Author: Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew
Title: Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention Document date: 2016_6_22
ID: txfrcrub_30
Snippet: As there are no planned interim analyses and stopping rules for this study, a formal committee for data monitoring is not required. At the start of the trial, the outcome assessor will undergo training in interviewing patients using the satisfaction in ICU questionnaires, and HADS. A senior author will periodically audit the integrity of the randomisation, source data verification of the paper data collection forms, and overall quality and comple.....
Document: As there are no planned interim analyses and stopping rules for this study, a formal committee for data monitoring is not required. At the start of the trial, the outcome assessor will undergo training in interviewing patients using the satisfaction in ICU questionnaires, and HADS. A senior author will periodically audit the integrity of the randomisation, source data verification of the paper data collection forms, and overall quality and completeness of the data. Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care. Only group data will be published. The first, fourth and corresponding authors will have access to the final data set. It is anticipated that there will be no serious adverse events caused by trial patient education intervention.
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