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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MDPI AG
2021
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oai:doaj.org-article:176fe7e67383418f8dec86015a9011bb2021-11-25T16:58:37ZA Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence10.3390/brainsci111115042076-3425https://doaj.org/article/176fe7e67383418f8dec86015a9011bb2021-11-01T00:00:00Zhttps://www.mdpi.com/2076-3425/11/11/1504https://doaj.org/toc/2076-3425Traumatic 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.Meltem ElcivanAna KowarkMark CoburnHussam Aldin HamouBenedikt KremerHans ClusmannAnke HölligMDPI AGarticleTBIrandomized controlled trialCONSORT criteriamethodologyNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571ENBrain Sciences, Vol 11, Iss 1504, p 1504 (2021) |
| institution |
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| collection |
DOAJ |
| language |
EN |
| topic |
TBI randomized controlled trial CONSORT criteria methodology Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 |
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TBI randomized controlled trial CONSORT criteria methodology Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 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 |
| 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. |
| format |
article |
| 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 |
| title |
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_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_sort |
retrospective analysis of randomized controlled trials on traumatic brain injury: evaluation of consort item adherence |
| publisher |
MDPI AG |
| publishDate |
2021 |
| url |
https://doaj.org/article/176fe7e67383418f8dec86015a9011bb |
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