Obstructive sleep apnea and quality of life in elderly patients with a pacemaker.

OBJECTIVE: To evaluate quality of life in elderly patients with obstructive sleep apnea (OSA) who have a pacemaker. METHODS: This was a cross-sectional study involving elderly patients (≥ 60 years of age) with a pacemaker. The dependent variable was quality of life, as evaluated with the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Sociodemographic and clinical parameters, including anxiety and depression (Hospital Anxiety and Depression Scale score), as well as the presence of OSA (defined as an apnea-hypopnea index ≥ 15 events/h), were analyzed as independent variables. Patients with cognitive/neurological deficits or decompensated heart failure were excluded. RESULTS: We evaluated 72 patients, 17 (23.6%) of whom presented OSA. Of those 17 patients, 9 (52.9%) were male. The mean age was 72.3 ± 9.3 years. A diagnosis of OSA was not associated with gender (p = 0.132), age (p = 0.294), or body mass index (p = 0.790). There were no differences between the patients with OSA and those without, in terms of the SF-36 domain scores. Fourteen patients (19.4%) presented moderate or severe anxiety. Of those 14 patients, only 3 (21.4%) had OSA (p = 0.89 vs. no OSA). Twelve patients (16.6%) had moderate or severe depression. Of those 12 patients, only 2 (16.6%) had OSA (p = 0.73 vs. no OSA). CONCLUSIONS: In elderly patients with a pacemaker, OSA was not found to be associated with quality of life or with symptoms of anxiety or depression.

Obstructive sleep apnea and quality of life in elderly patients with a pacemaker / Apneia obstrutiva do sono e qualidade de vida em idosos portadores de marca-passo

ABSTRACT Objective: To evaluate quality of life in elderly patients with obstructive sleep apnea (OSA) who have a pacemaker. Methods: This was a cross-sectional study involving elderly patients (≥ 60 years of age) with a pacemaker. The dependent variable was quality of life, as evaluated with the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Sociodemographic and clinical parameters, including anxiety and depression (Hospital Anxiety and Depression Scale score), as well as the presence of OSA (defined as an apnea-hypopnea index ≥ 15 events/h), were analyzed as independent variables. Patients with cognitive/neurological deficits or decompensated heart failure were excluded. Results: We evaluated 72 patients, 17 (23.6%) of whom presented OSA. Of those 17 patients, 9 (52.9%) were male. The mean age was 72.3 ± 9.3 years. A diagnosis of OSA was not associated with gender (p = 0.132), age (p = 0.294), or body mass index (p = 0.790). There were no differences between the patients with OSA and those without, in terms of the SF-36 domain scores. Fourteen patients (19.4%) presented moderate or severe anxiety. Of those 14 patients, only 3 (21.4%) had OSA (p = 0.89 vs. no OSA). Twelve patients (16.6%) had moderate or severe depression. Of those 12 patients, only 2 (16.6%) had OSA (p = 0.73 vs. no OSA). Conclusions: In elderly patients with a pacemaker, OSA was not found to be associated with quality of life or with symptoms of anxiety or depression.

RESUMO Objetivo: Avaliar a qualidade de vida em idosos portadores de marca-passo e apneia obstrutiva do sono (AOS). Métodos: Estudo de corte transversal com idosos (idade ≥ 60 anos) portadores de marca-passo cardíaco. A variável dependente foi qualidade de vida, avaliada por meio do Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Dados sociodemográficos e clínicos foram analisados como variáveis independentes, entre os quais ansiedade e depressão (por meio da Hospital Anxiety and Depression Scale), assim como presença de AOS (definida como um índice de apneia-hipopneia ≥ 15 eventos/h). Pacientes com déficits cognitivos/neurológicos ou descompensação cardíaca foram excluídos. Resultados: A amostra foi composta por 72 pacientes, 17 dos quais (23,6%) apresentaram AOS - 9 homens (52,9%). A média de idade foi de 72,3 ± 9,3 anos. Não houve associações de presença de AOS com sexo (p = 0,132), idade (p = 0,294) e índice de massa corpórea (p = 0,790). Não foram observadas diferenças dos domínios do SF-36 entre os grupos com e sem AOS. Em relação à ansiedade, 14 pacientes (19,4%) apresentaram sintomas moderados ou graves, dos quais apenas 3 (21,4%) tinham AOS (p = 0,89 vs. sem AOS). No tocante à depressão, 12 pacientes (16,6%) apresentaram sintomas moderados ou graves, dos quais 2 (16,6%) tinham AOS (p = 0,73 vs. sem AOS). Conclusões: Nesta amostra em idosos portadores de marca-passo, a presença de AOS não foi associada a qualidade de vida e sintomas de ansiedade e depressão.

