Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study.

BACKGROUND: There is scarce scientific information assessing participants' perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. METHODS: To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. RESULTS: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants' health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. CONCLUSION: Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions.

Use of antibiotics in upper respiratory infections on patients under 16 years old in private ambulatory medicine.

OBJECTIVE: To assess antibiotic use for upper respiratory infections (URI) treatment on patients under 16 years-old who are beneficiaries of a pre-paid health care scheme. MATERIAL AND METHODS: A database containing the record of all the medical prescriptions for URI treatment, from May 1997 to April 1998 was analyzed. Patients were under 16 years old and had been diagnosed with common colds, pharyngitis, bronchitis, sinusitis, otitis, and other unspecified upper respiratory tract infections. Three hundred and fifty-one physicians of seven different specialties who attended 25,300 beneficiaries wrote such prescriptions. RESULTS: A total of 30,889 assorted medications were prescribed to 5,533 patients with the above diagnoses. Antibiotics were prescribed for 77.5% of all diagnoses, ranging from 58% for pharyngitis to 91% for laryngitis. The most frequently used antibiotics were: penicillin, cephalosporins, and macrolides. CONCLUSIONS: This study presents the information of antibiotics prescription practices for URI in a pre-paid health plan in Mexico. These findings may be used to support specific campaigns for rational use of antibiotics among children attended at private ambulatory health care practices.

Use of antibiotics in upper respiratory infections on patients under 16 years old in private ambulatory medicine

OBJECTIVE: To assess antibiotic use for upper respiratory infections (URI) treatment on patients under 16 years-old who are beneficiaries of a pre-paid health care scheme. MATERIAL AND METHODS: A database containing the record of all the medical prescriptions for URI treatment, from May 1997 to April 1998 was analyzed. Patients were under 16 years old and had been diagnosed with common colds, pharyngitis, bronchitis, sinusitis, otitis, and other unspecified upper respiratory tract infections. Three hundred and fifty-one physicians of seven different specialties who attended 25 300 beneficiaries wrote such prescriptions. RESULTS: A total of 30 889 assorted medications were prescribed to 5 533 patients with the above diagnoses. Antibiotics were prescribed for 77.5 percent of all diagnoses, ranging from 58 percent for pharyngitis to 91 percent for laryngitis. The most frequently used antibiotics were: penicillin, cephalosporins, and macrolides. CONCLUSIONS: This study presents the information of antibiotics prescription practices for URI in a pre-paid health plan in Mexico. These findings may be used to support specific campaigns for rational use of antibiotics among children attended at private ambulatory health care practices

[Risk of drug interactions. Combinations of drugs associated with ventricular arrhythmias]. / Riesgo de interacciones medicamentosas. Combinaciones de medicamentos asociados a arritmia ventricular.

OBJECTIVE: To determine the frequency of concurrent use of cisapride, astemizole and terfenadine with macrolides and azole antimitotics, drug combinations that have been reported in the literature as producing a pharmacological interaction associated with potentially fatal ventricular arrhythmias. MATERIAL AND METHODS: A retrospective analysis of a total of 72,444 prescriptions generated by 611 physicians during a 6 months period for ambulatory patients, was performed. The database included a register of automatic alerts produced every time a predetermined drug combination was detected. RESULTS: 145 potentially risk situations were detected, with an incidence rate to 2.1 cases per 1,000 prescriptions, which increases to 6.2% when prescriptions for terfenadine, astemizole, and cisapride were included, with 12, 9 y 5%, respectively. Only 36 physicians (6%) wrote prescriptions producing alerts, and about half (45%) were pediatricians. The same physician prescribed both drugs in 31% of the cases. CONCLUSION: The use of drug combinations associated with a high risk of potentially fatal ventricular arrhythmias is relatively high in Mexico. An electronic online detecting system showed to be useful in preventing this kind of potential pharmacological interactions.

Riesgo de interacciones medicamentosas. Combinaciones de medicamentos asociados a arritmia ventricular / Risk of drug interactions. Combinations of drugs associated with ventricular arrhythmias

OBJECTIVE: To determine the frequency of concurrent use of cisapride, astemizole and terfenadine with macrolides and azole antimitotics, drug combinations that have been reported in the literature as producing a pharmacological interaction associated with potentially fatal ventricular arrhythmias. MATERIAL AND METHODS: A retrospective analysis of a total of 72,444 prescriptions generated by 611 physicians during a 6 months period for ambulatory patients, was performed. The database included a register of automatic alerts produced every time a predetermined drug combination was detected. RESULTS: 145 potentially risk situations were detected, with an incidence rate to 2.1 cases per 1,000 prescriptions, which increases to 6.2 when prescriptions for terfenadine, astemizole, and cisapride were included, with 12, 9 y 5, respectively. Only 36 physicians (6) wrote prescriptions producing alerts, and about half (45) were pediatricians. The same physician prescribed both drugs in 31 of the cases. CONCLUSION: The use of drug combinations associated with a high risk of potentially fatal ventricular arrhythmias is relatively high in Mexico. An electronic online detecting system showed to be useful in preventing this kind of potential pharmacological interactions.

