Multicenter external validation of prediction models for clinical outcomes after spinal fusion for lumbar degenerative disease.

BACKGROUND: Clinical prediction models (CPM), such as the SCOAP-CERTAIN tool, can be utilized to enhance decision-making for lumbar spinal fusion surgery by providing quantitative estimates of outcomes, aiding surgeons in assessing potential benefits and risks for each individual patient. External validation is crucial in CPM to assess generalizability beyond the initial dataset. This ensures performance in diverse populations, reliability and real-world applicability of the results. Therefore, we externally validated the tool for predictability of improvement in oswestry disability index (ODI), back and leg pain (BP, LP). METHODS: Prospective and retrospective data from multicenter registry was obtained. As outcome measure minimum clinically important change was chosen for ODI with ≥ 15-point and ≥ 2-point reduction for numeric rating scales (NRS) for BP and LP 12 months after lumbar fusion for degenerative disease. We externally validate this tool by calculating discrimination and calibration metrics such as intercept, slope, Brier Score, expected/observed ratio, Hosmer-Lemeshow (HL), AUC, sensitivity and specificity. RESULTS: We included 1115 patients, average age 60.8 ± 12.5 years. For 12-month ODI, area-under-the-curve (AUC) was 0.70, the calibration intercept and slope were 1.01 and 0.84, respectively. For NRS BP, AUC was 0.72, with calibration intercept of 0.97 and slope of 0.87. For NRS LP, AUC was 0.70, with calibration intercept of 0.04 and slope of 0.72. Sensitivity ranged from 0.63 to 0.96, while specificity ranged from 0.15 to 0.68. Lack of fit was found for all three models based on HL testing. CONCLUSIONS: Utilizing data from a multinational registry, we externally validate the SCOAP-CERTAIN prediction tool. The model demonstrated fair discrimination and calibration of predicted probabilities, necessitating caution in applying it in clinical practice. We suggest that future CPMs focus on predicting longer-term prognosis for this patient population, emphasizing the significance of robust calibration and thorough reporting.

The role of the craniotomy size in the surgical evacuation of acute subdural hematomas in elderly patients: a retrospective multicentric study.

BACKGROUND: Elderly patients operated for an acute subdural hematoma (ASDH) frequently have a poor outcome, with a high frequency of death, vegetative status, or severe disability (Glasgow Outcome Score, GOS, 1-3). Minicraniotomy has been proposed as a minimally invasive surgical treatment to reduce the impact of surgery in the elderly population. The present study aimed to compare the influence of the size of the craniotomy on the functional outcome in patients undergoing surgical treatment for ASDH. METHODS: We selected patients ≥70 years old admitted to 5 Italian tertiary referral neurosurgical for the treatment of a post-traumatic ASDH between January 1st 2016 and December 31st 2019. We collected demographic data, clinical data (GCS, GOS, Charlson Comorbidity Index-CCI, antiplatelet/anticoagulant therapy, neurological deficits, seizure, pupillary size, length of stay), surgical data (craniotomy size, dividing the patients into 3 groups based on the corresponding tertile, and surgery duration), radiological data (ASDH side and thickness, midline shift, other post-traumatic lesions, extent of ASDH evacuation) and we assessed the functional outcome at hospital discharge and 6-month follow-up considering GOS=1-3 as a poor outcome. ANOVA and Chi-squared tests and logistic regression models were used to assess differences in and associations between clinicalradiological characteristics and functional outcomes. RESULTS: We included 136 patients (76 males) with a mean age of 78±6 years. Forty-five patients underwent a small craniotomy, 47 a medium size, and 44 a large craniotomy. Among the different craniotomy size groups, there were no differences in gender, anticoagulant/antithrombotic therapy, CCI, side of ASDH, ASDH thickness, preoperative GCS, focal deficits, seizures, and presence of other posttraumatic lesions. Patients undergoing small craniotomies were older than patients undergoing medium-large craniotomies; ASDH treated with medium size craniotomy were thinner than the others; patients undergoing large craniotomies showed greater midline shift and a higher rate of anisocoria. The three groups did not differ for functional outcome and postoperative midline shift, but the length of surgery and the rate of >50% of ASDH evacuation were lower in the small craniotomy group. CONCLUSIONS: A small craniotomy was not inferior to larger craniotomies in determining functional outcomes in the treatment of ASDH in the elderly.

FUSE-ML: development and external validation of a clinical prediction model for mid-term outcomes after lumbar spinal fusion for degenerative disease.

