Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos / Design and validation of 2 instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products

Objetivo: la actividad de los promotores y Comités de Ética de la Investigación con medicamentos ha aumentado en los últimos años. El objetivo fue diseñar y validar 2 instrumentos para analizar y evaluar la calidad formal de la hoja de información al participante y el formulario de consentimiento informado de ensayos clínicos con medicamentos, acorde con la legislación.Métododiseño (Buenas Prácticas Clínicas y normativas europea y española); validación (método Delphi y consenso de expertos: concordancia ≥ 80%); fiabilidad (método inter-observadores, índice Kappa). 40 hojas de información al participante/consentimientos informados evaluados.Resultadosse obtuvo muy buena concordancia en ambos instrumentos (k ≥ 0,81, p < 0,001). Las versiones definitivas estaban formadas por: checklist-hoja de información al participante: 5 secciones, 16 ítems y 46 sub-ítems; checklist-consentimiento informado: 11 ítems.Conclusioneslos instrumentos desarrollados son válidos, fiables y facilitan el análisis, la evaluación y la toma de decisión sobre las hojas de información al participante/consentimientos informados de ensayos clínicos con medicamentos. (AU)

Objective: The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation.MethodDesign (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated.ResultsVery good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items.ConclusionThe instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs. (AU)

[Translated article] Design and validation of two instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products.

OBJECTIVE: The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation. METHODS: Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated. RESULTS: Very good concordance was obtained in both checklists (k ≥ 0.81, p b 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items. CONCLUSION: The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

Design and validation of 2 instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products. / Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos.

OBJECTIVE: The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation. METHOD: Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated. RESULTS: Very good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items. CONCLUSION: The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

Cross-cultural adaptation and validation of the Recognizing And Addressing Limited Pharmaceutical Literacy (RALPH) interview guide in community pharmacies.

BACKGROUND: The RALPH (Recognizing and Addressing Limited PHarmaceutical Literacy) interview guide makes it possible to identify patients with limited pharmaceutical knowledge and to assess their skills in the functional, communicative, and critical health literacy domains. OBJECTIVE: (s): To perform a cross-cultural validation of the RALPH interview guide in Spanish population; to conduct a descriptive analysis based on patients' responses. METHODS: A cross-sectional study of patients' pharmaceutical literacy skills was conducted in three stages: systematic translation, administration of the interview and analysis of psychometric properties. The target population included adult patients (≥18 years) who attend one of the participating community pharmacies in Barcelona (Spain). Content validity was evaluated by an expert committee. Viability was assessed in the pilot test, and reliability was assessed using internal consistency and intertemporal stability. Construct validity was assessed by factor analysis. RESULTS: A total of 103 patients were interviewed at 20 pharmacies. Cronbach's alpha values based on standardized items ranged between 0.720 and 0.764. For the longitudinal component, the ICC test-retest reliability was 0.924. The factor analysis was verified by KMO (0.619) and Bartlett's test of sphericity (P-value <0.05). The definitive RALPH guide translated into Spanish maintains the same structure as the original. Some expressions were simplified, and the questions on the comprehension of warnings or specific instructions for use, contradictory information and shared decision-making were reformulated. Pharmaceutical literacy skills were seen to be most limited with regard to the critical domain. The responses of the Spanish patients were in agreement with the original results of the RALPH interview guide. CONCLUSIONS: The RALPH interview guide in Spanish complies with the requirements viability, validity, and reliability. This tool may be able to identify the low pharmaceutical literacy skills of patients coming to community pharmacies in Spain, and its use may also be extended to other Spanish-speaking countries.

Development and Validation of the Hospital Outpatients' Information Needs Questionnaire (HOINQ).

