Cognitive, Motor, and Language Development of Preschool Children With Craniofacial Microsomia.

OBJECTIVE: To examine neurodevelopment in preschool-aged children with craniofacial microsomia (CFM) relative to unaffected peers. DESIGN: Multisite, longitudinal cohort study. SETTING: Tertiary care centers in the United States. PARTICIPANTS: We included 92 children with CFM ("cases") through craniofacial centers and clinics. Seventy-six children without CFM (controls) were included from pediatric practices and community advertisements. This study reports on outcomes assessed when participants were an average age of 38.4 months (SD = 1.9). MAIN OUTCOME MEASURES: We assessed cognitive and motor skills using the Bayley Scales of Infant and Toddler Development, third edition (Bayley-III), and language function using subtests from the Clinical Evaluation of Language Fundamentals-Preschool, second edition (CELF-P2). RESULTS: Case-control differences were negligible for Bayley-III cognitive (effect sizes [ES] = -0.06, P = .72) and motor outcomes (ES = -0.19, P = .25). Cases scored lower than controls on most scales of the CELF-P2 (ES = -0.58 to -0.20, P = .01 to .26). Frequency counts for "developmental delay" (ie, one or more scores > 1 SD below the normative mean) were higher for cases (39%) than controls (15%); however, the adjusted odds ratio = 1.73 (P = 0.21) was not significant. Case-control differences were most evident in children with microtia or other combinations of CFM-related facial features. CONCLUSIONS: Cognitive and motor scores were similar for preschool-aged children with and without CFM. However, children with CFM scored lower than controls on language measures. We recommend early monitoring of language to identify preschoolers with CFM who could benefit from intervention.

Behavioral Adjustment of Preschool Children With and Without Craniofacial Microsomia.

OBJECTIVE: The study aim was to assess behavioral adjustment in preschool children with and without craniofacial microsomia (CFM). DESIGN: Multisite cohort study of preschoolers with CFM ("cases") or without CFM ("controls"). PARTICIPANTS: Mothers (89%), fathers (9%), and other caregivers (2%) of 161 preschoolers. OUTCOME MEASURE: Child Behavior Check List (CBCL 1.5-5); linear regressions with standardized effect sizes (ES) adjusted for sociodemographic confounds. RESULTS: Child Behavior Check Lists for 89 cases and 72 controls (average age 38.3 ± 1.9 months). Children were male (54%), white (69%), and of Latino ethnicity (47%). Cases had microtia with mandibular hypoplasia (52%), microtia only (30%), or other CFM-associated features (18%). Nearly 20% of cases had extracranial anomalies. Composite CBCL scores were in the average range compared to test norms and similar for cases and controls. On the subscales, cases' parents reported higher Anxious/Depressed scores (ES = 0.35, P = .04), Stress Problems (ES = 0.40, P = .04), Anxiety Problems (ES = 0.34, P = .04), and Autism Spectrum Problems (ES = 0.41, P = .02); however, the autism subscale primarily reflected speech concerns. Among cases, more problems were reported for children with extracranial anomalies and certain phenotypic categories with small ES. CONCLUSIONS: Behavioral adjustment of preschoolers with CFM was comparable to peers. However, parental reports reflected greater concern for internalizing behaviors; thus, anxiety screening and interventions may benefit children with CFM. Among cases, more problems were reported for those with more complex presentations of CFM. Craniofacial microsomia-related speech problems should be distinguished from associated psychosocial symptoms during developmental evaluations.

Methods and Challenges in a Cohort Study of Infants and Toddlers With Craniofacial Microsomia: The Clock Study.

OBJECTIVE: The Craniofacial microsomia: Longitudinal Outcomes in Children pre-Kindergarten (CLOCK) study is a longitudinal cohort study of neurobehavioral outcomes in infants and toddlers with craniofacial microsomia (CFM). In this article, we review the data collection and methods used to characterize this complex condition and describe the demographic and clinical characteristics of the cohort. SETTING: Craniofacial and otolaryngology clinics at 5 study sites. PARTICIPANTS: Infants with CFM and unaffected infants (controls) ages 12 to 24 months were recruited from the same geographical regions and followed to age 36 to 48 months. METHODS: Phenotypic, neurodevelopmental, and facial expression assessments were completed during the first and third waves of data collection (time 1 and time 3, respectively). Medical history data were taken at both of these time points and during an intermediate parent phone interview (time 2). RESULTS: Our cohort includes 108 cases and 84 controls. Most cases and controls identified as white and 55% of cases and 37% of controls identified as Hispanic. Nearly all cases had microtia (95%) and 59% had mandibular hypoplasia. Cases received extensive clinical care in infancy, with 59% receiving care in a craniofacial clinic and 28% experiencing at least one surgery. Study visits were completed at a study site (92%) or at the participant's home (8%). CONCLUSIONS: The CLOCK study represents an effort to overcome the challenges of characterizing the phenotypic and neurodevelopmental outcomes of CFM in a large, demographically and geographically diverse cohort.

