Consortium of otolaryngology--head and neck surgery journals to collaborate in maintenance of high ethical standards.
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Biomedical subjects
Publications and source records attributed to Jonas T Johnson.
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OBJECTIVE: The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted with the long-term goal of improving the efficiency and effectiveness of health care. It has created sweeping changes for clinical medicine and research. Generally, the standards for privacy of individual, identifiable health information (the privacy rule) require patient consent before their protected health information (PHI) can be employed in clinical research. This rule requires that all patients sign an IRB approved informed consent before their identifiable clinical information can be aggregated with the information from other patients. This rule has been applied to ensure the privacy of health care data accrued previously. Accordingly, investigators have been blocked from using the aggregate data from prior clinical records and registries until consent is obtained from living, former patients. At the University of Pittsburgh Department of Otolaryngology, a clinical tumor registry was established in 1982. These data have served as the basis for over 200 publications reflecting practice-based learning. The present study quantifies the cost of HIPAA compliance to maintain access to our faculty's career-long clinical activities and to stress to all physicians the importance of research registries as a means of protecting their own career's work. RESULTS/CONCLUSIONS: Compliance with the privacy rule required that written, informed consents be mailed to 14,330 former patients. This resulted in direct costs of more than $30,888. The practical and financial impact of HIPAA on clinical research and our departmental solutions to these challenges are discussed.
The history and physical examination, computed tomography (CT) and magnetic resonance imaging are the cornerstones for identifying new and recurrent cancers of the head and neck. The advent of positron emission tomography (PET) and combined PET/CT imaging technology is a promising development. These modalities have the potential to help stage patients presenting with head and neck cancer, identify responses to nonsurgical therapy, and allow earlier detection of recurrence in the hope of improving survival. The following paper provides a brief history of PET and PET/CT imaging. The current PET and PET/CT literature for squamous cell carcinoma of the head and neck is reviewed, and specific recommendations for its use are provided.
PURPOSE: To prospectively determine whether combined positron emission tomography (PET) and computed tomography (CT) is more accurate than either PET or CT alone in depicting malignant lesions in the head and neck. MATERIALS AND METHODS: Study was approved by the institutional review board, and patient informed consent was waived. Sixty-five consecutive patients (42 men, 23 women; age range, 43-83 years) known to have or suspected of having head and neck cancer were examined with combined PET/CT. CT was performed with intravenous administration of a contrast agent, and the CT data were used for attenuation correction. Each examination was interpreted in three ways: PET images in the absence of CT data, CT images in the absence of PET data, and fused PET/CT images. Probability of malignancy of each lesion was assigned a score by using a five-point scale. Receiver operating characteristic (ROC) analyses were performed by using biopsy, imaging, or clinical follow-up as the reference standard. The minimum follow-up was 6 months (range, 6-12 months). The results were additionally analyzed to assess the degree of radiologist confidence. RESULTS: Follow-up was available for 64 (98%) of 65 patients. ROC analyses demonstrated that PET/CT is significantly superior to PET or CT alone for depiction of malignancy in the head and neck (P < .05). In this series, PET/CT had a sensitivity of 98%, a specificity of 92%, and an accuracy of 94%. Radiologist confidence was substantially higher with the combined modality. CONCLUSION: Combined PET/CT is more accurate than PET or CT alone for the depiction of malignancy in the head and neck. Radiologist confidence is improved with the combined modality.
