Urinalysis is predictive for absence of urinary tract infection in men with and without catheters.

OBJECTIVES: To determine accuracy of negative urinalysis (UA) for predicting negative urine culture and the absence of urinary tract infection (UTI), and optimal urine culture growth cutoff for UTI diagnosis in men with and without urinary catheters. SUBJECTS AND METHODS: UAs with urine cultures within 1 week from adult men were identified and evaluated. Predictive values for the absence of UTI (absence of ≥1 of the following criteria: documentation of UTI diagnosis, antibiotic prescription, uropathogen presence on culture) were calculated. RESULTS: In total, 22 883 UAs were included. Negative UA had a high predictive value for negative urine culture (0.95, 95% confidence interval [CI]: 0.94-0.95) and absence of UTI (0.99, CI: 0.99-0.995) in the overall cohort. Negative UA also had a high predictive value for negative urine culture (0.93, CI: 0.90-0.95) and absence of UTI (0.99, CI: 0.98-0.999) in those with indwelling urinary catheters. The traditional threshold of culture growth of 100 000 colony-forming units (CFU)/mL did not capture 22% of UTIs. CONCLUSION: UA exhibits high predictive value for negative urine culture and absence of UTI in men, supporting a protocol wherein culture is only performed in the context of abnormal UA. The traditional 100 000 CFU/mL cut-off may have not captured a subset of UTI in the male population, and warrants further investigation.

Surgical Management and Oncologic Outcomes of Renal Cell Carcinoma and Inferior Vena Caval Thrombi With Aggressive Histologic Variants.

OBJECTIVE: To characterize the surgical management, perioperative, and cancer-specific outcomes, and the influence of aggressive histologic variants (AHV) on operative management among patients with renal cell carcinoma (RCC) and inferior vena cava (IVC) thrombus. RCC with rhabdoid and/or sarcomatoid differentiation, which we defined as AHV, portends a worse prognosis. AHV can be associated with a desmoplastic reaction which may complicate resection. METHODS: We reviewed patients undergoing radical nephrectomy and IVC thrombectomy between 1990 and 2020. Comparative statistics were employed as appropriate. Survival analysis was performed according to the Kaplan-Meier method, and intergroup analysis performed with log-rank statistics. Multivariable cox proportional hazards regression was used to assess the effect of AHV, age, thrombus level, vena cavectomy, metastases, and medical comorbidities on recurrence and overall survival (OS). RESULTS: Ninety-four of 403 (23.3%) patients had AHV, including 43 (46%) rhabdoid, 39 (41%) sarcomatoid, and 12 (13%) with both. AHV were more likely to present with advanced disease; however, increased perioperative complications or decreased OS were not observed. Median (IQR) survival was 16.7 (4.8-47) months without AHV and 12.6 (4-29) months with AHV (P = .157). Sarcomatoid differentiation was independently associated with worse OS (HR = 2.016, CI 1.38-2.95, P <.001), whereas rhabdoid alone or with sarcomatoid demonstrated similar OS (P = 0.063). CONCLUSION: RCC and IVC thrombus with AHV are more likely to present with metastatic disease, and sarcomatoid differentiation is associated with a worse OS. Resection of tumors with and without AHV have similar perioperative complications, suggesting that surgery can be safely accomplished in patients with RCC and IVC thrombus with AHV.

First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor.

