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American Cochlear Implant Alliance Task Force Guidelines for Determining Cochlear Implant Candidacy in Children.

ABSTRACT: This article summarizes the available evidence on pediatric cochlear implantation to provide current guidelines for clinical protocols and candidacy recommendations in the United States. Candidacy determination involves specification of audiologic and medical criteria per guidelines of the Food and Drug Administration. However, recommendations for a cochlear implant evaluation also should maintain flexibility and consider a child's skill progression (i.e., month-for-month progress in speech, language, and auditory development) and quality of life with appropriately fit hearing aids. Moreover, evidence supports medical and clinical decisions based on other factors, including (a) ear-specific performance, which affords inclusion of children with asymmetric hearing loss and single-sided deafness as implant candidates; (b) ear-specific residual hearing, which influences surgical technique and device selection to optimize hearing; and (c) early intervention to minimize negative long-term effects on communication and quality of life related to delayed identification of implant candidacy, later age at implantation, and/or limited commitment to an audiologic rehabilitation program. These evidence-based guidelines for current clinical protocols in determining pediatric cochlear implant candidacy encourage a team-based approach focused on the whole child and the family system.

SUBMITTER: Warner-Czyz AD

PROVIDER: S-EPMC8862774 | biostudies-literature | 2022 Mar/Apr

REPOSITORIES: biostudies-literature

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American Cochlear Implant Alliance Task Force Guidelines for Determining Cochlear Implant Candidacy in Children.

Warner-Czyz Andrea D AD Roland J Thomas JT Thomas Denise D Uhler Kristin K Zombek Lindsay L

Ear and hearing 20220301 2

This article summarizes the available evidence on pediatric cochlear implantation to provide current guidelines for clinical protocols and candidacy recommendations in the United States. Candidacy determination involves specification of audiologic and medical criteria per guidelines of the Food and Drug Administration. However, recommendations for a cochlear implant evaluation also should maintain flexibility and consider a child's skill progression (i.e., month-for-month progress in speech, lan ...[more]

PMID: 35213891

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Project description:HYPOTHESIS:Clinical adult cochlear implant (CI) candidacy evaluations rely heavily on measures of sentence recognition under the best-aided listening conditions. The hypothesis tested in this study was that nonauditory measures of neurocognitive processes would contribute to scores on preoperative sentence recognition for CI candidates, above and beyond hearing ability as assessed using pure-tone average (PTA). Support for this hypothesis would suggest that best-aided sentence recognition is not simply a measure of hearing ability; rather, neurocognitive functions contribute to performance and should be considered while counseling patients during CI candidacy evaluation about postoperative rehabilitative and outcome expectations. BACKGROUND:Neurocognitive functions, such as working memory capacity, inhibition-concentration, information processing speed, and nonverbal reasoning contribute to aided speech recognition outcomes in adults with hearing loss. This study examined the roles of these neurocognitive factors on preoperative speech recognition performance in adults evaluated for CI candidacy. METHODS:Thirty-one postlingually deafened adult CI candidates were enrolled. Participants were assessed using nonauditory measures of working memory capacity, inhibition-concentration, information processing speed, and nonverbal reasoning. Measures of sentence recognition in quiet and in multitalker babble (AzBio sentences) as well as sentences from the City University of New York in quiet were collected under best-aided conditions. RESULTS:AzBio sentence recognition scores in babble were predicted significantly by scores of working memory capacity after accounting for PTA. Similarly, the City University of New York sentence recognition scores were predicted significantly by nonverbal reasoning after accounting for PTA. CONCLUSIONS:Findings support the idea that clinical measures of sentence recognition may be affected to varying degrees by neurocognitive functions, and these functions should be considered during evaluation for CI candidacy.

