The Brazilian Portuguese version of the Exercise Adherence Rating Scale (EARS-Br) showed acceptable reliability, validity and responsiveness in chronic low back pain.

BACKGROUND: This study aimed to adapt the Exercise Adherence Rating Scale (EARS) into Brazilian Portuguese and evaluate its measurement properties, given as reliability, validity, and responsiveness in patients with non-specific Chronic Low Back Pain (CLBP). METHODS: A total of 108 patients with a mean age of 46.62 years (SD = 9.98) and CLBP participated in this longitudinal study. Participants were oriented on undertaking the prescribed exercises in the first session, and adherence behavior was assessed after 1 week, and finally reassessed after 2 weeks (test-retest reliability). Three weeks after the first assessment, they were invited again to full fill the EARS (responsiveness). The intraclass correlation coefficient (ICC2,1) and Cronbach's α were used to assess test-retest reliability and internal consistency, respectively. Spearman's correlation and confirmatory factor analysis (CFA) were used to assess construct validity, and the Receiver operating characteristic curve and area under the curve (AUC) were used to analyze responsiveness. RESULTS: The one-factor EARS-Br (adherence behavior) structure with 6 items showed acceptable fit indexes (comparative fit index and goodness of fit index> 0.90 and root-mean-square error of approximation< 0.08). The EARS-Br scale showed acceptable internal consistency (α = 0.88) and excellent reliability (ICC = 0.91 [95% CI 0.86-0.94]). Mild to moderate correlations were observed between EARS-Br total score vs. disability, pain catastrophizing, depression/anxiety, fear-avoidance and pain intensity. A Minimally Important Change (MIC) of 5.5 in the EARS-Br total score was considered as a meaningful change in the adherence behavior (AUC = 0.82). Moderate accuracy (AUC = 0.89) was obtained for a 17/24 total EARS cutoff score after home exercise was prescribed. The sensitivity and specificity were also acceptable (greater than 80%). CONCLUSION: Our results demonstrated acceptable EARS-Br reliability, validity, and responsiveness for patients with CLBP. A final score of 17/24 on EARS after the prescription of home-exercise could be used as a cut-off for an acceptable adherence behavior associated with improvement in patient outcomes.

A new material to prevent urethral damage after implantation of artificial devices: an experimental study.

OBJECTIVE: To validate the application of the bacterial cellulose (BC) membrane as a protecting bar-rier to the urethra. MATERIALS AND METHODS: Forty female Wistar rats (four groups of 10): Group 1 (sham), the urethra was dissected as in previous groups and nothing applied around; Group 2, received a 0.7cm strip of the BC applied around the urethra just below the bladder neck; Group 3, received a silicon strip with the same dimensions as in group 2; Group 4, had a combination of 2 and 3 groups being the silicon strip applied over the cellulosic material. Half of the animals in each group were killed at 4 and 8 months. Bladder and urethra were fixed in formalin for histological analysis. RESULTS: Inflammatory infiltrates were more intense at 4 months at lymphonodes (80% Grade 2), statistically different in the group 2 compared with groups 1 (p=0.0044) and 3 (p=0.0154). At 8 months, all samples were classified as grade 1 indicating a less intense inflammatory reaction in all groups. In group 2, at 8 months, there was a reduction in epithelial thickness (30±1µm) when com-pared to groups 1 (p=0.0001) and 3 (p<0.0001). Angiogenesis was present in groups 2 and 4 and absent in group 3. In BC implant, at 4 and 8 months, it was significant when comparing groups 4 with 1 (p=0.0159). CONCLUSION: BC membrane was well integrated to the urethral wall promoting tissue remodeling and strengthening based on morphometric and histological results and may be a future option to prevent urethral damage.

[Socioeconomic vulnerability and obesity in Chilean schoolchildren attending first grade: comparison between 2009 and 2013]. / Vulnerabilidad socioeconómica y obesidad en escolares chilenos de primero básico: comparación entre los años 2009 y 2013.

