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Item A multi-site pilot study of a parent-centered tool to promote shared decision-making in hypospadias care(Elsevier, 2023) Binion, Kelsey E.; Rode, Akash Uday; Nortey, Gabrielle; Miller, Andrew D.; Misseri, Rosalia; Kaefer, Martin; Ross, Sherry; Preisser, John S.; Hu, Di; Chan, Katherine H.; Communication Studies, School of Liberal ArtsBackground: Using a user-centered design approach, we conducted a two-site pilot study to evaluate a decision aid (DA) website, the Hypospadias Hub, for parents of hypospadias patients. Objectives: The objectives were to assess the Hub's acceptability, remote usability, and feasibility of study procedures, and to evaluate its preliminary efficacy. Methods: From June 2021-February 2022, we recruited English-speaking parents (≥18 years old) of hypospadias patients (≤5 years) and delivered the Hub electronically ≤2 months before their hypospadias consultation. We collected website analytic data using an ad tracker plug-in. We inquired about treatment preference, hypospadias knowledge, and decisional conflict (Decisional Conflict Scale) at baseline, after viewing the Hub (pre-consultation), and post-consultation. We administered the Decision Aid Acceptability Questionnaire (DAAQ) and the Preparation for Decision-Making Scale (PrepDM) which assessed how well the Hub prepared parents for decision-making with the urologist. Post-consultation, we assessed participants' perception of involvement in decision-making with the Shared Decision-making Questionnaire (SDM-Q-9) and the Decision Regret Scale (DRS). A bivariate analysis compared participants' baseline and pre/post-consultation hypospadias knowledge, decisional conflict, and treatment preference. Using a thematic analysis, we analyzed our semi-structured interviews to uncover how the Hub impacted the consultation and what influenced participants' decisions. Results: Of 148 parents contacted, 134 were eligible and 65/134 (48.5%) enrolled: mean age 29.2, 96.9% female, 76.6% White (Extended Summary Figure). Pre/post-viewing the Hub, there was a statistically significant increase in hypospadias knowledge (54.3 vs. 75.6, p < 0.001) and decrease in decisional conflict (36.0 vs. 21.9, p < 0.001). Most participants (83.3%) thought Hub's length and amount of information (70.4%) was "about right", and 93.0% found most or everything was clear. Pre/post-consultation, there was a statistically significant decrease in decisional conflict (21.9 vs. 8.8, p < 0.001). PrepDM's mean score was 82.6/100 (SD = 14.1); SDM-Q-9's mean score was 82.5/100 (SD = 16.7). DCS's mean score was 25.0/100 (SD = 47.03). Each participant spent an average of 25.75 min reviewing the Hub. Based on thematic analysis, the Hub helped participants feel prepared for the consultation. Discussion: Participants engaged extensively with the Hub and demonstrated improved hypospadias knowledge and decision quality. They felt prepared for the consultation and perceived a high degree of involvement in decision-making. Conclusion: As the first pilot test of a pediatric urology DA, the Hub was acceptable and study procedures were feasible. We plan to conduct a randomized controlled trial of the Hub versus usual care to test its efficacy to improve the quality of shared decision-making and reduce long-term decisional regret.Item The ability of a limited metabolic assessment to identify pediatric stone formers with metabolic abnormalities(Elsevier, 2018) Chan, Katherine H.; Moser, Elizabeth A.; Whittam, Benjamin M.; Misseri, Rosalia; Cain, Mark P.; Krambeck, Amy; Urology, School of MedicineIntroduction American Urological Association guidelines recommend a urinary metabolic evaluation after the first stone event in all pediatric stone patients. Prior studies identified hypercalciuria and urine hypovolemia as the most common abnormalities in children with urolithiasis. Recent data suggest that hypocitraturia is most prevalent. It was hypothesized that a limited evaluation would detect the majority of clinically significant metabolic abnormalities in pediatric stone formers. Material and methods A retrospective analysis of all children (<18 years of age) with renal/ureteral calculi evaluated at the study institution from 2005 to 2015 was performed. Children with ≥ one 24-h urinary metabolic profile after a clinical visit for renal/ureteral calculi were included. Those with bladder stones and those with undercollection or overcollection or missing urinary creatinine were excluded. Demographics and data from the first urinary metabolic profile and stone analyses were collected. The sensitivity, specificity, and positive and negative predictive value (NPV) of a limited urinary metabolic evaluation consisting of four parameters (24-h