The Experience of Spanish Prison Nurses with the HIV Pandemic.

INTRODUCTION: This study discusses the experiences of nurses in Spanish prisons during the HIV/AIDS pandemic, emphasizing administrative changes and adaptive measures, such as the creation of the Subdirectorate General of Penitentiary Health. OBJECTIVE: We describe the experiences of nurses in Spanish penitentiary centers in the face of the HIV/AIDS. MATERIALS AND METHODS: The interpretative and phenomenological approach explored experiences between 1981 and 2023 through focus groups and convenience sampling. Participants were recruited through telephone calls and telematic meetings using Microsoft Teams. Four key themes were identified: the stigmatization of inmates, changes in nursing, the importance of training and resources, and equal treatment between genders. RESULTS: The nursing vision focused on gathering information, providing comprehensive patient support, and sharing personal experiences. DISCUSSION: This research provides a historical perspective on the adaptation of prison nursing to the pandemic, highlighting coping processes and suggesting future lines of research on the experiences of inmates, prison guards, and surveillance officers. CONCLUSIONS: We highlight the low media visibility of the pandemic in prisons, underlining the importance of understanding and valuing the nursing experience in prison settings during health crises.

Normativa frente a la pandemia covid-19 en las prisiones españolas / Regulations against the covid-19 pandemic in spanish prisons

La pandemia por el SARS-COVID-2 ha supuesto un extraordinario desafío para las prisiones. A la indudable necesidad de tomar medidas firmes para evitar la entrada y propagación del virus en ellas, se unía la necesidad de que esas medidas respetaran los derechos de los reclusos y no constituyeran forma alguna de tratoinhumano o degradante. Las autoridades penitenciarias españolas han publicado una extensa normativa queha cambiado la vida en las prisiones durante el tiempo de pandemia. Hemos revisado el contenido de esanormativa, cuyas líneas maestras han sido: no discriminación y garantías de trato equivalente a la poblacióngeneral; coordinación con las autoridades sanitarias; interrupción o disminución de la circulación del virusdesde y hacia las prisiones; potenciación de alternativas al cumplimiento de condenas en régimen cerrado;medidas de restricción de la movilidad dentro de las prisiones y medidas de minimización de riesgos paralos trabajadores. En su gran mayoría, las medidas adoptadas han respetado los derechos de los reclusos. Lasmedidas de cuarentenas indiscriminadas han podido vulnerar esos derechos y además eran factibles medidasalternativas. La vacunación masiva de los reclusos tiene indicaciones de Salud Pública, constituye un imperativo ético en este grupo de personas vulnerables y debería ser implementada con prontitud.

The pandemic caused by SARS-COVID-2 has supposed an extraordinary challenge for prisons. There isan unavoidable need to take action to stop the entry and spread of the virus, however, the measures mustrespect prisoners’ rights and must not constitute any kind of inhuman or degrading treatment. Spanishprison authorities have published and extensive normative that has transformed life in prisons during thepandemic. We have reviewed the content of these norms, which’s main treads are: no discrimination andthe guarantee of an equivalent treatment than that to the regular population; coordination of medicalauthorities; interruption or diminution of the spread of the virus from or towards prisons; the strengthening of alternatives to closed regime sentences; mobility restriction methods inside prisons, and measuresto minimise the risks employees are exposed to. In general, the measures have respected prisoners’ rights.However, indefinite quarantine practices have likely violated them, being that there were other alternative measures. Ultimately, the extensive vaccination of prisoners has public health implications, constitutesan ethical imperative towards this group of vulnerable people and should be implemented promptly.

[Knowledge of the Assistance Bioethics Committee (ABC) between the general hospital health professionals]. / Conocimiento del Comité de Ética Asistencial (CEA) entre profesionales sanitarios de un hospital general.

