Mental Disorder and Cancer Care: a Data Linkage Study in South London II (ODR1516_358)

South London and Maudsley NHS Foundation Trust (SLaM) requires access to NHS England data for the purpose of the following research project: “Mental Disorder and Cancer Care: A Data Linkage Study in South London II”.

The following is a summary of the aims of the research project provided by South London and Maudsley NHS Foundation Trust:

The original purpose of this project was to update the previous data linkage between mental healthcare data from SLaM and cancer registry data from the Thames Cancer Registry, thereby adding cases and increasing sample sizes for analysis. The updated linkage also incorporated additional linkage with hospital episode statistics for secondary physical healthcare and mortality data by Public Health England under reference number ODR1516_358. The linkage was completed in 2019 and the methodology and governance for the data linkage is described in detail in the accompanying agreement. This agreement is seeking to retain the data and no new data linkage is proposed.

The aims and objectives of the project are:

1. To compare receipt of screening uptake, referral to secondary healthcare, and timing of cancer treatments following cancer diagnosis between groups with and without mental disorder, taking into account type of cancer and spread at diagnosis.

2. To assemble cohorts of residents in South London (Lambeth, Southwark, Lewisham, and Croydon) receiving cancer diagnoses (i,e. ascertained from NCRS) with and without prior mental disorder diagnoses, supplemented by the linkages to HES, for the analyses described below:

a. To compare cancer incidence between groups.

b. To confirm previous findings from the initial linkage that people with mental disorders are not more likely to have cancer spread (beyond local) at diagnosis but do still have higher post-diagnosis mortality. These analyses will be extended to investigate whether the raised mortality is specific to particular causes of death.

3. To investigate the extent to which differences in intervention receipt for cancer account for differences between cohorts in post-diagnosis survival.

4. To assess the impact of cancer diagnosis/ treatment on mental health outcomes (i.e., hospitalisation duration and readmission, mental health service contact and adherence to mental health treatment) in people with pre-existing mental disorders. For people who have subsequently died after a cancer diagnosis: to compare place of death (home vs. hospital) in people with/without prior mental disorders, and to compare the amount of hospitalisation in the final 3-6 months of life.

The following NHS England data will be accessed:

• Cancer Registration – necessary to identify incidence of cancer diagnosis

• Hospital Episode Statistics Admitted Patient Care (HESAPC), Hospital Episode Statistics Accident & Emergency (HESAE), Hospital Episode Statistics Outpatients (HESOP) – necessary to compare treatment of cancer and or other morbidities between cases and controls

• Diagnostic Imaging Dataset (DID) – necessary to compare treatment of cancer, clinical features and other co-founding variables, e.g. spread of cancer, between cases and controls

• Systemic Anti-Cancer Therapy (SACT) - necessary to compare treatment of cancer between cases and controls

The level of the data will be pseudonymised.

The data will be minimised as follows:

• Limited to data from 01/01/2007;

• Limited to conditions relevant to the study identified by specific ICD or OPCS codes;

- ICD-10 codes: C00-D48

• Limited to the following geographic areas: Lambeth, Southwark, Croydon, and Lewisham, which are the boroughs served by the South London and Maudsley NHS Foundation Trust

• Controls will be limited to 5 patients for each linked case subject, control patients will be conterminous and resident in the areas covered by the SLAM population and same temporality and tumour site coding

The minimisation per use will be reviewed and approved by the CRIS Oversight Committee. The CRIS Oversight Committee carries representation from the SLaM Caldicott Guardian and is chaired by a service user. The CRIS Oversight Committee is responsible for ensuring all research agreements comply with ethical and legal guidelines. It closely reviews, monitors and audits agreements to access CRIS and the analyses subsequently carried out

South London and Maudsley NHS Foundation Trust is the controller 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

The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for scientific research purposes

This processing is in the public interest because this study will enhance mental healthcare among cancer patients, whether or not they have existing mental disorder prior to cancer being diagnosed, and benefit the quality of end-life care for people with comorbid cancer and mental disorders.

