Good TREs work

Lancaster University projects

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

Mental healthcare use and longer-term outcomes in people with co-occurring mental health conditions and alcohol use disorder. — DARS-NIC-690385-R5D4B

Opt outs honoured: unknown (Excuses: Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(2)(a),

Purposes: No (Academic)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2024-12 – 2025-11 2025.01 — 2025.01.

Access method: System Access, One-Off
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)

Data-controller type: LANCASTER UNIVERSITY

Sublicensing allowed: No

Datasets:

  1. Alcohol Dependency Dataset
  2. Civil Registrations of Death
  3. Hospital Episode Statistics Accident and Emergency (HES A and E)
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Hospital Episode Statistics Outpatients (HES OP)
  6. Mental Health Services Data Set (MHSDS)
  7. Uncurated Low Latency Hospital Data Sets - Emergency Care

Type of data: Anonymised - ICO Code Compliant (note: this information not disclosed for TRE projects )

Objectives:

Lancaster University requires access to NHS England data for the purpose of the following research project:
Mental healthcare use and longer-term outcomes in people with co-occurring mental health conditions and alcohol use disorder.

It is estimated that adults in England with a mental health disorder are more than twice as likely to suffer from an alcohol use disorder (AUD) than the general population, whilst almost two thirds of service users in drug and alcohol treatment report a need for mental health treatment. For individuals with a mental health condition, comorbid AUD is associated with worsened clinical outcomes, increased mortality rate, and reduced treatment adherence. Likewise, comorbid mental health conditions are associated with a reduced likelihood of remission from alcohol dependence and increased relapse risk. Comorbid AUD and other mental health conditions are also associated with high healthcare service utilisation.

Individuals with co-occurring mental health conditions and AUD can respond to treatment and may respond similarly to those without an AUD if they remain in treatment. However, there are inequalities in access to care and treatment for people with co-occurring conditions, with co-occurring conditions more broadly associated with poorer treatment adherence, longer waiting times, and reduced appointment attendance. An understanding of the ways in which treatment pathways differ for individuals with and without an AUD may provide insights into how healthcare and treatment access could be improved for this population. However, these treatment pathways remain largely unexplored.

The above issues are compounded by social inequalities and people of lower socioeconomic status are disproportionately burdened with alcohol-related harms including mortality, and an increased prevalence of mental health disorder. Understanding and addressing health inequalities is a fundamental prerequisite of improving health outcomes. However, social inequalities associated with comorbid AUD remain unestablished for most mental health conditions. Bipolar disorder (BD), for example, is disproportionately prevalent within the North of England, compared to the South of England, and associated with deprivation, reduced life expectancy, and increased suicide risk. However, evidence for BD treatment effectiveness is biased by research centred around the South of England and health inequalities regarding comorbid AUD and BD remain unexplored. Therefore, there is a need to review national records to further understand the inequalities that may be experienced by people with comorbid AUD and BD, as well as other mental health conditions, and to investigate how treatment pathways and outcomes may be impacted.

The following is a summary of the aims of the research project provided by Lancaster University:
• Investigate how the prevalence of co-occurring mental health conditions and AUD (with a focus on co-occurring BD and AUD) across people using secondary mental health services in England differs by geographical region, demographic information (e.g., age, ethnicity), and by level of deprivation.
• Investigate how treatment pathways differ for people with mental health conditions who do or do not have a co-occurring AUD (for example whether patients require inpatient treatment or have a care plan), including whether or not they are seen in acute/hospital trusts.
• Investigate how longer-term outcomes (such as mortality) differ for people with mental health conditions, comparing those who do or do not have a co-occurring AUD, and how longer-term outcomes may associate with different treatment pathways.

Across all research aims, there will be investigation into co-occurring AUD with a range of mental health conditions more broadly. Additionally, there will also be specific focus on co-occurring AUD and BD, as across all mental health conditions, individuals diagnosed with BD report the highest prevalence of alcohol abuse and dependency.

