The American Journal of Surgery (2010) 199, 189 –198
Clinical Surgery-American
ATA practice guidelines for the treatment of differentiated thyroid cancer: were they followed in the United States? Olatokunbo M. Famakinwa, B.A.a, Sanziana A. Roman, M.D.a,*, Tracy S. Wang, M.D., M.P.H.b, Julie Ann Sosa, M.A., M.D.a a
Department of Surgery, Yale University School of Medicine, New Haven, CT, USA; and bDepartment of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA KEYWORDS: Differentiated thyroid cancer; American Thyroid Association guidelines; Thyroidectomy; Radioactive iodine; Lymphadenectomy
Abstract BACKGROUND: The aim of this study was to benchmark national practice patterns against American Thyroid Association guidelines for thyroidectomy, lymphadenectomy, and radioactive iodine (RAI) for differentiated thyroid cancer (DTC). METHODS: A cross-sectional analysis of patients with DTC in Surveillance, Epidemiology, and End Results was performed. Outcomes were practice accordance with guidelines for extent of surgery and RAI treatment. Predictors of accordance were identified. RESULTS: A total of 52,964 patients with DTC were included. Seventy-six percent were women, and 83% white. There was 71% accordance with surgery recommendations; among these, 15% underwent central lymphadenectomy, 31% had RAI but no lymphadenectomy, and 25% had RAI and lymphadenectomy. The highest accordance with guidelines was for patients aged ⬍45 years with stage II disease (80%); the lowest accordance was for patients aged ⱖ45 years with stage II disease (52%). Patients aged ⬎65 years and of black race had the lowest accordance (P ⬍ .001). CONCLUSIONS: Variation in practice suggests variation in the quality of care for DTC. Greater dissemination of evidence-based recommendations is needed for elderly and minority patients. © 2010 Elsevier Inc. All rights reserved.
Thyroid cancer has the fastest rising incidence of all major cancers, with an increase of 4% per year.1 In 2008, approximately 37,000 cases of thyroid cancer were diagnosed in the United States, most of which were differentiated thyroid cancer (DTC).2 The long-term prognosis for patients with DTC is excellent, with 10-year survival rates of ⬎90%.1 The optimal extent of surgery and rationale for use of adjuvant radioactive iodine (RAI) remnant ablation for patients with DTC has been controversial.3–9 * Corresponding author. Tel.: 203-785-2563; fax: 203-785-4067. E-mail address:
[email protected] Manuscript received March 2, 2009; revised manuscript April 29, 2009
0002-9610/$ - see front matter © 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2009.04.022
Given the advances in the diagnosis and therapy of thyroid nodules and thyroid cancer, the American Thyroid Association (ATA) appointed a task force in 2006 to reexamine treatment guidelines previously published in 1996. After an extensive literature review, a new set of management guidelines were published, including recommendations for the extent of thyroidectomy, lymphadenectomy and the indications for the use of postoperative RAI (recommendations 26, 27, and 32, respectively; Table 1).10 To encourage standardization of practice, several other professional societies also have published guidelines for the management of patients with DTC (Table 2).11–15
190 Table 1
The American Journal of Surgery, Vol 199, No 2, February 2010 Overview of the 2006 ATA guidelines for patients with DTC
Recommendation number 26
27
32
Recommendation level
Recommendation For most patients with thyroid cancer, the initial surgical procedure should be a near total or total thyroidectomy. Thyroid lobectomy alone may be sufficient treatment for small, low-risk, isolated, intrathyroidal papillary carcinomas in the absence of cervical nodal metastases. Routine central compartment (level VI) neck dissection should be considered for patients with papillary thyroid carcinoma and suspected Hürthle carcinoma. Near total or total thyroidectomy without central node dissection may be appropriate for follicular cancer, and when followed by RAI therapy, may provide an alternative approach for papillary and Hürthle cell cancers. RAI is recommended for patients with stages III and IV disease, all patients with stage II disease aged ⬍45 years, and most patients with stage II disease aged ⱖ45 years, and selected patients with stage I disease, especially those with multifocal disease, nodal metastases, extrathyroidal or vascular invasion, and/or more aggressive histologies.
