Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia

Background: Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. Objective: To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. Design, setting, and participants: A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. Intervention: Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. Outcome measurements and statistical analysis: An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. Results and limitations: Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. Conclusions: The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. Patient summary: Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.info:eu-repo/semantics/publishedVersio

Family Health Reform in Portugal : analysis of its implementation

ACESSO via B-on: http://dx.doi.org/10.1590/S1413-81232011000600023Primary healthcare in Portugal is undergoing a major reform, of which family health units (FHU) are one of the more visible results. This study aimed to evaluate the FHU implementation process from 2006 onwards. Methods from a previous study of primary healthcare implementation in Brazil were used. Dimensions studied included comprehensiveness of care, organization of care, and the political-institutional perspective. The main improvements identified included better availability of care, team work, technical quality of care, innovative management practices, sustainability of the model, working conditions and infrastructure improvements. Main challenges remaining include integration with hospital care, political and institutional gray areas, need for better information systems, integration within health centers and workflow organization. These data may be useful for management decision-makers when making adjustments and corrections in the reform process. Os cuidados de saúde primários de Portugal estão em processo de reforma, sendo as Unidades de Saúde Familiar (USF) uma das principais marcas desse processo. Este estudo teve como objectivo avaliar o processo de implantação das USF a partir de 2006. Utilizou-se metodologia de análise de implantação na mesma área de atenção primária em saúde de um estudo anterior no Brasil. Na análise foram empregadas as dimensões do cuidado integral, da organização dos cuidados e político-institucional. Evidenciaram-se como avanços principais a acessibilidade, trabalho em equipe, qualidade (técnico-científica) dos cuidados, inovações nas práticas de gestão, na sustentabilidade (condições de trabalho) e infraestrutura. Principais desafios: integração com especialidades hospitalares, indefinições político-institucionais, sistemas informatizados, integração nos centros de saúde e organização do processo de trabalho. Estes dados poderão vir a informar os decisores de gestão sobre correções a efetuar no processo de reforma