Expanding the indications for measurement of objective functional impairment in spine surgery: A pilot study of four patients with diseases affecting the spinal cord.

•The TUG test and the 6WT are feasible to apply in ambulatory patients with spinal cord affection.•The objective measurement of functional impairment resembled the functional status of four patients in this pilot study.•The TUG test and the 6WT may detect and quantify functional decline and/or improvement resulting from spinal cord affection.•Modern smartphone app-based technology may help to accurately quantify impairment, which is key for decision-making and evaluating the efficacy of interventions.

Distance to first symptoms measured by the 6-min walking test differentiates between treatment success and failure in patients with degenerative lumbar disorders.

PURPOSE: The smartphone-based 6-min walking test (6WT) is an established digital outcome measure in patients undergoing surgery for degenerative lumbar disorders (DLD). In addition to the 6WTs primary outcome measure, the 6-min walking distance (6WD), the patient's distance to first symptoms (DTFS) and time to first symptoms (TTFS) can be recorded. This is the first study to analyse the psychometric properties of the DTFS and TTFS. METHODS: Forty-nine consecutive patients (55 ± 15.8 years) completed the 6WT pre- and 6 weeks (W6) postoperative. DTFS and TTFS were assessed for reliability and content validity using disease-specific patient-reported outcome measures. The Zurich Claudication Questionnaire patient satisfaction subscale was used as external criterion for treatment success. Internal and external responsiveness for both measures at W6 was evaluated. RESULTS: There was a significant improvement in DTFS and TTFS from baseline to W6 (p < 0.001). Both measures demonstrated a good test-retest reliability (ß = 0.86, 95% CI 0.81-0.90 and ß = 0.83, 95% CI 0.76-0.87, both p < 0.001). The DTFS exceeded the 6WD capability to differentiate between satisfied (82%) and unsatisfied patients (18%) with an AUC of 0.75 (95% CI 0.53-0.98) vs. 0.70 (95% CI 0.52-0.90). The TTFS did not demonstrate meaningful discriminative abilities. CONCLUSION: Change in DTFS can differentiate between satisfied and unsatisfied patients after spine surgery. Digital outcome measures on the 6WT metric provide spine surgeons and researchers with a mean to assess their patient's functional disability and response to surgical treatment in DLD.

Association of Medical Comorbidities With Objective Functional Impairment in Lumbar Degenerative Disc Disease.

STUDY DESIGN: Analysis of a prospective 2-center database. OBJECTIVES: Medical comorbidities co-determine clinical outcome. Objective functional impairment (OFI) provides a supplementary dimension of patient assessment. We set out to study whether comorbidities are associated with the presence and degree of OFI in this patient population. METHODS: Patients with degenerative diseases of the spine preoperatively performed the timed-up-and-go (TUG) test and a battery of questionnaires. Comorbidities were quantified using the Charlson Comorbidity Index (CCI) and the American Society of Anesthesiology (ASA) grading. Crude and adjusted linear regression models were fitted. RESULTS: Of 375 included patients, 97 (25.9%) presented at least some degree of medical comorbidity according to the CCI, and 312 (83.2%) according to ASA grading. In the univariate analysis, the CCI was inconsistently associated with OFI. Only patients with low-grade CCI comorbidity displayed significantly higher TUG test times (p = 0.004). In the multivariable analysis, this effect persisted for patients with CCI = 1 (p = 0.030). Regarding ASA grade, patients with ASA = 3 exhibited significantly increased TUG test times (p = 0.003) and t-scores (p = 0.015). This effect disappeared after multivariable adjustment (p = 0.786 and p = 0.969). In addition, subjective functional impairment according to ODI, and EQ5D index was moderately associated with comorbidities according to ASA (all p < 0.05). CONCLUSION: The degree of medical comorbidities appears only weakly and inconsistently associated with OFI in patients scheduled for degenerative lumbar spine surgery, especially after controlling for potential confounders. TUG testing may be valid even in patients with relatively severe comorbidities who are able to complete the test.

