Pharmacist biosimilar survey reveals knowledge gaps.

BACKGROUND: Biosimilars are of increasing significance to pharmacy practice, with the potential to improve patient access to biologic therapies and help reduce overall health care costs. OBJECTIVES: This web-based survey assessed pharmacists' understanding of biosimilars, including interchangeability. METHODS: WebMD LLC fielded a survey including true or false and Likert-type questions to the Medscape pharmacist and certified pharmacy technician (CPT) panel in March 2021. Those practicing in community, home care or infusion, hospital or health system, managed care, outpatient, or specialty pharmacy settings and currently providing prescription services, or formulary or benefit management related to biologic products were included, to a quota of 500 responses. Results were analyzed descriptively. RESULTS: Data are reported for 507 of 992 respondents (265 did not meet eligibility criteria, 220 responded after the survey closed), including 498 pharmacists and 9 CPTs. These respondents worked in a community setting (66%), outpatient or ambulatory or other setting (16%), hospital or health system setting (14%), or managed care (5%). Overall, 87% and 91% of respondents knew that the biosimilar had equivalent efficacy and safety, respectively, to its reference product. Only 20% understood that a pharmacist can substitute a Food and Drug Administration-approved interchangeable without approval of the prescriber. However, 53% responded that they felt it was appropriate for a pharmacist to dispense an interchangeable in place of its reference product without authorization from the prescriber if consistent with state law; a numerically smaller proportion of community pharmacists understood this concept than the other groups (50% vs. 54%-61%). Only 11% of respondents knew that no biosimilars were designated as interchangeable at the time of the survey, with a numerically greater proportion of managed care pharmacists showing awareness than other groups. Slightly more than 50% of respondents felt that they were moderately or very comfortable in responding to patients' biosimilar questions. CONCLUSION: Gaps remain in pharmacists' understanding and comfort with key concepts about biosimilar products, including interchangeability, suggesting the need for further education.

Randomized Controlled Trial of Scrotal versus Inguinal Orchidopexy on Postoperative Pain.

INTRODUCTION: To compare the impact of orchidopexy approach (scrotal vs inguinal) on analgesic requirements, postoperative pain scores and complication rates. MATERIALS AND METHODS: A superiority randomized controlled trial including boys 10 to 95 months of age at surgery, diagnosed with palpable undescended testis, was conducted. Patients with nonpalpable or bilateral undescended testis, previous inguinal surgery on the ipsilateral side and concurrent procedures were excluded. Block randomization with 1:1 allocation ratio and a standardized anesthesia protocol were employed. The primary outcome was postoperative pain and analgesic use in-hospital and at home using the validated pain scales FLACC (Face, Legs, Activity, Cry, and Consolability Behavioural Scale), CHEOPS (Children's Hospital of Eastern Ontario Pain Scale), PPPM (Parents Postoperative Pain Measure) and TPPPS (Toddler-Preschooler Postoperative Pain Scale). Secondary outcomes included operative time, conversion and success rates, and complications. An intention to treat protocol was followed. RESULTS: We enrolled 173 patients, and 12 withdrew. Of the 161 patients who completed followup, 80 had scrotal orchidopexy and 81 inguinal orchidopexy. In-hospital use of ibuprofen (p=0.02) and acetaminophen (p <0.01), as well as FLACC (p <0.01) and CHEOPS (p=0.04) pain scores were slightly higher in patients who underwent orchidopexy. No difference in mean operative time and median at-home administration of analgesic was noted. The conversion rate was 24% (19/80). Of these, 13 (68%) were canalicular testes. The overall complication rate was 4% (6/161): 1 testicular atrophy, 3 re-ascents and 2 wound infections. Of these, 5 underwent scrotal orchidopexy and 1 had inguinal orchidopexy (wound infection). CONCLUSIONS: Even though in-hospital mean postoperative pain scores and analgesic consumption were slightly lower for scrotal orchidopexy cases, the pain levels were mild across all scales. Median at-home analgesic use and pain scores were similar for both groups, as well as operative time and complication rates. Scrotal orchidopexy is an effective alternative to inguinal orchidopexy for low-lying undescended testis, as 68% of cases that needed conversion were canalicular testes.

Companion animal preventive care at a veterinary teaching hospital - Knowledge, attitudes, and practices of clients.

Preventive care is the cornerstone of health. However, veterinary staff to client (pet owner) communication of disease prevention may be limited resulting in increased pet risk. Our objectives were to evaluate knowledge, attitudes, and practices of clients regarding vaccination and parasite control and describe information sources influencing client preventive care. Over a 6-week period, clients visiting a veterinary teaching hospital in Prince Edward Island, Canada, were invited to complete a written questionnaire. Of those invited, 81% (105/129) completed the questionnaire. Respondents reported low (19 to 33%) to moderate (66 to 79%) coverage for canine "lifestyle" and core vaccines, respectively. Half of the participants reported that they had concern for their pet's health from endo/ectoparasites compared to concern for their/household member's health (27%), despite 45% reporting a person at increased zoonotic risk in their household. Veterinarians (89 to 92%) and online information (39 to 51%) were the highest client-reported resources for vaccine and parasite education. Our work provides a baseline for preventive care practices and highlights a need for improvement.

