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NEJM -- National Emphysema Treatment Trial Research Group. A Randomized Trial Comparing Lung-Volume–Reduction Surgery with Medical Therapy for Severe Emphysema. N Engl J Med 2003;348(21):2059-73 -- Supplementary Appendixes

View PDF of Supplementary Appendixes 1-8 or link to individual appendixes below.


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Supplementary Appendix 1. Criteria for Inclusion and Exclusion.*


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Supplementary Appendix 1. (Continued.)


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Supplementary Appendix 2. Sensitivity Analysis of Sex-Specific Cutoff Points for Subgroups Defined According to Maximal Workload.

Graph shows the risk ratio (lung-volume–reduction surgery [LVRS] vs. medical therapy) for percentile cutoff points of base-line maximal workload, ranging from the 10th percentile to the 70th percentile in 5-percentile steps. The cutoff points for a given patient vary according to sex; for example, the 40th percentile for base-line maximal workload for women was 25 W, whereas the 40th percentile for men was 40 W. This graph suggests the 40th percentile of base-line maximal workload as the cutoff point beyond which the risk ratio increases.


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Supplementary Appendix 3. Postrehabilitation Base-Line Characteristics of Non–High-Risk Patients.*


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Supplementary Appendix 4. Histograms of Changes from Postrehabilitation Base Line in Exercise Capacity (Maximal Workload), Percentage of Predicted Value for Forced Expiratory Volume in One Second (FEV1), Distance Walked in Six Minutes, Health-Related Quality of Life (St. George’s Respiratory Questionnaire), Quality of Life (Quality of Well-Being Scale), and Dyspnea (UCSD Shortness of Breath Questionnaire) after 6, 12, and 24 Months of Follow-up.

The category “missing” includes patients who were too ill to complete the procedure or who declined to complete the procedure but did not explain why. For the Quality of Well-Being scale, patients who died were assigned a score of 0 on the questionnaire for the visit, and patients who did not complete the questionnaire were assigned a score equal to half of the lowest score observed for the visit. P values were determined by the Wilcoxon rank-sum test. The degree to which the bars are shifted to the upper left of the chart indicates the degree of a relative benefit of lung-volume–reduction surgery (LVRS) over medical treatment. The percentage shown in each quadrant is the percentage of patients in the specified treatment group with a change in the outcome falling into that quadrant. This was an intention-to-treat analysis.


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Supplementary Appendix 5. Patient’s Place of Residence According to the Time since Randomization.*


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Supplementary Appendix 5. (Continued.)


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Supplementary Appendix 6. Histograms of Changes from Postrehabilitation Base Line in Distance Walked in Six Minutes, Health-Related Quality of Life (St. George’s Respiratory Questionnaire), and Dyspnea (UCSD Shortness of Breath Questionnaire) after 6, 12, and 24 Months of Follow-up.

High-risk patients were excluded. The category “missing” includes patients who were too ill to complete the procedure or who declined to complete the procedure but did not explain why. P values were determined by the Wilcoxon rank-sum test. The degree to which the bars are shifted to the upper left of the chart indicates the degree of relative benefit of lung-volume–reduction surgery (LVRS) over medical treatment. The percentage shown in each quadrant is the percentage of patients in the specified treatment group with a change in the outcome falling into that quadrant. High-risk patients had an FEV1 that was 20 percent or less of the predicted value and either homogeneous emphysema or a carbon monoxide diffusing capacity that was 20 percent or less of the predicted value. This was an intention-to-treat analysis.


View Figure
Supplementary Appendix 7. Box Plots of Changes from Postrehabilitation Base Line in Exercise Capacity (Maximal Workload), Percentage of the Predicted Value for Forced Expiratory Volume in One Second (FEV1), Distance Walked in Six Minutes, Health-Related Quality of Life (St. George’s Respiratory Questionnaire), General Quality of Life (Quality of Well-Being Scale), and Dyspnea (UCSD Shortness of Breath Questionnaire), among Patients who Completed the Procedure after 6, 12, or 24 Months of Follow-up.

High-risk patients were excluded. Solid boxes represent patients assigned to lung-volume–reduction surgery (LVRS); open boxes represent patients assigned to medical therapy. The line inside each box indicates the median value, the top and bottom of each box indicate the 1st and 3rd quartiles, and the tails of the boxes extend to the most extreme values not considered to be outliers. Values outside the tails of the box plot are considered to be outliers. High-risk patients had an FEV1 that was 20 percent or less of the predicted value and either homogeneous emphysema or a carbon monoxide diffusing capacity that was 20 percent or less of the predicted value. This was not an intention-to-treat analysis, since it was limited to surviving patients.


View Figure
Supplementary Appendix 8. Histograms of Changes in Health-Related Quality of Life (St. George’s Respiratory Questionnaire) after 6, 12, and 24 Months of Follow-up among Subgroups of Non–High-Risk Patients.

The category "missing" includes patients who were too ill to complete the procedure or who declined to complete the procedure but did not explain why. P values were determined by the Wilcoxon rank-sum test; the degree to which the bars are shifted to the upper left of the chart indicates the degree of relative benefit of lung-volume–reduction surgery (LVRS) over medical treatment. The percentage shown in each quadrant is the percentage of patients in the specified treatment group with a change in outcome falling into that quadrant. High-risk patients had a forced expiratory volume in one second that was 20 percent or less of the predicted value and either homogeneous emphysema or a carbon monoxide diffusing capacity that was 20 percent or less of the predicted value. Low base-line exercise capacity was defined as a maximal workload at or below the sex-specific 40th percentile (25 W for women, 40 W for men); high exercise capacity was defined as a workload above this threshold. This was an intention-to-treat analysis.





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