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OBJECTIVES: Sensory methods use human senses to evaluate product attributes. This review provides an overview of the types of sensory methods used to evaluate the perception of flavour in tobacco and other nicotine-containing (ToNic) products and to discuss how sensory data could inform flavoured ToNic product policy. DATA SOURCES: PubMed, Embase and Web of Science. STUDY SELECTION: All peer-reviewed studies evaluating ToNic products using a sensory method published before 23 May 2020. DATA EXTRACTION: Two independent coders completed title/abstract and full-text screening to choose articles for inclusion (Cohen's kappa=0.85, strong agreement). Each coder completed data extraction on half the articles, recording relevant information (eg, sensory methods used, results). The coders categorised sensory methods and generated overarching themes. DATA SYNTHESIS: Of 110 articles identified, we included 29 articles containing 35 studies that used sensory methods to investigate ToNic products. The sensory methods included analytic methods such as discrimination and descriptive tests and hedonic methods such as liking tests. Six themes emerged regarding how sensory methods can be used to understand consumer perception and liking of ToNic products and to inform ToNic product policy. CONCLUSIONS: The identified studies highlight that sensory data can inform ToNic product policy. Analytic and sensory hedonic ratings can be used to assess a ToNic product's ability to promote addiction in the user (ie, abuse liability). Lastly, hedonic ratings can provide information to assess potential use behaviours.
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Sistemas Electrónicos de Liberación de Nicotina , Productos de Tabaco , Humanos , Nicotina , Nicotiana , Aromatizantes , PercepciónRESUMEN
BACKGROUND: Electronic nicotine delivery system (ENDS)-associated overheating, fire or explosion (OH/F/EXP) events have occurred since at least 2009. OBJECTIVE: To identify the number and nature of ENDS OH/F/EXP events in the USA. METHODS: Center for Tobacco Products (CTP) scientists searched for event reports among five US federal agencies, scientific literature and media outlets. FINDINGS: 100 reference sources identified 92 OH/F/EXP events in the USA, of which 45 (49%) injured 47 people, and 67 (73%) involved property damage beyond the product. Events were identified in media outlets (n=50; 54%) and reported to four agencies (n=42; 46%). The report rate peaked at an average of six reports per month in late 2013 with a smaller peak of three to four reports per month in the second quarter of 2015. All reports were incomplete and events exhibited variability. International events in three countries are mentioned, and international responses to events are summarised. CONCLUSIONS: The scope, causes and trajectory of ENDS OH/F/EXP events remain incompletely defined. Some events have resulted in life-threatening injury, permanent disfigurement or disability, and major property damage, suggesting the need for ongoing surveillance and risk mitigation. More comprehensive reporting could assist future analyses and may help to identify root causes and contributors to the OH/F/EXP events.
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No conventional therapy exists for salivary hypofunction in surviving head and neck cancer patients with Radiation Therapy Oncology Group late grade 2-3 toxicity. We conducted a phase I clinical trial to test the safety and biologic efficacy of serotype 5, adenoviral-mediated aquaporin-1 cDNA transfer to a single previously irradiated parotid gland in 11 subjects using an open label, single-dose, dose-escalation design (AdhAQP1 vector; four dose tiers from 4.8 × 10(7) to 5.8 × 10(9) vector particles per gland). Treated subjects were followed at scheduled intervals. Multiple safety parameters were measured and biologic efficacy was evaluated with measurements of parotid salivary flow rate. Symptoms were assessed with a visual analog scale. All subjects tolerated vector delivery and study procedures well over the 42-d study period reported. No deaths, serious adverse events, or dose-limiting toxicities occurred. Generally, few adverse events occurred, and all were considered mild or moderate. No consistent changes were found in any clinical chemistry and hematology parameters measured. Objective responses were seen in six subjects, all at doses <5.8 × 10(9) vector particles per gland. Five of these six subjects also experienced subjective improvement in xerostomia. AdhAQP1 vector delivery to a single parotid gland was safe and transfer of the hAQP1 cDNA increased parotid flow and relieved symptoms in a subset of subjects.