External Validation of the Minimum Clinically Important Difference in the Timed-up-and-go Test After Surgery for Lumbar Degenerative Disc Disease.

STUDY DESIGN: Prospective observational cohort study. OBJECTIVE: The aim of this study was to provide external validation of the minimum clinically important difference (MCID) of the Timed-up-and-go (TUG) test. SUMMARY OF BACKGROUND DATA: The TUG test is one of the best explored and most frequently applied objective task-based functional outcome measure in patients with lumbar degenerative disc disease (DDD). The increased use of the TUG test is based on its solid psychometric properties; however, an external validation of the originally determined MCID is lacking. METHODS: Forty-nine patients with lumbar DDD, scheduled for elective spine surgery, were assessed pre- and 6-weeks (W6) postoperative. MCID values were calculate for raw TUG test times (seconds) and standardized TUG z scores using three different computation methods and the following established patient-reported outcome measures (PROMs) as anchors: Visual Analog Scales (VAS), Core Outcome Measures Index Back, Zurich Claudication Questionnaire (ZCQ). RESULTS: The three computation methods generated a range of MCID values, depending on the PROM used as anchor, from 0.9 s (z score of 0.3) based on the VAS leg pain to 3.0 seconds (z score of 2.7) based on the ZCQ physical function scale. The average MCID of the TUG test across all anchors and computation methods was 2.1 s (z score of 1.5). According to the average MCID of raw TUG test values or TUG z scores, 41% and 43% of patients classified as W6 responders to surgery, respectively. CONCLUSION: This study confirms the ordinally reported TUG MCID values in patients undergoing surgery for lumbar. A TUG test time change of 2.1 seconds (or TUG z score change of 1.5) indicates an objective and clinically meaningful change in functional status. This report facilitates the interpretation of TUG test results in clinical routine as well as in research.Level of Evidence: 3.

Responsiveness of the self-measured 6-minute walking test and the Timed Up and Go test in patients with degenerative lumbar disorders.

OBJECTIVE: The 6-minute walking test (6WT) and the Timed Up and Go (TUG) test are two of the most commonly applied standardized measures of objective functional impairment that help support clinical decision-making for patients undergoing surgery for degenerative lumbar disorders. This study correlates smartphone-app-based 6WT and TUG results to evaluate their responsiveness. METHODS: In a prospective study, 49 consecutive patients were assessed preoperatively and 6 weeks postoperatively using the 6WT, the TUG test, and commonly used patient-reported outcome measures. Raw values and standardized z-scores of both objective tests were correlated. An external criterion for treatment success was created based on the Zurich Claudication Questionnaire patient satisfaction subscale. Internal and external responsiveness for both functional tests was evaluated. RESULTS: The mean preoperative 6WT results improved from 401 m (SD 129 m), z-score -1.65 (SD 1.6) to 495 m (SD 129 m), z-score -0.71 (SD 1.6, p < 0.001). The mean preoperative TUG test results improved from 10.44 seconds (SD 4.37, z-score: -3.22) to 8.47 seconds (SD 3.38, z-score: -1.93, p < 0.001). The 6WT showed a strong negative correlation with TUG test results (r = -66, 95% CI 0.76-0.53, p < 0.001). The 6WT showed higher internal responsiveness (standardized responsive mean = 0.86) compared to the TUG test (standardized responsive mean = 0.67). Evaluation of external responsiveness revealed that the 6WT was capable of differentiating between patients who were satisfied and those who were unsatisfied with their treatment results (area under the curve = 0.70), whereas this was not evident for the TUG test ( area under the curve = 0.53). CONCLUSIONS: Both tests adequately quantified functional impairment in surgical candidates with degenerative lumbar disorders. The 6WT demonstrated better internal and external responsiveness compared with the TUG test. Clinical trial registration no.: NCT03977961 (clinicaltrials.gov). ABBREVIATIONS: AUC = area under the curve; COMI = Core Outcome Measures Index; DLDs = degenerative lumbar disorders; LDH = lumbar disc herniation; LSS = lumbar spinal stenosis; PROM = patient-reported outcome measure; ROC = receiver operating characteristic; SRM = standardized responsive mean; TUG = Timed Up and Go; VAS = visual analog scale; 6WD = 6-minute walking distance; 6WT = 6-minute walking test; ZCQ = Zurich Claudication Questionnaire.