To show hospital health professionals' knowledge on ABC. Observational, descriptive, transversal and analytical research using questionnaires designed ad hoc. Comparative statistical analysis applying Ji-square by Pearson and Fisher tests. Binary logistic regression model to determine the odd ratios (O.R) having education level and sex as independent variables. A 4% accuracy was accepted, as well as a confidence Interval of 95% and a p value inferior to 0.05. The data was processed by IBM SPSS Statistics v.20 software. Required sample of 351 professionals (108 doctors and other related graduate; 144 nurses and 99 clinical assistants (TCAE)). 276 participants (78,6%; IC95%: 74,0-82,2); of which 84 doctors (77,8%; IC95%: 68,8-85,2); 120 nurses (83,3%; IC95%: 76,2-89,0) y 71 TCAE (71,7%; IC95%: 61,7-80,3), predominantly women (194, 70,3%). 228 (82,6%) were aware of the existence of ABC. Both doctors and nurses had more knowledge of ABC than clinical assistants (p 0,0001 for both), however there was not significative difference between doctors and nurses (p=0,836; OR:0,901; IC95%: 0,334-2,228). 124 (45,1%) knew the functions of ABC, with doctors displaying more knownledge than both nurses and clinical assistants (p=0,002 and p 0,0001 respectively) and nurses showing more familiarity than clinical assistants (p=0,008). 129(47,6%) communicated ethical conflicts, showing no significative difference between doctors and nurses (p=0,119). However, clinical assistants displayed different behabiour than the other two groups in this regard (p 0,0001 and p=0,001 respectively). Of all, 47 (22,4%) communicated they had ethical conflicts regarding the beginning and end of life. The knowledge on the existence of the ABC is high, however there is poor knowledge around its functions. Among health professionals, doctors and nurses know him better than TCAE. Matters related with the beginning and end of life cause most of ethical conflicts.

Conocimiento del Comité de Ética Asistencial (CEA) entre profesionales sanitarios de un hospital general / Knowledge of the Assistance Bioethics Committee (ABC) between the general hospital health professionals

Mostrar el conocimiento del CEA entre los profesionales sanitarios de un hospital. Estudio observacional, descriptivo, transversal y analítico Se cumplimentó un cuestionario diseñado ad hoc. Análisis comparativo mediante el test de Ji-cuadrado de Pearson y test de Fisher. Modelos de regresión logística binaria para determinar los odd ratios (O.R), siendo variables independientes titulación y sexo. Se aceptaron una precisión del 4%, intervalo de confianza del 95% y p valor inferior a 0,05. Se utilizó el programa IBM SPSS Statistics V.20. Muestra requerida: 351 profesionales (108 médicos y otros licenciados; 144 enfermeros y 99 auxiliares de clínica (TCAE)). Contestaron 276 (78,6%; IC95%: 74,0-82,2); 84 médicos (77,8%; IC95%: 68,8-85,2); 120 enfermeros (83,3%; IC95%: 76,2-89,0) y 71 TCAE (71,7%; IC95%: 61,7-80,3), predominantemente mujeres (194, 70,3%). 28 (82,6%) conocían la existencia del CEA, más los médicos y enfermeros que auxilia-res (p < 0,0001 en ambos), pero sin diferencia entre médicos y enfermeros (p = 0,836; OR:0,901; IC95%: 0,334-2,228). 124 (45,1%) conocían sus funciones, más médicos que enfermeros y auxiliares (p = 0,002 y p < 0,0001) y más enfermeros que TCAE (p = 0,008). 129(47,6%) referían conflictos éticos, sin diferencias entre médicos y enfermeros (p = 0,119) pero sí entre estos y los TCAE (p < 0,0001 y p = 0,001). De todos, 47 (22,4%) refirieron haber tenido conflictos éticos relacionados con el inicio y final de la vida. El conocimiento de la existencia del CEA es elevado, pero pobre el de sus funciones. Médicos y enfermeros lo conocen mejor que TCAE. El inicio y el final de la vida son las situaciones que más conflictos éticos plantean