Hearing Loss in Children With Craniofacial Microsomia.

OBJECTIVE: To evaluate the association between craniofacial phenotype and hearing loss in children with craniofacial microsomia. DESIGN: Retrospective cohort study. SETTING: Tertiary care children's hospital. PATIENTS: Individuals with craniofacial microsomia. MAIN OUTCOME MEASURES: Ear-specific audiograms and standardized phenotypic classification of facial characteristics. RESULTS: A total of 79 participants were included in the study. The mean age was 9 years (range, 1 to 23 years) and approximately 60% were boys. Facial anomalies were bilateral in 39 participants and unilateral in 40 participants (24 right, 16 left). Microtia (hypoplasia of the ear) was the most common feature (94%), followed by mandibular hypoplasia (76%), soft tissue deficiency (60%), orbital hypoplasia or displacement (53%), and facial nerve palsy (32%). Sixty-five individuals had hearing loss (12 bilateral and 53 unilateral). Hearing loss was conductive in 73% of affected ears, mixed in 10%, sensorineural in 1%, and indeterminate in 16%. Hypoplasia of the ear or mandible was frequently associated with ipsilateral hearing loss, although contralateral hearing loss occurred in 8% of hemifaces. CONCLUSIONS: Hearing loss is strongly associated with malformations of the ipsilateral ear in craniofacial microsomia and is most commonly conductive. Hearing loss can occur contralaterally to the side with malformations in children with apparent hemifacial involvement. Children with craniofacial microsomia should receive early diagnostic hearing assessments.

Ophthalmic viscoelastic devices as a cleaning challenge.

Common practice when validating the cleaning of medical devices is to employ clinically relevant test soils as a challenge to the cleaning process. During use, medical devices may come into contact with a variety of materials that are difficult to clean. One example of this is the use of ophthalmic viscoelastic devices (OVDs) in cataract surgery. This study evaluated the effectiveness of a procedure for cleaning the lumens of a phacoemulsification handpiece using two different OVDs as test soils. The results of this study demonstrate that effective cleaning of the aspiration and irrigation lumens of a phacoemulsification handpiece may be achieved if the manufacturer's recommended cleaning procedures are followed.

Sensitivity to Deaf Culture Among Otolaryngology and Audiology Trainees.

OBJECTIVE: The Deaf community is an ethnolinguistic minority group. Low sensitivity to Deaf culture contributes to health disparities among Deaf patients. This study determines the level of sensitivity to Deaf culture among otolaryngology-head and neck surgery (OHNS) and audiology trainees. METHODS: Cross-sectional survey study of OHNS and audiology trainees from 10 large US institutions. Trainees were queried on their exposure to and comfort with Deaf patients and their education on, attitude toward, and awareness and knowledge of Deaf culture. Sensitivity to Deaf culture was operationalized as awareness and knowledge of Deaf culture. These were assessed using a 35-item instrument that was previously developed using a d/Deaf community-based participatory approach to research. We used T-tests to compare the sample to previous samples of medical students with training in Deaf culture (MS-TDCs) and general practitioners (GPs). RESULTS: There were 91 completed surveys (response rate 44.5%). Almost all were aware of Deaf culture (97.8%). The mean knowledge score was 55.0% (standard deviation (SD) 13.4%), which was significantly higher than that for GPs at 43.0% (SD 15.0%) (95% confidence interval 8.1%, 15.8%, P < .0001) but significantly lower than that for MS-TDCs at 69.0% (SD 13.0%)(CI -20.3%, -7.6%, P < .0001). Knowledge scores were comparable for OHNS and audiology trainees (P = .09). CONCLUSION: This sample of OHNS and audiology trainees was more sensitive to Deaf culture than GPs but less sensitive than MS-TDCs. Developing specialty-specific education may be warranted. LEVEL OF EVIDENCE: 4.

