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.

BACKGROUND: The evidence base which supported the National Institute for Health and Clinical Excellence (NICE) published Clinical Guideline 3 was limited and 50% was graded as amber. However, the use of tests as part of pre-operative work-up remains a low-cost but high-volume activity within the NHS, with substantial resource implications. The objective of this study was to identify, evaluate and synthesise the published evidence on the clinical effectiveness and cost-effectiveness of the routine use of three tests, full blood counts (FBCs), urea and electrolytes tests (U&Es) and pulmonary function tests, in the pre-operative work-up of otherwise healthy patients undergoing minor or intermediate surgery in the NHS. OBJECTIVE: The aims of this study were to estimate the clinical effectiveness and cost-effectiveness of routine pre-operative testing of FBC, electrolytes and renal function and pulmonary function in adult patients classified as American Society of Anaesthesiologists (ASA) grades 1 and 2 undergoing elective minor (grade 1) or intermediate (grade 2) surgical procedures; to compare NICE recommendations with current practice; to evaluate the cost-effectiveness of mandating or withdrawing each of these tests in this patient group; and to identify the expected value of information and whether or not it has value to the NHS in commissioning further primary research into the use of these tests in this group of patients. DATA SOURCES: The following electronic bibliographic databases were searched: (1) BIOSIS; (2) Cumulative Index to Nursing and Allied Health Literature; (3) Cochrane Database of Systematic Reviews; (4) Cochrane Central Register of Controlled Trials; (5) EMBASE; (6) MEDLINE; (7) MEDLINE In-Process & Other Non-Indexed Citations; (8) NHS Database of Abstracts of Reviews of Effects; (9) NBS Health Technology Assessment Database; and (10) Science Citation Index. To identify grey and unpublished literature, the Cochrane Register of Controlled Trials, National Research Register Archive, National Institute for Health Research Clinical Research Network Portfolio database and the Copernic Meta-search Engine were searched. A large routine data set which recorded the results of tests was obtained from Leeds Teaching Hospitals Trust. REVIEW METHODS: A systematic review of the literature was carried out. The searches were undertaken in March to April 2008 and June 2009. Searches were designed to retrieve studies that evaluated the clinical effectiveness and cost-effectiveness of routine pre-operative testing of FBC, electrolytes and renal function and pulmonary function in the above group of patients. A postal survey of current practice in testing patients in this group pre-operatively was undertaken in 2008. An exemplar cost-effectiveness model was constructed to demonstrate what form this would have taken had there been sufficient data. A large routine data set that recorded the results of tests was obtained from Leeds Teaching Hospitals Trust. This was linked to individual patient data with surgical outcomes, and regression models were estimated. RESULTS: A comprehensive and systematic search of both the clinical 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 clinical effectiveness and cost-effectiveness of these specific tests in the specific patient groups. The postal survey had a 17% response rate. Results reported that in ASA grade 1, patients aged < 40 years with no comorbidities undergoing minor surgery did not have routine tests for FBC, electrolytes and renal function and pulmonary function. The results from the regression model showed that the frequency of test use was not consistent with the hypothesis of their routine use. FBC tests were performed in only 58% of patients in the data set and U&E testing was carried out in only 57%. LIMITATIONS: Systematic searches of the clinical effectiveness and cost-effectiveness literature found that there is no evidence on the clinical effectiveness or cost-effectiveness of these tests in this specific clinical context for the NHS. A survey of NHS hospitals found that respondent trusts were implementing current NICE guidance in relation to pre-operative testing generally, and a de novo analysis of routine data on test utilisation and post-operative outcome found that the tests were not be used in routine practice; rather, use was related to an expectation of a more complex clinical case. The paucity of published evidence is a limitation of this study. The studies included relied on non-UK health-care systems data, which may not be transferable. The inclusion of non-randomised studies is associated with an increased risk of bias and confounding. Scoping work to establish the likely mechanism of action by which tests would impact upon outcomes and resource utilisation established that the cause of an abnormal test result is likely to be a pivotal determinant of the cost-effectiveness of a pre-operative test and therefore evaluations would need to consider tests in the context of the underlying risk of specific clinical problems (i.e. risk guided rather than routine use). CONCLUSIONS: The time of universal utilisation of pre-operative tests for all surgical patients is likely to have passed. The evidence we have identified, though weak, indicates that tests are increasingly utilised in patients in whom there is a reason to consider an underlying raised risk of a clinical abnormality that should be taken into account in their clinical management. It is likely that this strategy has led to substantial resource savings for the NHS, although there is not a published evidence base to establish that this is the case. The total expenditure on pre-operative tests across the NHS remains significant. Evidence on current practice indicates that clinical practice has changed to such a degree that the original research question is no longer relevant to UK practice. Future research on the value of these tests in pre-operative work-up should be couched in terms of the clinical effectiveness and cost-effectiveness in the identification of specific clinical abnormalities in patients with a known underlying risk. We suggest that undertaking a multicentre study making use of linked, routinely collected data sets would identify the extent and nature of pre-operative testing in this group of patients. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

A randomised 2 x 2 trial of community versus hospital pulmonary rehabilitation, followed by telephone or conventional follow-up.

OBJECTIVES: To determine whether pulmonary rehabilitation carried out in a community setting is more effective than that carried out in a standard hospital setting and which is more cost-effective; also whether telephone follow-up is both cost-effective and useful in prolonging the beneficial effects of a pulmonary rehabilitation programme. DESIGN: A randomised trial. Participants were randomised in 2 x 2 factorial fashion to hospital or community rehabilitation and telephone or standard follow-up with review. SETTING: Hospitals or community sites in Sheffield. The community venues were selected to be close to public transport routes and have good parking and level access. The two hospital venues were the physiotherapy gym and a staff gym within the grounds of the hospital. PARTICIPANTS: Patients with chronic obstructive pulmonary disease diagnosed by respiratory physicians according to Global Initiative for Chronic Obstructive Lung Disease guidelines. INTERVENTIONS: Participants were randomised to one of four groups: hospital rehabilitation with no telephone follow-up; hospital rehabilitation with telephone follow-up; community rehabilitation with no telephone follow-up; or community rehabilitation with telephone follow-up. All were blinded to the telephone intervention arm until 1 month post rehabilitation, when only the assessment team and research participants were unblinded. MAIN OUTCOME MEASURES: The primary outcome measure was the difference in improvement in endurance shuttle walking test (ESWT) between hospital and community pulmonary rehabilitation groups post rehabilitation, and the difference in ESWT during 18 months' follow-up between those receiving telephone encouragement and those receiving standard care. A secondary measure was health-related quality of life. RESULTS: A total of 240 participants had evaluable data. Of these, 129 were randomised to hospital rehabilitation (64 with telephone follow-up and 65 with no telephone follow-up) and 111 to community rehabilitation (55 with telephone follow-up and 56 with no telephone follow-up). For the primary outcome measure, there were 162 patients with data for analysis: hospital rehabilitation with no telephone follow-up (n = 38); hospital rehabilitation with telephone follow-up (n = 48); community rehabilitation with no telephone follow-up (n = 43); and community rehabilitation with telephone follow-up (n = 33). For the acute phase post-rehabilitation outcomes, before patients had the opportunity for telephone follow-up, we compared outcomes between the 76 patients in the community rehabilitation group and the 86 patients in the hospital rehabilitation group. Patients in the hospital rehabilitation group increased the distance they could walk at the post-rehabilitation follow-up by 283 m (SD 360 m), an increase relative to baseline of 109% (SD 137%). Patients in the community rehabilitation group increased the distance they could walk at the post-rehabilitation follow-up by 216 m (SD 340 m), an increase relative to baseline of 91% (SD 133%). There was no statistically significant difference between the groups [17.8% (95% CI -24.3 to 59.9, p = 0.405)]. For longer term outcomes at 6, 12 and 18 months post rehabilitation there was no evidence of a rehabilitation group effect. After allowing for the initial post-rehabilitation baseline distance walked, time (follow-up visit) and the factorial design (telephone follow-up group), the average difference in the post-rehabilitation follow-up distance walked on the ESWT between the hospital and community rehabilitation groups was 1.5 m (95% CI -82.1 to 97.2, p = 0.971), and between the telephone and no-telephone groups it was 56.9 m (95% CI -25.2 to 139, p = 0.174). There was no difference between hospital or community groups in terms of acute effect or persistence of effect. Health economic analysis favoured neither hospital nor community settings, nor did it clearly favour telephone follow-up or routine care. CONCLUSIONS: Pulmonary rehabilitation delivered in a community setting has similar efficacy to that produced in a more traditional hospital-based setting, both settings producing significant improvements in terms of exercise capacity and quality of life acutely and after long-term follow-up. Health economic analysis showed that neither hospital nor community programmes were greatly favoured. The choice of model will depend on local factors of convenience, existing availability of resources and incremental costs. Staff characteristics may be important in gaining optimal outcome, and care should be taken in staff recruitment and training. TRIAL REGISTRATION: Current Controlled Trials ISRCTN86821773.