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1.
Augment Altern Commun ; 38(3): 135-147, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35726671

RESUMO

This study explored performance on expressive and receptive graphic symbol tasks and spoken comprehension by individuals who use augmentative and alternative communication (AAC) as well as the relationship of performance with participants' skills and characteristics. Participants were 19 children and youth (aged 5- to 18-years-old) who used aided communication. Four experimental tasks were administered, with either speech or symbols as input (stimuli) and symbols or choice from an array of pictures as output (response). Symbols were not accompanied by written or spoken labels in the tasks. Measures of receptive vocabulary, receptive syntax, memory, and visual cognitive skills as well as information regarding participant characteristics were collected. There were strong relationships among all experimental tasks. Cluster analysis revealed different response patterns that may suggest a progression in expressive and receptive performance with graphic symbol sentences. Individual differences in receptive language, particularly receptive syntax, were related to task performance. The findings suggest that different ways of experiencing symbols, in addition to spoken comprehension of the sentences and receptive spoken language more generally, may contribute to expressive graphic symbol sentences. Performance on receptive symbol tasks may uncover a level of facility with the graphic-symbol modality not observed through expressive symbol use in communicative situations.


Assuntos
Auxiliares de Comunicação para Pessoas com Deficiência , Transtornos da Comunicação , Criança , Adolescente , Humanos , Pré-Escolar , Idioma , Vocabulário , Comunicação
2.
Augment Altern Commun ; 30(3): 187-99, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25109228

RESUMO

While research on spoken language has a long tradition of studying and contrasting language production and comprehension, the study of graphic symbol communication has focused more on production than comprehension. As a result, the relationships between the ability to construct and to interpret graphic symbol sequences are not well understood. This study explored the use of graphic symbol sequences in children without disabilities aged 3;0 to 6;11 (years; months) (n=111). Children took part in nine tasks that systematically varied input and output modalities (speech, action, and graphic symbols). Results show that in 3- and 4-year-olds, attributing meaning to a sequence of symbols was particularly difficult even when the children knew the meaning of each symbol in the sequence. Similarly, while even 3- and 4-year-olds could produce a graphic symbol sequence following a model, transposing a spoken sentence into a graphic sequence was more difficult for them. Representing an action with graphic symbols was difficult even for 5-year-olds. Finally, the ability to comprehend graphic-symbol sequences preceded the ability to produce them. These developmental patterns, as well as memory-related variables, should be taken into account in choosing intervention strategies with young children who use AAC.


Assuntos
Desenvolvimento Infantil , Auxiliares de Comunicação para Pessoas com Deficiência , Comunicação , Compreensão , Desenvolvimento da Linguagem , Fala , Criança , Pré-Escolar , Feminino , Humanos , Masculino
3.
Diagnostics (Basel) ; 14(13)2024 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-39001311

RESUMO

Pulmonary actinomycosis is an uncommon clinical entity that can be challenging to diagnose due to its non-specific symptomatology. Misdiagnosis and delayed treatment may result in invasive procedures and extended antimicrobial treatment courses. We report a case involving a 65-year-old female with poor oral dentition admitted for acute respiratory failure subsequently found to have a left-sided pleural effusion and perihepatic abscess formation. Cytopathology examination and microbiology studies confirmed the diagnosis of pulmonary actinomycosis.

