MR1098 - The time-course and mechanisms underlying age-related changes in arterial stiffness

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Addenbrooke's Hospital to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

The data previously supplied to Addenbrooke's Hospital by NHS IC (a predecessor to NHS Digital) will be used only for the approved Medical Research Project MR 1098.

Cardiovascular disease is now a the leading cause of death worldwide, with Myocardial Infarction and Stroke accounting for over 20% of all deaths. As we get older our arteries stiffen, this leads to an increase in blood pressure and places us at greater risk of strokes and heart attacks. Although we know that arteries stiffen with age, we don't know the precise rate of stiffing, or whether arteries stiffen more quickly the older we become.

This is a prospective longitudinal follow-up study of a large cohort of individuals to measure the rate of arterial stiffening in healthy individuals and to investigate the factors which influence arterial stiffness and a number of other key parameters which will be assessed at baseline and re-assessed after one and five years.

Study population

300 subjects aged <35 years, 300 subjects aged 35-55 and 300 subjects aged >55 years will be recruited from the researchers existing database of volunteers and from the community In addition, 300 patients with stage 2-5 chronic kidney disease (CKD) will be recruited from the renal outpatients department. This approach ensures that healthy volunteers and patients will be drawn from the same general population.

Primary outcome measure

Changes in Aortic pulse velocity (PWV) and central augmentation index (Alx) (measures of arterial stiffness)

Data requested from ONS flag study participants (1200) supply data collected at death registration including cause of death.

Ethics, Consent, Study protocol and the Study sponsor.

The study has ethical approval from Cambridge NHS REC dated 22/08/2005

Full title of study: The time-course and mechanisms underlying and age-related changes in arterial stiffness.

REC reference number: 05/Q0108/262

Participants have consented to the study and for their personal identifiable information to be processed at NHSCR (tick box) Information sheet mentions ONS/NHSCR/GRO

No mention of ONS proposed involvement in the study protocol.

Any reports, papers or statistical tables that are published or released to other organisations will fully protect the identity of individuals in accordance with current NHS Digital guidance.

The data previously supplied by the NHS IC to Addenbrooke’s Hospital will be used only for the approved Medical Research Project for the Research Project The Time-Course And Mechanisms For Health And Social Care Underlying Age-Related Changes In Arterial Stiffness.

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

The information will, be processed in accordance with the principles and conditions set out in the Data Protection Act 1998 and with proper safeguards to ensure confidentiality. The data will be held in a secure environment where any access can be traced. NHS Digital will have the right to audit the security arrangements put in place.

Users of the data supplied are obliged to abide by all relevant legislation, regulations, codes of practice, guidance and any further requirements imposed on them when accessing the shared information.

The data is categorised as Classified and will be treated by the NHS IC in accordance with NHS IC protocols for the transfer and use of NHS Classified Data.

Historic Transfer of Data between the NHS IC and the Addenbrookes Hospital:

Data Depot

• The Data was sent to Addenbrookes Hospital via the secure online Data Depot (file transfer system, used for exchanging files between the IC and external parties) to a Permitted User at Addenbrookes Hospital. The Data is encrypted to 128-bit AES when transmitted from the IC.

• For a new Permitted User at Addenbrookes Hospital taking responsibility for arrangements under this Agreement, NHS Digital will provide login details.

• For an existing Permitted User at Addenbrookes Hospital taking responsibility for arrangements under this Agreement, a notification e-mail will be sent informing that the data is available.

• The named person must not share the password with any other person at any time.

Data will be retained for 10 years.

Customer to confirm on re-submission

This Agreement permits the secure retention of the data only and no other processing.

No new outputs will be produced under this Data Sharing Agreement.

Addenbrookes Hospital to confirm on re-submission.

This Agreement permits the secure retention of the data only and no other processing.

Addenbrookes Hospital to confirm on re-submission

Addenbrookes Hospital to confirm details of of yielded benefits on re-submission