The following NHS England Data will be accessed:
• Mental Health Services Dataset – necessary because the Mental Health Services Data Set (MHSDS) collects robust, comprehensive, national data from people in contact with mental health services across England. This allows investigation into the inequalities that may be experienced by people with comorbid AUD and other mental health conditions, as well as investigation into treatment pathways and outcomes of people with AUD and mental health conditions, on a national level.
• Civil Registrations of Death – necessary because cause of mortality is an important longer-term outcome for the purposes of this research.
• Hospital episode statistics (HES) and Uncurated Low-Latency Emergency Care (ECDS) data – necessary because it details of all annual admissions, A&E attendances, and outpatient appointments at NHS hospitals in England. This allows treatment pathways and outcomes to be investigated across primary (HES) and secondary care (MHSDS).
• Alcohol Dependence – necessary because the dataset uniquely provides information about the activity and impact of Alcohol Care Teams (ACTs) across NHS hospitals, including information about alcohol-related outcomes such as the Alcohol Use Disorders Identification Test (AUDIT). This allows investigation into treatment pathways to include access to and care provided within ACTs, also allows for investigation into alcohol-related outcomes for people with AUD and mental health conditions.

The level of the Data will be pseudonymised.

The Data will be minimised as follows:
• Limited to data from 2016/17 to 2023/24.
• Limited to pseudonymised variables within the HES, Alcohol Dependency, and Civil Registration of Deaths datasets that are relevant to the study objectives.
• Limited to data from individuals within the Mental Health Services Dataset only (ICD-10 codes F01 to F69).

University of Lancaster will be responsible for minimising the HES, uncurated low-latency ECDS, Alcohol Dependency, and Mortality data to only individuals with a recorded mental health diagnosis. Further minimisation will be conducted by the NHS England SDE Data Wranglers who will assist University of Lancaster to conducting data minimisation within the SDE environment.

Lancaster University is the research sponsor and the sole controller who also processes the data, as the organisation 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.

Noting the sensitivity around the Alcohol Dependency and Mental Health datasets, the primary ethical issues considered for the project were around maintaining anonymity.

The funding for the project is twofold. For all activities relating to BD specifically, the funding is provided by the Economic and Social Research Council (ESRC). The funding is specifically for the project described. Funding is in place until 1st October 2026.

For all activities relating to mental health issues other than BD, the funding is provided by the National Institute for Health and Care Research (NIHR), awarded for a wider programme development grant titled “Improving treatment pathways and outcomes for people with co-occurring mental health conditions and alcohol use disorders” (ref: NIHR204587), and also for a future programme grant following this programme development grant. This includes investigation into treatment pathways and longer-term outcomes for individuals with co-occurring mental health conditions and AUD, as outlined in this Data Sharing Agreement.

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

Data will be accessed by a PhD student who is a substantive employee of Lancaster University. The PhD student has completed mandatory data protection and confidentiality training and is subject to Lancaster University’s policies on data protection and confidentiality. The individual accessing the data will do so under the supervision of the Chief Investigator who is a substantive employee of the Lancaster University. Lancaster University would be responsible and liable for any work carried out by the individual. The PhD student would only work on the data for the purposes described in this Data Sharing Agreement (DSA).

The PhD project, which includes all aspects of the project relating to BD, will be informed by a patient and public involvement (PPI) advisory group which is formed of five individuals with lived experience of BD and AUD. To ensure that the project is meaningful for individuals with co-occurring BD and AUD, PPI activities are planned throughout the entire project. Group meetings will be held online every three months, in which individuals will be asked to share their experiences, thoughts, and perspectives on the project. This will allow the group to be involved in all stages of the project, including finalizing the research focus, shaping methodology and analysis plans, interpreting findings, and advising on dissemination materials.

