Urine Albumin Measurements in Clinical Diagnostics.

BACKGROUND: Measurement of urine albumin is critical for diagnosis, risk classification, and monitoring of chronic kidney disease (CKD). Guidelines recommend clinical decision cutoffs for the urine albumin-to-creatinine ratio (ACR) of 30 and 300 mg/g (3 and 30 mg/mmol). However, differences among manufacturers' routine urine albumin measurement procedures have been found to exceed 40%, suggesting CKD diagnosis and risk classification may vary depending upon the specific measurement procedure implemented in the laboratory. CONTENT: This review discusses urine albumin pathophysiology and clinical practice guideline recommendations for CKD. The review also provides recommendations for urine specimen collection and storage, and results reporting for the ACR. Recent advances in measurement techniques and development of reference systems intended to facilitate standardization of urine albumin measurements are reviewed. SUMMARY: Urine albumin is an important measurement procedure used for diagnosis, risk classification, and management of CKD. Urine albumin results should be reported as the ACR using quantitative measurement procedures. Random urine collections used for albuminuria screening should be followed by confirmation with first morning void collections to reduce variation and increase diagnostic accuracy for urine albumin measurement. Most measurement procedures utilize immunoturbidimetric or immunonephelometric techniques. However, results vary significantly among measurement procedures, potentially resulting in differences in classification or risk assessment for CKD. The National Institute for Standards and Technology (NIST) and other laboratories are developing reference systems, including liquid chromatography-tandem mass spectrometry candidate reference measurement procedures and reference materials, to enable standardization of routine measurement procedures.

Extent of Equivalence of Results for Urine Albumin among 3 Candidate Mass Spectrometry Reference Measurement Procedures.

BACKGROUND: Urine albumin (UA) is an important biomarker of chronic kidney disease. Current in vitro diagnostic medical devices (IVD-MDs) for measuring UA are not standardized, and median results among IVD-MDs differ by approximately 45%. Since fixed decision values are used to interpret UA, higher-order reference measurement procedures (RMPs) are needed for metrological traceability. Three candidate liquid chromatography-tandem mass spectrometry RMPs have been developed for UA. METHODS: Eight single-donation human urine samples were measured by 3 candidate RMPs. Results were compared using t-test and variance component analysis. RESULTS: The mean results for each urine sample from each RMP laboratory were not statistically different from the overall mean value by t-test. The median total CV including contributions from bias and imprecision among the 3 RMP laboratories was 6.23% using variance component analysis for each sample. The allowable bias to the RMP for an end-user IVD-MD was ≦9.0% or ≦3.0% based on the desirable or optimal total allowable error of 30% or 24%, respectively. A maximum allowable standard uncertainty for an RMP result was determined to be 4.3% or 3.3% for desirable or optimal performance, respectively. The standard uncertainties for all of the RMP laboratories meet the desirable and optimal standard uncertainty specifications. CONCLUSION: The candidate RMPs for UA in these 3 laboratories have suitable agreement of results and uncertainties for use as higher-order RMPs in the metrological traceability of end-user IVD-MDs for measuring UA.

Validation of the AO Spine CROST (Clinician Reported Outcome Spine Trauma) in the clinical setting.

PURPOSE: To evaluate feasibility, internal consistency, inter-rater reliability, and prospective validity of AO Spine CROST (Clinician Reported Outcome Spine Trauma) in the clinical setting. METHODS: Patients were included from four trauma centers. Two surgeons with substantial amount of experience in spine trauma care were included from each center. Two separate questionnaires were administered at baseline, 6-months and 1-year: one to surgeons (mainly CROST) and another to patients (AO Spine PROST-Patient Reported Outcome Spine Trauma). Descriptive statistics were used to analyze patient characteristics and feasibility, Cronbach's α for internal consistency. Inter-rater reliability through exact agreement, Kappa statistics and Intraclass Correlation Coefficient (ICC). Prospective analysis, and relationships between CROST and PROST were explored through descriptive statistics and Spearman correlations. RESULTS: In total, 92 patients were included. CROST showed excellent feasibility results. Internal consistency (α = 0.58-0.70) and reliability (ICC = 0.52 and 0.55) were moderate. Mean total scores between surgeons only differed 0.2-0.9 with exact agreement 48.9-57.6%. Exact agreement per CROST item showed good results (73.9-98.9%). Kappa statistics revealed moderate agreement for most CROST items. In the prospective analysis a trend was only seen when no concerns at all were expressed by the surgeon (CROST = 0), and moderate to strong positive Spearman correlations were found between CROST at baseline and the scores at follow-up (rs = 0.41-0.64). Comparing the CROST with PROST showed no specific association, nor any Spearman correlations (rs = -0.33-0.07). CONCLUSIONS: The AO Spine CROST showed moderate validity in a true clinical setting including patients from the daily clinical practice.