4.
Int J Speech Lang Pathol ; : 1-13, 2023 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-37778369

RESUMO

PURPOSE: The present study examines cross-sectional trends in performance on a quasi-universal non-word repetition (NWR) task. It also considers whether NWR performance is dependent on levels of exposure to a language and compares the performance of bilingual children across their two languages. METHOD: A cross-sectional design was employed. The English and French quasi-universal NWR tasks, featuring stimuli from two to five syllables in length, was administered to Canadian school-aged monolinguals and two groups of bilinguals: those who encountered their second language in early childhood and those who encountered their second language at school entry. RESULT: When evaluated in English, the early-exposure bilinguals produced significantly fewer errors than the school-entry exposure bilinguals and the English monolingual groups. When evaluated in French, the early-exposure bilinguals and the French monolinguals produced significantly fewer errors than the school-entry exposure bilinguals. Compared across languages, the French monolinguals produced fewer errors on the French version of the NWR task than the English monolinguals did on the English version of the same task. In both languages and across all analyses, the youngest age group (7-8 years) produced more errors than the two older groups (9-10 years and 11-12 years). CONCLUSION: The quasi-universal NWR task showed sensitivity to improvements from 7 to 11 years of age in English and up to 9 years of age in French. Better performance in French may be due to the relatively greater frequency of multisyllabic words in that language. The development and use of this particular NWR task with monolinguals and bilinguals-in both of their languages-contribute to a deeper understanding of quasi-universal NWR performance in typically developing children.

5.
Diagn Cytopathol ; 51(10): 589-595, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37335285

RESUMO

BACKGROUND: Primary lung cancer is the leading cause of cancer death in the United States. Most lung cancers are diagnosed in an outpatient setting, but a subset requires intraoperative diagnosis. Two intraoperative diagnostic methods are available, frozen section (FS) and fine needle aspiration (FNA) cytology. This study compares intraoperative FNA cytology and FS based diagnosis in thoracic malignancies within the same clinical practice. METHODS: Pathology reports from thoracic intraoperative FNA cytology or FS (January 2017-December 2019) were reviewed. Resection diagnosis was the gold standard. If unavailable, concurrent biopsy and final FNA cytology diagnosis were the gold standard. RESULTS: Of 300 FNA specimens (155 patients), 142 (47%) cases were benign, and 158 (53%) were malignant. Adenocarcinoma was the most common malignant diagnosis (40%), followed by squamous cell carcinoma (26%), neuroendocrine tumors (18%), and other (16%). Intraoperative FNA yielded 88% sensitivity, 99% specificity, and 92% accuracy (p < .001). Of 298 FS specimens (252 patients), 215 (72%) cases were malignant and 83 (28%) were benign. Adenocarcinomas was the most common malignant diagnosis (48%), followed by squamous cell carcinoma (25%), metastatic carcinomas (13%), and other (14%). FS yielded 97% sensitivity, 99% specificity, and 97% accuracy (p < .001). CONCLUSION: Our findings confirm FS is the gold standard for intraoperative diagnosis. FNA cytology may be useful as a non-invasive, inexpensive initial diagnostic tool intraoperatively, given the similar specificity (99% FNA, 99% FS) and accuracy (92% FNA, 97% FS). Negative FNA could be followed by the costlier and invasive FS. We encourage surgeons to utilize intraoperative FNA first.


Assuntos
Adenocarcinoma , Carcinoma de Células Escamosas , Neoplasias Pulmonares , Humanos , Biópsia por Agulha Fina/métodos , Secções Congeladas , Sensibilidade e Especificidade , Adenocarcinoma/diagnóstico , Neoplasias Pulmonares/diagnóstico
6.
Augment Altern Commun ; 28(2): 96-105, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22670727

RESUMO

In order to understand a sequence of graphic symbols as sentences, one must not only recognize the meaning of individual symbols but also integrate their meaning together. In this study children without disabilities were asked to perform two tasks that presented sequences of graphics as stimuli but that differed in the need to treat the symbols as a sentence (i.e., with evidence of relationships among the individual symbols): a "reading" task (transpose the symbol sequence into speech), and an act-out task (demonstrate the meaning of the symbol sequences using puppets). The participants, aged 3 (n=18), 4 (n=36), 5 (n=27), and 6 (n=23) years, all succeeded on the reading task, but the younger groups were much less successful than the older groups on the act-out task. The children were more likely to pass the act-out task if they used conjugated rather than infinitive verb forms in their spoken responses on the reading task. In the younger age groups, children who used conjugated verb forms had higher receptive vocabulary scores. The findings suggest that being able to reproduce a sequence of symbols does not guarantee that the symbols are treated as a sentence. The inclusion in the study of children who were able to respond using speech, permitted observation of two types of responses (conjugated versus infinitive verb forms) that revealed different levels of understanding of graphic symbol sequences.


