PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia
Introduction Traumatic brain injury (TBI) is a heterogeneous condition in terms of pathophysiology and clinical course. Outcomes from moderate to severe TBI (msTBI) remain poor despite concerted research efforts. The heterogeneity of clinical management represents a barrier to progress in this area....
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BMJ Publishing Group
2024-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/2/e080614.full |
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| author | Belinda J Gabbe Rinaldo Bellomo Terence J O'Brien Andrew Chow Anthony Delaney Michael Reade Anthony Trapani Andrew Udy Melinda Fitzgerald James Anstey David Bowen D James Cooper Judith Bellapart Toby Jeffcote Camila R Battistuzzo Mark P Plummer Robert McNamara Rebecca Roach Torgeir Westerlund Shailesh Bihari Mark Weeden Rosalind L Jeffree Alistair D Nichol |
| author_facet | Belinda J Gabbe Rinaldo Bellomo Terence J O'Brien Andrew Chow Anthony Delaney Michael Reade Anthony Trapani Andrew Udy Melinda Fitzgerald James Anstey David Bowen D James Cooper Judith Bellapart Toby Jeffcote Camila R Battistuzzo Mark P Plummer Robert McNamara Rebecca Roach Torgeir Westerlund Shailesh Bihari Mark Weeden Rosalind L Jeffree Alistair D Nichol |
| author_sort | Belinda J Gabbe |
| collection | DOAJ |
| description | Introduction Traumatic brain injury (TBI) is a heterogeneous condition in terms of pathophysiology and clinical course. Outcomes from moderate to severe TBI (msTBI) remain poor despite concerted research efforts. The heterogeneity of clinical management represents a barrier to progress in this area. PRECISION-TBI is a prospective, observational, cohort study that will establish a clinical research network across major neurotrauma centres in Australia. This network will enable the ongoing collection of injury and clinical management data from patients with msTBI, to quantify variations in processes of care between sites. It will also pilot high-frequency data collection and analysis techniques, novel clinical interventions, and comparative effectiveness methodology.Methods and analysis PRECISION-TBI will initially enrol 300 patients with msTBI with Glasgow Coma Scale (GCS) <13 requiring intensive care unit (ICU) admission for invasive neuromonitoring from 10 Australian neurotrauma centres. Demographic data and process of care data (eg, prehospital, emergency and surgical intervention variables) will be collected. Clinical data will include prehospital and emergency department vital signs, and ICU physiological variables in the form of high frequency neuromonitoring data. ICU treatment data will also be collected for specific aspects of msTBI care. Six-month extended Glasgow Outcome Scores (GOSE) will be collected as the key outcome. Statistical analysis will focus on measures of between and within-site variation. Reports documenting performance on selected key quality indicators will be provided to participating sites.Ethics and dissemination Ethics approval has been obtained from The Alfred Human Research Ethics Committee (Alfred Health, Melbourne, Australia). All eligible participants will be included in the study under a waiver of consent (hospital data collection) and opt-out (6 months follow-up). Brochures explaining the rationale of the study will be provided to all participants and/or an appropriate medical treatment decision-maker, who can act on the patient’s behalf if they lack capacity. Study findings will be disseminated by peer-review publications.Trial registration number NCT05855252. |
| format | Article |
| id | doaj-art-d0cdb3e08d4149ddbf9aff401c978e71 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d0cdb3e08d4149ddbf9aff401c978e712025-08-20T02:51:18ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-080614PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in AustraliaBelinda J Gabbe0Rinaldo Bellomo1Terence J O'Brien2Andrew Chow3Anthony Delaney4Michael Reade5Anthony Trapani6Andrew Udy7Melinda Fitzgerald8James Anstey9David Bowen10D James Cooper11Judith Bellapart12Toby Jeffcote13Camila R Battistuzzo14Mark P Plummer15Robert McNamara16Rebecca Roach17Torgeir Westerlund18Shailesh Bihari19Mark Weeden20Rosalind L Jeffree21Alistair D Nichol223 Population Data Science, Swansea University Medical School, Faculty of Medicine, Health & Life Science, Swansea University, Swansea, UKDepartment of Intensive Care, Austin Health, Heidelberg, Victoria, Australia3 Department of Medicine, Royal Melbourne Hospital, The University of Melbourne, Melbourne, Victoria, AustraliaUniversity of Toronto, Toronto, CanadaThe George Institute for Global Health, Sydney, New South Wales, AustraliaDepartment of Intensive Care