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Biomedical subjects

A Trilla

Publications and source records attributed to A Trilla.

At least 19 recordsLinked to original sources
PubMed2001

The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals.

OBJECTIVE: Withdrawal of a drug from the market for safety reasons is a serious and sometimes complex decision. The scientific evidence supporting drug withdrawals in the past years is critically appraised. METHODS: With data provided by the Spanish Medicines Agency, all drugs withdrawn from the Spanish market for safety reasons from January 1990 to December 1999 were identified. The adverse drug reactions (ADRs) were classified by the year of withdrawal, by the organ/system affected and by the alleged type of reaction (Rawlins and Thompson classification). A systematic review of the literature was performed. RESULTS: A total of 22 drugs were withdrawn from the market due to safety reasons. In 18 of 22 cases (82%), the evidence supporting the drug withdrawal came from individual case reports, cases series or the combination of data provided by randomised clinical trials and case reports. Hepatic (eight cases) and cardiac (five cases) reactions accounted for 59% (13 of 22) of the total withdrawals. In 10 of 22 (45%) cases, drug withdrawal was clearly due to type-B reactions. Only four withdrawals were based on evidence from observational studies including a comparison group. CONCLUSION: Case reports are the main source of information used to withdraw a drug from the market for safety reasons. It is necessary to improve the quality of evidence supporting the withdrawal process of drugs linked to unexpected and severe ADRs. The use of large databases to perform cohort or nested case-control analyses is the most efficient and reliable method to study type-A class effect ADRs. The implementation of such databases in different countries could increase the quality of the information on ADRs by allowing researchers to conduct efficiently these type of studies.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Review of the utilisation of a university hospital in Barcelona (Spain): evolution 1992-1996.

BACKGROUND: To test the applicability of the appropriateness evaluation protocol (AEP) as a tool for reviewing hospital utilisation. To quantify and to compare the rate of inappropriate admissions and amount of in-hospital days, emphasising the main causes and factors in the hospital associated with inappropriateness during the studied periods of time. PATIENTS AND METHODS: Two retrospective studies were carried out, the first one in 1992, when 2048 clinical histories were analysed, and the second in 1996, with 1099 reviewed histories. The tool used for the evaluation of the level of hospital utilisation is the AEP. RESULTS: The proportion of admissions considered to be inappropriate was 25% (95% CI: 20.8-24.5) in 1992, and 16% (95% CI: 13.8-18.2) in 1996. Premature admission was the most frequent cause of inappropriateness in both periods. The logistic regression model built for the dependent variable admission showed the following variables to be associated to inappropriateness: scheduled admission (OR: 15; 95% CI: 10.8-20.7) and (OR: 10; 95% CI: 6-16.5), weekend admission (OR: 2; 95% CI: 1.3-1.2) and (OR: 2; 95% CI: 1.2-2.3), for 1992 and 1996, respectively. The rate of inappropriate in-hospital stays in 1992 was 29% (95% CI: 28.3-29.6), and 13.5% (95% CI: 12.7-14.3) in 1996. Hospital organisational problems were the main cause of inappropriate in-hospital days in 1992, and diagnostic/ therapeutical tests that could be performed ambulatorily ranked first in 1996. The logistic regression model built for the dependent variable in-hospital days had the following independent variables associated to its inappropriateness: discharge on weekdays (OR: 1.4; 95% CI: 1.2-1.8) and (OR: 0.6; 95% CI: 0.5-0.8) and length of stay (OR: 2; 95% CI: 1.8-2.4) and (OR: 2.4; 95% CI: 2.3-2.5), for 1992 and 1996 respectively, among other variables. CONCLUSION: Periodic checking of the utilisation levels with the application of methods such as the AEP will contribute towards adapting hospital management in the more competitive current setting.

Female↗
PubMed2000

[Comparative analysis of articles published by Spanish authors (1993-1997) in biomedical journals with high impact factor].