calcium, citrate, and oxalate and low urinary volume) were compared to a complete urinary metabolic profile. The number and type of metabolic abnormalities that would have been missed with this limited evaluation weredetermined. Results Of 410 patients, 21 were excluded for age ≥18 years, 13 for bladder stones, 248 for overcollections, 38 for undercollections, and 10 for missing creatinine. This left 80 patients for inclusion: median age 11.4 years, 60% female, and 96.3% white. Of the entire cohort, 69.6% had hypocitraturia, 52.5% had low urine volume, and 22.5% had hypercalciuria. Sensitivity was 87.5%. Specificity could not be calculated because no patients had a normal complete metabolic evaluation. The NPV was zero, and the positive predictive value was 100%, but these are artifacts resulting from the absence of patients with a normal complete metabolic evaluation. Of the 80 patients, 10 had at least one abnormality missed by a limited metabolic evaluation (Table 1). The missed abnormalities were high pH (n = 6), abnormal 24-h phosphorus (low in 1 patient and high in 1 patient), low 24-h magnesium (n = 3), low 24-h potassium (n = 3), and high 24-h sodium (n = 4). Discussion A limited urinary metabolic evaluation would have detected the vast majority of clinically significant metabolic abnormalities in the study sample. Approximately two-thirds of the study patients submitted inadequate 24-h urine specimens. Conclusions A simplified approach to metabolic evaluation in first-time stone formers with a stone analysis available was proposed. This streamlined approach could simplify the metabolic evaluation and reduce health care costs.Item Ask the parents: Testing the acceptability and usability of a hypospadias decision aid(Elsevier, 2022) Binion, Kelsey; Miller, Andrew; Misseri, Rosalia; Kaefer, Martin; Longtin, Krista; Carroll, Aaron; Wiehe, Sarah E.; Chan, Katherine H.; Communication Studies, School of Liberal ArtsIntroduction: In previous work, we engaged key stakeholders to create a web-based decision aid (DA) prototype to facilitate shared decision making about hypospadias. Objective: The study's objective was to use a human-centered design approach to assess the DA's acceptability and usability and revise it prior to pilot testing. Methods: We recruited English-speaking parents (≥18 years old) of sons with hypospadias (≤5 years) for a two-phase process of semi-structured phone/video interviews to obtain feedback about our DA prototype. DA webpages included: "Hypospadias," "Surgery Basics," "No Surgery," "Family Stories," "Help Me Decide," and "FAQs." In both phases, participants viewed the DA using the "think aloud" technique and completed several validated scales to evaluate its acceptability and usability. In phase 1, we collected feedback about the "Homepage" organization, values clarification methods (VCM), and webpage content. In phase 2, participants searched the DA for answers to hypospadias-related questions, provided feedback on testimonial videos and VCM, and shared their preferences about data visualizations. All interviews were audio recorded. After each phase, transcripts were qualitatively analyzed to identify key areas for revision. Revisions were made between phase 1 and 2 to improve the DA's acceptability and usability. Results: We interviewed 20 participants (10/phase): median age 33.7 years, 60% female, 80% White. Mean score on the Preparation for Decision Making Scale: 86.8 (out of 100). We revised: 1) VCM, focusing on pros/cons of surgery and question prompts, 2) "Homepage," adding webpage descriptions (Extended Summary Figure), 3) menu organization, 4) "Surgery Day" webpage, adding general anesthesia risk information, and 5) "Hypospadias" webpage, adding an icon bar graph to help participants visualize statistics. Participants thought the testimonial videos were relatable and the VCMs would prepare them for their visit with their child's urologist. Discussion: Ours is the first parent-centered DA developed and pre-tested for hypospadias. Using validated usability and acceptability scales, participants highly rated the DA in helping them arrive at a decision about surgery. Study limitations include the sample's lack of diversity (i.e., educated, health literate) and participants already decided about their son's hypospadias management before enrolling. To learn more about the DA's usability and acceptability, we plan to pilot test it in a clinical setting. Conclusions: Participants found our DA informative in understanding hypospadias. There was a high perceived level of preparation for hypospadias decision making. Participatory research methods, such as "think aloud," may be helpful when testing DAs as they privilege the patient's experience.Item Community Engagement of Adolescents