NHS Digital Data Release Register - reformatted

Royal Surrey County Hospital NHS Foundation Trust

Opt outs honoured: Yes - patient objections upheld (Section 251 NHS Act 2006)

Sensitive: Sensitive

When: 2020/04 — 2020/04.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report

Objectives:

The prostate Brachytherapy programme at the Royal Surrey County Hospital NHS Trust (RSCH) commenced in 1999. Since then over 3800 patients have been treated for Prostate cancer with Brachytherapy. Brachytherapy is a form of radiotherapy where a sealed source is placed inside or next to an area requiring treatment. It is commonly used as an effective treatment for a range of tumours and may be delivered as an in-patient or outpatient service depending on the procedure. Since the inception of the prostate cancer Brachytherapy programme, details of patient treatment and clinical outcomes have been held on an anonymised database at RSCH, called Brachybase. Following Brachytherapy, patients are followed up every 6 months for 5 years, and annually thereafter. The average age at treatment is 70, meaning that a number of patients that were treated have died since the start of the prostate Brachytherapy programme. This agreement pertains to an internal audit of survival outcomes for approximately 250 patients who have received low dose rate prostate Brachytherapy for the treatment of prostate cancer. These patients have been lost to follow up as most of them came from outside the Trust area, and because 73% were treated over 10 years ago (2000 to 2007). A query to NHS Spine (the national patient database) has shown these patients’ mortality status to be deceased (all patients in the cohort were treated at the hospital in the same department). Although the date of death of the patient cohort in question was confirmed by NHS Spine, the causes(s) of death are not known by RSCH. This additional information is required to audit Prostate Cancer Specific Survival following Brachytherapy. This information is required to update the “cause(s) of death” on the Brachybase database at RSCH and generate survival statistics for the internal audit on prostate Brachytherapy clinical outcomes. The data that is required is the cause(s) of death as documented in death certificates of patients who have died after receiving prostate Brachytherapy and have been lost to follow up during the 20 years since prostate Brachytherapy treatment. This is for approximately 250 patients, there is no control group. This is an internal audit. It is not part of a longitudinal research study and is not externally funded. Knowledge of prostate cancer specific survival will help define the efficacy of prostate cancer care in the RSCH. It will also enable comparison with results reported from other centres worldwide and thus attest to the generalisability of the results. Clinical audit is one of the cornerstones for evidence-based healthcare. This is considered good clinical practice and does not raise moral or ethical issues in this case. All patients in the cohort are deceased. Approval has been granted by the Confidentiality Advisory Group (CAG) for identifiable information (full name and date of birth) to be sent to NHS Digital by RSCH and for causes of death data to be sent from NHS Digital to RSCH. There will only be cause of death data contained in the extract - no further information relating to coroners or consultants will be contained. The purpose of this request is to evaluate treatment quality and outcomes of cancer care, to ensure high quality evidence-based healthcare (NHS act 251= medical research, the provision of care and treatment and the management of health and social care services). Patients who received Brachytherapy treatment at RSCH have been followed up indefinitely due to the protracted nature of prostate cancer. The causes(s) of death for the small cohort of patients lost to follow up are not documented in the Brachybase. This additional information is required to audit Prostate Cancer Specific Survival. This requested mortality data will show whether the cohort lost to follow up died of prostate cancer, with prostate cancer, or free from prostate cancer. This will attest to the efficacy of the Brachytherapy treatment. This is a one-off audit from the beginning of the programme 20 years ago. Royal Surrey Hospital is a tertiary reference centre and the Brachytherapy programme has treated patients from all over the UK. Therefore, the data will be for patients from all over the UK. The data requested is minimised as it is limited to the cohort of approximately 250 male patients who were all treated with Brachytherapy at RSCH for prostate cancer. There are no less intrusive ways of obtaining this information. RSCH is the sole organisation that processes data no other organisations are involved. The data will be stored and processed at Royal Surrey County Hospital. The Prostate Project Charity is supporting the audit from a Patient User Organisation perspective. The charity does not have any direct interest in funding or organising the Brachytherapy programme, they are not involved in the design, execution or have any influence over any outputs other than to assist in the promotion of the dissemination's via its networks. All organisations party to this agreement must comply with the Data Sharing Framework Contract, including requirements on the use (and purposes of that use) by "Personnel" (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data). The data received by Royal Surrey County Hospital NHS Foundation Trust will not be used for any purpose other than to meet objectives as stated in this Data Sharing Agreement and will not be shared with any other third party or organisation.

