A questionnaire to evaluate the impact of chronic diseases: validated translation and Illness Effects Questionnaire (IEQ) reliability study

INTRODUCTION: Patients' perception about their health condition, mainly involving chronic diseases, has been investigated in many studies and it has been associated to depression, compliance with the treatment, quality of life and prognosis. The Illness Effects Questionnaire (IEQ) is a tool which makes the standardized evaluation of patients' perception about their illness possible, so that it is brief and accessible to the different clinical settings. This work aims to begin the transcultural adaptation of the IEQ to Brazil through the validated translation and the reliability study. METHODS: The back-translation method and the test-retest reliability study were used in a sample of 30 adult patients under chronic hemodialysis. The reliability indexes were estimated using the Pearson, Spearman, Weighted Kappa and Cronbach's alpha coefficients. RESULTS: The semantic equivalence was reached through the validated translation. In this study, the reliability indexes obtained were respectively: 0.85 and 0.75 (p < 0.001); 0.68 and 0.92 (p < 0.0001). DISCUSSION: The reliability indexes obtained attest to the stability of responses in both evaluations. Additional procedures are necessary for the transcultural adaptation of the IEQ to be complete. CONCLUSION: The results indicate the translation validity and the reliability of the Brazilian version of the IEQ for the sample studied.

Options for clinical trials of pre and post-natal treatments for congenital toxoplasmosis

Clinical trials comparing different drug regimens and strategies for the treatment of congenital toxoplasmosis and its clinical manifestations in the liveborn child in different clinical settings should aim at formally evaluating the net benefit of existing treatments and at developing new therapeutic options. Currently, there is no ideal drug for congenital toxoplasmosis; future research should focus on the screening of new active drugs and on their pre-clinical and early clinical development, with a focus on pharmacokinetic/dynamic studies and teratogenicity. For the prenatal treatment of congenital toxoplasmosis, a trial comparing spiramycine to pyrimethamine-sulphadiazine and placebo would allow a formal estimation of the effect of both drugs in infected pregnant women. In newborn children, the net benefit of pyrimethamine-sulphadiazine should also be formally assessed. These trials will be implemented in settings where prenatal screening for Toxoplasma gondii is currently implemented. Trials should be carefully designed to allow for translation to other settings and modelling tools like cost-effectiveness analysis should be used to provide clinicians and founders with the best available evidence to establish recommendations.

Translation, adaptation and validation of the Roland-Morris questionnaire - Brazil Roland-Morris

The purpose of the present study was to translate the Roland-Morris (RM) questionnaire into Brazilian-Portuguese and adapt and validate it. First 3 English teachers independently translated the original questionnaire into Brazilian-Portuguese and a consensus version was generated. Later, 3 other translators, blind to the original questionnaire, performed a back translation. This version was then compared with the original English questionnaire. Discrepancies were discussed and solved by a panel of 3 rheumatologists and the final Brazilian version was established (Brazil-RM). This version was then pretested on 30 chronic low back pain patients consecutively selected from the spine disorders outpatient clinic. In addition to the traditional clinical outcome measures, the Brazil-RM, a 6-point pain scale (from no pain to unbearable pain), and its numerical pain rating scale (PS) (0 to 5) and a visual analog scale (VAS) (0 to 10) were administered twice by one interviewer (1 week apart) and once by one independent interviewer. Spearman's correlation coefficient (SCC) and intraclass correlation coefficient (ICC) were computed to assess test-retest and interobserver reliability. Cross-sectional construct validity was evaluated using the SCC. In the pretesting session, all questions were well understood by the patients. The mean time of questionnaire administration was 4 min and 53 s. The SCC and ICC were 0.88 (P<0.01) and 0.94, respectively, for the test-retest reliability and 0.86 (P<0.01) and 0.95, respectively, for interobserver reliability. The correlation coefficient was 0.80 (P<0.01) between the PS and Brazil-RM score and 0.79 (P<0.01) between the VAS and Brazil-RM score. We conclude that the Brazil-RM was successfully translated and adapted for application to Brazilian patients, with satisfactory reliability and cross-sectional construct validity.

