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* From the Division of General Internal Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill (Dr. Cykert), the Internal Medicine Program and Area Health Education Center of The Moses Cone Health System (Dr. Cykert and Mr. Hansen), Greensboro, and the Department of Mathematics (Dr. Kissling), University of North Carolina at Greensboro, Greensboro, NC.
Correspondence to: Samuel Cykert, MD, Department of Medicine (University of North Carolina), Internal Medicine Program, The Moses H. Cone Memorial Hospital, 1200 N. Elm St, Greensboro, NC 27401; e-mail scyker@med.unc.edu
| Abstract |
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Objective: To assess patients preferences regarding possible outcomes of lung resection, including traditional complications reported in the lung surgery literature and outcomes that describe functional limitation.
Design: Utility analysis.
Setting: A community hospital internal medicine clinic, a private internal medicine practice, and a private pulmonary practice.
Participants: Sixty-four patients, aged 50 to 75 years, who were awaiting appointments at the designated clinic sites.
Main outcome measure: Patients strength of preference regarding potential outcomes of lung resection as derived from health utility scores.
Results: Common postoperative complications were assigned high utility scores by patients. On a scale for which 1.0 represents perfect health and 0 represents death, postoperative atelectasis, pneumonia, and 3 days of mechanical ventilation were all rated >0.75. Scores describing limited physical function were strikingly low. Specifically, activity limited to bed to chair movement and the need for complete assistance with activities of daily living were all assigned utility scores <0.2. Twenty-four-hour oxygen dependence was scored at 0.33. Presence or absence of pulmonary illness did not predict scores for any outcome.
Conclusions: Whether patients suffer from chronic lung disease or not, they do not regard the postoperative outcomes reported in the lung surgery literature as sufficiently morbid to forego important surgery. However, physical debility is perceived as extremely undesirable, and anticipation of its occurrence could deter surgery. Therefore, identification of preoperative predictors of postoperative physical debility would be invaluable for counseling patients who face difficult decisions about lung resection.
Key Words: lung surgery outcomes physical function utilities
| Introduction |
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Many studies have attempted to identify preoperative variables that can predict postoperative morbidity for patients undergoing lung resection.
Techniques such as measurement of diffusion capacity,1 2 3 4 5 prediction of postoperative FEV1,1 2 6 7 and assessment of preoperative exercise capacity have been shown to identify individuals more apt to experience postoperative complications.8 9 10 11 12 13 The common complications evaluated in these trials include postoperative pneumonia, atelectasis, mechanical ventilation of > 24 to 48 h duration, and myocardial infarction. Although such outcomes may lead to longer hospital stays and additional costs,5 it is unclear whether the way patients perceive these complications would lessen acceptance of the surgical option. Therefore, identifying predictors of these common complications may not enhance preoperative decision making from the patients perspective.
Possible consequences of lung resection that patients might regard as important include oxygen dependence, varying degrees of poor exercise tolerance, and inability to perform activities of daily living. Therefore, the purposes of this study were to assess patients preferences regarding postoperative outcomes that have been traditionally reported in the lung resection literature and to compare these preferences to those that describe outcomes of limited physical function. Such a comparison would help identify the postoperative outcomes that patients are least willing to risk and for which reliable preoperative predictors would most influence their surgical decisions.
| Materials and Methods |
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Participating patients were given a structured questionnaire using the standard gamble technique.15 In this technique, the patient is guaranteed an intermediate health state, then offered an intervention that can convert the intermediate health state to perfect or normal health or to immediate death. In our study, the emphasis was on the return of the patient to his or her own normal health. The patient is asked to express the risk of death that he or she is willing to take to avoid the intermediate health state and achieve normal health. The point at which the patient becomes indifferent to the risk of dying compared with life in the intermediate health state conveys a value for that intermediate state. For example, if the patients choice is ambivalent between taking a 20% risk of dying to achieve normal health as opposed to accepting the certainty of an intermediate health state, then the utility assigned to that intermediate state is 0.8. The higher the risk of death the patient is willing to accept to achieve normal health and avoid the intermediate state, the lower the value that person places on the intermediate state.
