Call to participate in the international study of traumatic brain injury results (Global Neurotrauma Outcomes Study)

Panero Pérez, Irene; Castaño León, Ana-María; Gandía González, María Luisa; Kolias, Angelos

doi:10.1016/j.neucie.2018.11.003

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"identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "María Luisa" "apellidos" => "Gandía González" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 3 => array:3 [ "nombre" => "Angelos" "apellidos" => "Kolias" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Departamento de Neurocirugía, Hospital Universitario 12 de Octubre, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Departamento de Neurocirugía, Hospital Universitario La Paz, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Departamento de Neurocirugía, Addenbrooke's Hospital, Cambridge, United Kingdom" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Llamada para participar en el estudio internacional de resultados del traumatismo craneoencefálico (Global Neurotrauma Outcomes Study)" ] ] "textoCompleto" => "BackgroundAccording to the epidemiological studies published to date, an estimated 69 million people suffer a traumatic brain injury (TBI) worldwide every year, most of which will be mild (81%) or moderate (11%), with only 8% constituting a severe TBI. Although there are varying definitions of TBI among different studies and epidemiological differences in different geographical areas, the global incidence of TBI is considered to be 200 cases per 100,000 population/year. TBI causes a significant number of deaths and disability worldwide. It is responsible for approximately 5 million deaths per year, representing 9% of the total global mortality.<a class="elsevierStyleCrossRef" href="#bib0050">1</a> The World Health Organization (WHO) estimates that almost 90% of injury-related deaths occur in low- and middle-income countries, where 85% of the world's population lives. Of these injury-related deaths, TBI is responsible in 30–50% of cases, making it the main cause, while also representing the leading cause of death and disability worldwide among all trauma-related injuries.<a class="elsevierStyleCrossRefs" href="#bib0055">2,3</a> Hospital mortality following a TBI is also known to be significantly higher in low- and middle-income countries versus their high income counterparts.<a class="elsevierStyleCrossRef" href="#bib0065">4</a> Significant differences have been described in patient management protocols following a TBI based on geographical area and, on occasions, these variations have impacted patients’ prognoses. According to previous studies, epidemiological estimates and TBI management in low- and middle-income countries are limited. More effort is thus required in order to record reliable epidemiological data on the incidence, management and prognosis of patients with TBIs in these types of environment with scant resources.<a class="elsevierStyleCrossRef" href="#bib0050">1</a>In accordance with the United States’ National Trauma Data Bank, 3.6% of all patients with a head injury require surgical intervention,<a class="elsevierStyleCrossRef" href="#bib0070">5</a> but this value is significantly higher in patients with a severe TBI, with worse outcomes in this particular patient group.<a class="elsevierStyleCrossRef" href="#bib0075">6</a> It is widely recognised that the early evacuation of an intracranial haematoma dramatically improves outcomes. However, the Lancet Commission on Global Surgery estimates that 5 billion people worldwide lack access to surgical care, including neurosurgical interventions.<a class="elsevierStyleCrossRef" href="#bib0080">7</a>ObjectiveIn this context, the Global Neurotrauma Outcomes Study (GNOS) is the first global neurosurgical study which aims to provide a full and global picture of the management and outcomes of patients who have undergone emergency surgery due to TBI, comparing outcomes between countries with a high and low Human Development Index (HDI).Study designThe GNOS is a multicentre, international, prospective cohort study, which will be carried out by a team of principal investigators from the National Institute for Health Research (NIHR) Global Health Research Group from the United Kingdom, Africa, Asia and South America.The study has the support of the World Federation of Neurological Surgeons (WFNS). Funding for the administrative costs of this study is provided by the NIHR Global Health Research Group on Neurotrauma.The study involves a working methodology that combines surgeons from different hospitals (multicentre study) working together to compile data in a prospective manner. This type of methodology has been used successfully in the past. Resident surgeons have accordingly played a key role in previous studies (<a id="intr0010" class="elsevierStyleInterRef" href="https://www.ncbi.nlm.nih.gov/pubmed/25584384">https://www.ncbi.nlm.nih.gov/pubmed/25584384</a>).