Trends of Concomitant Diabetes and Peripheral Artery Disease and Lower Extremity Amputation in US Medicare Patients, 2007 to 2019.

BACKGROUND: Previous studies demonstrate geographic and racial/ethnic variation in diagnosis and complications of diabetes and peripheral artery disease (PAD). However, recent trends for patients diagnosed with both PAD and diabetes are lacking. We assessed the period prevalence of concurrent diabetes and PAD across the United States from 2007 to 2019 and regional and racial/ethnic variation in amputations among Medicare patients. METHODS: Using Medicare claims from 2007 to 2019, we identified patients with both diabetes and PAD. We calculated period prevalence of concomitant diabetes and PAD and incident cases of diabetes and PAD for every year. Patients were followed to identify amputations, and results were stratified by race/ethnicity and hospital referral region. RESULTS: 9 410 785 patients with diabetes and PAD were identified (mean age, 72.8 [SD, 10.94] years; 58.6% women, 74.7% White, 13.2% Black, 7.3% Hispanic, 2.8% Asian/API, and 0.6% Native American). Period prevalence of diabetes and PAD was 23 per 1000 beneficiaries. We observed a 33% relative decrease in annual new diagnoses throughout the study. All racial/ethnic groups experienced a similar decline in new diagnoses. Black and Hispanic patients had on average a 50% greater rate of disease compared with White patients. One- and 5-year amputation rates remained stable at ≈1.5% and 3%, respectively. Native American, Black, and Hispanic patients were at greater risk of amputation compared with White patients at 1- and 5-year time points (5-year rate ratio range, 1.22-3.17). Across US regions, we observed differential amputation rates, with an inverse relationship between the prevalence of concomitant diabetes and PAD and overall amputation rates. CONCLUSIONS: Significant regional and racial/ethnic variation exists in the incidence of concomitant diabetes and PAD among Medicare patients. Black patients in areas with the lowest rates of PAD and diabetes are at disproportionally higher risk for amputation. Furthermore, areas with higher prevalence of PAD and diabetes have the lowest rates of amputation.

The global burden of peripheral artery disease.

BACKGROUND: Previous efforts to characterize the burden of peripheral artery disease (PAD) have focused on national populations. A need for a more detailed analysis of how PAD impacts the global population has been identified. Our objective was to study in greater detail the global burden of PAD, including its impact on mortality, over the past three decades. METHODS: Using data and models from the Global Burden of Diseases, Injuries and Risk Factors Study, we estimated the prevalence, years of life lost, years lived with disability and disability-adjusted life-years (a measure accounting for incurred morbidity and mortality), attributable to PAD. We analyzed results over time and stratified by sex, age, and sociodemographic index (SDI) group. We compared PAD with other atherosclerosis-related conditions and assessed the contribution of risk factors to PAD disability-adjusted life-years. RESULTS: We observed a 72% increase in the global prevalence of PAD from an estimated 65,764,499 persons in 1990 to 113,443,016 in 2019. Prevalence per 100,000 persons increased 13% and the prevalence per 100,000 age-standardized decreased 22%. Similar patterns were seen for years of live lost, mortality, years lived with disability, and disability-adjusted life-years. The prevalence and disability were higher among women, whereas mortality and years of life lost were higher among men. Disease burden increased with increasing SDI. These increases in PAD were in contrast with global trends for the overall burden of ischemic heart disease and ischemic stroke, which had decreasing prevalence and disease-related mortality over the same time frame. Overall, only approximately 55% of PAD disease burden could be attributed to identified risk factors, with tobacco use, diabetes, and hypertension being the three major contributors in all SDI groups. CONCLUSIONS: The global prevalence and mortality associated with PAD has increased substantially, in contrast with other forms of ischemic cardiovascular disease. Globally, there is a growing need for vascular surgical resources to manage PAD, as well as public health efforts to address risk factors for this increasing health threat.

Deriving International Classification of Diseases, 9th and 10th revision, codes for identifying and following up patients with diabetic lower extremity ulcers.

