NHS Digital Data Release Register - reformatted

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED projects

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


Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: (Supplier, Commercial)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:2021.01 — 2021.02. DSA runs 2020-10-20 — 2021-10-19

Access method: One-Off

Data-controller type: GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Outpatients
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Critical Care

Objectives:

Healthcare resource utilisations (HCRU) is the quantifiable measure of a person’s use of services for the purpose of both preventing and curing health problems, the promotion of maintenance of health and wellbeing. Through systematic review the disease burden experienced by both the patient and their healthcare providers can be assessed.

There are two objectives for the processing:

First objective: to assess the feasibility of using routine healthcare data to collect secondary care healthcare resource utilisation data (all cause and COPD related) in clinical trials using HES data for patients consented into the INTREPID study. The study will describe the recording (available in HES, yes/no) and completeness (% non-missing values) of different components of secondary care HCRU and the ability to apply Healthcare Resource Group (HRG) tariffs to these where possible.

Second Objective: to use the HES data to summarise HCRU and costs using HRG tariffs for COPD patients (all cause and COPD related) on inhaled triple therapy for patients consented into the INTREPID study.

(HRG is analysed using the latest publicly available National Cost Collection: https://improvement.nhs.uk/resources/national-cost-collection/)

This study will consider the following HCRU and cost outcomes (all cause and COPD related):

• Secondary care outpatient attendance
• Hospital admission
• ICU admission during hospital admission
• A&E attendance
• Secondary care costs

Background to the request

The highly controlled conditions of a randomised clinical trial (RCT) remove factors that influence and differentiate the use of medicines in everyday clinical practice. Effectiveness data generated in the broader population observed in an everyday clinical setting is increasingly being recognised as important in complementing data derived from the pivotal Phase III safety and efficacy studies.

The primary purpose of the wider study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. This study was conducted once TRELEGY ELLIPTA had been approved and is available commercially.

Primary care Electronic Medical Records (EMR) do not accurately and reliably capture complete information about hospital attendances and admissions. Therefore, to assess the full spectrum of healthcare resource utilisation by individual patients consented into the INTREPID study, additional information is required. The data requested will enable research to be carried out to better understand the service impact on the National Health Service (NHS) for patients; some examples have been provided below:

• A better understanding of A&E attendances relating to acute exacerbations of COPD.
• Understanding which admissions represent serious events.

By understanding the above the data will enhance the understanding of a patient’s experience of the study drug by providing additional information, not readily available elsewhere, on their health during the trial period.
In addition, primary and available secondary healthcare resource utilisation data including prescriptions associated with COPD and related medical conditions will be collected in the electronic Case Report Form (eCRF) by the investigator and study-site personnel for all participants and combined with the Hospital Episode Statistics (HES) datasets being applied for in this agreement. Visits and contacts that are due to a moderate or severe COPD exacerbation will be assessed and recorded.

The data collected within the eCRF for the wider study will include:

• Primary healthcare contacts
• Medications
• Hospital admissions, outpatient appointments and A&E attendances

Organisations involved

• GlaxoSmithKline (GSK): The sponsor for the INTREPID study. GSK wish to receive the final pseudonymised cut of study data, including HES data provided by NHS Digital. GSK are both a data controller and processor for this study.

• Ignite Data (IGNITE): IGNITE will have the explicit consent of participants for receiving their HES data linked to their unique study ID for processing the data on GSK’s behalf and pseudonymisation prior to delivery for research. IGNITE will have access to the record level data to complete this work and this has been made clear to the Participants in the study information sheet and Informed Consent Form (ICF) the Participants complete. IGNITE will destroy the data once data processing has been completed.

Cohort

Number of participants in England = 835 (this will be the maximum cohort size).
The cohort was recruited to the main randomised controlled trial (RCT) element of the study. Each patient has a current diagnosis of Chronic obstructive pulmonary disease (COPD) and was eligible for a triple therapy treatment. Each individual patient was recruited via the study site, which for the most part was their local GP. The GP Practices were selected from across the country. In a small number of cases the patient may have been referred from another local GP Practice or referred to an alternative local site (e.g. a hospital). Each patient in the cohort was then consented and managed by this local study site. The RCT data was then collected at a serious of standard study visits at the patient’s specific study site.