Supplementary value and diagnostic performance of computed tomography scout view in the detection of thoracolumbar spine injuries.

PURPOSE: Assessing the diagnostic performance and supplementary value of whole-body computed tomography scout view (SV) images in the detection of thoracolumbar spine injuries in early resuscitation phase and identifying frequent image quality confounders. METHODS: In this retrospective database analysis at a tertiary emergency center, three blinded senior experts independently assessed SV to detect thoracolumbar spine injuries. The findings were categorized according to the AO Spine classification system. Confounders impacting SV image quality were identified. The suspected injury level and severity, along with the confidence level, were indicated. Diagnostic performance was estimated using the caret package in R programming language. RESULTS: We assessed images of 199 patients, encompassing 1592 vertebrae (T10-L5), and identified 56 spinal injuries (3.5%). Among the 199 cases, 39 (19.6%) exhibited at least one injury in the thoracolumbar spine, with 12 (6.0%) of them displaying multiple spinal injuries. The pooled sensitivity, specificity, and accuracy were 47%, 99%, and 97%, respectively. All experts correctly identified the most severe injury of AO type C. The most common image confounders were medical equipment (44.6%), hand position (37.6%), and bowel gas (37.5%). CONCLUSION: SV examination holds potential as a valuable supplementary tool for thoracolumbar spinal injury detection when CT reconstructions are not yet available. Our data show high specificity and accuracy but moderate sensitivity. While not sufficient for standalone screening, reviewing SV images expedites spinal screening in mass casualty incidents. Addressing modifiable factors like medical equipment or hand positioning can enhance SV image quality and assessment.

Patient and Provider Satisfaction with Asynchronous Versus Synchronous Telepsychiatry in Primary Care: A Secondary Mixed-Methods Analysis of a Randomized Controlled Trial.

Background: Asynchronous telepsychiatry (ATP) consultations are a novel form of psychiatric consultation. Studies comparing patient and provider satisfaction for ATP with that for synchronous telepsychiatry (STP) do not exist. Methods: This mixed-methods study is a secondary analysis of patients' and primary care providers' (PCPs) satisfaction from a randomized clinical trial of ATP compared with STP. Patients and their PCPs completed satisfaction surveys, and provided unstructured feedback about their experiences with either ATP or STP. Differences in patient satisfaction were assessed using mixed-effects logistic regression models, and the qualitative data were analyzed using thematic analysis with an inductive coding framework. Results: Patient satisfaction overall was high with 84% and 97% of respondents at 6 months reported being somewhat or completely satisfied with ATP and STP, respectively. Patients in the STP group were more likely to report being completely satisfied, to recommend the program to a friend, and to report being comfortable with their care compared with ATP (all p < 0.05). However, there was no difference between the patients in ATP and STP in perceived change in clinical outcomes (p = 0.51). The PCP quantitative data were small, and thus only summarized descriptively. Conclusions: Patients expressed their overall satisfaction with both STP and ATP. Patients in ATP reported more concerns about the process, likely because feedback after ATP was slower than that after STP consultations. PCPs had no apparent preference for STP or ATP, and reported implementing the psychiatrists' recommendations for both groups when such recommendations were made, which supports our previous findings. Trial Registration: ClinicalTrials.gov NCT02084979; https://clinicaltrials.gov/ct2/show/NCT02084979.

Anterior thoracolumbar column reconstruction with the vertebral body stent-safety and efficacy.

