The well-documented problems associated with mapping raw rates of disease have resulted in an increased use of Bayesian hierarchical models to produce maps of "smoothed'' estimates of disease rates. Two statistical problems arise in using Bayesian hierarchical models for disease mapping. The first problem is in comparing goodness of fit of various models, which can be used to test different hypotheses. The second problem is in identifying outliers/divergent regions with unusually high or low residual risk of disease, or those whose disease rates are not well fitted. The results of outlier detection may generate further hypotheses as to what additional covariates might be necessary for explaining the disease. Leave-one-out cross-validatory (LOOCV) model assessment has been used for these two problems. However, actual LOOCV is time-consuming. This thesis introduces two methods, namely iIS and iWAIC, for approximating LOOCV, using only Markov chain samples simulated from a posterior distribution based on a full data set. In iIS and iWAIC, we first integrate the latent variables without reference to holdout observation, then apply IS and WAIC approximations to the integrated predictive density and evaluation function. We apply iIS and iWAIC to two real data sets. Our empirical results show that iIS and iWAIC can provide significantly better estimation of LOOCV model assessment than existing methods including DIC, Importance Sampling, WAIC, posterior checking and Ghosting methods.

During the past two decades, there has been an explosive volume of software applied in the field of heath care. As medical software becomes pervasive in all facets of health care services, the risk of software related patient injuries and patient deaths is also on the rise. To assure the quality of medical software, rigorous validation and verification methods must be employed to analyze all phases of development and final products. In this thesis, a systematic review was conducted to examine and summarize research in the area of medical software certification, which is the primary quality assurance approach taken by regulatory bodies. Key findings indicate that research in the field of medical software certification is sparse, with a limited range of focus and research methodologies. Greater effort using empirical research approaches is necessary for the improvement of current research in medical software certification. / Graduate

Orientador: Alberto José Cavalheiro / Banca: Jairo Kenupp Bastos / Banca: José Angelo Silveira Zuanazzi / Resumo: A espécie Trichilia catigua, é uma árvore de 3 a 5 metros de altura, de distribuição ampla nos países da América do Sul, é conhecida como catuaba ou catiguá ou Angelim rosa, é utilizada popularmente como tônico mental e físico e especialmente como estimulante sexual. Cinchonaínas A e B foram escolhidas como marcadores químicos para a padronização do extrato hidroalcóolico de cascas de catuaba por serem as substâncias majoritárias desse extrato e também possuírem atividades antioxidante e antibacteriana. Como os padrões de cinchonaínas ainda não são comercializados foi realizado, neste trabalho, o isolamento, identificação, determinação de pureza absoluta e estudo de estabilidade destes compostos para que possam ser utilizados adequadamente como padrões de trabalho. A purificação das cinchonaínas foi feita em CLAE preparativo, utilizando coluna de fase reversa C18 e gradiente linear de CH3COOH (0,1%) em H2O/MeOH e a identificação foi realizada através da análise dos espectros de massas de alta resolução e RMN de 1H e 13C. Foram realizados também estudos de estabilidade em solução para cinchonaína A, B e extrato hidroalcóolico da casca de catuaba em diferentes condições de armazenamento. Os estudos de estabilidade acelerada foram realizados de acordo com RE 398 da ANVISA em condições de temperatura (40ºC) e umidade (75% UR). Estes estudos indicaram que os padrões de cinchonaína A e B são estáveis quando mantidos secos sob condições ambientais, com prazo de validade estimado de dois anos. No entanto, em solução hidrometanólica (MeOH:H2O 1:1) ocorre rápida oxidação com formação das di - orto - quinonas, indicando que as soluções mães desses padrões não podem ser estocados por mais de 1 dia. O estudo de estabilidade em solução, mostrou que o perfil cromatográfico das soluções hidroalcóolicas da planta não apresentou... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Trichilia catigua, is a tree which grows 6.56 to 13.12 feet, widely distributed in South America, and is known as catuaba, catiguá or Angelim renders rose-colored and is popular used as mental and physical tonic and especially as sexual stimulant. Cinchonains A and B were chosen as chemical markers to standardize the extract in focus due the major concentration of those substances in the hydroalcoholic extract from bark of catuaba and also due to antioxidant and anti bacterial activities related to them. Since the cinchonains standards are not commercialized, we had to perform the isolation, identification, absolute purity and stability study of these compounds, so that they could be properly used as standards. The cinchonains purification was