Reprocessing Standards for Medical Devices and Equipment in Otolaryngology: Safe Practices for Scopes, Speculums, and Single-Use Devices.

Stringent regulatory standards for reprocessing medical devices and equipment have proliferated in response to patient safety incidents in which improperly disinfected or contaminated endoscopes lead to large-scale disease transmission or outbreaks. This article details best practices in reprocessing reusable and single-use devices in otolaryngology, with particular attention to flexible fiberoptic endoscopes/nasophyarngoscopes, nasal speculums, and other clinic and operating room instruments. High-risk devices require sterilization, whereas lower risk devices may be reprocessed using various disinfection procedures. Reprocessing practices have implications for adequacy, efficiency, and cost. Nuanced understanding of procedures and their rationale ensures delivery of safe, ethical, and quality patient care.

Diagnostic Delays and Errors in Head and Neck Cancer Patients: Opportunities for Improvement.

A retrospective review of 100 sequential patients (2009-2012) with head and neck cancer was performed to determine the frequency of 5 types of diagnostic delays and errors outlined by the Institute of Medicine. There were a total of 105 diagnostic delays/errors. The most common was delay in being seen in the otolaryngology clinic after referral placement (28.6%), followed by diagnostic error by the referring physician (22%), delay in referral of a symptomatic patient to the otolaryngology clinic (16.2%), delay in employing an appropriate diagnostic test or procedure (15.2%), delay in action following reporting of pathology or imaging results for an incidental lesion (11.4%), diagnostic error by the otolaryngology clinic (2.8%), delay in action following reporting of pathology or imaging results for the symptomatic lesion (2.8%), and use of outmoded tests or therapy (1%). Increased awareness of these types of delays/errors will direct actions and processes to reduce or eliminate them.

Lean Belt Certification: Pathway for Student, Resident, and Faculty Development and Scholarship.

Since July 2013, 20 trainee participants have completed the quality improvement curriculum within the Indiana University Department of Otolaryngology-Head & Neck Surgery, including 7 otolaryngology residents, 6 otolaryngology-bound medical students, and 7 psychiatry residents. Nine faculty and staff attended. Participants were highly satisfied with the quality and effectiveness of the program. Following program implementation, 2 otolaryngology residents and 2 medical students initiated their own quality improvement projects. Lean training directly resulted in oral and poster presentations at national conferences, journal publications, and institutional research and quality awards. Students completing the program established a local affiliate group of an international health care quality organization. Quality improvement training can be successfully incorporated into residency training with overwhelming program satisfaction and results in greater scholarly and professional development for motivated participants. The skillset acquired by participants leads to projects that improve patient care, increase value, and justify equipment and personnel retention and expansion.

Impact of Lean on surgical instrument reduction: Less is more.

OBJECTIVES/HYPOTHESIS: To determine whether instrument sets that are frequently used by multiple surgeons can be substantially reduced in size with consensus. STUDY DESIGN: Prospective quality improvement study using Lean Six Sigma for purposeful and consensual reduction of non-value-added instruments in adenotonsillectomy instrument sets. METHODS: Value stream mapping was utilized to determine instrumentation usage and reprocessing workflow. Preintervention instrument utilization surveys allowed consensual and intelligent set reduction. Non-value-added instruments were targeted for waste elimination by placement in a supplemental set. Times for pre- and postintervention instrument assembly, Mayo setup, and surgery were collected for adenotonsillectomies. Postintervention satisfaction surveys of surgeons and staff were conducted. RESULTS: Adenotonsillectomy sets were reduced from 52 to 24 instruments. Median assembly times were significantly reduced from 8.4 to 4.7 minutes (P < .0001) with a set assembly cost reduction of 44%. Following natural log transformations, mean Mayo setup times were significantly reduced from 97.6 to 76.1 seconds (P < .0001), and mean operative times were not significantly affected (1,773 vs. 1,631 seconds, P > .05). The supplemental set was opened in only 3.6% of cases. Satisfaction was >90% regarding the intervention. Set build cost was reduced by $1,468.99 per set. CONCLUSIONS: Lean Six Sigma improves efficiency and reduces waste by empowering team members to improve their environment. Instrument set reduction is ideal for waste elimination because of tool accumulation over time and instrument obsolescence as newer technologies are adopted. Similar interventions could easily be applied to larger sinus, mastoidectomy, and spine sets. LEVEL OF EVIDENCE: NA.

Rapid mandible margins for intraoperative assessment.

