[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners]. / Ensayos clínicos y consentimiento informado: visión de investigadores, pacientes y médicos de familia.

OBJECTIVE: Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. DESIGN: A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. SETTING: GPs, researchers and patients involved in clinical trials. PARTICIPANTS: Included, 504 GPs, 108 researchers, and 71 patients. RESULTS: Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. CONCLUSIONS: GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation.

Clinical remission and subsequent relapse in patients with juvenile idiopathic arthritis: predictive factors according to therapeutic approach.

BACKGROUND: Juvenile idiopathic arthritis constitutes a significant cause of disability and quality of life impairment in pediatric and adult patients. The aim of this study was to ascertain clinical remission (CR) and subsequent relapse in juvenile idiopathic arthritis (JIA) patients, according to therapeutic approach and JIA subtype. Evidence in literature regarding its predictors is scarce. METHODS: We conducted an observational, ambispective study. Patients diagnosed of JIA, treated with synthetic and/or biologic disease modifying antirheumatic drugs (DMARD) were included and followed-up to December 31st, 2015. Primary outcome was clinical remission defined by Wallace criteria, both on and off medication. In order to ascertain CR according to therapeutic approach, DMARD treatments were divided in four groups: 1) synthetic DMARD (sDMARD) alone, 2) sDMARD combined with another sDMARD, 3) sDMARD combined with biologic DMARD (bDMARD), and 4) bDMARD alone. RESULTS: A total of 206 patients who received DMARD treatment were included. At the time the follow-up was completed, 70% of the patients in the cohort had attained CR at least once (144 out of 206), and 29% were in clinical remission off medication (59 out of 206). According to treatment group, CR was more frequently observed in patients treated with synthetic DMARD alone (53%). Within this group, CR was associated with female sex, oligoarticular persistent subtypes, ANA positivity, Methotrexate treatment and absence of HLA B27, comorbidities and DMARD toxicity. 124 DMARD treatments (62%) were withdrawn, 64% of which relapsed. Lower relapse rates were observed in those patients with persistent oligoarticular JIA (93%) when DMARD dose was tapered before withdrawal (77%). CONCLUSIONS: More than two thirds of JIA patients attained CR along the 9 years of follow-up, and nearly one third achieved CR off medication. Females with early JIA onset, lower active joint count and ANA positivity were the ones achieving and sustaining remission more frequently, especially when receiving synthetic DMARD alone and in the absence of HLA B27, comorbidities or previous DMARD toxicity.

Gut Microbiota Bacterial Species Associated with Mediterranean Diet-Related Food Groups in a Northern Spanish Population.

The MD (Mediterranean diet) is recognized as one of the healthiest diets worldwide and is associated with the prevention of cardiovascular and metabolic diseases. Dietary habits are considered one of the strongest modulators of gut microbiota, which seem to play a significant role in health status of the host. The purpose of the present study was to evaluate interactive associations between gut microbiota composition and habitual dietary intake in 360 Spanish adults from the Obekit cohort (normal weight, overweight, and obese participants). Dietary intake and adherence to the MD tests were administered and fecal samples were collected from each participant. Fecal 16S rRNA (ribosomal Ribonucleic Acid) gene sequencing was performed and checked against the dietary habits. MetagenomeSeq was the statistical tool applied to analyze data at the species taxonomic level. Results from this study identified several beneficial bacteria that were more abundant in the individuals with higher adherence to the MD. Bifidobacterium animalis was the species with the strongest association with the MD. Some SCFA (Short Chain Fatty Acids) -producing bacteria were also associated with MD. In conclusion, this study showed that MD, fiber, legumes, vegetable, fruit, and nut intake are associated with an increase in butyrate-producing taxa such as Roseburia faecis, Ruminococcus bromii, and Oscillospira (Flavonifractor) plautii.

Predictive factors of hyperglycaemia in patients with parenteral nutrition. / Factores predictores de hiperglucemia en pacientes con nutrición parenteral.

