NHS Digital Data Release Register - reformatted
University of Liverpool
Opt outs honoured: N
Basis: Health and Social Care Act 2012
Format: Anonymised - ICO code compliant Non Sensitive
How often: Ongoing
When: unknown — 11/2016
HSCIC Id: DARS-NIC-14337-J4N1T-v0.6
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Accident and Emergency
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Critical Care
Data: Hospital Episode Statistics Outpatients
Data: MRIS - Flagging Current Status Report
Data: MRIS - Cause of Death Report
Data: Hospital Episode Statistics Accident and Emergency
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Outpatients
Data: Hospital Episode Statistics Outpatients
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Accident and Emergency
Data: MRIS - Flagging Current Status Report
Data: MRIS - Cause of Death Report
Output: Data already received from NHS digital has not had any analysis undertaken, nor any data published/released or reported upon. Data received to date has been utilised to update the UKLS database to ensure University of Liverpool did not contact deceased individuals.
The initial findings/conclusions of the trial data were published in the BMJ-Thorax Online First. This included methods, trial design, recruitment, randomisation, nodule management, number of cancers, treatment, cost effectiveness modelling. The full report of these aspects of the UKLS trial has also been published by the funder, National Institute for Health Research, Health Technology Assessment Programme (NIHR HTA). Both of these are available as open publications.
Future specific outputs anticipated June to December 2017 in the form of presentations/publications and peer review journals will be added to the UKLS website.
One specific output will be a report to the UK National Screening Committee on the cost effectiveness and mortality benefit of introducing a lung cancer screening programme into the UK. Prior to this report it will be necessary for the statistician to analyse the data on causes of death and lung cancer diagnoses.
The UKLS statistician is also designing a risk model to predict lung cancer utilising nodule data from the UKLS study and, if successful, will be submitted for publication. The most appropriate publication will be identified when the analysis is complete. This may include Epidemiological or Radiological publications, such as BMJ-Thorax. Submission to a publication does not guarantee acceptance so it may be submitted to more than one publication before being accepted.
Outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
Activities: An updated cohort Excel file (containing details of participants who have given informed consent) will be sent to NHS Digital by UKLS Project Manager. The updated cohort file is as a result of removal of those participants who have died (as informed by previous data received from NHS Digital).
NHS Digital will upload linked dataset file onto their secure portal and notify UKLS Lung Cancer IT technician. The file will be downloaded and saved as a password protected document into a folder.
The UKLS Project Manager will update the UKLS database with deaths and cancers notified to ensure no further contact with those individuals is attempted.
The Lung Cancer IT Technician will write/run queries to extract selected data from the UKLS ONS/Cancer Registry database. The output will include the pseudonymised unique patient identifier (MPI) in order that it can be linked to subject data held by UKLS. Subject data is data that has been provided by the participants as part of the trail. For those randomised to the CT screening arm, details of CT scan results are held and any treatment received as part of the trial. This data will not be linked with any other patient-level data.
Researchers have access to the pseudonymised data for analysis only, which is imported into statistical software, usually SAS, STATA, or Excel.
Only substantive employees of the University of Liverpool will process the data and only for the purpose as defined in this agreement.
The analysis (as anonymised, aggregate data) will be the subject of publication (see specific outputs), however record level data will be viewed by the named users in this agreement only.
The clinical database used within the UKLS has data for 4,061 subjects; all data is held securely (with additional password protection) and accessed only by the named users, in compliance with The University of Liverpool Data Policies. Although the database includes NHS numbers, only pseudonymised data will be made available to researchers, subjects will be identified using a pseudonymised unique identifier in any extracted data.
Any analysis will be viewed by the named users in this agreement only, further data sharing beyond the named users may be required in the future however this will be requested by means of a further application to NHS Digital.
Objective: The overall aim of the trial was to provide data required for an informed decision about the introduction of population screening for lung cancer. This involved establishing the impact of screening on lung cancer mortality, determining the best screening strategy and assessing the physical and psychological consequences and the health implications of screening. An additional objective was to create a resource for future improvements to screening strategies.
It was initially anticipated that the pilot study would be followed by a more in-depth extended trial with a larger cohort of people. This did not receive further funding however and data will be limited to the pilot study with a cohort of 4,061 participants, of which recruitment has now ended. Although further data is being requested under this agreement, it will be 'follow up' data for the original cohort only e.g. Cause of Death, Date of Death and Cancer Registry data.
The data will be recorded on the United Kingdom Lung Cancer Screening Trial (UKLS) database and pseudonymised data given to the named researchers in order to ascertain any mortality advantage to screening and inform the UK National Screening committee.
Any future sharing of record-level data would be subject to an amendment application requiring NHS Digital approval.
Benefits: ONS Mortality and Cancer Registry Data have been received on a quarterly basis since 2012. This was vital information during the conduct of the trial as any deceased participants, or those diagnosed with lung cancer, were annotated on the database and marked as "Off Study" so that the UKLS project team would not contact them again to arrange repeat scans or complete follow up questionnaires.
The trial has now finished but the follow up data on deaths and lung cancer diagnosis is still required. Once the outcome data is available, the success of the screening can be evaluated. This analysis will be provided to the UK National Screening Committee (UKNSC) to help inform decision-making as to whether a lung cancer screening programme should be implemented in the UK. The UKNSC will not be using only the UKLS analysis, but will also receive analysis from a larger lung cancer screening trial run in the Netherlands (NELSON - European Nederlands-Leuvens Screening Onderzoek). The NELSON Trial is due to report in soon.
A future exercise to combine UKLS and NELSON data is anticipated, but further data sharing will not be undertaken prior to approval from NHS Digital by means of a separate application.
Source: NHS Digital.