Cell therapy in dilated cardiomyopathy: from animal models to clinical trials

Dilated cardiomyopathy can be the end-stage form and common denominator of several cardiac disorders of known cause, such as hypertensive, ischemic, diabetic and Chagasic diseases. However, some individuals have clinical findings, such as an increase in ventricular chamber size and impaired contractility (classical manifestations of dilated cardiomyopathy) even in the absence of a diagnosed primary disease. In these patients, dilated cardiomyopathy is classified as idiopathic since its etiology is obscure. Nevertheless, regardless of all of the advances in medical, pharmacological and surgical procedures, the fate of patients with dilated cardiomyopathy (of idiopathic or of any other known cause) is linked to arrhythmic episodes, severe congestive heart failure and an increased risk of sudden cardiac death. In this review, we will summarize present data on the use of cell therapies in animal models of dilated cardiomyopathies and will discuss the few clinical trials that have been published so far involving patients affected by this disease. The animal models discussed here include those in which the cardiomyopathy is produced by genetic manipulation and those in which disease is induced by chemical or infectious agents. The specific model used clearly creates restrictions to translation of the proposed cell therapy to clinical practice, insofar as most of the clinical trials performed to date with cell therapy have used autologous cells. Thus, translation of genetic models of dilated cardiomyopathy may have to wait until the use of allogeneic cells becomes more widespread in clinical trials of cell therapies for cardiac diseases.

Particulate bioglass in the regeneration of alveolar bone in dogs: clinical, surgical and radiographic evaluations

Bone loss, either by trauma or other diseases, generates an increasing need for substitutes of this tissue. This study evaluated Bioglass as a bone substitute in the regeneration of the alveolar bone in mandibles of dogs by clinical, surgical and radiological analysis. Twenty-eight adult dogs were randomly separated into two equal groups. In each animal, a bone defect was created on the vestibular surface of the alveolar bone between the roots of the fourth right premolar tooth. In the treated group, the defect was immediately filled with bioglass, while in the control, it remained unfilled. Clinical evaluations were performed daily for a week, as well as x-rays immediately after surgery and at 8, 14, 21, 42, 60, 90 and 120 days post-operative. Most animals in both groups showed no signs of inflammation and wound healing was similar. Radiographic examination revealed a gradual increase of radiopacity in the region of the defect in the control group. In the treated group, initial radiopacity was higher than that of adjacent bone, decreasing until 21 days after surgery. Then it gradually increased until 120 days after surgery, when the defect became undetectable. The results showed that Bioglass integrates into bone tissue, is biocompatible and reduced the period for complete bone regeneration.

Prevalence of periodontal disease in dogs and owners' level of awareness - a prospective clinical trial

Periodontal disease (PD) is widely known among veterinarians for its high prevalence and serious consequences to the dogs. The objective of this study was to assess the occurrence of PD in dogs that live in the micro-region of Viçosa, treated at the Veterinary Hospital of the Federal University of Viçosa (HVT - Hospital Veterinário da Universidade Federal de Viçosa), as well as to assess how aware of this disease dog owners are. In order to do so, all dogs treated at the HVT from March 10th, 2009 to November 30th, 2009, on alternate days, had their oral cavities examined. Medical history data, such as age, type of food, main complaint and owner consent, halitosis, presence of dental calculus, inflammation and gingival recession and tooth loss, were collected. A prevalence of 88.67% was found for PD in dogs referred to the HVT, and 2.67% were referred due to this disease. Of all the owners who participated in the study, 43.83% knew about periodontal disease and of these 17.46% made use of some type of prevention or treatment. Therefore, periodontal disease is highly prevalent and the owners are not aware of the disease. Thus, a dog owner clarification program on periodontal disease is needed in the area where HVT-UFV operates.

