Article type
Year
Abstract
Background: Non-publication of clinical trial results may decisively reduce the benefit of systematic reviews. Because the results from the research that is available differ from the results of all the research that has been completed in an area, this may lead to wrong conclusions about benefits and harms of medical interventions. As awareness has grown about the problem of publication bias, preventive measures have been implemented—but without much success.
Objectives: To identify factors acting as barriers or facilitators in the implementation of interventions to prevent publication bias.
Methods: We chose two qualitative approaches to identify influencing factors: A thematic analysis of 42 articles identified through a literature search inMEDLINE, the Cochrane Library, EMBASE, CINAHL, PsycINFO, AMED, Web of Science and a hand search (Fig. 1) and 33 semi-structured interviews with different stakeholders. We focused on the following interventions to overcome publication bias: (1) prospective trial registration; (2) peer review; (3) open access policies; (4) monitoring of ethics committees and funding agencies on the publication of trial results; and (5) conflict of interest statements.
Results: We identified 22 barriers and 14 facilitators. Competing interests of different stakeholder groups and reluctance to publish sensitive data or negative results were identified as main barriers, as well as lack of provided resources, mechanisms to enforce the proper implementation of these interventions, and lack of awareness of the problem of publication bias. Facilitators include international harmonization of prospective trial registration and raising awareness of publication bias among the scientific community. The results of the interviews will be available at the end of May.
Conclusions: Given the plurality of barriers, it will not be enough to count on the voluntariness of stakeholders to make sure that interventions to prevent publication bias are implemented. Therefore the implementation of these interventions should be mandatory and enforcement mechanisms should be installed.
Objectives: To identify factors acting as barriers or facilitators in the implementation of interventions to prevent publication bias.
Methods: We chose two qualitative approaches to identify influencing factors: A thematic analysis of 42 articles identified through a literature search inMEDLINE, the Cochrane Library, EMBASE, CINAHL, PsycINFO, AMED, Web of Science and a hand search (Fig. 1) and 33 semi-structured interviews with different stakeholders. We focused on the following interventions to overcome publication bias: (1) prospective trial registration; (2) peer review; (3) open access policies; (4) monitoring of ethics committees and funding agencies on the publication of trial results; and (5) conflict of interest statements.
Results: We identified 22 barriers and 14 facilitators. Competing interests of different stakeholder groups and reluctance to publish sensitive data or negative results were identified as main barriers, as well as lack of provided resources, mechanisms to enforce the proper implementation of these interventions, and lack of awareness of the problem of publication bias. Facilitators include international harmonization of prospective trial registration and raising awareness of publication bias among the scientific community. The results of the interviews will be available at the end of May.
Conclusions: Given the plurality of barriers, it will not be enough to count on the voluntariness of stakeholders to make sure that interventions to prevent publication bias are implemented. Therefore the implementation of these interventions should be mandatory and enforcement mechanisms should be installed.
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