Abstract
Background:
The evaluation of trauma center performance implies the use of indicators that evaluate clinical processes. Despite the availability of routinely collected clinical data in most trauma systems, quality improvement efforts are often limited to hospital-based audit of adverse patient outcomes.
Objective:
To identify and evaluate a series of process performance indicators (PPI) that can be calculated using routinely collected trauma registry data.
Materials and Methods:
PPI were identified using a review of published literature, trauma system documentation, and expert consensus. Data from the 59 trauma centers of the Quebec trauma system (1999, 2006; N = 99,444) were used to calculate estimates of conformity to each PPI for each trauma center. Outliers were identified by comparing each center to the global mean. PPI were evaluated in terms of discrimination (between-center variance), construct validity (correlation with designation level and patient volume), and forecasting (correlation over time).
Results:
Fifteen PPI were retained. Global proportions of conformity ranged between 6% for reduction of a major dislocation within 1 h and 97% for therapeutic laparotomy. Between-center variance was statistically significant for 13 PPI. Five PPI were significantly associated with designation level, 7 were associated with volume, and 11 were correlated over time.
Conclusion:
In our trauma system, results suggest that a series of 15 PPI supported by literature review or expert opinion can be calculated using routinely collected trauma registry data. We have provided evidence of their discrimination, construct validity, and forecasting properties. The between-center variance observed in this study highlights the importance of evaluating process performance in integrated trauma systems.
Keywords: Clinical processes, performance indicators, quality of care, trauma system
INTRODUCTION
With the exponential rise in health care costs, health care authorities worldwide are expressing the urgent need to obtain information on health care performance.[1] Evidence has suggested that the dissemination of data on performance can lead to improvements in the quality and efficiency of health care services.[2,3] The most widely used conceptual model for health care performance evaluation, proposed by Donabedian, describes performance according to three domains: Structure, process, and outcome.[4] Process indicators refer to clinical processes performed in the health care setting and should be relevant, reliable, accessible, and clear.[2] Accessibility implies that they can be evaluated at low cost with data that are easy to obtain on a routine basis.[2] According to the US Agency for Healthcare Quality, performance indicators should be evaluated using measures of discrimination, validity, and forecasting.[5]
Currently, trauma quality assurance activities vary greatly across trauma systems and are often limited to hospital-based audit of adverse patient outcomes despite the availability of clinical data in trauma registries.[6] In addition, while numerous process indicators have been suggested in the literature, many cannot be applied using registry data, and evidence of their validity is scarce.[7]
The objectives of this study were to (1) identify a series of process performance indicators (PPI) supported by literature review and/or expert consensus that can be calculated using trauma registry data and (2) evaluate selected PPI in terms of discrimination, construct validity, and forecasting.
MATERIALS AND METHODS
Identifying PPI
PPI were selected in three stages. First, a review of the literature was performed to identify which of these PPI were supported by literature published between 1985 and 2008 using PubMed, EmBase, CINAHL, Cochrane, and Proquest. Second, a review of websites of state/provincial authorities, professional associations, and trauma centers from the USA, Canada, and Australia was performed to identify PPI that were used in practice. Third, a multidisciplinary group of clinical experts serving as a steering committee for the Quebec provincial trauma system had already established 14 PPI they intended to follow. PPI were selected if they met any of the following three criteria: Supported by the literature, used by at least two systems without literature support, or suggested by the group of experts. PPI definitions were based on the literature. PPI definitions that varied across systems for the same indicator (e.g., delays to operate) were refined by the steering committee. PPI that could be measured using the Quebec Trauma Registry were then identified (and calculated for each of the 59 designated trauma centers.
Study data
This multicenter retrospective cohort study was based on the inclusive trauma system of the province of Quebec, Canada. The Quebec trauma system was instated in 1993 and involves regionalized care from urban level I trauma centers through to rural community hospitals. Trauma level designations are based on American College of Surgeons criteria and are revised periodically with on-site visits.[8] During the study period, the system included 6 level I (including 2 pediatric), 4 level II, 21 level III, and 28 level IV trauma centers. Standardized pre-hospital protocols ensure that major trauma cases are taken to these hospitals and standing agreements regulate between-center transfers within the system.
