A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence
Traumatic brain injury (TBI) contributes to death and disability, resulting in an enormous individual and socio-economic challenges. Despite huge efforts, there are still controversies on treatment strategies and early outcome estimation. We evaluate current randomized controlled trials (RCTs) on TB...
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| Format: | Article |
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MDPI AG
2021-11-01
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| Series: | Brain Sciences |
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| Online Access: | https://www.mdpi.com/2076-3425/11/11/1504 |
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| author | Meltem Elcivan Ana Kowark Mark Coburn Hussam Aldin Hamou Benedikt Kremer Hans Clusmann Anke Höllig |
| author_facet | Meltem Elcivan Ana Kowark Mark Coburn Hussam Aldin Hamou Benedikt Kremer Hans Clusmann Anke Höllig |
| author_sort | Meltem Elcivan |
| collection | DOAJ |
| description | Traumatic brain injury (TBI) contributes to death and disability, resulting in an enormous individual and socio-economic challenges. Despite huge efforts, there are still controversies on treatment strategies and early outcome estimation. We evaluate current randomized controlled trials (RCTs) on TBI according to their fulfillment of the CONSORT (Consolidated Statement of Reporting Trials) statement’s criteria as a marker of transparency and the quality of study planning and realization. A PubMed search for RCTs on TBI (January 2014–December 2019) was carried out. After screening of the abstracts (<i>n</i> = 1.926), the suitable full text manuscripts (<i>n</i> = 72) were assessed for the fulfillment of the CONSORT criteria. The mean ratio of consort statement fulfillment was 59% (±13%), 31% of the included studies (<i>n</i> = 22) complied with less than 50% of the CONSORT criteria. Citation frequency was moderately related to ratio of CONSORT item fulfillment (<i>r</i> = 0.4877; <i>p</i> < 0.0001) and citation frequency per year (<i>r</i> = 0.5249; <i>p</i> < 0.0001). The ratio of CONSORT criteria fulfillment was associated with the impact factor of the publishing journal (<i>r</i> = 0.6428; <i>p</i> < 0.0001). Essential data for study interpretation, such as sample size determination (item 7a), participant flow (item 13a) as well as losses and exclusions (item 13b), were only reported in 53%, 60% and 63%, respectively. Reporting and methodological aspects in RCTs on TBI still may be improved. Thus, the interpretation of study results may be hampered due to methodological weaknesses. |
| first_indexed | 2024-03-10T05:39:00Z |
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| institution | Directory Open Access Journal |
| issn | 2076-3425 |
| language | English |
| last_indexed | 2024-03-10T05:39:00Z |
| publishDate | 2021-11-01 |
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| record_format | Article |
| series | Brain Sciences |
| spelling | doaj.art-176fe7e67383418f8dec86015a9011bb2023-11-22T22:38:39ZengMDPI AGBrain Sciences2076-34252021-11-011111150410.3390/brainsci11111504A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item AdherenceMeltem Elcivan0Ana Kowark1Mark Coburn2Hussam Aldin Hamou3Benedikt Kremer4Hans Clusmann5Anke Höllig6Department of Neurosurgery, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, GermanyDepartment of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, GermanyDepartment of Anaesthesiology and Intensive Care Medicine, University Hospital Bonn, Venusberg-Campus 1, D-53127 Bonn, GermanyDepartment of Neurosurgery, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, GermanyDepartment of Neurosurgery, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, GermanyDepartment of Neurosurgery, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, GermanyDepartment of Neurosurgery, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, GermanyTraumatic brain injury (TBI) contributes to death and disability, resulting in an enormous individual and socio-economic challenges. Despite huge efforts, there are still controversies on treatment strategies and early outcome estimation. We evaluate current randomized controlled trials (RCTs) on TBI according to their fulfillment of the CONSORT (Consolidated Statement of Reporting Trials) statement’s criteria as a marker of transparency and the quality of study planning and realization. A PubMed search for RCTs on TBI (January 2014–December 2019) was carried out. After screening of the abstracts (<i>n</i> = 1.926), the suitable full text manuscripts (<i>n</i> = 72) were assessed for the fulfillment of the CONSORT criteria. The mean ratio of consort statement fulfillment was 59% (±13%), 31% of the included studies (<i>n</i> = 22) complied with less than 50% of the CONSORT criteria. Citation frequency was moderately related to ratio of CONSORT item fulfillment (<i>r</i> = 0.4877; <i>p</i> < 0.0001) and citation frequency per year (<i>r</i> = 0.5249; <i>p</i> < 0.0001). The ratio of CONSORT criteria fulfillment was associated with the impact factor of the publishing journal (<i>r</i> = 0.6428; <i>p</i> < 0.0001). Essential data for study interpretation, such as sample size determination (item 7a), participant flow (item 13a) as well as losses and exclusions (item 13b), were only reported in 53%, 60% and 63%, respectively. Reporting and methodological aspects in RCTs on TBI still may be improved. Thus, the interpretation of study results may be hampered due to methodological weaknesses.https://www.mdpi.com/2076-3425/11/11/1504TBIrandomized controlled trialCONSORT criteriamethodology |
| spellingShingle | Meltem Elcivan Ana Kowark Mark Coburn Hussam Aldin Hamou Benedikt Kremer Hans Clusmann Anke Höllig A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence Brain Sciences TBI randomized controlled trial CONSORT criteria methodology |
| title | A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence |
| title_full | A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence |
| title_fullStr | A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence |
| title_full_unstemmed | A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence |
| title_short | A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence |
| title_sort | retrospective analysis of randomized controlled trials on traumatic brain injury evaluation of consort item adherence |
| topic | TBI randomized controlled trial CONSORT criteria methodology |
| url | https://www.mdpi.com/2076-3425/11/11/1504 |
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