performed in HPLC using preparative C-18 reverse phase column and H2O/MeOH as solvent, by running a linear gradient. The identification was obtained through high resolution mass spectrum and 1H e 13C NMR (Nuclear Magnetic Resonance). Stability studies were executed in solution of cinchonain A, B and hydroalcoholic extract from bark of catuaba in different storage conditions. The accelerated stability studies were performed according to RE 398, November 12nd of 2004 - ANVISA under temperature of 40 °C and humidity of 75% UR. These studies indicated that standards of cinchonain A and B are stable when they are dried and kept under ambient conditions, having a shelf life estimated of two years. However, in hydromethanol solution (MeOH:H2O 1:1), rapid oxidation occurs leading to di-orthoquinones formation, indicating that stock standards solutions cannot be stored more than 1 day. The stability study on solution showed that the chromatographic profile of the plant hydroalcoholic solution did not present alteration within 7 days, indicating that samples can be prepared and stored during this period. The parameters... (Complete abstract click electronic access below) / Mestre

Neste trabalho, foram desenvolvidos e validados métodos analítico e microbiológico, bem como estudo preliminar de estabilidade, cinética de degradação e citotoxicidade da Ceftarolina Fosamila em pó para solução injetável, um antibiótico da classe das cefalosporinas de quinta geração, indicado para pneumonias adquiridas na comunidade e infecções graves, de pele e tecidos moles. A validação do ensaio microbiológico pelo método de difusão em ágar cilindros em placa, delineamento 3x3, apresentou resultados satisfatórios, como especificidade, linearidade na faixa de 2,0 - 8,0 μg/mL, precisão (109,42 %), exatidão (102,3 %) e robustez. Soluções de Cefatarolina Fosamila do produto acabado expostas à radiação UVC (254 nm) e à degradação térmica a 60 °C foram utilizadas para avaliar a especificidade do bioensaio. A robustez foi avaliada através da alteração da concentração do meio inoculado (0,8 e 1,2 %). O desenvolvimento e validação de método por CLAE foi avaliado através da especificidade, linearidade, precisão, exatidão e robustez. No método cromatográfico foi utilizado cromatógrafo à liquido de alta eficiência SHIMADZU com coluna Agilent® C18, fase móvel (água com trietilamina 1,0% pH 5,0:acetonitrila 87:13 v/v). O método apresentou-se específico, linear, no intervalo de 5,0 - 60,0 μg/mL, preciso (110,0 %), exato (100,68 %) e robusto. Os métodos microbiológico e cromatográfico validados foram comparados estatisticamente e verificou-se não haver diferença significativa entre eles quando comparados através do teste “t” de Student. No estudo preliminar de estabilidade constatou-se ser estável em hidrólise ácida (0,1 M) e luz UVA no período avaliado, e instável frente à degradação térmica (40 e 60 °C), oxidativa com peróxido de hidrogênio, básica em NaOH (0,1 M e 0,01 M) e luz UVC. As cinéticas de degradação frente à luz UVC e degradação térmica 60 °C mostraram que as amostras possuem cinética de degradação de ordem zero e de segunda ordem, respectivamente. O ensaio de citotoxicidade demonstrou não haver diferença entre a condição normal e a amostra submetida à degradação forçada, sugerindo que os possíveis produtos de degradação formados não alteraram o resultado. / In this work, analytical and microbiological methods were developed and validated, as well as a preliminary study of the stability, degradation kinetics and cytotoxicity to Ceftaroline Fosamil powder for injectable solution, this is a fifth generation cephalosporin antibiotic indicated for community-acquired pneumonia and severe infections of the skin and soft tissues. The validation of the microbial assay by diffusion method in 3x3 cylinder agar delineated showed satisfactory results in specificity, linearity in the range of 2.0 - 8.0 μg / mL, precision (109.42 %), accuracy (102.3 %) and robustness. The development and validation of the method by HPLC was evaluated through specificity, linearity, precision, accuracy and robustness. In the chromatographic method was used high performance liquid chromatograph from SHIMADZU with Agilent® C18 column, mobile phase (water with triethylamine 1.0 % pH 5.0: acetonitrile 87:13 v/v). The method was linear, specific in the range of 5.0 - 60.0 μg/mL, accurate (110.0 %), exact (100.68 %) and robust. The validated microbiological and chromatographic methods were compared statistically and there was no significant difference between them when compared through Student's t-test. In the preliminary stability study, it was found stable in acid hydrolysis (0.1M) and UVA light in the period evaluated, and instable against thermal degradation (40 and 60 °C), oxidative with hydrogen peroxide, basic in NaOH (0.1 M and 0.0 1M) and UVC light. Samples exposed in UVC light an thermal degradation at 60°C showed degradation kinetics following zero order and second order, respectively. The cytotoxicity assay showed no difference between the normal condition and the sample submitted to forced degradation, suggesting that the possible degradation products formed did not change the result.