Soins préventifs des animaux de compagnie dans un hôpital d'enseignement vétérinaire ­ Connaissances, attitudes et pratiques des clients. Les soins préventifs sont la pierre angulaire de la santé. Cependant, la communication entre le personnel vétérinaire et le client (propriétaire de l'animal) concernant la prévention des maladies peut être limitée, ce qui augmente le risque pour les animaux de compagnie. Les objectifs de l'étude étaient d'évaluer les connaissances, les attitudes et les pratiques des clients en matière de vaccination et de lutte antiparasitaire et de décrire les sources d'information influençant les soins préventifs prodigués par les clients. Sur une période de 6 semaines, les clients visitant un hôpital d'enseignement vétérinaire de l'Île-du-Prince-Édouard, au Canada, ont été invités à remplir un questionnaire écrit. Parmi les invités, 81 % (105/129) ont rempli le questionnaire. Les répondants ont rapporté une couverture faible (19 à 33 %) à modérée (66 à 79 %) pour les vaccins « style de vie ¼ canin et de base, respectivement. La moitié des participants ont déclaré s'inquiéter pour la santé de leur animal de compagnie relativement aux endo/ectoparasites comparativement à des inquiétudes pour leur santé ou celle des membres de leur famille (27 %), bien que 45 % aient déclaré qu'une personne présentait un risque zoonotique accru dans leur ménage. Les vétérinaires (89 à 92 %) et les renseignements en ligne (39 à 51 %) étaient les ressources les plus importantes déclarées par les clients pour l'éducation sur les vaccins et les parasites. Notre travail fournit une base pour les pratiques de soins préventifs et met en évidence un besoin d'amélioration.(Traduit par Dr Serge Messier).

Gubernaculum Testis and Cremasteric Vessel Preservation during Laparoscopic Orchiopexy for Intra-Abdominal Testes: Effect on Testicular Atrophy Rates.

PURPOSE: Gubernaculum sparing laparoscopic orchiopexy, which involves anatomical delivery of the testis through the internal inguinal ring, has been proposed as an alternative to conventional laparoscopic Fowler-Stephens orchiopexy, maximizing collateral blood supply and potentially decreasing atrophy rates. We compared the 2 techniques to test this hypothesis. MATERIALS AND METHODS: The primary (dependent) outcome of the study was rate of testicular atrophy, which was defined as palpation of a nubbin or inability to palpate a testis (complete atrophy) on postoperative physical examination at 3 and 12 months. Doppler ultrasound was obtained routinely to further confirm the diagnosis of testicular atrophy. Independent variables that were captured were age at surgery, type of procedure (conventional laparoscopic Fowler-Stephens orchiopexy vs gubernaculum sparing laparoscopic orchiopexy), surgical approach (single vs 2-stage), location of intra-abdominal testis (high vs low) and patency of the internal inguinal ring. RESULTS: Mean ± SD age at surgery was 25.7 ± 13.3 months (median 22). Laparoscopy was carried out for nonpalpable testes and revealed vanishing intra-abdominal testes in 120 cases (29%), peeping testes in 80 (19%) and intra-abdominal testes in 212 (51%), with 104 being low and 108 being high in the abdomen. A single stage procedure was performed in 44 cases (21%) and a 2-stage procedure in 168 (79%). Based on surgeon preference, conventional laparoscopic Fowler-Stephens orchiopexy was undertaken in 46 patients (22%) and gubernaculum sparing laparoscopic orchiopexy in 166 (78%). Overall testicular atrophy rate was 6.6% (14 of 212 cases). Atrophy was observed in 13 of 46 testes after conventional laparoscopic Fowler-Stephens orchiopexy and 1 of 166 following gubernaculum sparing laparoscopic orchiopexy (28.3% vs 0.6%, p <0.01). CONCLUSIONS: Gubernaculum sparing laparoscopic orchiopexy is a feasible alternative to conventional laparoscopic Fowler-Stephens orchiopexy. Our findings suggest that preservation of additional vascular supply to the testis (cremasteric vessels and deferential artery) may translate into improved testicular survival rates following laparoscopic orchiopexy.

Society for Fetal Urology Classification vs Urinary Tract Dilation Grading System for Prognostication in Prenatal Hydronephrosis: A Time to Resolution Analysis.