Psychoacoustic performance and music and speech perception in prelingually deafened children with cochlear implants.

The number of pediatric cochlear implant (CI) recipients has increased substantially over the past 10 years, and it has become more important to understand the underlying mechanisms of the variable outcomes in this population. In this study, psychoacoustic measures of spectral-ripple and Schroeder-phase discrimination, the Clinical Assessment of Music Perception, and consonant-nucleus-consonant (CNC) word recognition in quiet and spondee reception threshold (SRT) in noise tests have been presented to 11 prelingually deafened CI users, aged 8-16 years with at least 5 years of CI experience. The children's performance was compared to the previously reported results of postlingually deafened adult CI users. The average spectral-ripple threshold (n = 10) was 2.08 ripples/octave. The average Schroeder-phase discrimination was 67.3% for 50 Hz and 56.5% for 200 Hz (n = 9). The Clinical Assessment of Music Perception test showed that the average complex pitch direction discrimination was 2.98 semitones. The mean melody score was at a chance level, and the mean timbre score was 34.1% correct. The mean CNC word recognition score was 68.6%, and the mean SRT in steady noise was -8.5 dB SNR. The children's spectral-ripple resolution, CNC word recognition, and SRT in noise performances were, within statistical bounds, the same as in a population of postlingually deafened adult CI users. However, Schroeder-phase discrimination and music perception were generally poorer than in the adults. It is possible then that this poorer performance seen in the children might be partly accounted for by the delayed maturation in their temporal processing ability, and because of this, the children's performance may have been driven more by their spectral sensitivity.

A new method for evaluation of compatibility of contact lenses and lens cases with contact lens disinfecting solutions.

PURPOSE: The purpose of this article is to describe new methodology, antimicrobial efficacy endpoint methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection (AEEMC), to evaluate the effect of a contact lens and a lens case on disinfection efficacy, and to present the ring test used to justify the use of the method in multiple laboratories. MATERIALS AND METHODS: A prototype solution containing chlorhexidine as the disinfecting agent and four representative lens types (group I and IV hydrogels and two silicone hydrogels) were used in these ring tests. Five laboratories participated in the chemical and microbiologic analyses. The residual chlorhexidine in lens cases containing the contact lenses was determined using high-performance liquid chromatography; uptake by the lenses was then determined by extrapolation. For the microbiologic part of the study, a contact lens was placed in the well of the lens case, inoculated at 10 to 10 cfu (colony forming units) per lens with microorganisms in 10% organic soil. The microorganisms, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Candida albicans, and Fusarium solani, were prepared as in International Organization for Standardization (ISO) 14729. After a 3- to 10-min exposure time, the prototype solution was dispensed into each well. Aliquots of the inoculated solutions were removed at 4 and 24 hrs and 7 and 30 days and cultured in neutralizing media for determination of survivors; lenses were also cultured for survivors. RESULTS: Chemical uptake data confirmed the differences observed in kill of the challenge organisms according to lens type. It was observed that the culturing of the solution provided adequate data to show the effect of a lens on disinfection efficacy of a lens care product. The findings of the ring test indicated that the separate culturing of the contact lenses is not necessary for routine assessment. CONCLUSIONS: The methodology in the November 12, 2008, draft standard (AEEMC), meets the stated objective of demonstrating the effect of a contact lens on the disinfection efficacy of a simulated lens care product. This method, used in combination with the methodology in ISO 14729, should provide for a more robust evaluation of applicable contact lens care disinfecting products.

Performing tympanometry using smartphones.

Background: Tympanometry is used as part of a battery of tests for screening of middle ear function and may help diagnose middle ear disorders, but remains available only on expensive test equipment. Methods: We report a low-cost smartphone-based tympanometer system that consists of a lightweight and portable attachment to vary air pressure in the ear and measure middle ear function. The smartphone displays a tympanogram and reports peak acoustic admittance in realtime. Our programmable and open-source system operates at 226 Hz and was tested on 50 pediatric patient ears in an audiology clinic in parallel with a commercial tympanometer. Results: Our study shows an average agreement of 86 ± 2% between the 100 tympanograms produced by the smartphone and commercial device when five pediatric audiologists classified them into five classes based on the Liden and Jerger classification. Conclusion: Given the accessibility and prevalence of budget smartphones in developing countries, our open-source tool may help provide timely and affordable screening of middle ear disorders.