BACKGROUND: To identify the Spanish scientific production amongst different areas of clinical knowledge, and to compare it with those of five other European Union countries. METHOD: Review of MEDLINE data base, for the period 1993-1997. Search limited to four journals, selected, for 10 different medical specialties (Cardiology, Endocrinology, Infectious Diseases, Gastroenterology-Hepatology, Haematology, Nephrology, Pneumology, Neurology, Oncology, Rheumatology). Articles published by authors from Germany, France, Italy, The Netherlands, Sweden and Spain. Journals included in the Internal Medicine subject classification were independently analysed. Data were also related with several econometric indexes. RESULTS: A total of 1,763 original articles published by Spanish authors were identified in the journal's sample over the analysed period (2.08 articles per 100 all published articles). Spain contributes to the total achieved by the six European countries analysed with 9.07 articles per 100 published articles. Gastroenterology-Hepatology was the medical specially which has more articles published by Spanish authors (total: 338 articles; 4.15 articles/100 published articles); and Oncology the one with less articles published (1.26 articles/100 published articles). The mean IF value per journal by article is highest for Gastroenterology-Hepatology (4.86 FI/article) and lowest for Pneumology (2.42 FI/article). Spain is the last amongst all six European countries analyzed in Endocrinology, Oncology and Haematology, and second to last in all others except for Gastroenterology-Hepatology (4th place). Mean cost for each article produced by Spanish authors in the analyzed sample was 0.49 US $ according the health expenditures per capita, and 0.07 US $ according the R+D expenditures per capita. Data from the independent analysis of Internal Medicine journals also showed that Gastroenterology and Hepatology is the subspecialty with a higher number of papers published in those journals. CONCLUSIONS: All efforts devoted to improve the quality of Spanish biomedical research, specially in clinical research, had produced positive, but uneven, results, measured by the number and impact factor of original articles published in top ranked biomedical journals. The overall distribution of high impact factor scientific production by specialties is poor when compared to the European Union countries included in the analysis. Those results showed several improvement opportunities. Besides increasing the overall budget for R+D, its is likely that the time has come for backing the highest quality Spanish biomedical research, the one that offers greater and better chances for achieving scientifically valid results, and is published in high impact factor biomedical journals.

Bibliometrics↗
PubMed2000

[Nosocomial infections due to opportunistic fungi: analysis of a news outbreak in the Spanish press].

BACKGROUND: To study an outbreak of media news related to nosocomial infections due to opportunistic fungi in Spanish hospitals. METHOD CASE DEFINITION: any news related to possible nosocomial infection due to opportunistic fungi in Spanish hospitals, published in national or local daily newspapers, over the pre-epidemic (July-December, 1998) and epidemic periods (January-June, 1999). All news were reviewed and identified using global press reports summaries, prepared by two independent sources, and were analyzed by three different observers. RESULTS: Over the pre-epidemic period there were not any news related to nosocomial infections due to opportunistic fungi. Over the epidemic period, a total of 218 news were identified, 154 (71%) published in national newspapers and 64 (29%) in local ones. We analyzed separately 18 editorials or opinion articles related to this subject. The epidemic curve (distribution of news by week) showed an incidence news peak at week 5 (102 news, 46.7% of all news published). The media mentioned up to 19 different hospitals as institutions with possible cases of nosocomial fungal infections. After week 8, news incidence drop, and remain thereafter at minimum levels. CONCLUSIONS: The example provided by the analysis of this outbreak of media news, related to nosocomial infections by Aspergillus an other opportunistic fungi, is useful to allow us understand how some medical news arise, develop and were transmitted. The public alert situation created in Spain was remarkable, and it is likely that there was a transient loss of confidence in the safety of public health institutions. Today's medicine requires a great and better openness to the media, and a better cooperation between both parts.

Cross Infection↗
PubMed2000

Clinical evaluation of an in-house IS6110 polymerase chain reaction for diagnosis of tuberculosis.