PURPOSE: The Urinary Tract Dilation grading system for prenatal hydronephrosis was introduced to address potential shortcomings of the Society for Fetal Urology classification. Hydronephrosis resolution is an important patient outcome and is frequently discussed during family counseling. We compared these 2 grading systems and their ability to predict time to hydronephrosis resolution. MATERIALS AND METHODS: We prospectively screened 855 patients with prenatal hydronephrosis due to ureteropelvic junction obstruction-like hydronephrosis, nonrefluxing primary megaureter or vesicoureteral reflux between 2009 and 2015. Of the patients 454 were excluded due to surgery, late referral, absence of postnatal dilatation or presence of other anomalies, resulting in 401 eligible patients (of whom 81% were male) to be included for analyses. Hydronephrosis grades collected at baseline and last followup were compared to identify resolution trends through time. Hydronephrosis resolution was defined as renal pelvis anteroposterior diameter 10 mm or less at last followup. Time to resolution was analyzed using Cox proportion regression. RESULTS: Of 401 patients 328 (82%) had resolution during a mean ± SD followup of 24 ± 18 months (maximum 107). Cumulative resolution rate at 3 years was 98% for Society for Fetal Urology grade I hydronephrosis, 87% for grade II, 76% for grade III and 57% for grade IV. The 3-year hydronephrosis resolution rate was 90% for Urinary Tract Dilation postnatal grade 1 (low risk), 81% for grade 2 (intermediate risk) and 71% for grade 3 (high risk). CONCLUSIONS: Patients with distinctive baseline hydronephrosis grades (classified by Society for Fetal Urology or Urinary Tract Dilation system) had significantly different resolution times for hydronephrosis (p <0.001). Counseling families regarding time to resolution of prenatal hydronephrosis should remain the same whether using Society for Fetal Urology or Urinary Tract Dilation grading system.

Associations of Initial Society for Fetal Urology Grades and Urinary Tract Dilatation Risk Groups with Clinical Outcomes in Patients with Isolated Prenatal Hydronephrosis.

PURPOSE: There are limited comparative data on the predictive value of the 2 most commonly used classification systems, that is SFU (Society for Fetal Urology) hydronephrosis grades and urinary tract dilatation risk groups, in regard to the future risk of surgical intervention and the development of febrile urinary tract infection. We explored this topic in infants with isolated hydronephrosis. MATERIALS AND METHODS: After screening 938 patients with prenatal hydronephrosis from 2009 to 2016 we selected 322 patients with ureteropelvic junction obstruction-like hydronephrosis for study. Hydronephrosis grades were prospectively collected at baseline, surgery and last followup. Gender, circumcision status, antibiotic prophylaxis and renal pelvis anteroposterior diameter were captured. The primary outcome was pyeloplasty and the development of febrile urinary tract infection. Comparative analyses between SFU grades/urinary tract dilatation groups and the primary outcome were performed with the Fisher exact and log rank tests. RESULTS: Mean ± SD age at presentation was 3.3 ± 2.6 months and mean followup was 22 ± 19 months. Pyeloplasty was performed in 32% of patients with SFU III/IV vs 31% with urinary tract dilatation 2/3. The rate of febrile urinary tract infection in patients with SFU III/IV was similar to that in those with urinary tract dilatation group 2/3 (8% vs 10%). Children with SFU III/IV showed a significantly higher rate of surgery than those with SFU I/II (32% vs 2%, p <0.01). Similar findings were seen when using urinary tract dilatation groups to compare patients at low risk (1) vs moderate/high risk (2/3). CONCLUSIONS: Both grading systems equally allowed for proper risk stratification and prediction of clinical outcomes based on baseline ultrasound. They correctly separated most infants who underwent surgery or in whom febrile urinary tract infection developed from those who could be treated nonsurgically. Use of the new urinary tract dilatation classification should not affect how families of children with isolated hydronephrosis are counseled regarding surgical intervention and the risk of febrile urinary tract infection.

Cause and Effect versus Confounding-Is There a True Association between Caudal Blocks and Tubularized Incised Plate Repair Complications?

PURPOSE: We studied the impact of caudal block vs dorsal penile block on the rate of urethrocutaneous fistula and glans dehiscence in children who underwent hypospadias repair. MATERIALS AND METHODS: We retrospectively reviewed the records of 849 consecutive patients who underwent tubularized incised plate repair between 2004 and 2015. A total of 331 cases with incomplete medical records, other techniques and redo repair were excluded. The preference for caudal block was based on anesthesiologist discretion. Age at surgery, meatal location, preoperative testosterone stimulation, type of regional anesthesia (caudal block vs dorsal penile block), degree of ventral curvature, surgeon expertise and complications (urethrocutaneous fistula/glans dehiscence) were captured. Univariate and multivariable analyses were done of risk factors for complications. RESULTS: Median age at surgery was 18 months and median followup was 6 months. Of 518 patients 405 (78%) had distal and 113 (22%) had mid shaft/proximal defects. Complications developed in 37 cases (7%), including urethrocutaneous fistula in 21 (19 with a caudal block and 2 with a dorsal penile block) and glans dehiscence in 16 (13 with a caudal block and 3 with a dorsal penile block). On univariate analysis preoperative testosterone stimulation vs no preoperative testosterone stimulation (13.0% vs 6.2% of cases, p = 0.04), mid shaft/proximal vs distal defects (15.9% vs 4.7%, p <0.01) and caudal block (8.7% vs 3.3%, p = 0.03) were significantly associated with more complications. However, on multivariable analysis the associations of preoperative testosterone stimulation (OR 1.2, 95% CI 0.4-3.7) and caudal block (OR 2.4, 95% CI 0.9-6.4) with complications did not hold. Only the combination of meatal location/ventral curvature remained as an independent risk factor for urethrocutaneous fistula/glans dehiscence (OR 2.4, 95% CI 1.1-5.7, p = 0.04). CONCLUSIONS: Our data indicate that hypospadias severity and not the type of regional anesthesia was the only risk factor significantly associated with postoperative complications. To confirm these findings and provide strong and definitive evidence on this topic a well powered, randomized, controlled trial is clearly required.