OBJECTIVE: To identify the predictive factors of hyperglycaemia in patients receiving parenteral nutrition (PN). MATERIAL AND METHODS: Retrospective observational study (January 2016-December 2016) conducted in a 450-bed university hospital. Adult hospitalized patients who received total PN through a central line for at least 48hours were included. The required variables to characterize patients, and those related to the PN received were collected and hyperglycaemia was defined as 3 consecutive glycaemias greater than 150mg/dl or 2 greater than 180mg/dl. A descriptive, comparative bivariate statistical analysis was carried out, as well as a multivariate analysis using binary logistic regression (SPSS.v.24.) RESULTS: 234 patients were included. The prevalence of hyperglycaemia in the population under study was 44.0%. The main differences observed in the bivariate analysis between hyperglycaemic and normoglycemic patients were related to age, previous comorbidities, medical department, presence of sepsis, duration and glucose contribution in PN, as well as blood glucose levels and corticosteroids. The predictors of hyperglycaemia obtained after the multivariate analysis were: renal clearance (OR=.982, 95% CI .968-.996, P=.010), pre-PN glycaemia (OR=1.039, 95% CI 1.026-1.051, P<.001), diabetes mellitus (OR=11.016, 95% CI 3.028-31.697, P<.001), intensive medicine (OR=3.303, 95% CI 1.183-9.219, P=.023), corticosteroids (OR=3.155, 95% CI 1.179-8.226, P=.022). CONCLUSIONS: Decreased renal clearance, high blood glucose levels, diabetes, corticosteroid use, and critical patients are predictors of hyperglycaemia, therefore it would be advisable to consider them in the design of PN start formula.

Orbital cavernous haemangioma; profile and outcome of 76 patients managed surgically.

Background: Orbital cavernous haemangioma (OCH) is one of the most common primary orbital tumours in adults. They can encroach on intraorbital or adjacent structures and be considered 'anatomically' malignant. Aims: To report a series of patients that were all managed surgically, with possible specificities and propose predictors of treatment outcome. Methods: We realised a hospital-based retrospective case review including data from 76 patient files. Results: The mean age was 37.8 years. Unilateral proptosis was observed in all patients. Visual loss was found in 32 patients (42.1%). Findings on eye examination included lagophthalmos (76.3%), blepharoptosis (21.1%), complications of corneal exposure (19.6%), strabismus (13.2%) and fundoscopic abnormalities (60.5%). Abnormal fundoscopy was significantly associated with decreased visual acuity (VA) (p < .001). Small tumours were predominant (65.8%) and size was associated with VA (correlation coefficient r = -0.5, p < .001). Surgery was mainly by lateral orbitotomy (94.7%), with early post-operative complications in 18 patients (23.7%). Multivariable analysis showed that tumour size, preoperative VA and abnormal fundoscopy were significantly associated with postoperative VA. Conclusion: Clinical and radiological profiles are consistent. Tumour size, preoperative VA, and abnormal fundoscopy seem to be important factors that could influence outcome expectations. Surgical management is still predominantly by open approaches. Severe complications remain rare.

Heparinized solution vs. saline solution in the maintenance of arterial catheters: a double blind randomized clinical trial.

OBJECTIVES: The objectives were to analyze the effectiveness of heparinized solution vs. saline solution for the maintenance of arterial catheters and to detect changes in the activated partial thromboplastin time (aPTT) and platelet count in the samples extracted from both groups of arterial catheters. DESIGN: Randomized, double blind, placebo-controlled clinical trial. SETTING: Intensive Care Unit of a third-level hospital in Terrassa, Barcelona, Spain. PATIENTS: One hundred and thirty-three patients were included in the trial. The selection criteria were: adults, informed consent, not receiving either full-dose anticoagulant or fibrinolytic treatment, and no thrombocytopenia. INTERVENTIONS: Sixty-five patients received heparinized solution (1 IU/ml) and 68 received saline solution. MEASUREMENTS: Arterial catheter functionality was compared in the groups every 8 h and at catheter removal. Patency, reliability of arterial pressure, and curve quality were used to evaluate the functionality of the catheters. Blood was drawn, discarding 7.5 ml, from the arterial catheter and from the venouscatheter simultaneously for coagulation tests. RESULTS: The median duration of catheters being in place was 5.1 days (IQR = 8.1) in the heparin group, and 5.4 (IQR = 7.3) in the saline group (p = 0.7). Kaplan-Meier curves showed no differences between groups (p = 0.6). The number of manipulations required to maintain the patency of the arterial catheters was 35% vs. 40% (p = 0.5). The heparin group had a significantly longer aPTT (2.1 +/- .3 vs. 1.25 +/- 0.3, p = 0.001). CONCLUSIONS: The use of heparinized solution for arterial catheter maintenance doesnot appear to be justified. It did not increase the duration of the catheters, nor did it improve their functionality significantly. On the other hand, heparin Na altered aPTT significantly.