A*
B†
B†
*Level A: strongly recommends. Evidence obtained from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes. †Level B: recommends. Evidence sufficient to determine effects on health outcomes, but strength limited by the number, quality, or consistency of the individual studies; generalizability to routine practice, or indirect nature of evidence on health outcomes.
Previous studies have demonstrated wide variability in guideline recommendations and the degree of compliance with guidelines by health care professionals in the treatment of thyroid disease.16 –19 The aim of this study was to use a national database to measure practice patterns in the United States in existence at the time the ATA guidelines were issued for thyroidectomy, lymphadenectomy, and RAI among patients with DTC. Understanding disparities between actual clinical practice and guidelines allows the identification of predictors of noncompliance and thereby efforts focused at improving education of patients and providers as well as guideline dissemination.
Methods DTC was defined as papillary thyroid cancer (PTC), follicular thyroid cancer (FTC), and Hürthle cell cancer (HCTC). Data on the incidence of DTC in the United States were obtained from the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute.20 This deidentified data set includes demographic information, pathologic characteristics (eg, American Joint Committee on Cancer [AJCC] stage, tumor site and morphology), as well as the treatment provided for each cancer diagnosis.21 The database uses the International Classification of Diseases for Oncology, third edition as the reference for histology coding (PTC: codes 8050, 8340 – 8344 and 8350; FTC: codes 8330 – 8332, 8335, and 8337; HCTC: code 8290).22 SEER collects data on oncology cases from 17 geographic regions (26% of the cancer population); these regions include Connecticut, Detroit, Hawaii, Iowa, New Mexico, San Francisco–Oakland, Utah, Seattle–Puget Sound, Atlanta, Kentucky, Los Angeles, San Jose–Monterey, greater
California, New Jersey, Louisiana, rural Georgia, and the Alaska Native Tumor Registry. The sixth edition of the AJCC staging manual divides the presence of regional lymph node metastasis (N1) into 2 groups, N1a and N1b, depending on the location of nodal metastases.21 Because of limitations in applying these same stratifications within the SEER data set, cancer stage was based on the fifth edition of the AJCC manual. All stage IV patients were grouped together. Demographic, clinical, and pathologic characteristics for all adult patients with DTC in SEER from 1973 to 2005 were identified. Given the limitations of the database, the time frames examined varied between each of the recommendations. Demographic information included age (18 – 44, 45– 64, 65–79, and ⱖ80 years), gender, race (white, black, Asian, and other), Hispanic origin, marital status, geographic location (Northeast, South, Midwest, and West), and year of diagnosis. Clinical features of the disease included the extent of thyroidectomy (total or near total, lobectomy, none), reason for no surgery (surgery not recommended, contraindicated or autopsy only, or refused), lymphadenectomy, RAI, and the number of other cancers. Pathologic characteristics included AJCC stage, tumor size, tumor extension, number of lymph nodes examined, number of positive nodes examined, and metastases. Aggressive histologies were defined as the insular and columnar variants.
ATA recommendations Recommendation 26 states that near total or total thyroidectomy should be performed for most patients with DTC. For patients with DTC and small, intrathyroidal tumors with no metastases, lobectomy is an appropriate
