NHS Digital Data Release Register

NHS Digital Data Release Register - reformatted

University of Leeds

Opt outs honoured: N

Basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Format: Identifiable Non Sensitive

How often: Ongoing

When: unknown — 11/2016

HSCIC Id: DARS-NIC-147908-CPCPG-v0.0

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Cause of Death Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Flagging Current Status Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Scottish NHS / Registration

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Scottish NHS / Registration

Data: Hospital Episode Statistics Accident and Emergency

Data: Hospital Episode Statistics Admitted Patient Care

Data: Hospital Episode Statistics Outpatients

Data: Mental Health and Learning Disabilities Data Set

Data: Hospital Episode Statistics Admitted Patient Care

Data: MRIS - Flagging Current Status Report

Data: MRIS - Cause of Death Report

Data: Hospital Episode Statistics Admitted Patient Care

Data: Hospital Episode Statistics Accident and Emergency

Data: Mental Health Minimum Data Set

Data: Mental Health and Learning Disabilities Data Set

Output: The primary and secondary analyses from the SHIFT trial will be published as an HTA monograph (SHIFT is funded by the Department of Health’s National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. It is a key funder for a lot of large scale research projects across England. One of the requirements of conducting research funded by HTA is that a 50,000 word monograph (or report) is produced at the end of the study, providing detailed evidence of processes undertaken, trial results, interpretation and dissemination plans. The HTA monograph is due for submission March 2016, with an anticipated publication date of October 2016.

The findings will be submitted to relevant peer reviewed journals in the field of child and adolescent mental health and self-harm. There is the intention to more widely disseminate trial results to patient and public groups and to the lay community. The intention is to meet with a young person’s lay group in London (the same group they consulted regarding the newsletter) the National Institute for Health Research’s (NIHR) Young People’s Mental Health Advisory Group. At this forum the results will be presented and questions will be asked for their advice on interpretation from a lay perspective, and also their thoughts on where and how results would best be disseminated.

It is a condition of NIHR funded research that results are disseminated widely and appropriately and not just in academic journals – lay dissemination will be initiated at the meeting with the above group and their advice sought. The SHIFT trial will also look at other existing patient forums – local and national – for oral dissemination, as well as via charitable organisations (such as Young Minds) and local / national lay publications in which they might be able to include suitable articles.

In all cases this would be a summary of findings including the implications of these.

In summary results will be published in usual academic routes, papers in journals, presentations in conferences;

Newsletter to all participants (unless they have told us they don't want this) and to all participating staff;

Information on study web site;

Press releases and possible involvement of national media;

A special conference will be organised in Leeds for all the clinical colleagues who were involved.

The University of Leeds also want to do something with the young people and their families. Exactly what is still under discussion, consultation is still underway with YoungMinds and the NIHR CAMHS user group. This will influence wording of newsletters/ websites etc.

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.

No outputs will ever identify any individual and be aggregated with small numbers suppressed, organisation, nor include any record level data.

Activities: Data will be processed by the trial statisticians at the Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research (LICTR) at the University of Leeds. It will be securely stored on CTRU systems with access only granted to the statistical team. Data will not be accessed by any third parties, nor will it be accessible across multiple organisations. LICTR has IG toolkit status (Code: ECC0010).

Identifiers will be sent to the HSCIC (Trial ID, postcode, NHS number, gender and Date of Birth). Data will be linked with existing SHIFT Trial datasets (data provided by participants and researchers in accordance with the REC-approved trial protocol and participant consent), as per the existing agreement with HSCIC that this data will augment the dataset with data that is difficult or impractical to obtain from individual NHS organisations. The linked data will be returned, containing identifiers, back to the University of Leeds and only accessed by a named statistician before it is stored in the networks.

Data will not be used for any other purposes: it will not be used for commercial purposes, nor for direct marketing purposes.

All individual accessing or processing the data are employees of the University of Leeds.

Objective: The SHIFT (Self-Harm intervention Family Therapy) Trial has been designed as a pragmatic, individually-randomised, controlled trial comparing Family Therapy (FT) with Treatment as Usual (TAU) for adolescents aged 11 – 17 years who have engaged in at least one previous episode of self-harm. The trial aims to recruit 832 participants from centres in Yorkshire, Greater Manchester and London. Family therapy will be delivered by qualified family therapists using a modified version of the Leeds Family Therapy & Research Centre Systemic Family Therapy Manual (LFTRC Manual), the development of which was funded by the MRC to support trials of FT. The primary outcome is rate of repetition of self-harm leading to hospital attendance 18 months after randomisation. Secondary outcomes include rate of repetition at 12 months, cost-effectiveness, quality of life, and predictive/process measures.

Data will be processed alongside other data collected for SHIFT Trial participants to form the final data set for trial analysis. 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); ONS mortality data will inform the safety and population profile; MHLDDS data will enable a fuller description in the trial results of, and accounting for, services accessed by participants. All publications and reports to external bodies utilising the data will be fully anonymised; participants will only be identifiable to the trial team (who are already in receipt of full identifiers by virtue of existing data provided by and for participants).

Data will not be shared with third parties.

Benefits: 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 of this year, so statistical analysis is underway.

Once the data is 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 this 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 - in 2016/17.

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.

Source: NHS Digital.