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

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Chapter 1 Introduction

The pre-operative preparation of patients undergoing any surgery involves a multidisciplinary approach. The surgical team assess the appropriateness of the surgery and the anaesthetists assess the patient’s fitness for surgery. The development of pre-operative assessment clinics in the last 20 years has seen nursing staff take a key role in the assessment preparation of patients for surgery. Protocols were developed and implemented locally to facilitate the patient care pathway in an environment where skill mix within teams was evolving.

In 2003 the National Institute for Health and Clinical Excellence (NICE) published Clinical Guideline 3 (CG3), which reviewed the use of routine pre-operative tests prior to routine surgery. 1 Prior to the guideline preparation, a systematic review was undertaken by Munro et al. 2 on behalf of the Health Technology Assessment (HTA) programme in 1997. The guideline development group undertook its 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.

The OPCECK study, undertaken in 19993 by members of this research team, suggested that it was somewhat difficult to attribute pre-operative examination and testing to perioperative and post-operative outcomes for patients. This study was designed to evaluate the performance of appropriately trained nurses and house officers in pre-operative assessment. Both the nurses and doctors were assessed by a clinical fellow in anaesthesia in the areas of clinical examination, history taking and ordering of appropriate tests for the patient. The nurses adhered to test ordering by following local protocols and thus performed far better at this task than junior doctors, who overinvestigated. The outcomes of interest in this study were the correct assessment of the patient, overassessment, underassessment not affecting management and underassessment possibly affecting management. The last was the primary outcome. Patients were followed up to establish if admission and surgery had proceeded as planned. Cancellation of surgery after the assessment clinic for any reason was noted as was the ordering of any additional tests by the surgeon or anaesthetist on admission.

It was difficult in this study to establish the link between patient outcomes and the quality of their pre-operative assessment. Test results were often outwith normal limits but the surgery went ahead anyway as the anaesthetist used his or her clinical judgement to assess the risks to the patient. Linking any change in clinical management resulting from a biochemistry test carried out pre-operatively was problematic.

The NICE review of the evidence that produced the guidelines identified change in clinical management as a result of a pre-operative biochemistry test as an outcome measure. 1 They found that, although some studies reported this as an outcome, they did not refine this further than delay, cancellation and alteration of treatment. Nor did this include any further explanation of what the change comprised or its impact on patients. 1

Answering these questions is central to understanding the need for and the impact of pre-operative biochemistry testing on patients who meet the criteria within the guidelines.

Being able to demonstrate that a test was carried out or not carried out as per protocol has little relevance unless the outcomes for patients are improved by these actions. This could be either by avoiding an unnecessary test or by avoiding complications by actions taken on the results of an abnormal test.

Of the 3 million or so surgical procedures carried out in the UK every year, a significant number of patients will be in the category of interest to this review. Although many of these tests are individually cheap, the NHS spends literally millions of pounds each year on tests.

Previous reviews4,5 were wide-ranging and included a wide range of patients, surgical procedures and tests. By contrast, this review is highly focused in terms of the tests, patients and surgeries under consideration. These are defined below.

Chapter 2 Clinical effectiveness

Results

Quantity and quality of research available

Number of studies of clinical efficacy identified

The electronic literature searches identified 11,953 potentially relevant articles. Of these, four articles related to four studies9,11–13 which met the review’s inclusion criteria (Figure 1).

FIGURE 1.

Clinical effectiveness: summary of study selection and exclusion (electronic literature searches).

Two additional relevant studies, by Roukema et al. 14 and Turnbull and Buck,15 were identified only from citations.

Number and type of studies included

Six studies9,11–15 met the inclusion criteria for the review of clinical effectiveness; none was a RCT of pre-operative testing. A pseudo-randomised trial by Roukema et al. 14 used year of birth to allocate patients to treatment groups; it studied the effectiveness of pre- and post-operative breathing exercises in preventing pulmonary complications after upper abdominal surgery. However, because all participants underwent pre-operative PFTs, data from the control group could be utilised in the current review as a prospective case series examining the ability of such testing to predict pulmonary complications (see Quantity of research available). The remaining five studies were designed as prospective or retrospective case series. 9,11–13,15

Number and type of studies excluded, with reasons

As may be seen from Number of studies of clinical efficacy identified, a substantial number of the references identified by the electronic searches related to studies which did not meet the review’s inclusion criteria, and which were therefore excluded during the sifting process. Details are therefore given only of those references which:

• appeared potentially relevant, but could not be obtained

• were excluded after a full reading, if the reason for exclusion is potentially not readily apparent from the full text; or

• might appear from their titles to be particularly pertinent to the subject of the review.

Such references are listed in Appendix 4, together with the reasons for their exclusion.

Quantity and quality of research available

Quantity of research available

As noted above, six studies were identified which reported results relating to one or more of the three tests in adult patients in ASA grades 1 and 2 (Table 1). 9,11–15 Although Gnocchi et al. 11 included in their study patients in ASA grades 1–3, routine testing was performed only in ASA grade 1 patients (tests for patients in ASA grades 2 and 3 were requested according to the conditions identified by, or suspected from, the clinical history and examination). Consequently, only the results relating to ASA grade 1 patients are relevant to, and included in, this review. Roukema et al. 14 and Turnbull and Buck15 did not specify the ASA status of their patients, but described them in terms which strongly suggest that they would appropriately have been categorised as ASA grade 1 or 2; these studies have therefore been included.

TABLE 1 - Details of included studies of routine pre-operative testing, by alphabetical order of author

FEV₁, forced expiratory volume in 1 second; GA, general anaesthetic; i.v. intravenous.

Study	Country	Study design	Date of operation	All tests routine	Relevant tests	Number of patients	Age range (mean) (years)	ASA status	Operation type (risk classification)
Gnocchi et al. 200011	Argentina	Prospective case series	1 September 1995 to 30 April 1998	Yes	Aged 16–59 years: haemogram Aged ≥ 60 years: haemogram, plasma creatinine	214	≥ 16 (ASA grade 1 47.8 ± 19.6; ASA grade 2 61.0 ± 16.5)	1	Abdominal surgery including hernia repair, laparoscopic cholecystectomy and benign proctological surgery (2 or 3)
Haug and Reifeis 199913	USA	Prospective case series	1 February 1994 to 30 November 1994	Yes	FBC, Hb, haematocrit, platelet count, mean corpuscular Hb, mean corpuscular volume, lymphocyte count, mean corpuscular Hb concentration	458 enrolled (GA: 281; i.v. sedation: 177) 380 returned for scheduled procedure (GA: 235; i.v. sedation: 145)	15–54 (23.4)	1 or well-controlled 2	Dental surgery under general anaesthetic or i.v. sedation (Not specified)
Roukema et al. 198814	Netherlands	Pseudo-RCT/prospective case series	No data	Yes	PFT (vital capacity and FEV1)	84 in control group	≤ 70; implicitly limited to adults	Not specified; patients described as ‘without pre-operative risk factors’	Upper abdominal surgery for benign biliary disease or duodenal ulcer (Not specified)
Szmuk et al. 20029	Israel	Retrospective case series	No data	Yes	Determined by the surgeon; included blood count, urea nitrogen, electrolytes	300	18–40	1	Unspecified (‘Minor’)
Tallo et al. 200712	Brazil	Retrospective case series	January 2005 to December 2005	Not clear	Hb, haematocrit, serum sodium, serum potassium, creatinine	1254	Implicitly adult (ASA grades 1–3 68.1 ± 11.6)	1–3; individual patient data provided for all patients suffering adverse events	Cataract surgery (2)
Turnbull and Buck 198715	Canada	Retrospective case series	1973–84	Not clear	Any screening tests received by the patient, including complete blood cell count, sodium, potassium, creatinine, urea	1010	Implicitly adult	Not specified; patients described as ‘otherwise healthy’ (i.e. apart from the need for cholecystectomy) and as having no other ‘active or ongoing disease on admission to hospital’	Cholecystectomy (Not specified)

The studies related to three surgical specialties:

• general surgery (including cholecystectomy,15 abdominal surgery,11 upper abdominal surgery14 and unspecified ‘minor’ surgery9)

• ophthalmology (specifically cataract surgery12)

• dentistry13 (see Table 1).

Five studies assessed the use of both FBCs and U&Es. 9,11–13,15 Only one study, that by Roukema et al. ,14 assessed the use of routine PFTs. The paucity of data relating to routine PFTs reflects the fact that this test is seldom routinely performed in asymptomatic patients; thus, Turnbull and Buck’s retrospective review15 of records relating to 1010 patients found that only three PFTs were performed, in each case in a patient whose history or physical examination had suggested some abnormality of pulmonary function.

Only one study, that by Szmuk et al.,9 specifically met the original criterion that all patients should fall within the 16–60 years age group (see Table 1). Of the remainder, the studies by Roukema et al. ,14 Tallo et al. 12 and Turnbull and Buck15 did not explicitly state that the study population was limited to adults; however, these studies have been retained as there is no indication that they included children.

As noted in Number and type of studies included in this review, data from the control group of Roukema et al. ’s pseudo-RCT14 of pre- and post-operative breathing exercises in preventing pulmonary complications after upper abdominal surgery are utilised as a prospective case series examining the ability of routine pre-operative PFTs to predict pulmonary complications.

The remaining studies were designed as case series. Two of these were prospective:

• Gnocchi et al. 11 studied all ASA grade 1–3 patients, aged ≥ 16 years who were scheduled for elective abdominal surgery classified as grade 2 (low risk) or 3 (moderate risk) by the Johns Hopkins Risk Classification System in one hospital in Argentina between 1 September 1995 and 30 April 1998. As noted above, routine testing was undertaken only in patients in ASA grade 1.

• Haug and Reifeis13 included all ASA grade 1 or 2 patients aged 15–54 years undergoing dental surgery under general anaesthesia or intravenous sedation in one American oral and maxillofacial surgery clinic between 1 February and 30 November 1994.

The remaining three case series were retrospective record reviews:

• Szmuk et al. 9 reviewed the records of 300 ASA grade 1 patients aged 18–40 years who had undergone minor elective operations (most commonly hernia repair) in an Israeli public hospital at an unspecified point in time.

• Tallo et al. 12 reviewed the records of 1254 patients who had undergone cataract surgery in a single hospital in Brazil between January and December 2005.

• Turnbull and Buck15 reviewed the records of 1010 otherwise healthy individuals who had undergone cholecystectomy in two Canadian teaching hospitals between 1973 and 1984.

Quality of research available

Quality assessment using the customised tool described in Quality assessment strategy suggested that the prospective studies were of higher quality than the retrospective record reviews (for details see Appendix 5). However, in some instances this may reflect reporting quality rather than the quality of the study design. So, for example, Szmuk et al. 9 and Turnbull and Buck15 do not specify that the records that they reviewed were those of consecutive patients who met the study’s inclusion criteria, although this seems probable. Furthermore, Turnbull and Buck15 do not make it entirely clear whether or not all the operations were elective. Moreover, as they talk throughout about the number of tests performed, rather than the number of patients tested, it is not wholly clear that each test was performed only once in each patient, nor is it specified that the blood counts and multiphasic screening tests (which included tests for urea and electrolytes) were routinely performed, although this seems likely since, if each test was performed only once in each patient, > 98% of patients would have undergone these tests. Turnbull and Buck15 also failed to provide definitions of normal or abnormal results. Tallo et al. 12 also failed to specify whether or not the tests they reported were routine although, again, this seems probable; the very high proportion of patients with at least one abnormal test result suggests that most, if not all, underwent testing (see Full blood counts).