Orbital apocenter is not a sufficient condition for HST/STIS detection of Europa's water vapor aurora.

We report far-ultraviolet observations of Jupiter's moon Europa taken by Space Telescope Imaging Spectrograph (STIS) of the Hubble Space Telescope (HST) in January and February 2014 to test the hypothesis that the discovery of a water vapor aurora in December 2012 by local hydrogen (H) and oxygen (O) emissions with the STIS originated from plume activity possibly correlated with Europa's distance from Jupiter through tidal stress variations. The 2014 observations were scheduled with Europa near the apocenter similar to the orbital position of its previous detection. Tensile stresses on south polar fractures are expected to be highest in this orbital phase, potentially maximizing the probability for plume activity. No local H and O emissions were detected in the new STIS images. In the south polar region where the emission surpluses were observed in 2012, the brightnesses are sufficiently low in the 2014 images to be consistent with any H2O abundance from (0-5)×10(15) cm(-2). Large high-latitude plumes should have been detectable by the STIS, independent of the observing conditions and geometry. Because electron excitation of water vapor remains the only viable explanation for the 2012 detection, the new observations indicate that although the same orbital position of Europa for plume activity may be a necessary condition, it is not a sufficient condition. However, the December 2012 detection of coincident HI Lyman-α and OI 1304-Å emission surpluses in an ∼200-km high region well separated above Europa's limb is a firm result and not invalidated by our 2014 STIS observations.

The conundrum of high-grade hydronephrosis with non-obstructive drainage on diuretic renography.

BACKGROUND: Patients with high grade hydronephrosis (HN) and non-obstructive drainage on mercaptoacetyltriglycine (MAG-3) diuretic renography (renal scans) can pose a dilemma for clinicians. Some patients may progress and require pyeloplasty; however, more clarity is needed on outcomes among these patients. OBJECTIVE: Our primary objective was to predict which patients with high-grade HN and non-obstructive renal scan, (defined as T ½ time <20 min) would experience resolution of HN. Our secondary objective was to determine predictors for surgical intervention. STUDY DESIGN: Patients with prenatally detected HN were prospectively enrolled from 7 centers from 2007 to 2022. Included patients had a renal scan with T ½<20 min and Society for Fetal Urology (SFU) grade 3 or 4 at last ultrasound (RBUS) prior to renal scan. Primary outcome was resolution of HN defined as SFU grade 1 and anterior posterior diameter of the renal pelvis (APD) < 10 mm on follow-up RBUS. Secondary outcome was pyeloplasty, comparing patients undergoing pyeloplasty with patients followed with serial imaging without resolution. Multivariable logistic regression was used for analysis. RESULTS: Of the total 2228 patients, 1311 had isolated HN, 338 patients had a renal scan and 129 met inclusion criteria. Median age at renal scan was 3.1 months, 77% were male and median follow-up was 35 months (IQR 20-49). We found that 22% (29/129) resolved, 42% of patients had pyeloplasty (54/129) and 36% had persistent HN that required follow-up (46/129). Univariate predictors of resolution were age≥3 months at time of renal scan (p = 0.05), T ½ time≤5 min (p = 0.09), SFU grade 3 (p = 0.0009), and APD<20 mm (p = 0.005). Upon multivariable analysis, SFU grade 3 (OR = 4.14, 95% CI: 1.30-13.4, p = 0.02) and APD<20 mm (OR = 6.62, 95% CI: 1.41-31.0, p = 0.02) were significant predictors of resolution. In the analysis of decision for pyeloplasty, SFU grade 4 (OR = 2.40, 95% CI: 1.01-5.71, p = 0.04) and T ½ time on subsequent renal scan of ≥20 min (OR = 5.14, 95% CI: 1.54-17.1, p = 0.008) were the significant predictors. CONCLUSIONS: Patients with high grade HN and reassuring renal scan can pose a significant challenge to clinical management. Our results help identify a specific candidate for observation with little risk for progression: the patient with SFU grade 3, APD under 20 mm, T ½ of 5 min or less who was 3 months or older at the time of renal scan. However, many patients may progress to surgery or do not fully resolve and require continued follow-up.

Non-refluxing Primary Megaureter in Children Resolves From Proximal to Distal.