To show hospital health professionals' knowledge on ABC. Observational, descriptive, transversal and analytical research using questionnaires designed ad hoc. Comparative statistical analysis applying Ji-square by Pearson and Fisher tests. Binary logistic regression model to determine the odd ratios (O.R) having education level and sex as independent variables. A 4% accuracy was accepted, as well as a confidence Interval of 95% and a p value inferior to 0.05. The data was processed by IBM SPSS Statis-tics V.20 software. Required sample of 351 professionals (108 doctors and other related graduate; 144 nurses and 99 clinical assistants (TCAE)). 276 participants (78,6%; IC95%: 74,0-82,2); of which 84 doctors (77,8%; IC95%: 68,8-85,2); 120 nurses (83,3%; IC95%: 76,2-89,0) y 71 TCAE (71,7%; IC95%: 61,7-80,3), predominantly women (194, 70,3%). 228 (82,6%) were aware of the existence of ABC. Both doctors and nurses had more knowledge of ABC than clinical assistants (p < 0,0001 for both), however there was not significative difference between doctors and nurses (p = 0,836; OR:0,901; IC95%: 0,334-2,228). 124 (45,1%) knew the functions of ABC, with doctors displaying more knownledge than both nurses and clinical assistants (p = 0,002 and p < 0,0001 respectively) and nurses showing more familiarity than clinical assistants (p = 0,008). 129(47,6%) communicated ethical conflicts, showing no significative difference bet-ween doctors and nurses (p = 0,119). However, clinical assistants displayed different behabiour than the other two groups in this regard (p < 0,0001 and p = 0,001 respectively). Of all, 47 (22,4%) communicated they had ethical conflicts regarding the beginning and end of life. The knowledge on the existence of the ABC is high, however there is poor knowledge around its functions. Among health professionals, doctors and nurses know him better than TCAE. Matters related with the beginning and end of life cause most of ethical conflicts

Sociodemographic, Clinical, and Therapeutic Aspects of Penitentiary Psychiatric Consultation: Toward Integration Into the General Mental Health Services.

The characteristics of mental disorders, as well as deficiencies in their treatment, must be properly defined. This was a prospective, longitudinal, observational study, in which all men referred to a penitentiary psychiatric consultation of three penitentiary centers in Spain were invited to participate. Those who consented to participation (1328) were interviewed at the baseline timepoint and at intervals for up to 3 years. The presence of mental disorders was high: 68.2% had a cluster B personality disorder, 14% had an affective and/or anxiety disorders, 13% had schizophrenia, and over 80% had a dual disorder. Polypharmacy was the norm. Moreover, the health care received in prison did not match that provided in the community in terms of quantity and quality. These results should help to facilitate the design of mental healthcare provision for prisoners, focusing on both the most frequent patient profiles and equality of care.

Información clínica, consentimiento informado y deontología médica. Una relación reciente / Clinical information, informed consent and medical deontology. A recent relationship

El derecho a la información clínica y el consentimiento informado como expresión práctica del principio de autonomía, son conquistas legales en España de finales del siglo XX que se han trasladado a la normativa deontológica médica. Se estudia el ritmo de ese traslado. Revisión histórica de los diferentes códigos de deontología médica desde la Guerra Civil, buscando la presencia de estas ideas en ella. Hasta el código de 1979 la idea de información clínica no aparece en la normativa deontológica vigente y el consentimiento lo hace en casos muy restringidos. A partir de esa fecha su aparición es progresiva en los sucesivos códigos. Actualmente ambas ideas están completamente desarrolladas en la normativa deontológica española. La Deontología médica ha asumido como suyas las ideas de información al paciente y consentimiento in-formado. Este ha sido un proceso largo en el tiempo que ha cambiado en buena medida la orientación deontológica para las relaciones médico-enfermo. En estos aspectos, la Deontología médica pasa, de hacer hincapié en la prudencia del médico, a subrayar el deber de informar y de dar amplio espacio a las decisiones del paciente, al que reconoce como un agente moral autónomo y reflexivo, capaz de tomar sus propias decisiones sobre su salud

In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, see-king the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient’s decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health

[Clinical information, informed consent and medical deontology. A recent relationship]. / Información clínica, consentimiento informado y deontología médica. Una relación reciente.

In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, seeking the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient's decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health.

