Reporting of Drug Trial Funding Sources and Author Financial Conflicts of Interest in Cochrane and non-Cochrane Meta-analyses: A Cross-sectional Study

Background: A previous study found that 2 of 29 (6.9%) meta-analyses published in high-impact journals in 2009 reported included drug trials’ funding sources, and none reported trial authors’ financial conflicts of interest (FCOIs) or industry employment. It is not known if reporting has improved since 2009. Our objectives were to (1) investigate the extent to which pharmaceutical industry funding and author-industry FCOIs and employment from included drug trials are reported in meta-analyses published in high-impact journals; and (2) compare current reporting with results from 2009.Methods: We searched PubMed (January 2017 – October 2018) for systematic reviews with meta-analyses including ≥ 2 randomized controlled trials (RCTs) of patented drugs. We included 3 meta-analyses published January 2017-October 2018 from each of 4 high-impact general medicine journals, high-impact journals from 5 specialty areas, and the Cochrane Database of Systematic Reviews, as in the previous study. Results: Among 29 meta-analyses reviewed, 13 of 29 (44.8%) reported the funding source of included trials compared to 2 of 29 (6.9%) in 2009, a difference of 37.9% (95% confidence interval, 15.7% to 56.3%); this included 7 of 11 (63.6%) from general medicine journals, 3 of 15 (20.0%) from specialty medicine journals, and 3 of 3 (100%) Cochrane reviews. Only 2 of 29 meta-analyses (6.9%) reported trial author FCOIs, and none reported trial author-industry employment.Protocol Publication: (https://osf.io/8xt5p/) Limitations: We examined only a relatively small number of meta-analyses from selected high-impact journals and compared results to a similarly small sample from an earlier time period.Conclusions: Reporting of drug trial sponsorship and author FCOIs in meta-analyses published in high-impact journals has increased since 2009 but is still suboptimal. Standards on reporting of trial funding described in the forthcoming revised PRISMA statement should be adapted and enforced by journals to improve reporting.

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Reporting of financial conflicts of interest in meta-analyses of drug trials published in high-impact medical journals: comparison of results from 2017 to 2018 and 2009

Systematic Reviews ◽

10.1186/s13643-020-01318-5 ◽

2020 ◽

Vol 9 (1) ◽

Cited By ~ 1

Author(s):

Carla Benea ◽

Kimberly A. Turner ◽

Michelle Roseman ◽

Lisa A. Bero ◽

Joel Lexchin ◽

...

Keyword(s):

Conflicts Of Interest ◽

High Impact ◽

Drug Trials ◽

Medical Journals ◽

Comparison Of Results ◽

Financial Conflicts Of Interest ◽

Meta Analyses

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Financial conflicts of interest among editorialists in high-impact journals

Blood Cancer Journal ◽

10.1038/bcj.2017.92 ◽

2017 ◽

Vol 7 (9) ◽

pp. e611-e611 ◽

Cited By ~ 4

Author(s):

V Kaestner ◽

V Prasad

Keyword(s):

Conflicts Of Interest ◽

High Impact ◽

Financial Conflicts Of Interest

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Conflicts of interest among authors of systematic reviews and meta-analyses investigating interventions for melanoma (Preprint)

JMIR Dermatology ◽

10.2196/25858 ◽

2020 ◽

Author(s):

Zane Rulon ◽

Kalyn Powers ◽

J. Michael Anderson ◽

Michael Weaver ◽

Austin Johnson ◽

...

Keyword(s):

Systematic Reviews ◽

Conflicts Of Interest ◽

Meta Analyses

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Usability of Mobile Health Apps for Postoperative Care: Systematic Review

JMIR Perioperative Medicine ◽

10.2196/19099 ◽

2020 ◽

Vol 3 (2) ◽

pp. e19099

Author(s):

Ben Patel ◽

Arron Thind

Keyword(s):