PURPOSE: The main objective was to develop and validate a "Hospital Outpatients' Information Needs Questionnaire" (HOINQ). Secondly, to identify patients' preferred sources of information. Finally, to establish differences depending on the disease, as well as between sociodemographic and clinical variables. PATIENTS AND METHODS: This is a transversal study based on a questionnaire. All adult hospital outpatients' who collected their medication at the Pharmacy Service were consecutively recruited, regardless of their diagnosis time, treatment or disease. The Spanish version of the internationally validated European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ-25) aimed at oncology patients was used as the starting point. In order to be applicable on new target population, it was crucial to make several changes and ensure that it complies with the validity, viability and reliability criteria. The questionnaire prepared for validation was then obtained by a literature review (face validity), submitting the EORTC QLQ-25 to an expert committee (content validity), by piloting (viability) and Cronbach's alpha statistical analysis (reliability). Once the questionnaire was completed, Cronbach's alpha of the final study (reliability) and factor analysis (construct validity) were performed. Then, pertinent modifications were applied to obtain the HOINQ. RESULTS: A total of 153 outpatients filled the questionnaire, which was widely accepted and required 5-10 min to complete. Cronbach's alpha coefficients met criteria >0.7. Three factors were established by factor analysis: aspects about the disease, pharmacological and no-pharmacological treatment and satisfaction and perception of the information received. Participants felt satisfied (41-52%) with the information amount, quality and usefulness, although 1 out of 3 stated wanting to know more about the different information areas. Younger patients (P-value <0.05) and those who had been attending the Pharmacy Service for a longer time span (P-value <0.01) reported receiving more information. On a 0 to 7 scale, medical specialists (mean = 6.28, SD = 1.38) followed by the rest of health care professionals (mean = 4.23-4.63, SD = 2.25-2.29) were selected as the preferred sources of information. HIV patients reported being more informed, while those with rheumatoid arthritis felt less informed (P-value <0.05). CONCLUSION: The HOINQ was developed. It is a self-completed questionnaire, composed of three blocks: the 16-item information needs questionnaire, demographic and clinical variables, and patients' preferred sources of information. It is an easy tool to use and replicate, both for patients and professionals.

Estudio cuasi experimental sobre la efectividad de la musicoterapia para reducir la ansiedad ante una técnica intervencionista en la unidad del dolor / Quasi-experimental study on effectiveness of music therapy to reduce anxiety before an interventional technique in the pain unit

OBJETIVOS: Valorar la eficacia de la musicoterapia en la disminución de la ansiedad en pacientes a los que se les realiza técnica intervencionista (TI) en la Unidad del Dolor (UD) del Hospital Universitario Sagrat Cor de Barcelona. MATERIAL Y MÉTODO: Estudio cuasi experimental con grupo control, prospectivo, pre y postintervención, transversal, no aleatorizado. Aprobado por el Comité Ético de Investigación IDC Salud Catalunya. Población estudio: pacientes programados para realización de TI en la UD. Criterios inclusión: > 18 años de edad. Indicación de TI. Criterios exclusión: trastorno psiquiátrico, incapacidad contestar variables de estudio. Grupo intervención: se ha realizado la TI reproduciéndose aleatoriamente la música elegida, libre de contaminación acústica. Grupo control: se ha realizado la TI sin musicoterapia. Se ha empleado la escala visual análoga modificada como instrumento de medida para valorar el nivel de ansiedad. RESULTADOS: 80 pacientes (71,6 % mujeres, media de edad 66,7 [SD 14] años, 49,4 % estudios medios, 64,2 % pensionistas). El 60,5 % no realiza tratamiento con ansiolíticos. El 59 % presenta lumborradiculalgia, se les realiza bloqueo epidural caudal. Al 33,3 % se les realiza técnica intervencionista por primera vez. En el grupo control el valor de EVA intra es de 5,83 (SD 3,2) y en el grupo de musicoterapia de 5,0 (SD 2,2), esta diferencia no es estadísticamente significativa (F = 1,614, p = 0,208). En el valor de EVA postintervención sucede lo mismo. En el grupo control el valor de EVA post es de 3,7 (SD 3,3) y en el grupo de musicoterapia de 3,1 (SD 2,4); esta diferencia no es estadísticamente significativa (F = 0,755, p = 0,387). En el grupo control el valor de la escala visual analógica intra es de 4,3 (SD 3,1) y en el grupo de musicoterapia de 3,0 (SD 2,0), esta diferencia sí es estadísticamente significativa (F = 4,83, p = 0,031). En el grupo control el valor de la escala visual analógica post es de 2,7 (SD 2,8) y en el grupo de musicoterapia de 1,3 (SD 1,5); esta diferencia también es estadísticamente significativa (F = 7,427, p = 0,008). El 81,5 % considera que ha recibido suficiente información sobre la técnica intervencionista y el 18,5 % están satisfechos. El 95,1 % considera que los profesionales le han aportado confianza y seguridad y el 4,9 % restante se consideran satisfechos. De los que han valorado (40 pacientes) si la música ha creado un ambiente relajado el 80 % se consideran muy satisfechos y el 20 % restante satisfechos. CONCLUSIÓN: Aunque el dolor no se ve mejorado significativamente en el grupo intervencionista sí lo hace la ansiedad tanto en la fase intra como en la post TI. Los pacientes se sienten muy satisfechos sobre la información recibida y consideran muy satisfactoria la confianza y seguridad que les aportan los profesionales. Además, el grupo de musicoterapia considera, en general, muy satisfactorio el ambiente relajado que les crea la música. La musicoterapia es una excelente herramienta terapéutica, fácil de usar, accesible y económica, que puede utilizarse como coadyuvante en las TI en la UD

