[Validity of tests for initial diagnosis and its concordance with final diagnosis in patients with suspected benign prostatic hyperplasia]. / Validez de las pruebas utilizadas en el diagnóstico inicial y su concordancia con el diagnóstico final en pacientes con sospecha de hiperplasia benigna de próstata.

OBJECTIVE: To assess the validity of diagnostic tools available at the primary care setting [medical history (MH), I-PSS questionnaire, digital rectal examination (DRE) and prostate specific antigen (PSA) evaluation] for the diagnosis of benign prostatic hyperplasia (BPH). SUBJECTS AND METHODS: 363 patients with suspected prostatic disease referred to urology outpatient clinics were included. For every subject initial BPH diagnosis was collected at each of the following sequential procedures: 1) MH; 2) I-PSS; 3) DRE; and 4) PSA. Each of these diagnostic decisions were compared to a final diagnosis (gold standard) reached after the addition of urinary sediment analysis, ultrasonographic assessment of residual volume and prostatic volume, and peak urinary flow measurement. A descriptive analysis was undertaken: validity and concordance between each diagnostic step and the gold standard was calculated. RESULTS: Sensitivity, specificity, positive predictive value, and negative predictive value of diagnosis based on MH+I-PSS+DRE+PSA with respect to the gold standard were 91%, 65%, 95% and 50%, respectively. The percentage of agreement and kappa index between both diagnostic strategies were 87.9% and 0.5, respectively. CONCLUSIONS: Concordance between BPH initial diagnosis based on MH+I-PSS+DRE+PSA and diagnosis based on a full range of tests was high, thus allowing recommending the use of this group of initial diagnostic procedures, which are available to the primary care physician, not only as a first diagnostic step in patients with suspected BPH, but also as a valid strategy to prevent unnecessary delay in its initial management and to facilitate appropriate referral from primary to specialized care.

Validez de las pruebas utilizadas en el diagnóstico inicial y su concordancia con el diagnóstico final en pacientes con sospecha de hiperplasia benigna de próstata / Validity of tests for initial diagnosis and its concordance with final diagnosis in patients with suspected benign prostatic hyperplasia

Objetivo: Determinar la validez de los métodos diagnósticos al alcance del primer escalón del nivel asistencial [historia clínica (HC), cuestionario I-PSS, tacto rectal (TR) y determinación del antígeno prostático específico (PSA)], para el diagnóstico de la hiperplasia benigna de próstata (HBP). Población y Métodos: Participaron 363 pacientes atendidos en consultas externas de urología por sospecha de HBP. El diagnóstico inicial de HBP se fue realizando tras la aplicación secuencial de cada una de las siguientes pruebas: 1) HC 2) I-PSS 3) TR y 4) PSA. El diagnóstico emitido tras cada uno de los 4 pasos, se contrastó con el diagnóstico final (gold standard) tras la evaluación de sedimento urinario, volumen miccional residual y tamaño prostático por ecografía y flujometría urinaria. Se realizó un análisis descriptivo y se calculó la validez y concordancia entre cada paso diagnóstico y el gold standard. Resultados: La sensibilidad, especificidad, valor predictivo positivo y valor predictivo negativo del diagnóstico basado en HC+IPSS+ TR+PSA con respecto al diagnóstico final fueron 91%, 65%, 95% y 50% respectivamente. El porcentaje de acuerdo y el índice kappa entre ambos diagnósticos fueron 87,9% y 0,5, respectivamente. Conclusiones: La concordancia entre el diagnóstico inicial basada en la historia clínica, cuestionario I-PSS, TR y PSA, y el diagnóstico final de HBP es alta, lo que permite recomendar el uso del conjunto de estas pruebas accesibles en el primero de los escalones asistenciales no sólo como primer paso diagnóstico en los pacientes con sospecha de HBP, sino también como estrategia válida para evitar retrasos innecesarios en su manejo inicial y facilitar la adecuada derivación entre los niveles de atención primaria y especializada

Objective: To assess the validity of diagnostic tools available at the primary care setting [medical history (MH), I-PSS questionnaire, digital rectal examination (DRE) and prostate specific antigen (PSA) evaluation] for the diagnosis of benign prostatic hyperplasia (BPH). Subjects and Methods: 363 patients with suspected prostatic disease referred to urology outpatient clinics were included. For every subject initial BPH diagnosis was collected at each of the following sequential procedures: 1) MH; 2) I-PSS; 3) DRE; and 4) PSA. Each of these diagnostic decisions were compared to a final diagnosis (gold standard) reached after the addition of urinary sediment analysis, ultrasonographic assessment of residual volume and prostatic volume, and peak urinary flow measurement. A descriptive analysis was undertaken; validity and concordance between each diagnostic step and the gold standard was calculated. Results: Sensitivity, specificity, positive predictive value, and negative predictive value of diagnosis based on MH+IPSS+ DRE+PSA with respect to the gold standard were 91%, 65%, 95% and 50%, respectively. The percentage of agreement and kappa index between both diagnostic strategies were 87.9% and 0.5, respectively. Conclusions: Concordance between BPH initial diagnosis based on MH+I-PSS+DRE+PSA and diagnosis based on a full range of tests was high, thus allowing recommending the use of this group of initial diagnostic procedures, which are available to the primary care physician, not only as a first diagnostic step in patients with suspected BPH, but also as a valid strategy to prevent unnecessary delay in its initial management and to facilitate appropriate referral from primary to specialized care

[Socioclinical and diagnostic characteristics of prostatism in Spain at the end of the 20th century]. / Características sociosanitarias y diagnósticas del paciente prostático en España a finales del siglo XX.

RATIONALE: To study sociodemographic characteristics and current diagnostic and therapeutic behaviour with Benign Prostate Hyperplasia (BPH) patients in Spain at the end of the 20th century. METHODS: Sociodemographic, clinical, therapeutic and quality of life (QoL) data from study ESECI-98, conducted in Spain (1998-1999) in patients with BPH. RESULTS: Nine hundred and forty nine patients were evaluable, with a mean (+/- SD) age of 65.6 (+/- 7.8) years, with concomitant diseases (40%), pain/discomfort (34%) and anxiety/depression (23%); QoL score (mean +/- SD) was 72.1 +/- 16.1 on a total possible score of 100. BPH diagnosis was based on symptoms (93%), digital rectal examination (93%) and abdomino-pelvic ultrasonography (76%). PSA was mentioned for the diagnosis of BPH in 54% of the patients and 77% were receiving pharmacological treatment (61% alpha-blockers) during less than 6 months (38%) or more than a year (35%). CONCLUSIONS: In this study the diagnosis of BPH was mainly based on symptoms, digital rectal examination and abdomino-pelvic ultrasonography. It is worth mentioning that PSA for the diagnosis of BPH, was used in a half of the total number of patients. Pharmacological therapy was used in 3 out of every 4 patients. Compared to a previous national study, there is a change on diagnosis and therapy of BPH.

Características sociosanitarias y diagnósticas del paciente prostático en españa a finales del siglo XX / Sociosanitary and diagnostic characteristics of prostatic patients in Sapin at the end of the 20th century

FUNDAMENTO: Conocer las características sociodemográficas y las pautas reales de diagnóstico y tratamiento del paciente con Hiperplasia Benigna de Próstata (HBP), en España a finales del siglo XX. MÉTODOS: Datos sociodemográficos, clínicos, terapéuticos y de calidad de vida provenientes del estudio ESECI-98, realizado en España (1998-1999) en pacientes con HBP. RESULTADOS: Fueron evaluables 949 pacientes, con una edad (media ñ DE) de 65,6 ñ 7,8 años, con enfermedades concomitantes (40 por ciento), dolor/malestar (34 por ciento) y ansiedad/depresión (23 por ciento); la puntuación de calidad de vida (media ñ DE) fue 72,1 ñ 16,1, sobre 100. El diagnóstico de HBP se basó en anamnesis (93 por ciento), tacto rectal (93 por ciento), y ecografía abdominopélvica (76 por ciento). En un 54 por ciento se mencionó el PSA para el diagnóstico de la HBP. El 77 por ciento estaba recibiendo terapia farmacológica (61 por ciento de ellos alfa-bloqueantes) entre menos de 6 meses (38 por ciento), y más de un año (35 por ciento). CONCLUSIONES: En este estudio el diagnóstico de HBP se basó principalmente en anamnesis, tacto rectal y eco-grafía abdominopélvica. Llama la atención la utilización del PSA en la evaluación diagnóstica de HBP en la mitad de los pacientes. Tres cuartas partes de los enfermos recibían terapia farmacológica. Frente a un estudio previo nacional, se observa una modificación en las pautas de diagnóstico y tratamiento de la HBP en nuestro medio (AU)

Actividad investigadora en vacunas pediátricas en España: análisis descriptivo de los estudios prospectivos publicados entre 1990 y 1998 / Research activity on pediatric vaccines in spain: descriptive analysis of prospective studies published between 1990 and 1998

Objetivo. Describir las características generales de los trabajos prospectivos sobre vacunas en población pediátrica, realizados por investigadores españoles y publicados entre 1990 y 1998. Métodos. A través de una búsqueda bibliográfica en MEDLINE y EMBASE, se han identificado 24 trabajos prospectivos, realizados en España, publicados como originales, y cuyos objetivos estaban directamente relacionados con la administración de vacuna(s) en población pediátrica. Los estudios se agruparon en: ensayos clínicos (grupo A), estudios realizados en el seno de programas de vacunación establecidos (grupo B) y los que no se pueden incluir en los grupos anteriores (grupo C). Resultados. Cinco, 9 y 10 estudios pertenecen a los grupos A, B y C, respectivamente. Participaron más de 12.800 sujetos, pertenecientes tanto a población normal como a grupos de riesgo específicos. Los neonatos y lactantes fueron objeto de 11 estudios. Las vacunas objeto de investigación fueron: hepatitis B (10 estudios), DTPe/Pa (6), SRP (3), gripe (2), Hib (1), hepatitis A (1) y meningococo A y C (1), abordando diversos objetivos (inmunogenicidad y/o seguridad, en la mayoría). Nueve de los trabajos contaron con financiación externa; 21 fueron realizados por investigadores hospitalarios y/o de atención primaria y 18 en el País Vasco, Madrid o la Comunidad Valenciana. Se informó de la obtención del consentimiento informado en 13 publicaciones y de la aprobación del estudio por un comité independiente en 8. Diez estudios fueron publicados en revistas internacionales. Conclusiones. Este trabajo muestra que la mayor parte de los estudios se llevan a cabo por clínicos, con vacunas indicadas para neonatos y lactantes, que no suelen contar con financiación externa, en un reducido número de comunidades autónomas y se suelen publicar en revistas españolas. Sería conveniente que los investigadores sometiesen los protocolos de este tipo de estudios a revisión por un comité ético de investigación clínica, algo que no se hace con tanta asiduidad como la obtención del consentimiento informado (AU)

[Research activity on pediatric vaccines in Spain: descriptive analysis of prospective studies published between 1990 and 1998]. / Actividad investigadora en vacunas pediátricas en España: análisis descriptivo de los estudios prospectivos publicados entre 1990 y 1998.

OBJECTIVE: To describe the overall characteristics of prospective studies on vaccines in children, performed by Spanish investigators and published between 1990 and 1998. METHODS: Through a bibliographic research on MEDLINE and EMBASE, 24 prospective studies, performed in Spain, published as original papers, and with objectives directly related to the administration of vaccines to children have been identified. These studies were grouped as: clinical trials (group A), studies performed on established vaccination programmes (group B), and those that could not be included in the above mentioned groups (group C). RESULTS: 5, 9 and 10 studies belonged to groups A, B and C, respectively. More than 12,800 subjects participated in these studies, belonging to both normal population or specific risk groups. In 11 studies, the study population comprised newborns and infants. The vaccines under investigation were: hepatitis B (10 studies), DTPe/Pa (6), MMR (3), flu (2), Hib (1), hepatitis A (1), and meningococcus A and C (1) to address different objectives (in most of them, immunogenicity and/or reactogenicity). Nine had external financial support; 21 were performed by hospital and/or primary care investigators, and 18 in the Vasque Coutry, Madrid or Valencia. 13 publications reported obtaining informed consent, and 8 on the approval of the study protocol by an independent committee. Ten studies were published by international journals. CONCLUSIONS: This study shows that most of the studies are conducted by clinicians, with vaccines targetted to newborns and infants, with no external financial support, in a small number of autonomous communities, and usually published in Spanish Journals. The submission of this type of studies to a research ethics committee is desirable, something done to a lesser extent than obtaining informed consent.

[Quadrivalent vaccine against diphtheria, tetanus, B. pertussis and hepatitis B: experience in Spain]. / Vacuna tetravalente frente a difteria, tétanos, B. pertussis y hepatitis B: experiencia en España.

OBJECTIVE: The objective of this study was to perform a pooled analysis of the immunogenicity and reactivity results obtained in 2 trials carried out in Spain with a combined DTP-HB vaccine. PATIENTS AND METHODS: Vaccine was administered according to one of two existing vaccination schedules: 2-4-6 and 3-5-7 months of age. Blood samples for antibody determination were obtained 3-6 weeks after the third dose. Anti-diphtheria, anti-tetanus and anti- B. pertussis antibodies were measured by ELISA and anti-HB by radioimmunoassay. Local and general signs and symptoms were recorded by the parents on diary cards for a 4-day follow-up period after each vaccination. RESULTS: A total of 231 infants received three doses of DTP-HB vaccine. All of these doses were accompanied by the corresponding diary card (693 data points for the evaluation of reactogenicity). Two-hundred and nineteen subjects ere included in the analysis of immunogenicity. After the full vaccination course, all subjects had sero-protective titers against diphtheria, tetanus and hepatitis B and were sero-positive of B. pertussis. Geometric mean titers of anti-HB antibodies was 1986 mIU/ml. Pain at the injection site (64%) and unusual crying (71.5%) were the most frequently reported local and general symptoms, respectively. Fever (rectal temperature > or = 38 degrees C) was reported after 46% of the doses, but was considered as severe (> 39.5 degrees C) only in 5 cases. CONCLUSIONS: These results show that this combined DTP-HB vaccine induced a strong immune response to all vaccine components. The safety profile of this DTP-HB is similar to that of classical DTP vaccines.