Data were drawn from the Quebec Trauma Registry, which is mandatory for all 59 designated trauma centers and includes all deaths following injury, intensive care unit admissions, hospital stays >2 days, and between-center transfers. The Province of Quebec, Canada, has universal health coverage, and linkage with hospital discharge data has shown that the trauma registry captures approximately 75% of all trauma patients who meet these inclusion criteria and more than 85% of the most severe pathologies (i.e., traumatic brain injuries, thoracic and abdominal injuries).[9] The trauma registry is based on the American College of Surgeons model. Registry data are extracted from patient files by medical archivists who use standardized coding protocols. Anatomic injury is coded with the Abbreviated Injury Scale (AIS) according to the guidelines published by the Association for the Advancement of Automotive Medicine.[10] The registry is centralized at the Quebec Ministry of Health and is subject to both systematic and periodic validation to identify and correct aberrant data values in all relevant data fields and to verify date and time chronology. Supervision by a data coordinator, yearly on-going training, an electronic forum of coding queries, and thrice-yearly meetings with key stakeholders (e.g., trauma physicians, researchers, administrators) are used to improve data reliability and validity.
This study was based on data collected during eight administrative years, i.e., between April 1998 and March 2006. Deaths on arrival and patients who arrived with no vital signs and expired within 30 min of arrival were considered inevitable in the context of trauma center evaluation and were thus excluded from the study population. Patients with an isolated hip fracture were also excluded because this pathology is commonly considered to be the consequence of a chronic disease rather than a traumatic event.[11] Hospital readmissions are not included in the trauma registry. If patients are entered twice for the same injury due to transfer, only information from the definitive acute care hospital was retained. Only 2% of patients in the study sample were included more than once in the registry for repeated traumatic events.
Implementing PPI
We first identified the patient population eligible for each PPI. Conformity to the PPI was then established for each patient in the eligible population. The observed proportion of conformity, calculated as the ratio of patients whose care conforms to the PPI divided by all patients eligible for the PPI, is subject to regression to the mean bias whereby it is more extreme than the “true” proportion, particularly for low-volume centers.[12] We therefore used shrinkage techniques that estimate the “true” proportion using information from all centers rather than just the center under evaluation – estimates are shrunk toward the global mean by a factor that is inversely proportional to the sample size.[13] These shrinkage estimates not only account for regression-to-the-mean bias, but also improve the precision of estimates for low-volume centers and account for inflation of the type I error due to multiple comparisons, which otherwise leads to the detection of too many outliers. Efron and Morris[13] argue that estimates derived through shrinkage are more suitable for policy making, for ordering (i.e., ranking), and for group comparisons (i.e., between-center comparisons) than conventional estimates and they have become standard for health care performance evaluation.[13] The “true” proportion of conformity to each PPI along with 95% confidence intervals (CI) for each of the 59 trauma centers was calculated using a random-intercept multilevel model. Conformity to each PPI is presented using a modified caterpillar plot where centers are ordered by designation level and volume to avoid ranking and to conserve the order of centers across PPI. Outliers are defined as trauma centers with 95% CI that exclude the global mean.
Evaluating PPI
PPI were evaluated using measures of discrimination, construct validity, and forecasting, according to US Agency for Healthcare Quality recommendations.[5] Discrimination was defined as the ability of PPI to differentiate performance and was evaluated using between-center variance estimates along with 95% CI. CI that exclude 0 are considered to be consistent with significant deviations across trauma centers.[14] Construct validity was defined as the degree of association between specific PPI and other indicators of quality and was assessed by evaluating the correlation between each indicator and two hospital characteristics that have been shown to be related to performance: (i) designation level and (ii) volume. Forecasting was defined as the ability of PPI to predict future performance and was assessed by evaluating the correlation within indicators over time; indicators derived from data collected in the first 4 years of the study were compared to the same indicators derived from data collected in the last 4 years. Correlation was assessed with Pearson's correlation coefficient and asymptotic 95% CI on “true” proportions (shrinkage estimates). These proportions were first transformed using a square-root arcsine transformation to normalize their distribution[15] and were then weighted with the median number of eligible patients across PPI for each center.
All analyses were performed with the SAS system (SAS Institute Inc., Cary, NC, USA; Version 9.2). Ethical approval was obtained from institutional ethics committees and the “Commision de l’accès à l’information du Québec.” The identity of trauma centers is not revealed to protect institutional confidentiality.
RESULTS
Identification of PPI
We identified 130 articles in peer-reviewed journals as well as 60 documents from websites of trauma centers, health authorities, and professional associations, which led to the identification of 137 PPI. After regrouping similar PPI, the list was reduced to 48. Applying the three selection criteria further reduced the list to 32 indicators (listed in the Appendix). Twenty-three were backed up by literature published in peer-reviewed journals, five were used by at least two trauma systems without literature support, and four were identified by the Quebec steering committee. Of the 32 PPI, 15 were obtainable from Quebec Trauma Registry data listed in Table 1.