PURPOSE: The aim of this study was to assess safety and efficacy of vertebral body stenting (VBS) by analyzing (1) radiographic outcome, (2) clinical outcome, and (3) perioperative complications in patients with vertebral compression fractures treated with VBS at minimum 6-month follow-up. METHODS: In this retrospective cohort study, 78 patients (61 ± 14 [21-90] years; 67% female) who have received a vertebral body stent due to a traumatic, osteoporotic or metastatic thoracolumbar compression fracture at our hospital between 2012 and 2020 were included. Median follow-up was 0.9 years with a minimum follow-up of 6 months. Radiographic and clinical outcome was analyzed directly, 6 weeks, 12 weeks, 6 months postoperatively, and at last follow-up. RESULTS: Anterior vertebral body height of all patients improved significantly by mean 6.2 ± 4.8 mm directly postoperatively (p < 0.0001) and remained at 4.3 ± 5.1 mm at last follow-up compared to preoperatively (p < 0.0001). The fracture kyphosis angle of all patients improved significantly by mean 5.8 ± 6.9 degrees directly postoperatively (p < 0.0001) and remained at mean 4.9 ± 6.9 degrees at last follow-up compared to preoperatively (p < 0.0001). The segmental kyphosis angle of all patients improved significantly by mean 7.1 ± 7.6 degrees directly postoperatively (p < 0.0001) and remained at mean 2.8 ± 7.8 degrees at last follow-up compared to preoperatively (p = 0.03). Back pain was ameliorated from a preoperative median Numeric Rating Scale value of 6.5 to 3.0 directly postoperatively and further bettered to 1.0 six months postoperatively (p = 0.0001). Revision surgery was required in one patient after 0.4 years. CONCLUSION: Vertebral body stenting is a safe and effective treatment option for osteoporotic, traumatic and metastatic compression fractures.

An international validation of the AO spine subaxial injury classification system.

PURPOSE: To validate the AO Spine Subaxial Injury Classification System with participants of various experience levels, subspecialties, and geographic regions. METHODS: A live webinar was organized in 2020 for validation of the AO Spine Subaxial Injury Classification System. The validation consisted of 41 unique subaxial cervical spine injuries with associated computed tomography scans and key images. Intraobserver reproducibility and interobserver reliability of the AO Spine Subaxial Injury Classification System were calculated for injury morphology, injury subtype, and facet injury. The reliability and reproducibility of the classification system were categorized as slight (ƙ = 0-0.20), fair (ƙ = 0.21-0.40), moderate (ƙ = 0.41-0.60), substantial (ƙ = 0.61-0.80), or excellent (ƙ = > 0.80) as determined by the Landis and Koch classification. RESULTS: A total of 203 AO Spine members participated in the AO Spine Subaxial Injury Classification System validation. The percent of participants accurately classifying each injury was over 90% for fracture morphology and fracture subtype on both assessments. The interobserver reliability for fracture morphology was excellent (ƙ = 0.87), while fracture subtype (ƙ = 0.80) and facet injury were substantial (ƙ = 0.74). The intraobserver reproducibility for fracture morphology and subtype were excellent (ƙ = 0.85, 0.88, respectively), while reproducibility for facet injuries was substantial (ƙ = 0.76). CONCLUSION: The AO Spine Subaxial Injury Classification System demonstrated excellent interobserver reliability and intraobserver reproducibility for fracture morphology, substantial reliability and reproducibility for facet injuries, and excellent reproducibility with substantial reliability for injury subtype.

Health professionals' perspective on the applicability of AO Spine PROST (patient reported outcome Spine trauma) in people with a motor-complete traumatic or non-traumatic spinal cord injury.

PURPOSE: The AO Spine PROST (Patient Reported Outcome Spine Trauma) was developed for people with spine trauma and minor or no neurological impairment. The purpose is to investigate health professionals' perspective on the applicability of the AO Spine PROST for people with motor-complete traumatic or non-traumatic spinal cord injury (SCI), using a discussion meeting and international survey study. METHODS: A discussion meeting with SCI rehabilitation physicians in the Netherlands was performed, followed by a worldwide online survey among the AO Spine International community, involved in the care of people with SCI. Participants rated the comprehensibility, relevance, acceptability, feasibility and completeness of the AO Spine PROST on a 1-5 point scale (5 most positive). Comments could be provided per question. RESULTS: The discussion meeting was attended by 13 SCI rehabilitation physicians. The survey was completed by 196 participants. Comprehensibility (mean ± SD: 4.1 ± 0.8), acceptability (4.0 ± 0.8), relevance (3.9 ± 0.8), completeness (3.9 ± 0.8), and feasibility (4.1 ± 0.7) of the AO Spine PROST were rated positively for use in people with motor-complete traumatic or non-traumatic SCI. Only a few participants questioned the relevance of items on the lower extremities (e.g., walking) or missed items on pulmonary functioning and complications. Some recommendations were made for improvement in instructions, terminology and examples of the tool. CONCLUSION: Health professionals found the AO Spine PROST generally applicable for people with motor-complete traumatic or non-traumatic SCI. This study provides further evidence for the use of the AO Spine PROST in spine trauma care, rehabilitation and research, as well as suggestions for its further development.

