Michael K. Gould, MD, MS; Gillian D. Sanders, PhD; Paul G. Barnett, PhD; Chara E. Rydzak, BA; Courtney C. Maclean, BA; Mark B. McClellan, MD, PhD; Douglas K. Owens, MD, MS
Disclaimer: The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.
Acknowledgments: The authors thank Alan M. Garber, MD, PhD, and James Jett, MD, for reviewing previous versions of this manuscript.
Grant Support: Drs. Gould and Owens received Career Development Awards from the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service. This research was also supported by the Veterans Affairs Cooperative Studies Program, project no. 27: 18-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Michael K. Gould, MD, MS, Pulmonary Section (111P), Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, CA 94304; e-mail, gould@stanford.edu.
Current Author Addresses: Dr. Gould: Pulmonary Section (111P), Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, CA 94304.
Drs. Sanders, McClellan, and Owens and Ms. Rydzak: Center for Primary Care and Outcomes Research/Center for Health Policy, Stanford University, 117 Encina Commons, Stanford, CA 94305-6019.
Dr. Barnett: Veterans Affairs Palo Alto Health Care System, 795 Willow Road (152), Menlo Park, CA 94025.
Ms. Maclean: 2614 Cedar Creek Drive, Durham, NC 27705.
Positron emission tomography (PET) with 18-fluorodeoxyglucose (FDG) is a potentially useful but expensive test to diagnose solitary pulmonary nodules.
To evaluate the cost-effectiveness of strategies for pulmonary nodule diagnosis and to specifically compare strategies that did and did not include FDG-PET.
Decision model.
Accuracy and complications of diagnostic tests were estimated by using meta-analysis and literature review. Modeled survival was based on data from a large tumor registry. Cost estimates were derived from Medicare reimbursement and other sources.
All adult patients with a new, noncalcified pulmonary nodule seen on chest radiograph.
Patient lifetime.
Societal.
40 clinically plausible combinations of 5 diagnostic interventions, including computed tomography, FDG-PET, transthoracic needle biopsy, surgery, and watchful waiting.
Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.
The cost-effectiveness of strategies depended critically on the pretest probability of malignancy. For patients with low pretest probability (26%), strategies that used FDG-PET selectively when computed tomography results were possibly malignant cost as little as $20 000 per QALY gained. For patients with high pretest probability (79%), strategies that used FDG-PET selectively when computed tomography results were benign cost as little as $16 000 per QALY gained. For patients with intermediate pretest probability (55%), FDG-PET strategies cost more than $220 000 per QALY gained because they were more costly but only marginally more effective than computed tomography-based strategies.
The choice of strategy also depended on the risk for surgical complications, the probability of nondiagnostic needle biopsy, the sensitivity of computed tomography, and patient preferences for time spent in watchful waiting. In probabilistic sensitivity analysis, FDG-PET strategies were cost saving or cost less than $100 000 per QALY gained in 76.7%, 24.4%, and 99.9% of computer simulations for patients with low, intermediate, and high pretest probability, respectively.
FDG-PET should be used selectively when pretest probability and computed tomography findings are discordant or in patients with intermediate pretest probability who are at high risk for surgical complications. In most other circumstances, computed tomography-based strategies result in similar quality-adjusted life-years and lower costs.
Table 1. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios for Nondominated Strategies in Patients with Low, Intermediate, and High Pretest Probability of Malignancy
Recommended sequence of diagnostic testing in patients who are at average risk for surgical complications, according to pretest probability and the results of computed tomography (CT).topbottom
Suggested algorithm for clinical management of patients with solitary pulmonary nodules who are at average risk for surgical complications.CT
Table 2. Recommendations on the Use of Computed Tomography, Positron Emission Tomography with 18-Fluorodeoxyglucose, Watchful Waiting, Transthoracic Needle Biopsy, and Surgery
Decision model.ACTFDG-PETBCD
Decision model subtrees.
Appendix Table 2. Alternative Strategies for Management of Patients with Solitary Pulmonary Nodules
Markov model.
Observed and modeled survival for patients with local, regional, and distant lung cancer.SEER
Distribution of tumor doubling times and corresponding probabilities of disease progression during the observation period.black circles
Appendix Table 3. MEDLINE Search for Studies of Positron Emission Tomography with 18-Fluorodeoxyglucose
Appendix Table 4. Studies of Positron Emission Tomography with 18-Fluorodeoxyglucose for Pulmonary Nodule Diagnosis
Summary receiver-operating characteristic (ROC) curve for positron emission tomography with 18-fluorodeoxyglucose (FDG-PET).dotted linesblack squareblack circle
Appendix Table 5. Studies of Computed Tomography Densitometry for Diagnosis of Pulmonary Nodules and Mass Lesions
Appendix Table 6. Studies of High-Resolution Computed Tomography for Pulmonary Nodule Diagnosis
Appendix Table 7. Studies of Dynamic Computed Tomography with Nodule Enhancement
Summary receiver-operating characteristic (ROC) curve for computed tomography (CT).dotted lines
Appendix Table 8. Studies of Computed TomographyGuided Needle Biopsy for Pulmonary Nodule Diagnosis
Health care costs for patients with malignant pulmonary nodules.black circlesblack squaresblack triangles
Recommended sequence of diagnostic testing in patients who are at average risk for surgical complications, according to pretest probability, computed tomography (CT) results, and threshold that determines cost-effectiveness.QALYPET
Recommended sequence of diagnostic testing in patients who are at high risk for surgical complications, according to pretest probability, computed tomography (CT) results, and threshold that determines cost-effectiveness.FDG-PETQALY
Appendix Table 9. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios in Patients with Low Pretest Probability (26%) and Average Risk for Surgical Complications
Appendix Table 10. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios in Patients with Low Pretest Probability (26%) and High Risk for Surgical Complications
Appendix Table 11. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios in Patients with Intermediate Pretest Probability (55%) and Average Risk for Surgical Complications
Appendix Table 12. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios in Patients with Intermediate Pretest Probability (55%) and High Risk for Surgical Complications
Appendix Table 13. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios in Patients with High Pretest Probability (79%) and Average Risk for Surgical Complications
Appendix Table 14. Expected Costs, Quality-Adjusted Life-Years, and Incremental Cost-Effectiveness Ratios in Patients with High Pretest Probability (79%) and High Risk for Surgical Complications
Selective use of FDG-PET imaging for pulmonary nodule diagnosis represents a good value for the health care dollar relative to other commonly accepted medical and public health interventions.
Dissemination of FDG-PET imaging for diagnosis of pulmonary nodules is worthwhile based on efficiency criteria.
Current policies that deny reimbursement for needle biopsy after FDG-PET should be reconsidered. When FDG-PET results are negative, it is usually more effective to perform needle biopsy rather than watchful waiting, except when pretest probability is very low.
Computed tomography with dynamic contrast enhancement seems to be a promising alternative to FDG-PET that warrants further study. It seems to be most cost-effective when used selectively in patients with low to intermediate pretest probability who have possibly malignant results on noncontrast CT.
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Gould MK, Sanders GD, Barnett PG, Rydzak CE, Maclean CC, McClellan MB, et al. Cost-Effectiveness of Alternative Management Strategies for Patients with Solitary Pulmonary Nodules. Ann Intern Med. ;138:724–735. doi: 10.7326/0003-4819-138-9-200305060-00009
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© 2019
Published: Ann Intern Med. 2003;138(9):724-735.
DOI: 10.7326/0003-4819-138-9-200305060-00009
Healthcare Delivery and Policy, Hematology/Oncology, Lung Cancer, Pulmonary/Critical Care.
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