OBJECTIVES: To evaluate a population of children with non-refluxing primary megaureter (NRPM), we investigated spontaneous resolution of ureteral dilation and the pattern (proximal to distal or distal to proximal) in which it occurs. METHODS: From our prospectively collected prenatal hydronephrosis (HN) database (0-24 months, 2008-2017), selecting those with NRPM (n = 92). We excluded patients who underwent surgery (n = 20), children with <6 months follow-up (n = 2) and without a voiding cystourethrogram (VCUG) (n = 4). Images were segregated into 198 ureteric segments (proximal/mid/distal). We defined resolution as Society for Fetal Urology (SFU) (0/1), anteroposterior diameter (APD) <10 mm, and ureteric dilatation <5 mm. Descriptive statistics and Kaplan-Meier curves were created for time-to-resolution analyses. RESULTS: Of 66 patients and 198 ureteral segments, median age at presentation was 2 months (0-12), 83% were male (33% circumcised). Mean APD at baseline was 11 ± 4 mm, and 79% had (SFU 3/4) HN. Mean dilatation of ureteral segments (mm) at baseline was: 9 ± 2 proximal, 9 ± 2 mid, and 11 ± 3 distal. At a median follow-up time of 26 (7-83) months, dilation of 55 (83%) proximal, 48 (72%) mid, and 22 (33%) distal ureteric segments had resolved. Overall, HN resolution occurred in 76% of patients. Resolution rates were similar for proximal/mid-ureters (83% vs 72%; P = .20); however, they were significantly different from distal segments (83% proximal vs 33% distal; 72% mid vs 33% distal, P <.01). CONCLUSION: Our data suggest that spontaneous resolution of NRPM follows a proximal to distal progression. Distal ureteric dilatation takes up to 10 months longer to resolve compared to that of proximal and mid-ureteric segments, as well as that of the renal pelvis.

Association of the Hydronephrosis Severity Score With Likelihood of Pyeloplasty: A Large Prospective Database Analysis.

OBJECTIVE: To apply and reproduce this scoring system in our prenatal hydronephrosis population with ureteropelvic junction obstruction (UPJO)-like hydronephrosis (HN), specifically looking at determining better HHS cutoffs that would allow for stratification into three risk categories: spontaneous HN resolution, observation, and surgery. METHODS: A prospectively collected prenatal hydronephrosis database was reviewed to extract UPJO-like HN patients. Children with vesicoureteral reflux, primary megaureter, bilateral HN, and other associated anomalies were excluded. Only patients who had an ultrasound and mercaptoacetyltriglycine renal scan at a minimum of 2-time points were included. Hydronephrosis Severity Score was calculated at the initial, interim, and last follow-up clinic visits. Scores were analyzed regarding its usefulness to determine which patients would have been more likely to undergo pyeloplasty. RESULTS: Of 167 patients, 131 (78%) were male, 119 (71%) had left UPJO-like, and 113 (67%) had a pyeloplasty. The median age at baseline was 2months (interquartile range 1-4). According to initial (first clinic visit) Hydronephrosis Severity Score, 5/36 (14%) patients with a 0-4 score, 93/116 (80%) with a 5-8 score, and 15/15 (100%) with a 9-12 score underwent pyeloplasty, respectively (P < .01). CONCLUSION: The proposed HHS system for UPJO-like HN patients is reproducible, however, cut-off values need to be reassessed to accurately reflect true risk categories, as the purpose of this system is to differentiate those who have HN severe enough to require intervention from those who can be managed nonsurgically. Changing risk groups to mild (0-3), moderate (4-6), and severe (7-12) allowed for better discrimination between patients who underwent surgical intervention from those who did not in our dataset.

Buccal Mucosa Vaginoplasty Through an Anterior Sagittal Transrectal Approach (ASTRA) for Management of Yolk Sac Tumor in a 3-Year-Old Girl.

Vaginal yolk sac tumors are rare pediatric malignant tumors and the most common form of vaginal germ-cell tumors in children. They are almost exclusively found in females under 3 years of age. Treatment involves local excision either with or without chemotherapy. Herein, we describe a case of a 3-year-old girl with vaginal Yolk sac tumor, who underwent buccal mucosa vaginoplasty through an anterior sagittal transrectal approach , as an effective oncological procedure, with preservation of reproductive function.

An online survey among US patients with immune-mediated conditions: Attitudes about biosimilars.