<a class="elsevierStyleCrossRef" href="#bib0085">8</a> In the neurosurgery setting, the British Neurosurgical Trainee Research Collaborative has brought together neurosurgery residents from all over the United Kingdom and successfully completed various observational studies (<a id="intr0015" class="elsevierStyleInterRef" href="https://www.ncbi.nlm.nih.gov/pubmed/29101466">https://www.ncbi.nlm.nih.gov/pubmed/29101466</a>).<a class="elsevierStyleCrossRef" href="#bib0090">9</a> In general surgery, the international working group GlobalSurg has gathered every continent, successfully enrolling 23,000 patients in its first two studies (<a id="intr0020" class="elsevierStyleInterRef" href="http://globalsurg.org/">http://globalsurg.org</a>). The methodology adopted in the GNOS is similar to the one used in these studies.MethodsInclusion period and study durationBetween 1 October 2018 and 1 April 2019, all patients undergoing emergency surgery for a TBI in the first 30 days after the accident will be included.A 30-day period will be chosen in between these dates for data collection. As of the surgery date, the teams must monitor patients for 14 days or until they are discharged or die, whichever occurs first.Site inclusion criteriaAny hospital or clinic where emergency surgery is performed on patients who have presented with a TBI may take part.Development of a local teamThe neurosurgeons at each participating unit will form a study team, which will be responsible for gaining the local approval of the research committee at the study team's institution, as well as for identifying patients and conducting data collection.The local study team will comprise a principal investigator and up to two additional members who will help him/her to collect all the data, as well as an independent reviewer who ensures that the data collected are correct. These will be cited on PubMed as collaborator status authors on all publications resulting from the study. Similarly, once the study is complete, they may request access to the entire data set or a subset thereof in order to perform post hoc analysis which enables them to answer any study-specific questions.Patient inclusion criteriaAdult and paediatric patients admitted to the site following a TBI who require emergency surgery for intracranial lesions in the first 30 days after admission.Exclusion criteria<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">-Patients who only have a device inserted for the diagnosis and/or management of intracranial hypertension.</li><li class="elsevierStyleListItem" id="lsti0010">-Surgery for chronic subdural haematoma(s), including burr holes or mini-craniotomies.</li><li class="elsevierStyleListItem" id="lsti0015">-Elective (planned admission) or semi-elective procedures.</li><li class="elsevierStyleListItem" id="lsti0020">-Patients who have previously had emergency surgery for TBI and were eligible for inclusion in this study (regardless of whether they were eventually included or not).</li></ul>Data setThe data set is divided into three sections:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0025">-Injury and initial admission data.</li><li class="elsevierStyleListItem" id="lsti0030">-Operative data.</li><li class="elsevierStyleListItem" id="lsti0035">-Outcome data.</li></ul>Data will be collected via a secure online platform in anonymised form (Outcome Registry Intervention and Operation Network [ORION]; <a id="intr0025" class="elsevierStyleInterRef" href="https://orioncloud.org/">https://orioncloud.org/</a>).ResultsData related to initial presentation, operative intervention and short-term outcomes (14-day follow-up) will be collected, including patient demographics, details of injury mechanism, timing and nature of surgery, post-operative care and immediate post-operative complications. The primary outcome measure will be 14-day mortality.ApprovalThis study will assess current practice and no changes to standard patient management will be introduced. In accordance with the United Kingdom National Health Service (NHS) Health Research Authority, this study is considered a clinical audit rather than research and, as such, does not require approval by a Research Ethics Committee. Local teams are asked to gain approval from either their clinical audit or the research department of their institution prior to commencing the study, depending on which is the most appropriate at each site.LimitationsThe GNOS study may not provide global epidemiological data on the hospital treatment of all patients with TBI, due to the fact it focuses on patients treated through surgical intervention. However, it is hoped that the GNOS will constitute a strong foundation on which a global TBI registry can be implemented, supported by the WFNS (GEO-TBI registry).ConclusionThe objective of the GNOS study is to provide a global picture of the management and outcomes of patients treated