999 resultados para validação analítica


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O regime eólico de uma região pode ser descrito por distribuição de frequências que fornecem informações e características extremamente necessárias para uma possível implantação de sistemas eólicos de captação de energia na região e consequentes aplicações no meio rural em regiões afastadas. Estas características, tais como a velocidade média anual, a variância das velocidades registradas e a densidade da potência eólica média horária, podem ser obtidas pela frequência de ocorrências de determinada velocidade, que por sua vez deve ser estudada através de expressões analíticas. A função analítica mais adequada para distribuições eólicas é a função de densidade de Weibull, que pode ser determinada por métodos numéricos e regressões lineares. O objetivo deste trabalho é caracterizar analítica e geometricamente todos os procedimentos metodológicos necessários para a realização de uma caracterização completa do regime eólico de uma região e suas aplicações na região de Botucatu - SP, visando a determinar o potencial energético para implementação de turbinas eólicas. Assim, foi possível estabelecer teoremas relacionados com a forma de caracterização do regime eólico, estabelecendo a metodologia concisa analiticamente para a definição dos parâmetros eólicos de qualquer região a ser estudada. Para o desenvolvimento desta pesquisa, utilizou-se um anemômetro da CAMPBELL.

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As disfunções temporomandibulares (DTM) representam a maior causa de dor não dentária da região orofacial. Dada sua alta prevalência na população em geral e a existência de inúmeros instrumentos diagnósticos não padronizados, buscou-se elaborar e validar um questionário simples, de acessibilidade ampla e aplicação prática, com vistas a contribuir para o diagnóstico e o estudo epidemiológico das mesmas. A estratégia utilizada na montagem do instrumento foi estabelecida com base na avaliação criteriosa de questionários já existentes na literatura, validação de expertos na área de DTM, validação fatorial, de face (na primeira fase do estudo) e, frente ao padrão ouro (RDC/TMD), na segunda fase do estudo. Na primeira fase, participaram 160 indivíduos. A consistência interna resultou num Coeficiente Alfa de Cronbach de 0,752 para o questionário com sete itens; enquanto que para o questionário com cinco itens, este resultado foi de 0,694, não sendo o mesmo, considerado baixo por avaliar apenas cinco questões e ainda, em razão do tema central da pesquisa ser bastante subjetivo. A análise fatorial confirmatória apontou para uma variância total dos fatores extraídos do questionário com sete itens, de 58,2 % e do questionário com cinco itens de 70,04%. Portanto, o questionário com cinco questões, apresentou resultados estatísticos superiores ao de sete questões. Na validação frente ao padrão ouro (RDC/TMD), foram avaliados 99 indivíduos tendo sido testados os dois questionários, com sete e com cinco questões. Na estrutura com sete questões, ao se categorizar as mesmas por totais de pontos obtidos, em quatro condições, obteve-se o melhor resultado quando se considerou com DTM a faixa entre 10 e 21 pontos, sendo 85,1% positivos também no RDC/TMD, com acurácia de 90,1% e Kappa 0,817. Nesta condição, a sensibilidade encontrada foi de 95% (IC 95%, 91 a 99), especificidade de 87% (IC 95%, 81 a 93), VPP 85%, VPN 96%, LR+ 7,3 e LR- 17,4. Quando os dados foram avaliados para o questionário com cinco questões (QST/DTM), pode-se observar que o melhor ponto de corte foi quando se considerou como portadores de DTM, os indivíduos na faixa entre 7 e 15 pontos, com acurácia de 85,8% e Kappa 0,817. Nesta condição, a sensibilidade foi 88% (IC 95%, 81,6 a 94,4), especificidade 84% (IC 95%, 76,8 a 91,2), VPP 80%, VPN 90,5%, LR+ 5,5 e LR- 7,0. A simplicidade do presente questionário (QST/DTM) com apenas cinco questões, possibilita seu uso como elemento de triagem inicial na área da dor orofacial em disfunção temporomandibular, com boa compreensibilidade, confiabilidade, reprodutibilidade e possibilidade de aplicação em pesquisas epidemiológicas. Concluiu-se que o questionário aqui validado, permite sua aplicação de forma simples tanto por profissionais e pesquisadores da Odontologia como de outras áreas da saúde