The questionnaire, through the presentation of hypothetical scenarios, was designed to measure the strength of preferences that patients assign to potential outcomes of lung surgery. Standard gamble scenarios were used to describe life with lung cancer, traditional outcomes in lung surgery literature such as atelectasis, pneumonia, and prolonged mechanical ventilation,3 6 8 9 10 13 16 17 18 and specific limitations of physical function. The functional states of interest in this study included reductions in walking distance, mobility limited to bed to chair, restrictions of activities of daily living, oxygen dependence, mandatory nursing home placement, and permanent ventilator dependence. The entire questionnaire is presented in the Appendix. Visual and verbal cues were provided initially to explain the relationship between percentages and risk. The interviewer then read the scenarios from a script. After each scenario, the patient, without further prompting, was allowed to express the risk of immediate death that he or she would accept to undergo a therapy that would restore normal health and avoid the guaranteed intermediate state described. After the utility assessment portion of the questionnaire was completed, demographic information was obtained including age, sex, race, education, marital status, health insurance coverage, and self-rated health.
Statistical Analysis
Statistical analysis was performed using both SPSS (Chicago, IL)
and SAS (SAS Institute; Cary, NC) software. Utility scores
ranged from 1.0 for perfect health to 0 for death. Standard gamble data
were converted to utility scores by subtracting the equilibrium risk
between death and the intermediate outcome from 1.0 as described by
Torrance et al15
and Nord.19
Descriptive
statistics were calculated for each set of utility scores and
demographic categories. Because the standard gamble results were not
normally distributed, Mann-Whitney U tests were performed to
identify bivariate predictors. Kruskal-Wallis one-way analysis of
variance was used if the predictor variable had more than two
categories. Stepwise nonparametric regression analysis was then
performed for each outcome variable using demographic data and the
presence or absence of pulmonary illness as predictor variables.
Bootstrapping techniques were used, post hoc, to determine
the power of detecting a regression slope at
= 0.05.
Bootstrapping is a resampling method that is particularly useful for
estimation and inference on small nonnormally distributed data sets.
For our purposes, the sampling distribution of the regression slope was
generated from 1,000 resamplings of the sample. Then, the power of the
test was estimated as the proportion of the sampling distribution for
which the null hypothesis would be rejected.20
| Results |
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Significant bivariate associations are reported in Table 3
. Regarding the commonly reported postoperative outcomes, lower
self-rated health predicted lower utility scores for atelectasis,
pneumonia, and mechanical ventilation lasting
3 days. Interviews of
individuals experiencing pulmonary illness did not yield significant
differences in utility scores for any outcome presented except for
those pertaining to mechanical ventilation. However, when demographic
data, self-rated health, and pulmonary illness were placed in
multivariable models with utility scores for mechanical ventilation as
the outcome variables, pulmonary illness dropped out as a predictor
variable, whereas age and self-rated health were retained for all
durations of mechanical ventilation. Advancing age and poorer
self-rated health also remained as predictors of reduced utility scores
for postoperative atelectasis, whereas only poorer self-rated health
predicted lower scores for postoperative pneumonia. Patient sex was a
weak predictor of attitudes toward oxygen dependence and myocardial
infarction, whereas level of education did not predict any utility
score differences. Findings of the multiple regression analysis are
summarized in Table 4
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Given the sample size of 64 and an
= 0.05, the bootstrapped
estimate of the power to detect variables other than those already
entered into the stepwise regression models was
78% for all
outcome variables (Table 4)
.