Assuntos
Desenvolvimento da Linguagem , Leitura , Fala , Vocabulário , Fatores Etários , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Estatísticas não Paramétricas
7.
Am J Clin Pathol ; 158(6): 692-701, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-36197800

RESUMO

OBJECTIVES: Monitoring of frozen section diagnostic performance provides an important quality improvement measure. METHODS: Surgical specimens involving a frozen section diagnosis over a 3-year period were retrospectively reviewed. Glass slides were reviewed on cases with discordance. Discordance and deferral rates were calculated. RESULTS: Of 3,675 frozen section diagnoses included, 96 (2.7%) were discordant with the final diagnosis. Additionally, 114 frozen section diagnoses (3.1%) were deferred. The organ-specific discordance rates were lowest in breast and genitourinary specimens and highest for pancreas, lymph node, and gynecologic specimens. Deferral rates were highest in musculoskeletal, breast, and hepatobiliary cases and lowest in thyroid, parathyroid, and neuropathology cases. Discordance was explained by block-sampling error (45%), specimen-sampling error (27%), or interpretation error (27%). Discordant frozen section diagnoses from gynecologic specimens were responsible for 81% of specimen-sampling errors; frozen section diagnoses of lymph nodes, head and neck, and pancreas were responsible for 54% of interpretation errors; 51% of block-sampling errors involved lymph node evaluation for metastatic carcinoma. CONCLUSIONS: Careful gross evaluation and microscopic examination of multiple levels should minimize specimen-sampling error and block-sampling error, respectively. Periodic review of accuracy and deferral rates may help reduce errors and improve the overall performance of this essential procedure.


Assuntos
Secções Congeladas , Patologia Cirúrgica , Feminino , Humanos , Secções Congeladas/métodos , Patologia Cirúrgica/métodos , Período Intraoperatório , Estudos Retrospectivos , Erros de Diagnóstico/prevenção & controle
8.
Int J Speech Lang Pathol ; 23(2): 155-167, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32366126

RESUMO

PURPOSE: To explore expressive and receptive use of speech and graphic symbols and relationships with linguistic and cognitive skills in children with typical development. METHOD: Participants were 82 children with typical development (4 to 9 years). Measures of memory, visual analysis skills, and receptive language were used, along with five experimental tasks with speech or symbols as input (stimulus) or output (response), using single clause and compound clause stimuli. Cluster analysis grouped participants with similar performances patterns, who were then compared on linguistic and cognitive skill measures. RESULT: The lowest performing group sometimes accurately interpreted graphic symbol utterances that were visible during responding. The mid-performing group was stronger on expressive than receptive symbol utterances when the model did not remain visible. The highest group was comparable on expressive and receptive symbol tasks, but nonetheless stronger with spoken utterances. Relationships of linguistic and cognitive skills with task performance differed across the clusters. CONCLUSION: The findings help clarify the input-output modality asymmetry in graphic symbol communication. Spoken language proficiency does not directly transfer to sentence-level expressive and receptive graphic symbol use. Exploring potentially challenging sentence-level phenomena is important. Research is warranted to explore developmental progressions and potential clinical applications more systematically.


Assuntos
Idioma , Fala , Criança , Humanos , Desenvolvimento da Linguagem , Testes de Linguagem , Linguística
9.
J Child Lang ; 37(1): 1-26, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19323859

RESUMO

Children who require augmentative and alternative communication (AAC) systems while they are in the process of acquiring language face unique challenges because they use graphic symbols for communication. In contrast to the situation of typically developing children, they use different modalities for comprehension (auditory) and expression (visual). This study explored the ability of three- and four-year-old children without disabilities to perform tasks involving sequences of graphic symbols. Thirty participants were asked to transpose spoken simple sentences into graphic symbols by selecting individual symbols corresponding to the spoken words, and to interpret graphic symbol utterances by selecting one of four photographs corresponding to a sequence of three graphic symbols. The results showed that these were not simple tasks for the participants, and few of them performed in the expected manner - only one in transposition, and only one-third of participants in interpretation. Individual response strategies in some cases lead to contrasting response patterns. Children at this age level have not yet developed the skills required to deal with graphic symbols even though they have mastered the corresponding spoken language structures.


