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Ann Thorac Surg 2007;84:410-416
© 2007 The Society of Thoracic Surgeons
Division of Thoracic Surgery, Umberto I Regional Hospital, Ancona, Italy
Accepted for publication April 2, 2007.
* Address correspondence to Dr Brunelli, Via Santa Margherita 23, Ancona, 60124, Italy (Email: alexit_2000{at}yahoo.com).
| Abstract |
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Methods: In all, 156 consecutive patients (144 lobectomies, 12 pneumonectomies) were prospectively assessed by means of the Short Form-36 Health Survey, version 2, preoperatively and 1 month and 3 months after operation. Serial quality of life scales were compared by repeated measures analysis of variance.
Results: In our series, most quality of life values were reduced compared with the general population. Compared with preoperative values, the physical composite scale was significantly reduced at 1 month (51 versus 45.1, p < 0.0001), and completely recovered at 3 months (51 versus 52.4, p = 0.2), whereas the mental composite scale remained unchanged. All correlation coefficients between these values and forced expiratory volume in 1 second, carbon monoxide lung diffusion capacity, and height reached at stair-climbing test at each evaluation period were below 0.2. With the exception of pneumonectomy patients (who had a significantly lower physical composite scale [p = 0.04]), no significant differences in both physical and mental values were noted in other high-risk subgroups of patients (elderly, coronary artery disease, poor pulmonary function) compared with lower-risk counterparts.
Conclusions: Candidates for lung resection with lung cancer had a worse preoperative quality of life compared with the general population. Quality-of-life measures had poor correlation with forced expiratory volume in 1 second, carbon monoxide lung diffusion capacity, and exercise test performance. Therefore, these functional variables cannot substitute for specific evaluation instruments. Finally, patients traditionally considered at higher risk for lung resection had postoperative physical and emotional quality of life scores similar to those observed in younger and fitter patients.
| Introduction |
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The potential benefit (survival) of an operation must be always weighed not only against perioperative morbidity and mortality, but also against residual health-related QOL measures. In fact, more comprehensive and honest patient counseling should include reliable information not only about early outcomes (morbidity and mortality) and long-term survival, but also about the anticipated residual QOL.
The importance of QOL measures is such that future analyses on quality of care evaluation will necessarily take into consideration these endpoints in addition to more traditional measures of performance (morbidity and mortality) [3].
Although the need exists for a more comprehensive understanding of the effects of thoracic surgery on patients functional and QOL outcomes, few studies have recently addressed this subject [1, 4–10]. Only three of them included a preoperative QOL assessment that allowed a comparison with postoperative measures [6, 8, 10], and only two reported norm-based data that may help to clarify what is the physical and emotional condition of patients submitted to lung resection in comparison with normal healthy subjects [6, 9].
Furthermore, most of the studies assessed postoperative QOL 6 months to 5 years after operation [4–6, 9], and this may have excluded the patients not cured by the operation, for whom the knowledge of the residual QOL in the months after surgery may be equally important. Only two studies measured QOL within 3 months after operation [8, 10], presumably reporting a more realistic picture of the physical and emotional status of the entire cohort of patients undergoing lung resection. However, none of these studies used the Short Form 36-Item Health Survey, version 2 (SF36v2).
Thus, the objectives of this prospective study were the following: (1) to assess the postoperative QOL in a consecutive series of patients undergoing major lung resection for lung cancer, by using the SF36v2 preoperatively and at 1 and 3 months after operation (the revised and updated version of SF36v2 has never been used before in lung resection patients and has several advantages over the previous version); (2) to assess the correlation of QOL measures with functional determinants (forced expiratory volume in 1 second [FEV1], carbon monoxide lung diffusion capacity [DLCO], and exercise tolerance) evaluated at the same period; and (3) to verify whether residual QOL differed between patients grouped by age, chronic obstructive pulmonary disease status, sex, presence of coronary artery disease, extent of resection, pulmonary risk, and exercise tolerance.
| Patients and Methods |
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Follow-Up and Quality of Life Measure
Patients were evaluated by pulmonary function test and symptom-limited stair climbing test before the operation (usually 2 to 3 days before surgery) and 1 and 3 months postoperatively. In addition, QOL was measured by administration of the SF36v2, which is a generic QOL instrument that, through a 36-item short form survey, assesses eight health concepts (physical functioning, role limitation caused by physical problems, bodily pain, general health perception, vitality, social functioning, role limitation caused by emotional problems, mental health). Scores standardized to norms and weighted averages are used to create summary physical component scale (PCS) and mental component scale (MCS) scores on a standard scale [11]. The new SF36v2 offers significant measurement improvements over the original SF-36 Health Survey, including corrected deficiencies in the original SF-36 Health Survey, updated population norms, norm-based scoring for all eight scales that makes possible to meaningfully compare scores for eight scale profiles and PCS and MCS on the same graph, substantially increased precision and range of the role-functioning scales, significant enhancements in item wording and format, and less biased estimates of missing responses. The norm-based scoring algorithms introduced for all eight scales employ a linear score transformation, which scores scales that have a mean of 50 and a standard deviation of 10 in the 1998 US general population. The differences in scale scores can more clearly reflect the impact of the disease or treatment. In fact, any score less than 50 falls below the general population mean, and each point represents 1/10th of a standard deviation. General population norms serve as reference points or benchmarks for applications such as estimating disease burden and evaluating treatment benefit.