PURPOSE: Urodynamics is the standard method of diagnosing bladder dysfunction, but involves catheters and retrograde bladder filling. With these artificial conditions, urodynamics cannot always reproduce patient complaints. We have developed a wireless, catheter-free intravesical pressure sensor, the UroMonitor, which enables catheter-free telemetric ambulatory bladder monitoring. The purpose of this study was twofold: to evaluate accuracy of UroMonitor pressure data, and assess safety and feasibility of use in humans. MATERIALS AND METHODS: Eleven adult female patients undergoing urodynamics for overactive bladder symptoms were enrolled. After baseline urodynamics, the UroMonitor was transurethrally inserted into the bladder and position was confirmed cystoscopically. A second urodynamics was then performed with the UroMonitor simultaneously transmitting bladder pressure. Following removal of urodynamics catheters, the UroMonitor transmitted bladder pressure during ambulation and voiding in private. Visual analogue pain scales (0-5) were used to assess patient discomfort. RESULTS: The UroMonitor did not significantly alter capacity, sensation, or flow during urodynamics. The UroMonitor was also easily inserted and removed in all subjects. The UroMonitor reproduced bladder pressure, capturing 98% (85/87) of voiding and nonvoiding urodynamic events. All subjects voided with only the UroMonitor in place with low post-void residual volume. Median ambulatory pain score with the UroMonitor was rated 0 (0-2). There were no post-procedural infections or changes to voiding behavior. CONCLUSIONS: The UroMonitor is the first device to enable catheter-free telemetric ambulatory bladder pressure monitoring in humans. The UroMonitor appears safe and well tolerated, does not impede lower urinary tract function, and can reliably identify bladder events compared to urodynamics.

Outcomes of Inflatable Penile Prosthesis following Radical Cystectomy: A Matched Cohort Analysis.

OBJECTIVE: To evaluate outcomes of inflatable-penile-prosthesis (IPP) implantation after radical-cystectomy compared to other etiologies of erectile dysfunction. MATERIALS AND METHODS: All IPPs within the past 20 years in a large regional health system were reviewed, and erectile dysfunction (ED) etiology was determined as radical-cystectomy, radical-prostatectomy, or organic/other ED. Cohorts were generated by 1:3 propensity score match using age, body mass index, and diabetes status. Baseline demographics and relevant comorbidities were evaluated. Clavien-Dindo complications, grade, and reoperation were assessed. Multivariable logarithmic regression was used to identify the predictors of 90-day complications following IPP implantation. Log-rank analysis was used to assess the time-to-reoperation after IPP implantation in patients with a history of cystectomy compared with noncystectomy etiologies. RESULTS: Of 2600 patients, 231 subjects were included in the study. Comparing patients undergoing IPP for cystectomy vs pooled noncystectomy indications, those who underwent radical-cystectomy had a higher overall complication rate (24% vs 9%, p = 0.02). Clavien-Dindo complication grades did not differ across groups. Reoperation was significantly more common following cystectomy (cystectomy: 21% vs noncystectomy: 7%, p = 0.01), however time to reoperation did not differ significantly by indication (cystectomy: 8 years vs noncystectomy: 10 years,p = 0.09). Among cystectomy patients, 85% of reoperations were due to mechanical failure. CONCLUSION: Compared to other erectile dysfunction etiologies, patients undergoing IPP with a history of cystectomy have an increased risk of complications within 90-days of implantation and need for surgical device revision, but no greater risk for high-grade complications. Overall IPP remains a valid treatment option after cystectomy.

The elementary forms of digital communication.

Although a tremendous amount of modern interaction is electronic, our understanding of everyday digital communications-including what they look like and how their properties vary by medium and relationship type-is still growing. In this paper, we examine digital exchange in two of its simplest forms: email and SMS. Specifically, our data consist of 2,004 messages provided by a diverse sample of college students, supplemented by in-depth interviews with their authors. These data were collected in 2010-a time when both mediums were widespread but devoid of most of their modern complexity. Based on these data, we make two contributions: First, we develop an empirically grounded typology of the basic properties of text-based digital communication; second, we document the distribution of these properties across five common relationship types. Respectively, these findings provide a starting point to understanding the substance of digital exchange in all its many forms and an empirical benchmark for comparison.

Extensive dystrophic calcification of eroded artificial urinary sphincter cuff-a rare cause of urethral obstruction: a case report.

