Symptoms Associated With Exercise Intolerance and Resting Heart Rate Following Mild Traumatic Brain Injury.

OBJECTIVES: People may experience a myriad of symptoms after mild traumatic brain injury (mTBI), but the relationship between symptoms and objective assessments is poorly characterized. This study sought to investigate the association between symptoms, resting heart rate (HR), and exercise tolerance in individuals following mTBI, with a secondary aim to examine the relationship between symptom-based clinical profiles and recovery. METHODS: Prospective observational study of adults aged 18 to 65 years who had sustained mTBI within the previous 7 days. Symptoms were assessed using the Post-Concussion Symptom Scale, HR was measured at rest, and exercise tolerance was assessed using the Buffalo Concussion Bike Test. Symptom burden and symptom-based clinical profiles were examined with respect to exercise tolerance and resting HR. RESULTS: Data from 32 participants were assessed (mean age 36.5 ± 12.6 years, 41% female, 5.7 ± 1.1 days since injury). Symptom burden (number of symptoms and symptom severity) was significantly associated with exercise intolerance (P = .002 and P = .025, respectively). Physiological and vestibular-ocular clinical profile composite groups were associated with exercise tolerance (P = .001 and P = .014, respectively), with individuals who were exercise intolerant having a higher mean number of symptoms in each profile than those who were exercise tolerant. Mood-related and autonomic clinical profiles were associated with a higher resting HR (>80 bpm) (P = .048 and P = .028, respectively), suggesting altered autonomic response for participants with symptoms relating to this profile. After adjusting for age and mechanism of injury (sports- or non-sports-related), having a higher mood-related clinical profile was associated with persisting symptoms at 3 months postinjury (adjusted odds ratio = 2.08; 95% CI, 1.11-3.90; P = .013). CONCLUSION: Symptom-based clinical profiles, in conjunction with objective measures such as resting HR and exercise tolerance, are important components of clinical care for those having sustained mTBI. These results provide preliminary support for the concept that specific symptoms are indicative of autonomic dysfunction following mTBI.

A Multicenter Trial of Vena Cava Filters in Severely Injured Patients.

BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).

Neurotrauma, COVID and the rationing of intensive care: an ethical approach.

The advent of the COVID-19 pandemic with its extreme pressure on resources and intensive care beds has prompted many healthcare providers to consider more fully the potentially futile nature of some treatments and how resources might be better managed. This is especially relevant in the context of neurosurgery which is highly resource dependent in terms of technology, funding, and manpower and it may be difficult to balance fair, equitable and sustainable resource allocation, especially in circumstances where those healthcare resources become limited or completely exhausted. Indeed, it may be necessary to consider limiting the availability of certain neurosurgical services or perhaps reconsider the utility or otherwise of performing procedures that commit very restricted resources, such as intensive care beds, to patients who are arguably receiving limited long-term benefit. In these circumstances, the decision-making paradigm is challenging and there are several ethically disparate viewpoints that need to be reconciled. These include but are not limited to, Futility, Utilitarianism and the Rule of rescue.

Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project.