After completion of the SF36v2 surveys, the patients performed pulmonary function tests and exercise test (symptom-limited stair climbing test) at each evaluation period. Pulmonary function tests were performed according to the American Thoracic Society criteria. The DLCO was measured by the single-breath method. Results of spirometry were collected after bronchodilator administration and were expressed as percentage of predicted for age, sex, and height according to the European Community for Steel and Coal prediction equations [12]. Thoracotomy chest pain at the time of repeat pulmonary function testing was assessed and, if any, controlled by administration of oral analgesics. In all cases, the visual analog scale scores before the pulmonary function tests and repeat exercise tests were kept below 2 (on a scale from 0 to 10).
The stair climbing test was performed as a symptom-limited exercise. Our hospital has 16 flights of stairs, each flight having 11 steps. Each step is 0.155 m in height. The patients were asked to climb, at a pace of their own choice, the maximum number of steps and to stop only for exhaustion, limiting dyspnea, leg fatigue, or chest pain. During the exercise, pulse rate and capillary oxygen saturation were monitored by means of a portable pulse oximeter.
Operative and Postoperative Management
Patients were operated on by qualified thoracic surgeons and were managed in a dedicated thoracic surgery unit. Criteria for inoperability were predicted postoperative FEV1 (ppoFEV1) and predicted postoperative DLCO (ppoDLCO) less than 30% of predicted in association with insufficient exercise tolerance (height at preoperative stair climbing test less than 12 m or VO2max measured at cycle-ergometry less than 10 mL · kg–1 · min–1). As a rule, lung resections were performed through a muscle-sparing lateral thoracotomy. Postoperative management included chest physiotherapy, early as possible mobilization, antibiotic and antithrombotic prohylaxis, and thoracotomy chest pain control by continuous intravenous infusion of ketorolac and tramadol to keep the visual analog scale score below 3 or 4 in the first 72 hours (on a scale from 0 to 10, assessed twice daily).
No formal preadmission or postdischarge physiotherapy or psychological supportive programs were administered.
Statistical Analysis
Normal distribution of SF36v2 scales was tested by the Shapiro-Wilk normality test. Plots of median SF36v2 scales and their confidence intervals were used to explore changes over time. To assess the significance of changes over time, preoperative and repeat postoperative (1 and 3 months) SF36v2 scales were compared by means of repeated measures analyses of variances with adjusted (Games-Howell post-hoc test) pairwise comparisons [13]. Subgroups (stratified by age, chronic obstructive pulmonary disease status, sex, presence of coronary artery disease, DLCO < 70%, ppoFEV1 or ppoDLCO < 40%, extent of operation) comparisons of physical and mental composite scales at 3 months were performed by means of the Mann-Whitney test. In addition, we explored the relationship between SF36v2 physical and mental composite scales and other functional determinants (FEV1, DLCO, exercise tolerance) measured at different evaluation periods (preoperatively and 1 and 3 months postoperatively) using correlation coefficients.
All the statistical tests were two-tailed, with a significance level of p = 0.05, and were performed on the statistical software Stata 8.2 (Stata Corp, College Station, Texas).
| Results |
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| Comment |
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Quality of life is not only an important consideration for those patients achieving long-term survival after curative resection, but even more for those who will experience recurrence months or years after operation. What is the price the patients are ready to pay for a treatment that, although the most efficacious among those available, can not guarantee long-term survival?
Although a need exists for a more comprehensive understanding of the effects of thoracic surgery on patients functional and QOL outcomes, few studies have recently addressed this subject [1, 4–10].
The objective of the present study was to assess the QOL of patients before and after major lung resection for nonsmall-cell lung cancer by using the Short Form-36, version 2 questionnaire. The SF-36 has well-established reliability and has been reported to be sensitive to changes at 1, 6, and 12 months after thoracic surgery for nonsmall-cell lung cancer [14]. The new SF36v2 Health Survey offers significant measurement improvements over the original SF-36 Health Survey. One of the most important improvements is the introduction of norm-based scores for all eight scales that makes possible to meaningfully compare scores for eight scale profiles and PCS and MCS. In this form, the differences in scale scores can more clearly reflect the impact of the disease or treatment. Our study has used this revised version of SF-36 for assessing QOL in lung resection patients.