O. Famakinwa et al.
Table 2
Summary of published guidelines for patients with DTC Year
Near total/Total thyroidectomy
Central lymphadenectomy
RAI
American Association of Endocrine Surgeons/American Association of Clinical Endocrinologists11 Recommendation level European Thyroid Association12
2001
PTC: high-risk patients, bilateral nodules, extrathyroidal extension, local/distant metastases; FTC/HCTC: extensive capsular/vascular invasion None specified Tumor ⬎1 cm; evidence of metastases; history of radiation exposure
For enlarged nodes in central neck
Functioning thyroid remnant; metastases
None specified Preoperative/intraoperative evidence of node metastases None specified High-risk patients, even if nodes clinically uninvolved; palpable nodes at surgery
None specified Persistent disease; high risk for persistent, recurrent disease
IVC‡ PTC/HCTC: if nodes are palpable/biopsy proven; if negative nodes, consider prophylactic central neck dissection; FTC: positive nodes
IIIB† For patients with no gross disease in the neck, RAI may be considered based on pathology, intraoperative findings, and postoperative thyroglobulin levels
2A to 2B储
2A§
Recommendation level British Thyroid Association13
Recommendation level National Comprehensive Cancer Network (NCCN)*15
Recommendation level
2006
2007
2009
None specified PTC: tumor ⬎1 cm, multifocal disease, extrathyroidal spread, familial disease, clinically involved nodes, history of radiation exposure; FTC: evidence of vascular invasion, tumor ⬎4 cm; HCTC: all IIIB† to IVC‡ PTC: age (⬍15 or ⬎45 y), radiation history, distant metastases, bilateral nodularity, extrathyroidal extension, tumor ⬎4 cm, cervical node metastases, aggressive variant; FTC: vascular invasion, metastases, patient choice; HCTC: vascular invasion, patient choice 2A§
None specified Distant metastases; incomplete resection; complete resection, but high risk for recurrence or mortality (extrathyroidal extension, ⬎10 nodes, ⬎3 nodes with extracapsular spread)
Thyroid cancer treatment accordance with guidelines
Society
*The American Head and Neck Society encourages use of the NCCN guidelines (http://www.headandneckcancer.org/clinicalresources/guidelines.php).14 †Evidence obtained from well-designed nonexperimental descriptive studies, such as comparative studies, correlation studies, and case-control studies. ‡Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities. §The recommendation is based on lower level evidence (than randomized clinical trials), and there is uniform NCCN consensus. 储The recommendation is based on lower level evidence and there is nonuniform NCCN consensus (but no major disagreement).
191
192 method of treatment.10 For this recommendation, we incorporated patients from SEER 1988 to 2005 in our analysis. In recommendation 27, the ATA recommends that a central (level VI) compartment lymphadenectomy should be performed for patients with PTC or HCTC after near total or total thyroidectomy, unless postoperative RAI remnant ablation is performed.10 For patients with FTC, near total or total thyroidectomy without central compartment lymphadenectomy is acceptable; therefore, compliance with recommendation 27 was measured only for patients with PTC or HCTC. Adherence to recommendation 27 was defined in three ways: (1) patients receiving central compartment lymphadenectomy following surgery, but no RAI; (2) patients receiving RAI following surgery who did not undergo central compartment lymphadenectomy; and (3) patients receiving both central compartment lymphadenectomy and postoperative RAI. Central compartment lymphadenectomy included “regional lymph nodes removed, not otherwise specified (NOS)”, “neck dissection, NOS,” and “selective, limited, nodal sampling.” It excluded “modified,” “modified radical,” and “radical” neck dissections. Patients from SEER 1998 to 2002 were included in the analysis. According to recommendation 32, RAI is suggested for all patients with stages III and IV DTC, all patients with stage II DTC aged ⬍45 years, most patients with stage II DTC aged ⱖ45 years, and selected patients with stage I DTC (multifocal DTC, metastases, extrathyroidal or vascular invasion, or aggressive histologies).10 Patients from SEER 1998 to 2003 were included in this analysis. Logistic regression and 2 tests were performed to determine predictors of divergence between practice patterns and ATA recommendations 26, 27, and 32. Predictors on univariate analysis were incorporated into a multivariate linear regression model. Data analysis was performed using SPSS version 14.0 (SPSS, Inc., Chicago, IL). All tests were two-sided, with statistical significance set at a P value of ⱕ.05. SEER is a public database that contains no personal identifying information; therefore, this study was deemed exempt from institutional review board approval.
Results A total of 52,964 patients were diagnosed with DTC in SEER from 1973 to 2005 (Table 3).