IMPORTANCE: There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries. OBJECTIVE: To formulate a consensus statement of recommendations on determination of BD/DNC based on review of the literature and expert opinion of a large multidisciplinary, international panel. PROCESS: Relevant international professional societies were recruited to develop recommendations regarding determination of BD/DNC. Literature searches of the Cochrane, Embase, and MEDLINE databases included January 1, 1992, through April 2020 identified pertinent articles for review. Because of the lack of high-quality data from randomized clinical trials or large observational studies, recommendations were formulated based on consensus of contributors and medical societies that represented relevant disciplines, including critical care, neurology, and neurosurgery. EVIDENCE SYNTHESIS: Based on review of the literature and consensus from a large multidisciplinary, international panel, minimum clinical criteria needed to determine BD/DNC in various circumstances were developed. RECOMMENDATIONS: Prior to evaluating a patient for BD/DNC, the patient should have an established neurologic diagnosis that can lead to the complete and irreversible loss of all brain function, and conditions that may confound the clinical examination and diseases that may mimic BD/DNC should be excluded. Determination of BD/DNC can be done with a clinical examination that demonstrates coma, brainstem areflexia, and apnea. This is seen when (1) there is no evidence of arousal or awareness to maximal external stimulation, including noxious visual, auditory, and tactile stimulation; (2) pupils are fixed in a midsize or dilated position and are nonreactive to light; (3) corneal, oculocephalic, and oculovestibular reflexes are absent; (4) there is no facial movement to noxious stimulation; (5) the gag reflex is absent to bilateral posterior pharyngeal stimulation; (6) the cough reflex is absent to deep tracheal suctioning; (7) there is no brain-mediated motor response to noxious stimulation of the limbs; and (8) spontaneous respirations are not observed when apnea test targets reach pH <7.30 and Paco2 ≥60 mm Hg. If the clinical examination cannot be completed, ancillary testing may be considered with blood flow studies or electrophysiologic testing. Special consideration is needed for children, for persons receiving extracorporeal membrane oxygenation, and for those receiving therapeutic hypothermia, as well as for factors such as religious, societal, and cultural perspectives; legal requirements; and resource availability. CONCLUSIONS AND RELEVANCE: This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries.

Long-term outcome following decompressive craniectomy: an inconvenient truth?

PURPOSE OF REVIEW: There is little doubt that decompressive craniectomy can reduce mortality following malignant middle cerebral infarction or severe traumatic brain injury. However, the concern has always been that the reduction in mortality comes at the cost of an increase in the number of survivors with severe neurological disability. RECENT FINDINGS: There has been a number of large multicentre randomized trials investigating surgical efficacy of the procedure. These trials have clearly demonstrated a survival benefit in those patients randomized to surgical decompression. However, it is only possible to demonstrate an improvement in outcome if the definition of favourable is changed such that it includes patients with either a modified Rankin score of 4 or upper severe disability. Without this recategorization, the results of these trials have confirmed the 'Inconvenient truth' that surgery reduces mortality at the expense of survival with severe disability. SUMMARY: Given these results, the time may have come for a nuanced examination of the value society places on an individual life, and the acceptability or otherwise of performing a procedure that converts death into survival with severe disability.

A study of the opinions of Swedish healthcare personnel regarding acceptable outcome following decompressive hemicraniectomy for ischaemic stroke.

BACKGROUND: Decompressive hemicraniectomy (DC) is an established lifesaving treatment for malignant infarction of the middle cerebral artery (mMCAI). However, surgical decompression will not reverse the effects of the stroke and many survivors will be left severely disabled. The objective of this study was to assess what neurological outcome would be considered acceptable in these circumstances amongst Swedish healthcare workers. METHOD: Healthcare workers were invited to participate in a presentation that outlined the pathophysiology of mMCAI, the rationale behind DC and outcome data from randomised controlled trials that have investigated efficacy of the procedure. They were then asked which neurological outcome would they feel to be acceptable based on the modified Rankin Score (mRS) and the Aphasia Handicap Scale (AHS). Information regarding sex, age, marital status, relatives, religion, earlier experience of stroke and occupation was also collected. RESULTS: Six hundred and nine persons participated. The median accepted mRS was 3. An mRS of 4 or 5 was perceived to be acceptable by only 30.5% of participants. Therefore the most likely outcome, based on the results of the randomised controlled trials, would be unacceptable to most of the participants [OR 0.39 (CI, 0.22-0.69)]. The median accepted AHS was 3. A worst language outcome of restricted autonomy of verbal communication (AHS 3) or better would be accepted by 44.6%. CONCLUSIONS: This study has highlighted the ethical problems when obtaining consent for DC following mMCAI, because for many of the participants the most likely neurological outcome would be deemed unacceptable. These issues need to be considered prior to surgical intervention and the time may have come for a broader societal discussion regarding the value of a procedure that converts death into survival with severe disability given the attendant financial and healthcare resource implications.

A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty: long-term follow-up.

