Yorkshire Ambulance Service NHS Trust

NIHR158676

Mixed methods study to understand the scale, impact and care trajectory for patients who have a long lie after a fall.

Methods - Mixed methods

Fiona C Sampson (https://orcid.org/0000-0003-2321-0302)

Maxine Kuczawski

The University Of Sheffield has a Data Protection Policy regarding handling and securing special category data in accordance with GDPR and the Data Protection Act (2018). This includes the safeguarding and processing of special category data, with university level measures for accountability; lawful, fair and transparent processing; data minimisation; accuracy; storage limitation and security. https://www.sheffield.ac.uk/govern/data-protection/appropriate-policy-document

The study settings will be UK wide (community care, ambulance service trusts, and academic hospitals) using hospital (including emergency department), care home and residential homes as study settings.

The study consists of seven work packages:- WP1: Using the CUREd+ dataset which includes linked anonymised routine healthcare data from the ambulance service, NHS111, emergency departments (EDs), acute hospitals and mental health services, patients that have experienced a long lie following a fall over a period of 24 months (Jan 2020 - Dec 2023) will be identified. These index cases will be followed up for a minimum of 12-months to understand the incidence of long lies after a fall, the management of the patient, patient characteristics and their care trajectory. The CURED+ data extract will be produced by Data Connect at the University of Sheffield (UOS), and made available to named members of the research team via a secure data environment for analysis. WP2: Utilising the data used in WP1 (CURED+ dataset), an economic analysis will be performed to estimate the resource use and costs associated with a long lie. As WP1, the CURED+ data extract will be produced by Data Connect at the UOS, and made available to

WP1: Data Connect will provide the CURED+ data extract in an accessible format for use with the statistical software R or Stata, such as .dta. It is estimated there will be a minimum of 115,000 cases, with approximately 16,000 having a documented long lie during the period of interest. WP2: As above, Data Connect will provide the CURED+ data extract in an accessible format for use with the statistical software R or Stata, such as .dta. It is estimated there will be a minimum of 115,000 cases, with approximately 16,000 having a documented long lie during the period of interest. WP3 (several parts): a) Hospital notes review (n=200). This will include patient demographics, incident details, injuries experienced, treatment received, changes in patient care needs and discharge information. Text data will be extracted and recorded in an electronic form created in Microsoft Forms and will be exported using different formats as appropriate such as .html, .xls, .csv, etc. WP4: (several parts) a) Structured survey (n=

Data extracts utilised and manipulated in WP1 and 2 will go through a quality assurance process before analysis. Quality assurance of notes and transcripts will be conducted by members of the study team by listening back to recordings and checking the accuracy of notes and transcription before deletion of the audio/ video files. Transcripts will be annotated to ensure clarity of meaning and avoid misinterpretation in analysis. These meanings will be double checked with the interviewers in the case of any ambiguity or uncertainty.

The research data collected in WP3 will be deposited in a restricted-access study folder on NHS and YAS shared networked filestore. This will only be accessible to specific researchers who have a need to access the data. Data is automatically backed up by the NHS and YAS data servers. Data is stored according to the NHS and YAS Information Governance Policies. All NHS and YAS staff must complete the relevant data security and information governance training in order to access the NHS and YAS servers. We will comply with the Data Protection Act and the NHS/ YAS own Information Security and Data Protection policies. Access is controlled by authorised NHS computer account username and password and uses multi factor verification. Off site access to the restricted-access study folder on YAS shared networked filestore are facilitated by a cloud-based YAS research-specific Sharepoint site and is authenticated by YAS username, remote password and multi-factor verification. The research data collected and used in WP

The study data conducted by the UOS (WP1, 2, 4, 5, 6 and 7) will be stored in a restricted-access study folder on UOS shared networked filestore. Only authorised members of the study team will have access to this folder which will be accessed through UOS system using their unique username and password. Access to these folders for members of the study team that are not employees of UOS will be requested from IT Support (UOS). Case report data submitted in the online form at hospital sites (WP3) will be stored electronically according to the organisations' (YAS and NHS hospital sites) Information Security and Data Protection policies. It will only be accessible to NHS and YAS staff involved in the study. The case report data will be collected and submitted to an online form by hospital staff (with NHS email addresses) with patient study ID applied. Once an online form is submitted, hospital staff will not be able to access the information which will be stored in YAS research Sharepoint sites with access limit

Case report data submitted in the online form at hospital sites (WP3) will be stored electronically according to the organisations' Information Security and Data Protection policies and accessible to only those NHS staff involved in the study. The case report data will be shared between hospital sites and YAS using unique study identifiers and excluding personal identifying variables. The case report data will be collected and submitted to an online form by hospital staff (with NHS email addresses) with patient study ID applied. Once an online form is submitted, hospital staff will not be able to access the information which will be stored in YAS research Sharepoint sites with access limited to authorised YAS staff only. Analysis of this data will be undertaken by authorised YAS staff. Any communication between NHS hospital and YAS staff regarding the study will take place using telephone or NHS-NHS secure email, using password protection on documents where appropriate. For the purposes of patient interview

Information collected via the online Qualtrics survey software (WP4c) will be downloaded or transferred as soon as possible into the restricted-access study folder on UOS shared networked filestore. At the completion of the study, the study folder in the Qualtrics account (containing study data) will be closed and study data deleted. The restricted-access study folder on UOS shared networked filestore will be designated with a 'time to live', projected to be a maximum period of 12 months, after which any personal identifying data (name and contact details) stored will be removed. Additionally, consent forms (paper and electronic versions) will be destroyed. Outputs of the study, including the final report, will be uploaded to the UOS Data Repository, compliant with FAIR data principles. Embargos will apply where appropriate prior to publication of findings. Data extract(s) utilised in WP1 & 2 are subject to the terms and conditions set out by Data Connect, which restricts the use to the study team only. Data

Data Connect will provide the CURED+ data extract in an accessible format for use with the statistical software R or Stata, such as .dta. Statisticians will then use this software for analysis (WP1 and 2). Microsoft Excel will be used for any quantitative data collection and analysis in WP4-7. NVIVO will be used for analysis of qualitative data (WP4-7).

Maxine Kuczawski is responsible for all data management tasks including implementing, reviewing and revising the DMP.

Appropriate resources (staff time, associated costs) were calculated and built into the study plan, this includes obtaining data extract(s) from Data Connect for use in WP1 & 2. It is not expected that any additional resources will be needed for data preparation for depositing.