Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial.

Objectives: To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial.

Design: Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability.

A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance.

Objective: Good clinical practice (GCP) guidelines emphasize trial site monitoring, although the implementation is unspecified and evidence for benefit is sparse. We aimed to develop a site monitoring process using peer reviewers to improve staff training, site performance, data collection, and GCP compliance.

Study Design And Setting: The Peer Review Intervention for Monitoring and Evaluating sites (PRIME) team observed and gave feedback on trial recruitment and follow-up appointments, held staff meetings, and examined documentation during annual 2-day site visits.

Phase I evaluation of intranasal trivalent inactivated influenza vaccine with nontoxigenic Escherichia coli enterotoxin and novel biovector as mucosal adjuvants, using adult volunteers.

Trivalent influenza virus A/Duck/Singapore (H5N3), A/Panama (H3N2), and B/Guandong vaccine preparations were used in a randomized, controlled, dose-ranging phase I study. The vaccines were prepared from highly purified hemagglutinin and neuraminidase from influenza viruses propagated in embryonated chicken eggs and inactivated with formaldehyde. We assigned 100 participants to six vaccine groups, as follows.