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Biomedical subjects

Peter S Roland

Publications and source records attributed to Peter S Roland.

At least 19 recordsLinked to original sources

Clinical practice guideline: acute otitis externa.

OBJECTIVE: This guideline provides evidence-based recommendations to manage diffuse acute otitis externa (AOE), defined as generalized inflammation of the external ear canal, which may also involve the pinna or tympanic membrane. The primary purpose is to promote appropriate use of oral and topical antimicrobials and to highlight the need for adequate pain relief. STUDY DESIGN: In creating this guideline, the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) selected a development group representing the fields of otolaryngology-head and neck surgery, pediatrics, family medicine, infectious disease, internal medicine, emergency medicine, and medical informatics. The guideline was created with the use of an explicit, a priori, evidence-based protocol. RESULTS: The group made a strong recommendation that management of AOE should include an assessment of pain, and the clinician should recommend analgesic treatment based on the severity of pain. The group made recommendations that clinicians should: 1) distinguish diffuse AOE from other causes of otalgia, otorrhea, and inflammation of the ear canal; 2) assess the patient with diffuse AOE for factors that modify management (nonintact tympanic membrane, tympanostomy tube, diabetes, immunocompromised state, prior radiotherapy); and 3) use topical preparations for initial therapy of diffuse, uncomplicated AOE; systemic antimicrobial therapy should not be used unless there is extension outside of the ear canal or the presence of specific host factors that would indicate a need for systemic therapy. The group made additional recommendations that: 4) the choice of topical antimicrobial therapy of diffuse AOE should be based on efficacy, low incidence of adverse events, likelihood of adherence to therapy, and cost; 5) clinicians should inform patients how to administer topical drops, and when the ear canal is obstructed, delivery of topical preparations should be enhanced by aural toilet, placing a wick, or both; 6) when the patient has a tympanostomy tube or known perforation of the tympanic membrane, the clinician should prescribe a nonototoxic topical preparation; and 7) if the patient fails to respond to the initial therapeutic option within 48 to 72 hours, the clinician should reassess the patient to confirm the diagnosis of diffuse AOE and to exclude other causes of illness. And finally, the panel compiled a list of research needs based on limitations of the evidence reviewed. CONCLUSION: This clinical practice guideline is not intended as a sole source of guidance in evaluating patients with AOE. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to the diagnosis and management of this problem. SIGNIFICANCE: This is the first, explicit, evidence-based clinical practice guideline on acute otitis externa, and the first clinical practice guideline produced independently by the AAO-HNSF.

Acute Disease↗

Silicone allergy: A new cause for cochlear implant extrusion and its management.

OBJECTIVE: We introduce silicone allergy as a rare cause for cochlear implant extrusion and discuss its management. STUDY DESIGN: Retrospective case series and literature review. SETTING: Tertiary referral centers. PATIENTS: Primary eligibility criteria included patients who experienced a delayed extrusion of their cochlear implants with negative wound cultures and had a suspected or a test-proven allergy to silicone components of an implant. INTERVENTIONS: Silicone allergy testing, explantation of a cochlear implant containing allergenic silicone materials, reimplantation with a custom-made cochlear implant excluding an allergenic silicone component. OUTCOME MEASURES: Uneventful wound healing and extrusion-free long-term follow-up after the reimplantation with a custom-made cochlear implant excluding an allergenic silicone component. RESULTS: Three known cases of cochlear implant extrusion as a result of silicone allergy have been noted from 1991 through 2004 in three cochlear implant programs in the United States. All three devices extruded, resulting in explantation of the old device and reimplantation with a new custom-made device eliminating the allergenic silicone component. Wound cultures were negative in all cases. All three patients experienced a delayed extrusion of their devices. Two of these patients had a test-proven allergy to the implant's silicone components, whereas the third patient was presumed to have a hypersensitivity solely on the basis of a clinical presentation. CONCLUSION: We propose that silicone allergy is a rare cause of cochlear implant extrusion. Patients experiencing cochlear implant extrusion, particularly with a delayed onset and negative wound culture results, should be tested for silicone allergy.