As all our patients were operated on for lung cancer, we chose the 3-month period as the latest evaluation time with the main intent to limit the drop-out rate. Indeed, at 3 months, 16% of patients operated on during the period of the study dropped out for several reasons (recurrence, adjuvant chemotherapy, refusal to show at follow-up). Concerns over drop-out rates have been reported in other studies [15, 16], which reported drop-out rates as high as 50% at 6 to 12 months after operation. Patients who fail to present at follow-up should presumably be considered the ones in the worse conditions, and prolonging the last evaluation time (ie, 6 or 12 months) could affect the results for a "cream-skimming" effect. Longer-term evaluations including the survivors of lung cancer operations (cured) will be certainly needed to assess the quality of life in this restricted cohort of patients and to see, from their perspective, the price they paid for cure. Nevertheless, in this study, we wanted to include the majority of patients undergoing major lung resections to have a wider picture of their postoperative physical and emotional status and correlate these measures with functional determinants.
We found that candidates for lung resection with lung cancer had many physical and emotional preoperative QOL scales (role limitation caused by physical problems, general health perception, social functioning, role limitation caused by emotional problems, mental health) reduced compared with the general population, confirming previous investigations [6, 9]. In general, these reduced scales remained below norms even 3 months after operation. In fact, 40% to 50% of patients had PCS and MCS scores below norms before and 3 months after the operation. These patients may be the ones to benefit the most of specific program of physical rehabilitation, information, and psychological and social support.
Nevertheless, we found that most of the QOL scales returned to preoperative levels by 3 months. This is in contrast with the findings of Handy and colleagues [6], who reported values of physical functioning, role limitation caused by physical problems, bodily pain, and mental health lower than preoperative scales at 6 months, but confirmed the results of Win and colleagues [8], who showed that global quality of life and several functioning scales had returned to preoperative values by 3 months.
Many studies have examined the residual cardiorespiratory function after lung resection. The unspoken leap of logic in such literature is that decreased functional capacity, as assessed by traditional pulmonary function test and exercise tests, translates to impaired QOL. This assumption would be acceptable only in case QOL scales had a high correlation with traditional functional measures. Unfortunately, we found that physical and mental composite scales had a poor correlation with FEV1, DLCO, and stair climbing performance at each evaluation period. Thus, pulmonary function tests and exercise tests can not be taken as surrogates for QOL evaluation, as discrepancies may exist between patients perception about their residual physical and emotional status and objective functional measures. An ad-hoc instrument should always be used for QOL evaluation.
We then examined whether residual quality of life 3 months after operation was different in groups of patients considered at increased risk compared with lower risk ones. Only those patients undergoing pneumonectomy had lower residual PCS score (but similar MCS score) compared with patients undergoing lobectomy, confirming another study [9]. On the other hand, patients older than 70 years of age, with chronic obstructive pulmonary disease, DLCO lower than 70%, ppoFEV1 or ppoDLCO lower than 40%, and with a coronary artery disease had similar residual PCS and MCS scores at 3 months compared with their lower-risk counterparts. These findings may have great importance during patients counseling before the operation. Patients concerns about their residual QOL should be regarded at least on equal footing with their concerns about perioperative morbidity and mortality and long-term survival. Particularly for patients deemed at higher risk for postoperative major cardiopulmonary complications, the information that residual QOL will be similar to the one experienced by younger and fitter patients may help in their decision to proceed with surgery. This information will be of paramount importance even for the referring physicians, who will be less reluctant to refer high-risk lung cancer patients to surgery.
This study has potential limitations. The first limitation is one common to most of the follow-up analyses and concerns the dropped-out patients. As these patients could have been those in the worst functional status, their inclusion in the analysis could have perhaps changed the results, and that should be taken into account when interpreting the results.
Second, a certain proportion of our patients had adjuvant chemotherapy. As chemotherapy has been proven to impair the gas exchange [17], and may have a detrimental effect both on the physical and emotional status, the inclusion of these patients could have influenced the results. As most of our patients started chemotherapy 4 to 6 weeks after operation, the problem refers mainly to the last evaluation time (3 months). However, only 19 of the 156 patients studied at 3 months underwent adjuvant chemotherapy. We selected to include the 19 patients under chemotherapy after a preliminary analysis that did not show differences in SF36v2 scales at 3 months compared with the other patients.
Quality of life measures reflect the patients perspective and may be affected by several external factors with an emotional impact such as the radicality of the procedure, the degree of satisfaction of received care, and the social support at home, among others. Further analyses are needed to investigate the influence of these factors on the postoperative residual QOL.
In conclusion, we were able to show that candidates for lung resection with lung cancer had reduced preoperative QOL measures compared with general population. Although these measures return to preoperative values by 3 months, many scales still remained below norms. Supportive physical rehabilitation and psychological programs seem indicated for these patients to facilitate and protect their postoperative recovery. We also showed that QOL measures did not correlate well with pulmonary function test and exercise test performance. Therefore, these functional measures can not substitute for specific QOL evaluation instruments. Finally, patients traditionally considered at higher risk for lung resection showed residual physical and emotional status comparable to that observed among younger and fitter patients.
The use of simple questionnaires such as the SF36v2 for assessing the preoperative and postoperative QOL of lung resection candidates should, in our view, be systematically used to provide patients with a reliable estimate of their residual QOL and possibly plan supportive physical and psychological programs.
The results generated in this study need to be confirmed by future prospective investigations, even on a multicentric basis, including also longer-term evaluations.
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