Reporting of harms and adverse events in otolaryngology journals.

OBJECTIVE: To identify the frequency and quality of harms and adverse events reporting in otolaryngology journals. STUDY DESIGN: A literature review. METHODS: Four major otolaryngology journals from 2006 and 1996 were reviewed. Clinical research studies offering therapeutic recommendations were evaluated for frequency and quality of harms and adverse events reporting. RESULTS: Of 1,835 total articles reviewed, 576 (31%) offered therapeutic recommendations. Sixty-five percent provided any mention of harms or adverse events, 47 percent explicitly defined the events, and 24 percent described methodology for collecting harms data. The median number of harms or adverse events reported was three. Studies concluding a beneficial effect of therapy were more likely to not mention adverse events (odds ratio 2.99, P = .007) compared with studies concluding no benefit. Studies of surgical therapy were more likely to report harms or adverse events (odds ratio 1.46, P = .046). CONCLUSIONS: Harms and adverse events are underreported and poorly described in otolaryngology journals with about one third of clinical research not mentioning adverse events at all. Most authors do not explicitly describe harms or adverse events (53%) or the methodology behind collecting adverse events data (76%). Underreporting is more likely when a therapeutic effect is found to be beneficial.

Mucoepidermoid carcinoma arising in a background of sialadenoma papilliferum: a case report.

Sialadenoma papilliferum is a rare tumor, primarily of minor salivary gland origin, first described by Abrams and Finck (Cancer 24:1057-63, 1969). It is both an exophytic and endophytic papillary lesion histologically resembling syringocystadenoma papilliferum of sweat gland. The tumor is considered benign although rare recurrent cases have been reported. Three cases of malignant transformation of sialadenoma papilliferum have been described in the literature. We report a high grade mucoepidermoid carcinoma arising in a background of sialadenoma papilliferum, at the base of the tongue, an unusual location for minor salivary gland neoplasms. Eleven months after excision and nodal dissection, there is no evidence of recurrence or metastasis.

B-type natriuretic peptide: a biomarker for the diagnosis and risk stratification of patients with septic shock.

BACKGROUND: The importance of cardiomyocyte damage during sepsis has been a recent subject of interest. The progression of sepsis results in the upregulation of proinflammatory cytokines, which act in concert to damage cardiomyocytes and produce cardiac contractile dysfunction. B-type natriuretic peptide (BNP) is a neurohormone released from the ventricles of the heart in response to myocardial dysfunction. The goal of this study was to examine the relationship between BNP levels and the severity of sepsis independent of congestive heart failure. DESIGN: Prospective, nonrandomized control study. SETTING: University hospital. PATIENTS: Forty-nine patients were divided into 3 groups: 13 patients with septic shock, 18 with early sepsis, and 18 age-matched healthy control subjects. We excluded patients with septic shock who had comorbid conditions (congestive heart failure or renal failure); sepsis severity was determined using the Sequential Organ Failure Assessment scoring system. Patients with sepsis were followed up for 21 days. MAIN OUTCOME MEASURES: Serum BNP levels, determined at the time of diagnosis of sepsis and on patient improvement or deterioration. RESULTS: Patients with septic shock had significantly higher BNP levels on admission compared with the other 2 groups (P < .05). The BNP levels were not significantly elevated in patients with early sepsis. Plasma BNP levels for patients with septic shock were positively correlated with Sequential Organ Failure Assessment scores (r(2) = 0.74, P < .05) and prognosticated survival. CONCLUSIONS: This study confirms the relationship between BNP level elevation and severity of sepsis independent of congestive heart failure. It also supports the utility of BNP level as a marker for mortality in septic shock.