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BACKGROUND The Timed Up and Go (TUG) test is the most commonly applied objective measure of functional impairment in patients with lumbar degenerative disc disease (DDD). OBJECTIVE To demonstrate external content validity of the TUG test. METHODS Consecutive adult patients, scheduled for elective lumbar spine surgery, were screened for enrollment into a prospective observational study. Disease severity was estimated by patient-reported outcome measures (PROMs; Visual Analog Scales [VAS], Core Outcome Measures Index [COMI] back, Zurich Claudication Questionnaire [ZCQ]) and the TUG test. Pearson correlation coefficients (PCCs) were used to describe the relationship between logarithmic TUG test raw values and PROMs. RESULTS A total of 70 patients (mean age 55.9 ± 15.4 yr; 38.6% female; 27.1% previous spine surgery; 28.6% lower extremity motor deficits) with lumbar disc herniation (50%), lumbar spinal stenosis (34.3%), or instability requiring spinal fusion (15.7%) were included. The mean TUG test time was 10.8 ± 4.4 s; age- and sex-adjusted objective functional impairment (OFI) T-score was 134.2 ± 36.9. A total of 12 (17.1%) patients had mild, 14 (20%) moderate, and 9 (12.9%) severe OFI, while 35 (50%) had TUG test results within the normal population range (no OFI). PCCs between TUG test time and VAS back pain were r = 0.37 (P = .002), VAS leg pain r = 0.37 (P = .002), COMI back r = 0.50 (P

The worldwide spread of smartphone usage enables new possibilities for longitudinal monitoring of objective functional impairment (OFI) in patients undergoing surgery for lumbar degenerative disc disease (DDD). Three patients, undergoing elective surgery for lumbar DDD, self-assessed OFI using a recently validated 6-min walking test (6WT) smartphone application. Results are presented as raw 6-min walking distance (6WD) as well as in reference to age- and sex-specific healthy population reference values using standardized z-scores (number of standard deviations). In parallel, patient-reported outcome measures (PROMs), including numeric rating scale (NRS) leg-pain and Core Outcome Measures Index (COMI) were obtained before (pre) and 6 weeks (6 W) as well as 3 months (3 M) after surgery. Descriptive analyses were used to compare PROMs with repeated 6WT measurements over time. The feasibility and benefits of the longitudinal OFI measurements using the 6WT app are discussed. One patient presented a favorable outcome, reflected by a clinically meaningful improvement in PROMs. Correspondingly, the 6WT distance gradually improved above the normal population values ((pre 399 m (z-score − 1.96) vs. 6 W 494 m (− 0.85) vs. 3 M 557 m (− 0.1)). One patient experienced initial improvement at 6 W, followed by a decline in 6WD at 3 M which promoted further interventions with subsequent recovery ((358 m (z-score − 3.29) vs 440 m (− 2.2) vs 431 m (− 2.32) vs 471 m (− 1.78)). The last patient showed a lack of improvement in PROMs as well as in OFI (360 m (z-score 0.0) vs 401 m (0.30) vs 345 m (− 0.11)) resulting in secondary surgery. The longitudinal assessment of OFI using the 6WT app was feasible and provided the physician with a detailed history of patients’ postoperative walking capacity complementing commonly used PROMs.