MOSCATO: a supervised approach for analyzing multi-Omic single-Cell data.

BACKGROUND: Advancements in genomic sequencing continually improve personalized medicine, and recent breakthroughs generate multimodal data on a cellular level. We introduce MOSCATO, a technique for selecting features across multimodal single-cell datasets that relate to clinical outcomes. We summarize the single-cell data using tensors and perform regularized tensor regression to return clinically-associated variable sets for each 'omic' type. RESULTS: Robustness was assessed over simulations based on available single-cell simulation methods, and applicability was assessed through an example using CITE-seq data to detect genes associated with leukemia. We find that MOSCATO performs favorably in selecting network features while also shown to be applicable to real multimodal single-cell data. CONCLUSIONS: MOSCATO is a useful analytical technique for supervised feature selection in multimodal single-cell data. The flexibility of our approach enables future extensions on distributional assumptions and covariate adjustments.

Is New York State good at managing hollow viscus injury?

BACKGROUND: There are an estimated 100,000 cases of abdominal injury (ABI) in the USA, annually resulting in over $12 billion in direct medical cost and $18 billion in lost productivity. This study assesses the timeliness, safety, and efficacy of the surgical management of abdominal injuries (ABIs), hollow viscus injuries (HVIs), and colonic injuries (CIs) for patients residing in New York State (NYS). METHODS: Using data from NYS's Statewide Planning and Research Cooperative System (SPARCS), we identified all trauma patients with ABI admitted between 2006 and 2015. We subdivided ABI into HVI and CI using diagnosis and procedure codes and examined processes of care and outcomes adjusting for patient characteristics, injury severity score, structural, and process indicators. RESULTS: We identified 31,043 hospitalized patients with ABI, 71% were incurred from blunt forces. Most patients with ABI (72%) were treated at a Level I/II trauma center (TC) and 7% patients were transferred to Level I/II TC. Failure to be treated at Level I/II TC was associated with 16% increased hazard of death. HVI was diagnosed in 23% of ABI patients (n = 7294); 18% experienced delayed hollow viscus repair (dHVR); dHVR was associated with a 76% increased hazard of death. CI was diagnosed in 9% of ABI patients (n = 2921) and 18% experienced dHVR. Seventy-five percent of CI were repaired primarily (n = 1354). Less than 37% of stomas were reversed by 4 years of index trauma. CONCLUSION: Most abdominal trauma in NYS was caused by motor vehicle accidents, falls, and assault. dHVR and not being treated at Level I/II TC were associated with worse outcomes. More research is needed to reduce under-triage and delays in the operative treatment of blunt abdominal trauma.

Outcomes following robot-assisted versus laparoscopic sleeve gastrectomy: the New York State experience.

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) represents more than half of all bariatric procedures in the USA, and robot-assisted sleeve gastrectomy (RSG) is becoming increasingly common. There is a paucity of evidence regarding postoperative surgical outcomes (> 30 days) in RSG patients, especially as these patients move between multiple hospital systems. METHODS: Using 2012-2018 New York State's inpatient and ambulatory data from the Statewide Planning and Research Cooperative System, bivariate and multivariate analyses were employed to examine patient long-term outcomes, postoperative complications, and charges following RSG versus LSG in unmatched and propensity score-matched (PSM) samples. RESULTS: Among the 72,157 minimally invasive sleeve gastrectomies identified, 2365 (2.6%) were RSGs. In the PSM sample (2365 RSG matched to 23,650 LSG), RSG cases were more likely to be converted to an open procedure (2.3% vs 0.2% LSG patients, p < 0.01) and had a longer mean length of stay (LOS; 2.1 vs. 1.8 days LSG, p < 0.01). Postoperative complications were not different between RSG and LSG patients, but the proportion of emergency room visits resulting in inpatient readmissions was higher among RSG patients (5.5% vs. 4.2% in LSG patients, p < .01). Among the super obese (body mass index ≥ 50) patients, conversions to open procedure and LOS were also significantly higher for RSG versus LSG cases. Average hospital charges for the index admission ($47,623 RSG vs $35,934 LSG) and cumulative changes for 1 year from the date of surgery ($57,484 RSG vs $43,769 LSG) were > 30% higher for RSG patients. CONCLUSIONS: RSG patients were more likely to have conversions to open procedures, longer postoperative stay, readmissions, and higher charges for both the index admission and beyond, compared to LSG patients. No clear advantages emerged for the utilization of the robotic platform for either average risk or extremely obese patients.

