Associations between single-question Visual Analogue Scale pain score and weight-bearing and non-weight-bearing domains of Western Ontario and McMaster Universities Arthritis Index pain: data from 2 phase 3 clinical trials.

Introduction: Visual Analogue Scale (VAS) and the pain subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) are commonly used measuring tools of osteoarthritis (OA) pain. Objectives: The objective of this cross-sectional study was to explore the associations between single-question VAS pain and the weight-bearing and non-weight-bearing domains of WOMAC pain. Methods: Data from 2093 patients with OA participating in 2 phase 3 clinical trials were included for post hoc analyses. Univariate Pearson correlations and comparison of r values were made using z statistics obtained using the Fisher r to z test for all items of the VAS pain scale, the WOMAC pain subscale, the weight-bearing and non-weight-bearing constructs of WOMAC pain subscale, and by subgroups of WOMAC pain quintiles and Kellgren-Lawrence grades. Results: The correlations between VAS pain and WOMAC pain were significant (r = 0.67, P < 0.001) with a slope of 0.57 (95% confidence interval [CI]: 0.54-0.61). A similar correlation was found for weight-bearing pain (r = 0.68, P < 0.001, slope: 0.62 (95% CI: 0.59-0.65) but significantly lower for non-weight-bearing pain (r = 0.55, P < 0.001, slope: 0.49 (95% CI: 0.46-0.52). The degree of disagreement between the 2 instruments seemed to be lesser in the extreme ends of the scales, and the observed association between Kellgren-Lawrence grade and disagreement between VAS and WOMAC was driven by non-weight-bearing pain. Conclusion: In conclusion, VAS pain and WOMAC pain subscale correlation was found to be moderate and the VAS pain scale correlated more accurately with the WOMAC pain weight-bearing questions. This constitutes novel insight into patient with OA pain reporting.

Perceptions in rib injuries: A multidisciplinary single center survey of clinician differences in risk stratification and management of patients with rib fractures.

BACKGROUND: Although associated with significant morbidity, there is no universally accepted management of rib fractures. We hypothesized that variations in risk stratification may influence this. METHODS: A questionnaire was developed to assess providers' perceived risk factors and injury stratification of rib fracture patients at a Level 1 trauma center. RESULTS: There were 143 responses (36% physician response rate). Hypoxia, age, number of ribs fractured, pre-existing pulmonary disease, and flail chest were identified as the most important risk factors determining morbidity and mortality in blunt chest trauma. While clinicians agreed on predicted mortality for <2 fractured ribs, significant variation for 5-6 and >8 rib fractures was seen. EM and surgery providers significantly differed in assessment of injury severity. CONCLUSION: Providers identified common risk factors for increased morbidity and mortality. However, the difference in perceived severity between providers indicates a need for clinical tools to assist in better standardizing rib fracture management.

Outcomes of preinjury anticoagulation in patients with traumatic rib fractures.

BACKGROUND: Anticoagulant and antiplatelet agents (ACAP) have been shown to negatively affect trauma patients. METHODS: Outcomes in adults with rib fractures were reviewed. Pearson chi-square test was used for analysis. Multivariate logistic regression was used to adjust for potential confounders. RESULTS: Of the 1448 included patients, 149 (10.3%) took preinjury ACAP; these patients were significantly older than non-anticoagulated patients (72 vs. 54 years, P ≤ 0.05). There was no difference in pulmonary complications, ICU admissions or ICU LOS. The preinjury ACAP group had a significantly longer LOS (12.03 vs. 9.33 days, P = 0.004), fewer pulmonary contusions (15.43% vs. 22.94%, P = 0.037), and fewer thoracic drainage procedures (10.74% vs. 18.17%, P = 0.023). Multivariate adjustment for possible confounders revealed that patients taking warfarin had a significantly longer LOS (+7.38 days). After adjustment there was no difference in mortality. CONCLUSION: Preinjury ACAP use does not increase mortality or morbidity in patients with rib fractures. SUMMARY: We demonstrated that preinjury anticoagulation and antiplatelet agents do not increase mortality or morbidity in patients with rib fractures. However, they lead to a longer hospital length of stay, particularly in patients on warfarin.