Project description:IntroductionOnly a small percentage (6-10%) of patients who are candidates receive cochlear implants (CIs). One potential reason contributing to low usage rates may be confusion regarding which patients to refer for CI evaluation. The extent to which information provided by standard clinical audiologic assessments is sufficient for selecting appropriate CI evaluation referrals is uncertain. The objective of this study is to evaluate the capacity of standard clinical audiologic measures to differentiate CI candidates from noncandidates.MethodThe study design is a retrospective review of a prospectively maintained CI database from a university-based tertiary medical center of 518 patients undergoing CI evaluations from 2012 to 2020. Each ear of each patient was treated as an independent value. Receiver operating characteristic (ROCs) curves were constructed using aided AzBio sentence recognition scores in quiet and aided AzBio +10 dB signal-to-noise ratio scores <60% as binary classifiers for CI candidacy. For each ROC, we examined the capacity of multiple pure-tone thresholds, pure-tone average (PTA), and CNC word recognition scores (WRSs) measured under earphones to determine CI candidacy. Area under the curve ROC (AUC-ROC) values were calculated to demonstrate the capacity of each model to differentiate CI candidates from noncandidates.ResultsVariables with the greatest capacity to accurately differentiate CI candidates from noncandidates using aided AzBio in quiet scores were earphone CNC WRS, earphone pure-tone threshold at 1,000 Hz, and earphone PTA (AUC-ROC values = 0.86-0.88). Using aided AzBio +10 scores as the measure for candidacy, only CNC word recognition had a fair capacity to identify candidates (AUC-ROC value = 0.73). Based on the ROCs, a 1,000 Hz pure-tone threshold >50 dB HL, PTA >57 dB HL, and a monosyllabic WRS <60% can each serve as individual indicators for referral for CI evaluations.ConclusionThe current study provides initial indicators for referral and a first step at developing evidence-based criteria for CI evaluation referral using standard audiologic assessments.

Project description:BackgroundCochlear implantation in children with sensorineural hearing loss is preferably performed at youngest age because early auditory input is essential to prevent neural plasticity decline. In contrast, the rate of anesthetic adverse events is increased during infancy. Therefore, to provide recommendations regarding an optimal pediatric implantation age, these possible anesthetic risks in infants need to be taken into account.AimsThis study aimed at assessing the relation between the age at cochlear implant surgery and anesthetic and surgical adverse events. Secondary aims were to evaluate anesthetic and surgical adverse events in relation to (a) the number of preoperative anesthesia-related procedures for cochlear implant candidacy assessment and (b) the anesthetic maintenance agent (total intravenous anesthesia versus inhalation anesthesia) during implantation.MethodsWe executed a retrospective cohort study to evaluate cochlear implantation performed in infants and toddlers between January 2008 and July 2015 in a tertiary pediatric center. We compared anesthetic and surgical adverse events between age-at-implantation (0-12 and 12-24 months of age) groups. Furthermore, we assessed whether anesthetic adverse events occurred during preoperative anesthesia-related procedures for cochlear implant candidacy assessment.ResultsForty-six cochlear implantations were performed in 43 patients requiring 42 preoperative anesthesia-related procedures. Nineteen cochlear implantations (41.3%) were performed during infancy. During implantation, the maintenance agent was either sevoflurane (n = 22) or propofol (n = 24). None of the patients encountered major anesthetic adverse events, whereas minor adverse events occurred during 34 cochlear implantations. Those attributed to surgery occurred following six implantations. Neither the age at implantation nor the anesthetic maintenance agent was significantly related to the occurrence of both types of adverse events.ConclusionsAdverse events occur independent of the age at implantation, the number of anesthetic preoperative procedures, and the type of anesthetic maintenance agent in patients who received a cochlear implant before 24 months of age.