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The measurement of patient satisfaction can provide information about the success of the care provider in reaching the values and meeting the expectations of the patient. The purpose of this study was to translate into the Portuguese language and to culturally customize to the Brazilian population the instrument to measure patient satisfaction with physical therapy elaborated by Goldstein et al. The study sample was made up of 279 patients who were undergoing physical therapy treatment at 39 different private clinics in a middle-sized town in northeastern Brazil. For the translation of the survey instrument, the back-translation technique was employed, in association with the bilingual method. The reliability and validity of the Brazilian version of the instrument were both assessed. Reliability analysis, carried out with the computation of Cronbach alpha coefficients, showed that the measures obtained with the instrument have a high degree of internal consistency. The aspects dealing with the patient therapist relationship are the most important predictors of satisfaction, followed by those dealing with courtesy, privacy, and practical aspects such as efficiency of the facility in the patient admissions process, setting up of appointments, and waiting time in waiting room. Items dealing with aspects such as location of the facility and availability of parking facilities may underestimate the reliability of the instrument. This study translated, culturally customized, and validated an instrument to measure patient satisfaction with physical therapy originally developed in English. By so doing, this study has made this instrument available to the Brazilian society, and it has rendered it a useful parameter that can be utilized in our country in the field of physical therapy

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The herbal medicine Sanativo® is produced by the Pernambucano Laboratory since 1888 with indications of healing and hemostasis. It is composed of a fluid extract about Piptadenia colubrina, Schinus terebinthifolius, Cereus peruvianus and Physalis angulata. Among the plants in their composition, S. terebinthifolius and P. colubrina have in common phenolic compounds which are assigned most of its pharmacological effects. The tannins, gallic acid and catechin were selected as markers for quality control. The aim of this study was the development and validation of analytical method by HPLC/UV/DAD for the separation and simultaneous quantification of gallic acid (GAC) and catechin (CTQ) in Sanativo®. The chromatographic system was to stationary phase, C-18 RP column, 4,6 x 150 mm (5 mm) under a temperature of 35 ° C, detection at 270 and 210 nm. The mobile phase consisted of 0.05% trifluoroacetic acid and methanol in the proportions 88:12 (v/v), a flow rate of 1 ml/min. The analytical method presented a retention factor of 0.30 and 1.36, tail factor of 1.8 and 1.63 for gallic acid and catechin, respectively, resolution of 18.2, and theoretical plates above 2000. The method validation parameters met the requirements of Resolution n º 899 of May 29, 2003, ANVISA. The correlation coefficient of linear regression analysis for GAC and CTQ from the standard solution was 0.9958 and 0.9973 and when performed from the Sanativo® 0.9973 and 0.9936, the matrix does not interfere in the range 70 to 110 %. The limits of detection and quantification for GAC and CQT were 3.25 and 0.863, and 9.57 and 2.55 mg/mL, respectively. The markers, GAC and CQT, showed repetibility (coefficient of variation of 0.94 % and 2.36 %) and satisfactory recovery (100.02 ± 1.11 % and 101.32 ± 1.36 %). The method has been characterized selective and robust quantification of GAC and CTQ in the Sanativo® and was considered validated

