Background

Disorders of the tympanic membrane (ear-drum) such as perforation, scarring, thinning and retraction are commonly found on routine ear examination in both symptomatic and asymptomatic patients. In many cases these conditions will have no long-term detrimental effects and some will resolve spontaneously. However, in many cases of retraction, progression will occur resulting in deafness, discharge from the ear and in some cases meningitis, intracranial infection and even death. It is not currently possible to identify which patients with retractions may run into problems and which ones will be stable or improve in the longer term. This means that many patients are followed up in clinic unnecessarily, whilst those that may benefit from closer surveillance, allowing timely intervention if progression of disease is seen, or early intervention as prophylaxis against disease development, are often not identified until damage has been done to the ear and hearing. In the meantime these patients may suffer with infection, discharge and intermittent or progressive deafness, often having significant lifestyle impact on top of the long-term risk to hearing and health. The ability to identify those patients at risk of complications would, potentially, have significant long-term health and lifestyle benefits.

Methods

As part of the focus group, 8,000 children from ALSPAC have undergone regular assessment of their hearing. At a previous assessment, 7,250 children had digital photographs taken of their eardrums showing thepars flacida(top of eardrum) andpars tensa(main part of ear drum); these have subsequently been analysed for the presence of abnormalities as shown below:

Area

No retraction

Retraction

Moderate / Severe disease

Pars Flacida

13,704

558

271

Pars Tensa

13,918

444

113

In the first instance the group of children identified as having a moderate / severe retraction will be invited for a clinical review with repeat photographs of the eardrum taken. A cohort from the group previously identified as normal will be assessed in the same clinics.Ethical approval will be obtained from ALSPAC and from the local regional ethical committee. Appropriate information sheets will be provided with the initial invitation to attend and consent forms completed at the time of review.

The letters would be sent by ALSPAC, replies would collected by ALSPAC, and only those that confirm their desire to participate will have their details supplied to the research team. The research team would then use NHS resources to book appointments.

Transport costs will be paid and a voucher offered as an incentive to attend. Review will be undertaken in the ENT department at St Michael's Hospital by one if the investigating team, either in a regular ENT clinic or a specific research clinic; if it is more convenient for those invited, clinics will be undertaken at a peripheral site, e.g. Weston General Hospital, assuming local approval. If possible we would like to identify some children of interest who are part of the ALSPAC cohort and are already due for ENT assessment or review to act as a pilot study. We would aim to do this by obtaining consent from patients seen in the clinic, who may be part of the relevant focus group, to contact ALSPAC to see if data is held on them. Since the children would have already been reviewed and appropriate clinical information obtained, costs would be kept to a minimum. If this approach is unsuccessful, we would seek ethical approval to obtain the NHS Numbers from ALSPAC of the young people identified previously, and attempt to match those with young people already booked for ENT examination in one of the main hospitals. A pilot study would allow us to fine-tune our study and subsequently apply for substantial funding for the review of the remaining children

If significant disease is identified at review, the child's GP will be contacted to arrange further assessment.

AnalysisDigital photographs will be analysed and classified in the same way as the original images. Comparison will be made between individuals with regard to whether the previously documented retraction has progressed, stayed the same or improved. ALSPAC data will be analysed to identify potential risk factors for disease progression.

This study will eventually describe changes in retraction pockets in a cohort of approximately four hundred patients over a six-year period. It will identify three possible outcomes: improved, stable or progressed. Identifying changes in these patients will allow appropriate clinical follow up if not already arranged and will identify a cohort of patients suitable for further analysis of a variety of potential risk factors, including environmental and genetic