Fatores associados ao aumento da vulnerabilidade de participantes de pesquisa / Factors linked to the increased vulnerability of research subjects / Factores asociados al aumento de la vulnerabilidad de los participantes de la investigación

Resumo Trata-se de estudo de corte transversal cujo objetivo foi avaliar a prevalência de fatores associados ao aumento da vulnerabilidade de participantes de pesquisas. Foram entrevistados 116 pacientes e 18 médicos. Entre os pacientes, 15% eram analfabetos, 27% desconheciam o motivo do seu internamento e 45% não sabiam qual tratamento estavam recebendo. Do total da amostra, 43% procediam de zona rural e 70% haviam cursado, no máximo, ensino fundamental, fatores que tornam essa população especialmente vulnerável. Os percentuais de acerto em questões relacionadas à compreensão do termo de consentimento livre e esclarecido e de prescrição médica foram, respectivamente, 12% e 7%. Entre os médicos, 44% não conheciam todas as pesquisas realizadas na enfermaria pela qual eram responsáveis e 17% afirmaram que a permanência hospitalar de pacientes que participam de pesquisas é maior. É elevada a prevalência de fatores que aumentam a vulnerabilidade de participantes em pesquisas médicas.

Abstract A cross-sectional study was carried out that aimed to assess the prevalence of factors associated with the increased vulnerability of research subjects. A total of 116 patients and 18 doctors were interviewed. A proportion of 15% of patients were illiterate, 27% did not know the reason for their hospitalization and 45% did not know what treatment they were receiving. Of the total sample, 43% were from rural areas and 70% had at most an elementary level education, factors that make this population especially vulnerable. The percentage of correct answers on issues related to the understanding of free and informed consent and prescriptions were 12% and 7%, respectively. Among the doctors, 44% were not aware of all the research projects being carried out in the ward for which they were responsible, and 17% said that the hospital stays of patients participating in research were longer. The prevalence of factors that increased the vulnerability of subjects in medical research was high.

Se trata de un estudio de corte transversal que tuvo como objetivo evaluar la prevalencia de los factores asociados con el aumento de vulnerabilidad de los participantes de investigación. Fueron entrevistados 116 pacientes y 18 médicos. Entre los pacientes, el 15% eran analfabetos, el 27% desconocía el motivo de su hospitalización y el 45% no sabía qué tratamiento estaba recibiendo. Del total de la muestra, el 43% era de zonas rurales, y el 70% había cursado, como máximo, la educación básica, factores que tornan a esta población especialmente vulnerable. El porcentaje de respuestas correctas en cuestiones relacionadas con la comprensión del consentimiento libre e informado y de la prescripción médica fue de, respectivamente, 12% y 7%. Entre los médicos, el 44% no conocía todas las investigaciones realizadas en la enfermería de la cual eran responsables y el 17% afirmó que la permanencia hospitalaria de los pacientes que participan de investigaciones es mayor. Es elevada la prevalencia de factores que aumentan la vulnerabilidad de los participantes en investigaciones médicas.

Ética em pesquisas com seres humanos: do conhecimento à prática / Ethics in research with human beings: from knowledge to practice / Ética en investigaciones con seres humanos: desde el conocimiento a la práctica

FUNDAMENTO: No Brasil, a resolução 196/96 e suas complementares regulamentam a preservação dos direitos, do respeito e da dignidade dos seres humanos envolvidos em pesquisas. OBJETIVO: Analisar a adequação dos temas livres (TLs) apresentados durante o XVIII Congresso Pernambucano de Cardiologia à resolução 196/96. MÉTODOS: Estudo de Corte Transversal. Foram realizadas entrevistas com autores dos TLs apresentados. Os resumos dos trabalhos foram analisados no sentido de identificar a necessidade de prévia aprovação por um Comitê de Ética em Pesquisa (CEP). RESULTADOS: Foram apresentados 90 TLs. A fonte de dados mais utilizada foram prontuários médicos (86,8 por cento). Apenas 23,1 por cento dos TLs foram submetidos à avaliação por um CEP e em 15,4 por cento foi utilizado Termo de Consentimento Livre e Esclarecido (TCLE). Entre os autores cujos trabalhos não foram avaliados por um CEP, 65,6 por cento afirmaram que esta não era uma conduta necessária e 18,0 por cento deles desconheciam a necessidade de realizar tal avaliação. A autorização escrita do responsável pela instituição onde os TLs foram realizados não foi obtida em 56,6 por cento das pesquisas. A maioria (80,0 por cento) dos autores afirmou nunca ter lido a resolução 196/96. A proporção dos TLs submetidos a um CEP foi significativamente maior entre autores que haviam lido a resolução 196/96 (p = 0,005). O desenho dos TLs influenciou a não submissão dos trabalhos a um CEP (p < 0,001). A maioria dos TLs que foram autorizados pelo responsável da instituição onde foram realizados foi submetida a um CEP (p < 0,001). CONCLUSÃO: A maioria dos TLs apresentados não se adequou às regulamentações brasileiras em ética em pesquisa.