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Kalanchoe brasiliensis Cambess (Crassulaceae), commonly known as saião , coirama branca , folha grossa , is originally from Brazil and commonly found in São Paulo to Bahia, mainly in the coastal zone. Regarding of biological activities, most preclinical studies were found in the literature, mainly about the anti-inflammatory activity of extracts obtained from leaves and / or aerial parts of K. brasiliensis. As regards the chemical constitution, it has been reported mainly the presence of flavonoids in the leaves of the species, but until this moment did not knows which are the active compounds. Although it is a species widely used in traditional medicine in Brazil, there is no monograph about the quality parameters of the plant drug. In this context, this study aims to characterize and quantify the chemical markers of hydroethanolic extract (HE) from the leaves of K. brasiliensis, which can be used in quality control of plant drug and derivatives obtained from this species. The methodology was divided into two parts: i. Phytochemical study: to fractionate, isolate and characterizate of the chemical (s) marker (s) of the HE from the leaves of K. brasiliensis; ii. To Developed validate of analytical method by High Performance Liquid Chromatography (HPLC)-diode array detector (DAD) to quantify the chemical (s) marker (s) of the EH. i. The EH 50% was prepared by turbo extraction method. It was then submitted to liquid-liquid partition, obtaining dichloromethane, n-butanol and ethyl acetate (AcOEt) fractions. The AcOEt fraction was selected to continue the fractionation process, because it has a chemical profile rich in flavonoids. The acOEt fraction was submitted to column chromatography using different systems for obtaining the compound Kb1. To identify this compound, it was submitted to UV analysis ii. For quantitative analysis, the EH was analyzed by HPLC, using different methods. After selecting the most appropriate method, which showed satisfactory resolution and symmetrical peaks, it was validated according to parameters in the RE 899/2003. As result, it was obtained from the AcOEt fraction the compound Kb1 (2.7 mg). Until this moment, the basic nucleus was characterized by UV analysis using shift reagents. The partial chemical structure of the compound Kb1 was identified as a flavonol, containing hydroxyls in 3 , 4 position (ring A), 5 and 7 free (ring B) and a replacement of the C3 hydroxyl by a sugar. As the analysis were performed in the HPLC coupled to a DAD, we observed that the UV spectrum of the major peaks of EH from K. brasiliensis shown similar UV spectrum. According to the literature, it has been reported the presence of patuletin glycosydes derivatives in the leaves of this species. Therefore, it is suggested that the compound Kb1 is glycosylated patuletin derivative. Probably the sugar (s) unit(s) are linked in the C3 in the C ring. . Regarding the development of HPLC analytical method, the system used consists of phase A: water: formic acid (99,7:0,3, v / v) and phase B: methanol: formic acid (99,7:0,3, v / v), elution gradient of 40% B - 58% B in 50 minutes, ccolumn (Hichrom ®) C18 (250x4, 0 mm, 5 μm), flow rate 0.8 mL / min, UV detection at 370 nm, temperature 25 ° C. In the analysis performed with the co-injection of thecompound Kb1 + HE of K. brasiliensis was observed that it is one of the major compounds with a retention time of 12.47 minutes and had a content of 15.3% in EH of leaves from K. brasiliensis. The method proved to be linear, precise, accurate and reproducible. According to these results, it was observed that compound Kb1 can be used as a chemical marker of EH from leaves of K. brasiliensis, to assist in quality control of drug plant and its derivatives

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Tuberculosis is a serious disease, but curable in practically 100% of new cases, since complied the principles of modern chemotherapy. Isoniazid (ISN), Rifampicin (RIF), Pyrazinamide (PYR) and Chloride Ethambutol (ETA) are considered first line drugs in the treatment of tuberculosis, by combining the highest level of efficiency with acceptable degree of toxicity. Concerning USP 33 - NF28 (2010) the chromatography analysis to 3 of 4 drugs (ISN, PYR and RIF) last in average 15 minutes and 10 minutes more to obtain the 4th drug (ETA) using a column and mobile phase mixture different, becoming its industrial application unfavorable. Thus, many studies have being carried out to minimize this problem. An alternative would use the UFLC, which is based with the same principles of HPLC, however it uses stationary phases with particles smaller than 2 μm. Therefore, this study goals to develop and validate new analytical methods to determine simultaneously the drugs by HPLC/DAD and UFLC/DAD. For this, a analytical screening was carried out, which verified that is necessary a gradient of mobile phase system A (acetate buffer:methanol 94:6 v/v) and B (acetate buffer:acetonitrile 55:45 v/v). Furthermore, to the development and optimization of the method in HPLC and UFLC, with achievement of the values of system suitability into the criteria limits required for both techniques, the validations have began. Standard solutions and tablets test solutions were prepared and injected into HPLC and UFLC, containing 0.008 mg/mL ISN, 0.043 mg/mL PYR, 0.030 mg.mL-1 ETA and 0.016 mg/mL RIF. The validation of analytical methods for HPLC and UFLC was carried out with the determination of specificity/selectivity, analytical curve, linearity, precision, limits of detection and quantification, accuracy and robustness. The methods were adequate for determination of 4 drugs separately without interfered with the others. Precise, due to the fact of the methods demonstrated since with the days variation, besides the repeatability, the values were into the level required by the regular agency. Linear (R> 0,99), once the methods were capable to demonstrate results directly proportional to the concentration of the analyte sample, within of specified range. Accurate, once the methods were capable to present values of variation coefficient and recovery percentage into the required limits (98 to 102%). The methods showed LOD and LOQ very low showing the high sensitivity of the methods for the four drugs. The robustness of the methods were evaluate, facing the temperature and flow changes, where they showed robustness just with the preview conditions established of temperature and flow, abrupt changes may influence with the results of methods

