- Email: [email protected]
The Cooperative Outcomes Group for ENT: A multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media
The Cooperative Outcomes Group for ENT: A multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media DAVID L. WITSELL, MD, MHS, MICHAEL G. STEWART, MD, MPH, EDWIN M. MONSELL, MD, PHD, JAMES A. HADLEY, MD, JEFFREY E. TERRELL, MD, BEVAN YUEH, MD, RICHARD M. ROSENFELD, MD, MPH, MAUREEN T. HANNLEY, PHD, and SUSAN SEDORY HOLZER, MA, Durham, North Carolina, Houston, Texas, Southfield and Ann Arbor, Michigan, Seattle, Washington, Brooklyn, New York, and Alexandria, Virginia
OBJECTIVE: Outcomes for patients with otitis media were assessed in this prospective, multicenter study. STUDY DESIGN AND SETTING: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure. RESULTS: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month followup. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling. CONCLUSIONS: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered. SIGNIFICANCE: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis me-
From the Duke University Medical Center, Division of Otolaryngology-Head and Neck Surgery, Durham Veterans Administration Medical Center, Durham, NC (Dr Witsell); Baylor College of Medicine, Department of Otolaryngology, Houston, TX (Dr Stewart); Department of Otolaryngology—Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI and University Otolaryngology, PC, Southfield, MI (Dr Monsell); University of Rochester (Dr Hadley); University of Michigan Medical Center, Ann Arbor, MI (Dr Terrell); and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Alexandria, VA (Dr Hannley and Ms Holzer); VA Puget Sound Health Care System, Department of Otolaryngology–Head and Neck Surgery, University of Washington, Seattle, WA (Dr Yueh); Department of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, NY (Dr Rosenfeld). Reprint requests: David L. Witsell, MD, MHS, Box 3805, Division of Otolaryngology, Duke University Medical Center, Durham, NC 27710; e-mail, [email protected]. 0194-5998/$30.00 Copyright © 2005 by the American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. doi:10.1016/j.otohns.2004.11.004
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dia into surgical versus medical interventions. EBM rating: C. (Otolaryngol Head Neck Surg 2005;132:180-8.)
T
he majority (83%–90%) of healthy children in the United States are treated for acute otitis media (AOM) before the age of 7 years. In most of these children (70%–90%), an episode of AOM resolves within 7 to 14 days with or without antibiotic therapy. Middle ear fluid typically resolves within 3 months in 80%–90% of cases.1,2 Because of the prevalence of otitis media (OM; 9.3 cases of AOM annually), 1.9 million children experience middle ear effusions for longer than 6 weeks. Herein lies the concern regarding cost of treating OM (⬃4 billion dollars annually), and heated debate regarding the long-term effects of auditory deprivation during critical language and speech developmental windows.2-8 A single episode of OM can be an inconvenience for both the child and family, but when multiple or unresolved episodes of OM lead to chronic ear disease in the child, developmental, patient, and family QOL become important outcomes to measure in assessing provider and intervention effectiveness. Health-related quality of life (HRQOL) outcomes for OM include several psychosocial dimensions that have been studied and validated.4 The Otitis Media 6 (OM-6) is a disease-specific QOL instrument for chronic and recurrent otitis media that explores the psychosocial domains of physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns that are associated with ear infections. The survey has been validated and is reliable, valid, and responsive to clinical change.4The instrument is completed by the caretaker or parent. Because parents of children with OM drive health care utilization, their interpretation and understanding of how well their child responds to treatment is an important outcome linked not only to health care costs and clinical change but also to patient and caregiver satisfaction and perception of the child’s wellness.
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The Cooperative Outcomes Group for ENT (COG*ENT) was established by the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) to document outcomes of both OM and chronic rhinosinusitis. By using a prospective multicenter observational design, COG*ENT explored psychosocial outcomes measured by the OM-6 for children seen and treated by an otolaryngologist. The study design did not direct treatment decisions by the participating physicians but rather assessed patient outcomes prospectively. The COG*ENT task force on OM designed the protocol, selected a disease-specific outcomes survey, and developed the clinical and demographic data forms. The COG*ENT OM database was then examined for changes in disease-specific QOL and associations of clinical and demographic variables with disease-specific outcomes. Additionally, we explored the response characteristics of the OM-6 in this diverse group of patients. MATERIALS AND METHODS Subjects A convenience sample of children with a history and clinical presentation of OM were enrolled by participating otolaryngologists. A patient was considered a candidate to participate in COG*ENT if he or she had a documented history of ear problems and was referred for management of ear problems. The inclusion criterion for the study was that the child (0 –16 years old) had a primary diagnosis of OM (acute, chronic, serous, or mucoid and/or eustachian tube dysfunction) by the otolaryngologist. Patients seen for other nose and throat problems as a primary diagnosis were excluded from enrollment in the COG*ENT OM study. Measures All patients underwent an otoscopic examination, including pneumatic otoscopy by the physician when indicated, and status of the middle ear was recorded. Data from audiometric testing or tympanometry were recorded when available. The treating physician was asked to record all the related diagnoses and the recommended treatment. Treatment was classified as medical, surgical, or both, and the physician was asked to indicate what specific treatment was recommended for each intervention modality (ie, tympanostomy tube insertion, antibiotics, etc.). Clinical data were recorded at each follow-up visit. Caregivers completed a questionnaire at baseline and at each follow-up interval. The questionnaire included the Otitis Media 6 (OM-6) survey4 and a question assessing perception of global QOL due to OM on a scale of 0 –10, with 0 being the worst QOL. The
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OM-6 score was the primary outcome measure, and the OM QOL score was a secondary outcome measure. The caregiver questionnaire also included items regarding the number of ear infections and percent of time spent with ear infections over a given time period, child-and caregiver-missed days of school or work, OM symptom ratings, and caregiver concern regarding child’s health. Study Sites Members of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) volunteered as site investigators for this study. Site investigators agreed to abide by the clinical research standards established by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) and the Duke University Institutional Review Board. The Duke Institutional Review Board approved the research plan. The distribution of the sites is shown in Fig 1. Project Coordination and Case Report Forms The Duke Clinical Research Institute collaborated with the AAO-HNSF to manage the research activities of COG*ENT. Full detail in project coordination is reported in the COG*ENT Chronic Rhinosinusitis study.1 The case report forms (CRFs) were color coded to facilitate easy identification and were sent to the sites in a ringed binder with all forms necessary for enrollment and follow-up of patients. A preprinted study ID number that corresponded to a specific physician site ID linked all forms. Tracking reports were sent out by the coordinating center every 2 weeks. Data Analysis The OM-6 score was calculated according to Rosenfeld,4 with a score of 7.0 indicating the worst symptoms possible and a score of 1.0 indicating no problems at all. A positive OM-6 change score indicates a reduction in symptoms. Change scores of less than 0.5 indicate no or trivial change, 0.50 – 0.99 indicate small change, 1.0 –1.49 indicate moderate change, and change scores of 1.50 or more indicate large change. The patient’s OM QOL score was assessed on a scale from 10 (best QOL) to 0 (worst QOL). A drop in the OM QOL score reflects improvement. The changes in OM-6 and OM QOL scores were assessed statistically by using the Wilcoxon Signed Rank test. Because we wanted to determine whether the OM-6 performed similarly in our group of patients to the group for which the OM-6 was originally characterized, we examined construct validity (correlation of OM-6
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Fig 1. Sites participating in the COG*ENT OM module.
