DIAGNOSIS, INCIDENCE, AND DURATION OF OTITIS MEDIA IN DAYCARE-ATTENDING INFANTS AND TODDLERS

Transcription

1 The Pennsylvania State University The Graduate School College of Health and Human Development DIAGNOSIS, INCIDENCE, AND DURATION OF OTITIS MEDIA IN DAYCARE-ATTENDING INFANTS AND TODDLERS A Thesis in Communication Science and Disorders By Jackie M. Davie 2005 Jackie M. Davie Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy August 2005

2 The thesis of Jackie M. Davie has been reviewed and approved* by the following: Thomas A. Frank Professor of Communication Science & Disorders Thesis Adviser Chair of Committee Ingrid M. Blood Professor of Communication Science & Disorders Adele W. Miccio Associate Professor of Communication Science & Disorders Stephen A. Petrill Associate Professor of Biobehavioral Health Robert A. Prosek Professor of Communication Science & Disorders Gordon W. Blood Professor of Communication Science & Disorders Head of the Department of Communication Science & Disorders * Signatures are on file in the Graduate School.

3 iii ABSTRACT The purpose of this study was to assess the feasibility and effectiveness of using pneumatic otoscopy and tympanometry measurements to diagnose otitis media (OM) in infants and toddlers attending daycare. In addition, the incidence and duration of OM in these infants and toddlers was evaluated. Finally, the ages of the children studied were analyzed to determine if it was a factor affecting these four issues. During this longitudinal study, 10,245 weekly health screenings were attempted on 132 daycare-attending children between 6 months to just over 36 months of age. A complete pneumatic otoscopy examination for each ear was completed for only 60% of all health screenings. However, a complete tympanometry measurement for each ear was completed for 84% of all screenings. If a complete pneumatic otoscopy and tympanometry evaluation was obtained, the child was more likely to be diagnosed with OM, suggesting that OM may be under diagnosed. The ability to complete pneumatic otoscopy and tympanometry improved with age. Statistically significant differences were noted for all of the pneumatic otoscopy descriptors and tympanometry measures except ear canal volume (ECV) based on ear health diagnosis (healthy versus OM). However, neither pneumatic otoscopy nor tympanometry was an ideal tool to diagnose OM in this group of children. Pneumatic otoscopy was often difficult to obtain, particularly if the children were under 24 months of age. Further, even though most tympanometry measures were statistically different between groups, several of the tympanometry measures did not clearly distinguish healthy ears from ears with OM due to measurement overlap. Age was a significant factor in all pneumatic otoscopy and tympanometry measures. These children were frequently ill. Only 40% of health screening diagnoses were classified as healthy. Ninety-nine percent (99%) of the children suffered from at least one episode of OM. The average child had OM for 20 weeks during their participation in the study. Nearly half of the children were labeled as Chronic OM even though their experience with OM was due primarily to episodes of unilateral (rather than bilateral) OM. This finding suggests that the current definition of Chronic OM may need to be re-evaluated.

4 iv TABLE OF CONTENTS ABSTRACT...iii LIST OF FIGURES....v LIST OF TABLES......ix ACKNOWLEDGEMENTS...xi CHAPTER 1. 1 INTRODUCTION.1 General Cause of OM Classification of OM....2 Incidence of OM Duration of OM Incidence and Duration of OM Diagnosis of OM... 7 Pneumatic Otoscopy Tympanometry...10 Hearing Thresholds...13 Research Objectives CHAPTER METHODS Children Procedure and Instrumentation Health Screening Ear Health Reliability of OM Diagnosis.. 23 PE Tube.24 CHAPTER RESULTS AND DISCUSSION Feasibility of Obtaining Pneumatic Otoscopy and Tympanogram Measurements...26 Health Diagnosis...28 Incidence of OM Duration of OM Diagnosis of OM OM Diagnosis with Pneumatic Otoscopy Alone..35 OM Diagnosis with Tympanometry Alone..40 Comparison to Referral Criteria...46 Pneumatic Otoscopy and Tympanometry Combined for Diagnosing OM...47 Summary...49 CHAPTER CONCLUSIONS Further Research...81 REFERENCES...84 APPENDIX A: WEEKLY HEALTH SCREENING CODING FORM..88 APPENDIX B: INDIVIDUAL CHILD HEALTH DIAGNOSIS INFORMATION.91 APPENDIX C: AGE RELATED PNEUMATIC OTOSCOPY DESCRIPTOR MEASURES 110 APPENDIX D: AGE RELATED TYMPANOMETRY VALUES 132

