TY - JOUR
T1 - Protocol for a systematic review on the extent of non-publication of research studies and associated study characteristics.
AU - Portalupi, Susan
AU - von Elm, Erik
AU - Schmucker, Christine
AU - Lang, Britta
AU - Motschall, Edith
AU - Schwarzer, Guido
AU - Gross, Isabel T.
AU - Scherer, Roberta W.
AU - Bassler, Dirk
AU - Meerpohl, Joerg J.
AU - OPEN Consortium, Consortium
N1 - Funding Information:
In response to these concerns the OPEN Project (To Overcome failure to Publish nEgative fiNdings) was developed with the goal of elucidating the scope of nonpublication of studies. The OPEN Project is a 24-month project co-funded by the European Commission under the Seventh Framework Programme. With an international work group composed of key opinion leaders (for detailed information see Appendix), the project will first examine the current evidence on publication bias through a series of systematic reviews such as the one described in this protocol. Second, the OPEN Project will examine current practices by key groups in the field of biomedical research (namely funding agencies, the (pharmaceutical) industry, research ethics committees, research institutions, researchers, trial registries, biomedical journals, regulatory agencies, and benefit assessment agencies), through surveys, interviews, and analysis of current policies and guidelines. These findings will be presented and discussed during an international workshop, which aims to develop recommendations for implementing effective measures to avoid non-publication of studies and related publication bias at all levels.
Funding Information:
We thank Patrick Oeller and Laura Cabrera for their input during development and piloting of our data extraction form. The OPEN Project (www.open-project.eu) is funded by the European Union Seventh Framework Programme (FP7 – HEALTH.2011.4.1-2) under grant agreement n° 285453.
PY - 2013
Y1 - 2013
N2 - Methodological research has found that non-published studies often have different results than those that are published, a phenomenon known as publication bias. When results are not published, or are published selectively based on the direction or the strength of the findings, healthcare professionals and consumers of healthcare cannot base their decision-making on the full body of current evidence. As part of the OPEN project (http://www.open-project.eu) we will conduct a systematic review with the following objectives:1. To determine the proportion and/or rate of non-publication of studies by systematically reviewing methodological research projects that followed up a cohort of studies that a. received research ethics committee (REC) approval,b. were registered in trial registries, orc. were presented as abstracts at conferences.2. To assess the association of study characteristics (for example, direction and/or strength of findings) with likelihood of full publication.To identify reports of relevant methodological research projects we will conduct electronic database searches, check reference lists, and contact experts. Published and unpublished projects will be included. The inclusion criteria are as follows:a. RECs: methodological research projects that examined the subsequent proportion and/or rate of publication of studies that received approval from RECs;b. Trial registries: methodological research projects that examine the subsequent proportion and/or rate of publication of studies registered in trial registries;c. Conference abstracts: methodological research projects that examine the subsequent proportion and/or rate of full publication of studies which were initially presented at conferences as abstracts.Primary outcomes: Proportion/rate of published studies; time to full publication (mean/median; cumulative publication rate by time).Secondary outcomes: Association of study characteristics with full publication.The different questions (a, b, and c) will be investigated separately. Data synthesis will involve a combination of descriptive and statistical summaries of the included methodological research projects. Results are expected to be publicly available in mid 2013.
AB - Methodological research has found that non-published studies often have different results than those that are published, a phenomenon known as publication bias. When results are not published, or are published selectively based on the direction or the strength of the findings, healthcare professionals and consumers of healthcare cannot base their decision-making on the full body of current evidence. As part of the OPEN project (http://www.open-project.eu) we will conduct a systematic review with the following objectives:1. To determine the proportion and/or rate of non-publication of studies by systematically reviewing methodological research projects that followed up a cohort of studies that a. received research ethics committee (REC) approval,b. were registered in trial registries, orc. were presented as abstracts at conferences.2. To assess the association of study characteristics (for example, direction and/or strength of findings) with likelihood of full publication.To identify reports of relevant methodological research projects we will conduct electronic database searches, check reference lists, and contact experts. Published and unpublished projects will be included. The inclusion criteria are as follows:a. RECs: methodological research projects that examined the subsequent proportion and/or rate of publication of studies that received approval from RECs;b. Trial registries: methodological research projects that examine the subsequent proportion and/or rate of publication of studies registered in trial registries;c. Conference abstracts: methodological research projects that examine the subsequent proportion and/or rate of full publication of studies which were initially presented at conferences as abstracts.Primary outcomes: Proportion/rate of published studies; time to full publication (mean/median; cumulative publication rate by time).Secondary outcomes: Association of study characteristics with full publication.The different questions (a, b, and c) will be investigated separately. Data synthesis will involve a combination of descriptive and statistical summaries of the included methodological research projects. Results are expected to be publicly available in mid 2013.
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U2 - 10.1186/2046-4053-2-2
DO - 10.1186/2046-4053-2-2
M3 - Article
C2 - 23302739
AN - SCOPUS:84878081622
SN - 0309-1708
VL - 2
SP - 2
JO - Unknown Journal
JF - Unknown Journal
M1 - 2
ER -