NHS Digital Data Release Register - reformatted

Institute Of Child Health projects

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


MR241 - GROWTH HORMONE THERAPY — DARS-NIC-147875-00SJY

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, Identifiable (Section 251 NHS Act 2006)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2019-08-01 — 2020-09-30 2016.12 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. MRIS - Scottish NHS / Registration
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report

Objectives:

The data supplied will be used only for the approved medical research project - MR241: GROWTH HORMONE THERAPY

Yielded Benefits:

The holding of a national database of live individuals treated with hGH enables other health care professionals, such as infection control teams, to ascertain if an individual who may be in the at risk population actually received hGH. This is relevant in relation to blood donation services, organ donation services and individuals requiring surgical procedures for whom special precautions and equipment may be needed. The continued surveillance this study has provided has shown that contrary to previously held views, the incubation period is in excess of 37 years and individuals are still at risk of CJD and presumably of transmitting it.

Expected Benefits:

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.

The CJD Unit can collate this unique data on incidence of hGH related CJD, relate this to treatment, and improve the advice given to professionals and the patients themselves, who make contact through the National Helpline.
It facilitates collaborate clinical correlations with illness details.
The individuals represent a public health risk by virtue of the transmissibility of the disease and are barred from the organ donation and blood transfusion. This cohort, and others such as those treated with contaminated Factor VIII, are the subject of national surveillance by Public Health England and the CJD Unit are the only source of information relating to the hGH recipients, updated with live data on death and cancer from NHS Digital/NHS Research/successor organisations.
The CJD Unit provide an expert national helpline for those concerned about treatment and CJD and co-ordinate the clinical care of those who develop CJD. The ability to do this is greatly enhanced by the unique current knowledge of numbers of cases. No other unit has details of the entire UK cohort.
The benefits are as follows:
• The identification of the size of risk to the general population of the risk of transmission of pit-hGH CJD
• The identification of any additional potentially transmissible diseases
• The identification of co-morbidities associated with pit-hGH and potentially prophylactic intervention
• Identification of any links between administration of particular types of pit-hGH and CJD and other co-morbidities
• Consideration of the underlying cause of growth hormone deficiency and pit-hGH treatment in relation to development of CJD and other co-morbidities
The formal outputs will quantify and disseminate to the Public Health England the risks outlined previously
Likely changes:
• Public Health England might reinforce advice to blood transfusion centres
• Public Health England might update and reinforce organ donation advice
• If a link with other transmissible diseases or co-morbidities is identified and treatment is available information can be provided to relevant health care professionals
• Public Health England and Primary Care Physicians would be responsible for the above
• Public Health England and Primary Care Physicians would be responsible for measuring any benefit

Outputs:

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.

The research team analyses the data on a three-monthly basis for trends in mortality and cancer registrations. A six monthly summary report of anonymised aggregated data is supplied for Public Health England including number of live patients and age bands and annual report to the DHSC summarising number of cases of CJD, number of patients alive and any trends in mortality or morbidity.

If the data appears to suggest an increase in for example deaths from haemorrhagic stroke there would be a case for advising the at risk patients and their primary care physicians of this, as lifestyle or pharmacological interventions might reduce the risk of events. However such action would need to be considered in a multidisciplinary fashion, assessing the individuals best interest.

If new risks are identified, there could be a wish to publish summary results in academic literature. This would be important if there are findings which indicate that the cohort is at risk of illnesses which might be prevented or ameliorated if awareness were to be raised. These include lifestyle changes, monitoring, medication.

Historically where trends have been identified, anonymised data has been shared with appropriate researchers and led to publications.

Aggregate anonymised data with small numbers suppressed will be contained in all outputs.

Processing:

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). No new or further data will be provided under this version of the agreement.

A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.


Under a previous iteration of this Agreement, NHS Digital supplied mortality data from 1985 to March 2017.Identifiers supplied to NHS Digital to flag the cohort were NHS Number, date of birth and last known address, it is not expected any new individuals will be notified.

Under this agreement cancer diagnosis and cause of death in the cohort will be supplied and there is no planned flow of data from the Growth Hormone Therapy study.

Access to the data will be restricted to members of the research team employed by Great Ormond Street Hospital who are specifically assigned to work on this study. The data will be used exclusively for the purposes of the specified study and none of the patient identifiable data supplied by NHS digital to the data processor will be shared with others.

At the end of the study, the data will be safely held on a password protected and encrypted drive at Great Ormond Street Hospital, for further 5 years, and accessed only to answer questions arising from the publication and other publicity if required. This will be the subject of a new agreement with NHS Digital.

The data processor, lead for the study, maps the patient identifiable data to the individual records of the cohort. Only aggregated data is shared with other parties.

The data processor will enter the personal data received from NHS Digital relating to individuals into a secure database containing the personal information about the cohort. This data is required to track and ensure correct identification. Periodic analysis of the database provides aggregated anonymised outputs for PHE and DHSC, these reports are biannual, dated end of June to end of December each year. The regular NHS Digital updates are taken into the analysis each time.

The patients are already known and identified. No new patients will be identified.
The data processor is GOSH and is the only organisation with access to the data.

All data is stored secured on the GOSH computer network, password accessible to the data processor from within the hospital or using secure remote access.