Your browser doesn't support javascript.
loading
: 20 | 50 | 100
1 - 20 de 109
1.
Neurocrit Care ; 2024 May 29.
Article En | MEDLINE | ID: mdl-38811514

BACKGROUND: Numerous trials have addressed intracranial pressure (ICP) management in neurocritical care. However, identifying its harmful thresholds and controlling ICP remain challenging in terms of improving outcomes. Evidence suggests that an individualized approach is necessary for establishing tolerance limits for ICP, incorporating factors such as ICP waveform (ICPW) or pulse morphology along with additional data provided by other invasive (e.g., brain oximetry) and noninvasive monitoring (NIM) methods (e.g., transcranial Doppler, optic nerve sheath diameter ultrasound, and pupillometry). This study aims to assess current ICP monitoring practices among experienced clinicians and explore whether guidelines should incorporate ancillary parameters from NIM and ICPW in future updates. METHODS: We conducted a survey among experienced professionals involved in researching and managing patients with severe injury across low-middle-income countries (LMICs) and high-income countries (HICs). We sought their insights on ICP monitoring, particularly focusing on the impact of NIM and ICPW in various clinical scenarios. RESULTS: From October to December 2023, 109 professionals from the Americas and Europe participated in the survey, evenly distributed between LMIC and HIC. When ICP ranged from 22 to 25 mm Hg, 62.3% of respondents were open to considering additional information, such as ICPW and other monitoring techniques, before adjusting therapy intensity levels. Moreover, 77% of respondents were inclined to reassess patients with ICP in the 18-22 mm Hg range, potentially escalating therapy intensity levels with the support of ICPW and NIM. Differences emerged between LMIC and HIC participants, with more LMIC respondents preferring arterial blood pressure transducer leveling at the heart and endorsing the use of NIM techniques and ICPW as ancillary information. CONCLUSIONS: Experienced clinicians tend to personalize ICP management, emphasizing the importance of considering various monitoring techniques. ICPW and noninvasive techniques, particularly in LMIC settings, warrant further exploration and could potentially enhance individualized patient care. The study suggests updating guidelines to include these additional components for a more personalized approach to ICP management.

2.
3.
Neurosurgery ; 2024 Mar 26.
Article En | MEDLINE | ID: mdl-38529956

Moderate traumatic brain injury (TBI) is a diagnosis that describes diverse patients with heterogeneity of primary injuries. Defined by a Glasgow Coma Scale between 9 and 12, this category includes patients who may neurologically worsen and require increasing intensive care resources and/or emergency neurosurgery. Despite the unique characteristics of these patients, there have not been specific guidelines published before this effort to support decision-making in these patients. A Delphi consensus group from the Latin American Brain Injury Consortium was established to generate recommendations related to the definition and categorization of moderate TBI. Before an in-person meeting, a systematic review of the literature was performed identifying evidence relevant to planned topics. Blinded voting assessed support for each recommendation. A priori the threshold for consensus was set at 80% agreement. Nine PICOT questions were generated by the panel, including definition, categorization, grouping, and diagnosis of moderate TBI. Here, we report the results of our work including relevant consensus statements and discussion for each question. Moderate TBI is an entity for which there is little published evidence available supporting definition, diagnosis, and management. Recommendations based on experts' opinion were informed by available evidence and aim to refine the definition and categorization of moderate TBI. Further studies evaluating the impact of these recommendations will be required.

4.
Biomedicines ; 12(3)2024 Feb 26.
Article En | MEDLINE | ID: mdl-38540133

Traumatic Brain Injury (TBI) remains a leading cause of morbidity and mortality among all ages; despite the advances, understanding pathophysiological responses after TBI is still complex, involving multiple mechanisms. Previous reviews have focused on potential targets; however, the research on potential targets has continuously grown in the last five years, bringing even more alternatives and elucidating previous mechanisms. Knowing the key and updated pathophysiology concepts is vital for adequate management and better outcomes. This article reviews the underlying molecular mechanisms, the latest updates, and future directions for pathophysiology-based TBI management.

