Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in  The BMJ  and  PLOS Medicine

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Objectives

To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in journals with a full data sharing policy and to describe potential difficulties encountered in the process of performing reanalyses of the primary outcomes.

Design

Survey of published RCTs.

Setting

PubMed/Medline.

Eligibility criteria

RCTs that had been submitted and published by The BMJ and PLOS Medicine subsequent to the adoption of data sharing policies by these journals.

Main outcome measure

The primary outcome was data availability, defined as the eventual receipt of complete data with clear labelling. Primary outcomes were reanalyzed to assess to what extent studies were reproduced. Difficulties encountered were described.

Results

37 RCTs (21 from The BMJ and 16 from PLOS Medicine) published between 2013 and 2016 met the eligibility criteria. 17/37 (46%, 95% confidence interval 30% to 62%) satisfied the definition of data availability and 14 of the 17 (82%, 59% to 94%) were fully reproduced on all their primary outcomes. Of the remaining RCTs, errors were identified in two but reached similar conclusions and one paper did not provide enough information in the Methods section to reproduce the analyses. Difficulties identified included problems in contacting corresponding authors and lack of resources on their behalf in preparing the datasets. In addition, there was a range of different data sharing practices across study groups.

Conclusions

Data availability was not optimal in two journals with a strong policy for data sharing. When investigators shared data, most reanalyses largely reproduced the original results. Data sharing practices need to become more widespread and streamlined to allow meaningful reanalyses and reuse of data.

Trial registration

Open Science Framework osf.io/c4zke.

Related collections

Most cited references 35

Record: found
Abstract: found
Article: found

Is Open Access

Badges to Acknowledge Open Practices: A Simple, Low-Cost, Effective Method for Increasing Transparency

Mallory Kidwell, Ljiljana Lazarević, Erica Baranski … (2016)

Beginning January 2014, Psychological Science gave authors the opportunity to signal open data and materials if they qualified for badges that accompanied published articles. Before badges, less than 3% of Psychological Science articles reported open data. After badges, 23% reported open data, with an accelerating trend; 39% reported open data in the first half of 2015, an increase of more than an order of magnitude from baseline. There was no change over time in the low rates of data sharing among comparison journals. Moreover, reporting openness does not guarantee openness. When badges were earned, reportedly available data were more likely to be actually available, correct, usable, and complete than when badges were not earned. Open materials also increased to a weaker degree, and there was more variability among comparison journals. Badges are simple, effective signals to promote open practices and improve preservation of data and materials by using independent repositories.

1 comments Cited 221 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Epidemiology and reporting of randomised trials published in PubMed journals.

An-Wen Chan, Douglas G. Altman (2015)

Although randomised trials are important for evidence-based medicine, little is known about their overall characteristics. We assessed the epidemiology and reporting of methodological details for all 519 PubMed-indexed randomised trials published in December, 2000 (383 [74%] parallel-group, 116 [22%] crossover). 482 (93%) were published in specialty journals. A median of 80 participants (10th-90th percentile 25-369) were recruited for parallel-group trials. 309 (60%) were blinded. Power calculation, primary outcomes, random sequence generation, allocation concealment, and handling of attrition were each adequately described in less than half of publications. The small sample sizes are worrying, and poor reporting of methodological characteristics will prevent reliable quality assessment of many published trials.

0 comments Cited 152 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

Strategies for Understanding and Reducing the Plasmodium vivax and Plasmodium ovale Hypnozoite Reservoir in Papua New Guinean Children: A Randomised Placebo-Controlled Trial and Mathematical Model

Leanne J Robinson, Rahel Wampfler, Inoni Betuela … (2015)