Endovascular aneurysm repair simulation can lead to decreased fluoroscopy time and accurately delineate the proximal seal zone.

BACKGROUND: The use of simulators for endovascular aneurysm repair (EVAR) is not widespread. We examined whether simulation could improve procedural variables, including operative time and optimizing proximal seal. For the latter, we compared suprarenal vs infrarenal fixation endografts, right femoral vs left femoral main body access, and increasing angulation of the proximal aortic neck. METHODS: Computed tomography angiography was obtained from 18 patients who underwent EVAR at a single institution. Patient cases were uploaded to the ANGIO Mentor endovascular simulator (Simbionix, Cleveland, Ohio) allowing for three-dimensional reconstruction and adapted for simulation with suprarenal fixation (Endurant II; Medtronic Inc, Minneapolis, Minn) and infrarenal fixation (C3; W. L. Gore & Associates Inc, Newark, Del) deployment systems. Three EVAR novices and three experienced surgeons performed 18 cases from each side with each device in randomized order (n = 72 simulations/participant). The cases were stratified into three groups according to the degree of infrarenal angulation: 0° to 20°, 21° to 40°, and 41° to 66°. Statistical analysis used paired t-test and one-way analysis of variance. RESULTS: Mean fluoroscopy time for participants decreased by 48.6% (P < .0001), and total procedure time decreased by 33.8% (P < .0001) when initial cases were compared with final cases. When stent deployment accuracy was evaluated across all cases, seal zone coverage in highly angulated aortic necks was significantly decreased. The infrarenal device resulted in mean aortic neck zone coverage of 91.9%, 89.4%, and 75.4% (P < .0001 by one-way analysis of variance), whereas the suprarenal device yielded 92.9%, 88.7%, and 71.5% (P < .0001) for the 0° to 20°, 21° to 40°, and 41° to 66° cases, respectively. Suprarenal fixation did not increase seal zone coverage. The side of femoral access for the main body did not influence proximal seal zone coverage regardless of infrarenal angulation. CONCLUSIONS: Simulation of EVAR leads to decreased fluoroscopy times for novice and experienced operators. Side of femoral access did not affect precision of proximal endograft landing. The angulated aortic neck leads to decreased proximal seal zone coverage regardless of infrarenal or suprarenal fixation devices.

Prevalence of Bovine Aortic Arch Configuration in Adult Patients with and without Thoracic Aortic Pathology.

BACKGROUND: Bovine aortic arch (BA) occurs in approximately 15-35% of the US population and is regarded as a clinically insignificant, normal variant. The aim of this study was to assess the prevalence of types I (type I bovine arch [T1BA], common origin of innominate and/or left common carotid artery) and II (type II bovine arch [T2BA], left common carotid originating from innominate) bovine arch in patients with and without thoracic aortic pathology. METHODS: We retrospectively reviewed all serial computed tomography images (n = 817) performed at our institution over 4 months to determine the overall prevalence of BA. Thoracic aorta and/or arch vessels were visualized, with images read by certified radiologists. A separate analysis compared a series of 156 consecutive patients with thoracic pathology (dissection or aneurysm ≥ 4.0 cm), from a 25-month period, with 757 control patients without pathology from the original sample. Statistical analysis included a chi-squared contingency table. RESULTS: Analysis revealed a bovine arch prevalence of 31.1% (n = 254), including 14.9% T1BA and 16.2% T2BA. Patients with thoracic aortopathy (n = 156) had aortic dissection (n = 26) or aneurysm (n = 130). These patients were older and had an increased prevalence of hypertension, hyperlipidemia, and aortic calcification. In addition, there was increased prevalence of T2BA in the pathology group (23.7%) compared with controls (15.9%; P = 0.03). T1BA was not significantly different between groups (11.5% vs. 14.9%; P = 0.59). When thoracic disease was stratified by pathology type, T2BA occurred more frequently in patients with thoracic aortic aneurysm (24.6% vs. 15.9%; P = 0.04). BA trended upward, in patients with thoracic aortic dissection (42.3% vs. 30.8%; P = 0.28). CONCLUSIONS: Our analyses revealed a prevalence of bovine arch of 31% in our patient population. BA occurred more frequently in patients with thoracic aortopathy than controls. Therefore, patients with BA may be associated with higher levels of thoracic aortic pathology and may benefit from increased clinical vigilance.