5 v LIST OF FIGURES FIQURE 1.1. EXAMPLE OF A NORMAL TYMPANOGRAM FIGURE 1.2. TYMPANOGRAM SHOWING THAT EAR CANAL VOLUME (ECV) IS DERIVED BY DETERMINING THE EQUIVALENT EAR CANAL VOLUME WHEN THE EAR CANAL AIR PRESSURE IS 200 DAPA. FOR THIS TYMPANOGRAM, THE ECV IS 0.6 CM FIGURE 1.3. TYMPANOGRAM SHOWING THAT THE MIDDLE EAR PEAK PRESSURE (PP) IS DERIVED BY DETERMINING THE DAPA VALUE CORRESPONDING TO THE MAXIMUM PEAK COMPLIANCE OF THE TYMPANOGRAM. FOR THIS TYMPANOGRAM THE MIDDLE EAR PRESSURE WAS 0 DAPA FIGURE 1.4. TYMPANOGRAM SHOWING THAT THE PEAK COMPLIANCE (PC) IS DERIVED BY DETERMINING THE DIFFERENCE BETWEEN THE EQUIVALENT VOLUME AT THE PEAK OF THE TYMPANOGRAM MINUS THE EQUIVALENT VOLUME AT 200 DAPA. FOR THIS TYMPANOGRAM THE PC WAS 1.0 CM FIGURE 1.5. TYMPANOGRAM SHOWING THAT THE TYMPANIC WIDTH (TW) IS DERIVED BY DETERMINING THE DAPA RANGE CORRESPONDING TO A 50% REUCTION ON EITHER SIDE OF THE PC. FOR THIS TYMPANOGRAM THE TW WAS 185 DAPA (-75 TO 75 = 150 DAPA) FIGURE 1.6. EXAMPLE OF A FLAT TYMPANOGRAM FIGURE 1.7. EXAMPLE OF A NEGATIVELY PEAKED TYMPANOGRAM FIGURE 3.1. DISTRIBUTION OF THE NUMBER OF COMPLETED HEALTH DIAGNOSES FIGURE 3.2. PERCENT OF COMPLETED PNEUMATIC OTOSCOPY AND TYMPANOMETRY SCREENINGS FOR EACH AGE IN MONTHS FIGURE 3.3. PERCENT OF COMPLETED COMBINED PNEUMATIC OTOSCOPY AND TYMPANOMETRY SCREENINGS EACH AGE IN MONTHS FIGURE 3.4. PERCENT OF COMPLETED PNEUMATIC OTOSCOPY AND TYMPANOMETRY SCREENINGS FOR EACH HEALTH DIAGNOSIS FIGURE 3.5. PERCENT OF COMPLETE COMBINED PNEUMATIC OTOSCOPY AND TYMPANOMETRY SCREENINGS FOR EACH HEALTH DIAGNOSIS FIGURE 3.6. PERCENTAGE OF HEALTHY, BILATERAL OM, AND UNILATERAL OM DIAGNOSES FOR THE TOTAL SAMPLE AND FOR EACH 6-MONTH AGE RANGE FIGURE 3.7. THE NUMBER OF CHILDREN AND WEEKS EACH CHILD S HEALTH DIAGNOSIS WAS HEALTHY.69 FIGURE 3.8. THE NUMBER OF CHILDREN AND WEEKS WITH UNILATERAL OM FIGURE 3.9. THE DISTRIBUTION OF THE NUMBER OF CHILDREN AND WEEKS WITH BILATERAL OM FIGURE THE NUMBER OF CHILDREN WITH HEALTH DIAGNOSES AS HEALTHY AS A PERCENTAGE OF TOTAL HEALTH DIAGNOSES FOR EACH CHILD FIGURE THE NUMBER OF CHILDREN WITH HEALTH DIAGNOSES OF UNILATERAL OM AS A PERCENTAGE OF TOTAL HEALTH DIAGNOSES FOR EACH CHILD FIGURE THE NUMBER OF CHILDREN WITH HEALTH DIAGNOSES OF BILATERAL OM AS A PERCENTAGE OF TOTAL HEALTH DIAGNOSES FOR EACH CHILD FIGURE PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR EACH PNEUMATIC OTOSCOPY TM COLOR DESCRIPTORS FIGURE PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR EACH PNEUMATIC OTOSCOPY TM POSITION DESCRIPTORS FIGURE PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR EACH PNEUMATIC OTOSCOPY TM APPEARANCE DESCRIPTOR FIGURE 3.16 PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM LANDMARK DESCRIPTOR FIGURE PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM MOBILITY DESCRIPTOR FIGURE PERCENTAGE OF EAR CANAL VOLUME MEASURES FOR CHILDREN S DIAGNOSED AS HAVING HEALTHY OR OM USING PNEUMATIC OTOSCOPY FIGURE PERCENT OF EARS HAVING PEAK PRESSURE FOR CHILDREN DIAGNOSED AS HAVING HEALTHY OR OM EARS USING PNEUMATIC OTOSCOPY FIGURE PERCENT OF EARS HAVING PEAK COMPLIANCE FOR CHILDREN DIAGNOSED AS HAVING HEALTHY OR OM EARS USING PNEUMATIC OTOSCOPY FIGURE 3.21.PERCENT OF EARS HAVING TYMPANIC WIDTH FOR CHILDREN DIAGNOSED AS HAVING HEALTHY OR OM EARS USING PNEUMATIC OTOSCOPY

6 FIGURE C.1. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE < 6 MONTHS FIGURE C.2. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 6 TO < 11 MONTHS FIGURE C.3. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 12 TO < 17 MONTHS FIGURE C.4. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 18 TO < 23 MONTHS FIGURE C.5. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 6 TO < 11 MONTHS FIGURE C.6. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 30 TO < 35 MONTHS FIGURE C.7. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE > 36 MONTHS FIGURE C.8. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE < 6 MONTHS FIGURE C.9. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE 6 TO < 11 MONTHS FIGURE C.10. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE 12 TO < 17 MONTHS FIGURE C.11. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE 18 TO < 23 MONTHS FIGURE C.12. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE 24 TO <29 MONTHS FIGURE C.13. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE 30 TO < 35 MONTHS FIGURE C.14. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGE > 36 MONTHS FIGURE C.15. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE < 6 MONTHS FIGURE C.16. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 6 TO < 11 MONTHS FIGURE C.17. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGE 12 TO < 17 MONTHS FIGURE C.18. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR APPEARANCE FOR AGE 18 TO < 23 MONTHS FIGURE C.19. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR APPEARANCE FOR AGE 24 TO <29 MONTHS FIGURE C.20. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR APPEARANCE FOR AGE 30 TO < 35 MONTHS FIGURE C.21. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR APPEARANCE FOR AGE > 36 MONTHS FIGURE C.22. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE < 6 MONTHS FIGURE C.23. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE 6 TO < 11 MONTHS FIGURE C.24. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE 12 TO < 17 MONTHS FIGURE C.25. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE 18 TO < 23 MONTHS FIGURE C.26. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE 24 TO <29 MONTHS FIGURE C.27. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE 30 TO < 35 MONTHS FIGURE C.28. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGE > 36 MONTHS vi

