NHS Digital Data Release Register - reformatted

Society of Endocrinology

Project 1 — DARS-NIC-147893-ZFLWG

Opt outs honoured: No - consent provided by participants of research study (Reasonable Expectation, Consent (Reasonable Expectation))

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/12.

Repeats: Ongoing, One-Off

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable

Datasets:

  • MRIS - Members and Postings Report
  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Yielded Benefits:

The study has already greatly enhanced the studies clinical understanding of Acromegaly and has informed best practice. Patients across the UK will already be benefiting from positive changes to their treatment pathways. Some examples of the findings are given below: • An assessment of control & responses to certain medications gave a greater understanding of which were adequate and in what proportion of patients. • Radiosurgery data showed Gamma knife radiosurgery after neurosurgery to be a safe and effective long-term adjunctive treatment for pituitary tumours that cause acromegaly. • Radiotherapy data concluded conventional pituitary irradiation to be an effective and safe means of reducing growth hormone levels. • Unsuccessful surgery for acromegaly has major consequences for the patient and financially for the NHS. A study of the surgical data collected showed surgeon experience to be an important determinant of surgical success. Recent improvements in success rates coincide with the trend to now concentrate pituitary surgery amongst a smaller number of specialist surgeons.

Objectives:

Acromegaly is associated with increased morbidity and mortality, due largely to cardiovascular, cerebrovascular and probably malignant disease. The incidence of acromegaly is reported to be between 4-6 new cases per million per year with a prevalence of approximately 40-60 per million. This equates in the UK to around 2,500 patients with acromegaly. Due to its comparative rarity no one centre can provide sufficient numbers of patients to enable analysis with sufficient statistical power. Therefore the UK Acromegaly register was established in 1997.

Expected Benefits:

Due to its comparative rarity, no one centre can provide sufficient numbers of patients to enable analysis of potential influences on mortality and morbidity of, for example a) Pre-existing co-morbidities, e.g., diabetes mellitus and hypertension, b) Different treatment modalities, e.g., pituitary radiotherapy and different growth hormone levels. In particular, there is only one publication relating mortality to IGF1 data. The benefit of being able to obtain the data from NHS Digital to support the study aim will inform the day to day management of patients with acromegaly and to encourage centres to audit their practice against the national dataset.

Outputs:

PRIMARY MEASURE OF OUTCOME: To provide epidemiological evidence about long-term mortality and morbidity and the results of treatment by surgery, radiotherapy and medical therapy in acromegaly. SECONDARY OUTCOME MEASURES: To inform on the day to day management of patients with acromegaly and to encourage centres to audit their own practice against the national dataset. Outputs will be published in peer-reviewed journals, presentated at national and international meetings (to include The Society for Endocrinology BES annual conference) and a summary of the results will also be sent to the patient support group, The Pituitary Foundation. www.pituitary.org.uk. Outputs are due in 2018 and all outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Local hospital staffs add patient details and clinical data to the UK Acromegaly Register remotely. Data is stored at the Society for Endocrinology Office in Bristol. The data needed by NHS Digital to return death/cancer registration information is collated within the Society for Endocrinology Office in Bristol by those named as ONS users only. Data is submitted to NHS Digital – DARS. This includes: NHS number, forename, surname, date of birth and sex. NHS Digital -DARS process and release data to Society for Endocrinology. The person receiving the data has been approved by NHS Digital. Data is uploaded to the UK Acromegaly Register and stored at the Society for Endocrinology Office in Bristol. All data analysis of record-level data is undertaken at the Society for Endocrinology office in Bristol. Only identifiable data necessary for the analysis is made visible to the statistician e.g. it is not possible to report the distribution of age at death without providing date of birth and date of death for each individual. Where an identifiable field is absolutely necessary, this is pseudonymised e.g. each participant is given a unique identifying number in place of their NHS number, forename and surname. Once data has been pooled in to aggregated tabular form with small numbers suppressed, the data will be further processed at Newcastle University for publication in peer-reviewed journals, presented at national and international meetings and lay information provided to patient support groups. The Society for Endocrinology confirm that no record level data will be accessed or processed outside of the Society for Endocrinology office in Bristol. ONS Terms and Conditions will be adhered to. There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement. 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).


Project 2 — DARS-NIC-148364-RHMHS

Opt outs honoured: N

Sensitive: Sensitive

When: 2018/03 — 2018/09.

Repeats: Ongoing, One-Off

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable

Datasets:

  • MRIS - Members and Postings Report
  • MRIS - Cause of Death Report

Objectives:

The data supplied by the NHS IC to Royal Hallamshire Hospital will be used only for the approved Medical Research Project identified above.