Background: Despite a high technical success rate and satisfaction, complications of an artificial urinary sphincter (AUS) can occasionally occur and vary in severity from transient urinary retention to unrecognized urethral injury or urethral erosion. Infection usually occurs when urine comes into contact with the device and necessitates explant of the cuff followed by delayed device replacement. In rare cases, however, the device can remain in contact with urine for long periods of time without the sequelae normally associated with acute infection. Case Description: Here we present a case report of two patients with intraurethral migration of AUS cuffs associated with calcification resulting in urethral obstruction precluding catheterization. With extensive calcification around the cuff and longstanding complete erosion into the urethra, the urologist can expect obliteration of normal tissue planes and intense fibrosis during cuff explantation. Following excision of the cuff and stones, assessment of the urethral lumen should be performed to determine whether repair of the urethra is required. After surgery, urinary diversion with a urethral catheter is important to allow for urethral healing. Prior to considering AUS replacement, cystoscopic assessment of the urethra is critical to assess for stricture or other abnormality. Conclusions: Extensive calcification following AUS erosion into the urethra requires the expertise of a urologist with experience in urethral surgery in order to optimize outcomes. Urologists should be aware of this uncommon, but dramatic presentation of urethral obstruction due to a chronically eroded AUS cuff.

Structural and Functional Characterization of Dynamic Oligomerization in Burkholderia cenocepacia HMG-CoA Reductase.

The enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase (HMGR), in most organisms, catalyzes the four-electron reduction of the thioester (S)-HMG-CoA to the primary alcohol (R)-mevalonate, utilizing NADPH as the hydride donor. In some organisms, including the opportunistic lung pathogen Burkholderia cenocepacia, it catalyzes the reverse reaction, utilizing NAD+ as a hydride acceptor in the oxidation of mevalonate. B. cenocepacia HMGR has been previously shown to exist as an ensemble of multiple non-additive oligomeric states, each with different levels of enzymatic activity, suggesting that the enzyme exhibits characteristics of the morpheein model of allostery. We have characterized a number of factors, including pH, substrate concentration, and enzyme concentration, that modulate the structural transitions that influence the interconversion among the multiple oligomers. We have also determined the crystal structure of B. cenocepacia HMGR in the hexameric state bound to coenzyme A and ADP. This hexameric assembly provides important clues about how the transition among oligomers might occur, and why B. cenocepacia HMGR, unique among characterized HMGRs, exhibits morpheein-like behavior.

Risk factors for hypogonadism in young men with erectile dysfunction.

BACKGROUND: The objective of this study is to evaluate the hormone profile of young men with the chief complaint of erectile dysfunction (ED) and determine the comorbidities in this population. METHODS: A retrospective chart review of men aged 18 to 40 years who presented with ED and had a hormone evaluation but without prior medication for hormone manipulation from 2002 to 2016 was performed at a tertiary care institution. Data were obtained on demographics, comorbidities, medications, and hormonal evaluations. RESULTS: A total of 2292 men with ED were identified and 2130 of them received testosterone level evaluation. The most common comorbidities that men were actively being treated for were depression (22.3%), anxiety (16.1%), hypertension (15.6%), diabetes (7.2%), cancer (6.2%), and cardiovascular disease (3.3%). The average total testosterone level was 368 ± 160 ng/dL; 10.7% of men had hypogonadism. Multivariate analysis demonstrated age, body mass index (BMI), depression, and cancer predicted a hypogonadal status. Patients with BMI > 28.2 kg/m, age > 34 years, cancer diagnosis, or depression were 3.350-fold, 1.447-fold, 2.317-fold, or 1.420-fold more likely to be diagnosed hypogonadal than nonoverweight, age ≤ 34 years, noncancer, or nondepressive patients. CONCLUSION: The majority of men under the age of 40 with ED exhibit a normal hormonal milieu. Young ED men with BMI > 28.2 kg/m, age >34 years, cancer diagnosis, or depression are at risk for hypogonadism.

The Timing and Frequency of Infectious Complications after Radical Cystectomy: An Opportunity for Rescue Antibiotic Treatment.

