Study Design.Heterogeneous data collection through a mix of prospective, retrospective, and ambispective methods. Objective.To evaluate the effect of biological sex on patient-reported outcomes after spinal fusion surgery for lumbar degenerative disease. Summary of Background Data.Current literature suggests sex differences regarding clinical outcome after spine surgery may exist. Substantial methodological heterogeneity and limited comparability of studies warrants further investigation of sex-related differences in treatment outcomes. Materials and Methods.We analyzed patients who underwent spinal fusion with or without pedicle screw insertion for lumbar degenerative disease included within a multinational study, comprising patients from 11 centers in seven countries. Absolute values and change scores (change from preoperative baseline to postoperative follow-up) for 12-month functional impairment [Oswestry disability index (ODI)] and back and leg pain severity [numeric rating scale (NRS)] were compared between male and female patients. Minimum clinically important difference (MCID) was defined as >30% improvement. Results.Six-hundred sixty (59%) of 1115 included patients were female. Female patients presented with significantly baseline ODI (51.5 +/- 17.2 vs. 47.8 +/- 17.9, P<0.001), back pain (6.96 +/- 2.32 vs. 6.60 +/- 2.30, P=0.010) and leg pain (6.49 +/- 2.76 vs. 6.01 +/- 2.76, P=0.005). At 12 months, female patients still reported significantly higher ODI (22.76 +/- 16.97 vs. 20.50 +/- 16.10, P=0.025), but not higher back (3.13 +/- 2.38 vs. 3.00 +/- 2.40, P=0.355) or leg pain (2.62 +/- 2.55 vs. 2.34 +/- 2.43, P=0.060). Change scores at 12 months did not differ significantly among male and female patients in ODI (triangle 1.31, 95% CI: -3.88 to 1.25, P=0.315), back (triangle 0.22, 95% CI: -0.57 to 0.12, P=0.197), and leg pain (triangle 0.16, 95% CI: -0.56 to 0.24, P=0.439). MCID at 12 months was achieved in 330 (77.5%) male patients and 481 (76.3%) female patients (P=0.729) for ODI. Conclusion.Both sexes experienced a similar benefit from surgery in terms of relative improvement in scores for functional impairment and pain. Although female patients reported a higher degree of functional impairment and pain preoperatively, at 12 months only their average scores for functional impairment remained higher than those for their male counterparts, while absolute pain scores were similar for female and male patients.

Study design: Heterogeneous data collection via a mix of prospective, retrospective, and ambispective methods. Objective: To evaluate the effect of biological sex on patient-reported outcomes after spinal fusion surgery for lumbar degenerative disease. Summary of Background Data: Current literature suggests sex differences regarding clinical outcome after spine surgery may exist. Substantial methodological heterogeneity and limited comparability of studies warrants further investigation of sex-related differences in treatment outcomes. Methods: We analyzed patients who underwent spinal fusion with or without pedicle screw insertion for lumbar degenerative disease included within a multinational study, comprising patients from 11 centers in 7 countries. Absolute values and change scores (change from pe-operative baseline to post-operative follow-up) for 12-month functional impairment (Oswestry disability index [ODI]) and back and leg pain severity (numeric rating scale [NRS]) were compared between male and female patients. Minimum clinically important difference (MCID) was defined as > 30% improvement. Results: Six-hundred-sixty (59%) of 1115 included patients were female. Female patients presented with significantly baseline ODI (51.5 ± 17.2 vs. 47.8 ± 17.9, P<0.001) and back pain (6.96 ± 2.32 vs. 6.60 ± 2.30, P=0.010) and leg pain (6.49 ± 2.76 vs. 6.01 ± 2.76, P=0.005). At 12-months, female patients still reported significantly higher ODI (22.76 ± 16.97 vs. 20.50 ± 16.10, P=0.025), but not higher back (3.13 ± 2.38 vs. 3.00 ± 2.40, P=0.355) or leg pain (2.62 ± 2.55 vs. .34 ± 2.43, P=0.060). Change scores at 12 months did not differ significantly among male and female patients in ODI (∆ 1.31, 95% CI -3.88-1.25, P=0.315), back (∆ 0.22, 95% CI -0.57-0.12, P=0.197) and leg pain (∆ 0.16, 95% CI -0.56-0.24, P=0.439). MCID at 12-months was achieved in 330 (77.5%) male patients and 481 (76.3%) female patients (P=0.729) for ODI. Conclusion: Both sexes experienced a similar benefit from surgery in terms of relative improvement in scores for functional impairment and pain. Although female patients reported a higher degree of functional impairment and pain preoperatively, at 12 months only their average scores for functional impairment remained higher than those for their male counterparts, while absolute pain scores were similar for female and male patients.