Table 1.
Study population
The Quebec Trauma Registry contains information on 125,907 patients admitted between April 1998 and March 2006. The exclusion of deaths on arrival and deaths occurring within 30 min of arrival in patients without vital signs (n = 4837) and isolated hip fractures (n = 21,626) resulted in a sample of 99,444 patients from 59 centers available for analyses. Mean age (±standard deviation) was 48.5 years (±25.2), 30.7% of patients were 65 years of age or over, 58.4% were men, 20% had an Injury Severity Score (ISS) >15, and 29% were injured in a motor vehicle collision. Penetrating trauma represented only 4% of the study sample. Trauma center average yearly volume of patients respecting the study inclusion criteria was 218-1313 for level I centers, 341-605 for level II centers, 100-541 for level III centers, and 5-118 for level IV centers.
Overall conformity to PPI related to transfer of patients to level I/II trauma centers (PPI #1-#3) was high, whereas conformity to PPI associated with a delay of 1 h (#4, #8, #10) was low [Table 1]. A wide range of conformity across trauma centers (min-max) was observed for all PPI except #6, #8, and #10, and trauma center outliers were detected for all but two PPI.
Figures 1-3 show between-center performance for three PPI (three examples were selected as space constraints precluded presentation of all 15). Only level III/IV centers were evaluated for PPI #1 “transfer of moderate-severe traumatic brain injury patients to a level I/II center” and overall conformity for this PPI was over 80% [Figure 1]. Seven centers had higher than average conformity, whereas five centers had lower than average conformity. Overall conformity for PPI #5, securing patients’ airway in the Emergency Department (ED), was only 64% [Figure 2]. Eight of the 10 level I/II centers had higher than average conformity, whereas 3 out of 21 level III centers had lower than average conformity. Global conformity to PPI #12, ED stay <4 h, was only 49%. Seven of 10 level I/II centers had higher than average conformity, while 8 out of 21 level III centers had lower than average conformity [Figure 3].
All PPI, apart from stabilize/embolize unstable pelvic fractures and epidural hematoma surgery <1 h (both associated with very small sample sizes), were associated with statistically significant between-center variance, indicating their ability to discriminate between trauma centers [Table 2]. Five of the 10 PPI that applied to all levels of care had a statistically significant association with designation level. In particular, conformity to timely reduction of major dislocations (#4), airway protection (#5), and deaths on the ward rather than in the ED later than 1 h following arrival (#11) was higher in level I/II centers than in level III/IV centers [Table 2]. Similar results were observed for patient volume with the exception that conformity to timely surgery for open long bone fractures (#7) and therapeutic laparotomy (#13) was lower in centers with high annual patient volumes. We observed a significant positive correlation between performance results in the two eras (April 1998 – March2002 and April 2002 – March 2006) for 11 of the 13 PPI with sufficient data [Table 2].
Table 2.
DISCUSSION
In this multicenter retrospective cohort study, we identified a series of PPI based on literature review and expert consensus that can be calculated using trauma registry data. Results provide evidence of their discrimination, construct validity, and forecasting properties. These PPI can be implemented rapidly with routinely collected data and can be used to drive system-wide quality improvement efforts. The between-center variance observed in this study highlights the importance of evaluating process performance in integrated trauma systems.
Significant between-center variance indicates that all but two of the 15 PPI discriminate well across trauma centers. High correlation in performance between the two time periods demonstrates that most indicators have good forecasting properties; the performance of a trauma center in a given period of time is associated with that in the next period. In addition, PPI #4 (reduce dislocation of major articulations in <1 h), #5 (airway secured in ED for patients with Glasgow Coma Score <9), and #11 (deaths >1 h after arrival occur on ward) had statistically significant positive associations with designation level and volume. These results partially support their construct validity; level I/II trauma centers may be expected to show higher conformity to standards of care than level III/IV centers. In addition, higher levels of care and increased patient volume have been reported to be associated with improved patient outcome.[16,17] However, level I/II centers showed lower conformity to PPI #3 (transfer of spinal cord injury) and PPI #15 (no reintubation within 48 h of extubation) than lower level centers. For PPI #3, this situation is well documented in our system where a certain reluctance to transfer spinal cord injuries has been identified.
According to a recent systematic review published by Stelfox and colleagues,[7] only four multicenter studies based on global adult trauma populations have described the implementation of a series of PPI using trauma registry data.[18–21] None were implemented across all levels of trauma care. In addition, all were based on American College of Surgeons Committee on Trauma (ASCOT) audit filters proposed in 1993[8] despite the fact that only 19% of all PPI identified in the systematic review were ASCOT based.[7] Results of these studies suggest that only 9 of the 22 ASCOT filters are applicable with regular trauma registry data.