The American Journal of Surgery, Vol 199, No 2, February 2010 underwent near total and 52% underwent total thyroidectomy. Twenty-four percent of patients were not managed in accord with this guideline; 21% underwent lobectomy, and 3% did not receive surgery. Practice in accordance with guidelines decreased with increasing patient age; while 78% of patients aged 18 to 44 years received near total or total thyroidectomy, only 70% of patients aged 65 to 79 years and 57% of patients aged ⱖ80 years received the same surgery (P ⬍ .001; Table 5). Racial and geographic differences were evident; 76% of white patients with DTC received the recommended intervention, compared with 70% of black patients (P ⬍ .001). Geographically, the West had the greatest conformity with guidelines (79%), while the Northeast had the lowest (68%; P ⬍ .001). On multivariate analysis, predictors of nonconformity with surgical treatment included age ⱖ80 years, patients receiving care in the Northeast or South, intrathyroidal tumors, the diagnosis of FTC, and lack of metastasis (Table 6).
Recommendation 27: lymphadenectomy Overall, 10,347 patients were identified; 71% had care in accordance with recommendation 27 (Table 4). Of these patients, 25% received both RAI and central compartment lymphadenectomy, 15% underwent lymphadenectomy alone, and 31% received only RAI. Accordance with guidelines was lower among elderly patients; 76% of patients aged 18 to 44 years underwent RAI as recommended, compared with 58% of patients aged ⱖ80 years (Table 5). Care of black patients was in accordance 55% of the time, compared with 72% of the care of white patients (P ⬍ .001). Care of patients with stage IV DTC was most often in line with ATA recommendations (89%); care of stage I patients was the least in line (71%; P ⬍ .001). Fourteen percent of patients with extrathyroidal tumor extension did not receive the recommended intervention. Patients with regional and distant metastases received care that was ⱖ94% in agreement with lymphadenectomy guidelines, compared with patients with no metastases (67%; P ⬍ .001). In multivariate analysis, the only predictors of nonconformity with guidelines were patients receiving care in the South and lack of metastatic disease (Table 6).
Recommendation 32: use of RAI remnant ablation Recommendation 26: surgical treatment To measure practice patterns benchmarked against this recommendation, 31,846 cases were examined (Table 4). Patients with PTC tumor sizes ⬍1 cm, intrathyroidal extension, and no metastases were excluded. All remaining patients (n ⫽ 26,157) met ⱖ1 of the following criteria: (1) PTC tumor size ⱖ1 cm, (2) all FTC and HCTC tumor sizes, (3) extrathyroidal extension, and (4) presence of regional (lymph node) metastases. Of the remaining patients, 24%
For this recommendation, 10,998 patients were included in the analysis; overall accordance was 62% (Table 4). Sixty-one percent of patients with stage III DTC and 64% of patients with stage IV DTC received RAI (Table 4). Eighty percent of patients with stage II DTC aged ⬍45 years received RAI, while 52% of patients with stage II DTC aged ⱖ45 years received RAI. For stage I patients with extrathyroidal extension, nodal metastases, or aggressive histologies, care was in accordance with the guidelines 68% of the
O. Famakinwa et al.
Thyroid cancer treatment accordance with guidelines Table 3