5.
Global Spine J ; 14(3_suppl): 174S-186S, 2024 Mar.
Article En | MEDLINE | ID: mdl-38526922

STUDY DESIGN: Clinical practice guideline development. OBJECTIVES: Acute spinal cord injury (SCI) can result in devastating motor, sensory, and autonomic impairment; loss of independence; and reduced quality of life. Preclinical evidence suggests that early decompression of the spinal cord may help to limit secondary injury, reduce damage to the neural tissue, and improve functional outcomes. Emerging evidence indicates that "early" surgical decompression completed within 24 hours of injury also improves neurological recovery in patients with acute SCI. The objective of this clinical practice guideline (CPG) is to update the 2017 recommendations on the timing of surgical decompression and to evaluate the evidence with respect to ultra-early surgery (in particular, but not limited to, <12 hours after acute SCI). METHODS: A multidisciplinary, international, guideline development group (GDG) was formed that consisted of spine surgeons, neurologists, critical care specialists, emergency medicine doctors, physical medicine and rehabilitation professionals, as well as individuals living with SCI. A systematic review was conducted based on accepted methodological standards to evaluate the impact of early (within 24 hours of acute SCI) or ultra-early (in particular, but not limited to, within 12 hours of acute SCI) surgery on neurological recovery, functional outcomes, administrative outcomes, safety, and cost-effectiveness. The GRADE approach was used to rate the overall strength of evidence across studies for each primary outcome. Using the "evidence-to-recommendation" framework, recommendations were then developed that considered the balance of benefits and harms, financial impact, patient values, acceptability, and feasibility. The guideline was internally appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. RESULTS: The GDG recommended that early surgery (≤24 hours after injury) be offered as the preferred option for adult patients with acute SCI regardless of level. This recommendation was based on moderate evidence suggesting that patients were 2 times more likely to recover by ≥ 2 ASIA Impairment Score (AIS) grades at 6 months (RR: 2.76, 95% CI 1.60 to 4.98) and 12 months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24 hours compared to after 24 hours. Furthermore, patients undergoing early surgery improved by an additional 4.50 (95% 1.70 to 7.29) points on the ASIA Motor Score compared to patients undergoing surgery after 24 hours post-injury. The GDG also agreed that a recommendation for ultra-early surgery could not be made on the basis of the current evidence because of the small sample sizes, variable definitions of what constituted ultra-early in the literature, and the inconsistency of the evidence. CONCLUSIONS: It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24 hours after injury when medically feasible. Future research is required to determine the differential effectiveness of early surgery in different subpopulations and the impact of ultra-early surgery on neurological recovery. Moreover, further work is required to define what constitutes effective spinal cord decompression and to individualize care. It is also recognized that a concerted international effort will be required to translate these recommendations into policy.

6.
Global Spine J ; 14(3_suppl): 212S-222S, 2024 Mar.
Article En | MEDLINE | ID: mdl-38526921

STUDY DESIGN: Development of a clinical practice guideline following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process. OBJECTIVE: The objectives of this study were to develop guidelines that outline the utility of intraoperative neuromonitoring (IONM) to detect intraoperative spinal cord injury (ISCI) among patients undergoing spine surgery, to define a subset of patients undergoing spine surgery at higher risk for ISCI and to develop protocols to prevent, diagnose, and manage ISCI. METHODS: All systematic reviews were performed according to PRISMA standards and registered on PROSPERO. A multidisciplinary, international Guidelines Development Group (GDG) reviewed and discussed the evidence using GRADE protocols. Consensus was defined by 80% agreement among GDG members. A systematic review and diagnostic test accuracy (DTA) meta-analysis was performed to synthesize pooled evidence on the diagnostic accuracy of IONM to detect ISCI among patients undergoing spinal surgery. The IONM modalities evaluated included somatosensory evoked potentials (SSEPs), motor evoked potentials (MEPs), electromyography (EMG), and multimodal neuromonitoring. Utilizing this knowledge and their clinical experience, the multidisciplinary GDG created recommendations for the use of IONM to identify ISCI in patients undergoing spine surgery. The evidence related to existing care pathways to manage ISCI was summarized and based on this a novel AO Spine-PRAXIS care pathway was created. RESULTS: Our recommendations are as follows: (1) We recommend that intraoperative neurophysiological monitoring be employed for high risk patients undergoing spine surgery, and (2) We suggest that patients at "high risk" for ISCI during spine surgery be proactively identified, that after identification of such patients, multi-disciplinary team discussions be undertaken to manage patients, and that an intraoperative protocol including the use of IONM be implemented. A care pathway for the prevention, diagnosis, and management of ISCI has been developed by the GDG. CONCLUSION: We anticipate that these guidelines will promote the use of IONM to detect and manage ISCI, and promote the use of preoperative and intraoperative checklists by surgeons and other team members for high risk patients undergoing spine surgery. We welcome teams to implement and evaluate the care pathway created by our GDG.

