On the implementation of good manufacturing practices in a small processing unity of mozzarella cheese in Brazil

This study reports the implementation of GMPs in a mozzarella cheese processing plant. The mozzarella cheese manufacturing unit is located in the Southwestern region of the state of Parana, Brazil, and processes 20,000 L of milk daily. The implementation of GMP took place with the creation of a multi-disciplinary team and it was carried out in four steps: diagnosis, report of the diagnosis and road map, corrective measures and follow-up of GMP implementation. The effectiveness of actions taken and GMP implementation was compared by the total percentages of non-conformities and conformities before and after implementation of GMR Microbiological indicators were also used to assess the implementation of GMP in the mozzarella cheese processing facility. Results showed that the average percentage of conformity after the implementation of GMP was significant increased to 66%, while before it was 32% (p < 0.05). The populations of aerobic microorganisms and total coliforms in equipment were significantly reduced (p < 0.05) after the implementation of GMP, as well as the populations of total coliforms in the hands of food handlers (p < 0.05). In conclusion, GMP implementation changed the overall organization of the cheese processing unity, as well as managers and food handlers' behavior and knowledge on the quality and safety of products manufactured. (C) 2011 Elsevier Ltd. All rights reserved.

Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language

The use of patient-orientated questionnaires is of utmost importance in assessing the outcome of spine surgery. Standardisation, using a common set of outcome measures, is essential to aid comparisons across studies/in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders. This study aimed to produce a Brazilian-Portuguese version of the COMI. A cross-cultural adaptation of the COMI into Brazilian-Portuguese was carried out using established guidelines. 104 outpatients with chronic LBP (> 3 months) were recruited from a Public Health Spine Medical Care Centre. They completed a questionnaire booklet containing the newly translated COMI, and other validated symptom-specific questionnaires: Oswestry Disability Index (ODI) and Roland Morris disability scale (RM), and a pain visual analogue scale. All patients completed a second questionnaire within 7-10 days to assess reproducibility. The COMI summary score displayed minimal floor and ceiling effects. On re-test, the responses for each individual domain of the COMI were within 1 category in 98% patients for the domain 'function', 96% for 'symptom-specific well-being', 97% for 'general quality of life', 99% for 'social disability' and 100% for 'work disability'. The intraclass correlation coefficients (ICC2,1) for COMI pain and COMI summary scores were 0.91-0.96, which compared favourably with the corresponding values for the RM (ICC, 0.99) and ODI (ICC, 0.98). The standard error of measurement for the COMI was 0.6, giving a "minimum detectable change" (MDC95%) of approximately 1.7 points i.e., the minimum change to be considered "real change" beyond measurement error. The COMI scores correlated as hypothesised (Rho, 0.4-0.8) with the other symptom-specific questionnaires. The reproducibility of the Brazilian-Portuguese version of the COMI was comparable to that of other language versions. The COMI scores correlated in the expected manner with existing but longer symptom-specific questionnaires suggesting good convergent validity for the COMI. The Brazilian-Portuguese COMI represents a valuable tool for Brazilian study-centres in future multicentre clinical studies and surgical registries.

Ear and electrode effects reduce within-group variability in middle latency response amplitude measures

Objectives: To establish normative amplitude values for relative difference measurements of the middle latency response (MLR) in normal-hearing pediatrics and to determine if these measurements provided a significant reduction of within-group variability when compared to raw, absolute amplitude measures. A relative amplitude difference is defined in the present paper as the difference in Na-Pa amplitude between two electrodes (e.g. vertical bar Na-Pa at C3 minus Na-Pa at C4 vertical bar, or electrode effects) or between two ears (e.g. vertical bar Na-Pa on left ear stimulation minus Na-Pa on right ear stimulation vertical bar, or ear effects). In contrast, an absolute amplitude is defined as a single Na-Pa measurement made at one electrode for stimulation of one ear (e.g. Na-Pa measured at C3 on left ear stimulation). Design: Cross-sectional study. Study sample: 155 pediatrics with normal peripheral and central hearing, and no history of psychological, neurological, or learning disability issues. Results: Within-group variability was significantly smaller for relative differences when compared to absolute amplitude measures. Electrode effects showed significantly less variability than ear effects. Normative values for ear and electrode effects were reported. Conclusions: Relative differences may provide better utility in the clinical diagnosis of central auditory pathology in pediatrics when compared to absolute amplitude measures because these difference measures show significantly lower variability when examined across subjects.