The funding is provided by the NIHR Maudsley Biomedical Research Centre. Funding is in place until November 2027.

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

Microsoft Limited provides IT hosting services to South London and Maudsley NHS Foundation Trust and will store the data as contracted by South London and Maudsley NHS Foundation Trust.

No other organisation will access data.

Data will be accessed by researchers affiliated with South London and Maudsley NHS Foundation Trust and Masters students. Any student working with the data held under this Agreement must have completed relevant data protection and confidentiality training and are subject to South London and Maudsley NHS Foundation Trust‘s policies on data protection and confidentiality. Any students accessing the data will do so under the supervision of a substantive employee of South London and Maudsley NHS Foundation Trust. South London and Maudsley NHS Foundation Trust 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 Agreement.

The project has three individuals with honorary contracts, two are from Kings College London and one is from University College London. As the objectives are very broad, these are split into sub-objectives and all three honorary contract holders will be working on the data analysis of a sub-project which sits under the wider objectives of the study. The researchers accessing the data are subject matter experts and additionally there are no resources in SLaM to analyse the data so honorary contracts have been issued. The applicant confirms that they hold signed copies of all of their honorary contracts.

The data linkage was set up and has been developed in response to concerns raised by mental health service users locally and nationally over many years around the well-recognised but persisting physical health inequalities faced by people with mental health disorders. In a strategy prepared for the Maudsley Biomedical Research Centre by service users, physical health outcomes were highlighted as a high priority for research. This has resulted in a broader programme of development, of which the data linkage here is just one component, to assemble data resources in which inequalities in care and outcome might be more systematically investigated.

In line with the National data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and (11) of the National Health Service Act 2006.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA).

South London and Maudsley NHS Foundation Trust provided a pseudonymisation key to Public Health England 2019. The key was used by the analysts to pseudonymise the data at source. No personal identifiable data was ever supplied to Public Health England.

Public Health England provided the relevant records from the Cancer Registration, all HES datasets, Diagnostic Imaging Dataset and the Systemic Anti-Cancer Therapy datasets to South London and Maudsley NHS Foundation Trust. The data contained no direct identifying data items contained a pseudonymised NHS Number which was used to link the data with other record level data (Clinical Record Interactive Search [CRIS] ) already held by the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at Microsoft Limited.

South London and Maudsley NHS Foundation Trust stores data on the Azure Cloud provided by Microsoft Limited.

The data will be accessed by authorised personnel both remotely and on site at the South London and Maudsley NHS Foundation Trust . The data will remain on the servers at Microsoft Limited at all times.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to individuals with a substantive or honorary contract with the South London and Maudsley NHS Foundation Trust who have authorisation from the CRIS Oversight Committee.

Microsoft Limited is not permitted to access the data.

All personnel accessing the data have been appropriately trained in data protection and confidentiality and are required to provide evidence of Information Governance training on an annual basis.

The data will be linked at person record level with the (deidentified) Clinical Record Interactive Search (CRIS) and Thames Cancer Registry (TCR) datasets. CRIS is SLaMs mental health database. A data linkage was set up in 2011 between CRIS and Thames Cancer Registry (TCR) as a pilot attempt for feasibility. This contained TCR data on all cancer cases diagnosed in 1999-2008 from four boroughs of south London (with follow-up till June 2010), linked to CRIS data on those who had received mental healthcare from SLAM starting in 2007.

The pseudonymisation key will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the South London and Maudsley NHS Foundation Trust will analyse the data for the purposes described above.

The expected outputs of the processing will be submissions to peer reviewed journals throughout the lifetime of the project and through presentations.

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.