score change to change in OM QOL score) and sensitivity to change by using standardized response means (defined as the mean change score divided by its SD). In general, a standardized response mean of 0.2 or less represents small responsiveness; one of 0.5, moderate responsiveness; and one of 0.8 or greater, large responsiveness to change. The advisory committee defined clinical success for the COG*ENT study as an OM-6 change score of 1 point or greater (see Rosenfeld4). A 1-point change corresponds to a moderate clinical change in diseasespecific QOL. Logistic regression was performed to examine which baseline variables were associated with clinical success at 3 months. Because COG*ENT was initially conceived of as a database repository rather than as a hypothesis-driven research study, our report is based upon a post hoc analysis of those data. The sample size and power of our study were not determined.
RESULTS Subjects Thirty-one physicians (30 private practice and 1 academic) participated in the OM module of COG*ENT. The average number of patients recruited per site between August 2000 and June 2002 was 9 patients, with a range of 1 to 26. Twenty-five, 20, and 12 sites contributed to follow-up data at 3, 6, and 12 months’ follow-up respectively. A total of 272 patients were enrolled in the OM module during the study period, but only 263 physician baseline forms and 253 patient baseline forms were completed and were included in the respective data analyses. Of these patients, 177, 140, and 72 provided follow-up data at 3, 6 and 12 months after enrollment. Because follow-up data were obtained principally by mail and were not dependent upon an office visit, matching clinical data provided by the physician
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Fig 2. Population flowchart for OM module. Data in rectangles are n values. Medical management ⫽ patients who were prescribed medication at a physician assessment or who indicated that they had taken antibiotics before follow-up. Because medication was repeatedly administered, the first prescribed date or follow-up visit date was used as the start of medical management. PET performed after baseline ⫽ patients who had a patient assessment follow-up form indicating that they had received tubes since the past visit were also added to this population.
were nearly always available for the enrollment or baseline visit (n ⫽ 263) but less so for follow-up visits (89, 82, and 49 clinical forms at 3, 6, and 12 months, respectively; see Fig 2). There were no statistically significant differences in the demographic and clinical variables for those patients with and without corresponding clinical information at 3 and 6 months in the primary outcome measure. The mean age of the study population (n ⫽ 253) was 2.0 years (⫾2.4). The majority of the children
were Caucasian (81%), and boys constituted 62.4% of the population. Most patients (76.2%) were new to the otolaryngology practice. Caregivers listed speech problems (13.0%), allergies (8.3%), and hearing problems (7.1%) as the most frequent previous diagnoses. The mean age of the child’s caregiver was 31.1 years (⫾5.3); most were female (92.5%), working full-or part-time (72.6%), and had at least attended college (74.6%). There was a smoker in the household in 18.9% of the study population.
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Table 1. Clinical features of patients based on physician evaluation forms from baseline visit
Variable Diagnoses* Otitis media Acute nonsuppurtative or chronic serous/ mucoid Other† Conductive hearing loss Mixed hearing loss Obstructive sleep apnea Physician current exam‡ Normal Acute OM Uninfected middle ear effusion Dry tube Ear drum retraction
All patients, n (%)
PET patients, n (%)
197 (74.9)
105 (76.6)
109 (41.4) 25 (9.5) 1 (0.4) 7 (2.7)
65 (47.4) 13 (9.5)
25 (9.5) 32 (12.2) 119 (45.2)
0 24 (17.5) 68 (49.6)
3 (1.1) 28 (10.6)
0 16 (11.7)
3 (2.2)
n ⫽263 for all patients; n ⫽ 137 for patients who underwent myringotomy and tube placement [PET group]). *Patients may have more than 1 diagnosis. †Includes the diagnoses Other chronic nonsuppurative otitis, Acute infection, Chronic infection, Unspecified infection, Unspecified OM, and Enlarged adenoids. ‡Patients with unilateral ear disease are not included in this table.
Most caregivers (88.1%) reported that their child experienced his or her first ear infection before their first birthday. More than half (59.4%) of the caregivers had been given 3 or more antibiotic prescriptions in the past 3 months for their child’s OM. A small percentage of the children (15.2%) previously had tympanostomy tube placement, on average more than a year before this visit. Physician evaluation results at baseline are shown in Table 1. Nearly three quarters (74.9%; n ⫽ 197) of the patients were diagnosed with acute or chronic serous OM at presentation. Physical examination indicated that the majority of the enrolled cohort (45.2%, n ⫽ 119) had bilateral uninfected middle ear effusion. Hearing loss was reported by the physician to be “documented by audiometry or clinically suspected” in 148 children (61.4%). Tympanometry was recorded as type B bilaterally in 60% of the cases. Physicians recorded myringotomy with tube insertion more frequently than any other treatment option (Table 2). OM Outcomes At each evaluation interval, caregivers recorded the number of ear infections and the approximate percentage of time that the child suffered from ear effusions for the prior 1-month period. Table 3 summarizes these data.
Table 2. Treatment recommendations* based on physician evaluation forms from baseline visit
Variable Surgical Myringotomy (no tube) Laser myringotomy Myringotomy with tube Middle ear exploration Tympanoplasty Mastoidectomy Adenoidectomy Other: Medical management Antibiotics or other meds
All patients, n (%)
PET patients, n (%)
6 ( 2.3) 1 ( 0.4) 190 (72.2) 1 (0.4) 1 (0.4) 1 (0.4) 33 (12.5) 26 (9.9)
2 (1.5) 1 (0.7) 115 (83.9) 0 0 0 16 (11.7) 10 (7.3)
79 (30.0)
42 (30.7)
n ⫽ 263 for all patients; n ⫽ 137 for patients who underwent myringotomy and tube placement [PET group]). *Patients may have more than 1 recommendation or no recommendation recorded on the physician form and be noted to have PET placement on the follow-up visit.