with emergency surgery for TBI. In addition, it will establish a platform and clinical network that will facilitate future research in the neurotrauma field and on the role of neurosurgery.The full protocol and further relevant information can be found at: <a id="intr0030" class="elsevierStyleInterRef" href="https://globalneurotrauma.com/protocol/">https://globalneurotrauma.com/protocol/</a>.You can contact us at the following email address: <a id="intr0035" class="elsevierStyleInterRef" href="mailto:gnos@globalneurotrauma.com">gnos@globalneurotrauma.com</a>.The more units participate, the more meaningful the results will be.You can sign up at: <a id="intr0040" class="elsevierStyleInterRef" href="https://globalneurotrauma.com/sign-up/">https://globalneurotrauma.com/sign-up/</a>.Support and fundingThe study has the support of the World Federation of Neurological Surgeons (WFNS). Funding for the administrative costs of this study is provided by the NIHR Global Health Research Group on Neurotrauma.Conflicts of interestThe authors declare that they have no conflicts of interest." 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The GNOS is a multi-centre international, prospective cohort study. This study is the first global neurosurgical study that aims to provide a comprehensive picture of the management and outcomes of patients undergoing emergency surgery for TBI worldwide." ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "El traumatismo craneoencefálico (TCE) representa una cantidad significativa de muertes y discapacidad a nivel mundial, afectando la mayor parte de esta carga a los países con ingresos medios y bajos. El estudio GNOS es un estudio internacional multicéntrico de cohorte prospectiva. Es el primer estudio neuroquirúrgico global que tiene como objetivo proporcionar una imagen completa del manejo y los resultados de los pacientes que han sido tratados mediante cirugía urgente por TCE a nivel mundial." ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Panero Pérez I, Castaño León A-M, Gandía González ML, Kolias A. 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More effort is thus required in order to record reliable epidemiological data on the incidence&#44; management and prognosis of patients with TBIs in these types of environment with scant resources&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">In accordance with the United States&#8217; National Trauma Data Bank&#44; 3&#46;6&#37; of all patients with a head injury require surgical intervention&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a> but this value is significantly higher in patients with a severe TBI&#44; with worse outcomes in this particular patient group&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> It is widely recognised that the early evacuation of an intracranial haematoma dramatically improves outcomes&#46; However&#44; the Lancet Commission on Global Surgery estimates that 5 billion people worldwide lack access to surgical care&#44; including neurosurgical interventions&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Objective</span><p id="par0015" class="elsevierStylePara elsevierViewall">In this context&#44; the Global Neurotrauma Outcomes Study &#40;GNOS&#41; is the first global neurosurgical study which aims to provide a full and global picture of the management and outcomes of patients who have undergone emergency surgery due to TBI&#44; comparing outcomes between countries with a high and low Human Development Index &#40;HDI&#41;&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Study design</span><p id="par0020" class="elsevierStylePara elsevierViewall">The GNOS is a multicentre&#44; international&#44; prospective cohort study&#44; which will be carried out by a team of principal investigators from the National Institute for Health Research &#40;NIHR&#41; Global Health Research Group from the United Kingdom&#44; Africa&#44; Asia and South America&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The study has the support of the World Federation of Neurological Surgeons &#40;WFNS&#41;&#46; Funding for the administrative costs of this study is provided by the NIHR Global Health Research Group on Neurotrauma&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The study involves a working methodology that combines surgeons from different hospitals &#40;multicentre study&#41; working together to compile data in a prospective manner&#46; This type of methodology has been used successfully in the past&#46; Resident surgeons have accordingly played a key role in previous studies &#40;<a id="intr0010" class="elsevierStyleInterRef" href="https://www.ncbi.nlm.nih.gov/pubmed/25584384">https&#58;&#47;&#47;www&#46;ncbi&#46;nlm&#46;nih&#46;gov&#47;pubmed&#47;25584384</a>&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> In the neurosurgery setting&#44; the British Neurosurgical Trainee Research Collaborative has brought