Abstract. Objectives:. The aim of this study was to determine the variations in effect for predictors of mortality over time and risk of in-hospital complications in geriatric patients with a hip fracture. Many studies have investigated risk factors of short-term and long-term mortality separately. In current literature, little is known about the variations in effect of risk factors over time and no comparison with the general population is made. Methods:. All patients with a hip fracture aged 70 years or older admitted to our hospital between January 1, 2016, and May 1, 2018, were included in this retrospective study. Patients who had undergone total hip arthroplasty (THA) were not included. The primary outcome was mortality after 1 year. Secondary outcomes were mortality after 30 days, 90 days, 2 years, and complications. Kaplan–Meier (KM) curves for risk factors were generated to visualize survival over time. Data were compared with data extracted from the national health records. Results:. A total of 685 geriatric patients with hip fractures were included with a 1-year mortality of 27%. The adjusted odds ratios (AOR) found differed over time. Five risk factors for mortality were investigated in this study using KM curves: age, prefracture living situation, dementia, sex, and ASA classification. Conclusions:. Over time, the variation of 5 risk factors for mortality were visualized in geriatric patients with a hip fracture: age, prefracture living situation, dementia, sex, and ASA classification. An elevated risk of mortality was discovered compared with the general population. The variation in effect observed in risk factors plays a vital role in prognosis. This insight will help guide accurate medical decision-making for a tailored treatment plan for geriatric patients with a hip fracture.

To evaluate healthcare utilization and satisfaction with treatment before and after implementing direct discharge (DD) from the Emergency Department (ED) of patients with simple, stable musculoskeletal injuries. Patients with simple, stable musculoskeletal injuries were included in two Dutch hospitals, both level-2 trauma centers: OLVG and Sint Antonius (SA), before (pre-DD-cohort) and after implementing DD (DD-cohort). With DD, no routine follow-up appointments are scheduled after the ED visit, supported by information leaflets, a smartphone application and a telephone helpline. Outcomes included: secondary healthcare utilization (follow-up appointments and X-ray/CT/MRI); satisfaction with treatment (scale 1–10); primary healthcare utilization (general practitioner (GP) or physiotherapist visited, yes/no). Linear regression was used to compare secondary healthcare utilization for all patients and per injury subgroup. Satisfaction and primary healthcare utilization were analyzed descriptively. A total of 2033 (OLVG = 1686; SA = 347) and 1616 (OLVG = 1396; SA = 220) patients were included in the pre-DD-cohort and DD-cohort, respectively. After DD, the mean number of follow-up appointments per patient reduced by 1.06 (1.13–0.99; p < 0.001) in OLVG and 1.07 (1.02–0.93; p < 0.001) in SA. Follow-up appointments reduced significantly for all injury subgroups. Mean number of follow-up X-rays per patient reduced by 0.17 in OLVG (p < 0.001) and 0.18 in SA (p < 0.001). Numbers of CT/MRI scans were low and comparable. In OLVG, mean satisfaction with treatment was 8.1 (pre-DD-cohort) versus 7.95 (DD-cohort), versus 7.75 in SA (DD-cohort only). In OLVG, 23.6% of pre-DD-cohort patients visited their GP, versus 26.1% in the DD-cohort, versus 13.3% in SA (DD-cohort only). Physiotherapist use was comparable. This study performed in a large population and additional hospital confirms earlier pilot results, i.e., that DD has the potential to effectively reduce healthcare utilization, while maintaining high levels of satisfaction. II.