Data Summary

GSK are requesting IGNITE receive access to record-level identifiable data from the following Hospital Episode Statistics (HES) datasets:

• HES Admitted Patient Care
• HES Accident and Emergency
• HES Critical Care
• HES Outpatients

The data requested will enhance the analysis of Healthcare Resource Utilisation by supplementing what has been located in the patient’s primary care records and what can be feasibly collected via eCRFs. As detailed above, this will enable research into the primary and secondary objectives.

The application is commercially funded by GSK. The data is only being used for the purposes stated above. GSK has a corporate policy to publish results of all research, regardless of whether they reflect positively or negatively on their medicines. https://www.gsk.com/en-gb/research-and-development/trials-in-people/data-transparency/

General Data Protection Regulation Article 6 (1) (f) Legitimate interests as this is for the benefit of science and public health.
All patients have been fully informed of the data processing and the organisations carrying out the data processing. Each individual has provided explicit informed consent. The research provides wider public benefit and the risks to the individuals are low.

As special category data, the data is further being processed under article 9(2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes). This is because the consented data will be used to enhance the potential outcomes and improve care, which is in the public interest.

The patient ICF makes reference to this specific healthcare resource utilisation work in the ‘Use of National Healthcare Data’ section.

Expected Benefits:

A full picture of the real-world implications of COPD and its treatment can only be formed when all interactions with the healthcare services can be appraised. The results from this study will provide insight into how real-world patients interacted with the UK healthcare system whilst they participated in this study. The dissemination of this information will be included into the wider outputs of the INTREPID study, where the objectives are to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. Improved understanding of COPD and its treatment will improve patient outcomes and reduce the burden on the UK healthcare service by:

• Improving understanding of the workload of healthcare placed on the patient in this population, for example, the frequency of COPD related outpatient visits and how this relates to total frequency of all-cause outpatient visits in patients taking triple inhaled therapy
• Improving understanding of serious events in this population, such as hospitalisation for acute exacerbation of COPD in patients taking triple inhaled therapy
• Improving ability to understand if the clinical research community can conduct medical research and answer these types of question more effectively and efficiently in the UK using these types of data.

As the second most common reason for emergency medical admission in the UK, COPD represents a substantial cost to the NHS. The datasets provided will be analysed to better understand the healthcare resource utilisation of patients included in this study. The dissemination of this information will expand the understanding of disease burden for patients initiating triple inhaled therapy in the UK. Information on cost and healthcare resource utilisation are used by organisations such as the NHS when making decisions on the organisation and delivery of care. The information generated from this analysis will, for example, provide valuable information on which aspects of secondary care represent the highest use of healthcare resource in this population. This information is valuable to the NHS as it can be used to determine which aspects of secondary care, if targeted could yield the greatest reduction in overall healthcare resource utilisation and costs. Reduction of overall healthcare resource utilisation and costs in one area, for example, reduction in unplanned COPD admissions means that more resources could be spent on another area, for example on preventative healthcare services.

The outputs are integral to the analysis of the Healthcare Resource Utilisation of patients in the study, as they are the most accurate representation of the patient’s interactions with the UK healthcare service. They are also required so that an assessment of data available within pre-existing datasets can be made against that captured within the eCRF.

Outputs:

The wider INTREPID study will produce a study report, which will be published in the public domain.

As part of the wider INTREPID study, further submissions to peer reviewed journals, presentations and conferences may be made. At this stage, it is hard to determine the impact of the data processed as part of this application. If anything of significance identified as part of the objectives, these would form part of the wider INTREPID study publications.

Any published results would contain data which has been minimised and aggregated to ensure privacy is maintained. All data in outputs will be published in-line with GSK policies.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.

