Randomized Controlled Trials on Intracerebral Hemorrhage: A Cross Sectional Retrospective Analysis of CONSORT Item Adherence

Kirstin Jauch; Ana Kowark; Mark Coburn; Hans Clusmann; Anke Höllig

doi:10.3389/fneur.2019.00991

Randomized Controlled Trials on Intracerebral Hemorrhage: A Cross Sectional Retrospective Analysis of CONSORT Item Adherence

Front Neurol. 2019 Sep 20:10:991. doi: 10.3389/fneur.2019.00991. eCollection 2019.

Authors

Kirstin Jauch¹, Ana Kowark², Mark Coburn², Hans Clusmann¹, Anke Höllig¹

Affiliations

¹ Department of Neurosurgery, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.
² Department of Anaesthesiology, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.

Abstract

Object: Intracranial hemorrhage (ICH) is the second most common cause of stroke but still there is little consolidated knowledge about the optimal treatment strategies (e.g., the benefit of surgical evacuation). We evaluated the current randomized controlled trials (RCTs) on primary ICH (01.2013-03.2017) according to their fulfillment of the CONSORT statement's criteria (published in 2010) -as a marker of transparency and quality of study planning and realization. Methods: A Pubmed and a Cochrane database (including clinicaltrials.gov) search was carried out (01.2014-3.2017, respectively 01.2013-12.2013). Abstracts were screened for inclusion. Eligible full text manuscripts were assessed for the implementation of the CONSORT criteria. Citation frequencies and impact factors of the journals were related to ratio of CONSORT criteria fulfillment. Further, the risk of bias according to the Risk of bias tool 2 (RoB 2) was assessed. Results: Overall 3097 abstracts were screened for inclusion; 39 studies were suitable for final analysis. A mean fulfillment ratio of 51% (±28%) was found. A high correlation between impact factor and adherence to CONSORT criteria was shown (r = 0.7664; p < 0.0001). Citation frequency per year was related to ratio of CONSORT item fulfillment (r = 0.6747; p < 0.0001) and to the impact factor of the publishing journal (r = 0.7310; p < 0.0001). Of note, the items 10 (randomization: implementation) and 21 (generalizability) showed particularly high rates of non-fulfillment (87 and 85%). The majority of studies (95%) complied with item 2b (specific objectives or hypotheses), but strikingly objectives were mostly described vaguely. Other essential criteria such as sample size determination, definition of outcome parameters, and participant flow were only fulfilled weakly (51, 54, and 39%). Conclusions: Over 20 years after its inception there is still weak adherence to the CONSORT statement. As a consequence, conclusions are hampered by inadequate planning and/or reporting. Particularly with respect to pathologies as ICH lacking clear, evidence-based guidelines adherence to the CONSORT statement might improve research quality in order to define valuable treatment strategies.

Keywords: CONSORT statement; hemorrhagic stroke; intracerebral hemorrhage; randomized controlled trials; transparent reporting.