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Division of General Thoracic Surgery, Mayo Clinic, Rochester, Minnesota
Accepted for publication April 9, 2008.
* Address correspondence to Dr Cassivi, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (Email: cassivi.stephen{at}mayo.edu).
Presented at the Poster Session of the Forty-third Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 29–31, 2007.
| Cardiothoracic anesthesiology:
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Methods: Our thoracic surgical team developed a set of patient-centered quality of care measures specific to patients undergoing pulmonary resection. Measures were chosen that demonstrated evidence-based preoperative assessment, adequate mediastinal staging, and interventions to prevent and expeditiously treat postoperative morbidity. Medical records of all patients undergoing pulmonary resection in 2005 were analyzed.
Results: In all, 606 patients (men:women = 330:276) underwent 628 pulmonary resections. Median age was 65.8 years (range, 2 to 93). Operative mortality was 2.1%. Pulmonary function testing within 1 year before surgery was documented in 74.2%. Electrocardiogram within 90 days before surgery was documented in 81.6% of patients 50 years and older. Smoking history was documented in all patients, and smoking cessation consultation was offered to 85.7% of current smokers. Deep venous thrombosis prophylaxis was implemented in 99.7%. Mediastinal staging was documented in 94.0% of patients undergoing lung cancer resection (n = 333). Postoperatively, 92.4% of patients used incentive spirometry. Atrial fibrillation treatment occurred within 45 minutes of onset in 70.5%. Postoperative analog pain scores were above 6 in only 7.4% of assessments; treatment and reassessment occurred within 2 hours in 81.0%. Follow-up planning was documented at hospital discharge in 100%. No National Quality Forum "never events" occurred.
Conclusions: Patient-centered and clinically relevant quality measures can be developed and evaluated in general thoracic surgery. This panel of quality indicators highlights and guide areas for potential improvement in the care of patients undergoing pulmonary resection.
The quality of surgical care delivered to patients is becoming increasingly scrutinized [1, 2]. Despite this increased attention, a "quality chasm" exists in terms of general care of hospitalized patients [3]. Analysis in the area of quality of care has been driven by various constituencies with often similar, yet at times diverse, motives and objectives. In general, surgeons, as a professional group, have a long tradition of critically reviewing their outcomes at morbidity and mortality conferences with the aim of identifying areas for improvement [4]. Healthcare payers, including government and private insurers, are becoming progressively more interested in identifying measures of quality care. These measures are utilized to direct patients to high-quality practices and impose process changes to improve quality and reduce cost [5]. Most importantly, patients need and are demanding data regarding outcomes to improve the decision-making process with regard to their healthcare options.
More than 30,000 patients undergo pulmonary resection (not including diagnostic lung biopsies) each year in the United States [6]. Despite this large number of surgical procedures, there remain to date no standard criteria to measure the quality of care received by patients undergoing pulmonary resection. Our general thoracic surgical team developed an a priori set of patient-centered quality of care measures, specific to patients undergoing pulmonary resection. We chose to use measures of process as the basis of our set of quality of care criteria. This report describes our findings using data from all patients undergoing pulmonary resection in our practice.
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Operative mortality was defined as death during the initial postoperative hospitalization or within 30 days of the operation. Of the 27 "never events" established by the National Quality Forum, we chose 16 specifically relevant to patients undergoing pulmonary resection (Table 2) [7]. Pulmonary function testing was acceptable when performed no more than 1 year before pulmonary resection in an American Thoracic Society–approved clinical laboratory and when it included, at a minimum, the forced expiratory volume in one second (FEV1) and diffusing capacity of carbon monoxide (DLCO). The electrocardiogram (ECG) for patients 50 years of age or older met the accepted criteria when it was obtained and interpreted by a cardiologist no more than 90 days before the pulmonary resection.
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Mediastinal staging was considered to have met the necessary criteria when at least one of three staging modalities had been performed: cervical mediastinoscopy with lymph node biopsy, positron emission tomography, or intraoperative mediastinal lymphadenectomy. This was measured only in patients with a diagnosis of primary lung cancer.
Deep venous thrombosis prophylaxis was considered appropriate if at least one of the following processes had been accomplished or implemented: use of graduated elastic compression stockings, use of lower extremity sequential compression devices, or administration of subcutaneous heparin.
All patients received their postoperative care in a specialized setting that included continuous cardiac rhythm monitoring. Occurrences of atrial fibrillation were identified and analyzed. New onset atrial fibrillation with rapid ventricular response (heart rate > 100 beats per minute) was recorded along with the time interval between onset, as documented by the cardiac monitor, and when directed treatment was received by the patient. Similarly, postoperative pain management was analyzed by noting the number of occurrences of pain greater than or equal to 6 on a standard visual analog scale of 0 to 10. Whether treatment was received by the patient, as well as documentation of reassessment of pain within 2 hours, was tabulated.