OBJECTIVES: To determine the feasibility of a rapid method of processing mandible bone margins for intraoperative histopathologic examination and to assess the relative value of fine, coarse, and core specimens in assessing bone margins. STUDY DESIGN: Prospective histologic controlled study. SETTING: A tertiary level academic medical center histopathology laboratory. SUBJECTS AND METHODS: Multiple bone samples were collected from fresh (<12 hours post-mortem) human cadaveric mandible using a 1) standard 4mm otolaryngologic cutting drill bit 2) diamond drill bit and 3) cutting core biopsy trocar. The specimens were placed in one of three decalcifying solutions (Decal A, Calex, EDTA Decal) from 15 to 75 minutes or control (fixation in 10% formalin). After each designated decalcification time period, specimens were cryosectioned or paraffin embedded and subsequently reviewed by a head and neck surgical pathologist. The specimens were assessed for overall quality, adequacy of decalcification, soft tissue quality, marrow quality, and presence of artifact. RESULTS: Bone margin specimens collected with a 4mm burr and processed with EDTA Decal for 30 minutes yielded the highest quality histopathologic slides compared to the other methods in a similar time frame. The adequacy of decalcification directly impacted the quality of histopathologic assessment. CONCLUSIONS: Mandible bone margins can be rapidly and safely prepared and adequately evaluated with only 30 minutes of decalcification. This method may provide acceptable intraoperative assessment of bone margins in patients with tumors which involve or approximate bone. We plan to examine this model in a prospective clinical study of patients with cancer invading mandibular bone.

Lean Six Sigma Applied to Ultrasound Guided Needle Biopsy in the Head and Neck.

OBJECTIVES: (1) Confirm the positive value stream of office-based ultrasound using Lean Six Sigma; (2) demonstrate how ultrasound reduces time to diagnosis, costs, patient inconvenience and travel, exposure to ionizing radiation, intravenous contrast, and laboratory tests. STUDY DESIGN: Case series with historical controls using chart review. SETTING: Tertiary Veterans Administration Hospital (university-affiliated). SUBJECTS AND METHODS: Patients with a consult request or decision for ultrasound guided fine needle aspiration (USFNA) from 2006 to 2012. Process evaluation using Lean Six Sigma methodologies; years study conducted: 2006-2012; outcome measurements: type of diagnostic tests and imaging studies including CT scans with associated radiation exposure, time to preliminary and final cytopathologic diagnosis, episodes of patient travel. RESULTS: Value stream mapping prior to and after implementing office-based ultrasound confirmed the time from consult request or decision for USFNA to completion of the USFNA was reduced from a range of 0 to 286 days requiring a maximum 17 steps to a range of 0 to 48 days, necessitating only a maximum of 9 steps. Office-based USFNA for evaluation of head and neck lesions reduced costs, time to diagnosis, risks and inconvenience to patients, radiation exposure, unnecessary laboratory, and patient complaints while increasing staff satisfaction. In addition, office-based ultrasound also changed the clinical management of specific patients. CONCLUSION: Lean Six Sigma reduces waste and optimizes quality and accuracy in manufacturing. This is the first known application of Lean Six Sigma to office-based USFNA in the evaluation of head and neck lesions. The literature supports the value of office-based ultrasound to patients and health care systems.

The effects of alar batten grafts on nasal airway obstruction and nasal steroid use in patients with nasal valve collapse and nasal allergic symptoms: a prospective study.