Objective: Administrative claims data offer a rich data source for clinical research. However, its application to the study of diabetic lower extremity ulceration is lacking. Our objective was to create a widely applicable framework by which investigators might derive and refine the International Classification of Diseases, 9th and 10th revision (ICD-9 and ICD-10, respectively) codes for use in identifying diabetic, lower extremity ulceration. Methods: We created a seven-step process to derive and refine the ICD-9 and ICD-10 coding lists to identify diabetic lower extremity ulcers. This process begins by defining the research question and the initial identification of a list of ICD-9 and ICD-10 codes to define the exposures or outcomes of interest. These codes are then applied to claims data, and the rates of clinical events are examined for consistency with prior research and changes across the ICD-9 to ICD-10 transition. The ICD-9 and ICD-10 codes are then cross referenced with each other to further refine the lists. Results: Using this method, we started with 8 ICD-9 and 43 ICD-10 codes used to identify lower extremity ulcers in patients with known diabetes and peripheral arterial disease and examined the association of ulceration with lower extremity amputation. After refinement, we had 45 ICD-9 codes and 304 ICD-10 codes. We then grouped the codes into eight clinical exposure groups and examined the rates of amputation as a rudimentary test of validity. We found that the rate of lower extremity amputation correlated with the severity of lower extremity ulceration. Conclusions: We identified 45 ICD-9 and 304 ICD-10 ulcer codes, which identified patients at risk of amputation from diabetes and peripheral artery disease. Although further validation at the medical record level is required, these codes can be used for claims-based risk stratification for long-term outcomes assessment in the treatment of patients at risk of limb loss.

Comparison of Social Media Utilization Among Vascular Surgeons, Interventional Cardiologists, and Interventional Radiologists at Academic Training Institutions.

BACKGROUND: Social media platforms, especially Twitter, are increasingly utilized across medical practice, education, and research. However, little is known about differences in social media use among physicians of varying specialties and its impact on recruitment of trainees. Our objective was to describe differences in social media use among vascular interventional proceduralists at academic training institutions. METHODS: We identified institutions with training programs in vascular surgery (VS), interventional radiology (IR), and interventional cardiology (IC). Faculty providers were identified in each specialty at these institutions. A standardized search was used to identify non-anonymous social media profiles on Facebook, Instagram, and Twitter in September 2019. Influencers were defined as physicians with more than 1,000 Twitter followers. Follow ratio was defined as the number of followers divided by the number of accounts followed. Between-specialty differences were analyzed. RESULTS: A total of 1,330 providers (n = 454 VS, n=451 IR, n = 425 IC) were identified across 47 institutions in 27 states. Across all physicians, a minority of providers utilize social media (Facebook: 24.9%, n = 331; Instagram: 10.8%, n = 143; Twitter: 18.0%, n = 240). VS were significantly more likely to use Instagram (P = 0.001) but there was not a significant difference in utilization of Facebook and Twitter. Among Twitter users, VS had fewer followers on average (median 178, inter-quartile range [IQR] 39-555) than IR (median 272, IQR 50-793, P = 0.26) and IC (median 286, IQR 71-1257, P = 0.052). IC were most likely to be influencers (30.9%, n = 25) followed by IR (17.9%, n = 15) and VS (10.7%, n = 8, P = 0.006). On average, interventional cardiologists had the highest follow ratio (mean 4.9 ± 7.1) compared to interventional radiologists (mean 3.2 ± 5.5) and vascular surgeons (mean 2.5 ± 3.3, P < 0.001). CONCLUSION: A minority of academic vascular interventional proceduralists utilize social media in a non-anonymous manner. On Twitter, interventional cardiologists are most likely to be influencers based on number of followers and, on average, have the highest follow ratio. Vascular surgeons could potentially benefit from pursuing greater influence and visibility on social media as a means to recruit trainees.

Online Ratings for Vascular Interventional Proceduralists Vary by Physician Specialty.