Ethical Challenges of Early Identification of Advanced Chronic Patients in Need of Palliative Care: The Catalan Experience.

Palliative care must be early applied to all types of advanced chronic and life limited prognosis patients, present in all health and social services. Patients' early identification and registry allows introducing palliative care gradually concomitant with other measures. Patients undergo a systematic and integrated care process, meant to improve their life quality, which includes multidimensional assessment of their needs, recognition of their values and preferences for advance care planning purposes, treatments review, family care, and case management. Leaded by the National Department of Health, a program for the early identification of these patients has been implemented in Catalonia (Spain). Although the overall benefits expected, the program has raised some ethical issues. In order to address these challenges, diverse institutions, including bioethics and ethics committees, have elaborated a proposal for the program's advantages. This paper describes the process of evaluation, elaboration of recommendations, and actions done in Catalonia.

Assessing practical skills in cardiopulmonary resuscitation: Discrepancy between standard visual evaluation and a mechanical feedback device.

This paper aims to analyze agreement in the assessment of external chest compressions (ECC) by 3 human raters and dedicated feedback software.While 54 volunteer health workers (medical transport technicians), trained and experienced in cardiopulmonary resuscitation (CPR), performed a complete sequence of basic CPR maneuvers on a manikin incorporating feedback software (Laerdal PC v 4.2.1 Skill Reporting Software) (L), 3 expert CPR instructors (A, B, and C) visually assessed ECC, evaluating hand placement, compression depth, chest decompression, and rate. We analyzed the concordance among the raters (A, B, and C) and between the raters and L with Cohen's kappa coefficient (K), intraclass correlation coefficients (ICC), Bland-Altman plots, and survival-agreement plots.The agreement (expressed as Cohen's K and ICC) was ≥0.54 in only 3 instances and was ≤0.45 in more than half. Bland-Altman plots showed significant dispersion of the data. The survival-agreement plot showed a high degree of discordance between pairs of raters (A-L, B-L, and C-L) when the level of tolerance was set low.In visual assessment of ECC, there is a significant lack of agreement among accredited raters and significant dispersion and inconsistency in data, bringing into question the reliability and validity of this method of measurement.

Neuropsychological Outcome One Year after Carotid Revascularization: A before-and-after Study.

PURPOSE: The aim of our study was to determine the clinical profile of patients considered cognitive 'responders' to surgery in order to establish clinical variables associated with a favorable cognitive performance. MATERIALS AND METHODS: A total of 70 patients were included in the study. A well-validated, comprehensive standardized neurocognitive battery of tests of about 2 hours was administered. Patients were examined twice, 1-week before surgery and 1-year postoperatively. The criterion to be included in the 'responder' group was the following: to obtain a positive difference between post-revascularization and pre-revascularization neuropsychological assessment ≥1 standard deviation in ≥2 tests. RESULTS: Twenty-seven patients (38.6%) were cognitive responders to treatment. In bivariate analysis between responders and non-responders, presence of atrophy (P=0.003), small vessels (P=0.577), symptoms (P=0.046), and age (P=0.030) were the factors statistically significant. When comparing cognitive performance before and after carotid revascularization, significant differences were observed in semantic fluency with a lower performance after 12 months (P=0.004, d=0.29), and in the Language index (Repeatable Battery for the Assessment of Neuropsychological Status) (P=0.005, d=0.34). CONCLUSION: Patients without neurological symptoms, of a younger age and without atrophy and white matter small vessel lesions are better cognitive responders 1-year after carotid revascularization.