Public health practice and quality of medical care rely heavily on the accuracy, precision, and robustness of risk prediction models. Health care providers use risk prediction models to assess a patient’s risk of developing an event during a specified time frame given the patient’s specific characteristics, and subsequently recommend a course of treatment or preventative action. In public health research, risk prediction models are often constructed with common statistical modeling techniques, such as logistic regression for binary outcomes or Cox proportional hazard regression for time-to-event outcomes, and the performance of the model is assessed through internal or external validation, or some combination. Model validation requires statistical and clinical significance and satisfactory baseline or improvement in model calibration and discrimination: calibration quantifies how close predictions are to observed outcomes while discrimination quantifies the model’s ability to distinguish correctly between events and nonevents. Measures for evaluating these qualities include (but are not limited to) Brier score, calibration-in-the-large, proportion of variation (R2), sensitivity and specificity, area under the receiver operating characteristic curve (AUC), discrimination slope, net reclassification index (NRI), integrated discrimination improvement (IDI), and decision theory analytic measures such as net benefit and relative utility. Among these measures exist several interrelationships under certain assumptions, and their estimation and interpretation is an active area of research. The first two parts of this thesis focus on studying the empirical distributions and improving confidence interval (CI) estimation of ∆AUC, NRI, and IDI for both binary event data and time-to-event data. Through data simulation and the comparison of several CI types derived with bootstrapping techniques, we make recommendations for proper estimation in future work and apply our recommendations to real-life Framingham Heart Study data. The third part of this thesis summarizes the many interrelationships and possible redundancies among the measures listed, extends theoretical formulas assuming normal variables for ∆AUC, NRI, and IDI from nested models to non-nested models and to Brier score, and explores the impact of varying discrimination and calibration assumptions on Yates’ and Sanders’ decomposed versions of Brier score through simulation. Lastly, overall conclusions and future directions are presented at the end.