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A mancha preta dos citros é uma doença causada pelo fungo Guignardia citricarpa que produz lesões em frutos em variedades de laranja doce comerciais, causando a queda precoce dos frutos, diminuindo a produtividade e levando a sua depreciação para o mercado de fruta fresca. O objetivo do trabalho foi desenvolver e validar um modelo de favorabilidade climática da mancha preta dos citros relacionado a ocorrência dos sintomas da doença no Estado de São Paulo. Desenvolveu-se um sistema empírico com base em um banco de dados da ocorrência da doença e das condições climáticas, em campo, nos municípios de Barretos/SP e Gavião Peixoto/SP, durante as Safras 2007/2008 e 2008/2009. A variedade de laranjeira doce utilizada nos experimentos foi a 'Valência' enxertada sobre limoeiro 'Cravo', com 10 anos de idade. Para a incidência da mancha preta foi avaliada a porcentagem de frutos com sintomas na planta e para a severidade, a porcentagem de casca lesionada por fruto. Na análise de regressão as variáveis climáticas e os dados de intensidade de doença de Barretos foram selecionados no procedimento 'stepwise'. As melhores equações de regressão foram selecionadas pelo coeficiente de determinação (R²) e pela significância da regressão no teste F (P < 0,05 e P < 0,01) que resultou na equação Y= -502,43 + 9,61 X10 + 4,78 X30 + 0,54 X46 - 7,9 X50 em que Y=Índice de Favorabilidade, X10 é a temperatura média, X30 é a umidade relativa média, X46 é o molhamento foliar e X50 é a temperatura média durante o molhamento foliar, determinados com dados de intervalos de sete dias. Procedeu-se a validação no campo no município de Gavião Peixoto durante a Safra 2008/2009, realizando a correlação entre a incidência e severidade observadas no experimento e os dados previstos que foram os determinados pela equação, sendo que a correlação mostrou-se positiva para a incidência da doença com um R²=0,87.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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To mesure the human performance is a challenge, mainly due to the multidimensional factor movement. Instruments, mostly only assess one dimension of it. Objective: To develop a prototype capable of measuring the skills of human performance and check its validity using method comparison approach. Methods: The study was divided into two stages. The first Prototype was developed and tested simultaneously with an instrument to study the Rectilinear Uniform Motion and Uniformly Miscellaneous. In the second phase the sample consisted of Paralympic basketball athletes (n=09) and karate athletes (n=31) and all agreed to the terms of participation in the research. The evaluation of performance measures was performed with the prototype, the results obtained were compared with the data calculated by a statistical package is used as a reference. Results: All variables calculated by the prototype showed no significant differences when compared with the results calculated by the reference instrument and statistical package. Conclusion: The prototype has been developed and the results obtained in laboratory and field indicate that the prototype can be used for measuring human performance measures, with immediate results without the need for a conventional computer return, provided they fulfill the criteria described