BACKGROUND: Few surveys about biosimilars have been conducted among US patients. OBJECTIVE: To evaluate attitudes about biosimilars among patients with rheumatoid arthritis (RA), psoriasis and/or psoriatic arthritis (PsO/A), and/or inflammatory bowel disease (IBD). METHODS: WebMD, LLC fielded a 16-item online survey to members of the US Dynata consumer panel meeting these criteria: aged 18 years or older; self-reported specialist diagnosis of RA, PsO/A, or IBD of at least 1 year; and not currently receiving an infliximab biosimilar. A quota of 500 was set, stratified by region and condition. The survey was exempt by the institutional review board, exploratory, and not registered. RESULTS: Overall, 44% (n = 221) of patients were on a biologic; 56% (n = 279) were not on a biologic (40% [n = 199] were biologic naive and 16% [n = 80] used biologics in the past). Among all patients, 66% were unaware of biosimilars and 24% were aware (10% unsure). After being shown the US Food and Drug Administration definition of a biosimilar, main concerns were side effects (59%), long-term safety (50%), and not knowing a lot (46%). Among current users, 43% would switch to a biosimilar and 26% would not (32% unsure). Of those unwilling to switch, 51% were concerned about side effects, 42% about financial support, and 40% about efficacy. When those not on a biologic were asked if their doctor prescribed an original anti-tumor necrosis factor α but their insurance required its biosimilar, 49% would switch and 8% would not (43% unsure). 51% of patients surveyed thought pharmacist-level substitution of an interchangeable biosimilar was acceptable with notification. Survey findings were consistent among the RA, PsO/A, and IBD subgroups. CONCLUSIONS: Although two-thirds of patients surveyed were unaware of biosimilars, the majority were potentially receptive to biosimilar treatment after being provided with the definition of a biosimilar. Patients expressed a desire to know more about biosimilars in general, how they compare with original biologics, their benefits, and cost. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals Inc. (BIPI). WebMD, LLC, fielded the survey. BIPI was given the opportunity to review the article for medical and scientific accuracy and intellectual property considerations. Dr Gibofsky is a consultant/advisor for AbbVie Inc., Biosplice Therapeutics, Lilly, Novartis Pharmaceuticals Corporation, and Pfizer Inc., and he is on the speakers' bureau for AbbVie Inc., Amgen, Lilly, and Pfizer Inc., and has stock ownership in AbbVie Inc., Amgen, Bristol-Myers Squibb Company, Horizon Pharma plc, and Pfizer Inc. Dr Peyrin-Biroulet reports that he has received personal consulting fees from Merck Sharp & Dohme, AbbVie, Janssen, Takeda, Celltrion, Pfizer, Bristol-Myers Squibb Company, Pharmacosmos, Shire, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, UCB-Pharma, Hospira, BIPI, and Lilly. Dr McCabe is an employee of BIPI. Dr McGrath was an employee of BIPI at the time the survey was conducted. Mr Jacobson, Mr Franklin, and Ms O'Hara-Levi report no disclosures.

Identifying variability in surgical practices and instrumentation for hypospadias repair across the Western Pediatric Urology Consortium (WPUC) network.

BACKGROUND: Although hypospadias outcomes studies typically report a level or type of repair performed, these studies often lack applicability to each surgical practice due to technical variability that is not fully delineated. An example is the tubularized incised plate (TIP) urethroplasty procedure, for which modifications have been associated with significantly decreased complication rates in single center series. However, many studies fail to report specificity in techniques utilized, thereby limiting comparison between series. OBJECTIVE: With the goal of developing a surgical atlas of hypospadias repair techniques, this study examined 1) current techniques used by surgeons in our network for recording operative notes and 2) operative technical details by surgeon for two common procedures, tubularized incised plate (TIP) distal and proximal hypospadias repairs across a multi-institutional surgical network. STUDY DESIGN: A two-part study was completed. First, a survey was distributed to the network to assess surgeon volume and methods of recording hypospadias repair operative notes. Subsequently, an operative template or a representative de-identified operative note describing a TIP and/or proximal repair with urethroplasty was obtained from participating surgeons. Each was analyzed by at least two individuals for natural language that signified specified portions of the procedure. Procedural details from each note were tabulated and confirmed with each surgeon, clarifying that the recorded findings reflected their current practice techniques and instrumentation. RESULTS: Twenty-five surgeons from 12 institutions completed the survey. The number of primary distal hypospadias repairs performed per surgeon in the past year ranged from 1-10 to >50, with 40% performing 1-20. Primary proximal hypospadias repairs performed in the past year ranged from 1-30, with 60% performing 1-10. 96% of surgeons maintain operative notes within an electronic health record. Of these, 66.7% edited a template as their primary method of note entry; 76.5% of these surgeons reported that the template captures their operative techniques very or moderately well. Operative notes or templates from 16 surgeons at 10 institutions were analyzed. In 7 proximal and 14 distal repairs, parameters for chordee correction, urethroplasty suture selection and technique, tissue utilized, and catheter selection varied widely across surgeons. CONCLUSION: Wide variability in technical surgical details of categorically similar hypospadias repairs was demonstrated across a large surgical network. Surgeon-specific modifications of commonly described procedures are common, and further evaluation of short- and long-term outcomes accounting for these technical variations is needed to determine their relative influence.

A survey of parental perceptions and attitudes related to disclosure in hypospadias repair.

