Validation of a portable tympanometer for use in primary care

doi:10.1016/0165-5876(94)90168-6

International Journal of Pediatric Otorhinolaryngology

Volume 29, Issue 3, June 1994, Pages 219-225

https://doi.org/10.1016/0165-5876(94)90168-6 Get rights and content

Abstract

Objective — to determine the accuracy of a handheld, portable tympanometer, the microtymp, in comparison with a reference instrument, the AR 85 tympanometer and with the gold standard: presence or absence of middle-ear fluid. Design — comparison of results from the microtymp with results from the reference tympanometer, the AR 85 and the gold standard. Setting — University Children's Hospital, Utrecht and the General Hospital, Overvecht, Utrecht. Subjects — 142 children (284 ears) aged between 6 months and 12 years, who were referred by their General Practitioner or Ear, Nose and Throat surgeon for myringotomy and/or tympanostomy tube insertion. Main outcome measures — tympanometry with the AR 85 and presence or absence of middle-ear fluid. Results — In 243 ears, of the included 284 ears, the test results of the microtymp were compared with those of the reference instrument, the AR 85 tympanometer. Sensitivity 0.96 (95% C.I., 0.93, 0.99), Specificity 0.81 (95% C.I.: 0.71, 0.91). In 233 ears, of the included 284 ears, the test results of the microtymp were compared with the gold standard. Sensitivity 0.94 (95% C.I.: 0.90, 0.98), specificity 0.48 (95% C.I.: 0.37, 0.59). Conclusion — The microtymp is a valid instrument for diagnosing middle-ear effusions. The results of the microtymp are highly comparable with traditional tympanometers: high sensitivity and much lower specificity. Use in primary care can increase diagnostic accuracy of otitis media with effusion (OME) and makes follow-up possible. This will help to discriminate between those OME cases who need further treatment and those who will resolve spontaneously.

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Cited by (24)