Evidence of the validity and reliability of trauma care performance indicators is scarce.[7] Evidence for reliability is mostly limited to preventable death classification and no information is available on the reliability of PPI derived from trauma registry data.[7] Work by Stelfox and colleagues suggests that there is no evidence of content validity or construct validity on trauma care process indicators derived from trauma registry data in the literature[7] and we found no study evaluating forecasting properties. Predictive criterion validity of certain PPI has been evaluated by assessing associations with outcomes such as mortality, morbidity, length of stay, costs, and complications.[18–21] However, results are contradictory and suggest that as many PPI are associated with favorable outcomes as with poor outcomes.[22] However, few of these studies used robust risk adjustment techniques and many were based on patient-level rather than hospital-level data which is subject to confounding by indication.[23]
Strengths and limitations
This study was based on a trauma registry with excellent population coverage of moderate to major trauma and rigorous data quality control mechanisms. In addition, the trauma registry used for analyses is based on uniform inclusion criteria with standardized prospective data collection procedures and represents an inclusive trauma system where designation is conducted according to American College of Surgeons Committee on Trauma criteria.[8] PPI were selected using a review of trauma system documents and peer-reviewed articles and the validity of indicators was partly addressed in analyses.
Potential limitations which may affect the interpretation of results include data quality, low volumes, and the generalizability of results. The validity of PPI relies on the reliability, validity, and completeness of trauma registry data, and data quality control measures are an essential part of any trauma system data collection effort. The Quebec Trauma Registry uses standardized coding procedures and rigorous data quality control mechanisms to improve data validity and reliability, and PPI were retained based on data quality issues as well as feasibility. However, as is common in trauma registries,[24] a high proportion of patients had missing data on physiological status. Multiple imputation procedures, widely used to address missing data in group comparisons, are not suitable for flagging individuals.[25] Missing physiological data, specifically the Glasgow Coma Score, was an issue for PPI #1, #5, and #10. This and other data quality issues may generate misleading results if data quality and completeness vary across trauma centers.
Some PPI are based on low numbers of eligible patients, particularly for low-volume centers. For example, “stabilize/embolize unstable pelvic fracture” and “epidural hematoma surgery <1 h” only had 40 and 254 eligible patients over the entire study period, respectively. This problem is partly addressed by multilevel modeling which shrinks estimates based on low sample sizes toward the global mean to improve precision. However, PPI may not be informative due to low sample sizes. Indeed, in the study population, no outliers were detected, indicating that these PPI do not discriminate across centers. Despite this, experts tend to agree that indicators should not be discarded based on low sample sizes alone because they may be flagged for high-volume centers and they can be useful for the calculation of composite performance measures.[26]
The Quebec Trauma Registry is based on American College of Surgeons criteria, but cannot directly replicate all trauma registries. Therefore, the PPI used here will not be integrally applicable across all trauma systems. In addition, PPI that can currently be evaluated using data collected in most trauma systems are unlikely to be the only PPI of interest. Indeed, out of 32 PPI that we identified from literature review and expert opinion, 17 were rejected because they could not be calculated (accurately) using Quebec Trauma Registry data. In addition, certain PPI could not be refined optimally due to lack of information in the trauma registry (e.g., taking account of non-surgical management decisions). In the long term, trauma registries should be adapted to a series of consensus-based PPI that have demonstrated not only discrimination, construct validity, and forecasting, but also reliability and predictive criterion validity on outcomes that may be more meaningful than mortality.[27,28] However, feasibility and the cost of data collection should be part of the selection process. In any event, process indicators are not static and will need to be adapted to local clinical contexts and be revised over time according to evidence-based clinical practice.
CONCLUSION
This study provides evidence of the feasibility and importance of implementing PPI using trauma registry data and gives guidance on methodological issues and presentation of results. We have identified a series of 15 PPI that can be used to drive system-wide trauma care quality improvement efforts using routinely collected trauma registry data. We have partially demonstrated the validity of these indicators. However, future research should evaluate the association between PPI and indicators of structure and outcome performance using hospital-level data as well as the influence of data quality. In addition, efforts should be invested into developing a composite measure of process performance.
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Appendix: 32 Process performance indicators
Footnotes
Source of Support: The Canadian Health Services Research Foundation, the Fondation de recherche du Québec en Santé (project #RC2-1460-05), and the Canadian Health Services Research Foundation (LM is a recipient of a new investigator award).
Conflict of Interest: None declared.
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