INTRODUCTION: Boys with hypospadias often undergo reconstructive surgery to improve cosmetic appearance and functional outcomes. While the ethics of physician-patient disclosure of illness are clear, parent-child disclosure is more ambiguous. There is a paucity of research regarding the parental disclosure of past urological procedures, specifically hypospadias repair. Our objective was to determine the rate of parental disclosure in boys undergoing hypospadias repair, and to evaluate the parental perspectives regarding concerns and amount of support in relation. METHODS: A web-based questionnaire was distributed to parents of 240 hypospadias patients at our pediatric urology outpatient clinic over 12 months. The questionnaire assessed intent to disclose, decisional regret, and cosmetic perception. Data was analyzed using descriptive statistics and chi-square analyses. RESULTS: Two hundred and twenty-three survey responses were collected. The majority of respondents were urban dwellers (72.2%), and the mothers of the child (80.9%). Distal hypospadias was the most common variant of condition (62.7%). When asked if they plan to disclose the repair to their child, 93% said "yes", and of those, the optimal mean age of disclosure was 7.49 ± 4.30 years. Ninety percent reported that they were not offered guidance on how/when to disclose, and 43% thought they would benefit from support on this. There was a significant difference in nervousness to disclose if the condition was distal versus proximal (χ2 = 15.19, p=<0.01), with proximal being more nervous. A significant difference was also observed regarding disclosure support with proximal being more likely to want formal support (χ2 = 4.55, p = 0.03). DISCUSSION AND CONCLUSIONS: As hypothesized, the majority of parents intended to disclose their son's surgery to them, but no statistically significant difference was seen between those with a distal vs. proximal repair. Additionally, demographic characteristics which were hypothesized to influence this decision (e.g., parents' level of education and relationship to the child) did not discriminate parental intent to disclose. To our knowledge, this is the first study to evaluate perceptions and attitudes around disclosure in patients with hypospadias and their families. The majority of respondents were planning to disclose the operation to their child, and were not offered any guidance or support as to the optimal way to disclose. Half of those parents thought they could benefit from resources to help them with this process. Further research is required to understand the impact of disclosure and to create tools to help caregivers with this responsibility.

Nephron-Sparing Approach For Familial Bilateral Synchronous Wilms Tumors.

Wilms tumors are the most common renal malignancy of childhood, often presenting as asymptomatic abdominal masses. These tumors can occur either in a unilateral or bilateral fashion, with bilateral tumors more commonly associated with various genetic syndromes and familial inheritance with some known loci. Bilateral tumors present challenges with regards to balancing oncologic control with renal function. Here, we present an unusual case of a young female patient diagnosed with bilateral Wilms tumors on the background of a strong family history and unknown genetic loci.

Continuous antibiotic prophylaxis in isolated prenatal hydronephrosis.

BACKGROUND: Prenatal hydronephrosis (PNH) is one of the most common congenital anomalies and can increase the risk of developing a urinary tract infection (UTI) in the first two years of life. Continuous antibiotic prophylaxis (CAP) has been recommended empirically to prevent UTI in children with PNH, but its use has been controversial. OBJECTIVE: We describe the incidence of UTI in children with isolated PNH of the renal pelvis without ureteral dilation. Our objective was to compare patients receiving and not receiving CAP and determine whether CAP is beneficial at preventing UTI in children with isolated PNH. STUDY DESIGN: Children with confirmed PNH were enrolled between 2008 and 2020 into the Society for Fetal Urology Hydronephrosis Registry. Children with isolated dilation of the renal pelvis without ureteral or bladder abnormality were included. The primary outcome was development of a UTI, comparing patients who were prescribed and not prescribed CAP. RESULTS: In this cohort of 801 children, 76% were male, and 35% had high grade hydronephrosis (SFU grades 3-4). CAP was prescribed in 34% of children. The UTI rate among all children with isolated PNH was 4.2%. Independent predictors of UTI were female sex (HR = 13, 95% CI: 3.8-40, p = 0.0001), intact prepuce (HR = 5.1, 95% CI: 1.4-18, p = 0.01) and high grade hydronephrosis (HR = 2.0, 95% CI: 0.99-4.0, p = 0.05; Table) on multivariable analysis. For patients on CAP, the UTI rate was 4.0% compared to 4.3% without CAP (p = 0.76). The risk of UTI during follow-up was not significantly different between patients who received CAP and patients who were not exposed to CAP; adjusting for sex, circumcision status and hydronephrosis grade (HR = 0.72, 95% CI: 0.34-1.5, p = 0.38). In sub-group analysis of patients at higher risk of UTI (uncircumcised males, females and high grade hydronephrosis), CAP use was not associated with a statistically significant reduction in UTI. CONCLUSIONS: The overall UTI rate in children with isolated PNH is very low at 4.2%. In the overall population of patients with isolated PNH, CAP was not associated with reduction in UTI risk, although the limitations in our study make characterizing CAP effectiveness difficult. Clinicians should consider risk factors prior to placing all patients with isolated PNH on CAP.

Quality of reporting for pilot randomized controlled trials in the pediatric urology literature-A systematic review.