[Spanish versions of the Simplified Motor Score and the Glasgow Coma Scale in out-of-hospital treatment of head injury in adults: a preliminary study of each scale's ability to predict adverse events]. / Estudio comparativo preliminar entre la Puntuación Motora Simplificada modificada y la Escala de Coma de Glasgow en pacientes adultos atendidos por traumatismo craneoencefálico en el ámbito extrahospitalario.

OBJECTIVES: To determine the ability of the modified (Spanish) version of the Simplified Motor Score (mSMS) to predict adverse events during hospitalization and to compare its predictive ability to that of the Glasgow Coma Scale (GCS) in adults with head injuries treated outside the hospital. MATERIAL AND METHODS: Observational study of retrospective cohorts including all patients over the age of 14 years attended for head injuries occurring within 24 hours of treatment by an advanced life-support unit staffed by nurses between May 1, 2013, and May 1, 2014. The mSMS was a translation of the English original, created through a process of discussions of direct and back translations to arrive at consensus. Out-of-hospital patient records were searched to find GCS and mSMS scores. To predict the ability of each scale to predict brain injuries, neurosurgery, intubation, and/or inhospital death, we calculated the area under the receiving operator characteristic curves (AUCs). RESULTS: Of the total of 115 head-injury patients attended, 64 met the inclusion criteria. The mean (SD) age was 47 (24) years. Twelve (18.8%) patients developed some form of adverse event during hospitalization; 91.6% had brain damage, 58.3% required intubation, 8.3% required surgery, and 41.6% died. The AUC for the GCS was 0.907 (95% CI, 0.81-1.00; P<.001); the AUC for the mSMS was 0.796 (95% CI, 0.64-0.95; P=.001). CONCLUSION: Although the ability of the mSMS to predict in-hospital adverse outcomes is good, it is inferior to the GCS in adults with head injuries attended outside the hospital.

OBJETIVO: Determinar la capacidad predictiva de resultados adversos durante la hospitalización de la escala Simplified Motor Score (SMS) adaptada al español (Puntuación Motora Simplificada modificada, PMSm), y compararla con la Escala del Coma de Glasgow (ECG) en los pacientes adultos atendidos por traumatismo craneoencefálico en el ámbito extrahospitalario. METODO: Estudio observacional de cohortes retrospectivo que incluyó a todo paciente mayor de 14 años atendido por un traumatismo craneoencefálico de menos de 24 horas de evolución en una unidad de soporte vital avanzado con enfermería entre el 1 de mayo de 2013 y el 1 de mayo de 2014. Se realizó una traducción directa-inversa de la SMS por consenso formal obteniendo la PMSm. Se recogieron a partir de las historias clínicas de la atención extrahospitalaria los datos de la ECG desglosada y la PMSm. Se calculó el área bajo la curva (ABC) COR de la PMSm y la ECG para la predicción de lesión cerebral, necesidad de intervención neuroquirúrgica y/o de intubación y mortalidad durante la hospitalización. RESULTADOS: Del total de 115, se incluyeron finalmente 64 pacientes con una edad media de 47 (DE 24) años. Doce pacientes (18,8%) presentaron algún resultado adverso (91,6% lesión cerebral, 58,3% necesidad de intubación, 8,3% necesidad de intervención quirúrgica y 41,6% fallecieron) durante la hospitalización. El ABC COR de la puntuación ECG fue 0,907 (IC 95%: 0,81-1,00; p < 0,001) y de la PMSm fue 0,796 (IC 95%: 0,64-0,95; p = 0,001). CONCLUSIONES: La capacidad predictiva de resultados adversos durante la hospitalización de la PMSm es buena pero inferior a la ECG en los pacientes adultos atendidos por traumatismo craneoencefálico en el ámbito extrahospitalario.

