Scoping review: Reporting characteristics for the safety of contact lenses in the pediatric population.

SIGNIFICANCE: Contact lenses are an increasingly popular option for correcting pediatric refractive error due to increased awareness of interventions to slow myopia progression. With limited information on the safety profiles of contact lenses in children, it is important to characterize the current understanding and promote this device's safe and effective use. PURPOSE: This scoping review evaluates characteristics of the current literature that have examined the safety of contact lenses in pediatric patients. It provides future directions for systematic reviews and identifies any gaps in the current literature or areas for future research. METHODS: Literature searches in MEDLINE via PubMed, EMBASE, The Cochrane Library, trial registries, and U.S. Food and Drug Administration clinical trial documentation were performed. Included studies (i.e., experimental and quasi-experimental studies; observational studies including prospective and retrospective cohort, case-control, and analytical cross-sectional studies, and case series of 30 or more participants) reported safety and/or complications of the use of any contact lens for correcting refractive error in children (0 to 18 years). Two independent reviewers first screened the titles and abstracts, and then full-text reports for eligibility. Conflicts in eligibility were resolved by discussions with a third reviewer. Two independent reviewers extracted data, including details about the participants, context, study methods, and key findings relevant to the review question. RESULTS: This scoping review included 73 studies from 10 countries using different contact lens modalities, primarily orthokeratology and soft contact lenses, in children (6 to 18 years). The most common adverse event reported by the studies was corneal staining (60% orthokeratology, 45% soft contact lens). CONCLUSIONS: The need for uniform reporting standards for adverse events poses challenges for comprehensive data synthesis. However, this scoping review identified a sufficient number of studies for a future systematic review to quantify the risks associated with orthokeratology and soft contact lens use in children.

Defining Daily Disposable Contact Lens Wear in a Clinical Study.

SIGNIFICANCE: The U.S. Food and Drug Administration regulates contact lenses as prescription medical devices and defines daily disposable lenses for single use; however, safety comparisons between daily disposable and reusable lenses rely on the lens-wearing regimen. When inappropriately discerned, studies may erroneously report replacement regimen, resulting in inaccurate risk rates. PURPOSE: This study aimed to explore different measures for defining daily disposable wearers in the context of a clinical study. METHODS: A secondary analysis of data from five multisite fieldings (n = 1059) from the Contact Lens Risk Survey was performed. Descriptive statistics were used to examine self-reported lens replacement, use of lens case, and manufacturer's recommended replacement frequency as defined by the participants' selection of their habitual lenses using a photographic aide. Daily disposable wearers were identified as reporting daily replacement (by self-report and lens identification) and not using a lens case. If there was a discrepancy among these three factors, the lens assignment was assessed as a majority response (two of three) or as missing if conflicting information was reported. RESULTS: The cohort was approximately two-thirds (68.7%) female and ranged from 12 to 33 years of age. A total of 154 participants (14.5%) were classified as daily disposable wearers and 896 (84.6%) as reusable wearers. Congruence was observed among all three daily disposable assignment factors for only 106 wearers (68.8%). The greatest discrepancy among daily disposable wearers was the report of using a lens case (n = 32 [20.8%]). In contrast, reusable lens wearers were more likely to report agreement across all three factors (n = 798 [89.1%], P < .001). CONCLUSIONS: This analysis suggests that the report of not using a lens case is a more conservative surrogate for true single-use lens wear, as one in five may be storing and reusing their daily disposable lenses.

Examining daily disposable soft contact lens wearers' attitudes and beliefs using the Health Belief Model.