Glucosamine and chondroitin sulfate in the repair of osteochondral defects in dogs - clinical-radiographic analysis

Among the proposed treatments to repair lesions of degenerative joint disease (DJD), chondroprotective nutraceuticals composed by glucosamine and chondroitin sulfate are a non-invasive theraphy with properties that favors the health of the cartilage. Although used in human, it is also available for veterinary use with administration in the form of nutritional supplement independent of prescription, since they have registry only in the Inspection Service, which does not require safety and efficacy testing. The lack of such tests to prove efficacy and safety of veterinary medicines required by the Ministry of Agriculture and the lack of scientific studies proving its benefits raises doubts about the efficiency of the concentrations of such active substances. In this context, the objective of this study was to evaluate the efficacy of a veterinary chondroprotective nutraceutical based on chondroitin sulfate and glucosamine in the repair of osteochondral defects in lateral femoral condyle of 48 dogs, through clinical and radiographic analysis. The animals were divided into treatment group (TG) and control group (CG), so that only the TG received the nutraceutical every 24 hours at the rate recommended by the manufacturer. The results of the four treatment times (15, 30, 60 and 90 days) showed that the chondroprotective nutraceutical, in the rate, formulation and administration at the times used, did not improve clinical signs and radiologically did not influence in the repair process of the defects, since the treated and control groups showed similar radiographic findings at the end of the treatments.

Valor preditivo do "Clinical Risk Index for Babies" para o risco de mortalidade neonatal

OBJETIVO: Comparar o valor preditivo do CRIB (Clinical Risk Index for Babies) para o risco de mortalidade neonatal ao peso de nascimento (PN) e idade gestacional (IG). MÉTODO: Numa coorte prospectiva foram estudados, durante o ano de 1996, 71 recém-nascidos admitidos na unidade de terapia intensiva, com PN < 1.500 g e/ou IG < 31 semanas. RESULTADOS: A taxa de mortalidade foi de 29,6%; para PN < 1.000 g ou IG < 29 semanas foi de 60%, enquanto que para o escore de CRIB > 10 foi de 100%. CONCLUSÕES: O escore de CRIB > 10 correspondeu a maiores especificidade e valor preditivo positivo em relação aos demais parâmetros. A área determinada pela "receiver operating characteristic" relativa ao CRIB também foi superior. O CRIB mostrou-se um marcador mais acurado na previsão de risco de mortalidade quando comparado ao PN ou IG isoladamente.

Clinical and laboratory parameters in dapsone acute intoxication

OBJECTIVE: To determine the severity of dapsone (DDS) acute intoxication – an uncommon medical event – using clinical and laboratory parameters. METHODS: Two hundred and seventy four patients with acute DDS intoxication, aged 1 month to 50 years old, were studied and classified into four age groups. Clinical evaluation was assessed through a protocol and correlated with laboratory parameters. Spectrophotometric methods were used to analyze methemoglobinemia (MHbp) and dapsonemia (DDSp). RESULTS: The most prevalent clinical sign of intoxication was cyanosis, seen in 65.7% of the patients and in 100% of children less than 5 years of age. According to laboratory criteria, MHbp-related severe clinical intoxication was seen in 56.2% and DDSp-related occurred in 58% of the patients. Regarding DDSp, intoxication was considered severe when 20 tablets (100 mg each) were ingested, a median of 29 mug/ml. Regarding MHbp, intoxication was severe when 7.5 tablets were ingested, a median of 38% of the total Hb. The correlation between MHbp and DDSp was statistically significant (n=144, r=0.32, p<0.05). Negative correlation was observed between MHbp and the time elapsed since DDS intake (n=124, r=-0.34, p<0.001). There was also a negative correlation between DDSp and the time elapsed since DDS intake (n=63, r=-0.35, p<0.0001). CONCLUSIONS: Longitudinal analysis showed a significant association between methemoglobinemia and the time elapsed after the intake (t), according to the equation: Dapsonemia = 12.9256 - 0.0682t + 0.234 methemoglobinemia

Trypanosoma cruzi prevalence and clinical forms in blood donor candidates in Brazil

The prevalence and clinical forms of Trypanosoma cruzi were evaluated among blood donor candidates attended at a general hospital in Rio de Janeiro, Brazil, from January 1997 to April 1999. The investigation was done by means of the indirect hemagglutination test and was confirmed via ELISA. Data were collected from clinical examinations, conventional electrocardiogram, chest radiography and echocar-diography. The results showed that despite Trypanosoma cruzi prevalence of 1.17% (128 patients), mainly in males aged 40 years or over, 70.8% of these patients, mainly males aged 19 to 39 years, demonstrated abnormalities that allowed the diagnosis of cardiopathy and/or esophagopathy. This once again corroborates the importance of Trypanosoma cruzi infection in urban centers.