OBJECTIVE: To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy. METHODS: Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year-with a minimum of 24-month follow-up. RESULTS: Amongst the 31 patients in the titanium group (one patient had died), no patients had a partial or complete cranioplasty failure at 12 months follow-up and there had been no failures beyond 12 months. Amongst the 31 patients who had an autologous cranioplasty (one patient had died), 7 patients had complete resorption of the autologous bone such that it was adjudged a complete failure at 12-month follow-up. Five of these patients had had titanium augmentation and two patients declined further surgery. Both of these patients requested cranial augmentation for functional and cosmetic reasons subsequent to the 12-month follow-up. Another patient who had previously been noted to have moderate resorption at 12 months presented 1 year later with progressive bone flap resorption and also required subsequent augmentation for functional and cosmetic reasons. When follow-up was extended to a minimum of 24 months, use of titanium instead of autologous bone for primary cranioplasty resulted in a significant reduction in the number of patients who required rescue cranioplasty (0 vs 25%, 95% confidence interval [CI] 9.1-42.1%; p = 0.001). In addition, there were significantly less total hospital healthcare costs in those patients randomised to the titanium arm of the trial (difference = A$9999, 95%CI 2231-17,768; p = 0.015). CONCLUSIONS: Bone resorption continued to occur beyond 12 months after autologous cranioplasty; use of primary titanium cranioplasty after decompressive craniectomy reduced the number of reoperations needed and the associated long-term total hospital costs.

Uncertainty, conflict and consent: revisiting the futility debate in neurotrauma.

The concept of futility has been debated for many years, and a precise definition remains elusive. This is not entirely unsurprising given the increasingly complex and evolving nature of modern medicine. Progressively more complex decisions are required when considering increasingly sophisticated diagnostic and therapeutic interventions. Allocating resources appropriately amongst a population whose expectations continue to increase raises a number of ethical issues not least of which are the difficulties encountered when consideration is being given to withholding "life-preserving" treatment. In this discussion we have used decompressive craniectomy for severe traumatic brain injury as a clinical example with which to frame an approach to the concept. We have defined those issues that initially lead us to consider futility and thereafter actually provoke a significant discussion. We contend that these issues are uncertainty, conflict and consent. We then examine recent scientific advances in outcome prediction that may address some of the uncertainty and perhaps help achieve consensus amongst stakeholders. Whilst we do not anticipate that this re-framing of the idea of futility is applicable to all medical situations, the approach to specify patient-centred benefit may assist those making such decisions when patients are incompetent to participate.

Cranioplasty: morbidity and failure.

OBJECTIVE: Cranioplasty is a technically straightforward procedure; however, it is becoming increasingly apparent that it is associated with relatively high morbidity and a significant failure rate due to either infection or autologous bone flap resorption. The aim of this study was to determine which factors influenced the incidence of cranioplasty complications and failure. METHODS: A retrospective analysis was undertaken of all patients who had a cranioplasty at the two major trauma hospitals in Western Australia between the start of 2004 and the middle of 2015. RESULTS: Five hundred and twelve had a cranioplasty after craniectomy for a variety of different indications. Sixty-three patients developed a postoperative intracranial collection following cranioplasty (12.3%, 95% confidence interval [CI] 9.7-15.4), however only 19 required surgical evacuation. One hundred and twenty-one patients had seizures following cranioplasty (23.6%, 95% CI 20.2-27.5) Nine patients died within six months following cranioplasty. Forty-two patients (8.2%, 95% CI 6.1-10.9) developed cranioplasty infection that necessitated removal of the implant. However a change in clinical management of these patients had led to no infections for the past three years. Amongst 330 patients who had autologous cranioplasty, clinically significant bone resorption occurred in 69 patients (20.9%, 95% CI 16.9-25.6). CONCLUSION: One key finding in this study is the reduction in infection rate that can occur when a single senior clinician performs the procedure and there is strict adherence to aseptic technique. This may result in a significant reduction in morbidity.

Long-term survival with unfavourable outcome: a qualitative and ethical analysis.

