Inter-method reliability of the modified Rankin Scale in patients with subarachnoid hemorrhage

BACKGROUND AND OBJECTIVES: The modified Rankin Scale (mRS) is one of the most frequently used outcome measures in trials in patients with an aneurysmal subarachnoid hemorrhage (aSAH). The assessment method of the mRS is often not clearly described in trials, while the method used might influence the mRS score. The aim of this study is to evaluate the inter-method reliability of different assessment methods of the mRS. METHODS: This is a prospective, randomized, multicenter study with follow-up at 6 weeks and 6 months. Patients aged ≥ 18 years with aSAH were randomized to either a structured interview or a self-assessment of the mRS. Patients were seen by a physician who assigned an mRS score, followed by either the structured interview or the self-assessment. Inter-method reliability was assessed with the quadratic weighted kappa score and percentage of agreement. Assessment of feasibility of the self-assessment was done by a feasibility questionnaire. RESULTS: The quadratic weighted kappa was 0.60 between the assessment of the physician and structured interview and 0.56 between assessment of the physician and self-assessment. Percentage agreement was, respectively, 50.8 and 19.6%. The assessment of the mRS through a structured interview and by self-assessment resulted in systematically higher mRS scores than the mRS scored by the physician. Self-assessment of the mRS was proven feasible. DISCUSSION: The mRS scores obtained with different assessment methods differ significantly. The agreement between the scores is low, although the reliability between the assessment methods is good. This should be considered when using the mRS in clinical trials. TRIAL REGISTRATION: www.trialregister.nl; Unique identifier: NL7859. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-021-10880-4

Difference between brain temperature and core temperature in severe traumatic brain injury: a systematic review

INTRODUCTION: Intensive care management for TBI patients aims to prevent secondary cerebral damage. Targeted temperature management is one option to prevent cerebral damage, as hypothermia may have protective effects. By conducting a systematic literature review, we evaluated (1) the presence of a temperature difference (gradient) between brain temperature (Tb) and core temperature (Tc) in TBI patients and (2) clinical factors associated with reported differences. EVIDENCE ACQUISITION: The PubMed database was systematically searched using MESH terms and keywords, and Web of Sciences was assessed for additional article citations. We included studies that continuously and simultaneously measured Tb and Tc in severe TBI patients. The National Institutes of Health (NIH) quality assessment tool for observational cohort and cross-sectional studies was modified to fit the purpose of our study. Statistical data were extracted for further meta-analyses. EVIDENCE SYNTHESIS: We included 16 studies, with a total of 480 patients. Clinical heterogeneity consisted of Tb/Tc measurement site, measurement device, physiological changes, local protocols, and medical or surgical interventions. The studies have a high statistical heterogeneity (I2). The pooled mean temperature gradient between Tb and Tc was +0.14 °C (95% confidence interval: 0.03 to 0.24) and ranged from -1.29 to +1.1 °C. Patients who underwent a decompressive (hemi)craniectomy showed lower Tb values compared to Tc found in three studies. CONCLUSIONS: Studies on Tb and Tc are heterogeneous and show that, on average, Tb and Tc are not clinically significant different in TBI patients (<0.2 C). Interpretations and interventions of the brain and central temperatures will benefit from standardisation of temperature measurements