El consentimiento informado: algo no resuelto en el ámbito penitenciario / Informed consent: something unresolved in the penitentiary setting

Introducción: El ejercicio del Consentimiento Informado (CI) en el ámbito penitenciario se contradice con lo dispuesto para la población general en nuestro ordenamiento legal. Material y Método: Revisión de la normativa legal y doctrina constitucional sobre CI. Revisión de las resoluciones judiciales cuando un preso se niega a un tratamiento médico. Resultados: Normativa sobre CI (Ley 41/2002 y Convenio de Oviedo): Excepto en imposibilidad de recabar CI y daños a terceros, cualquier persona competente y capaz puede decidir sobre su vida y salud, y esa decisión debe ser respetada. Ley de investigación biomédica: no mencionan las prisiones. Normativa penitenciaria (Ley 1/1979, orgánica, general penitenciaria, Reglamento Penitenciario): la Administración debe velar por la vida y salud de los presos. Doctrina constitucional: Sentencias del Tribunal Constitucional (STC) 120/1990; 137/1990 y 11/1991: se ampara la legitimidad constitucional de la alimentación forzada a un huelguista de hambre equiparándola a un tratamiento médico; esto se justifica por la necesidad de preservar el bien superior de la vida humana. STC 37/2011: el CI es inherente al derecho fundamental a la integridad física. Resoluciones judiciales (juzgados de Instrucción y de Vigilancia Penitenciaria): autorizan el tratamiento médico forzoso de un preso cuando, a criterio médico, su vida o su salud corran peligro. Conclusiones: Los presos ven limitado el ejercicio del derecho al CI en casos extremos en que su vida o salud están amenazadas. Esta práctica es un mandato judicial que atenta contra el derecho fundamental constitucional a la integridad física y contra la legislación común sobre CI

Introduction: The exercise of Informed Consent within the penitentiary environment contradicts the ordinary exercise of the same towards the rest of the population. Methodology: review of legal regulations and constitutional doctrine on IC. Review of the judicial outcomes when a prisoner refuses medical treatment. Results: Normative on IC (Ley 41/2002 y Convenio de Oviedo, Spanish legal framework): with the exception of cases in which IC cannot be taken or under the risk of causong damage to third parties, competent and capable persons can decide over their life and health, and such decisions need to be respected. Biomedical Research Law: no mention of prisons. Penitentiary normative on IC (Ley 1/1979, orgánica, general penitenciaria, Reglamento Penitenciario, Spanish legal framework): the Administration must veil over prisoners' life and health. Constitutional Doctrine: Constitutional Court Sentence (STC) 120/1990; 137/1990 and 11/1991 (Spanish legal framework): constitutional legitimacy to apply forcible feeding on a hunger striker is provisioned as it is compared to medical treatment; justified due to the need to preserve the higher good of human life. STC 37/2011: IC is inherent to the fundamental right to physical integrity. Judicial resolutions: authorisation of forcible medical treatment over a prisoner if, under medical criteria, his life or health are at stake. Conclusions: limitations over prisoners' rights concerning IC are applied in extreme cases in which his/her life or health are threatened. This practice unveils judicial mandates infringing upon the fundamental and constitutional right to physical integrity, and upon the common legislation on IC

[Informed Consent: Something Unresolved in the Penitentiary Setting]. / El Consentimiento Informado: Algo no Resuelto en el Ámbito Penitenciario.

INTRODUCTION: The exercise of Informed Consent within the penitentiary environment contradicts the ordinary exercise of the same towards the rest of the population. METHODOLOGY: review of legal regulations and constitutional doctrine on IC. Review of the judicial outcomes when a prisoner refuses medical treatment. RESULTS: Normative on IC (Ley 41/2002 y Convenio de Oviedo, Spanish legal framework): with the exception of cases in which IC cannot be taken or under the risk of causong damage to third parties, competent and capable persons can decide over their life and health, and such decisions need to be respected. Biomedical Research Law: no mention of prisons. Penitentiary normative on IC (Ley 1/1979, orgánica, general penitenciaria, Reglamento Penitenciario, Spanish legal framework): the Administration must veil over prisoners' life and health. Constitutional Doctrine: Constitutional Court Sentence (STC) 120/1990; 137/1990 and 11/1991 (Spanish legal framework): constitutional legitimacy to apply forcible feeding on a hunger striker is provisioned as it is compared to medical treatment; justified due to the need to preserve the higher good of human life. STC 37/2011: IC is inherent to the fundamental right to physical integrity. Judicial resolutions: authorisation of forcible medical treatment over a prisoner if, under medical criteria, his life or health are at stake. CONCLUSIONS: limitations over prisoners' rights concerning IC are applied in extreme cases in which his/her life or health are threatened. This practice unveils judicial mandates infringing upon the fundamental and constitutional right to physical integrity, and upon the common legislation on IC.

