Validation of criteria for nosocomial use of amikacin in Brazil with the Delphi technique

The Delphi technique has been used since the 1950s to collect the opinions of experts; to gauge their indications, and in some instances, to develop a consensus. This systematic collection and aggregation of informed judgments from a group of experts on specific questions or issues is a highly efficient and cost-effective means to establish guidelines and policies, when compared to other strategies, such as committee meetings or personal interviews. OBJECTIVE: Examine the content validation process of the proposed criteria of the American Society of Health System Pharmacists (ASHP) for amikacin use in hospital settings. MATERIAL AND METHODS: The Delphi technique was applied using the proposed ASHP criteria questionnaire containing 102 specific questions related to the nosocomial use of amikacin by individual patients. The questionnaire contained six groups of questions: 1) Identification and basic demographic data, 2) Relevant data for the use of amikacin, 3) Justification of its usage, 4) Critical parameters of amikacin use, 5) Complications, 6) Measurement of results. Eight hospital specialist medical doctors were selected, including five in the area of infectious diseases, one surgeon, one nephrologist and one in critical care medicine. The questionnaire was e-mailed to the doctors and they were asked for their opinion about the appropriateness of the questions. They were to say whether the general concept seemed totally or partially adequate to the proposed process, what grade (0 to 10) they would give to each section, and if there were any perceived deficiencies, they could add, omit or modify individual questions. A second questionnaire containing the questions for which there had been no consensus based on the answers to the previous one was re-sent to the participants for consolidation. RESULTS: Feedback revealed an agreement of 75 percent concerning the utility and appropriateness of sections 1 and 2. The section about the justification of amikacin usage was agreed on by 50 percent. There was a total agreement of 62 percent for the critical parameters of amikacin use, and a partial agreement of 37 percent. The complication of usage of the questionnaire was agreed upon by 50 percent of the participants, and positive measurement of the results was totally agreed on by 62 percent, and partially by 37 percent. The overall score for the questionnaire was 8.77 ± 0.25. CONCLUSION: The usage criteria for amikacin recommended by ASHP were validated by the Delphi technique for utilization in Brazilian hospital settings. The Delphi technique applied to validate a questionnaire instrument for monitoring the correct use of a specific strategic antibiotic indicated for the treatment and prophylaxis of serious antibiotic-resistant Gram-negative bacteria, proved to be a reliable and simple tool for designing guidelines and a consensus document for hospital use of antibiotics.

Validation of criteria for nosocomial use of amikacin in Brazil with the Delphi technique.

UNLABELLED: The Delphi technique has been used since the 1950s to collect the opinions of experts; to gauge their indications, and in some instances, to develop a consensus. This systematic collection and aggregation of informed judgments from a group of experts on specific questions or issues is a highly efficient and cost-effective means to establish guidelines and policies, when compared to other strategies, such as committee meetings or personal interviews. OBJECTIVE: Examine the content validation process of the proposed criteria of the American Society of Health System Pharmacists (ASHP) for amikacin use in hospital settings. MATERIAL AND METHODS: The Delphi technique was applied using the proposed ASHP criteria questionnaire containing 102 specific questions related to the nosocomial use of amikacin by individual patients. The questionnaire contained six groups of questions: 1) Identification and basic demographic data, 2) Relevant data for the use of amikacin, 3) Justification of its usage, 4) Critical parameters of amikacin use, 5) Complications, 6) Measurement of results. Eight hospital specialist medical doctors were selected, including five in the area of infectious diseases, one surgeon, one nephrologist and one in critical care medicine. The questionnaire was e-mailed to the doctors and they were asked for their opinion about the appropriateness of the questions. They were to say whether the general concept seemed totally or partially adequate to the proposed process, what grade (0 to 10) they would give to each section, and if there were any perceived deficiencies, they could add, omit or modify individual questions. A second questionnaire containing the questions for which there had been no consensus based on the answers to the previous one was re-sent to the participants for consolidation. RESULTS: Feedback revealed an agreement of 75% concerning the utility and appropriateness of sections 1 and 2. The section about the justification of amikacin usage was agreed on by 50%. There was a total agreement of 62% for the critical parameters of amikacin use, and a partial agreement of 37%. The complication of usage of the questionnaire was agreed upon by 50% of the participants, and positive measurement of the results was totally agreed on by 62%, and partially by 37%. The overall score for the questionnaire was 8.77 +/- 0.25. CONCLUSION: The usage criteria for amikacin recommended by ASHP were validated by the Delphi technique for utilization in Brazilian hospital settings. The Delphi technique applied to validate a questionnaire instrument for monitoring the correct use of a specific strategic antibiotic indicated for the treatment and prophylaxis of serious antibiotic-resistant Gram-negative bacteria, proved to be a reliable and simple tool for designing guidelines and a consensus document for hospital use of antibiotics.