INTRODUCTION: We evaluated the timing, frequency and antibiotic sensitivity of post-radical cystectomy urinary tract infections to guide an infection reduction initiative. METHODS: A combined review was performed of all patients undergoing radical cystectomy in the 2011 to 2013 American College of Surgeons NSQIP® database and 100 consecutive patients from our institution. We evaluated the rates and timing of postoperative urinary tract infection and sepsis as well as associations with hospital readmissions. Specific culture data and treatment interventions were assessed and an institution specific urinary tract infection antibiogram was created. RESULTS: Among the 3,495 patients identified in the NSQIP database the 30-day rates of urinary tract infection and sepsis were 9.5% and 9.4%, respectively, and median days to urinary tract infection and sepsis were 15 and 13. Median length of stay after radical cystectomy was 10.4 days. Overall 61.5% of urinary tract infections and 52.1% of sepsis episodes occurred after discharge home. At our institution the rates of urinary tract infection and sepsis were 15% and 9%, and occurred at a median of 14 and 18 days, respectively. The 30-day readmission rate was 21%, with 10 readmissions for infections including 7 for urinary tract infection and 5 for bacteremia. We identified 9 patients with positive urine or blood cultures for yeast requiring antifungal therapy. Of the urinary tract infections 88% were sensitive to oral agents and 79% were sensitive to nitrofurantoin or ciprofloxacin. CONCLUSIONS: The timing of urinary tract infections/sepsis after radical cystectomy is predictable on the national and institutional level. At our hospital, cultured organisms are likely to respond to well tolerated oral therapies. This information can be used to implement an outpatient antibiotic protocol to prevent infectious complications after radical cystectomy.

Hemostatic Comparison of a Polysaccharide Powder and a Gelatin Powder.

Purpose/Aim: Powdered hemostats have been widely adopted for their ease-of-use; however, their efficacy has been limited resulting in applications restricted to low-level bleeds. This study investigates the use of bovine-derived gelatin particles (BGP) as a standalone hemostatic powder and compare BGP to commercially available microporous polysaccharide hemospheres (MPH). Materials and Methods: The powders were investigated for their hemostatic efficacy in a heparinized pre-clinical bleeding model limited to grade 1 and 2 bleeds on a validated intraoperative bleeding scale, which represents the accepted, clinical use of hemostatic powders. Results: At 10 minutes, the hemostatic success of lesions treated with BGP were 78% while MPH were 22%. The odds ratio for hemostatic success of BGP relative to MPH was 15.18 (95% CI: 7.37, 31.27). The 95% lower limit of the odds ratio was greater than 1. This indicates that BGP are superior to MPH (p < 0.001). The median time to hemostasis for BGP was 1.6 minutes and MPH was 14.5 minutes. The ratio for time to hemostasis of MPH relative to BGP was 9.23 (95% CI: 6.99, 12.19). This indicates that BGP achieve significantly faster time to hemostasis (p < 0.001). Conclusions: Characterization of tissue explant ultrastructure, particle size, and swelling revealed differences in the materials. BGP, in addition to absorbing fluid and concentrating clotting factors and platelets, integrate into the clot and stabilize the fibrin matrix. BGP have advantages over MPH in terms of speed and efficacy. BGP are a favorable biomaterial for further research that greatly improve the limited efficacy of powdered hemostats.

Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties.

INTRODUCTION: Intraoperative surgical sealants and hemostatic agents have been shown to reduce postoperative complications, transfusions, and hospital resource utilization. Despite availability of these agents, the incidence and burden of bleeding remains high and surgeons' requirements for hemostatic control continue to evolve. A burgeoning class of hemostatic agents are hemostatic patches, which offer package-to-patient readiness and direct application. In addition, hemostatic patches may provide tissue sealing capabilities. Areas covered: This review focuses on the clinical effectiveness, versatility, and surgical efficiency of HEMOPATCH as a surgical sealant and hemostatic agent in various surgical specialties including: cardiac, digestive (hepatic, gastrointestinal, pancreatic), urological, neurological, and endocrine. Expert commentary: Among hemostatic patches, HEMOPATCH is a valuable tool to stop bleeding without adverse events across various surgical specialties. Clinical evidence demonstrates the safety, clinical effectiveness, and versatility of HEMOPATCH as a unique surgical adjunct in patients undergoing complex and routine surgical procedures. Larger randomized-controlled clinical studies, or clinical registries, will continue to be used to evaluate its performance and versatility, particularly for sealing tissues and closing the dura. In the current field of surgical sealing and hemostasis, however, HEMOPATCH represents the next step in improving patient outcomes.

Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND: The authors' study represents the first level I evidence to assess whether intraoperative nerve blocks improve the quality of recovery from immediate tissue expander/implant breast reconstruction. METHODS: A prospective, randomized, double-blinded, placebo-controlled clinical trial was conducted in which patients undergoing immediate tissue expander/implant breast reconstruction were randomized to either (1) intraoperative intercostal and pectoral nerve blocks with 0.25% bupivacaine with 1:200,000 epinephrine and 4 mg of dexamethasone or (2) sham nerve blocks with normal saline. The 40-item Quality of Recovery score, pain score, and opioid use in the postoperative period were compared statistically between groups. Power analysis ensured 80 percent power to detect a 10-point (clinically significant) difference in the 40-item Quality of Recovery score. RESULTS: Forty-seven patients were enrolled. Age, body mass index, laterality, mastectomy type, and lymph node dissection were similar between groups. There were no statistical differences in quality of recovery, pain burden as measured by visual analogue scale, opioid consumption, antiemetic use, or length of hospital stay between groups at 24 hours after surgery. Mean global 40-item Quality of Recovery scores were 169 (range, 155 to 182) for the treatment arm and 165 (range, 143 to 179) for the placebo arm (p = 0.36), indicating a high quality of recovery in both groups. CONCLUSION: Although intraoperative nerve blocks can be a safe adjunct to a comprehensive postsurgical recovery regimen, the authors' results indicate no effect on overall quality of recovery from tissue expander/implant breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Safety and Efficacy of a Novel, Self-Adhering Dural Substitute in a Canine Supratentorial Durotomy Model.

BACKGROUND: Cerebrospinal fluid (CSF) leaks increase postoperative risk for complication, likelihood of reoperation, and costs. OBJECTIVE: To investigate a novel, self-adhering polyethylene glycol-coated collagen pad (PCC) as a dural substitute relative to Duragen XS (DGX; Integra LifeSciences Corporation, Plainsboro, New Jersey) and as a dural sealant relative to Tachosil (Takeda Austria GmbH, Linz, Austria), a fibrinogen and thrombin-coated collagen pad (FTC). METHODS: A canine supratentorial durotomy surgical model was used to investigate the safety and efficacy of PCC. For safety, 4 animals were bilaterally treated with DGX or PCC and recovered for 1, 8, or 16 wk; total 24 animals. Each animal underwent physical and neurological examinations weekly and 16-wk animals underwent a magnetic resonance imaging (MRI) examination at each time point. For efficacy, 9 animals were unilaterally treated with FTC or PCC and underwent a burst pressure test intraoperatively or 14 d postoperatively; total 36 animals. RESULTS: In the safety study, no abnormal clinical signs or changes were noted on physical and neurological examinations, or in clinical pathology, CSF analysis or histopathology of DGX or PCC-treated animals. No consistent signs of cerebral compression, CSF leak, hemorrhage, or hydrocephalus were noted on MRI. In the efficacy study, no significant difference was found between FTC and PCC at each time point or overall (13.9 vs 12.3 mm Hg, n = 18 per group, P = .46). CONCLUSION: PCC is safe for use as a dural substitute and effective as a dural sealant. The novel, self-adhering combination of a polyethylene glycol-based sealant and a collagen pad may offer unique benefits to the advancement of duraplasty.

Adrenergic and glucocorticoid receptor antagonists reduce ozone-induced lung injury and inflammation.