PURPOSE: To use the Health Belief Model (HBM) to understand daily disposable (DD) soft contact lens (SCL) wearers' attitudes and beliefs. METHODS: A convenience sample of DD SCL wearers (18-33 years) was enrolled at two sites. Participants were queried about demographics, SCL wear and HBM constructs. Rasch analysis was used to assess the psychometric properties of the survey instrument and generate scores for each HBM subscale. ANOVA was used to determine relationships among HBM constructs, subject demographics and DD SCL-related health behaviours. RESULTS: One hundred people participated (mean ± SD), age = 24.2 ± 3.9 years, 76% female. Thirty-seven percent reported sleeping in DD SCLs and 25% reported reusing DD SCLs. Self-report of reusing DD SCLs was associated with scores on the benefits: reuse (p = 0.02) and barriers (p = 0.007) subscales, and sleeping in lenses was associated with scores on the susceptibility (p = 0.05), benefits: wear behaviours (p = 0.006) and barriers (p = 0.01) subscales. Rasch analysis showed some subscales demonstrated multidimensionality. CONCLUSIONS: Selected health belief constructs were associated with DD SCL-related behaviours including reusing and overnight wear. Increased understanding of SCL attitudes and beliefs could inform patient education and interventions to decrease risks associated with improper SCL wear.

Change in Risk Score and Behaviors of Soft Contact Lens Wearers After Targeted Patient Education.

OBJECTIVES: To determine if targeted education can influence the behaviors and scores of soft contact lens (SCL) wearers via the Contact Lens Risk Survey (CLRS). METHODS: This was a multicenter, prospective, case-control study. Cases were symptomatic red eye SCL wearers (age, 18-39 years), and controls were age , sex, and site matched. Participants completed the CLRS and were provided targeted patient education at three time points: baseline, one, and six months. Change in scores and behaviors were analyzed using the Wilcoxon signed rank test. RESULTS: Forty-one cases and 71 controls were analyzed. The mean risk score (mean±SE) from baseline to follow-up improved (reduced) for all participants (-1.96±0.73; P =0.01), mostly driven by the improvement among cases (-2.55±1.32; P =0.05). Case subjects reported a decrease in frequency of wearing lenses while showering (-0.32±0.07; P <0.0001), discarding lens solution (-0.13±0.06; P =0.03), and rinsing lenses with tap water (-0.19±0.08; P =0.02) after targeted education. CONCLUSIONS: Targeted patient education can influence some behaviors of SCL wearers, especially those who experienced a red eye event. Further study is needed to determine how to improve other risk behaviors and whether these changes are sustained long term.

Gas-Permeable Contact Lenses and Water Exposure: Practices and Perceptions.

SIGNIFICANCE: This study provides insight into the current recommendations, clinical behaviors, and risk assessments of eye care professionals on the topic of rigid contact lens exposure to tap water. This knowledge may motivate professional organizations to develop initiatives to educate eye care professionals on the dangers of contact lens exposure to water. PURPOSE: The purpose of this study was to investigate the practice patterns and risk perceptions of eye care professionals regarding gas-permeable contact lens exposure to tap water. METHODS: A branched-logic survey was started by 320 clinicians, vision scientists, and industry personnel and was fully completed by 272 participants. The survey queried participants about their current practices, recommendations, and perceptions of risk regarding exposure of gas-permeable contact lenses to tap water. RESULTS: Of those who prescribe gas-permeable contact lenses, 57.4% reported rinsing lenses with tap water, whereas only 32.7% reported engaging in this same behavior in front of patients. Of those who reported never rinsing lenses with tap water, 85.6% indicated that rinsing lenses with water increases infection risk, whereas 52.1% of those who rinse lenses with water reported the same perceived risk (P < .001). Of all participants, 60% indicated that wearing contact lenses while showering increases infection risk, and 50.2% of all participants advised patients to avoid this behavior. CONCLUSIONS: A discrepancy exists between perceptions of risk concerning exposure of contact lenses to water and both clinical practices and patient education provided by professionals.

A Prospective Randomized Controlled Trial of Irrigation "Bag Squeeze" to Manage Pain for Patients Undergoing Flexible Cystoscopy.