Several studies may be biased because of attrition. In the study by Gnocchi et al. ,11 777 patients in ASA grades 1–3 attended an Argentine hospital for pre-operative evaluation, but only 507 (62.3%) returned for surgery; the primary reason why the remaining 270 did not do so was lack of insurance cover for medical expenses. As noted above, Gnocchi et al. 11 undertook routine testing only in patients in ASA grade 1, but it is not clear how many of the original 777 patients were assessed as being in grade 1 because test results are presented only for the 214 grade 1 patients who returned to the hospital for a second interview, of whom 210 (98.1%) were deemed to be fit for surgery, but only 139 (66.2%) actually underwent the operation for which they were scheduled; again, the main reason why the remainder did not appeared to be lack of cover for medical expenses. No details were given of the health status of those patients who dropped out at either point in the study compared with those who underwent their scheduled operation, and therefore the study incorporates the potential for systematic bias at both points. Although attrition was lower in Haug and Reifeis’ study13 of patients undergoing dental surgery in the USA, 78 of 458 patients (17%) failed to return on the appointed day. The remaining four studies9,12,14,15 are less explicit about the pathway from assessment to operation, and the degree of attrition involved; they may also contain a potential for bias, related to financial or other, unknown, factors.

Assessment of clinical effectiveness

Because the included studies had different aims, they did not all report the same data. It has therefore been necessary to summarise each study on its own terms before attempting to compare their findings.

Full blood counts

The prospective case series by Gnocchi et al. 11 assessed:

• the prevalence of asymptomatic disease in ASA grade 1 patients

• the frequency of diagnoses which led to the cancellation or postponement of surgery in such patients

• the incidence of perioperative complications in those patients who underwent surgery.

As noted in Quality of research available, it is not clear how many ASA grade 1 patients originally entered the study; results are presented only for the 214 who returned to the hospital for a second interview. In addition, it is not clear how many of this 214 were scheduled for grade 2 operations, and how many for grade 3. The number of ASA grade 1 patients with abnormal test results was not reported, although three patients initially classified as ASA grade 1 were reclassified as ASA grade 2 as a result of a diagnosis of hypertension (a reconstruction of the apparent patient flow is represented diagrammatically in Appendix 6). Moreover, as published, the results relating to the cancellation or postponement of surgery appear potentially contradictory: on the one hand, four ASA grade 1 patients (1.9%) were said to have had their operations postponed as a consequence of routine testing, but, on the other hand, the authors claimed that no operation was postponed or cancelled because of an unknown disease and stated that, in asymptomatic (i.e. ASA grade 1) patients, routinely requested laboratory tests showed no benefit in terms of either anaesthetic management or the detection of pathologies. All four ASA grade 1 patients whose operations were postponed had severe asymptomatic anaemia (Hb < 8 mg/dl).

As noted above, Gnocchi et al. 11 found that only 139 of the 210 ASA grade 1 patients deemed fit for surgery (66.2%) actually underwent the operation for which they were scheduled; the reason why the remaining 71 patients did not do so appeared to be lack of cover for medical expenses rather than any medical reason. One hundred and thirty of the 139 who underwent surgery had grade 2 operations; none suffered intraoperative complications and, although four had post-operative complications, a rate of 3.08% (95% CI 0.11% to 6.05%), these complications were considered to be unrelated to the pre-operative tests (two patients had wound infections, one had a haemorrhage from the site of the surgical drain which stopped spontaneously without requiring a blood transfusion and one had a clinical lower limb deep-vein thrombosis). There were no intraoperative or post-operative deaths in ASA grade 1 patients undergoing grade 2 operations.

The other prospective case series, that by Haug and Reifeis,13 sought to determine whether or not routine laboratory testing affected clinicians’ pre-operative evaluation and clinical decision-making. Seven of the 380 patients who returned for their dental procedure had an abnormal test result, a rate of 1.8% (95% CI 0.5% to 3.2%): three had borderline low red blood cell counts, one had borderline low haematocrit, one had a borderline low white blood count and two patients being treated for dentoalveolar abscesses had elevated white blood cell counts. No planned procedures in these patients were postponed, and the authors concluded that the routine laboratory tests had little or no effect on the clinicians’ decision-making process.

Szmuk et al. 9 evaluated the clinical benefit and cost of routine screening. Only nine patients were found to have abnormal test results, a rate of 3.0% (95% CI 1.1% to 4.9%). All nine had light anaemia (11–12 g), which in each case was attributed to increased menstrual flow and was consonant with the case history or physical examination. No operations were cancelled or delayed as a consequence of the test results. Szmuk et al. 9 therefore suggested that blood counts should not be routinely undertaken before minor operations in healthy patients, but should be performed only when indicated by the patient’s age, gender, case history and the findings of the physical examination.

Tallo et al. 12 sought to determine whether or not pre-operative testing prevented pre- and post-operative adverse events in patients in ASA grades 1–3 undergoing cataract surgery. Seventy-five per cent of these patients had at least one recorded abnormal result on a range of tests, which included fasting blood glucose, electrocardiography (ECG) and chest radiography, as well as Hb, haematocrit, serum sodium, potassium and creatinine. However, only 1.3% had an adverse clinical event which was considered to be related to the anaesthesia or surgery (Table 2), and no relationship was observed between abnormal test results and adverse events (chi-squared p = 0.334). One hundred and eighty-one patients (14%) were referred to a specialist for pre-operative assessment, of whom 104 were asymptomatic (57.5%; 95% CI 50.3% to 64.7%). Only 20% of these asymptomatic patients underwent any clinical intervention as a consequence of the specialist assessment, compared with 86% of symptomatic patients (Table 3). The blood count result was abnormal in only 1 of the 13 patients in ASA grades 1 or 2 who had an adverse clinical event that was considered to be related to the anaesthesia or surgery (Table 4).

TABLE 2 - Abnormal test results in all ASA grade 1–3 patients undergoing cataract surgery (data from Tallo et al.12)

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Patient outcomes	Number	Rate	95% CI
Patients with at least one abnormal test result	936/1254	74.6%	72.2% to 77.1%
Patients referred for specialist assessment (includes symptomatic and asymptomatic patients)	181/1254	14.4%	12.5% to 16.4%
Patients who had an adverse clinical event considered to be related to the anaesthesia or surgery	16/1254	1.3%	0.7% to 1.9%

TABLE 3 - Relationship between presence of symptoms and change of management in ASA grade 1–3 patients undergoing cataract surgery and referred for specialist pre-operative assessment (data from Tallo et al.12)

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Patients referred for specialist assessment	Clinical intervention consequent on specialist pre-operative assessment
	No	Yes
Asymptomatic	83/104 (79.8%, 95% CI 72.1% to 87.5%)	21/104 (20.2%, 95% CI 12.5% to 27.9%)
Symptomatic	11/77 (14.3%, 95% CI 6.5% to 22.1%)	66/77 (85.7%, 95% CI 77.9% to 93.5%)

TABLE 4 - Clinical adverse events in ASA grade 1 and 2 patients undergoing cataract surgery (data from Tallo et al.12)

F, female; M, male; MI, myocardial infarction.

ASA class	Age	Sex	Comorbidities	Abnormal results on relevant tests	Referred for specialist assessment	Change of management	Clinical adverse event
1	52	F	None	No	No	No	Bradycardia
1	76	M	None	No	No	No	Hypertension
2	45	M	None	No	No	No	Hypertension
2	59	M	Diabetes mellitus	No	Yes (endocrinology – fasting blood glucose = 186)	Yes	Hyperglycaemia
2	61	M	None	No	No	No	Bradycardia
2	62	M	None	No	No	No	Bradycardia
2	68	F	Systemic arterial hypertension, diabetes mellitus	No	No	No	Hypertension
2	70	M	Systemic arterial hypertension	No	Cardiology	No	Cerebrovascular accident
2	78	M	Systemic arterial hypertension, diabetes mellitus, chronic renal insufficiency	Creatinine = 2.2	No	No	Hypertension
2	81	F	Diabetes mellitus, hypothyroidism	No	Yes (because of results of ECG and chest radiography; specialty not recorded)	Yes	Bronchospasm
2	81	M	Systemic arterial hypertension	No	No	No	Bronchospasm
2	82	F	None	No	No	No	Acute MI
2	85	F	Systemic arterial hypertension	No	No	No	Bradycardia

Turnbull and Buck15 sought to assess the clinical value of routine pre-operative screening in otherwise healthy patients undergoing cholecystectomy. They reported the number of patients with abnormal results, the number of patients with abnormal results who received clinical interventions consequent on those results and the number of patients who developed a complication relevant to a test – in other words, a complication of which the test was intended to predict an increased risk. Thus, perioperative hypotension or a post-operative Hb concentration < 10.0 g/dl were deemed to be complications relevant to low Hb. The complications relevant to low white blood cell counts were not specified and high white cell counts were not reported as abnormal because of the possibility that they were caused by the patient’s cholecystitis. 15

A total of 1005 complete blood cell counts were undertaken in 1010 patients, but only eight tests were reported as having abnormal results; assuming that each test was undertaken in a different patient, this indicates a rate of 0.8% (95% CI 0.3% to 1.4%). Seven patients had low Hb concentrations (the lowest being 9.9 g/dl); one had a low white cell count (3200/mm³). Action was taken only in relation to two of the patients with low Hb concentrations [assuming that each test was undertaken in a different patient, this represents a rate of 0.2% (95% CI –0.1% to 0.5%)]. These two patients received pre-operative blood transfusions; despite this, one developed a relevant complication, as did one of the five patients with low Hb who did not receive a transfusion. Rates of relevant complications were therefore substantially higher in patients with abnormal Hb (2/7, 28.6%; 95% CI –4.9% to 62.0%) than in those with normal Hb, 14 of whom had relevant complications [assuming that each test was undertaken in a different patient, the denominator is 998, representing a rate of 1.4% (95% CI 0.7% to 2.1%)]. The one patient with a low white blood cell count did not suffer a relevant complication, although such complications were noted in 110 patients with a normal white blood cell count [assuming that each test was undertaken in a different patient, the denominator is 1004, representing a rate of 11.0% (95% CI 9.0% to 12.9%)] (see Appendix 7, Table 29). One patient died as a result of a post-operative pulmonary embolus.

The evidence relating to the value of routine pre-operative FBCs for ASA grade 1 or 2 patients undergoing elective minor to intermediate surgery is limited in both quantity and quality, as it is derived from five observational studies: data are available for a total of 1982 patients in ASA grades 1–2 (or equivalent) from the studies by Gnocchi et al. ,11 Haug and Reifeis,13 Szmuk et al. 9 and Turnbull and Buck,15 and a further unspecified number from the study by Tallo et al. 12

As may be seen from the summary in Table 5, this limited evidence suggests that the proportion of patients with an abnormal result in any component of the full blood test is low (range 0.8–3.0%), and the proportion with both an abnormal test result and a consequent change in clinical management is lower (range 0–1.9%). No deaths were specifically reported in patients with abnormal test results; Turnbull and Buck15 reported that one patient died as a consequence of a post-operative pulmonary embolus, but did not state whether or not this patient had an abnormal result on any test.

