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Literature Review: A Roundup of Important Recent Studies

Oral Steroids in Chronic Rhinosinusitis

What is the evidence to support the use of oral steroids in the management of chronic rhinosinusitis with or without polyps?

Background: Oral steroids are used frequently by otolaryngologists to assist in the management of chronic rhinosinusitis with polyps (CRSwP) or without polyps (CRSsP). Data to support this use, however, is unclear.

Study design: Systematic evidence-based literature review with iterative author assessment.

Setting: Academic medical centers.

Synopsis: The authors divided their review into assessments of oral steroid use in CRSwP, CRSsP and allergic fungal sinusitis (AFS), as well as peri-operative use of steroids in each category. Evidence was found to be strongest for steroid use in short term management of CRSwP with an overall assessment of “strong recommendation,” while in AFS they were “recommended.” Similarly, oral steroids were “strongly recommended” in the perioperative period for CRSwP and AFS. With insufficient strong evidence, oral steroids were thought to be “optional” in short-term management of CRSsP, while “no recommendation” was made for their use in the peri-operative period for CRSsNP.

Bottom line: Evidence supporting the use for oral steroids in the management of CRS is strongest in the presence of polyps and AFS, and their use is strongly recommended. Evidence is not as strong for their use in CRSsP, however, and their use remains optional. They are also recommended in the perioperative management of CRSwP and AFS.

Citation: Poetker DM, Jakubowski LA, Lal D, Hwang PH, Wright ED, Smith TL. Oral corticosteroids in the management of adult chronic rhinosinusitis with and without nasal polyps: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013;3:104-120.

—Reviewed by Brent Senior, MD

Macrolide Therapy for Chronic Rhinosinusitis

What is the evidence to support the use of long-term macrolide therapy for management of chronic rhinosinusitis (CRS)?

Background: CRS, a disorder of chronic inflammation, frequently responds well to anti-inflammatory medications such as steroids. Macrolides are a unique class of antimicrobial that exhibit anti-inflammatory activity and have been advocated for treatment of CRS.

Study design: Systematic literature review of EMBASE and PubMed databases.

Setting: Department of Otolaryngology, University of Michigan Health System; Section of Otolaryngology, Dartmouth-Hitchcock Medical Center; Department of Otolaryngology, University of Washington.

Synopsis: A total of 1,216 citations were screened by a single author, yielding 23 full text articles for review by two authors. Three prospective clinical studies were identified and included in the final review. The studies differed in selection of macrolide drug, dosing and duration of treatment, while comparator groups also differed, with one study comparing against amoxicillin/clavulanate and two studies comparing against placebo. Overall meta-analysis revealed only one statistically significant, but likely clinically insignificant, improvement in the validated Sino-Nasal Outcome Test (SNOT) scale at 24 weeks. Improvement in unvalidated patient response scales was difficult to assess in light of significant heterogeneity between studies and the potential bias within unvalidated instruments.

Bottom line: The three studies included in this review do not demonstrate evidence for a clinically significant impact of long-term macrolide therapy for treatment of CRS. However, there may be an effect among the subgroup of patients with low serum IgE, though further study is warranted.

Citation: Pynnonen MA, Venkatraman G, Davis GE. Macrolide therapy for chronic rhinosinusitis: a meta-analysis. Otolaryngol Head Neck Surg. 2013;148:366-373.

—Reviewed by Brent Senior, MD

Parotid Gland Lymphoma Consideration in Parotid Lesion Evaluation

Are demographic, clinical and pathologic features of patients with parotid gland lymphoma important for prognosis?

Background: To date, there has not been an analysis of prognostic features of parotid lymphoma using U.S. population data. Non-Hodgkin lymphoma (NHL) accounts for 89 percent of all new cases of lymphoma, while Hodgkin lymphoma (HL) accounts for 11 percent of cases. Otolaryngologists usually assist with diagnosis for patients with parotid masses. This study was designed to examine important demographic, clinical, surgical and pathologic factors that affect survival of patients with parotid gland lymphoma.

Study design: Retrospective cohort study.

Setting: Study of 2,140 patients between 1973 and 2008 using the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER).