Recent studies showed that the circulating stress hormones, epinephrine and corticosterone/cortisol, are involved in mediating ozone-induced pulmonary effects through the activation of the sympathetic-adrenal-medullary (SAM) and hypothalamus-pituitary-adrenal (HPA) axes. Hence, we examined the role of adrenergic and glucocorticoid receptor inhibition in ozone-induced pulmonary injury and inflammation. Male 12-week old Wistar-Kyoto rats were pretreated daily for 7days with propranolol (PROP; a non-selective ß adrenergic receptor [AR] antagonist, 10mg/kg, i.p.), mifepristone (MIFE; a glucocorticoid receptor [GR] antagonist, 30mg/kg, s.c.), both drugs (PROP+MIFE), or respective vehicles, and then exposed to air or ozone (0.8ppm), 4h/d for 1 or 2 consecutive days while continuing drug treatment. Ozone exposure alone led to increased peak expiratory flow rates and enhanced pause (Penh); with greater increases by day 2. Receptors blockade minimally affected ventilation in either air- or ozone-exposed rats. Ozone exposure alone was also associated with marked increases in pulmonary vascular leakage, macrophage activation, neutrophilic inflammation and lymphopenia. Notably, PROP, MIFE and PROP+MIFE pretreatments significantly reduced ozone-induced pulmonary vascular leakage; whereas PROP or PROP+MIFE reduced neutrophilic inflammation. PROP also reduced ozone-induced increases in bronchoalveolar lavage fluid (BALF) IL-6 and TNF-α proteins and/or lung Il6 and Tnfα mRNA. MIFE and PROP+MIFE pretreatments reduced ozone-induced increases in BALF N-acetyl glucosaminidase activity, and lymphopenia. We conclude that stress hormones released after ozone exposure modulate pulmonary injury and inflammatory effects through AR and GR in a receptor-specific manner. Individuals with pulmonary diseases receiving AR and GR-related therapy might experience changed sensitivity to air pollution.

Cost-effectiveness analysis of a sealing hemostat patch (HEMOPATCH) vs standard of care in cardiac surgery.

BACKGROUND: A recent randomized controlled trial showed that patients undergoing ascending aorta surgery treated with HEMOPATCH to control bleeding had a significantly better hemostasis success rate than with dry or wet gauze compression or similar standard of care (SOC). OBJECTIVE: To compare the cost-effectiveness using two different agents for hemostasis (HEMOPATCH vs dry or wet gauze compression or similar SOC) in cardiac surgery from the European hospital perspective. METHODS: A literature-based cost-effectiveness model estimating average cost per successful hemostasis event was developed based on the hemostasis efficacy difference (HEMOPATCH = 97.6%, SOC = 65.8%, p < .001). Additional clinically significant end-points studied in the trial (blood transfusions and surgical revisions) were also analyzed. It was assumed that each surgery utilized two units of HEMOPATCH (dimensions of 4.5 × 9 cm) and two units of SOC. Product acquisition costs for HEMOPATCH and SOC were included along with outcome-related costs derived from the literature and inflation-adjusted to 2017 EUR and GBP. Results are presented for an average hospital with an annual case load of 574 cardiac surgeries. One-way and probabilistic sensitivity analyses were performed. RESULTS: Considering only product acquisition cost, HEMOPATCH had an incremental cost-effectiveness ratio (ICER) of €1,659, €1,519, €1,623, and £1,725 per hemostasis success when compared to SOC for Italy, Spain, France, and the UK, respectively. However, when considering the cost and potential difference in the frequency of transfusions and revisions compared to SOC, the use of HEMOPATCH was associated with an annual reduction of six revisions and 60 transfusions, improving the ICER to €1,440, €1,222, €1,461, and £1,592, respectively. Sensitivity analysis demonstrated model robustness. CONCLUSIONS: This analysis supports the use of HEMOPATCH over SOC in cardiac surgery in European hospitals to improve hemostasis success rates and potential cost offsets from reduced transfusions, complications, and surgical revisions.

Clinical symptoms that predict the presence of Obstructive Sleep Apnea.