Medicine, Royal Brisbane and Women`s Hospital, Brisbane, Queensland, AustraliaAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, AustraliaAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, AustraliaCurtin Health Innovation Research Institute, Curtin University Faculty of Health Sciences, Perth, Western Australia, AustraliaDepartment of Intensive Care, The Royal Melbourne Hospital, Melbourne, Victoria, AustraliaWestmead Hospital, Sydney, New South Wales, AustraliaAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, AustraliaRoyal Brisbane and Women’s Hospital, Brisbane, Queensland, AustraliaDepartment of Intensive Care, The Alfred Hospital, Melbourne, Victoria, AustraliaAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, AustraliaDepartment of Intensive Care, Royal Adelaide Hospital, Adelaide, South Australia, AustraliaDepartment of Intensive Care Medicine, Royal Perth Hospital, Perth, Western Australia, AustraliaDepartment of Intensive Care, The Alfred Hospital, Melbourne, Victoria, AustraliaDepartment of Intensive Care Medicine, John Hunter Hospital, Newcastle, New South Wales, AustraliaFlinders Medical Centre, Bedford Park, South Australia, AustraliaIntensive Care Unit, St George Hospital, Sydney, New South Wales, AustraliaFaculty of Medicine, Medical School, University of Queensland, Brisbane, Queensland, AustraliaDepartment of Intensive Care, The Alfred Hospital, Melbourne, Victoria, AustraliaIntroduction Traumatic brain injury (TBI) is a heterogeneous condition in terms of pathophysiology and clinical course. Outcomes from moderate to severe TBI (msTBI) remain poor despite concerted research efforts. The heterogeneity of clinical management represents a barrier to progress in this area. PRECISION-TBI is a prospective, observational, cohort study that will establish a clinical research network across major neurotrauma centres in Australia. This network will enable the ongoing collection of injury and clinical management data from patients with msTBI, to quantify variations in processes of care between sites. It will also pilot high-frequency data collection and analysis techniques, novel clinical interventions, and comparative effectiveness methodology.Methods and analysis PRECISION-TBI will initially enrol 300 patients with msTBI with Glasgow Coma Scale (GCS) <13 requiring intensive care unit (ICU) admission for invasive neuromonitoring from 10 Australian neurotrauma centres. Demographic data and process of care data (eg, prehospital, emergency and surgical intervention variables) will be collected. Clinical data will include prehospital and emergency department vital signs, and ICU physiological variables in the form of high frequency neuromonitoring data. ICU treatment data will also be collected for specific aspects of msTBI care. Six-month extended Glasgow Outcome Scores (GOSE) will be collected as the key outcome. Statistical analysis will focus on measures of between and within-site variation. Reports documenting performance on selected key quality indicators will be provided to participating sites.Ethics and dissemination Ethics approval has been obtained from The Alfred Human Research Ethics Committee (Alfred Health, Melbourne, Australia). All eligible participants will be included in the study under a waiver of consent (hospital data collection) and opt-out (6 months follow-up). Brochures explaining the rationale of the study will be provided to all participants and/or an appropriate medical treatment decision-maker, who can act on the patient’s behalf if they lack capacity. Study findings will be disseminated by peer-review publications.Trial registration number NCT05855252.https://bmjopen.bmj.com/content/14/2/e080614.full |
| spellingShingle | Belinda J Gabbe Rinaldo Bellomo Terence J O'Brien Andrew Chow Anthony Delaney Michael Reade Anthony Trapani Andrew Udy Melinda Fitzgerald James Anstey David Bowen D James Cooper Judith Bellapart Toby Jeffcote Camila R Battistuzzo Mark P Plummer Robert McNamara Rebecca Roach Torgeir Westerlund Shailesh Bihari Mark Weeden Rosalind L Jeffree Alistair D Nichol PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia BMJ Open |
| title | PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia |
| title_full | PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia |
| title_fullStr | PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia |
| title_full_unstemmed | PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia |
| title_short | PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia |
| title_sort | precision tbi a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in australia |
| url | https://bmjopen.bmj.com/content/14/2/e080614.full |
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