Patient information leaflet

What is the SAFE-STONES study?

After treatment for kidney or urinary stones, people are usually followed up with scheduled clinic appointments and scans, often for years. Many of these appointments happen when people feel completely well. SAFE-STONES is a research study comparing two ways of doing follow-up:

• Patient-initiated follow-up (PIFU) — you get in touch when you have symptoms or concerns, using this website or by phone, and are seen quickly when you need it.
• Standard follow-up — fixed appointments and scans arranged by the hospital in the usual way.

The study is testing whether patient-initiated follow-up is just as safe as standard follow-up, so that in future people can be offered the type of follow-up that suits them best.

Why have I been invited?

You may be invited if you are an adult who has recently completed treatment for a kidney or urinary stone at one of the hospitals taking part in the study.

Do I have to take part?

No. Taking part is entirely voluntary. If you decide not to take part, or you join and later change your mind, your usual NHS care will not be affected in any way. You can withdraw at any time without giving a reason.

What will happen if I take part?

• A computer will allocate you at random (like tossing a coin) to either patient-initiated or standard follow-up. Neither you nor your doctor chooses the group.
• If you are in the patient-initiated group, you will be shown how to use this website to report symptoms and request follow-up. A clinical team member reviews requests, and urgent reports alert a named clinician.
• If you are in the standard group, your appointments carry on being arranged by the hospital as usual.
• Everyone will be asked to complete two short questionnaires about their health and quality of life at set times — each takes a few minutes.
• Scans and blood tests happen when clinically needed in both groups.

The scans we use

Low-dose CT scan (CT KUB)

A low-radiation scan that shows whether any stones are present. This is the gold-standard (most accurate) test for kidney stones, so it is the scan we normally use.

Ultrasound

A scan using sound waves; it uses no radiation. We mainly use ultrasound in children and during pregnancy, where we avoid radiation. It is less reliable than CT for finding small stones, so it is not usually used for adults in this study.

What are the possible benefits and risks?

Patient-initiated follow-up may mean fewer unnecessary hospital visits and quicker access when you actually need help. The main possible risk is that a problem could be picked up later than it would have been at a scheduled visit — the study is designed to measure exactly this, and there are safety nets: urgent symptom reports alert a named clinician, and you can always contact your team or use 999/A&E.

What happens to my information?

We collect the minimum personal information needed to run the study safely (such as your initials, year of birth and NHS number), stored securely on NHS-approved systems in the UK and handled under UK data-protection law. Study results are reported in a way that does not identify you. If you withdraw, you can ask for your identifiable information to be removed; anonymised study data already used in analyses may be kept.

Read the full privacy notice

Trusted information about kidney stones

• NHS — Kidney stones
• BAUS — Kidney stones

These open external NHS / BAUS websites in your browser.

Questions or concerns

Study team: [contact name / phone / email] (during working hours). If you wish to complain or have concerns about how you have been approached or treated, contact [PALS / sponsor contact].

[Contacts, sponsor details, REC reference and version/date to be added before approval. Content to be reviewed with the patient/public involvement (PPI) group and checked for reading age.]