The aim of this study was to clinically validate a heminested polymerase chain reaction (PCR) method, based on the IS6110 insertion segment of Mycobacterium tuberculosis complex, for the diagnosis of tuberculosis. Samples of pulmonary, extrapulmonary and blood origin were collected prospectively from 331 patients. All samples were processed to detect acid-fast bacilli by direct stain, culture and PCR. The gold standard comparison was a clinically based final case definition of tuberculosis corresponding to group 3 of the American Thoracic Society's classification system. The sensitivities of stain, culture and PCR were 41%, 65% and 59%, respectively. Overall specificity exceeded 97% for all techniques. The combination of PCR and direct stain achieved a sensitivity similar to that of culture alone. The PCR method detected 74 of 95 (78%) culture-positive results. In a hospital setting, PCR could be a useful, reliable tool for diagnosis of tuberculosis and may be introduced as a complementary routine diagnostic laboratory method.

Culture Media↗
PubMed2000

Perceived quality of care in pregnancy assessment before and after delivery.

OBJECTIVE: To assess the perceived quality of care in a group of pregnant women attended in a public Hospital. STUDY DESIGN: All pregnant women seen at the Hospital Clinic of Barcelona in 1996. Two study groups were defined: group A, women seen at the outpatient clinic as a regular follow-up visit for pregnancy, and group B, women seen at the outpatient clinic for follow-up after delivery. A satisfaction questionnaire survey was used in a random sample of both groups of women. RESULTS: Total number of interviews performed was 174. Both groups, A and B were comparable. Scores recorded in both groups were significantly different (P<0.01) for the clinical follow-up and privacy variables (regarded as better than expected). The difference in scores for the information supplied was also statistically significant (P<0.01), but regarded as worst than expected. CONCLUSIONS: The analysis of satisfaction does not seem to follow a linear, straightforward explanation. The differences seen strongly suggest the need of patient's satisfaction surveys to be specific by dimension and tailored to patients' expectations.

Adult↗
PubMed2000

[Vancomycin and teicoplanin use as antibiotic prophylaxis in cardiac surgery: pharmacoeconomic study].

BACKGROUND: To assess the economical impact of vancomycin use versus teicoplanin use as antibiotic prophylaxis for patients undergoing cardiac surgery for valve replacement (VR) and coronary artery by-pass (CABS) procedures. PATIENTS AND METHODS: This is an ancillary cost minimization analysis of a double blinded, parallel groups, randomised clinical trial (RCT), with the main objective of comparing the safety and efficacy of these antibiotics. 500 patients were included in the study; 267 in the CABS group and 233 in the VR group. The CABS patients received 1 g vancomicin or 400 mg teicoplanin, plus 150 mg netilmicin. The VR group received a second dose of each drug after extracorporeal circulation. In order to calculate the costs we considered the direct cost of the drug, the i.v. mix and the administration costs, together with personnel and structure costs. We considered two different situations: the administration of drugs within the surgical room theatre and in the medical ward. RESULTS: The demographic data of both groups were comparable. The frequency of severe adverse drug reactions (ADR) were similar (0.4%) in both groups, as well as the post-operative infection rates (8.6%). Differences were seen in the frequencies of low severity ADRs: 20.4% in the vancomycin group and 1.6% in the teicoplanin group. When the antibiotics were administered in the surgical room, among CABS patients the costs were 8,265 pts. for the teicoplanin group and 12,005 pts. for the vancomycin group; while among VR patients, costs were respectively 11,661 pts. and 14,528 pts. Administration costs of teicoplanin and vancomycin within a medical ward setting, however, the costs were 6,740 pts. and 2,809 pts. for CABS patients, and 5,308 pts. and 10,140 pts. for VR patients, respectively. CONCLUSIONS: The costs of antibiotic prophylaxis among cardiac surgery patients heavily depends on the setting and circumstances of drug administration. The minimization cost analysis indicates that teicoplanin is the most cost-effective option if the drug is administered within the surgical area, while vancomycin is the less costly option when administered within the medical ward. However, if the second option is to be chosen, it is necessary to assure the right plasmatic drug levels of the antibiotic at the beginning of the surgical procedure.