Educational Environments and Secondary School Outcomes Among Students Who Are D/deaf and Hard of Hearing in Special Education.

PURPOSE: The purpose of this study is to provide updated national estimates on the annual number, educational environments, and secondary school outcomes of students who are D/deaf and hard of hearing (D/HH) receiving special education (SpEd) and related services in the United States. METHOD: We performed a retrospective cross-sectional descriptive analysis of Individuals with Disabilities Education Act, Part B, Section 618 data from 2012 to 2018. Participants included students 6-21 years old in SpEd with "hearing impairment" reported as their primary disability. The general population of students in secondary school served as a comparator, via Current Population Survey data. We described the annual number of students (a) overall, (b) by educational environment, and (c) by reason for exiting SpEd, including the proportion graduating from and dropping out of secondary school. We described variation over time. RESULTS: The median annual number of students was 67,655, with minimal variation by year. The proportion in general education (GenEd) for ≥ 80% of the day increased by 4.2% over 6 years from 57.8% to 62.0%, whereas the proportions in GenEd for < 40% and 40%-79% of the day decreased by 1.6% and 1.3%, respectively. Proportions in the remainder of the environments changed < 1.0% each. Of exiters, 86.8% of students graduated, whereas 3.9% dropped out, compared to a dropout rate of 5.0% in the general population. CONCLUSION: From 2012 to 2018, students who are D/HH receiving SpEd in the United States have spent increasingly more time in GenEd, most graduated from high school, and few dropped out, with dropout patterns appearing similar to the general population.

Defining Essential Services for Deaf and Hard of Hearing Children during the COVID-19 Pandemic.

COVID-19 is a rapidly growing global pandemic caused by a novel coronavirus. With no vaccine or definitive treatment, public health authorities have recommended a strategy of "social distancing," reducing individual interaction, canceling elective procedures, and limiting nonessential services. Health care providers must determine what procedures are considered "elective," balancing risk of treatment delays with that of coronavirus exposure to patient, family, and providers. Given critical periods for language development and the long-term impact of auditory deprivation, some audiologic and otologic services should be considered essential. In this article, we describe the experience of a quaternary referral pediatric hospital in Seattle, the epicenter of COVID-19 in the United States, and share strategies for risk minimization employed by Seattle Children's Hospital. We hope that this work can be a reference for other centers continuing care for children who are deaf and hard of hearing during the COVID-19 and future resource-limiting crises.

Reliability of Measuring Insertion Depth in Cochlear Implanted Infants and Children Using Cochlear View Radiography.

OBJECTIVES: Cochlear implant depth of insertion affects audiologic outcomes and can be measured in adults using plain films obtained in the "cochlear view." The objective of this study was to assess interrater and intrarater reliability of measuring depth of insertion using cochlear view radiography. STUDY DESIGN: Prospective, observational. SETTING: Tertiary referral pediatric hospital. SUBJECTS AND METHODS: Patients aged 11 months to 20 years (median, 4 years; interquartile range [IQR], 1-8 years) undergoing cochlear implantation at our institution were studied over 1 year. Children underwent cochlear view imaging on postoperative day 1. Films were deidentified and 1 image per ear was selected. Two cochlear implant surgeons and 2 radiologists evaluated each image and determined angular depth of insertion. Images were re-reviewed 6 weeks later by all raters. Inter- and intrarater reliability were calculated with intraclass correlation coefficients (ICCs). RESULTS: Fifty-seven ears were imaged from 42 children. Forty-nine ears (86%) had successful cochlear view x-rays. Median angular depth of insertion was 381° (minimum, 272°; maximum, 450°; IQR, 360°-395°) during the first round of measurement. Measurements of the same images reviewed 6 weeks later showed median depth of insertion of 382° (minimum, 272°; maximum, 449°; IQR, 360°-397°). Interrater and intrarater reliability ICCs ranged between 0.81 and 0.96, indicating excellent reliability. CONCLUSIONS: Postoperative cochlear view radiography is a reliable tool for measurement of cochlear implant depth of insertion in infants and children. Further studies are needed to determine reliability of intraoperatively obtained cochlear view radiographs in this population.

Auditory comprehension outcomes in children who receive a cochlear implant before 12 months of age.