OBJECTIVE: To assess the issue of 'retrospective consent' among a cohort of patients who had survived with unfavourable outcome and to assess attitudes among next of kin regarding their role as surrogate decision makers. METHODS: Twenty patients who had survived for at least 3 years with an unfavourable outcome following a decompressive craniectomy for severe traumatic brain injury were assessed with their next of kin. During the course of a semistructured interview, participants were asked whether they would have provided consent if they had known their eventual outcome. They were also asked for general comments regarding all aspects of the clinical journey. Eighteen patients had next of kin who were available for interview. For two patients, there was no longer any family involvement. RESULTS: Of the 20 patients, 13 were able to provide a response and 11 felt that they would have provided consent even if they had known their eventual outcome. Of the 18 next of kin who were able to express an opinion, 10 felt that they would have provided retrospective consent. CONCLUSIONS: Many patients appeared to have adapted to a level of disability that competent individuals might deem unacceptable. This does not necessarily mean that such outcomes should be regarded as 'favourable', nor that decompressive craniectomy must be performed for patients with predicted poor outcome. Nevertheless, those burdened with the initial clinical decisions and thereafter the long-term care of these patients may draw some support from the knowledge that unfavourable may not necessarily be unacceptable.

Metastatic intradural primary spinal osteosarcoma: illustrative case.

BACKGROUND: Osteosarcomas are a common primary bone neoplasm among adolescents but represent 0.2% of all malignancies with an incidence of two to four cases per million persons annually worldwide. Although known to have significant metastatic potential, its rare incidence, treatment resistance, and poor prognosis have rendered it a poorly understood and infrequently documented pathology. OBSERVATIONS: Herein the authors present the first documented case of lumbosacral intradural metastasis of a primary osteosarcoma in a young patient, possibly via intradural dissemination following pinhole durotomy in a prior thoracic surgery. LESSONS: Osteosarcomas remain a difficult pathology to treat, particularly upon metastatic dissemination. The utility of adjuvant radiotherapy after resection of an osteosarcoma is increasingly evident in the reduction of local recurrence. In the context of intraoperative pinhole durotomies in resections of high-grade lesions, due consideration should be given to whole-spine radiation, although this remains an evidence-free zone.

A Prospective Cohort Study Characterizing Incidence of Dural Venous Sinus Thrombosis in Traumatic Brain Injury Patients with Skull Fractures.

BACKGROUND: Limited retrospective data suggest that dural venous sinus thrombosis (DVST) in traumatic brain injury (TBI) patients with skull fractures is common and associated with significant morbidity and mortality. Prospective data accurately characterizing the incidence of DVST in patients with high-risk TBI are sparse but are needed to develop evidence-based TBI management guidelines. METHODS: After obtaining institutional approval, 36 adult patients with TBI with skull fractures admitted to an Australian level III adult intensive care unit between April 2022 and January 2023 were prospectively recruited and underwent computed tomography venography or magnetic resonance venography within 72 hours of injury. When available, daily maximum intracranial pressure was recorded. RESULTS: Dural venous sinus abnormality was common (36.1%, 95% confidence interval 22.5%-52.4%) and strongly associated with DVST (P = 0.003). The incidence of DVST was 13.9% (95% confidence interval 6.1%-28.7%), which was lower than incidence reported in previous retrospective studies. Of DVSTs confirmed by computed tomography venography, 80% occurred in patients with extensive skull fractures including temporal or parietal bone fractures in conjunction with occipital bone fractures (P = 0.006). However, dural venous sinus abnormality and DVST were not associated with an increase in maximum daily intracranial pressure within the first 7 days after injury. CONCLUSIONS: Dural venous sinus abnormality was common in TBI patients with skull fractures requiring intensive care unit admission. DVST was confirmed in more than one third of these patients, especially patients with concomitant temporal or parietal and occipital bone fractures. Computed tomography venography is recommended for this subgroup of TBI patients.

Pre-treatment re-bleeding following aneurysmal subarachnoid hemorrhage: A systematic review of published prediction models with risk of bias and clinical applicability assessment.

