Discussion
AOM, upper respiratory tract infections, pain
OTITIS MEDIA WITH EFFUSION, UPPER RESPIRATORY TRACT INFECTIONS, DISEASE, RECRUITMENT, OTITIS MEDIA, VIRAL UPPER RESPIRATORY TRACT INFECTIONS
We examined symptoms associated with AOM and compared the performance of two AOM symptom scales during a community based RCT with Aboriginal and Torres Strait Islander children living in urban settings in Australia. Neither scale had been previously used as research tools in this population. In planning the RCT, we thought the simplicity of the pictorial AOM-FS may assist in data collection yet provide useful symptom data, as compared to the more commonly used AOM-SOS. We found that the AOM-FS, although not primarily designed as a research scale, was comparable to the AOM-SOS in terms of completeness of data, correlation and linear trends. However, our findings challenge the usefulness of both the scales in this and other otitis media research with Aboriginal and Torres Strait Islander children. A substantial number of children had no or minimal symptoms at the time they were diagnosed with AOM, and there was a trend of decreasing symptoms over 2 weeks, regardless of whether children’s AOM had resolved by day 7 or not according to stringent AOM diagnostic criteria. This could be due to the scores in the AOM-SOS and AOM-FS at baseline both reflecting upper respiratory tract infections rather than AOM symptoms.Research and clinical management of AOM is complicated by the fact that different diagnostic criteria for AOM may be applied internationally [More than a third of the children with AOM in the WATCH trial had no or minimal symptoms at the time of recruitment as scored by both the AOM-SOS and AOM-FS scales. It is known that otitis media with effusion is commonly asymptomatic as per parental report [It is known that AOM is usually associated with viral upper respiratory tract infections [Our participants, at a median age of 3.5 years, were older than most of the children involved in testing and research use of the AOM-SOS and AOM-FS, who were largely under 24 months [One-item symptom scales like the AOM-FS have been little used in research and it can be difficult to know what such scales are measuring. Faces scales are preferred by respondents when given a choice in assessing pain in children [The study has some limitations. The criteria we used for the diagnosis of AOM, namely tympanic membrane bulge and/or ear pain, determined our participant group and our study must be interpreted accordingly. Furthermore, it is possible that GPs did not recruit highly symptomatic children into the WATCH trial, preferring to prescribe antibiotics outside guideline recommendations. The relatively large proportion of children in our study who had limited symptoms at baseline affected how the scales functioned. We did not have enough participants with high symptom scores to be able to assess whether the symptom scales are more useful in that subpopulation. Other potential limitations are the correlation of two scales with differently defined time capture and the administration at some study points by phone, which is likely to have changed their functioning. This particularly applied to the AOM-FS, given that it is likely carers did not always refer to the faces image in scoring their child’s symptoms over the phone.We note that the AOM-SOS was not designed to discriminate between those with AOM and those without, but to follow the course of the disease according to score changes compared by treatment groups at designated time points [