Low compliance with the 2 minutes of uninterrupted chest compressions recommended in the 2010 International Resuscitation Guidelines.

BACKGROUND: We aimed to analyze compliance with 2010 European guidelines' quality criteria for external chest compressions (ECC) during 2 minutes of uninterrupted cardiopulmonary resuscitation. METHODS: Seventy-two healthy nurses and physicians trained in advanced cardiopulmonary resuscitation performed 2 uninterrupted minutes of ECC on a training manikin (Resusci Anne Advanced SkillTrainer; Laerdal Medical AS, Stavanger, Norway) that enabled us to measure the depth and rate of ECC. When professionals agreed to participate in the study, we recorded their age, body mass index (BMI), smoking habit, and their own subjective estimation of their physical fitness. To measure fatigue, we analyzed participants' heart rates, percentage of maximum tolerated heart rate (MHR), and subjective perception of their fatigue on a visual analog scale. RESULTS: Nearly half (48.6%) the rescuers failed to achieve a minimum average ECC depth of 50 mm. Only 48.1% of ECCs fulfilled the 2010 guidelines' quality criteria; quality deteriorated mainly after the first minute. Poor ECC quality and deteriorating quality after the first minute were associated with BMI < 23 kg/m(2). Rescuers with BMI ≥ 23 kg/m(2) fulfilled the quality criteria throughout the 2 minutes, whereas those with BMI < 23 kg/m(2) fulfilled them for 80% of ECCs during the first minute, but for only 30% at the end of the 2 minutes. CONCLUSIONS: Compliance with the 2010 guidelines' quality criteria is often poor, mainly due to lack of proper depth. The greater depth recommended in the 2010 guidelines with respect to previous guidelines requires greater force, so BMI < 23 kg/m(2) could hinder compliance. Limiting each rescuer's uninterrupted time doing ECC to 1 minute could help ensure compliance.

Mortality after hospitalization for COPD.

OBJECTIVES: To identify variables associated with mortality in patients admitted to the hospital for acute exacerbation of COPD. DESIGN: Prospective cohort study. SETTING: Acute-care hospital in Barcelona (Spain). PATIENTS: One hundred thirty-five consecutive patients hospitalized for acute exacerbation of COPD, between October 1996 and May 1997. MEASUREMENTS AND RESULTS: Clinical, spirometric, and gasometric variables were evaluated at the time of inclusion in the study. Socioeconomic characteristics, comorbidity, dyspnea, functional status, depression, and quality of life were analyzed. Mortality at 180 days, 1 year, and 2 years was 13.4%, 22%, and 35.6%, respectively. Sixty-four patients (47.4%) were dead at the end of the study (median follow-up duration, 838 days). Greater mortality was observed in the bivariate analysis among the oldest patients (p < 0.0001), women (p < 0.01), and unmarried patients (p < 0.002). Hospital admission during the previous year (p < 0.001), functional dependence (Katz index) [p < 0.0004], greater comorbidity (Charlson index) [p < 0.0006], depression (Yesavage Scale) [p < 0.00001]), quality of life (St. George's Respiratory Questionnaire [SGRQ]) [p < 0.01], and PCO(2) at discharge (p < 0.03) were also among the significant predictors of mortality. In the multivariate analysis, the activity SGRQ subscale (p < 0.001; odds ratio [OR], 2.62; confidence interval [CI], 1.43 to 4.78), comorbidity (p < 0.005; OR, 2.2; CI, 1.26 to 3.84), depression (p < 0.004; OR, 3.6; CI, 1.5 to 8.65), hospital readmission (p < 0.03; OR, 1.85; CI, 1.26 to 3.84), and marital status (p < 0.0002; OR, 3.12; CI, 1.73 to 5.63) were independent predictors of mortality. CONCLUSIONS: Quality of life, marital status, depressive symptoms, comorbidity, and prior hospital admission provide relevant information of prognosis in this group of COPD patients.

Maximum FIO2 in minimum time depending on the kind of resuscitation bag and oxygen flow.