Patients undergoing surgery for lumbar degenerative spinal disorders favor smartphone-based objective self-assessment over paper-based patient-reported outcome measures.

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.

External Validation of the Timed Up and Go Test as Measure of Objective Functional Impairment in Patients With Lumbar Degenerative Disc Disease.

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 < .001), ZCQ symptom severity r = 0.41 (P < .001), and ZCQ physical function r = 0.36 (P = .002). CONCLUSION: This external validation demonstrated similar OFI rates and PCCs between logarithmic TUG test results and PROMs compared to the original article from 2016. These findings support the TUG test being a quick, easy-to-use objective test, which provides the physician with a robust estimate of pain and functional impairment.

Evaluation of the 6-minute walking test as a smartphone app-based self-measurement of objective functional impairment in patients with lumbar degenerative disc disease.

OBJECTIVE: Digital 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. METHODS: The 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. RESULTS: Seventy 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). CONCLUSIONS: The 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.

Longitudinal smartphone-based self-assessment of objective functional impairment in patients undergoing surgery for lumbar degenerative disc disease: initial experience.

BACKGROUND: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Normative data of a smartphone app-based 6-minute walking test, test-retest reliability, and content validity with patient-reported outcome measures.

OBJECTIVE: The 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. METHODS: The 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. RESULTS: The 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). CONCLUSIONS: This 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.

Smartphone-Based Self-Assessment of Objective Functional Impairment (6-Minute Walking Test) in Patients Undergoing Epidural Steroid Injection.

Epidural steroid injection (ESI) represents a popular treatment option in patients with lumbar degenerative disc disease (DDD). The main objective of the article was to determine whether the 6-minute walking test (6WT) could assist in the discrimination between ESI responders and nonresponders. We used a validated 6WT smartphone application to assess self-measured objective functional impairment (OFI) in 3 patients with DDD undergoing ESI. Patient-reported outcome measures (PROMs), including the Core Outcome Measures Index and the Oswestry Disability Index, were obtained at baseline and at the 3-, 7-, and 28-day follow-up. Descriptive analyses were used to compare PROMs with OFI over time. Two patients responded well to the ESI, illustrated by clinically meaningful improvements in PROMs. This improvement was accompanied by a substantial increase in the 6WT distance (case I: 358 m vs. 517 m and case II: 296 m vs. 625 m). One patient reported only moderate improvement in leg pain and conflicting results in the other PROMs. The 6WT demonstrated a persistent OFI (487 m vs. 488 m). This patient was considered a nonresponder and underwent surgical treatment. This case series illustrates the feasibility of the smartphone-based 6WT as a tool to assess OFI in patients undergoing ESI for lumbar DDD.

Reliability of the 6-minute walking test smartphone application.

OBJECTIVE: Objective 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). METHODS: The 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. RESULTS: Measurements (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). CONCLUSIONS: The 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.

Association of single and multiple aneurysms with tobacco abuse: an @neurIST risk analysis.