IMPORTANCE: Clinical management of nasal airway obstruction (NAO) in patients with and without nasal allergic symptoms and nasal valve collapse (NVC). OBJECTIVE: To examine the impact that autologous alar batten grafts have on patients with NAO owing to NVC and their affect on nasal steroid use and allergic symptoms. DESIGN: A prospective study. SETTING: Indiana University Medical Center, Indianapolis. PARTICIPANTS: Patients with NAO due to NVC with or without symptoms of nasal allergic symptoms. INTERVENTIONS: All of the patients had placement of autologous batten grafts during the study period. STUDY SELECTION: Prospective study of patients with dynamic NVC undergoing alar batten graft treatment. DATA EXTRACTION: Nasal Obstruction Symptom Evaluation survey preoperatively and postoperatively, prospective outpatient questionnaire to determine use of nasal steroids and presence of nasal allergic symptoms preoperatively and postoperatively. RESULTS: A total of 126 patients underwent surgical intervention for the treatment of NAO due to NVC. All of these patients were using nasal steroid sprays, and 78 patients (62%) also reported nasal allergic symptoms at their initial presentation. At 6-month and 1-year postoperative evaluations, 118 (94%) and 122 (97%), respectively, reported significant improvement of their NAO, regardless if they had presented with or without allergic nasal symptoms. Sixty-two of the 78 patients (79%) who initially presented with NAO owing to NVC and nasal allergic symptoms preoperatively reported significant improvement in their NAO and nasal allergic symptoms postoperatively. Eight of 126 (6%) restarted their use of nasal steroids postoperatively. All 8 of these patients reported nasal allergic symptoms preoperatively. No patients in the nonallergic group continued the use of nasal steroids postoperatively. There was no increase in nasal steroid use at the 12-month follow-up visit. CONCLUSIONS AND RELEVANCE: Nasal airway obstruction due to NVC in patients can be surgically treated with autologous alar batten grafts. In addition, the use of alar batten grafts may improve NAO in patients with nasal allergic symptoms and reduces their use of nasal steroids. These results support the idea of potential surgical repair of the nasal valve to treat patients with NAO due to nasal allergic symptoms and NVC. LEVEL OF EVIDENCE: 4.

The effect of cartilaginous reinforcing sutures on initial tracheal anastomotic strength: a cadaver study.

OBJECTIVE: During tracheal resection with primary anastomosis, cartilaginous reinforcing sutures may be placed outside of the primary anastomosis with the goal of preventing early dehiscence. The direct effect of such reinforcing sutures on anastomotic strength has not been previously investigated. The goal of this study was to determine if the addition of cartilaginous reinforcing sutures adds to tracheal anastomosis stability. STUDY DESIGN: Prospective cadaver study. SETTING: This research was conducted at an anatomy lab at Indiana University School of Medicine. SUBJECTS AND METHODS: Twelve cadaver tracheas were harvested. Each trachea was bifurcated, with 1 segment of each trachea transected and anastomosed using circumferential sutures and the remaining tracheal segment undergoing the same procedure with the addition of cartilaginous reinforcing sutures. Segments (proximal versus distal) were alternated to control for potential anatomic-based strength differences. The force necessary for anastomotic rupture was measured, and a Wilcoxon signed-rank test was used to compare means. RESULTS: Analysis demonstrated the mean anastomotic rupture point for tracheas with reinforcing sutures was 297 N (95% confidence interval = 241.1-352.9), while the mean for trials without reinforcing sutures was 173 N (95% confidence interval = 142.63-203.37; P = .0054). The point of rupture occurred at the anastomosis in 1 case with reinforcing sutures and in 8 of 11 cases without reinforcing sutures. CONCLUSIONS: Cartilaginous reinforcing sutures were found to provide a higher force requirement for tracheal anastomotic rupture when compared with anastomoses without these sutures. This improved stability in tracheal anastomosis may result in a decreased risk of early tracheal rupture after anastomosis.

Ultrasound gel causes fine needle aspiration artifact? A clear choice.

OBJECTIVES: Ultrasound-guided fine needle aspiration (FNA) is a commonly employed tool in cytopathologic practice. Artifacts resulting in misinterpretation of specimens have been noted with various ultrasound gel media. Our purpose was to perform a prospective human cadaveric study of this phenomenon to identify a low-cost solution that eliminates the artifact. STUDY DESIGN: Three separate ultrasound-guided FNAs were performed on the thyroid and parotid glands in situ of a fresh human cadaver using three different types of ultrasound gel media. Slides were prepared in standard fashion (Quik-Diff and Papanicolaou stains). Two cytopathologists subsequently analyzed the slides for the presence of any artifact interfering with their ability to visualize and interpret the cellular aspirate material. RESULTS: Two of the three gel media revealed significant artifacts mimicking apoptosis, necrosis or colloid, making it difficult to visualize the cellular components and differentiate the artifact from the thyroid colloid. One gel medium did not show any significant artifact, and there was no discernable difference in its quality with regard to the ultrasound image during FNA procedures. CONCLUSIONS: Ultrasound gels can be associated with a significant artifact in FNA specimens. To eliminate this artifact, which may alter the adequacy, diagnosis or cytologic appearance, we confirm a specific gel type that is useful for ultrasound-guided FNAs.

Nasal batten grafts: are patients satisfied?