TABLE 5 - Abnormal FBC results and their consequences in ASA grade 1–2 (or equivalent) patients undergoing routine pre-operative testing

N/A, not available.

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Assuming all 300 patients underwent this test.

Number of tests performed in 1010 patients.

Number of abnormal tests.

Blood transfusion.

One borderline low, two elevated (the latter two both in patients being treated for dentoalveolar abscesses).

Study	Number of patients tested	Definition of abnormal result	Number of patients with abnormal results (%; 95% CI)	Number of patients with operation postponed or cancelled because of test result (%; 95% CI)	Number of patients with other change in management because of test result (%)	Number of patients with abnormal test result and related adverse event (%)	Number of deaths in patients with abnormal test result (%)
Any component of FBC
Gnocchi et al. 200011	214	N/A	Not reported	4/214 (1.9%; 0.1% to 3.7%)	0	0	0
Haug and Reifeis 199913	380	N/A	7/380 (1.8%; 0.5% to 3.2%)	0	0	Not reported; implicitly none	Not reported; implicitly none
Szmuk et al. 20029	300	N/A	9 (3.0%; 1.1% to 4.9%)a	0	Not reported	Not reported; implicitly none	Not reported; implicitly none
Tallo et al. 200712	Not clear	N/A	Not reported	Not reported	Not reported	0	0
Turnbull and Buck 198715	1005b	N/A	8c (0.8%; 0.3% to 1.4%)	0	2d (0.2%; –0.1% to 0.5%)	0	0
Individual components of FBC
Hb
Gnocchi et al. 200011	214	< 8 g/dl	Not reported	4/214 (1.9%; 0.1% to 3.7%)	0	0	0
Haug and Reifeis 199913	380	Not specified	3/380 (0.8%; –0.1 to 1.7%)	0	0	Not reported; implicitly none	Not reported; implicitly none
Szmuk et al. 20029	Records of 300 patients examined. Not clear how many underwent each test	< 12 g/dl	9 (3.0%; 1.1% to 4.9%)a	0	Not reported	Not reported; implicitly none	Not reported; implicitly none
Tallo et al. 200712	Not clear	Men < 14 mg/dl; women < 12 mg/dl	Not reported	Not reported	Not reported	0	0
Turnbull and Buck 198715	1005b	Implicitly < 10.0 g/dl	7c (0.7%; 0.2% to 1.2%)	0	2d (0.2%; –0.1% to 0.5%)	0	0
Haematocrit
Haug and Reifeis 199913	380	Not specified	1/380 (0.3%; –0.3% to 0.8%)	0	0	Not reported; implicitly none	Not reported; implicitly none
Tallo et al. 200712	Not clear	Not specified	Not reported	Not reported	Not reported	0	0
Platelet count
Turnbull and Buck 198715	1005b	Abnormal according to ‘generally accepted laboratory standards’	0	N/A	N/A	N/A	N/A
White blood cell count
Haug and Reifeis 199913	380	Not specified	3/380e (0.8%; –0.1% to 1.7%)	0	0	Not reported; implicitly none	Not reported; implicitly none
Turnbull and Buck 198715	1005b	Abnormal according to ‘generally accepted laboratory standards’	1 (0.1%; –0.1% to 1.3%)	0	1 (0.1%; –0.1% to 1.3%)	0	0

Electrolytes and renal function (U&Es)

Four studies9,11,12,15 evaluated the use of tests for electrolytes and renal function. Three of these9,12,15 assessed such tests in all patients included in the study. However, Gnocchi et al. 11 limited routine testing for creatinine to the unspecified number of ASA grade 1 patients in their study who were aged ≥ 60 years; no abnormal results were found in this group.

In the study by Szmuk et al. ,9 no patients were said to have abnormal sodium, potassium or creatinine levels. Two patients were found to have slightly high urea nitrogen levels (45–48 mg); these were attributed to mild dehydration which, in both cases, was consonant with the case history or physical examination. As both patients had creatinine levels which were considered normal, with no evidence of any kidney damage, their operations were not cancelled or postponed as a consequence of the abnormal urea nitrogen results.

In the study by Tallo et al. ,12 only one patient in ASA grade 1 or 2 suffered a relevant adverse clinical event and had an abnormal U&E result. This was a 78-year-old male with hypertension, diabetes mellitus and chronic renal insufficiency; he had an abnormal creatinine result which had not triggered a specialist referral or a change of clinical management (Table 6).

TABLE 6 - Abnormal U&E results and their consequences in ASA grade 1–2 (or equivalent) patients undergoing routine pre-operative testing

N/A, not available.

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Only patients aged ≥ 60 years were tested.

Assuming all 300 patients underwent this test.

Hypertension in patient with creatinine of 2.2.

Number of pre-operative tests.

Potassium was given pre-operatively.

Post-operative hypokalaemia in a patient who was supplemented pre-operatively with potassium.

Study	Number of patients tested	Definition of abnormal result	Number of patients with abnormal results (%; 95% CI)	Number of patients with operation postponed or cancelled because of test result (%; 95% CI)	Number of patients with other change in management because of test result (%)	Number of patients with abnormal test result and related adverse event (%)	Number of deaths in patients with abnormal test result (%)
Any component of U&E
Gnocchi et al. 200011	Not cleara	Test was for creatinine only; no definition of abnormal result given	0	N/A	N/A	N/A	0
Szmuk et al. 20029	300b	N/A	2 (0.7%; –0.3% to 1.6%)	0	Not reported	Not reported; implicitly none	Not reported; implicitly none
Tallo et al. 200712	Not clear	N/A	Not reported	Not reported	Not reported	1c	0
Turnbull and Buck 198715	995d	N/A	Not reported	Not reported	Not reported	Not reported	0
Individual components of U&E
Sodium
Tallo et al. 200712	Not clear	< 135 or > 145 mmol/l	Not reported	Not reported	Not reported	0	0
Turnbull and Buck 198715	995d	Abnormal according to ‘generally accepted laboratory standards’	5 (0.5%; 0.06% to 0.9%)	0	0	Not reported	0
Potassium
Tallo et al. 200712	Not clear	< 3.2 or > 5.0 mmol/l	Not reported	Not reported	Not reported	0	0
Turnbull and Buck 198715	995d	Abnormal according to ‘generally accepted laboratory standards’	14 (1.4%; 0.7% to 2.1%)	Not reported	4/995e (0.4%; 0.01% to 0.8%)	1/995f (0.1%; –0.1% to 0.3%)	0
Urea nitrogen
Szmuk et al. 20029	300a	< 45 mg	2 (0. 7%; –0.3% to 1.6%)	0	Not reported	Implicitly none	Implicitly none
Turnbull and Buck 198715	995d	Abnormal according to ‘generally accepted laboratory standards’	1 (0.1%; –0.1% to 0.3%)	0	0	0	0
Creatinine
Gnocchi et al. 200011	Not clearb	None given	0	N/A	N/A	N/A	0
Tallo et al. 200712	Not clear	> 1.0 mg/dl	Not reported	Not reported	Not reported	1c	0
Turnbull and Buck 198715	995d	Abnormal according to ‘generally accepted laboratory standards’	2 (0.2%; –0.1% to 0.5%)	0	0	0	0

Turnbull and Buck15 reported that 995 multiphasic screening tests (Sequential Multiple Analysis-12) were undertaken in 1010 patients (Table 7). Although 14 patients were said to have abnormally low potassium levels, the definition of ‘abnormal’ is not provided and only three were said to be outside ‘the traditionally accepted surgical and anaesthetic limits of 3.2 to 5.8 mEq/l (3.2 to 5.8 mmol/dl)’; the lowest value was 3.1 mmol/l. Four of the 14 patients received pre-operative supplementation with potassium; despite this, one of the four suffered post-operative hypokalaemia. None of the patients with low potassium suffered a cardiac complication. Two patients had clinically significantly elevated creatinine (1.8 and 3.2 mg/dl), but no consequent modification of surgical or anaesthetic management was recorded, and there were no relevant complications. Five tests showed abnormal sodium results and one patient had an abnormal urea level, but these abnormalities were said not to be clinically significant. For details, see Appendix 7, Table 30.

TABLE 7 - Vasovagal reactions in patients undergoing venepuncture in outpatient settings16

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Complication	Number (%; 95% CI)
Diaphoresis, near syncope	105/4050 (2.6%; 2.1% to 3.1%)
Syncope	24/4050 (0.6%; 0.4% to 0.8%)
Convulsive syncope	6/4050 (0.1%; 0.03% to 0.3%)
Ventricular tachycardia	1/4050 (0.02%; 0% to 0.1%)
Total	136/4050 (3.4%; 2.8% to 3.9%)

The evidence relating to the value of routine U&Es for ASA grade 1 or 2 patients undergoing elective minor to intermediate surgery is limited in both quantity and quality, being derived from only four observational studies: data are available for a total of 1310 patients in ASA grade 1–2 (or equivalent) from the studies by Szmuk et al. 9 and Turnbull and Buck,15 and a further unspecified number from the studies by Gnocchi et al. 11 and Tallo et al. 12

As may be seen from Table 6, only one study, that by Szmuk et al. ,9 reported the proportion of patients with an abnormal result in any component of the test; this figure was low, at 0.7%, and did not lead to any change in clinical management. No deaths were specifically reported in patients with abnormal test results although, as previously noted, Turnbull and Buck15 reported that one patient died as a consequence of a post-operative pulmonary embolus, but did not state whether or not this patient had an abnormal result on any test.

Venepuncture: adverse events

Blood samples for FBCs and U&Es are obtained by venepuncture. As none of the included studies reported adverse events relating to this process, additional systematic searches were carried out which were designed to identify studies of adverse events in adults who:

• were comparable in terms of health status with the population included in the review of the clinical effectiveness of routine pre-operative testing [in other words, who either were stated to be ASA grade 1 or 2 or were said to be generally healthy, with no underlying medical conditions or medications (such as anticoagulants) which might influence the incidence of adverse events]; and

• were undergoing simple venepuncture for diagnostic or screening purposes (see Appendix 8).

Studies which related to blood donors were excluded because:

• the withdrawal of larger volumes of blood makes it difficult to differentiate between vasovagal reactions and transient relative hypotension due to blood loss16

• the use of needles with a larger bore than the 20–22 gauge generally used in blood sampling may increase the risk of injury. 17

Studies were also excluded if they used more invasive methods of blood collection (cannulation or catheterisation), or collected arterial or capillary rather than venous blood samples.

Case series or case reports were included only if they related to adverse events for which data were not available from larger, higher-quality studies (observational or before-and-after studies).

The searches identified eight relevant articles:

• Observational studies by Galena16 and Deacon and Abramowitz. 18

• An uncontrolled before-and-after study by Godwin et al. 19

• Case reports by Nouri et al. ,20 Pradhan and Gupta,21 Saeed and Gatens,4 Sander et al. 22 and Zubairy23 [for quality of reporting of meta-analyses (QUOROM) diagram, see Appendix 9].

• Three additional relevant articles, by Berry and Wallis,24 Horowitz,17 and Yuan and Cohen,25 were identified from citations.