OBJECTIVE: The U.S. Food and Drug Administration guidelines for cochlear implantation (CI) include age greater than 12 months. Studies have suggested that implantation in children younger than 12 months with congenital deafness may be associated with better spoken language outcomes. Compare auditory comprehension (AC) outcomes for children with congenital deafness who received CI less than 12 months of age to those implanted at 12 to 24 months of age. METHODS: Retrospective review of prospectively collected data in consecutively implanted patients under 2 years of age who received CI and had post-CI Preschool Language Scale (PLS)-AC scores. Receptive language was assessed with the AC subtest of the PLS. Patients without pre-CI PLS-AC scores were excluded. The association between age at implantation and post-CI PLS-AC scores up to 2 years after CI surgery was modeled using a linear mixed-effects model. Time from CI surgery, number of implants, risk factors for language delay, pre-CI PLS-AC score, and sex were included in the model. Patients implanted less than 12 months of age were compared to those implanted between 12 and 24 months. RESULTS: Twenty-nine patients who had CI surgery by 12 months and 82 who had CI surgery between 12 and 24 months were included in the analysis. Younger age at implantation and better pre-CI PLS-AC scores were significantly associated with better post-CI PLS-AC scores. CONCLUSION: Cochlear implantation in children with congenital deafness less than 12 months of age was associated with better PLS-AC than in children implanted over 12 months of age up to 2 years after implantation. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:776-781, 2020.

Measuring sound detection and reaction time in infant and toddler cochlear implant recipients using an observer-based procedure: a first report.

OBJECTIVES: First, to establish the feasibility of the observer-based psychophysical procedure (OPP) in measuring sound detection in infant and toddler cochlear implant (CI) recipients. Second, to measure the psychometric function for detection (PFD) from individual subjects. Third, to determine whether reaction time (RT) provides information about the auditory sensitivity of young CI users. DESIGN: Twelve CI recipients, 11 to 32 mo old, participated in our study. Initially, tones were presented in sound field, and children learned to respond when they heard tones but not at other times. Once an 80% correct criterion was met in sound field, a novel stimulation paradigm was used to present stimuli to a single electrode while the child listened to acoustic input on most other electrodes using their usual map. The PFD and RT were measured using this single-electrode stimulation paradigm. RESULTS: Eleven subjects met criterion, 6 within the minimum possible number of trials. For eight subjects, the asymptotic level of detecting single-electrode stimuli averaged 86% correct, similar to levels achieved by normal-hearing infants and toddlers detecting pure tones. The PFD slope of infant and toddler CI recipients was less than or equal to the slope for adult CI users reported in previous studies. RT decreased significantly with stimulus level in four children. CONCLUSIONS: These preliminary results suggest that psychophysical detection data can be obtained from infant and toddler CI recipients using OPP. The PFD of young CI users may be shallower than that of adult CI users. Relatively good asymptotic detection performance implies that young CI users are more attentive to sound than has been suggested in previous studies. RT tended to be a less reliable measure of detection, but methodological changes could improve its utility.

Selecting Comparator Sites for Ecological Causal Assessment Based on Expected Biological Similarity.

Sites in poor ecological condition often require causal assessment to determine appropriate follow-up actions. Site-specific causal assessments can be time consuming. To streamline the process, we describe a quantitative method that expedites a key component of causal assessment: identifying a group of ecologically similar (comparator) sites that are used to compare and contrast biological condition and stressor exposure at the site of interest. A good set of comparator sites should: 1. Be capable of supporting similar biota to the impaired site in the absence of disturbance; 2. Comprise a gradient of biotic condition; and 3. Contain enough sites to assess variability. We used expected biological similarity to select good sets of comparator sites from a large pool of potential sites. Expected biological similarity was measured as Bray-Curtis dissimilarity values (BC) calculated from the expected benthic macroinvertebrate taxa lists produced by a predictive biotic index of stream health. Sets of comparator sites were created for 15 demonstration sites across Southern California in poor condition. We examined the stressor and biological data collected at the 15 sites and their comparators to assess the likelihood that four example stressors - total nitrogen, ammonia, specific conductivity, and bifenthrin - contribute to the poor biotic conditions that were observed. We were able to select more than 100 comparator sites for all but 1 of the 15 demonstration sites at a BC <0.1. These sets of comparator sites were then used to evaluate the four example stressors using two commonly used causal assessment types of evidence. Elevated conductivity was the most frequently supported likely cause among the demonstration sites, though total nitrogen and bifenthrin were also indicated at some sites. Though our specific approach was tailored for application in California's stream bioassessment framework, the concepts could be adapted for any bioassessment program with a large amount of sample data and an associated predictive index of biotic condition. Furthermore, this approach lays the groundwork for developing a novel approach to causal assessment that begins with a rapid, screening-level evaluation of stressors common in a region using these data-rich groups of comparator sites, which then informs follow-up management actions.

