Does an audiologist require GCP certification:
If the Audiologist is performing their normal duties (standard care) and NOT performing any trial related assessments, e.g. completing any trial related documents/databases/reporting etc. then they do not need a GCP certificate.
Anyone performing the AB words test is asked to complete trial training for completion of this assessment (a 9 minute video plus self-certification), but no further research training is required if this is the extent of a person’s involvement. Please see e-training link: STARFISH e-training link
Does an audiologist need to be on the Delegation Log:
If the Audiologist is performing their normal duties (standard care) and NOT performing any trial specific assessments, or completing any trial related documents/databases etc. then they do not need to be on the Delegation Log.
Can audiology students/apprentices can take part in this trial:
Students can be involved with audiometry, this one of the first competencies they acquire, so this should not be an issue. They may be less familiar with speech audiometry, hence they need to read the protocol and follow the guidance under supervision.
Do audiologists using AB word testing in standard care require additional training for the study:
Yes, there is trial-specific training for the AB word testing, which comprises of a 9 minute training video and self-certification of having completed this. Please see e-training link: STARFISH e-training link
Does the baseline AB word testing have to be done on the day of randomisation:
AB word testing does not have to be performed prior to randomising the patient. The assessment can be performed within 48 hours of randomisation and the treatment can commence in the meantime. This would allow for randomising at the weekends or if there were no Audiologist in the department on the day of randomisation and then patients can come back in a Monday or Tuesday, for the first one or another department can do the test. The trial requires a functional measure of speech and the AB word testing is the most widely used one in the UK at the moment.
Can a non-audiologist who is trained and had been allocated these responsibilities on the Delegation Log complete the AB word tests:
It should to be an audiologist or associate audiologist who completes hearing assessments, so we are certain of their competency with PTA and AB word testing.
Regarding audiologist blinding is this mandatory:
This is preferable, but not mandatory. If some of the smaller sites only have one audiologist working any day or audiology may be at a different site to ENT. It is preferable that the patient is not seen by the same person for the follow-up at the point they are being recorded for outcomes that performed the injections.
Regarding audiologist blinding; does this mean audiology staff are not able to perform the otoscopy:
The trial protocol is quite flexible regarding this. Where possible, an ENT clinician or another audiologist should perform otoscopy and confirm it is appropriate for the audiologist to test before the hearing testing at 6 and 12 weeks, to avoid the testing audiologist seeing evidence of injection. However, this is not an absolute requirement if this is not possible.
AB word tests are not standard of care at our site:
As per the protocol, AB word testing (and pure tone audiograms) are required as research assessments, as they inform the secondary outcome analysis for the STARFISH trial. We appreciate this test might not be delivered as part of standard care at all sites, however training on how to perform the AB words test is available.
Does the AB word testing have to be performed at baseline:
As per the protocol, the AB word testing is required at baseline, as the audiology assessments inform key outcomes. Protocol states “recommended to be performed on same day as pure tone audiogram or if not practicable within the next working day”.
Is the AB word testing required for all arms of the trial:
The audiology assessments inform key outcome measures for the trial analysis so are all required for all arms of the trial as per the Protocol (at baseline, 6 weeks and 12 weeks).
Does the AB word testing have to be performed in a specific order:
No, there is no standardisation of specific word lists.
Would the short or long version of the AB word testing be required:
We would require the long version.
Are there any instructions on how to perform the AB word tests:
The speech test procedure can be found on page 38 of the Starfish protocol
If you feel you still require more advice our audiology advisors are happy to discuss further with you directly.
Rachel Knappett (Senior Audiologist, Cambridge University Hospitals NHS Foundation Trust) - rachel.knappett1@nhs.net
Dr Debi Vickers (Principal Research Associate, The University of Cambridge - dav1000@medschl.cam.ac.uk
Is it ok for the patient to wear or continue to wear hearing aids:
Yes, is it ok for the patient to wear or continue to wear hearing aids.
With regards to the eligibility criteria requirement of a sensorineural hearing loss of 30 dBHLs or greater occurring. If the patient has a normal hearing level of -10 dBHLs and then the sudden loss is -20 dBHLs, would this patient still be eligible for the trial?
Yes, because in total the patient has had a total hearing loss of 30 dBHLs or more.
Is the same equipment used to perform the PTA/AB word testing:
‘Usually’ yes, however some older equipment may not support AB word testing. Depending on the manufacturer (e.g. Interacoustics) AB wordlists have been included in their PC audiometers as standard for about the last 5-6 years.
What equipment is required to perform the PTA/AB word testing:
Either a PC audiometer or a standalone audiometer. No additional hardware is required (e.g. headphones).
Usually, audiometers are used to perform the PTAs and the AB word testing (either PC audiometer or a standalone audiometer). Depending on the manufacturer (e.g. Interacoustics) AB wordlists have been included in their PC audiometers as standard for about the last 5-6 years. A license would be required to access the speech testing material on older equipment, which would need to be purchased costing around:
- £400 for Interacoustics Affinity Compact equipment
- £220 for Natus Otosuite Astera equipment
This may be more difficult to obtain for standalone audiometers. You would not need any additional hardware (headphones etc.)
The AB word testing e-training video guide was recorded on a similar model, made by the same manufacturer, please see training link for guidance on using the kit: STARFISH e-training link
Will the Sponsor supply any equipment for the PTA/AB word testing:
No
Will the Sponsor purchase the license for the PTA/AB word testing:
No
Does the equipment require calibrating and do we need to provide certificates:
The equipment should have annual calibration, no extra calibration would be expected for trial purposes. Certificates would not need to be seen.
In addition, daily stage A checks should be performed in accordance with BSA recommended procedures. Again, no evidence of the checks are required.
Can an Audiologist participate in the NIHR Associate PI Scheme:
An Audiologist can participate in the NIHR Associate PI Scheme, however eligibility of the participants into the trial, prescribing and administering of the trial interventions should be confirmed and performed by a medically qualified doctor (in rare circumstances a specialist nurse who treats SSNHL can confirm eligibility).