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People with venous ulcers constitute as an important public health problem, its treatment is onerous and require assistance provided by trained professionals, systematized through protocols, however what lies in the assistance is that the management of this group of people differs from that preconized in the scientific literature, interfering with wound healing and quality of life of affected. In this sense, the construction of a assistance protocol specific to people with venous ulcers (VU) can help professionals of the Family Health Strategy both in patient assessment as and in establishment of quality assistance. Thus, this study aimed to analyse the validity of a multiprofessional assistance protocol for people with venous ulcers in primary care by health professionals using Delphi technique. This is a quantitative study, the methodological type conducted in two steps: first step related to integrative literature review to subsidize the development of the protocol, then these aspects were organized and proposed to the judges of the study through the Delphi technique. The study was initiated after approval by the Research Ethics Committee. The first step was performed between August and September 2012, in the virtual library of health, in the page of the Coordination of Improvement of Higher Education Personnel, of Municipal Health Secretariat and international guidelines of associations and in the subsequent step carried out between September 2012 to January 2013, was performed search by Lattes platform of the National Council of Technological and Scientific Development, in order to identify health professionals in Brazil who act as judges of the instrument and then, via online, the form was submitted to them.The sample for the second step was 51 judges in the first round and 35 for the second round Delphi. The analysis was done by adopting Kappa index ≥ 0.81 and Content Validity Index (CVI)> 0.80. In the first submission for the judges, items that did not reach Kappa and CVI established were: request / realization / test results, demographic data, medical history, risk factors, verification of pain / vital signs / pulse / infection signs / lesion location/ edema and pain treatment. After removal of items which have not obtained Kappa or CVI index established, it was found achieving optimal levels of these index for the categories. In the next step was the ressubmissão of protocol to judges through the Delphi technique in it was found that, of the 15 categories of the protocol, 12 presented higher scores in Delphi 2 phase and the other three categories remained the same Kappa and IVC of the previous phase. As for the average of evaluation requirements of the protocol was found that the scores assigned by the judges were higher in the second phase in nine of the 10 items, remaining the same in only one of the items indicating validity of the instrument before the consensus of the judges. Thus, we accepted the alternative hypothesis in this study, as they were obtained in the second Delphi phase the validity index greater than or equal to the Delphi 1 phase. The formulation of this assistance protocol valid and reproducible will enable a reorganization and redesign of assistance, with standardization of actions and continuity of care for persons with venous ulcers in primary health care

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O objetivo deste trabalho foi identificar novos marcadores microssatélites, ligados ao gene Rpp5 de resistência à ferrugem-da-soja, e validar os marcadores previamente mapeados, para que possam ser utilizados em programas de seleção assistida por marcadores moleculares (SAM). Para tanto, uma população F2 com 100 indivíduos, derivada do cruzamento entre a PI 200526 e a cultivar Coodetec 208, suscetível à ferrugem, foi artificialmente infectada e avaliada quanto à sua reação de resistência à ferrugem. Marcadores microssatélites foram testados nos genitores e em dois bulks contrastantes, para a identificação de marcadores ligados. Dois novos marcadores, potencialmente associados à resistência, foram testados em plantas individuais, e se constatou que eles estão ligados ao gene Rpp5 e estão presentes no grupo de ligação N da soja. A eficiência de seleção foi determinada em relação a todos os marcadores ligados ao gene Rpp5, e a combinação entre os marcadores Sat_275+Sat_280 foi de 100%.

