The Target Therapies -&- SilverCloud Target Trials studies

The University of Sheffield (UoS) and University of London (UCL) require access to NHS England data for the purpose of the following research projects:

Study 1: Target Trials for talking and digital therapies to estimate their real-world effectiveness, cost-effectiveness, and inequalities in outcomes using causal inference techniques applied to NHS Talking Therapies real-world data: The Target Therapies quasi-experimental study

And:

Study 2: Real-world studies of Amwell’s SilverCloud internet-enabled cognitive behavioural therapy (CBT) for adults with depression or generalised/unspecified anxiety disorders compared to individual or group low-intensity CBT to estimate their comparative effectiveness, cost-effectiveness, and inequalities in outcomes: the SilverCloud Target Trials

The following is a summary of the aims of the research projects provided by the UoS and UCL:

This data request is to facilitate the analyses described in two researcher-designed, competitively commissioned, UK NIHR (the independent research commissioning institute of the Department of Health and Social Care [DHSC]) funded research studies. The studies are led by the same principal investigator, are coterminous in time, and have the same data requirements. The respective work packages, encompassing the totality of the processing of the requested data, in both studies are undertaken by the same research teams at UoS and UCL.

Study 1: the Target Therapies study, is a NIHR Research for Patient Benefit (RfPB) funded project. The research question for this study is: among referrals to NHS Talking Therapies for anxiety and depression (TTad) services, how effective and cost-effective are different talking therapies allocated for the same presenting mental disorder for achieving patient- and service-focussed outcomes, and are there outcome inequalities?

Study 2: the SilverCloud Target Trials, is a NIHR Invention for Innovation (i4i) and Office for Life Sciences (OLS) funded project. The research question for this study is: Among NHS TTad-service clients, how effective and cost-effective is SilverCloud internet-enabled CBT compared to low-intensity individual or group CBT for depression or generalised/unspecified anxiety disorders for achieving patient- and service-focussed outcomes, and are there outcome inequalities?

The following NHS England Data will be accessed:

• Improving Access to Psychological Therapies (IAPT) - to identify primary reason for service use, therapies received, adherence to therapies, baseline and outcome measures

• HES APC, HES OP, ECDS and MHSDS - to identify adverse events and also to estimate healthcare utilisation pre- and post- intervention(s).

• Medicines Dispensed in Primary Care - to adjust for use of treatment-relevant medications, proxy outcome measures, healthcare utilisation

• ONS Death registration - to identify adverse events.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

• Limited to individuals who appear in the IAPT dataset between April 2021 until March 2024.

• This cohort will then be linked to the following datasets:

o HES APC & OP: 2021/22 to 2023/24

o ECDS: 2021/22 to 2023/24

o MHSDS: 2021/22 to 2023/24

o IAPT v2: 2021/22 to 2023/24

o Civil Registrations of Death: latest available at point of dissemination

o NHSBSA: latest available at point of dissemination

UCL and UoS are the joint controllers as the organisations responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by DHSC with commissioning and contracting managed by the NIHR under their Research for Patient Benefit (RfPB) and Invention for Innovation (i4i) programmes. The latter programme is additionally supported by the Office for Life Science (part of both DHSC and the Department for Science, Innovation and Technology). The funding is specifically for the studies described.

PhD students involved in processing activities covered by this Data Sharing Agreement (DSA) may be in receipt of funding, to cover their training and their time (a stipend) only, awarded by:

• The Wellcome Trust and University of Sheffield, jointly, under their Wellcome Doctoral Training Centre in Public Health Economics and Decision Science

• University of Sheffield and/or University College London under their studentship programmes.

The funder will have no ability to suppress or otherwise limit the publication of findings.

No other organisation will be acting as a processor.