Validade da versão em português da Clinical Dementia Rating

OBJETIVO: Analisar a validade da versão em português da Clinical Dementia Rating para classificar a função cognitiva de idosos. MÉTODOS: Utilizou-se o instrumento Mini-Mental State Examination para rastreamento de déficit cognitivo em coorte composta por 424 idosos. Foram selecionados todos que obtiveram escores <26 (108 idosos) e 48 idosos com escores >26. Os 156 idosos selecionados foram submetidos a uma avaliação clínica e testes neuropsicológicos para diagnóstico de casos de demência. Tanto os casos como os não-casos foram classificados segundo a versão em português da Clinical Dementia Rating em: normais, casos questionáveis e casos de demência leve, moderada ou grave. RESULTADOS: Entre os 156 avaliados, 122 eram não-casos, destes 62 (51%) foram classificados como normais (CDR=0) e questionáveis 60 (49%) (CDR=0,5). Entre os 34 casos de demência, 17 (50%) foram classificados como demência leve (CDR=1), 8 (23%) moderada (CDR=2) e 6 (18%) grave (CDR=3). Apenas três (9%) dos casos foram considerados questionáveis pelo Clinical Dementia Rating. Sua sensibilidade foi de 91,2% e a especificidade de 100%, com valor preditivo positivo de 100% e negativo de 97,6%. As pontuações no Mini-Mental State Examination declinaram significativamente conforme o grau de demência. CONCLUSÕES: O Clinical Dementia Rating mostrou ser instrumento válido para classificar o grau de demência entre idosos. Quase metade dos não-casos foram casos questionáveis pelo Clinical Dementia Rating e podem corresponder a casos de transtorno cognitivo leve, com maior risco de conversão em demência.

Clinical and functional aspects of work-related musculoskeletal disorders among active workers

OBJECTIVE: To evaluate musculoskeletal disorders among active industrial workers. METHODS: The study was carried out in São Carlos, Southeastern Brazil, in 2005. One hundred and thirty-four female workers were physically evaluated and answered questions about their physical symptoms, filled out a pain scale and gave responses in the Oswestry Disability Questionnaire, and the Work Ability Index questionnaire. The data were analyzed descriptively, and in correlation tests and through applying logistic regression. The outcome was evaluated in relation to the perceptions of pain, symptoms, physical assessment, ability to work and disability. RESULTS: Clinical evaluations and sick leave presented positive correlations with the subjective variables. The Work Ability Index presented a negative correlation with the physical disability index (r=-0.69). Symptoms reported at the time of the assessment presented a good correlation with the results from the pain scale and the clinical findings. Previous sick leave showed an association with disability (OR=1.13; 95% CI:1.08;1.18). CONCLUSION: Symptom reports and pain scales may be useful for assessing current conditions at the time of evaluating individuals with work-related musculoskeletal disorders, as they are easier to apply. In more severe cases of such injuries, clinical and functional evaluations and questionnaires such as those relating to ability to work and disability are preferable. Precise and specific evaluations of these disorders may contribute towards fairer legal and administrative decisions.