7.
Turk Neurosurg ; 34(1): 135-141, 2024.
Article En | MEDLINE | ID: mdl-38282592

AIM: To discuss adherence to guidelines for the management of traumatic brain injury (TBI) in Türkiye and physicians' attitudes toward standardized, evidence-based medical practice. MATERIAL AND METHODS: Survey questions were uploaded on the website www.surveymonkey.com and sent to the participants via e-mail or social media applications. The first 10 questions were about the participants' profiles, and the rest were purposed on presenting the physicians' viewpoint on and barriers against CPG adherence. SPSS version 17.0 for Windows was used for statistical analysis. RESULTS: A total of 404 physicians (neurosurgeons, 59.5%; anesthesiologists, 16.7%; and emergency medicine practitioners, 23.9%) who were involved in TBI management were included in this study. Of them, 61.7% stated that they frequently adhere to the CPG recommendations for TBI. In their own experience, most of the respondents agreed that CPGs frequently improve outcomes. They stated that they would occasionally or never adopt recommendations with weak evidence. Physicians reached a consensus on individualizing the decision-making along with the CPG recommendations. CONCLUSION: Of the participants, 61% adopted the CPG recommendations. The main barriers to the implementation of the CPGs are the strength of evidence levels and the affordability of the recommendations.


Brain Injuries, Traumatic , Humans , Turkey , Surveys and Questionnaires , Brain Injuries, Traumatic/therapy
8.
World J Emerg Surg ; 19(1): 4, 2024 01 18.
Article En | MEDLINE | ID: mdl-38238783

BACKGROUND: The early management of polytrauma patients with traumatic spinal cord injury (tSCI) is a major challenge. Sparse data is available to provide optimal care in this scenario and worldwide variability in clinical practice has been documented in recent studies. METHODS: A multidisciplinary consensus panel of physicians selected for their established clinical and scientific expertise in the acute management of tSCI polytrauma patients with different specializations was established. The World Society of Emergency Surgery (WSES) and the European Association of Neurosurgical Societies (EANS) endorsed the consensus, and a modified Delphi approach was adopted. RESULTS: A total of 17 statements were proposed and discussed. A consensus was reached generating 17 recommendations (16 strong and 1 weak). CONCLUSIONS: This consensus provides practical recommendations to support a clinician's decision making in the management of tSCI polytrauma patients.


Multiple Trauma , Spinal Cord Injuries , Adult , Humans , Consensus , Spinal Cord Injuries/complications , Spinal Cord Injuries/surgery , Multiple Trauma/surgery
10.
Oper Neurosurg (Hagerstown) ; 26(3): 247-255, 2024 Mar 01.
Article En | MEDLINE | ID: mdl-37976141

Traumatic brain injury is often associated with a direct or secondary neurovascular pathology. In this review, we present recent advancements in endovascular neurosurgery that enable accurate and effective vessel reconstruction with emphasis on its role in early diagnosis, the expanding use of flow diversion in pseudoaneurysms, and traumatic arteriovenous fistulas. In addition, future directions in which catheter-based interventions could potentially affect traumatic brain injury are described: targeting blood brain barrier integrity using the advantages of intra-arterial drug delivery of blood brain barrier stabilizers to prevent secondary brain edema, exploring the impact of endovascular venous access as a means to modulate venous outflow in an attempt to reduce intracranial pressure and augment brain perfusion, applying selective intra-arterial hypothermia as a neuroprotection method mitigating some of the risks conferred by systemic cooling, trans-vessel wall delivery of regenerative therapy agents, and shifting attention using multimodal neuromonitoring to post-traumatic vasospasm to further characterize the role it plays in secondary brain injury. Thus, we believe that the potential of endovascular tools can be expanded because they enable access to the "highways" governing perfusion and flow and call for further research focused on exploring these routes because it may contribute to novel endovascular approaches currently used for treating injured vessels, harnessing them for treatment of the injured brain.