Child, Preschool↗

Surgical aspects of cochlear implantation: mechanisms of insertional trauma.

The development of hybrid electroacoustic devices has made conservation of residual hearing an important goal in cochlear implant surgery. Our laboratory has recently conducted anatomical studies directed toward better understanding mechanisms underlying loss of residual hearing associated with electrode insertion. This paper provides an overview of observations based on microdissection, scanning electron microscopy and temporal bone histology relating to inner ear injury that may occur during implant surgery. Trauma to cochlear structures including lateral wall tissues, the basilar membrane, the osseous spiral lamina and the modiolus is considered in relation to the implications of specific types of injury for hearing preservation. These findings are relevant to the design of future implant devices and to various important issues regarding the surgical technique used for implantation, including the possible use of the round window as a portal of entry for electrode insertion.

Cochlea↗

Vertigo and motion sickness. Part II: Pharmacologic treatment.

Vertigo is a sensation of movement when no movement is actually occurring. It is often accompanied by visceral autonomic symptoms including pallor, diaphoresis, nausea, and vomiting. Vertigo is similar to motion sickness in that both may be caused by vestibular stimulation that does not match an internal model of expected environmental stimuli. Indeed, a functioning vestibular system is necessary for the perception of motion sickness. For this reason, many of the same drugs are used to treat both conditions. The investigation of drugs that treat motion sickness helps to discover medications that may treat vertigo caused by disease of the vestibular system. In this article, we discuss the pharmacologic agents that are now available for the treatment of vertigo and those agents that are still under study.

Animals↗

Temporal bone histopathologic findings in partial trisomy 13 and partial trisomy 14.

OBJECTIVE: To describe temporal bone histopathology in an infant with partial trisomies of chromosomes 13 and 14. METHODS: Temporal bones were taken at autopsy from a 7-day-old neonate who has both partial trisomy 13 and partial trisomy 14. The right temporal bone was embedded in celloidin and sections were cut for microscopic examination. The left temporal bone was studied by microdissection. The middle ear was examined and the inner ear sensory organs dissected for study by light microscopy. RESULTS: The external auditory canal was stenotic in both ears. Remnants of mesenchymal tissue were present in the middle ear cavity. The middle ear ossicles were normal except that both stapes were malformed with a single crus and a small footplate. Both facial nerve canals were dehiscent in the region of the oval window. The cochlea was malformed bilaterally; a scala communis was present and the basilar membrane was abnormally short. No loss of sensory cells was observed in either cochlea. Blood vessels were found traversing scala vestibuli and there were cystic lesions in the stria vascularis and spiral ligament. In the middle cochlear turn, the bony wall of scala vestibuli and the osseous spiral lamina were covered by a substantial layer of connective tissue which appeared to be an extension of the spiral ligament. This is an unusual finding which, to the authors' knowledge, has not been previously reported. In the vestibular apparatus a wide communication was present between the saccule and utricle. CONCLUSIONS: As this study demonstrates, abnormalities of the external, middle, and inner ear may occur in cases of partial trisomy 13 and partial trisomy 14. Both temporal bone findings and clinical features in partial trisomy 13 and partial trisomy 14 to some degree overlap with those of trisomy 13, partial trisomy 13 and partial trisomy 14.

Chromosomes, Human, Pair 13↗

Spectrum of middle and inner ear abnormalities in infants with congenital heart defects.