BACKGROUND: Pre-treatment rebleeding following aneurysmal subarachnoid hemorrhage (aSAH) increases the risk of death and a poor neurological outcome. Current guidelines recommend aneurysm treatment "as early as feasible after presentation, preferably within 24 h of onset" to mitigate this risk, a practice termed ultra-early treatment. However, ongoing debate regarding whether ultra-early treatment is independently associated with reduced re-bleeding risk, together with the recognition that re-bleeding occurs even in centres practicing ultra-early treatment due to the presence of other risk-factors has resulted in a renewed need for patient-specific re-bleed risk prediction. Here, we systematically review models which seek to provide patient specific predictions of pre-treatment rebleeding risk. METHODS: Following registration on the International prospective register of systematic reviews (PROSPERO) CRD 42023421235; Ovid Medline (Pubmed), Embase and Googlescholar were searched for English language studies between 1st May 2002 and 1st June 2023 describing pre-treatment rebleed prediction models following aSAH in adults ≥18 years. Of 763 unique records, 17 full texts were scrutinised with 5 publications describing 4 models reviewed. We used the semi-automated template of Fernandez-Felix et al. incorporating the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist and the Prediction model Risk Of Bias ASsessment Tool (PROBAST) for data extraction, risk of bias and clinical applicability assessment. To further standardize risk of bias and clinical applicability assessment, we also used the published explanatory notes for the PROBAST tool and compared the aneurysm treatment practices each prediction model's formulation cohort experienced to a prespecified benchmark representative of contemporary aneurysm treatment practices as outlined in recent evidence-based guidelines and published practice pattern reports from four developed countries. RESULTS: Reported model discriminative performance varied between 0.77 and 0.939, however, no single model demonstrated a consistently low risk of bias and low concern for clinical applicability in all domains. Only the score of Darkwah Oppong et al. was formulated using a patient cohort in which the majority of patients were managed in accordance with contemporary, evidence-based aneurysm treatment practices defined by ultra-early and predominantly endovascular treatment. However, this model did not undergo calibration or clinical utility analysis and when applied to an external cohort, its discriminative performance was substantially lower that reported at formulation. CONCLUSIONS: No existing prediction model can be recommended for clinical use in centers practicing contemporary, evidence-based aneurysm treatment. There is a pressing need for improved prediction models to estimate and minimize pre-treatment re-bleeding risk.

Complications and consent following decompressive craniectomy: an illustrative case study.

PRIMARY OBJECTIVE: To assess clinical outcome following restoration of cranial contour in a young male who had suffered a severe traumatic brain injury. RESEARCH DESIGN: Case report. METHODS AND PROCEDURES: A young male was assessed before and after cranial reconstructive surgery with a custom-made titanium plate. The patient had previously required a bifrontal decompressive craniectomy in order to control intractable intracranial hypertension due to neurotrauma. Following an autologous cranioplasty he made very little neurological recovery and remained wheelchair-bound with severe contractures and was only able to follow single stage commands. Over the following 2 years he developed extensive resorption of his bone flap such that it required augmentation. MAIN OUTCOMES AND RESULTS: After surgery he clinically improved such that he was able to communicate more effectively and, although he remained severely disabled and fully dependent, he was able to communicate that he would have provided consent for the initial decompressive procedure even if he had known that the eventual outcome would be survival with severe disability and total dependence. CONCLUSIONS: Long-term follow-up is required for patients with severe traumatic brain injury not only to assess outcome and complications, but also to assess how acceptable that outcome is for the patient and their families.

The impact of cranioplasty on neurological function.

OBJECTIVES: To assess changes in neurological function after cranioplasty. METHODS: Functional and neurocognitive assessments including activities of daily living assessment, functional independence measure (FIM) and the Cognitive assessment report (COGNISTAT) were conducted on all patients within 72 h before and 7 days after cranioplasty. A change in the total FIM score of 2 points was taken to be clinically significant. RESULTS: Assessments were performed on 25 patients. The functional status was unchanged in eighteen patients (72%), four patients (16%) demonstrated a significant improvement and three patients (12%) deteriorated significantly. Those with deterioration after cranioplasty had some forms of complications including pneumocephalus or seizure. After excluding the three patients who had immediate medical or surgical complications after surgery, there was a mild overall improvement in the mean FIM score (2.1, 95% confidence interval 0.1-4.3, p = 0.049), mainly due to an improvement in their motor function. CONCLUSIONS: A small but significant number of patients appear to improve clinically following cranioplasty. The so-called syndrome of the trephined may be more common than had been previously appreciated.

