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1.
J Pediatr Urol ; 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38906709

RESUMO

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.

2.
Urology ; 182: 225-230, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37776954

RESUMO

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.


Assuntos
Hidronefrose , Ureter , Obstrução Ureteral , Criança , Gravidez , Feminino , Humanos , Masculino , Lactente , Recém-Nascido , Pelve Renal , Ureter/diagnóstico por imagem , Ureter/cirurgia , Dilatação Patológica , Estudos Retrospectivos
3.
Urology ; 177: 162-168, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37088315

RESUMO

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.


Assuntos
Hidronefrose , Ureter , Obstrução Ureteral , Criança , Gravidez , Feminino , Humanos , Masculino , Pré-Escolar , Pelve Renal/cirurgia , Resultado do Tratamento , Tomografia Computadorizada por Raios X , Hidronefrose/cirurgia , Hidronefrose/complicações , Obstrução Ureteral/diagnóstico , Obstrução Ureteral/cirurgia , Obstrução Ureteral/complicações , Estudos Retrospectivos
4.
J Manag Care Spec Pharm ; 29(4): 343-349, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36989450

RESUMO

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.


Assuntos
Artrite Psoriásica , Artrite Reumatoide , Medicamentos Biossimilares , Doenças Inflamatórias Intestinais , Psoríase , Masculino , Humanos , Medicamentos Biossimilares/uso terapêutico , Psoríase/tratamento farmacológico , Infliximab/uso terapêutico , Fatores Biológicos , Doenças Inflamatórias Intestinais/tratamento farmacológico
5.
J Pediatr Urol ; 19(3): 277-283, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36775718

RESUMO

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.


Assuntos
Hipospadia , Procedimentos de Cirurgia Plástica , Urologia , Criança , Masculino , Humanos , Lactente , Hipospadia/cirurgia , Resultado do Tratamento , Uretra/cirurgia , Procedimentos Cirúrgicos Urológicos Masculinos/métodos , Estudos Retrospectivos
6.
J Am Pharm Assoc (2003) ; 63(2): 529-537.e7, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36437154

RESUMO

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.


Assuntos
Medicamentos Biossimilares , Assistência Farmacêutica , Farmácia , Humanos , Medicamentos Biossimilares/uso terapêutico , Farmacêuticos , Inquéritos e Questionários
7.
Urology ; 173: e6-e9, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36572221

RESUMO

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.


Assuntos
Tumor do Seio Endodérmico , Neoplasias Embrionárias de Células Germinativas , Neoplasias Vaginais , Criança , Feminino , Humanos , Pré-Escolar , Tumor do Seio Endodérmico/cirurgia , Tumor do Seio Endodérmico/tratamento farmacológico , Mucosa Bucal , Vagina/cirurgia , Vagina/patologia , Neoplasias Vaginais/tratamento farmacológico
9.
J Pediatr Urol ; 18(3): 363.e1-363.e7, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35525823

RESUMO

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.


Assuntos
Hidronefrose , Infecções Urinárias , Antibioticoprofilaxia , Criança , Feminino , Humanos , Hidronefrose/complicações , Hidronefrose/congênito , Hidronefrose/epidemiologia , Lactente , Pelve Renal , Masculino , Fatores de Risco , Infecções Urinárias/epidemiologia , Infecções Urinárias/etiologia , Infecções Urinárias/prevenção & controle
10.
J Pediatr Urol ; 18(2): 178.e1-178.e7, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35181223

RESUMO

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.


Assuntos
Hipospadia , Procedimentos de Cirurgia Plástica , Atitude , Criança , Pré-Escolar , Tomada de Decisões , Revelação , Humanos , Hipospadia/cirurgia , Masculino , Pais , Inquéritos e Questionários
11.
Urology ; 160: 199-202, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34752848

RESUMO

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.


Assuntos
Neoplasias Renais , Tumor de Wilms , Feminino , Humanos , Neoplasias Renais/diagnóstico , Neoplasias Renais/genética , Neoplasias Renais/cirurgia , Masculino , Oncologia , Nefrectomia , Néfrons , Tumor de Wilms/diagnóstico , Tumor de Wilms/genética , Tumor de Wilms/cirurgia
12.
J Pediatr Urol ; 17(6): 846-854, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34635440

RESUMO

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.


Assuntos
Urologia , Criança , Estudos de Viabilidade , Humanos , Fator de Impacto de Revistas , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
J Pediatr Urol ; 17(6): 775-781, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34556410

