NHS Digital Data Release Register - reformatted

Our Future Health projects

1 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


Opt outs honoured: Identifiable (Section 251 NHS Act 2006)

Legal basis: National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: Yes (Charity)

Sensitive: Non-Sensitive

When:DSA runs 2022-06-07 — 2023-06-06

Access method: One-Off

Data-controller type: OUR FUTURE HEALTH

Sublicensing allowed: No

Datasets:

  1. Demographics

Expected Benefits:

Our Future Health aims to give researchers from universities, charities, the NHS and companies involved in health research an opportunity to discover and test more effective ways to predict, detect and treat common diseases such as dementia, cancer, diabetes, heart disease and stroke.

The scale, depth and detail of Our Future Health should make it a world-leading resource for health research. The programme is designed to truly reflect the UK population, including groups of people that have previously been under-represented in health research.

This hopes to be achieved via a cohort selection and invitation process designed to monitor and subsequently over-sample people from under-represented groups, and by targeting areas of the country where people from these groups are resident.
This will occur in addition to a range of other activities planned and/or underway including:
• engagement & awareness activities with national and local community stakeholders and community representatives;
• the establishment of a Diversity & Inclusion Advisory Board who are bringing a wealth of expertise, relevant networks, and experience of engaging under-represented groups in health research and other activities
• over time, developing materials in multiple languages and for different accessibility needs.
In all public consultation, involvement and engagement activities, using qualitative, quantitative and co-design methodological approaches, Our Future Health actively stratify recruitment to oversample individuals from under-represented groups, so that insights they are gaining about attitudes, beliefs and behaviours towards the programme consider these populations.
While consent will be electronic and remote in the first instance, consent rates and acceptability of this approach by underrepresented groups aim to be carefully monitored and explored via conversion rate metrics and analyses, and via public involvement and engagement on this topic; alternative methods hope to be explored over time to reach those who are digitally excluded.

Our Future Health may hold the key to huge numbers of discoveries, such as:
* New signals that could be used to detect diseases much earlier than is currently possible, leading to new or improved screening and prevention programmes and earlier treatment
* New ways to predict with better accuracy who is at higher risk of diseases and would benefit from faster access to screening and prevention interventions
* More targeted or personalised treatments, tools and technologies to delay the onset of disease, or change the course of disease progression; to reduce disease risks; and more targeted ways to investigate diseases for people at higher risk.

The intention is that the Our Future Health programme will provide two key types of resource for health research:
1) A prospective observational dataset for basic science/epidemiological, discovery and aetiological research e.g. on the causes and early signs of disease; and
2) A translational research platform comprising a cohort of people who can be re-contacted for translational/implementation research to develop and test new diagnostic technologies, prevention strategies and treatments.

Outputs:

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2022 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Processing:

As data controller, Our Future Health will provide to NHS Digital the core eligibility criteria for those potential participants who will receive invitations. Our Future Health refine the population that receive these invitations based on first half of a postcode, making adjustments as required to ensure adequate representation of target populations.

NHS Digital would be using an established contract with a mailing provider (APS Group) to fulfil the communications. The APS Group are also used by NHS England and NHS Improvement as a marketing service group that is a recognised and trusted provider of NHS Services. They are used frequently to co-ordinate mail outs for NHS Bodies. APS Group will use Research Ethics Committee (REC)-approved template invitation letters and would add address details onto the letters prior to mailing it out. All identifiable data provided to APS Group by NHS Digital will be done so under the legal basis of Section 251 support as provided by the Confidentiality Advisory Group (CAG) for this particular programme.

Data processing is carried out by substantive employees of NHS Digital who have been appropriately trained in data protection and confidentiality. NHS Digital will access records allowing them to gather the following information needed to determine suitability for invitation to the Our Future Health programme.

COHORT SPECIFICATION:
• Our Future Health are accountable for providing the specification to NHS Digital for each mail out. These specifications will be based on a combination of multiple postcodes, age limits, gender balances and ethnicities for potential participants. The information they will provide to NHS Digital on each occasion is:
• An Invitation code for each request (this will be generic for each mailing, not participant specific)
• Lower and upper age limits (18 and over as per the inclusion criteria).
• Male / female percentage split, if required.
• A selection of postcodes (first half of postcode only), if required.
• The number of invitations required for each request.
• The geographical specifications are based on the locations of the mobile clinics where potential participants will be invited to take part in the programme.
• At a pre-determined point, Our Future Health will transfer details of the specification to NHS Digital via SEFT. This will be on a flexible adhoc basis, determined by the number of responses received for each request.

COHORT IDENTIFICATION:
• Using the inclusion and exclusion criteria as specified by Our Future Health, NHS Digital will interrogate the Patient Demographics Service (PDS) dataset and extract all those potential participants who meet the criteria within the latest specification as provided by Our Future Health.
• NHS Digital will then remove any records where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.
• The remaining records will have their relevant contact details (Forename, Surname, Address, Postcode) extracted ready for despatch to APS Group, as well as a mailing-specific invitation code.

COHORT DISSEMINATION AND MAILOUT:
• Each time NHS Digital create and disseminate an extract, the records will be added to a mailing list cohort dataset. Every time a fresh extract is produced, it will be checked to ensure that any records appearing in this mailing list dataset are removed in order to prevent potential participants receiving multiple invitations. This mailing list dataset will be maintained for six months after the invitation process is complete in case this is required for analysis purposes by Our Future Health. Only aggregated data would be used for such analysis.
• NHS Digital will provide APS Group with Forename, Surname, Address, Postcode and Invitation code via Secure Electronic File Transfer (SEFT.)
• APS will then mail out to individuals as required.
• All potential participants will receive an invitation letter containing their Name, Address and Postcode and Invitation code. When the recipient goes to register into the programme they will be asked to provide an Invitation code. Our Future Health will use this code only to identify which mail-out / recruitment method the recipient received.
• APS will destroy all data received from NHS Digital two weeks after mailing as instructed by NHS Digital.

COHORT ANALYSIS:
• After each request for invitation, NHS Digital will provide Our Future Health with a summary report containing non-identifiable information in an aggregate formation with small numbers suppressed, relating to how that request was met, for example, number of invitations requested versus number of invitations actually sent. This will aid planning for subsequent invitation requests.

PILOT MAIL OUT
NHS Digital and Our Future Health are analysing different variants of invite letters and inserts to determine the best way to reassure recipients as to trustworthiness (both in terms of the letter not being a scam and in terms of the intentions of the letter being as stated). Differences in the response rates from these methods will be evaluated to inform which will be used in the long term. The analysis will also help determine the wording which appeals most to people to then visit the Our Future Health website for more information and/or actively sign up to the programme. Interested patients will be directed to the Our Future Health web-based system, where they can electronically consent to participate. Only at this point will Our Future Health receive patient information.

As part of pre-testing, NHS Digital circulated different variants of Our Future Health invite letters to participants of a market research panel. Each participant received a randomly selected letter variant (seven variants in total made up of one control and six experimental), and were asked questions about their perceptions of it. NHS Digital analysed the results which showed that two of the variants outperformed the control and both reported likelihood to visit the website and likelihood to take part in research. These two letter variants, a further variant which will undergo more pre-testing, and the control letter (the original recruitment letter used by Our Future Health) will be sent to the public as part of Our Future Health's invitation to health research, commencing in summer 2022 after an initial testing period. Each invitee will receive one of the four letter variations either as an invitation letter without insert, an invitation letter plus a short leaflet, or an invitation letter plus the full participant information sheet.

No patient data will flow from Our Future Health to NHS Digital and vice versa.

The permitted territory of use for data provided by NHS Digital for this agreement is England and Wales.

Potential participants will receive one postal invitation from NHS Digitrials; there will be no attempts to remind or re-approach patients who do not respond to the postal invitation. Over time, and in parallel to each other, Our Future Health will invite potential participants via multiple invitation partners, of which NHS Digitrials will be one. In order to mitigate the risk of individuals signing up to the programme via more than one invitation route, the invitation letter from Our Future Health will include a paragraph identifying that the invitation letter has been issued randomly, and if the recipient has already joined the programme, or if the recipient has joined and then withdrawn, they should ignore the letter.

An aggregate report with small numbers supressed (as per the HES Analysis Guide) containing information about gender, ethnicity, age and geographic demographics of the mailing cohort will be provided to Our Future Health from NHS Digital for the purposes of confirming that inclusion and exclusion criteria have been met for each mailing. This report will also contain the total number of people who received the mail out and the number of people removed from the cohort prior to mailing based on trial-specific opt out, national data opt out and special categories of people for whom the data should not be disseminated, such as those on a witness protection programme.

In order to create the cohort, the Hospital Episode Statistics (HES) Admitted Patient Care (APC) dataset will be cross referenced with the Demographics dataset (meeting the inclusion and exclusion criteria as determined by Our Future Health). This is being done in order to extract ethnicity data, which cannot be obtained from the Demographics dataset alone. Please note, however, that HES APC is not considered a data product on this Data Sharing Agreement as no record level HES APC data will be shared with either Our Future Health or APS Group. The processing of HES APC data is covered under a separate Data Processing Agreement between NHS Digital and Our Future Health.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. The data from NHS Digital will not be linked to any other data other than those outlined in this Agreement.