At baseline, only 23.6% of the children were noted to have had no ear infections during the prior month. At the 3-month follow-up, the number of children reported to be infection free during the prior month increased to 81.0%, and this figure remained similar at later follow-up intervals. Similarly, the percentage of parents who reported that the approximate percentage of time that children had middle ear effusions was ⬎50% of the prior month dropped from 47.9% at baseline to less than 5% of parents at follow-up. OM-6 and OM QOL Results The average OM-6 score for all patients at enrollment was 3.02 ⫾ 1.1. The mean decrease for all patients (change score) was 1.17 ⫾ .13 at 3 months (P ⬍ 0.0001). In patients who had tympanostomy tube placement (PET), the average baseline OM-6 score was 3.14 ⫾ 1.1, and the mean OM-6 3-month change score was 1.65 (1.40 –1.89; 95% confidence interval [CI]; P ⬍ 0.0001). This improvement was sustained and significant at 6 and 9 months after surgery (P ⬍ 0.0001; Table 4). Parents were asked to rate the child’s overall QOL due to ear infections in the past 1 month (OM QOL) at 3, 6, and 12 months’ follow-up. On a scale of 1 to 10, a mean decrease (improvement) of –2.8 (P ⬍ 0.0001) was obtained at the 3-month follow-up for the children undergoing PET and was consistent for the later follow-up intervals. These results are shown in Table 5. Validation of the OM-6 The sensitivity (SRM) of the OM-6 in our group of patients was 1.2, indicating very high sensitivity to
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Table 3. Number of ear infections and percentage of time child spent with ear effusions during the past month for all children followed in COG*ENT Variable
Baseline (n ⴝ 253)
3 mo (n ⴝ 177)
6 mo (n ⴝ 140)
12 mo (n ⴝ 72)
41 23.6 74.1 2.4 0.0 0.0
9 81.0 19.0 0.0 0.0 0.0
6 73.9 26.1 0.0 0.0 0.0
3 81.2 18.8 0.0 0.0 0.0
38 33.0 19.1 14.9 33.0
7 90.0 5.3 0.6 4.1
9 85.5 8.4 3.8 2.3
2 87.1 10.0 0.0 2.9
No. of ear infections Missing (n) 0 (%) 1–3 (%) 4–6 (%) 7–9 (%) ⱖ10 (%) Percentage of time child spent with ear effusions Missing (n) 0–25 (%) 26–50 (%) 51–75 (%) 76–100 (%)
Table 4. Mean OM-6 scores at baseline and follow-up and mean change (baseline–follow-up)* for all children and those undergoing tympanostomy tube placement after baseline Follow-up (mo) All patients 3 Tympanostomy tube patients 3 6 ⱖ9
n
OM-6 baseline
OM-6 follow-up
Change score
95% CIs
155
3.0
1.8
1.2
1.0 to 1.3
100 75 30
3.1 3.1 3.2
1.4 1.5 1.6
1.7 1.5 1.6
1.3 to 1.9 1.2 to 1.8 1.1 to 2.2
Patients with follow-up but who did not complete the OM-6 are not included in this analysis. For follow-up versus baseline, all P values ⬍0.0001 (Wilcoxon signed rank test). *A positive value denotes improvement.
Table 5. Mean OM QOL scores at baseline and follow-up and mean change (baseline–follow-up)* for children undergoing tympanostomy tube placement after baseline Follow-up (mo)
n
QOL baseline
QOL follow-up
Change score
95% CIs
3 6 ⱖ9
90 69 28
6.4 6.7 6.5
9.1 9.0 9.3
⫺2.7 ⫺2.4 ⫺2.8
⫺3.2 to ⫺2.3 ⫺2.8 to ⫺1.9 ⫺3.6 to ⫺2.0
For follow-up versus baseline, all P values ⬍ 0.0001 (Wilcoxon signed rank test). *A negative value denotes improvement.
change. Good correlation (construct validity) between the OM-6 and the OM QOL was noted in our study group (r ⫽ – 0.50; P ⬍ 0.001). Lower (poorer) QOL scores at baseline are associated with higher (poorer) OM-6 scores at baseline. Our results regarding sensitivity and validity are similar to the results reported by Rosenfeld.4
Regression Analysis for Tympanostomy Tubes Univariate regression analysis was performed of children who underwent PET insertion. Table 6 shows the results of that analysis. In patients with OM who have PETs inserted, associations between clinical suc-
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Table 6. Predictors of clinical success in children with OM undergoing tympanostomy tube placement Predictor
P value
Chi-square
Odds ratio
95% CI for odds ratio
Born prematurely No. of diagnoses No. of children in daycare Other children at home under age 7 y
0.944 0.540 0.546 0.073
.005 .376 .365 3.222
.955 1.299 1.133 .460
.258–3.525 .561–3.012 .755–1.699 .195–1.084
No. of ear infections in past 3 mo
0.074
3.189
1.891
.913–3.917
Percentage of ear infections in past 3 months
0.002
9.441
1.940
1.243–3.029
Caregiver educational level
0.012
6.286
1.720
1.110–2.665
New patient to practice Child heath compared with 1 y ago Parent age Parent work status
0.544 0.194 0.343 0.004
.368 1.690 .899 8.228
1.391 1.394 1.044 2.883
.473–4.092 .837–2.322 .955–1.140 1.259–6.602
Suspected hearing loss Quality of life
0.485 0.0001
.487 14.776
1.423 .611
.530–3.821 .457–.817
Daycare Smoke at home Child age Gender Ethnic group Comorbidities
0.252 0.732 0.607 0.669 0.214 0.863
1.312 .117 .264 .183 1.542 .030
1.714 .827 1.055 .832 2.077 .906
.684–4.297 .277–2.468 .845–1.317 .358–1.932 .659–6.542 .295–2.78
Direction of effect
Negative. Other children at home associated with lower chance of success. Positive. More infections associated with better chance of success. Positive. Greater percentage of time with infection associated with better chance of success. Positive. Higher education level associated with better chance of success.
Positive. Working parents associated with better chance of success. Negative. Lower QOL score associated with better chance of success.
Predictors in bold typeface were noted to be significant in the univariate regression.