Gamma-hydroxybutyrate (GHB) is an endogenous compound in the human body, found in regions of the mammalian brain and believed to be a cerebral neurotransmitter.1,2 GHB also acts as a powerful central nervous system depressant commonly used as a “date rape” drug due to its hypnotic and sedative properties.1 The drug has also been used medicinally to treat alcohol withdrawal, opiate-withdrawal syndrome, and narcolepsy.3–5 Toxicological analysis of GHB in drug facilitated sexual assault (DFSA) cases is typically performed using blood and urine specimens.1 However, due to the endogenous nature of GHB, toxicological interpretation of these biological specimens can be complex and challenging.1,4 Additionally, urine and blood analysis of GHB can be impacted by sample collection, sample analysis times, and sample storage conditions.6,7 Due to the challenges and limitations associated with blood and urine analysis of GHB along with the prominence of GHB in DFSA cases, it would be beneficial to determine the possibility of GHB analysis using alternative biological matrices. The primary goal of this research was to develop a sample preparation method that could accurately and reliably identify and quantify GHB in oral fluid, as an alternative biological matrix. Additionally, this research was carried out to compare the identification and quantitation capabilities of GHB in oral fluid to that of traditional biological matrices, specifically urine and blood. The methods employed in this study utilized gas chromatography – mass spectrometry (GC-MS) instrumentation in order to correctly identify GHB. A deuterated internal standard, GHB-d6, was used to quantify all samples. The methods were assessed using the parameters set forth by the Scientific Working Group of Forensic Toxicologists (SWGTOX) for quantitative analysis methods. The following factors were considered: calibration model, bias, precision, limit of detection and quantitation, carryover, and interferences. Urine and blood samples were prepared using 200 uL of urine (UTAK Laboratories, Inc., Valencia, CA, U.S.A.) or blood (Equitech-Bio Inc., Kerrville, TX, U.S.A.), varying amounts of the 200 mg/L working calibrator and control solution prepared using certified reference standards (Cerilliant, Round Rock, TX, U.S.A.), and 50 uL of 100 mg/L working internal standard solution resulting in an internal standard concentration of 25 mg/L in each sample. Solid phase extraction (SPE) was performed using United Chemical Technologies (UCT), Inc. (Bristol, PA, U.S.A) Clean Screen GHB columns (ZSGHB020) on all samples.1 Samples were reconstituted, derivatized, and analyzed using GC-MS. Oral fluid samples were prepared using 1.0 uL of drug-free oral fluid, and 1.0 mg/mL (as salt) in methanol GHB received from Cerilliant. The samples were spiked with 1 uL of 1.0 mg/mL (as salt) in methanol GHB-d6 received from Cerilliant. Each sample had an internal standard concentration of 10 mg/L. Samples were fortified with 100 uL of ethyl acetate, and derivatized with 100 uL of bis(trimethyl)trifluoroacetamide (BSTFA) with 1% Trimethylchlorosilane (TMCS) received from Cerilliant. The samples were incubated, and analyzed using GC-MS.8 All analyses were conducted using an Agilent 7890A GC system, Agilent 5975C Mass Detector System (MSD), and an Agilent 7683B Autosampler (Agilent Technologies Inc. Santa Clara, CA). The chromatographic component was carried out using an Agilent HP5-MS 30m x 250um x 0.25um capillary column and an Agilent HP- 5MS 15m x 250um x 0.25um capillary column. All data was analyzed using Agilent MSD ChemStation software (version E.02.02.1431). The method has a total length of 12.75 minutes. Selective ion monitoring (SIM) was used to monitor the ions of interest for each analyte. GHB-d6 was monitored using the ions 239, 240, and 241. GHB was monitored using the ions 233, 234, 235.1 Results revealed that GHB and GHB-d6 could be identified and differentiated due to their fragmentation patterns. All calibration curves for the three matrices exhibited R2 values > 0.98 using a linear dynamic range of 5-100 mg/L with a minimum of four calibration points. The limit of detection for the three matrices was determined to be 1 mg/L, and the limit of quantitation for the three matrices was determined to be 5 mg/L. Bias and precision were analyzed at concentrations of 8 mg/L, 45 mg/L, and 90 mg/L for each matrix. All urine and blood samples were calculated to be within the acceptance range of +20% bias and +20% coefficient of variation. Oral fluid samples were outside of the +20% acceptance range for both bias and coefficient of variation. The highest concentration analyzed that did not produce carryover into subsequent matrix blanks was found to be 350 mg/L for each matrix. Significant interferences were found to be present in urine and blood samples, but negligible for all oral fluid samples. This research illustrates that the developed sample preparation method can be used to accurately and reliably identify GHB in oral fluid. Additionally, this research suggests that the quantitation capabilities of GHB in oral fluid are not as accurate and precise as those of urine and blood. Therefore, the developed method has better qualitative analysis capabilities, while the urine and blood methods have better quantitative analysis capabilities for forensic toxicology casework.

