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 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 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.

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