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This study aimed to validate the contents of an Instrument for Nursing Consultation in the Home Visit of people with Spinal Cord Injury (INCEVDOP-LM), based on the Self-Care Deficit Theory. The methodological development study was conducted with spinal cord injured (SCI) people ascribed in the Family Health Units the city of Natal/RN/Brazil, and with the nurses of these institutions. The study was conducted from Januray 2012 to January 2013 in two phases: the first aimed to identify the need for self-care of persons with SCI, and the second to develop and validate the INCEVDOP-LM. The first phase consisted of a census study of people with SCI living in Natal/RN. In the second phase, a non-probabilistic convencience sample of subjects was selected to form two groups: First stage - Group 1 of the first stage was comprised by 73 adults with SCI diagnosed with paraplegia or tetraplegia, with cognitive function preserved and that were registered to some family health unit; Group 2 of the Second phase was composed of six experts that were nurses with doctoral formation, scientific experience in the area of technology development or assistance to persons with SCI, and with publications in periodicals Qualis A2. Data collection of the first phase was conducted through home visits of people with SCI that responded three instruments: Questionnaire I (comprised of demographic and socioeconomic variables), The Competency Rating Scale for Self-care (ASA) and the Barthel Index (an instrument for evaluation of functional capacity). The research for the second phase was conducted in two stages: I-construction of the INCEVDOP LM; II-validation of the INCEVDOP-LM. The instrument and an evaluation form were forwarded to the experts for the validation. The correlations between the responses were analyzed by the Kappa test, with accepting values of>0.75. The evaluation criteria were: organization, clarity, simplicity, readability, appropriateness of vocabulary, objectivity, accuracy, reliability and suitability and the positive responses with frequency values of≥90% were considered excellent. The chi-square test was used to investigate the differences between proportions. The study attended to the principles of Human Rights CNS Resolution 196/96. Results were reported by means of four articles derived from the study. The findings indicate that the items that showed disagreement among experts (k=0.02) were diagnoses, interventions and evaluation of the nursing features pertaining to the domains of Nutrition, Hygiene, Elimination, Physical, Social and Psychological, and of the Ability to perform work activities feature. Agreement among the experts were reported for the other items, with kappa ranging from 0.72 to 1. After removing items with disagreement, all criteria achieved excellent rates and no significant differences were observed between the proportions of responses of evaluation of experts (p>0.05). We conclude that the instrument shows validity to serve as a guide for nurses to conduct a systematic consultation during the home visit to people with spinal cord injury, with emphasis on self-care. The instrument must go through other levels of validation when applied in the clinical setting

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A pesquisa teve como objetivo elaborar e validar um instrumento para sistematizar a assistência de enfermagem à puérpera no âmbito da atenção básica. O documento foi construído com base na Teoria das Necessidades Humanas Básicas de Horta, na Padronização de um Conjunto Internacional de Dados Essenciais em Enfermagem e na Nomenclatura de diagnósticos e intervenções de enfermagem desenvolvida a partir dos resultados da Classificação Internacional para as Práticas de Enfermagem. Trata-se de um estudo do tipo metodológico desenvolvido em cinco etapas: identificação dos indicadores empíricos relativos à puérpera mediante revisão integrativa da literatura; avaliação dos indicadores empíricos e sua relação com as necessidades humanas básicas por grupo focal com cinco enfermeiras especialistas; estruturação do instrumento mediante a categorização dos indicadores; validação de forma e conteúdo do instrumento pelos especialistas, por meio da técnica Delphi; e aplicação e desenvolvimento das afirmativas de diagnóstico e intervenções de enfermagem. A coleta de dados da primeira etapa ocorreu nos meses de janeiro a março de 2013 nas bases de dados Scopus, Cinahl, Pubmed, Cochrane, e no periódico Journal of Midwifery and Women s Health. A segunda, terceira e quarta etapas se realizaram nos meses de maio a outubro de 2013. Participaram doze e sete especialistas na primeira e segunda rodada de avaliação respectivamente. A seleção dos especialistas ocorreu pela Plataforma Lattes mediante os seguintes critérios de inclusão: ser enfermeiro (a) docente e especialista em enfermagem obstétrica. A consulta a estes profissionais se deu via email e, ao aceitarem participar da pesquisa, assinaram um Termo de Consentimento Livre e Esclarecido. A pesquisa obteve aprovação da Comissão de Ética em Pesquisa da Universidade Federal do Rio Grande do Norte, sob o protocolo nº 184.241 e Certificado de Apresentação para Apreciação Ética nº 11674112.3.0000.5537. Para análise dos dados da primeira etapa, utilizou-se a estatística descritiva e os resultados apresentados em forma de tabelas. Nesta etapa, identificou-se 97 indicadores empíricos e, quando relacionados com as necessidades humanas básicas, 46 desses encontravam-se nas necessidades psicobiológicas, 51 nas psicossociais e 01 nas necessidades psicoespirituais. Com relação à segunda e terceira etapas, os dados passaram por um processo de categorização e análise pelo Índice de Validade de Conteúdo. Os indicadores obtiveram um índice de validação de 100%. Na parte de avaliação da puérpera, os itens não validados foram excluídos do instrumento. Os demais itens obtiveram índice acima de 70%, sendo, portanto, o instrumento validado. O instrumento para a consulta de enfermagem é constituído de dados de identificação da puérpera, dados de avaliação das necessidades humanas da puérpera e itens do cuidado de enfermagem. Na versão final foram selecionados 73 Diagnósticos de Enfermagem e 155 Intervenções de Enfermagem a partir da categorização dos indicadores empíricos validados na segunda e terceira etapas do estudo. Com a conclusão do estudo, o enfermeiro disporá de um instrumento para sistematização da assistência à puérpera na atenção básica. Além disso, o documento servirá como ferramenta para o ensino e a pesquisa em enfermagem obstétrica