Rebleeding following aneurysmal subarachnoid hemorrhage before 'endovascular first' treatment: a retrospective case-control study of published scoring systems.

BACKGROUND: Pre-treatment re-bleeding following aneurysmal subarachnoid hemorrhage (aSAH) affects up to 7.2% of patients even with ultra-early treatment within 24 hours. We retrospectively compared the utility of three published re-bleed prediction models and individual predictors between cases who re-bled matched to controls using size and parent vessel location from a cohort of patients treated in an ultra-early, 'endovascular first' manner. METHODS: On retrospective analysis of our 9-year cohort of 707 patients suffering 710 episodes of aSAH, there were 53 episodes of pre-treatment re-bleeding (7.5%). Forty-seven cases who had a single culprit aneurysm were matched to 141 controls. Demographic, clinical and radiological data were extracted and predictive scores calculated. Univariate, multivariate, area under the receiver operator characteristic curve (AUROCC) and Kaplan-Meier (KM) survival curve analyses were performed. RESULTS: The majority of patients (84%) were treated using endovascular techniques at a median 14.5 hours post-diagnosis. On AUROCC analysis the score of Liu et al. had minimal utility (C-statistic 0.553, 95% confidence interval (CI) 0.463 to 0.643) while the risk score of Oppong et al. (C-statistic 0.645 95% CI 0.558 to 0.732) and the ARISE-extended score of van Lieshout et al. (C-statistic 0.53 95% CI 0.562 to 0.744) had moderate utility. On multivariate modeling, the World Federation of Neurosurgical Societies (WFNS) grade was the most parsimonious predictor of re-bleeding (C-statistic 0.740, 95% CI 0.664 to 0.816). CONCLUSIONS: For aSAH patients treated in an ultra-early timeframe matched on size and parent vessel location, WFNS grade was superior to three published models for re-bleed prediction. Future re-bleed prediction models should incorporate the WFNS grade.

Standardizing Cranioplasty Outcomes Following Stroke or Traumatic Brain Injury: Protocol for the Development of a Core Outcome Set.

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.

Ethical considerations for performing decompressive craniectomy as a life-saving intervention for severe traumatic brain injury.

In all fields of clinical medicine, there is an increasing awareness that outcome must be assessed in terms of quality of life and cost effectiveness, rather than merely length of survival. This is especially the case when considering decompressive craniectomy for severe traumatic brain injury. The procedure itself is technically straightforward and involves temporarily removing a large section of the skull vault in order to provide extra space into which the injured brain can expand. A number of studies have demonstrated many patients going on to make a good long-term functional recovery, however, this is not always the case and a significant number survive but are left with severe neurocognitive impairment. Unfortunately, many of these patients are young adults who were previously fit and well and are, therefore, likely to spend many years in a condition that they may feel to be unacceptable, and this raises a number of ethical issues regarding consent and resource allocation. In an attempt to address these issues, we have used the analytical framework proposed by Jonsen, that requires systematic consideration of medical indications, patient preferences, quality of life and contextual features.

Syndrome of the trephined following bifrontal decompressive craniectomy: implications for rehabilitation.

OBJECTIVE: The syndrome of the trephined is a rare complication observed following a unilateral decompressive craniectomy for traumatic brain injury. What has not been previously reported is the occurrence of this complication following a bifrontal procedure. The objective of this study was to present two clinical cases that serve to highlight this condition. DESIGN: A case study of two patients who had had a bifrontal decompressive craniectomy for severe traumatic brain injury. METHOD: A review was undertaken detailing the clinical course of the two patients. RESULTS: Both cases were young males. They had initially made significant improvement in their functional and cognitive performance whilst undergoing rehabilitation. However, after some months they demonstrated marked deterioration. Immediately following cranioplasty they showed considerable clinical improvement. CONCLUSION: If the use of bifrontal decompressive craniectomies continues to increase it is important that those involved in the rehabilitation process are familiar with this rare condition. Early recognition is important so that patients can receive timely intervention and it also avoids valuable health resources being allocated to patients who cannot receive maximal benefit.