BACKGROUND: Multiple specialties offer vascular interventional care, creating potential competition for referrals and procedures. At the same time, patient/consumer ratings have become more impactful for physicians who perform vascular procedures. We hypothesized that there are differences in online ratings based on specialty. METHODS: We used official program lists from the Association for Graduate Medical Education to identify institutions with training programs in integrated vascular surgery (VS), integrated interventional radiology (IR), and interventional cardiology (IC). Faculty providers were identified in each specialty at these institutions. A standardized search was performed to collect online ratings from Vitals.com, Healthgrades.com, and Google.com as well as from online demographics. Between specialty differences were analyzed using chi-squared and analysis of variance tests as appropriate. Multivariable linear regression was used to identify factors associated with review volume and star rating. RESULTS: A total of 1,330 providers (n = 454 VS, n = 451 IR, n = 425 IC) were identified across 47 institutions in 27 states. VS (55.5%-69.4%) and IC (63.8%-71.1%) providers were significantly more likely to have reviews than IR (28.6%-48.8%) providers across all online platforms (P < 0.001 for all websites). Across all platforms, IC providers were rated significantly higher than VS and IR providers. Multivariable regression showed that provider specialty and additional time in practice were associated with higher review volume. In addition to specialty, review volume was associated with star rating as those physicians with more reviews tended to have a higher rating. CONCLUSIONS: On average, vascular surgeons have more reviews and are more highly rated than interventional radiologists but tend to have fewer reviews and lower ratings than interventional cardiologists. VS providers may benefit from encouraging patients to file online reviews, especially in competitive markets.

Novel use of the ENROUTE transcarotid arterial sheath for antegrade cerebral perfusion during retrograde innominate stenting.

Femoral-carotid bypass has been described to preserve antegrade cerebral perfusion during aortic arch and great vessel interventions. We describe a novel use of the ENROUTE transcarotid arterial sheath (Silk Road Medical, Sunnyvale, Calif) as the outflow component of a femoral-carotid shunt for maintenance of antegrade cerebral perfusion during a retrograde innominate stenting procedure. We discuss the unique advantages of this sheath for use in this application.

A Comparison of Surgical Quality and Patient Satisfaction Indicators Between VA Hospitals and Hospitals Near VA Hospitals.

BACKGROUND: The Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act established a community care program allowing veterans to receive care outside Veteran Affairs Medical Centers (VAMCs). We sought to compare patient safety and satisfaction indicators from VAMCs and surrounding non-VAMCs (non-VAs). METHODS: We identified VAMCs with at least one non-VA acute care hospital within 25 miles in three geographic regions (West/Southwest, New England, and Deep South). Children's, specialty, and critical access hospitals were excluded. Using publicly available Hospital Compare data, we analyzed VAMC and surrounding non-VA performance in postsurgical patient safety indicator (PSI) events and Hospital Consumer Assessment of Healthcare Providers and Systems patient satisfaction scores and hospital star ratings. RESULTS: The 34 VAMCs performed better than 319 surrounding non-VAs in rates of wound dehiscence, accidental lacerations, and perioperative hemorrhage/hematoma as well as composite PSI rating (P < 0.05). VAMCs performed significantly better than non-VAs (18.0 versus 51.4 events per 1000 patients, P < 0.001) in composite surgery-specific PSIs. When comparing mean linear Hospital Consumer Assessment of Healthcare Providers and Systems score star ratings (1-5 scale), VAMCs had similar performance in overall hospital rating compared with non-VAs (3.28 versus 3.38, P = 0.48) and summary rating of hospital stays (2.87 versus 2.92, P = 0.69). When compiled patient satisfaction star ratings were compared, there was no difference (2.96 versus 2.97, P = 0.9). VAMCs performed worse than non-VAs in "would recommend" ratings (2.7 versus 3.13, P = 0.007). CONCLUSIONS: Across disparate regions, VAMCs match or outperform neighboring non-VAs in surgical quality metrics and patient satisfaction ratings. Veterans receiving surgical care at VAMCs may receive equivalent or better care than at non-VAs.

Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease.

Peripheral artery disease (PAD) stems from atherosclerosis of lower extremity arteries with resultant arterial narrowing or occlusion. The most severe form of PAD is termed chronic limb-threatening ischemia and carries a significant risk of limb loss and cardiovascular mortality. Diabetes mellitus is known to increase the incidence of PAD, accelerate disease progression, and increase disease severity. Patients with concomitant diabetes mellitus and PAD are at high risk for major complications, such as amputation. Despite a decrease in the overall number of amputations performed annually in the United States, amputation rates among those with both diabetes mellitus and PAD have remained stable or even increased in high-risk subgroups. Within this cohort, there is significant regional, racial/ethnic, and socioeconomic variation in amputation risk. Specifically, residents of rural areas, African-American and Native American patients, and those of low socioeconomic status carry the highest risk of amputation. The burden of amputation is severe, with 5-year mortality rates exceeding those of many malignancies. Furthermore, caring for patients with PAD and diabetes mellitus imposes a significant cost to the healthcare system-estimated to range from $84 billion to $380 billion annually. Efforts to improve the quality of care for those with PAD and diabetes mellitus must focus on the subgroups at high risk for amputation and the disparities they face in the receipt of both preventive and interventional cardiovascular care. Better understanding of these social, economic, and structural barriers will prove to be crucial for cardiovascular physicians striving to better care for patients facing this challenging combination of chronic diseases.