Assuntos
Linguagem Infantil , Comunicação não Verbal , Pré-Escolar , Auxiliares de Comunicação para Pessoas com Deficiência , Humanos , Testes de Linguagem , Análise e Desempenho de Tarefas
10.
Augment Altern Commun ; 26(2): 108-21, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20497074

RESUMO

Graphic symbols are often used to represent words in Augmentative and Alternative Communication systems. Previous findings suggest that different processes operate when using graphic symbols and when using speech. This study assessed the ability of native speakers of French with no communication disorders from four age groups to interpret graphic-symbol sequences of varying length and canonicity. Results reveal that, as they get older, participants show an increase in their capacity to interpret graphic-symbol sequences. Constituent order played an important role in the interpretation of the sequences. However, the specific word-order strategies used varied depending on the age group and the type of sequence presented.


Assuntos
Envelhecimento , Linguagem Infantil , Linguística , Simbolismo , Adolescente , Adulto , Criança , Pré-Escolar , Computadores , Humanos , Testes de Linguagem , Estimulação Luminosa , Psicolinguística , Software
11.
Augment Altern Commun ; 26(4): 299-312, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21091304

RESUMO

Given the frequent use of graphic symbols in augmentative and alternative communication (AAC) systems, some individuals who use AAC may have greater familiarity with constructing graphic-symbol sequences than do speaking individuals without disabilities. Whether this increased familiarity has an impact on the interpretation of such sequences or on the relationship between construction and interpretation is fundamental to our understanding of the mechanisms underlying communication using graphic symbols. In this study, individuals who use graphic-symbol AAC systems were asked to construct and interpret graphic-symbol sequences representing the same target content (simple and complex propositions). The majority of participants used stable response patterns on both tasks; a minority were inconsistent on both tasks. Asymmetrical patterns (stable on one task but not the other) were rare, suggesting that neither channel (construction or interpretation) preceded the other, in contrast to earlier findings with participants without disabilities (i.e., novice users of graphic symbols). Furthermore, there were differences between stable and less stable responders on measures of syntactic comprehension and cognitive level but not on chronological age, receptive vocabulary, or AAC system characteristics and length of use.


Assuntos
Auxiliares de Comunicação para Pessoas com Deficiência , Comunicação , Adolescente , Adulto , Criança , Cognição , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reconhecimento Psicológico , Percepção da Fala , Adulto Jovem
12.
PLoS One ; 15(4): e0231654, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32340024

RESUMO

In marine environments, tropical and subtropical habitats are considered to be inherently less productive than more temperate systems. As such, foraging site fidelity among vertebrate predators occupying low-latitude marine systems is generally low as a response to an increased unpredictability of resources. We investigated the foraging movements of Masked Boobies breeding on Middle Cay, Jamaica using GPS loggers to examine if the presence of a nearby bathymetric feature influenced foraging site fidelity in a tropical system, the Caribbean Sea. According to the movements of tracked individuals, this population of boobies shows a high degree of spatial fidelity in foraging site selection, concentrated on the northern edge of Pedro Bank. We suggest this feature as an important location for marine conservation in the region and demonstrate its utility to foraging boobies via habitat modeling using a maximum entropy approach of relevant habitat variables. Finally, we place this study into the global context of Masked Booby foraging by examining the published literature of relevant tracking studies for population-level similarity in foraging metrics. According to hierarchical clustering of foraging effort, Masked Boobies demonstrate a density-dependent response to foraging effort regardless of colony origin or oceanic basin consistent with the principles of Ashmole's Halo.