The adverse events identified by these articles fall into three categories:

• vasovagal reactions

• pain and bruising

• more serious nerve injury.

These adverse events are discussed in turn below.

Vasovagal reactions

Vasovagal reactions result from an abnormal reflex stimulation of the vagus nerve. The trigger factors may be emotional or somatic. 26 In most patients, the signs and symptoms (which may include pallor, sweating, nausea, dizziness or light-headedness) are light or moderate and resolve spontaneously. However, some patients experience bradycardia with consequent hypotension, loss of consciousness and, in very severe cases, death. 26

Because data relating to vasovagal reactions are available from two large observational studies,16,18 lower-quality studies (case reports and small case series) relating to such adverse events have been excluded.

The larger observational study, that by Galena,16 recorded adverse effects associated with venepuncture carried out in outpatient settings between October 1988 and April 1991 on 4050 patients who were applying for life insurance. A 20- or 22-gauge needle was used to obtain a maximum of 30 μl of blood from each patient. Delayed reactions were identified using telephone calls made an unspecified length of time after the venepuncture. Potentially serious vasovagal reactions were experienced by 3.4% of patients (Table 7); these were significantly more common in men than in women (4.0% vs 1.3%; p < 0.001). None of those who experienced convulsive syncope had a previous history of seizure disorder.

Deacon and Abramowitz18 found lower rates of vasovagal reactions in 3315 adults undergoing venepuncture in three hospital outpatient phlebotomy clinics over a 3-week period, even though 80% had fasted prior to their venepuncture (Table 8). Although the rate indicated by the phlebotomists was higher, at 0.9%, than that reported by the patients, it was still substantially lower than the rate of 3.4% reported by Galena. 16

TABLE 8 - Vasovagal reactions in patients undergoing venepuncture in hospital phlebotomy clinics18

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

For example, reclining the patient’s chair, asking patients to place their heads between their legs, or using a cold towel.

Complication	Number (%; 95% CI)
Patient reported feeling very or extremely faint	13/3315 (0.4%; 0.2% to 0.6%)
Patient reported losing consciousness	7/3315 (0.2%; 0.1% to 0.4%)
Phlebotomist reported using strategies to manage fainting symptomsa with patient	30/3315 (0.9%; 0.6% to 1.2%)

Pain and bruising

Because data relating to pain and bruising are available from one large observational study16 and one uncontrolled before-and-after study,19 lower-quality studies (case reports and small case series) relating to such adverse events have been excluded.

In Galena’s large observational study,16 14.2% of patients reported adverse events related to pain and bruising (Table 9). Such adverse effects were significantly more common in women than in men (38.1% vs 7.9%; p < 0.001), a result which Galena16 suggested was probably related to narrower veins in women. No cases of local cellulitis or phlebitis were reported.

TABLE 9 - Pain and bruising in patients undergoing venepuncture in outpatient settings16

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Complication	Number (%; 95% CI)
Bruising	416/4050 (10.3%; 9.3% to 11.2%)
Haematoma	80/4050 (2.0%; 1.6% to 2.4%)
Pain	80/4050 (2.0%; 1.6% to 2.4%)
Total	576/4050 (14.2%;, 13.1% to 15.3%)

Godwin et al. 19 reported higher overall rates of bruising. This small before-and-after study audited bruising in two groups of 100 consecutive medical and surgical inpatients aged ≥ 15 years who were not receiving anticoagulants and did not have extensive pre-existing bruises. Venepuncture was performed by phlebotomists using a pre-evacuated tube collection system to take blood from the antecubital fossa. A clean cotton wool ball was then taped to the venepuncture site; the phlebotomist instructed patients in the first group to apply pressure for a few minutes after the venepuncture, but remained with patients in the second group until the bleeding had stopped. The venepuncture site was then assessed 24 hours later. Bruising was less common in the second group (45% vs 25%; p < 0.01), and such bruises as occurred were also smaller in this group. The difference between the groups was more marked in older patients (Table 10) and the investigators suggested that this was perhaps because they were less able than younger patients to apply pressure to the venepuncture site. 19

TABLE 10 - Bruising after venepuncture, by haemostasis technique and patient age19

Data in Roman font were taken directly from the text; data in italics were calculated by the reviewer.

Patient age (years)	Number of patients with bruising (%; 95% CI)
	Patient pressure	Phlebotomist pressure
< 60	11/37 (30%; 15% to 44%)	7/42 (17%; 5% to 28%)
> 60	34/63 (54%; 42% to 66%)	18/58 (31%; 19% to 43%)
Total	45/100 (45%; 35% to 55%)	25/100 (25%; 17% to 33%)

Nerve injury

The potentially most serious adverse events associated with venepuncture relate to nerve injury. Such adverse events can have disabling consequences. The only identified publications that report venepuncture-associated nerve injuries sufficiently severe to be brought to medical attention take the form of case reports and one small case series.

The case series presented data relating to 11 patients who were referred to a specialist with a particular interest in nerve injuries because of causalgia following routine venepuncture. 17 However, only four of these patients had undergone venepuncture for blood sampling; in the remainder, the venepuncture was for blood donation, insertion of intravenous lines or intravenous medication. A later paper by Horowitz5 combined data relating to these 11 patients with data from 13 patients who had subsequently been evaluated; this could not be utilised because it presented aggregated data from patients who had undergone venepuncture for blood sampling and patients who had undergone venepuncture for other reasons.

Data relating to the cases identified in the case reports, together with the four relevant patients from Horowitz’s case series,17 are summarised in Table 11. They demonstrate that nerve damage consequent on venepuncture can cause long-lasting pain, loss of muscle power and manual dexterity, and may also lead to clinical depression. Two studies specifically stated that a 20-gauge needle was used. In 4 of the 11 cases, venepuncture was specifically said to have been difficult.

TABLE 11 - Nerve damage associated with venepuncture

Study	Subject	Purpose and site of venepuncture	Diagnosis	Outcome	Comment
Berry and Wallis 197724	50-year-old woman	Blood grouping; left antecubital fossa	Injury to the medial cutaneous nerve	Pain and swelling in the forearm developed within 24 hours into hyperaesthesia in the whole forearm. A striking improvement was noted 24 hours after treatment with carbamazepine and 3 days later the only symptom was slight pain on moving the arm. Treatment was discontinued after 5 weeks, when the patient had no symptoms except slightly impaired touch sensation in the sensory distribution of the left medial cutaneous nerve	20-gauge needle used
Horowitz 199417	61-year-old woman	Blood sampling; antecubital fossa	Causalgia affecting medial antebrachial cutaneous nerve	Increased symptoms and motor abnormalities of disuse, with joint contracture and psychiatric depression requiring antidepressant medication, observed at 7 years
Horowitz 199417	61-year-old man	Blood sampling; antecubital fossa	Causalgia affecting lateral antebrachial cutaneous nerve	Increased symptoms and motor abnormalities of disuse, with joint contracture and psychiatric depression requiring antidepressant medication, observed at 4 years
Horowitz 199417	56-year-old woman	Blood sampling; antecubital fossa	Causalgia affecting medial antebrachial cutaneous nerve	Increased symptoms, with joint contracture and motor abnormalities of disuse, observed at 18 months
Horowitz 199417	35-year-old man	Blood sampling; wrist	Causalgia affecting superficial radial nerve	The burning pain resolved spontaneously over a 2-week period, but hyperpathia and allodynia in the injured nerve distribution persisted at 2.5 years
Nouri et al. 200020	59-year-old woman	Routine phlebotomy for pre-operative assessment; radial vein	Causalgia affecting radial nerve	Immediate acute pain and numbness; dysaesthesia, hyperaesthesia, allodynia and loss of muscular power still persisted a year later. Following treatment with paroxetine, tramadol and capsaicin (Zacin®, Cephalon) and six nerve blocks, the pain in the arm and forearm was almost completely resolved, and that in the hand and wrist was somewhat reduced	20-gauge needle used. Venepuncture said to be difficult, requiring three attempts
Pradhan and Gupta 199521	32-year-old woman with a minor pyrexial illness	Routine blood testing; cubital vein	Median nerve	Immediate intense pain in whole of left arm persisting on the palmar aspect of the forearm and hand, and accompanied by weakness and tingling. The paraesthesia subsided in 2 months; mild anaesthesia in radial side of palm persisted for 4 months; muscle power returned to normal with physiotherapy, but minimal wasting was still observed after 1 year	Venepuncture said to be very difficult because of non-visibility of veins
Saeed and Gatens 19834	47-year-old man	Pre-operative phlebotomy; cubital vein	Anterior interosseous syndrome	Pain in forearm and inability to flex thumb noted 4 days after surgery. Surgical tendon transfer required 14 months later to enable appropriate movement of the thumb	Venepuncture said to have been very difficult
Sander et al. 199822	64-year-old woman	Phlebotomy (purpose not stated); antecubital	Lateral antebrachial cutaneous neuropathy	Acute pain on insertion of needle followed by pain and numbness persisting, with some improvement, for 5 months
Yuan and Cohen 198525	31-year-old man	Routine phlebotomy for pre-operative blood tests; cubital vein	Laceration of the lateral antebrachial cutaneous nerve with neuroma formation	Excruciating pain followed by numbness noted during venepuncture, followed by pain and numbness in the forearm persisting for 3 weeks, and resistant to treatment with butazolidin; lidocaine and steroid injection did not produce lasting relief. Surgery was performed on two occasions: the first was ineffective; the second relieved the pain but left permanent numbness. However, motor function was unimpaired	Repeated attempts at venepuncture were required
Zubairy 200223	44-year-old woman	Routine post-operative blood sampling; cubital fossa	Severe anterior interosseus nerve lesion	Loss of function in the thumb and index finger; weakness of pronation. Management was conservative. The first sign of spontaneous recovery was observed at 20 months and normal function at 34 months after the injury

The case studies summarised above do not provide any indication of the rate of incidence of nerve injuries related to venepuncture, other than to imply that they were rare. A more specific impression of the incidence rate can be obtained only by considering two studies from blood transfusion centres. In a New Zealand blood transfusion unit performing approximately 80,000 venepunctures a year, Berry and Wallis24 found that, over a 2-year period, six people suffered injuries to the median nerve or medial and lateral cutaneous nerves which were severe enough for them to seek medical attention – an overall rate of approximately 1 in 25,000 (0.004%). Of those six, only one (noted above) was undergoing venepuncture for diagnostic purposes, using a 20-gauge needle; the remaining five were undergoing venepuncture for blood donation, using a larger 16-gauge needle. As this study gave no indication of the number or proportion of venepunctures undertaken for purposes of diagnosis rather than blood donation, it has not been possible to calculate a rate of nerve injury specific to diagnostic venepuncture; however, it seems likely that it would be lower than the overall rate.

A higher nerve injury rate was reported from a blood donation centre in the USA where nurses routinely reported all donor injuries. Over a 2-year period, 419,000 blood donations were collected using a 16-gauge needle and 66 cases of neurological nerve injury were identified from nursing records – a rate of 1 in 6300 (0.016%). 27 This figure is not directly comparable with the New Zealand figure because it includes cases which were not brought to medical attention, but the data for donors who requested a physician consultation (17 of the 56 individuals with nerve injury for whom follow-up data were available) also indicates a rate of approximately 1 in 25,000 (0.004%) (Table 12). This is a conservative estimate: 9 of the 66 donors with nerve injury could not be contacted for telephone follow-up and one was deliberately not contacted because of pending litigation. 27

TABLE 12 - Number of blood donors with nerve injury following venepuncture (data from Newman and Waxman27)

Mild localised numbness which did not interfere with function.