The research questions for this study were as follows: (1) is the Parker Mobility Score (PMS) associated with discharge disposition and hospital length of stay (HLOS) of geriatric traumatic hip fracture patients? (2) Can the PMS be incorporated in a decision tree for the prediction of discharge disposition of geriatric traumatic hip fracture patients upon admittance. A dual-center retrospective cohort study was conducted at two level II trauma centers. All patients aged 70 years and older with traumatic hip fractures undergoing surgery in 2018 and 2019 were included consecutively (n = 649). A χ2 automatic interaction detection analysis was performed to determine the association of the PMS (and other variables) with discharge disposition and HLOS and predict discharge destination. The decision tree for discharge disposition classified patients with an overall accuracy of 82.1% and a positive predictive value of 91% for discharge to a rehabilitation facility. The PMS had the second most significant effect on discharge disposition (χ2 = 22.409, p < 0.001) after age (χ2 = 79.094, p < 0.001). Regarding the tree analysis of HLOS, of all variables in the analysis, PMS had the most significant association with HLOS (F = 14.891, p < 0.001). Patients who were discharged home had a mean HLOS of 6.5 days (SD 8.0), whereas patients who were discharged to an institutional care facility had a mean HLOS of 9.7 days (SD 6.4; p < 0.001). This study shows that the PMS was strongly associated with discharge disposition and HLOS. The decision tree for the discharge disposition of geriatric traumatic hip fracture patients offers a practical solution to start discharge planning upon admittance which could potentially reduce HLOS. Level III, diagnostic.

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/m(2), range 16.3-40.2 kg/m(2); 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.

Introduction Robotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the last decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared with conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high inherent costs. As a non-randomised, expertise-based study, the European Robotic Spinal Instrumentation Study aims to create prospective multicentre evidence on the potential comparative clinical benefits of RG, NV and FH in a real-world setting.Methods and analysis Patients are allocated in a non-randomised, non-blinded fashion to the RG, NV or FH arms. Adult patients that are to undergo thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumours or fractures are considered for inclusion. Deformity correction and surgery at more than five levels represent exclusion criteria. Follow-up takes place at 6 weeks, as well as 12 and 24 months. The primary endpoint is defined as the time to revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year. Secondary endpoints include patient-reported back and leg pain, as well as Oswestry Disability Index and EuroQOL 5-dimension questionnaires. Use of analgesic medication and work status are recorded. The primary analysis, conducted on the 12-month data, is carried out according to the intention-to-treat principle. The primary endpoint is analysed using crude and adjusted Cox proportional hazards models. Patient-reported outcomes are analysed using baseline-adjusted linear mixed models. The study is monitored according to a prespecified monitoring plan.Ethics and dissemination The study protocol is approved by the appropriate national and local authorities. Written informed consent is obtained from all participants. The final results will be published in an international peer-reviewed journal.Trial registration number Clinical Trials.gov registry NCT03398915; Pre-results, recruiting stage.

Patient-reported outcome measures following elective lumbar fusion surgery demonstrate major heterogeneity. Individualized prediction tools can provide valuable insights for shared decision-making. We externally validated the spine surgical care and outcomes assessment programme/comparative effectiveness translational network (SCOAP-CERTAIN) model for prediction of 12-month minimum clinically important difference in Oswestry Disability Index (ODI) and in numeric rating scales for back (NRS-BP) and leg pain (NRS-LP) after elective lumbar fusion. Data from a prospective registry were obtained. We calculated the area under the curve (AUC), calibration slope and intercept, and Hosmer–Lemeshow values to estimate discrimination and calibration of the models. We included 100 patients, with average age of 50.4 ± 11.4 years. For 12-month ODI, AUC was 0.71 while the calibration intercept and slope were 1.08 and 0.95, respectively. For NRS-BP, AUC was 0.72, with a calibration intercept of 1.02, and slope of 0.74. For NRS-LP, AUC was 0.83, with a calibration intercept of 1.08, and slope of 0.95. Sensitivity ranged from 0.64 to 1.00, while specificity ranged from 0.38 to 0.65. A lack of fit was found for all three models based on Hosmer–Lemeshow testing. The SCOAP-CERTAIN tool can accurately predict which patients will achieve favourable outcomes. However, the predicted probabilities—which are the most valuable in clinical practice—reported by the tool do not correspond well to the true probability of a favourable outcome. We suggest that any prediction tool should first be externally validated before it is applied in routine clinical practice. These slides can be retrieved under Electronic Supplementary Material.