Assuntos
Aves/fisiologia , Comportamento Consumatório , Comportamento Espacial , Animais , Ecossistema , Espécies em Perigo de Extinção , Jamaica , Movimento
13.
Mol Cell Biol ; 26(8): 3029-38, 2006 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-16581778

RESUMO

BUR1 and BUR2 encode the catalytic and regulatory subunits of a cyclin-dependent protein kinase complex that is essential for normal growth and has a general role in transcription elongation. To gain insight into its specific role in vivo, we identified mutations that reverse the severe growth defect of bur1Delta cells. This selection identified mutations in SET2, which encodes a histone methylase that targets lysine 36 of histone H3 and, like BUR1, has a poorly characterized role during transcription elongation. This genetic relationship indicates that SET2 activity is required for the growth defect observed in bur1Delta strains. This SET2-dependent growth inhibition occurs via methylation of histone H3 on lysine 36, since a methylation-defective allele of SET2 or a histone H3 K36R mutation also suppressed bur1Delta. We have explored the relationship between BUR1 and SET2 at the biochemical level and find that histone H3 is monomethylated, dimethylated, and trimethylated on lysine 36 in wild-type cells, but trimethylation is significantly reduced in bur1 and bur2 mutant strains. A similar methylation pattern is observed in RNA polymerase II C-terminal domain truncation mutants and in an spt16 mutant strain. Chromatin immunoprecipitation assays reveal that the transcription-dependent increase in trimethylated K36 over open reading frames is significantly reduced in bur2Delta strains. These results establish links between a regulatory protein kinase and histone methylation and lead to a model in which the Bur1-Bur2 complex counteracts an inhibitory effect of Set2-dependent histone methylation.


Assuntos
Quinases Ciclina-Dependentes/fisiologia , Proteínas de Ligação a DNA/fisiologia , Proteínas Fúngicas/fisiologia , Regulação Fúngica da Expressão Gênica , Histonas/metabolismo , Proteínas de Saccharomyces cerevisiae/fisiologia , Fatores de Transcrição/fisiologia , Alelos , Western Blotting , Imunoprecipitação da Cromatina , Quinases Ciclina-Dependentes/genética , Proteínas de Ligação a DNA/genética , Deleção de Genes , Genes Fúngicos , Histona-Lisina N-Metiltransferase , Histonas/química , Lisina/metabolismo , Metilação , Fases de Leitura Aberta , Saccharomyces cerevisiae/enzimologia , Saccharomyces cerevisiae/genética , Saccharomyces cerevisiae/metabolismo , Proteínas de Saccharomyces cerevisiae/genética , Fatores de Transcrição/genética
14.
J Deaf Stud Deaf Educ ; 14(4): 465-85, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19461113

RESUMO

This study examined receptive and expressive vocabulary and grammar achievement of French-speaking children (n = 27) who received a cochlear implant (CI) between the age of 1 and 2. Standardized measures of language achievement were administered and the language levels attained by children with CIs were compared with that of the normative sample of same-age hearing peers for each measure. As a group, children exhibited language levels within normal limits in all standardized language measures. Examination of individual patterns revealed four different language profiles ranging from normal language levels in all domains to general language delay. Half the participants displayed language levels on par with similar-age peers at the word level; less than half the children obtained average performance at the sentence level. In three of these profiles, comprehension of sentences was impaired. Moreover, the age at implantation was not associated with language achievement. Findings suggest that receiving a CI between the age of 1 and 2 years does not ensure that language abilities will be within normal limits after up to 6 years of experience with the implant.