OBJECTIVE: Although several studies have suggested that the incidence of intracranial aneurysms (IAs) is higher in smokers, the higher prevalence of subarachnoid hemorrhage (SAH) in smokers remains uncertain. It is unclear whether smoking additionally contributes to the formation of multiple aneurysms and the risk of rupture. The aim of this study was to determine whether smoking is associated with IA formation, multiplicity, or rupture. METHODS: Patients from the prospective multicenter @neurIST database (n = 1410; 985 females [69.9%]) were reviewed for the presence of SAH, multiple aneurysms, and smoking status. The prevalence of smokers in the population of patients diagnosed with at least one IA was compared with that of smokers in the general population. RESULTS: The proportion of smokers was higher in patients with IAs (56.2%) than in the reference population (51.4%; p < 0.001). A significant association of smoking with the presence of an IA was found throughout group comparisons (p = 0.01). The presence of multiple IAs was also significantly associated with smoking (p = 0.003). A trend was found between duration of smoking and the presence of multiple IAs (p = 0.057). However, the proportion of smokers among patients suffering SAH was similar to that of smokers among patients diagnosed with unruptured IAs (p = 0.48). CONCLUSIONS: Smoking is strongly associated with IA formation. Once an IA is present, however, smoking does not appear to increase the risk of rupture compared with IAs in the nonsmoking population. The trend toward an association between duration of smoking and the presence of multiple IAs stresses the need for counseling patients with IAs regarding lifestyle modification.

Objective functional assessment using the "Timed Up and Go" test in patients with lumbar spinal stenosis.

OBJECTIVEPatient-reported outcome measures (PROMs) are standard of care for the assessment of functional impairment. Subjective outcome measures are increasingly complemented by objective ones, such as the "Timed Up and Go" (TUG) test. Currently, only a few studies report pre- and postoperative TUG test assessments in patients with lumbar spinal stenosis (LSS).METHODSA prospective two-center database was reviewed to identify patients with LSS who underwent lumbar decompression with or without fusion. The subjective functional status was estimated using PROMs for pain (visual analog scale [VAS]), disability (Roland-Morris Disability Index [RMDI] and Oswestry Disability Index [ODI]), and health-related quality of life (HRQoL; 12-Item Short-Form Physical Component Summary [SF-12 PCS] and the EQ-5D) preoperatively, as well as on postoperative day 3 (D3) and week 6 (W6). Objective functional impairment (OFI) was measured using age- and sex-standardized TUG test results.RESULTSSixty-four patients (n = 32 [50%] male, mean age 66.8 ± 11.7 years) were included. Preoperatively, they reported a mean VAS back pain score of 4.1 ± 2.7, VAS leg pain score of 5.4 ± 2.7, RMDI of 10.4 ± 5.3, ODI of 41.9 ± 16.2, SF-12 PCS score of 32.7 ± 8.3, and an EQ-5D index of 0.517 ± 0.226. The preoperative rates of severe, moderate, and mild OFI were 4.7% (n = 3), 12.5% (n = 8), and 7.8% (n = 5), respectively, and the mean OFI T-score was 116.3 ± 23.7. At W6, 60 (93.8%) of 64 patients had a TUG test result within the normal population range (no OFI); 3 patients (4.7%) had mild and 1 patient (1.6%) severe OFI. The mean W6 OFI T-score was significantly decreased (103.1 ± 13.6; p < 0.001). Correspondingly, the PROMs showed a decrease in subjective VAS back pain (1.6 ± 1.7, p < 0.001) and leg pain (1.0 ± 1.8, p < 0.001) scores, disability (RMDI 5.3 ± 4.7, p < 0.001; ODI 21.3 ± 16.1, p < 0.001), and increase in HRQoL (SF-12 PCS 40.1 ± 8.3, p < 0.001; EQ-5D 0.737 ± 0.192, p < 0.001) at W6. The W6 responder status (clinically meaningful improvement) ranged between 81.3% (VAS leg pain) and 29.7% (EQ-5D index) of patients.CONCLUSIONSThe TUG test is a quick and easily applicable tool that reliably measures OFI in patients with LSS. Objective tests incorporating longer walking time should be considered if OFI is suspected but fails to be proven by the TUG test, taking into account that neurogenic claudication may not clinically manifest during the brief TUG examination. Objective tests do not replace the subjective PROM-based assessment, but add valuable information to a comprehensive patient evaluation.