PURPOSE: We determined if the "bag squeeze" technique decreases pain during flexible cystoscopy in men. MATERIALS AND METHODS: This single center, prospective, double-blind, randomized controlled trial recruited 200 consenting participants who were ambulatory, outpatient males who had undergone prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded from study. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the bag squeeze (group A) or the sham bag squeeze procedure (group B). Following cystoscopy, participants completed a pain questionnaire (visual analogue scale). Differences in mean pain score between groups were evaluated using Students' t-test with a 2-sided alpha of 0.05. RESULTS: A total of 200 patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients 97 were randomized to bag squeeze (group A) and 93 to sham bag squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively (p <0.005). CONCLUSIONS: This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.

Wnt ligands from the embryonic surface ectoderm regulate 'bimetallic strip' optic cup morphogenesis in mouse.

The Wnt/ß-catenin response pathway is central to many developmental processes. Here, we assessed the role of Wnt signaling in early eye development using the mouse as a model system. We showed that the surface ectoderm region that includes the lens placode expressed 12 out of 19 possible Wnt ligands. When these activities were suppressed by conditional deletion of wntless (Le-cre; Wls(fl/fl)) there were dramatic consequences that included a saucer-shaped optic cup, ventral coloboma, and a deficiency of periocular mesenchyme. This phenotype shared features with that produced when the Wnt/ß-catenin pathway co-receptor Lrp6 is mutated or when retinoic acid (RA) signaling in the eye is compromised. Consistent with this, microarray and cell fate marker analysis identified a series of expression changes in genes known to be regulated by RA or by the Wnt/ß-catenin pathway. Using pathway reporters, we showed that Wnt ligands from the surface ectoderm directly or indirectly elicit a Wnt/ß-catenin response in retinal pigment epithelium (RPE) progenitors near the optic cup rim. In Le-cre; Wls(fl/fl) mice, the numbers of RPE cells are reduced and this can explain, using the principle of the bimetallic strip, the curvature of the optic cup. These data thus establish a novel hypothesis to explain how differential cell numbers in a bilayered epithelium can lead to shape change.

Multicenter Testing of a Risk Assessment Survey for Soft Contact Lens Wearers With Adverse Events: A Contact Lens Assessment in Youth Study.

PURPOSE: To test the ability of responses to the Contact Lens Assessment in Youth (CLAY) Contact Lens Risk Survey (CLRS) to differentiate behaviors among participants with serious and significant (S&S) contact lens-related corneal inflammatory events, those with other events (non-S&S), and healthy controls matched for age, gender, and soft contact lens (SCL) wear frequency. METHODS: The CLRS was self-administered electronically to SCL wearers presenting for acute clinical care at 11 clinical sites. Each participant completed the CLRS before their examination. The clinician, masked to CLRS responses, submitted a diagnosis for each participant that was used to classify the event as S&S or non-S&S. Multivariate logistic regression analyses were used to compare responses. RESULTS: Comparison of responses from 96 participants with S&S, 68 with non-S&S, and 207 controls showed that patients with S&S were more likely (always or fairly often) to report overnight wear versus patients with non-S&S (adjusted odds ratio [aOR], 5.2; 95% confidence interval [CI], 1.4-18.7) and versus controls (aOR, 5.8; CI, 2.2-15.2). Patients with S&S were more likely to purchase SCLs on the internet versus non-S&S (aOR, 4.9; CI, 1.6-15.1) and versus controls (aOR, 2.8; CI, 1.4-5.9). The use of two-week replacement lenses compared with daily disposables was significantly higher among patients with S&S than those with non-S&S (aOR, 4.3; CI, 1.5-12.0). Patients with S&S were less likely to regularly discard leftover solution compared with controls (aOR, 2.5; CI, 1.1-5.6). CONCLUSIONS: The CLRS is a clinical survey tool that can be used to identify risky behaviors and exposures directly associated with an increased risk of S&S events.

Contact Lens Wearer Demographics and Risk Behaviors for Contact Lens-Related Eye Infections--United States, 2014.