together neurosurgery residents from all over the United Kingdom and successfully completed various observational studies &#40;<a id="intr0015" class="elsevierStyleInterRef" href="https://www.ncbi.nlm.nih.gov/pubmed/29101466">https&#58;&#47;&#47;www&#46;ncbi&#46;nlm&#46;nih&#46;gov&#47;pubmed&#47;29101466</a>&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> In general surgery&#44; the international working group GlobalSurg has gathered every continent&#44; successfully enrolling 23&#44;000 patients in its first two studies &#40;<a id="intr0020" class="elsevierStyleInterRef" href="http://globalsurg.org/">http&#58;&#47;&#47;globalsurg&#46;org</a>&#41;&#46; The methodology adopted in the GNOS is similar to the one used in these studies&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Methods</span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Inclusion period and study duration</span><p id="par0035" class="elsevierStylePara elsevierViewall">Between 1 October 2018 and 1 April 2019&#44; all patients undergoing emergency surgery for a TBI in the first 30 days after the accident will be included&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">A 30-day period will be chosen in between these dates for data collection&#46; As of the surgery date&#44; the teams must monitor patients for 14 days or until they are discharged or die&#44; whichever occurs first&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Site inclusion criteria</span><p id="par0045" class="elsevierStylePara elsevierViewall">Any hospital or clinic where emergency surgery is performed on patients who have presented with a TBI may take part&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Development of a local team</span><p id="par0050" class="elsevierStylePara elsevierViewall">The neurosurgeons at each participating unit will form a study team&#44; which will be responsible for gaining the local approval of the research committee at the study team&#39;s institution&#44; as well as for identifying patients and conducting data collection&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The local study team will comprise a principal investigator and up to two additional members who will help him&#47;her to collect all the data&#44; as well as an independent reviewer who ensures that the data collected are correct&#46; These will be cited on PubMed as collaborator status authors on all publications resulting from the study&#46; Similarly&#44; once the study is complete&#44; they may request access to the entire data set or a subset thereof in order to perform post hoc analysis which enables them to answer any study-specific questions&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Patient inclusion criteria</span><p id="par0060" class="elsevierStylePara elsevierViewall">Adult and paediatric patients admitted to the site following a TBI who require emergency surgery for intracranial lesions in the first 30 days after admission&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Exclusion criteria</span><p id="par0065" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0070" class="elsevierStylePara elsevierViewall">Patients who only have a device inserted for the diagnosis and&#47;or management of intracranial hypertension&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0075" class="elsevierStylePara elsevierViewall">Surgery for chronic subdural haematoma&#40;s&#41;&#44; including burr holes or mini-craniotomies&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0080" class="elsevierStylePara elsevierViewall">Elective &#40;planned admission&#41; or semi-elective procedures&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">-</span><p id="par0085" class="elsevierStylePara elsevierViewall">Patients who have previously had emergency surgery for TBI and were eligible for inclusion in this study &#40;regardless of whether they were eventually included or not&#41;&#46;</p></li></ul></p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Data set</span><p id="par0090" class="elsevierStylePara elsevierViewall">The data set is divided into three sections&#58;<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">-</span><p id="par0095" class="elsevierStylePara elsevierViewall">Injury and initial admission data&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">-</span><p id="par0100" class="elsevierStylePara elsevierViewall">Operative data&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">-</span><p id="par0105" class="elsevierStylePara elsevierViewall">Outcome data&#46;</p></li></ul></p><p id="par0110" class="elsevierStylePara elsevierViewall">Data will be collected via a secure online platform in anonymised form &#40;Outcome Registry Intervention and Operation Network &#91;ORION&#93;&#59; <a id="intr0025" class="elsevierStyleInterRef" href="https://orioncloud.org/">https&#58;&#47;&#47;orioncloud&#46;org&#47;</a>&#41;&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0115" class="elsevierStylePara