Walking is one of the most commonplace forms of human expressions, yet the forms, motivations, and practices of walking vary greatly and are often at odds with dominant discourses in urban and transportation planning. As interest in pedestrian-oriented studies continues to grow, there is danger that dominant discourses will continue to reinforce the framing of pedestrians and the practices of walking as slower moving versions of the private automobile and ignore deeply embedded emotional, personal, and cognitive aspects. As such, understandings of pedestrian transportation and human agency during walking must be explored in increasingly human-centered terms in order to understand how changes to the material environment actually impact people and daily practices. The purpose of this dissertation is to give considerably more attention to the human elements of walking by creating a set of new theoretical and practical frameworks for deeper representations of the pedestrian in the urban space and within a larger transportation system. The three articles presented in this dissertation outline an alternative, human-centered representation of the pedestrian, providing theoretical, methodological, and practical solutions to conceptualize how soft variables such as emotion, motivation, and especially cognition influence the practices of walking. / 10000-01-01

Neste trabalho, foram desenvolvidos e validados métodos analítico e microbiológico, bem como estudo preliminar de estabilidade, cinética de degradação e citotoxicidade da Ceftarolina Fosamila em pó para solução injetável, um antibiótico da classe das cefalosporinas de quinta geração, indicado para pneumonias adquiridas na comunidade e infecções graves, de pele e tecidos moles. A validação do ensaio microbiológico pelo método de difusão em ágar cilindros em placa, delineamento 3x3, apresentou resultados satisfatórios, como especificidade, linearidade na faixa de 2,0 - 8,0 μg/mL, precisão (109,42 %), exatidão (102,3 %) e robustez. Soluções de Cefatarolina Fosamila do produto acabado expostas à radiação UVC (254 nm) e à degradação térmica a 60 °C foram utilizadas para avaliar a especificidade do bioensaio. A robustez foi avaliada através da alteração da concentração do meio inoculado (0,8 e 1,2 %). O desenvolvimento e validação de método por CLAE foi avaliado através da especificidade, linearidade, precisão, exatidão e robustez. No método cromatográfico foi utilizado cromatógrafo à liquido de alta eficiência SHIMADZU com coluna Agilent® C18, fase móvel (água com trietilamina 1,0% pH 5,0:acetonitrila 87:13 v/v). O método apresentou-se específico, linear, no intervalo de 5,0 - 60,0 μg/mL, preciso (110,0 %), exato (100,68 %) e robusto. Os métodos microbiológico e cromatográfico validados foram comparados estatisticamente e verificou-se não haver diferença significativa entre eles quando comparados através do teste “t” de Student. No estudo preliminar de estabilidade constatou-se ser estável em hidrólise ácida (0,1 M) e luz UVA no período avaliado, e instável frente à degradação térmica (40 e 60 °C), oxidativa com peróxido de hidrogênio, básica em NaOH (0,1 M e 0,01 M) e luz UVC. As cinéticas de degradação frente à luz UVC e degradação térmica 60 °C mostraram que as amostras possuem cinética de degradação de ordem zero e de segunda ordem, respectivamente. O ensaio de citotoxicidade demonstrou não haver diferença entre a condição normal e a amostra submetida à degradação forçada, sugerindo que os possíveis produtos de degradação formados não alteraram o resultado. / In this work, analytical and microbiological methods were developed and validated, as well as a preliminary study of the stability, degradation kinetics and cytotoxicity to Ceftaroline Fosamil powder for injectable solution, this is a fifth generation cephalosporin antibiotic indicated for community-acquired pneumonia and severe infections of the skin and soft tissues. The validation of the microbial assay by diffusion method in 3x3 cylinder agar delineated showed satisfactory results in specificity, linearity in the range of 2.0 - 8.0 μg / mL, precision (109.42 %), accuracy (102.3 %) and robustness. The development and validation of the method by HPLC was evaluated through specificity, linearity, precision, accuracy and robustness. In the chromatographic method was used high performance liquid chromatograph from SHIMADZU with Agilent® C18 column, mobile phase (water with triethylamine 1.0 % pH 5.0: acetonitrile 87:13 v/v). The method was linear, specific in the range of 5.0 - 60.0 μg/mL, accurate (110.0 %), exact (100.68 %) and robust. The validated microbiological and chromatographic methods were compared statistically and there was no significant difference between them when compared through Student's t-test. In the preliminary stability study, it was found stable in acid hydrolysis (0.1M) and UVA light in the period evaluated, and instable against thermal degradation (40 and 60 °C), oxidative with hydrogen peroxide, basic in NaOH (0.1 M and 0.0 1M) and UVC light. Samples exposed in UVC light an thermal degradation at 60°C showed degradation kinetics following zero order and second order, respectively. The cytotoxicity assay showed no difference between the normal condition and the sample submitted to forced degradation, suggesting that the possible degradation products formed did not change the result.