Contact lenses provide safe and effective vision correction for many Americans. However, contact lens wearers risk infection if they fail to wear, clean, disinfect, and store their contact lenses as directed. Over the past decade, CDC has investigated several multistate outbreaks of serious eye infections among contact lens wearers, including Acanthamoeba keratitis. Each investigation identified frequent contact lens hygiene-related risk behaviors among patients. To guide prevention efforts, a population-based survey was used to estimate the number of contact lens wearers aged ≥18 years in the United States. A separate online survey of contact lens wearers assessed the prevalence of contact lens hygiene-related risk behaviors. Approximately 99% of wearers reported at least one contact lens hygiene risk behavior. Nearly one third of contact lens wearers reported having experienced a previous contact lens-related red or painful eye requiring a doctor's visit. An estimated 40.9 million U.S. adults wear contact lenses, and many could be at risk for serious eye infections because of poor contact lens wear and care behaviors. These findings have informed the creation of targeted prevention messages aimed at contact lens wearers such as keeping all water away from contact lenses, discarding used disinfecting solution from the case and cleaning with fresh solution each day, and replacing their contact lens case every 3 months.

Age, behavior, environment, and health factors in the soft contact lens risk survey.

PURPOSE: Previous studies have reported that the risk of corneal infectious and inflammatory events (CIEs) with soft contact lens (SCL) wear is highest in late adolescence and early adulthood. This study assesses the associations between patient age and other factors that may contribute to CIEs in young SCL wearers. METHODS: After ethics approvals and informed consent, a nonclinical population of young SCL wearers was surveyed in five US cities. Data from 542 SCL wearers aged 12-33 years were collected electronically. Responses were analyzed by age bins (12-14, 15-17, 18-21, 22-25, 26-29, and 30-33 years) using chi-square test. RESULTS: The cohort was 34% male and balanced across age bins. There were several significant associations between survey response and age (in bins). Wearers aged 18-21 years reported more recent nights with less than 6 hours of sleep (p < 0.001), more colds/flu (p = 0.049), and higher stress levels (p < 0.001). Wearers 18-21 and those 22-25 years were more likely to wear SCLs when showering (p < 0.001) and also reported more frequent naps with SCLs (p < 0.001). They reported sleeping in SCLs after alcohol use (p = 0.031), when traveling (p = 0.001), and when away from home (p = 0.024). Lower rates of regular hand washing before lens application (p = 0.054) was also associated with these groups. In addition, the relationship between reactive replacement and recommended replacement was dependent on age (p < 0.0001). CONCLUSIONS: Patient age influences lens wearing behaviors, environmental exposures, and other determinants of health that may contribute to increased CIEs in younger wearers. Targeted, age-specific education should be considered for both new and established SCL wearers.

Biospecimen Qualification in a Clinical Biobank of Urological Diseases.

Development of novel biomarkers for diagnosis of disease and assessment of treatment efficacy utilizes a wide range of biospecimens for discovery research. The fitness of biospecimens for the purpose of biomarker development depends on the clinical characteristics of the donor and on a number of critical and potentially uncontrolled pre-analytical variables. Pre-analytical factors influence the reliability of the biomarkers to be analyzed and can seriously impact analytic outcomes. Sample quality stratification assays and tools can be utilized by biorepositories to minimize bias resulting from samples' inconsistent quality. In this study, we evaluated the quality of biobanked specimens by comparing analytical outcomes at 1, 5, and 10 years after collection. Our results demonstrate that currently available assays and tools can be used by biobank laboratories to support objective biospecimen qualification. We have established a workflow to monitor the quality of different types of biospecimens and, in this study, present the results of a qualification exercise applied to fluid samples and their derivatives in the context of urological diseases.

Risk factors for interruption to soft contact lens wear in children and young adults.