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Adenoviridae/genética , Acuaporina 1/genética , Acuaporina 1/uso terapéutico , ADN Complementario/genética , Terapia Genética , Traumatismos por Radiación/terapia , Enfermedades de las Glándulas Salivales/terapia , Anciano , Citratos , Galio , Terapia Genética/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Traumatismos por Radiación/diagnóstico por imagen , Traumatismos por Radiación/genética , Cintigrafía , Enfermedades de las Glándulas Salivales/diagnóstico por imagen , Enfermedades de las Glándulas Salivales/etiología , Enfermedades de las Glándulas Salivales/fisiopatologíaRESUMEN
OBJECTIVE: A systematic review was conducted to evaluate the impact of human factors (HF) on the risks associated with electronic cigarettes (e-cigarettes) and to identify research gaps. HF is the evaluation of human interactions with products and includes the analysis of user, environment and product complexity. Consideration of HF may mitigate known and potential hazards from the use and misuse of a consumer product, including e-cigarettes. METHODS: Five databases were searched through January 2014 and publications relevant to HF were incorporated. Voluntary adverse event (AE) reports submitted to the US Food and Drug Administration (FDA) and the package labelling of 12 e-cigarette products were analysed. RESULTS: No studies specifically addressing the impact of HF on e-cigarette use risks were identified. Most e-cigarette users are smokers, but data on the user population are inconsistent. No articles focused specifically on e-cigarette use environments, storage conditions, product operational requirements, product complexities, user errors or misuse. Twelve published studies analysed e-cigarette labelling and concluded that labelling was inadequate or misleading. FDA labelling analysis revealed similar concerns described in the literature. AE reports related to design concerns are increasing and fatalities related to accidental exposure and misuse have occurred; however, no publications evaluating the relationship between AEs and HF were identified. CONCLUSIONS: The HF impacting e-cigarette use and related hazards are inadequately characterised. Thorough analyses of user-product-environment interfaces, product complexities and AEs associated with typical and atypical use are needed to better incorporate HF engineering principles to inform and potentially reduce or mitigate the emerging hazards associated with e-cigarette products.
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Sistemas Electrónicos de Liberación de Nicotina/efectos adversos , Medición de Riesgo , Humanos , Etiquetado de ProductosRESUMEN
This is a companion paper to two previous publications on recommended practices for cleaning and reprocessing flexible endoscopes used in Otolaryngology (Burlingame, Arcilla, & McDermott, 2008; Adams & Baker, 2010). In this paper we capture and expand upon the audience question and answer session in which the Society of Otorhinolaryngology and Head-Neck Nurse (SOHN)--endorsed the Association of periOperative Registered Nurses (AORN) recommended practices were presented to the SOHN membership (Adams & Waddington, September, 2010). We include additional background information to assist readers in understanding some of the science behind the recommendations and share successful implementation strategies from Otorhinolaryngology (ORL) outpatient nurses and published references.
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Desinfección/normas , Endoscopios/microbiología , Contaminación de Equipos/prevención & control , Control de Infecciones/métodos , Otolaringología/instrumentación , Guías de Práctica Clínica como Asunto , Biopelículas , Equipo Reutilizado , Humanos , Enfermedades Otorrinolaringológicas/enfermería , Sociedades de EnfermeríaRESUMEN
Gene therapy of human cancer using genetically engineered lymphocytes is dependent on the identification of highly reactive T-cell receptors (TCRs) with antitumor activity. We immunized transgenic mice and also conducted high-throughput screening of human lymphocytes to generate TCRs highly reactive to melanoma/melanocyte antigens. Genes encoding these TCRs were engineered into retroviral vectors and used to transduce autologous peripheral lymphocytes administered to 36 patients with metastatic melanoma. Transduced patient lymphocytes were CD45RA(-) and CD45RO(+) after ex vivo expansion. After infusion, the persisting cells displayed a CD45RA(+) and CD45RO(-) phenotype. Gene-engineered cells persisted at high levels in the blood of all patients 1 month after treatment, responding patients with higher ex vivo antitumor reactivity than nonresponders. Objective cancer regressions were seen in 30% and 19% of patients who received the human or mouse TCR, respectively. However, patients exhibited destruction of normal melanocytes in the skin, eye, and ear, and sometimes required local steroid administration to treat uveitis and hearing loss. Thus, T cells expressing highly reactive TCRs mediate cancer regression in humans and target rare cognate-antigen-containing cells throughout the body, a finding with important implications for the gene therapy of cancer. This trial was registered at www.ClinicalTrials.gov as NCI-07-C-0174 and NCI-07-C-0175.