INTRODUCTION: Although obesity is related to socioeconomic level, studies are inconclusive. OBJECTIVES: To determine obesity risk according to socioeconomic vulnerability among Chilean children (1st grade) in 2009 and 2013 and assess its change during that period, by sex and geographical area. PATIENTS AND METHOD: Cross-sectional study (N = 175,462 in 2009) and (N = 189,055 in 2013) which included: weight, height, rural / urban, gender and vulnerability obtained from JUNAEB's survey. BMI Z, % obesity and 3 categories of vulnerability (very vulnerable, moderate, non-vulnerable) were determined. For the descriptive analyses, we used t tests and for predictor variables (2 categories of vulnerability) and outcome (obesity) by sex and area, we used %2. Logistic regression models determined OR to develop obesity by. RESULTS: % obesity was 19.6% and 24.1% in 2009 and 2013, higher in boys. In urban and rural areas respectively, OR to develop obesity were: 0.85 (0.82-0.88) and 0.70 (0.64-0.75) in the most vulnerable students and 0.94 (0.91-0.97) and 0.81 (0.74-0.88) in those with moderate vulnerability in 2009 and 0.96 (0.93-0.98) and 0.89 (0.82-0.96) in the most vulnerable students and 0.99 (0.96-1.02) and 0.94 (0.86-1.02) in students with moderate vulnerability in 2013. The highest increase in obesity was observed among the most vulnerable group from rural areas (16, 6 to 24.3%). vulnerability. CONCLUSION: The non-vulnerable group had the highest % obesity. Although the most vulnerable students in rural areas had the lowest obesity risk in both years, the highest increase in obesity during the period, occurred in that group.

Biocompatibility and cutaneous reactivity of cellulosic polysaccharide film in induced skin wounds in rats.

The development of a skin substitute suitable for immediately performing the function of the lost dermis and epidermis could result in a positive impact on the treatment of patients with extensive skin lesions. A biopolymer film was applied to skin wounds to investigate the biocompatibility and cutaneous reaction and to test its activity as a mechanical barrier and conductor in the healing process. Forty Wistar rats of both sexes were used in the present study. Two excisions were performed in the dorsal part of the skin flaps. The polysaccharide film was applied over one of the incisions and other incision was washed with saline. The time spent for complete healing of both lesions was virtually the same in both groups, during 21 days of observation. The film remained attached to the bed of the exposed wound for an average period of 6 days. There were no statistically significant differences with regard to lesion measurement area at assessment times of 2nd, 7th and 14th postoperative days. At day 21, the scar area showed a significant difference (0.0229). After 40 days, all wounds were completely healed. No statistically significant differences were found between the histological parameters assessed in the experimental and control groups. The cellulosic polysaccharide film integrated well with the tissue showing high biocompatibility and low skin reactivity.

Measurement Properties of Two Questionnaires Assessing Fear-Avoidance in Patients With Chronic Low Back Pain.

The Fear-Avoidance Components Scale (FACS) and the Fear of Daily Activities Questionnaire (FDAQ) assess fear-avoidance model components. However, the questionnaires are not available in Brazilian Portuguese. This study aimed to translate the original English FACS and FDAQ into Brazilian (Br) Portuguese and assess their measurement properties in patients with Chronic Low Back Pain (CLBP). One hundred thirty volunteers with CLBP participated in this study. Structural validity, internal consistency, test-retest reliability, and hypothesis testing for construct validity were analyzed. Results indicated a 2-factor solution for the FACS-Br, while the FDAQ-Br had a one-factor solution. Internal consistency showed acceptable Cronbach's alpha (alpha >.8). Suitable reliability was found for the FDAQ-Br (Intraclass Correlation Coefficient [ICC] = .98). For both FACS-Br factors, suitable reliability was found as well (ICC = .95 and .94). Hypothesis testing for construct validity confirmed more than 75% of the hypotheses proposed a priori for the FACS maladaptive pain/movement-related beliefs domain and the FDAQ-Br. In conclusion, the FACS-Br and FDAQ-Br demonstrated acceptable reliability, internal consistency, and structural validity measurement properties and their correlation (r < .50) suggests that the tools are not interchangeable measures.

Molecular detection of vector-borne pathogens in cats tested for FIV and FeLV.