PURPOSE: The purpose of this study was to describe age and other risk factors for ocular events that interrupt soft contact lens (SCL) wear in youth. METHODS: A retrospective chart review of SCL wearers aged 8 to 33 years at the first observed visit was conducted at six academic eye care centers in North America. Data were extracted from all visits during the observation period (>3 years). Clinical records that documented conditions resulting in an interruption of SCL wear "events" were scanned, masked for age and SCL parameters, and then adjudicated to consensus diagnosis. Generalized estimating equations were used to examine the effect of selected covariates, including age, on the risk of an event. RESULTS: Chart review of 3549 SCL wearers yielded 522 events among 426 wearers (12%). The risk of an event increased from ages 8 to 18 years, showed modest increases between ages 19 and 25 years, and then began to decline after age 25 years. New lens wearers (<1 year) were less likely to experience events (p = 0.001). Lens replacement schedule and material were also predictive of interruptions to SCL wear with the lowest risk in daily replacement and hydrogel lens wearers (both p < 0.0001). CONCLUSIONS: These results suggest that the risk of events that interrupt SCL wear peaks in late adolescence and early adulthood and reflects risk factors identified in prospective contact lens studies. Relative to older teens and young adults, patients younger than 14 years presented with significantly fewer events resulting in interrupted lens wear.

Contact lens assessment in youth: methods and baseline findings.

PURPOSE: To describe the Contact Lens Assessment in Youth (CLAY) Study design and report baseline data for a multicenter, retrospective, observational chart review of children, teenagers, and young adult soft contact lens (SCL) wearers. METHODS: Clinical charts of SCL wearers aged 8 to 33 years were reviewed at six colleges of optometry. Data were captured retrospectively for eye care visits from January 2006 through September 2009. Patient demographics, SCL parameters, wearing schedules, care systems, and biomicroscopy findings and complications that interrupted SCL wear were entered into an online database. RESULTS: Charts from 3549 patients (14,276 visits) were reviewed; 78.8% were current SCL wearers and 21.2% were new fits. Age distribution was 8 to <13 years (n = 260, 7.3%), 13 to <18 years (n = 879, 24.8%), 18 to <26 years (n = 1,274, 36.0%), and 26 to <34 years (n = 1,136, 32.0%). The sample was 63.2% females and 37.7% college students. At baseline, 85.2% wore spherical SCLs, 13.5% torics, and 0.1% multifocals. Silicone hydrogel lenses were worn by 39.3% of the cohort. Daily wear was reported by 82.1%, whereas 17.9% reported any or occasional overnight wear. Multipurpose care systems were used by 78.1%, whereas another 9.9% indicated hydrogen peroxide solutions use. CONCLUSIONS: This data represent the SCL prescribing and wearing patterns for children, teenager, and young adult SCL wearers who presented for eye care in North American academic clinics. This will provide insight into SCL utilization, change in SCL refractive correction, and risk factors for SCL-related complications by age group.

Biorepositories and Databanks for the Development of Novel Biomarkers for Genitourinary Cancer Prevention and Management.

CONTEXT: Translational research in uro-oncology depends on the availability of high-quality biospecimens and associated data to advance precision medicine and improve clinical outcomes. Procurement, storage, and annotation of these specimens represent critical steps towards this end. OBJECTIVE: To review best-practice experiences gained via the McCain GU BioBank, a repository of more than 750 000 biospecimens obtained from more than 16 000 patients attending clinics at the University Health Network in Toronto, Canada. EVIDENCE ACQUISITION: The review summarizes our experiences at a large single-institution genitourinary oncology biorepository. EVIDENCE SYNTHESIS: Key findings are placed in the context of emerging trends in genitourinary oncology, with a focus on integration of molecular profiling and clinical data with traditional biorepository management. Proposed approaches provide high-quality biospecimens with comprehensive and reliable clinical data that can fuel innovation and discovery in research. CONCLUSIONS: Biorepositories are vital for improving clinical outcomes and advancing personalized medicine. High-quality biospecimens and their associated clinical data are crucial for validation of biomarkers in oncology. Efforts to procure, store, and annotate clinical specimens represent critical steps in translational research. Elements such as biobank size, biospecimen types, disease cohorts, predetermined collection protocols, broad informed consent, sample handling and storage protocols, and available infrastructure directly influence the effectiveness and capacity of a biobank. PATIENT SUMMARY: Biorepositories, or biobanks, are facilities that store biospecimens such as blood, urine, or tissue (usually collected from humans) for use in research. Biobanks have become an important resource in medical research, as they provide high-quality specimens to support different types of contemporary research such as genomics, biomarker discovery, and personalized medicine. Clinical management and treatment of genitourinary cancers, such as prostate, kidney, and bladder cancers, are particularly suited for biomarker research. The provision of biospecimens and their associated clinical data have become crucial for validation of biomarkers in these cancers.