elsevierViewall">Data related to initial presentation&#44; operative intervention and short-term outcomes &#40;14-day follow-up&#41; will be collected&#44; including patient demographics&#44; details of injury mechanism&#44; timing and nature of surgery&#44; post-operative care and immediate post-operative complications&#46; The primary outcome measure will be 14-day mortality&#46;</p><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Approval</span><p id="par0120" class="elsevierStylePara elsevierViewall">This study will assess current practice and no changes to standard patient management will be introduced&#46; In accordance with the United Kingdom National Health Service &#40;NHS&#41; Health Research Authority&#44; this study is considered a clinical audit rather than research and&#44; as such&#44; does not require approval by a Research Ethics Committee&#46; Local teams are asked to gain approval from either their clinical audit or the research department of their institution prior to commencing the study&#44; depending on which is the most appropriate at each site&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Limitations</span><p id="par0125" class="elsevierStylePara elsevierViewall">The GNOS study may not provide global epidemiological data on the hospital treatment of all patients with TBI&#44; due to the fact it focuses on patients treated through surgical intervention&#46; However&#44; it is hoped that the GNOS will constitute a strong foundation on which a global TBI registry can be implemented&#44; supported by the WFNS &#40;GEO-TBI registry&#41;&#46;</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Conclusion</span><p id="par0130" class="elsevierStylePara elsevierViewall">The objective of the GNOS study is to provide a global picture of the management and outcomes of patients treated with emergency surgery for TBI&#46; In addition&#44; it will establish a platform and clinical network that will facilitate future research in the neurotrauma field and on the role of neurosurgery&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">The full protocol and further relevant information can be found at&#58; <a id="intr0030" class="elsevierStyleInterRef" href="https://globalneurotrauma.com/protocol/">https&#58;&#47;&#47;globalneurotrauma&#46;com&#47;protocol&#47;</a>&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">You can contact us at the following email address&#58; <a id="intr0035" class="elsevierStyleInterRef" href="mailto:gnos@globalneurotrauma.com">gnos&#64;globalneurotrauma&#46;com</a>&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">The more units participate&#44; the more meaningful the results will be&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">You can sign up at&#58; <a id="intr0040" class="elsevierStyleInterRef" href="https://globalneurotrauma.com/sign-up/">https&#58;&#47;&#47;globalneurotrauma&#46;com&#47;sign-up&#47;</a>&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Support and funding</span><p id="par0155" class="elsevierStylePara elsevierViewall">The study has the support of the World Federation of Neurological Surgeons &#40;WFNS&#41;&#46; Funding for the administrative costs of this study is provided by the NIHR Global Health Research Group on Neurotrauma&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Conflicts of interest</span><p id="par0160" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest&#46;</p></span></span>"
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                      "titulo" => "The British Neurosurgical Trainee Research Collaborative&#58; five years on"
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                          "autores" => array:6 [
                            0 => "A&#46; Chari"
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                            4 => "I&#46;C&#46; Coulter"
                            5 => "R&#46; Ma"
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                        "tituloSerie" => "Acta Neurochir &#40;Wien&#41; Austria"
                        "fecha" => "2018"
                        "volumen" => "160"
                        "paginaInicial" => "23"
                        "paginaFinal" => "28"
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        "identificador" => "xack394465"
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        "texto" => "<p id="par0165" class="elsevierStylePara elsevierViewall">The NIHR Global Health Research Group on Neurotrauma was commissioned by the NIHR using funds from the Official Development Assistance &#40;ODA&#41; &#40;project 16&#47;137&#47;105&#41;&#46; The opinions expressed herein are those of the author&#40;s&#41; and do not necessarily reflect those of the NHS&#44; the National Institute for Health Research or the Department of Health&#46;</p>"
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