Literature Review: A roundup of the most important recent studies

From: ENT Today, May 2010

by Michael G. Stewart, MD,MPH; Sue Pondrom

• New OSA Clinical Guideline
• Secondhand Smoke Increases Chronic Rhinosinusitis Risk
• Trial Assesses Shorter Moxifloxacin Therapy
• The Internet Says I’m Attractive
• Caution Regarding Elective Neck Dissection During Salvage Surgery
• MRI Useful for Identification of Sudden Sensorineural Hearing Loss Etiology

 

New OSA Clinical Guideline

Clinical Question

What is the current recommended standard for evaluation and treatment of sleep-disordered breathing and obstructive sleep apnea (OSA)?

Background: There is lack of consensus about diagnostic protocols for OSA in adults. This multicenter, multispecialty clinical guideline summarizes the best evidence and makes a series of clinical recommendations, with associated strength of recommendation depending on the underlying supportive evidence.

Study Design: Consensus clinical guideline

Setting: N/A

Synopsis: This guideline is rich with helpful algorithms and lists of important criteria and can serve as a reference. Key recommendations are as follows:

Key screening questions are history of snoring and daytime sleepiness. Screening examination should include evaluation for obesity, retrognathia or hypertension. Positive screening findings should lead to comprehensive evaluation, including snoring, witnessed apnea, gasping/choking episodes and excessive sleepiness.

There is no clinical model that consistently predicts the severity of OSA. Diagnostic testing, therefore, is required. This can include in-laboratory polysomnography (PSG) or at-home testing with a portable monitor (PM). PMs can be used in patients with a high pretest likelihood of moderate or severe OSA; however, because the denominator is total recording time rather than total sleep time, PMs are likely to underestimate the severity of OSA. PSG testing is indicated in patients with possible mild apnea, with any comorbidity or before bariatric surgery.

Treatment of OSA is complicated and multifactorial and should include some combination of behavioral options, positive airway pressure, oral appliances or surgical treatment. Surgical treatment tends to be more effective at improving non-PSG outcomes, such as sleepiness, quality of life and functional status, but often does not result in resolution of OSA by PSG criteria.

Bottom Line: OSA should be screened and tested for. The diagnosis is dependent on a combination of symptoms and sleep study findings. In some circumstances, an unattended at-home study is adequate for diagnosis of OSA.

Reference: Epstein LJ, Kristo D, Strollo PJ II, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263-276.

—Reviewed by Michael G. Stewart, MD, MPH

 

Secondhand Smoke Increases Chronic Rhinosinusitis Risk

Clinical Question

Is exposure to secondhand smoke a risk factor for chronic rhinosinusitis (CRS)?

Background: There are surprisingly few studies that address the association between secondhand smoke (SHS) and sinusitis, and most use fairly weak criteria for sinusitis, such as a patient’s having checked “sinusitis” on a health questionnaire. There are, however, several studies that address the effects of SHS on lower airway diseases such as asthma and bronchitis.

Study Design: Population-based case-control study

Setting: A long-term population cohort study in Washington County, Md.

Synopsis: The authors found that either current or childhood exposure to SHS—or both—increased the risk of symptoms of CRS (odds ratio=2.33, 95 percent confidence interval=1.02 – 5.34, p=0.05). In addition, among patients with CRS, those with SHS exposure had significantly worse mean symptom scores than patients with CRS and no SHS exposure (obstruction: 3.1 vs. 2.5, p=0.02; discharge: 3.3 vs. 2.7, p=0.03). Therefore, SHS exposure is likely associated with both causation and also exacerbation or severity of CRS.

The methodology of this study is particularly good and rarely used in otolaryngology. The data are from a well-documented cohort study that has been collecting data over many years. The authors have performed a true case-control study, identifying cases and matched controls from the cohort and performing a classic case-control analysis.

The authors also reviewed the literature on this topic, covering studies on both SHS and active smoking. Studies on the effects of current smoking are stronger, include specialist diagnosis and radiologic confirmation and note an association between smoking and CRS.

Bottom Line: Current or past exposure to SHS increases the risk and potential severity of symptoms of CRS.

Reference: Reh DD, Lin SY, Clipp SL, et al. Secondhand tobacco smoke exposure and chronic rhinosinusitis: a population-based case-control study. Am J Rhinol Allergy. 2009;23(6):562-567.

