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Discordancy in Rates of Hypospadias Complications Reported to U.S. News & World Report: Need for an Audit?

By: Hans G. Pohl, MD | Posted on: 01 Jan 2022

The goals of hypospadias repair largely reflect the perspective of the individual assessing the procedure’s outcome, whether patient, parent, surgeon, or even third-party observer. These goals include creating an orthotopically placed meatus which provides a normal caliber urinary stream that can be directed while standing, a cosmetically pleasing (circumcised) appearance, the absence of curvature which precludes intercourse, normal sensation, and the absence of voiding symptoms, with the fewest number of procedures performed. The need to perform secondary procedures to correct a meatus not completely at the tip of the glans, glans dehiscence, urethrocutaneous fistula (UF), diverticula, urethral strictures, meatal stenosis, residual chordee or even the presence of redundant penile skin deflates any exuberance over an initially successful repair. For more proximal hypospadias which carries a greater risk for complications, function is the primary goal while appearance predominates for those with milder phenotypes. Complications for distal repair have been reported to be as low as 5%–10%, but as high as 12%–23% following proximal repairs.1–4 Over 200 variations of the repair have been described, all with the intent of improving outcomes.

Outcome reporting has moved beyond the province of academia as the public, payers and government regulatory agencies hold surgeons accountable for outcomes. For instance, U.S. News & World Report (USNWR) has established metrics against which quality is assessed, with hospitals receiving an overall grade based on a weighted scoring system that includes a measure of the rate of revision surgery for hypospadias. Thus, pediatric urology programs achieve for their institutions 0, 1, 2, or 3 points should their complication rates for distal hypospadias meet >5%, 3%–5%, between 1% and 3%, and <1%, respectively, and for proximal hypospadias meet >15%, 10%–15%, between 5% and 10%, and <5%, respectively.

However, data from individual institutions are discordant with the expectations held by USNWR methodology. Four major centers that followed their patients for approximately 36 months individually reported complications for proximal hypospadias repairs in 38.3% to 62% of cases, depending on whether 1-stage or 2-stage repairs were used.5–8 These 4 institutions are not unique. A systematic review and meta-analysis compared outcomes of proximal hypospadias repair by single stage foreskin pedicle tube, 2-stage foreskin free graft or 2-stage foreskin pedicled flap over the preceding decade from 2010 to 2020.9 Rates of UF, glans dehiscence, urethral strictures, meatal stenosis, diverticula, recurrent or residual chordee, buried penis and poor cosmesis were sought. Of 2,664 patients, 680 (25%) underwent single-stage repair and 1,984 (75%) underwent a 2-stage repair; the mean followup for all was 4.5 years (1.8–14 years). Patients who underwent a single-stage repair (foreskin pedicle tube) had a statistically significant higher rate of complications than those who underwent a 2-stage repair (285/680 [42%] and 414/1,984 [21%], respectively, p=0.001). While similar overall complication rates were found between the 2-stage techniques (foreskin free graft, 155/674 [23%] and foreskin pedicled flap, 259/1,310 [20%], p=0.1), foreskin free graft had fewer rates of UF, meatal stenosis, glans dehiscence and diverticula than foreskin pedicle tube.

“Data from individual institutions are discordant with the expectations held by USNWR methodology.”

Recently, literature seeking to reconcile the discordance in reported rates of hypospadias and expected rates established by USNWR and which some institutions are meeting has been published. We examined cases in the Pediatric Health Information System (PHIS) database to assess the comparable rates for revisions following distal and proximal hypospadias across the 45 not-for-profit freestanding pediatric hospitals affiliated with the Children’s Hospital Association.10,11

“Broadening the list of revision procedure codes identified more patients who underwent revision surgery, indicating a selection bias using USNWR’s methodology.”

Twenty-nine hospitals met inclusion criteria, providing information on 19,931 patients undergoing distal hypospadias repairs (median hospital level followup, 4.16 years; hospital level range 3.46–5.33 years) and 5,840 patients undergoing proximal hypospadias repairs (median hospital level followup, 3.83 years; range 2.25–5.25 years). We observed that the number of index cases at each institution over a 5-year period remained relatively constant overall, with few exceptions. The average rate (sum of 29 mean rates/29 hospitals) was 3.32% (range: 0.48%–7.36%) and 12.29% (range: 3.48%–36.36%) for distal and proximal hypospadias repairs, respectively. For any individual hospital, revision rates changed from year to year, in some cases sufficiently to change the number of points received from USNWR despite no substantive differences in the composition of the program. We also noted that broadening the list of revision procedure codes identified more patients who underwent revision surgery, indicating a selection bias using USNWR’s methodology (fig. 1). Revision rates also increased for all degrees of hypospadias when followup time was extended beyond 2 calendar years as well as when adjusting for lead-time bias which does not occur as part of the USNWR methodology (figs. 2 and 3).

Figure 1. Median revision rates following distal and proximal hypospadias procedures in 29 hospitals. To evaluate appropriateness of USNWR code list to identify revisions, 3 CPT groups were defined. Group A included codes sought by USNWR. Group B was Group A plus codes for acquired UF in males. Group C was Group B plus any revision codes associated with index procedures.
Figure 2. Revision rates following increasing followup after distal and proximal hypospadias repairs. To evaluate appropriateness of USNWR followup interval, we assessed revision rates with ever-increasing followup intervals up to 7 years.
Figure 3. Revision rates for 19,931 distal and 5,840 proximal hypospadias repairs, normalized to length of individual followup for each case. Yearly revision rates were summarized by median and quantile to correlate whether median revision rates changed significantly whether enhanced code lists or increased followup were used.

Aside from lead-time bias and classification bias, limited sample sizes also affect USNWR methods. Baker and colleagues found that 10.9% of hospitals did not have adequate distal hypospadias volume to achieve full points even when reporting no revisions, and the rate of misclassification exceeded 50% in hospitals reporting distal hypospadias complications.12

Perhaps the most sobering outcomes data come from the groups at Ghent University Hospital and Medical University of Austria, published in the September 2021 issue of The Journal of Urology®.13 A case-control study of 193 patients (median age 18.1 years) with all degrees of hypospadias (mean followup, 16.4 years; range, 8.2–21.2 years) were compared to 50 unaffected males (median age 19.6 years). One or multiple revision surgeries were performed in 39.2% of all cases, sometimes up to a decade later. Overall, 52.9% of patients had an unsatisfactory urinary and/or sexual outcome as UF occurred in 5.7%, residual hypospadias in 24.9%, suboptimal voiding by uroflowmetry in 22.1% and sexual dysfunction in 20.3% (as compared with 6% of controls). However, the authors optimistically report the lack of agreement between physicians and patients regarding cosmetic outcomes, the patients being more satisfied than the physicians, and suggest that substantive revisions be deferred until patients are old enough to weigh in on what matters.

While the “pursuit of the perfect penis” is a laudable goal, we should remain circumspect about how that goal is defined.14 Quality is more than the sum of a short list of metrics and the methods used to assess quality require “careful attention to statistical principles, [lest] we run the risk of doing a disservice to our patients and our profession by misrepresenting differences between hospitals.”12

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