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Antígenos de Neoplasias/inmunología , Terapia Genética/métodos , Melanoma/terapia , Receptores de Antígenos de Linfocitos T/administración & dosificación , Traslado Adoptivo/efectos adversos , Traslado Adoptivo/métodos , Adulto , Animales , Autoantígenos/inmunología , Femenino , Vectores Genéticos , Pérdida Auditiva/etiología , Humanos , Transfusión de Linfocitos/efectos adversos , Transfusión de Linfocitos/métodos , Linfocitos/metabolismo , Masculino , Melanocitos/inmunología , Melanoma/complicaciones , Ratones , Ratones Transgénicos , Persona de Mediana Edad , Receptores de Antígenos de Linfocitos T/genética , Receptores de Antígenos de Linfocitos T/inmunología , Especificidad del Receptor de Antígeno de Linfocitos T , Transducción Genética , Trasplante Autólogo , Resultado del Tratamiento , Uveítis/etiologíaAsunto(s)
Sistemas Electrónicos de Liberación de Nicotina/efectos adversos , Agonistas Nicotínicos/efectos adversos , United States Food and Drug Administration , Adulto , Obstrucción de las Vías Aéreas/etiología , Obstrucción de las Vías Aéreas/mortalidad , Quemaduras/etiología , Preescolar , Sistemas Electrónicos de Liberación de Nicotina/mortalidad , Humanos , Lactante , Exposición por Inhalación/efectos adversos , Agonistas Nicotínicos/administración & dosificación , Agonistas Nicotínicos/envenenamiento , Factores de Riesgo , Contaminación por Humo de Tabaco/efectos adversos , Estados UnidosRESUMEN
Hearing experts and public health organizations have longstanding hearing safety concerns about personal handheld audio devices, which are growing in both number and popularity. This paper reviews the maximum sound levels of handheld compact disc players, MP3 players, and an iPod. It further reviews device factors that influence the sound levels produced by these audio devices and ways to reduce the risk to hearing during their use.
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Discos Compactos , Exposición a Riesgos Ambientales/efectos adversos , Música , Ruido/efectos adversos , Grabación en Cinta , Educación en Salud , Humanos , Internet , Rol de la Enfermera , Salud Pública , SeguridadRESUMEN
Tobacco cessation intervention is a primary therapy for treating many conditions encountered in an otolaryngology practice. This paper presents the latest billing, coding, and insurance information to use in providing tobacco cessation services. It further guides the appropriate applications of these codes to patient encounters.
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Control de Formularios y Registros , Cobertura del Seguro , Cese del Uso de Tabaco , Tabla de Aranceles , HumanosRESUMEN
PURPOSE: To examine the effects the proteasome inhibitor bortezomib (VELCADE) on transcription factor nuclear factor-kappaB (NF-kappaB) and target genes and the feasibility of combination therapy with reirradiation in patients with recurrent head-and-neck squamous cell carcinoma (HNSCC). METHODS AND MATERIALS: The tolerability and response to bortezomib 0.6 mg/m2 and 0.9 mg/m2 given twice weekly concurrent with daily reirradiation to 50-70 Gy was explored. Blood proteasome inhibition and NF-kappaB-modulated cytokines and factors were measured. Proteasome inhibition, nuclear localization of NF-kappaB phospho-p65, apoptosis, and expression of NF-kappaB-modulated mRNAs were compared in serial biopsies from accessible tumors. RESULTS: The maximally tolerated dose was exceeded, and study was limited to 7 and 2 patients, respectively, given bortezomib 0.6 mg/m2 and 0.9 mg/m2/dose with reirradiation. Grade 3 hypotension and hyponatremia were dose limiting. Mucositis was Grade 3 or less and was delayed. The mean blood proteasome inhibition at 1, 24, and 48 h after 0.6 mg/m2 was 32%, 16%, and 7% and after 0.9 mg/m2 was 56%, 26%, and 14%, respectively. Differences in proteasome and NF-kappaB activity, apoptosis, and expression of NF-kappaB-modulated cell cycle, apoptosis, and angiogenesis factor mRNAs were detected in 2 patients with minor tumor reductions and in serum NF-kappaB-modulated cytokines in 1 patient with a major tumor reduction. CONCLUSIONS: In combination with reirradiation, the maximally tolerated dose of bortezomib was exceeded at a dose of 0.6 mg/m2 and the threshold of proteasome inhibition. Although this regimen with reirradiation is not feasible, bortezomib induced detectable differences in NF-kappaB localization, apoptosis, and NF-kappaB-modulated genes and cytokines in tumor and serum in association with tumor reduction, indicating that other schedules of bortezomib combined with primary radiotherapy or reirradiation may merit future investigation.
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Antineoplásicos/uso terapéutico , Ácidos Borónicos/uso terapéutico , Carcinoma de Células Escamosas/terapia , Expresión Génica/efectos de los fármacos , Neoplasias de Cabeza y Cuello/terapia , FN-kappa B/antagonistas & inhibidores , Recurrencia Local de Neoplasia/terapia , Inhibidores de Proteasas/uso terapéutico , Pirazinas/uso terapéutico , Adulto , Anciano , Apoptosis/efectos de los fármacos , Apoptosis/genética , Bortezomib , Carcinoma de Células Escamosas/tratamiento farmacológico , Carcinoma de Células Escamosas/genética , Carcinoma de Células Escamosas/radioterapia , Citocinas/sangre , Femenino , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/genética , Neoplasias de Cabeza y Cuello/radioterapia , Humanos , Masculino , Persona de Mediana Edad , Mucosa Bucal , FN-kappa B/análisis , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/genética , Recurrencia Local de Neoplasia/radioterapia , Estomatitis/etiología , Factor de Transcripción ReIA/análisisRESUMEN
In March, 2002, the Society of Otorhinolaryngology and Head-Neck Nurses, Inc. (SOHN) conducted a web-based survey of members' knowledge of and satisfaction with its portfolio of products and services. This paper reports on the process of developing and conducting the survey, as well as its findings. A new "Volunteer Agreement/Code of Conduct", piloted for this team's work is introduced. General and specific recommendations are put forth for SOHN members and leaders, including useful information to facilitate work for future survey teams.
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Actitud del Personal de Salud , Enfermeras y Enfermeros/psicología , Otolaringología , Sociedades de Enfermería/normas , Especialidades de Enfermería , Escolaridad , Empleo/estadística & datos numéricos , Necesidades y Demandas de Servicios de Salud , Humanos , Internet , Enfermeras y Enfermeros/estadística & datos numéricos , Características de la Residencia/estadística & datos numéricos , Especialidades de Enfermería/educación , Especialidades de Enfermería/organización & administración , Encuestas y Cuestionarios , Estados UnidosRESUMEN
Caregiving is an important component in the management of patients with a tracheostomy or laryngectomy. The purpose of this integrative research literature review was to gain a better understanding of the impact of caregiving for adults and children with laryngectomy or tracheostomy on the patient, the family, and the caregiver. Patients who had undergone laryngectomy or tracheostomy included those with and without cancer. This integrated review of the literature on caregiving in this population demonstrates the dearth of studies on this subject. Despite the significance of the caregiving role, few studies have addressed caregiving, and those that have are primarily descriptive. Studies are needed that develop and test interventions to assist caregivers in adaptation to their role, identification of methods of decreasing caregiver burden and strain, and coordination of resources to support patients and caregivers of patients with tracheostomies and laryngectomies.