The aim of this study was to detect molecularly vector borne pathogens (VBPs) in domiciled cats tested for Feline immunodeficiency virus (FIV) and Feline leukemia virus (FeLV). Blood samples (n = 119) were analyzed microscopically and molecularly through PCR and sequenced for the detection of the following pathogens: piroplasmids., Bartonella henselae, Cytauxzoon felis, Ehrlichia canis, Leishmania spp., hemotropic Mycoplasma spp., Trypanosoma spp., and Ricketssia spp. Animals were also serological assessed for detection of antibodies against FIV and FeLV. Out of all animals, 20.16% (24/119) tested positive for at least one VBPs at molecular examination. Conversely, no animal resulted positive at microscopic analysis. The most prevalent pathogen was hemotropic Mycoplasma haemofelis (8.40%; 10/119), followed by Candidatus Mycoplasma haemominutum (5.88%; 7/119), E. canis (5.04%; 6/119), C. felis (0.84%; 1/119) and B. henselae (0.84%; 1/119). One animal (0.84%; 1/119) was co-infected with. E. canis and B. henselae. A total of 5.88% (7/119) and 1.68% (2/119) tested positive for FIV and FeLV, respectively. Data of this study demonstrate that owned cats can be at risk of hemotropic Mycoplasma spp., E. canis, C. felis and B. henselae. Therefore, preventive measures against vectors of these pathogens should be implemented in order to reduce the risk of exposition and consequently infection. Additionally, aggressive behaviors among cats should be avoided, especially because hemotropic Mycoplasma spp. may be transmitted through the bite of animals.

Obesity risk in 10-year-old children, based on attributes observed at 4 years of age, provides evidence on how to target interventions to lower obesity rates in mid-childhood.

Introduction: Introduction: although in Chile 75 % of obese preschool children participate in a primary health intervention, obesity rates have increased. Objective: to determine the risk of children being obese in 5th grade (10 yrs), according to biological and social attributes observed when they attended prekindergarten (PK) at 4 yrs, to determine which preschoolers should be prioritized for targeting. Method: a retrospective cohort study including 55,623 participants. The variables collected when children attended PK were age, sex, weight, height, maternal educational level and employment status, the child´s relationship with persons living at home, person in charge of the child after school, and number of household members, plus weight, height, and age in 5th grade. To determine the risk of being obese in 5th grade we did two logistic regression models-the first one included all PK children and the above variables, while the second model considered additionally the presence of obesity in PK. The rest of the variables were the same. Results: the risk of children being obese in 5th grade (10 yrs) was 1.43 times higher if their mothers had ≤ 8 yrs of schooling, 1.13 times higher if they lived with a grandparent, and slightly higher if their mothers had an occupation (1.04 times). Boys had a significantly higher risk (1.74 times). Obesity at 4 yrs constituted the highest obesity risk later on (5.3 times). Conclusions: targeting obese 4-year-old boys who participate in a primary health intervention, whose mothers have low education and who live with a grandparent, may lower obesity rates in mid-childhood.

Introducción: Introducción: aunque, en Chile, el 75 % de los preescolares obesos participan en un programa de salud primaria, la obesidad infantil ha aumentado. Objetivo: determinar el riesgo de obesidad en escolares de 5º básico (10 años), según las características biológicas y sociales observadas en prekínder (PK) a los 4 años, para determinar qué preescolares debieran ser priorizados para intervenir. Método: cohorte retrospectiva de 55.623 participantes. Las variables recolectadas en PK fueron: edad, sexo, peso, estatura, nivel educacional y situación laboral de la madre, relación del preescolar con miembros del hogar, persona que cuida al escolar y número de miembros del hogar, además de peso, estatura y edad en 5º básico. El riesgo de obesidad en 5º básico se determinó a través de 2 modelos de regresión logística: el primero incluyó a todos los preescolares en PK y las variables mencionadas anteriormente, y el segundo consideró adicionalmente la presencia de obesidad en PK. El resto de las variables fueron las mismas. Resultados: el riesgo de que los escolares presenten obesidad en 5º básico (10 años) fue 1,43 veces mayor si sus madres tenían ≤ 8 años de escolaridad, 1,13 veces mayor si vivían con un abuelo y ligeramente mayor si sus madres estaban ocupadas (1,04 veces). Los hombres tenían un riesgo significativamente mayor (1,74 veces). La obesidad a los 4 años constituyó el mayor riesgo de obesidad posteriormente (5,3 veces). Conclusión: centrar la atención en los niños obesos de 4 años que participen en una intervención de atención primaria, cuyas madres tengan menor educación y que vivan con un abuelo podría reducir la prevalencia de la obesidad.

Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial.

BACKGROUND: Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (e.g., provocative cognitive, movement, and lifestyle behaviors). METHODS: To investigate the efficacy of CFT compared with a sham intervention for pain intensity and disability post-intervention (immediately after the last session) in patients with non-specific chronic low back pain (CLBP). This study is a randomized controlled trial in which 152 (18-60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive (1) CFT intervention or (2) sham intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of the participants. The sham group will attend six sessions: consisting of 30 min of photobiomodulation using a detuned device and more than 15 min of talking about neutral topics. Patients from both groups also will receive an educational booklet (for ethical reasons). Participants will be assessed pre and post-intervention, 3 months, and 6 months after randomization. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement, and functioning post-intervention, 3-, and 6-month follow-up. The patients and the assessor will be blinded to the treatment administered (active vs. sham). STATISTICAL ANALYSIS: The between-group differences (effects of treatment), as well as the treatment effect for the primary and secondary outcomes, and their respective 95% confidence intervals will be calculated by constructing linear mixed models. DISCUSSION: To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04518891 . First Posted: August 19, 2020.

Patient-Reported Outcome Measurements in Temporomandibular Disorders and Headaches: Summary of Measurement Properties and Applicability.

INTRODUCTION: Several patient-reported outcome measurements (PROMs) are available in the literature to support the evaluation and diagnosis of temporomandibular disorders and headaches. However, clinicians and researchers usually complain that they had no education on PROMs and low overall knowledge about PROMs. OBJECTIVE: This study aimed to summarize, describing the measurement properties and clinical applicability of the main condition-specific PROMs available in the literature to the assessment of patients with Temporomandibular Disorders and Headaches. METHODS: The current manuscript reviewed 10 PROMs commonly used in the field. Four instruments about functioning and disability: 1. Mandibular Function Impairment Questionnaire (MFIQ), 2. Craniofacial Pain and Disability Inventory (CF-PDI), 3. 8-item and 20-item Jaw Functional Limitation Scale (JFLS), and 4. Manchester Orofacial Pain Disability Scale (MOPDS). Two instruments about headache-related disability: 5. Headache-Related Disability Index (HDI) and 6. Headache Impact Test-6 (HIT-6). Three instruments focused on TMD and headache screening: 7. 3Q/TMD, 8. Short-Form Anamnestic Fonseca Index (SFAI), 9. Headache Screening Questionnaire. In addition, one instrument about maladaptive beliefs regarding pain and injury: 10. Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD). CONCLUSIONS: The knowledge about the limitations and applicability of the PROMs commonly used to assess TMDs and Headaches can help clinicians and researchers to obtain reliable and valid outcomes to support the decision-making process. The current review recognizes the importance of using patient-reported outcome measures in research and clinical practice. However, our findings call the attention that further studies on the measurement properties of such instruments are imperative.

Injectable semi rigid penile prosthesis: study in rabbits and future perspectives.