Key findings from this research will be disseminated through peer reviewed journals (published in open-source format) and via presentations. SLaM will work with their Biomedial Research Centre (BRC) who already have extensive and longstanding links to policy makers. Working with BRC communications colleagues will help to maximise these outputs to policy and public dissemination, including publishing CRIS blogs which are short lay overviews of important projects that are taking place using CRIS and highlight specific work taking place available to view on the website. CRIS is a computer system that allows researchers at the BRC to carry out research using information from SLaM which feature on the Maudsley BRC website (https://www.maudsleybrc.nihr.ac.uk/blog/?category=CRIS%20blog).

Initial manuscripts for peer reviewed journals will be prepared and submitted from June 2023. The planned target for initial outputs run into 2024 however outputs (i.e. publications in journals, presentations at academic conferences, etc.) will be ongoing throughout the life-span of the project until 2026.

The hope is to put together a clearer picture of how mental health may impact on quality of care which the research team will endeavour to flag the journal papers to policy makers by working with SLaMs BRC communication colleagues who have strong established link to policy makers.

Benefits will be achieved through replicable points of inequality identified and effectively disseminated which in turn will feed into the design and implementation of improved healthcare pathways, likely to involve both cancer care and mental healthcare specialties.

The proposed outputs are relatively simple and easily communicated, namely whether people with mental health disorders have a higher-than-expected cancer incidence, whether they are more likely to present with cancer at a late stage, whether they receive equitable investigation and treatment following a cancer diagnosis, and the extent to which any of these inequalities account for worse outcomes. Some of these have more of a public health relevance (e.g., cancer incidence) and others are more relevant to primary or secondary care (e.g., inequalities in treatment/investigations), therefore communications will need to be appropriately targeted. As mentioned earlier, it is important to bear in mind that some of these questions are broader than just the cancer example – i.e., inequalities in investigation and treatment may well have commonalities across many physical health conditions (e.g., investigations underway into quality of diabetes care). In addition, there is over-arching clarification needed on the sub-populations of mental health service users who are most vulnerable to health inequalities (e.g., by diagnostic group, by level/nature of service contact, by cross-diagnostic symptom profiles).

These proposed outputs represent a step towards realising public benefits – i.e., by identifying and defining points of inequality so that these can be acted on. The strategies required to address inequalities clearly require further research and evaluation. However, at the moment, the paradigm focuses strongly on cardiovascular risk and prevention, whereas there may well need to be wider attention paid to receipt of equitable healthcare following a diagnosis. Preliminary research using an earlier cancer registry linkage, for example, showed that people with severe mental disorders did not have higher cancer incidence or later stage of cancer at presentation; however, their mortality after cancer diagnosis remained significantly higher, suggesting inequitable treatment as an important concern (and hence the continued proposed use of this valuable linked data resource).

The collaboration between NHS (South London and Maudsley) and university (King’s College London) sectors in the NIHR Maudsley Biomedical Research Centre will help with effective dissemination, as there are already extensive and longstanding links to policy makers. Examples include the influence of our early findings of reduced life expectancy in severe mental illness (still the only/primary UK findings for this outcome) on government policy around improving physical health in mental healthcare, as well as the influence of our work on early COVID-19 era mortality in achieving vaccine prioritisation for people with severe mental illness. SLaM also benefit from strong links with cancer specialists and primary care through King’s Health Partners, which have helped with previous dissemination. As well as policy links, personal connections maintained by SLaM/KCL colleagues with major charities and mental health service user groups can also be drawn on as findings emerge. This of course goes above and beyond standard academic routes of dissemination via publication and conference presentation.

This valuable and unique linkage between mental healthcare and cancer care data has allowed several studies to be carried out on cancer as experienced by people with mental disorders. One set of findings compares cancer incidence rates with those expected in the source population, following previous reports from other cohorts of lower-than-expected risk; it confirms these findings and adds new information on variation between mental disorders. Another study is investigating differences in stage of cancer at presentation and a third is investigating associations with different pathways to diagnosis. In addition, several studies underway are comparing cancer care outcomes following the initial diagnosis in people with/without a diagnosed mental disorder. We therefore hope to put together a clearer picture of how mental health may impact on quality of cancer care which we will endeavour to flag to policy makers.