Background The undetectable hypnozoite reservoir for relapsing Plasmodium vivax and P. ovale malarias presents a major challenge for malaria control and elimination in endemic countries. This study aims to directly determine the contribution of relapses to the burden of P. vivax and P. ovale infection, illness, and transmission in Papua New Guinean children. Methods and Findings From 17 August 2009 to 20 May 2010, 524 children aged 5–10 y from East Sepik Province in Papua New Guinea (PNG) participated in a randomised double-blind placebo-controlled trial of blood- plus liver-stage drugs (chloroquine [CQ], 3 d; artemether-lumefantrine [AL], 3 d; and primaquine [PQ], 20 d, 10 mg/kg total dose) (261 children) or blood-stage drugs only (CQ, 3 d; AL, 3 d; and placebo [PL], 20 d) (263 children). Participants, study staff, and investigators were blinded to the treatment allocation. Twenty children were excluded during the treatment phase (PQ arm: 14, PL arm: 6), and 504 were followed actively for 9 mo. During the follow-up time, 18 children (PQ arm: 7, PL arm: 11) were lost to follow-up. Main primary and secondary outcome measures were time to first P. vivax infection (by qPCR), time to first clinical episode, force of infection, gametocyte positivity, and time to first P. ovale infection (by PCR). A basic stochastic transmission model was developed to estimate the potential effect of mass drug administration (MDA) for the prevention of recurrent P. vivax infections. Targeting hypnozoites through PQ treatment reduced the risk of having at least one qPCR-detectable P. vivax or P. ovale infection during 8 mo of follow-up (P. vivax: PQ arm 0.63/y versus PL arm 2.62/y, HR = 0.18 [95% CI 0.14, 0.25], p < 0.001; P. ovale: 0.06 versus 0.14, HR = 0.31 [95% CI 0.13, 0.77], p = 0.011) and the risk of having at least one clinical P. vivax episode (HR = 0.25 [95% CI 0.11, 0.61], p = 0.002). PQ also reduced the molecular force of P. vivax blood-stage infection in the first 3 mo of follow-up (PQ arm 1.90/y versus PL arm 7.75/y, incidence rate ratio [IRR] = 0.21 [95% CI 0.15, 0.28], p < 0.001). Children who received PQ were less likely to carry P. vivax gametocytes (IRR = 0.27 [95% CI 0.19, 0.38], p < 0.001). PQ had a comparable effect irrespective of the presence of P. vivax blood-stage infection at the time of treatment (p = 0.14). Modelling revealed that mass screening and treatment with highly sensitive quantitative real-time PCR, or MDA with blood-stage treatment alone, would have only a transient effect on P. vivax transmission levels, while MDA that includes liver-stage treatment is predicted to be a highly effective strategy for P. vivax elimination. The inclusion of a directly observed 20-d treatment regime maximises the efficiency of hypnozoite clearance but limits the generalisability of results to real-world MDA programmes. Conclusions These results suggest that relapses cause approximately four of every five P. vivax infections and at least three of every five P. ovale infections in PNG children and are important in sustaining transmission. MDA campaigns combining blood- and liver-stage treatment are predicted to be a highly efficacious intervention for reducing P. vivax and P. ovale transmission. Trial registration ClinicalTrials.gov NCT02143934

0 comments Cited 146 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Florian Naudet: Role: postdoctoral fellow

Charlotte Sakarovitch: Role: senior statistician

Perrine Janiaud: Role: postdoctoral fellow

Ioana Cristea: Role: visiting scholar

Daniele Fanelli: Role: senior scientist

David Moher: Role: visiting scholar

John P A Ioannidis: Role: professor

Journal

Journal ID (nlm-ta): BMJ

Journal ID (iso-abbrev): BMJ

Journal ID (publisher-id): BMJ-US

Journal ID (hwp): bmj

Title: The BMJ

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1756-1833

Publication date Collection: 2018

Publication date (Electronic): 13 February 2018

Volume: 360

Electronic Location Identifier: k400

Affiliations

[1 ]Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA

[2 ]Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA, USA

[3 ]Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Romania

[4 ]Department of Methodology, London School of Economics and Political Science, UK

[5 ]Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada

[6 ]Departments of Medicine, of Health Research and Policy, of Biomedical Data Science, and of Statistics, Stanford University, Stanford, California, USA

Author notes

Correspondence to: J P A Ioannidis jioannid@ 123456stanford.edu

Article

Publisher ID: nauf041198

DOI: 10.1136/bmj.k400

PMC ID: 5809812

PubMed ID: 29440066

SO-VID: 37984eed-e3b4-42cc-8b3a-3c7d0147b0ad

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine

Read this article at

Abstract

Objectives

Design

Setting

Eligibility criteria

Main outcome measure

Results

Conclusions

Trial registration

Related collections

Karger: Coronavirus / COVID-19

Most cited references 35

Badges to Acknowledge Open Practices: A Simple, Low-Cost, Effective Method for Increasing Transparency

Epidemiology and reporting of randomised trials published in PubMed journals.

Strategies for Understanding and Reducing the Plasmodium vivax and Plasmodium ovale Hypnozoite Reservoir in Papua New Guinean Children: A Randomised Placebo-Controlled Trial and Mathematical Model

Author and article information

Contributors

Journal

Affiliations

Author notes

Article

History

Categories

Comments

Comment on this article

Similar content 335

Cited by 73