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OBJECTIVE: Apoptosis of T lymphocytes in the circulation of patients with squamous cell carcinoma of the head and neck (SCCHN) was shown to target effector CD8+ rather than CD4+ T cells. This study evaluates the contribution of pro- and antiapoptotic components of the mitochondria-dependent pathway to apoptosis of circulating CD8+ T cells in these patients. EXPERIMENTAL DESIGN: Blood samples were obtained from 77 patients with SCCHN and 51 normal control(s) (NC). Percentages of CD8+Annexin V+ (ANX+) and CD8+CD95+ cells, changes in mitochondrial membrane potential and levels of expression of Bcl-2, Bcl-XL, and Bax in CD8+ T lymphocytes were measured by quantitative flow cytometry. RESULTS: Elevated percentages (P < 0.001) of early apo-ptotic (CD8+ANX+ CD95+) T cells in the circulation distinguish SCCHN patients from NCs but not patients with no evidence of disease (NED) from those with active disease (AD). Circulating CD8+ but not CD4+ T cells in patients were found to contain higher levels of proapoptotic Bax and antiapoptotic Bcl-XL (P < 0.01) than NC cells. The Bax/Bcl-2 ratio was elevated in CD8+ T cells of patients relative to NCs (P < 0.01), and it correlated with the percentage of ANX+CD8+ T cells (P = 0.007). The Bax/Bcl-XL ratio discriminated AD from NED patients. CONCLUSION: Apoptosis of circulating CD8+T cells is found in SCCHN patients with AD or NED. Up-regulated Bax and Bcl-XL expression, the elevated Bax/Bcl-2 ratio and its association with ANX binding implicate the mitochondrial pathway in death of CD8+ T cells of patients with SCCHN. Understanding of molecular mechanisms of T-cell death and survival is essential for the development of more effective biotherapies for SCCHN.
PURPOSE: Survival in patients with Stage IV carcinoma of the base of tongue (BOT) treated by surgery and radiotherapy remains poor. External beam radiotherapy (EBRT) and brachytherapy (BT) have been used as an alternative treatment. METHODS AND MATERIALS: Eighteen patients with Stage IV carcinoma of the BOT were treated by EBRT and BT. RESULTS: Local control is 89%. The 5-year overall (OS) and disease specific survival (DSS) rates are 52% and 67%. No neck node positive patient implanted in the neck developed cervical metastases. Two patients (11%) developed complications. CONCLUSIONS: Local regional control, survival, and complications in patients with Stage IV carcinoma of the BOT treated by EBRT and BT have been satisfactory. The use of brachytherapy for nodal metastases has eliminated the need for neck dissection. We recommend this approach in the treatment of Stage IV carcinoma of the BOT.
OBJECTIVE: Our goal was to assess disease-specific quality of life outcomes after nasal septoplasty in adults with nasal obstruction. DESIGN, SETTINGS, AND PATIENTS: We conducted a prospective observational outcomes multicenter study with 14 sites and 16 investigators, including private practice and academic settings. Patients had had septal deviation and symptomatic nasal obstruction for at least 3 months, and medical management had failed. METHODS: Patients with septal deviation completed a validated outcomes instrument (the Nasal Obstruction Septoplasty Effectiveness [NOSE] scale) before and 3 and 6 months after septoplasty, with or without partial turbinectomy. RESULTS: Fifty-nine patients underwent surgery; there was a significant improvement in mean NOSE score at 3 months after septoplasty (67.5 versus 23.1, P < 0.0001), and this improvement was unchanged at 6 months. Patient satisfaction was very high, and patients used significantly fewer nasal medications. CONCLUSIONS: In patients with septal deformity, nasal septoplasty results in significant improvement in disease-specific quality of life, high patient satisfaction, and decreased medication use.
OBJECTIVE: In a previous study, we reported that the contralateral undissected neck was the most common site of failure in patients treated for squamous cell carcinoma of the supraglottic larynx. Since then, we have altered our treatment of all patients with T2-T4 supraglottic cancer and selective T1 cases to include routine bilateral neck dissection. In the present study, we compare the long-term efficacy of routine bilateral neck dissections to historic controls in the treatment of patients with supraglottic cancer. STUDY DESIGN AND SETTING: A retrospective chart review on all patients undergoing primary surgery for supraglottic carcinoma between 1989 and 2000 was performed. All had undergone routine bilateral neck dissection. The most proximal area of recurrent disease was identified as the site of recurrence. Rates of recurrence, 2-year overall survival, and 2-year disease-specific survival were calculated. Results were compared to historical data using Fisher's exact test. RESULTS: Of 180 patients identified, 115 patients with minimum 2-year follow-up and meeting exclusion criteria were included in the analysis. Four patients (3.5%) experienced local recurrence, 9 patients (7.8%) had cervical recurrence, and 8 patients had distant spread (7.0%). Recurrence in the neck (7.8%) has been significantly reduced from the historical recurrence rate (20%) prior to instituting routine bilateral neck dissections ( P = 0.009). The 2-year survival increased from 72% to 82.6% ( P = 0.0408). CONCLUSION AND SIGNIFICANCE: Routine bilateral neck dissection decreases cervical recurrence and appears to improve survival in the management of supraglottic cancer.