BACKGROUND: Penile prostheses are the third option in the treatment of erectile dysfunction, however, despite their proven effectiveness, the occurrence of infections, advanced age of patients and comorbidities are the main limiting factors for this treatment modality. In the continuous search for biointegrated, clinically durable and minimally invasive treatment options, a possible model of penile prosthesis was sought through the use of intracavernous bacterial cellulose (BC) gel, in an experimental model of orchiectomized rabbits. METHODS: Thirty adult New Zealand rabbits were equally distributed into three groups: BC; vehicle and control. Each group was then subdivided according to the follow-up time of 3 and 6 months. Bilateral orchiectomy was performed 3 weeks before injection in the BC and vehicle groups. Pachymetry measurements of the penile axis, diameter and length were performed in situ. Histomorphometry analyzes of the corpora cavernosa (CC), thickness of the tunica albuginea, cell density, collagen and elastic fibers post-injection were also performed, in addition to immunohistochemistry for newly formed vessels. RESULTS: The implant of BC increased both the length and thickness of the penis three and six months after the last injection, with a consequent increase in the diameter of the CC. On the other hand, the filling effect was not observed in the control and vehicle groups, confirming the degradation of this tissue after orchiectomy and the effectiveness of BC as a filling agent. Histomorphometry analyzes corroborate the mass effect of BC integrated into the tissue, permeated by predominantly lymphomononuclear inflammatory infiltrate, multinucleated giant foreign body cells, fibroblasts, elastic fibers and newly formed vessels, without degradation or loss of volume, even after six months of implantation. CONCLUSIONS: Biocompatibility and biointegration to the host tissue make BC a prosperous penile filling material, with local application and minimally invasive.

The Prevalence of Adenoid Hypertrophy among Children with Zika Related Microcephaly.

Upper respiratory obstruction is a common sequela in children with Zika-related microcephaly (ZRM). As a cross-sectional analysis nested in a cohort study, this study aims to investigate the prevalence of adenoid hypertrophy (AH) in children with ZRM and symptoms of respiratory obstruction. The data were collected in the first three years of life from children with ZRM who were followed in two reference centers for otorhinolaryngological care of patients with congenital Zika syndrome. Out of 92 children with confirmed ZRM, 57 were evaluated by nasopharyngoscopy after presenting with upper respiratory obstruction symptoms. In this study, 31 of the 57 (54%) children with ZRM who were evaluated had obstructive AH. Thirteen children with obstructive AH were submitted to surgery, which resulted in the complete resolution of symptoms for 11, partial resolution in 1, and no improvement in 1. No evidence of direct involvement by Zika virus (ZIKV) infection in the adenoid tissues was demonstrated by histology or immunohistochemistry. Our results suggest that there is a high prevalence and early presentation of AH in children with ZRM, with consequent upper airway obstruction causing upper airway obstructive disorder, secretory otitis media, and dysphagia.

Demographic, Social and Health-Related Variables that Predict Normal-Weight Preschool Children Having Overweight or Obesity When Entering Primary Education in Chile.

We determined which variables are predictive of normal-weight (N) Chilean 4-year-olds developing overweight/obesity when entering primary school. This study used national data of preschoolers (PK, age 4) in 2011 through 2015, and the same children in the first grade (1st G, age 6) in 2013 through 2017. We formed longitudinal cohorts considering PK as the baseline and 1st G as the follow-up and included anthropometric, socio-demographic, and health variables in PK and anthropometry in the 1st G. We report the percentage N who remained N at follow-up (N-N) or gained excessive weight (N-OW) and (N-OB), by sex. We ran univariate logistic regressions to determine for each variable, its association with gaining excessive weight (N-OW + OB), incorporating significant variables (p < 0.001) in multivariate logistic regression. A total of 483,509 (251,150 girls) of PK had anthropometry in the 1st G. In PK, 22% of the children were obese; in the 1st G (24.8% and 19.7% in boys and girls, respectively). Of normal-weight children, 30% developed OW + OB. The predictive variables were: Being born macrosomic, attending a very vulnerable school, being indigenous, the mother's low schooling, and the child being cared for by the grandmother after school. In this study, the factors predicting that normal-weight preschoolers gain excessive weight gain in a short period of time are mostly related to poverty. Prevention should focus on this population.

Multiple diagnoses, increased kinesiophobia? - Patients with high kinesiophobia levels showed a greater number of temporomandibular disorder diagnoses.