[Descriptive Study of the Activities Performed By the Provincial Medical Deontology Commissions]. / Estudio Descriptivo de la Actividad de Las Comisiones de Deontología Provinciales Hoy en España.

AIM: to describe the expedient's features those settle the medical ethics commissions of the provincial colleges (PMEC). MATERIAL AND METHODOLOGY: descriptive study, retrospective from the typology of the received claims to the PMEC between 01-06-2013 and 31-05-2014. The colleges were selected by simple stratified random sample. Variables related with the origin of the claim, chapter of the Medical Ethics Code affected, resolution timescales, judgement and others; were gathered. Descriptive analysis of the variables, expressing with medians the quantitative variables and their corresponding interquartile ranges; and with absolute and relative frequencies the qualitative ones. A bivariate analysis, through Kruskal-Wallis and Chi-square tests. RESULTS: 10 provincial colleges participated (47.652 members, 20.2% from the Spanish total) that communicated 120 claims. Overall impact: 2.5 claims %0 members/year. The denouncers are mainly patients (80%). The family medicine is the most affected specialty (19.2% of the claims), the quality of the medical attention the most affected chapter of the CD (60% of the claims). The global resolution timescale was 115.5 days (55-187). The PMEC judged ethical failure in 17 cases (14.2), 10 of them within the private sector. 8 (6.7%) were pending on the date 01-03-2015. 8 cases (6.7%) ended in disciplinary file by the management board, one in verbal amonestation and one was pendent of resolution. CONCLUSIONS: the incidence of the medical ethics claims is low, as well as the proportion of disciplinary files. Too many discrepancies exist between the judgements of the PMEC and the college's management boards.

Estudio descriptivo de la actividad de las Comisiones de Deontología Provinciales hoy en España / Descriptive study of the activities performed by the provincial medical deontology commissions

Objetivo: Describir las características de los expedientes que dirimen las comisiones de deontología de los colegios de médicos provinciales (CdDP). Material y método: Estudio descriptivo, retrospectivo de la tipología de las reclamaciones llegadas a las CdDP entre 01-06-2013 y 31-05-2014. Selección de los colegios mediante muestreo aleatorio estratificado simple. Se recogieron variables relacionadas con el origen de la queja, capítulo del Código de Deontología (CD) afectado, plazos de resolución, dictamen y otras. Análisis descriptivo de las variables, expresando con medianas las cuantitativas con sus correspondientes rangos intercuartílicos (IQR, p25-p75) y con frecuencias absolutas y relativas las cualitativas. Análisis bivariante, mediante las pruebas de Kruskal-Wallis y test de Ji-Cuadrado. Resultados: Participaron 10 colegios (47.625 colegiados; 20,2% de todos los de España) que comunicaron 120 reclamaciones. Incidencia global: 2,5 reclamaciones ‰ colegiados/año. Principalmente denuncian los pacientes (96 casos, 80%), siendo medicina de familia la especialidad más afectada (19,2% de las reclamaciones), la calidad de la atención médica es el capítulo del CD más afectado (60% de las reclamaciones). El plazo de resolución global fue de 111,5 días (55-187). La CdDP dictaminó falta deontológica en 17 casos (14,2%), 10 de ellos en ejercicio privado. 8 (6,7%) estaban pendientes de resolución con fecha 01-03-2015. 8 casos (6,7%) acabaron en expediente disciplinario por la Junta Directiva, uno en amonestación verbal y otro estaba pendiente de resolución. Conclusiones: La incidencia de quejas deontológicas es baja, igual que la proporción de faltas. Existen demasiadas discrepancias entre los dictámenes de las CdDM y las Juntas Directivas colegiales

