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Penson DF, Krishnaswami S, Jules A, et al. Evaluation and Treatment of Cryptorchidism [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Dec. (Comparative Effectiveness Reviews, No. 88.)

Cover of Evaluation and Treatment of Cryptorchidism

Evaluation and Treatment of Cryptorchidism [Internet].

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Appendix FApplicability

Table F-1Applicability for Key Question 1a

DomainDescription of applicability of evidence compared to question
PopulationThe study populations were pre-pubescent boys with non-palpable undescended testes. The enrollment selection criteria and participant characteristics were not always explicitly detailed. Participants were excluded if they refused imaging or surgery and inappropriate exclusions were avoided.
InterventionStudies used ultrasound with varying frequency ranging between 3.5–12 MHz for imaging. CT scan and various magnetic resonance imaging techniques including conventional MRI, diffusion weighted MRI, MRA, MRV either alone or in combination were also employed. Imaging results were most always interpreted without the knowledge of the surgical results
ComparatorsThe comparators include open or laparoscopic surgical results
OutcomesThe outcomes were pre-operative identification and location of presence or absence of non-palpable undescended testes by imaging along with their concordance with surgical results. The assessments of outcomes were by radiologists or specialists and surgeons.
SettingOnly four of 18 studies were conducted in the U.S while half of the studies were conducted in Asia. Use of different types of scanners with different levels of operator experience along with lack of information on participants’ physical examination make comparisons of standard care difficult.

Table F-2Applicability for Key Question 1b

DomainDescription of applicability of evidence compared to question
PopulationThe study population primarily consisted of children with bilateral non-palpable cryptorchidism. One of the studies also included children with unilateral non-palpable cryptorchidism but the results were reported separately which allowed easy identification of the applicable results.
InterventionBoth studies used three daily injections of hCG to stimulate testosterone production although varying doses were used. Serum testosterone levels were measured by standard radioimmunoassays which are commonly available
ComparatorsNot applicable.
OutcomesAll studies confirmed the presence or absence by surgical exploration, which would be considered the gold standard for diagnosing anorchia in cryptorchidism.
SettingBoth studies were performed in Europe. However, there are minimal differences in the standard of care in this setting between Europe and the U.S. It is assumed that the initial hCG stimulation test was performed in the outpatient setting although this is not specifically mentioned.

Table F-3Applicability for Key Question 2

DomainDescription of applicability of evidence compared to question
PopulationThe study populations include children with both bilateral and unilateral cryptorchidism of varying ages. The study populations included the entire gamut of possible locations of the cryptorchid testicle, ranging from very low-lying testis in the high scrotum to nonpalpable abdominal testes and all locations in between. Most but not all of the studies made an effort to explicitly exclude children with retractile testes.
InterventionVarying hormonal agents were used alone and in combination, including hCG, LHRH (and its analogues) and hMG. Differing doses were used across the study in addition to differing dosing schedules. Most of the agents studied are available in the United States and represent the most commonly used hormones in this setting although some of the doses studied may not reflect standard practice in the U.S.
ComparatorsThe comparators include placebo (in matched dosing schedules) and various hormonal agents alone and in combination. These comparators are commonly used in practice, although some of the doses studied may not be consistent with standard of care in the U.S.
OutcomesThe most common outcome assessed was successful testicular descent into the scrotum. This was commonly assessed by the study or clinic staff as opposed to seeking the opinion of the affected child’s parent, whose opinion might differ with the clinician. Most but not all of the studies had adequate follow-up to assess for late recurrence/re-ascent of the testicle. Side-effects of hormonal therapy were infrequently described. Semen analysis in adulthood was asses in some studies as a proxy for fertility which is fairly widely accepted.
SettingThe majority of studies were performed in Europe where use of hormonal therapy in the treatment of cryptorchidism is presumably more common. The results of these studies, however, are still applicable to the U.S.

Table F-4Applicability for Key Question 3

DomainDescription of applicability of evidence compared to question
PopulationThe study populations include children of varying ages with both unilateral and bilateral cryptorchidism. Like Key Question 2, The study populations included the entire gamut of possible locations of the cryptorchid testicle, ranging from very low-lying testis in the high scrotum to nonpalpable abdominal testes and all locations in between.
InterventionThe surgical interventions studied included open and laparoscopic approaches to the diagnosis and treatment of cryptorchidism. The surgical techniques studied include open and laparoscopic abdominal exploration for the localization of the cryptorchid testicle; laparoscopic and open primary orchiopexy, one-stage and two-stage Fowler-Stevens orchiopexy and; various minor modifications of open orchiopexy. While a number of the minor modifications studied are not commonly employed in the U.S. today, the most common surgical techniques (primary orchiopexy and one- and two-stage Fowler-Stevens orchiopexy) are included using both open and laparoscopic approaches.
ComparatorsComparators included the same approaches mentioned in the intervention section above.
OutcomesThe most common outcomes assessed were appropriate testicular position into the scrotum and testicular atrophy. These were commonly assessed by the study or clinic staff as opposed to seeking the opinion of the affected child’s parent, whose opinion might differ with the clinician. Most but not all of the studies had adequate follow-up to assess for late recurrence of atrophy. Long-term fertility outcomes were also assessed in some studies using either semen analysis or actual paternity rates.
SettingSeven of the studies were performed in the U.S. while six were performed in Europe and eight in other countries. While the standard of care is similar between the U.S. and Europe, it is difficult to determine if the studies from the other countries truly reflect the U.S. standard of care.
Bookshelf ID: NBK115836
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