Made available in DSpace on 2014-10-09T12:33:39Z (GMT). No. of bitstreams: 0 / Made available in DSpace on 2014-10-09T14:04:37Z (GMT). No. of bitstreams: 0 / Tese (Doutoramento) / IPEN/T / Instituto de Pesquisas Energéticas e Nucleares - IPEN-CNEN/SP

CoordenaÃÃo de AperfeÃoamento de Pessoal de NÃvel Superior / A avaliaÃÃo de alteraÃÃes no comportamento do sono em crianÃas com e sem paralisia cerebral por meio de instrumento psicomÃtrico se faz importante, sendo o Infant Sleep Questionnaire (ISQ) um questionÃrio que avalia o relato dos pais sobre o comportamento do sono em crianÃas de 12 a 18 meses. Objetivou-se traduzir, adaptar e validar o ISQ para a versÃo brasileira com cuidadores de crianÃas com e sem paralisia cerebral. Estudo do tipo metodolÃgico, desenvolvido no NÃcleo de Tratamento e EstimulaÃÃo Precoce, no AmbulatÃrio Especializado de Pediatria e no Centro de Desenvolvimento Familiar da Universidade Federal do CearÃ. Seguiu as cinco etapas do processo de adaptaÃÃo transcultural: 1. TraduÃÃo inicial; 2. SÃntese da traduÃÃo; 3. TraduÃÃo de volta ao idioma original; 4. RevisÃo pelo Comità de Especialistas; e 5. Teste da versÃo prÃ-final com 10 cuidadores de crianÃas saudÃveis e com 10 de crianÃas com paralisia cerebral. ApÃs essa fase, o ISQ- versÃo brasileira foi aplicado a 50 cuidadores de crianÃas saudÃveis e 20 cuidadores de crianÃas com PC, totalizando uma amostra de 70 cuidadores. A validade de conteÃdo foi verificada por meio do julgamento de trÃs juÃzes e pelo Ãndice de validade de conteÃdo (IVC). A validade de construto foi analisada pela comparaÃÃo da pontuaÃÃo final do questionÃrio entre os grupos e da associaÃÃo dessa pontuaÃÃo com variÃveis sociodemogrÃficas do cuidador e clÃnicas da crianÃa. Considerou-se o intervalo de confianÃa de 95% (p<0,05) para todos os testes. Os dados foram coletados com o FormulÃrio para CaracterizaÃÃo dos Participantes e o ISQ- versÃo brasileira. O processo de adaptaÃÃo transcultural resultou em um instrumento vÃlido (IVC=0,93). Quanto a comparaÃÃo da pontuaÃÃo do ISQ- versÃo brasileira por grupos de cuidadores, a maioria das mÃdias das questÃes nÃo apresentou diferenÃa estatisticamente significante por grupo, exceto a questÃo cinco (p=0,046). Todavia, a chance da crianÃa com PC apresentar dificuldade para dormir à 2,6 vezes maior do que a da crianÃa saudÃvel e a mÃdia da pontuaÃÃo total do ISQ- versÃo brasileira mostrou-se mais elevada no grupo de cuidadores de crianÃas com PC (13,25), quando comparada a mÃdia do grupo de cuidadores das crianÃas saudÃveis (8,86), sendo essa comparaÃÃo entre as mÃdias estatisticamente significante (p=0,017). A testagem da confiabilidade indicou que os valores do Alpha de Conbrach, Coeficiente de Spearman-Brown e Coeficiente de Guttman Split-Half foram acima de 0,70 e a aplicaÃÃo do teste-reteste por meio do r de Spearman (p<0,001), teste de Wilcoxon (p>0,220) e McNemar (p=1,000) indicaram uma adequada estabilidade entre a primeira e segunda aplicaÃÃo das nove das dez questÃes do questionÃrio. O