BACKGROUND Current prognostic tools in aneurysmal subarachnoid hemorrhage (aSAH) are constrained by being primarily based on patient and disease characteristics on admission. OBJECTIVE To develop and validate a complication- and treatment-aware outcome prediction tool in aSAH. METHODS This cohort study included data from an ongoing prospective nationwide multicenter registry on all aSAH patients in Switzerland (Swiss SOS [Swiss Study on aSAH]; 2009-2015). We trained supervised machine learning algorithms to predict a binary outcome at discharge (modified Rankin scale [mRS] ≤ 3: favorable; mRS 4-6: unfavorable). Clinical and radiological variables on admission ("Early" Model) as well as additional variables regarding secondary complications and disease management ("Late" Model) were used. Performance of both models was assessed by classification performance metrics on an out-of-sample test dataset. RESULTS Favorable functional outcome at discharge was observed in 1156 (62.0%) of 1866 patients. Both models scored a high accuracy of 75% to 76% on the test set. The "Late" outcome model outperformed the "Early" model with an area under the receiver operator characteristics curve (AUC) of 0.85 vs 0.79, corresponding to a specificity of 0.81 vs 0.70 and a sensitivity of 0.71 vs 0.79, respectively. CONCLUSION Both machine learning models show good discrimination and calibration confirmed on application to an internal test dataset of patients with a wide range of disease severity treated in different institutions within a nationwide registry. Our study indicates that the inclusion of variables reflecting the clinical course of the patient may lead to outcome predictions with superior predictive power compared to a model based on admission data only.

OBJECTIVEDigital transformation enables new possibilities to assess objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). This study examines the psychometric properties of an app-based 6-minute walking test (6WT) and determines OFI in patients with lumbar DDD.METHODSThe maximum 6-minute walking distance (6WD) was determined in patients with lumbar DDD. The results were expressed as raw 6WDs (in meters), as well as in standardized z-scores referenced to age- and sex-specific values of spine-healthy volunteers. The 6WT results were assessed for reliability and content validity using established disease-specific patient-reported outcome measures.RESULTSSeventy consecutive patients and 330 volunteers were enrolled. The mean 6WD was 370 m (SD 137 m) in patients with lumbar DDD. Significant correlations between 6WD and the Core Outcome Measures Index for the back (r = −0.31), Zurich Claudication Questionnaire (ZCQ) symptom severity (r = −0.32), ZCQ physical function (r = −0.33), visual analog scale (VAS) for back pain (r = −0.42), and VAS for leg pain (r = −0.32) were observed (all p < 0.05). The 6WT revealed good test-retest reliability (intraclass correlation coefficient 0.82), and the standard error of measurement was 58.3 m. A 4-tier severity stratification classified patients with z-scores > −1 (no OFI), −1 to −1.9 (mild OFI), −2 to −2.9 (moderate OFI), and ≤ −3 (severe OFI).CONCLUSIONSThe smartphone app-based self-measurement of the 6WT is a convenient, reliable, and valid way to determine OFI in patients with lumbar DDD. The 6WT app facilitates the digital evaluation and monitoring of patients with lumbar DDD.

Background Context Smartphone-based applications enable new prospects to monitor symptoms and assess functional outcome in patients with lumbar degenerative spinal disorders. However, little is known regarding patient acceptance and preference towards new modes of digital objective outcome assessment. Purpose To assess patient preference of an objective smartphone-based outcome measure compared to conventional paper-based subjective methods of outcome assessment. Study design Prospective observational cohort study. Patient sample Fourty-nine consecutive patients undergoing surgery for lumbar degenerative spinal disorder. Outcome measures Patients completed a preference survey to assess different methods of outcome assessment. A 5-level Likert scale ranged from strong disagreement (2 points) over neutral (6 points) to strong agreement (10 points) was used. Methods Patients self-determined their objective functional impairment using the 6-minute Walking Test application (6WT-app) and completed a set of paper-based patient-reported outcome measures (PROMs) before and 6 weeks after surgery. Patients were then asked to rate the methods of outcome assessment in terms of suitability, convenience, and responsiveness to their symptoms. Results The majority of patients considered the 6WT-app a suitable instrument (median 8.0, interquartile range [IQR] 4.0). Patients found the 6WT more convenient (median 10.0, IQR 2.0) than the Zurich Claudication Questionnaire (ZCQ; median 8.0, IQR 4.0, p=.019) and Core Outcome Measure Index (COMI; median 8.0, IQR 4.0, p=.007). There was good agreement that the 6WT-app detects change in physical performance (8.0, IQR 4.0). 78 % of patients considered the 6WT superior in detecting differences in symptoms (vs. 22% for PROMs). Seventy-six percent of patients would select the 6WT over the other, 18% the ZCQ and 6% the COMI. Eighty-two percent of patients indicated their preference to use a smartphone app for the assessment and monitoring of their spine-related symptoms in the future. Conclusions Patients included in this study favored the smartphone-based evaluation of objective functional impairment over paper-based PROMs. Involving patients more actively by means of digital technology may increase patient compliance and satisfaction as well as diagnostic accuracy.