Comparative study of Hepatitis C virus genotypes 1 and 3 in Salvador, Bahia

Hepatitis C virus displays a high degree of genetic mutation, with considerable heterogeneity, motivating clinical and biomolecular investigations. It is necessary to understand the effects of genotypes on the course of the disease, as well as their peculiarities at the regional level. OBJECTIVE: The study objective was to compare epidemiological, biochemical and histological aspects of hepatitis C virus genotypes 1 and 3 in Salvador, Bahia. STUDY DESIGN: Data were collected retrospectively from outpatient medical records. MATERIALS AND METHODS: 127 patients with positive anti-HCV results were selected, based on detectable RNA-HCV (RT-PCR) of genotypes 1a, 1b and 3a. RESULTS: Thirty-nine (30.7 percent) individuals were infected by subtype 1a, 45 (35.4 percent) by subtype 1b and 43 (33.9 percent) by subtype 3a. Most (73.2 percent) patients were male, with an average age of 47.8 years. The subtype 1b-infected patients had the highest average age (512 ±11.17; P=0.09). The use of illicit injected drugs was more frequent among subtype 3a infected individuals when compared with genotype 1 (6/43; 14 percent and 3/84; 3.6 percent, respectively; P=0,06). No significant differences were found for other epidemiological characteristics. Average values for GT, AST, ALT and ferritin did not differ between the groups (64, 78, 109, 276, respectively). Thyroid dysfunction occurred in 7/30 (23.3 percent) of those infected by genotype 3 (P=0.05). Cryoglobulinemia was also more frequent in this group (5/13, 38 percent, P=0.02). Most patients presented limited necro-inflammatory activity, stages 2 and 3 by the METAVIR Classification. In some cases, dissociation was noticed between inflammatory activity and fibrosis. No significant differences were found in the histopathological findings of the various genotypes. Younger patients had a significantly smaller degree of necrosis in stomatocytosis (P=0.032) and fibrosis (P=0.012). Intense parenchymatous activity and lymphoid follicles were more frequent among alcohol consumers (P=0.06 and P=0.04, respectively). CONCLUSIONS: In Bahia, genotype 3 dissemination seems to be associated with illicit drug use. The disease evolution depends on a function of complex interactions between virus and host. Age and alcohol consumption stand out as important variables in the development of cirrhosis.

Comparative study of hepatitis C virus genotypes 1 and 3 in Salvador, Bahia Brazil.

UNLABELLED: Hepatitis C virus displays a high degree of genetic mutation, with considerable heterogeneity, motivating clinical and biomolecular investigations. It is necessary to understand the effects of genotypes on the course of the disease, as well as their peculiarities at the regional level. OBJECTIVE: The study objective was to compare epidemiological, biochemical and histological aspects of hepatitis C virus genotypes 1 and 3 in Salvador, Bahia. STUDY DESIGN: Data were collected retrospectively from outpatient medical records. MATERIALS AND METHODS: 127 patients with positive anti-HCV results were selected, based on detectable RNA-HCV (RT-PCR) of genotypes 1a, 1b and 3a. RESULTS: Thirty-nine (30.7%) individuals were infected by subtype 1a, 45 (35.4%) by subtype 1b and 43 (33.9%) by subtype 3a. Most (73.2%) patients were male, with an average age of 47.8 years. The subtype 1b-infected patients had the highest average age (512 +/-11.17; P=0.09). The use of illicit injected drugs was more frequent among subtype 3a infected individuals when compared with genotype 1 (6/43; 14% and 3/84; 3.6%, respectively; P=0,06). No significant differences were found for other epidemiological characteristics. Average values for GT, AST, ALT and ferritin did not differ between the groups (64, 78, 109, 276, respectively). Thyroid dysfunction occurred in 7/30 (23.3%) of those infected by genotype 3 (P=0.05). Cryoglobulinemia was also more frequent in this group (5/13, 38%, P=0.02). Most patients presented limited necro-inflammatory activity, stages 2 and 3 by the METAVIR Classification. In some cases, dissociation was noticed between inflammatory activity and fibrosis. No significant differences were found in the histopathological findings of the various genotypes. Younger patients had a significantly smaller degree of necrosis in stomatocytosis (P=0.032) and fibrosis (P=0.012). Intense parenchymatous activity and lymphoid follicles were more frequent among alcohol consumers (P=0.06 and P=0.04, respectively). CONCLUSIONS: In Bahia, genotype 3 dissemination seems to be associated with illicit drug use. The disease evolution depends on a function of complex interactions between virus and host. Age and alcohol consumption stand out as important variables in the development of cirrhosis.