in the Development of a Patient-Centered Outcomes Tool for Adolescents with a History of Hypospadias Repair(Elsevier, 2019) Chan, Katherine H.; Panoch, Janet; Carroll, Aaron; Downs, Stephen; Cain, Mark P.; Frankel, Richard; Cockrum, Brandon; Moore, Courtney; Wiehe, Sarah; Pediatrics, School of MedicineIntroduction Hypospadias may lead to long-term issues with urination, sexual function and psychosocial well-being. Limited evidence exists regarding the healthcare communication preferences of male adolescents regarding sensitive topics. Objective The purpose of this qualitative study was to explore the healthcare communication preferences of male adolescents regarding sensitive topics (e.g. urinary and sexual issues) and engage them in in the initial stages of development a patient-centered outcomes tool for adolescents with a history of hypospadias repair. Study Design A multi-disciplinary team with communication design expertise, pediatric urology experts, and health services researchers developed a self-reported toolkit for adolescent patients who had hypospadias repair as children. The toolkit featured short writing/diagramming exercises and scales to facilitate participant reflections about genital appearance, urination, sexual function and psychosocial well-being. We recruited students from two local high schools for two focus groups to obtain feedback about the usability/acceptability of the toolkit’s appearance/content. We inquired about language preferences and preferred format and/or setting for sharing sensitive information with researchers. The focus groups were audio recorded, professionally transcribed, checked for accuracy and analyzed by two coders using qualitative content analysis. Major themes and subthemes were identified and representative quotes were selected. Results We conducted two focus groups in January 2018 with 33 participants, ages 14-18. Participants preferred language that would make patients feel comfortable as well as serious, clinical language rather than slang terms/sexual humor (Extended Summary Table). They recommended avoidance of statements implying that something is wrong with a patient or statements that would pressure the patient into providing answers. They suggested fill-in-the-blank and open-ended responses to encourage freedom of expression and colorful graphics to de-emphasize the test-like appearance of the toolkit. Most participants preferred a toolkit format to a one-on-one interview to discuss sensitive topics such as urinary or sexual issues. Participants would prefer either a male interviewer or would like to have a choice of interviewer gender for individual qualitative interviews, and they recommended a focus group leader with a history of hypospadias repair. Discussion This study provides a rich description of a group of male high school students’ experiences with healthcare providers and researchers. Its qualitative design limits generalizability and our findings may not be similar to adolescents with a history of hypospadias repair. Conclusion We used focus group feedback on the toolkit prototype to refine the tool for use in a future study of adolescents with history of hypospadias repair.Item Comparison of Intraoperative and Early Postoperative Outcomes of Caudal Versus Dorsal Penile Nerve Blocks for Outpatient Penile Surgeries(Elsevier, 2017) Chan, Katherine H.; Shah, Aali; Moser, Elizabeth A.; Szymanski, Konrad; Whittam, Benjamin M.; Misseri, Rosalia; Kaefer, Martin; Rink, Richard; Cain, Mark P.; Urology, School of MedicineObjective To compare intraoperative and 1-hour postoperative outcomes in caudal versus dorsal penile nerve block (DPNB) patients undergoing penile surgeries. Material and Methods We performed a retrospective cohort study of males <10 years old undergoing penile procedures (2013-2015) using the Pediatric Regional Anesthesia Network, Pediatric Health Information System databases and our medical records. The primary outcome was a maximum Faces Limbs Activity Crying Consolability pain score > 3. Secondary outcomes were intraoperative/post-anesthesia care unit (PACU) narcotics, pre-incision anesthesia time, adjusted operating room charges and complications. We performed bivariate and multivariable analyses controlling for demographic/procedure characteristics and clustering by surgeon. Results Of 738 patients, (mean age 2.1 years) 74.1% had a caudal. DPNB patients were more likely to have a maximum pain score >3 (19.5% vs. 8.1%, p<0.0001), receive intraoperative (33.0% vs.2.9%, p<0.0001) and PACU narcotics (15.7% vs. 7.5% vs. p=0.0009), had shorter pre-incision anesthesia time (19.5 vs. 27.9 minutes, p<0.0001) and lower adjusted operating room charges ($9,402 vs. $12,760, p<0.0001). In a bivariate logistic regression, DPNB patients