—Reviewed by Michael G. Stewart, MD,MPH

 

Trial Assesses Shorter Moxifloxacin Therapy

Clinical Question

What is the efficacy and safety of a five-day moxifloxacin regimen in the treatment of acute bacterial rhinosinusitis (ABRS)?

Background: There is a lack of clarity regarding the role of antimicrobials in ABRS treatment. Although current guidelines encourage the use of antimicrobials, it is difficult to identify appropriate patients. Additionally, there would be benefits to reducing treatment duration, including lower drug exposure, greater compliance and minimized potential for resistance.

Study Design: A prospective, randomized, multicenter, 2:1 double-blind, phase IIIb clinical trial

Setting: Thirty-seven centers (ear, nose and throat practices; family practitioners; and general medical clinics) in the U.S.

Synopsis: Microbiologic assessment was provided at enrollment for 374 patients with ABRS who were given 400 mg of oral moxifloxacin or a matching placebo daily for five days. The primary end point was clinical response with secondary efficacy variables, including patient-reported symptom improvement. Although moxifloxacin did not show clinical superiority to placebo in the modified intent-to-treat (mITT) population, it did reduce the rate of clinical failure by 42.3 percent compared with placebo, and symptom duration was shorter in moxifloxacin-treated patients, who experienced greater and faster improvements overall. However, the authors said the study may have been affected by confounding factors. For example, the study was not sufficiently powered to detect a difference from placebo with a greater than estimated success rate, patients with nonbacterial sinusitis may have been included, the high use of concomitant medications in the placebo arm may have masked continuing sinusitis symptoms, the use of a sinus tap may have had an adjunctive effect on bacterial clearance and, because an arbitrary point for analysis is problematic, the test-of-cure visit may have been too early.

Bottom Line: Although five-day moxifloxacin did not show clinical superiority to placebo, researchers noted positive trends favoring moxifloxacin when assessing secondary efficacy variables, such as symptom relief. Patients on moxifloxacin also used fewer concomitant medicines.

Reference: Hadley JA, Mösges R, Desrosiers M, et al. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010;120(5):1057-1062.

—Reviewed by Sue Pondrom

 

The Internet Says I’m Attractive

Clinical Question

Can facial attractiveness scores obtained from an Internet-based rating system correlate with and be an alternative for those accrued from the traditional focus group method?

Background: Despite the extensive number of facial beauty studies, research has been unable to define facial beauty with more specific parameters. A significant limitation is the tedium and difficulty of obtaining large focus groups. Additionally, these groups can be biased with regard to social, economic, cultural, age and other factors.

Study Design: Statistical evaluation of Internet-based facial attractiveness ratings of synthetic facial portraits compared to traditional focus group ratings

Setting: Researchers from the University of California, Irvine utilized focus groups and the Internet site Hotornot.com.

Synopsis: With eight months of extensive logistical planning, 120 synthetic images were evaluated for facial attractiveness using traditional focus groups composed of beauticians trained in media concepts of facial beauty, otolaryngologists with a clinical knowledge of facial analysis and students without specific education in the field. The free website Hotornot.com was selected for the Internet portion of the study because it receives heavy traffic, automatically updates scores (with an average of 857 rates after only 21 days) and has a user-friendly interface. Rater count was increased an average of almost nine-fold, there were no logistical or monetary hurdles and very limited planning was involved. Comparing the two rating systems, the researchers found a strong and positive linear correlation, indicating that both methods agree on which portraits are more or less attractive than others. Limitations to the Internet approach included the unknown demographics of the raters, as well as possible sampling biases. However, these biases were also present in the traditional method and were reduced by accruing a large sample size.

Bottom Line: An Internet-based facial attractiveness rating system is an accurate and faster alternative to the inefficient traditional focus group rating method and can greatly increase the number and demographic variability of raters.

Reference: Devcic Z, Karimi K, Popenko N, et al. A Web-based method for rating facial attractiveness. Laryngoscope. 2010;120(5):902-906.

—Reviewed by Sue Pondrom

 

Caution Regarding Elective Neck Dissection During Salvage Surgery

Clinical Question

Is elective neck dissection the optimal management of the node-negative (N0) neck during salvage surgery after initial treatment with elective nodal irradiation (ENI)?