Feasibility of Acupuncture to Induce Sleep for Brainstem Auditory Evoked Response Testing.

Purpose Brainstem auditory evoked response (BAER) testing is often performed under general anesthesia for children unable to complete behavioral audiologic evaluation. Alternatively, acupuncture treatment may be considered appropriate for BAER. Reports of acupuncture treatment in pediatric patients are scarce but are needed to demonstrate effectiveness. This study had 2 main objectives: (a) to examine the feasibility and effectiveness of acupuncture to achieve sleep to perform diagnostic BAER testing in medically complex (Cohort I) and nonmedically complex (Cohort II) children and (b) to assess acceptability to parents and audiologists of acupuncture as an alternative to anesthesia for BAER testing. Method A prospective feasibility study at Seattle Children's Hospital Outpatient Audiology Clinic from August 2015 through December 2018 was performed. A total of 31 pediatric patients were included. The median age for Cohort I was 29 months (interquartile range: 19-37 months), and the median age for Cohort II was 25.5 months (interquartile range: 16-32 months). Variables included number of BAER thresholds obtained, sleep indicators, and acceptability. The cost of BAER with acupuncture and the cost of BAER under anesthesia were compared. Results Acupuncture treatment effectively contributed to an adequate sleep state to obtain BAER results for most patients in both cohorts. Across cohorts, most patients (81%) fell asleep after acupuncture treatment. Complete test results were obtained in 48% of patients. Audiologists and parents reported high satisfaction rates with this procedure (87%). There were no adverse safety effects. Acupuncture treatment was less costly than anesthesia for BAER testing. Conclusions Acupuncture to induce sleep for BAER testing is effective, safe, and cost-efficient in small samples of medically and nonmedically complex pediatric patients. This procedure allowed earlier detection of hearing status and avoided potential adverse effects of anesthesia. Audiologists and parents reported that acupuncture treatment was an acceptable alternative to anesthesia for the BAER procedure.

Comparison of MRI in pediatric cochlear implant recipients with and without retained magnet.

OBJECTIVE: To report and compare medical, radiological, and audiological outcomes in pediatric cochlear implant recipients who underwent 1.5 and 3 Tesla strength MRI with and without retained magnet. METHODS: Retrospective chart review at a tertiary care pediatric hospital and review of literature. Patients were identified via electronic medical records database search and were included if they had MRI after cochlear implant. RESULTS: Of twelve instances of MRI in pediatric cochlear implant recipients at our institution, two minor complications and one major complication were recorded. The rate of complication was equal between patients who underwent MRI with and without retained magnet. All minor complications resulted from MRI with retained magnet whereas the only major complication resulted from magnet removal. Two novel complications are reported, including: magnet removal resulting in silastic tear necessitating reimplantation and magnet dislocation with spontaneous reduction. Magnet removal significantly decreased the size of artifact, but did not alter the diagnostic utility of the MRI. While audiological measures varied chronologically from MRI scans, they did not appear to be appreciably altered by MRI. CONCLUSION: MRI with and without magnet retention appear to carry risks of both major and minor complications. For the regions of interest for each scan, MRI quality was not appreciably altered by magnet status. Audiological measures appear unaffected by magnet status during MRI however, this may reflect natural variation.

A designed experiment for evaluation of the OPA method for cleaning studies of medical devices.

This study reports the results of a designed experiment to evaluate the use of the o-phthalic dialdehyde (OPA) method for residual protein, with a testsoilderivedfrom blood, dehydrated hog mucin, and egg yolk, and its application in validating the automated cleaning of surgical instruments in a laboratory setting. The ruggedness and robustness of the OPA method was determined by means of a Plackett-Burman experimental design and assessed the automated cleaning of a microkeratome for use in patients undergoing lamellar resection of the cornea during refractive surgery. The outcome of the study indicates that the OPA method for residual protein is rugged and robust for the factors evaluated and is an effective means for validating the cleaning of complex medical devices under controlled laboratory conditions. The components of the microkeratome contaminated with the test soil were successfully cleaned in an automated washer-disinfector using a neutral pH detergent and the procedure as described.