Objective measures of functional impairment for degenerative diseases of the lumbar spine: a systematic review of the literature.

BACKGROUND CONTEXT: The accurate determination of a patient's functional status is necessary for therapeutic decision-making and to critically appraise treatment efficacy. Current subjective patient-reported outcome measure (PROM)-based assessments have limitations and can be complimented by objective measures of function. PURPOSE: To systematically review the literature and provide an overview on the available objective measures of function for patients with degenerative diseases of the lumbar spine. STUDY DESIGN/SETTING: Systematic review of the literature. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Two reviewers independently searched the PubMed, Web of Science, EMBASE, and SCOPUS databases for permutations of the words "objective," "assessment," "function," "lumbar," and "spine" including articles on human subjects with degenerative diseases of the lumbar spine that reported on objective measures of function, published until September 2018. Risk of bias was not assessed. No funding was received. The authors report no conflicts of interest. RESULTS: Of 2,389 identified articles, 82 were included in the final analysis. There was a significant increase of 0.12 per year in the number of publications dealing with objective measures of function since 1989 (95% CI 0.08-0.16, p<.001). Some publications studied multiple diagnoses and objective measures. The United States was the leading nation in terms of scientific output for objective outcome measures (n=21; 25.6%), followed by Switzerland (n=17; 20.7%), Canada, Germany, and the United Kingdom (each n=6; 7.3%). Our search revealed 21 different types of objective measures, predominantly applied to patients with lumbar spinal stenosis (n=67 publications; 81.7%), chronic/unspecific low back pain (n=28; 34.2%) and lumbar disc herniation (n=22; 26.8%). The Timed-Up-and-Go test was the most frequently applied measure (n=26 publications; 31.7%; cumulative number of reported subjects: 5,181), followed by the Motorized Treadmill Test (n=25 publications; 30.5%, 1,499 subjects) and with each n=9 publications (11.0%) the Five-Repetition Sit-To-Stand test (955 subjects), as well as accelerometry analyses (336 subjects). The reliability and validity of many of the less-applied objective measures was uncertain. There was profound heterogeneity in their application and interpretation of results. CONCLUSIONS: Clinical studies on patients with lumbar degenerative diseases increasingly employ objective measures of function, which offer high potential for improving the quality of outcome measurement in patient-care and research. This review provides an overview on available options. Our findings call for an agreement and standardization in terms of test selection, conduction and analysis to facilitate comparison of results across cohorts. PROSPERO REGISTRATION NUMBER: CRD42019122622.

Effect of mono- or bisegmental lordosizing fusion on short-term global and index sagittal balance: a radiographic study.

BACKGROUND: Sagittal balance is widely recognized as an important outcome factor in reconstructive spinal surgery for lumbar degenerative conditions. However, its role in short segmental fixation is unknown. The aim of this study was to evaluate the preoperative and short-term postoperative spino-pelvic balance after short (1 or 2 levels) lordosizing lumbar fusion for degenerative disc disease (DDD). METHODS: Twenty-six consecutive patients (13 males and 13 females) undergoing mono- or bisegmental lordosizing lumbar fusion (XLIF/TLIF) for lumbar DDD were included in the study. Clinical parameters were retrospectively collected from charts. Preoperative and early postoperative (6 weeks and 3 months) full-spine EOS X-rays were evaluated. Spinal parameters evaluating sagittal curvatures, pelvic orientation, global sagittal and coronal alignment, spino-pelvic balance, index level segmental lordosis and disc height were measured and statistically analyzed. RESULTS: A total of 16 TLIF and 10 XLIF procedures were performed. Eighteen were mono- and 8 were bisegmental fixations for a total of 34 fused segments. Seven patients (26.9%) showed a preoperative sagittal imbalance (defined as SVA>50 mm); 7 patients presented preoperative severe pelvic retroversion (defined as PT>20°) and 1 patient presented both. Disc height, intervertebral angle and segmental lordosis at the operated level significantly increased after surgery (P<0.01). No postoperative significant change in global sagittal alignment (SVA, TPA, T1SPi, T9SPi), pelvic orientation (SS, PT), coronal alignment, lumbar and L4-S1 lordosis and thoracic kyphosis have been observed. CONCLUSIONS: Mono- and bisegmental lordosizing fusion techniques, as XLIF and TLIF, are able to restore disc height and improve segmental lordosis. However they do not allow restoration of sagittal balance or improvement of compensatory mechanisms. A limited spinal reconstructive surgery on symptomatic levels can be reasonably proposed to patients with hidden or evident sagittal imbalance with any short-term radiographic impact.