| Discussion |
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O2max) < 10 to 15
mL/kg/min, as measured by exercise testing, have a higher postoperative
mortality risk compared with other patients.2
8
9
In the
study by Markos et al,2
3 of 6 patients with a
postoperative FEV1 < 40% of predicted
died as compared with 0 of 49 in the group with higher
FEV1. Bechard and Wetstein8
reported
two deaths in 7 patients with preoperative
O2max < 10 mL/kg/min
compared with two deaths in 50 patients with higher
O2max, and Smith and
colleagues9
documented three deaths in 6 patients with
O2max < 15 mL/kg/min vs one
death in 16 patients in the group with higher
O2max. However, for surgical
survivors who are thought to be borderline surgical candidates as
defined by the above criteria, to our knowledge there are no reports
describing postoperative functional status, and it is unknown whether
these specific patients consider their experience worth it. A recent
large prospective study performed at Veterans Affairs Medical Centers
identified pneumonectomy compared with lobectomy (11.5% vs 4.0%) as a
strong predictor of 30-day postoperative mortality.26 Other studies that attempt to identify high-risk patients do not confine the definition of complications to death or a well-defined fixed morbidity. Instead, these reports use a composite outcome consisting of an amalgamation of complications, including postoperative pneumonia, atelectasis, and need for mechanical ventilation > 24 h.1 2 3 4 5 6 7 8 9 10 11 13 16 17 18 This composite outcome is then used to identify predictors of high-risk patients, presumably to inform physicians and patients that lung surgery for these individuals may need to be reconsidered.
In our study, we demonstrated that patients assign high utility scores to the postoperative complications that make up the composite outcomes in the lung resection literature. Given this result, the occurrence of pneumonia, atelectasis, and prolonged mechanical ventilation would not likely be considered sufficiently deleterious to deter patients from lung resection. However, patients assign extremely low utility scores to states of physical debility. These scores represent a perceived quality of life so poor that many patients might forego surgery if permanent debility states could be reliably predicted in the preoperative period.
Several attempts have been made to measure quality of life and exercise capacity after lung resection, and the results are mixed. A retrospective study by Bousamra et al4 noted that a lower-than-expected diffusion capacity would identify patients who were more likely to be oxygen dependent postoperatively, but the results were confounded by more pneumonectomy procedures and greater use of radiation therapy in the oxygen-dependent group. In a prospective series reported by Wang and colleagues,5 6 of 40 patients experienced postoperative oxygen dependence despite a mean preoperative FEV1 of 2 L. This study identified diffusion capacity as a predictor of an amalgamated outcome of 30 pulmonary complications; therefore, no specific predictor for oxygen dependence was identified. A group led by Dales et al27 measured quality of life in 117 patients undergoing lung resection using the clinical dyspnea index, the pneumoconiosis research unit index, the QL-index, and the sickness impact profile.27 They found that dyspnea was worse and activities of daily living were more restricted up to 3 months postoperatively, but returned to baseline at 6 months. The data in their study are not particularly useful for individuals with significant pulmonary impairment or those requiring more extensive lung surgery, as the mean preoperative FEV1 for participants was 2.2 L and only 15 patients underwent pneumonectomy. Also, given that 20% of participants were unavailable for follow-up 3 months after surgery and 54% at 9 months, it is possible that patients who were agreeable to follow-up were less ill than those who avoided it, creating a bias toward higher quality-of-life scores. Using the SF-36, Mangione and associates28 demonstrated declines in perceived quality of life after lung surgery. Twelve months later, health perceptions of surgical patients were not statistically different when compared with an age-matched general population. Again, preoperative pulmonary function and extent of resection were not accounted for separately. Four reports demonstrated conclusively that lobectomy patients experience little or no persisting reductions in exercise capacity after their operations, and pneumonectomy patients experience reductions of 16 to 30%.21 29 30 31 None of these authors, however, correlated patients exercise data with actual daily activity, nor did they stratify these analyses according to patients perceptions of their quality of life. In summary, although studies are available that describe quality-of-life issues, predictors of debility, and other poor outcomes have gained little attention, especially for pulmonary patients suffering greater impairment.
Possible limitations of this study include small sample size and the potential of wide variation of utility scores among individuals or groups. To address these issues, each utility score was reported with 95% CIs. Using only 64 study subjects and the extremes of the 95% CI, the gap between patients values for the traditional outcomes in the lung surgery literature and the outcomes of physical debility remained wide. Although CIs helped define the degree of variability among individuals, bivariate and multiple regression analyses were performed to account for variation between groups. The bootstrap calculations revealed that the regression models possessed adequate power to detect predictor variables other than those actually identified.
It must be noted that by using standard measurements of health utility scores, we assigned patient preferences to potential outcomes of lung surgery. Although we have identified outcomes more likely to create substantial mathematical impact on a formal decision model when compared with the common outcomes cited in the lung surgery literature, these data do not, if used in a vacuum, identify patients who should or should not undergo surgery. Even if outcomes of physical debility could be predicted reliably, the surgical decision would be influenced by many variables, including the likelihood of a lung cancer diagnosis as opposed to a benign diagnosis, the extent of anticipated surgery (wedge resection vs lobectomy vs pneumonectomy), the perioperative mortality risk, the patients age, the probability of surgical cure, the need for other potentially debilitating treatments, eg, radiation or chemotherapy, and an estimate of long-term survival based on the patients age and comorbidities. If the decision model were constructed from a cost-effectiveness viewpoint (the likely approach of a payer rather than a patient), the traditionally studied outcomes of atelectasis, pneumonia, and protracted ventilator therapy would assume greater importance. Although these complications do not affect the expected utilities of patients, they can prolong hospitalizations and require therapies that add to the cost of care.5
In conclusion, through the assessment of health utility scores, patients, including those who suffer from chronic lung disease, express significant concern about experiencing outcomes of limited physical function. These same patients are hardly affected by the specter of transient atelectasis, pneumonia, and mechanical ventilation. From the patients perspective, the decision for surgery hinges on preoperative prediction of outcomes, such as nursing home placement, oxygen dependence, restrictions in ambulation, and limitations in performance of activities of daily living. Ironically, the lung surgery literature regularly highlights predictors of transient states. If patients are to understand their true operative risk, future investigations must focus on identifying clinical and physiologic predictors of fixed functional outcomes.
| Appendix 1 |
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2. You have a lung disease that causes you to be short of breath to the point of needing to stop after walking two city blocks. A treatment has been invented that will correct your lung problem and allow you to breathe normally during the remainder of your life (substitute appropriate life expectancy); however, with the treatment there is a risk of dying immediately. In other words, without treatment you are guaranteed to live the rest of your life but with the activity limitation of two blocks of walking as mentioned. What percent risk of dying right now would you take to receive a treatment that would restore your breathing and activity level to normal for the remainder of your life?
3. A small part of your lung has become plugged with mucus and collapses, causing you to experience some mild discomfort and shortness of breath while simply resting. After 5 days of no improvement, a light (or bronchoscope) is passed through your mouth, down your throat, and into your lung to suction out the mucus and reexpand the lung. A treatment could be available on day 1 that would have avoided the need for the light and relieved your symptoms right away. However, there is a risk of dying on day 1 because of the treatment. In other words, if you do not take the new treatment, you would be guaranteed to breathe normally after 5 days and the bronchoscope procedure. What percent risk of dying right now would you take to receive the treatment and avoid these 5 days of discomfort?
4. You have just been diagnosed with pneumonia. You could either stay in the hospital for 2 weeks receiving IV antibiotics and oxygen, and being confined to just a few steps while walking around your room, or you could receive a special treatment that cures the pneumonia right now and immediately returns you to your baseline health. The problem with the special treatment is that it occasionally can cause immediate death. In other words, without the treatment, you would be guaranteed to return to your original state of health after suffering through 2 weeks of the pneumonia illness. What percent risk of dying right now would you take to avoid the 2 weeks of pneumonia as above?
5. It has been discovered that you have circulation problems in your heart and that if you are not treated right away, you will surely suffer a heart attack. The problem with the treatment is that there is a risk of dying at the time of the treatment. In other words, without the treatment, you would be guaranteed suffering a heart attack but surviving. What percent risk of dying right now would you take to receive treatment that would prevent your heart attack?