Aged↗
PubMed2000

[Analysis of the cost-effectiveness relationship in the empirical treatment in patients with infections of the lower respiratory tract acquired in the community].

BACKGROUND: Cost of treatment of community-acquired infections in Spain is an important factor in overall health expenditures. The aim of this study was to assess the direct health costs related with the treatment of patients with community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECB) due to infection, using different antibiotic options, and to identify main cost drivers. METHODS: A basic decision analysis model was developed, including probabilities estimation derived from the literature review, supplemented when needed by the opinion of a panel of 8 Spanish physicians (Delphi technique). Four groups of antibiotics were included (macrolides, beta-lactam, fluoroquinolones and cephalosporins) in two different groups: patients with CAP without hospital admission criteria and patients with AECB due to respiratory infection. The analytic horizon and the perspective used were those of the Spanish National Health Service. Direct cost were assessed (drugs, outpatient visits, hospital admissions, diagnostic tests). Indirect cost were not included in the model. Final costs uses as main outcome measure the average cost per patient treated. All results were calculated following a fold-back technique. Sensitivity analysis were included allowing for variations in several clinically relevant parameters. RESULTS: 1. Patients with CAP: Hospital admissions, directly related to the effectiveness rate of initial empirical antibiotic therapy, were the main cost driver (50%-70%). Acquisition costs of initial antibiotic therapy only account for 2%-13% of total costs. 2. Patients with AECB: Outpatient visits are the main cost driver for these group of patients (49% of total costs). Hospital admission costs are also an important cost driver (40%-51% of total costs). Acquisition costs of initial antibiotic therapy account for 4%-28% of total costs. Clinical effectiveness of first antibiotic option is the main variable regarding the cost-effectiveness rate. CONCLUSION: The model here presented showed that acquisition costs of first empirical antibiotic therapy are only a small proportion of total costs related with the management of community acquired lower respiratory tract infections in Spain. The clinical effectiveness rate of the first antibiotic used is the main variable which determines the final average cost per patient cured. For patients with lower respiratory tract infections the therapeutic option with a better cost-effectiveness ratio must be chosen, in order to minimize the risk of therapeutic failure after first line therapy, and should not be selected only by its lower acquisition costs.

Anti-Bacterial Agents↗
PubMed1999

[Excess length of stay attributable to nosocomial bacteremia: usefulness of the Hospitalization Appropriateness Protocol].

BACKGROUND: To evaluate the usefulness of the Appropriateness Evaluation Protocol (AEP) for assessing the extra length of stay attributable to nosocomial bacteremia. PATIENTS AND METHODS: Retrospective review of the medical records (1989, 1990 and 1991) of all patients, who developed Staphylococcus aureus nosocomial bacteremia. Evaluation of hospital stay was performed using the AEP. Calculation of the kappa index and intraclass correlation coefficient. RESULTS: A total of 158 patients were included S. aureus nosocomial bacteremia is responsible for a mean excess length of stay of 4.3 days per patient. Kappa index for the method used was 76%, and intraclass correlation coefficient was 61%. CONCLUSIONS: The AEP has been shown to be a reliable tool for assessing the extra days of stay attributable to nosocomial bacteremia in the Spanish National Health System. The use of AEP should be extended to assess the extra stay attributable to other types of nosocomial infections.

Adult↗
PubMed1999

Handwashing with soap or alcoholic solutions? A randomized clinical trial of its effectiveness.

BACKGROUND: The effectiveness of an alcoholic solution compared with the standard hygienic handwashing procedure during regular work in clinical wards and intensive care units of a large public university hospital in Barcelona was assessed. METHODS: A prospective, randomized clinical trial with crossover design, paired data, and blind evaluation was done. Eligible health care workers (HCWs) included permanent and temporary HCWs of wards and intensive care units. From each category, a random sample of persons was selected. HCWs were randomly assigned to regular handwashing (liquid soap and water) or handwashing with the alcoholic solution by using a crossover design. The number of colony-forming units on agar plates from hands printing in 3 different samples was counted. RESULTS: A total of 47 HCWs were included. The average reduction in the number of colony-forming units from samples before handwashing to samples after handwashing was 49.6% for soap and water and 88.2% for the alcoholic solution. When both methods were compared, the average number of colony-forming units recovered after the procedure showed a statistically significant difference in favor of the alcoholic solution (P <.001). The alcoholic solution was well tolerated by HCWs. Overall acceptance rate was classified as "good" by 72% of HCWs after 2 weeks use. Of all HCWs included, 9.3% stated that the use of the alcoholic solution worsened minor pre-existing skin conditions. CONCLUSIONS: Although the regular use of hygienic soap and water handwashing procedures is the gold standard, the use of alcoholic solutions is effective and safe and deserves more attention, especially in situations in which the handwashing compliance rate is hampered by architectural problems (lack of sinks) or nursing work overload.

1-Propanol↗
PubMed1999

Perioperative antibiotic prophylaxis in Spanish hospitals: results of a questionnaire survey. Hospital Pharmacy Antimicrobial Prophylaxis Study Group.

A questionnaire survey was sent to a random sample of the Spanish network of National Health System public acute-care hospitals. Of responding institutions (representing 25% of Spanish hospital beds), nearly 75% had active surveillance programs for the prevention and control of surgical-site infections (SSIs), but only 20% performed postdischarge surveillance. Overall, perioperative antibiotic prophylaxis (PAP) was used in 84% of all surgical procedures. For 77% of procedures, there were written guidelines for the choice and use of PAP. Cefazolin was the most commonly used antibiotic (38%). Duration of PAP was shorter than 24 hours in 75% of procedures, and only a single dose was given in 52% of procedures. PAP was commonly used in breast (52%) and inguinal hernia repair (69%) procedures, as well as in laparoscopic abdominal surgery (86%). In summary, the use of PAP in Spanish hospitals is adequate, but improvements can be made in the frequency of prolonged PAP and in the use of broad-spectrum antibiotics. Surveillance systems for SSI, including postdischarge follow-up, also should be improved.

Antibiotic Prophylaxis↗
PubMed1999

[Use of diagnostic tests in the context of evidence-based medicine].

BACKGROUND: The advances of medicine over the last twenty years include the use of new tests and diagnostic methods in clinical practice. At the same time, we have witnessed the introduction of a strong movement, named Evidence Based Medicine, which basically includes a serious attempt for rationalizing the findings of more than 50 years of biomedical research, and to apply them properly to our patients as well as to the whole population. METHODS: Review of the published literature. All the recommendations are used in a practical example. RESULTS: Summary of the current existing recommendations for the assessment of a new diagnostic tool before its clinical application, and discussion of possible solutions for achieving a more efficient use of these tests. CONCLUSIONS: There are enough evidences for defining criteria for a uniform evaluation process of new diagnostic tests. The criteria could be useful for the clinical application of these tests.

Bias↗
PubMed1998

[Impact of sabbatical leave on hospital and university promotions].

BACKGROUND: The aim of this study was the assessment of the scientific production and impact on academic and/or hospital promotion ob sabbatical leaves of medical staff from a University hospital. POPULATION AND METHODS: A matched case-control design was used. The Mantel-Haenszel odds ratio (ORMH) and its 95% confidence intervals were calculated. A total of 52 sabbaticals leaves were analyzed with successful matching for 43 pairs. RESULTS AND CONCLUSIONS: Taking a sabbatical leaves is associated with a significant higher chance of hospital promotion (ORMH = 7.5; CI 95%, 1.71-32.78; o = 0.004), but there is not a significantly higher chance of academic promotion (ORMH = 0.66; CI del 95%, 0.23-1.83; p = 0.60).

Career Mobility↗