Visual field deficits after epilepsy surgery: a new quantitative scoring method

Anterior temporal lobectomy (ATL) as a treatment for drug-resistant temporal lobe epilepsy (TLE) frequently causes visual field deficits (VFDs). Reported VFD encompasses homonymous contralateral upper quadrantanopia. Its reported incidence ranges from 15 to 90%. To date, a quantitative method to evaluate postoperative VFD in static perimetry is not available. A method to quantify postoperative VFD, which allows for comparison between groups of patients, was developed. Fifty-five patients with drug-resistant TLE, who underwent ATL with pre- and postoperative perimetry, were included. Temporal lobe resection length was measured on postoperative MRI. Percentage VFD was calculated for the total visual field, contralateral upper quadrant, or other three quadrants combined. Patients were divided into groups by resection size (&lt; 45 and &lt;= 45 mm) and side of surgery (right and left). We found significant higher VFD in the &lt;= 45 vs. &lt; 45 mm group (2.3 +/- 4.4 vs. 0.7 +/- 2.4%,p = 0.04) for right-sided ATL. Comparing VFD in both eyes, we found more VFD in the right vs. left eye following left-sided ATL (14.5 +/- 9.8 vs. 12.9 +/- 8.3%, p = 0.03). We also demonstrated significantly more VFD in the &lt; 45 mm group for left- vs. right-sided surgery (6.7 +/- 6.7 vs. 13.1 +/- 7.0%, p = 0.016). A significant quantitative correlation between VFD and resection size for right-sided ATL was shown (r = 0.52, p &lt; 0.01). We developed a new quantitative scoring method for the assessment of postoperative visual field deficits after temporal lobe epilepsy surgery and assessed its feasibility for clinical use. A significant correlation between VFD and resection size for right-sided ATL was confirmed

Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial

Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. TBIicp patients were randomized to either the Brain Trauma Foundation (BTF) guideline CPP target range (control group) or to the individualized CA-guided CPP targets (intervention group). CPP targets were guided by six times daily software-based alerts for up to 5 days. The primary feasibility end-point was the percentage of time with CPP concordant (+/- 5 mm Hg) with the set CPP targets. The main secondary safety end-point was an increase in therapeutic intensity level (TIL) between the control and intervention group. Twenty-eight patients were randomized to the control and 32 patients to the intervention group. CPP in the intervention group was in the target range for 46.5% (interquartile range, 41.2-58) of the monitored time, significantly higher than the feasibility target specified in the published protocol (36%; p < 0.001). There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes

Study on prognosis of acutely ruptured intracranial aneurysms (SPARTA): a protocol for a multicentre prospective cohort study

Abstract Background Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical or endovascular treatment. Despite multiple previous studies, uncertainties on the optimal treatment practice still exists. The resulting treatment variation may result in a variable, potentially worse, patient outcome. To better inform future treatment strategies, this study aims to identify the effectiveness of different treatment strategies in patients with ruptured intracranial aneurysms by investigating long-term functional outcome, complications and cost-effectiveness. An explorative analysis of the diagnostic and prognostic value of radiological imaging will also be performed. Methods This multi-centre observational prospective cohort study will have a follow-up of 10 years. A total of 880 adult patients with a subarachnoid haemorrhage caused by a ruptured intracranial aneurysm will be included. Calculation of sample size (N = 880) was performed to show non-inferiority of clip-reconstruction compared to endovascular treatment on 1 year outcome, assessed by using the ordinal modified Rankin Scale. The primary endpoint is the modified Rankin Scale score and mortality at 1 year after the initial subarachnoid haemorrhage. Patients will receive ‘non-experimental’ regular care during their hospital stay. For this study, health questionnaires and functional outcome will be assessed at baseline, before discharge and at follow-up visits. Discussion Despite the major healthcare and societal burden, the optimal treatment strategy for patients with subarachnoid haemorrhage caused by ruptured intracranial aneurysms is yet to be determined. Findings of this comparative effectiveness study, in which in-between centre variation in practice and patient outcome are investigated, will provide evidence on the effectiveness of treatment strategies, hopefully contributing to future high value treatment standardisation. Trial registration number NCT05851989 Date of registration May 10th, 202

Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial.

Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. TBIicp patients were randomized to either the Brain Trauma Foundation (BTF) guideline CPP target range (control group) or to the individualized CA-guided CPP targets (intervention group). CPP targets were guided by six times daily software-based alerts for up to 5 days. The primary feasibility end-point was the percentage of time with CPP concordant (±5 mm Hg) with the set CPP targets. The main secondary safety end-point was an increase in therapeutic intensity level (TIL) between the control and intervention group. Twenty-eight patients were randomized to the control and 32 patients to the intervention group. CPP in the intervention group was in the target range for 46.5% (interquartile range, 41.2-58) of the monitored time, significantly higher than the feasibility target specified in the published protocol (36%; p < 0.001). There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes