Protocolización de estudios clínicos multicéntricos en la era digital. ¿Tiene utilidad la centralización de datos por un data-manager? / Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

Introducción En los estudios multicéntricos la protocolización de los datos es una fase crítica que puede generar sesgos, sobre todo en estudios clínicos con presupuesto limitado. El objetivo es analizar la concordancia y la confiabilidad de los datos obtenidos en un estudio multicéntrico clínico entre la protocolización del centro de origen y la protocolización centralizada mediante un data-manager. Método Estudio clínico multicéntrico de prevalencia nacional sobre un carcinoma familiar infrecuente, realizándose una doble protocolización de los datos: a)en el centro de origen, y b)centralizada con un data-manager. La concordancia se analiza para el global de los datos y para los dos subgrupos del proyecto: a)grupo a estudio (carcinoma familiar; protocolizan 30 investigadores) y b)grupo control (carcinoma esporádico; protocolizan 4). Las diferencias interobservador se evalúan mediante el índice de Kappa de Cohen. Resultados Se incluyen 689 pacientes: 252 del grupo a estudio y 437 del grupo control. Respecto al análisis de concordancia del estadio tumoral, se han objetivado un 2,5% de discordancias, siendo alta la concordancia entre protocolizadores (Kappa=0,931). Respecto a la valoración del riesgo de recidiva, las discordancias fueron del 7% de los casos, siendo alta la concordancia (Kappa=0,819). Respecto a la clasificación ecográfica TIRADS, las discordancias son del 6,9% y la concordancia es alta (Kappa=0,922). Se han detectado un 4,6% de errores de transcripción. Conclusiones En los estudios multicéntricos clínicos la protocolización centralizada de los datos por un data-manager parece presentar resultados similares a la protocolización directa en la base de datos en el centro de origen. (AU)

Introduction In multicenter studies, the protocolization of data is a critical phase that can generate biases. The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data-manager. Methods National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (i)center of origin; and (ii)centralized by a data manager. The concordance between the data is analyzed for the global data and for the two groups of the project: (i)study group (familiar carcinoma, 30 researchers protocolize); (ii)control group (sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. Results The study includes a total of 689 patients with carcinoma: 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa=0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa=0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa=0.922). Also, 4.6% of transcription errors were detected. Conclusions In multicenter clinical studies, the centralized data protocolization by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin. (AU)

La población gitana tiene miedos sobre la donación de órganos propios para trasplante / The Roma population's fear of donating their own organs for transplantation

Introducción: La tasa de negativas a la donación entre el pueblo gitano es muy superior a la de cualquier otro grupo social. Objetivo: Analizar la actitud hacia la donación de los órganos propios entre la población gitana residente en España. Métodos: Tipo de estudio: estudio sociológico observacional nacional español estratificado por género y edad. Población a estudio: población gitana con edad≥15 años residente en España. Tamaño muestral: 1.253 encuestados. Instrumento de valoración: cuestionario validado de actitud hacia la donación de órganos para trasplante PCID-DTO Ríos. Trabajo de campo: selección aleatoria en función de la estratificación. Cumplimentación anónima y autoadministrada. Fue precisa la colaboración de personas de etnia gitana. Estadística: test de t de Student, χ2, Fisher y un análisis de regresión logística. Resultados: El grado de cumplimentación fue del 18,2% (n=228). De los que han cumplimentado el cuestionario, están a favor de la donación el 42,1% (n=96), indeciso el 30,3% (n=69) y en contra el 27,6% restante (n=63). De los 1.025 (81,8%) que rechazaron cumplimentar el cuestionario, 1.004 (98%) indicaron que era por miedo a hablar y rellenar un cuestionario que plantee el tema de la muerte y la donación de órganos tras fallecer. Si se considera que los que no han cumplimentado el cuestionario por miedo a la muerte y la donación de órganos tras fallecer no están a favor, los resultados serían los siguientes: el 7,8% (n=96) a favor de donar sus órganos frente al 92,2% (n=1.136) no a favor (en contra o indecisos). Conclusiones: La población gitana presenta un rechazo mayoritario a plantear el tema de la muerte y la donación de órganos tras fallecer. Estos hallazgos muestran que las campañas actuales para promover la donación de órganos no son efectivas en este grupo de población. (AU)

Introduction: The refusal rate for donating organs among the Roma people is much higher than that of any other social group. Objective: To analyze the attitude towards the donation of one's own organs among the Roma population living in Spain. Methods: Type of study: Spanish national observational sociological study stratified by gender and age. Study population: Roma population aged≥15 years living in Spain. Sample size: 1253 respondents. Assessment instrument: validated questionnaire on attitude towards organ donation for transplantation PCID-DTO Ríos. Field work: random selection based on stratification. Anonymous and self-administered completion. The collaboration of people of Roma ethnicity was required. Statistics: Student's t test, χ2, Fisher's exact test and a logistic regression analysis. Results: The degree of completion was 18.2% (n=228). Of those who completed the questionnaire, 42.1% (n=96) were in favor of donation, 30.3% (n=69) were undecided and the remaining 27.6% (n=63) were against it. Of the 1025 (81.8%) who declined to complete the questionnaire, 1004 (98%) indicated that it was for fear of speaking about and filling in a questionnaire that raises the issue of death and organ donation after death. If those who did not complete the questionnaire due to fear of death and donating organs after death are considered not in favor, the results would be as follows: 7.8% (n=96) in favor of donating their organs compared to 92.2% (n=1136) not in favor (against or undecided). Conclusions: A majority of the Roma population prefer not speak of death nor organ donation after death. These findings show that current campaigns to promote organ donation are not effective in this population group. (AU)

The Roma population's fear of donating their own organs for transplantation.

BACKGROUND: The refusal rate for donating organs among the Roma people is much higher than that of any other social group. OBJECTIVE: To analyze the attitude towards the donation of one's own organs among the Roma population living in Spain. METHOD: . TYPE OF STUDY: Spanish national observational sociological study stratified by gender and age. STUDY POPULATION: Roma population aged ≥15 years living in Spain. SAMPLE SIZE: 1,253 respondents. Assessment instrument: Validated questionnaire on attitude towards organ donation for transplantation "PCID - DTO Ríos". Field work: Random selection based on stratification. Anonymous and self-administered completion. The collaboration of people of Roma ethnicity was required. STATISTICS: Student's t test, χ2, Fisher's exact test and a logistic regression analysis. RESULTS: The degree of completion was 18.2% (n = 228). Of those who completed the questionnaire, 42.1% (n = 96) were in favor of donation, 30.3% (n = 69) were undecided and the remaining 27.6% (n = 63) were against it. Of the 1,025 (81.8%) who declined to complete the questionnaire, 1,004 (98%) indicated that it was for fear of speaking about and filling in a questionnaire that raises the issue of death and organ donation after death. If those who did not complete the questionnaire due to fear of death and donating organs after death are considered not in favor, the results would be as follows: 7.8% (n = 96) in favor of donating their organs compared to 92.2% (n = 1166) not in favor (against or undecided). CONCLUSIONS: A majority of the Roma population prefer not speak of death nor organ donation after death. These findings show that current campaigns to promote organ donation are not effective in this population group.

Attitude Toward Organ Donation Among Cuban Residents in Florida.

BACKGROUND: The Cuban population residing in the state of Florida in the United States forms the largest population group of immigrants in that state. It has been described as a population with little awareness of organ donation. The objective is to analyze the factors that Cubans residing in the Florida refer to when expressing an unfavorable attitude toward organ donation and to determine the psychosocial factors associated with the attitude toward organ donation of this population group. METHODS: We performed a cross-sectional observational study. From the Proyecto Colaborativo Internacional Donante (International Donor Collaborative Project), a sample stratified by age and sex of Cubans residing in Florida (N = 1224) is obtained. The sample is analyzed using the validated questionnaire (PCID-DTO-RIOS). The reasons against organ donation were analyzed using a specific multiresponse item, with an open response option. For the analysis of the psychosocial variables, a logistic regression analysis is carried out. RESULTS: A total of 38.2% (n = 468) of the individuals under study declared themselves against organ donation. Of those who were against, the reasons stated were (1) leave the dead in peace (n = 440; 57.6%); (2) religious reasons (n = 192; 25.1%); (3) fear of mutilation (n = 160; 20.9%); (4) assertive refusal (n = 128; 16.8%); (5) apparent death (n = 16; 2.1%); and (6) other reasons (n = 764; 62.4%). CONCLUSIONS: The Cuban population residing in Florida who is against organ donation expresses various reasons. In addition, there are factors associated with the psychosocial profile toward organ donation of this important population group.

The Willingness to Donate Organs in Medical Students From an International Perspective: A Meta-Analysis.

Attitude toward organ donation mobilizes donation behavior and makes transplant surgery possible. As future health professionals, medical students will be a relevant generating opinion group and will have an important role in the organ requesting process. The goals of this meta-analysis were to obtain polled rates of medical students who are in favor, against, or indecisive toward cadaveric organ donation in the studies conducted around the world, and to explore sociocultural variables influencing the willingness to donate. Electronic search and revision of references from previous literature allowed us to locate 57 studies fulfilling the inclusion criteria. Data extraction and risk of bias assessment were performed by two independent investigators. Pooled estimations were computed assuming a random-effects model. Despite the fact that willingness to donate was elevated in medical students, estimated rates in studies from different geographical areas and sociocultural backgrounds exhibited significant differences. The age and the grade of the students also influenced the rate of students in favor. Donation campaigns should take into account cultural factors, especially in countries where certain beliefs and values could hamper organ donation. Also, knowledge and skills related to organ donation and transplant should be acquired early in the medical curriculum when a negative attitude is less resistant to change.

International Population Study in Spain, Cuba, and the United States of Attitudes Toward Organ Donation Among the Cuban Population.

Cuban immigrants constitute an important group in both the United States and Spain, with different behaviors toward organ donation having been described among the different Latin American nationalities. We analyzed the attitude toward organ donation among the Cuban populations in Cuba, Spain, and Florida. The study population was Cuban immigrants over 15 years of age residing in Cuba, Spain, and Florida, with samples randomly stratified by age and sex. A validated questionnaire on psychosocial aspects of organ donation (PCID-DTO Rios) was used. Census was used as the sampling base in all 3 countries; however, additionally, in Spain and the United States (Florida), we sought the support of immigration support associations to determine the Cuban population without legal documentation. The questionnaire was completed anonymously and self-administered. The completion rate of the study was 74% (4123/5574) among 424 surveyed in Spain, 1224 in Florida, and 2475 in Cuba. The attitude in favor of donating their own organs upon death was 60.6% of those surveyed in Spain, 37.6% in Florida, and 68.9% in Cuba, or 58% of the global sample. Multivariate analysis showed that country of residence was an independent factor associated with attitude toward organ donation (odds ratio, 1.929). Other factors associated with attitude were sex, educational level, performance of prosocial activities, knowledge of the brain death concept, religion, the couple's opinion toward donation, fear of mutilation after donation, and attitude toward manipulation of the body after death. The attitude toward organ donation among Cubans in their country of origin and immigrants in Spain was similar, being significantly different from those who emigrate to Florida, where the attitude is much less favorable.

Emotional changes in men treated with sildenafil citrate for erectile dysfunction: a double-blind, placebo-controlled clinical trial.

INTRODUCTION: Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem. AIM: In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions. METHODS: This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in men aged >or=18 years with a clinical diagnosis of ED (score

Giannini prosthesis for flatfoot.

BACKGROUND: To determine the clinical and radiographic results of arthroereisis using the Giannini endo-orthotic implant for the treatment of pediatric flatfoot deformity, we retrospectively evaluated 37 patients (65 feet). METHODS: Twenty-two boys and 15 girls were followed for an average of 26.5 months. Their overall average age was 9.4 (range 5 to 14) years. Pain, function, participation in sports activity, and the changes in radiographic measurements taken at 3, 6, and 12 months and then at 1-year intervals were evaluated. RESULTS: Pain or discomfort decreased from 60% (22 patients) preoperatively to 6% (2 patients) postoperatively. The percentage of normal postoperative footprints was 59% (38 feet) with first-degree flatfoot present in 27 feet (41%). Sports activities were taken up by 19 patients (51%) after surgery. An 8-mm endo-orthotic implant was used in 43 (66%) feet and an Achilles tenotomy was done in 38 feet (59%). The radiographic angles with the greatest degree of correction when compared to preoperative angles were the talar-first metatarsal angle (99%) and the calcaneal-pitch (36%). After placement of the endo-orthotic implant, the talar angle influenced the rest of the radiographic measurements. There was no postoperative deterioration in any of the radiographic angles measured during the monitoring period. Complications occurred in 10.7% of the patients, with postoperative pain being the most frequently reported (6% of patients). There was no infection or local reaction to a foreign body. Removal of the endo-orthotic implant was not done on a routine basis. CONCLUSION: This operative technique respects the anatomical structure of the foot and produces good clinical and radiographic results.