In accordance with GSK’s internal policy, all trial results will be shared, regardless of whether they reflect positively or negatively on GSKs medicines. GSK posted information about the INTREPID study on a publicly accessible register (ClinicalTrials.Gov - https://clinicaltrials.gov/ct2/show/NCT03467425) before it started and will update it with a result summary after the study is finished. GSK seek the publication of all results of all clinical trials in peer-reviewed scientific journals and the INTREPID study and any relevant result found as part of the data processing activities in this application will be no different.

The last patient last visit for the INTREPID study was October 2019. The date analysis of the real-world data captured during the study has begun. At present, it is estimated that initial results may be published in mid to late 2021.

GSK has published policies for sharing outputs on its website, found at : https://www.gsk.com/media/2946/disclosure-of-clinical-trial-information-policy.pdf.

Processing:

GSK request access to the data under the data flows described below:

1. Participating practises collect consent from patients using ICF and collect patient identifiers including NHS Number, First Name, Surname, Date of Birth and Postcode.

2. Practises transfer copies of completed ICFs and file containing patient identifiers to IGNITE via password protected email. IGNITE store ICFs and patient data using Cloud Storage provided by Microsoft Azure. For this reason Microsoft Azure are included as a Data Processor and the appropriate data centre locations have been included in this request.

3. IGNITE then apply a unique Study ID to each participant to form a Subject Log of all participants and associated identifiers.

4. IGNITE submit Subject Log containing all cohort data including identifiers to NHS Digital for linkage to HES datasets.

5. NHS Digital provide HES data for all 835 cohort members to IGNITE via Secure Electronic File Transfer (SEFT). This data will be received by IGNITE and stored on Cloud Storage provided by Microsoft Azure.

6. IGNITE will link NHS Digital data to pseudonymised clinical trial data using Study ID. IGNITE will remove all patients’ identifiers except for Study ID.

7. IGNITE will transfer the linked, pseudonymised dataset to GSK for analysis where:
a. The data will be processed to produce descriptive statistics on the patient cohort. Initially, the feasibility of assessing each component of healthcare resource utilisation HCRU will be assessed by tabulating missingness of key variables. Where variables have a low degree of missingness the team will summarise HCRU using means, medians and proportions as appropriate both for COPD related and all cause HCRU. For example, frequency and mean length of stay in hospital for COPD related and all-cause in-patient hospitalisations to understand admitted patient care; average frequency of respiratory related emergency department attendance to better understand COPD exacerbations resulting in A&E attendance; and average frequency of attendance at outpatient clinics to better understand the use of secondary care services in this patient group. The team will summarise HCRU overall and by important subgroups where there are sufficient numbers.

In this study, directly identifiable personal and sensitive personal information is determined to be the Participant Surname, Forename, Date of Birth, NHS Number, Address and Post Code. This data is legitimately required by Ignite to hold for administrative purposes and to pass to NHS digital for Participant record identification purposes. IGNITE have the explicit consent of participants for receiving their HES data linked to their unique study ID for processing the data on GSK’s behalf and pseudonymisation prior to delivery for research.

The data will be linked to pseudonymised clinical trial data obtained during a patients’ participation using a code (GSK Study ID). This will enhance the understanding of their Healthcare Resource Utilisation during their study participation. The dataset provided by NHS Digital will be pseudonymised using a study specific identifier by IGNITE prior to sending to GSK for analysis.

IGNITE will have access to the record level data to complete this work and this has been made clear to the participant in the Patient Information Sheet (PIS) and Informed Consent Form (ICF) the participants have completed. IGNITE will destroy the data once data processing has been complete in-line with GDPR and Good Clinical Practise (GCP) law.

IGNITE and GSK the only organisations involved in this agreement. At both GSK and IGNITE data access is restricted to specific research teams and is only accessible to members of these teams via role-based access controls to file shares and servers. All members of these teams are substantively employed by IGNITE or GSK.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.

Microsoft Ltd provide Azure Backup Storage Services for IGNITE Data Limited and are therefore listed as a data processor. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. No record level data disseminated by NHS Digital will leave England and Wales.


NHS Digital reminds all organisations party to this agreement of the need to comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).