Comparative study of bacterial infection prevalence between cirrhotic patients with and without upper gastrointestinal bleeding.

Bacterial infection is a frequent complication in patients with chronic liver disease, mainly during the advanced stages. There is evidence that the main factors that contribute to a predisposition to infection in cirrhotic patients are related to hepatic failure with consequent immunodeficiency. Invasive procedures (diagnostic or therapeutic) can predispose to bacterial infections, and upper gastrointestinal bleeding (UGB) is considered a potentially important risk factor. A group of cirrhotic patients (child B and C Pugh groups) were evaluated retrospectively by chart reviews regarding the prevalence of bacterial infection during hospitalization to determine whether UGB was a risk factor. An infection was considered present if a specific organ system was identified or if fever (> 38(o)C) persisted for more than 24 hours with associated leukocytosis. Spontaneous bacterial peritonitis was based on classical criteria. Eighty-nine patients were evaluated. Fourty-six patients presented with UGB, and 43 patients had no UGB (control). There were infections recorded in 25/46 (54%) patients with UGB, and 15/43 (35%) in those without UGB (p=0.065). The ratio of the number of infections/admitted patients, was significantly larger in the group with UGB (0.78 +/- 0.89 vs. 0.39 +/- 0.62; p=0.028) since patients had more than one infection. In the UGB group compared to non UGB group, ascites was more frequent (67% vs. 42%; p=0.027); they were more likely to have undergone endoscopic procedures (p<0.001) and the mean +/- SD for platelets count was smaller (96,114 +/- 57,563 vs 145,674 +/- 104,083; p=0.007). The results show that UGB is an important contribution to bacterial infection among Child B and C cirrhotic patients.

Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs.

Children with an uncomplicated femoral fracture, treated with superimposition of fragments and intentional shortening, usually develop overgrowth of the fractured femur and the ipsilateral tibia which may compensate for the initial shortening and enable the limb in question to reach a length similar to that on the normal side. The overgrowth is evaluated clinically and by scanography. The increased metabolic activity of the growth plates that support this overgrowth has not been documented by any laboratory method. In order to evaluate the metabolic activity of the growth plates, 18 patients (11 males, seven females; mean age 6.1 years) with fractures of the femur were studied at three different time intervals (2-5 months, 6-12 months and 18-24 months). Three-phase bone scintigraphy was performed in all patients. Ten children (five males, five females; mean age 7.5 years) who had had bone imaging for other reasons were used as the control group. Visual analysis of the flow and equilibrium phases was performed for the distal femoral and proximal tibial growth plates. Visual and semi-quantitative analyses of the delayed images were performed for the distal femoral and proximal and distal tibial growth plates. Semi-quantitative analyses yielded the following activity ratios: (a) the distal femoral growth plate of the fractured femur to the contralateral one (FR); (b) the proximal growth plate of the tibia on the side of the fractured femur to the contralateral one (TpR); (c) the distal growth plate of the tibia on the side of the fractured femur to the contralateral one (TdR); and (d) in the control group, the distal growth plates of both femora (FCG) and the proximal (TCGp) and distal (TCGd) growth plates of the tibiae. Visual analysis of the blood flow, equilibrium and delayed images showed increased activity in the distal femoral growth plates during the first and second time intervals, but not during the third. No significant activity changes were found in the proximal and distal tibial growth plates during any of the phases analysed. The mean and standard deviation for FR in the three time intervals were: FRI=1.22+/-0.27, FRII=1.17+/-0.16 and FRIII=1.09+/-0.20. FR values were significantly higher than in the control group (FCG=0.99+/-0.03) (P=0.033). The mean and standard deviation for TpR in the three time intervals were: TpRI=1.08+/-0.18, TpRII=0.94+/-0.09 and TpRIII=0.96+/-0.20. TpR values were not significantly different from those in the control group (TCGp=1.00+/-0.05). However, TpRI was significantly higher than TpRII (P=0.043). The mean and standard deviation for TdR in the three time intervals were: TdRI=1.10+/-0.41, TdRII=1.05+/-0.15 and TdRIII=1.13+/-0.36. TdR values were not significantly higher than in the control group (TCGd=1.00+/-0.04) (P=0.777). These results support the concept that three-phase bone imaging is able to quantify and determine that activation occurs in the distal femoral and proximal tibial growth plates of fractured femora. This phenomenon may explain the overgrowth observed in this injured bone structure.