Brain Edema , Brain Injuries, Traumatic , Brain Neoplasms , Humans , Brain/pathology , Brain Edema/pathology , Brain Neoplasms/pathology
11.
J Neurosurg ; : 1-11, 2023 Nov 17.
Article En | MEDLINE | ID: mdl-37976508

OBJECTIVE: Different paradigms for neurocritical care of traumatic brain injury (TBI) have emerged in conjunction with advanced neuromonitoring technologies and derived metrics. The priority for optimizing these metrics is not currently clear. The goal of this study was to determine whether achieving cerebral perfusion pressure (CPPopt) also improves other metrics like brain oxygenation and brain blood flow. METHODS: The authors performed a retrospective analysis of high-frequency data from patients with TBI who were treated at a single center and who had partial pressure of brain oxygen (PbtO2) measurements and/or brain blood flow measurements, while also undergoing intracranial pressure (ICP) monitoring. CPPopt was not calculated or targeted during patient care, but was retrospectively computed, as was the difference between the observed CPP and CPPopt. RESULTS: A total of 22 patients with ICP, PbtO2, and/or brain blood flow monitoring were included in the analysis, and 245.7 days of measurements obtained every second were analyzed including 6,748,866 PbtO2 measurements, 3,296,405 blood flow measurements, and 10,264,770 ICP measurements. The data obtained every second were averaged by minute for analysis. In summative data, PbtO2 measurements peaked near CPPopt and were not improved above CPPopt. Blood flow measurements remained stable near CPPopt, decreased below it, and increased when CPP exceeded CPPopt. ICP decreased linearly with CPP without a specific relationship with CPPopt. In an inverse analysis, the percentage of CPP values at CPPopt, although significantly higher on the favorable side of contemporary treatment thresholds of PbtO2, ICP, and blood flow, was not found to be strongly correlated with the mean values of the physiological measurements obtained every minute (r = 0.27, r = 0.11, and r = 0.47 for ICP, PbtO2, and blood flow, respectively; p < 0.0001). CONCLUSIONS: Although CPPopt was not targeted in the patients in this study, CPPopt was a physiologically significant value based on concurrent measurements of PbtO2 and blood flow. In summative data, achievement of CPPopt was associated with optimized PbtO2 and blood flow. Conversely, the correlation between achievement of CPPopt and the mean measurement value was not strong, strengthening the significance of CPPopt. In individual patients, achieving CPPopt is not always associated with optimal PbtO2 or blood flow. Further research should explore these relationships in treatment paradigms that specifically target CPPopt. These data do not support the premise that targeting and achieving CPPopt obviates the need for concurrent PbtO2 and blood flow monitoring. Although these data suggest that targeting CPPopt may be an appropriate initial treatment strategy, they do not provide evidence that CPPopt should be targeted with highest priority.

12.
Neurosurgery ; 93(6): e159-e169, 2023 12 01.
Article En | MEDLINE | ID: mdl-37750693

Prehospital care markedly influences outcome from traumatic brain injury, yet it remains highly variable. The Brain Trauma Foundation's guidelines informing prehospital care, first published in 2002, have sought to identify and disseminate best practices. Many of its recommendations relate to the management of airway, breathing and circulation, and infrastructure for this care. Compliance with the second edition of these guidelines has been associated with significantly improved survival. A working group developed evidence-based recommendations informing assessment, treatment, and transport decision-making relevant to the prehospital care of brain injured patients. A literature search spanning May 2005 to January 2022 supplemented data contained in the 2nd edition. Identified studies were assessed for quality and used to inform evidence-based recommendations. A total of 122 published articles formed the evidentiary base for this guideline update including 5 providing Class I evidence, 35 providing Class II evidence, and 98 providing Class III evidence for the various topics. Forty evidence-based recommendations were generated, 30 of which were strong and 10 of which were weak. In many cases, new evidence allowed guidelines from the 2nd edition to be strengthened. Development of guidelines on some new topics was possible including the prehospital administration of tranexamic acid. A management algorithm is also presented. These guidelines help to identify best practices for prehospital traumatic brain injury care, and they also identify gaps in knowledge which we hope will be addressed before the next edition.