Systematic Review ◽

Systematic Reviews ◽

Mobile Health ◽

Conflicts Of Interest ◽

Data Extraction ◽

Measurement Tool ◽

Validated Questionnaire ◽

System Usability Scale ◽

Meta Analyses ◽

Mhealth Apps

Background Mobile health (mHealth) apps are increasingly used postoperatively to monitor, educate, and rehabilitate. The usability of mHealth apps is critical to their implementation. Objective This systematic review evaluates the (1) methodology of usability analyses, (2) domains of usability being assessed, and (3) results of usability analyses. Methods The A Measurement Tool to Assess Systematic Reviews checklist was consulted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was adhered to. Screening was undertaken by 2 independent reviewers. All included studies were assessed for risk of bias. Domains of usability were compared with the gold-standard mHealth App Usability Questionnaire (MAUQ). Results A total of 33 of 720 identified studies were included for data extraction. Of the 5 included randomized controlled trials (RCTs), usability was never the primary end point. Methodology of usability analyses included interview (10/33), self-created questionnaire (18/33), and validated questionnaire (9/33). Of the 3 domains of usability proposed in the MAUQ, satisfaction was assessed in 28 of the 33 studies, system information arrangement was assessed in 11 of the 33 studies, and usefulness was assessed in 18 of the 33 studies. Usability of mHealth apps was above industry average, with median System Usability Scale scores ranging from 76 to 95 out of 100. Conclusions Current analyses of mHealth app usability are substandard. RCTs are rare, and validated questionnaires are infrequently consulted. Of the 3 domains of usability, only satisfaction is regularly assessed. There is significant bias throughout the literature, particularly with regards to conflicts of interest. Future studies should adhere to the MAUQ to assess usability and improve the utility of mHealth apps.

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Usability of Mobile Health Apps for Postoperative Care: Systematic Review (Preprint)

10.2196/preprints.19099 ◽

2020 ◽

Author(s):

Ben Patel ◽

Arron Thind

Keyword(s):

Systematic Review ◽

Systematic Reviews ◽

Mobile Health ◽

Conflicts Of Interest ◽

Data Extraction ◽

Measurement Tool ◽

Validated Questionnaire ◽

System Usability Scale ◽

Meta Analyses ◽

Mhealth Apps

BACKGROUND Mobile health (mHealth) apps are increasingly used postoperatively to monitor, educate, and rehabilitate. The usability of mHealth apps is critical to their implementation. OBJECTIVE This systematic review evaluates the (1) methodology of usability analyses, (2) domains of usability being assessed, and (3) results of usability analyses. METHODS The A Measurement Tool to Assess Systematic Reviews checklist was consulted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was adhered to. Screening was undertaken by 2 independent reviewers. All included studies were assessed for risk of bias. Domains of usability were compared with the gold-standard mHealth App Usability Questionnaire (MAUQ). RESULTS A total of 33 of 720 identified studies were included for data extraction. Of the 5 included randomized controlled trials (RCTs), usability was never the primary end point. Methodology of usability analyses included interview (10/33), self-created questionnaire (18/33), and validated questionnaire (9/33). Of the 3 domains of usability proposed in the MAUQ, satisfaction was assessed in 28 of the 33 studies, system information arrangement was assessed in 11 of the 33 studies, and usefulness was assessed in 18 of the 33 studies. Usability of mHealth apps was above industry average, with median System Usability Scale scores ranging from 76 to 95 out of 100. CONCLUSIONS Current analyses of mHealth app usability are substandard. RCTs are rare, and validated questionnaires are infrequently consulted. Of the 3 domains of usability, only satisfaction is regularly assessed. There is significant bias throughout the literature, particularly with regards to conflicts of interest. Future studies should adhere to the MAUQ to assess usability and improve the utility of mHealth apps.

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Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design

BMC Medical Research Methodology ◽

10.1186/s12874-020-01125-5 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

E. Nury ◽

K. Bischoff ◽

K. Wollmann ◽

K. Nitschke ◽

S. Lohner ◽

...

Keyword(s):

Clinical Practice ◽

Systematic Reviews ◽

Medical Practice ◽

Research Impact ◽

Study Cohort ◽

Drug Trials ◽

Study Characteristics ◽

Investigator Initiated Trials ◽

Meta Analyses ◽

The Impact

Abstract Background The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial’s impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort. Methods The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG−/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov. Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication’s target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials. Results We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36). Conclusions The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

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Lack of Reproducibility in Addiction Medicine

10.31234/osf.io/9htca ◽

2019 ◽

Author(s):

Mopileola Tomi Adewumi ◽

Nam Vo ◽

Daniel Tritz ◽

Jason Beaman ◽

Matt Vassar

Keyword(s):