Synopsis: Surveyed patients had a mean age of 64.1 ± 16.8 years, and the number of cases increased with age. Women represented 57.4 percent of cases, and 85.5 percent of surveyed patients were white. Nearly all cases were NHL, and the most common NHL subtypes were marginal zone B-cell lymphoma (27.9 percent), follicular lymphoma (25.8 percent) and diffuse large B-cell lymphoma (23.7 percent). Most surveyed patients presented with stage I (49.8 percent) and stage II (21.0 percent) disease. The majority of patients (71.4 percent) received some kind of surgical procedure (associated with a 35 percent lower risk of death); the most common procedure was parotidectomy (75.7 percent). Radiation was given to 39 percent of patients and was associated with improved survival. In addition, patients diagnosed between the years 2000 and 2008 had a 37 percent lower risk of death. Those with stage IV disease had 1.58 times the risk of death compared with those who had stage I disease. Median survival time was determined for stages I (12.3 years), II (9.1 years), III (8.3 years) and IV (8.0 years); HL patients had the longest survival. The risk of death from parotid lymphoma increased with age, gender and disease stage. Limitations included lack of detailed clinical information within SEER and lack of reliably recorded chemotherapy data.

Bottom line: Primary lymphoma of the parotid gland, although uncommon, is important to consider during parotid lesion evaluation and treatment.

Citation: Feinstein AJ, Ciarleglio MM, Cong X, Otremba MD, Judson BL. Parotid gland lymphoma: prognostic analysis of 2,140 patients. Laryngoscope. 2013:123:1199-1203.

—Reviewed by Amy Eckner

Better Dialogues with Patients May Minimize Liability in Cranial Nerve Injury Malpractice Trials

Can knowledge of factors that affect outcomes in cranial nerve (CN) malpractice trials help physicians develop strategies to reduce professional liability and improve medical outcomes?

Background: Direct costs for health care professionals associated with malpractice litigation are estimated at between $6.5 and $10 billion per year. To date, there have been no analyses of litigation regarding CN I, II, III, IV, V, VI, VIII, IX, XII or any associated branches. Trials were examined for characteristics including nerve(s) injured, alleged causes, location, patient demographics, procedure and defendant specialty and outcome, among others. Out-of-court settlements were not considered, but the mean settlement amount was lower than the mean verdict award.

Study design: Retrospective analysis of jury verdict reports related to medical malpractice and CN injury.

Setting: The Westlaw database (Thomson Reuters, New York, N.Y.) was used to examine 209 trials; American Association of Medical Colleges figures were used to determine the number of practicing surgeons per state.

Synopsis: Average plaintiff age was 47.2 years, with 55 percent female; trial years ranged from 1984 to 2011. The most commonly litigated CN cases involved the facial (24.4 percent) and optic (19.6 percent) nerves; damages for optic nerve cases were higher than for all other CNs. The most frequently litigated nerves were CN VII, II, X and XI, respectively; there were no trials for CN IV, VI and IX. Recurrent laryngeal nerve damage was found in 96.9 percent of CN X cases. Damages were awarded in 33 percent of trials. The most commonly named defendants were otolaryngologists (26.3 percent) and general surgeons (17.7 percent). The highest CN malpractice case frequencies were found in Missouri, California, Ohio, Rhode Island and Alaska. The highest mean jury awards were for optic nerve injury ($3.1 million). Factors most frequently present were alleged informed consent defects (25.4 percent), complications requiring surgery (25.8 percent) and failure to recognize complications in a timely way (23.9 percent). For informed consent defects, specific complications not being mentioned as possibilities and “non-adverse” outcomes that make patients unhappy (e.g., cosmetic deformities) can result in litigation. Study limitations included variability of detail level and type among cases, and some voluntarily submitted Westlaw records rather than federal and state court records.

Bottom line: Knowing these factors, physicians should have clear conversations with patients regarding complications and outcomes, and may want to consider out-of-court settlements when adverse factors to judgments in favor of defendants are present.

Citation: Svider PF, Sunaryo PL, Keeley BR, Kovalerchik O, Mauro AC, Eloy JA. Characterizing liability for cranial nerve injuries: a detailed analysis of 209 malpractice trials. Laryngoscope. 2013;123:1156-1162.

—Reviewed by Amy Eckner

Obesity in Children with OSA can Lead to Depression, Withdrawal

Is there a correlation between obstructive sleep apnea (OSA), obesity, behavior and quality of life in children?

Background: Obesity in children has greatly increased over the last 30 years. Previous studies have not found a linear correlation between obesity degree and OSA severity. In this study, caregivers were asked to complete the OSA quality of life questionnaire (OSA-18) and Behavior Assessment System for Children (BASC-2). All children underwent complete head and neck examinations to include tonsillar size assessments. Children were divided into Groups 1 (OSA-obese), 2 (OSA-normal weight) and 3 (primary snoring-normal weight with sleep-disordered breathing, but no OSA).