Sexual and urinary function following anterior lumbar surgery in females.

AIMS: Anterior lumbar interbody fusion procedures (ALIF) and total disc replacement (TDR) with anterior exposure of the lumbar spine entail a risk of a vascular injury and dysfunction of the sympathetic and parasympathetic nerves due to disturbance of the inferior and superior hypogastric plexus. While retrograde ejaculation is a known complication of the anterior spinal approach in males, post-operative sexual as well as urinary function in females has not yet been thoroughly investigated and was hence the aim of this study. METHODS: Fifteen female patients documented their sexual and urinary function preoperatively, 3 months and 6 months postoperatively, using the validated questionnaires FSFI (Female Sexual Function Index) and ICIQ (International Consultation of Incontinence Questionnaire). Randomization tests were used to statistically analyze expectation values over time (two-sided, P < 0.05). RESULTS: While no statistically significant change in the total FSFI score occurred over time, a significant increase in FSFI desire score was noted between preoperative (2.95 ± 0.8) and 6 months follow-up (3.51 ± 0.6, P = 0.02). Urinary continence remained unchanged over time. CONCLUSION: In summary, ALIF and lumbar TDR do not seem to negatively influence sexual and urinary function in females. In contrast, increased sexual desire was noted, likely secondary to post-surgical pain relief.

Central nervous system microbleeds in the acute phase are associated with structural integrity by DTI one year after mild traumatic brain injury: A longitudinal study.

INTRODUCTION: Several imaging modalities are under investigation to unravel the pathophysiological mystery of delayed performance deficits in patients after mild traumatic brain injury (mTBI). Although both imaging and neuropsychological studies have been conducted, only few data on longitudinal correlations of diffusion tensor imaging (DTI), susceptibility weighted imaging (SWI) and extensive neuropsychological testing exist. METHODS: MRI with T1- and T2-weighted, SWI and DTI sequences at baseline and 12 months of 30 mTBI patients were compared with 20 healthy controls. Multiparametric assessment included neuropsychological testing of cognitive performance and post-concussion syndrome (PCS) at baseline, 3 and 12 months post-injury. Data analysis encompassed assessment of cerebral microbleeds (Mb) in SWI, tract-based spatial statistics (TBSS) and voxel-based morphometry (VBM) of DTI (VBM-DTI). Imaging markers were correlated with neuropsychological testing to evaluate sensitivity to cognitive performance and post-concussive symptoms. RESULTS: Patients with Mb in SWI in the acute phase showed worse performance in several cognitive tests at baseline and in the follow-ups during the chronic phase and higher symptom severity in the post concussion symptom scale (PCSS) at twelve months post-injury. In the acute phase there was no statistical difference in structural integrity as measured with DTI between mTBI patients and healthy controls. At twelve months post-injury, loss of structural integrity in mTBI patients was found in nearly all DTI indices compared to healthy controls. CONCLUSIONS: Presence of Mb detected by SWI was associated with worse cognitive outcome and persistent PCS in mTBI patients, while DTI did not prove to predict neuropsychological outcome in the acute phase.