OBJECTIVE: To analyze what FIO2 can be reached, and how long it takes using the different autoinflated resuscitation bags and increasing oxygen flows. DESIGN: Experimental analysis on the effect of three different models of autoinflated resuscitation bag and increasing oxygen flows in the final FIO2, and time spent to reach it. SETTING: Laboratory, with a gas analyzer and a lung simulator to measure inspired FIO2. INTERVENTIONS: Simulated cardiopulmonary resuscitation. Three different autoinflated resuscitation bags were studied; A, the classic one with oxygen delivery directly into the bag, without reservoir, B, a new one without the reservoir device; and C, a new one with the reservoir device properly implemented. Increasing oxygen flows were administered until FIO2 stabilized. RESULTS: With model A the maximum FIO2 reached was 0.73 in 70 s using a 20 l/min oxygen flow. With model B the maximum FIO2 reached was 0.65 in 90 s using a 20 l/min oxygen flow. The best FIO2 (0.99) was reached using model C in 55 s with 12 l/min oxygen flow. In the three models a high correlation between oxygen flow and FIO2 was found (r>0.8). CONCLUSIONS: It is mandatory to use model C resuscitation autoinflated bag with 12 l/min of oxygen flow during the resuscitation maneuvers. Using another autoinflated bag model, maximum oxygen flows (i.e., 20 l/min) are needed. The resuscitation autoinflated bags showed less effectiveness when they were not properly assembled.

[Impact of the economic crisis on the activity of a clinical research ethics committee]. / Impacto de la crisis económica en la actividad de un comité ético de investigación clínica.

PURPOSE: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). METHOD: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). RESULTS: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. CONCLUSIONS: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

Objetivos: Analizar el impacto de la crisis económico-social en volumen y financiación de los ensayos clínicos (EC) y estudios observacionales (EO) a partir de la actividad de un Comité Ético de Investigación Clínica (CEIC). Método: Se revisaron las memorias del CEIC desde 2003 hasta 2012. Se analizó la financiación de los EC y los EO clasificándolos en cuatro grupos: 1) promovidos por la industria farmacéutica, 2) por sociedades científicas con soporte de la industria, 3) por sociedades apoyadas por las administraciones públicas y 4) sin financiación. Se compararon dos períodos: precrisis (2003- 2007) y crisis (2008-2012). Resultados: Se evaluaron 744 protocolos: un 71% del grupo 1, un 9% del grupo 2, un 3% del grupo 3 y un 17% carecía de financiación. En cuanto a los EO, un 40%, un 5,4%, un 8,6% y un 46% correspondían a los grupos 1, 2, 3 y 4 respectivamente. Analizando periodo crisis versus precrisis, se observaron diferencias estadísticamente significativas en el número de los EC de fase 2 y fase 3 que disminuyeron y en los EO que aumentaron. En el periodo crisis respecto al precrisis, el Grupo 4 aumentó de manera estadísticamente significativa. Conclusiones: La evolución del número total de estudios evaluados por el CEIC tiende a mantenerse e incluso incrementarse en el tiempo. El CEIC mantiene su actividad e incluso la incrementa, a expensas de EO con y sin financiación.

Estandarización ortográfica. Respuesta / Ortographic standarization. Answer

No disponible

Participación ciudadana en los comités éticos institucionales de investigación clínica y asistenciales de Cataluña / Participation of civilians in Catalonian clinical research and health care institutional ethical review committees / Participação dos cidadãos na pesquisa clínica institucional das comissões éticas e cuidado na Catalunha

