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.

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.

[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.

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.

[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.

[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.

[Trends in mortality in a Spanish prison from 1994-2004]. / Tendencia de la tasa de mortalidad en una prisión Española (1994-2004).

BACKGROUND: [corrected] Few works have focused on studying mortaty in prisons. The objective here is to study the causes and incidences of mortality in a Spanish prison. METHODS: Descriptive study of the deaths in a prison between 01-01-1994 and 31-12-2004. The following variables were recorded: sex, date of death, HIV serology, number of CD4+ where relevant, and cause of death according to the following classification: death by HIV, by non-HIV disease, suicide, drug overdose and accidents. After indirect standardisation of incidence, we compared mortality in the Centre with the other Spanish prisons. We established mortaality rate tendencies by a linear regression model. RESULTS: 42 deaths, 41 men, 1 woman. Median age 33.10 years (27.72-36.12; IQR: 8.40). 30 (71.4%) HIV+, with a median of 177 CD4+ lymphocytes/microl. Twenty patients (45.24%) died from HIV, 15 (38.10%) from non-HIV diseases, 3 (7.14%) from suicide, 3 (7.14%) from drug overdose and 1 (2.38%) accidentally. Crude mortality rates corresponded to 12.605% per hundred of inmates/year in 1997 and 1.758%, inmates/year in 2003, with a decreasing trend of 0.976 deaths % per hundred, inmates/year (CI 95%: 0.399-1.552; p = 0.004). After standardising rates, we obtain 28.6 expected deaths daring the period, with an SMR of 1.4679. CONCLUSIONS: Although it follows a decreasing trend, the mortality rate obtained during the study period was higher than expected. The main cause of mortality was acquired immunodeficiency syndrome.

[Mutations of resistance of HIV-1 in previously untreated patients at penitentiary centers of the Autonomous Community of Valencia, Spain. REPRICOVA study]. / Mutaciones de resistencia de virus de la inmunodeficiencia humana tipo 1 en pacientes no tratados de los centros penitenciarios de la Comunidad Valenciana. Estudio REPRICOVA.

BACKGROUND: Our purpose was to determine the prevalence of mutations of resistance to nucleoside inhibitors of reverse transcriptase (NIRT) and protease inhibitors (PI) in the HIV-1 genotype of naïve infected subjects in the prisons of the Autonomous Community of Valencia, Spain. PATIENTS AND METHOD: Multicentric, descriptive, cross-sectional study of prevalence including a systematic stratified and randomised sampling by centres. Demographic, clinical, virological and immunological data were collected. The HIV gene of protease and transcriptase was studied in peripheral blood plasma samples by means of double PCR amplification and subsequent automatic sequence. Reference: wild strain HXB2. RESULTS: Plasma was obtained from 133 individuals (119 men and 14 women). 117 samples were selected and the rest did not have enough copies for transcription. With regard to NIRT, 7 samples (5.2% of total) showed some mutation of resistance: M41L, D67N, L210W and K219Q, all them secondary to and associated with resistance to zidovudine, abacavir as well as group B multinucleoside-resistance. With regard to PI, only one sample showed a primary mutation, M46I, which was associated with resistance to indinavir. Moreover, a further 41 samples were found to express some secondary mutation. CONCLUSIONS: In our series, there was a low number of primary mutations of resistance. These results allow us to exclude the systematic use of resistance tests before an initiation antiretroviral therapy.

[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.

[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.

[Primary HIV drug resistance in a prison population. REPRICOVA-2 Study]. / Resistencias primarias de VIH en una población penitenciaria. Estudio REPRICOVA-2.

INTRODUCTION: Currently, there are few reports on primary human immunodeficiency virus (HIV) drug resistance in the prison population. METHODS: This is a descriptive, one-day prevalence study to identify HIV drug-resistant mutations in chronically infected treatment-naïve prisoners. Systematic randomized sampling was performed and genotyping was done by automatic sequencing. RESULTS: A total of 90 patients were studied. Two samples were found to have nucleoside reverse transcriptase inhibitor (NRTI)-resistant mutations, four had non-nucleoside reverse transcriptase inhibitor (NNRTI)-resistant mutations and one had protease inhibitor (PI)-resistant mutations. CONCLUSIONS: There was a low rate of primary resistance in our series. Therefore, resistance testing is not required before prescribing initial antiretroviral therapy in these patients.