Tabaquismo involuntario y sintomatología respiratoria: un comentario clínico / Involuntary smoking and respiratory symptomatology: a clinical comment

Con objeto de determinar si existe asociación entre tabaquismo pasivo o "involuntario" y sintomatología respiratoria se efectuó un estudio piloto que incluyera casos y controles no igualados. Se examinaron 146 pacientes con problemas respiratorios atendidos en la consulta externa de la Unidad de Neumología y 40 sujetos control recabando información de tabaquismo activo y pasivo, cuyos resultados se analizaron con la prueba de comparación de proporción de la distribución Z y riesgo relativo (RR), para comparar fumadores activos (FA) y pasivos (FP) y sujetos libres del humo del tabaco (NFP). Se encontró diferencia estadísticamente significativa entre FP y NFP, Z=2.80 (p<0.01). El RR fue de 3.414 (p< 0.008) en los FP con respecto a los NFP. No hubo diferencia entre FA y FP

Tuberculosis pulmonar: problema hospitalario vigente / Pulmonary tuberculosis. A still present problem in the hospital setting

Antecedentes: A pesar de que el tratamiento actual para la tuberculosis (TB) ha probado ser eficaz en más del 99 por ciento de los casos, este padecimiento continúa siendo una de las principales causas de hospitalización en el Hospital General de México, SSA(HGMS). De 1981 a 1990 la TB fue responsable de 26.4 por ciento del total de casos hospitalizados en el servicio de neumología. Diseño: Comparación de dos series de casos. Pacientes: Doscientos cincuenta casos con diagnóstico confirmado de TB, 150 de 1975 y 100 de 1990. Análisis: Se comparan algunas variables clínico-quirúrgicas utilizando chi cuadrada para grupos independientes. Resultados: La frecuencia de TB manejada intrahospitalariamente es muy similar en ambas series. Los pacientes con TB que se hospitalizaban en 1975 tenían mayor mortalidad, mayor frecuencia de casos quirúrgicos y de presentaciones avanzadas o cavitadas. No se encontró mucha diferencia en cuanto a las indicaciones para manejo hospitalario. Conclusiones: Se demuestra que la TB continúa siendo un problema en el HGMS. Las Formas graves de la TB han disminuido considerablemente. Actualmente, un paciente tuberculoso debe hospitalizarse exclusivamente si existe alguno de los siguientes factores: (i) Hemoptisis, (ii) Enfermedad asociada descompensada, (iii) Insuficiencia cardiorrespiratoria y (iv) Deterioro general severo. Los casos con SIDA pueden requerir hospitalización en casos con TB diseminada o grave

Cáncer broncogénico en pacientes no fumadores / Bronchogenic carcinoma in nonsmoker patients

Objetivo: Explorar diferencias clínico-epidemiológicas entre pacientes portadoras de cáncer broncogénico (CBr) fumadores y no fumadores. Diseño: Revisión comparativa de casos. Población y Métodos: Se revisaron expedientes de 288 pacientes con diagnóstico confirmado de CBr hospitalizados en la Unidad de Neumología del HGM de 1983 a 1989. Se formaron dos grupos: (i) fumadores (n=196, 68 por ciento del total) y (ii) no fumadores (n=92, 32 por ciento del total). Se identificaron y compararon variables suficientemente cubiertas en los expedientes. Resultados: Se encontró diferencia significativa entre fumadores y no fumadores en: (i) sexo (17.8 por ciento hombres vs. 73 por ciento de mujeres, respectivamente); (ii) ocupaciónm (delicados al hogar en 14 por ciento vs. 68 por ciento); (iii) lugar de orígen (procedencia urbana en 58 por ciento vs. 73 por ciento); (iv) Frecuencia de estirpe adenocarcinoma (28 por ciento vs. 54 por ciento);(v) Frecuencia de derrame pleural (37 por ciento vs 57 por ciento) y (vi) Metástasis a SNC (1 por ciento vs. por ciento). No hubo diferencia entre los grupos en cuento a edad, estado civil, tiempo de evolución, aspecto endoscópico, aspecto radiológico ni metástasis en general. Conclusiones: Los resultados son consistentes con la literatura en cuanto a la mayor frecuencia de sexo femenino y estirpe adenocarcinoma en el grupo de no fumadores. Merece ser considerada la mayor frecuencia de procedencia urbana en nuestra serie. Los hallazgos han servido de base para estudios prospectivos actualmente en proceso

Análisis metodológico de resúmenes de los trabajos de investigación de los alumnos de los cursos de maestría y doctorado de la Faculdad de Medicina / Metodological analysis of the summaries of the research work performed by the gradduate studentes of the School f Medicine CUNAW Presented at their annual meeting

Objetivo del estudio: Describir la frecuencia con que se identifican, en los resúmenes de investigación, los estándares metodológicos considerados como fundamentales y necesarios para obtener una conclusión válida. diseño del estudio: Encuesta descriptiva. Patrón de referencia: Resúmenes de los trabajos de investigación presentados en la reunión de alumnos de Maestría y Doctorado de la Facultad de Medicina de la Universidad Nacional Autónoma de México. Unidad de estudio: Se revisó una muestra sistemática de 326 resúmenes correspondientes a los años de 1984 a 1986. Resultados Principales: La mayor parete de los resúmenes presentaron fallas metodológicas en relación a los puntos analizados. Entre éstos se cuentan: Una insuficiente referencia a los objetivos, diseño de la investigación, patrón de referencia, descripción de las unidades de estudio y definición de las mediciones. Las investigaciones relacionadas al área de Epidemiología Clínica presentaron defectos considerados como graves en al estructura del estudio. Se identificaron además, deficiencias en la descripción de los métodos estatísticos utilizados. Conclusiones: Dada la insuficiente información metodológica proporcionada por los investigadores en un resumen en las reuniones analizadas, elector se encuentra incapacitado para llevar a cabo un juicio sobre los méritos de un estudio. Se propone utilizar un formato estructurado que permita la revisión sistemática de dichos critérios