ISDR
ISDR RCT: Patient Information
ISDR RCT: Patient Information
When you arrive for your screening appointment you will be met by a researcher who will answer any questions you may have after reading this leaflet. If you agree to take part in the trial we will ask you to sign a consent form.
To compare the results of a personalised risk based approach and annual screening we will divide trial participants into two groups. Group 1 will continue to receive annual photographic screening as usual. Participants in Group 2 will have their personalised screening interval determined using risk factors from past screening data and medical information, including type of diabetes, blood pressure, and diabetes control. According to their individual risk participants in this group will be screened every 6 months, every 12 months or every 2 years.
You will be randomly assigned to one of the two groups by a computer. Neither you nor your doctor can choose which one you are put into.
We aim to write to you within six weeks of your screening visit to let you know your results, which group you have been assigned to (annual or personalised screening interval) and when your next screening appointment will be. Rarely there may be a delay and if this is the case we will contact you to explain what is happening.
If you are in the personalised screening interval your risk will be assessed each time you attend for screening. If your risk has been reduced (because your diabetes is under better control) you may be screened at a longer interval. If your risk has worsened (due to poorer control) you may be screened more frequently.
At your screening visit we may also ask you to complete two short questionnaires on:
This whole process will take around 20 minutes during your first screening visit.
If you are asked to complete the questionnaires at Baseline, you will be provided with the same general state of health questionnaire each time you attend for screening. This will take around 8 minutes to complete.
You will be taken out of the trial if when we examine (grade) your photographs you have any eye changes that need referral to the Hospital Eye Service. These may be diabetic changes, or it may be that we have not obtained clear enough photographs of your eyes to grade them for diabetic retinopathy (this is usually due to early cataract or small pupils). If you have consented to the trial we may send you a copy of the health questionnaire to complete in your own time at home in the future.
Towards the end of the trial we may ask you about your experience and for your opinion on the trial.
It is not possible to tell you whether you are likely to benefit from entering the trial or not. Results produced from this trial will be used to improve eye care for people with diabetes in the future.
Expected benefits associated with personalised risk based screening are that people with diabetes will feel reassured that their own personal risk is being determined. This may reduce anxiety associated with screening. For participants who are at low risk of developing sight-threatening diabetic retinopathy there will be fewer screening appointments.
For participants who are at risk of developing sight-threatening diabetic retinopathy there may be earlier detection of their eye disease, and therefore better outcomes in terms of vision and a need for less treatment
If you are in the 2 yearly screening group (i.e. in the low risk group) it is possible that your diabetic retinopathy may be detected later than would have been the case with fixed annual screening intervals.
The consequence of this may be that treatment might be needed immediately (normally there is a reasonable period of time between needing referral to the Hospital Eye Service and needing treatment). More treatment might be needed than would have been the case if your diabetic retinopathy had been detected earlier or treatment might be less successful.
We believe the risk of this happening to be very low as your risk will be determined using your personal data.
You do not have to take part if you do not want to. If you choose not to take part in this trial you do not have to give a reason. If you do not take part it will not affect the standard of health care you will receive now or in the future and you will continue to be screened annually as usual. Please ask any questions if you are unsure about anything.
You are free to change your mind and withdraw from the trial any time without giving a reason.
If you wish to withdraw consent from the trial, we will destroy all your identifiable information. Other information collected from you up to the time of withdrawal will be included in the study results unless you do not wish it to.
Any information you give us will be kept in strict accordance with the Data Protection Act 2018 and under the protection of Caldicott Guardians.
Personal information that could identify you such as your NHS number and date of birth will be used for the following purposes:
The above list of uses is not exhaustive (e.g. “include but are not limited to”).