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). s 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.
Highlights
Intracranial hemorrhage (ICH) is the second most common cause of stroke; the overall global burden of hemorrhagic stroke (ICH and subarachnoid hemorrhage) including deaths and DALYs is higher than in ischemic stroke, ischemic stroke accounts for nearly twice as much number of incidents [1, 2]
The DALYs lost due to hemorrhagic stroke are almost twice as high than those lost due to ischemic stroke (62,842,896 vs. 39,389,408 years, data for 2010) [1]
Data on surgical treatment are conflicting: There is no consensus on the question which subgroup of patients benefits from a surgical intervention, if there is a benefit
Summary
Intracranial hemorrhage (ICH) is the second most common cause of stroke; the overall global burden of hemorrhagic stroke (ICH and subarachnoid hemorrhage) including deaths and DALYs (disability-adjusted life years) is higher than in ischemic stroke, ischemic stroke accounts for nearly twice as much number of incidents [1, 2]. The DALYs lost due to hemorrhagic stroke are almost twice as high than those lost due to ischemic stroke (62,842,896 vs 39,389,408 years, data for 2010) [1]. Even the large STICH trials [3, 4] were not able to clarify this subgroup sufficiently and the conclusions especially drawn from the STICH trials are still debated controversially [5,6,7]
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