cess and the baseline OM-6 score, number of ear infections, and OM QOL score were found. Logistic modeling for predicting clinical success includes both the baseline OM-6 score (P ⬍ 0.0001; odds ratio ⫽ 10.42; 95% CI ⫽ 4.32–25.14) and caregiver years of schooling. Other clinical factors, such as presence in daycare, demographic factors, as well as comorbid illnesses, did not improve the model for predicting clinical success. The effect of medical treatment versus PET insertion was not compared because of the small number of children in the medically treated group (n ⫽ 15). DISCUSSION COG*ENT was established by the AAO-HNSF. In the OM module, COG*ENT prospectively collected data on patient-oriented outcomes after treatment by an otolaryngologist. Children were enrolled from multiple practice sites across the United States. Overall, children in our study improved significantly and reported fewer
ear infections at follow-up intervals. These data show that both the general and disease-specific QOL was better—substantially so—3 months after being evaluated and treated by an otolaryngologist. We cannot specifically quantify how much of this improvement was caused by physician management versus the natural history of OM. However, this observational study design shows that the improvement was recorded from the time of first visit to the otolaryngologist. Our study also shows that medical treatment with PET insertion was followed by improved disease-specific QOL for up to 9 months in some patients. This finding is consistent with findings of other authors who have measured good outcomes with tympanostomy tube insertion.9,10 The disease-specific domains of the OM-6 in which caregivers report large disease-specific improvements in QOL are physical suffering, emotional distress, and caregiver concerns. These 3 dimensions were also noted to be the most sensitive to change in the development of the OM-6.4
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The OM-6 survey appeared to be both valid and sensitive in our diverse study group, making it a good measurement for reporting OM outcomes in the community setting with diverse pediatric patient groups. The 3-month OM-6 mean change score was greater in the subset of children receiving PETs compared with in the entire group of children enrolled. This is likely due to the higher baseline OM-6 score (more burden of disease) that improves after the intervention. Unfortunately, we were not able to compare different treatment outcomes (medical vs. surgical) because of lack of sufficient numbers of patients in a medically treated group. Regression analysis was performed only on patients receiving PET insertion. Univariate regression analysis revealed several variables that were associated with clinical success after treatment of OM with tympanostomy tubes. These included infection severity (measured as number of infections and percentage of time with an infection), overall QOL impact of disease at presentation, caregiver educational level, employment of the parent, and baseline OM-6 score. These findings fall into 2 general categories: the first is measures of disease burden, and the second category is measures associated with socioeconomic status. When all of these variables are used in logistic analysis, only baseline OM-6 score and caregiver educational level remain significant. Further, modeling reveals that nearly all the variability in outcome can be explained by the baseline OM-6 score alone. Factors that other studies have shown to be associated with risk for recurrent OM or serous OM, such as use of day care, smoking at home, or presence of comorbid disease, were not significant in our study.2,11 Our regression analysis was different in that we examined children who already had indications for PET insertion due to OM rather than exploring which risk factors are associated with recurrent OM. Although these risk factors may have been present and significant in our group of patients in the development of the ear disease before PET insertion, these variables did not appear to be associated with clinical success after PET insertion. The finding of poorer QOL at presentation predicting larger improvement in QOL is not surprising and has been found in other studies, as long as the treatment is effective. Patients with poorer QOL have potentially more “room” for improvement and perhaps return closer to a disease-free baseline after successful treatment. Therefore, when attempting to predict improvement after treatment, measuring impact at baseline is very important. Strengths of this study include its prospective design, multicenter patient enrollment, and length of fol-
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low-up. These data represent a cross-section of otolaryngology practices and patients in the United States, rather than a single practice that might be focused on a particular study, treatment approach, or disease. The study design allowed for each physician to make treatment decisions as he or she would normally practice. Other prospective studies on outcomes after treatment of OM have found similarly favorable results. Large improvements in global, as well as disease-specific, QOL have been documented by several authors using validated OM questionnaires.12-14 Additionally, a meta-analysis of randomized clinical trials examining the efficacy of tympanostomy tubes in children has shown decreased time with middle ear effusion, reduction of the incidence of AOM, and short-term improvement in disease-specific QOL. The maximum benefit was seen from 6 to 12 months of follow-up, which is also seen in our multicenter prospective outcomes study.15 Our lack of tight controls on patient inclusion and exclusion criteria and treatment allocation would tend to increase outcome variability and dampen the effect in disease-specific QOL. The fact is intriguing that after otolaryngology management, the improvement was substantial (“large” by OM-6 criteria). Further study is required to understand how the different role and management strategies used by otolaryngologists impact the magnitude of their patients’ respective outcomes. Determining which treatment resulted in the greatest improvement in QOL was beyond the scope of this study and not part of its specific aims. Further, because the study was not controlled and used a convenience sample, we cannot determine whether the improvements that we saw were going to occur irrespective of whether or not the patient saw an otolaryngologist. The sampling strategy also does not allow us to describe the daily triage of the patients into a surgical or medical treatment regimen that occurs in usual practice. Our study was observational and did not randomly allocate treatment, whether medical, surgical, or watchful waiting, and this represents a limitation of the study for determining causality or efficacy of a specific treatment regimen. However, this report documents our earliest efforts in successfully organizing multicenter outcome studies. We acknowledge that the study serves more as a lesson learned and not as perfect science, but it lays the foundation for the Academy’s future plans to engage community practitioners from diverse practice settings and to facilitate their participation in future evidence-based medicine studies. The authors acknowledge the site investigators who contributed their time and effort in this study: Michael Widick, MD; Joseph Leonard, MD; Myron Yencha Jr, MD; Steven
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Peskind, MD; Donald Lewis, MD; Samuel Meadema, MD; Jerry Schreibstein, MD; Richard Waguespack, MD; Dennis Diaz, MD; James Hadley, MD; Rebecca Gaughan, MD; Arthur Hengerer, MD; Paul Loeffler, MD; Daniel Spilman, MD; C. Ron Cannon, MD; Jonathan Levine, MD; Chung-En Huang; Jean-Jacques Rafie, MD; Barry Jacobs, MD; Stephen Kupferberg, MD; Diana Tobon, MD; Dwight Ellerbe, MD; J. David Cunningham, MD; John Laurenzo, MD; Michael Dias, MD; J. Pablo Stolovitzky, MD; Scott Schaffer, MD, Reginald Rice, MD, Phillip Noel, MD; Lance Meyerson, MD. Additionally, the authors acknowledge the OM Task Force: Kenneth M. Grundfast, MD; Chair Margaretha Casselbrant, MD; George A. Gates, MD; Carol R. Gerson, MD; David R. Nielsen, MD; Seth M. Pransky, MD; Richard M. Rosenfeld, MD. REFERENCES 1. Rosenfeld RM. An evidence based approach to treating otitis media. Pediatr Clin North Am 1996;43:1165-81. 2. Klein JO, Teele DW, Pelton SI. New concepts in otitis media: results of investigations of the Greater Boston Otitis Media Study Group. Adv Pediatr 1992;39:127-56. 3. Gates GA. Cost-effective considerations in otitis media treatment. Otolaryngol Head Neck Surg 1996;114:525-30. 4. Rosenfeld RM, Goldsmith AJ, Tetlus L, et al. Quality of life for children with otitis media. Arch Otolaryngol Head Neck Surg 1997;123:1049-54.