6. You have developed an illness in which your lungs have filled with fluid, and you are dependent on a breathing machine (mechanical ventilator) to breathe. In a situation like this, you would be constantly lying on your back, you would be connected to a ventilator by a tube placed in your throat, the presence of which will not allow you to speak, and you would have multiple IV lines in your arms that would result in at least one needle stick per day. With usual therapy, it is certain that you will be disconnected from the breathing machine in 3 days. There is a special treatment available that would cure your illness immediately. However, there is a small risk of immediate death when this treatment is used. In other words, if you did not take the treatment, you would be guaranteed to recover after spending 3 days attached to the ventilator as above. What percent risk of dying right now would you be willing to take to be cured immediately as opposed to spending 3 days connected to the ventilator?
7. You have developed an illness in which your lungs have filled with fluid, and you are dependent on a breathing machine (mechanical ventilator) to breathe. In a situation like this, you would be constantly lying on your back, you would be connected to a ventilator by a tube placed in your throat, the presence of which will not allow you to speak, and you would have multiple IV lines in your arms that would result in at least one needle stick per day. With usual therapy, it is certain that you will be disconnected from the breathing machine in 7 days. There is a special treatment available that would cure your illness immediately. However, there is a small risk of immediate death when this treatment is used. In other words, if you did not take the treatment, you would be guaranteed to recover after spending 7 days attached to the ventilator as above. What percent risk of dying right now would you be willing to take to be cured immediately as opposed to spending 7 days connected to the ventilator?
8. You have developed an illness in which your lungs have filled with fluid, and you are dependent on a breathing machine (mechanical ventilator) to breathe. In a situation like this, you would be constantly lying on your back, you would be connected to a ventilator by a tube placed in your throat, the presence of which will not allow you to speak, and you would have multiple IV lines in your arms that would result in at least one needle stick per day. With usual therapy, it is certain that you will be disconnected from the breathing machine in 15 days. There is a special treatment available that would cure your illness immediately. However, there is a small risk of immediate death when this treatment is used. In other words, if you did not take the treatment, you would be guaranteed to recover after spending 15 days attached to the ventilator as above. What percent risk of dying right now would you be willing to take to be cured immediately as opposed to spending 15 days connected to the ventilator?
9. You have developed an illness in which your lungs have filled with fluid, and you are dependent on a breathing machine (mechanical ventilator) to breathe. In a situation like this, you would be constantly lying on your back, you would be connected to a ventilator by a tube placed in your throat, the presence of which will not allow you to speak, and you would have multiple IV lines in your arms that would result in at least one needle stick per day. With usual therapy, it is certain that you will be disconnected from the breathing machine in 30 days. There is a special treatment available that would cure your illness immediately. However, there is a small risk of immediate death when this treatment is used. In other words, if you did not take the treatment, you would be guaranteed to recover after spending 30 days attached to the ventilator as above. What percent risk of dying right now would you be willing to take to be cured immediately as opposed to spending 30 days connected to the ventilator?
10. Imagine that you suffer from a lung illness that causes you to be so short of breath that you cannot dress, brush your teeth, bathe, or groom without assistance. This condition will last the rest of your life unless you undergo a corrective treatment. The treatment would return you to health immediately, but there also exists an immediate risk of dying with the treatment. In other words, if you did not take the treatment, you would be guaranteed living the rest of your life needing help to complete the tasks of bathing, dressing, and grooming. What percent risk of dying right now would you be willing to take to receive a treatment that would cure the breathing limitations mentioned and restore breathing and activities to normal?
11. Imagine that you have an illness so severe that sitting in a chair for 5 min makes you extremely short of breath and all you can do is sit periodically then lie in bed the rest of the time. This condition is permanent unless you receive a treatment that, if successful, will cure you immediately. The problem with the treatment is that it could also cause immediate death. In other words, if you do not take the treatment, you are guaranteed survival but you would be confined to bed with occasional 5-min breaks in a chair. What percent risk of dying right now would you be willing to take to receive a treatment and cure your condition to avoid this bed to chair existence?