Long-Term Outcomes of Mesenteric Stenting and Analysis of In-Stent Restenosis Duplex Velocity Criteria.

BACKGROUND: Endovascular therapy for chronic mesenteric ischemia (CMI) is the mainstay of treatment. Duplex velocity criteria within stented mesenteric vessels are not well established. We describe single-center outcomes of mesenteric stenting for CMI and analyze duplex velocities associated with in-stent restenosis (ISR). METHODS: We performed a single-center retrospective review of patients undergoing mesenteric stenting for CMI (2012-2018). Primary outcome was reintervention for recurrence of CMI symptoms. Secondary outcomes were occlusion or bypass grafting. Duplex velocities in those with recurrent symptoms, corresponding with clinically significant ISR, were identified. Receiver operating characteristic (ROC) curves were created to identify velocity thresholds for ISR. RESULTS: Mesenteric stents were placed in 61 patients (71 arteries). Mean age was 72 years (range, 49-92), and the majority were female (55%). Thirty-two (45%) celiac (CA) stents and 39 (55%) superior mesenteric artery (SMA) stents were placed. Ten patients had SMA and CA stents placed. Twenty-five stents were covered (35%). Freedom from reintervention at 1, 2, and 3 years was 83%, 73%, and 60%. Freedom from occlusion or bypass grafting at 1, 2, and 3 years was 100%, 86%, and 86%. No significant difference in patency was seen between covered and bare-metal stents (OR 0.45; 95% CI: 0.15-1.33; P = 0.1383). Median survival was 6.1 years. For CA stents, a peak systolic velocity (PSV) of 440 cm/s corresponded with clinically significant ISR with 100% sensitivity and 86% specificity. For SMA stents, a PSV of 341 cm/s corresponded with clinically significant ISR with only 80% sensitivity and 52% specificity. CONCLUSIONS: A PSV of 440 cm/s for CA stents was indicative of clinically significant ISR with excellent sensitivity and specificity. This should be used in conjunction with clinical findings to identify patients that may benefit from repeat intervention. A similar threshold could not be identified for SMA stents and warrants further collaborative investigation.

A systematic review and meta-analysis of long-term reintervention after endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Patients who undergo endovascular aneurysm repair (EVAR) often require reintervention after the index repair. The long-term rate of reintervention and how this has changed with newer device technology are poorly understood. Therefore, we performed a systematic review and meta-analysis of the available literature to determine long-term freedom from reintervention after EVAR and the change in reintervention rates over time. METHODS: We performed a systematic review of MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included randomized controlled trials and observational studies that documented the rate of reintervention after EVAR. We performed a meta-analysis of Kaplan-Meier freedom from reintervention at each year after EVAR. We used linear regression to evaluate change in reintervention rate over time with newer device technology. RESULTS: We included a total of 30 studies (randomized trials, n = 3; observational studies, n = 27) comprising 32,126 patients in this review and meta-analysis. Studies ranged in the implantation date of the EVAR device from 1996 to 2014. The probability of freedom from reintervention was 81% (95% confidence interval [CI], 77%-85%) at 5 years, 70% (95% CI, 65%-76%) at 10 years, and 64% (95% CI, 46%-79%) at 14 years. Linear regression demonstrated an improvement in freedom from reintervention when results were stratified by the year of device implantation. At 1 year, estimated freedom from reintervention improved from 90% in 1998 to 94% in 2008 (n = 26 studies; R2 = 0.11; P = .10). At three years, estimated freedom from reintervention improved from 77% in 1998 to 90% in 2008 (n = 26 studies; R2 = 0.27; P = .006). At 5 years, estimated freedom from reintervention improved from 68% in 1998 to 81% in 2008 (n = 22 studies; R2 =0.12; P = .12). At 7 years, estimated freedom from reintervention improved from 51% in 1998 to 86% in 2011 (n = 22 studies; R2 = 0.40; P = .015). CONCLUSIONS: EVAR patients remain at risk for reintervention indefinitely, and therefore lifelong surveillance is imperative. Encouragingly, reintervention rates have improved over time, with newer devices exhibiting lower rates. Reintervention rate remains an important metric for new devices and registries.