7 FIGURE C.29. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE < 6 MONTHS FIGURE C.30. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE 6 TO < 11 MONTHS FIGURE C.31. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE 12 TO < 17 MONTHS FIGURE C.32. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE 18 TO < 23 MONTHS FIGURE C.33. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE 24 TO <29 MONTHS FIGURE C.34. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE 30 TO < 35 MONTHS FIGURE C.35. PERCENTAGE OF THE CHILD S HEALTH DIAGNOSIS FOR THE PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGE > 36 MONTHS FIGURE D.1. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT EAR CANAL VOLUME (ECV) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 6 TO >11 MONTHS FIGURE D.2. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT EAR CANAL VOLUME (ECV) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 12 TO >18 MONTHS FIGURE D.3. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT EAR CANAL VOLUME (ECV) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 18 TO > 23 MONTHS FIGURE D.4. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT EAR CANAL VOLUME (ECV) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 24 TO >29 MONTHS FIGURE D.5.PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT EAR CANAL VOLUME (ECV) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY - 30 TO > 35 MONTHS FIGURE D.6. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT EAR CANAL VOLUME (ECV) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 36 TO 41 MONTHS FIGURE D.7. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK PRESSURE (PP) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 6 TO >11 MONTHS FIGURE D.8. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK PRESSURE (PP) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 12 TO >17 MONTHS FIGURE D.9. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK PRESSURE (PP) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 18 TO >23 MONTHS FIGURE D.10. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK PRESSURE (PP) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 24 TO >29 MONTHS FIGURE D.11. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK PRESSURE (PP) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 30 TO >35 MONTHS FIGURE D.12. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK PRESSURE (PP) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY < 36 MONTHS FIGURE D.13. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT TYMPANIC WIDTH COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 6 TO 11 MONTHS FIGURE D.14. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT TYMPANIC WIDTH COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 12 TO 17 MONTHS FIGURE D.15. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT TYMPANIC WIDTH COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 18 TO 23 MONTHS FIGURE D.16. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT TYMPANIC WIDTH COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 24 TO 29 MONTHS vii

8 FIGURE D.17. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT TYMPANIC WIDTH COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 30 TO 35 MONTHS FIGURE D.18. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT TYMPANIC WIDTH COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY <36 MONTHS FIGURE D.19. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK COMPLIANCE (PC) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 6 TO >11 MONTHS FIGURE D.20. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK COMPLIANCE (PC) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 12 TO >17 MONTHS FIGURE D.21. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK COMPLIANCE (PC) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 18 TO >23 MONTHS FIGURE D.22. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK COMPLIANCE (PC) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 24 TO >29 MONTHS FIGURE D.23. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK COMPLIANCE (PC) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY 30 TO > 35 MONTHS FIGURE D.24. PERCENTAGE OF THE TYMPANOMETRY MEASUREMENT PEAK COMPLIANCE (PC) COMPARED TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY <36 MONTHS viii

9 ix LIST OF TABLES TABLE 3.1. NUMBER AND PERCENTAGE OF HEALTH SCREENINGS ATTEMPTED, HEALTH SCREENINGS WHERE A HEALTH DIAGNOSIS COULD BE MADE, HEALTH SCREENINGS THAT INCLUDED COMPLETE PNEUMATIC OTOSCOPY AND/OR TYMPANOMETRY FOR THE TOTAL SAMPLE AND BY SIX-MONTH AGE GROUPS TABLE 3.2. NUMBER AND PERCENT OF ATTEMPTED AND COMPLETED PNEUMATIC OTOSCOPY SCREENINGS PER AGE TABLE 3.3. NUMBER AND PERCENT OF ATTEMPTED AND COMPLETED PNEUMATIC OTOSCOPY SCREENINGS PER AGE TABLE 3.4 NUMBER AND PERCENT OF ATTEMPTED AND COMPLETED PNEUMATIC OTOSCOPY SCREENINGS PER AGE TABLE 3.5. NUMBER AND PERCENT OF COMPLETED AND ATTEMPTED PNEUMATIC OTOSCOPY AND TYMPANOMETRY SCREENINGS PER HEALTH DIAGNOSIS TABLE 3.6. NUMBER AND PERCENT OF COMPLETED AND ATTEMPTED PNEUMATIC OTOSCOPY AND TYMPANOMETRY SCREENINGS PER HEALTH DIAGNOSIS TABLE 3.7. NUMBER AND PERCENT OF HEALTH DIAGNOSES BY AGE GROUP TABLE 3.8. NUMBER AND PERCENTAGE OF (TM) COLOR DESCRIPTORS FOR THE CHILD S HEALTH DIAGNOSIS TABLE 3.9. NUMBER AND PERCENTAGE OF THE TM POSITION DESCRIPTORS FOR THE CHILD S HEALTH DIAGNOSIS TABLE NUMBER AND PERCENTAGE OF TM APPEARANCE DESCRIPTORS FOR THE CHILD S HEALTH DIAGNOSIS TABLE NUMBER AND PERCENTAGE OF TM LANDMARK DESCRIPTORS FOR THE CHILD S HEALTH DIAGNOSIS TABLE PERCENTAGE AND NUMBER OF TM MOBILITY DESCRIPTORS FOR THE CHILD S HEALTH DIAGNOSIS TABLE NUMBER OF CHRONIC OM CHILDREN WHO HAD UNILATERAL OM COMPARED TO BILATERAL OM WHEN DIAGNOSIS OF UNILATERAL/BILATERAL OM WAS BASED ON PNEUMATIC OTOSCOPY: THE NUMBER OF WEEKS SPENT WITH UNILATERAL OM VERSUS BILATERAL OM TABLE NUMBER OF NON-CHRONIC OM CHILDREN WHO HAD UNILATERAL OM COMPARED TO BILATERAL OM WHEN DIAGNOSIS OF UNILATERAL/BILATERAL OM WAS BASED ON PNEUMATIC OTOSCOPY: THE NUMBER OF WEEKS SPENT WITH UNILATERAL OM VERSUS BILATERAL OM TABLE TEST-RETEST RELIABILITY FOR THE TYMPANOMETRY MEASURES TABLE NUMBER AND PERCENT OF EAR CANAL VOLUME (ECV) MEASUREMENTS TO SPECIFIC HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY TABLE NUMBER AND PERCENT OF PEAK PRESSURE (PP) MEASUREMENTS FOR EARS DIAGNOSED AS HEALTHY OR OM USING PNEUMATIC OTOSCOPY TABLE NUMBER AND PERCENT OF PEAK COMPLIANCE (PC) MEASUREMENTS FOR EARS DIAGNOSED AS HEALTHY OR OM USING PNEUMATIC OTOSCOPY TABLE PERCENTAGE OF TYMPANIC WIDTH (TW) MEASUREMENTS FOR EARS DIAGNOSED AS HEALTHY OR OM USING PNEUMATIC OTOSCOPY TABLE SUMMARY STATISTICS FOR ALL OF THE TYMPANOMETRY MEASUREMENTS FOR EARS DIAGNOSED AS HEALTHY OR OM USING PNEUMATIC OTOSCOPY TABLE SENSITIVITY, SPECIFICITY, AND EFFICIENCY FOR THE TYMPANOMETRY MEASURES IN THE PRESENT STUDY USING THE NURSES DIAGNOSIS OF HEALTHY OR OM AS APPLIED TO SCREENING REFERRAL CRITERIA REPORTED BY AAA (1997), ASHA (1990), AND NOZZA, ET.AL., (1994) TABLE SENSITIVITY, SPECIFICITY, OVER-REFERRAL AND EFFICIENCY FOR THE TYMPANOMETRY MEASURES IN THE PRESENT STUDY USING PNEUMATIC OTOSCOPY FOR THE DIAGNOSIS OF HEALTHY OR OM AS APPLIED TO SCREENING REFERRAL CRITERIA REPORTED BY AAA (1997), ASHA (1990), AND NOZZA, ET.AL., (1994) TABLE NUMBER AND PERCENT OF EAR HEALTH DIAGNOSES AS HEALTHY OR OM USING TYPICAL COMBINED OM PNEUMATIC OTOSCOPY AND TYMPANOMETRY INDICATORS WHERE A FLAT TYMPANOGRAM = TW > 300DAPA OR PC > 0.1CM 3 (NOZZA ET AL., 1994) TABLE B.1. NUMBER AND PERCENT AND TOTAL NUMBER OF OF HEALTH DIAGNOSES PER CHILD AS HEALTHY, UNILATERAL OM, BILATERAL OM, URP, AND OTHER