Venous injection of a triphasic calcium-based implant in a sheep model of pulmonary embolism demonstrates minimal acute systemic effects.

PURPOSE: Implant leakage is the most common complication of vertebral augmentation. Alternative injectable materials must demonstrate intravascular safety comparable to or better than polymethyl methacrylate (PMMA). This study assessed the systemic effects of a triphasic calcium-based implant or PMMA injected directly into the femoral vein in a large animal model designed to mimic severe intravascular implant leakage. METHODS: Six skeletally mature female sheep were randomly assigned (n = 3) to either the PMMA or the triphasic implant (AGN1, composition: calcium sulfate, ß-tricalcium phosphate, brushite) treatment group. Femoral veins of each sheep were directly injected with 0.5 mL of implant material to mimic leakage volumes reported during PMMA vertebroplasty. To compare acute systemic effects of the materials, cardiovascular parameters, laboratory coagulation markers, and calcium and sulfate serum levels were monitored for 60 min after implant injection. Thrombotic and embolic events were evaluated by radiologic imaging, necropsy, and histopathology. RESULTS: Heart rate, systemic arterial blood pressure, arterial oxygenation, arterial carbon dioxide content, and coagulation markers remained within physiological range after either AGN1 or PMMA injection. No blood flow interruption in the larger pulmonary vessels was observed in either group. Lung histopathology revealed that the severity of thrombotic changes after AGN1 injection was minimal to slight, while changes after PMMA injection were minimal to massive. CONCLUSION: Acute systemic effects of intravascular AGN1 appeared to be comparable to or less than that of intravascular PMMA. Furthermore, in this preliminary study, the severity and incidence of pulmonary histological changes were lower for AGN1 compared to PMMA.

The Early (2009-2017) Experience With Robot-assisted Cholecystectomy in New York State.

OBJECTIVE: The aim of this study was to examine real-life patterns of care and patient outcomes associated with robot-assisted cholecystectomy (RAC) in New York State (NYS). BACKGROUND: Although robotic assistance may offer some technological advantages, RACs are associated with higher procedural costs and longer operating times compared to traditional laparoscopic cholecystectomies (LCs). Evidence on long-term patient outcomes after RAC from large population-based datasets remains limited and inconsistent. METHODS: Using NYS inpatient and ambulatory surgery data from the Statewide Planning and Research Cooperative System (2009-2017), we conducted bivariate and multivariate analyses to examine patterns of utilization, complications, and secondary procedures following cholecystectomies. RESULTS: Among 299,306 minimally invasive cholecystectomies performed in NYS between 2009 and 2017, one thousand one hundred eighteen (0.4%) were robot-assisted. Compared to those undergoing LC, RAC patients were older, travelled further for surgery, and were more likely to have public insurance and preoperative comorbidities. RAC versus LC patients were more significantly likely to have conversions to open procedure (4.9% vs 2.8%), bile duct injuries (1.3% vs 0.4%), and major reconstructive interventions (0.6% vs 0.1%), longer median length of stay (3 vs 1 day), readmissions (7.3% vs 4.4%), and higher 12-month post-index surgery hospital charges (P < 0.01 for all estimates). Other postoperative complications decreased over time for LC but remained unchanged for RAC patients. CONCLUSIONS: Patients receiving RAC in NYS experienced higher rates of complications compared to LC patients. Addressing patient-, surgeon-, and system-level factors associated with intra/postoperative complications and applying recently promulgated safe cholecystectomy strategies coupled with advanced imaging modalities like fluorescence cholangiography to RAC may improve patient outcomes.

Teaching surgery novices and trainees advanced laparoscopic suturing: a trial and tribulations.