Development of a contact Lens risk survey.

PURPOSE: To describe the development and report psychometric properties of the Contact Lens Risk Survey (CLRS) to identify patients at risk for soft contact lens-related complications. METHODS: Psychometric properties of the CLRS, a web-based survey with branching logic, were determined using data from 5 multi-site fieldings (n = 1059), including re-fielding to sub groups. Responses from participants with and without an active red eye were used to identify risk factors of a red eye event and calculate an overall risk score. A 6th fielding of the CLRS (n = 171) was used to assess discriminate validity. RESULTS: Participants needed 11-12 min to complete the survey with a negligible difference by age. Internal consistency was excellent (Cronbach's α ≥ 0.70) for 3 of the 5 constructs identified by factor analysis. Twelve of the 17 survey items exhibited excellent within-subject repeatability (Kappa ≥ 0.61). Between-subject agreement, assessed in 18-25 year olds, was high for the majority of items, suggesting good generalizability across different populations of SCL wearers. The ability of the model using individual items of the CLRS to discriminate Controls and participants with a red eye was good with an area under the curve of 0.779. CONCLUSION: The CLRS tool is a repeatable and valid instrument to standardize documentation of demographic, behavior, and exposure factors which appear to drive the greatest risk of a contact lens related red eye event.

The contact Lens risk survey to assess risk of soft contact lens-related inflammatory events.

PURPOSE: To test the Contact Lens Assessment in Youth Contact Lens Risk Survey (CLRS) scoring algorithm in soft contact lens (SCL) wearers presenting with SCL-related adverse events and healthy matched controls. METHODS: This prospective case-control study compared CLRS responses in SCL wearers presenting with symptomatic red eyes (Cases) with age-, sex- and site-matched healthy SCL wearers (Controls) at six locations across North America. Responses to individual questions from Cases and Controls were analyzed using either the Pearson, Mantel-Haenszel chi-square, or Fisher's exact test. Differences in the CLRS scores were compared using t-tests. RESULTS: A total of 171 SCL wearers were enrolled (n = 57 Cases, 114 Controls). Cases were adjudicated to consensus and classified as contact lens-related serious and significant (S&S) or non-serious events. S&S Cases scored significantly higher on the CLRS (56.1 ±â€¯11.1) than either their matched Controls (44.3 ±â€¯11.1) (P <  0.001) or the non-Serious Cases (44.8± 12.8 P =  0.002). Scores of non-serious Cases were not significantly different than scores of their Controls (43.4 ± 10.7, P = 0.33) CONCLUSIONS: The CLRS scoring algorithm discriminated between SCL wearers presenting with S&S CL-related adverse events from healthy SCL wearers and those with non-serious events. This survey and scoring system could help practitioners identify patients at greatest risk for CL-related adverse events and support targeted interventions aimed at reducing risk behaviors.

CLEAR - Contact lens complications.