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5. Pillsbury HC, Grose JH, Hall JW. Otitis media with effusion in children. Binaural hearing before and after surgery. Otolaryngol Head Neck Surg 1991;117:718-23. 6. Hall JW 3rd, Grose JH, Pillsbury HC. Long-term effects of chronic otitis media on binaural hearing in children. Arch Otolaryngol Head Neck Surg 1995;121:847-52. 7. Schilder AG, Van Maren JG, Zielhuis GA, et al. Long-term effects of otitis media with effusion on language, reading and spelling. Clin Otolaryngol Allied Sci 1993;18:234-41. 8. Roberts K. A preliminary account of the effect of otitis media on 15 month-olds’ categorization and some implications for early language learning. J Speech Lang Hear Res 1997;40:508-18. 9. Hathaway TJ, Katz HP, Dershewitz RA, et al. Acute otitis media: who needs posttreatment follow-up? Pediatrics 1994;94:143-7. 10. Marais J, Armstrong MW. Parental knowledge and experiences after surgery for chronic otitis media. Br J Clin Pract 1996;50: 187-9. 11. Pelton SI. New concepts in the pathophysiology and management of middle ear disease in childhood. Drugs 1996;52(suppl 2):62-6, discussion 66-7. 12. Richards M, Giannoni C. Quality-of-life outcomes after surgical intervention for otitis media. Arch Otolaryngol Head Neck Surg 2002;128:776-82 13. Rosenfeld RM, Bhaya MH, Bower CM, et al. Impact of tympanostomy tubes on child quality of life. Arch Otolaryngol Head Neck Surg 2000;126:585-92. 14. Rovers MM, Krabbe PF, Straatman H, et al. Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years. Arch Dis Child 2001;84:45-59. 15. Rosenfeld RM. Surgical prevention of otitis media. Vaccine 2001;19:S134-9.
OBJECTIVE: Outcomes for patients with otitis media were assessed in this prospective, multicenter study. STUDY DESIGN AND SETTING: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure. RESULTS: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month followup. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling. CONCLUSIONS: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered. SIGNIFICANCE: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis me-
From the Duke University Medical Center, Division of Otolaryngology-Head and Neck Surgery, Durham Veterans Administration Medical Center, Durham, NC (Dr Witsell); Baylor College of Medicine, Department of Otolaryngology, Houston, TX (Dr Stewart); Department of Otolaryngology—Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI and University Otolaryngology, PC, Southfield, MI (Dr Monsell); University of Rochester (Dr Hadley); University of Michigan Medical Center, Ann Arbor, MI (Dr Terrell); and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Alexandria, VA (Dr Hannley and Ms Holzer); VA Puget Sound Health Care System, Department of Otolaryngology–Head and Neck Surgery, University of Washington, Seattle, WA (Dr Yueh); Department of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, NY (Dr Rosenfeld). Reprint requests: David L. Witsell, MD, MHS, Box 3805, Division of Otolaryngology, Duke University Medical Center, Durham, NC 27710; e-mail, [email protected]. 0194-5998/$30.00 Copyright © 2005 by the American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. doi:10.1016/j.otohns.2004.11.004
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dia into surgical versus medical interventions. EBM rating: C. (Otolaryngol Head Neck Surg 2005;132:180-8.)
T
he majority (83%–90%) of healthy children in the United States are treated for acute otitis media (AOM) before the age of 7 years. In most of these children (70%–90%), an episode of AOM resolves within 7 to 14 days with or without antibiotic therapy. Middle ear fluid typically resolves within 3 months in 80%–90% of cases.1,2 Because of the prevalence of otitis media (OM; 9.3 cases of AOM annually), 1.9 million children experience middle ear effusions for longer than 6 weeks. Herein lies the concern regarding cost of treating OM (⬃4 billion dollars annually), and heated debate regarding the long-term effects of auditory deprivation during critical language and speech developmental windows.2-8 A single episode of OM can be an inconvenience for both the child and family, but when multiple or unresolved episodes of OM lead to chronic ear disease in the child, developmental, patient, and family QOL become important outcomes to measure in assessing provider and intervention effectiveness. Health-related quality of life (HRQOL) outcomes for OM include several psychosocial dimensions that have been studied and validated.4 The Otitis Media 6 (OM-6) is a disease-specific QOL instrument for chronic and recurrent otitis media that explores the psychosocial domains of physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns that are associated with ear infections. The survey has been validated and is reliable, valid, and responsive to clinical change.4The instrument is completed by the caretaker or parent. Because parents of children with OM drive health care utilization, their interpretation and understanding of how well their child responds to treatment is an important outcome linked not only to health care costs and clinical change but also to patient and caregiver satisfaction and perception of the child’s wellness.
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The Cooperative Outcomes Group for ENT (COG*ENT) was established by the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) to document outcomes of both OM and chronic rhinosinusitis. By using a prospective multicenter observational design, COG*ENT explored psychosocial outcomes measured by the OM-6 for children seen and treated by an otolaryngologist. The study design did not direct treatment decisions by the participating physicians but rather assessed patient outcomes prospectively. The COG*ENT task force on OM designed the protocol, selected a disease-specific outcomes survey, and developed the clinical and demographic data forms. The COG*ENT OM database was then examined for changes in disease-specific QOL and associations of clinical and demographic variables with disease-specific outcomes. Additionally, we explored the response characteristics of the OM-6 in this diverse group of patients. MATERIALS AND METHODS Subjects A convenience sample of children with a history and clinical presentation of OM were enrolled by participating otolaryngologists. A patient was considered a candidate to participate in COG*ENT if he or she had a documented history of ear problems and was referred for management of ear problems. The inclusion criterion for the study was that the child (0 –16 years old) had a primary diagnosis of OM (acute, chronic, serous, or mucoid and/or eustachian tube dysfunction) by the otolaryngologist. Patients seen for other nose and throat problems as a primary diagnosis were excluded from enrollment in the COG*ENT OM study. Measures All patients underwent an otoscopic examination, including pneumatic otoscopy by the physician when indicated, and status of the middle ear was recorded. Data from audiometric testing or tympanometry were recorded when available. The treating physician was asked to record all the related diagnoses and the recommended treatment. Treatment was classified as medical, surgical, or both, and the physician was asked to indicate what specific treatment was recommended for each intervention modality (ie, tympanostomy tube insertion, antibiotics, etc.). Clinical data were recorded at each follow-up visit. Caregivers completed a questionnaire at baseline and at each follow-up interval. The questionnaire included the Otitis Media 6 (OM-6) survey4 and a question assessing perception of global QOL due to OM on a scale of 0 –10, with 0 being the worst QOL. The
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OM-6 score was the primary outcome measure, and the OM QOL score was a secondary outcome measure. The caregiver questionnaire also included items regarding the number of ear infections and percent of time spent with ear infections over a given time period, child-and caregiver-missed days of school or work, OM symptom ratings, and caregiver concern regarding child’s health. Study Sites Members of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) volunteered as site investigators for this study. Site investigators agreed to abide by the clinical research standards established by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) and the Duke University Institutional Review Board. The Duke Institutional Review Board approved the research plan. The distribution of the sites is shown in Fig 1. Project Coordination and Case Report Forms The Duke Clinical Research Institute collaborated with the AAO-HNSF to manage the research activities of COG*ENT. Full detail in project coordination is reported in the COG*ENT Chronic Rhinosinusitis study.1 The case report forms (CRFs) were color coded to facilitate easy identification and were sent to the sites in a ringed binder with all forms necessary for enrollment and follow-up of patients. A preprinted study ID number that corresponded to a specific physician site ID linked all forms. Tracking reports were sent out by the coordinating center every 2 weeks. Data Analysis The OM-6 score was calculated according to Rosenfeld,4 with a score of 7.0 indicating the worst symptoms possible and a score of 1.0 indicating no problems at all. A positive OM-6 change score indicates a reduction in symptoms. Change scores of less than 0.5 indicate no or trivial change, 0.50 – 0.99 indicate small change, 1.0 –1.49 indicate moderate change, and change scores of 1.50 or more indicate large change. The patient’s OM QOL score was assessed on a scale from 10 (best QOL) to 0 (worst QOL). A drop in the OM QOL score reflects improvement. The changes in OM-6 and OM QOL scores were assessed statistically by using the Wilcoxon Signed Rank test. Because we wanted to determine whether the OM-6 performed similarly in our group of patients to the group for which the OM-6 was originally characterized, we examined construct validity (correlation of OM-6
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Fig 1. Sites participating in the COG*ENT OM module.