Data in italics were calculated by the reviewer.

Recovery period	Number of donors with nerve injury and follow-up data (n = 56) (% of total; 95% CI)	Number requesting physician consultation(s) (% of category, 95% CI)	Number with residual neurological defecta (% of category, 95% CI)
< 3 days	22 (39%; 27% to 52%)	0 (0%)	0 (0%)
3–29 days	17 (30%; 18% to 42%)	5 (29%; 8% to 51%)	0 (0%)
1–3 months	13 (4%; 0% to 8%)	8 (62%; 35% to 88%)	2 (15%; 0% to 35%)
3–6 months	2 (23%; 12% to 34%)	2 (100%)	1 (50%; 0% to 100%)
> 6 months	2 (23%; 12% to 34%)	2 (100%)	1 (50%; 0% to 100%)

In relation to the more common adverse effects associated with venepuncture undertaken for diagnostic or screening purposes in healthy patients, the evidence base is arguably more substantial than that relating to the value of routine pre-operative testing. Vasovagal reactions were reported by two large observational studies, by Galena16 and Deacon and Abramowitz;18 these included 7365 individuals. Data relating to pain and bruising from 4250 patients were available from Galena’s large observational study16 and a small before-and-after study by Godwin. 19 Unfortunately, data relating to nerve injuries in patients specifically undergoing venepuncture for diagnostic or screening purposes were available only from case series or case reports.

The adverse events which were most commonly reported were those related to pain and bruising: these affected between 14% and 45% of patients. Vasovagal reactions were rarer, affecting between 0.9% and 3.4%. No incidence data are available relating to nerve injuries; although these injuries are potentially disabling, they appear to be rare, and it seems likely that the incidence rate would be lower than the 0.004% reported in blood donors.

Pulmonary function testing

Only one study, the pseudo-RCT of pre- and post-operative breathing exercises by Roukema et al. ,14 provided evidence relating to the benefits of PFTs (Table 13). Four of the 84 patients in the control group (4.8%; 95% CI 0.2% to 9.3%) had an abnormal result, defined as a vital capacity < 75% of normal; these patients also had an abnormal forced expiratory volume in 1 second (FEV₁). Only two of the four patients (50.0%; 95% CI 1.0% to 99.0%) subsequently experienced post-operative pulmonary complications, compared with 48 of the 80 patients with normal vital capacities (60.0%; 95% CI 49.3% to 70.7%), and the investigators therefore concluded that pre-operative PFT had no predictive value.

TABLE 13 - Abnormal PFT results and their consequences in ASA grade 1–2 (or equivalent) patients undergoing routine pre-operative testinga

Data in italics were calculated by the reviewer.

Study	Number of patients tested	Definition of abnormal result	Number of patients with abnormal results (%; 95% CI)	Number of patients whose operation postponed or cancelled because of test result (%)	Number of patients with abnormal test result who had a related adverse event (%; 95% CI)	Number of deaths (%)
Roukema et al. 198814	84	Vital capacity < 75% of normal	4/84 (4.8%; 0.2% to 9.3%)	None reported	2/4 (50%; 1% to 99%)	0

The evidence relating to the value of routine PFTs for ASA grade 1 or 2 patients undergoing elective minor to intermediate surgery is extremely limited, being restricted to 84 patients in the control arm of a RCT conducted for another purpose. 14 The proportion of patients with an abnormal result was relatively low, at 4.8%, and did not lead to a change in management in any of the patients.

As the included study did not report adverse events relating to PFTs and the clinical effectiveness searches identified only one relevant case report,28 additional systematic searches were carried out; these were designed specifically to identify studies which reported adverse events associated with PFTs in patients without obvious predisposing health conditions (for the MEDLINE search strategy, see Appendix 8). These additional searches identified two relevant articles, by Krasnick29 and Oliphant et al. 30 (for QUOROM diagram, see Appendix 10); a further three relevant articles, by Manço et al. ,31 Nemet et al. 32 and Varkey and Cory,33 were identified from citations. A seventh paper, reporting a case of short-lived pneumoparotid apparently caused by PFTs, was excluded because the patient had a predisposition to this condition: he could sometimes produce facial swelling intentionally by coughing or blowing forcefully against his closed mouth, and had had bilateral facial swelling after an aeroplane flight. 34

Krasnick29 states that the adverse effects of PFTs include dizziness from hyperventilation and vasovagal reactions. However, such adverse events were not reported in the included studies, which reported only potentially more serious adverse events which appeared to be related to increased pressure in the mouth, throat or chest: pneumomediastinum, pneumothorax, subcutaneous emphysema and incarceration of existing inguinal hernia. One study30 reported an adverse event of a different nature, namely bilateral temporomandibular joint dislocation. The authors noted that, to the best of the their knowledge, this was unique as an adverse effect of PFT: most such dislocations result from wide opening of the mouth, which is not required for PFT (Table 14).

TABLE 14 - Pulmonary function testing: adverse events in subjects without obvious predisposing health conditions

FVC, forced vital capacity.

Study	Subject	Specific test used	Adverse event	Treatment	Resolution
Krasnick 200129	32-year-old man with upper-chest tightness	Investigational spirometry before and after administration of nebulised levalbuterol hydrochloride	Pneumomediastinum (symptoms severe throat and neck pain and raised vocal pitch)	Apparently none	Symptoms resolved within 36 hours; a chest radiograph 5 days later was normal
Nemet et al. 200432	Healthy 22-year-old, non-smoking female volunteer	Repeated FEV1s performed ‘with great vigour’ as part of research study	Pneumomediastinum and subcutaneous emphysema	Admitted to hospital overnight and treated with supplemental oxygen	Condition had improved sufficiently by the following day for hospital discharge; a full recovery was made within 2 weeks
Manço et al. 199031	Healthy 25-year-old, non-smoking male physician	Standard spirometry, including repeated measurement of PEmax, undertaken as part of investigation to establish normal values	Pneumomediastinum, bilateral pneumothorax and subcutaneous emphysema (symptoms discomfort in the neck, mild dysphagia and dysphonia)	Apparently none	Symptoms resolved in about 3 days
Varkey and Kory 197333	Healthy 23-year-old male medical student	FVC undertaken for familiarisation with PFT procedures	Mediastinal and subcutaneous emphysema (symptoms anterior chest pain, dizziness, swollen neck and mild discomfort on swallowing)	Hospital admission for observation, symptomatic treatment for pain	Symptoms subsided completely in the following 5 days
Patel et al. 199228	Two male patients (one aged 63 and one aged 80 years) with inguinal hernia	Pre-operative PFT	Incarceration of existing inguinal hernia	Emergency surgery	Uncomplicated recovery; discharged from hospital on the fifth and fourth post-operative day
Oliphant et al. 200830	78-year-old man	PFT (purpose not specified)	Bilateral temporomandibular joint dislocation	Supplemental oxygen via nasal cannula; reduction of dislocation under conscious sedation	Discharged with follow-up arranged with a maxillofacial surgeon; PFT repeated uneventfully 6 weeks later

The studies summarised above provide little indication of the rate of incidence of adverse events related to PFTs. Four29,30,32,33 of the six studies were individual case reports; as such, they provide no estimate of the incidence of the adverse events which they report other than to imply that, in the authors’ experience, they were unusual. Manço et al. 31 reported that pneumomediastinum, bilateral pneumothorax and subcutaneous emphysema occurred in 1 of 30 normal subjects in whom repeated measurement of maximum static expiratory (PE_max) mouth pressure had been undertaken for research purposes; the remaining 29 subjects suffered no ill effects. However, it seems highly unlikely that the incidence of this complication in normal clinical practice is as high as 1 in 30 as the authors stated that they had not previously observed any complications during extensive use of the technique in normal subjects and patients. 31 Moreover, it is perhaps noteworthy that the subjects of two other case reports were volunteers undertaking PFT for purposes of research32 or familiarisation:33 they are likely to have performed the manoeuvres more frequently or more vigorously than would be normal in pre-operative testing. Following their observation that two patients with inguinal hernia developed incarceration in that hernia following routine pre-operative PFT, apparently as a result of the prolonged increase in intra-abdominal pressure caused by forced expiratory spirometry, Patel et al. 28 undertook a retrospective review which identified that the remaining six patients with inguinal hernia who were referred for pre-operative spirometry in the same hospital during the same 12-month period did not suffer this adverse event, suggesting an incidence rate of one in four in this particular patient group. They identified no clinical or physiological criteria which differentiated the patients who developed incarceration from those who did not, and therefore concluded that, to prevent this complication, the use of a truss should be considered when undertaking PFT in all male patients with hernias.

Only one of the six studies, that by Patel et al. ,28 specifically stated that the adverse effects occurred after routine pre-operative PFT. In the case report by Oliphant et al. ,30 the purpose of testing was not clear, while in the case reported by Krasnick29 it was carried out for investigational purposes. In the remaining three cases, PFT was carried out either for research purposes31,32 or for familiarisation with the process;33 it is possible therefore that they were not representative of patients undergoing PFT for routine pre-operative testing. Thus, in the case reported by Manço et al. ,31 repeated measurement of PE_max mouth pressure was performed in an exercise designed to establish normal values for that laboratory, while Nemet et al. 32 reported that the subject performed FEV₁ manoeuvres ‘with great vigour’, perhaps implicitly greater than usual in clinical practice, and to have continued despite feeling chest pain after the first FEV₁ manoeuvre; she did not report this pain, but ran on a treadmill for 10 minutes before repeating the FEV₁ manoeuvre twice more, by which time the symptoms had increased. Finally, Varkey and Kory33 reported the case of a healthy 23-year-old male medical student, described as ‘most eager to perform as well as possible on the pulmonary function tests’, who also continued with the tests despite noticing slight chest pain after the first manoeuvre, and increasing symptoms thereafter. It thus appears possible that, in these three cases, the symptoms may have been caused by particularly energetic performance of the manoeuvres, and exacerbated by continuation with testing despite the existence of those symptoms; such scenarios may not be typical of routine patient testing.

Chapter 3 Cost-effectiveness

Results

Literature search results

Figure 2 shows the results of the literature search which identified 5151 references in total. Of these, there were 252 duplicated references. Thirty-two references were identified as not being in the English language. Non-English-language references were identified electronically by scanning through the database entries. Two hundred and eighty-two references were identified as relevant from the title and abstract sifting using the abstract selection criteria. Of the 282 full manuscripts that were obtained for further assessment, eight papers36–43 (one full economic evaluation36 and seven partial economic evaluations37–43) were identified for data extraction.

FIGURE 2.

Results of cost-effectiveness literature search.