INTRODUCTION: The benefits of minimally invasive surgery are numerous; however, considerable variability exists in its application and there is a lack of standardized training for important advanced skills. Our goal was to determine whether participation in an advanced laparoscopic curriculum (ALC) results in improved laparoscopic suturing skills. METHODS AND PROCEDURES: Study design was a prospective, randomized controlled trial. Surgery novices and trainees underwent baseline FLS training and were pre-tested on bench models. Participants were stratified by pre-test score and randomized to undergo either further FLS training (control group) or ALC training (intervention group). All were post-tested on the same bench model. Tests for differences between post-test scores of cohorts were performed using least squared means. Multivariable regression identified predictors of post-test score, and Wilcoxon rank sum test assessed for differences in confidence improvement in laparoscopic suturing ability between groups. RESULTS: Between November 2018 and May 2019, 25 participants completed the study (16 females; 9 males). After adjustment for relevant variables, participants randomized to the ALC group had significantly higher post-test scores than those undergoing FLS training alone (mean score 90.50 versus 82.99, p = 0.001). The only demographic or other variables found to predict post-test score include level of training (p = 0.049) and reported years of video gaming (p = 0.034). There was no difference in confidence improvement between groups. CONCLUSIONS: Training using the ALC as opposed to basic laparoscopic skills training only is associated with superior advanced laparoscopic suturing performance without affecting improvement in reported confidence levels. Performance on advanced laparoscopic suturing tasks may be predicted by lifetime cumulative video gaming history and year of training but does not appear to be associated with other factors previously studied in relation to basic laparoscopic skills, such as surgical career aspiration or musical ability.

3D analysis of fatty infiltration of the paravertebral lumbar muscles using T2 images-a new approach.

PURPOSE: Factors influencing paraspinal muscle degeneration are still not well understood. Fatty infiltration is known to be one main feature of the degeneration cascade. The aim of this cross-sectional study was to illustrate the 3D cluster of paraspinal lumbar muscle degeneration on T2-weighted MRI images using our newly developed software application 'iSix'. METHODS: Mono- (Mm. rotatores), multi- (Mm. multifidus) and pluri-segmental (M. erector spinae) lumbar muscles groups were segmented on T2-weighted MR sequences using a novel computer-assisted technique for quantitative muscle/fat discrimination. The degree of fatty infiltration of the three predefined muscle groups was compared on a 3-dimensional basis, with regard to segment involvement and age. General linear models were utilized for statistical comparison. RESULTS: N = 120 segments (age: 52.7; range 16-87 years) could be included. The overall relative fatty infiltration of the mono-segmental muscles was higher (21.1 14.5%) compared to the multi-segmental (16.0 8.8% p = 0.049) and pluri-segmental muscles (8.5 8.0%; p = 0.03). Mono-segmental muscles on the levels L4/5 (22.9 ± 10.2 [CI 17.6-28.2] %) and L5/S1 (27.01 ± 15.1 [CI 21.4-32.7] %) showed a significant higher amount of fat compared to the levels L2/3 (8.2 ± 6.8 [CI 2.2-14.2] %; L4/5 vs. L2/3, p = 0.03; L5/S1 vs. L2/3, p = 0.02) and L3/4 (13.2 ± 5.4 [CI 8.6-17.7]%; L4/5 vs. L3/4, p = 0.02; L5/S1 vs. L3/4, p < 0.01). Multivariate linear regression analyses revealed age and Pfirrmann grade as independent factors for fatty muscle degeneration. CONCLUSIONS: 3D analysis of fatty infiltration is an innovative tool to study lumbar muscle degeneration. Mono-segmental muscles are more severely affected by degeneration compared to multi-/pluri-segmental muscles, especially at the L4/5 and L5/S1 level. Age and disc degeneration independently correlate with muscle degeneration.

Reliability, validity and responsiveness of the Dutch version of the AOSpine PROST (Patient Reported Outcome Spine Trauma).