Table 3 Demographic, clinical, and pathologic characteristics of patients with DTC in SEER, 1973 to 2005 (n ⫽ 52,964) Patient characteristic Demographic Age (y) (n ⫽ 52,964) 18–44 45–64 65–79 ⱖ80 Gender (n ⫽ 51,071) Female Race (n ⫽ 52,588) White Black Asian/Pacific Islander/other Hispanic origin (n ⫽ 52,964) Non-Hispanic Marital status (n ⫽ 51,071) Married Geography (n ⫽ 52,964) Northeast Midwest South West Year of diagnosis (n ⫽ 52,964) 1973–1987 1988–1997 1998–2005 Clinical Number of other cancers (n ⫽ 52,964) 1 ⱖ2 Surgery at primary site (n ⫽ 41,980) None Lobectomy/isthmusectomy Near total/total thyroidectomy Reason for no surgery (n ⫽ 2333) Surgery not recommended Contraindicated; autopsy only Patient or guardian refused Unknown Lymphadenectomy (n ⫽ 17,020) No regional lymph nodes removed Regional lymph nodes removed, NOS Neck dissection, NOS Selective, limited, “berry picking” Modified radical/radical Radiation therapy (n ⫽ 50,085) None Radioisotopes Other forms of radiation Pathologic AJCC stage (n ⫽ 27,854) I II III IV Tumor size (cm) (n ⫽ 35,570) ⬍1 1–1.9 2–3.9 ⱖ4 Unknown
193 (continued)
Patient characteristic %
46 37 14 3 76 83 6 11 89 65 17 16 11 56 17 28 55 12 2
Tumor extension (n ⫽ 34,442) Intrathyroidal Number of nodes examined (n ⫽ 43,656) 0 1 2–4 ⱖ5 Unknown Number of positive nodes (n ⫽ 16,181) 0 1 2–4 ⱖ5 Unknown Lymph node metastases (n ⫽ 29,047) None Ipsilateral cervical Bilateral/contralateral cervical Mediastinal Regional, NOS Distant Histology (n ⫽ 52,964) Papillary Follicular Hürthle cell (oxyphilic)
% 83
63 12 11 10 4
51 17 14 11 7 77 10 2 2 8 1 83 13 4
64 23 3 6 4
time. Forty percent of patients aged ⱖ80 years received treatment, compared with 57% to 68% of younger patients (P ⬍ .001). Patients treated in the West received RAI almost twice as often as those in the Northeast (68% vs 36%; P ⫽ .001). RAI administration among patients with stage II DTC was the least in accord with guidelines (47%) compared with all other stages. On multivariate analysis, demographic predictors for gaps between recommendations and practice were age ⱖ80 years and treatment in the Northeast, South, or Midwest. Clinical predictors of divergence from guidelines included presence of an intrathyroidal tumor, increasing number of other cancers, and lack of metastases (Table 6).
59 36 5
Comments
5 24 71 20 37 4 39
72 9 14 5 23 22 29 13 13
To our knowledge, this is the first study to examine clinical practice patterns among health care professionals benchmarked against ATA guidelines for the management of DTC. Overall, practice patterns were closest to the established guidelines for patients who were 18 to 44 years old and white, who had small tumors. Our findings confirm previous studies demonstrating variation in adherence to treatment guidelines by health care practitioners. Technological advances in medicine and studies demonstrating variation in care have driven the development of treatment guidelines and practice standards for the evalua-
194
The American Journal of Surgery, Vol 199, No 2, February 2010
Table 4
Accordance with ATA recommendations 26, 27, and 32
Characteristic
%
Recommendation 26: most patients with DTC should receive a near total/total thyroidectomy (n ⫽ 26,157) Near total/total thyroidectomy* Lobectomy No surgery Recommendation 27: patients with PTC and HCTC who receive near total/total thyroidectomy may not need a central compartment lymphadenectomy if receiving RAI; patients with PTC and HCTC who receive near total thyroidectomy may not need RAI if receiving a central compartment lymphadenectomy (n ⫽ 10,347) Lymphadenectomy, no RAI* RAI, no lymphadenectomy* RAI and lymphadenectomy* No lymphadenectomy, no RAI Recommendation 27, part 1: routine central compartment (level VI) neck dissection should be considered for patients with PTC (n ⫽ 10,543) Lymphadenectomy* No lymphadenectomy Recommendation 27, part 2: routine central compartment (level VI) neck dissection should be considered for patients with HCTC (n ⫽ 529) Lymphadenectomy* No lymphadenectomy Recommendation 27, part 3: patients with FTC should receive near total/total thyroidectomy (n ⫽ 1560) Near total/total thyroidectomy* Lobectomy No surgery Recommendation 27, part 4: RAI therapy following near total/total thyroidectomy may be an alternative approach for patients with PTC (n ⫽ 10,359) RAI* No RAI Recommendation 27, part 5: RAI therapy following near total/total thyroidectomy may be an alternative