OBJECTIVE: To determine if a set of clinical symptoms can help in determining the presence and severity of OSA. SETTING: Tertiary urban pediatric hospital. METHODS: Parents of children undergoing an overnight PSG answered a 56 item questionnaire based on their child's symptoms. The responses to the questionnaire were compared between patients with different severities of OSA (s determined by PSG) and those without OSA. Responses to questionnaire were also analyzed between obese and non-obese patients. RESULTS: 235 children were included (140 male and 95 female) with a mean age of 5.76 ± 2.78 years. The mean Apnea Hypopnea Index (AHI) was 7.78 ± 14.50 events/hour (range 0-110 events/h). 74 (31.5%) children had mild-OSA (AHI between 1 and 4.99 events/h), 31 (13.19%) had moderate-OSA (AHI between 5 and 9.99 events/h), 58 (24.7%) had severe-OSA (AHI≥10events/h) and the remaining 72 (30.64%) had No-OSA (AHI≤1event/h). 87 (37%) patients were obese. Eight clinical symptoms in non-obese and six clinical symptoms in obese patients predicted the mild to severe OSA. Sixteen symptoms in non-obese patients and nine symptoms in obese patients predicted the presence of severe OSA in these patients. CONCLUSION: Clinical symptoms reported in this study are useful to predict the presence of and the severity of OSA in children. Clinical symptoms can also predict the presence and severity of OSA in children who are obese, however, the symptoms required to make the prediction are different in obese children.

Comparison of Efficacy and Complications Among Various Spacer Grafts in the Treatment of Lower Eyelid Retraction: A Systematic Review.

BACKGROUND: Lower eyelid retraction is a difficult problem to treat, but it is a prevalent condition and a common complication of blepharoplasty. The use of spacer grafts to increase eyelid height and improve symptoms has been described for a long time, but the optimal choice of spacer graft material is unknown. OBJECTIVES: The authors reviewed the currently available evidence to determine the best available spacer graft material in terms of efficacy and complications. METHODS: A systematic review of all available literature published between 1985 and the present was performed using the Pubmed, Ovid MEDLINE, and Cochrane library databases. Inclusion criteria were that the studies contain original content assessing the treatment of lower eyelid retraction in humans using a spacer graft and provide quantitative outcomes data. RESULTS: One hundred and twelve articles were reviewed following an initial screen using titles, and 19 articles were chosen for inclusion in this systematic review. Analysis of these articles revealed no spacer graft material that is clearly superior to others. CONCLUSIONS: Due to a lack of high quality evidence, this review did not reveal one spacer graft material that is clearly superior to others. However, a narrative summary of the available evidence reveals unique sets of advantages and disadvantages associated with the various materials currently available. Further research in the form of well-designed studies will be necessary to further clarify advantages of certain spacer graft materials over others. LEVEL OF EVIDENCE: 5.

Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents.

BACKGROUND: Clinical studies investigating topical hemostatic agents have not used standardized definitions for intraoperative bleeding. The Food and Drug Administration has recently sought use of a validated, clinician-reported scale to standardized bleeding sites in these clinical studies. The intent of a scale is to reduce patient risk, generate labeling claims, and allow comparisons among study results. We describe the development and validation of an intraoperative bleeding severity scale. METHODS: A concept phase defined the framework of the scale. A feasibility and validation phase investigated the usability, clarity, relevance, and reliability (ie, intra- and interobserver concordance) among surgeons and surgical specialties as required by the Food and Drug Administration for the validation of a clinician-reported scale. Data were collected using an online tool. A total of 144 surgeons participated in the 3 phases. RESULTS: The scale developed during the concept phase achieved an average intraobserver concordance of 0.97 and an interobserver concordance of 0.89 in the feasibility phase (N = 33); a concordance of 1.0 is perfect. The scale was refined and then achieved an average intraobserver concordance of 0.98 and an interobserver concordance of 0.91 in the validation phase with unanimous agreement by surgeons from multiple surgical specialties that the scale can be implemented into clinical studies (N = 102). CONCLUSION: This study validated an intraoperative bleeding severity scale for use in clinical studies investigating hemostatic agents. The scale was usable, clear, and clinically relevant with excellent reliability. The scale fulfills requirements of the Food and Drug Administration for a clinician-reported scale and can be used to generate clinically meaningful labeling claims.