REAL-DERM is a real-world comparative study. This means it will compare NHS services as they work in practice, rather than testing DERM only in ideal or laboratory conditions.

The study will work with up to 16 NHS Trusts across England. This is expected to include up to eight NHS teams that use DERM and up to eight NHS teams that use other ways of assessing possible skin cancer.

The study will compare four NHS care pathway types:

• DERM autonomous pathway: DERM may directly support the next step in a patient’s care. If a skin lesion is assessed as low risk, the patient may be discharged. If it is assessed as higher risk, the patient may be referred for further assessment. “Autonomous” is the term used in the study protocol. It does not mean there is no NHS oversight, clinical pathway or safety process around the decision.
• DERM triage pathway: DERM may support a decision to discharge the patient or send the case for teledermatology review. Teledermatology means skin images and clinical information are reviewed remotely by a specialist or trained clinical team.
• Teledermatology standard care: skin images and clinical information are reviewed remotely by a specialist or trained clinical team, without DERM.
• Direct urgent referral standard care: patients are referred directly for urgent specialist assessment without DERM.

The study will use routine NHS patient information already collected during care. This may include referral information, appointments, diagnosis, treatment, follow-up and demographic information such as age, sex and ethnicity where available.

Real-world studies help show how technologies work in ordinary NHS services. They also need to take account of differences between NHS organisations, such as staffing, waiting times, patient populations, data recording and local ways of working. These factors will be considered when interpreting the findings.

The study will examine whether outcomes differ between patient groups, including people with different skin tones. It will be transparent about the strengths and limits of the available data, including where information is missing or where conclusions are less certain.

NHS patient information will be held and analysed through the Wessex Secure Data Environment, a secure NHS system used for approved research. Researchers using the study dataset never see information that directly identifies patients, such as names, addresses, or NHS numbers.

Public scrutiny is built into the study. The protocol and supporting materials were reviewed by the Wessex SDE Digital Critical Friends, an established group of patients, carers and members of the public who provide scrutiny on health data research. They endorsed the protocol and overall study direction, concluding that the study should be able to proceed as proposed. They also identified issues for the study team to address during study delivery, interpretation of findings and public reporting.

A dedicated REAL-DERM Public Advisory Group is being recruited to support the study. Alongside this, the study’s AI and Health Equity Lead will provide scrutiny of equity and public trust, including engagement with affected communities and other stakeholders. Together, these arrangements are intended to help ensure that the study is fair, transparent and publicly accountable throughout its delivery and reporting.

Trial Status:

The study is in set-up.

This means the study team is finalising the approvals, agreements and practical arrangements needed before NHS patient information can be used for the research. The study will only use NHS patient information once the required NHS research and confidentiality approvals are in place.

This page will be updated as the study progresses.

Population:

The study expects to include NHS patient information from at least 200,000 adults aged 18 or over who are seen by one of the NHS teams taking part in REAL-DERM because a mole, mark, lump or patch on their skin may need checking for possible cancer.

This is expected to include at least 100,000 from NHS pathways using DERM and at least 100,000 from non-AI pathways. This large study size is important because it helps researchers examine safety, accuracy and fairness with greater confidence.

Funder

This study is commissioned by NHS England and funded by the Office for Life Sciences.

It is delivered by Health Innovation Wessex, an organisation set up by NHS England to help the NHS and social care teams use technology and new ways of working to improve health and care. The national Health Innovation Network brings together the 15 regional health innovation networks across England. They help the NHS and social care to find, test, implement and scale innovations that improve patient outcomes, support a more productive workforce, and drive economic growth.

University Hospital Southampton NHS Foundation Trust is the study sponsor. This means it has overall responsibility for making sure the study is properly set up and managed.

Further Information

REAL-DERM will operate under approval by an NHS Research Ethics Committee. It is not seeking consent from individual patients to be part of the research study. Instead, it will be seeking approval to access NHS patient data through the Wessex Secure Data Environment.

The Wessex Secure Data Environment (Wessex SDE) is an NHS secure research system. Following advice from the Health Research Authority's Confidentiality Advisory Group, it has Section 251 support to enable approved research using NHS patient information where obtaining individual consent is not practical and there is a clear public benefit.

Patients and members of the public can choose whether their NHS information is used for research and planning. The National Data Opt-Out will apply to this study, and any applicable opt-outs will be respected before information is made available for research.

The study includes several layers of governance, public involvement and independent scrutiny. These are intended to help ensure that questions about safety, fairness, data quality, competing interests and interpretation of findings are identified and addressed throughout the study.

The DERM tool was developed by Skin Analytics, a healthcare technology company. The findings of the study will be analysed and reported independently by NHS and university researchers, with arrangements in place to declare and manage competing interests. Skin Analytics is not leading the study and will not decide how the findings are interpreted or reported.

The results will be shared with NHS England and NICE, the National Institute for Health and Care Excellence, and published so that patients, healthcare professionals, researchers and the public can learn from them.