Monitoring treatment response after chemotherapy of gadolinium-(Gd)-negative gliomas is challenging as conventional MRI often indicates no radiological changes. We hypothesize that 18F-FET-PET can be used as a biomarker for response assessment in Gd-negative gliomas undergoing chemotherapy. Sixty-one patients harboring Gd-negative WHO grade II or III glioma receiving alkylating agents (temozolomide or CCNU/procarbacine) were included. All patients underwent MRI and 18F-FET-PET before chemotherapy and 6 months later. We calculated T2-volume, 18F-FET-PET based biological tumour volume (BTV) and maximal tumour-to-brain ratio (TBRmax). Moreover, dynamic PET acquisition was performed using time-activity-curves (TACs) analysis. For MRI-based response assessment, RANO criteria for low-grade glioma were used. For 18F-FET-PET, following classification scheme was tested: responsive disease (RD) when a decrease in either BTV ≥ 25% and/or TBRmax ≥ 10% occurred, an increase in BTV ≥ 25% and/or TBRmax increase > 10% characterized progressive disease (PD), minor changes ± 25% for BTV and ± 10% for TBRmax were regarded as stable disease (SD). Post-chemotherapy survival (PCS) and time-to-treatment failure (TTF) were calculated using the Kaplan–Meier method. 18F-FET-PET based response has shown patients with RD to have the longest TTF time (78.5 vs 24.6 vs 24.1 months, p = 0.001), while there was no significant difference between patients with a SD and PD. A comparable pattern was observed for PCS (p

OBJECTIVEThe 6-minute walking test (6WT) is used to determine restrictions in a subject’s 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements.METHODSThe maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16–91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3–40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs.RESULTSThe ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87–0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7–597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001).CONCLUSIONSThis study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.

OBJECTIVEObjective functional measures such as the 6-minute walking test (6WT) are increasingly applied to evaluate patients with degenerative diseases of the lumbar spine before and after (surgical) treatment. However, the traditional 6WT is cumbersome to apply, as it requires specialized in-hospital infrastructure and personnel. The authors set out to compare 6-minute walking distance (6WD) measurements obtained with a newly developed smartphone application (app) and those obtained with the gold-standard distance wheel (DW).METHODSThe authors developed a free iOS- and Android-based smartphone app that allows patients to measure the 6WD in their home environment using global positioning system (GPS) coordinates. In a laboratory setting, the authors obtained 6WD measurements over a range of smartphone models, testing environments, and walking patterns and speeds. The main outcome was the relative measurement error (rME; in percent of 6WD), with |rME| < 7.5% defined as reliable. The intraclass correlation coefficient (ICC) for agreement between app- and DW-based 6WD was calculated.RESULTSMeasurements (n = 406) were reliable with all smartphone types in neighborhood, nature, and city environments (without high buildings), as well as with unspecified, straight, continuous, and stop-and-go walking patterns (ICC = 0.97, 95% CI 0.97–0.98, p < 0.001). Measurements were unreliable indoors, in city areas with high buildings, and for predominantly rectangular walking courses. Walking speed had an influence on the ME, with worse accuracy (2% higher rME) for every kilometer per hour slower walking pace (95% CI 1.4%–2.5%, p < 0.001). Mathematical adjustment of the app-based 6WD for velocity-dependent error mitigated the rME (p < 0.011), attenuated velocity dependence (p = 0.362), and had a positive effect on accuracy (ICC = 0.98, 95% CI 0.98–0.99, p < 0.001).CONCLUSIONSThe new, free, spine-specific 6WT smartphone app measures the 6WD conveniently by using GPS coordinates, empowering patients to independently determine their functional status before and after (surgical) treatment. Measurements of 6WD obtained for the target population under the recommended circumstances are highly reliable.