Study design: Case-control study of 73 children with pediatric OSA aged 2 to 18 years; the study was conducted between 2006 and 2009. Children with significant comorbidities, and those who were underweight or overweight but not obese, were excluded.

Setting: Cardinal Glennon Children’s Medical Center, St. Louis, Mo.

Synopsis: Mean ages of Groups 1, 2 and 3 were 9.5, 7.2 and 7.5 years, respectively. There were no gender, ethnicity, family income or family education differences between Groups 1 and 2. There were no age, BMI z score, ethnicity, family income or family education differences between Groups 2 and 3. The apnea-hypopnea index (AHI) was significantly higher for Group 1 than Group 2; there were no differences in tonsillar size. Group 1 had a worse mean total OSA-18 score than Group 2, with significant differences in emotional distress and daytime problems. Group 1 also had worse scores than Group 2 on BASC-2 for depression, withdrawal and internalizing problems. Groups 2 and 3 did not differ for any BASC-2 results. There was no correlation between BMI z score and OSA severity as measured by AHI; AHI correlated with OSA-18 scores but not with the behavioral symptoms index (BSI). There was a positive correlation between OSA-18 total scores and BSI. For Groups 1 and 2, AHI correlated with OSA-18 but not BSI; for Group 3, AHI did not correlate with either OSA-18 or BSI, but there was a correlation between OSA-18 and BSI. Limitations included the small size of individual subgroups, polysomnography behavior and quality of life issues, possibly related to poor age matching, lack of a true control population and parental bias.

Bottom line: Obesity appeared to contribute to differences in internalizing behaviors, but not in externalized behaviors; poor correlation between OSA severity, quality of life and behavior underscore the importance of treating OSA regardless of severity.

Citation: Tripuraneni M, Paruthi S, Armbrecht ES, Mitchell RB. Obstructive sleep apnea in children. Laryngoscope. 2013;123:1289-1293.

—Reviewed by Amy Eckner

Many Otolaryngologists Dissatisfied with Current Sinus CT Results

How satisfied are otolaryngologists with paranasal sinus computed tomography (PSCT), and how effective is it?

Background: PSCT is an important aid in the diagnosis of chronic rhinosinusitis because of the excellent osseous detail it provides, including extent and characterization of the disease, location of surgically relevant anatomic structure and critical anatomic variations. Although standardized reporting templates exist for many pathology and radiology investigations, standardized PSCT reporting has failed to gain acceptance among otolaryngology communities.

Study design: A national voluntary online survey of practicing otolaryngologists in Canada (14 percent response rate) and a randomized retrospective review of PSCT reporting from two major centers between December 1, 2009 and December 1, 2011.

Setting: A national survey of all Canadian otolaryngologists was conducted in September 2011; Alberta Health Services—Calgary Zone and the Ottawa Hospital.

Synopsis: Seventy-five percent of all survey respondents indicated that current PSCT reporting did little for clinical assessments, with 67 percent wanting more clinically relevant information on CRS disease staging and sinonasal anatomic variations, as well as information addressing high-risk areas encountered during endoscopic sinus surgery.

PSCT scan results were separated into groups based on radiologist training and experience: head and neck radiologists (at least two years of neuroradiology fellowship training, including detailed head and neck training); neuroradiologists (at least two years of neuroradiology fellowship training, with less than 50 percent of that time spent interpreting non-neuro head and neck imaging studies); and other radiologists (did not fulfill the criteria for either of the other two groups). A list of seven critical and 11 noncritical items were examined in the PSCTs; three independent reviewers reviewed each PSCT report. Reporting of both critical and noncritical items was inconsistent and highly variable, and variation depended on the training and experience of the radiologist. The most consistently reported items were optic nerve anatomy, internal carotid artery anatomy and lamina papyracea integrity. The least consistently reported items were anterior ethmoid artery location, ethmoid skull base integrity and the presence of a sphenoethmoidal (Onodi) cell.

Bottom line: Although important information is inconsistently reported for PSCT, a concise and clinically relevant standardized template may increase reporting quality and consistency.

Citation: Deutschmann MW, Yeung J, Bosch M, et al. Radiologic reporting for paranasal sinus computed tomography: a multi-institutional review of content and consistency. Laryngoscope. 2013;123:1100-1105.

—Reviewed by Amy Eckner