Background: When the neck is seeded at the time of squamous cell carcinoma recurrence, there is a likelihood of occult regional metastatic disease. While it is common practice to include an elective neck dissection as part of the salvage procedure, dissection after radiotherapy has been associated with decreased quality of life, increased operative time and the potential for increased complications.

Study Design: Retrospective patient chart review with comparison of toxicity and actuarial outcomes

Setting: University of Florida, Gainesville, Florida

Synopsis: Researchers reviewed the medical records of 57 patients who were treated with ENI from 1965 to 2006 for TI-4 N0 M0 squamous cell carcinoma of the oropharynx, hypopharynx or larynx, developed an isolated local recurrence and remained N0. Forty patients were salvaged with neck dissection and 17 with neck observation. In the dissected group, the five-year local-regional control rate was 75 percent for all patients, but neck dissection resulted in poorer outcomes compared with observation. In the dissected group, local control, regional control, cause-specific survival and overall survival rates were 71 percent, 87 percent, 60 percent and 45 percent respectively, compared to 82 percent, 94 percent, 92 percent and 56 percent respectively for the observed group. Toxicity was more likely with dissection, including a 5 percent rate of fatal complications, increased fistula formation, wound complications and longer postoperative hospital admission. Limitations to the study were that the patient population was highly selected and should not be generalized to other recurrent settings. The analysis, for example, involved patients treated over a 40-year period and included a significant treatment-selection bias. In addition, the patients salvaged with neck dissection were more likely to have advanced recurrences.

Bottom Line: Routine elective neck dissection should not be included during salvage surgery for locally recurrent head and neck squamous cell carcinoma if initial radiotherapy included ENI.

Reference: Dagan R, Morris CG, Kirwan JM, et al. Elective neck dissection during salvage surgery for locally recurrent head and neck squamous cell carcinoma after radiotherapy with elective nodal irradiation. Laryngoscope. 2010; 120(5):945-952.

—Reviewed by Sue Pondrom

 

MRI Useful for Identification of Sudden Sensorineural Hearing Loss Etiology

Clinical Question

What is the evidence for different etiologies of sudden sensorineural hearing loss (SSNHL)?

Background: The incidence of SSNHL has been estimated from five to 20 per 100,000 persons per year, but the causes are speculative and probably multifactorial. While identifying the most commonly reported etiologies of SSNHL, the ultimate goal of this study was to develop an evidence-based approach to patient evaluation.

Study Design: Literature and database review

Setting: Researchers from Alberta and British Columbia reviewed databases and 144 research papers.

Synopsis: The review included MEDLINE from 1950-October 2009, EMBASE from 1980-October 2009 and evidence-based medicine (EBM) databases, in addition to a manual reference search of identified papers. Multiple SSNHL patient etiologies were identified, including viral infection, vascular impairment, autoimmune disease, inner ear pathology and central nervous system anomalies.

A second group of papers evaluated patients with specific diagnostic tests, including autoimmune markers, hemostatic parameters and diagnostic imaging. The suspected etiologies were 71 percent idiopathic, 12.8 percent infectious disease, 4.7 percent otologic disease, 4.2 percent trauma, 2.8 percent vascular or hematologic, 2.3 percent neoplastic and 2.2 percent other.

The authors said their review did not identify a specific laboratory test or marker for sudden hearing loss, but they recommended an MRI for diagnostic evaluation. Additionally, the team recommended a directed clinical history and physical examination to identify causes, in addition to routine laboratory screening and screening for certain infectious agents. Study limitations included the lack of a standard SSNHL definition, and the authors said they were unable to pursue negative or unpublished data by the authors of included and excluded studies.

Bottom Line: Establishment of a direct causal link between sudden sensorineural hearing loss and its etiologies remains elusive, with idiopathic the most commonly identified. Diagnostic imaging is a useful method for identification of temporal bone or intracranial pathology that can present with SSNHL as a primary symptom.

Reference: Chau JK, Lin JRJ, Atashband S, et al. Systematic review of the evidence for etiology of adult sudden sensorineural hearing loss. Laryngoscope. 2010;120(5):1011-1021.

—Reviewed by Sue Pondrom

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