HIV testing and clinical status upon admission to a specialized health care unit in Pará, Brazil

OBJECTIVE To analyze the clinical and laboratory characteristics of HIV-infected individuals upon admission to a reference health care center.METHODS This cross-sectional study was conducted between 1999 and 2010 on 527 individuals with confirmed serological diagnosis of HIV infection who were enrolled in an outpatient health care service in Santarém, PA, Northern Brazil. Data were collected from medical records and included the reason for HIV testing, clinical status, and count of peripheral CD4+ T lymphocytes upon enrollment. The data were divided into three groups, according to the patient’s year of admission – P1 (1999-2002), P2 (2003-2006), and P3 (2007-2010) – for comparative analysis of the variables of interest.RESULTS In the study group, 62.0% of the patients were assigned to the P3 group. The reason for undergoing HIV testing differed between genders. In the male population, most tests were conducted because of the presence of symptoms suggesting infection. Among women, tests were the result of knowledge of the partner’s seropositive status in groups P1 and P2. Higher proportion of women undergoing testing because of symptoms of HIV/AIDS infection abolished the difference between genders in the most recent period. A higher percentage of patients enrolling at a more advanced stage of the disease was observed in P3.CONCLUSIONS Despite the increased awareness of the number of HIV/AIDS cases, these patients have identified their serological status late and were admitted to health care units with active disease. The HIV/AIDS epidemic in Pará presents specificities in its progression that indicate the complex characteristics of the epidemic in the Northern region of Brazil and across the country.

Vocal warm-up and breathing training for teachers: randomized clinical trial

OBJECTIVE To compare the effectiveness of two speech therapy interventions, vocal warm-up and breathing training, focusing on teachers’ voice quality.METHODS A single-blind, randomized, parallel clinical trial was conducted. The research included 31 20 to 60-year old teachers from a public school in Salvador, BA, Northeasatern Brazil, with minimum workloads of 20 hours a week, who have or have not reported having vocal alterations. The exclusion criteria were the following: being a smoker, excessive alcohol consumption, receiving additional speech therapy assistance while taking part in the study, being affected by upper respiratory tract infections, professional use of the voice in another activity, neurological disorders, and history of cardiopulmonary pathologies. The subjects were distributed through simple randomization in groups vocal warm-up (n = 14) and breathing training (n = 17). The teachers’ voice quality was subjectively evaluated through the Voice Handicap Index (Índice de Desvantagem Vocal, in the Brazilian version) and computerized voice analysis (average fundamental frequency, jitter, shimmer, noise, and glottal-to-noise excitation ratio) by speech therapists.RESULTS Before the interventions, the groups were similar regarding sociodemographic characteristics, teaching activities, and vocal quality. The variations before and after the intervention in self-assessment and acoustic voice indicators have not significantly differed between the groups. In the comparison between groups before and after the six-week interventions, significant reductions in the Voice Handicap Index of subjects in both groups were observed, as wells as reduced average fundamental frequencies in the vocal warm-up group and increased shimmer in the breathing training group. Subjects from the vocal warm-up group reported speaking more easily and having their voices more improved in a general way as compared to the breathing training group.CONCLUSIONS Both interventions were similar regarding their effects on the teachers’ voice quality. However, each contribution has individually contributed to improve the teachers’ voice quality, especially the vocal warm-up.TRIAL RECORD NCT02102399, “Vocal Warm-up and Respiratory Muscle Training in Teachers”.

Effects of acupressure on progress of labor and cesarean section rate: randomized clinical trial

OBJECTIVE To analyze the effects of acupressure at the SP6 point on labor duration and cesarean section rates in parturients served in a public maternity hospital.METHODS This controlled, randomized, double-blind, pragmatic clinical trial involved 156 participants with gestational age ≥ 37 weeks, cervical dilation ≥ 4 cm, and ≥ 2 contractions in 10 min. The women were randomly divided into an acupressure, placebo, or control group at a university hospital in an inland city in the state of Sao Paulo, Brazil, in 2013. Acupressure was applied to the SP6 point during contractions for 20 min.RESULTS The average labor duration was significantly different between the SP6 acupressure group [221.5 min (SD = 162.4)] versus placebo [397.9 min (SD = 265.6)] and versus control [381.9 min (SD = 358.3)] (p = 0.0047); however, the groups were similar regarding the cesarean section rates (p = 0.2526) and Apgar scores in the first minute (p = 0.9542) and the fifth minute (p = 0.7218) of life of the neonate.CONCLUSIONS The SP6 acupressure point proved to be a complementary measure to induce labor and may shorten the labor duration without causing adverse effects to the mother or the newborn. However, it did not affect the cesarean section rate.