The Hospital Volume Relationship in Appendicectomy Outcomes
Background
Appendicitis is a common condition which represents a significant resource burden for the Scottish National Health Service (NHS). It is unknown whether there are significant differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by hospital volume. In many studies, hospital procedural volume has been shown to be predictive of surgical outcomes.
Aims
The aim of this study is to compare appendicectomy 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 procedure codes for appendicectomy. A 10 year period will be studied, from January 2001 to December 2010.
Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.
研究概览
地位
条件
详细说明
The aim of this study is to explore the possibility of a hospital volume-outcome relationship in Scottish appendicectomy outcomes.
This is a retrospective study of all appendicectomies 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.
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 recent 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.
The study period was decided on pragmatically by a desire to provide an assessment of current practice, fully within the era of widely practised laparoscopic surgery. A power calculation also suggested that this would provide an adequate sample size to demonstrate differences.
Our power calculation- specific to length of stay- was based on Faiz O, Clark J, Brown T, Bottle A, Antoniou A, Farrands P, et al. Traditional and Laparoscopic Appendectomy in Adults. Ann Surg. 2008 Nov;248(5):800-6. In their cohort of 259,735 appendicectomies performed from 1996-2006, the geometric mean length of stay was 3.52, with SD 1.8. We decided that a difference of 0.5 days would be 'clinically significant'. We specified alpha 0.05 and Power 0.9, and an allocation ratio of 2 (allowing comparison of one tertile to two others). A two-sided t-test of difference between two independent means was performed in G*Power 3.1.7. This demonstrated that a total N of 616 was required to demonstrate this difference. According to ISD figures, there were 3,712 appendicectomy procedures performed in 2010/11, so we will be able to detect a clinically significant difference in length of stay.
Hospitals will be placed into tertiles of high, medium and low volume, according to the number of procedures performed over the study period.
In the absence of a literature standard appendicectomy outcome measure, the following will be assessed as primary outcome measures: 30 day/in-patient mortality, 30 day re-admission rate, 30 day re-operation rate, post-operative length of stay and negative appendicectomy rates between these 3 groups. Potentially significant confounding variables such as age, gender, and co-morbidity will be studied for their predictive value in a univariate model and included in a multivariate model if they remain significant.
研究类型
注册 (预期的)
联系人和位置
学习地点
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All Scottish surgical facilities、英国
- All Scottish NHS Hospitals
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 - December 2010.
Exclusion Criteria:
- Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure.
- Patients non-resident in Scotland
学习计划
研究是如何设计的?
设计细节
- 观测模型:生态或社区
- 时间观点:追溯
队列和干预
团体/队列 |
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High volume hospitals
The hospitals in the upper tertile for procedural volume
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Medium volume hospitals
The hospitals in the middle tertile for procedural volume
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Low volume hospitals
The hospitals in the lowest tertile for procedural volume.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Post-operative length of stay
大体时间:From date of appendicectomy to date of discharge (whole days) - see below
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(Whole) days from date of laparotomy to date of discharge.
Because this is a retrospective study using a complete national data set, with the last admission 2.5 years distant from the time of data collection, we will use actual time period rather than censoring length of stay at a set point.
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From date of appendicectomy to date of discharge (whole days) - see below
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Re-operation
大体时间:Within the index admission or within 30 days of discharge
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The occurrence of an abdominal procedure either subsequent to appendicectomy and within the index admission, or ≤30 days of discharge.
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Within the index admission or within 30 days of discharge
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重新入场
大体时间:指数发布后 30 天内
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自出院之日起 ≤ 30 天后再次入院任何医院专科。
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指数发布后 30 天内
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死亡
大体时间:手术后 30 天内或连续住院期间
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作为住院患者死亡或 ≤ 30 天的程序。
死亡将从 SMR01 中识别出来,SMR01 与注册总署的死亡数据库相关联。
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手术后 30 天内或连续住院期间
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Negative Appendicectomy Rate
大体时间:At time of index procedure
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The rate of appendicectomies performed in which the appendix is found to be normal.
This will be detected by the use of ICD-10 codes.
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At time of index procedure
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- XRB13069-VA
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