Patient Reported Outcome Measures (PROMs) Data Collection (Trial)

PROMs are used to measure and improve the quality of healthcare services and allow us to understand the difference that healthcare interventions make to your quality of life.

This PROMs data 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. Prior to the development of a national PROMs for pelvic floor data collection, we are running a trial with a limited number of patients to test the questionnaire and the collection process.

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. An alternative procedure refers to a surgical device or implant was not used and the comparison will allow the effectiveness of a device or implant to be checked. The resulting findings will improve future treatment options for patients.

Your personal data, including data related to your health will be collected if you have had a surgical device or implant for a medical condition or if you have had an alternative procedure carried out for the same condition, but which did not involve a surgical device or implant. This data will include:

• 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

To help us test the new PROMs questionnaire, the clinical team will ask, if you wish to take part in this trial. This will involve you completing two questionnaires: a new PROMs questionnaire developed by NHS Digital and an Electronic Personal Assessment Questionnaire (ePAQ).

Completion of 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.

Your NHS number will be checked and assured by NHS Digital's Master Person Service. This is to ensure we can correctly identify you and allow your PROMs data to be linked to you.

For the purpose of this trial, NHS Digital will link the collected PROMs data to other national datasets held by NHS Digital, including Hospital Episode Statistics (HES), Pelvic Floor Registry (PFR) and Master Person Service (MPS), to support the development of the analytical toolset. NHS Number and other Patient Identifiers will be used to complete this linkage.

For the purpose of this trial, there will be no publication of PROMs questionnaire data.

All data which is shared by NHS Digital is subject to robust rules relating to privacy, security, and confidentiality and only the minimum amount of data necessary to achieve the relevant health and social care purpose will ever be shared.

Wherever possible, de-personalised data or anonymous data is used and shared to protect patient confidentiality. We also apply the National Data Guardian's Caldicott Principles to ensure we only provide the minimum amount of data necessary for the purpose for which it is to be used.

Personally identifiable data can be shared for direct care, but this is always done in accordance with the law and subject to safeguards to ensure that the data is kept safe and secure.

• PROMs data is expected to be shared with organisations such as health care organisations and clinicians; the organisation that provided your care: to assess the effectiveness of your care, to improve the services they offer and, in the event, you need to be contacted about issues affecting your device that require follow-up action

PROMs data may be used for other purposes other than direct care, and used by commissioners of NHS services, research organisations, and the , and the Medicines and Healthcare products Regulatory Agency (MHRA), for example

• MHRA: to support the analysis of patient outcomes relating to surgical devices and implants to identify possible incidents requiring investigation alongside intelligence they receive through the Yellow Card Scheme
• NHS clinical commissioning organisations, Integrated Care Boards (ICBS) and other bodies which are responsible for arranging the provision of health services in England: to help plan and improve NHS healthcare services
• research organisations, including universities and charities: to carry out research

Details about the PROMs data shared with other organisations, except for anonymous data, are published in the NHS Digital Data Uses Register.

NHS Digital will keep PROMs data for the length of this trial which we expect to last for a maximum of a year. If you no longer wish for your data to be processed for the purpose of this trial, we will remove this within one month or advise why this is not possible. We may not be able to remove your data where this has already been used to create aggregated (non-identifiable) data.

At the end of the trial period, you will be contacted by NHS Digital to ask if you would like your PROMs information to be used for the purpose of monitoring patient outcomes. If you do not respond to this request, we will remove your information. We will provide you with the link to the updated Transparency Notice setting out how your data will be used going forward.

Your PROMS data will be stored and processed only within the United Kingdom (UK). 

We have been given a legal instruction to collect and analyse data about surgical devices and implants and associated patient reported outcomes.

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 use data for the purposes set out above. The scope of the surgical devices and implants data collected is set out in the requirements specification. 

Under the UK General Data Protection Regulation (GDPR), NHS Digital can only collect and use personal data if there is a legal basis under Articles 6 and 9 of the UK GDPR.

Our legal basis for collecting data is GDPR Article 6 (1) (c) legal obligation, Article 9(2)(g) and Article 9 (2) (h) special categories of personal data, Data Protection Act 2018 (DPA) 18 Chapter 2 applicable conditions. 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.

NHS Digital will seek your consent to collect personal data, including your email address, so to send the invite to the PROMs questionnaire. This is specifically to satisfy the Common Law Duty of Confidentiality requirements around using confidential patient information for this trial.

You can read more about the health and care information collected by NHS Digital, and your choices and rights in:

• How we look after your health and care information
• NHS Digital Transparency Notice
• How to make a subject access request
• If you wish to withdraw your consent as part of the PROMs collection, please contact the Data Liaison Team at [email protected].

Our Data Protection Officer is Jon Moore who can be contacted at [email protected].

NHS Digital may make changes to this Transparency Notice. If so, the 'last edited' date on this page will also change. Any changes to this notice will apply immediately from the date of any change.