PURPOSE: To validate the Dutch version of AOSpine PROST (Patient Reported Outcome Spine Trauma). METHODS: Patients were recruited from two level-1 trauma centers from the Netherlands. Next to the AOSpine PROST, patients also filled out SF-36 for concurrent validity. Descriptive statistics were used to analyze the characteristics. Content validity was assessed by evaluating the number of inapplicable or missing questions. Also floor and ceiling effects were analyzed. Internal consistency was assessed by calculating Cronbach's α and item-total correlation coefficients (itcc). Spearman correlation tests were performed within AOSpine PROST items and in correlation with SF-36. Test-retest reliability was analyzed using Intraclass Correlation Coefficients (ICC). Responsiveness was assessed by calculating effect sizes (ES) and standardized response mean (SRM). Factor analysis was performed to explore any dimensions within AOSpine PROST. RESULTS: Out of 179 enrolled patients, 163 (91.1%) were included. Good results were obtained for content validity. No floor or ceiling effects were seen. Internal consistency was excellent (Cronbach's α = 0.96, itcc 0.50-0.86), with also good Spearman correlations (0.25-0.79). Compared to SF-36, the strongest correlation was seen for physical functioning (0.79; p < .001). Also test-retest reliability was excellent (ICC = 0.92). Concerning responsiveness analysis, very good results were seen with ES = 1.81 and SRM = 2.03 (p < 0.001). Factor analysis revealed two possible dimensions (Eigenvalues > 1), explaining 65.4% of variance. CONCLUSIONS: Very satisfactory results were obtained for reliability, validity and responsiveness of the Dutch version of AOSpine PROST. Treating surgeons are encouraged to use this novel and validated tool in clinical setting and research to contribute to evidence-based and patient-centered care.

Regional and experiential differences in surgeon preference for the treatment of cervical facet injuries: a case study survey with the AO Spine Cervical Classification Validation Group.

PURPOSE: The management of cervical facet dislocation injuries remains controversial. The main purpose of this investigation was to identify whether a surgeon's geographic location or years in practice influences their preferred management of traumatic cervical facet dislocation injuries. METHODS: A survey was sent to 272 AO Spine members across all geographic regions and with a variety of practice experience. The survey included clinical case scenarios of cervical facet dislocation injuries and asked responders to select preferences among various diagnostic and management options. RESULTS: A total of 189 complete responses were received. Over 50% of responding surgeons in each region elected to initiate management of cervical facet dislocation injuries with an MRI, with 6 case exceptions. Overall, there was considerable agreement between American and European responders regarding management of these injuries, with only 3 cases exhibiting a significant difference. Additionally, results also exhibited considerable management agreement between those with ≤ 10 and > 10 years of practice experience, with only 2 case exceptions noted. CONCLUSION: More than half of responders, regardless of geographical location or practice experience, identified MRI as a screening imaging modality when managing cervical facet dislocation injuries, regardless of the status of the spinal cord and prior to any additional intervention. Additionally, a majority of surgeons would elect an anterior approach for the surgical management of these injuries. The study found overall agreement in management preferences of cervical facet dislocation injuries around the globe.

Variation in global treatment for subaxial cervical spine isolated unilateral facet fractures.

PURPOSE: To determine the variation in the global treatment practices for subaxial unilateral cervical spine facet fractures based on surgeon experience, practice setting, and surgical subspecialty. METHODS: A survey was sent to 272 members of the AO Spine Subaxial Injury Classification System Validation Group worldwide. Questions surveyed surgeon preferences with regard to diagnostic work-up and treatment of fracture types F1-F3, according to the AO Spine Subaxial Cervical Spine Injury Classification System, with various associated neurologic injuries. RESULTS: A total of 161 responses were received. Academic surgeons use the facet portion of the AO Spine classification system less frequently (61.6%) compared to hospital-employed and private practice surgeons (81.1% and 81.8%, respectively) (p = 0.029). The overall consensus was in favor of operative treatment for any facet fracture with radicular symptoms (N2) and for any fractures categorized as F2N2 and above. For F3N0 fractures, significantly less surgeons from Africa/Asia/Middle East (49%) and Europe (59.2%) chose operative treatment than from North/Latin/South America (74.1%) (p = 0.025). For F3N1 fractures, significantly less surgeons from Africa/Asia/Middle East (52%) and Europe (63.3%) recommended operative treatment than from North/Latin/South America (84.5%) (p = 0.001). More than 95% of surgeons included CT in their work-up of facet fractures, regardless of the type. No statistically significant differences were seen in the need for MRI to decide treatment. CONCLUSION: Considerable agreement exists between surgeon preferences with regard to unilateral facet fracture management with few exceptions. F2N2 fracture subtypes and subtypes with radiculopathy (N2) appear to be the threshold for operative treatment.

"How to measure the outcome in the surgical treatment of vertebral compression fractures? A systematic literature review of highly cited level-I studies".