Comparative occupational radiation exposure between fixed and mobile imaging systems.

OBJECTIVE: Endovascular intervention exposes surgical staff to scattered radiation, which varies according to procedure and imaging equipment. The purpose of this study was to determine differences in occupational exposure between procedures performed with fixed imaging (FI) in an endovascular suite compared with conventional mobile imaging (MI) in a standard operating room. METHODS: A series of 116 endovascular cases were performed over a 4-month interval in a dedicated endovascular suite with FI and conventional operating room with MI. All cases were performed at a single institution and radiation dose was recorded using real-time dosimetry badges from Unfors RaySafe (Hopkinton, Mass). A dosimeter was mounted in each room to establish a radiation baseline. Staff dose was recorded using individual badges worn on the torso lead. Total mean air kerma (Kar; mGy, patient dose) and mean case dose (mSv, scattered radiation) were compared between rooms and across all staff positions for cases of varying complexity. Statistical analyses for all continuous variables were performed using t test and analysis of variance where appropriate. RESULTS: A total of 43 cases with MI and 73 cases with FI were performed by four vascular surgeons. Total mean Kar, and case dose were significantly higher with FI compared with MI. (mean ± standard error of the mean, 523 ± 49 mGy vs 98 ± 19 mGy; P < .00001; 0.77 ± 0.03 mSv vs 0.16 ± 0.08 mSv, P < .00001). Exposure for the primary surgeon and assistant was significantly higher with FI compared with MI. Mean exposure for all cases using either imaging modality, was significantly higher for the primary surgeon and assistant than for support staff (ie, nurse, radiology technologist) beyond 6 feet from the X-ray source, indicated according to one-way analysis of variance (MI: P < .00001; FI: P < .00001). Support staff exposure was negligible and did not differ between FI and MI. Room dose stratified according to case complexity (Kar) showed statistically significantly higher scattered radiation in FI vs MI across all quartiles. CONCLUSIONS: The scattered radiation is several-fold higher with FI than MI across all levels of case complexity. Radiation exposure decreases with distance from the radiation source, and is negligible outside of a 6-foot radius. Modern endovascular suites allow high-fidelity imaging, yet additional strategies to minimize exposure and occupational risk are needed.

Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes in a phase II clinical trial.

PURPOSE: In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process. Integrated electronic systems offer an opportunity to collect data in real time. PATIENTS AND METHODS: We created a computer software system to collect 13 patient-reported symptomatic adverse events and patient-reported Karnofsky performance status, semi-automated RECIST measurements, and laboratory data, and we made this information available to investigators in real time at the point of care during a phase II lung cancer trial. We assessed data completeness within 48 hours of each visit. Clinician satisfaction was measured. RESULTS: Forty-four patients were enrolled, for 721 total visits. At each visit, patient-reported outcomes (PROs) reflecting toxicity and disease-related symptoms were completed using a dedicated wireless laptop. All PROs were distributed in batch throughout the system within 24 hours of the visit, and abnormal laboratory data were available for review within a median of 6 hours from the time of sample collection. Manual attribution of laboratory toxicities took a median of 1 day from the time they were accessible online. Semi-automated RECIST measurements were available to clinicians online within a median of 2 days from the time of imaging. All clinicians and 88% of data managers felt there was greater accuracy using this system. CONCLUSION: Existing data management systems can be harnessed to enable real-time collection and review of clinical information during trials. This approach facilitates reporting of information closer to the time of events, and improves efficiency, and the ability to make earlier clinical decisions.