score change to change in OM QOL score) and sensitivity to change by using standardized response means (defined as the mean change score divided by its SD). In general, a standardized response mean of 0.2 or less represents small responsiveness; one of 0.5, moderate responsiveness; and one of 0.8 or greater, large responsiveness to change. The advisory committee defined clinical success for the COG*ENT study as an OM-6 change score of 1 point or greater (see Rosenfeld4). A 1-point change corresponds to a moderate clinical change in diseasespecific QOL. Logistic regression was performed to examine which baseline variables were associated with clinical success at 3 months. Because COG*ENT was initially conceived of as a database repository rather than as a hypothesis-driven research study, our report is based upon a post hoc analysis of those data. The sample size and power of our study were not determined.
RESULTS Subjects Thirty-one physicians (30 private practice and 1 academic) participated in the OM module of COG*ENT. The average number of patients recruited per site between August 2000 and June 2002 was 9 patients, with a range of 1 to 26. Twenty-five, 20, and 12 sites contributed to follow-up data at 3, 6, and 12 months’ follow-up respectively. A total of 272 patients were enrolled in the OM module during the study period, but only 263 physician baseline forms and 253 patient baseline forms were completed and were included in the respective data analyses. Of these patients, 177, 140, and 72 provided follow-up data at 3, 6 and 12 months after enrollment. Because follow-up data were obtained principally by mail and were not dependent upon an office visit, matching clinical data provided by the physician
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Fig 2. Population flowchart for OM module. Data in rectangles are n values. Medical management ⫽ patients who were prescribed medication at a physician assessment or who indicated that they had taken antibiotics before follow-up. Because medication was repeatedly administered, the first prescribed date or follow-up visit date was used as the start of medical management. PET performed after baseline ⫽ patients who had a patient assessment follow-up form indicating that they had received tubes since the past visit were also added to this population.
were nearly always available for the enrollment or baseline visit (n ⫽ 263) but less so for follow-up visits (89, 82, and 49 clinical forms at 3, 6, and 12 months, respectively; see Fig 2). There were no statistically significant differences in the demographic and clinical variables for those patients with and without corresponding clinical information at 3 and 6 months in the primary outcome measure. The mean age of the study population (n ⫽ 253) was 2.0 years (⫾2.4). The majority of the children
were Caucasian (81%), and boys constituted 62.4% of the population. Most patients (76.2%) were new to the otolaryngology practice. Caregivers listed speech problems (13.0%), allergies (8.3%), and hearing problems (7.1%) as the most frequent previous diagnoses. The mean age of the child’s caregiver was 31.1 years (⫾5.3); most were female (92.5%), working full-or part-time (72.6%), and had at least attended college (74.6%). There was a smoker in the household in 18.9% of the study population.
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Table 1. Clinical features of patients based on physician evaluation forms from baseline visit
Variable Diagnoses* Otitis media Acute nonsuppurtative or chronic serous/ mucoid Other† Conductive hearing loss Mixed hearing loss Obstructive sleep apnea Physician current exam‡ Normal Acute OM Uninfected middle ear effusion Dry tube Ear drum retraction
All patients, n (%)
PET patients, n (%)
197 (74.9)
105 (76.6)
109 (41.4) 25 (9.5) 1 (0.4) 7 (2.7)
65 (47.4) 13 (9.5)
25 (9.5) 32 (12.2) 119 (45.2)
0 24 (17.5) 68 (49.6)
3 (1.1) 28 (10.6)
0 16 (11.7)
3 (2.2)
n ⫽263 for all patients; n ⫽ 137 for patients who underwent myringotomy and tube placement [PET group]). *Patients may have more than 1 diagnosis. †Includes the diagnoses Other chronic nonsuppurative otitis, Acute infection, Chronic infection, Unspecified infection, Unspecified OM, and Enlarged adenoids. ‡Patients with unilateral ear disease are not included in this table.
Most caregivers (88.1%) reported that their child experienced his or her first ear infection before their first birthday. More than half (59.4%) of the caregivers had been given 3 or more antibiotic prescriptions in the past 3 months for their child’s OM. A small percentage of the children (15.2%) previously had tympanostomy tube placement, on average more than a year before this visit. Physician evaluation results at baseline are shown in Table 1. Nearly three quarters (74.9%; n ⫽ 197) of the patients were diagnosed with acute or chronic serous OM at presentation. Physical examination indicated that the majority of the enrolled cohort (45.2%, n ⫽ 119) had bilateral uninfected middle ear effusion. Hearing loss was reported by the physician to be “documented by audiometry or clinically suspected” in 148 children (61.4%). Tympanometry was recorded as type B bilaterally in 60% of the cases. Physicians recorded myringotomy with tube insertion more frequently than any other treatment option (Table 2). OM Outcomes At each evaluation interval, caregivers recorded the number of ear infections and the approximate percentage of time that the child suffered from ear effusions for the prior 1-month period. Table 3 summarizes these data.
Table 2. Treatment recommendations* based on physician evaluation forms from baseline visit
Variable Surgical Myringotomy (no tube) Laser myringotomy Myringotomy with tube Middle ear exploration Tympanoplasty Mastoidectomy Adenoidectomy Other: Medical management Antibiotics or other meds
All patients, n (%)
PET patients, n (%)
6 ( 2.3) 1 ( 0.4) 190 (72.2) 1 (0.4) 1 (0.4) 1 (0.4) 33 (12.5) 26 (9.9)
2 (1.5) 1 (0.7) 115 (83.9) 0 0 0 16 (11.7) 10 (7.3)
79 (30.0)
42 (30.7)
n ⫽ 263 for all patients; n ⫽ 137 for patients who underwent myringotomy and tube placement [PET group]). *Patients may have more than 1 recommendation or no recommendation recorded on the physician form and be noted to have PET placement on the follow-up visit.