RESUMO

BACKGROUND: Prenatal hydronephrosis is one of the most common anomalies detected on prenatal ultrasonography. Patients with prenatal hydronephrosis and ureteral dilation are at increased risk of urinary tract infection (UTI) and continuous antibiotic prophylaxis (CAP) is recommended. However, current guidelines do not define the minimum ureteral diameter that would be considered a dilated ureter in these patients. OBJECTIVE: We evaluate the definition of clinically relevant hydroureter, its association with UTI, and the impact of CAP. STUDY DESIGN: Patients with prenatal hydronephrosis from seven centers were enrolled into the Society for Fetal Urology Prenatal Hydronephrosis Registry from 2008 to 2020. Patients with ureteral measurement on ultrasound were included. Patients with ureterocele, ectopic ureter, neurogenic bladder, posterior urethral valves, horseshoe or solitary kidney, known ureteropelvic junction obstruction, or follow-up less than one month were excluded. Primary outcome was UTI. Analyses were performed using Cox regression. RESULTS: Of the 1406 patients enrolled in the registry, 237 were included. Seventy-six percent were male, ureteral diameter ranged from 1 to 34 mm, and median follow-up was 2.2 years. Patients with ureters 7 mm or greater had nearly three times the risk of UTI adjusting for sex, circumcision status, antibiotic prophylaxis and hydronephrosis grade (HR = 2.7, 95% CI: 1.1-6.5, p = 0.03; Figure). In patients who underwent voiding cystourethrogram (VCUG; 200/237), ureteral dilation of 7 mm or more identified patients at increased UTI risk controlling for sex, circumcision status, vesicoureteral reflux and hydronephrosis grade (HR = 2.3, 95% CI: 0.97-5.6, p = 0.06). CAP was significantly protective against UTI (HR = 0.50 (95% CI: 0.28-0.87), p = 0.01). Among patients who underwent VCUG and did not have vesicoureteral reflux, ureteral dilation 7 mm or greater corresponded with higher UTI risk compared to ureteral diameter less than 7 mm on multivariable analysis (HR = 4.6, 95% CI: 1.1-19.5, p = 0.04). CONCLUSIONS: This is the first prospectively collected, multicenter study to demonstrate that hydroureter 7 mm or greater identifies a high-risk group for UTI who benefit from antibiotic prophylaxis. In contrast, patients with prenatal hydronephrosis and non-refluxing hydroureter less than 7 mm may be managed more conservatively.


Assuntos
Hidronefrose , Infecções Urinárias , Urologia , Refluxo Vesicoureteral , Feminino , Humanos , Hidronefrose/diagnóstico por imagem , Hidronefrose/epidemiologia , Hidronefrose/etiologia , Lactente , Masculino , Gravidez , Sistema de Registros , Estudos Retrospectivos , Infecções Urinárias/epidemiologia , Infecções Urinárias/etiologia
14.
J Pediatr Urol ; 17(5): 661-669, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34518122

RESUMO

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.


Assuntos
Hipospadia , Procedimentos de Cirurgia Plástica , Androgênios , Humanos , Hipospadia/cirurgia , Masculino , Estudos Observacionais como Assunto , Complicações Pós-Operatórias/epidemiologia , Uretra/cirurgia
15.
Can Vet J ; 62(5): 484-490, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33967287

RESUMO

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).


Assuntos
Hospitais Veterinários , Médicos Veterinários , Animais , Canadá , Cães , Conhecimentos, Atitudes e Prática em Saúde , Hospitais de Ensino , Animais de Estimação , Ilha do Príncipe Eduardo , Inquéritos e Questionários
16.
J Urol ; 205(3): 895-901, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33021443

RESUMO

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.


Assuntos
Canal Inguinal/cirurgia , Orquidopexia/métodos , Dor Pós-Operatória/prevenção & controle , Escroto/cirurgia , Analgésicos/administração & dosagem , Criança , Pré-Escolar , Humanos , Lactente , Masculino , Ontário/epidemiologia , Medição da Dor , Dor Pós-Operatória/epidemiologia
17.
J Pediatr Urol ; 16(5): 708-711, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32900635

RESUMO

The evidence examining the effects of regional blocks on complications posthypospadias repair has been controversial. Nine observational studies have been published thus far, with inconsistent and somewhat contradictory results. In this educational article, we attempt to explain the concepts of study accuracy and precision in the context of the hypospadias literature to shed some light on the reasons behind those controversies. Methodological issues such as selection bias, confounding effect, sample size, confidence interval and study generalizability from studies involving dorsal penile block versus caudal epidural anesthesia in hypospadias repair are discussed.


Assuntos
Anestesia Caudal , Anestesia por Condução , Anestesia Epidural , Hipospadia , Bloqueio Nervoso , Humanos , Hipospadia/cirurgia , Masculino
18.
Front Pediatr ; 8: 353, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32714886

RESUMO

Background: Previous scoring systems have used renal scan parameters to assess severity of ureteropelvic junction obstruction-like hydronephrosis (UPJO-like HN), however this information is not always reliable due to protocol variation across centers and renogram limitations. Therefore, we sought to evaluate the Pyeloplasty Prediction Score (PPS), which utilizes only baseline ultrasound measurements to predict the likelihood of pyeloplasty in infants with UPJO-like. Methods: PPS was developed using three ultrasound parameters, Society of Fetal Urology (SFU) grade, transverse anteroposterior (APD), and the absolute percentage difference of ipsilateral and contralateral renal lengths at baseline. PPS was evaluated using prospectively collected prenatal hydronephrosis data (n = 928) of patients with UPJO-HN. Children with vesicoureteral reflux. primary megaureter, other associated anomalies, bilateral HN and <3 months of follow-up were excluded. Scores were analyzed regarding its usefulness in predicting which patients would be more likely to undergo pyeloplasty. Sensitivity, specificity, likelihood ratios (LR) and receiver operating characteristic (ROC) curve were determined. Results: Of 353 patients, 275 (78%) were male, 268 (76%) had left UPJO-like HN, and 81 (23%) had a pyeloplasty. The median age at baseline was 3 months (IQR 1-5). The PPS system was highly accurate in distinguishing patients who underwent pyeloplasty using baseline ultrasound measurements (AUC: 0.902). PPS of 7 and 8 were found to have a sensitivity of 85 and 78%, and specificity of 81 and 90%, respectively. PPS of 8 was associated with a LR of 7.8, indicating that these patients were eight times more likely to undergo pyeloplasty. Conclusion: Overall, PPS could detect patients more likely to undergo pyeloplasty using baseline ultrasound measurements. Those with a PPS of eight or higher were eight times more likely to undergo pyeloplasty.

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