OBJECTIVE: To evaluate temporal bone histopathology in infants with congenital heart defects (CHD). STUDY DESIGN AND SETTING: A retrospective review of our temporal bone collection was conducted to identify temporal bones acquired from infants with CHD. Subjects were divided into nonsyndromic and syndromic CHD groups. The presence of temporal bone abnormalities and the incidence of abnormalities that may result in hearing impairment were determined. RESULTS: Thirty-eight temporal bones obtained from 16 infants with nonsyndromic CHD and 4 with syndromic CHD were evaluated. Nonsyndromic CHD cases had abnormalities such as a mesenchymal remnant, malformed stapes, persistent stapedial artery, shallow round window, dehiscent facial nerve canal, short cochlea, strial basophilic deposits, deformity of the spiral ligament, bulging Reissner's membrane, hypoplastic lateral semicircular canal, and cupular deposits. Syndromic CHD cases had abnormalities including narrow round window niche, facial canal dehiscence, strial basophilic deposits and cysts, and outer hair cell loss. Middle and inner ear abnormalities that may impair hearing were observed in 6 subjects with nonsyndromic CHD and in 1 subject with syndromic CHD. CONCLUSIONS: A wide variety of temporal bone defects were documented in infants with CHD. Congenital middle and inner ear abnormalities should be anticipated in the hearing assessment and otologic surgery of infants with CHD.

Abnormalities, Multiple↗

Microbiology of acute otitis media with tympanostomy tubes.

OBJECTIVE: The objective was to determine the types of organisms which cause acute otitis media with a tympanostomy tube and to ascertain their frequency distribution. STUDY DESIGN AND SETTING: Prospective, randomized, multi-institutional clinical trials. Both private and academic sites were included. RESULTS: 1309 isolates were recovered from 956 draining ears. Streptococcus pneumonia was recovered from 17%, Staphylococcus aureus from 13%, H flu from 18% and Pseudomonas aeruginosa from 12%. Fungal organisms were recovered from 5% of total isolates and 4% from single isolates. CONCLUSIONS: AOMT is microbiologically different than AOM with an intact TM. There is no evidence that resistance develops as result of topical treatment. SIGNIFICANCE: The study demonstrates that AOMT is frequently caused by organisms not susceptible to oral antibiotics approved for children, but which are sensitive to topical ear drops.

Acute Disease↗

Optimal duration of allergic rhinitis clinical trials.

OBJECTIVE: Guidelines have been published by the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) for the conduct of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) studies. These guidelines have differences regarding the duration of such trials: the FDA suggests 2 weeks for SAR and 4 weeks for PAR but the EMEA suggests 2 to 4 weeks for SAR and 6 to 12 weeks for PAR trials. In the interest of global harmonization, it would be desirable to have a uniform duration of such trials so that investigators, internationally, would be able to readily compare results for various types of treatments based on a single standard. Therefore, we performed an evidence-based review to answer the clinical question, What is the optimal duration for SAR and PAR clinical trials? METHODS: We performed a MEDLINE search of the published literature from 1995 to the present. We used appropriate search terms, such as allergic rhinitis, seasonal allergic rhinitis, perennial allergic rhinitis, SAR, and PAR, to identify pertinent articles. These articles were reviewed and graded according to the evidence quality. RESULTS: After an initial screening of more than 300 articles, 138 articles were analyzed thoroughly. No study specifically addressed the question of the optimal duration of SAR or PAR clinical trials. CONCLUSIONS: We conclude that the current FDA (draft) guidelines calling for a study length of 2 weeks for the assessment of drug efficacy for SAR and 4 weeks for the study of drug efficacy in PAR are appropriate and that longer study periods are not likely to add meaningfully to the assessment of drug efficacy.

Clinical Trials as Topic↗

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis.

BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR). OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo in patients with SAR. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 565 patients aged 12 to 80 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms and completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: Olopatadine spray (0.4% and 0.6%) was significantly superior to placebo for percentage change from baseline in overall reflective (P = .004 and P < .001, respectively) and instantaneous (P = .02 and P = .003, respectively) TNSSs. Also, 0.6% olopatadine was significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny and itchy nose, and itchy eyes; the instantaneous assessments of watery eyes; and the overall and all 7 domain scores of the RQLQ (P < .05). Olopatadine spray exhibited a safety profile comparable with that of placebo. CONCLUSIONS: Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs (reflective and instantaneous) and in quality-of-life variables in patients with SAR. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Administration, Intranasal↗

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar.

BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar. OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms. RESULTS: Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. Olopatadine spray exhibited a safety profile comparable with that of placebo. CONCLUSIONS: Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Administration, Inhalation↗

Bacterial biofilm formation on a human cochlear implant.

OBJECTIVE: To report the characteristics of a bacterial biofilm from the surface of a cochlear implant. BACKGROUND: Bacterial biofilm formation on implanted devices causes intractable infections and device extrusions necessitating device removal, with loss of function. More information is needed about biofilm characteristics and interactions with the implant surface before better treatments can be designed. STUDY DESIGN: A retrospective case review was combined with a descriptive histological study of the surface of an otologic device. METHODS: The receiver/stimulator device removed from a cochlear implant patient because of intractable infection and partial device extrusion was fixed and processed for microscopic examination. Its surface and the material present on its surface were analyzed using light and electron microscopy, focusing on surface texture, cell types, and bacteria species and extracellular polymeric substances present within the biofilm. RESULTS: Stereomicroscopic examination revealed extracellular polymeric substances, pinkish yellow in color, with spheres of uniform size scattered throughout, indicative of a biofilm containing Staphylococcus aureus. Biofilm density was greatest in depressions on the surface of the implant. Cross-sectional analysis revealed bacteria interspersed with polymorphonuclear leukocytes. Scanning electron microscopic examination demonstrated an amorphous layer of extracellular polymeric substances containing small filaments, bacteria, and inflammatory cells. Only Staphylococcus aureus was detected. CONCLUSION: Cochlear implant material can provide a surface for bacterial biofilm formation. Impressions can provide an environment conducive to biofilm establishment and growth, ultimately necessitating device removal, with loss of implant function. Biofilm characterization should aid in design of cochlear implant devices less susceptible to biofilm formation.

Anti-Bacterial Agents↗

Advantages of magnetic resonance imaging over computed tomography in preoperative evaluation of pediatric cochlear implant candidates.

OBJECTIVES: To compare magnetic resonance imaging (MRI) to high-resolution computed tomography (HRCT) in the preoperative evaluation of pediatric cochlear implant candidates. METHODS: The charts of pediatric cochlear implant candidates evaluated between July 1, 2000 and November 30, 2003 with an MRI scan of the inner ear were included in the study. Fifty-six patients were included. Associated HRCT scans were examined. Abnormalities of the cochlea, cochlear nerve, endolymphatic sac, endolymphatic duct, vestibule, and modiolus were noted. A pediatric neuroradiologist gave an opinion as to whether patients with anomalies seen with MRI but without associated HRCT would have been identified by HRCT. RESULTS: Of the 112 temporal bones imaged with MRI, the following abnormalities were encountered: 32% (36/112) had abnormalities of the cochlear turns, 30% (34/112) had abnormal signal in the modiolus, 23% (26/112) had abnormal vestibulae, 16% (18/112) had abnormal endolymphatic ducts, 15% (17/112) had abnormal endolymphatic sacs, 12% (13/112) had abnormalities of the cochlear nerves, 29% (17/56) had abnormalities of the brain. HRCT cannot directly evaluate the cochlear nerve. Available HRCT findings were combined with radiologic opinion and compared with MRI findings. The percentages of abnormalities identifiable by HRCT when compared with those seen with MRI are cochlea 42% (15/36), modiolus 35% (12/34), vestibulae 88% (23/26), endolymphatic duct 100% (18/18), and endolymphatic sac 6% (1/17). CONCLUSION: MRI is more sensitive and specific in diagnosing soft tissue abnormalities in the inner ear than HRCT in cochlear implant candidates (Fig. 4). Moreover, the abnormalities detected with MRI are more likely to influence the implantation process (e.g., asymmetric nerve aplasia, cochlear obstruction). (Figure is included in full-text article).