At baseline, only 23.6% of the children were noted to have had no ear infections during the prior month. At the 3-month follow-up, the number of children reported to be infection free during the prior month increased to 81.0%, and this figure remained similar at later follow-up intervals. Similarly, the percentage of parents who reported that the approximate percentage of time that children had middle ear effusions was ⬎50% of the prior month dropped from 47.9% at baseline to less than 5% of parents at follow-up. OM-6 and OM QOL Results The average OM-6 score for all patients at enrollment was 3.02 ⫾ 1.1. The mean decrease for all patients (change score) was 1.17 ⫾ .13 at 3 months (P ⬍ 0.0001). In patients who had tympanostomy tube placement (PET), the average baseline OM-6 score was 3.14 ⫾ 1.1, and the mean OM-6 3-month change score was 1.65 (1.40 –1.89; 95% confidence interval [CI]; P ⬍ 0.0001). This improvement was sustained and significant at 6 and 9 months after surgery (P ⬍ 0.0001; Table 4). Parents were asked to rate the child’s overall QOL due to ear infections in the past 1 month (OM QOL) at 3, 6, and 12 months’ follow-up. On a scale of 1 to 10, a mean decrease (improvement) of –2.8 (P ⬍ 0.0001) was obtained at the 3-month follow-up for the children undergoing PET and was consistent for the later follow-up intervals. These results are shown in Table 5. Validation of the OM-6 The sensitivity (SRM) of the OM-6 in our group of patients was 1.2, indicating very high sensitivity to
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Table 3. Number of ear infections and percentage of time child spent with ear effusions during the past month for all children followed in COG*ENT Variable
Baseline (n ⴝ 253)
3 mo (n ⴝ 177)
6 mo (n ⴝ 140)
12 mo (n ⴝ 72)
41 23.6 74.1 2.4 0.0 0.0
9 81.0 19.0 0.0 0.0 0.0
6 73.9 26.1 0.0 0.0 0.0
3 81.2 18.8 0.0 0.0 0.0
38 33.0 19.1 14.9 33.0
7 90.0 5.3 0.6 4.1
9 85.5 8.4 3.8 2.3
2 87.1 10.0 0.0 2.9
No. of ear infections Missing (n) 0 (%) 1–3 (%) 4–6 (%) 7–9 (%) ⱖ10 (%) Percentage of time child spent with ear effusions Missing (n) 0–25 (%) 26–50 (%) 51–75 (%) 76–100 (%)
Table 4. Mean OM-6 scores at baseline and follow-up and mean change (baseline–follow-up)* for all children and those undergoing tympanostomy tube placement after baseline Follow-up (mo) All patients 3 Tympanostomy tube patients 3 6 ⱖ9
n
OM-6 baseline
OM-6 follow-up
Change score
95% CIs
155
3.0
1.8
1.2
1.0 to 1.3
100 75 30
3.1 3.1 3.2
1.4 1.5 1.6
1.7 1.5 1.6
1.3 to 1.9 1.2 to 1.8 1.1 to 2.2
Patients with follow-up but who did not complete the OM-6 are not included in this analysis. For follow-up versus baseline, all P values ⬍0.0001 (Wilcoxon signed rank test). *A positive value denotes improvement.
Table 5. Mean OM QOL scores at baseline and follow-up and mean change (baseline–follow-up)* for children undergoing tympanostomy tube placement after baseline Follow-up (mo)
n
QOL baseline
QOL follow-up
Change score
95% CIs
3 6 ⱖ9
90 69 28
6.4 6.7 6.5
9.1 9.0 9.3
⫺2.7 ⫺2.4 ⫺2.8
⫺3.2 to ⫺2.3 ⫺2.8 to ⫺1.9 ⫺3.6 to ⫺2.0
For follow-up versus baseline, all P values ⬍ 0.0001 (Wilcoxon signed rank test). *A negative value denotes improvement.
change. Good correlation (construct validity) between the OM-6 and the OM QOL was noted in our study group (r ⫽ – 0.50; P ⬍ 0.001). Lower (poorer) QOL scores at baseline are associated with higher (poorer) OM-6 scores at baseline. Our results regarding sensitivity and validity are similar to the results reported by Rosenfeld.4
Regression Analysis for Tympanostomy Tubes Univariate regression analysis was performed of children who underwent PET insertion. Table 6 shows the results of that analysis. In patients with OM who have PETs inserted, associations between clinical suc-
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Table 6. Predictors of clinical success in children with OM undergoing tympanostomy tube placement Predictor
P value
Chi-square
Odds ratio
95% CI for odds ratio
Born prematurely No. of diagnoses No. of children in daycare Other children at home under age 7 y
0.944 0.540 0.546 0.073
.005 .376 .365 3.222
.955 1.299 1.133 .460
.258–3.525 .561–3.012 .755–1.699 .195–1.084
No. of ear infections in past 3 mo
0.074
3.189
1.891
.913–3.917
Percentage of ear infections in past 3 months
0.002
9.441
1.940
1.243–3.029
Caregiver educational level
0.012
6.286
1.720
1.110–2.665
New patient to practice Child heath compared with 1 y ago Parent age Parent work status
0.544 0.194 0.343 0.004
.368 1.690 .899 8.228
1.391 1.394 1.044 2.883
.473–4.092 .837–2.322 .955–1.140 1.259–6.602
Suspected hearing loss Quality of life
0.485 0.0001
.487 14.776
1.423 .611
.530–3.821 .457–.817
Daycare Smoke at home Child age Gender Ethnic group Comorbidities
0.252 0.732 0.607 0.669 0.214 0.863
1.312 .117 .264 .183 1.542 .030
1.714 .827 1.055 .832 2.077 .906
.684–4.297 .277–2.468 .845–1.317 .358–1.932 .659–6.542 .295–2.78
Direction of effect
Negative. Other children at home associated with lower chance of success. Positive. More infections associated with better chance of success. Positive. Greater percentage of time with infection associated with better chance of success. Positive. Higher education level associated with better chance of success.
Positive. Working parents associated with better chance of success. Negative. Lower QOL score associated with better chance of success.