Brain Injuries, Traumatic , Emergency Medical Services , Humans , Brain Injuries, Traumatic/diagnosis , Brain Injuries, Traumatic/therapy , Brain , Algorithms
13.
Neurosurgery ; 93(2): 399-408, 2023 08 01.
Article En | MEDLINE | ID: mdl-37171175

BACKGROUND: Intracranial pressure (ICP) monitoring is widely practiced, but the indications are incompletely developed, and guidelines are poorly followed. OBJECTIVE: To study the monitoring practices of an established expert panel (the clinical working group from the Seattle International Brain Injury Consensus Conference effort) to examine the match between monitoring guidelines and their clinical decision-making and offer guidance for clinicians considering monitor insertion. METHODS: We polled the 42 Seattle International Brain Injury Consensus Conference panel members' ICP monitoring decisions for virtual patients, using matrices of presenting signs (Glasgow Coma Scale [GCS] total or GCS motor, pupillary examination, and computed tomography diagnosis). Monitor insertion decisions were yes, no, or unsure (traffic light approach). We analyzed their responses for weighting of the presenting signs in decision-making using univariate regression. RESULTS: Heatmaps constructed from the choices of 41 panel members revealed wider ICP monitor use than predicted by guidelines. Clinical examination (GCS) was by far the most important characteristic and differed from guidelines in being nonlinear. The modified Marshall computed tomography classification was second and pupils third. We constructed a heatmap and listed the main clinical determinants representing 80% ICP monitor insertion consensus for our recommendations. CONCLUSION: Candidacy for ICP monitoring exceeds published indicators for monitor insertion, suggesting the clinical perception that the value of ICP data is greater than simply detecting and monitoring severe intracranial hypertension. Monitor insertion heatmaps are offered as potential guidance for ICP monitor insertion and to stimulate research into what actually drives monitor insertion in unconstrained, real-world conditions.


Brain Injuries, Traumatic , Brain Injuries , Intracranial Hypertension , Humans , Intracranial Pressure/physiology , Brain Injuries, Traumatic/diagnosis , Intracranial Hypertension/diagnosis , Glasgow Coma Scale , Monitoring, Physiologic/methods
16.
Brain Inj ; 37(10): 1167-1172, 2023 08 24.
Article En | MEDLINE | ID: mdl-36856437

BACKGROUND/OBJECTIVE: Levetiracetam is used for seizure prophylaxis in patients presenting with subarachnoid hemorrhage (SAH) or traumatic brain injury (TBI). We aim to characterize the optimal levetiracetam dosage for seizure prophylaxis. METHODS: This retrospective cohort study included adult patients at an academic tertiary hospital presenting with SAH or TBI who received levetiracetam at a total daily dose (TDD) equivalent to or greater than 1000 mg. The primary outcome was combined seizure incidence, including clinical and subclinical seizures. RESULTS: We identified 139 patients (49.6% male, mean age 53 years) for inclusion. For patients receiving a 1000-mg TDD, the administration was 500 mg twice daily. For patients receiving >1000-mg TDD, 77/78 patients received 1000 mg twice daily and one patient received 750 mg twice daily. Patients receiving 1000-mg TDD had a higher seizure incidence than those receiving >1000-mg TDD (p = 0.01), despite no difference in examined confounders, including history of alcoholism (p = 0.49), benzodiazepine use (p = 0.28), or propofol use (p = 0.17). No difference in adverse effects was observed (anemia, p = 0.44; leukopenia, p = 0.60; thrombocytopenia, p = 0.86). CONCLUSIONS: Patients may experience a reduced incidence of clinical and electroencephalographic seizures with levetiracetam dosing >1000-mg TDD.


Brain Injuries, Traumatic , Piracetam , Subarachnoid Hemorrhage , Adult , Humans , Male , Middle Aged , Female , Levetiracetam/therapeutic use , Anticonvulsants/therapeutic use , Piracetam/therapeutic use , Phenytoin/therapeutic use , Retrospective Studies , Seizures/drug therapy , Seizures/prevention & control , Seizures/etiology , Brain Injuries, Traumatic/complications , Brain Injuries, Traumatic/drug therapy , Subarachnoid Hemorrhage/complications , Subarachnoid Hemorrhage/drug therapy
17.
J Neurotrauma ; 40(15-16): 1707-1717, 2023 08.
Article En | MEDLINE | ID: mdl-36932737