10 TABLE B.2. PERCENTAGE OF HEALTH DIAGNOSES FOR EACH CHILD WHEN HEALTH DIAGNOSIS WAS BASED ON A COMPLETE PNEUMATIC OTOSCOPY SCREENING TABLE B.3. TOTAL WEEKS FOR EACH HEALTH DIAGNOSES FOR EACH CHILD WHEN HEALTH DIAGNOSIS WAS BASED ON A COMPLETE PNEUMATIC OTOSCOPY SCREENING TABLE B.4. PERCENTAGE OF TOTAL HEALTH DIAGNOSES FOR EACH CHILD BASED ON NURSE DIAGNOSIS. CLASSIFICATION OF CHRONIC WAS BASED ON PERCENTAGE OF NURSE DIAGNOSES DESIGNATED AS OM THROUGH AGE 24 MONTHS, IF THE CHILD HAD AT LEAST 15 HEALTH SCREENINGS. A CHILD WAS CONSIDERED CHRONIC FOR OM IF 30% OR MORE OF THEIR TOTAL PERCENTAGE OF HEALTH DIAGNOSES WERE RECORDED AS EITHER UNILATERAL AND/OR BILATERAL OM TABLE B.5. TOTAL WEEKS OF EACH HEALTH DIAGNOSES FOR EACH CHILD WHEN HEALTH DIAGNOSIS WAS BASED ON NURSE DIAGNOSIS TABLE C.1. PERCENTAGE OF HEALTHY CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGES < 6 TO > 36 MONTHS TABLE C.2. PERCENTAGE OF OM CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR COLOR FOR AGES < 6 TO > 36 MONTHS TABLE C.3. PERCENTAGE OF HEALTHY CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGES < 6 TO > 36 MONTHS TABLE C.4. PERCENTAGE OF OM CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR POSITION FOR AGES < 6 TO > 36 MONTHS TABLE C.5. PERCENTAGE OF HEALTHY CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR APPEARANCE FOR AGES < 6 TO > 36 MONTHS TABLE C.6. PERCENTAGE OF OM CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR APPEARANCE FOR AGES < 6 TO > 36 MONTHS TABLE C.7. PERCENTAGE OF HEALTHY CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGES < 6 TO > 36 MONTHS TABLE C.8. PERCENTAGE OF OM CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR LANDMARKS FOR AGES < 6 TO > 36 MONTHS TABLE C.9. PERCENTAGE OF HEALTHY CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGES < 6 TO > 36 MONTHS TABLE C.10. PERCENTAGE OF OM CHILD S HEALTH DIAGNOSES COMPARED FOR EACH PNEUMATIC OTOSCOPY TM DESCRIPTOR MOBILITY FOR AGES < 6 TO > 36 MONTHS TABLE D.1. SUMMARY STATISTICS FOR TYMPANOMETRY BASED ON HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY- AGE 6 TO <11 MONTHS TABLE D.2. SUMMARY STATISTICS FOR TYMPANOMETRY BASED ON HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY- AGE 12 TO <17 MONTHS TABLE D.3. SUMMARY STATISTICS FOR TYMPANOMETRY BASED ON HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY- AGE 18 TO <23 MONTHS TABLE D.4. SUMMARY STATISTICS FOR TYMPANOMETRY BASED ON HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY- AGE 24 TO < 29 MONTHS TABLE D.5. SUMMARY STATISTICS FOR TYMPANOMETRY BASED ON HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY- AGE 30 TO < 35 MONTHS TABLE D.6. SUMMARY STATISTICS FOR TYMPANOMETRY BASED ON HEALTH DIAGNOSIS USING COMPLETE PNEUMATIC OTOSCOPY- AGE > 36 MONTHS x