OBJECTIVES: To learn how nasal batten grafts affect patients' assessment of their nasal airway patency and to determine the extent to which patients believe batten grafts altered their appearance. METHODS: A prospective survey study of 18 patients in a tertiary veterans hospital who had nasal airway obstruction (NAO) due to nasal valve collapse was completed. Patients had placement of bilateral polyethylene batten grafts during a 36-month study period. The Nasal Obstruction Symptom Evaluation (NOSE) validated survey was used to measure a patient's subjective postoperative change in nasal airway obstruction. In addition, the patients were asked to rate the extent their appearance had changed. RESULTS: All patients presented with complaints of NAO due to nasal valve collapse either in isolation or in combination with another anatomical source of obstruction. The nasal valve collapse was identified by clinical examination. All patients had preoperative photographs. Most patients had a trial with an intranasal stent before opting for surgical implantation of the batten grafts. The results of the NOSE survey demonstrate significant improvement in nasal obstruction. Patients also reported only a minimal change in appearance. There was 1 patient with implant extrusions and only a few implants were removed. CONCLUSIONS: Nasal airway obstruction due to nasal valve collapse can be effectively treated with polyethylene batten grafts. The implants are well tolerated, and patients report a significant improvement in NAO. There is little risk of implant extrusion, exposure, or intolerance. In addition, patients did not note a significant change to their appearance.

Ultrasound-guided needle aspiration: impact of immediate cytologic review.

OBJECTIVES/HYPOTHESIS: To compare the diagnostic adequacy of ultrasound-guided fine-needle aspiration biopsy (USFNA) of the head and neck with immediate on-site microscopic evaluation and feedback by a cytopathologist (IMMEDIATE) versus delayed examination without immediate feedback (DELAYED). STUDY DESIGN: Retrospective chart review of office-based USFNA performed in both IMMEDIATE and DELAYED settings by the same otolaryngologist. METHODS: A total of 199 USFNA procedures in the head and neck were performed by one practitioner. Of these procedures, 137 biopsies were performed in the DELAYED setting, whereas 62 biopsies were performed in the IMMEDIATE setting. Cytopathology reports were reviewed for diagnostic conclusions as well as adequacy of biopsies. The results from both settings were compared using Pearson χ2 test. RESULTS: The ability to obtain a diagnosis from USFNA was 73.0% in the DELAYED group as compared with 90.3% in the IMMEDIATE group. The rate of adequate cells on biopsy was 89.1% in the DELAYED group as compared with 96.8% in the IMMEDIATE group. There was a statistically significant difference between observed and expected diagnostic rates (χ(2)[1] = 7.568, P = .006) and a trend toward a significant difference between the observed and expected adequacy rates (χ(2)[1] = 3.259, P = .071) when IMMEDIATE evaluation by a cytopathologist was performed. CONCLUSIONS: An immediate microscopic evaluation of USFNA specimens to confirm adequacy of sampling is strongly recommended. Diagnostic conclusions were increased when an evaluation of the specimen was performed at the time of biopsy. The specimen adequacy rate tended to increase with an immediate cytopathologic assessment. Laryngoscope, 2010.

Implications of head and neck cancer treatment failure in the neck.

OBJECTIVE: Study the survival of patients with cervical lymphatic squamous cell carcinoma recurrence. STUDY DESIGN: Review of tumor registry database. SETTING: Academic health science center. SUBJECTS AND METHODS: Forty-seven isolated neck recurrence patients identified from 224 recurrences from a total of 1291 patients treated between 1998 and 2007. The main outcome measurements were neck lymph nodal recurrence, treatment-specific survival, and overall survival. RESULTS: A total of 47 patients had neck recurrence; 10 of the neck recurrence patients (21.3%) had regional disease (N+) at initial presentation. Median survival for patients with neck recurrence was 14.7 months (95% confidence interval [CI] 8.6-18.1 mo), and five-year survival for this group was five percent (95% CI 0%-30%). Neck dissection salvage therapy for neck recurrence resulted in the best survival. CONCLUSION: Neck dissection as a salvage therapy for neck recurrence resulted in the best survival, and there was no survival benefit in terms of whether a patient had a neck dissection or not as his or her initial therapy.

Genetic alterations in papillary thyroid carcinoma and hashimoto thyroiditis: An analysis of hOGG1 loss of heterozygosity.