BACKGROUND: The economic burden of vertebral compression fractures (VCF) caused by osteoporosis was estimated at 37 billion euros in the European Union in 2010. In addition, the incidence is expected to increase by 25% in 2025. The recommendations for the therapy of VCFs (conservative treatment versus cement augmentation procedures) are controversial, what could be partly explained by the lack of standardized outcomes for measuring the success of both treatments. Consensus on outcome parameters may improve the relevance of a study and for further comparisons in meta-analyses. The aim of this study was to analyze outcome measures from frequently cited randomized controlled trials (RCTs) about VCF treatments in order to provide guidance for future studies. MATERIAL AND METHODS: We carried out a systematic search of all implemented databases from 1973 to 2019 using the Web of Science database. The terms "spine" and "random" were used for the search. We included: Level I RCTs, conservative treatment or cement augmentation of osteoporotic vertebral fractures, cited ≥50 times. The outcome parameters of each study were extracted and sorted according to the frequency of use. RESULTS: Nine studies met the inclusion criteria. In total, 23 different outcome parameters were used in the nine analyzed studies. Overall, the five most frequently used outcome parameters (≥ 4 times used) were the visual analogue scale (VAS) for pain (n = 9), European Quality of Life-5 Dimensions (EQ-5D; n = 4) and Roland-Morris Disability Questionnaire (RMDQ, n = 4). CONCLUSION: With our study, we demonstrated that a large inconsistency exists between outcome measures in highly cited Level I studies of VCF treatment. Pain (VAS), followed by HrQoL (EQ-5D) and disability and function (RMDQ), opioid use, and radiological outcome (kyphotic angle, VBH, and new VCFs) were the most commonly used outcome parameters.

Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial.

BACKGROUND: Asynchronous telepsychiatry (ATP; delayed-time) consultations are a novel form of psychiatric consultation in primary care settings. Longitudinal studies comparing clinical outcomes for ATP with synchronous telepsychiatry (STP) are lacking. OBJECTIVE: This study aims to determine the effectiveness of ATP in improving clinical outcomes in English- and Spanish-speaking primary care patients compared with STP, the telepsychiatry usual care method. METHODS: Overall, 36 primary care physicians from 3 primary care clinics referred a heterogeneous sample of 401 treatment-seeking adult patients with nonurgent psychiatric disorders. A total of 184 (94 ATP and 90 STP) English- and Spanish-speaking participants (36/184, 19.6% Hispanic) were enrolled and randomized, and 160 (80 ATP and 80 STP) of them completed baseline evaluations. Patients were treated by their primary care physicians using a collaborative care model in consultation with the University of California Davis Health telepsychiatrists, who consulted with patients every 6 months for up to 2 years using ATP or STP. Primary outcomes (the clinician-rated Clinical Global Impressions [CGI] scale and the Global Assessment of Functioning [GAF]) and secondary outcomes (patients' self-reported physical and mental health and depression) outcomes were assessed every 6 months. RESULTS: For clinician-rated primary outcomes, ATP did not promote greater improvement than STP at 6-month follow-up (ATP vs STP, adjusted difference in follow-up at 6 months vs baseline differences for CGI: 0.2, 95% CI -0.2 to 0.6; P=.28; and GAF: -0.6, 95% CI -3.1 to 1.9; P=.66) or 12-month follow-up (ATP vs STP, adjusted difference in follow-up at 12 months vs baseline differences for CGI: 0.4, 95% CI -0.04 to 0.8; P=.07; and GAF: -0.5, 95% CI -3.3 to 2.2; P=.70), but patients in both arms had statistically and clinically significant improvements in both outcomes. There were no significant differences in improvement from baseline between ATP and STP on any patient self-reported ratings at any follow-up (all P values were between .17 and .96). Dropout rates were higher than predicted but similar between the 2 arms. Of those with baseline visits, 46.8% (75/160) did not have a follow-up at 1 year, and 72.7% (107/147) did not have a follow-up at 2 years. No serious adverse events were associated with the intervention. CONCLUSIONS: This is the first longitudinal study to demonstrate that ATP can improve clinical outcomes in English- and Spanish-speaking primary care patients. Although we did not find evidence that ATP is superior to STP in improving clinical outcomes, it is potentially a key part of stepped mental health interventions available in primary care. ATP presents a possible solution to the workforce shortage of psychiatrists and a strategy for improving existing systems of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02084979; https://clinicaltrials.gov/ct2/show/NCT02084979.