Predictors in bold typeface were noted to be significant in the univariate regression.
cess and the baseline OM-6 score, number of ear infections, and OM QOL score were found. Logistic modeling for predicting clinical success includes both the baseline OM-6 score (P ⬍ 0.0001; odds ratio ⫽ 10.42; 95% CI ⫽ 4.32–25.14) and caregiver years of schooling. Other clinical factors, such as presence in daycare, demographic factors, as well as comorbid illnesses, did not improve the model for predicting clinical success. The effect of medical treatment versus PET insertion was not compared because of the small number of children in the medically treated group (n ⫽ 15). DISCUSSION COG*ENT was established by the AAO-HNSF. In the OM module, COG*ENT prospectively collected data on patient-oriented outcomes after treatment by an otolaryngologist. Children were enrolled from multiple practice sites across the United States. Overall, children in our study improved significantly and reported fewer
ear infections at follow-up intervals. These data show that both the general and disease-specific QOL was better—substantially so—3 months after being evaluated and treated by an otolaryngologist. We cannot specifically quantify how much of this improvement was caused by physician management versus the natural history of OM. However, this observational study design shows that the improvement was recorded from the time of first visit to the otolaryngologist. Our study also shows that medical treatment with PET insertion was followed by improved disease-specific QOL for up to 9 months in some patients. This finding is consistent with findings of other authors who have measured good outcomes with tympanostomy tube insertion.9,10 The disease-specific domains of the OM-6 in which caregivers report large disease-specific improvements in QOL are physical suffering, emotional distress, and caregiver concerns. These 3 dimensions were also noted to be the most sensitive to change in the development of the OM-6.4
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The OM-6 survey appeared to be both valid and sensitive in our diverse study group, making it a good measurement for reporting OM outcomes in the community setting with diverse pediatric patient groups. The 3-month OM-6 mean change score was greater in the subset of children receiving PETs compared with in the entire group of children enrolled. This is likely due to the higher baseline OM-6 score (more burden of disease) that improves after the intervention. Unfortunately, we were not able to compare different treatment outcomes (medical vs. surgical) because of lack of sufficient numbers of patients in a medically treated group. Regression analysis was performed only on patients receiving PET insertion. Univariate regression analysis revealed several variables that were associated with clinical success after treatment of OM with tympanostomy tubes. These included infection severity (measured as number of infections and percentage of time with an infection), overall QOL impact of disease at presentation, caregiver educational level, employment of the parent, and baseline OM-6 score. These findings fall into 2 general categories: the first is measures of disease burden, and the second category is measures associated with socioeconomic status. When all of these variables are used in logistic analysis, only baseline OM-6 score and caregiver educational level remain significant. Further, modeling reveals that nearly all the variability in outcome can be explained by the baseline OM-6 score alone. Factors that other studies have shown to be associated with risk for recurrent OM or serous OM, such as use of day care, smoking at home, or presence of comorbid disease, were not significant in our study.2,11 Our regression analysis was different in that we examined children who already had indications for PET insertion due to OM rather than exploring which risk factors are associated with recurrent OM. Although these risk factors may have been present and significant in our group of patients in the development of the ear disease before PET insertion, these variables did not appear to be associated with clinical success after PET insertion. The finding of poorer QOL at presentation predicting larger improvement in QOL is not surprising and has been found in other studies, as long as the treatment is effective. Patients with poorer QOL have potentially more “room” for improvement and perhaps return closer to a disease-free baseline after successful treatment. Therefore, when attempting to predict improvement after treatment, measuring impact at baseline is very important. Strengths of this study include its prospective design, multicenter patient enrollment, and length of fol-
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low-up. These data represent a cross-section of otolaryngology practices and patients in the United States, rather than a single practice that might be focused on a particular study, treatment approach, or disease. The study design allowed for each physician to make treatment decisions as he or she would normally practice. Other prospective studies on outcomes after treatment of OM have found similarly favorable results. Large improvements in global, as well as disease-specific, QOL have been documented by several authors using validated OM questionnaires.12-14 Additionally, a meta-analysis of randomized clinical trials examining the efficacy of tympanostomy tubes in children has shown decreased time with middle ear effusion, reduction of the incidence of AOM, and short-term improvement in disease-specific QOL. The maximum benefit was seen from 6 to 12 months of follow-up, which is also seen in our multicenter prospective outcomes study.15 Our lack of tight controls on patient inclusion and exclusion criteria and treatment allocation would tend to increase outcome variability and dampen the effect in disease-specific QOL. The fact is intriguing that after otolaryngology management, the improvement was substantial (“large” by OM-6 criteria). Further study is required to understand how the different role and management strategies used by otolaryngologists impact the magnitude of their patients’ respective outcomes. Determining which treatment resulted in the greatest improvement in QOL was beyond the scope of this study and not part of its specific aims. Further, because the study was not controlled and used a convenience sample, we cannot determine whether the improvements that we saw were going to occur irrespective of whether or not the patient saw an otolaryngologist. The sampling strategy also does not allow us to describe the daily triage of the patients into a surgical or medical treatment regimen that occurs in usual practice. Our study was observational and did not randomly allocate treatment, whether medical, surgical, or watchful waiting, and this represents a limitation of the study for determining causality or efficacy of a specific treatment regimen. However, this report documents our earliest efforts in successfully organizing multicenter outcome studies. We acknowledge that the study serves more as a lesson learned and not as perfect science, but it lays the foundation for the Academy’s future plans to engage community practitioners from diverse practice settings and to facilitate their participation in future evidence-based medicine studies. The authors acknowledge the site investigators who contributed their time and effort in this study: Michael Widick, MD; Joseph Leonard, MD; Myron Yencha Jr, MD; Steven
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Peskind, MD; Donald Lewis, MD; Samuel Meadema, MD; Jerry Schreibstein, MD; Richard Waguespack, MD; Dennis Diaz, MD; James Hadley, MD; Rebecca Gaughan, MD; Arthur Hengerer, MD; Paul Loeffler, MD; Daniel Spilman, MD; C. Ron Cannon, MD; Jonathan Levine, MD; Chung-En Huang; Jean-Jacques Rafie, MD; Barry Jacobs, MD; Stephen Kupferberg, MD; Diana Tobon, MD; Dwight Ellerbe, MD; J. David Cunningham, MD; John Laurenzo, MD; Michael Dias, MD; J. Pablo Stolovitzky, MD; Scott Schaffer, MD, Reginald Rice, MD, Phillip Noel, MD; Lance Meyerson, MD. Additionally, the authors acknowledge the OM Task Force: Kenneth M. Grundfast, MD; Chair Margaretha Casselbrant, MD; George A. Gates, MD; Carol R. Gerson, MD; David R. Nielsen, MD; Seth M. Pransky, MD; Richard M. Rosenfeld, MD. REFERENCES 1. Rosenfeld RM. An evidence based approach to treating otitis media. Pediatr Clin North Am 1996;43:1165-81. 2. Klein JO, Teele DW, Pelton SI. New concepts in otitis media: results of investigations of the Greater Boston Otitis Media Study Group. Adv Pediatr 1992;39:127-56. 3. Gates GA. Cost-effective considerations in otitis media treatment. Otolaryngol Head Neck Surg 1996;114:525-30. 4. Rosenfeld RM, Goldsmith AJ, Tetlus L, et al. Quality of life for children with otitis media. Arch Otolaryngol Head Neck Surg 1997;123:1049-54.
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