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Venous ulcers are lesions resulting from chronic venous insufficiency, venous valvular abnormalities and venous thrombosis. Its occurrence has been growing with the increase in life expectancy of the world population. Considered as fundamental aspects in the approach to the person with venous ulcer care with the interdisciplinary approach, adoption of protocol-specific knowledge, technical skill, coordination between levels of care complexity of the Health System and active participation of patients and their families, a holistic perspective. The construction of a clinical protocol for people with venous ulcers can help professionals of high complexity services in patient assessment and the establishment of quality care in a systematic way and focused on the factors that interfere with wound healing. Thus, this study aimed to analyze the evidence of validation of a clinical protocol for people with venous ulcers treated at high-complexity services. This is a methodological study with a quantitative approach, developed in three stages: literature review, evidence of content validity and evidence of validation in the clinical context. Approved by the Federal University of Rio Grande do Norte Research Ethics Committee (Opinion: 147.452 and CAAE: 07556312.0.0000.5537). The literature review was conducted in August and September 2012, becoming the basis for the construction of the protocol. Then the evidence of content validity, which included 53 judges (experts) selected by the Lattes platform to evaluate the protocol items was performed. The judges were contacted by e-mail and rated the protocol via Google Docs . After analyzing the ratios obtained in this step, which reported kappa between 0.75 and 0.96 and between 0.80 and 0.98 IVC, and the suggestions of the judges, the protocol was adjusted and subjected to empirical evidence to validate the clinical setting at the University Hospital Onofre Lopes in Natal / RN. Evidence of validation in the clinical setting involved 4 judges who acted in pairs (paired) evaluated 32 patients with venous ulcers in the clinical context of high complexity. In both stages, we used the Kappa Index and Content Validity Index to analyze the responses of the judges. The parameters set as acceptable for these indices were: Kappa ≥ 0.61 and Content Validity Index > 0.80. Any evidence of content validity, as evidence of validation in the clinical context, the protocol items that have not reached Kappa and Content Validity Index established indices were excluded and some items were modified or added after suggestions. The process of content validation evidence and evidence of validation in the clinical setting allowed the improvement of the protocol for the care of people with venous ulcers initially proposed. The initial version of the protocol, built from the literature, contained 15 categories and 108 items; after evidence of content validity, remained the reduction to 15 categories with 91 items; the final version, clinically validated, is composed of the same 15 categories, 76 items. The protocol was validated in its content and in the clinical aspect, so we accepted the alternative hypothesis in the study. This protocol may contribute to the care system, allowing tailor behaviors and promote greater resolution in the treatment of people with venous ulcers in health services of high complexity

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Conselho Nacional de Desenvolvimento Científico e Tecnológico