Full papers excluded

All 282 full papers that were identified as relevant were assessed based on the abstract selection criteria. An abstract selection table was used to log the key characteristic of each paper. Papers were excluded from further detailed assessment and data extraction if they did not fit the inclusion criteria. For example, papers were not included if they were not in the English language or were of studies not carried out in the UK or that did not assess the relevant pre-operative tests. The result of the full paper screening based on the 282 references identified is given in Table 15. Manuscripts were excluded if they did not fit one or more of the inclusion criteria. (Characteristics of all the 282 full papers in relation the abstract selection criteria are presented in Appendix 12. )

TABLE 15 - Results of full paper screening against the abstract selection criteria

Stages		No. of references identified
Manuscripts obtained for more detailed appraisal after title and abstract screening		282
Manuscripts excluded from data extraction
Language – not English	39
Patients 1 – not aged 16–60 years	17
Surgical procedures – not minor or intermediate	1
Tests – not FBC, U&E or PFT	12
Economic evaluation: not incremental analysis of costs and outcomes and not
Patients 2 – not ASA grade 1 or 2 classification, or
Surgical procedures – not minor or intermediate, or
Tests – not FBC, U&E or PFT	205
Total no. manuscripts excluded from data extraction		274
Manuscripts identified for data extraction		8
Full economic evaluations (i.e. report incremental cost-effectiveness ratio)	1
Partial economic evaluations	7

Two hundred and five papers were excluded because they did not provide a full economic evaluation. This was in addition to not assessing the patient population, surgical procedures and pre-operative tests relevant to the current study. A further 39 papers were found not to be in the English language. Seventeen papers were excluded because they did not assess the age range of patients relevant to this study. A further 13 papers did not meet the criteria for the pre-operative tests and the surgical procedures under study.

Studies identified for inclusion

A final set of eight papers were identified for inclusion in the cost-effectiveness review and data extraction (see Appendix 13 for data extraction tables). On closer inspection of the data relating to the patient ASA grade, surgical interventions and pre-operative tests performed, it became clear that the studies identified did not provide enough relevant data to inform the model structure or parameterisation of the economic model for any of the three tests currently under study (Table 16).

TABLE 16 - Characteristics of the studies identified for the cost-effectiveness review

APEC, Anaesthesia Preoperative Evaluation Clinic; BUN/creat, blood urea nitrogen and creatinine; CBC, complete blood count; Coags, tests of coagulation; CPM, calcium, phosphate and magnesium; DSU, Day Surgery Unit; Elec/Glu, electrolytes and blood glucose; EUC, electrolytes, urea and creatinine; G&H, group and hold test; INPT, inpatient; LFT, liver function test; PAC, pre-admission clinic; Plt/BT, platelet count and bleeding time; PT/PTT, prothrombin time and partial thromboplastin time; T/SA, blood typing and screening for unexpected antibodies; TFT, thyroid function test; UA, urinalysis; UTI, urinary tract infection.

Study	Type of evaluation and synthesis	Type of test	Interventions	Study population	Country	Duration of study	Comments
Full economic evaluations
Lawrence et al. 198936	Full cost-effectiveness and cost–benefit analyses	Routine UA	Use of routine UA in the prevention of wound infection for elective clean-wound, non-prosthetic knee procedures. A comparison of routine, or screening, pre-operative UA vs no screening UA for UTI remote from the operative site	Surgical subset of elective, clean wound, intra-articular, non-prosthetic knee procedures not involving osteotomy	USA	Not stated	Insufficient detail given to assume data was limited to ASA grade 1, or adults
Partial economic evaluations
Capdenat Saint-Martin et al. 199837	Not a full economic evaluation – assessed the number and type of pre-operative tests ordered within the study period, the estimated savings and mean cost of pre-operative testing	T/SA, Hb, PT/PTT, Plt/BT, Elec/Glu and BUN/creat	Local adaptation of national guidelines combined with active feedback and organisational analysis	Anaesthetists in 15 surgical wards of Bordeaux University Hospital, Region Aquitain, France	France	1 month in 1993 and 1 month in 1994	ASA grade 1 patients, but includes children and emergency surgery
Fischer 199638	Not a full economic evaluation – total pre- and post-clinic implementation costs were evaluated to assess the cost saving of the introduction of the clinic	CBC, platelets, UA, PT/PTT, general survey panel, electrolytes, renal panel, CXRs and ECGs	APEC	8972 adult patients attending the APEC who were evaluated for surgery and consultation	USA	6-month period pre-APEC and 1-year post APEC	Includes ASA grade 3 and 4 patients. Not enough detail given to grade of surgery
Imasogie et al. 200339	Not a full economic evaluation – provides an assessment of cost savings when routine pre-operative testing is discontinued	Includes CBC, electrolytes, creatinine, urea, glucose and ECG	The discontinuation of pre-operative tests in ambulatory cataract surgery – two groups compared: (a) testing group with (b) non-testing group	Consecutive cataract patients’ charts were reviewed, during the period of June to September 2000 representing the patients who had routine pre-operative tests (testing group) and June to September 2001 representing the patients who had no routine pre-operative tests (non-testing group)	Canada	4 months	Appears to include any ASA grade
Johnson and Mortimer 200240	Not a full economic evaluation – a cost-saving analysis was presented in terms of the selective ordering of tests	The medical notes of 100 surgical patients were scrutinised pre-operatively prior to induction of anaesthesia The results of FBC, U&Es⁄creatinine and random glucose were recorded	Prospective audit of medical notes of patients undergoing elective surgery	100 patients undergoing elective surgical procedures under general anaesthesia	UK	1995–6	ASA status and surgical intervention not reported
Kitz et al. 198841	Cost analysis – not full economic evaluation, results present include a cost analysis of operating and recovery room time, staff costs and total costs of pre-operative tests in the two study settings	CBC, UA, ECG, Panel 6 and chest radiogram	Inpatient and ambulatory logs were examined to identify hospital resources used for comparable groups of INPTs and DSU patients undergoing surgical arthroscopy and laparoscopy: level I – visual examination of pelvic viscera; level II –also includes fallopian tube with methylene blue or radio-opaque dye	INPTs and DSU patients undergoing surgical arthroscopy of the knee or diagnostic laparoscopy (ASA grade 1 and 2 patients)	USA	January to June 1984	Limited data, only providing a cost summary
Larocque and Maykut 199442	Not a full economic evaluation – provides unit costs of each of the pre-operative tests employed and a count of each time a test was performed which was compared for the pre- and post-protocol period	CBC, liver profile, chest radiography, electrocardiography and UA	Implementation of a guideline for pre-operative laboratory investigation using retrospective chart audit	Patients operated on including minor surgery and major surgery	Canada	December 1991 to July 1992	Included patients ASA grades 3–5 and major surgery
MacPherson et al. 200543	Not a full economic evaluation – the average number of tests per patient and cost of tests per patient were calculated	Coags; CPM; EUC; FBC; G&H; LFT and TFT	Assessment of a protocol-based test ordering system or guideline in the ordering of pathology tests in surgical patients attending PAC	All elective adult surgical patients attending the hospital PAC	Australia	Pre-guideline implementation – Group I (700 individuals attending the PAC between April and June 2002); immediate post-guideline introduction (720 individuals between April and June 2003)	Insufficient detail given to assume data was limited to ASA grade 1, or adults, or grade 1–2 surgery

The Lawrence et al. study36 is the only full economic evaluation identified by the literature search. However, the focus of the study is urinalysis (UA), and it does not report results for any of the tests in the scope of the review.

Capdenat Saint-Martin et al. 37 assessed the use of a local adaptation of national guidelines combined with active feedback and organisational analysis on the ordering of pre-operative investigations for fit ASA grade 1 patients undergoing surgery in 15 wards in a university hospital in France. Pre-operative tests ordered were assessed over 1 month, before and after the local guideline was employed. The sample population included low-risk patients. The patient population included in the study comprised both children aged < 18 years and adults: pre-intervention, n = 536 (47% of the sample were aged < 15 years); post-intervention, n = 516 (50% were aged < 15 years). Given that the data were not split by age group, it is not possible to report the findings for the adult population aged 16–60 years independently.

Pre-operative tests assessed included blood typing and screening for unexpected antibodies, Hb, prothrombin time and partial thromboplastin time, platelet count and bleeding time, electrolytes and blood glucose, blood urea nitrogen and creatinine.

Outcome measures reported in the study included the number and type of pre-operative tests ordered within the study period (1 month in 1993 and 1 month in 1994 representing the pre- and post-guideline time periods) and the estimated savings. Mean costs of pre-operative testing were calculated for the two measurement periods, costs were reported in francs, dollars and the European currency unit (ECU – an artificial ‘basket’ currency that was used by the member states of the European Union as their internal accounting unit at that time).

The study population includes a significant number of patients aged < 15 years. As the current study is concerned with the adult population, this study is not relevant for informing the cost-effectiveness analysis for these tests, as per the scope of the review. The data are presented for the whole sample of patients. There was no subsample analysis that would have enabled the teasing out of data specifically relating to the patient population aged 16–60 years. Additionally, some of the patients underwent emergency surgical procedures. The data for each type of surgery was not presented separately. It was not possible to identify only those patients who had minor or intermediate surgery.

The article by Fischer38 addresses the development and implementation of an Anaesthesia Preoperative Evaluation Clinic (APEC) at a university hospital in the USA. The clinic aimed to provide a service to support physicians in deciding which pre-operative tests their patients might need. All consultations, physical evaluations, educational resources, laboratory and electrocardiographic services, and hospital admissions and registrations were made available in one centralised location. Fischer38 compared pre-operative tests ordered by surgeons and primary care physicians for a 6-month period before the clinic was introduced in the hospital and the 6-month period that occurred 1 year after the introduction of the clinic when ordering of pre-operative assessments was carried out by the anaesthesiologist. Over a 1-year period in 1995, the APEC evaluated 8972 adult patients (age range was not reported) for surgery and consultation. Patient assessments included ASA grade 1 (12%), grade 2 (29%) and grade 3 (54%). Some patients (< 5%) of ASA grade 4 status were also included in the study. Patients evaluated in the clinic were either undergoing surgery the following day (the authors state approximately 70% of the sample) or undergoing procedures 2–7 days after evaluation (28%). No further details are given about the types of surgery that patients underwent.

The pre-operative tests assessed in the study were as follows: complete blood count (CBC), platelets, UA, general survey panel [renal panel, liver function test (LFT), glucose, calcium, albumin, magnesium and uric acid], electrolytes, renal panel and prothrombin time/partial thromboplastin time. These were recorded as the number of each of the tests carried out between the two time periods.

Outcomes assessed in the study included the number of tests ordered, the number of operating room cancellations and number of delays or adverse patient events. The cost of each test was determined using an in-house system. The total pre- and post-clinic implementation costs were evaluated to assess the cost saving resulting from the introduction of the clinic.

The applicability of this evidence is limited for the purposes of this study. A significant number of patients were ASA grade 3 or grade 4 (just under 60%) and thus outside the scope of the review. Additionally, detailed information regarding surgical procedures was not available; thus, we are unable to identify whether procedures undertaken were minor or intermediate. As a result, the relevance of the results of Fischer38 to the patients/procedures specified in the scope of the review is unclear.

The study by Imasogie et al. 39 aimed to evaluate the potential cost savings accruing when routine pre-operative testing is discontinued in ambulatory cataract surgery patients. The hospital-based study was set in Canada and assessed the introduction of a new policy of discontinuing routine laboratory testing prior to cataract surgery.