Abstract Best practice guidelines have advanced severe traumatic brain injury (TBI) care; however, there is little that currently informs goals of care decisions and processes despite their importance and frequency. Panelists from the Seattle International severe traumatic Brain Injury Consensus Conference (SIBICC) participated in a survey consisting of 24 questions. Questions queried use of prognostic calculators, variability in and responsibility for goals of care decisions, and acceptability of neurological outcomes, as well as putative means of improving decisions that might limit care. A total of 97.6% of the 42 SIBICC panelists completed the survey. Responses to most questions were highly variable. Overall, panelists reported infrequent use of prognostic calculators, and observed variability in patient prognostication and goals of care decisions. They felt that it would be beneficial for physicians to improve consensus on what constitutes an acceptable neurological outcome as well as what chance of achieving that outcome is acceptable. Panelists felt that the public should help to define what constitutes a good outcome and expressed some support for a "nihilism guard." More than 50% of panelists felt that if it was certain to be permanent, a vegetative state or lower severe disability would justify a withdrawal of care decision, whereas 15% felt that upper severe disability justified such a decision. Whether conceptualizing an ideal or existing prognostic calculator to predict death or an unacceptable outcome, on average a 64-69% chance of a poor outcome was felt to justify treatment withdrawal. These results demonstrate important variability in goals of care decision making and a desire to reduce this variability. Our panel of recognized TBI experts opined on the neurological outcomes and chances of those outcomes that might prompt consideration of care withdrawal; however, imprecision of prognostication and existing prognostication tools is a significant impediment to standardizing the approach to care-limiting decisions.


Brain Injuries, Traumatic , Disabled Persons , Humans , Brain Injuries, Traumatic/diagnosis , Brain Injuries, Traumatic/therapy , Prognosis , Consensus , Patient Care Planning
19.
World J Emerg Surg ; 18(1): 5, 2023 01 09.
Article En | MEDLINE | ID: mdl-36624517

BACKGROUND: Severe traumatic brain-injured (TBI) patients should be primarily admitted to a hub trauma center (hospital with neurosurgical capabilities) to allow immediate delivery of appropriate care in a specialized environment. Sometimes, severe TBI patients are admitted to a spoke hospital (hospital without neurosurgical capabilities), and scarce data are available regarding the optimal management of severe isolated TBI patients who do not have immediate access to neurosurgical care. METHODS: A multidisciplinary consensus panel composed of 41 physicians selected for their established clinical and scientific expertise in the acute management of TBI patients with different specializations (anesthesia/intensive care, neurocritical care, acute care surgery, neurosurgery and neuroradiology) was established. The consensus was endorsed by the World Society of Emergency Surgery, and a modified Delphi approach was adopted. RESULTS: A total of 28 statements were proposed and discussed. Consensus was reached on 22 strong recommendations and 3 weak recommendations. In three cases, where consensus was not reached, no recommendation was provided. CONCLUSIONS: This consensus provides practical recommendations to support clinician's decision making in the management of isolated severe TBI patients in centers without neurosurgical capabilities and during transfer to a hub center.


Brain Injuries, Traumatic , Humans , Brain Injuries, Traumatic/surgery , Hospitals , Brain , Neurosurgical Procedures , Hospitalization
20.
JMIR Res Protoc ; 12: e37442, 2023 Apr 17.
Article En | MEDLINE | ID: mdl-35759752

BACKGROUND: Core outcome sets (COSs) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury (TBI) or stroke is becoming increasingly common, leading to an ever-growing clinical and research interest, especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardized COS for reporting in all future TBI and stroke cranioplasty studies. OBJECTIVE: This study has four aims: (1) undertake a systematic review to collate the most current outcome measures used within the cranioplasty literature; (2) undertake a qualitative study to understand better the views of clinicians, patients' relatives, and allied health professionals regarding clinical outcomes following cranioplasty; (3) undertake a Delphi survey as part of the process of gaining consensus for the COS; and (4) finalize consensus through a consensus meeting resulting in the COS. METHODS: An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. Phase 1 is data collection through a systematic review and qualitative study. Phase 2 is the COS development through a Delphi survey and consensus meetings with consensus definitions decided and agreed upon before the Delphi survey begins to avoid bias. RESULTS: Phase 1 started at the end of 2019, following ethical approval in December 2019, and the project completion date is planned for the end of 2022 or beginning of 2023. CONCLUSIONS: This study should result in a consensus on a COS for cranioplasty, following TBI or stroke, to help standardize outcome reporting for future studies, which can be applied to future research and clinical services, help align future studies, build an increased understanding of cranioplasty and its impact on a patient's function and recovery, and help standardize the evidence base. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37442.

...