BACKGROUND: In Brazil, resolution 196/96 and its amendments regulate the preservation of rights, respect and dignity of human beings involved in research. OBJECTIVE: To analyze the adequacy of Free Communications (FC) presented during the XVIII Congresso Pernambucano de Cardiologia to resolution 196/96. METHODS: During a cross-sectional study, interviews were carried out with the authors of the FC presented at the Congress and the abstracts of the studies were assessed in order to identify the need for previous approval by a Research Ethics Committee (REC). RESULTS: A total of 90 FC were presented and, in most of them (86.8 percent), medical files were the most commonly used source of data. Only 23.1 percent of the FC were submitted to the assessment of a REC and 15.4 percent of them used a Free and Informed Consent Form (FICF). Among the authors whose studies were not assessed by a REC, 65.6 percent stated that this conduct was not necessary and 18 percent of them were unaware of the need to submit the study to such assessment. The written authorization given by the institution where the FC were carried out was not obtained in 56.6 percent of the studies. Most of the authors (80.0 percent) stated that they had never read Resolution 196/96. The proportion of FC submitted to a REC was significantly higher among authors that had read Resolution 196/96 (p = 0.005). The FC design influenced the non-submission of the studies to a REC (p < 0.001). Most of the FC that were authorized by the institution where they were carried out were submitted to a REC (p < 0.001). CONCLUSION: Most of the FC presented at the Congress did not follow the Brazilian regulations concerning the ethics in research.

FUNDAMENTO: En Brasil, la resolución 196/96 y sus complementaciones reglamentan la preservación de los derechos, del respeto y de la dignidad de los seres humanos implicados en investigaciones. OBJETIVO: Analizar la adecuación de los temas libres (TLs) presentados durante el XVIII Congreso Pernambucano de Cardiología a la resolución 196/96. MÉTODOS: Estudio de Corte Transversal. Se realizaron entrevistas con autores de los TLs presentados. Se analizaron los resúmenes de los trabajos con el objeto de identificar la necesidad de una previa aprobación por un Comité de Ética en Investigación (CEI). RESULTADOS: Se presentaron 90 TLs. La fuente de datos más utilizada fueron prontuarios médicos (86,8 por ciento). Solamente un 23,1 por ciento de los TLs fueron sometidos a la evaluación por un CEI y en el 15,4 por ciento se utilizó el Formulario de Consentimiento Informado (FCI). Entre los autores cuyos trabajos no se evaluaron por un CEI, el 65,6 por ciento afirmó que esta no era una conducta necesaria y el 18 por ciento de ellos desconocían la necesidad de llevar a cabo dicha evaluación. La autorización escrita del responsable por la institución donde los TLs fueron realizados no se obtuvo en un 56,6 por ciento de las investigaciones. La mayoría (80 por ciento) de los autores afirmó nunca haber leído la resolución 196/96. La proporción de los TLs sometidos a un CEI fue significativamente mayor entre autores que habían leído la resolución 196/96 (p = 0,005). El diseño de los TLs influenció la no sumisión de los trabajos a un CEI (p < 0,001). La mayoría de los TLs que fueron autorizados por el responsable de la institución donde se llevaron a cabo fue sometida a un CEI (p < 0,001). CONCLUSIÓN: La mayoría de los TLs presentados no se adecuó a las regulamentaciones brasileñas en ética en investigación.

Ethics in research with human beings: from knowledge to practice.

BACKGROUND: In Brazil, resolution 196/96 and its amendments regulate the preservation of rights, respect and dignity of human beings involved in research. OBJECTIVE: To analyze the adequacy of Free Communications (FC) presented during the XVIII Congresso Pernambucano de Cardiologia to resolution 196/96. METHODS: During a cross-sectional study, interviews were carried out with the authors of the FC presented at the Congress and the abstracts of the studies were assessed in order to identify the need for previous approval by a Research Ethics Committee (REC). RESULTS: A total of 90 FC were presented and, in most of them (86.8%), medical files were the most commonly used source of data. Only 23.1% of the FC were submitted to the assessment of a REC and 15.4% of them used a Free and Informed Consent Form (FICF). Among the authors whose studies were not assessed by a REC, 65.6% stated that this conduct was not necessary and 18% of them were unaware of the need to submit the study to such assessment. The written authorization given by the institution where the FC were carried out was not obtained in 56.6% of the studies. Most of the authors (80.0%) stated that they had never read Resolution 196/96. The proportion of FC submitted to a REC was significantly higher among authors that had read Resolution 196/96 (p = 0.005). The FC design influenced the non-submission of the studies to a REC (p < 0.001). Most of the FC that were authorized by the institution where they were carried out were submitted to a REC (p < 0.001). CONCLUSION: Most of the FC presented at the Congress did not follow the Brazilian regulations concerning the ethics in research.