Continuity of care in the form of follow-up evaluation was assessed by determining whether a clearly defined plan of care and return appointment for postoperative clinical examination and coordination of follow-up care was documented in the discharge summary given to the patient at the time of their discharge from hospital.
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Of those 333 patients undergoing pulmonary resection for primary lung cancer, mediastinal staging was accomplished by at least one of the three criteria processes in 313 cases (94.0%). Cervical mediastinoscopy with lymph node biopsy was done in 90 patients (27.0%), positron emission tomography in 199 (59.8%), mediastinal lymphadenectomy in 283 (85.0%), and all three modalities in 60 (18.0%; Table 4). New onset atrial fibrillation with rapid ventricular response was documented in 44 patients (7.3%), with 31 (70.5%) receiving antiarrhythmia treatment within 45 minutes of onset.
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The lack of any proposed measures of quality of care in general thoracic surgery creates a noticeable void as compared with what has been developed in cardiac surgery, where the study of surgical quality is clearly more mature. The initial impetus for cardiac surgery interest in this field was in large part a response to the publishing of raw, non–risk-adjusted Medicare mortality by the federal government followed by imposed governmental reporting requirements over the ensuing years [8]. The Society of Thoracic Surgeons has responded to these requirements by developing a cardiac surgery database that eventually became a widespread and representative compilation of the current practice of cardiac surgery in North America [9]. Its robust nature, due to increasing participation by cardiothoracic surgeons, allows for overall measurement of clinical data with analysis and benchmarking both at the regional and local levels. Unfortunately, the relatively newer general thoracic surgery database is not yet at the same level of development or participation.
Where a void in the study of quality of care exists, other groups such as government, private payers, and healthcare oversight groups (ie, Leapfrog, Health Grades) have been all too ready to impose their version of quality metrics. The risk, of course, is that such actions may result in proposed measures that emphasize areas of dubious clinical relevance or provide data related to outcomes that are not risk adjusted [10]. In the current study, our efforts were focused on providing a starting point for discussion and measurement of clinically relevant indicators of quality specific to patients undergoing pulmonary resections. We believe that thoracic surgical teams, working daily in this field, are the best able to define quality and guide the development of appropriate standards.
Operative mortality, although easily definable, is difficult to use as a measure of quality of care as it is, fortunately, an uncommon event for most surgical procedures and, therefore, usually underpowered to make significant distinctions in evaluating quality [11, 12]. Procedural volume is another commonly cited measure used to define quality of care as it is often correlated with improved outcomes [13]. This metric, however, is not a flexible tool that is actionable and, therefore, it does not allow for any practical generalized programmatic improvement [14]. In general, where successful measures of quality of care have been proposed and widely accepted, these have been measures of process, specific to the care being provided [15].
In developing our proposed quality measures, we chose factors that were clinically relevant in the care of patients undergoing pulmonary resection such as the preoperative evaluation, the extent of mediastinal staging for primary lung cancer, perioperative care measures focused on avoidance of complications, and continuity of care in follow-up. We based our criteria, when possible, on evidence-based areas of our practice.
Pulmonary function testing is a basic part of the evaluation of patients being considered for possible pulmonary resection. Obtaining standard pulmonary function tests including FEV1 and DLCO allows for estimating postoperative function and therefore allows for planning the extent of resection. Many studies have shown that FEV1 and DLCO, along with their predicted postoperative estimates, are good prognostic indicators for postresection lung function and mortality [16, 17]. The American College of Chest Physicians has recommended the use of both FEV1 and DLCO as "complementary" measures of pulmonary function when planning for pulmonary resections for lung cancer [18]. As a measure of the thoroughness of the preoperative assessment, it therefore would seem reasonable to expect that FEV1 and DLCO be evaluated so that this relevant information is available for planning an appropriate pulmonary resection. Similarly, obtaining an ECG before pulmonary resection is useful, along with the patient history, in identifying patients at higher risk for cardiovascular complications [19, 20]. Failure to obtain this simple test is a marker for inadequate preoperative evaluation.
Smoking history is a vital part of a complete history in patients with pulmonary disease and especially in those being considered for possible lung resection. As part of the diagnostic search for indeterminate pulmonary processes, the patient's smoking history plays an integral role as smoking is implicated in more than 90% of lung cancer cases [21]. The preoperative knowledge of the patient's smoking history is, therefore, essential to properly plan any potential intervention including pulmonary resection. Smoking history is useful in identifying patients who may be at increased risk for postoperative complications due to diminished pulmonary reserve in general and impaired mucociliary clearance in particular [22].
