Surgical Devices and Implants Patient Reported Outcome Measures (PROMs) – Trial patient leaflet

Patient Reported Outcome Measures or PROMs are aimed at capturing the results or outcome of a medical procedure from a patient point of view. A PROMs online questionnaire has been developed to ask patients about their health before and after a procedure. PROMs information and data is used to measure and improve the quality of healthcare services and allow us to understand the difference that healthcare interventions make to a patient’s quality of life.  

NHS Digital provides digital services for the NHS and social care, including the management and provision of information, data and IT systems for commissioners, analysts and clinicians in health and social care in England. We are an executive non-departmental public body, sponsored by the Department of Health and Social Care.

This PROMs collection will form part of the Surgical Devices and Implants Information System (SDIIS), which was developed to enable the national reporting of the use of any surgical device or implant. We are running a trial with a limited number of patients to test the online questionnaire and the collection process, prior to the development of a national PROMs for pelvic floor collection.

The PROMs data will help improve patient safety by making it easier and quicker to identify adverse outcomes with particular devices and implants, so that any issues can be investigated promptly. This will be done by comparing pre- and post-surgical device and implant outcomes to the outcomes of patients who have had alternative procedures where a surgical device or implant was not used and allow the effectiveness of a device or implant to be checked. The resulting findings will improve future treatment options for patients.

You can help us by participating in this trial, as your feedback will help us to improve the PROMs process prior to a national rollout.

The information you are being asked to submit includes:

• your NHS number
• your family name
• your first name
• your current postcode
• your date of birth
• pre- and post-operative outcome information submitted by you as part of the review of your care

You will be asked by your healthcare team if you wish to take part in this trial, which involves you completing two questionnaires: a new PROMs online questionnaire developed by NHS Digital and an Electronic Personal Assessment Questionnaire (ePAQ).  

Participation in this trial is voluntary, and you will need to agree to take part. Your consent will be sought to share your data, including your email address, with NHS Digital specifically for this trial.

NHS Digital will then create an online account for you on our web platform to complete the questionnaire. You will receive details of ‘how to sign’ into NHS Digital’s PROMs questionnaire platform where you will be asked to agree to your data being collected and analysed by NHS Digital and your healthcare team.

You will then be asked to complete either a pre- or post-procedure PROMS questionnaire.

For the purposes of this initial trial, you will receive an email from NHS Digital with details of ‘how to complete a survey’. The results of which will be used to enhance the PROMs service.

In addition to the PROMs questionnaire, you may be asked to complete and submit an ePAQ questionnaire by your healthcare team. These two questionnaires, cover different aspects of your historical condition, treatments, and outcomes, and together will provide a more comprehensive view of your condition, procedure, and care received.

You will receive a registration code to ePAQ and instructions on how to complete it as part of your welcome email. The data submitted from the ePAQ questionnaire will be visible to your clinical care team provider and NHS Digital will also receive a copy of your responses. The information collected will be used to produce statistics about the quality of healthcare services offered by different healthcare providers (hospitals). These statistics will be used to measure and improve the quality of healthcare services.

Participating in this trial will not affect the care you receive from your healthcare team.

This is voluntary; however, your help would be greatly appreciated and would help us improve the PROMs service when it is made available for all patients. If you do not wish to take part, you do not need to provide your email address or complete the questionnaire.

NHS Digital has been given a legal instruction to collect and analyse data about surgical devices and implants and associated patient reported outcomes measures.

This legal instruction is known as a direction, which we received from the Secretary of State for Health and Social Care, under section 254 of the Health and Social Care Act 2012. The direction is called the Surgical Devices and Implants Directions 2020. It provides the legal basis for NHS Digital to collect and process personal data.

Our basis for processing personal data related to health (special category data) is Article 9(2)(g). This is because the processing of the data is substantially in the public interest and in accordance with the law, for the purposes of NHS Digital exercising its statutory functions under the direction. It is substantially in the public interest to collect and use PROMs data as the aims are to improve patient safety and to improve future treatments. This processing is also permitted under paragraph 6 of Schedule 1 of the Data Protection Act 2018.

With your permission, your email address will be shared with NHS Digital only for the purposes explained in this leaflet relating to this trial. If you change your mind and no longer wish to participate, you can choose to not complete the questionnaire.

Yes, up to the point where the data is aggregated (non-identifiable), your personal details can be removed. For more information on what aggregate data is please see Recital 162 EU GDPR.

If you change your mind, you can email NHS Digital via [email protected].

Patient email addresses will only be used for this trial. Your email address is needed to create an account for you on NHS Digital’s web platform.

Once the trial is complete, your account details will be deleted, and your email address securely and permanently removed from our system. For more information, please see the published Transparency Notice for this Trial.

NHS Digital takes its responsibility for looking after information very seriously and we always process information about you securely and in line with UK data protection laws and the UK General Data Protection Regulation.

There are strict rules about who can access the personal data we process, and for what it can be used. Within NHS Digital, only a limited number of authorised staff will have access to your information.

More information on how we look after your health and care information

View the transparency information for the Surgical Devices and Implants System.