What is the value of routinely testing
full blood count, electrolytes and urea,
Routine testing of FBC, U&E and PFTs before elective
and pulmonary function tests before
elective surgery in patients with no
apparent clinical indication and in
subgroups of patients with common
comorbidities: a systematic review
of the clinical and cost-effective
literature
surgery: a systematic review
C Czoski-Murray,1* M Lloyd Jones,2
C McCabe,1 K Claxton,3 Y Oluboyede,1
J Roberts,1 JP Nicholl,2 A Rees,2 CS Reilly,4
D Young5 and T Fleming6
1
Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
2
School of Health and Related Research, University of Sheffield,
Sheffield, UK
3
Centre for Health Economics, University of York, York, UK
4
Medical School, University of Sheffield, Sheffield, UK
5
John Radcliffe Hospital, Oxford, UK
6
Centre for Epidemiology and Biostatistics, University of Leeds,
Leeds, UK
*Corresponding author
Executive summary
Health Technology Assessment 2012; Vol. 16: No. 50
DOI: 10.3310/hta16500
Health Technology Assessment
NIHR HTA programme
www.hta.ac.uk
ii Executive summary: Routine testing of FBC, U&E and PFTs before elective surgery: a systematic review
Executive summary
Background
In 2003 the National Institute for Health and Clinical Excellence (NICE) published Clinical
Guideline 3, which reviewed the use of routine pre-operative tests prior to routine surgery.
Prior to the guideline preparation, a systematic review was undertaken by Munro et al. [Munro
J, Booth A, Nicholl J. Routine preoperative testing: a systematic review of the evidence. Health
Technol Assess 1997;1(12)] on behalf of the Health Technology Assessment programme in 1997.
The guideline development group undertook their own review of the literature. These two
reviews defined and updated the purpose of pre-operative testing of apparently healthy patients.
Of the evidence base used to produce the guideline, > 50% was graded as amber (i.e. the benefit
of the test was unknown). Therefore, despite the existence of some primary research, the evidence
on which to base pre-operative testing protocols was inconclusive. Alongside this there has
been an increasing awareness of the possibility of subjecting patients to unnecessary tests, and
of the issues involved in dealing with the results of tests that may alarm patients but have little
clinical significance.
Aims and objectives
The aims of this study were to estimate the clinical effectiveness and cost-effectiveness of
routine pre-operative testing of full blood count (FBC), electrolytes and renal function [urea
and electrolytes test (U&E)] and pulmonary function [pulmonary function test (PFT)] in adult
patients classified as American Society of Anaesthesiologists (ASA) grades 1 and 2 undergoing
elective minor (grade 1) or intermediate (grade 2) surgical procedures; to compare NICE
recommendations with current practice; to evaluate the cost-effectiveness of mandating or
withdrawing each of these tests in this patient group; and to identify the expected value of
information. This would determine whether or not there is value to the NHS in commissioning
further primary research into the use of these tests in this group of patients.
Methods
Systematic reviews of the literature relating to the clinical effectiveness of routine pre-operative
testing of FBC, electrolytes and renal function and pulmonary function in adult patients
classified as ASA grades 1 and 2 undergoing elective minor (grade 1) or intermediate (grade 2)
surgical procedures, and of the adverse effects of such testing, were carried out. Comprehensive
literature searches were undertaken in March to April 2008 and June 2009 to retrieve studies that
evaluated the clinical effectiveness of routine pre-operative utilisation of these tests in each of
the pre-defined patient/intervention combinations. The searches were not limited by language or
location, but were restricted to studies published from 1980 onwards.
Data were extracted by a single reviewer using a customised data extraction form based on
that proposed by the NHS Centre for Reviews and Dissemination for studies published in
English. Extracted data were checked by a second reviewer and disagreements were resolved by
discussion. Quality assessment was performed using a customised tool. Results were presented
Health Technology Assessment 2012; Vol. 16: No. 50 (Executive summary) iii
in a narrative summary; meta-analysis was not possible because of the diversity of outcome
measures used in the different studies.
A systematic review of the cost-effectiveness of the specified pre-operative tests in the above
patient group was also undertaken in order to identify papers in which cost-effectiveness of these
tests in the pre-defined indications had been modelled. The primary function of the review of
cost-effectiveness studies was to inform the development of a de novo cost-effectiveness model.
An exemplar cost-effectiveness model was constructed to identify the parameters for which
evidence would be required from the published literature.
Routine patient-level data sets of utilisation of pre-operative tests and patient outcomes were
identified at the Leeds Teaching Hospitals Trust. These data sets were linked and regression
models were used to estimate the impact of routine pre-operative tests on patient outcomes.
Finally, a postal survey of current practice pre-operative testing for the designated patient/
procedure combinations was sent to all UK NHS trusts in 2008. The survey was based on the
survey undertaken by NICE in 2005.
