FAQs

Taking part in research is completely voluntary. STOP-ACEi participants can decline any research assessments or refuse to continue sharing their data for any reason, and at any point during trial follow-up.  But wherever possible, we want to collect as much of the trial outcome data as we can so the patient’s participation can be used to improve future patient care.

There are different types of withdrawal for STOP-ACEi. So if a STOP-ACEi participant asks to withdraw from the trial, please clarify which aspects they want to withdraw from. Usually, patients that withdraw want to stop coming in for trial-specific visits, or want to opt out of specific research assessments (e.g. the walk test or the questionnaire), but are happy to continue sharing their data. It is essential to make a clear record of this discussion with the patient so it is clear what consent still stands, and what has been withdrawn.

Lots of the data we collect for STOP-ACEi are available from routine clinical monitoring (e.g. blood results, blood pressure, etc.), so if the patient wants to withdraw from full trial follow-up, but is happy to let us continue receiving these data, please continue with the patient’s data collection based on their medical records. At each follow-up time point, complete what you can of the CRF from the patient’s case notes.

To minimise queries, make it clear which data are missing in the notes section of the CRF. For example, ‘Patient withdrawn from full follow-up. Available data reported from clinical records, but the following data are missing: walk test, alkaline phosphatase, uPCR/ACR, weight’.

The use (or not) of ACEi/ARBs is at the treating clinician’s discretion for patients that have withdrawn from trial follow-up. 

Yes. Lots of the data we collect for STOP-ACEi are available from routine clinical monitoring (e.g. blood results, blood pressure, etc.). It is fine to use these to complete the CRF. It is better to report what you can, rather than miss a visit altogether. However, there are few things to be careful of:

• Make a record of the reason for any Protocol deviations. For example, if assessments have been missed, or any visit assessments are outside the permitted visit window, make a record of the reason. For example, ‘uPCR result taken from last clinic on [date], which is out of the visit window, as patient declined repeat test on day of research visit’.
• We recommend that you make a record to make it clear what is the source data for the trial visit, especially if this is pieced together from multiple sources.
• When you input the data on the eCRF, it helps to minimise queries if you clearly explain what data are missing and why in the ‘notes’ field. For example, ‘The following assessments were not done as the participant did not attend research clinic due to transport issue – walk test, ECG, uPCR/ACR. Other data are taken from medical records and clinic appointment of xxxx date’.

The visit schedule forms part of the Protocol for the STOP-ACEi trial, so a record should be made (including the reason) if there is a deviation from the schedule. At the same time, all aspects of research are voluntary, so the participant is free to decline any assessments or additional visits. The visit schedule for STOP-ACEi was designed to fit in with the normal clinic follow-up frequency for patients with advanced kidney disease, but this might not always coincide, for example if the clinic follow-up schedule is altered following an admission, or the patient requires more/less frequent follow-up than the general advanced CKD population. You should always aim to see the patient within the permitted visit window, but if this is not possible or the patient declines to attend, it is better to obtain the trial data late than not at all.

If the participant is not seen within 6 weeks of a visit due date (i.e. a visit is nearer to the next trial due date), the time point has been missed. If this happens, please let us know, and make a record of the deviation and the reason. 

Yes, if a participant is unable to complete the 6 minute walk test they are still able to continue their participation in the STOP-ACEi trial. A reasonable effort should be made to perform the test for all participants. However, if the responsible clinician feels the test is inappropriate or unsafe for any particular participants, the decision to perform the test is at their discretion.

Where the form asks “Has the participant started renal replacement therapy?” this refers to long term/permanent treatment so you should still answer ’no’. Please record any related adverse events (e.g. AKI) or hospital admissions in the AE and clinical visits sections of the CRF as normal. If there has been an SAE, you should also report this by fax using an SAE form within 24 hours of being notified of the event.