Mortality attributed to myocardial infarction in the male and female population of Salvador, BA, between 1981 and 1996.

OBJECTIVE: To describe according to gender the trend in mortality attributed to myocardial infarction (MI) in the population of Salvador, Bahia between 1981 and 1996. METHODS: This study was on mortality due to MI estimates by period and gender of the city of Salvador, Bahia. Data from 1981 to 1996 were stratified by quadrienia, and the percentage reduction in death rate due to MI relative to the preceding period (PRR) was determined. Comparisons between genders were expressed by the male/female death ratio (DR) based on the gender-related PPR. RESULTS: An overall increase of approximately 8% was observed in the death rate attributed to MI for the period 1985-1988 (89.2/10 5 individuals / year) versus the period 1981-1984 (82.1/10(5)/ year). In the subsequent periods, overall reductions of 10% and 20.3% were observed for the periods 1989-1992 and 1993-1996, respectively. For men, the PPRs were 11.1 in the period 1989-1992 and 22.7% in the period 1993-1996. The PPRs in women were lower: 8.6% and 17.4% between 1989 and 1992, and 1993 and 1996, respectively. Death rate reduction was greater for men than women, then the male/female DR decreased from 1.66 in 1981-1984 to 1.35 in 1993-1996. CONCLUSION: The results indicate a trend towards a reduction in the death rate attributed to myocardial infarction in the city of Salvador from the second half of the 1980s onwards, striking in men.

Thyroid disease in HCV carriers undergoing antiviral therapy with interferon plus ribavirin.

High prevalence of thyroid autoantibodies, with or without overt thyroiditis, has been described in hepatitis C patients, particularly in those undergoing alpha-interferon treatment. The aim of this study was to describe the frequency and clinical outcome of thyroid disease in a cohort of HCV carriers before and during combination therapy with interferon plus ribavirin. Between May, 1997, and May, 1999, 111 previously untreated (naive) patients were treated with a-interferon plus ribavirin for 6 or 12 months. Of those, 67 (60%) patients were male and 44 (40%) female. Thyroid function was evaluated in all patients by testing free T4, TSH and antiTPO within 30 days prior to treatment, 90 days after treatment was initiated, and 6 months after treatment was concluded. Abnormal thyroid tests were observed in 4 (3.6%) patients--1 male and 3 female--before the onset of antiviral treatment. Three patients were already undergoing T4 replacement due to Hashimoto thyroiditis and 1 patient had positive antiTPO with normal free T4 and TSH. All 4 patients completed the treatment regime for HCV, but required hormone replacement. Among the patients with a normal thyroid function test prior to treatment (107 cases), 5 (4.6%) developed thyroid test abnormalities; 2 patients had hypothyroidism due to autoimmune thyroiditis; 1 patient became positive for antiTPO antibodies but thyroid function remained normal, and 2 patients had subacute thyroiditis. Four of these patients (80%) were female and 1 was male (20%). A family history of thyroid disease was strongly predictive of thyroid abnormalities during antiviral treatment. In conclusion, there is a low prevalence of thyroid function abnormalities in HCV carriers with no prior antiviral treatment. Family history of thyroid disease reinforces the special attention to thyroid abnormality development before considering antiviral therapy. Subacute thyroiditis during combination therapy was observed, but its pathogenesis is still unknown. Evaluation of thyroid function during and after antiviral treatment is strongly recommended because thyroid related symptoms can be easily misinterpreted as medication side effects.