Conflicts Of Interest ◽

Data Extraction ◽

Research Integrity ◽

Data Availability ◽

Addiction Medicine ◽

Cross Sectional ◽

Funding Sources ◽

Current State ◽

Meta Analyses ◽

Substance Related Disorders

Background and aims: Credible research emphasizes transparency, openness, and reproducibility. These characteristics are fundamental to promoting and maintaining research integrity. This aim of this study was to evaluate the current state of transparency and reproducibility in the field of addiction science. Design: Cross-sectional designMeasurements: This study used the National Library of Medicine catalog to search for all journals using the subject terms tag: Substance-Related Disorders [ST]. Journals were then searched via PubMed in the timeframe of January 1, 2014 to December 31, 2018 and 300 publications were randomly selected. A pilot-tested Google form containing reproducibility/transparency characteristics was used for data extraction by two investigators who performed this process in a duplicate and blinded fashion. Findings: Slightly more than half of the publications were open access (152/293, 50.7%). Few publications had pre-registration (7/244, 2.87%), material availability (2/237, 1.23%), protocol availability (3/244 ,0.80%), data availability (28/244, 11.48%), and analysis script availability (2/244, 0.82%). Most publications provided a conflict of interest statement (221/293, 75.42%) and funding sources (268/293, 91.47%). One replication study was reported (1/244, 0.04%). Few publications were cited (64/238, 26.89%) and 0 were excluded from meta-analyses and/or systematic reviews.Conclusion: Our study found that current practices that promote transparency and reproducibility are lacking, and thus, there is much room for improvement. First, investigators should preregister studies prior to commencement. Researchers should also make the materials, data, analysis script publicly available. To foster reproducibility, individuals should remain transparent about funding sources for the project and financial conflicts of interest. Research stakeholders should work together toward improved solutions on these matters. With these protections in place, the field of addiction medicine can lead in dissemination of information necessary to treat patients.

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Is Quality and Completeness of Reporting of Systematic Reviews and Meta-Analyses Published in High Impact Radiology Journals Associated with Citation Rates?

PLoS ONE ◽

10.1371/journal.pone.0119892 ◽

2015 ◽

Vol 10 (3) ◽

pp. e0119892 ◽

Cited By ~ 24

Author(s):

Christian B. van der Pol ◽

Matthew D. F. McInnes ◽

William Petrcich ◽

Adam S. Tunis ◽

Ramez Hanna

Keyword(s):

Systematic Reviews ◽

High Impact ◽

Meta Analyses ◽

Completeness Of Reporting

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Protocol for a systematic review and meta-analysis of long-term neurocognitive outcomes in paediatric traumatic brain injury

BMJ Open ◽

10.1136/bmjopen-2019-035513 ◽

2020 ◽

Vol 10 (6) ◽

pp. e035513

Author(s):

Dawn Shu Hui Looi ◽

Mark Sen Liang Goh ◽

Sharon Si Min Goh ◽

Jia Ling Goh ◽

Rehena Sultana ◽

...

Keyword(s):

Systematic Review ◽

Traumatic Brain Injury ◽

Brain Injury ◽

Systematic Reviews ◽

Meta Analysis ◽

Small Sample ◽

Neurodevelopmental Outcomes ◽

Neurocognitive Outcomes ◽

Meta Analyses

IntroductionChildren who suffer from traumatic brain injury (TBI) are at risk of permanent brain damage and developmental deficits. Reports on neurodevelopmental outcomes in paediatric TBI suffer from small sample size and varying outcome definitions in the neurocognitive domains tested. This protocol describes a systematic review and meta-analysis of paediatric TBI in the following key neurocognitive domains: executive function, perceptual–motor function, language, learning and memory, social cognition and complex attention.MethodsA comprehensive search comprising studies from Medline, Cochrane, Embase and PsycINFO published from 1988 to 2019 will be conducted. We will include studies on children ≤18 years old who suffer from mild, moderate and severe TBI as determined by the Glasgow Coma Scale that report neurocognitive outcomes in domains predetermined by the Diagnostic and Statistical Manual of Mental Disorders fifth edition criteria. Systematic reviews, meta-analyses, randomised controlled trials, case–control, cohort and cross-sectional studies will be included. References from systematic reviews and meta-analyses will be hand-searched for relevant articles. A meta-analysis will be performed and effect sizes will be calculated to summarise the magnitude of change in each neurocognitive domain compared at different timepoints and stratified by severity of TBI. Included studies will be pooled using pooled standardised mean differences with a random effects model to determine an overall effect. In the scenario that we are unable to pool the studies, we will perform a narrative analysis.Ethics and disseminationEthics approval is not required for this study.The authors of this study will publish and present the findings in a peer-reviewed journal as well as national and international conferences. The results of this study will provide understanding into the association between different severities of paediatric TBI and long-term neurocognitive outcomes.PROSPERO registration numberCRD42020152680.

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