Adverse cardiac events after vascular surgery are prevalent despite negative results of preoperative stress testing.

OBJECTIVE: Cardiac risk assessment is a critical component of vascular disease management before surgical intervention. The predictive risk reduction of a negative cardiac stress test result remains poorly defined. The objective of this study was to compare the incidence of postoperative cardiac events among patients with negative stress test results vs those who did not undergo testing. METHODS: We reviewed all patients who underwent elective open abdominal aortic aneurysm repair, suprainguinal bypass, endovascular aneurysm repair (EVAR), carotid endarterectomy (CEA), and infrainguinal bypass within the Vascular Study Group of New England from 2003 to 2017. We excluded patients with positive stress test results (n = 3312) and studied two mutually exclusive groups: elective surgery patients with a negative stress test result and elective surgery patients with no stress test (total n = 26,910). The primary outcome was a composite of in-hospital postoperative cardiac events (dysrhythmia, heart attack, heart failure) or death. RESULTS: A preoperative stress test was obtained in 66.3% of open repairs, 42.8% of suprainguinal bypasses, 37.1% of EVARs, 36.0% of CEAs, and 31.2% of infrainguinal bypasses. The proportion of patients receiving a preoperative stress test varied widely across centers, from 37.1% to 80.0%. The crude odds ratio of in-hospital postoperative cardiac event or death was 1.37 (95% confidence interval [CI], 1.07-1.76) for open repair and 1.52 (CI, 1.13-2.03) for suprainguinal bypass, indicating that patients with negative stress test results before these procedures were 37% and 52% more likely to suffer a postoperative event or die compared with patients selected to proceed directly to surgery without testing. Conversely, the crude odds ratio was 0.92 (CI, 0.66-1.29) for EVAR, 0.92 (CI, 0.70-1.21) for CEA, and 1.13 (CI, 0.90-1.40) for infrainguinal bypass, indicating that patients undergoing these procedures had a similar likelihood of sustaining an event whether they had a negative stress test result or proceeded directly to surgery without a stress test. CONCLUSIONS: The use of cardiac stress testing before vascular surgery varies widely throughout New England. Whereas patients are often appropriately selected to proceed directly to surgery, a negative preoperative stress test result should not assuage the concern for an adverse outcome as these patients retain a substantial likelihood of cardiac events, especially after large-magnitude procedures.

Characterizing Reimbursements for Medicare Patients Receiving Endovascular Abdominal Aortic Aneurysm Repair at Vascular Quality Initiative Centers.

BACKGROUND: Endovascular aortic aneurysm repair (EVR) has a major financial impact on health care systems. We characterized reimbursement for index EVR hospitalizations among Medicare beneficiaries having surgery at Vascular Quality Initiative (VQI) centers. METHODS: We linked Medicare claims to VQI clinical registry data for patients undergoing EVR from 2003 to 2015. Analysis was limited to patients fully covered by fee-for-service Medicare parts A and B in the year of their operation and assigned a corresponding diagnosis-related group for EVR. The primary outcome was Medicare's reimbursement for inpatient hospital and professional services, adjusted to 2015 dollars. We performed descriptive analysis of reimbursement over time and univariate analysis to evaluate patient demographics, clinical characteristics, procedural variables, and postoperative events associated with reimbursement. This informed a multilevel regression model used to identify factors independently associated with EVR reimbursement and quantify VQI center-level variation in reimbursement. RESULTS: We studied 9,403 Medicare patients who underwent EVR at VQI centers during the study period. Reimbursements declined from $37,450 ± $9,350 (mean ± standard deviation) in 2003 to $27,723 ± $10,613 in 2015 (test for trend, P < 0.001). For patients experiencing a complication (n = 773; 8.2%), mean reimbursement for EVR was $44,858 ± $23,825 versus $28,857 ± $9,258 for those without complications (P < 0.001). Intestinal ischemia, new dialysis requirement, and respiratory compromise each doubled Medicare's average reimbursement for EVR. After adjusting for diagnosis-related group, several patient-level factors were independently associated with higher Medicare reimbursement; these included ruptured abdominal aortic aneurysm (+$2,372), additional day in length of stay (+$1,275), and being unfit for open repair (+$501). Controlling for patient-level factors, 4-fold variation in average reimbursement was seen across VQI centers. CONCLUSIONS: Reimbursement for EVR declined between 2003 and 2015. We identified preoperative clinical factors independently associated with reimbursement and quantified the impact of different postoperative complications on reimbursement. More work is needed to better understand the substantial variation observed in reimbursement at the center level.

