in reviews of different clinical questions. However we found that 60% of the patients in the reviews were within the preregistered trials, indicating that preregistered trials are generally larger than unregistered trials. We also found that more than 90% of preregistered studies were published. However, a major problem with this approach is that we cannot detect trials that were started without registration and then never published, which means that our results may underestimate the problem. Overall, this indicates that the risk of reporting bias is somewhat lower when considering participants rather than trials, but the risk of reporting bias is still high even in modern, rigorous reviews in medical science.
•Selective reporting of trials can bias the literature and affect evidence synthesis.•The rate of preregistration of clinical trials remains low.•Preregistered studies have more participants than comparable unregistered studies.
Journal Article
The transparency and reproducibility of systematic reviews in forensic science
2022
Systematic reviews are indispensable tools for both reliably informing decision-makers about the state of the field and for identifying areas that need further study. Their value, however, depends on their transparency and reproducibility. Readers should be able to determine what was searched for and when, where the authors searched, and whether that search was predetermined or evolved based on what was found. In this article, we measured the transparency and reproducibility of systematic reviews in forensic science, a field where courts, policymakers, and legislators count on systematic reviews to make informed decisions. In a sample of 100 systematic reviews published between 2018 and 2021, we found that completeness of reporting varied markedly. For instance, 50 % of reviews claimed to follow a reporting guideline and such statements were only modestly related to compliance with that reporting guideline. As to specific reporting items, 82 % reported all of the databases searched, 22 % reported the review’s full Boolean search logic, and just 7 % reported the review was registered. Among meta-analyses (n = 23), only one stated data was available and none stated the analytic code was available. After considering the results, we end with recommendations for improved regulation of reporting practices, especially among journals. Our results may serve as a useful benchmark as the field evolves.
•Systematic reviews assist decision-makers and researchers in determining what is known and unknown about a field.•We audited the transparency and reproducibility 100 forensic science systematic reviews published from 2018 to 2021.•Half of reviews purported to follow the PRISMA reporting guidelines, but these statements were only modestly related to compliance.•Transparency of reporting was uneven.•Forensic science journals should more proactively regulate the systematic reviews they publish.
Journal Article
Characteristics and completeness of reporting of systematic reviews of prevalence studies in adult populations: a metaresearch study
2024
The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, first published in 2009, has been widely endorsed and compliance is high in systematic reviews (SRs) of intervention studies. SRs of prevalence studies are increasing in frequency, but their characteristics and reporting quality have not been examined in large studies. Our objectives were to describe the characteristics of SRs of prevalence studies in adults, evaluate the completeness of reporting, and explore study-level characteristics associated with the completeness of reporting.
We did a metaresearch study. We searched 5 databases from January 2010 to December 2020 to identify SRs of prevalence studies in adult populations. We used the PRISMA 2009 checklist to assess completeness of reporting and recorded additional characteristics. We conducted a descriptive analysis of review characteristics and linear regression to assess the relationship between compliance with PRISMA and publication characteristics.
We included 1172 SRs of prevalence studies. The number of reviews increased from 25 in 2010 to 273 in 2020. The median PRISMA score for SRs without meta-analysis was 17.5 of a maximum of 23, and for SRs with meta-analysis, 22 of a maximum of 25. Completeness of reporting, particularly for key items in the methods section, was suboptimal. SRs that included a meta-analysis or reported using a reporting or conduct guideline were the factors most strongly associated with increased compliance with PRISMA 2009.
Reporting of SRs of prevalence was adequate for many PRISMA items. Nonetheless, this study highlights aspects for which special attention is needed. Development of a specific tool to assess the risk of bias in prevalence studies and an extension to the PRISMA statement could improve the conduct and reporting of SRs of prevalence studies.
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Journal Article