approach for patients with HCTC (n ⫽ 491) RAI* No RAI Recommendation 32: RAI for selected stage I (extrathyroidal extension or nodal metastases or aggressive histologies), stages II–IV (n ⫽ 10,998) RAI* No RAI Recommendation 32, part 1: RAI is recommended for patients with stage III disease (n ⫽ 3607) RAI* No RAI Recommendation 32, part 2: RAI is recommended for patients with stage IV disease (n ⫽ 1029) RAI* No RAI Recommendation 32, part 3: RAI is recommended for patients with stage II disease aged ⬍45 y (n ⫽ 40) RAI* No RAI Recommendation 32, part 4: RAI is recommended for most patients with stage II disease aged ⱖ45 y (n ⫽ 2268) RAI* No RAI Recommendation 32, part 5: RAI for selected patients with stage I disease and extrathyroidal extension or nodal metastases or aggressive histologies (n ⫽ 4054) RAI* No RAI
76 21 3
15 31 25 29
41 59
25 75 67 26 7
56 44
57 43
62 38 61 39 64 36 80 20 52 48
68 32
*Accordance with ATA guidelines
tion and management of many diseases.15 Even with practice guidelines, physician awareness and compliance remain inconsistent. For example, in a study of the effect of practice guidelines on 2 hospitals within the same medical community, Studnicki et al23 found significant differences in the treatment of women with breast cancer. These findings support the premise of Jack Wennberg, who postulated that
variation in practice among health care providers translates into variation in the costs and quality of care.24 The impact of treatment guidelines on the management of breast cancer has been examined. Using SEER, Lazovich et al25 evaluated the use of breast conservation therapy before and after a 1990 National Institutes of Health (NIH) Consensus Development Conference recommending breast
O. Famakinwa et al. Table 5
Thyroid cancer treatment accordance with guidelines
195
Compliance with ATA recommendations 26, 27, and 32 by patient characteristics
Patient characteristic Demographic Age (y) 18–44 45–64 65–79 ⱖ80 Gender Male Female Race White Black Asian/Pacific Islander Other Hispanic origin Non-Hispanic Hispanic Marital status Married Not married Year of diagnosis 1988 – 1997 1998 – 2005 Geography Northeast Midwest South West Clinical Number of other cancers 1 ⱖ2 Pathologic AJCC stage I II III IV Tumor size (cm) ⬍1 1–1.9 2–3.9 ⱖ4 Unknown Tumor extension Intrathyroidal Extrathyroidal Number of nodes examined 0 1 2–4 ⱖ5 Unknown Number of positive nodes 0 1 2–4
Recommendation 32 (RAI treatment) (n ⫽ 10,998)
Recommendation 27 (Lymphadenectomy) (n ⫽ 10,347)
Recommendation 26 (Surgical treatment) (n ⫽ 26,157) Compliance (%)
P
Compliance (%)
P
Compliance (%)
P
78 77 70 57
⬍.001
76 69 65 58
⬍.001
68 61 57 40
⬍.001
75 76
⬍.05
74 71
⬍.01
61 63
NS
76 70 75 77
⬍.001
72 55 73 77
⬍.001
62 52 65 68
⬍.001
75 79
⬍.001
71 74
⬍.01
62 65
⬍.05
77 75
⬍.001
72 71
NS
63 60
⬍.001
67 81
⬍.001
62 62
NS
68 75 73 79
⬍.001
58 65 69 77
⬍.001
36 61 62 68
⬍.001
72 65
⬍.001
68 69
NS
56 54
⬍.001
79 75 81 76
⬍.001
71 73 87 89
⬍.001
68 53 61 64
⬍.001
80 78 78 73 62
⬍.001
54 77 80 76 66
⬍.001
62 68 63 58 54
⬍.001
75 81
⬍.001
68 86
⬍.001
60 68
⬍.001
70 82 86 91 75
⬍.001
52 98 99 99 86
⬍.001
54 60 68 70 67
⬍.001
83 85 89
⬍.001
97 99 99
⬍.001
60 64 70
⬍.001 (Continued on next page)
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The American Journal of Surgery, Vol 199, No 2, February 2010
Table 5
(continued)
Compliance (%)
Patient characteristic ⱖ5 Unknown Lymph node metastases None Ipsilateral cervical Bilateral/contralateral cervical Mediastinal Regional, NOS Distant Histology Papillary Hürthle cell Follicular
Recommendation 32 (RAI treatment) (n ⫽ 10,998)
Recommendation 27 (Lymphadenectomy) (n ⫽ 10,347)
Recommendation 26 (Surgical treatment) (n ⫽ 26,157) P
Compliance (%)
93 71
P
Compliance (%)
99 87
P
74 67
76 88 91 85 84 74
⬍.001
67 99 99 98 99 94
⬍.001
56 70 76 73 61 68
⬍.001
79 71 64
⬍.001
72 67 *
⬍.05
64 51 51
⬍.001
*FTC was not included in this analysis.