11 xi ACKNOWLEDGEMENTS This research was funded in part by grant #HD31540 to Lynne Vernon-Feagans, Ph.D., from the National Institute of Child Health and Human Development. I would like to thank my advisor, Tom Frank, PhD., for all his expertise and advice during the completion of this paper. I would like to thank my committee members for their patience and understanding throughout this entire process. I would like to thank my teaching assistants, Marcia Gilbert, Kerry Dorffner, Kristen Hunter, and Rita Wahab, for helping to make all of the corrections, creating tables and graphs, and for keeping my desk organized. Most importantly, I would like to thank my husband, Erik Weidenboerner, for keeping our life together at home.

12 1 Chapter 1 Introduction Middle ear infection with effusion (fluid), commonly referred to as Otitis Media (OM), has a high incidence and prevalence in the pediatric population of the United States. OM is the second-most diagnosed illness in early childhood, particularly from six to 20 months of age (Kaleida, 1997; Paradise et al. 1997; Teele, Klein, Roesner, & The Greater Boston Otitis Media Study Group, 1989). Paradise et al. (1997) reported that 91% of children had at least one episode of OM by two years of age. Though episodes of OM usually subside in several weeks, the effusion remains for three months or longer in up to 25% of the cases (Marchant, Shurin, Turczyk, Wasikowski, Tutihasu, & Kenney, 1984; Schwartz, Rodriguez, & Grundfast, 1984). Further, increased episodes of OM have been associated with several risk factors, including frequent exposure to other children, lower socio-economic status, and gender (repeated or elongated episodes being more prominent in males than females) (Paradise et al., 1997). The high incidence and prevalence of OM has many health care practitioners concerned. This concern is largely due to the fact that OM has been associated with hearing loss, which for some children can cause delays in speech and language development, decrease attention, and increase behavioral problems (Sabo, Paradise, Kurs-Lasky, and Smith, 2003; Gravel & Wallace, 2000; Werner & Ward, 1997; Fria, Cantekin, & Eichler, 1985). Additional concerns regarding the definition and numerous classifications of OM have arisen (Linsk & Cooke, 2004). There has been disagreement between health care practitioners regarding the best methods to diagnose OM and a lack of research regarding the feasibility of conducting several diagnostic tests for OM in infants and toddlers (Takata et al., 2003). General Cause of OM Generally, OM with effusion is caused by Eustachian tube dysfunction. The primary functions of the Eustachian tube are to aerate the middle ear cavity, protect the middle ear cavity

13 2 from invading microbes, and clear the middle ear of secretions. Developmentally, a child s Eustachian tube is prone to dysfunction because it is shorter, more flaccid, and situated at an almost horizontal position compared with an adult s Eustachian tube. These Eustachian tube factors contribute to making a child s middle ear cavity more susceptible to bacteria reflux from the nasopharynx, infection, and fluid build-up. Without proper Eustachian tube function, over time, negative air pressure builds up in the middle ear cavity, causing a retracted tympanic membrane. Negative pressure causes production of fluid from the mucosal lining. The fluid produced is an ideal environment for bacteria growth. Classification of OM OM with effusion (meaning fluid occupies the middle ear cavity without evidence of infection) is the most commonly used classification of middle ear disease. An incidence report written by the National Center for Health estimates that 25 to 35% of all middle ear diseases have a primary diagnosis of OM with effusion (Schappert, 1992). However, other classifications and terms for middle ear disease are often utilized and are usually based on the type or cause of fluid. Classifications include serous otitis media, secretory otitis media, allergic otitis media, catarrhal otitis media, nonsuppurative otitis media, mucoid otitis media, secondary otitis media, hydrotubotympanum, exudative catarrh, tubotympanitis, tympanic hydrops, glue ear, fluid ear, and tubotympanic catarrh (Stool et al., 1994). OM can also be classified based on the physical characteristics and duration of the disease. The physical classifications include OM without effusion, OM with perforation, OM with effusion where effusion can be classified as serous (thin and watery), purulent (pus like), mucoid (thick, mucous like), and suppurative (blood filled) (Paparella & Schachern, 1994). Classifications of OM based on duration include acute (< 21 days), subacute (21 days to 8 weeks), and chronic (> 8 weeks). OM can also be classified as symptomatic or asymptomatic. While symptomatic OM is typically associated with behavioral changes, fever, and/or ear pain, asymptomatic OM

14 3 typically has no outward signs (i.e., visible signs), and is therefore sometimes called silent OM (Paparella & Schachern, 1994). In fact, children who are diagnosed with OM sometimes have parents who are not aware OM is present because the child is asymptomatic. Incidence of OM Numerous studies have evaluated the incidence of OM in pediatric populations. Incidence was defined as the number of new cases of a disease during a designated period based on sample number. OM incidence rates varied relative to the child s age, diagnostic measure, and diagnostic criteria. Active surveillance studies have reported a higher incidence of OM than passive surveillance studies. This occurred because active studies were more likely to detect asymptomatic (i.e., silent OM) or transient OM episodes. Overall, the reported OM incidence rates varied between 35 to 99%. The highest incidence typically occurred when children were evaluated between 6 and 18 months of age (Owen et al., 1993; Teele et al., 1990). Recent studies have suggested an overall increase in the incidence of OM in recent years. Other OM incidence studies reported that children who were exposed to other children were more likely to have had OM (Paradise et al., 1997), suggesting that children who attend daycare are at a higher risk for developing OM. Auinger, Lanphear, Kalkwarf, & Mansour (2003) found that 78-81% of daycare-attending children had at least one episode of OM (regardless of the amount of time spent in daycare), compared with 61% of children kept at home. Additionally, studies have suggested that gender and socioeconomic status (SES) are factors that influence OM incidence. Specifically, males were more likely than females to have had OM (Paradise et al., 1997) and children with lower SES as opposed to higher SES were more likely to have had OM (Paradise et al., 1997).