Smoking has been shown to be a significant independent prognostic factor for long-term survival in patients diagnosed with lung cancer [23]. It is therefore incumbent on those treating these patients to not only counsel patients on smoking cessation but also provide the necessary support and resources for them to achieve smoking cessation. Assistance through a formal smoking cessation program is known to be the most effective approach [24].
When treating lung cancer, the most important factor in determining prognosis and treatment options is stage. Mediastinal staging is an essential component of this process. In a recent survey of general thoracic surgery practice, Little and colleagues [25] reported that cervical mediastinoscopy was performed in only 27.1% of patients with lung cancer. Strikingly, of these patients undergoing mediastinoscopy, 53.4% had no lymph nodes biopsied [25]. Currently, there is debate as to the most effective standard for staging the mediastinum in patients with lung cancer [26]. It is clear, nevertheless, that mediastinal staging should be performed as part of a complete evaluation and treatment of patients with lung cancer. At a minimum, at least one or a combination of cervical mediastinoscopy, positron emission tomography, and mediastinal lymphadenectomy should be employed.
Prophylaxis for deep venous thrombosis has been proposed as a measure of process in various quality fora [27]. There has been debate, however, regarding the degree of risk of deep venous thrombosis and subsequent venous thromboembolism after some surgical procedures [28]. Nevertheless, patients undergoing pulmonary resection, and specifically patients with lung cancer, are at a significantly increased risk of deep venous thrombosis with potentially devastating consequences when this occurs [29, 30]. Similar to mediastinal staging, many options exist for deep venous thrombosis prophylaxis. We believe that documenting the use of at least one of the standard modalities, along with early postoperative patient ambulation, would serve as a minimum process standard.
The use of postoperative incentive spirometry, as part of appropriate postoperative respiratory therapy, has been promoted since the 1980s [31]. Although numerous studies have investigated the role of incentive spirometry after abdominal surgery, relatively few have been published after thoracotomy. That is likely because of the general acceptance of this modality, on its own merits, or more recently as part of a structured postthoracotomy respiratory physiotherapy regimen [32].
Atrial fibrillation is a common complication after thoracotomy and most intrathoracic procedures [33]. No standard prophylactic regimen has been proven to decrease the incidence of postoperative atrial fibrillation. Diagnosis and timely treatment of these occurrences should therefore be a goal.
Adequate pain control remains by far a key component of patients' perception of a successful procedure [34]. Frequent assessment of pain with timely treatment and reassessment of pain scores have been identified as process indicators of quality of care in the postoperative period [35, 36]. Similarly, in a recent Dutch study of quality of lung cancer care, adequate pain control for both operative and nonoperative cases was a proposed measure [37].
Although most quality measures to date have focused on outcomes data, these are limited by their lack of easily identified actionable variables. Quality improvement initiatives are not advanced in this way since how one surgeon/hospital achieved a certain mortality rate is not readily discernible from pure outcomes-based measures. Process measures, conversely, are more mutable and can lead more directly to changes in practice. They are not, in general, confounded by lack of risk adjustment, and therefore are less apt to penalize those who treat the sickest patients.
A recognized limitation of this study is its retrospective nature, which is borne by this being a relatively new field of study, not previously reported in our surgical specialty. Our prime goal, in this initial endeavor, was to establish a framework for assessment of process measures in our practice. Progress in quality improvement initiatives clearly begins with measuring baseline levels of compliance with agreed upon process measures. These data identify areas requiring improvement. The task then becomes one of developing plans to address those areas of relative deficiency. Retesting of compliance levels allows for ongoing adjustments aimed at incremental and measurable improvement.
At our institution, a quality support team has been established to assist the division of general thoracic surgery in maintenance and progress of these initiatives. This is further supported at the department of surgery level by a standing committee that meets regularly to review ongoing assessments of quality measures such as those discussed in this manuscript.
In late 2006, the United States Department of Health and Human Services, as directed by an Executive Order signed by President George W. Bush, launched a national initiative built on four cornerstones including publication of quality standards; publication of healthcare cost and prices charged; pay for performance incentives; and expansion of interoperable health information technology systems [38, 39]. As an adjunct or catalyst to the quality of care initiative, "pay for performance" will inevitably provide the final motivation for those who may not see the urgency of addressing the current void of quality measures [40].
The goal of quality improvement in surgery must be met, at least initially, by development of evidence-based, or when this is lacking, by consensus-based measures of process. That can be done while databases are developing, through accrual, a level of statistical robustness that will allow not only for appropriate risk adjustment but also for development of validation tools for the proposed process measures.
A panel of patient-centered quality of care indicators can be identified and measured in general thoracic surgery. Process measures that allow certain thoracic surgery practices to consistently obtain excellent results should be emphasized and disseminated. As a result, variability in the care of patients undergoing pulmonary resection can be reduced, and overall quality of care can be improved.
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