Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms.

Background: Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, including enhancing oversight, improving reliability of central monitoring techniques and helping prepare for database lock and trial analyses. Despite this, there is little evidence to support best practice, and current standard methods may not be optimal.

Methods for delivering the UK's multi-centre prison-based naloxone-on-release pilot randomised trial (N-ALIVE): Europe's largest prison-based randomised controlled trial.

Introduction And Aims: Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin use by injection have a high risk of drug-related death in the first weeks after prison-release. The N-ALIVE trial was planned as a large prison-based randomised controlled trial (RCT) to test the effectiveness of naloxone-on-release in the prevention of fatal opiate overdoses soon after release.

Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): an open-label, randomised, controlled, non-inferiority trial.

Background: The international standard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy. We aimed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen.

Methods: In this phase 3, non-inferiority, randomised, controlled trial (CHORUS) undertaken in 87 hospitals in the UK and New Zealand, we enrolled women with suspected stage III or IV ovarian cancer.

[Evaluation experiences of the supplementary care sector: contributions of integrality].

This work identifies aspects of comprehensiveness in the proposals for healthcare evaluation of the Agência Nacional de Saúde Suplementar (ANS) in Brazil, and of the National Commitee Quality Assurance (NCQA) in the U.S.A.

[Political, institutional, and organizational evaluation of primary health care with an emphasis on comprehensiveness].

This article presents part of the data from an evaluation of primary care, implemented as part of research funded by the Brazilian Ministry of Health in 2005. Thirty-one municipalities from the States of Minas Gerais and Espírito Santo comprised the study sample. Data collected with qualitative methods (interviews and documents) were summarized, with the production of a set of categorical variables.

[Adolescents and their relationship to health services: a school-based cross-sectional study in Niterói, Rio de Janeiro, Brazil].

This cross-sectional study describes the relationship between adolescents and health services using several indicators (self-reported diseases, self-rated health status, the need and search for health care, health care utilization and fidelity, adherence to medical prescription) and their association with socio-demographic variables. The adolescents (aged 12 to 17 years) were enrolled in schools from a district in Niteroi, Rio de Janeiro State, Brazil. Type of school, representing the participants' socioeconomic status, was associated with all the indicators.

Co-selection of the H63D mutation and the HLA-A29 allele: a new paradigm of linkage disequilibrium?

The major histocompatibility complex (MHC) shows a remarkable conservation of particular HLA antigens and haplotypes in linkage disequilibrium in most human populations, suggesting the existence of a convergent evolution. A recent example of such conservation is the association of particular HLA haplotypes with the HFE mutations. With the objective of exploring the significance of that association, the present paper offers an analysis of the linkage disequilibrium between HLA alleles or haplotypes and the HFE mutations in a Portuguese population.