OBJECTIVES: To determine the relationship between hOGG1 loss of heterozygosity (LOH), Hashimoto thyroiditis (HT), and papillary thyroid cancer (PTC). Hashimoto thyroiditis is an autoimmune mediated chronic inflammatory disease previously shown to coexist with papillary PTC. To further define the relationship between HT and PTC, we report an analysis of hOGG1, a major repair gene for free radical-induced oxidative DNA damages, in thyroidectomy specimens. DESIGN: Tissue samples from 20 cases of PTC, 20 cases of HT, and 15 cases of benign goiter were included in this study. Samples of DNA collected from laser-capture microdissection of thyroidectomy specimens were analyzed for hOGG1 LOH by polymerase chain reaction (PCR) amplification using 5 fluorescent-labeled microsatellite markers followed by fragment analysis. SETTING: A university tertiary care center and regional veterans' hospital. PATIENTS: Fifty-five patients undergoing partial or total thyroidectomies for various indications (PTC, HT, or goiter). INTERVENTIONS: Pathology specimens were analyzed by laser capture microdissection and PCR for hOGG1. MAIN OUTCOME MEASURE: The presence of hOGG1 in all thyroid specimens. RESULTS: Amplification by PCR was successful for all 5 markers in 18 cases of PTC, 15 cases of HT, and 12 cases of benign thyroid. Among these samples, hOGG1 LOH was found in 17 of 18 PTC specimens (94%), 11 of 15 HT specimens (73%), and 1 of 12 benign goiter specimens (8%). CONCLUSIONS: hOGG1 LOH is strongly associated with PTC and HT but not with benign thyroid. We hypothesize that thyroid follicular epithelia accumulate aberrant genetic changes in long-standing HT, which may represent a precursor lesion of PTC.

Increased microsatellite instability and epigenetic inactivation of the hMLH1 gene in head and neck squamous cell carcinoma.

OBJECTIVE: The study is designed to elucidate the relationship between epigenetic silencing of the hMLH1 (human MutL homologue 1) gene and microsatellite instability (MSI) and the prognostic values of hMLH1 promoter methylation and MSI in head and neck squamous cell carcinoma (HNSCC). STUDY DESIGN: Cross-sectional study. SETTING: Tertiary referral center. SUBJECTS AND METHODS: A total of 120 cases of HNSCC were analyzed for hMLH1 promoter hypermethylation, protein expression, and MSI by using methylation-specific polymerase chain reaction, immunohistochemical staining, and polymerase chain reaction amplification with the use of 16 fluorescent-labeled microsatellite markers, followed by fragment analysis. RESULTS: Of 120 HNSCCs, hMLH1 promoter hypermethylation and decreased hMLH1 protein expression were shown in 39 (32.5%) and 22 (18.3%), respectively. hMLH1 promoter hypermethylation was detected in 13 of 52 (25%) normal-appearing squamous mucosa adjacent to invasive carcinoma. MSI was detected in 21 (17.5%) tumors at two or more markers and in 99 (82.5%) tumors with no evidence of MSI or at only one marker. Hypermethylation of the hMLH1 gene is significantly associated with decreased hMLH1 protein expression (P < 0.001). High-frequency MSI was significantly associated with promoter hypermethylation (P = 0.01) but not with decreased protein expression (P = 0.069) of hMLH1 gene. hMLH1 promoter hypermethylation is significantly associated with decreased cause-specific survival for HNSCC patients (P = 0.03). CONCLUSIONS: Promoter hypermethylation of the hMLH1 gene could be detected early in head and neck squamous carcinogenesis and may be associated with increased MSI and poor survival in HNSCC.

In vivo fiber-based multicolor photoacoustic detection and photothermal purging of metastasis in sentinel lymph nodes targeted by nanoparticles.

This report introduces a novel diagnostic and therapeutic platform for in vivo non-invasive detection and treatment of metastases in sentinel lymph nodes (SLNs) at single cell level using an integrated system of multicolor photoacoustic (PA) lymph flow cytometry, PA lymphography, absorption image cytometry, and photothermal (PT) therapy. A melanoma-bearing mouse model was used to demonstrate the capability of this platform for real-time lymphatic mapping, counting of disseminated tumor cells (DTCs) in prenodal lymphatics, and detecting metastasis in SLNs and its purging. The detection and ablation of non-pigmented breast cancer cells in SLNs was achieved by labeling them with nanoparticles. The association between DTC count and SLN metastasis progression supports lymphatic DTCs as a novel prognostic marker of metastasis. The fiber-based portable PA device may replace the conventional SLN(s) excision and histology-based staging. The earliest detection of DTCs in the lymphatic vessels before the establishment of nodal metastasis may prevent metastasis by well-timed ablation of DTCs.

Sculpting resection of rhinophyma using the Shaw scalpel.