Aim: to describe the expedient’s features those settle the medical ethics commissions of the provincial colleges (PMEC). Material and methodology: descriptive study, retrospective from the typology of the received claims to the PMEC between 01-06-2013 and 31-05-2014. The colleges were selected by simple stratified random sample. Variables related with the origin of the claim, chapter of the Medical Ethics Code affected, resolution timescales, judgement and others; were gathered. Descriptive analysis of the variables, expressing with medians the quantitative variables and their corresponding interquartile ranges; and with absolute and relative frequencies the qualitative ones. A bivariate analysis, through Kruskal-Wallis and Chisquare tests. Results: 10 provincial colleges participated (47.652 members, 20.2% from the Spanish total) that communicated 120 claims. Overall impact: 2.5 claims %0 members/year. The denouncers are mainly patients (80%). The family medicine is the most affected specialty (19.2% of the claims), the quality of the medical attention the most affected chapter of the CD (60% of the claims). The global resolution timescale was 115.5 days (55-187). The PMEC judged ethical failure in 17 cases (14.2), 10 of them within the private sector. 8 (6.7%) were pending on the date 01-03-2015. 8 cases (6.7%) ended in disciplinary file by the management board, one in verbal amonestation and one was pendent of resolution. Conclusions: the incidence of the medical ethics claims is low, as well as the proportion of disciplinary files. Too many discrepancies exist between the judgements of the PMEC and the college’s management boards

Directly observed therapy for chronic hepatitis C: A randomized clinical trial in the prison setting / Tratamiento directamente observado de la hepatitis C crónica: un ensayo clínico aleatorizado en el ámbito penitenciario

BACKGROUND: The diagnosis and treatment of chronic hepatitis C are major concerns in prisons. OBJECTIVES: The aim of this randomized clinical trial was to determine the extent to which directly observed therapy (DOT) improved the efficacy of the standard treatment for chronic hepatitis C in the prison setting. PATIENTS AND METHODS: A randomized clinical trial was carried out to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C (based on pegylated interferon alpha-2a and ribavirin). RESULTS: A total of 252 inmates were randomized, of which 244 were analyzed: 109 in the DOT group and 135 in the non-DOT group. The mean age was 35.88 years (SD 6.54), 94.3% were men, 72.1% reported intravenous drug use, 21.3% were HIV co-infected, and 55.3% had genotype 1 or 4. The patients received the study treatment for a median time of 33.9 weeks in the overall sample. Sustained virological response was achieved in 60.6% (95% CI, 51.17-69.22) of the DOT group and in 65.9% (95% CI, 57.59-73.38) of the standard therapy group (risk ratio = 0.92; 95% CI, 0.76-1.12). The mean proportion of patients continuing the treatment was 83% (SD = 31). Adverse events were reported in 93.4% of the patients, and serious adverse events were reported in 8.2%, with no significant differences between groups. CONCLUSIONS: Sustained virological response was remarkably high, although there were no differences between groups, probably due to high treatment adherence

ANTECEDENTES: El diagnóstico y tratamiento de la hepatitis C crónica son una preocupación importante en los centros penitenciarios. OBJETIVOS: El propósito de este ensayo clínico aleatorizado fue determinar hasta qué punto el tratamiento directamente observado (TDO) mejoraba la eficacia del tratamiento estándar para la hepatitis C crónica en el ámbito penitenciario. PACIENTES Y MÉTODOS: Ensayo clínico aleatorizado para evaluar la eficacia del TDO comparado con el tratamiento auto-administrado en internos que reciben régimen estándar para la hepatitis C crónica (interferón pegilado alfa-2a y ribavirina). RESULTADOS: Se aleatorizaron un total de 252 sujetos, de los cuales se analizaron 244: 109 el grupo TDO y 135 en el grupo no-TDO. La media de edad fue 35,88 (DE 6,54), 94,3% eran hombres,72,1% eran usuarios de drogas intravenosas, 21,3% co-infectados con HIV y 55,3% tenían genotipo1 o 4. En la muestra global, los pacientes recibieron el tratamiento del estudio durante una mediana de tiempo de 33,9 semanas. La respuesta virológica sostenida fue llamativamente elevada, aunque no hubo diferencias entre grupos, probablemente debido a la elevada adherencia al tratamiento en las dos ramas (AU)

Directly observed therapy for chronic hepatitis C: a randomized clinical trial in the prison setting.