OBJECTIVES: The aim of this study was to empirically derive subgroups according to pain-related fear of movement beliefs using cluster analysis within a sample of TMD patients and asymptomatic volunteers. METHODS: 129 volunteers participated in this cross-sectional study (34.78, standard deviation [SD]: 12.49 years; 92 TMD patients and 37 symptom-free volunteers). Mechanical pain sensitivity through pressure pain threshold (PPT) on orofacial and remote sites, kinesiophobia, pain catastrophizing, anxiety and depression were assessed. A cluster analysis was used to derive subgroups according to kinesiophobia scores (TSK/TMD). RESULTS: Three subgroups were derived: cluster 1 (high kinesiophobia [n = 53], TSK score: 33, SD[standard deviation] = 2.9), cluster 2 (moderate kinesiophobia [n = 50], TSK score: 26.2, SD = 2.14) and cluster 3 (no/low kinesiophobia [n = 26], TSK score 12.12, SD = 2.08) which included patients with higher overall PPT and lower scores on psychosocial variables. The group with high kinesiophobia showed high levels of pain catastrophizing, anxiety, and orofacial pain-related disability compared to the other subgroups and mechanical pain hyperalgesia in remote site compared to the low-kinesiophobia group. Also, we found a greater prevalence of triple diagnosis for the high-kinesiophobia subgroup compared to the moderate kinesiophobia group - odds ratio: 12.6 (95% confidence interval [CI]: 3.31-43.52, p < 0.01). CONCLUSION: These results suggested that patients with TMD and higher levels of kinesiophobia beliefs may show a more complex clinical feature, with high psychosocial distress, widespread mechanical pain sensitivity, and a more complex TMD disorder. In this way, we suggest a relationship between the number of TMD diagnoses and kinesiophobia severity.

How to determine the quality of a questionnaire according to the CONsensus-based Standards for the selection of health Measurement INstruments? A simplified guide to the measurement properties of assessment instruments - Part II: validity, responsiveness, interpretability and a checklist for characterizing the quality of instruments / Como determinar a qualidade de um questionário de acordo com o COnsensus-based Standards for the selection of health Measurement INstruments? Um guia simplificado sobre as propriedades de medida de instrumentos de avaliação - Parte II: validade, responsividade, interpretabilidade e checklist para caracterização da qualidade dos instrumentos

ABSTRACT BACKGROUND AND OBJECTIVES: The type of questionnaire that aims to capture a patient's perception/view of an aspect to be measured (e.g. pain intensity) is called Patient Reported Outcome Measure (PROM). One of the biggest challenges that clinicians and researchers often face is making a decision about which PROM to use for the assessment of their patient with pain, especially due to the lack of scientific literacy needed to understand the criteria and terms used in the field of measurement properties. Thus, the objectives of this study (part II) were: (I) to introduce basic concepts about PROMs with a focus on the terminology and criteria defined by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and (2) to describe the measurement properties of the validity, responsiveness and interpretability domains and propose a checklist for assessing the quality of PROMs' measurement properties. METHODS: This study was produced using a search for articles from the COSMIN initiative. For didactic purposes, the text was divided into two parts. RESULTS: This article included a description of the measurement properties of the validity (content, structural, construct), responsiveness (must be assessed through accuracy analyses, AUC≥0.70) and interpretability (which provides the minimum clinically important change) domains. In addition, a checklist was proposed for determining the quality of the measurement properties of assessment instruments. CONCLUSION: This study described the measurement properties within the validity and responsiveness domains, and the importance of interpretability for obtaining the minimum clinically important difference. The proposed checklist for evaluating these properties can help clinicians and researchers to determine the quality of an instrument and make a decision about the best option available.