Assuntos
Implante Coclear , Perda Auditiva Bilateral/cirurgia , Lactente , Desenvolvimento da Linguagem , Criança , Pré-Escolar , Compreensão , Feminino , Humanos , Estudos de Linguagem , Transtornos do Desenvolvimento da Linguagem , Masculino , Percepção da Fala , Vocabulário
15.
Cytojournal ; 16: 6, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31031816

RESUMO

The advent of fiberoptic endoscopy with biopsy has revolutionized procurement of specimens from deep sites. This has translated into more cytologic specimens whereby the material is limited and best handled by cytology laboratory staff. While the diagnosis of the pathologic process is of utmost importance, there is increasing expectation that the diagnosis be specific and accurate as not to require additional biopsy for initiation of treatment. This expectation has driven demand in immunohistochemical (IHC) and molecular studies conducted specifically on material processed as cytology specimens. The Clinical Laboratory Improvement Amendments of 1988 requires laboratories in the United States of America to verify the performance of patient tests. Due to varying laboratory practices with respect to validation of IHC assays, the College of American Pathologists introduced guidelines for analytic validation of IHC tests. These guidelines address how to perform validation by recommending the number of cases in the validation set, comparator concordance, and when to revalidate. The main thrust of the guidelines is based on formalin-fixed paraffin-embedded tissue with only one expert consensus opinion referring to validation of IHC tests on cytology specimens which delegates to the medical director, the determination of number of positive and negative cases to be tested. This article will outline how an academic center approaches validation of IHC studies performed on cytology cell block specimens using the College of American Pathologists guidelines. A stepwise approach from selection of antibodies to validate followed by building the validation panel and evaluating the stain results for concordance against the gold standard of histology tissue specimen will be described. A rationale for dealing with discordant results and future innovations will conclude the report.

16.
ACG Case Rep J ; 6(3): 1-4, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31620495

RESUMO

Esophageal squamous cell carcinoma (ESCC) is the predominant type of esophageal carcinoma worldwide. It occurs mostly in the upper and middle thirds of the esophagus. We present the case of a young African American woman with Goltz syndrome who presented with dysphagia and weight loss and was found to have distal esophageal papillomatosis and squamous cell carcinoma. This occurrence of ESCC in an atypical location in a young woman without traditional risk factors is suggestive of malignant transformation of underlying papillomatosis. Goltz syndrome is a rare disorder, occasionally associated with esophageal papillomatosis. Although esophageal papillomatosis is considered to be benign, our case shows that it could have malignant potential and hence is likely worthy of surveillance.

17.
Physiother Can ; 71(1): 1-10, 2019.
Artigo em Francês | MEDLINE | ID: mdl-30787493

RESUMO

Purpose: The main purpose is to produce a French-Canadian translation of the "STrengthening the Reporting of OBservational studies in Epidemiology" (STROBE) Statement under the proposed name of "outil STROBE" and to assess the cross-cultural validity of its content. The secondary purpose is to examine its preliminary interrater reliability. Method: A modified approach to Vallerand's cross-cultural validation methodology was used. First, professional translators and clinical practitioners produced a parallel reverse translation of the "STROBE Statement." Then, a committee of experts (P1) examined the translated versions and created a first experimental draft of the "outil STROBE." This draft was assessed and modified by a second committee of experts (P2). Finally, 32 future professionals doing their master's degree in physiotherapy and occupational therapy assessed this second experimental version of the tool using an ambiguity scale of 8 points (0 meaning "not at all ambiguous" and 7 meaning "extremely ambiguous"). The main co-researchers examined the problematic elements and proposed final modifications. Ten observational studies published in French after 1980 were assessed by two independent raters using the French-Canadian version of the "outil STROBE." The kappa coefficient was used to examine interrater reliability. Results: For the different elements of the final version of the "outil STROBE," the averages on the ambiguity scale varied from 0.0 to 2.4. No element received an average below 2.4, which showed a high level of clarity. The interrater reliability (n = 2) for the "outil STROBE" is thought to be good for 74% of individual elements, according to the kappa coefficient values obtained. Conclusions: The process's five rigorous steps enabled the production of a valid French-Canadian version of the "STROBE Statement."