Contact lens-related complications are common, affecting around one third of wearers, although most are mild and easily managed. Contact lenses have well-defined anatomical and physiological effects on the ocular surface and can result in other consequences due to the presence of a biologically active material. A contact lens interacts with the tear film, ocular surface, skin, endogenous and environmental microorganisms, components of care solutions and other antigens which may result in disease specific to contact lens wear, such as metabolic or hypersensitivity disorders. Contact lens wear may also modify the epidemiology or pathophysiology of recognised conditions, such as papillary conjunctivitis or microbial keratitis. Wearers may also present with intercurrent disease, meaning concomitant or pre-existing conditions unrelated to contact lens wear, such as allergic eye disease or blepharitis, which may complicate the diagnosis and management of contact lens-related disease. Complications can be grouped into corneal infection (microbial keratitis), corneal inflammation (sterile keratitis), metabolic conditions (epithelial: microcysts, vacuoles, bullae, tight lens syndrome, epithelial oedema; stromal: superficial and deep neovascularisation, stromal oedema [striae/folds], endothelial: blebs, polymegethism/ pleomorphism), mechanical (corneal abrasion, corneal erosion, lens binding, warpage/refractive error changes; superior epithelial arcuate lesion, mucin balls, conjunctival epithelial flaps, ptosis, discomfort), toxic and allergic disorders (papillary conjunctivitis, solution-induced corneal staining, incomplete neutralisation of peroxide, Limbal Stem Cell Deficiency), tear resurfacing disorders/dry eye (contact lens-induced dry eye, Meibomian gland dysfunction, lid wiper epitheliopathy, lid parallel conjunctival folds, inferior closure stain, 3 and 9 o'clock stain, dellen, dimple veil) or contact lens discomfort. This report summarises the best available evidence for the classification, epidemiology, pathophysiology, management and prevention of contact lens-related complications in addition to presenting strategies for optimising contact lens wear.

Ovarian yolk sac tumor associated with major fibrosarcoma component in a 13-year-old girl.

We are presenting a case of a 13-year-old girl with a chief complaint of lower abdominal pain. A computed tomographic scan showed a 10-cm right ovarian mass. The serologic testing showed high alpha-fetoprotein level. The patient underwent a right adnexectomy and an omentectomy. The final diagnosis was a yolk sac tumor with a major (95%) fibrosarcoma component, based on morphology and further confirmed by an extensive panel of immunohistochemistry. Postoperatively, the alpha-fetoprotein level dropped to normal. The patient completed 7 cycles of multiagent chemotherapy with cisplatin without major complications. At her 7-month follow-up, the patient still remains disease free. To our knowledge, our case is the first of its kind in the literature to document yolk sac tumor associated with fibrosarcoma in a teenage female. Owing to the rarity of this entity, the prognosis of this patient is widely unknown and it is yet still to be seen.

Submission of the entire lymph node dissection for histologic examination in gynecologic-oncologic specimens. Clinical and pathologic relevance.

BACKGROUND AND AIMS: Lymph node (LN) status in gynecologic malignancies plays an important role in patient staging, management, and prognosis. Therefore, an adequacy of LN harvest is crucial. The aim of this study is to determine whether the submission of the entire LN dissection for histologic examination will affect patients' outcome or clinical stage. We also evaluated the time required and cost-effectiveness for the laboratory. MATERIALS AND METHODS: A prospective study of 134 surgical cases from various gynecologic malignancies was conducted. The LN dissection specimen was performed using a conventional manual node dissection method with all the remaining fat being submitted in additional cassettes. One pathologist evaluated (1) the number and status of palpable LNs identified by the conventional method as well as the number of tissue cassettes and (2) the number, size, and status of the non-palpable LNs as well as the number of tissue cassettes. RESULTS: The palpable LNs ranged from 0 to 36 with average 14.8 LNs per case (Poisson 95% CI: 14.1-15.4). The additional non-palpable LNs ranged from 0 to 16 with an average of 3.1 (Poisson 95% CI: 2.8-3.4). In only one case, a 3-mm non-palpable LN with metastasis was identified; however, it did not affect tumor staging or patient management. CONCLUSION: The impact on patient outcome is minimal and it does not prove to be cost and time effective when submitting the entire LN dissection specimen in gynecologic malignancies. However, this method could be justified in selective cases in which the manual node dissection does not reveal an adequate number of LNs.