12. You have a long-term lung disease that requires you to wear an oxygen mask at all times including during sleep. You are able to eat, drink, bathe, and dress yourself while wearing your oxygen mask. A small portable oxygen tank allows you to walk, but your lung disease causes you to become short of breath after walking one or two rooms of your house. There is a treatment that will correct your lung problem and allow you to breathe normally during the remainder of your life (adjusted life expectancy). There is some risk of immediate death when this treatment is used. In other words, if you do not take the treatment, you are guaranteed surviving your normal life expectancy except you would be dependent on oxygen to breathe as described. What percent risk of dying right now would you be willing to take to receive a treatment that restores your breathing to normal for the remainder of your life?
13. You have a long-term lung disease and have recently been hospitalized with pneumonia. You recover from the illness, but the prolonged hospitalization leaves you too weak to return home. After hospital discharge, you will reside in a nursing home for 1 month. While in the nursing home, you will share a room with another resident and eat meals either in your room or in a communal dining area. Initially, you will need the assistance of a wheelchair, but with physical therapy treatments, you will eventually walk on your own. Any activity outside the nursing home must be approved by your physician. On your return home, you are only able to walk one block before becoming short of breath. A treatment is available that will correct your lung problem, but it is associated with some risk of not surviving the treatment course. In other words, if you did not take the treatment, you would be guaranteed a month of slow recovery in a nursing home, with the living situation as noted above, followed by living the rest of your life short of breath to the extent of being able to walk only one block at a time. What percent risk of dying right now would you take to avoid these consequences and restore your breathing to normal?
14. You have a long-term lung disease that has progressed to the point where your baseline activity has been reduced by 50%. For example, if you were previously able to walk 10 blocks before becoming short of breath, your lung disease currently limits you to walking only 5 blocks. A treatment has been invented that will correct your lung problem and allow you to breathe normally during the remainder of your life. There is some risk of immediate death when this treatment is used. In other words, if you do not take the treatment, you are guaranteed survival, but only at half the capacity that you function now. What percent risk of dying right now would you be willing to take to receive the treatment and maintain your full breathing and functional capacity?
15. You have a long-term lung disease that has progressed to the point where you or your family are no longer able to care for your physical and health needs at home. You now live in a nursing home where you will reside permanently. While in the nursing home, you will share a room with another resident and eat meals either in your room or in a communal dining area. Initially, you will need the assistance of a wheelchair, but with physical therapy treatments you will eventually walk on your own, but not well enough to return to your home. A treatment is available that will correct your lung problem and allow you to breathe normally and live at home. In other words, if you do not take the treatment, you are guaranteed survival, but will be confined to a nursing home the remainder of your life. What percent risk of dying right now would you take to go through with the treatment so that you would recover and return to your home?
16. You have a long-term lung disease and have been in the hospital for the last 2 months recovering from pneumonia. The severity of your lung disease requires use of a breathing machine to allow you to breathe. You are connected to a ventilator by a tube placed in your throat that does not allow you to speak or eat, and you will have multiple IV lines in your arms that would result in at least one needle stick per day. You will remain on the breathing machine for the next 6 months and then you will die. A treatment is available that will correct your lung problem and allow you to be disconnected from the breathing machine and restore normal breathing. There is some risk of immediate death with this treatment. In other words, if you do not take the treatment, you are guaranteed being attached to a breathing machine for 6 months, then dying. What percent risk of dying right now would you take to avoid 6 months connected to the breathing machine followed by death to take a treatment that would restore your breathing to normal?
Demographic Data
1. Age
2. Education
3. Race
4. Marital status
5. Health insurance status (none, Medicaid, Medicare, private)
6. Sex
7. I consider my overall health to be
(1) very poor (2) poor (3) average (4) good (5) very good
| Acknowledgements |
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| Footnotes |
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O2max = maximal oxygen consumption Presented, in part, at the national meeting of the Society of General Internal Medicine, Washington, DC, May 3, 1997.
Supported by the Education Committee of the Moses Cone Health System.
Received for publication July 2, 1999. Accepted for publication December 29, 1999.
| References |
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