This PhD project will inform a wider NIHR-funded programme which involved PPIE activities. Meetings were held monthly with a PPI advisory group, who were involved in developing and finalising the research questions for the project and discussing uses for routinely collected health data. A representative from the group was also present at all meetings with stakeholders, to ensure that their feedback and perspectives remained central to the project. Across meetings, PPI panel members discussed the importance of investigation into treatment for co-occurring alcohol and mental health, and the use of mental health data to benefit service users.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

Specifically, the findings of this research study could be used:
• By health professionals providing care to individuals with a mental health disorder to understand which of their patients are most at risk of experiencing an AUD, and to therefore provide more targeted alcohol screening and referrals as part of their mental health care.
• To inform broader guidelines and policies regarding alcohol screening and referrals, to further ensure screening and referrals are provided to those most at risk, as earlier screening and referrals are associated with greater clinical outcomes.
• By healthcare professionals when making decisions regarding referrals and treatment decisions for patients with comorbid mental health disorders and AUD, by highlighting which treatments are more suitable for patients with comorbid AUD, and by highlighting how longer-term outcomes associate with different treatment pathways.
• To underpin public health efforts to improve treatment and healthcare access for individuals with comorbid mental health conditions and AUD, by highlighting differences in treatment pathways that this population currently experiences, and therefore highlighting targets for future public health policies or interventions.
• To highlight the potential inequalities experienced by those with a co-occurring AUD, and therefore could be used to inform subsequent public health efforts tackling these inequalities.

The use of the data could:
• Help the system to better understand the health and care needs of populations.
• Lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• Advance understanding of regional and national trends in health and social care needs.
• Inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
• Inform decisions on how to effectively allocate and evaluate funding according to health needs.
• Support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Lancaster University has established relationships with representatives from NHS England, Department of Health and Social Care, Lancashire and South Cumbria NHS Foundation Trust, and mental health and alcohol dependency charities. These organisations will be the most appropriate to act on the research recommendations to implement changes in policy to improve health and social care for individuals with comorbid AUD and mental health conditions.

Outputs:

The expected outputs of the processing will be:
• Annual reports of findings to the relevant funders such as the ESRC and NIHR.
• Submissions to peer reviewed journals (such as the British Journal of Psychiatry and Addiction)
• Presentations at appropriate conferences (such as the British Association for Behaviour and Cognitive Psychotherapies Conference, and the Bipolar UK Annual Conference)
• Outputs will be described and summarised in a PhD thesis.

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

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Conferences
• A booklet outlining lay summary findings and recommendations distributed to relevant stakeholders
• Direct bilateral engagement with relevant organisations such as Bipolar UK, Alcohol Change UK, Health Education England, and Health Data Research UK.
• Blogs such as The Conversation.
• Reports shared with a national stakeholder group which was setup as part of the NIHR research project, including representatives from national public sector organisations (e.g. DHSC, OHID, NHS England), national charities (e.g. Alcohol Change UK, Alcohol Health Alliance, Centre for Mental Health) and they will use the research findings to translate the outcomes into policy recommendations, with the aim to develop updated public health guidance.

Processing:

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

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and analytics tools.

NHS England will provide access to the relevant records from the Mental Health Services, Civil Registrations of Death, Hospital Episode Statistics, Emergency Care, and Alcohol Dependence datasets to Lancaster University. The Data will:
• Contain no direct identifying data items.
• The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Access to the SDE is granted when the SDE user agrees to the terms and conditions of the NHSE SDE User Agreement. SDE user Access to the SDE is controlled via a multi-factor authentication mechanism and access is restricted to the datasets and periods detailed within this agreement. Access and use of the system is fully auditable, and all users must comply with the use of the Data as specified in this DSA and the SDE User Agreement.

Users are only authorised to access the Data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

The Data will be stored on servers at NHS England.

Remote processing will be from secure locations within the UK.

The Data will not leave the UK at any time.

SDE user access is restricted to an individual within Division of Health Research at the Lancaster University. The individual is a PhD student and a substantive employee of the Lancaster University.

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

The Data will be linked by NHS England to the Index of Multiple Deprivation (IMD) which consists of reference tables available in the SDE. IMD is the official measure of relative deprivation in England and allows deprivation to be comprehensively captured given that it comprises 39 individual deprivation indicators across eight domains.

There will be no requirement and no attempt to reidentify individuals when using the Data.

A PhD student Data Analyst from Division of Health Research at the Lancaster University will analyse the Data for the purposes described above.

To produce the expected outputs described in this Data Sharing Agreement, the PhD student is supported by three academic supervisors, including a Senior Lecturer in Mental Health, a Professor of Clinical Psychology, and a Lecturer in Biostatistics (Health Informatics)