Misuse of RAI therapy in papillary thyroid microcarcinomas in academic/research programs, comprehensive community programs, and community programs.
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Goffredo P, Thomas SM, Dinan MA, Perkins JM, Roman SA, Sosa JA. Patterns of Use and Cost for Inappropriate Radioactive Iodine Treatment for Thyroid Cancer in the United States: Use and Misuse. JAMA Intern Med. 2015;175(4):638–640. doi:10.1001/jamainternmed.2014.8020
Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
Based on current guidelines, adjuvant radioactive iodine (RAI) therapy is not recommended for localized papillary thyroid tumors measuring 1 cm or less, medullary thyroid cancer (MTC), and anaplastic thyroid cancer (ATC).1-3 Nevertheless, previous studies have reported the use of RAI in the treatment of these cancers.
The aim of the current study was to analyze patterns of inappropriate RAI use in the United States to identify potential misuses leading to increased costs for the health care system and unnecessary patient exposure to the risk and potential complications of RAI therapy.4
The National Cancer Data Base was used to identify patients diagnosed with ATC, MTC, and papillary thyroid cancer from 1998 to 2011.5 The Surveillance, Epidemiology, and End Results database was used to cross-validate the National Cancer Data Base patient population.6 The study was granted exempt status by the Duke University Institutional Review Board. Patient consent was not obtained as it was not necessary.
All adult patients with ATC and MTC were included in the analyses. Inclusion criteria for patients with papillary thyroid cancer were the following: papillary thyroid microcarcinoma (PTMC) measuring 1 cm or less, no aggressive histologic variants, no extrathyroidal extension, no regional or distant metastases, and negative margin status.
Estimates of costs were obtained from the 2011 and 2014 Medicare reimbursement schedule and from the US Bureau of Labor Statistics (Table). Costs were estimated only for PTMCs.
In the National Cancer Data Base, 49 of 3095 ATCs (1.6%), 217 of 6375 MTCs (3.4%), and 14 146 of 60 586 PTMCs (23.3%) were inappropriately treated with RAI.
In univariate analyses, patients with ATCs who received RAI were younger than those who did not (P < .001), had lower income (P = .01), were from a rural or urban rather than a metropolitan county (P = .04), and had smaller tumors (P = .001). Patients with MTCs whose management included RAI were less likely to be treated in academic facilities (P < .001) and had smaller tumors (P = .02).
Patients with PTMCs treated with RAI were younger, more often white, managed in nonacademic centers, and were more likely to have multifocal and larger tumors (all P < .001). While the overall incidence of PTMC significantly increased over time, the proportion of PTMCs treated with RAI has decreased. When stratified by facility type, the rate of RAI administration showed no change in community hospital programs (P = .26) but decreased at comprehensive and academic hospital programs (P < .001) (Figure).
In adjusted analyses, inappropriate RAI therapy was associated with Hispanic origin, low income, receiving care in nonacademic facilities, tumor multifocality, and increasing size. Protective factors included older age, black and other races, more recent year of diagnosis, no insurance or government insurance, and receiving less than a total thyroidectomy.
The average cost per patient ranged between $5587.73 and $8442.11 in 2011 US dollars and $5429.58 and $9105.67 in 2014 US dollars. The average total number of patients was 1768 per year, with a total cost of $9 879 109 to $14 925 650 per year in 2011 US dollars and $9 599 497 to $16 098 824 per year in 2014 US dollars.
To our knowledge, this is the first study to demonstrate that 23.3% of PTMCs, 3.4% of MTCs, and 1.6% of ATCs undergo unnecessary adjuvant RAI therapy, with an estimated cost burden of $9 599 497 to $16 098 824 per year for PTMC management alone. This cost is likely an underestimation given the fact that we could not include costs associated with complications from RAI therapy and quality of life changes and that our reported costs are based on Medicare reimbursements, which are lower than private insurance rates.
In our cohort, the rate of unnecessary RAI treatment decreased overall; however, no change was observed during the past decade at community hospitals. This emphasizes the need to educate health care professionals regarding evidence-based practice guidelines and disseminate those guidelines in areas that may serve vulnerable populations.
In conclusion, our study demonstrates that nearly one-fourth of patients with thyroid cancer may receive unnecesary RAI treatment. Ongoing efforts should be undertaken to educate health care professionals in the appropriate use of RAI therapy to optimize patient care.
Corresponding Author: Sanziana A. Roman, MD, Section of Endocrine Surgery, Department of Surgery, Duke University School of Medicine, DUMC #2945, Durham, NC 27710 (email@example.com).
Published Online: February 16, 2015. doi:10.1001/jamainternmed.2014.8020.
Author Contributions: Dr Sosa had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Goffredo, Dinan, Roman, Sosa.
Acquisition, analysis, or interpretation of data: Goffredo, Thomas, Dinan, Perkins.
Drafting of the manuscript: Goffredo, Dinan, Perkins, Roman.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Goffredo, Thomas, Dinan, Roman.
Obtained funding: Goffredo.
Administrative, technical, or material support: Dinan, Roman, Sosa.
Study supervision: Perkins, Roman, Sosa.
Conflict of Interest Disclosures: None reported.
Funding/Support: Dr Goffredo is supported by the Fondazione Italiana per la Ricerca sul Cancro (Italian Foundation for Cancer Research).
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: Some of the data used in the study are derived from a deidentified National Cancer Data Base file. The American College of Surgeons and the Commission on Cancer have not verified and are not responsible for the analytic or statistical methods used, or the conclusions drawn from these data by the investigators.
Additional Contributions: Mohamed Abdelgadir Adam, MD, Section of Endocrine Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, and Linda Youngwirth, MD, Duke Clinical Research Institute, and Section of Endocrine Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, assisted with data acquisition and statistical work. They were not compensated for their contributions.
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