RESUMO JUSTIFICATIVA E OBJETIVOS: O tipo de questionário que pretende captar a percepção/visão de um paciente sobre um aspecto a ser medido (ex: intensidade da dor) é chamado de Instrumento de Medida Baseado no Relato do Paciente (Patient Reported Outcome Measure - PROM). Um dos maiores desafios que clínicos e pesquisadores costumam enfrentar é quanto a tomada de decisão sobre qual PROM utilizar para a avaliação de seu paciente com dor, especialmente devido à falta do letramento científico necessário para entender os critérios e termos empregados na área de propriedades de medida. Assim, os objetivos deste estudo (parte II) foram: (I) introduzir conceitos básicos sobre PROMs com enfoque na terminologia e critérios definidos através do COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), e (2) descrever as propriedades de medida dos domínios validade, responsividade e interpretabilidade e propor um checklist para avaliação da qualidade das propriedades de medida de PROMs. MÉTODOS: Utilizando uma busca voltada para os artigos da iniciativa COSMIN, foi elaborado o presente estudo de revisão, que foi dividido em duas partes para fins didáticos. RESULTADOS: O presente artigo compreendeu a descrição das propriedades de medida dos domínios de validade (conteúdo, estrutural, construto), responsividade (deve ser avaliada através de análises de acurácia, AUC≥0,70) e interpretabilidade (que fornece a mínima mudança clinicamente importante). Além disso, foi proposto um checklist para determinação da qualidade das propriedades de medida de instrumentos de avaliação. CONCLUSÃO: Este estudo descreveu as propriedades de medida dentro dos domínios validade e responsividade, e a importância da interpretabilidade para a obtenção da mínima diferença clinicamente importante. O checklist proposto para avaliação dessas propriedades pode auxiliar clínicos e pesquisadores a determinarem a qualidade de um instrumento e tomar a decisão sobre a melhor opção disponível.

Bacterial cellulose to reinforce urethrovesical anastomosis. A translational study.

PURPOSE: To evaluate the efficacy of the cellulosic exopolysaccharide membrane (CEM) as a urethral reinforcement for urethrovesical anastomosis. METHODS: Twenty eight rabbits were submitted to urethrovesical anastomosis with or without CEM reinforcement. The animals were divided into 4 groups: C7, CEM7, C14 and CEM14: (C= only anastomosis or CEM = anastomosis + CEM), evaluated after 7 weeks, and 14 weeks. The biointegration and biocompatibility of CEM were evaluated according to stenosis, fistula, urethral wall thickness, urethral epithelium, rate of inflammation and vascularization. RESULTS: Between the two experimental groups, the difference in the number of stenosis or urinary fistula was not statistically significant. The morphometric analysis revealed preservation of urethral lumen, well adhered CEM without extrusion, a controlled inflammatory process and implant vascularization. The urothelium height remained constant over time after CEM reinforcement and the membrane wall was thicker, statistically, after 14 weeks. CONCLUSION: The absence of extrusion, stenosis or urinary fistula after 14 weeks of urethrovesical anastomosis demonstrates cellulosic exopolysaccharide membrane biocompatibility and biointegration with tendency to a thicker wall.

Proton nuclear magnetic resonance-based metabonomic models for non-invasive diagnosis of liver fibrosis in chronic hepatitis C: Optimizing the classification of intermediate fibrosis.

AIM: To develop metabonomic models (MMs), using 1H nuclear magnetic resonance (NMR) spectra of serum, to predict significant liver fibrosis (SF: Metavir ≥ F2), advanced liver fibrosis (AF: METAVIR ≥ F3) and cirrhosis (C: METAVIR = F4 or clinical cirrhosis) in chronic hepatitis C (CHC) patients. Additionally, to compare the accuracy of the MMs with the aspartate aminotransferase to platelet ratio index (APRI) and fibrosis index based on four factors (FIB-4). METHODS: Sixty-nine patients who had undergone biopsy in the previous 12 mo or had clinical cirrhosis were included. The presence of any other liver disease was a criterion for exclusion. The MMs, constructed using partial least squares discriminant analysis and linear discriminant analysis formalisms, were tested by cross-validation, considering SF, AF and C. RESULTS: Results showed that forty-two patients (61%) presented SF, 28 (40%) AF and 18 (26%) C. The MMs showed sensitivity and specificity of 97.6% and 92.6% to predict SF; 96.4% and 95.1% to predict AF; and 100% and 98.0% to predict C. Besides that, the MMs correctly classified all 27 (39.7%) and 25 (38.8%) patients with intermediate values of APRI and FIB-4, respectively. CONCLUSION: The metabonomic strategy performed excellently in predicting significant and advanced liver fibrosis in CHC patients, including those in the gray zone of APRI and FIB-4, which may contribute to reducing the need for these patients to undergo liver biopsy.

Effect of sugarcane biopolymer in vocal fold of rabbits. Comparative study with calcium hydroxyapatite.