Results
The systematic literature searches identified a large number of potentially relevant studies of
clinical effectiveness. However, when these studies were subjected to detailed review, the evidence
base was found to be extremely small: only six observational studies met the review’s inclusion
criteria, none of which had been conducted in the UK. Five studies assessed the use of both FBCs
and U&E; only one study assessed the use of routine PFT. This limited evidence suggests that few
apparently healthy patients who undergo routine testing have abnormal test results, and even
fewer have both an abnormal result and a consequent change in clinical management.
The systematic review of adverse effects indicated that those most commonly reported in relation
to diagnostic venepuncture (pain and bruising, and, more infrequently, vasovagal reactions) are
generally not serious. However, nerve injuries may also occur; although these appear to be rare,
they are potentially disabling. Adverse events associated with PFT also appear to be unusual.
However, male patients with inguinal hernias appear to be at increased risk of incarceration of
that hernia.
The systematic literature searches of the cost-effectiveness literature identified a large number
of potentially relevant studies. Of 5151 references, only 282 papers were assessed as potentially
relevant after review of the title and abstract. Review of the full texts identified eight possible
papers, including one full economic evaluation and seven partial economic evaluations. None
of these eight papers provides data on the three tests under consideration for the specific
patient groups.
The postal survey had a 17% response rate. The majority of responding hospitals were district
general hospitals, and they reported that in ASA grade 1 patients aged < 40 years with no
comorbidities undergoing minor surgery did not undergo routine tests for FBC, electrolytes and
renal function and pulmonary function.
Analysis of the routine data indicated that that frequency of test use is not consistent with the
hypothesis of their routine use. FBC tests were performed in only 58% of patients in the data set
and U&E tests were carried out in only 57%.
iv Executive summary: Routine testing of FBC, U&E and PFTs before elective surgery: a systematic review
The primary limitation of the studies reported is driven by the paucity of the published evidence.
Although we included non-UK studies, we excluded non-English-language studies. These studies
may have been relevant to this review although concerns about equivalence of practice with
regard to characterisation of patients and clinical response to a given test result between the
UK NHS and non-English-speaking health-care systems meant that this would be a substantial
assumption. Owing in part to the almost complete absence of randomised data, we included
observational studies in the review and studies of this type are associated with an increased risk
of bias and confounding.
Conclusions
The paucity of the published evidence combined with the low response rate to the survey on
current practice means that conclusions from this study can be made only with great caution. It is
clear that there is not a robust evidence base to support the use of these tests in low-risk patients
undergoing ASA grade 1 and grade 2 elective surgery. Beyond this, the survey results suggest that
current practice has moved on and that the time of universal utilisation of pre-operative tests for
all surgical patients has passed. This routine data set provided by Leeds Teaching Hospitals Trust
is certainly consistent with this. However, these are data from only one trust.
The analysis of the Leeds Teaching Hospitals Trust routine data indicates that these tests are
used in patients in whom there is a reason to consider an underlying raised risk of a clinical
abnormality that should be taken into account in their clinical management. Although credible
that this strategy has led to substantial resource savings for the NHS, there is no published
evidence base to establish that this is the case. The total expenditure on pre-operative tests across
the NHS remains significant; however, this may well reflect increasing volumes in surgery in an
increasingly comorbid population owing to changing population demographics.
Recommendations for further research
Given the almost complete absence of published evidence on the clinical effectiveness, safety and
cost-effectiveness of routine use of these tests in uncomplicated patients undergoing ASA grade 1
and grade 2 procedures, any well-designed research would add to the current state of knowledge.
However, to recommend specific research questions it would be necessary for us to have a view
as to the value of additional information to decision-makers in the UK NHS. To assess the likely
value of such research it would be necessary to have a robust assessment of the current scale of
the routine use of these tests in patient/procedure combinations of interest.
The low response rate to our survey, despite significant efforts at follow-up, suggests that this type
of survey will not be a satisfactory strategy for scoping the scale of the research opportunity. A
systematic identification of routine test databases held by UK NHS trusts is necessary to establish
the feasibility of undertaking a multicentre version of the routine data analysis that we report for
Leeds Teaching Hospitals Trust.
If feasible, this would allow the identification of the scale of the use of these tests in practice and
the degree to which they are being used in otherwise healthy patients, rather than in response to
a specific clinical indication. Only once this information is available will it be possible to establish
whether or not any further research in this area is required and, if so, which research questions
have the greatest potential value to the UK NHS.
Health Technology Assessment 2012; Vol. 16: No. 50 (Executive summary) v
Funding
Funding for this study was provided by the Health Technology Assessment programme of the
National Institute for Health Research.
Publication
Czoski-Murray C, Lloyd Jones M, McCabe C, Claxton K, Oluboyede Y, Roberts J, et al. What is
the value of routinely testing full blood count, electrolytes and urea, and pulmonary function
tests before elective surgery in patients with no apparent clinical indication and in subgroups
of patients with common comorbidities: a systematic review of the clinical and cost-effective
literature. Health Technol Assess 2012;16(50).
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