Other organisations involved in either study are:

• Northumbria University

• The McPin Foundation

• Hardian Health [Hardian Limited]

• Amwell [American Well Corporation]

• Camden and Islington NHS Foundation Trust

• Sheffield Health and Social Care NHS Foundation Trust

The roles of these organisations within the studies are:

• investigating the uptake of internet-enabled talking therapies using interviews, surveys, and workshops

• patient and public engagement;

• investigating commercialisation and adoption of technologies (providing context on how the investigated technologies are commissioned and implemented by services)

• technology partners (providing context around the SilverCloud platform)

• health service representatives.

Data will be accessed by:

• PhD students enrolled with UCL or UoS. Any student working with the Data held under this DSA must have completed relevant data protection and confidentiality training and are subject to UCL (and where applicable, additionally UoS) policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of their host organisation, either UCL or UoS. Their host organisation (UCL or UoS) would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA.;

• Individuals holding an honorary contract under the supervision of a substantive employee of UCL for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

A Public and Patient Involvement and Engagement group helped refine the purpose of the research during the application processes for both of the described studies. The group supported the use of existing (NHS England) data collations for the purposes described under this DSA, including helpful comments around how the study team refer to- and describe- this data. An expanded PPIE group will continue to provide advice to the project team for the duration of the study. The study team call this PPIE group the Lived Experience Advisory Panel (LEAP). The study team will detail the LEAP's input into project planning, development, and dissemination throughout the project on the project website: https://target-trials-mental-health.sites.sheffield.ac.uk

Within the wider NIHR Target Therapies study, the collaborating parties are UoS, UCL, Sheffield Health and Social Care NHS Foundation Trust, and the McPin Foundation (a mental health research charity).

Within the wider NIHR SilverCloud Target Trials study, the collaborating parties are UoS, UCL, University of Northumbria, American Well Corporation UK Ltd, Hardian Ltd, Sheffield Health and Social Care NHS Foundation Trust, Camden and Islington NHS Foundation Trust, and the McPin Foundation.

The wider SilverCloud Target Trials study (beyond work package 4, "the real-word data study" component, which is the focus of this DSA) is a collaboration including the American Well Corporation UK Limited (Amwell) owner of the SilverCloud internet-enabled CBT platform being evaluated in the study; and Hardian Health, a "software as a medical device" consultancy working with Amwell within this project to develop market access strategies. Neither Hardian Health, nor Amwell have any involvement in, nor influence over, the processing of NHSE data in either study. Hardian Health and Amwell are involved (co-lead) two work packages within the NIHR i4i SilverCloud Target Trials study. These work packages involve Intellectual Property, Commercialisation, and Value Proposition focussing on improving internet enabled CBT (iCBT) uptake within- and spreading amongst- Talking Therapies for anxiety and depression services. This will be built upon the outputs of other work packages but will have no input into those other work packages.

Neither Amwell, nor Hardian Health will receive any exclusive reports arising from the NHSE data being processed in the scope of this DSA. The SilverCloud Target Trials study was commissioned under the NIHR invention for innovation (i4i) and Office for Life Sciences (OLS) Real World Evidence (RWE) programme. The study was commissioned primarily to generate high-quality evidence to support the National Institute for Health and Care Excellence’s (NICE’s) early value assessment (EVA) process, which requested RWE based on real-world data (RWD) for its assessment of the use of Amwell's SilverCloud iCBT in the NHS.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the IAPT, HES APC, HES OP, ECDS, MHSDS, Medicines Dispensed in Primary and Death Registration datasets to UCL. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be re-identified through linkage with other data in the possession of the recipient.

The Data will be stored and processed on the UCL Data Safe Haven (DSH), a secure computing environment managed by UCL IT staff. The data will reside on UCL managed servers in England and Wales only and will not be transferred to any other location. The data will remain within the UCL DSH secure computing environment at all times. The data will be securely ingressed into the UCL DSH by the study lead at UCL.

The UCL DSH platform, Virtual Machines, workers and file storage are all held within UCL data centres, which are based in London and Slough, UK. Data (encrypted to AES-256) is also backed up to (stored on) the Cloud provided by Amazon AWS on infrastructure located within England, UK.

Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL’s Data Safe Haven. UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

The Data will be accessed by authorised personnel via remote access.

The Controllers must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave England or Wales at any time.

Access is restricted to employees, persons with honorary contracts and PhD students of UCL and UoS who have authorisation from the study lead at UCL in consultation with the study principal investigator (at UoS).

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data.

All persons accessing the data have been appropriately trained in data protection and confidentiality. All persons accessing the data will be made aware that they must not attempt to re-identify individuals from the (pseudonymised) data.

Researchers from the UCL and UoS will process and analyse the Data for the purposes described above.

Outputs derived from the data will only be removed from the DSH after statistical disclosure controls have been applied, in line with guidance published by NHS England in "Hospital Episode Statistics (HES) Analysis Guide". Specifically, counts of patients at any sub-national level will be rounded to the nearest 5, and censored if the unrounded value is 1-7. Outputs may only be removed from the UCL DSH after approval from the study lead at UCL.

The expected outputs of the processing will be:

• A report of findings for the SilverCloud Target Trials project; for the SilverCloud Target Trials the study team are also producing product-agnostic guidance on how the study team analyse the routine data to answer the study research questions. Such reports are contracted to be produced within one month of the end of the project (i.e., by the end of November 2027).

• Submissions to elite peer-reviewed journals, for example the Lancet Psychiatry, the British Journal of Psychiatry and JAMA Psychiatry. The intention is to write and submit the majority of the relevant manuscripts up to within one month of the project end (i.e., by the end of November 2027).

• Presentations at various national and international conferences, such as the National Institute for Health and Care Excellence (NICE) conference, Health Service Research (HSR) UK, British Association for Behavioural and Cognitive Psychotherapies (BABCP) conference, Society for Psychotherapy Research conference, European Association of Behavioural and Cognitive Therapies (EABCT) conference, World Congress of Congress of Cognitive and Behavioural Therapies (WCCBT) conference, The Professional Society for Health Economics and Outcomes Research (ISPOR), European Health Economics Association (EuHEA), Health Economists' Study Group (HESG).

• Presentations to the clinical networks of NHS TTad services (such as the North and Central East London (NCEL) NHS TTad Service Improvement and Research Network (SIRN)).

• A website will be developed on which the study team will provide working and end-product documents that are not intended for submission to peer-review journals.

• Other outputs will include Patient and Public Involvement (PPI) outputs, with whom the study team will be discussing the role of routine data such as that provided by NHS England for research purposes, with a key focus being to answer questions aligned with the studies’ NIHR funded projects.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

UCL and UoS have planned approaches to dissemination and communication for patients and the public specifically, alongside for academics, TTad-service representatives, commissioners, broader NHS, NICE and HDR-UK.

The McPin Foundation will enhance the study team’s dissemination and impact as a highly recognised and revered PPI group for mental health populations. Adequate time and budget have been allocated to aid dissemination. From project inception, UCL and UoS will develop a ‘Jargon buster’ as a within-study resource and PPI-led output, which includes informing PPI groups about terms used related to routine/real-world data. PPI outputs will be produced alongside team-training and discussions related to real-world studies (e.g., what they are and how they complement RCT evidence) and routine data uses (e.g., who are represented and how this impacts the study’s results). The LEAP will lead PPI focussed outputs, which includes interpretation of thestudy results, how they can be explained in plain English, and ways the results can have meaningful impact for the public and NHS. UCL and UoS have budgeted for two PPI specific dissemination events, to be held around project month-16 and month-34. LEAP representatives will be invited to present, promote, and invite other PPI representatives to dissemination events. UCL and UoS will invite PPI representatives from various backgrounds, including based on ethnicity, deprivation, age, neurodiversity, and LGBTQ+ communities (upper limit: 30 attendees). McPin will ensure they are well-supported before, during, and after the events.

The project has external representatives as part of the study’s Stakeholder Advisory Group (SAG; i.e., mainly TTad-service representatives) and Study Steering Committee (SSC; i.e., academic, clinicians, commissioners, NHS England, NICE, and HDR UK representatives) that will provide early dissemination stimulated through within-meeting discussions and spread by word-of-mouth within their relevant networks. Dissemination and impact will be enhanced by clinical co-applicants and collaborators as highly recognised mental healthcare and guideline experts. Alongside patient and NHS benefits, the study represents methodological advancement for dissemination. Using routine mental health data for causal inference will be of interest to academics, the NIHR, NHS, NICE, and HDR-UK. NICE and HDR-UK representatives will be involved in the SSC and dissemination events, as direct collaborators to aid NHS and wider population dissemination, and direction to how the study’s evidence can inform mental health guidance, NICE Early Value Assessment (EVA) processes, and novel routine data use.

UCL and UoS have budgeted for two generalised dissemination events to which all stakeholders are invited (upper limit: 50 attendees), around project month-17 and month-35, after the PPI specific events so PPI suggestions can be shared more broadly. The study team will present the methods and study results, including broader dissemination plans. LEAP members will be invited to attend and present. Broader collaborators including TTad-service representatives, NICE, and HDR-UK will be invited to present and discuss the broader implications of the results, including potential NHS resource impacts and result implementation considerations (e.g., changing clinical guidance). Attendees will be invited to suggest and participate in broader means of dissemination, and help shape the communicated message to other stakeholders.

Reports are contracted to be produced within one month of the end of the project (i.e., by the end of November 2027).

It is the intention to write and submit the majority of the relevant manuscripts for journals up to within one month of the project end (i.e., by the end of November 2027).

The study’s main impact is expected to be for patient groups, services, and the NHS, due to an improved, NHS-focused, effectiveness and cost-effectiveness evidence-base for different therapy types and modalities. This improved evidence-base should result in better pairing of patients with interventions. This can be actioned through implementing changes to clinical guidance (e.g., NICE guidelines) and increased awareness amongst patients and clinicians. Given that Common Mental Disorders (CMDs) affect ~15% of the population, even small treatment allocation improvements could potentially improve patient benefits and NHS cost-efficiencies/savings.

Alongside the core patient and societal benefit, this study should advance methodological development and adoption. Immediate methodological impact should stem from the study team’s descriptive dissemination about how to utilise existing NHS routine data to conduct causal, real-world evidence studies and how this evidence-base can inform practical decision-making and clinical guidance.

Broader impact would be for those under or not represented within TTad-services and current routine data. The study team will explore and describe what person-level characteristics are captured across the linked datasets (e.g., variables describing neurodiversity and LGBTQ+ communities) to suggest if routine data collection reform is needed to better represent these marginalised populations. Positives and limitations of current data capture is a specific aspect for discussion with NHSE, NICE, and HDR-UK, to explore potential and opportunities for UK healthcare data reform to inform evidence-based practice.

It is hoped the results will inform and strengthen NICE’s real-world evidence framework, as a case-study by which evidence has been produced based on the framework and how it has informed NICE’s processes. NICE’s use of this real-world evidence could have national and international impact on the use of real-world evidence for informing method development and application, clinical guidance, and evidence-based decision-making, including HTA processes going forwards.

The study team would measure impact of the studies through discussions with NICE and regularly reviewing NICE guidelines to assess changes attributed to the study, surveying mental health NHS providers to assess changes to intervention allocation, and citations of statistical and health economic analysis plan and publications informing future analysis plans and outputs.

Dissemination includes via a bespoke project website, social media channels (e.g., X, LinkedIn, YouTube), interactive workshops, web-video, visual, and text-based summaries, and hybrid dissemination events geared towards specific stakeholders such as the public, alongside cross-group dissemination activities and outputs.

Yielded Benefits is not a requirement for new applications.