BACKGROUND: The diagnosis and treatment of chronic hepatitis C are major concerns in prisons. OBJECTIVES: The aim of this randomized clinical trial was to determine the extent to which directly observed therapy (DOT) improved the efficacy of the standard treatment for chronic hepatitis C in the prison setting. PATIENTS AND METHODS: A randomized clinical trial was carried out to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C (based on pegylated interferon alpha-2a and ribavirin). RESULTS: A total of 252 inmates were randomized, of which 244 were analyzed: 109 in the DOT group and 135 in the non-DOT group. The mean age was 35.88 years (SD 6.54), 94.3% were men, 72.1% reported intravenous drug use, 21.3% were HIV co-infected, and 55.3% had genotype 1 or 4. The patients received the study treatment for a median time of 33.9 weeks in the overall sample. Sustained virological response was achieved in 60.6% (95% CI, 51.17-69.22) of the DOT group and in 65.9% (95% CI, 57.59-73.38) of the standard therapy group (risk ratio=0.92; 95% CI, 0.76-1.12). The mean proportion of patients continuing the treatment was 83% (SD=31). Adverse events were reported in 93.4% of the patients, and serious adverse events were reported in 8.2%, with no significant differences between groups. CONCLUSIONS: Sustained virological response was remarkably high, although there were no differences between groups, probably due to high treatment adherence.

[Clinical research and prisoners: coercion and grounds to participate]. / Investigación clínica y presos: coerción y motivos para participar.

AIM: To assess the coercion perceived, the quality of the information, and the reasons that lead prisoners to participate in clinical research. MATERIAL AND METHOD: Descriptive and multicenter study. Information was gathered on the social, demographic and penitentiary characteristics, perceived coercion, kind of information received and reasons that lead prisoners to take part in research. Both univariate and bivariate analyses were performed. Quantitative variables are expressed as mean or median, and qualitative ones as absolute numbers or percentages. Comparison between means is performed by a Student T-test, and between medians by a Mann-Whitney U-test. The research was approved by an accredited Ethical Research Committee. RESULTS: The sample comprises 110 prisoners from 11 different prisons, mean age 41.8 (40.4-43.2) years. Of these 105 were men and 8 non-Spanish. 83 prisoners (75.5%) opined they received high quality information about the clinical research; although, only 73 (66.4%) understood it completely. 104 (94.5%) felt no coercion and to 92.5% said they were guaranteed an anonymity. The reasons to be included in the research were: benefits for science (67.3%); benefit for future patients (65.5%); altruism (65.5%); possibility of improvement in the own illness (70%). Bivariate analyses showed no differences that depended on the length of the sentence or educational level. CONCLUSIONS: Spanish prisoners take part in clinical researches freely. The information provided on the research should be improved and be made more understandable. Altruism and benefits for the science are the principal reasons for participating in research.

[Causes and trends of mortality in a Spanish prison (1994-2009)]. / Causas y tendencia de la mortalidad en una prisión española (1994-2009).

BACKGROUND: There are a few mortality researches in prisons. To know this measure can to be important for take decisions of Public Health. The aim of the paper is to describe mortality and its trend in our prison. METHODS: This is a descriptive and retrospective study of the deaths between 01/01/1994 and 31/12/2009. Two periods of 8 years have been compared through exact test of Fisher in order to detect changes in causes of mortality. First of all, we made an indirect standardization of rates and compare mortality in our institution with other Spanish prisons. Through linear regression model we have settled in trends of mortality rates. RESULTS: Had 59 deaths, 58 in men with a median age 34.9 years old (28.7- 40.4). 64,4% were HIV+ . From 1994 to 2001 the main cause of mortality was VIH infection (48.6%) the second one was cardiovascular event (10.8%), while that between 2002 and 2009 this trend have change, cardiovascular event caused (31.8%) and VIH infection (22.07%) (p=0.026).The annual crude mortality rate decreased -0.485 deaths ‰ inmates/year (IC 95%: -0.864 to -0.107). Standardizing rates, we get 42 deaths expected for the wholly period, with Standarized Mortality Ratio of 1.407 (I.C. 95%: 1.071 to 1.816). CONCLUSIONS: The main cause of mortality has been no-HIV diseases, among these mainly cardiovascular events. The trend of mortality rate has been decreasing although we observe 40.7% plus of deaths than we would expect.