BACKGROUND: Indications and outcomes in lumbar spinal fusion for degenerative disease are notoriously heterogenous. Selected subsets of patients show remarkable benefit. However, their objective identification is often difficult. Decision-making may be improved with reliable prediction of long-term outcomes for each individual patient, improving patient selection and avoiding ineffective procedures. METHODS: Clinical prediction models for long-term functional impairment [Oswestry Disability Index (ODI) or Core Outcome Measures Index (COMI)], back pain, and leg pain after lumbar fusion for degenerative disease were developed. Achievement of the minimum clinically important difference at 12 months postoperatively was defined as a reduction from baseline of at least 15 points for ODI, 2.2 points for COMI, or 2 points for pain severity. RESULTS: Models were developed and integrated into a web-app ( https://neurosurgery.shinyapps.io/fuseml/ ) based on a multinational cohort [N = 817; 42.7% male; mean (SD) age: 61.19 (12.36) years]. At external validation [N = 298; 35.6% male; mean (SD) age: 59.73 (12.64) years], areas under the curves for functional impairment [0.67, 95% confidence interval (CI): 0.59-0.74], back pain (0.72, 95%CI: 0.64-0.79), and leg pain (0.64, 95%CI: 0.54-0.73) demonstrated moderate ability to identify patients who are likely to benefit from surgery. Models demonstrated fair calibration of the predicted probabilities. CONCLUSIONS: Outcomes after lumbar spinal fusion for degenerative disease remain difficult to predict. Although assistive clinical prediction models can help in quantifying potential benefits of surgery and the externally validated FUSE-ML tool may aid in individualized risk-benefit estimation, truly impacting clinical practice in the era of "personalized medicine" necessitates more robust tools in this patient population.

Influence of nutritional status on the clinical outcome of patients with chronic subdural hematoma: a prospective multicenter clinical study.

BACKGROUND: Elderly patients present a higher risk of developing chronic subdural hematomas (CSDHs) together with increased risk of malnutrition. The nutritional status may affect outcomes, response to treatments, and prognosis. Influence on other kinds of diseases was investigated showing an increased risk of mortality, morbidity, and adverse outcomes. However, no studies are available on its possible role for the outcome of patients with CSDH. This study aims to evaluate a possible relationship between the nutritional status and the clinical outcome of patients who underwent CSDH surgery. METHODS: This is a multicenter prospective study enrolling all patients treated for CSDH. Demographic and clinical data were collected. For nutritional status evaluation, we used the Mini Nutritional Assessment (MNA). Chi-square test was used for comparing clinical variables of patients and logistic regression analysis was used for defining the impact of the aforementioned variables on the clinical outcome. RESULTS: We enrolled 178 patients. Modified Rankin scale (mRS) was 0-2 pre-operatively in 23.6% of patients and post-operatively in 61.2% of patients. Total assessment MNA score was >23.5 in 47.8% of patients. Ninety-three patients (52.2%) presented a normal nutritional status, 63 (35.4%) were at risk of malnutrition and 22 (12.4%) were malnourished. The mean follow-up was 2.6 months. Malnourished patients were at higher risk of a worse outcome (OR 81; CI = 9-750). CONCLUSION: This study suggests that nutritional status represents a strong predictor of outcome. Our results, albeit preliminary, demonstrated malnutrition is correlated to the risk of worse clinical outcome for patients undergoing surgery for chronic subdural hematoma. Further investigations with wider casuistry and multiple nutritional scores are required to validate our data.

Incidence of hemorrhagic cerebrovascular disease due to vascular malformations during the COVID-19 national quarantine in Italy.

BACKGROUND: hemorrhagic cerebrovascular disease due to vascular malformations represents an emergency for neurosurgery and neuro-interventional departments. During the COVID-19 pandemic, a dramatic reduction in the number of hospitalizations for acute myocardial infarction or stroke and a larger time interval from symptom onset to first medical contact have been reported. This study aims to verify the hypothesis that there would also have been a reduction of admissions for hemorrhagic cerebrovascular disease during the Italian lockdown. MATERIAL AND METHOD: s A multicenter, observational survey was conducted to collect data on hospital admissions for hemorrhagic cerebrovascular disease due to vascular malformations throughout two-months (March 15th to May 15th); the years 2020 (COVID-19 Italian lockdown), 2019 and 2018 were compared. Cases were identified by ICD-9 codes 430, 431, 432.1, 432.9, 747.81 of each hospital database. The statistical significance of the difference between the event rate of one year versus the others was evaluated using Poisson Means test, assuming a constant population. RESULTS: During the 2020 lockdown, the total number of admissions for hemorrhagic cerebrovascular disease was 92 compared with 116 in 2019 and 95 in 2018. This difference was not significant. GCS upon admission was 3-8 in 44 % of cases in 2020 (41 patients), 39.7 % in 2019 (46 patients) and 28 % in 2018 (27 patients). CONCLUSION: Reduction of admissions for hemorrhagic cerebrovascular disease due to vascular malformations during the COVID-19 lockdown was not confirmed. Nevertheless, some patients reached the emergency rooms only several days after symptoms onset, resulting in a worse clinical condition at admission.