Expected Benefits:

Estimates of disease specific survival are necessary to define treatment efficacy. Knowledge of prostate cancer specific survival will help define the efficacy of prostate cancer care in The Royal Surrey County General Hospital. It will also enable comparison with results reported from other centres worldwide and thus attest to the generalisability of the results. Clinical results from the Brachytherapy programme have previously been published in journals such as British Journal of Urology, European Urology, Journal of Clinical Oncology, International Journal of International Journal of Radiation Oncology Biology Physics, Radiotherapy and Oncology amongst others. The results obtained from the cause of death data are expected to confirm that prostate Brachytherapy is a safe, efficacious and cost-effective treatment for localised prostate cancer. Knowledge that is gained from this research will be applied when designing treatment paths and training staff. Cost effectiveness studies on prostate cancer treatments from NHS perspective are rare, so these results could well be used for such studies. 42,975 men were diagnosed with prostate cancer in England and Wales between 1st April 2016 and 31 March 2017 three quarters of these patients had localised cancer. A key benefit to this research is that it generate knowledge and outputs that can be built on - that ultimately may enable/facilitate cost effective studies on prostate cancer treatments to be carried out.

Outputs:

Results of the internal audit will be used for reports, submissions to peer journals, presentations and conferences. Outcomes information will also be made available to clinical staff at Royal Surrey County Hospital by means of the newsletter and on the Prostate Project Charity website. The Prostate Project Charity is involved with patient awareness for all the treatments offered at RSCH and the research that is carried out. This is why the outcomes of the audit will be published on its website. The charity does not have any direct interest in funding or organising the Brachytherapy programme, they are not involved in the design, execution or have any influence over any outputs other than to assist in the promotion of the dissemination's via its networks. The reason for dissemination is “good clinical practice” and information to the scientific community, policy makers and the general public regarding the outcomes of prostate Brachytherapy as a treatment for prostate cancer. The first publication is expected 3 months after reception of the data from NHS Digital, in Spring 2020. This particular audit is only for a small number of patients on the Brachybase, however it is anticipated that the results could possibly have an impact on the determined efficacy of Bracytherapy. No identifiable data will be used in any of the reports, submissions to peer and scientific journals, presentations or conferences. Only data that is aggregated with small number suppression applied will be used in published outputs. Long term results for prostate cancer treatments are of vital interest to the scientific community, policy makers and the public at large. Clinical results from the Brachytherapy programme have previously been published in journals such as the British Journal of Urology, European Urology, Journal of Clinical Oncology, International Journal of Radiation Oncology Biology Physics, Radiotherapy and Oncology amongst others. As soon as the data is received from NHS Digital, The Royal Surrey County Hospital will update the Brachybase. RSCH will then proceed to produce survival statistics for the full cohort of all patients treated with Brachytherapy (currently 4000) who have been treated since the beginning of the programme 20 years ago. A paper will be written on this and will be submitted to one of the journals mentioned.

Processing:

Royal Surrey County Hospital NHS Foundation Trust is the sole data processor in this agreement. Data sent from NHS Digital to RSCH will refer to cause(s) of death from death certificates of a cohort of patients treated with prostate Brachytherapy at RSCH. All data from NHS Digital will be processed within the Royal Surrey County Hospital NHS Trust, and then destroyed according to NHS Digital policies. Only “causes of death” information will be sent from NHS Digital to RSCH. The data disseminated from NHS Digital will be uploaded to the Brachybase Registry that is held in the Urology Department of the Royal Surrey County Hospital and managed by members of the Urology Department staff. Only members of staff who are appropriately trained in data processing and confidentiality will carry out data processing. The data supplied by RSCH to NHS Digital is that of patients who are deceased and is for an internal non -research audit. Forename, surname and date of birth will be sent from RSCH to NHS Digital for linkage purposes. The data flowed out of NHS Digital to RSCH will be cause of death for the patients whose details were sent in by RSCH. The data from NHS Digital will be added to the Brachybase: RSCH’s de-identified clinical database for data pertaining to treatment and follow up for patients who have undergone Brachytherapy for prostate cancer. The data will be destroyed once the data sharing agreement has expired according to NHS Digital policies. The Brachybase is de-identified, meaning it contains no personal identifiers, each patient is identified by a unique Brachybase ID. Patient full name and date of birth for the cohort will be sent to NHS digital along with the unique Brachybase IDs. The cause(s) of death will then be sent back to RSCH by NHS Digital, alongside the Brachybase ID codes. This mortality data sent to RSCH by NHS Digital will then be uploaded on to the Brachybase. The data that was sent from NHS Digital will then be destroyed. There will be no attempt made to re-identify individuals from the data set. Data processing will only be carried out on secure systems by substantive employees of RSCH who have been appropriately trained in data protection and confidentiality. All the databases and data at RSCH, including the Brachybase, are backed up nightly to a secure dedicated network-attached storage server hosted in a geographical separate (but still on-site) server room. Access and security for the backup server is the same as for the main storage server. All server rooms are key-card access to authorised and trained staff only.