15 4 In summary, OM incidence appeared to be the highest in the above-referenced studies for children between 6 and 18 months of age, who attended daycare, were male, and were from lower SES homes. Duration of OM The reported duration of a typical OM episode varied between studies. For the most part, this occurred because of the frequency at which diagnostic screenings were conducted and the assumptions made regarding the child s otologic status between screenings. Typically, the otologic status of a child s ear(s) was considered constant if there was no change in the child s otologic status from one screening to the next. However, if the otologic status changed, the duration of OM was typically considered to be half of the time between screenings. Reports of the average duration of an OM episode ranged from 7 to 36% of the total time of the child s age from birth to 36 months old (Teele et al., 1990; Vernon-Feagans, Emanuel, & Blood, 1997). The duration of single or multiple episodes of OM are of great interest to hearing health care practitioners. Children having long or multiple episodes of OM are thought to experience more outcomes that are negative because they are more likely to have prolonged hearing loss. Hearing loss associated with OM is very well known and has been hypothesized to cause several negative outcomes. Therefore, the studies often grouped children based on of the duration of their OM. Children with no OM or a very short total duration of OM were usually called nonchronic. On the other hand, children with a longer total duration of OM were called chronic (Vernon-Feagans et al., 1997; Teele, Klein, & Rosner, 1989; Teele et al., 1984; Friel-Patti, Finitzo-Heiber, Conti, & Brown, 1982). Chronic OM has been defined based on the amount of time and/or the percentage of time a child has OM. The Greater Boston Otitis Media Group defined a child having chronic OM as one who had OM for a sum total of >2.5 months within a 12-month period (Teele et al., 1989; Teele et al., 1984; Friel-Patti et al., 1982). The Penn State Otitis Media Research Project defined

16 5 chronic OM as a child having a diagnosis of OM for >20% of the total proportion of that child s diagnoses (Vernon-Feagans et al., 1997). Recently, this has been changed to an OM diagnosis for >30% of the total number of diagnoses (Vernon-Feagans & Wamboldt, 2002) where the percentage of the diagnosis for determining chronic OM is based on a median split of the cumulative number of OM diagnoses. There is no single accepted definition for chronic OM in children. This is important because several studies have compared non-chronic with chronic OM children in reference to speech and language development, attention, behavior, etc. For example, a child may be classified as chronic OM if he/she has had multiple episodes of OM where each episode lasted less than a week. As another example, a child may be classified as chronic OM if he/she has had a single continuous episode of OM. Additionally, a classification of chronic OM may be given to a child who has had repeated episodes of unilateral OM. As such, even though a group of children may be diagnosed as having chronic OM, children within this classification may have different listening experiences, which may in turn influence the results of studies comparing non-chronic with chronic OM children. Incidence and Duration of OM The following section summarizes the findings of several studies that illustrated differences in the reported incidence and duration of OM. The Greater Boston Otitis Media Group evaluated 205 children and followed them prospectively from birth to age three (Teele et al., 1984; Teele et al., 1990). OM was most prevalent during the child s first year but the total duration of OM was not normally distributed, since 26.9% of children had OM for 0-29 days, 13.4% for days, 8.8% for days, and 50.8% for more than 90 days. These data suggest that children either had a short (non-chronic) or long (chronic) duration of OM before turning three years of age.

17 6 Roland et al. (1989) prospectively assessed 483 infants evaluated for OM during monthly well-baby and daycare/home visits from 6 to 36 months of age. By 18 months, 73.5% of the children had at least one episode of OM. Half of the episodes were bilateral and the other half was unilateral. The median duration of OM was 62 days per year. Roberts, Burchinal, and Campbell (1994) and Roberts et al. (1989) evaluated the health status of 55 children with lower socioeconomic status biweekly for their first five years of life. The median number of OM episodes per child was seven. The median number of days with OM was 147 through age five. Interestingly, the duration of OM was highly positively skewed. This would suggest that several children had long durations of OM while the majority had shorter durations. Overall, 74% of all the OM episodes occurred before age 2 and 92% before age 3. Paradise et al. (1997) studied 2253 children in the Pittsburgh area. They reported that OM was the second-most diagnosed disease in children, next to the common cold. Overall, 91.1% of the children were diagnosed with at least one episode of OM. The cumulative proportion of days with OM was 20.4% of the child s first year and 16.6% of the child s second year of life. The total percentages of children developing one or more episode of OM between the start of the study and 6, 12, and 24 months of age were 47.8%, 78.9%, and 91.1% respectively. These studies agree that children have the highest incidence of OM in their first two years of life and that the duration of OM is highly positively skewed, where most children have OM for short periods (<90 days) while some children have OM for longer durations. However, there were notable differences in the incidence and duration of OM between the studies. These differences can be attributed to several factors, including the frequency of assessment, diagnostic technique and criteria, and treatment. The frequency of assessment varied from sick visits to the physician (Paradise et al., 1997) to biweekly screenings by a nurse practitioner (Roberts et al., 1989 and Roberts et al., 1994). If a child was not evaluated on a regular basis and assumptions about the child s otological status between examinations were made, the accuracy of the incidence and duration of OM can be questioned.