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

Trends of the genetic connectedness measures among Nelore beef cattle herds

Validity of comparisons between expected breeding values obtained from best linear unbiased prediction procedures in genetic evaluations is dependent on genetic connectedness among herds. Different cattle breeding programmes have their own particular features that distinguish their database structure and can affect connectedness. Thus, the evolution of these programmes can also alter the connectedness measures. This study analysed the evolution of the genetic connectedness measures among Brazilian Nelore cattle herds from 1999 to 2008, using the French Criterion of Admission to the group of Connected Herds (CACO) method, based on coefficients of determination (CD) of contrasts. Genetic connectedness levels were analysed by using simple and multiple regression analyses on herd descriptors to understand their relationship and their temporal trends from the 19992003 to the 20042008 period. The results showed a high level of genetic connectedness, with CACO estimates higher than 0.4 for the majority of them. Evaluation of the last 5-year period showed only a small increase in average CACO measures compared with the first 5 years, from 0.77 to 0.80. The percentage of herds with CACO estimates lower than 0.7 decreased from 27.5% in the first period to 16.2% in the last one. The connectedness measures were correlated with percentage of progeny from connecting sires, and the artificial insemination spread among Brazilian herds in recent years. But changes in connectedness levels were shown to be more complex, and their complete explanation cannot consider only herd descriptors. They involve more comprehensive changes in the relationship matrix, which can be only fully expressed by the CD of contrasts.

COMPARISON MEASURES OF MAPS GENERATED BY GEOSTATISTICAL METHODS

This study uses several measures derived from the error matrix for comparing two thematic maps generated with the same sample set. The reference map was generated with all the sample elements and the map set as the model was generated without the two points detected as influential by the analysis of local influence diagnostics. The data analyzed refer to the wheat productivity in an agricultural area of 13.55 ha considering a sampling grid of 50 x 50 m comprising 50 georeferenced sample elements. The comparison measures derived from the error matrix indicated that despite some similarity on the maps, they are different. The difference between the estimated production by the reference map and the actual production was of 350 kilograms. The same difference calculated with the mode map was of 50 kilograms, indicating that the study of influential points is of fundamental importance to obtain a more reliable estimative and use of measures obtained from the error matrix is a good option to make comparisons between thematic maps.

Linear and nonlinear measures of fetal heart rate patterns evaluated on very short fetal magnetocardiograms

We analyzed the effectiveness of linear short- and long-term variability time domain parameters, an index of sympatho-vagal balance (SDNN/RMSSD) and entropy in differentiating fetal heart rate patterns (fHRPs) on the fetal heart rate (fHR) series of 5, 3 and 2 min duration reconstructed from 46 fetal magnetocardiograms. Gestational age (GA) varied from 21 to 38 weeks. FHRPs were classified based on the fHR standard deviation. In sleep states, we observed that vagal influence increased with GA, and entropy significantly increased (decreased) with GA (SDNN/RMSSD), demonstrating that a prevalence of vagal activity with autonomous nervous system maturation may be associated with increased sleep state complexity. In active wakefulness, we observed a significant negative (positive) correlation of short-term (long-term) variability parameters with SDNN/RMSSD. ANOVA statistics demonstrated that long-term irregularity and standard deviation of normal-to-normal beat intervals (SDNN) best differentiated among fHRPs. Our results confirm that short-and long-term variability parameters are useful to differentiate between quiet and active states, and that entropy improves the characterization of sleep states. All measures differentiated fHRPs more effectively on very short HR series, as a result of the fMCG high temporal resolution and of the intrinsic timescales of the events that originate the different fHRPs.

Integrating on-line process control and imperfect corrective maintenance: An economical design

Existing studies of on-line process control are concerned with economic aspects, and the parameters of the processes are optimized with respect to the average cost per item produced. However, an equally important dimension is the adoption of an efficient maintenance policy. In most cases, only the frequency of the corrective adjustment is evaluated because it is assumed that the equipment becomes "as good as new" after corrective maintenance. For this condition to be met, a sophisticated and detailed corrective adjustment system needs to be employed. The aim of this paper is to propose an integrated economic model incorporating the following two dimensions: on-line process control and a corrective maintenance program. Both performances are objects of an average cost per item minimization. Adjustments are based on the location of the measurement of a quality characteristic of interest in a three decision zone. Numerical examples are illustrated in the proposal. (c) 2012 Elsevier B.V. All rights reserved.