BACKGROUND: Rhinophyma is a disfiguring disorder of the nasal skin characterized by hypervascularity, sebaceous gland hyperplasia, occluded sebaceous ducts, and dermal fibrosis. It has no known effective medical treatment; however, a myriad of surgical treatments have been reported. We report an effective, efficient, and safe approach to treat this disorder using the Shaw scalpel to surgically sculpt the nose. OBJECTIVE: To evaluate the efficacy and safety of using the Shaw scalpel to treat rhinophyma. METHODS: We performed a retrospective review of 7 male patients (age range, 58-81 years) who underwent primary surgical treatment of rhinophyma with the Shaw scalpel. RESULTS: A good to excellent outcome was noted in all 7 patients. No perioperative complications occurred. Essentially no blood loss was noted during or after the procedures. CONCLUSION: Use of the Shaw scalpel as the sole surgical instrument and method is a safe, efficient, and effective means to treat rhinophyma.

Appearance-related residual injury, posttraumatic stress, and body image: Associations within a sample of female victims of intimate partner violence.

One third of women who experience intimate partner violence (IPV) receive some form of injury. After acute injuries have healed, a victim's physical appearance may be altered with residual changes including marks or scars. This study included 56 female victims of IPV (31 with appearance-related residual injury and a comparison group of 25 with no appearance-related residual injury) and examined the associations between violence-related experiences, body image distress, and symptoms of posttraumatic stress disorder (PTSD). Appearance-related residual injury status moderated the relationship between body image distress and symptoms of PTSD. In addition, within the appearance-related residual injury group, body image distress emerged a unique predictor of PTSD explaining incremental variance beyond that explained by severity of psychological maltreatment.

Evaluation of the inferior and superior laryngeal nerve stumps for perineural spread in laryngeal cancer.

OBJECTIVE: Perineural spread (PNS) is an important risk factor for locoregional failure and is correlated with reduced survival rates in squamous cell carcinoma of the larynx. PNS may extend proximally and/or distally in the nerve sheath by leaving uninvolved nerve segments. This method of extension may preclude obtaining tumor-free surgical margins, which may be responsible for recurrent disease. The purpose of this study is to investigate the presence or absence of PNS in extralaryngeal superior and inferior laryngeal nerves in patients who underwent total laryngectomy for squamous cell carcinoma of the larynx. METHODS: Extralaryngeal segments of superior and inferior laryngeal nerves were resected bilaterally during 15 consecutive laryngectomies. Laryngectomy specimens and the harvested proximal nerve segments were histopathologically examined for the presence or absence of PNS. RESULTS: Ten of 15 laryngectomy specimens showed PNS; however, none of the extralaryngeal superior or inferior laryngeal nerve segments revealed perineural involvement. CONCLUSION: Extralaryngeal extension of PNS is highly unlikely in squamous cell carcinoma of the larynx.

Methylation status of genes in papillary thyroid carcinoma.

OBJECTIVES: To determine the methylation status of gene promoter regions using methylation-specific polymerase chain reaction in genes encoding for thyrotropin receptor (TSHR), E-cadherin (ECAD), sodium iodide symporter protein (NIS-L), ataxia telangiectasia mutated (ATM), and death-associated protein kinase (DAPK) proteins and if methylation status correlates with patient variables, tumor factors, or outcome measures among patients with papillary thyroid carcinoma. DESIGN: Database query and retrospective medical chart review for patients with well-differentiated thyroid cancer and nonmalignant thyroid conditions treated at our institutions (1996-2004). Methylation-specific polymerase chain reaction was performed, and results were compared with controls for these genes. Methylation status was then compared with patient variables, tumor factors, and outcome measures for patients with thyroid carcinoma and controls. PATIENTS: The study population comprised 32 patients with papillary thyroid carcinoma and 27 controls. RESULTS: In our patients, all 5 genes were methylated more frequently in papillary thyroid carcinoma than in controls. NIS-L trended toward a more advanced stage at presentation. NIS-L methylation in cancer cells was not associated with methylation in adjacent benign tissue, unlike the other 4 genes. Neither age nor sex affected methylation status, and methylation status did not correlate with extent of the primary tumor or presence of nodal metastasis at diagnosis. Tumors recurred less frequently in patients with TSHR methylation than in patients with unmethylated TSHR promoter regions. CONCLUSIONS: Promoter methylation may be a marker for malignancy in thyroid carcinoma. Furthermore, methylation status of tumors as determined by methylation-specific polymerase chain reaction may help in determining patient prognosis.