processo de traduÃÃo e adaptaÃÃo do ISQ-versÃo brasileira resultou em um instrumento adaptado, confiÃvel e vÃlido à lÃngua portuguesa adotada no Brasil. / A avaliaÃÃo de alteraÃÃes no comportamento do sono em crianÃas com e sem paralisia cerebral por meio de instrumento psicomÃtrico se faz importante, sendo o Infant Sleep Questionnaire (ISQ) um questionÃrio que avalia o relato dos pais sobre o comportamento do sono em crianÃas de 12 a 18 meses. Objetivou-se traduzir, adaptar e validar o ISQ para a versÃo brasileira com cuidadores de crianÃas com e sem paralisia cerebral. Estudo do tipo metodolÃgico, desenvolvido no NÃcleo de Tratamento e EstimulaÃÃo Precoce, no AmbulatÃrio Especializado de Pediatria e no Centro de Desenvolvimento Familiar da Universidade Federal do CearÃ. Seguiu as cinco etapas do processo de adaptaÃÃo transcultural: 1. TraduÃÃo inicial; 2. SÃntese da traduÃÃo; 3. TraduÃÃo de volta ao idioma original; 4. RevisÃo pelo Comità de Especialistas; e 5. Teste da versÃo prÃ-final com 10 cuidadores de crianÃas saudÃveis e com 10 de crianÃas com paralisia cerebral. ApÃs essa fase, o ISQ- versÃo brasileira foi aplicado a 50 cuidadores de crianÃas saudÃveis e 20 cuidadores de crianÃas com PC, totalizando uma amostra de 70 cuidadores. A validade de conteÃdo foi verificada por meio do julgamento de trÃs juÃzes e pelo Ãndice de validade de conteÃdo (IVC). A validade de construto foi analisada pela comparaÃÃo da pontuaÃÃo final do questionÃrio entre os grupos e da associaÃÃo dessa pontuaÃÃo com variÃveis sociodemogrÃficas do cuidador e clÃnicas da crianÃa. Considerou-se o intervalo de confianÃa de 95% (p<0,05) para todos os testes. Os dados foram coletados com o FormulÃrio para CaracterizaÃÃo dos Participantes e o ISQ- versÃo brasileira. O processo de adaptaÃÃo transcultural resultou em um instrumento vÃlido (IVC=0,93). Quanto a comparaÃÃo da pontuaÃÃo do ISQ- versÃo brasileira por grupos de cuidadores, a maioria das mÃdias das questÃes nÃo apresentou diferenÃa estatisticamente significante por grupo, exceto a questÃo cinco (p=0,046). Todavia, a chance da crianÃa com PC apresentar dificuldade para dormir à 2,6 vezes maior do que a da crianÃa saudÃvel e a mÃdia da pontuaÃÃo total do ISQ- versÃo brasileira mostrou-se mais elevada no grupo de cuidadores de crianÃas com PC (13,25), quando comparada a mÃdia do grupo de cuidadores das crianÃas saudÃveis (8,86), sendo essa comparaÃÃo entre as mÃdias estatisticamente significante (p=0,017). A testagem da confiabilidade indicou que os valores do Alpha de Conbrach, Coeficiente de Spearman-Brown e Coeficiente de Guttman Split-Half foram acima de 0,70 e a aplicaÃÃo do teste-reteste por meio do r de Spearman (p<0,001), teste de Wilcoxon (p>0,220) e McNemar (p=1,000) indicaram uma adequada estabilidade entre a primeira e segunda aplicaÃÃo das nove das dez questÃes do questionÃrio. O processo de traduÃÃo e adaptaÃÃo do ISQ-versÃo brasileira resultou em um instrumento adaptado, confiÃvel e vÃlido à lÃngua portuguesa adotada no Brasil.