PURPOSE: To compare the inflammatory reaction caused by the injection of a sugarcane biopolymer (SCB) into the vocal fold of rabbits with that caused by calcium hydroxyapatite (CaH). METHODS: CaH (Radiesse(r)) and SCB gel were injected respectively into the right and left vocal cords of thirty rabbits. The rabbits were distributed into two equal groups and sacrificed at three and twelve weeks after injection. We then evaluated the intensity of the inflammatory reaction, plus levels of neovascularization, fibrogenesis and inflammatory changes in the vocal mucosa. RESULTS: The vocal cords injected with CaH had a stronger inflammatory reaction by giant cells in both study periods. The SCB group had a more intense inflammatory involvement of polymorphonuclear cells three weeks after injection. SCB caused a higher level of neovascularization compared with CaH three weeks after the procedure. CONCLUSION: Whereas calcium hydroxyapatite triggers a more intense and lasting inflammatory reaction mediated by giant cells, sugarcane biopolymer causes a greater response from polymorphonuclear leukocytes, as well as higher levels of vneoascularization three weeks after injection.

Biocompatibility of the bacterial cellulose hydrogel in subcutaneous tissue of rabbits.

PURPOSE: To evaluate the biocompatibility and local sensibility reaction to bacterial cellulose hydrogel (0.8%) implanted in subcutaneous tissue of rabbits. METHODS: Fifteen New Zeland rabbits were randomly allocated into three groups: T1, 7 days, T2, 21 days, and T3, 84 days. The new material was implanted in the subcutaneous tissue of the ear; on the scalp over the periosteum; and on the outer and inner surfaces of the thighs, in the aponeurosis of the muscle. At 7, 21 and 84 postoperative days, the material was collected for histological study. The clinical signs, inflammatory response, angiogenesis and fibrogenesis were variables used for analysis of the biocompatibility and biological reactivity to BCH. Analyses were performed with an AXIO(r) Imager. The statistical tests were performed using the GraphPad Prism 5.0 program(r) RESULTS: The intensity of the inflammatory infiltrate, considering the different cell types (PMN, LMN and GC), was statistically significant, with group T1 different from groups T2 and T3 (p = 0.0124 and p <0.0001, respectively) and T2 different from the T3 group (p = 0.0007). Fibrogenesis grade 1 was the most prevalent in groups T1 (55.4%) and T2 (44.6%). The formation of neovascularization in the group was identified in 84.4% of samples. CONCLUSION: Bacterial cellulose hydrogel (0.8%) is biocompatible, integrating with the subcutaneous tissue of rabbits and inducing tissue remodeling.

The Biocompatibility of a Cellulose Exopolysaccharide Implant in the Rabbit Bladder When Compared With Dextranomer Microspheres Plus Hyaluronic Acid.

OBJECTIVE: To evaluate biocompatibility of a cellulosic exopolysaccharide (CEC) as bulking agent in rabbit urinary bladder. MATERIALS AND METHODS: The experimental study was developed at the Nucleus for Experimental Surgery or UFPE. The new agent was injected into the bladder of the adult rabbits using a small abdominal incision. Animals were injected with 0.2 mL of dextranomer microspheres (Dx) plus hyaluronic acid and CEC. The animals were studied after 3 days (G1), 90 days (G2), and 11 months (G3). The biocompatibility was evaluated according to the histologic parameters (presence of blood vessels, inflammatory reaction, and collagen deposition) by a quantitative analysis. The Student paired t test was used for continuous variables, and the scores were compared through the chi-square test. RESULTS: Both materials were structurally homogeneous and free from inflammatory cells or blood vessels (G1). In 3-month samples (G2), CEC areas were densely invaded by fibroblasts and blood vessels. Dx areas were fragmented but still homogeneous and free from cells or blood vessels. Samples from 3 and 11 months showed a significant difference in favor of CEC especially concerning preservation of material in the implant site, as well as the presence of neovascularization. This experimental study represents a positive outcome in terms of reflux resolution in the long term. Further studies may be necessary to confirm its efficacy when in clinical use. CONCLUSION: The CEC exhibited low inflammatory response and integrated with the host tissue better than Dx in the long-term follow-up.