An Observational Cohort Study to Explore Patient Outcome From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Change in Impact of Events scores
研究概览
简要总结
This study will describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.
详细描述
The overall aim of this study is to describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.
All adult patients having cardiac surgery during the pandemic at St Bartholomew's Hospital will be approached to join this study. As of the end of March this is this is approximately 20 operations a week. Questionnaires will be administered at five time points alongside a review of clinical notes.
Appropriate descriptive and summative statistics will be used to analyse outcomes. If sample size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each of the recovery parameters included in the study will be determined. The differences in outcomes between those with and without covid-19 may also be analysed if the sample size is adequate. Bias and loss to follow-up in observational cohort studies has been considered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing cardiac surgery during the Covid-19 pandemic (end date as yet unknown but inferred when elective surgery is reinstated)
- •Discharge from hospital where operation was performed is being planned
- •Able and willing to give informed consent
排除标准
- •Unable or unwilling to give written informed consent. This includes patients who are being transferred to another hospital and are considered too vulnerable or unwell to be approached (based on clinical judgement of the clinical care team)
- •Unable or unwilling to give and/or complete the questionnaires
- •Inability to understand written and/or verbal English
结局指标
主要结局
Change in Impact of Events scores
时间窗: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
The revised Impact of Events revised version (IES-R) questionnaire (Weiss and Marmar, 1997) is widely used as a measure of event-specific distress and measures distress experienced by serious life changes/events. It has been commonly used to assess persons with posttraumatic stress disorder (PTSD). It is an 22 item self-report scale where is item is reported on a five point likert scale from 0 (not at all) to 4 (extremely) with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items: 1, 2, 3, 6, 9, 14, 16, 20), avoidance (8 items: 5,7,8,11,12,13,17,22), and hyperarousal (6 items: 4,10,15.18.19.21). A cut-off of 26 and above has been suggested for a clinically significant reaction to a psychological trauma, although the IES alone does not diagnose PTSD or reflect a person's ability to function. Metric for summarising data: t-test
次要结局
- Survival(Up to 1 year post surgery)
- Morbidity(Up to 1 year post surgery)
- Change in Health-related quality of life scores(Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery)
- Change in Depression scores(Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery)