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Eur J Cardiothorac Surg 2003;24:270-276
© 2003 Elsevier Science NL
a Manchester Royal Infirmary, Oxford Road, Manchester, M13 3BW, UK
b Blackpool Royal Victoria Hospital (BVH), Blackpool, UK
c North Staffordshire Royal Infirmary (NSRI), Stoke-on-Trent, UK
Received 27 February 2003; received in revised form 7 April 2003; accepted 11 April 2003.
* Corresponding author. Tel.: +44-780-154-8122
e-mail: joeldunning{at}doctors.org.uk
| Abstract |
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Key Words: Thoracic surgery Ventilation Postoperative complications Decision making Clinical protocols
| 1. Introduction |
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Several studies have attempted to identify preoperative risk factors for prolonged ventilation [27], However, no study has yet described a validated predictive rule or score that will robustly predict those patients likely to require prolonged ventilation.
The aim of our study was therefore to derive and validate a clinical decision rule that would identify a cohort of patients that were at high risk of prolonged ventilation, so that the timing of their operation can be optimally planned in the context of limited intensive care resources.
| 2. Methods |
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2.2. Setting
Patient records were analysed from the North Staffordshire Royal Infirmary Open Heart Registry from March 1998 to May 2002. This is a UK centre performing 900 operations per year in the Midlands. This data was used to derive the decision rule. Patient records were then analysed from the Blackpool Victoria Hospital Open Heart Registry from January 1996 to December 1999. This is a centre of similar size in the North-West of England. This data was used to assess the external validity of the derived rule.
2.3. Subjects and outcome measures
All patients undergoing a Cardiac surgical procedure were included in the study. All clinical variables were prospectively collected according to guidelines for the UK national dataset and all independent variables were defined according to these recommendations [8].
The dependent variable was ventilation of over 24 h, as recorded by the Intensive care staff. The ventilation time was defined as the time from arriving in the Intensive care unit to the time of extubation. It is our experience that the recording of this data is highly reliable and consistent in both units. Twenty-four hours was selected by us as we felt this would be the most clinically useful cohort of patients for us to identify as opposed to alternative longer or shorter time periods. If a patient was reintubated, we considered that this would likely to be due to a new complication and thus we did not add this time to the original intubation time. Any clinical variable that had more than 1% missing data was excluded from the study.
2.4. Data analysis
Univariate analysis was initially used to determine the strength of association between each variable and the primary outcome to aid selection of variables for multivariate analyses. The North Staffordshire database was used for this analysis. Initial univariate analysis was performed on categorical data using the Pearson Chi-squared test or Fisher's exact test where any expected cell count was less than 5. Continuous variables were analysed using the unpaired Student t-test where a Gaussian distribution could be demonstrated. The remaining data, and variables containing rank data was analysed using the MannWhitney U-test. Univariate analysis and logistic regression was performed using SPSS version 11.5 [9]
Multivariate analysis was conducted using both logistic regression and recursive partitioning to find the best combinations of predictor variables that were highly sensitive for detecting the outcome measure whilst also achieving the maximum possible specificity. Regression model building proceeded with forward stepwise selection until no variables met the entry (P<0.05) or removal (P<0.10) criteria for the significance level of the likelihood-ratio test.
Recursive partitioning was performed as an alternative technique using the data mining program, CART® [10]. Our experience suggests that recursive partitioning may be more suitable than logistic regression in certain clinical situations. This has also been found in the creation of other decision rules [11].
Recursive partitioning uses the technique of binary recursive partitioning to create a decision tree. It is binary as it always splits parent nodes (or decision rules) into two child nodes. It is recursive as it then uses each child node as the parent node to create the next step in the tree. The tree is complete when further splitting produces no improvement in the predictive ability of the tree. Before commencing the analysis, we set a priori objectives of deriving a rule with a 50% sensitivity for prediction of prolonged ventilation.
2.5. Sample size
Although formal power calculations do not exist for creating a decision rule, a commonly used rule of thumb is that there should be ten outcome events per independent variable in the prediction rule [12]. We feel that a rule with over ten variables is difficult to use and thus we required at least 100 patients with prolonged ventilation. The above timeframe of data collection was thus selected so that this figure would easily be achieved in both the derivation and validation datasets.
2.6. Ethics
Ethics committees were approached but full approval for this study was not required as all data was anonymised prior to analysis.
| 3. Results |
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A scoring system was also generated using logistic regression (Table 4 and Fig. 3 ). A simple summative scoring system was generated from the odds ratios of those variables that displayed a significant relationship with prolonged ventilation after multivariate analysis, in a method similar to that of the derivation of the Parsonnet score and the Euroscore [13,14]. This was done rather than generating a complex rule from the logistic equation, as we felt that the mathematically exact rules are not useful clinically.
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Finally, a large number of patients cannot have the timings of their operation delayed and thus it is useful to know how our rule performs only in non-emergency situations. We excluded all patients having an emergency or salvage operation and all those that required an emergency re-operation. This removed 335 patients from the North Staffordshire Database of whom 85 required prolonged ventilation. It also further simplified our decision rule, by removing the last criterion.
The results are shown in Table 5. While the sensitivity was reduced to 30%, the specificity increased to 93%, and therefore only 206 patients are selected as high risk patients using this rule. The rule's performance is maintained in the Blackpool database when these patient exclusions are repeated and rule again outperforms the Parsonnet rule alone.
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| 4. Discussion |
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Our decision rule classifies 14% of all cardiac patients as high risk which we feel is highly useful clinically. In units that do not operate at the same rate during the weekend, there is often some spare capacity by the Sunday in the Intensive care unit. If a protocol was initiated in departments whereby patients identified as high risk were listed for Friday operating, then 50% of all those requiring prolonged ventilation would be initially cared for over the weekend. This would reduce the likelihood that beds would be unavailable for the next days operating.
Additionally, if there was a situation in the Intensive care where there was a period of particular pressure on beds, then delaying surgery on patients identified by us as high risk by our rule would halve the likelihood of adding a patient to the intensive care who will go on to receive prolonged ventilation.
This analysis has weaknesses. Our outcome variable of ventilation for over 24 h was accurately and consistently recorded and this is constantly monitored in our units. But the decision to extubate was left to local protocols at the two institutions or the decision making of clinicians caring for the patient. Although many patients will clearly be unable to be extubated at 24 h, there will be situations where a more aggressive extubation policy will lead to earlier extubation. This may account for the difference in incidence of patients extubated at 24 h in North Staffordshire and in Blackpool. An alternative outcome measure would have been the number of hours to achieve a set arterial oxygen partial pressure for given ventilator parameters, but we felt that this would not make the interpretation of our results easier for clinicians assessing this decision rule. Indeed by validating our rule in a unit with a different rate of prolonged ventilation, we have shown that our rule is robust to differing policies of extubation.
Our dataset does not include data on pulmonary function testing for our patients. However, Jacob et al. [15] in a cohort of 193 patients found that pulmonary function tests do not predict length of mechanical ventilation, incidence of pleural effusions or incidence of pulmonary oedema, and thus we do not think that this is a major weakness of our study.
Our decision rule identifies patients having an emergency re-operation as high risk. While these patients can clearly not have their operation times modified when using our rule to plan operative timings, we wanted to provide a decision rule that was applicable to all patients in the database. For this reason, we did not initially exclude these patients from the analysis. However, the performance of our rule also performed well when emergency patients were excluded. It should be noted that the performance of the Parsonnet score and the logistic score also deteriorates when these patients are excluded and thus our decision rule is still the optimal rule for high risk prediction.
There are well established standards for the development of clinical decision rules [16]. We have fulfilled standards required for the derivation and validation of a clinical decision rule prior to implementation, although there are several areas of further analysis that could be performed for this rule. It is recommended that each variable and the rule as a whole is assessed for inter-observer agreement. We feel that each category in our rule is has a high reliability and reproducibility, and thus we hope that different clinicians will categorise patients as high or low risk using our rule with a high degree of accuracy. We do, however, need to establish this in future studies. We also intend to investigate whether the implementation of this rule in a busy CSU can actually reduce the rate of cancelled operations in busy UK CSUs.
Our findings of preoperative clinical factors that predict prolonged ventilation agree with other studies. Branca et al. [3] identified mortality risk scoring to be the most correlated factor with prolonged ventilation, and also that only age and operative urgency could be added to this to improve its predictive ability. They did not, however, validate any recommendations for high risk patient identification. A smaller study by Spivack et al. [6] found only ejection fraction to be related to prolonged ventilation. Higgins et al. [4] derived and validated a scoring system to predict either mortality or any intensive care morbidity including prolonged ventilation. Their scoring system included severe left ventricular dysfunction, age over 65 years, and emergency operation as significant predictors for prolonged ventilation. However, this scoring system includes intra-operative factors as it was designed to assess intensive care treatment, and is thus of little use to clinicians wanting to risk-stratify patients pre-operatively.
| 5. Conclusion |
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| Acknowledgments |
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| References |
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