SHIFT Trial Participant Data MR1384

The aim and purpose of this agreement is to continue to process data on participants recruited to the SHIFT (Self-Harm intervention Family Therapy) Trial. This is so analysis can continue on the hypothesis, and data can be retained incase of queries that arise from publications. The sole data controller is the University of Leeds. The legal basis for dealing with people’s personal data for research data, like with the SHIFT study, is ‘task in the public interest’, or in other words, the SHIFT study are collecting data that the study needs in order to complete this specific research, which aims to improve healthcare for the general public. This is line with Article 6 (1)(E) of the General Data Protection Regulation.

The SHIFT trial is ethically approved and received funding from public bodies (i.e. the National Institute for Health Research). The SHIFT trial collected data about people’s health, which is by law a ‘special category’ of personal data and the lawful basis for the use of this data is necessary for scientific research purposes. This is line with Article 9 (2)(J) of the General Data Protection Regulation.

The SHIFT trial compared Family Therapy (FT) with Treatment as Usual (TAU) for adolescents aged 11 – 17 years who engaged in at least one previous episode of self-harm. The trial recruited 832 participants from centres in Yorkshire, Greater Manchester and London. As well as the young person, their main caregiver (for example, Mum or Dad) also took part. (Only identifiers of the young people were flow to NHS Digital). If they both agreed they were then randomly allocated to either family therapy or the usual treatment in their local CAMHS. Family therapy was delivered by qualified family therapists using a modified version of the Leeds Family Therapy & Research Centre Systemic Family Therapy Manual. University of Leeds followed the young person and their main caregiver for 18 months to collect the primary outcome, repetition of self-harm leading to hospital attendance, and secondary outcomes including cost-effectiveness and quality of life.

The trial reached its target of 832 participants recruited on 30th December 2013.

The primary outcome was rate of repetition of self-harm leading to hospital attendance 18 months after randomisation. Data obtained from NHS Digital is processed alongside other data collected for SHIFT Trial participants, that is from researcher-collected data direct from medical notes, to form the final data set. Specifically: HES APC & A&E data will inform the primary outcome of the trial (hospital attendance following self harm) and the safety profile of participants (hospital attendance for any reason); mortality data will inform the safety and population profile; MHLDDS data enable a fuller description in the trial results of, and accounting for, services accessed by participants. Identifiable data was sent to NHS Digital, in line with the patient information sheet, to allow for the data to be linked with the trial dataset. The number of years requested was in line with the timelines for the trial endpoints. No new data is required for this cohort of participants under this Version of the Data Sharing Agreement and there is no contact with the participants. The trial specific website is periodically updated when something changes.

The SHIFT trial also includes a cost-effectiveness analysis, which was performed by Health economists at the University of Leeds. Data required for use by health economics was transferred by a Clinical Trials Research Unit Statistican to a named Health Economist at the University of Leeds. This data will continue to be processed and stored at the University of Leeds in a separate department.

The SHIFT trial is funded by the National Institute for Health Research Health Technology Assessment (reference number - 07/33/01) and commenced in 2008. The SHIFT trial was a collaboration between University of Leeds, King’s College London and University of Manchester. Only University of Leeds are still involved. The University of Leeds is sponsor, grant holder and has overall responsibility for the research and determining the purpose and methods used to process information collected for this project. All publications and reports to external bodies and the collaborating groups utilising the data is fully anonymised; participants will only be identifiable to the trial team at the University of Leeds (who are already in receipt of full identifiers by virtue of existing data provided by and for participants).

Data will only be accessed and processed by substantive employees of The University of Leeds and will not be accessed or processed by any other third parties not mentioned in this agreement. In the event that data is accessed by personnel who are not a substantive employee of the University of Leeds, an honorary contract will be in place and approved by NHS Digital prior to the data access.

All organisations party to this agreement must 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).

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

Data will only be accessed and processed by substantive employees of the University of Leeds and will not be accessed or processed by any other third parties not mentioned in this agreement.

When data has been analysed and results presented for publication or dissemination - the following rules will apply:

• National-level figures only may be presented unrounded, without small number suppression

• Suppress all numbers between 0 and 5

• Round all other numbers to the nearest 5

• Percentages can be calculated based on unrounded values, but need to be rounded to the nearest integer in any outputs.

• In addition for the Learning Disability data in Mental Health (MHSDS, MHLDDS, MHMDS), the England-level data also must apply the suppression of all numbers between 0 and 5, and rounding of other numbers to the nearest 5.

There will be no attempts to relink the data to identify participants in the study.

When the linkage was first initiated - the following identifiers were flown to NHS Digital: Study ID, NHS Number, Date of Birth, Postcode, Gender. No further identifiers will be sent to NHS Digital, and no new data will be disseminated under this version of the agreement.

Data is processed by the trial statistician and researchers at the University of Leeds. It is securely stored on Clinical Trials Research Unit (CTRU) systems with access only granted to authorised members of the research team. Data will not be accessed by any third parties, nor will it be accessible across multiple organisations.

Leeds Institute of Clinical Trials Research is compliant with the Data Security and Protection Toolkit.