Comparison of old, professional and consumer model acoustic reflectometers in the detection of middle-ear fluid in children with recurrent acute otitis media or glue ear
2007, International Journal of Pediatric Otorhinolaryngology
Citation Excerpt :
Myringotomy, the gold standard method in identifying MEF, is invasive, and pneumatic otoscopy is considered to be technically difficult in primary care [2]. Tympanometry has generally proved to be equal to pneumatic otoscopy in terms of sensitivity and specificity in detecting MEF [3–6] but has the disadvantage of requiring hermetic seal in the ear canal. Thus, its reliability is greatly affected by the co-operation of the child [3].
Acoustic reflectometry is an alternative method of determining the probability of middle-ear fluid. Its sensitivity and specificity are comparable to those of pneumatic otoscopy and tympanometry. The relative superiority between the first-generation model and second-generation spectral gradient acoustic reflectometers (introduced for both professional and consumer use) has not been studied. This study aimed to assess the diagnostic performance of three different acoustic reflectometry devices, and to evaluate the intercorrelation of the results.
Fifty children (100 ears) aged <7 years undergoing ambulatory otomicroscopic myringotomy in anesthesia were examined with three different acoustic reflectometers, and the results were compared to the myringotomy findings (gold standard method). Specificity, sensitivity and positive and negative predictive values of each instrument in detecting middle-ear fluid were determined. The intercorrelations between the three devices were assessed descriptively (percentage agreement) and statistically (kappa correlation).
Second-generation professional and consumer spectral gradient acoustic reflectometers performed equally well in detecting middle-ear fluid (specificities 84 and 85%, sensitivities 83 and 77%, respectively) and were superior to the old model. Accordingly, the results obtained with professional and consumer models correlated well with each other (kappa 0.60) but not with those of the first-generation device. Acoustic reflectometry is not reliable when performed in anesthesia with the patient lying down.
Newer spectral gradient acoustic reflectometers perform better than the older first-generation model. In this study, the consumer model gave the same information as professional model, but its diagnostic validity in the hands of layman consumers needs to be confirmed.
Tympanometry by nurses-Can allocation of tasks be optimised?
2007, International Journal of Pediatric Otorhinolaryngology
Citation Excerpt :
In primary care, ear canals may be substantially blocked by wax in 30% of children [14,15]. The tympanometry in our study is a little more complex than the minitympanometry used in some previous works [11,16]. With GSI 38 Auto Tymp, it requires a few seconds to print the tympanogram, which may have led to impatience and repetitious pressing of the buttons on the device.
Acute otitis media and secretory otitis media are the most common pediatric infectious disease with a substantial impact on especially primary health care. If nurses could perform and interpret tympanometries, family practitioners workload could be reduced. We wanted to investigate the ability of nurses to perform tympanometry and evaluate the amount of training required.
Prospective study comparing results from tympanometry with results at myringotomy at a University Central Hospital was conducted. Nurses at the Paediatric Ear, Nose, and Throat Department performed tympanometry prior to myringotomy. Sensitivity and specificity of tympanometries versus myringotomy were calculated. Nurses’ opinions about tympanometry and training required were evaluated.
During a 1-year period, 199 children were enrolled in the study and 392 tympanograms were analyzed. Sensitivity of tympanograms to detect middle-ear fluid was 0.54, and specificity 0.82. Secretion occurred in 22.5% of children with type A curves and 45.3% of those with type C curves. Nurses evaluated their training in tympanometry as adequate.
A single training session in tympanometry is inadequate to qualify nurses to perform tympanometry independently. Thorough research and testing to evaluate the quality of such training is required to produce reliable tympanograms.
Negative pressure tympanograms in children less than 2 years of age-different bacterial findings in otitis media by tympanometric results
2001, International Journal of Pediatric Otorhinolaryngology
Objective: The interpretation of negative pressure tympanograms as indicators of the presence of middle ear fluid has been ambiguous. Our purpose was to assess the occurrence and implications of negative pressure tympanograms and to study their association with bacterial pathogens in otitis media. Methods: Altogether 329 infants were enrolled at a well-baby clinic for the Finnish Otitis Media Cohort Study, a longitudinal prospective cohort study. The children were closely followed in a special study clinic from 2 to 24 months of age for respiratory diseases, especially acute otitis media. Children were examined at the study clinic with tympanometry and pneumatic otoscopy whenever visiting the study clinic for respiratory disease. Myringotomy with aspiration was performed if middle ear fluid was suspected in otoscopy. Occurrence of middle ear fluid in ears with negative pressure tympanograms (less than −100 daPa) was assessed. Nested case control design matched by visit type (acute or follow-up visit) and month of visit was used for analysis of association of bacterial pathogens and tympanometric results. Results: Middle ear fluid was encountered in 15% of ears with negative tympanometric peak pressure, a lower proportion than described previously. In otitis media with a negative tympanometric peak pressure, 71% of bacterial cultures remained negative for the main pathogens, compared to 36% in matched controls (P<0.001). Especially Streptococcus pneumoniae but also Haemophilus influenzae were rarely found in samples from negative pressure ears. Moraxella catarrhalis was equally often found. Conclusions: Negative pressure tympanogram is a poor indicator for the presence of middle ear fluid. Furthermore, if otitis media is diagnosed with negative tympanometric peak pressure negative middle ear bacterial culture for the main pathogens is highly probable. Expectant follow-up might be more appropriate than routine antibiotic treatment.
Diagnostic value of tympanometry in infants in clinical practice
1999, International Journal of Pediatric Otorhinolaryngology
One hundred and twenty-one visits of 58 infants (2–11 months of age) were evaluated in the Finnish Otitis Media Vaccine Trial. Infants were examined with tympanometry (Grason-Stadler GSI 38 Autotymp) and pneumatic otoscopy by one study doctor. Diagnosis of otitis media was verified by myringotomy in 74% of cases. Tympanometry was technically successful in 94% of ears. The success rate was statistically significantly higher (P<0.05) among infants less than 7 months of age than those above 7 months. The sensitivity of tympanometry (type B) to detect ears with middle ear fluid was 0.70 and the specificity 0.98 with a positive predictive value of 0.93 and negative predictive value of 0.94. The sensitivity was somewhat lower in the younger age group (0.61); specificity and positive and negative predictive values were good in both age groups. The high success rate and high negative and positive predictive values of tympanometry make it a useful aid for assuring the correct diagnosis of otitis media in infants in routine clinical practice.
Tympanometry by general practitioners: Reliable?
1999, International Journal of Pediatric Otorhinolaryngology
Background: The diagnosis of otitis media with effusion (OME) is difficult using only medical history and otoscopy. Tympanometry may, therefore, be helpful in the diagnosis and follow-up of OME in general practice. Studies regarding the reliability of tympanogram production and validation of tympanogram outcome have been performed. Objective: To gain insight into the usability of microtympanometry and the degree of agreement and accuracy of tympanogram classification in general practice. Methods: Data were collected in the offices of 49 general practitioners (GP’s). The usability of the microtymp was monitored against a checklist. GP’s (39) classified 47 tympanograms according to Jerger’s modified classification, designating them as ‘OME’, ‘no OME’ or ‘interpretion impossible’. The gold standard was the consensus over the 47 tympanograms reached by three doctors very experienced in tympanometry. Results: Of the general practitioners, 61% handled the microtymp faultlessly. The overall inter-observer agreement was moderate to substantial; with respect to the gold standard 74% of the general practitioners had a satisfactory to almost perfect agreement. These results were achieved after instruction and training; longer practice produced no significant improvement in the agreement. Conclusion: After training and instruction microtympanometry is a reliable diagnostic instrument in general practice. The classification of tympanograms is satisfactory. Classification problems arise when the curve is not a good one. Additional criteria for the assessment of the curves are proposed.
Minitympanometry in detecting middle ear fluid
1997, Journal of Pediatrics
To assess the time needed to perform rympanometry, the success rate and the importance of the child's cooperation for the accuracy of minitympanometry in detecting middle ear fluid, and the relation between the static admittance of the tympanogram and the weight of the middle ear fluid.
Two series of patients were enrolled. The first consisted of 206 consecutivechildren (mean age 4.7 years, range 1 month to 16 years) from the Outpatient Emergency Department of Pediatrics in the University of Oulu; the second group consisted of 162 children (age range 7 months to 8 years) who were referred to the Department of Otolaryngology for adenoidectomy, tympanostomy, or both procedures. In the first series the success rate and the time needed to complete a minitympanometric examination on each ear were recorded. In the second series, the tympanograms were evaluated according to the cooperation of the children at the time of the tympanometric examination, and the weight of the middle ear fluid was measured and compared with the static admittance of the minitympanometric curve. Sensitivity and specificity values were calculated separately for cooperative and uncooperative patients.
In the first series, the mean time needed for tympanometry was 2.1 minutes (range 0.5 to 10 minutes), and 179 (86.9%) of the patients were cooperative. In the second series, the sensitivity and specificity calculated for tympanometry in detecting middle ear fluid were 79% and 93% among the cooperative children. In the uncooperative group, sensitivity and specificity were 71% and 38%, respectively. The weight of the middle ear fluid varied from 5mg to 695mg. There was a significant negative correlation (r = -0.66, p < 0.001) between the static admittance in minirympanometry and the weight of the middle ear fluid.
Minirympanometry can be done quickly, it fails rarely, and in cooperativepatients it is a better tool than has been earlier suggested, but it is useless in uncooperative children. The amount of middle ear fluid varies notably even among young children.