Child↗

Cytomegalovirus in the perilymphatic fluid.

OBJECTIVE: The incidence of congenital cytomegalovirus (CMV) infection is approximately 1% of neonates. Ninety percent of congenitally infected infants are "asymptomatic;" they have no signs or symptoms at birth. The prevalence of congenital CMV in the profoundly deaf population and the pathogenesis of deafness from CMV are unknown. The objective of this study is to determine whether CMV can be demonstrated and quantified in perilymphatic fluid of patients with congenital CMV infection and sensorineural hearing loss (SNHL) using a quantitative real-time polymerase chain reaction (QRTPCR). STUDY DESIGN: Prospective case series. METHODS: Perilymphatic fluid was collected at the time of cochlear implantation from children with known or radiologic evidence of congenital CMV infection and analyzed for the presence of CMV using QRTPCR. Blood was collected and analyzed for CMV using QRTPCR, serology, and culture. CMV was quantified in perilymphatic fluid and compared with that present in the patient's blood. RESULTS: Perilymphatic fluid and blood was collected from six children. QRTPCR was positive for CMV in the perilymphatic fluid of four patients. Blood analyzed with QRTPCR, and culture was negative in all patients. CONCLUSIONS: CMV can be demonstrated and quantified in perilymphatic fluid using QRTPCR. Refinements in our technique and sampling of perilymphatic fluid from a large population of children with congenital SNHL and unknown etiology can determine the prevalence of CMV-mediated profound HL.

Child, Preschool↗

Advanced bionics thin lateral and Helix II electrodes: a temporal bone study.

OBJECTIVE: This study was performed to evaluate the insertional properties of two cochlear implant electrodes recently developed by Advanced Bionics Corporation. STUDY DESIGN: Anatomic study using human cadaveric temporal bones. METHODS: The electrode prototypes we tested are the Thin Lateral and Helix II arrays, which incorporate features designed to minimize insertional trauma. A total of eight electrodes (4 of each prototype) were evaluated after insertion into freshly fixed temporal bones. The electrodes were inserted by way of standard cochleostomies, and the specimens were subsequently dissected to assess electrode position, insertion depth, and intracochlear trauma. RESULTS: Quantitative data regarding insertion depths and contact distances from the modiolus are presented for all electrodes tested. The mean insertion depths were 368 degrees for the Thin Lateral electrodes, which are designed to approximate the lateral cochlear wall, and 436 degrees for the Helix II electrodes, which occupy a more medial position in the scala tympani. No evidence of insertional trauma was observed with either electrode. The ease of insertion and absence of trauma were confirmed during additional trials in which electrode behavior was directly observed during insertion into previously opened cochleas. CONCLUSION: Both electrodes performed favorably in our human temporal bone trials, and both arrays appear promising for clinical use, especially in patients with residual hearing in whom atraumatic insertion is an important objective.

Bionics↗

Acquired external auditory canal stenosis: assessment and management.

PURPOSE OF REVIEW: Although uncommon, acquired external auditory canal stenosis is an entity that is encountered by many otolaryngologists. This paper reviews the causes, pathogenesis, assessment, and management options for external auditory canal stenosis. RECENT FINDINGS: Initially, acquired external auditory canal stenosis was described as resulting from a number of different causes. Since then, histology and imaging studies of this disease have shown that a common cascade of inflammatory changes resulting from these different causes is the primary pathogenesis leading to medial canal fibrosis. Once there is complete obstruction of the external auditory canal, surgery is the primary treatment. Understanding the strong role of inflammation in the pathogenesis of external auditory canal stenosis may lead to new preventative medical therapies. SUMMARY: Although acquired external auditory canal was described several years ago, its underlying pathophysiology is now better understood. From this knowledge, improved medical as well as surgical approaches can be developed.

Constriction, Pathologic↗