It remains difficult to estimate prolonged functional impairment in patients with chronic subdural hematoma (cSDH) treated with burr hole trepanation. We aim to establish a score that reliably predicts postoperative functional impairment.Retrospectively analysis of a prospective institutional database. cSDH patients operated in 2013-2016 were identified. Clinical outcome was dichotomized into presence (modified-Rankin-Scale (mRS) ≥ 2) or absence of functional impairment (mRS 0-1) at discharge and last follow-up. A score was developed, based on the effect sizes of a set of outcome predictors. Its accuracy was tested using Area Under the Receiver-Operating Characteristic (AUROC) curve analysis. The 2017 cohort served for internal validation.A cohort of 253 patients (mean age 75 years, 75% male) was analyzed, of which 77 patients (30%) remained functionally impaired. In multivariate analysis, severe motor deficits at admission (OR 5.84, 95% CI 2.71-12.59, p 0.001), age (≥85 years: 5.53, 2.14-14.32, p 0.0001) and disorientation at admission (2.65, 11.39-5.05, p = 0.003) were associated with persistent functional impairment. Based on those variables, we created the "Functional Impairment after burr hole Trepanation" (FIT-score), which showed an AUROC of 0.77 (95% CI 0.70-0.83) for impairment at discharge and 0.76 (0.70-0.82) for impairment at follow-up. Internal validation confirmed the model with an AUROC of 0.79 (0.68-0.91) at discharge and 0.77 (0.64-91) at follow-up.The FIT-score is likely to assist the physician when counseling patients and relatives pertaining to the need for postoperative rehabilitation and mid- to long-term supportive home care.

There is a paucity of data concerning the safety and efficacy of surgical education for neurosurgical residents in the evacuation of chronic subdural hematomas (cSDH) by burr hole trepanation. This is a retrospective analysis of prospectively collected data on consecutive patients receiving burr hole trepanation for uni- or bilateral cSDH. Patients operated by a supervised neurosurgery resident (teaching cases) were compared to patients operated by a board-certified faculty neurosurgeon (BCFN; non-teaching cases). The primary endpoint was surgical revision for any reason until the last follow-up. The secondary endpoint was occurrence of any complication until the last follow-up. Clinical status, type of complications, mortality, length of surgery (LOS), and hospitalization (LOH) were tertiary endpoints. A total of n = 253 cases were analyzed, of which n = 217 (85.8%) were teaching and n = 36 (14.2%) non-teaching cases. The study groups were balanced in terms of age, sex, surgical risk (ASA score), and preoperative status (Karnofsky Performance Scale (KPS), modified Rankin Scale (mRS), National Institute of Health Stroke Scale (NIHSS)). The cohort was followed for a mean of 242 days (standard deviation 302). In multivariate analysis, teaching cases were as likely as non-teaching cases to require revision surgery (OR 0.65, 95% CI 0.27–1.59; p = 0.348) as well as to experience any complication until the last follow-up (OR 0.79, 95% CI 0.37–1.67; p = 0.532). Mean LOS was about 10 min longer in teaching cases (53.0 ± 26.1 min vs. 43.5 ± 17.8 min; p = 0.036), but LOH was similar. There were no group differences in clinical status, mortality and type of complication at discharge, and the last follow-up. Burr hole trepanation for cSDH can be safely performed by supervised neurosurgical residents enrolled in a structured training program, without increasing the risk for revision surgery, perioperative complications, or worse outcome.