Ethnic Influence in Clinical and Functional Measures of Brazilian Patients with Spondyloarthritis

Objective. Spondyloarthritides (SpA) can present different disease spectra according to ethnic background. The Brazilian Registry of Spondyloarthritis (RBE) is a nationwide registry that comprises a large databank on clinical, functional, and treatment data on Brazilian patients with SpA. The aim of our study was to analyze the influence of ethnic background in SpA disease patterns in a large series of Brazilian patients. Methods. A common protocol of investigation was prospectively applied to 1318 SpA patients in 29 centers distributed through the main geographical regions in Brazil. The group comprised whites (65%), African Brazilians (31.3%), and people of mixed origins (3.7%). Clinical and demographic variables and various disease index scores were compiled. Ankylosing spondylitis (AS) was the most frequent disease in the group (65.1%); others were psoriatic arthritis (18.3%), undifferentiated SpA (6.8%), enteropathic arthritis (3.7%), and reactive arthritis (3.4%). Results. White patients were significantly associated with psoriasis (p = 0.002), positive HLA-B27 (p = 0.014), and use of corticosteroids (p < 0.0001). Hip involvement (p = 0.02), axial inflammatory pain (p = 0.04), and radiographic sacroiliitis (p = 0.025) were associated with African Brazilian descent. Sex distribution, family history, and presence of peripheral arthritis, uveitis, dactylitis, urethritis, and inflammatory bowel disease were similar in the 3 groups, as well as age at disease onset, time from first symptom until diagnosis, and use of anti-tumor necrosis factor-a agents (p > 0.05). Schober test and thoracic expansion were similar in the 3 groups, whereas African Brazilians had higher Maastricht Ankylasing Spondylitis Enthesitis Scores (p = 0.005) and decreased lateral lumbar flexion (p = 0.003), while whites had a higher occiput-to-wall distance (p = 0.02). African Brazilians reported a worse patient global assessment of disease (p = 0.011). Other index scores and prevalence of work incapacity were similar in the 3 groups, although African Brazilians had worse performance in the Ankylosing Spondylitis Quality of Life questionnaire (p < 0.001). Conclusion. Ethnic background is associated with distinct clinical aspects of SpA in Brazilian patients. African Brazilian patients with SpA have a poorer quality of life and report worse disease compared to whites, (First Release Nov 1 2011; J Rheumatol 2012;39:141-7; doi:10.3899/jrheum.110372)

Measures of quality of life in children with cochlear implant: systematic review

The use of cochlear implant (CI) in children enables the development of listening and communication skills, allowing the child's progress in school and to be able to obtain, maintain and carry out an occupation. However, the progress after the CI has different results in some children, because many children are able to interact and participate in society, while others develop limited ability to communicate verbally. The need for a better understanding of CI outcomes, besides hearing and language benefits, has spurred the inclusion of quality of life measurements (QOL) to assess the impact of this technology. OBJECTIVE: Identify the key aspects of quality of life assessed in children with cochlear implant. METHOD: Through a systematic literature review, we considered publications from the period of 2000 to 2011. CONCLUSION: We concluded that QOL measurements in children include several concepts and methodologies. When referring to children using CI, results showed the challenges in broadly conceptualizing which quality of life domains are important to the child and how these areas can evolve during development, considering the wide variety of instruments and aspects evaluated.

Comparison measures of maps generated by geostatistical methods

This study uses several measures derived from the error matrix for comparing two thematic maps generated with the same sample set. The reference map was generated with all the sample elements and the map set as the model was generated without the two points detected as influential by the analysis of local influence diagnostics. The data analyzed refer to the wheat productivity in an agricultural area of 13.55 ha considering a sampling grid of 50 x 50 m comprising 50 georeferenced sample elements. The comparison measures derived from the error matrix indicated that despite some similarity on the maps, they are different. The difference between the estimated production by the reference map and the actual production was of 350 kilograms. The same difference calculated with the mode map was of 50 kilograms, indicating that the study of influential points is of fundamental importance to obtain a more reliable estimative and use of measures obtained from the error matrix is a good option to make comparisons between thematic maps.