Response of chlorophyll a to total nitrogen and total phosphorus concentrations in lotic ecosystems: a systematic review protocol.

BACKGROUND: Eutrophication of freshwater ecosystems resulting from nitrogen and phosphorus pollution is a major stressor across the globe. Despite recognition by scientists and stakeholders of the problems of nutrient pollution, rigorous synthesis of scientific evidence is still needed to inform nutrient-related management decisions, especially in streams and rivers. Nutrient stressor-response relationships are complicated by multiple interacting environmental factors, complex and indirect causal pathways involving diverse biotic assemblages and food web compartments, legacy (historic) nutrient sources such as agricultural sediments, and the naturally high spatiotemporal variabilityof lotic ecosystems. Determining nutrient levels at which ecosystems are affected is a critical first step for identifying, managing, and restoring aquatic resources impaired by eutrophication and maintaining currently unimpaired resources. The systematic review outlined in this protocol will compile and synthesize literature on the response of chlorophyll a to nutrients in streams, providing a state-of-the-science body of evidence to assess nutrient impacts to one of the most widely-used measures of eutrophication. This review will address two questions: "What is the response of chlorophyll a to total nitrogen and total phosphorus concentrations in lotic ecosystems?" and "How are these relationships affected by other factors?" METHODS: Searches for published and unpublished articles (peer-reviewed and non-peer-reviewed) will be conducted using bibliographic databases and search engines. Searches will be supplemented with bibliography searches and requests for material from the scientific and management community. Articles will be screened for relevance at the title/abstract and full text levels using pre-determined inclusion criteria; 10% (minimum 50, maximum 200) of screened papers will be examined by multiple reviewers to ensure consistent application of criteria. Study risk of bias will be evaluated using a questionnaire developed from existing frameworks and tailored to the specific study types this review will encounter. Results will be synthesized using meta-analysis of correlation coefficients, as well as narrative and tabular summaries, and will focus on the shape, direction, strength, and variability of available nutrient-chlorophyll relationships. Sensitivity analysis and meta-regression will be used to evaluate potential effects of study quality and modifying factors on nutrient-chlorophyll relationships.

Cochlear Implantation in Children with Postlingual Progressive Steeply Sloping High-Frequency Hearing Loss.

BACKGROUND: Children with steeply sloping sensorineural hearing loss (SNHL) lack access to critical high-frequency cues despite the use of advanced hearing aid technology. In addition, their auditory-only aided speech perception abilities often meet Food and Drug Administration criteria for cochlear implantation. PURPOSE: The objective of this study was to describe hearing preservation and speech perception outcomes in a group of young children with steeply sloping SNHL who received a cochlear implant (CI). RESEARCH DESIGN: Retrospective case series. STUDY SAMPLE: Eight children with steeply sloping postlingual progressive SNHL who received a unilateral traditional CI at Seattle Children's Hospital between 2009 and 2013 and had follow-up data available up to 24 mo postimplant were included. DATA COLLECTION AND ANALYSIS: A retrospective chart review was completed. Medical records were reviewed for demographic information, preoperative and postoperative behavioral hearing thresholds, and speech perception scores. Paired t tests were used to analyze speech perception data. Hearing preservation results are reported. RESULTS: Rapid improvement of speech perception scores was observed within the first month postimplant for all participants. Mean monosyllabic word scores were 76% and mean phoneme scores were 86.7% at 1-mo postactivation compared to mean preimplant scores of 19.5% and 31.0%, respectively. Hearing preservation was observed in five participants out to 24-mo postactivation. Two participants lost hearing in both the implanted and unimplanted ear, and received a sequential bilateral CI in the other ear after progression of the hearing loss. One participant had a total loss of hearing in only the implanted ear. Results reported in this article are from the ear implanted first. Bilateral outcomes are not reported. CONCLUSIONS: CIs provided benefit for children with steeply sloping bilateral hearing loss for whom hearing aids did not provide adequate auditory access. In our cohort, significant improvements in speech understanding occurred rapidly postactivation. Preservation of residual hearing in children with a traditional CI electrode is possible.