The charts of cataract patients were reviewed over a 4-month period prior to (testing group) and after the introduction of the new policy a year later. This provided data on 636 patients in the testing group and 595 patients in the non-testing group.

The pre-operative tests assessed included LFT, ECG, echocardiogram, chest radiography, CBC, INR, partial thromboplastin time, Hb, sickle screen, electrolytes, urea and creatinine (EUC); glucose and cardiac stress test.

Clinical data were collected on ASA grade, past medical history and medications, perioperative events (cancellations, intraoperative hypertension, arrhythmia, hypotension), and post-operative events including unanticipated admission and readmissions.

The costs of individual tests were identified from the hospital finance department. Based on the tests ordered and the cost of each, the total costs of laboratory tests of individual patients were calculated. The outcomes evaluated were perioperative hypertension, hypotension, bradycardia arrhythmias, myocardial ischaemia, myocardial infarction, congestive heart failure, syncope, hypoglycaemia, oxygen saturation of < 90% and airway obstruction.

The authors found that there was no difference in the incidence of pre-operative, intraoperative or post-operative events between the two groups of patients. They found a significant reduction in the number of tests per patient ordered in the non-testing group: 0.4 tests per patient compared with 5.8 tests in the testing group. A 90% reduction in laboratory costs per patient was achieved.

Details of patients’ ASA status were not reported in the paper; the authors reported only that these data were collected and that the two groups were not significantly different in terms of ASA status. Although the study provided detailed information on the three tests that are the focus of this study, the lack of information on ASA status, test indication and subsequent treatment and outcomes of treatment, means that generalising from this study to the tightly specified patients in the scope of this review is unlikely to be appropriate.

Johnson and Mortimer40 carried out a prospective audit of the medical notes of 100 patients (between 1995 and 1996) undergoing elective surgical procedures under general anaesthesia in a teaching hospital in the UK (Manchester Teaching Hospital) in order to determine the value of routine pre-operative screening investigations. These investigations included FBC, U&Es and random glucose. The investigations were performed on all patients presenting for elective surgery.

A total of 773 pre-operative screening investigations were analysed in terms of frequency of abnormalities and whether or not the perioperative management was changed when the result was abnormal. Notes were taken from different specialties (39 vascular, 35 breast and 26 urology), but no further details were given about the surgical operations that were undertaken. The costs of the tests were also examined.

The authors found that 9.1% of test results were abnormal. Perioperative management was altered as a result of only two abnormal results (0.2%). Eight complications occurred perioperatively, none of which could have been predicted by the pre-operative screening tests. A cost analysis was presented using selective ordering of tests.

The study does not give sufficient detail of the patient population or the surgical interventions that were undertaken to assume that the evidence presented is in line with the requirements of the present study. Also, given that the data from the study were derived from one hospital in the UK, generalisability of the results is limited.

The comparison of the use of pre-operative tests, operating and recovery room time for comparable groups of patients receiving inpatient or ambulatory care was undertaken by Kitz et al. 41 Hospital costs for the pre-operative tests and for nursing labour costs, based on operating and recovery room times, were also assessed.

Patients undergoing surgical arthroscopy of the knee and diagnostic laparoscopy were included in the study. Diagnostic laparoscopies were divided into two groups: (1) level 1 – visual examination of the pelvic viscera only; and (2) laparoscopy with fallopian tube lavage with methylene blue of radio-opaque dye.

The study utilised inpatient and ambulatory logs to identify patients who underwent inpatient or ambulatory surgical arthroscopy from January to June 1984. Pre-operative tests assessed included CBC, UA, ECG, Panel 6 and chest radiography.

The study provided a cost analysis including the costs of individual laboratory and radiology services. Total hospital costs for the tests were calculated for the inpatients and for the day surgery unit. The study did not aim to assess the cost-effectiveness of the tests or provide a full economic evaluation; for example, no utility data are presented in the study. The evidence is limited for informing the cost-effectiveness model as it provides only a summary of the costs for each of the tests. The costs are based on data from one institution in in the USA. Given that the study was carried out over 20 years ago, the applicability of these costs to the current study setting is extremely limited.

Larocque and Maykut42 assessed the implementation of guidelines for pre-operative laboratory investigations using a retrospective chart audit. The charts of patients were taken from a Canadian university teaching hospital (between 1991 and 1992).

Patients who had undergone both minor (e.g. cataract extraction, transurethral resection of the prostate) and major (e.g. laparoscopic cholecystectomy, hip arthroplasty, abdominal hysterectomy, breast reduction and radial neck dissection) surgery were included in the study. The study also collected data on the age of patients, any pre-existing conditions, medications, ASA status, type of surgery and type of anaesthesia. Patients in ASA grades 1–5 as well as patients undergoing both minor and major surgery were included. The results were not reported separately for each of the ASA subgroups or combinations thereof.

The outcome measures used in the study included reduction in the number of tests performed and the impact of a reduction in tests on morbidity and mortality.

The study reports the unit cost of each of the pre-operative tests and the number of tests performed. This count was compared for the pre- and post-protocol period. These data are specific to the Canadian teaching hospital in which the study was conducted and thus of limited relevance to a UK analysis. In addition, the study data were reported in an aggregate form (e.g. the total number of investigations), meaning that insufficient detail is available for use in parameterising a UK cost-effectiveness analysis.

MacPherson et al. 43 assessed whether or not the introduction of a protocol-based test ordering system (or a guideline) would reduce ordering of inappropriate pathology tests in surgical patients attending a pre-admission clinic (PAC) in a hospital based in Australia. The guideline provided information in two parts: the first contained information about tests to be ordered on the basis of the proposed surgical procedure and the second provided a list of test to be ordered according to a pre-existing medical condition.

The data were obtained from three cohorts of patients attending the PAC over three different time periods: before guideline implementation – group 1 (700 individuals attending the PAC between April and June 2002); immediate post guideline introduction – group 2 (720 individuals between April and June 2003); and the final group (group 3) included individuals attending the PAC clinic the subsequent 3-month period after the introduction of the guideline (763 individuals attending PAC from July to August 2003). The following tests were included in the study: tests of coagulation (Coags), calcium, phosphate and magnesium (CPM), EUC, FBC, group and hold tests (G&Hs), LFTs and thyroid function tests (TFTs).

The study examined the numbers of patients in each group for whom any of eight standard pathology tests had been ordered. The average number of tests per patient (group 1, 2.48; group 2, 1.88; and group 3, 1.91), and cost of tests per patient (group 1, A$42.22; group 2, A$31.89; and group 3, A$33.05) were presented. Further details of the assessment of outcome measures were not given. As with many of the other studies, the usefulness of this study as an information source for a UK cost-effectiveness analysis is limited by the lack of detailed information about the ASA status of patients and surgical interventions undertaken.

Discussion

The systematic review shows the lack of available data involving full economic evaluation of the routine pre-operative ordering of FBC, PFTs and U&Es at present. Only one full economic evaluation was identified. 36 Although we additionally reported seven further partial economic evaluations37–43 with a view to extracting data that might be used in an economic model, these too provided few data that could be utilised.

Overall, the studies identified were either non-UK based, did not involve ASA grade 1 or 2 patients or did not assess electrolytes and renal function and pulmonary function pre-operative tests. The one cost-effectiveness analysis identified explored the implications of carrying out and not carrying out pre-operative testing; however, it did not include utility-based outcomes, was more than 20 years old and was carried out in the USA. Insufficient evidence was available to construct, or aid construction of, a decision probability model for the three tests.

The seven further partial economic evaluations lacked detailed information about the study population and the surgical interventions. Three studies presented findings of guideline or protocol implementation. 37,42,43 These studies focused on deriving total costs and costs per patient to show the benefits of carrying out a reduced number of routine testing. They did not provide enough detailed cost data to inform the building of an economic model.

The demographics of the patients included in the studies were also problematic. Once again, few details were given; one study37 included a large proportion of patients aged < 16 years in the analysis and without details of any subanalysis was not applicable to our study setting. Similarly, the ASA grades included in the studies did not fit our criteria, in as much as none of the papers separated the results by ASA grade 1 and ASA grade 2 classes, which are the focus of our study.

There are some limitations to the review that should be noted. The search strategy identified a large number of studies that were not relevant. This may perhaps be the result of utilising broad search terms. However, this was necessary to ensure that relevant studies were not excluded. Additionally, papers that were not in the English language were excluded from the cost-effectiveness review. Some of these papers may have been relevant to the study setting. However, the applicability of non-UK-based studies in informing the model is likely to be limited.

Future studies assessing the cost-effectiveness of pre-operative tests would benefit from providing disaggregate information about the patients’ ASA status and the type of surgery proposed, as well as detailed data on any amendments to perioperative management in response to test results, cancellations and delays of operations and perioperative outcomes. The data would allow a better comparison between studies as well helping to characterise the clinical pathway for a cost-effectiveness model.

In terms of data required to reflect the real-world application of the tests, evidence regarding the delivery of tests would be of value in informing an economic model (i.e. delivered in a bundle or in sequence could be a valuable distinction in building an economic model).

Chapter 4 Survey of current practice on pre-operative testing in ASA grade 1 and ASA grade 2

The purpose of the survey was to capture current practice of ordering tests for patients classed as ASA grades 1 and 2 undergoing elective minor or intermediate surgery. To do this we chose to approach hospital-based pre-operative assessment clinics directly. We wanted to obtain as wide a picture as possible from those working in a wide variety of settings. Previously, the Abacus International Survey7 comprised a paper and online survey. The investigators contacted members of the Royal College of Anaesthetists (RCoA) Pre-operative Assessment Association and the British Anaesthetic & Recovery Nurses Association (BARNA) and requested that they complete their survey which covered all of the recommendations of the clinical guidelines. This audit was commissioned by NICE to gauge the impact of CG3 on clinical practice.

Chapter 5 Cost-effectiveness of pre-operative testing of full blood count, electrolytes and renal function and pulmonary function in the management of ASA grade 1 and grade 2 surgical patients undergoing minor and intermediate surgery

Results

Figure 3 shows a truncated version of the decision tree.

FIGURE 3.

Cost-effectiveness of pre-operative test – model structure. Example using FBC. –ve, negative; +ve, positive. Notes: Assess: the patient is further assessed given the unclear test result; Augmented post-operative care: the post-operative management of the patient is not according to standard care; Delay operation: the patient’s operation is delayed; Investigate: the patient undergoes further investigation to confirm his or her health status; Marginal: patient’s test result is unclear; Not marginal: the patient’s test result is not marginal (a clear test result); Standard post-operative care: the patient has standard post-operative management; Successful/unsuccessful: successful or unsuccessful treatment or operation; Treat: the patient is given a treatment if his or her test result is not clearly negative.

The underlying principle for the use of these routine pre-operative tests is the identification of an asymptomatic condition that could impact on the perioperative and/or post-operative care, prior to surgery in order to allow either an amendment to the care plan, deferring of the procedure to allow the condition to be treated so that the individual is fit for surgery or the cancellation of the surgery if the test results indicate that the balance of risks and benefits of the surgery is no longer positive and treatment of the identified condition is not likely to change the balance of risk and benefits in a relevant time scale.

For each test there is an underlying probability that a patient has the unrecognised condition and a set of test performance characteristics that indicate whether the administration of the test will correctly or incorrectly provide positive or negative results.