Coil embolization of an aberrant posterior tibial artery pseudoaneurysm after total knee arthroplasty.

Arterial injury is a recognized but rare complication of total knee arthroplasty. These injuries, however, can be exceptionally devastating and potentially result in limb loss. Presentation may be delayed with symptoms associated with mass effect rather than with ischemia. We describe treatment of a patient with presentation delayed 2 weeks. In addition, the patient's arterial branch pattern demonstrated aberrant anatomy with high takeoff of the posterior tibial artery. This patient was successfully treated with transcatheter coil embolization. The current treatment options and published literature are reviewed.

Patient Experience of Recovery After Major Leg Amputation for Arterial Disease.

OBJECTIVES: To date, studies of vascular amputees primarily examine quantitative outcomes following limb loss. Less is known about the patient's perspective after major lower limb amputation. Here, we define and describe the postamputation recovery period. METHODS: Qualitative study using purposive, maximum variation sampling on the variables of amputation level and times since surgery. We first conducted structured interviews with 20 participants (median age: 65 years, range: 45-88 years; 85% male; below knee amputation n = 14; above knee amputation n = 6; median time from amputation to interview = 16 months, range: 4-51 months). Findings were validated via a focus group with 5 amputees. Data were coded, analyzed, and interpreted by 2 reviewers. RESULTS: All participants expressed the desire to have an active role in the decision to undergo amputation, even while acknowledging that limb salvage options were exhausted. Following amputation, participants described a 6-month recovery period when they learned to modify daily activities to accommodate their new functional and psychological needs. Participants defined recovery as when they had regained functional independence, which was described as a level of mobility that allowed them to perform daily activities with minimal assistance. Concerns that participants felt were poorly addressed included uncontrolled pain, feeling unprepared to live with an amputation, and questions about prosthetics. Two of the 5 focus group participants stated a preference for amputation earlier in the treatment course. CONCLUSIONS: Postamputation recovery has an early (up to 6 months) and late phase (after 6 months) and concludes when amputees regain what they perceive as independence. Patients desire to participate in amputation decision-making; in this study, some would have preferred amputation earlier in their clinical course. Attention to the domains that impact quality of life, and fostering a shared decision-making process, are opportunities to enhance postamputation recovery.

Reading grade level and completeness of freely available materials on thyroid nodules: there is work to be done.

BACKGROUND: Patient education is one of the key components required for patients to participate in decision making for their care. Sources of information should be complete and understandable. The objective of this study was to assess the quality and reading grade level of freely available materials pertaining to the evaluation and treatment of thyroid nodules. METHODS: All available materials were gathered through a comprehensive Internet search or direct contact with each identified organization associated with thyroid care. Materials meeting inclusion criteria were assessed for completeness of content and reading grade level using the SMOG readability formula. Then, the DISCERN instrument was utilized to assess the quality of the five materials which had the best (lowest) and the five materials that had the worst (highest) SMOG reading grade levels. RESULTS: A total of 63 materials on thyroid nodule evaluation and management were identified. A minority of materials presented readers with a complete picture of the topic, describing both benefits and cautions of thyroid nodule evaluation, benefits and cautions of fine-needle thyroid nodule biopsy, or risks, benefits, and long-term effects of thyroidectomy. The SMOG reading grade level assessment was well above recommended levels. The range was eighth grade to college level; the mean and median reading grade level were 13. Lastly, the DISCERN instrument revealed that most of the materials with both the best and the worst reading grade levels assessed had "extensive or serious shortcomings" that would impede their usefulness as high-quality sources of information regarding management options. CONCLUSIONS: Existing thyroid nodule evaluation and management materials have serious shortcomings. Future work should focus on the development of patient materials that are both grade level appropriate and meet the DISCERN criteria for topic completeness and accuracy.