had 2.7 times the odds of a maximum pain score > 3 (95% CI 1.7- 4.4, p<0.0001) and 5.2 times the odds of intraoperative/PACU narcotic administration (95% CI 3.3-8.1, p<0.0001). In multivariable analyses, caudal patients had longer pre-incision anesthesia time (27.9 ± 7.4 vs. 19.5 ± 6.6 minutes, p<0.0001) and higher adjusted operating room charges ($12,760 ± 4077 vs. $9,402 ± 3741, p=0.01). Conclusion Caudal blocks may offer a small advantage in the immediate postoperative period although cost-effectiveness is unproven.Item Consulting “Dr. YouTube”: an objective evaluation of hypospadias videos on a popular video-sharing website(Elsevier, 2020-02-16) Salama, Amr; Panoch, Janet; Bandali, Elhaam; Carroll, Aaron; Wiehe, Sarah; Downs, Stephen; Cain, Mark P.; Frankel, Richard; Chan, Katherine H.; Urology, School of MedicineIntroduction: Parents who make decisions about hypospadias repair for their child may seek information from online platforms such as YouTube. Objective: The purpose of this study is to evaluate the health literacy demand of hypospadias videos on YouTube using the Patient Education Materials Assessment Tool for Audiovisual Materials (PEMAT-A/V). Study design: We performed a YouTube search using the term "hypospadias," limiting results to the first 100 videos. We excluded videos that were <1 min or >20 min and videos that were not in English or did not include subtitles. Two evaluators independently examined videos and determined PEMAT-A/V scores for understandability and actionability (i.e., ability to identify actions the viewer can take). Videos with scores >70% are understandable or actionable. The inter-rater reliability (kappa) and intraclass correlation coefficient (ICC) of PEMAT scores were calculated. Bivariate and multivariable linear regression models assessed the association of video characteristics with respective scores. Results: Of the 100 videos that were identified on YouTube, 47 (47%) were excluded leaving 53 for analysis: 14 were >20 min, 14 were <1 min, 9 had no audio or subtitles, 7 were not in English, 1 was a duplicate, 1 was unrelated to hypospadias, and 1 was deleted at the time of data analysis. Three (5.6%) were understandable (mean score 54.5%, standard deviation (SD) 14.9) and eight (15.1%) were actionable (mean score 21.8%, SD 16.6) (Extended Summary Figure). Kappa values ranged from 0.4 to 1. The ICC's were 0.55 and 0.33 for understandability and actionability, respectively. In the bivariate analysis, mean understandability scores were significantly higher for English language videos (p = 0.04), videos with animation (p = 0.002), and those produced by industry (p = 0.02). In the multivariable analysis, mean understandability scores were significantly higher for "expert testimonial" or "other" video types after adjusting for graphics type and overall tone (p = 0.04). Mean understandability scores were also significantly higher for videos with animation after adjusting for video type and overall tone (p = 0.01). Mean actionability scores were significantly higher for videos with a negative tone (p = 0.01). Discussion: The vast majority of hypospadias-related YouTube content is not appropriate for users with low health literacy although certain types of videos, such those with animation and expert testimonials, scored higher on understandability than other types. Conclusion: Due to the lack of sufficient online informational content regarding hypospadias, we plan to engage parents of sons with hypospadias in the development of high-quality patient educational materials about hypospadias.Item Cost-effectiveness analysis of the management of distal ureteral stones in children(Elsevier, 2019) Chan, Katherine H.; Whittam, Benjamin M.; Krambeck, Amy; Downs, Stephen M.; Misseri, Rosalia; Cain, Mark P.; Bennett, William E., Jr.; Urology, School of MedicineObjective To determine the most cost-effective approach to the management of distal ureteral stones in children given the potential for recurrent renal colic during a trial of passage versus potential stent discomfort and complications of ureteroscopy. Methods We developed a decision tree to project costs and clinical outcomes associated with observation, medical explusive therapy (MET), and ureteroscopy for the management of an index patient with a 4mm distal ureteral stone. We determined which strategy would be least costly and offer the most pain-free days within 30 days of diagnosis. We performed a one-way sensitivity analysis on the probability of successful stone passage with MET. We obtained probabilities from the literature and costs from the 2016 Pediatric Health Information System Database. Results Ureteroscopywas the costliest strategy but maximized the number of pain-free days within 30 days of diagnosis ($5,282/29 pain-free days). MET was less costly than ureteroscopybut also less effective ($615/21.8 pain-free days). Observation cost more than MET and was also less effective ($2,139/15.5 pain-free days). The one-way sensitivity analysis on the probability of successful stone passage with MET demonstrated that ureteroscopyalways has the highest net monetary benefits value and is therefore the recommended strategy given a fixed WTP. Discussion Using a rigorous decision-science approach, we found that ureteroscopy is the recommended strategy in children with small distal ureteral stones. Although it cost more than MET, it resulted in more pain-free days in the first 30 days following diagnosis given the faster resolution of the stone episode.Item Initial collection of an inadequate 24-hour urine sample in children does not predict subsequent inadequate collections(Elsevier, 2018) Chan, Katherine H.; Moser, Elizabeth A.; Whittam, Benjamin M.; Misseri, Rosalia; Cain, Mark P.; Krambeck, Amy; Schwaderer, Andrew; Urology, School of MedicineIntroduction Approximately half of adult stone formers submit specimens that are either under or over collections as determined by 24-h creatinine/kg. Previously identified predictors of inadequate collection in adults include female sex, older age, higher body mass index (BMI), vitamin D supplementation, and weekday collection. Objective The objective of this study is to determine risk factors for inadequate 24-h urinary specimen collection in the pediatric population. Study design A retrospective analysis of all children (<18 years of age) with renal and/or ureteral calculi evaluated at the study tertiary care pediatric center from 2005 to 2015 was performed. Those who had at least one 24-h urinary metabolic profile after a clinical visit for kidney and/or ureteral stones were included; children with bladder stones were excluded. Adequate collections had a urine creatinine of 10–15 mg/kg/24 h. A bivariate analysis of potential factors associated with inadequate collection of the initial urinary metabolic profile, including child demographics, parental socio-economic factors, history of stone surgery, and weekday vs. weekend urine collection, was performed. A mixed-effects logistic regression, controlling for correlation of specimens from the same patient, was also performed to determine whether an initial inadequate collection predicted a subsequent inadequate collection. Results Of 367 patients, 80 had an adequate collection (21.9%): median age, 13 years (interquartile range, 8–16); 61.1% female; 93.5% white; 19.5% obese; and 13.0% overweight. No parental or child factors were associated with inadequate collection (Summary Table). Of inadequate collections, more than 80% were over collections. In the 175 patients with more than one 24-h urinary specimen collection, the effect of an initial inadequate collection on subsequent inadequate collections was not significant after controlling for the correlation of samples from the same patient (p = 0.8). Discussion Any parental or child factors associated with the collection of inadequate 24-h urine specimens in children were not found. An initial inadequate collection does not predict subsequent inadequate collections. It was surprising that >80% of the inadequate collections were over collections rather than under collections. Possible explanations are that children collected urine samples for longer than the 24-h period or that stone-forming children produce more creatinine per 24-h period than healthy children due to hyperfiltration. Conclusion Inadequate collections are very common, and the risk factors for them are unclear. A repeat collection would be suggested if the first is inadequate. Further studies must be planned to explore barriers to accurate specimen collection using qualitative research methodology.Item Is surgical antibiotic prophylaxis necessary for pediatric orchiopexy?(Elsevier, 2018) Rensing, Adam J.; Whittam, Benjamin M.; Chan, Katherine H.; Cain, Mark P.; Carroll, Aaron E.; Bennett, William E., Jr.; Urology, School of MedicineIntroduction Surgeons frequently use surgical antibiotic prophylaxis (SAP), despite limited evidence to support its efficacy. Potential adverse events associated with antibiotic use include allergic reaction (including anaphylaxis), Clostridium difficile infection, and selecting for resistant bacteria. Surgical site infections (SSI) are very rare in patients undergoing clean pediatric urologic procedures. Current guidelines are unclear about the efficacy of surgical antibiotic prophylaxis for prevention of SSI in the pediatric population. Objective It was hypothesized that children who received SAP prior to orchiopexy would have no reduction in surgical site infection (SSI) risk but an