Abdomen, Acute Clinical Trial
Official title:
The Hospital Volume Relationship in Emergency Laparotomy Outcomes
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.
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.
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 mortality differences. A recent paper showed 30 day mortality for emergency
laparotomy to be 14.9% (Saunders DI, Murray D, Pichel AC, Varley S, Peden CJ. Variations in
mortality after emergency laparotomy: the first report of the UK Emergency Laparotomy
Network. Br J Anaesth. 2012 Sep 1;109(3):368-75.)
We decided that we wanted to be able to detect a mortality difference (absolute) of 2%.
Alpha was specified as 0.05 and power 0.9. Using a chi-2 test in G Power 3.1.7, it was
determined that a total N of 5221 was required to show this difference. In the study already
cited, 35 hospitals submitted data on 3 months of practice, giving a total of 1853 patients.
We extrapolated to estimate that one hospital completes 212 laparotomies per year. There are
currently 31 adult surgical centres in Scotland, resulting in an estimate of 6,565
laparotomies per year. Even accepting the smaller size of Scottish hospitals, this
demonstrates that a 10 year cohort should be more than adequate 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.
The study will compare risk-adjusted 30 day/in-patient mortality as the primary outcome,
with secondary outcomes of 30 day re-admission rate, 30 day re-operation rate and
post-operative length of stay. 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.
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Observational Model: Ecologic or Community, Time Perspective: Retrospective
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