18.
Physiother Can ; 71(3): 222-230, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31719718

RESUMO

Purpose: The main purpose of this article is to produce a French-Canadian translation of the Consolidated criteria for reporting qualitative studies (COREQ) scale under the proposed name "échelle COREQ" and to assess the transcultural validity of its content. The secondary purpose is to examine the inter-rater reliability of the French-Canadian version of the COREQ scale. Method: A modified approach to Vallerand's methodology (1989) for cross-cultural validation was used. First, a parallel back-translation of the COREQ scale was performed, by both professionals and clinicians. Next, a first committee of experts(P1) examined the translations to create a first draft of the French-Canadian version of the COREQ scale. This draft was then evaluated and modified by a second committee of experts (P2). Finally, 28future professionals (master's students in physiotherapy) rated this second draft of the tool for clarity using a seven-point scale (1:very clear; 7:very ambiguous). The principal co-investigators then reviewed the problematic elements and proposed final changes. Two independent raters used this French-Canadian version of the COREQ scale to assess 13qualitative studies that were published in French after the year2007. The kappa coefficient was used to examine inter-rate reliability. Results: The different elements of the final version of the COREQ scale received an average ambiguity rating between 1.04 and 2.56. These low values show a high level of clarity for the French-Canadian version of the COREQ scale. In relation to the total score of the COREQ scale, inter-rater reliability (n = 2) is considered to be average to excellent for 62.5% of individual elements, according to the kappa values obtained. Conclusions: A valid French-Canadian version of the COREQ scale was created using this rigorous five-step process.

19.
Clin Infect Dis ; 46 Suppl 2: S112-4; discussion S144-51, 2008 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-18181713

RESUMO

Marketing approval of biological products by the US Food and Drug Administration must comply with requirements of Code of Federal Regulations title 21 part 25, "Environmental Impact Considerations." An environmental impact statement is usually not required. Environmental assessment is required unless excluded. As naturally occurring substances, biological products qualify for categorical exclusion if manufacture and use do not significantly alter their concentration or distribution in the human environment. The manufacturing process and establishment descriptions in the license application should include enough detail to ensure that waste is controlled and inactivated. During clinical development of a live biotherapeutic product, data should be collected regarding the shedding of live organisms from treated patients. The ability of the live organism to persist in the environment should be assessed, and instructions for safe handling by health care providers and consumers should be incorporated into the package insert.


Assuntos
Produtos Biológicos/normas , Produtos Biológicos/uso terapêutico , Meio Ambiente , Probióticos/normas , Probióticos/uso terapêutico , Produtos Biológicos/efeitos adversos , Aprovação de Drogas , Indústria Farmacêutica/normas , Microbiologia Ambiental/normas , Monitoramento Ambiental/normas , Indústria Alimentícia/normas , Humanos , Probióticos/efeitos adversos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência , United States Food and Drug Administration/normas
20.
Clin Infect Dis ; 46 Suppl 2: S128-32; discussion S144-51, 2008 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-18181718

RESUMO

Elements of product and manufacturing-process design are described for product development of live biotherapeutic biological drugs. Product design uses the history and the phenotypic and genotypic characterization of the selected strain. The quality and integrity of the selected strain can be ensured by preservation in a qualified cell-bank system. Manufacturing-process design includes step-by-step description, including the necessary process-input parameters and the expected output results. The active ingredients in the biological drug are usually manufactured using aseptic processing. The manufacture of the final dosage form of live biotherapeutics requires bioburden control or aseptic manufacture, as appropriate. Specifications for live biotherapeutics must comply with regulations for licensed biological products. Evidence of stability for the duration of the shelf life, as well as stability under the recommended conditions of use, must be provided for licensure.


Assuntos
Produtos Biológicos/normas , Produtos Biológicos/uso terapêutico , Indústria Farmacêutica/normas , Probióticos/normas , Probióticos/uso terapêutico , Bactérias/classificação , Qualidade de Produtos para o Consumidor , Indústria Farmacêutica/legislação & jurisprudência , Indústria Farmacêutica/métodos , Humanos , Controle de Qualidade
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