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Nasopharyngeal actinomycosis is a rare clinical disease. It can occur after nasal trauma or surgical manipulation. It is also reported to occur without prior trauma, making diagnosis difficult. We report a case of nasopharyngeal actinomycosis that presented as nasal airway obstruction causing snoring and mimicking nasopharyngeal carcinoma. To our knowledge, only a few other cases of nasopharyngeal actinomycosis have previously been published, most coming after mucosal trauma. Diagnosis is made by observing the bacteria or its associated sulfur granules in the biopsy specimen. This anaerobic organism is difficult to culture. Treatment consists of wide debridement and prolonged antibiotic therapy, with good prognosis.
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OBJECTIVE/HYPOTHESIS: The utility of elective neck dissection in the management of patients with oral cavity and oropharyngeal cancer who present without neck metastases remains controversial. The study addressed the question of whether elective neck dissection improves regional control and survival in patients with squamous cell carcinoma of the oral cavity and oropharynx presenting with T1/T2 node-negative disease. STUDY DESIGN: A nonrandomized, uncontrolled retrospective chart review. METHODS: A nonrandomized, uncontrolled retrospective chart review was performed. Resection of the primary tumor was performed in all patients. The neck was observed in one group, and elective neck dissection was performed for patients in another group. RESULTS: The study data indicated that elective neck dissection significantly improves regional control and regional recurrence-free survival. Elective neck dissection when compared with observation of the neck did not improve overall survival. CONCLUSION: Elective neck dissection reduces regional recurrence and may extend disease-free survival.
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OBJECTIVE: The study goal was to evaluate the use of combined positron emission tomography/computed tomography (PET/CT) imaging for localization of recurrent disease in thyroid cancer patients. STUDY DESIGN AND SETTING: Eight patients with suspected recurrence of thyroid cancer on the basis of elevated serum thyroglobulin or calcitonin levels underwent combined PET/CT imaging on a prototype device. All 8 patients had previously undergone total thyroidectomy and (131)I ablation for thyroid carcinoma. Patients with papillary carcinoma had negative (131)I scans. RESULTS: Eight patients underwent combined PET/CT scanning. Four (50%) of 8 patients underwent PET/CT indicating recurrence in the head and neck. A total of 11 lesions in these 4 patients were suspicious for recurrence on combined PET/CT imaging. Three patients with 8 lesions suspicious for recurrence on PET/CT underwent surgical removal of disease. All 3 patients had pathologic confirmation of recurrence, with 6 (75.0%) of 8 lesions being positive. CONCLUSION: Combined PET/CT imaging is a valuable tool for the diagnosis and anatomic localization of recurrent thyroid cancer.
OBJECTIVE: To analyze quality of life, functional outcome, and hidden costs by primary treatment with surgery or radiation therapy in patients with early glottic cancer. STUDY DESIGN: Retrospective study in a tertiary care facility. METHODS: A group of 101 patients with carcinoma in situ and T1 invasive squamous cell carcinoma treated primarily with either surgery or radiation, between January 1990 and December 2000, were identified from searching our tumor registry. Patients completed two previously validated questionnaires and one local questionnaire. Statistical significance was assessed with the rank sum test, chi2 test, or Fisher's Exact test. RESULTS: Questionnaires were completed in 59% (44 of 74) of the surgical cohort and 41% (11 of 27) of the radiation therapy cohort. The primary surgical treatments were endoscopic excision (86%), hemilaryngectomy (12%), and total laryngectomy (1%). Patient-reported problems with swallowing, chewing, speech, taste, saliva, pain, activity, recreation, and appearance showed no difference between the endoscopic excision or radiation therapy cohorts. Comparing endoscopic excision versus radiation therapy, respectively, median number of treatments (2 vs. 35), total median travel distance (150 vs. 660 miles), total median travel time (180 vs. 1440 min), and total median number of hours of work missed (76 vs. 24) all differed significantly (P <.01). CONCLUSIONS: Almost all patients with early glottic cancer, whether treated with surgery or radiation therapy, reported excellent quality of life outcomes and functional results. In addition to actual costs, the hidden costs for radiation therapy versus endoscopic excision were all greater in terms of total number of hours of work missed, total travel time, and total travel distance.