OBJECTIVE: To assess the efficacy of music therapy in reducing anxiety in patients undergoing interventional technique (IT) in the Pain Unit (UD) of the University Hospital Sagrat Cor in Barcelona. MATERIAL AND METHOD: Quasi-experimental study with a control group, prospective, pre- and post-intervention, transversal, non-randomized. Approved by the Research Ethics Committee IDC Salud Catalunya. Study population: patients scheduled to perform IT in the UD. Inclusion criteria: > 18 years old. IT indication. Exclusion criteria: psychiatric disorder, inability to answer study variables. Intervention group: IT has been performed by randomly playing the chosen music, free of noise pollution. Control group: IT has been performed without music therapy. The modified analog visual scale has been used as a measuring instrument to assess the level of anxiety. RESULTS: 80 patients (71.6 % women, mean age 66.7 (SD 14) years, 49.4 % average studies, 64.2 % pensioners). 60.5 % do not perform treatment with anxiolytics. 59 % have low back pain, caudal epidural block is performed. 33.3 % underwent interventional technique for the first time. In the control group the value of intra VAS is 5.83 (SD 3.2) and in the music therapy group 5.0 (SD 2.2), this difference is not statistically significant (F = 1.614, p = 0.208). The same happens in the value of post-intervention EVA. In the control group the value of post VAS is 3.7 (SD 3.3) and in the music therapy group 3.1 (SD 2.4), this difference is not statistically significant (F = 0.755, p = 0.387). In the control group the value of the intra analog visual scale is 4.3 (SD 3.1) and in the music therapy group 3.0 (SD 2.0), this difference is statistically significant (F = 4, 83 p = 0.031). In the control group the value of the post analog visual scale is 2.7 (SD 2.8) and in the music therapy group 1.3 (SD 1.5), this difference is also statistically significant (F = 7.427, p = 0.008). 81.5 % consider that they have received enough information about the interventionist technique and 18.5 % are satisfied. 95.1 % consider that the professionals have given him confidence and security and the remaining 4.9 % are considered satisfied. Of those who have assessed (40 patients) if music has created a relaxed atmosphere, 80% are considered very satisfied and the remaining 20 % satisfied. CONCLUSION: Although pain is not significantly improved in the interventionist group, anxiety does in both the intra and post-IT phases. Patients feel very satisfied about the information received and consider the confidence and security provided by professionals very satisfactory. In addition, the music therapy group considers, in general, the relaxed atmosphere created by the music. Music therapy is an excellent therapeutic tool, easy to use, accessible and economical, which can be used as an adjunct in IT in the UD

Conceptos de nutrición enteral en geriatría (II) / No disponible

No disponible

Nutrición enteral en Geriatría / No disponible

No disponible

Compliance with local guidelines for antibiotic prophylaxis in surgery.

OBJECTIVES: To describe the development and implementation of a local protocol for antibiotic prophylaxis in surgery and to assess compliance with these guidelines using a computer-based system. DESIGN: One 5-week prospective period (phase 1) followed by three 1-week, cross-sectional assessments (phases 2, 3, and 4). SETTING: Pharmacy of a 350-bed acute care teaching hospital in Barcelona, Spain. METHODS: In phase 1, 395 forms for antibiotic prescribing delivered to the pharmacy were reviewed. Nonadherence was defined as the prescription of an antibiotic (or doses) different from what the protocol specified. In phases 2, 3, and 4, antibiotic prescribing forms for all elective procedures (630 patients) performed during 1-week periods were analyzed. RESULTS: A total of 1,047 patients (mean age, 58.9 +/- 17.3 years) were included. Cefazolin was administered in 41% of procedures. Overall compliance with antibiotic prescribing forms was 83.3%. There was a statistically significant increase in compliance with guidelines throughout the four phases of the study, from 80.3% in phase 1 to 87.8% in phase 4 (P < .042), as well as adherence to completing forms for surgical procedures, from 51% in phase 2 to 77.6% in phase 4 (P < .001). The main reason for non-adherence was that some procedures had not been included in the protocol in phase 2. CONCLUSION: Surgeons sensitized to the implementation of local antibiotic prophylaxis guidelines showed a high degree of compliance with them, using both the procedure established for antibiotic prescribing and the antimicrobials recommended for particular operations