Causas y tendencia de la mortalidad en una prisión española (1994-2009) / Causes and trends of mortality in a Spanish prison (1994-2009)

Fundamento: El conocimiento de las causas de mortalidad puede ser una herramienta valiosa para procurar mejores cuidados de salud a las personas encarceladas. El objetivo del trabajo es describir la mortalidad y su tendencia en nuestro centro. Método: Estudio descriptivo de los fallecimientos ocurridos entre el 01/01/1994 y 31/12/2009. Se compararon mediante el test exacto de Fisher dos periodos de 8 años para valorar cambios en las causas de mortalidad. Previa estandarización indirecta de tasas, comparamos la mortalidad de nuestro centro con la del resto de las prisiones españolas. Mediante un modelo de regresión lineal establecimos la tendencia de las tasas de mortalidad. Resultados: Hubo 59 defunciones, 58 en hombres, con una mediana de edad de 34,9 años (28,7- 40,4). El 64,4% eran VIH+. Desde 1994 hasta 2001 la principal causa de mortalidad fue la infección VIH (48,6%) y la segunda los eventos cardiovasculares (10,8%), mientras que entre 2002 y 2009 los eventos cardiovasculares causaron un 31,8% y la infección VIH un 22,7% (p=0,026). Las tasas crudas de mortalidad anual tuvieron tendencia descendente a razón de 0,485 muertes internos/año (IC 95%: 0,864 a -0,107). Estandarizando tasas corresponderían 42 muertes esperadas en todo el período, con una Razón de Mortalidad Estandarizada de 1,407 (IC 95%: 1,071 a 1,816). Conclusiones: La principal causa de mortalidad fue la enfermedad no-VIH, fundamentalmente por eventos cardiovasculares. La tendencia de la tasa de mortalidad fue descendente, aunque observamos un 40,7% más de defunciones de las que cabría esperar (AU)

Background: There are a few mortality researches in prisons. To know this measure can to be important for take decisions of Public Health. The aim of the paper is to describe mortality and its trend in our prison. Methods: This is a descriptive and retrospective study of the deaths between 01/01/1994 and 31/12/2009. Two periods of 8 years have been compared through exact test of Fisher in order to detect changes in causes of mortality. First of all, we made an indirect standardization of rates and compare mortality in our institution with other Spanish prisons. Through linear regression model we have settled in trends of mortality rates. Results: Had 59 deaths, 58 in men with a median age 34.9 years old (28.7- 40.4). 64,4% were HIV+ . From 1994 to 2001 the main cause of mortality was VIH infection (48.6%) the second one was cardiovascular event (10.8%), while that between 2002 and 2009 this trend have change, cardiovascular event caused (31.8%) and VIH infection (22.07%) (p=0.026).The annual crude mortality rate decreased -0.485 deaths inmates/year (IC 95%: -0.864 to -0.107). Standardizing rates, we get 42 deaths expected for the wholly period, with Standarized Mortality Ratio of 1.407 (I.C. 95%: 1.071 to 1.816). Conclusions: The main cause of mortality has been no-HIV diseases, among these mainly cardiovascular events. The trend of mortality rate has been decreasing although we observe 40.7% plus of deaths than we would expect (AU)

[Prisoners as subjects of biomedical research]. / Los presos como sujetos de investigación biomédica.

The medical research with prisoners ever along the History until our age has attacked to physical integrity and prisoners' human rights. We have a perfect evidence about this kind of human rights violation if we have a look sixty years ago to Nazi's concentrations camps. Probably for this reason the international legislations restricts or ban this type of practices. There are, although, some arguments used for it, like the impossibility to decide something inside a context with lack of freedom, improper inducements, coercion and duress. The objective of our work is study if exist any important reason, inside a pure bioethical view, that support the prohibition of using prisoners as subjects in medical research, showing actual fettles of Spanish prisons.