18 7 The diagnosis of OM in these studies was determined using numerous techniques and criteria, including myringotomy, tympanocentesis, pneumatic otoscopy, tympanometry, ipsilateral acoustic reflex, and hearing tests. The criteria varied from visible effusion to an inflamed tympanic membrane (TM) with or without ottorhea, to flat tympanograms, to absent ipsilateral acoustic reflexes, to hearing loss. Diagnosis of OM Recently, the Agency for Health Care Policy and Research (Stool et al., 1994) and the Agency for Healthcare Research and Quality (Subcommittee on Otitis Media with Effusion, 2004) evaluated techniques for diagnosing OM. In their conclusions, the panel noted that myringotomy, pneumatic otoscopy, and tympanometry were the only assessment tools with research supporting their use for the diagnosis of OM. Further, they reported that each diagnostic tool had its positive and negative aspects and no single technique was infallible. They concluded that pneumatic otoscopy should be used as the primary diagnostic method for the diagnosis of OM (particularly to distinguish OM with effusion from acute OM) and tympanometry could be used to verify the OM diagnosis (Subcommittee on Otitis Media with Effusion, 2004). Accurate diagnosis of OM is often difficult, especially in young children (Kaleida, 1997). Visualization of the TM might not be possible due to the lack of cooperation from the child or because of small ear canals. In addition, some children with OM may not exhibit outward symptoms such as fever and earache; consequently, medical attention may not be sought (Carlson & Stool, 1997; Roland et al., 1989; Stool et al., 1994). The most accurate diagnosis of OM with effusion requires inspection of the middle ear cavity, done by making an incision in the TM and examining the contents of the middle ear cavity. This procedure, called myringotomy (with or without tympanocentesis), was once considered the gold standard for determining the presence of OM with effusion. However, since every child suspected of having OM cannot have an invasive myringotomy, it is not an efficient or appropriate

19 8 diagnostic procedure. In addition, visual inspection of the entire contents of the middle ear cavity makes it a subjective measure (Nozza, Bluestone, & Kardatzke, 1992). Thus, practitioners have turned to using non-invasive methods to diagnose OM. However, exactly which non-invasive technique is best suited for diagnosing OM has lead to considerable debate. As previously mentioned, an expert panel (Stool et al., 1994; Subcommittee on Otitis Media with Effusion, 2004) debated the appropriate methods for diagnosing OM for several years. This occurred in part because age is a major problem in diagnosing OM in children. Children cannot provide a relevant case history, may not be cooperative for a physical examination, or may not have large enough ear canals to allow for visualization of the TM. The expert panel recommended otoscopy and pneumatic otoscopy for screening children suspected of having OM, and that tympanometry be used to confirm the presence of OM. Several other organizations have made recommendations regarding the diagnosis of OM. The Vermont Program for Quality in Health Care (1996) recommended the use of pneumatic otoscopy for the diagnosis of OM and hearing assessment when children have prolonged durations of OM. The American Speech Language Hearing Association s (ASHA, 1997) guidelines for screening outer and middle ear disease include otoscopy and tympanometry with an optional case history. The American Academy of Audiology Position Statement (AAA, 1997) on the identification of middle ear dysfunction recommends tympanometry and acoustic reflexes accompanied by a hearing screening. Pneumatic Otoscopy Pneumatic otoscopy is completed by hand sealing the ear canal around the speculum tip of an otoscope. The ear canal and TM are then visualized prior to and while positive and negative air pressure are directed into the ear canal. Pneumatic otoscopy permits direct visualization of the TM color, position, appearance, landmarks, and mobility, and sometimes visualization of fluid in the middle ear cavity.

20 9 A common criticism of using pneumatic otoscopy to diagnose OM concerns the validity and reliability of the otoscopist. This occurs because pneumatic otoscopy requires a subjective evaluation of the static and dynamic status of the TM. The skill and experience of the otoscopist is therefore highly relevant. One way to evaluate the effectiveness of an otoscopist s findings is to perform a myringotomy and tympanocentesis immediately after pneumatic otoscopy. Another way is to compare the otoscopist s observations against another otoscopist or physician for the same ear. Nozza, Bluestone, Kardatzke, & Bachman (1994) reported a disagreement rate of 21% between the diagnoses of OM using pneumatic otoscopy compared with the actual presence of middle ear fluid determined by myringotomy. It appears that accurate OM diagnosis using pneumatic otoscopy increases as the skill and experience of the otoscopist increases. Another problem with pneumatic otoscopy is that the amount of air pressure applied to the TM is highly variable. Cavanaugh (1989) reported air pressure variations that ranged between 338 and 1134 dapa while examining 53 infants, children, and adolescents. He questioned the reliability of pneumatic otoscopy mobility measures due to these large air pressure variations. Pneumatic otoscopy can often be difficult to obtain on a child due to the small size of the child s ear canal, the difficulty in obtaining a hermetic seal, or simply because of a lack of cooperation. Without proper insertion of the speculum into the ear canal, visualization of the TM cannot be obtained. Without a complete hermetic seal of the speculum with the walls of the ear canal, positive and negative pressure cannot be obtained to mobilize the TM. Lack of TM mobility was one of the prime indicators of middle ear dysfunction. Further, fluid often persists behind the TM and cannot be readily visualized, only detected due to the immobility of the TM. Kaleida (1997) reported that the diagnostic accuracy of pneumatic otoscopy can be improved using a descriptive classification system called COMPLETES (Kaleida, 1997). COMPLETES is a mnemonic for color, other conditions, mobility, position, lighting, entire surface, translucency, external auditory canal, and seal. The mnemonic was created to remind practitioners of the essentials that should be included when using pneumatic otoscopy to diagnose conditions of the ear canal, TM, and middle ear.

21 10 Even though the use of pneumatic otoscopy to diagnose OM has been criticized, a recent report suggests that pneumatic otoscopy can have a high sensitivity regarding the diagnosis of OM. Takata et al., (2003) reported that pneumatic otoscopy was 94% sensitive and 80% specific in a meta-analysis of OM research. However, they noted the variability between studies, which may be related to the sample age differences and the experience of the otoscopists (Takata et al., 2003). Tympanometry Tympanometry is an objective measure of middle ear function. It uses an electroacoustic immittance meter to estimate middle ear air pressure and the mobility of the TM and the structures of the middle ear system. Acoustic immittance is a general term used to describe the aspects of acoustic impedance and admittance, meaning the opposition to or ease of sound flow through the middle ear system. The results of tympanometry are a graphic display called a tympanogram that shows the mobility of the TM and middle ear structures as a function of air pressure in the ear canal. Tympanometry is completed with a pneumatic pump that controls air pressure in the ear canal after the ear canal is hermetically sealed with a probe tip. Typically, the air pressure is varied around the ambient pressure from 200 to -400 dapa while a 226-Hz probe tone is presented. The positive pressure of 200 dapa causes the TM to become tense, allowing for a measurement of the ear canal volume (ECV) cm 3. As the pressure decreases from 200 to -400 dapa, several other measures can be made, including the point of maximum TM mobility or the Peak of the tympanogram. This point of maximum TM mobility is called Peak Pressure (PP) and is quantified in dapa. Another measure derived from a tympanogram is the peak compliance (PC). PC is the difference in Immittance from the peak of the tympanogram minus the Immittance at 200 dapa of air pressure. PC is quantified in cm 3. The final derived tympanogram measure, tympanic width TW), is used to quantify the flatness of the tympanogram. Specifically, TW is

22 11 the width (in dapa) of the tympanogram measured at 50% of the PC value. Examples of normal tympanograms showing these derived values are illustrated in Figures 1.1 to 1.5. The resulting tympanogram can be objectively compared with normative data and with criteria that have been suggested for the diagnosis of OM. Several studies have shown that tympanometry is a valid and reliable measure of middle ear function when compared with the findings of myringotomy (Ben- David, Podoshin, & Fradis, 1981; Babonis, Weir, & Kelly, 1991; Nozza, Bluestone, Kardatzke, & Bachman, 1994). When no middle ear pathology is present, the tympanogram indicates normal middle ear function where the PP typically occurs around the atmospheric air pressure (0 dapa) and the measures of PC, ECV, and TW are within normal limits [Figure 1.1 is an example of a normal tympanogram]. However if a pathology such as OM causes the middle ear system to become stiff, the resulting tympanogram will typically appear to be flat, as illustrated in Figure 1.6. Flat tympanograms with normal ECV are typically due to OM, but can be associated with other pathologies such as cholesteatoma or stapes fixation. Measures of PP are typically very negative or immeasurable, PC is generally very low, and TW is generally very large or immeasurable when OM is present. OM does not affect measures of ECV. However, a flat tympanogram with abnormally large ECV is typically indicative of a perforation in the TM. Another common tympanogram shape occurs when TM mobility may appear normal but the PP occurs at a negative pressure (generally at a pressure less than -100 dapa). This type of tympanogram is generally associated with Eustachian tube disorders. An example of this type of tympanogram is illustrated in Figure 1.7. The ASHA guidelines (ASHA, 1997) for detecting a middle ear disorder include a tympanogram having a TW >150 dapa and a PC <0.2 cm³. Using these guidelines, Nozza et al. (1994) found that these measures have a sensitivity of 95% and specificity of 25% compared with myringotomy findings. The lack of specificity using the ASHA guidelines is a potential problem, since it may result in a very high over-referral rate. The AAA guidelines (AAA, 1997) recommend a TW criterion >250 dapa and/or PC <0.2 cm³ for rescreening or medical referral if the child also

23 12 had ear pain, otorrhea, signs of disease, flat tympanograms, or a large ear canal volume not due to pressure equalization tubes. Recall, Nozza et al. (1994) compared the use of pneumatic otoscopy and tympanometry to myringotomy where the pneumatic otoscopy and tympanometry measures were made immediately before a myringotomy was performed. Pneumatic otoscopy had good sensitivity (85%) but only fair specificity (71%) (Nozza et al., 1994). More importantly, the pneumatic otoscopy results disagreed with myringotomy results more than 21% of the time (Nozza et al., 1994). Various tympanometry measures were also evaluated against myringotomy findings. Using different criterion levels, Nozza et al. (1994) determined that a TW >300 dapa or a PC <0.1 cm³ had the highest sensitivity (80%) and specificity (82%). Statistical analysis did not suggest a strong correlation between TW and PC, meaning their use together did not provide a better ability than used individually to diagnose the presence of OM with effusion. Interestingly, combining otoscopy with TW measures did not improve the sensitivity but did improve the specificity when compared with the myringotomy results. Further, the majority of data available for pass/fail criteria for tympanometry was based on children over 3 years of age (Margolis & Hunter, 1999). Roland et al. (1989) used tympanometry and pneumatic otoscopy in their assessment of the incidence and duration of OM. Although this study did not compare tympanometry and pneumatic otoscopy results with myringotomy, statistical analysis revealed that both procedures provided similar information compared with hearing thresholds obtained with auditory brainstem response (ABR) testing. The results were also interpreted to suggest that OM could be diagnosed if a flat tympanogram was present without the need for otoscopic examination (Roland et al., 1989). Roush, Bryant, Mundy, Zeisel, and Roberts (1995), evaluated the longitudinal changes in SC and TW measures in children with and without OM diagnosed by pneumatic otoscopy. Sixteen hundred separate assessments were made on 88 children during a 24-month period. Overall, significant age effects were found. Normal PC values ranged from 0.2 to 0.5 cm³ at 6-12 months to 0.3 to 0.8 cm³ at months. TW measurements also changed with child age. At the ages of 6-12 months, TW measurements ranged from dapa, while decreasing to 92-