Data has already been obtained from NHS Digital and linked with existing SHIFT Trial datasets (data provided by participants and researchers in accordance with the REC-approved trial protocol and participant consent). The data is only accessed by members of the research team and is stored on a secure network. Data will not be used for any other purposes not mentioned in this agreement: it will not be used for commercial purposes, nor for direct marketing purposes.

All individuals accessing or processing the data will be based at the University of Leeds. Data will only be accessed and processed by substantive employees of The University of Leeds have been appropriately trained in data protection and confidentiality. and will not be accessed or processed by any other third parties not mentioned in this agreement. In the event that data is accessed by personnel who are not a substantive employee of the University of Leeds, a honorary contract will be in place and approved by NHS Digital prior to the data access.

The primary and secondary analyses from the SHIFT trial have been published as an HTA monograph and are freely available via the NIHR Journals library (accessible here: https://www.journalslibrary.nihr.ac.uk/hta/hta22120/#/full-report).

The findings of the main trial, and longer term follow-up, were published in February 2018 (accessible here:

https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(18)30058-0/fulltext).

A lay summary of the trial results is also available on the SHIFT trial website (accessible here: https://ctru.leeds.ac.uk/shift/).

A conference was held in Leeds in November 2016 for all the clinical colleagues who were involved.

The intention, should the trial show that the intervention is effective, is that the results will ultimately inform NICE guidance and influence NHS practice in this area. However, the trial did not show that the intervention was effective. This contributed to a commissioned call from the NIHR HTA (HTA no 17/117) - Therapeutic interventions for self-harm in adolescents - an individual patient data meta-analysis. This project has been awarded to the University of Leeds. Further work, which may be subject to a further NHS Digital DARS application will be carried out.

No outputs will ever identify any individual and all will be aggregated with small numbers suppressed. Outputs will also not identify any organisation, nor include any record level data.

Methodological output exploring the reliability and accuracy of Hospital Episode Statistics, compared to data collected directly from hospital records, to assess whether it would provide complete, accurate, and reliable means of acquiring hospital attendances, was published in March 2018 (accessible here: https://doi.org/10.1177/1740774517751381).

Sharing data when the research has finished

Collecting data for research takes a lot of time and money to do. One way the SHIFT study can get the most benefit from this work is to make data available, when the research has finished, to other researchers who would like to use it for other research projects. These other researchers may be at the CTRU or University of Leeds, or in other organisations such as universities, NHS organisations or companies involved in health and care research. They may be in the UK or abroad.

If the SHIFT study get requests to use the research data, they will only agree to share it for valid and worthwhile research projects in healthcare or medicine. The shared data does not identify individuals and is not combined with other data in a way that means individuals could be identified. Data is only shared with qualified researchers who agree to store data securely. If the data to be shared includes NHS Digital data, SHIFT will seek the necessary approval from NHS Digital prior to any sharing of data. The SHIFT website will be updated with details of any sharing of data.

Shared data cannot be used to contact individuals and does not affect anyone’s care. It is not used to make decisions about future services available to individuals, such as insurance.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

The SHIFT Trial was commissioned by the Department of Health via their National Institute for Health Research (NIHR) funding stream.

The primary purpose of conducting research like this is to inform NHS practice. The trial design is such that the ‘primary outcome’ is hospital attendance following self-harm 18 months after trial entry – what this means is that the University of Leeds will compare hospital attendances for the group of young people who received family therapy and the group who received usual care. The University of Leeds can only make this statistical comparison when everyone in the trial has been involved for 18 months. This is now the case – the last participants completed follow up in June 2015, so statistical analysis is complete and main 18-month follow-up results have been published (HTA monograph and main journal paper).

Once the data is fully analysed the University of Leeds will have the results showing whether or not family therapy was better than usual treatment. Whatever the outcome there will be some benefit to the NHS and to people using NHS services. A review of the NIHR report and other literature will inform NICE guidance which in turn will influence NHS commissioning.

A positive outcome showing that family therapy is more effective than current usual care would influence NICE guidance for best practice within the NHS. This would be established after publication of the main results.

If family therapy is shown to be no better than standard care, the results will provide other valuable insights which will assist commissioners. For example, it may be that family therapy is does not lead to a decreased number of hospital attendances however, the results will show whether it is more or less cost effective overall. If it is worse or better, this will be similarly disseminated to inform practice.

Longer term follow-up of SHIFT participants to a minimum of three years (for last recruited participants, up to six years for first recruited participants) was further funded through the National Institute for Health Research (NIHR) funding stream to establish the longer term outcomes for participants, and whether any effects are sustained. Final follow-up is due to take place in April 2017.

The gender differences study is a secondary analysis and findings and recommendations will be shared with Child and Adolescent Mental Health Services (CAMHS) teams through local presentations and teaching sessions.

- Publication of results (HTA monograph and academic publication)

- Contributing to the evidence base to support commissioning of an individual patient data meta-analysis with the aim to identify subgroups of adolescents in whom a therapeutic intervention for self-harm shows some evidence of benefit in order to guide future primary research.