Resumen: Objetivo: Conocer el nivel de participación de pacientes, usuarios y ciudadanos en los comités de ética de la investigación (CEI) y los comités de ética asistencial (CEA) acreditados en Cataluña. Material y métodos: Estudio descriptivo transversal en una muestra oportunista de 30 CEI y CEA. Se administró un cuestionario dirigido a los presidentes y al representante de los usuarios o ciudadanos (miembro lego). Para la interpretación de los resultados se analizó medias y desviación estándar. Las respuestas a las preguntas de texto abierto se analizaron mediante un análisis cualitativo del contenido. Resultados: Del total de los 30 comités de ética (CEI y CEA) contactados, 12 (40%) aceptaron participar. En total se realizaron 15 entrevistas (9 miembros de CEI y 6 miembros de CEA): 8 presenciales, 4 telefónicamente y 3 contestadas por correo electrónico. Resultados de los CEI: del total de 7 CEI entrevistados, 2 tenían representación ciudadana en su comité. El perfil correspondía a una mujer, de profesión administrativa y a un hombre de profesión auditor contable, ambos de más de 50 años. Resultados de los CEA: de los 5 CEA que participaron, 2 declararon tener representación de la ciudanía. El perfil correspondía a una mujer, de profesión administrativa y a un hombre de profesión profesor, ambos de más de 50 años. Discusión: Actualmente hay poca representación de la ciudadanía/pacientes en los comités éticos institucionales. Constituye un tema actual de debate la necesidad de incorporar el punto de vista del ciudadano/paciente, habiendo, sin embargo, un desconocimiento sobre el perfil más idóneo y en discusión su representatividad.

Abstract: Aim: To know the level of participation of patients, users and civilians in scientific ethical review committees (SERC) and health care ethical review committees (HCERC) accredited in Catalonian. Materials and methods: Descriptive transversal study using an opportunistic sample of 30 SERC and HCERC. A questionnaire was filled out addressed to presidents and consumer or civilian (lay member) representatives. For the interpretation of results means and standard deviations were analyzed. Answers to open texts questions were analyzed using qualitative content analysis. Results: 12 committees (40%) accepted to participate; 15 interviews were carried out (9 SERC members and 6 HCERC members): 8 person to person, 4 by phone and 3 by email. SERC Results: Of 7 SERC interviewed, 2 have a civilian representative in the committee. The profile was a woman of administrative profession and an auditor accountant man, both older than 50 years. HCERC Results: Of 5 HCERC participating, 2 declared having a civilian representative. The profile was a woman of administrative profession and a man teacher, both older than 50 years. Discussion: Currently, there is low civilian/patient representation in institutional ethical review committees. Today, the need to incorporate the point of view of the civilian/patient is a debatable issue, being unknown the suitable profile and their representativeness is under discussion.

Resumo: Objetivo: Conhecer o nível de participação de pacientes, usuários e cidadãos em comitês de ética de pesquisa (CEI) e as comissões de ética de cuidados de saúde (CEA) acreditados na Catalunha. Material e métodos: Estudo descritivo, transversal em uma amostra oportunista de 30 CEI e CEA. Um questionário dirigido aos presidentes e representante dos usuários ou cidadãos (membro de leigo) foi administrado. Para a interpretação dos resultados foi feita uma análise que incluiu as médias e o desvio-padrão. Analisaram-se as respostas às perguntas do texto aberto com uma análise qualitativa do conteúdo. Resultados: Do total dos 30 comitês de ética (CEI e CEA) contatados, 12 (40%) concordaram em participar. No total foram realizadas 15 entrevistas (9 membros do CEI e 6 membros da CEA). De todas as entrevistas realizadas, 8 foram presenciais, 4 foram realizadas por telefone e 3 foram respondidas por e-mail. Resultados da CEI: do total de 7 entrevistados da CEI, 2 tinham representação cidadã na sua Comissão. O perfil correspondia a uma mulher, de carreira administrativa e a um home de profissão auditor contábil, ambos com mais de 50 anos. Resultados da CEA: dos 5 CEA que participaram, 2 declararam ter representação cidadã. O perfil correspondente era de uma mulher, de carreira administrativa e a um homem professor, ambos com mais de 50 anos. Discussão: Atualmente há pouca representação dos cidadãos/pacientes em comitês de ética institucionais. A necessidade de incorporar o ponto de vista do cidadão/paciente constitui um tema atual de discussão, no entanto, falta conhecimento sobre o perfil mais adequado e discussão sua representatividade.