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Epidemiology
Protocol
Association between statistical significance and time to publication among systematic reviews: a study protocol for a meta-epidemiological investigation
  1. Yasushi Tsujimoto1,2,
  2. Yusuke Tsutsumi1,
  3. Yuki Kataoka1,
  4. Hiraku Tsujimoto3,
  5. Yosuke Yamamoto1,
  6. Davide Papola4,
  7. Gordon H Guyatt5,
  8. Shunichi Fukuhara1,
  9. Toshi A Furukawa6
  1. 1 Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan
  2. 2 Department of Nephrology and Dialysis, Kyoritsu Hospital, Kawanishi, Hyogo, Japan
  3. 3 Hospital Care Research Unit, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Hyogo, Japan
  4. 4 WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation; Department of Neuroscience, Biomedicine and Movement Sciences; Section of Psychiatry, University of Verona, Verona, Italy
  5. 5 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  6. 6 Department of Health Promotion and Human Behavior, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan
  1. Correspondence to Professor Toshi A Furukawa; furukawa{at}kuhp.kyoto-u.ac.jp

Abstract

Introduction Many studies have indicated the impact of bias in dissemination and publication in medical research. Existence of such bias among clinical trials has been repeatedly pointed out, but it has not been well studied in the field of systematic reviews (SRs). We therefore aim to investigate whether or not time lag bias and publication bias in SRs based on statistical significance in results exist. In addition, we will examine at what stage of paper publication process such bias, if any, creeps in.

Method and analysis The present study is a meta-epidemiological study. We will include all SRs of interventions registered in the international prospective register of SRs (PROSPERO) before December 2014 if the SR has completed its analysis irrespective of its publication status. All contact authors of eligible SRs will be asked to participate in a survey administered through the Internet. Our primary outcome is time from protocol registration to full publication of SR as a journal article, defined as time from the registration date to the acceptance date among all the relevant SRs. We will examine the impact of statistically significant findings on the primary outcomes through time to event analyses.

Ethics and dissemination Ethics approval will be obtained from the Ethical Committee of the Kyoto University Graduate School of Medicine. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry. We will publish our findings in a peer-reviewed journal and also may present them at conferences. Trial registration number: UMIN000028325

  • publication bias
  • time lag bias
  • systematic reviews
  • protocol registration
  • meta-epidemiological study

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/

https://doi.org/10.1136/bmjopen-2017-018856

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    Footnotes

    • Contributors YTsuj and YTsut contributed equally to this work. YTsuj, YTsut, HT, YK, YY, DP, GHG, SF and TAF contributed to the conception and design of the research. YTsuj and TAF are fully responsible for writing the protocol. TAF supervised the research, and all authors gave final approval of the protocol before submission. After the publication of the protocol, we plan the following contributions of each author: YTsuj, Ytsut, HT, YK and DP will screen the relevant records of the PROSPERO, and extract data. YTsuj, Ytsut, HT, YK, DP, GHG and TAF will contact the authors for additional information. YTsuj, Ytsut, YY and TAF will conduct the data analysis without blinding of the data. YTsuj, Ytsut and TAF will write the manuscript. GHG, SF and TAF will revise the manuscript critically for important intellectual content. TAF will supervise the research.

    • Funding This study is supported in part by JSPS KAKENHI (Grant-in-Aid for Scientific Research) Grant Number 17K19808 to TAF. The funder plays no role in developing the protocol.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.