Associated with each test result is a clinical strategy based on the measured test result (positive or negative) and each treatment strategy has costs and outcomes associated with it. These differ according to whether the individual is a true-positive, true-negative, false-positive or false-negative. Each pathway has a health state value (utility) associated with it.

The tests operate independently, i.e. the clinical response, costs and outcomes from each test are not dependent on the results of either of the other two tests. However, a positive test result on any one of the tests is a sufficient condition to lead to an operation being delayed.

The proposed cycle length for the model was 1 week and the time horizon for the model was 6 weeks. The cycle length was chosen on the basis of the time it takes for treatments to be initiated and treatment strategies changed. The time horizon was based on the time a clinician would allow for resolution of the types of asymptomatic problems identified by these tests before choosing to cancel the operation. Inevitably there is a substantial element of judgement determining these parameters.

Table 24 reports the parameters required for the construction of the cost-effectiveness model. The evidence for each of the parameters based on the systematic literature reviews reported earlier in this report and national cost databases such as the NHS Reference Costs 2007/8 is also described in the following chapter (see third column, Table 27). 46 There is no evidence in the reported literature for the majority of the parameters required to populate the cost-effectiveness model structure developed.

TABLE 24 - Parameters required for the construction of the cost-effectiveness model

There is a wide range of operations in the minor to intermediate category with a correspondingly wide range of costs. We identified a range of costs that would be used in scenario analyses. The mean of the identified exemplar costs was to be used in the base-case analysis.

The cost of treating the condition identified by a pre-operative test is clearly dependent on what the condition is. The correct clinical response to a failed PFT can range from being relatively cheap (e.g. respiratory drugs) to extremely expensive (e.g. cardiac surgery). We identified a range of costs to be used in scenario analyses. The base-case analysis would use the least expensive treatment on the basis that otherwise symptomatically healthy patients (ASA grades 1and 2) are unlikely to have the more complex and expensive to treat health problems.

We assumed the cost of the operation included standard post-operative care. The additional cost is estimated as the difference between the cost of procedures with and without complications in the NHS reference cost for a representative sample of minor and intermediate surgeries.

Parameter	Baseline value	Published evidence
FBC
Probability of positive/negative test result	N/A	No
Probability of marginal positive/negative test result	N/A	No
Probability of successful/unsuccessful treatment after positive test result	N/A	No
Probability of successful/unsuccessful operation	N/A	No
PFT
Probability of positive/negative test result	N/A	No
Probability of marginal positive/negative test result	N/A	No
Probability of successful/unsuccessful treatment after positive test result	N/A	No
Probability of successful/unsuccessful operation	N/A	No
Costs45,46
Cost of FBC Test	£6	Yes
Cost of U&E	£4	Yes
Cost of PFT	£66	Yes
Cost of successful operationa	£781–1204	Yes
Cost of post-test investigation	£225	Yes
Cost of treatment for conditions identified by pre-operative testb	£3.28–71 per month	Yes
Additional cost of post-operative managementc	£814–5226	Yes
U&E
Probability of positive/negative test	N/A	No
Probability of marginal positive/negative test	N/A	No
Probability of successful/unsuccessful treatment after positive test result	N/A	No
Probability of successful/unsuccessful operation	N/A	No
Utilities
Pre-operative utility	N/A	No
Post-operative utilities – successful operation	N/A	No
Post-operative utility – unsuccessful operation	N/A	No

Chapter 6 Routine pre-operative testing regression analysis report

Chapter 7 Discussion

The original objective of the study reported here was to review the literature on the clinical effectiveness and cost-effectiveness of the routine pre-operative use of three diagnostic tests – FBC, U&E and PFT – in the context of minor and intermediate surgery for otherwise healthy patients, and to synthesise the evidence identified in the context of a de novo cost-effectiveness model.

A comprehensive and systematic search of both the effectiveness and cost-effectiveness literature identified a large number of potentially relevant studies. However, when these studies were subjected to detailed review and quality assessment it became clear that the literature provides no evidence on the effectiveness and cost-effectiveness of these specific tests in the specific patient groups in the context of the UK NHS.

The limitations of the published clinical effectiveness literature – from the perspective of this study – included but were not limited to:

• inadequate reporting of the surgery that patients were being prepared for

• inadequate reporting of the specific tests undertaken and the results of the individual tests

• inadequate reporting of the clinical response to test results; and

• inadequate reporting of the outcomes of the surgery.

These limitations were by and large shared by the published cost-effectiveness literature. In addition, there were almost no studies from the UK NHS, which meant that the estimates of the resource use and cost reported in the identified papers were unlikely to be relevant to the NHS. The studies also failed to report disaggregated information on resource utilisation and cost and focussed on short-term clinical outcomes rather than health outcomes.

The cost-effectiveness literature that was identified did not look at the longer-term outcomes attributable to the use or non-use of these pre-operative tests (i.e. it focused on the difference in the incidence of perioperative complications and the costs associated with these). This is perhaps attributable to the fact that the studies were generally small and investigators quite possibly did not have the resources necessary to undertake longer-term follow-up. It might also be because the relationships between perioperative complications and longer-term health outcomes are insufficiently understood to allow the construction of models to predict these longer-term consequences in the absence of data.

Whatever the reason for the lack of longer-term health outcome data for these pre-operative tests, the literature does not support any robust conclusions about the value of the routine use of these pre-operative tests compared with alternative uses of the limited health-care resources.

In addition to the literature reviews, we repeated a survey of current practice commissioned by NICE as part of their guideline review process in 2005. The results indicate that the degree of uptake of the NICE guidance on pre-operative testing has increased substantially since the original study. The responses suggest that routine pre-operative testing in minor surgery in patients aged < 40 years has all but disappeared from the NHS. 7

The results of the survey of practice could not be directly verified by this study. However, owing to the lack of published evidence we undertook an additional piece of work, analysing routine testing data from one large teaching hospital trust. The results of this analysis are discussed in more detail below, but they are consistent with the results of the survey and thus may represent a weak validation of these survey results.

The analysis of routine testing and surgical outcome data was not part of the original proposal. However, given the lack of published evidence on the clinical effectiveness and/or cost-effectiveness of these tests, and the importance of the question given the high volumes of pre-operative testing across the NHS as a whole, we deemed it important to exhaust all reasonable avenues of enquiry in pursuit of relevant evidence.

We were fortunate that Leeds Teaching Hospitals Trust had maintained a database of all tests ordered that could be linked, at the individual patient level, to a number of measures of outcome of surgery. This provided a substantial number of observations on which we could estimate regression models. Although the details of the analysis are reported elsewhere, it is worth reiterating that the essence of the work was to estimate the relationship between utilisation of any of the three tests in the pre-operative assessment and the outcomes of surgery in a cohort of otherwise healthy patients undergoing minor or intermediate surgical procedures. It should be noted that we had to approximate the ASA grade 1 and ASA grade 2 score retrospectively. This is not the same as having an original anaesthetist’s score, which further increases the uncertainty in the interpretation of the results, as the case mix of the patients in the sample may be more or less diffuse than in the study scope.

If the tests were being used routinely and they were having a positive impact on outcomes, we would expect to see that patients who received the tests were likely to have shorter lengths of stay and more likely to be discharged from hospital by 30 days. The modelled relationships were exactly the opposite of what was expected. Many patients did not undergo any of these tests and those who did were more likely to have longer lengths of stay and less likely to be discharged by 30 days post operation.

In constructing a decision-analytic model for the cost-effectiveness of these tests it became clear that a number of key determinants of the value of these tests were dependent on the specific cause of the abnormal test result. There are multiple potential causes for abnormal tests results for all three tests. The appropriate clinical response, its resource implication and the expected outcomes of the treatment and hence the potential cost-effectiveness of the test are all dependent on the underlying cause. Constructing models for each possible abnormal test/cause combination was outside the scope of this project. However, any future work examining the cost-effectiveness of these tests in pre-operative assessment will have to frame the decision problem in this context if each parameter in the decision problem is going to be clearly specified.

The most defensible conclusion to be drawn from this study is that there is insufficient evidence to support the utilisation of these three tests as part of the routine pre-operative assessment in otherwise healthy patients undergoing minor and intermediate surgery. The survey and analysis of routine data from the Leeds Teaching Hospitals NHS Trust indicate that the time of universal utilisation of these tests in pre-operative assessment may indeed have passed. However, concerns over response rates and the risks of generalising from data on a single trust make this conclusion tentative.

This study raises the question of how to proceed in an evidence-based decision-making context when there is effectively no evidence related to the decision problem. We had originally proposed to address weaknesses in the evidence by using expert elicitation. However, when it became clear that virtually all of the decision parameters in the decision problem would require expert elicitation, the appropriateness of this strategy became questionable. Challenges associated with establishing who would be the appropriate experts for different parameters in the decision model, how to ensure the representativeness of the sample, and synthesising the evidence provided by different experts on different parameters meant that wholesale elicitation was methodologically questionable and pragmatically beyond the resources of this project.

We considered that establishing a representative sample of experts for the elicitation would be essential if the results of the analysis were to be credible to the medical and decision-making community. However, it would be equally problematic as we are not aware of methods for establishing that the relatively small samples of experts that would be feasible within project resources are representative of such a large community of practitioners. For these reasons, formal elicitation of expert opinion does not appear to offer an analytical solution to the health-care decision-maker’s dilemma of how to make an evidence-based decision in the absence of evidence.

Acknowledgements

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Appendix 1 Systematic review of clinical effectiveness: MEDLINE search strategies

Appendix 2 Systematic review of clinical effectiveness: quality assessment of randomised controlled trial

Assessment tool based on NHS CRD Report No. 48

Appendix 3 Final protocol

Appendix 4 Systematic review of clinical effectiveness: tabulation of excluded studies

Appendix 5 Systematic review of clinical effectiveness: quality assessment of non-randomised studies

Appendix 6 Apparent patient flow in the study by Gnocchi et al.11

Appendix 7 Turnbull and Buck:15 summary of relevant pre-operative test results and relevant complications

Appendix 8 Review of the adverse effects of venepuncture and pulmonary function testing: methods

Appendix 9 Review of the adverse effects of venepuncture: quantity of research available

The electronic literature searches identified 466 potentially relevant articles. Of these, eight articles4,16,18–23 met the review’s inclusion criteria (see Figure 4).

FIGURE 4.

Adverse effects of venepuncture: summary of study selection and exclusion (electronic literature searches).

Three additional relevant articles, by Berry and Wallis,24 Horowitz17 and Yuan and Cohen,25 were identified only from citations.

Appendix 10 Review of the adverse effects of pulmonary function testing: quantity of research available

The electronic literature searches identified 396 potentially relevant articles. Of these, two articles14,28 met the review’s inclusion criteria (see Figure 5).

FIGURE 5.

Adverse effects of pulmonary function testing: summary of study selection and exclusion (electronic literature searches).

Three additional relevant articles, by Manço et al. ,31 Nemet et al. 32 and Varkey and Cory,33 were identified only from citations, and a fourth, by Patel et al. ,28 was identified by the clinical effectiveness searches.

Appendix 11 Search strategies for cost-effectiveness review

Appendix 12 Excluded studies: cost-effectiveness review