Project description:BackgroundA number of recent advances in our understanding of thyroid physiology may shed light on why some patients feel unwell while taking levothyroxine monotherapy. The purpose of this task force was to review the goals of levothyroxine therapy, the optimal prescription of conventional levothyroxine therapy, the sources of dissatisfaction with levothyroxine therapy, the evidence on treatment alternatives, and the relevant knowledge gaps. We wished to determine whether there are sufficient new data generated by well-designed studies to provide reason to pursue such therapies and change the current standard of care. This document is intended to inform clinical decision-making on thyroid hormone replacement therapy; it is not a replacement for individualized clinical judgment.MethodsTask force members identified 24 questions relevant to the treatment of hypothyroidism. The clinical literature relating to each question was then reviewed. Clinical reviews were supplemented, when relevant, with related mechanistic and bench research literature reviews, performed by our team of translational scientists. Ethics reviews were provided, when relevant, by a bioethicist. The responses to questions were formatted, when possible, in the form of a formal clinical recommendation statement. When responses were not suitable for a formal clinical recommendation, a summary response statement without a formal clinical recommendation was developed. For clinical recommendations, the supporting evidence was appraised, and the strength of each clinical recommendation was assessed, using the American College of Physicians system. The final document was organized so that each topic is introduced with a question, followed by a formal clinical recommendation. Stakeholder input was received at a national meeting, with some subsequent refinement of the clinical questions addressed in the document. Consensus was achieved for all recommendations by the task force.ResultsWe reviewed the following therapeutic categories: (i) levothyroxine therapy, (ii) non-levothyroxine-based thyroid hormone therapies, and (iii) use of thyroid hormone analogs. The second category included thyroid extracts, synthetic combination therapy, triiodothyronine therapy, and compounded thyroid hormones.ConclusionsWe concluded that levothyroxine should remain the standard of care for treating hypothyroidism. We found no consistently strong evidence for the superiority of alternative preparations (e.g., levothyroxine-liothyronine combination therapy, or thyroid extract therapy, or others) over monotherapy with levothyroxine, in improving health outcomes. Some examples of future research needs include the development of superior biomarkers of euthyroidism to supplement thyrotropin measurements, mechanistic research on serum triiodothyronine levels (including effects of age and disease status, relationship with tissue concentrations, as well as potential therapeutic targeting), and long-term outcome clinical trials testing combination therapy or thyroid extracts (including subgroup effects). Additional research is also needed to develop thyroid hormone analogs with a favorable benefit to risk profile.

Project description:BackgroundThyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer.MethodsThe specific clinical questions addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of task force members. Task force panel members were educated on knowledge synthesis methods, including electronic database searching, review and selection of relevant citations, and critical appraisal of selected studies. Published English language articles on adults were eligible for inclusion. The American College of Physicians Guideline Grading System was used for critical appraisal of evidence and grading strength of recommendations for therapeutic interventions. We developed a similarly formatted system to appraise the quality of such studies and resultant recommendations. The guideline panel had complete editorial independence from the ATA. Competing interests of guideline task force members were regularly updated, managed, and communicated to the ATA and task force members.ResultsThe revised guidelines for the management of thyroid nodules include recommendations regarding initial evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy, interpretation of fine-needle aspiration biopsy results, use of molecular markers, and management of benign thyroid nodules. Recommendations regarding the initial management of thyroid cancer include those relating to screening for thyroid cancer, staging and risk assessment, surgical management, radioiodine remnant ablation and therapy, and thyrotropin suppression therapy using levothyroxine. Recommendations related to long-term management of differentiated thyroid cancer include those related to surveillance for recurrent disease using imaging and serum thyroglobulin, thyroid hormone therapy, management of recurrent and metastatic disease, consideration for clinical trials and targeted therapy, as well as directions for future research.ConclusionsWe have developed evidence-based recommendations to inform clinical decision-making in the management of thyroid nodules and differentiated thyroid cancer. They represent, in our opinion, contemporary optimal care for patients with these disorders.

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American Cochlear Implant Alliance Task Force Guidelines for Determining Cochlear Implant Candidacy in Children.

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American Cochlear Implant Alliance Task Force Guidelines for Determining Cochlear Implant Candidacy in Children.

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