BACKGROUND: The conduct and reporting of pilot studies is important to assess the feasibility of future randomized controlled trials (RCT). The Consolidated Standards of Reporting Trials (CONSORT) statement extension to pilot/feasibility studies addresses the reporting quality of the pilot studies (Summary Table 1). The aims of this systematic review are (1) to assess the reporting quality of pilot studies in pediatric urology and (2) to explore the factors that are associated with the reporting quality of these studies. METHODS: A comprehensive search was conducted through MEDLINE® and EMBASE® to identify pilot RCTs from 2005 to 2018. Two reviewers independently performed title and abstract screening and full text review, with discrepancies resolved by consensus. CONSORT extension reported items were summarized and overall proportion of reported items for each article was estimated. A linear regression model was conducted to determine factors associated with higher reporting quality. Publication year, biostatistician/epidemiologist support, sample size justification and journal impact factor were collected. RESULTS: Of the 1463 titles duplicates were removed and 1347 were screened, 36 studies were included. Overall, 36 pilot studies reported about 8-9 of 17 items [51% (95% CI: 46 - 56%)]. The most reported items were contact details for the corresponding author (97%), title identification of study as randomised pilot or feasibility trial (95%), eligibility criteria and setting (81%), both interventions (78%), and specific objectives of the pilot trial (75%). Less fulfilled items were blinding (11%), registration of the trial (11%), randomization details (28%), detailing recruitment status in the pilot study (19%), trial design (31%), and source of funding for pilot trial (34%). Interpretation of the results of pilot trial and their implications for the future definitive trial was reported by 34% of the studies. Factors associated with higher reporting quality were the presence of biostatistician or epidemiologist (P = 0.004), and if the sample size for the pilot study was justified (P = 0.002). DISCUSSION: Overall reporting quality of pilot studies in pediatric urology literature from 2005-2018 was suboptimal. The quality of pilot RCTs included in the present review were lower than that observed in the orthopedic literature, however, it appears to be consistent with the trends regarding OQS in chronic kidney disease and allopathic medicine. While we endeavoured to maintain utmost rigidity of this systematic review, there are inherent limitations. The CONSORT 2010 extension for pilot RCTs was published in 2016. Clinical trials can take several years, many pilot studies published pre-2016 would not have had the guidance of the extension during designing phases. Not all pilot RCTs are published, so this could potentially reduce the generalizability of the findings from this review. Only studies in English, published in full peer-reviewed journals were included, and this review only addressed the reporting quality of pilot studies in pediatric urology. CONCLUSION: This review demonstrated that reporting quality of pilot studies in pediatric urology is currently suboptimal. Including biostatistician and/or epidemiologist, can ameliorate the quality of future pilot studies. Implementing CONSORT 2010 extension by journals as a prerequisite for submission of pilot or feasibility trials is recommended to improve the robustness and transparency of future pilot studies.

Evaluating the literature on preoperative androgen stimulation for hypospadias repair using the fragility index - can we trust observational studies?

BACKGROUND: Preoperative androgen stimulation (PAS) is typically used in hypospadias repair for patients with a proximal meatus or small glans size. Hypospadias PAS literature suffer from small sample sizes and lack of power to claim robust conclusions. Small changes in the number of events may completely change the statistical significance, making the conclusions drawn unreliable. Fragility index (FI) is the number of additional events needed to occur in either the control or experimental group to turn a statistically significant result to a non-significant result. The objective of the report was to assess the quality of available literature revolving around PAS use in hypospadias repair and its effects on post-operative complication rates using FI. METHODS: A comprehensive search of MEDLINE, EMBASE, and grey literature (ESPU and SPU abstracts) was conducted to identify RCTs and observational studies investigating the effect of PAS on complications post-hypospadias repair between 1990 and 2020. The FI was calculated for each study. Postoperative complications were defined as: fistula, stricture/stenosis, diverticula, and dehiscence. The odds ratio (OR), 95% confidence intervals (CI), corresponding p-values was calculated for each study. A random effects mixed model was implemented to combine the ORs for each study design. RESULTS: Fourteen studies qualified for inclusion, of which nine were observational studies and five were RCTs (Figure 1). The median sample size was 110 patients (IQR 69-171). The summary ORs for observational studies was 1.74 (95% CI: 1.10 to 2.74; p = 0.020) and for RCTs was 0.71 (9% CI: 0.34 to 1.47; p = 0.350). The median FI was 0 (IQR 0-2) of the included studies. DISCUSSION: PAS use does not appear to significantly affect complication rates shown in RCTs, however, observational studies cumulatively suggested significantly greater odds of complications after PAS. The FI is best used for RCTs with 1-to-1 randomization and binary data. Observational studies are rarely balanced for demographics and comorbidities with unequal sample size between comparable groups. The study was limited by substantial variability in how PAS was delivered to patients, leading to restricted comparability. CONCLUSION: Strong conclusions regarding the influence of PAS on hypospadias repair outcomes cannot be properly drawn based on the current literature due to deficits from either a statistical or methodological standpoint. The current PAS literature has shown inconclusive results, calling for well-designed RCTs, involving standardized surgical techniques and PAS protocols, to evaluate the true effect of PAS on complications post-hypospadias repair.