increased risk of antibiotic-associated adverse events. Methods A retrospective cohort study was conducted of all males aged between 30 days and 18 years who underwent an orchiopexy (ICD-9 CM 62.5) in an ambulatory or observation setting from 2004 to 2015 using the Pediatric Health Information System database. Inpatients and those with concomitant procedures were excluded. Chi-squared or Fisher's exact tests were used to determine the association between SAP and allergic reaction (defined as a charge for epinephrine or ICD-9 diagnosis code for allergic reaction on the date of surgery) and any of the following within 30 days: SSI, hospital readmission or any repeat hospital encounter. Mixed effects logistic regression was performed, controlling for age, race, and insurance, and clustering of similar practice patterns by hospital. Results A total of 71,767 patients were included: median age was 4.6 years, 61.4% were white, and 49.3% had public insurance; 33.5% received SAP. Of these participants, 996/71,767 (1.4%) had a perioperative allergic reaction and <0.1% were diagnosed with an SSI. On mixed effects logistic regression, those who received SAP had 1.2 times the odds of a perioperative allergic reaction compared with those who did not receive SAP ( P = 0.005). Surgical antibiotic prophylaxis was not associated with decreased rates of SSI, lower hospital readmission, nor a lower chance of a repeat encounter within 30 days. Conclusions In patients undergoing orchiopexy, it was found that SAP did not reduce the risk of postoperative SSI, readmissions, or hospital visits. Patients who received SAP had significantly increased odds of perioperative allergic reaction. This demonstrated that the risks of SAP outweigh the benefits in children undergoing orchiopexy.Item Parental Perspectives on Decision-making about Hypospadias Surgery(Elsevier, 2019) Chan, Katherine H.; Panoch, Janet; Carroll, Aaron; Wiehe, Sarah; Downs, Stephen; Cain, Mark P.; Frankel, Richard; Medicine, School of MedicineIntroduction Many parents who choose hypospadias repair for their son experience decisional conflict and regret. The utilization of a shared decision-making process may address the issue of decisional conflict and regret in hypospadias repair by engaging both parents and physicians in decision-making. Objective The objective of this study was to develop a theoretical framework of the parental decision-making process about hypospadias surgery to inform the development of a decision aid. Study Design We conducted semi-structured interviews with parents of children with hypospadias to explore their role as proxy-decision-makers, inquiring about their emotions/concerns, informational needs and external/internal influences. We conducted interviews until no new themes were identified, analyzing them iteratively using open, axial and selective coding. The iterative approach entails a cyclical process of conducting interviews and analyzing transcripts while the data collection process is ongoing. This allows the researcher to make adjustments to the interview guide as necessary based on preliminary data analysis in order to explore themes that emerge from early interviews with parents. We used grounded theory methods to develop an explanation of the surgical decision-making process. Results We interviewed 16 mothers and 1 father of 7 preoperative and 9 postoperative patients (n=16) with distal (8) and proximal (8) meatal locations. We identified four stages of the surgical decision-making process: 1) processing the diagnosis, 2) synthesizing information, 3) processing emotions and concerns and 4) finalizing the decision (Extended Summary Figure). We identified core concepts in each stage of the decision-making process. Primary concerns included anxiety/fear about the child not waking up from anesthesia and their inability to be present in the operating room. Parents incorporated information from the Internet, medical providers and their social network as they sought to relieve confusion and anxiety while building trust/confidence in their child’s surgeon. Discussion The findings of this study contribute to our understanding of decision-making about hypospadias surgery as a complex and multi-faceted process. The overall small sample size is typical and expected for qualitative research studies. The primary limitation of the study, however, is the underrepresentation of fathers, minorities and same-sex couples. Conclusions This study provides an initial framework of the parental decision-making process for hypospadias surgery that will inform the development of a decision aid. In future stages of decision aid development, we will focus on recruitment of fathers, minorities and same-sex couples in order to enrich the perspectives of our work.