conservation therapy for most women with stage I and II breast cancer. The authors found that use of breast conservation surgery increased from 35% of women with stage I and 19% of women with stage II disease in the period before the conference (1985–1989) to 60% and 39%, respectively, in 1995.25 However, regional variation was noted, and no registry reported breast conservation therapy for most women with stage II disease, suggesting that there was not widespread adoption of the recommendations. These results were corroborated in a study of American College of Surgeons cancer registries.26 Of 22 standards evaluated, breast conservation treatment adherence was ⱖ80% for 16 standards (73%); compliance was found to vary by type of hospital cancer program, geographic region, and patient age, race, and payer type.26 Disparities in the care of patients with endocrine disorders on the basis of patient race, age, or providers’ lack of Table 6
awareness of clinical practice guidelines previously have been shown. Using data from the Healthcare Cost and Utilization Project National Inpatient Sample, Sosa et al27,28 studied length of stay, costs, complication, and mortality rates in patients undergoing thyroidectomy, stratified by race or ethnicity and age. In independent studies, black patients and patients aged ⬎80 years were found to have significantly longer lengths of stay, and higher costs, complications and mortality rates. In 2003, Mahadevia et al29 surveyed practicing endocrinologists with regard to their knowledge of, and compliance with, the 1990 NIH recommendations for parathyroidectomy in patients with asymptomatic primary hyperparathyroidism (pHPT). Up to 25% of high-volume (ⱖ12 cases/y) and 50% of low-volume (⬍12 cases/y) endocrinologists were not aware of the NIH guidelines. Furthermore, there was significant variation in the management of these pa-
Multivariate analysis of predictors of practice divergence from ATA recommendations 26, 27, and 32 Recommendation 26 (Surgical treatment)
Recommendation 27 (Lymphadenectomy)
Characteristic
OR
95% CI
P
Age ⱖ80 y Non-Hispanic origin Northeast Midwest South Increased number of other cancers Intrathyroidal tumor Increased number of nodes examined No metastasis Follicular histology
2.62
1.41–4.86
⬍.01
2.51
1.96–3.21
⬍.001
1.89
1.37–2.60
1.45 .97 1.69 2.35
OR
P
OR
95% CI
P
⬍.001
⬍.001
2.81 .71 5.48 2.43 1.59
1.69–4.68 .56–.89 4.36–6.87 1.83–3.23 1.19–2.13
⬍.001 ⬍.01 ⬍.001 ⬍.001 ⬍.01
1.08–1.94
⬍.05
1.35 1.24
1.10–1.65 1.04–1.48
⬍.01 ⬍.05
.95–.99 1.32–2.16 1.69–3.27
⬍.01 ⬍.001 ⬍.001
1.4
1.16–1.69
3.77
.14 3.36
95% CI
Recommendation 32 (RAI treatment)
2.28–6.23
.09–.21 1.62–6.95
CI ⫽ confidence interval; OR ⫽ odds ratio (OR ⬍1 indicates better accordance).
