The Hospital Volume Relationship in Emergency Laparotomy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Introduction
'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which are known to carry a significant risk of mortality and morbidity. Previous work has shown considerable inter-hospital variation in emergency laparotomy outcomes within the United Kingdom. It is unknown whether there are significant differences in outcomes following laparotomy which may be explained by differences in hospital procedural volume.
Aims
The aim of this study is to compare emergency laparotomy outcomes in Scotland as they vary by hospital procedural volume.
Methods
This research study is a retrospective observational enquiry which will utilise administrative data from the Information Services Division (ISD) of NHS National Services Scotland. Patient episodes will be identified by a set of procedure codes for emergency laparotomy.
The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary outcome measures will be 30 day readmission rate, 30 day re-operation rate and length of stay.
详细描述
The aim of this study is to explore the possibility of a hospital procedural volume-outcome relationship in Scottish emergency laparotomy outcomes.
This is a retrospective study of all emergency laparotomies performed in Scotland during the period from 1st January 2001 - 31st December 2010. It will use routinely collected administrative data from the Information Services Division (ISD) of NHS National Services Scotland.
Emergency laparotomy will be defined as a non-elective abdominal procedure primarily on the gut tube; and such cases will be identified by the use of a set of procedural codes, which will be validated against local records.
The registry which will supply the data for this study is the Scottish Morbidity Record 01 (SMR01), the full title of which is the "General / Acute Inpatient and Day Case dataset" (see http://www.adls.ac.uk/nhs-scotland/general-acute-inpatient-day-case-smr01/?detail). SMR01 is collated and administered by ISD, and data submission is mandatory for all Scottish NHS providers of in-patient or day-case care. Approximately 1.4 million records are added each year. Diagnoses are coded according to International Classification of Diseases (ICD)-10 standards and procedures are coded according to the United Kingdom's Office of Population Census Statistics (OPCS) standards, the most current of which is version 4.5. The data quality in SMR01 is high and is assured by regular internal audits. In the 2010 audit of accuracy, Main Condition was recorded with an accuracy of 88% and Main Procedure was recorded with an accuracy of 94%.
Where data inconsistencies are identified in the extract supplied for this study, further clarification will be obtained where possible with ISD's data retrieval support team. Data completeness is very high in SMR01. However, where significant volumes of data are missing or unusable, the need for data imputation will be explored.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18 years or older who undergo emergency laparotomy within the study period
排除标准
- •Patients who are non-resident in Scotland
- •Multiple laparotomies on a single patient will not be counted as separate index events unless ≥6 months have passed between previous discharge and new hospital admission.
结局指标
主要结局
Mortality
时间窗: Either within 30 days of procedure, or during continuous in-patient stay (up to 12.5 years)
Death as an in-patient or ≤30 days of procedure. This is a retrospective study using a complete national data set, with the first admission 12.5 years distant from the time of data collection, and the last admission 2.5 years prior to the time of data collection. The theoretical maximal length of stay is 12.5 years. Deaths will be recognised from SMR01 which is linked to the Registrar General's database of deaths.
次要结局
- Re-admission(Within 30 days of index discharge)
- Re-operation(Within the index admission (theoretically, up to a maximum of 12.5 years) or within 30 days of discharge)
- Post-operative length of stay(From date of laparotomy to date of discharge (whole days) - up to 12.5 years)