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Research reportValidation of a portable tympanometer for use in primary care

Abstract

Int. J. Pediatr. Otorhinolaryngol.

Lancet

Glue ear guidlines: time to act on the evidence

Lancet

Impedance tympanometry and acoustic reflectrometry at myringotomy

Pediatrics

Design factors in the characterization and identification of otitis media and certain related conditions

Anal. Otol. Rhinol. Laryngol.

Otitis media with effusion: is medical management an option?

J. R. Coll. Gen. Pract.

Identification of otitis media with effusion

Ann. Otol. Rhinol. Laryngol.

Algorythm for diagnosis of otitis media with effusion

Ann. Otol. Rhinol. Laryngol.

Otitis media with effusion in preschool children

Laryngoscope

Otitis Media with Effusion in Children: The Dunedin Study

Anaesthesia and tympanometry

Internat. J. Ped. Otolaryngol.

Effective Health Care. The Treatment of Persistent Glue Ear in Children

Tympanometry and secretory otitis media. Observations on diagnosis, epidemiology, treatment and prevention in prospective cohort studies of three-year-old children

Acta. Oto. Laryngol.

Clinical Epidemiology: The Architecture of Clinical Research

The effects of anesthesia on middle-ear effusions

Laryngoscope

Effect of anesthetic gases on middle-ear pressure in the presence of effusion

Ann. Otol.

Predictive value of tympanometry in middle-ear effusion

Ann. Otol. Rhinol. Laryngol.

Monitoring middle-ear pressure by tympanometry

Acta. Otolaryngol. (Stockh.)

Clinical experience with impedance audiometry

Arch. Otolaryngol.

Research report
Validation of a portable tympanometer for use in primary care