⬍.001 .001
.001
O. Famakinwa et al.
Thyroid cancer treatment accordance with guidelines
tients; 7% of physicians referred ⱖ90% of asymptomatic patients for surgical treatment, while 31% of physicians referred ⱕ10% of patients. Adherence to monitoring guidelines for nonsurgically managed patients was also highly variable.29 Differences in the surgical management of pHPT also exist; in a survey of members of the American Association of Endocrine Surgeons, Sosa et al30 found that criteria for surgery varied widely among surgeons and appeared to be associated with surgeon experience. In particular, high-volume surgeons (⬎50 cases/y) had a lower threshold for surgery than their low-volume colleagues. In a separate survey of the American Association of Endocrine Surgeons by Kouvouraki et al,31 89% of endocrine surgeons were aware of the NIH guidelines for surgery for pHPT; 85% of respondents would operate on a patient who did not meet NIH criteria but who had other nonspecific symptoms. High-volume surgeons (⬎30 cases/y) more often operated on all patients with pHPT, regardless of objective parameters.31 Multiple studies have examined differences in the management of thyroid disease; surveys of North American and European endocrinologists on the optimal approach to patients with solitary thyroid nodules and nontoxic multinodular goiters have underscored variations in practice patterns.32–35 A study of Australian endocrinologists and endocrine surgeons further highlighted differences in the management of thyroid nodules; there were significant differences between Australian endocrinologists and surgeons in their treatment recommendations in 12 of 13 clinical scenarios.36 In a study conducted by the American College of Surgeons Commission on Cancer, 1500 hospitals were surveyed regarding treatment of thyroid cancer.18 Three areas for improvement were identified: (1) more frequent use of diagnostic fine-needle aspiration cytology, (2) more use of preoperative laryngoscopy, and (3) standardized lymph node resection and analysis to improve staging of DTC.18 There is a paucity of evidence with regard to compliance with published guidelines in the treatment of thyroid disease. Van den Bruel et al19 surveyed members of the Belgian Thyroid Club regarding management of an index case of a thyroid nodule. With respect to the extent of surgery for DTC (ATA recommendation 26), 96% of respondents favored total thyroidectomy, 26% no lymphadenectomy, 27% central compartment lymphadenectomy, and 36% both central and lateral compartment lymphadenectomy (ATA recommendation 27). There was also significant variation with regard to use of RAI (ATA recommendation 32) and longterm surveillance.19 Central compartment lymphadenectomy is a controversial issue within endocrinology and endocrine surgery.7–9,37 To date, there has not been an adequately powered, prospective study measuring the benefit of routine central compartment lymphadenectomy; some studies have shown that central compartment lymphadenectomy comes with in-
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creased morbidity with respect to hypoparathyroidism and recurrent laryngeal nerve injury.7,38 In addition, there is a lack of consensus as to the definition of a central compartment lymphadenectomy, with respect to laterality, the number of lymph nodes resected, and/or the anatomic extent of resection. Our results suggest that many surgeons in the United States do not perform routine central compartment lymphadenectomy, as compliance with recommendation 27 is primarily achieved through RAI administration. The administration of RAI among practitioners and institutions is also highly variable, with respect to method of thyroid hormone withdrawal, use of recombinant thyroid stimulating hormone, and the optimal dosage of 131I for remnant ablation.3,5 There are several limitations to this study, including those inherent to the use of any administrative database, such as errors in coding and sampling. These included changes in coding for thyroid cancer stage and extent of lymphadenectomy over time. SEER registries have extensive data quality profiles, validated since 1973, which help ensure overall accuracy.39 With the exception of other cancers, there are no data in SEER regarding patient comorbidities. Therefore, we used this measure as a proxy for complexity of illness. The lack of consensus regarding the definition of “lymphadenectomy” among practitioners implies that the coding for this variable in SEER is more likely to be inconsistent. Although this is an acknowledged limitation, it is also the state of the science and continues to be an ongoing discussion, even among experienced endocrine surgeons. Finally, this study examines practice patterns at the time the ATA guidelines were released, because SEER data are not yet available for subsequent years. This is the first study to examine practice patterns at a national level among health care professionals benchmarked against ATA guidelines for the management of DTC. The purpose of this study was to examine ongoing practice patterns at the time of publication of ATA guidelines; according to our analysis, 24% to 32% of patients with DTC were receiving care that was inconsistent with ATA guidelines. A prospective study is needed to measure whether practice patterns have changed since publication. It is important to maintain the currency of guidelines, such that they reflect advances in scientific and technologic evidence. In addition, a collaborative effort is required among health care professionals, patients, and policy makers to disseminate evidence-based guidelines and minimize apparent disparities in the quality of care provided to patients with DTC.
Acknowledgment We would like to acknowledge Henry S. Park, B.S., who helped with database management and data analysis.
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